Wang Ya-Qi, Jiao Jiao-Jiao, Wu Zhen-Feng, Zheng Qin, Yang Ming
Chengdu University of Traditional Chinese Medicine, Chengdu 611130, China.
Jiangxi University of Traditional Chinese Medicine, Nanchang 330004, China.
Zhongguo Zhong Yao Za Zhi. 2018 Jan;43(1):197-203. doi: 10.19540/j.cnki.cjcmm.2018.0006.
"High quality, safety and effectiveness" are the primary principles for the pharmaceutical research and development process in China. The quality of products relies not only on the inspection method, but also on the design and development, process control and standardized management. The quality depends on the process control level. In this paper, the history and current development of quality control of traditional Chinese medicine (TCM) preparations are reviewed systematically. Based on the development model of international drug quality control and the misunderstanding of quality control of TCM preparations, the reasons for impacting the homogeneity of TCM preparations are analyzed and summarized. According to TCM characteristics, efforts were made to control the diversity of TCM, make "unstable" TCM into "stable" Chinese patent medicines, put forward the concepts of "holistic view" and "QbD (quality by design)", so as to create the "holistic, modular, data, standardized" model as the core of TCM preparation quality process control model. Scientific studies shall conform to the actual production of TCM preparations, and be conducive to supporting advanced equipment and technology upgrade, thoroughly applying the scientific research achievements in Chinese patent medicines, and promoting the cluster application and transformation application of TCM pharmaceutical technology, so as to improve the quality and effectiveness of the TCM industry and realize the green development.
“高质量、安全与有效”是中国药品研发过程的首要原则。产品质量不仅取决于检验方法，还取决于设计与研发、过程控制和标准化管理。质量取决于过程控制水平。本文系统回顾了中药制剂质量控制的历史与当前发展。基于国际药品质量控制的发展模式以及对中药制剂质量控制的误解，分析并总结了影响中药制剂均一性的原因。根据中药特性，努力控制中药的多样性，将“不稳定”的中药制成“稳定”的中成药，提出“整体观”和“质量源于设计（QbD）”的理念，从而创建以“整体、模块化、数据化、标准化”模式为核心的中药制剂质量过程控制模型。科学研究应符合中药制剂的实际生产情况，有利于支持先进设备和技术升级，将科研成果充分应用于中成药，推动中药制药技术的集群应用和转化应用，以提高中药产业的质量和疗效，实现绿色发展。
