泮托拉唑钠肠溶微丸的制备

Preparation of Pantoprazole Sodium Enteric-coated Pellets

以泮托拉唑钠、羟丙甲纤维素、无水碳酸钠、吐温-80、十二烷基磺酸钠和水混合制成主药层包衣溶液。采用流化床包衣技术,对空白丸芯依次包主药层、隔离层和肠溶层,制得泮托拉唑钠肠溶微丸,并优化了处方和工艺。将所得肠溶微丸装入普通胶囊中制成泮托拉唑钠肠溶微丸胶囊,3批制品在pH6.8磷酸盐缓冲液中45min时的释放度分别为(97.6±1.1)%、(98.1±1.3)%、(98.4±1.9)%,在0.1mol/L盐酸中2h时的释放量分别为(2.9±1.7)%、(2.9±1.4)%、(2.3±2.1)%。

The drug layer coating solution was made by mixing pantoprazole sodium, HPMC, anhydrous sodium carbonate, Tween-80 and sodium lauryl sulfate with water. The blank pellets were consecutively coated with the drug layer, insulation layer and enteric layer to obtain pantoprazole sodium enteric-coated pellets in fluidized bed. The preparation was optimized. The pantoprazole sodium enteric capsules were prepared by encapsulating enteric- coated pellets into hard gelatin capsules. The accumulative release of three batches of the capsules in pH 6.8 phosphate buffer solution at 45 min were （97.6±1.1） %0, （98.1±1.3） % and （98.4±1.9） %, respectively. The accumulative release in 0.1 mol/L hydrochloric acid at 2 h were （2.9±1.7） %, （2.9±1.4） % and （2.3±2.1） %, respectively.