{"id":122971,"date":"2020-04-02T03:00:06","date_gmt":"2020-04-21T01:06:47","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/122971\/"},"modified":"2020-04-21T09:06:48","modified_gmt":"2020-04-21T01:06:48","slug":"da1b0da219","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/122971\/","title":{"rendered":"\u5fc5\u8bfb\uff01\u200b\u521b\u65b0\u836f\uff08\u5316\u5b66\u836f\uff09\u2162\u671f\u4e34\u5e8a\u8bd5\u9a8c\u836f\u5b66\u7814\u7a76\u4fe1\u606f\u6307\u5357"},"content":{"rendered":"
\n

\"\u5fc5\u8bfb\uff01\u200b\u521b\u65b0\u836f\uff08\u5316\u5b66\u836f\uff09\u2162\u671f\u4e34\u5e8a\u8bd5\u9a8c\u836f\u5b66\u7814\u7a76\u4fe1\u606f\u6307\u5357\"<\/p>\n

\"\u5fc5\u8bfb\uff01\u200b\u521b\u65b0\u836f\uff08\u5316\u5b66\u836f\uff09\u2162\u671f\u4e34\u5e8a\u8bd5\u9a8c\u836f\u5b66\u7814\u7a76\u4fe1\u606f\u6307\u5357\"
<\/p>\n

\u521b\u65b0\u836f\uff08\u5316\u5b66\u836f\uff09\u2162\u671f\u4e34\u5e8a\u8bd5\u9a8c\u836f\u5b66\u7814\u7a76\u4fe1\u606f\u6307\u5357<\/span><\/strong><\/span>
<\/p>\n

\u521b\u65b0\u836f\u836f\u5b66\u7814\u7a76\u968f\u7740\u7814\u53d1\u8fdb\u5c55\u7684\u4e0d\u65ad\u6df1\u5165\uff0c\u5728\u4e0d\u540c\u9636\u6bb5\u6709\u7740\u4e0d\u540c\u7684\u7814\u7a76\u76ee\u7684\u3002\u5728\u521b\u65b0\u836f\u4e34\u5e8a\u7814\u7a76\u671f\u95f4\uff0c\u63d0\u4f9b\u7684\u836f\u5b66\u7814\u7a76\u4fe1\u606f\u5e94\u91cd\u70b9\u5173\u6ce8\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u4e0e\u53d7\u8bd5\u8005\u5b89\u5168\u6027\u76f8\u5173\u7684\u90e8\u5206\uff0c\u7814\u7a76\u7684\u6df1\u5ea6\u548c\u5e7f\u5ea6\u4ee5\u53ca\u63d0\u4f9b\u4fe1\u606f\u91cf\u7684\u591a\u5c11\u9700\u8981\u7efc\u5408\u8003\u8651\u591a\u79cd\u56e0\u7d20\uff0c\u5305\u62ec\u836f\u7269\u81ea\u8eab\u7279\u70b9\u3001\u5242\u578b\u548c\u7ed9\u836f\u9014\u5f84\u3001\u7814\u53d1\u9636\u6bb5\u3001\u76ee\u6807\u4eba\u7fa4\u3001\u75be\u75c5\u7684\u7279\u70b9\u548c\u4e25\u91cd\u7a0b\u5ea6\u3001\u4e34\u5e8a\u8bd5\u9a8c\u5468\u671f\u7b49\u3002\u4e00\u822c\u800c\u8a00\uff0c<\/span>\u2162\u671f\u4e34\u5e8a\u7684\u7814\u7a76\u5468\u671f\u8f83\u957f\u3001\u53d7\u8bd5\u8005\u8f83\u591a\u3001\u4e34\u5e8a\u6837\u54c1\u9700\u6c42\u91cf\u8f83\u5927\uff0c\u540c\u65f6\u4f34\u968f\u7814\u7a76\u8fdb\u5c55\u6240\u83b7\u5f97\u7684\u836f\u5b66\u4fe1\u606f\u4e5f\u9010\u6e10\u4e30\u5bcc\uff0c\u8fd9\u51b3\u5b9a\u4e86\u8fdb\u5165<\/span>\u2162\u671f\u4e34\u5e8a\u8bd5\u9a8c\u6240\u9700\u63d0\u4f9b\u7684\u836f\u5b66\u7814\u7a76\u4fe1\u606f\u4e0d\u540c\u4e8e<\/span>\u2160\/\u2161\u671f\u4e34\u5e8a\u8bd5\u9a8c\u3002<\/span> <\/span><\/p>\n

\u7531\u4e8e\u836f\u54c1\u7684\u590d\u6742\u591a\u6837\u6027\uff0c\u672c\u6307\u5357\u65e8\u5728\u9610\u8ff0\u652f\u6301\u521b\u65b0\u836f\uff08\u5316\u5b66\u836f\uff09\u8fdb\u5165<\/span>\u2162\u671f\u4e34\u5e8a\u8bd5\u9a8c\u836f\u5b66\u7814\u7a76\u4fe1\u606f\u7684\u4e00\u822c\u6027\u8981\u6c42\u3002\u5982\u4e34\u5e8a\u6837\u54c1\u91c7\u7528\u975e\u5e38\u89c4\u751f\u4ea7\u5de5\u827a\u5236\u5907\uff0c\u53ef\u80fd\u9700\u63d0\u4f9b\u66f4\u8be6\u7ec6\u7684\u7814\u7a76\u4fe1\u606f\u3002<\/span> <\/span><\/p>\n

\u539f\u6599\u836f<\/span><\/strong><\/p>\n

S.1 <\/span><\/strong>\u57fa\u672c\u4fe1\u606f<\/span><\/strong><\/span><\/p>\n

S.1.1 \u836f\u54c1\u540d\u79f0<\/span> <\/span><\/p>\n

\u63d0\u4f9b\u539f\u6599\u836f\u547d\u540d\u7684\u76f8\u5173\u4fe1\u606f\uff1a<\/span>INN\uff08\u5982\u5df2\u62df\u5b9a\uff09\u3001\u4e2d\u6587\u901a\u7528\u540d\uff08\u5982\u5df2\u62df\u5b9a\uff09\u3001\u4e2d\u82f1\u6587\u5316\u5b66\u540d\u3001\u4ee3\u53f7\u3001\u5176\u4ed6\u540d\u79f0\u7b49\u3002<\/span> <\/span><\/p>\n

S.1.2 \u7ed3\u6784<\/span> <\/span><\/p>\n

\u63d0\u4f9b\u5df2\u9610\u660e\u7684\u539f\u6599\u836f\u7ed3\u6784\u4fe1\u606f\uff0c\u5982\u7ed3\u6784\u5f0f\uff08\u5e94\u5305\u62ec\u6210\u76d0\u548c\u6eb6\u5242\u5408\u7269\u6bd4\u4f8b\u3001\u624b\u6027<\/span>\/\u7acb\u4f53\u5316\u5b66\uff09\u3001\u5206\u5b50\u5f0f\u3001\u5206\u5b50\u91cf\u3002<\/span> <\/span><\/p>\n

S.1.3 \u57fa\u672c\u6027\u8d28<\/span> <\/span><\/p>\n

\u5217\u660e\u539f\u6599\u836f\u5173\u952e\u7684\u7406\u5316\u6027\u8d28\u53ca\u751f\u7269\u836f\u5242\u5b66\u6027\u8d28\uff0c\u5982\u6eb6\u89e3\u5ea6\u3001\u6e17\u900f\u6027\u3001<\/span>BCS\u5206\u7c7b\uff08\u5982\u5df2\u786e\u5b9a\uff09\u3001\u5f15\u6e7f\u6027\u3001\u89e3\u79bb\u5e38\u6570\uff08<\/span>pka\uff09\u3001\u5206\u914d\u7cfb\u6570\uff08<\/span>LogP\/LogD\uff09\u3001\u6676\u578b\u3001\u7b49\u7535\u70b9\u7b49\u3002<\/span> <\/span><\/p>\n

S.2 <\/span><\/strong>\u751f\u4ea7<\/span><\/strong><\/span><\/p>\n

S.2.1 \u751f\u4ea7\u5546<\/span> <\/span><\/p>\n

\u5217\u660e\u539f\u6599\u836f\u751f\u4ea7\u4e2d\uff08\u5305\u62ec\u751f\u4ea7\u3001\u68c0\u9a8c\u653e\u884c\uff09\u6d89\u53ca\u7684\u6240\u6709\u5382\u5546\u540d\u79f0\u548c\u5b8c\u6574\u5730\u5740\u3002\u5982\u6d89\u53ca\u591a\u4e2a\u751f\u4ea7\u5382\uff0c\u8fd8\u9700\u5217\u660e\u5404\u751f\u4ea7\u5382\u7684\u5177\u4f53\u804c\u8d23\u3002<\/span><\/p>\n

S.2.2 \u751f\u4ea7\u5de5\u827a\u548c\u8fc7\u7a0b\u63a7\u5236<\/span> <\/span><\/p>\n

\u63d0\u4f9b\u5408\u6210\u8def\u7ebf\u3001\u5de5\u827a\u6d41\u7a0b\u56fe\u4ee5\u53ca\u5de5\u827a\u63cf\u8ff0\u3002\u5de5\u827a\u63cf\u8ff0\u5efa\u8bae\u5305\u62ec\uff1a\uff08<\/span>1\uff09\u6279\u91cf\uff08\u8303\u56f4\uff09\uff1b\uff08<\/span>2\uff09\u5404\u7269\u6599\u6295\u6599\u6bd4\u4f8b\u3001\u5408\u6210\u64cd\u4f5c\u548c\u540e\u5904\u7406\u64cd\u4f5c\uff0c\u6ce8\u660e\u64cd\u4f5c\u6761\u4ef6<\/span>\/\u53c2\u6570\uff08\u5982\u65f6\u95f4\u3001\u6e29\u5ea6\uff09\u548c\u8fc7\u7a0b\u63a7\u5236\uff08\u7b80\u8981\u63cf\u8ff0\u5206\u6790\u65b9\u6cd5\uff09\uff0c\u5217\u660e\u7528\u5230\u7684\u6eb6\u5242\u3001\u8bd5\u5242\u3001\u50ac\u5316\u5242\u7b49\u3002<\/span> <\/span><\/p>\n

\u5982\u539f\u6599\u836f\u5236\u5907\u8fc7\u7a0b\u5305\u542b\u53d1\u9175\u5de5\u827a\u3001\u63d0\u53d6\u5de5\u827a\u3001\u591a\u80bd\u5408\u6210\u5de5\u827a\u3001\u5c0f\u5206\u5b50\u6838\u9178\u5236\u5907\u5de5\u827a\u7b49\uff0c\u9700\u63d0\u4f9b\u8bc1\u660e\u5de5\u827a\u7a33\u5b9a\u3001\u53ef\u63a7\u7684\u8be6\u7ec6\u4fe1\u606f\u3002<\/span><\/p>\n

\u5bf9\u4e8e\u65e0\u83cc\u539f\u6599\u836f\uff0c\u9700\u63d0\u4f9b\u706d\u83cc\u5de5\u827a\u548c\u65e0\u83cc\u4fdd\u8bc1\u63aa\u65bd\u3002<\/span><\/p>\n

