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

作　　者：吴伟平 陈宇堃[1] 梁蔚阳[1] 余燕[1] WU Weiping;CHEN Yukun;LIANG Weiyang;YU Yan(Guangdong institute for Drug Control,Guangdong Food and Drug Administration Key Laboratory of Quality Control and Risk Assessment of Blood Products,Guangzhou 510663,China)

机构地区：[1]广东省药品检验所,广东省食品药品监督管理局血液制品质量控制与风险监测重点实验室,广州510663

出　　处：《中国药品标准》2020年第2期130-134,共5页Drug Standards of China

基　　金：广东省医学科研基金(B2018130);广州市科技计划项目(201804010251);广东省食品药品管理局科技项目引导扶持基金(2018YDB02)。

摘　　要：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.

关 键 词：他克莫司胶囊 微生物限度检查法 薄膜过滤法 

分 类 号：R921.2[医药卫生—药学]