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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。
Objective: To investigate the quality of docetaxel microspheres. Methods: The drug loading and entrapment efficiency of docetaxel microspheres were determined by high performance liquid chromatography (HPLC), and the release characteristics of docetaxel microspheres were investigated. The morphology and particle size distribution were investigated. Results: Under the chromatographic conditions, docetaxel was well separated from its excipients and solvent peaks. The linearity was good (r = 0.9998, n = 5) in the range of 1 ~ 40mg / L. The whole surface was smooth and the average particle size was 26.9μm. The entrapment efficiency was 81.56% and the drug loading was 16.32%. The in vitro release test showed that the cumulative release percentage of the preparation in 96h was 64.44%. CONCLUSION: This method can be used to analyze the quality of docetaxel microspheres and the method is reliable. The microspheres have narrow particle size distribution, high entrapment efficiency and slow release.