CN104302297A - 用于治疗皮肤疾病的寡糖组合物 - Google Patents
用于治疗皮肤疾病的寡糖组合物 Download PDFInfo
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- CN104302297A CN104302297A CN201180056411.7A CN201180056411A CN104302297A CN 104302297 A CN104302297 A CN 104302297A CN 201180056411 A CN201180056411 A CN 201180056411A CN 104302297 A CN104302297 A CN 104302297A
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- lactose
- skin
- oligosaccharide
- atopic dermatitis
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Abstract
本发明公开了一种组合物,其包含至少一种N-乙酰基-乳糖胺、至少一种唾液酸化寡糖和至少一种岩藻糖基化寡糖,所述组合物用于预防和/或治疗皮肤病症和皮肤疾病。优选地所述组合物是一段婴儿配方。所述的皮肤疾病特别是特应性皮炎。
Description
本发明涉及用于预防/或治疗皮肤病症(例如增强皮肤健康)和皮肤疾病、特别是特应性皮炎的组合物。
发明背景
特应性皮炎是一种慢性瘙痒性皮肤病,其常见于儿童,但可以发生于任何年龄。它还被称作湿疹或特应性湿疹。在幼儿(young children)年龄组中在食物变态反应(food allergy)与特应性皮炎之间有强关联性,而食物变态反应疑似常见于具有特应性皮炎的儿童中。
特应性皮炎通常发生在具有特应性趋向的人中。这意味着他们可能发生三种紧密相关的病症中的任意一种或全部:特应性皮炎、哮喘和花粉病(变应性鼻炎)。
特应性皮炎的现象如下发生。响应于某些触发因素敏感性皮肤以皮疹的形式突发斑。这些触发因素因人而异。就婴儿(infant)和幼儿而言,需要当心的常见触发因素列表包括牛奶和其它可能的婴儿配方成分,例如小麦或大豆。特应性皮炎可变成恶性循环。某些物质刺激儿童皮肤,从而使其发红和发炎。它引起瘙痒,儿童搔抓它,且皮肤变得更为发炎。皮肤外保护层消失,受累区域变得对刺激物甚至更敏感且易于脱水。婴儿持续暴露于最初触发这些事件的情况。皮疹进一步发生,该循环自身持续存在。
尚不了解特应性皮炎的单一原因。它可能反映一种以上病症。有关潜在的机制存在许多理论。目前的研究正在探讨聚丝蛋白基因突变、皮肤细胞(角质细胞)缺陷、免疫系统、皮肤表面微生物(细菌、病毒和酵母)和许多其它因素的作用。
所有皮肤病症和皮肤疾病均能影响一般群体或处于变态反应风险中的人群或变应性的(因此患病的)人群。
所述皮肤病症和皮肤疾病且特别是特应性皮炎对婴儿、婴孩(baby)或儿童而言特别重要,因为他们具有正经历密集生长和增殖期的敏感性皮肤,这使得其甚至更易于发生皮肤疾病。其家族中无变态反应史并且其变成变应性的婴儿群体正在增加。
低变应原性食品是一类不可能导致变态反应的食品。已经开发了特别针对婴儿配方的低变应原性食品,因为婴儿和儿童变成越来越可能在其生命的前几个月/前几年中发生变态反应。
低变应原性婴儿配方用于补救(help)、预防和治疗变应性疾病以及特别是婴儿和有时是幼儿中的食物变态反应。它们一般不使用常见的变应原如小麦、大豆和乳制品制备。它们通常也来源于牛奶,但是由于其蛋白质被分解的方式,它们被大部分婴儿良好耐受。
低变应原性婴儿配方一般分成三种主要类型:部分水解的、彻底水解的和基于游离氨基酸的。水解的婴儿配方具有分解成较短的易于消化的蛋白质的较大蛋白质链,而游离氨基酸配方根本不包括蛋白质链,而是含有所有碱性氨基酸。部分水解的婴儿配方不同于彻底水解的婴儿配方,不同之处在于它们的蛋白质链可能更长。低变应原性婴儿配方具有缺点,即它们的成本远高于常规牛奶配方的成本。
然而,对用于预防和/或治疗婴儿和甚至是幼儿可能发生的皮肤病症和皮肤疾病、尤其是特应性皮炎的低变应原性婴儿配方仍然存在需求。
人乳寡糖(HMO)总的是人乳中排在乳糖和脂肪之后的第三大固体组份。HMO通常由还原端的乳糖与非还原端的通常含有岩藻糖或唾液酸的碳水化合物芯组成。大约存在100种已经被分离和表征的乳寡糖,然而这些寡糖仅占尚未表征的总数的一个极少的部分。
过去,针对不同目的,使用HMO成分例如岩藻糖基化寡糖(fucosylatedoligosaccharide)、乳糖-N-四糖(lacto-N-tetraose)、乳糖-N-新四糖(lacto-N-neotetraose)或唾液酸化寡糖(sialylated oligosaccharide)开发了婴儿配方。
