CN110074243A - 一种具有解酒和保护肝脏功能的压片糖果 - Google Patents
一种具有解酒和保护肝脏功能的压片糖果 Download PDFInfo
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Abstract
本发明公开了一种具有解酒和保护肝脏功能的压片糖果,主成分为葛根粉或提取物、山楂粉或提取物、茯苓粉或提取物、决明子粉或提取物、枳椇子粉或提取物、菊花粉或提取物,还包括木糖醇,包括或者不包括微晶纤维素、硬脂酸镁等组分。本发明将葛根、山楂、茯苓、决明子、枳椇子、菊花联合使用,不仅对肝脏有辅助保护作用,还具有促进酒精分解、降低酒精对肝的损伤、酒后降低大脑深度痛感、减少酒后胃部不适的特点。
Description
技术领域
本发明属于保健食品技术领域,具体为一种促进酒精分解,降低酒精对肝的损伤,降低酒后大脑深度痛感,减少酒后胃部不适,保护肝脏的压片糖果。
背景技术
随着生活水平的提高、饮食结构的变化和酒精消费的日益增长,酒精性肝病的发病率在世界范围内呈逐年升高的趋势。过度饮酒、醉酒对人体健康造成极大危害,如:脂肪肝、胃溃疡、胃出血、周边神经病变、大脑皮质萎缩、心肌变性、智力衰退等。近年来病毒性肝炎、脂肪肝、酒精性肝病已经成为威胁人类健康的重要疾病,由长期饮酒、饮酒过量引起的酒精性肝病已经成为仅次于病毒性肝炎的肝脏第二大杀手。重度饮酒者中80%以上有一定程度的脂肪肝,10%-35%可能发展成酒精性肝炎,10%-20%将发展成肝硬化,且酒精性肝硬化愈后较差,5年生存率约为23%-50%。有调查指出,我国酒精性肝病在所有肝病中的比例逐年增加,目前对酒精性肝病尚无特效治疗药物。
因此,本领域迫切需要一种涉及保护肝脏的食品,具体能够促进酒精分解、降低酒精对肝的损伤、降低酒后大脑深度痛感、减少酒后胃部不适、保护肝脏的保健食品。
发明内容
本发明所要解决的技术问题在于针对上述现有的技术不足,提供一种具有解酒和保护肝脏功能的压片糖果。
本发明提供的压片糖果,其主成分为葛根粉或提取物、山楂粉或提取物、茯苓粉或提取物、决明子粉或提取物、枳椇子粉或提取物、菊花粉或提取物中的一种或几种,还包括木糖醇,包括或者不包括微晶纤维素、硬脂酸镁等组分。
本发明提供的压片糖果,其各个组分的重量百分比如下:
葛根粉或提取物8.74~41.28%,山楂粉或提取物6.37~37.15%,枳椇子粉或提取物 11.35~46.72%,茯苓粉或提取物1.33~8.64%,决明子粉或提取物4.22~24.37%,菊花粉或提取物3.62~25.81%,木糖醇2.25~15.34%,微晶纤维素1.45~10.72%,硬脂酸镁0.1~2.5%。
作为本发明一优选实施方案,本发明提供的压片糖果,其各个组分的重量百分比如下:
葛根粉或提取物12.17~33.26%,山楂粉或提取物11.42~30.25%,枳椇子粉或提取物 15.86~37.38%,茯苓粉或提取物3.34~7.12%,决明子粉或提取物6.63~15.74%,菊花粉或提取物8.71~20.28%,木糖醇5.36~12.82%,微晶纤维素2.66~8.41%,硬脂酸镁0.5~2.0%。
较佳地,本发明提供的压片糖果,其各个组分的重量百分比如下:
葛根粉或提取物16.7%,山楂粉或提取物16.7%,枳椇子粉或提取物25%,茯苓粉或提取物5.8%,决明子粉或提取物11.7%,菊花粉或提取物10%,木糖醇8.3%,微晶纤维素4.7%,硬脂酸镁1.2%。
