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目的:制备卡维地洛微孔渗透泵颗粒,并对其性能进行研究。方法:以卡维地洛作为模型药物,以氯化钠为渗透压活性物质,酒石酸为溶解度调节剂,醋酸纤维素为包衣膜材,PEG400为水溶性致孔剂,采用正交试验设计法L9(34)优选卡维地洛微孔渗透泵颗粒制备工艺。结果:卡维地洛微孔渗透泵颗粒在模拟胃肠环境中按零级动力学方式释放药物,具有明显的渗透泵特征和控释效果,且基本不受胃肠pH环境的影响,12 h内累积释放度可达71.90%。结论:卡维地洛微孔渗透泵颗粒处方组成合理、制备工艺可行,可望成为一种新的卡维地洛控释剂型。
Objective: To prepare carvedilol microporous osmotic pump particles and study its properties. Methods: Carvedilol was used as a model drug, sodium chloride as osmotic pressure active substance, tartaric acid as solubility regulator, cellulose acetate as coating material, and PEG400 as water-soluble porogen. Orthogonal design L9 (34) preferred carvedilol microporous osmotic pump particle preparation process. Results: Carvedilol microporous osmotic pump particles released drugs in a modeled gastrointestinal environment in a zero-order kinetic manner with obvious osmotic pump characteristics and controlled release effect, and were basically independent of the gastrointestinal pH environment. After 12 h Within the cumulative release of up to 71.90%. Conclusion: Carvedilol microporous osmotic pump particles prescription composition is reasonable, the preparation process is feasible, is expected to become a new type of carvedilol controlled release.