Abbott Laboratories的EP0975235B1描述了包含一种或多种人乳寡糖的合成营养组合物,其中该组合物中的HMO选自8种HMO(3-岩藻糖基乳糖、乳糖-N-岩藻五糖(lacto-N-fucopentaose)III、乳糖-N-岩藻五糖II、二岩藻糖基乳糖(difucosyllactose)、2’-岩藻糖基乳糖、乳糖-N-岩藻五糖I、乳糖-N-新四糖和乳糖-N-岩藻五糖V),其中所述组合物旨在用于如下情况:正常的、健康的婴儿、儿童、成人或具有专门需求的个体,例如伴随某些病理学情况的那些个体。该欧洲专利说明:一般而言,寡糖保护婴儿避免呼吸道、胃肠道和泌尿生殖道的病毒和细菌感染。关于特应性皮炎的问题以及更广泛地皮肤疾病的预防和/或治疗,没有提及。
从以上内容可以看出,对用于预防继发性特应性皮炎或促进皮肤健康(特别是在婴儿和幼儿中预防继发性特应性皮炎或促进皮肤健康)并且可以方便地和安全地施用的有效营养组合物存在需求。
对通过与脆弱的个体如婴儿或婴孩相容的基于非药物的干预改善皮肤病症或皮肤疾病例如特应性皮炎存在需求。
对长期降低所述皮肤病症和皮肤疾病的频率、发生率、严重性和/或持续时间的作用存在需求。此外,对“随后的生命期”、尤其是干预后一些年中变得可测的作用存在需求。
对处于或未处于变态反应风险中的婴儿、婴孩和儿童的诱导变应性表现、尤其是皮肤的变应性表现减轻的食物干预存在需求。
对诱导维持或改善皮肤健康的所述干预存在需求。
发明概述
本发明的发明人已经令人惊讶地发现,施用特定人寡糖的混合物在预防和/或治疗皮肤病症和皮肤疾病、特别是在预防和/或治疗特应性皮炎方面和/或在促进皮肤健康方面特别有效。
因此,本发明提供了一种组合物,其包含至少一种N-乙酰基乳糖胺(N-acetyl lactosamine)、至少一种唾液酸化寡糖和至少一种岩藻糖基化寡糖,所述组合物用于预防和/或治疗皮肤病症和皮肤疾病,优选特应性皮炎。
所述组合物优选是合成营养组合物。所述组合物作为合成营养组合物包括三种不同类型的用途。在第一种情况中,个体且特别是婴儿是健康的,因为在它们的家族中没有变态反应史而不具有任何变态反应的风险。在第二种情况中,个体且特别是婴儿是健康的,但是由于在它们的家族中有变态反应史而具有变态反应的风险。在第三种情况中,个体且特别是婴儿是变应性的,并且因此是患病的。第一种情况是本发明的优选的目标。
发明详述
本文所用的下列术语具有如下含义。
术语“婴儿”意指年龄12个月以下的儿童。
术语“幼儿”意指年龄在1岁至3岁之间的儿童。
术语“婴儿配方”意指用于在生命的前4至6个月期间的婴儿的特别营养用途的并且其本身满足该类人的营养需求的食品(1991年5月14日的有关婴儿配方和第二阶段配方的欧洲委员会指令91/321/EEC第1.2条(Article1.2of the European Commission Directive91/321/EEC of May14,1991on infant formulae and follow-on formulae))。
术语“第二阶段配方”意指用于年龄4个月以上的婴儿的特别营养用途的并且构成该类人的日趋多样的饮食中的主要液体要素的食品。
术语“一段婴儿配方(starter infant formula)”意指用于在生命的前四个月期间的婴儿的特别营养用途的食品。
术语“婴孩食品”意指用于在生命的前几年期间的婴儿的特别营养用途的食品。
术语“婴儿谷物组合物”意指用于在生命的前几年期间的婴儿的特别营养用途的食品。
术语“成长奶(growing-up milk)”意指适合幼儿的特别营养需求的基于奶的饮料。
术语“断乳期”意指在此期间用婴儿饮食中的其它食物替代母乳的一段时间。
术语“皮肤疾病”意指特应性皮炎和其它相关皮肤问题。湿疹是特应性皮炎。
术语“预防和/或治疗皮肤疾病”或“皮肤疾病的预防和/或治疗”意指预防皮肤疾病、即特应性皮炎和其它相关皮肤问题、特别是特应性皮炎和降低皮肤疾病、即特应性皮炎和其它相关皮肤问题、特别是特应性皮炎的频率和/或发生率和/或严重性和/或持续时间。发生率涉及任意皮肤疾病的数量。频率涉及相同皮肤疾病的数量。这种预防包括降低随后的生命期的所述皮肤疾病的频率和/或严重性。术语“随后的生命期”包括干预终止后的作用。作用“随后的生命期”可以优选是所述干预终止后2-4周、2-12个月或数年(例如2年、5年、10年)。
术语“皮肤病症”意指刺激、妨碍皮肤或使皮肤发炎的病症。皮肤病症可导致皮肤疾病症状,例如发红、肿胀、烧灼和瘙痒。
术语“预防和/或治疗皮肤病症”或“皮肤病症的预防和/或治疗”意指促进皮肤健康和/或预防皮肤脱水和/或增强皮肤水化和/或减轻皮肤的皮疹、粗糙度和/或干燥。这种预防还包括建立可见的或隐藏的表型,其伴随在随后的生命期中所述皮肤病症的频率、发生率、严重性和/或持续时间的降低。
术语“增强对变应原的口服耐受性”意指当口服摄入时对变应原的敏感性降低。
