CN107006851A - 一种改善睡眠的保健食品及其制备方法 - Google Patents
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Abstract
本发明公开了一种改善睡眠的保健食品及其制备方法,由玛咖、灵芝孢子粉、酸枣仁、天麻、褪黑色素、生地黄、γ‑氨基丁酸。经过粉碎过筛→预混→制粒干燥→整粒→总混→压片→包衣→内包装→外包→入库制得。本发明安全,无毒性,可口服,口服或食用方便,有显著改善睡眠的保健功能。
Description
技术领域
本发明属于保健品领域,具体的说,涉及一种改善睡眠的保健食品及其制备方法。
背景技术
在中国,成年人失眠率高达39%,青少年的失眠发生率有逐年增高的趋势,而九成以上的老年人有不同程度的失眠,我们国内每年在解决失眠上的花费在千亿人民币以上,给国家、社会和个人造成的经济危害很大。目前虽然有各种针对失眠的疗法,但都存在这样或那样的问题,无法完全解决失眠问题。
情志的变化、饮食内伤,或病后及年迈,禀赋不足,心虚胆怯等病因,引起心神失养或心神不安,从而导致经常不能获得正常睡眠而致失眠。失眠常常表现为入睡困难、睡眠中间易醒及早醒睡眠质量低下、睡眠时间明显减少,有严重的患者还彻夜不眠。失眠是临床常见病症之一,虽不属于危重疾病,但其危害是显而易见的,从短期效应来看,睡眠不足直接影响的是第二天的工作与学习,精神萎靡,疲惫无力,情绪不稳,注意力不集中。而从长远的角度来看,危害更是巨大和深远的:大多数患者长期失眠,越想睡越睡不着,越急越睡不下,易引发焦虑症;同时失眠对于很多人来说都是一诱发某种潜在疾病的可能,如植物神经功能失调,易患神经功能亢进等,出现手脚心多汗,心悸,心跳快,呼吸急阻,肌肉收缩,颤抖,尿急尿频,胸部有压迫感,腹胀而泻,咽部阻碍感,多汗、四肢没力麻木等症状;失眠对人的社会性也会造成极大的危害,由于长期陷入对于睡眠的担心与恐慌中,人会变得多疑、敏感、易怒,以及相当的缺乏自信,这些势必影响其在家庭和工作中各方面的人际关系,从而产生孤独感、挫败感。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。
基于此,需要找到副作用小、性价比高、安全有效且可以长期服用的产品来缓解和治疗失眠,保健食品是最好的选择之一。
因此,提供一种新的改善睡眠产品具有现实意义。
发明内容
为解决以上技术问题,本发明的目的之一在于提供一种起效快,显著改善睡眠的保健品。
本发明的目的之二在于提供一种起效快,显著改善睡眠的保健品制备方法。
本发明目的之一是这样实现的:
一种改善睡眠的保健食品,按重量份数包含以下组分:
上述保健食品还添加有药用辅料。
上述保健食品为口服液、饮料、片剂、胶囊、喷雾剂或透皮吸收剂。本保健食品的给药方式为口服或外用。所述本保健食品的服用方式为每日1~2次,每次100-1000mg/kg体重。
本发明目的之一是这样实现的:
一种改善睡眠的保健食品制备方法,按如下步骤进行:原辅料粉碎过筛→预混→制粒干燥→整粒→总混→压片→包衣→内包装→外包→入库。
本保健食品应用于纠正不易入睡、睡眠很浅、多梦、易醒、睡眠不足和无法入睡等睡眠不良现象。
以下为本保健品的主要成分。
酸枣仁
酸枣仁,别名枣仁、酸枣核、山枣仁。由鼠李科乔木酸枣成熟果实去果肉、核壳,收集种子,晒干而成。生于向阳山坡、路旁,主要产于河南、河北、陕西、辽宁、山西、山东、云南等地。秋季果实成熟时采收,去果肉及硬核,取种子,生用或微炒用。
