共载伊立替康-姜黄素复合脂质体的制备与分析

Preparation and Analysis of Compound Liposome of Irinotecan and Curcumin

目的:制备共载伊立替康-姜黄素复合脂质体,并对其关键质量指标进行评价。方法:采用薄膜分散-主动载药技术制备复合脂质体,建立HPLC法测定复合脂质体含量及包封率,采用动态光散射法测定粒度分布,气相色谱法测定有机溶剂残留。结果:伊立替康-姜黄素复合脂质体包封率分别为伊立替康99.53%、姜黄素98.31%,平均粒径为(114.6±1.8)nm,多项分散系数(Pd I)小于0.20,Zeta电位为(-7.53±0.51)m V;所制得样品于5℃±3℃条件下放置6个月,各项考察指标均未发生明显变化。结论:该方法适合伊立替康-姜黄素复合脂质体的制备,所建立质控方法简单、准确,适合对该复合脂质体的性质进行评价。

Objective： To prepare compound liposome loading of irinotecan and curcumin, and evaluate its pharmaceutical properties. Methods： Film dispersion-active drug-loading technology was used to entrap irinotecan and curcumin for preparing compound liposome. HPLC method was established to determine irinotecan and curcumin. The mean diameter of liposomes was determined by dynamic light scattering（DLS） techniques. Residual organic solvents were analyzed by gas chromatograph. Results： The EE of compound liposome loading of irinotecan and curcumin was 99.53% and 98.31% respectively. The mean diameters of compound liposome were（114.6±1.8） nm and its Pd I was below 0.20 and its Zeta potential was（-7.53±0.51） m V. The inspection indexes of compound liposome did not change significantly at six-month storage test（5℃ ±3℃）. Conclusion：The established method is fit for the preparation of compound liposome of irinotecan and curcumin. The analysis method is simple and accurate, which can be used to evaluate the property of compound liposome.