经典名方复方制剂研发的文献考证要点与策略

Key Points and Strategies of Textual Research in Development of Famous Classical Formulas

文献考证是经典名方复方制剂研发的第一步,是确保经典名方制剂临床应用安全性和有效性的重要环节,是确定研发方案、选择实验参数指标的主要依据之一,其中就涉及到处方的来源及历史沿革、功用主治、方义、煎服法以及组成药味的基原部位、产地、用量、炮制方法等要点。针对这些要点,笔者认为应按照规范的流程和方法全面、准确地收集古今文献信息;结合历史年代沿续和横断面分析方法进行考证;以保障中药复方制剂的疗效、安全性为出发点,从中医药理论特点、方药历史演变、现代临床价值和现实可行性角度综合权衡制定研发方案;应在'遵古'的前提下,用历史和发展的角度去认识研发过程中的中药基原、炮制、剂量、煎服法等共性问题,广泛凝聚行业共识,共同发掘好经典名方这一宝贵财富。

Textual research is the first step,ensuring the safety and effectiveness of the clinical application,and also one of the main bases for determining the research scheme and experimental parameters in the development of famous classical formulas.It involves the origin and historical evolution of the prescription,the main function,the meaning of the prescription,the decoction method,as well as the original part,origin,dosage,processing method of the medicinal materials in the prescription.In view of these points,the author believes that the ancient and modern literature information should be comprehensively and accurately collected according to the standardized procedures and methods,combined with the historical continuation and cross-sectional analysis,in order to ensure the efficacy and safety of traditional Chinese medicine(TCM)famous classical formulas.The research and development plan of famous classical formulas was formulated from the perspectives of TCM theoretical characteristics,formula historical evolution,modern clinical value and practical feasibility.Under the premise of'compliance with the ancients',we should understand the common problems in the process of research and development,such as the origin,processing,dosage and decoction of TCM from the perspective of history and development,so as to widely gather the industry consensus and jointly explore the precious treasure of the famous classical formulas.