CN110269897B - 一种抗疲劳和改善睡眠的组合物及其用途 - Google Patents
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Abstract
本发明公开一种组合物及其用途,所述组合物由包括以下重量份的原料制成:人参2‑4份,枸杞子20‑40份,γ‑氨基丁酸0.5‑1份,香菇40‑70份,低聚木糖5‑8份,蛹虫草1‑3份,酵母‑β葡聚糖1‑3份。本发明组合物通过合理的配方达到了抗疲劳和改善睡眠的双重效果。
Description
技术领域
本发明涉及一种中药组合物,特别涉及一种抗疲劳和改善睡眠的组合物及其用途,属于中药技术现代化创新领域。
背景技术
随着经济社会的发展和竞争的加剧,人们的生活、工作节奏越来越快,压力也随之剧增,疲劳和睡眠问题在人群中成为非常普遍的现象,而且在向年轻化发展。
通常根据疲劳的性质,可以将其分为生理疲劳和心理疲劳两种。生理疲劳又称为体力疲劳,是由于运动引起的肌肉或脑产生的疲劳;心理疲劳也称为脑力疲劳,则是由于心理因素引起的反映在心理现象方面的疲劳。生理疲劳的紧张刺激来源于肌肉的长时间或大强度的运动,主要表现为感觉迟钝、腰酸背痛、动作失调、姿势拙劣、肌肉痉挛等。心理疲劳的紧张刺激则主要来源于心理因素引起的紧张,主要表现为注意力涣散、思维迟钝、反应速度降低,尤其是情绪上的倦怠、厌烦、焦躁、无聊等。
近年来,以心理疲劳为主诉的人群正在逐渐增多,并不同程度地影响到人们的健康及工作质量。目前市场上已经有一些抗疲劳产品,在缓解生理疲劳方面呈现出一定的作用。良好的睡眠对人体健康具有非常重要的作用。调查显示,我国约有5亿人存在睡眠问题,并且有逐年增高的趋势,严重影响人们的精神状态和身体健康。睡眠问题主要包括以下几类:入睡困难、睡眠质量下降和睡眠时间缩短。睡眠问题会直接导致记忆力下降、注意力不集中、工作能力下降,还会引起胸闷、心悸、血压不稳、精神倦怠或情绪不稳定等问题。
引起睡眠问题的原因包括病理性和非病理性因素,病理因素导致的睡眠问题会随着病情康复得以改善。非病理性因素主要来自于心理压力、紧张情绪等,因为大多数人没有时间充分放松和调节心理,精神和身体长期处于紧绷的亚健康状态,睡眠问题不但难以解决,反而会随着时间推移变得更加严重。
现在市场上用于改善睡眠的药物主要是巴比妥类和褪黑素等,这些药品能够缩短入睡时间,延长深度睡眠,但是服用药物后第二天容易产生白天焦虑、精神恍惚,而且容易发生药物依赖性,甚至在停药后还会出现更严重的反弹现象。
从疲劳和睡眠障碍产生的原因看,较大的压力和紧张情绪引起的焦虑等心理因素是二者的共同起因,而且这种因素导致的疲劳和睡眠障碍人群日益增多,但是副作用少、效果好的治疗药物却不多。
中药具有药性温和、不易耐药、适合长期服用等优点,因而较为适合处于亚健康状态人群的机体调节。现在已经有较多文献报道中药在抗疲劳或改善睡眠中的作用,但是,现有的抗疲劳中药组合物仍然存在以下问题:抗疲劳需要兴奋神经,使神经系统处于高效运转和强记忆力状态,而促进睡眠要抑制神经系统使机体处于安静状态,现有产品往往只能顾及一个方面。
此外,心理性因素往往同时造成疲劳和睡眠差两个问题,任一方面的未缓解都会成为另一问题的促进因素,因而即便在一些动物模型中,这些中药使某些生化指标得到改善,但应用到具有心理因素的人群中时,效果却不一定明显。
因此,有必要研究一种能够化解抗疲劳和改善睡眠的矛盾、同时兼顾两方面效果的中药组合物。
