{"id":36133,"date":"2018-08-11T01:00:00","date_gmt":"2018-09-17T06:00:12","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/09\/17\/%e3%80%90%e5%a4%a7%e5%92%96%e8%b0%88%e3%80%91%e5%88%b6%e5%89%82%e5%bc%80%e5%8f%91%e4%b8%ad%ef%bc%8c%e5%88%86%e6%9e%90%e4%ba%ba%e5%91%98%e6%80%8e%e6%a0%b7%e6%8f%90%e5%8d%87%e8%87%aa%e5%b7%b1%ef%bc%9f\/"},"modified":"2018-09-17T14:00:15","modified_gmt":"2018-09-17T06:00:15","slug":"%e3%80%90%e5%a4%a7%e5%92%96%e8%b0%88%e3%80%91%e5%88%b6%e5%89%82%e5%bc%80%e5%8f%91%e4%b8%ad%ef%bc%8c%e5%88%86%e6%9e%90%e4%ba%ba%e5%91%98%e6%80%8e%e6%a0%b7%e6%8f%90%e5%8d%87%e8%87%aa%e5%b7%b1%ef%bc%9f","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/36133\/","title":{"rendered":"\u3010\u5927\u5496\u8c08\u3011\u5236\u5242\u5f00\u53d1\u4e2d\uff0c\u5206\u6790\u4eba\u5458\u600e\u6837\u63d0\u5347\u81ea\u5df1\uff1f"},"content":{"rendered":"
\n
\n

\u5206\u6790\u4eba\u5458\u5728\u5236\u5242\u7814\u7a76\u4e2d\u5e94\u505a\u597d\u54ea\u4e9b\u5de5\u4f5c\uff1f\u5982\u4f55\u5728\u770b\u4f3c\u67af\u71e5\u7684\u5de5\u4f5c\u4e2d\u63d0\u5347\u53d1\u5c55\u81ea\u5df1\uff1f\u521a\u521a\u4ece\u4e8b\u5206\u6790\u7684\u4eba\u5458\u4ece\u54ea\u4e9b\u65b9\u9762\u8fdb\u884c\u5207\u5165\uff1f\u4f5c\u8005\u7ed3\u5408\u6848\u4f8b\u548c\u5de5\u4f5c\u7ecf\u5386\u8fdb\u884c\u4e00\u4e2a\u7b80\u8981\u5206\u6790\uff0c\u629b\u7816\u5f15\u7389\uff0c\u6b22\u8fce\u8ba8\u8bba\uff01<\/span><\/p>\n<\/blockquote>\n

\u5206\u6790\u4eba\u5458\u5728\u5236\u5242\u7814\u7a76\u4e2d\u5e94\u505a\u597d\u54ea\u4e9b\u5de5\u4f5c\uff1f<\/span><\/strong><\/span><\/p>\n

1.<\/span>\u7814\u7a76<\/span>API<\/span>\u7684\u964d\u89e3\u9014\u5f84<\/span><\/span><\/strong><\/span><\/p>\n

\u62ff\u5230\u4e00\u4e2a\u65b0\u9879\u76ee\uff0c\u5728\u672a\u5f00\u59cb\u5177\u4f53\u8bd5\u9a8c\u524d\uff0c\u5e94\u68c0\u7d22\u53c2\u6bd4\u5236\u5242\u76f8\u5173\u4fe1\u606f\uff0c<\/span>API<\/span>\u4e2d\u82f1\u6587\u732e\u3001<\/span>FDA<\/span>\u8bc4\u4f30\u62a5\u544a\u3001\u65e5\u672c<\/span>IF<\/span>\u6587\u4ef6\u3001\u56fd\u5185\u5916\u836f\u5178\u8d28\u91cf\u6807\u51c6\uff0c\u5e76<\/span>\u5bf9\u6587\u732e\u4e2d<\/span>API<\/span>\u7684\u964d\u89e3\u6742\u8d28\u3001\u964d\u89e3\u9014\u5f84\u548c\u673a\u7406\u8fdb\u884c\u6c47\u603b<\/span><\/strong>\uff0c\u5305\u62ec\u56fa\u4f53\u72b6\u6001\u3001\u6eb6\u6db2\u72b6\u6001\u7b49\u591a\u79cd\u60c5\u51b5\u3002\u5982\u679c\u4e3a\u8854\u63a5\u524d\u4eba\u7684\u9879\u76ee\uff0c\u8fd8\u5e94\u5bf9\u5df2\u6709\u6570\u636e\u8fdb\u884c\u7cfb\u7edf\u5206\u6790\u548c\u603b\u7ed3\u3002<\/span><\/span><\/p>\n

\u4f8b\u5982\u6839\u636e\u6587\u732e\u62a5\u9053\uff0c\u6c28\u6c2f\u5730\u5e73\u5728\u5149\u7167\u3001\u6c27\u5316\u6761\u4ef6\u4e0b\u4f1a\u4ea7\u751f\u76f8\u540c\u7684\u964d\u89e3\u6742\u8d28\uff08\u89c1\u56fe<\/span>1<\/span>\uff09\u3002<\/span><\/span><\/p>\n

\"\u3010\u5927\u5496\u8c08\u3011\u5236\u5242\u5f00\u53d1\u4e2d\uff0c\u5206\u6790\u4eba\u5458\u600e\u6837\u63d0\u5347\u81ea\u5df1\uff1f\"\u56fe<\/span>1. <\/span>\u6c28\u6c2f\u5730\u5e73\u7684\u964d\u89e3\u9014\u5f84\u548c\u964d\u89e3\u6742\u8d28<\/span>
<\/span><\/p>\n

\u5728\u5bf9\u4e0d\u540c\u6eb6\u51fa\u66f2\u7ebf\u8fdb\u884c\u8003\u5bdf\u65f6\uff0c\u4f1a\u9047\u5230\u4e0d\u540c<\/span>pH<\/span>\u503c\u7684\u6eb6\u6db2\uff0c<\/span>\u4f9b\u8bd5\u54c1\u5728\u4e0d\u540c<\/span>pH<\/span>\u503c\u6eb6\u6db2\u4e2d\u7684\u7a33\u5b9a\u6027\u5982\u4f55\uff1f<\/span><\/strong>\u8fd9\u4e9b\u9700\u8981\u8fdb\u884c\u8003\u5bdf\uff0c\u91c7\u7528<\/span>API<\/span>\u8fdb\u884c\u8003\u5bdf\u5373\u53ef\u3002\u6709\u65f6<\/span>API<\/span>\u5728\u5bf9\u7167\u54c1\u6eb6\u6db2\u4e2d\u7684\u7a33\u5b9a\u6027\u4e5f\u9700\u8981\u7814\u7a76\uff08\u89c1\u56fe<\/span>2<\/span>\uff09\u3002<\/span><\/span><\/p>\n

\u5982\u679c\u5236\u5242\u5de5\u827a\u4e2d\u91c7\u7528\u4e86\u6e7f\u6cd5\u5236\u7c92\u3001\u9ad8\u6e29\u5e72\u71e5\u3001\u5fae\u5206\u5316\u7b49\u5de5\u827a\uff0c\u90a3\u4e48<\/span>API<\/span>\u5728\u8fd9\u4e9b\u6761\u4ef6\u4e0b\u6709\u65e0\u964d\u89e3\uff0c\u5176\u4e2d\u67d0\u79cd\u6c34\u89e3\u6742\u8d28\u662f\u5426\u6709\u589e\u52a0\uff0c\u6676\u578b\u5728\u6eb6\u89e3\u6216\u5e72\u71e5\u7684\u8fc7\u7a0b\u4e2d\u6709\u65e0\u6676\u578b\u7684\u8f6c\u5316\uff0c\u8fd9\u4e9b\u90fd\u662f\u8981\u5206\u6790\u4eba\u5458\u8981\u4e86\u89e3\u7684\u3002\u5f53\u5de5\u827a\u4e2d\u53ef\u80fd\u4f1a\u63a5\u89e6\u6e7f\u3001\u70ed\u3001\u5149\u7167\u7b49\u4e0e\u6761\u4ef6\u65f6\uff0c\u5e94\u5bf9\u4e2d\u95f4\u4ea7\u54c1\u6216\u4e2d\u95f4\u4f53\u7684\u8d2e\u85cf\u65f6\u95f4\u3001\u8d2e\u85cf\u6761\u4ef6\u8fdb\u884c\u8003\u5bdf\uff0c\u638c\u63e1\u5176\u964d\u89e3\u7a0b\u5ea6\u3001\u6761\u4ef6\u7684\u654f\u611f\u6027\uff0c\u91c7\u7528\u597d\u5fc5\u8981\u7684\u4fdd\u62a4\u63aa\u65bd\u3002<\/strong><\/span><\/span><\/p>\n