术语“营养组合物”意指给受处理者(subject)提供营养的组合物。该营养组合物通常通过口服或静脉内摄入,它通常包含脂质或脂肪来源和蛋白质来源。
术语“合成混合物”意指通过化学和/或生物学方法得到的混合物,其在化学上可以与天然存在于哺乳动物乳中的混合物相同。只要其组分中至少一种是通过化学和/或生物学(例如酶)方法获得的,就将组合物称为是合成的。
术语“低变应原性营养组合物”意指不可能导致变态反应的营养组合物。
术语“唾液酸化寡糖”意指具有唾液酸残基的寡糖。
术语“岩藻糖基化寡糖”意指具有岩藻糖残基的寡糖。
术语“益生元”意指不可消化的碳水化合物,其通过选择性地刺激人结肠中健康细菌例如双歧杆菌属(bifidobacteria)的生长和/或活性而有益地影响宿主(Gibson GR,Roberfroid MB.人结肠微生物丛的饮食调节:引入益生元的概念(Dietary modulation of the human colonic microbiota:introducingthe concept of prebiotics).J Nutr.1995;125:1401-12)。
术语“益生菌”意指对宿主的健康或良好状态具有有益作用的微生物细胞制品或微生物细胞组分(Salminen S,Ouwehand A.Benno Y.等人“益生菌:应当如何定义它们(Probiotics:how should they be defined)”TrendsFood Sci.Technol.1999:10107-10)。
“变态反应”是已经被医生检测到的并且可以偶尔地或以更持久的方式被治疗的变态反应。
除非另有说明,否则所有百分比均是重量百分比。
本发明的组合物优选是低变应原性组合物。
所述组合物含有至少一种N-乙酰基-乳糖胺。也就是说,本发明的组合物含有N-乙酰基-乳糖胺和/或含N-乙酰基-乳糖胺的寡糖。适合的含N-乙酰基-乳糖胺的寡糖包括乳糖-N-四糖(LNT)和乳糖-N-新四糖(LNnT)。
因此,根据本发明,N-乙酰基-乳糖胺优选选自乳糖-N-四糖(LNT)和乳糖-N-新四糖(LNnT)。
LNT和LNnT可以通过使用例如美国专利No.5,288,637和WO96/10086中所述的糖基转移酶将糖单元从供体部分酶促转移到受体部分来化学合成。作为替代选择,LNT和LNnT可以通过游离的或与寡糖(例如乳果糖)结合的己酮糖(例如果糖)化学转化为N-乙酰基己糖胺或含N-乙酰基己糖胺的寡糖来制备,如Wrodnigg,T.M.;Stutz,A.E.(1999)Angew.Chem.Int.Ed.38:827-828中所述。然后可以将以该方法产生的N-乙酰基-乳糖胺转移至作为受体部分的乳糖。
优选地,以干重为基础,本发明的组合物每100g组合物含有0.1-3g N-乙酰基-乳糖胺。
根据本发明,唾液酸化寡糖选自3’-唾液酸乳糖(sialyllactose)和6’-唾液酸乳糖。优选地,3’-唾液酸乳糖和6’-唾液酸乳糖都存在于所述组合物中。在该实施方案中,3’-唾液酸乳糖与6’-唾液酸乳糖之比优选在5:1-1:2的范围内。
可以通过色谱法或过滤技术从天然来源例如动物乳中分离3’-和6’-形式的唾液酸乳糖。作为替代选择,可以通过生物技术方法使用特异性唾液酸转移酶或唾液酸酶、神经氨酸酶、通过基于酶的发酵技术(重组或天然酶)、通过化学合成或通过微生物发酵技术生产它们。在后一种情况中,微生物可以表达它们的天然酶和底物或者可以被改造以产生相应的底物和酶。可以使用单一微生物培养物或混合培养物。可以通过受体底物始于任意聚合度(DP)、从DP=1向前启动唾液酸寡糖形成。作为替代选择,可以通过化学合成由乳糖和游离N’-乙酰基神经氨酸(唾液酸)生产唾液酸乳糖。唾液酸乳糖还可以从例如日本的Kyowa Hakko Kogyo商购获得。
优选地,以干重为基础,本发明的组合物每100g组合物含有0.05-2g、更优选0.1-2g一种或多种唾液酸化寡糖。
岩藻糖基化寡糖可以选自2’-岩藻糖基乳糖、3-岩藻糖基乳糖、二岩藻糖基乳糖、乳糖-N-岩藻五糖(即乳糖-N-岩藻五糖I、乳糖-N-岩藻五糖II、乳糖-N-岩藻五糖III和乳糖-N-岩藻五糖V)、乳糖-N-二岩藻己糖I(lacto-N-difucohexaose I)、岩藻糖基乳糖-N-己糖(fucosyllacto-N-hexaose)、二岩藻糖基乳糖-N-己糖I(Difucosyllacto-N-hexaose I)和二岩藻糖基乳糖-N-新己糖II(Difucosyllacto-N-neohexaose II)。特别优选的岩藻糖基化寡糖是2’-岩藻糖基乳糖(2-FL)。
可以通过色谱法或过滤技术从天然来源例如动物乳中分离岩藻糖基化寡糖。作为替代选择,它可以通过生物技术方法使用特异性岩藻糖基转移酶和/或岩藻糖苷酶通过使用基于酶的发酵技术(重组或天然酶)或微生物发酵技术生产。在后一种情况中,微生物可以表达它们的天然酶和底物或者可以被改造以产生相应的底物和酶。可以使用单一微生物培养物或混合培养物。可以通过受体底物始于任意聚合度(DP)、从DP=1向前启动岩藻糖基化寡糖形成。作为替代选择,可以通过化学合成由乳糖和游离岩藻糖生产岩藻糖基化乳糖。岩藻糖基化乳糖还可以从例如日本的Kyowa HakkoKogyo获得。
