CN114557446A - 二氢杨梅素作为活性成分在睡眠障碍中的应用 - Google Patents
二氢杨梅素作为活性成分在睡眠障碍中的应用 Download PDFInfo
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- CN114557446A CN114557446A CN202210257965.3A CN202210257965A CN114557446A CN 114557446 A CN114557446 A CN 114557446A CN 202210257965 A CN202210257965 A CN 202210257965A CN 114557446 A CN114557446 A CN 114557446A
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- dihydromyricetin
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
本发明属于医药技术领域，具体涉及二氢杨梅素作为活性成分在睡眠障碍中的应用。本发明以二氢杨梅素为原料制备的药物，可以增加大脑ATP供应，增加Gephyrin蛋白水平，改善大脑抑制性神经元(GAMA氨基丁酸)的功能；通过该化合物，可以有效改善痴呆患者夜间睡眠障碍，尤其是伴有夜间躁动兴奋状态，同时可以调节多巴胺神经元功能，通过调节抑制性神经元功能起到镇静作用，减轻焦虑抑郁和失眠现象，安全性好，没有依赖性和耐受性及其他的不良反应。
Description
技术领域
本发明属于医药技术领域，具体涉及二氢杨梅素作为活性成分在睡眠障碍中的应用。
背景技术
老年痴呆、卒中后痴呆、帕金森痴呆等多种痴呆症中70％伴有睡眠障碍，睡眠障碍的常见表现为夜间躁动、过度兴奋、日落激越等。痴呆患者大脑中抑制性神经元与兴奋性神经元失衡，睡眠觉醒节律被破坏。失眠亦为睡眠障碍，失眠伴随着焦虑/抑郁为现代生活中常见的心身疾病。失眠患者睡眠-觉醒节律紊乱，大脑抑制性神经元(GAMA氨基丁酸能神经元)功能失调。失眠患者伴随的焦虑/抑郁多与大脑多巴胺分泌失调有关。目前市场上现有的用于治疗痴呆伴睡眠障碍或者失眠伴随焦虑/抑郁等症状是通过使用抗精神分裂药物或者抗失眠、抗焦虑抑郁药物等。然而，抗精神分裂药物会引起明显的认知损害、大脑高级神经功能损害和运动功能损害；此外，抗失眠抗焦虑抑郁药物常有显著不良反应如嗜睡、疲乏、肢体运动不协调、记忆力差、性功能障碍等，且具有依赖性和耐受性。
二氢杨梅素的化学名(2R,3R)-3,5,7-三羟基-2-(3,4,5-三羟基苯基)苯并二氢吡喃-4-酮，作为一种黄酮儿茶酚化合物(图1)，除具有黄酮类化合物的一般特性外，还具有解除醇中毒、预防酒精肝、脂肪肝、抑制肝细胞恶化、减轻炎症等作用，具有巨大的药用价值。二氢杨梅素是茅岩莓等葡萄科蛇葡萄属植物中的主要化学成分，其在茅岩莓春夏幼嫩茎叶中二氢杨梅素的含量达到样品干重的20％以上，幼叶中的心叶可达40％以上。此外，二氢杨梅素及含有二氢杨梅素的植物提取物不仅具有降血糖，降血脂，抗氧化等多种功效，同时还表现出了高安全性，并被作为食品添加剂在我国广泛使用。
发明内容
针对上述现有技术的不足，本发明提供了二氢杨梅素作为活性成分在睡眠障碍中的应用，目的是为了解决针对痴呆症伴随睡眠障碍以及失眠伴焦虑/抑郁，采取抗精神分裂药物或者抗失眠、抗焦虑抑郁药物等应对措施，造成使用者嗜睡、疲乏、肢体运动不协调、记忆力差、性功能障碍等不良反应，具有依赖性和耐受性，安全性不够高的技术问题。
本发明提供的二氢杨梅素作为活性成分在睡眠障碍中的应用，包括如下两个技术方案：
方案一
二氢杨梅素作为活性成分在睡眠障碍中的应用，将二氢杨梅素用于制备治疗痴呆伴睡眠障碍的食物或者药物，所述二氢杨梅素是指二氢杨梅素单体和/或含二氢杨梅素的植物。
