{"id":81218,"date":"2019-04-05T00:00:50","date_gmt":"2019-04-11T06:47:38","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/81218\/"},"modified":"2019-04-11T14:47:42","modified_gmt":"2019-04-11T06:47:42","slug":"eac6e6ad16","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/81218\/","title":{"rendered":"\u884c\u4e1a\u4fe1\u606f|2019\u5e743\u6708\u533b\u836f\u653f\u7b56\u6c47\u7f16"},"content":{"rendered":"
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 \u4eff\u5236\u836f\u4e00\u81f4\u6027\u8bc4\u4ef7<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u5173\u4e8e\u53d1\u5e03\u5316\u5b66\u4eff\u5236\u836f\u53c2\u6bd4\u5236\u5242\u9074\u9009\u4e0e\u786e\u5b9a\u7a0b\u5e8f\u7684\u516c\u544a\uff082019\u5e74\u7b2c25\u53f7\uff09<\/strong><\/p>\n


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NMPA\u53d1\u5e03\u4e86\u5316\u5b66\u4eff\u5236\u836f\u53c2\u6bd4\u5236\u5242\u9074\u9009\u4e0e\u786e\u5b9a\u5de5\u4f5c\u7a0b\u5e8f\uff0c\u8981\u6c42\u539f\u7814\u836f\u54c1\u9009\u62e9\u987a\u5e8f\u4e3a\u56fd\u5185\u4e0a\u5e02\u7684\u539f\u7814\u836f\u54c1\u3001\u7ecf\u5ba1\u6838\u786e\u5b9a\u7684\u56fd\u5916\u539f\u7814\u4f01\u4e1a\u5728\u4e2d\u56fd\u5883\u5185\u751f\u4ea7\u6216\u7ecf\u6280\u672f\u8f6c\u79fb\u751f\u4ea7\u7684\u836f\u54c1\u3001\u672a\u8fdb\u53e3\u539f\u7814\u836f\u54c1\u3002\u5728\u539f\u7814\u836f\u505c\u6b62\u751f\u4ea7\u6216\u56e0\u8d28\u91cf\u7b49\u539f\u56e0\u6240\u81f4\u5176\u4e0d\u9002\u5408\u4f5c\u4e3a\u53c2\u6bd4\u5236\u5242\u5b9e\uff0c\u53ef\u9009\u62e9\u5728\u7f8e\u65e5\u6b27\u7b49\u89c4\u8303\u56fd\u5bb6\u83b7\u51c6\u4e0a\u5e02\u7684\u56fd\u9645\u516c\u8ba4\u7684\u540c\u79cd\u836f\u54c1\u3001\u7ecf\u5ba1\u6838\u786e\u5b9a\u7684\u5728\u4e2d\u56fd\u5883\u5185\u751f\u4ea7\u6216\u7ecf\u6280\u672f\u8f6c\u79fb\u751f\u4ea7\u7684\u56fd\u9645\u516c\u8ba4\u7684\u540c\u79cd\u836f\u54c1\u3002<\/p>\n


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\u5173\u4e8e\u53d1\u5e03\u300a\u5316\u5b66\u4eff\u5236\u836f\u53c2\u6bd4\u5236\u5242\u76ee\u5f55\uff08\u7b2c\u4e8c\u5341\u4e00\u6279\uff09\u300b\u7684\u516c\u793a<\/strong><\/p>\n


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CDE\u53d1\u5e03\u7b2c\u4e8c\u5341\u4e00\u6279\u4eff\u5236\u836f\u53c2\u6bd4\u5236\u5242\u76ee\u5f55\uff0c\u603b\u8ba1327\u4e2a\u54c1\u89c4\uff0c\u591a\u6570\u4e3a\u6ce8\u5c04\u5242\u3002\u6b64\u6b21\u53c2\u6bd4\u5236\u5242\u76ee\u5f55\u7684\u516c\u793a\u8fdb\u4e00\u6b65\u63a8\u8fdb\u4e86\u6ce8\u5c04\u5242\u4eff\u5236\u836f\u7684\u4e00\u81f4\u6027\u8bc4\u4ef7\u5de5\u4f5c\u8fdb\u5c55\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\"\u884c\u4e1a\u4fe1\u606f|2019\u5e743\u6708\u533b\u836f\u653f\u7b56\u6c47\u7f16\"<\/section>\n
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\u4f18\u5148\u5ba1\u8bc4<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u4f18\u5148\u5ba1\u8bc4\u54c1\u79cd\u516c\u793a\uff1a\u65b0\u589e11\u4e2a\u53d7\u7406\u53f7<\/strong><\/p>\n


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\u65b0\u589e11\u4e2a\u7eb3\u5165\u4f18\u5148\u5ba1\u8bc4\u7684\u53d7\u7406\u53f7\uff0c\u5bf9\u5e949\u4e2a\u54c1\u79cd\uff1a\u5b89\u5fc5\u751f\u7684\u76d0\u9178\u5766\u7d22\u7f57\u8f9b\u7f13\u91ca\u80f6\u56ca\u548c\u6d77\u6b63\u7684\u5bcc\u9a6c\u9178\u55b9\u786b\u5e73\u7f13\u91ca\u7247\u5747\u4ee5\uff08\u4e00\uff095\u6b3e\u6b27\u7f8e\u5171\u7ebf\u7eb3\u5165\u4f18\u5148\u5ba1\u8bc4\u7a0b\u5e8f\uff1b\u4fe1\u7acb\u6cf0\u7684\u76d0\u9178\u4e50\u5361\u5730\u5e73\u7247\u548c\u6d77\u6b63\u7684\u963f\u5361\u6ce2\u7cd6\u7247\u5747\u4ee5\uff08\u4e09\uff092\u6b3e\u64a4\u56de\u91cd\u65b0\u7533\u62a5\u7eb3\u5165\u4f18\u5148\u5ba1\u8bc4\u7a0b\u5e8f\uff0c\u6d77\u6b63\u7684\u6d77\u6cfd\u9ea6\u5e03\u7247\u3001BMS\u7684\u7eb3\u6b66\u5229\u5c24\u5355\u6297\u6ce8\u5c04\u6db2\u3001\u6cfd\u751f\u79d1\u6280\u7684\u6ce8\u5c04\u7528\u91cd\u7ec4\u4eba\u7ebd\u5170\u683c\u6797\u4ee5\uff08\u4e00\uff093\u6b3e\u5177\u6709\u660e\u663e\u6cbb\u7597\u4f18\u52bf\u521b\u65b0\u836f\u7eb3\u5165\u4f18\u5148\u5ba1\u8bc4\u7a0b\u5e8f\uff1b\u79d1\u5174\u751f\u7269\u548c\u6b66\u6c49\u751f\u7269\u7684Sabin\u682a\u810a\u9ad3\u7070\u8d28\u708e\u706d\u6d3b\u75ab\u82d7\uff08Vero\u7ec6\u80de\uff09\u4ee5\uff08\u4e8c\uff096\u6b3e\u513f\u7ae5\u7528\u836f\u7eb3\u5165\u4f18\u5148\u5ba1\u8bc4\u7a0b\u5e8f\u3002<\/mpcpc><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\"\u884c\u4e1a\u4fe1\u606f|2019\u5e743\u6708\u533b\u836f\u653f\u7b56\u6c47\u7f16\"<\/section>\n
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\u5f81\u6c42\u610f\u89c1<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u5173\u4e8e\u516c\u5f00\u5f81\u6c42\u300a\u975e\u9152\u7cbe\u6027\u8102\u80aa\u6027\u809d\u708e\u6cbb\u7597\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6280\u672f\u6307\u5bfc\u539f\u5219\uff08\u8bd5\u884c\uff09\u300b\u610f\u89c1\u7684\u901a\u77e5<\/strong><\/p>\n


<\/p>\n

CDE\u8d77\u8349\u4e86\u300a\u975e\u9152\u7cbe\u6027\u8102\u80aa\u6027\u809d\u708e\u6cbb\u7597\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6280\u672f\u6307\u5bfc\u539f\u5219\uff08\u8bd5\u884c\uff09\u300b\u4e3a\u975e\u9152\u7cbe\u6027\u8102\u80aa\u6027\u809d\u708e\u6cbb\u7597\u836f\u7269\u7684\u4e34\u5e8a\u8bd5\u9a8c\u63d0\u4f9b\u6280\u672f\u6307\u5bfc\u5e76\u516c\u5f00\u5f81\u6c42\u610f\u89c1\u3002\u6307\u5bfc\u539f\u5219\u4ece\u53d7\u8bd5\u8005\u9009\u62e9\u3001\u7ec8\u70b9\u6307\u6807\u8bc4\u4ef7\u3001\u65b9\u6cd5\u5b66\u8bc4\u4ef7\u548c\u4e0d\u540c\u7814\u53d1\u9636\u6bb5\u8003\u8651\u5bf9\u975e\u9152\u7cbe\u6027\u8102\u80aa\u6027\u809d\u708e\u6cbb\u7597\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u505a\u4e86\u76f8\u5173\u89c4\u5b9a\u3002<\/p>\n


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\u5173\u4e8e\u516c\u5f00\u5f81\u6c42ICH M8 (eCTD)\u76f8\u5173\u6587\u4ef6\u548cICH E2F\u793a\u4f8b\u4e2d\u6587\u7ffb\u8bd1\u7a3f\u610f\u89c1\u7684\u901a\u77e5<\/strong><\/p>\n