葛根为豆科植物野葛或甘葛藤的干燥根,是中医处方常用的一味具有解肌退热、透发麻疹、生津止渴等功效的药物。葛根成分复杂,其中葛根黄酮成分较高,葛根素是葛根黄酮中的主要化合物。近年来研究表明,葛根能提高肝细胞的再生,恢复正常肝脏机能,促进胆汁分泌,防止脂肪在肝脏堆积,促进新陈代谢,加强肝脏解毒功能,防止酒精对肝脏的损伤。
山楂粉或提取物为蔷薇科植物山里红或山楂的干燥成熟果实提取的棕黄色粉末物质,能促进胃中消化酶的分泌,所含脂肪酶可促进脂肪的分解消化;含多种有机酸、维生素C可提高胃蛋白酶活性,促进蛋白的消化。山楂提取物对胃肠功能具有一定调节作用,对活动亢进的兔十二指肠平滑肌呈抑制作用,而对松弛的大鼠胃平滑肌有轻度的增加收缩作用。
枳椇子是枳椇、北枳椇和毛果枳椇以及它们的变种的成熟种子或具有花序轴的果实,具有解酒止呕、止渴除烦、通利二便的功效。枳椇子解酒保肝作用显著,现有醪立清口服液、解酒保肝口服液、防醉胶囊等中成药制剂应用于临床。文献报道黄酮类化合物是枳椇子中的有效成分,韩国学者报道枳椇子提取物及枳椇子中的hovenodulinol(二氢黄酮醇类化合物)具有解酒毒的作用;日本学者报道枳椇子中的hovenitinⅠ(二氢黄酮醇类化合物)、二氢杨梅素(二氢黄酮醇类化合物)具有保肝的活性。
茯苓属一年生或多年生真菌。古名茯灵、茯兔。别名松薯、松苓、松桕芓等以菌核入药。茯苓提取物主要成分为三萜和多糖,具有健脾、安神、利水渗湿等功效。用于脾虚食少、水肿尿少等的治疗。现代药理学研究表明茯苓具有抑制脾瘤生长、增强机体免疫等多方面的药理作用。苓素是新的醛固酮受体拮抗剂,有利于尿液排出,恢复肾功能。茯苓三萜化合物使胰岛素的分化诱导活性增强,三萜化合物本身也有分化诱导活性。
菊花粉或提取物以菊科植物菊花的干燥头状花序为原料提取,主要活性成分为黄酮类和酚类化合物。具有扩张冠状动脉、降低血压、预防高血脂、抗菌、抗病毒抗炎、抗衰老等多种生理活性。
决明子为豆科植物决明或小决明的成熟种子。味苦而性凉,具有清肝火、祛风湿、益肾明目等功能,是我国第一批药食同源的中药材之一。研究表明,决明子提取物降压作用明显,使血清总胆固醇下降、高密度脂蛋白胆固醇升高。决明子能产生扩血管作用,因而可以产生降压作用。中药决明子提取物对四氯化碳、D-氨基半乳糖、酒精引起的肝损伤,非酒精性脂肪肝致肝损伤有治疗或保护作用。
本发明还提供了一种压片糖果的制备方法,具体如下:
(1)木糖醇过60目筛,备用。
(2)混合:将上述处方量的原辅料混合,过60目筛一遍,置于湿法制粒机中,开启低速搅拌,低速剪切,混合2分钟。
(3)制粒:采用90%乙醇作为润湿剂,过20目尼龙筛制粒,60℃干燥。
(4)整粒:颗粒干燥后采用20目尼龙筛整粒。
(5)总混:将整粒后的颗粒与硬脂酸镁混匀。
(6)压片。
本发明还提供了一种压片糖果在制备用于解酒和保护肝脏食品、保健品或药品中的应用。本发明制备的压片糖果通过饮酒人群服用和市售解酒护肝产品进行对比,在促进酒精分解、降低酒精对肝的损伤效果显著,明显好于市售产品。
本发明的优点在于:结合目前解酒护肝产品存在的缺陷,创造性的将葛根、山楂、茯苓、决明子、枳梖子、菊花联合使用,不仅对肝脏有保护作用,还具有抑制酒后头痛和胃部不适的特点。
本发明全方位、多途径解酒护肝组方成分中即包含了解酒、促进酒精代谢成分,又加入了醉酒和酒精中毒后加速恢复的成分。同时考虑到饮酒者肝脏受损的因素,在组方中还加入了保肝护肝成分。本发明全方位、多途径解酒护肝,其药理作用显著。
