摘要
生物制品药物已经成为近年来快速发展的一类新兴药物领域,包括人用预防药物和治疗药物。蛋白质和多肽是生物制品药物的重要活性物质之一。与化学药物不同,蛋白质药物具有分子量大、结构复杂多变的特殊性,因此其理化性质更加多样,杂质成份不确定性高,发生免疫反应的可能性大。为确保药物的安全性和有效性,针对蛋白质药物自身的特点,依据国内外相关标准,建立一系列配套齐全的蛋白质药物分析方法和质量控制技术具有非常重要的意义。本文对生物质谱技术(Bio-MS)在蛋白质药物结构鉴定和翻译后修饰分析中的应用进行了系统介绍,力图通过重组尿激酶原(rhProUK)、重组人促红细胞生成素(rhEPO)和凝血因子X激活剂(RVV-X)等药物分析实例,提供一些可以借鉴的蛋白质药物分析的生物质谱技术方法。
In recent years,Biologicals has become a new field of drug RD rapidly,including empodistic and therapeutic drugs for human use.The main active substance of Biologicals are proteins and polypeptides.Because protein drugs are with some specificities different from chemical drugs,such as high molecular weight,complicated structure,uncertaint inpurity and possible immunogenicity,the safety and efficacy of drugs is extremely important.Thus based on the international and domestic standards,it is great significant to establish a complete series of pharacetutical analysis methods and quality control technologies for the characteristics of protein drugs.This review focuses on the introduction of the applications of Bio-MS in the conformation of protein structure and analysis of post-translational modification,for example,rhProUK,rhEPO,RVV-X and so on,which can provide some references.
出处
《现代科学仪器》
2011年第5期23-28,共6页
Modern Scientific Instruments
关键词
质谱
药物分析
蛋白质鉴定
翻译后修饰
结构确证
Mass Spectrometer
Pharmaceutical Analysis
Protein Identification
Post-translational Modification
Structure Conformation
