CN110575452A - 用于缓解变态反应症状的表儿茶素 - Google Patents
用于缓解变态反应症状的表儿茶素 Download PDFInfo
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- CN110575452A CN110575452A CN201910908535.1A CN201910908535A CN110575452A CN 110575452 A CN110575452 A CN 110575452A CN 201910908535 A CN201910908535 A CN 201910908535A CN 110575452 A CN110575452 A CN 110575452A
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- epicatechin
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- food
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Abstract
本发明涉及用于缓解变态反应症状的表儿茶素。本发明涉及用于预防或减轻变态反应性障碍和/或变态反应的症状的表儿茶素。本发明进一步涉及用于所述用途的食物、食物产品、食物补充剂或药物产品形式的表儿茶素。
Description
本申请为2012年8月23日提交的、发明名称为“用于缓解变态反应症状的表儿茶素”的PCT申请PCT/EP2012/066388的分案申请,所述PCT申请进入中国国家阶段的日期为2014年2月24日,申请号为201280041087.6。
发明领域
本发明涉及用于二级预防变态反应性障碍和/或变态反应的表儿茶素。
发明背景
变态反应性障碍的发病率在发达国家中显著增加,并且已知多种因素(例如环境、遗传学、卫生学、膳食)影响它们的发生。对于易感个体,变态反应可以从婴儿早期开始,例如特应性湿疹,限制为或随后发展成食物变态反应。呼吸道变态反应例如变态反应性鼻炎和哮喘发生在以后的生活中,并且完成变态反应现象的后遗症。变态反应相应于对环境(例如粉尘螨或花粉)中或食物(例如乳、蛋、坚果或小麦)中正常存在的多种变应原的失调的免疫应答。对理解变态反应的病理生理学的最新进展已经表明一系列复杂的免疫细胞相互作用,其可以被调节来影响对变应原的敏化(即预防)或有助于缓解变态反应的现象和症状。
目前,对于变态反应可用的大多数治疗选择例如皮质类固醇和抗组胺剂是针对治疗不同的变态反应症状的。然而为了证明非常有效,多种因素例如施用剂量、途经和方案说明了这些治疗的功效,虽然有副作用,所述的副作用有时与长期使用这些药物有关。
预防变态反应性障碍的发生或控制变态反应性障碍症状的营养干预是一种有希望的替代药物的选择,并且已经在很多临床前和临床环境下评估。通常,已经公开了益生菌(Kalliomaki等人,Lancet.2001,357:1076-9)、益生元(Arslanoglu等人,2008,J Nutr138:1091-1095)和多不饱和脂肪酸(Dunstan等人,2003,J Allergy Clin Immunol 112:1178-1184)的保护作用。还在很多疾病模型中广泛研究了膳食多酚和富含多酚的植物,并且公开的数据表明它们的存在可能在预防由于氧化应激引起的组织损伤中发挥重要作用,并且因此可能具有抗变态反应的潜力。
