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目的:制备伊曲康唑固体脂质纳米粒,并考察其理化性质。方法:采用乳化-低温固化法制备伊曲康唑固体脂质纳米粒(ITZ-SLN);在脂质、表面活性剂等辅料和主药用量的单因素考察基础上,以包封率为评价指标,采用正交试验设计,优化处方组成和制备工艺;用低温超速离心法测定包封率,透射电镜观察形态,激光粒径分析仪测定粒径和ξ电位。结果:脂质、表面活性剂和主药的用量对ITZ-SLN包封率均有不同程度的影响。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,ξ电位(-37.06±0.53)mV,包封率(92.11±1.60)%。结论:乳化-低温固化法制备伊曲康唑固体脂质纳米粒工艺可行。
Objective: To prepare itraconazole solid lipid nanoparticles and investigate the physicochemical properties. Methods: Itraconazole solid lipid nanoparticles (ITZ-SLN) were prepared by emulsification-low temperature curing method. On the basis of the single-factor investigation of the excipients and main drugs, such as lipid, surfactant and so on, The orthogonal design was used to optimize the formulation and preparation process. The entrapment efficiency was determined by cryogenic ultracentrifugation and the morphology was observed by transmission electron microscopy. The particle size and zeta potential were measured by laser particle size analyzer. Results: The dosage of lipid, surfactant and main drug had different degrees of ITZ-SLN encapsulation efficiency. Itraconazole-loaded solid lipid nanoparticles prepared by optimized formulation were spherical-like entities with uniform particle size distribution, average particle size dav = (118.2 ± 15.00) nm, zeta potential (-37.06 ± 0.53) mV, encapsulation Rate (92.11 ± 1.60)%. Conclusion: Emulsion - low temperature curing process of itraconazole solid lipid nanoparticles feasible.