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目的:制备硝酸益康唑(ECZ)纳米乳并对其性质进行考察。方法:在制备三元相图的基础上,优选硝酸益康唑纳米乳的最佳处方及制备工艺,并通过形态观察、ξ电位的测定、稳定性的考察等研究了硝酸益康唑的性质。结果:硝酸益康唑纳米乳的最佳处方工艺组合为聚氧乙烯40氢化蓖麻油(PEG-40氢化蓖麻油)/辛酸/癸酸三甘酯(M-812)/水,ξ电位为1.968 mV,平均粒径为64.06 nm。稳定性考察表明纳米乳在强光及高温加速试验中均较稳定。结论:硝酸益康唑纳米乳增加了益康唑的溶解度,而且剂型稳定,HPLC法检测方便。
Objective: To prepare econazole nitrate (ECZ) nanoemulsion and investigate its properties. Methods: Based on the preparation of ternary phase diagram, the optimal formulation and preparation of econazole nitrate nanoemulsion were optimized. The properties of econazole nitrate were studied by morphological observation, determination of zeta potential and stability. . Results: The optimal formulation of econazole nitrate nanoemulsion was polyoxyethylene 40 hydrogenated castor oil (PEG-40 hydrogenated castor oil) / caprylic / capric triglyceride (M-812) / water with zeta potential of 1.968 mV, the average particle size of 64.06 nm. Stability study showed that nanoemulsion in the light and high temperature accelerated tests are more stable. Conclusion: Econazole nitrate nanoemulsion increased the solubility of econazole, and the dosage form was stable.