片剂连续制造中在线检测技术应用进展  

Progress in application of on-line inspection technology in continuous tablet manufacturing

作　　者：梁钧杰 张尧[2] 潘浩敏 饶小勇[1,2] 刘微[1,2] 罗晓健[1,2] 何雁[1] LIANG Jun-jie;ZHANG Yao;PAN Hao-min;RAO Xiao-yong;IU Wei;LUO Xiao-jian;HE Yan(Jiangxi University of Traditional Chinese Medicine,Nanchang 330004,China;National Engineering Research Center for Manufacturing Technology of Solid Preparation of Traditional Chinese Medicine,Nanchang 330006,China)

机构地区：[1]江西中医药大学,南昌330004 [2]中药固体制剂制造技术国家工程研究中心,南昌330006

出　　处：《中国新药杂志》2024年第8期774-784,共11页Chinese Journal of New Drugs

基　　金：江西省重大科技研发专项项目(20203ABC28W018);江西省03专项与5G项目(20212ABC03A36);南昌市高层次科技创新人才“双百计划”项目(洪科字[2022]321号)。

摘　　要：连续制造模式在食品、化学等行业应用多年,极大地促进了行业的发展。其有绿色节能、智能化等特点,可提升药品质量和生产效率,是未来药品生产的发展趋势。近些年已引起制药行业的广泛关注,但目前只有少量药品以连续制造模式生产获准上市。而连续过程中产品质量的检测十分重要,在线检测技术可快速分析待测性质,也可为设备间的工艺调控提供依据。本文总结近年来各制剂单元操作间使用近红外技术、拉曼光谱、微波传感等手段对原材料、中间产物及最终产品的关键质量属性进行检测的应用,描述了设备中检测位置对测量的影响,并简单介绍了不同连续制造产线构造及设备,以期对制药连续过程中进行在线检测技术应用及进一步研究提供参考。Continuous manufacturing mode has been applied in food,chemical and other industries for many years,which has greatly promoted the development of the industry.It is characterized by green energy saving and intelligence,which can improve the quality and production efficiency of drugs and is the future development trend of drug production.In recent years it has attracted widespread attention in the pharmaceutical industry,but currently only a small number of drugs produced in continuous manufacturing mode have been approved for marketing.The detection of product quality in the continuous process is very important,online testing technology can not only quickly analyze the nature of the test,but also provides a basis for the process control between equipments.This paper summarized the application of near-infrared(NIR)technology,Raman spectroscopy,microwave sensing and other means to detect key quality attributes of raw materials,intermediates and final products in the operation room of each preparation unit in recent years,described the influence of the detection position in the equipment on the measurement,and briefly introduced the structures of different continuous manufacturing production lines and equipments,with a view to providing reference for the application of on-line inspection technology in the continuous manufacturing process of pharmaceuticals and for further research.

关 键 词：连续制造 在线检测 关键质量属性 设备 

分 类 号：R943[医药卫生—药剂学]