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目的考察不同缓释骨架材料对右旋布洛芬缓释双层片的体外释放度影响及体外释药模型、机制研究。方法采用紫外-可见光分光光度法检测不同骨架材料右旋布洛芬缓释双层片中主药的释放度。结果通过比较释放度-时间曲线评定各骨架对制剂释放度的影响,得到最佳骨架种类及比例,即右旋布洛芬-羟丙基甲基纤维素K4M-聚丙烯酸树酯Ⅱ为9∶1∶3。该最佳比例杂化骨架右旋布洛芬缓释双层片为一级释放,且为药物扩散与骨架溶蚀协同作用。结论结合体外释放度及体内药动学数据,本品右旋布洛芬缓释双层片具有起效快、药效持久、稳定等特点,明显优于普通制剂或一般缓释制剂,最大限度发挥临床疗效。
Objective To investigate the effect of different sustained-release matrix materials on in vitro release of dexibuprofen sustained-release bilayer tablets and its in vitro release model and mechanism. Methods UV-visible spectrophotometry was used to determine the drug release of dexibuprofen sustained-release bilayer tablets with different matrix materials. Results By comparing the release-time curves, the influence of each skeleton on the drug release was evaluated, and the best skeletal types and ratios were obtained, that is, dexibuprofen-hydroxypropyl methylcellulose K4M-polyacrylate II was 9: 1: 3. The optimal ratio of hybrid framework dexibuprofen sustained release bilayer tablets for the first-order release, and synergistic effect of drug diffusion and skeleton erosion. Conclusion Combined with in vitro release and in vivo pharmacokinetic data, the sustained-release double-layered tablets of dexibuprofen has the characteristics of quick onset, long-lasting efficacy and stability, which is obviously better than the ordinary or general sustained release formulations, To play a clinical effect.