CN110404029B - 一种具有降血糖功效的组合物及其制备方法和应用 - Google Patents
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Abstract
本发明涉及中药组合物技术领域，公开了一种具有降血糖功效的组合物及其制备方法和应用。本发明所述组合物包括黄皮果皮、玉米须、大叶冬青、高良姜和苦瓜五种原料药的提取物。本发明选择黄皮果皮、玉米须、大叶冬青、高良姜和苦瓜五种药食同源的原料药进行提取，经过水提醇沉和大孔树脂富集，获得了一种具有由于常规药物的降血糖功效的组合物，其能够辅助治疗，或通过病人较长时间食用，改善其血糖水平，制备成功能性食品还能满足糖尿病人群的营养和口感需求。
Description
技术领域
本发明涉及中药组合物技术领域，具体涉及一种具有降血糖功效的组合物及其制备方法和应用。
背景技术
随着社会的发展与科技的进步，人们生活水平不断提高，人们的饮食结构也随之发生改变，糖类、蛋白质和脂肪的摄入量不断增加，而运动量却相对减少，高血糖等代谢性问题呈现不断上升的趋势，这也加剧了糖尿病、动脉粥样硬化、冠心病、脂肪肝等疾病发病率的升高。
高血糖是由于人体胰岛素分泌缺陷或共生物作用受损，或两者兼有引起的。是继肿瘤、血管病变之后，严重威胁人类健康的疾病。高血糖人群分为两个部分，一部分是有高血糖前期症状，但尚未被确定为糖尿病的人群，另一部分是糖尿病人群。高血糖作为一种症状并不能说明一定是糖尿病，高血糖指的是血糖高于正常值，但是没有达到糖尿病的诊断标准，人体正常血糖值为：空腹血糖<6.1，餐后两小时血糖<7.8，而糖尿病的诊断标准为：空腹血糖大于或等于7，餐后两小时大于或等于11.1，如果血糖值在正常和糖尿病之间的就是高血糖，也叫糖尿病前期。高血糖还有机会将血糖纠正，以后不用药物来控制血糖，对生活没有大的影响。而糖尿病确诊后，几乎是不可逆的。
据2016年世界卫生组织统计，我国糖尿病人已经超过1.1亿人，到2040年要超过1.5亿人。而尚未确定为糖尿病的高血糖人群约2亿多人，其中有0.4亿的人群要成为糖尿病病人。所以，降低高血糖人员的增加，是刻不容缓的大事，而且降低血糖也能改善二型糖尿病病人高血糖状况，辅助二型糖尿病的治疗。
目前糖尿病人的饮食需要进行严格的控制，不宜吃各种糖、固体饮料、蜜饯、水果罐头、饼干、甜面包及糕点等，而采用日常食物特别是“药食同源”原料的配伍，研制适合糖尿病以及高血糖人群食用且具有降血糖作用的食品，一方面能够辅助治疗，或通过病人较长时间食用，改善其血糖和水平，还能满足糖尿病人群的营养和口感需求。
发明内容
有鉴于此，本发明的目的在于提供一种具有降血糖功效的组合物，使其具备显著的降血糖功效；
本发明的另一个目的在于提供一种具有降血糖功效的组合物，使其具备显著的α-葡萄糖苷酶抑制活性。
本发明的另一个目的在于提供上述组合物的制备方法以及其在降血糖功能性食品中的应用。
为了实现上述目的，本发明提供如下技术方案：
一种具有降血糖功效的组合物，包括黄皮果皮、玉米须、大叶冬青(叶子)、高良姜和苦瓜五种原料药的提取物。
作为优选，各原料药重量份如下：
黄皮果皮50-100份、玉米须20-50份、大叶冬青20-50份、高良姜10-40份和苦瓜20-50份。
在本发明具体实施方式中，各原料药重量份可选择如下之一：
(1)黄皮果皮50份、玉米须20份、大叶冬青20份、高良姜10份和苦瓜20份。
(2)黄皮果皮100份、玉米须50份、大叶冬青50份、高良姜40份和苦瓜50份。