中国最早的一部药书《神农本草经》中记载:“补中益肝,坚筋骨,助阴气,皆酸枣仁之功也。”明代李时珍《本草纲目》中记载,枣仁“熟用疗胆虚不得眠,烦渴虚汗之症;生用疗胆热好眠,皆足厥阴少阳药也。
酸枣仁的主要成分为酸枣仁皂苷(jujuboside)、白桦脂酸、桦木素等,含油脂约32%,另外,也含有多量脂肪油和蛋白质、甾醇、三萜类、多量维生素C等。
酸枣仁的主要功能包括
1.镇静、催眠作用:
酸枣仁煎剂给大白鼠口服或腹腔注射均表现镇静及嗜眠,无论白天或黑夜,酸枣仁均能表现上述作用。小白鼠口服时的镇静指数为1.95,与巴比妥类药物表现协同作用,酸枣仁被连续使用6天后,动物睡眠会变浅,持续时间缩短,即产生耐受性,但停药1周后可消失。
2.安定作用:
近年来有人将酸枣仁与安定药比较,发现有许多相似之处。酸枣仁煎剂给大鼠腹腔注射后,所有动物表现安静和嗜睡。但外界刺激可使之惊醒。加大剂量到中毒剂量,小鼠亦未出现翻正反射消失和麻醉。煎剂给小鼠灌胃后可抑制条件反射,而不抑制非条件反射。对皮下注射盐酸吗啡使猫产生的狂躁现象,酸枣仁也有显著的对抗作用。
生地黄(dried rehmannia root)
为玄参科植物地黄的块根。别称生地、地髓、原生地、干生地、苄、芑、牛奶子、婆婆奶界。为多年生草本,全株有白色长柔毛和腺毛。
地黄有效成分包括地黄素、多种环烯醚萜、单萜类、多种酸类成分和甙类,另外,地黄中含有20多种氨基酸,其中以精氨酸含量最高;干地黄中有15种氨基酸,其中丙氨酸含量最高.地黄中还含有铁、锌、锰、铬等20多种微量元素.
其对中枢神经系统的作用包括明显镇静作用,其作用部位可能在大脑皮层.其水提取液可抑制小鼠的自主活动,并能加强阈下催眠剂量戊巴比妥钠和硫喷妥钠的催眠作用,同时也能对抗安钠咖的兴奋作用,但不能对抗硝酸士的宁和戊四氮所致的惊厥作用.地黄的镇静作用有利于缓解高血压病人的症状,明显改善高血压病人引起的失眠,有效率达94%.有人认为地黄的镇静成分主要为水溶物,口服地黄水煎浸膏剂、醇浸剂或腹腔注射10g/kg
天麻
天麻(学名:Gastrodia elata Bl.),又名赤箭、独摇芝、离母、合离草、神草、鬼督邮、木浦、明天麻、定风草、白龙皮等,是兰科天麻属多年生草本植物。根状茎肥厚,无绿叶,蒴果倒卵状椭圆形,常以块茎或种子繁殖。
天麻富含天麻素,香荚兰素,蛋白质,氨基酸,微量元素。其性辛、温、无毒,有抗癫痫,抗悸厥,抗风湿;镇静,镇痉,镇痛,补虚,平肝息风的功效。
天麻浸膏有明显对抗戊四氮阵挛性惊厥作用;天麻甙可减轻马桑内酯诱发的家兔癫痫发作程度。天麻注射液有镇静、安眠作用。
灵芝孢子Ganoderma spore)
灵芝孢子粉是灵芝在生长成熟期,从灵芝菌褶中弹射出来的极其微小的卵形生殖细胞即灵芝的种子。每个灵芝孢子只有4-6个微米,是活体生物体,双壁结构,外被坚硬的几丁质纤维素所包围,人体很难充分吸收。破壁后更适合人体肠胃直接吸收。它凝聚了是灵芝的精华,具有灵芝的全部遗传物质和保健作用。
灵芝孢子的主要成分包括灵芝多糖,三萜类灵芝酸,天然有机锗,腺嘌呤核苷和微量元素硒。
据北京、武汉等有关医院用灵芝孢子粉治疗神经衰弱患者108例,30天为1个疗程,连服2-3个疗程。结果:患者的失眠多梦、心悸健忘、腰腿酸软、神疲乏力、烦躁等各种症状有明显改善,有效率为90%以上。
褪黑素(melatonin)
又称为美拉酮宁、抑黑素、松果腺素,分子式为N-乙酰基-5-甲氧基色胺,是存在于从藻类到人类等众多生物中的一种荷尔蒙,它在生物中的含量水平随每天的时间变化而变化。
