CN114027508A - 一种改善睡眠的功能性食品γ-氨基丁酸复方制剂 - Google Patents
一种改善睡眠的功能性食品γ-氨基丁酸复方制剂 Download PDFInfo
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Abstract
本发明公开了一种改善睡眠的功能性食品γ‑氨基丁酸复方制剂,所述复方制剂由以下组分组成:金丝小枣、酸枣仁、灵芝、甘草、茯苓、桔梗、浮小麦、γ‑氨基丁酸。本发明的复方制剂组成成分主要为药食同源植物,能显著延迟睡眠时间、缩短入睡时间,有效改善睡眠质量,与临床上治疗睡眠障碍的以苯二氮卓受体激动剂为主要成分的药物相比较,具有毒副作用较小的优势。
Description
技术领域
本发明涉及功能性食品领域,尤其涉及一种改善睡眠的功能性食品γ-氨基丁酸复方制剂。
背景技术
睡眠障碍是严重影响人体身心健康的重大公共问题,据调查,我国约有16.8%的人患有失眠症状。长期失眠不仅影响生活质量,使患者健忘、注意力不能集中、易发生交通伤亡等意外事故,而且会导致认知功能障碍,增加心血管疾病和抑郁症的患病风险。当前临床治疗睡眠障碍的药物主要为苯二氮卓受体激动剂,但长时间服用会产生药物成瘾、认知功能损伤等危害。传统中药具有副作用小的特点,利用中药改善睡眠在我国已有数千年历史,如酸枣仁汤、归脾汤等。但中药化学成分复杂多样,改善睡眠的有效成分及药理作用途径不明确,因此限制了对中药改善睡效果的改进及相关产品开发。随着药食同源理念逐渐深入健康保健意识,从传统中药中开发改善睡眠相关的功能性食品愈加受到关注。目前国内已有改善睡眠功效的功能性食品,但主要是使用褪黑素等原料,长期使用褪黑素有明显的副作用。
现代医学研究显示,失眠与中枢神经系统兴奋性与抑制性氨基酸神经递质的平衡调节密切相关,其中抑制性递质主要是γ-氨基丁酸(GABA),GABA是一种自然界普遍存在的非蛋白质氨基酸,广泛分布于动植物体内,具有很高的生理活性,具有改善睡眠、抗焦虑和抑郁等功能,很多药物通过影响GABA通路来改善睡眠。
发明内容
本发明的目的在于提供一种能够改善睡眠的副作用较小的功能性食品γ-氨基丁酸复方制剂。
为了实现上述目的,本发明的技术思路如下:
导致失眠的原因很多,例如:1、紧张情绪的时候会影响到睡眠:2、思想压力大的时候会出现失眠的现象;3、喝浓茶、喝咖啡等兴奋神经的饮料也可能会引起失眠现象的发生;4、体温升高的时候;5、白天剧烈运动的时候;6、还有一些药物都可能影响到患者的睡眠质量以及影响到患者的睡眠时间;7、疾病因素也可能导致患者引起失眠,如神经衰弱、抑郁症、躯体化障碍等疾病都可能导致患者失眠的现象出现。
红枣含有多种生物活性物质,具有抗氧化、降血压、镇静安神、防治心脑血管疾病、改善记忆力、提高免疫力等功能,是集药、食、补三大功能为一体的药食兼顾的天然保健食品,传统中药多用红枣治疗以失眠为主的神经衰弱症。酸枣仁具有养血柔肝、宁心安神的功效,在改善睡眠方面疗效显著,可以用于长期治疗,是中医临床最常用于治疗失眠的单味药及复方配伍中药,也是最早被列为药食同源的中药之一。灵芝为多孔菌科灵芝属真菌,药用历史悠久,具有安神宁心功效,常用于失眠的改善和治疗,《中华人民共和国药典》2020版记载灵芝具有“补气安神”功效,主治“心神不宁,失眠心悸”。