胸腺法新原料药及注射剂中聚合物的SEC-HPLC及MALDI-TOF/TOF-MS分析  

SEC-HPLC and MALDI-TOF/TOF-MS Analyses of the Polymer in Thymalfasin and Thymalfasin for Injection

作　　者：张颖 尹红锐 郑璐侠[1] 邵泓[1] 陈钢[1] ZHANG Ying;YIN Hongrui;ZHENG Luxia;SHAO Hong;CHEN Gang(NMPA Key Lab.for Quality Control of Therapeutic Monoclonal Antibodies,Shanghai Institute for Food and Drug Control,Shanghai 201203)

机构地区：[1]上海市食品药品检验所国家药品监督管理局治疗类单抗质量控制重点实验室,上海201203

出　　处：《中国医药工业杂志》2021年第5期682-685,共4页Chinese Journal of Pharmaceuticals

摘　　要：采用分子排阻色谱(SEC-HPLC)法测定了来自不同企业的10批胸腺法新原料药和28批注射用胸腺法新中的聚合物含量,并采用基质辅助激光解吸电离飞行时间质谱(MALDI-TOF/TOF-MS)法测定了各企业样品中聚合物的相对分子质量。结果显示,38批样品中聚合物含量为0.1%~1.6%,聚合物的相对分子质量为6199,推测聚合物为胸腺法新的二聚体。本试验样品为2018年国家药品抽验评价样品,代表性强,试验方法和试验结果为完善该品种的质量标准提供了参考。Molecular exclusion chromatography method was used to measure the content of polymer in 10 batches of thymalfasin and 28 batches of thymalfasin for injection collected from different enterprises.The molecular weight of polymer fraction was measured by matrix-assisted laser desorption ionization-time of flight mass spectrometry(MALDI-TOF/TOF-MS).The results showed that the polymer contents were between 0.1%and 1.6%in all 38 batches of samples.The relative molecular weight of the polymer was 6199,which suggested that the polymer would be a dimer of thymalfasin.The samples were collected representatively,based on national drug sampling evaluation in 2018.The method and results are helpful for the optimization of quality standard.

关 键 词：胸腺法新 注射剂 聚合物 分子排阻色谱法 基质辅助激光解吸电离飞行时间质谱 质量标准 

分 类 号：O657.7[理学—分析化学] R917[理学—化学]