CN109069534B - 认知功能改善剂 - Google Patents
认知功能改善剂 Download PDFInfo
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- CN109069534B CN109069534B CN201780023085.7A CN201780023085A CN109069534B CN 109069534 B CN109069534 B CN 109069534B CN 201780023085 A CN201780023085 A CN 201780023085A CN 109069534 B CN109069534 B CN 109069534B
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- vitamin
- cognitive function
- present
- zinc
- improving agent
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Abstract
本发明提供一种以维生素A、维生素B群(B1、B2、B6及B12)、维生素C、维生素D、维生素E、锌、镁、泛酸、生物素及叶酸为有效成分的认知功能改善剂,并提供一种改善认知功能的方法,其包含将维生素A、维生素B群(B1、B2、B6及B12)、维生素C、维生素D、维生素E、锌、镁、泛酸、生物素及叶酸投予哺乳动物的步骤。
Description
技术领域
本发明涉及一种认知功能改善剂以及改善认知功能的方法。
背景技术
在日本,随着人口的高龄化,失智症的患者日益增加而成为社会的巨大问题。并且,由于失智症的前阶段为MCI(Mild Cognitive Impairment,轻度认知障碍),因此被认为存在相当数量的MCI高龄患者。
MCI是处于失智症与健全者的中间阶段(灰色地带)的症状,是认知功能(记忆、判断、合理化、实行等)内其中一项产生问题,但不影响日常生活的状态。若将MCI置之不理,认知功能会持续降低,约有半数将进入失智症的阶段。由于目前失智症大部份都无法完全治好,因此在MCI的阶段进行适当预防,防止症状的进展极为重要。
失智症的种类主要有阿兹海默型失智症、路易氏体失智症、血管型失智症及额颞叶型失智症这4种。
其中,以阿兹海默症为失智症中最多,占了老年期的失智症的一半以上。并且,阿兹海默症的特征为从初老期至老年期所发生的进行性的痴呆。现在于日本国内的患者数为300万人以上。阿兹海默症的临床症状为记忆障碍、高阶脑功能障碍(失用症、失认症、失语症、结构型失用症等)等。阿兹海默症被认为其原因在于:由于脑内β类淀粉蛋白及Tau蛋白的累积,导致神经细胞死亡。
目前,对于失智症使用4剂的抗失智症药(多耐派齐(donepezil)、美金刚胺(memantine)、加兰他敏(galantamine)、及利巴斯狄明(rivastigmine))。一般而言,经由投予这4剂内的1剂或2剂,可使失智症的进行延迟数年。
为了使脑顺利发挥功能,作为能量源的充足ATP(三磷酸腺苷)是必要的,而多数的失智症患者,此ATP的产生有所下降。ATP的产生于40岁以后逐年下降,若以40岁时为百分之100,在80岁时则仅有6成。ATP量的降低促进了认知功能的降低(即失智症容易发病),然而抗失智症的4剂药虽增加脑内的乙酰胆碱,却无法提升ATP量。进一步,脑循环/代谢改善剂由于促进ATP产生因此可被使用,但其具有现行中只能用于脑梗塞等器官障碍后的缺点。
此外,已公开了可使用与磷脂酰丝胺酸复合的银杏提取物,作为改善失智症及阿兹海默症的食品或医药的有效成分(专利文献1)。另一方面,将维生素B、维生素C、维生素E、β-胡萝卜素、叶酸等单独一种或多种(约2~3种)组合的补充剂,已被报导对认知功能的改善并不有效。
