摘要
目的:制备地塞米松棕榈酸酯脂肪乳注射液,并评价其理化性质。方法:采用热熔乳化-高压均质法制备地塞米松棕榈酸酯脂肪乳注射液,并对脂肪乳的粒径分布、Pd I、Zeta电位和微观形态进行评价;初步考察地塞米松棕榈酸酯脂肪乳注射液的稳定性。结果:制备的地塞米松棕榈酸酯脂肪乳注射液的平均粒径为(215.1±38.2)nm,Pd I为0.218,Zeta电位为(-18.1±2.3)mV;经透射电镜观察显示,地塞米松棕榈酸酯脂肪乳呈球形,大小分布较为均匀;长期稳定性试验结果表明,地塞米松棕榈酸酯脂肪乳注射液在6个月内稳定性良好。结论:采用热熔乳化-高压均质法制备地塞米松棕榈酸酯脂肪乳注射液工艺简单易行,有望应用于工业化生产之中。
Objective： To prepare dexamethasone palmitate lipid emulsion injection and evaluate its physicochemical properties. Methods： Dexamethasone palmitate lipid emulsion injection was prepared by a melt-emulsion and high pressure homogenization method. The physicochemical properties of lipid emulsion were evaluated including the particle size distribution, polydispersity index （PdI） , zeta potential and morphology. And the long term stability was studied as well. Results： The particle size distribution, PdI and zeta potential of dexamethasone pahnitate lipid enmlsion was （215.1 ±38.2） ran, 0.218 and（ -18.1 ±2.3） mV, respectively. The lipid emulsion was found to be spherical with smooth surface as seen under a transmission electron microscope. The long term stability studies showed that the lipid emulsion was stable in 6 months. Conclusion： The preparation technology of dexamethasone palmitate lipid emulsion injection by melt-emulsion and high pressure homogenization method is feasible, which can be used in industrial production.
出处
《中国药师》
CAS
2016年第12期2262-2266,共5页
China Pharmacist
关键词
地塞米松棕榈酸酯
脂肪乳
热熔乳化-高压均质法
Dexamethasone pahnitate
Lipid emulsion
Melt-emulsion and high pressure homogenization method
