稳定多肽药物的制备工艺与质量控制研究

Preparation process and quality control of stable polypeptide drugs

摘要

本文剖析稳定多肽药物的制备工艺与质量控制核心技术，结合靶向新冠肺炎病毒刺突蛋白受体结合区域的稳定多肽项目，报告了对线性多肽进行关环构建的稳定多肽对新冠肺炎病毒刺突蛋白有更强的结合能力。鉴于多肽类生物稳定性和穿膜性差，易水解等问题对成药性的限制，系统性的研究旨在全面提升多肽药物稳定性与生物活性，保障其安全性和有效性。综合多肽特性与前沿生物技术，提出创新制备工艺与质量控制策略，为多肽药物研发生产筑牢理论与实践根基。

Abstract

This paper analyzes the preparation process and quality control core technology of stable polypeptide drugs, combined with the stable polypeptide project targeting the receptor binding region of the COVID-19 virus spike protein, and reports that the stable polypeptide of the linear polypeptide has a stronger binding ability to the COVID-19 virus spike protein. In view of the poor biological stability and membrane penetration of peptides, easy hydrolysis, the systematic research aims to comprehensively improve the stability and biological activity of peptides, and ensure their safety and effectiveness. Based on polypeptide characteristics and cutting-edge biotechnology, innovative preparation processes and quality control strategies are proposed, so as to lay a solid theoretical and practical foundation for the development and production of polypeptide drugs.

关键词

多肽药物 / 制备工艺 / 质量控制

Key words

polypeptide drug / preparation process / quality control

参考文献

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基金资助

国家自然科学基金(22107045)

国家自然科学基金(82472934)

国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院深圳医院课题(E010221005)

国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院深圳医院课题(CFA202201006)