现有技术文献
专利文献
专利文献1:日本专利第5300196号公报
非专利文献
非专利文献1:Art S,et al,Neurochem Res 37:2706-2714,2012
非专利文献2:Petersen RC,et al,N Engl J Med 352:2379-2388,2005
非专利文献3:Kang JH,et al,Circulation 119:2772-2780,2009
非专利文献4:Aisen PS,et al,JAMA 300:1774-1783,2008
非专利文献5:van Uffelen JG,et al,Br J Sports Med 42:344-351,2008
发明内容
发明所要解决的问题
本发明目的在于提供一种具有认知功能的改善效果的认知功能改善剂及一种改善认知功能的方法。
用于解决问题的方案
如前所述,经由目前抗失智症药的失智症治疗无法呈现充分成果的根本原因在于:无法提升ATP的产生。ATP经由TCA循环的7阶段的反应而产生,而作为各反应的补酶的维生素类扮演重要角色。即,维生素类的充分补充可促进ATP的产生。
本发明人为达成上述目的而重复深入研究的结果,得到可经由含有维生素A、维生素B群(B1、B2、B6及B12)、维生素C、维生素D、维生素E、锌、镁、泛酸、生物素及叶酸的补充剂达成上述目的的见解。
本发明基于这样的见解,进一步重复探讨而完成,并提供下述认知功能改善剂。
第1项:一种认知功能改善剂,其以维生素A、维生素B群(B1、B2、B6及B12)、维生素C、维生素D、维生素E、锌、镁、泛酸、生物素及叶酸作为有效成分。
第2项:如第1项所述的认知功能改善剂,其中,维生素D的含量为0.0008质量%以上。
第3项:如第1或2项所述的认知功能改善剂,其中,维生素A的含量为0.085质量%以下。
第4项:如第1至3项所述的认知功能改善剂,其中,锌的含量为0.35质量%以下。
第5项:一种在认知功能改善剂(认知功能改善用保健用食品)的制造中,使用维生素A、维生素B群(B1、B2、B6及B12)、维生素C、维生素D、维生素E、锌、镁、泛酸、生物素及叶酸的方法。
第6项:一种改善认知功能的方法,其包含将维生素A、维生素B群(B1、B2、B6及B12)、维生素C、维生素D、维生素E、锌、镁、泛酸、生物素及叶酸投予哺乳动物的步骤。
第7项:一种认知功能改善用组合物,其含有维生素A、维生素B群(B1、B2、B6及B12)、维生素C、维生素D、维生素E、锌、镁、泛酸、生物素及叶酸。
发明效果
本发明的认知功能改善剂具有MCI及失智症的患者的认知功能的改善效果。
本发明的认知功能改善剂虽单独使用的效果也可期待,但经由与抗失智症治疗药的并用,可期待有效地延迟失智症的进行,及认知功能的改善。进一步,本发明的认知功能改善剂对维持MCI及失智症患者的ADL(日常生活活动)也可期待。
具体实施方式
以下,对本发明进行详细说明。
需要说明的是,本说明书中的“包含(comprise)”包含“实质上由…组成(essentially consist of))”的意思及“由…组成(consist of)”的意思。
本发明的认知功能改善剂的特征在于以(或包含)维生素A、维生素B群(B1、B2、B6及B12)、维生素C、维生素D、维生素E、锌、镁、泛酸、生物素及叶酸为有效成分。
本发明的维生素A包含:维生素A1(视网醇)、视网醇、视网酸、维生素A2(3-脱氢视网醇)、3-脱氢视网醇、3-脱氢视网酸、它们的诱导体、它们的酯体、原维生素A、它们的盐等。酯体可列举:与各种脂肪酸的酯体(维生素A醋酸酯等);原维生素A可列举:α-胡萝卜素、β-胡萝卜素、γ-胡萝卜素、δ-胡萝卜素、茄红素、玉米黄素、β-隐黄素、海胆烯酮(echinenone)等。维生素A可单独使用1种或组合2种以上而使用。本发明的维生素A可使用从天然物分离物及化学合成物中任一种。