褪黑激素(Melatonin)主要是由哺乳动物和人类的松果体产生的一种胺类激素。人的松果体是附着于第三脑室后壁的、豆粒状大小的组织。也有报导哺乳动物的视网膜和副泪腺也能产生少量的褪黑激素;某些变温动物的眼睛、脑部和皮肤(如青蛙)以及某些藻类也能合成褪黑激素。褪黑激素的分子式为C13N2H16O2,分子量232.27,熔点116℃~118℃,化学名称为N-乙酰基-5-甲氧基色胺(N-acetyl-5-methoxytryptamine)。
褪黑色素可以改善睡眠,能缩短睡前觉醒时间和入睡时间,改善睡眠质量,睡眠中觉醒次数明显减少,浅睡阶段短,深睡阶段延长,次日早晨唤醒阈值下降。有较强的调整时差功能。主要用于增白保湿化妆品,也常用于生发制品中。国内外对褪黑激素的生物学功能,尤其是作为膳食补充剂的保健功能进行了广泛的研究,表明其具有促进睡眠、调节时差、抗衰老、调节免疫、抗肿瘤等多项生理功能。国内外有关褪黑激素的保健功能涉及调节内分泌(抑制排卵),对脑炎病毒感染有保护作用,并降低其感染后的死亡率,AIDS的治疗和心血管的保护作用等。
玛咖(Maca)
玛咖(Lepidiummeyemi i Walp),是十字花科独行菜属一年生或两年生草本植物,原产秘鲁中部海拔4000m以上的安第斯山区。由于Maca耐低温、大风,能在恶劣的生态条件下生长,成为当地主要作物之一。主要食用部位是根,地下膨大的贮藏根直径2~5cm,表面颜色大多为黄色或紫色,肉质白色或淡黄色,具有刺激性气味和特殊的咸味奶油糖果气味。目前,玛咖的高产地(栽培品为主)仍在安第斯山脉卡华玛沃地区(Carhuamayo)和胡宁区(Junin)。引种至秘鲁其他地区或国外德国、捷克等地的情况不佳,发育不良未获得满意的结果。玛咖适宜生长地为海拔4000~4500m的高寒、强风及高日照地区。
玛咖(Maca)是药食兼用的植物,特产于南美洲秘鲁,当地印加人将其用做,补药,称其为秘鲁人参。在南美秘鲁等地,玛咖根鲜用时可与肉或其它蔬菜一起炒熟食用,晒干后则用水或牛奶煮熟即可食用,数千年来,玛咖根作为食物和草药用于增强精力,抗疲劳,改善性功能,提高生育力,治疗女性更年期综合征等。
γ-氨基丁酸(γ-aminobutyric ac id,GABA)
γ-氨基丁酸是广泛分布于动物体内的一种重要的抑制性神经递质,是一种天然存在的非蛋白组成氨基酸,具有极其重要的生理功能,它参与多种代谢活动,在大脑皮质、海马、丘脑、基底神经节和小脑起重要作用,并对机体的多种功能具有调节作用,包括促进脑的活化性,健脑益智,促进睡眠,美容润肤,延缓脑衰老机能;参与产生镇静、镇痛效应、抗焦虑、防治惊厥、舒缓血管和降血压、防止动脉硬化调节心律失常以及调节生殖生理激素的分泌的功能。正是由于具有的多种生理功能,γ-氨基丁酸在医药、保健品、食品、饲料添加剂等领域具有广泛的应用。2009年,卫生部更是批准γ-氨基丁酸为新资源食品。
以L-谷氨酸钠为原料经希氏乳杆菌(Lactobacillus hilgardii)发酵、加热杀菌、冷却、活性炭处理、过滤、加入调配辅料(淀粉)、喷雾干燥等步骤生产而成的伽马氨基丁酸才是食品级的,可以在饮料、可可制品、巧克力和巧克力制品、糖果、焙烤食品、膨化食品等地方添加。
实验
1.直接睡眠实验:观察给药组和对照组动物是否出现睡眠现象。睡眠以翻正反射消失为指标。当小鼠置于背卧时,能立即翻正身位,如超过30~60秒不能翻正者,即认为翻正反射消失,进入睡眠。翻正反射恢复即为动物觉醒,翻正反射消失至恢复这段时间为动物睡眠时间。观察未发现给予本保健食品及酸枣仁后动物有直接睡眠现象。