S.2.3 \u7269\u6599\u63a7\u5236<\/span> <\/span><\/p>\n

\u6309\u7167\u5de5\u827a\u6d41\u7a0b\u56fe\u4e2d\u7684\u5de5\u5e8f\uff0c\u5217\u8868\u8bf4\u660e\u751f\u4ea7\u4e2d\u7528\u5230\u7684\u6240\u6709\u7269\u6599\uff08\u5982\u8d77\u59cb\u539f\u6599\u3001\u53cd\u5e94\u8bd5\u5242\u3001\u6eb6\u5242\u3001\u50ac\u5316\u5242\u7b49\uff09\uff0c\u8bf4\u660e\u5176\u8d28\u63a7\u4fe1\u606f\u3001\u4f7f\u7528\u6b65\u9aa4\u3002\u5bf9\u4e8e\u7531\u6240\u7528\u7269\u6599\u5f15\u5165\u7ec8\u4ea7\u54c1\u7684\u6742\u8d28\uff0c\u5305\u62ec\u5f02\u6784\u4f53\uff08\u5982\u9002\u7528\uff09\u3001\u6bd2\u6027\u6709\u673a\u6eb6\u5242<\/span>\/\u50ac\u5316\u5242\u3001\u6f5c\u5728\u9057\u4f20\u6bd2\u6027\u6742\u8d28\u548c\u751f\u7269\u5916\u6e90\u6027\u7269\u8d28\uff08\u5982\u9002\u7528\uff09\u7b49\uff0c\u9700\u8fdb\u884c\u63a7\u5236\u6216\u7ed3\u5408\u540e\u7eed\u6b65\u9aa4\u7684\u8f6c\u5316\u3001\u6e05\u9664<\/span><\/span>\u60c5\u51b5\u8fdb\u884c\u8bf4\u660e\u3002<\/span><\/p>\n

\u5efa\u8bae\u5bf9\u8d77\u59cb\u539f\u6599\u9009\u62e9\u7684\u5408\u7406\u6027\u8fdb\u884c\u8bf4\u660e\uff0c\u63d0\u4f9b\u8d77\u59cb\u539f\u6599\u4f9b\u5e94\u5546\u3001\u5236\u5907\u8def\u7ebf\u548c\u7b80\u8981\u5de5\u827a\u63cf\u8ff0\u4ee5\u53ca\u63a7\u5236\u6807\u51c6\uff08\u5305\u62ec\u68c0\u67e5\u9879\u76ee\u3001\u5206\u6790\u65b9\u6cd5\u63cf\u8ff0\u548c\u6682\u5b9a\u9650\u5ea6\uff09\u3002\u5bf9\u4e8e\u53d1\u9175\u6765\u6e90\u539f\u6599\u6216\u5929\u7136\u63d0\u53d6\u7269\u4f5c\u4e3a\u8d77\u59cb\u539f\u6599\uff0c\u8fd8\u9700\u63d0\u4f9b\u8be6\u7ec6\u8d44\u6599\u8bc1\u660e\u6f5c\u5728\u7684\u5f15\u8d77\u5b89\u5168\u6027\u62c5\u5fe7\u7684\u5176\u4ed6\u5916\u6e90\u6027\u7269\u8d28\uff08\u5982<\/span>TSE\/BSE\u53ca\u5176\u4ed6\u75c5\u6bd2\u3001\u7ec6\u83cc\u3001\u652f\u539f\u4f53\u3001\u771f\u83cc\u548c\u81f4<\/span><\/span>\u654f\u6027\u7269\u8d28\u7b49\uff09\u5f97\u5230\u63a7\u5236\u6216\u5728\u540e\u7eed\u5de5\u827a\u6b65\u9aa4\u4e2d\u88ab\u6e05\u9664\u3002<\/span><\/p>\n

S.2.4 \u5173\u952e\u6b65\u9aa4\u548c\u4e2d\u95f4\u4f53\u7684\u63a7\u5236<\/span> <\/span><\/p>\n

\u5982\u5df2\u786e\u5b9a\u751f\u4ea7\u7684\u5173\u952e\u6b65\u9aa4\uff0c\u9700\u5217\u51fa\u5173\u952e\u6b65\u9aa4\u53ca\u5176\u5de5\u827a\u53c2\u6570\u63a7\u5236\u8303\u56f4\u3002<\/span><\/p>\n

\u63d0\u4f9b\u5df2\u5206\u79bb\u7684\u4e2d\u95f4\u4f53\u7684\u63a7\u5236\u6807\u51c6\uff08\u5305\u62ec\u68c0\u67e5\u9879\u76ee\u3001\u5206\u6790\u65b9\u6cd5\u7b80\u8981\u63cf\u8ff0\u548c\u6682\u5b9a\u9650\u5ea6\uff09\u3002\u5fc5\u8981\u65f6\uff0c\u9700\u63d0\u4f9b\u5206\u6790\u65b9\u6cd5\u7684\u521d\u6b65\u9a8c\u8bc1\u4fe1\u606f\u3002<\/span><\/p>\n

S.2.5 \u5de5\u827a\u9a8c\u8bc1\u548c\u8bc4\u4ef7<\/span> <\/span><\/p>\n

\u4e0d\u9002\u7528\u3002<\/span><\/p>\n

S.2.6 \u751f\u4ea7\u5de5\u827a\u7684\u5f00\u53d1<\/span> <\/span><\/p>\n

\u63d0\u4f9b\u76f8\u5bf9\u4e8e<\/span>I\/II\u671f\u4e34\u5e8a\u6837\u54c1\u53ef\u80fd\u5f71\u54cd\u5230\u836f\u7269\u8d28\u91cf\u7684\u91cd\u5927\u5de5\u827a\u53d8\u66f4\uff0c\u63d0\u4f9b\u5177\u4f53\u53d8\u66f4\u5185\u5bb9\u548c\u53d8\u66f4\u524d\u540e\u7684\u76f8\u5173\u7814\u7a76\u4fe1\u606f\u4ee5\u53ca\u5fc5\u8981\u7684\u5b89\u5168\u6027\u98ce\u9669\u8bc4\u4f30\u3002<\/span> <\/span><\/p>\n

\u5bf9\u4e8e\u65e0\u83cc\u539f\u6599\u836f\uff0c\u5982\u539f\u6599\u836f\u65e0\u83cc\u751f\u4ea7\u5de5\u827a\u53d1\u751f\u53d8\u66f4\uff0c\u9700\u8be6\u7ec6\u63cf\u8ff0\u53d8\u66f4\u539f\u56e0\u3001\u53d8\u66f4\u5185\u5bb9\uff0c\u63d0\u4f9b\u53d8\u66f4\u7814\u7a76\u4fe1\u606f\u5e76\u5bf9\u53d8\u66f4\u7684\u5408\u7406\u6027\u8fdb\u884c\u8bf4\u660e\u3002<\/span><\/p>\n

S.3 <\/span><\/strong>\u7279\u6027\u9274\u5b9a<\/span><\/strong><\/span><\/p>\n

S.3.1 \u7ed3\u6784\u53ca\u5176\u4ed6\u7279\u6027<\/span> <\/span><\/p>\n

\u63d0\u4f9b\u786e\u8bc1\u539f\u6599\u836f\u7ed3\u6784\u7684\u7814\u7a76\u4fe1\u606f\uff0c\u4f8b\u5982\u5143\u7d20\u5206\u6790\u3001\u9ad8\u5206\u8fa8\u8d28\u8c31\u3001\u7ea2\u5916\u3001\u6838\u78c1\u3001\u7d2b\u5916\u3001\u8d28\u8c31\u3001\u5355\u6676<\/span>X\u884d\u5c04\uff08\u5982\u9002\u7528\uff09\u7b49\u3002\u5bf9\u4e8e\u591a\u80bd\u7c7b\u836f\u7269<\/span>\/\u6838\u9178\u7c7b\u836f\u7269\uff0c\u9700\u63d0\u4f9b\u5e8f\u5217\u6d4b\u5b9a\u3001\u6c28\u57fa\u9178<\/span>\/\u6838\u9178\u6bd4\u4f8b\u3001\u9ad8\u7ea7\u7ed3\u6784\u786e\u5b9a\u7b49\u4fe1\u606f\u3002\u9700\u63d0\u4f9b\u7ed3\u6784\u786e\u8bc1\u7528\u6837\u54c1\u4fe1\u606f\uff0c\u5177\u4f53\u6570\u636e\u3001\u56fe\u8c31\u4ee5\u53ca\u89e3\u6790\u8fc7\u7a0b\u3002<\/span> <\/span><\/p>\n

\u5982\u9002\u7528\uff0c\u63d0\u4f9b\u76d0\u578b\u3001\u7acb\u4f53\u6784\u578b\u3001\u6676\u578b\u3001\u7c92\u5ea6\u53ca\u5206\u5e03\u7814\u7a76\u4fe1\u606f\u3002<\/span><\/p>\n

S.3.2 \u6742\u8d28<\/span> <\/span><\/p>\n

\u5217\u8868\u8bf4\u660e\u6742\u8d28\u5206\u6790\u60c5\u51b5\uff0c\u5305\u62ec\u6742\u8d28\u540d\u79f0\u548c<\/span>\/\u6216\u4ee3\u53f7\u3001\u7ed3\u6784\u3001\u6765\u6e90\u3001\u662f\u5426\u8ba2\u5165\u6807\u51c6\u3001\u5b89\u5168\u6027\u652f\u6301\u9650\u5ea6\u7b49\u3002\u5bf9\u4e8e\u7ed3\u6784\u5c1a\u672a\u9610\u660e\u7684\u8d85\u8fc7\u9274\u5b9a\u9650\u5ea6\u7684\u6742\u8d28\uff0c\u4e5f\u9700\u63d0\u4f9b\u76f8\u5bf9\u4fdd\u7559\u65f6\u95f4\u3001\u662f\u5426\u5728\u6807\u51c6\u4e2d\u4f5c\u4e3a\u7279\u5b9a\u6742\u8d28\u63a7\u5236\u3001\u5b89\u5168\u6027\u652f\u6301\u9650\u5ea6\u7b49\u4fe1\u606f\u3002<\/span> <\/span><\/p>\n

\u5bf9\u4e8e\u5de5\u827a\u4e2d\u7528\u5230\u7684\u6eb6\u5242<\/span>\/\u50ac\u5316\u5242\u4f46\u672a\u8fdb\u884c\u5e38\u89c4\u63a7\u5236\u7684\uff0c\u9700\u8fdb\u884c\u5206\u6790\u8bf4\u660e\u3002<\/span> <\/span><\/p>\n

\u5bf9\u4e8e\u6f5c\u5728\u7684\u9057\u4f20\u6bd2\u6027\u6742\u8d28\uff0c\u9700\u63d0\u4f9b\u76f8\u5173\u7814\u7a76\u4fe1\u606f\uff08\u5982\u6765\u6e90\u3001\u7ed3\u6784\u3001\u63a7\u5236\u7b56\u7565\u7b49\uff09\u3002<\/span><\/p>\n

