支扩宁合剂微生物限度检查方法学验证  

Validation method for the microbial limit test of zhikuoning mixture

作　　者：达庆国[1] 陈晓斌[1] 周琴妹[1] 

机构地区：[1]江苏省中医院,江苏南京210029

出　　处：《安徽医药》2009年第11期1339-1341,共3页Anhui Medical and Pharmaceutical Journal

基　　金：江苏省科学技术厅社会发展项目(NoBS2002062)

摘　　要：目的对支扩宁合剂微生物限度检查法进行方法学验证。方法《中国药典》2005年版一部附录XⅢ C微生物限度检查法。结果5种试验菌的回收率均高于70%,试验组检出控制菌,阴性菌对照未检出。结论采用常规法可进行本品微生物限度检查。Aim To validate the microbial limit test（MLT） of zhikuoning mixture.Methods The examination method for MLT at Appendix（XⅢ C） of China Pharmacopoeia was adopted.Results The recovery rate of five tested bacteria were higher than 70%.The control bacterium were detected in the test group and negative bacteria was not detected in the control group.Conclusion The MLT of zhikuoning mixture is feasible by routine method.

关 键 词：支扩宁合剂 微生物限度检查法 方法验证 

分 类 号：R286.0[医药卫生—中药学]