{"id":4692,"date":"2018-06-23T01:00:00","date_gmt":"2018-07-27T06:54:56","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/07\/27\/%e5%8c%96%e5%ad%a6%e4%bb%bf%e5%88%b6%e8%8d%af%e6%b3%a8%e5%86%8c%e6%89%b9%e7%94%9f%e4%ba%a7%e8%a7%84%e6%a8%a1%e7%9a%84%e4%b8%80%e8%88%ac%e6%80%a7%e6%8a%80%e6%9c%af%e8%a6%81%e6%b1%82%ef%bc%88%e8%af%95\/"},"modified":"2018-07-27T14:54:57","modified_gmt":"2018-07-27T06:54:57","slug":"%e5%8c%96%e5%ad%a6%e4%bb%bf%e5%88%b6%e8%8d%af%e6%b3%a8%e5%86%8c%e6%89%b9%e7%94%9f%e4%ba%a7%e8%a7%84%e6%a8%a1%e7%9a%84%e4%b8%80%e8%88%ac%e6%80%a7%e6%8a%80%e6%9c%af%e8%a6%81%e6%b1%82%ef%bc%88%e8%af%95","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/4692\/","title":{"rendered":"\u5316\u5b66\u4eff\u5236\u836f\u6ce8\u518c\u6279\u751f\u4ea7\u89c4\u6a21\u7684\u4e00\u822c\u6027\u6280\u672f\u8981\u6c42\uff08\u8bd5\u884c\uff09"},"content":{"rendered":"<div class=\"bpp-post-content\">\n<p><img class=\"\"       style=\"\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/07\/beepress2-1532674497.jpg\" alt=\"\u5316\u5b66\u4eff\u5236\u836f\u6ce8\u518c\u6279\u751f\u4ea7\u89c4\u6a21\u7684\u4e00\u822c\u6027\u6280\u672f\u8981\u6c42\uff08\u8bd5\u884c\uff09\" title=\"\u5316\u5b66\u4eff\u5236\u836f\u6ce8\u518c\u6279\u751f\u4ea7\u89c4\u6a21\u7684\u4e00\u822c\u6027\u6280\u672f\u8981\u6c42\uff08\u8bd5\u884c\uff09\"><\/p>\n<p style=\"text-align: center;\">\n<p style=\"text-align: center;\"><span style=\"font-size: 15px;\">\u5316\u5b66\u4eff\u5236\u836f\u6ce8\u518c\u6279\u751f\u4ea7\u89c4\u6a21\u7684\u4e00\u822c\u6027\u8981\u6c42\uff08\u8bd5\u884c\uff09<\/span><\/p>\n<p><span style=\"font-size: 15px;\">&nbsp;<\/span><\/p>\n<p><span style=\"font-size: 15px;\">\u4e3a\u8fdb\u4e00\u6b65\u8d2f\u5f7b\u4e2d\u5171\u4e2d\u592e\u529e\u516c\u5385\u3001\u56fd\u52a1\u9662\u529e\u516c\u5385\u300a\u5173\u4e8e\u6df1\u5316\u5ba1\u8bc4\u5ba1\u6279\u5236\u5ea6\u6539\u9769\u9f13\u52b1\u836f\u54c1\u533b\u7597\u5668\u68b0\u521b\u65b0\u7684\u610f\u89c1\u300b\uff08\u5385\u5b57\u30142017\u301542\u53f7\uff09\u7cbe\u795e\uff0c\u63a8\u52a8\u836f\u54c1\u6ce8\u518c\u6280\u672f\u6807\u51c6\u56fd\u9645\u63a5\u8f68\uff0c\u4fc3\u8fdb\u4eff\u5236\u836f\u7814\u53d1\u548c\u751f\u4ea7\u6c34\u5e73\u7684\u63d0\u5347\uff0c\u6211\u4e2d\u5fc3\u7ed3\u5408\u56fd\u9645\u76f8\u5173\u6280\u672f\u6307\u5357\u4ee5\u53ca\u6211\u56fd\u4eff\u5236\u836f\u751f\u4ea7\u7684\u73b0\u72b6\uff0c\u7279\u5236\u5b9a\u5316\u5b66\u836f\u54c1\u4eff\u5236\u836f\u6ce8\u518c\u6279\u751f\u4ea7\u89c4\u6a21\u7684\u4e00\u822c\u6027\u8981\u6c42\u3002<\/span><\/p>\n<p><br  \/><\/p>\n<p><span style=\"font-size: 15px;color: rgb(255, 41, 