优选地,以干重为基础,本发明的组合物每100g组合物含有0.1-3g一种或多种岩藻糖基化寡糖。
在一个优选的实施方案中,本发明的组合物每100g组合物包含总量为0.05-3g一种或多种N-乙酰化乳糖胺、一种或多种唾液酸化寡糖和一种或多种岩藻糖基化寡糖。
本发明的组合物还可以包含至少一种益生菌菌株,所述益生菌菌株优选是双歧杆菌属和/或乳杆菌属(Lactobacilli)。
适合的益生菌菌株包括从芬兰的Valio Oy可获得的商标为LGG的鼠李糖乳杆菌(Lactobacillus rhamnosus)ATCC53103、鼠李糖乳杆菌CGMCC1.3724、副干酪乳杆菌(Lactobacillus paracasei)CNCM I-2116、BioGaia A.B以商标Reuteri销售的罗伊氏乳杆菌(Lactobacillus reuteri)、约氏乳杆菌(Lactobacillus johnsonii)CNCM I-1225、新西兰的BLIS TechnologiesLimited以名称KI2销售的唾液链球菌(Streptococcus salivarius)DSM13084、尤其是丹麦的Christian Hansen公司以商标Bb12销售的乳双歧杆菌(Bifidobacterium lactis)CNCM I-3446、日本的Morinaga Milk Industry Co.Ltd.以商标BB536销售的长双歧杆菌(Bifidobacterium longum)ATCCBAA-999、Danisco以商标Bb-03销售的短双歧杆菌(Bifidobacterium breve)、Morinaga以商标M-16V销售的短双歧杆菌、Procter&Gamble Co.以商标Bifantis销售的婴儿双歧杆菌(Bifidobacterium infantis)和Institut Rosell(Lallemand)以商标R0070销售的短双歧杆菌。
优选地,以干重为基础,本发明的组合物每克组合物含有10e3-10e12cfu益生菌菌株、更优选10e7-10e12cfu益生菌菌株。
本发明的组合物还可以包含至少一种益生元,通常其量为组合物的0.3-10重量%。
益生元通常是不可消化的,这意味着它们在胃或小肠中不被分解和吸收,因此当它们进入结肠时保持完整,在结肠中它们被有益细菌选择性地发酵。益生元的实例包括某些寡糖,例如低聚果糖(FOS)和低聚半乳糖(GOS)。可以使用益生元的组合,例如90%GOS和10%短链低聚果糖、例如BENEO-Orafti以商标“oligofructose”销售的产品(参见http://www.beneo-orafti.com/Our-Products/Oligofructose)(之前是),或90%GOS和10%菊糖、例如BENEO-Orafti以商标“inulin”销售的产品(参见http://www.beneo-orafti.com/Our-Products/Inulin)(之前是)。特别优选的益生元组合是70%短链低聚果糖和30%菊糖,其为BENEO-Orafti以商标“Prebio1”销售的产品。
本发明的组合物还可以包含其它营养化合物,其与所要求保护的寡糖具有协同作用以对皮肤、例如皮肤变态反应或特应性皮炎递送所要求保护的益处。这类另外的化合物可以是例如低变应原性蛋白质(即水解的或部分水解的蛋白质)、低乳糖成分或低乳糖糖。认为成分的协同作用可以通过如下事实建立:这些成分全部一起有助于维持低生理水平的效应器,其保持在皮肤效应(例如特应性皮炎)开始显现的阈值以下。
本发明的组合物优选是合成营养组合物。在这种情况中,它可以是一段婴儿配方、婴儿配方、婴孩食品、婴儿谷物组合物、第二阶段配方(follow-on formula)或成长奶,所述组合物优选是一段婴儿配方。
根据一个优选的实施方案,本发明的组合物用于健康婴儿和健康幼儿。
本发明的组合物可以在断乳期之前和/或期间使用。
因此,优选地,本发明的组合物用于降低特应性皮炎的频率和/或发生率和/或严重性和/或持续时间和/或用于促进皮肤健康。
在一种实施方式中,本发明的组合物用于促进皮肤健康和/或用于预防皮肤脱水和/或用于增强皮肤水化和/或用于减轻皮肤的皮疹、粗糙度和干燥和/或用于增强对变应原的口服耐受性。
本发明还包括包含至少一种N-乙酰基乳糖胺、至少一种唾液酸化寡糖和至少一种岩藻糖基化寡糖的组合物作为合成营养剂用于预防和/或治疗皮肤病症和皮肤疾病、优选特应性皮炎的用途。
本发明还包括包含至少一种N-乙酰基乳糖胺、至少一种唾液酸化寡糖和至少一种岩藻糖基化寡糖的组合物作为合成营养剂用于增强对变应原的口服耐受性的用途。
