抗纤软肝胶囊微生物限度检查方法的验证

Verification of methodology on the microbial limit test for Kangxianruangan Capsules

目的:建立抗纤软肝胶囊的微生物限度检查法,并对方法进行验证。方法:细菌计数法为培养基稀释法,霉菌和酵母菌计数法为常规法,控制菌检查为常规法。结果:在2次独立的平行试验中,5株试验菌回收率均大于70%,符合验证要求。结论:该方法消除了样品的抑菌性,可用于该品种的微生物限度检查。

Objective：TO provide a method of the microbial limit test for Kangxianruangan Capsules and carry out verification of the mothod.Method：Culture dilution method was used in bacterium count,while normal method was also used in total mildews and yeasts count,while normal method was used in test for controlled bacteria.Result：In the parallel experiment of 2 independence,5stubs a germ recovery rate all more than 70%.Conclusion：It can eliminate the antimicrobial properties,and it can be used for the microbial limit test for Kangxianruangan Capsules.