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\u4e3a\u63a8\u52a8ICH\u6307\u5bfc\u539f\u5219\u5728\u6211\u56fd\u7684\u8f6c\u5316\u5b9e\u65bd\uff0cCDE\u7ec4\u7ec7\u7ffb\u8bd1\u300aICH M8:\u7535\u5b50\u901a\u7528\u6280\u672f\u6587\u6863\uff08eCTD\uff09\u300b\u76f8\u5173\u6587\u4ef6\u548c\u300aICH E2F\uff1a\u7814\u53d1\u671f\u95f4\u5b89\u5168\u6027\u66f4\u65b0\u62a5\u544a\u300b\u793a\u4f8b\uff0c\u5e76\u5bf9\u4e2d\u6587\u7ffb\u8bd1\u7a3f\u516c\u5f00\u5f81\u6c42\u610f\u89c1\u3002<\/p>\n


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\u5173\u4e8e\u516c\u5f00\u5f81\u6c42\u300aeCTD\u6280\u672f\u89c4\u8303\u300b\u548c\u300aeCTD\u9a8c\u8bc1\u6807\u51c6\u300b\u610f\u89c1\u7684\u901a\u77e5<\/strong><\/p>\n


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\u4e3a\u8d2f\u5f7b\u5b9e\u65bd\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\u7684\u6709\u5173\u8981\u6c42\uff0c\u52a0\u5feb\u836f\u54c1\u5ba1\u8bc4\u5ba1\u6279\u4fe1\u606f\u5316\u5efa\u8bbe\uff0c\u63a8\u8fdb\u836f\u54c1\u6309\u7167\u7535\u5b50\u901a\u7528\u6280\u672f\u6587\u6863\u8981\u6c42\u8fdb\u884c\u7533\u62a5\u548c\u53d7\u7406\uff0cCDE\u8d77\u8349\u4e86\u300aeCTD\u6280\u672f\u89c4\u8303\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b\u548c\u300aeCTD\u9a8c\u8bc1\u6807\u51c6\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b\u5e76\u5411\u793e\u4f1a\u516c\u5f00\u5f81\u6c42\u610f\u89c1\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\"\u884c\u4e1a\u4fe1\u606f|2019\u5e743\u6708\u533b\u836f\u653f\u7b56\u6c47\u7f16\"<\/section>\n
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\u5176\u4ed6<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u5173\u4e8e\u7b2c\u4e8c\u6279\u4e34\u5e8a\u6025\u9700\u5883\u5916\u65b0\u836f\u7684\u516c\u793a<\/strong><\/p>\n


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CDE\u516c\u793a\u4e86\u7b2c\u4e8c\u6279\u4e34\u5e8a\u6025\u9700\u5883\u5916\u65b0\u836f\u5171\u8ba130\u4e2a\uff0c\u5927\u591a\u90fd\u662f\u7f55\u89c1\u75c5\u3001\u4e34\u5e8a\u6025\u9700\u7684\u7279\u6548\u836f\uff0c\u5176\u4e2d\u5305\u62ec\u8f89\u745e\u6cbb\u7597\u80ba\u52a8\u8109\u9ad8\u538b\u7684Revatio\uff08\u897f\u5730\u90a3\u975e\uff09\u3001\u8d5b\u8bfa\u83f2\u6cbb\u7597\u591a\u53d1\u6027\u786c\u5316\u7684Lemtrada\uff08Alemtuzumab\uff09\u7b49\u3002\u6309\u7167\u300a\u4e34\u5e8a\u6025\u9700\u5883\u5916\u65b0\u836f\u5ba1\u8bc4\u5ba1\u6279\u5de5\u4f5c\u7a0b\u5e8f\u300b\uff0c\u8fd9\u4e9b\u54c1\u79cd\u4f01\u4e1a\u53ef\u63d0\u4ea4\u76f8\u5173\u8d44\u6599\u540e\u76f4\u63a5\u63d0\u51fa\u4e0a\u5e02\u7533\u8bf7\u3002<\/p>\n


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\u56fd\u52a1\u9662\u53d6\u6d88\u56fd\u4ea7\u836f\u54c1\u6ce8\u518c\u7701\u7ea7\u521d\u5ba1<\/strong><\/p>\n


<\/p>\n

\u56fd\u52a1\u9662\u53d1\u5e03\u300a\u5173\u4e8e\u53d6\u6d88\u548c\u4e0b\u653e\u4e00\u6279\u884c\u653f\u8bb8\u53ef\u4e8b\u9879\u7684\u51b3\u5b9a\u300b\uff0c\u53d6\u6d8825\u9879\u884c\u653f\u8bb8\u53ef\u4e8b\u9879\uff0c\u4e0b\u653e6\u9879\u884c\u653f\u8bb8\u53ef\u4e8b\u9879\u7684\u7ba1\u7406\u5c42\u7ea7\u3002\u53d6\u6d88\u768425\u9879\u884c\u653f\u8bb8\u53ef\u5305\u62ec\uff1a\u56fd\u4ea7\u836f\u54c1\u6ce8\u518c\u521d\u5ba1\u3001\u5047\u80a2\u548c\u77eb\u5f62\u5668(\u8f85\u52a9\u5668\u5177)\u751f\u4ea7\u88c5\u914d\u4f01\u4e1a\u8d44\u683c\u8ba4\u5b9a\u7b49\u3002\u53d6\u6d88\u56fd\u4ea7\u836f\u54c1\u6ce8\u518c\u521d\u5ba1\uff0c\u5373\u4eca\u540e\u56fd\u4ea7\u836f\u54c1\u5728\u8fdb\u884c\u6ce8\u518c\u7533\u62a5\u65f6\uff0c\u65e0\u9700\u518d\u8d70\u7701\u7ea7\u836f\u76d1\u90e8\u95e8\u7684\u521d\u5ba1\u73af\u8282\uff0c\u7531\u56fd\u5bb6\u836f\u76d1\u5c40\u76f4\u63a5\u53d7\u7406\u56fd\u4ea7\u836f\u54c1\u7684\u6ce8\u518c\u7533\u8bf7\u3002<\/p>\n


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\u300a2019\u5e74\u56fd\u5bb6\u533b\u4fdd\u836f\u54c1\u76ee\u5f55\u8c03\u6574\u5de5\u4f5c\u65b9\u6848\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b\u516c\u5f00\u5f81\u6c42\u610f\u89c1<\/strong><\/p>\n


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\u610f\u89c1\u7a3f\u6307\u51fa2019\u5e74\u533b\u4fdd\u76ee\u5f55\u8c03\u5165\u54c1\u79cd\u4f18\u5148\u8003\u8651\u56fd\u5bb6\u57fa\u672c\u836f\u7269\u3001\u764c\u75c7\u53ca\u7f55\u89c1\u75c5\u7b49\u91cd\u5927\u75be\u75c5\u6cbb\u7597\u7528\u836f\u3001\u6162\u6027\u75c5\u7528\u836f\u3001\u513f\u7ae5\u7528\u836f\u3001\u6025\u6551\u62a2\u6551\u7528\u836f\u7b49\u3002\u4f18\u5148\u9009\u62e9\u6709\u5145\u5206\u8bc1\u636e\u8bc1\u660e\u5176\u4e34\u5e8a\u5fc5\u9700\u3001\u5b89\u5168\u6709\u6548\u3001\u4ef7\u683c\u5408\u7406\u7684\u54c1\u79cd\u3002\u8c03\u5165\u5206\u4e3a\u5e38\u89c4\u51c6\u5165\u548c\u8c08\u5224\u51c6\u5165\u4e24\u79cd\u65b9\u5f0f\uff0c\u5728\u6ee1\u8db3\u6709\u6548\u6027\u3001\u5b89\u5168\u6027\u7b49\u524d\u63d0\u4e0b\uff0c\u4ef7\u683c\uff08\u8d39\u7528\uff09\u4e0e\u836f\u54c1\u76ee\u5f55\u5185\u73b0\u6709\u54c1\u79cd\u76f8\u5f53\u6216\u8f83\u4f4e\u7684\uff0c\u53ef\u4ee5\u901a\u8fc7\u5e38\u89c4\u65b9\u5f0f\u7eb3\u5165\u76ee\u5f55\uff0c\u4ef7\u683c\u8f83\u9ad8\u6216\u5bf9\u533b\u4fdd\u57fa\u91d1\u5f71\u54cd\u8f83\u5927\u7684\u4e13\u5229\u72ec\u5bb6\u836f\u54c1\u5e94\u5f53\u901a\u8fc7\u8c08\u5224\u65b9\u5f0f\u51c6\u5165\u3002<\/p>\n

<\/mpcpc><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\u6b27\u76df\u53d1\u5e03\u300a\u706d\u83cc\u5de5\u827a\u6307\u5357\u300b\uff0c2019\u5e7410\u67081\u65e5\u8d77\u5b9e\u65bd\uff0c\u5c06\u53d6\u4ee3\u706d\u83cc\u51b3\u7b56\u6811\u6587\u4ef6<\/strong><\/span><\/h2>\n
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\n

