{"id":74663,"date":"2019-01-14T00:00:50","date_gmt":"2019-02-01T05:35:49","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/74663\/"},"modified":"2019-02-01T13:35:50","modified_gmt":"2019-02-01T05:35:50","slug":"274658308d","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/74663\/","title":{"rendered":"CDE | \u516c\u5f00\u5f81\u6c42\u300a\u5173\u4e8e\u5728\u539f\u6599\u836f\u5de5\u827a\u4e2d\u751f\u6210\u4e9a\u785d\u80fa\u7c7b\u5316\u5408\u7269\u7684\u98ce\u9669\u8b66\u793a\u300b\u610f\u89c1\u7684\u901a\u77e5"},"content":{"rendered":"<div class=\"bpp-post-content\">\n<p><img class=\"\"      style=\"\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/02\/10-1548999350.jpg\" alt=\"CDE | \u516c\u5f00\u5f81\u6c42\u300a\u5173\u4e8e\u5728\u539f\u6599\u836f\u5de5\u827a\u4e2d\u751f\u6210\u4e9a\u785d\u80fa\u7c7b\u5316\u5408\u7269\u7684\u98ce\u9669\u8b66\u793a\u300b\u610f\u89c1\u7684\u901a\u77e5\" title=\"CDE | 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14px;\">\u8fd1\u671f\uff0c\u5728\u5df2\u4e0a\u5e02\u7684\u7f2c\u6c99\u5766\u539f\u6599\u836f\u4e2d\u53d1\u73b0\u5b58\u5728\u68c0\u51fa\u5fae\u91cf\u7684N-\u4e9a\u785d\u57fa\u4e8c\u7532\u80fa(NDMA)\u548cN-\u4e9a\u785d\u57fa\u4e8c\u4e59\u80fa(NDEA) \u6742\u8d28\u7684\u98ce\u9669\u3002\u6839\u636e\u4e16\u754c\u536b\u751f\u7ec4\u7ec7\u56fd\u9645\u764c\u75c7\u7814\u7a76\u673a\u6784\u81f4\u764c\u7269\u6e05\u5355\uff0cNDMA\u548cNDEA\u5747\u5c5e\u4e8e2A\u7c7b\u81f4\u764c\u7269\u8d28\uff0c\u5373\u5bf9\u4eba\u7c7b\u81f4\u764c\u6027\u8bc1\u636e\u6709\u9650\uff0c\u4f46\u5bf9\u5b9e\u9a8c\u52a8\u7269\u81f4\u764c\u6027\u8bc1\u636e\u5145\u5206\u7684\u7269\u8d28\u3002\u540c\u65f6\uff0c\u4e9a\u785d\u80fa\u7c7b\u5316\u5408\u7269\u5c5e\u4e8eICH 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14px;\">\u7ed3\u5408\u6587\u732e\u8c03\u7814\u548c\u53cd\u5e94\u673a\u7406\u5206\u6790\uff0c\u80fa\u7c7b\u5316\u5408\u7269\uff0c\u5c24\u5176\u662f\u4ef2\u80fa\u7c7b\u5316\u5408\u7269\u4e0e\u4e9a\u785d\u9178\u76d0\u5728\u9178\u6027\u73af\u5883\u4e2d\u53ef\u751f\u6210\u4e9a\u785d\u80fa\u7c7b\u5316\u5408\u7269[1]\uff0c\u5982\u4e0b\u6240\u793a\uff1a<\/span><\/p>\n<p><img class=\"\"      style=\"box-sizing: border-box !important;word-wrap: break-word !important;width: 355px !important;visibility: visible !