Box-Behnken法优化渗透泵微丸丸芯的制备工艺

Optimization of the preparation process of osmotic pump pellet core by Box-Behnken method

目的:优化渗透泵微丸丸芯的处方、制备工艺,为渗透泵载药微丸研究提供优质丸芯。方法:在单因素的基础上,以休止角、硬度为评价指标,采用Box-Behnken法优选渗透丸芯的最佳制备工艺。结果:由单因素试验及Box-Behnken试验可知,以乳糖-微晶纤维素-PVP(5∶1∶0.1,w/w)为丸芯组成,以挤出转速30r·min^(-1),挤出温度24℃,滚圆转速1 800r·min^(-1)为最佳制备工艺,制得粒径为0.8mm,休止角为28.42°,硬度为17.52kg·cm-2的丸芯。结论:本实验筛选出渗透泵丸芯的处方组成及制备工艺,可为以渗透压为动力的渗透泵丸芯的制备研究提供参考。

OBJECTIVE To optimize the formula of osmotic pump pellets and preparation process for osmotic pump drugloaded pellets.METHODS On the basis of a single factor,with the angle of repose and hardness as evaluation indexes,the preparation process of osmotic pump pellets was optimized by Box-Behnken method.RESULTS Single factor test and Box-Behnken test showed that the pellet core with a particle size of 0.8 mm,a resting angle of 28.42 degree and a hardness of 17.52 kg·cm2 was prepared to produce pellets composed of lactose and microcrystalline cellulose-PVP（5∶1∶0.1,w/w）,under the following optimum conditions：extrusion speed 30 r·min-1,the extrusion temperature 24 ℃,the speed of spheronization 1 800 r·min-1.CONCLUSION The formula and preparation process of osmotic pump pellets are screened out in this experiment,which can be used as a reference for the preparation of osmotic pump pellets with osmotic pressure as power for drug release.