CN1400870A - 改善的儿科配方和用于提供营养和提高耐受性的方法 - Google Patents
改善的儿科配方和用于提供营养和提高耐受性的方法 Download PDFInfo
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- CN1400870A CN1400870A CN01804563A CN01804563A CN1400870A CN 1400870 A CN1400870 A CN 1400870A CN 01804563 A CN01804563 A CN 01804563A CN 01804563 A CN01804563 A CN 01804563A CN 1400870 A CN1400870 A CN 1400870A
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Abstract
本发明提供了一种改善的儿科配方和用于给病儿提供营养和提高病儿耐受性的方法。该配方可以是粉末、浓缩物或即食的形式。该儿科配方基于100kcal含有约8至约16g的碳水化合物类(优选约9.4至约12.3g),约3至约6g脂类(优选约4.7至约5.6g),约1.8至约3.3g蛋白质(优选约2.4至约3.3g)和含约37至约370mg(优选约74至约222mg,更优选约111至约148mg)黄原胶的耐受性改进剂。该配方也可以是粉末形式的,基于100g粉末,含有约30至约90g的碳水化合物类(优选约48至约59g),约15至约30g脂类(优选约22至约28g),约8至约17g蛋白质(优选约11至约17g)和约188至约1880mg(优选约375至约1125mg,更优选约375至约1125mg)黄原胶。该配方优选还含有维生素和矿物质,且还可以含有稳定剂。该方法包括服用有效量的根据本发明如上所述的儿科配方。
Description
技术领域
本发明涉及一种儿科配方,且特别是涉及增强服用了该处方的病儿的耐受性。病儿包括婴儿(12个月或以下的儿童)和儿童(大于12个月但小于13岁的儿童),(因此,所有的婴儿都是儿童,但不是所有的儿童都是婴儿)。更具体地说,本发明涉及含有黄原胶的儿科配方,已经发现在病儿服用该处方后有效地提高了耐受性。本发明也涉及一种提供营养的方法,和涉及提高耐受性的方法,所述的方法包括服用含有黄原胶的有效量的儿科配方。
背景技术
儿科配方基于蛋白质的种类被分成三种基本类型:完整蛋白质基、水解蛋白质基和游离氨基酸基。(儿科配方包括婴儿配方和用于一岁以上儿童的配方。)市售的儿科配方除了蛋白质源以外,还可以含有碳水化合物类、脂类、维生素和矿物质。游离氨基酸目前被用作儿科配方(EleCareTM,Abbott Laboratories的Ross ProductsDivision)中的儿科来源,所述的儿科配方用于具有下述一种或更多种问题的一岁或以上的儿童,这些问题包括:消化和吸收常规食品的问题、严重的食物过敏、胃肠道问题或所需的要素膳食的其它条件。
许多病儿对某种配方表现出不耐性(配方不耐性)。该术语不耐性和配方不耐性在本文中可交替采用。不耐性是与反应有关的非免疫系统,且可以通过行为或粪便或进食方式的改变,例如与对配方耐受性良好的正常婴儿相比,由吐出或呕吐的增加、大量粪便的增加、更呈水样的粪便和更为烦躁来得到证实。不耐性更通常是通过胃肠症状(例如,呕吐、粪便式样和产气)以及行为特点(例如,对配方的接受,烦躁和哭闹)来得到证实。在临床研究背景中,这样的行为使父母不愿意其婴儿参与特定的研究。由于这样的行为不参与研究的婴儿被认为是有不耐性。在非临床研究背景下,这样的行为经常使父母改变配方。
不耐性与一些婴儿对某种配方的过敏类型反应形成对照。这些过敏类型反应与免疫系统相关,且是由婴儿对配方中存在的蛋白质敏感而引起的。许多婴儿显示出对完整(全)蛋白质过敏或敏感,例如对在完整的牛奶蛋白质中或完整的分离大豆蛋白质基的配方中的那些过敏或敏感,而这些婴儿对大量的水解蛋白质具有耐受性。(水解物配方(也称作半要素配方)含有已经水解的蛋白质或蛋白质被分解为短肽片段和氨基酸,结果更易于被所有婴儿消化。)这些与过敏或敏感相关的免疫系统经常导致皮肤感染、呼吸的或胃肠的症状例如呕吐和腹泻。显示对完整蛋白质配方反应的婴儿经常不对水解物配方反应,因为其免疫系统不将水解蛋白质作为完整蛋白质,而完整的蛋白质引起了这些症状。显示出对配方反应相关的免疫系统的婴儿也显示出对反应相关的非免疫系统(配方不耐性),如前所述。
已经有了许多不同的儿科配方。该领域的现有技术着眼点主要在于配方的物理稳定性,并涉及加工和制备。
Masson的US5192577公开并教导了黄原胶在营养配方中的用途,但黄原胶只是作为稳定剂,并明确限定其用于将κ-角叉菜胶与黄原胶相结合的配方。Masson主要解决所公开的营养配方的物理稳定性问题,并没有指出通过病人服用该配方而显示出不耐性的问题。
Smidt等人的US5472952涉及营养完全食品组合物,该组合物含有部分水解的果胶,用于腹泻的处理。其中公开了黄原胶作为乳化剂或稳定剂的用途,并没有提供有关黄原胶数量的教导。
Antinone等人的US5681600公开了黄原胶在营养配方中的用途,但如此使用黄原胶的教导是不能接受的,因为使用含有黄原胶的配方产生了不能接受的钙输送。
Mahmoud的US4670268公开了一种肠内营养低变应原的营养配方,该配方含有作为稳定剂的黄原胶,但没有提供用于此目的的黄原胶有效量的任何教导。
Montezinos的US5919512公开了在风味剂/混浊乳液中黄原胶作为稳定剂的用途,例如用于稀释的果汁和茶饮料。所公开的乳液不含蛋白质,且因此对用于儿科配方是不能令人满意的。
DeWille等人的US5597595公开了用钙和维生素D强化的低pH饮料中黄原胶作为乳液稳定剂的用途。
DeWille等人的US5817351公开了钙强化的低pH饮料中黄原胶作为稳定剂的用途。所公开的饮料不含脂肪和蛋白质,且不适合作为完全的营养源。
Chandler等人的US5609897公开了在软饮料类的饮料粉中黄原胶的用途,所述的饮料粉已经用钙和维生素D强化。
Crank等人的US5858449公开了富异黄酮大豆基冷冻甜食中黄原胶的用途。
总之现有技术的营养配方完全没有涉及不耐性的问题。因此,就有了对显示出不耐性症状的病儿更易于耐受的配方的还未解决的需求。耐受较好的配方所导致的行为更类似于对配方耐受良好的正常病儿所显示出来的行为。
发明概述
本发明提供了一种改善的儿科配方和用于提供营养和提高儿童服用配方耐受性的方法。(如本文所使用的术语儿童包括婴儿和大于1岁的儿童,除非特别指出。术语儿童和病儿也可交换使用)。使用黄原胶对耐受性带来了意想不到的改善。该配方可以是液体浓缩物、即食或粉末的形式。该配方基于100kcal含有约8至约16g的碳水化合物类(优选约9.4至约12.3g),约3至约6g脂类(优选约4.7至约5.6g),约1.8至约3.3g蛋白质(优选约2.4至约3.3g)和含约37至约370mg(优选约74至约222mg,更优选约111至约148mg)黄原胶的耐受性改进剂。如果该配方是粉末形式则基于100g粉末,含有约30至约90g的碳水化合物类(优选约48至约59g),约15至约30g脂类(优选约20至约30g),约8至约17g蛋白质(优选约10至约17g)和含约188至约1880mg(优选约375至约1125mg,更优选约565至约750mg)黄原胶。
