{"id":25803,"date":"2018-08-06T01:00:00","date_gmt":"2018-08-09T03:38:57","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/08\/09\/%e5%8e%9f%e6%96%99%e8%8d%af%e4%b8%ad%e5%85%83%e7%b4%a0%e6%9d%82%e8%b4%a8%e7%9a%84%e6%b3%95%e8%a7%84%e8%a6%81%e6%b1%82%e5%8f%8a%e6%8e%a7%e5%88%b6%e6%96%b9%e6%b3%95\/"},"modified":"2018-08-09T11:38:59","modified_gmt":"2018-08-09T03:38:59","slug":"%e5%8e%9f%e6%96%99%e8%8d%af%e4%b8%ad%e5%85%83%e7%b4%a0%e6%9d%82%e8%b4%a8%e7%9a%84%e6%b3%95%e8%a7%84%e8%a6%81%e6%b1%82%e5%8f%8a%e6%8e%a7%e5%88%b6%e6%96%b9%e6%b3%95","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/25803\/","title":{"rendered":"\u539f\u6599\u836f\u4e2d\u5143\u7d20\u6742\u8d28\u7684\u6cd5\u89c4\u8981\u6c42\u53ca\u63a7\u5236\u65b9\u6cd5"},"content":{"rendered":"
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\u5143\u7d20\u6742\u8d28\u53c8\u79f0\u91cd\u91d1\u5c5e\uff0c\u91cd\u91d1\u5c5e\u539f\u4e49\u6307\u6bd4\u91cd\u5927\u4e8e<\/span>5\u7684\u91d1\u5c5e\uff0c\u5143\u7d20\u6742\u8d28\u5305\u62ec\u53ef\u80fd\u5b58\u5728\u4e8e\u539f\u6599\u3001\u8f85\u6599\u6216\u5236\u5242\u4e2d\uff0c\u6765\u6e90\u4e8e\u5408\u6210\u4e2d\u50ac\u5316\u5242\u6b8b\u7559\u3001\u836f\u54c1\u751f\u4ea7\u5236\u5907\u8fc7\u7a0b\u4e2d\u5f15\u5165\u6216\u8f85\u6599\u4e2d\u5b58\u5728\u7684\u3001\u751f\u4ea7\u8bbe\u5907\u5f15\u5165\u3001\u6216\u5bb9\u5668\u5bc6\u95ed\u7cfb\u7edf\u5f15\u5165\u3002<\/span>\u67d0\u4e9b\u5143\u7d20\u6742\u8d28\u4e0d\u4ec5\u5bf9\u836f\u54c1\u7684\u7a33\u5b9a\u6027\u3001\u4fdd\u8d28\u671f\u4ea7\u751f\u4e0d\u5229\u5f71\u54cd\uff0c\u8fd8\u53ef\u80fd\u56e0\u4e3a\u6f5c\u5728\u7684\u6bd2\u6027\u5f15\u53d1\u836f\u7269\u526f\u53cd\u5e94\u3002<\/span><\/p>\n


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\u56e0\u6b64\u6b27\u76df\u3001\u7f8e\u56fd\u5bf9\u6742\u8d28\u7684\u63a7\u5236\u8d8a\u6765\u8d8a\u4e25\u683c\uff0c\u5bf9\u6b64\u9879\u4e0d\u65ad\u4fee\u8ba2\uff0c\u4e2d\u56fd\u5728\u52a0\u5165ICH<\/span>\u540e\u5bf9\u6b64\u9879\u68c0\u6d4b\u5e94\u8be5\u4e5f\u4f1a\u5411\u56fd\u9645\u9760\u62e2\uff0c\u56e0\u6b64\u4e86\u89e3\u6cd5\u89c4\u5bf9\u5143\u7d20\u6742\u8d28\u7684\u8981\u6c42\u3001\u5efa\u7acb\u6709\u6548\u7684\u68c0\u6d4b\u65b9\u6cd5\u53d8\u5f97\u5c24\u4e3a\u91cd\u8981\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

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\u58f9<\/p>\n<\/section>\n

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

\u5404\u56fd\u6cd5\u89c4\u53d8\u66f4\u53f2<\/span><\/strong>        <\/p>\n<\/section>\n<\/section>\n<\/section>\n


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

\uff081\uff09<\/span><\/strong>EMA\u3001<\/span>EP<\/span>\u5173\u4e8e\u5143\u7d20\u6742\u8d28\u7684\u4fee\u8ba2<\/span><\/span><\/strong><\/p>\n

 <\/span><\/p>\n

EP\u6700\u65b0\u7248\u4e3a<\/span>9.0<\/span>\u7248\uff0c\u5176\u4e2d\u4fdd\u7559\u4e86<\/span>2.4.8<\/span>\u91d1\u5c5e\u6d4b\u8bd5\u65b9\u6cd5<\/span>A-H<\/span>\uff1b<\/span>2.4.20<\/span>\u7ae0\u8282\u91d1\u5c5e\u50ac\u5316\u5242\u548c\u91d1\u5c5e\u8bd5\u5242\u6b8b\u7559\u68c0\u6d4b\uff1b<\/span>5.20<\/span>\u91d1\u5c5e\u50ac\u5316\u5242\u6216\u91d1\u5c5e\u8bd5\u5242\u6b8b\u7559\u3002\u4f46\u5728<\/span>9.3<\/span>\u589e\u8865\u7248\uff08<\/span>2018<\/span>\u5e74<\/span>1<\/span>\u6708<\/span>1<\/span>\u65e5\u5b9e\u65bd\uff09\u4e2d<\/span>5.20<\/span>\u9879\u4e0b\u89c4\u5b9a\uff0c\u5143\u7d20\u6742\u8d28\u9650\u5ea6\u9075\u5faa<\/span>ICH<\/span>\u8981\u6c42\u3002<\/span>EMA<\/span>\u5bf9\u5143\u7d20\u6742\u8d28\u7684\u4fee\u8ba2\u5982\u4e0b\u8868<\/span>1\u3002<\/span><\/span><\/p>\n