\u5982\u539f\u6599\u836f\u5236\u5907\u8fc7\u7a0b\u5305\u542b\u53d1\u9175\u6216\u63d0\u53d6\u6b65\u9aa4\uff0c\u8fd8\u9700\u63d0\u4f9b\u5de5\u827a\u4e2d\u6f5c\u5728\u7684\u5f15\u8d77\u5b89\u5168\u6027\u62c5\u5fe7\u7684\u5176\u4ed6\u5916\u6e90\u6027\u7269\u8d28\u7684\u5206\u6790\u9274\u522b\u3001\u6765\u6e90\u60c5\u51b5\uff0c\u5982\u75c5\u6bd2\uff08<\/span>TSE\/BSE\u7b49\uff09\u3001\u7ec6\u83cc\u3001\u652f\u539f\u4f53\u3001\u771f\u83cc\u548c\u81f4\u654f\u6027\u7269\u8d28\u7b49\u3002<\/span> <\/span><\/p>\n

S.4 <\/span><\/strong>\u8d28\u91cf\u63a7\u5236<\/span><\/strong><\/span><\/p>\n

S.4.1 \u8d28\u91cf\u6807\u51c6<\/span> <\/span><\/p>\n

\u4ee5\u8868\u683c\u5f62\u5f0f\u63d0\u4f9b\u539f\u6599\u836f\u7684\u8d28\u91cf\u6807\u51c6\uff0c\u5305\u62ec\u68c0\u6d4b\u9879\u76ee\u3001\u65b9\u6cd5\uff08\u53ef\u4ec5\u5217\u660e\u65b9\u6cd5\u79cd\u7c7b\uff0c\u5982<\/span>HPLC\u6cd5\uff09\u3001\u6682\u5b9a\u9650\u5ea6\u3002<\/span> <\/span><\/p>\n

\u65e0\u83cc\u5de5\u827a\u5236\u5242\u6240\u7528\u7684\u539f\u6599\u836f\u9700\u8fdb\u884c\u5fae\u751f\u7269\u63a7\u5236\u3002<\/span><\/p>\n

S.4.2 \u5206\u6790\u65b9\u6cd5<\/span> <\/span><\/p>\n

\u63d0\u4f9b\u5177\u4f53\u5206\u6790\u65b9\u6cd5\uff08\u5982\u91c7\u7528\u8272\u8c31\u65b9\u6cd5\uff0c\u9700\u660e\u786e\u8272\u8c31\u6761\u4ef6\uff09\u3002<\/span><\/p>\n

S.4.3 \u5206\u6790\u65b9\u6cd5\u7684\u9a8c\u8bc1<\/span> <\/span><\/p>\n

\u4ee5\u8868\u683c\u7684\u5f62\u5f0f\u603b\u7ed3\u65b9\u6cd5\u5b66\u9a8c\u8bc1\u7ed3\u679c\uff0c\u9700\u63d0\u4f9b\u5178\u578b\u56fe\u8c31\u3002\u5982\u9009\u62e9\u836f\u5178\u65b9\u6cd5\uff0c\u9700\u63d0\u4f9b\u836f\u5178\u65b9\u6cd5\u9002\u7528\u6027\u786e\u8ba4\u4fe1\u606f\u3002<\/span><\/p>\n

S.4.4 \u6279\u5206\u6790<\/span> <\/span><\/p>\n

\u66f4\u65b0\u6279\u5206\u6790\u6c47\u603b\uff0c\u5305\u62ec\u975e\u4e34\u5e8a\u5b89\u5168\u6027\u7814\u7a76\u6279\u6b21\u3001<\/span>\u2160\/\u2161\u671f\u4e34\u5e8a\u6837\u54c1\u6279\u6b21\u3001\u7a33\u5b9a\u6027\u6279\u6b21\u4ee5\u53ca\u53ef\u4ee3\u8868<\/span>\u2162\u671f\u4e34\u5e8a\u6837\u54c1\u7684\u6279\u6b21\u3002\u9700\u6ce8\u660e\u6279\u53f7\u3001\u6279\u91cf\u3001\u751f\u4ea7\u5de5\u827a\uff08\u53ef\u4ee5\u4ee3\u53f7\u8868\u793a\uff09\u3001\u751f\u4ea7\u5730\u70b9\u3001\u751f\u4ea7\u65e5\u671f\u3001\u7528\u9014\u3001\u5206\u6790\u65b9\u6cd5\uff08\u53ef\u4ee5\u7f16\u53f7\u6216\u7248\u672c\u53f7\u8868\u793a\uff09\u3001\u63a7\u5236\u9650\u5ea6\u4ee5\u53ca\u5b9e\u6d4b\u7ed3\u679c\u3002<\/span> <\/span><\/p>\n

\u63d0\u4f9b\u53ef\u4ee5\u4ee3\u8868<\/span>\u2162\u671f\u4e34\u5e8a\u6837\u54c1\u6279\u6b21\u7684\u68c0\u9a8c\u62a5\u544a\u3002<\/span> <\/span><\/p>\n

S.4.5 \u8d28\u91cf\u6807\u51c6\u5236\u5b9a\u4f9d\u636e<\/span> <\/span><\/p>\n

\u8bf4\u660e\u8d28\u91cf\u6807\u51c6\u4e2d\u7684\u9879\u76ee\u8bbe\u5b9a\u4ee5\u53ca\u5173\u952e\u9879\u76ee\uff08\u5982\u6742\u8d28\u3001\u53ef\u80fd\u5f71\u54cd\u5236\u5242\u6027\u80fd\u7684\u8d28\u91cf\u7279\u6027\uff09\u9650\u5ea6\u8bbe\u5b9a\u4f9d\u636e\u3002<\/span><\/p>\n

\u63d0\u4f9b\u76f8\u5bf9\u4e8e<\/span>\u2160\/\u2161\u671f\u4e34\u5e8a\u6837\u54c1\u8d28\u91cf\u6807\u51c6\uff0c<\/span>\u2162\u671f\u4e34\u5e8a\u6837\u54c1\u8d28\u91cf\u6807\u51c6\u53d8\u66f4\u7684\u5185\u5bb9\u3002\u5982\u6d89\u53ca\u8d28\u91cf\u6807\u51c6\u653e\u5bbd\uff08\u5982\u5220\u51cf\u68c0\u67e5\u9879\u76ee\u3001\u653e\u5bbd\u9650\u5ea6\u8981\u6c42\uff09\uff0c\u9700\u63d0\u4f9b\u53d8\u66f4\u539f\u56e0\u4ee5\u53ca\u53d8\u66f4\u4f9d\u636e\u3002\u5982\u6d89\u53ca\u6742\u8d28\u5206\u6790\u65b9\u6cd5\u7684\u91cd\u5927\u53d8\u66f4\uff0c\u9700\u63d0\u4f9b\u652f\u6301\u53d8\u66f4\u7684\u7814\u7a76\u4fe1\u606f\uff0c\u8bc4\u4f30\u65b9\u6cd5\u53d8\u66f4\u7684\u5408\u7406\u6027\u3002\u5fc5\u8981\u65f6\uff0c\u91c7\u7528\u53d8\u66f4\u524d\u3001\u540e\u65b9\u6cd5\u5bf9\u5b89\u5168\u6027\u7814\u7a76\u6279\u6b21\u91cd\u65b0\u6d4b\u5b9a\uff0c<\/span> <\/span><\/p>\n

\u8bc4\u4f30\u6742\u8d28\u9650\u5ea6\u7684\u5408\u7406\u6027\u3002<\/span><\/p>\n

S.5 <\/span><\/strong>\u5bf9\u7167\u54c1<\/span><\/strong><\/span><\/p>\n

\u5bf9\u4e8e\u81ea\u5236\u5bf9\u7167\u54c1\u5efa\u8bae\u63d0\u4f9b\u6765\u6e90\u3001\u5236\u5907\u6216\u7eaf\u5316\u65b9\u6cd5\u3001\u5fc5\u8981\u7684\u7ed3\u6784\u9274\u5b9a\u3001\u6807\u5316\u65b9\u6cd5\u548c\u6807\u5316\u7ed3\u679c\u3002\u5bf9\u4e8e\u5916\u8d2d\u5bf9\u7167\u54c1\uff0c\u9700\u8bf4\u660e\u6765\u6e90\u5e76\u63d0\u4f9b\u8bf4\u660e\u4e66\u548c\u6279\u53f7\u3002<\/span><\/p>\n

S.6 <\/span><\/strong>\u5305\u88c5\u7cfb\u7edf<\/span><\/strong><\/span><\/p>\n

\u63d0\u4f9b\u73b0\u91c7\u7528\u7684\u5305\u88c5\u6750\u6599\u548c\u5bb9\u5668\uff0c\u4e0e\u524d\u671f\u76f8\u6bd4\u5982\u6709\u91cd\u5927\u53d8\u66f4\uff0c\u9700\u8be6\u7ec6\u8bf4\u660e\u3002<\/span><\/p>\n

S.7 <\/span><\/strong>\u7a33\u5b9a\u6027<\/span><\/strong><\/span><\/p>\n

\u4ee5\u8868\u683c\u5f62\u5f0f\u63d0\u4f9b\u8fc4\u4eca\u83b7\u5f97\u7684\u652f\u6301\u5f00\u5c55<\/span>\u2162\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7684\u7a33\u5b9a\u6027\u7814\u7a76\u7ed3\u679c\uff0c\u5217\u660e\u7a33\u5b9a\u6027\u6279\u6b21\u7684\u6279\u53f7\u3001\u6279\u91cf\u3001\u751f\u4ea7\u5730\u70b9\u3001\u751f\u4ea7\u65e5\u671f\u3001\u6240\u7528\u5de5\u827a\uff08\u53ef\u4ee5\u4ee3\u53f7\u8868\u793a\uff09\uff0c\u5404\u7a33\u5b9a\u6027\u7814\u7a76\u4f7f\u7528\u7684\u5206\u6790\u65b9\u6cd5\uff08\u53ef\u4ee5\u7f16\u53f7\u6216\u7248\u672c\u53f7\u8868\u793a\uff09\u3002\u63d0\u4f9b\u5173\u952e\u9879\u76ee\uff08\u5982\u6709\u5173\u7269\u8d28\u7b49\uff09\u7684\u4ee3\u8868\u6027\u56fe\u8c31\uff08\u5982\u8d77\u70b9\u3001\u5df2\u5b8c\u6210\u6700\u957f\u65f6\u95f4\u70b9\u3001\u8d28\u91cf\u53d1\u751f\u660e\u663e\u53d8\u5316\u7684<\/span><\/span>\u65f6\u95f4\u70b9\u7b49\uff09\u3002<\/span><\/p>\n

\u5bf9\u7a33\u5b9a\u6027\u6570\u636e\u8fdb\u884c\u603b\u7ed3\uff0c\u53ef\u7ed3\u5408\u5f3a\u5236\u964d\u89e3\u8bd5\u9a8c\u5bf9\u4e8e\u53ef\u80fd\u7684\u964d\u89e3\u9014\u5f84\u8fdb\u884c\u8ba8\u8bba\u3002<\/span><\/p>\n

\u57fa\u4e8e\u7a33\u5b9a\u6027\u7814\u7a76\u7ed3\u679c\uff0c\u8bf4\u660e\u62df\u5b9a\u7684\u6709\u6548\u671f<\/span>\/\u590d\u9a8c\u671f\u548c\u8d2e\u5b58\u6761\u4ef6\u3002\u5982\u672a\u89c4\u5b9a\u6709\u6548\u671f<\/span>\/\u590d\u9a8c\u671f\uff0c\u5e94\u627f\u8bfa\u5236\u5242\u751f\u4ea7\u524d\u5bf9\u539f\u6599\u836f\u91cd\u65b0\u8fdb\u884c\u68c0\u9a8c\u3002<\/span> <\/span><\/p>\n

