CN110558569B - 包含酸性乳清衍生蛋白质的透明液体营养组合物 - Google Patents
包含酸性乳清衍生蛋白质的透明液体营养组合物 Download PDFInfo
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Abstract
本发明提供液体营养组合物，其是透明的，在室温以860nm波长测量的透光度为80‑90％，包含酸性乳清衍生蛋白质和高比例的糖类，提供了清爽果汁般的感觉以及清淡的口感和质地。该液体营养组合物用于中度至高度能量需求的患者的治疗中。
Description
技术领域
本发明涉及透明的液体营养组合物，其包含酸性乳清衍生蛋白质和糖类，且具有清爽的、果汁风格的感觉以及清淡的口感和质地。本发明的液体营养组合物是即用产品。本发明还涉及所述液体营养组合物在具有中度至高度能量需求的患者的治疗中的用途。
背景技术
经历营养不良或有营养不良风险的患者在每天摄入最少量的热量方面存在困难。以所需量摄取营养物的困难可能是由于老化或受损的胃肠功能，特别是脂肪吸收不良。
正在经历吸收不良的患者遭受肌肉损失，其通过提供包含小尺寸蛋白质的高热量营养组合物作为营养不全面的补充剂而得到缓解。在大多数情况下，这些蛋白质是乳蛋白。
在疾病的过程中，患者可能对乳状口服营养物产生厌恶或疲倦(“味觉疲劳”)，这降低了满足患者的每日营养目标的机会并使治疗成功处于风险之中。
因此，需要一种营养组合物，其满足患有营养不良或存在营养不良风险的患者的能量需求，并且提供清爽的、与乳状口服营养物截然不同的感觉和视觉吸引力，同时支持患者的蛋白质需求以缓解肌肉损失。此外，必须满足与肠内营养物有关的安全和监管标准。
发明内容
本发明的发明人惊讶地发现，酸性乳清衍生蛋白质赋予本文的液体营养组合物以清爽的、果汁风格的感觉以及清淡的口感和质地。此外，即使在不存在稳定剂的情况下，所述酸性乳清衍生蛋白质也能产生澄清和透明的液体组合物。再者，所述酸性乳清衍生蛋白质导致有利的储存稳定性，因为本文的液体营养组合物在运输和长期储存时保持澄清和透明。
所述液体营养组合物包含蛋白质组分和糖组分以满足能量需求。任选地，所述液体营养组合物另外包含维生素、痕量元素和无机物。所述液体营养组合物营养不全面，即它们适合作为营养补充剂，但不适合作为唯一的营养来源。优选地，所述液体营养组合物临床上不含乳糖、纤维、脂肪和谷蛋白。
在第一方面，本发明涉及液体营养组合物，其包含蛋白质组分和糖组分，其中所述蛋白质组分包含以10w/v％溶液测量的pH值为2.0-3.5的酸性乳清衍生蛋白质，其中所述液体营养组合物在室温以860nm波长测量的透光度为80-90％，能量密度为1.0-2.0kcal/ml，且pH值为2.0-4.0。
在第二方面，本发明涉及所述液体营养组合物用于治疗或预防老年患者或患有脂肪吸收不良的患者的蛋白质能量营养不良的用途。
在本说明书以及从属权利要求中描述了本发明的优选实施方案。
具体实施方案
定义
本文使用的“热量密度(Caloric density)”或“能量密度(energy density)”是指本文中每体积液体营养组合物提供的热量的量。液体营养组合物的热量密度为1.0-2.0kcal/mL，优选1.3-1.8kcal/mL，更优选1.5kcal/ml。
“啜饮料(sip feed)”在本文中是指可直接通过吸管从容器中摄取的溶液。或者，该溶液可倒入玻璃杯中并被吞服。
本文的液体营养组合物不是营养全面的。当常规膳食无法满足能量需求时，它们充当待施用的营养补充剂。根据本公开的合适营养剂满足法规(EU)No 609/2013的要求/列出的要求。
如本文所用的“蛋白质组分”是指本文的液体营养组合物中可被称为“蛋白质”的全部成份。如本文所用的“糖组分”是指本文的液体营养组合物中可被称为“糖”的全部成份。“基本上由一种或多种成份组成”的组分应理解为包含至少95重量％、优选至少98重量％的指定成份，其余百分比为杂质。
如本文所用的“营养不良”是指选项I和选项II中的一项或两项，选项I：体重指数(BMI，kg/m2)<18.5；选项II：一并发现非故意的体重减轻(必要)以及或者是降低的BMI或者是低无脂质量指数(FFMI)中的至少一种。体重减轻定义为不确定时间的情况下习惯性体重的>10％，或3个月内>5％。在年龄小于70岁的受试者以及年龄大于70岁的受试者中，降低的BMI分别为<20或<22kg/m2。女性和男性的低FFMI分别为<15和<17kg/m2。
