CN101400344A - 用于改善细胞的膜组成和功能的组合物 - Google Patents
用于改善细胞的膜组成和功能的组合物 Download PDFInfo
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- CN101400344A CN101400344A CNA200680051656XA CN200680051656A CN101400344A CN 101400344 A CN101400344 A CN 101400344A CN A200680051656X A CNA200680051656X A CN A200680051656XA CN 200680051656 A CN200680051656 A CN 200680051656A CN 101400344 A CN101400344 A CN 101400344A
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Abstract
现在已经发现在对患者或处于形成这种疾病危险的人给予一种保健或药物组合物之后,这些人的健康得到改善,其中该保健或药物组合物包含:a)脂质成分,包括二十二碳六烯酸、二十二碳五烯酸和二十碳五烯酸中的至少一种;b)蛋白质成分,包括来自非人源的提供至少半胱氨酸和/或牛磺酸的蛋白质性质的材料;以及c)矿物质成分,包括锰和钼中的至少一种。哺乳动物细胞的多种类型的膜功能得到改善,这允许有效治疗免疫相关紊乱,如变应反应、自身免疫疾病、癌症、认知功能障碍和神经系统的其它疾病,神经病例如糖尿病性神经病变和神经性疼痛、胰岛素抵抗期间的神经元损伤,以及肠道疾病,并支持在成长或恢复期间的肠道和肺功能的形成。
Description
技术领域
本发明涉及保健(nutraceutical)和药物组合物,更具体地,涉及可改善细胞的膜组成和功能并通过其改善整个细胞功能的组合物。
背景技术
已知活细胞内的膜具有多种重要功能。质膜作为对细胞外组分(例如化学化合物、抗原和细胞)的屏障而发挥作用;膜(细胞内以及质膜)调节组分从细胞或细胞器的外面运送至其内部,反之亦然。膜形成用于多种内源性反应的基质,例如多种对化合物的生物合成、同化作用(新陈代谢)或异化作用重要的酶控反应。膜对外界信号的识别和调制也非常重要,从而促进生物体的恰当反应。与外界的相互作用包括宿主细胞与外来细胞或其部分如抗原/变应原的相互作用、宿主细胞与信号分子如胰岛素、趋化因子、细胞因子和激素的相互作用、以及宿主细胞彼此之间的相互作用例如神经细胞之间的相互作用,特别是中枢神经系统(脑和脊髓内)内神经细胞之间的相互作用。
本领域中,有多篇论文揭示了活细胞与细胞外信号相互作用的方式的特定方面。膜内靶蛋白的磷酸化,其可在受体与细胞外配体分子结合后发生,对信号转导的类型和强度显得比较重要。信号分子复合物与特异性细胞内或膜结合蛋白的组装也同等重要。这些蛋白例如调节蛋白或支架蛋白可包含一个或多个特定结构域如SH2、SH3、PTB以及PTZ和WW结构域类型(参见G.Cesarini et al.(eds):Modular Protein Domains.Wiley VCH Verlag,2004)。细胞对外界信号的反应还依赖于膜的性质。尤其是,某些磷脂酰肌醇(PI)相关的化合物的存在似乎对由含血小板-白细胞C激酶底物(普列克底物蛋白,pleckstrin homology)同源(PH)结构域的蛋白质如蛋白激酶C(PKC)实现功能非常重要。
活细胞对细胞外信号发生反应的方式变化很大,并且包括特异性激活磷脂代谢、特异性细胞粘附行为、GTP酶活性的变化、蛋白激酶活性如PKC的活性的局部化、特异转录因子的表达、胰岛素受体敏感性以及受体和离子通道空间排布或活性的调节。
神经细胞(神经元)之间的相互作用需要激活离子通道,包括Na+、K+和Ca2+通道。此外,受体数目的调节以及与不同类型受体相关的调节对于恰当的认知、情绪和感觉运动(如听觉、嗅觉、触觉和味觉)功能非常重要。这种调节还可由神经调节蛋白(Nrg-1)和突触后密度蛋白(PSD-95)介导,这些蛋白的功能似乎依赖于膜组成。最后,信号转导将导致各种特异基因的激活,它们一起调节意识、行为以及认知和智力。
除水之外,细胞膜包含多种类型的化学组分,如磷脂类、胆固醇、糖脂类、鞘脂类、硫苷脂、脑苷脂类、神经节苷脂、蛋白包括糖蛋白、肽、离子、维生素和多种其他组分。通常,这些组分并非在膜上平均分布,可鉴别出极性和非极性区域。特别地,对于所谓的“筏蛋白”(常为质膜内的小的非极性区域)而言,已经赋予了特定的功能(Brown,D.A.,London,E.,(2000)J.Biol.Chem.275:17221-17224)。
由于物理和/或酶促过程,膜组成可随时间发生许多变化。膜样结构(membrane-like structures)还形成高尔基体和内质网(ER)的大部分,并且它们的结构决定了其可能的功能和性能。
人们已经阐述了几种影响神经细胞之间的相互作用并改善认知功能的方法。
US 2005/0009779披露了一种可增强膜流动性并以该方式增强受体功能的方法。据称,饱和脂肪酸和胆固醇使膜变硬,并且长链多不饱和脂肪酸与某些可改善蛋氨酸代谢的组分的组合可使细胞膜以更好的方式发挥作用。关于除磷脂外的极性膜组分存在的重要性以及关于食物组分如锰、钼、牛磺酸、半胱氨酸、硫酸盐、水的作用以及合适营养产品中用于改善膜功能的碳水化合物部分的性质,该文献未作陈述。
US 2005/0203053披露了可通过增强脑内磷脂的生物合成而改善神经系统功能。这可通过食用尿苷源(uridine source)、胆碱源(asource of choline)以及可选的脂肪酸而实现。据称突触传递被改善;神经突的数量以及P2Y受体的敏感性增加。US 2005/0176676中也披露了这些食物组分的类似作用。
WO 2004/028529披露了一种用于改善认知功能的特定磷脂,包含花生四烯酸的特殊磷脂,可选的,结合中链甘油三酸酯或一种二十二碳六烯酸源。
WO 2005/051091披露了一种甘油磷脂与(神经)鞘磷脂和/或胆固醇的特定混合物,该混合物类似于人母乳,以脂肪球的形式存在,用于生产婴儿制品。据称该混合物对胎儿、婴儿和儿童的认知和视觉功能的形成有好处。
已经有人提议将特定的脂质混合物用于治疗疾病或改变生物体的功能。
EP 1279400中披露了一种等张脂质乳剂,其包含60-95wt%MCT和5-40wt%鱼油,并且不包含植物油。据称该脂质混合物可迅速改变器官和组织的细胞膜,对于多种疾病的治疗有用。
EP 0311091披露了一种胃肠外应用的特定脂质混合物,其包含MCT、ω-3和ω-6脂肪酸、一种磷脂成分以及维生素E。据称这种脂质混合物对于经受手术、多处创伤、烧伤、感染、肺衰竭和慢性炎性疾病的患者有用。如所披露的,所述产品不包括完整的蛋白或肽,不适于完全营养。
EP 0484266披露的营养产品包含DHA和EPA、约24-约82mg磷脂/每升产品以及核苷酸混合物,据称其对养育婴儿以及肝硬化和腹泻的饮食管理有用。
EP 1426053披露了磷脂、(神经)鞘磷脂或半乳糖脂在药物组合物的制备中的应用,所述组合物在胃肠外使用用于抑制肿瘤细胞粘附、抑制转移细胞的粘附和/或抑制肿瘤转移灶的生长。已提出的配方不适于肠道途径的完全营养,但未指出其他食物成分可能以何种方式干扰所称的效能。
多篇论文研究了二十碳五烯酸(EPA)或二十二碳六烯酸(DHA)对治疗炎性疾病的有效性。然而,在表明给予这些ω-3脂肪酸的临床效果方面出现了严重困难。直至提交日期,主要在关节炎的治疗中观察到了统计学显著性改善。
本发明的一个目的是以一种方便,尤其是通过给予美味的肠内配方的方式来改变多种类型细胞中的细胞膜(尤其是筏蛋白)的组成。
发明内容
一方面,本发明涉及一种脂质成分,其包括至少一种选自由二十二碳六烯酸(DHA)、二十二碳五烯酸(DPA)和二十碳五烯酸(EPA)组成的组中的组分,该脂质成分进一步包括至少一种选自糖脂的组的组分,用于改善免疫功能、调整宿主细胞与抗原、变应原、趋化因子、细胞因子、其他宿主细胞和/或胰岛素之间的相互作用或者调整Th1与Th2细胞的数量的比值。
