泮托拉唑钠肠溶微丸胶囊的制备

Preparation of the enteric-coated pellets of pantoprazole sodium

以泮托拉唑钠、聚乙烯吡咯烷酮、滑石粉、磷酸钠、磷酸氢二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pH 6.8磷酸盐缓冲液中30 min时释放度分别为91.74%、87.98%、88.31%,在0.1 mol/L盐酸中2 h时的耐酸力分别为98.71%、97.18%、101.5%。

The drug layer coating solution was made by mixing pantoprazole sodium, PVP, TALC, sodium phosphate and sodium hydrogen phosphate with water. The blank pellets were consecutively coated with drug layer, insulation layer and enteric layer to obtain pantoprazole sodium enteric-coated pellets in fluidized bed. Meanwhile, the formulation and process were 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 at 30 min were 91.74%, 87.98% and 88.31% and their acid tolerance rates in 0.1 mol/L hydrochloric acid at 2 h were 98.71%, 97.18%a nd 101.5%, respectively.