本发明采用与其它解酒药不同的作用机制,本发明在解酒时不伤肝,还能有效保护肝脏。通过动物实验和临床实验结果表明,本发明解酒护肝效果良好。
具体实施方式
实施例1压片糖果的制备
处方(1000片):
制备过程:
(1)木糖醇过60目筛,备用。
(2)混合:将上述处方量的原辅料混合,过60目筛一遍,置于湿法制粒机中,开启低速搅拌,低速剪切,混合2分钟。
(3)制粒:采用90%乙醇作为润湿剂,过20目尼龙筛制粒,60℃干燥。
(4)整粒:颗粒干燥后采用20目尼龙筛整粒。
(5)总混:将整粒后的颗粒与硬脂酸镁混匀。
(6)压片。采用椭圆形冲,长轴17mm,短轴8.5mm,进行压片。控制:片重0.60g,硬度5~7kg,片重差异±4%。
实施例2压片糖果的制备
处方(1000片):
制备过程:
(1)木糖醇过60目筛,备用。
(2)混合:将上述处方量的原辅料混合,过60目筛一遍,置于湿法制粒机中,开启低速搅拌,低速剪切,混合2分钟。
(3)制粒:采用90%乙醇作为润湿剂,过20目尼龙筛制粒,60℃干燥。
(4)整粒:颗粒干燥后采用20目尼龙筛整粒。
(5)总混:将整粒后的颗粒与硬脂酸镁混匀。
(6)压片。采用椭圆形冲,长轴17mm,短轴8.5mm,进行压片。控制:片重0.60g,硬度5~7kg,片重差异±4%(576~624mg)。
实施例3压片糖果的制备
处方(1000片):
制备过程:
(1)木糖醇过60目筛,备用。
(2)混合:将上述处方量的原辅料混合,过60目筛一遍,置于湿法制粒机中,开启低速搅拌,低速剪切,混合2分钟。
(3)制粒:采用90%乙醇作为润湿剂,过20目尼龙筛制粒,60℃干燥。
(4)整粒:颗粒干燥后采用20目尼龙筛整粒。
(5)总混:将整粒后的颗粒与硬脂酸镁混匀。
(6)压片。采用椭圆形冲,长轴17mm,短轴8.5mm,进行压片。控制:片重0.60g,硬度5~7kg,片重差异±4%(576~624mg)。
对比例1 市售解酒产品 葛根咀嚼片(净含量:0.5g x4粒x 2袋)产地:武汉
对比例2 市售解酒产品 玉米低聚肽姜黄压片糖果(净含量:72g)产地:天津
以下通过试验例证明本发明的有益效果
试验例1对大鼠酒后不同时间血液中乙醇分解的影响
30只SD大鼠雌雄各半随机分为5组,每组6只,即对比例1、对比例2、实施例1、实施例2和实施例3,分别以1.0mL/100g灌胃50%浓度乙醇,连续灌酒8d。
实验灌胃50%浓度乙醇前30min灌胃给药,给药剂量按人拟用推荐剂量折算(人拟用剂量为2.8g/d,人按70kg体重计,按人体推荐摄入量的5倍折算),灌胃0.2g/kg受试物,给药量为1.0mL/100g,连续给药8d。
于最后一天灌酒后30、60、90、120、180min后对各组动物眼眶后静脉丛取血约0.4mL,置于肝素钠处理过的EP管中,并用封口胶密封,4℃保存。其中取200μL血样于顶空进样瓶中,加入100μL正丁醇(浓度为4μL/mL)作内标,加盖密封后采用顶空气相色谱法(HS-GC) 测定血液中乙醇浓度。
结果:对大鼠酒后不同时间血液乙醇浓度的影响如表1。
表1各组大鼠酒后血液乙醇浓度变化的情况(mg/mL)
各组大鼠的血液乙醇浓度变化:对比例组的大鼠血液乙醇浓度均明显高于实施例组,说明该发明中压片糖果通过促进乙醇的分解,减少乙醇在体内的吸收,从而避免过多的乙醇进入血液循环。实施例1、2、3组酒后30、60、90、120、180min血液乙醇浓度均显著低于对比例组1、2。结果表明该发明可促进酒精分解,降低大鼠酒后血液中乙醇浓度,减少急性酒精中毒风险。(见表1)
