熊果酸脂肪乳注射液的制备及体外评价

Preparation and in vitro evaluation of ursolic acid lipid emulsion injection

目的:制备熊果酸脂肪乳注射液,并对其理化性质进行评价。方法:采用高压均质法制备熊果酸脂肪乳注射液,考察脂肪乳的粒径分布、Zeta电位和微观形态,并初步研究熊果酸脂肪乳的稳定性。结果:熊果酸脂肪乳注射液的平均粒径为(203.6±37.1)nm,Zeta电位为(-36.5±3.6)mV;透射电镜显示脂肪乳注射液粒径均一,呈球状分布。稳定性研究结果表明,熊果酸脂肪乳在25℃/60%条件下放置6个月内稳定。结论:高压均质法制备熊果酸脂肪乳注射液工艺简单易行,有望应用于工业化生产。

OBJECTIVE To prepare ursolic acid lipid emulsion injection and evaluate its physicochemical properties.METHODS Ursolic acid lipid emulsion injection was prepared by high pressure homogenization methods.Lipid emulsion was evaluated by various physicochemical properties,such as particle size distribution,Zeta potential and morphology.Long term stability was studied.RESULTS Particle size distribution and Zeta potential of ursolic acid lipid emulsion were（203.6±37.1）nm and（-36.5±3.6）mV,respectively.Lipid emulsion was small and spherical with smooth surface as seen under transmission electron microscope.Long term stability study showed that lipid emulsion was stable for up to 6 months after storage at 25 ℃/60%.CONCLUSIONThe preparation technology of ursolic acid lipid emulsion injection by high pressure homogenization methods is feasible,and the technology can be used in industrial production.