CN110507695A - Nadh和/或nmn在制备脑功能恢复的药物、保健品中的应用 - Google Patents
Nadh和/或nmn在制备脑功能恢复的药物、保健品中的应用 Download PDFInfo
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- CN110507695A CN110507695A CN201910776018.3A CN201910776018A CN110507695A CN 110507695 A CN110507695 A CN 110507695A CN 201910776018 A CN201910776018 A CN 201910776018A CN 110507695 A CN110507695 A CN 110507695A
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Abstract
本发明涉及一种组合物及其制备脑功能恢复药物和/或保健品中的应用。本发明提供了一种组合物，包括：烟酰胺腺嘌呤二核苷酸和/或烟酰胺腺嘌呤单核苷酸、人参、三七、银杏叶、葛根、灯盏花、红景天。本发明提供的技术方案中，三七、人参、银杏叶、葛根、灯盏花、红景天等可以增强NADH和/或NMN对小鼠神经功能的改善，下调脑组织的氧化应激水平，减少脑组织的细胞凋亡。进一步地，经动物实验测定可得，给药后，受试动物脑功能改善较好，记忆力和空间识别能力都有显著提高。
Description
技术领域
本发明属于中药组合物领域，尤其涉及一种含烟酰胺腺嘌呤二核苷酸和/ 或烟酰胺腺嘌呤单核苷酸的组合物及其制备脑功能恢复的药物和/或保健品中的应用。
背景技术
世界范围的人口老龄化增加了脑功能下降的发生，容易引起健忘、焦虑性障碍、欲望的降低、睡眠质量的降低等，严重的甚至会产生记忆障碍及老年性痴呆，这使得受影响的人的生活受到巨大的破坏性影响。但是脑功能减低的成因极其复杂，目前大部分研究仅针对具体脑损伤性疾病，所研究的药物对人体损害较大，副作用较多，并且对于因衰老或身体其他原因引起的脑功能下降的日常预防、改善和治疗的药品和饮食品，基本没有。
发明内容
有鉴于此，本发明提供了一种含烟酰胺腺嘌呤二核苷酸(NADH)和/或烟酰胺腺嘌呤单核苷酸(NMN)的组合物及其在制备脑功能恢复的药物和/或保健品中的应用，用于改善大脑健康及大脑功能，包括但不限于认知、记忆、智力、动机、注意力、专注力、学习能力和更好的沟通及减轻与认知和记忆障碍相关的疾病及类似疾病。
本发明提供了一种含NADH/NMN的组合物及其在制备脑功能恢复的药物和/或保健品中的应用，用于预防、控制及治疗与大脑疾病/障碍，其包括但不限于老年性痴呆、多发梗塞性痴呆症、阅读障碍、失语症、器质性脑综合征、重症肌无力、血管性痴呆、轻度认知功能障碍(MCI)、路易体痴呆症、韦尼克- 科尔萨科夫综合征、阿尔茨海默氏症、帕金森氏症、注意缺陷多动障碍(ADHD)、低氧、缺氧、脑血管功能不全、癫痫、肌阵挛和低胆碱能神经功能障碍，减缓记忆力衰退、功能丧失和治疗记忆障碍疾病、神经退行性疾病，并在大脑中控制血压和血液循环。
本发明提供了一种组合物，所述组合物的原料包括：NADH和/或NMN、人参、红景天、三七、银杏叶、葛根以及灯盏花。
优选地，所述组合物的原料包括：NADH和/或NMN、人参提取物、红景天提取物、三七提取物、银杏叶提取物、葛根提取物以及灯盏花提取物。
优选地，以质量份计，所述组合物的原料包括：NADH和/或NMN 1～10 份、人参1～10份、三七1～10份、红景天1～10份、银杏叶1～10份、葛根1～10 份以及灯盏花1～10份。
优选地，以质量份计，所述组合物的原料包括：NADH和/或NMN 5～9份、人参5～10份、三七3～7份、红景天1～2份、银杏叶4～8份、葛根1～5份以及灯盏花1～4份。
