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目的：：制备辛伐他汀纳米结构脂质载体(辛伐他汀-NLCs )。方法：采用热熔乳化超声-低温固化法制备辛伐他汀-NLCs,以辛伐他汀-NLCs粒径分布、多聚分散系数( PdI)、包封率和载药量为评价指标,考察了制备辛伐他汀-NLCs的固体与液体脂质比例、脂质浓度、表面活性剂与助表面活性剂比例、乳化剂浓度、药物浓度等处方因素,并对制得的最优辛伐他汀-NLCs处方进行表征；考察辛伐他汀-NLCs的体外释药行为及稳定性。结果：辛伐他汀-NLCs的最优处方为：辛伐他汀浓度为0.5%,鲸蜡醇棕榈酸酯浓度为1.5%,辛酸/癸酸甘油酯浓度为4.5%,大豆卵磷脂浓度为2.5%,聚乙二醇-12-羟基硬脂酸酯浓度为1.5%；制得的3批辛伐他汀-NLCs平均粒径为(102.2±42.1)nm,PdI为(0.201±0.023),Zeta电位为(-33.1±4.1)mV,透射电镜显示成圆整、规则球形,24 h累计释放度为(59.1±4.8)%；稳定性研究显示,辛伐他汀-NLCs在5℃条件下放置3个月稳定。结论：该处方可用于辛伐他汀-NLCs的制备,工艺可行。“,”To prepare simvastatin nanostructured lipid carriers ( simvastatin-NLCs) . Methods:The simvastatin-NLCs were prepared by melt-emulsion ultrasonication and low temperature-solidification methods. Using the particle size, polydispersion in-dex, encapsulation efficiency and drug loading as the idices, the ratio of solid to liquid, lipid concentration, ratio of surfactant to cosur-factant, emulsifier concentration and drug concentration were optimized. The optimized simvastatin-NLCs were characterized for the en-capsulation efficiency, particle size, zeta potential and morphology. In vitro drug release behavior and stability of NLCs were also stud-ied. Results:The optimized simvastatin-NLCs formula was as follows:the concentration of simvastatin, cetyl palmitate, Miglyol? 812, soy lecithin and solutol HS15? was 0. 5%, 1. 5%, 4. 5%, 2. 5% and 1. 5%, respectively. The particle size and zeta potential of NLCs was (102. 2 ± 42. 1) nm and ( -33. 1 ± 4. 1) mV, respectively. The simvastatin-NLCs were found to be small and spherical with smooth surface under a transmission electron microscope. The in vitro release profile indicated that the accumulated release of sim-vastatin reached up to (59. 1 ± 4. 8) % in 24 h. The stability studies showed that simvastatin-NLCs were stable in 3 months after stored at 5℃. Conclusion:The formula of simvastatin-NLCs prepared by melt-emulsion ultrasonication and low temperature-solidifica-tion method is feasible.