CN110882245A - 一种改善睡眠的组合物及其用途 - Google Patents
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Abstract
本发明公开了一种改善睡眠的组合物及其用途。本发明将虾青素和褪黑素通过一定的配伍组合,在改善睡眠方面可发挥明显的协同作用,具备安全、高效的改善睡眠作用,可用于制备改善睡眠的药物或保健食品。
Description
技术领域
本发明属于药物和保健制品技术领域,具体涉及一种改善睡眠的组合物及其用途。
背景技术
睡眠占据了人类生命1/3左右的时间,它与人的健康和工作能力密切相关,是生命所必需的过程。随着社会的发展、生活节奏的加快,睡眠障碍的发病率呈逐年增长的趋势。据统计,全球约有27%的人遭受睡眠疾病的困扰,仅我国就约有3亿成年人患有不同程度的睡眠疾病。长时间的睡眠紊乱可导致人体免疫功能下降,容易引发高血压、糖尿病、心脑血管疾病及各类肠胃疾病,使人记忆力减退、脑功能减退、性腺功能降低,引起机体衰老,甚至会引发脑萎缩、老年痴呆、帕金森综合症、精神分裂等神经性疾病。睡眠障碍疾病已经成为全球重要社会问题,给患者和社会造成了巨大危害。
失眠是临床上最常见的睡眠障碍性疾病,失眠是指无法入睡或无法保持睡眠状态,导致睡眠不足,又称入睡和维持睡眠障碍,为各种原因引起入睡困难、睡眠深度或频度过短、早醒及睡眠时间不足或质量差等,是一种常见病。失眠往往会给患者带来极大的痛苦和心理负担,又会因为滥用失眠药物而损伤身体其他方方面面。但也有很多方法可以缓解和治疗失眠。失眠虽不属于危重疾病,但妨碍人们正常生活、工作、学习和健康,并能加重或诱发心悸、胸痹、眩晕、头痛、中风病等病症。顽固性的失眠,给病人带来长期的痛苦,甚至形成对安眠药物的依赖,而长期服用安眠药物又可引起医源性疾病。因此,研发毒副作用小、可以有效改善睡眠的药物对于提高国民健康水平和生活质量具有重要的意义。
褪黑素主要是由哺乳动物和人类的松果体产生的一种胺类激素,又称为美拉酮宁、抑黑素、松果体素,是存在于从藻类到人类等众多生物中的一种荷尔蒙。褪黑素的分泌是有昼夜节律的,一般在凌晨2-3点达到高峰。夜间褪黑素水平的高低直接影响到睡眠的质量。随着年龄的增长,特别是35岁以后,体内自身分泌的褪黑素明显下降,平均每10年降低10-15%,导致睡眠紊乱以及一系列功能失调,而褪黑素水平降低、睡眠减少是人类脑衰老的重要标志之一。因此,从体外补充褪黑素,可使体内的褪黑素水平维持在年轻状态,调整和恢复昼夜节律。
虾青素,是从河螯虾外壳、牡蛎和鲑鱼中发现的一种红色类胡萝卜素,化学名称是3,3′-二羟基-4,4′-二酮基β-胡萝卜素,在体内可与蛋白质结合而呈青、蓝色。虾青素是一种非维生素A源的类胡萝卜素,在动物体内不能转变为维生素A,但具有极强的抗氧化性能。虾青素有“超级VE”之称,被认为是目前为止发现的抗氧化能力最强的物质,是天然VE的1000倍。近年来的研究表明,虾青素具有防治心血管疾病、降低血压、防治动脉粥样硬化、保护神经系统、缓解炎症、防治癌症、治疗肝损伤、减轻肥胖、防治糖尿病、保护皮肤、保护视力、减少运动损伤、增强免疫力等多方面的药理活性。国内外大量的研究均已证实虾青素具有超强的抗氧化能力和多种生物学功能,而且安全、无毒副作用,使其在医药产品、功能性食品和保健食品的生产中具有非常广阔应用前景。
发明内容
本发明的目的在于克服现有技术的不足之处,提供了一种改善睡眠的组合物及其用途。该组合物包括虾青素和褪黑素。褪黑素是人体内的一种内源性的具有调节睡眠作用的激素,虾青素是具有调节时差作用的最强的抗氧剂。本发明将以上两种物质通过一定的配伍组合,在改善睡眠方面可发挥明显的协同作用,可将虾青素与褪黑素组合用于制备改善睡眠的药物和保健食品。
本发明解决其技术问题所采用的技术方案之一是:
一种改善睡眠的组合物,包括质量比为0.1~10:1的虾青素和褪黑素。
本发明解决其技术问题所采用的技术方案之二是:
一种改善睡眠的组合物在制备改善睡眠的药物中的用途。
一实施例中:所述改善睡眠通过延长睡眠时间实现。
一实施例中:所述药物的剂型为口服制剂。
一实施例中:所述口服制剂包括软胶囊、硬胶囊、片剂、丸剂、膏剂、丹剂、口服液等。
一实施例中:所述药物由所述组合物按照药学上可接受的工艺直接制成,或由所述组合物与药学上可接受的辅料混合后按照药学上可接受的工艺制成。所述辅料包括稀释剂、溶剂、赋形剂、吸收剂、润湿剂、黏合剂、崩解剂、润滑剂、增溶剂、乳化剂、助悬剂、表面活性剂、成膜剂、抛射剂、抗氧剂、矫味剂、芳香剂、杀菌剂、防腐剂等。