优选地，以质量份计，所述组合物的原料包括：NADH和/或NMN 6～8份、人参6～9份、三七4～6份、红景天1～2份、银杏叶5～8份、葛根2～4份以及灯盏花1～3份。
优选地，以质量份计，所述组合物的原料包括：NADH和/或NMN 7份、人参7份、三七5份、红景天1份、银杏叶7份、葛根3份以及灯盏花2份。
优选地，所述NADH:NMN的质量比例为10:1～1:10。
本发明还提供上述组合物的制备方法，包括如下步骤：
将配比量的三七、人参、银杏叶、葛根、灯盏花、红景天为原料，加8-12 倍量的质量浓度为30-50％的乙醇水溶液浸渍20-25小时后，回流提取3次，合并提取液，离心，滤液真空60-70℃回收乙醇，50-60℃浓缩得到提取液I；
将提取液I中，加入配比量的烟酰胺腺嘌呤二核苷酸和/或烟酰胺腺嘌呤单核苷酸，在室温下充分搅拌混匀，升温至50-70℃真空浓缩后，得到组合物。
本发明还提供了一种包括以上任意一项所述的组合物的制剂，包括：
所述组合物加入常规辅料，按照常规工艺，制成口服制剂和肠道外给药制剂。所述常规辅料包括常规药用辅料或常规食品用辅料。
优选地，所述制剂中不含有乳糖。
优选地，常规药用辅料包括但不限于：
所述药学上或食品上可接受的赋形剂、辅料、载体及稀释剂包括但不限于葡萄糖、果糖、蔗糖、麦芽糖、黄糊精、白糊精、二氧化硅、微晶纤维素粉末、硬脂酸钙、硬脂酸镁、山梨糖醇、甜菊苷、玉米糖浆、柠檬酸、酒石酸、苹果酸、琥珀酸、乳酸、L-抗坏血酸、dl-α-生育酚、甘油、丙二醇、甘油脂肪酸酯、聚甘油脂肪酸酯、蔗糖脂肪酸酯、山梨醇酐脂肪酸酯、丙二醇脂肪酸酯、阿拉伯胶、卡拉胶、酪蛋白、明胶、果胶、琼脂、烟酰胺、泛酸钙、钙盐、色素、香精、防腐剂、蒸馏水、盐水、含水葡萄糖溶液、乙醇、丙二醇和聚乙二醇、各种动物油和植物油、白软石蜡、石蜡和蜡。
本发明还提供了一种包括以上任意一项所述的组合物在制备脑功能恢复的药物和/或保健品中的应用。
综上所述，本发明提供了一种组合物，所述组合物的原料包括：NADH和 /或NMN、人参、三七、银杏叶、葛根、灯盏花、红景天。本发明还提供了一 种上述组合物在制备脑功能恢复的药物和/或保健品中的应用。本发明提供的技 术方案中，三七、人参、银杏叶、葛根、灯盏花、红景天等可以增强NADH和 /或NMN对小鼠神经功能的改善，下调脑组织的氧化应激水平，减少脑组织的 细胞凋亡。进一步地，经动物实验测定可得，给药后，受试动物脑功能改善较 好，记忆力和空间识别能力都有显著提高。
具体实施方式
本发明实施例提供了一种组合物及其在制备脑功能恢复的药物和/或保健品中的应用，用于解决现有技术中，脑功能恢复药物和/或保健品存在着治疗效果差以及对人体存在不良反应的技术缺陷。
下面将对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
为了更详细说明本发明，下面结合实施例对本发明提供的一种组合物及其在制备脑功能恢复的药物和/或保健品中的应用，进行具体地描述。
实施例1
本实施例为制备产品1的具体实施例。
取5g人参、1g红景天、3g三七、4g银杏叶、1g葛根以及1g灯盏花混合，经粉碎、膨化处理后备用；加8倍量的质量浓度为30％的乙醇水溶液浸渍10小时后，回流提取3次，合并提取液，离心，滤液真空60-70℃回收乙醇，50℃真空浓缩得到提取液I。
将提取液I中，加入5g的NADH，在室温下充分搅拌混匀后升温至50℃真空浓缩后，得到组合物。将组合物按常规方法与药用辅料制成片剂。
实施例2
本实施例为制备产品2的具体实施例。
取10g人参、2g红景天、7g三七、8g银杏叶、5g葛根以及4g灯盏花混合，经粉碎、膨化处理后备用；加12倍量的质量浓度为40％的乙醇水溶液15小时后，回流提取3次，合并提取液，离心，滤液真空60-70℃回收乙醇，60℃真空浓缩得到提取液I。
将提取液I中，加入9g的NADH，在室温下充分搅拌混匀后升温至50℃真空浓缩后，得到组合物。将组合物按常规方法与食品用辅料制成胶囊剂。
实施例3
本实施例为制备产品3的具体实施例。
