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中药制剂的生产大多采用比较传统的生产方式,产品的质量更多地依赖于终端控制。对其在生产过程中可能发生的问题不可预测,多数情况下仅依靠经验判断。由此,也很难找到影响生产工艺过程和产品质量的关键可控点。该文通过介绍中药新药成型工艺的最新研究成果,提出了基于QbD理念的中药新药成型工艺的研发模式,即借鉴粉体学和流体学的基本理论,表征中药制剂原料的物理属性,从加强制剂原料物理属性、制剂工艺、制剂产品质量之间相关性研究着手,更科学、合理地设计中药制剂成型工艺,并从中发现影响中药制剂质量的各种可能因素以及它们的影响程度,预测中试放大和生产过程中可能出现的问题,为中药制剂的研发与生产提供参考,也可为今后逐步实现中药制剂“过程控制”提供支撑。
Traditional Chinese medicine production mostly adopts more traditional production methods, the quality of the products depends more on the terminal control. Unpredictable problems that may occur in the production process, in most cases only rely on experience to judge. As a result, it is difficult to find the key control points that affect the production process and product quality. By introducing the latest research results of new drug forming process of traditional Chinese medicine (TCM), this paper proposed a research and development mode of new drug forming technology based on QbD concept, that is, drawing on the basic theory of powder science and fluid science to characterize the physical properties of traditional Chinese medicine raw materials, The physical properties of raw materials, preparation technology, product quality research related to proceed with a more scientific and rational design of traditional Chinese medicine formulations forming process, and found that the quality of Chinese medicine formulations from the various possible factors and their impact on the forecast pilot enlarge And the possible problems in the production process, provide a reference for the research and development and production of traditional Chinese medicine preparations, and also provide support for the gradual realization of Chinese medicine preparation “process control ” in the future.