CN116173076A - 一种护肝解酒的组合物及其应用 - Google Patents
一种护肝解酒的组合物及其应用 Download PDFInfo
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Abstract
本发明涉及一种护肝解酒的组合物及其应用,该组合物包括青春双歧杆菌、植物乳杆菌、鼠李糖乳杆菌、水苏糖和2’‑岩藻糖基乳糖。本发明组合物可以大大缓解酒后的肠道菌群失调、肝脏损伤,从而改善胃肠不适、腹泻、恶心嗳气、头痛、失眠等症状。
Description
技术领域
本发明属于保健品技术领域,具体涉及一种护肝解酒的组合物及其应用。
背景技术
随着经济水平的提升和国内酒产业的发展,酗酒或酒精滥用人数逐年增加,酒精性肝病人数剧增,酒精性肝病包括脂肪肝、酒精性肝炎、肝纤维化和肝硬化,甚至可能恶化后的肝癌。
酒精会对多个末端器官造成损伤,主要是肝脏、肠道和大脑。研究酒精带来的损伤进展过程中的肠道微生物环境是一个相关的目标。
描述肠道微生物组成变化的一个术语是“微生物失调”,粗略定义为微生物群的失衡或改变,可能对宿主产生不利影响。肠道菌群的改变在各种疾病中都有描述,如肝硬化、炎症性肠病(IBD)、帕金森病、孤独症和艰难梭菌感染。
肠-肝轴是酒精性肝病发生发展的主要途径。这条肠-肝轴与肠道免疫反应、肠屏障功能、肝脏和全身炎症有关,在酒精性肝病期间会被严重破坏。
肠屏障是肠-肝轴的重要组成部分,在啮齿类动物研究中,肠道微生物通过肠道缺氧诱导因子1α活性和表达的特异性降低影响酒精相关的肠道通透性变化,这种变化可被益生菌鼠李糖乳杆菌(LGG)治疗,并通过调节饱和和不饱和脂肪摄入逆转。缺氧诱导因子1α在酒精相关性肝脂肪变性的发生中也很重要。酒精还与产生内毒素的肠杆菌丰度相对增加和产生短链脂肪酸(SCFAs)的类群(如毛螺菌科和瘤胃球菌科)减少相关。
越来越多的证据证明肠道微生物的调整可以对酒精性疾病的治疗以及对于饮酒后的恢复有有益的效果。研究表明,在小鼠模型中,给予嗜黏蛋白阿克曼菌(A.muciniphila)和LGG改善了酒精通过复杂的肠屏障改变和***性炎症诱导的损伤。另有研究表明,在因酒精治疗住院的患者中,给予益生菌5日(两歧双歧杆菌和植物乳杆菌8P-A3)可提高双歧杆菌和乳杆菌等潜在有益细菌的水平。与此同时,轻度酒精性肝炎患者的肝脏相关酶(丙氨酸氨基转移酶、天冬氨酸氨基转移酶和γ-谷氨酰转肽酶)水平也有所改善。
母乳低聚糖(HMOs)是天然存在于人乳中的一类由单糖分子组成的低聚糖,具有一定的甜度但比较低,大约只有蔗糖的30-50%。在人乳固体组分中的含量较高,仅次于乳糖和脂肪,尤其是在初乳中可达22-23g/L,但在婴儿出生后几个月的时间内,其浓度将会稳定下降,在成熟乳中的含量将降至约12-13g/L。其中2’-岩藻糖基乳糖是所有HMOs中含量最丰富的。
HMOs有以下几种生物学功能,最重要的是可以维护肠道的微生态平衡。由于HMOs不被人体的胃酸破坏,也不被消化酶分解,能直接达到大肠,刺激肠道中的有益菌群(双歧杆菌和乳杆菌)生长,间接抑制有害菌群生长,维持肠道微生态平衡,因此,HMOs被看成是人类第1益生元(prebiotics)。母乳喂养的婴幼儿肠道内双歧杆菌的数量明显比配方食品喂养的婴幼儿多,原因是 HMOs能刺激部分双歧杆菌的生长。HMOs其他的生物学功能还有抵御病原菌感染、调节免疫、抑制炎症反应、促进大脑发育等。
