Study On The Huaihuai Capsule Preparation And The Quality Control

The Maackia amurensis capsule was made from the extraction of crude drug Maackia amurensis.In this study, the optimum extraction technology of the effective components of the raw material was studied. The experiment was designed according to orthogonal tests which contained five factors—the ethanol concentration, the extraction time, the extraction times, the extraction temperature and the ethanol quantity, and the content of genestin was regarded as evaluation index to optimize the extraction tcchnology. We also studied the hydrolysis technology, the hrdrolysis experiment was designed according to orthogonal tests, too, which contained three factors—the hydrochloride concentration, the hydrolysis time and the hydrolysis temperature, and the content of formononetin was chosen as marker to optimize the hydrolysis techology.By using the growth factor of the young rats’uterus, we studied the pharmacodynamics of the products of hydrolysis, make sure the effectiveness of the hydrolysis products and determine the best oral amount of the products.By adding suitable bulking agent, disintegrating agent, and lubricant to the hydrolysis product, preparation technology of Maackia amurensis capsule was established.Reverse-phase HPLC methods have been developed for the determination of the three isoflavone aglycones, and the quality control criterion of the capsule was initially established.