残黄片微生物限度检查方法的建立及验证  

The Establishment and Validation of Microbial Limit Tests of Canhuang Tablets

作　　者：张诗龙[1] 周燕萍[1] 韩晋[1] 刘峰群[1] 袁海龙[1] 谢进[1] 

机构地区：[1]解放军302医院药学部,北京100039

出　　处：《解放军医药杂志》2012年第11期33-36,共4页Medical & Pharmaceutical Journal of Chinese People’s Liberation Army

基　　金：北京市中医药管理局"十病十药"入选项目(SBXY2012-005)

摘　　要：目的建立残黄片的微生物限度检查方法并进行验证。方法对残黄片采用培养基稀释法进行细菌计数,采用常规法进行真菌和酵母菌计数、大肠埃希菌、大肠菌群检查。结果在3次独立的平行试验中,5株试验菌回收率均>70%,控制菌均能正常检出,符合验证要求。结论本方法简便可行,结果准确,适用于残黄片的微生物限度检查及其质量控制。Objective To establish and validate the method of microbial limit test of Canhuang tablets. Methods Culture media dilution method was used for bacterial count, and routine method was used for total combined molds and yeasts count, detection of escherichia coli and coliform bacteria. Results Coefficient of recovery of five test organisms were all over 70% in the three independence parallel experiments. Conclusion The method is simple and veracious for microbial limit tests and quality control of Canhuang tablets.

关 键 词：残黄片 微生物限度检查 方法验证 

分 类 号：R927.11[医药卫生—药学]