CN112274547A - 一种含有水飞蓟提取物和1,6二磷酸果糖的组合物及其在护肝、醒酒、抗疲劳中的应用 - Google Patents
一种含有水飞蓟提取物和1,6二磷酸果糖的组合物及其在护肝、醒酒、抗疲劳中的应用 Download PDFInfo
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- CN112274547A CN112274547A CN202011261048.XA CN202011261048A CN112274547A CN 112274547 A CN112274547 A CN 112274547A CN 202011261048 A CN202011261048 A CN 202011261048A CN 112274547 A CN112274547 A CN 112274547A
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- extract
- silybum marianum
- fructose
- diphosphate
- herba silybi
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Abstract
本发明公开了一种组合物,组合物含有水飞蓟提取物和1,6‑二磷酸果糖或其衍生物、或其盐;水飞蓟提取物为水飞蓟提取物微胶囊形式和/或水飞蓟提取物脂质体形式和/或水飞蓟提取物自微乳化形式,水飞蓟提取物与FDP的组合物具有减少肝损伤、防止宿醉和抗疲劳的功效,尤其是能够快速起效减少肝损伤和快速醒酒。
Description
技术领域
本发明涉及一种组合物,具体涉及减少肝损伤等效果的含有水飞蓟提取物和1,6二磷酸果糖的组合物及其应用。
背景技术
水飞蓟为一年生或两年生草本植物,原生于南欧和北非等地,在欧洲和非洲有几千年的栽培和使用历史,为民间药用植物。水飞蓟被广泛用作治疗肝脏疾病和心血管疾病的药物。
水飞蓟提取物以水飞蓟Silybummarianum的干燥果实为原料,商品提取物通常标化为含总水飞蓟素80%。水飞蓟素是多酚类的复杂混合物,包括七种关系密切的黄酮醇-木质素加成物(水飞蓟宾A、水飞蓟宾B、异水飞蓟宾A、异水飞蓟宾B、水飞蓟亭、异水飞蓟亭及水飞蓟宁)和一种类黄酮黄杉素(taxifolin)。水飞蓟宾是水飞蓟素的半纯化部分,主要是两种非对映异构体(水飞蓟宾A和水飞蓟宾B)的混合物,其比例大约为1:1。水飞蓟宾混合物表现出多种药理作用,尤其是在肝脏中,并且有一些临床证据表明水飞蓟宾可作为酒精和儿童“A”级肝硬化的支持元素。水飞蓟宾的化学结构为
在许多国家,水飞蓟宾可直接作为药物或作为药物成分,并用于治疗毒性肝损伤(例如,在死亡上限的情况下进行IV治疗);作为慢性肝炎和肝硬化的辅助治疗手段。中国天津天士力圣特制药有限公司也上市药品“水飞蓟宾胶囊”(国药准字H20040299),35mg*30粒/盒(每粒含有水飞蓟宾35mg),用于急慢性肝炎、脂肪肝的功能异常的恢复。推荐服用剂量成人3次/日,2-4粒/次。
1,6二磷酸果糖,简称FDP,是存在于人体内的细胞代谢物,能调节葡萄糖代谢中多种酶系的活性,改善细胞缺氧、缺血的状态,有利于受损肝细胞的恢复。1,6二磷酸果糖一般以盐类形式存在,应用上以钠盐居多,即果糖-1,6-二磷酸钠,除钠盐外还有果糖-1,6-二磷酸钙、果糖-1,6-二磷酸镁、果糖-1,6-二磷酸锂等。其中果糖-1,6-二磷酸钠和果糖-1,6-二磷酸钙应用较多。