本发明的维生素B1包含硫胺素及其盐等。本发明的维生素B1可使用从天然物分离物及化学合成物中任一种。
本发明的维生素B2包含核黄素及其盐等。本发明的维生素B2可使用从天然物分离物及化学合成物中任一种。
本发明的维生素B6包含吡哆醇、吡哆醛、吡哆胺、及它们的盐等。维生素B6可单独使用1种或组合2种以上而使用。本发明的维生素B6可使用从天然物分离物及化学合成物中任一种。
本发明的维生素B12包含钴铵、羟钴铵、腺苷钴胺、甲基钴铵、氰钴铵、亚硫酸钴胺及它们的盐等。维生素B12可单独使用1种或组合2种以上而使用。本发明的维生素B12可使用从天然物分离物及化学合成物中任一种。
本发明的维生素C包含抗坏血酸及其盐等。本发明的维生素C可使用从天然物分离物及化学合成物中任一种。
本发明的维生素D(钙化醇)包含维生素D2~D7及它们的盐等。本发明的维生素D优选为维生素D2、维生素D3、原维生素D2及原维生素D3。维生素D可单独使用1种或组合2种以上而使用。本发明的维生素D可使用从天然物分离物及化学合成物中任一种。
本发明的维生素E包含α-生育酚、β-生育酚、γ-生育酚、δ-生育酚、α-生育三烯醇、β-生育三烯醇、γ-生育三烯醇、δ-生育三烯醇及它们的盐等。维生素E可单独使用1种或组合2种以上而使用。本发明的维生素E可使用从天然物分离物及化学合成物中任一种。
本发明的镁包含镁及其盐等。镁盐可列举:氧化镁、氯化镁、碳酸镁、硫酸镁等。镁可单独使用1种或组合2种以上而使用。本发明的镁可使用从天然物分离物及化学合成物中任一种。
本发明的锌包含锌及其盐等。锌的有机酸盐可列举焦磷酸锌、柠檬酸锌、琥珀酸锌、葡萄糖酸锌等;锌的无机酸盐可列举氯化锌、硫酸锌等。锌可单独使用1种或组合2种以上而使用。本发明的锌可使用从天然物分离物及化学合成物中任一种。此外,本发明的锌也可直接使用锌酵母、牡蛎等含锌的原材料,或使用其经粗精制的物质。
本发明的泛酸包含泛酸及其盐等。本发明的泛酸可使用从天然物分离物及化学合成物中任一种。
本发明的生物素包含生物素及其盐等。本发明的生物素可使用从天然物分离物及化学合成物中任一种。此外,本发明的生物素也可直接使用含有生物素的酵母等含生物素的原材料,或使用其经粗精制的物质。
本发明的叶酸包含叶酸、叶酸的诱导体、它们的盐等。本发明的叶酸可使用从天然物分离物及化学合成物中任一种。
本发明的认知功能改善剂中,维生素A、维生素B群(B1、B2、B6及B12)、维生素C、维生素D、维生素E、锌、镁、泛酸、生物素及叶酸的含量无特别限制,例如,可根据后述的成人每天的摄取量设定为各有效成分的含量。
本发明的认知功能改善剂中维生素A的含量无特别限定,优选为0.00001质量%以上,且进一步优选为0.0001质量%以上;优选为0.085质量%以下,且进一步优选为0.0085质量%以下。
本发明的认知功能改善剂中维生素D的含量无特别限定,优选为0.0008质量%以上,且进一步优选为0.0010质量%以上;优选为0.0068质量%以下,且进一步优选为0.0021质量%以下。
本发明的认知功能改善剂中锌的含量无特别限定,优选为0.0001质量%以上,且进一步优选为0.001质量%以上;优选为0.35质量%以下,且进一步优选为0.28质量%以下。
本发明的认知功能改善剂的含义也包含医药品、医药部外品及饮食品(例如健康食品、营养组合物(nutritional composition)、营养补助食品、功能性食品、营养补助食品、补充剂、保健用食品、特定保健用食品、营养功能食品、功能性表示食品等)。此外,本发明的认知功能改善剂的含义也包含赋予认知功能改善作用的添加剂。