这些用途包括其中组合物是补充剂(优选以单位剂量形式被提供)的情况。
上述所有用途特别用于婴儿和幼儿。本发明的组合物和用途特别适合于处于变态反应风险中的、具有变态反应家族史的或已经经历了一些变态反应事件(尤其是呼吸系统变态反应或皮肤变态反应)的婴儿和儿童。在一个实施方案中,本发明的组合物和用途应用于处于变态反应风险中的或已经经历了变态反应事件(尤其是呼吸系统变态反应或皮肤变态反应)的青少年或成人。
不希望受理论束缚,本发明的发明人认为上述寡糖的组合在预防和/或治疗皮肤病症和皮肤疾病、特别是特应性皮炎中的效力可能是被乳酸细菌通过它们用特定寡糖掺合物的刺激所触发的粘膜免疫调节剂效应的协同作用组合的结果。本发明的发明人认为建立具有最低炎症刺激的大部分粘膜相关微生物丛是通过使用炎症调节剂例如半乳凝素(galectin)(例如半乳凝素-1和半乳凝素-3)的同时调节选择性地促进有益共生乳酸细菌来实现的。此外,所述组合物可以调节内源性微生物丛的代谢,从而导致短链脂肪酸的产生,其会促成激活肠粘膜下的免疫细胞。在触发粘膜免疫系统后,活化的免疫细胞、免疫活性化合物和/或免疫介体将循环至包括皮肤在内的远端位置,在远端位置它们将发挥免疫调节活性。这些机制加在一起促成平衡潜在的皮肤炎性病症,从而导致相关的临床表现例如皮炎和湿疹的改善。此外,本发明的发明人认为这类和谐配合的免疫性将表现为皮肤对外源性刺激物的更低的敏感性和更好的皮肤屏障功能,从而导致与反应性皮肤相关的皮肤的皮疹、粗糙度和干燥程度降低。
寡糖可以被在同一组合物中施用或者可以被相继施用。
如果针对的是生命的0-12个月的年龄组,则所述组合物优选是以液体形式被消耗的营养组合物。它可以是完全营养配方例如婴儿配方、第二阶段配方或成长奶。或者,对于幼儿组,所述组合物可以是果汁饮品或其它的冷冻的或贮存稳定的饮料或汤,例如,或婴孩食品,或婴儿谷物组合物。
本发明的组合物还含有蛋白质来源,优选其量为2.0g以下/100kcal,甚至更优选其量为1.8g以下/100kcal。相信蛋白质的类型对于本发明不是至关重要的,条件是满足对必需氨基酸含量的最小需求并且确保良好生长。因此,可以使用以乳清、酪蛋白及其混合物为基础的蛋白质来源以及以大豆为基础的蛋白质来源。就涉及乳清蛋白而言,蛋白质来源可以以酸乳清或甜乳清或其混合物为基础,并且可以包括任意所需比例的α-乳清蛋白和β-乳球蛋白。
本发明的组合物一般含有碳水化合物来源。在本发明的营养组合物是婴儿配方的情况中,这是特别优选的。在这种情况中,可以使用婴儿配方中常规存在的任何碳水化合物来源,例如乳糖、蔗糖、麦芽糖糊精、淀粉以及它们的混合物,但是优选的碳水化合物来源是乳糖。
本发明的组合物一般含有脂质来源。如果本发明的营养组合物是婴儿配方,则这是特别相关的。在这种情况中,脂肪来源可以是适用于婴儿配方的任意脂质或脂肪。优选的脂肪来源包括油酸棕榈油(palm oleic)、高油酸葵花油(high oleic sunflower oil)和高油酸红花油(high oleic saffloweroil)。还可以添加必需脂肪酸亚油酸和α-亚麻酸,就如同可以添加少量含大量预制的花生四烯酸和二十二碳六烯酸的油,例如鱼油或微生物油。脂肪来源优选具有约5:1-约15:1、例如约8:1-约10:1的n-6与n-3脂肪酸比。
本发明的组合物还优选含有被认为是每天的饮食中必需的且为营养显著量的所有维生素和矿物质。对于某些维生素和矿物质已经确定了最小需求量。本发明的组合物中任选存在的矿物质、维生素和其它营养素的实例包括维生素A、维生素B1、维生素B2、维生素B6、维生素B12、维生素E、维生素K、维生素C、维生素D、叶酸、肌醇、烟酸、生物素、泛酸、胆碱、钙、磷(phosphorous)、碘、铁、镁、铜、锌、锰、氯、钾、钠、硒、铬、钼、牛磺酸和L-肉碱。矿物质通常以盐形式被添加。特定的矿物质和其它维生素的存在和量将根据预期使用的群体而异。
如果需要,本发明的组合物可以含有乳化剂和稳定剂,例如大豆、卵磷脂、柠檬酸单-和二-甘油酯等。
本发明的组合物还可以含有其它可以具有有益作用的物质例如乳铁蛋白、核苷酸、核苷等。
现在本发明的组合物将通过实例被描述。
配方可以以任何适合的方法制备。例如,其可以通过将蛋白质、碳水化合物来源和脂肪来源以适宜的比例一起混合来制备。如果使用乳化剂,则此时可以包括乳化剂。维生素和矿物质也可以在此时加入,但是通常较迟加入,以避免热降解。可以将任何亲脂性的维生素、乳化剂等溶解入脂肪来源中,然后混合。然后可以混合入水(优选已经进行了反渗透的水),以形成液体混合物。水的温度方便地在约50℃-约80℃的范围内,以帮助成分分散。可以使用商购可获得的液化剂,以形成液体混合物。如果终产物具有液体形式,则在该阶段添加一种或多种N-乙酰基-乳糖胺、一种或多种唾液酸化寡糖和一种或多种岩藻糖基化寡糖。如果终产物是粉末,则如果需要,同样可以在该阶段添加寡糖。然后将液体混合物匀化,例如分两个阶段匀化。
