CN106692751A - 一种改善运动性失眠的组合物 - Google Patents
一种改善运动性失眠的组合物 Download PDFInfo
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- CN106692751A CN106692751A CN201611244700.0A CN201611244700A CN106692751A CN 106692751 A CN106692751 A CN 106692751A CN 201611244700 A CN201611244700 A CN 201611244700A CN 106692751 A CN106692751 A CN 106692751A
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Abstract
本发明公开了一种包含褪黑素、γ‑氨基丁酸、速溶芦笋粉、柏子仁、维生素B6、5‑羟基色氨酸、茶叶茶氨酸、酸枣仁等成分的组合物,所述组合物能够显著改善运动性失眠。
Description
技术领域
本发明涉及保健食品技术领域,更具体涉及一种改善运动性失眠的组合物。
背景技术
运动性失眠是指因运动训练或比赛前或中精神紧张所致运动员的睡眠不好。激烈的竞争给他们的心理造成强烈冲击,面对提高运动成绩的任务,心理压力更加繁重。加之平日大强度的训练,很容易导致运动员身心疲倦,扰乱正常的生理节律,产生不良情绪,形成失眠。然而失眠又进一步加重疲倦、乏力的感觉,对运动员心理和体力恢复造成障碍,引起疲劳累积,形成恶性循环。
关于运动性失眠的流行病学调查研究显示,运动性失眠的发生率为60.5%,高于同类调查及普通人群,男运动员的发生率为61.4%,女运动员为59.8%,暂时性心理生理性失眠占运动性失眠的95%,只有5%属于持久性心理生理性失眠。运动性失眠是运动性疲劳常见的复杂症候之一,是失眠的一种特殊表现,它对运动员的生理、心理都会带来危害,进而影响运动员竞技能力的发挥,严重的甚至缩短运动寿命。
中医药在治疗失眠方面有其独到的见解,并在长期的临床实践中积累了大量经验,《伤寒杂病论》一书中的黄连阿胶汤、栀子豉汤和酸枣仁汤等方剂都是治疗失眠的良方。但因运动性失眠也只是失眠的一种特殊表现,所以不能完全按临床失眠的标准来衡量。睡眠-觉醒周期是个复杂的生理过程,近年来国内、外有关睡眠的机制研究,多种神经递质参与了睡眠与觉醒生理周期的调控,如,γ-氨基丁酸是哺乳动物中枢神经系统内最重要的氨基酸类神经递质,对神经元的活动分别具有兴奋性及抑制性调控作用;五羟色胺主要分布在脑干背侧中线附近的中缝核等处,多呈抑制效应,脑干中的五羟色胺有利于维持慢波睡眠,而慢波睡眠又有利于疲劳的恢复;某些肽类物质也参与了睡眠-觉醒节律的调节,如褪黑激素等。为能改善运动性失眠,提高睡眠质量,进而提高机体的免疫力,促进运动疲劳的恢复。因此需要研发一种改善运动性失眠的组合物。
发明内容
(一)要解决的技术问题
本发明要解决的技术问题就是如何改善运动性失眠,而提供一种改善运动性失眠的组合物。
(二)技术方案
为了解决上述技术问题,本发明提供了一种改善运动性失眠的组合物,该组合物包括如下重量份的原料:
优选地,所述组合物包括如下重量份的原料:
优选地,所述组合物包括如下重量份的原料:
优选地,所述的组合物还包括赋形剂2-120份。
优选地,所述的组合物包括赋形剂3-110份。
优选地,所述的赋形剂为微粉硅胶、微晶纤维素、交联聚维酮、乳糖、淀粉、羧甲基纤维素钠和硬脂酸镁的一种或几种。
优选地,所述的5-羟基色氨酸中皂甙的含量不低于3.0wt%。
本发明所述的重量份可以是ug、mg、g、kg等医药领域公知的含量单位。
本发明组合物的剂型包括:片剂、丸剂、胶囊、颗粒剂等任何临床可接受的剂型。
本发明组合物所用原料均可市售购得。
本发明组合物可以采用本技术领域中的常规方法制备得到。
(三)有益效果
