目的 研究茶树油微乳凝胶的处方与制备工艺, 并对其质量与稳定性进行评价。方法 通过配伍试验与伪三元相图筛选并优化微乳处方与工艺, 采用凝胶加入法制备茶树油微乳凝胶, 并对其外观性状、pH值、黏度、保湿率与药物浓度进行评价。结果 所得茶树油微乳凝胶处方:茶树油0.6%、聚氧乙烯氢化蓖麻油1.2%、聚乙二醇400 0.2%、卡波姆- 980 0.2%、甘油2%, 加蒸馏水至50 g;茶树油微乳凝胶外观澄清透明、均匀细腻、黏稠度适中、涂展性良好;平均粒径(38.38±2.30)nm, Zeta电位(-56.00±5.82)mV, pH值5.52±0.01, 黏度(48 834±5.13)Pa·s, 保湿率(96.74±0.52)%, 含茶树油(5.79±0.03)mg/g;耐热耐寒试验表明茶树油微乳凝胶应低温贮存。结论 茶树油微乳凝胶制备工艺简单, 符合凝胶局部外用制剂主要指标要求, 为进一步研究与开发提供依据。

Objective To study the prescription and preparation technology of tea tree oil (TTO) microemulsion gel. The quality and the stability were evaluated. Methods The prescription and preparation technology were selected and optimized through the compatibility test and the pseudo-ternary phase diagram. TTO microemulsion gel was prepared by adding gelatin. The appearance, pH value, viscosity, moisture rate, and the drug concentration were evaluated. Results The prescription composition of TTO microemulsion gel was TTO (0.6%), Cremophor RH-40 (1.2%), PEG 400 (0.2%), carbopol-980 (0.2%), glycerol (2%), with distilled water adding to 50 g. The optimum formulation exhibited clear and transparent, uniform exquisite, moderate viscosity, and well spreadable, with the particle diameter of (38.38 ± 2.30) nm, zeta potential of (-56.00 ± 5.82) mV, pH value of 5.52 ± 0.01, viscosity of (48 834 ± 5.13) Pa·s, moisture rate of (96.74 ± 0.52)%, and the drug-loaded of (5.79 ± 0.03) mg/g. The result of heat and cold resistance test showed that the preparation was needed to be stored at low-temperature. Conclusion The preparation of TTO microemulsion gel is simple, corresponding to the main index of gelata for topical drug delivery preparation and offering the basis for further research and development.

国家自然科学基金资助项目(30973953C1909);广东省科技计划项目(粤科规划字[2013]137号)