CN114939149A - 一种清咽缓解体力疲劳组合物及其应用 - Google Patents
一种清咽缓解体力疲劳组合物及其应用 Download PDFInfo
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Abstract
本发明提供了一种清咽缓解体力疲劳组合物,制备所述组合物的原料包括按如下重量配比的:黄精5‑8份、枸杞5‑8份、蛹虫草2‑3份、人参2‑3份、罗汉果4‑6份、金银花4‑5份、蒲公英4‑6份。本发明将黄精、枸杞、蛹虫草、人参、罗汉果、金银花、蒲公英,七种中药合理组合,协同作用,兼具缓解体力疲劳和清咽的作用。
Description
技术领域
本发明属于中药技术领域或保健食品技术领域,具体涉及一种清咽缓解体力疲劳组合物及其应用。
背景技术
随着生活节奏的加快,工作压力的增大,疲劳已成为当代社会中很常见的一种状态。研究发现,有大于50%的人们会感到疲劳,其中大于33.3%的人们明确表示疲劳对生活质量和工作效率有严重的影响。疲劳是一种不可避免的生理现象,由多种原因共同导致,常伴随着巨大的压力和过度的体力或脑力活动而出现。体力疲劳又称运动性疲劳,指由于运动引起机体生理生化改变而导致机体运动能力暂时降低的现象,是机体出现的氧化应激反应,它不仅标志着机体原有工作能力的暂时下降,而且可能是机体处于损伤状态的表现。机体通常可以通过休息从正常的疲劳症状中恢复过来,而如果不能有效地缓解疲劳,就会影响人体健康,增加与免疫系统有关疾病的发病率,甚至引起癌症、高血压、冠心病等多种疾病。
现今的药剂及保健食品缓解体力疲劳效果不是特别理想同时效果单一,本组合物主要是针对亚健康人群疲劳状态和咽喉疼痛或不适感(吸烟人群)等症状而设计。尤其是考虑到吸烟人群该类患者的症状表现为咽喉疼痛或者不适感同时疲劳乏力,现有药剂的作用并不明显。
发明内容
针对所述问题,本发明提供了一种清咽缓解体力疲劳组合物,制备所述组合物的原料包括按如下重量配比的:黄精5-8份、枸杞5-8份、蛹虫草2-3份、人参2-3份、罗汉果4-6份、金银花4-5份、蒲公英4-6份。
优选地,制备所述组合物的原料包括按如下重量配比的:黄精5份、枸杞5份、蛹虫草2份、人参2份、罗汉果4份、金银花4份、蒲公英5份。
进一步地,制备所述组合物的原料还包括药学或保健品中可接受的辅料。
进一步地,所述辅料包括粘合剂、矫味剂、助流剂、润滑剂的一种或多种。
进一步地,所述辅料包括胶化淀粉、微晶纤维素、山梨糖醇、乙醇、薄荷脑、硬脂酸镁。
进一步地,所述的组合物可制成片剂、口服液、颗粒剂、胶囊等剂型。
本发明还提供了所述组合物在制备缓解体力疲劳和/或清咽的药物、保健品中的应用。
本发明通过将7种药材合理配伍使其产生协同作用,兼具缓解体力疲劳和清咽的有益效果,由本发明制备的药剂药效稳定,具有较理想的保存期限。
上述组分中方中人参甘、微苦,微温。归脾、肺、心、肾经。有大补元气,复脉固脱,补脾益肺,生津养血,安神益智之功效。适用于用于体虚欲脱,肢冷脉微,脾虚食少,肺虚喘咳,气血亏虚,久病虚羸等症。黄精甘,平。归脾、肺、肾经。有补气养阴,健脾,润肺,益肾之功效。适用于用于脾胃气虚,体倦乏力,胃阴不足,肺虚燥咳,精血不足,腰膝酸软等症。枸杞甘,平。归肝、肾经。有滋补肝肾,益精明目之功效。适用于虚劳精亏,腰膝酸痛,眩晕耳鸣,阳萎遗精等症。蛹虫草是一种常用的食药用真菌,入肺肾二经,既能补肺阴,又能补肾阳,主治肾虚,病后虚弱等。罗汉果甘,凉。归肺、大肠经。有清热润肺,利咽开音,滑肠通便之功效。适用于肺热燥咳,咽痛失音等症。金银花甘,寒。归肺、心、胃经。有清热解毒,疏散风热之功效。适用于痈肿疔疮,喉痹,风热感冒,温病发热等症。蒲公英苦、甘,寒。归肝、胃经。有清热解毒,消肿散结,利尿通淋之功效。适用于疔疮肿毒,目赤,咽痛,肺痈,热淋涩痛等症。
亚健康状态属于中医“虚劳”范畴,虚劳归根结底就是元气亏损。元气者人身主命之光。元气充盛则脏腑功能强健,元气虚损则羸弱疲劳多病。