然后可以将液体混合物热处理以减少细菌载量,例如通过将液体混合物快速加热至约80℃-约150℃范围内的温度达约5秒-约5分钟的一段时间。这可以通过蒸汽注入(steam injection)、高压灭菌器或热交换器(例如板式热交换器)来进行。
然后,可以将液体混合物冷却至约60℃至约85℃,例如通过快速冷却来实现。然后可以将液体混合物再次匀化,例如分两个阶段匀化,第一个阶段在约10MPa-约30MPa,第二个阶段在约2MPa-约10MPa。然后可以将匀化的混合物进一步冷却,以加入任何热敏感的组分,例如维生素和矿物质。此时方便地调节匀化的混合物的pH和固体含量。
将匀化的混合物转移至适合的干燥装置(例如喷雾干燥器或冷冻干燥器)中并且转化为粉末。所述粉末应当具有小于约5重量%的水分含量。在该阶段可以通过干混合加入一种或多种N-乙酰基-乳糖胺、一种或多种唾液酸化寡糖和一种或多种岩藻糖基化寡糖,以及一种或多种益生菌菌株(如果使用的话),或者通过将它们以晶体浆液形式与一种或多种益生菌菌株(如果使用的话)一起掺合来加入,并且喷雾干燥(或冷冻干燥)。
如果优选液体组合物,则可以将匀化的混合物灭菌,然后无菌灌装入适合的容器中,或者可以先灌装入容器中,然后甑馏。
在另一个实施方案中,本发明的组合物可以是补充剂,其包含足以在个体中实现所需作用的量的一种或多种N-乙酰基-乳糖胺、一种或多种唾液酸化寡糖和一种或多种岩藻糖基化寡糖。该施用形式更适合年龄较大的儿童和成人。优选地,所述的一种或多种N-乙酰基-乳糖胺的日剂量为0.1-3g,所述的一种或多种唾液酸化寡糖的日剂量为0.1-2g,所述的一种或多种岩藻糖基化寡糖的日剂量为0.1-3g。
包含在补充剂中的寡糖的量将根据补充剂被施用的方式而进行选择。例如,如果补充剂每天施用两次,则每种补充剂可以含有0.05-1.5g N-乙酰基-乳糖胺、0.05-1g唾液酸化寡糖和0.05-1.5g岩藻糖基化寡糖。
补充剂可以是例如片剂、胶囊剂、软锭剂(pastille)或液体的形式。补充剂可以进一步含有保护性的亲水胶体(例如树胶、蛋白质、改性淀粉)、粘合剂、成膜剂、包囊剂/材料、壁/壳材料、基质化合物、包衣、乳化剂、表面活性剂、增溶剂(油、脂肪、蜡、卵磷酯等)、吸附剂、载体、填充剂、共用化合物(co-compound)、分散剂、润湿剂、加工助剂(溶剂)、助流剂、掩味剂、增重剂(weighting agent)、成胶冻剂(jellifying agent)和凝胶形成剂。补充剂还可以含有常规的药物添加剂和佐剂、赋形剂和稀释剂,包括但不限于水、任何来源的明胶、植物胶、木素-磺酸盐(lignin-sulfonate)、滑石粉、糖、淀粉、阿拉伯胶、植物油、聚亚烷基二醇、矫味剂、防腐剂、稳定剂、乳化剂、缓冲剂、润滑剂、着色剂、润湿剂、填充剂等。
此外,根据政府机构例如USRDA的推荐,补充剂还可以含有适合于口服或胃肠外施用的有机或无机载体物质以及维生素、矿物质痕量元素和其它微量营养素。
本发明的婴儿配方的组合物的实例如下所示。该组合物仅作为举例说明给出。另一个实例基于商购NAN和/或催乳素婴儿配方(来自Nestlé,瑞士),其中添加了如下所示的量的本发明的特定寡糖。
实验数据:
发现概述
如下概述的发现显示特定寡糖掺合物促进乳酸细菌例如长双歧杆菌亚种婴儿双歧杆菌的代谢活性和生长。不希望受理论束缚,这种作用可能部分解释了如下观察结果:在其剖腹产孩子2岁以内发生了特应性变态反应且尤其是特应性湿疹的母亲的早期母乳中发现了较低量的这类特定寡糖掺合物。这表明,根据本发明,提供具有安全水平的特定寡糖掺合物的营养组合物可以帮助重建婴儿肠道中的细菌的天然平衡和/或因此在预防和/或治疗皮肤病症和皮肤疾病、优选特应性皮炎方面积极地影响健康状态。
研究模型1:长双歧杆菌亚种婴儿双歧杆菌的刺激
方法:
使长双歧杆菌亚种婴儿双歧杆菌(ATCC15697)以厌氧方式在补充了1%(w/v)葡萄糖或1%(w/v)2’岩藻糖基乳糖(2FL)或1%(w/v)乳糖-N-新四糖(LNnT)或1%(w/v)6’唾液酸乳糖(6SL)或1%(w/v)等量的2FL、LNnT和6SL的组合的API生长培养基中生长。将每一个过夜培养物在含有0.1%葡萄糖作为碳源的DMEM(达尔伯克氏改良伊格尔氏培养基(Dulbeccosmodified Eagle Medium))中稀释至具有0.1的起始OD600。在不具有任何另外的碳水化合物补充剂的情况下或者在具有另外的1%(w/v)葡萄糖或1%(w/v)2’岩藻糖基乳糖(2FL)或1%(w/v)乳糖-N-新四糖(LNnT)或1%(w/v)6’唾液酸乳糖(6SL)或1%(w/v)等量的2FL、LNnT和6SL的组合的情况下使用该培养基。因此于37°C在厌氧条件下进行DMEM培养基的条件调节。
在经过另外一个过夜温育后,通过在600nm测定OD监测细菌的生长。然后将条件培养基离心,通过0.22微米滤膜过滤上清液以除去细菌。通过使用Hi-Plex H柱和UV检测器的HPLC对条件培养基中的乙酸根(acetate)进行定量。
