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\u2014\u2014\u672c\u6587\u6765\u81eaPDA 7\u670815\u65e5\u7535\u5b50\u6742\u5fd7\uff0c\u7ffb\u8bd1\u5e2e\u52a9\uff1aJulia\u6731\u7389\u5a07\uff0f<\/span><\/strong>\u539f\u6587\u5b98\u7f51\u94fe\u63a5\uff1a<\/span><\/span><\/p>\n

http:\/\/journal.pda.org\/content\/72\/3\/332.full.pdf+html<\/span><\/p>\n

\u2014\u2014
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\u5173\u4e8eGMP\u8bb0\u5f55\u526f\u672c<\/span><\/p>\n


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\u5173\u4e8e\u4e2a\u4eba\u65e5\u8bb0<\/span><\/strong><\/span><\/strong><\/p>\n


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\u95ee\u9898\uff1a\u4ec0\u4e48\u7c7b\u578b\u7684\u8f93\u5165\/\u4fe1\u606f\u53ef\u4ee5\u8bb0\u5f55\u5728\u4e2a\u4eba\u65e5\u8bb0\u4e2d\u800c\u4e0d\u4f1a\u88ab\u8ba4\u4e3a\u662fGMP\u8bb0\u5f55\u5462\uff1f<\/span><\/span><\/p>\n


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\u6f84\u6e05\uff1a\u5982\u679c\u7b14\u8bb0\u548c\u65e5\u8bb0\u7528\u4f5c\u4e2a\u4eba\u8bb0\u5f55\u53c2\u8003\u4fe1\u606f\u7684\u65b9\u6cd5\uff0c\u5e76\u4e0d\u662fGMP\u6d3b\u52a8\u6267\u884c\u6216\u6587\u4ef6\u5316\u7684\u8bb0\u5f55\u7cfb\u7edf\uff0c\u5219\u5e76\u4e0d\u4f1a\u8ba4\u4e3a\u5b83\u4eec\u662fGMP\u8bb0\u5f55\u3002\u8fd9\u4e9b\u5199\u5728\u4e2a\u4eba\u7b14\u8bb0\u672c\u4e0a\u7684\u975e\u6b63\u5f0f\u8bb0\u5f55\u53ef\u80fd\u5305\u62ec\u4efb\u52a1\u6e05\u5355\u3001\u57f9\u8bad\u7b14\u8bb0\u3001\u6559\u5bfc\u60f3\u6cd5\u4ee5\u53ca\u4e2a\u4eba\u4fe1\u606f\u7b49\u3002\u516c\u53f8\u53ef\u80fd\u60f3\u8fdb\u884c\u63a7\u5236\uff0c\u5e76\u62bd\u67e5\u4e2a\u4eba\u7b14\u8bb0 \u4ee5\u786e\u4fdd\u5458\u5de5\u53ea\u4f1a\u5c06\u5176\u7528\u4e8e\u975eGMP\u4fe1\u606f\u8bb0\u5f55\u3002\u516c\u53f8\u4ea6\u53ef\u80fd\u60f3\u8981\u57f9\u8bad\u5458\u5de5\uff0c\u544a\u77e5\u5176\u5728\u4e2a\u4eba\u7b14\u8bb0\u4e2d\u8bb0\u5f55\u4ec0\u4e48\u662f\u6070\u5f53\u7684\uff0c\u4ee5\u53ca\u8bb0\u5f55\u4ec0\u4e48\u662f\u4e0d\u6070\u5f53\u7684\u3002<\/span><\/p>\n


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

\u5173\u4e8eGMP\u6587\u4ef6\u7684\u8349\u7a3f<\/span><\/strong><\/span><\/strong><\/span><\/p>\n


