CN1310601C - 含核苷酸的婴儿配方 - Google Patents
含核苷酸的婴儿配方 Download PDFInfo
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- CN1310601C CN1310601C CNB2003801011516A CN200380101151A CN1310601C CN 1310601 C CN1310601 C CN 1310601C CN B2003801011516 A CNB2003801011516 A CN B2003801011516A CN 200380101151 A CN200380101151 A CN 200380101151A CN 1310601 C CN1310601 C CN 1310601C
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- Prior art keywords
- infant formula
- vitamin
- nucleotides
- preemie
- mcg
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Abstract
提供了婴儿配方组合物，其包含3.2mg/L-15.4mg/L的CMP；1.8mg/L-11.0mg/L的UMP；1.8mg/L-8.0mg/L的GMP；0.1mg/L-2.2mg/L的IMP；以及2.5mg/L-13.2mg/L的AMP。
Description
发明领域
本发明涉及含核苷酸的婴儿配方组合物。更具体地说，本发明涉及含核苷酸的早产或低出生体重婴儿的配方，该配方中核苷酸的含量适合于给早产婴儿喂食。
现有技术的说明
为了维持身体组织的迅速早期发育，早产婴儿需要增加营养。在儿科护理设备中，增加了低出生体重婴儿(LBW＞1000g)，特别是非常低出生体重婴儿(VLBW＜1000g)的存活率。但是，这些婴儿的内源性营养贮存能力是严重受限的。
早产婴儿与足月婴儿是显著不同的。最初的不成熟以及随后的迅速生长速度使得早产婴儿需要比足月婴儿摄入更高的营养。在过去的若干年中，营养学家在建立早产婴儿的营养需要方面取得了长足的进步，并因此调整了早产婴儿配方的组成。早产婴儿配方的组成主要是基于人母乳的组成在宫内的增长。因此，改进了早产婴儿的配方，其适当地增加营养成分，例如蛋白质和脂肪，以及矿物质，例如钙、磷、铜和锌的数量。
长期以来，人们需要给早产婴儿提供充分营养的手段。人们试图强化标准的婴儿配方，以改进早产婴儿的营养能力，特别是在早产婴儿的喂养中。
在所有的活细胞中都可以发现核苷酸。成熟的人母乳中含有十三种不同的核苷酸。其中，浓度最高的5种核苷酸是胞苷一磷酸(CMP)、鸟苷一磷酸(GMP)、腺苷一磷酸(AMP)、尿苷一磷酸(UMP)和肌苷一磷酸(IMP)。人乳中还含有能够有助于总核苷酸库(TNP)的核苷、核苷酸聚合物和核苷酸加合物。但是，在早产婴儿中，形成核苷酸的从头合成和补救方法可能是不足的。
为了模拟母乳和治疗某些特定的病症，已经在足月婴儿的婴儿配方中增加了核苷酸。
例如，US专利号5,492,899公开了一种含CMP、UMP、AMP和GMP的婴儿配方，以便提供一种增强免疫***和减轻腹泻的饮食配方。
美国专利号4,544,559公开了一种核苷酸丰富的用于婴儿营养的母乳化牛奶，其含有特定含量的AMP、CMP、GMP、IMP和UMP。
美国专利号4,994,442和5,086,500公开了向具有增强的生理特性的婴儿配方中加入核苷和核苷酸，其非常类似于母乳。
但是，没有公开向婴儿配方中加入核苷酸以模拟早产婴儿的母乳。假定从饮食中获得的核苷酸对早产婴儿的细胞生长、能量转移和促进内脏成熟和发育中起重要作用，因此是必不可少的。核苷酸还可以提供有利的生物学作用，包括增加有益的肠微生物群落，改进脂类代谢和增强免疫性。
发明概述
本发明涉及一种含有的总核苷酸浓度与早产婴儿母乳相似的婴儿配方组合物。本发明的婴儿配方组合物含有3.2mg/L-15.4mg/L的胞苷酸；1.8mg/L-11.0mg/L的UMP；1.8mg/L-8.0mg/L的GMP；0.1mg/L-2.2mg/L的IMP；以及2.5mg/L-13.2mg/L的AMP。
发明的详细说明
本发明的婴儿配方组合物中的核苷酸总浓度为9.3mg/L-49.8mg/L，优选为12.4mg/L-37.4mg/L，最优选为15.5mg/L-24.9mg/L.
