藏药EH复方降糖颗粒处方筛选及产品稳定性研究  

Prescription screening and product stability of Tibetan medicine EH compound hypoglycemic granule

作　　者：李艳[1] 毛羽[1] 杨邦祝 沈睿娟 杜朗宇[1] 林灵敏 雷敏 谢雨蕉 

机构地区：[1]西南民族大学少数民族药物研究所,四川成都610041 [2]炉霍雪域俄色责任有限公司,四川甘孜州626500 [3]炉霍县林业局,四川甘孜州626500

出　　处：《西南民族大学学报（自然科学版）》2016年第2期162-169,共8页Journal of Southwest Minzu University(Natural Science Edition)

基　　金：四川省农业科技成果转化资金项目"雪域俄色茶产业化生产示范"(14NZ0015)

摘　　要：目的：结合中、藏医药理论将藏药材ES与黄芪、麦冬、枸杞子、山药等中药进行组方配伍,运用降糖活性评价筛选其制剂处方,并确立藏药EH复方降糖颗粒制剂的最佳成型工艺,并考察其稳定性.方法：考察了水提液、醇提液对肾上腺素模型组小鼠血糖的影响,以吸湿性、溶解度、成型率为指标,筛选出处方中加入辅料的品种、配比及最佳成型工艺,以高温、高湿、强光照射及加速试验对颗粒剂进行稳定性考察.结果：藏药EH复方水提液及醇提液对肾上腺素所致的小鼠高血糖具有明显的降糖作用,以水提液高剂量组为佳;同时,最佳制粒成型工艺：将药液浓缩至相对密度1.28~1.30（60℃）的稠膏,加入1.3倍的可溶性淀粉-糊精（1：1）,混合,制软材,用10目筛挤压制粒,升温到40℃下先干燥30 min,然后升温到50℃,保持2 h,取出后过一号筛和四号筛整粒,密封即得.该制剂在60℃、相对湿度75%、照度4000Lx的条件下,颗粒剂中黄芪甲苷的含量受温度、湿度及光照的影响较大,采用密封性及遮光性较好的铝塑复合袋包装后,加速稳定性试验表明成品质量基本稳定.结论：藏药材ES与中药组方制备成颗粒制处方合理,成型制备工艺可行,对肾上腺素致小鼠高血糖具有明显的抑制作用,且颗粒剂稳定性良好.Objective：To establish Tibetan medicine EH hypoglycemic granule preparation of compound molding process,and investigate its stability. Tibetan medicine ES and Chinese medicine（ Astragalus,Radix,Medlar,Yams） were composed,and the pharmaceutical formulations were screened by using of hypoglycemic activity evaluation. Methods：The effects of water extraction and alcohol extraction were examined on blood sugar of epinephrine model group mice. Based on hygroscopicity,solubility and forming rate,the preparation process,the variety and proportion of the excipients were screened out,and established the stability study method of the granule preparation by high temperature,high humidity,strong light irradiation and acceleration tests. Results：Tibetan EH compound water extract and alcohol extract for adrenaline-induced hyperglycemic mice had obvious hypoglycemic effect,water extract high-dose group was better;At the same time,the perfect granulating process was：thickening liquid to relative density 1. 28 to 1. 30（60 ℃）,adding 1. 3 times soluble starch- dextrin（1：1）,mixing into soft material,using10 mesh sieve extruded granulating,the temperature was raised to 40 ℃ and dried for 30 min,then heated to 50 ℃,holding 2h,taking out after the fourth sieve and one sieve granulated,sealed. Under the conditions of 60 ℃,relative humidity of 75%,illumination 4000 Lx,the astragaloside content in the pharmaceutical was greatly influenced by temperature,humidity and light. Packaged by sealing and shading aluminium plastic composite bag,the results of accelerated stability test showed that the product quality was stable. Conclusion：The ES Tibetan medicine and traditional Chinese medicine prescription prepared granules is reasonable,the molding process is feasible,it has obvious inhibitory effect on adrenaline-induced hyperglycemic mice,and the stability of granules is good.

关 键 词：俄色 EH降糖颗粒 成型工艺 2型糖尿病 

分 类 号：R28[医药卫生—中药学] R29[医药卫生—中医学]