{"id":57521,"date":"2018-12-05T01:00:00","date_gmt":"2018-12-07T02:24:03","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/12\/07\/ed57ced425\/"},"modified":"2018-12-07T10:24:10","modified_gmt":"2018-12-07T02:24:10","slug":"ed57ced425","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/57521\/","title":{"rendered":"\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u4e13\u5bb6\u4ee5FDA\u6279\u51c6\u7684\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e3a\u4f8b\u8c08\u9ad8\u7aef\u53e3\u670d\u56fa\u4f53\u7f13\u63a7\u91ca\u5236\u5242\u5f00\u53d1"},"content":{"rendered":"<div class=\"bpp-post-content\">\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;text-indent: 0em;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 14px;color: rgb(255, 169, 0);box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7f16\u8005\u6309\uff1a<\/strong><\/span><span style=\"max-width: 100%;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u300a\u836f\u5b66\u8fdb\u5c55\u300b2017\u5e74\u7b2c9\u671f\u66fe\u520a\u767b\u8fc7\u7531\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u4e13\u5bb6\u64b0\u5199\u7684\u4e00\u7bc7\u7efc\u8ff0\u300a\u53e3\u670d\u56fa\u4f53\u4eff\u5236\u5236\u5242\u8d28\u91cf\u548c\u7597\u6548\u4e00\u81f4\u6027\u8bc4\u4ef7\u8fc7\u7a0b\u4e2d\u7684\u51e0\u70b9\u601d\u8003\u300b\uff0c\u901a\u8baf\u4f5c\u8005\u5f20\u56fd\u534e\u535a\u58eb\u548c<span style=\"max-width: 100%;font-family: MicrosoftYaHei;font-size: 13px;text-indent: 28px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u9648\u4e49\u751f\u535a\u58eb\u3002\uff08\u539f\u6587\u94fe\u63a5\uff1a<\/span><\/span><a href=\"http:\/\/mp.weixin.qq.com\/s?__biz=MzA5MDY3ODExNQ==&amp;mid=2651302941&amp;idx=1&amp;sn=ddfbedc2c5df2bcfd92a92c5180be2c7&amp;chksm=8bf4fa11bc8373076d2ac6f2248c5b3756bb1c4c2795fc97c47e01c5d64bd683513469a4650f&amp;scene=21#wechat_redirect\" target=\"_blank\" style=\"color: rgb(87, 107, 149);-webkit-tap-highlight-color: rgba(0, 0, 0, 0);max-width: 100%;font-size: 14px;text-indent: 2em;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u4e13\u5bb6\u8c08\u53e3\u670d\u56fa\u4f53\u4eff\u5236\u5236\u5242\u4e00\u81f4\u6027\u8bc4\u4ef7\u8fc7\u7a0b\u4e2d\u7684\u51e0\u70b9\u601d\u8003\uff08\u72ec\u5bb6\u539f\u521b\uff09<\/a><span style=\"max-width: 100%;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\uff0c\u83b7\u5f97\u4e1a\u5185\u540c\u884c\u7684\u5e7f\u6cdb\u5173\u6ce8\u548c\u597d\u8bc4\u3002\u4eca\u65e5\u5206\u4eab\u8054\u4e9a\u56e2\u961f\u7684\u53e6\u4e00\u7bc7\u539f\u521b\u597d\u6587\uff0c\u7b2c\u4e00\u4f5c\u8005\u9f9a\u5065\u5c06\u5728\u4ee5\u4e0b\u5c0f\u89c6\u9891\u4e2d\uff0c\u75283\u5206\u949f\u65f6\u95f4\u5e26\u8bfb\u8005\u670b\u53cb\u5feb\u901f\u4e86\u89e3\u672c\u6587\u7684\u4eae\u70b9\uff0c\u611f\u8c22\u60a8\u5173\u6ce8\uff01<\/span><\/p>\n<div class=\"bp-video\">\n<div class=\"player\">\n                    <iframe class=\"bp-iframe\" width=\"100%\" src=\"https:\/\/v.qq.com\/iframe\/preview.html?&amp;&amp;auto=0&amp;vid=d0807sg45hx\" frameborder=\"0\" allowfullscreen=\"true\"><\/iframe>\n                <\/div>\n<\/div>\n<section class=\"\" style=\"padding-right: 4px;padding-left: 4px;max-width: 100%;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;border-width: 1px;border-style: dashed;border-color: rgb(255, 102, 0);background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\n<section style=\"margin-top: 5px;margin-bottom: 5px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\n<section style=\"margin: 5px auto;max-width: 100%;border-width: initial;border-style: none;border-color: initial;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span class=\"\" style=\"padding-right: 30px;padding-left: 30px;max-width: 100%;display: block;color: rgb(255, 255, 255);background: rgb(255, 129, 36);box-sizing: border-box !important;word-wrap: break-word !important;\"><\/p>\n<section class=\"\" style=\"padding-right: 10px;padding-left: 10px;max-width: 100%;height: 30px;line-height: 30px;display: inline-block;color: rgb(255, 129, 36);border-color: rgb(255, 129, 36);background: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\n<p style=\"max-width: 100%;min-height: 1em;white-space: pre-wrap;border-color: rgb(255, 129, 36);box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e13\u5bb6\u4ecb\u7ecd<\/strong><\/p>\n<\/section>\n<p><\/span><\/section>\n<\/section>\n<\/section>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><img class=\"\"       style=\"box-sizing: border-box !important;word-wrap: break-word !important;width: 162px !important;visibility: visible !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/8-1544149444.jpg\" alt=\"\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u4e13\u5bb6\u4ee5FDA\u6279\u51c6\u7684\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e3a\u4f8b\u8c08\u9ad8\u7aef\u53e3\u670d\u56fa\u4f53\u7f13\u63a7\u91ca\u5236\u5242\u5f00\u53d1\" title=\"\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u4e13\u5bb6\u4ee5FDA\u6279\u51c6\u7684\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e3a\u4f8b\u8c08\u9ad8\u7aef\u53e3\u670d\u56fa\u4f53\u7f13\u63a7\u91ca\u5236\u5242\u5f00\u53d1\"><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 13px;font-family: MicrosoftYaHei;box-sizing: border-box !important;word-wrap: break-word !important;\">\u9648\u4e49\u751f\uff1a<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: FZBSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u535a\u58eb\uff0c\u4e8e<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">1994<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: FZBSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5e74\u5728\u7f8e\u56fd\u7231\u8377\u534e\u5927\u5b66\u83b7\u5f97\u836f\u5242\u5b66\u535a\u58eb\u5b66\u4f4d\uff0c\u5e76\u83b7<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">Rho Chi<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 13px;font-family: FZBSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u534f\u4f1a\u7ec8\u751f\u4f1a\u5458\u8363\u8a89\u3002\u4e4b\u540e\u5728\u7f8e\u56fd<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">Burroughs Wellcome<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: FZBSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u516c\u53f8\u548c<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">Abbott<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: FZBSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u516c\u53f8\u4efb\u7814\u53d1\u5458\u76f4\u81f3\u90e8\u95e8\u7ecf\u7406\uff0c\u5e76\u88ab\u9009\u4e3a<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">Volwiler<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 13px;font-family: FZBSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u534f\u4f1a\u526f\u7814\u7a76\u5458\uff0c\u7f8e\u56fd\u4ea7\u54c1\u8d28\u91cf\u7814\u7a76\u6240\uff08<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">PQRI<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: FZBSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u4e13\u5bb6\uff0c\u7f8e\u56fd\u836f\u5178\u4f1a\uff08<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">USP<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: FZBSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u6027\u80fd\u6d4b\u8bd5\u7ec4\u4e13\u5bb6\u3002\u9648\u535a\u58eb\u73b0\u4e3a\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u6709\u9650\u516c\u53f8\u526f\u603b\u88c1\uff0c\u4e3b\u5bfc\u836f\u54c1\u5f00\u53d1\u5de5\u4f5c\u3002\u9648\u535a\u58eb\u5728\u56fa\u4f53\u836f\u7269\u5f00\u53d1\u9886\u57df\u6709\u7740\u4e30\u5bcc\u7684\u77e5\u8bc6\u79ef\u7d2f\u548c\u4ea7\u4e1a\u7ecf\u9a8c\uff0c\u4ece\u56fa\u4f53\u5236\u5242\u5904\u65b9\u3001\u5de5\u827a\u5f00\u53d1\u3001<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">CMC<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: FZBSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7533\u62a5\u6587\u4ef6\u3001\u4e2d\u8bd5\u653e\u5927\u5230\u5546\u4e1a\u5316\u7684\u9a8c\u8bc1\u5de5\u4f5c\u5747\u6709\u5f88\u6df1\u7684\u9020\u8be3\u3002\u5728\u4f7f\u7528<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">Wurster<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: FZBSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5305\u8863\u6280\u672f\u5bf9\u4e0d\u540c\u7c7b\u578b\u7684\u7f13\u63a7\u91ca\u5fae\u4e38\u8fdb\u884c\u4ece\u5b9e\u9a8c\u5ba4\u3001\u4e2d\u8bd5\u5230\u5546\u4e1a\u5316\u751f\u4ea7\u9636\u6bb5\u7684\u5f00\u53d1\u548c\u653e\u5927\u65b9\u9762\u6709\u4e30\u5bcc\u7684\u7ecf\u9a8c\u3002\u6210\u529f\u9886\u5bfc\u4e86\u8d85\u8fc7<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">30<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: FZBSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u79cd\u836f\u54c1\u5728\u7f8e\u3001\u6b27\u3001\u65e5\u83b7\u5f97\u6279\u51c6\uff0c\u5305\u62ec\u65b0\u836f\u548c\u9ad8\u6280\u672f\u58c1\u5792\u7684\u7f8e\u56fd\u4eff\u5236\u836f\u7533\u8bf7\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 13px;font-family: FZBSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u9648\u535a\u58eb\u5e94\u7528\u6269\u6563\u7406\u8bba\u5f00\u53d1\u7684\u4e00\u4e2a\u9884\u6d4b\u5305\u88c5\u4ea7\u54c1\u5728\u50a8\u5b58\u8fc7\u7a0b\u4e2d\u6c34\u5206\u5438\u6536\u7684\u7406\u8bba\u6a21\u578b\u5df2\u88ab\u4e1a\u754c\u5e7f\u6cdb\u5e94\u7528\u3002\u4ed6\u7684\u7406\u8bba\u6210\u4e3a<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">ASTM D7709<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: FZBSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u548c<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">USP<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: FZBSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u901a\u5219<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">&lt; 671 &gt;<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: FZBSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7ae0\u4e2d\u5173\u4e8e\u5bb9\u5668\u4e2d\u6c34\u84b8\u6c7d\u900f\u8fc7\u7387\uff08<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">WVTR<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: FZBSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u7684\u6807\u51c6\u68c0\u6d4b\u65b9\u6cd5\u7684\u5efa\u7acb\u4e0e\u4fee\u8ba2\u7684\u4f9d\u636e\u3002\u4ed6\u662f\u5236\u5242\u7814\u53d1\u6743\u5a01\u4e13\u8457\u300a<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: FZKTK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u56fa\u4f53\u53e3\u670d\u5236\u5242\u7684\u7814\u53d1\u2014\u2014\u836f\u5b66\u7406\u8bba\u4e0e\u5b9e\u8df5\u300b<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: FZBSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e00\u4e66\u7684\u7b2c\u4e8c\u4e3b\u7f16\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><img class=\"\"       style=\"box-sizing: border-box !important;word-wrap: break-word !important;width: 161px !important;visibility: visible !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/6-1544149444.jpg\" alt=\"\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u4e13\u5bb6\u4ee5FDA\u6279\u51c6\u7684\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e3a\u4f8b\u8c08\u9ad8\u7aef\u53e3\u670d\u56fa\u4f53\u7f13\u63a7\u91ca\u5236\u5242\u5f00\u53d1\" title=\"\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u4e13\u5bb6\u4ee5FDA\u6279\u51c6\u7684\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e3a\u4f8b\u8c08\u9ad8\u7aef\u53e3\u670d\u56fa\u4f53\u7f13\u63a7\u91ca\u5236\u5242\u5f00\u53d1\"><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: FZDHTK--GBK1-0;color: rgb(255, 102, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: MicrosoftYaHei;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5f20\u56fd\u534e\uff1a<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: FZBSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u535a\u58eb\uff0c\u4e8e<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">1989<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: FZBSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5e74\u5728\u7f8e\u56fd\u8d39\u57ce\u836f\u5b66\u4e0e\u79d1\u5b66\u9662\u83b7\u5f97\u836f\u5242\u5b66\u535a\u58eb\u5b66\u4f4d\u3002<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">1989<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: FZBSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5e74\u81f3<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">1991<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: FZBSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5e74\u4efb\u7f8e\u56fd\u5148\u7075\u8446\u96c5\u7814\u7a76\u6240\u535a\u58eb\u540e\u7814\u7a76\u5458\uff0c<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">1992<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: FZBSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5e74\u81f3<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2006<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: FZBSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5e74\u5148\u540e\u62c5\u4efb\u7f8e\u56fd<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">Roche<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: FZBSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u516c\u53f8\u836f\u7269\u7814\u53d1\u90e8\u8d44\u6df1\u7814\u7a76\u5458\u3001<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">Duramed<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: FZBSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff08\u76ee\u524d\u4e3a<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">TEVA<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: FZBSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u548c<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">Andrx<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: FZBSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff08\u76ee\u524d\u4e3a<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">Allergan<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: FZBSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u516c\u53f8\u526f\u603b\u88c1\u548c\u8d44\u6df1\u526f\u603b\u88c1\uff0c\u4e3b\u7ba1\u516c\u53f8\u7814\u53d1\u90e8\u95e8\u3002<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2006<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: FZBSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5e74\u56de\u56fd\u521b\u529e\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u6709\u9650\u516c\u53f8\uff0c\u62c5\u4efb\u603b\u88c1\u548c\u9996\u5e2d\u6267\u884c\u5b98\u81f3\u4eca\u3002<\/span><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 13px;font-family: FZBSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5f20\u56fd\u534e\u535a\u58eb\u4e3b\u8981\u7814\u7a76\u65b9\u5411\u4e3a\u836f\u7269\u65b0\u5242\u578b\uff0c\u5305\u62ec\u836f\u7269\u4f20\u5bfc\u7cfb\u7edf\u548c\u7f13\u63a7\u91ca\u5236\u5242\u7684\u5f00\u53d1\uff0c\u4ee5\u53ca\u4ea7\u54c1\u4ea7\u4e1a\u5316\u3002\u5728<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">28<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: FZBSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5e74\u7684\u533b\u53d1\u751f\u6daf\u4e2d\uff0c\u4e3b\u6301\u5e76\u53c2\u4e0e\u5f00\u53d1\u7684<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">160<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: FZBSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u591a\u79cd\u9ad8\u4eff\u548c\u65b0\u836f\u836f\u7269\u5236\u5242\u4ea7\u54c1\u5747\u83b7\u5f97\u7f8e\u56fd<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: FZBSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7684\u6279\u51c6\uff0c\u5168\u90e8\u4ea7\u4e1a\u5316\u5e76\u6295\u653e\u7f8e\u56fd\u5904\u65b9\u836f\u5e02\u573a\uff0c\u5176\u4e2d\u5305\u62ec\u591a\u4e2a\u53e3\u670d\u7f13\u63a7\u91ca\u5236\u5242\u548c\u9996\u4eff\u836f\u7269\u5236\u5242\u3002\u5728\u56fd\u9645\u671f\u520a\u548c\u4e13\u4e1a\u4e66\u520a\uff0c\u4ee5\u53ca\u56fd\u9645\u4f1a\u8bae\u4e0a\u64b0\u5199\u548c\u53d1\u8868\u4e86<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">50<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: FZBSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u591a\u7bc7\u8bba\u6587\u5e76\u4f5c\u6f14\u8bb2\uff0c\u62e5\u6709\u591a\u9879\u53d1\u660e\u4e13\u5229\uff0c\u8fd8\u66fe\u62c5\u4efb\u591a\u9879\u5b66\u672f\u7ec4\u7ec7\u548c\u4ea7\u4e1a\u8054\u76df\u804c\u52a1\uff0c\u5176\u4e2d\u5305\u62ec\uff1a\u7f8e\u4e2d\u533b\u836f\u5f00\u53d1\u534f\u4f1a\uff08<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">SAPA<\/span><span style=\"max-width: 100%;font-size: 13px;font-family: FZBSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u521b\u529e\u8005\u548c\u4f1a\u5458\uff08\u66fe\u4efb\u7b2c\u4e8c\u5c4a\u4e3b\u5e2d\uff09\u3001\u4e2d\u56fd\u56fd\u5bb6\u79d1\u59d4\u65b0\u7a76\u4e0e\u5f00\u53d1\u4e13\u5bb6\u6d77\u5916\u59d4\u5458\u4f1a\u59d4\u5458\u3001\u4e2d\u56fd\u56fd\u5bb6\u8ba1\u5212\u751f\u80b2\u59d4\u5458\u4f1a\u7b2c\u4e09\u5c4a\u79d1\u6280\u4e13\u5bb6\u59d4\u5458\u4f1a\u59d4\u5458\u3001\u6c5f\u82cf\u7701\u533b\u5065\u4ea7\u4e1a\u8054\u76df\u526f\u7406\u4e8b\u957f\u7b49\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><\/p>\n<section class=\"\" style=\"padding-right: 4px;padding-left: 4px;max-width: 100%;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;border-width: 1px;border-style: dashed;border-color: rgb(255, 102, 0);background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\n<section style=\"margin-top: 5px;margin-bottom: 5px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\n<section style=\"margin: 5px auto;max-width: 100%;border-width: initial;border-style: none;border-color: initial;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span class=\"\" style=\"padding-right: 30px;padding-left: 30px;max-width: 100%;display: block;color: rgb(255, 255, 255);background: rgb(255, 129, 36);box-sizing: border-box !important;word-wrap: break-word !important;\"><\/p>\n<section class=\"\" style=\"padding-right: 10px;padding-left: 10px;max-width: 100%;height: 30px;line-height: 30px;display: inline-block;color: rgb(255, 129, 36);border-color: rgb(255, 129, 36);background: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\n<p style=\"max-width: 100%;min-height: 1em;white-space: pre-wrap;border-color: rgb(255, 129, 36);box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6b63\u6587<\/strong><\/p>\n<\/section>\n<p><\/span><\/section>\n<\/section>\n<\/section>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 32px;font-family: FZDHTK--GBK1-0;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">\u9ad8\u7aef\u53e3\u670d\u56fa\u4f53\u4eff\u5236\u836f\u7684\u8bbe\u8ba1\u53ca\u5176\u4ea7\u54c1\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u7684\u63a7\u5236<\/span><span style=\"max-width: 100%;font-size: 24px;font-family: FZDHTK--GBK1-0;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">\u2014\u2014\u4ee5FDA \u6279\u51c6\u7684\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e3a\u4f8b<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: FZDHTK--GBK1-0;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">[ \u6458\u8981]<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 13px;font-family: MicrosoftYaHei;box-sizing: border-box !important;word-wrap: break-word !important;\">\u9ad8\u7aef\u5236\u5242\u96be\u4ee5\u4eff\u5236\u7684\u4e3b\u8981\u539f\u56e0\u662f\u4ea7\u54c1\u7684\u8bbe\u8ba1\u8981\u6c42\u6bd4\u8f83\u590d\u6742\uff0c\u5982\u679c\u5bf9\u4ea7\u54c1\u7684\u7406\u89e3\u548c\u63a7\u5236\u4e0d\u8db3\uff0c\u4ea7\u54c1\u8d28\u91cf\u548c\u751f\u7269\u7b49\u6548\u6027\u5219\u96be\u4ee5\u7b26\u5408\u8981\u6c42\u3002\u76ee\u524d\uff0c\u6211\u56fd\u533b\u836f\u5e02\u573a\u4e0a\u9ad8\u7aef\u5236\u5242\u7684\u53ef\u53ca\u6027\u8f83\u4f4e\u3002\u56fd\u5bb6\u9f13\u52b1\u521b\u65b0\u7684\u5927\u73af\u5883\u4e3a\u5236\u836f\u884c\u4e1a\u63d0\u9ad8\u8fd9\u7c7b\u4eff\u5236\u836f\u7684\u53ef\u53ca\u6027\u63d0\u4f9b\u4e86\u4e00\u4e2a\u597d\u673a\u4f1a\u3002\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u662f\u4e00\u4e2a\u8f83\u96be\u5f00\u53d1\u548c\u751f\u4ea7\u7684\u9ad8\u7aef\u4eff\u5236\u836f\u7269\u5236\u5242\u3002\u4ee5\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u88ab\u7f8e\u56fdFDA \u6279\u51c6\u7684\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e3a\u4f8b\uff0c\u5bf9\u6b64\u4ea7\u54c1\u7684\u5236\u5242\u7279\u70b9\u3001\u7814\u53d1\u6280\u672f\u96be\u70b9\u3001\u5ba1\u8bc4\u8981\u6c42\u53ca\u6700\u7ec8\u4ea7\u54c1\u6d4b\u8bd5\u7ed3\u679c\u8fdb\u884c\u4ecb\u7ecd\uff0c\u4ee5\u671f\u4e3a\u56fd\u5185\u9ad8\u7aef\u4eff\u5236\u836f\u7269\u5236\u5242\u7684\u5f00\u53d1\u53ca\u5ba1\u8bc4\u63d0\u4f9b\u53c2\u8003\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: FZDHTK--GBK1-0;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">[ \u5173\u952e\u8bcd]<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 13px;font-family: MicrosoftYaHei;box-sizing: border-box !important;word-wrap: break-word !important;\">\u9ad8\u7aef\u4eff\u5236\u836f\u7269\u5236\u5242\uff1b\u8d28\u91cf\u6e90\u4e8e\u8bbe\u8ba1\uff1b\u5173\u952e\u8d28\u91cf\u5c5e\u6027\uff1b\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\uff1b\u7f13\u91ca\u7247<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 13px;font-family: MicrosoftYaHei;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e2d\u56fd\u662f\u4eff\u5236\u836f\u5927\u56fd\u3002\u81ea\u4ece\u539f\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\uff08<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">CFDA<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u4e8e<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2012<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5e74\u5f00\u59cb\u63a8\u52a8\u4eff\u5236\u836f\u8d28\u91cf\u548c\u7597\u6548\u4e00\u81f4\u6027\u8bc4\u4ef7\u4ee5\u6765\uff0c\u4eff\u5236\u836f\u7684\u8d28\u91cf\u53d7\u5230\u4e86\u524d\u6240\u672a\u6709\u7684\u91cd\u89c6\u3002<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2018<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5e74<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">4<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6708<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">3<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u65e5\uff0c\u56fd\u52a1\u9662\u529e\u516c\u5385\u518d\u6b21\u5c31\u4eff\u5236\u836f\u4f9b\u5e94\u4fdd\u969c\u53ca\u4f7f\u7528\u653f\u7b56\u53d1\u5e03\u6307\u5bfc\u610f\u89c1\uff0c\u65e8\u5728\u8981\u6c42\u5404\u7ea7\u673a\u6784\u8981\u5728\u91c7\u8d2d\u3001\u533b\u4fdd\u3001\u7a0e\u6536\u3001\u5ba3\u4f20\u7b49\u65b9\u9762\u5168\u9762\u7ed9\u4e88\u4e0e\u539f\u7814\u836f\u8d28\u91cf\u548c\u7597\u6548\u4e00\u81f4\u7684\u4eff\u5236\u836f\u4ee5\u652f\u6301\uff0c\u5927\u529b\u63d0\u9ad8\u836f\u54c1\u7684\u53ef\u53ca\u6027\u548c\u4f9b\u5e94\u4fdd\u969c\u80fd\u529b\uff0c\u6700\u7ec8\u5b9e\u73b0\u4eff\u5236\u836f\u5bf9\u4e8e\u539f\u7814\u836f\u7684\u66ff\u4ee3\u4f7f\u7528\u3002\u5728\u56fd\u5bb6\u5173\u4e8e\u4eff\u5236\u836f\u51fa\u53f0\u4e00\u7cfb\u5217\u5229\u597d\u653f\u7b56\u7684\u63a8\u52a8\u4e0b\uff0c\u968f\u7740\u6211\u56fd\u5236\u836f\u5de5\u4e1a\u6c34\u5e73\u7684\u4e0d\u65ad\u63d0\u5347\uff0c\u4eff\u5236\u836f\u7684\u8d28\u91cf\u548c\u7597\u6548\u5c06\u6709\u8d28\u7684\u98de\u8dc3\uff0c\u6211\u56fd\u4f1a\u7531\u4eff\u5236\u5927\u56fd\u6210\u957f\u4e3a\u4eff\u5236\u5f3a\u56fd\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4eff\u5236\u836f\u6709\u7b80\u5355\u7684\uff0c\u4e5f\u6709\u590d\u6742\u7684\u3001\u96be\u4ee5\u4eff\u5236\u548c\u751f\u4ea7\u7684\uff0c\u540e\u8005\u53ef\u4ee5\u79f0\u4e4b\u4e3a\u9ad8\u7aef\u4eff\u5236\u836f\u3002\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u5c06\u590d\u6742\u4eff\u5236\u836f\u5206\u4e3a\u4ee5\u4e0b\u51e0\u7c7b\uff1a<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">1<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u590d\u6742\u6d3b\u6027\u6210\u5206\u7c7b\uff1b<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u590d\u6742\u5904\u65b9\u548c\u5242\u578b\u7c7b\uff1b<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">3<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u590d\u6742\u9012\u836f\u9014\u5f84\u7c7b\uff1b<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">4<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u590d\u6742\u7ec4\u5408\u836f\u7269<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">&#8211;<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5668\u5177\u7c7b\u3002\u5bf9\u4e8e\u53e3\u670d\u56fa\u4f53\u4eff\u5236\u836f\u6765\u8bb2\uff0c\u4e00\u4e9b\u65e8\u5728\u63d0\u9ad8\u96be\u6eb6\u6027\u836f\u7269\u751f\u7269\u5229\u7528\u5ea6\u7684\u4eff\u5236\u836f\u3001\u7f13\u63a7\u91ca\u4eff\u5236\u836f\u548c\u5de5\u827a\u590d\u6742\u7684\u4eff\u5236\u836f\u4e5f\u53ef\u5f52\u5c5e\u4e3a\u9ad8\u7aef\u4eff\u5236\u836f\u3002\u8fd9\u4e9b\u836f\u4e4b\u6240\u4ee5\u96be\u4ee5\u4eff\u5236\u662f\u56e0\u4e3a\u5b83\u4eec\u9700\u8981\u7528\u4e00\u4e9b\u6bd4\u8f83\u590d\u6742\u7684\u5904\u65b9\u548c\u5de5\u827a\u6765\u6ee1\u8db3\u4ea7\u54c1\u7684\u5173\u952e\u8d28\u91cf\u5c5e\u6027\uff08<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">criticalquality attributes<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff0c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">CQAs<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u8981\u6c42\u3002\u6bcf\u4e2a\u4ea7\u54c1\u7684<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">CQAs<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e0d\u4e00\u5b9a\u76f8\u540c\uff0c\u63a7\u5236\u7684\u65b9\u6cd5\u4e5f\u8981\u6839\u636e\u5177\u4f53\u4ea7\u54c1\u8fdb\u884c\u5177\u4f53\u5206\u6790\u3002\u4f8b\u5982\uff0c\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u662f\u7531\u7f13\u91ca\u5305\u8863\u5fae\u4e38\u5916\u52a0\u5176\u4ed6\u8f85\u6599\u6df7\u5408\u540e\u538b\u7247\u800c\u6210\u3002\u7531\u4e8e\u5fae\u4e38\u4e0e\u8f85\u6599\u96be\u4ee5\u6df7\u5408\u5747\u5300\uff0c\u5fae\u4e38\u7684\u5305\u8863\u819c\u5bb9\u6613\u88ab\u538b\u788e\uff0c\u56e0\u6b64\u4ea7\u54c1\u542b\u91cf\u5747\u5300\u5ea6\u5305\u62ec\u6df7\u5408\u5747\u5300\u5ea6\uff08<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">blend uniformity<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff0c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">BU<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u548c\u7247\u5242\u542b\u91cf\u5747\u5300\u5ea6\uff08<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">content uniformity<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff0c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">CU<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\uff0c\u4ee5\u53ca\u4ea7\u54c1\u6eb6\u51fa\u5ea6\u90fd\u6bd4\u8f83\u96be\u4ee5\u63a7\u5236\u800c\u5b58\u5728\u8f83\u9ad8\u7684\u4ea7\u54c1\u8d28\u91cf\u9690\u60a3\u3002\u9664\u4e86\u5fc5\u987b\u6ee1\u8db3\u7684\u751f\u7269\u7b49\u6548\u6027\uff08<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">bioequivalence<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff0c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">BE<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u4e4b\u5916\uff0c\u8be5\u4ea7\u54c1\u7684<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">CQAs<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5305\u62ec\u4ea7\u54c1\u7684<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">BU<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3001<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">CU<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u548c\u6eb6\u51fa\u5ea6\u3002\u6b64\u5916\uff0c\u7531\u4e8e\u6b64\u4ea7\u54c1\u4e3a\u53ef\u63b0\u5206\u7247\uff0c\u56e0\u6b64\u836f\u7247\u7684\u63b0\u5206\u6027\u4e5f\u662f\u6b64\u4ea7\u54c1\u9700\u8981\u8003\u5bdf\u7684\u53e6\u4e00\u5173\u952e\u5c5e\u6027\u3002\u9488\u5bf9\u8fd9\u4e9b\u5177\u4f53\u7684\u95ee\u9898\uff0c\u5728\u4ea7\u54c1\u5f00\u53d1\u8fc7\u7a0b\u4e2d\uff0c\u5fc5\u987b\u901a\u8fc7\u5408\u7406\u7684\u8bbe\u8ba1\u548c\u63a7\u5236\u6765\u6d88\u9664\u8be5\u4ea7\u54c1\u7684\u8d28\u91cf\u9690\u60a3\u3002\u5982\u679c\u5bf9\u4ea7\u54c1\u7684\u7279\u70b9\u6ca1\u6709\u8db3\u591f\u7684\u7406\u89e3\u548c\u63a7\u5236\uff0c\u4ea7\u54c1\u8d28\u91cf\u548c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">BE<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5219\u96be\u4ee5\u7b26\u5408\u8981\u6c42\u3002\u56e0\u6b64\uff0c\u9ad8\u7aef\u4eff\u5236\u836f\u7684\u5173\u952e\u70b9\u662f\u5728\u590d\u6742\u7684\u5904\u65b9\u548c\u751f\u4ea7\u5de5\u827a\u4e0b\u5982\u4f55\u786e\u4fdd\u4eff\u5236\u836f\u4e0e\u539f\u7814\u836f\u4e4b\u95f4\u5b9e\u73b0\u53ef\u9760\u7684\u836f\u5b66\u7b49\u6548\u3001\u751f\u7269\u7b49\u6548\u3001\u4ee5\u53ca\u4fdd\u6301\u957f\u671f\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u7684\u8d28\u91cf\u5e73\u7a33\u6027\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u7684\u539f\u7814\u836f\u4e8e<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">1992<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5e74\u83b7\u5f97\u7f8e\u56fd<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6279\u51c6\u3002\u622a\u81f3<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2017<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5e74\u5e95\uff0c\u9664\u539f\u7814\u5236\u5242\u5916\uff0c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5df2\u6279\u51c6\u6b64\u4ea7\u54c1\u7684<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">8<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e2a\u4eff\u5236\u5236\u5242\uff0c\u5c3d\u7ba1\u76ee\u524d\u8be5\u54c1\u79cd\u7684\u5e02\u573a\u9700\u6c42\u5f88\u5927\uff0c\u4f46\u7531\u4e8e\u591a\u79cd\u539f\u56e0\uff0c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2017<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5e74\u7f8e\u56fd\u5e02\u573a\u5bf9\u8be5\u4ea7\u54c1\u7684\u4f9b\u5e94\u4ec5\u6765\u81ea\u4e8e\u539f\u7814\u516c\u53f8\u548c\u4ec5\u5269\u7684<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5bb6\u4eff\u5236\u836f\u516c\u53f8\uff0c\u4e2d\u56fd\u5e02\u573a\u65b9\u9762\uff0c\u539f\u7814\u836f\u4e00\u76f4\u5904\u4e8e\u5784\u65ad\u5730\u4f4d\uff0c\u56e0\u6b64\u8be5\u4ea7\u54c1\u88ab\u516c\u8ba4\u4e3a\u6280\u672f\u542b\u91cf\u8f83\u9ad8\u7684\u9ad8\u7aef\u5236\u5242\u4e4b\u4e00\u3002\u672c\u6587\u4ee5\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u83b7<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6279\u51c6\u7684\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e3a\u4f8b\uff0c\u5bf9\u6b64\u4ea7\u54c1\u7684\u5236\u5242\u7279\u70b9\u3001\u7814\u53d1\u6280\u672f\u96be\u70b9\u3001\u5ba1\u8bc4\u8981\u6c42\u53ca\u6700\u7ec8\u4ea7\u54c1\u6d4b\u8bd5\u7ed3\u679c\u8fdb\u884c\u4ecb\u7ecd\uff0c\u4ee5\u671f\u4e3a\u56fd\u5185\u9ad8\u7aef\u4eff\u5236\u836f\u7269\u5236\u5242\u7684\u5f00\u53d1\u53ca\u5ba1\u8bc4\u63d0\u4f9b\u53c2\u8003\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 21px;font-family: FZDHTK--GBK1-0;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">1 \u836f\u7269\u5236\u5242\u4ecb\u7ecd<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7f8e\u6258\u6d1b\u5c14\u662f\u4e00\u79cd\u9009\u62e9\u6027<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">\u03b2<\/span><span style=\"max-width: 100%;font-size: 10px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">1<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u53d7\u4f53\u963b\u6ede\u5242\uff0c\u5df2\u88ab\u5217\u4e3a\u8bc1\u636e\u660e\u786e\u3001\u53ef\u6539\u5584\u9884\u540e\u7684\u4e94\u5927\u7c7b\u964d\u538b\u836f\u7269\u4e4b\u4e00\uff0c\u540c\u65f6\u4e5f\u662f\u6cbb\u7597\u5fc3\u7ede\u75db\u548c\u6162\u6027\u5fc3\u529b\u8870\u7aed\u7684\u4e00\u7ebf\u7528\u836f\u3002\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u7684\u539f\u7814\u836f\u4e3a\u963f\u65af\u5229\u5eb7\u516c\u53f8\u5f00\u53d1\u7684\u6bcf\u65e5<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">1<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6b21\u7f13\u91ca\u5236\u5242\uff0c\u4e8e<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">1992<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5e74\u83b7\u5f97\u7f8e\u56fd<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6279\u51c6\uff0c\u5171\u6709<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">23.75mg<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3001<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">47.5 mg<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3001<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">95 mg<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u548c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">190 mg 4<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e2a\u89c4\u683c\uff0c\u5546\u54c1\u540d\u4e3a<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">Toprol-XL<\/span><span style=\"max-width: 100%;font-size: 