卡托普利控释微丸的研制

Preparation of captopril controlled release pellets

目的 :制备卡托普利控释微丸 ,并对其释药情况进行研究。方法 :在流化床内 ,用丙烯酸树脂RL30D和丙烯酸树脂RS30D的混合物作为包衣材料制备卡托普利控释微丸 ,对包衣材料配比及包衣材料用量进行选择 ,对微丸体外释药方程进行研究 ,采用加速试验法考察微丸释药稳定性。结果 :包衣材料最佳配比丙烯酸树脂RL30D 丙烯酸树脂RS30D为 1:5 ,包衣材料最佳用量为包衣增重 2 0 % ,微丸的体外释药方程为Q =0 .0 96 14t- 0 .0 0 8379(r =0 .9980 ) ,释药稳定性好。结论 :卡托普利控释微丸具有良好的零级释药特征。

ABSTRACT:OBJECTIVE To prepare captopril controlled release pellets with Eudragit pseudolatex and to investigate the drug release in vitro.METHODS The captopril controlled release pellets were coated with the mixture of acrylic resin RL30D and acrylic resin RS30D in fluid bed coater.The acrylic resin RL30D/ acrylic resin RS30D ratio and the amount of coating material were selected. The release eqution of pellets was studied. The release stability of pellets was determined by accelerated test process.RESULTS The optimum acrylic resin RL30D/ acrylic resin RS30D ratio is 1:5 and increase of coating material is 20%.The release eqution of pellets is Q = 0.09614t - 0.008379 ( r = 0.9980 )in vitro. The release stability of pellets is good.CONCLUSIONS The release profile of captopril controlled release pellets in vitro is fitted well by zero order release.