复方丙酸氯倍他索纳米乳的制备及安全性评价

【目的】制备一种外用的水包油（O/W）型复方丙酸氯倍他索纳米乳，用于治疗宠物由真菌和螨虫混合感染引起的皮肤病。【方法】以丙酸氯倍他索（Clobetasol propionate，CP）、特比萘酚（Terbinafine）、双甲脒（Amitraz）为主要成分，并从5种常用的油性物质和3种表面活性剂中筛选出适宜的油相和表面活性剂，利用伪三元相图法筛选出纳米乳的最佳配方；通过透射电子显微镜和粒度分析仪观察其粒径大小和分布，通过加速离心试验、光稳定性和温度稳定性试验考察其品质，通过皮肤急性毒性、刺激性和致敏性试验考察其安全性。【结果】复方丙酸氯倍他索纳米乳的适宜配方（质量分数）为23%聚氧乙烯40氢化蓖麻油、15.4%乙酸乙酯、1%特比萘酚、0.05%双甲脒、0.05%丙酸氯倍他索和60.5%蒸馏水。其乳滴平均粒径为13.7 nm，分布均匀，品质稳定，无毒无刺激性。【结论】复方丙酸氯倍他索纳米乳是一种品质稳定、使用安全的治疗宠物皮肤病的外用药物。

Preparation and safety evaluation of compound Clobetasol propionate nanoemulsion

【Objective】This study prepared a external oil-water(O/W) type of compound Clobetasol propionate(CP) nanoemulsion which consist of Clobetasol propionate,Terbinafine and Amitraz.【Method】Pseudo-ternary phase diagram was used to determine the best formula.Stability test was used to evaluate its stability.Particle size and distribution were measured by particle size analyzer and transmission electron microscopy,toxicity test was used to evaluate its safety.【Result】Compound Clobetasol propionate(CP) nanoemulsion consists of 23% RH-40,15.4% ethyl acetate,1% Terbinafine,0.05% Amitraz,0.05% Clobetasol propionate,60.5% distilled water.It has stable quality,the average particle size is 13.7 nm,emulsion droplets distribute uniform,non-toxic and non-stimulation.【Conclusion】Compound Clobetasol propionate(CP) nanoemulsion is an external drug with stable quality and safety in use.