CN101553137B - 具有高多酚含量的苹果 - Google Patents
具有高多酚含量的苹果 Download PDFInfo
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- CN101553137B CN101553137B CN200780037439.XA CN200780037439A CN101553137B CN 101553137 B CN101553137 B CN 101553137B CN 200780037439 A CN200780037439 A CN 200780037439A CN 101553137 B CN101553137 B CN 101553137B
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- Prior art keywords
- fructus mali
- mali pumilae
- polyphenol
- formula
- disease
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Abstract
本发明涉及含高浓度多酚的苹果、得到所述苹果的方法和这些苹果作为治疗或预防心血管疾病、结肠癌和帮助消化健康方法的用途。
Description
本发明涉及含高浓度多酚的苹果、得到所述苹果的方法和这些苹果作为治疗或预防心血管疾病、结肠癌和帮助消化健康方法的用途。
心血管疾病(CVD)和癌症是全世界死亡的两个主要原因。
在欧盟,CVD是发病和死亡的主要来源,每年花费1690亿欧元(Leal et al.(2006)Eur.Heart J.27(13):1610-9),而在美国,据美国心脏协会估计,71,300,000名美国人患有一种或多种形式的CVD。
据世界卫生组织称,癌症每年导致全世界约760万(或13%)人死亡。尤其是,肺癌、胃癌、肝癌、结肠癌和乳腺癌是这些死亡中一半以上的来源。
流行病学证据似乎提示,富含水果和蔬菜的饮食提供对预防这些慢性疾病的显著保护作用。这种保护作用中的许多因素与在水果和蔬菜中发现的称为多酚的一大类植物化学物质有关。
多酚称为自然生物反应调节剂,因为强有利的实验证据证明它们调节身体对过敏原、病毒和致癌原的反应能力。它们显示抗过敏、抗炎、抗微生物和抗癌活性。另外,多酚还起强抗氧化剂的作用,防止氧化剂和自由基损害,有助于预防与氧化性应激有关的各种疾病。
但据估计,多数人未消耗可得到由多酚提供的健康益处的足够量。例如,目前平均每个美国人日摄取表儿茶素比减少CVD风险所需推荐剂量低2-4倍(Gu et al.(2004)JNutr 134(3):613-7;Prior and Gu(2005)Phytochemistry 66(18):2264-80)。因此,通过食物增加摄取量已成为一个重要的健康目标。
苹果可为多酚的重要来源,它提供减少CVD风险所需推荐剂量约10%(Gu et al.(2004)同上)。但是,多酚的浓度和分布在各品种中差异极大(参见表1)。许多现代甜点中苹果的多酚含量的确可能小于1000mg/kg。
因此,本发明目的是提供具有增加的多酚水平的苹果。
因此,按照本发明的一个方面,提供含总多酚含量大于5000mg/kg的苹果。
按照本发明的第一个方面,提供含总多酚含量大于10000mg/kg的苹果。
在一个实施方案中,多酚含量为10000-100000mg/kg。在另一个实施方案中,多酚含量为10000-50000mg/kg。因此,这些苹果中多酚浓度比任何其它报道的鲜重来源的浓度高得多。因此,它们可在人们的食物中提供大量食物来源的多酚,从而为消费者提供与增加的多酚摄取有关的健康益处。可认识到,本文中所述“多酚含量”是指鲜重含量。干重含量的当量范围将比存在的鲜重含量高约5-7倍。
在一个实施方案中,苹果包括″通红(red-cut through)″苹果。可以认识到,术语″通红″在本领域中熟知,是指具有红果肉的苹果。
当本文中使用时,术语多酚是指特征在于每个分子中存在大于一个苯酚基团的一组化学物质。在一个实施方案中,多酚包括亚组类黄酮。