特别地,该脂成分可以为营养、保健或药物组合物或它们的一个组分。
因此,一方面,本发明现提供一种营养、保健或药物组合物,其包括至少一种选自由二十二碳六烯酸(DHA)、二十二碳五烯酸(DPA)和二十碳五烯酸(EPA)组成的组中的组分,该脂质成分进一步包括至少一种选自糖脂的组中的组分。
一方面,本发明现提供一种保健或药物组合物,其包含:
a)脂质成分,包括二十二碳六烯酸(DHA)、二十二碳五烯酸(DPA)和二十碳五烯酸(EPA)中的至少一种;
b)蛋白质成分,包括非人来源的蛋白质性质的物质,其提供至少半胱氨酸和/或牛磺酸;以及可选地
c)矿物质成分,包括锰和钼中的至少一种。
根据本发明(使用)的一种组合物优选每100g包括从约50至约120kcal的热量。
在一种实施方式中,根据本发明(使用)的组合物进一步包括核苷酸成分,选自由碱基如尿嘧啶、胞嘧啶、腺嘌呤、鸟嘌呤、胸腺嘧啶、它们的磷酸化形式(核苷酸)特别是单磷酸化形式例如一磷酸尿苷,还有腺苷和鸟苷以及其他核苷组成的组。
可选地,所述组合物进一步包括可消化性碳水化合物成分,优选包括半乳糖和/或核糖源(a source of galactose and/or ribose)。
优选地,脂质成分来自乳品来源(dairy origin)、来自蛋类(egg)或者来自植物种子或豆类的胚乳(the endosperm of plant seeds orbeans),且其优选包括大小为0.001-10μm的脂肪球。
在详细说明和实施例中示出了所述组合物的具体实施方式。
还提供了根据本发明的一种组合物在自身免疫疾病等疾病中用于改善哺乳动物细胞(所述哺乳动物细胞选自由神经细胞、免疫细胞、干细胞、骨髓细胞和红细胞组成的组)的功能、用于改善哺乳动物的记忆功能、用于刺激哺乳动物的免疫功能、用于预防哺乳动物肥胖的应用。
所述组合物用于制造某些药剂也是本发明的一部分,所述药剂用于治疗痴呆如阿尔茨海默(氏)病、神经病变、免疫功能低下(depressed immune function)、变态反应、贫血、肥胖、糖尿病、自身免疫疾病、心律失常、心脏衰竭、肿瘤、COPD、支气管炎、关节炎、肝炎、慢性炎症、血脂异常和类风湿病。
附图说明
图1证实了当将根据本发明的产品供给大鼠(被注射了Aβ)时,乙酰胆碱的生物合成和转运的显著改善。
具体实施方式
现在已发现特定的食物组合物(也称为保健品组合物)或药物组合物可改善活细胞的功能。
根据本发明的产品包含脂质成分,其包括二十二碳六烯酸(DHA)、二十二碳五烯酸(DPA)和二十碳五烯酸(EPA)中的一种或多种。特别地,该产品进一步包括一种或多种糖脂,用作营养、保健或药物组合物,用于改善免疫功能、调整宿主细胞与抗原、变应原、趋化因子、细胞因子、其他宿主细胞和/或胰岛素之间的相互作用或者调整Th1与Th2细胞数量的比值。
优选地,根据本发明的产品进一步包括蛋白质成分(后者提供半胱氨酸和/或牛磺酸等价物)以及可选的矿物质成分(其包括锰和/或钼)。可选地,还可有益地包括可消化的碳水化合物成分和/或核苷酸源(nucleotide source)。
优选脂质成分提供的能量比制品中可消化组分所提供的能量多30%,所采用的计算因子(calculation factor)为9kcal/克脂质、4kcal/克蛋白或克可消化性碳水化合物、产品中的其他组分为0kcal。优选地,该产品包括的脂质含量为总能量含量的32-80%,更优选33-60%,甚至更优选36-50%。
脂质成分的量可通过应用本领域中已知可适用于测量食物基质中脂肪含量的方法而测定。例如,一般食物中的脂肪含量通过应用法定方法983.23而测定,而Roese-Gottlieb方法(932.06)则更适用于基于干燥奶粉的产品(Lehner,R.,Estoppey,A.,(1954)Mitt.Lebensmitteluntersuchung Hyg.54:183-185),还有其他方法可用于测定婴儿制品或临床营养品中的脂质含量。
各个组分的量可通过应用特别设计用于测定该特定组分的方法或通过如在983.23法中所给出的分馏从氯仿-甲醇(分馏)馏分的提取物中分离出来的脂肪成分。如果两种公认的方法出现统计学显著性差异(采用P=0.05),则采用获得最高值的方法。脂质成分可包括甘油三酯、甘油二酯、甘油一酯、磷脂、溶血卵磷脂、糖脂、固醇和其他脂溶性组分。为了本申请的目的,将脂质成分(而非碳水化合物成分)定义为包括硫苷脂、脑苷脂、神经酰胺、神经鞘脂、(神经)鞘磷脂、神经节苷酯和糖脂如红细胞糖苷脂、血糖苷脂及乳糖酶基(神经)鞘氨醇。本领域中,用来测量食物基质中这些组分的量的具体分析方法已经为人所知。因此,应将这些量增加至如由其他测定总脂肪的方法所测得的量,只要它们不包括在那些测定值中。
所述组合物的极性组分似乎具有乳化性能,其可能干扰在均质液体制品的生产中常规使用的乳化系统,该液体制品进一步包含蛋白、可消化性碳水化合物以及可选的矿物质成分,含量与本发明一致。通过利用乳质(milk fractions)成分作为这些糖脂和糖蛋白的来源,适合于完全肠内营养的液体形式产品保持均质。
总脂质成分包括ω-3系列的长链多不饱和脂肪酸(链长度至少为18(个碳原子),并简写为LCP),尤其是DHA、EPA和DPA中的一种或多种。这些脂肪酸可以甘油三酯、磷脂、神经鞘脂类、糖脂或其他食物级别形式存在。对于成人,ω-3LCP的量必须大于400mg/份,每天提供400-3300mg剂量的这些脂肪酸。脂质成分中DHA、EPA和DPA总和的浓度为脂质成分的2-50%,优选5-45%,更优选20-40%。液体产品中EPA、DHA和DPA总和的浓度为最低0.2mg/ml至最高15mg/ml,优选0.3mg/ml-12mg/ml,更优选0.4-11mg/ml。对于婴儿,ω3LCP的量通常应该大于30mg/份,从而每天提供30-1000mg剂量的这些脂肪酸。
在一个具体实施方式中,本发明的一种组合物每100g包括:
a)1000至2000mg的DHA+DPA+EPA+糖脂;
b)30-80mg半胱氨酸+牛磺酸
c)0.3-2mg锰+钼
相比脂质成分中其他组分的量,脂质成分通常包含相对较低量的ω-6系列的长链多不饱和脂肪酸。比值ω-3/ω-6通常在0.3-5的范围,优选0.4-4,更优选0.5-2。该配方中,ω-6LCP的量将低于脂肪酸的50wt%,优选5-40wt%,更优选8-30wt%,最优选8-20wt%,尤其优选8-15wt%。
优选地,还包括饱和脂肪酸。这些饱和脂肪酸包括那些链长度为8-24个碳原子的脂肪酸。优选地,这些脂肪酸包括那些含10、12、14和16个碳原子的脂肪酸。饱和脂肪酸(如果存在)的量通常应该占脂质相重量的6-60%,优选10-40%,更优选12-36%。尤其是,C14:0+C16:0的量通常应该占脂质相的6-60wt%,优选10-40wt%,更优选12-36wt%。中链甘油三酯可来自所谓的MCT油,或来自椰子油或其他恰当来源。MCT的量通常应该为脂质成分的1-60wt%,优选3-40wt%。肉豆蔻酸和软脂酸(棕榈酸)可以作为酸、其盐、以及与烷基或酰基形成的酯(如在甘油酯中)或以其他恰当形式而包含在内。优选它们以甘油三酯包含在内,例如棕榈仁油或结构化甘油三酯(具有一个额外的ω-3LCP)中存在的,或者以甘油二酯或甘油一酯的形式而包含在内。优选包含饱和脂肪酸的甘油一酯或甘油二酯,因为当包含较高量的脂质时,相比于甘油三酯形式,其看起来可提供技术优势。
油酸(C18:1)优选存在于脂质相。其应该以脂肪酸的5-40wt%、优选6-35wt%、更优选8-34wt%的含量存在。液体制品中的含量将处于0.1-2g/100ml液体产品,优选0.15-1.2g/100ml液体产品,更优选0.2-1.0g/100ml液体产品的范围。
