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目的制备扎来普隆脉冲释放微丸,并对其进行处方筛选与优化。方法以交联羧甲基纤维素钠(CC-Na)为内包衣溶胀层,乙基纤维素水分散体为外包衣控释层制备扎来普隆脉冲释放微丸,考察处方因素及介质pH对药物释放的影响,用Box-Behnken效应面设计法对处方进行优化。结果溶胀层厚度、组成及控释层包衣增重对微丸的时滞和释药速率均有显著影响。结论按Box-Behnken效应面设计法所得最优处方制备的微丸具有良好的延时脉冲释药效果。
Objective To prepare zaleplon pulse-releasing pellets and prescribe them for optimization. Methods CCL was used as inner coating swellable layer and ethyl cellulose aqueous dispersion as outer coating controlled release layer to prepare zaleplon pulse-releasing pellets. The prescription factors and media pH The effect of drug release was optimized using the Box-Behnken effect surface design method. Results The thickness of swelling layer, composition and weight gain of controlled release coating had significant effects on the time delay and release rate of pellets. Conclusion The pellets prepared by the optimal prescription obtained by the Box-Behnken effect surface design method have good delayed-release properties.