10px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">\u00ae<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3002\u8be5\u4ea7\u54c1\u4e8e<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2005<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5e74\u8fdb\u5165\u4e2d\u56fd\u5e02\u573a\uff0c\u5546\u54c1\u540d\u4e3a\u500d\u4ed6\u4e50\u514b\u3002\u76ee\u524d\uff0c\u56fd\u5185\u5df2\u6709\u9152\u77f3\u9178\u7f8e\u6258\u6d1b\u5c14\u666e\u901a\u5236\u5242\u3001\u7f13\u63a7\u91ca\u7247\u3001\u6ce8\u5c04\u5242\u83b7\u6279\uff0c\u4f46\u6ca1\u6709\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u63a7\u91ca\u7247\u83b7\u6279\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u91c7\u7528\u5fae\u4e38\u8584\u819c\u5305\u8863\u6280\u672f\u63a7\u5236\u9012\u836f\u901f\u5ea6\u4ee5\u5ef6\u957f\u836f\u7269\u7684\u7597\u6548\uff0c\u5176\u7efc\u5408\u4e86\u591a\u5355\u5143\u5236\u5242\u4ee5\u53ca\u53ef\u7cbe\u51c6\u63b0\u5206\u7f13\u63a7\u91ca\u7247\u7684\u4f18\u70b9\u3002\u8be5\u5236\u5242\u7531\u5f88\u591a\u542b\u6d3b\u6027\u6210\u5206\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7684\u819c\u63a7\u578b\u5305\u8863\u7f13\u91ca\u5fae\u4e38\u7ec4\u6210\uff0c\u6bcf\u4e2a\u5fae\u4e38\u662f\u4e00\u4e2a\u72ec\u7acb\u63a7\u5236\u7684\u9012\u836f\u5355\u5143\uff08\u89c1\u56fe<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">1<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u3002\u53e3\u670d\u540e\u836f\u7247\u63a5\u89e6\u80c3\u5185\u6db2\u4f53\u540e\u5feb\u901f\u5d29\u89e3\u91ca\u653e\u51fa\u5fae\u4e38\uff0c\u5fae\u4e38\u5206\u6563\u540e\u7f13\u6162\u91ca\u653e\u836f\u7269\u3002\u4e0e\u4e00\u822c\u9aa8\u67b6\u578b\u7f13\u63a7\u91ca\u5236\u5242\u76f8\u6bd4\uff0c\u4ee5\u819c\u63a7\u578b\u5305\u8863\u5fae\u4e38\u4e3a\u57fa\u7840\u7684\u5d29\u89e3\u578b\u7f13\u91ca\u7247\u5177\u6709\u591a\u5355\u5143\u5236\u5242\u7684\u8bf8\u591a\u4f18\u70b9\uff0c\u5982\u53e3\u670d\u540e\u9012\u836f\u5355\u5143\u5728\u80c3\u80a0\u9053\u5747\u5300\u5206\u6563\uff0c\u53ef\u907f\u514d\u5c40\u90e8\u836f\u7269\u6d53\u5ea6\u8fc7\u9ad8\u5f15\u8d77\u7684\u80c3\u80a0\u9053\u9ecf\u819c\u523a\u6fc0\uff1b\u76f8\u5bf9\u4e00\u81f4\u7684\u80c3\u6392\u7a7a\uff0c\u53ef\u51cf\u5c11\u4e2a\u4f53\u5dee\u5f02\uff1b\u4e2a\u522b\u5355\u5143\uff08\u5fae\u4e38\uff09\u5305\u8863\u7684\u7f3a\u9677\u4e0d\u4f1a\u5bfc\u81f4\u6574\u4f53\u5236\u5242\u91ca\u836f\u884c\u4e3a\u7684\u6539\u53d8\u3002\u56e0\u6b64\uff0c\u8bbe\u8ba1\u5408\u7406\u7684\u4ee5\u5305\u8863\u5fae\u4e38\u4e3a\u57fa\u7840\u7684\u7f13\u91ca\u7247\u80fd\u5b9e\u73b0\u6eb6\u51fa\u5ea6\u4ee5\u53ca\u836f\u6548\u7684\u6279\u95f4\u9ad8\u5ea6\u4e00\u81f4\u6027\u3002\u540c\u65f6\uff0c\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e3a\u6709\u523b\u75d5\u53ef\u63b0\u5206\u7247\uff0c\u6709\u5229\u4e8e\u4e34\u5e8a\u7528\u836f\u7684\u5242\u91cf\u7075\u6d3b\u6027\u3002\u4f46\u8fd9\u79cd\u5236\u5242\u8d28\u91cf\u8981\u6c42\u9ad8\uff0c\u8bbe\u8ba1\u96be\u5ea6\u5927\uff0c\u5bf9\u751f\u4ea7\u6280\u672f\u8981\u6c42\u975e\u5e38\u9ad8\uff0c\u975e\u5e38\u96be\u4ee5\u4eff\u5236\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;text-align: center;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><img class=\"\"       style=\"box-sizing: border-box !important;word-wrap: break-word !important;width: 479px !important;visibility: visible !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/4-1544149444.png\" alt=\"\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u4e13\u5bb6\u4ee5FDA\u6279\u51c6\u7684\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e3a\u4f8b\u8c08\u9ad8\u7aef\u53e3\u670d\u56fa\u4f53\u7f13\u63a7\u91ca\u5236\u5242\u5f00\u53d1\" title=\"\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u4e13\u5bb6\u4ee5FDA\u6279\u51c6\u7684\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e3a\u4f8b\u8c08\u9ad8\u7aef\u53e3\u670d\u56fa\u4f53\u7f13\u63a7\u91ca\u5236\u5242\u5f00\u53d1\"><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 21px;font-family: FZDHTK--GBK1-0;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">2 \u5236\u5242\u73b0\u72b6<\/span><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u539f\u7814\u836f\u7684\u4e13\u5229\u5df2\u4e8e<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2011<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5e74\u8fc7\u671f\uff0c\u4f46\u56e0\u5176\u590d\u6742\u7684\u6280\u672f\u548c\u751f\u4ea7\u5de5\u827a\u4f7f\u4eff\u5236\u836f\u7684<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e2a\u4e00\u81f4\u6027\u7684\u5b9e\u73b0\u589e\u52a0\u4e86\u96be\u5ea6\uff0c\u5373\uff1a\u4e0e\u539f\u7814\u836f\u8d28\u91cf\u548c\u7597\u6548\u4e00\u81f4\u6027\uff0c\u4ee5\u53ca\u957f\u671f\u5546\u4e1a\u5316\u751f\u4ea7\u6279\u6b21\u4e0e<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">BE<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6279\u6b21\u95f4\u8d28\u91cf\u4e00\u81f4\u6027\uff0c\u56e0\u6b64\u5f00\u53d1\u4e0e\u751f\u4ea7\u8be5\u4eff\u5236\u5236\u5242\u7684\u96be\u5ea6\u5f88\u5927\u3002\u516c\u5f00\u7684\u4fe1\u606f\u663e\u793a\uff0c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2017<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5e74\u4e4b\u524d<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5148\u540e\u6279\u51c6\u4e86<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">8<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5bb6\u516c\u53f8\u8be5\u4ea7\u54c1\u7684\u4eff\u5236\u836f\uff0c\u4f46\u662f\u5176\u4e2d\u6709<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">5<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5bb6\u516c\u53f8\u7684\u4ea7\u54c1\u90fd\u66fe\u7ecf\u51fa\u73b0\u8fc7\u56e0\u8d28\u91cf\u95ee\u9898\uff0c\u5305\u62ec\u6eb6\u51fa\u5ea6\u95ee\u9898\u3001\u5747\u5300\u5ea6\u95ee\u9898\u53ca\u5176\u4ed6\u539f\u56e0\uff0c\u8fdb\u800c\u5f15\u8d77\u4ea7\u54c1\u53ec\u56de\u751a\u81f3\u4ea7\u54c1\u64a4\u5e02\uff0c\u5bfc\u81f4\u4e25\u91cd\u7684\u5e02\u573a\u77ed\u7f3a\u3002\u76ee\u524d\uff0c\u8be5\u54c1\u79cd\u7684\u5e02\u573a\u9700\u6c42\u91cf\u4ecd\u7136\u5f88\u5927\u3002\u6839\u636e\u5e02\u573a\u8c03\u67e5\uff0c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2017<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5e74\u7f8e\u56fd\u5e02\u573a\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u7684\u9500\u552e\u989d\u4e3a<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">7<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4ebf\u591a\u7f8e\u5143\uff0c\u7136\u800c\u4ea7\u54c1\u4f9b\u5e94\u4ec5\u6765\u81ea\u4e8e\u539f\u7814\u836f\u5f00\u53d1\u5546\u963f\u65af\u5229\u5eb7\u516c\u53f8\u548c\u5176\u59d4\u6258\u9500\u552e\u7684\u516c\u53f8\u4ee5\u53ca<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6279\u51c6\u7684\u4ec5\u5269\u7684<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5bb6\u4eff\u5236\u836f\u516c\u53f8\uff08<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">Actavis<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u548c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">Dr. Reddy<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u3002\u76ee\u524d\u5728\u4e2d\u56fd\u5e02\u573a\u65b9\u9762\uff0c\u8fdb\u53e3\u4ea7\u54c1\u500d\u4ed6\u4e50\u514b\u4ecd\u65e7\u5904\u4e8e\u5784\u65ad\u5730\u4f4d\uff0c\u65e0\u4eff\u5236\u836f\u7684\u7ade\u4e89\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 21px;font-family: FZDHTK--GBK1-0;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">3 \u6280\u672f\u96be\u70b9<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZDHTK--GBK1-0;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">3.1 \u5236\u5242\u6280\u672f\u7684\u9009\u62e9<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u524d\u6587\u5df2\u7ecf\u63d0\u5230\uff0c\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u7684\u53c2\u6bd4\u5236\u5242\u662f\u542b\u7f13\u91ca\u5fae\u4e38\u7684\u53ef\u63b0\u5206\u578b\u7f13\u91ca\u7247\uff0c\u4e5f\u5c31\u662f\u8bf4\u672c\u4ea7\u54c1\u7684\u4eff\u5236\u836f\u5fc5\u987b\u662f\u53ef\u63b0\u5206\u578b\u7f13\u91ca\u7247\u3002\u7531\u4e8e\u5fc5\u987b\u6ee1\u8db3<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e2a\u8d28\u91cf\u4e00\u81f4\u6027\u7684\u8981\u6c42\u4ee5\u53ca<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5173\u4e8e\u63b0\u5206\u7247\u7684\u8d28\u91cf\u8981\u6c42\uff0c\u7279\u522b\u662f\u8981\u6c42\u63b0\u5206\u540e\u7684\u6eb6\u51fa\u5ea6\u5fc5\u987b\u4e0e\u6574\u7247\u6eb6\u51fa\u5ea6\u4e00\u81f4\uff0c\u56e0\u6b64\u4f7f\u7528\u76f8\u540c\u7684\u5fae\u4e38\u538b\u7247\u6280\u672f\u53ef\u76f8\u5bf9\u964d\u4f4e\u4ea7\u54c1\u5f00\u53d1\u96be\u5ea6\u3002\u5176\u4ed6\u6280\u672f\u5982\u6e17\u900f\u6cf5\u6216\u9aa8\u67b6\u7247\u6280\u672f\u56e0\u63b0\u5206\u5f88\u5927\u7a0b\u5ea6\u4f1a\u5f71\u54cd\u6eb6\u51fa\u5ea6\uff0c\u4ece\u800c\u96be\u4ee5\u88ab\u7528\u4e8e\u672c\u54c1\u4eff\u5236\u836f\u7269\u5236\u5242\u7684\u5f00\u53d1\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZDHTK--GBK1-0;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">3.2 \u4ea7\u54c1\u5747\u5300\u6027<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7f13\u91ca\u5fae\u4e38\u538b\u7247\u524d\u9700\u52a0\u5165\u5176\u4ed6\u8f85\u6599\u4ee5\u4fdd\u62a4\u5fae\u4e38\u5728\u538b\u7247\u8fc7\u7a0b\u4e2d\u7684\u5b8c\u6574\u6027\u3002\u7531\u4e8e\u7f13\u91ca\u5305\u8863\u5fae\u4e38\u4e0e\u5176\u4f59\u5916\u52a0\u7269\u6599\u6027\u72b6\u7684\u5dee\u5f02\uff0c\u5982\u7c92\u5f84\u548c\u5bc6\u5ea6\u7684\u5dee\u5f02\uff0c\u8fdb\u800c\u5bfc\u81f4\u6d41\u52a8\u6027\u7684\u5dee\u5f02\uff0c\u56e0\u6b64\u5728\u6df7\u5408\u548c\u538b\u7247\u8fc7\u7a0b\u4e2d\u6781\u6613\u4ea7\u751f\u4e0d\u5747\u5300\u6216\u7c89\u672b\u5206\u79bb\u73b0\u8c61\u3002\u6df7\u5408\u5668\u5185\u662f\u5426\u6709\u5bfc\u6d41\u677f\u6216\u6405\u62cc\u5668\u4f1a\u5bf9\u6df7\u5408\u5747\u5300\u5ea6\u6709\u5f71\u54cd\u3002\u6df7\u5408\u65f6\u95f4\u592a\u957f\u6216\u592a\u6fc0\u70c8\u3001\u538b\u7247\u8fc7\u7a0b\u52a0\u6599\u5668\u6405\u62cc\u901f\u5ea6\u8f83\u5feb\u5747\u6709\u53ef\u80fd\u4ea7\u751f\u9759\u7535\uff0c\u4ece\u800c\u5f15\u8d77\u7269\u6599\u7684\u9009\u62e9\u6027\u805a\u96c6\uff0c\u53cd\u800c\u5f71\u54cd\u5747\u5300\u5ea6\u3002\u6df7\u5408\u540e\u7684\u7269\u6599\u8f6c\u79fb\u6216\u538b\u7247\u8fc7\u7a0b\u7684\u632f\u52a8\uff0c\u751a\u81f3\u662f\u7ec8\u6df7\u7269\u538b\u7247\u524d\u653e\u7f6e\u8fc7\u7a0b\u4e2d\u56e0\u5fae\u4e38\u7684\u6e17\u6ee4\u4e0b\u6c89\u4f5c\u7528\u7b49\u56e0\u7d20\u5747\u53ef\u80fd\u4ea7\u751f\u7c89\u672b\u5206\u79bb\u73b0\u8c61\uff0c\u5bfc\u81f4\u538b\u7247\u4e0d\u5747\u5300\uff0c\u96be\u4ee5\u6ee1\u8db3<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">BU<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u548c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">CU<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7684\u8981\u6c42\u3002\u7406\u8bba\u4e0a\u5916\u52a0\u7269\u6599\u7684\u7c92\u5f84\u3001\u5bc6\u5ea6\u3001\u8868\u9762\u5149\u6d01\u5ea6\u548c\u8868\u9762\u80fd\u90fd\u5e94\u8be5\u4e0e\u542b\u6d3b\u6027\u836f\u7269\u7684\u7f13\u91ca\u5fae\u4e38\u4e00\u81f4\uff0c\u800c\u4e14\u5e94\u8be5\u6709\u5408\u9002\u7684\u7528\u91cf\u624d\u4e0d\u4f1a\u51fa\u73b0\u5206\u79bb\u73b0\u8c61\uff0c\u8fdb\u800c\u4fdd\u8bc1\u4ea7\u54c1\u5747\u5300\u3002<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">Teva<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u516c\u53f8\u516c\u5f00\u4e86\u4e00\u79cd\u4ee5\u7f13\u91ca\u5305\u8863\u5fae\u4e38\u4e3a\u57fa\u7840\u7684\u53ef\u76f4\u538b\u578b\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e13\u5229\uff0c\u4e13\u5229\u53f7\u4e3a<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">EP1842534B1<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff0c\u4e2d\u56fd\u540c\u65cf\u4e13\u5229\u53f7\u4e3a<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">CN101516356A<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff0c\u8be5\u4e13\u5229\u8981\u6c42\u4f18\u9009<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">80%<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7684\u5916\u52a0\u8f85\u6599\u7c92\u5f84\u6700\u597d\u5728<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">100 ~ 300 \u03bcm<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff0c\u540c\u65f6\u4f18\u9009\u7f13\u91ca\u5305\u8863\u5fae\u4e38\u5360\u6700\u7ec8\u6df7\u5408\u7269\u8d28\u91cf\u767e\u5206\u6570\u6700\u597d\u5728<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">35% ~ 45%<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3002\u9700\u8981\u6ce8\u610f\u7684\u662f\u4e0d\u540c\u5382\u5bb6\u7684\u5904\u65b9\u548c\u7269\u6599\u7684\u6027\u72b6\u53ef\u80fd\u4e0d\u4e00\u6837\uff0c\u56e0\u6b64\u6587\u732e\u4e0a\u7684\u8fd9\u4e9b\u6570\u636e\u4ec5\u4f9b\u53c2\u8003\u3002\u53e6\u5916\uff0c\u5982\u679c\u5904\u65b9\u4e2d\u7f13\u91ca\u5305\u8863\u5fae\u4e38\u6bd4\u4f8b\u592a\u4f4e\u7684\u8bdd\uff0c\u836f\u7247\u7684\u5927\u5c0f\u4e0e\u539f\u7814\u836f\u76f8\u6bd4\u53ef\u80fd\u4f1a\u8d85\u8fc7<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5173\u4e8e\u4eff\u5236\u836f\u7684\u5927\u5c0f\u3001\u5f62\u72b6\u7b49\u8981\u6c42\u3002\u9009\u62e9\u5408\u9002\u7684\u5916\u52a0\u7269\u6599\u3001\u5408\u9002\u7684\u6df7\u5408\u5668\u3001\u538b\u7247\u673a\uff0c\u51cf\u5c11\u7ec8\u6df7\u7269\u653e\u7f6e\u65f6\u95f4\u548c\u9707\u52a8\u90fd\u6709\u5229\u4e8e\u4fdd\u8bc1\u4ea7\u54c1\u7684\u5747\u5300\u5ea6\u3002\u56e0\u6b64\uff0c\u53ea\u6709\u5bf9\u5904\u65b9\u3001\u5de5\u827a\u3001\u8bbe\u5907\u7b49\u65b9\u9762\u5b9e\u884c\u4e25\u683c\u63a7\u5236\u624d\u80fd\u4fdd\u8bc1\u4ea7\u54c1\u8d28\u91cf\u7b26\u5408\u8981\u6c42\u3002\u6709\u6587\u732e\u62a5\u9053\uff0c\u90e8\u5206\u5e02\u552e\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">CU<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7684\u76f8\u5bf9\u6807\u51c6\u504f\u5dee\uff08<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">RSD<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u9ad8\u8fbe<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">5.8%<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff0c\u63a5\u53d7\u503c\uff08<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">AV<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u9ad8\u8fbe<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">14.2<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff0c\u6ee1\u8db3\u73b0\u6709\u7f8e\u56fd\u836f\u5178\uff08<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">USP<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">&lt;905&gt;<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5173\u4e8e\u4ea7\u54c1\u5747\u5300\u5ea6\u8981\u6c42\u7684\u6982\u7387\u548c\u7f6e\u4fe1\u5ea6\u90fd\u6bd4\u8f83\u4f4e\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZDHTK--GBK1-0;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">3.3 \u53ef\u63b0\u5206\u6027<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e3a\u4e86\u771f\u6b63\u5b9e\u73b0\u63b0\u5206\u7247\u7684\u5242\u91cf\u7cbe\u51c6\u6027\u4ee5\u53ca\u5728\u4e34\u5e8a\u4f7f\u7528\u4e2d\u7684\u5242\u91cf\u7075\u6d3b\u6027\uff0c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e8e<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2013<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5e74<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">3<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6708\u53d1\u5e03\u4e86\u5173\u4e8e\u53ef\u63b0\u5206\u5236\u5242\u5f00\u53d1\u7684\u6307\u5bfc\u539f\u5219\uff0c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e0d\u63a5\u53d7\u523b\u75d5\u4e0e\u53c2\u6bd4\u836f\u4e0d\u4e00\u81f4\u6216\u4e0d\u7b26\u5408\u76f8\u5173\u8981\u6c42\u7684\u4eff\u5236\u836f\u7269\u5236\u5242\u3002<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6307\u5357\u8981\u6c42\u5206\u522b\u7528\u624b\u5de5\u548c\u5668\u68b0\u63b0\u5206\u540e\u6d4b\u8bd5\uff0c\u63b0\u5206\u540e\u7684\u8d28\u91cf\u635f\u5931\u5c0f\u4e8e<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">3.0%<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff0c\u5206\u5272\u7247\u6bb5\u7684\u8106\u788e\u5ea6\u4e0d\u5927\u4e8e<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">1.0%<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff0c\u5206\u5272\u7247\u6bb5<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">CU<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7b26\u5408<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">USP&lt;905&gt;<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8981\u6c42\uff0c\u5206\u5272\u7247\u6bb5\u6eb6\u51fa\u5ea6\u548c\u5b8c\u6574\u7247\u76f8\u4f3c\uff08\u5206\u522b\u6d4b\u8bd5\u786c\u5ea6\u4e0a\u3001\u4e0b\u9650\u7684\u836f\u7247\uff09\uff0c\u5206\u5272\u7247\u6bb5\u9700\u8981\u5728\u533b\u7528\u50a8\u836f\u76d2<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">\/<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u74f6\u4e2d\u81f3\u5c11<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">3<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e2a\u6708\u4fdd\u6301\u7a33\u5b9a\u7b49\u3002\u6709\u6587\u732e\u62a5\u9053\uff0c\u76ee\u524d\u591a\u4e2a\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e0a\u5e02\u5236\u5242\u63b0\u5206\u540e\u7247\u91cd\u5747\u5300\u6027\u548c\u542b\u91cf\u5747\u5300\u6027\u90fd\u6bd4\u8f83\u5dee\uff0c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">AV<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u503c\u751a\u81f3\u9ad8\u8fbe<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">42.7<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff08<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">USP&lt;905&gt;<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8981\u6c42\u4e3a\u4e0d\u5927\u4e8e<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">15.0<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\uff0c\u4e0e<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u73b0\u6709\u8981\u6c42\u76f8\u5dee\u751a\u8fdc\u3002\u56e0\u6b64\uff0c\u5728\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4eff\u5236\u5236\u5242\u7814\u53d1\u8fc7\u7a0b\u4e2d\uff0c\u53ef\u63b0\u5206\u6027\u7684\u8bc4\u4f30\u662f\u672c\u54c1\u5f00\u53d1\u7684\u53e6\u4e00\u5927\u6311\u6218\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZDHTK--GBK1-0;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">3.4 \u7f13\u91ca\u5fae\u4e38\u4e0e\u7f13\u91ca\u7247\u7684\u6eb6\u51fa\u4e00\u81f4\u6027<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7f13\u91ca\u5fae\u4e38\u538b\u7247\u5e94\u5c3d\u53ef\u80fd\u4fdd\u6301\u538b\u7247\u524d\u540e\u6eb6\u51fa\u5ea6\u4e00\u81f4\uff0c\u800c\u4e14\u5728\u4e00\u5b9a\u8303\u56f4\u5185\u538b\u529b\u5927\u5c0f\u4e0d\u5e94\u8be5\u5f71\u54cd\u6eb6\u51fa\u5ea6\uff0c\u5426\u5219\u7531\u4e8e\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u5b58\u5728\u4e0d\u53ef\u907f\u514d\u7684\u6279\u95f4\u5dee\u5f02\uff08<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">lot-to-lotvariation<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u95ee\u9898\u548c\u96be\u4ee5\u7cbe\u51c6\u63a7\u5236\u538b\u529b\u7684\u95ee\u9898\uff0c\u6709\u5f88\u5927\u53ef\u80fd\u6027\u4f1a\u5bfc\u81f4\u4ea7\u54c1\u5728\u957f\u671f\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u8d28\u91cf\u96be\u4ee5\u63a7\u5236\u3002\u7136\u800c\uff0c\u538b\u7247\u8fc7\u7a0b\u6781\u6613\u9020\u6210\u7f13\u91ca\u5fae\u4e38\u5305\u8863\u5c42\u7684\u7834\u574f\uff0c\u4ece\u800c\u5bfc\u81f4\u7247\u5242\u7684\u6eb6\u51fa\u5ea6\u4e0e\u7f13\u91ca\u5fae\u4e38\u7684\u6eb6\u51fa\u5ea6\u4e0d\u4e00\u81f4\u3002\u76ee\u524d\uff0c\u6709\u51e0\u5bb6\u516c\u53f8\u7684\u4ea7\u54c1\u5c31\u662f\u56e0\u4e3a\u6eb6\u51fa\u5ea6\u7684\u539f\u56e0\u800c\u5bfc\u81f4\u53ec\u56de\u3002\u56e0\u6b64\u5982\u4f55\u4fdd\u6301\u539f\u6709\u7f13\u91ca\u5fae\u4e38\u7684\u91ca\u836f\u884c\u4e3a\u662f\u6b64\u5236\u5242\u5f00\u53d1\u7684\u53e6\u4e00\u6280\u672f\u96be\u70b9\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6279\u95f4\u5dee\u5f02\u7684\u539f\u56e0\u53ef\u8fdb\u4e00\u6b65\u8ffd\u6eaf\u5230\u539f\u8f85\u6599\u6027\u72b6\u7684\u6279\u95f4\u5dee\u5f02\u5bfc\u81f4\u7ec8\u6df7\u7269\u53ef\u538b\u6027\u7684\u6279\u95f4\u5dee\u5f02\uff0c\u8fd9\u4e2a\u95ee\u9898\u662f\u5f88\u5e38\u89c1\u7684\u3002\u5728\u538b\u529b\u63a7\u5236\u65b9\u9762\uff0c\u5bf9\u4e8e\u540c\u4e00\u6279\u7269\u6599\uff0c\u5728\u5feb\u901f\u81ea\u52a8\u5316\u538b\u7247\u8fc7\u7a0b\u4e2d\u6bcf\u4e2a\u836f\u7247\u7684\u538b\u529b\u662f\u96be\u4ee5\u7cbe\u51c6\u63a7\u5236\u7684\u3002\u5982\u679c\u5904\u65b9\u654f\u611f\uff0c\u5fae\u5c0f\u7684\u7247\u91cd\u5dee\u5f02\u6216\u9897\u7c92\u5927\u5c0f\u5dee\u5f02\u90fd\u6709\u53ef\u80fd\u8868\u73b0\u51fa\u6709\u660e\u663e\u7684\u538b\u529b\u5dee\u5f02\uff0c\u8fd9\u4e5f\u662f\u5e38\u89c1\u7684\u3002\u5982\u679c\u6eb6\u51fa\u5ea6\u654f\u611f\u5230\u538b\u529b\u9700\u8981\u7cbe\u51c6\u63a7\u5236\u7684\u8bdd\uff0c\u540c\u4e00\u6279\u4ea7\u54c1\u5c31\u53ef\u80fd\u5b58\u5728\u6eb6\u51fa\u5ea6\u4e0d\u4e00\u81f4\u7684\u836f\u7247\u3002\u957f\u671f\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u7269\u6599\u7684\u6279\u95f4\u5dee\u5f02\u4f1a\u52a0\u5927\u5bf9\u654f\u611f\u5904\u65b9\u7684\u7cbe\u51c6\u538b\u529b\u63a7\u5236\u96be\u5ea6\u800c\u5bfc\u81f4\u6eb6\u51fa\u5ea6\u7684\u9ad8\u53d8\u5f02\u3002\u56e0\u6b64\uff0c\u5e94\u8be5\u8bbe\u8ba1\u5bf9\u538b\u529b\u4e0d\u654f\u611f\u7684\u5904\u65b9\uff0c\u5373\u5728\u4e00\u5b9a\u7684\u8303\u56f4\u5185\u7528\u4ec0\u4e48\u538b\u529b\u90fd\u53ef\u4ee5\uff0c\u8fd9\u6837\u624d\u53ef\u80fd\u4ece\u6839\u672c\u4e0a\u4fdd\u8bc1\u4ea7\u54c1\u6eb6\u51fa\u5ea6\u7684\u4e00\u81f4\u6027\uff0c\u5305\u62ec\u6279\u5185\u4e00\u81f4\u6027\u548c\u6279\u95f4\u4e00\u81f4\u6027\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZDHTK--GBK1-0;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">3.5 \u76f8\u5bf9\u590d\u6742\u7684\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5bf9\u4e8e\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">4<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e2a\u89c4\u683c\u4ea7\u54c1\u8981\u6c42\u4ece\u5982\u4e0b<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">3<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e2a\u65b9\u9762\u5bf9\u4eff\u5236\u5236\u5242\u4e0e\u539f\u7814\u5236\u5242\u662f\u5426\u751f\u7269\u7b49\u6548\u8fdb\u884c\u8bc4\u4ef7\uff1a<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">1<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">47.5 mg<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff0c\u7a7a\u8179\u6761\u4ef6\uff1b<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">190 mg<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff0c\u9910\u540e\u6761\u4ef6\uff1b<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">3<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">190 mg<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff0c\u7a7a\u8179\u6761\u4ef6\u3002\u5982\u679c\u4eff\u5236\u836f\u4e0d\u540c\u89c4\u683c\u4e4b\u95f4\u5904\u65b9\u548c\u6eb6\u51fa\u5ea6\u90fd\u76f8\u4f3c\uff0c\u4e0a\u8ff0\u6210\u529f\u7684<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">BE<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6570\u636e\u5c06\u53ef\u7528\u4e8e\u7533\u8bf7\u8c41\u514d<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">23.75 mg<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u548c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">95 mg<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8fd9<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e2a\u89c4\u683c\u7684\u4f53\u5185<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">BE<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8bd5\u9a8c\u3002\u5982\u679c\u5904\u65b9\u548c\u6eb6\u51fa\u4e0d\u7b26\u5408\u6761\u4ef6\uff0c\u6216\u8005\u5176\u4ed6\u539f\u56e0\uff0c\u5219\u53ef\u80fd\u9700\u8981\u8fdb\u884c\u66f4\u591a\u7684<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">BE<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8bd5\u9a8c\u3002\u8fd9\u4e2a\u76f8\u5bf9\u590d\u6742\u7684<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">BE<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8bd5\u9a8c\u8981\u6c42\u53c8\u8fdb\u4e00\u6b65\u589e\u52a0\u4e86\u4ea7\u54c1\u7684\u5f00\u53d1\u96be\u5ea6\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZDHTK--GBK1-0;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">3.6 \u5de5\u827a\u653e\u5927<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7f13\u91ca\u5fae\u4e38\u7684\u5236\u5907\u9700\u8981\u91c7\u7528\u5305\u8863\u6280\u672f\u3002\u5fae\u4e38\u5305\u8863\u901a\u5e38\u91c7\u7528\u5e95\u55b7\u6d41\u5316\u5e8a\uff08<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">Wurster<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u3002\u6b64\u6280\u672f\u4e2d\u6709\u4f17\u591a\u7684\u5305\u8863\u5de5\u827a\u56e0\u7d20\u4f1a\u76f4\u63a5\u5f71\u54cd\u4ea7\u54c1\u8d28\u91cf\u3002\u4e1a\u754c\u666e\u904d\u8ba4\u4e3a<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">Wurster<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5305\u8863\u5de5\u827a\u4ece\u5c0f\u8bd5\uff08<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">6\u201d<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u5230\u4e2d\u8bd5\uff08<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">18\u201d<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u7684\u653e\u5927\uff0c\u518d\u5230\u5927\u89c4\u6a21\uff08<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">70\u201d<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u7684\u5546\u4e1a\u5316\u751f\u4ea7\u90fd\u6709\u5f88\u5927\u7684\u6311\u6218\u6027\u548c\u96be\u5ea6\u3002\u56e0\u6b64\uff0c\u5982\u4f55\u80fd\u771f\u6b63\u7406\u89e3\u5404\u5de5\u827a\u53c2\u6570\u5bf9\u4ea7\u54c1\u8d28\u91cf\u7684\u5f71\u54cd\uff0c\u8fdb\u800c\u5728\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u5bf9\u5176\u52a0\u4ee5\u63a7\u5236\uff0c\u662f\u4fdd\u8bc1\u6b64\u7c7b\u4ea7\u54c1\u987a\u5229\u751f\u4ea7\u7684\u5173\u952e\u70b9\u3002<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u975e\u5e38\u6ce8\u610f\u7f13\u63a7\u91ca\u5305\u8863\u5de5\u827a\u53ca\u653e\u5927\u5bf9\u4ea7\u54c1\u8d28\u91cf\u7684\u5f71\u54cd\uff0c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u628a\u8be5\u4ea7\u54c1\u5b9a\u4e49\u4e3a\u201c\u9ad8\u98ce\u9669\u4ea7\u54c1\u201d\uff08<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">high risk product<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\uff0c\u56e0\u6b64\u8be5\u4ea7\u54c1\u7684\u653e\u5927\u751f\u4ea7\u5fc5\u987b\u4e8b\u5148\u7ecf\u8fc7<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6279\u51c6\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 21px;font-family: FZDHTK--GBK1-0;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">4 \u8d28\u91cf\u6e90\u4e8e\u8bbe\u8ba1\u7406\u5ff5\u5728\u4ea7\u54c1\u5f00\u53d1\u4e0e\u5ba1\u8bc4\u4e2d\u7684\u5e94\u7528<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u57fa\u4e8e\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u7684\u6280\u672f\u7279\u70b9\u548c\u5386\u53f2\u4e0a\u6709\u591a\u6b21\u4ea7\u54c1\u53ec\u56de\u3001\u64a4\u5e02\u3001\u4ea7\u54c1\u77ed\u7f3a\u7684\u5386\u53f2\u7ecf\u9a8c\uff0c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6df1\u77e5\u6b64\u4ea7\u54c1\u7684\u5f00\u53d1\u96be\u70b9\u3002\u540c\u65f6\uff0c\u8fd1\u5e74\u6765\u4ee5\u79d1\u5b66\u4e3a\u57fa\u7840\u3001\u8d28\u91cf\u6e90\u4e8e\u8bbe\u8ba1\uff08<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">quality by design<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff0c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">QbD<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u7684\u5ba1\u8bc4\u7406\u5ff5\u5df2\u88ab<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5e7f\u6cdb\u7528\u4e8e\u4eff\u5236\u836f\u7684\u5ba1\u8bc4\u3002<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8ba4\u4e3a\u6b64\u4ea7\u54c1\u662f\u9ad8\u98ce\u9669\u4ea7\u54c1\uff0c\u56e0\u6b64\u5728\u4ea7\u54c1\u7684\u7814\u53d1\u9636\u6bb5\uff0c\u5bf9\u5904\u65b9\u548c\u751f\u4ea7\u5de5\u827a\u90fd\u5fc5\u987b\u6709\u5168\u9762\u900f\u5f7b\u7684\u7406\u89e3\u5e76\u5efa\u7acb\u6709\u6548\u63a7\u5236\uff0c\u786e\u4fdd\u5546\u4e1a\u5316\u751f\u4ea7\u4e0d\u51fa\u95ee\u9898\u3002\u5bf9\u8f85\u6599\u6027\u72b6\u8303\u56f4\u3001\u751f\u4ea7\u5de5\u827a\u53c2\u6570\u90fd\u5fc5\u987b\u6709\u4e25\u683c\u63a7\u5236\u5e76\u63d0\u4f9b\u4ea7\u54c1\u8d28\u91cf\u6570\u636e\u4f5c\u4e3a\u652f\u6301\u4f9d\u636e\u3002\u56e0\u6b64\uff0c\u5ba1\u8bc4\u4e0d\u4ec5\u4ec5\u5c40\u9650\u4e8e\u5bf9\u7ec8\u4ea7\u54c1\u8d28\u91cf\u6807\u51c6\u7684\u5ba1\u67e5\uff0c\u8fd8\u5305\u62ec\u901a\u8fc7\u5ba1\u67e5\u4ea7\u54c1\u7684\u5f00\u53d1\u8fc7\u7a0b\uff08\u5305\u62ec\u5236\u5242\u8bbe\u8ba1\u3001\u5904\u65b9\u8003\u5bdf\u53ca\u4f18\u5316\u3001\u5de5\u827a\u9009\u62e9\u3001\u5de5\u827a\u53c2\u6570\u7684\u8003\u5bdf\u53ca\u63a7\u5236\u3001\u5de5\u827a\u653e\u5927\u7b49\uff09\uff0c\u6765\u5224\u522b\u7533\u62a5\u5355\u4f4d\u662f\u5426\u5bf9\u4ea7\u54c1\u5904\u65b9\u4e0e\u5de5\u827a\u6709\u5168\u9762\u7684\u7406\u89e3\uff0c\u662f\u5426\u5bf9\u6574\u4e2a\u5904\u65b9\u548c\u5de5\u827a\u7684\u5173\u952e\u90e8\u5206\u80fd\u6709\u6548\u5730\u52a0\u4ee5\u63a7\u5236\uff0c\u662f\u5426\u6709\u6301\u7eed\u751f\u4ea7\u9ad8\u8d28\u91cf\u4ea7\u54c1\u7684\u80fd\u529b\uff0c\u8fdb\u800c\u6765\u5224\u65ad\u5ba1\u6279\u7684\u98ce\u9669\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u9488\u5bf9\u8fd9\u4e00\u54c1\u79cd\u7684\u7279\u70b9\u548c\u8981\u6c42\uff0c\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u5728\u8be5\u4ea7\u54c1\u7684\u5904\u65b9\u548c\u5de5\u827a\u7814\u53d1\u9636\u6bb5\u5747\u91c7\u7528\u4e86<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">QbD<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7684\u79d1\u5b66\u65b9\u6cd5\u548c\u7406\u5ff5\uff0c\u901a\u8fc7\u5bf9\u5904\u65b9\u7ec4\u6210\u3001\u5de5\u827a\u53c2\u6570\u7684\u6df1\u5165\u7814\u7a76\uff0c\u5168\u9762\u900f\u5f7b\u7406\u89e3\u4ea7\u54c1\u5904\u65b9\u3001\u5de5\u827a\u8bbe\u8ba1\u4ee5\u53ca\u5de5\u827a\u56e0\u7d20\u5bf9\u4ea7\u54c1\u8d28\u91cf\u7684\u5f71\u54cd\uff0c\u5236\u5b9a\u4e86\u5408\u7406\u6709\u6548\u7684\u8fc7\u7a0b\u63a7\u5236\uff0c\u4ece\u6e90\u5934\u4e0a\u786e\u4fdd\u957f\u671f\u5546\u4e1a\u5316\u751f\u4ea7\u4e2d\u836f\u54c1\u4e00\u8d2f\u7684\u9ad8\u54c1\u8d28\u3002\u628a\u4e00\u4e2a\u201c\u9ad8\u98ce\u9669\u4ea7\u54c1\u201d\u5f00\u53d1\u4e3a\u201c\u4f4e\u98ce\u9669\u4ea7\u54c1\u201d\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">QbD<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7406\u5ff5\u7684\u5e94\u7528\u53ef\u4ee5\u6709\u4e0d\u540c\u7684\u505a\u6cd5\u3002\u6b64\u7406\u5ff5\u7684\u6838\u5fc3\u5728\u4e8e\u5728\u957f\u671f\u5546\u4e1a\u5316\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u4ea7\u54c1\u7684<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">CQAs<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u662f\u5426\u80fd\u8fbe\u5230\u9ad8\u6548\u63a7\u5236\u800c\u4e0d\u9700\u8981\u4f9d\u8d56\u5b9e\u9a8c\u5ba4\u7684\u68c0\u9a8c\u6765\u63a7\u5236\u4ea7\u54c1\u8d28\u91cf\u3002\u7b14\u8005\u56e2\u961f\u5728\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u5f00\u53d1\u8fc7\u7a0b\u4e2d\uff0c\u9488\u5bf9\u672c\u4ea7\u54c1\u7684\u7279\u70b9\u548c\u5386\u53f2\u4e0a\u5b58\u5728\u7684\u95ee\u9898\uff0c\u8bc4\u4f30\u4e86\u4ea7\u54c1\u8bbe\u8ba1\u548c\u751f\u4ea7\u56e0\u7d20\u5bf9\u4ea7\u54c1<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">CQAs<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7684\u6f5c\u5728\u5f71\u54cd\uff0c\u7136\u540e\u901a\u8fc7\u5408\u7406\u7684\u5b9e\u9a8c\u8bbe\u8ba1\uff0c\u786e\u5b9a\u4e86\u6700\u7ec8\u7684\u5904\u65b9\u53ca\u5de5\u827a\u53c2\u6570\uff0c\u8fdb\u800c\u4ece\u6839\u672c\u4e0a\u964d\u4f4e\u751a\u81f3\u6392\u9664\u4e86\u6f5c\u5728\u7684\u9690\u60a3\uff0c\u6700\u7ec8\u5b9e\u73b0\u901a\u8fc7\u5408\u7406\u8bbe\u8ba1\u5bf9\u4ea7\u54c1<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">CQAs<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7684\u9ad8\u6548\u63a7\u5236\uff0c\u5b9e\u9a8c\u5ba4\u5206\u6790\u7ed3\u679c\u5728\u7814\u53d1\u9636\u6bb5\u8d77\u5230\u652f\u6301\u4ea7\u54c1\u8bbe\u8ba1\u7684\u4f5c\u7528\uff0c\u800c\u5728\u5546\u4e1a\u5316\u751f\u4ea7\u9636\u6bb5\u5219\u4e3b\u8981\u8d77\u5230\u9a8c\u8bc1\u7684\u4f5c\u7528\u3002<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">QbD<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7406\u5ff5\u5728\u6b64\u4ea7\u54c1\u5f00\u53d1\u8fc7\u7a0b\u4e2d\u7684\u5e94\u7528\u4e3b\u8981\u4f53\u73b0\u5728\u5982\u4e0b\u51e0\u4e2a\u65b9\u9762\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZDHTK--GBK1-0;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">4.1 \u7f13\u91ca\u5fae\u4e38\u4e0e\u7ec8\u4ea7\u54c1\u6eb6\u51fa\u5ea6\u4e00\u81f4<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7531\u4e8e\u672c\u4ea7\u54c1\u662f\u7528\u7f13\u91ca\u5fae\u4e38\u4e0e\u5176\u4ed6\u8f85\u6599\u4e00\u8d77\u538b\u7247\u800c\u6210\uff0c\u538b\u529b\u6709\u53ef\u80fd\u7834\u574f\u5305\u8863\u819c\u800c\u6539\u53d8\u5176\u6eb6\u51fa\u5ea6\uff0c\u56e0\u800c\u9700\u8981\u4e25\u683c\u63a7\u5236\u3002\u6b64\u5916\uff0c\u7247\u91cd\u5dee\u5f02\u95ee\u9898\u4f1a\u4f7f\u538b\u7247\u8fc7\u7a0b\u4e2d\u538b\u529b\u4ea7\u751f\u6ce2\u52a8\uff0c\u8fdb\u4e00\u6b65\u63d0\u9ad8\u538b\u529b\u63a7\u5236\u7684\u96be\u5ea6\uff0c\u56e0\u800c\u60f3\u7b80\u5355\u5730\u901a\u8fc7\u63a7\u5236\u538b\u529b\u6765\u63a7\u5236\u4ea7\u54c1\u8d28\u91cf\u4e00\u81f4\u6027\u5f88\u56f0\u96be\u3002\u6eb6\u51fa\u5ea6\u4e0d\u4e00\u81f4\u7684\u95ee\u9898\u4e5f\u662f\u8be5\u4ea7\u54c1\u7684\u4e3b\u8981\u95ee\u9898\u4e4b\u4e00\u3002\u4e3a\u4e86\u4ece\u6839\u672c\u4e0a\u6d88\u9664\u538b\u7247\u8fc7\u7a0b\u4e2d\u5fae\u4e38\u7f13\u63a7\u5305\u8863\u819c\u88ab\u7834\u574f\u7684\u6f5c\u5728\u98ce\u9669\uff0c\u5728\u6240\u9009\u8bbe\u8ba1\u7406\u5ff5\u4e0b\uff08\u4ee5\u7f13\u91ca\u5fae\u4e38\u4e3a\u57fa\u7840\u7684\u591a\u5355\u5143\u5206\u6563\u578b\u836f\u7247\uff09\uff0c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8981\u6c42\u8be5\u4ea7\u54c1\u7f13\u91ca\u5fae\u4e38\u7684\u6eb6\u51fa\u5ea6\u5fc5\u987b\u4e0e\u7ec8\u4ea7\u54c1\u7247\u5242\u7684\u6eb6\u51fa\u5ea6\u4e00\u81f4\uff0c\u4ee5\u8bc1\u660e\u538b\u529b\u4e0d\u4f1a\u7834\u574f\u5fae\u4e38\u7684\u5305\u8863\u819c\u3002\u540c\u65f6\uff0c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u63d0\u9ad8\u4e86\u5bf9\u9ad8\u98ce\u9669\u4ea7\u54c1\u751f\u4ea7\u8fc7\u7a0b\u7684\u63a7\u5236\uff0c\u8981\u6c42\u7f13\u91ca\u5fae\u4e38\u5fc5\u987b\u68c0\u67e5\u5408\u683c\u653e\u884c\u540e\u624d\u80fd\u7528\u4e8e\u4e0b\u4e00\u6b65\u751f\u4ea7\u3002\u56e0\u6b64\uff0c\u5728\u4ea7\u54c1\u8bbe\u8ba1\u8fc7\u7a0b\u4e2d\uff0c\u4e3a\u4fdd\u8bc1\u5305\u8863\u819c\u5728\u538b\u7247\u8fc7\u7a0b\u4e2d\u4e0d\u88ab\u7834\u574f\uff0c\u5305\u8863\u819c\u5e94\u5177\u6709\u4e00\u5b9a\u7684\u5f39\u6027\uff0c\u540c\u65f6\u5e94\u9009\u62e9\u5177\u6709\u4e00\u5b9a\u5f39\u6027\u7684\u5916\u52a0\u7269\u6599\uff0c\u800c\u4e14\u5916\u52a0\u8f85\u6599\u7528\u91cf\u5e94\u5c3d\u53ef\u80fd\u5145\u8db3\uff1b\u6b64\u5916\u4e3a\u4fdd\u8bc1\u836f\u7247\u7684\u5feb\u901f\u5d29\u89e3\uff0c\u53ef\u5728\u5904\u65b9\u9009\u62e9\u4e2d\u6dfb\u52a0\u8db3\u91cf\u7684\u5d29\u89e3\u5242\u3002\u8054\u4e9a\u836f\u4e1a\u9a8c\u8bc1\u6279\u6b21\u7ed3\u679c\u8868\u660e\uff0c\u7ec8\u6df7\u7269\u6d41\u52a8\u6027\u826f\u597d\uff0c\u5373\u4f7f\u662f\u6700\u4f4e\u5242\u91cf<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">23.75 