CN113384654A - 一种降糖组合物及其制备方法和应用 - Google Patents
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Abstract
本发明提供一种降糖组合物及其制备方法和应用，所述降糖组合物包括以下组分，山梨糖醇；微晶纤维素；桑叶粉；肉桂粉；白芸豆粉；辣木叶粉；葛根粉；陈皮粉；甘草粉；桑葚粉；栀子粉；茯苓粉；山药粉；白扁豆粉；余甘子粉；人参粉；黄精粉；枸杞子粉；鱼腥草粉；食用非活性酵母粉；二氧化硅；硬脂酸镁。本发明提供的组合物各组分采用科学配伍原则，各组分之间协同增效，对降糖有显著的效果。
Description
技术领域
本发明属于功能食品技术领域，具体涉及一种降糖组合物及其制备方法和应用。
背景技术
糖尿病是一种慢性病，当胰腺产生不了足够的胰岛素或者人体无法有效地利用所产生的胰岛素时，就会出现糖尿病。胰岛素是一种调节血糖的荷尔蒙。高血糖症或血糖升高，是糖尿病不加控制的一种通常结果，随着时间的推移会对人体的许多系统带来严重损害，特别是神经和血管。糖尿病患者中有绝大多数属于二型糖尿病，这种类型糖尿病主要是体重超重和缺乏身体活动的结果。每年370万人死于糖尿病，60％的糖尿病患者在亚太地区发生糖尿病海啸，超过1/3的中国成年人患有糖尿病：3.9亿人。糖尿病已经成为一场慢灾难。
因而对于下列人群降糖控糖至关重要，(1)肥胖人群；(2)血糖不耐受的糖尿病前期人群；(3)长期口服降糖药患者：(4)靠注射胰岛素控制血糖的糖尿病患者。目前市场上针对以上人群并没有效果较好的降糖产品。
公开号为CN110353146A的发明专利申请公开了一种糖尿病人专用桑叶复合降糖固体饮料的配方，可用于糖尿病人的餐后血糖控制。所述饮料以桑叶提取物，红景天提取物，山药提取物为主要原料，以绿茶粉，菊花粉，蛹虫草粉，赤小豆粉，木耳粉，葛根粉，银耳粉，五味子粉，金银花粉，蒲公英粉，南瓜粉，黄精粉，木糖醇，β-环糊精为辅料作为辅料加工而成。该发明采用真空冻干结合常温湿法造粒技术可有效避免原料中活性成分的破坏，且最大程度地保留其风味。乙醇湿法造粒技术所得颗粒粒径相似，粒度均匀，色泽良好，溶解性佳。本产品可以用于糖尿病人功能保健食品，也可用于偶见血糖异常升高的健康人群的日常防护食品。该发明中将具有降糖作用的多种药食同源组分进行组合，虽然有一定的降糖作用但其作用机制不明确。
发明内容
为解决现有技术中存在的问题，本发明提供了一种降糖组合物，包括以下组分，山梨糖醇；微晶纤维素；桑叶粉；肉桂粉；白芸豆粉；辣木叶粉；葛根粉；陈皮粉；甘草粉；桑葚粉；栀子粉；茯苓粉；山药粉；白扁豆粉；余甘子粉；人参粉；黄精粉；枸杞子粉；鱼腥草粉；食用非活性酵母粉；二氧化硅；硬脂酸镁。
本发明采用的原料具有以下功效：
桑叶粉：《神农本草经》中记载有性寒，味甘苦，具有疏散风热、清肺润燥、情感明目的功能，称桑叶为“神仙叶”，具有滋阴补血，益肝通气，降压利尿之功效，《本草纲目》中记载桑叶乃手足阳明之药，汁煎代茗，能止消渴，明目长发，其中“消渴”即为缓解糖尿病的症状。
肉桂粉：《神农本草经》：“味辛温，主百病，养精神，和颜色，利关节，补中益气。为诸药先聘通使，久服通神，轻身不老。面生光华，眉好常如童子。”《本草纲目》：“坚筋骨，通血脉，宜导百药，久服，神仙，不老。”其中活性物质type-A polymer通过刺激胰岛β细胞释放，促进血糖的代谢分解，肉桂中活性物质通过刺激胰岛β细胞释放，提高内胰岛素敏感性，减少肠内葡萄糖摄入量而产生抗糖尿病效应。