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

\u80cc\u666f\uff1a<\/span>\u516c\u53f8\u4f1a\u4ea7\u751f\u5f88\u591aCGMP\u6587\u4ef6\u7684\u8349\u6848\u3002\u5982\u679c\u8981\u6c42\u4fdd\u7559\u6240\u6709\u8fd9\u4e9b\u6587\u4ef6\uff0c\u53ef\u80fd\u4f1a\u5f88\u9ebb\u70e6\u5e76\u9020\u6210\u6df7\u6dc6\u3002<\/span><\/span><\/p>\n


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

\u95ee\uff1a\u516c\u53f8\u9700\u8981\u4fdd\u5b58CGMP\u6587\u4ef6\u7684\u8349\u6848\u5417\uff1f\u5982\u98ce\u9669\u8bc4\u4f30\u62a5\u544a\u3001\u8c03\u67e5\u62a5\u544a\u548c\u9a8c\u8bc1\u62a5\u544a\u8349\u6848<\/span><\/span><\/p>\n


<\/p>\n

\u6f84\u6e05\uff1a\u4e00\u65e6GMP\u6587\u4ef6\u6700\u7ec8\u6210\u7a3f\uff0c\u5c31\u4e0d\u9700\u8981\u4fdd\u7559\u7528\u4e8e\u8bb0\u5f55\u6587\u4ef6\u521b\u5efa\u7684\u6587\u4ef6\u548c\u8349\u6848\u4e86\u3002\u5176\u4e2d\u5305\u62ec\u6709\u5728\u6267\u884c\u8c03\u67e5\u8fc7\u7a0b\u4e2d\u4f7f\u7528\u6216\u521b\u5efa\u7684\u6587\u4ef6\u548c\u8349\u6848\u3002\u6700\u7ec8\u6587\u4ef6\u662f\u8bb0\u5f55\u6587\u4ef6\u3002\u4e00\u65e6\u6b63\u5f0f\u6279\u51c6\u4e86\u4e00\u4efdGMP\u6587\u4ef6\uff0c\u5219GMP\u53d8\u66f4\u63a7\u5236\u6d41\u7a0b\u751f\u6548\u3002\u4f5c\u4e3a\u4fdd\u6301GMP\u6587\u4ef6\u63a7\u5236\u7684\u4e00\u90e8\u5206\uff0c\u5efa\u8bae\u786e\u4fdd\u8349\u6848\u53ef\u4ee5\u660e\u663e\u533a\u522b\u4e8e\u6700\u7ec8\u6587\u4ef6\uff08\u4f8b\u5982\uff0c\u76d6\u6709\u201c\u8349\u6848\u201d\u5370\u7ae0\uff09\u3002<\/span><\/p>\n


<\/p>\n

\u5173\u4e8e\u7535\u5b50\u90ae\u4ef6\u4f5c\u4e3aGMP\u8bb0\u5f55<\/span><\/strong><\/span><\/strong><\/span><\/p>\n


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

\u80cc\u666f\uff1a<\/span>\u516c\u53f8\u4f7f\u7528\u7535\u5b50\u90ae\u4ef6\u6709\u4e0d\u540c\u7684GMP\u548c\u975eGMP\u76ee\u7684\u3002\u8bb8\u591a\u516c\u53f8\u4e0d\u592a\u6e05\u695a\u54ea\u79cd\u4f7f\u7528\u65b9\u6cd5\u7b97\u662fGMP\u7528\u9014\uff0c\u516c\u53f8\u7684\u6574\u4e2a\u7535\u5b50\u90ae\u4ef6\u7cfb\u7edf\u662f\u5426\u8981\u56e0\u4e3a\u6b64\u7c7b\u7528\u9014\u800c\u6210\u4e3a\u4e00\u4e2aGMP\u7cfb\u7edf\u3002<\/span><\/span><\/p>\n


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

\u95ee\uff1a\u7535\u5b50\u90ae\u4ef6\u4f1a\u88ab\u8ba4\u4e3a\u662fGMP\u8bb0\u5f55\u5417\uff1f<\/span><\/span><\/p>\n