65);\">\u6ce8\u518c\u6279\u662f\u6307\u80fd\u591f\u4ee3\u8868\u62df\u5b9a\u7684\u5546\u4e1a\u5316\u751f\u4ea7\u5de5\u827a\u751f\u4ea7\u5e76\u7528\u4e8e\u6ce8\u518c\u7533\u62a5\u7684\u6279\u6b21\uff0c\u5176\u4ea7\u54c1\u8d28\u91cf\u987b\u4e0e\u5546\u4e1a\u5316\u751f\u4ea7\u4ea7\u54c1\u4e00\u81f4\u3002\u4e00\u822c\u60c5\u51b5\u4e0b\uff0c\u7528\u4e8e\u6b63\u5f0f\u7a33\u5b9a\u6027\u7814\u7a76\u7684\u6279\u6b21\u53ef\u4f5c\u4e3a\u6ce8\u518c\u6279\uff0c\u6ce8\u518c\u6279\u7684\u751f\u4ea7\u4e0e\u62df\u5546\u4e1a\u5316\u751f\u4ea7\u7684\u751f\u4ea7\u573a\u5730\uff08\u5177\u4f53\u81f3\u751f\u4ea7\u7ebf\uff09\u548c\u8bbe\u5907\u539f\u7406\u5e94\u4fdd\u6301\u4e00\u81f4\u3002<\/span><span style=\"font-size: 15px;\">\u4e0d\u540c\u5236\u5242\u7c7b\u578b\u7684\u5177\u4f53\u8981\u6c42\u5982\u4e0b\uff1a&nbsp;<\/span><\/p>\n<p><span style=\"font-size: 15px;\"><br  \/><\/span><\/p>\n<p><span style=\"font-size: 15px;\">1.\u53e3\u670d\u5236\u5242\uff1a\uff081\uff09\u666e\u901a\u7247\u5242\/\u80f6\u56ca\u5242\uff08\u5982\u901f\u91ca\u7247\u5242\u6216\u80f6\u56ca\u5242\u7b49\uff09\uff1a\u6ce8\u518c\u6279\u4e09\u6279\u5747\u5e94\u81f3\u5c11\u8fbe\u5230\u62df\u5b9a\u5546\u4e1a\u5316\u751f\u4ea7\u89c4\u6a21\u768410%\u6216100,000\u5236\u5242\u5355\u4f4d\uff0c\u4e24\u8005\u4e2d\u9009\u66f4\u591a\u7684\u3002\uff082\uff09\u6563\u5242\/\u6eb6\u6db2\u5242\/\u6df7\u60ac\u5242\/\u9897\u7c92\u5242\/\u7cd6\u6d46\u5242\uff1a\u6ce8\u518c\u6279\u4e09\u6279\u5747\u5e94\u81f3\u5c11\u8fbe\u5230\u62df\u5b9a\u5546\u4e1a\u5316\u751f\u4ea7\u89c4\u6a21\u768410%\u3002\uff083\uff09\u7f13\u63a7\u91ca\u7247\u5242\/\u80f6\u56ca\uff1a\u6ce8\u518c\u6279\u4e09\u6279\u5747\u5e94\u8be5\u81f3\u5c11\u8fbe\u5230100,000\u5236\u5242\u5355\u4f4d\uff0c\u5efa\u8bae\u6ce8\u518c\u6279\u751f\u4ea7\u89c4\u6a21\u4e0e\u62df\u5b9a\u5546\u4e1a\u5316\u751f\u4ea7\u89c4\u6a21\u4e00\u81f4\u3002<\/span><\/p>\n<p><span style=\"font-size: 15px;\"><br  \/><\/span><\/p>\n<p><span style=\"font-size: 15px;\">2.\u6ce8\u5c04\u5242\/\u5c40\u90e8\u7528\u65e0\u83cc\u5236\u5242\uff08\u773c\u7528\u548c\u8033\u7528\u5236\u5242\uff09\uff1a\u6ce8\u518c\u6279\u4e09\u6279\u4e2d\u7684\u4e24\u4e2a\u6279\u6b21\u5e94\u81f3\u5c11\u8fbe\u5230\uff081\uff09\u62df\u5b9a\u5546\u4e1a\u5316\u751f\u4ea7\u89c4\u6a21\u768410%\uff1b\u6216\uff082\uff09\u5982\u679c\u6bcf\u74f6\/\u652f\u7684\u704c\u88c5\u91cf\u5927\u4e8e2.0ml\uff0c\u5219\u4e3a50L\/\u6279\uff0c\u5982\u679c\u704c\u88c5\u91cf\u4e0d\u8d85\u8fc72.0ml\uff0c\u5219\u4e3a30L\/\u6279\uff1b\u4e0a\u8ff0\uff081\uff09\u6216\uff082\uff09\u5e94\u9009\u62e9\u6279\u91cf\u66f4\u5927\u7684\uff08\u5305\u88c5\u540e\uff09\u3002\u7533\u8bf7\u4eba\u7533\u62a5\u591a\u79cd\u704c\u88c5\u89c4\u683c\uff08\u59821 mL\u30012 mL\u548c3 mL\uff09\u65f6\uff0c\u5efa\u8bae\u6279\u91cf\u5e94\u81f3\u5c11\u8fbe\u523050L\u3002\u7b2c\u4e09\u4e2a\u6279\u6b21\u53ef\u4ee5\u4f4e\u4e8e\u62df\u5b9a\u5546\u4e1a\u5316\u751f\u4ea7\u89c4\u6a21\u768410%\uff0c\u4f46\u5e94\u81f3\u5c11\u8fbe\u5230\u6ce8\u518c\u6279\u6700\u5927\u6279\u91cf\u768425%\uff08\u5305\u88c5\u540e\uff09\u3002<\/span><\/p>\n<p><span style=\"font-size: 15px;\"><br  \/><\/span><\/p>\n<p><span style=\"font-size: 15px;\">3.