CN1304009C - 包含核糖和叶酸的营养制剂及其药用 - Google Patents
包含核糖和叶酸的营养制剂及其药用 Download PDFInfo
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Abstract
外伤、外科手术、炎症、低生育力、泌乳问题、肠道失调、婴儿营养、癌症、关节炎和其它关节疾病、血管疾病和心血管或脑血管疾病、局部缺血、老化、免疫功能下降、烧伤、脓血症、营养失调、肝脏或肾脏疾病、疟疾、囊性纤维化、偏头痛、神经性疾病、呼吸道感染、改善运动结果、肌痛、药物依赖性和疼痛可以用一种营养组合物治疗,所述营养组合物含有有效量的核糖和叶酸,任选地组合有其它组分如烟酸、组氨酸、谷氨酰胺、乳清酸、维生素B6和其它组分。
Description
本发明涉及营养,药物或饮食制剂,其包含核糖或叶酸或其功能类似物,及涉及这些组合物在预防或治疗与总核苷酸代谢失调或不足相关的特异疾病中的用途。
发明背景
核苷酸是在所有哺乳动物中均存在的杂环化合物。核苷酸由一个嘌呤或嘧啶碱基,一个糖单位和1-3个磷酸基团组成。在人体内存在的主要嘌呤碱基是腺嘌呤(6-氨基嘌呤),鸟嘌呤(2-氨基-6-羟基嘌呤),次黄嘌呤(6-羟基嘌呤)和黄嘌呤(2,6-二羟基嘌呤);主要的嘧啶是尿嘧啶(2,4-二羟基尿嘧啶),胞嘧啶(2,4-二羟基-5-甲基嘧啶)和胸腺嘧啶(4-氨基-2-羟基嘧啶)。所述糖组分可以是核糖(在核糖核苷中)或2-脱氧核糖。所述糖组分在所述碱基的N9位通过β-N-糖苷键与所述碱基相连;所述磷酸基团通过3’或5’位与所述糖组分相连。当所述磷酸基团从核苷酸中分裂出时,称为核苷的化合物形成。
本申请文件中,总核苷酸代谢(TNM)是指在哺乳动物机体中发生的有核苷酸,其前体和代谢物作为主要成分直接参与其中的所有生物化学途径的组合。所述途径包括嘌呤和嘧啶的合成途径,分别起自氨甲酰磷酸和5-磷酸核糖焦磷酸(PRPP)的从新和补救途径。它们还包括各种核苷酸的互换,各个核苷和核苷酸的磷酸化和去磷酸化反应,及核苷酸分解代谢为从体内清除的化合物的途径。它们不包括因此从磷酸化的核苷酸中分裂出的含磷基团的进一步反应。
核苷酸及其相关的代谢物在生命活动中发挥重要作用,这见于生物化学方面的文献所述。三磷酸形式,尤其三磷酸腺苷(ATP),是哺乳动物机体化学能量的主要形式。这种类型的能量例如是使希望的生物化学反应以较高比率发生,维持膜内外离子梯度,及使一些重要的成分跨膜转运。核苷酸还可以在大量生物化学反应中提供磷酸根。核苷酸(碱基)可以形成DNA和RNA的构件。核苷酸及其衍生物可作为许多代谢过程的介质或调节因子;例如环状单磷酸腺苷和鸟苷在细胞膜中的受体激活后起第二信使的作用。由于变构作用,它们调节许多途径。ADP参与血小板聚集。腺苷是一种强血管扩张因子,而且针对其它核酸碱基的受体也已经阐述。核苷酸还是许多关键辅因子如NAD,FAD和CoA的一部分。
核苷酸在许多反应中还激活中间体。单糖的互换反应需要通过各种核苷酸激活;这些单糖形成糖蛋白的重要组分。乙醇胺在其能被修饰为胆碱之前也需要激活,需要ATP激活甲硫氨酸以使其起甲基供体作用。
核苷酸或其前体可以在机体内形成或从饮食中获得。来自饮食的核苷酸在消化道中可被分解为核苷和核酸碱基,其能迅速被肠道吸收,并可以再装配为核苷酸和相关的代谢物。黄嘌呤在饮料和巧克力中普遍存在。
核苷酸可以在一些组织中从头合成,其通过使用需要存在许多能量(ATP)和许多反应物的途径进行。这是人体存在能有效再利用核苷酸分解代谢产物的补救系统的原因。
在一些条件下,例如当进食不均衡饮食或当在短期发生(严重)组织损害时,机体暂时暴露于大量的核酸中。在这种情况中,嘧啶分解代谢为β-氨基异丁酸(胸腺嘧啶)或β-丙氨酸(例如尿嘧啶),其可以通过尿液清除。β-丙氨酸也可通过与组氨酸或1-甲基组氨酸反应而用于肌肽和鹅肌肽的生物合成。过量的嘌呤代谢为黄嘌呤(2,6-二羟基嘌呤)和最终的尿酸(2,6,8-三羟基嘌呤)。
尿酸主要在肝脏中合成,并随后释入循环中。在胞外液体中(例如滑液或血浆中),其以离子形式存在。在血清中的正常水平是3至6-7mg/100ml。后一浓度类似于或高于尿酸单钠在37℃的溶度积,这表明(局部)尿酸盐结晶沉淀的危险。尿酸盐通常主要(>2/3)通过尿液清除。
高尿酸血症是指当血清尿酸盐男性高于7.0mg/100ml,女性高于6.0mg/100ml以上时的情况。高尿酸血症的发生与肥胖,高血压,酗酒,和充血性心脏病等疾病相关,但不认为其是导致这些疾病的原因。然而高尿酸血症可以导致如痛风性关节炎,泌尿系结石及甚至肾病等疾病,而且还可以发生在Lesch-Nyhan综合征中。因此保证在所有时间血清和尿液中尿酸盐水平保持在正常数值是重要的。