<\/p>\n

\u6f84\u6e05\uff1a\u7535\u5b50\u90ae\u4ef6\u662f\u5426GMP\u8bb0\u5f55\u53d6\u51b3\u4e8e\u4ed6\u4eec\u662f\u5426\u88ab\u7528\u4e8e\u4ea4\u6d41GMP\u884c\u52a8\u6216\u5185\u5bb9\u6216\u83b7\u53d6GMP\u51b3\u7b56\u3002<\/span><\/p>\n


<\/p>\n

\u4f8b\u5982\uff0c\u5982\u679c\u7535\u5b50\u90ae\u4ef6\u88ab\u7528\u4f5c\u6279\u653e\u884c\u8bb0\u5f55\u7cfb\u7edf\uff0c\u5219\u8fd9\u4e9b\u7535\u5b50\u90ae\u4ef6\u5c31\u662fGMP\u8bb0\u5f55\uff0c\u5e76\u4e14\u5185\u90e8\u9700\u8981\u6709\u7a0b\u5e8f\u5199\u6e05\u695a\u8bb0\u5f55\u7cfb\u7edf\u662f\u4ec0\u4e48\u3002\u5982\u679c\u7535\u5b50\u90ae\u4ef6\u88ab\u7528\u4e8e\u4ea4\u6d41\u4e00\u4e2a\u6279\u6b21\u662f\u5426\u5df2\u7ecf\u88ab\u5904\u7f6e\uff0c\u4f46\u8be5\u51b3\u7b56\u662f\u4f9d\u636e\u516c\u53f8\u7684SOP\u4ece\u5176\u5b83\u5730\u65b9\u83b7\u53d6\u7684\uff0c\u5219\u8be5\u7535\u5b50\u90ae\u4ef6\u5c31\u4e0d\u662fGMP\u8bb0\u5f55\u3002\u7c7b\u4f3c\u5730\uff0c\u5982\u679c\u7535\u5b50\u90ae\u4ef6\u4f9d\u636e\u516c\u53f8SOP\u88ab\u7528\u4f5c\u8d28\u91cf\u95ee\u9898\u5347\u7ea7\u5904\u7406\u7684\u6b63\u5f0f\u7cfb\u7edf\uff0c\u5219\u8fd9\u4e9b\u90ae\u4ef6\u5c31\u662fGMP\u8bb0\u5f55\u3002\u5982\u679c\u7535\u5b50\u90ae\u4ef6\u88ab\u7528\u4f5c\u901a\u77e5\u63d0\u9192\u8be5\u5347\u7ea7\u5904\u7406\u4e8b\u4ef6\uff0c\u5e76\u4e14\u8fd8\u6709\u53e6\u4e00\u4e2a\u5355\u72ec\u7684\u7cfb\u7edf\u7528\u4f5c\u5347\u7ea7\u8bb0\u5f55\uff0c\u5219\u8be5\u7535\u5b50\u90ae\u4ef6\u5c31\u4e0d\u662fGMP\u8bb0\u5f55\u3002\u5728GMP\u6d41\u7a0b\u4e2d\u4f7f\u7528\u7535\u5b50\u90ae\u4ef6\u5e94\u5728\u76f8\u5173SOP\u4e2d\u6e05\u695a\u63cf\u8ff0\u3002<\/span><\/p>\n


<\/p>\n

\u4e3a\u4e86\u521b\u5efa\u4e00\u4efd\u72ec\u7acb\u4e8e\u7535\u5b50\u90ae\u4ef6\u7cfb\u7edf\u4ee5\u5916\u7684GMP\u8bb0\u5f55\uff0c\u4e5f\u4e3a\u4e86\u907f\u514d\u4f7f\u7528\u7535\u5b50\u90ae\u4ef6\u7cfb\u7edf\u4f5c\u4e3aGMP\u8bb0\u5f55\u7cfb\u7edf\uff0c\u516c\u53f8\u53ef\u80fd\u4f1a\u5e0c\u671b\u8003\u8651\u5c06\u6240\u6709\u542b\u6709GMP\u8bb0\u5f55\u7684\u76f8\u5173\u90ae\u4ef6\u6253\u5370\u51fa\u6765\u5e76\u7b7e\u540d\u52a0\u65e5\u671f\u3002\u6240\u6709\u8fd9\u4e9b\u64cd\u4f5c\u5747\u5e94\u4f9d\u636e\u4e66\u9762SOP\u5b8c\u6210\u3002<\/span><\/p>\n