已在各种植物中表征出5000种以上的天然类黄酮。按照化学结构将它们分类,可分为不同的亚类。在一个实施方案中,类黄酮包括:
(a)黄烷酮(例如橙皮素、柚苷配基、圣草酚),它们基于式(I)所示化学骨架:
(b)异黄烷酮(例如金雀异黄素、黄豆苷元、黄豆黄素),它们基于式(II)所示化学骨架:
(c)黄酮(例如藤黄菌素、芹黄素、柑桔黄酮),它们基于式(III)所示化学骨架:
(d)黄酮醇(例如栎精、莰非醇、杨梅黄酮、异鼠李亭、藿香黄酮醇、鼠李金),它们基于式(IV)所示化学骨架:
(e)黄烷-3-醇(例如儿茶素、棓儿茶素、表儿茶素、表棓儿茶素),它们基于式(V)所示化学骨架:
(f)黄烷-3,4-二醇,它们基于式(VI)中所示化学骨架:
(g)二氢黄酮醇,它们基于式(VII)所示化学骨架:
(h)花色素(例如花青素、翠雀色素、锦葵花素、花葵素、芍药素、矮牵牛配基),它们基于式(VIII)所示化学骨架:
(i)花色素苷,它们基于式(IX)所示化学骨架:
其中糖可选自葡萄糖、阿拉伯糖、半乳糖等。
在一个实施方案中,类黄酮包括原花色素。原花色素是由黄烷-3-醇亚基组成的生物聚合物。聚合物主要通过4和8位以及4和6位连接。在另一个实施方案中,原花色素是4,8位连接的聚合物,该聚合物具有式(X)所示结构:
在一个实施方案中,类黄酮包括花色素、原花色素、黄烷醇、黄酮醇、黄酮、黄烷酮和异黄酮。在另一个实施方案中,类黄酮包括黄烷醇和原花色素。
在一个实施方案中,黄烷-3-醇具有式(V)a所示结构:
其中R1代表氢或OH基团。
在一个实施方案中,黄烷-3-醇具有式(V)b所示结构:
其中R1定义同上。
其中R1代表氢的式(V)b化合物称为表儿茶素,其中R1代表OH基团的式(V)b化合物称为表棓儿茶素。
在一个实施方案中,黄烷-3-醇具有式(V)c所示结构:
其中R1定义同上。
其中R1代表氢的式(V)c化合物称为儿茶素,其中R1代表OH基团的式(V)c化合物称为棓儿茶素。
在一个实施方案中,花色素包括具有式(VIII)a所示结构的花青素:
在一个实施方案中,类黄酮包括具有式(VIII)b所示结构的翠雀色素:
在一个实施方案中,原花色素具有式(X)a所示结构:
其中R1定义同上;和
n=2-30。
在一个实施方案中,n>10(即11-30)。在另一个实施方案中,式(X)a化合物的分子量大于1000。在再另一个实施方案中,式(X)a化合物的分子量>1000且<9000(例如>3000且<9000)。
原花色素包括原花青素和原翠雀色素亚组,酸水解后,这些物质分别生成花青素和翠雀色素。
治疗方法
本发明多酚证明具有许多健康益处。例如,流行病学研究提示较高的类黄酮摄取与减少的CVD风险有关(Arts et al(2001)Epidemiology 12(6):668-675;Sesso et al.AmJ Clin Nutr 77:1400-8;Mink et al.(2007)Am J Clin Nutr 85(3):895-909),这可能是它们具有在人体中改善内皮功能和抑制血小板凝集的能力的原因(Keen et al.(2005)AmJ Clin Nutr 81(1 Suppl):298S-303S;Vita J A(2005)Am JClin Nutr 81(Suppl):292S-7S;Heptinstall et al.(2006)J CardiovascPharmacol 47 Suppl 2:S197-205)。
但是,最新证据提示分子量大于600的分子在小肠中很少被吸收到血流中,因为它们太大以致无法通过肠壁。例如,在人研究中测得的儿茶素和表儿茶素的Tmax值表明这些小分子量化合物主要在小肠中吸收(Donovan et al.,(1999),J.Nutr.,129(9),1662-1668;Richelle et al.(1999)Eur.J.Clin.Nutr.53(1):22-26;Lee et al.(2002),CancerEpidemiol.Biomark.Prev.,11(10 Pt 1):1025-1032)。另外,显示(+)-儿茶素单体具有与(-)-表儿茶素单体相比相对低的生物利用度(Shoji T etal.(2006)J Agric FoodChem.54(3):884-92)。