(3)黄皮果皮70份、玉米须40份、大叶冬青30份、高良姜30份和苦瓜50份。
在本发明具体实施方式中，上述五种原料药的提取物为经过水提醇沉后的提取物，更优选地的是经过水提醇沉以及大孔树脂富集和洗脱后的提取物。
对2型糖尿病大鼠的空腹血糖试验中，本发明所述组合物能够显著降低大鼠的空腹血糖，效果优于常规药物二甲双胍以及其他中药复方的对照组合物；同时，在检测α-葡萄糖苷酶抑制活性试验中，本发明组合物具备较高的α-葡萄糖苷酶抑制活性，效果明显优于常规药物阿卡波糖以及其他中药复方的对照组合物；上述两方面的试验表明本发明组合物能够有效降低空腹血糖和餐后血糖，具备明显的降血糖功效。
基于优异的试验结果，本发明提出了所述组合物在制备具有降血糖功效的食品中的应用；其中，所述食品包括但不限于固体饮料、饼干或糖果。
同时，本发明还提供所述组合物的制备方法，包括：
步骤1、将黄皮果皮、玉米须、大叶冬青、高良姜和苦瓜进行水提，浓缩，获得浓缩液；
步骤2、所述浓缩液加入乙醇进行醇沉，所得滤液浓缩获得浸膏；
步骤3、所述浸膏经大孔树脂富集和洗脱，获得所述组合物。
本发明具体实施方式中，步骤1为：
五种原料药经过粉碎后称重，加入3-10倍重量的水进行提取，提取温度为100-120℃，每次提取60-120min，提取3次；提取液混合后过滤，减压浓缩滤液至料液比1:2，得浓缩液。
在本发明具体实施方式中，步骤2为：
所述浓缩液按照1:1的比例，搅拌并加入乙醇，析出沉淀，过滤除去沉淀，滤液减压浓缩除去溶剂，得浸膏。
在本发明具体实施方式中，步骤3为：
所述浸膏经过大孔树脂富集，先用100％水洗脱，再用体积比3:7乙醇-水溶液进行洗脱，然后用体积比7:3乙醇-水溶液进行洗脱，合并后两次洗脱液，减压浓缩除去溶剂，再经过喷雾干燥，得到所述组合物。
由以上技术方案可知，本发明选择黄皮果皮、玉米须、大叶冬青、高良姜和苦瓜五种药食同源的原料药进行提取，经过水提醇沉和大孔树脂富集，获得了一种具有由于常规药物的降血糖功效的组合物，其能够辅助治疗，或通过病人较长时间食用，改善其血糖水平，制备成功能性食品还能满足糖尿病人群的营养和口感需求。
具体实施方式
本发明公开了一种具有降血糖功效的组合物及其制备方法和应用，本领域技术人员可以借鉴本文内容，适当改进工艺参数实现。特别需要指出的是，所有类似的替换和改动对本领域技术人员来说是显而易见的，它们都被视为包括在本发明。本发明所述组合物及其制备方法和应用已经通过较佳实施例进行了描述，相关人员明显能在不脱离本发明内容、精神和范围内对本文所述组合物及其制备方法和应用进行改动或适当变更与组合，来实现和应用本发明技术。
在本发明具体对比试验中，各组除应有的区别外，其余材料等试验环境均保持一致。
以下就本发明所提供的一种具有降血糖功效的组合物及其制备方法和应用做进一步说明。
实施例1：本发明所述组合物
1、原料药重量份
(1)黄皮果皮50份、玉米须20份、大叶冬青20份、高良姜10份和苦瓜20份。
(2)黄皮果皮100份、玉米须50份、大叶冬青50份、高良姜40份和苦瓜50份。
(3)黄皮果皮70份、玉米须40份、大叶冬青30份、高良姜30份和苦瓜50份。
2、水提醇沉法
五种原料药经过粉碎后称重，加入3-10倍重量的水进行提取，提取温度为100-120℃，每次提取60-120min，提取3次；提取液混合后过滤，减压浓缩滤液至料液比1:2，得浓缩液；
所述浓缩液按照1:1的比例，搅拌并加入乙醇，析出沉淀，过滤除去沉淀，滤液减压浓缩除去溶剂，得浸膏；