\u7279\u6b8a\u6ce8\u5c04\u5242\uff08\u5982\u8102\u8d28\u4f53\u3001\u5fae\u7403\u3001\u80f6\u675f\u7b49\uff09\/\u5438\u5165\u6c14\u96fe\u5242\/\u5438\u5165\u7c89\u96fe\u5242\uff1a\u5efa\u8bae\u6ce8\u518c\u6279\u751f\u4ea7\u89c4\u6a21\u4e0e\u62df\u5b9a\u5546\u4e1a\u5316\u751f\u4ea7\u89c4\u6a21\u4e00\u81f4\u3002<\/span><\/p>\n<p><span style=\"font-size: 15px;\"><br  \/><\/span><\/p>\n<p><span style=\"font-size: 15px;\">4.\u900f\u76ae\u8d34\u5242\uff1a\u6ce8\u518c\u6279\u4e09\u6279\u5747\u5e94\u81f3\u5c11\u8fbe\u5230\u62df\u5b9a\u5546\u4e1a\u5316\u751f\u4ea7\u89c4\u6a21\u768410%\uff08\u5305\u88c5\u540e\uff09\uff0c\u6216\u800525,000\u4e2a\u5236\u5242\u5355\u4f4d\uff08\u6bcf\u79cd\u89c4\u683c\uff09\uff0c\u4e24\u8005\u4e2d\u9009\u66f4\u591a\u7684\u3002\u5bf9\u4e8e\u9aa8\u67b6\u578b\u4ea7\u54c1\uff0c\u4ee5\u900f\u76ae\u8d34\u7247\u5927\u5c0f\uff08\u8868\u9762\u79ef\uff09\u6765\u786e\u5b9a\u4e0d\u540c\u89c4\u683c\u65f6\uff0c\u5efa\u8bae\u7533\u62a5\u65f6\u63d0\u4ea4\u91c7\u7528\u4e09\u6279\u9aa8\u67b6\u5c42\u751f\u4ea7\u7684\u8d34\u7247\u7814\u7a76\u6570\u636e\u3002<\/span><\/p>\n<p><span style=\"font-size: 15px;\"><br  \/><\/span><\/p>\n<p><span style=\"font-size: 15px;\">5.\u4e73\u818f\u5242\/\u8f6f\u818f\u5242\/\u51dd\u80f6\u5242\/\u6813\u5242\uff1a\u5bf9\u4e8e\u975e\u65e0\u83cc\u5236\u5242\uff0c\u6ce8\u518c\u6279\u4e09\u6279\u5747\u5e94\u81f3\u5c11\u8fbe\u5230100kg\u6216\u8005\u62df\u5b9a\u5546\u4e1a\u5316\u751f\u4ea7\u89c4\u6a21\u768410%\uff0c\u4e24\u8005\u4e2d\u9009\u66f4\u591a\u7684\uff08\u5305\u88c5\u540e\uff09\u3002<\/span><\/p>\n<p><span style=\"font-size: 15px;\"><br  \/><\/span><\/p>\n<p><span style=\"font-size: 15px;\">6.\u5176\u4ed6\uff1a\u5bf9\u4e8e\u672c\u6587\u672a\u6d89\u53ca\u7684\u5176\u4ed6\u5236\u5242\u7c7b\u578b\uff0c\u5176\u4eff\u5236\u836f\u6ce8\u518c\u6279\u751f\u4ea7\u89c4\u6a21\u53ef\u53c2\u7167\u76f8\u5173\u56fd\u9645\u901a\u884c\u6280\u672f\u6307\u5357\u6267\u884c\u3002\u5bf9\u4e8e\u4ee5\u4e0b\u60c5\u51b5\uff0c\u5176\u4eff\u5236\u836f\u6ce8\u518c\u6279\u751f\u4ea7\u89c4\u6a21\u53ef\u4f4e\u4e8e\u4e0a\u8ff0\u8981\u6c42\uff1a\uff081\uff09\u7ecf\u56fd\u5bb6\u76f8\u5173\u90e8\u95e8\u786e\u5b9a\u4e3a\u7528\u4e8e\u7f55\u89c1\u75c5\u6cbb\u7597\u7684\u836f\u7269\u5236\u5242\uff1b\uff082\uff09\u6309\u56fd\u5bb6\u89c4\u5b9a\u8fdb\u884c\u7ba1\u5236\u7684\u836f\u7269\u5236\u5242\u3002<\/span><\/p>\n<p><span style=\"font-size: 15px;\"><br  \/><\/span><\/p>\n<p><span style=\"font-size: 15px;\">\u5982\u6709\u5176\u5b83\u7279\u6b8a\u539f\u56e0\uff08\u5546\u4e1a\u56e0\u7d20\u9664\u5916\uff09\u65e0\u6cd5\u6ee1\u8db3\u4e0a\u8ff0\u57fa\u672c\u8981\u6c42\u7684\uff0c\u5efa\u8bae\u7533\u62a5\u524d\u4e0e\u76d1\u7ba1\u673a\u6784\u8fdb\u884c\u6c9f\u901a\u3002<\/span><\/p>\n<p><span style=\"font-size: 15px;\">&nbsp;<\/span><\/p>\n<p><span style=\"font-size: 15px;\">\u53c2\u8003\u6587\u732e\uff1a<\/span><\/p>\n<p><span style=\"font-size: 12px;\">1.ICH&nbsp;Q1A(R2): Stability Testing of NewDrug Substances and Products. February, 2003.