目的 制备三黄地榆油微乳凝胶剂，并评价其对大鼠深Ⅱ度烫伤创面愈合作用的治疗效果。方法 通过评估三黄地榆油在油相、乳化剂和助乳化剂中的溶解性能及相容性，确定了三黄地榆油自乳化释药系统的处方组成，并采用伪三元相图法获得其处方用量；在透射电镜下观察了三黄地榆油微乳的微观结构，通过马尔文激光粒度仪测定了微乳的粒径分布及Zeta电位；并以卡波姆940作为凝胶基质将三黄地榆油微乳制备成凝胶剂；建立大鼠深Ⅱ度烫伤模型，比较空白微乳凝胶、三黄地榆油微乳凝胶（1 g，含三黄地榆油13 mg）、三黄地榆油（13 mg）和京万红烫伤药膏（1 g）对大鼠创面的愈合效果。结果 通过评估各辅料对三黄地榆油的溶解能力及相容性，分别选择油酸乙酯、聚山梨酯80和异丙醇作为三黄地榆油自乳化释药系统的油相、乳化剂和助乳化剂，处方比例为7∶2∶1；三黄地榆油自乳化释药系统加水搅拌后即可形成淡黄色透明状微乳液，在透射电镜下可观察到微乳呈规则圆球状，分散性良好，平均粒径为（48.5±4.9） nm，PDI为（0.106±0.006），Zeta电位为（-21.3±0.9） mV。药效学研究结果显示，与模型组和空白微乳凝胶组比较，三黄地榆油、京万红烫伤药膏、三黄地榆油微乳凝胶组大鼠创面愈合率均显著增加（P<0.05），脱痂时间、愈合时间均显著减少（P<0.05），病理学改变显著改善；与三黄地榆油、京万红烫伤药膏组比较，三黄地榆油微乳凝胶组大鼠创面愈合率显著增加，脱痂时间、愈合时间均显著减少（P<0.05）。结论 成功制备三黄地榆油微乳凝胶，其具有促进烫伤创面愈合的作用。

Objective To prepare Sanhuang Diyu oil microemulsion gels and evaluate its effect on deep second-degree scald wound healing in rats.Methods By evaluating the solubility and compatibility of Sanhuang Diyu oil in the oil phase, emulsifiers and coemulsifiers, the formulation composition of Sanhuang Diyu oil self-emulsifying drug delivery systems was determined and its formulation was obtained by the pseudo-ternary phase diagram method. The microemulsion of Sanhuang Diyu oil microemulsion was observed under a transmission electron microscope, and the particle size distribution and Zeta potential of the microemulsion were measured by Malvern laser particle size analyzer. The Carbomer 940 was used as a gel matrix to prepare Sanhuang Diyu oil microemulsion gels. A rat model of deep second degree scald was established. The wound healing effect of blank microemulsion gel, three yellow and ground oil microemulsion gel (1 g, 13 mg of Sanhuang oil), SanhuangDiyu oil (13 mg) and Beijing Wan Hong scald ointment (1 g) were compared. Results By evaluating the solubility and compatibility of various excipients for Sanhuang Diyu oil, Ethyl Oleate, Tween 80 and Isopropanol were selected as the oil phase, emulsifier and co-emulsifier of Sanhuang Diyu oil self-emulsifying drug delivery systems, and the formulation ratio was 7:2:1. Sanhuang Diyu oil self-emulsifying drug delivery systems could form a light yellow transparent microemulsion after adding water and stirring. Under the transmission electron microscope, the microemulsion was spherical with uniform particle size. The average particle size was (48.5±4.9) nm, and the Zeta potential was (-21.3±0.9) mV. The pharmacodynamic studies show that, compared with model group and blank microemulsion group, wound healing rate of SanhuangDiyu oil, Beijing Wan Hong scald ointment and Sanhuang oil microemulsion gel group were significantly increased (P < 0.05), the time of callus removal and healing time were significantly reduced (P < 0.05), and pathological changes were significantly improved. Compared with SanhuangDiyu oil and Beijing Wan Hong scald ointment group, the healing rate of Sanhuang oil microemulsion gel group increased significantly, the time of callus removal and healing time were significantly reduced (P < 0.05). Conclusion Sanhuang Diyu oil microemulsion gels had the effect of promoting the healing of scald wounds, and it was worthy of further development and research.

R283.6

陕西省科技厅项目（2019SF-310）；陕西省教育厅项目（18JK1211）