注射用头孢唑林钠国内外质量现状分析  

Analysis on the Quality of Cefazolin Sodium for Injection at Home and Abroad

作　　者：武建卓[1] 肖慧[1] 洪建文[1] Wu Jian-zhuo;Xiao Hui;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416-419,共4页World Notes on Antibiotics

摘　　要：本文对常用β-内酰胺类注射用抗生素制剂-注射用头孢唑林钠的基本信息、国内外上市情况、参比制剂、质量研究等信息进行了梳理,结合国家评价性抽验及产品质量检测情况,对产品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。Cefazolin sodium is a commonly used β-lactam antibiotics preparation for injection.This article reviewed the basic information,the situation of listing at home and abroad,reference preparation,quality studies of Cefazolin sodium for injection and compared,combined with the experience of national quality evaluation and the product quality inspection of postmarketing drugs,and analyzed the preparation technology,quality standards of the preparations at home and abroad,provided technical information,suggestions for the consistency evaluation of this variety.

关 键 词：头孢唑林钠 国内外现状 一致性评价 

分 类 号：R978.1[医药卫生—药品]