3\u67088\u65e5\uff0cEMA \u53d1\u5e03\u4e86\u65b0\u7684\u300a\u836f\u54c1\u3001\u6d3b\u6027\u7269\u8d28\u3001\u8f85\u6599\u548c\u5185\u5305\u6750\u706d\u83cc\u6307\u5bfc\u539f\u5219<\/strong><\/span>\u300b \u3002\u8be5\u6307\u5357\u5c06\u53d6\u4ee3\u706d\u83cc\u51b3\u7b56\u6811\u6587\u4ef6CPMP\/QWP\/054v98\uff0c\u4e3a\u65e0\u83cc\u4ea7\u54c1\u9009\u62e9\u5408\u9002\u7684\u706d\u83cc\u65b9\u6cd5\u63d0\u4f9b\u4e86\u4f9d\u636e\u548c\u6307\u5bfc\u3002\u8be5\u6307\u5357\u89e3\u8bfb\u5982\u4e0b\uff1a<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n


<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

\u4e00\u822c\u8981\u6c42\uff1a<\/span><\/strong><\/p>\n


<\/p>\n

\u2705 \u5e94\u6307\u5b9a\u706d\u83cc\u524d\u7684\u751f\u7269\u8d1f\u8377\u63a7\u5236\u6807\u51c6<\/span>\u3002<\/p>\n


<\/p>\n

\u2705 \u5e94\u89c4\u5b9a\u7ec4\u4ef6\u548c\u5f85\u704c\u88c5\u6eb6\u6db2\u7684\u751f\u7269\u8d1f\u8377\u548c\u7ec6\u83cc\u5185\u6bd2\u7d20\uff08\u5982\u9002\u7528\uff09\u7684\u63a5\u53d7\u6807\u51c6\u3002<\/span><\/p>\n


<\/p>\n

\u2705 \u5982\u679c\u4f7f\u7528\u4e8c\u7ea7\u5bb9\u5668 (\u4f8b\u5982\u7528\u4e8e\u4fdd\u6301\u8f93\u6db2\u888b\u6216\u6ce1\u7f69\u5916\u90e8\u65e0\u83cc\u7684\u5916\u888b)\uff0c\u5e94\u8bf4\u660e\u5305\u88c5\u8fc7\u7a0b\uff0c\u5305\u62ec\u98ce\u9669\u8bc4\u4f30\uff0c\u56e0\u4e3a\u5b83\u53ef\u80fd\u4f1a\u5f71\u54cd\u6210\u54c1\u7684\u65e0\u83cc\u6027\uff1b\u4f8b\u5982\uff0c\u5728\u5185\u5305\u88c5\u5bb9\u5668\u548c\u4e8c\u7ea7\u5bb9\u5668\u4e4b\u95f4\u6b8b\u7559\u6c34\u5206<\/span>\u3002\u5e94\u63d0\u4f9b\u5173\u4e8e\u4f55\u65f6 (\u706d\u83cc\u524d\u6216\u706d\u83cc\u540e) \u8fdb\u884c\u5305\u88c5\u6b65\u9aa4\u4ee5\u53ca\u6240\u91c7\u7528\u7684\u4efb\u4f55\u65e0\u83cc\u6280\u672f\u7684\u4fe1\u606f\u3002\u5de5\u827a\u5e94\u4ece\u5fae\u751f\u7269\u7684\u89d2\u5ea6\u52a0\u4ee5\u8bc1\u660e\u3002\u5982\u679c\u4f7f\u7528\u4e8c\u7ea7\u5bb9\u5668\u610f\u5473\u7740\u9700\u8981\u5bf9\u6210\u54c1\u8fdb\u884c\u989d\u5916\u7684\u706d\u83cc\uff0c\u5219\u5e94\u5728\u65e0\u83cc\u4fdd\u8bc1\u548c\u5bf9\u6210\u54c1\u8d28\u91cf\u7684\u4efb\u4f55\u6f5c\u5728\u5f71\u54cd\u65b9\u9762\u8fdb\u884c\u8bba\u8bc1\u3002<\/p>\n

 <\/p>\n

\u84b8\u6c7d\u706d\u83cc\uff1a<\/span><\/strong><\/p>\n


<\/p>\n

\u2705 \u6240\u6709\u84b8\u6c7d\u706d\u83cc\u5de5\u827a\u90fd\u8981\u6c42\u6700\u4f4e\u6740\u706d\u529b\u4e3a F0\u22658\u5206\u949f\uff0c\u6700\u4f4e\u5de5\u827a\u6e29\u5ea6\u4e3a110\u00b0C<\/span>\u3002<\/p>\n


<\/p>\n

\u2705 \u5982\u679c\u4f7f\u7528F0\u4f5c\u4e3a\u76d1\u6d4b\u5de5\u827a\u6740\u706d\u529b\u7684\u989d\u5916\u63a7\u5236\uff0c\u5219\u5e94\u8bf4\u660e F0\uff0c\u5e76\u7531\u6e29\u5ea6\u4f20\u611f\u5668\u6d4b\u91cf\u7684\u6700\u4f4e\u6e29\u5ea6\u6765\u786e\u5b9a F0<\/span>\u3002<\/p>\n


<\/p>\n

\u2705 \u6210\u54c1\u6e29\u5ea6\u4f4e\u4e8e115\u00b0C\u7684\u84b8\u6c7d\u706d\u83cc\u4fdd\u6301\u9636\u6bb5\u662f\u4e00\u79cd\u7279\u6b8a\u60c5\u51b5\uff0c \u5e94\u8fdb\u884c\u8bba\u8bc1<\/p>\n


<\/p>\n

\u2705 \u5982\u679c F0 \u7684\u6d4b\u5b9a\u4e2d\u5305\u62ec\u4f4e\u4e8e110\u00b0C \u7684\u6e29\u5ea6 (\u5728\u52a0\u70ed\u548c\u51b7\u5374\u8fc7\u7a0b\u4e2d)\uff0c\u5219\u5e94\u8fdb\u884c\u8bba\u8bc1\u3002<\/span><\/p>\n


<\/p>\n

\u2705 F0\uff1c8\u53ef\u4ee5\u4f5c\u4e3a\u65e0\u83cc\u52a0\u5de5\u7684\u7ec8\u7aef\u70ed\u5904\u7406\uff0c\u4e0d\u5e94\u4f5c\u4e3a\u4e0d\u826f\u65e0\u83cc\u751f\u4ea7\u64cd\u4f5c\u7684\u8865\u507f\u3002\u6709\u6ca1\u6709\u65e0\u83cc\u52a0\u5de5\u7ec8\u7aef\u70ed\u5904\u7406\u5728\u65e0\u83cc\u5de5\u827a\u90e8\u5206\u7684\u8981\u6c42\u662f\u4e00\u6837\u7684\u3002<\/p>\n


<\/p>\n

\u2705 \u5c3d\u7ba1\u4f7f\u7528\u8fc7\u5ea6\u6740\u706d\uff0c\u4e5f\u5e94\u5b9a\u4e49\u706d\u83cc\u524d\u7684\u751f\u7269\u8d1f\u8377\u6c34\u5e73\uff08\u2264100 CFU\/100ml\uff09<\/span>\uff0c\u5bf9\u4e8e\u84b8\u6c7d\u706d\u83cc\u524d\u7684\u751f\u7269\u8d1f\u8377\u6c34\u5e73\u8981\u6c42\u5982\u4e0b\uff1a<\/p>\n


<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\"\u884c\u4e1a\u4fe1\u606f|2019\u5e743\u6708\u533b\u836f\u653f\u7b56\u6c47\u7f16\"<\/section>\n<\/section>\n<\/section>\n
\n
\n
\n


<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

\u2705 \u5bf9\u4e8eF0\uff1c8\u7684\u5de5\u827a\uff0c\u8981\u6c42\u5f85\u5904\u7406\u6eb6\u6db2\u7684\u751f\u7269\u8d1f\u8377\u22640CFU\/100ml\u3002<\/span><\/p>\n


<\/p>\n

\u2705 \u5982\u6240\u4f7f\u7528\u751f\u7269\u6307\u793a\u5242D\u503c\uff1c1.5min<\/span>\uff0c\u5e94\u5bf9\u706d\u83cc\u524d\u751f\u7269\u8d1f\u8377\u8fdb\u884c\u9274\u5b9a\uff0c\u5e76\u786e\u8ba4\u5176\u8010\u70ed\u6027\u3002\u5e94\u8bba\u8bc1\u706d\u83cc\u9636\u6bb5\u5f00\u59cb\u548c\u7ed3\u675f\uff0c\u5373\u8bb0\u5f55F0\u7684\u5f00\u59cb\u548c\u7ed3\u675f\u3002<\/p>\n


<\/p>\n

\u2705 \u5bf9\u4e8e\u91c7\u7528\u8fc7\u6740\u7684\u706d\u83cc\u7a0b\u5e8f\uff0c\u9700\u8bc1\u660e\u5fae\u751f\u7269\u4e0b\u964d12\u4e2alog\u3002<\/p>\n


<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

\u5e72\u70ed\u706d\u83cc\uff1a<\/span><\/strong><\/p>\n


<\/p>\n

\u2705 \u5bf9\u4e8e\u80a0\u5916\u6210\u54c1\u5236\u5242\uff0c \u5728\u6ca1\u6709\u8fdb\u4e00\u6b65\u7406\u7531\u7684\u60c5\u51b5\u4e0b\uff0c\u6700\u5927\u751f\u7269\u8d1f\u8377\u4e3a 100 CFU\/100 g \u6216 100 CFU\/100 \u6beb\u5347<\/span>\u3002<\/p>\n