mg<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4ea7\u54c1\uff08\u7247\u91cd\u5c0f\u4e8e<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">150 mg<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\uff0c\u5728\u957f\u65f6\u95f4\uff08\u7ea6<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">50 h<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u9ad8\u901f\u538b\u7247\u8fc7\u7a0b\u4e2d\u7247\u91cd\u4e5f\u975e\u5e38\u7a33\u5b9a\uff0c\u5e73\u5747\u7247\u91cd\u7a33\u5b9a\u5728\u7406\u8bba\u503c\u7684<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">100%<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u00b1<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">1%<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4ee5\u5185\uff0c\u6700\u5927\u5355\u7247\u91cd\u91cf\u5dee\u5f02\u4e0d\u8d85\u8fc7\u7406\u8bba\u503c\u7684<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">5%<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff08\u89c1\u56fe<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\uff0c\u8fd9\u5bf9\u5fae\u4e38\u538b\u7247\u7684\u5c0f\u836f\u7247\u6765\u8bb2\u5df2\u7ecf\u662f\u5f88\u597d\u7684\u7ed3\u679c\u3002\u5176\u4ed6<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">3<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e2a\u9ad8\u5242\u91cf\u7684\u7247\u91cd\u5dee\u5f02\u66f4\u5c0f\u3002\u751f\u4ea7\u6570\u636e\u8868\u660e\uff0c\u5fae\u4e38\u7f13\u91ca\u5305\u8863\u819c\u5b8c\u6574\u6027\u5728\u8bbe\u5b9a\u7684\u538b\u7247\u538b\u529b\u8303\u56f4\u5185\u4e0d\u53d7\u538b\u529b\u7684\u5f71\u54cd\u3002\u7531\u4e8e\u7f13\u91ca\u7247\u5728\u6c34\u548c\u7f13\u51b2\u6db2\u4e2d\u5feb\u901f\u5d29\u89e3\u91ca\u653e\u51fa\u5fae\u4e38\uff0c\u540e\u8005\u5728\u6eb6\u6db2\u548c\u4f53\u5185\u7f13\u6162\u91ca\u653e\u51fa\u836f\u7269\uff0c\u7f13\u91ca\u5fae\u4e38\u548c\u7f13\u91ca\u7247\u7684\u6eb6\u51fa\u5ea6\u4e00\u81f4\uff0c\u56e0\u6b64\u7f13\u91ca\u7247\u548c\u7f13\u91ca\u5fae\u4e38\u7684\u6eb6\u51fa\u5ea6\u6807\u51c6\u76f8\u540c\u3002\u8868<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">1<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u663e\u793a\u4e0d\u540c\u5242\u91cf\u836f\u7247\u4e0e\u7f13\u91ca\u5fae\u4e38\u6eb6\u51fa\u5ea6\u76f8\u4f3c\uff08<\/span><em style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPS-ItalicMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">f<\/span><\/em><span style=\"max-width: 100%;font-size: 10px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff1e<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">50<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\uff0c\u7b26\u5408\u9884\u671f\u8bbe\u8ba1\u7406\u5ff5\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><img class=\"\"       style=\"box-sizing: border-box !important;word-wrap: break-word !important;width: 592px !important;visibility: visible !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/10-1544149445.png\" alt=\"\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u4e13\u5bb6\u4ee5FDA\u6279\u51c6\u7684\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e3a\u4f8b\u8c08\u9ad8\u7aef\u53e3\u670d\u56fa\u4f53\u7f13\u63a7\u91ca\u5236\u5242\u5f00\u53d1\" title=\"\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u4e13\u5bb6\u4ee5FDA\u6279\u51c6\u7684\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e3a\u4f8b\u8c08\u9ad8\u7aef\u53e3\u670d\u56fa\u4f53\u7f13\u63a7\u91ca\u5236\u5242\u5f00\u53d1\"><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><img class=\"\"       style=\"box-sizing: border-box !important;word-wrap: break-word !important;width: 592px !important;visibility: visible !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/4-1544149445.png\" alt=\"\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u4e13\u5bb6\u4ee5FDA\u6279\u51c6\u7684\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e3a\u4f8b\u8c08\u9ad8\u7aef\u53e3\u670d\u56fa\u4f53\u7f13\u63a7\u91ca\u5236\u5242\u5f00\u53d1\" title=\"\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u4e13\u5bb6\u4ee5FDA\u6279\u51c6\u7684\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e3a\u4f8b\u8c08\u9ad8\u7aef\u53e3\u670d\u56fa\u4f53\u7f13\u63a7\u91ca\u5236\u5242\u5f00\u53d1\"><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZDHTK--GBK1-0;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">4.2 \u4ea7\u54c1\u5747\u5300\u6027<\/span><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6839\u636e\u7f8e\u8054\u90a6\u6cd5\u89c4<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">21CFR211.110<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7684\u8981\u6c42\uff0c\u836f\u54c1\u751f\u4ea7\u8fc7\u7a0b\u5fc5\u987b\u63a7\u5236\u6bcf\u6279\u4e2d\u95f4\u4f53\u548c\u7ec8\u4ea7\u54c1\u7684\u5747\u5300\u5ea6\uff0c\u5305\u62ec<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">BU<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3001<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">CU<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u548c\u5176\u4ed6\u6d4b\u8bd5\u9879\u76ee\u3002\u56e0\u6b64<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8981\u6c42\u63d0\u4f9b\u4e0d\u540c\u6279\u91cf\u4ea7\u54c1<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">BU<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6570\u636e\u3001\u538b\u7247\u8fc7\u7a0b\u7247\u5242<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">CU<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6570\u636e\uff0c\u4ee5\u5224\u65ad\u5de5\u827a\u5bf9\u4ea7\u54c1\u5747\u5300\u6027\u7684\u6f5c\u5728\u98ce\u9669\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">4.2.1<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">\u6df7\u5408\u5747\u5300\u5ea6<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2013<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5e74\u4e4b\u524d<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5bf9<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">BU<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5224\u522b\u7684\u7b2c\u4e00\u9636\u6bb5\u8981\u6c42\u662f\u81f3\u5c11\u53d6\u6837<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">10<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e2a\u4f4d\u7f6e\uff0c\u6bcf\u4e2a\u4f4d\u7f6e\u6d4b\u4e00\u4efd\u5355\u4f4d\u5242\u91cf\u6df7\u5408\u7269\u6599\u4e2d\u7684\u836f\u7269\u542b\u91cf\uff0c\u5982\u679c\u542b\u91cf\u7ed3\u679c\u7684<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">RSD<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u2264<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">5.0%<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff0c\u6240\u6709\u5355\u503c\u90fd\u5728\u5e73\u5747\u503c\u7684\u00b1<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">10%<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4ee5\u5185\uff0c\u5373\u8ba4\u4e3a\u7b26\u5408\u8981\u6c42\u3002\u4f46\u662f\u7531\u4e8e\u8fd9\u79cd\u65b9\u6cd5\u7f3a\u4e4f\u7edf\u8ba1\u5b66\u610f\u4e49\uff0c\u8be5\u6307\u5357\u5df2\u4e8e<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2013<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5e74\u88ab\u5e9f\u6b62\u3002\u76ee\u524d<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5efa\u8bae\u4f7f\u7528<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">ASTM 2709\/2810<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u65b9\u6cd5\uff0c\u5bf9<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">BU<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8981\u6c42\u662f\u5bf9\u6bcf\u4e2a\u4f4d\u7f6e\uff08\u81f3\u5c11<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">10<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e2a\u4f4d\u7f6e\uff09\u6240\u53d6\u7684\u5168\u90e8\u6837\u54c1\uff08\u81f3\u5c11<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">3<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e2a\uff09\u8fdb\u884c\u68c0\u6d4b\uff0c\u6c42\u7ec4\u5185\u548c\u7ec4\u95f4\u6807\u51c6\u5dee\uff0c\u4ee5\u5224\u65ad\u53d6\u6837\u4f4d\u7f6e\u7684\u5f71\u54cd\uff0c\u540c\u65f6\u6240\u6709\u5355\u503c\u90fd\u5fc5\u987b\u5728\u6807\u793a\u91cf\u7684\u00b1<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">10%<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4ee5\u5185\u3002\u76f8\u5173\u6587\u732e\u63d0\u4f9b\u4e86\u5229\u7528\u56fd\u9645\u5236\u836f\u5de5\u7a0b\u534f\u4f1a\uff08<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">ISPE<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">ASTM 2709\/2810<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5bf9<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">BU<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8fdb\u884c\u7edf\u8ba1\u5206\u6790\u7684<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">Excel<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6a21\u677f\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8054\u4e9a\u836f\u4e1a\u4e0d\u540c\u6279\u91cf\u89c4\u683c\u4e0b\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u538b\u7247\u7ec8\u6df7\u7269<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">BU<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7ed3\u679c\u5982\u8868<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6240\u793a\uff0c\u4e2d\u8bd5\u89c4\u6a21<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">BU<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7ed3\u679c\u5355\u503c\u90fd\u5728<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">90.0% ~ 110.0%<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e4b\u95f4\uff0c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">RSD<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff1c<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">5.0%<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff0c\u7b26\u5408\u539f\u6807\u51c6\u8981\u6c42\u3002\u968f\u7740<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5bf9<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">BU<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8981\u6c42\u7684\u63d0\u9ad8\uff0c\u516c\u53f8\u5bf9\u6df7\u5408\u5de5\u827a\u548c\u53d6\u6837\u65b9\u6cd5\u8fdb\u884c\u4e86\u4f18\u5316\u5e76\u653e\u5927\u9a8c\u8bc1\uff0c\u8fdb\u4e00\u6b65\u63d0\u9ad8\u4e86\u4ea7\u54c1\u5747\u5300\u5ea6\u3002\u653e\u5927\u9a8c\u8bc1\u6279\u6b21\u7684\u4e0d\u540c\u89c4\u683c\u4ea7\u54c1\u5176<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">BU<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5e73\u5747\u503c\u5728<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">97.2% ~ 99.2%<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e4b\u95f4\uff0c\u5355\u503c\u5728<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">91.9% ~ 100.1%<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e4b\u95f4\uff0c\u603b\u4f53<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">RSD<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff1c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2.0%<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff0c\u7ec4\u5185\u4e0e\u7ec4\u95f4\u6807\u51c6\u5dee\u90fd\u5c0f\u4e8e<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">1.2%<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3002\u8fd9\u4e9b\u7ed3\u679c\u8868\u660e\u7ec8\u6df7\u7269\u6df7\u5408\u5747\u5300\uff0c\u6df7\u5408\u6b65\u9aa4\u65e0\u4efb\u4f55\u98ce\u9669\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">4.2.2<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">\u542b\u91cf\u5747\u5300\u5ea6<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5bf9\u4e8e<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">CU<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff0c\u7531\u4e8e\u76ee\u524d<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">USP&lt;905&gt;<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7684\u9650\u5ea6\u4ec5\u6709\u5927\u7ea6<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">84%<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7684\u7f6e\u4fe1\u5ea6\u548c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">91%<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7684\u6982\u7387\u4f7f\u7ed3\u679c\u843d\u5728<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">85.0% ~ 115.0%<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e4b\u95f4\uff0c\u6ca1\u6709\u663e\u8457\u7684\u7edf\u8ba1\u5b66\u610f\u4e49\u3002\u7b26\u5408<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">USP&lt;905&gt;<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7b2c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u9636\u6bb5\uff08<\/span><em style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPS-ItalicMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">n<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><\/em><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">= 30<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u8981\u6c42\u7684\u6279\u6b21\u53ef\u80fd\u6709\u4e00\u5b9a\u7684\u4e0d\u5408\u683c\u7387\u3002\u56e0\u6b64<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5df2\u4e0d\u518d\u652f\u6301\u4f7f\u7528<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">USP&lt;905&gt;<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u65b9\u6cd5\u7528\u4e8e\u4ea7\u54c1\u7684\u653e\u884c\u6d4b\u8bd5\u3002\u76ee\u524d<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u63a5\u53d7\u4f7f\u7528<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">ISPE<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u63a8\u8350\u7684\u6839\u636e<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">ASTM 2709\/2810<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7684\u65b9\u6cd5\u548c\u6307\u6807\u6765\u68c0\u9a8c\u548c\u63a7\u5236\u4ea7\u54c1\u5242\u91cf\u5355\u4f4d\u542b\u91cf\u5747\u5300\u6027\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u5728\u6574\u4e2a\u538b\u7247\u8fc7\u7a0b\u4e2d\u5927\u7ea6\u5e73\u5206<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">20<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e2a\u65f6\u95f4\u70b9\u53d6\u6837\uff0c\u6bcf\u70b9\u5206\u6790<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">3<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7247\uff0c\u5171\u5206\u6790<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">60<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7247\u7684\u5355\u7247\u542b\u91cf\uff0c\u7edf\u8ba1\u5206\u6790\u7ec4\u95f4\u5dee\u5f02\u548c\u7ec4\u5185\u5dee\u5f02\uff0c\u91c7\u7528<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">ASTM2709\/2810 Plan 2<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7684\u6807\u51c6\uff0c\u4ee5<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">100%<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7406\u8bba\u503c\u4f5c\u4e3a\u76ee\u6807\uff0c\u4ee5<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">90%<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7f6e\u4fe1\u5ea6\u548c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">95%<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7684\u6982\u7387\u4e0b\u9650\u7684\u8303\u56f4\uff0c\u6765\u5224\u65ad\u5242\u91cf\u5355\u4f4d\u7684\u8fc7\u7a0b<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">CU<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u662f\u5426\u7b26\u5408\u8981\u6c42\u3002\u8054\u4e9a\u836f\u4e1a\u4e0d\u540c\u5242\u91cf\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e0d\u540c\u751f\u4ea7\u6279\u91cf\u89c4\u683c\u4e0b\uff0c\u8fc7\u7a0b<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">CU<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7ed3\u679c\u89c1\u8868<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">3<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3002\u7ed3\u679c\u663e\u793a\uff0c\u4ea7\u54c1\u6700\u5c11\u5177\u6709<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">90%<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7684\u7f6e\u4fe1\u5ea6\u4ee5\u53ca<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">95%<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7684\u6982\u7387\u7b26\u5408\u5242\u91cf\u5747\u5300\u5ea6\u8981\u6c42\uff0c\u56e0\u6b64\u672c\u54c1\u538b\u7247\u8fc7\u7a0b\u65e0\u5206\u79bb\u98ce\u9669\uff0c\u4ea7\u54c1\u9ad8\u5ea6\u5747\u5300\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><img class=\"\"       style=\"box-sizing: border-box !important;word-wrap: break-word !important;width: 592px !important;visibility: visible !