吲达帕胺缓释胶囊的制备及体外释放度考查

Preparation and in vitro release of indapamide sustained-release capsules

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。

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 sustainedrelease effect in vitro is rational and the preparation method is simple.