Objective To establish a method for microbial limit test of Ganyu capsules. Methods The method for microbial limit examination in Chinese Pharmacopoeia was followed. The validation had been tested by recovery. Results With direct inoculation method and medium diluted method(0.5 mL/dish),the rations of all test microbial group were lower than 70%.With medium diluted method(0.1 mL/dish),the rations of Aspergillus nigers and Candida albicans were higher than 70%.With filtration membrane ,all the ratios were higher than 70%. Conclusion In this validation of method for microbial limit should use filtration membrane method, the mould (yeast) and the controls bacterium should use direct inoculation method.%目的 建立感愈胶囊微生物限度检查法.方法 按<中国药典>现行版规定的方法试验,以回收率对方法的有效性进行评价.结果 采用直接接种法和培养基稀释法(0.5mL/皿),5种阳性菌回收率均<70%;采用培养基稀释法(0.1 mL/皿),黑曲霉菌和白色念珠菌回收率70%;采用薄膜过滤法,3种阳性菌回收率均70%.结论 本品微生物限度检查法中细菌检查应采用薄膜过滤法,霉菌(酵母菌)检查和控制菌检查应采用直接接种法.
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