尽管在人血浆中检测到低水平的原花青素B1(表儿茶素-(4β-8)-儿茶素)和B2(表儿茶素-(4β-8)-表儿茶素),但低聚和聚合原花色素似乎未显著地吸收到小肠中。消耗巧克力后,在血浆中检测不到二聚体B5(表儿茶素-(4β-6)-表儿茶素)(Holt et al.,(2002),Am.J.Clin.Nutr.,76,798-804)。没有研究在血浆中检测到聚合度大于四聚体的原花色素。因此,原花青素低聚物和聚合物(式(X)a化合物,其中n>2)说明吸收到小肠中的多酚小于10%,因此不可能是导致减少的CVD风险的因素(Déprez et al.,(2001),Antioxidantsand Redox Signalling,3,957-967;Shoji et al(2006)同上)。最新试验的确显示CVD风险减少与使用原花色素无必然关系(Williamson et al(2005)Am J Clin Nutr.81(1Suppl),243S-255S)。
而据认为,这些分子通过结肠时极少分解(Rios,L.et al.,(2002)Am.J.Clin.Nutr.,76,1106-1110)。在该阶段,它们可被肠微生物区系消化,为此它们用作有效的益生元类物质,或它们可抑制结肠癌。发现苹果原花青素(式(X)a化合物)在实验动物中显著减少结肠中癌前损害的数目(American Association for Cancer Research,Third AnnualInternational Conference),而苹果原花青素(式(X)a化合物,其中n>9)使存活的结肠癌细胞减少82%(Kroon et al.(2004)Am J Clin Nutr80(1):15-21),支持该结论。
因此,根据该发现,将多酚分离为低分子量多酚和高分子量多酚是适当的。
在一个实施方案中,低分子量多酚含单体(式(I)-(IX)化合物)和二聚体(式(X)a化合物,其中n=2),它们的分子量小于600。在另一个实施方案中,低分子量多酚含分子量小于300的单体(式(I)-(IX)化合物)。
在一个实施方案中,低分子量多酚的浓度包括大于22%的总多酚含量。在一个实施方案中,低分子量多酚的总多酚含量为22%-40%。在另一个实施方案中,低分子量多酚的总多酚含量为22%-40%,其中至少85%,例如至少90%,例如至少95%,例如至少99%低分子量多酚含式(V)a化合物。
在再另一个实施方案中,低分子量多酚的总多酚含量为22%-40%,其中至少85%,例如至少90%,例如至少95%,例如至少99%低分子量多酚含式(V)b化合物,其中R1代表氢(例如表儿茶素-α异构体)。
在一个实施方案中,高分子量多酚含低聚物和聚合物(式IV化合物,其中n>2),它们的分子量大于600。在另一个实施方案中,高分子量多酚含低聚物和聚合物(式IV化合物,其中n>1),它们的分子量大于300。
因此相信,低分子量多酚可代表有效预防或治疗心血管疾病。另外,还相信高分子量多酚可构成对结肠癌的有效预防或治疗。
可以认识到,因为前文中定义的苹果含有这种大量的两种类型的此类多酚,它们很可能具有有效预防或治疗心血管疾病或结肠癌的能力。
还可以认识到,可通过本领域技术人员熟知的方法,由所述苹果例如苹果片、苹果果肉、苹果汁等制备多种苹果提取物和各种干提取物。因此,这些得到的苹果提取物通常含高浓度多酚。因此,在本发明的一个方面,提供由前文定义的苹果制备的苹果提取物,该提取物含多酚。这种苹果提取物很可能具有类似于该苹果的疗效。
还会认识到,可通过本领域技术人员熟知的方法,从所述苹果分离一种或多种多酚。这种多酚分离物将具有前文中所述疗效。
因此,按照另一方面,提供前文定义的用于预防或治疗心血管疾病或结肠癌的苹果、苹果提取物或多酚分离物。
在另一方面,提供前文定义的苹果、苹果提取物或多酚分离物在制备药物中的用途,该药物用于预防或治疗心血管疾病或结肠癌。
