合成肽类药物的质量控制  

The Review of Quality Control of Chemically Synthetic Peptides Drug

作　　者：任丽萍[1] 范慧红[1] Ren Liping;Fan Huihong(National Institutes for Food and Drug Control,NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,国家药品监督管理局化学药品质量研究与评价重点实验室,北京102629

出　　处：《中国药事》2023年第8期925-931,共7页Chinese Pharmaceutical Affairs

基　　金：合成肽类创新药聚合物杂质关键分析技术研究(编号2023HYZX01)。

摘　　要：目的:为合成肽类药物的研究和质量控制提供参考。方法:从合成肽类药物的定义和分类入手,分析梳理合成肽类药物相关指导原则及不同药典中与其相关的通用技术要求现状。结果与结论:与传统药物相比,合成肽类药物结构复杂,质量属性分析方法的建立具有更大的难度和特殊性,质量控制的要点在于药物活性成分的结构表征、肽相关杂质的控制与分析和质量控制用标准物质的研制。Objective:To propose a reference for the research and quality control of chemically synthetic peptides drugs.Methods:Starting with the definition and classification of chemically synthetic peptides drugs,the current situation of guidance and general technical requirements of dif ferent pharmacopoeias was analyzed and sorted out.Results and Conclusion:Compared with traditional medicines,chemically synthetic peptides drugs have complex structures,and the establishment of analysis methods for quality attributes has greater difficulty and specificity.The key points of quality control lie in the structural characterization of the active pharmaceutical ingredients,the control and analysis of impurities of related peptides and development of standard substance for quality control.

关 键 词：多肽 化学合成肽 质量控制 肽相关杂质 

分 类 号：R917[医药卫生—药物分析学]