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

\"\u539f\u6599\u836f\u4e2d\u5143\u7d20\u6742\u8d28\u7684\u6cd5\u89c4\u8981\u6c42\u53ca\u63a7\u5236\u65b9\u6cd5\"<\/p>\n


<\/p>\n

\uff082\uff09ICH\u5bf9\u5143\u7d20\u6742\u8d28\u7684\u4fee\u8ba2\u5386\u7a0b<\/span><\/span><\/strong><\/p>\n

 <\/span><\/p>\n

ICH\u4e8e<\/span>2009<\/span>\u5e74<\/span>10<\/span>\u6708\u6279\u51c6\u4e86<\/span>Q3D<\/span>\uff0c\u7ecf\u591a\u65b9\u8ba8\u8bba\u540e\uff0c\u4fee\u8ba2\u7248\u672c\u7684<\/span>Q3D step4<\/span>\u4e8e<\/span>2014<\/span>\u5e74<\/span>12<\/span>\u6708<\/span>16<\/span>\u65e5\u751f\u6548\uff0c\u5176\u4e2d\u5217\u51fa\u4e86<\/span>24<\/span>\u79cd\u5143\u7d20\u6742\u8d28\u7684\u4e09\u79cd\u7ed9\u836f\u9014\u5f84\u7684<\/span>PDE<\/span>\u503c\uff0c\u786e\u5b9a\u5b9e\u65bd\u65e5\u671f\u4e3a\uff1a\u65b0\u4e0a\u5e02\u8bb8\u53ef\u4e3a<\/span>2016<\/span>\u5e74<\/span>6<\/span>\u6708\u751f\u6548\uff0c\u5df2\u4e0a\u5e02\u54c1\u79cd\u4e3a<\/span>2017<\/span>\u5e74<\/span>12<\/span>\u6708\u751f\u6548\u3002<\/span><\/span><\/p>\n

 <\/span><\/strong><\/p>\n

\uff083\uff09USP\u5bf9\u5143\u7d20\u6742\u8d28\u7684\u4fee\u8ba2\u5386\u7a0b<\/span><\/span><\/strong><\/p>\n

 <\/span><\/p>\n

FDA\u89c4\u5b9a\u5728<\/span>2018<\/span>\u5e74<\/span>1<\/span>\u6708<\/span>1<\/span>\u65e5\u4e4b\u540e\uff0c\u9488\u5bf9<\/span>USP<\/span>\u836f\u5178\u54c1\u79cd\uff0c\u63d0\u4ea4\u65b0\u7684<\/span>NDA<\/span>\u3001<\/span>ANDA<\/span>\u5e94\u8be5\u7b26\u5408<\/span>USP<232><\/span>\u3001<\/span><233><\/span>\u3002\u9488\u5bf9\u975e<\/span>USP<\/span>\u836f\u5178\u54c1\u79cd\uff0c\u7533\u8bf7\u4eba\u63d0\u4ea4\u65b0\u7684<\/span>NDA<\/span>\u3001<\/span>ANDA<\/span>\u65f6\uff0c\u5e94\u8be5\u9075\u5faa<\/span>Q3D<\/span>\u3002\u7f8e\u56fd\u5bf9\u5143\u7d20\u6742\u8d28\u7684\u89c4\u5b9a\u4e0e<\/span>ICH<\/span>\u89c4\u5b9a\u5728\u4e0d\u540c\u65f6\u671f\uff0c\u5185\u5bb9\u4e0d\u4e00\u81f4\uff0c\u4f46\u4ece<\/span>2017<\/span>\u5e74<\/span>12<\/span>\u6708\u4e4b\u540e\uff0c<\/span>USP<\/span>\u5bf9\u5143\u7d20\u79cd\u7c7b\u548c\u9650\u91cf\u5747\u4e0e<\/span>ICH<\/span>\u4fdd\u6301\u4e00\u81f4\u3002\u4fee\u8ba2\u5386\u7a0b\u8be6\u89c1\u4e0b\u8868<\/span>2<\/span>\u3002<\/span><\/span><\/p>\n


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

\"\u539f\u6599\u836f\u4e2d\u5143\u7d20\u6742\u8d28\u7684\u6cd5\u89c4\u8981\u6c42\u53ca\u63a7\u5236\u65b9\u6cd5\"<\/p>\n


<\/p>\n

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

\uff084\uff09\u4e2d\u56fd\u836f\u5178\u5bf9\u91cd\u91d1\u5c5e\u68c0\u6d4b\u7684\u4fee\u8ba2<\/span><\/strong><\/p>\n

 <\/span><\/p>\n

\u4e2d\u56fd\u836f\u5178\u5bf9\u91cd\u91d1\u5c5e\u68c0\u6d4b\u7684\u4fee\u8ba2\u4e3b\u8981\u4f53\u73b0\u5728\u8868<\/span>3\u4e2d\uff0c\u540d\u79f0\u4ecd\u7136\u4e3a\u91cd\u91d1\u5c5e\uff0c\u65b9\u6cd5\u4ecd\u91c7\u7528\u6bd4\u8272\u6cd5\uff0c <\/span>2017<\/span>\u5e74\u4e2d\u56fd\u6210\u4e3a\u4e86<\/span>ICH<\/span>\u6210\u5458\u56fd\uff0c\u672a\u6765\u4e2d\u56fd\u7684\u836f\u653f\u76d1\u7ba1\u5c06\u9075\u5faa<\/span>ICH<\/span>\u6307\u5357\u89c4\u5b9a\uff0c\u5143\u7d20\u6742\u8d28\u4e0e\u56fd\u9645\u63a5\u8f68\u4e5f\u662f\u5927\u52bf\u6240\u8d8b\u3002<\/span><\/span><\/p>\n

