CN109157616A - 用于逆转糖尿病的药食用组合物及配制、应用 - Google Patents
用于逆转糖尿病的药食用组合物及配制、应用 Download PDFInfo
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Abstract
本发明涉及一种用于逆转糖尿病的药食用组合物，还涉及到该药食用组合物的配制及其应用，其原料食材按质量计，包括人参3‑10g，葫芦巴3‑10g，玉米须1‑5g，肉桂2‑6g，桑叶1‑5g，梨果仙人掌1‑5g，丁香1‑5g，小茴香1‑5g，朝鲜蓟1‑5g，苦瓜1‑5g。本发明的有益效果是：1)本发明配合低脂纯植物性饮食，经过多次临床试验，能帮助二型糖尿病病人，在10‑15天之内，迅速摆脱胰岛素和各种降糖药物，餐前餐后血糖并保持正常范围；2)由人参等十种食物的粉剂配制而成，各食物组分协同发挥作用，既保证效果，又控制了成本；3)具有降低血糖，改善胰岛素抵抗，促进胰岛素分泌的功效，有效率达95％。
Description
技术领域
本发明涉及一种用于逆转糖尿病的药食用组合物，还涉及到该药食用组合物的配制及其应用。
背景技术
目前的医用降糖药，均能有效降低血糖，但是有不同的药物副作用。
例如：二甲双胍，能减少肝糖生成，减少胃肠道对糖的吸收，增加外周葡萄糖摄取和利用[1],但是易产生胃肠道反应，令VB12缺乏，导致巨幼细胞贫血[2]。
磺胺类药物和格列奈类药物，可以刺激胰腺尚有功能的β细胞工作，刺激胰岛素第一时相分泌，但是两类药物常见不良反应是容易导致低血糖，或体重增加[3]。
艾可拓和文迪雅(格列酮类)可以减少肝脏和外周的胰岛素抵抗，增加胰岛素依赖的血糖应用，减少肝糖输出，但是，常见不良反应是增加皮下脂肪，可能导致或加重充血性心功能衰竭[4][5]。
胰岛素(速效，短效，中效，长效)机制是促进肌肉和脂肪对葡萄糖的摄取，减少肝糖输出，抑制脂肪分解，抑制蛋白质分解，增加蛋白质合成。但是，常见不良反应是低血糖及体重增加。
可以看出，虽然现有的医用降糖药能够对血糖的降低产生一定的效用，但是或多或少对人体产生一定的副作用。
发明内容
本发明所要解决的技术问题是针对上述现有技术而提供一种用于逆转糖尿病的药食用组合物，其可以改善胰岛素抵抗，促进胰岛素分泌，在摆脱化学药物和针剂的情况下，迅速降血糖，减缓和控制并发症，且令糖化血红蛋白逐步恢复到正常值，效果显著，且方便实效。
本发明解决上述技术问题所采用的技术方案是：用于逆转糖尿病的药食用组合物，其原料食材按质量计，包括人参3-10g，葫芦巴3-10g，玉米须1-5g，肉桂2-6g，桑叶1-5g，梨果仙人掌1-5g，丁香1-5g，小茴香1-5g，朝鲜蓟1-5g，苦瓜1-5g。
上述原料按质量计，优选为：包括人参5g，葫芦巴5g，玉米须3g，肉桂3g，桑叶2g，梨果仙人掌2g，丁香2g，小茴香1g，朝鲜蓟1g，苦瓜1g。
上述用于逆转糖尿病的药食用组合物的制作方法是，按质量称取各组分，将各食材研成粉末，放置容器中，混合均匀即可。
本发明所得的用于逆转糖尿病的药食用组合物可以作为逆转糖尿病的保健食品的应用。
本发明所述的药食组合物的剂型可以为冲剂、片剂、颗粒、口服液、丸剂或滴丸等。
本发明所述的药食组合物的剂型可以作为制备糖尿病药物的应用。
在本发明中，各原料的功能如下：
1、人参：人参中的人参皂苷可改善胰岛素抵抗；保护胰岛细胞，改善糖耐，调节肠道菌群；