例如,Zürcher等人,2010,Clinic Exp Allergy,40(6):942-50公开了富含多酚的苹果提取物减弱了小鼠中的食物变态反应。因此,食用特别是富含黄酮醇的苹果提取物减轻了食物变态反应发作时的症状。Lee等人,2010,Inflamm Res 59:847-854公开了特别是黄酮醇槲皮素和莰非醇抑制体外系统中IgE介导的变态反应性炎症。已经研究了茶提取物在动物模型的皮肤炎症中的功效(Camouse等人,2009,Exp Dermatol 18:522-526)。而且,报道了乌龙茶(一种传统的中国茶)具有抗变态反应的活性(Ohmori等人,1995,Biol PharmBull 18:683-686)。茶提取物特别富含黄烷醇例如儿茶素、表儿茶素和它们的衍生物。发现表-棓儿茶素棓酸酯(EPCG)是茶提取物中的活性成分,其提供对抗皮肤炎症的保护作用(Katiyar等人,1995,Photochem Photobiol 62:855-861)。
还研究了多酚对于呼吸道变态反应的作用。Nauta等人,2008,Eur J Pharmacol585:354-360)公开了绿茶和某些分离的多酚对变态反应的效应细胞例如肥大细胞和嗜碱性粒细胞的体外作用。因此,EGCG被鉴定为有效的抑制剂。
通常,植物材料的天然提取物例如来自苹果或茶,仅包含少量目前鉴定的那些活性成分。这可能使得向需要的患者实际应用例如有效日剂量的那些提取物变得困难。
而且,从被证实具有预防或减轻变态反应的症状的潜力的食物级材料中分离的天然化合物的选择仍然非常有限。为了比较和评估它们各自的活性,为了优化和强化含有这些活性化合物的组合物的作用,以及为了最终向需要的患者提供可以作为天然每日膳食部分的方案,了解更多这类化合物是有利的。
仍需要发现新的和备选的化合物,用于预防和减轻变态反应性障碍或变态反应的症状,而没有以上提及的一些不适(inconvenience)和/或用于补充已经存在的活性成分的选择。特别地,长期食用时,新的方案不应当具有不利的健康或副作用,并且化合物应当理论上可以从天然来源获得,并且总之,其使得作为每日膳食部分以足够高剂量(起效)被个体食用是实用且可行的。
发明内容
发明概述
本发明的目的是改善技术状态,并且提供新的和备选的方案,用于预防和/或减轻变态反应性障碍或变态反应的症状。
本发明的目的是通过独立权利要求的主题实现的。从属权利要求进一步发展了本发明的想法。
因此,第一方面本发明提供了表儿茶素,用于预防或减轻变态反应性障碍和/或变态反应的症状。
因此,变态反应性障碍和/或变态反应的症状涉及“二级预防变态反应”(Prevention of Allergy and Allergic Asthma,World Health Organization,2003;WHO/NMH/MNC/CRA/03.2.)。
本发明的一个优点是它提供早的治疗或预防变态反应性障碍和/或变态反应的症状,即在二级预防框中,而很多现存的治疗仅提供三级预防。
WHO区分了一级、二级和三级预防。
一级预防是预防免疫敏化(即IgE抗体的产生)。
二级预防是预防敏化后变态反应性疾病的发生,并且特别是特应性湿疹/特应性皮炎、上呼吸道变态反应和变态反应性哮喘的发生。
三级预防是治疗哮喘和变态反应性疾病。
“二级预防变态反应”是调节变态反应症状的作用,即当患者再次暴露于所述的变应原时,在已经对一种或数种变应原敏化的患者中变态反应的发生或强度。通过调节变态反应症状的发生或强度,最小化与变态反应相关的不适。
多酚是具有抗氧化活性的一大组小化合物,其通常存在于植物和水果中。类黄酮是具有共同结构特征的这些多酚的亚组,它们自身可以进一步亚分组为例如黄酮醇、黄烷醇、黄酮、黄烷酮和其它。已经证实例如苹果和绿茶中包含的化合物对变态反应具有一般作用。苹果富含多种多酚,包括槲皮素和根皮苷(phlorizidin);绿茶富含不同的黄烷醇,包括原花青素和儿茶素和表儿茶素的棓酸化的衍生物。因此,已经发现特别是槲皮素和表棓儿茶素棓酸酯(EGCG)是活性成分,其提供了对抗炎症和对抗变态反应的保护。目前本发明人惊讶地发现黄烷醇表儿茶素能够减轻或预防变态反应性障碍和/或变态反应的症状。因此下面实施例部分提供了进行小鼠体内研究的证据。