\"\u3010\u5927\u5496\u8c08\u3011\u5236\u5242\u5f00\u53d1\u4e2d\uff0c\u5206\u6790\u4eba\u5458\u600e\u6837\u63d0\u5347\u81ea\u5df1\uff1f\"<\/p>\n

\u56fe<\/span>2.  <\/span>\u6c28\u6c2f\u5730\u5e73\u7684\u4e59\u9187\u6eb6\u6db2\u5149\u7a33\u5b9a\u6027\u8003\u5bdf<\/span>
<\/span><\/span><\/p>\n

\u5728\u5bf9\u964d\u89e3\u6742\u8d28\u3001\u964d\u89e3\u9014\u5f84\u8fdb\u884c\u7814\u7a76\u65f6\u6240\u91c7\u7528\u7684\u65b9\u6cd5\u5e94\u5177\u6709\u8f83\u597d\u7684\u4e13\u5c5e\u6027<\/span><\/strong>\uff0c\u5728\u5236\u5242\u5904\u65b9\u5f00\u53d1\u65e9\u671f\uff0c\u53ef\u5728\u6742\u8d28\u8c31\u5206\u6790\u7684\u57fa\u7840\u4e0a\u9009\u62e9\u836f\u5178\u6216\u6587\u732e\u4e2d\u6bd4\u8f83\u6210\u719f\u7684\u65b9\u6cd5\u3002<\/span><\/span><\/p>\n

\u8fdb\u884c\u964d\u89e3\u9014\u5f84\u7814\u7a76\u4e2d\uff0c\u5e94\u91cd\u70b9\u5173\u6ce8\u6216\u786e\u8ba4\u5728\u67d0\u79cd\u6761\u4ef6\u4e0b\u7684\u964d\u89e3\u60c5\u51b5\u4e0e\u56fd\u5185\u6587\u732e\u662f\u5426\u4e00\u81f4\uff0c<\/span><\/strong>\u5982\u6c27\u5316\u3001\u9178\u78b1\u6c34\u89e3\u3001\u5149\u7167\u3001\u9ad8\u6e29\u3001\u9ad8\u6e29<\/span>+<\/span>\u9ad8\u6e7f\u7b49\u6761\u4ef6\u3002\u5982\u6839\u636e\u539f\u8f85\u6599\u76f8\u5bb9\u6027\u57fa\u672c\u539f\u7406\u5206\u6790\uff0c\u6709\u53ef\u80fd\u5b58\u5728\u76f8\u4e92\u4f5c\u7528\uff0c\u90a3\u4e48\u5e94\u8be5\u9009\u62e9\u51fa\u6070\u5f53\u7684\u68c0\u6d4b\u65b9\u6cd5\uff0c\u5982\u6c28\u6c2f\u5730\u5e73<\/span>USP<\/span>\u65b9\u6cd5\u5c31\u53ef\u4ee5\u68c0\u6d4b\u4e73\u7cd6\u3001\u8461\u8404\u7cd6\u3001\u534a\u4e73\u7cd6\u548c\u6c28\u6c2f\u5730\u5e73\u7684\u52a0\u5408\u7269\uff08\u89c1\u8868<\/span>1<\/span>\uff09\uff0c\u8fd9\u4e9b\u6742\u8d28\u4e0e\u6240\u91c7\u7528\u7684\u5904\u65b9\u6709\u5173\uff0c\u5982\u679c\u6709\u7684\u6807\u51c6\u4e2d\u6ca1\u6709\u89c4\u5b9a\u8fd9\u4e9b\u6742\u8d28\uff0c\u8bf4\u660e\u53ef\u80fd\u6ca1\u6709\u91c7\u7528\u4e73\u7cd6\u7b49\u8f85\u6599\uff0c\u56e0\u6b64<\/span>\u5236\u5242\u7684\u6742\u8d28\u5206\u6790\u4e0e<\/span>API<\/span>\u662f\u6709\u4e00\u5b9a\u5dee\u5f02\u7684\uff0c\u9700\u8981\u7ed3\u5408\u5904\u65b9\u5de5\u827a\u751a\u81f3\u52a0\u901f\u957f\u671f\u8bd5\u9a8c\u7ed3\u679c\u4e00\u8d77\u53bb\u5206\u6790<\/span><\/strong>\uff08\u89c1\u56fe<\/span>3<\/span>\uff09\u3002<\/span><\/span><\/p>\n

\u8868<\/span>1.  USP<\/span>\u6c28\u6c2f\u5730\u5e73\u7247\u6709\u5173\u7269\u8d28\u9650\u5ea6\u8868<\/span><\/span><\/p>\n

\"\u3010\u5927\u5496\u8c08\u3011\u5236\u5242\u5f00\u53d1\u4e2d\uff0c\u5206\u6790\u4eba\u5458\u600e\u6837\u63d0\u5347\u81ea\u5df1\uff1f\"<\/p>\n

\"\u3010\u5927\u5496\u8c08\u3011\u5236\u5242\u5f00\u53d1\u4e2d\uff0c\u5206\u6790\u4eba\u5458\u600e\u6837\u63d0\u5347\u81ea\u5df1\uff1f\"<\/strong><\/span>
<\/p>\n

\u56fe<\/span>3. <\/span>\u5965\u7f8e\u6c99\u5766\u916f\u7247\u52a0\u901f<\/span>6<\/span>\u6708\u964d\u89e3\u6742\u8d28<\/span>DP-1<\/span>\u7814\u7a76\u56fe\u8c31<\/span>
<\/span><\/p>\n

\u5728<\/span>API<\/span>\u7684\u964d\u89e3\u9014\u5f84\u7814\u7a76\u9636\u6bb5\uff0c\u5bf9\u6587\u732e\u68c0\u7d22\u662f\u5426\u5168\u9762\uff1f\u7406\u89e3\u4e0e\u628a\u63e1\u662f\u5426\u5230\u4f4d\uff1f\u975e\u5e38\u91cd\u8981\uff0c\u4e0d\u4ec5\u8981\u6c42\u5206\u6790\u4eba\u5458\u8981\u5177\u6709\u8f83\u9ad8\u7684\u68c0\u7d22\u80fd\u529b\uff0c\u66f4\u9700\u8981\u5177\u6709\u8f83\u9ad8\u7684\u82f1\u6587\u9605\u8bfb\u80fd\u529b\u3001\u903b\u8f91\u5206\u6790\u80fd\u529b\u3002<\/strong>\u4e0d\u8981\u4ec5\u4ec5\u4ece<\/span>\u201c<\/span>\u68c0\u6d4b\u6837\u54c1<\/span>\u201d<\/span>\u7684\u89d2\u5ea6\u53bb\u8003\u8651\u95ee\u9898\uff0c\u9700\u8981\u7ad9\u5728\u6574\u4e2a\u9879\u76ee\u7684\u5b8f\u89c2\u89d2\u5ea6\uff0c<\/span>\u201c<\/span>\u8d28\u91cf\u7814\u7a76<\/span>\u201d<\/span>\u7684\u89d2\u5ea6\u53bb\u8003\u8651\u95ee\u9898\uff0c\u9700\u8981\u4e3b\u52a8\u914d\u5408\u5236\u5242\u8fdb\u884c\u5206\u6790\u7814\u7a76\u3002<\/span><\/span><\/p>\n

