CN107114781B - 一种用于保肝的保健食品及其制备方法 - Google Patents
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Abstract
本发明提供了一种用于保肝的保健食品,是由山楂、丹参、五味子、黄芪和葛根制备而成。本发明同时提供了制备方法:取五味子、丹参、葛根,加乙醇加热回流提取,合并滤液,浓缩成稠膏;取山楂、黄芪,加水煎煮,合并滤液,浓缩成稠膏,与上述稠膏混合,减压干燥,粉成细粉,乙醇制颗粒,整粒,压片,包薄膜衣。本发明提供的保肝的保健食品具有明显保护肝脏作用,具有活血化积、补气健脾、升清降浊的作用,适用于酒精性肝损伤的人群。可制备成片剂剂型,便于患者的服用和携带。
Description
技术领域
本发明属于中药领域,是以中草药为原料制备的用于保肝的保健食品。
背景技术
酒精性肝病(alcoholic liver disease,ALD)是指由于过量酒精摄入导致的肝脏损害及其一系列病变,在全世界范围内依然成为严重危害公众健康的常见疾病之一,并呈逐年上升趋势。随着我国饮食结构和生活方式的改变,ALD患病率也不断增高,对我国人民身体健康和社会发展构成了严重威胁。其主要临床特征是恶心呕吐、黄疸、肝脏肿大和压痛,严重酗酒时可诱发广泛肝细胞坏死甚至肝功能衰竭和上消化道出血等。大量或一次性过量饮酒,可直接导致急性酒精中毒并严重损害肝脏、肾脏、大脑等人体重要器官。因此,有人将酒精称为“慢性肝毒素”。ALD患者的主要死因是门静脉高压、肝性脑病、腹水、肝肾综合征和食管胃底静脉曲张等。近来有学者发现,ALD患者血小板激活能力增强,较易出现血小板减少,导致出血性疾病。甚至严重ALD患者短期死亡率高达35%以上。
但是ALD的发生发展是一个缓慢而隐匿的过程,往往患者本身不易察觉,一旦出现症状或发现出现肝损伤就已经到了肝功出现异常的状况,应属于酒精性肝炎的阶段。一般来说,ALD包括轻症ALD(mild alcoholic injury,MAI)、酒精性脂肪肝(alcoholic fattyliver,AFL)、酒精性肝炎(alcohol hepatitis,AH)、酒精性肝纤维化(alcoholichepaticfibrosis,AHF)和酒精性肝硬化(alcoholic cirrhosis,AC)等5种类型。酗酒者90%以上易患脂肪肝,10%~35%发展为酒精性肝炎,约有8%~20%的慢性嗜酒者演变为肝硬化,甚至导致肝癌。据估计,1993年美国约有1530万人酗酒,患有酒精性肝病者有200多万人,每年有2.6万人死于肝硬化,其中至少40%或许高达90%的酗酒者有酗酒史。在我国随着我国饮食结构和生活方式的改变,ALD患病率也不断提高。我国目前ALD的发病率较20世纪80年代前增加了30倍,发病患者群仅次于病毒性肝炎。我国现有酒民约1.6亿,其中9000万人长期饮酒;一般人群的饮酒率达59.5%,人均年饮纯酒精量计为3.6L,且逐年上升,对我国人民身体健康和社会发展构成了严重威胁。
目前西医尚无有效药物,在治疗上ALD仍以戒酒和营养支持为主,中医药有其自身的优势,根据病因及临床特点,将其归属为“伤酒”、“酒痞”、“酒疸”、“酒臌”等范畴。中医认为,酒为有毒之品,味甘、苦、辛,性温,过饮必伤脾胃肝胆而引起疾病。故其病因病机是饮酒过度导致脾胃损伤、湿热内蕴、脾失健运、气机不畅、气血失和、痰浊内生、气血痰搏结而致病。中医药治疗酒精性肝病多以活血化瘀、利水渗湿、理气化痰为主,并根据病症的不同阶段和不同症候加用清热药、补虚药等,即遵循中医理论对酒精性肝损伤防治原则,通过活血化积,补气健脾,升清降浊功效达到对肝脏的保护功能。