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

\"\u539f\u6599\u836f\u4e2d\u5143\u7d20\u6742\u8d28\u7684\u6cd5\u89c4\u8981\u6c42\u53ca\u63a7\u5236\u65b9\u6cd5\"<\/p>\n


<\/p>\n

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\u8d30<\/p>\n<\/section>\n

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

ICH\u5bf9\u5143\u7d20\u6742\u8d28\u7684\u5206\u7c7b\u53ca\u9650\u5ea6<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n


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

\uff081\uff09\u5143\u7d20\u6742\u8d28\u5206\u7c7b<\/span><\/strong><\/p>\n

 <\/span><\/p>\n

\u7b2c<\/span>1\u7c7b<\/span> \u5143\u7d20\u7837<\/span>(As)\u3001\u9549<\/span>(Cd)\u3001\u6c5e<\/span>(Hg)\u548c\u94c5<\/span>(Pb)\u662f\u5bf9\u4eba\u6709\u6bd2\u6027\u7684\u7269\u8d28\uff0c\u836f\u54c1\u751f\u4ea7\u4e2d\u4e0d\u5f97\u4f7f\u7528\u6216\u9650\u5236\u4f7f\u7528\uff0c\u901a\u5e38\u6765\u6e90\u4e8e\u77ff\u7269\u8d4b\u5f62\u5242\u3002\u56e0\u6b64\uff0c\u6240\u6709\u7ed9\u836f\u9014\u5f84\u7684\u98ce\u9669\u8bc4\u4f30\u4e2d\u90fd\u5fc5\u987b\u8bc4\u4ef7\u8fd9<\/span>4\u79cd\u5143\u7d20\u3002<\/span> <\/span><\/p>\n

 <\/span><\/p>\n

\u7b2c<\/span>2\u7c7b<\/span> \uff1a\u672c\u7c7b\u522b\u4e2d\u7684\u5143\u7d20\u4e00\u822c\u88ab\u8ba4\u4e3a\u662f\u4e0e\u836f\u7269\u7684\u7ed9\u836f\u9014\u5f84\u6709\u5173\u7684\u7269\u8d28\uff0c\u53c8\u5206<\/span>2A\u3001<\/span>2B\u4e24\u7c7b\u3002<\/span> <\/span><\/p>\n

 <\/span><\/p>\n

2A\u7c7b\uff1a\u5143\u7d20\u94b4<\/span>(Co)\u3001\u954d<\/span>(Ni)\u3001\u9492<\/span>(V)\u3002\u5728\u836f\u54c1\u4e2d\u51fa\u73b0\u53ef\u80fd\u6027\u76f8\u5bf9\u8f83\u9ad8\u7684\u5143\u7d20\uff0c\u56e0\u800c\u9700\u8981\u5bf9\u6240\u6709\u5143\u7d20\u6742\u8d28\u7684\u6f5c\u5728\u6765\u6e90\u53ca\u6240\u6709\u6444\u5165\u9014\u5f84<\/span>(\u5982\u6240\u6307<\/span>)\u8fdb\u884c\u98ce\u9669\u8bc4\u4f30\u3002<\/span> <\/span><\/p>\n

 <\/span><\/p>\n

2B\u7c7b\uff1a\u5143\u7d20\u94f6<\/span>(Ag)\u3001\u91d1<\/span>(Au)\u3001\u94f1<\/span>(Ir)\u3001\u9507<\/span>(Os)\u3001\u9200<\/span>(Pd)\u3001\u94c2<\/span> (Pt)\u3001\u92a0<\/span>(Rh)\u3001\u948c<\/span>(Ru)\u3001\u7852<\/span>(Se)\u3001\u94ca<\/span>(Tl)\uff0c\u8fd9\u4e9b\u5143\u7d20\u5728\u81ea\u7136\u754c\u4e2d\u7a00\u5c11\uff0c\u5728\u836f\u54c1\u4e2d\u51fa\u73b0\u7684\u53ef\u80fd\u6027\u8f83\u4f4e\u3002\u9664\u975e\u5176\u5728\u539f\u6599\u836f\u3001\u8f85\u6599\u6216\u836f\u54c1\u7684\u5176\u5b83\u6210\u5206\u751f\u4ea7\u4e2d\u88ab\u6709\u610f\u52a0\u5165\uff0c\u5426\u5219\u53ef\u88ab\u6392\u9664\u5728\u98ce\u9669\u8bc4\u4f30\u4ee5\u5916\u3002<\/span> <\/span><\/p>\n