2、葫芦巴：富含纤维，可增加饱腹感提高糖耐量；含有的4-羟基异亮氨酸可以促进胰岛素释放；
3、玉米须：利尿消肿，清肝利胆的功效；其中皂甙、黄酮类物质、铬，有降血糖的功效；
4、肉桂：可以增强胰岛素信号传导，增加糖原合成酶活性；
5、桑叶：桑叶中含有丰富的糖苷酶抑制剂1-脱氧野尻霉素(DNJ)和桑叶多糖。桑叶DNJ通过对糖类分解酶活性的抑制，从而抑制小肠对双糖的吸收，降低餐后血糖峰值；
6、梨果仙人掌:能够增加对胰岛素的敏感度；
7、丁香：改善胰岛素功能；
8、小茴香：平衡血糖，改善胰岛素；
9、朝鲜蓟：所含有的类黄酮，苦味素有辅助洋蓟酸保护肝脏和促进肝脏排毒的功能；
10、苦瓜：可以通过活化AMP激酶改善胰岛素抵抗；
其中，作为本发明的核心组分是人参，葫芦巴，玉米须，肉桂。取自人参根须中的人参皂苷Rb1对嘌呤代谢、嘧啶代谢、氨基酸代谢和胆固醇代谢具有调节作用，而人参皂苷Rg3，对核酸代谢、能量代谢和肠内菌群代谢具有调节作用，两者均可改善胰岛素抵抗。肉桂粉能降低18％-29％的空腹血糖值，不仅降血糖，还能降低血胆固醇。葫芦巴可以改善小肠内糖类的水解，延迟葡萄糖和其他单糖，双糖在消化道内的吸收，改善餐后血糖快速升高。玉米须含大量硝酸钾、维生素K、谷固醇、豆固醇和一种挥发性生物碱，是强利尿剂，可以帮助排除水分滞留以及减少体重。四个核心组分相互配合，协同作用于不同时效，且共同特点是不易引起低血糖。
与现有技术相比，本发明的有益效果是：
1)本发明配合低脂纯植物性饮食，经过多次临床试验，能帮助二型糖尿病病人，在10-15天之内，迅速摆脱胰岛素和各种降糖药物，餐前餐后血糖并保持正常范围；
2)本发明配制所需的食物不多，是经过临床试验所得配方，由人参等十种食物的粉剂配制而成，各食物组分协同发挥作用，既保证效果，又控制了成本；
3)本发明所述这种药食两用的食物组合通过对100多例患者的调理与观察，具有降低血糖，改善胰岛素抵抗，促进胰岛素分泌的功效，有效率达95％。
具体实施方式
下面通过实施例对本发明做进一步详细的说明。
实施例1：
按质量称取各组分，包括人参10g，葫芦巴30g，玉米须10g，肉桂6g，桑叶6g，梨果仙人掌6g，丁香6g，小茴香6g，朝鲜蓟10g，苦瓜5g，将各食材研成粉末，放置容器中，混合均匀即可。
按常规工艺制作成丸剂。
应用实验例：将上述制得的用于逆转糖尿病的药食用组合物进行实验验证，考察其效果。
1动物实验
1.1动物选择
选用健康成年动物，常用小鼠(25±2g)或大鼠(180±20g)，单一性别，大鼠每组8-12
只、小鼠每组10-15只。
1.2材料
1.2.1试剂
四氧嘧啶(或链脲霉素)小鼠35-50mg/kg.bw.iv(100-160mg/kg.bw.ip)、大鼠
50-80mg/kg.bw.iv(200-250mg/kg.bw.ip)用新鲜配制。
血溏测定试纸或试剂盒。
1.2.2仪器
血糖仪、全自动生化仪、721-B型分光光度计。
1.3剂量分组及受试样品给予时间
设1个溶剂对照组和3个受试样品剂量组，分别是20g，25g，30g(根据人体每日每公
斤体重推荐摄入量)，小鼠扩大10倍作为其中一个剂量组(大鼠扩大5倍)，根据受试样
品的具体情况另设两个剂量组。受试样品给予时间原则上不少于30天，也可根据实验需
要自行设定期限。
1.4实验方法
1.4.1降低空腹血糖实验
1.4.1.1高血糖模型动物
1.4.1.1.1原理
四氧嘧啶(或链脲霉素)是一种β细胞毒剂，可选择性地损伤多种动物的胰岛β细胞，造成胰岛素分泌低下引起实验性糖尿病。