取6g人参、1g红景天、4g三七、5g银杏叶、2g葛根以及1g灯盏花混合，经粉碎、膨化处理后备用；加9倍量的质量浓度为35％的乙醇水溶液浸渍12小时后，回流提取3次，合并提取液，离心，滤液真空60-70℃回收乙醇，真空浓缩得到提取液I。
将提取液I中，加入6g的NMN，在室温下充分搅拌混匀后升温至50℃真空浓缩后，得到组合物。将组合物按常规方法与药用辅料制成粉针剂。
实施例4
本实施例为制备产品4的具体实施例。
取9g人参、2g红景天、6g三七、8g银杏叶、4g葛根以及3g灯盏花混合，经粉碎、膨化处理后备用；加10倍量的质量浓度为45％的乙醇水溶液浸渍12小时后，回流提取3次，合并提取液，离心，滤液真空60-70℃回收乙醇，50℃真空浓缩得到提取液I。
将提取液I中，加入8g的NMN，在室温下充分搅拌混匀后升温至50℃真空浓缩后，得到组合物。将组合物按常规方法与食品用辅料制成丸剂。
实施例5
本实施例为制备产品5的具体实施例。
取7g人参、1g红景天、5g三七、7g银杏叶、3g葛根以及2g灯盏花混合，经粉碎、膨化处理后备用；加12倍量的质量浓度为50％的乙醇水溶液浸渍12小时后，回流提取3次，合并提取液，离心，滤液真空60-70℃回收乙醇，50℃真空浓缩得到提取液I。
将提取液I中，加入7g的NAD和NMN的混合物(1:1)，在室温下充分搅拌混匀后升温至50℃真空浓缩后，得到组合物。将组合物按常规方法与药用辅料制成吸入剂。
实验例1
将实施例1(NADH)、实施例3(NMN)和实施例5(NADH/NMN 1:1) 制备的产品混合到小鼠饵料中，给予6周龄的SAMP 8小鼠。各产品的加入量为 10mg/kg/day。可自由摄取水。饵料3天交换一次，持续给予3个月。之后进行步入(step through)型被动逃避试验。本试验是利用了小鼠喜欢黑暗的习性的记忆学习能力的一个试验方法。是从明室转移到暗室时通过电刺激让其记忆并在24 小时后以明室停留时间的长短来评价“记住多少暗室危险”的方法。即，明室停留时间的长短表示记忆学习能力的高低。分析使用软件ShutAvoid(PanLab公司)。
第一天的预备学习中，将进入暗室前的时间(潜伏期)设为最大2分钟，1分钟的明室驯化后打开遮蔽门，转移到暗室后关上门，给予2秒钟0.4mA的电刺激。电刺激后迅速将小鼠放回笼子。第二天的正式试验中，将潜伏期最大设为5分钟，测定在明室停留的时间。将第二天在明室持续停留5分钟的个体的潜伏期设为5 分钟进行计算。
第二天的明室停留时间按组取平均，以对照组(无摄取组)为1.0，计算其比率。每组的个体数如下：对照组24只、NADH组(实施例1产品)8只、NMN组(实施例3产品)8只、NADH/NMN组(实施例5产品)8只。对照组和各产品组的结果如表1所示。
表1被动逃避试验结果
| 样品 | 个体数 | SAMP8被动逃避试验(与对照组的比) |
| 对照组(正常饵料) | 24 | 1.0 |
| NADH组 | 8 | 1.2 |
| NMN组 | 8 | 1.1 |
| NADH/NMN组 | 8 | 1.4 |
从表1可知，各产品组与对照组相比，具有高的被动逃避效果。其中，NADH/NMN组中可观察到比对照组1.4倍的被动逃避效果。此外，NADH组的被动逃避效果的对照比为1.2比单独的NMN组要好。该结果表明本发明的产品具有脑功能改善效果。
实验例2
采用高架放射臂迷宫方法测试小鼠对改善学习及记忆的功效：动物研究方案已得到机构动物伦理委员会的批准。将6周龄的小鼠适应环境一周并选择健康小鼠进行研究。将选择的小鼠在高架放射臂迷宫(RAM)中预先训练，将适应的小鼠分配于不同的处理组，每组包含8只小鼠。完成预训练后，对动物每天进行如实验例1相同的处理持续并持续至两周。在处理期间，小鼠置于RAM上，每次10分钟以认识存在于三个不同颜色臂上的食物丸。在训练过程中，通过计算不同的参数如需要学习任务的天数、发现食物的潜伏期、错误进入/尝试的次数来测试空间学习能力。在这样处理后，给予所训练的小鼠一个星期(第三周) 的休息而不需要处理或训练。在第四周，对小鼠采用相同的同屋通过测试潜伏期及错误进入的数量来进行记忆保持测试。通过ANOVA及适当的事后比较来分析数据。结果如表2所示：
