{"id":59486,"date":"2018-10-11T01:00:00","date_gmt":"2018-12-07T02:45:34","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/12\/07\/040c68aeb8\/"},"modified":"2018-12-07T10:45:36","modified_gmt":"2018-12-07T02:45:36","slug":"040c68aeb8","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/59486\/","title":{"rendered":"\u5f02\u70df\u80bc\u7247\u7b49\u751f\u7269\u7b49\u6548\u6027\u8c41\u514d\uff0c\u673a\u9047 or \u98ce\u9669\uff1f"},"content":{"rendered":"
\n

\u53bb\u5e74\u5728\u516c\u4f17\u53f7\u4e0a\u53d1\u8868\u4e86\u4e00\u7bc7\u5173\u4e8e\u5f02\u70df\u80bcBE\u8c41\u514d\u7684\u6587\u732e\uff1a\u3010\u6848\u4f8b\u63ed\u79d8\u3011\u901f\u91ca\u56fa\u4f53\u53e3\u670d\u5236\u5242\u7684\u751f\u7269\u7b49\u6548\u8c41\u514d\u4e13\u8bba<\/a>\uff1a\u5f02\u70df\u80bc\uff08\u70b9\u51fb\u53ef\u8df3\u8f6c\u539f\u6587\uff09\uff0c\u7ed9\u5927\u5bb6\u63d0\u4f9b\u4e86\u4e00\u4e9b\u53c2\u8003\uff0c\u4eca\u5929\uff0c\u6211\u4eec\u8f6c\u8f7d\u4e00\u7bc7\u516c\u4f17\u53f7\uff1a\u4e34\u5e8a\u8bd5\u9a8c\u65f6\u4e8b\u8bc4\u8bba\u4e0a\u53d1\u8868\u7684\u6587\u7ae0\uff0c\u518d\u6b21\u63a2\u8ba8\u5f02\u70df\u80bc\u8c41\u514dBE\u7684\u8bdd\u9898\u3002<\/p>\n

\u6587\u7ae0\u539f\u9898\u76ee\uff1a\u4e71\u5f39\u7cfb\u5217|\u5f02\u70df\u80bc\u7247\u7b49\u751f\u7269\u7b49\u6548\u6027\u8c41\u514d\uff0c\u662f\u5426\u7ed9\u4e00\u81f4\u6027\u8bc4\u4ef7\u89c2\u671b\u8005\u4e00\u4e1d\u5e0c\u671b\uff1f\u8fd8\u662f\u5bf9\u201c\u6295\u673a\u8005\u201d\u7684\u8912\u8d4f\uff1f<\/p>\n

\u4f5c\u8005\uff1a Pipigo2016<\/p>\n


<\/p>\n

\n
<\/p>\n
\n

\u5f02\u70df\u80bc\u7247\u7b49\u751f\u7269\u7b49\u6548\u6027\u8c41\u514d\uff0c\u662f\u5426\u7ed9\u4e00\u81f4\u6027\u8bc4\u4ef7\u89c2\u671b\u8005\u4e00\u4e1d\u5e0c\u671b\uff1f\u8fd8\u662f\u5bf9\u201c\u6295\u673a\u8005\u201d\u7684\u8912\u8d4f\uff1f<\/span><\/strong>
<\/p>\n<\/section>\n

\n

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

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\u6211\u4eec\u5c31\u5f02\u70df\u80bc\u8fd9\u4e2a\u4ea7\u54c1\u6765\u8ba8\u8bba\u4e0b\u8c41\u514dBE\u7684\u6ce8\u518c\u98ce\u9669\u5728\u54ea\u91cc\uff1f<\/span><\/p>\n

\u4e00\u3001BE\u8c41\u514d\u5145\u5206\u6027<\/span><\/strong><\/p>\n

1      <\/span><\/span><\/strong>BCS<\/span><\/strong>\u5206\u7c7b<\/span><\/strong><\/p>\n

\u5f02\u70df\u80bc\u7684BCS\u5206\u7c7b\u4e3aI\/III\u7c7b\uff08WHO\uff0cNICHD\uff0cFDA\uff09[3,4]<\/sup>\u3002<\/span><\/p>\n

1.1  <\/span><\/span><\/strong>\u6eb6\u89e3\u6027\uff1a<\/span><\/strong><\/p>\n

\u6839\u636e\u6587\u732e[5-7]<\/sup>\u53ef\u77e5\u5f02\u70df\u80bc\u7684\u6700\u5927\u89c4\u683c\u80fd\u5728pH\u503c1.0\uff5e6.8\u7684\u8303\u56f4\u5185\u3001\u5b8c\u5168\u6eb6\u89e3\u5728\u5c0f\u4e8e250ml\u7684\u6c34\u6eb6\u6027\u7f13\u51b2\u4ecb\u8d28\u4e2d\uff08\u5982\u4e0b\u56fe\uff09\uff0c\u6ee1\u8db3BCS\u5bf9\u4e8e\u9ad8\u6eb6\u89e3\u6027\u7684\u8981\u6c42\uff0c\u5f02\u70df\u80bc\u53ef\u5f52\u4e3a\u201c\u9ad8\u6eb6\u89e3\u6027\u201d\u3002<\/span><\/p>\n

\"\u5f02\u70df\u80bc\u7247\u7b49\u751f\u7269\u7b49\u6548\u6027\u8c41\u514d\uff0c\u673a\u9047<\/p>\n

