基于质量源于设计理念的中药制剂工艺研究进展

Research on Chinese Medicine Preparation Process Based on Quality by Design Concept: A Review

质量源于设计(QbD)作为先进的质量控制理念,逐渐被应用于制药领域,在中药制剂工艺中也有较大的研究空间。应用QbD理念要深入辨识中药制剂产品目标,强调对生产过程的理解和质量控制。对QbD理念在中药制剂工艺中的研究应用进展进行综述,包括提取、分离纯化、干燥、制剂成型等工艺单元,分析工艺环节的关键质量属性与关键工艺参数,指导建立设计空间。此外,由于中药制剂原料来源多样、工艺复杂、生产流程长、产品质量波动大,应注重实验设计及工艺建模,对工艺放大规律进行研究,结合过程分析技术,实现全过程质量控制,从而提高生产效率,保证中药制剂安全有效。

As an advanced quality control concept,quality by design(QbD)has been gradually applied to the pharmaceutical field,and there is still room for improving the Chinese medicine preparation process.The application of QbD concept requires an in-depth identification of the targets of Chinese medicine preparations,emphasizing the understanding of production process and quality control.This paper reviewed the research and applications of QbD concept in Chinese medicine preparation process,including extraction,separation and purification,drying,and preparation molding,and analyzed the key quality attributes and process parameters to guide the establishment of design space.In addition,considering the diverse sources of raw materials for Chinese medicine preparations,complex technics,long production process,and large fluctuations in product quality,attention should be paid to experiment design and process modeling.Research on patterns of process scale-up should be strengthened,and the process analysis technology should also be combined to achieve the whole process quality control,thus improving the production efficiency and ensuring the safety and effectiveness of Chinese medicine preparations.