目的 研究茶树油凝胶的处方和制备工艺，并对其抗炎、抑菌功效与刺激性进行评价。方法 以卡波姆-940为凝胶基质，聚氧乙烯40氢化蓖麻油（Cremophor RH-40）与1,2-丙二醇为溶剂制备茶树油凝胶，并考察其外观性状、pH值、黏度、保湿率、药物含量与稳定性；分别对茶树油凝胶的抗炎、抑菌效果与刺激性进行评价。结果 筛选得茶树油凝胶处方：茶树油1.0%、Cremophor RH-40 5.0%、1,2-丙二醇5.0%、卡波姆-940 0.6%、甘油8.0%，加蒸馏水至100 g，三乙醇胺溶液调pH值至5.0；获得澄清透明、均匀细腻、黏稠度适中，且涂展性良好的茶树油凝胶；pH值5.52±0.03，黏度（48 782±25）mPa·s，放置24 h后保湿率（93.32±0.38）%，含茶树油（9.55±0.10）mg/g；茶树油凝胶对小鼠耳廓肿胀抑制率为46.15%，且与阴性对照组相比差异显著（P<0.01）；对金黄色葡萄球菌、大肠杆菌与绿脓杆菌的抑菌圈直径分别为（15.50±0.96）、（15.25±2.36）、（15.75±1.91）mm；茶树油凝胶的半数溶血率（LC₅₀）为456 157 mg/L，血红蛋白变性指数（DI）为157.98%，LC₅₀/DI值为2 887.44，表明无眼刺激性；一次给药后茶树油凝胶对家兔皮肤的刺激反应平均积分为0.125，连续给药14 d后动物刺激反应平均积分为0.036，表明对家兔皮肤无刺激性反应；高速离心、强光照与耐寒耐热实验结果表明制剂稳定性良好，应置于阴凉避光处贮存。结论 茶树油凝胶处方设计合理，制备工艺简单，符合凝胶局部外用制剂主要指标要求，具有一定抗炎、抑菌功效，安全性良好，为茶树油进一步研究与开发奠定基础。

Objective To study the prescription and preparation technology of tea tree oil gel, and evaluate its anti-inflammatory efficacy, antibacterial effect and the irritation. Methods The tea tree oil gel was prepared using the carbomer-940 as gel matrix, Cremophor RH-40 and 1,2-propylene glycol as solvents. The appearance characters, pH value, viscosity, moisture retention, drug content, and the stability were observed. The anti-inflammatory efficacy, the antibacterial effect and the irritation of tea tree oil gel were evaluated. Results The prescription of tea tree oil gel was selected as following tea tree oil (1.0%), Cremophor RH-40 (5.0%), 1,2-propylene glycol (5.0%), Carbomer-940 (0.6%), glycerol (8.0%), with distilled water 100 g, adjusting pH to 5.0 by triethanolamine. The gel exhibited transparent, well uniformity, appropriate viscosity and fine coating expansion performance, with pH value of 5.52 ±0.03, viscosity at (48 782 ±25) mPa·s, the moisture retaining rate of (93.32 ±0.38)% for 24 h test, containing tea tree oil of (9.55 ±0.10) mg/g. The inhibition rate of tea tree oil gel on the mouse auricle swelling was 46.15%, which was significantly different as compared to the negative control group (P < 0.01). The diameters of inhibition zone of the gel against Staphylococcus aureus, Escherichia coli, and Pseudomonas aeruginosa respectively was (15.50 ±0.96), (15.25 ±2.36), and (15.75 ±1.91) mm. The half hemolysis rate (LC₅₀) and the hemoglobin degeneration index (DI) respectively were 456 157 mg/L and 157.98%. The tea tree oil gel had no eye irritation in rabbits based on the value of LC₅₀/DI 2 887.44. Fourteen consecutive'days administration indicated that the tea tree oil gel had no skin irritation in rabbits. The illumination score of irritative reaction to the rabbit skin was 0.125 after a single administration, while that was 0.036 after successive administration experiment. The results of high speed centrifugalization cold- resistance and heat-resistance tests showed that the preparation exhibited good stability, which needed to be kept tightly in a cool place and protected from light. Conclusion The formulation design was reasonable, while the preparation technology was simple, corresponding to the main index of the gel for topical application, with good anti-inflammatory efficacy, antibacterial effect and safety, which offered the basis for further research and development of tea tree oil.

2017年度国家级大学生创新创业训练计划立项项目（201710573013）；广东省化妆品工程技术研究中心开放基金资助项目（粤科函产学研字[2015]1487号）