1.2  <\/span><\/span><\/strong>\u6e17\u900f\u6027\uff1a<\/span><\/strong><\/p>\n

API<\/span><\/strong>\u6e17\u900f\u6027\u5206\u7c7b\u53ef\u4ee5\u901a\u8fc7\u4ee5\u4e0b\u8bd5\u9a8c\u786e\u5b9a[8]<\/sup>\uff1a<\/span><\/strong><\/p>\n

    \n
  • \n

    \u4eba\u4f53\u5185\u836f\u4ee3\u52a8\u529b\u5b66\u7814\u7a76\uff1a\u8d28\u91cf\u5e73\u8861\u7814\u7a76\u3001\u7edd\u5bf9\u751f\u7269\u5229\u7528\u5ea6\u7814\u7a76\uff08BA\uff09<\/span><\/p>\n<\/li>\n<\/ul>\n

    \u8d28\u91cf\u5e73\u8861\u6d4b\u5b9a\u7684\u7ed3\u679c\u6216BA\uff0c\u663e\u793a\u5728\u4f53\u5185\u7684\u5438\u6536\u7a0b\u5ea6\u226585%\u4ee5\u4e0a\uff08\u5e76\u4e14\u6709\u8bc1\u636e\u8bc1\u660e\u836f\u7269\u5728\u80c3\u80a0\u9053\u7a33\u5b9a\u6027\u826f\u597d\uff09\uff0c\u226585%\u7684\u836f\u7269\u4ee5\u539f\u578b\u836f\u7684\u5f62\u5f0f\u4ece\u5c3f\u6db2\u4e2d\u6392\u51fa\u7b49\uff0c\u5219\u53ef\u8bf4\u660e\u8be5\u836f\u7269\u5177\u6709\u9ad8\u6e17\u900f\u6027\u3002<\/span><\/p>\n

      \n
    • \n

      \u80a0\u9053\u901a\u900f\u6027\u68c0\u6d4b\u65b9\u6cd5\uff1a\uff081\uff09\u4eba\u4f53\u4f53\u5185\u80a0\u9053\u704c\u6ce8\u7814\u7a76\uff1b\uff082\uff09\u4f7f\u7528\u5408\u9002\u7684\u52a8\u7269\u6a21\u578b\uff0c\u4f53\u5185\u6216\u539f\u4f4d\u80a0\u9053\u704c\u6ce8\u7814\u7a76\uff1b\uff083\uff09\u79bb\u4f53\u4eba\u6216\u52a8\u7269\u80a0\u9053\u7ec4\u7ec7\u7684\u4f53\u5916\u6e17\u900f\u6027\u7814\u7a76\uff1b\uff084\uff09\u5355\u5c42\u4eba\u5de5\u57f9\u517b\u4e0a\u76ae\u7ec6\u80de\u7684\u79bb\u4f53\u6e17\u900f\u6027\u7814\u7a76\u3002<\/span><\/p>\n<\/li>\n<\/ul>\n

      \u5f02\u70df\u80bc\u80a0\u9053\u901a\u900f\u6027\u6570\u636e\uff1a<\/span><\/strong><\/p>\n

      \u5f02\u70df\u80bc\u76ee\u524d\u65e0\u80a0\u9053\u704c\u6ce8\u3001\u79bb\u4f53\u80a0\u9053\u7ec4\u7ec7\u7684\u4f53\u5916\u6e17\u900f\u6027\u53caCaco-2\u7ec6\u80de\u6e17\u900f\u6027\u7814\u7a76[7]<\/sup>\u3002<\/span><\/p>\n

      \u5f02\u70df\u80bc\u4eba\u4f53\u5185\u836f\u4ee3\u52a8\u529b\u5b66\u7814\u7a76\u6570\u636e\uff1a<\/span><\/strong><\/p>\n

      \u636e\u62a5\u9053\u5f02\u70df\u80bc\u53e3\u670d\u540e\u6613\u4e8e\u4ece\u80a0\u9053\u4e2d\u5438\u6536\u3002Mariappan\u7b49\u548cKakemi\u7b49[9,10]<\/sup>\u5728\u5927\u9f20\u7814\u7a76\u4e2d\u53d1\u73b0\u5f02\u70df\u80bc\u5728\u80c3\u4e2d\u6e17\u900f\u6027\u5dee\uff0c\u5176\u4e3b\u8981\u5438\u6536\u90e8\u4f4d\u4e3a\u80a0\u9053\u30021979\u5e74\uff0cKleber\u7b49[11]<\/sup>\u62a5\u9053\u5728\u7ed3\u6838\u75c5\u60a3\u8005\u4e2d\u7edd\u5bf9BA\u4e3a91\uff05\u00b110\uff05<\/span>\uff0c\u5176\u4e2d\u51e0\u4eba\u6709\u80c3\u5207\u9664\u624b\u672f\u53f2\uff0c\u6ee1\u8db3\u9ad8\u6e17\u900f\u6027\u836f\u7269\u7684\u8981\u6c42\uff08FDA BA\u4e3a\u226590%\uff09\u3002\u540c\u5e74\uff0cPolk\u7b49[12]<\/sup>\u8bc1\u660e\u4e86\u5373\u4f7f\u5728\u5404\u79cd\u5916\u79d1\u624b\u672f\u540e\uff0c\u5982\u7a7a\u80a0\u65c1\u8def\u672f\uff0c\u5f02\u70df\u80bc\u7684\u66b4\u9732\u91cf\u548cCmax<\/sub>\u672a\u53d1\u751f\u6539\u53d8\u3002\u6b64\u5916\uff0c\u5f02\u70df\u80bc\u7684Tmax<\/sub>\u4e3a1\uff5e2h\uff0c\u540c\u6837\u53cd\u6620\u5176\u5177\u6709\u8f83\u597d\u7684\u6e17\u900f\u6027<\/span>\u3002<\/span><\/p>\n

