{"id":98174,"date":"2019-03-06T00:00:50","date_gmt":"2019-05-17T08:13:24","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/98174\/"},"modified":"2019-05-17T16:13:27","modified_gmt":"2019-05-17T08:13:27","slug":"f3dc482553","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/98174\/","title":{"rendered":"CDE\u6587\u7ae0|\u57fa\u4e8e\u751f\u7269\u836f\u5242\u5b66\u7cfb\u7edf\u5206\u7c7b\u7684\u751f\u7269\u8c41\u514d\u7684\u51e0\u70b9\u8003\u8651"},"content":{"rendered":"
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Some considerations about biowaiver based biopharmaceutics classification system<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u6765\u6e90<\/strong><\/p>\n<\/section>\n

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\u4f5c\u8005<\/strong><\/p>\n<\/section>\n

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\u6458\u8981<\/strong><\/p>\n<\/section>\n

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\u57fa\u4e8e\u751f\u7269\u836f\u5242\u5b66\u7cfb\u7edf\u5206\u7c7b( BCS) \u7684\u751f\u7269\u8c41\u514d\u5df2\u5728\u56fd\u9645\u76d1\u7ba1\u673a\u6784\u5e7f\u4e3a\u4f7f\u7528\u3002<\/p>\n

\u6211\u56fd\u4e5f\u57282016 \u5e74\u53d1\u5e03\u4e86\u9488\u5bf9\u4eff\u5236\u836f\u4e00\u81f4\u6027\u8bc4\u4ef7\u7684\u300a\u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027\u8c41\u514d\u6307\u5bfc\u539f\u5219\u300b\uff0c\u5e76\u57282018 \u5e745 \u6708\u63a8\u51fa\u4e86\u300a\u53ef\u8c41\u514d\u6216\u7b80\u5316\u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c( BE) \u54c1\u79cd\u540d<\/span>\u5355\u300b\uff0c\u63d0\u51fa\u4e86\u90e8\u5206\u53ef\u6309\u7167BCS1 \u7c7b\u62163 \u7c7b\u8c41\u514d\u7684\u54c1\u79cd\u3002\u672c\u6587\u6839\u636e\u5404\u56fd\u751f\u7269\u8c41\u514d\u7684<\/span>\u6307\u5357\u8981\u6c42\uff0c\u5206\u6790\u4e86\u5728\u56fd\u5185\u7533\u8bf7BCS \u8c41\u514d\u5e94\u8003\u8651\u7684\u95ee\u9898\uff0c\u4e3a\u4f01\u4e1a\u63d0\u4f9b\u53c2\u8003\uff0c\u51cf\u5c11\u4e0d<\/span>\u5fc5\u8981\u7684BE \u7814\u7a76\u548c\u52a0\u901f\u9ad8\u8d28\u91cf\u836f\u54c1\u7684\u7814\u53d1\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u6b63 \u6587<\/strong><\/p>\n<\/section>\n

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\u76ee\u524d\uff0c\u4f53\u5185\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c( BE) \u662f\u8bc1\u660e\u53d7\u8bd5\u836f\u4e0e\u53c2\u6bd4\u836f\u6cbb\u7597\u7b49\u6548\u7684\u6700\u5e38\u7528\u65b9\u6cd5\u3002\u4f46\u5bf9\u4e8e\u4e00\u4e9b\u5438\u6536\u826f\u597d\u7684\u836f\u7269\uff0c\u836f\u7269\u6eb6\u51fa\u6216\u80c3\u6392\u7a7a( \u6eb6\u51fa\u901f\u7387\u975e\u5e38\u5feb\u65f6) \u662f\u8fd9\u7c7b\u836f\u7269\u7684\u9650\u901f\u6b65\u9aa4\u3002\u6eb6\u51fa\u975e\u5e38\u8fc5\u901f\u65f6\uff0c\u80c3<\/span>\u6392\u7a7a\u662f\u836f\u7269\u5438\u6536\u7684\u9650\u901f\u6b65\u9aa4\uff0c\u4f46\u6eb6\u51fa\u901f\u7387\u4e0e\u836f\u7269\u5438\u6536\u901f\u7387\u6ca1\u6709\u76f8\u5173<\/span>\u6027\u3002<\/span><\/p>\n

\u6b64\u65f6\uff0c\u4f53\u5185\u8840\u836f\u6d53\u5ea6\uff0d \u65f6\u95f4\u66f2\u7ebf\u5e76\u4e0d\u80fd\u53cd\u6620\u5236\u5242\u4e4b\u95f4\u7684\u5dee\u5f02\uff0c\u800c<\/span>\u662f\u53cd\u6620\u4e86\u53d7\u8bd5\u8005\u80c3\u6392\u7a7a\u7684\u5dee\u5f02\u3002\u8fd9\u7c7b\u836f\u7269\u8fdb\u884c\u4f53\u5185\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u7684\u5fc5\u8981\u6027\u8f83\u5c0f\uff0c\u5728\u4fdd\u8bc1\u53d7\u8bd5\u836f\u4e0e\u53c2\u6bd4\u836f\u4f53\u5916\u6eb6\u51fa\u4e00\u81f4\u7684\u60c5\u51b5\u4e0b\uff0c\u836f\u7269<\/span>\u7684\u5438\u6536\u901f\u5ea6\u548c\u7a0b\u5ea6\u4ec5\u53d6\u51b3\u4e8e\u6d3b\u6027\u836f\u7269\u6210\u5206( API) \u7684\u7279\u6027\uff3b1 \uff0d 3\uff3d\u3002<\/span><\/p>\n

\u56fd\u9645<\/span>\u4e0a\u5305\u62ec\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40( FDA) \uff3b4\uff3d\u3001\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40<\/span>( EMA) \uff3b5\uff3d\u3001\u4e16\u754c\u536b\u751f\u7ec4\u7ec7( WHO) \uff3b6\uff3d\u7b49\u76d1\u7ba1\u673a\u6784\u5206\u522b\u51fa\u53f0\u4e86\u57fa\u4e8e\u751f\u7269<\/span>\u836f\u5242\u5b66\u7cfb\u7edf\u5206\u7c7b( BCS) \u8c41\u514d\u7684\u6307\u5bfc\u539f\u5219\u3002<\/span><\/p>\n

\u6211\u56fd\u4e5f\u4e8e2016 \u5e74\u53d1\u5e03\u4e86<\/span>\u300a\u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u8c41\u514d\u6307\u5bfc\u539f\u5219\u300b( \u4ee5\u4e0b\u7b80\u79f0\u8c41\u514d\u6307\u5bfc\u539f\u5219) \uff3b7\uff3d\u3002<\/span><\/p>\n

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

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\u8fd9\u8868\u660e\u5e38\u91ca\u5236\u5242\u572815 min \u5185\u6eb6\u51fa85% \u53ef\u80fd\u80fd<\/span>\u591f\u4fdd\u8bc1\u4e24\u8005\u751f\u7269\u7b49\u6548\u3002<\/span><\/p>\n

\u56e0\u6b64\uff0c\u5bf9\u4e8e\u5feb\u901f\u6eb6\u51fa\u836f\u7269\uff0c\u5728<\/span>\u4fdd\u8bc1\u6eb6\u51fa\u66f2\u7ebf\u4e00\u81f4\u7684\u524d\u63d0\u4e0b\uff0c\u836f\u7269\u5438\u6536\u7684\u901f\u5ea6\u548c\u7a0b\u5ea6<\/span>\u53d6\u51b3\u4e8e\u80c3\u6392\u7a7a\u901f\u7387\u800c\u975e\u5236\u5242\u56e0\u7d20\u3002<\/span><\/p>\n

BCS3 \u7c7b\u9ad8\u6eb6\u89e3\u6027\uff0d \u4f4e\u6e17\u900f\u6027\u836f\u7269\u6e17\u900f\u6027\u662f\u8fd9\u7c7b\u836f\u7269\u5438\u6536\u7684\u9650\u901f\u6b65\u9aa4\u3002<\/span><\/p>\n

\u9664\u4e86\u5efa\u7acb\u826f\u597d\u7684\u6eb6\u51fa\u66f2\u7ebf<\/span>\u5916\uff0cBCS1 \u7c7b\u7684\u6eb6\u51fa\u60c5\u51b5\u4e5f\u9002\u7528\u4e8e\u80c3\u6392\u7a7a\u901f\u7387\u4e3a\u9650\u901f<\/span>\u6b65\u9aa4\u7684\u5e38\u91ca\u5236\u5242\u3002\u836f\u7269\u7684\u5438\u6536\u901f\u7387\u548c\u5438\u6536\u7a0b\u5ea6\u5728\u8fd9<\/span>\u7c7b\u836f\u7269\u4e2d\u53d8\u5f02\u6027\u8f83\u5927\uff0c\u4f46\u5982\u679c\u836f\u7269\u6eb6\u51fa\u5341\u5206\u8fc5\u901f\uff0c\u4f8b\u5982\u572815 min \u5185\u6eb6\u51fa85%\uff0c\u90a3\u4e48\u53d8\u5f02\u6027\u7684\u6765\u6e90\u4fbf\u662f\u80c3<\/span>\u80a0\u8f6c\u8fd0\u3001\u80a0\u5185\u5bb9\u7269\u4ee5\u53ca\u819c\u6e17\u900f\u6027\uff0c\u800c\u975e\u836f\u7269\u5236\u5242\u56e0\u7d20\u3002<\/span><\/p>\n

