CN1731938B - 益生元组合物 - Google Patents
益生元组合物 Download PDFInfo
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- CN1731938B CN1731938B CN2003801055586A CN200380105558A CN1731938B CN 1731938 B CN1731938 B CN 1731938B CN 2003801055586 A CN2003801055586 A CN 2003801055586A CN 200380105558 A CN200380105558 A CN 200380105558A CN 1731938 B CN1731938 B CN 1731938B
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Abstract
本发明涉及含有低聚糖的营养组合物，用于控制炎症性肠病及其相关的病症如腹泻和便秘。
Description
本发明涉及含有可溶性纤维、尤其是果糖低聚糖(FOS)和半乳糖低聚糖(GOS)的益生元(prebiotic)组合物，及其在治疗或预防胃肠道障碍如炎症性肠病(IBD)、腹泻和便秘中的用途。
益生元是对健康具有有益效果的不易消化的食品成分。对于被列为益生元的食品成分，其必须符合以下标准：i)在上胃肠道中既不水解，也不吸收，ii)通过受到刺激生长和/或成为代谢活性的和结肠共生的一种或有限数量的潜在有益细菌如乳杆菌属(lactobacilli)和双歧杆菌属(bifidobacteria)选择性发酵，iii)通过增加例如糖分解种类的数量而减少腐败微生物，能够改变结肠微生物区系朝向更健康的组成。双歧杆菌属是专性厌氧菌，其代谢碳水化合物，主要代谢为醋酸和乳酸，其进一步被全身代谢。据信它们在消化道的内环境平衡、抑制腐败和致病菌、一些维生素的产生、激活肠功能、帮助消化和吸收以及刺激免疫应响应中起重要作用。因为双歧杆菌属对氧和热敏感，故它们在食品中的应用受到限制。因此，对于显示有效性、耐受正常食品加工并选择性靶定固有有益细菌的益生元的关注增加。
对益生元期望的一种特性是持续朝向结肠末端的能力。消化道的该区段是数种慢性病状、包括结肠癌和溃疡性结肠炎的起源点。据信消化道该区段的微生物区系对这种障碍的发作或维持可起重要作用。膳食碳水化合物是近端结肠中主要的可发酵底物，并且随着其在细菌发酵过程中被降解，蛋白质成为更远端区段的主要可发酵底物。细菌蛋白质代谢产物包括毒性的和潜在致癌的化合物如胺、氨和酚类化合物。
由于膳食中缺少纤维素导致通过时间增加并且粪便量减少，便秘是住院患者的常见问题。疾病、药物、不活动和流体摄入减少也是引起该问题的原因。研究已显示：通过医院膳食和/或通过使用口服补充剂或肠营养物给患者补充更高纤维膳食，增加了粪便重量和排便频率。
炎症性肠病(IBD)是一组导致小肠和大肠炎症或溃疡的障碍。IBD最常见被列为溃疡性结肠炎或局限性回肠炎。IBD易发展为结肠癌。IBD的病因学未知，并且通过目前的药物治疗不能治愈。其涉及许多因素，尤其是遗传、环境、免疫和微生物。
溃疡性结肠炎是通常发生在直肠和结肠下半部或可能作用于整个结肠的炎症反应。症状包括出血、出血性腹泻、直肠出血痛、发烧、体重减轻，还可以引起并发症如结肠穿孔、结膜炎、脓肿、口腔溃疡、皮肤病变。数项研究牵涉溃疡性结肠炎中的硫酸盐还原细菌如脱硫弧菌属(Desulfovibrio)。将硫酸盐还原成硫化物的这些细菌存在于50％的健康人群中，但普遍存在于患有溃疡性结肠炎的人群中(97至100％)；它们可增加IBD患者的硫化物生成，并引起损害如削弱丁酸盐氧化、损害上皮细胞屏障、引起细菌和食品抗原易位以及炎症。其它细菌可牵涉于溃疡性结肠炎，如大肠杆菌(E.coli)、螺杆菌(Helicobacter spp.)，尽管它们的作用似乎不太肯定。溃疡性结肠炎通过目前的药物治疗不能治愈，但是通过使用抗炎药可以控制。可以用于治疗患轻微或中度疾病患者的药物如柳氮磺胺吡啶可能引起副作用，如恶心、呕吐、腹泻或头痛。皮质类甾醇可以用于更严重患病的患者，但特别可能增加感染的风险。在一些情况中，需要外科手术来去除患病的结肠。
局限性回肠炎不同于溃疡性结肠炎，因为其导致肠壁内更深处的炎症并可能发生在胃肠道的任何部分，且小肠是最常见的位置。其还是一种慢性病症并可能发生在一生的各个时间。
肠易激惹综合征(IBS)以持续周期性腹痛结合无规律的排便习惯如腹泻、便秘或两者兼具为特征。通过目前的药物治疗不能治愈IBS。
近几年，部分消费者对除了具有营养价值以外还对健康具有正向作用的食品的需要增加。尤其是，对于开发含有延长发酵时间能到达末端肠并在那增加双歧杆菌属数量的益生元的功能食品的关注增加。
