马钱子碱固体脂质纳米粒制备及质量评价

目的：以乳化蒸发-低温固化法制备马钱子碱固体脂质纳米粒并评价其质量。方法：在单因素考察的基础上以正交试验设计优化、筛选最佳处方。用透射电镜观察固体脂质纳米粒的形态，HPLC法测定马钱子碱固体脂质纳米粒的包封率，激光散射测定Zeta电位和粒度分布，并考察其稳定性。结果：所制固体脂质纳米粒外观形态圆整，平均粒径为116nm，Zeta电位为-29．98mv，包封率为50．7％，载药量为2．25％。4℃放置1个月，粒径、包封率无明显变化。结论：本研究制备的马钱子碱固体脂质纳米粒粒径分布窄，稳定性好，为开发马钱子碱低毒长效的制剂奠定了实验基础。

Preparation and Quality Evaluation of Brucine Solid Lipid Nanoparticles

Objective： To prepare brucine solid lipid nanoparticles （Bru-SLN） by means of emulsification-solvent evaporation method and to evaluate its quality. Methods： The formulation of Bru-SLN were optimized by the orthogonal design on the basis of single factor exploration. The morphology was examined by the transmission electron microscope. High-performance liquid chromatography was employed to determine the entrapment rate of Bru-SLN. The diameter, zeta potential and the stability of Bru-SLN were investigated by laser light scattering analysis instrument. Results： The obtained solid lipid nanoparticles were round, smooth particles with average size of 116 nm, zeta potential - 29.98 mV and entrapment rate 50.7%. There were no notable changes of the particle size and entrapment rate at 4℃ within one month. Conclusion： Bru-SLN shows a narrow particle size distribution and good stability, which can be a promising low-toxicity and long-effect preparation.