{"id":41788,"date":"2018-08-15T01:00:00","date_gmt":"2018-09-17T06:55:51","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/09\/17\/%e7%94%b3%e6%8a%a5%e8%b5%84%e6%96%99%e4%b8%ad%e5%8e%9f%e6%96%99%e8%8d%af%e7%89%b9%e6%80%a7%e9%89%b4%e5%ae%9a%e9%83%a8%e5%88%86%e7%9a%84%e8%a7%a3%e8%af%bb-%e5%9f%b9%e4%bc%98%e7%b2%be\/"},"modified":"2018-09-17T14:55:52","modified_gmt":"2018-09-17T06:55:52","slug":"%e7%94%b3%e6%8a%a5%e8%b5%84%e6%96%99%e4%b8%ad%e5%8e%9f%e6%96%99%e8%8d%af%e7%89%b9%e6%80%a7%e9%89%b4%e5%ae%9a%e9%83%a8%e5%88%86%e7%9a%84%e8%a7%a3%e8%af%bb-%e5%9f%b9%e4%bc%98%e7%b2%be","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/41788\/","title":{"rendered":"\u7533\u62a5\u8d44\u6599\u4e2d\u539f\u6599\u836f\u7279\u6027\u9274\u5b9a\u90e8\u5206\u7684\u89e3\u8bfb\u2014\u2014\u57f9\u4f18\u7cbe\u9009|\u539f\u8f85\u5305\u7cfb\u521713"},"content":{"rendered":"<div class=\"bpp-post-content\">\n<section class=\"\" style=\"white-space: normal;max-width: 100%;color: rgb(51, 51, 51);\">\n<section style=\"margin-right: auto;margin-left: auto;max-width: 100%;box-sizing: border-box;border-width: 2px;border-style: solid;border-color: rgb(200, 233, 252);border-radius: 25px;background: rgb(247, 252, 254);word-wrap: break-word !important;\">\n<section  style=\"margin: 5px auto;max-width: 100%;width: 403.797px;overflow: hidden;box-sizing: border-box !important;word-wrap: break-word !important;\"><img class=\"\"      style=\"margin-right: auto;margin-left: auto;display: block;box-sizing: border-box !important;word-wrap: break-word !important;visibility: visible !important;width: 403.797px !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/09\/8-1537167352.png\" alt=\"\u7533\u62a5\u8d44\u6599\u4e2d\u539f\u6599\u836f\u7279\u6027\u9274\u5b9a\u90e8\u5206\u7684\u89e3\u8bfb\u2014\u2014\u57f9\u4f18\u7cbe\u9009|\u539f\u8f85\u5305\u7cfb\u521713\" title=\"\u7533\u62a5\u8d44\u6599\u4e2d\u539f\u6599\u836f\u7279\u6027\u9274\u5b9a\u90e8\u5206\u7684\u89e3\u8bfb\u2014\u2014\u57f9\u4f18\u7cbe\u9009|\u539f\u8f85\u5305\u7cfb\u521713\"  \/><\/section>\n<section style=\"margin-top: -15px;padding: 1em;max-width: 100%;box-sizing: border-box;font-size: 14px;letter-spacing: 1.5px;line-height: 1.75em;color: rgb(63, 62, 63);word-wrap: break-word !important;\">\n<p style=\"max-width: 100%;min-height: 1em;text-align: center;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 16px;color: rgb(0, 128, 255);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;\">\u4f1a\u8bae\u901a\u77e5<\/strong><\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5efa\u7acbFDA\u8ba4\u53ef\u7684\u7814\u53d1\u548c\u751f\u4ea7\u6d41\u7a0b\u662f\u6210\u529f\u7684\u5173\u952e\u4e4b\u6240\u5728\uff0c\u800c\u719f\u6089\u7f8e\u56fd\u7684\u6cd5\u89c4\u548c\u6ce8\u518c\u6d41\u7a0b\u53ef\u4ee5\u8ba9\u6211\u4eec\u7684\u5de5\u4f5c\u4e8b\u534a\u529f\u500d\uff01\u672c\u6b21\u4f1a\u8bae\uff0c\u6211\u4eec\u5c06\u5bf9MAH\u5236\u5ea6\u3001\u6539\u826f\u521b\u65b0\u4e2d\u7f8e\u53cc\u62a5\u4f5c\u91cd\u70b9\u4ecb\u7ecd\uff0c\u5bf9\u60a8\u6240\u5173\u6ce8\u7684\u95ee\u9898\u8fdb\u884c\u91cd\u70b9\u89e3\u7b54\u3002\u671f\u5f85\u5e7f\u5927\u670b\u53cb\u7684\u5149\u4e34\u3002<\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><a href=\"http:\/\/mp.weixin.qq.com\/s?