CN110122862A - 一种降低血糖的特殊医学用途食品及其制备方法 - Google Patents
一种降低血糖的特殊医学用途食品及其制备方法 Download PDFInfo
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Abstract
本申请公开一种特殊医学用途食品，所述特殊医学用途食品包含蛋白质13重量％‑17重量％，维生素0.5重量％‑1.5重量％，矿物质4重量％‑7重量％，碳水化合物30重量％‑40重量％，脂肪8重量％‑1O重量％，膳食纤维30重量％‑43重量％，氨基酸1重量％‑1.5重量％和核苷酸0.01重量％‑0.02重量％。本申请的特殊医学用途食品具有降低血糖的作用。
Description
技术领域
本申请涉及特殊医学食品领域，尤其涉及一种降低血糖的特殊医学用途食品及其制备方法。
背景技术
糖尿病是一组以高血糖为特征的代谢性疾病。高血糖则是由于胰岛素分泌缺陷或其生物作用受损，或两者兼有而引起。糖尿病时长期存在的高血糖，导致各种组织，特别是眼、肾、心脏、血管、神经的慢性损害、功能障碍。引起糖尿病的病因复杂，目前比较认可的因素有遗传原因、病毒感染原因、自身免疫原因，其他疾病的继发原因等，但是最大原因还是饮食的问题。随着人民生活条件越来越好，精致饮食，高糖饮食，高蛋白高脂饮食，饮食不规律，饮酒，吸烟等不良习惯，加上缺乏足够运动来消耗所摄入能量，能量过剩而引起糖尿病。目前治疗糖尿病的主要是口服降糖药或者注射胰岛素，口服降糖药或者注射胰岛素虽然能控制血糖，但两者都有导致低血糖风险。所以在糖尿病早期如果通过合理的饮食控制跟运动能达到一定程度上控制血糖。如果患者在饮食上没有进行科学的控制，即使口服降糖药或者注射胰岛素对控制血糖的稳定也是有很大影响，血糖的波动对患者的健康也产生极大的影响，也大大的增加并发症的风险。
发明内容
基于以上的实际存在的问题，本申请提供了一种含有维生素K2，具有降低血糖的特医食品及制备方法。该特医食品优点是为高血糖患者提供满足身体代谢所需的优质蛋白质，多种维生素，矿物质，氨基酸，膳食纤维，脂肪，碳水化合物。该配方食品可以满足高血糖患者每天的营养需求，其中的分离大豆蛋白粉、浓缩大豆蛋白粉是植物蛋白，蛋白质含量较高，还含有其他的人体必须氨基酸，胆固醇更低；乳清蛋白有助于降低超重者的体重和餐后糖负荷，降低肥胖相关疾病发生的风险；高膳食纤维能增加饱腹感，低饱和脂肪，短链脂肪酸，有益于肠道有益菌的生长；低血糖生成指数碳水化合物的摄入，能减少其他不必要的能量摄入。其中维生素C可以清除活性氧(ROS)和活性氮(RNS)，保护脂质过氧化，改善空腹血糖，糖化血红蛋白，总胆固醇和三酰甘油水平；维生素E能能减轻血糖过高引起的血管损伤，预防并延缓并发症尤其是心血管并发症的发生；锌可以影响胰岛素的合成，贮存，分泌以及结构的完整性，调节胰岛素和受体水平，在物质代谢中起胰岛素样作用肉碱，牛磺酸和肌醇也有助于减轻高血糖糖尿病症状，减少并发症；尤其是其中所含的维生素K2能够增强胰岛素敏感性，改善胰岛素抵抗从而能有效降低血糖，血糖的有效控制也就能够最大限度的减少并发症的产生。
具体地，本申请提供了一种特殊医学用途食品，其中，所述特殊医学用途食品包含蛋白质13重量％-17重量％，维生素0.5重量％-1.5重量％，矿物质4重量％-7重量％，碳水化合物30重量％-40重量％，脂肪8重量％-10重量％，膳食纤维30重量％-43重量％，氨基酸1重量％-1.5重量％和核苷酸0.01重量％-0.02重量％。
在本申请中，所述特殊医学用途食品还可以包含特殊医学用途食品可接受的添加剂；
所述特殊医学用途食品可接受的添加剂可以选自润滑剂和润湿剂中的一种或两种。
