环吡酮胺纳米乳的制备及含量测定

Preparation and content measurement of ciclopirox olamine nanoemulsion

【目的】对环吡酮胺纳米乳的配方及制备方法进行研究,并对其理化性质、稳定性、含量进行考察。【方法】利用伪三元相图优选配方,制备环吡酮胺纳米乳,通过透射电子显微镜、激光粒度测定仪、UV分光光度计对其形态、粒径和含量进行考察,通过高速离心试验和留样观察试验对其稳定性进行考察。【结果】以乙酸异丙酯为油相,聚氧乙烯氢化蓖麻油为表面活性剂,乙醇为助表面活性剂,在表面活性剂与助表面活性剂的质量比Km=3∶2时,室温下可形成稳定的水包油型纳米乳体系;乳滴呈球形,分布均匀,平均粒径为11.4nm,多分散系数(PDI)为0.132。稳定性试验显示,环吡酮胺纳米乳经10 000r/min离心20min及在-4,25,60℃贮藏6个月后,纳米乳液仍澄清均一,未出现分层、破乳现象。含量测定显示,在306.2nm处测定纳米乳液中环吡酮胺含量的专属性良好。【结论】获得制备环吡酮胺纳米乳的配方,且该配方制备工艺简单可行,制得的环吡酮胺纳米乳稳定性高。

【Ojective】 This study aimed to prepare the ciclopirox olamine nanoemulsion and evaluate its physical and chemical properties,stability and content.【Method】 After pre-experiment,the formulation including oil,surfactant and cosurfactant,was further optimized by studying the pseudo-ternary phase diagram.Then the morphology and size of ciclopirox olamine nanoemulsion were measured by Transmission Electron Microscopy（TEM） and Laser Particle Size Analyzer.Its content was measured by UV spectrophotometer.In addition,its stability was evaluated by high-speed centrifugation test（10 000 r/min,20 min） and observational test.【Result】 Stable ciclopirox olamine nanoemulsion was obtained at room temperature with the oil of isopropyl acetate,the surfactant of Cremorphor RH40,and the cosurfactant of ethanol.Mass ratio（Km） of surfactant to cosurfactant was 3∶2.Nanoemulsion droplets were spherical with a mean diameter of 11.4 nm and a polydispersity index（PDI） of 0.132.Droplets with small sizes usually possessed very high stability against sedimentation and creaming.The stability test showed that it was transparent,uniform and not stratified after centrifugation at speed of 10 000 r/min,20 min and sealed storage at tempreture-4,25,60 ℃ for six month.Content test displayed that it was specific for measurement of ciclopirox olamine in nanoemulsion at 306.2 nm by UV spectrophotometer.【Conclusion】 The preparation process is simple and feasible.Moreover,the ciclopirox olamine nanoemulsion is of high stability.Nanocarrier systems possess multiple desirable attributes.The ciclopirox olamine nanoemulsion is a new kind of self-nanoemulsion drug delivery system and it can be used to provide a new formulation for future ciclopirox olamine clinical application.