\u4e3a\u786e\u4fdd<\/span>NDA\u9636\u6bb5\u83b7\u5f97\u8db3\u591f\u7a33\u5b9a\u6027\u6570\u636e\uff0c\u5efa\u8bae\u63d0\u4f9b\u6b63\u5f0f\u7a33\u5b9a\u6027\u7814\u7a76\u65b9\u6848\u3002<\/span> <\/span><\/p>\n

\u5236\u5242<\/span><\/strong><\/p>\n

P.1 <\/span><\/strong>\u5242\u578b\u53ca\u4ea7\u54c1\u7ec4\u6210<\/span><\/strong><\/span><\/p>\n

\u4ee5\u5217\u8868\u65b9\u5f0f\u63d0\u4f9b<\/span>\u2162\u671f\u4e34\u5e8a\u6837\u54c1\u5355\u4f4d\u5242\u91cf\u7684\u5904\u65b9\u7ec4\u6210\uff0c\u660e\u786e\u8f85\u6599\u540d\u79f0\u3001\u7528\u91cf\u3001\u529f\u80fd\u53ca\u5176\u6267\u884c\u6807\u51c6\u3002\u5982\u7528\u5230\u9884\u6df7\u8f85\u6599\u9700\u660e\u786e\u5176\u7ec4\u6210\uff0c\u5bf9\u4e8e\u5305\u8863\u6750\u6599\u548c\u80f6\u56ca\u58f3\u5c3d\u53ef\u80fd\u660e\u786e\u5176\u7ec4\u6210\u3002\u5bf9\u4e8e\u5236\u5242\u4e2d\u7528\u5230\u4f46\u6700\u7ec8\u53bb\u9664\u7684\u6210\u5206\uff0c\u4e5f\u9700\u5217\u51fa\u3002\u5982\u9644\u5e26\u4e13\u7528\u6eb6\u5242\uff0c\u9700\u6309\u7167\u4e0a\u8ff0\u8981\u6c42\u63d0\u4f9b\u5176\u7ec4\u6210\u3002<\/span> <\/span><\/p>\n

\u5bf9\u4e8e\u7279\u6b8a\u5236\u5242\uff08\u6bd4\u5982\u7528\u5230\u7279\u5b9a\u7ed9\u836f\u88c5\u7f6e\u7684\u5438\u5165\u5236\u5242\u3001\u9f3b\u55b7\u5242\u7b49\uff09\uff0c<\/span>\u2162\u671f\u4e34\u5e8a\u6837\u54c1\u5904\u65b9\u548c\u7ed9\u836f\u88c5\u7f6e\u5e94\u4e0e\u5546\u4e1a\u5316\u4ea7\u54c1\u4fdd\u6301\u76f8\u4f3c\u3002<\/span> <\/span><\/p>\n

P.2 <\/span>\u4ea7\u54c1\u5f00\u53d1<\/span><\/span><\/strong><\/p>\n

\u7b80\u8981\u63cf\u8ff0\u5242\u578b\u3001\u89c4\u683c\u3001\u5904\u65b9\u3001\u5de5\u827a\u5f00\u53d1\u8fc7\u7a0b\u3002<\/span><\/p>\n

\u5bf9\u4e8e\u53d1\u751f\u836f\u5305\u6750\u76f8\u4e92\u4f5c\u7528\u98ce\u9669\u9ad8\u7684\u5236\u5242\uff08\u5982\u5438\u5165\u5236\u5242\u3001\u6ce8\u5c04\u5242\u3001\u773c\u7528\u5236\u5242\u4ee5\u53ca\u53e3\u670d\u6eb6\u6db2\u7b49\uff09\uff0c\u9700\u63d0\u4f9b\u5fc5\u8981\u7684\u76f8\u5bb9\u6027\u7814\u7a76\u4fe1\u606f\uff08\u5982\u53ef\u63d0\u53d6\u7269\u3001\u6d78\u51fa\u7269\u7b49\uff09\u3002<\/span> <\/span><\/p>\n

\u5bf9\u4e8e\u9700\u8981\u4e34\u7528\u73b0\u914d\u5236\u7684\u4ea7\u54c1\uff0c\u9700\u63d0\u4f9b\u76f8\u5173\u7684\u7a00\u91ca\u914d\u4f0d\u7a33\u5b9a\u6027\u7814\u7a76\u4fe1\u606f\u4ee5\u53ca\u914d\u5236\u65b9\u6cd5\u3002<\/span><\/p>\n

\u5bf9\u4e8e\u7279\u5b9a\u4eba\u7fa4\uff08\u5982\u513f\u7ae5\uff09\u7528\u836f\uff0c\u836f\u54c1\u6210\u5206\u3001\u5242\u578b\u548c\u7ed9\u836f\u88c5\u7f6e\uff08\u5982\u6709\uff09\u5e94\u5b89\u5168\uff0c\u5e76\u9002\u7528\u4e8e\u8be5\u7279\u5b9a\u4eba\u7fa4\u3002<\/span><\/p>\n

\u4e0e<\/span>\u2160\/\u2161\u671f\u4e34\u5e8a\u6837\u54c1\u76f8\u6bd4\uff0c\u5982\u5242\u578b\u3001\u5904\u65b9\u3001\u89c4\u683c\u53d1\u751f\u4e86\u53ef\u80fd\u5f71\u54cd\u5230\u4ea7\u54c1\u8d28\u91cf\u7279\u6027\uff08\u5982\u5f15\u8d77\u6742\u8d28\u8c31\u7684\u6539\u53d8\u3001\u5f71\u54cd\u5230\u4f53\u5185\u884c\u4e3a\u7b49\uff09\u7684\u91cd\u5927\u53d8\u66f4\uff0c\u9700\u8bf4\u660e\u5177\u4f53\u53d8\u66f4\u5185\u5bb9\u3001\u53d8\u66f4\u539f\u56e0\uff0c\u5e76\u6ce8\u610f\u8bc4\u4f30\u98ce\u9669\uff0c<\/span> <\/span><\/p>\n

\u89c6\u98ce\u9669\u7a0b\u5ea6\u5bf9\u53d8\u66f4\u524d\u540e\u6837\u54c1\u5f00\u5c55\u9002\u5f53\u7684\u4f53\u5916\u548c<\/span>\/\u6216\u4f53\u5185\u6865\u63a5\u7814\u7a76\u3002<\/span> <\/span><\/p>\n

\u4e0e<\/span>\u2160\/\u2161\u671f\u4e34\u5e8a\u6837\u54c1\u76f8\u6bd4\uff0c\u5982\u751f\u4ea7\u5de5\u827a\u53d1\u751f\u4e86\u53ef\u80fd\u5f71\u54cd\u5230\u4ea7\u54c1\u8d28\u91cf\u7279\u6027\u7684\u91cd\u5927\u53d8\u66f4\uff0c\u9700\u8bf4\u660e\u5177\u4f53\u53d8\u66f4\u5185\u5bb9\u3001\u53d8\u66f4\u539f\u56e0\uff0c\u5e76\u6ce8\u610f\u8bc4\u4f30\u98ce\u9669\uff0c\u89c6\u98ce\u9669\u7a0b\u5ea6\u5bf9\u53d8\u66f4\u524d\u540e\u6837\u54c1\u5f00\u5c55\u9002\u5f53\u7684\u4f53\u5916\u548c<\/span>\/\u6216\u4f53\u5185\u6865\u63a5\u7814\u7a76\u3002<\/span> <\/span><\/p>\n

\u5bf9\u4e8e\u65e0\u83cc\u5236\u5242\uff0c\u5982\u706d\u83cc\u5de5\u827a\u53d1\u751f\u53d8\u66f4\uff0c\u9700\u5bf9\u53d8\u66f4\u7684\u5408\u7406\u6027\u8fdb\u884c\u8bf4\u660e\u3002<\/span><\/p>\n

P.3 \u751f\u4ea7<\/span><\/span><\/strong><\/span> <\/span><\/strong><\/span><\/p>\n

P.3.1 \u751f\u4ea7\u5546<\/span> <\/span><\/p>\n

\u5217\u660e\u6240\u6709\u4e0e<\/span>\u2162\u671f\u4e34\u5e8a\u6837\u54c1\u751f\u4ea7\uff08\u5305\u62ec\u751f\u4ea7\u3001\u5305\u88c5\u3001\u68c0\u9a8c\u653e\u884c\uff09\u76f8\u5173\u7684\u5382\u5546\u540d\u79f0\u53ca\u5b8c\u6574\u5730\u5740\u3002\u5982\u6d89\u53ca\u591a\u4e2a\u751f\u4ea7\u5382\uff0c\u8fd8\u9700\u5217\u660e\u5404\u751f\u4ea7\u5382\u7684\u804c\u8d23\u3002<\/span> <\/span><\/p>\n

P.3.2 \u6279\u5904\u65b9<\/span> <\/span><\/p>\n

\u63d0\u4f9b<\/span>\u2162\u671f\u4e34\u5e8a\u6837\u54c1\u6279\u5904\u65b9\uff08\u5982\u53ef\u80fd\uff0c\u6ce8\u660e\u6279\u91cf\u6216\u6279\u91cf\u8303\u56f4\uff09\uff0c\u5217\u660e\u5404\u6210\u5206\u540d\u79f0\u3001\u7528\u91cf\u3002\u5982\u6709\u8fc7\u91cf\u52a0\u5165\u7684\u60c5\u51b5\u9700\u7ed9\u4e88\u8bf4\u660e\u3002\u5bf9\u4e8e\u5904\u65b9\u4e2d\u7528\u5230\u4f46\u6700\u7ec8\u9700\u53bb\u9664\u7684\u6eb6\u5242\u4e5f\u9700\u5217\u51fa\u3002<\/span> <\/span><\/p>\n

P.3.3 \u751f\u4ea7\u5de5\u827a\u548c\u8fc7\u7a0b\u63a7\u5236<\/span> <\/span><\/p>\n

\u63d0\u4f9b<\/span>\u2162\u671f\u4e34\u5e8a\u6837\u54c1\u7684\u751f\u4ea7\u5de5\u827a\u6d41\u7a0b\u56fe\u548c\u751f\u4ea7\u5de5\u827a\u63cf\u8ff0\uff0c\u4ee5\u53ca\u76f8\u5173\u7684\u8fc7\u7a0b\u63a7\u5236\u3002<\/span> <\/span><\/p>\n

\u5982\u91c7\u7528\u4e86\u975e\u5e38\u89c4\u751f\u4ea7\u5de5\u827a\uff0c\u9700\u8be6\u7ec6\u63cf\u8ff0\u3002<\/span><\/p>\n

\u5bf9\u4e8e\u65e0\u83cc\u5236\u5242\uff0c\u9700\u63d0\u4f9b\u8f83\u4e3a\u8be6\u7ec6\u7684\u706d\u83cc\u5de5\u827a\u53ca\u8fc7\u7a0b\u63a7\u5236\u3002<\/span><\/p>\n