在本申请中，所述特殊医学用途食品可以为口服制剂，优选地片剂或颗粒剂。
在本申请中，所述特殊医学用途食品可以为分散片、含化片或口嚼片。
在本申请中，所述蛋白质可以选自大豆蛋白粉、核桃粉、小麦粉和乳清蛋白中的任一种或更多种；
所述大豆蛋白可以为分离大豆蛋白粉或浓缩大豆蛋白粉；
所述乳清蛋白可以为分离乳清蛋白或浓缩乳清蛋白。
在本申请中，所述维生素可以选自维生素A、B族维生素、D族维生素、氧化胆碱、维生素E、维生素C、D-生物素、烟酸、肌醇、D-泛酸钙、叶酸、维生素K2和维生素K1中的任一种或更多种；
所述维生素A可以为类胡萝卜素前体物质；
所述B族维生素可以选自维生素B1、维生素B2、维生素B6、维生素12、维生素B1前体、维生素B2前体、维生素B前体6和维生素12前体中的任一种或更多种；
所述D族维生素可以选自D2、维生素D3、维生素D2前体和维生素D3前体中的任一种或更多种，优选维生素D3；
所述维生素K2可以选自化学合成或天然发酵的MK1至MK14中的任一种或更多种，优选天然发酵的MK-7。
维生素K2，也称甲基萘醌(Menaquinone)，通常用MK来表示。它由一组化合物组成，共有14种形式，差别在于侧链的长短不一。MK是一系列含有2-甲基-1，4-萘醌母核及C3位带有数目不等的异戊二烯结构单元的萜烯侧链化合物的统称，根据萜烯侧链上碳元素的数目，可分为K2(10)、K2(20)、K2(35)、K2(40)等，K2(35)就是代表MK-7。
在本申请的一些实施方案中，所述特殊医学用途食品可以包含蛋白质13重量％-17重量％，维生素0.5重量％-1.5重量％，矿物质4重量％-7重量％，碳水化合物30重量％-40重量％，脂肪8重量％-10重量％，膳食纤维30重量％-43重量％，氨基酸1重量％-1.5重量％和核苷酸0.01重量％-0.02重量％。所述特殊医学用途食品还可以包含特殊医学用途食品可接受的添加剂；所述特殊医学用途食品可接受的添加剂可以选自润滑剂和润湿剂中的一种或两种。所述蛋白质可以选自大豆蛋白粉、核桃粉、小麦粉和乳清蛋白中的任一种或更多种。所述维生素可以选自维生素A、B族维生素、D族维生素、氧化胆碱、维生素E、维生素C、D-生物素、烟酸、肌醇、D-泛酸钙、叶酸、维生素K2和维生素K1中的任一种或更多种；所述维生素A可以为类胡萝卜素前体物质；所述B族维生素可以选自维生素B1、维生素B2、维生素B6、维生素12、维生素B1前体、维生素B2前体、维生素B前体6和维生素12前体中的任一种或更多种；所述D族维生素可以选自D2、维生素D3、维生素D2前体和维生素D3前体中的任一种或更多种，优选维生素D3；所述维生素K2可以选自化学合成或天然发酵的MK1至MK14中的任一种或更多种，优选天然发酵的MK-7。
在本申请的一些实施方案中，所述特殊医学用途食品可以包含蛋白质13重量％-17重量％，维生素0.5重量％-1.5重量％，矿物质4重量％-7重量％，碳水化合物30重量％-40重量％，脂肪8重量％-10重量％，膳食纤维30重量％-43重量％，氨基酸1重量％-1.5重量％和核苷酸0.01重量％-0.02重量％。所述特殊医学用途食品还可以包含特殊医学用途食品可接受的添加剂；所述特殊医学用途食品可接受的添加剂可以选自润滑剂和润湿剂中的一种或两种。所述蛋白质可以选自大豆蛋白粉、核桃粉、小麦粉和乳清蛋白中的任一种或更多种。所述维生素可以选自维生素A、B族维生素、D族维生素、氧化胆碱、维生素E、维生素C、D-生物素、烟酸、肌醇、D-泛酸钙、叶酸、维生素K2和维生素K1中的任一种或更多种；所述维生素A可以为类胡萝卜素前体物质；所述B族维生素可以选自维生素B1、维生素B2、维生素B6、维生素12、维生素B1前体、维生素B2前体、维生素B前体6和维生素12前体中的任一种或更多种；所述D族维生素优选地为维生素D3；所述维生素K2优选地为天然发酵的MK-7。
