葛根质量评价沿革及其药效组分质量标准研究模式

Historical Evolution of Quality Evaluation of Radix Puerariae and Study Mode for Quality Standard of Active Components Alignment

中药质量优劣的最主要体现就是"疗效",因此中药的质量标准需要能够准确地表述其疗效特征。中药药效组分理论质量标准研究模式以"临床疗效"为核心,依据不同药效物质组合(药效组分)产生不同临床疗效的客观事实展开。采用传统中药葛根为模型药物,综述其质量评价的历史沿革,并在中医理论与中药药效组分理论的指导下,以临床功效为基础,探讨葛根的"标准物质"(药效组分),采用不同药效组分对应不同临床疗效的方法进行分析,建立中药葛根的药效组分质量标准总体研究模式,为中药质量标准的深入研究提供新思路。

The effect embodies the quality of traditional Chinese medicine （TCM）. Therefore, the quality standards of TCM should describe its curative effect characteristics. The active components alignment theory is a new theory. It is based on the objective fact that different efficacy material combinations （active components alignment） produce different clinical curative effect with ＇clinical curative effect＇ as the core. Puerariae is the model medicine in the manuscript. It explores historical evolution of its quality assessment, and looks for authentic ＇standard substance＇ （active components alignment） on the basis of curative effect, under the guidance of active components alignment theory and clinical practice of TCM. Apply the analysis method that clinical effect is corresponding to active components alignment to establish general study mode of quality standard of Radix Puerariae. It provides a new idea and method for further study of quality standards based on clinical curative effect.