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目的:对泊那替尼纳米混悬剂的表面活性剂的筛选及其稳定性研究。方法:采用聚乙烯吡咯烷酮(PVP K30)、泊洛沙姆P188、聚乙烯醇、磷脂和聚山梨酯-80为表面活性剂制备的泊那替尼纳米混悬剂;利用激光纳米粒度仪测定长期放置混悬剂中纳米粒子的平均粒径和多分散系数(PDI),Zeta电位分析仪测定其Zeta电位,高效液相色谱法(HPLC)对不同时间混悬剂中泊那替尼的浓度进行定量测定,绘出其降解曲线。结果:通过形态观察,以PVP K30为表面活性剂制备的混悬剂大小均匀、有乳光,且无针状结晶析出;与溶解状态下的泊那替尼相比,泊那替尼纳米混悬剂的化学稳定性显著改善,有效药物浓度的降解速度明显降低。结论:采用PVP K30为表面活性剂制备的混悬剂稳定性较好,有望成为泊那替尼的新型纳米给药系统。
OBJECTIVE: To screen the surfactants of polantatin nanosuspension and study on its stability. Methods: The polantin nanosuspension was prepared by using polyvinylpyrrolidone (PVP K30), poloxamer P188, polyvinyl alcohol, phospholipid and polysorbate-80 as surfactant. The long-term The average particle size and polydispersity (PDI) of the nanoparticles in the suspension were measured. Zeta potential was measured by Zeta potential analyzer. The concentration of polantatin in the suspension was quantified by high performance liquid chromatography (HPLC) Determination, draw the degradation curve. Results: Morphological observation showed that the suspension prepared with PVP K30 as surfactant had uniform size and opalescence with no needle-like crystals. Compared with the povidone-dissolved povidone The chemical stability of the suspension significantly improved, the effective drug concentration degradation rate significantly reduced. CONCLUSION: The suspension prepared with PVP K30 as surfactant has good stability and is expected to become a new nano-drug delivery system of polantinib.