浮小麦为禾本科植物小麦干瘪轻浮的颖果,有补心气、止烦、除热、敛汗、利小便之功。茯苓是药食两用、临床运用最多的大宗和传统中药材,有“十方九苓”之说,具有利水渗湿、健脾宁心等功效,《神农本草经》将茯苓列为上品药材,认为它“久服安魂养神,不饥延年”,民间也常用茯苓调理睡眠。桔梗具有宣肺、祛痰、利咽、排脓的功效,主要含有多种皂苷类成分,桔梗粗皂苷具有镇静、镇痛、解热作用。甘草是临床上应用非常广泛的药物,素有国老之称,有温中益气,清热解毒,调和诸药,解毒等功效。
根据失眠可能发生的原因,本发明的复方制剂组成,选择具有改善睡眠、抗焦虑、镇静安神、补气安神、健脾宁心功效的药食同源植物:金丝小枣、酸枣仁、灵芝、甘草、茯苓、桔梗,浮小麦,并添加一定剂量的γ-氨基丁酸。
本发明设立空白对照组,及3组试验组:(1)γ-氨基丁酸,(2)金丝小枣+酸枣仁+浮小麦+灵芝+甘草+茯苓+桔梗+褪黑激素,(3)金丝小枣+酸枣仁+浮小麦+灵芝+甘草+茯苓+桔梗+γ-氨基丁酸,试验后,测定各组小鼠的延长睡眠时间、30min内小鼠入睡数量、小鼠入睡时间情况,比较3组试验组对睡眠的改善作用,以制备出一种具有改善睡眠作用的功能性食品。
本发明中,所述酸枣仁、灵芝、甘草、茯苓、桔梗、浮小麦为购买至北京康仁堂药业有限公司的配方颗粒,所述金丝小枣为购自陕西森弗天然制品有限公司提取液。
与现有技术相比,本发明的有益效果在于:本发明的复方制剂组成成分主要为药食同源植物,能显著延迟睡眠时间、缩短入睡时间,有效改善睡眠质量,与临床上治疗睡眠障碍的以苯二氮卓受体激动剂为主要成分的药物相比较,具有毒副作用较小的优势。
附图说明
以下结合附图和具体实施方式对本发明做进一步详细说明;
图1是复方制剂对小鼠延长戊巴比妥钠睡眠时间的影响;
图2复方制剂2对小鼠戊巴比妥钠睡眠潜伏期的影响。
具体实施方式
实施例1
复方制剂的成分及实施效果
1复方制剂成分及比例筛选
选择具有改善睡眠、抗焦虑、镇静安神、补气安神、健脾宁心功效的药食同源植物进行配伍:酸枣仁、灵芝、甘草、茯苓、桔梗、浮小麦配方颗粒(均购自北京康仁堂药业有限公司)粉碎后,按重量比例与金丝小枣提取液(购自陕西森弗天然制品有限公司)、γ-氨基丁酸(购自江苏一诺生物科技有限公司)混合,以0.5%羧甲基纤维素钠为溶剂。
2实验方法
根据《允许保健食品声称的保健功能目录非营养素补充剂(2020年版)(征求意见稿)》中,“有助于改善睡眠功能检验方法”的评价试验项目、试验原则及结果判定,检查本发明产品——改善睡眠功能性食品γ-氨基丁酸复方制剂,是否是具有改善睡眠的保健食品。
2.1动物分组
96只雄性清洁级ICR小鼠适应性饲养3d后,随机分为2个批次(n=48),第1批进行直接睡眠实验、延长戊巴比妥钠睡眠实验、戊巴比妥钠睡眠潜伏期实验,第2批进行戊巴比妥钠阈下剂量催眠实验,每批小鼠分为4组(n=12),分别为A组(金丝小枣提取液58.8%、酸枣仁配方颗粒17.7%、灵芝配方颗粒5.9%、甘草配方颗粒2.9%、茯苓配方颗粒2.9%、桔梗配方颗粒1.2%、浮小麦配方颗粒8.8%+γ-氨基丁酸1.8%)、B组(金丝小枣配方颗粒59.4%、酸枣仁配方颗粒17.9%、灵芝配方颗粒6.7%、甘草配方颗粒3.0%、茯苓配方颗粒3.0%、桔梗配方颗粒1.2%、浮小麦配方颗粒8.9%+褪黑素0.03%)、C组(γ-氨基丁酸)、D组(正常对照组),溶剂为0.5%羧甲基纤维素钠溶液,按照5mL/kg剂量灌胃小鼠,正常对照组每日灌胃等量0.5%羧甲基纤维素钠溶液,连续灌胃30d。