本发明的婴儿配方组合物包含下列数量的核苷酸：
a)CMP：3.2mg/L-15.4mg/L，优选4.2mg/L-11.6mg/L；以及最优选5.3mg/L-7.7mg/L；
b)UMP：1.8mg/L-11.0mg/L，优选2.4mg/L-8.3mg/L；以及最优选3.0mg/L-5.5mg/L；
c)GMP：1.8mg/L-8.0mg/L，优选2.4mg/L-6.0mg/L；以及最优选3.0mg/L-4.0mg/L；
d)IMP：0.1mg/L-2.2mg/L，优选0.1mg/L-1.7mg/L；以及最优选0.1mg/L-1.1mg/L；以及
e)AMP：2.5mg/L-13.2mg/L，优选3.3mg/L-9.9mg/L；以及最优选4.1mg/L-6.6mg/L。
此外，本发明的婴儿配方可以与本领域中已知的其它营养有益的组分配制在一起，例如多不饱和脂肪酸(例如二十碳四烯酸和二十二碳六烯酸)。本发明的婴儿配方还可以含有在早产婴儿的饮食中必需的所有维生素和矿物质。这些维生素和矿物质应该以营养有效量存在。可以加入到本发明的婴儿配方组合物中的维生素和矿物质的例子包括维生素A、复合维生素B、维生素C、维生素D、维生素E、维生素K、钙、镁、钠、钾、磷、铜、锌、氯、碘、硒、铁、烟酸、叶酸、泛酸、生物素、胆碱、肌醇和锰。
本发明的婴儿配方组合物还可以包括有益于早产婴儿的大量营养素例如类胡萝卜素、牛磺酸、椰子油、向日葵油、大豆油、天然或合成脂肪、棕榈酸、中链苷油三酯、乳糖、麦芽糖糊精、葡萄糖、牛低聚糖或其馏分、脱脂奶、乳清、大豆蛋白质、水稻蛋白、蛋白质水解物和乳铁蛋白。
本发明的婴儿配方，其特别适于早产或低出生体重婴儿的喂养，含有在早产婴儿母亲的母乳中测得的水平的核苷酸。这些水平与在足月婴儿母亲的母乳测得的核苷酸的水平完全不同。
本发明的婴儿配方可以以液体的形式存在，或者以喂养前需用水稀释的喂养液或浓缩液的形式存在，或者以使用前需要用水重建的粉末形式存在。
本发明的婴儿配方可以如下制备：将合适量的乳清蛋白浓缩物与脱脂乳、乳糖、植物油和脂溶性维生素在去离子水中进行混合。优选地，将足够量的这些材料混合在一起，以获得约240克/升的最终浓度。然后，在高温/快速巴氏灭菌步骤前，可以向混合物中加入无机盐。合适的无机盐包括氯化钙、磷酸钙、柠檬酸钠、氢氧化钾、碳酸氢钾、硫酸亚铁、硫酸锌、氯化钠、硫酸铜、碘化钾、***钠等。然后，将混合物搅匀并冷却。然后，可以向混合物中加入热不稳定的维生素和微量营养素。然后，用水将混合物标准化，使最终的总固体浓度为每升约150-约160克，优选为每升约155克，其相当于每升约820千卡的能量。可以使用常规的超高温方法对配方进行灭菌，然后无菌地装入到合适的包装中。或者，可以将配方填充到玻璃瓶中，然后再进行灭菌。
本领域熟练技术人员可以知道，在制备本发明的婴儿配方的过程中，可以使用其它已知的制备方法和灭菌方法。本发明的婴儿配方还可以被制备成浓缩的液体产品，在给婴儿喂食前，其需要用等体积的水进行稀释。此外，可以对这样的一种婴儿配方进行脱水，例如在喷雾干燥器中，生成一种稳定的婴儿配方粉末，粉末配方能提供稳定性和运输经济的优点，所述的粉末在给婴儿喂食前需要用水进行重建。
实施例
实施例1
进行一项研究以确定在从新生早产婴儿的母亲那里收集的母乳中核苷酸的总浓度和单个核苷酸的浓度。该研究是一种预期的、非随机化的公开研究。二十七位母亲提供体积大于或等于20ml的乳汁样品。
该研究的选择标准如下：18-40岁数的门诊健康妇女；产次小于5次；泌乳；并且在产后第4-18天之间收集乳汁。该研究的母亲为胎龄在26-32周之间的婴儿的母亲，该婴儿具有合适的胎龄，并且出生时的体重小于1800克。
分析早产人乳样品的游离核苷，以及分析与碱性磷酸酶一起培育后的游离核苷。在酶处理后，游离核苷的增加表示基于摩尔的单体核苷酸的含量。下表1中的浓度用等当量的单磷酸盐来表示。
这种分析的结果在表1中给出：
表1
| 范围(mg/L) | 平均(mg/L) | |
| CMP | 0.46-14.48 | 5.3 |
| UMP | 0.29-6.65 | 3.0 |
| GMP | 0.87-10.16 | 4.8 |
| IMP | 0.00-1.35 | 0.1 |
| AMP | 1.82-8.55 | 4.1 |
| 总的单体核苷酸 | 3.44-41.19 | 17.3 |
实施例2
下面阐述本发明婴儿配方的一个例子。
