活骨胶囊的微生物限度检查方法学验证研究  

A Validation Method Used for Microbial Limit Test of Huogu Capsules

作　　者：周尚[1] 高锦 聂渝琼 张润婕 付晓菲 

机构地区：[1]总后勤部卫生部药品仪器检验所,北京100071 [2]不详

出　　处：《解放军药学学报》2009年第3期268-270,共3页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的建立活骨胶囊的微生物限度检验方法。方法按《中国药典》2005年版规定,分别采用常规法、培养基稀释法、离心加薄膜过滤法对样品进行微生物限度检查。根据5株阳性对照菌的回收率结果进行其方法学验证试验研究。结果活骨胶囊含有药材原粉,并且具有抑菌活性,离心加薄膜过滤法能有效的去除其抑菌活性。结论用该法进行微生物限度检查,可以客观地反映药物中微生物的污染状况,可达到检测目的。Aim To establish a method to determine the microbial limit viable count tests for Huogu Capsules. Methods In line with the Chinese Pharmacopoeia 2005 edition, three testing methods were used, yielding differentpercentage recovery with 5 controls trains. Results Huogu Capsules had crude Tradional Chinese Medicine（TCM） and antimicrobial effects, which could be e.liminated by centrifugation and membrane filtration. Conclusion This method ,feasible and accurate, can be used for testing.

关 键 词：微生物限度检查 离心加薄膜过滤法 活骨胶囊 

分 类 号：R917[医药卫生—药物分析学]