 <\/span><\/p>\n

\u7b2c<\/span>3\u7c7b \uff1a\u8fd9\u7c7b\u5143\u7d20\u5305\u62ec\u94a1<\/span>(Ba)<\/span>\u3001\u94ec<\/span>(Cr)<\/span>\u3001\u94dc<\/span>(Cu)<\/span>\u3001\u9502<\/span>(Li)<\/span>\u3001\u94bc<\/span>(Mo)<\/span>\u3001\u9511<\/span>(Sb)<\/span>\u3001\u9521<\/span>(Sn)<\/span>\u3002\u8fd9\u7c7b\u5143\u7d20\u5728\u53e3\u670d\u6444\u5165\u65f6\u5177\u6709\u76f8\u5bf9\u4f4e\u7684\u6bd2\u6027\uff0c\u4f46\u5728\u5438\u5165\u548c\u6ce8\u5c04\u7ed9\u836f\u7684\u98ce\u9669\u8bc4\u4f30\u4e2d\u9700\u8981\u8fdb\u884c\u8003\u8651\u3002\u53e3\u670d\u7ed9\u836f\uff0c\u9664\u975e\u5728\u539f\u6599\u836f\u3001\u8d4b\u5f62\u5242\u6216\u836f\u54c1\u7684\u5176\u4ed6\u7ec4\u5206\u751f\u4ea7\u4e2d\u6709\u610f\u6dfb\u52a0\uff0c\u5426\u5219\u4e0d\u9700\u8981\u5728\u98ce\u9669\u8bc4\u4f30\u4e2d\u8fdb\u884c\u8003\u8651\u3002\u6ce8\u5c04\u548c\u5438\u5165\u7ed9\u836f\uff0c\u9664\u975e\u7ed9\u836f\u9014\u5f84\u7684<\/span>PDE<\/span>\u8d85\u8fc7<\/span>500ug\/day,<\/span>\u5426\u5219\u5728\u98ce\u9669\u8bc4\u4f30\u4e2d\u8981\u8bc4\u4ef7\u8fd9\u4e9b\u5143\u7d20\u51fa\u73b0\u7684\u53ef\u80fd\u6027\u3002 <\/span><\/span><\/p>\n

 <\/span><\/p>\n

\u5176\u4ed6\u5143\u7d20\uff1a<\/span> \u8fd9\u4e9b\u5143\u7d20\u6742\u8d28\u6bd2\u6027\u8f83\u4f4e\u548c<\/span>\/\u6216\u5728\u5730\u65b9\u6cd5\u89c4\u4e2d\u7684\u8981\u6c42\u4e0d\u540c\uff0c\u6ca1\u6709\u89c4\u5b9a<\/span>PDE\uff0c\u5728\u8be5\u6307\u5357\u4e2d\u5e76\u672a\u8bf4\u660e\u3002\u5982\u679c\u8fd9\u4e9b\u5143\u7d20\u51fa\u73b0\u6216\u5305\u62ec\u5728\u836f\u54c1\u4e2d\uff0c\u6309\u7167\u5176\u4ed6\u6307\u5357\u6216\u533a\u57df\u6cd5\u89c4\u8fdb\u884c\u5904\u7406\u3002\u8be5\u7c7b\u5143\u7d20\u5305\u62ec\u94dd<\/span>(AL)\u3001\u787c<\/span>(B)\u3001\u9499<\/span>(Ca)\u3001\u94c1<\/span>(Fe)\u3001\u94be<\/span>(K)\u3001\u9541<\/span>(Mg)\u3001\u9530<\/span>(Mn)\u3001\u94a0<\/span>(Na)\u3001\u94a8<\/span>(W)\u3001\u950c<\/span>(Zn)\u3002\u5982\uff1a<\/span> \u94dd\uff0c\u635f\u5bb3\u80be\u529f\u80fd\uff0c\u9530\u548c\u950c\u5bf9\u809d\u529f\u80fd\u4e0d\u5168\u7684\u75c5\u4eba\u6709\u5bb3\u7b49<\/span><\/span><\/p>\n


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

\uff082\uff0924\u79cd\u5143\u7d20\u6742\u8d28\u7684\u9650\u5ea6<\/span><\/strong><\/p>\n

 <\/span><\/p>\n

\u5bf9\u65e5\u5242\u91cf\u4e0d\u8d85\u8fc7<\/span>10g\/\u5929\u7684\u836f\u54c1\u4e2d\u542b\u6709\u7684\u5143\u7d20\u6742\u8d28\u5141\u8bb8\u6d53\u5ea6\u9650\u5ea6\uff08\u89c1\u8868<\/span>4\uff09\uff0c\u65b9\u6cd5<\/span><\/span>1<\/span>\u5047\u8bbe\u5236\u5242\u4e2d\u6240\u6709\u7ec4\u5206\u90fd\u6ee1\u8db3\u5143\u7d20\u9650\u5ea6\uff0c\u6bcf\u65e5\u836f\u7269\u6444\u53d6\u91cf\u4e0d\u8d85\u8fc7<\/span>10g\uff0c\u4f7f\u7528\u516c\u5f0f<\/span>1\uff0c\u8ba1\u7b97\u51fa\u836f\u54c1\u6bcf\u79cd\u6210\u5206\u7684\u5141\u8bb8\u76ee\u6807\u6d53\u5ea6\u3002<\/span><\/span>\u516c\u5f0f<\/span>1: <\/span><\/p>\n

\u6d53\u5ea6\uff08<\/span> <\/span>\u03bcg<\/span>\/g<\/span>\uff09<\/span>=PDE\uff08<\/span><\/span>\u03bcg<\/span>\/d<\/span>\uff09<\/span>\/\u836f\u7269\u65e5\u7528\u91cf\uff08<\/span>g\/d\uff09<\/span><\/span><\/p>\n