人体内研究已显示：向膳食中添加果糖低聚糖(FOS)导致粪便中的双歧杆菌属增加，其是有效的益生元。然而，高含量FOS可能导致人志愿者产生过多的气体，在生产益生元食品时应使用最低有效量的FOS。故需要开发新益生元组合物。
本发明人已惊人地发现：半乳糖低聚糖(GOS)存在下，FOS的益生元特性显著提高，并且已经观察到，在促进有益菌如双歧杆菌属和乳杆菌属生长方面，FOS和GOS的效应大于加合效应，即协同效应。
由于该协同效应，有可能以较低剂量FOS获得等同或提高的益生元效果。这具有以下优势：可以在体内获得强效力的益生元效果，同时避免以可能导致副作用的含量摄入任何单一益生元的需要。此外，可获得的最大益生元益处优于单个益生元所获得的益处。
因此，本发明一方面提供了含有FOS和GOS的组合物，此后称为本发明组合物。
本发明另一方面提供了用作药物或临床产品的根据本发明的组合物。
本发明另一方面提供了本发明组合物在制备用于治疗或预防胃肠道(gastrointestinal transit，GI)障碍如IBD、腹泻或便秘的药物如临床产品或营养组合物中的用途。
本发明另一方面提供了本发明组合物在制备用于预防或治疗慢性消化道障碍如IBD和/或用于延长与该障碍相关的缓解期或改善与该障碍相关的症状或病症如溃疡性结肠炎、局限性回肠炎和/或结肠癌的药物或营养组合物中的用途。
本发明再一方面提供了根据本发明的组合物在制备药物如临床产品或营养组合物中的用途，所述药物或营养组合物用于改变消化道细菌种群朝向更健康组成，例如用于刺激有益消化道细菌如双歧杆菌属和/或乳杆菌属的生长和/或代谢和/或抑制非有益肠道菌如拟杆菌属(Bacteroides)、大肠杆菌属(coliforms)、梭菌属(Clostridium)、硫酸盐还原细菌的生长和/或代谢。
本发明进一步提供本发明的组合物在制备用于预防或治疗致病消化道细菌感染的药物如临床产品或营养组合物中的用途。
本发明另一实施方案中，提供了根据本发明的组合物在制备用于预防或治疗IBS或其综合征的药物或营养组合物中的用途。
膳食纤维尤其是果聚糖和/或不易消化低聚糖的摄入可提高胃肠道内乳酸产生菌的密度并减少不期望微生物如肠杆菌科(Enterobacteriaceae)的数量。后者包括数种病原体。因此，摄入膳食纤维如果聚糖和/或低聚果糖可以用于选择性地刺激胃肠道内有益菌的生长。而有益菌/致病菌的比例提高又导致对宿主的有益健康效果。
在此所用的术语“可溶性纤维”指的是能够在结肠经受发酵产生短链脂肪酸(SCFA)的纤维。
在此所用的术语“低聚糖”指的是由至少两个至高达20个糖苷连接的单糖单元组成的糖，即聚合度(DP)为2至20、优选2至15个单糖单元、更优选2至10个单糖单元、甚至更优选2至7个单糖单元或2至6个单糖单元。
果糖低聚糖(也称为低聚果糖)(FOS)是不易消化的低聚糖，是果聚糖菊糖小类的成员。它们天然存在于多种植物中，包括洋葱、大蒜、青葱、小麦、黑麦、香蕉、芦笋、西红柿、朝鲜蓟、大丽花和菊苣根。通过酶促、通过化学技术或通过从天然物质中提取可以生产FOS。短链FOS由一至三个果糖分子连接一分子蔗糖组成：它们的聚合度(DP)不高于6，可以通过使用果糖转移酶(fructosylating enzyme)从蔗糖合成。用这些果糖转移酶处理蔗糖，得到含有2、3或4个果糖单元的FOS混合物，如1-蔗果三糖、蔗果四糖(nystose)和果糖-蔗果四糖。人体内研究已显示：添加到膳食中的FOS导致粪便中双歧杆菌增加，是非常有效的益生元。
在此所用的术语“FOS”包括FOS和短链FOS。根据本发明，FOS可以含有2至20个糖单元、优选2至15个糖单元、更优选为2至7个糖单元、甚至更优选为2至6个糖单元。本发明的一个实施方案中，FOS可以含有基于FOS的总重约95％重量的二糖至七糖。
果糖低聚糖可商购，例如来自Beghin-Meiji Industries(法国)的Actilight
其含有约92％重量的FOS，或各种级别的来自Orafti(Tienen，比利时)的低聚果糖(Raftilose)如RAFTILoSE&commatP95，其含有约95％重量的FOS，其由聚合度为2至约7的链组成，通常DP为3.5至4.5，并含有总重约5％重量的葡萄糖、果糖和蔗糖。