可选地,脂质成分的一个重要部分将包括复酯(complex lipid)如糖脂,如神经鞘脂类如神经鞘氨醇(例如(神经)鞘磷脂)、酸性神经鞘氨糖脂如硫苷脂类和神经节苷脂以及红细胞糖苷脂。在总脂质成分中,除甘油三酯和磷脂之外的物质的量优选大于0.01wt%,优选0.015-1wt%,更优选0.02-0.5wt%。糖脂的量优选至少为脂质成分的0.1wt.%,尤其是0.1-20wt.%。为了得到最佳结果,(神经)鞘磷脂的量优选应该大于130微摩尔,优选135-3000微摩尔,更优选140-2000微摩尔,而酸性神经鞘氨糖脂的量优选应该大于0.003wt%,优选0.005-0.5wt%,更优选0.008-0.4wt%。神经节苷脂的量应该大于7mg/l液体产品,优选8-80mg/l液体产品,更优选9-40mg/l液体产品,特别是9-25mg/l液体产品。优选的神经节苷脂是GD3和GM3。
这些化合物可在能够从微生物如酵母、细菌中分离出来的成分中找到,或在真菌、藻类植物和动物材料如蛋类、神经组织、成纤维细胞和乳类中找到。优选采用食物级成分。特别地,优选采用来自乳类的成分,例如包含高水平脂肪球的提取物。这些成分可从酪乳制造(manufacture of buttermilk)中获得,尤其是可在从酪乳(buttermilk)生产乳酪(cheese)后剩余的乳清(whey)中得到。可购得的合适产品包括“酪乳粉末”和“奶油乳清”。
乳清包括相对较大量的小脂肪球,特别在已经去除了巨大蛋白如β-乳球蛋白的情况下。可通过对脱脂产品施加过滤技术而增加小脂肪球的浓度,该技术浓缩在膜一侧上的脂质层并去除诸如盐和乳糖的分子。该产品称为“乳清微滤渗余物”。富含酸性神经鞘氨糖脂的成分还可通过应用本领域中已知的层析法如离子交换而分离。
来自多种哺乳动物的乳(milk)适合用于分离活性组分,然而,来自母马、绵羊、山羊和骆驼的乳特别合适。最优选采用从绵羊乳分离的脂质提取物。
绵羊乳中的脂质含量应该大于脂质成分的5wt%,优选8-60wt%,更优选10-40wt%。
例如,来自蛋类、大豆、初乳、骨髓、脑、乳,特别是富含脂肪球的酪乳,并且尤其这些脂肪球的膜是人们特别感兴趣的,以包含入根据本发明的产品中。这些成分被浓缩在复合糖脂中,该复合糖脂还包括相对较高浓度的不同于葡萄糖和果糖的碳水化合物。这些成分可通过利用本领域中已知的方法如己烷提取或离心将原始成分脱脂而分离。还应对残留的脂质或水性成分应用其他方法,以提取以脂肪球膜形式存在的较高极性脂质成分。恰当的方法包括选择性去除分子量低于300的化合物如矿物质和乳糖或者例如通过采用过滤、吸附、层析、渗透技术或沉淀而去除所选蛋白质。
特别地,尺寸较小的脂肪球,尤其是那些直径小于4.0μm,优选小于3.0μm,更优选0.001-2.0μm,最优选0.01-1.8μm的脂肪球包含感兴趣的组分。在其中例如由于脂肪酸分布不恰当而乳脂不合乎患者的需要的那些情况下,则优选除去至少部分的尺寸较大的脂肪球,特别是直径大于4.0微米的脂肪球。
因此,来自乳类的脂质成分应该优选包含大于1%,更优选1.2-2.0wt%,最优选1.3-16wt%的磷脂。此外,脂质成分应该优选包含0.1-20%,更优选0.2-10wt%,最优选0.6-8wt%的糖蛋白和糖脂,并优选包含0.2-10wt%,更优选0.3-9wt%,最优选0.35-8wt%的胆固醇或胆固醇酯。优选地,从乳类分离的脂质成分包含增加量的磷脂、糖蛋白、糖脂和胆固醇中的至少两种,更优选所有组分的的含量均高于乳脂中含量。
最终产品中的脂质组成优选包含乳成分(富含不同于甘油三酯的组分,并且相比于天然材料的脂质成分中的含量,尤其包含50%更多的来自乳类的较小脂肪球膜的糖脂和/或糖蛋白)的1-80wt%,更优选2-50wt%,最优选3-40wt%。
用于从乳制品中分离富含在脂肪球中的成分的恰当方法,可在US 6,824,809中查到,该专利通过引用结合于此。US 6,391,362也披露了一种从乳类或乳脂的脂质成分中分离脂肪球成分的恰当方法。然而,优选从其中分离尺寸较小的脂肪球,例如通过对第二水相施加微滤。优选不磷酸化脂肪球的初始组分。
另外的用于从乳类中提取恰当较小脂肪球的优选方法是微过滤在生产黄油(butter)、松软干酪(cottage cheese)或酸奶酪(quark)后得到的水相。特别是绵羊乳、山羊乳和骆驼乳是用于分离根据本发明所述脂肪球成分的恰当来源,即使它们的脂肪球成分与人乳汁中脂肪球成分存在相当大程度的差异。已经根据所述方法分离的脂肪球成分似乎没有可能的干扰性物质如朊病毒(感染性蛋白质,prion)、病原体或病毒。
尽管来自所述成分的脂肪球或其部分均高度有效,但是它们在根据本发明的终产品的制备过程中或保质期中无需保持完整。在加工过程中应用匀质步骤并包含入可导致终产品有效的成分如蛋白质成分或其他脂质组分,可与所述成分中存在的初始脂肪球相互作用。因此,通常产品中脂肪球的尺寸将增加,并且超过50%的脂质成分将作为大于2微米的脂肪球并以非脂质体形式而提供。体积超过90%的脂质成分将以直径大于0.025μm的小球而存在。
终产品的脂质成分每100ml液体产品优选包含大于0.56g的长链多不饱和脂肪酸,更优选0.57-3.1g,最优选0.57-2.8g,特别的0.57-1.4g。
在半固态或固态产品中的浓度未明确提及或者不能直接从已公布的的每日分配日剂量中得到的那些情况下,它们可最后通过校正干质量百分比,而从所主张的液体产品中活性成分的浓度计算得到,假设每100ml液态产品中干物质(dry mass)含量为15g,每100g半固态产品中为35g,以及每100g固态产品中为90g。
在营养不良的个体中,在每日剂量中包含0.1-10g,优选0.2-5g胆固醇源(cholesterol source)比较有益。胆固醇的恰当来源包括胆固醇、其盐和酯。这些营养不良的患者可以为住院患者、经受蛋白-能量营养不良的患者以及老年人。长期采用不良用餐方式的营养不良个体不包括在该组患者中,其中,长期尤其意味着食用相对较大量的反式脂肪酸和多不饱和脂肪酸特别是植物油(其已被氧化)达数月。
矿物质成分至少包括锰或钼,可选地,可添加镁和锌。优选锰和钼均包括在内,更优选还包括有效量的镁。
饮食中包含锰似乎对于改善细胞的膜功能特别是神经细胞的膜功能比较重要。特别是营养不良个体或者患遗传病或代谢失调的个体已经赋予用于产生(神经)鞘磷脂和/或相关化合物如硫苷脂和糖基化神经酰胺的代谢能力。此外,在这些失调的过程中以及快速成长的过程中,会出现个体对这些化合物生物合成的需求增加。这些个体的实例是患神经疾病如阿耳茨海默(氏)病、帕金森病、抑郁、ME的患者,患系统性红斑狼疮(SLE)、由神经损害或脊髓损伤引起的偏瘫的个体,还包括处于神经组织发育期的婴儿和胎儿以及孕妇。
对于体重80kg的个体,每日给与/食入的锰量应该大于7mg,优选9-300mg。液体产品中的浓度可例如通过采用日体积并计算日剂量与日体积的比值而计算。假设例如每管饲体积2000ml提供的锰浓度为至少7/2000ml=350mg/100ml。我们还假设每ml管饲的热量密度为1.0kcal或4.2kJ。因此,每100kcal的浓度最低是0.35mg/100kcal,优选0.45-15mg/100kcal或>0.83mg/100kJ,优选0.107-3.6mg/100kJ。
对于体重3kg、能食入400ml的婴儿,该最低浓度是0.065-mg/100ml。因此,对于能量密度0.67kcal/ml的婴儿制品,该浓度将大于约0.1mg/100kcal。
已发现如上所述包含锰对消化道内乳酸杆菌的生长具有促进作用,与该作用相关的几个好处可在该有益作用之后发生,包括腹腔pH的下降、消化道内病原菌生长减少以及免疫功能的强度和/或能力增加(根据感染率下降和/或腹泻减少而测得)。而且可观察到粪便稠度改善,特别是便秘的发生频率改善。尽管这些肠道细菌的增加使利用锰增加,但仍可观察到对细胞功能的系统效应,尤其是当给与所给定的浓度时。
为了使辅因子恰当发挥作用,需要额外的钼,所述辅因子似乎对于形成恰当的膜组成例如它们的硫苷脂含量,特别是保证神经细胞的恰当功能很重要。而且,包括恰当量的锰可延缓部分老年人在衰老过程中的脑萎缩。在成熟和发育过程中或者在炎性肠病和/或食物变态反应的过程中也需要锰,以形成恰当的(比如消化道的)屏障功能。