结果:
我们令人惊讶地发现,由等份的岩藻糖基化寡糖(例如2’FL)、N-乙酰基化寡糖(例如LNnT)和唾液酸化寡糖(例如6SL)组成的寡糖掺合物显著地增加了乳酸细菌(例如双歧杆菌属)的代谢活性,正如通过乙酸根的形成所看到的那样(图1)。
所述寡糖掺合物还刺激了细菌的生长(图2)。
图1给出了实验结果,其显示了在不具有另外的碳水化合物的情况下或者在具有另外的葡萄糖(Glc)或乳糖-N-新四糖(LNnT)或2’岩藻糖基乳糖(2FL)或6’唾液酸乳糖(6SL)或LNnT、6SL和2FL的掺合物的情况下双歧杆菌属(长双歧杆菌亚种婴儿双歧杆菌)在DMEM培养基中的代谢刺激。(n=6;给出了平均值与SEM;给出了通过ANOVA得到的显著性(p<0.01)。注:仅LNnT、6SL和2FL的掺合物显著地刺激了乙酸根的产生。
图2给出了实验结果,其显示了在不具有另外的碳水化合物的情况下或者在具有另外的葡萄糖(Glc)或乳糖-N-新四糖(LNnT)或2’岩藻糖基乳糖(2FL)或6’唾液酸乳糖(6SL)或LNnT、6SL和2FL的掺合物的情况下双歧杆菌属(长双歧杆菌亚种婴儿双歧杆菌)在培养基中的体外生长。(n=4;给出了平均值与SEM;用小写字母显示了通过ANOVA得到的显著性(p<0.02))。
研究模型2:母乳样品的回顾性流行病学分析和2岁以内变应性疾病的发生
方法:
从约52个剖腹产婴儿母亲对的同龄组(cohort),我们分析了早期母乳样品中存在的特定寡糖的量。为了实现这一目的,我们用水将脱脂乳样品稀释10-100倍并且通过装配有CarboPac PA1柱(Dionex)和电化学检测器的HPAEC(Dionex)分析。使用可靠的寡糖标准物进行寡糖鉴定和定量。我们绘制了婴儿的(A)变应性疾病、(B)特应性变态反应、(C)特应性湿疹的不存在或存在对由2FL、LNnT和6SL组成的寡糖掺合物的量(图3)或由2FL、LNnT、LNT(乳糖-N-四糖)、6SL和3SL(3’唾液酸乳糖)组成的寡糖掺合物的量(图4)的图。
图3给出了实验结果,其显示了在剖腹产儿童中2岁以内(A)变应性疾病、(B)特应性变态反应、(C)特应性湿疹的不存在(否)和出现(是)。绘制了母乳中所测定的特定寡糖掺合物的量的图。此处有代表性的寡糖掺合物是2’岩藻糖基乳糖(2FL)、乳糖-N-新四糖(LNnT)和6’唾液酸乳糖(6SL)的总和(显示出了统计学显著性)。
图4给出了实验结果,其显示了在剖腹产儿童中2岁以内(A)变应性疾病、(B)特应性变态反应、(C)特应性湿疹的不存在(否)和出现(是)。绘制了母乳中所测定的特定寡糖掺合物的量的图。此处有代表性的寡糖掺合物是2’岩藻糖基乳糖(2FL)、乳糖-N-新四糖(LNnT)、乳糖-N-四糖(LNT)、6’唾液酸乳糖(6SL)和3’唾液酸乳糖(3SL)的总和。(显示出了统计学显著性)
结果:
我们令人惊讶地发现,当儿童发生变应性疾病时,特定寡糖掺合物在早期乳中较低水平的趋向(图3A,4A)。就特应性疾病且尤其是特应性湿疹而言,我们测定了在其孩子在2岁之前发生这类变态反应的母亲的早期乳中寡糖掺合物的显著较低水平。
Claims (14)
1.组合物,其包含至少一种N-乙酰基-乳糖胺、至少一种唾液酸化寡糖和至少一种岩藻糖基化寡糖,所述组合物用于预防和/或治疗皮肤病症和皮肤疾病,优选特应性皮炎。
2.根据以上权利要求所述的组合物,其中所述的N-乙酰基-乳糖胺选自乳糖-N-四糖和乳糖-N-新四糖。
3.根据以上权利要求中任意一项所述的组合物,其中所述的唾液酸化寡糖选自3'-唾液酸乳糖和6'-唾液酸乳糖,并且优选所述组合物既包含3'-唾液酸乳糖,又包含6'-唾液酸乳糖,3'-唾液酸乳糖与6'-唾液酸乳糖之比优选在5:1-1:2范围内。
4.根据以上权利要求中任意一项所述的组合物,其中所述的岩藻糖基化寡糖选自2’-岩藻糖基乳糖、3-岩藻糖基乳糖、二岩藻糖基乳糖、乳糖-N-岩藻五糖(即乳糖-N-岩藻五糖I、乳糖-N-岩藻五糖II、乳糖-N-岩藻五糖III和乳糖-N-岩藻五糖V)、乳糖-N-二岩藻己糖I、岩藻糖基乳糖-N-己糖、二岩藻糖基乳糖-N-己糖I和二岩藻糖基乳糖-N-新己糖II,并且优选地所述的岩藻糖基化寡糖是2’-岩藻糖基乳糖(2-FL)。
5.根据以上权利要求中任意一项所述的组合物,其中所述组合物还包含至少一种益生菌菌株,所述的益生菌菌株优选是双歧杆菌属和/或乳杆菌属。
6.根据以上权利要求中任意一项所述的组合物,其中所述组合物还包含至少一种益生元。
7.根据以上权利要求中任意一项所述的组合物,其中所述组合物是一段婴儿配方、婴儿配方、第二阶段配方、婴孩食品配方、婴儿谷物配方或成长奶,并且优选地所述组合物是一段婴儿配方。
8.根据以上权利要求中任意一项所述的组合物,其用于健康婴儿和健康幼儿。
