The Study Of Microporosity Osmotic Pump Tablets Of Baicalin Solid Dispersion

Baicalin is the general term of flavonoids extracted from the roots of scutellaria baicalensis georgi, modern research has found that its pharmacological effects on the antibacterial anti-inflammatory.antihypertensive and dieresis, commonly used in the treatment of acute and chronic hepatitis and hepatitis of chronic defer sex. In view of the long duration of chronic hepatitis and hepatitis of chronic defer sex 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 baicalin. This paper use the method of solid dispersion technology to improve the solubility and dissolution of the baicalin, tnen made it into the microporosity osmotic pump tablets, which can provide a safer, more effective and controllable new agent for the clinical treatment of chronic hepatitis and hepatitis of chronic defer sex.First, the method of UPLC fingerprints of scutellaria baicalensis is established, which providing a specific, accurate and reliable, rapid and comprehensive evaluation method for the quality control of scutellaria baicalensis.About the quality control study of scutellaria extract, investigated by extract characters, fingerprint, inspection, determination of content and other items. And setting the scutellaria extract as an index component, the method of determining release degrees in vitro and UV detection is established. 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 f2 similarity 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 modelFinally, this paper had a quality control study for the preparation, investigated by the extract characters, fingerprint, determination of content and preliminary stability. Preliminary stability resplts show that, the preparation is stable under the condition of high humidity and accelerated testing, and it cannot resist high temperature, should be kept in a dry,shady and closed environment.