三黄泻心汤胃内滞留片的制备工艺及质量评价的初步研究OA

Objective:This study aims to develop a Sanhuang gastric retention tablet.By employing modern formulation technology,the active components of Sanhuang Xiexin Decoction are prepared into a solid dosage form.This process preserves the efficacy while achieving sustained release and gastric retention,thereby enhancing its therapeutic effect on gastric ulcers.Methods:In this study,these tablets were prepared by direct powder compression.A single-factor test was employed to investigate the type and amount of matrix materials,floating aid agents,and foaming agents,using floating performance and cumulative drug release as evaluation indica-tors.An orthogonal experimental design was further applied to optimize the formulation.Preliminary quality evaluation and a study on the drug release mechanism of the prepared Sanhuang gastric-retentive tablets were conducted.Results:The optimal formulation was determined as follows:30％HPMC K15M,5％NaHCO3,15％stearyl alcohol,5％microcrystalline cellulose,5％polyethylene gly-col 6000,1％magnesium stearate,and 39％Sanhuang drug.The tablet's weight was 0.35 g.The prepared Sanhuang gastric-retentive tablets exhibited buoyancy within one minute,with an average sustained floating duration of 12 h.Moreover,they demonstrated signifi-cant sustained-release characteristics,achieving a cumulative drug release of over 80％at 12 h.The in vitro drug release profile fitted the Ritger-Peppas model,indicating a release mechanism combining diffusion and erosion.Conclusion:The developed Sanhuang gas-tric retentive tablets exhibit a short floating lag time,prolonged sustained floating duration,and pronounced sustained-release proper-ties.