含果胶盖塞型脉冲胶囊的制备及体外释放研究

Study on Pectin Containing Capsular Shaped Pulsatile Drug Delivery System

目的制备以果胶为主要控释材料的盖塞控制型脉冲胶囊给药系统。方法用灌注法制备非渗透性胶囊体,粉末直接压片法压制盖塞片,湿法制粒制备含药速崩片,将速崩片用盖塞片密封于非渗透性胶囊体内制备脉冲塞胶囊,对其体外释药行为进行评价。结果盖塞片的处方组成和重量能显著影响脉冲胶囊的释药时滞。释药时滞随盖塞片中果胶和果胶酶比例、果胶和乳糖的比例以及片重的增加而增加。结论通过调节盖塞片的处方组成和重量可获得具有适当时滞的脉冲给药系统。

OBJECTIVE To develop a novel pulsatile drug delivery system with the lag time controlled by a plug tablet mainly made of pectin. METHODS The impermeable body was prepared by fulfilling method. The plug tablet was made by direct compression and the drug tablet was made by wet granulation. The pulsatile capsule was prepared by sealing the drug tablet inside the impermeable capsule body with the plug tablet. The influence factors on the lag-time such as the composition and the weight of the plug tablet were investigated by dissolution testing. RESULTS Both the composition and the weight of the plug tablet significantly influenced the lag-time.The lag-time was extended with the increased weight of plug tablet or the increased pectin proportion. CONCLUSION A pulsatile drug delivery system with a suitable lag-time can be achieved by adjusting the composition and weight of plug tablet.