3种中成药微生物限度检查的方法验证

目的建立合适的微生物限度检查方法,对银黄颗粒、清喉利咽颗粒、柴黄颗粒3种中成药的微生物限度检查方法进行验证。方法采用中国药典2005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3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,金黄色葡萄球菌回收率均>70%。符合验证要求。结论3种中成药在常规法检测时均有一定的抑菌作用。3种中成药的微生物限度检查应采用培养基稀释法检测才得到满意的结果。

Valid methods of microorganism limited check for 3 Chinese potent medicine

Objective To establish the limited check method for microorganism and to inspect whether the method for 3 Chinese potent drugs is valid.Methods Common methods in Chinese Pharmacopoeia(edition 2005) were used to cultivate culture media dilution,using recovery rate of the bacteria in the comparison experiment.Results The recovery rate of golden staphylococcus in the 3 medicines by common methods was less than 70%,while it was larger than 70% through cultivating culture media dilution method.Conclusion The three Chinese Potent drugs had the effect of restraining bacteria,when checked by common ways.Microorganism limited check for the three Chinese potent medicines should adopt culture media dilution method.