CN107198692A - 五加苷元在制备治疗糖尿病药物中的应用 - Google Patents
五加苷元在制备治疗糖尿病药物中的应用 Download PDFInfo
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Abstract
本发明提供了五加苷元的药物新用途，具体地涉及五加苷元在制备治疗糖尿病药物中的应用。本发明还提供了以五加苷元为活性成分的药物组合物。所述五加苷元能够抑制α‑葡萄糖苷酶活性，降低自发性肥胖型糖尿病小鼠的血糖水平，在制备治疗糖尿病的药物上具有广泛的应用。
Description
技术领域
本发明属于医药领域，涉及一种药物新用途，具体地涉及五加苷元在制备治疗糖尿病药物中的应用。
背景技术
糖尿病是以持续高血糖为基本生化特征一种综合病症。主要是由于体内胰岛素相对或绝对不足所引起的糖代谢紊乱所致。糖尿病患者长期高血糖状态可产生多种并发症。临床上用于治疗II型糖尿病的药物主要分为(1)胰岛素及类似物；(2)口服降血糖药：主要有磺酰脲类、双胍类、α-葡萄糖抑制剂和胰岛素增敏剂等药物。西药治疗糖尿病疗效值得肯定。但各种西药降糖药物都有消化道反应、肝肾损害等副作用，且不能有效控制并发症。中医治疗糖尿病疗效稳定，作用温和，不良反应少，能有效预防并发症。因此开发利用天然植物中药成为糖尿病防治药物研究中的热点。
细柱五加(Acanthopanax gracilistylus W.W.Smith)，五加科五加属植物，其干燥根皮入药，为五加皮。其性温。味辛、苦，归肝、肾经，具有祛风湿、补肝肾、强筋骨、通瘀血、里水肿、解热镇痛等功效，临床主要用于治疗风湿痹痛、腰膝酸软、小儿行迟、跌打骨折等。国内外许多学者对细柱五加的化学成分及药理作用进行了研究。研究发现细柱五加叶中含有五加苷、五加苷元等多种三萜类活性成分。其中五加苷元是一个羽扇豆烷型三萜苷元，研究证实其在抗高迁移率族蛋白-1(HMGB1)的活性试验中表现出良好的抗炎活性。但五加苷元制备治疗糖尿病的药理作用未见报道，本发明通过大量的实验研究，发现了五加苷元在制备治疗糖尿病药物中的应用。
发明内容
本发明提供了五加苷元在制备治疗糖尿病药物中的应用。
本发明提供的五加苷元纯度大于等于90％小于100％。
本发明提供了以五加苷元为活性成分的药物组合物在制备治疗糖尿病药物中的应用。
本发明提供的药物组合物根据制剂需要，加入相应辅料，以片剂、丸剂、颗粒剂、糖浆、胶囊形式存在，优选为软胶囊和片剂。本发明提供的各种剂型均可以采用药学常规方法制备而成。
附图说明
图1实施例1五加苷元片剂不同浓度样品α-葡萄糖苷酶的抑制率
图2实施例2五加苷元胶囊不同浓度样品α-葡萄糖苷酶的抑制率
具体实施方式
以下结合具体情况对本发明的具体实施方式做详细说明。
实施例1 五加苷元片剂的制备
处方：
操作：称取处方量的五加苷元、糖粉、乳糖和羧甲基淀粉钠充分混合均匀后过100目筛，加入3％PVPK30水溶液适量制软材，20目筛制粒，60℃干燥3小时，18目筛整粒，加入处方量的硬脂酸镁，混合均匀后压片，每片约200mg，即得。
实施例2 五加苷元胶囊的制备
处方：
操作：称取处方量的五加苷元加羧甲基淀粉钠充分混合均匀后制成软胶囊，每粒约200mg，即得。
实施例3 五加苷元对α-葡萄糖苷酶活性的体外抑制作用
在Bhandari方法基础上进行改进：取pH 6.8磷酸盐缓冲溶液100μL，加入30μL的α葡萄糖苷酶(0.25U)和150μL待测样品溶液，使用阿卡波糖作为阳性对照。充分混合后，将样品在37℃下孵育15min，然后再向反应体系中加入100μL 5mM的4-硝基酚-α-D-吡喃葡萄糖苷(pNPG)溶液，并将混合物在37℃下进一步孵育25min。通过加入300μL 0.1M Na2CO3终止反应。通过葡萄糖氧化酶法测定释放的葡萄糖的量，并在405nm测量吸光度。取实施例1-2的五加苷元片剂和五加苷元胶囊分别配制成待测样品溶液，每个待测样品溶液同时做3个平行，取平均值。