发明内容
本发明的目的在于针对现有技术存在的中药组合物配方不合理,难以兼顾抗疲劳和改善睡眠功效的不足,提供一种抗疲劳和改善睡眠的组合物。
本发明提供的中药组合物采用现代医学与传统中草药学结合研究的方法,创新提出多种活性成分相互协调配合促进的中药组合物配方,能够发挥出优秀的抗疲劳和改善睡眠功效作用。
同时,本发明还提供了该组合物的用途,可以将本发明的组合物应用于各种保健养生产品或药品的制备当中。
本发明的上述目的通过以下技术方案来实现:
一种组合物,由包括以下重量份的原料制成:人参2-4份,枸杞子20-40份,γ-氨基丁酸 0.5-1份,香菇40-70份,低聚木糖5-8份,蛹虫草1-3份,酵母-β葡聚糖1-3份。
本发明组合物主要可以用作抗疲劳和改善睡眠,作为优秀的保健养生组合物产品或药品。在组合物配方当中,人参为五加科植物人参(Panax ginseng C.A.Mey)的干燥根,主补五脏,安精神,定魂魄,止惊悸,除邪气,明目,开心益智。现代研究表明,人参含有多种活性物质,其中人参皂苷是人参最主要的活性物质。人参低聚糖能够使小鼠海马区锥体细胞排列紧密有致,人参皂苷与低聚糖均能增强CDK5,MAP2、GAP-43、NF-κB、 p65以及Tau蛋白在海马区的表达,而糖蛋白也可以增强小鼠的学习和记忆功能。人参 RBL和皂苷Rgl能增强胆碱系统的功能,提高人大脑中胆碱受体的浓度,防止人脑中乙酰胆碱含量下降造成老化和记忆功能降低。动物试验表明,人参的活性成分能够显著延长小鼠负重游泳时间,降低血尿素氮,加快乳酸代谢,升高肝糖原,具有抗疲劳的功效。枸杞子为茄科植物宁夏枸杞子LyciumBarbarum L.的干燥成熟果实,性味甘、平,归肝、肾经。富含特殊生物活性功能成分,如隐黄质、玉米黄质、酸浆果红素、甜菜碱、东莨菪碱、牛磺酸、枸杞子多糖等。其中,枸杞子多糖被认为枸杞子主要的功能保健因子,具有保肝、抗高温、抗辐射、抗脂质过氧化、延缓衰老、抗癌抑瘤、降血糖、免疫调节及抗疲劳等作用。枸杞子能减缓慢性心理应激大鼠海马损伤,保护受损伤神经元。
γ-氨基丁酸(GABA)是中枢神经系统中重要的抑制性神经递质,与兴奋性神经递质谷氨酸、天冬氨酸保持着平衡。GABA通过与其受体结合表现出镇静神经、抗焦虑、降低血压、提高脑活力等方面的生理活性。GABA能降低神经元活性,防止神经细胞过热,当人体持续运动后,GABA浓度升高,抑制神经细胞活性和机体能量消耗,对机体起到保护作用,延迟疲劳感的出现。GABA可以通过脑-肠轴、脑膜透过性及其体内代谢物等多条途径产生促进睡眠的综合效果。
香菇的主要成分为香菇多糖,根据现有研究,香菇提取物具有免疫刺激剂功能,以及对抗众多疾病包括动脉粥状硬化、癌症、细菌和病毒感染等的能力。
低聚木糖,又称木寡糖,是由2-7个木糖分子以β-1,4糖苷键结合而成的功能性聚合糖。具有抑制病原菌和腹泻、防止便秘、保护肝脏功能、降低血清胆固醇、能增强机体免疫力等作用。
蛹虫草为子囊菌门,肉座目,麦角菌科、虫草属的模式种。学名为Cordycepsmilitaris(L.ex Fr.)Link.蛹虫草,又叫北冬虫夏草,北虫草,简称蛹草。增强人体免疫功能及抗癌作用。具有耐缺氧、抗衰老、抗惊厥以及保护心脑血管系统的作用。
酵母-β葡聚糖又称为右旋糖酐,具有抗辐射、中和化学毒素、增强免疫功能、修复细胞、调节血脂等作用。
