他克莫司胶囊微生物限度检查方法的建立

Establishment of the microbial limit verification test of tacrolimus capsules

目的:建立他克莫司胶囊微生物限度检查方法。方法:参照《中国药典》(2015版)、《药品微生物检验手册》和《中国药品检验标准操作规范》(2010版)收载的微生物限度检验方法,建立他克莫司胶囊微生物限度检查方法。结果:实验证明采用薄膜过滤法对他克莫司胶囊进行微生物限度检查,能有效检出该药品中污染存活的细菌,检测后回收比值均在0.5~2范围内。结论:建立了适用于他克莫司胶囊微生物限度检验的薄膜过滤法,该法能有效地滤除药品中抑菌物质的干扰,其检出率高。

Objective:To establish the method of microbial limit test for tacrolimus capsules.Methods:The microbial limit verification test of tacrolimus capsules was established according to ChP 2015,Microbial Inspection Manual of Drugs and Standard Operation of Chinese Drug Inspection 2010.Results:The microbial limit verification test on tacrolimus capsules through membrane filtration method was carried out with the recovery rate between 0.5 and 2,which was proved to effectively detect the bacteria within the drugs.Conclusion:Microbial limit verification test of tacrolimus capsules through membrane filtration method was established with high detection rate,which can avoid antibacterial interference effectively.