\u82e5\u8868<\/span>4\u4e2d\u5141\u8bb8\u6d53\u5ea6\u4e0d\u9002\u7528\uff0c\u5219\u4f7f\u7528\u65b9\u6cd5<\/span>2a<\/span>\u6216<\/span>2b<\/span>\u8fdb\u884c\u8ba1\u7b97\uff0c\u672c\u6587\u4e0d\u8fdb\u884c\u8d58\u8ff0\uff0c\u8be6\u7ec6\u53c2\u8003<\/span>ICH Q3D<\/span>\u7684\u8ba1\u7b97\u65b9\u6cd5\u3002<\/span><\/span><\/p>\n

\"\u539f\u6599\u836f\u4e2d\u5143\u7d20\u6742\u8d28\u7684\u6cd5\u89c4\u8981\u6c42\u53ca\u63a7\u5236\u65b9\u6cd5\"<\/p>\n

\n


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\n
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\u53c1<\/p>\n<\/section>\n

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

<\/span><\/strong> <\/span>\u5143\u7d20\u6742\u8d28\u7684\u4e00\u822c\u63a7\u5236\u7b56\u7565<\/span><\/strong>   <\/p>\n<\/section>\n<\/section>\n<\/section>\n


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

\u6839\u636e\u5143\u7d20\u6742\u8d28\u7684\u6765\u6e90\u6765\u8fdb\u884c\u63a7\u5236\uff0c\u4e00\u822c\u5143\u7d20\u6742\u8d28\u6765\u6e90\u6709\uff1a<\/span>1\u3001\u539f\u6599\u836f\u3001\u8f85\u6599\u3001\u6216\u5236\u5242\u5176\u4ed6\u7ec4\u5206\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u6709\u610f\u6dfb\u52a0\u7684\uff0c\u5982\u91d1\u5c5e\u50ac\u5316\u5242\uff1b<\/span>2<\/span>\u3001\u5236\u836f\u7528\u6c34\u6216\u8f85\u6599\u3001\u539f\u6599\u7b49\uff1b<\/span>3<\/span>\u3001\u539f\u6599\u836f\u6216\u5236\u5242\u751f\u4ea7\u8bbe\u5907\u5f15\u5165\uff1b<\/span>4<\/span>\u3001\u539f\u6599\u836f\u6216\u5236\u5242\u5bb9\u5668\u5bc6\u95ed\u7cfb\u7edf\u5f15\u5165\u7684\uff0c\u4e00\u822c\u56fa\u4f53\u5236\u5242\u5bc6\u95ed\u7cfb\u7edf\u6d78\u51fa\u53ef\u80fd\u6027\u5c0f\uff0c\u6db2\u4f53\u6216\u534a\u56fa\u4f53\u5236\u5242\uff0c\u5728\u50a8\u5b58\u8fc7\u7a0b\u4e2d\u5f15\u5165\u5143\u7d20\u6742\u8d28\u7684\u53ef\u80fd\u6027\u8f83\u9ad8\u3002<\/span><\/span><\/p>\n

 <\/span><\/p>\n

\u5bf9\u4e8e\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u6709\u610f\u6216\u65e0\u610f\u6dfb\u52a0\u7684\uff0c\u53ef\u901a\u8fc7\u6539\u8fdb\u5de5\u827a\u6b65\u9aa4\uff0c\u4f7f\u7528\u7279\u5b9a\u6216\u975e\u7279\u5b9a\u7684\u7cbe\u5236\u6b65\u9aa4\u5c06\u5143\u7d20\u6742\u8d28\u51cf\u4f4e\u81f3\u63a7\u5236\u9608\u503c\u4ee5\u4e0b\uff1b\u9009\u62e9\u751f\u4ea7\u8bbe\u5907\u3001\u8bbe\u5907\u9a8c\u8bc1\u53ca<\/span>GMP\u89c4\u8303\u6765\u964d\u4f4e\uff1b\u5236\u836f\u7528\u6c34\u5219\u9700\u4e25\u683c\u9075\u5b88\u5404\u836f\u5178\u5bf9\u5236\u836f\u7528\u6c34\u7684\u8d28\u91cf\u8981\u6c42\u6765\u964d\u4f4e\uff1b\u6216\u5b9e\u65bd\u4e2d\u63a7\u6216\u8005\u4e0a\u6e38\u63a7\u5236\uff0c\u63a7\u5236\u5143\u7d20\u6742\u8d28\u6d53\u5ea6\uff0c\u5efa\u7acb\u8f85\u6599\u6216\u539f\u6599\u836f\u4e2d\u95f4\u4f53\u7684\u8d28\u91cf\u6807\u51c6\u9650\u5ea6\uff0c\u5efa\u7acb\u539f\u6599\u836f\u8d28\u91cf\u6807\u51c6\u9650\u5ea6\u3002\u9488\u5bf9\u5bc6\u95ed\u7cfb\u7edf\u5f15\u5165\u7684\u5e94\u5f53\u9009\u62e9\u9002\u5f53\u7684\u5bb9\u5668\u5305\u88c5\u7cfb\u7edf\u3002<\/span><\/span><\/p>\n


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\u8086<\/p>\n<\/section>\n

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 <\/span>\u5143\u7d20\u6742\u8d28\u7684\u68c0\u6d4b\u65b9\u6cd5\u7684\u6bd4\u8f83<\/span><\/strong>   <\/p>\n<\/section>\n<\/section>\n<\/section>\n


