丹皮酚脂质体的制备及质量控制方法研究

目的:制备丹皮酚脂质体并对其进行质量控制方法研究。方法:采用正交试验优选处方,薄膜-超声法制备丹皮酚脂质体;观察脂质体的形态和粒径,并采用高效液相色谱法对丹皮酚进行含量测定。结果:优选的最佳处方为大豆卵磷脂与胆固醇用量比为4∶1,大豆卵磷脂与丹皮酚用量比为10∶1,维生素E用量为0.1%;制备的丹皮酚脂质体为粒径均一的圆球形结构,平均粒径为359.3nm,包封率为71.55%,渗漏率为1.64%。丹皮酚的检测浓度在8.32～49.92μg·mL-1范围内与峰面积积分值呈良好线性关系(r=0.9999)。结论:制备的丹皮酚脂质体包封率高、渗漏率低,为进一步制备丹皮酚脂质体凝胶奠定了基础。

Preparation of Paeonol Liposome and Its Quality Control

OBJECTIVE： To prepare paeonol liposome and to study its quality control. METHODS： The preparation of paeonol liposome was optimized by orthogonal experiment. Paeonol liposome was prepared by film-ultrasound method. The particle size of the liposome and shape was assessed. The content ofpaeonol in liposome was determined by HPLC. RESULTS： Optimized preparation technology was as follows ： ratio of soybean lecithin to cholesterin was 4 ： 1, ratio of soybean lecithin to paeonol was 10 ： 1, amount of vitamin E was 0.1%. The morphology of liposome was sphere structure with uniform diameter. The average particle size was 359.3 nm and the entrapment efficiency was 71.55%. The rate of leakage was 1.64%. The linear range of paeonol was 8.32-49.92 μg·mL^-1（r= 0.999 9）. CONCLUSION： Prepared paeonol liposome had high entrapment efficiency and low leakage rate, which provide a good foundation for further study of paeonol liposomes gel.