吲达帕胺微孔渗透泵片的制备与体外释药机制研究

目的制备吲达帕胺微孔渗透泵片剂并研究其体外释药机制。方法通过外观观察,测定不同衣膜、片芯、介质等条件变化时的体外释放度,考察其释药机制。结果吲达帕胺微孔渗透泵片体外释药行为符合零级释药模型;不同衣膜、片芯和渗透压介质对药物释放有显著影响;释放介质的pH值、溶出方法和转速对药物释放无显著影响。结论该片剂的释药动力主要为衣膜内外的渗透压差,药物在渗透压驱动下经微孔释药。

Preparation of indapamide Micro-porous Osmotic Pump Tablets and its release mechanism in vitro

Objective To prepare Indapamide Microporous Osmotic Pump Tablets （INDP MPOPT） and to study their in vitro release mechanism. Methods The in vitro release was determined with different coat films, tablet cores, release medium, and other changes in conditions, and the mechanism of release was studied. Results The in vitro release behavior of INDP MPOPT complied with zero order release rule. Different clothes film, cores, and osmotic pressures had significant influence on drug release. While the pH value of dissolution medium, dissolution method, and rotation speed had less effect. Conclusion The release kinetics derives from the difference of the osmotic pressure across the membrance and drug release is through the micropores in the coat film.