多肽类药物质量控制研究进展  

Research progress of the quality control of peptide drugs

作　　者：田文静[1] 任雪[1] 廖海明[1] 杨化新[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《药物分析杂志》2013年第7期1115-1120,共6页Chinese Journal of Pharmaceutical Analysis

基　　金：化学新药质量标准研究与评价技术平台2011ZX09303-001

摘　　要：多肽类药物近年来呈蓬勃发展的态势,国内外药典收载的多肽类原料药标准有22个,制剂标准有26个。多肽类药物有关物质的控制多采用HPLC、CE和LC-MS检测方法。本文结合国内外的相关指导原则及现行版药典,并收集汇总相关文献资料,进行归纳总结,就多肽类药物的质量控制,特别是有关物质控制方面的内容,进行综述。阐述多肽类药物的质量控制现状,及国内外研究进展,为控制多肽类药物的质量提供参考。In recent years,polypeptides study has become a booming trend in new drug development.There are 22 monographs for APIs and 26 for preparations.The impurity in these drugs were usually measured by HPLC,CE and LC-MS.The present study collected and reviewed relevant literatures,the quality control especially impurity control was summarized.The current situation of quality control of peptide drugs and the research progress were described,which provices a reference for the quality control of peptide drugs.

关 键 词：多肽药物 质量控制 药典 杂质检测方法 

分 类 号：R917[医药卫生—药物分析学]