北京华靳制药有限公司推出的瑞安吉牌果糖二磷酸钠口服溶液(国药准字H19990353),用于改善冠心病的心绞痛、剂型心肌梗死、心律失常和心理衰竭的心肌缺血以及病毒性心肌炎的辅助治疗。亦可用于改善脑梗死、脑出血等引起的闹缺氧症状。口服,1-2g(10-20ml),2-3次/日。上海天龙药业有限公司推出的洛普欣牌果糖二磷酸钠片(国药准字H20010623),0.25g*24片,适用于心肌缺血疾病的辅助治疗。口服,4片/次,3次/日。
南京圣诺生物科技实业有限公司推出的福达平(磷酸果糖)胶囊[卫食健字(1997)第553号]是以果糖二磷酸钠300mg/粒、维生素B130mg/粒、维生素B630mg/粒、L-天门冬氨酸40mg/粒为主要原料制成的保健食品。经动物实验评价,具有耐缺氧、抗疲劳的保健功能。口服1-2粒/次,2次/日。浙江德清东立保健品有限公司推出的紫福口服液[卫食健字(1998)第95号]主要成分为果糖二磷酸钠(FDP,2500mg/100ml),L-天门冬酰胺、蜂蜜、山梨酸钾、水。经功能试验证实,本品具有抗疲劳、耐缺氧的保健作用,20mlx30支,口服,1-2支/天。
CN103623022A发明专利申请中涉及1,6-二磷酸果糖的组合物,主要成分包括1,6-二磷酸果糖金属盐的化合物、人参,用于心肌营养增强同时具有免疫增强的保健品。该发明专利申请添加或用灵芝孢子粉及乙酸硒可以使上述增强免疫细胞活性、抗肿瘤、逆转肿瘤的效果更优。由于1,6-二磷酸果糖使运动过程的红细胞增加粘附免疫组合物的能力,组合物中的人参、灵芝多糖具有免疫细胞活力功效:该申请在机理上增强免疫细胞活性、抗肿瘤、逆转肿瘤。该申请用于心肌营养尤其是运动营养物质,中老年身体锻炼服用的效果更好。
US4764508A发明专利申请中涉及包含水飞蓟宾,水飞蓟素和水飞蓟宾与磷脂的亲脂性复合物的新型化合物,以及通过非常规方法制备这些复合物的方法。新化合物在胃肠道的吸收明显更大,导致血浆水平高于单独的黄烷醇。所得到的药代动力学和药理学参数的改善使得该物质可以有利地用于治疗具有毒性,代谢或感染性或变性性质的急性和慢性肝病。
CN106727626A公开了1,6二磷酸果糖在制备治疗酒精肝损伤药物中的应用,采用1,6二磷酸果糖治疗急性酒精肝损伤;CN111494564A公开了一种复合型保肝解酒片的制备方法,将水飞蓟宾和环糊精一起制备成水飞蓟宾微囊从而提升了水飞蓟宾的水溶性,解决了水飞蓟宾在水中不溶的技术问题,与荷叶、芦根、蒲公英以及虫草菌丝体进行协同使用,制备的复合型保肝解酒片。
以上产品和试验,都是在饮酒、或者饮用酒精类饮料前采用保健产品进行护肝;而很多时候饮酒、或者饮用酒精类饮料是非计划的,消费者无法在饮酒、或者饮用酒精类饮料前摄入保健产品进行护肝,只能在饮酒后、聚会散去后采用保健产品进行护肝。市场上现在的醒酒护肝产品大多需要提前服用,并且提前相当一段长时间进行服用,才能发挥护肝、防止宿醉的效果。
