运用Box—Behnken设计-效应面法对尼莫地平纳米乳剂处方工艺的优化

目的：运用Box—Behnken设计-效应面法优化尼莫地平纳米乳剂的处方工艺。方法：采用微射流法制备尼莫地平纳米乳剂，分别以聚氧乙烯蓖麻油（CremophorEL）的用量（X1）、大豆卵磷脂（SPC）的用量（X2）和中链脂肪酸甘油三酯（MCT）的用量（X3）为考察对象，以平均粒径（MD）（Y1）、粒径分布（CV）（Y2）为评价指标，运用三因素三水平Box．Behnken设计．效应面法筛选尼莫地平纳米乳剂的最佳处方工艺。结果：尼莫地平纳米乳剂的最优处方用量为X1=3．68％，X2=2．96％，X3=8．6％；按此处方用量制得的尼莫地平纳米乳剂，其平均粒径为（63．3±3．4）nm，粒径分布为（O．26±0．03）％。结论：运用Box—Behnken设计-效应面法优化尼莫地平纳米乳剂的处方工艺是可行的。

Optimization of Preparation Process of Nimodipine Nano-emulsion by Using Box-Behnken Design-Response Surface Method

Objective： To optimizate the preparation process of nimodipine nano-emulsion by using the Box - Behnken design-response surface method. Methods： By using micro jet method the nano-emulsion was preparated, us- ing polyethylene glycol castor oil（Cremopbor EL）（X1）, soybean lecithin（SPC）（X2） and the chain fatty acid triglyceride （MCT）（X3 as the examination object, with the average particle size（MD）（Y1） and particle size distribution（CV）（Y2） as evaluation indexes. Screen the preparation process of nimodipine nano-emulsion by using 3 factors 3 levels Box-Behnk- en design-response surface method. Results： The optimal dosage of formulation of nimodipine nano-emulsion is X1= 3.68%, X2=2.96%, X3=8.6%; according to the prescribed dosage of nimo nano-emulsion the average particle sizes was （63.3±3.4） nm and the particle size distribution was （0.26±0.03）%. Conclusion： it is feasible to optimize the prepara- tion process of nimodipine nano-emulsion by using the Box-Behnken design response surface method.