目的 根据"药辅合一"理念，从中药白及中提取白及多糖（BSP），制备多孔性白及胶（BSPG），并分析多孔性BSPG的辅料特性，对其作为功能性辅料的可行性进行初步评价，为制剂学设计提供理论依据。方法 白及药材经脱脂、红外辅助水提、Sevage法脱蛋白、分级醇沉、冷冻干燥得到多孔性BSPG；采用分级乙醇法，分别以乙醇体积分数40%、60%、80%进行醇沉，以获得不同BSP组分（BSPG40、BSPG60、BSPG80）；采用冷冻干燥法制备多孔性BSPG，利用质构仪测定多孔性BSPG固体和凝胶特性，比较各样品的辅料特性；以十八醇为轻质辅料，以多孔性BSPG为原料，采用全粉末直接压片，制备多孔性BSPG空白片以及非多孔性BSPG空白片，测定其在人工胃液中的漂浮性、吸水率、溶胀性、降解性能，对其作为漂浮型和生物黏附型胃滞留制剂功能性辅料的可行性进行研究。结果 红外辅助提取BSP各醇沉样品BSPG40、BSPG60、BSPG80的总多糖质量分数分别为69.33%、57.64%、42.83%，BSPG40、BSPG60、BSPG80所占比例分别为83.25%、12.16%、4.49%。BSPG80提取率低，且凝胶特性较弱，因此针对BSPG、BSPG40、BSPG60样品进行性能分析。经冷冻干燥后，BSPG、BSPG40、BSPG60样品均呈现疏松多孔的性状，各样品硬度随质量浓度的增加而逐渐增大，在相同质量浓度时，各个样品硬度表现为BSPG > BSPG40 > BSPG60，而蓬松度随着硬度的增加逐渐减小，且BSPG、BSPG40、BSPG60分别为15、20、20 mg/mL时冻干样品的回弹性较好。分级醇沉样品凝胶强度和黏附力均随着质量浓度的增加而增大，黏附力表现为BSPG40 > BSPG > BSPG60。初步实验表明，多孔性BSPG具有快速起漂、长时间漂浮、吸水性能好和缓释的性能。结论 不同体积分数乙醇沉淀使样品具有不同的辅料特性，且同一体积分数乙醇沉淀样品的质量浓度又影响其液体特性和冷冻干燥后的固体特性，同时多孔性BSPG是一种潜在的胃滞留漂浮型缓控释制剂辅料。因此，该研究为BSPG作为功能性辅料的研究提供了理论上的依据，对新型辅料的开发具有重要的意义。

Objective Guided by the thought of unification of drug and adjuvant, Bletilla striata polysaccharides gum (BSPG) was got from traditional Chinese medicine of Bletilla striata. Methods In this research, the porous BSPG was prepared and its functional properties in solid and gel states were characterized by using infrared-assisted extraction, ethanol fractionation precipitation, freeze drying, and texture analyzer. BSPG40, BSPG60, and BSPG80 were fractionated by repeated precipitation method, using 40%, 60%, and 80% ethyl alcohol as precipitant and these polysaccharides content were determined with Phenylhydrate-Sulfuric acid. Octadecanol as the adjunct and the porous BSPG as the material, porous and non-porous tablets were prepared by direct compression method. The capabilities of floating, water absorption, expansibility, and the degradation performance were measured in artificial gastric juice to give an initial research on the feasibility that the porous BSPG can be used as adjuvant. Results It showed that the total polysaccharide content of BSPG, BSPG40, BSPG60, and BSPG80 was 64.15%, 69.33%, 57.64%, and 42.83%, respectively and the yield of BSPG40, BSPG60 and BSPG80 account for 83.25%, 12.16%, and 4.49%. BSPG80 is too little to get and exhibits typical "weak gel" properties, so properties of BSPG, BSPG40, BSPG60 were tested. By freeze drying, all samples were loose and porous. Hardness increased as the concentrations increased, and at equal concentrations, the hardness of BSPG, BSPG40, and BSPG60 gradually increased but filling power gradually decreased as the hardness increased. Elasticity of BSPG, BSPG40, and BSPG60 is better at the concentration of 15, 20, and 20 mg/mL respectively. While gel strength and adhesion of BSPG, BSPG40, and BSPG60 was gradually weaken. This study's preliminary experiments indicated that tablets of porous BSPG had good ability of floating, water absorption, expansibility and the degradation performance. Conclusion The experiment results showed that different concentration of ethanol fractionation precipitation exercises a great influence on the texture properties and at the same time, different concentration of BSPG which obtained by the same concentration of ethanol fractionation precipitated has different texture properties and low concentrations of ethanol fractionation precipitated had better performance of hardness, filling power, gel strength, adhesion and played a better role in pharmacy. Besides, porous BSPG is a potential excipient of floating to prolong the gastric retention time. Therefore, this study provided important theoretical evidence and made great significance to future exploration and development of the new excipient of porous BSPG.

国家自然科学基金青年基金——基于胃内流体动力模拟的"药辅合一"多孔性白及胶胃内滞留行为及机制研究（81603309）；四川省科技厅应用基础项目——多孔性白及胶作为胃滞留制剂功能性辅料的研究（2015JY0139）