\u56e0\u6b64\u5728\u4fdd\u8bc1\u6eb6\u51fa\u66f2\u7ebf\u4e00\u81f4\u7684\u524d\u63d0\u4e0b\uff0c\u8fd9\u7c7b\u836f\u7269\u7684\u5438\u6536<\/span>\u901f\u5ea6\u548c\u7a0b\u5ea6\u53d6\u51b3\u4e8e\u4e0e\u80c3\u80a0\u8f6c\u8fd0\u3001\u80a0\u5185\u5bb9\u7269\u3001\u819c\u6e17\u900f\u6027<\/span>\u76f8\u5173\u7684API \u7279\u6027\u548c\u8f85\u6599\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n
\n
\n
\n

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

\n
\n

\u751f\u7269\u8c41\u514d\u5e94\u6ce8\u610f\u7684\u95ee\u9898<\/strong><\/p>\n<\/section>\n<\/section>\n

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

\u6839\u636e\u6211\u56fd\u300a\u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u8c41\u514d\u6307\u5bfc\u539f\u5219\u300b\uff0cBCS1 \u7c7b\u548cBCS3 \u7c7b\u7684\u836f\u54c1\u9700\u6ee1\u8db3\u4e0d\u540c\u7684\u6761\u4ef6\uff0c\u89c1\u88682\u3002<\/span><\/p>\n

\"CDE\u6587\u7ae0|\u57fa\u4e8e\u751f\u7269\u836f\u5242\u5b66\u7cfb\u7edf\u5206\u7c7b\u7684\u751f\u7269\u8c41\u514d\u7684\u51e0\u70b9\u8003\u8651\"<\/p>\n

\u4e0d\u96be\u770b\u51fa\uff0cBCS3 \u7c7b\u836f\u7269\u751f\u7269\u8c41\u514d\u7684\u96be\u70b9\u5728\u4e8e\u5904<\/span>\u65b9Q1 \u4e0eQ2 \u4e00\u81f4; BCS1 \u7c7b\u836f\u7269\u751f\u7269\u8c41\u514d\u7684\u96be\u70b9\u5728\u4e8e<\/span>\u8bc1\u660e\u5176\u9ad8\u6e17\u900f\u6027\u3002<\/span><\/p>\n

\u6709\u522b\u4e8e\u6eb6\u89e3\u6027\u548c\u6eb6\u51fa\u6570\u636e\u7684\u7b80\u5355<\/span>\u6613\u83b7\u53d6\uff0c\u6e17\u900f\u6027\u6570\u636e\u7684\u63d0\u4f9b\u5e76\u4e0d\u5bb9\u6613\uff0c\u6709\u4e9b\u6e17\u900f\u6027\u8bd5<\/span>\u9a8c\u7684\u6210\u672c\u751a\u81f3\u8d85\u8fc7\u4e86\u4f53\u5185\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u7684\u6210\u672c\u3002<\/span><\/p>\n

\u4e0b\u6587\u4ece\u6eb6\u89e3\u5ea6\u3001\u6e17\u900f\u6027\u3001\u6eb6\u51fa\u548c\u8f85\u65994 \u4e2a\u65b9\u9762\u9610\u8ff0<\/span>BCS \u8c41\u514d\u5e94\u6ce8\u610f\u7684\u95ee\u9898\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

2. 1 \u6eb6\u89e3\u6027<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

\u6eb6\u89e3\u6027\u4e00\u822c\u8981\u6c42\u91c7\u7528\u539f\u6599\u836f\u8fdb\u884c\u7814\u7a76\u3002\u6587\u732e\u6570\u636e\u5f80\u5f80\u7531\u4e8e\u6570\u636e\u4e0d\u5145\u5206\u800c\u96be\u4ee5\u8bc4\u4ef7\u3002<\/span><\/p>\n

\u6eb6\u89e3\u5ea6\u5e94\u5728<\/span>( 37 \u00b11) \u2103\u3001pH \u503c1. 0 \uff5e 6. 8 \u5185\u7684\u6c34\u4ecb\u8d28\u4e2d\u6d4b\u5b9a\u3002\u901a\u5e38<\/span>\u5305\u62ecpH = pKa\uff0cpH = pKa + 1\uff0cpH = pKa \uff0d 1\uff0c\u4ee5\u53capH =<\/span>1. 0 \u548c6. 8 \u8fd9\u51e0\u4e2a\u6761\u4ef6\u3002<\/span><\/p>\n

\u82e5pKa \u4e0d\u5728pH \u503c1. 0 \uff5e 6. 8<\/span>\u5185\uff0c\u4e5f\u5e94\u9009\u62e9\u5145\u8db3\u7684pH \u70b9\u8bc4\u4ef7pH \uff0d \u6eb6\u89e3\u5ea6\u66f2\u7ebf\u3002<\/span>\u6d4b\u5b9a\u6eb6\u89e3\u5ea6\u65f6\u6bcf\u4e2apH \u6761\u4ef6\u81f3\u5c11\u8981\u8fdb\u884c3 \u6b21\u5e73\u884c<\/span>\u6d4b\u5b9a\u3002<\/span><\/p>\n

\u539f\u6599\u836f\u52a0\u5165\u7f13\u51b2\u6db2\u4e4b\u540e\uff0c\u7f13\u51b2\u6db2\u7684pH \u503c\u9700\u8981<\/span>\u518d\u6b21\u6d4b\u5b9a\u3002<\/span><\/p>\n

\u4e0a\u8ff0\u65b9\u6cd5\u6d4b\u5f97\u7684\u6eb6\u89e3\u5ea6\u6700\u4f4e\u503c\u53ef\u7528\u4e8e\u5224<\/span>\u5b9a\u836f\u7269\u5206\u7c7b\u3002<\/span><\/p>\n

\u836f\u7269\u5728\u7f13\u51b2\u4ecb\u8d28\u4e2d\u6eb6\u89e3\u540e\uff0c\u5e94\u4f7f\u7528\u7ecf\u8fc7<\/span>\u9a8c\u8bc1\u7684\u542b\u91cf\u6d4b\u5b9a\u65b9\u6cd5\u6d4b\u5b9aAPI \u7684\u6d53\u5ea6\uff0c\u800c\u975e\u76ee\u6d4b\u5224\u65ad<\/span>\u5176\u662f\u5426\u6eb6\u89e3\u3002<\/span><\/p>\n

\u82e5\u89c2\u5bdf\u5230\u539f\u6599\u836f\u7684\u964d\u89e3\u662f\u7f13\u51b2\u6db2\u6210\u5206<\/span>\u6216\u8005pH \u503c\u9020\u6210\u7684\uff0c\u5219\u4e5f\u5e94\u8be5\u63d0\u4ea4\u80c3\u80a0\u9053\u7a33\u5b9a\u6027\u7814\u7a76<\/span>\u90e8\u5206\u7684\u7a33\u5b9a\u6027\u6570\u636e\u3002<\/span><\/p>\n

\u6839\u636e\u6d4b\u91cf\u5728pH \u503c1. 0 \uff5e 6. 8 \u5185<\/span>\u6c34\u6eb6\u6027\u7f13\u51b2\u4ecb\u8d28\u4e2d\u836f\u7269\u6eb6\u89e3\u7684\u6700\u9ad8\u5242\u91cf\u6765\u786e\u5b9a\u836f\u7269<\/span>\u7684\u6eb6\u89e3\u5ea6\u7c7b\u522b\u3002<\/span><\/p>\n

\u5f53\u67d0\u79cd\u836f\u7269\u7684\u6700\u5927\u5242\u91cf\u80fd\u5728pH \u503c<\/span>1. 0 \uff5e 6. 8 \u5185\u3001\u5b8c\u5168\u6eb6\u89e3\u5728\u5c0f\u4e8e250 mL \u7684\u6c34\u6eb6\u6027\u7f13\u51b2<\/span>\u4ecb\u8d28\u4e2d\uff0c\u53ef\u8ba4\u4e3a\u8be5\u836f\u7269\u662f\u9ad8\u6eb6\u89e3\u6027\u7684\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

2. 2 \u6e17\u900f\u6027<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

\u6211\u56fd\u3001WHO\u3001EMA \u548cFDA \u90fd\u652f\u6301\u91c7\u7528\u4eba\u4f53\u836f\u4ee3\u52a8\u529b\u5b66\u6570\u636e\u652f\u6301\u9ad8\u6e17\u900f\u6027\u3002<\/span><\/p>\n