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/02\/6-1548999350.png\" alt=\"CDE | \u516c\u5f00\u5f81\u6c42\u300a\u5173\u4e8e\u5728\u539f\u6599\u836f\u5de5\u827a\u4e2d\u751f\u6210\u4e9a\u785d\u80fa\u7c7b\u5316\u5408\u7269\u7684\u98ce\u9669\u8b66\u793a\u300b\u610f\u89c1\u7684\u901a\u77e5\" title=\"CDE | 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14px;\">l&nbsp;\u5982\u53cd\u5e94\u4e2d\u6709\u80fa\u7c7b\u5316\u5408\u7269\u4e0e\u4e9a\u785d\u9178\u76d0\u4e24\u8005\u540c\u65f6\u5b58\u5728\u7684\u60c5\u51b5\uff0c\u5e94\u7279\u522b\u5173\u6ce8\u53ef\u80fd\u751f\u6210\u7684\u76f8\u5173\u4e9a\u785d\u80fa\u7c7b\u5316\u5408\u7269\u3002<\/span><\/p>\n<p><span style=\"font-size: 14px;\"><br  \/><\/span><\/p>\n<p><span style=\"font-size: 14px;\">l&nbsp;\u5982\u4f7f\u7528\u7684\u53cd\u5e94\u7269\u6599\u4e2d\u5b58\u5728\u80fa\u7c7b\u5316\u5408\u7269\u6b8b\u7559\uff0c\u6216\u5206\u89e3\u751f\u6210\u80fa\u7c7b\u5316\u5408\u7269\u7684\u6f5c\u5728\u53ef\u80fd\uff0c\u540e\u7eed\u518d\u4f7f\u7528\u4e9a\u785d\u9178\u76d0\u53cd\u5e94\u6216\u5904\u7406\u53cd\u5e94\u65f6\uff0c\u4e5f\u5e94\u7279\u522b\u5173\u6ce8\u53ef\u80fd\u751f\u6210\u7684\u76f8\u5173\u4e9a\u785d\u80fa\u7c7b\u5316\u5408\u7269\u3002<\/span><\/p>\n<p><span style=\"font-size: 14px;\"><br  \/><\/span><\/p>\n<p><strong><span style=\"font-size: 14px;\">\u4e09\u3001\u4e9a\u785d\u80fa\u7c7b\u5316\u5408\u7269\u7684\u98ce\u9669\u63a7\u5236\u7b56\u7565<\/span><\/strong><\/p>\n<p><span style=\"font-size: 14px;\"><br  \/><\/span><\/p>\n<p><span style=\"font-size: 14px;\">\u4e9a\u785d\u80fa\u7c7b\u5316\u5408\u7269\u5c5e\u4e8eICH M7\u6307\u5357\u63d0\u793a\u7684\u5177\u6709\u8f83\u9ad8\u81f4\u764c\u6027\uff08\u201c\u5173\u6ce8\u961f\u5217\u201d\uff09\u7684\u4e00\u7c7b\u5316\u5408\u7269\uff0c\u7531\u4e8e\u5176\u5728\u6781\u4f4e\u66b4\u9732\u91cf\u4e0b\u5373\u53ef\u81f4\u764c\uff0c\u63a7\u5236\u9650\u5ea6\u8fdc\u4f4e\u4e8e\u4e00\u822c\u7684\u6742\u8d28\uff0c\u91c7\u7528\u5e38\u89c4\u7684\u6709\u5173\u7269\u8d28\u68c0\u67e5\u65b9\u6cd5\u901a\u5e38\u96be\u4ee5\u6709\u6548\u7684\u63a7\u5236\u6b64\u7c7b\u6742\u8d28\u3002\u56e0\u6b64\u7814\u7a76\u548c\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u5e94\u53c2\u8003ICH M7\u6307\u5357\u7684\u76f8\u5173\u8981\u6c42[2]\uff0c\u4ece\u5de5\u827a\u5206\u6790\u3001\u6742\u8d28\u63a7\u5236\u548c\u6e05\u9664\u7b56\u7565\u3001\u8d28\u91cf\u7814\u7a76\u4ee5\u53ca\u6742\u8d28\u9650\u5ea6\u5236\u5b9a\u7b49\u5404\u65b9\u9762\uff0c\u6574\u4f53\u63a7\u5236\u539f\u6599\u836f\u548c\u5236\u5242\u4e2d\u4e0e\u4e9a\u785d\u80fa\u7c7b\u5316\u5408\u7269\u76f8\u5173\u7684\u98ce\u9669\u3002<\/span><\/p>\n<p><span style=\"font-size: 14px;\"><br  \/><\/span><\/p>\n<p><span style=\"font-size: 14px;\">\u5982\u62df\u8fdb\u884c\u5f00\u53d1\u6216\u7814\u7a76\u5f00\u53d1\u4e2d\u7684\u539f\u6599\u836f\u5de5\u827a\u5b58\u5728\u751f\u6210\u4e9a\u785d\u80fa\u7c7b\u5316\u5408\u7269\u7684\u98ce\u9669\uff0c\u5982\u672c\u6587\u7b2c\u4e8c\u6761\u6240\u8ff0\u60c5\u51b5\uff0c\u836f\u54c1\u7814\u53d1\u548c\u751f\u4ea7\u4f01\u4e1a\u5e94\u9996\u5148\u5206\u6790\u4e9a\u785d\u9178\u76d0\uff0c\u4ee5\u53ca\u53ef\u80fd\u5f62\u6210\u4e9a\u785d\u80fa\u7c7b\u6742\u8d28\u7684\u76f8\u5173\u8bd5\u5242\u548c\u6eb6\u5242\u5728\u5de5\u827a\u4e2d\u4f7f\u7528\u7684\u5fc5\u8981\u6027\uff0c\u5c3d\u91cf\u907f\u514d\u9009\u62e9\u53ef\u80fd\u751f\u6210\u4e9a\u785d\u9178\u80fa\u7c7b\u5316\u5408\u7269\u7684\u751f\u4ea7\u5de5\u827a&nbsp;[3]\u3002\u82e5\u5fc5\u987b\u4f7f\u7528\u65f6\uff0c\u5219\u987b\u6839\u636e\u5de5\u827a\u8def\u7ebf\u5206\u6790\u540e\u7eed\u53ef\u80fd\u751f\u6210\u7684\u4e9a\u785d\u80fa\u7c7b\u5316\u5408\u7269\u7ed3\u6784\uff0c\u5e76\u4f18\u5316\u5de5\u827a\uff0c\u589e\u52a0\u9002\u5b9c\u7684\u6742\u8d28\u6e05\u9664\u6b65\u9aa4\uff0c\u5236\u5b9a\u8be6\u7ec6\u7684\u8fc7\u7a0b\u63a7\u5236\u7b56\u7565\uff0c\u4fdd\u8bc1\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u6b64\u7c7b\u6742\u8d28\u7684\u6709\u6548\u53bb\u9664\u3002<\/span><\/p>\n<p><span style=\"font-size: 14px;\"><br  \/><\/span><\/p>\n<p><span style=\"font-size: 14px;\">\u5bf9\u4e8e\u5df2\u4e0a\u5e02\u7684\u539f\u6599\u836f\uff0c\u539f\u6599\u836f\u751f\u4ea7\u4f01\u4e1a\u4e5f\u5e94\u8be5\u4fdd\u6301\u5bf9\u4ea7\u54c1\u8d28\u91cf\u7684\u6301\u7eed\u5173\u6ce8\uff0c\u5982\u53d1\u73b0\u73b0\u884c\u751f\u4ea7\u5de5\u827a\u4e2d\u5b58\u5728\u751f\u6210\u4e9a\u785d\u80fa\u7c7b\u5316\u5408\u7269\u7684\u98ce\u9669\uff0c\u5e94\u53ca\u65f6\u5c55\u5f00\u76f8\u5173\u7814\u7a76\uff0c\u91cd\u65b0\u8bc4\u4f30\u5de5\u827a\u7684\u5408\u7406\u6027\uff0c\u5236\u5b9a\u76f8\u5173\u7684\u63a7\u5236\u7b56\u7565\u548c\u6807\u51c6\uff0c\u8fdb\u884c\u8865\u5145\u7814\u7a76\uff0c\u5de5\u827a\u548c\u8d28\u91cf\u6807\u51c6\u53d8\u66f4\u7b49\u5185\u5bb9\u9700\u6309\u7167\u76f8\u5173\u8981\u6c42\u63d0\u4ea4\u81f3\u836f\u54c1\u76d1\u7ba1\u90e8\u95e8\u3002<\/span><\/p>\n<p><span style=\"font-size: 14px;\"><br  \/><\/span><\/p>\n<p><span style=\"font-size: 