<\/p>\n

\u2705 \u5bf9\u4e8e\u975e\u80a0\u5916\u7ed9\u836f\u7684\u6d3b\u6027\u7269\u8d28\u548c\u6210\u54c1\uff0c \u6700\u5927\u751f\u7269\u8d1f\u8377\u4e3a 10 CFU\/g\u6216 10 CFU\/ml<\/span>\u3002<\/p>\n


<\/p>\n

\u2705 \u5728\u6e29\u5ea6\u5927\u4e8e220\u00b0C \u7684\u60c5\u51b5\u4e0b\uff0c\u53ef\u5c06\u8010\u70ed\u5185\u6bd2\u7d20\u76843\u4e2alog\u4e0b\u964d\u503c\u4f5c\u4e3a\u9a8c\u8bc1\u6807\u51c6\u3002<\/p>\n

 <\/p>\n

\u7535\u79bb\u8f90\u5c04\u706d\u83cc\uff1a<\/span><\/strong><\/p>\n


<\/p>\n

\u2705 \u8981\u6c42\u5438\u6536\u5242\u91cf\u226525 kGy<\/span>\u3002\u5176\u4ed6\u5242\u91cf\u5982\u7ecf\u8bba\u8bc1\u548c\u9a8c\u8bc1\u53ef\u5b9e\u73b0sal\u226410-6\u4e5f\u53ef\u4ee5\u3002<\/p>\n

 <\/p>\n

\u6c14\u4f53\u706d\u83cc\uff1a<\/span><\/strong><\/p>\n


<\/p>\n

\u2705 \u4e00\u822c\u6765\u8bf4\uff0c\u53ea\u6709\u5728\u6ca1\u6709\u5176\u4ed6\u706d\u83cc\u65b9\u6cd5\u7684\u60c5\u51b5\u4e0b\uff0c\u6c14\u4f53\u706d\u83cc\u624d\u662f\u53ef\u4ee5\u63a5\u53d7\u7684<\/span>\u3002<\/p>\n


<\/p>\n

\u2705 \u6c14\u4f53\u706d\u83cc\u53ef\u5bf9\u6750\u6599\u8868\u9762\u8fdb\u884c\u706d\u83cc\u3002\u5b83\u4e3b\u8981\u7528\u4e8e\u5bf9\u5305\u88c5\u6750\u6599\u548c\u8bbe\u5907\u8fdb\u884c\u706d\u83cc\uff0c \u56e0\u6b64\u53ea\u5305\u62ec\u5728\u5bb9\u5668\u7684\u51b3\u7b56\u6811\u4e2d<\/span>\u3002<\/p>\n


<\/p>\n

\u2705 \u5e94\u8bc1\u660e\u6c14\u4f53\u6e05\u9664\u8fc7\u7a0b\u7684\u6709\u6548\u6027<\/span><\/p>\n


<\/p>\n

\u2705 \u5bf9\u591a\u5b54\u88c5\u8f7d (\u5982\u5e72\u7c89) \u8fdb\u884c\u6c14\u4f53\u706d\u83cc\u662f\u4e0d\u53ef\u63a5\u53d7\u7684<\/span>\uff0c\u9664\u975e\u5176\u4ed6\u706d\u83cc\u65b9\u6cd5\u4e0d\u53ef\u884c\uff0c\u5e76\u7ecf\u79d1\u5b66\u8bba\u8bc1\u3002<\/p>\n


<\/p>\n

\u2705 \u5728\u6c14\u4f53\u706d\u83cc\u4e4b\u524d\uff0c\u6d3b\u6027\u7269\u8d28\u6216\u8f85\u6599\u5e94\u5728\u65e0\u83cc\u6761\u4ef6\u4e0b\u8fdb\u884c\u65e0\u83cc\u8fc7\u6ee4\u548c\u7ed3\u6676<\/span>\uff0c\u4ee5\u6700\u5927\u9650\u5ea6\u5730\u51cf\u5c11\u5fae\u751f\u7269\u5728\u6676\u4f53\u4e2d\u7684\u5438\u6536\u548c\u5305\u88f9\u3002<\/p>\n


<\/p>\n

\u2705 \u53c2\u6570\u653e\u884c\u5bf9\u4e8e\u6c14\u4f53\u706d\u83cc\u662f\u4e0d\u53ef\u63a5\u53d7\u7684<\/span><\/p>\n


<\/p>\n

\u2705 \u5bf9\u4e8e\u73af\u6c27\u4e59\u70f7\u706d\u83cc\uff0c\u5e94\u6709\u98ce\u9669\u8bc4\u4f30\u8003\u8651\u5df2\u77e5\u7684\u6b8b\u7559\u9057\u4f20\u6bd2\u6027\u6742\u8d28 (\u5982\u73af\u6c27\u4e59\u70f7\u548c\u5364\u5316\u4e59\u70ef\u9187)\u3002\u5e94\u6839\u636eICH M7\u8fdb\u884c\u8bc4\u4f30\u3002<\/p>\n


<\/p>\n

\u2705 \u5728\u4e0d\u9002\u7528 ICH M7\u9650\u5236\u7684\u60c5\u51b5\u4e0b\uff0c \u73af\u6c27\u4e59\u70f7\u706d\u83cc\u4ea7\u751f\u7684\u6709\u6bd2\u6c14\u4f53\u6b8b\u7559\u9650\u503c<\/p>\n


<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\"\u884c\u4e1a\u4fe1\u606f|2019\u5e743\u6708\u533b\u836f\u653f\u7b56\u6c47\u7f16\"<\/section>\n<\/section>\n<\/section>\n
\n
\n
\n


<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

\u9664\u83cc\u8fc7\u6ee4\uff1a<\/span><\/strong><\/p>\n


<\/p>\n

\u2705 \u9664\u83cc\u8fc7\u6ee4\u5668\u7684\u5b8c\u6574\u6027\u5e94\u5728\u4f7f\u7528\u524d\u901a\u8fc7\u6d4b\u8bd5\u8fdb\u884c\u786e\u8ba4<\/span>\uff0c \u9664\u975e\u6709\u660e\u786e\u7684\u8bc1\u660e\u548c\u9a8c\u8bc1\uff0c\u5e76\u5e94\u5728\u4f7f\u7528\u540e\u7acb\u5373\u901a\u8fc7\u5728\u7ebf\u6d4b\u8bd5\u8fdb\u884c\u786e\u8ba4<\/span>\u3002<\/p>\n


<\/p>\n

\u2705 \u5728\u5927\u591a\u6570\u60c5\u51b5\u4e0b\uff0c \u8fc7\u6ee4\u524d\u751f\u7269\u8d1f\u8377\u6d4b\u8bd5\u53ef\u4ee5\u63a5\u53d7\u2264 10 CFU\/100 ml (\u603b\u9700\u6c27\u83cc\u8ba1\u6570)\u3002<\/p>\n


<\/p>\n

\u2705 \u5728\u4f7f\u7528\u9884\u8fc7\u6ee4\u5668\u7684\u60c5\u51b5\u4e0b\uff0c\u5982\u679c\u7531\u4e8e\u5df2\u77e5\u5177\u6709\u56fa\u6709\u5fae\u751f\u7269\u6c61\u67d3\u7684\u8d77\u59cb\u6750\u6599\uff0c\u5728\u9884\u8fc7\u6ee4\u524d\u751f\u7269\u91cf\u9650\u5236\u9ad8\u4e8e 10 CFU\/100 ml \u53ef\u80fd\u662f\u53ef\u4ee5\u63a5\u53d7\u7684\u3002\u5728\u8fd9\u79cd\u60c5\u51b5\u4e0b\uff0c\u5e94\u8bc1\u660e\u7b2c\u4e00\u4e2a\u8fc7\u6ee4\u5668\u80fd\u591f\u5728\u6700\u540e\u4e00\u6b21\u8fc7\u6ee4\u4e4b\u524d\u8fbe\u5230\u226410CFU\/100 ml \u7684\u751f\u7269\u8d1f\u8377\u3002<\/p>\n


<\/p>\n

\u2705 \u5e94\u89c4\u5b9a\u4ece\u6eb6\u6db2\u5236\u5907\u5230\u9664\u83cc\u8fc7\u6ee4\u4e4b\u95f4\u7684\u6700\u957f\u65f6\u95f4<\/span><\/p>\n


<\/p>\n

\u2705 \u8fc7\u6ee4\u65f6\u95f4\u8d85\u8fc724\u5c0f\u65f6\u5e94\u8fdb\u884c\u8bba\u8bc1<\/span><\/p>\n


<\/p>\n

\u2705 \u5982\u679c\u65e0\u83cc\u8fc7\u6ee4\u6563\u88c5\u6eb6\u6db2\u672a\u572824\u5c0f\u65f6\u5185\u704c\u5165\u6700\u7ec8\u4ea7\u54c1\u5bb9\u5668\uff0c\u9664\u975e\u6709\u6b63\u5f53\u7406\u7531\uff0c\u5426\u5219\u5e94\u5728\u704c\u88c5\u524d\u91cd\u65b0\u8fdb\u884c\u9664\u83cc\u8fc7\u6ee4\u3002<\/span><\/p>\n


