多西紫杉醇微球的质量评价

目的:考察多西紫杉醇微球的质量。方法:应用高效液相色谱(HPLC)分析方法,测定多西紫杉醇微球载药量、包封率,并进行体外释放特性的研究,考察其形态和粒度分布。结果:在设定的色谱条件下,多西紫杉醇与辅料及溶剂峰分离良好,在1~40mg/L浓度范围内,线性关系良好(r=0.9998,n=5);微球呈球形,圆整、表面光滑,平均粒径26.9μm,包封率81.56%,载药量16.32%;体外释放试验表明,其制剂96h体外累积释药百分率为64.44%。结论:该法分析多西紫杉醇微球质量,方法可靠;其微球粒度分布窄,包封率高、缓释作用明显。

Studies on Quality Evaluation of Docetaxel Microspheres

Objective： To evaluate the quality of docetaxel microspheres. Methods： The encapsulation efficiency and drug-loading content of the microspheres were examined by HPLC. The profile of their release in vitro was investigated.The morphology and size of the microspheres were observed. Results： The microspheres were spherical with a smooth surface, the average particle of 26.9μm, the encapsulation efficiency of 81.18%, the drug-loading content of 16.39% and the accumulated release of 64.44% for 96 h. Conclusion： The docetaxel microspheres exhibit a narrow size distribution, high encapsulation efficiency and sustained release behavior in vitro.