The Pharmaceutical Study On Total Alkaloids Suppiository

Kushen Suppository is a highly effective antibiotic drug used widely in the treatment of a variety of gynecological diseases. The principal component of Kushen Suppository is total alkaloids, which is effective position of radix sophorae flavescentis.The purpose of this research project is to enhance the efficiency of extraction process of total alkaloids.We will make a better quality standards of Kushen suppository, and another study will fcous on its extracorporeal releasing characteristic property.In this work, we established a methoed for the extraction process of total alkaloids in radix sophorae flavescentis. Then, a quality standards of Kushen suppository have been made. Another work fcous on testing the stability of this suppository. The results showed that the preparation process is reasonable and feasible, and the quality of product is stable.The content of total alkaloids and the content of matrine and oxymatrine were determined by acid-base titration and HPLC, respectively. The separation was performed on KR100-5NH2, Dimensions:(250mm×4.6mm, Nucleosil). The mobile phase was acetonitrile-ethanol-double distilled water-phosphate bufer solution(80:14:6:0.2). The flow rate was 1.0 ml·min-1. The detection wavelength was 220 nm. The column temperature was 25℃. The average recovery of matrine was 100.14%, with RSD=1.91%, and the average recovery of oxymatrine was 99.94%, with RSD=1.22%.In addtion, the release degree of total alkaloids of Kushen Suppository were determined. The max absorption of combining compounds is at 416 nm, and then it was used to determine the concentration of total alkaloids, to study of in vitro release mechanism. The results showed that what be made a suppository accords with pharmacopoeia suppository in connection with regulation to be released for 30 minutes completely.Linear range is9.87-99.46mg/l, r=0.9998. Average recovery is 99.49%.The in-day precision in one day RSD is 1.85%, and the between-day precision RSD is 2.62%.The study might give more information to the quality standards of Kushen suppository and might be further investigated in our research.