在本发明的再另一方面,提供治疗或预防心血管疾病或结肠癌的方法,该方法包括给予前文定义的苹果、苹果提取物或多酚分离物。
在本发明的再另一方面,提供药用组合物,该组合物含用于预防或治疗心血管疾病或结肠癌的苹果、苹果提取物或多酚分离物。
可以认识到,本文使用的术语“治疗”表示目的为抵抗病症例如疾病或障碍,而对患者进行的处理和照顾。该术语将包括对患者患有给定病症的所有治疗范围,例如给予活性化合物,用以缓解症状或并发症,延迟疾病、障碍或病症的发展,缓解或减轻症状和并发症,和/或治愈或消除疾病、障碍或病症以及预防病症,其中预防可理解为目的为抵抗疾病、病症或障碍而对患者进行的处理和照顾,它包括给予活性化合物,用以防止症状或并发症发作。所治疗的患者优选为哺乳动物,尤其是人类,但它也可包括动物,例如狗、猫、母牛、绵羊、马和猪。
联合疗法
在治疗中通过同时或序贯给予,用大于一种药物治疗多种疾病。因此,在用于治疗上述疾病之一的治疗方法中,本发明苹果、提取物或多酚分离物互相联合使用,或作为通常用于治疗所述疾病的其他公认疗法的辅助疗法,或与通常用于治疗所述疾病的其他公认疗法联合使用均在本发明范围内。在一个实施方案中,提供药用组合物,该组合物含前文定义的苹果、提取物或多酚分离物和组合应用的一种或多种另外的治疗药物。
以此类推,在制备治疗所述疾病的药物中,本发明苹果、提取物或多酚分离物和通常用于治疗上述疾病之一的其它治疗活性化合物组合使用,也在本发明范围内。
可按本领域技术人员认为必需或便利的任何方式且为了本说明书的目的,进行联合治疗,关于化合物用于组合的次序、量、重复或相对量认为不受限制。
合成方法
因此,本发明还提供得到前文定义的苹果的方法,该方法包括使通红(red-through)仁果与苹果杂交的步骤。
可以认识到,所述″通红仁果″是指具有红果肉的水果,且其由蔷薇科(rosaceae)中苹果亚科(maloideae)的开花植物生产。此类通红仁果的实例包括酸苹果(crabapple)(苹果属)和山楂(山楂属;例如锐刺山楂(Crataegus oxyacantha))。在一个实施方案中,通红仁果是山楂(山楂属;例如锐刺山楂(Crataegus oxyacantha))。由山楂制备本发明苹果的优点是山楂果直径通常小于20mm,具有高的表面积:体积比例,因此较易冻干。所以,山楂果可在得到的苹果中提供高浓度多酚,因此被推荐为心血管疾病的天然疗法(Walker,A.F.et al.,(2002)Phytother Res.16,48-54)。
可以认识到,可使通红仁果与任何合适的苹果杂交。苹果的选择将主要取决于得到的苹果的需要的性质(例如甜度、坚度等)。在一个实施方案中,使通红仁果与酸苹果(苹果属)杂交。
通常,本发明方法将需要在各阶段干预。例如,杂交步骤后,通常应在得到的苹果上进行多酚剖面测量(profiling),直至它们可分为以下3类之一:
(1)特征在于总多酚含量为10,000-20,000mg/kg,更典型12,000-14,000mg/kg(按鲜重计)的水果;
(2)特征在于总多酚含量为20,000-100,000mg/kg,更典型15,000-40,000mg/kg(按鲜重计)的水果;和
(3)特征在于总多酚含量最高达10,000mg/kg,更典型9,000-10,000mg/kg(按鲜重计)的水果。
通常,一旦将苹果归类到上述3类中之一,本发明方法然后将需要繁殖步骤,以得到活的苹果。
组合物
在一个实施方案中,本发明高分子量多酚可与其它益生元类物质例如单糖、二糖和多糖组合使用。因此,按照本发明的另一个方面,提供益生元组合物,该组合物含一种或多种高分子量多酚;一种或多种单糖、二糖或多糖。合适的糖是具有式(XI)所示结构的低聚果糖:
其中n通常为2-14,适合为2-10,例如2-8。
在另一个实施方案中,本发明高分子量多酚可与苹果提取物组合使用,该苹果提取物提供各种单糖、二糖和多糖。
当多酚与其它益生元类物质或苹果提取物组合使用时,可通过任何便利途径序贯或同时给予各组分。该组合提供刺激微生物区系的优点,其帮助改善肠健康、肠功能、钙吸收和免疫反应,以及还减少结肠癌风险(Rios,L.et al.同上)。
