利用Box-Behnken效应面法优化氟苯尼考纳米混悬剂处方

为了优化制备氟苯尼考纳米混悬剂,使用介质研磨法制备氟苯尼考纳米混悬剂,以粒径、多分散系数为评价指标,采用Box-Behnken设计-效应面法评价氟苯尼考纳米混悬剂的处方,并进行验证,用HPLC法测定氟苯尼考纳米混悬剂的含量。结果显示,最优处方为药物浓度为10.12%、HPMC浓度为11.88 mg/m L、SDS浓度为1 mg/m L。制得的氟苯尼考纳米混悬剂的粒径、多分散系数、含量分别为(264.57±5.37)nm、0.176±0.004、(10.67±0.12)%,与模型理论预测值接近。结果表明,Box-Behnken效应面法适用于氟苯尼考纳米混悬剂的处方优化,且具有良好的预测性。

Optimizations of the formulation of florfenicol nanosuspension by Box-Behnken design response surface method

To optimize the formulation,florfenicol nanosuspension was prepared by wet media milling method.The average particle size(PS),polydispersity index(PDI)were set as indices.Box-Behnken design response surace method was used to evaluate the formulation of florfenicol nanosuspension.The predictive data were validated.HPLC method was used to determine the content of florfenicol nanosuspension.The results show that the concentration of florfenicol nanosuspension,HPMC and SDS according to the optimized formulation was 10.12%,11.88 mg/m L and 1 mg/m L,respectively.The PS,PDI and content of florfenicol nanosuspension was(264.57±5.37)nm,0.176±0.004,(10.67±0.12)%,which was close to the theoretical prediction value of the model.In conclusion,Box-Behnken design response surface method was suitable for the formulation optimization of florfenicol nanosuspension and had good predictability.