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.
作者
李香玉
林晓凤
兰毅鹏
黄哲
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)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2024年第19期1976-1981,共6页
Chinese Journal of New Drugs
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
continuous manufacturing
quality control
chemical oral solid preparations
development strategy
drug regulatory science