2.延长戊巴比妥钠睡眠时间实验:选取ICR小鼠(16~20g)10只,于实验室适应7d后,随机分为5组,每组20只,雌雄各半,分别为:本保健食品高、中、低剂量组,艾司唑仑对照组,空白组。各组小鼠灌胃给药,空白组给予蒸馏水,本保健食品高剂量组(600mg/kg),中剂量组(400mg/kg),低剂量组(200m g/kg),艾司唑仑对照组(0.26×10-3g/kg),每日灌胃给药1次,连续给药7d。各组小鼠在末次给药之前应禁食12h,饮水自由。正式实验前先进行预试验,确定使动物100%入睡,但又不使睡眠时间过长的戊巴比妥钠剂量(30-60mg/kg),用此剂量正式实验。预实验确定使用戊巴比妥钠剂量为45mg/kg。动物末次给药后1h,给各组动物腹腔注射戊巴比妥钠,注射量为0.2ml/20g,在末次给予受试制剂后30min各组小鼠经腹腔注射浓度为50mg/kg的戊巴比妥钠,注射的剂量为10ml/kg,观察小鼠翻正反射的消失时间和恢复时间,以翻正反射消失为睡眠标准,记录小鼠睡眠的持续时间和睡眠潜伏期,睡眠潜伏期是注射戊巴比妥钠的开始时间到翻正反射的消失时间,睡眠持续时间则是入睡后到翻正反射的恢复时间。
睡眠时间为计量资料,采用方差分析,但需按方差分析的程序先进行方差齐性检验,计算F值,F值<F0.05,结论:各组均数间差异无显著性;F值≥F0.05,P≤0.05,用多个实验组与一个对照组间均数的两两比较方法进行统计;对非正态或方差不齐的数据进行适当的变量转换,待满足正态或方差齐性要求后,用转换后的数据进行统计;若变量转换后仍未达到正态或方差齐的目的,应改用秩和检验进行统计。对睡眠时间数据进行比较,结果如表1。
从表1可以看出给予本保健食品组(大、中、小剂量),相对对照组,睡眠时间有所增加,差异显著(P<0.05-0.01),说明本保健食品对睡眠时间有一定的改善作用。
3.戊巴比妥钠睡眠潜伏期实验:
ICR小鼠(16~20g)100只,分为5组,每组20只,为别为对照组control,艾司唑仑对照组(0.26×10-3g/kg),本保健食品大剂量组(600mg/kg),本保健食品中剂量组(400mg/kg),本保健食品小剂量组(200mg/kg)。每天灌胃给药一次,连续给药10天后实验。动物末次给药后1h,给各组动物腹腔注射戊巴比妥钠45mg/kg,注射量为0.2ml/20g,以翻正反射消失为指标,记录注射戊巴比妥钠结束到翻正反射消失时间为睡眠潜伏期。如实验2比较方法比较各组睡眠潜伏期时间间差异,结果如表2。
从表2可以发现给予艾司仑、本保健食品各个剂量,均缩短了实验动物的入睡潜伏期时间,均有显著性(p<0.05-0.01),具典型的量效关系。
4.本保健食品对阈下剂量戊巴比妥钠诱导睡眠百分率的影响
ICR小鼠(16~20g)100只,分为5组,每组20只,为别为对照组control,艾司唑仑对照组(0.26×10-3g/kg),本保健食品大剂量组(600mg/kg),本保健食品中剂量组(400mg/kg),本保健食品小剂量组(200mg/kg)。每天灌胃给药一次,连续给药10天后实验。正式实验前先进行预实验,确定戊巴比妥钠阈下催眠剂量(戊巴比妥钠16-30mg/kg.bw),即80-90%小鼠翻正反射不消失的戊巴比妥钠最大阈下剂量。预实验确定戊巴比妥钠阈下催眠剂量为28mg/kg。动物末次给药1h后,各组动物腹腔注射戊巴比妥钠28mg/kg,记录30分钟内入睡动物数(翻正反射消失达1分钟以上者)。入睡动物数为计数资料,用X2检验,四格表总例数小于40,或总例数等于或大于40但出现理论数等于或小于1时,应改用确切概率法。比较对照组与实验组入睡动物数之间的差异,结果见
表3.