2.<\/span>\u7814\u7a76<\/span>API<\/span>\u7684\u6eb6\u89e3\u6027\u548c\u6eb6\u6db2\u7a33\u5b9a\u6027<\/span><\/strong><\/span><\/p>\n

\u5236\u5242\u6837\u54c1\u4e2d<\/span>API<\/span>\u7684\u6eb6\u89e3\u6027\u548c\u6eb6\u6db2\u7a33\u5b9a\u6027\u5f71\u54cd\u7740\u6700\u7ec8\u8d28\u91cf\u6807\u51c6\u7684\u5efa\u7acb\u3001\u8fc7\u7a0b\u4e2d\u5236\u5242\u6837\u54c1\u7ed3\u679c\u7684\u51c6\u786e\u6027\u3002<\/span><\/strong>\u90a3\u4e9b\u5bf9\u4e8e\u539f\u6599\u836f\u68c0\u6d4b\u4e2d\u7528\u5230\u7684\u6eb6\u89e3\u6eb6\u5242\uff0c\u5bf9\u4e8e\u5236\u5242\u800c\u8a00\u5219\u4e0d\u4e00\u5b9a\u9002\u7528\uff0c\u5982\u67d0<\/span>API<\/span>\u6709\u5173\u7269\u8d28\u6eb6\u5242\u4e3a\u7eaf\u4e59\u8148\uff0c\u4f46\u662f\u5236\u5242\u4e2d\u7531\u4e8e\u8f85\u6599\u7684\u5f71\u54cd\u4f7f\u7528\u7eaf\u4e59\u8148\u5f80\u5f80\u4f1a\u5bfc\u81f4<\/span>API<\/span>\u7684\u6eb6\u89e3\u5ea6\u964d\u4f4e\uff0c\u8fd9\u65f6\u53ef\u80fd\u9700\u8981\u8003\u8651\u5728\u6709\u673a\u76f8\u4e2d\u52a0\u5165\u5c11\u91cf\u6c34\u76f8\u6765\u589e\u52a0\u5236\u5242\u4e2d\u4e3b\u836f\u7684\u6eb6\u51fa\u548c\u6eb6\u89e3\uff0c\u4f46\u662f\u6eb6\u6db2\u7a33\u5b9a\u6027\u4ecd\u8981\u8fdb\u884c\u8003\u5bdf\u3002<\/span><\/span><\/p>\n

\u5f53<\/span>API<\/span>\u4e3a\u624b\u6027\u836f\u7269\u9700\u8981\u68c0\u6d4b\u5f02\u6784\u4f53\u65f6\uff0c\u5982\u679c\u5fc5\u987b\u91c7\u7528\u6b63\u76f8\u7cfb\u7edf\uff0c\u90a3\u4e48<\/span>API<\/span>\u5728\u5f02\u4e19\u9187\u3001\u65e0\u6c34\u4e59\u9187\u3001\u6b63\u5df1\u70f7\u7b49\u4e2d\u7684\u6eb6\u89e3\u5ea6\u4e5f\u662f\u9700\u8981\u91cd\u70b9\u8003\u5bdf\u7684\uff0c<\/span><\/strong>\u8fd9\u6709\u52a9\u4e8e\u5728\u65b9\u6cd5\u5f00\u53d1\u8fc7\u7a0b\u4e2d\u8bc4\u4f30\u6240\u91c7\u7528\u7684\u6eb6\u5242\u3001\u6837\u54c1\u5904\u7406\u65b9\u5f0f\u3002<\/span><\/span><\/p>\n

\u901a\u5e38\u540c\u4e00\u4efd\u6eb6\u5242\uff0c\u5355\u72ec<\/span>API<\/span>\u7684\u6eb6\u89e3\u5ea6\u4f1a\u6bd4<\/span>API+<\/span>\u8f85\u6599\u7684\u6eb6\u89e3\u5ea6\u5927\uff0c\u4f46\u8fd9\u4e5f\u4e0e<\/span>API<\/span>\u7684\u7ed3\u6784\u5f0f\u3001\u5904\u65b9\u4e2d\u8f85\u6599\u7684\u79cd\u7c7b\u548c\u91cf\u6709\u5173\uff0c\u6709\u4e9b\u8f85\u6599\u80fd\u591f\u6539\u53d8\u6700\u7ec8\u6eb6\u6db2\u7684<\/span>pH<\/span>\uff0c\u5f71\u54cd<\/span>API<\/span>\u7684\u6eb6\u89e3\u5ea6\u3002<\/span>\u5206\u6790\u4eba\u5458\u5e94\u8be5\u4e86\u89e3<\/span>API<\/span>\u7684\u7ed3\u6784\u5f0f\u4ee5\u53ca<\/span>pKa<\/span>\u3001\u6eb6\u89e3\u5ea6\u3001<\/span>pH<\/span>\u4f9d\u8d56\u6027\u7b49\u7279\u70b9\uff0c\u4e5f\u8981\u4e86\u89e3\u5904\u65b9\u4e2d\u6240\u7528\u7684\u8f85\u6599\u7684\u540d\u79f0\u3001\u6027\u8d28\u3001\u7528\u91cf\u60c5\u51b5\uff0c<\/span><\/strong>\u4e0d\u8981\u5728\u505a\u5236\u5242\u5206\u6790\u65f6\u8fde\u5904\u65b9\u7ec4\u6210\u8fd8\u4e0d\u6e05\u695a\u3002<\/span><\/span><\/p>\n

\u5206\u6790\u4eba\u5458\u6709\u65f6\u5728\u6837\u54c1\u914d\u5236\u8fc7\u7a0b\u4e2d\u53ef\u4ee5\u6d4b\u5b9a\u4e00\u4e0b\u6eb6\u6db2\u7684<\/span>pH<\/span>\uff0c\u8fd9\u53ef\u80fd\u6709\u52a9\u4e8e\u65b9\u6cd5\u7684\u5f00\u53d1\u4e0e\u5efa\u7acb\u3002<\/span><\/strong>\u5982\u67d0\u836f\u7269\u5728\u9178\u6027\u6761\u4ef6\u4e0b\uff08\u5982<\/span>pH<\/span>\u503c<\/span>1-2<\/span>\uff09\u6761\u4ef6\u4e0b\u7a33\u5b9a\uff0c\u800c\u5236\u5242\u6eb6\u6db2\u7531\u4e8e\u8f85\u6599\u7684\u539f\u56e0\u6eb6\u6db2\u53d1\u751f\u4e86<\/span>pH<\/span>\u6539\u53d8\uff0c\u90a3\u4e48\u5176\u7a33\u5b9a\u6027\u5c31\u53ef\u80fd\u4f1a\u53d7\u5230\u5f71\u54cd\uff0c\u5bfc\u81f4\u7ed3\u679c\u4e0d\u51c6\u786e\uff0c\u6240\u4ee5\u5e94\u8be5\u5bf9\u6eb6\u5242\u8fdb\u884c\u4f18\u5316\u7b5b\u9009\u8003\u5bdf\u3002<\/span><\/span><\/p>\n