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/10-1544149445-1.png\" alt=\"\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u4e13\u5bb6\u4ee5FDA\u6279\u51c6\u7684\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e3a\u4f8b\u8c08\u9ad8\u7aef\u53e3\u670d\u56fa\u4f53\u7f13\u63a7\u91ca\u5236\u5242\u5f00\u53d1\" title=\"\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u4e13\u5bb6\u4ee5FDA\u6279\u51c6\u7684\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e3a\u4f8b\u8c08\u9ad8\u7aef\u53e3\u670d\u56fa\u4f53\u7f13\u63a7\u91ca\u5236\u5242\u5f00\u53d1\"><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><img class=\"\"       style=\"box-sizing: border-box !important;word-wrap: break-word !important;width: 592px !important;visibility: visible !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/7-1544149446.png\" alt=\"\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u4e13\u5bb6\u4ee5FDA\u6279\u51c6\u7684\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e3a\u4f8b\u8c08\u9ad8\u7aef\u53e3\u670d\u56fa\u4f53\u7f13\u63a7\u91ca\u5236\u5242\u5f00\u53d1\" title=\"\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u4e13\u5bb6\u4ee5FDA\u6279\u51c6\u7684\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e3a\u4f8b\u8c08\u9ad8\u7aef\u53e3\u670d\u56fa\u4f53\u7f13\u63a7\u91ca\u5236\u5242\u5f00\u53d1\"><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZDHTK--GBK1-0;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">4.3 \u53ef\u63b0\u5206\u6027<\/span><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u9274\u4e8e\u539f\u7814\u5236\u5242\u4e3a\u53ef\u63b0\u5206\u7247\uff0c\u4eff\u5236\u836f\u9700\u53c2\u7167<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6307\u5bfc\u539f\u5219\u7814\u7a76\u7247\u5242\u7684\u53ef\u63b0\u5206\u6027\uff0c\u5e76\u63d0\u4f9b\u6240\u6709\u5242\u91cf\u4ea7\u54c1\u7684\u5982\u4e0b\u6570\u636e\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">1<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u9664\u5b8c\u6574\u7247\u9700\u6ee1\u8db3\u5e38\u89c4\u7684\u4eba\u7528\u836f\u54c1\u6ce8\u518c\u6280\u672f\u8981\u6c42\u56fd\u9645\u534f\u8c03\u4f1a\u8bae\uff08<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">ICH<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u7a33\u5b9a\u6027\u8bd5\u9a8c\u4e4b\u5916\uff0c\u63b0\u5206\u540e\u7684\u5206\u5272\u7247\u6bb5\u5728\u533b\u7528\u50a8\u836f\u76d2<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">\/<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u74f6\u4e2d\uff08\u65e0\u5bc6\u5c01\uff0c\u65e0\u5e72\u71e5\u5242\uff09\uff0c\u5728\u6e29\u5ea6<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">25<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u2103 \u00b1<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u2103\u3001\u76f8\u5bf9\u6e7f\u5ea6<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">60%<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u00b1<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">5%<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7684\u6761\u4ef6\u4e0b\uff0c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">90 d<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5185\u4fdd\u6301\u7a33\u5b9a\uff1b<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u4ee5\u4e0b\u8bd5\u9a8c\u9700\u5206\u522b\u5728\u5668\u68b0\uff08\u5207\u7247\u5668\uff09\u63b0\u5206\u53ca\u624b\u5de5\u63b0\u5206\u6761\u4ef6\u4e0b\u8fdb\u884c\uff1a\u63b0\u5206\u540e\u7684\u7247\u6bb5\u5747\u5e94\u7b26\u5408\u76f8\u5e94\u5242\u91cf\u836f\u7247\u7684\u8d28\u91cf\u6807\u51c6\uff1b\u63b0\u5206\u540e\u7684\u7247\u6bb5<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">CU<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u9700\u6ee1\u8db3<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">USP&lt;905&gt;<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6807\u51c6\uff1b<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">15<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7247\u836f\u7247\u63b0\u5206\u540e\uff0c\u8d28\u91cf\u635f\u5931\u5c0f\u4e8e<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">3.0%<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff1b\u63b0\u5206\u540e\u7247\u6bb5\u8106\u788e\u5ea6\u5e94\u7b26\u5408<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">USP<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6807\u51c6\uff1b\u5b8c\u6574\u836f\u7247\u4e0e\u63b0\u5206\u540e\u7247\u6bb5\u6eb6\u51fa\u5ea6\u6bd4\u8f83\uff0c<\/span><em style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPS-ItalicMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">f<\/span><\/em><span style=\"max-width: 100%;font-size: 10px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5e94\u5927\u4e8e<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">50<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff08<\/span><em style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPS-ItalicMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">n<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><\/em><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">= 12<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\uff1b\u538b\u7247\u524d\u9897\u7c92\u4e0e\u5b8c\u6574\u836f\u7247\u6eb6\u51fa\u5ea6\u6bd4\u8f83\uff0c<\/span><em style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPS-ItalicMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">f<\/span><\/em><span style=\"max-width: 100%;font-size: 10px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5e94\u5927\u4e8e<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">50<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff0c\u4ee5\u786e\u4fdd\u538b\u7247\u8fc7\u7a0b\u4e2d\u7f13\u91ca\u5fae\u4e38\u5305\u8863\u819c\u672a\u88ab\u7834\u574f\u3002\u540e<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">4<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u9879\u8bd5\u9a8c\u5e94\u5bf9\u6bcf\u4e2a\u5242\u91cf\u836f\u7247\u786c\u5ea6\u8303\u56f4\u9ad8\u4f4e\u9650\u5747\u8fdb\u884c\u8003\u5bdf\uff0c\u4ee5\u786e\u5b9a\u5728\u7ebf\u68c0\u6d4b\u786c\u5ea6\u8303\u56f4\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u5404\u5242\u91cf\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u63b0\u5206\u6027\u7ed3\u679c\u5747\u7b26\u5408<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7684\u8981\u6c42\uff08\u89c1\u8868<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">4<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u3002\u901a\u8fc7\u5bf9\u9ad8\u538b\u529b\u548c\u4f4e\u538b\u529b\u751f\u4ea7\u7684\u4e0d\u540c\u5242\u91cf\u7247\u5242\uff0c\u5206\u522b\u7528\u624b\u5de5\u63b0\u5206\u548c\u7528\u5207\u7247\u5668\u8fdb\u884c\u5668\u68b0\u63b0\u5206\u540e\u6d4b\u5b9a\u8106\u788e\u5ea6\u3001\u5355\u7247\u91cd\u91cf\u635f\u5931\u548c\u6eb6\u51fa\u5ea6\uff0c\u7ed3\u679c\u5747\u7b26\u5408\u8981\u6c42\u3002\u7279\u522b\u662f\u6eb6\u51fa\u5ea6\uff0c\u6240\u6709<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">4<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e2a\u5242\u91cf\u89c4\u683c\u7247\u5242\u7684\u63b0\u5206\u7247\u6bb5\u7684\u6eb6\u51fa\u5ea6\u4e0e\u5b8c\u6574\u7247\u975e\u5e38\u76f8\u4f3c\uff08<\/span><em style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPS-ItalicMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">f<\/span><\/em><span style=\"max-width: 100%;font-size: 10px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u2265<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">68<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\uff0c\u5373\u63b0\u5206\u7247\u4e0e\u6574\u7247\u7684\u6eb6\u51fa\u5ea6\u7684\u5e73\u5747\u5dee\u5f02\u5c0f\u4e8e<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">5%<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3002\u8fd9\u8bc1\u660e\u63b0\u5206\u867d\u7136\u589e\u52a0\u4e86\u5355\u4f4d\u5242\u91cf\u8868\u9762\u79ef\u4f46\u4e0d\u5f71\u54cd\u6eb6\u51fa\u5ea6\uff0c\u8fd9\u4e0e\u4ea7\u54c1\u7684\u6700\u521d\u8bbe\u8ba1\u76f8\u7b26\u5408\uff0c\u5373\u7f13\u91ca\u5fae\u4e38\u4e3a\u57fa\u7840\u7684\u591a\u5355\u5143\u5206\u6563\u7247\u5242\uff0c\u540c\u65f6\u4e5f\u8868\u660e\u63b0\u5206\u53ef\u4ee5\u83b7\u5f97\u51c6\u786e\u7684\u534a\u7247\u5242\u91cf\u3002\u63b0\u5206\u540e\u7247\u6bb5\u5242\u91cf\u7684\u7cbe\u51c6\u6027\u53ef\u4ece\u7247\u6bb5\u542b\u91cf\u5747\u5300\u6027\u5f97\u5230\u786e\u8ba4\u3002\u65e0\u8bba\u662f\u624b\u5de5\u63b0\u5206\u8fd8\u662f\u5668\u68b0\u63b0\u5206\uff0c\u4e0d\u540c\u5242\u91cf\u7684\u63b0\u5206\u7247\u6bb5\u542b\u91cf\u5747\uff1e<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">96%<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff0c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">AV<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff1c<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">10<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff0c\u5b8c\u5168\u7b26\u5408<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">USP<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7684\u8981\u6c42\u3002\u56e0\u6b64\uff0c\u7247\u5242\u53ef\u4ee5\u901a\u8fc7\u63b0\u5206\u63d0\u4f9b\u51c6\u786e\u7684\u5242\u91cf\uff0c\u65b9\u4fbf\u5242\u91cf\u8c03\u6574\u4e0e\u670d\u7528\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u540c\u65f6\uff0c\u5728\u4e2d\u8bd5\u6279\u91cf\u89c4\u683c\u548c\u5546\u4e1a\u5316\u751f\u4ea7\u6279\u91cf\u89c4\u683c\u4e0b\uff0c\u751f\u4ea7\u6240\u5f97\u8be5\u4ea7\u54c1\u4e0d\u540c\u5242\u91cf\u5b8c\u6574\u836f\u7247\u4e0e\u538b\u7247\u524d\u7ec8\u6df7\u7269\u7684\u6eb6\u51fa\u5ea6\u76f8\u6bd4\uff0c<\/span><em style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPS-ItalicMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">f<\/span><\/em><span style=\"max-width: 100%;font-size: 10px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5747\u5927\u4e8e<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">60<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff0c\u6eb6\u51fa\u5ea6\u76f8\u4f3c\uff0c\u8868\u660e\u538b\u7247\u8fc7\u7a0b\u4e2d\u538b\u529b\u672a\u9020\u6210\u5fae\u4e38\u5305\u8863\u5c42\u7684\u7834\u574f\uff08\u89c1\u8868<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">5<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u3002\u6b64\u5916\uff0c\u7a33\u5b9a\u6027\u8bd5\u9a8c\u7ed3\u679c\u8868\u660e\uff0c\u63b0\u5206\u7247\u6bb5\u5728\u533b\u7528\u50a8\u836f\u76d2<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">\/<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u74f6\u4e2d\u7a33\u5b9a\u3002\u4ee5\u4e0a\u6570\u636e\u8868\u660e\uff0c\u672c\u54c1\u7684\u5904\u65b9\u8bbe\u8ba1\u548c\u5de5\u827a\u90fd\u6709\u5f88\u597d\u7684\u8010\u7528\u6027\uff0c\u4ea7\u54c1\u53ef\u63b0\u5206\u6027\u826f\u597d\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><img class=\"\"       style=\"box-sizing: border-box !important;word-wrap: break-word !important;width: 592px !important;visibility: visible !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/9-1544149447.png\" alt=\"\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u4e13\u5bb6\u4ee5FDA\u6279\u51c6\u7684\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e3a\u4f8b\u8c08\u9ad8\u7aef\u53e3\u670d\u56fa\u4f53\u7f13\u63a7\u91ca\u5236\u5242\u5f00\u53d1\" title=\"\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u4e13\u5bb6\u4ee5FDA\u6279\u51c6\u7684\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e3a\u4f8b\u8c08\u9ad8\u7aef\u53e3\u670d\u56fa\u4f53\u7f13\u63a7\u91ca\u5236\u5242\u5f00\u53d1\"><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><img class=\"\"       style=\"box-sizing: border-box !important;word-wrap: break-word !important;width: 592px !important;visibility: visible !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/10-1544149447.png\" alt=\"\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u4e13\u5bb6\u4ee5FDA\u6279\u51c6\u7684\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e3a\u4f8b\u8c08\u9ad8\u7aef\u53e3\u670d\u56fa\u4f53\u7f13\u63a7\u91ca\u5236\u5242\u5f00\u53d1\" title=\"\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u4e13\u5bb6\u4ee5FDA\u6279\u51c6\u7684\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e3a\u4f8b\u8c08\u9ad8\u7aef\u53e3\u670d\u56fa\u4f53\u7f13\u63a7\u91ca\u5236\u5242\u5f00\u53d1\"><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZDHTK--GBK1-0;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">4.4 \u5173\u952e\u5de5\u827a\u53c2\u6570\u53ef\u63a5\u53d7\u8303\u56f4\u7684\u786e\u5b9a<\/span><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6839\u636e\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u7684\u8bbe\u8ba1\u7406\u5ff5\uff0c\u7f13\u91ca\u5305\u8863\u5fae\u4e38\u7684\u6eb6\u51fa\u5ea6\u51b3\u5b9a\u4e86\u7ec8\u4ea7\u54c1\u7684\u6eb6\u51fa\u5ea6\u3002\u540c\u65f6\uff0c\u538b\u7247\u8fc7\u7a0b\u4e2d\u5fc5\u987b\u907f\u514d\u538b\u529b\u9020\u6210\u5fae\u4e38\u5305\u8863\u819c\u7684\u7834\u574f\uff0c\u786e\u4fdd\u7ec8\u4ea7\u54c1\u7684\u6eb6\u51fa\u5ea6\u4e0d\u53d7\u538b\u7247\u5de5\u827a\u7684\u5f71\u54cd\u3002\u7f13\u91ca\u5fae\u4e38\u5236\u5907\u540e\u9700\u52a0\u5165\u5176\u4ed6\u8f85\u6599\u624d\u80fd\u538b\u7247\uff0c\u5728\u8fd9\u4e2a\u8fc7\u7a0b\u4e2d<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">BU<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5f88\u91cd\u8981\u3002\u53e6\u5916\uff0c\u89c4\u6a21\u5546\u4e1a\u5316\u751f\u4ea7\u4e2d\u6f2b\u957f\u7684\u8fde\u7eed\u538b\u7247\u8fc7\u7a0b\uff08\u5982\u538b\u7247\u65f6\u95f4\uff1e<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">10 h<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u662f\u5426\u4f1a\u51fa\u73b0\u5fae\u4e38\u4e0e\u8f85\u6599\u5206\u79bb\u800c\u5f71\u54cd<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">CU<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff0c\u4e5f\u662f\u6b64\u4ea7\u54c1\u7684\u5173\u952e\u70b9\u4e4b\u4e00\u3002\u56e0\u6b64\uff0c\u53ef\u80fd\u53d7\u751f\u4ea7\u5de5\u827a\u5f71\u54cd\u7684\u4ea7\u54c1<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">CQAs<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5305\u62ec\u5747\u5300\u5ea6\uff08<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">BU<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u548c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">CU<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u548c\u6eb6\u51fa\u5ea6\u3002\u5173\u952e\u751f\u4ea7\u5de5\u827a\u6b65\u9aa4\uff08<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">critical process<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff0c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">CP<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u5305\u62ec\u7f13\u91ca\u8584\u819c\u5305\u8863\u3001\u6df7\u5408\u3001\u538b\u7247\u3002\u6bcf\u4e2a\u5173\u952e\u5de5\u5e8f\u4e2d\u7684\u91cd\u8981\u53c2\u6570\u5219\u662f\u5173\u952e\u5de5\u827a\u53c2\u6570\uff08<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">critical process