白芸豆粉：白芸豆粉-ɑ淀粉酶抑制剂，可以阻断淀粉分解成麦芽糖，从而具有调控血糖的作用。α-淀粉酶抑制剂存在于豆类的蛋白质成分中，这种蛋白质与α-淀粉酶的活性部位相结合，阻止淀粉的代谢活动，因此它又被称为“淀粉吸收阻断剂”，白芸豆提取物能减少人体淀粉的消化以及减少94％至99.9％肠淀粉酶活性，可以控制餐后血糖上升，控制餐后胰岛素水平。
辣木叶粉：辣木叶粉有降血糖、降脂、降压、抗肿瘤、抗氧化、通便、利尿、驱虫、改善睡眠等功效，长期食用可增强人体免疫功能，延缓衰老、预防疾病。辣木叶可以从改善胰岛素抵抗，抑制肝脏糖异生，保护胰岛β细胞，促进胰岛素分泌，抗炎，抗氧化，调节免疫以及参与抑制小肠蔗糖酶、胰α淀粉酶活性等多面发挥降糖作用。
葛根粉：具有清热解毒、滋补营养、防暑降温、养颜护肤、清除体内垃圾之功效，对风火牙疼、口腔溃疡、咽喉肿痛、热咳、高热、头痛等有明显疗效，对预防和治疗高血压、高血脂、冠心病、糖尿病等有特殊功效。
陈皮粉：具理气降逆、调中开胃、燥湿化痰之功。主治脾胃气滞湿阻、胸膈满闷、脘腹胀痛、不思饮食、呕吐秽逆、二便不利、肺气阻滞、咳嗽痰多，亦治乳痈初起。
甘草粉:味甘，性平。归入心，脾，肺，胃经。具有润肺止咳，补脾益气，缓和药性，清热解毒的功效。经常用于治疗脾胃虚弱，心悸，气短，倦怠无力，咳嗽痰多，脘腹和四肢疼痛，痈肿疮毒等症状。
桑葚粉:桑葚味甘性寒，入心肝、肾经，有滋阴补血作用，并能治阴虚津少、失眠等。另据许多古典中医文献记载：利五脏关节，通血气，安魂镇神，降压消渴，令人聪目，变白不老，解中酒毒等功效。现代医学临床证明：桑葚有很好的滋补心、肝、肾，及养血祛风的功效。对降脂和减轻神经衰弱、动脉硬化、性功能衰弱、耳聋眼花、须发早白、内热消渴、血虚便秘、风湿关节疼痛均有显著疗效。
栀子粉:栀子性凉，具有泻火除烦以及护肝利胆、降压镇静、止血消肿等功效和作用，多用来治疗外感热病、血热妄行等症、黄疸型肝炎、扭挫伤等，还可辅助治疗高血压、糖尿病等症。栀子当中的去羟栀子苷是一种具有促进胰腺分泌等作用的物质，同时栀子粉还可以起到非常明显的降低胰淀粉酶和增加胰胆的流量等作用，因此适当使用栀子粉可以提高胰腺功能，预防糖尿病。
茯苓粉:茯苓粉是中药茯苓的粉末，常见有呈白色、浅灰色，冲泡后呈深灰色。性平、味甘、淡，含有三萜类、多聚糖类及胆碱、脂肪、卵磷脂、钾、镁等多种元素。具有利水渗湿、健脾宁心的功效。茯苓不仅可显著提高机体免疫能力，而且可使血液中氧合血红蛋白释放更多的氧，以供给组织细胞。
山药粉:可以降血脂、调理肠胃，可减少皮下脂肪堆积；能防止结缔组织的萎缩，预防类风湿关节炎等胶原病的发生。
白扁豆粉:健脾，化湿，消暑。主脾虚生湿，食少便溏，白带过多，暑湿吐泻，烦渴胸闷。
余甘子粉:甘子粉中含有丰富的维生素、胡萝卜素、脂肪酸等人体所需的各种营养元素，可以补充人体所必需的营养，而且还具有清热凉血，生津止咳的效果，同时还可以缓解一些消化不良、腹胀、腹痛、咳嗽等症状。同时它还具有抗菌、清热、润肺、消炎、抗氧化、抗衰老等效果，还对赤巴病、慢性咽炎、高血压、糖尿病、高脂血症等疾病的治疗效果显著。
人参粉:人参粉可大补元气、补五脏、益元气、通血脉、生津止渴、安神益智，主治劳伤虚损、劳累、反胃吐食、小儿慢惊及身体虚弱等症状。
黄精粉:黄精粉有增强人体的免疫力、抗肿瘤、抗菌消炎、降血脂、调节血压的作用。
枸杞子粉:枸杞子具有增强机体免疫功能，抑制肿瘤，降血糖，降血脂，抗疲劳等功能作用。
鱼腥草粉:消除浮肿，纤身塑容，抗菌消炎，祛痘，提高机体免疫力，清热解毒，化痰止咳，利尿。
