保和丸(水丸)微生物限度检查法验证

Validation Of Method For Microbial Limit Test of Baohe Wan

目的:建立保和丸(水丸)的微生物检查方法。方法:按照《中华人民共和国药典》(2010)一部微生物限度检查方法对保和丸(水丸)进行微生物验证。结果:5株阳性菌的回收率均可达到75%以上。结论:可按平皿法对保和丸(水丸)进行微生物限度检查。

Objective：To＇establish a method for microbial limit test of Baohe Wan.Methods：The validation test for microbial limit examination of Baohe Wan was according to the method of Chinese Pharmacopoeia.Results：The recovery is over 75% in 5 positive strains by the method of culture dish.Conelusion： The validation method of Baohe Wan for microbiallimit should use culture dish method.