【摘要】 目的基于缓控释技术制备布洛芬双层片,并探讨其释放机制。方法采用高效液相色谱法建立布洛芬体外分析方法,分别以溶出度、释放度为考察指标,优化布洛芬速释缓释双层片的制备工艺;采用数学模型进行拟合,探讨双层片缓释层的释放机制。结果高效液相色谱法测定布洛芬含量稳定可行。通过比较溶出度—时间曲线、释放度—时间曲线评定各辅料对溶出度、释放度的影响,确定各辅料的最佳种类及用量,筛选最优处方;在释药机理研究中,释药行为符合Ritger-Peppas模型方程。结论基于缓控释技术的布洛芬速释缓释双层片制备工艺简单,速释层增加布洛芬的溶解度,缓释层维持了有效的血药浓度,提高生物利用度,减少了服用次数,适合大工业生产。更多还原

【Abstract】 Objective To prepare ibuprofen bi-layer tablets based on controlled release technology and to explore its release mechanism. Methods The in vitro analysis method of ibuprofen was established by high performance liquid chromatography. The dissolution and release were used as indicators. The preparation process of ibuprofen immediate release slow release double-layer tablets was optimized. The mathematical model was used to fit the release mechanism of the two-layer sustained-release layer. Results The determination of ibuprofen content by high performance liquid chromatography was stable and feasible. By comparing the dissolution-time curve and the releasetime curve, the effects of each excipient on dissolution and release were evaluated. The best type and dosage of each excipient were determined, and the optimal prescription was screened. In the study of drug release mechanism, release behavior conforms to the Ritger-Peppas model equation. Conclusion The preparation process of ibuprofen immediate release slow release bi-layer based on slow release technology is simple, the immediate release layer increases the solubility of ibuprofen, and the sustained release layer maintains an effective blood concentration. Improve bioavailability and reduce the number of doses, suitable for large industrial production.更多还原