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目的制备具有较高水溶性的间尼索地平微丸。方法以磺丁醚-β-环糊精(SBE-β-CD)为成丸辅料,羟丙基纤维素乙醇溶液为黏合剂,采用挤出滚圆法制备间尼索地平微丸,对影响成球的关键参数挤出速度、滚圆转速进行筛选优化,对微丸体外释放进行评价,并对微丸进行粉体学性质的考察。结果制得的间尼索地平微丸水中溶出度高,圆整度好,收率可达70%,各项粉体学性质较为理想。结论以SBE-β-CD为成丸辅料,采用挤出滚圆法制备高水溶性的间尼索地平微丸在工艺上是可行的,对难溶性药物微丸的制备具有一定借鉴作用。
Objective To prepare nisoldipine pellets with high water solubility. Methods SBE-β-cyclodextrin (SBE-β-CD) was used as pellet excipient and hydroxypropyl cellulose ethanol solution was used as binder to prepare nisoldipine pellets by extrusion spheronization. The key parameters of the ball extrusion speed, rounding speed screening optimization of the release of micro-pellets in vitro evaluation, and pellets for powder properties of the study. Results The prepared nisoldipine pellets had high dissolution rate and good roundness in water, and the yield was up to 70%. The properties of the powders were ideal. Conclusion SBE-β-CD as pellet excipients, extrusion spheronization preparation of high water-soluble m-nisoldipine pellets in the process is feasible, for the preparation of insoluble drug pellets have a certain reference.