多西他赛脂质体冻干粉的制备及质量评价  

Preparation and Quality Evaluation of Docetaxel Lyophilized Liposomes

作　　者：张洪记[1] 丁盛[1] 顾王文[2] 李亚平[2] 陈伶俐[2] 

机构地区：[1]江苏大学药学院,江苏镇江212013 [2]中国科学院上海药物研究所药物释放系统研究中心,上海201203

出　　处：《中国医药工业杂志》2008年第2期113-116,共4页Chinese Journal of Pharmaceuticals

摘　　要：采用薄膜分散法结合冷冻干燥工艺制备多西他赛脂质体冻干品。采用正交试验,以包封率为指标优化处方,并考察了形态、粒径、包封率、体外释放和稳定性。结果表明,按优化处方制得的脂质体冻干品复溶后颗粒呈球形,平均粒径为(167.1±71.2)nm,平均包封率为(85.9±0.6)%;24h累积释放70.3%,释放曲线符合Weibull方程。多西他赛脂质体冻干品4℃放置3个月稳定性良好。Docetaxel liposomes were prepared by film dispersion method and followed by lyophilization. Orthogonal design was adopted to optimize the formulation using encapsulation efficiency as the evaluation parameter. The appearance, size and the distribution, encapsulation efficiency, in vitro release and stability of the products were investigated. The results showed that the dispersed docetaxel lyophilized liposomes were spherical with the mean diameter of （167.1±71.2） nm and the mean encapsulation efficiency of （85.9±0.6） %. The average accumulative release of docetaxel liposomes in vitro was 70.3 % at 24h and the release curve was fitted with Weibull equation. No significant change was found when docetaxel lyophilized liposomes were stored at 4℃ for 3 months.

关 键 词：多西他赛 脂质体 薄膜分散法 冷冻干燥 包封率 体外释放 

分 类 号：R944.9[医药卫生—药剂学]