在正常情况下,尿酸对于血浆的总抗氧化(自由基清除)能力有显著贡献。已经报道总抗氧化能力对解毒活性反应组分如游离自由基和毒性(外源性)化合物是重要的,所述游离自由基例如是那些在失控炎症期间释放的自由基。还报道了净化游离自由基对预防细胞膜损害是重要的。
通常用作抗氧化剂的化合物如抗坏血酸和维生素E需以极大数量施用,以使其达到与血浆总抗氧化能力相同的程度。由于这些成分的氧化强化剂作用,将在产物中产生非所需的副作用,而且持续时间较长,在食用这些产物的人体中也有副作用。施用符合尿酸盐抗氧化能力的其它具有氧化还原活性的化合物,可以产生非所需副作用,如与其它循环中的抗氧化剂/自由基清除剂如血清白蛋白相互作用。
尿酸盐通常是通过黄嘌呤脱氢酶从黄嘌呤中产生的。在一些条件下,这些酶转换为黄嘌呤氧化酶。在这种形式中,所述酶使用氧作为氧化剂,并形成过氧化氢。在过氧化氢造成伤害之前中和之,这一点很重要。
因此需要研制一种制剂,其保证胞外液体如血浆的恒定和足够高的抗氧化能力,而在产物和患者体内均无非所需的副作用。
由于其对生命活动的重要性,核苷酸被迅速代谢并呈现高代谢率。一些代谢物可以使用熟知的途径互变。这些途径是高度可调节的和相互依赖的。在正常情况下,这些途径迅速发生。这保证所有核苷酸和/或相关的代谢物的浓度相当恒定,浓度值依赖于各种组织和细胞条件的需求,及依赖于参与TNM的许多组分的局部浓度。
在一些条件下,人体不能保持所有核苷酸和相关代谢物在所有组织和细胞中的动态平衡。
一些疾病与核苷酸代谢尤其与特异组织的ATP水平相关。在局部缺血的情况中,ATP的组织浓度迅速降低,在蛋白质—能量营养失调中同样发生这种现象。
因此需要一种营养制剂,其保证在不同的组织中存在适量的核苷酸,而且以这种方式在各种代谢物的数量之间不会出现不均衡。
在婴幼儿配方领域中已经意识到存在适当浓度的核苷酸的重要性,尤其在保证婴幼儿的发育或保持正常肠道功能中很重要。加入特异数量的各种核苷酸或其代谢等价物以获得这种结果。见例如WO95/18618和WO 95/18547所述。人乳汁成分用作参考。
然而,本领域未阐述各种组织在不同条件下需要的核苷酸数量。这适用于早产儿童的肠道发育,也适用于由于外伤,放疗或外科手术而损害的组织或包括细胞迅速分裂的组织的暂时局部需求。目前还未知的是每天口服多少毫克的剂量真正适用于各个患者。因此施用核苷酸混合物可易于导致无效剂量或特异核苷酸或其代谢物过量。核苷酸或相关代谢物的数量和类型的不均衡,也可易于打乱细胞中的正常代谢过程,特别是在敏感细胞如红细胞中。
在生产实践中,核苷酸是昂贵的配料,难以生产出消费者可接受价格的有效制剂。
由于这些原因,目前寻求可用于营养制剂中及可影响核苷酸水平的其它成分。
谷氨酰胺,是胺基团的重要供体,在核苷酸的生物合成中起重要作用。Kovacevic在1987年证明谷氨酰胺与肌苷一起施用提高细胞ATP含量。单独施用谷氨酰胺无效。
EP-A 0 540 462揭示了使用L-谷氨酰胺或其功能等价物治疗参与耐力训练,体力活动或训练过度的人血液中L-谷氨酰胺水平降低。
D-核糖是一种在许多有机体中出现的戊糖。当葡萄糖在人体内通过氧化戊糖途径代谢时,它是葡萄糖代谢产物之一。这个途径产生磷酸戊糖,其能互变及产生三磷酸甘油醛,用作能量来源。
核糖还可以是通过ATP激活为5-磷酸核糖-1-焦磷酸(PRPP),其在非常需要能量(ATP)的合成途径中及在这些碱基的补救途径中参与嘌呤和嘧啶的从头生物合成。
包含作为单一活性成分的核糖的营养制剂是可商购的,其用于提高运动员的体力。
WO 99/65476阐述了使用0.1-100g/天戊糖,优选核糖,及优选1-20g/天,任选地组合肌酸,镁,肉毒碱和精氨酸,以提高机体体内能量水平。在DE 19659755中,Pliml揭示了可使用1-50g/天的核糖以提高运动员的体力。Palazzi在WO 92/15311中揭示了组合使用0.2-2g/天核糖和0.1-1g/天天冬氨酸镁。
Carniglia在美国专利No.5,391,550中揭示了口服包含核糖,氨基酸和选自胆碱,肌醇和肉毒碱的一种化合物的一种产品,有效提高胞内ATP水平及改善创伤修复。优选地,所述组合物包含10-40%的核糖,30-60g氨基酸和10-30%的胆碱,肉毒碱或肌醇或其组合。我们认为不需要后一成分支持TNM,因此在本发明的产物中不包含其。
美国专利No.4,719,201和美国专利No.4,605,644揭示了任选地与腺嘌呤组合的核糖,当所述化合物存在于例如手术期间灌注组织的溶液中时,可以改善在局部缺血后的恢复。在美国专利No.4,880,783中,揭示了一种心脏灌注液,其包含腺苷,核糖和次黄嘌呤,增加在手术期间心脏缺乏正常氧供的时间。
