目的 确定复方桦树茸降糖片的制备工艺，并考察其对2型糖尿病小鼠的降血糖作用。方法 采用热水浸提法提取桦树茸-苦荞（1∶1）、桦树茸、苦荞的粗多糖，采用大孔树脂对粗多糖进行纯化，获得精多糖。以累积溶出率为指标，单因素试验确定复方桦树茸降糖片的制粒方法、甘露醇占填充剂的比例、填充剂比例、湿法制粒的烘干时间，采用BoxBehnken星点设计试验进一步优化其制备工艺。采用高糖高脂喂养联合ip链脲佐菌素（STZ）制备2型糖尿病小鼠模型，考察二甲双胍（5 mg·kg^-1，阳性药）和桦树茸多糖、苦荞多糖、复方桦树茸降糖片（400 mg·kg^-1，以多糖含量计）对2型糖尿病小鼠体质量、空腹血糖、糖化血清蛋白（GSP）水平的影响。结果 优化处方为：桦树茸-苦荞多糖占37%、淀粉占51%、甘露醇占12%，湿法制粒，于60℃下干燥22 min后加1%硬脂酸镁，压片，所得片剂多糖含量为每片58.27 mg。动物实验结果表明，与模型组相比，各给药组小鼠体质量显著升高（P<0.05），空腹血糖显著降低（P<0.01），GSP水平显著降低（P<0.05、0.01）；与桦树茸多糖组及苦荞多糖组比较，复方桦树茸降糖片组小鼠的空腹血糖显著降低（P<0.05），GSP水平显著降低（P<0.05）。结论 复方桦树茸降糖片制备工艺简单，且具有良好降血糖功效。

Objective To determine the preparation process of Compound Inonotus obliquus Hypoglycemic Tablets (CIHT) and to investigate its hypoglycemic effect on type II diabetes mice. Methods The crude polysaccharide compounds of Inonotus obliquustarary buckwheat (1:1), Inonotus obliquus and Tarary buckwheat were firstly extracted by hot water extraction. The crude polysaccharide was purified by macroporous resin to obtain refined polysaccharide. The granulation method, the proportion of mannitol to filling agent, the proportion of filling agent and the drying time of wet granulation were determined by single factor test with the cumulative dissolution rate as the index. Box-Behnken star design experiment was used to further optimize the preparation process. Type II diabetic mouse model was prepared by high-glucose and high-fat feeding combined with streptozotocin ip (STZ), to investigate the effects of metformin (5 mg·kg^-1, positive drug), Inonotus obliquus polysaccharide, Tarary buckwheat polysaccharide and CIHT (400 mg·kg^-1, calculated by polysaccharide content) on body weight, fasting blood glucose and glycated serum protein (GSP) levels. Results The optimized formula was as follows:Inonotus obliquus-Tartary buckwheat polysaccharide accounted for 37%, starch accounted for 51%, mannitol accounted for 12%, wet granulation, dried at 60℃ for 22 minutes, added 1% magnesium stearate and tableted, and the polysaccharide content was 58.27 mg per tablet. Animal experiments showed that, compared with model group, the body weight of mice in each administration group was significantly increased (P<0.05), fasting blood glucose was significantly decreased (P<0.01), and GSP level was significantly decreased (P<0.05, 0.01). Compared with Inonotus obliquus polysaccharide group and Tartary buckwheat polysaccharide group, the fasting blood glucose level and GSP level of mice in CIHT group were significantly decreased (P<0.05). Conclusion The preparation process of CIHT product is simple, and it has good hypoglycemic effect.

R283,R285.5

黑龙江省应用技术研究与开发计划项目（GA19C107）