目前有利的是富含表儿茶素的植物或水果提取物或补充表儿茶素的提取物或自身分离的或合成形式的表儿茶素可以用于预防或减轻变态反应性障碍或变态反应的症状。预期适量使用表儿茶素没有例如由强皮质类固醇或抗组胺活性引起的不希望的副作用。而且,可以制备植物或水果提取物,其一方面有效用于减轻变态反应症状,另一方面食用仍可口。现在还可能提供具有适合浓度的活性成分表儿茶素的提取物,其可以例如作为每日膳食部分被消费者以每天合理且可行的量食用。
附图简述
图1:所用的食物变态反应模型的示意图。
图2:所研究的不同苹果提取物中表儿茶素的浓度。
图3:用具有和不具有高浓度的表儿茶素的苹果提取物处理小鼠的变态反应症状试验结果。
图4:用富含表儿茶素的可可提取物处理小鼠的变态反应症状试验结果。
图5:用化学纯的表儿茶素处理小鼠的变态反应症状试验结果。
发明详述
本发明涉及用于预防或减轻变态反应性障碍和/或变态反应症状的表儿茶素,其中变态反应性障碍选自皮肤变态反应、变态反应接触性皮炎、食物变态反应、变态反应性鼻炎或哮喘。
对于易感个体,变态反应可以从婴儿早期开始,即例如皮肤变态反应,例如特应性湿疹、限制为或随后发展成食物变态反应,例如对抗某些牛乳蛋白质、卵和小麦蛋白质、坚果或贝。呼吸道变态反应例如变态反应性鼻炎和变态反应性哮喘发生在以后的生活中。变态反应表示对环境(例如粉尘螨或植物花粉)中或食物(例如乳、蛋、坚果)中正常存在的多种变应原的失调的免疫应答。
术语“皮肤变态反应”在本文表示皮肤痒和疹。一种形式的皮肤变态反应通常是特应性皮炎(湿疹),其通常发生在幼儿中。它还可以在年轻成人中开始,并且可以持续到成年生活。皮肤变态反应下包括的其它是荨麻疹,也常称为风疹,其是可以在任何年龄发生的痒疹。
术语“变态反应接触性皮炎”在本文表示接触性皮炎,其是由皮肤与引起疹样反应的物质接触所导致的。人对多种化学品有反应,所述的化学品包括化妆品、染发剂、金属、局部药物、牙科材料和植物,例如毒漆树科的植物。这类接触性变态反应发生在所有年龄的人或动物中。
术语“食物变态反应”在本文表示对食物、特别是食物蛋白质的不利的免疫应答。触发变态反应的已知的最常见的食物是乳、蛋、花生、树坚果(tree nuts)、鱼、贝、大豆和小麦。这些食物变应原中的一些可以随着年龄变得消失(outgrown),但是一些例如花生和贝对于个体可能保持终生变态反应。食物变态反应的症状范围可以从局部免疫反应例如嗜酸性食管炎或全身显现为发绀、腹泻、体温过低和过敏反应。
术语“变态反应性鼻炎”,也常称为花粉病或枯草热,在本文表示鼻气道的变态反应性炎症,并且特征在于鼻塞和流鼻水、喷嚏和痒。眼症状例如眼红和含泪眼也是表现。当敏化的免疫系统的个体吸入变应原例如花粉或粉尘螨时变态反应性鼻炎就发生了。在这类个体中,变应原触发抗体免疫球蛋白E(IgE)产生。
术语“哮喘”在本文表示下气道的常见慢性炎性疾病,并且特征在于喘鸣、粘液产生和肺功能损伤。
表儿茶素用于本发明的用途,其中症状可以是肠不适、腹泻、呕吐、皮肤刺激、特应性湿疹、呼吸道刺激、眼刺激或其组合。
表儿茶素的作用更特别的是对二级预防变态反应的作用。在下面描述的实施例的小鼠模型中,变态反应的症状确实显著减轻,如更低的变态反应临床得分所说明的。通常,症状可以包括所有的通常认为的变态反应症状或通常认为的变态反应症状的选择。这些症状包括皮肤的(皮肤发红、疹、痒、皮炎、湿疹)、眼的(痒和含水眼)、胃肠道的(充血、腹痛、痉挛、呕吐、腹泻)、呼吸道的(鼻痒、喷嚏、鼻充血、鼻炎、哮喘)和在严重情况中全身性的(头晕、精神错乱、不能移动、过敏反应)现象。
发明人已经证实当为敏化的年轻哺乳动物提供富含表儿茶素的提取物或分离形式的表儿茶素时,变态反应和症状可以缓解。动物模型模拟人的食物变态反应,当人,通常是婴儿或幼儿,天生对食物变应原敏化时。这定义了表儿茶素对二级预防变态反应的正面作用。
因此,在本发明的一个优选的实施方案中,变态反应性障碍和/或变态反应可以是食物变态反应。
表儿茶素被施用于人或宠物,特别是猫或狗。
