CN108783458A - 促进睡眠愉悦心情预防抑郁症的复方灵芝保健食品 - Google Patents
促进睡眠愉悦心情预防抑郁症的复方灵芝保健食品 Download PDFInfo
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- CN108783458A CN108783458A CN201810772657.8A CN201810772657A CN108783458A CN 108783458 A CN108783458 A CN 108783458A CN 201810772657 A CN201810772657 A CN 201810772657A CN 108783458 A CN108783458 A CN 108783458A
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Abstract
促进睡眠愉悦心情预防抑郁症的复方灵芝保健食品本发明涉及一组由灵芝、酸枣仁和茯苓组成的一组复方制剂具有促进睡眠愉悦心情预防抑郁症的作用,可以作为对人体健康有效而没有不良反应的保健食品。本发明所述的由灵芝、酸枣仁和茯苓组成的保健食品,其特征是其配方由赤灵芝4份、茯苓1份和酸枣仁1份组成的复方制剂,这3种中药的配方比例为4:1:1。该复方制剂可通过现代工艺制备为袋泡茶,保健饮料,片剂,胶囊剂,冲剂,颗粒剂,糖浆剂,供临床应用该保健食品由可以作为食品和药品应用,对各种睡眠障碍,情绪低落等有很好的调节作用,也可用于预防抑郁症。
Description
技术领域
本发明涉及一组促进睡眠愉悦心情预防抑郁症的灵芝保健食品,该保健食品由可以作为食品和药品应用的中药灵芝、酸枣仁和茯苓组成,具有促进睡眠愉悦心情预防抑郁症的作用,对各种睡眠障碍,情绪低落等有很好的调节作用,也可用于预防抑郁症。该配方可通过创新的或常规的生产工艺分别制成保健茶,保健含片,饮料,以及各种可供临床应用的药物制剂,属医学保健的技术领域。
背景技术
失眠,睡不好,这是日常生活中常常听到的主诉,这种症状,在临床医学上称为“睡眠障碍”,睡眠障碍系指睡眠-觉醒过程中表现出来的各种功能障碍,导致睡眠质量下降,在成年人群中长期睡眠障碍者可多至15%。广义的睡眠障碍应该包括各种原因导致的失眠、过度嗜睡、睡眠呼吸障碍以及睡眠行为异常,后者包括睡眠行走、睡眠惊恐等。不同类型的睡眠障碍,应施用不同的治疗方法。如睡眠呼吸暂停多见于肥胖、高血压和任何原因造成的上呼吸道狭窄的患者。美国的临床学家认为,对严重睡眠呼吸暂停的最有效治疗是气管造口术。治疗失眠症最常用的方法是应用安眠药,如苯二氮卓类和巴比妥类药。值得注意的是,安眠类药物中有的易成瘾,有的与酒同服时有危险。长期应用会产生耐药性,需较大剂量才能入睡。此外,长期应用安眠药本身能产生睡眠障碍。故失眠患者应当在医生指导下做到尽可能地合理应用安眠药物。
