培南类抗菌药质量控制方法的研究进展  

Progress on Quality Control of Penem Antibiotics

作　　者：罗文燕 丁颖[2] 秦峰[2] 刘浩[2] LUO Wenyan;DING Ying;QIN Feng;LIU Hao(China State Institute of Pharmaceutical Industry,Shanghai 201203;Shanghai Institute for Food and Drug Control,Shanghai 201203)

机构地区：[1]中国医药工业研究总院,上海201203 [2]上海市食品药品检验所,上海201203

出　　处：《中国医药工业杂志》2021年第1期42-55,共14页Chinese Journal of Pharmaceuticals

摘　　要：培南类抗菌药具有抗菌谱广、抗菌活性强等特点,用于多重耐药菌及重症感染的治疗。为了加强药物的安全性和有效性,本文主要综述了培南类抗菌药质量研究方面的进展,介绍了培南类抗菌药的结构特点,以及含量、有关物质、聚合物杂质和金属杂质等的检测方法,为培南类抗菌药的质量控制提供参考与借鉴。Penem antibiotics have broad antibacterial spectrum and strong antibacterial activity,which are used for the treatment of multi-drug resistant bacteria infections.In order to strengthen the safety and effectiveness of the drugs,the progress in the quality research was reviewed in the paper,including assay,detection of the related substances,polymers and metal impurities,providing some references for quality control of penem antibiotics.

关 键 词：培南类抗菌药 结构特点 有关物质 质量控制 

分 类 号：R917[医药卫生—药物分析学] R927[医药卫生—药学]