注射用头孢孟多酯钠国内外现状比较分析  

Compare and Analysis of the Situation of Cefamandole Nafate for Injectionat Home and Abroad

作　　者：王婷婷[1] 洪建文[1] Wang Ting-ting;Hong Jian-wen(Guangdong Institute for Drug Control,NMPA Key Laboratory for Rapid Testing Technogy of Drugs,Guangzhou 510663)

机构地区：[1]广东省药品检验所,国家药品监督管理局药品快速检验技术重点实验室,广州510663

出　　处：《国外医药（抗生素分册）》2020年第6期420-425,共6页World Notes on Antibiotics

基　　金：“重大新药创制”科技重大专项课题(No.2017ZX09101001-007)。

摘　　要：本文对常用β-内酰胺类注射剂——注射用头孢孟多酯钠的基本信息、国内外上市情况、参比制剂、及国家评价性抽验中国内质量研究等信息进行了梳理,并对国内外制剂的处方工艺和质量标准等进行了分析比较,为该品种的仿制药质量与疗效一致性评价工作提供技术信息、意见和建议。This article reviewed the basic information,themarket satiationat home and abroad,reference preparations and the domestic quality studies fromnational quality evaluationof cefamandolenafate for injection,the commonly used β-lactam antibiotics compared and analyzed the formulation technology,quality standards of the preparations at home and abroad,provided technical information,suggestions for the consistency evaluation of thisvariety.

关 键 词：头孢孟多酯钠 国内外现状 一致性评价 

分 类 号：R978.1[医药卫生—药品]