P.3.4 \u5173\u952e\u6b65\u9aa4\u548c\u4e2d\u95f4\u4f53\u7684\u63a7\u5236<\/span> <\/span><\/p>\n

\u5982\u5df2\u786e\u5b9a\u751f\u4ea7\u7684\u5173\u952e\u6b65\u9aa4\uff0c\u9700\u63d0\u4f9b\u5173\u952e\u6b65\u9aa4\u7684\u5de5\u827a\u53c2\u6570\u63a7\u5236\u8303\u56f4\uff1b\u5982\u5df2\u5bf9\u5236\u5242\u4e2d\u95f4\u4f53\u8fdb\u884c\u63a7\u5236\uff0c\u9700\u63d0\u4f9b\u5176\u6807\u51c6\u3002<\/span><\/p>\n

\u5bf9\u4e8e\u5236\u5242\u4e2d\u95f4\u4f53\uff0c\u5982\u9700\u8d2e\u5b58\uff0c\u9700\u660e\u786e\u8d2e\u5b58\u6761\u4ef6\u548c\u53ef\u8d2e\u5b58\u65f6\u95f4\uff0c\u5fc5\u8981\u65f6\u63d0\u4f9b\u652f\u6301\u6027\u7814\u7a76\u7ed3\u679c\u3002<\/span><\/p>\n

P.3.5 \u5de5\u827a\u9a8c\u8bc1<\/span>\/\u8bc4\u4ef7<\/span> <\/span><\/p>\n

\u901a\u5e38\u4e0d\u9700\u8981\u63d0\u4f9b\u5de5\u827a\u9a8c\u8bc1\u4fe1\u606f\u3002\u5982\u91c7\u7528\u975e\u5e38\u89c4\u751f\u4ea7\u5de5\u827a\uff0c\u9700\u63d0\u4f9b\u8db3\u591f\u7684\u4fe1\u606f\u8bc4\u4f30\u5de5\u827a\u7684\u7a33\u5b9a\u6027\u548c\u53ef\u63a7\u6027\u3002\u5176\u4e2d\uff0c\u5982\u91c7\u7528\u975e\u5e38\u89c4\u706d\u83cc\u5de5\u827a\uff0c\u9700\u63d0\u4f9b\u8db3\u591f\u7684\u4fe1\u606f\u8bc4\u4f30\u4ea7\u54c1\u7684\u65e0\u83cc\u4fdd\u8bc1\u6c34\u5e73\u3002<\/span><\/p>\n

P.4 <\/span><\/strong>\u8f85\u6599\u63a7\u5236<\/span><\/strong><\/span><\/p>\n

\u5982\u6240\u7528\u8f85\u6599\u6267\u884c\u836f\u5178\u6807\u51c6\uff0c\u9700\u5217\u660e\u751f\u4ea7\u5546\u3001\u57fa\u672c\u4fe1\u606f\uff08\u5982\u578b\u53f7\u3001\u6765\u6e90\u3001\u7ec4\u5206\u7b49\uff09\u3001\u5177\u4f53\u6267\u884c\u7684\u836f\u5178\u6807\u51c6\uff08\u6bd4\u5982\u4e2d\u56fd\u836f\u5178<\/span>Ch.P\u3001\u7f8e\u56fd\u836f\u5178<\/span>USP\uff0c\u6b27\u6d32\u836f\u5178<\/span>Ph.Eur\uff0c\u65e5\u672c\u836f\u5178<\/span>JP\u7b49\uff09\u3002\u5982\u6240\u7528\u8f85\u6599\u6267\u884c\u5176\u4ed6\u884c\u4e1a\u6807\u51c6\u6216\u8005\u4f01\u4e1a\u6807\u51c6\uff0c\u9700\u5217\u660e\u5177\u4f53\u6807\u51c6\uff0c\u63cf\u8ff0\u4e3b\u8981\u9879\u76ee\u91c7\u7528\u7684\u65b9\u6cd5\u3002<\/span> <\/span><\/p>\n

\u5bf9\u4e8e\u56fd\u5185\u5916\u5236\u5242\u4e2d\u5c1a\u672a\u4f7f\u7528\u8fc7\u7684\u5168\u65b0\u8f85\u6599\uff0c\u5e94\u6309\u7167\u5173\u8054\u7533\u62a5\u8981\u6c42\u63d0\u4f9b\u76f8\u5173\u4fe1\u606f\u6216\u8005\u8fdb\u884c\u5173\u8054\u7533\u62a5\u3002<\/span><\/p>\n

\u5bf9\u4e8e\u4eba\u6e90<\/span>\/\u52a8\u7269\u6e90\u6027\u8f85\u6599\uff0c\u5e94\u58f0\u660e\u65e0\u5b89\u5168\u6027\u98ce\u9669\uff08\u5982<\/span>TSE\/BSE\u53ca\u5176\u4ed6\u75c5\u6bd2\u7b49\uff09\u3002<\/span><\/span><\/p>\n

P.5 <\/span><\/strong>\u8d28\u91cf\u63a7\u5236<\/span><\/strong><\/span><\/p>\n

P.5.1 \u8d28\u91cf\u6807\u51c6<\/span> <\/span><\/p>\n

\u4ee5\u8868\u683c\u5f62\u5f0f\u63d0\u4f9b\u5236\u5242\u7684\u653e\u884c\u6807\u51c6\u53ca\u8d27\u67b6\u671f\u6807\u51c6\uff08\u5982\u9002\u7528\uff09\uff0c\u5305\u62ec\u68c0\u6d4b\u9879\u76ee\u3001\u65b9\u6cd5\uff08\u53ef\u4ec5\u5217\u660e\u65b9\u6cd5\u79cd\u7c7b\uff0c\u5982<\/span>HPLC\u6cd5\uff09\u3001\u6682\u5b9a\u9650\u5ea6\u3002<\/span> <\/span><\/p>\n

\u901a\u5e38\uff0c\u68c0\u6d4b\u9879\u76ee\u81f3\u5c11\u5e94\u5305\u542b\u9274\u522b\u3001\u964d\u89e3\u4ea7\u7269\u548c\u542b\u91cf\u6d4b\u5b9a\u3002\u6b64\u5916\uff0c\u8fd8\u5e94\u5305\u542b\u9488\u5bf9\u5242\u578b\u7684\u7279\u5b9a\u68c0\u67e5\u9879\u76ee\u548c\u9650\u5ea6\u8981\u6c42\uff08\u5982\u53e3\u670d\u56fa\u4f53\u5236\u5242\u7684\u6eb6\u51fa\u5ea6<\/span>\/\u5d29\u89e3\u65f6\u9650\uff0c\u542b\u91cf\u5747\u5300\u5ea6\u68c0\u67e5\u7b49\uff1b\u6ce8\u5c04\u5242\u7684<\/span>pH\u503c\u3001\u7ec6\u83cc\u5185\u6bd2\u7d20\u548c\u65e0\u83cc\u68c0\u67e5\u7b49\uff09\u3002<\/span> <\/span><\/p>\n

\u5982\u9644\u5e26\u4e13\u7528\u6eb6\u5242\uff0c\u9700\u63d0\u4f9b\u4e13\u7528\u6eb6\u5242\u7684\u8d28\u91cf\u6807\u51c6\u3002<\/span><\/p>\n

P.5.2 \u5206\u6790\u65b9\u6cd5<\/span> <\/span><\/p>\n

\u63d0\u4f9b\u5177\u4f53\u5206\u6790\u65b9\u6cd5\uff08\u5982\u91c7\u7528\u8272\u8c31\u65b9\u6cd5\uff0c\u9700\u660e\u786e\u8272\u8c31\u6761\u4ef6\uff09\u3002<\/span><\/p>\n

P.5.3 \u5206\u6790\u65b9\u6cd5\u7684\u9a8c\u8bc1<\/span> <\/span><\/p>\n

\u4ee5\u8868\u683c\u7684\u5f62\u5f0f\u603b\u7ed3\u65b9\u6cd5\u5b66\u9a8c\u8bc1\u7ed3\u679c\uff0c\u9700\u63d0\u4f9b\u5178\u578b\u56fe\u8c31\u3002\u5982\u9009\u62e9\u836f\u5178\u65b9\u6cd5\uff0c\u9700\u63d0\u4f9b\u836f\u5178\u65b9\u6cd5\u9002\u7528\u6027\u786e\u8ba4\u4fe1\u606f\u3002<\/span><\/p>\n

P.5.4 \u6279\u5206\u6790<\/span> <\/span><\/p>\n

\u66f4\u65b0\u6279\u5206\u6790\u6c47\u603b\uff0c\u5305\u62ec\u975e\u4e34\u5e8a\u5b89\u5168\u6027\u7814\u7a76\u6279\u6b21\uff08\u5fc5\u8981\u65f6\uff09\u3001<\/span>\u2160\/\u2161\u671f\u4e34\u5e8a\u6837\u54c1\u6279\u6b21\u3001\u7a33\u5b9a\u6027\u6279\u6b21\u4ee5\u53ca\u53ef\u4ee3\u8868<\/span>\u2162\u671f\u4e34\u5e8a\u6837\u54c1\u7684\u6279\u6b21\u3002\u9700\u6ce8\u660e\u6279\u53f7\u3001\u6279\u91cf\u3001\u5904\u65b9\u5de5\u827a\uff08\u53ef\u4ee5\u4ee3\u53f7\u5f62\u5f0f\u63d0\u4f9b\uff09\u3001\u751f\u4ea7\u5730\u70b9\u3001\u751f\u4ea7\u65e5\u671f\u3001\u7528\u9014\u3001\u5206\u6790\u65b9\u6cd5\uff08\u53ef\u4ee5\u7f16\u53f7\u6216\u7248\u672c\u53f7\u5f62\u5f0f\u63d0\u4f9b\uff09\u3001\u63a7\u5236\u9650\u5ea6\u4ee5\u53ca\u5b9e\u6d4b\u7ed3\u679c\u3002<\/span> <\/span><\/p>\n

\u63d0\u4f9b\u53ef\u4ee3\u8868<\/span>\u2162\u671f\u4e34\u5e8a\u6837\u54c1\u6279\u6b21\u7684\u68c0\u9a8c\u62a5\u544a\u3002<\/span> <\/span><\/p>\n

P.5.5 \u6742\u8d28<\/span> <\/span><\/p>\n

\u63d0\u4f9b\u5236\u5242\u4e2d\u5b58\u5728\u4f46\u672a\u6db5\u76d6\u5728<\/span>S.3.2\u9879\u4e0b\u7684\u6742\u8d28\u4fe1\u606f\uff0c\u5305\u62ec\u6742\u8d28\u540d\u79f0\u548c<\/span>\/\u6216\u4ee3\u53f7\u3001\u7ed3\u6784\u3001\u964d\u89e3\u9014\u5f84\u3001\u5b89\u5168\u6027\u652f\u6301\u9650\u5ea6\u7b49\u3002\u5bf9\u4e8e\u7ed3\u6784\u5c1a\u672a\u9610\u660e\u7684\u8d85\u8fc7\u9274\u5b9a\u9650\u5ea6\u7684\u6742\u8d28\uff0c\u4e5f\u9700\u63d0\u4f9b\u76f8\u5bf9\u4fdd\u7559\u65f6\u95f4\u3001\u662f\u5426\u5728\u6807\u51c6\u4e2d\u4f5c\u4e3a\u7279\u5b9a\u6742\u8d28\u63a7\u5236\u3001\u5b89\u5168\u6027\u652f\u6301\u9650\u5ea6\u7b49\u4fe1\u606f\u3002<\/span> <\/span><\/p>\n

