美英欧药典微生物限度标准的浅析  

Simple Analyse about Microbial Limits in USP,BP and EUP

作　　者：苏德模[1] 胡昌勤[1] 马越[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《中国药品标准》2005年第3期20-29,共10页Drug Standards of China

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。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.

关 键 词：美国 英国 欧洲 药典 微生物 限度标准 肠道菌 生物限度 

分 类 号：R95[医药卫生—药学]