多肽固相合成中起始物料的控制策略  

The control strategy of starting materials used in solid-phase peptide synthesis

作　　者：吴一凡 刘福利 WU Yi-fan;LIU Fu-li(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《中国新药杂志》2022年第10期937-941,共5页Chinese Journal of New Drugs

摘　　要：本文结合ICH理念、相关指导原则介绍了固相合成多肽过程中的起始物料树脂和保护氨基酸的控制策略,探讨了树脂的重要参数、保护氨基酸部分潜在杂质的形成机制及对终产物的影响,为提高多肽类药物的质量提供参考。Referring to the requirement of ICH concept and relevant guidelines, the strategy to control the qualities of resin and protected amino acid which are starting materials in solid-phase peptide synthesis were briefly introduced in this paper, mainly focusing on the important parameters of the resin, the formation mechanism of some potential impurities in the protected amino acids and their effects on the target peptide, in order to provide some references for enhancing the quality of peptide drugs.

关 键 词：固相多肽合成 起始物料 保护氨基酸 杂质 质量标准 

分 类 号：R95[医药卫生—药学]