表2高架放射臂迷宫实验结果
| 学习天数 | 潜伏期(S) | 错误进入数 | |
| 对照组(正常饵料) | 10±0.6 | 483±0.84 | 10±0.4 |
| NADH组 | 2±0.3 | 356±0.16 | 5±0.6 |
| NMN组 | 2±0.5 | 408±0.59 | 5±0.8 |
| NADH/NMN组 | 1±0.1 | 319±0.54 | 3±0.5 |
如表2所示，各产品组显著(P<0.01)地减少了在所设置条件下小鼠需要学习的天数，并且显著地(P<0.05)降低了学习后的小鼠在高架RAM模型中找到食物所需要的时间。与对照组相比，各产品组显示出了显著的空间学习能力的提高，以减少潜伏期及错误进入的数量为代表。其中尤以NADH/NMN组效果最为显著。这些结果都证实本发明产品能够提高了空间学习及记忆保持。
从上述实施例可以得出，本发明提供的技术方案，具有以下优点：
1、人参可通过调节Bax、Bcl-2蛋白表达来减少脑细胞凋亡，其作用机制与上调NAIP和Bcl-2蛋白表达和降低Bax蛋白表达有关。
三七可抑制脑血管内皮细胞凋亡，上调VEGF表达，促进血管再生。同时还可上调胶质纤维酸性蛋白(glial fibrillary acidic protein，GFAP)、碱性成纤维细胞生长因子(Basic fibroblastgrowth factor，BFGF)的表达，改善脑自体神经干细胞(neural stemcells，NSCs)的生存微环境，促进脑自体神经干细胞的增殖，进而改善小鼠的脑神经功能。
银杏叶可显著减少小鼠脑组织细胞凋亡，抑制脑组织c-fos蛋白表达，促进脑神经修复。
葛根能显著降低神经功能缺损评分，明显减少脑坏死体积与凋亡阳性细胞数，其神经保护作用机制与抑制STAT3的磷酸化水平、降低P53的表达及JAK2 /STAT3信号通路异常激活有关。
灯盏花对新生小鼠脑组织神经细胞凋亡均具有明显的抑制作用，其机制与调节Bax/Bcl-2基因表达、下调caspase-3、NF-kB及Fas蛋白表达等有关。
红景天能够改善MCAO小鼠的脑神经功能损伤，抑制神经细胞凋亡，主要是通过激活PI3K/AKT信号通路，促进AKT的磷酸化，激活NRF2的核转录，促进HO-1的蛋白表达，进而抑制神经细胞凋亡，改善神经功能。
因此，本发明中的三七、人参、银杏叶、葛根、灯盏花、红景天等可以增强NADH和/或NMN对脑神经功能的改善，下调脑组织的氧化应激水平，减少脑组织的细胞凋亡。
2、本发明以人参、银杏叶为君，安神益智，活血通络，以三七、葛根为臣，通络舒筋，兼养阴生津。以灯盏花、红景天为佐使，活血舒筋，散淤消肿。三者相伍，具有活血通络，益气生津的功效，能明显改善脑神经功能，减少脑细胞凋亡，从而促进脑功能恢复。
3、本发明采用特定的成分特定的配比，组方合理，配伍得当，本发明所选成分配伍相宜，符合中医药和现代医药相结合的理论，使用方便，吸收效果好，无不良及毒副作用，经临床验证，能有效的提高和改善脑功能，促进脑功能的恢复。
综上所述，本发明提供了一种组合物，所述组合物的原料包括：NADH和 /或NMN、人参、三七、银杏叶、葛根、灯盏花、红景天。本发明还提供了一种上述组合物在制备脑功能恢复的药物和/或保健品中的应用。本发明提供的技术方案中，三七、人参、银杏叶、葛根、灯盏花、红景天等可以增强NADH和 /或NMN对小鼠神经功能的改善，下调脑组织的氧化应激水平，减少脑组织的细胞凋亡。进一步地，经动物实验测定可得，给药后，受试动物脑功能改善较好，记忆力和空间识别能力都有显著提高。
以上所述仅是本发明的优选实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本发明原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也应视为本发明的保护范围。