__biz=MzI3MzUwNTM2MA==&amp;mid=2247489274&amp;idx=2&amp;sn=c4c3672d00b4556281c67e0ad3ecdaba&amp;chksm=eb231bc5dc5492d3184f678a3291bfe89157d35345516586fdf5dc844551a730e27ddcfce631&amp;scene=21#wechat_redirect\" target=\"_blank\" style=\"color: rgb(255, 169, 0);text-decoration: underline;-webkit-tap-highlight-color: rgba(0, 0, 0, 0);max-width: 100%;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;\">\u4f1a\u8bae\u94fe\u63a5\uff1a9\u67086\u65e5-\u6539\u826f\u521b\u65b0\u7684\u4e2d\u7f8e\u53cc\u62a5\u7b56\u7565\u4e0eMAH\u5173\u952e\u95ee\u9898\u7814\u8ba8\u4f1a<\/strong><\/a><\/p>\n<\/section>\n<\/section>\n<\/section>\n<p style=\"white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><br  \/><\/p>\n<section style=\"padding: 5px;max-width: 100%;box-sizing: border-box;\">\n<section style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;border-radius: 50%;border-width: 3px;border-style: solid;border-color: rgb(55, 74, 174);width: 1.8em;height: 1.8em;text-align: center;color: rgb(55, 74, 174);font-family: inherit;font-size: 1.6em;font-weight: inherit;text-decoration: inherit;vertical-align: top;display: inline-block;background: rgb(254, 254, 254);word-wrap: break-word !important;\">\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;line-height: 1.6em;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 18px;box-sizing: border-box !important;word-wrap: break-word !important;\">1<\/span><\/section>\n<\/section>\n<\/section>\n<section class=\"\" style=\"margin-top: -1.56em;margin-bottom: 1em;margin-left: 0.5em;max-width: 100%;box-sizing: border-box;border-color: rgb(55, 74, 174);border-radius: 1em;color: rgb(255, 255, 255);font-family: inherit;font-size: 1.2em;font-weight: inherit;text-decoration: inherit;float: left;z-index: -1;background-color: rgb(55, 74, 174);word-wrap: break-word !important;\"><span style=\"margin-right: 5px;margin-left: 5px;padding-right: 10px;padding-left: 2em;max-width: 100%;box-sizing: border-box;line-height: 1.6em;font-family: inherit;font-size: 16px;vertical-align: top;float: left;display: inline-block;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u539f\u6599\u836f\u7279\u6027\u9274\u522b\u90e8\u5206\u7684\u6a21\u5757\u7ec4\u6210<\/strong><\/span><\/section>\n<\/section>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><span style=\"font-size: 14px;\">CTD \u683c\u5f0f\u7533\u62a5\u8d44\u6599\u4e2d3.2.S.3 \u7ae0\u8282\u4e3a\u7279\u6027\u9274\u5b9a\u90e8\u5206\uff0c\u5305\u62ec\u201c3.2.S.3.1 \u7ed3\u6784\u548c\u7406\u5316\u6027\u8d28\u201d\u3001\u201c3.2.S.3.2 \u6742\u8d28\u201d \u4e24\u4e2a\u6a21\u5757\uff0c\u5176\u4e2d\uff0c\u201c3.2.S.3.1\u7ed3\u6784\u548c\u7406\u5316\u6027\u8d28\u201d\u5305\u62ec\u4e86 \u201c( 1) \u7ed3\u6784\u786e\u8bc1\u201d\u3001\u201c( 2) \u7406\u5316\u6027\u8d28\u201d\u4e24\u90e8\u5206\u5185\u5bb9\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><span style=\"font-size: 14px;\">&nbsp;<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><span style=\"font-size: 14px;\">( 1) &#8220;\u7ed3\u6784\u786e\u8bc1\u201d \u5bf9\u5e94\u4e8e2007 \u5e74\u7248\u300a\u836f\u54c1\u6ce8\u518c\u7ba1\u7406\u529e\u6cd5\u300b\u9644\u4ef62 \u683c\u5f0f\u7533\u62a5\u8d44\u6599\u76849 \u53f7\u8d44\u6599;&nbsp;( 2) &#8220;\u7406\u5316\u6027\u8d28\u201d\u3001\u201c3.2.S.3.2 \u6742\u8d28\u201d\u5728\u539f\u6ce8\u518c\u7ba1\u7406\u529e\u6cd5\u9644\u4ef62 \u683c\u5f0f\u76848 \u53f7\u300110 \u53f7\u8d44\u6599\u4e2d\u5747\u6709\u63d0\u53ca\uff0c\u4f46\u90fd\u6bd4\u8f83\u5206\u6563\uff0cCTD \u683c\u5f0f\u4e0b\u5728\u6b64\u90e8\u5206\u4e13\u95e8\u5217\u51fa\u4e86\u7ae0\u8282\uff0c\u8981\u6c42\u5bf9\u5176\u8fdb\u884c\u5168\u9762\u9610\u8ff0\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><br  