在本申请中，所述矿物质可以选自含钠离子的矿物质、含钾离子的矿物质、含铜离子的矿物质、含镁离子的矿物质、含铁离子的矿物质、含锌离子的矿物质、含锰离子的矿物质、含钙离子的矿物质、含碘离子的矿物质、含硒离子的矿物质中的任一种或更多种。
在本申请中，所述氨基酸可以选自L-赖氨酸、L-亮氨酸、L-异亮氨酸、L-精氨酸、左旋肉碱和牛磺酸的任一种或更多种。
在本申请中，所述核苷酸可以选自肌苷酸二钠、鸟苷酸二钠、胞甘酸二钠和尿苷酸二钠中的任一种或更多种。
在本申请中，所述脂肪可以选自植物油、亚油酸、亚麻酸、中链脂肪酸甘油酯和长链脂肪酸甘油酯中的任一种或更多种。
在本申请中，所述膳食纤维可以选自可溶性膳食纤维和不溶性膳食纤维中的一种或两种；
所述可溶性膳食纤维可以选自豆胶、果胶、树胶和低聚果糖中的任一种或更多种；所述不溶性膳食纤维可以选自纤维素、半纤维素和木质素中的任一种或更多种。
在本申请中，所述碳水化合物可以选自藕粉、莲子粉和山药粉或全麦粉中的任一种或更多种。
本申请还提供所述特殊医学用途食品的制备方法，所述制备方法包括：
将蛋白质、维生素、矿物质、碳水化合物、脂肪、膳食纤维和氨基酸混合。
在本申请中，所述制备方法包括：
将蛋白质、维生素、矿物质、碳水化合物、脂肪、膳食纤维和氨基酸在温度18℃-22℃，湿度45％-65％下混合混匀，然后加入特殊医学用途食品可接受的添加剂，获得所述口服制剂。
本申请还提供所述特殊医学用途食品用于降低血糖的用途。
本申请的特殊医学用途食品改善胰岛素抵抗从而能有效降低血糖，减少并发症的产生。
本申请的其它特征和优点将在随后的说明书中阐述，并且，部分地从说明书中变得显而易见，或者通过实施本申请而了解。本申请的目的和其他优点可通过在说明书以及权利要求书中所特别指出的结构来实现和获得。
具体实施方式
为使本申请的目的、技术方案和优点更加清楚明白，下文中将对本申请的实施例进行详细说明。需要说明的是，在不冲突的情况下，本申请中的实施例及实施例中的特征可以相互任意组合。
实施例
一、按配方比例称量所需各种原料，
1)将所述维生素包括维生素A醋酸视黄酯(10％)12mg、【B族维生素(维生素B19mg、维生素B2 9mg、维生素B6 9mg，维生素B12(0.1％)1.5mg】，维生素D3(0.25％)11mg、胆碱2.4g、维生素E 74mg、维生素C 308mg、D-生物素2％7mg、烟酸19mg、肌醇2.4g、D-泛酸钙25mg、叶酸0.72mg，维生素K2(0.2％)0.2g、维生素K1 0.25mg以上各种维生素先采用等量递增的方法手工混合，再过60目不锈钢筛网3次得到混合均匀粉1。
2)将所述矿物质氯化钠7.5g、磷酸二氢钾8.5g、葡萄糖酸铜18.6mg、硫酸镁3g、柠檬酸亚铁1.6g、葡萄糖酸锌350mg、硫酸锰16.8mg、碳酸钙7g、碘化钾0.3mg、富硒酵母0.25g以上矿物质先采用等量递增的方法手工混合，再过60目不锈钢筛网3次得到混合均匀粉2。
3)将所述氨基酸可以是L-赖氨酸0.8g、L-亮氨酸1.3g、L-异亮氨酸0.9g、L-精氨酸0.8g、左旋肉碱1.0g、牛磺酸1g，以上氨基酸采用等量递增的方法手工混合，再过60目不锈钢筛网3次得到混合均匀粉料3。
4)将所述膳食纤维可溶性膳食纤维：豆胶18g，果胶17g，树胶16g，低聚果糖56g；不溶性膳食纤维：纤维素19g，半纤维素20g，木质素12g。先采用等量递增的方法手工混合，再过60目不锈钢筛网3次得到混合均匀粉料。
