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.
出处
《中国药品标准》
CAS
2005年第3期20-29,共10页
Drug Standards of China
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
microbial limits,total bacterial count,total combined molds and yeasts count,enterobacteriaceal,enterobacterial