以下面的方式，制备一批典型的4,000L液体婴儿配方混合物，其可以直接喂给婴儿。
通过混合86.5kg的Betapol(Loders Croklaan)、36.1L的高油酸向日葵油或红花油、8.94L的豆油、24.7kg的中链甘油三酯、1.36kg的大豆卵磷脂、2.47kg的油(该油中38％的脂肪酸是二十碳四烯酸)(ARASCO，Martek，Columbia，MD)和1.65kg的油(该油中38％的脂肪酸是二十二碳六烯酸)(DHASCO，Martek，Columbia，MD)，制备一种脂肪混合物。
然后，将脂溶性维生素、维生素A(维生素A棕榈酸酯)、β-胡萝卜素、维生素D(胆钙化醇)、维生素E(dl-α-生育酚乙酸酯)和维生素K(植物甲萘醌)分散在该脂肪混合物中。
在已经加入了溶于热水中的3620g柠檬酸钠和1590g碳酸氢钾的混合罐中，将一定量的足以提供44kg的蛋白质的加热的液体脱脂奶或脱脂奶粉加入温热的去离子水中。然后将该脂肪混合物计量到混合罐中。通过一个粉末漏斗排放管加入主要的干组分、乳糖、乳清蛋白浓缩物和麦芽糖糊精。乳清蛋白的加入量随它的蛋白质含量而变化，并足以获得44kg的蛋白质。将溶于热水中的221g牛磺酸加入到混合罐中。将下列矿物质分别溶解或分散在热水中，然后在剧烈搅拌下加入到混合罐中：2220g磷酸钙；1710g氯化钙；512g氯化钠；643g氢氧化钾；153g硫酸亚铁；72.5g碘化钾，在乳糖中的1％研磨物；359g的44.6％的硫酸锌溶液；598g的2.5％的硫酸铜溶液；以及7.22g的在碳酸氢钾中的0.3％***钠研磨物。
将混合物加热到96±2℃，在该温度保持30秒，然后冷却到66±2℃。然后，在一个两级均质器中将混合物均质，第一级为2500psig，第二级为500psig。然后，使用板式换热器将均质的混合物冷却到5-10℃。
分析混合物样品的脂肪、pH和总固形物。根据需要，加入合适量的去离子水，以便获得80％的总稀释度，并将该批料混合。取样分析总固形物和pH值。计算最终稀释度所需的水量。在将核苷酸和水溶性维生素加入到混合物之前，用这种稀释水的一部分来稀释它们。将下列核苷酸溶于温水中，然后加入到混合物中：31.7g胞苷5′单磷酸酯；27.9g腺苷5′单磷酸酯；29.7g尿苷5′单磷酸酯二钠盐；5.43g肌苷5′单磷酸酯二钠盐；以及22.4g鸟苷5′单磷酸酯二钠盐。
将水溶性维生素溶于温水中并如下加入到混合物中：将109g烟酰胺；42.3g泛酸钙；8.98g盐酸硫胺；3.55g核黄素；5.8g Pyrodoxine盐酸盐；2.51g叶酸；0.113g D生物素；7.24g氰基钴胺素和104g肌醇溶于水中并加入到混合物中。将1180g抗坏血酸溶于温水中，向其中缓慢地加入535g碳酸氢钾以中和该抗坏血酸。然后将中性的抗坏血酸溶液加入到该混合物中。将106g柠檬酸溶于温水中并加入到该混合物中。将该混合物搅拌30分钟。将该混合物标准化为每升约123g总固形物。
在开始均化二十小时后，再次将混合物均质，通过Stork UHT(超高温)灭菌处理***进行灭菌，然后填充到100ml的玻璃瓶中。
然后，将玻璃瓶在Barriquand旋转灭菌器中进行蒸汽灭菌。
这种配方的组分如下：
| 组分 | 单位 | /100ml | /100kcal |
| 蛋白质脂肪碳水化合物亚油酸能量维生素A维生素D3维生素E维生素K1维生素B1维生素B2维生素B6维生素B12烟酸(NE)叶酸泛酸 | gggmgkcalmcgmcgmgmcgmcgmcgmcgmcgmcgmcgmcg | 2.04.48.655082901.51.28120200720.382048450 | 2.445.3710.56711001101.81.59.76146244880.37100059549 |
| 生物素维生素C钙磷镁铁锌锰铜碘钠钾氯胆碱肌醇牛磺酸CMPUMPGMPIMPAMP | mcgmgmgmgmgmgmgmcgmcgmcgmgmgmgmgmgmgmgmgmgmgmg | 2.4118042.580.80.81082.510358560154.54.80.70.50.40.10.6 | 2.913.497.651.89.760.980.9812.2010112.242.710473.218.35.495.90.90.60.50.120.7 |
实施例3
根据实施例2所述的方法制备本发明的下列婴儿配方.