在一个方面,本发明提供剂型,该剂型含苹果提取物或多酚分离物和/或上述组合(下文中称为本发明组合物)。
可便利地将本发明组合物单独给予或与药学上可接受的载体或赋形剂组合给予。可按照常规技术例如在Remington:The Science andPractice of Pharmacy,第19版,Gennaro,Ed.,Mack Publishing Co.,Easton,PA,1995中公开的那些,用药学上可接受的载体或稀释剂和任何其它已知助剂和赋形剂配制本发明组合物。
合适的药物载体包括惰性固体稀释剂或填充剂、无菌水溶液和各种有机溶剂。固体载体的实例为乳糖、石膏粉、蔗糖、环糊精、滑石粉、明胶、琼脂、果胶、阿拉伯胶、硬脂酸镁、硬脂酸和纤维素的低级烷基醚。液体载体的实例是糖浆、花生油、橄榄油、磷脂、脂肪酸、脂肪酰胺、聚氧乙烯和水。
同样,载体或稀释剂可包括任何本领域中已知的缓释材料,例如单独或与蜡混合的甘油单硬脂酸酯或甘油二硬脂酸酯。然后容易用适合公开的给药途径的多种剂型给予通过使本发明组合物与药学上可接受的载体混合形成的药用组合物。可通过药剂领域中已知的方法,将制剂便利地制成单位剂量形式。
因此,在另一个方面,提供用于治疗心血管疾病的剂型,该剂型含一种或多种低分子量多酚或其药学上可接受的盐或前药,和一种或多种药学上可接受的载体、赋形剂或稀释剂。
因此,在另一个方面,提供用于治疗结肠癌的剂型,该剂型含一种或多种高分子量多酚或其药学上可接受的盐或前药,和一种或多种药学上可接受的载体、赋形剂或稀释剂。
可配制剂型,用于通过任何合适的途径例如口服、直肠、鼻、肺、局部(包括含服和舌下)、透皮、脑池内、腹膜内、阴道和肠胃外(包括皮下、肌内、鞘内、静脉内和皮内)途径给药,优选口服途径。可以认识到,优选的途径将取决于所治疗的患者的一般状况和年龄、所治疗的病症性质和所选择的活性成分。
对于局部使用,考虑含本发明化合物的喷雾剂、霜剂、软膏剂、胶冻剂、凝胶剂、吸入剂、皮肤贴剂、植入剂、混悬液等。对于该申请的目的,局部应用将包括漱口水和含漱剂。
口服给药组合物包括固体剂型例如硬或软胶囊剂、片剂、软锭剂、糖锭剂、丸剂、硬锭剂、散剂、颗粒剂;和液体剂型例如溶液、乳液、水或油混悬液、糖浆和酏剂,它们各自含预定量的本发明组合物,并可含合适的赋形剂。可按照任何已知方法制备将口服用的组合物,此类组合物可含一种或多种选自以下的物质:甜味剂、矫味剂、着色剂和防腐剂,以便提供药品美观和爽口制剂。
水性混悬剂可含与适合制备水性混悬剂的赋形剂混合的本发明组合物。此类赋形剂是悬浮剂例如羧甲基纤维素钠、甲基纤维素、羟丙基甲基纤维素、藻酸钠、聚乙烯吡咯烷酮、黄芪胶和阿拉伯胶;分散剂或湿润剂可以是天然磷脂例如卵磷脂,或环氧烷与脂肪酸的缩合产物例如聚氧乙烯硬脂酸酯,或环氧乙烷与长链脂族醇的缩合产物例如十七碳亚乙基氧基鲸蜡醇,或环氧乙烷和由脂肪酸和己糖醇衍生的部分酯的缩合产物例如聚氧乙烯山梨醇单油酸酯,或环氧乙烷和由脂肪酸和己糖醇酐衍生的部分酯的缩合产物例如聚乙烯脱水山梨醇单油酸酯。水性混悬剂也可含一种或多种着色剂、一种或多种矫味剂和一种或多种甜味剂例如蔗糖或糖精。
油性混悬剂可通过将本发明组合物悬浮于植物油例如花生油、橄榄油、芝麻油或椰子油,或悬浮于矿物油例如液体石蜡中配制。油性混悬剂可含增稠剂例如蜂蜡、硬石蜡或鲸蜡醇。可加入甜味剂例如上述那些和矫味剂,以提供可口的口服制剂。可通过加入抗氧化剂例如抗坏血酸保存这些组合物。
适合通过加入水制备水性混悬剂的可分散粉末和颗粒提供和分散剂或湿润剂、悬浮剂和一种或多种防腐剂混合的本发明组合物。合适的分散剂或湿润剂和悬浮剂已经通过上述那些举例说明。它们也可含缓冲剂例如柠檬酸盐和磷酸盐缓冲剂、由碳酸盐例如碳酸氢盐例如碳酸氢钠或碳酸氢铵和solic酸例如柠檬酸或柠檬酸盐形成的泡腾剂。其它赋形剂例如甜味剂、矫味剂和着色剂也可存在。
本发明药用组合物也可为水包油乳液形式。油相可以是植物油,例如橄榄油或花生油,或矿物油例如液体石蜡或其混合物。合适的乳化剂可以是天然胶例如阿拉伯胶或黄芪胶;天然磷脂例如大豆、卵磷脂;和由脂肪酸和己糖醇酐衍生的酯或部分酯例如脱水山梨醇单油酸酯;和所述部分酯和环氧乙烷的缩合产物例如聚氧乙烯脱水山梨醇单油酸酯。乳液也可含甜味剂和矫味剂。