蛋白质组分
蛋白质组分包含一种或多种选自酸性乳清衍生蛋白质和水解乳清蛋白的蛋白质源。酸性乳清衍生蛋白质以10w/v％溶液测量的pH值为2.0-3.5，优选2.5-3.0。酸性乳清来源的蛋白质选自酸化的乳清蛋白、酸化的乳清蛋白分离物和酸化的乳清蛋白浓缩物。
优选地，蛋白质来源选自酸化的乳清蛋白分离物，其以10w/v％溶液测量的pH值为2.0-3.5，优选2.5-3.0。这种酸性乳清具有以下优点：即使在不存在稳定剂的情况下，液体营养组合物也是澄清且透明的，并且在长期储存时仍保持如此。此外，酸性乳清衍生蛋白质赋予本文的液体营养组合物清爽的、果汁风格的感觉和清淡的口感和质地。
本文的液体营养组合物包含乳清衍生蛋白质，因为它是非常丰富的必需氨基酸来源，尤其是支链氨基酸(BCAA)。BCAA，特别是亮氨酸，是蛋白质折叠的强力调节剂，并被认为在运动期间或之后增加蛋白质合成。乳清衍生蛋白质在老年人中是肌肉合成的极佳刺激物；并且在健康成人中，与其他蛋白质来源相比，乳清与阻力训练结合使瘦体重增加更多。乳清蛋白还特别富含半胱氨酸，这是参与免疫功能的抗氧化剂谷胱甘肽的前体。研究表明，乳清蛋白改善健康和免疫受损个体中的谷胱甘肽水平。简而言之，存在于本文的液体营养组合物中的蛋白质组分刺激肌肉积聚和抗氧化防御。
基于本文的液体营养组合物的总体积，所述蛋白质组分通常以2-7w/v％、优选3-5w/v％、最优选4w/v％存在。
优选地，基于本文的液体营养组合物的总能量，所述蛋白质组分提供5-15EN％、更优选7-13EN％，最优选11EN％。
糖组分
糖组分包含一种或多种选自多糖、寡糖和单糖的可消化的糖源。
优选地，可消化的糖源选自蔗糖、麦芽糖、葡萄糖、麦芽糊精、淀粉、水解淀粉、玉米淀粉、玉米糖浆、玉蜀黍糖浆、葡萄糖浆及其混合物。更优选地，可消化的糖源选自蔗糖、麦芽糖、葡萄糖、麦芽糊精和葡萄糖浆。
在一个实施方案中，所述糖组分包含蔗糖、麦芽糖、葡萄糖、麦芽糊精和葡萄糖浆。
优选地，麦芽糊精的葡萄糖当量(DE)为9-19，更优选为11-16。优选地，葡萄糖浆的DE为26-34，优选为28-32。根据欧洲药典的方法测量DE。
在一个实施方案中，糖组分包含蔗糖、麦芽糖、葡萄糖、麦芽糊精(DE 11-16)和葡萄糖浆(DE 28-32)。
麦芽糊精衍生自玉米淀粉并且在水性介质中具有有利的溶解度。蔗糖的加入量为1-5w/v％，例如4w/v％，以赋予甜味。所述糖组分与蛋白质组分一起赋予本文的液体营养组合物以果汁风格的外观以及新鲜和清淡的口感。
基于本文的液体营养组合物的总体积，所述糖组分通常以25-40w/v％，优选30-35w/v％，最优选33w/v％存在。
优选地，基于本文的液体营养组合物的总能量，所述糖组分提供85-95EN％，优选87-93EN％，最优选89EN％。
维生素、痕量元素和无机物
本文的液体营养组合物包含维生素和痕量元素以提供平均每日需求，还包含无机物以增强无机物供应和对抗缺乏的无机物摄取。
在一个实施方案中，本文的液体营养组合物包含维生素A、β-胡萝卜素、维生素D3、维生素E、维生素K1、维生素B1、维生素B2、烟酸、维生素B6、维生素B12、泛酸、生物素、叶酸和维生素C(抗坏血酸)，其量为以每天2至3瓶即满足成人的平均每日需求。维生素优选通过使用麦芽糊精作为基质或载体的研磨物来添加。
在所述实施方案中，所述液体营养组合物还包含必需的痕量元素锌、铜、锰、碘、氟、铬、钼和硒，其量为以每天2至3瓶即满足成人的平均每日需求。痕量元素优选以使用麦芽糊精作为基质或载体的研磨物的形式加入。
在所述实施方案中，所述液体营养组合物还包含无机物钠、钾、钙、镁、氯化物、氟化物、碘化物、氧化物、磷酸盐、磷酸氢盐、焦磷酸盐、碳酸盐和硫酸盐。
在一个实施方案中，钙离子以0.03-0.07g/100ml、优选0.04-0.06g/100ml的量添加，以提供提高骨健康的推荐每日摄入量的约20％。钙优选作为氯化物以0.15-0.2g/100ml，优选0.16-0.19g/100ml的量添加。
添加剂
