马齿苋纳米乳喷雾的制备及其皮肤刺激性过敏性反应研究

Research on Production,Skin Irritation and Allergic Reactions of Purslane Nano Emulsion Spray

目的:制备马齿苋纳米乳喷雾并考察其皮肤刺激性和过敏性。方法:筛选油相、表面活性剂及助表面活性剂,并采用水滴定法绘制伪三元相图,根据各系统的纳米乳乳区大小确定最佳处方,制备马齿苋纳米乳喷雾并考察其粒径、Zata电位及稳定性。另外,采用普通级新西兰兔进行皮肤刺激性试验,普通级花色豚鼠进行皮肤过敏性试验。结果:制备出具有良好稳定性的马齿苋纳米乳喷雾。且新西兰兔完整皮肤及破损皮肤单次给药1、24、48、72 h后,均未见刺激性;对豚鼠皮肤单次给药后以及用药后第7、14天再次给药后,致敏发生率均为0%。结论:所制备的马齿苋纳米乳喷雾其粒径符合要求且稳定性良好,同时该喷雾对新西兰兔皮肤无刺激反应,对豚鼠皮肤亦无致敏反应,局部皮肤给药相对安全。

Objective： To product the Purslane nano emulsion spray and to determine the skin irritation and allergic reactions of Purslane nano emulsion spray. Methods： To screen surfactant,cosurfactant and oil phase and prepare the Purslane nano emulsion spray by using pseudo- ternary diagram method. The skin irritation experiment was conducted on rabbits and the skin allergic reaction experiment was carried out on guinea pig. Results： 1,24,48,72 h after single- dose,skin irritation on integral and damaged skin of rabbits was undetected. After single- dose and the second single- dose on the 7thand 14 thday,no skin allergic reaction on the skin of guinea pig was found. Conclusion： The prepared Purslane nano emulsion spray is stable. No skin irritation on integral and damaged skin of rabbits was observed while skin allergic reaction on the skin of guinea pig was unfound.