另外,现在的一些产品见效也相对快,成分都直接参与能量循环,但药效很快到高峰期,之后也快速的下降;即摄入吸收后血液中功能成分含量的迅速达到高峰,代谢后又迅速下降,无法起到持续护肝作用,除非持续摄入;且功效成分含量的峰值太高,并没有证据表明功效成分血液含量与护肝效果会表现出线性关系,且峰值过高也可能带来一定的副作用。因此一款能够快速起效,有一定持续效果的减少酒精对肝脏伤害的产品是十分必要的,而产品还具有抗疲劳的效果是更加优异的。
发明内容
本发明的目的在于针对现有技术的不足之处,提供一种组合物,含有水飞蓟提取物和1,6-二磷酸果糖或其衍生物、或其盐。
进一步的,水飞蓟提取物包括水飞蓟宾A、水飞蓟宾B、异水飞蓟宾A、异水飞蓟宾B、水飞蓟亭、异水飞蓟亭、水飞蓟宁、黄杉素中的一种或多种;进一步优选的,水飞蓟提取物包括水飞蓟宾A和其他类型水飞蓟提取物的组合。
进一步的,水飞蓟提取物为水飞蓟提取物微胶囊形式和/或水飞蓟提取物脂质体形式和/或水飞蓟提取物自微乳化形式,优选为水飞蓟提取物-磷脂的形式、水飞蓟提取物-磷脂-胆固醇的形式、水飞蓟提取物-环糊精的形式的一种或多种。
进一步优选为水飞蓟提取物-磷脂-胆固醇的脂质体形式和水飞蓟提取物-磷脂复合物的形式复配,或为飞蓟提取物-磷脂-胆固醇的脂质体形式和水飞蓟提取物-环糊精的形式复配。
进一步的,1,6-二磷酸果糖的盐包括果糖-1,6-二磷酸钠、果糖-1,6-二磷酸镁、果糖-1,6-二磷酸钙和果糖-1,6-二磷酸锶中的一种或多种的混合,优先的,1,6-二磷酸果糖的盐为果糖-1,6-二磷酸钠。
进一步的,组合物中水飞蓟提取物含量为1-99%(w/w),优选为10-60%(w/w),进一步优选为20-40%(w/w);果糖-1,6-二磷酸钠为1-99%(w/w),优选为40-90%(w/w),进一步优选为60-80%(w/w)。
进一步的,水飞蓟提取物中的水飞蓟宾(水飞蓟宾A和水飞蓟宾B)占水飞蓟宾A、水飞蓟宾B、异水飞蓟宾A、异水飞蓟宾B、水飞蓟亭、异水飞蓟亭、水飞蓟宁、黄杉素总含量的20%以上,具有为30%以上、40%以上、50%以上、60%以上、70%以上、80%以上、90%以上、95%以上、96%以上、97%以上、98%以上、99%以上或100%。
水飞蓟提取物的纯度为50%以上,具有60%以上、70%以上、80%以上、90%以上、95%以上、96%以上、97%以上、98%以上、99%以上或100%。
本发明还提供了一种产品,包括上述组合物,所述产品剂型为注射液、口服液、片剂、硬胶囊、软胶囊、糖果、固体饮料、液体饮料、膏滋中的一种。
进一步的,所述产品还包括辅料;其中辅料包括:水、赋形剂、色素、甜味剂、pH调节剂、增稠剂、粘合剂、崩解剂、填充剂。
本发明还提供了组合物在肝损伤类药品、保健食品、膳食补充剂和食品中的应用;
或/和在护肝类药品、保健食品、膳食补充剂和食品中的应用;
或/和在醉酒类药品、保健食品、膳食补充剂和食品中的应用;
或/和在抗疲劳类的药品、保健食品、膳食补充剂和食品中的应用;
或/和在心脏保护类的药品、保健食品、膳食补充剂和食品中的应用;
或/和在抗抑郁和抗焦虑的药品、保健食品、膳食补充剂和食品中的应用。
相对于单独水飞蓟提取物和单独1,6-二磷酸果糖而言,水飞蓟提取物和1,6-二磷酸果糖的组合物可在多种器官和组织中产生协同作用。尤其是是在护肝功效上。水飞蓟提取物清除自由基、稳定细胞膜、修复细胞;FDP可调节细胞代谢,同时自身也作为高能酵解底物,直接产生ATP,提供能量。组合物可以更好的清除细胞内活性氧自由基、抗炎;修复和稳定细胞、提高细胞的解毒排毒能力,避免组织细胞在饮酒、过度疲劳、外伤等不利条件下受到进一步损伤。因此组合物在抗疲劳作用、心肌细胞保护作用,抗抑郁和焦虑作用上也有很好的表现和应用前景。以护肝作用和心肌保护作用为例:
对于护肝作用:水飞蓟提取物清楚干细胞内活性氧自由基,稳定肝细胞膜,保护肝脏,强化排毒。而FDP作为代谢调节剂,可减轻肝脏细胞缺血再灌注损伤,同时FDP还是细胞内代谢的中间产物,是糖原合成的有效底物,可有效的在短时间内促进肝细胞内的糖原合成。因此水飞蓟提取物和FDP在护肝作用上相互协同,使得对肝脏的保护作用相较于单一成分方案获得了大幅度提升;
对于心肌细胞保护作用:水飞蓟提取物可降低心肌细胞的受损程度,增加SOD活性,对细胞膜电位起到了抑制作用,改善线粒体功能。而FDP可以透过心肌细胞膜直接作为外源性底物,产生ATP为心肌功能,同时FDP也参与调解心肌细胞糖代谢,恢复和改善心脏功能。
附图说明:
图1为1h作用下不同组对酒精造模的肝损伤效果图;
图2为2h作用下不同组对酒精造模的肝损伤效果图;
图3为3h作用下不同组对酒精造模的肝损伤效果图;
具体实施方式
为了便于本领域技术人员的理解,下面结合实施例对本发明作进一步的说明,实施方式提及的内容并非对本发明的限定。
实施例1
一种组合物,含有水飞蓟提取物和果糖-1,6-二磷酸钠,水飞蓟提取物中水飞蓟宾(包括水飞蓟宾A和水飞蓟宾B)占水飞蓟提取物的80%,水飞蓟提取物为水飞蓟-磷脂复合物的形式,水飞蓟提取物为40%(w/w),果糖-1,6-二磷酸钠为60%(w/w)。
实施例2
一种组合物,含有水飞蓟提取物和果糖-1,6-二磷酸钠,水飞蓟提取物中水飞蓟宾占水飞蓟提取物的70%,水飞蓟提取物为水飞蓟-磷脂复合物的形式,水飞蓟提取物为20%(w/w),果糖-1,6-二磷酸钠为80%(w/w)。
实施例3
一种组合物,含有水飞蓟提取物和果糖-1,6-二磷酸钠,水飞蓟提取物中水飞蓟宾占水飞蓟提取物的90%,水飞蓟提取物为水飞蓟-磷脂复合物的形式,水飞蓟提取物为33.3%(w/w),果糖-1,6-二磷酸钠为66.7%(w/w)。
实施例4
一种组合物,含有水飞蓟提取物和果糖-1,6-二磷酸钠,水飞蓟提取物中水飞蓟宾占水飞蓟提取物的80%,水飞蓟提取物为水飞蓟-磷脂复合物的形式,水飞蓟提取物为1%(w/w),果糖-1,6-二磷酸钠为99%(w/w)。
实施例5
一种组合物,含有水飞蓟提取物和果糖-1,6-二磷酸钠,水飞蓟提取物中水飞蓟宾占水飞蓟提取物的80%,水飞蓟提取物为水飞蓟-磷脂复合物的形式,水飞蓟提取物为99%(w/w),果糖-1,6-二磷酸钠为1%(w/w)。
实施例6
一种组合物,含有水飞蓟提取物和果糖-1,6-二磷酸钠,水飞蓟提取物中水飞蓟宾占水飞蓟提取物的80%,水飞蓟提取物为水飞蓟-磷脂复合物的形式,水飞蓟提取物为10%(w/w),果糖-1,6-二磷酸钠为90%(w/w)。
实施例7
一种组合物,含有水飞蓟提取物和果糖-1,6-二磷酸钠,水飞蓟提取物中水飞蓟宾占水飞蓟提取物的80%,水飞蓟提取物为水飞蓟-磷脂复合物的形式,水飞蓟提取物为20%(w/w),果糖-1,6-二磷酸钠为80%(w/w)。
实施例8
一种组合物,含有水飞蓟提取物和果糖-1,6-二磷酸钠,水飞蓟提取物中水飞蓟宾占水飞蓟提取物的80%,水飞蓟提取物为水飞蓟-磷脂复合物的形式,水飞蓟提取物为50%(w/w),果糖-1,6-二磷酸钠为50%(w/w)。