| 组分 | 单位 | /100ml | /100kcal |
| 蛋白质脂肪碳水化合物亚油酸 | gggmg | 2.204.238.62550 | 2.705.2010.6677 |
| 能量维生素A维生素D3维生素E维生素K1维生素B1维生素B2维生素B6维生素B12烟酸(NE)叶酸泛酸生物素维生素C钙磷镁铁锌锰铜碘钠钾氯硒胆碱肌醇牛磺酸 | kcalmcgmcgmgmcgmcgmcgmcgmcgmcgmcgmcgmcgmgmgmgmgmgmgmcgmcgmcgmgmgmgmcgmgmgmg | 81.32243.484.096.11422031220.33235340.610163.2514.6102618.10.810.814.1912440.68173.21.7113.030.084.80 | 1002754.285.037.51752501500.41287050.012504.0018.012575.010.01.001.005.011230.050.010090.02.1016.037.005.90 |
| CMPUMPGMPIMPAMP | mgmgmgmgmg | 0.70.50.40.10.6 | 0.90.60.50.120.7 |
在不脱离本发明的精神和基本性质的情况下，本发明可以包括其它具体形式，因此本发明的范围应依据所附的权利要求书，而不是上述说明书。
Claims (4)
1.适用于早产或低出生体重婴儿的婴儿配方组合物，含有4.2mg/L-11.6mg/L的CMP；2.4mg/L-8.3mg/L的UMP；2.4mg/L-6.0mg/L的GMP；0.1mg/L-1.7mg/L的IMP；以及3.3mg/L-9.9mg/L的AMP。
2.权利要求1的婴儿配方组合物，含有5.3mg/L-7.7mg/L的CMP；3.0mg/L-5.5mg/L的UMP；3.0mg/L-4.0mg/L的GMP；0.1mg/L-1.1mg/L的IMP；以及4.1mg/L-6.6mg/L的AMP。
3.权利要求1的婴儿配方组合物，其核苷酸的总浓度为12.4mg/L-37.4mg/L。
4.权利要求3的婴儿配方组合物，其核苷酸的总浓度为15.5mg/L-24.9mg/L。
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| CN103260419B (zh) | 2010-11-02 | 2014-12-24 | 雅培制药有限公司 | 稳定的浓缩液体母乳强化剂 |
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| RU2694314C1 (ru) * | 2013-12-12 | 2019-07-11 | Нестек С.А. | Искусственные питательные композиции, особенно адаптированные для младенцев и детей младшего возраста мужского и женского пола |
| CN105982074A (zh) * | 2015-03-06 | 2016-10-05 | 内蒙古伊利实业集团股份有限公司 | 核苷酸组合物及其在食品中的应用 |
| CN106259953B (zh) * | 2015-06-01 | 2019-01-29 | 内蒙古伊利实业集团股份有限公司 | 含有核苷酸的母乳化0-12月婴儿配方奶粉及其制备方法 |
| CN105053204A (zh) * | 2015-07-24 | 2015-11-18 | 林晓萍 | 促进早产儿骨骼生长发育的早产儿奶粉服用方法 |
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| PL376378A1 (en) | 2005-12-27 |
| NO329586B1 (no) | 2010-11-15 |
| DE60325748D1 (de) | 2009-02-26 |
| CA2500564C (en) | 2011-05-03 |
| HK1076583A1 (en) | 2006-01-20 |
| DK1549158T3 (da) | 2009-04-14 |
| EP1549158A1 (en) | 2005-07-06 |
| BR0315152A (pt) | 2005-08-16 |
| IL167869A (en) | 2009-09-01 |
| AU2010203123B2 (en) | 2012-03-29 |
| CN1703152A (zh) | 2005-11-30 |
| ATE419759T1 (de) | 2009-01-15 |
| US20050058690A1 (en) | 2005-03-17 |
| PT1549158E (pt) | 2009-03-05 |
| CA2500564A1 (en) | 2004-04-22 |
| NO20051650L (no) | 2005-05-06 |
| WO2004032651A1 (en) | 2004-04-22 |
| CY1110226T1 (el) | 2015-01-14 |
| ES2318172T3 (es) | 2009-05-01 |
| ECSP055724A (es) | 2005-07-06 |
| AU2003279193A1 (en) | 2004-05-04 |
| OA13141A (en) | 2006-12-13 |
| AU2010203123A1 (en) | 2010-08-12 |
| EP2050345A1 (en) | 2009-04-22 |
| NZ539849A (en) | 2006-04-28 |
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