鬼臼毒素-固体脂质纳米粒凝胶的制备及质量控制

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、十八烷酰胺、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±34·7)nm,包封率为72·5%,pH为7·2±0·3。结论:该制剂制备工艺可行、质量可控。

Preparation and Quality Control of Podophyllotoxin-Loaded Solid Lipid Gel

OBJECTIVE： To prepare podophyllotoxin- loaded solid lipid （PPT- SLN） gel and establish its quality control method. METHODS： With stearic acid, stearylamine, soybean lecithin as cosurfactant and PPT as principal agent, PPT- SLN suspension was prepared by the method of emulsion evaporation and solidification at a low temperature, then prepared into PPT- SLN gel with carbomer used as gel matrix. The physicochemical properties of the preparation were investigated, the content and entrapment efficiency of PPT were determinated by high- performance liquid chromatography （HPLC）, respectively. The stability of the preparation was investigated as well. RESULTS： PPT- SLN gel appeared as lacte translucent semisolid, with its property and test results all in conformity with the related specification in Chinese Pharmacopoia （2005 edition）. The nanoparticles were well- distributed in round or oval shape, with an average particle size of （105.3 ± 34.7） nm, entrapment efficiency of 72.5% and pH value of （7.2±0.3） . The preparation was stable within 6 months under room temperature. CONCLUSION： The preparation technology of PPT-SLN gel is feasible and its quality is controlable.