青霉素类抗生素的聚合物分析  

Analysis of polymers of penicillin antibiotics

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2期105-113,共9页Chinese Journal of Antibiotics

摘　　要：在青霉素类药物杂质谱的控制中,对聚合物类杂质的分析是最薄弱环节,本文对近年来青霉素类抗生素在聚合物分析中取得的进展进行了综述。凝胶色谱-柱切换-质谱分析技术的广泛应用,使得人们对青霉素的聚合反应机理、结构等的认知不断完善,已逐渐形成了相对系统的聚合物分析策略与方法。通过理论计算结合强制聚合反应是进行聚合物分析的较理想方案;利用LC-MS在线分析技术,通过选择适宜的质谱条件获取聚合物聚合位点的结构信息,是推测聚合物结构的最有效途径;通过对各类聚合物质谱裂解规律的系统总结,有助于对聚合物结构的解析。Analysis of polymer impurities of penicillins is the weakest link in the impurity profiling. In this paper, the progress of analysis on penicillin polymers in recent years is reviewed. With the wide application of gel chromatography-column switching LC/MS, the structure of penicillin polymers and the polymerization mechanism have gradually been understood, which led to a systematic polymer analysis strategy and analysis methods.Theoretical calculation combining with the analysis of forced polymerization samples is an ideal scheme for the polymer analysis. To predict the structure of a polymer by using LC-MS online technology, the most effective way is by selecting suitable MS parameters to obtain its information at polymerization site. To summarize systematically the mass fragmentation process of different kinds of polymers is helpful to analyze the polymer structure.

关 键 词：青霉素 杂质谱 聚合物 LC-MS 裂解途径 

分 类 号：R978.1[医药卫生—药品]