论中药制剂工艺参数与质量参数的关联性与协调性

Association and coordination between process parameter and quality parameter of Chinese material medica preparations

工艺参数与质量参数是在中药制剂形成过程中建立的2个互为关联、相互制约的要素,二者的对立统一性反映了过程控制的作用,体现出原料药物如何蜕变为药品的特殊历程。本文通过分析影响中药制剂制备中的工艺参数与质量参数,提出建立二者联系的必要性,实现工艺参数与质量参数的有机关联与协调,能够很好地保障中药制剂质量的重复性、一致性、稳定性,为企业完善、改进生产工艺,提升中药制剂产品质量提供思路。

Process parameters and quality parameters,established in the forming process of Chinese material medica preparations,are two interrelated elements and restrict with each other.The unity of opposites reflects the role of process control and exhibits the special process of how to transform from raw material drugs into drugs.In this paper,we analyze the process parameters and quality parameters which affect the preparation of traditional Chinese medicine,propose the necessity of establishing the relationship between them,and realize the organic association and coordination of process parameters and quality parameters,ensuring the repeatability,consistency and stability of the quality of Chinese material medica preparations.This article provides ideas for enterprises to improve the production process and the quality of Chinese material medica preparations.