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.
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)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2022年第10期937-941,共5页
Chinese Journal of New 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
solid-phase peptide synthesis
starting material
protected amino acid
impurity
quality standard