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

\u5173\u4e8e\u4e0d\u662fGMP\u8bb0\u5f55\u7684\u5546\u52a1\u8bb0\u5f55<\/span><\/strong><\/span><\/strong><\/span><\/p>\n


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

\u80cc\u666f\uff1a<\/span>\u6700\u8fd1\u7684\u5b98\u65b9\u68c0\u67e5\u5f00\u59cb\u67e5\u9605\u975eGMP\u8bb0\u5f55\u7684\u5546\u52a1\u8bb0\u5f55\uff0c\u5982\u5b89\u4fdd\u5f55\u50cf\u3001GMP\u6587\u4ef6\u5982\u8c03\u67e5\u6587\u4ef6\u7684\u8349\u6848\u3001\u975e\u53d7\u63a7\u6587\u4ef6\u526f\u672c\uff0c\u4ee5\u53ca\u5b89\u5168\u94a5\u5319\u5361\u51fa\u5165\u7cfb\u7edf\u3002FDA\u53ef\u80fd\u4f1a\u9009\u62e9\u68c0\u67e5\u8fd9\u4e9b\u9879\u76ee\uff0c\u751a\u81f3\u53ef\u80fd\u5229\u7528\u5176\u4f5c\u4e3a\u53d1\u73b0GMP\u8fdd\u89c4\u884c\u4e3a\u7684\u65b9\u6cd5\u3002\u4f46\u662f\uff0c\u8fd9\u4e9b\u8bb0\u5f55\u53ef\u80fd\u4f1a\u88ab\u68c0\u67e5\u7684\u4e8b\u5b9e\u5e76\u4e0d\u8868\u793a\u8fd9\u4e9b\u4e8b\u7269\u90fd\u662fGMP\u8bb0\u5f55\u3002\u5426\u5219\uff0c\u5c06\u4f1a\u5bf9\u8d28\u91cf\u90e8\u95e8\u9020\u6210\u5de8\u5927\u7684\u8d1f\u62c5\uff0c\u65b9\u53ef\u5bf9\u65b0\u7c7b\u578b\u7684\u8bb0\u5f55\u8fdb\u884c\u5ba1\u6838\u548c\u63a7\u5236\u3002<\/span><\/span><\/p>\n


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

\u95ee\uff1a\u5982\u679c\u8981\u68c0\u67e5\u975eGMP\u8bb0\u5f55\uff0c\u5982\u5b89\u4fdd\u5f55\u50cf\u3001GMP\u6587\u4ef6\u5982\u8c03\u67e5\u7684\u8349\u6848\u3001\u975e\u53d7\u63a7\u6587\u4ef6\u526f\u672c\uff0c\u4ee5\u53ca\u5b89\u5168\u94a5\u5319\u5361\u51fa\u5165\u7cfb\u7edf\uff0c\u662f\u5426\u8868\u793a\u8fd9\u4e9b\u90fd\u88ab\u8ba4\u4e3a\u662fGMP\u8bb0\u5f55\uff1f<\/span><\/span><\/p>\n