1.4.1.1.2造型
动物禁食24小时后，给予四氧嘧啶造型，5-7天后禁食3-5小时，测血糖，血糖值10-25mmol/L为高血糖模型成功动物。
1.4.1.1.3操作步骤
选高血糖模型动物按禁食3-5小时的血糖水平分组，随机选1个模型对照组和3个剂量组，分别是20g，25g，30g(根据人体每日每公斤体重推荐摄入量)。剂量组给予不同浓度受试样品，模型对照组给予溶剂，连续30天，测空腹血糖值(禁食同实验前)，比较各组动物血糖值及血糖降低的绝对值(即实验前后血糖的差值)。
1.4.1.2正常动物
选健康成年动物按禁食3-5小时的血糖水平分组，随机选1个对照组和1个受试样品组(高剂量)。余操作同1.4.1.1.3。
1.4.2糖耐量实验
高血糖模型动物禁食3-5小时，剂量组给予不同浓度受试样品，模型对照组给予同体积溶剂，15-20分钟后经口给予葡萄糖2.0g/kg或医用淀粉3-52.0g/kg，测定给葡萄糖后0、0.5、2小时的血糖值或人医用淀粉后0、0.5、2小时的血糖值，观察模型对照组与受试样品组给葡萄糖或医用淀粉后各时间点血糖曲线下面积的变化。
血糖曲线下面积＝1/2×(0小时血糖值+0.5小时血糖值)×0.5+1/2×(2小时血糖值+0.5小时血糖值)×1.5＝0.25×(0小时血糖值+4×0.5小时血糖值+3×2小时血糖值).
1.5数据处理及结果判定
一般采用方差分析，但需按方差分析的程序先进行方差齐性检验，方差齐，计算F值，F值降空腹血糖实验：受试样品剂量组与对照组比较，空腹血糖实测值降低有统计学意义，可判定该受试样品降空腹血糖实验结果阳性。
经测试，本发明采用的三个剂量组降空腹血糖实验结果均为阳性。
糖耐量实验：受试样品剂量组与对照组比较，在给葡萄糖或医用淀粉后、0.0、0.5、2.0小时血糖曲线下面积降低有统计学意义，可判定该受试样品糖耐量实验结果阳性。
经测试，本发明采用的三个剂量组糖耐量实验结果均为阳性。
1.6注意事项
1.6.1为了使实验动物糖代谢功能状态尽量保持一致，也为了准确地按体重计算受试样品的用量，实验前动物应严格禁食(不禁水)，实验前后禁食条件应一致，鼠类在禁食的同时应更换衬垫物。
1.6.2血糖测定用试纸或试剂盒，按说明书操作；若自行配制试剂，按[附1]操作。
1.6.3如用血清样品进行测定，应于取血后30分钟内分离血清，分离后血清的含糖量在6小时内不变。用血清制备的无蛋白血滤液可保存48小时以上。
1.6.4高浓度的还原性物质如Vit C亦能与色素原竞争游离氧，干扰反应，使结果偏低。血红蛋白能使过氧化氢过早分解，亦干扰反应，致使测得血糖值偏低。故对已溶血的全血或血清必须制备无蛋白滤液后，再进行测定。
[附1]血糖值测定方法
1原理
葡萄糖氧化酶是一种需氧脱氢酶，能催化葡萄糖生成葡萄糖酸和过氧化氢，后者在过氧化物酶作用下放出氧，使4-氨基安替比林与酚氧化缩合，生成红色醌类化合物，可在波长505nm比色测定。
2试剂配制
磷酸盐缓冲液(0.2mol/L,pH7.0)
0.2mol/L Na2HPO4 61ml，0.2mol/L KH2HPO4 39ml混合即可。
酶试剂
葡萄糖氧化酶400u，过氧化物酶0.6mg,4-氨基安替比林10mg，叠氮钠100mg加磷酸盐缓冲液至100ml，PH调至7。冰箱存放至少可稳定2个月。
酚试剂
酚100mg溶于100ml蒸馏水中。
酶混合试剂
取等量酶试剂和酚试剂混合。在冰箱中可存放1个月。
葡萄糖标准液