parameter<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff0c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">CPP<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u3002\u5176\u4ed6\u5de5\u5e8f\u5bf9\u4ea7\u54c1\u7684<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">CQAs<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5f71\u54cd\u8f83\u5c0f\u751a\u81f3\u65e0\u5f71\u54cd\uff0c\u56e0\u6b64\u98ce\u9669\u6bd4\u8f83\u4f4e\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">4.4.1<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">\u5305\u8863\u5de5\u827a\u53c2\u6570\u53ef\u63a5\u53d7\u8303\u56f4\u7684\u786e\u5b9a<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8981\u6c42\u6709\u6570\u636e\u652f\u6301<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">CPPs<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7684\u9650\u5ea6\u8303\u56f4\u3002\u6839\u636e\u5bf9\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u7684\u4e86\u89e3\u548c\u7ecf\u9a8c\uff0c\u7b14\u8005\u56e2\u961f\u5728\u62df\u5b9a\u7684\u5305\u8863\u53c2\u6570\u8303\u56f4\u5185\u6309\u5404\u4e2a\u53c2\u6570\u7684\u56fa\u6709\u7279\u6027\uff0c\u7ec4\u5408\u4e86<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5957\u6781\u7aef\u7684\u5305\u8863\u53c2\u6570\uff0c\u5206\u522b\u8fdb\u884c\u5fae\u4e38\u5305\u8863\uff0c\u6bd4\u8f83\u6240\u5f97\u7684\u7f13\u91ca\u5fae\u4e38\u6eb6\u51fa\u5ea6\u3002\u53ea\u8981\u5728\u6b64<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u79cd\u6781\u7aef\u6761\u4ef6\u4e0b\u751f\u4ea7\u6240\u5f97\u7684\u7f13\u91ca\u5fae\u4e38\u6eb6\u51fa\u5ea6\u4e00\u81f4\uff0c\u5b9e\u9645\u751f\u4ea7\u5de5\u827a\u8fc7\u7a0b\u4e2d\u5728\u62df\u5b9a\u53c2\u6570\u8303\u56f4\u5185\u7684\u5fae\u8c03\u5c31\u5747\u53ef\u4ee5\u83b7\u5f97\u6eb6\u51fa\u4e00\u81f4\u7684\u7f13\u91ca\u5305\u8863\u5fae\u4e38\uff0c\u6700\u7ec8\u786e\u4fdd\u957f\u671f\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u7684\u6279\u95f4\u4e00\u81f4\u6027\u3002\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u5728\u6b64<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u79cd\u6781\u7aef\u6761\u4ef6\u4e0b\u5305\u8863\u6240\u5f97\u7f13\u91ca\u5fae\u4e38\u6eb6\u51fa\u5ea6<\/span><em style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPS-ItalicMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">f<\/span><\/em><span style=\"max-width: 100%;font-size: 10px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e3a<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">62<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff0c\u663e\u793a\u516c\u53f8\u6700\u7ec8\u786e\u5b9a\u7684\u5de5\u827a\u5177\u6709\u8f83\u597d\u7684\u8010\u7528\u6027\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">4.4.2<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">\u6df7\u5408\u8fc7\u7a0b\u6df7\u5408\u65f6\u95f4\u8303\u56f4\u7684\u786e\u5b9a<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7b14\u8005\u56e2\u961f\u5bf9\u4e0d\u540c\u6df7\u5408\u65f6\u95f4\u4e0b\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7ec8\u6df7\u7269<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">BU<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8fdb\u884c\u4e86\u8003\u5bdf\u3002\u7ed3\u679c\u663e\u793a\uff0c\u5728\u62df\u5b9a\u7684\u6781\u7aef\u6df7\u5408\u65f6\u95f4\u4e0b\uff0c\u7ec8\u6df7\u7269\u6df7\u5408\u5747\u5300\u6027\u826f\u597d\uff08\u89c1\u8868<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">6<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;text-align: center;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><img class=\"\"       style=\"box-sizing: border-box !important;word-wrap: break-word !important;width: 592px !important;visibility: visible !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/4-1544149448.png\" alt=\"\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u4e13\u5bb6\u4ee5FDA\u6279\u51c6\u7684\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e3a\u4f8b\u8c08\u9ad8\u7aef\u53e3\u670d\u56fa\u4f53\u7f13\u63a7\u91ca\u5236\u5242\u5f00\u53d1\" title=\"\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u4e13\u5bb6\u4ee5FDA\u6279\u51c6\u7684\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e3a\u4f8b\u8c08\u9ad8\u7aef\u53e3\u670d\u56fa\u4f53\u7f13\u63a7\u91ca\u5236\u5242\u5f00\u53d1\"><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">4.4.3<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">\u538b\u7247\u8fc7\u7a0b\u538b\u529b\u8303\u56f4\u7684\u786e\u5b9a<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e00\u4e2a\u4ea7\u54c1\u7684\u8d28\u91cf\u8bbe\u8ba1\u901a\u5e38\u8981\u6839\u636e\u5177\u4f53\u60c5\u51b5\u4ece\u591a\u65b9\u9762\u540c\u65f6\u8fdb\u884c\u3002\u542b\u7f13\u91ca\u5fae\u4e38\u7684\u7247\u5242\u9664\u4e86\u5904\u65b9\u7684\u8bbe\u8ba1\u8981\u5408\u7406\u4ee5\u5916\uff0c\u751f\u4ea7\u8fc7\u7a0b\u8fd8\u5fc5\u987b\u4e25\u683c\u63a7\u5236\u538b\u529b\uff0c\u53ea\u6709\u8fd9\u6837\u624d\u80fd\u786e\u4fdd\u538b\u7247\u8fc7\u7a0b\u4e2d\u7f13\u91ca\u5fae\u4e38\u7684\u5305\u8863\u819c\u4e0d\u53d7\u538b\u529b\u7684\u7834\u574f\u3002\u7528\u4e8e\u8fc7\u7a0b\u63a7\u5236\u7684\u538b\u529b\u8303\u56f4\u5fc5\u987b\u6709\u4ea7\u54c1\u6eb6\u51fa\u5ea6\u6570\u636e\u652f\u6301\u3002\u5bf9\u8054\u4e9a\u836f\u4e1a\u4e0d\u540c\u5242\u91cf\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u5728\u6240\u8003\u5bdf\u7684\u538b\u529b\u8303\u56f4\u5185\uff0c\u9ad8\u4f4e\u538b\u529b\u4e0b\u7684\u6eb6\u51fa\u5ea6\u8fdb\u884c\u6bd4\u8f83\uff0c<\/span><em style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPS-ItalicMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">f<\/span><\/em><span style=\"max-width: 100%;font-size: 10px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5206\u522b\u4e3a<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">81<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff08<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">23.75 mg<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u3001<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">75<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff08<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">47.5 mg<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u3001<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">71<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff08<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">95 mg<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09 \u548c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">76<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff08<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">190 mg<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\uff0c \u8868\u660e\u6eb6\u51fa\u5ea6\u4e00\u81f4\uff0c\u800c\u4e14\u7247\u5242\u7684\u6eb6\u51fa\u5ea6\u4e0e\u5fae\u4e38\u7684\u6eb6\u51fa\u5ea6\u4e00\u81f4\uff08\u89c1\u8868<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">1<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u3002\u540c\u65f6\uff0c\u7efc\u5408\u8003\u8651\u63b0\u5206\u6027\u7ed3\u679c\uff0c\u786e\u5b9a\u4e86\u6700\u7ec8\u4ea7\u54c1\u538b\u7247\u8fc7\u7a0b\u4e2d\u7684\u53ef\u7528\u538b\u529b\u8303\u56f4\uff0c\u53ef\u7528\u4e8e\u5546\u4e1a\u5316\u7684\u751f\u4ea7\u63a7\u5236\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZDHTK--GBK1-0;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">4.5 \u6279\u91cf\u653e\u5927<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6279\u91cf\u653e\u5927\u53ef\u80fd\u76f4\u63a5\u5f71\u54cd\u4ea7\u54c1\u8d28\u91cf\u3002\u56e0\u6b64\uff0c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8981\u6c42\u5728\u6b63\u5f0f\u5546\u4e1a\u5316\u751f\u4ea7\u524d\u5fc5\u987b\u63d0\u4f9b\u62df\u5546\u4e1a\u5316\u751f\u4ea7\u6279\u91cf\u4e0b\u7684\u6570\u636e\uff0c\u540c\u65f6\u4e8b\u5148\u7ecf\u8fc7<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6279\u51c6\uff0c\u4ee5\u4fdd\u8bc1\u957f\u671f\u5546\u4e1a\u5316\u4ea7\u54c1\u4e0e<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">BE<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6279\u6b21\u4ea7\u54c1\u7684\u8d28\u91cf\u4e00\u81f4\u3002\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u5728\u56de\u590d<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7f3a\u9677\u4fe1\uff08<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">deficiency letter<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u65f6\uff0c\u5df2\u5bf9\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u5728\u5546\u4e1a\u5316\u751f\u4ea7\u89c4\u6a21\u4e0b\u7684\u5de5\u827a\u53c2\u6570\u8fdb\u884c\u4e86\u8be6\u5c3d\u7684\u7814\u7a76\u5e76\u62a5\u9001<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3002\u8054\u4e9a\u836f\u4e1a\u5728\u4e2d\u8bd5\u7533\u62a5<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">BE<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6279\u6b21\u548c\u653e\u5927\u9a8c\u8bc1\u6279\u6b21\u4e0d\u540c\u6279\u91cf\u89c4\u683c\u4e0b\uff0c\u5bf9\u751f\u4ea7\u6240\u5f97\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u5fae\u4e38\u53ca\u4e0d\u540c\u5242\u91cf\u89c4\u683c\u7f13\u91ca\u7247\u6eb6\u51fa\u5ea6\u8fdb\u884c\u6bd4\u8f83\uff0c<\/span><em style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPS-ItalicMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">f<\/span><\/em><span style=\"max-width: 100%;font-size: 10px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5206\u522b\u4e3a<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">68<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff08\u7f13\u91ca\u5fae\u4e38\uff09\u3001<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">71<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff08<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">23.75 mg<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7f13\u91ca\u7247\uff09\u3001<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">65<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff08<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">47.5 mg<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7f13\u91ca\u7247\uff09\u3001<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">67<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff08<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">95 mg<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7f13\u91ca\u7247\uff09\u548c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">70<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff08<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">190mg<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7f13\u91ca\u7247\uff09\uff0c\u8868\u660e\u5546\u4e1a\u5316\u751f\u4ea7\u6279\u6b21\u4ea7\u54c1\u8d28\u91cf\u4e0e<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">BE<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6279\u6b21\u4ea7\u54c1\u8d28\u91cf\u4e00\u81f4\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 21px;font-family: FZDHTK--GBK1-0;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">5 \u751f\u7269\u7b49\u6548\u6027<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4eff\u5236\u836f\u53ea\u6709\u540c\u65f6\u6ee1\u8db3\u4e0e\u539f\u7814\u836f\u7684\u836f\u5b66\u7b49\u6548\u548c\u751f\u7269\u7b49\u6548\uff0c\u624d\u80fd\u8fbe\u5230\u4e0e\u539f\u7814\u836f\u5728\u4e34\u5e8a\u4f7f\u7528\u4e0a\u7684\u76f8\u4e92\u66ff\u4ee3\uff0c\u624d\u80fd\u4f7f\u60a3\u8005\u65e0\u8bba\u662f\u670d\u7528\u4eff\u5236\u836f\u8fd8\u662f\u670d\u7528\u539f\u7814\u836f\u5747\u53ef\u83b7\u5f97\u76f8\u540c\u7684\u7597\u6548\u3002\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u4ee5<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5173\u4e8e\u6b64\u5236\u5242\u7684<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">BE<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6307\u5bfc\u539f\u5219\u7684\u8981\u6c42\u4e3a\u57fa\u7840\uff0c\u5bf9\u81ea\u5236\u7684<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">47.5 mg<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u548c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">190 mg<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u5206\u522b\u4e0e\u76f8\u5bf9\u5e94\u5242\u91cf\u7684\u53c2\u6bd4\u5236\u5242\u5f00\u5c55\u4e86\u7a7a\u8179\u548c\u9910\u540e\u5171<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">4<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6b21<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">BE<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8bd5\u9a8c\u3002\u7ed3\u679c\u663e\u793a\uff0c\u5357\u901a\u8054\u4e9a\u836f\u4e1a<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">47.5 mg<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u548c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">190 mg<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8fd9<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u79cd\u4e0d\u540c\u89c4\u683c\u4eff\u5236\u5236\u5242\u7684\u5404\u9879\u836f\u52a8\u5b66\u53c2\u6570<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">90%<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7f6e\u4fe1\u533a\u95f4\uff08<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">CI<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u5747\u843d\u5728<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">80.00% ~ 125.00%BE<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8981\u6c42\u5185\uff0c\u5b9e\u73b0\u4e86\u4e0e\u539f\u7814\u5236\u5242\u7684\u751f\u7269\u7b49\u6548\uff0c\u56e0\u6b64\u5728\u4e34\u5e8a\u4e0a\u5b8c\u5168\u53ef\u4e0e\u539f\u7814\u5236\u5242\u76f8\u4e92\u66ff\u4ee3\u4f7f\u7528\uff08\u89c1\u8868<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">7<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u548c\u8868<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">8<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><img class=\"\"       style=\"box-sizing: border-box !important;word-wrap: break-word !important;width: 592px !important;visibility: visible !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/0-1544149448.png\" alt=\"\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u4e13\u5bb6\u4ee5FDA\u6279\u51c6\u7684\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e3a\u4f8b\u8c08\u9ad8\u7aef\u53e3\u670d\u56fa\u4f53\u7f13\u63a7\u91ca\u5236\u5242\u5f00\u53d1\" title=\"\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u4e13\u5bb6\u4ee5FDA\u6279\u51c6\u7684\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e3a\u4f8b\u8c08\u9ad8\u7aef\u53e3\u670d\u56fa\u4f53\u7f13\u63a7\u91ca\u5236\u5242\u5f00\u53d1\"><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><img class=\"\"       style=\"box-sizing: border-box !important;word-wrap: break-word !important;width: 592px !important;visibility: visible !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/6-1544149448.png\" alt=\"\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u4e13\u5bb6\u4ee5FDA\u6279\u51c6\u7684\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e3a\u4f8b\u8c08\u9ad8\u7aef\u53e3\u670d\u56fa\u4f53\u7f13\u63a7\u91ca\u5236\u5242\u5f00\u53d1\" title=\"\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u4e13\u5bb6\u4ee5FDA\u6279\u51c6\u7684\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e3a\u4f8b\u8c08\u9ad8\u7aef\u53e3\u670d\u56fa\u4f53\u7f13\u63a7\u91ca\u5236\u5242\u5f00\u53d1\"><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 21px;font-family: FZDHTK--GBK1-0;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">6 \u957f\u671f\u5546\u4e1a\u5316\u751f\u4ea7\u6279\u6b21\u4ea7\u54c1\u7279\u6027<\/span><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e0e\u539f\u7814\u836f\u7684\u8d28\u91cf\u548c\u7597\u6548\u4e00\u81f4\u662f\u4eff\u5236\u836f\u4e00\u81f4\u6027\u8bc4\u4ef7\u7cfb\u7edf\u5de5\u7a0b\u7684\u4e00\u4e2a\u65b9\u9762\uff0c\u5982\u4f55\u786e\u4fdd\u8fd9\u4e9b\u5df2\u901a\u8fc7\u8bc4\u4ef7\u786e\u8ba4\u4e3a\u7597\u6548\u548c\u8d28\u91cf\u4e00\u81f4\u7684\u4eff\u5236\u5236\u5242\u80fd\u591f\u5728\u9075\u5faa\u836f\u54c1\u751f\u4ea7\u7ba1\u7406\u89c4\u8303\u6761\u4ef6\u4e0b\u88ab\u6301\u7eed\u4e14\u7a33\u5b9a\u5730\u751f\u4ea7\u51fa\u6765\uff0c\u5373\u786e\u4fdd\u5176\u4e00\u8d2f\u7684\u8d28\u91cf\u4e00\u81f4\u6027\uff0c\u662f\u4e00\u81f4\u6027\u8bc4\u4ef7\u5de5\u7a0b\u7684\u5ef6\u4f38\u3002\u53ea\u6709\u8fd9\u6837\u624d\u80fd\u771f\u6b63\u4f53\u73b0\u4e00\u81f4\u6027\u8bc4\u4ef7\u5de5\u7a0b\u7684\u610f\u4e49\u3002\u622a\u81f3<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2018<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5e74<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">6<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6708\u5e95\uff0c\u8054\u4e9a\u836f\u4e1a\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">4<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u79cd\u5242\u91cf\u89c4\u683c\u5df2\u7d2f\u8ba1\u6210\u529f\u751f\u4ea7\u8d85\u8fc7\u767e\u6279\u3002\u7814\u53d1\u8fc7\u7a0b\u4e2d\u8054\u4e9a\u836f\u4e1a\u5145\u5206\u5e94\u7528<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">QbD<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7406\u5ff5\u8fdb\u884c\u4ea7\u54c1\u5f00\u53d1\uff0c\u5e76\u5efa\u7acb\u4e86\u6709\u6548\u7684\u8fc7\u7a0b\u63a7\u5236\uff0c\u4e3a\u672c\u4ea7\u54c1\u7684\u957f\u671f\u6210\u529f\u5546\u4e1a\u5316\u751f\u4ea7\u5960\u5b9a\u4e86\u575a\u5b9e\u7684\u57fa\u7840\u3002\u4e3b\u8981\u8868\u73b0\u4e3a\u4ee5\u4e0b\u51e0\u70b9\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZDHTK--GBK1-0;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">6.1 \u826f\u597d\u7684\u4ea7\u54c1\u5747\u5300\u6027<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">6.1.1<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">\u6df7\u5408\u5747\u5300\u6027<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8054\u4e9a\u836f\u4e1a\u5df2\u751f\u4ea7\u7684\u8d85\u8fc7\u767e\u6279\u5546\u4e1a\u5316\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u7ec8\u6df7\u7269<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">BU<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6837\u54c1\u542b\u91cf\u5e73\u5747\u503c\u5728<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">97.2% ~ 101.4%<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e4b\u95f4\uff0c\u5355\u503c\u5728<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">93.9% ~ 105.1%<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e4b\u95f4\uff0c\u5404\u6279<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">RSD<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6700\u5927\u503c\u4e3a<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">1.7%<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff0c\u6279\u5185\u4e0e\u6279\u95f4\u5747\u5300\u6027\u90fd\u975e\u5e38\u7a33\u5b9a\uff0c\u80fd\u591f\u5f88\u597d\u5730\u6ee1\u8db3<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">BU<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7684\u8981\u6c42\uff08\u89c1\u56fe<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">3<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;text-align: center;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><img class=\"\"       style=\"box-sizing: border-box !important;word-wrap: break-word !important;width: 592px !important;visibility: visible !