中文摘要：

目的：制备雷贝拉唑钠肠溶微丸。方法：采用挤出滚圆-流化床包衣法制备雷贝拉唑钠肠溶微丸。以微丸休止角、收率及释放度为指标,以微晶纤维素、甘露醇、乳糖加入量和聚乙二醇6000（PEG6000）水溶液的浓度为因素,采用正交试验筛选微丸丸芯的最优处方。以含量和释放度为指标,筛选隔离层包衣增质量;以耐酸力和释放度为指标,筛选肠溶层包衣增质量。对最优处方工艺进行验证,比较其与市售肠溶片和胶囊的耐酸力和释放度。结果：丸芯最优处方为微晶纤维素30%、甘露醇20%、乳糖15%、PEG6000水溶液的浓度15%,雷内拉唑钠10%,隔离层包衣增质量为10%,肠溶层包衣增质量为10%;所制3批样品的丸芯休止角为16.93-17.17°、收率为65.24%-67.36%、样品含量为96.7%-99.9%,耐酸力为99.66%-99.85%、30 min释放度为90.13%-93.62%;与市售肠溶片和肠溶胶囊的耐酸力相当,释放度介于二者间。结论：成功制得雷贝拉唑钠肠溶微丸,且质量稳定、可控,制备工艺简单。

英文摘要：

OBJECTIVE：To prepare Rabeprazole sodium enteric-coated pellets. METHODS： Extrusion-spheronisation and air-flow coating method were used to prepare Rabeprazole sodium enteric-coated pellets. Using angle of repose,yield and release rate as index,the amount of microcrystalline cellulose,mannitol and lactose,the concentration of polyethylene glycol 6000（PEG6000）solution as factors,the formulation of pellet core was optimized by orthogonal test. The weight gain of isolated layer coating was screened using content and release rate as index;that of enteric layer was screened using acid resistance and release rate as index. The optimal formulation was validated,and prepared pellet was compared with commercial enteric-coated tablet and capsule in respects of acid resistance and release rate. RESULTS：The optimal formulation of pellet core was as follows as microcrystalline cellulose 30%,mannitol 20%,lactose 15%,PEG6000 solution 15%,rabeprazole sodium 10%,weight gain of isolated layer10%,weight gain of enteric-coated layer 10%. The angle of repose,yield,content,acid resistance and 30 min release rate of 3batches of samples were 16.93-17.17 °,65.24%-67.36%,96.7%-99.9%,99.66%-99.85% and 90.13%-93.62%,respectively. The acid resistance of sample was similar to that of commercial enteric-coated tablet and capsule,and release rate of sample was in between them. CONCLUSIONS：Rabeprazole sodium enteric-coated pellets are prepared successfully,they are stable and controllabe in quality and simple in preparation technology.