现有的治疗酒精中毒或者快速醒酒的药品中有美他多辛、纳洛酮、阿坎酸和托吡酯等,这些药品有一些解酒效果,但是存在诸多的不良反应。比如,美他多辛是乙醛脱氢酶激活剂,可拮抗急、慢性酒精中毒引起的乙醇脱氢酶活性下降,加速乙醇及其代谢产物乙醛和酮体经尿液***。在健康志愿者中,美他多辛可以让乙醇代谢的半衰期从7小时15分钟缩短至5小时50分钟。需要特别注意的是,美他多辛可能会引起周围神经疾病。纳洛酮是阿片类药物过量的解毒剂,也能解除酒精的中枢抑制、缩短昏迷时间,但可能造成精神狂躁的副作用。
国内很多解酒产品的成分大多为葛根、枳椇子、姜黄、刺梨粉、菊粉等等,这些产品存在一定的解酒功能。以上的物质大都为中医中常用的物质,成分比较复杂,可能是依靠物质中的某一种成分带来的效果,比如葛根中所含的葛根异黄酮等生物活性物质通过提高肝脏乙醇脱氢酶和乙醛脱氢酶的活性,清除乙醇及其代谢产物。枳椇子所含的过氧酶类等活性成分具有醒酒安神作用。
现有技术中也有一些益生元和益生菌的组合物或者固体饮料既能调节肠道,又能保护肝脏。但是使用的益生菌菌株种类和用量、益生元的种类和用量均存在差异性。目前为止,还未有将2’-岩藻糖基乳糖和益生元、益生菌联合使用用于缓解醉酒、保护肝脏、酒后恢复的配方和研究。
发明内容
本发明所要解决的技术问题是克服现有技术中的不足,提供一种护肝解酒的组合物及其应用,可以大大缓解酒后的肠道菌群失调、肝脏损伤,从而改善胃肠不适、腹泻、恶心嗳气、头痛、失眠等症状。
为解决以上技术问题,本发明采取的技术方案是:
一种护肝解酒的组合物,包括青春双歧杆菌、植物乳杆菌、鼠李糖乳杆菌、水苏糖和2’-岩藻糖基乳糖。
优选地,还包括低聚果糖;
优选地,还包括低聚木糖。
优选地,还包括低聚乳果糖;
优选地,还包括低聚半乳糖;
优选地,还包括大豆低聚糖。
优选地,还包括风味剂;
优选地,风味剂选自水果提取物、植物蛋白风味剂或食用香精;
优选地,水果提取物选自杨桃提取物。
优选地,组合物,以重量份计,包括如下组分:
其中,青春双歧杆菌所含活性菌的数量≥1×1010CFU/份,
植物乳杆菌所含活性菌的数量≥1×1010CFU/份,
鼠李糖乳杆菌所含活性菌的数量≥1×1010CFU/份。
优选地,组合物,以重量份计,包括如下组分:
其中,青春双歧杆菌所含活性菌的数量≥1×1010CFU/份,
植物乳杆菌所含活性菌的数量≥1×1010CFU/份,
鼠李糖乳杆菌所含活性菌的数量≥1×1010CFU/份。
优选地,组合物,以重量份计,包括如下组分:
其中,青春双歧杆菌所含活性菌的数量≥1×1010CFU/份,
植物乳杆菌所含活性菌的数量≥1×1010CFU/份,
鼠李糖乳杆菌所含活性菌的数量≥1×1010CFU/份。
优选地,组合物,以重量份计,包括如下组分:
其中,青春双歧杆菌所含活性菌的数量≥1×1010CFU/份,
植物乳杆菌所含活性菌的数量≥1×1010CFU/份,
鼠李糖乳杆菌所含活性菌的数量≥1×1010CFU/份。
为解决以上技术问题,本发明采取的又一技术方案是:
如上所述的护肝解酒的组合物在用于制备具有护肝解酒效果的产品中的用途,产品为食品组合物或医药组合物。
优选地,医药组合物为口服剂型,口服剂型为粉剂、颗粒剂、片剂、溶液剂或胶囊剂,食品组合物为固体饮料、液体饮料、压片糖果或软糖。
本发明提供2’-岩藻糖基乳糖在制备护肝解酒的药品或食品中的用途。
由于以上技术方案的采用,本发明与现有技术相比具有如下优点:
1、本发明组合物促进胃肠蠕动,抑制小肠细菌的过度生长,促进胃肠内不适物的排出;
