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目的:制备莪术醇脂质体并进行质量评价。方法:用薄膜-超声分散法制备莪术醇脂质体,以包封率为评价指标,用正交设计法优化处方和工艺,用HPLC法测定莪术醇的含量,并观察其形态、粒径分布和稳定性。结果:制备莪术醇纳米脂质体的最优处方为磷脂:胆固醇的质量比为4∶1,磷脂在水化介质中的浓度为2%,药物:磷脂的质量比为1∶20,水化介质为p H=7.4的磷酸缓冲液;最佳的工艺条件为水化温度为55℃,水化时间为2 h,搅拌时间为30 min,超声时间为2 h。最优处方和最佳的工艺条件制备的脂质体包封率为98.09%,大多为圆形,平均粒径为89.5 nm,在4℃冰箱存放存放3个月后形态和粒径无明显变化,其渗漏率为3.16%。结论:制备的莪术醇脂质体包封率高、粒径小、稳定性好。
Objective: To prepare curcumol liposomes for quality evaluation. Methods: The curcumol liposomes were prepared by the membrane-ultrasonic dispersion method. The encapsulation efficiency was used as the evaluation index. The prescription and technology were optimized by orthogonal design. The content of curcumol was determined by HPLC. The morphology and particle size distribution And stability. Results: The optimal preparation of curcumol nanoliposomes was: the mass ratio of phospholipid to cholesterol was 4:1, the concentration of phospholipid in hydration medium was 2%, the mass ratio of drug to phospholipid was 1:20, The medium was phosphate buffer with p H = 7.4. The optimum conditions were as follows: the hydration temperature was 55 ℃, the hydration time was 2 h, the stirring time was 30 min and the ultrasonic time was 2 h. The best encapsulation efficiency and the optimal process conditions were as follows: the encapsulation efficiency of the liposomes was 98.09%, mostly round, with an average particle size of 89.5 nm. There was no significant change in the morphology and particle size after storing in the refrigerator at 4 ℃ for 3 months , The leakage rate was 3.16%. Conclusion: The prepared curcumol liposomes have high encapsulation efficiency, small particle size and good stability.