\u6211\u56fd\u6307\u5bfc\u539f\u5219\u5141\u8bb8\u4f7f\u7528<\/span>\u6587\u732e\u6570\u636e\u8bc1\u660e\u9ad8\u6e17\u900f\u6027\u3002\u5bf9\u4e8e\u6587\u732e\u6570\u636e\u7684\u8ba4\u53ef\uff0c\u4e00\u822c<\/span>\u6765\u8bf4\uff0c\u539f\u7814\u8bf4\u660e\u4e66\u3001\u5ba1\u8bc4\u62a5\u544a\u7b49\u8d44\u6599\u4e2d\u7684\u4eba\u4f53\u836f\u4ee3\u52a8<\/span>\u529b\u5b66\u6570\u636e\u662f\u53ef\u63a5\u53d7\u7684\u3002<\/p>\n

\u4e5f\u53ef\u4ee5\u901a\u8fc7\u5f00\u5c55\u4e0e\u9759\u8109\u6ce8\u5c04\u5242\u6bd4\u8f83\u7684\u751f\u7269\u5229\u7528\u5ea6\u8bd5\u9a8c\u6216\u8d28\u91cf\u5e73\u8861\u7814\u7a76\u83b7\u5f97\u3002<\/span><\/p>\n

\u4e0d<\/span>\u8bba\u6587\u732e\u6570\u636e\u8fd8\u662f\u8bd5\u9a8c\u6570\u636e\uff0c\u90fd\u5e94\u6709\u8db3\u591f\u5145\u5206\u7684\u53d7\u8bd5\u8005<\/span>\u4e3a\u5438\u6536\u7a0b\u5ea6\u7684\u53ef\u9760\u63d0\u4f9b\u652f\u6301\u3002<\/span><\/p>\n

\u4e0b\u5217\u60c5\u51b5\u4efb\u610f\u4e00\u9879\u53ef\u4f5c\u4e3a\u9ad8\u6e17\u900f\u6027\u7684\u4f9d\u636e: <\/p>\n

\u2460\u7edd\u5bf9\u751f\u7269\u5229\u7528\u5ea6\u226585%; <\/span><\/p>\n

\u2461\u539f\u578b\u836f\u5c3f\u6392\u6cc4\u7387\u226585% \u6216\u5176<\/span>\u4ed6\u8d28\u91cf\u5e73\u8861\u6570\u636e\u8bc1\u660e\u5438\u6536\u226585%\uff0c\u4e14\u836f\u7269\u5728\u80c3\u80a0\u9053\u4e2d<\/span>\u7a33\u5b9a\u3002\u7edd\u5bf9\u751f\u7269\u5229\u7528\u5ea6\u548c\u539f\u578b\u836f\u5c3f\u6392\u6cc4\u7387\uff0c\u4e00\u822c\u6bd4\u8f83<\/span>\u5bb9\u6613\u4ece\u8bf4\u660e\u4e66\u4e2d\u83b7\u5f97\u5177\u4f53\u6570\u503c\uff0c\u5bf9\u4e8e\u8d28\u91cf\u5e73\u8861\u6570\u636e\u5f80<\/span>\u5f80\u96be\u4ee5\u754c\u5b9a\u3002<\/span><\/p>\n

EMA \u5bf9\u6b64\u4f5c\u4e86\u66f4\u8be6\u7ec6\u5730\u9610\u8ff0\uff0c\u91c7\u7528\u8d28\u91cf<\/span>\u5e73\u8861\u7814\u7a76\u8bc1\u660e\u836f\u7269\u5438\u6536\u7a0b\u5ea6\u65f6\uff0c\u7eb3\u5165\u5438\u6536\u4efd\u989d\u7684\u4ee3\u8c22<\/span>\u7269\u5e94\u786e\u4fdd\u662f\u5728\u5438\u6536\u540e\u4ee3\u8c22\u4ea7\u751f\u7684\u3002\u56e0\u6b64\uff0c\u5f53\u8ba1\u7b97\u5c3f\u4e2d<\/span>\u6392\u6cc4\u7684\u653e\u5c04\u6027\u91cf\u65f6\uff0c\u5e94\u786e\u4fdd\u836f\u7269\u5728\u80c3\u80a0\u9053\u4e2d\u6ca1\u6709\u964d\u89e3<\/span>\u6216\u4ee3\u8c22\u3002<\/span>\u2160<\/span><\/p>\n

\u578b\u6c27\u5316+ \u2161\u578b\u7ed3\u5408\u4ee3\u8c22\u7269\u53ea\u80fd\u53d1\u751f\u5728\u5438<\/span>\u6536\u540e\uff0c\u4e0d\u53ef\u80fd\u5728\u80c3\u80a0\u9053\u4e2d\u4ea7\u751f\u3002\u56e0\u6b64\uff0c\u5982\u679c\u539f\u578b\u836f\u5c3f<\/span>\u56de\u6536\u91cf\u3001\u5c3f\u4e0e\u7caa\u4fbf\u4e2d\u7684\u2160\u578b\u6c27\u5316\u548c\u2161\u578b\u7ed3\u5408\u4ee3\u8c22\u7269\u7684<\/span>\u603b\u548c\u226585%\uff0c\u8d28\u91cf\u5e73\u8861\u7814\u7a76\u7684\u6570\u636e\u53ef\u652f\u6301\u5b8c\u5168\u5438\u6536\u3002<\/span><\/p>\n

FDA \u548c\u6211\u56fd\u6307\u5357\u672a\u660e\u786e\u8981\u6c42\u4ee3\u8c22\u4ea7\u7269\u7684\u7c7b\u578b\uff0c\u4f46\u91c7\u7528\u8d28\u91cf\u5e73\u8861\u7814\u7a76\u6570\u636e\u65f6\uff0c\u5e94\u8bc1\u660e\u836f\u7269\u5728\u80c3\u80a0\u9053\u4e2d\u7a33\u5b9a\u3002<\/span><\/p>\n

\u4e00\u822c\u60c5\u51b5\u4e0b\uff0c\u4e0d\u80fd\u5c06\u7caa\u4fbf\u4e2d\u7684\u539f\u578b\u836f\u7269\u5f52\u5c5e\u4e8e\u88ab\u5438\u6536<\/span>\u8303\u56f4\u5185\uff0c\u56e0\u4e3a\u7caa\u4fbf\u4e2d\u7684\u539f\u578b\u836f\u7269\u5f88\u53ef\u80fd\u6765\u81ea\u4e8e\u80c3\u80a0\u9053<\/span>\u672a\u88ab\u5438\u6536\u7684\u90e8\u5206\u3002\u9664\u975e\u6709\u6570\u636e\u652f\u6301\u7caa\u4fbf\u4e2d\u7684\u539f\u578b\u836f<\/span>\u7269\u6765\u81ea\u80c6\u6c41\u6392\u6cc4\u3001\u80a0\u5206\u6ccc\uff0c\u6216\u8005\u67d0\u4e9b\u4e0d\u7a33\u5b9a\u7684\u4ee3\u8c22\u4ea7<\/span>\u7269\u901a\u8fc7\u5fae\u751f\u7269\u7684\u4f5c\u7528\u8f6c\u56de\u4e86\u539f\u578b\u3002<\/span><\/p>\n

\u5982\u679c\u65e0\u6cd5\u91c7\u7528\u4e0a\u8ff0\u4eba\u4f53\u6570\u636e\u8bc1\u660e\u9ad8\u6e17\u900f\u6027\u6027\uff0c\u4e5f\u53ef\u4ee5\u91c7\u7528\u5176\u4ed6\u65b9\u6cd5\u8bc1\u660e\u3002<\/span><\/p>\n

\u6211\u56fd\u6307\u5357\u3001WHO \u548cFDA \u6307<\/span>\u5357\u90fd\u5141\u8bb8\u91c7\u7528\u80a0\u9053\u901a\u900f\u6027\u6570\u636e\u8bc1\u660e\u9ad8\u6e17\u900f\u6027\u3002<\/span>EMA<\/span>\u6307\u5357\u672a\u63d0\u53ca\u662f\u5426\u53ef\u91c7\u7528\u5176\u4ed6\u65b9\u6cd5\u8bc1\u660e\u9ad8\u6e17\u900f\u6027\u3002<\/span><\/p>\n