可用甜味剂例如甘油、丙二醇、山梨醇或蔗糖配制糖浆和酏剂。此类制剂也可含缓和剂、防腐剂和矫味剂和着色剂。药用组合物可以为无菌可注射水性或油性混悬剂形式。该混悬剂可按照已知方法,用合适的上述分散剂或湿润剂和悬浮剂配制。无菌注射制剂也可以是在无毒肠胃外可接受的稀释剂或溶剂中的无菌注射液或混悬液,例如1,3-丁二醇的溶液。在可使用的可接受的溶媒和溶剂中有水、林格氏液和等渗氯化钠溶液。另外,无菌非挥发油可便利地用作溶剂或悬浮介质。为此目的,可采用使用合成甘油单酸酯或甘油二酸酯的任何非刺激性非挥发油。另外,脂肪酸例如油酸可用于注射剂的制备。
在另一个实施方案中,可将含多酚的流分和多酚分离物干燥。例如在低于30℃,例如低于20℃下,喷雾干燥或真空干燥,任选冻干,然后配制为固体剂型。
片剂可含和适合片剂制备的无毒的药学上可接受的赋形剂混合的活性成分。这些赋形剂可以为例如惰性稀释剂,例如碳酸钙、碳酸钠、乳糖、磷酸钙或磷酸钠;制粒剂和崩解剂例如玉米淀粉或藻酸;粘合剂例如淀粉、明胶或阿拉伯胶;和润滑剂例如硬脂酸镁、硬脂酸或滑石粉。
片剂可不包衣,或可通过已知技术将它们包衣,以延缓在肠胃道的崩解和吸收,从而在较长时间内提供持续作用。
口服用制剂也可以作为硬明胶胶囊提供,其中活性成分与惰性固体稀释剂例如碳酸钙、磷酸钙或高岭土混合;或作为软明胶胶囊提供,其中活性成分与水或油介质例如花生油、液体石蜡或橄榄油混合。
肠胃外给药剂型包括无菌水和非水注射溶液、分散体、混悬液或乳液,和用于临用前再形成无菌注射溶液或分散体的无菌粉末。如果需要,应将此类水溶液适当缓冲,并先用足量盐水或葡萄糖使液体稀释剂等渗。水溶液尤其适合静脉内、肌内、皮下和腹膜内给药。使用的无菌含水介质均可容易地通过本领域技术人员已知的标准技术得到。长效注射制剂也考虑在本发明范围内。
用于通过直肠给予化合物的组合物也可以是栓剂形式。可通过使本发明组合物与合适的非刺激性赋形剂混合,制备这些组合物,所述合适的非刺激性赋形剂在常温下为固体但在直肠温度下为液体,因此在直肠中将熔化,释放本发明组合物。此类材料包括例如可可豆脂和聚乙二醇。
通常按有效达到预定目的的量例如有效治疗或预防所治疗的具体疾病的量,使用本发明化合物或其组合物。可按治疗量给予化合物,获得治疗益处。治疗益处表示去除或缓解正在治疗的有关疾病和/或去除或缓解与有关疾病有关的一种或多种症状(system)。治疗益处还包括终止或延缓疾病发展,无论是否得到改善。
确切剂量将取决于给药的频率和模式、所治疗的患者的性别、年龄、重量和一般状况、所治疗病症的性质和严重程度、待治疗的任何伴发病,和本领域技术人员显而易见的其它因素。有效剂量的测定完全在本领域技术人员的能力之内。
当本发明化合物或其药学上可接受的盐、溶剂合物或前药与对相同疾病状态有活性的第二种治疗药物组合使用时,各化合物的剂量可与化合物单独使用时的剂量不同。本领域技术人员将容易地认识到适当剂量。
在另一个方面,本发明提供饮食组合物例如饮料,例如果汁、运动饮料、酸乳酪饮料、乳饮料、茶等或固体食品例如速食条(food snackbar),例如水果条、果仁条和谷类食品条、谷类食物、甜点、巧克力(例如牛奶和深色巧克力)条等,该组合物含苹果提取物和/或多酚分离物和/或上述组合。
在一个实施方案中,饮食组合物还可含其它营养物例如维生素、矿物质和益生元,例如低聚果糖和苹果纤维和益生菌。
在一个实施方案中,将饮食组合物配制为前文定义的液体剂型。在另一个实施方案中,液体剂型还可含增稠剂、张力调节剂和缓冲剂。
合适的张力调节剂的实例包括糖和氯化钠,例如可用它们提供特定浓度的溶液和等渗溶液。合适的缓冲剂的实例包括柠檬酸盐和磷酸盐。
因此,在另一方面,提供前文所述的饮食组合物,用于预防或治疗心血管疾病和/或结肠癌。
在另一方面,提供前文定义的饮食组合物,该组合物包括在用于预防或治疗心血管疾病和/或结肠癌的药物制备中。
在本发明的再另一方面,提供治疗或预防心血管疾病和/或结肠癌的方法,该方法包括给予前文定义的饮食组合物。
在本发明的再另一方面,提供药用组合物,该组合物含前文定义用于预防或治疗心血管疾病和/或结肠癌的饮食组合物。
现在,通过以下非限制性实施例举例说明本发明。
