天然冰片微乳凝胶的制备及其质量评价

Preparation and Quality Evaluation of Natural Borneol Microemulsion Gel

目的:研究天然冰片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天然冰片微乳凝胶,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:所得天然冰片微乳凝胶处方:天然冰片2.2%、聚氧乙烯蓖麻油(EL) 9.1%、 1, 2-丙二醇1.8%、蓖麻油3.6%、卡波姆0.6%、甘油3.8%、加水至50 g;天然冰片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(45.28±7.95) nm, pH值5.43±0.02,保湿率(93.55±0.29)%,黏度(41883±5) mPa·s,含天然冰片(20.34±0.21) mg/g;耐热耐寒试验表明天然冰片微乳凝胶应低温贮存。结论:天然冰片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 natural borneol microemulsion gel. The quality and the stability were evaluated.MethodsThe prescription and preparation technology were selected and optimized through the compatibility test and thepseudo-ternary phase diagram. natural borneol microemulsion gel was prepared by adding gelation. The appearance,pH value, viscosity, moisturerate, and the drug concentration were evaluated.ResultsThe prescription composition of natural borneol microemulsion gel was natural borneol(2. 2%), CremophorEL(9. 1%), 1, 2-propanediol(1. 8%), castoroil(3. 6%), carbopol-940(0. 6%), glycerol(2%), with ultrapure water adding to 50 g. The optimum formulation exhibited clear and transparent, uniform exquisite, moderate viscosity, and well spreadable, with the particle diameter of(45. 28 ± 7. 95) nm, pHvalueof(5. 43± 0. 02), moisture rate of(93. 55 ± 0. 29)%, The result of heat and cold resistance test showed that the preparation was needed to be stored at low-temperature.ConclusionThe preparation of CVO microemulsion gel is simple, corresponding to the main index of topical gel preparation and offering the basis for further research and development.