\u80a0<\/span>\u9053\u901a\u900f\u6027\u6d4b\u5b9a\u65b9\u6cd5\u5305\u62ec\u4eba\u4f53\u4f53\u5185\u80a0\u9053\u704c\u6ce8\u7814\u7a76\u3001\u5408\u9002<\/span>\u7684\u52a8\u7269\u6a21\u578b\u8fdb\u884c\u7684\u4f53\u5185\u6216\u539f\u4f4d\u80a0\u9053\u704c\u6ce8\u7814\u7a76\u3001\u79bb\u4f53\u4eba<\/span>\u6216\u52a8\u7269\u80a0\u9053\u7ec4\u7ec7\u7684\u4f53\u5916\u6e17\u900f\u6027\u7814\u7a76\u4ee5\u53ca\u5355\u5c42\u4eba\u5de5\u57f9<\/span>\u517b\u4e0a\u76ae\u7ec6\u80de\u7684\u79bb\u4f53\u6e17\u900f\u6027\u7814\u7a76\u3002\u5176\u4e2d\uff0cCaco \uff0d 2 \u65b9\u6cd5<\/span>\u7531\u4e8e\u6210\u672c\u4f4e\u5ec9\u800c\u8f83\u5e38\u4f7f\u7528\u3002<\/span><\/p>\n

\u4f46\u8be5\u65b9\u6cd5\u53ea\u9002\u7528\u4e8e\u88ab\u52a8<\/span>\u8f6c\u8fd0\u7684\u836f\u7269( \u836f\u7269\u7684\u5916\u6392\u7387\u5e94\u5c0f\u4e8e2) \u3002\u5224\u65ad\u836f\u7269\u88ab<\/span>\u52a8\u8f6c\u8fd0\u7684\u4f9d\u636e:<\/span><\/p>\n

 \u2460\u836f\u7269\u5728\u4eba\u4f53\u5185\u5448\u7ebf\u6027\u836f\u4ee3( AUC\u3001<\/span>Cmax<\/span>\u4e0e\u76f8\u5173\u4e34\u5e8a\u5242\u91cf\u4e4b\u95f4\u5448\u7ebf\u6027) \u3002<\/span><\/p>\n

\u2461\u8868\u8fbe\u5df2\u77e5\u5916\u6392<\/span>\u8f6c\u8fd0\u4f53\u7684\u9002\u5f53\u68c0\u6d4b\u7cfb\u7edf\u8bc1\u5b9e\u65e0\u4e3b\u52a8\u8f6c\u8fd0\u673a\u5236\uff0c\u6bd4\u5982\u8bc1<\/span>\u5b9e\u6e17\u900f\u6027\u4e0d\u968f\u836f\u7269\u8d77\u59cb\u6d53\u5ea6\u53d8\u5316\u6216\u4e0e\u8f6c\u8fd0\u65b9\u5411\u65e0\u5173\u3002<\/span><\/p>\n

\u836f\u7269\u4e0d\u540c\u8d77\u59cb\u6d53\u5ea6\u4e00\u822c\u91c7\u7528\u6700\u9ad8\u5242\u91cf\u6eb6\u89e3\u4e8e250mL \u6c34\u4e2d\u7684\u836f\u7269\u6d53\u5ea6\u76840. 01\uff0c0. 1 \u548c1. 0 \u500d\u6d4b\u5b9a\u4f53\u5916<\/span>\u6e17\u900f\u6027\u3002<\/span><\/p>\n

\u4f53\u5916\u6e17\u900f\u6027\u4e0e\u8f6c\u8fd0\u65b9\u5411\u7684\u5173\u7cfb\u901a\u8fc7\u5916\u6392\u6bd4<\/span>\u8861\u91cf\uff0c\u5982\u5728\u7ed9\u5b9a\u7684\u836f\u7269\u6d53\u5ea6\u4e2d\uff0c\u7ec6\u80de\u819c\u57fa\u5e95\u4fa7\u7aef\uff0d \u9876<\/span>\u7aef\u65b9\u5411\u548c\u9876\u7aef\uff0d \u57fa\u5e95\u4fa7\u65b9\u5411\u7684\u8868\u89c2\u6e17\u900f\u7387( Papp) \uff1c<\/span>2\u3002<\/span><\/p>\n

\u5916\u6392\u8f6c\u8fd0\u4f53\u7684\u529f\u80fd\u6027\u8868\u8fbe\u5e94\u91c7\u7528\u53cc\u5411\u8f6c\u8fd0\u7814\u7a76\u8bc1<\/span>\u660e\u6240\u9009\u62e9\u5916\u6392\u8f6c\u8fd0\u5e95\u7269\u7684\u975e\u5bf9\u79f0\u6e17\u900f\u6027\u3002<\/span><\/p>\n

\u5916\u6392\u8f6c\u8fd0<\/span>\u5e95\u7269\u5305\u62ec\u5730\u9ad8\u8f9b\u3001\u957f\u6625\u78b1\u7b49\u88683 \u4e2d\u7684\u5e95\u7269\u3002<\/span><\/p>\n

\u91c7\u7528Caco \uff0d 2 \u7b49\u4f53\u5916\u6a21\u578b\u8fdb\u884c\u6e17\u900f\u6027\u7814\u7a76\u65f6\uff0c\u5e94<\/span>\u8fdb\u884c\u5145\u5206\u7684\u65b9\u6cd5\u5b66\u9a8c\u8bc1\uff0c\u5e76\u63d0\u4ea4\u65b9\u6cd5\u5b66\u9a8c\u8bc1\u6570\u636e\u3002<\/span><\/p>\n

\u63a8<\/span>\u8350\u4f7f\u7528\u6e17\u900f\u6027\u4e3a0\u3001\u4f4e( \uff1c 50%) \u3001\u4e2d( 50% \uff5e 84%) \u548c<\/span>\u9ad8( \u226585%) \u7684\u6a21\u578b\u836f\u7269\u5efa\u7acb\u8bd5\u9a8c\u6e17\u900f\u6027\u6570\u636e\u4e0e\u4eba\u4f53<\/span>\u5185\u836f\u7269\u5438\u6536\u7a0b\u5ea6\u7684\u987a\u5e8f\u5173\u7cfb\uff0c\u65b9\u6cd5\u5b66\u9a8c\u8bc1\u4e2d\u5e94\u4f7f\u7528\u8db3<\/span>\u591f\u6570\u91cf\u7684\u6a21\u578b\u836f\u7269\u8868\u5f81\u5168\u6e17\u900f\u8303\u56f4( \u63a8\u8350\u6bcf\u4e2a\u6e17\u900f\u7c7b<\/span>\u522b\u9ad8\u3001\u4e2d\u3001\u4f4e\u81f3\u5c115 \u4e2a\u6a21\u578b\u836f\u7269) \u3002\u6a21\u578b\u836f\u7269\u53ef\u9009\u7528\u6307<\/span>\u5bfc\u539f\u5219\u9644\u5f55\u4e2d\u63d0\u5230\u7684\u836f\u7269\uff0c\u89c1\u88683\u3002<\/span><\/p>\n

\"CDE\u6587\u7ae0|\u57fa\u4e8e\u751f\u7269\u836f\u5242\u5b66\u7cfb\u7edf\u5206\u7c7b\u7684\u751f\u7269\u8c41\u514d\u7684\u51e0\u70b9\u8003\u8651\"<\/p>\n

\u800c\u4e14\uff0c\u6bcf\u4e2a\u68c0\u6d4b\u6837<\/span>\u672c\u5e94\u81f3\u5c11\u5e73\u884c3 \u4efd\uff0c\u4ee5\u63d0\u4f9b\u53ef\u9760\u7684\u836f\u7269\u6e17\u900f\u6027\u4f30\u503c\u3002<\/span><\/p>\n

\u5efa\u7acb\u7684\u65b9\u6cd5\u5e94\u5bf9\u4f4e\u548c\u9ad8\u6e17\u900f\u6027\u836f\u7269\u5177\u6709\u533a\u5206\u529b\u3002\u5728\u8bd5\u9a8c\u524d\u548c\u8bd5\u9a8c\u540e\u5e94\u901a\u8fc7\u5408\u9002\u7684\u6307\u6807\u6765\u786e\u4fddCaco \uff0d 2<\/span>\u7ec6\u80de\u5355\u5c42\u7684\u5b8c\u6574\u6027\uff0c\u5e76\u989d\u5916\u901a\u8fc7\u6e17\u900f\u6027\u4e3a\u96f6\u7684\u836f\u7269<\/span>\u8bc1\u660e\u3002<\/span><\/p>\n

\u5bf9\u4e8e\u4eba\u4f53\u836f\u4ee3\u52a8\u529b\u5b66\u65b9\u6cd5\uff0c\u4e00\u822c\u6765\u8bf4\u5355\u4e00\u7684\u7814\u7a76\u5df2\u8db3\u591f\u5145\u5206\u3002\u82e5\u5355\u4e00\u7684\u6e17\u900f\u6027\u7814\u7a76\u4e0d\u8db3\u4ee5\u5145\u5206\u8bf4\u660e<\/span>\u836f\u7269\u7684\u6e17\u900f\u6027\u7c7b\u522b\uff0c\u5efa\u8bae\u91c7\u75282 \u79cd\u4e0d\u540c\u7684\u7814\u7a76\u65b9\u6cd5\u3002<\/span>\u5f53\u4e0d\u540c\u8bd5\u9a8c\u7c7b\u578b\u7684\u7814\u7a76\u7ed3\u679c\u5b58\u5728\u77db\u76fe\u65f6\uff0c\u5e94\u8003\u8651\u7528\u4eba<\/span>\u4f53\u6570\u636e\u66ff\u4ee3\u4f53\u5916\u6216\u52a8\u7269\u6570\u636e\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
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2. 3 \u4f53\u5916\u6eb6\u51fa<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