<\/p>\n

\u6f84\u6e05\uff1a\u4e0d\u662f\u3002\u6240\u6709\u4e3a\u4e86\u6ee1\u8db3CGMP\u8981\u6c42\u800c\u751f\u6210\u7684\u6570\u636e\u662fCGMP\u8bb0\u5f55\u3002\u4f46\u975eGMP\u8bb0\u5f55\u53ef\u80fd\u4f1a\u88ab\u68c0\u67e5\uff0c\u6216\u53ef\u80fd\u6210\u4e3a\u4e0eGMP\u95ee\u9898\u6709\u5173\u7684\u68c0\u67e5\u7f3a\u9677\u7684\u6765\u6e90\u7684\u4e8b\u5b9e\uff0c\u5e76\u4e0d\u4f1a\u5c06\u53d7\u68c0\u67e5\u7684\u975eGMP\u8bb0\u5f55\u8f6c\u5316\u4e3aGMP\u8bb0\u5f55\u3002\u4f46\u662f\uff0c\u5982\u679c\u4e00\u4e2a\u7cfb\u7edf\u7684\u76ee\u7684\u662f\u4e3a\u4e00\u9879GMP\u529f\u80fd\u6216GMP\u7ed3\u679c\u63d0\u4f9b\u6587\u4ef6\u5316\u8bc1\u636e\uff0c\u5219\u5176\u5c31\u662fGMP\u7cfb\u7edf\u3002\u4f8b\u5982\uff0c\u5982\u679c\u4e00\u4e2a\u94a5\u5319\u5361\u95e8\u7981\u7cfb\u7edf\u88ab\u7528\u4e8e\u5458\u5de5\u8fdb\u51fa\u4ee5\u5916\u7684\u63a7\u5236\uff0c\u5e76\u4e14\u88ab\u7528\u4f5c\u57f9\u517b\u57fa\u704c\u88c5\u5408\u89c4\u7684\u65e0\u83cc\u4e2d\u5fc3\u91cc\u505c\u7559\u65f6\u95f4\u76d1\u6d4b\u7684\u65e5\u5fd7\uff0c\u5219\u5176\u5c31\u662f\u88ab\u7528\u4e8e\u4e86GMP\u7528\u9014\uff0c\u5e94\u8be5\u5728\u5185\u90e8\u7a0b\u5e8f\u91cc\u6e05\u695a\u5b9a\u4e49\u3002\u4f46\u662f\uff0c\u5982\u679c\u6b64\u7cfb\u7edf\u53ea\u662f\u5076\u5c14\u56de\u987e\u6027\u5730\u4f5c\u4e3aGMP\u8c03\u67e5\u4e00\u90e8\u5206\u8fdb\u884c\u8bc4\u4f30\uff0c\u4ee5\u786e\u4fdd\u5458\u5de5\u5e76\u672a\u5728\u65e0\u83cc\u4e2d\u5fc3\u8d85\u65f6\u505c\u7559\uff0c\u5219\u8be5\u7cfb\u7edf\u5e76\u4e0d\u4e00\u5b9a\u88ab\u8ba4\u4e3a\u662fGMP\u7cfb\u7edf\u3002\u5f53\u7136\uff0c\u8be5\u7cfb\u7edf\u4e2d\u4f5c\u4e3a\u8c03\u67e5\u90e8\u5206\u7684\u6587\u4ef6\u8bb0\u5f55\u5e94\u8be5\u4fdd\u7559\u4f5c\u4e3a\u8c03\u67e5\u7684\u8d44\u6599\u3002<\/span><\/p>\n

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

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END<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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

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\"GMP\u8fce\u68c0\u8981\u4e0a\u5929\u4e48\uff1f\u975eGMP\u5185\u5bb9\u4e5f\u8981\u67e5\uff01\"<\/section>\n<\/section>\n<\/section>\n
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\u6587\u7ae0\u6765\u6e90<\/strong><\/p>\n<\/section>\n

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\u84b2\u516c\u82f1<\/strong><\/p>\n<\/section>\n

