鬼臼毒素_固体脂质纳米粒凝胶的制备及质量控制.pdf

- # 江中洪 , 曾 抗 , 李国锋, 谷东风, 任 非, 史毓杰( 南方医科大学南方医院, 广州市 510 515) R986;R92 72 A 100 1- 0408( 2008) 16- 1247- 03 目的:制备鬼臼毒素(PPT)- 固体脂质纳米粒(SLN) 凝胶并建立其质量控制方法方法:以硬脂酸十八烷 胺卵磷脂为助 乳化剂,PPT 为主药,采用低温固化- 乳化蒸发法制备成混悬液, 再以卡波姆为基质制备凝胶考察纳米粒的理化性质,采用高效液相 色谱法进行含量分析并计算包封率结果: 所制制剂为乳白色透明状半固体, 性状检查符合2005 年版中国药典的相关规定; 纳米粒 呈圆形或椭圆形,分布均匀,粒径为( 105 3 347) nm, 包封率为725%, pH 为7 2 03结论:该制剂制备工艺可行质量可控 鬼臼毒素- 固体脂质纳米粒; 凝胶; 制备; 质量控制 Preparation and Quality Control of Podophyllotoxin- Loaded Solid Lipid Gel JIANG Zhon - hon , Z NG Kan , LI Guo- fen , GU Don - fen , R N Fei, SHI Yu- ie( Nanfan Hos ital, g g g g g g j g p Southern Medical Universit , Guan zhou 5105 15, China) y g ABSTRACT OBJ CT IV : To prepare podophyllotoxin- loaded solid lipid ( PPT - SLN) gel and establish its quality control methodM THODS: With stearic acid, stear lamine, so bean lecithin as cosurfactant and PPT as rinci al a ent, PPT - y y p p g SLN sus ension was re ared b the method of emulsion eva oration and solidification at a low tem erature, then re ared into p p p y p p p p PPT - SLN el with carbomer used as el matrix T he h sicochemical ro erties of the re aration were investi ated, the g g p y p p p p g content and entra ment efficienc of PPT were determinated b hi h- erformance li uid chromato ra h (HPLC) , res ec p y y g p q g p y p tivel The stabilit of the re aration was investi ated as wellR SULT S: PPT - SLN el a eared as lacte translucent y y p p g g pp semisolid, with its ro ert and test results all in conformit with the related s ec