5)将所述脂肪的植物油6g、亚油酸8g、亚麻酸10g、中链脂肪酸甘油酯10g、长链脂肪酸甘油酯6g中的植物油、亚油酸、亚麻酸先采用与等量4)粉稀释，再加入中链脂肪酸甘油酯、长链脂肪酸甘油酯进行混合，再过60目不锈钢筛网3次得到混合均匀粉料4。
6)所述碳水化合物藕粉38g，莲子粉40g，山药粉50g，全麦粉30g先采用等量递增的方法手工混合，再过60目不锈钢筛网3次得到混合均匀粉料6。
7)将所述核苷酸包括肌苷酸二钠30mg，鸟苷酸二钠20mg，胞甘酸二钠10mg，尿苷酸二钠10mg，先采用等量递增的方法手工混合，再过60目不锈钢筛网3次得到混合均匀粉料7。
8)将所述蛋白质的大豆蛋白粉27g，核桃粉15g，小麦粉14g，乳清蛋白粉12g，先采用等量递增的方法手工混合，再过60目不锈钢筛网3次得到混合均匀粉料8。
以上的操作环境都是在十万级洁净车间完成，温度18-22℃，湿度是45-65％。
二、将以上粉料1-8在依次置于GHL-300B高效湿法混合制粒机中混合均匀，再加入所需的(1-2％按物料重量计)硬脂酸镁或者浓度10％淀粉浆10％-15％(按重量计)制成口服制剂。
三、本申请制剂的降血糖效果。
随机选取50名二型糖尿病患作为志愿者并签署知情同意书，将志愿者随机分成两组，对照组和治疗组，其中对照组共25例，年龄最小30岁，最大60岁，平均(45.5±7.91)岁，男14例，女11例。治疗组共25例，年龄最小28岁，最大58岁，平均(46.63±7.68)岁，男15例，女10例。对照组每日三餐食用按照原方式进行，治疗组每日三餐前给予按照具体实施方式中实施例2的方法制备的粉剂，每次150g，用300ml的37-40℃的温开水冲调服用；两组人员餐前及餐后5min，0.5、1、2、3小时分别测其血糖，连续进行十天，实验期间两组人员中、晚餐种类和食用量相同，降糖药物的种类和使用剂量均保持不变；随后两组均继续治疗，以90天为一个疗程，一个疗程后评定对餐后血糖的影响。
试验结果：对照组和治疗组各个时段血糖(mmol/l)的变化(x±s)
表1治疗前对照组和治疗组的血糖水平
| 组别 | 空腹 | 餐后5min | 餐后0.5h | 餐后1h | 餐后2h | 餐后3h |
| 对照组 | 7.05±0.28 | 9.59±0.62 | 12.10±0.89 | 13.63±0.89 | 12.10±0.89 | 10.35±0.58 |
| 治疗组 | 7.12±0.27 | 9.53±0.38 | 11.30±0.63 | 10.36±0.70 | 10.36±0.59 | 9.65±0.68 |
表2一个疗程后，对照组和治疗组的血糖水平
| 组别 | 空腹 | 餐后5min | 餐后0.5h | 餐后1h | 餐后2h | 餐后3h |
| 对照组 | 7.12±0.32 | 9.28±0.32 | 11.80±0.45 | 13.31±0.74 | 11.60±0.25 | 10.15±0.53 |
| 治疗组 | 6.82±0.61 | 8.50±0.35 | 9.30±0.60 | 8.62±0.63 | 7.82±0.69 | 7.65±0.43 |
从表1和表2可以看出，在治疗前，对照组跟治疗组各个时段的血糖差异并不大，经过一个疗程的代餐饮食后，治疗组各个时段的血糖值都比对照组低，并且没有出现一个过高的峰值。说明本申请的特殊医学用途食品具有降低血糖的作用。
虽然本申请所揭露的实施方式如上，但所述的内容仅为便于理解本申请而采用的实施方式，并非用以限定本申请。任何本申请所属领域内的技术人员，在不脱离本申请所揭露的精神和范围的前提下，可以在实施的形式及细节上进行任何的修改与变化，但本申请的专利保护范围，仍须以所附的权利要求书所界定的范围为准。
Claims (15)
