连续制造研究进展及中药过程知识系统研究  

Research progress of continuous manufacturing and process knowledge system of traditional Chinese medicine

作　　者：倪鸿飞 何衍钦 沈欢超 陈勇[1] 刘雪松[1] NI Hong-fei;HE Yan-qin;SHEN Huan-chao;CHEN Yong;LIU Xue-song(College of Pharmaceutical Sciences,Zhejiang University,Hangzhou 310058,China)

机构地区：[1]浙江大学药学院,浙江杭州310058

出　　处：《中国中药杂志》2021年第8期2045-2050,共6页China Journal of Chinese Materia Medica

基　　金：国家“重大新药创制”科技重大专项(2018ZX09201-010)。

摘　　要：近几年,美国FDA陆续提出连续制造(continuous manufacturing, CM)的概念,并鼓励企业推进实施,这也成为了未来制药技术的热门研究方向。2019年2月,FDA发布了实施连续制造的指南草案,这对CM的发展起到了极大的推动作用,同时也为中药生产的连续化提供借鉴。中药生产是较为复杂的过程体系,随着生产设备革新,中药生产自动化、信息化推进上线,现有的政策法规和传统的生产控制能力难以满足市场对高质量中药产品的需求。该文基于"QbD"理论和"PAT"技术,借鉴现代制造技术、信息技术和质量控制技术,综述了符合中药生产特点的质量控制新技术和新方法,并提出一种先进控制策略——过程知识系统(process knowledge system, PKS),旨在为中药生产实施CM提供参考。In the past few years, continuous manufacturing(CM) has been put forward by the FDA. Pharmaceutical enterprises are encouraged to promote the implementation of CM, which has become a hot research direction of pharmaceutical technology. In February 2019, the FDA issued a draft guideline for the implementation of CM, which greatly promoted the development of CM and provided reference for continuous manufacturing of traditional Chinese medicine(TCM). The production process of TCM is a complex system. With the innovation of production equipment and the promotion of automation and informatization of TCM production, the exis-ting policies, regulations and traditional production control capacity are difficult to meet the market demand for high-quality TCM pro-ducts. In this paper, we reviewed the new technologies and methods of quality control in accordance with the characteristics of TCM production by referring to modern manufacturing technology, information technology and quality control technology. Based on the "QbD" theory and "PAT" technology, process knowledge system(PKS), an advanced control strategy, was proposed to provide a reference for the implementation of CM in TCM production.

关 键 词：中药生产过程 连续制造 过程分析技术 停留时间分布 过程知识系统 

分 类 号：F426.72[经济管理—产业经济] F273.1