四种中成药微生物限度检查方法验证

目的建立四种中成药的微生物限度检查方法。方法采用《中国药典》2010年版一部规定的常规法,培养基稀释法进行菌回收率比较试验。结果四种药品在常规法检测金黄色葡萄球菌回收率均低于70%。采用培养基稀释法,其菌回收率均大于70%。结论四种中成药的微生物限度检查应采用培养基稀释法检测才能得到满意的结果。

Determination and Validation of Four Chinese Patent Medicines by Microorganism Limited Method

Objective To establish the determination method for four kinds of Chinese patent medicines by microorganism limited method. Methods The comparative experiments of bacterium recovery rate were adopted to compare the common method in Chinese Pharmacopoeia （2010） with the culture medium dilution method. Results The recovery rate of golden staphylococcus in four kinds of medicines is less than 70% by common examination method＇, while it is more than 80% when adopting culture medium dilution method. Conclusion The satisfactory results should be gained by culture medium dilution method through the microorganism limited check for the four Chinese Patent medicines.