P.5.6 \u8d28\u91cf\u6807\u51c6\u5236\u5b9a\u4f9d\u636e<\/span> <\/span><\/p>\n

\u8bf4\u660e\u53ef\u80fd\u5f71\u54cd\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\u7684\u68c0\u6d4b\u9879\u76ee\u548c\u53ef\u63a5\u53d7\u9650\u5ea6\u7684\u8bbe\u5b9a\u4f9d\u636e\u3002<\/span><\/p>\n

\u5982\u4e0d\u5236\u5b9a\u9488\u5bf9\u5242\u578b\u7684\u5e38\u89c4\u68c0\u67e5\u9879\u76ee\uff0c\u9700\u8bf4\u660e\u5176\u5408\u7406\u6027\u3002<\/span><\/p>\n

\u8bf4\u660e\u76f8\u5bf9\u4e8e<\/span>\u2160\/\u2161\u671f\u4e34\u5e8a\u6807\u51c6\uff0c<\/span>\u2162\u671f\u4e34\u5e8a\u8d28\u91cf\u6807\u51c6\u53d8\u66f4\u7684\u5185\u5bb9\u3002\u5982\u6d89\u53ca\u8d28\u91cf\u6807\u51c6\u653e\u5bbd\uff08\u6bd4\u5982\u5220\u51cf\u68c0\u67e5\u9879\u76ee\u3001\u653e\u5bbd\u9650\u5ea6\u8981\u6c42\uff09\uff0c\u9700\u63d0\u4f9b\u53d8\u66f4\u539f\u56e0\u4ee5\u53ca\u53d8\u66f4\u4f9d\u636e\u3002\u5982\u7814\u7a76\u8fdb\u7a0b\u4e2d\u6d89\u53ca\u65b9\u6cd5\u91cd\u5927\u53d8\u66f4\uff0c\u9700\u63d0\u4f9b\u53d8\u66f4\u524d\u540e\u5fc5\u8981\u7684\u652f\u6301\u6027\u7814\u7a76\u4fe1\u606f\u3002<\/span> <\/span><\/p>\n

P.6 <\/span><\/strong>\u5bf9\u7167\u54c1<\/span><\/strong><\/span><\/p>\n

\u5bf9\u4e8e\u81ea\u5236\u5bf9\u7167\u54c1\u5efa\u8bae\u63d0\u4f9b\u6765\u6e90\u3001\u5236\u5907\u6216\u7eaf\u5316\u65b9\u6cd5\u3001\u5fc5\u8981\u7684\u7ed3\u6784\u9274\u5b9a\u3001\u6807\u5316\u65b9\u6cd5\u548c\u6807\u5316\u7ed3\u679c\u3002\u5bf9\u4e8e\u5916\u8d2d\u5bf9\u7167\u54c1\uff0c\u9700\u8bf4\u660e\u6765\u6e90\u5e76\u63d0\u4f9b\u8bf4\u660e\u4e66\u548c\u6279\u53f7\u3002\u5982<\/span>S.5\u4e2d\u5df2\u6db5\u76d6\uff0c\u53ef\u4e0d\u91cd\u590d\u63d0\u4f9b\u3002<\/span> <\/span><\/p>\n

P.7 <\/span><\/strong>\u5305\u88c5\u7cfb\u7edf<\/span><\/strong><\/span><\/p>\n

\u63d0\u4f9b<\/span>\u2162\u671f\u4e34\u5e8a\u6837\u54c1\u91c7\u7528\u7684\u5305\u88c5\u7cfb\u7edf\uff08\u5305\u62ec\u76f4\u63a5\u63a5\u89e6\u836f\u54c1\u7684\u5185\u5305\u88c5\u4ee5\u53ca\u5177\u6709\u529f\u80fd\u6027\u7684\u5916\u5305\u88c5\uff09\u4ee5\u53ca\u6267\u884c\u6807\u51c6\u3002<\/span> <\/span><\/p>\n

\u5bf9\u4e8e\u9ad8\u98ce\u9669\u5236\u5242\uff08\u5982\u5438\u5165\u5236\u5242\u3001\u6ce8\u5c04\u5242\u53ca\u773c\u7528\u5236\u5242\u7b49\uff09\u91c7\u7528\u7684\u5305\u88c5\u7cfb\u7edf\uff0c\u9700\u63d0\u4f9b\u6240\u6709\u7ec4\u4ef6\u7684\u751f\u4ea7\u5546\u3001\u6267\u884c\u6807\u51c6\u3002<\/span><\/p>\n

\u5bf9\u4e8e\u65b0\u6750\u6599\u3001\u65b0\u7ed3\u6784\u3001\u65b0\u7528\u9014\u7684\u836f\u5305\u6750\uff0c\u9700\u6309\u7167\u5173\u8054\u7533\u62a5\u8981\u6c42\u63d0\u4f9b\u76f8\u5173\u7814\u7a76\u4fe1\u606f\u6216\u8fdb\u884c\u5173\u8054\u7533\u62a5\u3002<\/span><\/p>\n

P.8 <\/span><\/strong>\u7a33\u5b9a\u6027<\/span><\/strong><\/span><\/p>\n

\u4ee5\u8868\u683c\u5f62\u5f0f\u63d0\u4f9b\u8fc4\u4eca\u83b7\u5f97\u7684\u652f\u6301\u5f00\u5c55<\/span>\u2162\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7684\u7a33\u5b9a\u6027\u7814\u7a76\u7ed3\u679c\uff0c\u5217\u660e\u7a33\u5b9a\u6027\u6279\u6b21\u7684\u6279\u53f7\u3001\u6279\u91cf\u3001\u751f\u4ea7\u5730\u70b9\u3001\u751f\u4ea7\u65e5\u671f\u3001\u5904\u65b9\u5de5\u827a\uff08\u53ef\u4ee5\u4ee3\u53f7\u8868\u793a\uff09\uff0c\u5404\u7a33\u5b9a\u6027\u7814\u7a76\u4f7f\u7528\u7684\u5206\u6790\u65b9\u6cd5\uff08\u53ef\u4ee5\u7f16\u53f7\u8868\u793a\uff09\u3002\u63d0\u4f9b\u5173\u952e\u9879\u76ee\uff08\u5982\u6709\u5173\u7269\u8d28\u7b49\uff09\u7684\u4ee3\u8868\u6027\u56fe\u8c31\uff08\u5982\u8d77\u70b9\u3001\u5df2\u5b8c\u6210\u6700\u957f\u65f6\u95f4\u70b9\u3001\u8d28\u91cf\u53d1\u751f\u660e\u663e\u53d8\u5316\u7684\u65f6\u95f4\u70b9\u7b49\uff09\u3002<\/span> <\/span><\/p>\n

\u57fa\u4e8e\u836f\u7269\u7279\u70b9\uff0c\u53ef\u80fd\u9700\u8981\u63d0\u4f9b\u9ad8\u6e29\u3001\u9ad8\u6e7f\u3001\u5149\u7167\u3001\u6c27\u5316\u4ee5\u53ca\u4f4e\u6e29<\/span>\/\u51bb\u878d\u8bd5\u9a8c\u6761\u4ef6\u4e0b\u7684\u7a33\u5b9a\u6027\u4fe1\u606f\u3002<\/span> <\/span><\/p>\n

\u57fa\u4e8e\u4ee5\u4e0a\u7814\u7a76\u7ed3\u679c\uff0c\u63d0\u51fa\u4e34\u5e8a\u6837\u54c1\u7684\u8d2e\u5b58\u6761\u4ef6\u3001\u62df\u5b9a\u7684\u6709\u6548\u671f\u548c\u6709\u6548\u671f\u5ef6\u957f\u8ba1\u5212\u3002<\/span><\/p>\n

\u5bf9\u4e8e\u4e34\u5e8a\u4e2d\u9700\u7a00\u91ca\u914d\u4f0d\u4f7f\u7528\u7684\u4ea7\u54c1\uff0c\u9700\u63d0\u4f9b\u7a00\u91ca\u914d\u4f0d\u7a33\u5b9a\u6027<\/span>\u7814\u7a76\u4fe1\u606f\uff1b<\/span>\u5bf9\u4e8e\u591a\u5242\u91cf\u5305\u88c5\uff08\u53e3\u670d\u56fa\u4f53\u5236\u5242\u9664\u5916\uff09\uff0c\u9700\u63d0\u4f9b\u5fc5\u8981\u7684\u5305\u88c5\u5f00\u542f\u540e\u7a33\u5b9a\u6027\u7814\u7a76\u4fe1\u606f\u3002<\/span>\u6b64\u90e8\u5206\u4fe1\u606f\u5e94\u80fd\u652f\u6301\u4e34\u5e8a\u65b9\u6848\u4e2d\u7684\u7528\u6cd5\u3002<\/span><\/p>\n

\u4e3a\u786e\u4fdd<\/span>NDA\u9636\u6bb5\u83b7\u5f97\u8db3\u591f\u7a33\u5b9a\u6027\u6570\u636e\uff0c\u5efa\u8bae\u63d0\u4f9b\u6b63\u5f0f\u7a33\u5b9a\u6027\u7814\u7a76\u65b9\u6848\u3002<\/span> <\/span><\/p>\n

\u5b89\u6170\u5242<\/span><\/p>\n

\u5982\u4e34\u5e8a\u8bd5\u9a8c\u65b9\u6848\u4e2d\u6d89\u53ca\u4f7f\u7528\u5b89\u6170\u5242\uff0c\u9700\u6309\u4ee5\u4e0a\u8981\u6c42\u63d0\u4f9b\u5b89\u6170\u5242\u7684\u751f\u4ea7\u5382\u3001\u5904\u65b9\u3001\u751f\u4ea7\u5de5\u827a\uff08\u9700\u5173\u6ce8\u540c\u4e34\u5e8a\u8bd5\u9a8c\u6837\u54c1\u5236\u5907\u7684\u5dee\u522b\uff09\u3001\u8d28\u91cf\u63a7\u5236\uff08\u8d28\u91cf\u6807\u51c6\u4e2d\u81f3\u5c11\u5e94\u5305\u62ec\u4e00\u9879\u53ef\u660e\u786e\u533a\u522b\u4e34\u5e8a\u8bd5\u9a8c\u836f\u54c1\u548c\u5b89\u6170\u5242\u7684\u68c0\u6d4b\u9879\u76ee\uff09\u3001\u5305\u88c5\u7cfb\u7edf\u4ee5\u53ca\u5fc5\u8981\u7684\u7a33\u5b9a\u6027\u7814\u7a76\u4fe1\u606f\u3002\u63d0\u51fa\u5b89\u6170\u5242\u7684\u8d2e\u5b58\u6761\u4ef6\u3001\u6709\u6548\u671f\u548c\u6709\u6548\u671f\u5ef6\u957f\u8ba1\u5212\uff08\u5982\u9002\u7528\uff09\u3002<\/span><\/p>\n

