舒郁胶囊微生物限度检查的方法学验证研究  

Validation Method Used for Microbial Limit Test of Shuyu Capsules

作　　者：白林[1] 陈利平[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》2009年第21期2835-2836,共2页Chinese Journal of Nosocomiology

摘　　要：目的建立舒郁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。结果舒郁胶囊具有抑菌活性,培养基稀释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,以达到检测目的。OBJECTIVE To establish the method to determine the microbial limit tests for Shuyu Capsules. METHODS According to the Chinese Pharmacopoeia 2005 edition, two testing methods had different percentage recovery with 5 control trains. RESULTS Shuyu Capsules were Tradional Chinese Medicine （TCM）,and that had antimicrobial effects, which could be eliminated by media dilution method. CONCLUSIONS This method can achieve the destination which is feasible and accurate.

关 键 词：微生物限度检查 培养基稀释法 舒郁胶囊 

分 类 号：R378[医药卫生—病原生物学]