      \u4f46\u65e9\u57281952\u5e74\u5f00\u5c55\u7684\u4e00\u9879\u7814\u7a76\u4e2d\uff0c\u6210\u5e74\u665a\u671f\u6216\u4e2d\u5ea6\u665a\u671f\u7ed3\u6838\u75c5\u60a3\u8005\u53e3\u670d3mg\/kg\u5242\u91cf\u7684\u5f02\u70df\u80bc\uff0c24h\u540e\u7684\u5c3f\u6db2\u56de\u6536\u7387\u4e3a48\uff05~70\uff05\uff0c\u672a\u6ee1\u8db3\u9ad8\u6e17\u900f\u6027\u8981\u6c42<\/span>\u7684\u226585%\u7684\u836f\u7269\u4ee5\u539f\u578b\u836f\u7684\u5f62\u5f0f\u4ece\u5c3f\u6db2\u4e2d\u6392\u51fa[13]<\/sup>\u3002<\/span><\/p>\n

      \u6b64\u5916\uff0cKasim\u7b49[14]<\/sup>\u6d4b\u5f97\u5f02\u70df\u80bc\u7684ClogP\u00ae\u548clogP\u503c\u4e3a0.67\u548c0.64\uff0c\u5747\u4f4e\u4e8e\u9ad8\u6e17\u900f\u6a21\u578b\u836f\u7269\u7f8e\u6258\u6d1b\u5c14\uff0c\u5373\u8ba4\u4e3a\u5176\u4e3a\u201c\u4f4e\u6e17\u900f\u6027\u201d<\/span>\uff08\u6e17\u900f\u6027\u7684\u8f85\u52a9\u53c2\u8003\u65b9\u6cd5\uff09<\/span><\/p>\n

      WHO\u3001FDA\u7b49\u8ba4\u4e3a\u5f02\u70df\u80bc\u65e0\u660e\u786e\u7684\u6e17\u900f\u6027\u652f\u6301\u6027\u6570\u636e\uff0c\u4e14\u90e8\u5206\u6587\u732e\u7ed3\u8bba\u77db\u76fe\uff0c\u6e17\u900f\u6027\u5206\u7c7b\u5904\u4e8e\u4f4e\u6e17\u900f\u548c\u9ad8\u6e17\u900f\u8fb9\u754c\uff0c\u5c06\u5f02\u70df\u80bcBCS\u5206\u7c7b\u5212\u5206\u4e3aI\u7c7b\/III\u7c7b[3,4]<\/sup><\/span>\u3002<\/span><\/p>\n

      2      <\/span><\/span><\/strong>\u8f85\u6599\uff1a\u82e5\u542b\u6709\u4e73\u7cd6\uff0c\u5219\u5bf9\u4e8eBE\u8c41\u514d\u6709\u8f83\u5927\u6ce8\u518c\u98ce\u9669\u3002<\/span><\/strong><\/p>\n

      \u5bf9\u4e8eBCS I\u7c7b\u7684\u836f\u7269\uff0c\u9664\u4e86\u9700\u8981\u8bc1\u660e\u836f\u7269\u5177\u6709\u9ad8\u6eb6\u89e3\u6027\u3001\u9ad8\u6e17\u900f\u6027\u5916\u3001\u5feb\u901f\u6eb6\u51fa\uff0c\u8fd8\u9700\u6ee1\u8db3\u5236\u5242\u4e2d\u4e0d\u542b\u6709\u5f71\u54cd\u4e3b\u836f\u6210\u5206\u5438\u6536\u901f\u7387\u548c\u5438\u6536\u7a0b\u5ea6\u7684\u4efb\u4f55\u8f85\u6599\u3002\u5f02\u70df\u80bc\u53ef\u4ee5\u4e0e\u4e73\u7cd6\u548c\/\u6216\u5176\u4ed6\u8131\u6c27\u8461\u8404\u7cd6\u76f8\u4e92\u4f5c\u7528\uff0c\u5f62\u6210\u7f29\u5408\u7269\uff0c\u4ece\u800c\u5f71\u54cd\u5f02\u70df\u80bc\u7684\u6e17\u900f\u548c\u5438\u6536\uff0c\u4f46\u8fd9\u79cd\u53cd\u5e94\u7a0b\u5ea6\u4f3c\u4e4e\u4f9d\u8d56\u4e8e\u4e73\u7cd6\u542b\u91cf\uff0c\u5728Sved\u7814\u7a76\u4e2d[17]<\/sup>\uff0c\u6d4b\u8bd5\u7684\u4e09\u79cd\u5f02\u70df\u80bc\u5236\u5242\u4e2d\u6709\u4e24\u79cd\u542b\u6709\u7684\u4e73\u7cd6\u91cf\u5c0f\u4e8e4\uff05\uff0c\u7ed3\u679c\u53d1\u73b0\u4e09\u79cd\u5236\u5242\u7684\u751f\u7269\u5229\u7528\u5ea6\u6ca1\u6709\u663e\u8457\u5dee\u5f02\u3002\u4f46\u82e5\u5236\u5242\u4e2d\u5b58\u5728\u4e73\u7cd6\u6216\u5176\u4ed6\u8131\u6c27\u8461\u8404\u7cd6\u7684\u8f85\u6599\uff0c\u5bf9BE\u4f53\u5185\u7b49\u6548\u4f9d\u65e7\u5b58\u5728\u7740\u4e00\u5b9a\u7684\u98ce\u9669\uff0cBecker\u7b49[7]<\/sup>\u8ba4\u4e3aBE\u8c41\u514d\u4e0d\u9002\u7528\u4e8e\u542b\u6709\u5df2\u77e5\u6216\u6000\u7591\u4e0eAPI\u5f62\u6210\u7f29\u5408\u7269\u7684\u8f85\u6599\uff08\u5982\u4e73\u7cd6\u6216\u5176\u4ed6\u8131\u6c27\u8461\u8404\u7cd6\uff09\u7684\u5f02\u70df\u80bc\u5236\u5242\uff0c<\/span><\/p>\n

