漂浮型脉冲释放胶囊的设计和研制

Design and Preparation of Floating and Pulsatile Drug Delivery Capsules

用灌注法制备非渗透性胶囊体,用湿法制粒法制备含药片和溶蚀塞片。胶囊体内依次装填助漂浮剂氢化蓖麻油、含药片和溶蚀塞片,盖上水溶性囊帽,得漂浮型脉冲释放胶囊。考察了所制胶囊的漂浮性和影响时滞的因素。结果表明,脉冲胶囊的漂浮性能良好,经一定时滞后药物呈脉冲释放。溶蚀塞片、含药片及氢化蓖麻油填料量对胶囊的释药时滞有显著影响。此外,释药时滞还随搅拌速度增大而缩短;释放介质pH对时滞无显著影响。

The impermeable capsule body was prepared by fulfilling method. The drug tablets and erodible plugswere prepared by wet granulation compression. The floating material filler hydrogenated castor oil, the drug tablet anderodible plug were put into the impermeable capsule body, and then covered with water soluble cap to obtain pulsatilecapsules. The floating behavior and influence factors on the lag time of the prepared capsules were investigated. Theresults showed that the capsules had typical floating and pulsatile release properties with a lag time followed by a rapidrelease phase. The erodible plugs, drug tablets and the filling content of hydrogenated castor oil had significant effectson the lag time of the capsules. In addition, the lag time could be shortened by increased the stirring speed, and the releasemedia had no significant effect on it.