这些文献中无一揭示了核糖在提高胞内ATP和改善创伤修复中的益处。也未揭示避免核糖数量太多以至于不能转变为核苷酸和尿酸的措施。也没有报道当叶酸或其它适当的活性成分与核糖一起施用时的协同作用,尤其在进食与其状况不适应的饮食的人群中。
现有技术揭示了在一些情况下,必需食用大量核糖(接近100g)才能观测到有益效果。这对食欲不好或限制其每天食用的饮食体积的人如老人造成明显难题。
因此需要一种营养制剂,其更有效支持机体内总核苷酸代谢,而不产生现有技术中存在的缺点。支持总核苷酸代谢应在所有组织中引起所有核苷酸和相关代谢物水平提高,尤其在需要的情况下,但只增加至最佳值。这应导致下文定义的用途。使用现有技术领域产物相关的缺点是价格高,而且施用较高数量的特异核苷酸有明显干扰代谢的危险,尤其在敏感细胞中,及有高尿酸血症和相关疾病的危险。
发明概述
已经发现包含核糖或其功能等价物和叶酸或其功能等价物的一种营养制剂在需要其的人体中支持总核苷酸代谢。这种支持是通过最佳使用哺乳动物体内存在的代谢和调节系统而达到的。与使用现有技术领域所述方法相比,核苷酸或相关代谢物局部供应不足得以较早恢复,高尿酸血症的危险性降低。核糖应以每日剂量至少0.5g直至大约40g的量使用。叶酸应以至少100μg/天直至大约20mg/天的量使用。
所述成分是食品级,无毒,源于天然,可以以规定的质量和合理的价格获得,且便于包含在广泛的饮食或营养制剂中。另外,它们具有良好味道。
为提高所述制剂的效果或降低TNM中不均衡的危险,根据本发明,优选还包含其它成分。所述成分可以是镁,乳清酸,烟酸,硒,维生素B1,维生素B6,葡萄糖,柠檬酸盐,特殊氨基酸如组氨酸或谷氨酰胺,磷酸盐,硫酸盐或维生素B12,其等价物和/或其组合。
本发明的组合物可以用于调节和支持TNM总核苷酸代谢。已经发现这种作用有利于预防和治疗多种疾病,功能失调和健康问题。这些包括外伤,外科手术,炎症(急性或慢性),低生育力,泌乳问题,肠道失调,婴儿营养性疾病(黄疸,肠道化脓),癌症,关节炎(骨关节炎,类风湿性关节炎)和其它关节疾病,血管疾病和心血管或脑血管疾病,局部缺血(周围血液供应减少,梗塞),老化,呼吸道感染,免疫功能下降(如化疗后及AIDS期间),烧伤,脓血症,营养失调,肝脏或肾脏疾病,疟疾,囊性纤维化,偏头痛,神经性疾病如Huntington,Parkinson,Alzheimer,精神分裂和抑郁,改善运动结果,肌痛,药物依赖性和疼痛。
所述产物优选用特异于使用所述产物的患者群的成分加强,详见于以下所述。
发明详述
本发明的营养、药物或饮食制剂可以以干燥形式生产,例如条状,粉末,片剂,小饼或麦片。所述制剂也可以是液体形式,例如饮料、现冲的饮料,布丁,沙司或浓汤。
所述制剂是使用本领域已知方法生产的。例如,可以通过喷雾干燥或在转鼓式干燥机上生产粉末。可以将喷雾干燥的粉末聚集以改变容积密度或溶解性(例如可湿性)。当生产粉末时,可采取本领域已知的方法防止粉末粘集,例如加入特殊制剂如磷酸三钙或二氧化硅。当生产片剂时,包括常用的压片剂(如硬脂酸镁)。为使所述营养制剂具有最佳感官性质,可以使用本领域已知方法,如设置pH及加入调味料和色素。也可以加入防腐剂以提高保质期,本领域已知其使用方法。
混合适量的配料以生产最终产物。最终产物还可以包含隔离的区室,每个区室均可以包含所需配料的总数或总量的一部分。
最终产物可以以与选择的产物类型适应的方式包装。本领域已知这些方式。例如,液体可以包装在瓶中或纸盒中,所述瓶或纸盒的体积适于含有0.5-10日剂量所需的体积。粉末可例如包装在罐,口袋或小袋中。这些包装具有典型地0.5-50日剂量的体积。
所述活性成分可以与其它适当配料混合。例如,粉末形式的本发明制剂可以使用来源于奶,蔬菜或动物的喷雾干燥的蛋白质,如脱脂奶粉,乳清粉,蛋白粉,马铃薯蛋白,大豆蛋白等,或其水解物或混合物。优选使用组氨酸和谷氨酰胺相对富集而色氨酸较少的蛋白质,如酪蛋白。可以加入特异的合成氨基酸如L-组氨酸,或肽如丙氨酰谷氨酰胺或谷氨酰谷氨酰胺以达到这种目的。
当所述营养制剂中包含蛋白质时,所包含的数量依赖于产物的应用。在完全配方中,典型地每日剂量为5-120g。在婴幼儿的完全配方中,数量为每天剂量为5-15g,优选6-10g/天。在外科手术患者的完全肠道营养配方中,典型地每日剂量为50-120g,优选60-90/天。