就上述饮食品而言,根据需求,除上述的有效成分外,也可根据需求而配混矿物质类、维生素类、类黄酮类、醌类、多酚类、氨基酸、核酸、必需脂肪酸、酵素、淀粉、食用油脂、甜味剂、酸味剂、苦味剂、调味料、色素、香料、保存剂、漂白剂、加工剂、清凉剂、增粘剂、乳化剂、稳定剂、防腐剂、膨胀剂、表面活性剂、粘结剂、溶解剂、湿润剂、赋形剂、润滑剂、结合剂、崩解剂、抗氧化剂、pH调整剂、光泽剂、胶剂等。
上述饮食品的种类包含哺乳动物(包含人)可摄取的所有饮食品,例如,可列举乳制品;发酵食品(优格、奶酪等);饮料类(咖啡、果汁、可可亚、茶饮料、运动饮料、如能量饮料的清凉饮料、乳饮料、乳酸菌饮料、添加乳酸菌饮料、优格饮料、碳酸饮料、如日本酒、洋酒、果实酒的酒等);抹酱类(卡士达糊等);酱类(水果酱等);西式点心类(巧克力、甜甜圈、派、鲜奶油、口香糖、软糖、果冻、糖果、甜饼干、蛋糕、布丁、饼干等);日式点心类(大福、麻糬、馒头、卡斯特拉、馅蜜、羊羹、仙贝、米菓、糖等);冰点心(冰淇淋、棒冰、雪酪等);食品类(咖哩、牛丼、杂炊、味噌汤、汤、肉酱、意大利面、腌渍物、酱、火腿、香肠、培根等);调味料类(色拉酱、拌饭素、增味剂、汤块、味噌、酱油、酱汁、西红柿酱、蚝油等)等。
作为补充剂等使用时的投药剂型形态,并无特别限制,可适当选择适合形态。例如,可列举锭剂(例如裸锭、糖衣锭、膜衣锭、咀嚼锭、口含锭等)、胶囊剂、细粒剂、颗粒剂、液剂、散剂、糖浆、药膏、饮剂等。
上述饮食品的制法并无特别限制,可适当遵循公知的方法。
就本发明的认知功能改善剂的摄取量而言,可根据摄取者的体重、年龄、性别、症状等各种条件而适当设定。对于成人每天的本发明的认知功能改善剂的各有效成分的摄取量,并无特别限制,例如,可列举下述量:
维生素A:优选为50~3000μg,进一步优选为50~300μg。
维生素B1:优选为25~200mg,进一步优选为50~150mg。
维生素B2:优选为10~100mg,进一步优选为20~60mg。
维生素B6:优选为10~100mg,进一步优选为20~60mg。
维生素B12:优选为100~1500μg,进一步优选为450~1000μg。
维生素C:优选为100~5000mg,进一步优选为1000~3000mg。
维生素D:优选为5~250μg,进一步优选为10~75μg。
维生素E:优选为50~800mg,进一步优选为67~400mg。
锌:优选为2~12mg,进一步优选为3~10mg。
镁:优选为5~100mg,进一步优选为10~80mg。
泛酸:优选为50~400mg,进一步优选为120~300mg。
生物素:优选为50~500μg,进一步优选为150~450μg。
叶酸:优选为100~1500μg,进一步优选为450~1200μg。
在本发明的认知功能改善剂制备为医药部外品或医药品时,可将上述有效成分与医药品中可容许的无毒性载体、稀释剂或赋形剂一同制备为锭剂(包含裸锭、糖衣锭、发泡锭、膜衣锭、咀嚼锭、口含锭等)、胶囊剂、丸剂、粉末剂(散剂)、细粒剂、颗粒剂、液剂、悬浮液、乳化液、糖浆、药膏、注射剂(包含使用时,配混蒸馏水、胺基酸输液、电解质输液等制备为液剂的情形)等形态,作为医药用的制剂。
上述医药部外品或医药品的投予方式并无特别限定,例如,可经由动脉投药、静脉投药、口颊投药、直肠投药、肠道投药、经皮投药、口服投药等而施行。
就上述医药部外品或医药品的投予剂量而言,可根据患者的体重、年龄、性别、症状等各种条件而适当决定,成人每人的本发明的认知功能改善剂的各有效成分的投予量并无特别限制,例如,可列举上述量。
本发明的认知功能改善剂经由使用维生素A、维生素B群(B1、B2、B6及B12)、维生素C、维生素D、维生素E、锌、镁、泛酸、生物素及叶酸这10种成分的组合,得到认知功能(特别是对于pre-MCI、MCI及失智症的患者)改善效果。本发明虽不预期被任何理论所限制,但推测以这10种有效成分的补充可促进ATP产生,从而经由脑内环境的改善而获得该效果。