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><span style=\"font-size: 14px;\">\u4e0b\u9762\u6309\u6a21\u5757\u5bf9\u7279\u6027\u9274\u5b9a\u7684\u64b0\u5199\u8981\u6c42\u53ca\u76f8\u5173\u7814\u7a76\u6280\u672f\u8981\u6c42\u8fdb\u884c\u89e3\u8bfb\u5206\u6790\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><span style=\"font-size: 14px;\">&nbsp;<\/span><\/p>\n<section style=\"padding: 5px;max-width: 100%;box-sizing: border-box;\">\n<section style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;border-radius: 50%;border-width: 3px;border-style: solid;border-color: rgb(55, 74, 174);width: 1.8em;height: 1.8em;text-align: center;color: rgb(55, 74, 174);font-family: inherit;font-size: 1.6em;font-weight: inherit;text-decoration: inherit;vertical-align: top;display: inline-block;background: rgb(254, 254, 254);word-wrap: break-word !important;\">\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;line-height: 1.6em;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 18px;box-sizing: border-box !important;word-wrap: break-word !important;\">2<\/span><\/section>\n<\/section>\n<\/section>\n<section class=\"\" style=\"margin-top: -1.56em;margin-bottom: 1em;margin-left: 0.5em;max-width: 100%;box-sizing: border-box;border-color: rgb(55, 74, 174);border-radius: 1em;color: rgb(255, 255, 255);font-family: inherit;font-size: 1.2em;font-weight: inherit;text-decoration: inherit;float: left;z-index: -1;background-color: rgb(55, 74, 174);word-wrap: break-word !important;\"><span style=\"margin-right: 5px;margin-left: 5px;padding-right: 10px;padding-left: 2em;max-width: 100%;box-sizing: border-box;line-height: 1.6em;font-family: inherit;font-size: 16px;vertical-align: top;float: left;display: inline-block;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u201c3.2.S.3.1\u7ed3\u6784\u548c\u7406\u5316\u6027\u8d28\u201d\u6a21\u5757\u7684\u89e3\u8bfb<\/strong><\/span><\/section>\n<\/section>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">2.1 \u7ed3\u6784\u786e\u8bc1<\/strong><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\">&nbsp;<\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><span style=\"font-size: 14px;\">\u7ed3\u6784\u786e\u8bc1\u662f\u9a8c\u8bc1\u7533\u62a5\u7684\u5236\u5907\u5de5\u827a\u4e0b\u4ea7\u54c1\u7ed3\u6784\u7684\u6b63\u786e\u4e0e\u5426\uff0c\u4fdd\u8bc1\u6574\u4e2a\u7814\u7a76\u5de5\u4f5c\u7269\u8d28\u57fa\u7840\u7684\u6b63\u786e\u6027\u3002\u5bf9\u4e8e\u591a\u6570\u5c0f\u5206\u5b50\u836f\u7269\uff0c\u7ed3\u6784\u786e\u8bc1\u4e00\u822c\u662f\u4ece\u5143\u7d20\u7ec4\u6210\u3001\u5e73\u9762\u7ed3\u6784\u3001\u7acb\u4f53\u7ed3\u6784\u3001\u6676\u578b\u7b49\u65b9\u9762\u6765\u9610\u8ff0\u4ea7\u54c1\u7684\u7ed3\u6784\u3002\u5e38\u7528\u7684\u7814\u7a76\u624b\u6bb5\u6709\u5f88\u591a\uff0c<span style=\"max-width: 100%;color: rgb(0, 82, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u4f8b\u5982\uff0c\u5143\u7d20\u5206\u6790\u3001\u9ad8\u5206\u8fa8\u8d28\u8c31\u7528\u4e8e\u786e\u8bc1\u5143\u7d20\u7ec4\u6210; UV\u3001I\uff32\u3001NM\uff32\u3001MS\u3001\u6bd4\u65cb\u5ea6\u3001\u5355\u6676X-\u884d\u5c04\u3001\u5706\u4e8c\u8272\u8c31\u7b49\u7528\u4e8e\u7ed3\u6784\u7814\u7a76; \u7c89\u672bX-\u884d\u5c04\u3001\u62c9\u66fc\u5149\u8c31\u3001\u7194\u70b9\u3001\u70ed\u5206\u6790\u7b49\u7528\u4e8e\u6676\u578b\u7814\u7a76\u3002<\/span><\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><span style=\"font-size: 14px;\">&nbsp;<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><span style=\"font-size: 