实施例9
一种组合物,含有水飞蓟提取物和果糖-1,6-二磷酸钠,水飞蓟提取物中水飞蓟宾占水飞蓟提取物的90%,水飞蓟提取物为水飞蓟-磷脂复合物的形式,水飞蓟提取物为40%(w/w),果糖-1,6-二磷酸钠为60%(w/w)。
实施例10
一种组合物,含有水飞蓟提取物和果糖-1,6-二磷酸镁,水飞蓟提取物中水飞蓟宾占水飞蓟提取物的95%,水飞蓟提取物为水飞蓟-磷脂复合物的形式,水飞蓟提取物为33.3%(w/w),果糖-1,6-二磷酸钠为66.7%(w/w)。
实施例11
一种口服饮用产品,含有水飞蓟提取物和果糖-1,6-二磷酸钠,水飞蓟提取物中水飞蓟宾占水飞蓟提取物的80%,水飞蓟提取物为水飞蓟-磷脂复合物的形式,水飞蓟提取物为1.2g/100ml,果糖-1,6-二磷酸钠为2.4g/100ml。
实施例12
一种口服饮用产品,含有水飞蓟提取物和果糖-1,6-二磷酸钠,水飞蓟提取物中水飞蓟宾占水飞蓟提取物的80%,水飞蓟提取物为水飞蓟提取物-磷脂-胆固醇脂质体的形式,水飞蓟提取物为0.6g/100ml,果糖-1,6-二磷酸钠为1.2g/100ml。
实施例13
一种口服饮用产品,含有水飞蓟提取物和果糖-1,6-二磷酸钠,水飞蓟提取物中水飞蓟宾占水飞蓟提取物的80%,水飞蓟提取物为水飞蓟提取物-磷脂-胆固醇脂质体的形式,水飞蓟提取物为2.4g/100ml,果糖-1,6-二磷酸钠为4.8g/100ml。
实施例14
一种口服饮用产品,含有水飞蓟提取物和果糖-1,6-二磷酸钠,水飞蓟提取物中水飞蓟宾占水飞蓟提取物的60%,水飞蓟提取物为水飞蓟提取物-磷脂复合物的形式,水飞蓟提取物为2.4g/100ml,果糖-1,6-二磷酸钠为4.8g/100ml。
实施例15
一种口服饮用产品,含有水飞蓟提取物和果糖-1,6-二磷酸钠,水飞蓟提取物中水飞蓟宾占水飞蓟提取物的90%,水飞蓟提取物为水飞蓟-磷脂复合物的形式,水飞蓟提取物为1.2g/100ml,果糖-1,6-二磷酸钠为2.4g/100ml。
实施例16
一种口服饮用产品,含有水飞蓟提取物和果糖-1,6-二磷酸钠,水飞蓟提取物中水飞蓟宾占水飞蓟提取物的80%,水飞蓟提取物为水飞蓟-磷脂复合物的形式,水飞蓟提取物为1.2g/100ml,果糖-1,6-二磷酸钠为2.4g/100ml;还含有甜味剂与酸味剂,以掩盖产品的不良味道。
实施例17
一种口服饮用产品,含有水飞蓟提取物和果糖-1,6-二磷酸钠,水飞蓟提取物中水飞蓟宾占水飞蓟提取物的80%,水飞蓟提取物为水飞蓟-磷脂复合物的形式,水飞蓟提取物为1.2g/100ml,果糖-1,6-二磷酸钠为2.4g/100ml,还含有增稠剂,以提升产品的厚重感。
对比例1
一种口服饮用产品,含有水飞蓟提取物,水飞蓟提取物中水飞蓟宾占水飞蓟提取物的80%,水飞蓟提取物为水飞蓟-磷脂复合物的形式,水飞蓟提取物为1.2g/100ml。
对比例2
一种口服饮用产品,含有果糖-1,6-二磷酸钠,果糖-1,6-二磷酸钠为2.4g/100ml。
采用实施例11、对比例1、对比例2进行试验,实施例11、对比例1、对比例2中不含其它功效成分。本发明技术方案带来了显著有益效果。
动物:SPF级雄性小鼠(20±2g):将小鼠置于动物实验室,室温培养,空气湿度约为55%~65%。分笼饲养,给予日常鼠粮和蒸馏水饲养,不限制进食量及饮水量。
护肝效果动物试验:
分组:取50只小鼠随机平均分为5组,即为:空白组、模型对照组、组合物组(实施例11)、水飞蓟组(对比例1)、FDP组(对比例2),
造模:各组小鼠禁食12h,空白对照组灌胃体积的生理盐水,其他四组分别用酒精产品牛栏山二锅头灌胃(市售,酒精度为52度),灌胃量根据小鼠体重进行计算(10mL/kg体重);组合物组(实施例11)、水飞蓟组(对比例1)、FDP组(对比例2)灌胃酒精产品后30min立即灌胃相应组的产品(2mL/kg体重),空白对照组和模型对照组灌胃相应体积的生理盐水。
采样检测:干预1h后处死小鼠取血,静止后3000rpm离心15分钟出血清,冻存留作AST、ALT检测,随后采用试剂盒检测血清中的AST、ALT含量。
重复上述试验方式再用40只小鼠进行试验分为4组,即为:模型组、组合物组(实施例11)、水飞蓟组(对比例1)、FDP组(对比例2),2h后处理小鼠取血,采用相同的方式测试血清中的ALT、AST含量。
重复上述试验方式再用40只小鼠进行试验分为4组,即为:模型组、组合物组(实施例11)、水飞蓟组(对比例1)、FDP组(对比例2),3h后处理小鼠取血,采用相同的方式测试血清中的ALT、AST含量。
表1 1h作用下不同组对酒精造模的护肝的影响
ALT(U/L) | AST(U/L) | |
空白组 | 51.2±7.2 | 114.5±10.8 |
模型组 | 109.2±11.9 | 233.2±20.3 |
组合物组 | 75.9±8.0 | 182.9±16.9 |
水飞蓟组 | 100.7±9.1 | 221.7±18.4 |
FDP组 | 95.2±11.6 | 213.2±17.6 |
表2 2h作用下不同组对酒精造模的护肝的影响
ALT(U/L) | AST(U/L) | |
模型组 | 105.2±11.7 | 229.8±21.1 |
组合物组 | 68.3±11.6 | 168.9±15.1 |
水飞蓟组 | 94.7±7.2 | 203.2±15.7 |
FDP组 | 86.1±10.8 | 201.7±15.3 |
表3 3h作用下不同组对酒精造模的护肝的影响
由表1-3的数据可知,不同作用时间下,组合物组、水飞蓟组、FDP组小鼠体内谷丙转氨酶和谷草转氨酶含量均有明显降低(相对于模型组p<0.01),说明水飞蓟、FDP以及其他的组合物均具有缓解酒精导致的肝损伤的效果。
且随着时间变长,小鼠体内谷丙转氨酶和谷草转氨酶含量逐步降低(每小时之间相同指标p<0.05)。
将ALT或AST的指标上,将模型组和对应组的差值定义为某组减少量,将模型组和组合物组差值定义为组合物组减少量,将模型组和水飞蓟物差值定义为水飞蓟组减少量,将模型组和FDP差值定义为FDP组减少量,将水飞蓟组减少量与FDP组减少量定义为单独使用减少量之和。
由表2-3和说明书附图2-3,2h和3h时组合物组减少量和单独使用减少量之和没有显著性差异(p>0.05),而由表1和说明书附图1,组合物组减少量明显大于单独使用减少量之和(p<0.05),说明水飞蓟提取物与FDP组合物即水飞蓟提取物与FDP组合使用共同作用时,能够更快的起到减少肝损伤的效果。
其协同作用机理并且能够快速起效机理正在研究中,但较为可能的情况是,FDP进入细胞内参与三羧酸循环,增强细胞能量产生,有利于水飞蓟提取物转运进入细胞内,提高了生物利用度;另一方面,水飞蓟提取物在修复细胞和稳定目标细胞膜的作用,也促进后续FDP和后续水飞蓟的渗透和转运进入目标细胞。使得细胞结构和细胞膜更稳定,两个方向作用机制相互促进,协同增效。