该配方还含有稳定剂且还优选含足够量的维生素和矿物质,用以提供婴儿或超过1岁儿童所需要的日常营养。当该配方是婴儿配方时,维生素和矿物质的量优选根据FDA指标选择。当婴儿服用本发明的配方时,与服用同样组成但缺乏耐受性改进剂的配方的婴儿相比,这些婴儿显示出提高了的耐受性。
本发明还提供了用于提供营养和改善病儿耐受性的方法。该方法包括给儿童服用有效量的一种配方,该配方基于100kcal含有约8至约16g的碳水化合物类(优选约9.4至约12.3g),约3至约6g脂类(优选约4.7至约5.6g),约1.8至约3.3g蛋白质(优选约2.4至约3.3g)和含约37至约370mg(优选约74至约222mg,更优选约111至约148mg)黄原胶的耐受性改进剂。如果该配方是粉末形式则基于100g粉末,含有约30至约90g的碳水化合物类(优选约48至约59g),约15至约30g脂类(优选约20至约28g),约8至约17g蛋白质(优选约11至约17g)和含约188至约1880mg(优选约375至约1125mg,更优选约565至约750mg)黄原胶。服用了本发明配方的儿童比服用同样的但缺乏黄原胶耐受性改进剂的配方的儿童显示出更少的不耐性症状。
本发明的详细说明
本发明提供了一种改善的儿科配方,服用了该配方的儿童降低了不耐性。本发明还提供了用于提供营养和提高病儿耐受性的方法,该方法包括服用本发明的配方。使用黄原胶给耐受性带来了意想不到的改善效果。
婴儿不耐性(配方不耐性)通常通过胃肠症状(例如呕吐、粪便形状和产气)以及行为特点(例如,对配方的接受、烦躁和哭闹)显示出来。对于本发明的目的,改善的耐受性(或降低的耐受性)由下述症状或特点的一种或多种的改善(朝着正常方式转变)来确定:粪便形状、呕吐、吐出、配方的接受、烦躁、哭闹或有不耐性(临床背景)。
本发明的儿科配方可以是粉末的,液体浓缩物或即食的形式。在服用之前,对粉末和浓缩物形式的配方加水。在第一个实施方案中,本发明的儿科配方基于100kcal含有约8至约16g的碳水化合物类(优选约9.4至约12.3g),约3至约6g脂类(优选约4.7至约5.6g),约1.8至约3.3g蛋白质(优选约2.4至约3.3g)和含约37至约370mg(优选约74至约222mg,更优选约111至约148mg)黄原胶的耐受性改进剂。如果该配方是粉末形式则基于100g粉末,含有约30至约90g的碳水化合物类(优选约48至约59g),约15至约30g脂类(优选约22至约28g),约8至约17g蛋白质(优选约11至约17g)和含约188至约1880mg(优选约375至约1125mg,更优选约565至约750mg)黄原胶。根据本发明的配方的碳水化合物类、脂类和蛋白质范围(基于每100kcal、每100g粉末和每L(如服用浓缩物))列于表I中。
黄原胶是通过
田野黄单胞菌的碳水化合物发酵产生的高分子量多糖。而黄原胶具有各种粒径,在本发明中使用的黄原胶并不限于任何特定的粒径。基于加工参数选择合适的粒径,例如如果黄原胶是被干混进配方中,则较细的粒径(200目)是优选的,而如果黄原胶不是干混进配方中,则优选更粗的粒径(80目)。用于本发明合适的黄原胶是源自Illinois,Chicago的Monsanto部Kelco的Keltrol F黄原胶(200目)。
合适的碳水化合物类、脂类和蛋白质可以是非常广泛的,并且是制备儿科配方技术领域的普通技术人员所公知的。由此合适的碳水化合物类包括,但不仅限于水解的、完整的、天然的和/或化学变性淀粉,所述淀粉源自糯性或非糯性的玉米、木薯、大米或马铃薯;和糖例如葡萄糖、果糖、乳糖、蔗糖、麦芽糖、高果玉米糖浆和其混合物。麦芽糖糊精是由酸或酶对例如玉米或大米之类的淀粉水解获得的多糖。其分类基于水解的程度,且报导为右旋糖当量(DE)。当蛋白质水解产物是蛋白质源时,任何麦芽糖糊精的DE优选采用小于约18-20。当蛋白质水解产物是蛋白质源时,也同样优选避免导致过多的美拉德褐变产品的形成。
合适的脂类包括但不仅限于椰子油、豆油、玉米油、橄榄油、红花油、高油酸红花油、MCT油(中链甘油三酸酯)、向日葵油、高油酸向日葵油、棕榈油、卡诺拉(canola)油、花生四烯酸和二十二碳六烯酸的脂类源和其混合物。花生四烯酸和二十二碳六烯酸的脂类源包括但不仅限于船用油、蛋黄油和真菌油。
合适的蛋白质源包括乳、大豆、大米、肉(例如,牛肉)、动物和植物(例如,豌豆、马铃薯)、蛋(卵清蛋白)、明胶和鱼。合适的完整蛋白质包括但不仅限于大豆基、乳基、酪蛋白、乳清蛋白、米蛋白、牛肉胶原、豌豆蛋白、马铃薯蛋白和其混合物。合适的水解蛋白包括但不仅限于水解大豆蛋白、水解酪蛋白、水解乳清蛋白、水解大米蛋白、水解马铃薯蛋白、水解鱼蛋白、水解卵清蛋白、水解明胶蛋白,水解动物和植物蛋白的组合和其混合物。水解蛋白质(蛋白质水解产物)是已经被水解的蛋白质或蛋白质被分解成较短的肽片段和氨基酸。这样的水解肽片段和游离氨基酸更易于消化。在最宽的意义中,当一个或多个酰胺键已被打断时,蛋白质就被水解。在制备过程中酰胺键被无意或偶然性的断开,例如由于加热或剪切。对于本发明,术语水解蛋白指的是以断开酰胺健的方式被加工或处理的蛋白质。可以进行有意的水解,例如通过用酶或酸处理完整蛋白质。优选用于本发明配方的水解蛋白质被水解到这样一种程度:氨基氮(AN)与总氮(TN)之间的比值是约0.1AN比1.0TN至约0.4AN比约1.0TN,优选约0.25AN比1.0TN至约0.4AN比约1.0TN。(提供的AN∶TN比只是针对水解蛋白质源的,并不表示在最终的儿科营养配方产品中的AN∶TN比,由于游离氨基酸可以补充物的形式添加,并将改变所报告的值。)蛋白质也可以是游离氨基酸的形式。本发明的配方优选以各种氨基酸的形式补充,以便于提供营养更完全和平衡的配方。合适的游离氨基酸的实例包括,但不仅限于色氨酸、酪氨酸、胱氨酸、牛磺酸、L-蛋氨酸、L-精氨酸和肉毒碱。
本发明的配方优选也含有设计量的维生素和矿物质,以提供病儿日常所需的营养。该配方优选包括但不仅限于下述维生素和矿物质:钙、磷、钠、氯、镁、锰、铁、铜、锌、硒、碘和维生素A、E、C、D、K和复合维生素B。另外,对于婴儿配方的营养指导描述于婴儿配方法(Infant Formula Act),21U.S.C.节350(a)。在婴儿配方法中的营养指导随着有关婴儿营养需求的进一步研究的完善而继续得到修整。本发明包括的配方中含有的维生素和矿物质可能目前没有列在该法中。
