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目的:优化紫杉醇聚乳酸-羟基乙酸(PLGA)纳米粒处方和制备工艺。方法:以PLGA为载体,采用溶剂扩散法制备紫杉醇PLGA纳米粒,用3~2满因子设计实验,考察因素PLGA在有机相中的浓度和理论载药量对纳米粒的粒径、载药量和包封率的影响,实验数据分别采用线性方程和二次多项式拟合,根据最佳数学模型绘制效应面并选出最优处方。结果:2个影响因素和3个评价指标之间存在定量关系,最优处方为:紫杉醇的理论载药量为9.09%、有机相中PLGA浓度为2%,制备得到的纳米粒粒径为281 nm,实际载药量为7.73%,包封率为57.43%。结论:采用因子设计-效应面法完成了紫杉醇纳米给药系统的多目标同步优化。
Objective: To optimize the formulation and preparation of paclitaxel polylactic acid - glycolic acid (PLGA) nanoparticles. Methods: Paclitaxel PLGA nanoparticles were prepared by solvent diffusion method using PLGA as carrier. The experiment was conducted with 3 ~ 2 full factorial design. The concentration of PLGA in the organic phase and the theoretical drug loading were investigated. And the entrapment efficiency. The experimental data were fitted with linear equation and quadratic polynomial respectively. The effect surface was drawn according to the best mathematical model and the optimal prescription was selected. Results: There was a quantitative relationship between the two influencing factors and the three evaluation indexes. The optimal prescription was: the theoretical drug loading of paclitaxel was 9.09%, the concentration of PLGA in the organic phase was 2% and the particle size of prepared nanoparticles was 281 nm, the actual drug loading was 7.73%, encapsulation efficiency was 57.43%. Conclusion: The multi-objective synchronization optimization of paclitaxel nano-drug delivery system was accomplished by factor design-response surface method.