所述液体营养组合物任选包含食品添加剂。添加剂通常以小于5重量％的总量存在。基于所述液体营养乳液的总重量，它们优选以1-4重量％，优选1.5-2.5重量％的总量存在。示例性添加剂是着色剂、芳香剂、调味剂及其混合物。芳香剂和调味剂可以是中性的、柠檬、焦糖、香草、酸奶、巧克力、咖啡、卡布奇诺、水果香优选橙香。所述添加剂任选地包括、但优选不含稳定剂如微晶纤维素(E460)和羧甲基纤维素(E466)，乳化剂如脂肪酸的甘油单酯和甘油二酯的柠檬酸酯(E472c)，和增稠剂如黄原胶(E415)和液体消泡剂。优选地，液体甘油单酯和甘油二酯消泡混合物(E471)存在于本文的液体营养组合物中。
生产方法
本文所述的液体营养组合物通过使用标准分散混合器、优选高剪切混合器的一般湿混方法获得。
在这种方法的一个实施方案中，将粉末成份混合以提供预混物。在第二步中，将所述预混物在搅拌下给予所需量的水。在第三步中，在搅拌下加入非粉末状原料如芳香剂。然后将反应混合物通过本领域已知的程序并在本领域已知的条件下均化并进行高温热处理。
在该方法的另一个实施方案中，在第一步中将选择的粉末成份如糖类与水混合。在第二步中，将剩余的粉末成份单独混合得到预混物，然后将所述预混物加入到第一步中得到的混合物中。在第三步中，在搅拌下加入非粉末状原料如芳香剂。然后将反应混合物通过本领域已知的程序并在本领域已知的条件下均化并进行高温热处理。
在该方法的另一个实施方案中，在第一步中将选择的粉末成份如糖类与水混合。在第二步中，将选择的粉末成份单独混合得到预混物，然后将所述预混物加入到第一步中得到的混合物中。在第三步中，在搅拌下加入非粉末状原料如芳香剂。在第四步中，可以加入剩余的粉状成份，例如蛋白质。然后将反应混合物通过本领域已知的程序并在本领域已知的条件下均化并进行高温热处理。
本领域技术人员清楚粉末形式的成份可在使用前过筛或研磨以减小粒度并增加均匀性和溶解度。
透光度测量
所述液体营养组合物具有80-90％，优选85-90％的透光度。为了获得透光度值，在室温下在10mm比色皿(聚甲基丙烯酸甲酯；PMMA)中参照给出100％透光度的蒸馏水测量未稀释的组合物。使用光谱光度计Shimadzu UV-1800进行测量，其设定为860nm的波长。测量遵循根据欧洲药典的方法5.0和2.2.1以及EN ISO 7027的指南。
由于具有80-90％、优选85-90％的透光度，本文的液体营养组合物是澄清和透明的。这促成了与乳状口服营养物的截然不同的感觉和视觉吸引力，并且增强了本文的液体营养组合物的清爽、果汁风格的感觉以及清淡的口感和质地。
物理参数
本文的液体营养组合物可具有2.0-4.0、优选2.5-3.5、更优选2.8-3.1的pH值，从电位测量得到。
本文的液体营养组合物通常具有1.12-1.16g/ml、优选1.13-1.14g/ml的密度，在20摄氏度测量。
本文的液体营养组合物通常具有630至1170、优选800-1000mosmol/kg水的渗透压，使用渗透压仪VaproTMModell 5520和5600根据程序AA/1.07/PU003通过降低蒸气压测量。
本文的液体营养组合物通常具有5-15mPa·s的粘度，在20摄氏度和100/s的剪切速率下测量。粘度使用HaakeRheostress 1(Thermo Fisher Scientific)测量，其配有具有转子DG43作为内嵌物(DIN 53544Titan)的测量杯DG43(系列1)，产生双缝(间隙)几何尺寸。
在患者治疗中的用途
本文的液体营养组合物对于具有中度至高度能量需求的患者和具有营养不良、特别是能量营养不良风险或受营养不良、特别是能量营养不良影响的患者是有益的，这些患者不能仅通过普通食物满足其营养需求。营养不良是一个严重的健康问题，在疾病、创伤和手术之后或期间会损害恢复和康复。
本文的液体营养组合物特别用于老年患者、遭受胃肠功能受损的患者，胃肠功能受损特别是在诸如短肠综合征、胰腺炎、囊性纤维化、胆汁淤积性肝病和化疗或放疗诱导的肠炎等疾病中发生的脂肪吸收不良。所述液体营养组合物特别用于患有蛋白质能量营养不良和/或脂肪吸收不良的患者，尤其是老年患者。
本文的液体营养组合物增加患者的能量和营养摄入，改善体重，改善骨骼健康并降低骨折风险，减少体重减轻并增加肌肉力量。
热量密度和每日剂量
本文的液体营养组合物适合作为啜饮物。
本文的液体营养组合物具有1.0-2.0kcal/mL、优选1.5kcal/ml的热量密度。
本文的液体营养组合物用作补充营养物，提供例如每剂量单位300kcal，其中一个剂量单位具有200ml的体积。
本文的液体营养组合物对于青少年和成人每天应消耗2至3份，各200mL，每天提供600-900kcal；对于小童(1-3周岁)，每天1至2份(300-600kcal每天)；并且对于大童，每天1至3份(300-900kcal)。
