头孢菌素类抗生素中高分子杂质的研究进展

Research Progress in the High Molecular Weight Impurities of Cephalosporins

头孢菌素类抗生素中的高分子杂质是引发速发型过敏反应的过敏原,是药物分析研究的重点。高分子杂质分为外源性杂质和内源性杂质,目前内源性聚合物是药物质量控制的重点。本文对近年来头孢菌素中高分子杂质的聚合特性、结构特点和分离分析方法研究进行了综述。

The high molecular weight impurities in cephalosporins are the sensibilisinogen causing tacho-anaphylactic reaction and the emphasis in pharmaceutical analytical studies. These impurities include endogenic impurities and exogene impurities, and the former are the focal point of quality control. This review mainly focuses on the research progress of high molecular weight impurities of cephalosporins in recent years, including polymers＇ characteristics, chemical structure, as well as the seoarating and analvtical methods.