参龙健脑胶囊微生物限度检查的方法学验证研究  

Methodology of microbial limit test for Shenlongjiannao capsules:a validation study

作　　者：白林[1] 王发渭[2] 高翠萍[1] 杨帆[1] 

机构地区：[1]解放军总医院药检室,北京100853 [2]解放军总医院中医科,北京100853

出　　处：《中华医院感染学杂志》2011年第18期3969-3970,共2页Chinese Journal of Nosocomiology

摘　　要：目的建立参龙健脑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、离心加薄膜过滤法对样品进行微生物限度检查,根据5株阳性对照菌的试验组、菌液组、供试品对照组的结果进行其方法学验证试验研究。结果参龙健脑胶囊具有抑菌活性,离心加薄膜过滤法能有效地去除其抑菌活性。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,以达到检测目的。OBJECTIVE To establish the method to determine the microbial limit viable count tests for Shenlongjiannao capsules.METHODS According to the Chinese Pharmacopoeia 2005 edition,microbial limit tests were performed by respectively use routine method and centrifugation and membrane method.The results of 5 positive control strains in study group,bacilli group and samples supply for test group were analyzed.RESULTS Shenlongjiannao capsules had antibacterial activity,centrifugation and membrane filtration method could effectively eliminate the antibacterial activity.CONCLUSION This method which objectively reflect the microbial contamination of antibiotics,can achieve the destination of test.

关 键 词：微生物限度检查 离心加薄膜过滤法 参龙健脑胶囊 

分 类 号：R446[医药卫生—诊断学]