中药挥发油微乳与伪三元相图的研究

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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 screen the optimal formulation of O / W microemulsion to form the essential oil of traditional Chinese medicine. Methods: The prescription of blank microemulsion was screened by pseudo-ternary phase diagram with the area of ​​microemulsion as an index. The pseudo-ternary phase diagram was used to investigate the temperature and surface The ratio of active agent to cosurfactant, ie, Km, was used to determine the effect of Km on the formation of microemulsion with volatile oil. Based on the above results, the optimal prescription of microemulsion containing volatile oil was determined by drug loading, particle size and distribution. Results: The area of ​​microemulsion formed by isopropyl myristate, polyoxyethylene hydrogenated castor oil, absolute ethanol and water was the largest in blank microemulsion prescription. The order of microemulsion microemulsion area size was as follows: Km = 4: 1> Km = 2: 1> Km = 1: 1, and the temperature has little effect on the area of ​​microemulsion containing volatile oil. The best prescription of the microemulsion containing volatile oil is: volatile oil 2.852%, isopropyl myristate 6.65%, polyoxyethylene hydrogenated castor oil 30.42%, anhydrous ethanol 7.605%, water 52.47%. CONCLUSION: The prescription of pseudo-ternary phase diagram to study the formation of microemulsion of the volatile oil of traditional Chinese medicine is scientific, convenient and reliable. The solubility of the hardly soluble volatile oil is increased by the O / W microemulsion and the stability of the preparation is improved.
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