食用非活性酵母粉:具有平衡免疫；改善过敏；加速炎症恢复；缓解感冒症状；增强粘膜抵御力；调节肠道菌群的功效。
本发明的作用机制为：如图1-2所示，本发明的组合物阻断淀粉分解成麦芽糖、同时阻断麦芽糖、蔗糖糖分解成葡萄糖，从而抑制葡萄糖吸收；激活β细胞的活性，促进更多的胰岛素的分泌；促进细胞、组织对葡萄糖的摄取和利用。从而达到调控血糖的目的。
优选的是，包括以下按质量份计的组分，山梨糖醇10-200份；微晶纤维素10-200份；桑叶粉50-300份；肉桂粉50-300份；白芸豆粉10-100份；辣木叶粉10-150份；葛根粉10-150份；陈皮粉10-150份；甘草粉10-150份；桑葚粉10-150份；栀子粉10-150份；茯苓粉10-150份；山药粉10-150份；白扁豆粉10-150份；余甘子粉10-150份；人参粉10-150份；黄精粉10-150份；枸杞子粉10-150份；鱼腥草粉10-150份；食用非活性酵母粉10-150份；二氧化硅10-150份；硬脂酸镁5-10份。
上述任一方案优选的是，所述桑叶粉为白桑叶粉，白桑叶提取物有降血糖作用，它包含一种叫做1-脱氧野尻霉素(1-deoxynojirimycin)的化合物，能帮助糖消化过程。大部分摄入的糖不会被吸收进血流，而是当做废物排出体外。白桑叶提取物有抑制身体吸收糖的作用，因此能防止脂肪形成。
上述任一方案优选的是，所述白芸豆粉中酶抑制活性高于20000单位/g。
本发明还提供一种上述任一方案降糖组合物的制备方法，将山梨糖醇、微晶纤维素与其他物料混合，用50％乙醇湿法制粒，50-60℃烘干、整粒，加二氧化硅，硬脂酸镁混合压片，片重0.6g/片。
本发明制备的降糖组合物可以应用于食品和饮料。
本发明制备的降糖组合物可以用于制备压片糖果。
有益效果：本发明提供的组合物各组分采用科学配伍原则，各组分之间协同增效。从阻断糖的吸收、促进胰腺分泌胰岛素、促进组织细胞对游离葡萄糖的摄取三方面调控血糖。功效成分明确、药效作用机制清晰。临床试验结果，显示安全有效。糖尿病前期患者服用本发明的组合物产品30天，平均血糖值从6.5mmol/l下降至5.2mmol，降至正常血糖水平，对前糖尿病的血糖控制效果显著，可防止进一步发展成糖尿病。糖尿病患者注射胰岛素同时服用本发明的组合物产品进行治疗效果确切，有效改善餐前血糖、餐后2h血糖水平。糖尿病患者单独服用本发明的组合物产品进行治疗效果显著，有效改善餐前血糖、餐后2h血糖水平。
附图说明
图1为糖类吸收途径图；
图2为本发明组合物的作用机制图；
图3为本发明实施例1组合物对糖尿病前期患者的降糖效果图；
图4为服用本发明实施例1组合物与胰岛素合用治疗3个月糖尿病患者餐前血糖对照图；
图5为服用本发明实施例1组合物与胰岛素合用治疗3个月糖尿病患者餐后2h血糖对照图；
图6为服用本发明实施例1组合物与胰岛素合用治疗3个月糖尿病患者血糖对照图；
图7为服用本发明实施例1组合物与口服降糖药合用治疗3个月糖尿病患者餐前血糖对照图；
图8为服用本发明实施例1组合物与口服降糖药合用治疗3个月糖尿病患者餐后2h血糖对照图；
图9为服用本发明实施例1组合物与口服降糖药合用治疗3个月糖尿病患者血糖对照图；
图10为服用本发明实施例1组合物与口服降糖药分别治疗3个月糖尿病患者餐前血糖对照图；
图11为服用本发明实施例1组合物与口服降糖药分别治疗3个月糖尿病患者餐后2h血糖对照图；
图12为服用本发明实施例1组合物与口服降糖药分别治疗3个月糖尿病患者血糖对照图；
具体实施方式
