化药口服固体制剂连续制造质量控制及其发展策略研究  

Research on the quality control and development strategy of continuous manufacturing of chemical oral solid preparations

作　　者：李香玉 林晓凤 兰毅鹏 黄哲[1] LI Xiang-yu;LIN Xiao-feng;LAN Yi-peng;HUANG Zhe(School of Business Administration,Shenyang Pharmaceutical University,Shenyang 110016,China;Shanghai Center for Drug Evaluation and Inspection,Shanghai 200120,China)

机构地区：[1]沈阳药科大学工商管理学院,沈阳110016 [2]上海药品审评核查中心,上海200120

出　　处：《中国新药杂志》2024年第19期1976-1981,共6页Chinese Journal of New Drugs

摘　　要：连续制造技术是一种已被证明有极大优势的新兴技术。相比于传统的批量制造,连续制造拥有更集成、单元操作更少、设备占用空间小、工艺放大变异性小、过程质控更及时等特点,但在制药领域仍处于应用初期。化药口服固体制剂作为连续制造在制药领域的先行实验,仍面临一些挑战。因此,本研究通过综合文献研究和实验数据分析,提出了一些基于质量控制的连续制造策略,以确保化药口服固体制剂的质量稳定性。Continuous manufacturing technology is an emerging technology that has been proven to have great advantages.Compared to traditional batch manufacturing,continuous manufacturing is characteristic of high integration,few unit operations,and small equipment footprint,but it is still in the early stages of application in the pharmaceutical field.As a pioneer experiment in the pharmaceutical field for continuous manufacturing,oral solid formulations of chemical drugs still face some challenges.Therefore,this study proposes some continuous manufacturing strategies based on quality control through comprehensive literature research and experimental data analysis to ensure the quality stability of chemical oral solid formulations.

关 键 词：连续制造 质量控制 化药口服固体制剂 发展策略 监管科学 

分 类 号：R95[医药卫生—药学]