2、本发明在胃肠道形成有益菌和低聚糖保护,避免细菌易位;
3、本发明调节肠道菌群,促进有益菌群生长,抑制有害增殖;
4、本发明服用后可以大大缓解酒后的肠道菌群失调、肝脏损伤,从而改善胃肠不适、腹泻、恶心嗳气、头痛、失眠等症状。
具体实施方式
为使本发明的技术方案和有益效果能够更加明显易懂,下面通过列举具体实施例的方式进行详细说明。应理解,这些实施例仅用于说明本发明而不用于限制本发明的范围。
实施例中未注明具体技术或条件者,通常按照本领域内的文献所描述的常规技术或条件,或者按照产品说明书及制造商建议的条件进行。
除非另有指明,各种起始原料和试剂来自市售或者是根据已知的方法合成,市售原料和试剂均不经进一步纯化直接使用,除非另有指明,市售厂家包括但不限于山东中科嘉亿生物工程有限公司、山东百龙创园生物科技股份有限公司、山东龙力生物科技股份有限公司、广州亿宝莱生物科技有限公司、兰州沃特莱斯生物科技有限公司和苏州一兮生物技术有限公司等。实施例中2’-岩藻糖基乳糖的制备方法如公开号为CN112029790A的发明专利申请中所记载。
本发明一种护肝解酒的组合物,包括青春双歧杆菌、植物乳杆菌、鼠李糖乳杆菌、水苏糖和2’-岩藻糖基乳糖。
本发明组合物中,2’-岩藻糖基乳糖能够促进健康肠道菌群。
本发明组合物中,青春双歧杆菌、植物乳杆菌、鼠李糖乳杆菌为一类活菌制剂,具有平衡肠道菌群、抑制潜在致病菌、增加肠黏膜抵抗力的作用,同时利用益生菌还能改善肠道菌群结构。
本发明组合物中,水苏糖具有润肠通便的功效,对人体胃肠道内的双歧杆菌、乳酸杆菌等有益菌群有着极明显的增殖作用,能迅速改善人体消化道内环境,调节微生态菌群平衡。
在某些实施例中,组合物还包括低聚果糖、低聚木糖、低聚乳果糖、低聚半乳糖或大豆低聚糖,这些益生元在胃中会尽可能地在胃粘膜表面形成一层保护膜,避免酒精直接刺激胃壁,同时也减少胃吸收酒精的速度;还可以促进益生菌肠道定植、肠道收敛、降低肠道pH环境,不被大多数的肠道腐败菌利用,但可以促进人体内有益细菌乳杆菌、双歧杆菌的生长繁殖,从而可以抑制腐败菌生长,有助于改善和维持肠道正常功能。
在某些实施例中,组合物还包括风味剂,用于提高组合的风味。
在某些实施例中,风味剂选自水果提取物、植物蛋白风味剂或食用香精。
在某些实施例中,水果提取物为酥梨、脐橙、香蕉、蓝莓、西瓜、苹果、草莓、菠萝、芒果、水蜜桃或榴莲中的一种。
在某些实施例中,植物蛋白风味剂为植物蛋白鸡肉风味剂、植物蛋白鲜虾风味剂或植物蛋白牛肉风味剂中的一种。
在某一具体的实施例中,水果提取物选自杨桃提取物,杨桃中糖类、维生素C及有机酸含量丰富,能迅速补充人体的水分而止渴,并使体内部热或酒毒随小便排出体外;同时,杨桃能够对肝脏起到保护作用,降低血糖。
在某一具体的实施例中,组合物,以重量份计,包括如下组分:
其中,青春双歧杆菌所含活性菌的数量≥1×1010CFU/份,
植物乳杆菌所含活性菌的数量≥1×1010CFU/份,
鼠李糖乳杆菌所含活性菌的数量≥1×1010CFU/份。
在某一具体的实施例中,组合物,以重量份计,包括如下组分:
其中,青春双歧杆菌所含活性菌的数量≥1×1010CFU/份,
植物乳杆菌所含活性菌的数量≥1×1010CFU/份,
鼠李糖乳杆菌所含活性菌的数量≥1×1010CFU/份。
在某一具体的实施例中,组合物,以重量份计,包括如下组分:
其中,青春双歧杆菌所含活性菌的数量≥1×1010CFU/份,
植物乳杆菌所含活性菌的数量≥1×1010CFU/份,