<\/p>\n

\u2705 \u4fdd\u6301\u65f6\u95f4\u5e94\u8fdb\u884c\u5145\u5206\u7684\u8bba\u8bc1\u3002<\/span><\/p>\n

 <\/p>\n

\u5439\u704c\u5c01-\u65e0\u83cc\u5de5\u827a\uff1a<\/span><\/strong><\/p>\n


<\/p>\n

\u2705 \u5728\u65e0\u83cc\u5904\u7406\u4ea7\u54c1\u4f7f\u7528\u5439\u704c\u5c01\u6280\u672f\u7684\u60c5\u51b5\u4e0b\uff0c\u5e94\u63d0\u4f9b\u9a8c\u8bc1\u6570\u636e\u603b\u7ed3<\/span>\uff0c\u4ee5\u786e\u8ba4\u6240\u751f\u4ea7\u7684\u5bb9\u5668\u662f\u65e0\u83cc\u7684\u3002\u9a8c\u8bc1\u5e94\u4f7f\u7528\u5177\u6709\u9002\u5f53\u8010\u53d7\u6027\u7684\u751f\u7269\u6307\u793a\u5242<\/span>\uff0c\u8bc1\u660e\u5bb9\u5668\u8868\u9762\u7684SAL\u226410-6\u3002<\/p>\n


<\/p>\n

\u2705 \u5e94\u63a7\u5236\u7528\u4e8e\u5236\u9020\u5439\u704c\u5c01\u5bb9\u5668\u7684\u6750\u6599\u7684\u751f\u7269\u8d1f\u8377\u3002<\/span><\/p>\n


\u706d\u83cc\u5de5\u827a\u9009\u62e9\u51b3\u7b56\u6811\uff1a<\/span><\/strong><\/p>\n


<\/p>\n

\u2705 \u5bf9\u4e8e\u6eb6\u6db2\u5242\u578b\u4ea7\u54c1\u706d\u83cc\u65b9\u6cd5\u9009\u62e9\u7684\u51b3\u7b56\u6811\uff1a<\/span><\/p>\n


<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\"\u884c\u4e1a\u4fe1\u606f|2019\u5e743\u6708\u533b\u836f\u653f\u7b56\u6c47\u7f16\"<\/section>\n<\/section>\n<\/section>\n
\n
\n
\n


<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

\u2705 \u975e\u6eb6\u6db2\u5242\u578b\u3001\u534a\u56fa\u4f53\u6216\u5e72\u7c89\u4ea7\u54c1\u706d\u83cc\u65b9\u6cd5\u9009\u62e9\u7684\u51b3\u7b56\u6811<\/span>\uff1a<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\"\u884c\u4e1a\u4fe1\u606f|2019\u5e743\u6708\u533b\u836f\u653f\u7b56\u6c47\u7f16\"<\/section>\n<\/section>\n<\/section>\n
\n
\n
\n


<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

\u2705 \u6307\u5357\u8f83\u4e4b\u4e0a\u4e00\u7248\u589e\u52a0\u4e86\u5bb9\u5668\u706d\u83cc\u5de5\u827a\u9009\u62e9\u7684\u51b3\u7b56\u6811<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\"\u884c\u4e1a\u4fe1\u606f|2019\u5e743\u6708\u533b\u836f\u653f\u7b56\u6c47\u7f16\"<\/section>\n<\/section>\n<\/section>\n
\n
\n
\n


<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

\u300a\u4e2d\u56fd\u836f\u5178\u300b2020\u5e74\u7248\u56db\u90e8\u589e\u4fee\u8ba2\u4e4b\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u6307\u5bfc\u539f\u5219<\/strong><\/span><\/h2>\n


<\/strong><\/span><\/p>\n

\u2705 <\/span>\u5220\u51cf\u90e8\u5206<\/span><\/strong><\/p>\n


<\/span><\/p>\n

9101<\/span>\u836f\u54c1\u8d28\u91cf\u6807\u51c6<\/span>\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u6307\u5bfc\u539f\u5219
<\/span><\/p>\n


<\/p>\n

\u88681 \u68c0\u9a8c\u9879\u76ee\u548c\u9a8c\u8bc1\u6307\u6807<\/span><\/p>\n

\u5220\u9664\u201c<\/span>\u6821\u6b63\u56e0\u5b50<\/span>\u201d\u9879<\/span><\/span><\/p>\n


<\/p>\n

\u51c6\u786e\u5ea6<\/span><\/strong>\u9879\u4e0b<\/span><\/p>\n

\u56de\u6536\u7387% =\uff08C\u2212A\uff09B\u2044\u00d7100% <\/span><\/p>\n

\u5f0f\u4e2dA\u4e3a\u4f9b\u8bd5\u54c1\u6240\u542b\u88ab\u6d4b\u6210\u5206\u91cf\uff1b<\/span><\/p>\n

B\u4e3a\u52a0\u5165\u5bf9\u7167\u54c1\u91cf\uff1b<\/span><\/p>\n

C\u4e3a\u5b9e\u6d4b\u503c\u3002<\/span><\/p>\n


<\/p>\n

4. \u6821\u6b63\u56e0\u5b50\u7684\u51c6\u786e\u5ea6<\/span><\/p>\n

\u5bf9\u8272\u8c31\u65b9\u6cd5\u800c\u8a00\uff0c\u7edd\u5bf9\uff08\u6216\u5b9a\u91cf\uff09\u6821\u6b63\u56e0\u5b50\u662f\u6307\u5355\u4f4d\u9762\u79ef\u7684\u8272\u8c31\u5cf0\u4ee3\u8868\u7684\u5f85\u6d4b\u7269\u8d28\u7684\u91cf\u3002\u5f85\u6d4b\u5b9a\u7269\u8d28\u4e0e\u6240\u9009\u5b9a\u7684\u53c2\u7167\u7269\u8d28\u7684\u7edd\u5bf9\u6821\u6b63\u56e0\u5b50\u4e4b\u6bd4\uff0c\u5373\u4e3a\u76f8\u5bf9\u6821\u6b63\u56e0\u5b50\u3002\u76f8\u5bf9\u6821\u6b63\u56e0\u5b50\u8ba1\u7b97\u6cd5\u5e38\u5e94\u7528\u4e8e\u5316\u5b66\u836f\u6709\u5173\u7269\u8d28\u7684\u6d4b\u5b9a\u3001\u4e2d\u836f\u6750\u53ca\u5176\u590d\u65b9\u5236\u5242\u4e2d\u591a\u6307\u6807\u6210\u5206\u7684\u6d4b\u5b9a\u3002\u6821\u6b63\u56e0\u5b50\u7684\u8868\u793a\u65b9\u6cd5\u5f88\u591a\uff0c\u672c\u6307\u5bfc\u539f\u5219\u4e2d\u7684\u6821\u6b63\u56e0\u5b50\u662f\u6307\u6c14\u76f8\u8272\u8c31\u6cd5\u548c\u9ad9\u6548\u6db2\u76f8\u8272\u8c31\u6cd5\u4e2d\u7684\u76f8\u5bf9\u91cd\u91cf\u6821\u6b63\u56e0\u5b50\u3002<\/span><\/p>\n


<\/p>\n

\u76f8\u5bf9\u6821\u6b63\u56e0\u5b50\u53ef\u91c7\u7528\u66ff\u4ee3\u7269\uff08\u5bf9\u7167\u54c1\uff09\u548c\u88ab\u66ff\u4ee3\u7269\uff08\u5f85\u6d4b\u7269\uff09\u6807\u51c6\u66f2\u7ebf\u659c\u7387\u6bd4\u503c\u8fdb\u884c\u6bd4\u8f83\u83b7\u5f97\uff1b\u91c7\u7528\u7d2b\u5916\u5438\u6536\u68c0\u6d4b\u5668\u65f6\uff0c\u53ef\u5c06\u66ff\u4ee3\u7269\uff08\u5bf9\u7167\u54c1\uff09\u548c\u88ab\u66ff\u4ee3\u7269\uff08\u5f85\u6d4b\u7269\uff09\u5728\u89c4\u5b9a\u6ce2\u957f\u548c\u6eb6\u5242\u6761\u4ef6\u4e0b\u7684\u5438\u6536\u7cfb\u6570\u6bd4\u503c\u8fdb\u884c\u6bd4\u8f83\uff0c\u8ba1\u7b97\u83b7\u5f97\u3002<\/span><\/p>\n


<\/p>\n

4.\u6570\u636e\u8981\u6c42<\/span><\/strong><\/p>\n

\u5728\u89c4\u5b9a\u8303\u56f4\u5185\uff0c<\/span>\u53d6\u540c\u4e00\u6d53\u5ea6\uff08\u76f8\u5f53\u4e8e100%\u6d53\u5ea6\u6c34\u5e73\uff09\u7684\u4f9b\u8bd5\u54c1\uff0c\u7528\u81f3\u5c11\u6d4b\u5b9a6\u4efd\u6837\u54c1\u7684\u7ed3\u679c\u8fdb\u884c\u8bc4\u4ef7\uff1b\u6216<\/span>\u8bbe\u8ba13\u79cd\u4e0d\u540c\u6d53\u5ea6\uff0c\u6bcf\u79cd\u6d53\u5ea6\u5206\u522b\u5236\u59073\u4efd\u4f9b\u8bd5\u54c1\u6eb6\u6db2\u8fdb\u884c\u6d4b\u5b9a\uff0c\u75289\u4efd\u6837\u54c1\u7684\u6d4b\u5b9a\u7ed3\u679c\u8fdb\u884c\u8bc4\u4ef7\u3002<\/span><\/p>\n