因此,本发明的认知功能改善剂以认知功能的改善为目的而被使用。在此,“认知功能”意指失智症中观察到有障碍的功能。“认知功能”可列举记忆力、注意力、语言功能、在身体进行一连续动作的功能、通过五感把握周围状况的功能、执行功能、定向力等。“失智症”是指因后天性脑器官障碍,使一度正常发展的知能不可逆地降低的状态。在此,“改善”也包含症状进一步恶化的防止,即维持。
本发明的认知功能改善剂的适用对象可列举失智症(特别是阿兹海默症)的患者、MCI的患者、pre-MCI的患者等,但适用对象也包含以认知功能的维持为目的,而认知功能并无问题的高龄者。此外,本发明的认知功能改善剂适用于包含人类的哺乳动物。
本发明的认知功能改善剂虽单独使用的效果也可期待,但经由与抗失智症治疗药(多耐派齐(Donepezil)、美金刚胺(memantine)、加兰他敏(galantamine)、及利巴斯狄明(rivastigmine))的并用,可期待有效地延迟失智症的进行,及认知功能的改善。进一步,本发明的认知功能改善剂对维持MCI及失智症患者的ADL(日常生活活动)也可期待。
实施例
以下,为了进一步详细说明本发明而列举实施例。然而,本发明不限定于这些实施例。
试验例
以10症例进行关于本发明的认知功能改善剂的试验。试验例10例中,7症例为主观健忘及易疲劳性的Pre-MCI患者,且3症例(No2、No3、No10)有主观健忘及易疲劳性症状,并在MMSE*1检查及影像诊断上也被诊断为Pre-MCI、MCI或失智症。在获得投予大量维生素的同意的上对此10病例投予所定的维生素量而观察其进程。具体而言,投予受试者下述表1所示组成的胶囊剂。
*1MMSE检查是指作为失智症的筛检测验而在世界广泛使用的检查,由11个问题项目组成,若全部问题正确则得30分。
【表1】
在本试验中,各受试者在胶囊剂的投予前及一定期间的投予后,接受医师的诊断或面谈。
所得结果如表2所示。
【表2】
MMSE及影像检查中被诊断为Pre-MCI、MCI或失智症的3症例,原本为需服用爱忆欣8-10mg、利忆灵16-24mg、美忆15-20mg程度的症例。然而,经由使用本发明的认知功能改善剂,可停留于现行的药物使用量。此外,除了认知功能,大部分的症例在表情的丰富度、身体敏捷性、疲劳、意志力等有所改善,因此可认为有脑血液循环的显着改善。
其他7位健全者在其他维生素下虽无显著改善,在本剂下也有特别明显的认知功能改善、疲劳恢复、眼睛疲劳恢复。
Claims (4)
1.一种维生素A、维生素B1、维生素B2、维生素B6、维生素B12、维生素C、维生素D、维生素E、锌、镁、泛酸、生物素及叶酸在制造认知功能改善剂中的应用,其特征在于,
所述认知功能改善剂中仅使用维生素A、维生素B1、维生素B2、维生素B6、维生素B12、维生素C、维生素D、维生素E、锌、镁、泛酸、生物素及叶酸作为有效成分,且以成人每天的摄取量为以下范围的含量含有有效成分:
维生素A:50~3000μg;
维生素B1:25~200mg;
维生素B2:10~100mg;
维生素B6:10~100mg;
维生素B12:100~1500μg;
维生素C:100~5000mg;
维生素D:5~250μg;
维生素E:50~800mg;
锌:2~12mg;
镁:5~100mg;
泛酸:50~400mg;
生物素:50~500μg;
叶酸:100~1500μg。
2.根据权利要求1所述的应用,其中,认知功能改善剂中的维生素D的含量为0.0008质量%以上。
3.根据权利要求1或2所述的应用,其中,认知功能改善剂中的维生素A的含量为0.085质量%以下。
4.根据权利要求1或2所述的应用,其中,认知功能改善剂中的锌的含量为0.35质量%以下。
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