蛹虫草菌粉胶囊微生物限度检查方法学验证试验

Validation of microbial limit tests for Yongchongcaojunfen capsules

目的完善蛹虫草菌粉胶囊的微生物限度检验方法。方法据《中国药典》2010年版微生物限度检查法,分别采用常规法、培养基稀释法对蛹虫草菌粉胶囊进行微生物限度检查验证。结果采用培养基稀释法对蛹虫草菌粉胶囊进行微生物限度检查,回收率>70%,表明其能充分消除药品中的抑菌作用。结论培养基稀释法可作为蛹虫草菌粉胶囊的常规微生物限度检查方法。

Objective To perfect the microbial limit tests for Yongchongcaojunfen capsules. Methods Microbial limit tests for Yongchongcaojunfen capsules were validated with the conventional and medium dilution methods in Chinese Pharmacopoeia （2010 edition）. Results The recovery rate of microbial limit test was 70% for Yongchongcaojunfen capsules, indicating that it could fully eliminate the inhibitory effect of the drugs. Conclusion Medium dilution method can be used as a microbial limit test for Yongchongcaojunfen capsules.