吲达帕胺缓释胶囊的制备及体外释放度考查

目的:制备吲达帕胺缓释胶囊及考查体外释放特性。方法:以空白丸芯、柠檬酸三乙酯、滑石粉、硬脂酸镁、胶体二氧化硅、聚维酮K30等为骨架材料制备吲达帕胺缓释胶囊;采用高效液相色谱法建立含量测定方法,通过释放度试验评价缓释效果。结果:本品在0.01 mol/L盐酸溶液中可持续释药24 h,其释放规律符合Higuchi方程;前12 h平均累计释放度与时间呈良好线性关系,3批样品与进口吲达帕胺缓释片释放曲线基本一致。结论:本品处方合理,制备工艺简单,体外缓释效果明显。

Preparation and in vitro release of indapamide sustained-release capsules

Object: To prepare indapamide sustained-release capsules and investigate its release in vitro.Methods: Using eudragitrs 100,triethyl citrate,hydrated magnesium silicate,magnesium stearate,silicic acid anhydride,povidone K30 and etc as capsules preparation materials.The content was determined by HPLC at 240 nm.The sustained-release effects of capsules were evaluated by release test. Results: The capsules releasing time lasted for 24 hours in 0.01 mol/L of hydrochloric acid and the releasing feature was fitted to Higuchi equation.Conclusion: The formulation with significant sustained-release effect in vitro is rational and the preparation method is simple.