鼠李糖乳杆菌所含活性菌的数量≥1×1010CFU/份。
在某一具体的实施例中,组合物,以重量份计,包括如下组分:
其中,青春双歧杆菌所含活性菌的数量≥1×1010CFU/份,
植物乳杆菌所含活性菌的数量≥1×1010CFU/份,
鼠李糖乳杆菌所含活性菌的数量≥1×1010CFU/份。
在某些实施例中,水苏糖可以为0.4-1.0份,优选为0.6-0.8份,更具体的可以为0.4、0.5、0.6、0.8、1.0、1.2重量份。
在某些实施例中,2’-岩藻糖基乳糖可以为0.03-0.08,优选为0.04-0.07,更具体的可以为0.03、0.04、0.05、0.06、0.07、0.08、1.0重量份。
在某些实施例中,低聚果糖可以为0.6-1.2份,优选为0.8-1.0份,更具体的可以为0.5、0.6、0.7、0.8、0.9、1.0、1.2、1.5重量份。
在某些实施例中,低聚木糖可以为0.6-1.2份,优选为0.8-1.0份,更具体的可以为0.5、0.6、0.7、0.8、0.9、1.0、1.2、1.5重量份。
在某些实施例中,低聚乳果糖更具体的可以为0.2、0.3、0.4、0.5、0.6重量份。
在某些实施例中,低聚半乳糖更具体的可以为0.2、0.3、0.4、0.5、0.6重量份。
在某些实施例中,大豆低聚糖更具体的可以为0.1、0.2、0.3重量份。
在某些实施例中,杨桃提取物更具体的可以为0.1、0.2、0.3重量份。
在某些实施例中,如上所述的护肝解酒的组合物在用于制备具有护肝解酒效果的产品中的用途。
在某些实施例中,具有护肝解酒效果的产品为食品组合物或医药组合物。
在某些实施例中,医药组合物为口服剂型,口服剂型为粉剂、颗粒剂、片剂、溶液剂或胶囊剂,食品组合物为固体饮料、液体饮料、压片糖果或软糖。
本发明提供2’-岩藻糖基乳糖在制备护肝解酒的药品或食品中的用途。
对比例
本实施例护肝解酒的组合物,包括如下组分:
名称 | 重量(g) |
青春双歧杆菌 | 0.4 |
植物乳杆菌 | 0.1 |
鼠李糖乳杆菌 | 0.1 |
低聚果糖 | 0.5 |
低聚木糖 | 0.5 |
水苏糖 | 0.4 |
低聚乳果糖 | 0.2 |
低聚半乳糖 | 0.2 |
大豆低聚糖 | 0.1 |
杨桃提取物 | 0.1 |
上述表格中,青春双歧杆菌的规格为每克所含活性菌的数量≥1×1010CFU,
植物乳杆菌的规格为每克所含活性菌的数量≥1×1010CFU,
鼠李糖乳杆菌的规格为每克所含活性菌的数量≥1×1010CFU。
按照表格中的用量称取各项原料,放入均质机器中混匀。然后,将混合物倒入压片机料斗内,调整机器参数,得符合质量要求的含益生菌的护肝解酒的压片糖果。
实施例1
本实施例护肝解酒的组合物,包括如下组分:
名称 | 重量(g) |
青春双歧杆菌 | 0.4 |
植物乳杆菌 | 0.1 |
鼠李糖乳杆菌 | 0.1 |
低聚果糖 | 0.5 |
低聚木糖 | 0.5 |
水苏糖 | 0.4 |
低聚乳果糖 | 0.2 |
低聚半乳糖 | 0.2 |
大豆低聚糖 | 0.1 |
杨桃提取物 | 0.1 |
2’-岩藻糖基乳糖 | 0.03 |
上述表格中,青春双歧杆菌的规格为每克所含活性菌的数量≥1×1010CFU,
植物乳杆菌的规格为每克所含活性菌的数量≥1×1010CFU,
鼠李糖乳杆菌的规格为每克所含活性菌的数量≥1×1010CFU。