14px;\">\u5e94\u9009\u62e9\u5177\u6709\u8f83\u9ad8\u7075\u654f\u5ea6\u7684\u6d4b\u8bd5\u65b9\u6cd5\uff08\u5982GC-MS\u3001HPLC-MS\u7b49\uff09\u5bf9\u4e0a\u8ff0\u5de5\u827a\u8def\u7ebf\u5206\u6790\u5f97\u5230\u7684\u4e9a\u785d\u80fa\u7c7b\u5316\u5408\u7269\u8fdb\u884c\u68c0\u6d4b\u548c\u63a7\u5236\uff0c\u5e76\u91c7\u7528\u6742\u8d28\u5bf9\u7167\u54c1\u8fdb\u884c\u5b8c\u6574\u7684\u65b9\u6cd5\u5b66\u9a8c\u8bc1\uff0c\u5982\u7cfb\u7edf\u9002\u7528\u6027\u3001\u4e13\u5c5e\u6027\u3001\u7075\u654f\u5ea6\u548c\u51c6\u786e\u5ea6\u7b49\uff0c\u4fdd\u8bc1\u4e9a\u785d\u80fa\u7c7b\u5316\u5408\u7269\u80fd\u591f\u51c6\u786e\u6709\u6548\u7684\u68c0\u51fa\u3002<\/span><\/p>\n<p><span style=\"font-size: 14px;\"><br  \/><\/span><\/p>\n<p><span style=\"font-size: 14px;\">\u539f\u6599\u836f\u4e2d\u4e9a\u785d\u80fa\u7c7b\u5316\u5408\u7269\u7684\u63a7\u5236\u7b56\u7565\u5efa\u8bae\u53c2\u8003ICH M7\u6307\u5357\u7684\u76f8\u5173\u89c4\u5b9a\uff0c\u7ed3\u5408\u6b64\u7c7b\u6742\u8d28\u7684\u5b89\u5168\u6027\u6570\u636e\u3001\u5236\u5242\u7684\u7528\u6cd5\u7528\u91cf\u7b49\u60c5\u51b5\u7efc\u5408\u786e\u5b9a\u3002\u5e94\u4fdd\u8bc1\u6700\u7ec8\u62df\u5b9a\u7684\u63a7\u5236\u7b56\u7565\u548c\u6742\u8d28\u9650\u5ea6\u5177\u6709\u5145\u5206\u5408\u7406\u7684\u79d1\u5b66\u4f9d\u636e\u3002\u8bf7\u6ce8\u610f\u672c\u7c7b\u6742\u8d28\u81f4\u764c\u98ce\u9669\u8f83\u9ad8\uff0c\u4ec5\u4ec5\u6309\u7167ICH M7\u63d0\u51fa\u7684\u6bd2\u7406\u5b66\u5173\u6ce8\u9608\uff08TTC\uff09\u5373\u65e5\u66b4\u9732\u91cf1.5\u03bcg\/\u5929\u5c1a\u4e0d\u8db3\u4ee5\u5145\u5206\u63a7\u5236\u98ce\u9669\uff0c\u5177\u4f53\u9650\u5ea6\u7684\u786e\u5b9a\u53ef\u53c2\u8003\u672c\u6587\u6240\u9644\u793a\u4f8b\u3002<\/span><\/p>\n<p><span style=\"font-size: 14px;\"><br  \/><\/span><\/p>\n<p><span style=\"font-size: 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14px;\">\u4e00\u822c\u6765\u8bf4\uff0c\u5bf9\u4e8e\u5177\u6709\u9633\u6027\u81f4\u764c\u6570\u636e\u7684\u8bf1\u53d8\u6742\u8d28\uff0c\u5efa\u8bae\u6839\u636eCPDB\uff08Carcinogenicity Potency Database\uff09\u6570\u636e\u5e93\u4e2d\u81f4\u764c\u6027\u7269\u8d28\u7684TD50\u503c\u6765\u8ba1\u7b97\u6bcf\u65e5\u53ef\u63a5\u53d7\u7684\u6444\u5165\u91cf\uff08AI\uff09\u3002NDMA\u5728\u5c0f\u9f20\u4e0e\u5927\u9f20\u7684TD50\u503c\u5206\u522b\u4e3a0.189mg\/kg\/\u5929\u548c0.0959mg\/kg\/\u5929\u3002\u6309\u7167\u66f4\u4e3a\u4fdd\u5b88\u7684\u5927\u9f20TD50\u503c0.0959mg\/kg\/\u5929\u548c\u4eba\u4f53\u91cd50kg\u6765\u8ba1\u7b97\u4eba\u6bcf\u65e5\u6700\u5927\u6444\u5165\u91cf\u4e3a\uff1a0.0959mg\/kg\/\u5929\u00d750kg\/50000=0.0000959mg\/\u5929\u22480.1\u03bcg\/\u5929\uff0c\u6b64\u65f6\u5bf9\u5e94\u80bf\u7624\u53d1\u751f\u98ce\u9669\u4e3a\u767e\u4e07\u5206\u4e4b\u4e00\u3002<\/span><\/p>\n<p><span