储存液：无水D-葡萄糖(A.R.)在烤箱中80℃烤4小时，冷却后，存放于干燥器中至恒重。精确称取2g以0.25％苯甲酸溶液溶解并移入100ml容量瓶中，再用苯甲酸溶液稀释至100ml。
应用液：在100ml容量瓶中准确加入储存液5ml，再用0.25％苯甲酸溶液稀释至100ml，即1mg/mL应用液。
蛋白沉淀剂
溶解磷酸氢二钠10g、钨酸钠10g、氯化钠9g于800ml蒸馏水中，加入1mol/L盐酸125ml，并用蒸馏水稀释至1000ml。
3操作步骤
取蛋白沉淀剂1ml加入血浆(血清)50ul混匀。室温放置7分钟后，离心，取上清液(无蛋白血滤液)测定。葡萄糖标准应用液亦进行同样处理。
| 测定管 | 标准管 | 空白管 | |
| 无蛋白血滤液mL | 0.5 | - | - |
| 处理后的葡萄糖标准液mL | - | 0.5 | - |
| 蛋白沉淀液mL | 0.5 | ||
| 酶混合试剂mL | 4 | 4 | 4 |
混匀后，37℃水浴保温15分钟，用空白管调零点，在波长505nm处比色。
4结果计算
2人体试食试验
2.1试验设计
试验采用随机分组，组间和自身两种对照设计。
2.2受试产品
受试产品必须是具有定型包装、标明服用方法服用量的定型产品；安慰剂除功效成分外，在剂型、口感、外观和包装上与受试产品保持一致。
2.3受试者选择
2.3.1纳入标准
选择经饮食控制或口服降糖药治疗后病情较稳定，不需要更换药物品种及剂量，仅服用维持量的成年II型糖尿病病人，空腹血糖≥7.8mmol/L(140mg/dl)或餐后2h血糖≥11.1mmol/L(200mg/dl)；也可选择7.8mmol/L≥空腹血糖≥6.7mmol/L(120mg/dl)或11.1mmol/L≥餐后2h血糖≥7.8mmol/L的高血糖人群。
2.3.2排除标准
2.3.2.1I型糖尿病病人。
2.3.2.2年龄在18岁以下或65岁以上，妊娠或哺乳期妇女，对受试样品过敏者。
2.3.2.3有心、肝、肾等主要脏器并发症，或全并有其它严重疾病，精神病患者，服用糖皮质激素或其它影响血糖药物者。
2.3.2.4不合作者(指不能配合饮食控制而影响观察结果者)。
2.3.2.5近3个月内有糖尿病酮症、酸中毒以及感染者。
2.3.2.6凡不符合纳入标准，未按规定服用受试样品，或资料不全影响观察结果者。
2.4受试者分组
按受试者的血糖水平随机分为试食组(3个受试样品剂量组)和对照组，尽可能考虑影响结果的主要因素如病程、服药种类(黄脲类、双胍类)等，进行均衡性检验，以保证组间的可比性。每组受度者不少于50例。、
2.5试验方法
试验前对每一位受试者按性别、年龄、不同劳动强度、理想体重参照原来生活习惯规定相应的饮食，试食期间坚持饮食控制，治疗糖尿病的药物种类和剂量不变。试食组在服药的基础上，按推荐服用方法服用量每晶是食受试样品，对照组在服药的基础上，可不进行任何处理(或服用安慰剂)。连续观察时间不少于30天，必要时可以适当延长。
2.6观察指标
各项指标于实验开始及结束各检测一次，必要时实验中期血糖指标可加测一次。
2.6.1安全性指标
2.6.1.1一般状况体征包括精神、睡眠、饮食、大小便、血压等
2.6.1.2血、尿、便常规检查
2.6.1.3肝、肾功能检查
2.6.1.4胸透、心电图、腹部B超检查(仅试验前检查一次)
2.6.2功效指标
2.6.2.1症状观察