\u6279\u6b21\u8981\u6c42\u4f7f\u7528BCS \u8c41\u514d\u65b9\u6cd5\u65f6\uff0c\u4e00\u822c\u8981\u6c42\u9009\u62e9\u5546\u4e1a\u751f\u4ea7\u6279\u7684\u4ee3\u8868\u6279\u6b21( \u8981\u6c42\u540cBE \u6279\uff0c\u9664\u53e6\u6709\u89c4\u5b9a<\/span>\u5916\uff0c\u4e0d\u5c11\u4e8e10 \u4e07\u7247\u62161 \/10 \u751f\u4ea7\u91cf\uff0c\u4e8c\u8005\u53d6\u5176\u591a\u8005) \u3002<\/span><\/p>\n

\u5e94\u91c7\u7528\u836f\u5178\u89c4\u5b9a\u5668\u6750\u548c\u6b65\u9aa4\u8fdb\u884c\u65b9\u6cd5\u5b66\u9a8c\u8bc1\u3002<\/span>\u4ecb\u8d28\u8981\u6c42\u4e00\u822c\u60c5\u51b5\u4e0b\uff0c\u4f7f\u7528\u6eb6\u51fa\u4ecb\u8d28500 mL:<\/span><\/p>\n

\u24600. 1 mol\u00b7L \uff0d 1 HCl \u6216\u8005\u4e0d\u542b\u9176\u7684\u6a21\u62df\u80c3\u6db2; \u2461pH4. 5 \u7f13\u51b2\u6db2; ( 3) pH6. 8 \u7f13\u51b2\u6db2\u6216\u8005\u4e0d\u542b\u9176\u7684\u6a21\u62df\u80a0<\/span>\u6db2\u3002<\/span><\/p>\n

\u6709\u660e\u80f6\u5305\u8863\u7684\u80f6\u56ca\u548c\u7247\u5242\uff0c\u5219\u53ef\u4ee5\u91c7\u7528\u542b\u9176\u7684\u4eba<\/span>\u5de5\u80c3\u6db2\u548c\u80a0\u6db2\u3002\u5982\u679c\u6700\u4f4epH \uff0d \u6eb6\u89e3\u5ea6\u4e0e\u4e0a\u8ff0\u6761\u4ef6\u4e0d<\/span>\u540c\uff0c\u8fd8\u5e94\u589e\u52a0\u989d\u5916\u7814\u7a76\uff0c\u6216\u91c7\u7528\u7eaf\u6c34\u3002\u4e0d\u5e94\u6dfb\u52a0\u6709\u673a<\/span>\u6eb6\u5242\u548c\u8868\u9762\u6d3b\u6027\u5242\u3002<\/span><\/p>\n

\u53d8\u5f02\u9700\u8981\u81f3\u5c1112 \u4e2a\u5355\u4f4d\u5236\u5242\u8fdb\u884c\u6eb6\u51fa\u66f2\u7ebf\u7684\u6d4b\u5b9a\uff0c\u53d8\u5f02\u7cfb\u6570\u5728\u65e9\u671f\u6eb6\u51fa\u7684\u70b9( \u598210 min) \u65f6\u4e0d\u5e94\u8d85<\/span>\u8fc720%\uff0c\u5728\u5176\u4ed6\u65f6\u95f4\u70b9\u4e0d\u5e94\u8d85\u8fc710%\u3002\u53d8\u5f02\u7cfb\u6570\u592a<\/span>\u9ad8\u65f6\uff0c f2 \u56e0\u5b50\u7684\u8ba1\u7b97\u4e0d\u51c6\u786e\uff0c\u4e0d\u80fd\u5f97\u51fa\u6eb6\u51fa\u76f8\u4f3c\u7684\u7ed3<\/span>\u8bba\u3002<\/span><\/p>\n

\u6eb6\u51fa\u5ea6\u6d4b\u5b9a\u5e94\u8fdb\u884c\u65b9\u6cd5\u5b66\u9a8c\u8bc1\uff0c\u5e76\u63d0\u4ea4\u76f8\u5e94\u65b9\u6cd5<\/span>\u5b66\u9a8c\u8bc1\u6570\u636e\u3002<\/span><\/p>\n

\u6eb6\u51fa\u66f2\u7ebf\u76f8\u4f3c\u6027\u6bd4\u8f83\u6781\u5feb\u901f\u6eb6\u51fa( \u53d7\u8bd5\u5236\u5242\u4e0e\u53c2\u6bd4\u5236\u5242\u572815 min \u5185\u6eb6\u51fa\u5747\u8d85\u8fc785%) \u6216\u5feb\u901f\u6eb6\u51fa<\/span>\u4e14f2 \u56e0\u5b50\u226550\uff0c\u6bd4\u8f83\u76f8\u4f3c\u56e0\u5b50\u65f6\uff0c\u5e94\u81f3\u5c11\u5305\u62ec: \u24603 \u4e2a<\/span>\u975e\u96f6\u70b9; \u2461\u4e24\u5236\u5242\u4e4b\u95f4\u7684\u91c7\u6837\u70b9\u76f8\u540c; \u2462\u6bcf\u4e2a\u65f6\u95f4\u70b9<\/span>\u53d612 \u4e2a\u5355\u4f4d\u7684\u5747\u503c; \u2463\u5b58\u5728\u591a\u4e2a\u89c4\u683c\u7684\u54c1\u79cd\u7533\u8bf7<\/span>BCS \u8c41\u514d\u65f6\uff0c\u5e94\u6bd4\u8f83\u6bcf\u4e00\u89c4\u683c\u7684\u53d7\u8bd5\u5236\u5242\u4e0e\u76f8\u5e94\u53c2\u6bd4<\/span>\u5236\u5242\u7684\u6eb6\u51fa\u66f2\u7ebf\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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2. 4 \u5904\u65b9\u8981\u6c42<\/span><\/strong>
<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
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\u5bf9\u4e8e\u6240\u6709\u7684BE \u8c41\u514d\uff0c\u5e94\u8bc4\u4f30\u53d7\u8bd5\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u4e4b\u95f4\u8f85\u6599\u7684\u5dee\u5f02\u5bf9\u4f53\u5185\u5438\u6536\u6f5c\u5728\u7684\u5f71\u54cd\uff0c\u5e94\u8003\u8651\u836f<\/span>\u7269\u6027\u8d28\u548c\u8f85\u6599\u6548\u5e94\u3002\u5e94\u8003\u8651\u8f85\u6599\u5bf9\u5438\u6536\u7684\u5f71\u54cd\u5982\u5bf9<\/span>\u6eb6\u89e3\u5ea6\u3001\u80c3\u80a0\u52a8\u529b\u3001\u9a7b\u7559\u65f6\u95f4\u548c\u80a0\u6e17\u900f\u6027\u65b9\u9762\u7684\u5f71\u54cd\u3002<\/span><\/p>\n

\u53ef\u80fd\u5f71\u54cd\u5438\u6536\u7684\u8f85\u6599\u5305\u62ec\u7cd6\u9187\u7c7b( \u5982\u5c71\u68a8\u9187\u3001\u7518\u9732\u9187)<\/span>\u548c\u8868\u9762\u6d3b\u6027\u5242( \u5982\u5410\u6e2980\u3001\u6708\u6842\u9187\u786b\u9178\u94a0) \u3002<\/span><\/p>\n

\u8f85\u6599\u5bf9<\/span>\u5438\u6536\u7684\u5f71\u54cd\u5e94\u4ece\u8f85\u6599\u7528\u91cf\u3001\u8f85\u6599\u5bf9\u5438\u6536\u5f71\u54cd\u7684\u539f\u7406\u3001<\/span>\u836f\u7269\u5438\u6536\u6027\u8d283 \u4e2a\u65b9\u9762\u8bc4\u4f30\u3002<\/span><\/p>\n

