目的 制備三黃地榆油微乳凝膠劑，并評(píng)價(jià)其對(duì)大鼠深Ⅱ度燙傷創(chuàng)面愈合作用的治療效果。方法 通過評(píng)估三黃地榆油在油相、乳化劑和助乳化劑中的溶解性能及相容性，確定了三黃地榆油自乳化釋藥系統(tǒng)的處方組成，并采用偽三元相圖法獲得其處方用量；在透射電鏡下觀察了三黃地榆油微乳的微觀結(jié)構(gòu)，通過馬爾文激光粒度儀測(cè)定了微乳的粒徑分布及Zeta電位；并以卡波姆940作為凝膠基質(zhì)將三黃地榆油微乳制備成凝膠劑；建立大鼠深Ⅱ度燙傷模型，比較空白微乳凝膠、三黃地榆油微乳凝膠（1 g，含三黃地榆油13 mg）、三黃地榆油（13 mg）和京萬紅燙傷藥膏（1 g）對(duì)大鼠創(chuàng)面的愈合效果。結(jié)果 通過評(píng)估各輔料對(duì)三黃地榆油的溶解能力及相容性，分別選擇油酸乙酯、聚山梨酯80和異丙醇作為三黃地榆油自乳化釋藥系統(tǒng)的油相、乳化劑和助乳化劑，處方比例為7∶2∶1；三黃地榆油自乳化釋藥系統(tǒng)加水?dāng)嚢韬蠹纯尚纬傻S色透明狀微乳液，在透射電鏡下可觀察到微乳呈規(guī)則圓球狀，分散性良好，平均粒徑為（48.5±4.9） nm，PDI為（0.106±0.006），Zeta電位為（-21.3±0.9） mV。藥效學(xué)研究結(jié)果顯示，與模型組和空白微乳凝膠組比較，三黃地榆油、京萬紅燙傷藥膏、三黃地榆油微乳凝膠組大鼠創(chuàng)面愈合率均顯著增加（P<0.05），脫痂時(shí)間、愈合時(shí)間均顯著減少（P<0.05），病理學(xué)改變顯著改善；與三黃地榆油、京萬紅燙傷藥膏組比較，三黃地榆油微乳凝膠組大鼠創(chuàng)面愈合率顯著增加，脫痂時(shí)間、愈合時(shí)間均顯著減少（P<0.05）。結(jié)論 成功制備三黃地榆油微乳凝膠，其具有促進(jìn)燙傷創(chuàng)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

陜西省科技廳項(xiàng)目（2019SF-310）；陜西省教育廳項(xiàng)目（18JK1211）