<\/span><\/p>\n<p><span style=\"font-size: 12px;\">2.\u5316\u5b66\u836f\u7269\uff08\u539f\u6599\u836f\u548c\u5236\u5242\uff09\u7a33\u5b9a\u6027\u7814\u7a76\u6280\u672f\u6307\u5bfc\u539f\u5219\uff08\u4fee\u8ba2\uff09\u3002<\/span><\/p>\n<p><span style=\"font-size: 12px;\">3.\u4e2d\u56fd\u836f\u5178\uff082015\u5e74\u7248\u56db\u90e8\u6307\u5bfc\u539f\u52199011\uff09\uff1a\u836f\u7269\u5236\u5242\u4eba\u4f53\u751f\u7269\u5229\u7528\u5ea6\u548c\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u6307\u5bfc\u539f\u5219\u3002<\/span><\/p>\n<p><span style=\"font-size: 12px;\">4.&nbsp;FDA (May 2014), Guidance forIndustry ANDAs Stability Testing of Drug Substances and Products Questions andAnswers.<\/span><\/p>\n<p><span style=\"font-size: 12px;\">5.WHO Technical Report Series, No. 953,2009. Annex 2 Stability testing of active pharmaceutical ingredients andfinished pharmaceutical products.<\/span><\/p>\n<p><span style=\"font-size: 12px;\">6.\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40. \u5173\u4e8e\u53d1\u5e03\u5316\u5b66\u836f\u54c1\u65b0\u6ce8\u518c\u5206\u7c7b\u7533\u62a5\u8d44\u6599\u8981\u6c42\uff08\u8bd5\u884c\uff09\u7684\u901a\u544a\uff082016\u5e74\u7b2c80\u53f7\uff09\u3002<\/span><\/p>\n<p><span style=\"font-size: 15px;\">&nbsp;<\/span><\/p>\n<\/p>\n<p><span style=\"font-size: 15px;\"><\/span><br  \/><\/p>\n<p><br  \/><\/p>\n<blockquote class='keep-source'>\n<p>\u59cb\u53d1\u4e8e\u5fae\u4fe1\u516c\u4f17\u53f7\uff1a                         \u7cfb\u7edf                      <\/p>\n<\/blockquote>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u5316\u5b66\u4eff\u5236\u836f\u6ce8\u518c\u6279\u751f\u4ea7\u89c4\u6a21\u7684\u4e00\u822c\u6027\u8981\u6c42\uff08\u8bd5\u884c\uff09 &nbsp; \u4e3a\u8fdb\u4e00\u6b65\u8d2f\u5f7b\u4e2d\u5171\u4e2d\u592e\u529e\u516c\u5385\u3001\u56fd\u52a1\u9662\u529e\u516c\u5385\u300a\u5173\u4e8e\u6df1\u5316 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":4693,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/4692"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=4692"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/4692\/revisions"}],"predecessor-version":[{"id":4695,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/4692\/revisions\/4695"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/4693"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=4692"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=4692"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=4692"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}