方中人参大补元气,健脾益肾润肺,生津安神,药效全面而抗疲劳药效显著,选定为方中之主药;辅以枸杞子滋补肝肾,益精明目;黄精补气养阴健脾益肾;蛹虫草补阴助阳,润补阴阳。四药合用,共辅人参壮元气、抗疲劳之功效。
中医认为“正气存内,邪不可干”,“邪之所凑,其气必虚。”元气亏虚,必定引邪内侵。疲劳状态中的咽喉疼痛或不适感就是正气虚损招致的邪气表现。所以扶正之时,必须祛邪。佐以蒲公英清热解毒,消肿散结以除咽痛,金银花清热解毒,疏散风热以除喉痹,罗汉果清热润肺以利咽开音。三药合用,在扶正的基础上能更好的发挥祛邪解毒利咽药效。
本方配伍特别注意补气而不滞腻,祛邪而不伤正,充分保证脾胃运化功能,使精气源源不断转化为元气。
诸药配合,共奏益气养阴,清热解毒,润喉利咽之功。从而达到补元气,健脾益肾润肺而抗疲劳,扶正祛邪,清热解毒而利咽喉的目的。
具体实施方式
以下实施例进一步说明本发明的内容,但不应理解为对本发明的限制。在不背离本发明精神和实质的情况下,对本发明方法、步骤或条件所作的修改或替换,均属于本发明的范围。
实施例1
本实施例中优选的原料为,黄精:Polygonatum sibiricum Red.(北方产区)、枸杞:Lycium barbarum L.、蛹虫草:Cordyceps militaris(L.ex Fr.)Link.、人参:Panaxginseng C.A.Mey.(东北三省产区)、罗汉果:Siraitia grosvenorii(Swingle)C.Jeffrey ex A.M.Lu etZ.Y.Zhang、金银花:Lonicera japonica Thunb.(北方产区)、蒲公英:Taraxacum mongolicum Hand.-Mazz.(北方产区)。按如下重量配比:黄精5克、枸杞5克、蛹虫草2克、人参2克、罗汉果4克、金银花4克、蒲公英5克。
制备本实施例的组合物的方法,包括以下步骤:
(1)按以上配方选取原料,将原料混合,准备进行提取。
(2)10倍水浸泡30min,回流提取90min后,过滤,滤渣再用8倍水回流提取60min后,过滤,合并两次滤液,减压浓缩后冷冻干燥,粉碎后过80目筛备用。
(3)称取75g冻干粉,加入5.8g预胶化淀粉、11.7g微晶纤维素和1g山梨糖醇混合均匀,乙醇作为润湿剂制软材,20目筛制粒,60℃烘箱烘干,过20目筛整粒,加入4.5g薄荷脑、2g硬脂酸镁压片,即得一种清咽缓解体力疲劳组合物。
试验例1:缓解体力疲劳动物实验
100只KM小鼠(雄性)在标准实验环境下自由进食进水,适应性喂养7d后,按体质量随机分为空白对照组、低剂量组、中剂量组、高剂量组和阳性对照组,每组20只。
将实施例1制得的组合物用蒸馏水溶解后配制成不同浓度溶液,除空白对照组灌胃蒸馏水外,各剂量组分别灌胃低、中、高剂量[2.9、5.8、11.6g/(kg·bw)],阳性对照组给予灵芝西洋参口服液[2.6mL/(kg·bw)]。每日灌胃2次,连续灌胃30天,小鼠每隔10天进行适应性游泳训练1次,每次30min,训练时禁止接触池底和池壁并用玻璃棒搅动水面,以避免小鼠漂浮偷懒。
采用SPSS 20.0软件进行单因素方差分析(Analysisof Variance,ANOVA),S表示方差,P表示显著性,对P<0.05的数据用多个实验组和一个对照组间均数的两两比较方法进行统计处理。方差不齐时先进行变量转换,仍不齐则改用秩和检验分析。
1.1.力竭游泳实验
实验第30日,灌胃30min后,各组小鼠随机取10只,每组小鼠尾部负荷质量为体重5%的铅皮,使其在水深约30cm、水温为(25±1)℃的游泳箱中进行负重游泳,观察并用记录小鼠鼻尖持续没入水下9s未浮出的时间,即小鼠负重力竭游泳时间,实验结果见下表。
表1对小鼠力竭游泳时间的影响(±S,n=10)
注:与空白对照相比,*表示差异显著P<0.05,**表示差异极显著P<0.01,下同。
如表1可知,与空白对照组相比,所述组合物可以极显著延长力竭游泳时间(P<0.01),且游泳时间与灌胃剂量成正比。