<\/p>\n

\u5bf9\u4e8e\u5316\u5b66\u836f\uff0c<\/span>\u4e00\u822c\u4e2d\u95f4\u6d53\u5ea6\u52a0\u5165\u91cf\u4e0e\u6240\u53d6\u4f9b\u8bd5\u54c1\u4e2d\u5f85\u6d4b\u5b9a\u6210\u5206\u91cf\u4e4b\u6bd4\u63a7\u5236\u57281:1\u5de6\u53f3\uff0c\u5efa\u8bae\u9ad8\u3001\u4e2d\u3001\u4f4e\u6d53\u5ea6\u5bf9\u7167\u54c1\u52a0\u5165\u91cf\u4e0e\u6240\u53d6\u4f9b\u8bd5\u54c1\u4e2d\u5f85\u6d4b\u5b9a\u6210\u5206\u91cf\u4e4b\u6bd4\u63a7\u5236\u57281.2:1\uff0c1:1\uff0c0.8:1\u5de6\u53f3\uff0c<\/span>\u5e94\u62a5\u544a\u5df2\u77e5\u52a0\u5165\u91cf\u7684\u56de\u6536\u7387\uff08%\uff09\uff0c\u6216\u6d4b\u5b9a\u7ed3\u679c\u5e73\u5747\u503c\u4e0e\u771f\u5b9e\u503c\u4e4b\u5dee\u53ca\u5176\u76f8\u5bf9\u6807\u51c6\u504f\u5dee\u6216\u7f6e\u4fe1\u533a\u95f4\uff08\u7f6e\u4fe1\u5ea6\u4e00\u822c\u4e3a95%\uff09\uff1b\u5bf9\u4e8e\u4e2d\u836f\uff0c<\/span>\u4e00\u822c\u4e2d\u95f4\u6d53\u5ea6\u52a0\u5165\u91cf\u4e0e\u6240\u53d6\u4f9b\u8bd5\u54c1\u4e2d\u5f85\u6d4b\u5b9a\u6210\u5206\u91cf\u4e4b\u6bd4\u63a7\u5236\u57281:1\u5de6\u53f3\uff0c\u5efa\u8bae\u9ad8\u3001\u4e2d\u3001\u4f4e\u6d53\u5ea6\u5bf9\u7167\u54c1\u52a0\u5165\u91cf\u4e0e\u6240\u53d6\u4f9b\u8bd5\u54c1\u4e2d\u5f85\u6d4b\u5b9a\u6210\u5206\u91cf\u4e4b\u6bd4\u63a7\u5236\u57281.5:1\uff0c1:1\uff0c0.5:1\u5de6\u53f3\uff0c<\/span>\u5e94\u62a5\u544a\u4f9b\u8bd5\u54c1\u53d6\u6837\u91cf\u3001\u4f9b\u8bd5\u54c1\u4e2d\u542b\u6709\u91cf\u3001\u5bf9\u7167\u54c1\u52a0\u5165\u91cf\u3001\u6d4b\u5b9a\u7ed3\u679c\u548c\u56de\u6536\u7387\uff08%\uff09\u8ba1\u7b97\u503c\uff0c\u4ee5\u53ca\u56de\u6536\u7387\uff08%\uff09\u7684\u76f8\u5bf9\u6807\u51c6\u504f\u5dee\uff08RSD%\uff09\u6216\u7f6e\u4fe1\u533a\u95f4\u3002<\/span>\u5bf9\u4e8e\u6821\u6b63\u56e0\u5b50\uff0c\u5e94\u62a5\u544a\u6d4b\u5b9a\u65b9\u6cd5\u3001\u6d4b\u5b9a\u7ed3\u679c\u548cRSD%\u3002<\/span>\u6837\u54c1\u4e2d\u5f85\u6d4b\u5b9a\u6210\u5206\u542b\u91cf\u548c\u56de\u6536\u7387\u9650\u5ea6\u5173\u7cfb\u53ef\u53c2\u8003\u88682\u3002<\/span><\/p>\n


<\/p>\n

\u56db\u3001\u68c0\u6d4b\u9650<\/span><\/strong><\/p>\n

\u836f\u54c1\u7684\u9274\u522b\u8bd5\u9a8c\u548c\u6742\u8d28\u68c0\u67fb\u65b9\u6cd5\uff0c\u5747\u5e94\u901a\u8fc7\u6d4b\u8bd5\u786e\u5b9a\u65b9\u6cd5\u7684\u68c0\u6d4b\u9650\u3002<\/span><\/p>\n


<\/p>\n

\u4e03\u3001\u8303\u56f4<\/span><\/strong><\/p>\n

\u5728\u4e2d\u836f\u5206\u6790\u4e2d\uff0c<\/span>\u8303\u56f4\u5e94\u6839\u636e\u5206\u6790\u65b9\u6cd5\u7684\u5177\u4f53\u5e94\u7528\u548c\u7ebf\u6027\u3001\u51c6\u786e\u5ea6\u3001\u7cbe\u5bc6\u5ea6\u7ed3\u679c\u53ca\u8981\u6c42\u786e\u5b9a\u3002<\/span>\u5bf9\u4e8e\u6709\u6bd2\u7684\u3001\u5177\u7279\u6b8a\u529f\u6548\u6216\u836f\u7406\u4f5c\u7528\u7684\u6210\u5206\uff0c\u5176\u9a8c\u8bc1\u8303\u56f4\u5e94\u5927\u4e8e\u88ab\u9650\u5b9a\u542b\u91cf\u7684\u533a\u95f4\u3002<\/span><\/p>\n


<\/p>\n

\u6821\u6b63\u56e0\u5b50\u6d4b\u5b9a\u65f6\uff0c\u8303\u56f4\u4e00\u822c\u5e94\u6839\u636e\u5176\u5e94\u7528\u5bf9\u8c61\u7684\u6d4b\u5b9a\u8303\u56f4\u786e\u5b9a\u3002<\/span><\/p>\n


<\/p>\n

\u516b\u3001\u8010\u7528\u6027<\/span><\/strong><\/p>\n

\u9ad8\u6548<\/span>\u6db2\u76f8\u8272\u8c31\u6cd5\u4e2d\u5178\u578b\u7684\u53d8\u52a8\u56e0\u7d20<\/span><\/p>\n


<\/p>\n

\u2705 <\/span>\u589e\u52a0\u90e8\u5206<\/span><\/strong><\/p>\n


<\/span><\/p>\n

\u65b9\u6cd5\u9a8c\u8bc1\u5185\u5bb9\u5982\u4e0b\u3002<\/span><\/p>\n


<\/p>\n

\u4e8c\u3001\u51c6\u786e\u5ea6<\/span><\/strong><\/p>\n

4.\u6570\u636e\u8981\u6c42<\/span><\/strong><\/p>\n

\u7f8e\u56fd\u836f\u5178\u8bba\u575bPF39(6) <1200> Requirements For Compendial Validation \u4e2d\uff0c\u51c6\u786e\u5ea6\u53ef\u63a5\u53d7\u6807\u51c6\uff1a\u56de\u6536\u7387=100%\u00b12C-0.1505%\uff0c\u5176\u4e2dC\u4e3a\u5f85\u6d4b\u5b9a\u6210\u5206\u542b\u91cf\u3002<\/span><\/p>\n


<\/p>\n

\u4e09\u3001\u7cbe\u5bc6\u5ea6<\/span><\/strong><\/p>\n

4.\u6570\u636e\u8981\u6c42<\/span><\/strong><\/p>\n

\u5747\u5e94\u62a5\u544a\u504f\u5dee\u3001\u6807\u51c6\u504f\u5dee\u3001\u76f8\u5bf9\u6807\u51c6\u504f\u5dee\u6216\u7f6e\u4fe1\u533a\u95f4\u3002\u6837\u54c1\u4e2d\u5f85\u6d4b\u5b9a\u6210\u5206\u542b\u91cf\u548c\u7cbe\u5bc6\u5ea6<\/span>RSD<\/span>\u53ef\u63a5\u53d7\u8303\u56f4\u53c2\u8003\u88683<\/span>\uff08\u8ba1\u7b97\u516c\u5f0f\uff0c\u91cd\u590d\u6027\uff1aRSD r= C-0.15\uff1b\u91cd\u73b0\u6027\uff1aRSDR = 2C-0.15\uff0c\u5176\u4e2dC\u4e3a\u5f85\u6d4b\u5b9a\u6210\u5206\u542b\u91cf\uff09\uff0c\u53ef\u63a5\u53d7\u8303\u56f4\u53ef\u5728\u7ed9\u51fa\u6570\u503c0.5\uff5e2\u500d\u533a\u95f4\u3002<\/span><\/p>\n


