注射用头孢尼西钠国内外质量现状分析  

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

作　　者：李雪[1] 洪建文[1] 李佩 Li Xue;Hong Jian-wen;Li Pei(Guangdong Institute for Drug Control,Guangzhou 510030)

机构地区：[1]广东省药品检验所,广州510030

出　　处：《国外医药（抗生素分册）》2020年第6期426-429,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-注射用头孢尼西钠的基本信息、国内外上市情况、参比制剂、国内质量研究、临床使用方法等信息进行了梳理,并对临床使用方法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参考。Cefonicid Sodium is a commonly used β-lactam antibiotics preparation for injection.In this paper,the basic information,the market satiation at home and abroad,Reference List Drug(RLD),domestic quality studies and the method of the clinical use evaluation of Cefonicid sodium for injection were sorted out.The method of the clinical useand quality standards of thepreparations at home and abroad were compared and analyzed,which provided technical information,suggestions for theconsistency evaluation of this variety.

关 键 词：头孢尼西钠 国内外现状 一致性评价 

分 类 号：R978.1[医药卫生—药品]