中药制剂成分复杂，其质量控制一直是中药制剂研究、生产、监管关注的重点和难点。通过分析、总结中药制剂质量控制的特点，梳理近年来国家药品抽检对中药材及饮片、中成药所开展的探索性研究取得的工作成果，探讨探索性研究对中药制剂质量控制研究的意义以及中药制剂质量控制研究思路，认为目前中药制剂质量控制研究应是一个随着技术水平的发展、研究的不断深入而不断进行质量设计、质量完善的过程；探索性研究为中药制剂质量控制提供了有效的技术支撑，对探索性研究成果的利用有助于提高中药制剂质量控制水平；药品上市许可持有人应利用国家药品探索性研究成果，研究建立全过程质量控制体系，重视对药材源头的质量控制，重视全过程质量控制及相关研究，加强中药制剂整体质量表征和多途径控制研究，以提高中药制剂质量控制水平，提升中药制剂质量。

The quality control of traditional Chinese medicine (TCM) preparations has always been the focus and difficulty of research, production and supervision of TCM preparations due to its complex composition. In this paper, through analyzing and summarizing the characteristics of quality control of TCM preparations, sorting out the results obtained from exploratory research conducted by national drug sampling on TCM materials, decoction pieces and Chinese patent medicines in recent years, the significance of exploratory research on TCM preparations quality control research and research ideas of TCM preparations quality control were discussed. It is believed that the current quality control research of TCM preparations should be a process of continuous quality design and quality improvement with the development of the technology level and the continuous depth of research. The exploratory research provides effective technical support for TCM preparations quality control, and the utilization of exploratory research results helps to improve the quality control level of TCM preparations. Marketing authorization holder should make use of the national drug exploratory research results to study and establish the whole process quality control system, pay attention to the quality control of the source of herbs, pay attention to the whole process quality control and related research, and strengthen the overall quality characterization and multi-path control research of TCM preparations in order to improve the quality control level of TCM preparations and promote the quality of TCM preparations.

中国药品监管科学研究行动计划第二批重点项目