以下结合具体实例对本发明做进一步说明，但本发明的内容不仅仅局限于下面的实施例。
实施例1
采用以下按质量份计的组分，山梨糖醇10-200份；微晶纤维素10-200份；桑叶粉50-300份；肉桂粉50-300份；白芸豆粉10-100份；辣木叶粉10-150份；葛根粉10-150份；陈皮粉10-150份；甘草粉10-150份；桑葚粉10-150份；栀子粉10-150份；茯苓粉10-150份；山药粉10-150份；白扁豆粉10-150份；余甘子粉10-150份；人参粉10-150份；黄精粉10-150份；枸杞子粉10-150份；鱼腥草粉10-150份；食用非活性酵母粉10-150份；二氧化硅10-150份；硬脂酸镁5-10份。
具体制备方法为：将山梨糖醇、微晶纤维素与其他物料混合，用50％乙醇湿法制粒，50-60℃烘干、整粒，加二氧化硅，硬脂酸镁混合压片，片重0.6g/片。将其制备为压片糖果。
实施例2
对实施例1制备的压片糖果测试其降糖效果。
试验方法：
研究对象：糖尿病前期患者，30岁-60岁，男女各30人，共计60名试验对象，测得试验前平均空腹血糖值6.5mmol/l。
具体方法：患者均指导其科学饮食，运动锻炼，每餐饭前10分钟服用实施例1所制备的压片糖果，用温水送服，每次2片，0.6g/片，每天3次，于15天、30天测空腹血糖值。
评价标准：显效：空腹血糖控制在正常范围内；有效：空腹血糖较之前有明显下降未至正常范围；无效：空腹血糖下降不明显。总有效率为显效和有效的人数占比。
糖尿病前期患者服用本发明的组合物的平均空腹血糖结果如图3所示。
以上试验结果表明：糖尿病前期患者服用本发明的组合物30天，总有效率为100％，平均血糖值从6.5mmol/l下降至5.2mmol，降至正常血糖水平，
因此对前糖尿病的血糖控制效果显著，可防止进一步发展成糖尿病。
实施例3
对实施例1制备的降糖组合物的降糖效果进行测试。
研究对象：30岁-65岁，患者接受过精胰岛素治疗，男女各25人，共计50名试验对象，测得平均空腹血糖值9.6mmol/l。其中，对照组：50名患者为研究对象，观察组：对照组患者基础上随机选取35人，男17人，女18人。
具体方法：
两组均给予饮食以及运动等综合治疗。
对照组：50名患者根据自身血糖水平调整需求和实测数据调整剂量，每日注射1次胰岛素，所有患者均接受3个月治疗。
观察组：患者在对照组患者基础上随机选取35人，男17人，女18人，测得平均空腹血糖值9.55mmol/l，餐前10分钟服用实施例1制备的压片糖果，3次/天，2片/次，0.6g/片。所有患者均接受3个月治疗。
评价指标：显效：患者“三多一少”的症状明显改善，空腹血糖控制在正常范围内，餐后2小时血糖控制在正常范围内；有效：患者“三多一少”的有所缓解，空腹血糖较之前有明显下降未至正常范围，餐后2小时血糖较之前有明显下降未至正常范围；无效：患者“三多一少”的症状没有变化，空腹血糖以及餐后2小时血糖下降不明显。餐前血糖可反映胰岛β细胞功能，餐后2h血糖检测可在一定程度上反映患者体内胰岛素分泌的展开、胰岛素敏感程度，以下实施例也选用这两个指标来评价降糖效果。
3个月结果如下：
结果如图4-6所示：
(1)餐前血糖(空腹血糖)：对照组餐前血糖从9.6降到8.96mmol/l，下降率6.67％，观察组餐前血糖从9.55降到7.43mmol/l，下降率22.2％，效果明显优于对照组；
(2)餐后2h血糖：从12.8降到9.37mmol/l，下降率26.8％，观察组餐后2h血糖从13.36降到7.31mmol/l，下降率44.89％，效果明显优于对照组；
