基于中药复方制剂特点的中药复方制剂生产工艺研究

中药复方制剂的生产工艺决定着中药复方制剂安全、有效的物质基础,是影响中药复方制剂质量的关键因素。研究中药复方制剂生产工艺的特点,探讨符合中药复方制剂特点的工艺研究模式,对科学合理设计中药复方制剂的工艺路线和优化工艺条件具有指导意义。通过对中药复方制剂生产工艺研究存在的问题进行分析和思考,结合《中药复方制剂生产工艺研究技术指导原则(试行)》中的基本原则和要求,提出基于中药复方制剂特点开展中药复方制剂生产工艺研究的思路,以期为中药复方制剂的工艺研究提供参考与借鉴。

Research of preparation process of Chinese materia medica compound preparation based on characteristics of Chinese materia medica compound preparation

The preparation process of Chinese materia medica (CMM) compound preparation determines the material basis of safety and effectiveness of CMM compound preparation, which is the key factor that affects the quality of CMM compound preparation. Research on characteristics of the production technology of CMM compound preparation and discuss on technological research mode which conforms to the characteristics of CMM compound preparation are instructive to scientifically and rationally design the technological route and optimize technological conditions of CMM compound preparation. The problems existing in the research of preparation process of CMM compound preparation are analyzed and considered in this paper, combined with the basic principles and requirements in Guideline for Processing Study of CMM Compound Preparation (Trial), the viewpoint that research of preparation process of CMM compound preparation should be based on characteristics of CMM compound preparation was put forward in order to provide reference for the research of preparation process of CMM compound preparation.