Objective: Explore safety and effectiveness of medicine in clinical and reasonableness of content limitation to evaluate quality of various Chinese materia medica by berberine hydrochloride as reference substance

and propose an attention to establish quality specification corresponding to the clinical effects. Method: Berberine hydrochloride was determined by HPLC

and he safety and effectiveness in clinical and rationality of quality indexes were discussed by comparing assay and effect in intervention levels of traditional decoction

drugs compatibility and veritaserum. Result: Content of berberine hydrochloride was:(5.52%±0.065%)-(0.12%±0.007%) in the solution extracted traditional decoction

drugs compatibility and veritaserum of Rhizoma Coptidis Chinensis

(3.39%±0.065%)-(0.13%±0.005%) in the solution extracted traditional decoction

drugs compatibility and veritaserum of Cortex Phellodendri Chinensis. Conclusion: Chinese materia medica is the active components alignment

and the reference standard to evaluate Chinese materia medica should be the active components alignment. The content of berberine hydrochloride is lower than the current standard in clinical

and the dose in clinical would lead to effectiveness and safety problem. So should pay attention to the counterparts with the specification of single component in the active components alignment and its clinical effects.