半乳糖低聚糖(GOS)可以包括主要由作为糖成分的半乳糖组成的二、三、四、五和六糖，并通过β-半乳糖苷酶作用于乳糖形成。根据本发明，GOS可以含有2至15个糖单元、优选2至10个糖单元、更优选2至7个糖单元、甚至更优选2至6个糖单元。本发明的一个实施方案中，基于GOS的总重，GOS可以含有约0至约45％重量的二糖、优选约10％至约40％重量的二糖、更优选约20％至约35％重量的二糖、甚至更优选约33％重量的二糖。根据本发明，基于GOS的总重，GOS可以含有约0至约50％重量的三糖、优选约10％至约45％重量的三糖、更优选约20％至约40％重量的三糖、甚至更优选约39％重量的三糖。根据本发明，基于GOS的总重，GOS可以含有约0至约50％重量的四糖、优选约5％至约45％重量的四糖、更优选约10％至约40％重量的四糖、甚至更优选约18％重量的四糖。根据本发明，基于GOS的总重，GOS可以含有约0至约30％重量的五糖、优选约1％至约25％重量的五糖、更优选约2％至约10％重量的五糖、甚至更优选约7％重量的五糖。
在此所用的术语“GOS”包括上述定义的GOS，和反式半乳糖低聚糖，也称为tGOS。
GOS可商购，例如来自Borculo Domo Ingredients(荷兰)的
其含有约58％重量的半乳糖低聚糖、23％重量的乳糖和19％重量的葡萄糖；如来自Borculo Domo Ingredients(荷兰)的
GOS 10(粉末)，其含有约28％重量的半乳糖低聚糖、46.5％重量的单糖和二糖、17.5％重量的蛋白质、3.1％重量的矿物质、1％重量的脂肪和4％重量的水分，且其可作为与50％乳清蛋白浓缩物(WPC 35)共同喷雾干燥的混合物获得；或来自Borculo Domo Ingredients的Vivinal GOS(糖浆)，其含有75％重量的干物质，其中41％重量为单糖和二糖，59％重量为GOS。
本发明组合物中所含的FOS和GOS的量可以根据各种相关因素来确定，包括给药目的、个体患者的年龄、性别和体重、本发明组合物的形式、例如粉末或即可食用的组合物如即可饮用的组合物或速溶饮料，以及症状的严重程度。
本发明组合物可以含有FOS的量为至少0.3g至约20g、优选约0.5至约12g、更优选约0.5至约5g。
根据本发明，本发明组合物中可以含有的GOS的量为约0.3g至约20g、优选约0.5至约12g、更优选约0.5至约5g。
FOS可适宜地以以下的量存在于例如固体形式、如粉末形式的本发明组合物中：基于组合物总重约0.1至约40％重量、优选约0.2至约30％重量、例如约0.5至约20％重量、优选约1至约15％重量、更优选约2至约12％重量。
例如固体形式、如粉末形式的本发明组合物中含有的GOS的量基于组合物的总重、例如基于粉末组合物的总重可为约0.1至约40％重量、优选约0.2至约30％重量、优选约0.5至约20％重量、更优选约1至约15％重量、甚至更优选约2至约12％重量。
根据本发明，例如固体形式、如粉末形式的本发明组合物中含有的FOS和GOS混合物的量基于组合物的总重、例如基于粉末组合物的总重可为约0.1至约60％重量、优选约0.2至约40％重量、优选约0.5至约30％重量、优选约1至约25％重量、优选约2至约20％重量、甚至更优选约2％至约15％重量。
本发明的另一实施方案中，根据本发明的即可食用组合物中含有的FOS的合适量基于即可食用组合物的总重可高达约20％重量，或高达约15％重量、例如约0.05至约20％重量、例如约0.1至约10％重量、例如约0.2％至约5％重量，或约0.5至约3％重量。
根据本发明的即可食用组合物中GOS的量基于即可食用组合物的总重可以高达约20％重量或高达约15％重量，例如约0.05至约20％重量、例如约0.1至约10％重量、例如约0.2％至约5％重量、例如约0.5至约3％重量。
根据本发明，本发明即可食用组合物中FOS和GOS混合物的量基于组合物例如基于即可食用组合物的总重可高达约40％重量、高达约30％重量、例如约0.05至约40％重量、约0.1至约30％重量、约0.2至约20％重量、约0.5至约15％重量、约1至约10％重量、约2％至约5％重量、例如约25％、例如约20％、例如约10％重量、例如约5％重量。
FOS剂量例如每份的剂量如日剂量可以为例如约0.01g至约0.5g/kg体重、优选约0.03g至约0.3g/kg体重、更优选约0.05g至约0.2g/kg体重、甚至更优选约0.06g至约0.15g/kg体重。根据本发明，GOS剂量例如每份的剂量如日剂量可以为约0.01g至约0.5g/kg体重、优选约0.03g至约0.3g/kg体重、更优选约0.05g至约0.2g/kg体重、甚至更优选约0.06g至约0.15g/kg体重。FOS和GOS混合物的合适剂量例如每份的剂量如日剂量可以为例如约0.01g至约1g/kg体重、优选约0.03g至约0.6g/kg体重、更优选约0.05g至约0.4g/kg体重、甚至更优选约0.10g至约0.3g/kg体重。
可以含有的FOS和GOS混合物的合适剂量如日剂量为约1至约20g、优选约1至约15g、更优选约2至约10g，例如可以为约20g、优选约15g、更优选约10g、甚至更优选约5g。