在补剂中,典型地每日剂量包含0-60g蛋白质。在针对运动员和暂时需要高蛋白的人(如烧伤患者)或氨基酸缺乏的人(例如由营养失调所致)的补剂中,每天剂量可以多至60g。在其它情况中,产品中不包括蛋白质或其以较低量存在,典型地每天剂量为0-20g。在补剂中,包含游离氨基酸尤其是组氨酸,特别是L-异构体是有利的。在一些情况中,TNM支持物应与生长和合成代谢支持物组合。
组氨酸,支链氨基酸亮氨酸和异亮氨酸,赖氨酸,甲硫氨酸和苯丙氨酸的混合物似乎具有合成代谢性质。例如,在运动员的饮食中每天以2g以上优选4g以上的剂量补充以下氨基酸混合物对肌肉生长尤为有益:3-10wt%组氨酸,5-15wt%异亮氨酸,10-23wt%亮氨酸,10-23wt%赖氨酸,5-15wt%甲硫氨酸,5-15wt%苯丙氨酸和5-15wt%苏氨酸。所述产品在这种情况下应不含有或含有很少的蛋白质。
当所述产品中包含相对大量的蛋白质或氨基酸时,优选增加所述产品中维生素B6的数量。应包括在所述产品中的超额量可以通过使用以下标准测定:每100g蛋白质等价物中2mg超额的维生素B6。作为维生素B6的来源,可以使用吡哆醇,吡哆胺或吡哆醛或其功能等价物。
也可以使用能作为葡萄糖供给者的粉末状碳水化合物。葡萄糖糖浆(干糖浆)或淀粉及尤其其水解物是有益的。在甜品中,优选使用重度水解的麦芽糖糊精。在较咸的产品中,应使用轻度水解的麦芽糖糊精,优选使用那些水解度低于12的麦芽糖糊精。
在所述产物中包含葡萄糖是重要的,因为其可以使足量的还原等价物和化学能量生物合成。这两种物质均是总核苷酸代谢必需的。另外,葡萄糖可以中和过量的核糖,这个反应是由磷酸硫胺素和镁支持的。在以下情况中从葡萄糖中也可以形成额外的核糖:(1)通过所述产品给予的核糖太少;或(2)相对于组织所处的特定条件导致的需求,在组织中存在太少的核糖。因此优选在所述产品中包含1-50g葡萄糖或其功能等价物,更优选2-20g。
同样,每日剂量还应包括0.4-10mg,优选1.0-8mg硫胺素或其功能等价物。优选地,使用盐酸盐。
作为活性成分的来源,可以使用纯化的化学物质或其功能等价物如外消旋混合物或食品级的原料提取物或其混合物作为配料。
D(-)核糖是一种戊糖,其可以作为晶体产品购买。核糖还是核酸的主要组分。这些核酸可以分离自酵母或肝脏中。核酸级分或其水解产物的提取物可以用作核糖来源。优选使用一种制剂,由于可能发生内源核苷酸浓度的不均衡,其包含高于核苷酸,核苷和核酸碱基总和数量的核糖。也可以使用碳水化合物水解产物的粗提物。例如马铃薯淀粉可以通过酶处理而转变为富集核糖的成分。本说明书中所指最优选的核糖不包括核酸结合的核糖。
优选使用合成的外消旋核糖,但最优选是D(-)核糖。当D(-)核糖用作核糖来源时,应包含每天大约0.5-40g,尤其1-15g,最优选2-10g的剂量。当其它物质用作核糖来源时,依赖于配料中核糖的含量而确定所述组合物中应包含多少粗配料。
在本说明书中提及的叶酸包括其所有功能等价物。叶酸是一种维生素,可以以游离叶酸(蝶酰谷氨酸)或亚叶酸(甲酰四氢叶酸)形式购买。多谷氨酸形式也可以用作功能配料,尤其当配方中还存在锌时。在按叶酸含量标准化的条件下,叶酸的丰富来源是酵母和肝脏及一些绿色植物(椰菜,芽甘蓝,菠菜)或果实(柑橘类水果)的提取物。优选使用合成的叶酸。为有效发挥作用,所述组合物应包含至少100微克叶酸/天。选择这种限制以支持婴幼儿中合适的总核苷酸代谢。在成年人中,所需的数量较高;优选每日剂量为250微克以上,最优选400微克以上。在那些代谢叶酸的酶系统遗传性病变的成人中需要更高数量的叶酸,例如1g/天以上。针对正常成人,最优选在产品中最多包含5mg叶酸。当每天每公斤体重补给4微克以上叶酸时,优选每100mg叶酸包括至少1微克维生素B12。
为观测到最佳效果,需要在产品中包含烟酸。烟酸当与核糖和叶酸一起供应时,在支持TNM及DNA和RNA形成方面具有协同作用。在供成人的产品中每天应包含至少4mg烟酸等价物(=NE),尤其30-200mg。认为在这种剂量下,烟酸在许多人中为疾病组织提供额外的还原等价物,以提高化学能量的产生及不同形式的核苷酸和叶酸的转化,和提高DNA形成及提高三磷酸形式的所有核苷酸的组织水平。
在所述配方中还优选包含镁。镁不足的发生更为常见。镁不足将导致将激活的磷酸根转移至其它分子上的能力降低。每日剂量中应存在至少20mg的镁。供给成人的产品中优选每天包含100-500mg镁(依赖于所述产品的应用)。
包括一些能影响所需代谢模式的速率的化合物是重要的。为此,所述产品应优选包含组氨酸。加入组氨酸还中和过量的β-丙氨酸及使足够的肌肽和鹅肌肽生物合成。典型地,组氨酸的数量为大约0.2-5.0g/日剂量,优选0.3-3g/日剂量。当存在组氨酸时,优选还存在葡萄糖,组氨酸与葡萄糖的重量比为0.015-1.5,所述产品应该不用合成的色氨酸或肽加强。