本发明提供的改善运动性失眠的组合物,将褪黑素、γ-氨基丁酸、速溶芦笋粉、柏子仁、维生素B6、5-羟基色氨酸、茶叶茶氨酸、酸枣仁按特定比例进行复配,通过上述原料的协同作用,显著改善运动性失眠。
具体实施方式
以下,将详细地描述本发明。在进行描述之前,应当理解的是,在本说明书和所附的权利要求书中使用的术语不应解释为限制于一般含义和字典含义,而应当在允许发明人适当定义术语以进行最佳解释的原则的基础上,根据与本发明的技术方面相应的含义和概念进行解释。因此,这里提出的描述仅仅是出于举例说明目的的优选实例,并非意图限制本发明的范围,从而应当理解的是,在不偏离本发明的精神和范围的情况下,可以由其获得其他等价方式或改进方式。
褪黑激素是公认的生理性睡眠因子,它是松果体分泌的一种神经内分泌激素,以色氨酸为原料在松果腺细胞内合成,能通过特异受体介导,对中枢神经起着生物钟作用。研究表明,褪黑激素对视交叉上核有直接作用,视交叉上核上分布有许多褪黑激素受体,褪黑激素与受体结合,通过受体后机制发挥其对生物节律的调节作用,从而参与睡眠时相的调节。褪黑素分泌节律和振幅异常与睡眠觉醒周期障碍、季节性睡眠障碍有关。褪黑素属于内源性睡眠生理调节剂,开发褪黑素类产品解决睡眠障碍问题更合乎生理特点。
γ-氨基丁酸是哺乳动物中枢神经系统内最重要的氨基酸类神经递质,对神经元的活动分别具有兴奋性及抑制性调控作用。研究证明γ-氨基丁酸含量及其受体功能的改变参与睡眠-觉醒过程及不同睡眠时相的转换,在睡眠的调节中发挥着重要的作用。另外,摄入γ-氨基丁酸可以提高葡萄糖磷脂酶的活性,从而促进动物大脑的能量代谢,活化脑血流,增加氧供给量,最终恢复脑细胞功能,改善神经机能。γ-氨基丁酸是国家卫生计生委公告批准的新食品原料。
5-羟基色氨酸(5-hydroxytryptophan,5-HTP)是从加纳籽中提取出来的。是5-羟色胺(5-HT)的前体物质,其代谢途径为色氨酸经色氨酸羟化酶催化首先生成5-HTP,再经5-HTP脱羧酶催化生成5-HT。抑郁症属于情感障碍性疾病,其发病率逐年增加,但由于其发病机制复杂,目前尚未阐明。研究证实抑郁症患者中枢和外周5-HT下降,有效地增加5-HT含量是改善抑郁的重要手段。外源性5-HTP可穿越血脑屏障,间接提高脑内5-HT的浓度从而改善抑郁症。5-HT同时是褪黑素前体,而催眠剂量的褪黑激素可使下丘脑γ-氨基丁酸含量升高,γ-氨基丁酸是中枢神经系统内一个重要的控制性的神经递质,对睡眠-觉醒周期产生抑制作用,从而起诱导睡眠作用。褪黑素、γ-氨基丁酸和5-羟基色氨酸协同诱导对中枢神经系统进行调节,调控睡眠与的觉醒生理周期。
维生素B6参与许多神经递质如(5-羟色胺)的合成与代谢、正常免疫系统的形成与维持。维生素B6在体内储存量约为4g,接近80%以PLP的形式存在于肌肉中,儿茶酚胺的合成、类固醇激素的活性调节也需要依赖PLP的酶系参与。
速溶芦笋粉是纯天然的食品,是用国际公认的防癌保健蔬菜--芦笋为原料,采用纯净水纯天然萃取方法,把芦笋中芦笋皂苷有效成分萃取出来,没有任何药物成分。精神压力、疲劳等造成的血浆皮质醇浓度越高,总睡眠时间越短,睡眠效率越低,睡后总觉醒时间越长。饮用速溶芦笋粉可以显著降低血清皮质醇浓度,缩短入睡时间,延长睡眠时间,提高睡眠效率,减少夜醒次数。本发明采用芦笋皂苷含量≧12.5wt%的速溶芦笋粉。
酸枣仁是中医安神之要药,用于虚烦、失眠、心悸、体虚多汗诸症有显著疗效,而且具有补肝、宁心、敛汗、生津的作用,《神农本草经》将其列为上品,《本草纲目》将其列为本部类,《中药学》列为养心安神类药。酸枣仁皂苷是酸枣仁的主要有效成分,其中主要含有酸枣仁皂苷A、B,研究表明酸枣仁皂苷对于睡眠有较好的调节作用,能增加入睡率,显著缩短睡眠潜伏期,显著延长睡眠时间。本发明采用2wt%皂甙含量的酸枣仁粉。
《中药大辞典》记载,柏子仁具有养心安神,润肠通便等作用。治惊悸、失眠、盗汗、便秘等,多见于改善睡眠的单方或复方。研究表明其主要成分主要是柏子仁脂肪油、柏子仁挥发油和柏子仁甙等,根据我国改善睡眠功能检验标准验证,柏子仁脂肪油、挥发油及甙类对提高实验动物睡眠率,缩短动物入睡时间等方面均具促进作用,与巴比妥钠协同作用,提高实验动物入睡率,缩短实验动物睡眠潜伏期。