14px;\">\u9700\u8981\u6ce8\u610f\u7684\u662f\uff0c\u7814\u7a76\u624b\u6bb5\u662f\u591a\u79cd\u591a\u6837\u7684\uff0c\u4f46\u5e94\u7528\u5230\u5177\u4f53\u4ea7\u54c1\u7684\u65f6\u5019\uff0c\u9700\u8981\u6839\u636e\u836f\u7269\u7684\u7ed3\u6784\u7279\u5f81\u3001\u7ed3\u5408\u5df2\u6709\u4fe1\u606f( \u5982\u6587\u732e\u62a5\u9053\u3001\u5236\u5907\u5de5\u827a\u3001\u5bf9\u7167\u54c1\u7b49) \uff0c\u5408\u7406\u5236\u5b9a\u7814\u7a76\u65b9\u6848\u3002\u4f8b\u5982\uff0c\u5bf9\u4e8e\u5408\u6210\u591a\u80bd\u836f\u7269\uff0c\u5e38\u89c4\u7684I\uff32\uff0cUV\uff0cNM\uff32 \u7b49\u7814\u7a76\u624b\u6bb5\u80fd\u63d0\u4f9b\u7684\u7ed3\u6784\u4fe1\u606f\u6bd4\u8f83\u6709\u9650\uff0c\u591a\u80bd\u836f\u7269\u7684\u6c28\u57fa\u9178\u7ec4\u6210\u3001\u5e8f\u5217\u7b49\u4e00\u7ea7\u7ed3\u6784\u7684\u4fe1\u606f\u662f\u91cd\u8981\u7814\u7a76\u5185\u5bb9\uff0cEdman \u964d\u89e3\u3001\u57fa\u4e8e\u591a\u79cd\u6280\u672f\u7684\u8d28\u8c31\u65b9\u6cd5\u662f\u6709\u6548\u7684\u7814\u7a76\u624b\u6bb5\uff0c\u5bf9\u4e8e\u957f\u80bd\uff0c\u8fd8\u53ef\u80fd\u5b58\u5728\u7a7a\u95f4\u7ed3\u6784\u7684\u786e\u8bc1\u7814\u7a76\u95ee\u9898\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><span style=\"font-size: 14px;\">&nbsp;<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><span style=\"font-size: 14px;\">\u53e6\u5916\uff0c\u5bf9\u4e8e\u591a\u7ec4\u5206\u836f\u7269\uff0c\u4f8b\u5982\u7f9f\u4e59\u57fa\u6dc0\u7c89\u7c7b\u4ea7\u54c1\uff0c\u5b83\u662f\u4e00\u7cfb\u5217\u4e0d\u540c\u5206\u5b50\u91cf\u4ea7\u54c1\u7ec4\u6210\u7684\u6df7\u5408\u7269\uff0c\u91c7\u7528\u5e38\u89c4\u624b\u6bb5\u65e0\u6cd5\u76f4\u63a5\u786e\u8bc1\u5176\u7ed3\u6784\uff0c\u5efa\u8bae\u53ef\u4ece\u4ea7\u54c1\u7684\u5206\u5b50\u91cf\u4e0e\u5206\u5b50\u91cf\u5206\u5e03\u3001\u7279\u6027\u7c98\u5ea6\u3001\u6469\u5c14\u53d6\u4ee3\u5ea6\u3001\u53d6\u4ee3\u65b9\u5f0f( C2 \/C6) \u7b49\u65b9\u9762\u8fdb\u884c\u7814\u7a76\u8bf4\u660e\uff0c\u5bf9\u4e8e\u4eff\u5236\u836f\uff0c\u8fd8\u53ef\u4e0e\u539f\u7814\u5236\u5242\u4ea7\u54c1\u8fdb\u884c\u5bf9\u6bd4\u7814\u7a76\uff0c\u91cd\u70b9\u7814\u7a76\u8bf4\u660e\u5404\u7ec4\u5206\u7684\u7ec4\u6210\u3001\u6bd4\u4f8b\u4e0e\u539f\u7814\u4ea7\u54c1\u4e00\u81f4\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><span style=\"font-size: 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style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><span style=\"font-size: 14px;\">&nbsp;<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><span style=\"font-size: 14px;\">\u7814\u7a76\u7528\u6837\u54c1\u8fd8\u5e94\u8be5\u5177\u6709\u4e00\u5b9a\u7684\u7eaf\u5ea6\uff0c\u4ee5\u514d\u6742\u8d28\u7684\u5b58\u5728\u5e72\u6270\u7ed3\u6784\u7684\u89e3\u6790\u3002\u5982\u7ed3\u6784\u786e\u8bc1\u7814\u7a76\u4e2d\u4f7f\u7528\u4e86\u5bf9\u7167\u54c1\uff0c\u5e94\u8bf4\u660e\u5bf9\u7167\u54c1\u7684\u6765\u6e90\u3001\u7eaf\u5ea6\u53ca\u6279\u53f7\u7b49\u4fe1\u606f\u3002\u7acb\u4f53\u7ed3\u6784\u548c\u6676\u578b\u662f\u5ba1\u8bc4\u5de5\u4f5c\u4e2d\u53d1\u73b0\u5b58\u5728\u95ee\u9898\u8f83\u591a\u7684\u4e24\u4e2a\u7814\u7a76\u9879\u76ee\uff0c\u4e0b\u9762\u5bf9\u7acb\u4f53\u7ed3\u6784\u3001\u6676\u578b\u7684\u7814\u7a76\u65b9\u6cd5\u548c\u7814\u7a76\u601d\u8def\u8fdb\u4e00\u6b65\u8ba8\u8bba\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><span style=\"font-size: 14px;\">&nbsp;<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><span style=\"font-size: 