      2017\u5e748\u67089\u65e5\u7684\u4eff\u5236\u836f\u53c2\u6bd4\u5236\u5242\u76ee\u5f55\uff08\u7b2c\u4e94\u6279\uff09[18]<\/sup>\u63a8\u8350\u7684\u53c2\u6bd4\u5236\u5242\u4e3aSandoz\u516c\u53f8\u7684\u5f02\u70df\u80bc\u7247\uff0c\u4f46\u6b64\u54c1\u79cd\u7684\u8f85\u6599\u4e2d\u542b\u6709\u4e73\u7cd6[19]<\/sup>\uff0c\u56e0\u8f85\u6599-\u4e73\u7cd6\u7684\u5b58\u5728\u5bf9\u4e8e\u901a\u8fc7BCS I\u7c7b\u8c41\u514d\u5b58\u5728\u7740\u4e00\u5b9a\u7684\u98ce\u9669\u3002\u800c\u57282018\u5e745\u67083\u65e5\u7684\u4eff\u5236\u836f\u53c2\u6bd4\u5236\u5242\u76ee\u5f55\uff08\u7b2c\u5341\u56db\u6279\uff09[20]<\/sup>\u4e2d\u589e\u8865\u4e86Teva\u516c\u53f8\u7684\u5f02\u70df\u80bc\u7247\uff0c\u6b64\u54c1\u79cd\u8f85\u6599\u4e2d\u65e0\u4e73\u7cd6[21]<\/sup>\uff0c\u56e0\u6b64\uff0c\u82e5\u4f01\u4e1a\u7684\u5f02\u70df\u80bc\u7247\u4e2d\u542b\u6709\u4e73\u7cd6\uff0c\u5219\u5bf9\u4e8eBE\u8c41\u514d\u5b58\u5728\u8f83\u5927\u7684\u6ce8\u518c\u98ce\u9669\u3002<\/span><\/strong><\/span><\/p>\n

      \u5bf9\u4e8eBCS III\u7c7b\u9664\u4e86\u9700\u8981\u8bc1\u660e\u836f\u7269\u5177\u6709\u9ad8\u6eb6\u89e3\u6027\u3001\u975e\u5e38\u5feb\u901f\u6eb6\u51fa\uff0c\u8fd8\u9700\u6ee1\u8db3\u4eff\u5236\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u5e94\u5904\u65b9\u5b8c\u5168\u76f8\u540c\uff0c\u5404\u7ec4\u6210\u7528\u91cf\u76f8\u4f3c\uff0c\u5f53\u653e\u5927\u751f\u4ea7\u548c\u4e0a\u5e02\u540e\u53d8\u66f4\u65f6\uff0c\u5236\u5242\u5904\u65b9\u4e5f\u5e94\u5b8c\u5168\u76f8\u540c\u3002<\/span><\/p>\n

      \u9274\u4e8e\u6b64\u4ea7\u54c1\u51fa\u4e8eI\u7c7b\/III\u7c7b\u4e4b\u95f4\uff0c\u5982\u4f55\u8bc1\u660e\u81ea\u5df1\u7684\u5904\u65b9\u4e0e\u53c2\u6bd4\u5236\u5242\u5904\u65b9\u76f8\u4f3c\u4e5f\u4f1a\u6210\u4e3a\u6ce8\u518c\u7684\u98ce\u9669\u70b9\u3002<\/span><\/p>\n

       <\/span><\/strong><\/p>\n

      \u4e8c\u3001\u56fd\u5185\u5916BE\u8bd5\u9a8c<\/span><\/strong><\/p>\n

      \u867d\u5f02\u70df\u80bc\u7247\u53ef\u8c41\u514dBE\uff0c\u4f46\u56fd\u5916\u4ecd\u6709\u5f88\u591a\u4eff\u5236\u836f\u4e0a\u5e02\u7533\u8bf7\u65f6\u8fdb\u884c\u4e86BE\u8bd5\u9a8c\uff08\u8be6\u89c1\u4e0b\u8868\uff09\uff0c\u6b64\u4fa7\u9762\u4e5f\u8bf4\u660e\u4e86\u4e00\u4e2a\u95ee\u9898\uff0c\u8c41\u514dBE\u6ce8\u518c\u7684\u98ce\u9669\u8fd8\u662f\u5f88\u5927\u7684\uff0c\u4e0d\u80fd\u60f3\u7684\u592a\u7b80\u5355\uff0c\u5145\u5206\u8c03\u7814\uff0c\u62ff\u51fa\u5145\u5206\u7684\u8bc1\u636e\u624d\u662f\u738b\u9053\u3002<\/span><\/p>\n\n\n\n\n\n\n
      \n