随着社会进步和经济发展,人类对自身健康日益关注和重视。中国具有药食同源的悠久历史,其独特的养生保健文化和产品不仅符合人类回归自然、达到提高生命质量、延缓衰老、增加寿命预期的愿望,而且具有毒副作用小、作用缓和等优势,在国内外日益受到重视。90年代以来,全球居民的健康消费逐年攀升,对保健食品的需求十分旺盛。随着经济的发展与生活水平的提高,人们的饮食发展趋势已从当初的温饱型转变为营养型,现正向保健型发展。在我国,随着生活条件的改善,酗酒人数增多,同时由于国内肝病主要由肝炎病毒引起,肝炎病毒携带者的数量更多,可能掩盖了实际上是酒精作为病因的肝病,因此,对于酒精性肝病预防保健至关重要。随着对酒精性肝损伤认识的不断深入,人们对酒精性肝损伤的保护意识逐渐增强,市场上也相继出现了一些解酒饮料和保健食品,如海王金樽、三奇堂养生健肝茶等,但相比免疫调节、辅助降血脂、抗衰老、抗疲劳等保健功能食品相对比较少,因此根据酒精性肝损伤的发病机制、中药的防治特点选择了山楂、五味子、丹参、葛根、黄芪五味可用于保健食品的物质,组成用于辅助保护肝脏的配方,制成保健食品—参芪五味保肝片。
发明内容
本发明提供了一种用于保护肝脏的保健食品,对酒精性肝损伤患者进行用药的同时进行辅助治疗,并降低药物的毒副作用,旨在临床上为更多的ALD患者服务,对于酒精性肝损伤人群具有重要意义。
本发明的保健食品选用了可用于保健食品的原料:山楂、丹参、五味子、黄芪和葛根。
山楂具有消食健胃,行气散瘀之功能。用于肉食积滞,胃脘胀,泻痢腹痛,瘀血经闭,产后瘀阻,心腹刺痛,散气疼痛,高脂血症。其主要含有黄酮、有机酸、鞣质等成分。具有降血脂增加冠脉流量,改善心肌缺血,降压,抑制血小板聚集,保护血管内皮细胞,增强免疫功能,抗衰老,抗菌,改善胃肠功能等作用。
丹参具有养心安神,凉血消痈,排脓生肌之功效,主要用于***,经痛、经闭、产后瘀血、胸腹或肢体瘀血疼痛、痈肿疮毒、心烦失眠等。主要含有醌、酮类等脂溶性化合物,如:丹参酮Ⅰ、丹参酮ⅡA、丹参醌,丹参素等水溶性成分。具有抑制脑血栓、改善冠脉循环、改善心肌缺血、改善微循环,降血脂、抗动脉硬化、改善血液流变性,抑制凝血,耐缺氧、抗炎抑菌,抑制肝损伤、抗肝纤维化,抗肿瘤等作用。
五味子具有润肺、滋肾、止汗、止泻、涩精之功效。主治咳喘、自汗、盗汗、遗精、久泻、神经衰弱等。含有木质素、三萜酸类及内酯类成分。具有抑制肝损伤、抗氧化、抗衰老、促进蛋白质合成、解毒、增强免疫功能、改善心脏功能、抗溃疡、抗应激等作用。
黄芪具有补气固表,托毒排脓,利尿生肌,主要用于气虚乏力,久泻脱肛,自汗,水肿,子宫脱垂,慢性肾炎蛋白尿、糖尿病、疮口久不愈合等证。主要含有多糖、皂苷、黄酮类成分,具有增强免疫功能,抗病毒、改善心肌损伤、保护心肌细胞、抗炎、降血糖等活性。
葛根具有解肌、退热、生津、透疹、升阳、止泻等功效。用于外感发热、头痛项强、口渴、消渴、麻疹不透、热痢泄泻等。主要含有异黄酮类、皂苷类成分。具有抗心肌缺血、改善心功能、扩张血管、抗高血压、抗心律失常、降血糖、降血脂、解热、抗癌、解毒、抗氧化、解酒、抗缺氧、抑制血小板聚集、保肝等作用。
本发明将上述五种物质组合在一起,通过活血化瘀,补气健脾,升清降浊功能达到对肝脏的保护作用。
具体的,本发明涉及的一种用于保肝的保健食品(参芪五味保肝片),是由如下原料制备而成:山楂、丹参、五味子、黄芪和葛根。
