摘要
目的:探讨补中益肾丸微生物限度的研究。方法:按《中国药典》2005年版一部的规定,使用常规法对样品进行验证,测定5种代表菌株的回收率,来确定微生物限度验证的检验方法。结果:补中益肾丸对细菌、霉菌和酵母菌的抑制作用不大,故采用常规法即可进行该项全面检查。结论:参照有关文献建立了补中益肾丸微生物限度检查法,并对其进行了方法学验证。
Objective：To fill in the microbial limit Yishcn study pills. Methods：According to ＂Chinese Pharmacopoeia＂ version of a 2005 requirement, the use of conventional method of validation samples, the determination on behalf of five kinds of strain rate, to determine the microbial limit test method validation. Results：Pill Yishen fill in bacteria, mold and yeast inhibition did not, they used the conventional method which can be carried out comprehensive inspection. Condusion：Yishen Pill fill in the light of the relevant literature to establish the microbial limit test and validate a methodology.
出处
《中国当代医药》
2009年第17期14-16,共3页
China Modern Medicine
关键词
补中益肾丸
微生物限度
常规法
验证
Fill in Yishen pills
Microbial limit
Conventional method
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