\u6837\u54c1\u6eb6\u6db2\uff08\u5982\u542b\u91cf\u3001\u542b\u91cf\u5747\u5300\u5ea6\u3001\u6eb6\u51fa\u3001\u6709\u5173\u7269\u8d28\u7b49\uff09\u7684\u7a33\u5b9a\u6027\u5728\u68c0\u6d4b\u4e2d\u5f88\u91cd\u8981\uff0c\u5206\u6790\u4eba\u5458\u9700\u8981\u8bc4\u4f30\u6eb6\u6db2\u662f\u5426\u7a33\u5b9a\uff0c\u53ef\u4ee5\u91c7\u7528\u5f52\u4e00\u5316\u6cd5\uff0c\u8003\u5bdf\u5728\u5ba4\u6e29\u3001\u51b7\u85cf\u3001\u907f\u5149\u7b49\u6761\u4ef6\u4e0b\u7684\u7a33\u5b9a\u6027\u60c5\u51b5\uff0c\u5982\u679c\u4e0d\u7a33\u5b9a\uff0c\u5e94\u4e86\u89e3\u964d\u89e3\u901f\u5ea6\u5982\u4f55\uff1f\u6709\u54ea\u4e9b\u964d\u89e3\u4ea7\u7269\u51fa\u73b0\uff1f\u4e3b\u5cf0\u9762\u79ef\u53d8\u5316<\/span>%<\/span>\uff08\u901a\u5e38\u8ba4\u4e3a\u542b\u91cf\u3001\u6eb6\u51fa\u7b49\u4e3b\u5cf0\u9762\u79ef<\/span>RSD<\/span>\u5c0f\u4e8e<\/span>2.0%<\/span>\u53ef\u4ee5\u63a5\u53d7\uff09\uff1f\u54ea\u4e9b\u6761\u4ef6\u53ef\u4ee5\u51cf\u5c11\u6216\u907f\u514d\u964d\u89e3\uff1f\u9009\u62e9\u4f4e\u6e29\u4fdd\u5b58\u6837\u54c1\u3001\u5728\u77ed\u65f6\u95f4\u5185\u6d4b\u5b9a\u3001\u4f7f\u7528<\/span>UPLC<\/span>\u3001\u8fd8\u662f\u77ed\u8272\u8c31\u67f1\u53ef\u4ee5\u89e3\u51b3\u7a33\u5b9a\u6027\u95ee\u9898\u5417\uff1f<\/span><\/span><\/p>\n

3.<\/span>\u591a\u638c\u63e1\u4e00\u4e9b\u539f\u8f85\u6599\u76f8\u5bb9\u6027\u77e5\u8bc6<\/span><\/strong><\/span><\/p>\n

\u8f85\u6599\u672c\u8eab\u662f\u4e00\u79cd\u5177\u6709\u67d0\u79cd\u5b98\u80fd\u56e2\u7684\u5316\u5b66\u7269\u8d28\uff0c\u8fd9\u4e9b\u5b98\u80fd\u56e2\u5728\u5236\u5242\u7684\u6b63\u5e38\u8d2e\u85cf\u6761\u4ef6\u4e0b\u6216\u52a0\u901f\u6761\u4ef6\u4e0b\u53ef\u80fd\u4e0e<\/span>API<\/span>\u53d1\u751f\u76f8\u4e92\u4f5c\u7528\uff0c\u56e0\u6b64\u8f85\u6599\u4e0d\u80fd\u8ba4\u4e3a\u662f\u60f0\u6027\u7684\u3002<\/strong>\u8f85\u6599\u4e2d\u5e38\u89c1\u7684\u5f71\u54cd\u56e0\u7d20\u6709\u6c34\u5206\u3001<\/span>pH<\/span>\u503c\u7b49\uff0c\u5f53\u4e3b\u836f\u5bf9\u6e7f\u5ea6\u654f\u611f\u65f6\uff0c\u6c34\u5206\u9650\u5ea6\u5c31\u662f\u4e00\u4e2a\u5173\u952e\u7684\u56e0\u7d20\uff0c\u56e0\u6b64\u6709\u65f6\u9700\u8981\u63a7\u5236\u8f85\u6599\u4e2d\u6c34\u5206\u7684\u542b\u91cf\u3002\u8bb8\u591a\u836f\u7269\u7684\u6c34\u89e3\u53cd\u5e94\u6216\u6c27\u5316\u53cd\u5e94\u5747\u53d7<\/span>pH<\/span>\u503c\u7684\u5f71\u54cd\uff0c\u56e0\u6b64\u5f53\u53d1\u73b0\u8fd9\u79cd\u5f71\u54cd\u5b58\u5728\u65f6\uff0c\u4e0d\u540c\u5382\u5bb6\u6765\u6e90\u7684\u8f85\u6599\u6216\u4e0d\u540c\u578b\u53f7\u7684\u8f85\u6599\u5c31\u9700\u8981\u8003\u5bdf\u548c\u5236\u5b9a\u5185\u63a7\u6807\u51c6\u3002<\/strong>\u5e38\u89c1\u8f85\u6599\u5b98\u80fd\u56e2\u53ca\u5176\u529f\u80fd\u89c1\u8868<\/span>2<\/span>\u3002<\/span><\/span><\/p>\n

\u8868<\/span>2. <\/span>\u5e38\u89c1\u7684\u8f85\u6599\u57fa\u56e2\u53ca\u5176\u529f\u80fd<\/span><\/span><\/p>\n

\"\u3010\u5927\u5496\u8c08\u3011\u5236\u5242\u5f00\u53d1\u4e2d\uff0c\u5206\u6790\u4eba\u5458\u600e\u6837\u63d0\u5347\u81ea\u5df1\uff1f\"<\/p>\n

\u5982\u679c\u8f85\u6599\u4e0e\u4e3b\u836f\u76f8\u4e92\u4f5c\u7528\uff0c\u4ea7\u751f\u7684\u6742\u8d28\u5206\u5b50\u91cf\u53ef\u80fd\u6bd4\u4e3b\u836f\u5927\uff0c\u4e5f\u53ef\u80fd\u6bd4\u4e3b\u836f\u5c0f\uff0c\u8fd9\u610f\u5473\u7740\u5728<\/span>HPLC<\/span>\u4e2d\u53ef\u80fd\u6bd4\u4e3b\u836f\u5148\u51fa\u6765\uff0c\u4e5f\u53ef\u80fd\u540e\u51fa\u6765\uff0c\u79bb\u5b50\u578b\u7684\u6742\u8d28\u53ef\u80fd\u5c31\u5148\u6d17\u8131\u51fa\u6765\uff08\u6bd4\u5982\u6c28\u6c2f\u5730\u5e73\u7684\u52a0\u5408\u7269\u6742\u8d28\uff09\uff0c\u5bf9\u4e8e\u4e2d\u6027\u7684\u6742\u8d28\u53ef\u80fd\u540e\u6d17\u8131\u51fa\u6765\u3002<\/span><\/span><\/p>\n

<\/span>\u4e73\u7cd6\u548c\u76d0\u9178\u6c1f\u897f\u6c40\u4f1a\u53d1\u751f\u4f5c\u7528\uff0c\u8fd9\u662f\u4e00\u4e2a\u5178\u578b\u7684\u7f8e\u62c9\u5fb7\u53cd\u5e94\u3002<\/span><\/strong>\u53c2\u6bd4\u5236\u5242\u4e0e\u4e24\u4e2a\u4eff\u5236\u836f\u5728\u52a0\u901f\u6761\u4ef6<\/span>(40\u00b0C\/75% RH)<\/span>\u5bf9\u6bd4\u7814\u7a76\u8868\u660e\uff0c\u964d\u89e3\u6742\u8d28\u4e0d\u4e00\u81f4\uff0c\u7814\u7a76\u8868\u660e\u8fd9\u4e0e\u8f85\u6599\u7684\u7c7b\u578b\u548c\u5904\u65b9\u4e2d\u7684\u7528\u91cf\u6709\u5173<\/strong>\uff08\u89c1\u8868<\/span>3<\/span>\uff09\u3002<\/span><\/span><\/p>\n

\u8868<\/span>3. <\/span>\u76d0\u9178\u6c1f\u897f\u6c40\u5236\u5242\u5728\u52a0\u901f\u6761\u4ef6<\/span>(40\u00b0C\/75% RH)<\/span>\u7684\u7a33\u5b9a\u6027\u5bf9\u6bd4<\/span><\/span><\/p>\n

