基于超分子理论探索古代经典名方的质量控制模式

Research on Quality Control Model of Ancient Famous Classical Formulas Based on Supramolecular Theory

古代经典名方是基于疗效优、毒副作用小、临床上广泛应用的特点进行研发,其发展将切实推动中医药的应用,具有重要的社会效益和经济效益。中药及中药复方是多成分体系,通过多成分、多靶点和多途径作用于人体,其疗效是多成分协同作用的结果,如何在中药多成分的生物学性质基础上,阐述药材-饮片-制剂制备过程及质量属性显得非常关键。中药和人体均是巨复超分子体,其成分是反映原生物体"印迹模板"特征聚集客体,具有遗传多态性。中药质量属性、炮制、制剂制备与质量属性评价都受到超分子化学的影响,最终反映到"印迹模板"的制备及其质量属性的传递规律上。因此,经典名方研发时运用超分子"印迹模板"理论来研究中药生物遗传多态性,以及药材炮制、制剂制备与质量属性评价,可提高研发成功的可获得率。

The ancient famous classical formulas were developed based on the characteristics of excellent curative effect,small toxic and side effects,and wide clinical application.Its development will promote the development of traditional Chinese medicine(TCM) with huge social and economic benefits.TCM and TCM compounds are multi-component systems,which are multi-component,multi-target and multi-pathway effect on human body, their curative effect is the result of synergistic effect of multi-component.Because of its characteristics,its mechanism of action is still unclear and quality is difficult to control.Therefore,on the basis of biological properties of the multi-components of TCM,it is the key issue to study the preparation process of the medicinal materials-decoction pieces-preparations and the transferability,stability and homogeneity of the quality attributes.Moreover,the supramolecular theory can explain the basic theory of TCM from the macroscopic and microscopic aspects,the study of ancient famous classical formulas can use the supramolecular theory.Both TCM and human body are giant complex supramolecules,and their components are clustered objects reflecting the characteristics of the original imprinting template with genetic polymorphism.The quality attributes,processing,formulation preparation and quality attribute evaluation of TCM are all affected by supramolecular chemistry,which is finally reflected in the preparation of imprinting template and the transfer law of quality properties.Therefore,the application of supramolecular imprinting template theory to study the biogenetic polymorphism of TCM,processing,formulation preparation and quality attribute evaluation of medicinal materials can improve the availability rate of successful research and development of ancient famous classical formulas.