实施例1:具有高多酚含量的苹果的制备
按前文所述,使得自山楂(Crataegus oxyacantha)的水果与酸苹果(苹果属)杂交。剖面测量得到的水果中的多酚含量,结果见表1所示,其中将得到的多酚含量与市售苹果对比:
表1-本发明苹果的多酚含量与市售苹果的比较
苹果 | 代码 | 总多酚含量(mg/kg)-干重 | 总多酚含量(mg/kg)-鲜重 |
传统甜点级 | 4321 | 20,525 | 4,527 |
传统甜点级 | 4221 | 16,755 | 3,327 |
传统甜点级 | 0223 | 16,255 | 2,928 |
传统甜点级 | 4251 | 14,388 | 3,067 |
传统甜点级 | 4921 | 13,759 | 2,773 |
传统甜点级 | 5271 | 12,666 | 2,458 |
传统甜点级 | 4241 | 11,454 | 2,339 |
现代甜点级(红) | 4261 | 9,951 | 2,232 |
现代甜点级(绿) | 5281 | 3,506 | 730 |
苹果A | 4211 | 189,585 | 33,375 |
苹果B | 4201 | 186,817 | 34,701 |
苹果C | 3331 | 64,955 | 14,750 |
苹果D | 3102 | 50,317 | 10,161 |
苹果E | 4361 | 48,751 | 10,290 |
苹果F | 4231 | 48,733 | 9,920 |
苹果G | 3301 | 46,961 | 10,348 |
苹果H | 4392 | 46,500 | 11,249 |
苹果I | 4351 | 32,739 | 6,883 |
以3份样品的平均值作为样品结果(n=420),各样品由7个独立的水果组成,该7个独立的水果从单独树的外部(北、东、南和西位置)和树的顶端、底部和中部采摘。
应注意,表1是指总多酚含量,但仅测量了黄烷-3-醇单体和包括(-)-表儿茶素、(+)-儿茶素、二聚体、三聚物、四聚体、五聚物、六聚物、七聚物和多聚物的聚合物。因此,总多酚含量很可能比表1中提供的量大得多。
由表1所示结果可以看到,本发明苹果A-I具有比市售苹果大的多酚含量。
实施例2:用表儿茶素提取物进行心血管研究
招募10名健康志愿者,以改善血管紧张从而改善心血管功能的方式,测试由本发明方法得到的表儿茶素提取物的有效性。给予5名志愿者安慰剂水果饮料,给5名志愿者提供相同试验饮料,但加入1mg/kg体重(基于(-)-表儿茶素单位)。通过反射率连续量化血管紧张,通过非侵入型数字光电容积脉搏波描记法(photoplethysmography)和连续的研究人员独立性的自动分析数字体积脉冲(volume pulse)的运算法得到反射率。数据以相对僵硬指数SI(m/s)提供,并与血管年龄相关。通过红光和红外线穿过指腹(finger pulp)的透射率测量脉波。确定一阶导数的局部最小值,从而定义脉波的相应转折点(=拐点)。由转折点(=拐点)后的第3-第7数据点的平均值计算反射率。
图1和图2显示2.5小时试验结果。这些图表明,与对照相比,消耗含提取物的试验饮料的组(n=10)的动脉僵硬指数(SI;图1)和血管年龄(图2)统计学上有改善(即降低)。
Claims (1)
1.得到苹果的方法,其中所述苹果的总多酚含量大于10000mg/kg鲜重,所述方法包括使山楂(Crataegus oxyacantha)与苹果属的酸苹果(crabapple)杂交的步骤,其中所述山楂和酸苹果是蔷薇科的成员。
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PCT/GB2007/003025 WO2008017845A1 (en) | 2006-08-09 | 2007-08-08 | Apples with high polyphenolic content |
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CN1121924A (zh) * | 1993-12-06 | 1996-05-08 | 日加威士己株式会社 | 水果多酚及其生产方法以及其用途 |