恰当量的钼是指多于2μg/kg体重/天的量,特别是3-40μg/kgbw.d,更优选3.6-32μg/kgbw.d。对于婴儿制品,这通常将得到2.0-40μg/100kcal[或0.48-9.5μg/100kJ]的浓度,优选2.6-30μg/100kcal[或0.62-7.1μg/100kJ],对于成人产品,则将得到15-400μg/100kcal,优选18-100μg/100kcal,更优选24-40μg/100kcal[分别相当于3.6-95mg/100kJ,优选4.3-23.8mg/100kJ,更优选5.7-5.7mg/100kJ]。
对于体重80kg的人,每天食入锰的量应该为400-1000mg,优选480-800mg。当设计为完全营养时,这将得到的浓度为7.5-40mg,优选9-30mg/100kcal,相当于1.8-9.5mg/100kJ,优选2.1-7.1mg/100kJ。镁对于糖脂的足量生物合成比较重要。
为了实现几个目的(例如为了使铜的稳态正常化),可额外添加锌。为此,相对于铜,应该以8-40倍优选10-30倍的比值提供过量的锌。铜稳态的正常化对于增加含铜血浆铜蓝蛋白的饱和度以及防止膜成分包括APP或其部分的过度氧化均比较重要。
具有平衡的矿物组成似乎比较重要,这增强了每个患者的效果,也增加了在较大群患者中的适用性。这方面的平衡意味着如上文提及的所有矿物质均应该包括在内,同时如所指出的,相对量对于形成恰当的平衡也非常重要。
这些矿物质的恰当来源包括它们的含有有机或无机阴离子的盐如硫酸盐、碳酸盐、碳酸氢盐、氢氧化物、氯化物和柠檬酸盐。不应采用锰和钼的氧化物,尤其在婴儿制品中。优选采用某些硫酸盐形式,使得该硫酸盐提供1-400mg/100g产品,优选2-250mg/100g产品,更优选3-125mg/100g产品。钼适合作为钼酸盐包含在内。
当产品内包含大量钙或者在总日常饮食中使用大剂量钙(例如,除了根据本发明所述产品,还食入大量营养补剂)时,锰和钼的作用可被拮抗。因此产品中钙量/锰量应为1-235:1,优选5-205:1,更优选10-100:1。
产品中包含的蛋白质成分必须超过80wt%,优选90-100%是可消化的。所述蛋白质成分包括完整蛋白、肽(如可通过完整蛋白水解和通过合成而得到的)、肽衍生物(包含超过80%重量的氨基酸)、(天然存在的)氨基酸本身和牛磺酸以及所述氨基酸和牛磺酸的衍生物如盐、N-酰化或N-乙酰化形式以及酯。甜菜碱、二甲基甘氨酸、肌氨酸、核苷物质以及胆碱也包含氮,但并不计算为蛋白。
蛋白是由于提供可利用的半胱氨酸和/或牛磺酸等价物。通常用于食物制造中的所有蛋白均提供半胱氨酸。如果考虑将乳品作为蛋白源,则应该认识到酪蛋白是相对较差的半胱氨酸来源。因此,为了增加产品中的半胱氨酸水平,使用至少部分的乳清蛋白,特别是α乳白蛋白或者富含在α乳白蛋白中的乳清蛋白比较有益。相比于在天然乳类中观察到的比值相关的α乳白蛋白的量,优选相对较低的β乳白蛋白的量。
当采用乳类(milk)作为蛋白源时,优选使用富含于蛋白或肽(其糖基化程度较高,如酪蛋白糖巨肽(CGMP))中的蛋白质成分。将这些蛋白/肽定义为其中超过10%的氨基酸残基已经被糖基化的那些肽。乳类(用于包含入蛋白质成分中)的成分中CGMP的量蛋白质成分优选大于20%,更优选大于35wt%,最优选大于40wt%。
优选蛋白包含的组氨酸浓度为2.5g/100g蛋白,优选3.0-6g/100g蛋白,更优选3.3-6g/100g蛋白。这意味着当采用乳清蛋白达到相当程度时,需要包含游离组氨酸。
牛磺酸的含量应该大于0.1g/每日剂量,优选0.2-4g/每日剂量,更优选0.4-3g/每日剂量。通常该剂量所得到的液体产品中浓度大于5mg,优选7-100mg/100g产品,更优选9-60mg/100g产品。牛磺酸盐也是合适的成分。
除了上述脂质、矿物质和蛋白质成分,本发明的组合物优选包括其他成分,例如碳水化合物成分和/或核苷酸成分。此外,优选还包括维生素成分和/或甲基供体成分。
碳水化合物成分包括可消化性碳水化合物成分,其优选包括半乳糖和/或核糖源。为了在升糖指数(glycemic index)较低的碳水化合物混合物中提供足够能量,这些可利用且可消化的非葡萄糖类的量必须低于消费者可利用葡萄糖量的50wt%,优选10-40wt%。半乳糖或核糖的恰当来源是二糖如乳糖或食物级质量的合成单糖。尽管来自核苷酸的核糖促进该产品的生理效应,但由于产品中核苷酸剂量相对较低,所以文献中未将其计算为对总核酸糖含量有贡献。
可消化性碳水化合物成分有益地包括葡糖胺如甘露糖胺和半乳糖胺或者其N-酰化形式例如N-乙酰化形式,含量为可消化碳水化合物成分的0.1-10wt%,优选0.2-6wt%。
碳水化合物的一部分,特别是2-50wt%,可以有益地为糖醛酸,如已经在申请EP 5103247.2中描述的。低聚糖的一部分,其已经在WO 2005/027663中披露过,对于下文提及的应用也是有效的,特别是当与已公布的蛋白质成分以及矿物质成分联合使用时。
碳水化合物成分优选还包括肌醇源(a source of inositol)。内消旋肌醇是优选的形式,尽管允许达50%的可来源于磷酸化形式例如植酸等价物如植酸盐。磷脂酰肌醇似乎也是一种恰当的选择。
每天应该给予体重80kg个体的肌醇等价物的量为0-1500mg,优选320-1200mg,更优选380-1100mg,最优选420-1000mg。当计算体重4kg的婴儿每日所需剂量时,得到的结果为21-50mg。
包含于该制品中有益的其他成分包括核苷酸源。核苷酸源是那些食用后可引起体内黄嘌呤、核苷酸、核苷和/或核酸碱基的组织水平升高的成分。恰当的成分包括核酸碱基如尿苷、胞苷、腺嘌呤、胍、胸苷、它们的磷酸化形式特别是单磷酸化形式例如一磷酸尿苷;以及腺苷和鸟苷、核苷和核苷酸。
尽管通过给予单一核苷酸源特别是一磷酸尿苷(UMP)可观察到有益效果,但是对于所声称的组合物的组分,可通过利用核苷酸、核苷或核酸碱基的混合物获得大致相当的良好效果,同时没有人体不希望的副作用风险。这种混合物优选从酵母或动物组织提取。
当UMP作为来源时,对于体重80kg的人来说,每日剂量的量必须达到0.08-3g,优选0.1-2g,更优选0.15-0.9g。基于体重的所需等价物的剂量可通过采用等摩尔的核酸碱基并校正分子量,利用UMP的分子量(约324道尔顿),而从UMP的剂量计算得到。
尿苷衍生物如UDP,其可很容易从饮食UMP形成,对于细胞内的糖蛋白和糖脂的转运及其在胞浆(细胞溶质)和质膜内的可利用度显得很重要。
特别是在用于儿童或婴儿的食物中,尤其是在婴儿制品中,希望尿嘧啶源(包括游离核酸碱基、核苷(尿苷)以及核苷酸(如UMP、UDP和UTP))与其他核酸碱基(包括游离核酸碱基、核苷和核苷酸)总和的比值相对较高,即尿嘧啶源提供大于总核酸碱基源(包括核苷和核苷酸)的25mol%,特别是大于36mol%,优选大于42mol%,尤其至少50mol%。
特别是在用于儿童或婴儿的食物中,尤其是在婴儿制品中,[CMP+UMP]与[AMP+GMP+TMP+IMP]的摩尔比值优选大于1.45,特别是大于1.6,较优选至少1.8,尤其是至少2.0。特别地,该比值可达到200,特别是达到100。
特别是在用于儿童或婴儿的食物中,尤其是在婴儿制品中,UMP与[AMP+GMP+TMP+IMP]的摩尔比值优选大于0.36,特别是大于0.42,较优选至少0.5,尤其是至少0.6。该比值通常达到200,特别是达到100。
考虑到现有用于婴儿制品的食品法规,特别的,在婴儿制品中,UMP浓度可以在0.1-0.42mg/100kJ的范围,和/或核苷酸的总量可在0.1-1.2mg/100KJ的范围。
为了改善效果,认为包含浓度为0.42-10mg/100kJ,特别是0.5-10mg/100kJ的UMP比较有益。特别是核苷酸的总量可达100mg/100kJ。