在某些实施方式中，利用含二氢杨梅素的植物制备为食品组合物，所述食品组合物按质量百分数计包括茅岩莓10-80％、磷酯酰丝氨酸5-30％、枳椇子10-50％、酸枣仁1-30％和水苏糖1-30％。
进一步，所述食品组合物还包括苦荞麦苗1-10％、杨梅0.5-5％、桂圆0.5-5％。
在某些实施方式中，所述治疗痴呆伴睡眠障碍的食物或者药物的制剂剂型为口服液、固体饮料、颗粒剂、胶囊剂、片剂、泡腾片、糖浆剂、丸剂、膏滋剂、软胶囊、软膏剂、乳剂、散剂、缓释剂、控释剂、靶向制剂、粉针剂、水针剂、注射剂、雾化剂、微乳剂、凝胶剂、纳米制剂。
方案二
二氢杨梅素作为活性成分在睡眠障碍中的应用，将二氢杨梅素用于制备治疗失眠伴焦虑/抑郁的食物或者药物，所述二氢杨梅素是指二氢杨梅素单体和/或含二氢杨梅素的植物。
在某些实施方式中，利用含二氢杨梅素的植物制备为食品组合物，所述食品组合物按质量百分数计包括茅岩莓10-80％、磷酯酰丝氨酸5-30％、枳椇子10-50％、酸枣仁1-30％、水苏糖1-30％、香蕉1-10％、燕麦1-5％和葵花籽1-5％。
在某些实施方式中，所述治疗失眠伴焦虑/抑郁的食物或者药物的制剂剂型为口服液、固体饮料、颗粒剂、胶囊剂、片剂、泡腾片、糖浆剂、丸剂、膏滋剂、软胶囊、软膏剂、乳剂、散剂、缓释剂、控释剂、靶向制剂、粉针剂、水针剂、注射剂、雾化剂、微乳剂、凝胶剂、纳米制剂。
本发明具有以下有益效果：本发明以二氢杨梅素为原料制备的药物，可以增加大脑ATP供应，增加Gephyrin蛋白水平，改善大脑抑制性神经元(即调控γ-氨基丁酸)的功能；通过该化合物，可以有效改善痴呆患者夜间睡眠障碍，尤其是伴有夜间躁动兴奋状态，同时可以调节多巴胺神经元功能，通过调节抑制性神经元功能起到镇静作用，减轻焦虑抑郁和失眠现象，安全性好，没有依赖性和耐受性及其他的不良反应。
附图说明
图1是本发明二氢杨梅素的分子结构式；
图2是本发明实施例1中二氢杨梅的提取工艺流程图；
图3是本发明实施例1中DHM对AD模型小鼠大脑中Gephyrin蛋白的水平影响对比图；
图4是本发明实施例1中DHM对AD模型动物认知能力的影响对比图；
图5是本发明实施例2中服用前和服用后的睡眠时间对比图；
图6是本发明实施例3中服用前和服用后的躁动次数对比图；
图7是本发明实施例4中服用前和服用后的睡眠时间对比图；
图8是本发明实施例7中DHM对AD模型小鼠ATP的水平影响对比图；
图9是本发明实施例7中DHM对AD模型小鼠大脑中Gephyrin蛋白的水平影响对比图；
图10是本发明实施例8中服用前和服用后的睡眠时间对比图；
图11是本发明实施例9中高教迷宫实验和小鼠活跃探索行为评价小鼠焦虑抑郁状态对比图。
具体实施方式
为使本发明的目的、技术方案和优点更加清楚明白，以下结合具体实施例，并参照附图，对本发明进一步详细说明。
实施例1
本实施例中的二氢杨梅素是从茅岩莓(藤茶)中提取获得的二氢杨梅素。提取方法如图2所示，分别通过过滤干燥获得50％的二氢杨梅素，通过重结晶的方式获得98％的二氢杨梅素。利用上述方法提取的DHM进行动物实验。
选取16只20月龄转基因AD模型小鼠(TG-SwDI)和8只同样月龄非转基因小鼠(野生型Wt)作为对照，共分为3组：对照组、AD模型组、AD治疗组(DHM 2mg/kg/day)，口服(混于饲料中)，连续使用3月。在1.5月及3月时检测各组大脑Gephyrin蛋白水平，以及观察DHM对AD模型动物认知能力的影响，采用新客观物体识别率(ORI)和新内容识别率(RI)作为评价指标。如图3所示，二氢杨梅素(DHM)增加老年痴呆(AD)大脑中Gephyrin蛋白的水平。如图4所示，DHM有效提高了AD模型动物的认知能力。
实施例2