醒酒效果试验:
取40只小鼠随机平均分为4组,即为:对照组、组合物组(实施例11)、水飞蓟组(对比例1)、FDP组(对比例2),三组分别灌胃牛栏山二锅头(市售,酒精度为52度),灌胃量根据小鼠体重进行计算(20mL/kg体重),全部小鼠呈现出昏睡或者无法正常行走的醉酒情况。然后每组分别立即灌胃相应组的产品(2mL/kg体重),对照组灌胃相应体积的生理盐水,碰触小鼠,观察小鼠的站立(四肢能够支撑起身体,后腹和前胸均能离地)和行走情况,以评判小鼠的醒酒情况。
表4不同组对醉酒小鼠的醒酒情况的影响
由表4的结果可知,水飞蓟提取物与FDP组合使用有助于醉酒小鼠快速醒酒,0.5小时就出现能够站立的小鼠(该小鼠的后腹离开底面),4个小时10只小鼠可以正常的行走。表4所展现的效果,也佐证了水飞蓟提取物与FDP组合使用有助更快减少肝损伤的效果。
抗疲劳试验:
取40只小鼠随机平均分为4组,即为:对照组、组合物组(实施例11)、水飞蓟组(对比例1)、FDP组(对比例2),分三次灌胃,每组每次分别灌胃相应组的产品(2mL/kg体重),三次灌胃的间隔时间为4小时;最后一次灌胃后1小时后,进行负重游泳力竭游泳时间试验;空白対照组灌胃相应量的生理盐水。
在小鼠尾根部各负荷其体重5%的铅丝作为重物,放入缸内水温(25±1)℃,保证小鼠在水中不用尾巴接触箱底。当小鼠头部沉入水中,10s内不能浮出水面的时间,此时间即为小鼠力竭游泳时间。
表5不同组对小鼠力竭游泳时间的影响
组别 | 力竭游泳时间(min) |
空白对照组 | 12.1±2.6 |
组合物组 | 18.9±2.9 |
水飞蓟组 | 15.5±3.3 |
FDP组 | 16.7±2.1 |
由表5可知,组合物相对于空白对照组,小鼠负重的力竭游泳时间有明显延长(p<0.01),可见水飞蓟提取物与FDP的组合物在抗疲劳上也有显著的效果。
结论:水飞蓟提取物与FDP的组合物具有减少肝损伤、宿醉感和疲劳感的功效,尤其是能够快速起效,减少肝损伤和醒酒,特别是减少因饮酒或过度疲劳引起的肝损伤。
本技术领域技术人员可以理解,除非另外定义,这里使用的所有术语(包括技术术语和科学术语),具有与本发明所属领域中的普通技术人员的一般理解相同的意义。还应该理解的是,诸如通用字典中定义的那些术语,应该被理解为具有与现有技术的上下文中的意义一致的意义,并且除非像这里一样被特定定义,否则不会用理想化或过于正式的含义来解释。
应当理解,以上借助优选实施例对本发明的技术方案进行的详细说明是示意性的而非限制性的。本领域的普通技术人员在阅读本发明说明书的基础上可以对各实施例所记载的技术方案进行修改,或者对其中部分技术特征进行等同替换;而这些修改或者替换,并不使相应技术方案的本质脱离本发明各实施例技术方案的精神和范围。
Claims (9)
1.一种组合物,其特征在于:含有水飞蓟提取物和1,6-二磷酸果糖或其衍生物、或其盐。
2.根据权利要求1所述组合物,其特征在于:水飞蓟提取物包括水飞蓟宾A、水飞蓟宾B、异水飞蓟宾A、异水飞蓟宾B、水飞蓟亭、异水飞蓟亭、水飞蓟宁、黄杉素中的一种或多种;
和/或
水飞蓟宾A、水飞蓟宾B、异水飞蓟宾A、异水飞蓟宾B、水飞蓟亭、异水飞蓟亭、水飞蓟宁、黄杉素的衍生物的一种或多种;优选为硫代烷基脂类衍生物。