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

\uff081\uff09 \u6bd4\u8272\u6cd5<\/span><\/strong><\/p>\n


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

\u6bd4\u8272\u6cd5\u4e3a\u5148\u6709\u4e2d\u56fd\u836f\u5178\u91c7\u7528\u65b9\u6cd5<\/span>\uff0c<\/span>\u4e3b\u8981\u662f\u91cd\u91d1\u5c5e\u4e0e\u786b\u4ee3\u4e59\u9170\u80fa\u53cd\u5e94\u4ea7\u751f\u786b\u5316\u7269\u6c89\u6dc0<\/span>\uff0c<\/span>\u5c06\u6c89\u6dc0\u7269\u53cd\u5e94\u663e\u8272\u4e0e<\/span>10ppm\u7684\u6807\u51c6\u94c5\u8fdb\u884c\u76ee\u89c6\u5bf9\u6bd4\uff0c\u5b9a\u6027\u5206\u6790\u91cd\u91d1\u5c5e\u662f\u5426\u8d85\u6807\uff0c\u8fd9\u4e00\u65b9\u6cd5\u6d4b\u8bd5\u7ed3\u679c\u4e0d\u51c6\u786e\u3001\u7f3a\u4e4f\u4e13\u5c5e\u6027\u3001\u7075\u654f\u5ea6\uff0c\u800c\u4e14\u7ed3\u679c\u663e\u793a\u662f\u91cd\u91d1\u5c5e\u7684\u603b\u91cf\u503c\uff0c\u4e0d\u80fd\u5f88\u597d\u663e\u793a\u5177\u6709\u9057\u4f20\u6bd2\u7684\u91d1\u5c5e\u5143\u7d20\u6742\u8d28\u7684\u6b8b\u7559\u91cf\u3002<\/span><\/span><\/p>\n


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

\uff082\uff09ICP-MS\u6cd5<\/span><\/strong><\/p>\n


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

EP\u4e13\u8bba\u4e2d<\/span>2.4.20<\/span>\u63d0\u53ca\u65b9\u6cd5\uff0c\u8fd9\u4e00\u65b9\u6cd5\u68c0\u51fa\u9650\u4f4e\uff0c\u53ef\u81f3<\/span>ppt<\/span>\u7ea7\u522b\u6b8b\u7559\u7269\uff0c\u7ebf\u6027\u8303\u56f4\u5bbd\uff0c\u5149\u8c31\u4e5f\u6bd4\u8f83\u7b80\u5355\uff0c\u9002\u7528\u4e8e\u540c\u4f4d\u7d20\u5206\u6790\u3002\u4f46\u5176\u5149\u8c31\u5e72\u6270\u4e25\u91cd\uff0c\u8010\u76d0\u6027\u5dee\uff0c\u5728\u76d0\u6761\u4ef6\u4e0b\uff0c\u68c0\u51fa\u4f18\u70b9\u5dee<\/span>50<\/span>\u500d\uff0c\u8f7b\u5143\u7d20\uff08\u5982<\/span>Ca<\/span>\u3001<\/span>K<\/span>\u7b49\uff09\u4f1a\u4ea7\u751f\u4e25\u91cd\u5e72\u6270\uff0c\u6076\u5316\u5176\u68c0\u51fa\u9650\u3002\u66f4\u91cd\u8981\u7684\u662f\uff0c\u8fd9\u4e00\u65b9\u6cd5\u68c0\u6d4b\u6210\u672c\u9ad8\uff0c\u4eea\u5668\u7ef4\u62a4\u9891\u7e41\u3002<\/span><\/span><\/p>\n


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

\uff083\uff09ICP-AES<\/span><\/strong><\/p>\n


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

EP\u4e13\u8bba\u4e2d<\/span>2.4.20<\/span>\u63d0\u53ca\u65b9\u6cd5\uff0c\u8fd9\u4e00\u65b9\u6cd5\u7684\u68c0\u51fa\u9650\u9ad8\u4e8e<\/span>ICP-MS<\/span>\uff0c\u53ef\u8fbe\u5230<\/span>1-10ppb<\/span>\u7ea7\u522b\uff0c\u7cbe\u5bc6\u5ea6\u8ddf\u51c6\u786e\u5ea6\u9ad8\uff0c\u7ebf\u6027\u8303\u56f4\u4e5f\u8f83\u5bbd\uff0c\u53ef\u4ee5\u540c\u65f6\u6d4b\u5b9a\u591a\u79cd\u5143\u7d20\u3002\u4f46\u5176\u83b7\u5f97\u7684\u8c31\u7ebf\u590d\u6742\uff0c\u7531\u4e8e\u4e25\u91cd\u7684\u5149\u8c31\u5e72\u6270\uff0c\u5206\u6790\u6d4b\u8bd5\u80fd\u529b\u964d\u4f4e\u3002\u4eea\u5668\u7ef4\u62a4\u6210\u672c\u76f8\u5bf9<\/span>ICP-MS<\/span>\u4f4e\uff0c\u4f46\u76f8\u5bf9\u539f\u5b50\u5206\u5149\u5149\u5ea6\u6cd5\u9ad8\u3002<\/span><\/p>\n


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

\uff084\uff09\u539f\u5b50\u5438\u6536\u5206\u5149\u5149\u5ea6\u6cd5\uff08FAAS  GFAAS\uff09<\/span><\/strong><\/p>\n


