以功效物质为质量目标的中药生产过程质量控制研究与实践  

Research and Practice on Quality Control of Chinese Medicine Production Process with Functional Substances as Quality Target

作　　者：肖伟[1,2] 张欣 徐芳芳[1,2] 章晨峰[1,2] 王振中[1,2] XIAO Wei;ZHANG Xin;XU Fangfang;ZHANG Chenfeng;WANG Zhenzhong(State Key Laboratory on Technologies for Chinese Medicine Pharmaceutical Process Control and Intelligent Manufacture(Jiangsu Kanion Pharmaceutical Co.,Ltd.&Nanjing University of Chinese Medicine),Nanjing 210023,China;Jiangsu Kanion Pharmaceutical Co.,Ltd.,Lianyungang 222001,China)

机构地区：[1]中药制药过程控制与智能制造技术全国重点实验室(江苏康缘药业股份有限公司/南京中医药大学),江苏南京210023 [2]江苏康缘药业股份有限公司,江苏连云港222001

出　　处：《南京中医药大学学报》2024年第10期1030-1038,共9页Journal of Nanjing University of Traditional Chinese Medicine

基　　金：中国工程院战略研究与咨询项目(2022XY-44)。

摘　　要：中药生产过程质量控制是影响中药产品质量的关键,但中药成分的多样性和生产过程的复杂性给过程质量的精准控制带来巨大挑战。首先提出了以功效物质为核心的中药智能化控制理念,系统阐释了中药质量的科学内涵,为中药复杂成分体系“控什么”“怎么控”提供了理论依据。同时,通过先进信息化、数字化和智能化技术,对中药生产过程开展了智改数转的研究和建设实践。最终建立了以功效物质为质量目标的中药生产过程质量控制体系,为解决过程质量控制难题提供了契机。The quality control during the manufacturing process of traditional Chinese medicine(TCM)is paramount to ensuring the quality of the final product.However,the sheer diversity of TCM ingredients and the intricacies of the production process pose significant challenges to achieving precise quality control.The review introduced an intelligent control concept centered on functional substances in TCM quality,which comprehensively explained the scientific essence of TCM quality,and provided a theoretical foundation for determining“what to control”and“how to control”within the complex system of TCM components.Furthermore,through the advanced informatization,digitization,and intelligent technologies,our team has conducted extensive research and construction practices on the intelligent transformation and digital upgrade of traditional Chinese medicine(TCM)manufacturing processes.Ultimately,the establishment of a quality control system tailored specifically for TCM manufacturing with functional substances serving as the primary quality target,which presented an opportunity to solve the difficult problem of process quality control in TCM manufacturing.

关 键 词：中药生产 过程质量控制 功效物质 智能制造 过程分析技术 

分 类 号：R283[医药卫生—中药学]