基于“组分结构”特征的中药制剂质量评价策略

Quality evaluation strategy of Chinese materia medica preparation based on characteristics of “structural composition of multi-components”

中药制剂质量的科学客观评价一直是中药现代化进程中普遍存在的历史性难题。既往中药制剂质量评价多采用'以点代面,以一代全'的单成分评价模式及'唯含量论'的指标选取方式,严重偏离了中药整体观的特点,难以客观准确地评价中药制剂质量。目前,基于多指标的中药制剂质量评价模式已成为众多专家学者的共识,然而中药多成分的复杂性,使其无法实现所有成分的准确辨识,更不可能将所有成分作为中药制剂质量评价的标准。结合中药自身特点,提出在现有药效物质基础研究的基础上,借助网络药理学、分子对接等先进技术手段,选取可代表中药制剂整体效应的有限个代表性成分,并在各代表性成分量比关系考察的基础上,以代表性成分的量及各代表性成分间量的关系为参数,建立基于'组分结构'特征的中药制剂质量评价策略,以期为今后中药制剂质量评价提供新的思路。

The scientific and objective quality evaluation of traditional Chinese medicine preparations has always been a historical problem in the process of modernization of traditional Chinese medicine.In the past,the single component evaluation model of'point for surface,one for all'and the index selection method of'content-only theory'were mostly used in the quality evaluation of traditional Chinese medicine preparations,which seriously deviated from the characteristics of the overall view of traditional Chinese medicine,and it was difficult to objectively and accurately evaluate the quality of traditional Chinese medicine preparations.At present,the quality evaluation model of traditional Chinese medicine preparations based on multiple indicators has become the consensus of many experts and scholars.However,the complexity of the multi-components of traditional Chinese medicines has made it impossible to accurately identify all the components in the quality evaluation of traditional Chinese medicine preparations,and it is even more impossible to use all the components as the standard for quality evaluation.According to the characteristics of traditional Chinese medicine,a limited number of representative components which can represent the overall effect of traditional Chinese medicine preparations were selected by means of network pharmacology,molecular docking,etc.Based on the content of representative components and their proportional relationship,the quality evaluation strategy of traditional Chinese medicine preparation based on the characteristics of'components structure'was established,in order to provide new ideas for the quality evaluation of traditional Chinese medicine preparations in the future.