CN115443074A - 营养配制品 - Google Patents
营养配制品 Download PDFInfo
- Publication number
- CN115443074A CN115443074A CN202180001580.4A CN202180001580A CN115443074A CN 115443074 A CN115443074 A CN 115443074A CN 202180001580 A CN202180001580 A CN 202180001580A CN 115443074 A CN115443074 A CN 115443074A
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- CN
- China
- Prior art keywords
- choline
- nutritional formulation
- phosphatidylcholine
- formulation
- weight
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
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- 235000016709 nutrition Nutrition 0.000 title claims abstract description 25
- 239000000203 mixture Substances 0.000 title claims description 48
- 238000009472 formulation Methods 0.000 title claims description 35
- OEYIOHPDSNJKLS-UHFFFAOYSA-N choline Chemical compound C[N+](C)(C)CCO OEYIOHPDSNJKLS-UHFFFAOYSA-N 0.000 claims abstract description 50
- 229960001231 choline Drugs 0.000 claims abstract description 49
- WTJKGGKOPKCXLL-RRHRGVEJSA-N phosphatidylcholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCCCCCCC=CCCCCCCCC WTJKGGKOPKCXLL-RRHRGVEJSA-N 0.000 claims abstract description 33
- RZZPDXZPRHQOCG-OJAKKHQRSA-M CDP-choline(1-) Chemical compound O[C@@H]1[C@H](O)[C@@H](COP([O-])(=O)OP([O-])(=O)OCC[N+](C)(C)C)O[C@H]1N1C(=O)N=C(N)C=C1 RZZPDXZPRHQOCG-OJAKKHQRSA-M 0.000 claims abstract description 15
- 229960001284 citicoline Drugs 0.000 claims abstract description 15
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- 230000002195 synergetic effect Effects 0.000 claims abstract description 4
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- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 claims description 22
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- A—HUMAN NECESSITIES
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Abstract