本发明的一种用于保肝的保健食品优选由如下重量份的原料制备而成:
山楂500-600重量份 五味子150-250重量份g
丹参350-450重重份 黄芪200-300重量份
葛根300-400重量份。
本发明的一种用于保肝的保健食品更优选由如下重量份的原料制备而成:
山楂550-600重量份 五味子180-230重量份
丹参380-420重重份 黄芪220-250重量份
葛根330-380重量份。
本发明提供了一种保肝的保健食品的制备方法,其包括如下步骤:
(1)原辅料的预处理
①山楂 前处理方法为:除去杂质及脱落的核。
②五味子 前处理方法为:除去杂质。
③丹参 前处理方法为:除去杂质和残茎,洗净,润透,切厚片,干燥。
④黄芪 前处理方法为:除去杂质,大小分开,洗净,润透,切厚片,干燥。
⑤葛根 前处理方法为:除去杂质,洗净,润透,切厚片,晒干。
(2)生产工艺:取五味子、丹参、葛根,加5-7倍量60-80%乙醇加热回流提取二到三次次,每次2-5小时,80-100目滤过,合并滤液,回收乙醇,浓缩至相对密度为1.15~1.20(50℃测)的稠膏;取山楂、黄芪,加8-10倍量水煎煮两到三次,每次煎煮2-4小时,80-100目滤过,合并滤液,浓缩至相对密度为1.15~1.20的稠膏,与上述稠膏混合,70-85℃减压干燥,粉成细粉,80-95%乙醇制颗粒,40-50℃,整粒,压片,包薄膜衣,制成片,分装,即得。
本发明提供的保肝的保健食品(参芪五味保肝片)具有明显保护肝脏作用。
本发明制备的保肝的保健食品,具有活血化积、补气健脾、升清降浊的作用,适用于酒精性肝损伤的人群。可制备成各种剂型,优选制备成片剂剂型,便于患者的服用和携带。
附图说明
图1为生产工艺简图
其中,A、B分别表示不同的洁净级别,A:表示一般洁净级,B:表示三十万级。
具体实施方式
生产工艺简图,见图1
制备方法实施例
配方:山楂556g、五味子167g、丹参389g、黄芪222g、葛根333g,共1667g。
制成总量:制成1000片,每片0.6g(相当于1.667g生药)。
服用方法:每天三次,每次3片
制备方法:
(1)取五味子167g、丹参389g、葛根333g,加5倍量70%乙醇加热回流提取两次,每次2小时,100目滤过,合并滤液,回收乙醇,浓缩至相对密度为1.15~1.20(50℃测)的稠膏备用;
(2)取山楂556g、黄芪222g,加8倍量水煎煮二次,每次煎煮2小时,100目滤过,合并滤液,浓缩致相对密度为1.15~1.20(50℃)的稠膏备用;
(3)将(1)(2)所得稠膏混合,85℃减压干燥,粉成细粉,95%乙醇制颗粒,50℃,整粒,压片,包薄膜衣,即得(参芪五味保肝片)保肝的保健食品。
以下通过试验例来进一步阐述发明所述保健食品的有益效果,这些试验例包括了本发明保健食品(以下称为参芪五味保肝片)的辅助保护肝脏功能试验。
试验例对小鼠酒精性肝损伤的影响
1、试验材料
1.1动物:KM小鼠,SPF级,购自长春生物制品研究所有限责任公司,合格证号:201500011043。
1.2药物及试剂:参芪五味保肝片,由本院剂型室提供;乙醇,北京化工厂,批号:20160128。甘油三酯(TG),批号:20151124;丙二醛(MDA),批号:20151013;还原型谷胱甘肽(GSH),批号:20151124,南京建成生物工程研究所。
1.3仪器:UV-5100型紫外可见光光度计,上海元析仪器有限公司。
2、试验方法与结果