灵芝为担子菌纲灵芝属真菌,东汉《神农本草经》将灵芝列为上品,《中华人民共和国药典》收载灵芝(赤芝、赤芝)子实体为法定中药材。2000年版《美国草药药典和治疗概要》收载了灵芝。现代医学证明,灵芝含有多种生理活性物质,对人体免疫系统、中枢神经系统等具有良好的功效作用;研究已经证明灵芝具有镇静、催眠等对神经系统的药理作用[林志彬,灵芝研究与开发的现状、问题与对策;中国食用菌,2000, 19(1):31],灵芝具有改善睡眠的作用可通过灵芝多糖调节神经系统,影响松果体对褪黑素的分泌,灵芝多糖还具有显著的拟超氧化物歧化酶(SOD)活性,促进H2O2的清除,对-OH-有清除作用,可显著清除机体产生的自由基,阻止自由基对机体的损伤,减少机体的疲劳,因此,抗氧化作用也有可能是灵芝改善睡眠的作用机制之一;此外,灵芝对中枢神经系统有明显的镇静作用,能使动物的自发性活动减少,肌肉轻度松弛,并能增强巴比妥类药物的中枢抑制作用,但本身并无催眠或麻醉作用,这也可能是灵芝能改善睡眠原因之一。还有研究结果证明灵芝具有免疫调节、抗肿瘤、抗病毒、抗衰老、抗疲劳、降血糖、降血压、消炎等药理作用。
茯苓为多孔菌科卧菌属真菌的干燥菌核,是一种常用中药,始载于《本草经》,味甘淡,性平,有健脾补中、养心安神、利水渗湿的功能,有人通过试验证明羧甲基茯苓多糖注射液具有催眠作用,能增强硫喷妥钠对小鼠中枢的抑制,使小鼠翻正反射消失持续的时间显著延长,增强麻醉效果[陈春霞,羧甲基茯苓多糖对小鼠免疫功能的影响,食用菌,2002,24(4):39-41]。还有人使用东莨菪碱所致记忆获得障碍和30%乙醇所致记忆再现障碍2种模型小鼠,对这2种模型小鼠给药茯苓水提液,证明了茯苓水提液对2种模型小鼠的学习记忆能力均有改善作用[张敏,茯苓水提液对小鼠学习记忆的影响,北华大学学报: 自然科学版,2012,13(1): 62-64]。中医认为抑郁症发病多为气血水津运行失常、影响气机升降出入所致,涉及肺心脾肝肾等脏腑功能。茯苓有利尿渗湿、健脾宁心之功效,广泛用于水肿尿少、痰饮眩晕、脾虚食少、便溏泄泻、心神不安、惊悸失眠等症。现代研究表明,茯苓主要成分有茯苓多糖、茯苓素等,具有利尿、免疫调节、保肝、抗肿瘤、抗氧化、抗炎、抗病毒等多种药理作用,茯苓煎剂特别是茯神注射液,对动物有镇静及催眠作用,茯苓提取物还有降低血铅和骨铅含量,改善大脑记忆功能等作用。临床上治疗抑郁症茯苓主要在复方中应用,单味茯苓的抗抑郁成分及其作用机制还有待进一步深入研究。
酸枣仁是鼠李科植物酸枣的种子成熟后经过干燥处理所得,其性平,味甘、酸,归肝、胆、心经,具有养肝、宁心安神、敛汗的功效。 酸枣仁煎剂可抑制小鼠的自主活动,减少活动次数,对苯丙胺的中枢兴奋有抑制作用。20~80mg/kg的酸枣仁总皂苷和10~40mg/kg的酸枣仁总黄酮均能延长阈上剂量巴比妥钠致小鼠睡眠时间,增加阈下剂量戊巴比妥纳睡眠时间。酸枣仁不饱和脂肪酸能缩短阈上剂量戊巴比妥钠小鼠的睡眠潜伏期,延长睡眠持续期;增加阈下剂量戊巴比妥钠引起的小鼠入睡例数,近年来还发现酸枣仁生物碱有很好的改善睡眠作用。酸枣仁粉剂可以显著提高小鼠脑中和睡眠有关的神经递质5-HT含量,其改善睡眠作用可能与此有关。微透析技术研究显示酸枣仁皂苷A(0.1g/L)能显著拮抗青霉素钠引起的大鼠海马区谷氨酸水平上升,还能拮抗谷氨酸(0.5mmol/L)诱使细胞外Ca2+浓度升高,推测酸枣仁皂苷A可影响海马区由谷氨酸介导的兴奋性信号通路。研究还发现酸枣仁皂苷A调节睡眠的作用还可能是通过调控GABA受体表达的作用实现的。
发明内容
本发明发现由灵芝、酸枣仁和茯苓组成的一组复方制剂具有促进睡眠愉悦心情预防抑郁症的作用,可以作为对人体健康有效而没有不良反应的保健食品。本发明所述的由灵芝、酸枣仁和茯苓组成的具有促进睡眠愉悦心情防治抑郁症的保健食品,其特征是其配方由赤灵芝4份、茯苓1份和酸枣仁1份组成的复方制剂,这3种中药的配方比例为4:1:1。该复方制剂可通过现代工艺制备为袋泡茶,保健饮料,片剂,胶囊剂,冲剂,颗粒剂,糖浆剂,供临床应用。其实施例如下。