选取30个睡眠障碍患志愿者(包括早醒、难以入睡、片段睡眠等)，年龄30-70岁，男女均有，使用本实施例提供的将以二氢杨梅素作为活性成分之一制作的药物，本实施例中提供的药物为固体饮料制剂(固体粉末)，使用方法为温水冲服。每次服用DHM 100mg，每日1-2次，持续使用4周，观察睡眠时间情况。对服用本实施例前的睡眠时间进行统计，服用后的睡眠时间也进行统计。如图5所示，服用本实施例提供的药物后，志愿者的睡眠时间大幅度延长，有效优化了睡眠质量。
实施例3
本实施例利用含有二氢杨梅素的植物制备治疗痴呆伴睡眠障碍的食品组合物。
食品组合物，按质量百分数计包括如下组分：茅岩莓10％，枳椇子10％，磷脂酰丝氨酸30％，水苏糖10％，酸枣仁10％，苦荞麦苗5％，桂圆5％，杨梅5％，抗性糊精15％。将本实施例提供的药食同源的食品组合物用于作为治疗制备治疗痴呆伴睡眠障碍的食物。本实施例中提供的药食同源的食品组合物的剂型为固体饮料制剂(固体粉末)，使用方法为温水冲服。
选取10名痴呆伴夜间躁动患者(包括老年痴呆和血管性痴呆)，年龄60-80岁，男女均有，使用本实施例提供的药食同源的食品组合物，每次1袋(每袋重量3g)，每日1-2次持续使用4周，观察每周夜间躁动次数。如图6所示，本实施例提供的药食同源的食品组合物制备的食物，使每周夜间躁动次数由每周6次减至每周2次，有效缓解了夜间躁动的症状。
实施例4
本实施例利用含有二氢杨梅素的植物制备治疗痴呆伴睡眠障碍的食品组合物。
食品组合物，按质量百分数计包括如下组分：茅岩莓10％，枳椇子10％，磷脂酰丝氨酸30％，水苏糖10％、酸枣仁10％、苦荞麦苗5％、桂圆5％、杨梅5％、抗性糊精15％。将本实施例提供的药食同源的食品组合物用于作为治疗制备治疗痴呆伴睡眠障碍的食物。本实施例中提供的食品组合物的剂型为固体饮料制剂(固体粉末)，使用方法为温水冲服。
10个痴呆伴睡眠障碍患志愿者(包括夜间躁动、片段睡眠、日落激越等)，年龄60-80岁，男女均有，本实施例提供的药食同源的食品组合物，每次1袋(3g)，每日1-2次，持续使用4周，观察睡眠时间情况。对服用本实施例前的睡眠时间进行统计，服用后的睡眠时间也进行统计。如图7所示，服用本实施例提供的食品组合物制备的食物后，志愿者的睡眠时间大幅度延长，有效优化了睡眠质量。
实施例5
本实施例利用含有二氢杨梅素的植物制备治疗痴呆伴睡眠障碍的食品组合物。
食品组合物，按质量百分数计包括如下组分：茅岩莓10％和磷酯酰丝氨酸30％、枳椇子39％、酸枣仁1％、水苏糖9％、苦荞麦苗10％、杨梅0.5％和桂圆0.5％。
实施例6
本实施例利用含有二氢杨梅素的植物制备治疗痴呆伴睡眠障碍的食品组合物。
食品组合物，按质量百分数计包括如下组分：茅岩莓70％和磷酯酰丝氨酸5％、枳椇子10％、酸枣仁4％、水苏糖1％、苦荞麦苗5％、杨梅2％和桂圆3％。
实施例7
本实施例利用含有二氢杨梅素的植物制备治疗失眠伴焦虑/抑郁的食品组合物。
食品组合物，按质量百分数计包括如下组分：茅岩莓50％、磷酯酰丝氨酸5％、枳椇子10％、酸枣仁10％、水苏糖10％、葵花籽5％、香蕉5％、燕麦5％。选取36只雄性8周小鼠分为6组，采用社会分离法制造焦虑抑郁动物模型，6组分别为1组(G2+Veh2)：群组饲养2周+蔗糖作为空白对照饲养2周；2组(G2+D2)：群组饲养两周+本实施例食物组合物饲养2周20mg/kg/day；3组(Iso2+Veh2)：分离饲养2周+蔗糖作为空白对照饲养2周；4组(Iso2+D2)：分离饲养2周+本实施例食物组合物饲养2周(20mg/kg/day)；5组(Iso4+D2)：分离饲养4周+本实施例食物组合物饲养2周(20mg/kg/day)；6组(Iso4+DZ2)：分离饲养4周+地西泮饲养2周(10mg/kg/day)。各组周期结束后分别观察各组大脑ATP及Gephyrin蛋白水平。如图8-9所示，本实施例的食品组合物增加了大脑ATP供应和Gephyrin蛋白水平。
