连续制造口服固体制剂药典标准通用技术要求探讨  

Discussion on General Technical Requirements of Pharmacopeia Standards for Continuous Manufacturing of Oral Solid Dosage

作　　者：曹萌 葛渊源 曹辉 李香玉 陈蕾[2] CAO Meng;GE Yuan-yuan;CAO Hui;LI Xiang-yu;CHEN Lei(Shanghai Center for Drug Evaluation and Inspection;Chinese Pharmacopoeia Commission)

机构地区：[1]上海药品审评核查中心 [2]国家药典委员会

出　　处：《中国食品药品监管》2023年第9期32-39,共8页China Food & Drug Administration Magazine

基　　金：2022年中国药品监督管理研究会(2022-Y-Y-005)。

摘　　要：连续制造在口服固体制剂领域的应用是制药先进技术发展的热点,随着国内外相关指导原则的落地实施,对其技术内容的规范化也提出了更高要求,因此我国相关国家标准也应持续地进行完善,特别是物料表征方法、质量研究方法、过程传感方法、工艺控制方法等通用技术要求方面。本文介绍了国内外药典标准对连续制造技术进步和规范发展的推动作用,分析了连续制造相关国家标准增修订的必要性,并结合国内外标准的发展现状提出了当前口服固体制剂领域的增修订建议。以期通过提升社会各界对药品连续制造通用技术要求的关注度,进一步加快相关领域标准化研究工作,助力我国制药行业先进制造技术高质量发展。The application of continuous manufacturing in oral solid dosage is a hot topic in the advancement of pharmaceutical technology.With the implementation of international and domestic guiding principles,higher requirements are put forward for the standardization of the content of continuous pharmaceutical manufacturing technology,which necessitates relevant national standards to be continuously improved,especially with regards to general technical requirements,such as material characterization methods,quality research methods,process sensing methods,process control methods,etc.This paper introduces the role of pharmacopoeia in promoting technological progress and addressing the need for standard development of pharmaceutical continuous manufacturing.Furthermore,it analyzes the necessity of updating and revising relevant pharmacopoeia standards for continuous manufacturing of oral solid dosage,and puts forward suggestions for potential changes based on the status quo observed both domestically and internationally.It is aimed to raise awareness about general technical requirements of continuous pharmaceutical manufacturing,foster standardization research in related fields,so as to facilitate the high-quality development of advanced manufacturing technology in China’s pharmaceutical industry.

关 键 词：药品 连续制造 国家标准 通用技术要求 增修订 

分 类 号：R95[医药卫生—药学]