在本发明第二个实施方案中,本发明配方还含有稳定剂。用于儿科营养配方的合适的稳定剂是本领域普通技术人员所公知的。合适的稳定剂包括但不仅限于阿拉伯树胶、阔叶榆绿木胶、刺梧桐胶、黄芪胶、琼脂、丹麦琼脂、瓜尔豆胶、吉兰糖胶、槐树豆胶、果胶、低甲氧基果胶、明胶、微晶纤维素、CMC(羧甲基纤维素钠)、甲基纤维素羟丙基甲基纤维素、羟丙基纤维素、DATEM(甘油一酸酯和甘油二酸酯的二乙酰酒石酸酯)、葡萄聚糖、角叉菜胶和其混合物。本发明配方优选无κ-角叉菜胶作为稳定剂,且最优选无角叉菜胶。一种配方如果主要采用另一种形式(ι或λ)的任何角叉菜胶的话,则被定义为无κ-角叉菜胶。对于本发明,无κ-角叉菜胶或角叉菜胶是指在制备期间没有添加κ-角叉菜胶或角叉菜胶。稳定剂的用量根据所选定的稳定剂、其它含有的成分和所寻求的配方的稳定性和粘度是不同的。本领域普通技术人员基于配方中所寻求的特定的性质(例如,粘度)可以确定适合的量。
本发明还提供了用于提供营养和改善病儿耐受性的方法。该方法包括给儿童服用有效量的一种配方,该配方基于100kcal含有约8至约16g的碳水化合物类(优选约9.4至约12.3g),约3至约6g脂类(优选约4.7至约5.6g),约1.8至约3.3g蛋白质(优选约2.4至约3.3g)和含约37至约370mg(优选约74至约222mg,更优选约111至约148mg)黄原胶的耐受性改进剂。如果该配方是粉末形式则基于100g粉末,含有约30至约90g的碳水化合物类(优选约48至约59g),约15至约30g脂肪(优选约22至约28g),约8至约17g蛋白质(优选约11至约17g)和含约188至约1880mg(优选约375至约1125mg,更优选约565至约750mg)黄原胶。
在另一个实施方案中,该配方还含有稳定剂。该实施方案也优选含有维生素和矿物质,其量如上所述。合适的碳水化合物类、脂类、蛋白质和稳定剂是本领域技术人员所公知的,包括但不仅限于上述物质。优选,如果该配方是婴儿配方,则该方法包括服用足够量的该配方,以满足婴儿日常所需的所有营养。
本发明的儿科配方可以采用本领域技术人员公知的那些技术制备。有多种技术用于生产粉末的、即食的和浓缩液体配方。一般,这些技术包括源自一种或多种溶液的浆液的形成,所述的溶液含有水和一种或多种下述成分:碳水化合物类、蛋白质、脂类、稳定剂、维生素和矿物质。该浆液是被乳化的、均质的和冷却的。在加工之前,之后或这两个时间内可以向该浆液添加各种其它的溶液。该加工的配方接着被灭菌,并可以被稀释成用于即食成分或以浓缩液体或粉末贮藏。如果得到的配方是即食液体或浓缩液体,则在消毒之前添加合适量的水。如果得到的配方是粉末,则浆液被加热和干燥以获得粉末。由干燥产生的粉末,可以与如果需要的其它成分干混。
以下实施例是对用于改善病儿耐受性的本发明的方法和组合物进行举例说明。虽然在以下实施例中本发明对婴儿营养配方粉进行了说明,并不意味着是限制,因为它还包括即食和浓缩的液体婴儿配方,以及用于一岁或以上儿童的配方。该实施例也没有对使用的其它的碳水化合物类、脂类、蛋白质、稳定剂、维生素和矿物质进行限制,且并没有脱离本发明的范围。实施例1-临床研究
以下对耐受性的临床研究的结果进行概述,其中婴儿服用四种不同配方中的一种。采用本发明三种不同的配方和一种对照配方(除了缺乏黄原胶耐受性改进剂以外完全相同)。对健康的、满月、28天或更小的婴儿进行屏蔽的、随机的、平行的耐受性研究。给婴儿服用销售标签是Alimentum-含铁的水解蛋白配方(Abbott Laboratories的RossProducts Division)的即食组合物,以一周为基准。之后,即刻随机服用对照配方或配方B、C或D中的一种。对照配方组合物与配方B-D相同,只是配方B-D中含有不同量的黄原胶。所有四种配方组合物列于表II和表IIA中。该对照和配方B-D以粉末的形式被放置在足够大小的金属罐中,当复水时使其含有350g。
用于研究的婴儿如果他们被判定为健康状况良好、满足37至42周的孕期;出生重量大于2500g、至少有28天大,在研究期间没有服用其它配方、其父母自愿在告知的同意表格上签字、其父母同意不服用矿物质或维生素添加剂、其父母同意在研究期间只给他们的婴儿服用研究配方、是单独的怀孕生产、没有母系病史,所述的病史对胎儿有负面影响例如是糖尿病、肺结核、产期感染或物质滥用;没有显示出心脏疾病、呼吸系统疾病、胃肠疾病、血液疾病或新陈代谢疾病的迹象;且出生的重量不大于患有孕期糖尿病的母亲所生婴儿的95%(NCHS(国家健康统计中心(National Center for HealthStatistics)))则是合格的。
通过当地审查人员对婴儿的识别,合格的婴儿被招收进来。来自三个不同地点的总共182名婴儿参与进研究中。在最初的182人中,在基准期有45人退出,并未服用对照配方或配方B-D。在137名接受对照配方或配方B-D之一的婴儿中,有12名没有完成研究。
研究的第一天被确定为开始研究的那一天。在第一天,收集人口统计/注册数据,且婴儿被脱去衣服称重。父母们接受约12罐32-液盎司即食组合物形式的基准Alimentum含铁水解蛋白配方。父母们被指导连续以其目前的配方进行喂养直至第一天下午6:00,且接着在第一天下午6:00之后开始首次喂养基准配方。在第一天下午6:00开始收集摄取量和粪便数据,且在第7天下午5:59结束。父母们也应记录下其婴儿粪便的特点、每次喂养消耗配方的体积和吐出和呕吐的发生数量。
在研究的第8天,研究人员对父母们的完整记录进行完整而准确的复审,对婴儿进行再次称重,并由父母们对有关配方的满意度和喂养,以及粪便的形式的调查表进行完整的填写。父母们返还未使用的基准配方,并被提供了约4罐指定的配方即对照配方、配方B、C和D中的一种。父母们被指导连续喂养基准配方直至第8天下午6:00,之后开始喂养指定的配方,并记录喂养和粪便的信息。在第8天下午6:00开始收集摄取量和粪便数据,且在第14天下午5:59结束。对对照配方和配方B-D收集6天的数据。与基准喂养一样,在第8天至第14天由父母们完整记录的膳食摄取和粪便情况,在第15天由视察的研究人员复审。在第15天,对婴儿进行称重,填写调查表,父母们返还任何未使用的配方。统计分析
主要的可变参数是平均日排便次数,粪便平均稠度等级和呕吐和吐出的发生数量。首先的分析由基于有意处理的主要结果变量的分析组成。其次的分析由完成研究的人员进行。研究期间的数据使用位点作为块因子的单向方差分析进行分析。另外,进行用研究期间的数据作为响应值和基准数据作为协方差的协方差分析,作为确证分析。当适当的时候,使用变化(平方根的排列反正弦)。使用列联表方法对分类数据/顺序数据进行分析。所有的测试都是双边的,且在0.05显著水平下进行。在三个主要分析中的显著水平对于测试的多重性使用Holm下降Bonferroni方法进行调节。结果
在研究的第一天,在种族或年龄方面没有观察到明显的统计差异。在参与的组中性别分布方面观察到了明显的差异。(P<0.05)。在第一天喂养配方B的组与喂养对照配方的组相比,重量明显的大。由于不耐性服用对照配方的婴儿与服用配方B、C或D(含黄原胶耐受性改进剂的配方)的相比,退出的婴儿数量明显的多。
