摘要
目的:研究鼻安纳米乳凝胶的制备及含量测定方法。方法:通过绘制伪三元相图及正交设计试验法优选纳米乳处方;采用气相色谱法测定鼻安纳米乳凝胶中薄荷脑和丁香酚含量。结果:最优的鼻安纳米乳处方为油相∶RH-40∶1,2-丙二醇=5∶12∶4。以泊洛沙姆407为凝胶基质成型性较优。薄荷脑、丁香酚分离度良好,薄荷脑在0.052~0.52 mg·mL~(-1)浓度范围内与其峰面积积分线性关系良好,平均回收率为98.5%;丁香酚在0.012 8~0.128 mg·mL~(-1)浓度范围内与其峰面积积分线性关系良好,平均回收率为97.7%。结论:鼻安纳米乳凝胶处方组成合理,制备工艺简单,含量测定方法可行。
Objective:To prepare and assay the Bian nanoemulsion-based gels. Methods:Optimize the formula composition of Bian nanoemulsion by pseudo-ternary phase diagram and orthogonal test.GC method was established to determine drug content in the gel.Results:The formula composition of Bian nanoemulsion was with the mass ratio of oil phase,Cremopher RH-40 and 1,2-propanediol of 5∶12∶4. Poloxamer 407 was used as gel matrix.Menthol and eugenol were separated well.Linear relationship of menthol was good in concentration range of 0.052~0.52 mg·mL~(-1) and average recovery was 98.5%.Linear relationship of eugenol was good in concentration range of 0.012 8~0.128 mg·mL~(-1) and average recovery was 97.7%.Conclusion:The technology of preparation is easy and method of assaying is feasible.
引文
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