Box-Behnken设计-效应面法优化番泻苷微丸的制备工艺  

Optimization of the preparation process of anthraglucosennin pellets using Box-Behnken surface response design

作　　者：彭淑娟[1] 王亚静[1] 张伟玲[1] 王艳明[1] 皮佳鑫[1] 孙士真[1] 田慧[1] 

机构地区：[1]天津中医药大学现代中药发现与制剂技术教育部工程研究中心,天津300193

出　　处：《中国新药杂志》2012年第16期1933-1938,共6页Chinese Journal of New Drugs

摘　　要：目的:考察挤出-滚圆的工艺参数对番泻苷微丸性质的影响,优化番泻苷微丸的制备工艺。方法:采用挤出-滚圆法制备微丸,以挤出速度、滚圆速度、滚圆时间为自变量,得丸率、圆整度、归一化总值为因变量,采用3因素3水平的Box-Behnken设计进行试验,借助Minitab 14拟合评价指标对自变量的效应面,分析工艺参数对微丸性质的影响,优化微丸制备工艺,并对优化工艺进行验证。结果:最优工艺参数:挤出速度为17 r·min-1,滚圆速度为740 r·min-1,滚圆时间为3 min。该工艺制备的微丸得丸率(84.71±2.38)%,水平面临界角(9.38±0.60)°,总分(0.90±0.04),实测值与预测值(0.86)无显著差异。结论:采用Box-Be-hnken设计-效应面法能够快速得到番泻苷微丸制备工艺的优化模型,实现了工艺的优化。Objective：To evaluate the effect of pelletization process parameters on the properties of anthra- glucosennin pellets, and to optimize the preparation process. Methods： The pellets were prepared by extrusion/ spheronization process. Using extrusion speed, spheronization speed, and spheronization time as variance while yield, degree of spherical pellets and overall score as response, experiments were carried out by Box-Behnken design of three factors at three levels. The effects of pelletization process parameters on the properties of anthraglucosennin pellets were analyzed,and the pelletization process parameters were optimized by using Minitab 14 to fit the re- sponse surface of response to variance. Results：The best process parameters were as bellowing：extrusion speed 17 r-min^-1, spheronization speed 740 r.min^-1 and spheronization time 3 rain. The pellets prepared under this condi- tion had a yield of （84.71±2.38）% and an angle of repose of （9.38 ±0.60）.. The total score predicted by e- quation was 0.86 and the observed value was （0.90 ± 0.04）. There was no apparent difference between the ob- served and predictive responses. Conclusion： The optimal model of preparation process can be quickly obtained by using Box-Behnken surface response design. The optimization has been accomplished.

关 键 词：番泻苷 微丸 BOX-BEHNKEN设计 效应面法 挤出-滚圆 

分 类 号：R943.4[医药卫生—药剂学]