摘要
目的建立黄元胶囊的微生物限度检查法。方法按《中国药典》2010版规定,采用5株阳性对照菌回收率试验进行其方法学验证研究。结果黄元胶囊具有抑菌活性,培养基稀释法能有效的去除其抑菌活性。结论黄元胶囊细菌计数采用培养基稀释法进行检测,霉菌、酵母菌和控制菌检查按常规法进行。
OBJECTIVE To establish a method for microbial limit test of HuangYuan capsules. METHODS The 5 control strains recovery test validation method was used as described in the Chinese Pharmacopoeia 2010 edi- tion. RESULTS The medicine had some antimicrobial effect which can be eliminated by the culture medium dilu- tion method. CONCLUSION The results suggested that culture medium dilution method could be used for counting bacteria,while the conventional method could be used common method for counting fungi and for detecting Esche- richia coli.
出处
《海峡药学》
2013年第10期68-70,共3页
Strait Pharmaceutical Journal
关键词
黄元胶囊
微生物限度
培养基稀释法
HuangYuan capsules
Microbial limit test
Culture medium dilution method
