盐酸二甲双胍亲水凝胶骨架片的凝胶强度与漂浮性能评价

Evaluation of Gel Strength and Floatability of Metformin Hydrochloride Sustained Release Tablets

摘要: 目的探索处方和硬度对盐酸二甲双胍亲水凝胶骨架片的凝胶强度与漂浮性能的影响。方法以市售盐酸二甲双胍亲水凝胶骨架片和自制片剂为样品，采用质构仪测定不同时间点缓释片的凝胶强度，以带密度组件的天平测定10 h内缓释片的漂浮力实时数据，并测定溶出度。结果不同处方的盐酸二甲双胍亲水凝胶骨架片溶出度差异较小，聚合物的分子量和硬度对凝胶强度和漂浮性能有较大影响。结论凝胶强度和漂浮性能可以作为盐酸二甲双胍亲水凝胶骨架片体外评价的有益补充。

Abstract: OBJECTIVE To explore the effect of formula and hardness on gel strength and floatability for metformin hydrochloride(MET) sustained release tablets. METHODS Determine the gel strength of MET sustained release tablets in pure water at presupposed time point by texture analyzer and test buoyancy in pure water in 10 h by balance with density subassembly, drug release was also determined. RESULTS The drug release for all MET tablets were similar, molecular weight of polymer and tablet hardness showed significant effect on gel strength and floatability. CONCLUSION The gel strength and floatability test could be used as another in vitro evaluation besides dissolution for MET sustained released tablets.