| 摘要: |
| 【目的】研制伊曲康唑纳米乳并评价其质量，考察纳米乳中伊曲康唑含量。【方法】以伊曲康唑为主要活性成分，肉桂醛和乙酸乙酯为混合油相，EL-40为表面活性剂，异丙醇为助表面活性剂，通过绘制伪三元相图确定伊曲康唑纳米乳的最优配方。利用透射电子显微镜（TEM）、激光粒度分析仪等评价伊曲康唑纳米乳的质量，利用紫外分光光度计考察纳米乳中伊曲康唑含量。【结果】经筛选，伊曲康唑纳米乳配方中各物质的质量分数为：伊曲康唑1.24%，肉桂醛 4.58%，乙酸乙酯4.58%，EL-40 24.44%，异丙醇12.17%，蒸馏水52.99%。在TEM下，伊曲康唑纳米乳乳滴为圆球形，分布均一，平均粒径为14.48 nm，多分散系数（PDI）为0.014。制备出的纳米乳澄清透明、稳定性良好。测定伊曲康唑纳米乳中伊曲康唑含量的最佳波长为261 nm，检测方法的专属性良好。【结论】伊曲康唑纳米乳稳定性好且制备工艺简单，用于测定伊曲康唑纳米乳中伊曲康唑含量的紫外分光光度法专属性好、精密度高。 |
| 关键词: 伊曲康唑 纳米乳 质量评价 |
| DOI： |
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| 基金项目:陕西省重大科技创新专项（K332020916） |
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| Preparation and quantitative determination of itraconazole nanoemulsion |
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GAO Rui,OUYANG Wu-qing
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| Abstract: |
| 【Objective】This paper focused on the development,quality evaluation and content measurement of itraconazole nanoemulsion.【Method】The formulations of itraconazole nanoemulsion were sifted by taking itraconazole,cinnamaldehyde plus acetic ether,EL-40 and isopropanol as main active ingredient,oil phase mixture,surfactant and cosurfactant,respectively,and drawing the pseudoternary phase diagrams.The quality was evaluated using TEM and laser scattered particle analyzer.The content of itraconazole was measured by ultraviolet spectrophotometry.【Result】The screened optimal formula was:Itraconazole 1.24%,cinnamaldehyde 4.58%,acetic ether 4.58%,EL-40 24.44%,isopropanol 12.17%,and distilled water 52.99%.The droplets were spherical and distributed evenly under TEM,with a mean diameter of 14.48 nm and a polydispersity index (PDI) of 0.014.The nanoemulsion was clear and colorless with good stability.An ultraviolet spectrophotometry based method with optimal wavelength of 261 nm and good specificity was established to measure content of itraconazole in itraconazole nanoemulsion.【Conclusion】The preparation of itraconazole nanoemulsion was simple and the stability of obtained product was good.The established ultraviolet spectrophotometry method had good properties and high precision. |
| Key words: itraconazole nanoemulsion quality evaluation |
