LC-MS/MS技术在蛋白质药物生物定量分析中的应用进展  

Advances in LC-MS/MS for Biological Quantitative Analysis of Protein Drugs

作　　者：宇家仪 郝依萌 马璟 YU Jiayi;HAO Yimeng;MA Jing(China State Institute of Pharmaceutical Industry,Shanghai 201203;Shanghai InnoStar Biotech Co.,Ltd.,Shanghai 201203;Fudan University,Shanghai 201203)

机构地区：[1]中国医药工业研究总院,上海201203 [2]上海益诺思生物技术股份有限公司,上海201203 [3]复旦大学,上海201203

出　　处：《中国医药工业杂志》2022年第12期1689-1698,共10页Chinese Journal of Pharmaceuticals

摘　　要：蛋白质药物包括治疗用蛋白质(酶和调节蛋白)、靶向蛋白质(抗体药物)、蛋白质疫苗及诊断用蛋白质等,因特异性强、不良反应小且疗效显著而成为新药研发的热点领域之一。随着蛋白质药物的快速发展,对其生物分析方法也提出了更高的要求。为支持此类药物在药代动力学和毒代动力学方面的研究,需建立更加灵敏、准确和高通量的生物分析方法。近年来,液相色谱-串联质谱(LC-MS/MS)技术发展迅速,已成为蛋白质药物定量分析的新方法。该研究介绍了LC-MS/MS技术在蛋白质药物定量分析方法中的应用进展,并详细介绍了自下而上分析方法的具体试验流程,为LC-MS/MS技术测定蛋白质药物的研究提供了参考。Protein drugs include therapeutic proteins with enzymatic or regulatory activity,targeted protein such as antibody drugs,protein vaccines and protein diagnostics.Protein drugs have been one of the most focused areas in new drug development due to their strong specificity,slight adverse drug reaction and significant therapeutic effect.With the rapid development of protein drugs,higher requirements are put forward for their bioanalysis methods.To support the research of pharmacokinetics and toxicokinetics,more sensitive,accurate and high-throughput bioanalytical methods need to be established.In recent years,LC-MS/MS has emerged as a promising and versatile tool for quantitative analysis of protein drugs,owing to its rapid development.In this study,the application progress of LC-MS/MS to the quantitative analysis of protein drugs is summarized,and the specific experimental process of bottom-up analysis method in detail is introduced,which provides a reference for the study of LC-MS/MS in the determination of protein drugs.

关 键 词：蛋白质药物 定量分析 LC-MS/MS 

分 类 号：R917[医药卫生—药物分析学]