取小鼠50只,动物适应环境后,随机分为5组:空白对照组,模型组,参芪五味保肝片5.0、2.5、1.25g原料/kg三个剂量给药组。每日灌服给药一次,连续给药45天,每周称体重一次,观察不同给药时间体重变化情况。末次给药后1h,将各组动物一次灌胃给与50%乙醇,12ml/kg,空白对照组灌服同体积蒸馏水,之后禁食6小时,处死动物取肝,检测肝组织中MDA、TG、GSH含量的变化。结果见表1、2。
注:Δ与模型组比较P<0.05,ΔΔ与模型组比较P<0.01,
ΔΔΔ与模型组比较P<0.001;*与对照组比较P<0.05,
**与对照组比较P<0.01,***与对照组比较P<0.001,下同。
结果可见,参芪五味保肝片对不同时间小鼠体重无明显影响;可明显抑制酒精性肝损伤小鼠肝组织MDA、TG含量,升高GSH含量,表明参芪五味保肝片具有明显的保肝作用。
本发明配方口服能明显抑制酒精性肝损伤小鼠肝组织MDA、TG含量,升高GSH含量,对不同时间小鼠体重无明显影响,表明其对酒精性肝损伤具有明显的保护作用。适用于长期饮酒的人群,是一个很好的具有辅助保护肝脏功能的保健食品。
以上实施例,仅以说明为目的,并不用以限制本发明,凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (3)
1.一种用于保肝的保健食品,其特征在于由如下重量份的原料制备而成:
山楂556g、五味子167g、丹参389g、黄芪222g、葛根333g;按照以下方法制备:
原辅料的预处理:
①山楂前处理方法为:除去杂质及脱落的核;
②五味子前处理方法为:除去杂质;
③丹参前处理方法为:除去杂质和残茎,洗净,润透,切厚片,干燥;
④黄芪前处理方法为:除去杂质,大小分开,洗净,润透,切厚片,干燥;
⑤葛根前处理方法为:除去杂质,洗净,润透,切厚片,晒干;
制备过程:
(1)取五味子、丹参、葛根,加5倍量70%乙醇加热回流提取两次,每次2小时,100目滤过,合并滤液,回收乙醇,浓缩至50℃测相对密度为1.15~1.20的稠膏备用;
(2)取山楂、黄芪,加8倍量水煎煮二次,每次煎煮2小时,100目滤过,合并滤液,浓缩至50℃测相对密度为1.15~1.20的稠膏备用;
(3)将(1)、(2)所得稠膏混合,85℃减压干燥,粉成细粉,95%乙醇制颗粒,50℃干燥,整粒,压片,包薄膜衣,即得保肝的保健食品。
2.根据权利要求1的用于保肝的保健食品的制备方法,其包括如下步骤:
原辅料的预处理:
①山楂前处理方法为:除去杂质及脱落的核;
②五味子前处理方法为:除去杂质;
③丹参前处理方法为:除去杂质和残茎,洗净,润透,切厚片,干燥;
④黄芪前处理方法为:除去杂质,大小分开,洗净,润透,切厚片,干燥;
⑤葛根前处理方法为:除去杂质,洗净,润透,切厚片,晒干;
制备过程:
(1)取五味子、丹参、葛根,加5倍量70%乙醇加热回流提取两次,每次2小时,100目滤过,合并滤液,回收乙醇,浓缩至50℃测相对密度为1.15~1.20的稠膏备用;
(2)取山楂、黄芪,加8倍量水煎煮二次,每次煎煮2小时,100目滤过,合并滤液,浓缩至50℃测相对密度为1.15~1.20的稠膏备用;
(3)将(1)、(2)所得稠膏混合,85℃减压干燥,粉成细粉,95%乙醇制颗粒,50℃干燥,整粒,压片,包薄膜衣,即得保肝的保健食品。
3.根据权利要求1的用于保肝的保健食品在制备预防和治疗酒精性肝损伤的保健产品中的应用。
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