Claims (10)
1.一种组合物，其特征在于，所述组合物的原料包括：烟酰胺腺嘌呤二核苷酸和/或烟酰胺腺嘌呤单核苷酸、人参、三七、银杏叶、葛根、灯盏花、红景天。
2.根据权利要求1所述的组合物，其特征在于，所述组合物的原料包括：烟酰胺腺嘌呤二核苷酸和/或烟酰胺腺嘌呤单核苷酸、人参提取物、三七提取物、银杏叶提取物、葛根提取物、灯盏花提取物以及红景天提取物。
3.根据权利要求2所述的组合物，其特征在于，以质量份计，所述组合物的原料包括：烟酰胺腺嘌呤二核苷酸和/或烟酰胺腺嘌呤单核苷酸1～10份、人参1～10份、三七1～10份、红景天1～10份、银杏叶1～10份、葛根1～10份以及灯盏花1～10份。
4.根据权利要求3所述的组合物，其特征在于，以质量份计，所述组合物的原料包括：烟酰胺腺嘌呤二核苷酸和/或烟酰胺腺嘌呤单核苷酸5-9份、人参5～10份、三七3～7份、红景天1～2份、银杏叶4～8份、葛根1～5份以及灯盏花1～4份。
5.根据权利要求4所述的组合物，其特征在于，以质量份计，所述组合物的原料包括：烟酰胺腺嘌呤二核苷酸和/或烟酰胺腺嘌呤单核苷酸6～8份、人参6～9份、三七4～6份、红景天1～2份、银杏叶5～8份、葛根2～4份以及灯盏花1～3份。
6.根据权利要求1所述的组合物，其特征在于，所述NADH:NMN的质量比例为10:1～1:10。
7.一种权利要求1-6任一项所述的组合物的制备方法，其特征在于，包括如下步骤:
将配比量的三七、人参、银杏叶、葛根、灯盏花、红景天为原料，加8-12倍量的质量浓度为30-50％的乙醇水溶液浸渍20-25小时后，回流提取3次，合并提取液，离心，滤液真空60-70℃回收乙醇，50-60℃浓缩得到提取液I；
将提取液I中，加入配比量的烟酰胺腺嘌呤二核苷酸和/或烟酰胺腺嘌呤单核苷酸，在室温下充分搅拌混匀，升温至50-70℃真空浓缩后，得到组合物。
8.包括权利要求1-6任一项所述的组合物的制剂，其特征在于，
所述组合物加入常规辅料，按照常规工艺，制成口服制剂和肠道外给药制剂，所述常规辅料包括常规药用辅料或常规食品用辅料。
9.根据权利要求8所述的制剂，其特征在于，所述制剂中不含有乳糖。
10.权利要求1-6任一项所述的组合物在制备脑功能恢复的药物和/或保健品中的应用。
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| WO2021031536A1 (zh) * | 2019-08-20 | 2021-02-25 | 泓博元生命科技（深圳）有限公司 | Nadh 和 / 或 nmn 在制备脑功能恢复的药物、保健品中的应用 |
| CN114288353A (zh) * | 2022-01-19 | 2022-04-08 | 宝莱福健康科技研究(中山)有限公司 | 一种防治阿尔茨海默症的组合物制备方法及其应用 |
| CN116098918A (zh) * | 2022-11-11 | 2023-05-12 | 中国药科大学 | 一种胞磷胆碱药物组合物及其用途 |
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| CN111759877A (zh) * | 2020-07-02 | 2020-10-13 | 深圳市旷逸生物科技有限公司 | 含nmn的益智健脑药物组合物 |
| CN114288353A (zh) * | 2022-01-19 | 2022-04-08 | 宝莱福健康科技研究(中山)有限公司 | 一种防治阿尔茨海默症的组合物制备方法及其应用 |
| CN116098918A (zh) * | 2022-11-11 | 2023-05-12 | 中国药科大学 | 一种胞磷胆碱药物组合物及其用途 |
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