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目的:研制洛伐他汀脂质体,考察其制备的影响因素,优化处方工艺,并对其特性进行表征。方法:采用薄膜分散法制备洛伐他汀脂质体,以包封率、粒径和Zeta电位为指标参数,考察表面活性剂、水合介质及药脂比对其制备的影响;并评价其理化性质及稳定性。结果:以脱氧胆酸钠-泊洛沙姆188(1∶2)为表面活性剂、去离子水为水合介质和药脂比为1∶40制备的洛伐他汀脂质体具有最佳的包封率(>90%)、粒径(90～110 nm,分布系数为0.32)和Zeta电位(-35～-39 mV);其外观圆整,内部具指纹状结构;在4℃下放置30 d,包封率、粒径及Zeta电位均无明显变化。结论:采用薄膜分散法制备的洛伐他汀脂质体具有良好的理化特性及稳定性。
OBJECTIVE: To develop lovastatin liposomes, investigate the factors influencing their preparation, optimize the formulation process and characterize them. Methods: Lovastatin liposomes were prepared by membrane dispersion method. The entrapment efficiency, particle size and Zeta potential were used as index parameters to investigate the effects of surfactant, hydration medium and drug-lipid ratio on their preparation. The physicochemical properties And stability. RESULTS: Lovastatin liposomes prepared with sodium deoxycholate-poloxamer 188 (1: 2) as surfactant, deionized water as hydration medium and drug-lipid ratio 1:40 had the best package (> 90%), particle size (90-110 nm, distribution coefficient 0.32) and Zeta potential (-35-39 mV); its appearance is round and its interior has finger-like structure; d, no significant changes in the encapsulation efficiency, particle size and Zeta potential. Conclusion: Lovastatin liposomes prepared by membrane dispersion method have good physical and chemical properties and stability.