在日平均粪便数量方面,各组中观察到了显著的统计差异(P=0.003用于多重性的调节)。服用对照配方的婴儿排便数量明显多于服用配方B(P=0.0001)和配方D(P=0.0073)的婴儿。在实验期(8-14天),服用对照配方的婴儿每天平均排便数2.7±0.2,而服用配方B和D的婴儿每天平均排便数是1.6±0.2和2.1±0.3。在粪便平均稠度等级方面,各组中没有明显的统计差异。在各组中水样粪便的百分数明显不同。当在分析中将基准测量附加为协方差时,服用对照配方的婴儿其水样粪便与配方C和D组相比更多(P<0.01)。对于其它粪便参数(松散/浓粥状的、软、成形的)各组中没有观察到其它显著的差异。有关日排便数量、粪便平均稠度等级、水样、松散/浓粥状的粪便、软粪便和成形的粪便的结果列于表III中。
在伴有吐出或呕吐的喂养的百分数方面,各组中没有观察到显著的统计差异。在每日喂养数量、每日摄取m1数,或每日每kg摄取的m1数,在各组中没有观察到显著的不同。有关吐出、呕吐、每日喂养数量、每天摄取ml数,和每日每kg摄取的m1数的结果列于表IV中。
在第15天在重量NCHS Z-分数方面,或在实验期内(8-14天)增重方面各组中没有观察到显著的差别。在视察的第15天婴儿的重量方面各组中观察到显著的差异。在第一天喂养配方B的婴儿比喂养对照配方的婴儿体重更重(P<0.01)。当将第8天的重量用作协方差时,在研究结束时的重量方面,各组中没有观察到显著的差别。结果列于表V中。讨论
研究的结果证实向配方中添加黄原胶改善了服用这样的配方婴儿的耐受性。服用配方B、C和D的婴儿(具有黄原胶耐受性改善剂)普遍比服用对照配方(表II)的婴儿每日排便数更少。确定的结果表明由父母们裁定的服用配方B、C和D的婴儿与服用对照配方的婴儿相比具有多粪便的天数较少。另外,在服用配方B、C和D的组中由于配方不耐性使婴儿退出的数量比服用对照配方的组的数量明显的少。结果显示在表VI中。服用对照配方的组,即没有耐受性改进剂,退出的百分数是22%。因此,对于服用配方B、C和D的婴儿临床退出与对照相比,退出数量降低了(0-6%)。而参与该研究的婴儿是健康的婴儿(没有对完整蛋白质公知的过敏或敏感),对完整蛋白质过敏或敏感的婴儿和大于1岁显示出不耐性症状的儿童也可以实现耐受性改善,所述的对完整蛋白质过敏或敏感的婴儿对目前水解产物配方显示出不耐性的症状。实施例2
通过将约68701b.玉米麦芽糖糊精、30951b.蔗糖、24.4kg氯化镁、54.9kg柠檬酸钾、17.8kg氯化钠、114.5kg磷酸钙(三元)、25.5kg碳酸钙、16.4kg氯化钾和13.7g碘化钾溶于160°F的水中,制成水溶液,从而制备粉末配方。对于使用的特定的制造设备,用于制备水溶液的水量应进行优化。该溶液与第二种溶液混合形成浆液,所述的第二溶液含19111b.MCT油、130.6kg甘油一酸酯和甘油二酸酯的二乙酰酒石酸酯、26.1kg甘油一酸酯和甘油二酸酯、20201b高油酸红花油、1.11b混合的生育酚、16131b的豆油、2.1kg棕榈酸抗坏血酸酯和3.2kg含棕榈酸维生素A、醋酸维生素E、叶绿醌和维生素D3的维生素预混合物。该浆液在68至74℃下混合30分钟至2小时。该浆液在1000psi下被乳化,通过二级均质机在2500psi/500psi下被均质,并通过板式热交换器冷却至约4℃。将含游离氨基酸、水溶维生素和微量矿物质的溶液添加到该加工的浆液中。将浆液在16秒的最小时间内被加热至74.4至85℃,并喷雾干燥以获得水分含量约1.5%的粉末。该喷雾干燥粉末与约34301b的水解酪蛋白和51.2kg的黄原胶干混。实施例3
通过将约68701b.玉米麦芽糖糊精、30951b.蔗糖、24.4kg氯化镁、54.9kg柠檬酸钾、17.8kg氯化钠、114.5kg磷酸钙(三元)、25.5kg碳酸钙、16.4kg氯化钾和13.7g碘化钾溶于160°F的水中,制成水溶液,从而制备粉末配方。对于使用的特定的制造设备,用于制备水溶液的水量应进行优化。该溶液与第二种溶液混合形成浆液,所述的第二溶液含19111b.MCT油、130.6kg甘油一酸酯和甘油二酸酯的二乙酰酒石酸酯、26.1kg甘油一酸酯和甘油二酸酯、20201b高油酸红花油、1.11b混合的生育酚、16131b的豆油、2.1kg棕榈酸抗坏血酸酯和3.2kg含棕榈酸维生素A、醋酸维生素E、叶绿醌和维生素D3的维生素预混合物。该浆液在68至74℃下混合30分钟至2小时。该浆液在1000psi下被乳化,通过二级均质机在2500psi/500psi下被均质,并通过板式热交换器冷却至约4℃。将约34301b水解酪蛋白在水中在68-74℃下混合30分钟至2小时。该浆液在1000psi下被乳化,通过二级均质机在2500psi/500psi下被均质,并通过板式热交换器冷却至约4℃,并被添加到碳水化合物类/脂肪/脂类的混合物中。将含游离氨基酸、水溶维生素和微量矿物质的溶液添加到该加工的浆液中。将浆液在16秒的最小时间内被加热至74.4至85℃,并喷雾干燥以获得水分含量约1.5%的粉末。该喷雾干燥粉末与51.2kg的黄原胶干混。实施例4
通过将约68701b.玉米麦芽糖糊精、30951b.蔗糖、24.4kg氯化镁、54.9kg柠檬酸钾、17.8kg氯化钠、114.5kg磷酸钙(三元)、25.5kg碳酸钙、16.4kg氯化钾和13.7g碘化钾溶于160°F的水中,制成水溶液,从而制备粉末配方。对于使用的特定的制造设备,用于制备水溶液的水量应进行优化。该溶液与第二种溶液混合形成浆液,所述的第二溶液含19111b.MCT油、130.6kg甘油一酸酯和甘油二酸酯的二乙酰酒石酸酯、26.1kg甘油一酸酯和甘油二酸酯、20201b高油酸红花油、1.11b混合的生育酚、16131b的豆油、2.1kg棕榈酸抗坏血酸酯和3.2kg含棕榈酸维生素A、醋酸维生素E、叶绿醌和维生素D3的维生素预混合物。该浆液在68至74℃下混合30分钟至2小时。该浆液在1000psi下被乳化,通过二级均质机在2500psi/500psi下被均质,并通过板式热交换器冷却至约4℃。将约34301b水解酪蛋白在水中在68-74℃下混合30分钟至2小时。该浆液在1000psi下被乳化,通过二级均质机在2500psi/500psi下被均质,并通过板式热交换器冷却至约4℃,并被添加到碳水化合物类/脂肪/脂类的混合物中。将含游离氨基酸、水溶维生素和微量矿物质的溶液添加到该加工的浆液中。将浆液在16秒的最小时间内被加热至74.4至85℃,并喷雾干燥以获得水分含量约1.5%的粉末。实施例5
通过将约68701b.大米麦芽糖糊精、30951b.蔗糖、24.4kg氯化镁、54.9kg柠檬酸钾、17.8kg氯化钠、114.5kg磷酸钙(三元)、25.5kg碳酸钙、16.4kg氯化钾和13.7g碘化钾溶于160°F的水中,制成水溶液,从而制备粉末配方。该溶液与第二种溶液混合形成浆液,所述的第二溶液含19111b.MCT油、130.6kg甘油一酸酯和甘油二酸酯的二乙酰酒石酸酯、26.1kg甘油一酸酯和甘油二酸酯、20201b高油酸红花油、1.11b混合的生育酚、16131b的豆油、2.1kg棕榈酸抗坏血酸酯和3.2kg含棕榈酸维生素A、醋酸维生素E、叶绿醌和维生素D3的维生素预混合物。该浆液在68至74℃下混合30分钟至2小时。该浆液在1000psi下被乳化,通过二级均质机在2500psi/500psi下被均质,并通过板式热交换器冷却至约4℃。将含水溶维生素和微量矿物质的溶液添加到该加工的浆液中。将浆液在16秒的最小时间内被加热至74.4至85℃,并喷雾干燥以获得水分含量约1.5%的粉末。该喷雾干燥粉末与约34301b的水解酪蛋白、游离氨基酸、41.2kg槐树豆胶和51.2kg的黄原胶干混。