抑制率(％)＝(A对照-A样品)/(A对照-A空白)*100％
实验结果如图1-2所示，50μg/mL的五加苷元均能使α-葡萄糖苷酶的活性降低80.7％以上。
实施例4 五加苷元对自发性肥胖型糖尿病小鼠降血糖试验
实验动物：SPF级，自发性肥胖型糖尿病小鼠(db/db小鼠)40只，6周龄，体重38±2g，随机分组。由湖南斯莱克景达实验动物有限公司提供。
实验药物及仪器：五加苷元(实验室自制)；阳性对照药为马来酸罗格列酮(葛兰素史克天津药业有限公司)，one touch II血糖仪(强生公司)。
动物分组：模型对照组：10只，给等量水；阳性对照组；10只，给阳性药；实验药物组：20只，共分为两组。
给药：分组后适应一周开始给药，连续给药2周，给药途径为灌胃。五加苷元的给药量换算为小鼠后为15mg/kg体重，罗格列酮的给药量为5mg/kg体重。
血糖测定：第7、14天给药1小时后，尾静脉取血用one touch II血糖仪测定动物随即血糖。试验结果见表1。
表1五加苷元各剂型对db/db小鼠血糖浓度的影响
| 动物分组 | 动物数(只) | 7天后血糖浓度(mM) | 14天后血糖浓度(mM) |
| 模型对照组 | 10 | 24.1±2.7 | 26.5±2.5 |
| 阳性对照组 | 10 | 10.1±2.6* | 8.6±2.8* |
| 五加苷元片剂 | 10 | 10.8±2.5* | 9.7±2.9* |
| 五加苷元胶囊 | 10 | 11.8±2.7* | 10.5±2.8* |
注：*P＜0.05，与模型组比较。
表1结果表明五加苷元各剂型对db/db小鼠具有显著的降血糖作用。
以上实施例显示和描述了本发明的基本原理和主要特征以及本发明的优点。本行业的技术人员应该了解，本发明不受上述实施例和实验例的限制，上述实施例和说明书中描述的只是说明本发明的原理，而不是以任何方式限制本发明的范围，在不脱离本发明范围的前提下，本发明还会有各种变化和改进，这些变化和改进都落入要求保护的范围内。
Claims (5)
1.五加苷元在制备治疗糖尿病药物中的应用。
2.根据权利要求1所述的应用，其特征在于，所述五加苷元纯度大于等于90％小于100％。
3.根据权利要求1所述的应用，其特征在于，具体以五加苷元为活性成分的药物组合物在制备治疗糖尿病药物中的应用。
4.根据权利要求3所述的应用，其特征在于，所述药物组合物根据制剂需要，加入相应辅料，以片剂、丸剂、颗粒剂、糖浆、胶囊形式存在。
5.根据权利要求4所述的应用，其特征在于，所述药物组合物为软胶囊及片剂。
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| CN101780070A (zh) * | 2009-01-16 | 2010-07-21 | 广州康臣药物研究有限公司 | 一种治疗糖尿病肾病的药物组合物及其制备方法和应用 |
| KR20120028043A (ko) * | 2010-09-14 | 2012-03-22 | 충남대학교산학협력단 | 신규 트리테르페노이드 및 이의 용도 |
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| KR20120028043A (ko) * | 2010-09-14 | 2012-03-22 | 충남대학교산학협력단 | 신규 트리테르페노이드 및 이의 용도 |
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