人参、枸杞子、γ-氨基丁酸(GABA)是本发明配方中发挥抗疲劳和改善睡眠作用的主要功能性成分。人参和枸杞子具有抗疲劳、兴奋神经的作用,其作用主要在于对胆碱的调节,并表现出兴奋对记忆力具有重要作用的大脑海马区,而GABA主要作用于中枢神经的GABA受体,表现出镇静、抗焦虑、促进睡眠的作用。当睡眠得以改善后,机体得到恢复,本身能够一定程度上缓解疲劳,而疲劳感的消失或减弱也将提高人的情绪、降低焦虑感,从心理因素上促进睡眠的改善,形成一种良性循环。在一些动物实验中,可以观察到本发明的组合物同时具有显著抗疲劳和改善睡眠的效果。
在一些具体的实施例中,本发明的组合物由包括以下重量份的原料制成:人参2-4份,枸杞子26.8-28.7份,γ-氨基丁酸0.5-1份,香菇40-70份,低聚木糖5-8份,蛹虫草1-2.5份,酵母-β葡聚糖1-3份。
本发明的组合物在人群中的应用研究显示,人参和枸杞子与γ-氨基丁酸的配比影响着组合物在具有心理因素干扰的人群中的治疗效果,基于此,本发明经过大量的研究后获得了优选的组合物,该组合物中人参和枸杞子的合计量与γ-氨基丁酸的量之比为(30.5-47): 1,具有轻度焦虑的人群服用该组合物两周后,睡眠改善有效率达到50%以上。
更优的组合物中人参和枸杞子的合计量与γ-氨基丁酸的量之比为(33-47):1,具有轻度焦虑的人群服用该组合物两周后,抗疲劳有效率大于65%,睡眠改善有效率大于70%。进一步优选的组合物中人参和枸杞子的合计量与γ-氨基丁酸的量之比为(36-43):1,具有轻度焦虑的人群服用该组合物两周后,抗疲劳和改善睡眠的有效率都达到85%以上,效果令人惊喜。
副作用低是中药的巨大优势,特别是药食同源的中药,可以作为食品直接食用,其安全性更高。但是长期服用一些药物仍可能出现一些轻微的副作用。在本发明的一些试验例中发现,连续服用组合物2周后会出现口干的症状,而适量地加入性凉的清热解毒成分后发生率明显降低。因此,作为优选的技术方案,本发明的组合物原料中还含有60-90 重量份的清热解毒组分。优选地,在一些具体实施例中,含有70-80重量份的清热解毒组分。
本发明所述的清热解毒组分是中医药领域技术人员知晓的具有清热凉血、解毒作用,可用于治疗热证的中药或其提取物,尤其优选那些药食同源的清热解毒组分。
根据本发明的一些具体实施例,所述清热解毒组分选自以下组份中的至少一种:菊花、金银花、莲子和蒲公英。尤其值得注意的是,研究人员发现加入蒲公英的组合物,其口干发生率远低于加入其他清热解毒组分的组合物,因而是更加优选的技术方案。
本发明的组合物还可以根据需要加入其它功能性组分,比如具有降低血糖、调节血脂、增强免疫力等作用的组分。
本发明的组合物可以通过将人参、枸杞子、香菇、蛹虫草、清热解毒组分等中药原料打粉后与其他原料混匀制备,也可以将这些中药制备成提取物后与其他原料混匀制备,或者将一部分原料打粉、另一部分原料制备为提取物后与其他原料混匀制备,例如将珍贵药材人参和蛹虫草打粉,其他中药制备成提取物。
对于制备成提取物的技术方案,优选将原料制备为水提取物,制备工艺参考现有文献中提供的方法,例如华中农业大学学报,1997年10月第16卷第413-415页,提供了枸杞子水浸提优化条件;药品鉴定,2009年10月第16卷第19期30、49页,提供了蒲公英水提取工艺;《内蒙古中医药》2008年第11X期58-58页,提供了中药香菇的最佳提取工艺;现代药物与临床,2010年第25卷第4期293-296页,提供了水提金银花最佳工艺;莱阳农学院学报18(1):48-50,2001,提供了水提菊花的优化工艺。
