肾宁合剂微生物限度检查方法的验证  

Validation of microbial limit tests of Shenning mixture

作　　者：曾云胜[1] 张先洲[2] 

机构地区：[1]湖北省仙桃市第一人民医院药剂科,湖北仙桃433000 [2]武汉大学人民医院药学部,湖北武汉430060

出　　处：《中国当代医药》2013年第17期78-79,共2页China Modern Medicine

基　　金：湖北省科技攻关课题(编号2006AA301C02)

摘　　要：目的验证肾宁合剂微生物限度检查方法。方法测定肾宁合剂中5种试验菌的回收率,以大肠埃希菌作为控制菌,金黄色葡萄球菌作为阴性对照菌,考察控制菌检查的专属性。结果 5种试验菌的回收率均达到70%以上,细菌、真菌及酵母菌数测定均可采用常规法进行检验。结论肾宁合剂的微生物限度检查方法可行,能有效控制该制剂质量。Objective To verify the method of microbial limit test in Shenning mixture. Methods The recoveries of 5 kinds of test bacteria in Shenning mixture were determined, the specificity of control bacteria was investigated with Escherichia coli as control bacteria and Staphylococcus aureus as negative bacteria. Results The recoveries of 5 kinds of test bacteria in Shenning mixture were all over 70% and conventional method for determination of bacteria, mold and yeast count were applied. Conclusion The method of microbial limit test of Shenning mixture is feasible, and can effectively control the quality of preparation.

关 键 词：肾宁合剂 微生物限度检查 验证 大肠埃希菌 

分 类 号：R927[医药卫生—药学]