详细询问病史，了解患者饮食情况，用药情况，活动量，观察口渴多饮、多食易饥、倦怠乏力、多尿等主要临床症状，按症状轻重积分，于试食前后统计积分值，并就其主要症状改善(改善1分为有效)，观察临床症状改善率。
临床症状积分表
2.6.2.2空腹血糖
观察试食前后空腹血糖值及血糖下降的百分率。
2.6.2.3餐后2h血糖
观察试食前后食用100g精粉馒头后2小时血糖值及血糖下降的百分率。
2.6.3.4尿糖
用空腹晨尿定性，按—、±、+、++、+++、++++分别积0、0、5、1、2、3、4分，于试食前后统计积分值。
2.6.2.5血脂
观察试食前后血清总胆固醇、血清甘油三酯、高密度脂蛋白胆固醇水平。
2.7数据处理和结果判定
凡自身对照资料可以采用配对t检验，两组均数比较采用成组t检验，后者需进行方差齐性检验，对非正态分布或方差不齐的数据进行适当的变量转换，待满足正态方差齐后，用转换的数据进行t检验；若转换数据仍不能满足正态或方差齐的要求，改用t’检验或秩和检验；方差剂但变异系数太大(如CV>50％)的资料应用秩和检验。
结果判定
空腹血糖结果判定：①空腹血糖试验前后自身比较，差异有显著性，且试验后平均血糖下降≥10％，②试验后试食组血糖值或血糖下降百分率与对照组比较，差异有显著性。满足上述两个条件，可判定该受试样品空腹血糖指标结果阳性。经测试，三组(20g，25g，30g日用量)，空腹血糖指标结果均为阳性。
餐后2h血糖结果判定：①餐后2h血糖试验前后自身比较，差异有显著性，且试验后平均血糖下降≥10％，②试验后试食组血糖值或血糖下降百分率与对照组比较，差异有显著性。满足上述两个条件，可判定该受试样品餐后2h血糖指标结果阳性。经测试，三组(20g，25g，30g日用量)，空腹血糖指标结果均为阳性。
实施例2
按质量称取各组分，包括人参5g，葫芦巴5g，玉米须3g，肉桂3g，桑叶2g，梨果仙人掌2g，丁香2g，小茴香1g，朝鲜蓟1g，苦瓜1g，将各食材研成粉末，放置容器中，混合均匀即可。
按常规工艺制作成片剂。
实施例3
按质量称取各组分，包括人参5g，葫芦巴5g，玉米须3g，肉桂3g，桑叶2g，梨果仙人掌2g，丁香2g，小茴香1g，朝鲜蓟1g，苦瓜1g，将各食材研成粉末，放置容器中，混合均匀即可。
按常规工艺制作成丸剂。
实际应用案例
应用案例1：叶先生，年龄47岁，二型糖尿病，四年病史，一直没有吃药。曾用阿特金斯疗法+每天爬山8-12公里控制血糖，初期效果明显，两年之后，血糖全线崩溃，另外导致高血压，高尿酸血症和关节滑膜炎。调理前检测：空腹血糖14.2，餐后血糖13.8，血压144/116，体重82.1kg。
采用本发明实施例的丸剂(包括人参5g，葫芦巴5g，玉米须3g，肉桂3g，桑叶2g，梨果仙人掌2g，丁香2g，小茴香1g，朝鲜蓟1g，苦瓜1g)，配合低脂纯素调理了六天，第七天清晨到苏州大学附属第二医院(三甲)检测，叶先生的空腹血糖值：7.23mmol/L，餐后血糖值：7.18mmol/L，血压122/90，体重79.1kg。
应用案例2：刘先生，2013年，天津市医科大学总院确诊为二型糖尿病。平时每天注射20个单位胰岛素，但是血糖还是在12-13mmol/L的范围波动。2017年10月，刘先生来武汉调理。调理前检测时发现，空腹血糖13.3，糖化血红蛋白9.12，血压135/95，体重85.5kg，BMI＝31。用本发明实施例(包括人参5g，葫芦巴5g，玉米须3g，肉桂3g，桑叶2g，梨果仙人掌2g，丁香2g，小茴香1g，朝鲜蓟1g，苦瓜1g)+低脂纯素调理的第一天，胰岛素注射剂量即减为8个单位，第二天，停止注射胰岛素，调理第9天时，发现：在完全停止使用胰岛素的情况下，空腹血糖6.0,餐后6.2，糖化降为7.91，体重减轻4.5kg，BMI＝29.4。共9天的时间，空腹及餐后由来时的12-13降为正常，糖化由9.12降为7.91。
