头孢菌素类抗生素聚合物杂质研究进展  

Research progress on polymer impurities of cephalosporin antibiotics

作　　者：符雅楠 李进[1] 尹利辉[1] 冯芳[2] 姚尚辰[1] 许明哲[1] Fu Ya-nan;Li Jin;Yin Li-hui;Feng Fang;Yao Shang-chen;Xu Ming-zhe(National Institutes for Food and Drug Control,Beijing 102629;China Pharmaceutical University,Nanjing 211198)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]中国药科大学,南京211198

出　　处：《中国抗生素杂志》2022年第2期114-121,共8页Chinese Journal of Antibiotics

基　　金：中国食品药品检定研究院化药所重点实验室课题“抗生素药物杂质分析技术平台的建立与应用”(No.1030050090129)。

摘　　要：内酰胺类抗生素中的聚合物杂质易诱发过敏反应,在临床用药过程中时有发生,甚至威胁到患者的健康和生命。随着分离技术的快速发展、人们对聚合物杂质结构、反应机理等认识进一步加深,聚合物杂质的质控理论也已由总量控制发展为对指针性聚合物杂质进行精准控制。本文综述了近年来该领域的发展,探讨了头孢菌素类抗生素聚合物杂质质控的分析方法、结构研究等趋势及进展,提出了仍需进一步思考和研究的问题。Polymer impurities in β-lactam antibiotics are prone to induce allergic reactions, which occur from time to time in the process of clinical medication and threaten the health and life of patients. With the rapid development of separation technology and the deepening understanding of the structure and reaction mechanism of polymer impurities, the quality control theory of polymer impurities has also been developed from total amount control to accurate control of pointer polymer impurities. In this paper, the development of this field in recent years is reviewed, the trends and progress in the quality control of cephalosporin antibiotic polymer impurities are discussed,and the problems that still need further consideration and research are proposed.

关 键 词：头孢菌素类抗生素 聚合物杂质 分析方法 结构研究 聚合规律 

分 类 号：R978.1[医药卫生—药品]