表儿茶素可以被施用于所有年龄的人。然而,有利地,表儿茶素在变态反应及其症状开始显现时尽可能快地施用于患者,即在很多情况下已经在生命的早期。因此,人优选是年龄为4个月至6岁的幼儿或年龄至多18岁的大龄儿童或成年人。
在一个备选的实施方案中,表儿茶素旨在被动物、优选猫或狗食用。类似于人,在动物,特别是家养动物和作为宠物饲养的动物中可以观察到变态反应和此类变态反应的症状。有利的是本发明提供了可以由它的主人提供给伴侣动物的方案。
表儿茶素是以范围每天25mg至10g、每天50mg至10g、优选每天100mg至5g、甚至更优选每天300mg至1g的量施用于人。这些优选的剂量一方面为相关的患者每天提供了足够的表儿茶素,以提供预期的健康益处,另一方面,不提供过量的表儿茶素,以防止对患者任何潜在不希望的或有毒作用的风险。
在一个实施方案中,表儿茶素是以植物提取物或浓缩物形式提供的。这提供了天然形式和环境的表儿茶素,但是是浓缩状态。因此,表儿茶素是天然来源,并且可以以食物产品提供,其是消费者公认的并且受到消费者欢迎,并且仍为其提供必需量的活性表儿茶素。另一个优点是表儿茶素无需以纯化的形式(例如通过化学合成)首先制备,因此还提供了为消费者提供表儿茶素的更经济的方案。
有利的是,表儿茶素是以植物提取物形式提供的,其天然地已经包含基本水平的表儿茶素,并且其很受消费者喜欢。因此,植物提取物或浓缩物可以优选是苹果、可可或茶的提取物或浓缩物。
在一个优选的实施方案中,表儿茶素是以包含至少0.1wt%、优选至少1wt%的表儿茶素的组合物形式提供的。或者,表儿茶素是以包含至少10wt%、例如至少20wt%或40wt%的组合物的形式提供的。因此,通过浓缩其中已经天然存在的表儿茶素或为组合物补充例如富含表儿茶素的植物提取物或合成制备的表儿茶素,组合物可以富含表儿茶素。有利的是,产生的组合物包含一定量的表儿茶素,当正常、可行的每日食用所述的组合物(例如作为食物产品的部分)时,该量是有效的。因此,例如包含0.1至1wt%的表儿茶素的组合物可以很好适合作为常规膳食的部分提供给幼儿的组合物。或者,成年人可能优选更多的表儿茶素浓缩的组合物,其可以在用餐之间食用,而不是作为常规膳食的部分。
用于本发明用途的表儿茶素是以组合物的形式提供的,其是食物产品、食物补充剂或药物产品。
在一个优选的实施方案中,食物产品选自婴儿喂食组合物、后续配方食品、成长乳、婴儿谷物或婴儿食物产品。这些产品特别好地适合于满足和解决预防或减轻婴儿和幼儿中变态反应症状的问题。
在进一步的实施方案中,食物产品选自饮料产品、酸乳酪产品、发酵乳、果汁或谷物棒。这些食物产品很好地适合于向更大的儿童和成年人施用表儿茶素。该食物产品可以很好地富含表儿茶素,并且具有可信表象来为消费者提供健康定向的功能食物产品。
对于减少变态反应症状的产品,一个特别需要可能是临床环境,例如在医院、诊所和老年人之家中。因此,在进一步的实施方案中,食物产品是用于特别的医学目的的食物,例如口服喂食的保健食物产品,和/或肠内喂食的营养产品。本发明的优点在于活性成分表儿茶素可以以相对高的局部浓度和低体积的医学食物产品提供,因此可以有效地施用于需要的患者。
在进一步的实施方案中,食物产品是宠物食物产品。
本领域的那些技术人员将理解他们可以自由地组合本文公开的本发明的所有特征。特别的是,可以组合本发明不同实施方案描述的特征。通过附图和实施例,本发明的进一步的优点和特征变得显而易见。
具体实施方式
实施例1:卵白蛋白(OVA)食物变态反应小鼠模型
