2015年版《中国药典》生物技术药质量控制相关内容介绍

发布时间：2018-03-16 01:33

本文选题：中国药典　切入点：生物技术药　出处：《中国药学杂志》2015年20期 　论文类型：期刊论文

【摘要】：2015年版《中国药典》已出版,为更好地了解和执行2015年版《中国药典》,笔者首先简要回顾了2010年版《中国药典》在出版后的生物技术药质量控制执行情况,列举了相关问题,说明及时学习和了解2015年版《中国药典》及相关文件的必要性。然后依据各相关法规和2015年版《中国药典》三部对与生物技术药质量控制密切相关的内容进行介绍,内容包括:质量标准研究依据及法规要求;凡例以及凡例第二十六条对标准品、参考品、对照品等标准物质的相关规定;生物制品通则以及与生物技术药生产与质量控制密切相关的6个规程;人用重组DNA技术产品总论和人用重组单克隆抗体产品总论;各论以及以我国2013年度评价性抽验注射用重组人干扰素α2a为例分析检定规程相关内容;检测方法通则以及新增附录干扰素生物学活性测定法第二法(报告基因法)。讨论分析了2015年版《中国药典》收载的产品各论制造与检定规程的优缺点以及当时制定质量标准时的法规与技术背景;重点讨论了肽图分析在重组产品蛋白质结构分析以及生产工艺稳定性评价方面的重要性,新增人用重组DNA技术产品总论部分关键性技术要求,液相质谱等新技术在生物技术药蛋白质结构分析以及对照品鉴定等方面的应用。
[Abstract]:The 2015 edition of Chinese Pharmacopoeia has been published. In order to better understand and implement the 2015 edition of Chinese Pharmacopoeia, the author first briefly reviewed the implementation of biotechnological drug quality control after the publication of 2010 edition of Chinese Pharmacopoeia, and listed some related problems. The necessity of studying and understanding the 2015 edition of the Chinese Pharmacopoeia and related documents in time is explained. Then according to the relevant laws and regulations and the 2015 edition of the Chinese Pharmacopoeia, the contents closely related to the quality control of biotech drugs are introduced. The contents include: the research basis of quality standards and the requirements of regulations and regulations, and the relevant provisions of standard materials, reference materials, reference materials, and other standard substances in all cases and 26th articles of examples; The general principles of biological products and six regulations closely related to the production of biotechnology drugs and quality control, the general introduction of human recombinant DNA technology and human recombinant monoclonal antibody. The relevant contents of verification regulation were analyzed with the example of recombinant human interferon 伪 2a for injection in China in 2013. General rules for detection and new appendix for the determination of biological activity of interferon the second method (report gene method). The advantages and disadvantages of the products contained in the 2015 edition of the Chinese Pharmacopoeia are discussed and analyzed, as well as the current system of the products published in the Chinese Pharmacopoeia. The regulation and technical background of the quality standard; The importance of peptide map analysis in protein structure analysis and process stability evaluation of recombinant products is discussed, and some key technical requirements of human recombinant DNA technology are introduced. Application of novel techniques such as liquid Mass Spectrometry in Biotechnology protein structure Analysis and reference substance Identification.
【作者单位】：中国食品药品检定研究院卫生部生物技术产品检定法及其标准化重点实验室;
【基金】：国家“重大新药创制”科技重大专项资助项目(2012ZX09304010)
【分类号】：R921.2

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