Study On Preparation Process And Quality Standard Of The Patch Of Total Alcaloids From Sophora Flavescens

It is believed in the << Shennong's Herbal Classica> that the cardiovascular system's function of Sophora flavescens is to treat the jieqi of heart and abdomen. And the < told that using the taste of Sophora flavescens, bitter to heart and cold being able to get rid of fire, so it specializes in the fire of heart meridian. And modern medicine makes much more progress, it believes that alcaloids from Sophora flavescens has the function of strengthening heart, opposing arrhythmia, decreasing blood pressure and expanding coronary artery.This thesis mainly carries out study on the preparing technique, middle test enlargement and quality standard of the patch, which is the matrix diffusion controlled TTS whose main effective component is total alcaloids from Sophora flavescens. The result of the experiment indicated that the product contains very good property to be controlled in quality and the possibility to be manufactured in a large scale.Total alcaloids contents of both extract and patch were analyzed by acid-alkali titration .The result of experiment indicated that this method could effectively monitor the total alcaloids content of extract and patch. In the experiment of middle test enlargement, the average content of the total alcaloids from Sophora flavescens in various batches of the extract is above 80 percent, the average content of total alcaloids in various batches of patches is above 11.98 percent.Meanwhile, Matrine and Oxymatrine of both extract and patch were analyzed by HPLC. The result indicated: (1) Obviously, Oxymatrine had conversed into Matrine during the purification of the total alcaloids, and the rate of conversion was more than 46.77 percent. (2) This method could be used as the standard of quality control because of its good reproducibility and stability.Moreover, improved Franz diffusion pool method was employed to make experiment of liberation degree in vitro, the result shows the liberation ofthe patch of total alcaloids from Sophora flavescens increased as time goes by, which corresponded to Higuchi equation, the regression equation of which is Q=l 77.66+253.97t1/2, r=0.9925, and it makes clear that this preparation belongs to the skeletal transdermal TDD system.