目的通过Box-Behnken试验设计(BBD)法优化人参皂苷Rg_3自乳化制剂的处方配比,并对其质量进行评价。方法采用3因素3水平BBD,以乳化剂、助乳化剂和油相为主要因素进行考察,载药量和平均粒径为响应值,用BBD软件绘制响应面图并得到各考察因素对指标影响的多项式,最终得到优化的处方配比,通过对自乳化效率、粒径、溶出度等方面进行体外评价。结果人参皂苷Rg_3自乳化制剂最优处方的乳化剂为[RH40-Triton X100(1∶1)],助乳化剂为异丙醇,油相为油酸乙酯,最优比例为3∶1.475∶0.5;优化后制备的制剂5 min内乳化完全,平均载药量为917.53μg/m L,平均粒径为111.6 nm,且体外溶出度试验表明其释药速度与程度明显优于市售的胶囊剂。结论 BBD法用于人参皂苷Rg_3自乳化制剂的处方优化是可行的,数学模型的预测值与实验观察值相符。 OBJECTIVE To optimize the prescription ratio of ginsenoside Rg_3 self-emulsifying formulation by Box-Behnken experimental design (BBD) method and evaluate its quality. Methods The BBD of 3 factors and 3 was used to study the emulsifier, emulsifier and oil phase as the main factors. The drug loading and the average particle size were used as the response values. The response surface map was drawn by BBD software and the influence of each factor on the index Of the polynomial, and ultimately optimized prescription ratio, through the self-emulsifying efficiency, particle size, dissolution and other aspects of in vitro evaluation. Results The optimal formulation of ginsenoside Rg_3 self-emulsifying formulation was [RH40-Triton X100 (1: 1)], the co-emulsifier was isopropanol, and the oily phase was ethyl oleate. The optimum ratio was 3:1.475: 0.5; the optimized preparation was completely emulsified within 5 min with an average drug loading of 917.53 μg / mL and a mean particle size of 111.6 nm, and the in vitro dissolution test showed that the drug release rate and degree were significantly better than the commercially available capsules Agent. Conclusion The BBD method for ginsenoside Rg_3 self-emulsifying formulations prescription optimization is feasible, the mathematical model predictions and experimental observations consistent.