试验例2对酒精性肝损伤大鼠的动物实验影响
模型建立:取Wistar大鼠30只随机分为5组:
正常对照组:给予生理盐水灌胃12d;模型组:酒精-玉米油-吡唑混合液(50°食用酒精5g/kg 、玉米油2ml/kg、吡唑27.2mg/kg)每日灌胃造模12d;实验组包括实施例1、2、3组:除每天酒精-玉米油-吡唑混合液灌胃外,每天中午12:00灌胃产品1mL/100g。12d后处死大鼠,取肝脏及心脏取血。
谷丙转氨酶(ALT)、谷草转氨酶(AST)、超氧化物歧化酶(SOD)、丙二醛(MDA)含量的检测:心脏取血提取血清,应用试剂盒检测ALT、AST含量;取大鼠肝脏,用4℃0.9%生理盐水冲洗后制备成10%的肝匀浆,测定SOD活性(采用黄嘌呤氧化酶法),测定MDA的含量 (硫代巴比妥酸比色法)。
表2对ALD大鼠血清ALT、AST和肝脏MDA含量及SOD活性的影响(x±s,n=6)
A表示该组与正常组对比P<0.05,显著;b表示该组与模型组对比P<0.05显著
与正常对照组大鼠相比,模型组大鼠血清ALT、AST含量显著升高(P<0.05)。与模型组大鼠相比,实施例1、2、3组大鼠血清中的ALT、AST含量降低(P<0.05)。与正常对照组大鼠相比,模型组大鼠的MDA的含量升高显著,同时SOD的活性明显降低(P<0.05)。与模型组相比,实施例1,2,3大鼠肝匀浆MDA含量降低,SOD活性升高(P<0.05)。结果表明,该发明可以降低酒精对肝的损伤,有保肝护肝作用。
试验例3对酒后降低大脑深度痛感,减少胃部不适的影响
本实施组以实施例1、2、3制备的产品,用法用量为酒前或酒后服用,每次4片。
对照组按照对比例1和对比例2的市售压片糖果,用法用量按照市售产品食用方法和食用量,对比例1用法用量为酒前或酒后服用,每次4粒;对比例2用法用量为酒前或酒后服用,每次4粒。
一般临床资料:临床观察醉后病例共180例,观察时间6小时。治疗组90例(包括实施例1、2、3,共三组,每组30例),对照组60例(包括对照组1、2,共两组,每组30例),全白组30例。治疗组、对照组服用相应压片糖果,空白组服用温开水。疗效比较结果见下表:
疗效判定标准:
治愈:无大脑深度痛感症状,无胃部不适现象;
有效:大脑深度痛感症状减轻或胃部不适现象减轻;
无效:症状无变化。
表3实施组与对照组疗效对比
如表3所示:治疗组中服用实施例1中30例,治愈18例,占60%,总有效率100%;治疗组中实施例2中30例,治愈18例,占60%,总有效率100%;治疗组中实施例3中30 例,治愈28例,占93%,总有效率100%;对照组中服用对比例1中市售压片糖果30例,治愈12,占40%,总有效率80%;对照组服用对比例2中市售压片糖果30例,治愈5例,占17%,总有效例70%,无效1例;空白组30例,服用温开水治愈0例,有效2例,无效 28例,总有效率7%,结果表明:实施例、对照例均能有效降低大脑深度痛感,减少胃部不适,本发明产品效果更佳。
试验例4对改善肝功能、保肝护肝效果的影响
试食纳入标准
①年龄3865岁。②长期饮酒史,乙醇量:男性40g/d,女性20g/d或2周内有大量饮酒史 80g/d。③临床表现缺乏特异性,可有乏力、体重下降、肝区隐痛等非特异性症状及体征;病情加重者可出现肝硬化体征。④AST、ALT、GGT、TBil、PT和MCV可有升高。⑤肝脏影像学表现较为典型。凡具备以上第1、2、5项,以及第3或第4项中任何一项者即可诊断为酒精性肝病。
试食排除标准
