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目的以丙烯酸树脂(Eudragit)为包衣材料,制备泮托拉唑钠(PAZ-Na)肠溶缓释微丸,并对其体外释药性能以及粉体学性质进行考察。方法采用溶液上药法(流化床底喷装置)制备PAZ-Na微丸,用Eudragit RS/RL作为缓释包衣材料,制备缓释微丸;用EudragitL100-55作为肠溶包衣材料,利用微型流化床进行包衣,制备肠溶缓释微丸,并通过单因素实验优化处方及其工艺条件,建立HPLC测定微丸中PAZ-Na,且测定了包衣微丸体外释放度。结果制备的肠溶缓释微丸质量良好,在pH1.2盐酸溶液中2h的释放度<10%;在PBS(pH6.8)中,释放曲线符合一级动力学方程,具有明显的缓释特征。结论PAZ-Na肠溶缓释微丸具有良好的体外缓释效果,制备工艺简单,重现性良好。
OBJECTIVE To prepare the praziquantel sodium (PAZ-Na) enteric coated sustained-release pellets by using Eudragit as coating material, and investigate its in vitro drug release and powder properties. Methods PAZ-Na pellets were prepared by solution method (fluidized bed bottom spray device), and sustained release pellets were prepared by using Eudragit RS / RL as sustained release coating material. Eudragit L100-55 was used as enteric coating material, The microcapsules were coated with micro fluidized bed to prepare enteric sustained-release pellets. The formulation and process conditions of the enteric-coated pellets were optimized by single factor experiments. HPLC was used to determine PAZ-Na in the pellets. The in vitro release of the coated pellets was determined. Results The enteric sustained-release pellets prepared were of good quality with the release of 2h in pH1.2 HCl solution <10%. In PBS (pH6.8), the release curve was in accordance with the first-order kinetic equation with obvious sustained release feature. Conclusion PAZ-Na enteric sustained-release pellets have good sustained-release effect in vitro. The preparation process is simple and the reproducibility is good.