\"\u3010\u5927\u5496\u8c08\u3011\u5236\u5242\u5f00\u53d1\u4e2d\uff0c\u5206\u6790\u4eba\u5458\u600e\u6837\u63d0\u5347\u81ea\u5df1\uff1f\"<\/p>\n

\u539f\u8f85\u6599\u76f8\u5bb9\u6027\u8bd5\u9a8c\u5bf9\u5236\u5242\u6709\u5173\u7269\u8d28\u7b49\u68c0\u6d4b\u65b9\u6cd5\u9009\u62e9\u548c\u4f18\u5316\uff0c\u4ee5\u53ca\u8d28\u91cf\u6807\u51c6\u7684\u5efa\u7acb\u5177\u6709\u91cd\u8981\u63d0\u793a\u6216\u6307\u5bfc\u610f\u4e49\u3002<\/span><\/strong>
<\/span><\/span><\/p>\n

4.<\/span>\u591a\u4e86\u89e3\u4e00\u4e9b<\/span>HPLC<\/span>\u6cd5\u5728\u5236\u5242\u5206\u6790\u4e2d\u7684\u5e94\u7528<\/span><\/strong><\/span><\/p>\n

HPLC<\/span>\u6cd5\u662f\u5236\u5242\u5206\u6790\u4e2d\u6700\u5e38\u7528\u7684\u65b9\u6cd5\uff0c\u56e0\u6b64\u5e94\u8be5\u591a\u4e86\u89e3<\/span>HPLC<\/span>\u6cd5\u7684\u7279\u70b9\uff0c\u5982\u53cd\u76f8\u8272\u8c31\u3001\u6b63\u76f8\u8272\u8c31\u3001\u79bb\u5b50\u5bf9\u8272\u8c31\u6cd5\uff1b\u719f\u6089\u5e76\u6162\u6162\u79ef\u7d2f\u5404\u79cd\u68c0\u6d4b\u5668\u7684\u7c7b\u578b\u548c\u5e94\u7528\u7279\u70b9\uff0c\u5982<\/span>ELSD<\/span>\u3001<\/span>RID<\/span>\u3001<\/span>UV<\/span>\u3001<\/span>PDA<\/span>\u3001<\/span>FLD<\/span>\u3001<\/span>CAD<\/span>\u7b49\uff0c\u53ef\u4ee5\u7528\u4e8e\u6ca1\u6709<\/span>UV<\/span>\u5438\u6536\u3001\u6709<\/span>UV<\/span>\u5438\u6536\u3001\u5f31<\/span>UV<\/span>\u5438\u6536\u7b49\u7269\u8d28\u7684\u68c0\u6d4b\u3002\u4e0d\u540c\u7684\u8bd5\u9a8c\u76ee\u7684\u5173\u6ce8\u91cd\u70b9\u662f\u4e0d\u4e00\u6837\u7684\u3002<\/strong><\/span><\/span><\/p>\n

\u901a\u5e38<\/span>HPLC<\/span>\u6cd5\u6709\u5982\u4e0b\u5e94\u7528\uff1a<\/span><\/strong><\/span><\/p>\n

\uff08<\/span>1<\/span>\uff09\u6279\u68c0\u9a8c\u548c\u7a33\u5b9a\u6027\u8003\u5bdf\uff1a<\/span>\u9274\u522b\u3001\u6eb6\u51fa\u5ea6\u3001\u6709\u5173\u7269\u8d28\u3001\u5f02\u6784\u4f53\u3001\u542b\u91cf\u5747\u5300\u5ea6\u3001\u542b\u91cf\u6d4b\u5b9a<\/span><\/span><\/p>\n

\uff08<\/span>2<\/span>\uff09\u5de5\u827a\u9a8c\u8bc1\uff1a\u6df7\u5408\u5747\u5300\u5ea6\u3001\u6eb6\u51fa\u66f2\u7ebf<\/span>
<\/span><\/p>\n

\uff08<\/span>3<\/span>\uff09\u6e05\u6d01\u9a8c\u8bc1\uff1a\u9700\u8981\u7075\u654f\u5ea6\u8f83\u9ad8\u3001\u4e13\u5c5e\u6027\u597d\u7684<\/span>HPLC<\/span>\u6cd5<\/span>
<\/span><\/p>\n

\u5728\u6709\u5173\u7269\u8d28\u7814\u7a76\u4e2d\uff0c\u5236\u5242\u751f\u4ea7\u6216\u7a33\u5b9a\u6027\u4e2d\u4ea7\u751f\u7684\u6742\u8d28\u5e94\u8fdb\u884c\u7814\u7a76\u548c\u63a7\u5236\uff0c<\/span>HPLC<\/span>\u65b9\u6cd5\u5e94\u80fd\u591f\u5bf9\u6240\u6709\u5df2\u77e5\u6742\u8d28\u548c\u672a\u77e5\u6742\u8d28\u8fdb\u884c\u5206\u79bb\uff0c\u5177\u6709\u4e00\u5b9a\u7684\u4e13\u5c5e\u6027\uff08\u7a7a\u767d\u8f85\u6599\u4e0d\u5e72\u6270\u3001\u4e0e\u6709\u5173\u7269\u8d28\u5206\u79bb\u3001\u5cf0\u7eaf\u5ea6\u7b26\u5408\u8981\u6c42\uff09\u3001\u91cd\u590d\u6027\uff08\u7cbe\u5bc6\u5ea6\uff09\u3001\u5b9a\u91cf\uff08\u7ebf\u6027\u3001\u8303\u56f4\u3001<\/span>LOD<\/span>\u3001<\/span>LOQ<\/span>\u3001\u56de\u6536\u7387\uff09\uff0c\u8010\u7528\u6027\u8f83\u597d\u3002\u6709\u65f6\u539f\u6599\u836f\u6240\u4f7f\u7528\u7684\u6709\u5173\u7269\u8d28\u65b9\u6cd5\u9002\u7528\u4e8e\u5236\u5242\uff0c\u6709\u65f6\u4e0d\u9002\u7528\u3002\u5f53\u5de5\u827a\u6742\u8d28\u3001\u964d\u89e3\u6742\u8d28\u8f83\u591a\u65f6\u53ef\u4ee5\u8003\u8651\u5728\u539f\u6599\u836f\u7684\u65b9\u6cd5\u57fa\u7840\u4e0a\u8fdb\u884c\u4f18\u5316\uff0c\u91cd\u70b9\u8003\u5bdf\u8f85\u6599\u5e72\u6270\u60c5\u51b5\u3001\u6eb6\u5242\u9009\u62e9\u60c5\u51b5\u3002<\/strong><\/span><\/span><\/p>\n

5.<\/span>\u8ba4\u8bc6\u964d\u89e3\u8bd5\u9a8c\u7684\u4f5c\u7528<\/span><\/strong><\/span><\/p>\n

\u901a\u5e38\uff0c\u964d\u89e3\u8bd5\u9a8c\u5177\u6709\u5982\u4e0b\u4f5c\u7528\uff1a<\/span><\/p>\n

\uff08<\/span>1<\/span>\uff09\u65b9\u6cd5\u5f00\u53d1\u4e0e\u9a8c\u8bc1\u9636\u6bb5\u8003\u5bdf\u65b9\u6cd5\u7684\u4e13\u5c5e\u6027<\/span><\/span><\/p>\n

\uff08<\/span>2<\/span>\uff09\u5feb\u901f\u786e\u5b9a<\/span>API<\/span>\u548c\u5236\u5242\u7684\u964d\u89e3\u9014\u5f84\uff0c\u964d\u89e3\u6742\u8d28<\/span><\/span><\/p>\n

\uff08<\/span>3<\/span>\uff09\u8bc6\u522b\u54ea\u4e9b\u662f<\/span>API<\/span>\u7684\u964d\u89e3\u6742\u8d28\uff0c\u54ea\u4e9b\u662f<\/span>API<\/span>\u4e0e\u8f85\u6599\u76f8\u4e92\u5f71\u54cd\u624d\u4ea7\u751f\u7684\u964d\u89e3\u6742\u8d28<\/span><\/span><\/p>\n