本发明公开了一种包含磷脂酰胆碱、胞苷二磷酸胆碱和甘磷酸胆碱的营养配制品，其特征在于，磷脂酰胆碱与胞苷二磷酸胆碱和甘磷酸胆碱的组合在提高胆碱生物利用度以支持认知功能和细胞健康方面具有协同效应。
Description
技术领域
本发明整体涉及营养配制品。特别地，本发明描述了包含三种类型的含胆碱分子的营养配制品，用于支持健康的细胞膜、认知功能、脂质转运和血浆高半胱氨酸的减少。
背景技术
胆碱是通过膳食摄入和内源性合成而获得的营养物质。我们的身体需要胆碱来合成磷脂酰胆碱和鞘磷脂，这是对于细胞膜至关重要的两种主要磷脂。磷脂酰胆碱(PC)是含有两个脂肪酸的分子，这些脂肪酸通过磷酸基团和胆碱连接到甘油主链上。所有的植物细胞和动物细胞都需要胆碱来保持其结构完整性。此外，胆碱是产生乙酰胆碱所必需的，乙酰胆碱是用于记忆、情绪、肌肉控制以及其他的脑和神经系统功能的重要神经递质。
关于胆碱代谢链，胆碱先转化为磷酸胆碱，然后转化为胞苷二磷酸胆碱(CDP胆碱)。磷酸胆碱转化为CDP胆碱是胆碱代谢链中最慢的步骤。CDP胆碱是在限速步骤之后产生的胆碱形式，并且具有穿过血脑屏障到达中枢神经系统的能力。
甘磷酸胆碱(αGPC)在体内通过磷脂酰胆碱的分解而获得。胆碱途径中的酶反应是双向的，因此αGPC的强化允许磷脂酰胆碱用于其他目的，而不是分解成胆碱。αGPC在胆碱途径的不同位点处进入胆碱池，并且还具有穿过血脑屏障到达中枢神经系统的能力。
本发明提出了一种营养配制品，其作为膳食补充剂来增加对于神经递质乙酰胆碱的合成必不可少的游离胆碱的生物利用度，并且支持健康的细胞膜、认知功能、脂质转运和血浆高半胱氨酸的减少。
发明内容
本发明的一个实施方案提供了一种营养配制品，其包含磷脂酰胆碱、胞苷二磷酸胆碱和甘磷酸胆碱，其特征在于，磷脂酰胆碱与胞苷二磷酸胆碱和甘磷酸胆碱的组合在提高胆碱生物利用度以支持认知功能和细胞健康方面具有协同效应。
优选地，该配制品还包含α生育酚。
优选地，每次摄入的磷脂酰胆碱重量为100mg至1000mg。
优选地，每次摄入的胞苷二磷酸胆碱重量为50mg至250mg。
优选地，每次摄入的甘磷酸胆碱重量为50mg至600mg。
优选地，每次摄入的α生育酚重量为10mg至30mg。
本发明的另一个实施方案提供了包含磷脂酰胆碱、胞苷二磷酸胆碱和甘磷酸胆碱的营养配制品的用途，其用于治疗与β-淀粉样蛋白的聚集相关的疾病或病症、阿尔茨海默氏病、中风，改善血脑屏障功能、改善活性剂穿过血脑屏障的血脑屏障转运、改善或维持认知健康、提供神经保护、促进神经发育或促进脑代谢，使得前述病症中的一者或多者得到治疗、改善或帮助。
优选地，该配制品还包含α生育酚。
优选地，每次摄入的磷脂酰胆碱重量为100mg至1000mg。
优选地，每次摄入的胞苷二磷酸胆碱重量为50mg至250mg。
优选地，每次摄入的甘磷酸胆碱重量为50mg至600mg。
优选地，每次摄入的α生育酚重量为10mg至30mg。
本发明可以在不脱离其本质特征的前提下以其他特定形式实施。所描述的实施方案在所有方面都应被认为仅是说明性的而非限制性的。因此，本发明的范围由所附权利要求书而不是由前面的描述来指示。在权利要求书的等同形式的含义和范围内的所有变化都将被包含在其范围内。
具体实施方式
本发明整体涉及营养配制品。特别地，本发明描述了由三种类型的含胆碱分子组成的营养配制品，用于支持健康的细胞膜、认知功能、脂质转运和血浆高半胱氨酸的减少。
在下文中，根据本发明的“营养配制品”将根据优选实施方案进行详细描述。应当理解，将描述限于本发明的优选实施方案仅仅是为了便于讨论本发明，并且在不脱离所附权利要求书的范围的前提下可以预见这种情况。
本发明公开了包含三种主要活性成分连同α生育酚的组合的营养配制品，这三种主要活性成分是三种类型的含胆碱分子，诸如甘磷酸胆碱(αGPC)、胞苷二磷酸胆碱(CDP胆碱)和磷脂酰胆碱。
胆碱是通过膳食摄入和内源性合成而获得的营养物质，其用于神经递质乙酰胆碱的合成，并且还参与甲基代谢，特别是肝脏中的甲基代谢，因为它是甲基的主要膳食来源，经由其不可逆氧化为甜菜碱，随后合成S-腺苷甲硫氨酸，而提供甲基。
肝脏是胆碱代谢的主要场所，在那里胆碱主要以磷脂酰胆碱的形式存在，胆碱对于维持肝脏内的磷脂酰胆碱供应很重要。
通过参见胆碱代谢链，胆碱最初使用ATP作为磷酸供体，被胆碱激酶(CK)转化为磷酸胆碱。一种称为磷酸胆碱胞苷酰转移酶(CCT)的酶使用胞苷三磷酸(CTP)将磷酸胆碱转化为CDP胆碱。磷酸胆碱转化为CDP胆碱是胆碱代谢链中最慢的步骤。CDP胆碱被包含在本发明的配制品中，因为它是在限速步骤之后产生的胆碱形式，并且具有穿过血脑屏障到达中枢神经系统的能力。