      \u65f6\u95f4<\/span><\/p>\n<\/td>\n

      		\n

      \u56fd\u5bb6<\/span><\/p>\n<\/td>\n

      		\n

      \u8bd5\u9a8c\u8bbe\u8ba1<\/span><\/p>\n<\/td>\n

      		\n

      \u6837\u672c\u91cf<\/span><\/p>\n<\/td>\n

      		\n

      \u53c2\u6bd4\u5236\u5242<\/span><\/p>\n<\/td>\n

      		\n

      Tmax<\/span><\/p>\n<\/td>\n

      		\n

      \u7ed3\u8bba<\/span><\/p>\n<\/td>\n

      		\n

      \u5176\u4ed6<\/span><\/p>\n<\/td>\n<\/tr>\n

      \n

      2016<\/span><\/p>\n<\/td>\n

      		\n

      \u5370\u5ea6[22]<\/sup><\/span><\/p>\n<\/td>\n

      		\n

      2*2 \u7a7a\u8179<\/span><\/p>\n<\/td>\n

      		\n

      28<\/span><\/p>\n<\/td>\n

      		\n

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

      \uff08\u542b\u4e73\u7cd6\uff09<\/span><\/p>\n<\/td>\n

      		\n

      0.72h\u00b10.63<\/span><\/p>\n<\/td>\n

      		\n

      \u7b49\u6548<\/span><\/p>\n<\/td>\n

      		\n

      \u53d7\u8bd5\u5236\u5242\u4e0d\u542b\u4e73\u7cd6<\/span><\/p>\n<\/td>\n<\/tr>\n

      \n

      2015<\/span><\/p>\n<\/td>\n

      		\n

      \u82f1\u56fd[23]<\/sup><\/span><\/p>\n<\/td>\n

      		\n

      2*2 \u7a7a\u8179<\/span><\/p>\n<\/td>\n

      		\n

      24<\/span><\/p>\n<\/td>\n

      		\n

      Riemser Arzneimittel<\/span><\/p>\n

      \uff08\u4e0d\u542b\u4e73\u7cd6\uff09<\/span><\/p>\n<\/td>\n


      <\/td>\n      		\n

      \u7b49\u6548\uff0cIntra cv 17.61%<\/span><\/p>\n<\/td>\n

      		\n

      \u53d7\u8bd5\u5236\u5242\u4e0d\u542b\u4e73\u7cd6<\/span><\/p>\n<\/td>\n<\/tr>\n

      \n

      2008<\/span><\/p>\n<\/td>\n

      		\n

      \u5df4\u897f[24]<\/sup><\/span><\/p>\n<\/td>\n

      		\n

      2*2 \u7a7a\u8179<\/span><\/p>\n<\/td>\n

      		\n

      28<\/span><\/p>\n<\/td>\n


      <\/td>\n
      <\/td>\n
      <\/td>\n
      <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

       <\/span><\/p>\n

      \u4e09\u3001BE\u8c41\u514d\u5bf9\u4e8e\u4f53\u5185\u7b49\u6548\u7684\u98ce\u9669\u56e0\u7d20<\/span><\/strong><\/p>\n

      \u867d\u7136\u5f02\u70df\u80bc\u53ef\u4ee5\u901a\u8fc7\u81ea\u8bc1BCS\u5206\u7c7b\uff0c\u91c7\u7528\u836f\u5b66\u65b9\u6cd5\u8bc4\u4ef7\u4e00\u81f4\u6027\u6765\u8c41\u514d\u4f53\u5185BE\uff0c\u4f46\u56e0\u5f02\u70df\u80bc\u5f71\u54cd\u56e0\u7d20\u8f83\u591a\uff0c\u5982\u98df\u7269\u5f71\u54cd\u3001\u5408\u5e76\u7528\u836f\u3001\u7279\u6b8a\u9002\u5e94\u4eba\u7fa4\u7b49\u7279\u70b9\uff0c\u82e5\u9519\u8bef\u6279\u51c6\u8c41\u514d\u4f53\u5185BE\uff0c\u5c06\u4f1a\u5bf9\u516c\u5171\u536b\u751f\u548c\u4e2a\u4f53\u60a3\u8005\u7684\u5b89\u5168\u6027\u548c\u7597\u6548\u6027\u4ea7\u751f\u4e0d\u826f\u540e\u679c[23]<\/sup>\u3002<\/span><\/p>\n

      \uff081\uff09   <\/span><\/span><\/strong>\u98df\u7269\u5f71\u54cd\u56e0\u7d20\uff1a<\/span><\/strong><\/p>\n

      \u6839\u636e\u539f\u7814\u8bf4\u660e\u4e66[21]<\/sup>\u53ef\u77e5\uff0c\u98df\u7269\u663e\u8457\u5f71\u54cd\u5f02\u70df\u80bc\u7684\u751f\u7269\u5229\u7528\u5ea6\uff0c\u751f\u7269\u5229\u7528\u5ea6\u7684\u5f71\u54cd\u76f4\u63a5\u5173\u7cfb\u5230\u5176\u6e17\u900f\u6027\u5927\u5c0f\uff0c\u5f71\u54cd\u836f\u7269\u7684\u5438\u6536\uff0c\u56e0\u6b64\uff0c\u4e5f\u9700\u8bc4\u4f30\u5176\u5bf9BE\u8c41\u514d\u7684\u98ce\u9669\u7684\u5f71\u54cd\u3002<\/span><\/p>\n

