CN107875350B - 一种治疗糖尿病的药物组合物 - Google Patents
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Abstract
本发明涉及药物学领域,尤其涉及一种治疗糖尿病的药物组合物。本发明药物组合物是由泡桐果提取物、烟酸铬、姜黄根提取物、盐酸小檗碱和绿咖啡豆提取物组成的。经药理和毒理实验证实,在小鼠糖尿病模型中,本发明药物组合物具有非常理想的降血糖效果,且服用安全性良好。此外,本发明药物组合物可制成多种口服剂型,便于携带和服用。
Description
技术领域
本发明涉及药物学领域,尤其涉及一种治疗糖尿病的药物组合物。
背景技术
糖尿病是由遗传和环境因素相互作用而引起的一组代谢异常综合征。因胰岛素分泌、胰岛素作用或两者同时存在缺陷,引起碳水化合物、蛋白质、脂肪、水和电解质等的代谢紊乱,临床以长期高血糖为主要共同特征。长期糖尿病可引起多个系统器官的慢性并发症,导致功能障碍和衰竭,成为致残、致死的主要原因。
由于糖尿病的病因和发病机制尚未完全明了,因此目前还缺乏有效的病因治疗方法。现在临床上对糖尿病的治疗多采用胰岛素治疗和口服降糖药物治疗,然而糖尿病属于一种终身性疾病,需要长期用药,胰岛素的注射给药方法往往会给患者带来许多不便,而临床常用的口服降糖药物多属于化学药品,长期服用也会引发一系列的不良反应。
发明内容
本发明人在研究中发现,将泡桐果的酸提物与具有降血糖作用的烟酸铬、盐酸小檗碱按照一定比例配伍,再辅以姜黄根提取物、绿咖啡豆提取物等成分组成的药物组合物,具有很好的降血糖作用,与单独使用烟酸铬和盐酸小檗碱等成分相比,其疗效明显提升。
泡桐果为玄参科植物毛泡桐或泡桐的成熟果实,是一种常见的传统中药材,其味苦,性微寒,归肺经。具有化痰、止咳、平喘的功效,可用于治疗慢性支气管炎、咳嗽咯痰等症。泡桐果中含有桐酸、脂肪油及多种黄酮类物质。但目前为止,尚未见到利用泡桐果治疗糖尿病的相关报道。
本发明治疗糖尿病的药物组合物,是由下述重量份的原料制成的:
泡桐果提取物84-88; 烟酸铬37-42;
姜黄根提取物28-32; 盐酸小檗碱98-105;
绿咖啡豆提取物56-64。
进一步地,原料中的泡桐果提取物经下述步骤制备而成:将泡桐果原药材除去杂质,洗净、干燥、粉碎后加入10倍量体积浓度为1.5%的醋酸水溶液,浸泡1小时后煎煮0.5小时,药液滤过,滤液备用,在相同条件下将药渣重复提取1次,过滤,合并滤液,减压浓缩至小体积后喷雾干燥,即得到泡桐果提取物。
优选地,上述各原料的重量份为:
泡桐果提取物84; 烟酸铬37;
姜黄根提取物28; 盐酸小檗碱98;
绿咖啡豆提取物56。
优选地,上述各原料的重量份为:
泡桐果提取物85; 烟酸铬40;
姜黄根提取物30; 盐酸小檗碱100;
绿咖啡豆提取物60。
优选地,上述各原料的重量份为:
泡桐果提取物88; 烟酸铬42;
姜黄根提取物32; 盐酸小檗碱105;
绿咖啡豆提取物64。
进一步地,本发明治疗糖尿病的药物组合物可按照本领域的常规方法制成任何常规的口服药物剂型,优选胶囊剂、片剂或颗粒剂。
作为一种优选,本发明治疗糖尿病的药物组合物经下述方法制备而成,包括以下步骤:
(1)将泡桐果原药材除去杂质,洗净、干燥、粉碎后加入10倍量体积浓度为1.5%的醋酸水溶液,浸泡1小时后煎煮0.5小时,药液滤过,滤液备用,在相同条件下将药渣重复提取1次,过滤,合并滤液,减压浓缩至小体积后喷雾干燥,得到泡桐果提取物;
(2)将姜黄根洗净、干燥、粉碎后加入10倍量40%乙醇,浸泡2小时后回流提取1小时,药液滤过,滤液备用,在相同条件下将药渣重复提取1次,过滤,合并滤液,真空干燥,得到姜黄根提取物;
(3)将绿咖啡豆水漂洗、干燥、粉碎后加入30倍量沸水,浸泡10分钟后煎煮0.5小时,过滤,滤液真空干燥,得到绿咖啡豆提取物;
(4)将上述泡桐果提取物、姜黄根提取物、绿咖啡豆提取物和烟酸铬、盐酸小檗碱混合,在搅拌机中充分混匀,即得本药物组合物。
进一步地,本发明还涉及上述治疗糖尿病的药物组合物在制备用于治疗糖尿病的药物或保健食品中的应用。
经药理和毒理实验证实,在小鼠糖尿病模型中,本发明药物组合物的降血糖作用优于对照药二甲双胍,且服用安全性良好,在正常服用剂量20倍的测试剂量下,未出现任何毒性反应。此外,本发明药物组合物可制成多种口服剂型,便于携带和服用。