一方面，本发明提供了本发明的组合物，其中FOS/GOS的重量比为约0.01至约50、优选约0.5至约20、优选约0.1至约10、更优选约0.2至约5、甚至更优选约0.3至约3、最优选约0.5至约2、甚至最优选约0.6至约1.5。FOS/GOS的重量比可以为约1。
当然，本发明组合物中活性成分的相对比例可以根据所涉及组合物的特定类型、例如是否是液体或固体形式或是否以营养物形式提供而酌情改变。因此，在此所述的所有所示的比例和相对重量范围均应理解为优选的表示或仅仅是单个发明的教导而非限制本发明的最宽范围。
根据本发明，本发明组合物可以进一步含有不溶性和/或可溶性纤维，如非淀粉多糖，例如纤维素、半纤维素、抗性淀粉、胶、瓜尔胶、水解瓜尔胶如部分水解瓜尔胶如以
获得(来自Novartis NutritionCorporation)、果胶、阿拉伯胶及其混合物。
本发明的组合物还可以含有多不饱和脂肪酸、尤其是顺式多不饱和脂肪酸，如n-3脂肪酸和/或n-6脂肪酸，例如α-亚麻酸(18:3)、十八碳四烯酸、二十碳五烯酸(EPA)(20:5)、二十二碳五烯酸(22:5)和二十二碳六烯酸(DHA)(22:6)、亚油酸(18:2)、γ-亚麻酸(18:3)、花生四烯酸(20:4)，呈游离形式或油或脂肪的形式，及其混合物。优选使用二十碳五烯酸和二十二碳六烯酸的组合。
本发明组合物还可以含有氮源如蛋白质和/或氨基酸，和/或脂肪来源如脂质，和/或碳水化合物来源。本发明组合物还可以包括维生素和/或矿物质。
本发明另一实施方案中，本发明组合物还可以含有其他低聚糖，例如乳果糖(lactulose)、木糖低聚糖(XOS)、大豆-低聚糖(SOS)、异麦芽糖低聚糖(IMO)、阿拉伯半乳聚糖(ABG)、龙胆低聚糖、果聚糖、部分水解的瓜尔胶(PHGG)及其混合物，优选XOS。
本发明进一步的实施方案中，本发明组合物基本上或全部由在此所述的FOS和GOS组成。
本发明的一个实施方案中，提供了营养或药物组合物，含有由上述的FOS和GOS组成的低聚糖混合物，例如由含有2至7个单糖单元的FOS和含有2至7个单糖单元的GOS组成的混合物。
根据本发明组合物的其他组分可包括已知具有健康益处的任何生物活性化合物或提取物，尤其是对胃肠道具有有益影响的化合物，如谷氨酰胺/谷氨酸盐(酯)或其前体。
本发明的组合物还可以含有一种或多种抑制细菌粘着在胃肠道上皮壁上的另外的物质，包括甘露聚糖、半乳糖醛酸低聚物，优选是天然来源的。本发明组合物可以与可用于治疗溃疡性结肠炎的药物组合，如美沙拉秦、柳氮磺胺吡啶、5-ASA剂、皮质类甾醇如肾上腺类固醇、强的松、氢化可的松或布地缩松；或与用于对抗疼痛、腹泻和感染或IBS的药物组合，如5-羟色胺-4受体激动剂，例如Zelnorm/ZelmacTM。例如，本发明组合物可以以组合药物制剂或药包的形式提供，用于与上述这些药物分别、相继或同时给药。这些药物可以和本发明组合物一起方便地配制成标准药物剂型。
本发明的一个实施方案中，本发明组合物不含有石南(Ericaceae)科的植物种，或源自小麦叶的材料。
本发明另一个实施方案中，本发明组合物不含有棉子糖。
本发明的一方面，根据本发明的组合物可以容易地掺入药物或营养制剂中，通常为类药物营养品(nutraceutical)、膳食补充剂、药物或功能食品和饮料产品。
在本发明的另一方面，本发明组合物可以用作药物。因此本发明组合物可以以药物形式或作为膳食补充剂服用，优选与至少一种药学上或营养学上可接受的载体组合。
膳食形式如补充剂或药物制剂形式的本发明组合物可以全部由本发明组合物组成，且任选含有药学上或营养学上可接受的载体。
在本发明的再一方面，提供了含有本发明组合物的药物如临床产品、营养或药物制剂如膳食补充剂。本发明的药物如临床产品、营养或药物组合物可以任选含有药学上可接受的载体。此外，根据本发明提供了用于同时、分别或相继使用的组合的药物制剂，以治疗或预防GI障碍，例如用于维持和/或恢复消化道微生物区系、用于刺激有益消化道细菌的生长或繁殖和/或抑制非有益或致病消化道细菌的生长或繁殖；用于治疗或预防IBD；用于延长与该障碍相关的缓解期或改善与该障碍相关的症状或病症，如溃疡性结肠炎、局限性回肠炎和/或结肠癌；用于抑制或延长IBD患者尤其是结肠炎(colitic)患者的缓解期。本发明的另一个实施方案中，本发明组合物如组合药物制剂可以用于预防或治疗IBS或其综合征。
在此所用的术语“有益消化道细菌”指的是有益的或潜在有益的消化道细菌，如乳杆菌属和双歧杆菌属；术语“非有益消化道细菌”指的是非有益的或致病的消化道细菌，如拟杆菌属、梭菌属、大肠杆菌属、硫酸盐还原细菌。
根据本发明，术语“营养组合物”指的是营养制剂和营养产品，如类药物营养品、营养或膳食补充剂、功能食品、饮料产品、膳食替代品或食品添加剂。