参照具体的实施方案本发明已经得到了详细说明,应该理解这并不是将本发明限制于所公开的具体形式。相反本发明涵盖了所有的改进和替代,而这并没有脱离本发明的实质和范围。
表1
每100kcal、每100g粉末和每L(作为喂养浓度)的
碳水化合物类、脂类和蛋白质的范围
营养素(g) | 范围 | 每100kcal | 每100g粉末 | 每L(作为喂养浓度) |
碳水化合物类 | 最宽范围 | 8-16 | 30-90 | 53-107 |
优选 | 9.4-12.3 | 48-59 | 64-83 | |
脂类 | 最宽范围 | 3-6 | 15-30 | 22-40 |
优选 | 4.7-5.6 | 22-28 | 32-38 | |
蛋白质 | 最宽范围 | 1.8-3.3 | 8-17 | 12-22 |
优选 | 2.4-3.3 | 11-17 | 16-22 |
表II
对照配方和配方B、C和D*的营养素含量
*除了基于最小的蛋白质和脂肪的最大的碳水化合物类以外,值是最小的。
营养素1 | 每L | 每100kcal | 每100g粉末 |
蛋白质(g) | 18.6 | 2.75 | 13.9 |
脂肪(g) | 37.5 | 5.55 | 28.1 |
碳水化合物类(g) | 73 | 10.8 | 54.6 |
钙(mg) | 710 | 105 | 531 |
磷(mg) | 507 | 75 | 379 |
镁(mg) | 51 | 7.5 | 38.1 |
铁(mg) | 12.2 | 1.8 | 9.1 |
锌(mg) | 5 | 0.74 | 3.7 |
锰(mcg) | 34 | 5 | 25 |
铜(mcg) | 500 | 74 | 374 |
碘(mg) | 100 | 14.8 | 75 |
钠(mg) | 297 | 43.9 | 222 |
钾(mg) | 800 | 118.3 | 598 |
氯(mg) | 541 | 80 | 405 |
硒(mcg) | 16 | 2.4 | 12 |
维生素A(IU) | 2200 | 325 | 1646 |
维生素D(IU) | 400 | 59 | 299 |
维生素E(IU) | 20.8 | 3.1 | 15.6 |
维生素K1(IU) | 101 | 14.9 | 75.5 |
维生素B-1(mcg) | 580 | 86 | 434 |
维生素B-2(mcg) | 600 | 89 | 449 |
维生素B-6(mcg) | 530 | 78 | 396 |
维生素B-12(mcg) | 3 | 0.44 | 2.24 |
烟酸(mg) | 9 | 1.33 | 6.73 |
叶酸(mcg) | 100 | 14.8 | 74.8 |
泛酸(mg) | 5 | 0.74 | 3.74 |
生物素(mg) | 30 | 4.4 | 22.4 |
维生素C(mg) | 90 | 13.3 | 67.3 |
胆碱(mg) | 53 | 7.8 | 39.6 |
肌醇(mg) | 30 | 4.4 | 22.4 |
对照配方成分:玉米麦芽糖糊精、水解酪蛋白(酶法水解和木炭处理)、蔗糖、高油酸红花油、分馏的椰子油(中链甘油三酸酯)、豆油、甘油一酸酯和甘油二酸酯的二乙酰酒石酸酯、磷酸钙、柠檬酸钾、甘油一酸酯和甘油二酸酯、碳酸钙、氯化镁、抗坏血酸、L-胱氨酸二盐酸盐、氯化钠、氯化钾、L-酪氨酸、氯化胆碱、L-色氨酸、硫酸铁、牛磺酸、间肌醇、棕榈酸抗坏血酸酯、醋酸维生素E、硫酸锌、混合生育酚、L-肉毒碱、烟酰胺、泛酸钙、硫酸铜、棕榈酸维生素A、盐酸硫胺素、维生素B-2、盐酸吡哆辛、叶酸、碘化钾、硫酸锰、叶绿醌、生物素、亚硒酸钠、维生素D3,维生素B-12。
配方B、C和D成分:玉米麦芽糖糊精、水解酪蛋白(酶法水解和木炭处理)、蔗糖、高油酸红花油、分馏的椰子油(中链甘油三酸酯)、豆油、甘油一酸酯和甘油二酸酯的二乙酰酒石酸酯、磷酸钙、柠檬酸钾、黄原胶、甘油一酸酯和甘油二酸酯、碳酸钙、氯化镁、抗坏血酸、L-胱氨酸二盐酸盐、氯化钠、氯化钾、L-酪氨酸、氯化胆碱、L-色氨酸、硫酸铁、牛磺酸、间肌醇、棕榈酸抗坏血酸酯、醋酸维生素E、硫酸锌、混合生育酚、L-肉毒碱、烟酰胺、泛酸钙、硫酸铜、棕榈酸维生素A、盐酸硫胺素、维生素B-2、盐酸吡哆辛、叶酸、碘化钾、硫酸锰、叶绿醌、生物素、亚硒酸钠、维生素D3,维生素B-12。
表IIA
在对照配方和配方B、C和D中黄原胶的量(MG)
配方 | 每升 | 每100kcal | 每100g粉末 |
A | 0 | 0 | 0 |
B | 500 | 74 | 374 |
C | 1000 | 148 | 748 |
D | 1500 | 222 | 1122 |
表III在基准期和试验期日排便数量、粪便平均稠度等级、和水样、松散/浓
粥状的粪便、软粪便和成形的粪便的百分数1
1平均±平均的标准误差。21=水样的、2=松散/浓粥状、3=软的、4=成形的、5=硬的
参数 | 组/配方 | 基准(1-7天) | 试验(1-8天) |
排便(次数/天) | 对照 | 2.7±0.2 | 2.7±0.2 |
B | 2.6±0.3 | 1.6±0.2 | |
C | 2.6±0.3 | 1.9±0.2 | |
D | 2.5±0.3 | 2.1±0.3 | |
粪便平均稠度等级2 | 对照 | 2.5±0.1 | 2.1±0.1 |
B | 2.4±0.1 | 2.0±0.1 | |
C | 2.3±0.1 | 2.3±0.1 | |
D | 2.3±0.1 | 2.3±0.1 | |
水样粪便% | 对照 | 6.9±2.3 | 29.0±6.1 |
B | 8.9±2.7 | 22.6±5.4 | |
C | 13.2±3.6 | 11.0±4.3 | |
D | 11.6±2.7 | 14.2±4.2 | |
松散/浓粥状粪便% | 对照 | 41.6±5.1 | 42.1±5.5 |
B | 47.7±5.3 | 51.9±6.3 | |
C | 49.1±5.4 | 51.3±7.2 | |
D | 52.6±4.3 | 42.6±6.2 | |
软粪便% | 对照 | 45.4±5.4 | 22.6±4.9 |
B | 38.0±5.4 | 25.4±6.3 | |
C | 31.6±5.0 | 33.8±7.5 | |
D | 31.8±4.0 | 37.0±5.8 | |
成形粪便% | 对照 | 5.7±1.9 | 6.3±3.2 |
B | 5.3±1.9 | 0.0±0.0 | |
C | 5.8±2.7 | 2.2±1.4 | |
D | 3.4±1.2 | 5.4±2.3 |
