挤出滚圆-流化床包衣法制备雷贝拉唑钠肠溶微丸

发布时间：2018-04-27 18:57

本文选题：雷贝拉唑钠 + 肠溶微丸　；参考：《中国药房》2016年04期

【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。
[Abstract]:Objective: to prepare Rabeprazole sodium enteric pellets. Methods: Rabeprazole sodium enteric pellets were prepared by extrusion round-fluidized bed coating method. The optimal formulation of microcrystalline cellulose, mannitol, lactose and PEG6000) solution was studied by orthogonal test, taking the angle of repose, yield and release degree of pellet as the index, and the concentration of microcrystalline cellulose, mannitol, lactose and PEG6000) as the factors. With the content and release degree as the index, the coating quality of the isolation layer was screened, and the acid tolerance and the release degree were used as the indexes to screen the coating quality of the intestinal coated layer. The optimum prescription process was verified and compared with that of enteric coated tablets and capsules. Results: the optimum formulation of the pill core was as follows: microcrystalline cellulose 30, mannitol 20, lactose 15 and PEG6000 water concentration 15, Reneprazole sodium 10, isolation coating 10, intestinal dissolved coating 10, the core angle of the three samples 16.9317.17 掳. The yield was 65.24 and 67.36.The content of the sample was 96.70.99. 9, and the acid tolerance was 99.6685 and 99.85. The release rate for 30 min was 90.13and 93.62um, which was comparable to the acid tolerance of the enteric-coated tablets and enteric-coated capsules sold on the market. The release rate was between the two. Conclusion: Rabeprazole sodium enteric pellets are successfully prepared, with stable quality, controllable quality and simple preparation process.
【作者单位】：中国药科大学药学院;
【基金】：江苏省高等学校大学生创新创业训练计划项目(No.J1030830)
【分类号】：TQ463

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