具体实施方式:
以下是本发明的具体实施例,对本发明的技术方案做进一步作描述,但是本发明的保护范围并不限于这些实施例,凡是不背离本发明构思的改变或等同替代均包括在本发明的保护范围之内。
实施例一:
复方灵芝袋泡茶的配方及生产工艺:取赤灵芝4份、茯苓1份和酸枣仁1份,把这些药材粉碎成细粉,混合,然后分装为每包20~50克,制备为袋泡茶,应用时用开水渗泡即可服用。
实施例二:
复方灵芝保健饮料的配方及生产工艺:取赤灵芝4份、茯苓1份和酸枣仁1份,将这些中药材按配方比例采集后,粉碎,加15倍量水煎煮二次,每次1.5小时,合并煎液,滤过,滤液浓缩至1:8~12,制备成中药提取液,按照饮料的生产工艺,以5~10%的比例添加进饮料用水中,配成保健饮料。
实施例三:
复方灵芝片剂的配方及生产工艺:取赤灵芝4份、茯苓1份和酸枣仁1份,加10~15倍量水煎煮二次,每次1~2小时,合并煎液,滤过,滤液浓缩至1:5;药渣烤干,加10倍量75%乙醇回流提取二次,每次1小时,合并提取液,减压回收乙醇后与上述浓缩液合并,浓缩至相对密度为1.11~1.18 (80℃),制备成中药提取液,然后,取该中药提取液喷雾干燥,加入辅料,制成颗粒,混匀,压片,制成可供临床应用的片剂。
如本实施例所述的复方灵芝制剂的配方及生产工艺,还可通过现代工艺把这些中药材按配方比例采集后,可以按照中药胶囊剂,冲剂,颗粒剂,糖浆剂的生产方法,添加辅料后制备为中药胶囊剂,冲剂,颗粒剂,糖浆剂,供临床应用。
实施例四:
灵芝助眠制剂的配方及生产工艺:取赤灵芝4份、茯苓3份和酸枣仁3份,加10~15倍量水煎煮二次,每次1~2小时,合并煎液,滤过,滤液浓缩至1:5;药渣烤干,加10倍量75%乙醇回流提取二次,每次1小时,合并提取液,减压回收乙醇后与上述浓缩液合并,浓缩至相对密度为1.11~1.18 (80℃),制备成中药提取液,然后,取该中药提取液喷雾干燥,加入辅料,制成颗粒,混匀,压片,制成可供临床应用的片剂。本配方也可以按照中药胶囊剂,冲剂,颗粒剂,糖浆剂的生产方法,添加辅料后制备为中药胶囊剂,冲剂,颗粒剂,糖浆剂,供临床应用。
实施例五:
为了验证本发明的药理作用,我们进行了灵芝与复方灵芝助眠茶对小鼠镇静催眠药理研究的观察,现介绍如下。
材料,如下。
(1)实验动物:
SPF级昆明小鼠30只,雄性,体重26~30g,由广东医科大学实验动物中心提供,实验动物生产许可证号:SCXK(粤)2013-0008,实验动物使用许可证号:SYXK(粤)2015-0147。分笼饲养(5只/笼),室温保持25℃,自由饮食、饮水。
(2)药品和试剂:
复方灵芝助眠茶按照本发明实施例一的配方与工艺组成,实验时用蒸馏水加热提取10分钟,浓缩到42%,备用。戊巴比妥钠(国药集团化学试剂有限公司,WS20060401),戊巴比妥钠用蒸馏水配制成相应浓度。小鼠γ一氨基丁酸(γ-aminobutyric acid,GABA)酶联免疫吸附(enzyme-linked immunosorbent assay,ELISA)试剂盒、谷氨酸(glutamate,Glu)ELISA试剂盒、谷氨酰胺(glutamine,Gln)ELISA检测试剂盒、5-羟色胺(5-HT)ELISA试剂盒、5-羟吲哚乙酸(5-HIAA)ELISA试剂盒(江苏晶美生物科技有限公司,批号201607)。
