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目的:制备索拉非尼-Eudragit RS纳米粒(sorafenib-Eudragit RS nanoparticles,S-E NPs),优选制备处方及初步探索其理化性质。方法:溶剂-非溶剂法制备索拉非尼-Eudragit RS纳米粒,采用单因素试验研究溶剂、稳定剂类型、载体比例、有机相水相比例对纳米粒理化性质的影响。通过粒径和Zeta电位、形貌观察、体外释药考察对其进行质量评价。结果:优选处方制备的索拉非尼-Eudragit RS纳米粒的平均粒径为(86.72±3.71)nm,多相分散系数(PDI)为(0.200±0.032),Zeta电位为(36.6±0.3)m V,纳米粒呈球形且分布均匀;体外释放符合Weibull模型(r=0.966 9)。结论:溶剂-非溶剂法适用于索拉非尼-Eudragit RS纳米粒的制备,所制备的纳米粒粒径较小,分布均匀,形态规则完整,具有明显缓释作用。
OBJECTIVE: To prepare sorafenib-Eudragit RS nanoparticles (S-E NPs), and to study the physico-chemical properties of sorafenib-Eudragit RS nanoparticles. METHODS: Sorafenib-Eudragit RS nanoparticles were prepared by solvent-nonsolvent method. The effects of solvent, stabilizer type, carrier ratio and organic phase water phase ratio on the physicochemical properties of nanoparticles were investigated by single factor experiments. Through the particle size and Zeta potential, morphology observation, in vitro release of its quality evaluation. Results: The average particle size of sorafenib - Eudragit RS nanoparticles prepared by the prescription was (86.72 ± 3.71) nm, the PDI was (0.200 ± 0.032) and the zeta potential was (36.6 ± 0.3) m V, the nanoparticles were spherical and evenly distributed; the in vitro release was in accordance with the Weibull model (r = 0.966 9). CONCLUSION: The solvent-nonsolvent method is suitable for the preparation of sorafenib-Eudragit RS nanoparticles. The prepared nanoparticles have the advantages of small size, uniform distribution and complete morphology with a sustained release effect.