按照表格中的用量称取各项原料,放入均质机器中混匀。然后,将混合物倒入压片机料斗内,调整机器参数,得符合质量要求的含益生菌的护肝解酒的压片糖果。
效果测试
招募受试者,受试者条件要求如下:
1、男女不限,年龄18-70岁;
2、身体质量指数:18.5≤BMI<30.0kg/㎡(计算方法:体重千克数/(身高米数)2);
3、过去六个月持续每周排便次数正常;
4、在参加试验期间可维持正常生活作息、饮食及运动习惯;
5、无器质性肠道疾病;
6、无重大肠胃疾病史;
7、无腹部手术史;
8、无糖尿病病史;
9、自评估日常可承受饮酒量在100ml-200ml之间。
按照上述条件招募受试者50名,进行测试。
将上述受试者随机分成ABCDE五组,每组10名,按照下述步骤进行测试。
A组:
第一次饮酒:不做任何措施,第一天晚餐时饮酒150ml,次日正常工作生活。记录饮酒后状况以及不良反应。
第二次饮酒(1周后):受试者饮酒前60分钟,口服一颗普通压片糖果,不含上述组合物成分,晚餐时饮酒150ml,次日正常工作生活。记录饮酒后状况以及不良反应。
B组:
第一次饮酒:不做任何措施,第一天晚餐时饮酒150ml,次日正常工作生活。记录饮酒后状况以及不良反应。
第二次饮酒(1周后):受试者饮酒前60分钟,口服一颗对比例压片糖果,晚餐时饮酒150ml,次日早晨起床后再次口服一颗对比例压片糖果,正常工作生活,记录饮酒后状况以及不良反应。
C组:
第一次饮酒:不做任何措施,第一天晚餐时饮酒150ml,次日正常工作生活。记录饮酒后状况以及不良反应。
第二次饮酒(1周后):受试者饮酒前60分钟,口服一颗实施例1压片糖果,晚餐时饮酒150ml,次日正常工作生活。记录饮酒后状况以及不良反应。
D组:
第一次饮酒:不做任何措施,第一天晚餐时饮酒150ml,次日正常工作生活。记录饮酒后状况以及不良反应。
第二次饮酒(1周后):受试者晚餐时饮酒150ml,次日早晨起床后口服一颗实施例1压片糖果,正常工作生活,记录饮酒后状况以及不良反应。
E组:
第一次饮酒:不做任何措施,第一天晚餐时饮酒150ml,次日正常工作生活。记录饮酒后状况以及不良反应。
第二次饮酒(1周后):受试者饮酒前60分钟,口服一颗实施例1压片糖果,晚餐时饮酒150ml,次日早晨起床后再次口服一颗实施例1压片糖果,正常工作生活,记录饮酒后状况以及不良反应。
不良反应指肠胃不适、腹泻、便秘、恶心嗳气、头痛、失眠等。
测试结果如表1所示:
表1各组不良反应报告结果
表1说明:
①A组(1)代表A组第一次饮酒后报告的结果,A组(2)代表A组第二次饮酒后报告的结果,其他亦参照此规则。
②A组第一次饮酒后如果有4人报告肠胃不适,即记录A组(1)对应的肠胃不适的报告次数为4,其他亦参照此规则。
③由于每个人可能存在多种不同的不良反应,所以不良反应发生率的计算公式如下:
其中,分母(每组所有不良反应的总数)是指每组10人乘以表1中每人可能发生的所述7种不良反应的积。如A组10人乘以7,即分母为70。
根据上述表1的结果,可以得到如下结论:
1、饮酒后会带来一定程度的不良反应,因人而异;
2、饮酒前口服实施例1压片糖果可以一定程度的控制不良反应的发生率;
3、饮酒后口服实施例1压片糖果可以一定程度的控制不良反应的发生率,效果较饮酒前差;
4、饮酒前后均口服实施例1压片糖果可以有效的控制不良反应的发生率,效果最佳。
5、饮酒前后均口服对比例压片糖果可以一定程度的控制不良反应的发生率,但较实施例1压片糖果效果要差很多。
实施例2
本实施例护肝解酒的组合物,包括如下组分:
名称 | 重量(g) |
青春双歧杆菌 | 0.6 |
植物乳杆菌 | 0.4 |
鼠李糖乳杆菌 | 0.3 |
低聚果糖 | 1.5 |
低聚木糖 | 1.5 |
水苏糖 | 1.2 |
低聚乳果糖 | 0.6 |
低聚半乳糖 | 0.6 |
大豆低聚糖 | 0.3 |
杨桃提取物 | 0.3 |
2’-岩藻糖基乳糖 | 0.1 |
上述表格中,青春双歧杆菌的规格为每克所含活性菌的数量≥1×1010CFU,
植物乳杆菌的规格为每克所含活性菌的数量≥1×1010CFU,
鼠李糖乳杆菌的规格为每克所含活性菌的数量≥1×1010CFU。
按照表格中的用量称取各项原料,置于60℃下干燥数小时,然后过筛网。后续将上述混合物放入均质机器中混匀,装入食用级包装袋中封装。
效果测试
取用上述固体饮料一份,溶解到50ml的纯净水中,搅拌均匀。
取SPF级ICR雌性小鼠(20±5g)共15只,随机分成3组,每组5只,适应性喂养1周后开始实验。
A组(空白对照租):一次经口灌胃给予0.1ml/10g的纯净水,观察小鼠情况;
B组(阴性对照组):一次经口灌胃给予0.1ml/10g的纯净水,等待60分钟后,经口灌胃给予0.3ml/10g(致醉量)的52度白酒,观察小鼠情况,记录醉酒到醒酒的时间;
C组(实验组):一次经口灌胃给予0.1ml/10g的固体饮料(含上述组合物),等待60分钟后,经口灌胃给予0.3ml/10g(致醉量)的52度白酒,观察小鼠情况,记录醉酒到醒酒的时间。
醉酒时间定义为失去翻正反射开始,醒酒时间定义为恢复翻正反射。
24小时后处死动物,取血样,测定血清中谷丙转氨酶(ALT)、谷草转氨酶(AST)含量。
表2小鼠醉酒恢复实验结果
实验结果表明,阴性对照组醉酒时间小于实验组,而醒酒时间远远大于实验组。另外,血清学水平上,阴性对照组的ALT和AST值明显升高,差异有显著性,说明本发明的饮料确实具有护肝解酒的功效。
应当理解,以上实施例均为示例性的,不用于包含权利要求所包含的所有可能的实施方式。在不脱离本公开的范围的情况下,还可以在以上实施例的基础上做出各种变形和改变。同样的,也可以对以上实施例的各个技术特征进行任意组合,以形成可能没有被明确描述的本发明的另外的实施例。因此,上述实施例仅表达了本发明的几种实施方式,不对本发明专利的保护范围进行限制。
Claims (10)
1.一种护肝解酒的组合物,其特征在于:包括青春双歧杆菌、植物乳杆菌、鼠李糖乳杆菌、水苏糖和2’-岩藻糖基乳糖。
2.根据权利要求1所述的护肝解酒的组合物,其特征在于:还包括低聚果糖;
优选地,还包括低聚木糖。
3.根据权利要求1所述的护肝解酒的组合物,其特征在于:还包括低聚乳果糖;
优选地,还包括低聚半乳糖;
优选地,还包括大豆低聚糖。
4.根据权利要求1所述的护肝解酒的组合物,其特征在于:还包括风味剂;
优选地,所述风味剂选自水果提取物、植物蛋白风味剂或食用香精;
优选地,所述水果提取物选自杨桃提取物。
9.如权利要求1-8中任一项所述的护肝解酒的组合物在用于制备具有护肝解酒效果的产品中的用途,所述产品为食品组合物或医药组合物;
优选地,所述医药组合物为口服剂型,所述口服剂型为粉剂、颗粒剂、片剂、溶液剂或胶囊剂,所述食品组合物为固体饮料、液体饮料、压片糖果或软糖。
10.2’-岩藻糖基乳糖在制备护肝解酒的药品或食品中的用途。
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