论文部分内容阅读
以盐酸布替萘芬为供试药物,通过绘制伪三元相图筛选处方研制盐酸布替萘芬纳米乳,并对其质量进行了评价。结果表明:该纳米乳为水包油型纳米乳,透射电镜下乳滴呈圆球形,分布均匀无黏连。平均粒径为12.8nm,多分散系数为0.137,平均zeta电位为(-10.3±0.1)mV。建立的高效液相色谱测定方法显示,在质量浓度30～150mg/L范围内,盐酸布替萘芬与峰面积呈良好的线性关系(r2=0.999 6),平均回收率为(99.95±0.18)%,RSD为0.18%。该盐酸布替萘芬纳米乳稳定性良好,含量与粒径变化微小。有望提供一种制备工艺简单、质量可控、稳定性良好的抗真菌外用纳米药物应用于宠物临床。
Taking butenafine hydrochloride as the test drug, blebensine hydrochloride nanoemulsion was prepared by drawing prescription of pseudo-ternary phase diagram and its quality was evaluated. The results showed that the nanoemulsion was an oil-in-water nanoemulsion. The droplets of the nanoemulsion showed a spherical shape under transmission electron microscopy with uniform distribution without adhesion. The average particle size was 12.8 nm, the polydispersity was 0.137 and the average zeta potential was (-10.3 ± 0.1) mV. The established HPLC method showed that there was a good linear relationship between the concentration of butenafine hydrochloride and the peak area (r2 = 0.999 6) and the average recovery (99.95 ± 0.18) in the range of 30-150 mg / %, RSD 0.18%. The butenafine hydrochloride nanoemulsion stability is good, content and particle size changes slightly. It is expected to provide an antifungal topical nanometer drug with simple preparation process, controlled quality and good stability for pet clinical application.