芪参清幽胶囊微生物限度检查方法验证

Research on the Method Validation of Microbial Limit Test for Qishenqingyou Capsules

目的:建立芪参清幽胶囊微生物限度检查方法。方法:按《中国药典》(2010年版)的规定,进行该品种微生物限度检查方法的验证。结果:常规法试验芪参清幽胶囊对枯草芽孢杆菌、金黄色葡萄球菌均有抗菌作用,回收率小于70%;培养基稀释法可消除本品对上述2种菌株的抗菌作用,回收率大于70%;常规法试验能检出大肠埃希菌。结论:本品可用常规法进行霉菌和酵母菌数测定;可用培养基稀释法进行细菌测定;可用常规法进行控制检验。

Objective：To establish a method of microbial limit test for qishenqingyou capsules . Methods：Ac-cording to the Chinese Pharmacopoeia of 2010 edition , the method validation of microbial limit test on qishenqingy-ou capsules was conducted . Results： By using the conventional test methods , the antibacterial actions of qishen-qingyou capsules were showed for Bacillus subtilis and Staphylococcus aureus , and the recovery rate was less than 70%. The culture medium dilution method could eliminate the antibacterial activity of the product for the above two strains , and the recovery rate was greater than 70%. The conventional test methods can detect Escherichia coli in the product . Conclusion：For the product , the conventional test methods can be used for the bacterial counting test of mould or yeast and the control tests of bacteria , and the dilution method can be used for determination of bacte-ria .