所述浸膏经过101大孔树脂富集，先用100％水洗脱，再用体积比3:7乙醇-水溶液进行洗脱，然后用体积比7:3乙醇-水溶液进行洗脱，合并后两次洗脱液，减压浓缩除去溶剂，再经过喷雾干燥，得到所述组合物。
实施例2：对2型糖尿病大鼠的影响
实验动物：SPF级健康雄性SD大鼠，6～8周龄，体质量(140±20)g。
试验药物:本发明实施例1组合物(配方1)；
对比组：常规药物盐酸二甲双胍片；对比例1：玉米须、大叶冬青、高良姜和苦瓜；对比例2：黄皮果皮、玉米须、大叶冬青、高良姜、苦瓜和薏苡仁；对比例3：黄皮果皮、玉米须、大叶冬青、薏苡仁和苦瓜；对比例提取方法同
实施例1；
造模：大鼠喂养高糖高脂饲料4周后，对大鼠注射STZ制备2型糖尿病模型：造模前大鼠禁食不禁水12h，将STZ溶解于柠檬酸-柠檬酸钠溶液中，对大鼠进行腹腔注射，大鼠STZ的注射剂量为50mg/kg。1周后测定大鼠空腹血糖，血糖值≥9mmol/L作为模型大鼠。
分组给药：将糖尿病大鼠随机分为5组：模型组(蒸馏水，等体积)，二甲双胍组(盐酸二甲双胍片，0.1g/kg)，本发明实施例1组合物高、中、低剂量组(10g/kg，5g/kg，1g/kg)，对比例1-3高剂量组(10g/kg)，每组8只；另取8只正常大鼠作为空白组(蒸馏水，等体积)。连续灌胃给药28d，1次/d，给药期间空白组大鼠饲喂维持饲料，其余各组均饲喂高糖高脂饲料。所有大鼠禁食不禁水8h，剪尾尖取血，血糖仪测定空腹血糖值。结果如表1所示。
表1本发明所述固体饮料对2型糖尿病大鼠FBG的影响(n＝8，mmol/L)
| 组别 | 给药前 | 给药后 |
| 本发明组合物高剂量组 | 23.60±4.21* | 6.65±2.23<sup>△▲■</sup> |
| 本发明组合物中剂量组 | 24.50±3.88* | 7.55±2.62<sup>△▲■</sup> |
| 本发明组合物低剂量组 | 23.45±4.11* | 8.24±2.80<sup>△▲■</sup> |
| 二甲双胍组 | 23.65±3.25* | 11.74±2.65<sup>△▲</sup> |
| 对比例1高剂量组 | 24.27±3.53* | 15.37±2.37<sup>△▲</sup> |
| 对比例2高剂量组 | 24.18±3.34 | 13.74±2.24<sup>△▲</sup> |
| 对比例3高剂量组 | 24.85±3.75* | 16.23±2.75<sup>△▲</sup> |
| 模型组 | 25.45±3.45* | 23.50±3.21* |
| 空白组 | 5.25±0.33 | 5.58±0.27 |
注：与空白组同期比较，*P<0.01；与模型组同期比较，△P<0.01；与本组治疗前比较，▲P<0.01；与二甲双胍组同期比较，■P<0.01；。
本发明所述固体饮料高、中、低剂量组(10g/kg，5g/kg，1g/kg)及阳性药二甲双胍组和三个对比例组，均对糖尿病大鼠具有较好的降血糖作用(P<0.01)；其中，本发明所述组合物高、中、低剂量组相比二甲双胍药物具有更佳明显的效果；而其他三个对比例组效果低于常规药物二甲双胍。
同时，以本发明实施例1中其余两个配方为试验对象，试验结果与上述结果基本一致。
实施例3：体外α-葡萄糖苷酶抑制活性试验
试验药物:本发明实施例5固体饮料；
对比组：常规药物阿卡波糖；对比例1-3同实施例2；
试剂：阿卡波糖、α-葡萄糖苷酶、对硝基苯-α-葡萄糖苷(pNPG)、α-葡萄糖苷酶、磷酸氢钾、磷酸二氢钾、无水乙醇、二甲基亚砜和碳酸钠。