CDP胆碱不仅仅是胆碱来源；它含有等摩尔量的胆碱和胞苷，这将有助于增加体内的血浆尿苷核苷酸和胆碱。核苷酸尿苷是突触强度和神经连接性的关键因素。在本发明中，CDP胆碱用作核苷酸尿苷和益智成分的前体。尿苷连同CDP胆碱一起通过激活D1和D2受体信号传导来促进脑中新多巴胺受体的生长。
在该途径的最后一步中，CDP胆碱在胆碱磷酸转移酶(CEPT)的作用下与二酰基甘油(DAG)发生酯化，产生磷脂酰胆碱。必需脂肪酸诸如二十碳五烯酸(EPA)和二十二碳六烯酸(DHA)参与DAG的产生。磷脂酰胆碱是CDP胆碱途径的最终产物，身体和脑中的大多数胆碱都是磷脂酰胆碱的形式，它充当胆碱的储库。磷脂酰胆碱参与VLDL(极低密度脂蛋白)的肝脏转运和维持对于所有基本生物过程至关重要的细胞膜完整性。磷脂酰胆碱还充当出色的乳化剂，其有助于提高与其共同施用的营养物质(在这种情况下为αGPC、CDP胆碱和α生育酚)的生物利用度。
αGPC在体内通过磷脂酰胆碱的分解而获得。胆碱途径中的酶反应是双向的，配制品中αGPC的强化允许磷脂酰胆碱用于其他目的，而不是分解成胆碱。αGPC在胆碱途径的不同点处进入胆碱池，并且还具有穿过血脑屏障到达中枢神经系统的能力。在本发明中，αGPC充当强效的益智成分并且用于维持衰老的大脑对胆碱的摄取。
除了能够穿过血脑屏障直接增加中枢神经系统内的乙酰胆碱水平之外，αGPC还具有独特的作用。αGPC还充当神经元细胞磷脂生物合成的前体，并且进一步扩充胆碱池以产生甜菜碱，其功能是降低血液中的高半胱氨酸水平。
不同的动力学和与胆碱途径的相互作用，配制品中αGPC的强化和CDP胆碱将允许CDP胆碱途径的上调和磷脂酰胆碱循环的周转；然后允许磷脂酰胆碱被用于脂质转运，形成磷脂酰丝氨酸、鞘磷脂，以及支持细胞膜结构和功能而不是分解以扩充胆碱池，并且还为乙酰胆碱合成和其他代谢功能提供更高的胆碱可用性。
另外，该配制品还包含活性形式的脂溶性抗氧化剂，诸如α生育酚。α生育酚的主要生物学作用是保护多不饱和脂肪和细胞膜的其他组分免受活性氧和自由基的影响。α生育酚在支持神经功能、心血管健康和肝脏中发挥各种作用，主要是通过保护细胞免受与氧化应激相关联的损伤。已经发现，α生育酚促进健康的脑老化、延缓阿尔茨海默氏病相关的功能衰退、增加体外抗氧化性、防止动脉粥样硬化斑块形成，并且防止由氧化损伤引起的肝脏纤维化。α生育酚充当抗氧化剂，保护细胞膜、蛋白质和DNA免受氧化，从而有助于细胞健康。
α生育酚为组合物提供了抗脂质氧化的稳定性，并且限制胆碱转化为三甲胺(TMA)和三甲胺N-氧化物(TMAO)，这将提高产品质量并且降低由高浓度胆碱引起副作用的风险。α生育酚的生物利用度也因为存在磷脂而增加。
每种成分都具有协同作用和独立作用，以支持细胞膜的结构完整性、甲基代谢、胆碱能神经传递、跨膜信号传导，以及脂质和胆固醇的转运和代谢。
成年人的一般充足胆碱摄入量为男性每天530mg，女性每天425mg，并且每日上限为每天3500mg。
本发明的营养配制品包含以下成分：
| 100mg–1000mg | 磷脂酰胆碱 |
| 50mg–250mg | CDP胆碱 |
| 50mg–600mg | αGPC |
| 10mg–30mg | α生育酚 |
a.磷脂酰胆碱按重量计提供13.7％的胆碱。
b.CDP胆碱按重量计提供21.4％的胆碱。
c.αGPC按重量计提供40.3％的胆碱。
研究发现证明，与接受安慰剂的青少年男性相比，补充250mg至500mg CDP胆碱显示出注意力改善、意识活动速度加快，以及冲动性降低(McGlade E、Agoston AM、DiMuzio J等人，The Effect of Citicoline Supplementation on Motor Speed and Attention inAdolescent Males(补充胞磷胆碱对青少年男性活动速度和注意力的影响)，Journal ofAttention Disorders(《注意力障碍杂志》)，2019；23(2):121-134.doi:10.1177/1087054715593633)。
