多肽类药物质量控制研究进展
Research progress of the quality control of peptide drugs
分类号：
出版年·卷·期（页码）：2013,33 (7):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----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。
-----英文摘要：---------------------------------------------------------------------------------------
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.
-----参考文献：---------------------------------------------------------------------------------------
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