\u8f85\u6599\u7684\u91cf\u5bf9\u5438\u6536\u5f71\u54cd<\/span>\u7684\u8bc1\u636e\u53ef\u4ee5\u63f4\u5f15\u6587\u732e\u3001\u666e\u904d\u8ba4\u77e5\u6216\u5df2\u5b8c\u6210\u7684BE \u7814\u7a76\u3002<\/span>\u5bf9\u4e8eBCS1 \u7c7b\u836f\u7269\uff0c\u5e94\u91cd\u70b9\u5173\u6ce8\u53ef\u80fd\u4f1a\u964d\u4f4e\u5438\u6536<\/span>\u901f\u5ea6\u548c\u7a0b\u5ea6\u7684\u8f85\u6599\u3002\u5438\u6536\u8f83\u6162\u4f46\u5b8c\u5168\u7684\u836f\u7269\uff0c\u4e5f\u5e94\u8003<\/span>\u8651\u8f85\u6599\u589e\u52a0\u5438\u6536\u901f\u5ea6\u7684\u60c5\u51b5\u3002\u5bf9\u4e8e\u5f71\u54cd\u836f\u7269\u5438\u6536\u7684<\/span>\u8f85\u6599\uff0c\u5e94\u4fdd\u6301\u4e0e\u53c2\u6bd4\u5236\u5242\u5bf9\u5e94\u8f85\u6599Q1 \u76f8\u540c\uff0cQ2 \u76f8\u4f3c\u3002<\/span><\/p>\n

\u5bf9\u4e8eQ2 \u76f8\u4f3c\u7684\u5224\u5b9a\uff0c\u5efa\u8bae\u4e0e\u53c2\u6bd4\u5236\u5242\u5bf9\u5e94\u8f85\u6599\u76f8\u6bd4<\/span>\u504f\u5dee\u5728\u00b1 10%\u4ee5\u5185\u3002\u5f53\u4f7f\u7528\u65b0\u7684\u8f85\u6599\uff0c\u6216\u8005\u5e38\u7528\u8f85\u6599<\/span>\u7528\u91cf\u8fdc\u8d85\u8fc7\u5e38\u7528\u91cf\u65f6\uff0c\u8981\u8865\u5145\u63d0\u4ea4\u8be5\u8f85\u6599\u7684\u4f7f\u7528\u662f\u5426<\/span>\u5f71\u54cd\u5236\u5242\u751f\u7269\u5229\u7528\u5ea6\u7684\u8bc1\u660e\u8d44\u6599\u3002\u91c7\u7528\u4e0e\u53e3\u670d\u6eb6\u6db2<\/span>\u5242\u8fdb\u884c\u76f8\u5bf9\u751f\u7269\u5229\u7528\u5ea6\u6bd4\u8f83\uff0c\u8bc1\u660e\u8f85\u6599\u5bf9\u5438\u6536\u7684\u5f71\u54cd<\/span>\u662f\u5176\u4e2d\u4e00\u79cd\u9014\u5f84\u3002<\/span><\/p>\n

\u4e5f\u53ef\u91c7\u7528\u5176\u4ed6\u6570\u636e\u8bc1\u660e\u8f85\u6599\u5bf9\u5438<\/span>\u6536\u7684\u5f71\u54cd\u3002<\/span><\/p>\n

\u5bf9\u4e8eBCS3 \u7c7b\u836f\u7269\uff0c\u8981\u6c42\u836f\u7269\u5236\u5242\u5fc5\u987b\u4e0e\u53c2\u6bd4\u5236\u5242\u542b\u6709\u76f8\u540c\u7684\u8f85\u6599\u7ec4\u6210\uff0c\u8f85\u6599\u7684\u7528\u91cf\u5e94\u4e0e\u53c2\u6bd4\u5236\u5242\u76f8<\/span>\u4f3c\u6216\u76f8\u540c\u3002<\/span><\/p>\n

\u5bf9\u4e8e\u8f85\u6599\u7528\u91cf\u76f8\u4f3c\u7684\u5224\u5b9a\uff0c\u53ef\u53c2\u8003\u300a\u5df2\u4e0a<\/span>\u5e02\u5316\u5b66\u836f\u54c1\u53d8\u66f4\u7814\u7a76\u7684\u6280\u672f\u6307\u5bfc\u539f\u5219( \u4e00) \u300b\u4e2d\u5173\u4e8e\u8f85<\/span>\u6599\u53d8\u66f4\u4e2d\u2161\u7c7b\u53d8\u66f4\u7684\u8981\u6c42\u3002\u5177\u4f53\u5982\u4e0b: \u4e0e\u539f\u7814\u5904\u65b9\u76f8<\/span>\u6bd4\uff0c\u4ee5\u4e0b\u6539\u53d8\u662f\u53ef\u4ee5\u63a5\u53d7\u7684: <\/span><\/p>\n

\u2460\u8f85\u6599\u6280\u672f\u7b49\u7ea7\u7684\u53d8\u5316;<\/span><\/p>\n

\u2461\u4ee5\u53c2\u6bd4\u5236\u5242\u7247\u91cd\u7684\u767e\u5206\u6bd4( w \/w) \u8868\u793a\uff0c\u5c0f\u4e8e\u6216\u7b49\u4e8e\u4ee5\u4e0b\u8303\u56f4\u7684\u8f85\u6599\u53d8\u5316\uff0c\u5982\u586b\u5145\u5242( \u00b1 10%) \uff0c\u5d29\u89e3\u5242\uff3b\u6dc0<\/span>\u7c89( \u00b16%) \uff0c\u5176\u4ed6( \u00b1 2%) \uff3d\uff0c\u7c98\u5408\u5242\uff3b( \u00b1 1%) \uff3d\uff0c\u6da6\u6ed1\u5242<\/span>\uff3b\u786c\u8102\u9178\u9499\u6216\u9541( \u00b1 0. 5%) \uff0c\u5176\u4ed6( \u00b1 2%) \uff3d\uff0c\u52a9\u6d41\u5242\uff3b\u6ed1<\/span>\u77f3\u7c89( \u00b1 2%) \uff0c\u5176\u4ed6( \u00b1 0. 2%) \uff3d\uff0c\u5305\u8863( \u00b1 2%) ; <\/span><\/p>\n

\u2462\u4e0e\u53c2<\/span>\u6bd4\u5236\u5242\u76f8\u6bd4\uff0c\u6240\u6709\u8f85\u6599\u6539\u53d8\u7684\u603b\u548c\u4e0d\u5e94\u8d85\u8fc7\u7247\u91cd10%\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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

\n
\n

\u751f\u7269\u8c41\u514d\u65f6\u9700\u8981\u6ce8\u610f\u7684\u95ee\u9898<\/strong><\/p>\n<\/section>\n<\/section>\n

<\/section>\n<\/section>\n<\/section>\n<\/section>\n
\n
\n
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3. 1 \u6570\u636e\u6765\u6e90<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

\u57fa\u4e8eBCS \u5206\u7c7b\u7684\u751f\u7269\u8c41\u514d\uff0c\u539f\u5219\u4e0a\uff0c\u4efb\u4f55\u5173\u952e\u6027\u6570\u636e\u5747\u5e94\u7531\u7814\u7a76\u8005\u5f00\u5c55\u7814\u7a76\u8bc1\u5b9e\u3002\u7531\u4e8e\u6587\u732e\u62a5\u9053\u7684<\/span>\u6570\u636e\u5177\u6709\u67d0\u4e9b\u5c40\u9650\u6027\uff0c\u4e0d\u5efa\u8bae\u7814\u7a76\u8005\u91c7\u7528\u8bf4\u660e\u4e66\u4ee5\u5916<\/span>\u7684\u6587\u732e\u6570\u636e\u4f5c\u4e3a\u5173\u952e\u652f\u6301\u8d44\u6599\u3002<\/span><\/p>\n

\u836f\u54c1\u8bf4\u660e\u4e66\u662f\u836f\u7269<\/span>\u7814\u7a76\u8fc7\u7a0b\u4e2d\u5927\u91cf\u8bd5\u9a8c\u8bc1\u5b9e\u7684\u7ed3\u679c\uff0c\u7ecf\u8fc7\u4e86\u5ba1\u8bc4\u90e8\u95e8\u7684<\/span>\u5ba1\u6838\uff0c\u662f\u53ef\u4f9b\u53c2\u8003\u7684\u53ef\u9760\u6587\u732e\u6570\u636e\u6765\u6e90\u3002<\/span><\/p>\n

\u6b64\u5916\uff0c\u67d0\u4e9b<\/span>\u60c5\u51b5\u4e0b\u8fd8\u53ef\u53c2\u8003\u76d1\u7ba1\u90e8\u95e8\u516c\u5f00\u53d1\u5e03\u7684\u6570\u636e\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
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3. 2 \u6570\u636e\u5185\u5bb9<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

\u6839\u636eBCS \u5206\u7c7b\uff0c\u5e94\u5206\u522b\u63d0\u4f9b\u6eb6\u89e3\u6027\u6570\u636e( 1 \u7c7b\u548c3\u7c7b) \u3001\u6e17\u900f\u6027\u6570\u636e( 1 \u7c7b) \u3001\u8bd5\u9a8c\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u7684\u6eb6\u51fa<\/span>\u6570\u636e( 1 \u7c7b\u548c3 \u7c7b) \u3001\u8bd5\u9a8c\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u4e4b\u95f4\u5404\u8f85\u6599<\/span>\u7528\u91cf\u5bf9\u6bd4( 1 \u7c7b\u548c3 \u7c7b) \u3002<\/span><\/p>\n