具体实施方式
下文结合具体实施例和对比例对本发明药物组合物的药效学及毒理学研究进行详细说明。
实施例1
一种治疗糖尿病的药物组合物,是由下述重量份的原料制成的:
泡桐果提取物85; 烟酸铬40;
姜黄根提取物30; 盐酸小檗碱100;
绿咖啡豆提取物60。
制备方法如下:
(1)将泡桐果原药材除去杂质,洗净、干燥、粉碎后加入10倍量体积浓度为1.5%的醋酸水溶液,浸泡1小时后煎煮0.5小时,药液滤过,滤液备用,在相同条件下将药渣重复提取1次,过滤,合并滤液,减压浓缩至小体积后喷雾干燥,得到泡桐果提取物;
(2)将姜黄根洗净、干燥、粉碎后加入10倍量40%乙醇,浸泡2小时后回流提取1小时,药液滤过,滤液备用,在相同条件下将药渣重复提取1次,过滤,合并滤液,真空干燥,得到姜黄根提取物;
(3)将绿咖啡豆水漂洗、干燥、粉碎后加入30倍量沸水,浸泡10分钟后煎煮0.5小时,过滤,滤液真空干燥,得到绿咖啡豆提取物;
(4)将上述泡桐果提取物、姜黄根提取物、绿咖啡豆提取物和烟酸铬、盐酸小檗碱混合,在搅拌机中充分混匀,即得本药物组合物。
实施例2
一种治疗糖尿病的药物组合物,是由下述重量份的原料制成的:
泡桐果提取物84; 烟酸铬37;
姜黄根提取物28; 盐酸小檗碱98;
绿咖啡豆提取物56。
制备方法同实施例1。
实施例3
一种治疗糖尿病的药物组合物,是由下述重量份的原料制成的:
泡桐果提取物88; 烟酸铬42;
姜黄根提取物32; 盐酸小檗碱105;
绿咖啡豆提取物64。
制备方法同实施例1。
对比例
一种治疗糖尿病的药物组合物,是由下述重量份的原料制成的:
烟酸铬40; 姜黄根提取物30;
盐酸小檗碱100; 绿咖啡豆提取物60。
制备方法如下:
(1)将姜黄根洗净、干燥、粉碎后加入10倍量40%乙醇,浸泡2小时后回流提取1小时,药液滤过,滤液备用,在相同条件下将药渣重复提取1次,过滤,合并滤液,真空干燥,得到姜黄根提取物;
(2)将绿咖啡豆水漂洗、干燥、粉碎后加入30倍量沸水,浸泡10分钟后煎煮0.5小时,过滤,滤液真空干燥,得到绿咖啡豆提取物;
(3)将上述姜黄根提取物、绿咖啡豆提取物和烟酸铬、盐酸小檗碱混合,在搅拌机中充分混匀,即得本药物组合物。
药效学实验
【实验材料】
受试药物:实施例1-3、对比例制得的药物组合物(以水分别配制成浓度为25.0mg/ml的混悬液)。
对照药物:盐酸二甲双胍片(研磨成粉末后以水配制成浓度为25.0mg/ml的混悬液)。
实验动物:雄性ICR小鼠,体重:18-22g。
【造模方法】
造模剂:链脲佐菌素(以0.1mol/L,pH=4.4枸橼酸缓冲液配制成浓度为13.5mg/ml的溶液)。
造模方法:随机选取100只小鼠,禁食12小时后,腹腔内注射链脲佐菌素(135mg/kg)建立糖尿病小鼠模型。于造模两周后从小鼠眼眶后静脉丛取血测定血糖浓度,血糖浓度高于正常组两倍者为糖尿病小鼠。
【实验分组】
从造模成功的小鼠中选择体重相近的60只,随机分为6组,即空白组(不用药)、对照药物组(二甲双胍)和受试药物组(即实施例1-3组和对比例组)。
【实验方法】
给药途径:口服灌胃给药。
给药方式与剂量
受试药物组:250mg/kg体重,每日早晚称量体重后,将受试药物混悬液分两次给予;
对照药物组:250mg/kg体重,每日早晚称量体重后,将二甲双胍混悬液分两次给予。
连续给药7日,第8日清晨空腹眼眶后静脉丛取血测血糖。
【实验结果】
观测指标:给药前后血糖值(取各组小鼠血糖平均值)。
测量记录时间:首次给药前和D8。
各组小鼠给药前后血糖值结果如表1所示:
表1各组小鼠给药前后血糖值
组别 | n | 给药前血糖(mmol/L) | 给药后血糖(mmol/L) |
空白组 | 10 | 14.33±4.51 | 16.90±5.27 |
二甲双胍组 | 10 | 13.19±4.02 | 7.14±2.56<sup>**</sup> |
实施例1组 | 10 | 13.76±3.89 | 6.21±2.44<sup>**</sup> |
实施例2组 | 10 | 14.62±4.40 | 5.79±2.06<sup>**</sup> |