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

FAAS\u5e38\u7528\u4e8e<\/span>Na<\/span>\u3001<\/span>K<\/span>\u3001<\/span>Ca<\/span>\u3001<\/span>Mg<\/span>\u3001<\/span>Fe<\/span>\u3001<\/span>Zn<\/span>\u3001<\/span>Li<\/span>\u7b49\u5143\u7d20\u7684\u5206\u6790\uff0c\u68c0\u6d4b\u9650\u5ea6\u4e3a<\/span>ppm<\/span>\u7ea7\uff0c\u76f8\u5bf9\u4e8e\u4ee5\u4e0a\u4e24\u79cd\uff0c\u8d39\u7528\u4fbf\u5b9c\uff0c\u64cd\u4f5c\u7b80\u5355\uff0c\u91cd\u73b0\u6027\u8f83\u597d\u3002\u4f46\u5176\u4e00\u6b21\u68c0\u6d4b\u53ea\u80fd\u68c0\u6d4b\u4e00\u79cd\u5143\u7d20\uff0c\u9700\u8981\u914d\u5907\u591a\u4e2a\u706f\uff0c\u57fa\u4f53\u7684\u5e72\u6270\u6bd4\u8f83\u4e25\u91cd\uff0c\u7ebf\u6027\u8303\u56f4\u4e5f\u8f83\u7a84\uff0c\u5206\u6790\u901f\u5ea6\u4e5f\u6ca1\u6709\u524d\u8ff0\u4e24\u79cd\u5feb\u3002<\/span><\/p>\n

 <\/span><\/p>\n

GFAAS\u6bd4\u8f83\u9002\u7528\u4e8e<\/span>Pb<\/span>\u3001<\/span>Au<\/span>\u3001<\/span>Al<\/span>\u7b49\u68c0\u6d4b\uff0c\u5206\u6790\u6240\u9700\u6837\u54c1\u91cf\u5c11\uff0c\u9002\u7528\u4e8e\u8d35\u91cd\u7269\u54c1\u5206\u6790\uff0c\u68c0\u6d4b\u7075\u654f\u5ea6\u8f83<\/span>FAAS<\/span>\u9ad8\uff0c\u4eea\u5668\u4e0d\u8d35\uff0c\u64cd\u4f5c\u7b80\u5355\uff0c\u91cd\u73b0\u6027\u8f83\u597d\u3002\u4f46\u5176\u8017\u6750\u504f\u8d35\uff0c\u5f00\u53d1\u65b9\u6cd5\u8d39\u65f6\u3002<\/span><\/span><\/p>\n


<\/p>\n

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\u4f0d<\/p>\n<\/section>\n

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 <\/span>\u6848\u4f8b\u5206\u6790   <\/span><\/strong>   <\/p>\n<\/section>\n<\/section>\n<\/section>\n


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

\u67d0\u53e3\u670d\u7ed9\u836f\u5236\u5242\uff0c\u539f\u6599\u836f\u5408\u6210\u5de5\u827a\u4e2d\u4f7f\u7528\u94af\u91d1\u5c5e\u50ac\u5316\u5242\uff0c\u4e14\u5728\u7b2c\u4e8c\u6b65\u4f7f\u7528\u5230\u6b64\u50ac\u5316\u5242\uff0c\u6839\u636e<\/span>ICH\u89c4\u5b9a\uff0c\u94af\u5c5e\u4e8e<\/span>2B<\/span>\u7c7b\u91d1\u5c5e\uff0c\u6839\u636e\u4e4b\u524d<\/span>EMA<\/span>\u7684\u5bf9\u91d1\u5c5e\u50ac\u5316\u5242\u6b8b\u7559\u7684\u76f8\u5173\u89c4\u5b9a\u53ca\u5176\u89e3\u91ca\uff1a\u5728\u5408\u6210\u6700\u7ec8\u6b65\u9aa4\u4e4b\u524d\u5f62\u6210\u6216\u5f15\u5165\u4e00\u7c7b\u91cd\u91d1\u5c5e\uff0c\u5728\u5408\u6210\u4e2d\u95f4\u4f53\u4e2d\u901a\u8fc7\u9002\u5f53\u7684\u9650\u5ea6\u8fdb\u884c\u63a7\u5236\uff0c\u4e14\u68c0\u9a8c\u7ed3\u679c\u5df2\u6e05\u695a\u8bc1\u660e\u8be5\u91d1\u5c5e\u5b58\u5728\u7684\u6c34\u5e73\u4e0d\u8d85\u8fc7\u9650\u5ea6\u6307\u5357\u7684<\/span>30%<\/span>\uff0c\u53ef\u4ee5\u8003\u8651\u5728\u6210\u54c1\u7684\u8d28\u91cf\u6807\u51c6\u4e2d\u4e0d\u5305\u62ec\u8be5\u91d1\u5c5e\u3002<\/span><\/span><\/p>\n


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

\u53c2\u8003\u8fd9\u4e00\u89e3\u91ca\u89c4\u5b9a\uff0c\u5bf9\u4e8e\u5408\u6210\u53cd\u5e94\u4e2d\u7b2c\u4e8c\u6b65\u5f15\u5165\u7684<\/span>2B<\/span>\u7c7b\u91cd\u91d1\u5c5e\u50ac\u5316\u5242\u6b8b\u7559\uff0c\u7406\u5e94\u8003\u8651\u5728\u7b2c\u4e8c\u6b65\u4ea7\u751f\u7684\u4e2d\u95f4\u4f53\u4e2d\u8fdb\u884c\u63a7\u5236\uff0c\u4f46\u8003\u8651\u5230\u7b2c\u4e09\u6b65\u7684\u53cd\u5e94\u5939\u5e26\u53ca\u7b2c\u4e94\u6b65\u7684\u53cd\u5e94\u7cbe\u5236\u6b65\u9aa4\uff0c\u94af\u7684\u6b8b\u7559\u4f1a\u5c0f\u5f88\u591a\uff0c\u540c\u65f6\u8003\u8651\u5230\u94af\u7684\u9650\u5ea6\u4ec5<\/span>10ppm<\/span>\uff0c\u5728\u7b2c\u4e8c\u90e8\u4ea7\u751f\u4e2d\u95f4\u4f53\u4e2d\u8fdb\u884c\u63a7\u5236\uff0c\u5f88\u5bb9\u6613\u8d85\u6807\u3002\u6545\u9009\u62e9\u5728\u7b2c\u4e94\u6b65\u53cd\u5e94\u4ea7\u751f\u4e2d\u95f4\u4f53\u4e2d\u68c0\u6d4b\u6b64\u91cd\u91d1\u5c5e\u6b8b\u7559\u60c5\u51b5\uff0c\u91c7\u7528<\/span>ICP-MS<\/span>\u6cd5\u8fdb\u884c\u68c0\u6d4b\u3002\u7ecf\u8fc7\u68c0\u6d4b\uff0c\u5176\u7ed3\u679c\u5c0f\u4e8e\u9650\u5ea6\u7684<\/span>30%<\/span>\uff0c\u65e5\u5e38\u68c0\u6d4b\u53ef\u4ee5\u91c7\u7528\u8df3\u68c0\u7684\u65b9\u5f0f\u8fdb\u884c\u63a7\u5236\u3002<\/span><\/span><\/p>\n

