| 美英欧药典微生物限度标准的浅析 |
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| 引用本文： | 苏德模,胡昌勤,马越. 美英欧药典微生物限度标准的浅析[J]. 中国药品标准, 2005, 6(3): 20-29 |
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| 作者姓名： | 苏德模 胡昌勤 马越 |
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| 作者单位： | 中国药品生物制品检定所,北京,100050 |
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| 摘 要： | 本文就USP,BP和EuP收载的微生物限度分类列表,并进行了系统的对比分析.前者品种项下的微生物限度分级有11级,是否必要?后者微生物限度分级有5级,更适用.指出ChP微生物限度存在的差距,为药典修订和发展提供依据.
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| 关 键 词： | 微生物限度 细菌数 霉菌数和酵母菌数 肠杆菌科 肠道菌 |
Simple Analyse about Microbial Limits in USP, BP and EUP |
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| Su Demo,Hu Changqin and Ma Yue. Simple Analyse about Microbial Limits in USP, BP and EUP[J]. , 2005, 6(3): 20-29 |
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| Authors: | Su Demo Hu Changqin Ma Yue |
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| Affiliation: | National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050;National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050;National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050 |
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| Abstract: | In this paper,the microbial limits recorded in the USP,BP and EuP were classified,listed,and analyzed systematically.There are 11 classes of the microbial limits in the former,is it necessary?There are 5 classes of the microbial limits in the latter,which is proper.It would provide a basis for ChP's revision and development if the obvious difference for microbial limits recorded in ChP was pointed out. |
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| Keywords: | microbial limits total bacterial count total combined molds and yeasts count enterobacteriaceal enterobacterial |
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