9.根据以上权利要求中任意一项所述的组合物,其用于断乳期之前和/或期间。
10.根据以上权利要求中任意一项所述的组合物,其用于预防所述皮肤疾病、特别是特应性皮炎和降低所述皮肤疾病、特别是特应性皮炎的频率和/或发生率和/或严重性和/或持续时间。
11.根据以上权利要求中任意一项所述的组合物,其用于增强皮肤健康和/或用于预防皮肤脱水和/或用于增强皮肤水化和/或用于减轻皮肤的皮疹、粗糙度和/或干燥和/或用于增强对变应原的口服耐受性。
12.包含至少一种N-乙酰基乳糖胺、至少一种唾液酸化寡糖和至少一种岩藻糖基化寡糖的组合物作为合成营养剂用于预防和/或治疗皮肤病症和皮肤疾病、优选特应性皮炎的用途。
13.包含至少一种N-乙酰基乳糖胺、至少一种唾液酸化寡糖和至少一种岩藻糖基化寡糖的组合物作为合成营养剂用于增强对变应原的口服耐受性的用途。
14.根据权利要求12和13中任意一项所述的用途,其中所述组合物是补充剂,其优选以单位剂量形式被提供。
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EP (2) | EP2465507A1 (zh) |
CN (1) | CN104302297A (zh) |
AU (1) | AU2011340880B2 (zh) |
BR (1) | BR112013011730A2 (zh) |
CA (1) | CA2818011A1 (zh) |
CL (1) | CL2013001436A1 (zh) |
ES (1) | ES2616957T3 (zh) |
IL (1) | IL226049A0 (zh) |
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MY (1) | MY160894A (zh) |
PH (1) | PH12013500892A1 (zh) |
PL (1) | PL2643004T3 (zh) |
RU (1) | RU2609838C2 (zh) |
SG (1) | SG190079A1 (zh) |
TW (1) | TW201300111A (zh) |
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JP2019510036A (ja) | 2016-03-31 | 2019-04-11 | ゴジョ・インダストリーズ・インコーポレイテッド | プロバイオティクス/プレバイオティクス有効成分を含む清浄剤組成物 |
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CN114401642A (zh) * | 2019-09-18 | 2022-04-26 | 科汉森母乳低聚糖股份有限公司 | 含有人乳寡糖的谷物组合物 |
Also Published As
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IL226049A0 (en) | 2013-06-27 |
WO2012076321A1 (en) | 2012-06-14 |
RU2609838C2 (ru) | 2017-02-06 |
AU2011340880A1 (en) | 2013-05-23 |
ZA201304638B (en) | 2016-02-24 |
MX341684B (es) | 2016-08-30 |
MX2013005725A (es) | 2013-07-03 |
TW201300111A (zh) | 2013-01-01 |
MY160894A (en) | 2017-03-31 |
AU2011340880B2 (en) | 2017-03-02 |
BR112013011730A2 (pt) | 2016-08-16 |
US20130251682A1 (en) | 2013-09-26 |
CA2818011A1 (en) | 2012-06-14 |
EP2643004B1 (en) | 2016-12-21 |
SG190079A1 (en) | 2013-06-28 |
US8771674B2 (en) | 2014-07-08 |
PL2643004T3 (pl) | 2017-07-31 |
CL2013001436A1 (es) | 2014-02-14 |
ES2616957T3 (es) | 2017-06-14 |
PH12013500892A1 (en) | 2013-07-01 |
RU2013128594A (ru) | 2014-12-27 |
EP2465507A1 (en) | 2012-06-20 |
EP2643004A1 (en) | 2013-10-02 |
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