维生素成分(如果存在)应该优选包括食物级形式的维生素B6,其能够在体内增加肝和/或脑内磷酸吡哆醛的水平。这意味着对于体重80kg的个体,维生素B6的每日剂量被限制为每天不超过50mg,优选不超过25mg维生素B6。对这样的个体来说,有效剂量是2-50mg,优选2.4-40mg,更优选8-25mg的维生素B6。对于体重不同的人,最适剂量可通过采用成比例部分而计算。例如,对于体重3kg的婴儿,最适剂量是37-1875μg。优选的维生素B6的形式是吡多胺、吡哆醛、3-酰化吡哆醛类似物或其盐,如在US6586414,US 6548519和US 6339085(均结合于此)中所披露的。
维生素成分进一步可包括生物素、叶酸盐和维生素B12。
所包含生物素的量应该大于1.5μg/kgbw.d,优选4-50μg/kgbw.d,更优选5-40μg/kgbw.d。对于成人,通常这样导致的产品中生物素的浓度大于6μg/100kcal,优选7-60μg/100kcal,更优选8-40μg/100kcal,而对婴儿则>3,优选4-50μg/100kcal,更优选4.6-30μg/100kcal。生物素的恰当来源在本领域中已经为人所知。
叶酸盐包括叶酸、甲酰四氢叶酸、叶酸盐的甲基化、亚甲基化和甲酰基化形式的叶酸、它们的盐或酯,及具有一个或多个谷氨酸的衍生物和所有的还原或氧化形式。对于体重80kg的成人,如果计算为叶酸量,则该量应该达到至少300μg,优选420-2000μg,更优选520-1500μg/日剂量。对于婴儿,每kg体重建议的叶酸量比成人稍高。其应该>10μg叶酸/kgbw.d,优选30-140μg/kgbw.d,更优选45-120μg/kgbw.d。
所述制品的一个优选实施方式包括维生素B12。特别地,该维生素B12不是(氰)钴胺素,而是一个选自羟基钴胺素或甲基钴胺素的成员或者如WO 02/087593中披露的硫醇钴胺素(thiolatocobalamines)之一或如US 6187761所披露的提取物。
其他维生素例如维生素A,D,E,K,C,B1,B2,B3和泛酸以及矿物质和痕量元素例如Na,K,Ca,Fe,Cu,Se,I,F,符合营养需求的常规推荐,特别是在婴儿制品中。
此外,甲基供体优选包含于根据本发明所述的产品中。当在哺乳动物体内被吸收时,甲基供体能够产生至少一个甲基。恰当甲基供体的实例包括甜菜碱、胆碱、丝氨酸、二甲基甘氨酸和肌氨酸。为了得到有效的结果,优先选择甜菜碱或二甲基甘氨酸。当蛋白源包含20wt%以上的植物源蛋白例如来自谷类(如小麦、燕麦、大米、玉米或大豆)或者种子/根茎类如豌豆、白羽扇豆、土豆或蚕豆的蛋白时,在产品中包括额外的甲基供体的优点变得尤其明显。这些产品中的有效剂量大于0.18mmol/kg体重/天剂量,优选0.19-2mmol/kgbw.d,更优选0.2-1.2mmol/kgbw.d。为了标准化,如果将人体重设为70kg,这将意味着胆碱(或二甲基甘氨酸,因为其具有差不多相同的分子量)应该以大于1.3g/2L产品的浓度在液体组合物存在。成人消费者所用液体补充物(量为400ml/d)则将包含1.3g/400ml。
来自磷脂的胆碱对甲基供体的量的贡献没有计算。
相比于甲基供体的量,如果产品中的甲基受体的量保持较低,则用一种或多种甲基供体进行的强化特别有益。特别地,相比于甲基受体(例如甘氨酸、磷脂酰乙醇胺,和多胺如精胺及亚精胺)的摩尔量,甲基供体的摩尔数过量3倍有利。
此外,那些产品中可以有利地包含他汀类药物,所述产品可为患血脂异常特别是高胆固醇血症的患者使用。在设想血浆胆固醇水平迅速降低的情况下,混合物在短于2周的时间内将比较有用。在该期间,所述化合物可增加本发明所述组合物的效力。然而,较长时间包含诸如辛伐他汀、洛伐他汀、罗苏伐他汀、普伐他汀、氟伐他汀和阿伐他汀的化合物的不利之处在于它们能够强烈抑制羟甲基戊二酰CoA还原酶(当给予相对较小量时)的能力。因此,如果该产品长期与他汀类一起食用,则该产品应该包含由泛琨、泛醇、维生素K2(menaquinons)、辅酶Q10、多萜醇、多萜醇酯、多萜醇醚、合成的聚类异戊二烯(含8个以上类异戊二烯单元,例如带有一个或多个羧酸基团的类异戊二烯)、具有类视黄醇的羟基、番茄红素和固醇组成的组中的一种或多种,其量应足以抵消给予他汀类的不利之处。优选包含多萜醇或其类似物,其中所述多萜醇类似物分子的至少80%基本为非极性。允许最多15%,但优选少于10%的碳原子可为极性基团例如羟基、烷氧基(特别是甲氧基)、羧基、巯基、取代巯基、氨基、取代氨基、烷基或酰基部分所取代。
这些内含物要求保持产品作为如癌症患者的免疫功能改进剂的效力,特别是作为降低对转移灶形成的敏感性的产品。如果与他汀类疗法联用,则该产品如果在没有权利要求1中所述产品的蛋白质和矿物质成分的情况下使用,仍显得更有益,前提条件是包含上文提及的组分,含量为每日剂量至少20mg多萜醇类似物、至少4mg类视黄醇、至少4mg泛琨、泛醇、甲基萘醌类或维生素K2以及至少0.02mg固醇。恰当的固醇特别是天然固醇,如在哺乳动物有机体中存在的。
效果
根据本发明的产品可使神经细胞的膜功能正常化,特别是当这些膜发生变形和/或组成不当时。尽管人们可以推测这些缺陷的原因,但似乎一种或多种膜结合酶的功能不良例如鞘磷脂酶上调(其降低(神经)鞘磷脂含量并增加神经酰胺水平)似乎对该病症比较重要。而且,暴露于大量的应激原(stressor)、遗传倾向(geneticdisposition)和/或慢性营养不良可能促进赋予的神经功能的更迅速形成。
由于衰老以及非最适营养,年龄大于50岁的人特别易于患这种疾病。大量膜变形的神经细胞的存在将导致例如认知功能、感觉认知的减退以及不足以控制运动系统(肌肉)的能力。膜变形的神经细胞将开始合成增加量的Aβ(Abeta)蛋白,其诱发淀粉样沉着物,形成斑块和/或神经原纤维缠结。变形的膜还将开始成为几种亲脂化合物(例如几种在这种基质如Aβ特别是Aβ42的二聚体中可溶的肽)的宿主,这可能导致凋亡信号释放并引起神经细胞死亡。
最后,这可能导致脑体积特别是白质的体积萎缩,尤其是在非常老的患者中。由这些效应引起的综合征通常称为痴呆或阿尔茨海默(氏)病,尽管已经描述了这些疾病的具体形式。
神经病变部分地是在其中生物体特别是神经组织较长时间暴露于水平增高的还原性等价物,特别是氢化烟酰胺腺嘌呤二核苷酸(NADH)的情况下引起的。这样的水平在例如胰岛素抵抗如糖尿病的患者、局部贫血(例如手术后或者经受了可将血流量提供给组织的其他生理性创伤)的患者或者酗酒的个体中有所增加。
人们可以区分发生于中枢(脑和脊髓)的神经病变以及周围神经病变。根据本发明的组合物在两种类型的神经病变中均比较有效。中枢胰岛素抵抗可能引起诸如阿尔茨海默(氏)病或帕金森病的神经病变。周围神经病变可传递运动和感觉功能和/或引起疼痛,如下文所阐释的。这种神经病变还可包括特殊器官如肝内的神经功能。不希望受到理论限制,但根据本发明的组合物降低细胞溶质唾液酸酶活性并增加神经细胞必要组分(包括硫苷脂类和神经节苷脂)的生物合成速率,这一点比较重要。
由于抗体袭击引起的神经病变似乎也有所降低。不希望受到理论限制,但在这种类型的患者中,施万型(Schwann-type)细胞功能的改善(特别是根据修复受损鞘磷脂和细胞碎片)对促进该效应比较重要,如同血-神经屏障完整性的改善以及脊髓中神经胶质细胞活化状态的降低一样。这使得本发明的组合物在多发性硬化症的治疗以及慢性或神经性疼痛(与正常疼痛相反)的减退中非常有用。
给予根据本发明的组合物似乎可改善神经细胞之间的相互作用,该效应对于身体对外界(刺激)诱因的多种反应均具有重大的影响。例如,改善了对感觉诱因的恰当注意和处理以及作为对这些诱因的反应而对运动功能的充分限定。相互作用对于公认的情绪过程和认知包括恐惧和疼痛(包括阈功能)的感觉是必要的。
此外,多种器官和/或细胞恰当发挥作用,其至少部分地受迷走神经控制或者对由上皮细胞和巨噬细胞释放的局部乙酰胆碱发生反应,还依赖于神经细胞恰当处理这些信号的能力。这些反应的实例包括对膳食成分形成感觉认知后的胃肠道活性以及心脏在静息状态(心律失常)和运动过程中的活性。另一个实例是免疫系统的活性,特别是在血液、淋巴中循环的免疫细胞的活性,尤其是肺和胃肠道上皮细胞内的免疫细胞的活性。这些细胞包括产生粘液(杯状细胞)和多糖蛋白质复合物的细胞、抗原提呈细胞、Paneth细胞和Peyer氏斑以及淋巴细胞(如局部存在于固有层中的淋巴细胞)的活性,均受到它们的膜组成和功能的强烈影响。