实施例
实施例1
液体营养组合物根据下文描述的方法制备：
实施例2-消光测量
制备了五种本文的液体营养组合物，其具有不同的风味，例如橙子、苹果和菠萝。然后如下进行三批橙子装料、一批苹果装料和一批菠萝装料的透光度测量：将未稀释的组合物在室温下放入10mm PMMA-比色皿中。使用光谱光度计Shimadzu UV-1800进行测量，将其设定为860nm的波长。参比溶液是给出100％透光度的蒸馏水。测量遵循根据欧洲药典方法5.0和2.2.1以及EN ISO 7027的指导。三批橙味液体营养组合物具有87.7％、87.9％和88.5％的透光度值。苹果味液体营养组合物具有87.1％的透光度，而菠萝味液体营养组合物具有87.0％的透光度。为了比较，测量了牛奶，得到0％的透光度。
Claims (7)
1.液体营养组合物，其包含蛋白质组分和糖组分，其中所述蛋白质组分包含以10 w/v%溶液测量的pH值为2.0-3.5的酸性乳清衍生蛋白质，且其中所述液体营养组合物在室温以860 nm波长测量的透光度为80-90 %，能量密度为1.0-2.0 kcal/ml，且pH值为2.0-4.0，其中所述蛋白质组分作为酸化的乳清蛋白分离物添加，并且所述液体营养组合物以0.045-0.06 g/ 100ml的量包含钙离子，并且所述钙离子作为氯化物以0.15-0.2 g/100 ml的量添加。
2. 根据权利要求1所述的液体营养组合物，其中所述酸性乳清衍生蛋白质以10 w/v%溶液测量的pH值为2.5-3.0。
3.根据权利要求1所述的液体营养组合物，其中所述糖组分选自葡萄糖、麦芽糖、蔗糖、麦芽糊精、淀粉、水解淀粉、玉米糖浆、葡萄糖浆及其混合物。
4.根据权利要求3所述的液体营养组合物，其中所述糖组分含有葡萄糖浆DE28-32、麦芽糊精DE11-16、葡萄糖、麦芽糖和蔗糖。
5. 根据权利要求1或2中任一项所述的液体营养组合物，其中基于所述液体营养组合物的总能量，所述蛋白质组分提供5-15 EN%且所述糖组分提供85-95 EN%。
6. 根据权利要求1-4中任一项所述的液体营养组合物，其中所述蛋白质组分以2-7 w/v%存在，且所述糖组分以25-40w/v%存在。
7. 根据权利要求5中所述的液体营养组合物，其中所述蛋白质组分以2-7 w/v%存在，且所述糖组分以25-40w/v%存在。
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| US5641531A (en) * | 1995-09-28 | 1997-06-24 | Abbott Laboratories | Nutritional liquid supplement beverage and method of making same |
| CN101925307A (zh) * | 2007-12-05 | 2010-12-22 | 荷兰纽迪希亚公司 | 高能量液体肠营养组合物 |
| CN102083329A (zh) * | 2008-03-12 | 2011-06-01 | 荷兰纽迪希亚公司 | 高蛋白液体肠营养组合物 |
| CN102665736A (zh) * | 2009-12-24 | 2012-09-12 | N.V.努特里西阿公司 | 用于刺激肌肉蛋白合成的低热量高蛋白营养组合物 |
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| US5641531A (en) * | 1995-09-28 | 1997-06-24 | Abbott Laboratories | Nutritional liquid supplement beverage and method of making same |
| CN101925307A (zh) * | 2007-12-05 | 2010-12-22 | 荷兰纽迪希亚公司 | 高能量液体肠营养组合物 |
| CN102083329A (zh) * | 2008-03-12 | 2011-06-01 | 荷兰纽迪希亚公司 | 高蛋白液体肠营养组合物 |
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