中药复方制剂工艺研究问题、模式与策略

Problems, models, and strategies of preparation process of Chinese materia medica compound formulations

中药复方是中医临床用药的主要形式和手段,在保障中药复方制剂安全、有效、稳定、可控的基础上,合理设计中药复方制剂的工艺路线、生产装备和质量控制方法,建立一套符合中药复方制剂特点的工艺研究模式尤为重要。基于中药复方制剂的政策、工艺、装备现状,运用整体观、动态观和辨证观分析中药复方制剂的工艺模式,突破中药复方制剂的研究难点,提出中药复方制剂工艺开发的研究策略,以期为中药复方制剂工艺研究提供参考。

Chinese materia medica（CMM） compound is the main form and method of clinical drug in traditional Chinese medicine. On the basis of guaranteeing the safety, efficiency, stability, and controllability of CMM compound preparations, it is particularly important to rationally design process routes, production equipment, and quality control methods, and to establish a processing research model which conforms to the characteristics of CMM compound preparations. According to the status of policy, process, and equipment of CMM compound preparations, we analyze the technological mode of CMM compound preparations using holistic view, dynamic view, and dialectical view, break through the difficulties of this study, and propose research strategies for the development of CMM compound preparations, hoping to provide references for the preparation of CMM compound formulations.