1.2疲劳相关生化指标测定
实验第30日,灌胃30min后,各组剩余的一半小鼠置于游泳箱内进行90min无负重游泳,取出擦净休息30min后,摘眼球取血,血液室温下静置20min,4500r/min离心15min,取上清液。
各组小鼠取血后立即解剖,取肝脏与腓肠肌,生理盐水漂洗,滤纸吸干。按试剂盒使用说明,测定各组小鼠运动后体内肌糖原(MG)和肝糖原(LG)含量。测定结果见表2。
表2对肌糖原、肝糖原的影响(±S,n=10)
中、高剂量组MG含量显著高于空白对照组(p<0.05);高剂量组LG含量极显著高于空白对照组(p<0.01)。表明所述组合物可能通过增加肝脏和肌肉糖原储备或减少运动期间的消耗来延缓疲劳。
用所述上清液,按试剂盒说明书检测各组小鼠运动后体内乳酸(LA)、血尿素氮(BUN)的含量和乳酸脱氢酶(LDH)、肌酸激酶(CK)活力,测定结果见表3-4。
表3对BUN和CK的影响
低、中、高剂量组BUN含量极显著低于空白对照组(p<0.01);中、高剂量组CK含量极显著低于空白对照组(p<0.01)。表明所述组合物可能通过维持血尿素氮和肌酸激酶的含量稳定延缓疲劳。
表4对LA和LDH的影响
低、中、高剂量组LA含量极显著低于空白对照组(p<0.01);中、高剂量组LDH含量极显著高于空白对照组(p<0.01)。表明所述组合物可能通过提高乳酸脱氢酶含量加快乳酸分解延缓疲劳。
试验例2:清咽功能实验研究
2.1实验分组及处理
选用健康雄性SD大鼠80只及ICR小鼠40只,分批按体重随机各分为4组(对照组和低、中、高剂量组),每组10只。
SD大鼠:经口灌胃,按照低、中、高剂量每天给予大鼠[0.4、0.8、1.6g/(kg·bw)](分别相当于成人每日每千克体重推荐摄入量的5倍、10倍和20倍)所述组合物,大鼠灌胃容积为10mL/kg·bw,空白对照组以等容积纯净水灌胃,每日灌胃1次。
ICR小鼠:经口灌胃,按照低、中、高剂量每天给予小鼠[2.8、5.6、11.2g/(kg·bw)](分别相当于成人每日每千克体重推荐摄入量的5倍、10倍和20倍)所述组合物,小鼠灌胃容积为20mL/kg·bw,空白对照组以等容积纯净水灌胃,每日灌胃2次。
共分3批分别进行大鼠棉球植入实验、大鼠足趾肿胀实验及小鼠耳肿胀实验。各组实验动物均给以普通饲料,自由进食和饮水,连续灌胃30天后检测各项指标。
2.2.数据处理
采用SPSS 20.0软件进行单因素方差分析(Analysisof Variance,ANOVA),S表示方差,P表示显著性,对P<0.05的数据用多个实验组和一个对照组间均数的两两比较方法进行统计处理。方差不齐时先进行变量转换,仍不齐则改用秩和检验分析。
2.3.大鼠棉球植入实验
实验结束前8天,用脱毛器脱去大鼠两侧腹股沟处的毛,乙醚浅麻醉,碘伏消毒,在无菌条件下切开大鼠两侧腹股沟皮肤,植入备用的棉球,缝合切口,继续给予所述组合物。实验结束当天,给受试物1h后,断颈处死大鼠,在原缝合处剪开皮肤,剥离并取出棉球肉芽组织,置于已称重洁净平皿中,恒温干燥箱60℃开盖干燥1h后称重,计算肉芽肿净重,结果见表5。
肉芽肿净重/mg=干燥后棉球肉芽肿质量-原棉球质量
表5大鼠棉球植入实验结果(±S)
注:与对照组比较,*P<0.05。
各剂量组肉芽肿净重均低于对照组,经方差分析及两两比较,与阴性对照组比较,中、高剂量组肉芽肿净量显著降低,差异有统计学意义(P<0.05),该项实验结果阳性。
2.4.大鼠足趾肿胀实验
实验结束当天再给所述组合物一次。1小时后,用足趾容积测量仪测量各组大鼠右后足趾的容积,作为0小时足趾容积。然后在大鼠右后足趾皮下注入1%葡聚糖4万0.1mL/只,分别于1、2、4、6h测量大鼠足趾的容积,同一部位测量3次,取平均值。以不同时间所测足趾容积与致炎剂作用前的足趾容积之差为肿胀值,计算各个时间段的足趾肿胀率,结果见表6。
足趾肿胀率/%=肿胀值/致炎前足趾容积×100%