3. 2. 1 \u6eb6\u89e3\u6027\u6570\u636e<\/strong><\/p>\n

\u9ad8\u6eb6\u89e3\u6027\u652f\u6301\u6570\u636e\u5e94\u5305\u62ec\u4ee5\u4e0b\u4fe1\u606f: \u8bd5\u9a8c\u65b9\u6cd5\u7684\u63cf\u8ff0\uff0c\u5305\u62ec\u5206\u6790\u65b9\u6cd5\u548c\u7f13\u51b2\u6db2\u7684\u7ec4\u6210; \u836f\u7269\u6d3b\u6027\u6210\u5206<\/span>\u7684\u5316\u5b66\u7ed3\u6784\u3001\u5206\u5b50\u91cf\u3001\u6027\u8d28( \u9178\u3001\u78b1\u3001\u4e24\u6027\u6216\u4e2d\u6027) \u548c\u89e3<\/span>\u79bb\u5e38\u6570; \u6309\u6eb6\u5242pH \u503c\uff0c\u836f\u7269\u6eb6\u89e3\u5ea6\u548c\u6eb6\u89e3\u6700\u5927\u89c4\u683c\u5236<\/span>\u5242\u6240\u9700\u6eb6\u5a92\u91cf\u5217\u8868\uff0c\u603b\u7ed3\u8bd5\u9a8c\u7ed3\u679c( \u5e73\u5747\u503c\u3001\u6807\u51c6\u504f\u5dee<\/span>\u548c\u53d8\u5f02\u7cfb\u6570) ; \u5e73\u5747pH \uff0d \u6eb6\u89e3\u5ea6\u7279\u6027\u56fe\u7b49\u3002<\/span><\/p>\n

\u63d0\u4f9b\u7684\u6eb6<\/span>\u89e3\u6027\u6570\u636e\u5e94\u6ce8\u610f: <\/span><\/p>\n

\u2460\u91cd\u590d\u6b21\u6570\u5e94\u8db3\u4ee5\u5bf9\u7814\u7a76\u6570\u636e\u8fdb\u884c<\/span>\u7edf\u8ba1\u4f30\u8ba1; <\/span><\/p>\n

\u2461\u63d0\u4f9b\u836f\u54c1\u52a0\u5165\u7f13\u51b2\u6db2\u540e\u4ecb\u8d28\u7684pH \u503c\u662f<\/span>\u5426\u53d1\u751f\u53d8\u5316\u7684\u4fe1\u606f;<\/span><\/p>\n

\u2462\u63d0\u4f9b\u5206\u6790\u65b9\u6cd5\u7684\u9a8c\u8bc1\u62a5\u544a\u53ca\u76f8<\/span>\u5173\u65b9\u6cd5\u7684\u6807\u51c6\u64cd\u4f5c\u89c4\u7a0b( SOPs) ; \u2463\u63d0\u4f9b\u62a5\u544a\u6570\u636e\u7684\u7cbe<\/span>\u5bc6\u5ea6\u4fe1\u606f; <\/span><\/p>\n

\u2464\u5728\u5e73\u8861\u6761\u4ef6\u4e0b\u91c7\u96c6\u6570\u636e; <\/span><\/p>\n

\u2465\u542b\u91cf\u6d4b\u5b9a\u65b9<\/span>\u6cd5\u5e94\u7ecf\u8fc7\u65b9\u6cd5\u5b66\u9a8c\u8bc1\u5e76\u80fd\u533a\u5206API \u53ca\u5176\u964d\u89e3\u4ea7\u7269\u3002<\/span><\/p>\n

\u6240\u6709\u65b9\u6cd5\u5b66\u9a8c\u8bc1\u6570\u636e\u53ca\u542b\u91cf\u6d4b\u5b9a\u6570\u636e\u5747\u5e94\u63d0\u4ea4\u3002<\/p>\n

3. 2. 2 \u6e17\u900f\u6027\u6570\u636e<\/strong><\/p>\n

\u9ad8\u6e17\u900f\u6027\u652f\u6301\u6570\u636e\u5e94\u5305\u542b\u5bf9\u8bd5\u9a8c\u65b9\u6cd5\u7684\u63cf\u8ff0\uff0c\u5bf9\u4e8e\u4eba\u4f53\u836f\u4ee3\u52a8\u529b\u5b66\u7814\u7a76\uff0c\u7814\u7a76\u65b9\u6848\u8bbe\u8ba1\u548c\u4f7f\u7528\u65b9\u6cd5\u4fe1<\/span>\u606f\u5e94\u4e0e\u836f\u4ee3\u52a8\u529b\u5b66\u6570\u636e\u540c\u65f6\u63d0\u4ea4; \u5bf9\u4e8e\u76f4\u63a5\u6e17\u900f\u6027\u7814<\/span>\u7a76\u65b9\u6cd5\uff0c\u9700\u8981\u8bf4\u660e\u65b9\u6cd5\u7684\u9002\u7528\u6027\u3002<\/span><\/p>\n

Caco \uff0d 2 \u65b9\u6cd5\u7684\u65b9<\/span>\u6cd5\u5b66\u9a8c\u8bc1\u62a5\u544a\u5e94\u5305\u62ec\u6240\u9009\u62e9\u6a21\u578b\u836f\u7269\u5217\u8868\u53ca\u5176\u4eba\u4f53<\/span>\u5438\u6536\u7a0b\u5ea6\u6570\u636e\u3001\u6a21\u578b\u836f\u7269\u7684\u6e17\u900f\u6027\u6570\u503c( \u5305\u62ec\u5747\u503c\u3001\u504f<\/span>\u5dee\u3001\u53d8\u5f02) \u3001\u6a21\u578b\u836f\u7269\u7684\u6e17\u900f\u6027\u7c7b\u522b\u4ee5\u53ca\u5438\u6536\u7a0b\u5ea6\uff0d \u6e17<\/span>\u900f\u6027\u62df\u5408\u56fe\uff0c\u5e76\u6807\u8bb0\u6709\u4f4e\/\u9ad8\u6e17\u900f\u6027\u754c\u503c\u548c\u6240\u9009\u5185\u6807\u3002<\/span><\/p>\n

\u540c\u65f6\u5e94\u63cf\u8ff0\u7814\u7a76\u65b9\u6cd5\u3001\u4f9b\u7ed9\u6d4b\u836f\u7269\u6d53\u5ea6\u3001\u5206\u6790\u65b9\u6cd5\u3001\u6e17<\/span>\u900f\u6027\u8ba1\u7b97\u65b9\u6cd5\u3001\u5916\u6392\u8f6c\u8fd0\u4fe1\u606f\u3002<\/span><\/p>\n

\u6e17\u900f\u6027\u7814\u7a76\u4e2d\u7684\u836f\u7269<\/span>\u6d53\u5ea6\u5e94\u5408\u7406\u3002Caco \uff0d 2 \u65b9\u6cd5\u5e94\u5305\u62ec\u4e2d\u3001\u9ad8\u6e17\u900f\u6027\u6a21\u578b<\/span>\u836f\u7269\u4f5c\u4e3a\u5185\u6807\u4ee5\u8bc1\u660e\u65b9\u6cd5\u7684\u4e00\u81f4\u6027( \u4e0e\u88ab\u6d4b\u836f\u7269\u4e00\u8d77<\/span>\u6784\u6210\u704c\u6ce8\u6db2\u6216\u4f9b\u7ed9\u6db2) \u3002<\/p>\n

\u5185\u6807\u7269\u7684\u9009\u62e9\u5e94\u8003\u8651\u4e0e\u88ab\u6d4b\u7269\u7684\u76f8\u5bb9\u6027\uff0c\u5982\u4e0d\u80fd\u8868\u73b0\u51fa\u660e\u663e\u7684\u7406\u5316\u6216\u6e17\u900f\u76f8\u4e92\u4f5c<\/span>\u7528\u3002\u5f53\u65e0\u6cd5\u5728\u88ab\u6d4b\u836f\u7269\u7684\u6e17\u900f\u6027\u8bc4\u4f30\u4e2d\u52a0\u5165\u5185\u6807\u65f6\uff0c<\/span>\u5185\u6807\u5e94\u5728\u8bc4\u4ef7\u88ab\u6d4b\u836f\u7269\u76f8\u540c\u7684\u5355\u5c42\u7ec6\u80de\u4e2d\u6d4b\u5b9a\u3002<\/span><\/p>\n

\u5185<\/span>\u6807\u7269\u7684\u6e17\u900f\u6027\u5e94\u5728\u4e0d\u540c\u8bd5\u9a8c\u4e2d\u4e00\u81f4\uff0c\u5305\u62ec\u65b9\u6cd5\u5b66\u9a8c<\/span>\u8bc1\u3002\u8bd5\u9a8c\u7ed3\u675f\u540e\u5e94\u8bc4\u4f30\u836f\u7269\u7684\u5e73\u5747\u6d53\u5ea6\u548c\u5185\u6807\u56de\u6536<\/span>\u7387\u3002<\/span><\/p>\n