进一步地,本发明组合物还含有药学上可接受的载体和/或辅料。
载体和/或辅料选自填充剂、崩解剂、润滑剂、助悬剂、粘合剂、甜味剂、矫味剂、防腐剂、基质等。
进一步,可以对载体和/或辅料的成分进行筛选如下:
填充剂选自:糊精、淀粉、预胶化淀粉、乳糖、甘露醇、甲壳素、微晶纤维素、蔗糖等。
崩解剂选自:淀粉、预胶化淀粉、微晶纤维素、羧甲基淀粉钠、交联聚乙烯吡咯烷酮、低取代羟丙纤维素、交联羧甲基纤维素钠等。
润滑剂选自:硬脂酸镁、十二烷基硫酸钠、滑石粉、二氧化硅等;助悬剂选自:聚乙烯吡咯烷酮、微晶纤维素、蔗糖、琼脂、羟丙基甲基纤维素等。
粘合剂选自:淀粉浆、聚乙烯吡咯烷酮、羟丙基甲基纤维素等;甜味剂选自:糖精钠、阿斯帕坦、蔗糖、甜蜜素、甘草次酸等。
矫味剂选自:甜味剂及各种香精。
防腐剂选自:尼泊金类、苯甲酸、苯甲酸钠、山梨酸及其盐类、苯扎溴铵、醋酸氯乙定、桉叶油等。
基质选自:PEG6000,PEG4000,虫蜡等。
本发明的组合物可以与辅料和/或载体制备成适宜服用的任意剂型,例如胶囊、口服液、片剂、散剂、颗粒、滴丸等。
在本发明的一些实施例中,向组合物加入适量辅料乳糖、D-甘露糖醇、硬脂酸镁,再用薄膜包衣剂制成片剂,或者灌装成胶囊。
本发明还提供了上述组合物在制备保健食品或药品中的用途。特别是,在制备抗疲劳和改善睡眠的保健食品或药品中的用途。
本发明的有益效果在于:
1、本发明组合物通过合理的配方达到了抗疲劳和改善睡眠的双重效果,弥补了现有中药组合物方案只能解决其一的不足。
2、本发明组合物优选的方案通过调节兴奋神经和抑制神经的组份的配比,提高了组合物在具有心理因素所致疲劳和失眠人群中的有效率,为日益增加的亚健康人群提供了理想的解决方案。
3、本发明组合物优选的方案还通过调整组方,降低了服用者出现口干症状的发生率。
具体实施方式
以下通过具体实施例和试验例对发明内容和效果作进一步的说明和阐述,以使本发明的发明内容和优势更加明显,但不应理解为本发明上述主题的保护范围仅限于以下的实例。本发明以下实施例所用的蒲公英、金银花、菊花、莲子、香菇、枸杞子、人参、酵母-β葡聚糖、蛹虫草、γ-氨基丁酸、低聚木糖、乳糖、D-甘露糖醇、硬脂酸镁、薄膜包衣剂均通过商购获得。
制备实施例1
表1
组合物的制备方法一:按照表1配方分别称重各原料(以100g为1重量份),将人参、蛹虫草、枸杞子、香菇、菊花分别打成细粉,再将这些细粉与其他组份分别过筛,然后加入三维运动混合机中混合20min,混匀,得到组合物A-1。
组合物的制备方法二:按照表1配方分别称重各原料(以100g为1重量份),将枸杞子、香菇、菊花分别按照《华中农业大学学报》,1997年10月第16卷第413-415页,《内蒙古中医药》2008年第11X期58-58页,《莱阳农学院学报》18(1):48-50,2001中所述的最佳提取工艺制备提取物,干燥后粉碎,将人参、蛹虫草打粉,这些细粉与其他组份分别过筛,然后加入三维运动混合机中混合20min,混匀,得到组合物A-2。
散剂:将组合物A-1均匀制为6000份散剂。
片剂的制备:取组合物A-2,加入适量辅料乳糖、D-甘露糖醇、硬脂酸镁,造粒,压片,用薄膜包衣剂制备薄膜衣片6000片;或
胶囊剂的制备:取组合物A-2与适量辅料乳糖、D-甘露糖醇、硬脂酸镁,加入混合机混合20min,混匀,然后在符合GMP的车间,采用胶囊填充机填充胶囊,制得胶囊6000 粒。
