乙肝解毒胶囊的微生物限度检查方法验证

Methodological Validation of Microbial Limit Test Method of Yiganjiedu Capsule

目的:建立乙肝解毒胶囊的微生物限度检查方法。方法:采用2010年版《中国药典》规定的平皿法、培养基稀释法,验证确认所采用的方法是否适合该药品的微生物限度检查。结果:细菌数测定采用培养基稀释法;霉菌及酵母菌数测定采用平皿法;控制菌采用培养基稀释法。5种试验菌的回收率均高于70%。结论:该方法可用于乙肝解毒胶囊的微生物限度限度检查。

Objective To establish a method for the microbial limit test of Yiganjiedu Capsule.Methods The routine method and the dilution method regulated by the Chinese Pharmacopoeia （2010 edition）were adopted.Whether the adopted methods suiting for the microbial limit test of Yiganjiedu Capsule was affirmed by the validation.Results The total bacterial count was performed by a dopting medium dilution method and the total molds and yeasts count adopted the conventional plate -count method.The recovery rates of 5 kinds of test organisms were above 70%.Conclusion This method can be used for the microbial limit test of Yiganjiedu Capsule.