中药挥发油微乳与伪三元相图的研究

Study on Chinese Herbs′ Volatile Oil Micro-emulsions by Means of Pseudo-ternary Phase Diagram

目的:筛选中药挥发油形成O/W微乳的最佳处方。方法:以微乳区域面积为指标,采用伪三元相图筛选空白微乳的处方;以微乳区域面积为指标,在获得的空白微乳处方基础上采用伪三元相图考察温度、表面活性剂与助表面活性质量之比即Km值对含挥发油微乳形成的影响;综合以上实验结果,以载药量、粒径大小及分布确定含挥发油微乳的最佳处方。结果:空白微乳处方中肉豆蔻酸异丙酯、聚氧乙烯氢化蓖麻油、无水乙醇与水形成的微乳区域面积最大,含挥发油微乳形成的微乳区域面积大小顺序为:Km=4∶1>Km=2∶1>Km=1∶1,温度对含挥发油微乳区域面积的影响不大。含挥发油微乳的最佳处方是:挥发油2.852%、肉豆蔻酸异丙酯6.65%、聚氧乙烯氢化蓖麻油30.42%、无水乙醇7.605%、水52.47%。结论:采用伪三元相图研究中药复方挥发油形成微乳的处方,方法科学、便捷、可靠,通过制成O/W微乳增加了难溶性挥发油类药物的溶解度,提高该制剂的稳定性。

Objective： To optimize the formulation of Chinese herbs′ volatile oil micro emulsion.Methods： Sreened the formulation of blank micro-emulsion and the formulation of micro-emulsion contained volatile oil by means of pseudo-ternary phase diagram.Results： System of isopropyl myristate,polyoxyethylene hydrogenated castor oil,absolute ethyl alcohol and water could formed the largest area of micro-emulsion.The optimal formulation of micro-emulsion contained volatile oil was：volatile oil consisted of 2.852%,isopropyl myristate 6.65%,polyoxyethylene hydrogenated castor oil 30.42%,absolute ethyl alcohol 7.605% and water 52.47%.Conclusions： Using pseudo-ternary phase diagram to optimize the formulation of Chinese herbs′micro-emulsion is scientific and feasible.The volatile oil′s solubility is also increased by made of oil-in-water type micro-emulsion and insured the stability.