天然茶氨酸为L型,是茶叶的特征氨基酸,L-茶氨酸拥有“幸福氨基酸”的美誉。可以促进大脑表面α波(松弛状态)产生,使人体产生舒畅、舒服的感觉,但L-茶氨酸不会引起睡眠状态时发生的θ波数量的增加,因此茶氨酸在使人情绪稳定同时还能使注意力更为集中。另外,茶氨酸对咖啡因刺激作用产生拮抗,因而具有明显安神、松弛神经作用。茶氨酸为国家卫计委批准的新食品原料,经过了严格的检验和审批,其安全性有充分的保证。
以下实施例仅是作为本发明的实施方案的例子列举,并不对本发明构成任何限制,本领域技术人员可以理解在不偏离本发明的实质和构思的范围内的修改均落入本发明的保护范围。除非特别说明,以下实施例中使用的试剂和仪器均为市售可得产品。
实施例1
该组合物含有如下重量的原料:褪黑素0.5g,γ-氨基丁酸50g,速溶芦笋粉50g,柏子仁50g,维生素B6 0.5g,5-羟基色氨酸50g,茶叶茶氨酸100g,酸枣仁250g,微粉硅胶3.5g。
其制备方法:按配方分别称取原料,混合均匀,灌装入胶囊填充模具中,制得胶囊剂。
实施例2
该组合物含有如下重量的原料:褪黑素3g,γ-氨基丁酸100g,速溶芦笋粉100g,柏子仁5g,维生素B6 3g,5-羟基色氨酸50g,茶叶茶氨酸10g,酸枣仁200g,微粉硅胶3.5g。
其制备方法:按配方分别称取原料,混合均匀,灌装入胶囊填充模具中,制得胶囊剂。
实施例3
该组合物含有如下重量的原料:褪黑素0.5g,γ-氨基丁酸50g,速溶芦笋粉100g,柏子仁5g,维生素B6 0.5g,5-羟基色氨酸10g,茶叶茶氨酸50g,酸枣仁200g,微晶纤维素100g,交联聚维酮3.5g,硬脂酸镁3g。
其制备方法:按配方分别称取原料,混合均匀,采用常规片剂加工工艺,制得片剂。
实施例4
该组合物含有如下重量的原料:褪黑素2g,γ-氨基丁酸150g,速溶芦笋粉100g,柏子仁20g,维生素B6 2g,5-羟基色氨酸25g,茶叶茶氨酸60g,酸枣仁150g,微晶纤维素100g,硬脂酸镁3g。
其制备方法:按配方分别称取原料,混合均匀,采用常规片剂加工工艺,制得片剂。
实施例5
该组合物含有如下重量的原料:褪黑素1g,γ-氨基丁酸100g,速溶芦笋粉50g,柏子仁30g,维生素B6 1g,5-羟基色氨酸40g,茶叶茶氨酸80g,酸枣仁200g。
其制备方法:按配方分别称取原料,混合均匀,使用0.8%的羧甲基纤维素钠的水溶液作为粘合剂,采用常规方法,制软材,制丸后烘干并整丸,即得。
实施例6
该组合物含有如下重量的原料:褪黑素3g,γ-氨基丁酸200g,速溶芦笋粉200g,柏子仁5g,维生素B6 1g,5-羟基色氨酸10g,茶叶茶氨酸30g,酸枣仁100g,乳糖80g,淀粉30g,硬脂酸镁3g。
其制备方法:按配方分别称取原料,混合均匀,采用常规片剂加工工艺,制得片剂。
实施例7
该组合物含有如下重量的原料:褪黑素2g,γ-氨基丁酸100g,速溶芦笋粉150g,柏子仁20g,维生素B6 2g,5-羟基色氨酸40g,茶叶茶氨酸50g,酸枣仁150g,微粉硅胶3g。
其制备方法:按配方分别称取原料,混合均匀,灌装入胶囊填充模具中,制得胶囊剂。
实验例:功效试验:
1、实验对象和方法
1.1实验对象
主要为射击和田径运动项目的运动员30人,其中男14人,女16人,具体如下表1所示。
表1:实验对象
平均年龄(岁) | 平均身高(米) | 平均体重(Kg) | 平均运动年限(年) | |
女 | 18.4 | 1.69 | 58.1 | 5.16 |
男 | 18.1 | 1.79 | 66.2 | 5.25 |
整体 | 18.3 | 1.74 | 62.1 | 5.21 |
1.2实验方法
将30人随机分为三组,分别为实验组一、实验组二和对照组。由专人负责,实验组一每天睡前服用2片实施例4中制备的片剂,实验组二服用中国专利申请CN103110709 B公开的一种改善睡眠的组合物及其制备方法中实施例2,对照组服用安慰剂(安慰剂为相同片重的空白片,用淀粉及微晶纤维素混合压制而成),连续3周。
