富马酸二甲酯肠溶胶囊微生物限度方法学的研究  

Methodology validation of Microbial Limit Test for Dimethylfumarate enteric-coated capsules

作　　者：张光华[1] 李玉立[1] 牛振东[1] 刘文杰[1] 江志杰[1] ZHANG Guanghua;LI Yuli;NIU Zhendong;LIU Wenjie;JIANG Zhijie(Beijing Institute for Drug Control,NMPA Key Laboratory for Research and Evaluation of Generic Drugs,Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,Beijing 102206,China)

机构地区：[1]北京市药品检验所国家药品监督管理局仿制药研究与评价重点实验室中药成分分析与生物评价北京市重点实验室,102206

出　　处：《首都食品与医药》2020年第10期198-200,共3页Capital Food Medicine

摘　　要：目的建立富马酸二甲酯肠溶胶囊的微生物限度检查方法,探讨使用多种检验方法联用检测富马酸二甲酯肠溶胶囊的微生物限度。方法按照《中华人民共和国药典》2015年版通则1105、1106、1107,采用稀释法、萃取法、中和法及薄膜过滤法联用对富马酸二甲酯肠溶胶囊进行微生物限度检查方法适用性试验,消除了药品的抑菌性。结果采用稀释法、萃取法、中和法及薄膜过滤法联用,微生物计数验证菌的回收比值均在0.5~2.0范围内,控制菌检查阳性对照菌生长良好。结论采用稀释法、萃取法、中和法和薄膜过滤法联用对富马酸二甲酯肠溶胶囊进行微生物限度检查,准确可行,可用于产品的质量控制。Objective To establish a microbiological limit test method for Dimethylfumarate enteric-coated capsules,and investigate the microbiological limit test method using a combination of test methods.Methods According to the General Chapters 1105,1106 and 1107 of volumeⅣof Chinese Pharmacopoeia(Edition 2015),the dilution method,extraction method,neutralization method and membrane filtration method are used for Dimethylfumarate enteric-coated capsules.The methodology validation of microbial limit test is carried out to eliminate the antibacterial activity of the drug.Results Dilution method,extraction method,neutralization method and membrane filtration method were used in combination.The counting recovery ratio of each test bacterium was in the range of 0.5~2.0.The validation test for specified microorganisms was positive.Conclusion The modified method was applicable to the microbial limit test of Dimethylfumarate enteric-coated capsules.It can be used for quality control of products.

关 键 词：富马酸二甲酯肠溶胶囊 微生物限度 方法适用性试验 中和法 萃取法 薄膜过滤法 

分 类 号：R917[医药卫生—药物分析学]