头孢菌素的聚合物分析  

Analysis of polymers of cephalosporins

作　　者：胡昌勤[1] 张夏[1] 李进[1] Hu Chang-qin;Zhang Xia;Li Jin(National Institutes for Food and Drug Control,Beijing 102629)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国抗生素杂志》2022年第3期221-228,共8页Chinese Journal of Antibiotics

摘　　要：头孢菌素是临床中最重要的一类β-内酰胺抗生素,是当前国内仿制药一致性评价的热点品种。鉴于对头孢菌素聚合物类杂质的分析是药物杂质谱控制中的最薄弱环节,而头孢菌素的聚合反应与其3位侧链和7位侧链的结构密切相关,在对7-氨噻肟头孢菌素的聚合物进行了专门讨论的基础上,本文根据头孢菌素7位侧链和3位侧链的特点,回顾近年来对除7-氨噻肟头孢菌素以外的头孢菌素聚合物分析取得的进展,归纳总结它们的聚合反应特性、聚合物特性等,进而形成对头孢菌素聚合物分析的完整策略。Cephalosporin is one of the most important β-lactam antibiotics in clinic, and it is a poplular antibiotics in the generic consistency evaluation in China at present. The control of cephalosporin polymers is the weakest field in the impurity profiling. The polymerization of cephalosporin is closely related to the structures of its C-3and C-7 positions. The progress on analysis of the polymers of 7-aminotaxime cephalosporins in recent years has been reviewed. In this paper, according to the structures of cephalosporins at the C-3 and C-7 positions, the polymerization reaction characteristics and polymer natures of other kinds of cephalosporins were summarized. We hope to form a complete analysis strategy for cephalosporin polymer analysis.

关 键 词：头孢菌素 杂质谱 聚合物 LC-MS 裂解途径 

分 类 号：R978.1[医药卫生—药品]