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目的制备克林霉素磷酸酯脂质体并测定包封率及粒径。方法采用蒸发超声法制备克林霉素磷酸酯脂质体,高效液相色谱法检测克林霉素磷酸酯包封率,用激光粒度仪测定其平均粒径。结果运用正交设计方法,优化脂质体的制备工艺和处方为:磷脂:胆固醇为5∶1,超声时间为6min,蒸发温度为35℃,磷脂:克林霉素为5∶3,磷脂:海藻糖为2∶1。克林霉素磷酸酯在5.0～50μg/mL范围内线性关系良好。3组克林霉素磷酸酯脂质体包封率分别为52.26%、50.13%和53.75%。结论克林霉素磷酸酯脂质体制备工艺可行,质量控制方法简单、准确。
Objective To prepare clindamycin phosphate liposomes and determine the entrapment efficiency and particle size. Methods Clindamycin phosphate liposomes were prepared by evaporation and ultrasonication. The encapsulation efficiency of clindamycin phosphate was detected by high performance liquid chromatography (HPLC). The average particle size was determined by laser particle sizer. Results The orthogonal design method was used to optimize the preparation process and prescription of liposomes: phospholipid: cholesterol 5: 1, ultrasonic time 6 min, evaporation temperature 35 ℃, phospholipid: clindamycin 5: 3, phospholipid: Trehalose is 2: 1. Clindamycin phosphate in the range of 5.0 ~ 50μg / mL good linear relationship. The encapsulation efficiencies of three clindamycin phosphate liposomes were 52.26%, 50.13% and 53.75% respectively. Conclusion Clindamycin phosphate liposome preparation process is feasible, quality control method is simple and accurate.