试验例一
试验动物:SPF级昆明小鼠,体重18~22g,生产批号:SCXK(川)2015-030。
药品和试剂:戊巴比妥钠,生产批号060222,德国进口分装。用生理盐水分别配置成剂量为46mg/kg和55mg/kg的溶液。
分别取24、12、6份组合物A-1的散剂和组合物A-2的片剂溶于100ml蒸馏水,分别配置成液体,用于组合物高、中、低剂量组。
1、小鼠镇静催眠实验(阈上剂量)
取小鼠70只,体重18~22g,雌雄各一半,依性别不同按体重分层随机分为7组,空白对照组和2个高、中、低剂量组,每组10只;高、中、低剂量组按0.1ml/10g分别灌胃给予组合物A-1和组合物A-2高、中、低剂量组合物液体,空白对照组给予等体积蒸馏水,各组动物每日灌胃给药1次,连续给药20天;末次给药前12h禁食(不禁水),给药后称重,末次给药30min后,按0.1mL/10g小鼠体质量腹腔注射剂量为55mg/kg的戊巴比妥钠溶液(预实验得出),注射后,用手提起小鼠尾部,将小鼠放在温度恒定为37℃的热板上,分别记录注射时间,睡眠潜伏期和睡眠时间。从注射完成到小鼠翻正反射消失的时间段为睡眠潜伏期,从小鼠翻正反射消失到翻正反射恢复的时间段为睡眠时间。判断指标:用手指拨弄小鼠向上仰卧,小鼠在1分钟内没有从仰卧的体位翻转至正常体位,指示它已经进入了翻正反射消失的阶段;小鼠可以在一分钟内从仰卧位置自动地翻转,表明此时翻正反射已经恢复。(翻正反射指动物体位处于异常时所产生的恢复正常体位的反射)。
注:各剂量组与空白对照组比较,*P<0.05,**P<0.01,与组合物A-1组比较,#P<0.05, ##P<0.01。
由表2可知,组合物A-1和A-2高剂量组与空白对照组相比较,无论是睡眠潜伏期还是睡眠时间,均有极显著差异(P<0.01),具有统计学意义。组合物A-1和A-2低剂量组的睡眠时间与空白对照组比较具有极显著差异(P<0.01),具有统计学意义。组合物A-1 和A-2高、低剂量组均能明显延长注射阈上剂量戊巴比妥钠小鼠的睡眠时间,缩短其睡眠潜伏期。组合物A-1和A-2中剂量组与空白对照组比较,无显著差异(P>0.05)。而组合物A-2与组合物A-1相比,高、中、低三个剂量组均无显著差异,说明中药全药打粉和制备为提取物在对小鼠睡眠潜伏期与睡眠时间的影响上无明显效果差异。
2、对小鼠负重游泳时间的影响
取小鼠70只,体重18~22g,雌雄各一半,依性别不同按体重分层随机分为7组,空白对照组和2个组合物高、中、低剂量组,每组10只;组合物高、中、低剂量组按0.1ml/10g 灌胃给予组合物A-1和A-2不同剂量水溶液,空白对照组给予等体积蒸馏水,各组动物每日灌胃给药1次,连续给药20天;实验当天,每只小鼠进行给药后称重并记录,末次给药30min后,在尾部固定上铁丝,放入装有水的5L圆底烧杯中,烧杯中水深30cm,温度恒定为25℃±1℃,铁丝重量为小鼠体质量的10%。记录小鼠从入水开始游泳到力竭的时间。
小鼠力竭判断指标:10s内,小鼠鼻孔不能浮出水面即为力竭。
注:各剂量组与空白对照组比较,*P<0.05,**P<0.01,与组合物A-1组比较,#P<0.05, ##P<0.01。