这类营养组合物可以是营养完全的，即可以包括维生素、矿物质、痕量元素以及氮、碳水化合物和脂肪酸来源，从而可以用作唯一的营养来源，提供基本上所有日常必需量的维生素、矿物质、碳水化合物、脂肪酸、蛋白质等。因此，可以以例如适于口服或管饲的营养平衡组合物形式如完全配方膳食或完全膳食来提供本发明组合物。
作为替代选择，可以作为膳食的一部分，即营养或膳食补充剂如以健康饮料的形式来提供本发明组合物。
提供低热量组合物如膳食替代品形式的本发明组合物可能是合乎需要的。在这种情况下，营养组合物如膳食替代品优选是低脂肪的，即基于组合物的总含热量小于约10en％，或基本上是无脂肪的，即少于约2.5en％为脂肪，如约2en％脂肪。适合的是，单份低热量营养组合物如膳食替代品的热值为低于约1000kcal、优选约200kcal至约500kcal。
适合的低热量营养组合物可以包括软饮料，如果汁、smoothie或基于大豆的饮料，或被分散于任何种类的食品中，如乳棒(dairy bar)、汤、谷类食品如早餐谷类食品、穆兹利
糖果、tab、曲奇、饼干、薄脆饼干如米脆饼，以及乳制品如冰冻牛奶、酸奶饮料、酸奶和水果饮料。
作为替代选择，本发明组合物可以作为高热量组合物如高热量膳食补充剂或膳食替代品提供，如热值高于约400kcal、优选高于约600kcal、更优选高于约800kcal。
根据本发明，本发明组合物如高热量组合物可以富含蛋白质，如基于组合物的总含热量可以含有高于约1en％的蛋白质(即1g每100kcal)、优选高于约2en％的蛋白质、更优选高于约4en％的蛋白质，例如可以含有约1en％至约15en％的蛋白质、优选约2en％至约10en％的蛋白质、更优选约3en％至约5en％的蛋白质。
本发明组合物如高热量组合物可以含有脂肪，例如基于组合物的总含热量高于约4en％、优选高于5en％、更优选高于6en％、甚至更优选高于7en％且最优选高于8en％。
本发明的一个实施方案中，提供的组合物例如每100ml含有约1至约3g FOS、约1至约3g GOS、约2至20g蛋白质、约1至约30g碳水化合物、约0.5至约20g脂肪以及矿物质和维生素，更优选约1.25g FOS、约1.25g GOS、约9g蛋白质、约22g碳水化合物和约9g脂肪以及矿物质和维生素。这类组合物可以是完全配方膳食。这类组合物如完全配方膳食可以是即可食用的组合物。
本发明组合物任选含有常规食品添加剂，如任何乳化剂、稳定剂、甜味剂、调味剂、着色剂、防腐剂、螯合剂、渗透剂、缓冲剂或pH调节剂、酸化剂、增稠剂、组织形成剂(texturiser)等。
根据本发明的合适的产品形式包括溶液、即可食用的组合物如即可饮用的组合物、速溶饮料、液体食物如软饮料、果汁、运动饮料、乳饮料、冰冻牛奶、酸奶饮料或汤。本发明另一个实施方案中，可以以浓缩物、粉末或颗粒如泡腾颗粒的形式来制造和出售本发明组合物，将其用水或其他液体如奶或果汁稀释，以得到即可食用的组合物、例如即可饮用的组合物或速溶饮料。
本发明的另一方面提供了本发明组合物作为食品添加剂的用途。
本发明的药物组合物如临床产品和营养组合物如膳食补充剂可以以常规剂型、以软凝胶、小药囊、粉末、糖浆、液体悬浮液、乳剂和溶液的形式提供。软胶囊中，优选将活性成分溶解或悬浮于合适的液体中，如脂肪油、石蜡油或液体聚乙二醇。可以任选加入稳定剂。
口服药物或膳食补充剂形式可以通过制药领域公知的常规配制方法制得，即通过将活性物质和可食用的药学上可接受的固体或液体载体和/或赋形剂一起混合，例如填充剂如纤维素、乳糖、蔗糖、甘露醇、山梨糖醇和磷酸钙，和粘合剂如淀粉、明胶、黄蓍胶、甲基纤维素和/或聚乙烯吡咯烷酮(PVP)。任选的添加剂包括润滑剂和流动调节剂，如硅酸、二氧化硅、滑石、硬脂酸、硬脂酸镁/钙、聚乙二醇(PEG)稀释液；崩解剂如淀粉、羧甲基淀粉、交联PVP、琼脂、褐藻酸和藻酸盐；着色剂、调味剂和熔化剂。可以将染料或色素加入片剂或糖衣丸包衣中，例如为了辨别的目的或指示活性成分的不同剂量。
本发明组合物可以是任何适于人给药的形式，尤其是给药于胃肠道的任何部位。本发明组合物的肠给药、优选口服给药和通过管或导管给药都涵盖于本发明中。
待施用的本发明组合物的给药量和给药方案根据各种相关因素来决定，包括给药目的、个体患者的年龄、性别和体重和患者症状的严重程度。
本发明的组合物可以在专科医生的指导下服用或自我服用。
本发明组合物、例如药物或营养组合物、例如掺入本发明组合物的食品或饮料任何人都可安全食用，尤其推荐用于遭受腹泻和/或便秘或与IBD相关的疾病、病症和症状、尤其是溃疡性结肠炎、局限性回肠炎或结肠癌或IBS或其综合征的哺乳动物如人、例如成人。本发明组合物、例如营养补充剂尤其推荐用于处于腹泻、便秘或上述其他慢性消化道障碍危险中的哺乳动物如人、例如成人，例如营养不良人群、住院和长期护理患者和/或缓解中的溃疡性结肠炎患者。本发明组合物尤其适于营养不良和/或老龄人群。
