目的 通过均匀设计法优化姜黄素TPGS/F127/P123混合胶束的处方工艺，以提高姜黄素原料药在水中的溶解度、包封率、载药量，并降低其沉降率。方法 采用改良的薄膜分散法制备姜黄素TPGS/F127/P123混合胶束，在单因素考察的前提下，选取包封率、载药量和沉降率为因变量，姜黄素投药量、TPGS用量和F127/P123比例（质量比）为自变量，进行3因素7水平均匀设计，对实验结果进行多项式线性方程拟合，绘制响应面和等高线图，并对优化后的处方进行验证。结果 最优处方中姜黄素量为14.0 mg，TPGS为150.0 mg，F127/P123比例为68：32。3批验证处方的溶解度为（3.47±0.14）mg/mL，包封率为（87.15±4.39）%，载药量为（4.70±0.17）%，48 h内沉降率为（0.33±0.12）%。结论 姜黄素TPGS/F127/P123混合胶束处方工艺经过均匀设计法优化后，溶解度得到很大程度的提高，包封率和载药量亦得到提高。

Objective The preparation process of curcumin-loaded TPGS/F127/P123 mixed micelles was optimized with uniform design method to improve the poor solubility of curcumin in water, aiming to increase entrapment efficiency (EE), drug-loading (DL), and reduce the precipitated drug (PD). Methods Curcumin-loaded TPGS/F127/P123 mixed micelles were prepared by thin-film hydration method with modification. Before using the uniform design, a number of preliminary experiments were conducted to identify the controlled factors such as the amount of curcumin, the dosage of TPGS, and the ratio of F127/P123. The formulation was operated by uniform design of three factors and seven levels, and its results were fitted by polynomial linear equation, the response surface, and the contour line in order to choose and verify the optimal preparation process. Results In the optimum formulation, the dosage of curcumin was 14.0 mg, TPGS 150.0 mg, and the ratio of F127/P123 was 68:32. The solubility of optimum formulation was (3.47 ±0.14) mg/mL, EE (87.15 ±4.39)%, DL (4.70 ±0.17)%, and PD (0.33 ±0.12)% in 48 h. Conclusion The solubility of curcumin in TPGS/F127/P123 mixed micelles was improved after the optimization of the uniform design method, and EE and DL were also improved.

国家自然科学基金资助项目（81274005）；河北北方学院基金资助项目（GZ1405）