 <\/span><\/p>\n

\u53e6\u5916\uff0c\u5bf9\u4e8e\u4e00\u7c7b\u91d1\u5c5e\u3001<\/span>2A\u7c7b\u91d1\u5c5e\uff0c\u82e5\u5728\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u8bbe\u5907\u3001\u5236\u836f\u7528\u6c34\u6709\u53ef\u80fd\u4f1a\u5939\u5e26\u5f15\u5165\uff0c\u9700\u8981\u5bf9\u5176\u8fdb\u884c\u4e0d\u5b58\u5728\u9a8c\u8bc1\uff0c\u68c0\u6d4b\u4e2d\u8bd5<\/span>6<\/span>\u6279\u6216\u5546\u4e1a<\/span>3<\/span>\u6279\uff0c\u82e5\u5747\u68c0\u6d4b\u4e0d\u5230\u6216\u8fdc\u4f4e\u4e8e\u9650\u5ea6\u89c4\u5b9a\uff0c\u5219\u65e0\u9700\u5b9a\u5165\u8d28\u91cf\u6807\u51c6\uff0c\u82e5\u68c0\u6d4b\u5230\uff0c\u4e14\u4f4e\u4e8e\u9650\u5ea6<\/span>30%<\/span>\uff0c\u5219\u6839\u636e\u9700\u8981\u914c\u60c5\u5904\u7406\u3002<\/span><\/span><\/p>\n


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\u7efc\u4e0a\u6240\u8ff0\uff0c\u9488\u5bf9\u4e0d\u540c\u60c5\u51b5\uff0c\u53ef\u4ee5\u9009\u7528\u4e0d\u540c\u4eea\u5668\u3001\u65b9\u6cd5\u8fdb\u884c\u68c0\u6d4b\uff0c\u4ee5\u8fbe\u5230\u5373\u53ef\u6ee1\u8db3\u68c0\u6d4b\u9650\u8981\u6c42\uff0c\u53c8\u53ef\u7701\u65f6\u3001\u7701\u529b\u3001\u7701\u94b1\u3002\u603b\u4f53\u6765\u8bf4\uff0c\u6bd4\u8272\u6cd5\u5728\u672a\u6765\u53ef\u80fd\u4f1a\u88ab\u5176\u4ed6\u51e0\u79cd\u65b9\u6cd5\u66ff\u4ee3\u3002\u53e6\u5916\u5bf9\u4e8e\u5143\u7d20\u6742\u8d28\u7684\u98ce\u9669\u63a7\u5236\u800c\u8a00\uff0c\u9700\u8981\u5404\u90e8\u95e8\u914d\u5408\uff0c\u5236\u5b9a\u5408\u9002\u3001\u5408\u7406\u7684\u68c0\u6d4b\u65b9\u6cd5\u3001\u9650\u5ea6\uff0c\u505a\u5230\u65e2\u4e0d\u6d6a\u8d39\u4eba\u529b\u3001\u7269\u529b\uff0c\u53c8\u53ef\u51c6\u786e\u628a\u63a7\u98ce\u9669\u3002<\/span><\/p>\n

 <\/span> <\/span><\/strong><\/p>\n

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

(1)ICH\uff0eICH Q3D Guideline for Elemental Impurities<\/span><\/p>\n

(2)European Pharmacopoeia Commission\uff0eEuropean Pharmacopoeia 9.0<\/span><\/p>\n

(3)<\/span>Ball D\uff0cBlanchard J\uff0cJacobson-Kram D\uff0c et a1\uff0eDevelopment of Safety Qualification Thresholds and Their Use in 0rally Inhaled and Nasal Drug Product Evaluation[J]\uff0eToxicoI Sci\uff0c2007\uff0c97(2)\uff1a226-236<\/span><\/p>\n

(4)<\/span> U.S. Pharmacopeia Convention -USP40<\/span><\/p>\n

(5)<\/span>European Pharmacopoeia  Comments concerning revised texts published in Supplement 9.3<\/span><\/p>\n

(6)<\/span>IPCS\uff0eEnvironmental Health Criteria 240 Principles and Methods for the Risk Assessment of Chemicals in Food\u3002Chapter 5\uff1aDose Response Assessment and Derivation of Health Based Guidance Values(s)\uff0eGeneva World  Health organization\uff0c2009\uff0e<\/span><\/p>\n

<\/span>(7)<\/span><\/span><\/span>www.ema.europa.eu<\/span> <\/span><\/span><\/p>\n


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\u6392\u7248\uff1a\u9621\u4e0a\u964c\u964c<\/span><\/p>\n

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