以400mg每日三次分剂量补充αGPC并持续三个月的随机对照试验证明，治疗组与安慰剂组相比认知和功能得到改善(De Jesus Moreno Moreno M.Cognitive improvementin mild to moderate Alzheimer's dementia after treatment with theacetylcholine precursor choline alfoscerate:amulticenter,double-blind,randomized,placebo-controlled trial(用乙酰胆碱前体甘磷酸胆碱治疗后轻度至中度阿尔茨海默氏痴呆的认知改善：多中心、双盲、随机、安慰剂对照试验)，Clin Ther(《临床治疗学》)，2003年1月，25(1):178-93.doi:10.1016/s0149-2918(03)90023-3.PMID:12637119)。
双盲研究表明，正常大学生补充磷脂酰胆碱后，由于胆碱供应和胆碱能功能增加而改善了外显记忆(Ladd SL、Sommer SA、LaBerge S、Toscano W，Effect ofphosphatidylcholine on explicit memory(磷脂酰胆碱对外显记忆的影响)，ClinNeuropharmacol(《临床神经药理学》)，1993年12月，16(6):540-9.PMID:9377589)。
含有胆碱的组合物还特别地被配制用于脂质代谢、减少在中风诱导的神经损伤部位处的游离脂肪酸积聚、溶解血凝块、与β-淀粉样蛋白的聚集相关的病症，以及阿尔茨海默氏病。
优选的施用方法是口服，以允许配制品分剂量按给药间隔服用。本发明的组合物可以与合适的载体诸如淀粉、蔗糖或乳糖一起配制为片剂、胶囊剂、溶液剂、糖浆剂和乳剂。本发明的片剂或胶囊剂可以用肠溶衣来包衣，该肠溶衣在约6.0至7.0的pH下溶解。在小肠中溶解但不在胃中溶解的合适肠溶衣是邻苯二甲酸乙酸纤维素。
可以通过本领域中已知的许多方法将本发明的组合物配制成软凝胶胶囊。通常，配制品将包含可接受的载体，诸如油，或者其他悬浮剂或乳化剂。
合适的任选载体包括但不限于例如脂肪酸、其酯和盐，其可以衍生自任何来源，包括但不限于天然或合成的油、脂肪、蜡或它们的组合。此外，脂肪酸可以衍生自但不限于非氢化油、部分氢化油、完全氢化油或它们的组合。脂肪酸(它们的酯和盐)的非限制性示例性来源包括籽油、鱼油或海洋生物油、芥花油、植物油、红花油、向日葵油、旱金莲籽油、芥菜籽油、橄榄油、芝麻油、大豆油、玉米油、花生油、棉籽油、米糠油、巴巴苏坚果油、棕榈油、低芥酸菜籽油、棕榈仁油、羽扇豆油、椰子油、亚麻籽油、月见草油、荷荷巴油、小麦胚芽油、动物脂油、牛油、黄油、鸡油、猪油、乳制品乳脂、乳木果油或它们的组合。
具体的非限制性示例性鱼油或海洋生物油来源包括贝类油、金枪鱼油、鲭鱼油、鲑鱼油、鲱鱼油、鳀鱼、鲱鱼、鳟鱼、沙丁鱼或它们的组合。特别地，脂肪酸的来源是鱼油或海洋生物油(DHA或EPA)、大豆油或亚麻籽油。替代性地或与上文确认的载体之一结合，可以使用蜂蜡，以及悬浮剂诸如硅石(二氧化硅)作为合适的载体。
本发明的组合物可以还包含各种成分来帮助稳定本发明的有益组合物的组分、或帮助提高本发明的有益组合物的组分的生物利用度，或者充当个体膳食的附加营养物质。合适的添加剂可以包括维生素和生物学上可接受的矿物质。维生素的非限制性示例包括维生素A、维生素B、维生素C、维生素D、维生素K和叶酸。矿物质的非限制性示例包括铁、钙、镁、钾、铜、铬、锌、钼、碘、硼、硒、锰、它们的衍生物或它们的组合。这些维生素和矿物质可以来自任何来源或来源的组合，而没有限制。非限制性示例性维生素B包括但不限于硫胺素、烟酰胺、吡哆醇、核黄素、氰钴胺、生物素、泛酸或它们的组合。
可以将各种添加剂掺入到本发明的组合物中。本发明的组合物的任选添加剂包括但不限于透明质酸、淀粉、糖、脂肪、抗氧化剂、氨基酸、蛋白质、风味剂、着色剂、水解淀粉以及它们的衍生物或它们的组合。
包括本发明的组合物在内的组合物可以通过常规混合、溶解、制粒、糖衣丸研磨、乳化、包封、包埋或冻干过程的方法来制造。这些组合物可以使用一种或多种生理学上可接受的载体、稀释剂、赋形剂或助剂以常规方式配制，这些载体、稀释剂、赋形剂或助剂有助于将这些组合物加工成可以使用的制剂。
如本文所用，术语“抗氧化剂”是本领域认可的，是指防止或延迟化合物氧化变质的合成物质或天然物质。示例性抗氧化剂包括生育酚、黄酮类、儿茶素、超氧化物歧化酶、卵磷脂、γ谷维素；维生素，诸如维生素A、维生素C(抗坏血酸)和β-胡萝卜素；天然组分，诸如存在于迷迭香和山楂提取物中的卡诺醇(camosol)、迷迭香酸和迷迭香酚，原花青素，诸如存在于葡萄籽或松树皮提取物中的原花青素，以及绿茶提取物。