\u56de\u6536\u7387\uff1c 80%\uff0c\u5e94\u8bc4\u4f30\u8d28\u91cf\u5e73\u8861\u5305\u62ec\u7ec6\u80de\u819c\u4e0a\u7684<\/span>\u6b8b\u7559\u836f\u7269\u3002\u4e00\u822c\u9009\u62e9\u4ecb\u4e8e\u4e2d\uff0d \u9ad8\u6e17\u900f\u6027\u754c\u503c\u7684\u9ad8\u6e17<\/span>\u900f\u6027\u836f\u7269\u4f5c\u4e3a\u5185\u6807\uff0c\u4ee5\u786e\u5b9a\u8bd5\u9a8c\u836f\u7269\u7684BCS \u5206\u7c7b\u3002<\/span><\/p>\n

\u5f53<\/span>\u8bd5\u9a8c\u836f\u7269\u7684\u6e17\u900f\u6027\u7b49\u4e8e\u6216\u5927\u4e8e\u9ad8\u6e17\u900f\u6027\u5185\u6807\u65f6\uff0c\u53ef\u8bc1<\/span>\u5b9e\u5176\u4e3a\u9ad8\u6e17\u900f\u6027\u836f\u7269\u3002<\/span><\/p>\n

3. 2. 3 \u4f53\u5916\u6eb6\u51fa<\/strong><\/p>\n

\u6eb6\u51fa\u6570\u636e\u5e94\u5305\u542b\u68c0\u6d4b\u65b9\u6cd5\u7684\u4fe1\u606f\uff0c\u5305\u62ec\u5206\u6790\u65b9\u6cd5\u548c\u7f13\u51b2\u6db2\u7ec4\u6210\u3002\u5e38\u91ca\u5236\u5242\u6eb6\u51fa\u8bd5\u9a8c\u7684\u7b80\u8981\u63cf\u8ff0\u5305\u62ec<\/span>\u6279\u53f7\u3001\u6279\u91cf\u3001\u6709\u6548\u671f\u3001\u89c4\u683c\u548c\u7247\u91cd\u7b49; \u5217\u8868\u5448\u73b0\u6eb6\u51fa\u6570<\/span>\u636e\u7684\u5e73\u5747\u6eb6\u51fa\u91cf\u3001\u6eb6\u51fa\u8303\u56f4\u548c\u53d8\u5f02\u7cfb\u6570\uff0c\u56fe\u793a\u8868\u793a3<\/span>\u79cd\u4ecb\u8d28\u4e2d\u4e24\u79cd\u5236\u5242\u7684\u5e73\u5747\u6eb6\u51fa\u7279\u6027; \u63d0\u4f9b\u4e24\u79cd\u5236\u5242\u5728<\/span>3 \u79cd\u4ecb\u8d28\u4e2d\u7684\u6eb6\u51fa\u7279\u6027\u76f8\u4f3c\u6027\u7684\u652f\u6301\u6027\u6570\u636e\u7b49\u3002\u6eb6\u51fa<\/span>\u5ea6\u7814\u7a76\u6570\u636e\u4e2d\u5e94\u8be6\u7ec6\u63cf\u8ff0\u6eb6\u51fa\u65b9\u6cd5\u53c2\u6570\uff0c\u4f8b\u5982\u4f53\u79ef\u3001<\/span>\u901f\u5ea6\u3001\u4ee5\u53ca\u8bbe\u5907\u578b\u53f7\u7b49\uff0c\u5e76\u63d0\u4f9b\u5206\u6790\u65b9\u6cd5\u7684\u9a8c\u8bc1\u62a5\u544a<\/span>\u53ca\u76f8\u5173\u65b9\u6cd5\u7684SOPs\u3002<\/span><\/p>\n

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3.3 \u4e0d\u80fd\u57fa\u4e8eBCS \u5206\u7c7b\u8c41\u514d\u7684\u60c5\u51b5<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u5316\u5408\u7269\u7684\u6210\u76d0\u5f62<\/span>\u5f0f\u53d1\u751f\u4e86\u6539\u53d8\uff0c\u5219\u6eb6\u89e3\u6027\u3001\u6e17\u900f\u6027\u3001\u6eb6\u51fa\u5ea6\u548c\u80c3\u80a0\u9053\u7a33<\/span>\u5b9a\u6027\u6570\u636e\u5e94\u91cd\u65b0\u8fdb\u884c\u8003\u5bdf\u3002<\/span><\/p>\n

\u603b\u4e4b\uff0c\u57fa\u4e8eBCS \u7684\u751f\u7269\u8c41\u514d\u5e94\u614e\u91cd\u8bc4\u4ef7\u5404\u9879\u6307\u6807\u3002\u672c\u6587\u5185\u5bb9\u4ec5\u4ece\u5b66\u672f\u89d2\u5ea6\u8ba8\u8bba\u751f\u7269\u8c41\u514d\u8bc4\u4ef7\u7684\u5173<\/span>\u6ce8\u70b9\uff0c\u4e0d\u4f5c\u4e3a\u6ce8\u518c\u7533\u62a5\u7684\u4f9d\u636e\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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

\"CDE\u6587\u7ae0|\u57fa\u4e8e\u751f\u7269\u836f\u5242\u5b66\u7cfb\u7edf\u5206\u7c7b\u7684\u751f\u7269\u8c41\u514d\u7684\u51e0\u70b9\u8003\u8651\"<\/section>\n

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\u8be6\u89c1\u539f\u6587\uff0c<\/p>\n

\u4e2d\u56fd\u4e34\u5e8a\u836f\u7406\u5b66\u6742\u5fd7, \u7b2c35 \u5377\u7b2c3 \u671f2019 \u5e742 \u6708<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u514d\u8d23\u58f0\u660e<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u672c\u516c\u4f17\u53f7\u53d1\u5e03\u7684\u6587\u7ae0\u5747\u4e3a\u4fc3\u8fdb\u5236\u836f\u754c\u540c\u884c\u7684\u4ea4\u6d41\u4e0e\u5b66\u4e60\uff1b\u5185\u5bb9\u7531\u5c0f\u7f16\u67e5\u9605\u6587\u732e\u9009\u53d6\uff0c\u6392\u7248\u4e0e\u7f16\u8f91\u4e3a\u539f\u521b\u3002\u5982\u8f6c\u8f7d\uff0c\u8bf7\u6ce8\u660e\u6765\u6e90\u3002<\/p>\n

\u9009\u53d6\u7684\u6587\u7ae0\u5df2\u660e\u786e\u6ce8\u660e\u6765\u6e90\u548c\u4f5c\u8005\uff0c\u7248\u6743\u5f52\u539f\u4f5c\u8005\u6240\u6709\uff0c\u5982\u6d89\u53ca\u4f5c\u54c1\u5185\u5bb9\u3001\u7248\u6743\u6216\u5176\u4ed6\u95ee\u9898\uff0c\u8bf7\u8054\u7cfb\u6211\u4eec\u8fdb\u884c\u5220\u9664\u3002<\/strong><\/p>\n

\u6587\u7ae0\u5185\u5bb9\u4e3a\u4f5c\u8005\u89c2\u70b9\uff0c\u4e0d\u4ee3\u8868\u672c\u516c\u4f17\u53f7\u7acb\u573a\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u6587\u7ae0\u641c\u7d22<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u672c\u516c\u4f17\u53f7\u5f00\u901a\u5f80\u671f\u6587\u7ae0\u4efb\u610f\u641c\u529f\u80fd\u5566
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\u5728\u516c\u4f17\u53f7\u83dc\u5355\u680f\u4e2d\u8f93\u5165\u201c\u641c\u7d22\u201d\uff0c\u5373\u53ef\u641c\u7d22\u5f80\u671f\u5fae\u4fe1\u5185\u5bb9<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\"CDE\u6587\u7ae0|\u57fa\u4e8e\u751f\u7269\u836f\u5242\u5b66\u7cfb\u7edf\u5206\u7c7b\u7684\u751f\u7269\u8c41\u514d\u7684\u51e0\u70b9\u8003\u8651\"<\/section>\n<\/section>\n<\/section>\n<\/section>\n


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

\u57fa\u4e8e\u751f\u7269\u836f\u5242\u5b66\u7cfb\u7edf\u5206\u7c7b\u7684\u751f\u7269\u8c41\u514d\u7684 \u51e0\u70b9\u8003\u8651 Some considerations about biowai […]<\/p>\n","protected":false},"author":1,"featured_media":98175,"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\/98174"}],"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=98174"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/98174\/revisions"}],"predecessor-version":[{"id":98190,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/98174\/revisions\/98190"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/98175"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=98174"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=98174"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=98174"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}