实施例3组 | 10 | 14.13±4.25 | 5.93±1.75<sup>**</sup> |
对比例组 | 10 | 13.71±4.07 | 10.68±2.96<sup>*</sup> |
注:*与空白组比较P≤0.05;**与空白组比较P≤0.01。
从表1可以看出:与空白组相比,各实验组小鼠血糖值均有不同程度的降低,提示各组小鼠的糖尿病程度均有所减轻。其中,实施例1-3组血糖值降低程度较二甲双胍对照组更为明显,显示出了非常好的治疗糖尿病效果,而对比例组药物组合物的降血糖作用则要弱于二甲双胍对照组。
毒理实验
选取健康ICR小鼠20只(雌雄各半,体重18-22g),按照每日5000mg/kg体重的剂量(正常给药剂量的20倍)口服灌胃给予本发明药物组合物(实施例1),每日早晚称量体重后,将受试药物混悬液分两次给予,连续给药7日。
活体观测指标:实验期间密切观察小鼠的体重、饮食饮水、行为活动、精神状态、呼吸、分泌物、粪便、发病、死亡等情况,同时检查小鼠的皮肤、被毛、眼睛、耳朵、鼻、腹部、外生殖器、肛门、四肢、足有无异常。
解剖观测指标:实验结束后,解剖小鼠,观察小鼠心、肝、胰腺、脾、肺、肾、生殖腺等脏器的色泽、重量及形态是否正常。
经检测,连续给药7日后实验小鼠的各项活体观测指标和解剖观测指标均未见异常,从而证实本药物组合物即使在大剂量给药时也不会对实验动物造成毒性损伤,其使用安全性较高。
以上对本发明优选的具体实施方式和实施例作了详细说明,但是本发明并不限于上述实施方式和实施例,在本领域技术人员所具备的知识范围内,还可以在不脱离本发明构思的前提下作出各种变化。
Claims (7)
1.一种治疗糖尿病的药物组合物,其特征在于它是由下述重量份的原料制成的:
泡桐果提取物 84-88; 烟酸铬 37-42;
姜黄根提取物 28-32; 盐酸小檗碱 98-105;
绿咖啡豆提取物 56-64;
所述泡桐果提取物经下述步骤制备而成:将泡桐果原药材除去杂质,洗净、干燥、粉碎后加入10倍量体积浓度为1.5%的醋酸水溶液,浸泡1小时后煎煮0.5小时,药液滤过,滤液备用,在相同条件下将药渣重复提取1次,过滤,合并滤液,减压浓缩至小体积后喷雾干燥,即得到泡桐果提取物;
所述绿咖啡豆提取物经下述步骤制备而成:将绿咖啡豆水漂洗、干燥、粉碎后加入30倍量沸水,浸泡10分钟后煎煮0.5小时,过滤,滤液真空干燥,得到绿咖啡豆提取物。
2.如权利要求1所述的治疗糖尿病的药物组合物,其中各原料的重量份是:
泡桐果提取物 84; 烟酸铬 37;
姜黄根提取物 28; 盐酸小檗碱 98;
绿咖啡豆提取物 56。
3.如权利要求1所述的治疗糖尿病的药物组合物,其中各原料的重量份是:
泡桐果提取物 85; 烟酸铬 40;
姜黄根提取物 30; 盐酸小檗碱 100;
绿咖啡豆提取物 60。
4.如权利要求1所述的治疗糖尿病的药物组合物,其中各原料的重量份是:
泡桐果提取物 88; 烟酸铬 42;
姜黄根提取物 32; 盐酸小檗碱 105;
绿咖啡豆提取物 64。
5.如权利要求1-4任一项所述的治疗糖尿病的药物组合物,其特征在于所述药物组合物为胶囊剂、片剂或颗粒剂。
6.如权利要求1-4任一项所述的治疗糖尿病的药物组合物,其特征在于所述药物组合物经下述方法制备而成,包括以下步骤:
(1)将泡桐果原药材除去杂质,洗净、干燥、粉碎后加入10倍量体积浓度为1.5%的醋酸水溶液,浸泡1小时后煎煮0.5小时,药液滤过,滤液备用,在相同条件下将药渣重复提取1次,过滤,合并滤液,减压浓缩至小体积后喷雾干燥,得到泡桐果提取物;
(2)将姜黄根洗净、干燥、粉碎后加入10倍量40%乙醇,浸泡2小时后回流提取1小时,药液滤过,滤液备用,在相同条件下将药渣重复提取1次,过滤,合并滤液,真空干燥,得到姜黄根提取物;
(3)将绿咖啡豆水漂洗、干燥、粉碎后加入30倍量沸水,浸泡10分钟后煎煮0.5小时,过滤,滤液真空干燥,得到绿咖啡豆提取物;
(4)将上述泡桐果提取物、姜黄根提取物、绿咖啡豆提取物和烟酸铬、盐酸小檗碱混合,在搅拌机中充分混匀,即得本药物组合物。
7.如权利要求1-4任一项所述的治疗糖尿病的药物组合物在制备用于治疗糖尿病的药物或在制备用于辅助降血糖的保健食品中的应用。
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