浅析USP 31版微生物限度标准  

Simple analysis about microbial limit criteria in USP 31

作　　者：马仕洪[1] 胡昌勤[1] 苏德模[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《药物分析杂志》2009年第10期1752-1761,共10页Chinese Journal of Pharmaceutical Analysis

摘　　要：本文就USP31版收载微生物限度的品种分类列表,并进行系统分析。USP31版微生物限度检查的一般要求与品种项下的微生物限度要求不完全相关;总的趋势是微生物检查方法和控制微生物的品种在不断增加,对药品微生物质量控制的要求更高;微生物限度的编写格式和细菌数的分级不拘一格。这些变化可为中国药典的修订和发展提供参考。We list the classification of the limits of the microbial species which are contained in USP 31 and carry out a systematic analysis of them. The increasing method of pharmacopoeia microbial examination are not completely correlative with the demand of microbial limits criteria. The general trend is that the method of microbiological ex- amination and the controlled microbial species are growing and the demand of pharmaceutical is higher. The format of microbial limits and bacteria levels are in several kinds. These changes are only reference to amendments and development of Chinese Pharmacopoeia.

关 键 词：USP31 微生物限度检查 微生物限度标准 

分 类 号：R917[医药卫生—药物分析学]