(3)仪器:
全自动酶标仪(VT05404-0998,美国伯腾仪器有限公司),智能高速冷冻离心机(YY/T0657-2008,湖南赫西仪器装备有限公司),玻璃匀浆器。
方法,如下。
(1)阈下剂量戊巴比妥钠致小鼠睡眠:
30只雄性KM小鼠,随机分为蒸馏水组(空白对照)、 阳性药物艾司唑仑组、复方灵芝助眠茶组,每组10只,分别给予蒸馏水、0.13%艾司唑仑水溶液、复方灵芝助眠茶水提液,除复方灵芝助眠茶水提液0.3ml/10g/d灌胃其余0.2ml/10g/d灌胃。连续给药8天,在第1天给药灌胃给予对应药物后60min后,各组腹腔注射阈下浓度戊巴比妥钠(使90%-100%小鼠翻正反射不消失的最大剂量,预实验为25mg/kg),0.1ml/10g,观察30分钟内入睡小鼠只数(翻正反射消失1min以上)。
(2)阈剂量戊巴比妥钠致小鼠睡眠:
以上小鼠给药第七天,给予对应药物60min后,腹腔注射阈上浓度戊巴比妥钠量(使100%小鼠入睡的最小剂量,预实验为40mg/kg),0.1ml/10g。计算各组小鼠睡眠潜伏期和睡眠持续时间(各组以注射后小鼠翻正反射消失为入睡指标,小鼠翻正反射恢复为苏醒指标)。
(3)小鼠大脑内GABA,Glu,Gln,5-HT和5-HIAA含量的测定:
以上小鼠第八天最后一次给药60min后给予阈剂量戊巴比妥钠,禁食12小时,所有小鼠于同一时段断颈处死,冰盘上快速分离全脑,用生理盐水洗净,称重,并制备10%的脑组织匀浆,于冷冻离心机3 000 r/min-4℃离心10min,取上清于EP管并保存在-20℃冰箱中.采用ELISA方法按照试剂盒说明书分别测定脑组织中GABA,Glu,Gln,5-HT和5-HIAA含量,尽快在同一时问同一条件下测量。
统计学方法,如下。
采用SPSSl6.0 统计软件进行分析。计数资料采用χ2检验,以百分率表示。计量资料均以x±s表示,多组间比较采用方差分析,方差不齐采用非参数Knlskal-Wallis 检验;P<0.05表示差异有统计学意义。
结果,如下。
(1)对阈下剂量戊巴比妥钠诱导小鼠睡眠的影响:
第1天末次给药60min后,给小鼠腹腔注射戊巴比妥钠25mg/kg(即使用90%~100%的小鼠翻正反射不消失的最大剂量,预实验测得),记录并比较各组小鼠入睡数和入睡率。凡是30min内小鼠翻正反射消失达1min以上者,表明已发生了睡眠。与蒸馏水组比较,复方灵芝助眠茶组和阳性药物组小鼠入睡率明显提高,差异有统计学意义(P<0.01,P<0.05)。阈下催眠剂量戊巴比妥钠诱导小鼠入睡情况比较见表1。
(2)对小鼠戊巴比妥钠睡眠时间的影响:
第7天末次给药60min后,给小鼠腹腔注射戊巴比妥钠40mg/kg(即引起100%小鼠入睡,但又不使睡眠时间过长的最小阈剂量,预实验测得),记录并比较每组小鼠的睡眠潜伏期及睡眠持续时间,看药物是否缩短睡眠潜伏期或延长睡眠持续时间。与蒸馏水组比较,复方灵芝组和阳性对照组睡眠潜伏期明显缩短、睡眠持续时间明显延长,差异有统计学意义(P<0.05)。阈剂量戊巴比妥钠对各组小鼠睡眠的影响见表2。
(3)对小鼠脑内γ-氨基丁酸、谷氨酸、谷氨酰胺含量的影响:
小鼠在第八天末次给药60min后被颈椎脱臼处死,摘取脑组织后用玻璃匀浆器在冰浴条件下充分匀浆,采用ELISA方法按照试剂盒说明书分别测定脑组织中GABA,Glu和Gln含量。与空白组比较,灵芝组、复方灵芝助眠茶组小鼠脑内GABA含量增加,差异有统计学意义(P<0.01);阳性药物组、灵芝组、复方灵芝助眠茶组的Glu和Gln含量均减少,差异有统计学意义(P<0.01)。各组药物对小鼠脑组织中GABA,Glu及Gin的影响结果见表3。
(4)对小鼠脑内5-羟色胺、5-羟吲哚乙酸含量的影响:
脑组织取样同上,然后采用ELISA方法按照试剂盒说明书分别测定脑组织中5-HT和5-HIAA含量。与空白组比较,阳性药物组和灵芝组的5-HT含量增加,差异有统计学意义(P<0.01);但HIAA含量无明显变化。各组药物对小鼠脑组织中5-HT及5-HITT的影响结果见表4。
讨论,如下。
结果表明,复方灵芝助眠茶不但能增加阈下剂量戊巴比妥钠诱导小鼠进入睡眠的个数,而且能显著缩短阈剂量戊巴比妥钠诱导小鼠的睡眠潜伏期、延长阈剂量戊巴比妥钠诱导小鼠的睡眠持续时间。复方灵芝助眠茶导致阈下剂量的戊巴比妥钠小鼠入睡的个数与阳性药物组相当,无统计学意义;对阈剂量戊巴比妥钠诱导小鼠睡眠潜伏期和睡眠时间的作用不及阳性药物。结果提示复方灵芝助眠茶能协同戊巴比妥钠缩短入睡时间,延长睡眠时间,可用于入睡困难、反复易醒的失眠病人,有明显的镇静、催眠作用。
Glu和GABA是中枢神经系统(CNS)中两种主要的氨基酸,GABA是CNS中最主要的抑制性递质,而Glu在CNS含量较高,是兴奋性递质。巴比妥类药物和抗癫痫药苯妥英钠均能增加GABA的神经功能,其机制可能与促进脑内GABA释放有关。为了初步探讨复方灵芝助眠茶中枢抑制作用机制,本研究采用酶联免疫法测定了小鼠脑组织中GABA,Glu的含量,将神经递质的主要来源物质Gln作为观测指标。结果表明:复方灵芝助眠茶明显提高小鼠脑组织中GABA的含量,降低小鼠脑组织中Glu及Gln的含量,提示该药的镇静催眠作用可能与增加CNS中GABA含量、减少Glu含量有关。提示药物可能通过增加抑制性递质GABA合成和增加兴奋性递质Glu代谢而起到中枢抑制的作用。但复方灵芝助眠茶通过何种途径减少兴奋性神经递质Glu的含量增加抑制性递质的含量,与GABA受体是否有关,有待进一步研究。
人在睡眠阶段脑活动表现出一系列主动调节的周期性变化,根据脑电图、眼电图、肌电图和生命体征可以把生理性睡眠分为两时相:快动眼睡眠时相和非快动眼睡眠时相。研究显示,神经递质5-HT是参与了非快动眼睡眠时相,从而影响睡眠。全世建等[全世建,林杏娥,刘妮.PCPA大鼠失眠模型的证候属性研究[J].中医药学刊,2006,24(3):450]利用对氯苯丙胺酸(PCPA)耗尽动物脑内5-HT,成功建立大鼠失眠模型。5-HT经代谢可生成5-HIAA,5-HIAA 的变化也可间接反映5-HT的变化。所以本研究同时测定5-HIAA、5-HT含量,而复方灵芝助眠茶组小鼠脑内5-HT、5-HIAA 含量无明显变化,提示其作用机制与5-HT、5-HIAA的合成无关,与非快动眼睡眠时相无关。
临床观察,如下。
我们在医院门诊病人中随机选择睡眠障碍病例50名,嘱患者应用复方灵芝助眠茶饮用,每日两次,每次一包,冲水服,一连服用一周为一疗程。经过初步观察,发现此制剂对大多数患者都有不同程度的助眠作用。下面举三个实例如下。
病例一、患者甄某某,男,51岁,因到失眠困扰七年,经常要靠服用艾司唑仑等安眠药才能入睡。自从服用复方灵芝助眠茶后,从第五天起,不用再服其他安眠药也能入睡了。目前已经完全停用艾司唑仑,单纯服用复方灵芝助眠茶,也能维持比较好的睡眠。