受试者分批在服用前和服用3周后的上午8~9时被抽取肘正中静脉血5ml,血液经肝素抗凝处理,即刻送检。为了避免昼夜节律对生化指标的可能影响,每位受试者前后两次的测试安排在一天中的相同时间。
用RF—510荧光分光分度计(日本岛津),用荧光测试法检测:去甲肾上腺素(NE)、5-羟色胺(5-HT)。使用rHTL-1、rHTL-2(重组人细胞因子标准品,均购自Singma)、CTLL(华西医大免疫教研室传代培养细胞株)、FCS(胎牛血清)、RPMI1640(细胞培养液)(均购自GIBCO公司)等,采用MTT微量酶比色法诱导产生IL-2活性、自然杀伤细胞(NK)活性。
1.3结果统计
所有数据经统计学T检验处理,显著性标准为P<0.05。
2、实验结果
2.1服药前后免疫参数NE、IL-2的比较
表2和表3中分别列出服药前后检测NK比较(%,x±s)和IL-2比较(IU/ml,x±s)
表2
表3
*有显著性差异(P<0.05)
**有非常显著性差异(P<0.01)
NK服药前、后,实验组一有非常显著性差异,实验组二有显著性差异,而对照组无明显差异。
实验组一、实验组二服用前后IL-2都有非常显著性差异,对照组无明显差异。
IL-2、NK可作为评价运动员身体结构和功能的指标之一。机体疲劳时,细胞免疫功能下降,IL-2的增加将有助于T、B淋巴细胞的功能,同时IL-2是有多种功能的细胞因子,在细胞间发送信号,能诱发不同的生物学效应。NK细胞膜表面分子为抗原性不同的糖蛋白,与抗原的识别、细胞的活化、信息的传递、细胞的增殖分化有关。IL-2、NK的含量有不同程度的增加,即运动员的机体免疫力增加。说明实施例4中制备的片剂对帮助睡眠恢复疲劳有较好的效果,可增加大强度训练后运动员的机体免疫力,降低病毒感染率。
2.2服药前后神经递质NE、5-HT的比较
表4和表5分别为服药前后神经递质NE比较(ng/dl,x±s)和5-HT比较(ng/dl,x±s)
表4
表5
NE和5-HT服药前后,实验组一有非常显著性差异,实验组二有显著性差异,而对照组无明显差异。
NE主要位于延髓网状结构、脑桥蓝斑、中脑网状结构,对中枢神经元既有兴奋又有抑制作用,在特定的部位有其特定的作用,常以兴奋作用为主,与脑电激醒有关。5-HT主要分布在脑干背侧正中线附近的中缝核等,多呈抑制效应,脑干中的5-HT有利于维持慢波睡眠,慢波睡眠有利于体力恢复和疲劳的消除,本实验中NE的下降说明脑的兴奋降低,5-HT的上升说明慢波睡眠的延长。说明本发明制备的片剂对帮助睡眠恢复疲劳有较好的效果。
3、结论
运动训练或比赛前或中精神紧张所致运动员的睡眠不好即运动性失眠,服用根据本发明包含褪黑素、γ-氨基丁酸、速溶芦笋粉、柏子仁、维生素B6、5-羟基色氨酸、茶叶茶氨酸、酸枣仁等成分的组合物,能改善运动性失眠,提高睡眠质量,进而提高机体的免疫力,促进运动疲劳的恢复。
Claims (8)
1.一种改善运动性失眠的组合物,该组合物包括如下重量份的原料:
2.根据权利要求1所述的组合物,其特征在于,所述组合物包括如下重量份的原料:
3.根据权利要求1所述的组合物,其特征在于,所述组合物包括如下重量份的原料:
4.根据权利要求1至3中任意一项所述的组合物,其特征在于,所述组合物还包括赋形剂2-120份。
5.根据权利要求1至3中任意一项所述的组合物,其特征在于,所述组合物还包括赋形剂3-110份。
6.根据权利要求4或5所述的组合物,其特征在于,所述赋形剂为微粉硅胶、微晶纤维素、交联聚维酮、乳糖、淀粉、羧甲基纤维素钠和硬脂酸镁的一种或几种。
7.根据权利要求1至3中任意一项所述的组合物,其特征在于,所述5-羟基色氨酸中皂甙的含量不低于3.0wt%。
8.根据权利要求1至3中任意一项所述的组合物,其特征在于,所述组合物的剂型包括:片剂、丸剂、胶囊、颗粒剂临床可接受的剂型。
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