本发明的一个实施方案中，本发明涉及在需要这种治疗的包括人在内的哺乳动物中治疗和/或预防GI障碍的方法，所述GI障碍如上述与慢性消化道障碍相关的疾病、病症和症状，例如IBD、尤其是溃疡性结肠炎、局限性回肠炎、结肠癌或IBS或其综合征，该方法包括将有效量的根据本发明的组合物给药于所述哺乳动物。在此所用的术语“有效量”指的是能有效获得所期望治疗效果的量，如治疗和/或预防上述腹泻、便秘或与IBD相关的疾病、病症和症状、尤其是溃疡性结肠炎、局限性回肠炎、结肠癌，或与IBS相关的病症和症状。
本发明的另一个实施方案中，根据本发明的组合物可以用于制备药物或营养制剂，该药物或营养制剂用于预防或治疗与慢性消化道障碍相关的疾病、病症和症状、例如IBD、尤其是溃疡性结肠炎、局限性回肠炎、结肠癌，或用于在包括人在内的哺乳动物中预防或治疗上述IBS或其综合征，或用于治疗或预防胃肠道(GI)障碍如腹泻或便秘。
进一方面，本发明提供了维持和/或恢复肠微生物区系如消化道微生物区系的方法，用于改变消化道细菌种群朝向更健康组成、尤其是用于刺激有益消化道细菌如双歧杆菌属和/或乳杆菌属的生长和/或代谢和/或抑制非有益或致病消化道细菌如拟杆菌属、梭菌属、大肠杆菌属和/或硫酸盐还原细菌的生长和/或代谢。
仍然是本发明的另一方面，提供了预防或治疗致病消化道细菌感染的方法。
进一方面，本发明提供了预防和/或治疗与慢性消化道障碍相关的疾病、病症和症状、例如IBD、尤其是溃疡性结肠炎、局限性回肠炎、结肠癌的方法，或用于延长IBD患者尤其是溃疡性结肠炎患者缓解期的方法。
仍然是进一方面，本发明提供了治疗或预防胃肠道传递(GI)障碍如腹泻或便秘的方法。
本发明进一步提供了预防或治疗哺乳动物、包括人的上述IBS或其综合征的方法。
根据本发明组合物的应用形式，即作为完全配方膳食如完全膳食或作为膳食的一部分、食品添加剂、饮料、小药囊、片剂或胶囊，本发明组合物可以每日一次至每日五或六次服用。对于使用本发明组合物作为正常膳食补充剂的患者，日剂量可以为每天1或2份。对于接受本发明组合物作为其全部日营养摄入的患者，可建议每日高达六份。对于本发明组合物一天中的服用时间没有限制，例如和主食一起服用。
本发明的组合物可以在专科医生指导下服用或自我服用。
最理想的是，在患者护理和治疗期间，至少一周一次或一天一次有规律地食用本发明组合物如膳食补充剂，例如直至记录到每周正常排便(例如3至10次)和正常粪便(例如固体)，和/或直至腹泻或便秘减轻或停止，和/或患者不再经受腹部不适、疼痛、肠气胀、胃气胀，和/或粪便中不再排泄血液或过多粘液。
另一个实施方案中，本发明涉及本发明组合物的制备方法，其中该方法包括密切混合本发明组合物的各组分。这种方法是本领域技术人员公知的。
可以在如上述适应症的标准临床试验中和标准动物模型中观察到所有本发明组合物的效用，例如，对于哺乳动物、例如成人使用约0.01至约1g/kg体重/天剂量的FOS和GOS、优选约0.05至约0.5g/kg体重/天，或使用约1至约30g或高达约30g每份剂量的FOS和GOS。本发明组合物用于维持和/或恢复肠微生物区系、例如用于预防和治疗IBD及其相关疾病或症状的效果可以通过本领域技术人员公知的任何方法来监控，例如分析结肠内容物、活体检查分析如乙状/直肠区段。可以比较健康个体和那些例如患有溃疡性结肠炎的个体的微生物种群，并可以通过如下方法检测结肠细菌种群的差异，例如荧光原位杂交(FISH)和/或变性凝胶梯度电泳(DGGE)、聚合酶链反应(PCR)和16S rDNA序列分析。FISH是使用标记有荧光染料的16SrDNA寡核苷酸探针的与培养无关的分子技术(参见表1)。FISH方法可以原位显象和定位环境样品中的全部细菌细胞。应该了解：该方法是本领域技术人员容易获知的。
表1使用FISH用于表征消化道微生物区系的寡核苷酸探针
一项人体临床试验如下进行：
在溃疡性结肠炎患者中进行随机双盲研究，比较标准营养补充剂和本发明组合物，例如使用约0.01至约1g/kg体重/天、优选约0.05至约0.5g/kg体重/天、更优选约0.1或0.15至约0.2g/kg体重/天剂量的FOS和约0.01至约1g/kg体重/天、优选约0.05至约0.5g/kg体重/天、更优选约0.1或0.15至约0.2g/kg体重/天剂量的GOS，目的在于评价12个月的治疗期内对肠功能、粪便微生物区系或结肠益生元发酵的效用。测试了30名患者。每周测定以下参数：排便频率、粪便存血、过多粘液产生、粪便稠度、胃气胀、肠气胀和腹痛。通过FISH来表征粪便的微生物区系，并将有益种类(如乳杆菌属和双歧杆菌属)数量和疾病状态相关属(如梭菌属、拟杆菌属和硫酸盐还原细菌)的数量相比较。还测定了粪便样品中短链脂肪酸(乙酸、丙酸、丁酸、乳酸和戊酸)的浓度。使用PCR和DGGE进行了总粪便DNA提取物的研究。