本发明解决其技术问题所采用的技术方案之三是:
一种改善睡眠的组合物在制备改善睡眠的保健食品中的用途。
一实施例中:所述改善睡眠通过延长睡眠时间实现。
本发明解决其技术问题所采用的技术方案之四是:
一种上述的组合物在制备免疫损伤的保护剂中的用途。
本发明同时提供了虾青素在制备免疫损伤的保护剂中的用途。
一实施例中:所述免疫损伤由睡眠剥夺导致。
一实施例中:所述免疫损伤的保护剂的作用通过增加廓清指数、吞噬指数或脏器系数实现。
本技术方案与背景技术相比,它具有如下优点:
本发明提供了由虾青素和褪黑素按照一定配比制成的改善睡眠的组合物。药理实验表明,该组合物具有良好的镇静、催眠和改善睡眠作用,可用于制备镇静、催眠和改善睡眠的药物和保健食品。
具体实施方式
下面通过实施例具体说明本发明的内容:
实施例1虾青素对睡眠剥夺小鼠免疫功能低下的保护作用
将昆明小鼠随机分为空白对照组、模型对照组、虾青素低剂量组、虾青素中剂量组、虾青素高剂量组。虾青素低、中、高剂量组分别按照50mg/kg、100mg/kg、200mg/kg的剂量ig,连续给药7天,空白对照组和模型对照组每天ig等体积的蒸馏水。在第4天的时候,将模型对照组与虾青素低、中、高剂量组的小鼠采用单平台水环境法进行睡眠剥夺(sleepdeprivation,SD),在SD期间继续给予实验用药。SD连续3天后,采用碳粒廓清实验观察药物对SD小鼠免疫功能的影响,再测定SD小鼠心肝脾肺肾和胰腺的脏器系数。结果表明,与睡眠剥夺组比较,虾青素低、中、高剂量组的廓清指数、吞噬指数及各脏器系数均显著增加(P<0.05),虾青素可明显降低睡眠剥夺所致机体损伤(见表1、表2)。
注:与空白对照组比较a p<0.05,aa p<0.01;与模型对照组比较,b p<0.05,bbp<0.01。
注:与空白对照组比较,a p<0.05,aa p<0.01;与模型对照组比较,b p<0.05,bb p<0.01。
实施例2虾青素与褪黑素组合物对对阈剂量戊巴比妥钠致小鼠睡眠的协同作用
本实施例采用阈剂量戊巴比妥钠的睡眠实验,通过观察小鼠睡眠潜伏期和睡眠持续时间等指标,研究组合物改善睡眠的作用。
实验材料:雄性昆明小鼠(18-20g,雄)80只。所用实验动物均放置于空调、声音和电磁屏蔽的房间内,温度(24±2℃)、湿度(55±15%)。屏蔽室内保持12:12h亮-暗循环。所用实验动物均自由饮食、水,实验前一天应禁食、水,每只小鼠在实验中只能使用一次。50只小鼠随机分为5组,每组10只,分别正常对照组、褪黑素组(M,3mg/kg)、组合物低剂量组(AL+M)、组合物中剂量组(AM+M)和组合物高剂量组(AH+M)。空白组小鼠灌胃给予对照溶剂玉米油,其余各组分别给予受试药物,给药容量为0.1ml/10g,连续给药5天。第5天给药45min后,各组小鼠均腹腔注射戊巴比妥钠(50mg/kg)后,开始记录实验指标。指标记录方法如下:从翻正反射消失到翻正反射恢复,这段时间称为睡眠持续时间。实验结果显示,褪黑素3mg/kg和虾青素中、高剂量组均可显著延长小鼠睡眠时间(P<0.05),褪黑素与虾青素中、高剂量组合用时对延长小鼠睡眠时间发挥极明显的协同作用(P<0.01)(见表3)。说明虾青素与褪黑素联合应用后增强褪黑素调节睡眠、改善睡眠障碍的作用。
注:与空白组比较﹡P<0.05,﹡﹡P<0.01
以上所述,仅为本发明较佳实施例而已,故不能依此限定本发明实施的范围,即依本发明专利范围及说明书内容所作的等效变化与修饰,皆应仍属本发明涵盖的范围内。
Claims (10)
1.一种改善睡眠的组合物,其特征在于:包括质量比为0.1~10:1的虾青素和褪黑素。
2.一种权利要求1所述的组合物在制备改善睡眠的药物中的用途。
3.根据权利要求2所述的用途,其特征在于:所述药物的剂型为口服制剂。
4.根据权利要求3所述的用途,其特征在于:所述口服制剂包括软胶囊、硬胶囊、片剂、丸剂、膏剂、丹剂、口服液。
5.一种权利要求1所述的组合物在制备改善睡眠的保健食品中的用途。
6.根据权利要求2或5所述的用途,其特征在于:所述改善睡眠通过延长睡眠时间实现。
7.一种权利要求1所述的组合物在制备免疫损伤的保护剂中的用途。
8.虾青素在制备免疫损伤的保护剂中的用途。
9.根据权利要求7或8所述的用途,其特征在于:所述免疫损伤由睡眠剥夺导致。
10.根据权利要求7或8所述的用途,其特征在于:所述免疫损伤的保护剂的作用通过增加廓清指数、吞噬指数或脏器系数实现。
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