中枢神经系统(包括自主神经系统和下丘脑)功能的改善包括白质的功能化,并导致更好的思维能力,增强的情感、语言交往技能和记忆功能。
发明者称,除了神经递质释放和受体功能(尤其是G蛋白受体),神经细胞的膜组成也得到了改善,特别是膜总质量和/或非极性成分的量相对于极性脂类组分如硫苷脂、神经酰胺、神经鞘脂类、糖蛋白和糖脂的含量。非极性化合物的实例是胆固醇和二聚肽,特别是较大膜蛋白(如淀粉样前体蛋白)的同源二聚非极性肽的量,更尤其是Aβ-42片段的二聚体形式的量。以这种方式,其目的在于改变膜筏蛋白的大小和组成并保持筏蛋白的活性部分的恰当功能。这样,不仅受体的功能发生改变(这可能是由于用于该受体的配体分子亲和性发生变化和区分能力增强,或者例如通过影响第二信使如IP3通路而改变配体的固有活性);而且糖蛋白和膜结合酶的活性也发生了变化。以这种方式,可实现活细胞的代谢和生理活性的显著变化。这特别适用于神经细胞、免疫细胞、骨髓细胞、干细胞和血细胞如红细胞的功能化。本发明发明人发现,通过给予根据本发明的组合物可改善乙酰胆碱的生物合成和转运。膜结合胆碱乙酰转移酶(ChAT)的功能得到改善,以及其在囊泡膜上转运进入突触间隙也得到了改善。乙酰胆碱释放是脑功能的一个必要部分,其包括认知功能以及副交感神经系统特别是迷走神经的活性。神经系统的该部分调节胃肠道行为以及例如心脏节律。通过给予本发明的组合物,可实现对心律失常、消化道活力和消化道介导的全身免疫反应的改善。
根据本发明的组合物对于受损神经组织的修复也非常有用。神经损害可发生于创伤例如手术或脊髓损伤后,还可发生于慢性暴露于高舒张压后的脑内。
根据本发明的组合物在多发性硬化症的治疗中比较有用。脱髓鞘过程减慢,并形成脑内的脱髓鞘斑。
在患有帕金森病特别是原发性帕金森病(PD)的患者中,根据本发明的组合物可降低黑质细胞的退化速率。特别地,在PD患者以及患特殊形式痴呆如路易体痴呆(Lewy体痴呆)或患多系统萎缩症(MSA)和肌萎缩性(脊髓)侧索硬化(ALS)的患者,淀粉样蛋白斑的量以及脑内α-突触核蛋白(α-synuclein)和路易体(Lewy体)的量将降低。
这种过量蛋白在脑特别是神经元和神经胶质细胞内的沉淀,例如亨廷顿氏(Huntington’s)病过程中出现的聚谷氨酸积聚以及多种形式的痴呆、偏瘫和皮质延髓变性中的tau-蛋白,均可通过根据本发明的组合物的干预而很方便地抵消。细胞内膜例如高尔基体和/或内质网膜的改变以及随之发生的蛋白不同修饰在形成该效应时也发挥了作用。
当用来给予患胰岛素抵抗的患者以及给予婴儿或幼儿时,重要的是包含可增加胰岛素敏感性的组分,例如蛋白质成分,其包含所有必需氨基酸,且具有相对较高的天冬氨酸/谷氨酸比值,特别是高于0.42,优选0.44-0.8,更优选0.45-0.6,或者维生素成分,其至少包含核黄素等价物、维生素B6和/或生物素或者优选的包含所有这三种维生素。这种蛋白质成分的实例包括α乳白蛋白或已经加入天冬氨酸的蛋白混合物。
在将所述组合物给予糖尿病患者的情况下,将该组合物作为二甲双胍的佐剂给予而不是与已知会降低胰岛素敏感性的药物同时给予,是更有益的。对于患胰岛素抵抗的患者,进一步优选包括含抗性淀粉(resistant starch)的纤维或纤维样物质,其占所述组合物中的纤维混合物的20wt%以上。对于糖尿病和肥胖个体,包含纤维样物质例如缓慢消化淀粉、乳糖低聚糖、纤维素或果糖低聚果糖/低聚果糖是有好处的,对于这些患者,建议淀粉含量达约30wt%或更多。
根据本发明的组合物中的活性组分还可在胚胎发育过程中调节眼和脑的成熟。因此,根据本发明的组合物可用来给予孕妇,用于形成婴儿的良好视觉和脑功能,包括认知能力和智力能力。
神经细胞之间的通讯增强在抗癫痫性惊厥方面、降低精神分裂症的频率和强度、在降低患抽动秽语综合征个体的发作率和减少ADHD和自闭症行为以及改善睡眠行为方面显得比较重要。
为了对抗这些疾病中的紧急情形,应将根据本发明的组合物包含于生酮饮食中。特别地,根据本发明的营养产品的热价(热值)必须大于该产品中蛋白、脂质和可消化性碳水化合物的热价的40%,优选该量大于46%,更优选大于50%。在这种生酮产品中,脂质成分必须符合上述标准。ω-6长链多不饱和脂肪酸的量应该相对较低,而饱和脂肪酸的量应该相对较高。
存在于根据本发明的组合物中的活性组分似乎对于消化道的恰当成熟及其屏障、免疫和转运功能的恰当发育是必要的。在已患这种消化道疾病的个体中,该效应变得比较明显,包括对肠道感染的敏感性降低、腹泻和细菌过度生长的速率下降以及对食源性变应原的敏感性降低。
不希望受到理论限制,人们认为根据本发明的产品对于改善上皮细胞的膜功能、受体如CD1d受体的功能以及它们增强树突细胞的恰当作用比较重要。这种恰当作用包括释放趋化因子和细胞因子,其补充适当类型的淋巴细胞、提供恰当的“Th1/Th2”反应并引导这些细胞迁移至淋巴结。这些效应降低了病原体移动和病原体识别的速率。人们认为吸引适当类型的T细胞有助于对抗不需要的细胞如变应原、病原体和突变细胞,并确定恰当的反应,比如对于有机体的变态反应。由于例如内皮细胞的质膜组成发生改变,病原体和/或变应原特别是包含疏水部分的变应原粘附更少和/或差异地粘附,这引起更为恰当的反应。此外,上皮细胞产生的粘蛋白的组成特别是与硫酸化和唾液酸化成分的量将增加。
为了获得消化道疾病最大程度的改善,特别是在营养不良的患者中,根据本发明的组合物应该包含胆固醇源(a source ofcholesterol)。特别地,含量必须在2-100mg/100g,优选6-60mg/100g,最优选9-40mg/100g的范围内。恰当的来源是游离胆固醇或胆固醇酯(特别是含油酸的胆固醇酯)或者它们的混合物,优选游离胆固醇与酯化胆固醇的比值为4-10:1。
还认为,上文提及的与免疫系统相关的效应还与改善对促炎症反应诱因的反应以及降低自身免疫反应强度有关。这似乎适用于慢性炎性疾病特别是关节炎、肝炎、胰腺炎和慢性支气管炎的治疗,以及易患I型糖尿病的小婴儿和表现为患类风湿病如类风湿性关节炎和多发性硬化症的老年人的治疗。
根据本发明的组合物有利于肺发育和正确的肺组织修复例如烧伤、暴露于毒剂、肺气肿和慢性身体暴露如慢性咳嗽之后以及在炎症和相关肺感染的过程中及作为肺阻塞性疾病如COPD和支气管炎的结局。
肺组织包含大量特殊的表面活性分子,可通过本发明的组合物增加其生物合成速率。该组合物用于孕妇以改善胎儿肺发育、对胎龄较小的婴儿特别是对呼吸窘迫综合征敏感的婴儿非常有用。肺发育问题可通过在恰当的时刻比如妊娠6个月后分析羊水的组成,特别是(神经)鞘磷脂相比于其他脂质组分的量而确定。
当提供给患者用于改善肺功能时,脂质成分应该包含相对较大量的软脂酸(C16:0),特别地,多于总脂质成分中脂肪酸的10wt%,尤其是10.5-18wt%。在甘油三酯成分中,软脂酸应该优选具有15%以上的sn2位置。
根据本发明的制品在COPD治疗中的效力可通过测定指示呼吸能力的参数如FEV 1.0和/或测定不同类型毒蕈碱受体的表达以及痰细胞的趋化因子分泌(如在Profita M.,et al.(Allergy,2005,60:1361-1369)中所披露的)而形成。
根据本发明的组合物增强对体内所不需要的细胞例如突变或肿瘤细胞的识别,并改变由通过抗原刺激的巨噬细胞的细胞因子生产模式。因此,它们减少患肿瘤的风险,并降低肿瘤在切除或用其他方式如放疗或化疗破坏后的复发率,以及降低转移灶形成率。
细胞膜的组成和结构似乎可在例如形成对胰岛素敏感性的过程中影响细胞内的还原性等价物的转运。因此,根据本发明的组合物在儿童期以及在成人生活中减小发生肥胖的倾向。
在抗肥胖时,所述组合物似乎降低循环性C反应蛋白(CRP)的量并降低通过脂肪组织释放的CRP。增加了通过脂肪组织的抵抗素的内源性合成。以这种方式,可降低代谢综合征患者发生心血管病的几率,尤其是肥胖个体发生动脉硬化和高血压的几率。
特定器官和细胞器的内分泌功能(包括胰腺、下丘脑以及肝内细胞器高尔基体和内质网的功能,并包括神经细胞内小囊泡的生物合成以及内分泌信使从神经细胞中释放)有所改善。据称,根据本发明的组合物有助于胰腺释放胰岛素、囊性纤维变性患者分泌消化酶、垂体对信号(其到达身体其他部位或由身体其他部位产生)的恰当反应以及免疫功能,特别是枯否氏细胞的清除功能以及可生产急性期蛋白的器官的生物合成作用。
