缩宫素生产工艺的工业化进展

Industrialization Process of Oxytocin Production

缩宫素作为临床广泛应用的多肽药物,其液相合成工艺的建立是多肽药物领域划时代的成就。近年来,固相合成方法发展迅速,已经成为多肽合成的主要工艺过程。本文比较了多肽药物的液相和固相合成方法,概述了国内缩宫素的生产工艺、质量控制、稳定性等研究情况,分析讨论了多种纯化方法的优缺点,并展望了缩宫素生产工艺的发展方向。

Oxytocin is one of the most common polypeptide drugs used in clinic application. Liquid phase synthesis process of oxytocin was developed in production. However, in recent years, solid phase synthesis has shown significant advantages in manufacturing of polypeptide drugs. In this paper, the liquid phase and solid phase synthesis processes of polypeptide drugs are compared, the domestic production technology, quality control and stability of oxytocin are summarized. We also analyze and discuss the advantages and disadvantages of various purification methods, and prospect the development direction of oxytocin production technology.