表IV在基准期和试验期每日服用次数、平均摄取、和伴随着吐出、呕吐以
及吐出和呕吐的服用百分数1
1平均±平均的标准误差。
参数 | 组/配方 | 基准(1-7天) | 试验(1-8天) |
服用次数/天 | 对照 | 7.5±0.2 | 7.3±0.3 |
B | 7.4±0.2 | 7.3±0.3 | |
C | 7.4±0.3 | 7.1±0.3 | |
D | 7.2±0.2 | 6.9±0.2 | |
平均摄取(ml/天) | 对照 | 524±19 | 568±26 |
B | 556±28 | 624±32 | |
C | 525±21 | 605±24 | |
D | 551±26 | 608±21 | |
伴随着吐出的服用% | 对照 | 11.1±2.0 | 13.3±3.5 |
B | 17.0±3.1 | 11.7±2.1 | |
C | 23.8±4.3 | 15.0±4.2 | |
D | 11.5±2.2 | 9.0±1.8 | |
具有任何呕吐的受验者% | 对照 | 8.2±2.9 | 2.0±1.0 |
B | 4.1±1.4 | 3.9±2.9 | |
C | 7.3±2.6 | 3.6±2.0 | |
D | 4.8±1.6 | 2.6±1.0 | |
伴随着吐出或呕吐的服用% | 对照 | 19.3±3.5 | 15.3±3.5 |
B | 21.0±3.8 | 15.6±3.3 | |
C | 31.2±5.1 | 18.6±4.5 | |
D | 16.3±3.2 | 11.5±2.3 |
表V
在基准期和试验期婴儿的增重1
1平均±平均的标准误差。2婴儿数量:44基准,35试验。3婴儿数量:43基准,35试验。4婴儿数量:39基准,28试验。5婴儿数量:44基准,36试验。
参数 | 组/配方 | 基准(1-7天) | 试验(8-14天) |
增重(g/天) | 对照2 | 30.2±2.7 | 31.1±2.9 |
B3 | 33.6±2.6 | 34.4±2.1 | |
C4 | 29.3±2.8 | 30.9±2.8 | |
D5 | 26.6±2.4 | 34.1±2.7 |
表VI
通过服用试验者退出的情况(n=182)
1除了1500组中一个婴儿以外,都是由于对配方不具有耐性或其父母不满意。2百分数=[早期退出(8-14天)/[成功完成者±基准退出(1-7天)]]×100
退出情况 | 配方 | |||
对照 | B | C | D | |
成功完成 | 29 | 33 | 28 | 35 |
早期退出(8-14天)1 | 8 | 2 | 0 | 2 |
基准退出(1-7天) | 9 | 11 | 17 | 8 |
退出百分数2 | 22 | 6 | 0 | 5 |
总计 | 46 | 46 | 45 | 45 |
Claims (84)
1.一种儿科配方,该配方基于100kcal含有约8至约16g的碳水化合物类,约3至约6g脂类,约1.8至约3.3g蛋白质和含约37至约370mg黄原胶的耐受性改进剂。
2.根据权利要求1的儿科配方,其中黄原胶为约74至约222mg。
3.根据权利要求1的儿科配方,其中黄原胶为约111至约148mg。
4.根据权利要求1的儿科配方,其中碳水化合物类为约9.4g至约12.3g。
5.根据权利要求1的儿科配方,其中脂类为约4.7g至约5.6g。
6.根据权利要求1的儿科配方,其中蛋白质为约2.4g至约3.3g。
7.根据权利要求1的儿科配方,还含有维生素和矿物质。
8.根据权利要求1的儿科配方,其中维生素和矿物质选自钙、磷、钠、氯、镁、锰、铁、铜、锌、硒、碘、维生素A、E、C、D、K和复合维生素B,和其混合物。
9.根据权利要求1的儿科配方,其中脂类选自椰子油、豆油、玉米油、橄榄油、红花油、高油酸红花油、MCT油(中链甘油三酸酯)、向日葵油、高油酸向日葵油、棕榈油、棕榈油精、卡诺拉油、花生四烯酸和二十二碳六烯酸的脂类源和其混合物。
10.根据权利要求1的儿科配方,其中包括完整蛋白质的蛋白质选自大豆基蛋白质、乳基蛋白质、酪蛋白、乳清蛋白、米蛋白、牛肉胶原、豌豆蛋白、马铃薯蛋白和其混合物。
11.根据权利要求1的儿科配方,其中包括水解蛋白质的蛋白质选自水解大豆蛋白、水解酪蛋白、水解乳清蛋白、水解大米蛋白、水解马铃薯蛋白、水解鱼蛋白、水解卵清蛋白、水解明胶蛋白,水解动物和植物蛋白的组合和其混合物。
12.根据权利要求1的儿科配方,其中包括游离氨基酸的蛋白质选自色氨酸、酪氨酸、胱氨酸、牛磺酸、L-蛋氨酸、L一精氨酸和肉毒碱,和其混合物。
13.根据权利要求1的儿科配方,其中碳水化合物类选自水解的、完整的、天然的和化学变性淀粉,所述淀粉源自糯性或非糯性的玉米、木薯、大米或马铃薯;和糖例如葡萄糖、果糖、乳糖、蔗糖、麦芽糖、高果玉米糖浆和其混合物。
14.根据权利要求1的儿科配方,其中还含有稳定剂,选自阿拉伯树胶、阔叶榆绿木胶、刺梧桐胶、黄芪胶、琼脂、丹麦琼脂、瓜尔豆胶、吉兰糖胶、槐树豆胶、果胶、低甲氧基果胶、明胶、微晶纤维素、CMC、甲基纤维素羟丙基甲基纤维素、羟丙基纤维素、葡萄聚糖、角叉菜胶和其混合物。
15.一种粉末形式的儿科配方,该配方基于100g粉末,含有约30至约90g的碳水化合物类,约15至约30g脂肪,约8至约17g蛋白质和约188至约1880mg黄原胶。
16.根据权利要求15的儿科配方,其中黄原胶为约375至约1125mg。
17.根据权利要求15的儿科配方,其中黄原胶为约565至约750mg。
18.根据权利要求15的儿科配方,其中碳水化合物类为约48g至约59g。
19.根据权利要求15的儿科配方,其中脂类为约22g至约28g。
20.根据权利要求15的儿科配方,其中蛋白质为约11g至约17g。
21.根据权利要求15的儿科配方,还含有维生素和矿物质。
22.根据权利要求15的儿科配方,其中维生素和矿物质选自钙、磷、钠、氯、镁、锰、铁、铜、锌、硒、碘、维生素A、E、C、D、K和复合维生素B,和其混合物。
23.根据权利要求15的儿科配方,其中脂类选自椰子油、豆油、玉米油、橄榄油、红花油、高油酸红花油、MCT油(中链甘油三酸酯)、向日葵油、高油酸向日葵油、棕榈油、棕榈油精、卡诺拉油、花生四烯酸和二十二碳六烯酸的脂类源和其混合物。
24.根据权利要求15的儿科配方,其中含有完整蛋白质的蛋白质选自大豆基蛋白质、乳基蛋白质、酪蛋白、乳清蛋白、米蛋白、牛肉胶原、豌豆蛋白、马铃薯蛋白和其混合物。
25.根据权利要求15的儿科配方,其中含有水解蛋白质的蛋白质选自水解大豆蛋白、水解酪蛋白、水解乳清蛋白、水解大米蛋白、水解马铃薯蛋白、水解鱼蛋白、水解卵清蛋白、水解明胶蛋白,水解动物和植物蛋白的组合和其混合物。
26.根据权利要求15的儿科配方,其中含有游离氨基酸的蛋白质选自色氨酸、酪氨酸、胱氨酸、牛磺酸、L-蛋氨酸、L-精氨酸和肉毒碱,和其混合物。
27.根据权利要求15的儿科配方,其中碳水化合物类选自水解的、完整的、天然的和化学变性淀粉,所述淀粉源自糯性或非糯性的玉米、木薯、大米或马铃薯;和糖例如葡萄糖、果糖、乳糖、蔗糖、麦芽糖、高果玉米糖浆和其混合物。
