葛根素磷脂复合物自乳化释药系统的处方优选

Optimization of Formulation of Self-emulsifying Drug Delivery Systems of Puerarin Phospholipid Complex

目的:优选葛根素磷脂复合物自乳化释药系统的处方工艺。方法:以乳化程度和乳滴粒径大小为指标,通过溶解度试验和相图绘制筛选处方中油相、非离子表面活性剂、助表面活性剂,确定最佳处方。结果:优选的处方工艺为油酸乙酯(油相)-聚山梨脂80(非离子表面活性剂)-无水乙醇(助表面活性剂)5∶3∶2,乳化时间40.53 s,平均粒径107.3 nm。结论:制备的葛根素磷脂复合物自乳化系统为黄色澄明液体,加水后可形成澄清透明并带淡蓝色乳光的乳液,且体系无起泡现象,乳化效果好。

Objective： To optimize formulation of self-emulsifying drug delivery systems of puerarin-soybean lecithin complex. Method： With the degree of emulsifying and particle size of emulsion droplet as indexes,oil phase,non-ionic surfactant and co-surfactant in the formulation were screened by solubility experiment and drawing phase diagram,and to determine optimum formulation. Result： Optimum formulation of the self emulsifying drug delivery system was as following：ethyloleate as oil phase,Tween-80 as nonionic surfactant and ethanol as co-surfactant,the proportion of them 5：3：2,emulsifying time 40.53 s,the average particle size 107.3 nm. Conclusion： Prepared self-emulsifying drug delivery systems of puerarin-soybean lecithin complex was yellow clear liquid,it could be a clear and transparent with light blue opalescent emulsion after adding water,and this system had good emulsifying effect without blistering.