目的 研究以银耳多糖为乳化剂的槲皮素微乳处方和制备工艺。方法 通过溶解度考察、配伍试验和伪三元相图的绘制优选微乳处方；采用银耳多糖为天然乳化剂，以油相、混合乳化剂及助乳化剂比例为考察因素，粒径、载药量及多分散指数（PDI）为评价指标，采用星点设计-效应面法优化槲皮素微乳处方并对其性质、溶出度及稳定性进行评价。结果 槲皮素微乳处方中油相为三乙酸甘油酯（36%）、乳化剂为银耳多糖（23%）和聚山梨酯80（23%），助乳化剂为PEG400（18%）；所得微乳外观均一透明，乳化后平均粒径为（25.04±0.94）nm，Zeta电位为（-13.20±0.68）mV，PDI为0.311±0.030，载药量为（30.17±1.02）mg/g；溶出度实验表明，槲皮素60 min在人工肠液和人工胃液的累积溶出度为87.95%和70.47%；储存稳定性实验、高速离心和高温实验结果表明，微乳的质量稳定。结论 槲皮素微乳制备工艺简单，可以增加槲皮素的溶解度和溶出度，为相关制剂的进一步研究与开发提供参考。

Objective To study the prescription and preparation process of quercetin microemulsion containing Tremella fuciformis polysaccharide as emulsifier. Methods The prescription was optimized through solubility investigation, compatibility test and ternary phase diagram method. T. fuciformis polysaccharide was used as natural emulsifier, the ratio of oil phase, mixed emulsifier and co-emulsifier were used as the examination factors, and particle size, drug loading capacity and polydispersity index (PDI) were used as evaluation indicators. The central composite design-response surface method was used to optimize the formulation of quercetin microemulsion and evaluate its properties, dissolution and stability. Results The oil phase of the quercetin microemulsion prescription was glycerol triacetate (36%), the emulsifier was T. fuciformis polysaccharide (23%) and T80 (23%), and the co-emulsifier was PEG400 (18%); The resulting microemulsion had uniform and transparent appearance; The average particle size was (25.04 ±0.94) nm, the potential was (−13.20 ±0.68) mV, the PDI was 0.311 ±0.030, and the drug loading was (30.17 ±1.02) mg/g. The dissolution test showed that the cumulative dissolution rate of quercetin in simulated intestinal fluid and simulated gastric fluid at 60 min was 87.95% and 70.47%. Preliminary stability test, high-speed centrifugation and high-temperature test results showed that the quality of microemulsion was stable. Conclusion The preparation process of quercetin microemulsion is simple, which can increase the solubility and dissolution of quercetin, and provide reference for further research and development of related preparations.

R283.6

国家自然科学基金项目（81750110548）