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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。
Objective To prepare indapamide microporous osmotic pump tablets and study its in vitro drug release mechanism. Methods By observing the external appearance, the release in vitro of different membrane, core and medium were measured and the mechanism of drug release was investigated. Results The in vitro release behavior of indapamide micro-porous osmotic pump tablets was consistent with the zero-order drug release model. Different drug films, cores and osmotic media had significant effects on the drug release. The release media pH, dissolution method and speed No significant effect of release. Conclusion The release kinetics of this tablet is mainly due to the osmotic pressure difference between inside and outside of the film, and the drug is delivered via micropores under osmotic pressure.