三黄消渴片微生物限度检查方法验证探讨  

Validation method of microbial limits of Sanhuangxiaoke pill

作　　者：薛洁[1] 闫柏琴[1] 韩荣[1] 曹燕玲 

机构地区：[1]新疆医科大学附属中医医院,乌鲁木齐830000 [2]新疆维吾尔自治区药品检验所,乌鲁木齐830002

出　　处：《中华中医药杂志》2008年第8期727-728,共2页China Journal of Traditional Chinese Medicine and Pharmacy

摘　　要：目的:建立三黄消渴片微生物限度检查方法。方法:按中国药典2005版规定采用5种阳性对照菌回收率试验测定其是否含抑菌成分。结果:按供试品制备方法,各试验菌样品中的回收率均达到70%以上。结论:三黄消渴片所采用的检验方法可以消除药品的抑菌作用,可以有效地检出污染的微生物,使测定结果准确,药品质量安全有效,达到验证实验的目的。Objective： To establish the validation method of microbial limits of Sanhuangxiaoke pill. Methods： According to the People＇s Republic of China Pharmacopoeia, recovery rate with 5 positive control trains were used to determine the antimicrobial effect. Results： According to the results, the recovery rates were higher than 70% by preparation of sample. Conclusion： Sanhuangxiaoke pill preparations can elimination the bacteriostatic action with accurate result and reach the objective.

关 键 词：微生物限度方法验证 回收率 药品质量 

分 类 号：R286.0[医药卫生—中药学]