中文摘要：

目的借助星点设计-效应面法确定葫芦素口服脂质纳米乳剂的最优处方。方法提出了2个量化乳剂稳定性的常数：灭菌稳定性常数KS和冻融稳定性常数KF。用微射流仪制备葫芦素口服脂质纳米乳剂,采用星点设计-效应面法,以葫芦素口服脂质纳米乳剂的平均粒径（Y1）、灭菌稳定性常数KS（Y2）及冻融稳定性常数KF（Y3）为评价指标,考察了葫芦素口服脂质纳米乳剂处方中聚氧乙烯40氢化蓖麻油的用量（X1）、大豆卵磷脂的用量（X2）及中链脂肪酸甘油三酯的用量（X3）对制剂的影响,以效应面法预测最佳处方。结果优选的最优处方为：m（聚氧乙烯40氢化蓖麻油）∶m（大豆卵磷脂）∶m（中链脂肪酸甘油三酯）=1.15∶0.50∶5.52。采用优化处方制得的葫芦素口服脂质纳米乳剂的平均粒径为（113.6±2.1）nm,灭菌稳定性常数KS为2.92±0.7,冻融稳定性常数KF为5.14±0.2,同预测值的偏差均较低,最大偏差为4.6%。结论星点设计-效应面法所建立的模型能较好地应用于葫芦素口服脂质纳米乳剂处方的优化。

英文摘要：

Objective To optimize the preparation of Cucurbitacin oral-lipid-nanoemulsion using response surface methodology（RSM）.Methods The stability of nanoemulsion was quantitated by KS and KF.The Cucurbitacin oral-lipid-nanoemulsion was prepared by microfluidics.In the central composite design-response surface methodology（RSM-CCD）,mean diameter,sterilizing stability and freeze-thaw stability were selected as response variables,RH40%（X1,w/%）,SPC%（X2,w/%）,MCT%（X3,w/%）were employed as independent variables.The optimal formulation was predicted by response surface methodology.Results The optimal formulation of Cucurbitacin oral-lipid-nanoemulsion could be obtained at 1.15% of RH40,0.5% of SPC and 5.52% of MCT.The mean diameter,sterilizing stability and freeze-thaw stability of the optimal preparation were（113.60±2.10）nm,（2.92±0.70） and（5.14±0.20）,respectively.The deviations between measured values and predicted values were not considerable（the maximum deviation was 4.6%）.Conclusions The model established by the RSM-CCD method could be used for optimization of the preparation of cucurbitacin oral-lipid-nanoemulsion.