      \uff082\uff09   <\/span><\/span><\/strong>\u9002\u5e94\u4eba\u7fa4\uff1a<\/span><\/strong><\/p>\n

      \u5f02\u70df\u80bc\u9002\u7528\u4eba\u7fa4\u5305\u62ec\u4e86\u513f\u7ae5[21]<\/sup>\uff0c\u9700\u7279\u522b\u8003\u8651\u751f\u7269\u4e0d\u7b49\u6548\u98ce\u9669\u5bf9\u60a3\u8005\u5b89\u5168\u6027\u548c\u7597\u6548\u7684\u5f71\u54cd\u3002<\/span><\/p>\n

      \uff083\uff09   <\/span><\/span><\/strong>\u6bd2\u6027<\/span><\/strong><\/p>\n

      \u5f02\u70df\u80bc\u6cbb\u7597\u6700\u5e38\u89c1\u7684\u526f\u4f5c\u7528\u662f\u809d\u6bd2\u6027\u3001\u5468\u56f4\u795e\u7ecf\u75c5\u53d8[21]<\/sup>\uff0c\u636e\u62a5\u9053\uff0c\u4e25\u91cd\u7684\u6bd2\u6027\u75c7\u72b6\u5728\u6210\u4eba2-3g\u6216\u66f4\u9ad8\u7684\u5242\u91cf\u4e0b\u53d1\u751f\uff0c\u6ca1\u6709\u9002\u5f53\u6cbb\u7597\u7684\u60c5\u51b5\u4e0b\uff0c10-15\u514b\u7684\u5242\u91cf\u53ef\u80fd\u662f\u81f4\u547d\u7684\uff0c\u56e0\u6b64\uff0c\u53ef\u770b\u51fa\u4e0d\u826f\u53cd\u5e94\u5448\u5242\u91cf\u5173\u7cfb[7]<\/sup>\u3002<\/span><\/p>\n

      \uff084\uff09   <\/span><\/span><\/strong>\u5408\u5e76\u7528\u836f<\/span><\/strong><\/p>\n

      \u5f02\u70df\u80bc\u4e0e\u591a\u79cd\u836f\u7269\u5b58\u5728\u76f8\u4e92\u4f5c\u7528\uff0c\u5982\u5bf9\u4e59\u9170\u6c28\u57fa\u915a\u3001\u5361\u9a6c\u897f\u5e73\u3001\u916e\u5eb7\u5511\u3001\u82ef\u59a5\u82f1\u94a0\u3001\u8336\u78b1\u3001\u4e19\u620a\u9178\u94a0\u3001\u6297\u51dd\u836f\u7b49\uff0c\u4f1a\u589e\u52a0\u4e0d\u826f\u53cd\u5e94\uff0c\u964d\u4f4e\u7597\u6548[21]<\/sup>\u3002\u7279\u522b\u662f\u8003\u8651\u5f02\u70df\u80bc\u901a\u5e38\u548c\u5229\u798f\u5e73\u3001\u5421\u55ea\u9170\u80fa\u3001\u4e59\u80fa\u4e01\u9187\u7b49\u591a\u79cd\u836f\u7269\u8054\u5408\u4f7f\u7528\uff0c\u5b89\u5168\u6027\u7684\u98ce\u9669\u4e5f\u4f1a\u76f8\u5e94\u7684\u589e\u5927\uff0c\u8c41\u514dBE\u65f6\u4e5f\u5e94\u8003\u8651\u3002<\/span><\/p>\n

       <\/span><\/p>\n

      4<\/span><\/strong>\u3001\u56fd\u5185\u5f02\u70df\u80bc\u6ce8\u518c\u73b0\u72b6<\/span><\/strong><\/p>\n

      \u4ece\u6ce8\u518c\u4e8e\u53d7\u7406\u6570\u636e\u5e93\u4e2d\u53ef\u77e5\uff0c\u76ee\u524d\u56fd\u5185\u67094\u5bb6\u4f01\u4e1a\u5df2\u9012\u4ea4\u4e86\u8865\u5145\u7533\u8bf7\uff0c\u6b63\u5728\u5ba1\u8bc4\u5ba1\u6279\u4e2d\uff0c\u4f46\u5728\u4e34\u5e8a\u8bd5\u9a8c\u767b\u8bb0\u5e73\u53f0\u4e0a\u672a\u67e5\u5230BE\u8bd5\u9a8c\uff0c\u63a8\u6d4b\u4ed6\u4eec\u91c7\u53d6\u7684\u662fBE\u8c41\u514d\u7684\u65b9\u5f0f\uff08\u5305\u62ec\u53d8\u66f4\/\u4e0d\u53d8\u66f4\u5904\u65b9\u5de5\u827a\uff09\u8fdb\u884c\u7684\u7533\u62a5\u751f\u4ea7\u3002\u800c\u636e\u4e86\u89e3\u6709\u836f\u4f01\u4ecd\u5728\u8fdb\u884cBE\u8bd5\u9a8c\uff0c\u4f7f\u7528\u7684\u53c2\u6bd4\u5236\u5242\u4e3a\u7b2c\u5341\u56db\u6279\u63a8\u8350\u7684Teva\u516c\u53f8\u7684\u5f02\u70df\u80bc\uff0c\u53ef\u80fd\u8be5\u4f01\u4e1a\u8ba4\u4e3a\u5176\u54c1\u79cdBE\u8c41\u514d\u5145\u5206\u6027\u4e0d\u8db3\uff08\u5982\u4e0a\u6240\u8ff0\uff0c\u7684\u786e\u662f\u6709\u4e0d\u591f\u5145\u5206\u7684\u5730\u65b9\uff09\uff0cBE\u8c41\u514d\u5b58\u5728\u4e00\u5b9a\u98ce\u9669\uff0c\u56e0\u6b64\u8fdb\u884c\u4f53\u5185BE\u8bd5\u9a8c\u3002<\/span><\/p>\n