内源性无机磷酸盐是一种重要的途径调节剂。另外,避免其不足是重要的。当本发明产品中包含磷酸盐时,每日剂量的量在20-2000mg范围内,优选在100-1000mg范围内。
柠檬酸盐可以以纯化的晶体柠檬酸或其盐形式使用,但其也存在于水果(柑橘,酸橙)提取物中。当包含柠檬酸盐时,最终产品的pH值应在3-8,优选6-7.5范围内。每日剂量的本发明产品的柠檬酸盐的量根据所述产品的用途应是0.1-6g,优选0.3-3g。
乳清酸是指在食用后在血浆中提供乳清酸离子的那些成分。适当的来源是乳清酸(6-羧基-2,4-二羟基嘧啶),其盐如钠盐或钾盐或锌盐,酯如胆碱酯或甲酯,及富含乳清酸的提取物如一些来自肝脏的提取物。也可以使用前体如精氨酸,谷氨酰胺或天冬氨酸。
为有效发挥作用,本发明产品每日剂量应包含0.1-8g乳清酸。这个数量通常少于所述产品中核糖或谷氨酰胺的数量,而且应通过使用每公斤体重给予大约0.04-0.3g乳清酸的标准加以确定。当精氨酸或天冬氨酸用作乳清酸的前体时,每天应给予1g以上,优选5g以上。据信乳清酸保证嘧啶的正常生物合成及中和在患者特殊状况下形成的过量的核糖。这也保证β-丙氨酸,肌肽和鹅肌肽的足够组织水平。
发现在本发明产品中包含维生素B12会提高组织中核苷酸水平。作为维生素B12的来源,可以使用钴胺素如氰钴胺素。所用数量应是0.2-4000微克/日剂量,优选0.5-5微克/日剂量。
如上所述,当本发明产品用于预防或治疗一些脑部功能失调或神经退化疾病如时,重要的是包含维生素B6,所述疾病如Parkinson,Huntington,Alzheimer,ADHD,抑郁,精神分裂和情绪失调。这个数量应是2-10mg/日剂量,优选2-4mg/日剂量。针对其它应用,如婴幼儿配方,本发明产品可以包含较少量的维生素B6。通常地,本发明的制剂包含0.3-10mg/日剂量,优选0.5-4mg/日剂量。
本发明产品中优选包含硒,以保证为过氧化氢酶适当补给这种关键成分。作为硒源,可以使用硒盐如亚硒酸钠,但也可以使用富含硒的原料如硒酵母的提取物。本发明产品每日剂量中包含的数量是10-300微克,成人特别是40-150微克。
根据所述营养组合物的应用,其它食品级的成分如脂质(一般的),添加的维生素,矿物质,微量元素,肉碱,肌酸,辅酶Q10,共轭亚油酸(CLA),α-硫辛酸或其功能类似物或纤维素,可以是所述组合物的一部分。现有技术揭示了这些成分针对疾病特异性营养组合物的使用。
所述组合物中优选包含长链多不饱和脂肪酸,尤其Ω-3不饱和脂肪酸如DHA,EPA和硬脂酸,以增强患者的免疫功能。这些脂肪酸可以源自已知来源如海藻油,鱼油,选择的植物油(例如来自Echium),或来自合成的来源。
本发明还涉及一种增强血浆中尿酸抗氧化能力的方法,包括施用有效量的选自核糖和叶酸的至少一种化合物。有效量根据治疗对象的状况和所需抗氧化能力而确定,而且可从下表1中所提供的加以选择。也可以存在其它抗氧化剂,优选所用剂量低于常用剂量。
临床应用
可以使用本发明组合物的情况包括那些其中生物合成能力不足的情况,例如由代谢失调或营养不良所致。在这种情况中,局部需要大量的特异性核苷酸和/或相关的代谢物,例如由于疾病或局部失调或特异性损害,而且营养素和TNM成分的转运不健全。
从本发明这些产品中获益的人群是核苷酸合成,补救或转化全面不足的那些人,如那些蛋白质—能量营养不良的人或参与TNM的一种酶的表达遗传性障碍的那些人。由于其酶系统的发育低下,在未成年人和婴幼儿中也可以发生相同的问题。许多老年人和有肝脏病变的人(例如由于酗酒或肝炎),其核苷酸合成能力也不足,这由于酶系统不健全及需要支持TNM中最关键的步骤。
本发明产品还用于那些局部或暂时需要非常高数量核苷酸或相关代谢物,而且这种需求不能易于通过适当的生物化学能力解决的情况中。在外伤的情况中(例如在意外事故或手术后),局部必须产生大量的所有核苷酸以修复(置换)损伤的组织。在各种炎症期间,在一些淋巴细胞迅速增殖期间,大量需要核苷酸以供应组织合成所需。另外,提高相应的胞外液体的总抗氧化能力,尤其在存在失控炎症反应的情况中是有益的。
在精子发生期间,在哺乳期间及在(增加)合成血液成分期间的骨髓中也必须局部利用大量的核苷酸。本发明产品因此也用于改善低生育力,提高哺乳期乳汁质量和数量,在手术后使用也是有益的。这些类型患者的营养品可以用痕量元素,矿物质和维生素加强,以符合其营养需求。在手术后使用的产品应优选包含一种分离自蛋或奶的蛋白质和脂质来源,及生长因子如类胰岛素生长因子和内皮细胞生长因子。
