仙阳壮肾胶囊微生物限度检查的方法学验证

Verification of Methodology on Microbial Limit Test for Xianyang Zhuangshen Capsule

目的:建立仙阳壮肾胶囊的微生物限度检查方法。方法:采用直接接种法和培养基稀释法测定仙阳壮肾胶囊对验证菌株的回收率,并对控制菌检查法进行验证。结果:仙阳壮肾胶囊以直接接种法检查大肠埃希菌、金黄色葡萄球菌、黑曲霉菌的菌回收率>70%,采用培养基稀释法检查枯草芽胞杆菌、白色念珠菌的菌回收率>70%。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 establish a method for the microbial limit test of Xianyang Zhuangshen capsule.Method： Verified by the experiment with directly inoculated and culture diluting method,and measured the percentage recovery of bacterium.Result： The medicine had no antimicrobial effect with Escherichia coli,Staphylococcus aureus and Aspergillus niger.The medium dilution method can e1iminate restraining effect of Candida albicans and Bacillus subtilis.Conclusion： It can eliminate the antimicrobial properties,and it can be used for the microbial limit test for Xianyang Zhuangshen capsule.