摘要
生物技术药物近年来飞速发展,其质量控制也越来越受到关注。脱酰胺化反应是生物技术药物质量控制中不可忽视的一方面,特别是脱酰胺化产生的异天冬氨酸(iso Asp)。该文描述天冬酰胺(Asn)残基的脱酰胺化,以及脱酰胺化对生物技术药物的影响。对国内外脱酰胺化的检测方法进行汇总,包括处理方法和仪器分析方法。其中对iso Asp位点的鉴定和含量测定进行较为详细地介绍。开展脱酰胺化的研究对我国生物技术药物的质量控制具有积极的意义。
Quality control of biotech drugs has attracted increasing attentions in recent years.Deamidation reaction is one of the major concerns in quality control of biotech drugs,due to the generation of isoaspartic acid(isoAsp).This paper describes the deamidation of asparagine(Asn)residues and its effects on the biological drugs.The detection methods currently used in China and overeas for this reaction,including pretreatment protocols and instrumental analysis were described.The identification and determination of isoaspartyl sites were also described in detail,along with the positive impact on the development of biotech drugs in China by the studies on deamidation reactions.
作者
李恒
何雁南
马吉胜
刘姗姗
周朝晖
LI Heng;HE Yannan;MA Jisheng;LIU Shanshan;ZHOU Zhaohui(Wuhan Institute for Drug and Medical Device Control,Wuhan 430075,China;School of Pharmaceutical Sciences,Wenzhou Medical University,Wenzhou 325035,China;Department of Chemistry and Chemical Biology,Barnett Institute of Chemical and Biological Analysis,Northeastern University,Boston,MA 02115,USA)
出处
《医药导报》
CAS
北大核心
2019年第2期147-152,共6页
Herald of Medicine
基金
武汉市第五批"黄鹤英才计划"(2017)
湖北省食品药品监督管理局科研项目(201801013)
