CAJ | 학술논문

目的：：制备盐酸倍他司汀缓释骨架片。方法：采用亲水性高分子材料HPMC为骨架，制备盐酸倍他司汀缓释片，并用单因素试验考察其释药特征。正交试验优化处方工艺。结果：以60% HPMC K15M为骨架材料，磷酸氢钙为填充剂，用10%PVP的90%乙醇溶液为黏合剂，湿法制粒压片为最佳工艺，片重为500 mg。药物体外释放接近Higuchi模型，能实现药物12 h内缓慢释放。结论：本品制备工艺简便，具有缓解特性。
목적：：제비염산배타사정완석골가편。방법：채용친수성고분자재료HPMC위골가，제비염산배타사정완석편，병용단인소시험고찰기석약특정。정교시험우화처방공예。결과：이60% HPMC K15M위골가재료，린산경개위전충제，용10%PVP적90%을순용액위점합제，습법제립압편위최가공예，편중위500 mg。약물체외석방접근Higuchi모형，능실현약물12 h내완만석방。결론：본품제비공예간편，구유완해특성。
Objective: To prepare betahistine dihydrochloride sustained-release matrix tablets. Methods: The tablets were pre-pared with water soluble HPMC matrix, and the release behaviors were investigated by single factor study. The formula and preparation procedures were optimized by orthogonal design. Results:The optimal technology was as follows:using 60% HPMC K15M as the ma-trix material, calcium hydrogen phosphate as the filler, 10% PVP in 90% alcohol as the bonding agent;wet granulation compression technique was used to prepare the tablets with the tablet weight of 500mg. The in vitro drug release fits a Higuchi equation and the drug can be sustained-released within 12 h. Conclusion:The preparation technology is simple and the tablets have sustainol release behav-ior.