WO1998041096A1 (en) * | 1997-03-19 | 1998-09-24 | Jang Arthur H K D | Herbal extract composition and method of making the same |
DE19823679A1 (de) * | 1998-05-20 | 1999-11-25 | Nativia Ltd | Verwendung von Crataegus-Zubereitungen zur Prophylaxe und Therapie neoplastischer Erkrankungen |
CN1474701A (zh) * | 2000-09-12 | 2004-02-11 | �ռ���ʿ����ʽ���� | 野苹果果实多酚及其制造方法 |
CN1646148A (zh) * | 2002-03-29 | 2005-07-27 | 城田安幸 | 抗癌剂或免疫激活剂等药剂及保健饮食品 |
CN1802101A (zh) * | 2003-06-16 | 2006-07-12 | 曼海姆/奥克森富特希德楚格股份公司 | 异麦芽酮糖醇(1,6gps和1,1gpm混合物)作为生产用于治疗肠道疾病的药物及其他用途的益生元的应用 |
WO2007026101A1 (fr) * | 2005-08-31 | 2007-03-08 | Societe Cooperative Agricole D'elle Et Vire | Procede d'obtention d'un extrait vegetal de fruits a pepins, extrait vegetal ainsi obtenu et ses utilisations |
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JP5290174B2 (ja) | 2013-09-18 |
AU2007283264A1 (en) | 2008-02-14 |
CA2660247A1 (en) | 2008-02-14 |
KR20090051209A (ko) | 2009-05-21 |
US20130281527A1 (en) | 2013-10-24 |
NZ575369A (en) | 2012-06-29 |
US20110135770A1 (en) | 2011-06-09 |
WO2008017845A1 (en) | 2008-02-14 |
JP2010500016A (ja) | 2010-01-07 |
AU2007283267B2 (en) | 2013-08-01 |
CN101553137A (zh) | 2009-10-07 |
KR20090051208A (ko) | 2009-05-21 |
CN101610688A (zh) | 2009-12-23 |
US20140107053A1 (en) | 2014-04-17 |
AU2007283267A1 (en) | 2008-02-14 |
US8470380B2 (en) | 2013-06-25 |
NZ575370A (en) | 2011-11-25 |
AU2007283264B2 (en) | 2013-09-19 |
EP2059136A1 (en) | 2009-05-20 |
GB0615781D0 (en) | 2006-09-20 |
WO2008017842A1 (en) | 2008-02-14 |
US20100331399A1 (en) | 2010-12-30 |
EP2059138A1 (en) | 2009-05-20 |
CA2660251A1 (en) | 2008-02-14 |
JP2010500333A (ja) | 2010-01-07 |
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