2.2直接睡眠实验
灌胃60min内观察小鼠睡眠情况,以小鼠翻正反射消失1min为入睡指标,记录各组小鼠入睡只数及睡眠时间,观察复方制剂对小鼠是否有直接睡眠作用。
2.3延长戊巴比妥钠睡眠时间实验
前期的预实验确定了ICR小鼠的戊巴比妥钠注射剂量为50mg/kg。末次灌胃复方制剂30min后,给小鼠腹腔注射戊巴比妥钠(剂量为50mg/kg,注射量为5mL/kg),观察复方制剂能否延长小鼠睡眠时间。
2.4戊巴比妥钠阈下剂量催眠实验
前期的预实验确定了ICR小鼠戊巴比妥钠阈下剂量催眠剂量为40mg/kg。末次灌胃30min后,给各组小鼠腹腔注射戊巴比妥钠(剂量为40mg/kg,注射量为5mL/kg),记录30min内各组小鼠入睡的数量。
2.5戊巴比妥钠睡眠潜伏期实验
前期的预实验确定ICR小鼠戊巴比妥钠注射剂量为50mg/kg。末次灌胃30min后,给各组小鼠腹腔注射戊巴比妥钠(剂量为50mg/kg,注射量为5mL/kg),观察复方制剂能否缩短小鼠的睡眠潜伏期。
3结果与分析
3.1复方制剂对小鼠直接睡眠的影响
观察各组小鼠灌胃60min内的睡眠只数。由表1可知,各组小鼠活动正常,均无出现翻正消失现象,即各实验组制剂对小鼠均无直接催眠作用。
表1复方制剂对小鼠直接睡眠的影响
3.2复方制剂对小鼠延长戊巴比妥钠睡眠时间的影响
末次灌胃30min后,各组小鼠腹腔注射戊巴比妥钠(剂量为50mg/kg,注射量为5mL/kg),观察小鼠睡眠情况,比较各组小鼠睡眠时间的差异。由图1可知,A组(金丝小枣提取液+酸枣仁提取物+浮小麦提取物+灵芝提取物+甘草提取物+桔梗提取物+茯苓提取物+γ-氨基丁酸)、B组(金丝小枣提取液+酸枣仁提取物+浮小麦提取物+灵芝提取物+甘草提取物+桔梗提取物+茯苓提取物+褪黑素)与D组(正常对照组)比较,能显著延长小鼠睡眠时间(P<0.05),A组、B组、C组之间睡眠时间差异不显著(P﹥0.05),C组(γ-氨基丁酸)与D组(正常对照组)比较,差异不显著(P﹥0.05)。
3.3复方制剂对小鼠戊巴比妥钠阈下剂量催眠的影响
末次灌胃30min后,各组小鼠腹腔注射戊巴比妥钠(剂量为40mg/kg,注射量为5mL/kg),观察30min内各组小鼠入睡的只数。由表2可知,A组(金丝小枣提取液+酸枣仁提取物+浮小麦提取物+灵芝提取物+甘草提取物+桔梗提取物+茯苓提取物+γ-氨基丁酸)和C组(γ-氨基丁酸)的睡眠发生率为50%,高于正常对照组D组的40%,B组(金丝小枣提取液+酸枣仁提取物+浮小麦提取物+灵芝提取物+甘草提取物+桔梗提取物+茯苓提取物+褪黑素)的睡眠发生率为30%,低于正常对照组。
表2复方制剂对小鼠戊巴比妥钠阈下剂量催眠的影响
3.4复方制剂对小鼠戊巴比妥钠睡眠潜伏期的影响