\u76f4\u63a5\u91c7\u7528\u4e0a\u5e02\u4ea7\u54c1\u4f5c\u4e3a\u5b89\u6170\u5242\u7684\uff08\u5982<\/span>0.9%\u6c2f\u5316\u94a0\u6ce8\u5c04\u6db2\uff09\uff0c\u65e0\u9700\u63d0\u4f9b\u989d\u5916\u4fe1\u606f\u3002<\/span> <\/span><\/p>\n

\u5bf9\u7167\u836f<\/span><\/p>\n

\u5982\u4e34\u5e8a\u8bd5\u9a8c\u65b9\u6848\u4e2d\u6d89\u53ca\u4f7f\u7528\u5bf9\u7167\u836f\uff0c\u6839\u636e\u4e34\u5e8a\u65b9\u6848\u8981\u6c42\u9700\u5bf9\u4e0a\u5e02\u4ea7\u54c1\u8fdb\u4e00\u6b65\u5904\u7406\u7684\uff08\u5982\u518d\u5305\u88c5\uff09\uff0c\u9700\u63d0\u4f9b\u5fc5\u8981\u7684\u5904\u7406\u4fe1\u606f\u3001\u8d28\u91cf\u7814\u7a76\u53ca\u7a33\u5b9a\u6027\u4fe1\u606f\uff0c\u539f\u5219\u4e0a\u5e94\u4fdd\u8bc1\u5904\u7406\u5bf9\u4ea7\u54c1\u8d28\u91cf\u65e0\u8d1f\u9762\u5f71\u54cd\u3002\u76f4\u63a5\u91c7\u7528\u4e0a\u5e02\u4ea7\u54c1\u4f5c\u4e3a\u5bf9\u7167\u836f\u7684\uff0c\u65e0\u9700\u63d0\u4f9b\u989d\u5916\u4fe1\u606f\u3002<\/span> <\/span><\/p>\n

\u540d\u8bcd\u89e3\u91ca<\/span><\/strong><\/p>\n

1.<\/span><\/strong>\u91cd\u5927\u53d8\u66f4\uff1a<\/span><\/strong>\u7814\u7a76\u8fdb\u7a0b\u4e2d\u53d1\u751f\u7684\u53ef\u80fd\u5f71\u54cd\u5230\u5b89\u5168\u6027\u6216\u4f53\u5185\u884c\u4e3a\u7684\u53d8\u66f4\uff0c\u793a\u4f8b\u5982\u4e0b\uff1a<\/span> <\/span><\/span><\/p>\n

\uff08<\/span>1\uff09\u539f\u6599\u836f\u751f\u4ea7\u65b9\u5f0f\u7684\u6539\u53d8\uff0c\u6bd4\u5982\u4ece\u53d1\u9175\u63d0\u53d6\u53d8\u4e3a\u5316\u5b66\u5408\u6210\u3002<\/span> <\/span><\/p>\n

\uff08<\/span>2\uff09\u5bf9\u4e8e\u5316\u5b66\u5408\u6210\u836f\u7269\uff0c\u539f\u6599\u836f\u5408\u6210\u8def\u7ebf\u6216\u5173\u952e\u7eaf\u5316\u5de5\u827a\u7684\u6539\u53d8\uff08\u5982\u6d89\u53ca\u6210\u952e\u53cd\u5e94\u7684\u7269\u6599\u53d8\u5316\u3001\u6700\u540e\u4e00\u6b65\u53cd\u5e94\u53ca<\/span>\/\u6216\u7ed3\u6676\u6b65\u9aa4\u6240\u7528\u6eb6\u5242\u7684\u6539\u53d8\u3001\u5bfc\u81f4\u6742\u8d28\u8c31\u53d8\u5316\u7684\u53d8\u66f4\uff09<\/span> <\/span><\/p>\n

\uff08<\/span>3\uff09\u5bf9\u4e8e\u53d1\u9175\u548c\u63d0\u53d6\u5de5\u827a\u5236\u5907\u836f\u7269\uff0c\u53ef\u80fd\u5f71\u54cd\u5230\u539f\u6599\u836f\u8d28\u91cf\u7684\u53d1\u9175\u5de5\u827a\u548c\u63d0\u53d6\u5de5\u827a\u7684\u53d8\u66f4\uff0c\u6bd4\u5982\u83cc\u79cd\u6539\u53d8\u3001\u5f71\u54cd\u5230\u6742\u8d28\u6e05\u9664\u7684\u6539\u53d8\u3002<\/span> <\/span><\/p>\n

\uff08<\/span>4\uff09\u539f\u6599\u836f\u6216\u5236\u5242\u706d\u83cc\u65b9\u6cd5\u7684\u6539\u53d8\u3002<\/span> <\/span><\/p>\n

\uff08<\/span>5\uff09\u5f71\u54cd\u5230\u5236\u5242\u8d28\u91cf\u7684\u5236\u5242\u5de5\u827a\u53d8\u5316\uff0c\u6bd4\u5982\u5e72\u6cd5\u5236\u7c92\u53d8\u4e3a\u6e7f\u6cd5\u5236\u7c92\u3002<\/span> <\/span><\/p>\n

\uff08<\/span>6\uff09\u5f71\u54cd\u5230\u5236\u5242\u8d28\u91cf\u7684\u5904\u65b9\u53d8\u5316\u3002<\/span> <\/span><\/p>\n

\uff08<\/span>7\uff09\u5242\u578b\u6539\u53d8\u3002<\/span> <\/span><\/p>\n

\uff08<\/span>8\uff09\u8d28\u91cf\u6807\u51c6\u9650\u5ea6\u653e\u5bbd\u3001\u68c0\u67e5\u9879\u76ee\u5220\u51cf\u3001\u5173\u952e\u8d28\u63a7\u9879\u76ee\u5206\u6790\u65b9\u6cd5\u663e\u8457\u6539\u53d8\u7b49\u3002<\/span> <\/span><\/p>\n

\uff08<\/span>9\uff09\u5f71\u54cd\u5230\u5236\u5242\u8d28\u91cf\uff08\u6bd4\u5982\u5b9a\u91cf\u51c6\u786e\u6027\u3001\u9012\u9001\u5242\u91cf\uff09\u7684\u5305\u88c5\u7cfb\u7edf\u7684\u6539\u53d8\u3002<\/span> <\/span><\/p>\n

2.<\/span><\/strong>\u975e\u5e38\u89c4\u751f\u4ea7\u5de5\u827a\uff1a<\/span><\/strong>\u5e94\u7ed3\u5408\u539f\u6599\u836f\u7684\u6027\u8d28\u3001\u5236\u5242\u7684\u6027\u8d28\u4ee5\u53ca\u5de5\u827a\u81ea\u8eab\u7279\u6027\u7b49\u6765\u786e\u5b9a\u662f\u5426\u4e3a\u975e\u5e38\u89c4\u751f\u4ea7\u5de5\u827a\u3002\u793a\u4f8b\u5982\u4e0b\uff1a<\/span> <\/span><\/span><\/p>\n

\uff08<\/span>1\uff09\u7279\u6b8a\u5236\u5242\u7684\u751f\u4ea7\uff0c\u6bd4\u5982\uff1a<\/span>\u2460\u5b9a\u91cf\u5438\u5165\u81f3\u80ba\u90e8\u7684\u6c14\u96fe\u5242\u548c\u7c89\u96fe\u5242\uff1b<\/span>\u2461\u975e\u5747\u76f8\u65e0\u83cc\u5236\u5242\uff1b<\/span>\u2462\u7f13\u91ca\u5236\u5242\uff1b<\/span>\u2463\u8f7d\u836f\u91cf\u4f4e\u4e8e<\/span>2%\u7684\u56fa\u4f53\u5236\u5242\u3002<\/span> <\/span><\/p>\n

\uff08<\/span>2\uff09\u5728\u5e38\u89c4\u5de5\u827a\u4e2d\u5f15\u5165\u67d0\u4e9b\u65b0\u6280\u672f\u3002<\/span> <\/span><\/p>\n

\uff08<\/span>3\uff09\u7279\u6b8a\u5de5\u827a\u548c\u590d\u6742\u5de5\u827a\uff0c\u6bd4\u5982\u5fae\u7247\u5236\u5907\u3001\u5e72\u538b\u5305\u8863\u3002<\/span> <\/span><\/p>\n

\uff08<\/span>4\uff09\u975e\u5e38\u89c4\u706d\u83cc\u5de5\u827a\uff0c\u6bd4\u5982\uff1a<\/span>\u2460\u91c7\u7528\u975e\u836f\u5178\u6536\u8f7d\u7684\u6e7f\u70ed\u7ec8\u7aef\u706d\u83cc\u6761\u4ef6\uff1b<\/span>\u2461\u91c7\u7528\u8f90\u5c04\u5242\u91cf\u4f4e\u4e8e<\/span>25 KGy\u7684\u8f90\u5c04\u7ec8\u7aef\u706d\u83cc\u3002<\/span> <\/span><\/p>\n

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

1. EMA\uff0c<\/span>2016\uff0c<\/span>Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials \uff08<\/span>draft\uff09<\/span>.<\/span><\/p>\n

2. FDA\uff0c<\/span>2003\uff0c<\/span>Guidance for Industry INDs for Phase 2 and Phase 3 Studies Chemistry\uff0c<\/span>Manufacturing\uff0c<\/span>and Controls Information.<\/span><\/p>\n

3. FDA\uff0c<\/span>1995\uff0c<\/span>Guidance for Industry Content and Format of Investigational New Drug Applications\uff08<\/span>INDs\uff09<\/span>for Phase 1 Studies of Drugs\uff0c<\/span>Including Well-Characterized\uff0c<\/span>Therapeutic\uff0c<\/span>Biotechnology-derived Products.<\/span><\/p>\n

4. FDA\uff0c<\/span>2008\uff0c<\/span>Guidance for Industry CGMP for Phase 1 Investigational Drugs.<\/span><\/p>\n

5. EMA\uff0c<\/span>2014\uff0c<\/span>Guideline on process validation for finished products information and data to be provided in regulatory submissions.<\/span><\/p>\n

6. ICH\uff0c<\/span>2014\uff0c<\/span>M7 Assessment and Control Of DNA Reactive \uff08<\/span>Mutagenic\uff09<\/span>Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk<\/span><\/p>\n

7.\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\uff0c\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\uff0c<\/span>2015 \u5e74\u7b2c<\/span> 3 \u53f7\u901a\u544a<\/span><\/span><\/p>\n

8.\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\uff0c\u300a\u5173\u4e8e\u53d1\u5e03\u836f\u5305\u6750\u836f\u7528\u8f85\u6599\u4e0e\u836f\u54c1\u5173\u8054\u5ba1\u8bc4\u5ba1\u6279\u6709\u5173\u4e8b\u9879\u7684\u516c\u544a\u300b\uff08<\/span>2016\u5e74\u7b2c<\/span>134\u53f7\uff09<\/span> <\/span><\/p>\n

9.\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\uff0c\u300a\u5173\u4e8e\u53d1\u5e03\u836f\u5305\u6750\u836f\u7528\u8f85\u6599\u7533\u62a5\u8d44\u6599\u8981\u6c42\uff08\u8bd5\u884c\uff09\u7684\u901a\u544a\u300b\uff08<\/span>2016 \u5e74\u7b2c<\/span> 155 \u53f7\uff09<\/span><\/span><\/p>\n

