维甲酸纳米颗粒混悬剂稳定性的研究

Stability Study on Retinoic Acid Nanosuspensions

研究维甲酸(RA)纳米颗粒混悬剂的稳定性。采用光子相关光谱(PCS)测定了长期放置及冷冻干燥前后混悬剂中纳米粒子的平均粒径和多分散指数(P.I.);用Zeta电位分析仪测定了其Zeta电位,并考察了药物浓度、表面活性剂及pH值对混悬剂稳定性的影响;高效液相色谱法(HPLC)对不同时间混悬剂中全反式维甲酸浓度进行定量测定,绘出了其降解曲线。结果表明,纳米混悬剂的物理稳定性较好,放置及冷冻干燥对其中纳米粒子的粒径及其分布影响不大,其Zeta电位为-33.35±2.7mV,中性环境、无表面活性剂及低药物浓度条件下物理稳定性最好;与溶解状态的维甲酸相比,维甲酸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。

To investigate the stability of retinoic acid （RA） nanosuspensions. Influence of storage and freeze - drying on size and polydipersity index （P.I.） of ATRA nanosuspensions was determined by photon correlation spectroscopy （PCS） method; Zeta potential of nanosuspemion was examined by zeta potential analyzer; the concentratiom of all- tram retinoic acid（ATRA） for different time density were determined by high performance liquid chromatography（HPLC） method. The results show that physical stability of RA nanosuspemion is good, its zeta potential is - 33.35 ± 2.7 mV, which is high enough for sufficient electrostatic stabilization; the degradation rate （percentage of tram - cis transformation） is highly decreased for RA nanosuspension comparing with the reference methanol solution of RA, which means the good chemical stability of RA nanosuspension.