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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、p H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)m V,p H值5.52±0.01,黏度(48 834±5)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 preparation and preparation of tea tree oil microemulsion gel and to evaluate its quality and stability. Methods The formulation and technology of microemulsion were screened and optimized by compatibility experiment and pseudo-ternary phase diagram. The microemulsion gel of tea tree oil was prepared by gel addition method. The appearance, pH value, viscosity, moisture retention and drug concentration Evaluation. Results The obtained tea tree oil microemulsion gel prescription: tea tree oil 0.6%, polyoxyethylene hydrogenated castor oil 1.2%, polyethylene glycol 400 0.2%, carbomer -980 0.2%, glycerol 2%, add distilled water to 50 g; The average particle size (38.38 ± 2.30) nm, Zeta potential (-56.00 ± 5.82) m V and p H value were 5.52 ± 0.01, Viscosity (48 834 ± 5) Pa · s, moisture retention rate (96.74 ± 0.52)%, containing tea tree oil (5.79 ± 0.03) mg / g; heat-resistant and cold-tolerant tests showed that tea tree oil microemulsion should be stored at low temperature. Conclusion Tea tree oil microemulsion gel preparation process is simple, in line with the gel topical formulations of the main indicators of the request for further research and development to provide the basis.