金莲清热颗粒微生物限度检查法验证  

Validation Of Method For Microbial Limit Test of Jinlian Qingre Keli

作　　者：刘淑娟 冯梅 

机构地区：[1]宁夏唐明制药有限公司,银川750010

出　　处：《北方药学》2014年第10期10-11,共2页Journal of North Pharmacy

摘　　要：目的:建立经过验证的金莲清热颗粒的微生物限度检查。方法:对金莲清热颗粒的抑菌活性及测定方法的可靠性进行验证。现依据《中国药典》(2010年版)一部微生物限度的检查方法对金莲清热颗粒进行微生物验证。结果:5株阳性菌的回收率均可达到70%以上。结论:可按培养基稀释法对金莲清热颗粒进行微生物限度检查。Objective：Lily heat particles that is intended to establish a proven method of microbial limit test, the antibacterial activity of Jinlian qingre granules and determination of the reliability of authentication.Methods The validation test for microbial limit examination of Jinlian Qingre Keli was according to the method of Chinese Pharmacopoeia.Results The recovery iS over 70%in 5 positive strains by the method of culture dish.Conclusion The validation method of Jinlian Qingre Keli for microbiallimit should use medium dilution method.

关 键 词：金莲清热颗粒 微生物限度检查 培养基稀释法 抑菌性 

分 类 号：R927.1[医药卫生—药学]