实施例8
本实施例利用含有二氢杨梅素的植物制备治疗失眠伴焦虑/抑郁的食品组合物。
食品组合物，按质量百分数计包括如下组分：茅岩莓50％、磷酯酰丝氨酸5％、枳椇子10％、酸枣仁10％和水苏糖10％，葵花籽5％、香蕉5％、燕麦5％。本实施利用上述组合物作为治疗失眠伴焦虑/抑郁的食物。本实施例提供的药食同源的食品组合物为固体饮料制剂(固体粉末)，使用方法为温水冲服。
20名失眠伴焦虑抑郁患者，年龄15-60岁，男女均有，使用本实施例提供的药食同源的食品组合物，每次1袋(2g)，每日1-2次，持续使用4周，观察睡眠改善情况。如图10所示，服用本实施例提供的食品组合物制备的食物后，志愿者的睡眠时间大幅度延长，有效优化了睡眠质量。
实施例9
本实施例利用含有二氢杨梅素的植物制备治疗失眠伴焦虑/抑郁的食品组合物。
食品组合物，按质量百分数计包括如下组分：茅岩莓50％、磷酯酰丝氨酸5％、枳椇子10％、酸枣仁10％、水苏糖10％、葵花籽5％、香蕉5％、燕麦5％。本实施利用上述组合物作为治疗失眠伴焦虑/抑郁的药物，在动物模型上进行应用。
选取36只雄性8周小鼠分为6组，采用社会分离法制造焦虑抑郁动物模型，6组分别为1组(G2+Veh2)：群组饲养2周+蔗糖作为空白对照饲养2周；2组(G2+D2)：群组饲养两周+本实施例食物组合物饲养2周20mg/kg/day；3组(Iso2+Veh2)：分离饲养2周+蔗糖作为空白对照饲养2周；4组(Iso2+D2)：分离饲养2周+本实施例食物组合物饲养2周(20mg/kg/day)；5组(Iso4+D2)：分离饲养4周+本实施例食物组合物饲养2周(20mg/kg/day)；6组(Iso4+DZ2)：分离饲养4周+地西泮饲养2周(10mg/kg/day)。采用高教迷宫实验和小鼠活跃探索行为评价小鼠焦虑抑郁状态。高架迷宫实验：小鼠停留在开放臂、封闭臂和交叉区域的时间。小鼠停留在开放臂时间越长，焦虑程度越低。
如图11所示，本实施例提供的食品组合物制备的药物改善小鼠焦虑样行为，显著增加分离焦虑模型小鼠在开放臂停留时间。本品对于分离焦虑模型的小鼠运动活跃、探索行为有积极影响。应用启动时间、竖尾时间、中央时间、路径长度、闭臂后腿直立时间和角落时间来评价。本实施例提供的药物显著改善以上指标，减轻分离焦虑模型小鼠的行为异常。
实施例10
本实施例利用含有二氢杨梅素的植物制备治疗失眠伴焦虑/抑郁的食品组合物。
食品组合物，按质量百分数计包括如下组分：茅岩莓10％、磷酯酰丝氨酸30％、枳椇子38％、酸枣仁1％、水苏糖9％、香蕉10％、燕麦1％、葵花籽1％。
实施例11
本实施例利用含有二氢杨梅素的植物制备治疗失眠伴焦虑/抑郁的食品组合物。
食品组合物，按质量百分数计包括如下组分：茅岩莓15％和磷酯酰丝氨酸10％、枳椇子15％、酸枣仁25％、水苏糖26％、香蕉1％、燕麦4％、葵花籽4％。
上述仅本发明较佳可行实施例，并非是对本发明的限制，本发明也并不限于上述举例，本技术领域的技术人员，在本发明的实质范围内，所作出的变化、改型、添加或替换，也应属于本发明的保护范围。
Claims (8)
1.二氢杨梅素作为活性成分在睡眠障碍中的应用。
2.根据权利要求1所述的应用，其特征在于，将二氢杨梅素用于制备治疗痴呆伴睡眠障碍的食物或者药物，所述二氢杨梅素是指二氢杨梅素单体和/或含二氢杨梅素的植物。
3.根据权利要求2所述的应用，其特征在于，利用含二氢杨梅素的植物制备为食品组合物，所述食品组合物按质量百分数计包括茅岩莓10-80％、磷酯酰丝氨酸5-30％、枳椇子10-50％、酸枣仁1-30％和水苏糖1-30％。
4.根据权利要求3所述的应用，其特征在于，所述食品组合物还包括苦荞麦苗1-10％、杨梅0.5-5％、桂圆0.5-5％。
