论中药制造测量学之4个关键工程技术难题  

Four critical engineering and technical problems in manufacturing measurement of traditional Chinese medicine

作　　者：吴志生[1,2] 乔延江[1,2] 肖伟[2,3] 王琦 WU Zhi-sheng;QIAO Yan-jiang;XIAO Wei;WANG Qi(School of Chinese Materia Medica,Beijing University of Chinese Medicine,Beijing 102488,China;Engineering Research Center of Chinese Materia Medica Production and New Drug Development,Ministry of Education,Beijing 102488,China;National Key Laboratory on Technologies for Chinese Medicine Pharmaceutical Process Control and Intelligent Manufacture,Lianyungang 222001,China;National Institute of TCM Constitution and Preventive Medicine,Beijing University of Chinese Medicine,Beijing 100029,China)

机构地区：[1]北京中医药大学中药学院,北京102488 [2]中药制药与新药开发教育部工程研究中心,北京102488 [3]中药制药过程控制与智能制造技术全国重点实验室,江苏连云港222001 [4]北京中医药大学国家体质与治未病研究院,北京100029

出　　处：《中国中药杂志》2023年第11期2841-2855,共15页China Journal of Chinese Materia Medica

基　　金：国家重点研发计划项目(2022YFC3501902);国家医学攻关产教融合创新平台项目(90010062820031);国家自然科学基金优秀青年科学基金项目(82022073);国家自然科学基金面上项目(82274110);国家重点实验室基金项目(SKL2020Z0304)。

摘　　要：围绕中药产业发展与质量提升战略,破解“卡脖子”困局,要重视中医药新工科科技创新。在科技创新体系生态化和产业革命背景下,超大规模的信息交互与多维融合必将引发中药制造模式的深刻变革。中药制造测量学是在中药生产过程控制可靠性工程理论基础上形成的;是系统论与系统科学思维的发展延伸;是中药学科坚持“四个面向”再认识论的提高,是一门理论结合实践的交叉融合学科。针对中药制造原料来源复杂、过程工艺粗放、物质基础不清晰、装备工艺适用性较差等难题,开拓形成了“瞄准药工融合-研发智能产线-赋能产业转型”的转化研究模式。该文提出了开展中药制造关键质量属性辨识、中药制造工艺质量源于设计与产品研制、中药制造质量传递与过程能力指数研究、中药制造测量技术与装备开发4个关键工程技术难题,以实现中药质控指标系统化、工艺管控实时化、制造过程数字化、质量传递透明化以及全程控制智能化。该文提出的新概念、新理论与新技术将为中药产业化提供参考。Focusing on the development and quality improvement strategy of the traditional Chinese medicine(TCM)industry,the scientific and technological innovation of the new engineering of TCM should be paid attention to solve the"stuck neck"dilemma.Under the background of the ecological and industrial revolution of the scientific and technological innovation system,the super-scale information interaction and multi-dimensional integration will inevitably lead to profound changes in the manufacturing mode of TCM.Manufacturing measurement of TCM is formed on the basis of the reliability engineering theory of process control of TCM production.It is the development extension of system theory and system science ideas and a cross-fertilization discipline that combines theory with practice and adheres to the"four-oriented"re-epistemology improvement of the TCM discipline.In response to the problems of complex raw material sources,coarse process technology,unclear material basis,and poor applicability of equipment and technology in the manufacture of TCM,the transformation research mode of"aiming at the integration of pharmaceutical industry-developing intelligent production line-enabling industrial transformation"has been developed.This paper proposed the four key engineering technical problems,i.e.,the identification of critical quality attributes(CQA)in the manufacture of TCM,the quality by design(QbD)and product development of the manufacturing process of TCM,the quality transfer principle and multivariate process capability index of TCM manufacturing,and the development of measurement technology and equipment of the manufacturing measurement of TCM,to achieve the systematization of quality control indicators,real-time process control,digitalization of manufacturing process,transparency of quality transfer,and intelligent whole-process control.In this paper,the new concepts,new theories,and new technologies provide a reference for the industrialization of TCM.

关 键 词：关键质量属性 质量传递 质量源于设计 全程质量控制 中药制造测量学 

分 类 号：R288[医药卫生—中药学]