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.