5.根据权利要求2所述的应用，其特征在于，所述治疗痴呆伴睡眠障碍的食物或者药物的制剂剂型为口服液、固体饮料、颗粒剂、胶囊剂、片剂、泡腾片、糖浆剂、丸剂、膏滋剂、软胶囊、软膏剂、乳剂、散剂、缓释剂、控释剂、靶向制剂、粉针剂、水针剂、注射剂、雾化剂、微乳剂、凝胶剂、纳米制剂。
6.根据权利要求1所述的应用，其特征在于，将二氢杨梅素用于制备治疗失眠伴焦虑/抑郁的食物或者药物，所述二氢杨梅素是指二氢杨梅素单体和/或含二氢杨梅素的植物。
7.根据权利要求6所述的应用，其特征在于，利用含二氢杨梅素的植物制备为食品组合物，所述食品组合物按质量百分数计包括茅岩莓10-80％、磷酯酰丝氨酸5-30％、枳椇子10-50％、酸枣仁1-30％、水苏糖1-30％、香蕉1-10％、燕麦1-5％和葵花籽1-5％。
8.根据权利要求6所述的应用，其特征在于，所述治疗失眠伴焦虑/抑郁的食物或者药物的制剂剂型为口服液、固体饮料、颗粒剂、胶囊剂、片剂、泡腾片、糖浆剂、丸剂、膏滋剂、软胶囊、软膏剂、乳剂、散剂、缓释剂、控释剂、靶向制剂、粉针剂、水针剂、注射剂、雾化剂、微乳剂、凝胶剂、纳米制剂。
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| CN202110869040X | 2021-07-30 | ||
| CN2021108690363 | 2021-07-30 | ||
| CN202110869040.XA CN113558234A (zh) | 2021-07-30 | 2021-07-30 | 天然食品组合物及其应用 |
| CN2021108690344 | 2021-07-30 | ||
| CN202110869034.4A CN113519838A (zh) | 2021-07-30 | 2021-07-30 | 药食同源的食品组合物及其应用 |
| CN202110869036.3A CN113425712A (zh) | 2021-07-30 | 2021-07-30 | 二氢杨梅素在抗痴呆伴睡眠障碍中的应用 |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104721181A (zh) * | 2015-02-14 | 2015-06-24 | 罗观堤 | 二氢杨梅素在制备促进睡眠、改善睡眠质量制剂的用途 |
| CN105685999A (zh) * | 2016-02-26 | 2016-06-22 | 初建忠 | 一种调节人体整体机能的食疗品 |
| CN110063952A (zh) * | 2018-01-22 | 2019-07-30 | 山东冠秀生物科技有限公司 | 二氢杨梅素衍生物在治疗改善睡眠中的用途 |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104721181A (zh) * | 2015-02-14 | 2015-06-24 | 罗观堤 | 二氢杨梅素在制备促进睡眠、改善睡眠质量制剂的用途 |
| CN105685999A (zh) * | 2016-02-26 | 2016-06-22 | 初建忠 | 一种调节人体整体机能的食疗品 |
| CN110063952A (zh) * | 2018-01-22 | 2019-07-30 | 山东冠秀生物科技有限公司 | 二氢杨梅素衍生物在治疗改善睡眠中的用途 |
Non-Patent Citations (1)
| Title |
|---|
| 周海云等: "二氢杨梅素药理及药物相互作用研究进展", 《中草药》, vol. 49, no. 14, pages 3411 - 3418 * |
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