小鼠负重力竭游泳实验是一种评价小鼠运动能力以及抗疲劳能力的实验,常用于评价受试药物的抗疲劳,增强耐力等药理活性,实验简单易行且廉价高效,小鼠的在落入水中后,受求生本能驱使,不断挣扎使鼻孔露出水面,直至力竭而沉入水中,其游泳时间长短可作为判断小鼠运动能力及抗疲劳程度的依据。具有抗疲劳活性的药物能增加其力竭游泳时间。由表3可知,组合物A-1和组合物A-2高、低剂量组均能显著延长小鼠游泳时间,与空白对照组相比,均具有显著差异(P<0.05);中剂量组与空白对照组相比,无显著差异(P>0.05)。而组合物A-2与组合物A-1相比,高、中、低三个剂量组均无显著差异,说明采用全药打粉入药和制备为提取物在对小鼠负重力竭游泳时间的影响上无明显效果差异。
从动物试验可以看出,本发明的组合物具有抗疲劳,同时改善睡眠的双重作用。将该组合物用于具有疲劳和睡眠障碍的人群,以观察人群使用效果。
试验例二
招募主诉疲劳和失眠的人群共计25人,男13人,女12人,均伴有焦虑情绪。纳入试验标准:初中以上学历保证能够理解量表内容,治疗前一周无用药史,没有其他疾病,符合标准20人,男11人,女9人。试验前采用焦虑自评量表SAS对受试者进行评分,焦虑评分均在50-59分,属轻度焦虑。用药方式,服用组合物A-1的散剂,每天2次,每次3份,连续服用2周,每周随访一次。用药前和随访时以睡眠障碍评定量表SDRS、疲劳量表FS-14评定受试人群失眠和疲劳评分。研究过程中,有2名受试者未能坚持完成试验。最终进入有效分析的人数为18人,男10人,女8人,平均年龄35.1±5.2岁。
疗效标准:参照SDRS和FS-14评分,计算治疗指数R=(基线评分-治疗后评分)/基线评分*100%。对于睡眠改善和抗疲劳,痊愈:R≥80%;显效:30%<R≤79%;无效:R <30%。有效包括痊愈和显效,计算有效率=(痊愈人数+显效人数)/总人数。
治疗结果见下表4。根据表中数据可见,组合物A-1能够发挥抗疲劳和改善睡眠的双重作用,但是抗疲劳有效率不够理想,而且在第2周抗疲劳和改善睡眠的有效率具有下降趋势。
表4组合物A-1对人体抗疲劳和改善睡眠的影响
在动物模型中效果显著的组合物A-1应用到人群中时效果不够理想。研究人员尝试调整组合物A-1的配方,来考察能否改善人群使用效果,经过大量的研究试验后发现,比值 (人参+枸杞子)/γ-氨基丁酸对抗疲劳和改善睡眠具有重要影响。
制备实施例2
根据实施例1制备组合物A-1散剂的方法按照下表5制备组合物B-H的散剂,每组组合物制备6000份散剂。
表5
试验例三
将组合物B-H纳入人群试验中。因为实施例组合物所用成分都是食药两用的原料,可以无需动物试验直接用于人体,而且人体试验能更直观的了解其临床效果,因此不再进行动物试验。
招募主诉疲劳和失眠的受试者175人,纳入标准与试验例二相同,随机分为7组,每组 25人,该7个组分别与试验例二的受试组相比,在焦虑、睡眠障碍和疲劳评分、性别和年龄方面差异不显著(P>0.05),具有可比性。7个组分别服用组合物B-H的散剂,对应观察组1-7,每天2次,每次3份,连续服用2周,每周随访一次。用药前和随访时以睡眠障碍评定量表SDRS、疲劳量表FS-14评定受试人群失眠和疲劳评分。
疗效标准:参照SDRS和FS-14评分,计算治疗指数R=(基线评分-治疗后评分)/基线评分*100%。对于睡眠和抗疲劳,痊愈:R≥80%;显效:30%<R≤79%;无效:R<30%。有效包括痊愈和显效,计算有效率=(痊愈人数+显效人数)/总人数。治疗结果见表6。
表6组合物B-H对人体抗疲劳和改善睡眠的影响
