复方特比萘芬纳米乳的制备及其含量测定

【目的】研制复方特比萘芬纳米乳，并对其含量进行测定。【方法】以特比萘芬、丁香酚和红霉素为供试药物，通过绘制伪三元相图筛选复方特比萘芬纳米乳处方，利用透射电子显微镜(TEM)、Nicomp 388/Zeta PALS激光粒度测定仪分别考察其形态和粒径，采用染色法鉴别纳米乳的类型，利用高效液相色谱法对其含量测定方法进行研究。【结果】复方特比萘芬纳米乳最佳配方中各组分的质量分数分别为：特比萘芬1.3%，丁香酚2.5%，红霉素1.3%，吐温-80 24%，无水乙醇12%，肉豆蔻酸异丙酯2%，蒸馏水56.9%。透射电镜下，复方特比萘芬纳米乳呈圆球形，无粘连；其平均粒径(Z-Average)为11.9 nm，多分散系数(PDI)为0.06。另外还建立了精确测定复方特比萘芬纳米乳3种主药含量的高效液相色谱法。【结论】复方特比萘芬纳米乳制备工艺简单，稳定性良好且质量可控，有望应用于宠物临床。

Preparation and content determination of compound terbinafine nanoemulsion

【Objective】The compound terbinafine nanoemulsion was prepared and its contents were determined.【Method】Taking terbinafine,eugenol,and erythromycin as tested medicines,the preparation of compound terbinafine nanoemulsion was optimized by studying the pseudoternary phase diagrams.Its shape and particle size distribution were detected by TEM and Nicomp 388/Zeta PALS Particle Sizing System and its type was identified by staining,the method of its determination was studied by HPLC.【Result】The optimum preparation was w(terbinafine)=1.3%,w(eugenol)=2.5 %,w(erythromycin)=1.3%,w(Tween-80)=24%,w(ethanol)=12%,w(isopropyl myristate)=2%,w(distilled water)=56.9%.The compound terbinafine nanoemulsion was spherical and no adhesion,with a mean diameter of 11.9 nm and the polydispersity index(PDI) 0.06.The method of the three main component determination by HPLC was established.【Conclusion】The preparation procedure of compound terbinafine nanoemulsion is simple and the quality is under control.It is expected to be applicable to the veterinarian clinic.