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目的:制备注射用葛根素脂质体并测定其包封率。方法:采用薄膜分散-冷冻干燥法制备葛根素脂质体;加入甘露醇作为冻干保护剂;用正交试验优选处方;用透析法分离游离药物;高效液相色谱法测定含量。结果:制得的脂质体平均粒径为296 nm,Zeta电位为-37.5 mV,包封率(72.4±1.6)%(n=3)。在选定的色谱条件下,葛根素与辅料能完全分离,在3.2～72.0μg·ml~(-1)范围内,药物浓度与峰面积呈良好的线性关系,r=0.999 6。结论:薄膜分散-冷冻干燥法适用于制备注射用葛根素脂质体;透析-高效液相色谱法操作简便、准确、重复性好,可用于测定注射用葛根素脂质体的含量和包封率。
Objective: To prepare puerarin liposomes for injection and determine the entrapment efficiency. Methods: The puerarin liposomes were prepared by thin-film dispersion-freeze-drying method; mannitol was added as lyoprotectant; the prescription was optimized by orthogonal test; the free drug was separated by dialysis; the content of puerarin was determined by high performance liquid chromatography. Results: The average diameter of liposomes was 296 nm, the zeta potential was -37.5 mV and the entrapment efficiency was 72.4 ± 1.6% (n = 3). Under the selected chromatographic conditions, puerarin was completely separated from the excipients. There was a good linear relationship between drug concentration and peak area in the range of 3.2 ~ 72.0μg · ml ~ (-1), r = 0.999 6. Conclusion: The method of film dispersion-freeze drying is suitable for the preparation of puerarin liposomes for injection. Dialysis-high performance liquid chromatography is simple, accurate and reproducible. It can be used to determine the content and encapsulation of puerarin liposomes for injection rate.