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采用Box-Behnken设计-效应面法优化一种微型化介质研磨法制备槲皮素纳米混悬剂(QT-NS)的工艺参数并评价所制得的QT-NS的体外累积释放度。结果显示,以最优工艺参数:氧化锆珠子4.5 m L、研磨速度690 r·min-1、研磨时间1.5 h,制得的QT-NS的粒径为(169±5)nm,多分散度指数为0.204±0.006,稳定系数为0.827±0.014,且理论预测值与实测值偏差较小,模型具有良好的预测性;在120 min体外累积释放度实验中,QT-NS明显高于原料药和物理混合物。使用该种微型化介质研磨法能成功制备QT-NS,且该方法中原料药消耗少,工艺简单、操作方便,可为纳米制剂的制备提供新的参考。
The Box-Behnken design-response surface method was used to optimize the process parameters of quercetin nanosuspension (QT-NS) by using a miniaturized media milling method and to evaluate the in vitro cumulative release of QT-NS. The results showed that the particle size of QT-NS was (169 ± 5) nm and the polydispersity was the highest with the optimum process parameters of 4.5 m L of zirconia beads, 690 r · min-1 of grinding speed and 1.5 h of grinding time The index was 0.204 ± 0.006, the stability coefficient was 0.827 ± 0.014, and the deviation between the theoretical predictive value and the measured value was small, and the model had good predictability. QT-NS was significantly higher than that of API and Physical mixture. QT-NS can be successfully prepared by using the miniaturized medium grinding method, and the method has the advantages of less consumption of raw material medicine, simple process and convenient operation, and can provide a new reference for preparing the nano-preparation.