通过以下实施例将进一步说明本发明。
实施例1：数种低聚糖及其混合物的益生元潜能的体外研究
用作阳性对照的果糖低聚糖(FOS)是Actilight 
Beghin-MeijiIndustries，法国(含有92％低聚糖)。
半乳糖低聚糖(GOS)是
FCDF，荷兰(含有58％低聚糖、23％乳糖、19％葡萄糖)。
木糖低聚糖(XOS)是Xylo-oligo 
Suntory Limited，日本(含有91％低聚糖)。
大豆低聚糖(SOS)是大豆低聚糖糖浆，Soya Oligo Japan Inc.，日本(含有23％低聚糖、21％蔗糖、31％其他糖)。
阿拉伯半乳聚糖(ABG)是ClearTrac AG-
Larex Inc.，美国(含有95％可溶性纤维)。
阿拉伯胶(AG)也称为gummi arabicum，是ColloidesNaturels International，法国(含有85％可溶性纤维)。麦胚(WG)是Biogerm 
Multiforsa，瑞士(含有32％低聚糖、30％蛋白质、12％纤维、7％脂肪)。
异麦芽糖低聚糖(IMO)是Isomalto 
Showa Sangyo Co.，日本(含有89％低聚糖)。
1.方法
使用体外粪便分批培养来测定FOS、GOS、XOS、SOS、ABG、AG、WG和IMO的益生元潜能。类似地，体外考察了等比例低聚糖混合物即FOS+GOS、AG+FOS、FOS+XOS、XOS+GOS和AG+GOS的益生元潜能。FOS用作阳性对照，相对该阳性对照比较了供试碳水化合物的益生元性质。使用来自6名健康成人的粪便接种物进行粪便分批培养，使用一种或多种供试化合物作为唯一碳水化合物来源，这些健康成人没有已知的代谢和胃肠道疾病(例如糖尿病、溃疡性结肠炎、局限性回肠炎、胃溃疡、IBS、胃肠炎和癌症)。就地收集样品，保存于厌氧室中并在收集后最多5分钟内使用。用0.1M无氧磷酸盐缓冲液(pH7.4)制得1∶10稀释液，并在细菌分离器中将样品均化2分钟。
(a)分批培养
在37℃于搅拌的容器中，将135ml无菌恒化培养基保持于厌氧条件下(连续冲入无02的N2)。将培养物pH维持在6.7。然后加入1％重量/体积的碳水化合物来源。每个容器接种15ml无氧磷酸盐缓冲盐水制得的新鲜人粪便悬液(10％w/v)。分批培养维持24小时。
(b)细菌计数
在生长0、5、10和24小时时将分批培养的样品取样。采用荧光原位杂交(FISH)用于细菌学考察，使用群特异性荧光标记的靶向16S rRNA的DNA探针计数总细菌、拟杆菌属、双歧杆菌属、产气荚膜梭菌(lostridiumperfringens)/溶组织梭菌亚群和乳杆菌属(参见表1)。
2.结果
在此呈现和讨论的结果是每个不同潜在益生元的6轮综合结果。
在发酵10和24小时后，FOS+GOS均被双歧杆菌属选择性地高度发酵。在两个点的增加都高于FOS或GOS单独发酵。拟杆菌属的数量略微降低。该组合显示出头10小时发酵过程中所有测试底物的乳杆菌属的最大增加之一。增加在24小时后不再保持，但是数量停留在高于初始水平上。尽管梭菌属在10小时显示小量增加，但24小时后数量跌落低于初始水平。24小时后观察到拟杆菌属数量有非常小的降低。FOS+GOS被双歧杆菌属和乳杆菌属迅速利用，且增加的数量远远高于单独的FOS或GOS。发酵10小时后乳杆菌属相对大量的增加是非常重要的，因为益生元通常被双歧杆菌属发酵，引起乳杆菌属的变化即便有的话也非常小。看来该组合协同增加了有益菌的数量。
3.讨论
结果清楚地表明：与该试验中测试的可溶性纤维相比，低聚糖更具选择性地被有益菌、主要是双歧杆菌属和乳杆菌属发酵。
FOS和GOS的组合协同发挥作用，并且和单独测试这些低聚糖相比较，令人惊奇地将双歧杆菌属和乳杆菌属提高至较高的量。与两种低聚糖分别测试相比较，较少有益菌似乎不受组合影响朝向数量减少，而是略有增加。由于其选择性增强生长的特性，它们是特别好的益生元。FOS和GOS的组合清楚地显示了整个发酵过程中所有测试的成分和组合中的最佳益生元排序。
实施例2：营养组合物：100g
来自Novartis Nutrition Corporation
实施例3：营养组合物：每100g
该组合物是粉末形式，食用前应将日剂量(42g)溶解于约200ml冷水中。
(2)来自Borculo Domo Ingredients(荷兰)，含有约28％重量的GOS。
(3)来自Beghin-Meiji Industries(法国)，含有约92％重量的FOS。
实施例4：即可饮用的膳食补充剂，每100ml(100kcal)
(4)来自Vivinal GOS，来自Borculo Domo Ingredients(荷兰)。
(5)来自Raftilose P95，来自Orafti(比利时)。
Claims (15)
