伊曲康唑白蛋白纳米粒混悬液的制备与体外评价.PDF

. 216 . 中国抗生素杂志2018年2月第43卷第2期 文章编号：1001-8689(2018)02-0216-07 伊曲康唑白蛋白纳米粒混悬液的制备与体外评价 1 2,* 1 付永莉 谢向阳 罗婷 (1 武汉市精神卫生中心，药剂科，武汉430012 ；2 中国人民解放军武汉总医院药剂科，武汉430012) 摘要：目的 制备伊曲康唑白蛋白纳米粒混悬液，并优化其处方和制备工艺，同时对所优化的白蛋白纳米粒混悬液进行评 价。方法 采用单因素实验法筛选超高压微射流技术制备伊曲康唑白蛋白纳米粒混悬液的处方和制备工艺，考察了白蛋白纳米 粒混悬液的外观形态、粒径分布等理化性质以及体外释药情况。结果 制备的伊曲康唑白蛋白纳米粒混悬液呈圆整的球形或类 球形分布，平均粒径为(108.1±32.8)nm ，PdI为0.205，Zeta 电位为(-47.6± 1.7)mV ；伊曲康唑白蛋白纳米粒在0.5%聚山梨酯-80磷酸 盐缓冲液(pH7.4) 中24h累积释放73.5% 。结论 采用超高压微射流技术制备伊曲康唑白蛋白纳米粒混悬液，工艺简便可行，重现 性好，有望工业化生产。 关键词：伊曲康唑；白蛋白纳米粒混悬液；超高压微射流技术 +5 文献标志码：A 中图分类号：R978.1 Preparation and in vitro evaluation of itraconazole albumin nanoparticle suspensions 1 2 1 Fu Yong-li , Xie Xiang-yang and Luo Ting (1 Department of Pharmacy, Wuhan Mental Health Center, Wuhan 430012; 2 Department of Pharmacy, Wuhan General Hospital of PLA, Wuhan 430012) Abstract Objective To prepare the itraconazole albumin nanoparticle suspensions, optimize the formulation and preparation process, and evaluate the physicochemical characteristics of albumin nanoparticle suspensions. Methods The single factor experimental method was used to study the formulation composition and preparation process of itraconazole albumin nanoparticle suspensions by the ultra-high pressure microfluidization technology. The physicochemical properties of itraconazole albumin nanoparticle suspensions were studied, including morphology and particle size distribution. In vitro release characteristics of itr