在正常情况下,肠道上皮具有相对短的半衰期而且是从特定的干细胞中产生的。在增殖期间以及在成熟(迁移)期间,这些细胞的核苷酸和/或能量需求较高。一些肠道功能失调与肠道细胞的非常高的生产量相关,其需要局部利用大量各种核苷酸。包含谷氨酰胺或其等价物将进一步增强本发明营养组合物的效力,尤其当以大于1g/日剂量给予时。
在化疗或放疗后的恢复期间,也必须利用正确的相应比例的大量核苷酸。在治疗期间,由于细胞程序死亡,大量细胞死亡,释放大量核苷酸。一旦这些核苷酸代谢,则需要额外的生物合成能力以解决高度需求问题。本发明的营养组合物将支持由于化疗损伤后尤其粘膜组织损伤后的恢复。
核苷酸的生物合成能力暂时不足在局部缺血的情况下特别明显,这可以在外伤,手术和心血管和脑血管疾病中发生。血液供应减少导致基底组织中核苷酸或相关代谢物的数量较少。据认为通过补给本发明产品,所需核苷酸或相关产物的浓度得以足够高以改善缺血组织的状况。在所述组织是脑组织的情况下,本发明产品将降低被释放的兴奋性氨基酸如谷氨酰胺的数量。
在强度训练后,也明显表现出组织核苷酸含量不足和/或TNM能力不足。ATP库将迅速耗竭,而且在训练中损伤的组织修复或置换之前将持续较长时间。这将产生肌痛和损伤。本发明产品还用于治疗MS和疲劳。
核苷酸在细胞代谢中起重要调节作用,而且在肌肉需求量高而血液供应不能满足需求时期,可以在天冬氨酸的分解代谢中作为胺基团供体或受体。
本发明产品还用于预防癌症。不希望受理论束缚,据认为腺嘌呤和PRPP参与ADP-核糖聚合到核蛋白上,这对细胞调节和DNA修复是重要的。改善修复损伤的DNA的可能性可以防止肿瘤细胞的发展。
本发明产品还特别用于预防和治疗类风湿性关节炎及其它关节病变。据认为本发明产品通过其对硫酸化能力的作用而起作用。这将提高组织液和滑液中硫酸化多糖的浓度和/或种类,因此改善润滑性。
本发明产品还改善免疫功能。不希望受理论束缚,我们认为这种效果是所述配方对粘液组成和糖蛋白、免疫球蛋白和蛋白聚糖的内源数量水平的作用效果。这些成分是膜结构的适当功能包括其识别功能和酶功能、尤其是其特异性所必需的。对粘液的屏障功能的这种有益效果对呼吸道感染或普通感冒患者特别有意义。
本发明制剂还用于预防组织的血液供应问题。据认为这归因于血液凝固参数的改善和对微血管化的作用。本发明产品还有助于治疗囊性纤维化及治疗或预防疟疾和结核。本发明产品的作用还通过用维生素B6强化,尤其以3mg/天以上数量强化而加强。
本发明产品还用于治疗中毒,例如由于滥用药物,但也由于胆红素代谢问题。认为本发明产品保证足够的葡糖苷酸化或硫酸化缀合。本发明产品还支持类固醇代谢调节。
本发明产品还用于治疗疼痛,如明显的偏头痛和梗塞后胸痛发作。据认为本发明产品调节腺苷的数量,以这种方式保持血管舒张作用及避免局部浓度突然升高。
本发明产品还有助于治疗肾衰,局部缺血如梗塞和脑血管意外,肠炎和癌症或有此危险的患者。据认为这通过恢复β-丙氨酸,肌肽和鹅肌肽的组织水平而进行。
在本发明产品用于治疗或预防心血管或脑血管疾病的情况中,在本发明产品中包含肌酸,肉碱,辅酶Q10,鞣酸,维生素B12,维生素B6,Zn,和/或Mg是有益的。
本发明产品在治疗与脑中神经递质水平不均衡相关的功能失调中也是有益的。脑中神经递质的不均衡出现在Parkinson′s病,Alzheimer′s病,ADHD,精神分裂症,抑郁症,和情绪失调症中。所述作用据认为是通过提高联合给予的或体内已存在的维生素B6的效力,及调节多巴胺,肾上腺素,5-羟色胺和去甲肾上腺素的代谢而获得的。
表1:本发明营养制剂的活性成分列表
成分/组分 | 每日剂量中的量 | ||
全范围 | 优选范围 | 最优选范围 | |
核糖叶酸烟酸镁葡萄糖蛋白质组氨酸无机磷酸盐维生素B1维生素B12谷氨酰胺乳清酸柠檬酸盐硒维生素B6 | 0.5-40>100 | 1-15250μg-20mg>4>201-500-120g0.2-520-20000.4-100.2-40000.5-300.1-8g0.1-610-3000.3-10 | 2-10g400μg-5mg30-200烟酸等价物100-500mg2-20g0.3-3g100-1000mg1-8mg0.5-5μg1-10g0.3-3g40-150μg0.5-4mg |
实施例
1.改善运动员体力的营养制剂
每日剂量配料:
3g氨基酸混合物,其由10wt%组氨酸,10wt%异亮氨酸,20wt%亮氨酸,15wt%赖氨酸,12wt%甲硫氨酸,10wt%苯丙氨酸和13wt%苏氨酸组成
5g D-核糖
10g麦芽糖糊精DH19
2g MCT油
200μg叶酸
30mg烟酸
0.5g乳清酸
500mg磷酸镁
50mgα-硫辛酸
将产品包装在小袋中,以在水、果汁或奶或类似液体中复水。
2.粉末状营养补剂,每日剂量中含有:
17g氨基酸混合物,其由2g谷氨酰胺,0.7g精氨酸,0.5g组氨酸,0.4g异亮氨酸,1.0g亮氨酸,0.9g赖氨酸,0.3g甲硫氨酸,0.3g苯丙氨酸,0.3g苏氨酸,0.6g缬氨酸组成
6g D(-)核糖
20g麦芽糖糊精
300μg叶酸
40mg烟酸
2mg盐酸硫胺素
2μg氰钴胺素
1.0g乳清酸钠
400mgα-硫辛酸
225μg生物素
15mg泛酸
1mg盐酸吡哆醇
0.5g碳酸钾
0.5g柠檬酸钠
0.5g氯化钠
0.6g氯化镁
0.6g磷酸三钙
50mg抗坏血酸
20mgα-维生素E
微量调味剂
将八天剂量包装在一个500g罐中。
3患有胃肠道疾患(IBD,M.Crohn,脓毒病,食物过敏)的饮食制剂
口服再水合饮品,每升含有:
5g酵母膏
3g D(-)核糖
5g麦芽糖糊精DH10
600μg叶酸
5μg氰钴胺素
20mg硫酸锌
4mg氯化铜
300mg磷酸镁
1g乳清酸
5g谷氨酰谷氨酸
160μg亚硒酸钠
3.妊娠或哺乳妇女的药物制剂
体积为200ml的杯子,其包含一种基于脱脂奶粉的布丁,其每200ml中包含:
3g D-核糖
400μg叶酸
4μg氰钴胺素
4mg吡哆胺
100mg氯化镁
25mg柠檬酸锌
0.4g甲硫氨酸
10g麦芽糖糊精
1g胶质
4.患有血管疾患(心血管疾病,动脉硬化,脑血管疾病,梗塞,腿部供血不足,脉管性质差)的病人的补剂
条状物(重约28g配料,包括水分),其包含:
15g葡萄糖浆
4g D-核糖
400μg叶酸
3μg氰钴胺素
30mg硫酸锌
250mg碳酸镁
3mg吡哆胺
2g盐酸精氨酸
2g干水果(苹果,梨和杏)
2g谷物片(黑麦,小麦,燕麦)
5g坚果块混合物(榛子)
1g肌酸
30mgα-生育酚
50mg抗坏血酸
20mg辅酶Q10
5.在肝硬化,酗酒,肝炎等情况中支持肝功能的制剂
5g酵母膏
3g D(-)核糖
2g谷氨酰胺
10g麦芽糖糊精DH19
400μg叶酸
4μg氰钴胺素
3mg吡哆醇
1g精氨酸
2g乳清酸钠
1g天冬氨酸
2mg盐酸硫胺素
40mg碳酸锌
4mg碳酸铜
150ug硒酸钾
6.老年人饮用的汤
一种汤的脱水浓缩物,制备自:
5g粉末状椰菜提取物,提供180μg叶酸,
5g粉末状酵母膏,提供100μg叶酸和3g核糖
200μg叶酸
1g D(-)核糖
3μg氰钴胺素
0.5g氯化钠
0.4g氯化钾
1g脱水胡萝卜片
1g脱水洋葱片
20mg硫酸锌
2g麦芽糖糊精
7.针对早产儿的完全配方以降低黄疸危险
降低黄疸危险的婴儿配方,每100g粉末中包含:
12.4g蛋白质等价物,呈乳清蛋白/酪蛋白60/40w/w形式
54.8g可消化的碳水化合物,其中有2g D(-)核糖
21.1g脂质
5g纤维素
除了110μg叶酸之外,还包含本领域已知的标准量的痕量元素,矿物质和维生素
8.改善免疫功能的补剂
改善免疫功能的小饼
一种基于小麦的小饼,每30g包含:
2g谷氨酰胺
3g核糖
10g麦芽糖糊精,其包含200μg二十二碳六烯酸,200μg十二碳五烯酸和100μg花生四烯酸
20mg锌
100mg镁
400μg叶酸
3μg氰钴胺素
4mg铜
0.3g柠檬酸
9.预防和治疗骨关节炎的粉末,每40g包含:
300μg叶酸
4g D(-)核糖
0.5g甲硫氨酸
2μg氰钴胺素
0.8g柠檬酸钠
0.5g组氨酸
4mg盐酸吡哆醇
14mg锌
200mg镁
200mg硫酸盐
9g酪蛋白
20g麦芽糖糊精
4g大豆卵磷脂
Claims (22)
1.核糖和叶酸的组合在制备用于改善提供核糖和叶酸的总核苷酸代谢的药物或营养组合物中的应用,其中所述组合物每日剂量单位包含至少0.5g直至40g的核糖。
2.权利要求1的应用,其中所述组合物每日剂量单位包含1g-40g核糖,和每日剂量单位100μg-20mg叶酸。
3.权利要求1或2的应用,其中所述组合物每日剂量单位进一步包含0.2-3.0g组氨酸。
4.权利要求1或2的应用,其中所述组合物每日剂量单位进一步包含1-50g葡萄糖。
5.一种营养组合物,其包含适于支持总核苷酸代谢的核糖和叶酸,每日剂量单位包含至少0.5g直至40g的核糖和至少400μg的叶酸。
6.一种营养组合物,其包含适于支持总核苷酸代谢的核糖和叶酸,每日剂量单位包含至少0.5g直至40g的核糖和至少100μg的叶酸,所述组合物每日剂量单位或每5g核糖还含有一或多种如下物质:
1-50g的葡萄糖或其等价物;
0.1-8g的乳清酸;
0.1-6g的柠檬酸盐。
7.权利要求6的营养组合物,所述有效量是每日剂量单位1g-40g游离核糖,和每日剂量单位250μg-20mg叶酸。