style=\"font-size: 14px;\"><br  \/><\/span><\/p>\n<p><span style=\"font-size: 14px;\">\u7f2c\u6c99\u5766\u539f\u6599\u4e2d\u7684\u5177\u4f53\u6742\u8d28\u9650\u91cf\u6807\u51c6\u53ef\u6839\u636e\u6bcf\u65e5\u7528\u836f\u91cf\u548c\u7528\u836f\u5468\u671f\u8fdb\u884c\u8c03\u6574\u3002\u82e5\u6309\u7167\u6bcf\u65e5\u7528\u836f320mg\u8ba1\u7b97\uff0c\u5373\u5c06NDMA\u9650\u91cf\u8bbe\u5b9a\u4e3a0.1\u03bcg \/320mg=0.00003%=0.3PPM\u3002<\/span><\/p>\n<p><span style=\"font-size: 14px;\"><br  \/><\/span><\/p>\n<p><span style=\"font-size: 14px;\">\u53c2\u8003\u6587\u732e\uff1a<\/span><\/p>\n<p><span style=\"font-size: 12px;\">1\u3001(a) A Screening Procedure for the Formation of Nitroso Derivatives and Mutagens by Drug-Nitrite Interaction, Chem Pharm Bull, 1982, 30(9), 3399-3404. (b) Formation of N-Nitrosodimethylamine (NDMA) from Dimethylamine during Chlorination, Environ. Sci. Technol., 2002, 36 (4), 588-595. (c) Organic Synth., 2, 460 (1943). (d) Organic Synth., 15, 48 (1935).<\/span><\/p>\n<p><span style=\"font-size: 12px;\">2\u3001ICH. M7(R1) &nbsp;Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals of limit potential carcinogenic risk [EB\/OL\uff3d.(2017-03-31)<\/span><\/p>\n<p><span style=\"font-size: 12px;\">3\u3001Inhibition of Nitrosamine Formation by Inorganic and Organic Salts, Chem Pharm Bull, 1986, 34(8), 3485-3487.<\/span><\/p>\n<p style=\"text-align: center;\">\n<p><br  \/><\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u9644\u4ef6\uff1a\u5173\u4e8e\u5728\u539f\u6599\u836f\u5de5\u827a\u4e2d\u751f\u6210\u4e9a\u785d\u80fa\u7c7b\u5316\u5408\u7269\u7684\u98ce\u9669\u8b66\u793a &nbsp;\u4e00\u3001\u80cc\u666f \u8fd1\u671f\uff0c\u5728\u5df2\u4e0a\u5e02\u7684\u7f2c\u6c99\u5766\u539f\u6599\u836f\u4e2d\u53d1\u73b0 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":74664,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/74663"}],"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=74663"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/74663\/revisions"}],"predecessor-version":[{"id":74667,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/74663\/revisions\/74667"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/74664"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=74663"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=74663"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=74663"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}