蛋白琥珀酸铁口服溶液仿制药药学研究相关问题的考虑

Considerations on the issues related to pharmaceutical research of generic iron proteinsuccinylate oral solution

本文介绍了大分子口服补铁剂蛋白琥珀酸铁口服溶液的基本情况,对第三代补铁制剂蛋白琥珀酸铁口服溶液的仿制药开发的药学关注点进行了综述,基于仿制药的相关技术要求,结合蛋白琥珀酸铁的结构特点和作用机制,从原料药研发、结构确证、处方工艺开发、质量研究、稳定性等方面,对蛋白琥珀酸铁口服溶液仿制药药学研究中应重点关注的问题进行了探讨,对于蛋白琥珀酸铁口服溶液的仿制药研发提供了药学研究的思路和关注点,以供仿制药研发和注册申报时参考。

This paper introduces marketing and clinical application of iron proteinsuccinate oral solution,reviews the pharmaceutical concerns of generic drug development of the third generation iron supplement protein iron succinate oral solution,discusses the key issues of generic drugs for iron proteinsuccinylate oral solution during the pharmaceutical research.From the aspects of active pharmaceutical ingredients(API)research and development,structural confirmation,prescription and process,quality research and stability,recent domestic technical requirements for generic drugs,the structural characteristics and the mechanism of protein iron succinate are considered as starting points to talk about pharmaceutical research ideas and concerns for the development of generic drugs for iron proteinsuccinylate oral solution.This article provides a reference for the research and development and registration of generic drugs.