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目的:制备伊曲康唑固体脂质纳米粒(itraconazole solid lipid nanoparticles,ITZ-SLNs)并对其进行物相分析以确定纳米粒的形成。方法:以伊曲康唑(ITZ)为模型药物,硬脂酸为载体材料,采用乳化-低温固化法制备伊曲康唑固体脂质纳米粒(ITZ-SLN),正交试验设计优化处方组成和制备工艺,并对纳米粒的结构形态、粒径、表面电位、包封率、体外释药特性等进行了研究。结果:以优化处方制备的伊曲康唑固体脂质纳米粒为类球形实体,粒径分布比较均匀,平均粒径为dav=(118.2±15.00)nm,Zeta电位为-(37.06±0.53)mV,包封率为(92.11±1.60)%,药物体外释放符合Higuchi方程,经DSC分析证明纳米粒确已形成。结论:伊曲康唑固体脂质纳米粒有望成为新型缓释纳米给药系统。
Objective: To prepare itraconazole solid lipid nanoparticles (ITZ-SLNs) and perform phase analysis to determine the formation of nanoparticles. Methods: Itraconazole solid lipid nanoparticles (ITZ-SLN) were prepared by emulsion-low temperature curing with ITZ as model drug and stearic acid as carrier. The orthogonal design was used to optimize the formulation And preparation process, and the morphology, particle size, surface potential, entrapment efficiency, in vitro release characteristics of the nanoparticles were studied. Results: Itraconazole solid lipid nanoparticles prepared by the optimized formulation were spherulite-like entities with a uniform particle size distribution. The average particle size was (dav = 118.2 ± 15.00) nm and the zeta potential was (37.06 ± 0.53) mV , The entrapment efficiency was (92.11 ± 1.60)%. The in vitro drug release was in accordance with the Higuchi equation. The DSC analysis showed that the nanoparticles had formed. Conclusion: Itraconazole solid lipid nanoparticles is expected to become a new sustained-release nano-drug delivery system.