①病毒性肝炎、药物及中毒性肝损伤。②已接受相关治疗并可能影响效应观测指标。③伴有可能影响效应指标观测、判断的其他生理或病理状况。④严重心、肝、肾损害影响药物代谢。⑤特征人群(孕妇、婴幼儿、未成年人、高龄、精神病、病情危笃或疾病晚期)。
试食退出标准
①按规定服药无法判断疗效。②资料不全无法判定疗效、安全性。③严重不良反应、并发症、特殊生理变化等,难以继续治疗(不良反应者纳入不良反应统计)。④使用影响试食药物。退出按退出时疗效纳入疗效判定。
试食方法
饮酒前服用4粒,酒后再服用4粒,无饮酒情况,4粒/次,3次/d,14天为一疗程。连续治疗5疗程(70d),判定疗效。
试食疗效判定
显效:症状和体征消失或明显改善,肝功能指标恢复正常,但r-GT仍有轻度升高<100。好转:症状和体征有所改善,肝功能指标(T-Bil、ALT、AST、r-GT)较治疗前数值均下降> 50%。无效:症状和体征无改善,其各项指标未达好转标准。
选取240例,男175例,女65例,均有长期酗酒史,饮酒年限为535年,平均年限为15.5,全部符合试食标准,随机平均分成5组,每组48例,按试食方法试食实施例1、实施例2、
实施例3、对比例1、对比例2的产品,食用5疗程。试食期间无退出情况。
比较结果如下:
表4实施组与对照组保肝护肝疗效对比
实验结果表明,实施组与对照组对酒精性肝病症状、体征具有一定改善作用。实施组产品疗效优于对照组,说明本发明压片糖果具有保肝护肝的作用,对改善肝功能效果明显,优于上述市售产品。
前述对本发明的具体示例性实施方案的描述是为了说明和例证的目的。这些描述并非想将本发明限定为所公开的精确形试,并且很显然,根据上述教导,可以进行很多改变和变化对示例性实施例进行选择和描述的目的在于解释本发明的特定原理及其实际应用,从而使得本领域的技术人员能够实现并利用本发明的各种不同的示例性实施方案以及各种不同的选择和改变本发明的范围意在由权利要求书及其等同形式所限定。
Claims (5)
1.一种压片糖果,其特征在于主成分为葛根粉或提取物、山楂粉或提取物、茯苓粉或提取物、决明子粉或提取物、枳椇子粉或提取物、菊花粉或提取物中的一种或几种。
2.根据权利要求1所述的压片糖果,其特征在于还包括木糖醇,包括或者不包括微晶纤维素、硬脂酸镁等组分。
3.根据权利要求1-2任一项所述的压片糖果,其特征在于各个组分的重量百分比如下:
葛根粉或提取物8.74~41.28%,山楂粉或提取物6.37~37.15%,枳椇子粉或提取物11.35~46.72%,茯苓粉或提取物1.33~8.64%,决明子粉或提取物4.22~24.37%,菊花粉或提取物3.62~25.81%,木糖醇2.25~15.34%,微晶纤维素1.45~10.72%,硬脂酸镁0.1~2.5%。
4.根据权利要求1-3任一项所述的压片糖果,其特征在于各个组分的重量百分比如下:
葛根粉或提取物12.17~33.26%,山楂粉或提取物11.42~30.25%,枳椇子粉或提取物15.86~37.38%,茯苓粉或提取物3.34~7.12%,决明子粉或提取物6.63~15.74%,菊花粉或提取物8.71~20.28%,木糖醇5.36~12.82%,微晶纤维素2.66~8.41%,硬脂酸镁0.5~2.0%。
5.根据权利要求1-4任一项所述的压片糖果在制备用于促进酒精分解、降低酒精对肝的损伤、酒后降低大脑深度痛感、减少酒后胃部不适、保护肝脏的食品、保健品或药品中的应用。
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