28.根据权利要求15的儿科配方,其中还含有稳定剂,选自阿拉伯树胶、阔叶榆绿木胶、刺梧桐胶、黄芪胶、琼脂、丹麦琼脂、瓜尔豆胶、吉兰糖胶、槐树豆胶、果胶、低甲氧基果胶、明胶、微晶纤维素、CMC、甲基纤维素羟丙基甲基纤维素、羟丙基纤维素、DATEM、葡萄聚糖、角叉菜胶和其混合物。
29.一种给病儿提供营养的方法,包括服用一种有效量的儿科配方,该配方基于100kcal含有约8至约16g的碳水化合物类,约3至约6g脂类,约1.8至约3.3g蛋白质和含约37至约370mg黄原胶的耐受性改进剂。
30.根据权利要求29的方法,其中黄原胶为约74至约222mg。
31.根据权利要求29的方法,其中黄原胶为约111至约148mg。
32.根据权利要求29的方法,其中碳水化合物类为约9.4g至约12.3g。
33.根据权利要求29的方法,其中脂类为约4.7g至约5.6g。
34.根据权利要求29的方法,其中蛋白质为约2.4g至约3.3g。
35.根据权利要求29的方法,还含有维生素和矿物质。
36.根据权利要求35的方法,其中维生素和矿物质选自钙、磷、钠、氯、镁、锰、铁、铜、锌、硒、碘、维生素A、E、C、D、K和复合维生素B,和其混合物。
37.根据权利要求29的方法,其中脂类选自椰子油、豆油、玉米油、橄榄油、红花油、高油酸红花油、MCT油(中链甘油三酸酯)、向日葵油、高油酸向日葵油、棕榈油、棕榈油精、卡诺拉油、花生四烯酸和二十二碳六烯酸的脂类源和其混合物。
38.根据权利要求29的方法,其中含有完整蛋白质的蛋白质选自大豆基蛋白质、乳基蛋白质、酪蛋白、乳清蛋白、米蛋白、牛肉胶原、豌豆蛋白、马铃薯蛋白和其混合物。
39.根据权利要求29的方法,其中含有水解蛋白质的蛋白质选自水解大豆蛋白、水解酪蛋白、水解乳清蛋白、水解大米蛋白、水解马铃薯蛋白、水解鱼蛋白、水解卵清蛋白、水解明胶蛋白,水解动物和植物蛋白的组合和其混合物。
40.根据权利要求29的方法,其中含有游离氨基酸的蛋白质选自色氨酸、酪氨酸、胱氨酸、牛磺酸、L-蛋氨酸、L-精氨酸和肉毒碱,和其混合物。
41.根据权利要求29的方法,其中碳水化合物类选自水解的、完整的、天然的和化学变性淀粉,所述淀粉源自糯性或非糯性的玉米、木薯、大米或马铃薯;和糖例如葡萄糖、果糖、乳糖、蔗糖、麦芽糖、高果玉米糖浆和其混合物。
42.根据权利要求29的方法,其中还含有稳定剂,选自阿拉伯树胶、阔叶榆绿木胶、刺梧桐胶、黄芪胶、琼脂、丹麦琼脂、瓜尔豆胶、吉兰糖胶、槐树豆胶、果胶、低甲氧基果胶、明胶、微晶纤维素、CMC、甲基纤维素羟丙基甲基纤维素、羟丙基纤维素、DATEM、葡萄聚糖、角叉菜胶和其混合物。
43.一种给病儿提供营养的方法,包括服用一种有效量的由粉末组合物重组的儿科配方,该配方基于100g粉末,含有约30至约90g的碳水化合物类,约15至约30g脂肪,约8至约17g蛋白质和约188至约1880mg黄原胶。
44.根据权利要求43的方法,其中黄原胶为约375至约1125mg。
45.根据权利要求43的方法,其中黄原胶为约565至约750mg。
46.根据权利要求43的方法,其中碳水化合物类为约48g至约59g。
47.根据权利要求43的方法,其中脂类为约22g至约28g。
48.根据权利要求43的方法,其中蛋白质为约11g至约17g。
49.根据权利要求43的方法,其中该配方还含有维生素和矿物质。
50.根据权利要求49的方法,其中维生素和矿物质选自钙、磷、钠、氯、镁、锰、铁、铜、锌、硒、碘、维生素A、E、C、D、K和复合维生素B,和其混合物。
51.根据权利要求43的方法,其中脂类选自椰子油、豆油、玉米油、橄榄油、红花油、高油酸红花油、MCT油(中链甘油三酸酯)、向日葵油、高油酸向日葵油、棕榈油、棕榈油精、卡诺拉油、花生四烯酸和二十二碳六烯酸的脂类源和其混合物。
52.根据权利要求43的方法,其中含有完整蛋白质的蛋白质选自大豆基蛋白质、乳基蛋白质、酪蛋白、乳清蛋白、米蛋白、牛肉胶原、豌豆蛋白、马铃薯蛋白和其混合物。
53.根据权利要求43的方法,其中含有水解蛋白质的蛋白质选自水解大豆蛋白、水解酪蛋白、水解乳清蛋白、水解大米蛋白、水解马铃薯蛋白、水解鱼蛋白、水解卵清蛋白、水解明胶蛋白,水解动物和植物蛋白的组合和其混合物。
54.根据权利要求43的方法,其中含有游离氨基酸的蛋白质选自色氨酸、酪氨酸、胱氨酸、牛磺酸、L-蛋氨酸、L-精氨酸和肉毒碱,和其混合物。
55.根据权利要求43的方法,其中碳水化合物类选自水解的、完整的、天然的和化学变性淀粉,所述淀粉源自糯性或非糯性的玉米、木薯、大米或马铃薯;和糖例如葡萄糖、果糖、乳糖、蔗糖、麦芽糖、高果玉米糖浆和其混合物。
56.根据权利要求43的方法,其中该配方还含有稳定剂,选自阿拉伯树胶、阔叶榆绿木胶、刺梧桐胶、黄芪胶、琼脂、丹麦琼脂、瓜尔豆胶、吉兰糖胶、槐树豆胶、果胶、低甲氧基果胶、明胶、微晶纤维素、CMC、甲基纤维素羟丙基甲基纤维素、羟丙基纤维素、DATEM、葡萄聚糖、角叉菜胶和其混合物。
57.一种改善病儿耐受性的方法,包括服用一种有效量的儿科配方,该配方基于100kcal含有约8至约16g的碳水化合物类,约3至约6g脂类,约1.8至约3.3g蛋白质和含约37至约370mg黄原胶的耐受性改进剂。
58.根据权利要求57的方法,其中黄原胶为约74至约222mg。
59.根据权利要求57的方法,其中黄原胶为约111至约148mg。
60.根据权利要求57的方法,其中碳水化合物类为约9.4g至约12.3g。
61.根据权利要求57的方法,其中脂类为约4.7g至约5.6g。
62.根据权利要求57的方法,其中蛋白质为约2.4g至约3.3g。
63.根据权利要求57的方法,还含有维生素和矿物质。
64.根据权利要求57的方法,其中维生素和矿物质选自钙、磷、钠、氯、镁、锰、铁、铜、锌、硒、碘、维生素A、E、C、D、K和复合维生素B,和其混合物。
65.根据权利要求57的方法,其中脂类选自椰子油、豆油、玉米油、橄榄油、红花油、高油酸红花油、MCT油(中链甘油三酸酯)、向日葵油、高油酸向日葵油、棕榈油、棕榈油精、卡诺拉油、花生四烯酸和二十二碳六烯酸的脂类源和其混合物。
66.根据权利要求57的方法,其中含有完整蛋白质的蛋白质选自大豆基蛋白质、乳基蛋白质、酪蛋白、乳清蛋白、米蛋白、牛肉胶原、豌豆蛋白、马铃薯蛋白和其混合物。
67.根据权利要求57的方法,其中含有水解蛋白质的蛋白质选自水解大豆蛋白、水解酪蛋白、水解乳清蛋白、水解大米蛋白、水解马铃薯蛋白、水解鱼蛋白、水解卵清蛋白、水解明胶蛋白,水解动物和植物蛋白的组合和其混合物。
68.根据权利要求57的方法,其中含有游离氨基酸的蛋白质选自色氨酸、酪氨酸、胱氨酸、牛磺酸、L-蛋氨酸、L-精氨酸和肉毒碱,和其混合物。
69.根据权利要求57的方法,其中碳水化合物类选自水解的、完整的、天然的和化学变性淀粉,所述淀粉源自糯性或非糯性的玉米、木薯、大米或马铃薯;和糖例如葡萄糖、果糖、乳糖、蔗糖、麦芽糖、高果玉米糖浆和其混合物。