为了如上所述的目的,根据本发明的组合物可有益地与几种类型的药物联用。该产品与较大平面分子如他汀类的联合应用上文已经论及,特别是与患有血脂异常的老年人认知障碍的治疗有关的应用。通常,这些患者中相对较大部分具有相对较大量的斑点和缠结。
如果目标在于改善认知功能,特别是当药物使用时间短于约1个月以及当该时期内抑制剂的剂量低于10mg/天,对成人则优选低于2mg/天时,则本发明的组合物可有益地与磷酸二酯酶抑制剂联用。
根据本发明的产品还可有利地与淀粉样蛋白形成的疫苗疗法联用或作为其佐剂。脑内淀粉样蛋白量的快速下降通过防止残余的过量淀粉样蛋白的有害作用的较好的膜的生物合成而被支持。
通常在所述组合物的效果表现出来之前至少需要几天时间,最佳结果可通过在人类应用能达到每日使用该产品且超过1周尤其是超过2周的给药方案而获得。所述给药方案可包括加载期,其中在第一周期间给予2或3个每日剂量,其后则必须应用文献中披露的日剂量,以获得最佳结果。
实施例
实施例1
引言
在阿耳茨海默(氏)病患者中,其中一个标志是存在β淀粉样蛋白(Aβ)斑。Aβ斑的形成引起乙酰胆碱(一种与学习和记忆过程相关的神经递质)产生能力的下降。乙酰胆碱水平的下降造成记忆丧失[Isacson,2002 #766]。用含Aβ的溶液注射大鼠引起类似的学习和记忆问题[Nakamura,2001 #621]。该模型为人们普遍接受的用来检测有益化合物对Aβ所诱导的记忆丧失的作用。该实验论证Aβ输注对乙酰胆碱产生细胞和乙酰胆碱的运载体的作用。此外,采用一种饮食组合物预防这些作用。
实验设计
四组大鼠接受β淀粉样蛋白或盐水溶液输注入心室外侧。输注前5周,用两种饮食之一A或B饲喂大鼠。表1中总结了所述4个组。表2列出了两种饮食的饮食组成。饮食A作为对照饮食,饮食B富含DHA、EPA和磷脂,以改善膜的质量。此外,其富含UMP和胆碱,以刺激膜合成。且富含B-维生素和叶酸以降低同型半胱氨酸(homocysteine)水平。
表1:输注溶液和饮食不同的大鼠分组
表2:饮食组成
结果
表3(和图1)列出了Aβ输注和饮食干预对乙酰胆碱产生和转运能力的作用(影响)。饮食A饲喂大鼠输注Aβ导致乙酰胆碱产生细胞(ChAT)减少,并导致乙酰胆碱转运能力(VAChT)下降。饲喂饮食B则完全将乙酰胆碱的生成和转运能力恢复为正常水平。
表3:ChAT和VAChT的结果
讨论和结论
心室外侧输注Aβ可引起乙酰胆碱生成和乙酰胆碱转运能力下降。这些作用通过饲喂富含ω-3脂肪酸、磷脂、B-维生素和UMP/胆碱的饮食而完全消失。
实施例2
即用型(ready to use)液体产品,用于改善年龄50岁以上的个体的认知功能,每100ml提供:
能量50-120kcal;蛋白质1-10g;脂质1-5g;可消化碳水化合物4-20g,且包含
a-DHA+DPA+EPA=1000-2000mg
b-30-280mg半胱氨酸或牛磺酸
c-100-1000mg磷脂
d-0.5-3mg维生素B6
e-50-500ug叶酸
f-1-30ug维生素B12
g-0.07-2mg锰
h-0.07-2mg钼
实施例3
用于阿尔茨海默(氏)病患者的即饮型(ready to drink)液体,每100ml包含
能量 100kcal
蛋白质 3.06g(酪蛋白,乳清80/20)
碳水化合物 13.3g(麦芽糖糊精,蔗糖)
脂肪 3.73g(鱼油,磷脂)
包括0.96g DHA和0.24g EPA
一磷酸尿苷 0.5g(二钠盐)
胆碱 0.32g
维生素 E 32mgα生育酚
维生素 C 64mg
硒 48μg
维生素 B6 0.8mg
叶酸 0.32mg
维生素 B12 2.4μg
镁 20mg
锌 1.2mg
锰 0.3mg
钼 10μg
还包括0.12g Na、0.15g K、0.12g Cl、80mg Ca、70mg P、1.6mg Fe、13.3μg I、0.18mg Cu、6.7μg Cr、0.1mg F、0.16mg维生素A、0.15mg B1、0.16mg B2、1.8mg B3、0.53mg B5、0.7μg D、4.0μg生物素和5.3μg维生素K。
实施例4
粉末状抗变应性婴儿制品,按15.4g粉末/100ml水新鲜重制(reconstitution)后,可提供:
能量64-80kcal
蛋白质成分1.0-2.0g仅基于游离氨基酸或其盐,且其包括至少2wt%半胱氨酸和0.2wt%牛磺酸
脂质 2-4g 其提供2wt%基于脂肪酸总和的DHA成分包括5-40wt%酪乳脂肪(buttermilk fat)和0.5-8wt%蛋类脂质(包括卵磷脂)
核苷酸等价物 1-40mg UMP与酵母提取物的混合物
锰 65-1000μg 以盐的形式特别是MgSO4包含在内
钼 2.3-300ug 以盐的形式特别是钼酸盐包含在内
胆碱等价物 20-200mg 以盐的形式特别是酒石酸氢胆碱包含在内
在该实施例中,确定所包括其他组分如Na、K、Cl、Ca、P、Fe、Cu、Zn、Se、Cr、I、vit A、D、E、K、B1、B2、B3、B5、B6、B12、B11、生物素和C的量遵循用于婴儿制品的推荐。还包括肌醇。
实施例5
用于免疫功能低下患者的产品
即用型液体产品,每100ml包含
能量 630kJ(或110kcal)
蛋白质 4.0g(酪乳乳清/酪蛋白20-80)
碳水化合物 12.4(3g乳糖,麦芽糖糊精,缓慢消化淀粉)
脂质 5.3(1g乳脂,1g水产动物油,0.6g蛋类脂质,2.7g植物油)
锰 1mg
钼 0.1mg
甜菜碱 100mg
纤维 1.0g(抗性淀粉(resistant starch),半乳糖寡糖50/50)
Na 0.1g、K 0.2g、Cl 0.13g、Ca 0.8、P 0.8、Mg 50mg、Fe 2.4mg、Zn 2.4mg、Cu 0.3mg、F 0.15、Se 8.6ug、Cr 10ug、I 20ug、维生素A 0.12mg RE、D 1.1ug、E 1.6mg TE、K 8ug、B1 0.23mg、B2 0.24mg、B3 2.7mg NE、泛酸1.0mg、B6 0.8mg、B11 80ug、B12 0.4ug、生物素10ug、C12mg
实施例6
用于患癌症、HIV、进行骨髓移植、心脏衰竭或COPD患者的产品。
即用型液体组合物,基于全脂巴氏灭菌绵羊或骆驼乳,每100ml包含:
0.4g藻类、0.4g甜菜碱、0.4g核酸糖和0.2g组氨酸,还包括Na 50mg、K 160mg、Cl 100、Ca 150mg、P 120mg、Mg 52mg、Fe 3mg、Zn 2.8mg、Cu 0.4mg、Mn 3mg、F 0.2mg、Mo 200ug、Se 11ug、Cr 13ug、I 25μg、维生素A 188μg RE、D 1.3μg、E 2.3mga-TE,K 10μg、B1 0.3mg、B2 0.3mg、B3 3.4mg NE、泛酸2mg、B6(以吡哆醛)0.6mg、叶酸100μg、B12 0.7μg、生物素7.5μg和二甲基甘氨酸80mg。
实施例7
用于预防肥胖的产品
液体产品,每100ml包含
能量 336kJ
蛋白质 4.0g(3.6g大豆蛋白分离物、0.2g天冬氨酸、0.2g组氨酸)
脂质 4.0g(多萜醇0.2g,磷脂1g,富集的乳球膜脂质成分0.6g,水产动物油1.0g,菜籽油0.5g,向日葵0.7g,玉米油0.5g)
碳水化合物 12g(乳糖2g,麦芽糖糊精6g,缓慢消化的淀粉2g,2g蔗糖)
锰 1mg
钼 0.1mg
甜菜碱 100mg
纤维 1.0g(抗性淀粉,半乳糖寡糖50/50)
Na 0.1g、K 0.2g、Cl 0.13g、Ca 0.8、P 0.8、Mg 50mg、Fe 2.4mg、Zn 2.4mg、Cu 0.3mg、F 0.15、Se 8.6μg、Cr 10μg、I 20μg、维生素A 0.12mg RE、D 1.1μg、E 1.6mg TE、K 8μg、B1 0.23mg、B2 0.24mg、B3 2.7mg NE、泛酸1.0mg、B6 0.8mg、B11 80μg、B12 0.4μg、生物素10μg、C 12mg。