对于口服施用，本发明的组合物可以通过常规方法用药学上可接受的辅助药剂制备成锭剂、片剂或胶囊剂等，药学上可接受的辅助药剂可包括粘合剂(例如，预胶化玉蜀黍淀粉、聚乙烯吡咯烷酮或羟丙基甲基纤维素)；填充剂(例如，乳糖、微晶纤维素或磷酸氢钙)；润滑剂(例如，硬脂酸镁、滑石或硅石)；崩解剂(例如，马铃薯淀粉或羟基乙酸淀粉钠)；或润湿剂(例如，十二烷基硫酸钠)。片剂可以通过本领域中众所周知的方法，用例如糖、薄膜或肠溶衣来包衣。
可以适当地配制用于口服施用的制剂，以提供组合物的控释，这是众所周知的。
除非上下文另有要求或明确相反地说明，否则本文中作为单数形式的整体、步骤或要素叙述的本发明的整体、步骤或要素清楚地涵盖所叙述的整体、步骤或要素的单数形式和复数形式两者。
在本说明书通篇中，除非上下文另有要求，否则词语“包括”或诸如“包含”或“含有”之类的变型形式将被理解为暗示包括所陈述的步骤或要素或整体或者一组步骤或要素或整体，但不排除任何其他的步骤或要素或整体或者一组步骤、要素或整体。因此，在本说明书的上下文中，术语“包括”以包含的意义使用，因此应当被理解为“主要包括，但不一定仅包括”的意思。
Claims (12)
1.一种营养配制品，包含：
磷脂酰胆碱；
胞苷二磷酸胆碱；和
甘磷酸胆碱，
其特征在于，
磷脂酰胆碱与胞苷二磷酸胆碱和甘磷酸胆碱的组合在提高胆碱生物利用度以支持认知功能和细胞健康方面具有协同效应。
2.如权利要求1所述的营养配制品，其中所述配制品还包含α生育酚。
3.如权利要求1所述的营养配制品，其中每次摄入的磷脂酰胆碱重量为100mg至1000mg。
4.如权利要求1所述的营养配制品，其中每次摄入的胞苷二磷酸胆碱重量为50mg至250mg。
5.如权利要求1所述的营养配制品，其中每次摄入的甘磷酸胆碱重量为50mg至600mg。
6.如权利要求2所述的营养配制品，其中每次摄入的α生育酚重量为10mg至30mg。
7.包含磷脂酰胆碱、胞苷二磷酸胆碱和甘磷酸胆碱的营养配制品的用途，其用于治疗与β-淀粉样蛋白的聚集相关的疾病或病症、阿尔茨海默氏病、中风，改善血脑屏障功能、改善活性剂穿过血脑屏障的血脑屏障转运、改善或维持认知健康、提供神经保护、促进神经发育或促进脑代谢，使得前述病症中的一者或多者得到治疗、改善或帮助。
8.如权利要求7所述的营养配制品的用途，其中所述配制品还包含α生育酚。
9.如权利要求7所述的营养配制品的用途，其中每次摄入的磷脂酰胆碱重量为100mg至1000mg。
10.如权利要求7所述的营养配制品的用途，其中每次摄入的胞苷二磷酸胆碱重量为50mg至250mg。
11.如权利要求7所述的营养配制品的用途，其中每次摄入的甘磷酸胆碱重量为50mg至600mg。
12.如权利要求7所述的营养配制品的用途，其中每次摄入的α生育酚重量为10mg至30mg。
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| MYPI2021001876 | 2021-04-06 | ||
| MYPI2021001876 | 2021-04-06 | ||
| PCT/IB2021/054853 WO2022214861A1 (en) | 2021-04-06 | 2021-06-03 | A nutraceutical formulation |
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2021
- 2021-06-03 CN CN202180001580.4A patent/CN115443074A/zh active Pending
- 2021-06-03 EP EP21730452.6A patent/EP4090174A1/en active Pending
- 2021-06-03 WO PCT/IB2021/054853 patent/WO2022214861A1/en unknown
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| WO2022214861A1 (en) | 2022-10-13 |
| EP4090174A1 (en) | 2022-11-23 |
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