硫柳汞醇溶液微生物限度检查的方法学验证研究  

Methodological validation of microbial limit test with thiomersal alcoholic solution

作　　者：白林[1] 郭代红[1] 高翠萍[1] 

机构地区：[1]解放军总医院药检室,北京100853

出　　处：《中华医院感染学杂志》2012年第24期5676-5677,共2页Chinese Journal of Nosocomiology

摘　　要：目的建立硫柳汞醇溶液的微生物限度检验方法。方法按《中国药典》2010年版规定,分别采用培养基稀释法、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。结果硫柳汞醇溶液具有抑菌活性,培养基稀释法回收率<70.0%;薄膜过滤法各菌回收率>78.0%,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,以达到检测目的。OBJECTIVE To establish the method to determine the microbial limit viable count tests with thiomersal alcoholic solution.METHODS According to the ＂Chinese Pharmacopoeia＂ 2010 edition,the medium dilution method and membrane filtration method were employed to perform the microbial limit test;according to the 5 positive control strains in the study group,the bacteria broth group,and the test sample group,the methodological validation test was studied.RESULTS Thiomersal alcoholic solution had antimicrobial activity,the recovery rate of medium dilution method was less than 70.0%;the recovery rate of membrane filtration method was higher than 78.0%,which could effective eliminate the antibacterial activity.CONCLUSION The thiomersal alcoholic solution can be used for the microbial limit test,which can directly reflect the condition of the bacterial contamination of drugs so as to achieve the purpose of test.

关 键 词：硫柳汞醇溶液 微生物限度检查 薄膜过滤法 

分 类 号：R446[医药卫生—诊断学]