从表3结果分析,酸枣仁、本保健食品各个剂量都明显的(p<0.05-0.01)增加了入睡动物数,其中,大剂量组增加入睡动物数50%以上,这些说明酸枣仁和本保健食品均能明显改善睡眠。
根据保健品改善睡眠功能检验方法,延长戊巴比妥钠睡眠时间实验、戊巴比妥钠(或巴比妥钠)阈下剂量催眠实验、戊巴比妥钠睡眠潜伏期实验三项实验中二项阳性,且无明显直接睡眠作用,可判定受试样品改善睡眠功能动物实验结果阳性。以上实验结果说明本保健食品具有改善睡眠功能。
本发明涉及本保健食品在改善睡眠上的用途。本发明经动物实验证实本保健食品对睡眠有明显的改善作用,具有无毒性,安全,可口服,可食用等优点。
本发明发现本保健食品在改善睡眠的功能检验方法实验中呈阳性,本保健食品不能引起实验动物直接睡眠,能缩短实验动物戊巴比妥钠基础上的入睡潜伏期,在戊巴比妥钠阈下剂量催眠实验中明显增加睡眠动物数,对睡眠有很好的改善作用。
本保健食品改善睡眠的具体研究,对于确认其改善睡眠以及其保健功能有现实意义和应用价值。
本发明的优点是:
1.安全,无毒性,可口服。
2.对本保健食品的功能做了新的探索,在其原知功能基础上做了很好补充,发现其改善睡眠作用。
3.本保健食品在改善睡眠功能检测中不仅缩短入睡潜伏期,还增加入睡实验动物数,在一定程度对睡眠时间有帮助。
4.本保健食品口服或食用无毒,给药方便,有保健功能,推荐人用剂量约为玛咖每天不超25克(60kg.BW),γ-氨基丁酸每天用量不超过500毫克(60kg.BW),生地黄每日用量为不超过30克(60kg.BW)。
具体实施方式
下面结合实施例对本发明作进一步说明。
实施例1:
一种改善睡眠的保健食品,按重量份数配制以下组分:
加2份药用辅料微晶纤维素和1份药用辅料硬脂酸镁,制作为片剂。
然后将原辅料粉碎过筛→预混→制粒干燥→整粒→总混→压片→包衣→内包装→外包→入库。
根据每日1~2次,每次100-1000mg/kg体重的用量,还可以生产为口服液、饮料、胶囊、喷雾剂或透皮吸收剂。
实施例2:
一种改善睡眠的保健食品,按重量份数配制以下组分:
加2份药用辅料微晶纤维素和1份药用辅料硬脂酸镁,制作为片剂。
然后将原辅料粉碎过筛→预混→制粒干燥→整粒→总混→压片→包衣→内包装→外包→入库。
根据每日1~2次,每次100-1000mg/kg体重的用量,还可以生产为口服液、饮料、胶囊、喷雾剂或透皮吸收剂。
实施例3:
一种改善睡眠的保健食品,按重量份数配制以下组分:
加2份药用辅料微晶纤维素和1份药用辅料硬脂酸镁,制作为片剂。
然后将原辅料粉碎过筛→预混→制粒干燥→整粒→总混→压片→包衣→内包装→外包→入库。
根据每日1~2次,每次100-1000mg/kg体重的用量,还可以生产为口服液、饮料、胶囊、喷雾剂或透皮吸收剂。
最后需要说明的是,上述描述仅仅为本发明的优选实施例,本领域的普通技术人员在本发明的启示下,在不违背本发明宗旨及权利要求的前提下,可以做出多种类似的表示,这样的变换均落入本发明的保护范围之内。
Claims (4)
1.一种改善睡眠的保健食品,按重量份数包含以下组分:
2.根据权利要求1所述一种改善睡眠的保健食品,其特征在于:所述保健食品还添加有药用辅料。
3.根据权利要求1所述一种改善睡眠的保健食品,其特征在于:所述保健食品为口服液、饮料、片剂、胶囊、喷雾剂或透皮吸收剂。
4.一种如权利要求1-2所述一种改善睡眠的保健食品制备方法,按如下步骤进行:原辅料粉碎过筛→预混→制粒干燥→整粒→总混→压片→包衣→内包装→外包→入库。
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