成都中医药大学学报2026，Vol.49Issue(4)：40-50,11.DOI:10.13593/j.cnki.51-1501/r.2026.04.007
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
Research on Preparation Process and Preliminary Quality Evaluation of Sanhuang Xiexin Gastric Retention Tablets
摘要
Abstract
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.关键词
三黄泻心汤/胃内滞留片/正交试验/缓释片Key words
Sanhuang Xiexin decoction/Gastric retentive tablet/Orthogonal design/Sustained-release tablet分类
医药卫生引用本文复制引用
刘欣雨,白芮夕,吴学渊,刘宇彤,王浩,王潇,李文,韩丽..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[J].成都中医药大学学报,2026,49(4):40-50,11.基金项目
国家自然科学基金青年科学基金项目(81903812) （81903812）
四川省自然科学基金(2025ZNSFSC0599) （2025ZNSFSC0599）
四川省中医药管理局项目(2023MS532) （2023MS532）
成都中医药大学"杏林学者"青基人才专项(QJRC2023017) （QJRC2023017）