8.权利要求5-7任一项的营养组合物,还包含选自以下的至少一种成分:镁,乳清酸,烟酸,硒,硫胺素,葡萄糖,柠檬酸盐,组氨酸,磷酸盐,硫酸盐,和维生素B12。
9.权利要求8的营养组合物,每日剂量单位或每5g核糖含有4-200mg烟酸等价物。
10.权利要求8的营养组合物,每日剂量单位或每5g核糖还包含大于0.3g组氨酸。
11.权利要求5-7任一项的营养组合物,每日剂量单位或每5g核糖还包含5-120g蛋白质。
12.权利要求5-7任一项的营养组合物,每日剂量单位或每5g核糖还包含大于0.5g谷氨酰胺,和/或大于1g天冬氨酸和/或大于1g精氨酸。
13.权利要求5-7任一项的营养组合物,每日剂量单位还包含大于2g氨基酸或氨基酸等价物的混合物,所述混合物含有3-10wt%组氨酸,5-15wt%异亮氨酸,10-23wt%亮氨酸,10-23wt%赖氨酸,5-15wt%甲硫氨酸,5-15wt%苯丙氨酸和5-15wt%苏氨酸。
14.权利要求13的营养组合物,其每日剂量单位包含大于4g氨基酸或氨基酸等价物的混合物。
15.权利要求13的营养组合物,其中所述组氨酸,谷氨酰胺,天冬氨酸和/或精氨酸至少50%是以游离氨基酸或二肽形式存在的。
16.权利要求5-7任一项的营养组合物,其含有葡萄糖,葡萄糖与核糖的重量比是0.1-50。
17.权利要求16的营养组合物,其中葡萄糖与核糖的重量比是0.2-10。
18.权利要求5-7任一项的营养组合物,是食物补剂形式。
19.权利要求5-7任一项的营养组合物,其适于改善免疫功能,每日剂量单位还含有大于500mg的ω-3多不饱和脂肪酸。
20.权利要求5-7任一项的营养组合物,其适于改善免疫功能,每日剂量单位还含有1-10g的谷氨酰胺。
21.权利要求5-7任一项的营养组合物,其适于改善疟疾或神经疾病,每日剂量单位还含有0.3-10mg的维生素B6。
22.权利要求5-7任一项的营养组合物,其适于预防或治疗心血管疾病,其还包含选自以下一组的至少一种成分:肉毒碱,肌酸,辅酶Q10,牛磺酸,甜菜碱,α-硫辛酸,维生素B6,维生素B12,锌和镁。
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US09/566,381 | 2000-05-08 | ||
US09/566,381 US6420342B1 (en) | 2000-05-08 | 2000-05-08 | Nutritional preparation comprising ribose and medical use thereof |
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CN1304009C true CN1304009C (zh) | 2007-03-14 |
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CNB018091776A Expired - Fee Related CN1304009C (zh) | 2000-05-08 | 2001-05-08 | 包含核糖和叶酸的营养制剂及其药用 |
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US (2) | US6420342B1 (zh) |
EP (1) | EP1282426A1 (zh) |
JP (1) | JP2003532679A (zh) |
CN (1) | CN1304009C (zh) |
AU (1) | AU2001256856A1 (zh) |
HK (1) | HK1049625A1 (zh) |
WO (1) | WO2001085178A1 (zh) |
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WO2001085178A1 (en) | 2001-11-15 |
US6420342B1 (en) | 2002-07-16 |
JP2003532679A (ja) | 2003-11-05 |
US6548483B2 (en) | 2003-04-15 |
AU2001256856A1 (en) | 2001-11-20 |
US20020183263A1 (en) | 2002-12-05 |
EP1282426A1 (en) | 2003-02-12 |
HK1049625A1 (zh) | 2003-05-23 |
CN1429113A (zh) | 2003-07-09 |
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