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\u514d\u8d23\u58f0\u660e\uff1a\u672c\u6587\u7cfb\u7f51\u7edc\u8f6c\u8f7d\uff0c\u7248\u6743\u5f52\u539f\u4f5c\u8005\u6240\u6709\u3002\u6240\u8f6c\u8f7d\u6587\u7ae0\u5e76\u4e0d\u4ee3\u8868\u672c\u516c\u4f17\u53f7\u8d5e\u540c\u5176\u89c2\u70b9\u548c\u5bf9\u5176\u771f\u5b9e\u6027\u8d1f\u8d23\u3002\u4f46\u56e0\u8f6c\u8f7d\u4f17\u591a\uff0c\u65e0\u6cd5\u786e\u8ba4\u771f\u6b63\u539f\u59cb\u4f5c\u8005\uff0c\u6545\u4ec5\u6807\u660e\u8f6c\u8f7d\u6765\u6e90\u3002\u5982\u6d89\u53ca\u4f5c\u54c1\u7248\u6743\u95ee\u9898\uff0c\u8bf7\u53ca\u65f6\u8054\u7cfb\u6211\u4eec\uff0c\u6211\u4eec\u5c06\u5220\u9664\u5185\u5bb9\u4ee5\u4fdd\u8bc1\u60a8\u7684\u6743\u76ca\uff01<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u8f6c\u53d1\u6b64\u6587\u4ec5\u4e3a\u5b66\u4e60\u4ea4\u6d41\uff0c\u82e5\u65e0\u610f\u4fb5\u72af\u7248\u6743\uff0c\u8bf7\u8054\u7cfb\u5c0f\u7f16\u5220\u9664<\/span><\/p>\n


<\/p>\n

    \u5728\u6301\u7eed\u5de5\u827a\u786e\u8ba4\u4e2d\u5927\u5bb6\u9047\u5230\u7684\u95ee\u9898\uff0c\u8fd9\u91cc\u5c0f\u7f16\u4e3a\u5927\u5bb6\u63a8\u8350\u4e00\u4e2a\u4f1a\u8bae\uff0c\u80fd\u591f\u89e3\u51b3\u60a8\u7684\u7591\u95ee\uff01\uff01\uff01<\/span><\/p>\n<\/h2>\n

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2018\u5e748\u670824\u65e5(\u661f\u671f\u4e94)<\/span><\/strong>9:00-12:00  <\/span><\/strong>1<\/span><\/strong>3<\/span><\/strong>:<\/span><\/strong>3<\/span><\/strong>0-1<\/span><\/strong>6<\/span><\/strong>:<\/span><\/strong>3<\/span><\/strong>0<\/span><\/strong>
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1\uff09\u6301\u7eed\u5de5\u827a\u786e\u8ba4\u6587\u4ef6\u8981\u7d20  <\/span>   <\/span><\/p>\n

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\u4e00\u3001\u4f1a\u8bae\u65f6\u95f4\u5730\u70b9\uff1a<\/span><\/strong> <\/span><\/span><\/p>\n

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\u4e8c\u3001\u53c2\u4f1a\u5bf9\u8c61<\/span><\/strong><\/span><\/p>\n

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\u4e09\u3001\u4f1a\u8bae\u8d39\u7528<\/span><\/strong><\/span><\/p>\n

\u4f1a\u8bae\u8d39\uff1a<\/span>2200\u5143<\/span>\/<\/span>\u4eba\u3002\u4f1a\u8bae\u8d39\u5305\u62ec\uff1a\u4f1a\u8bae\u3001\u7814\u8ba8\u3001\u8d44\u6599\u53ca\u8bba\u6587\u96c6\u3002\u98df\u5bbf\u7edf\u4e00\u5b89\u6392\uff0c\u8d39\u7528\u81ea\u7406\u3002<\/span><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u56db\u3001\u8054\u7cfb\u65b9\u5f0f<\/span> <\/span><\/span><\/strong><\/p>\n

\u8054<\/span> \u7cfb<\/span> \u4eba\uff1a\u6f58\u6613<\/span>      panyi2010@126.com   <\/span><\/span><\/strong><\/p>\n

   \u7535    \u8bdd\uff1a13522766753 \uff08\u5fae\u4fe1\u540c\u53f7\uff09<\/span><\/strong><\/p>\n


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

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