70.根据权利要求57的方法,其中还含有稳定剂,选自阿拉伯树胶、阔叶榆绿木胶、刺梧桐胶、黄芪胶、琼脂、丹麦琼脂、瓜尔豆胶、吉兰糖胶、槐树豆胶、果胶、低甲氧基果胶、明胶、微晶纤维素、CMC、甲基纤维素羟丙基甲基纤维素、羟丙基纤维素、DATEM、葡萄聚糖、角叉菜胶和其混合物。
71.一种改善病儿耐受性的方法,包括服用一种有效量的由粉末组合物重组的儿科配方,该配方基于100g粉末,含有约30至约90g的碳水化合物类,约15至约30g脂肪,约8至约17g水解蛋白质和约188至约1880mg黄原胶。
72.根据权利要求71的方法,其中黄原胶为约375至约1125mg。
73.根据权利要求71的方法,其中黄原胶为约565至约750mg。
74.根据权利要求71的方法,其中碳水化合物类为约48g至约59g。
75.根据权利要求71的方法,其中脂类为约22g至约28g。
76.根据权利要求71的方法,其中蛋白质为约11g至约17g。
77.根据权利要求71的方法,其中该配方还含有维生素和矿物质。
78.根据权利要求7 7的方法,其中维生素和矿物质选自钙、磷、钠、氯、镁、锰、铁、铜、锌、硒、碘、维生素A、E、C、D、K和复合维生素B,和其混合物。
79.根据权利要求71的方法,其中脂类选自椰子油、豆油、玉米油、橄榄油、红花油、高油酸红花油、MCT油(中链甘油三酸酯)、向日葵油、高油酸向日葵油、棕榈油、棕榈油精、卡诺拉油、花生四烯酸和二十二碳六烯酸的脂类源和其混合物。
80.根据权利要求71的方法,其中含有完整蛋白质的蛋白质选自大豆基蛋白质、乳基蛋白质、酪蛋白、乳清蛋白、米蛋白、牛肉胶原、豌豆蛋白、马铃薯蛋白和其混合物。
81.根据权利要求71的方法,其中含有水解蛋白质的蛋白质选自水解大豆蛋白、水解酪蛋白、水解乳清蛋白、水解大米蛋白、水解马铃薯蛋白、水解鱼蛋白、水解卵清蛋白、水解明胶蛋白,水解动物和植物蛋白的组合和其混合物。
82.根据权利要求71的方法,其中含有游离氨基酸的蛋白质选自色氨酸、酪氨酸、胱氨酸、牛磺酸、L-蛋氨酸、L-精氨酸和肉毒碱,和其混合物。
83.根据权利要求71的方法,其中碳水化合物类选自水解的、完整的、天然的和化学变性淀粉,所述淀粉源自糯性或非糯性的玉米、木薯、大米或马铃薯;和糖例如葡萄糖、果糖、乳糖、蔗糖、麦芽糖、高果玉米糖浆和其混合物。
84.根据权利要求71的方法,其中该配方还含有稳定剂,选自阿拉伯树胶、阔叶榆绿木胶、刺梧桐胶、黄芪胶、琼脂、丹麦琼脂、瓜尔豆胶、吉兰糖胶、槐树豆胶、果胶、低甲氧基果胶、明胶、微晶纤维素、CMC、甲基纤维素羟丙基甲基纤维素、羟丙基纤维素、DATEM、葡萄聚糖、角叉菜胶和其混合物。
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US5681600A (en) | 1995-12-18 | 1997-10-28 | Abbott Laboratories | Stabilization of liquid nutritional products and method of making |
WO1997037547A1 (en) | 1996-04-09 | 1997-10-16 | E.I. Du Pont De Nemours And Company | Novel isoflavone-enriched soy protein product and method for its manufacture |
US6365218B1 (en) * | 2000-02-04 | 2002-04-02 | Abbott Laboratories | Pediatric formula and methods for providing nutrition and improving tolerance |
-
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- 2000-02-04 US US09/498,350 patent/US6365218B1/en not_active Expired - Lifetime
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2001
- 2001-01-16 AU AU29490/01A patent/AU780438B2/en not_active Ceased
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- 2001-01-16 CN CN01804563A patent/CN1400870A/zh active Pending
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- 2001-01-16 DK DK01948924T patent/DK1251750T3/da active
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- 2001-02-02 TW TW090102265A patent/TWI241167B/zh not_active IP Right Cessation
- 2001-10-24 US US10/004,360 patent/US6589576B2/en not_active Expired - Lifetime
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CN102186360A (zh) * | 2008-10-20 | 2011-09-14 | 雀巢产品技术援助有限公司 | 具有抗反流性质的营养组合物 |
CN102186360B (zh) * | 2008-10-20 | 2016-08-17 | 雀巢产品技术援助有限公司 | 具有抗反流性质的营养组合物 |
CN102413716A (zh) * | 2009-04-27 | 2012-04-11 | 荷兰纽迪希亚公司 | 控制蛋白的消化性凝固的方法 |
CN102753043A (zh) * | 2009-12-22 | 2012-10-24 | 雀巢产品技术援助有限公司 | 优化膳食酸-碱电位的营养组合物和方法 |
CN103354720A (zh) * | 2010-12-17 | 2013-10-16 | 联合医药公司 | 抗反胃和/或抗胃食管反流组合物、制备和用途 |
CN103354720B (zh) * | 2010-12-17 | 2017-01-18 | 联合医药公司 | 抗反胃和/或抗胃食管反流组合物、制备和用途 |
CN104284602A (zh) * | 2012-03-09 | 2015-01-14 | N.V.纽迪希亚公司 | 包含游离氨基酸的液体营养组合物 |
CN105246356A (zh) * | 2013-05-07 | 2016-01-13 | 联合医药公司 | 维持肠运动的抗反胃组合物 |
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