       <\/span><\/p>\n

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      \u5f53\u6ee1\u8db3NMPA\u8981\u6c42\u7684BE\u8c41\u514d\u6761\u4ef6\u540e\uff0c\u4f01\u4e1a\u4f9d\u65e7\u9700\u8981\u8003\u8651\u5230\u5f02\u70df\u80bcBE\u7684\u591a\u4e2a\u5f71\u54cd\u56e0\u7d20\uff0c\u5982\u5408\u5e76\u7528\u836f\u3001\u9910\u540e\u5f71\u54cd\u3001\u4e0d\u826f\u53cd\u5e94\u3001\u9002\u7528\u4eba\u7fa4\u7b49\u3002\u8fd9\u4e9b\u4e0d\u786e\u5b9a\u7684\u5f71\u54cd\u56e0\u7d20\u7684\u5b58\u5728\u5747\u6709\u53ef\u80fd\u5bf9\u4f53\u5185\u771f\u6b63\u6cbb\u7597\u7b49\u6548\u5b58\u5728\u4e00\u5b9a\u98ce\u9669\u3002<\/span><\/p>\n

      \u56e0\u6b64\uff0c\u5bf9\u4e8e\u8fd8\u5728\u5f00\u5c55\u4f53\u5185BE\u8bd5\u9a8c\u5bf9\u4e8e\u4f01\u4e1a\u6765\u8bf4\uff0c\u867d\u7136\u5b58\u5728\u5468\u671f\u957f\u3001\u8d39\u7528\u9ad8\u7684\u95ee\u9898\uff0c\u4f46\u4f53\u5185BE\u662f\u8bc4\u4ef7\u836f\u7269\u5236\u5242\u4e00\u81f4\u6027\u7684\u201c\u91d1\u6807\u51c6\u201d\uff0c\u80fd\u4fdd\u8bc1\u60a3\u8005\u7528\u836f\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\uff0c\u964d\u4f4e\u836f\u7269\u7684\u6ce8\u518c\u548c\u4e0a\u5e02\u98ce\u9669\uff0c\u73b0\u9636\u6bb5\u4e5f\u65e0\u6cd5\u8d76\u4e0a\u524d\u9762\u51e0\u5bb6\u8c41\u514dBE\u7684\u8fdb\u5ea6\uff0c\u5931\u53bb\u4e86\u901a\u8fc7\u4e00\u81f4\u6027\u8bc4\u4ef7\u7684\u5148\u673a\uff0c\u4f46\u662f\u672a\u6765\u5e02\u573a\u6709\u4eba\u4f53\u6570\u636e\u7684\u603b\u8981\u5360\u6709\u4e00\u5b9a\u7684\u4f18\u52bf\uff0c\u6bd4\u5982\u5728\u539f\u7814\u672a\u6709\u8fdb\u5165\u4e2d\u56fd\u5e02\u573a\u65f6\uff0c\u662f\u5426\u53ef\u4ee5\u628a\u56fd\u5185\u7684\u9ad8\u6807\u51c6\u7ecf\u8fc7\u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027\u7684\u53d7\u8bd5\u5236\u5242\u5217\u4e3a\u53c2\u6bd4\u5462\uff1f\u672a\u5c1d\u4e0d\u53ef\u3002\u6211\u4eec\u8fd9\u4e2a\u884c\u4e1a\u9700\u8981\u811a\u8e0f\u5b9e\u5730\u7684\u4f01\u4e1a\uff0c\u5728\u904d\u5730\u201c\u4ef0\u671b\u5929\u7a7a\u201d\u3001\u201c\u653f\u7b56\u6295\u673a\u201d\u7684\u6d2a\u6d41\u4e2d\u771f\u7684\u66f4\u9700\u8981\u3002\u5236\u836f\u4f01\u4e1a\u7684\u826f\u5fc3\u8d77\u4e8e\u811a\u8e0f\u5b9e\u5730\u7684\u7814\u7a76\uff01\u90a3\u6211\u4eec\u7684\u653f\u7b56\u5f15\u5bfc\u4e5f\u4e0d\u80fd\u8ba9\u8001\u5b9e\u7684\u4eba\u603b\u5403\u4e8f\u3002<\/span><\/p>\n

       <\/span><\/p>\n

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

      [1] 289\u57fa\u836f\u76ee\u5f55\u4e2d\u53ef\u8c41\u514d\u6216\u7b80\u5316\u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c(BE)\u54c1\u79cd\u540d\u5355\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09, 2017.<\/span><\/p>\n

      [2] \u53ef\u8c41\u514d\u6216\u7b80\u5316\u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027\uff08BE\uff09\u8bd5\u9a8c\u54c1\u79cd, 2018.<\/span><\/p>\n

      [3] Proposal to waivein vivo bioequivalence requirements For the who model list of essentialmedicines Immediate release, solid oral dosage forms, WHO, 2005.<\/span><\/p>\n

      [4] Intra-AgencyAgreement Between the Eunice Kennedy Shriver National Institute of Child Healthand Human Development (NICHD) and the U.S. Food and Drug Administration (FDA)[J].2011.<\/span><\/p>\n