1.一种特殊医学用途食品，其中，所述特殊医学用途食品包含蛋白质13重量％-17重量％，维生素0.5重量％-1.5重量％，矿物质4重量％-7重量％，碳水化合物30重量％-40重量％，脂肪8重量％-10重量％，膳食纤维30重量％-43重量％，氨基酸1重量％-1.5重量％和核苷酸0.01重量％-0.02重量％。
2.根据权利要求1所述的特殊医学用途食品，所述特殊医学用途食品还包含特殊医学用途食品可接受的添加剂；
所述特殊医学用途食品可接受的添加剂选自润滑剂和润湿剂中的一种或两种。
3.根据权利要求1或2所述的特殊医学用途食品，其中，所述特殊医学用途食品为口服制剂，优选地片剂或颗粒剂。
4.根据权利要求3所述的特殊医学用途食品，其中，所述特殊医学用途食品为分散片、含化片或口嚼片。
5.权利要求1所述的特殊医学用途食品，其中，所述蛋白质选自大豆蛋白粉、核桃粉、小麦粉和乳清蛋白中的任一种或更多种；
所述大豆蛋白为分离大豆蛋白粉或浓缩大豆蛋白粉；
所述乳清蛋白为分离乳清蛋白或浓缩乳清蛋白。
6.根据权利要求1、2和5中任一项所述的特殊医学用途食品，其中，所述维生素选自维生素A、B族维生素、D族维生素、氧化胆碱、维生素E、维生素C、D-生物素、烟酸、肌醇、D-泛酸钙、叶酸、维生素K2和维生素K1中的任一种或更多种；
所述维生素A为类胡萝卜素前体物质；
所述B族维生素选自维生素B1、维生素B2、维生素B6、维生素12、维生素B1前体、维生素B2前体、维生素B前体6和维生素12前体中的任一种或更多种；
所述D族维生素选自D2、维生素D3、维生素D2前体和维生素D3前体中的任一种或更多种，优选维生素D3；
所述维生素K2选自化学合成或天然发酵的MK1至MK14中的任一种或更多种，优选天然发酵的MK-7。
7.根据权利要求1、2和5中任一项所述的特殊医学用途食品，其中，所述矿物质选自含钠离子的矿物质、含钾离子的矿物质、含铜离子的矿物质、含镁离子的矿物质、含铁离子的矿物质、含锌离子的矿物质、含锰离子的矿物质、含钙离子的矿物质、含碘离子的矿物质、含硒离子的矿物质中的任一种或更多种。
8.根据权利要求1、2和5中任一项所述的特殊医学用途食品，其中，所述氨基酸选自L-赖氨酸、L-亮氨酸、L-异亮氨酸、L-精氨酸、左旋肉碱和牛磺酸中的任一种或更多种。
9.根据权利要求1、2和5中任一项所述的特殊医学用途食品，其中，所述核苷酸选自肌苷酸二钠、鸟苷酸二钠、胞甘酸二钠和尿苷酸二钠中的任一种或更多种。
10.根据权利要求1、2和5中任一项所述的特殊医学用途食品，其中，所述脂肪选自植物油、亚油酸、亚麻酸、中链脂肪酸甘油酯和长链脂肪酸甘油酯中的任一种或更多种。
11.根据权利要求1、2和5中任一项所述的特殊医学用途食品，其中，所述膳食纤维选自可溶性膳食纤维和不溶性膳食纤维中的一种或两种；
所述可溶性膳食纤维选自豆胶、果胶、树胶和低聚果糖中的任一种或更多种；所述不溶性膳食纤维选自纤维素、半纤维素和木质素中的任一种或更多种。
12.根据权利要求1、2和5中任一项所述的特殊医学用途食品，其中，所述碳水化合物选自藕粉、莲子粉和山药粉或全麦粉中的任一种或更多种。
13.权利要求1至12中任一项所述的特殊医学用途食品的制备方法，所述制备方法包括：
将蛋白质、维生素、矿物质、碳水化合物、脂肪、膳食纤维和氨基酸混合。
14.根据权利要求13所述的制备方法，其中，所述制备方法包括：
将蛋白质、维生素、矿物质、碳水化合物、脂肪、膳食纤维和氨基酸在温度18℃-22℃，湿度45％-65％下混合混匀，然后加入特殊医学用途食品可接受的添加剂，获得所述口服制剂。
15.根据权利要求1至12中任一项所述的特殊医学用途食品用于降低血糖的用途。
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