\u5236\u836f\u4eba\u624d\u7f51<\/span><\/strong>www.zhiyaojob.cn<\/span><\/strong><\/span><\/p>\n

\u8fd1\u671f\u804c\u4f4d\u63a8\u8350\uff0c\u5236\u836f\u4f01\u4e1a<\/span><\/strong><\/span><\/strong>\u514d\u8d39\u53d1\u5e03<\/span><\/strong><\/span><\/strong><\/span>\uff01<\/span><\/strong><\/span><\/strong><\/p>\n

\"\u5fc5\u8bfb\uff01\u200b\u521b\u65b0\u836f\uff08\u5316\u5b66\u836f\uff09\u2162\u671f\u4e34\u5e8a\u8bd5\u9a8c\u836f\u5b66\u7814\u7a76\u4fe1\u606f\u6307\u5357\"<\/p>\n

—<\/span>\u676d\u5dde\u65b0\u672c\u7acb\u533b\u836f\u62db\u8058\u52a9\u7406\u7814\u53d1\u5de5\u7a0b\u5e08\u3001\u7814\u53d1\u5de5\u7a0b\u5e08……<\/a><\/p>\n

—<\/span>\u957f\u6c99\u6676\u6613\u533b\u836f\u62db\u8058\u4e34\u5e8a\u533b\u5b66\u7ecf\u7406\u3001\u5206\u6790\u9879\u76ee\u8d1f\u8d23\u4eba\u3001\u5236\u5242\u9879\u76ee\u8d1f\u8d23\u4eba……<\/a><\/p>\n

—<\/span>\u6df1\u5733\u5e02\u8d1d\u7f8e\u836f\u4e1a\u62db\u8058\u4ea7\u54c1\u7ecf\u7406\u3001\u7814\u53d1\u9879\u76ee\u7ecf\u7406\u3001\u5546\u52a1BD\u62d3\u5c55\u4e13\u5458……<\/a><\/p>\n

—<\/span>\u5e7f\u4e1c\u4f17\u751f\u836f\u4e1a\u62db\u8058\u836f\u7269\u5236\u5242\u7814\u7a76\u5458\uff08\u9ad8\u7ea7\uff09\u3001\u4e34\u5e8a\u836f\u4ee3\u5206\u6790\u4e13\u5458\u3001\u836f\u7269\u8b66\u6212\u4e13\u5458……<\/a><\/p>\n

—<\/span>\u626c\u5b50\u6c5f\u836f\u4e1a\u62db\u8058\u5408\u6210\u7814\u7a76\u5458\u3001\u836f\u5b66\u8d28\u91cf\u7814\u7a76\u5458\u3001\u5236\u5242\u7814\u7a76\u5458……<\/a><\/p>\n

—<\/span>\u5e7f\u5dde\u4f70\u745e\u533b\u836f\u62db\u8058\u836f\u54c1\u6ce8\u518c\u4e13\u5458\/\u52a9\u7406\u3001\u9500\u552e\u4e13\u5458\u3001\u91c7\u8d2d\u4e3b\u7ba1……<\/a><\/p>\n

—<\/span>\u6d59\u6c5f\u5b5a\u8bfa\u533b\u836f\u62db\u8058\u9ad8\u7ea7\u7814\u53d1\u4eba\u5458\u3001\u533b\u5b66\u7ecf\u7406\u3001\u533a\u57df\u63a8\u5e7f\u7ecf\u7406……<\/a><\/p>\n

—<\/span>\u6e56\u5357\u6da6\u661f\u5236\u836f\u62db\u8058QA\u8d1f\u8d23\u4eba\u3001\u5de5\u7a0b\u8bbe\u5907\u8d1f\u8d23\u4eba\u3001\u9996\u5e2d\u7814\u53d1\u4e13\u5bb6……<\/a><\/p>\n

—<\/span>\u6da6\u8f89\u751f\u7269\u62db\u8058\u8d28\u91cf\u7814\u7a76\u5458\u3001QA\u7ecf\u7406……<\/a><\/p>\n

—<\/span>\u4e0a\u6d77\u8fd0\u5b8f\u5316\u5de5\u62db\u8058\u836f\u7528\u8f85\u6599\u9500\u552e\u4ee3\u8868\u3001\u9500\u552e\u52a9\u7406……<\/a><\/p>\n

—<\/span>\u6c5f\u82cf\u590d\u661f\u533b\u836f\u62db\u8058\u5730\u533a\u7ecf\u7406\u3001\u9500\u552e\u4ee3\u8868……<\/a><\/p>\n

—<\/span>\u6cf0\u4e30\u96c6\u56e2\u62db\u8058……<\/a><\/p>\n

—<\/span>\u79d1\u7b1b\u751f\u7269\u533b\u836f\u62db\u8058\u4ea7\u54c1\u6ce8\u518c\u603b\u76d1\/\u7ecf\u7406……<\/a><\/p>\n

—<\/span>\u5e7f\u5dde\u73bb\u601d\u97ec\u63a7\u91ca\u836f\u4e1a\u62db\u8058\u5546\u52a1\u62d3\u5c55\u7ecf\u7406\u3001\u5fae\u751f\u7269\u68c0\u9a8c\u3001\u751f\u7269\u68c0\u6d4b\u7814\u7a76\u5458……<\/a><\/p>\n

—<\/span>\u82cf\u5dde\u6717\u79d1\u751f\u7269\u62db\u8058\u836f\u7269\u5206\u6790\u603b\u76d1\u3001\u5236\u5242\u7814\u53d1\u603b\u76d1\u3001\u6709\u673a\u5408\u6210\u9ad8\u7ea7\u4e3b\u7ba1\/\u9879\u76ee\u4e3b\u7ba1……<\/a><\/p>\n

—<\/span>\u524d\u6cbf\u751f\u7269\u836f\u4e1a\u62db\u8058BD\u5b9e\u4e60\u751f\u3001\u6d77\u5916\u5e02\u573a\u4e13\u5458\u3001\u533a\u57df\u63a8\u5e7f\u7ecf\u7406\uff08\u5317\u4eac\uff09……<\/a><\/p>\n

—<\/span>\u4e0a\u6d77\u5b89\u5fc5\u751f\u5236\u836f\u62db\u8058\u5de5\u7a0b\u90e8\u7ecf\u7406\u3001\u751f\u4ea7\u5de5\u827a\u4e3b\u7ba1\u3001\u7814\u53d1QA……<\/a>
<\/p>\n

—<\/span>\u4e0a\u6d77\u535a\u552f\u751f\u7269\u62db\u8058\u4e34\u5e8a\u7814\u7a76\u5458\u3001\u52a9\u7406\u5de5\u7a0b\u5e08\uff08\u5236\u5242\uff09\u3001\u5b9e\u9a8c\u5458\uff08\u7eaf\u5316\uff09……<\/a><\/p>\n

—<\/span>\u957f\u6625\u6d77\u60a6\u836f\u4e1a\u62db\u8058\u836f\u7269\u5408\u6210\u7814\u7a76\u5458\u3001\u5236\u6c34\u3001\u9879\u76ee\u4e13\u5458……<\/a><\/p>\n

—<\/span>\u5409\u6797\u7701\u90fd\u90a6\u836f\u4e1a\u62db\u8058\u7814\u53d1\u5206\u6790\u4e3b\u7ba1\u3001\u5206\u6790\u7814\u7a76\u5458……<\/a><\/p>\n

—<\/span>\u5c1a\u79d1\u751f\u7269\u533b\u836f\u62db\u8058\u5206\u5b50\u751f\u7269\u5b66\u9ad8\u7ea7\u7814\u7a76\u5458\u3001\u9500\u552e\u7ecf\u7406\u3001\u836f\u7269\u5408\u6210\u5de5\u827a\u7814\u7a76\u5458……<\/a><\/p>\n

—<\/span>\u6d59\u6c5f\u6656\u77f3\u836f\u4e1a\u62db\u8058\u5de5\u827a\u5316\u5b66\u7814\u7a76\u5458……<\/a><\/p>\n

—<\/span>\u5929\u6d25\u7ea2\u65e5\u836f\u4e1a\u62db\u8058\u9500\u552e\u4ee3\u8868\u3001\u5730\u533a\u7ecf\u7406…..<\/a><\/p>\n

—<\/span>\u6d59\u6c5f\u534e\u6d77\u836f\u4e1a\u6ce8\u5c04\u5242\u7814\u7a76\u9662\u62db\u8058\u6ce8\u5c04\u5242\u7814\u53d1\u6280\u672f\u5458\/\u4e3b\u7ba1\/\u7ecf\u7406\/\u603b\u76d1……<\/a><\/p>\n

—<\/span>\u5eb7\u9f99\u5316\u6210\u65b0\u836f\u62db\u8058\u6709\u673a\u5408\u6210\u52a9\u7406\u7814\u7a76\u5458\u3001\u6709\u673a\u5408\u6210\u7814\u7a76\u5458\u3001\u9ad8\u7ea7\u6709\u673a\u5408\u6210\u7814\u7a76\u5458……<\/a><\/p>\n

—<\/span>\u661f\u938f\uff08\u4e0a\u6d77\uff09\u533b\u836f\u62db\u8058\u7814\u53d1QA\u4e13\u5458\u3001\u4e34\u5e8a\u4e0e\u836f\u54c1\u6ce8\u518c\u4e13\u5458\u3001\u6709\u673a\u5408\u6210\u7814\u7a76\u5458……<\/a><\/p>\n

—<\/span>\u5c71\u4e1c\u521b\u65b0\u836f\u7269\u7814\u53d1\u62db\u8058\u5236\u5242\u7814\u7a76\u5458\u3001\u5236\u5242\u9879\u76ee\u8d1f\u8d23\u4eba\u3001\u5206\u6790\u7814\u7a76\u5458……<\/a><\/p>\n

—<\/span>\u4e0a\u6d77\u5965\u79d1\u8fbe\u751f\u7269\u62db\u8058\u836f\u7269\u5236\u5242\u7814\u7a76\u5458\u3001\u9ad8\u7ea7\u836f\u7269\u5236\u5242\u7814\u7a76\u5458\u3001\u836f\u7269\u5206\u6790\u7814\u7a76\u5458……<\/a><\/p>\n

–\u676d\u5dde\u9752\u73a5\u533b\u836f\u62db\u8058\u5206\u6790\u7814\u7a76\u5458\u3001\u5408\u6210\u7814\u7a76\u5458\u3001\u5206\u6790\u7814\u7a76\u5458……<\/a>
<\/p>\n

—<\/span>\u5e7f\u5dde\u4ec1\u6052\u533b\u836f\u62db\u8058\u7535\u8bdd\u9500\u552e\u3001\u9500\u552e\u5b9e\u4e60\u751f\u3001\u5206\u6790\u7814\u7a76\u5458……<\/a><\/p>\n

—<\/span>\u6c5f\u82cf\u5409\u6cf0\u80bd\u4e1a\u62db\u8058QC\u3001\u5de5\u827a\u5458\u3001\u751f\u4ea7\u90e8GMP\u4e13\u5458……<\/a><\/p>\n

—<\/span>\u6e56\u5357\u6052\u5174\u533b\u836f\u62db\u8058QA\u3001\u5206\u6790\u7814\u7a76\u5458\u3001\u5206\u6790\u7814\u7a76\u4e3b\u7ba1……<\/a><\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

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