应用案例3：2008年4月，东女士在天津代谢病医院确诊为二型糖尿病。虽然每天口服六种降糖药，血糖控制还是不理想。餐前在4-7之间波动，餐后在7-12之间波动。2013年，东女士又因胆结石，做了胆囊摘除术。调理之前检测时发现，东女士BMI＝26.7，糖化6.29，B超显示有脂肪肝。采用本发明实施例1(包括人参5g，葫芦巴5g，玉米须3g，肉桂3g，桑叶2g，梨果仙人掌2g，丁香2g，小茴香1g，朝鲜蓟1g，苦瓜1g，)+低脂纯素调理第一天，即停止所有药物，全天血糖谱为：4.4-5.3-5.0-6.5-5.8-6.0-7.7，东女士四个月后去天津医科大学代谢病医院检测，糖化降低为6.1，并且转氨酶，血脂，尿酸等其他指标全部正常。
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Claims (6)
1.用于逆转糖尿病的药食用组合物，其原料食材按质量计，包括人参3-10g，葫芦巴3-10g，玉米须1-5g，肉桂2-6g，桑叶1-5g，梨果仙人掌1-5g，丁香1-5g，小茴香1-5g，朝鲜蓟1-5g，苦瓜1-5g。
2.根据权利要求1所述的用于逆转糖尿病的药食用组合物，其特征在于所述的原料按质量计，包括人参5g，葫芦巴5g，玉米须3g，肉桂3g，桑叶2g，梨果仙人掌2g，丁香2g，小茴香1g，朝鲜蓟1g，苦瓜1g。
3.根据权利要求1所述的用于逆转糖尿病的药食用组合物，其特征在于所述的药食用组合物的剂型为冲剂、片剂、颗粒、口服液、丸剂或滴丸。
4.权利要求1所述的用于逆转糖尿病的药食用组合物的制作方法，按质量称取各组分，将各食材研成粉末，放置容器中，混合均匀即可，所述的原料食材按质量计，包括人参3-10g，葫芦巴3-10g，玉米须1-5g，肉桂2-6g，桑叶1-5g，梨果仙人掌1-5g，丁香1-5g，小茴香1-5g，朝鲜蓟1-5g，苦瓜1-5g。
5.权利要求1所述的用于逆转糖尿病的药食用组合物作为逆转糖尿病的保健食品的应用。
6.权利要求1所述的用于逆转糖尿病的药食用组合物作为制备糖尿病药物的应用。
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Citations (2)
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| CN102727586A (zh) * | 2011-04-02 | 2012-10-17 | 苏州润新生物科技有限公司 | 预防和治疗糖尿病的组合物 |
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| CN102727586A (zh) * | 2011-04-02 | 2012-10-17 | 苏州润新生物科技有限公司 | 预防和治疗糖尿病的组合物 |
| CN104984331A (zh) * | 2015-07-08 | 2015-10-21 | 徐培良 | 生物活性多酶修复胰腺β细胞溶液制剂及其制备方法 |
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