\uff08<\/span>4<\/span>\uff09\u8003\u5bdf<\/span>API<\/span>\u7684\u7a33\u5b9a\u6027\u548c\u5bf9\u67d0\u79cd\u6761\u4ef6\u7684\u654f\u611f\u6027<\/span><\/span><\/p>\n

\uff08<\/span>5<\/span>\uff09\u8003\u5bdf<\/span>API<\/span>\u548c\u5236\u5242\u5728\u6db2\u4f53\u6216\u56fa\u4f53\u72b6\u6001\u4e0b\u7684\u7a33\u5b9a\u6027<\/span><\/span><\/p>\n

\uff08<\/span>6<\/span>\uff09\u7814\u7a76\u5728\u9ad8\u4e8e\u52a0\u901f\u6761\u4ef6\u4e0b<\/span>API<\/span>\u6216\u5236\u5242\u7684\u7a33\u5b9a\u6027\uff0c\u6307\u5bfc\u5305\u6750\u7684\u9009\u62e9\u548c\u8d2e\u85cf\u6761\u4ef6<\/span><\/span><\/p>\n

\uff08<\/span>7<\/span>\uff09\u7814\u7a76<\/span>API<\/span>\u6216\u5236\u5242\u5728\u70ed\u3001\u9178\u78b1\u6c34\u89e3\u3001\u6c27\u5316\u3001\u5149\u7167\u3001\u9ad8\u6e29\u9ad8\u6e7f\u7b49\u6761\u4ef6\u4e0b\u7684\u964d\u89e3\u673a\u7406<\/span><\/span><\/p>\n

\u5728\u505a\u964d\u89e3\u8bd5\u9a8c\u65f6\uff0c\u6bcf\u79cd\u836f\u7269\u7684\u964d\u89e3\u6761\u4ef6\u90fd\u662f\u4e0d\u4e00\u6837\u7684\uff0c\u6307\u5bfc\u539f\u5219\u81ea\u7136\u4e0d\u4f1a\u89c4\u5b9a\u5177\u4f53\u7684\u964d\u89e3\u6761\u4ef6\u3002\u5728\u5904\u65b9\u5de5\u827a\u5f00\u53d1\u8fc7\u7a0b\u4e2d\uff0c\u5206\u6790\u4eba\u5458\u5e94\u8be5\u7814\u7a76\u964d\u89e3\u6761\u4ef6\uff0c\u6700\u597d\u5e94\u591a\u6b21\u8fdb\u884c\u91cd\u590d\uff0c\u8003\u5bdf\u5176\u91cd\u73b0\u6027\uff08\u7279\u522b\u662f\u5f53\u91c7\u7528\u964d\u89e3\u6eb6\u6db2\u4f5c\u4e3a\u7cfb\u7edf\u9002\u7528\u6027\u6eb6\u6db2\u7684\u65f6\u5019\uff09\uff0c\u53ef\u4ee5\u91c7\u7528\u5236\u5242\u4e5f\u53ef\u4ee5\u91c7\u7528<\/span>API+<\/span>\u8f85\u6599\u7684\u5f62\u5f0f\u3002\u964d\u89e3\u7a0b\u5ea6\u4e00\u822c\u4e3a\u4e3b\u836f\u964d\u89e3<\/span>5%-10%<\/span>\uff0c\u4f46\u6709\u65f6\u5982\u679c\u53d1\u751f\u660e\u663e\u7684\u6b21\u7ea7\u964d\u89e3\u4e5f\u53ef\u9002\u5f53\u964d\u4f4e\u7a0b\u5ea6\u3002<\/span><\/span><\/p>\n

\u4e00\u822c\u964d\u89e3\u6761\u4ef6\u4e3a\uff1a<\/span><\/p>\n

\uff081\uff09\u70ed\uff1a\u5ba4\u6e29\u3001<\/span>40<\/span>\u2103\u3001<\/span>50<\/span>\u2103\u3001<\/span>60<\/span>\u2103<\/span><\/span><\/p>\n

\uff082\uff09\u5149\uff1a<\/span>ICH<\/span>\u6307\u5bfc\u539f\u5219<\/span><\/span><\/p>\n

\uff083\uff09\u6e7f\uff1a<\/span>75%RH<\/span><\/span><\/p>\n

\uff084\uff09\u9178\uff1a<\/span>0.1mol\/L<\/span>\u76d0\u9178<\/span><\/span><\/p>\n

\uff085\uff09\u78b1\uff1a<\/span>0.1mol\/L<\/span>\u6c22\u6c27\u5316\u94a0<\/span><\/span><\/p>\n

\uff086\uff09\u6c27\u5316\uff1a<\/span>3%<\/span>H2<\/sub>O2<\/sub><\/span>\u3001<\/span>AIBN<\/span>\u3001<\/span>BPO\u7b49<\/span><\/span><\/span><\/p>\n

\uff087\uff09\u6e7f\u70ed\uff1a<\/span>50<\/span>\u2103<\/span>+75%RH<\/span><\/span><\/p>\n

\u9700\u8981\u6ce8\u610f\u7684\u662f\uff0c\u5206\u6790\u4eba\u5458\u5e94\u6e05\u695a\u6bcf\u4e00\u9879\u964d\u89e3\u7684\u673a\u7406\u548c\u7a0b\u5ea6\uff0c\u4e0e\u5206\u6210\u4eba\u5458\u8fdb\u884c\u597d\u6c9f\u901a\uff0c\u4e0d\u5b9c\u964d\u89e3\u8fc7\u5ea6\uff0c\u5bfc\u81f4\u964d\u89e3\u8bd5\u9a8c\u5931\u771f\u3002<\/span><\/strong>\u6709\u4e9b\u964d\u89e3\u8bd5\u9a8c\u7ed3\u679c\u4e0d\u4e00\u5b9a\u80fd\u591f\u771f\u5b9e\u53cd\u6620\u51fa\u6765\uff0c\u9700\u8981\u4f53\u73b0\u51fa\u4e00\u5b9a\u7684\u76f8\u5173\u6027\u548c\u9884\u6d4b\u6027\u3002<\/span><\/span><\/p>\n


<\/p>\n

6.<\/span>\u5173\u6ce8\u6837\u54c1\u6eb6\u6db2\u7684\u5236\u5907\u65b9\u6cd5<\/span><\/strong><\/span><\/p>\n

\u6709\u4e9b\u5236\u5242\u5206\u6790\u4e2d\uff0c\u91c7\u7528\u5df2\u6709\u6807\u51c6\u4e2d\u7684\u4f9b\u8bd5\u54c1\u6eb6\u6db2\u5236\u5907\u65b9\u6cd5\uff0c\u4e0d\u4e00\u5b9a\u80fd\u591f\u5bf9\u4e3b\u836f\u8fdb\u884c\u5b8c\u5168\u63d0\u53d6\u3002\u5982\u679c\u7406\u8bba\u5206\u6790\u67d0\u603b\u6df7\u6837\u54c1\u4e2d\u4e3b\u836f\u542b\u91cf\u5e94\u4e3a<\/span>100%<\/span>\uff0c\u5b9e\u9645\u53ea\u6709<\/span>97%<\/span>\uff0c\u90a3\u4e48\u5e94\u8be5\u7ed3\u5408\u5de5\u827a\u635f\u5931\u3001\u53d6\u6837\u4ee3\u8868\u6027\u3001\u5206\u6790\u65b9\u6cd5\u6837\u54c1\u6eb6\u6db2\u5236\u5907\u8fc7\u7a0b\u7b49\u65b9\u9762\u8fdb\u884c\u7efc\u5408\u5206\u6790\u3002<\/strong><\/span><\/span><\/p>\n