试验结果表明：糖尿病患者注射胰岛素同时服用实施例1制备的压片糖果进行治疗效果确切，三多一少的症状明显改善且有效改善餐前血糖、餐后2h血糖水平。
实施例4
对实施例制备的降糖组合物的降糖效果进行测试。
研究对象：服用二甲双胍治疗进行治疗的糖尿病患者，30岁-65岁，男女各35人，共计70名试验对象。二甲双胍是临床治疗糖尿病的代表药物，进入机体后可有效提高机体对葡萄糖的利用，减少肝糖原及肝脏葡萄糖的输出，加强受体与胰岛素结合，增加肌肉对葡萄糖的消耗，从而降低血糖水平，但二甲双胍无法刺激胰岛素分泌功能，使得部分患者的降糖效果常无法满足临床预期。
具体方法：
随机分两组，35人/组，两组均给予饮食以及运动等综合治疗。对照组：患者服用二甲双胍治疗，餐前15min口服，0.5～1.0mg/次，3次/d。治疗3个月检测空腹血糖和餐后2h血糖。
观察组：患者服用二甲双胍联合实施例1制备的压片糖果治疗：二甲双胍用药，餐前15min口服，0.5mg/次，3次/d；血糖不能有效控制，则需要添加本发明的压片糖果；保持3次/天，2片/次，0.6g/片。
评价指标：显效：患者“三多一少”的症状明显改善，空腹血糖控制在正常范围内，餐后2小时血糖控制在正常范围内；有效：患者“三多一少”的有所缓解，空腹血糖较之前有明显下降未至正常范围，餐后2小时血糖较之前有明显下降未至正常范围；无效：患者“三多一少”的症状没有变化，空腹血糖以及餐后2小时血糖下降不明显。
结果如图7-9所示：
(1)餐前血糖(空腹血糖)：对照组餐前血糖从11.88降到9.55mmol/l，下降率19.61％，观察组餐前血糖从11.65降到6.21mmol/l，下降率46.70％，效果明显优于对照组；
(2)餐后2h血糖：对照组从12.76降到9.87mmol/l，下降率22.65％，观察组餐后2h血糖从12.19降到8.37mmol/l，下降率31.34％，效果明优于对照组；
试验结果表明：糖尿病口服降糖药同时服用办发明的组合物进行治疗效果确切，三多一少的症状明显改善，且有效改善餐前血糖、餐后2h血糖水平。
实施例5
对实施例制备的降糖组合物的降糖效果进行测试。
研究对象：糖尿病患者40岁-71岁，男女各20人，共计40名试验对象。
具体方法：
随机分配对照组和观察组各20人。
对照组：患者口服盐酸二甲双胍片(每次0.85g，每日2次，连续治疗3个月。
观察组：患者口服实施例1制备的压片糖果3次/天，每日2片，0.6g/片，连续治疗3个月，比较两组患者治疗前后空腹血糖、餐后2h血糖指标。
评价指标：显效：患者“三多一少”的症状明显改善，空腹血糖控制在正常范围内，餐后2小时血糖控制在正常范围内；有效：患者“三多一少”的明显缓解，空腹血糖较之前有明显下降未至正常范围，餐后2小时血糖较之前有明显下降未至正常范围；无效：患者“三多一少”的症状没有变化，空腹血糖以及餐后2小时血糖下降不明显。
结果如图10-12所示：
(1)餐前血糖(空腹血糖)：对照组从9.79降到7.2mmol/l，下降率26.46％，观察组从9.91降到5.68mmol/l，下降率42.68％，效果明显优于对照组；
(2)餐后2h血糖：对照组从12.98降到10.3mmol/l，下降率20.65％，观察组从13.07降到7.1mmol/l，下降率45.68％，效果明显优于对照组；
试验结果表明：糖尿病患者服用本发明的组合物进行治疗效果显著，三多一少的症状明显改善且有效改善餐前血糖、餐后2h血糖水平。
