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刊物信息

期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nicpbp.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

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重组蛋白药物制品相关蛋白的分析与评价

Analysis and evaluation of product-related proteins in recombinant protein therapeutics

作者: 陶磊, 饶春明 
作者(英文):
分类号:R917
出版年·卷·期(页码):2018,38 (11):1854-1864
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

我国的重组蛋白药物产业经过20多年的发展,建立了一套比较完备的质量控制体系,但是与国外发达国家相比,还存在一定的差距。随着技术的更新和进步,我国重组蛋白药物的质量控制技术也有待加强。2017年,国家药典委员会立项标准提高课题,主要针对重组细胞因子的制品相关蛋白展开研究。作为课题的一部分,本文对制品相关蛋白的分析与评价进行了介绍,内容包括制品相关蛋白的概念、国内外对制品相关蛋白的技术法规要求、制品相关蛋白的产生及其对产品质量的影响、制品相关蛋白的分析方法等。

-----英文摘要:---------------------------------------------------------------------------------------

After more than 20 years of development,the recombinant protein pharmaceutical industry in China has established a relatively complete quality control system,but there is still a gap compared with foreign developed countries. With the update and progress of technology,the quality control technology of recombinant protein drugs in China needs to be strengthened. In 2017,Chinese Pharmacopoeia Commission set up a project to improve the standards,which focuses on product-related proteins (PRPs) in recombinant cytokines. As part of the project,this article introduces the analysis and evaluation of PRPs,including the concept of PRPs,technical and regulatory requirements for PRPs at home and abroad,the production of PRPs and their effects on product quality,and analysis methods of PRPs,etc.

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