药品连续制造中常用的过程分析工具及其应用进展  

Process Analysis Tools Commonly Used in Continuous Pharmaceutical Manufacturing and Their Application Progress

作　　者：昝孟晴 牛剑钊[1] 许鸣镝[1] 刘倩[1] ZAN Mengqing;NIU Jianzhao;XU Mingdi;LIU Qian(NMPA Key Lab.for Research and Evaluation of Chemical Drug Quality,National Institutes for Food and Drug Control,Beijing 100050)

机构地区：[1]中国食品药品检定研究院,国家药品监督管理局化学药品质量研究与评价重点实验室,北京100050

出　　处：《中国医药工业杂志》2022年第10期1402-1407,共6页Chinese Journal of Pharmaceuticals

基　　金：国家重点研发计划重大疾病治疗药物制剂质量研究评价技术联合研究(2020YFE0201700)。

摘　　要：首先阐述了连续制造与过程分析技术的概念,并介绍了与药品连续制造相关的指导原则和相关控制策略的考虑。随后概述了药品连续制造过程中常用的分析工具(如近红外光谱法、拉曼光谱法、太赫兹脉冲成像、超声波技术、X射线显微成像技术等)的原理、特点及应用实例。最后总结了影响药品连续制造的因素和过程分析技术应用存在的困难,并对药品连续制造的发展方向进行展望,为与连续制造相关的过程分析技术的发展提供了参考。The concept of continuous manufacturing and process analysis technology is expounded, and the relevant guiding principles of continuous pharmaceutical manufacturing and the consideration of relevant control strategies are introduced. Then, the principles, characteristics and application examples of commonly used analytical tools, such as near-infrared spectroscopy, Raman spectroscopy, terahertz pulsed imaging, ultrasound technique and X-ray microscopy imaging technology, in the continuous pharmaceutical manufacturing process are summarized. Finally, the factors affecting the continuous manufacturing of pharmaceuticals and the difficulties in the application of process analysis technology are reviewed, and the development direction of continuous pharmaceutical manufacturing is prospected. It is hoped to provide a reference for the development of process analysis technology related to continuous manufacturing.

关 键 词：连续制造 过程分析技术 近红外光谱法 拉曼光谱法 太赫兹脉冲成像 超声波技术 X射线显微成像技术 

分 类 号：R917[医药卫生—药物分析学]