综上，本发明制备的降糖组合物可以用于糖尿病前期患者，注射胰岛素患者以及口服降糖药的患者，都有明显的降糖效果，糖尿病患者单独服用本发明的组合物也可以达到很好的降糖效果。
本发明制备的降糖组合物还适用于减重人群餐前服用，结合每天1小时有氧运动，对减重有明显的效果，50名志愿者坚持服用一月，100％有效，50％减重6-8斤，30％减重10-13斤，20％减重3-4斤。
本领域技术人员不难理解，本发明包括上述发明内容和具体实施方式部分的任意组合，限于篇幅并为使说明书简明而没有将这些组合构成的方案一一描述。凡在本发明的精神和原则之内，所做的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。
Claims (8)
1.一种降糖组合物，包括以下组分，山梨糖醇；微晶纤维素；桑叶粉；肉桂粉；白芸豆粉；辣木叶粉；葛根粉；陈皮粉；甘草粉；桑葚粉；栀子粉；茯苓粉；山药粉；白扁豆粉；余甘子粉；人参粉；黄精粉；枸杞子粉；鱼腥草粉；食用非活性酵母粉；二氧化硅；硬脂酸镁。
2.如权利要求1所述的降糖组合物，其特征在于，包括以下按质量份计的组分，山梨糖醇10-200份；微晶纤维素10-200份；桑叶粉50-300份；肉桂粉50-300份；白芸豆粉10-100份；辣木叶粉10-150份；葛根粉10-150份；陈皮粉10-150份；甘草粉10-150份；桑葚粉10-150份；栀子粉10-150份；茯苓粉10-150份；山药粉10-150份；白扁豆粉10-150份；余甘子粉10-150份；人参粉10-150份；黄精粉10-150份；枸杞子粉10-150份；鱼腥草粉10-150份；食用非活性酵母粉10-150份；二氧化硅10-150份；硬脂酸镁5-10份。
3.如权利要求1所述的降糖组合物，其特征在于，所述桑叶粉为白桑叶粉。
4.如权利要求1所述的降糖组合物，其特征在于，所述白芸豆粉中酶抑制活性高于20000单位/g。
5.一种如权利要求1-4任意一项所述的降糖组合物制成的饮料。
6.一种如权利要求1-4任意一项所述的降糖组合物制成的食品。
7.一种如权利要求1-4任意一项所述的降糖组合物制成的压片糖果。
8.一种如权利要求1-4中任一项所述降糖组合物的制备方法，将山梨糖醇、微晶纤维素与其他物料混合，用50％乙醇湿法制粒，50-60℃烘干、整粒，加二氧化硅，硬脂酸镁混合压片，片重0.6g/片。
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| CN113855642A (zh) * | 2021-11-25 | 2021-12-31 | 中合泰克(南京)生物科技有限公司 | 一种降糖缓释片及其制备方法 |
| CN115067470A (zh) * | 2022-03-14 | 2022-09-20 | 盈来健康科技(北京)有限公司 | 一种能够控糖、补充营养的主食伴侣 |
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| CN113855642A (zh) * | 2021-11-25 | 2021-12-31 | 中合泰克(南京)生物科技有限公司 | 一种降糖缓释片及其制备方法 |
| CN115067470A (zh) * | 2022-03-14 | 2022-09-20 | 盈来健康科技(北京)有限公司 | 一种能够控糖、补充营养的主食伴侣 |
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