液相色谱-质谱联用技术在疫苗分析中的应用  

Application of Liquid Chromatography-Mass Spectrometry in Vaccine Analysis

作　　者：李阳 宋洋 王文涛 生宁 罗继 郭立海 张金兰[1] 陈泓序 LI Yang;SONG Yang;WANG Wen-tao;SHENG Ning;LUO Ji;GUO Li-hai;ZHANG Jin-lan;CHEN Hong-xu(Institute of Materia Medica,Chinese Academy of Medical Sciences;SCIEX,CHINA)

机构地区：[1]中国医学科学院药物研究所 [2]SCIEX,中国

出　　处：《中国食品药品监管》2023年第7期30-43,共14页China Food & Drug Administration Magazine

摘　　要：近年来,疫苗领域迎来了快速发展期,同时也面临着最严格的监管。与一般药品不同,疫苗主要用于预防,面向健康人群,婴幼儿是重要的接种人群,其质量直接关系着公众的生命安全。疫苗的研发及质量评价工作极具挑战性,为此,对其相应的分析技术也提出了更高的要求。质谱技术是目前最为重要的分析技术之一,其既可提供分子质量和结构等方面的信息,也可采用内标法或外标法对目标化合物进行定量分析,广泛应用于生物制品的早期发现、研发及生产等环节。本文结合多篇已发表的文献或技术文章,详细概述了液相色谱-质谱联用技术在疫苗分析中的应用,包括重组蛋白疫苗、病毒疫苗、多糖蛋白结合疫苗、核酸疫苗及辅料和佐剂的质量控制,以期为新型疫苗的研发和质量控制提供有效的分析方法。In recent years,the vaccine industry has experienced the most rapid development in the history,and is faced with the most stringent regulatory oversight.Unlike ordinary drugs,vaccines are mainly used for prevention and are targeted at healthy individuals,most of whom are infants.Therefore,the quality of vaccines has a direct bearing on public safety and wellbeing.The development and quality evaluation of vaccines pose significant challenges,requiring corresponding analytical techniques.Mass spectrometry is one of the most important analytical techniques at present,which can not only provide information on molecular mass and structure,but also enables quantitative analysis of target compounds using internal or external standard methods.It has been widely used in early discovery,development,and production of biological drugs.To provide effective analytical methods for the development and quality control of new vaccines,this paper comprehensively reviews a few published literature or technical papers to summarize the application of liquid chromatography-mass spectrometry in vaccine development,mainly involving the quality control of recombinant protein vaccines,viral vaccines,protein-polysaccharide conjugate vaccines,nucleic acid vaccines,excipients,and adjuvants.

关 键 词：液相色谱-质谱联用技术 重组蛋白疫苗 病毒疫苗 多糖蛋白结合疫苗 核酸疫苗 

分 类 号：R392-33[医药卫生—免疫学]