14px;\">\u5bf9\u4e8e\u591a\u624b\u6027\u4e2d\u5fc3\u836f\u7269\u7684\u7acb\u4f53\u7ed3\u6784\u786e\u8bc1\uff0c\u5355\u6676X-\u884d\u5c04\u662f\u4e00\u79cd\u8f83\u76f4\u63a5\u7684\u7814\u7a76\u624b\u6bb5\uff0c\u4f46\u6709\u4e9b\u4ea7\u54c1\u7684\u5355\u6676\u5236\u5907\u6bd4\u8f83\u56f0\u96be\uff0c\u5f88\u591a\u65f6\u5019\u4e5f\u6ca1\u6709\u5fc5\u8981\uff0c\u53ef\u91c7\u7528\u4e8c\u7ef4\u6838\u78c1\u3001\u5706\u4e8c\u8272\u8c31\u3001\u65cb\u5149\u5149\u8c31\u7b49\u65b9\u6cd5\uff0c\u7ed3\u5408\u624b\u6027\u4e2d\u5fc3\u7684\u5f15\u5165\u65b9\u5f0f( \u4f8b\u5982\u8d77\u59cb\u539f\u6599\u5f15\u5165\u624b\u6027\u4e2d\u5fc3\u7684\u7acb\u4f53\u6784\u578b\u5df2\u786e\u8bc1) \uff0c\u5229\u7528\u5316\u5b66\u53cd\u5e94\u7684\u7acb\u4f53\u9009\u62e9\u6027\u3001\u624b\u6027HPLC 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14px;\">\u6b64\u5916\uff0c\u4e0d\u540c\u6676\u578b\u56e0\u5316\u5b66\u53cd\u5e94\u6027\u3001\u5f15\u6e7f\u6027\u7684\u5dee\u5f02\uff0c\u6216\u56e0\u8f6c\u6676\uff0c\u53ef\u80fd\u4f1a\u5f71\u54cd\u5230\u5236\u5242\u7684\u7a33\u5b9a\u6027\u3002\u56e0\u6b64\u539f\u6599\u836f\u7684\u6676\u578b\u662f\u4ea7\u54c1\u5f00\u53d1\u8fc7\u7a0b\u4e2d\u4e0d\u53ef\u5ffd\u89c6\u7684\u4e00\u9879\u7814\u7a76\u5185\u5bb9\u3002<span style=\"font-size: 14px;max-width: 100%;color: rgb(0, 82, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u6676\u578b\u7684\u7814\u7a76\u624b\u6bb5\u5305\u62ec\u7c89\u672bX-\u884d\u5c04( X\uff32PD) 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Q6A\u4e2d\u7684\u6676\u578b\u7814\u7a76\u51b3\u7b56\u6811\u3002\u5728\u521b\u65b0\u836f\u7684\u65e9\u671f\u7814\u53d1\u9636\u6bb5\uff0c\u6676\u578b\u7814\u7a76\u7684\u9996\u8981\u5de5\u4f5c\u662f\u591a\u6676\u578b\u7684\u7b5b\u9009\u4ee5\u53ca\u6676\u578b\u7684\u9009\u62e9\uff0c\u8981\u6839\u636e\u5404\u6676\u578b\u4e4b\u95f4\u70ed\u529b\u5b66\u7a33\u5b9a\u6027\u5173\u7cfb\u7684\u8bc4\u4f30\u6765\u8003\u8651\u6676\u578b\u7684\u9009\u62e9\uff0c\u901a\u5e38\u662f\u9009\u62e9\u70ed\u529b\u5b66\u7a33\u5b9a\u7684\u6676\u578b\uff0c\u4ee5\u964d\u4f4e\u6676\u578b\u8f6c\u53d8\u7684\u98ce\u9669\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><span style=\"font-size: 14px;\">&nbsp;<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><span style=\"font-size: 14px;\">\u5bf9\u4e8e\u4eff\u5236\u836f\uff0c\u5982\u4e3a\u96be\u6eb6\u6027\u53e3\u670d\u56fa\u4f53\u836f\u7269\uff0c\u4e14\u5b58\u5728\u591a\u6676\u578b\u7684\u95ee\u9898\uff0c\u5efa\u8bae\u53c2\u8003\u4ee5\u4e0b\u7814\u7a76\u601d\u8def: \u9996\u5148\u9700\u8c03\u7814\u5206\u6790\u539f\u7814\u4ea7\u54c1\u91c7\u7528\u7684\u6676\u578b\u60c5\u51b5\uff0c\u5982\u539f\u7814\u6676\u578b\u672a\u77e5\uff0c\u5219\u53ef\u53c2\u8003ICH Q6A \u4e2d\u6676\u578b\u51b3\u7b56\u6811\u7684\u7814\u7a76\u601d\u8def; 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\u5305\u62ec\u5236\u5242\u5de5\u827a\u6761\u4ef6\u4e0b\u7684\u7a33\u5b9a\u6027) \u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><br style=\"max-width: 100%;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;\">2.2&nbsp;\u7406\u5316\u6027\u8d28<\/strong><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\">&nbsp;<\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><span style=\"font-size: 14px;\">\u8be5\u90e8\u5206\u8bf7\u63d0\u4f9b\u539f\u6599\u836f\u8be6\u7ec6\u7684\u7406\u5316\u6027\u8d28\u4fe1\u606f\uff0c\u5305\u62ec:<span style=\"max-width: 100%;color: rgb(0, 82, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;\u6027\u72b6( \u5982\u5916\u89c2\u3001\u989c\u8272\u3001\u7269\u7406\u72b6\u6001) \uff0c\u7194\u70b9\/\u6cb8\u70b9\uff0c\u6bd4\u65cb\u5ea6\uff0c\u6eb6\u89e3\u6027\uff0c\u5438\u6e7f\u6027\uff0c\u6eb6\u6db2pH\uff0c\u5206\u914d\u7cfb\u6570\uff0c\u89e3\u79bb\u5e38\u6570\uff0c\u5c06\u7528\u4e8e\u5236\u5242\u751f\u4ea7\u7684\u7269\u7406\u5f62\u6001( \u5982\u591a\u6676\u578b\u3001\u6eb6\u5242\u5316\u7269\u6216\u6c34\u5408\u7269) \u3001\u7c92\u5ea6<\/span>\u7b49\u3002\u5bf9\u4e8e\u6eb6\u89e3\u6027\uff0c\u4e0d\u4ec5\u63d0\u4f9b\u4e0d\u540c\u4ecb\u8d28\u4e2d\u7684\u6eb6\u89e3\u5ea6\u60c5\u51b5\uff0c\u66f4\u8981\u5173\u6ce8\u5728\u4e0d\u540cpH \u6c34\u4e2d\u7684\u6eb6\u89e3\u5ea6\u60c5\u51b5\u3002\u8d44\u6599\u4e2d\u5e94\u6ce8\u660e\u6570\u636e\u7684\u6587\u732e\u6765\u6e90\uff0c\u81ea\u884c\u6d4b\u5b9a\u7684\u9879\u76ee\uff0c\u5e94\u8bf4\u660e\u5177\u4f53\u7684\u6d4b\u5b9a\u65b9\u6cd5\u3002\u5efa\u8bae\u7279\u522b\u5173\u6ce8\u4e0e\u5236\u5242\u751f\u4ea7\u3001\u6027\u80fd\u76f8\u5173\u7684\u91cd\u8981\u4fe1\u606f\uff0c\u5982\u6eb6\u89e3\u6027\u3001\u6676\u578b\u3001\u7c92\u5ea6\u3001\u5f15\u6e7f\u6027\u7b49\u3002\u5efa\u8bae\u5c3d\u91cf\u63d0\u4f9b\u6e17\u900f\u6027\u7684\u6570\u636e\uff0c\u4ee5\u7528\u4e8e\u8bc4\u4f30\u751f\u7269\u836f\u5242\u5b66\u5206\u7c7b\uff0c\u5e2e\u52a9\u5236\u5242\u7684\u5904\u65b9\u5de5\u827a\u5f00\u53d1\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\">&nbsp;<\/p>\n<section style=\"padding: 5px;max-width: 100%;box-sizing: border-box;\">\n<section style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;border-radius: 50%;border-width: 3px;border-style: solid;border-color: rgb(55, 74, 174);width: 1.8em;height: 1.8em;text-align: center;color: rgb(55, 74, 174);font-family: inherit;font-size: 1.6em;font-weight: inherit;text-decoration: inherit;vertical-align: top;display: inline-block;background: rgb(254, 254, 254);word-wrap: break-word !important;\">\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;line-height: 1.6em;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 18px;box-sizing: border-box !important;word-wrap: break-word !important;\">3<\/span><\/section>\n<\/section>\n<\/section>\n<section class=\"\" style=\"margin-top: -1.56em;margin-bottom: 1em;margin-left: 0.5em;max-width: 100%;box-sizing: border-box;border-color: rgb(55, 74, 174);border-radius: 1em;color: rgb(255, 255, 255);font-family: inherit;font-size: 1.2em;font-weight: inherit;text-decoration: inherit;float: left;z-index: -1;background-color: rgb(55, 74, 174);word-wrap: break-word !important;\"><span style=\"margin-right: 5px;margin-left: 5px;padding-right: 10px;padding-left: 2em;max-width: 100%;box-sizing: border-box;line-height: 1.6em;font-family: inherit;font-size: 16px;vertical-align: top;float: left;display: inline-block;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u201c 3.2.S.3.2\u6742\u8d28\u201d\u6a21\u5757\u7684\u89e3\u8bfb<\/strong><\/span><\/section>\n<\/section>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><span style=\"font-size: 14px;\">\u6742\u8d28\u4f5c\u4e3a\u836f\u7269\u7684\u4e00\u9879\u5173\u952e\u8d28\u91cf\u5c5e\u6027\uff0c\u662f\u7814\u53d1\u5de5\u4f5c\u7684\u91cd\u8981\u5185\u5bb9\u4e4b\u4e00\u3002\u7279\u6027\u9274\u5b9a\u4e2d\u6b64\u90e8\u5206\u662f\u5bf9\u539f\u6599\u836f\u6742\u8d28\u8c31\u7684\u5168\u9762\u5206\u6790\uff0c\u4e0d\u6d89\u53ca\u68c0\u67e5\u65b9\u6cd5\u7684\u7814\u7a76\u53ca\u9a8c\u8bc1\u7684\u5185\u5bb9\u3002\u901a\u8fc7\u5168\u9762\u7684\u6742\u8d28\u8c31\u5206\u6790\uff0c\u53ef\u6307\u5f15\u539f\u6599\u836f\u5236\u5907\u5de5\u827a\u7684\u5f00\u53d1\u548c\u4f18\u5316\u3001\u8d28\u91cf\u63a7\u5236\u7b56\u7565\u7684\u5236\u5b9a; \u53ef\u4f7f\u6742\u8d28\u68c0\u67e5\u5de5\u4f5c\u6709\u7684\u653e\u77e2\uff0c\u6839\u636e\u4e0d\u540c\u6742\u8d28\u7684\u7279\u6027\u6765\u9488\u5bf9\u6027\u7684\u5efa\u7acb\u68c0\u67e5\u65b9\u6cd5\uff0c\u6709\u52a9\u4e8e\u68c0\u67e5\u65b9\u6cd5\u7684\u5efa\u7acb\u548c\u9a8c\u8bc1\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><span