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目的:制备F56多肽修饰的长春新碱纳米粒(F56-VCR-NP),并建立其质量控制方法。方法:乳化-溶剂挥发法优化制备F56-VCR-NP;HPLC法测定其载药量、包封率,透射电镜下观察其形态,激光粒度分析仪测定其粒径和Zeta电位,CBQCA试剂盒测定纳米粒表面多肽密度,XPS进行表面元素分析。结果:优化制备的F56-VCR-NP粒径约为153 nm,Zeta电位为-20.8 mv,包封率为21.4%,载药量为1.9%,多肽连接效率为26.3%。结论:以聚乙二醇-聚乳酸(PEG-PLA)为原料,长春新碱为模型药物,成功制备出纳米粒子,并建立起有效的质量控制方法,对该实验样品进行了表征。结果表明此类纳米粒子尺寸均匀,表面多价连接F56多肽,载药量和包封率稳定可控,工艺成熟。
OBJECTIVE: To prepare F56-VCR-NP modified with F56 polypeptide and to establish its quality control method. Methods: F56-VCR-NP was prepared by emulsion-solvent evaporation method. The drug loading and entrapment efficiency were determined by HPLC. Morphology was observed under transmission electron microscope. The particle size and Zeta potential were measured by laser particle size analyzer. The density of nanoparticles on the surface of nanoparticles, surface elemental analysis by XPS. Results: The particle size of optimized F56-VCR-NP was about 153 nm, the zeta potential was -20.8 mv, the encapsulation efficiency was 21.4%, the drug loading was 1.9%, and the polypeptide connection efficiency was 26.3%. Conclusion: Polyethylene glycol-polylactic acid (PEG-PLA) as raw material, vincristine as a model drug, the successful preparation of nano-particles, and establish an effective quality control methods, the experimental samples were characterized. The results showed that these nanoparticles were uniform in size and multivalent on the surface. The drug loading and entrapment efficiency were stable and controllable, and the technology was mature.