\u4f8b\u5982\uff0c\u5728<\/span>Starlix \u00ae<\/span>\u548c\u76d0\u9178\u4e8c\u7532\u53cc\u80cd\u590d\u65b9\u5236\u5242\u4e2d\uff0c\u5728\u56de\u6536\u7387\u8bd5\u9a8c\u4e2d\uff0c\u53d1\u73b0\u4e8c\u7532\u53cc\u80cd\u7684\u56de\u6536\u7387\u5f88\u4f4e\uff0c\u8d77\u521d\u8ba4\u4e3a\u662f\u6eb6\u5242\u63d0\u53d6\u4e0d\u5b8c\u5168\uff0c\u56e0\u6b64\u91c7\u7528\u4e86\u4e0d\u540c\u6eb6\u5242\u8fdb\u884c\u8003\u5bdf\uff0c\u7ed3\u679c\u4ecd\u6ca1\u6709\u6539\u5584\uff08\u89c1\u8868<\/span>4<\/span>\uff09\u3002\u96be\u9053\u662f\u4e8c\u7532\u53cc\u80cd\u4e0e\u67d0\u4e2a\u8f85\u6599\u5728\u6eb6\u6db2\u4e2d\u53d1\u751f\u4e86\u76f8\u4e92\u4f5c\u7528\uff1f\u8fd9\u65f6\u5e94\u8be5\u600e\u4e48\u7814\u7a76\u5462\uff1f\u5206\u6790\u4eba\u5458\u91c7\u7528\u4e8c\u7532\u53cc\u80cd\u4e0e\u6240\u6709\u8f85\u6599\u8fdb\u884c\u5e72\u6df7\u5408\uff0c\u7136\u540e\u9010\u4e00\u53bb\u6389\u4e00\u4e2a\u8f85\u6599\uff0c\u914d\u5236\u6210\u6eb6\u6db2\uff0c\u7ed3\u679c\u8868\u660e\u5f53\u53bb\u6389\u4ea4\u8054\u7fa7\u7532\u57fa\u7ea4\u7ef4\u7d20\u540e\uff0c\u4e8c\u7532\u53cc\u80cd\u7684\u56de\u6536\u7387\u5408\u683c\u4e86\uff0c\u8fbe<\/span>99.7%<\/span>\uff08\u89c1\u56fe<\/span>4<\/span>\uff09\uff0c\u8fd9\u8bf4\u660e\u4e8c\u7532\u53cc\u80cd\u4e0e\u4ea4\u8054\u7fa7\u7532\u57fa\u7ea4\u7ef4\u7d20\u53ef\u80fd\u5728\u6eb6\u6db2\u4e2d\u53d1\u751f\u4e86\u53cd\u5e94<\/strong>\uff0c\u673a\u7406\u89c1\u56fe<\/span>5<\/span>\u3002<\/span><\/span><\/p>\n

\u8868<\/span>4. <\/span>\u4e0d\u540c\u6eb6\u5242\u4e0b\u4e8c\u7532\u53cc\u80cd\u7684\u63d0\u53d6\u56de\u6536\u7387<\/span><\/span><\/p>\n

\"\u3010\u5927\u5496\u8c08\u3011\u5236\u5242\u5f00\u53d1\u4e2d\uff0c\u5206\u6790\u4eba\u5458\u600e\u6837\u63d0\u5347\u81ea\u5df1\uff1f\"<\/p>\n

\"\u3010\u5927\u5496\u8c08\u3011\u5236\u5242\u5f00\u53d1\u4e2d\uff0c\u5206\u6790\u4eba\u5458\u600e\u6837\u63d0\u5347\u81ea\u5df1\uff1f\"
<\/p>\n

\u56fe<\/span>4. <\/span>\u4e0d\u540c\u8f85\u6599\u7ec4\u6210\u4e0b\u4e8c\u7532\u53cc\u80cd\u7684\u63d0\u53d6\u56de\u6536\u7387<\/span><\/span><\/p>\n


<\/p>\n

\u56fe<\/span>5. <\/span>\u4e8c\u7532\u53cc\u80cd\u4e0e\u4ea4\u8054\u7fa7\u7532\u57fa\u7ea4\u7ef4\u7d20\u5b98\u80fd\u56e2\u7684\u76f8\u4e92\u4f5c\u7528<\/span>
<\/span><\/p>\n

\u8fd9\u4e2a\u4f8b\u5b50\u8bf4\u660e\uff0c<\/span>\u8f85\u6599\u5728\u56fa\u4f53\u65f6\u4e0e<\/span>API<\/span>\u6ca1\u6709\u76f8\u4e92\u4f5c\u7528\uff0c\u4f46\u662f\u5728\u6eb6\u6db2\u4e2d\u5374\u53d1\u751f\u4e86\u4f5c\u7528\u3002<\/span><\/strong>\u6240\u4ee5\u5728\u5236\u5242\u914d\u5236\u6210\u6eb6\u6db2\u6216\u8bbe\u8ba1\u5904\u65b9\u65f6\u5e94\u8003\u8651\u591a\u79cd\u56e0\u7d20\uff0c\u5982\u6240\u9009\u6eb6\u5242\u7684\u7ec4\u6210\uff0c\u662f\u7eaf\u6709\u673a\u76f8\u8fd8\u662f\u7eaf\u6c34\u76f8\uff0c\u6216\u4e8c\u8005\u7684\u6bd4\u4f8b\u5982\u4f55\uff1b\u6b63\u76f8\u5206\u6790\u65f6\u4e00\u822c\u4e3a\u975e\u6781\u6027\u548c\u6781\u6027\u6eb6\u5242\u7684\u6df7\u5408\u7269\u3002\u63d0\u53d6\u56de\u6536\u7387\u4e0e\u6eb6\u5242\uff08\u79cd\u7c7b\u3001\u91cf\uff09\u3001\u63d0\u53d6\u6761\u4ef6\uff08\u65f6\u95f4\uff09\u3001\u8f85\u6599\u7ec4\u6210\u3001\u6eb6\u6db2\u4e2d\u7684\u4e3b\u836f\u548c\u8f85\u6599\u7684\u7406\u5316\u6027\u8d28\u6709\u5173\u3002<\/strong><\/span><\/span><\/p>\n

\u4e00\u4e2a\u597d\u7684\u5206\u6790\u4eba\u5458\u9047\u5230\u95ee\u9898\u65f6\u5e94\u8be5\u80fd\u591f\u5bf9\u8fd9\u4e9b\u95ee\u9898\u8fdb\u884c\u89e3\u91ca\uff0c\u8fc7\u7a0b\u4e2d\u8981\u4e0d\u65ad\u4e0e\u5408\u6210\u4eba\u5458\u3001\u5236\u5242\u4eba\u5458\u6c9f\u901a\u3002<\/span><\/p>\n

7.<\/span>\u5728\u5177\u4f53\u5de5\u4f5c\u4e2d\u63d0\u5347\u80fd\u529b<\/span><\/strong><\/span><\/p>\n

\u5728\u836f\u7269\u7814\u53d1\u6574\u4e2a\u94fe\u6761\u4e2d\uff0c\u4e0e\u5206\u6790\u6253\u4ea4\u9053\u8f83\u591a\u7684\u662f\u5408\u6210\u3001\u5236\u5242\uff0c\u968f\u7740\u6211\u56fd\u7814\u53d1\u601d\u8def\u548c\u7406\u5ff5\u7684\u53d8\u5316\uff0c\u5df2\u7ecf\u65e9\u5df2\u4e0d\u5b58\u5728\u54ea\u4e2a\u66f4\u91cd\u8981\u7684\u95ee\u9898\u4e86\uff0c\u836f\u54c1\u4ece\u7acb\u9879\u5230\u4e0a\u5e02\u6574\u4e2a\u8fc7\u7a0b\u4e2d\u4efb\u4f55\u4e00\u73af\u90fd\u540c\u6837\u91cd\u8981\uff0c\u6ca1\u6709\u4e3b\u6b21\u3002<\/strong><\/span><\/p>\n

