苯扎贝特纳米结构脂质载体的制备及质量评价.pdf

苯扎贝特纳米结构脂质载体的制备及质量评价 ? 金银秀，王玉新，石雷，潘万贵，游锦晨，李姿生(台州职业技术学院化学制药研究所，浙江 台州，318000) 摘要：目的 制备苯扎贝特纳米结构脂质载体(bezafibrate nanostructured lipid carriers, BZF-NLC)，并对其进行质量评价。 方法 采用熔融-乳化法制备 BZF-NLC，正交试验筛选最优处方。使用扫描电镜观察 BZF-NLC 形态，激光粒径测定仪测 定 Zeta 电位、粒径及分布，葡聚糖柱层析法测定包封率。结果 按优化条件制备的 BZF-NLC 为类球形粒子，平均粒径 为(127.6±3.16)nm，多分散系数为 0.191±0.02，粒度分布均匀，Zeta 电位为(?28.4±0.7)mV，包封率为(94.28±1.09)%，体外 释药具有缓释特征。结论 熔融-乳化法制备的 BZF-NLC 具有较好的理化性质，有一定的缓释作用。 关键词：苯扎贝特；纳米结构脂质载体；制备；质量评价 中图分类号：R944.1 文献标志码：B 文章编号：1007-7693(2016)12-1526-03 DOI: 10.13748/ki.issn1007-7693.2016.12.009 Preparation and Quality Evaluation of Bezafibrate Nanostructured Lipid Carriers JIN Yinxiu, WANG Yuxin, SHI Lei, PAN Wangui, YOU Jinchen, LI Zisheng(Chemical Pharmaceutical Research Institute, Taizhou Vocational Technical College, Taizhou 318000, China) ABSTRACT: OBJECTIVE To prepare bezafibrate nanostructured lipid carriers(BZF-NLC) and evaluate the quality. METHODS BZF-NLC was prepared by melt-emulsification method, and the optimal prescription was screened by orthogonal experiment. The morphology of BZF-NLC was observed by scanning electron microscope. Zeta potential, particle size and distribution were determined by granulometer. The entrapment efficiency was determined by Sephadex gel column chromatography. RESULTS BZF-NLC prepared under optimum conditions was approximately spherical with average particle size of (127.6±3.16) nm, PDI of 0.191±0.02, which were distributed evenly, and zeta potential of (?28.4±0.7)mV, encapsulation efficiency of (94.28±1.09)%, respectively. The profiles of BZF-NLC in vitro release had the features of sustainedrelease. CONCLUSION It shows that there are good physicochemical properties of BZF-NLC prepared by melt-emulsification method, and had a certain degree of