实施例8
用于患神经病变的糖尿病患者的即用型液体产品,每100ml包含
蛋白质 4.75g(豌豆蛋白,酪乳乳清(buttermilk whey))
脂质 3.78g(包含20%较小脂肪球的绵羊乳脂质成分0.4g,蛋类脂质1g,植物油1.98g和0.4g水产动物油(marine oil))
碳水化合物 11.75g
半乳糖 1.5
帕拉金糖(Palatinose) 3.0
缓慢消化淀粉 1.0
果糖 0.2
麦芽糖糊精 3
葡萄糖 2
异麦芽糖低聚糖 1.05
纤维 2.0g
半乳糖寡糖 1.0
抗性淀粉 0.6
纤维素 0.1
聚果低聚果糖/低聚果糖(Fructo oligofructose/oligofructose)0.3g
面包酵母 0.3g
根据实施例2所述的维生素、矿物质。
实施例9
用于孕妇的产品
蛋白质 3.06g(酪蛋白,乳清80/20)
碳水化合物 13.3g(麦芽糖糊精,蔗糖)
脂肪 3.73g(鱼油,来自绵羊乳的富含糖脂成分)含0.96gDHA和0.24g EPA
一磷酸尿苷 0.5g(二钠盐)
二甲基甘氨酸 0.6g
维生素 E 12mgα生育酚
维生素 C 24mg
硒 38μg
维生素 B6 0.8mg
叶酸 0.32mg
维生素 B12 4.4μg
镁 30mg
锌 1.5mg
锰 0.3mg
钼 20μg
还包括0.12g Na、0.15g K、0.12g Cl、80mg Ca、70mg P、1.6mg Fe、13.3μg I、0.18mg Cu、6.7μg Cr、0.1mg F、0.16mg维生素A、0.15mg B1、0.16mg B2、1.8mg B3、0.53mg B5、0.7μg D、4.0μg生物素和5.3μg维生素K
二甲基甘氨酸半乳糖。
Claims (17)
1.一种脂质组分,包含至少一种选自由二十二碳六烯酸(DHA)、二十二碳五烯酸(DPA)和二十碳五烯酸(EPA)组成的组中的组分和至少一种选自糖脂类组中的组分,用于改善免疫功能、调节宿主细胞与抗原、变应原、趋化因子、细胞因子、其他宿主细胞和/或胰岛素之间的相互作用和/或用于诱导Th1与Th2细胞、CD-1受体或树突细胞的恰当反应。
2.根据权利要求1所述的用途,其特征在于所述组合物进一步包含提供半胱氨酸和/或牛磺酸的蛋白质成分和包括锰和钼中至少一种的矿物质成分。
3.根据权利要求1或2所述的用途,进一步包含核苷酸成分,所述核苷酸成分包括至少一种选自由碱基如尿苷、胞苷、腺嘌呤、胍、胸苷、它们的磷酸化形式特别是单磷酸化形式例如一磷酸尿苷;核苷酸;以及核苷特别是腺苷和鸟苷组成的组中的化合物。
4.根据权利要求1、2或3所述的用途,其中所述脂质成分还包括ω-6长链聚不饱和脂肪酸(具有的碳链长度为18或更长),其含量占所述脂肪酸的8-30wt%。
5.根据权利要求1、2、3或4所述的用途,其中所述脂质成分包括大于0.01wt%的至少一种糖脂类组中的组分。
6.根据权利要求1-5中任一项所述的用途,其中所述糖脂选自由神经鞘脂类如神经鞘氨醇例如鞘磷脂;酸性神经鞘氨糖脂类如硫苷脂和神经节苷脂;以及红细胞糖苷脂组成的组。
7.根据权利要求1-6中任一项所述的用途,其中所述组合物进一步包括可消化的碳水化合物成分,优选半乳糖和/或核糖来源的。
8.根据权利要求1-7中任一项所述的用途,其中所述组合物包括的脂质成分至少部分地来自乳制品、来自蛋类或来自植物种子或豆类的胚乳。
9.根据前述权利要求中任一项所述的用途,其中所述脂质成分包含大小为0.001-10μm的脂肪球。
10.根据前述权利要求中任一项所述的用途,其中所述脂质包括1.3-16wt%的磷脂和/或0.1-20wt%的糖蛋白和糖脂。
11.根据前述权利要求中任一项所述的用途,其特征在于所述组合物包括的蛋白质成分中天冬氨酸与谷氨酸的重量比至少为0.42。
12.用于改善老年对象的认知功能的组合物,具有50-120kcal的能量含量,1-10g的蛋白含量,1-5g的脂质含量,以及4-20g的可消化的碳水化合物含量,其包含
a)1000-2000mg DHA+DPA+EPA
b)30-280mg半胱氨酸或牛磺酸
c)100-1000mg磷脂
d)0.5-3mg维生素B6
e)50-500μg叶酸
f)1-30μg维生素B12
g)0.07-2mg锰;以及
h)0.07-2mg钼。
13.粉末状抗变应性婴儿配制剂,按15.4g粉末每100ml水新鲜重制后,包含64-80kcal的能量含量,以及:
1.0-2.0g的蛋白质成分,其仅基于游离氨基酸或它们的盐,且包含至少2wt%的半胱氨酸和0.2wt%的牛磺酸;
2-4g的脂质成分,其基于脂肪酸的总量包含2wt%的DHA,其中所述脂质成分包括5-40wt%的酪乳脂肪和0.5-8wt%的包括卵磷脂的蛋类脂质;
1-40mg的核苷酸成分,其包括UMP与酵母提取物的混合物。
76.3-1300μg的矿物质成分,其包括65-1000μg的锰,所述锰以盐特别是MgSO4的形式包含在内和2.3-300μg的钼,所述钼以盐特别是钼酸盐的形式包含在内;以及
20-200mg的胆碱,所述胆碱以胆碱盐特别是酒石酸氢胆碱的形式包含在内。
14.根据权利要求1-11中任一项所述的组合物在改善哺乳动物细胞的功能中的应用,所述哺乳动物细胞选自由神经细胞、免疫细胞、干细胞、骨髓细胞和红细胞组成的组。
15.根据权利要求1-11中任一项所述的组合物在刺激哺乳动物的免疫功能中的应用。
16.根据权利要求1-11中任一项所述的组合物在预防哺乳动物肥胖中的应用。
17.根据权利要求1-11中任一项所述的组合物在制造用于治疗以下一种适应症的药物中的应用,所述适应症选自由神经病变、免疫功能低下、肥胖、糖尿病、自身免疫疾病、心律失常、心脏衰竭以及由糖尿病引起的慢性炎症和感染组成的组。
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CN2006800533029A Active CN101384184B (zh) | 2005-12-23 | 2006-12-22 | 用于预防肥胖症的婴儿营养组合物 |
CNA2006800527013A Pending CN101370396A (zh) | 2005-12-23 | 2006-12-22 | 用于改善膜组成的包括多不饱和脂肪酸的组合物 |
CN2006800513063A Expired - Fee Related CN101389227B (zh) | 2005-12-23 | 2006-12-22 | 预防肥胖的婴幼儿营养组合物 |
CN201710513954.6A Pending CN107495379A (zh) | 2005-12-23 | 2006-12-22 | 含有多不饱和脂肪酸、蛋白质及锰和/或钼的组合物 |
CN200680051657.4A Active CN101360489B (zh) | 2005-12-23 | 2006-12-22 | 用于改善膜组成的包含多不饱和脂肪酸、蛋白质和锰和/或钼的组合物 |
CNA2006800524072A Pending CN101370491A (zh) | 2005-12-23 | 2006-12-22 | 用于改善膜组成的含有多不饱和脂肪酸、蛋白质及锰和/或钼的组合物 |
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CN102892300A (zh) * | 2010-03-17 | 2013-01-23 | N·V·努特里奇亚 | 用于改善脑膜的脂肪酸组成的婴儿营养品 |
CN110840873A (zh) * | 2019-11-28 | 2020-02-28 | 广东海洋大学 | 二十二碳五烯酸在制备预防和治疗精神分裂症药物中的应用 |
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