病例二、患者曾某,女,66 岁,近一年来因为家庭变故,出现睡眠不安稳的症状,主要是早醒,常常是在凌晨两三点钟醒来,就不能再次入睡。由于睡眠时间过少,白天头晕脑胀。自从服用复方灵芝助眠茶第三天后,早醒时间推迟到凌晨三四点,相当多睡了一小时。继续服用到一周后,早醒时间推迟到凌晨五点左右了,目前仍然坚持服用,人的精神面貌有了很大的改观。
病例三、患者黄某某,女,38 岁,因工作压力大,心理有些抑郁,造成睡眠质量下降,经常是在夜间十二点之后才能入睡,而且睡眠中容易惊醒。自从服用复方灵芝助眠茶后,当天晚上便觉得心情好了许多,服用五天后,睡眠质量明显好转。目前只需每晚用用一包,便可以维持疗效了。
Claims (7)
1.一组由灵芝酸枣仁茯苓组成的助眠的保健食品,其特征是其配方由灵芝、茯苓和酸枣仁三种中药组成,这3种中药的配方比例为4: 1:1。
2.如权利要求1所述的一组由灵芝酸枣仁茯苓组成的助眠的保健食品,其特征是制备为复方灵芝袋泡茶的配方及生产工艺是:取赤灵芝4份、茯苓1份和酸枣仁1份,把这些药材粉碎成细粉,混合,然后分装为每包20~50克,制备为袋泡茶,应用时用开水渗泡即可服用。
3.如权利要求1所述的一组由灵芝酸枣仁茯苓组成的助眠的保健食品,其特征是制备为复方灵芝保健饮料的配方及生产工艺是:取灵芝4份、茯苓1份和酸枣仁1份,将这些中药材按配方比例采集后,粉碎,加15倍量水煎煮二次,每次1.5小时,合并煎液,滤过,滤液浓缩至1:8~12,制备成中药提取液,按照饮料的生产工艺,以5~10%的比例添加进饮料用水中,配成保健饮料。
4.如权利要求1所述的一组由灵芝酸枣仁茯苓组成的助眠的保健食品,其特征是制备为复方灵芝片的配方及生产工艺是:取赤灵芝4份、茯苓1份和酸枣仁1份,加10~15倍量水煎煮二次,每次1~2小时,合并煎液,滤过,滤液浓缩至1:5;药渣烤干,加10倍量75%乙醇回流提取二次,每次1小时,合并提取液,减压回收乙醇后与上述浓缩液合并,浓缩至相对密度为1.11~1.18 (80℃),制备成中药提取液,然后,取该中药提取液喷雾干燥,加入辅料,制成颗粒,混匀,压片,制成可供临床应用的片剂。
5.如权利要求1和4所述的一组由灵芝酸枣仁茯苓组成的助眠的保健食品,其特征是制备该配方可通过现代工艺把这些中药材按配方比例采集后,可按照中药胶囊剂,冲剂,颗粒剂,糖浆剂的生产方法,添加辅料后制备为中药胶囊剂,冲剂,颗粒剂,糖浆剂,供临床应用。
6.如权利要求1所述的一组由灵芝酸枣仁茯苓组成的助眠的保健食品,其特征是灵芝助眠制剂的配方及生产工艺是:取赤灵芝4份、茯苓1份和酸枣仁1份,加10~15倍量水煎煮二次,每次1~2小时,合并煎液,滤过,滤液浓缩至1:5;药渣烤干,加10倍量75%乙醇回流提取二次,每次1小时,合并提取液,减压回收乙醇后与上述浓缩液合并,浓缩至相对密度为1.11~1.18 (80℃),制备成中药提取液,然后,取该中药提取液喷雾干燥,加入辅料,制成颗粒,混匀,压片,制成可供临床应用的片剂。
7.如权利要求1和6所述的一组由灵芝酸枣仁茯苓组成的助眠的保健食品,其特征是制备该配方可通过现代工艺把这些中药材按配方比例采集后,可按照中药胶囊剂,冲剂,颗粒剂,糖浆剂的生产方法,添加辅料后制备为中药胶囊剂,冲剂,颗粒剂,糖浆剂,供临床应用。
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