挤出滚圆法制备间尼索地平-磺丁醚-β-环糊精微丸及其质量评价  

Preparation and Quality Evaluation of m-Nisoldipine-Sulfobutyl Ether-β-Cyclodextrins Pellets by Extrusion-Spheronization Method

作　　者：齐晓丹[1] 王伟[1] 田珊[1] 

机构地区：[1]河北医科大学药学院药剂学教研室,石家庄050017

出　　处：《中国现代应用药学》2011年第1期60-63,共4页Chinese Journal of Modern Applied Pharmacy

基　　金：河北省自然科学基金资助项目(C2010000488)

摘　　要：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 high solubility m-nisoldipine pellets.METHODS The m-nisoldipine-sulfobutyl ether（SBE）-β-cyclodextrins（CD） pellets were prepared by extrusion-spheronization,ethanol solvent with hydroxypropyl cellulose as a binder.The effects of key parameters on spheronization process were the proportion of extrusion speed and spheronisation speed,which were investigated to obtain optimal formulation.In vitro release of pellets and micromeritics of pellets were evaluated.RESULTS m-Nisoldipine pellets have good water soluble property,presented perfect sphericity and yield over 70%.CONCLUSION The m-nisoldipine-SBE-β-CD pellets are successfully prepared by extrusion-spheronization.It presents a method for poor water soluble drugs pellets.

关 键 词：挤出滚圆 间尼索地平 磺丁醚-β-环糊精 微丸 体外溶出 粉体学 

分 类 号：R943.4[医药卫生—药剂学]