方法：：0.1mmol/L的磷酸钾缓冲液(pH值6.8)0.5mL，再加入10mg/Lα-葡萄糖苷酶100μL，0.5mL样品溶液，混匀，37℃恒温15min后，加入2.5mmol/L pNPG 0.5mL，混匀后37℃恒温15min，最后加入1mL 0.2mol/L的Na2CO3溶液终止反应，于405nm波长下测OD值，重复3次，取平均值。实验重复3次。以阿卡波糖为阳性对照，分别检测不同质量浓度(0.05g/mL、0.1g/mL和0.5g/mL)的本发明实施例1组合物对α-葡萄糖苷酶的抑制活性，按(公式1)计算出抑制率，并计算其IC50值。结果如下表2所示。
酶活性抑制率＝[A空白-(A样品-A背景)]/A空白×100％ (公式1)
A空白：不加待测样品，只加入待测样品的溶剂，进行反应后的吸光值
A样品：加入待测样品反应后的吸光值
A背景：只加待测样品反应后的吸光值
表2本发明固体饮料的体外α-葡萄糖苷酶抑制活性试验效果
本发明组合物有明显的α-葡萄糖苷酶抑制活性作用，抑制效果均显著好于阳性对照组阿卡波糖。同时，以本发明实施例1中其余两个配方为试验对象，试验结果与上述结果基本一致。
以上所述仅是本发明的优选实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本发明原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也应视为本发明的保护范围。
Claims (6)
1.一种具有降血糖功效的组合物，其特征在于，由黄皮果皮、玉米须、大叶冬青、高良姜和苦瓜五种原料药的提取物组成，各原料药重量份如下：
黄皮果皮50-100份、玉米须20-50份、大叶冬青20-50份、高良姜10-40份和苦瓜20-50份；
并经由以下制备方法制备获得：
步骤1、将黄皮果皮、玉米须、大叶冬青、高良姜和苦瓜进行水提，浓缩，获得浓缩液；
步骤2、所述浓缩液加入乙醇进行醇沉，所得滤液浓缩获得浸膏；
步骤3、所述浸膏经过大孔树脂富集，先用100％水洗脱，再用体积比3:7乙醇-水溶液进行洗脱，然后用体积比7:3乙醇-水溶液进行洗脱，合并后两次洗脱液，减压浓缩除去溶剂，再经过喷雾干燥，得到所述组合物。
2.权利要求1所述组合物在制备具有降血糖功效的食品中的应用。
3.根据权利要求2所述应用，其特征在于，所述食品为固体饮料、饼干或糖果。
4.权利要求1所述组合物的制备方法，其特征在于，包括：
步骤1、将黄皮果皮、玉米须、大叶冬青、高良姜和苦瓜进行水提，浓缩，获得浓缩液；
步骤2、所述浓缩液加入乙醇进行醇沉，所得滤液浓缩获得浸膏；
步骤3、所述浸膏经过大孔树脂富集，先用100％水洗脱，再用体积比3:7乙醇-水溶液进行洗脱，然后用体积比7:3乙醇-水溶液进行洗脱，合并后两次洗脱液，减压浓缩除去溶剂，再经过喷雾干燥，得到所述组合物。
5.根据权利要求4所述制备方法，其特征在于，步骤1为：
五种原料药经过粉碎后称重，加入3-10倍重量的水进行提取，提取温度为100-120℃，每次提取60-120min，提取3次；提取液混合后过滤，减压浓缩滤液至料液比1:2，得浓缩液。
6.根据权利要求4所述制备方法，其特征在于，步骤2为：
所述浓缩液按照1:1的比例，搅拌并加入乙醇，析出沉淀，过滤除去沉淀，滤液减压浓缩除去溶剂，得浸膏。
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