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/2-1544149449.jpg\" alt=\"\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u4e13\u5bb6\u4ee5FDA\u6279\u51c6\u7684\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e3a\u4f8b\u8c08\u9ad8\u7aef\u53e3\u670d\u56fa\u4f53\u7f13\u63a7\u91ca\u5236\u5242\u5f00\u53d1\" title=\"\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u4e13\u5bb6\u4ee5FDA\u6279\u51c6\u7684\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e3a\u4f8b\u8c08\u9ad8\u7aef\u53e3\u670d\u56fa\u4f53\u7f13\u63a7\u91ca\u5236\u5242\u5f00\u53d1\"><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">6.1.2<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">\u542b\u91cf\u5747\u5300\u6027<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8054\u4e9a\u836f\u4e1a\u5df2\u751f\u4ea7\u7684\u8d85\u8fc7\u767e\u6279\u5546\u4e1a\u5316\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u6240\u6d4b\u5f97\u5355\u7247<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">CU<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7ed3\u679c\u90fd\u5728<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">93.8% ~103.7%<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e4b\u95f4\uff0c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">99.9%CI<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5355\u4fa7\u6781\u503c\u5206\u522b\u4e3a\uff1a\u6700\u5c0f<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">CU<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5355\u503c\u4e3a<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">93.5%<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3001 \u6700\u5927<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">CU<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5355\u503c\u4e3a<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">104.7%<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3002\u6240\u6709\u6279\u6b21\u5e73\u5747<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">AV<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e3a<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2.6<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff0c\u6807\u51c6\u5dee\uff08<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">SD<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u4e3a<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">0.9%<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff0c\u6700\u5927<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">AV<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e3a<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">5.1<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff08\u73b0\u6709<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">USP&lt;905&gt;<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8981\u6c42\u4e3a\u2264<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">15.0<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u3002\u4ee5\u76ee\u524d<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">USP&lt;905&gt;<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8fb9\u754c\u53ef\u63a5\u53d7\u503c\u7684\u6700\u5927<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">AV<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e3a<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">15<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8ba1\u7b97\uff0c\u672c\u4ea7\u54c1<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">AV<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7684\u8fc7\u7a0b\u80fd\u529b\u6307\u6570\uff08<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">process capability index<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff0c<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">CpK<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09 \u5927\u4e8e<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">4<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff0c \u8fdc\u8fdc\u6ee1\u8db3<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">6\u03c3<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7684\u8981\u6c42\uff0c\u57fa\u672c\u4e0d\u53ef\u80fd\u51fa\u73b0<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">AV<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8d85\u51fa\u8303\u56f4\u7684\u60c5\u51b5\uff08\u89c1\u56fe<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">4<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u3002\u8fd9\u4e9b\u7ed3\u679c\u5747\u663e\u793a\u8054\u4e9a\u836f\u4e1a\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u5728\u5e38\u89c4\u5546\u4e1a\u5316\u751f\u4ea7\u4e2d\u542b\u91cf\u5747\u5300\u5ea6\u98ce\u9669\u975e\u5e38\u4f4e\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZDHTK--GBK1-0;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">6.2 \u957f\u671f\u5546\u4e1a\u5316\u751f\u4ea7\u6279\u6b21\u6eb6\u51fa\u4e00\u81f4\u6027<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u53e3\u670d\u56fa\u4f53\u4eff\u5236\u5236\u5242\u7684\u8bc4\u5224\u5e94\u8be5\u662f\u4ee5<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">BE<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e3a\u9996\u8981\u524d\u63d0\uff0c\u517c\u987e\u6eb6\u51fa\u5ea6\u3002\u5728\u5b9e\u73b0<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">BE<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u524d\u6eb6\u51fa\u5ea6\u53ef\u4ee5\u6709\u53d8\u52a8\u7684\u81ea\u7531\u5ea6\u3002\u4f46\u662f\u4e00\u65e6\u4ea7\u54c1\u5b9e\u73b0<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">BE<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff0c\u540e\u7eed\u653e\u5927\u548c\u5546\u4e1a\u5316\u6279\u6b21\u7684\u6eb6\u51fa\u5ea6\u5c31\u5e94\u8be5\u4e0e<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">BE<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6279\u6b21\u4fdd\u6301\u4e00\u81f4\uff0c\u6210\u4e3a\u4ea7\u54c1\u8d28\u91cf\u63a7\u5236\u7684\u4e00\u9879\u6709\u56fa\u5b9a\u6307\u6807\u7684\u5e38\u89c4\u68c0\u6d4b\u9879\u3002\u5230\u76ee\u524d\u4e3a\u6b62\uff0c\u8054\u4e9a\u836f\u4e1a\u6240\u6709\u7684\u5546\u4e1a\u5316\u751f\u4ea7\u6279\u6b21\u4e0d\u540c\u5242\u91cf\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u6eb6\u51fa\u5ea6\u4e0e<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">BE<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6279\u6b21\u5747\u4fdd\u6301\u9ad8\u5ea6\u4e00\u81f4\uff0c\u8868\u660e\u8054\u4e9a\u836f\u4e1a\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u8d28\u91cf\u7a33\u5b9a\u4e14\u53ef\u63a7\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;text-align: center;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><img class=\"\"       style=\"box-sizing: border-box !important;word-wrap: break-word !important;width: 592px !important;visibility: visible !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/1-1544149450.jpg\" alt=\"\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u4e13\u5bb6\u4ee5FDA\u6279\u51c6\u7684\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e3a\u4f8b\u8c08\u9ad8\u7aef\u53e3\u670d\u56fa\u4f53\u7f13\u63a7\u91ca\u5236\u5242\u5f00\u53d1\" title=\"\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u4e13\u5bb6\u4ee5FDA\u6279\u51c6\u7684\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e3a\u4f8b\u8c08\u9ad8\u7aef\u53e3\u670d\u56fa\u4f53\u7f13\u63a7\u91ca\u5236\u5242\u5f00\u53d1\"><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 21px;font-family: FZDHTK--GBK1-0;color: rgb(255, 128, 0);box-sizing: border-box !important;word-wrap: break-word !important;\">7 \u7ed3\u8bed<\/span><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5bf9\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u7684\u6279\u51c6\uff0c\u4ee5\u53ca\u6b64\u4ea7\u54c1\u7684\u957f\u671f\u6210\u529f\u5546\u4e1a\u5316\u751f\u4ea7\uff0c\u6807\u5fd7\u7740\u6211\u516c\u53f8\u5df2\u7ecf\u89e3\u51b3\u4e86\u8be5\u4ea7\u54c1\u6240\u6709\u7684\u6280\u672f\u96be\u9898\uff0c\u53ef\u4e25\u683c\u63a7\u5236\u5e76\u4fdd\u8bc1\u4ea7\u54c1\u7684<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">2<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e2a\u4e00\u81f4\u6027\uff0c\u5373\u4e0e\u539f\u7814\u836f\u7684\u8d28\u91cf\u548c\u7597\u6548\u4e00\u81f4\u6027\uff0c\u4ee5\u53ca\u957f\u671f\u5546\u4e1a\u5316\u751f\u4ea7\u6279\u6b21\u4e0e<\/span><span style=\"max-width: 100%;font-size: 15px;font-family: TimesNewRomanPSMT, serif;box-sizing: border-box !important;word-wrap: break-word !important;\">BE<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;font-size: 15px;font-family: FZSSK--GBK1-0;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6279\u6b21\u95f4\u7684\u8d28\u91cf\u4e00\u81f4\u6027\u3002\u672c\u6587\u4ee5\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u4e3a\u4f8b\uff0c\u7b80\u5355\u4ecb\u7ecd\u4e86\u6b64\u4ea7\u54c1\u7684\u5f00\u53d1\u96be\u70b9\u53ca\u5ba1\u8bc4\u8981\u6c42\uff0c\u4f9b\u4ece\u4e8b\u6b64\u7c7b\u9ad8\u7aef\u4eff\u5236\u836f\u7269\u5236\u5242\u7684\u5f00\u53d1\u53ca\u5ba1\u8bc4\u5de5\u4f5c\u7684\u4eba\u58eb\u53c2\u8003\u3002\u968f\u7740\u6211\u56fd\u836f\u54c1\u76d1\u7ba1\u5236\u5ea6\u7684\u4e00\u7cfb\u5217\u6539\u9769\uff0c\u5728\u76ee\u524d\u56fd\u5bb6\u9f13\u52b1\u521b\u65b0\u7684\u533b\u836f\u5927\u73af\u5883\u4e0b\uff0c\u53ef\u4ee5\u76f8\u4fe1\uff0c\u4e0d\u4e45\u7684\u5c06\u6765\uff0c\u5728\u4e2d\u56fd\u5e02\u573a\u4e0a\u4f1a\u6709\u8d8a\u6765\u8d8a\u591a\u7684\u9ad8\u7aef\u5236\u5242\u60e0\u53ca\u4e2d\u56fd\u767e\u59d3\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><\/p>\n<section class=\"\" style=\"padding-right: 4px;padding-left: 4px;max-width: 100%;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;border-width: 1px;border-style: dashed;border-color: rgb(255, 102, 0);background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\n<section style=\"margin-top: 5px;margin-bottom: 5px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\n<section style=\"margin: 5px auto;max-width: 100%;border-width: initial;border-style: none;border-color: initial;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span class=\"\" style=\"padding-right: 30px;padding-left: 30px;max-width: 100%;display: block;color: rgb(255, 255, 255);background: rgb(255, 129, 36);box-sizing: border-box !important;word-wrap: break-word !important;\"><\/p>\n<section class=\"\" style=\"padding-right: 10px;padding-left: 10px;max-width: 100%;height: 30px;line-height: 30px;display: inline-block;color: rgb(255, 129, 36);border-color: rgb(255, 129, 36);background: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\n<p style=\"max-width: 100%;min-height: 1em;white-space: pre-wrap;border-color: rgb(255, 129, 36);box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5173\u4e8e\u5357\u901a\u8054\u4e9a<\/strong><\/p>\n<\/section>\n<p><\/span><\/section>\n<\/section>\n<\/section>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;text-indent: 28px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;overflow-wrap: break-word !important;\"><strong style=\"max-width: 100%;letter-spacing: 0.544px;font-size: 16px;line-height: 25.6px;color: rgb(255, 169, 0);white-space: pre-wrap;box-sizing: border-box !important;word-wrap: break-word !important;overflow-wrap: break-word !important;\">\u25cf <\/strong><span style=\"max-width: 100%;font-size: 14px;text-align: left;text-indent: 28px;font-family: \u5fae\u8f6f\u96c5\u9ed1, sans-serif;color: black;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5357\u901a\u8054\u4e9a\u836f\u4e1a\uff08Novast\uff09\u4e8e2006\u5e74\u5728\u5357\u901a\u7efc\u5408\u4fdd\u7a0e\u533a\u6210\u7acb\u540e\u6b63\u5f0f\u8fd0\u8425\uff0c\u662f\u4e00\u4e2a\u4ee5\u9ad8\u65b0\u79d1\u6280\u4e3a\u57fa\u7840\u7684\u3001\u4e13\u6ce8\u4e8e\u7279\u6b8a\u836f\u54c1\u7684\u8de8\u56fd\u5236\u836f\u516c\u53f8\uff0c\u76ee\u524d\u62e5\u6709\u5728\u804c\u5458\u5de5480\u4f59\u4eba\uff0c\u751f\u4ea7\u5382\u623f\u8d85\u8fc75\u4e07\u5e73\u7c73\uff0c\u4ea7\u80fd50\u4ebf\u5355\u4f4d\u3002Novast\u62e5\u6709\u4e00\u652f\u975e\u5e38\u4f18\u79c0\u548c\u5b8c\u6574\u7684\u56fd\u9645\u5316\u6280\u672f\u7ba1\u7406\u56e2\u961f\u548c\u671d\u6c14\u84ec\u52c3\u7684\u5458\u5de5\u961f\u4f0d\u3002\u591a\u5e74\u6765\uff0c\u51ed\u501f\u4f18\u79c0\u7684\u7ba1\u7406\u6280\u672f\u56e2\u961f\u3001\u5148\u8fdb\u7684\u5236\u5242\u6280\u672f\u5e73\u53f0\u3001\u8d28\u91cf\u81f3\u4e0a\u7684\u516c\u53f8\u6587\u5316\u548c\u5b8c\u6574\u7684cGMP\u7ba1\u7406\u4f53\u7cfb\u3001\u4ee5\u53ca\u5bf9\u89c4\u8303\u5e02\u573a\u7684\u4e30\u5bcc\u7ecf\u9a8c\uff0c\u8054\u4e9a\u836f\u4e1a\u5df2\u4e0e\u5168\u7403\u591a\u5bb6\u5927\u578b\u836f\u4f01\u5efa\u7acb\u4e86\u957f\u671f\u5408\u4f5c\u4f19\u4f34\u5173\u7cfb\uff0c\u4e3a\u4ed6\u4eec\u63d0\u4f9b\u5168\u65b9\u4f4d\u3001\u4e00\u7ad9\u5f0fCRO\u548cCMO\u7684\u56fd\u9645\u6280\u672f\u5916\u5305\u670d\u52a1\u3002\u4e1a\u52a1\u8303\u56f4\u6db5\u76d6\u4e86\u4ea7\u54c1\u7684\u5408\u4f5c\u5f00\u53d1\uff0c\u5e02\u573a\u56ca\u62ec\u4e86\u7f8e\u56fd\u548c\u65b0\u5174\u56fd\u5bb6\u7684\u5904\u65b9\u836f\u7269\u5e02\u573a\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-indent: 28px;line-height: 27px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 14px;font-family: \u5fae\u8f6f\u96c5\u9ed1, sans-serif;color: black;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u5df2\u6210\u529f\u5411\u7f8e\u56fdFDA\u9012\u4ea4\u4e86\u8fd150\u4e2a\u9ad8\u7aef\u4eff\u5236\u836f\u7269\u5236\u5242\u7684\u7533\u8bf7\uff0c\u5176\u4e2d30\u4e2a\u4e0d\u540c\u5236\u5242\u4ea7\u54c1\u5df2\u7ecf\u83b7\u5f97\u7f8e\u56fdFDA\u7684\u6700\u7ec8\u6279\u51c6\uff0c\u5176\u4e2d\u5305\u62ec6\u4e2a\u7f13\u91ca\u4ea7\u54c1\uff08\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u3001\u785d\u82ef\u5730\u5e73\u7f13\u91ca\u7247\u3001\u5432\u54da\u7f8e\u8f9b\u7f13\u91ca\u80f6\u56ca\u3001\u4e59\u9170\u5511\u80fa\u7f13\u91ca\u80f6\u56ca\u3001\u5bcc\u9a6c\u9178\u55b9\u786b\u5e73\u7f13\u91ca\u7247\u3001\u76d0\u9178\u4e8c\u7532\u53cc\u80cd\u7f13\u91ca\u7247\uff09\u3002\u81ea2012\u5e74\u4ee5\u6765\uff0cNovast\u5df2\u8ba9\u4e2d\u56fd\u201c\u667a\u9020\u201d\u5e76\u6709\u81ea\u4e3b\u54c1\u724c\u7684\u836f\u7269\u5236\u5242\u9646\u7eed\u6210\u529f\u767b\u9646\u7f8e\u56fd\u5904\u65b9\u836f\u7269\u7684\u4e3b\u6d41\u5e02\u573a\u3002\u76ee\u524d\uff0c\u8054\u4e9a\u836f\u4e1a\u7425\u73c0\u9178\u7f8e\u6258\u6d1b\u5c14\u7f13\u91ca\u7247\u7f8e\u56fd\u5e02\u573a\u5360\u6709\u7387\u83b7\u9760\u524d\u6392\u540d\u3002Novast\u81ea2008\u20142018\u5e74\u5df2\u8fde\u7eed5\u6b21\u4ee5483\u96f6\u7f3a\u9677\u901a\u8fc7\u7f8e\u56fdFDA\u7684cGMP\u73b0\u573a\u68c0\u67e5\u3002\u76ee\u524d\uff0c\u5357\u901a\u8054\u4e9a\u836f\u4e1a\u6b63\u5728\u628a\u7531\u56fd\u5185\u7814\u53d1\u751f\u4ea7\uff0cFDA\u6279\u51c6\u8fdb\u5165\u7f8e\u56fd\u5904\u65b9\u836f\u7269\u5e02\u573a\u7684\u9ad8\u7aef\u5236\u5242\u9646\u7eed\u5411\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u9012\u4ea4\u6ce8\u518c\u7533\u8bf7\uff0c\u5c06\u4e3a\u56fd\u5185\u5e02\u573a\u63d0\u4f9b\u9ad8\u8d28\u91cf\u7684\u836f\u7269\u5236\u5242\u4ea7\u54c1\uff0c\u5176\u4e2d\u5305\u62ec\u591a\u4e2a\u56fd\u5185\u9996\u4eff\u836f\u7269\u5236\u5242\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-indent: 28px;line-height: 27px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 14px;font-family: \u5fae\u8f6f\u96c5\u9ed1, sans-serif;color: black;box-sizing: border-box !important;word-wrap: break-word 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