3.根据权利要求1所述组合物,其特征在于:水飞蓟提取物为水飞蓟提取物微胶囊形式和/或水飞蓟提取物脂质体形式和/或水飞蓟提取物自微乳化形式,优选为水飞蓟提取物-磷脂的形式、水飞蓟提取物-磷脂-胆固醇的形式、水飞蓟提取物-环糊精的形式的一种或多种;进一步优选为水飞蓟提取物-磷脂-胆固醇的脂质体形式和水飞蓟提取物-磷脂复合物的形式复配,或为飞蓟提取物-磷脂-胆固醇的脂质体形式和水飞蓟提取物-环糊精的形式复配。
4.根据权利要求1的所述组合物,其特征在于:1,6-二磷酸果糖的盐包括果糖-1,6-二磷酸钠、果糖-1,6-二磷酸镁、果糖-1,6-二磷酸钙和果糖-1,6-二磷酸锶中的一种或多种的混合。
5.根据权利要求1的所述组合物,其特征在于:水飞蓟提取物含量为1-99%(w/w),优选为10-60%(w/w),进一步优选为20-40%(w/w);果糖-1,6-二磷酸钠为1-99%(w/w),优选为40-90%(w/w),进一步优选为60-80%(w/w)。
6.根据权利要求1的所述组合物,其特征在于:水飞蓟提取物中的水飞蓟宾占水飞蓟提取物的量为20%以上,优选为30%以上、40%以上、50%以上、60%以上、70%以上、80%以上、90%以上、95%以上、96%以上、97%以上、98%以上、99%以上或100%。
7.一种产品,包括权利要求1-6之一的所述组合物,所述产品剂型为注射液、口服液、片剂、硬胶囊、软胶囊、糖果、固体饮料、液体饮料、膏滋中的一种。
8.根据权利要求7所述的产品,其特征在于,还包括辅料;其中辅料包括:水、赋形剂、色素、甜味剂、pH调节剂、增稠剂、粘合剂、崩解剂、填充剂。
9.权利要求1-6之一的所述组合物、权利要求7、8所述的产品,在护肝类药品、保健食品、膳食补充剂和/或食品中的应用;
或/和在醉酒类药品、保健食品、膳食补充剂和/或食品中的应用;
或/和在抗疲劳类的药品、保健食品、膳食补充剂和/或食品中的应用;
或/和在心脏保护类的药品、保健食品、膳食补充剂和/或食品中的应用;
或/和在抗抑郁和抗焦虑的药品、保健食品、膳食补充剂和/或食品中的应用。
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WO2024127440A1 (en) * | 2022-12-13 | 2024-06-20 | Alchimia Innovazione Srl | Food product for use in the prevention and treatment of alcohol- induced hangovers |
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CN115607583A (zh) * | 2021-03-18 | 2023-01-17 | 南京北极光生物科技有限公司 | 一种含水飞蓟提取物的组合物及其在制备膳食补充剂中的应用 |
CN115607583B (zh) * | 2021-03-18 | 2024-05-31 | 南京北极光生物科技有限公司 | 一种含水飞蓟提取物的组合物及其在制备膳食补充剂中的应用 |
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