      [5] Maejima T, Kubo M,Osawa T, et al. Application of tumbling melt granulation (TMG) method toprepare controlled-release fine granules[J]. Chemical & PharmaceuticalBulletin, 1998, 46(3): 534.<\/span><\/p>\n

      [6] Brewer GA.Analytical profiles of drug substances and excipients[J], Florey\u2019s K, BrittainHG. London: Academic Press, Inc.; 1977. pp 184\u2013258.<\/span><\/p>\n

      [7] Becker C, Dressman,JB, Amidon GL, et al. Biowaiver Monographs for Immediate Release Solid<\/span><\/p>\n

      Oral Dosage Forms:Isoniazid[J]. J Pharm Sci, 2012, 101(1): 10-6.<\/span><\/p>\n

      [8] \u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u8c41\u514d\u6307\u5bfc\u539f\u5219[J], 201605.<\/span><\/p>\n

      [9] Mariappan TT, SinghS. Regional gastrointestinal permeability of rifampicin and isoniazid(alone andtheir combination) in the rat[J]. Int J, Tuberc Lung, 2003, 7: 797\u2013803.<\/span><\/p>\n

      [10] Kakemi K, AritaT, Sezaki H, et al. Absorption and excretion of drugs. XXII. Absorption<\/span><\/p>\n

      of isoniazid and itsderivatives (1). Chem Pharm Bull (Tokyo), 1965, 13: 551\u2013557.<\/span><\/p>\n

      [11] Kleber FX. Absorptionof anti-tuberculous drugs after gastric surgery (author\u2019s transl)[J]. Prax KlinPneumol, 1979, 33:38\u201344.<\/span><\/p>\n

      [12] Polk RE, TenenbaumM, Kline B. Isoniazid and ethambutol absorption with jejunoileal bypass[J]. AnnIntern Med, 1978, 89: 430\u2013431.<\/span><\/p>\n

      [13] Elmendorf DF,Cawthon WU, Muschenheim C, et al. The absorption, distribution, excretion, andshort-term toxicity of isonicotinic acid hydrazide (nydrazid) in man[J]. Am RevTuberc, 1952, 65: 429\u2013442.<\/span><\/p>\n

      [14] Kasim NA,Whitehouse M, Ramachandran C, et a. 2004. Molecular properties of WHO essentialdrugs and provisional biopharmaceutical classification[J]. Mol Pharm, 2004, 85\u201396.<\/span><\/p>\n

      [15] Kakemi K, AritaT, Sezaki H, et al. Absorption and excretion of drugs. XXII. Absorption ofisoniazid and its derivatives[J]. Chem Pharm Bull (Tokyo), 1965, 13: 551\u2013557.<\/span><\/p>\n

      [16] Rao KV, KailasamS, Menon NK, et al. 1971. Inactivation of isoniazid by condensation in a<\/span><\/p>\n

      syrup preparation[J].Indian J Med Res 59: 1343\u20131353.<\/span><\/p>\n

      [17] Sved S,McGilveray IJ, Beaudoin N. Bioavailability of three isoniazid formulations. JPharm Sci, 1977, 66: 1761\u20131764.<\/span><\/p>\n

      [18] \u4eff\u5236\u836f\u53c2\u6bd4\u5236\u5242\u76ee\u5f55\uff08\u7b2c\u4e94\u6279\uff09, 2017.<\/span><\/p>\n

      [19] Sandoz\u516c\u53f8\u5f02\u70df\u80bc\u7247\u8bf4\u660e\u4e66.<\/span><\/p>\n

      [20] \u4eff\u5236\u836f\u53c2\u6bd4\u5236\u5242\u76ee\u5f55\uff08\u7b2c\u5341\u56db\u6279\uff09, 2018.<\/span><\/p>\n

      [21] Teva\u516c\u53f8\u5f02\u70df\u80bc\u7247\u8bf4\u660e\u4e66.<\/span><\/p>\n

      [22] Isoniazid 100 mgTablets (Mylan Laboratories Limited), India, \u5ba1\u8bc4\u62a5\u544a,2016.<\/span><\/p>\n

      [23] Isoniazid 100 mgTablets (Morningside Healthcare Limited), HMRA, \u5ba1\u8bc4\u62a5\u544a,2015.<\/span><\/p>\n

      [24] A BioequivalenceStudy of Two Different Dosages of Isoniazid Tablet Formulations in Human HealthyVolunteers, Clinical trial, 2014.<\/span><\/p>\n

      [25] \u5ed6 \u840d\uff0c\u5f20\u666f\u8fb0*\uff0c\u9646 \u5cf0, \u57fa\u4e8eBCS \u7684\u666e\u901a\u53e3\u670d\u56fa\u4f53\u5e38\u91ca\u5236\u5242\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u8c41\u514d\u7684<\/span>\u91cf\u5316\u98ce\u9669\u8bc4\u4f30[J]. \u4e2d\u56fd\u533b\u836f\u5de5\u4e1a\u6742\u5fd7, 2018, 49(1): 29-37.<\/span><\/p>\n

      \"\u5f02\u70df\u80bc\u7247\u7b49\u751f\u7269\u7b49\u6548\u6027\u8c41\u514d\uff0c\u673a\u9047
      <\/p>\n

      \n

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      <\/p>\n

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      <\/p>\n

      \n

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      <\/p>\n


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

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

      \u2014\u2014\u2014\u2014<\/span><\/p>\n

      \n


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