The Study Of Microporosity Osmotic Pump Tablet Of Suberectus Spatholobus Total Flavonoids Solid Dispersion

Suberectus spatholobus total flavonoids, is the general term of flavonoids extracted from the cane of spatholobus suberectus dunn, modern research has found that its pharmacological effects on the blood system, circulatory system, and immune system, commonly used in the treatment of pancytopenia, aplastic anemia. In view of the long duration of aplastic anemia that needing long-term medication features, based on common preparation, this paper carry on the study of preparation process and quality standard of microporosity osmotic pump tablets of suberectus spatholobus total flavonoids. This paper use the method of solid dispersion technology to improve the solubility and dissolution of the suberectus spatholobus total flavonoids, then made it into the microporosity osmotic pump tablets, which can provide a safer, more effective and controllable new agent for the clinical treatment of leukopenia and aplastic anemia.First, the method of UPLC fingerprints of caulis spatholobi is established, which providing a specific, accurate and reliable, rapid and comprehensive evaluation method for the quality control of caulis spatholobi.About the quality control study of suberectus spatholobus total flavonoids, investigated by extract characters, fingerprint, inspection, determination of content and other items. And setting the suberectus spatholobus total flavonoids as an index component, the method of determining release degrees in vitro and UV detection is established. Then establish a HPLC method for determination of catechin, epicatechin. All these lay a foundation for prescription screening and quality evaluation of preparation.Then investigate the influence of various factors, including the type and amount of carrier, the method for preparing, then selected the best prescription to prepare the ideal solid dispersion. Using single-factor test method to investigate the influence on the drug release, including the types of fillers, the types and dosage of penetration enhancers, the dosage of porogen (PEG400), the dosage of plasticizer(DBP), and the thickness of the coating. This paper adopt f2similarity factor method to judge the similarity of the release behavior of osmotic pump tablets in vitro, screened the main factors was the dosage of sodium chloride and PEG400. and the thickness of the coating. In this paper, optimize the formulation by a central composite design-response surface methodology, and fit the the optimum formulation with zero-order release model, the first-order release model and the Higuchi release model. The results show that the drug release curve with zero order model. Finally, this paper had a quality control study for the preparation, investigated by the extract characters, fingerprint, determination of content and preliminary stability. Preliminary stability results show that, the preparation is stable under the condition of high temperature, high humidity and accelerated testing, and it has a certain amount of hygroscopic, should be kept in a dry and closed environment.