1.含有果糖低聚糖和半乳糖低聚糖的营养或药物组合物，其中所述果糖低聚糖含有高达约95％重量的由聚合度2至7的链组成的低聚果糖，所述半乳糖低聚糖含有高达约95％重量的由聚合度为2至7的链组成的低聚半乳糖，其中所述组合物中含有的果糖低聚糖和半乳糖低聚糖混合物的量基于组合物的总重为0.1％至60％，其中果糖低聚糖和半乳糖低聚糖的重量比为0.2至5。
2.根据权利要求1的组合物，其中含有的果糖低聚糖和半乳糖低聚糖混合物的量基于粉末组合物的总重为2.0至55％重量。
3.根据权利要求1的组合物，其是高热量组合物。
4.根据权利要求1的组合物，其含有基于组合物的总含热量高于约1en％的蛋白质。
5.根据权利要求1的组合物，其还包含谷氨酰胺。
6.根据权利要求1的组合物，其是完全配方膳食。
7.根据权利要求1的组合物，其每100ml含有：1至3g果糖低聚糖、1至3g半乳糖低聚糖、2至20g蛋白质、1至30g碳水化合物、0.5至20g脂肪以及矿物质和维生素。
8.根据权利要求7的组合物，其每100ml含有：约1.25g果糖低聚糖、约1.25g半乳糖低聚糖、约9g蛋白质、约22g碳水化合物和约9g脂肪。
9.根据在前任一权利要求的组合物，其是即可食用的组合物。
10.根据权利要求1-9任何一项的组合物在制备用于治疗或预防选自腹泻和便秘的胃肠道障碍的药物或营养组合物中的用途。
11.根据权利要求1-9任何一项的组合物在制备用于维持和/或恢复肠内微生物区系的药物或营养组合物中的用途。
12.根据权利要求1-9任何一项的组合物在制备用于预防或治疗炎症性肠病和/或预防结肠癌的药物或营养组合物中的用途。
13.根据权利要求12的用途，其中的炎症性肠病是溃疡性结肠炎和局限性回肠炎。
14.根据权利要求1-9任何一项的组合物在制备用于刺激双歧杆菌属和/或乳杆菌属生长和/或抑制拟杆菌属、梭菌属、大肠杆菌属、硫酸盐还原细菌中至少一种生长的药物或营养组合物中的用途。
15.根据权利要求1-9任何一项的组合物在制备用于预防或治疗致病消化道细菌感染的药物或营养组合物中的用途。
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102861108A (zh) * | 2012-09-07 | 2013-01-09 | 李宁 | 一种用于治疗便秘的药物组合物及其应用 |
| CN102861108B (zh) * | 2012-09-07 | 2013-12-25 | 李宁 | 一种用于治疗便秘的药物组合物及其应用 |
| CN107981359A (zh) * | 2017-12-12 | 2018-05-04 | 河北三元食品有限公司 | 益生元组合物及其应用 |
| CN108338984A (zh) * | 2018-02-26 | 2018-07-31 | 量子高科(中国)生物股份有限公司 | 具有清肠作用的组合物及其制备方法和在碳水化合物组件特医配方食品中的应用 |
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| ZA200504385B (en) | 2006-07-26 |
| RU2005121665A (ru) | 2006-04-27 |
| TW200505462A (en) | 2005-02-16 |
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| MXPA05006266A (es) | 2005-08-19 |
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| AU2003294835A1 (en) | 2004-06-30 |
| AU2003294835B2 (en) | 2007-05-03 |
| ES2449016T3 (es) | 2014-03-17 |
| WO2004052121A1 (en) | 2004-06-24 |
| US7794746B2 (en) | 2010-09-14 |
| BR0317272A (pt) | 2005-11-08 |
| RU2358474C2 (ru) | 2009-06-20 |
| JP2006509797A (ja) | 2006-03-23 |
| BRPI0317272B1 (pt) | 2016-03-22 |
| PL213665B1 (pl) | 2013-04-30 |
| TWI337080B (en) | 2011-02-11 |
| CA2508693A1 (en) | 2004-06-24 |
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