从表6可以看出,与应用组合物A-1的试验例二相比,应用组合物B-G的观察组1-6在抗疲劳和改善睡眠方面的效果更好,服用一周后,抗疲劳有效率均大于45%,达到组合物A-1的两倍以上,同时改善睡眠有效率高于65%,服用两周后,抗疲劳有效率均大于 65%,达到组合物A-1的近三倍,改善睡眠有效率大于70%;尤其是观察组2、3、4,服用一周后,抗疲劳有效率均大于60%,改善睡眠有效率大于70%,服用两周后,抗疲劳和改善睡眠的有效率都达到85%以上,效果令人惊喜。而γ-氨基丁酸占比极低的观察组 7,虽然抗疲劳有效率比组合物A-1略微增高,但改善睡眠的有效率大幅降低,整体上并不比组合物A-1具有优势。
组合物A-1与组合物B、C、E、G、H相比,具有较大效果差异,但组合物的配方仅抗疲劳和改善睡眠组分的比例((人参+枸杞子)/GABA)不同,可见该比例对两种作用的协调具有重要影响。根据试验结果,研究人员推测产生以上效果差异的原因在于:γ-氨基丁酸在促睡眠的同时对情绪产生如抗焦虑和镇静等调节作用,在适当的配比下,γ-氨基丁酸平复服用者情绪并保证较好的睡眠,适量的人参和枸杞子则维持机体在觉醒状态下的高效运转,强化记忆力,消除疲劳感,二者相互协调并相互促进,以发挥最佳效果。当GABA占比过低时,镇静效果可能不足以缓解服用者的紧张、焦虑情绪,因此入睡困难而不能明显改善睡眠,导致体力和脑力不能通过睡眠恢复,也将影响人参和枸杞子抗疲劳效果的体现;而当人参和枸杞子占比过低时,短期内睡眠虽有所好转,精力也略微恢复,但持续性高强度工作仍然对海马区形成较大压力,而且占比高的抑制性GABA不利于调动机体的高效运转,表现出的反应迟钝、记忆力差等疲劳症状仍然明显,在疲劳状态下睡眠问题也不能有效解决。
基于以上研究结果,本发明的组合物,较为优选的技术方案中人参和枸杞子合计量与γ- 氨基丁酸的量之比约为(30.5-47):1;更优地,人参和枸杞子合计量与γ-氨基丁酸的量之比约为(33-47):1,最优地,人参和枸杞子合计量与γ-氨基丁酸的量之比约为(36-43):1。根据观察组3和5的结果可知,在符合上述比例的情况下,将组合物的各成分在所述范围内调整不会对抗疲劳和改善睡眠的有效率产生明显影响。
此外,本发明的研究人员还在试验过程中发现,一些受试者在用药后出现口干症状,而且该症状与抗疲劳和改善睡眠是否有效没有直接关联。经过统计,用药2周后口干症状的发生率(发生人数/有效分析人数)分别为组合物A-1组33.3%,组合物B组32%,组合物C组34.8%,组合物D组50%,组合物E组29.2%,组合物F组32%,组合物G组 33.3%,组合物H组29.2%。推测该症状的发生率与组合物中是否含有清热解毒的成分有关,组合物D组不含有清热解毒组分,发生口干症状的比例最高,达到50%,而其他组口干发生率在29-38%之间。研究人员进一步对配方进行调整,以期获得效果好且副作用低的组合物。
制备实施例3
根据实施例1制备组合物A-1散剂的方法按照下表7制备组合物E-1~E-3散剂,每组组合物制成6000份散剂;按照实施例1制备组合物A-2片剂的方法制备下表7的组合物 E-4片剂,制成6000片薄膜衣片。
表7
试验例四
将实施例3制备的组合物E-1~E-4用于人群服用,受试人群100人,随机均分为4组,分别对应组合物E-1~E-4观察组,纳入标准、用药方法、疗效标准和有效率计算均与试验例二相同(E-4组每天服用2次,每次3片),该4个组分别与试验例二的受试组相比,在焦虑、睡眠障碍和疲劳评分、性别和年龄方面差异不显著(P>0.05),具有可比性。最后进入有效分析的人数为E-1组23人,E-2组25人,E-3组25人,E-4组24人。经统计,用药2周后组合物E-1~E-4的抗疲劳和改善睡眠的有效率都达到85%以上,与组合物E结果相似,符合预期。口干症状的发生率(发生人数/有效分析人数)见表8。
