腹膜透析液仿制药药学研究关注点探讨

Discussion on the focus of pharmaceutical research for generic peritoneal dialysis fluids

摘要

腹膜透析液是腹膜透析治疗不可或缺的重要组成部分。腹膜透析液为药械组合类产品,其给药连接系统较复杂,在设计、生产、质量控制、运输配送及治疗过程中均具有一定的复杂性,腹膜透析液的质量直接影响患者的生存质量。本文结合审评工作经验,对腹膜透析液的处方工艺、质量研究和质量控制、稳定性和包装系统等方面进行探讨,旨在为此类产品的研发提供有价值的参考和借鉴,不断提升产品质量。

Abstract

Peritoneal dialysis fluids are an indispensable and crucial component of peritoneal dialysis treatment.As a combination of drugs and medical devices,peritoneal dialysis fluids have a relatively complex drug delivery connection system.They present certain complexities in design,production,quality control,transportation and distribution,as well as treatment process.The quality of peritoneal dialysis fluids directly affects the quality of life of patients.This article,based on the experience of review work,discusses the prescription process,quality research and control,stability and packaging system of peritoneal dialysis fluids,in order to provide valuable references and lessons for the research and development of such products and continuously improve product quality.

关键词

腹膜透析液 / 腹膜透析 / 糖降解产物 / 处方工艺 / 质量控制

Key words

peritoneal dialysis fluid / peritoneal dialysis / glucose degradation product / formulation and manufacturing process / quality control

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