目的 確定復方樺樹茸降糖片的制備工藝，并考察其對2型糖尿病小鼠的降血糖作用。方法 采用熱水浸提法提取樺樹茸-苦蕎（1∶1）、樺樹茸、苦蕎的粗多糖，采用大孔樹脂對粗多糖進行純化，獲得精多糖。以累積溶出率為指標，單因素試驗確定復方樺樹茸降糖片的制粒方法、甘露醇占填充劑的比例、填充劑比例、濕法制粒的烘干時間，采用BoxBehnken星點設計試驗進一步優(yōu)化其制備工藝。采用高糖高脂喂養(yǎng)聯(lián)合ip鏈脲佐菌素（STZ）制備2型糖尿病小鼠模型，考察二甲雙胍（5 mg·kg^-1，陽性藥）和樺樹茸多糖、苦蕎多糖、復方樺樹茸降糖片（400 mg·kg^-1，以多糖含量計）對2型糖尿病小鼠體質量、空腹血糖、糖化血清蛋白（GSP）水平的影響。結果 優(yōu)化處方為：樺樹茸-苦蕎多糖占37%、淀粉占51%、甘露醇占12%，濕法制粒，于60℃下干燥22 min后加1%硬脂酸鎂，壓片，所得片劑多糖含量為每片58.27 mg。動物實驗結果表明，與模型組相比，各給藥組小鼠體質量顯著升高（P<0.05），空腹血糖顯著降低（P<0.01），GSP水平顯著降低（P<0.05、0.01）；與樺樹茸多糖組及苦蕎多糖組比較，復方樺樹茸降糖片組小鼠的空腹血糖顯著降低（P<0.05），GSP水平顯著降低（P<0.05）。結論 復方樺樹茸降糖片制備工藝簡單，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

黑龍江省應用技術研究與開發(fā)計劃項目（GA19C107）