如图1示意所示,将六周龄常规BALB/c小鼠通过口服途经(用管饲针针)敏化,第一周应用3次,然后在7周期间每周间隔应用20mg购自Sigma(瑞士)的卵白蛋白(OVA)加10μg/小鼠的购自LuBioscience(Lucerne,瑞士)的霍乱毒素(用作辅剂)。将作为纯分离的多酚或植物或水果提取物中富含的表儿茶素以剂量范围0.1%至1%掺入到食物中,并且在试验最后一周给予敏化的小鼠。最后敏化后1周,通过用100mg OVA管饲进行口服激发。在激发当日,将小鼠在激发前禁食2小时。激发后30分钟,将小鼠各自观察30分钟。记录临床症状,并且如下定量(变态反应得分):0)没有症状,搔抓发作少于4次;1)鼻子和头周围搔抓发作4-10次,没有腹泻;2)搔抓发作大于10次或软便;3)腹泻或呼吸吃力或发绀或者存在两个或多个症状(搔抓和软便);4)腹泻组合刺激后不能移动、皮毛直立、呼吸吃力或发绀;5)过敏反应。激发后4小时,处死小鼠。
实施例2:用具有和不具有高水平表儿茶素的苹果提取物的变态反应症状试验
在试验的最后一周期间,将具有不同浓度的表儿茶素的苹果提取物(图2)以1wt%掺入到敏化的小鼠的膳食(Kliba 3200,Kliba Nafag Kaiseraugst,瑞士)中。膳食是在敏化期结束时开始提供,并且小鼠接受含有苹果提取物的膳食一共8天。在第50天激发后,相比对照敏化的未处理的动物(阳性对照),用含有表儿茶素的苹果提取物处理的小鼠出现的严重临床症状更少。然而,接受不含表儿茶素的苹果提取物的敏化的小鼠的变态反应症状没有减轻。图3说明了该结果。
实施例3:用富含表儿茶素的可可提取物的变态反应症状试验
在变态反应症状模式试验的最后一周期间,以实施例2中苹果提取物的相同方式将富含表儿茶素的可可提取物以占膳食1wt%浓度施用于敏化的小鼠。在第50天激发后,相比对照敏化的、未处理的动物(阳性对照),用含有表儿茶素的可可提取物处理的小鼠出现的严重临床变态反应症状显著更少。图4说明了该结果。
实施例4:用不同浓度的纯表儿茶素的变态反应症状试验
在变态反应症状模型的最后一周期间,以实施例2中苹果提取物的相同方式将化学纯的表儿茶素(Sigma,瑞士)以剂量范围0.1至1wt%以膳食施用于敏化的小鼠。在第50天激发后,相比敏化的、未处理的动物(阳性对照),用占膳食0.1%和1%浓度的多酚表儿茶素处理的小鼠出现的严重临床变态反应症状显著更少。图5说明了该结果。
Claims (15)
1.表儿茶素在制备用于二级预防变态反应性障碍和/或变态反应的药物中的用途。
2.权利要求1的用途,其中变态反应性障碍选自皮肤变态反应、变态反应接触性皮炎、食物变态反应、变态反应性鼻炎或哮喘。
3.权利要求1或2的用途,其中二级预防是减轻或预防变态反应性障碍和/或变态反应的症状,其中症状是肠不适、腹泻、呕吐、皮肤刺激、特应性湿疹、呼吸道刺激、眼刺激或其组合。
4.上述权利要求任意一项的用途,其中表儿茶素被施用于人或宠物,特别是猫或狗。
5.权利要求4的用途,其中人是年龄为4个月至6岁的幼儿,年龄为6至18岁的大龄儿童,或成年人。
6.权利要求4或5的用途,其中表儿茶素以范围为每天25mg至10g、优选每天100mg至5g,甚至更优选每天300mg至1g的量施用于人。
7.上述权利要求任意一项的用途,其中表儿茶素是以植物提取物或浓缩物的形式提供的。
8.权利要求7的用途,其中植物提取物或浓缩物是来自苹果、可可或茶的提取物或浓缩物。
9.上述权利要求任意一项的用途,其中表儿茶素是以含有至少0.1wt%、优选至少1wt%的表儿茶素的组合物形式提供的。
10.上述权利要求任意一项的用途,其中表儿茶素是以含有至少10wt%、20wt%或40wt%的表儿茶素的组合物形式提供的。
11.权利要求9或10的用途,其中组合物是食物产品、食物补充剂或药物产品。
12.权利要求11的用途,其中食物产品选自婴儿喂食组合物、后续配方食品、成长乳、婴儿谷物或婴儿食物产品。
13.权利要求11的用途,其中食物产品选自饮料产品、酸乳酪产品、发酵乳、果汁或谷物棒。
14.权利要求11的用途,其中食物产品是用于特别的医学目的的食物,例如口服喂食的保健食物产品、肠内喂食的营养产品或非肠道喂食的产品。
15.权利要求11的用途,其中食物产品是宠物食物产品。
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