\u5728\u5236\u5242\u5206\u6790\u4e2d\uff0c\u7814\u53d1\u5206\u6790\u4eba\u5458\u4e0e<\/span>QC<\/span>\u4eba\u5458\u6709\u5f88\u5927\u7684\u533a\u522b\uff0c\u9700\u8981\u7814\u53d1\u5206\u6790\u4eba\u5458\u5728\u8bbe\u8ba1\u65b9\u6cd5\u3001\u65b9\u6848\u65f6\u591a\u8003\u8651\u79d1\u5b66\u6027\u3001\u5408\u89c4\u6027\u3001\u903b\u8f91\u6027\uff1b\u540c\u65f6\u8fd8\u8981\u517c\u987e\u5404\u79cd\u6548\u7387\uff0c\u6bd4\u5982\u6eb6\u51fa\u66f2\u7ebf\u68c0\u6d4b\u65f6\u5927\u91cf\u6837\u54c1\u5982\u4f55\u9ad8\u6548\u68c0\u6d4b\uff1f\u51c6\u786e\u68c0\u6d4b\uff1f\u91c7\u7528<\/span>UV<\/span>\u6cd5\uff1f<\/span>UPLC<\/span>\u6cd5\uff1f<\/span>HPLC<\/span>\u77ed\u67f1\uff1f\u7a00\u91ca\u540e\u8fdb\u6837\uff1f\u76f4\u63a5\u8fdb\u6837\uff1f\u8fd9\u4e9b\u90fd\u8981\u8fdb\u884c\u5168\u9762\u8003\u91cf\u3002\u4ece\u4e8b\u5236\u5242\u5206\u6790\uff0c\u4e5f\u8981\u61c2\u5236\u5242\uff0c\u61c2\u67d0\u4e2a\u54c1\u79cd\u5904\u65b9\u5de5\u827a\u8bbe\u8ba1\u7684\u601d\u8def\u548c\u5173\u952e\u70b9\u3001\u63a7\u5236\u70b9\u3002\u5728\u5177\u4f53\u5b9e\u8df5\u4e2d\u591a\u601d\u8003\u3001\u591a\u603b\u7ed3\uff0c\u4e0d\u8981\u5c40\u9650\u4e8e\u5206\u6790\u672c\u8eab\uff0c\u5728\u5b9e\u8df5\u4e2d\u8fdb\u6b65\u624d\u662f\u5206\u6790\u4eba\u5458\u63d0\u5347\u81ea\u5df1\u7684\u65b9\u5411\u3002<\/strong><\/span><\/span><\/p>\n

\u7814\u53d1\u5206\u6790\u4eba\u5458\u8981\u719f\u6089\u6cd5\u89c4\uff0c\u4e0d\u4ec5\u4ec5\u662f\u8d28\u91cf\u7814\u7a76\u65b9\u9762\u7684\uff0c\u5728\u5408\u6210\u3001\u5236\u5242\u3001\u6ce8\u518c\u3001\u533b\u5b66\u3001\u4e13\u5229\u3001<\/span>GMP<\/span>\u3001<\/span>QC<\/span>\u3001<\/span>QA<\/span>\u7b49\u5404\u4e2a\u65b9\u9762\u90fd\u8981\u719f\u6089\u624d\u884c\u3002\u5206\u6790\u662f\u4e00\u4e2a\u5168\u9762\u7684\u5de5\u4f5c\uff0c\u9700\u8981\u5728\u8fc7\u7a0b\u4e2d\u4e92\u76f8\u7406\u89e3\u3001\u5305\u5bb9\u3001\u6c9f\u901a\uff0c\u6c9f\u901a\u53ef\u4ee5\u89e3\u51b3\u4e00\u5207\u95ee\u9898\uff01<\/strong><\/span>\u5206\u6790\u4e0d\u4ec5\u4ec5\u662f\u4e00\u4efd\u5de5\u4f5c\uff0c\u66f4\u662f\u4e00\u4efd\u8d23\u4efb\uff0c\u56e0\u4e3a\u4f01\u4e1a\u91cc\u6240\u6709\u73af\u8282\u7684\u4eba\u90fd\u9762\u5bf9\u540c\u4e00\u4e2a\u5ba2\u6237<\/span>\u2014\u2014CFDA<\/span>\uff01<\/span><\/strong><\/span><\/p>\n

\u5236\u5242\u5206\u6790\u4eba\u5458\u5728\u5b9e\u9645\u5de5\u4f5c\u4e2d\u4f1a\u79ef\u7d2f\u8d77\u5927\u91cf\u7684\u6570\u636e\uff0c\u8fd9\u4e9b\u6570\u636e\u5982\u4f55\u53d1\u6325\u66f4\u5927\u7684\u4f5c\u7528\uff1f\u4f5c\u8005\u60f3\u7528\u4e24\u4e2a\u5b57\u8fdb\u884c\u6982\u62ec<\/span>\u2014\u2014 <\/span>\u201c<\/span>\u63a7\u5236<\/span>\u201d<\/span>\uff0c\u5ef6\u4f38\u8bb2\u5c31\u662f\u6e90\u5934\u63a7\u5236\u3001\u8fc7\u7a0b\u63a7\u5236\u3001\u91cd\u70b9\u63a7\u5236\u3001\u5168\u9762\u63a7\u5236\u3002<\/span><\/strong>\u8981\u6ce8\u610f\u6570\u636e\u95f4\u7684\u5173\u7cfb\uff0c\u6570\u636e\u4f53\u73b0\u51fa\u6765\u7684\u903b\u8f91\u5173\u7cfb\u3001\u5236\u5242\u5904\u65b9\u5de5\u827a\u4e2d\u66b4\u9732\u51fa\u7684\u95ee\u9898\uff0c\u662f\u7269\u6599\u3001\u4e2d\u95f4\u4f53\u7684\u5c5e\u6027\u95ee\u9898\uff0c\u8fd8\u662f\u5de5\u827a\u95ee\u9898\uff1f\u5982\u4f55\u4fdd\u8bc1\u6279\u95f4\u7684\u5747\u7a33\u5065\u6027\uff0c\u91cd\u73b0\u6027\uff1f\u5f80\u5f80\u9700\u8981\u575a\u6301<\/span>\u201c<\/span>\u63a7\u5236<\/span>\u201d<\/span>\u7684\u7406\u5ff5\u3002<\/span><\/span><\/p>\n

\u5206\u6790\u4eba\u5458\u4e0d\u4ec5\u4ec5\u662f\u68c0\u6d4b\u6837\u54c1\u3001\u8d28\u91cf\u7814\u7a76\u3001\u7a33\u5b9a\u6027\u8003\u5bdf\u3001\u5efa\u7acb\u6807\u51c6\u3001\u5f00\u53d1\u65b9\u6cd5\u3001\u65b9\u6cd5\u5b66\u9a8c\u8bc1\uff0c\u66f4\u91cd\u8981\u7684\u662f\u65b9\u6cd5\u3001\u6570\u636e\u3001\u95ee\u9898\u7b49\u80cc\u540e\u7684\u4e3a\u4ec0\u4e48\uff0c\u8981\u77e5\u5176\u7136\uff0c\u77e5\u5176\u6240\u4ee5\u7136\u3002<\/strong><\/span><\/p>\n

\u603b\u4e4b\uff0c\u5236\u5242\u5f00\u53d1\u4e2d\uff0c\u5206\u6790\u4eba\u5458\u5e94\u6ce8\u610f\u7684\u4e8b\u60c5\u8fdc\u8fdc\u4e0d\u6b62\u4e0a\u8ff0\u5185\u5bb9\uff0c\u5206\u6790\u4eba\u5458\u8981\u591a\u603b\u7ed3\u3001\u591a\u601d\u8003\u3001\u591a\u6c9f\u901a\u3001\u591a\u5305\u5bb9\uff0c\u4e3a\u9879\u76ee\u505a\u5230\u8d1f\u8d23\uff01<\/strong><\/span><\/p>\n

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


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