末次灌胃30min后,各组小鼠腹腔注射戊巴比妥钠(剂量为50mg/kg,注射量为5mL/kg),观察小鼠入睡潜伏期,比较各组小鼠睡眠潜伏期的差异。由图2可知,A组(金丝小枣提取液+酸枣仁提取物+浮小麦提取物+灵芝提取物+甘草提取物+桔梗提取物+茯苓提取物+γ-氨基丁酸)、B组(金丝小枣提取液+酸枣仁提取物+浮小麦提取物+灵芝提取物+甘草提取物+桔梗提取物+茯苓提取物+褪黑素)、C组(γ-氨基丁酸)与D组(正常对照组)比较,均能显著缩短小鼠睡眠潜伏期(P<0.05),A组与C组之间差异不显著(P﹥0.05),A组、C组与B组比较,能显著缩短小鼠睡眠潜伏期(P<0.05)。
4结论
根据《保健食品功能评价方法(2020年版)(征求意见稿)》中“有助于改善睡眠功能”的结果判定: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、巴比妥钠睡眠潜伏期实验三项实验中任二项阳性,且无明显直接睡眠作用,可判定该受试样品具有有助于改善睡眠功能的作用。本试验中,试验A组(金丝小枣提取液+酸枣仁提取物+浮小麦提取物+灵芝提取物+甘草提取物+桔梗提取物+茯苓提取物+γ-氨基丁酸)与D组(空白对照组)比较,能显著缩短小鼠睡眠潜伏期,延长小鼠睡眠时间,且明显直接睡眠作用,因此可判定该受试样品(A组)具有有助于改善睡眠功能的作用,但改善睡眠功能的效果,没有比褪黑素的更好。
5基于以上结论,本发明提供了一种改善睡眠的功能性食γ-氨基丁酸复方制剂,所述复方制剂由以下组分组成:金丝小枣提取物、酸枣仁提取物、灵芝提取物、甘草提取物、茯苓提取物、桔梗提取物、浮小麦提取物、γ-氨基丁酸。
实施例2
一种改善睡眠的功能性食品γ-氨基丁酸复方制剂,由以下重量份的组分组成:
实施例3
一种改善睡眠的功能性食品γ-氨基丁酸复方制剂,由以下重量份的组分组成:
实施例4
一种改善睡眠的功能性食品γ-氨基丁酸复方制剂,由以下重量份的组分组成:
Claims (5)
1.一种改善睡眠的功能性食品γ-氨基丁酸复方制剂,其特征在于,所述复方制剂由以下组分组成:金丝小枣、酸枣仁、灵芝、甘草、茯苓、桔梗、浮小麦、γ-氨基丁酸。
2.根据权利要求1所述的一种改善睡眠的功能性食品γ-氨基丁酸复方制剂,其特征在于,所述复方制剂由以下重量份的组分组成:
金丝小枣 58.6-59.0份;
酸枣仁 17.5-17.9份;
灵芝提 5.7-6.1份;
甘草提 2.7-3.1份;
茯苓提 2.7-3.1份;
桔梗提 1.1-1.3份;
浮小麦 8.6-9.0份;
γ-氨基丁酸 1.8份。
3.根据权利要求2所述的一种改善睡眠的功能性食品γ-氨基丁酸复方制剂,其特征在于,所述复方制剂由以下重量份的组分组成:
金丝小枣 58.8份;
酸枣仁 17.7份;
灵芝 5.9份;
甘草 2.9份;
茯苓 2.9份;
桔梗 1.2份;
浮小麦 8.8份;
γ-氨基丁酸 1.8份。
4.根据权利要求1所述的一种改善睡眠的功能性食品γ-氨基丁酸复方制剂,其特征在于,所述酸枣仁、灵芝、甘草、茯苓、桔梗、浮小麦为购买至北京康仁堂药业有限公司的配方颗粒,所述金丝小枣为购自陕西森弗天然制品有限公司提取液。
5.如权利要求1-4任一项所述的一种改善睡眠的功能性食品γ-氨基丁酸复方制剂的制备方法,其特征在于,将酸枣仁、灵芝、甘草、茯苓、桔梗、浮小麦配方颗粒粉碎后,与金丝小枣提取液、γ-氨基丁酸混合,并以0.5%羧甲基纤维素钠为溶剂,混合得到所述复方制剂。
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