<\/p>\n

\u2705 <\/span>\u4fee\u8ba2\u90e8\u5206<\/span><\/strong><\/p>\n


<\/span><\/strong><\/p>\n

3.\u8c03\u6574\u5185\u5bb9<\/span><\/strong><\/p>\n

\u836f\u54c1\u8d28\u91cf\u6807\u51c6<\/span>\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1<\/span>\uff08analytical method validation\uff09<\/span>\u7684\u76ee\u7684\u662f\u8bc1\u660e<\/span>\u91c7\u7528<\/span>\u5efa\u7acb<\/span>\u7684\u65b9\u6cd5\u9002\u5408\u4e8e\u76f8\u5e94\u68c0\u6d4b\u8981\u6c42\u3002<\/span>\u5728\u5efa\u7acb\u836f\u54c1\u8d28\u91cf\u6807\u51c6\u65f6\uff0c\u5206\u6790\u65b9\u6cd5\u9700\u7ecf\u9a8c\u8bc1\uff1b\u5728\u836f\u54c1\u751f\u4ea7\u5de5\u827a\u53d8\u66f4\u3001\u5236\u5242\u7684\u7ec4\u5206\u53d8\u66f4\u3001\u539f\u5206\u6790\u65b9\u6cd5\u8fdb\u884c\u4fee\u8ba2\u65f6\uff0c\u5219\u8d28\u91cf\u6807\u51c6\u5206\u6790\u65b9\u6cd5\u4e5f\u9700\u8fdb\u884c\u9a8c\u8bc1\u3002<\/span>\u5728\u5efa\u7acb\u836f\u54c1\u8d28\u91cf\u6807\u51c6\u3001\u53d8\u66f4\u836f\u54c1\u751f\u4ea7\u5de5\u827a\u6216\u5236\u5242\u7ec4\u5206\u3001\u4fee\u8ba2\u539f\u5206\u6790\u65b9\u6cd5\u65f6\uff0c\u9700\u5bf9\u5206\u6790\u65b9\u6cd5\u8fdb\u884c\u9a8c\u8bc1\u3002<\/span><\/p>\n


<\/p>\n

\u9a8c\u8bc1\u7684\u5206\u6790\u9879\u76ee\u6709\uff1a<\/span>\u9274\u522b\u8bd5\u9a8c\u3001\u9650\u91cf\u6216\u5b9a\u91cf\u68c0\u67e5\u3001\u539f\u6599\u836f\u6216\u5236\u5242\u4e2d\u6709\u6548\u6210\u5206\u542b\u91cf\u6d4b\u5b9a\uff0c\u4ee5\u53ca\u5236\u5242\u4e2d\u5176\u4ed6\u6210\u5206\uff08\u5982\u9632\u8150\u5242\u7b49\uff0c\u4e2d\u836f\u4e2d\u5176\u4ed6\u6b8b\u7559\u7269\u3001\u6dfb\u52a0\u5242\u7b49\uff09\u7684\u6d4b\u5b9a\u3002\u836f\u54c1\u6eb6\u51fa\u5ea6\u3001\u91ca\u653e\u5ea6\u7b49\u68c0\u67e5\u4e2d\uff0c\u5176\u6eb6\u51fa\u91cf\u7b49\u7684\u6d4b\u5b9a\u65b9\u6cd5\u4e5f\u5e94\u8fdb\u884c\u5fc5\u8981\u9a8c\u8bc1\u3002<\/span>\u9274\u522b\u8bd5\u9a8c\u3001\u6742\u8d28\u6d4b\u5b9a\uff08\u9650\u5ea6\u6216\u5b9a\u91cf\u5206\u6790\uff09\u3001\u542b\u91cf\u6d4b\u5b9a\u548c\u7279\u6027\u53c2\u6570\uff08\u5982\uff1a\u836f\u7269\u6eb6\u51fa\u5ea6\u3001\u91ca\u653e\u5ea6\u7b49\uff09\u3002<\/span><\/p>\n


<\/p>\n

\u9a8c\u8bc1\u7684\u6307\u6807\u6709\uff1a<\/span>\u4e13\u5c5e\u6027\u3001<\/span>\u51c6\u786e\u5ea6\u3001\u7cbe\u5bc6\u5ea6\uff08\u5305\u62ec\u91cd\u590d\u6027\u3001\u4e2d\u95f4\u7cbe\u5bc6\u5ea6\u548c\u91cd\u73b0\u6027\uff09<\/span>\u3001\u4e13\u5c5e\u6027\u3001<\/span>\u68c0\u6d4b\u9650\u3001\u5b9a\u91cf\u9650\u3001\u7ebf\u6027\u3001\u8303\u56f4\u548c\u8010\u7528\u6027\u3002<\/span><\/p>\n


<\/p>\n

\u4e09<\/span>\u4e00<\/span>\u3001<\/span><\/strong>\u4e13\u5c5e\u6027<\/strong><\/span><\/p>\n

\u4e13\u5c5e\u6027\u7cfb\u6307\u5728\u5176\u4ed6\u6210\u5206\uff08\u5982\u6742\u8d28<\/span>\u3001<\/span>\u964d\u89e3\u4ea7\u7269<\/span>\u3001\u8f85\u6599\u7b49\uff09<\/span>\u53ef\u80fd<\/span>\u5b58\u5728\u4e0b\uff0c\u91c7\u7528\u7684\u5206\u6790\u65b9\u6cd5\u80fd\u6b63\u786e\u6d4b\u5b9a\u51fa\u88ab\u6d4b\u7269\u7684\u80fd\u529b\u3002<\/span><\/p>\n


<\/p>\n

\u4e00<\/span>\u4e8c<\/span>\u3001\u51c6\u786e\u5ea6<\/strong><\/span><\/p>\n

\u51c6\u786e\u5ea6\u7cfb\u6307<\/span>\u91c7<\/span>\u7528<\/span>\u8be5<\/span>\u6240\u5efa\u7acb<\/span>\u65b9\u6cd5\u6d4b\u5b9a\u7684\u7ed3\u679c\u4e0e\u771f\u5b9e\u503c\u6216\u53c2\u6bd4\u503c\u63a5\u8fd1\u7684\u7a0b\u5ea6\uff0c\u4e00\u822c\u7528\u56de\u6536\u7387\uff08%\uff09\u8868\u793a\u3002\u51c6\u786e\u5ea6\u5e94\u5728\u89c4\u5b9a\u7684<\/span>\u7ebf\u6027<\/span>\u8303\u56f4\u5185<\/span>\u6d4b\u5b9a<\/span>\u8bd5\u9a8c<\/span>\u3002<\/span>\u51c6\u786e\u5ea6\u4e5f\u53ef\u7531\u6240<\/span>\u6d4b\u5b9a<\/span>\u7684\u7cbe\u5bc6\u5ea6\u3001\u7ebf\u6027\u548c\u4e13\u5c5e\u6027\u63a8\u7b97\u51fa\u6765\u3002<\/span><\/span><\/p>\n


<\/p>\n

1.\u5316\u5b66\u836f\u542b\u91cf\u6d4b\u5b9a\u65b9\u6cd5\u7684\u51c6\u786e\u5ea6<\/span><\/strong><\/p>\n

\u539f\u6599\u836f<\/span>\u91c7\u7528\u5bf9\u7167\u54c1<\/span>\u53ef\u7528\u5df2\u77e5\u7eaf\u5ea6\u7684\u5bf9\u7167\u54c1\u6216\u4f9b\u8bd5\u54c1<\/span>\u8fdb\u884c\u6d4b\u5b9a\uff0c\u6216\u7528<\/span>\u672c\u6cd5\u6240\u5f97<\/span>\u6240\u6d4b\u5b9a<\/span>\u7ed3\u679c\u4e0e\u5df2\u77e5\u51c6\u786e\u5ea6\u7684\u53e6\u4e00\u4e2a\u65b9\u6cd5\u6d4b\u5b9a\u7684\u7ed3\u679c\u8fdb\u884c\u6bd4\u8f83\u3002<\/span><\/p>\n

\u51c6\u786e\u5ea6\u4e5f\u53ef\u7531\u6240\u6d4b\u5b9a\u7684\u7cbe\u5bc6\u5ea6\u3001\u7ebf\u6027\u548c\u4e13\u5c5e\u6027\u63a8\u7b97\u51fa\u6765\u3002<\/span><\/p>\n


<\/p>\n

2.\u5316\u5b66\u836f\u6742\u8d28\u5b9a\u91cf\u6d4b\u5b9a\u7684\u51c6\u786e\u5ea6<\/span><\/strong><\/p>\n

