Cheng Yi-Yu, Qian Zhong-Zhi, Zhang Bo-Li
Department of Chinese Medicine Science & Engineering, Zhejiang University, Hangzhou 310058, China.
Chinese Pharmacopoeia Commission, Beijing 100061, China.
Zhongguo Zhong Yao Za Zhi. 2017 Jan;42(1):1-5. doi: 10.19540/j.cnki.cjcmm.2017.0002.
The current situation, bottleneck problems and severe challenges in quality control technology of Chinese Medicine (CM) are briefly described. It is presented to change the phenomenon related to the post-test as the main means and contempt for process control in drug regulation, reverse the situation of neglecting the development of process control and management technology for pharmaceutical manufacture and reconstruct the technological system for quality control of CM products. The regulation and technology system based on process control and management for controlling CM quality should be established to solve weighty realistic problems of CM industry from the root causes, including backwardness of quality control technology, weakness of quality risk control measures, poor reputation of product quality and so on. By this way, the obstacles from poor controllability of CM product quality could be broken. Concentrating on those difficult problems and weak links in the technical field of CM quality control, it is proposed to build CMC (Chemistry, Manufacturing and Controls) regulation for CM products with Chinese characteristics and promote the regulation international recognition as soon as possible. The CMC technical framework, which is clinical efficacy-oriented, manufacturing manner-centered and process control-focused, was designed. To address the clinical characteristics of traditional Chinese medicine (TCM) and the production feature of CM manufacture, it is suggested to establish quality control engineering for CM manufacturing by integrating pharmaceutical analysis, TCM chemistry, TCM pharmacology, pharmaceutical engineering, control engineering, management engineering and other disciplines. Further, a theoretical model of quality control engineering for CM manufacturing and the methodology of digital pharmaceutical engineering are proposed. A technology pathway for promoting CM standard and realizing the strategic goal of CM internationalization is elaborated.
简要描述了中药质量控制技术的现状、瓶颈问题和严峻挑战。提出改变药品监管中以事后检验为主、轻视过程控制的现象，扭转忽视制药生产过程控制与管理技术发展的局面，重构中药产品质量控制技术体系。应建立基于过程控制与管理的中药质量控制法规和技术体系，从根本上解决中药产业面临的质量控制技术落后、质量风险控制措施薄弱、产品质量声誉不佳等重大现实问题，突破中药产品质量可控性差的障碍。针对中药质量控制技术领域的难题和薄弱环节，提出构建具有中国特色的中药产品化学、生产和控制（CMC）法规，并尽快推动该法规获得国际认可。设计了以临床疗效为导向、以生产方式为中心、以过程控制为重点的CMC技术框架。针对中药的临床特点和中药生产的特性，建议通过整合药物分析、中药化学、中药药理学、制药工程、控制工程、管理工程等多学科，建立中药制造质量控制工程。此外，还提出了中药制造质量控制工程的理论模型和数字化制药工程方法。阐述了提升中药标准、实现中药国际化战略目标的技术路径。
