连续制造在口服固体制剂中的研究与应用  

Research and Application of Continuous Manufacturing for Oral Solid Dosage Forms

作　　者：唐艺菲 吴闻哲[1] 王健[1] TANG Yifei;WU Wenzhe;WANG Jian(National Pharmaceutical Engineering Research Center,China State Institute of Pharmaceutical Industry,Shanghai 201203)

机构地区：[1]中国医药工业研究总院药物制剂国家工程研究中心,上海201203

出　　处：《中国医药工业杂志》2022年第9期1227-1239,共13页Chinese Journal of Pharmaceuticals

摘　　要：口服固体制剂的生产模式正逐渐由批制造转向连续制造。利用过程分析技术对生产过程中的原材料、中间产品和最终产品的关键质量属性进行在线分析和控制,可实现高效率生产、自动化监控、高产品质量要求,并实现实时放行测试。连续制造集成了连续生产线、过程分析技术和先进反馈控制系统,更加符合制药工业4.0理念。本研究综述了连续制药的发展历程和现状、连续制造生产过程和过程分析技术在口服固体制剂连续制造中的应用,以期为口服固体制剂连续制造研究提供参考。The production mode of oral solid dosage forms is gradually changing from batch to continuous manufacturing.Using process analysis technology to analyze and control the critical quality attributes of raw materials,intermediate products and final products can realize high efficiency manufacturing,automatic monitoring,high product quality requirements and real-time release testing.Continuous manufacturing which integrates continuous production lines,process analysis technology and advanced feedback control system is more in line with the concept of pharmaceutical industry 4.0.In this paper,the development and status,the preparation process and application of process analysis technology in oral solid dosage forms are reviewed to provide references for further research.

关 键 词：连续制造 过程分析技术 先进反馈控制系统 口服固体制剂 

分 类 号：R944.9[医药卫生—药剂学]