\u53ef\u5411\u539f\u6599\u836f\u6216\u5236\u5242\u5904\u65b9\u91cf\u7a7a\u767d\u8f85\u6599\u4e2d\u52a0\u5165\u5df2\u77e5\u91cf\u6742\u8d28<\/span>\u5bf9\u7167\u54c1<\/span>\u8fdb\u884c\u6d4b\u5b9a\u3002\u5982\u4e0d\u80fd\u5f97\u5230\u6742\u8d28<\/span>\u6216\u964d\u89e3\u4ea7\u7269<\/span>\u5bf9\u7167\u54c1\uff0c\u53ef\u7528\u6240\u5efa\u7acb<\/span>\u7684<\/span>\u65b9\u6cd5\u6d4b\u5b9a<\/span>\u7684<\/span>\u7ed3\u679c\u4e0e\u53e6\u4e00\u6210\u719f\u7684\u65b9\u6cd5<\/span>\uff08\u5982\u836f\u5178\u6807\u51c6\u65b9\u6cd5\u6216\u7ecf\u8fc7\u9a8c\u8bc1\u7684\u65b9\u6cd5\uff09<\/span>\u8fdb\u884c\u6bd4\u8f83<\/span>\uff0c\u5982\u836f\u5178\u6807\u51c6\u65b9\u6cd5\u6216\u7ecf\u8fc7\u9a8c\u8bc1\u7684\u65b9\u6cd5<\/span>\u3002\u5728\u4e0d\u80fd\u6d4b\u5f97\u6742\u8d28<\/span>\u6216\u964d\u89e3\u4ea7\u7269<\/span>\u7684\u6821\u6b63\u56e0\u5b50\u6216\u4e0d\u80fd\u6d4b\u5f97\u5bf9\u4e3b\u6210\u5206\u7684\u76f8\u5bf9\u6821\u6b63\u56e0\u5b50\u7684\u60c5\u51b5\u4e0b\uff0c\u53ef\u7528<\/span>\u4e0d\u52a0\u6821\u6b63\u56e0\u5b50\u7684\u4e3b\u6210\u5206\u81ea\u8eab\u5bf9\u7167\u6cd5<\/span>\u4e3b\u6210\u5206\u7684\u6821\u6b63\u56e0\u5b50<\/span>\u8ba1\u7b97\u6742\u8d28\u542b\u91cf<\/span>\u3002<\/span>\uff0c\u5e76<\/span>\u5e94\u660e\u786e\u8868\u660e\u5355\u4e2a\u6742\u8d28\u548c\u6742\u8d28\u603b\u91cf\u76f8\u5f53\u4e8e\u4e3b\u6210\u5206\u7684\u91cd\u91cf\u6bd4\uff08%\uff09\u6216\u9762\u79ef\u6bd4\uff08%\uff09\u3002<\/span><\/p>\n


<\/p>\n

4.\u6570\u636e\u8981\u6c42<\/span><\/strong><\/p>\n

\u88682 \u6837\u54c1\u4e2d\u5f85\u6d4b\u5b9a\u6210\u5206\u542b\u91cf\u548c\u56de\u6536\u7387\u9650\u5ea6<\/span>*<\/span><\/p>\n

\"\u884c\u4e1a\u4fe1\u606f|2019\u5e743\u6708\u533b\u836f\u653f\u7b56\u6c47\u7f16\"<\/p>\n

*\u6b64\u8868\u6e90\u81eaAOAC\u300aGuidelines for Single Laboratory Validation of Chemical Methods for Dietary Supplements and Botanicals\u300b<\/span><\/p>\n


<\/p>\n

\u4e8c<\/span>\u4e09<\/span>\u3001\u7cbe\u5bc6\u5ea6<\/span><\/strong><\/p>\n

1.\u91cd\u590d\u6027<\/span><\/strong><\/p>\n

\u5728\u89c4\u5b9a\u8303\u56f4\u5185\uff0c\u53d6\u540c\u4e00\u6d53\u5ea6\uff08<\/span>\u5206\u6790\u65b9\u6cd5\u62df\u5b9a\u7684\u6837\u54c1\u6d4b\u5b9a\u6d53\u5ea6\uff0c<\/span>\u76f8\u5f53\u4e8e100%\u6d53\u5ea6\u6c34\u5e73\uff09\u7684\u4f9b\u8bd5\u54c1\uff0c\u7528\u81f3\u5c11\u6d4b\u5b9a6\u4efd\u7684\u7ed3\u679c\u8fdb\u884c\u8bc4\u4ef7\uff1b\u6216\u8bbe\u8ba13\u79cd\u4e0d\u540c\u6d53\u5ea6\uff0c\u6bcf\u79cd\u6d53\u5ea6\u5206\u522b\u5236\u59073\u4efd\u4f9b\u8bd5\u54c1\u6eb6\u6db2\u8fdb\u884c\u6d4b\u5b9a\uff0c\u75289\u4efd\u6837\u54c1\u7684\u6d4b\u5b9a\u7ed3\u679c\u8fdb\u884c\u8bc4\u4ef7\u3002\u91c7\u75289\u4efd\u6d4b\u5b9a\u7ed3\u679c\u8fdb\u884c\u8bc4\u4ef7\u65f6\uff0c<\/span>\u6d53\u5ea6\u7684\u8bbe\u5b9a\u5e94\u8003\u8651\u6837\u54c1\u7684\u6d53\u5ea6\u8303\u56f4<\/span>\u3002<\/span>\u5bf9\u4e8e\u5316\u5b66\u836f\uff0c\u4e00\u822c\u4e2d\u95f4\u6d53\u5ea6\u52a0\u5165\u91cf\u4e0e\u6240\u53d6\u4f9b\u8bd5\u54c1\u4e2d\u5f85\u6d4b\u5b9a\u6210\u5206\u91cf\u4e4b\u6bd4\u63a7\u5236\u57281:1\u5de6\u53f3\uff0c\u5efa\u8bae\u9ad8\u3001\u4e2d\u3001\u4f4e\u6d53\u5ea6\u5bf9\u7167\u54c1\u52a0\u5165\u91cf\u4e0e\u6240\u53d6\u4f9b\u8bd5\u54c1\u4e2d\u5f85\u6d4b\u5b9a\u6210\u5206\u91cf\u4e4b\u6bd4\u63a7\u5236\u57281.2:1\uff0c1:1\uff0c0.8:1\u5de6\u53f3\uff0c\u5bf9\u4e8e\u4e2d\u836f\uff0c\u4e00\u822c\u4e2d\u95f4\u6d53\u5ea6\u52a0\u5165\u91cf\u4e0e\u6240\u53d6\u4f9b\u8bd5\u54c1\u4e2d\u5f85\u6d4b\u5b9a\u6210\u5206\u91cf\u4e4b\u6bd4\u63a7\u5236\u57281:1\u5de6\u53f3\uff0c\u5efa\u8bae\u9ad8\u3001\u4e2d\u3001\u4f4e\u6d53\u5ea6\u5bf9\u7167\u54c1\u52a0\u5165\u91cf\u4e0e\u6240\u53d6\u4f9b\u8bd5\u54c1\u4e2d\u5f85\u6d4b\u5b9a\u6210\u5206\u91cf\u4e4b\u6bd4\u63a7\u5236\u57281.5:1\uff0c1:1\uff0c0.5:1\u5de6\u53f3\u3002<\/span><\/p>\n


<\/p>\n

\u4e09\u3001\u7cbe\u5bc6\u5ea6<\/span><\/strong><\/p>\n

4.\u6570\u636e\u8981\u6c42<\/span><\/strong><\/p>\n


<\/p>\n

\u88683 \u6837\u54c1\u4e2d\u5f85\u6d4b\u5b9a\u6210\u5206<\/span>\u7684<\/span>\u542b\u91cf<\/span>\u548c<\/span>\u4e0e<\/span>\u7cbe\u5bc6\u5ea6<\/span>RSD<\/span>\u53ef\u63a5\u53d7\u8303\u56f4<\/span>*<\/span><\/p>\n

\"\u884c\u4e1a\u4fe1\u606f|2019\u5e743\u6708\u533b\u836f\u653f\u7b56\u6c47\u7f16\"<\/p>\n

*\u6b64\u8868\u6e90\u81eaAOAC\u300aGuidelines for Single Laboratory Validation of Chemical Methods for Dietary Supplements and Botanicals\u300b<\/span><\/p>\n


<\/p>\n

\u53c2\u8003\u6587\u732e\uff1a<\/strong><\/p>\n


<\/span><\/p>\n

1\u3001\u5357\u4eac\u6b63\u5927\u5929\u6674\u7814\u7a76\u6240   <\/span>\u884c\u4e1a\u4fe1\u606f|2019\u5e743\u6708\u533b\u836f\u653f\u7b56\u96c6\u9526<\/span><\/p>\n

2\u3001GMP\u529e\u516c\u5ba4  <\/span>\u6b27\u76df\u53d1\u5e03\u300a\u706d\u83cc\u5de5\u827a\u6307\u5357\u300b\uff0c2019\u5e7410\u67081\u65e5\u8d77\u5b9e\u65bd\uff0c\u5c06\u53d6\u4ee3\u706d\u83cc\u51b3\u7b56\u6811\u6587\u4ef6<\/span><\/p>\n

3\u3001\u5199\u540c\u610f  <\/span>\u300a\u4e2d\u56fd\u836f\u5178\u300b2020\u5e74\u7248\u56db\u90e8\u589e\u4fee\u8ba2\u4e4b\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u6307\u5bfc\u539f\u5219<\/span><\/p>\n


<\/span><\/p>\n

<\/mpcps><\/section>\n<\/section>\n<\/section>\n<\/section><\/div>\n","protected":false},"excerpt":{"rendered":"

 \u4eff\u5236\u836f\u4e00\u81f4\u6027\u8bc4\u4ef7 \u5173\u4e8e\u53d1\u5e03\u5316\u5b66\u4eff\u5236\u836f\u53c2\u6bd4\u5236\u5242\u9074\u9009\u4e0e\u786e\u5b9a\u7a0b\u5e8f\u7684\u516c\u544a\uff082019\u5e74\u7b2c25\u53f7\uff09 NMPA\u53d1 […]<\/p>\n","protected":false},"author":1,"featured_media":81219,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[1],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/81218"}],"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=81218"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/81218\/revisions"}],"predecessor-version":[{"id":81230,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/81218\/revisions\/81230"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/81219"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=81218"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=81218"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=81218"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}