基于“整体观”的中药制剂质量过程控制体系探讨

Quality process control system of Chinese medicine preparation based on "holistic view"

＂质量可控、安全有效＂是我国药品研发过程须遵循的首要原则。产品质量的优劣不仅依靠检验方法,更依靠设计开发、过程控制及规范化管理等产品制造的所有环节,质量源于过程控制水平。该文首先系统回顾了中药制剂质量控制的历史和发展现状,借鉴国际药品质量控制的发展模式,并针对中药制剂质量控制的误区,分析总结影响中药制剂质量均一性的原因。针对中药特色的基础上,如何控制中药的多样性,将＂不均一＂的中药制成均一性良好的中成药,提出基于＂整体观＂和＂质量源于设计（quality by design,QbD）理念＂,创建＂整体化、模块化、数据化、规范化＂为核心的中药制剂质量过程控制＂四化＂模式。倡议科学研究需致力于中药制剂生产实际,结合先进装备技术升级,将科学研究成果切实做到中成药大品种中,推动中药制药技术集群创新和转化应用,实现中药产业提质增效、绿色发展。

＂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.