表8
编号 | E-1 | E-2 | E-3 | E-4 |
发生率 | 4.4% | 20% | 28% | 33.3% |
加入清热解毒组分的组合物E-1~E-4与不含此类组分的组合物D相比,其口干症状发生率均降低,特别值得注意的是,含蒲公英的E-1组发生率仅为4.4%,远低于含其他清热解毒成分的试验组。可见蒲公英是此类成分中最适合与本发明的人参、枸杞子等配伍的,能够有效减轻长时间服用具有略微助阳作用的人参带来的轻微副作用。因而含有蒲公英的组合物是更优选的方案。
Claims (8)
1.一种抗疲劳和改善睡眠的组合物,其特征在于,由以下重量份的原料制成:人参2-4份,枸杞子20-40份,γ-氨基丁酸0.5-1份,香菇40-70份,低聚木糖5-8份,蛹虫草1-3份,酵母-β葡聚糖1-3份;其中,人参和枸杞子的合计量与γ-氨基丁酸的量之比为(30.5-47):1。
2.根据权利要求1所述的抗疲劳和改善睡眠的组合物,其特征在于,人参和枸杞子的合计量与γ-氨基丁酸的量之比为(33-47):1。
3.根据权利要求1所述的抗疲劳和改善睡眠的组合物,其特征在于,人参和枸杞子的合计量与γ-氨基丁酸的量之比为(36-43):1。
4.根据权利要求1-3任意一项所述的抗疲劳和改善睡眠的组合物,其特征在于,所述组合物还含有药学上可接受的载体和/或辅料。
5.一种抗疲劳和改善睡眠的组合物,其特征在于,所述组合物由以下重量份的原料制成:人参2-4份,枸杞子20-40份,γ-氨基丁酸0.5-1份,香菇40-70份,低聚木糖5-8份,蛹虫草1-3份,酵母-β葡聚糖1-3份、以及清热解毒组分60-90份;所述清热解毒组分选自以下组份中的至少一种:菊花、金银花、莲子和蒲公英;其中,人参和枸杞子的合计量与γ-氨基丁酸的量之比为(30.5-47):1。
6.根据权利要求5所述的抗疲劳和改善睡眠的组合物,其特征在于,所述清热解毒组分70-80份。
7.根据权利要求5所述的抗疲劳和改善睡眠的组合物,其特征在于,所述清热解毒组分为蒲公英。
8.根据权利要求7所述的抗疲劳和改善睡眠的组合物在制备抗疲劳和改善睡眠的保健食品或药品中的用途。
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Application publication date: 20190924 Assignee: Chengdu Juao Biomedical Technology Co.,Ltd. Assignor: Chengdu University of Traditional Chinese Medicine Contract record no.: X2021980008579 Denomination of invention: Composition for resisting fatigue and improving sleep and use thereof Granted publication date: 20210413 License type: Exclusive License Record date: 20210830 |