表6大鼠足趾肿胀实验结果(±S,n=10)
注:与对照组比较,*P<0.05。
与阴性对照组比较,高剂量组大鼠1h、2h,中剂量组2h,足趾肿胀率明显降低,差异有统计学意义(P<0.05)。
2.5.小鼠耳肿胀实验
汲取二甲苯20μL,滴加在小鼠右耳外侧面耳廓的中央,让其自由扩散,30min后,将小鼠脱颈椎处死,剪下双耳,用9mm直径打孔器在两耳相同部位打下耳片称重,以两耳重量之差为耳廓肿胀值,计算耳廓肿胀率,结果见表7。
耳廓肿胀率%=耳廓肿胀值/对照耳片质量×100%
表7小鼠耳肿胀实验结果(±S)
注:与对照组比较,*P<0.05,**P<0.01。
所述组合物各剂量耳廓肿胀率均低于对照组,经方差分析及两两比较,与阴性对照组比较,所述组合物高剂量组小鼠耳廓肿胀率明显降低,差异有统计学意义(P<0.01)。
2.6结果分析
实验期间各组大鼠一般状况良好,无异常症状和体征,无死亡和行为异常。
各项实验前后动物生长情况良好,所述组合物的各剂量组与溶剂对照组动物体重和增重差异均无统计学意义(P>0.05)。
本试验例的结果证明,使用实施例1制备的组合物干预后,与空白对照组相比,SD大鼠中、高剂量组肉芽肿净量显著降低,差异有统计学意义(P<0.05);高剂量组大鼠1h、2h,中剂量组2h,足趾肿胀率明显降低,差异有统计学意义(P<0.05)。ICR小鼠高剂量组耳廓肿胀率低于溶剂对照组。说明所述组合物具有干预大鼠肉芽肿形成、足趾肿胀以及抑制小鼠耳廓肿胀的作用。以上3个实验结果均为阳性,可判定所述组合物清咽功能实验结果阳性,说明所述组合物具有清咽的作用。
对照例1
本对照例中与实施例1不同之处在于,在实施例1原料基础上减少药材罗汉果、金银花,其他技术方案完全相同。采用试验例1中的试验方法进行缓解体力疲劳动物实验。试验结果见下表:
表8对小鼠力竭游泳时间的影响(±S,n=10)
注:与空白对照相比,*表示差异显著P<0.05,**表示差异极显著P<0.01,下同。
表9对肌糖原、肝糖原的影响(±S,n=10)
表10对BUN和CK的影响
表11对LA和LDH的影响
本对照例的试验结果证实,缺少罗汉果、金银花后并不能取得与实施例1完全相同的抗疲劳效果。
虽然,上文中已经用一般性说明、具体实施方式及试验,对本发明作了详尽的描述,但在本发明基础上,可以对其作一些修改或改进,这对本领域技术人员而言是显而易见的。因此,在不偏离本发明精神的基础上所做的这些修改或改进,均属于本发明要求保护的范围。
Claims (10)
1.一种清咽缓解体力疲劳组合物,其特征在于,制备所述组合物的原料包括按如下重量配比的:黄精5-8份、枸杞5-8份、蛹虫草2-3份、人参2-3份、罗汉果4-6份、金银花4-5份、蒲公英4-6份。
2.根据权利要求1所述的组合物,其特征在于,制备所述组合物的原料包括按如下重量配比的:黄精5份、枸杞5份、蛹虫草2份、人参2份、罗汉果4份、金银花4份、蒲公英5份。
3.根据权利要求1所述的组合物,其特征在于,制备所述组合物的原料还包括药学或保健品中可接受的辅料。
4.根据权利要求3所述的组合物,其特征在于,所述辅料包括粘合剂、矫味剂、助流剂、润滑剂的一种或多种。
5.根据权利要求4所述的组合物,其特征在于,所述辅料包括胶化淀粉、微晶纤维素、山梨糖醇、乙醇、薄荷脑、硬脂酸镁。
6.根据权利要求5所述的组合物,其特征在于,所述的组合物可制成片剂、口服液、颗粒剂、胶囊等剂型中的任一种。
7.根据权利要求1所述的组合物,其特征在于,所述的组合物在制备缓解体力疲劳药品或保健品中的应用。
8.根据权利要求1所述的组合物,其特征在于,所述的组合物在制备清咽药品或保健品中的应用。
9.一种缓解体力疲劳的药品,其特征在于,所述药品由权利要求1-8中的任意一项所述组合物制备。
10.一种清咽的药品,其特征在于,所述药品由权利要求1-8中的任意一项所述的组合物。
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