Oxymatrine Osmotic Pump

Marine is a mixed alkaloid composed of no less than 98 percent of Oxymatrine(OM) free of water and a very few quantity of Oxysophocarpine. As a base of Lightyellow Sophora root, marine has inhibition effects of central nervous system, such as analgesic action, sedation and hypothermia. Oxymatrine has significant depressurization and antiarrhythmic action, inhibition effect on proliferation of test tumors and is also evidently antagonistic to various acute exudative inflammation. The in vivo and in vitro analytical methods were established, the reliability of which were confirmed through detailed methodological study.The basic physicalchemical properties of OM, drug release performance and drug content of tablets were determined by HPLC, which was proved to be a high-sensitivity, strong-specificity method and can satisfy any analytical requirement in this study correctly and conveniently.To prepare the Marine osmotic-pump controlled release tablets, several character of Marine were examined before prescription. The solubilities of Marine in solutions of different PH and in condition of different osmotic promoter's saturation solution were investigated.On the basis of investigating the characters of Marine and various ingredients, Marine osmotic-pump controlled release tablets were designed and prepared by using sodium chloride (NaCl) as osmotic promoter, lactose as filler, cellulose acetate as coating material, dibutylphthalate(DBP) and polyethylene glycol 6000(PEG 6000) as plasticizer and acetone as coating solvent, coating at the spraying speed of 2.0 mL·min^-1, the temperature of 45 ± 5℃, the coating pan rotate speed of 20 rpm and drilling holes with the diameter of 0.4 mm. At the same time, by means of single-factor tests, the effect of kinds and quantities of the filler, osmotic promoter and plasticizer and the effect of weight addition of tablets owing to the coating films on drug release were researched.Then the character of coating films was studied initially. Such as the influence of plasticizer on the character of coating films, which were prepared by plate spreading, was studied by the water penetration coefficient and weightlessness of coating films after soaking. According to the visual pictures obtained by the scanning of digital microscope, the release mechanism of . In conclusion, the temperature of coating had significant effect on the character of coating film.