清肝解毒胶囊微生物限度检查方法验证

MICROBIAL LIMIT TEST VALIDATION BY IN QINGGAN JIEDU CAPSULE

目的建立清肝解毒胶囊的微生物限度检查方法。方法按照《中国药典》2010年版一部附录XIII C"微生物限度检查法"对清肝解毒胶囊进行微生物验证试验。结果采用平皿法大肠埃希菌、金黄色葡萄球菌、枯草芽孢杆菌、白色念珠菌、黑曲霉的回收率均达到70%以上。结论清肝解毒胶囊的微生物限度检查方法为细菌,霉菌、酵母菌计数采用平皿法,控制菌检查采用常规法。

Objective To establish a method for microbial limit test of Qinggan jiedu capsule. Methods Based on ＂Chinese Pharmacopoeia＂ 2010 edition 1 Appendix XIII C ＂Microbial Limit Test＂ to verify Qinggan jiedu capsule. Results The recovery of Escherichia coli,Staphylococcus aureus,Bacillus subtilis,Candida albicans,and Aspergillus niger are reached at average more than 70% by using Plate method. Conclusion The validation method of Qinggan jiedu capsule for microbial limit should use plate methods,conventional methods can be used to the inspection method of bacteria control.