style=\"font-size: 14px;\">&nbsp;<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><span style=\"font-size: 14px;\">\u6309\u7406\u5316\u6027\u8d28\u901a\u5e38\u5c06\u6742\u8d28\u5206\u4e3a3 \u7c7b: \u6709\u673a\u6742\u8d28\u3001\u65e0\u673a\u6742\u8d28\u3001\u6b8b\u7559\u6eb6\u5242\u3002\u63a8\u8350\u91c7\u7528\u8868\u683c( \u89c1\u88681) \u7684\u5f62\u5f0f\u6765\u5448\u73b0\u6742\u8d28\u5206\u6790\u7684\u7ed3\u679c\uff0c\u5728\u8868\u683c\u4e2d\u9700\u8981\u8bf4\u660e\u6742\u8d28\u7684\u540d\u79f0\u3001\u5df2\u9274\u5b9a\u6742\u8d28\u7684\u7ed3\u6784\u3001\u5206\u6790\u6742\u8d28\u7684\u4ea7\u751f\u6765\u6e90\u3001\u8bf4\u660e\u662f\u5426\u8ba2\u5165\u6807\u51c6\u4ee5\u53ca\u63a7\u5236\u9650\u5ea6\u3002\u5efa\u8bae\u5728\u8be5\u90e8\u5206\u8d44\u6599\u4e2d\u8bf4\u660e\u5404\u6742\u8d28\u7684\u8d28\u63a7\u7b56\u7565( \u6e90\u5934\u63a7\u5236\u3001\u8fc7\u7a0b\u63a7\u5236\u3001\u7ec8\u4ea7\u54c1\u6807\u51c6\u63a7\u5236) \uff0c\u8ba8\u8bba\u8bf4\u660e\u8d28\u63a7\u7b56\u7565\u7684\u5408\u7406\u6027\u3001\u6742\u8d28\u9650\u5ea6\u5236\u5b9a\u7684\u4f9d\u636e\u3002\u5ba1\u8bc4\u5de5\u4f5c\u4e2d\u53d1\u73b0\u5b58\u5728\u8f83\u591a\u7684\u95ee\u9898\u662f\u6742\u8d28\u8c31\u5206\u6790\u8fc7\u4e8e\u7b80\u5355\uff0c\u4ec5\u5173\u6ce8\u8d77\u59cb\u539f\u6599\u548c\u4e2d\u95f4\u4f53\uff0c\u6216\u4ec5\u7b80\u5355\u7f57\u5217\u8d28\u91cf\u6807\u51c6\u4e2d\u5df2\u63a7\u5236\u7684\u7279\u5b9a\u6742\u8d28\uff0c\u5efa\u8bae\u5bf9\u539f\u6599\u836f\u4e2d\u5b9e\u9645\u5b58\u5728\u6742\u8d28\u548c\u6f5c\u5728\u6742\u8d28\u5747\u8fdb\u884c\u5206\u6790\u8ba8\u8bba\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><img class=\"\"       style=\"box-sizing: border-box !important;word-wrap: break-word !important;width: 526px !important;visibility: visible !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/09\/5-1537167352.jpeg\" alt=\"\u7533\u62a5\u8d44\u6599\u4e2d\u539f\u6599\u836f\u7279\u6027\u9274\u5b9a\u90e8\u5206\u7684\u89e3\u8bfb\u2014\u2014\u57f9\u4f18\u7cbe\u9009|\u539f\u8f85\u5305\u7cfb\u521713\" title=\"\u7533\u62a5\u8d44\u6599\u4e2d\u539f\u6599\u836f\u7279\u6027\u9274\u5b9a\u90e8\u5206\u7684\u89e3\u8bfb\u2014\u2014\u57f9\u4f18\u7cbe\u9009|\u539f\u8f85\u5305\u7cfb\u521713\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">3.1 \u6709\u673a\u6742\u8d28&nbsp;<\/strong><span class=\"Apple-converted-space\">&nbsp;<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><br  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><span style=\"font-size: 14px;\">\u6309\u6709\u673a\u6742\u8d28\u4ea7\u751f\u7684\u6765\u6e90\u4e0d\u540c\uff0c\u53ef\u5206\u4e3a\u5de5\u827a\u6742\u8d28\u3001\u964d\u89e3\u4ea7\u7269\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><span style=\"font-size: 14px;\">&nbsp;<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><span style=\"font-size: 14px;\">\u5de5\u827a\u6742\u8d28\u5305\u62ec: \u5408\u6210\u539f\u6599\uff0c\u4e2d\u95f4\u4f53\uff0c\u53cd\u5e94\u8bd5\u5242\uff0c\u5408\u6210\u539f\u6599\u5f15\u5165\u7684\u6742\u8d28\u53ca\u5176\u540e\u7eed\u53cd\u5e94\u4ea7\u7269\uff0c\u526f\u53cd\u5e94\u4ea7\u7269\u53ca\u5176\u540e\u7eed\u53cd\u5e94\u4ea7\u7269\uff0c\u7b49\u7b49\u3002\u5de5\u827a\u6742\u8d28\u7684\u5206\u6790\u8981\u57fa\u4e8e\u5de5\u827a\u5f00\u53d1\u8fc7\u7a0b\u4e2d\u77e5\u8bc6\u548c\u6570\u636e\u7684\u79ef\u7d2f\uff0c\u4ee5\u53ca\u5bf9\u5236\u5907\u5de5\u827a\u7684\u6df1\u5165\u7406\u89e3\uff0c\u8981\u6ce8\u610f\u5206\u6790\u8ba8\u8bba\u6742\u8d28\u7684\u5f62\u6210\u3001\u53bb\u5411\/\u6e05\u9664\u60c5\u51b5\uff0c\u5efa\u8bae\u91cd\u70b9\u5173\u6ce8\u4e0e\u4e3b\u6210\u5206\u7ed3\u6784\u7c7b\u4f3c\u3001\u53ef\u968f\u4e3b\u6210\u5206\u4e00\u540c\u8fdb\u884c\u540e\u7eed\u53cd\u5e94\u7684\u5de5\u827a\u6742\u8d28\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><span style=\"font-size: 14px;\">&nbsp;<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><span style=\"font-size: 14px;\">\u4e3a\u8bf4\u660e\u5de5\u827a\u6742\u8d28\u8d28\u63a7\u7b56\u7565\u7684\u5408\u7406\u6027\uff0c\u5efa\u8bae\u6309\u5de5\u827a\u8def\u7ebf\u7684\u987a\u5e8f\u5206\u522b\u8ba8\u8bba\u8d77\u59cb\u539f\u6599\u3001\u4e2d\u95f4\u4f53\u3001\u7c97\u54c1\u53ca\u7ec8\u4ea7\u54c1\u7684\u5de5\u827a\u6742\u8d28\u60c5\u51b5\uff0c\u5217\u51fa\u6570\u636e\u79ef\u7d2f\u60c5\u51b5\uff0c\u5206\u6790\u8ba8\u8bba\u5404\u6b65\u9aa4\u4e2d\u6742\u8d28\u7684\u53bb\u5411\/\u6e05\u9664\u60c5\u51b5\uff0c\u5c06\u8fc7\u7a0b\u63a7\u5236\u4e0e\u7ec8\u70b9\u63a7\u5236\u6709\u673a\u7ed3\u5408\uff0c\u5168\u9762\u7cfb\u7edf\u7684\u63a7\u5236\u836f\u54c1\u8d28\u91cf\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><span style=\"font-size: 14px;\">&nbsp;<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><span style=\"font-size: 14px;\">\u5bf9\u4e8e\u964d\u89e3\u6742\u8d28\uff0c\u53ef\u901a\u8fc7\u7ed3\u6784\u7279\u5f81\u7684\u5206\u6790\u4ee5\u53ca\u8bd5\u9a8c\u7684\u624b\u6bb5\u6765\u7814\u7a76\u6f5c\u5728\u7684\u964d\u89e3\u9014\u5f84\u548c\u964d\u89e3\u4ea7\u7269\uff0c\u7a33\u5b9a\u6027\u8bd5\u9a8c\u3001\u5f3a\u5236\u964d\u89e3\u8bd5\u9a8c\u662f\u5e38\u7528\u7684\u8bd5\u9a8c\u624b\u6bb5\u3002\u76f8\u5bf9\u4e8e\u7a33\u5b9a\u6027\u8bd5\u9a8c\uff0c\u5f3a\u5236\u964d\u89e3\u8bd5\u9a8c\u53ef\u5728\u8f83\u77ed\u7684\u65f6\u95f4\u5185\u83b7\u5f97\u5927\u91cf\u7684\u6709\u76ca\u4fe1\u606f\uff0c\u56e0\u6b64\u5728\u65e9\u671f\u7814\u53d1\u9636\u6bb5\uff0c\u5f3a\u5236\u964d\u89e3\u8bd5\u9a8c\u662f\u7814\u7a76\u6f5c\u5728\u964d\u89e3\u9014\u5f84\u548c\u964d\u89e3\u4ea7\u7269\u7684\u4e00\u79cd\u6709\u6548\u624b\u6bb5\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><span style=\"font-size: 14px;\">&nbsp;<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 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style=\"font-size: 14px;\">\u6b64\u5916\uff0c\u8fd8\u8bf7\u5173\u6ce8\u5bf9\u6f5c\u5728\u9057\u4f20\u6bd2\u6027\u6742\u8d28\u7684\u5206\u6790\u3002\u7531\u4e8e\u5b89\u5168\u6027\u7684\u62c5\u5fe7\uff0c\u56fd\u5185\u5916\u76d1\u7ba1\u673a\u6784\u5bf9\u6b64\u7c7b\u6742\u8d28\u90fd\u8868\u73b0\u51fa\u5f88\u9ad8\u7684\u5173\u6ce8\u5ea6\uff0c\u6b27\u76df\u3001FDA\u3001ICH\u5148\u540e\u53d1\u5e03\u4e86\u9057\u4f20\u6bd2\u6027\u6742\u8d28\u7814\u7a76\u7684\u6307\u5bfc\u539f\u5219\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><br style=\"max-width: 100%;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;\">3.2 \u65e0\u673a\u6742\u8d28&nbsp;<\/strong><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\">&nbsp;<\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><span style=\"font-size: 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