E Has Developed Gastric Floating Sustained Release Tablets

Objective:Study extraction technology, refining process of Coptis chinensis Franch, euodia ruticarpa, and white paeony root, and study the releasing properties and mechanism in vitro of the active ingredients of the wuji gastric floating sustained-release tablets, Setting up quality standards so as to provide evidence for study to frame type sustained release preparation of chinese herbal compound.Mothods:1.To establish a HPLC method for the determination active components of Coptis chinensis Franch, euodia ruticarpa, and white paeony root.2.According to the effective component properties of each herb, taking different project plans.3.Orthogonal test optimization optimal preparation prescription. fitting equation combined with similar factor to study multicomponent in vitro release behavior of wuji gastric floating sustained release tablets.4. γ-ray camera technology to study retention time of tablets.5. study quality standard of sustained-release tablets with TLC and HPLC.Results:1. HPLC system consisted of four components is Thermo-ODS2-Hyper-sil column(250mm×4.6mm,5um). coptis:the mobile phase was acetonitrile-0.05mol·L-1potassium phosphate(50:50). wave length of UV detector was at345nm, Evodia:the mobile phase was [acetonitrile-tetrahydrofuran(25:15)]-0.05%phosphoric acid, wave length of UV detector was at220nm, white peony root:the mobile phase was acetonitrile-phosphoric acid (14:86). wave length ofUV detector was at230nm, Wuji pellet:the mobile phase was acetonitrile-0.05mol·L-1potassium phosphate, wave length of UV detector was at225nm.2.Choice of Coptis chinensis Franch extraction technology is12time of50%ethanol, extrcting3times, refining technology is polysulfone membrane with5000interception molecular weight had better separation efficiency and the preferred operation parameters were40℃of liquid temperature,and40L·min-1of liquid speed.25g·L-1of liquid concentration; euodia ruticarpa extraction technology is16times of70%ethanol, refining technology is The erude produets were purified by dissolving with ethanol and precipitating gradually with adding wate; white paeony root extraction technology is12time of warer, refining technology is water extraction solution to concentrate relative density1.10～1.15, adding to ethanol in extraction solution so as to concentration attain60%.3.The combined optimum pharmaceutical formulation has been found which was35%HPMC、5%PEG6000、10%sodiumbicarbonate.15%setanol、10%MCC and25%main drug, The cumulative release rate of all the four ingredients fitted Higuchi equation. The similar factors of the cumulative release curve of berberine hydrochloride, evodiamine and rutaecarpin were more than50, indicating that the release of the three ingredients were similar, paeoniflorin was less than50. it indicate that structure is similar to the similar release curve.4. the tablet can retain6huors in the stomach of rabbit.5.quality standard can control its quality.Conclusion:The wuji gastric floating sustained-release tablets have the slow-release characteristics and comply with the requirements of formulation design. Provide theory reference for the study of traditional compound sustained release preparation.