CN106102484B - 用于减少膳食脂肪吸收的包含秋葵的组合物 - Google Patents
用于减少膳食脂肪吸收的包含秋葵的组合物 Download PDFInfo
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- CN106102484B CN106102484B CN201580004721.2A CN201580004721A CN106102484B CN 106102484 B CN106102484 B CN 106102484B CN 201580004721 A CN201580004721 A CN 201580004721A CN 106102484 B CN106102484 B CN 106102484B
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Abstract
包含(任选地处理的)秋葵种植物的可食用部分的组合物,其通过结合受试者的胃中的膳食脂肪,用于减少受试者的膳食脂肪的吸收或用于治疗或预防肥胖和/或用于治疗或预防代谢性疾病,如代谢综合征,或用于管理受试者的体重。
Description
技术领域
本发明涉及包含秋葵种植物的可食用部分的组合物,其任选地与其他活性成分组合,用于减少膳食脂肪吸收。所述组合物特别地用于治疗或预防肥胖和/或用于治疗或预防代谢性疾病,如代谢综合征。
发明背景
由于肥胖在全球人口中日益盛行,体重管理已成为现代保健的关键要素,并且需要更有效的减重手段。
肥胖可以由超过身体能量消耗的能量摄入水平引起。体重的减少可以通过减少来自饮食的总热量摄入,或通过减少具体膳食组分贡献的热量摄入来实现。例如,可以通过控制膳食脂肪消耗或通过控制体内脂肪吸收来减少热量摄入。由于脂肪摄入在心血管疾病的发病机理中的作用,控制脂肪摄入是重要的。
改变生活方式难以实现,并且由于在发达国家中体力活动持续减少以及西式饮食被发展中国家采用,因此预期肥胖的盛行和其相关的健康问题在全世界范围内增加。然而,用于促进体重控制或体重减轻的目前可用的药物和补充剂的有效性是非常易变的,特别是如果它们未与限制热量的饮食和锻炼方案联合使用时。
奥利司他(Orlistat)作为抗肥胖药物已经被美国食品和药物管理局批准。奥利司他以赛尼可(Xenical)和阿莱(Alli)的名称销售,其抑制小肠中的胰脂肪酶的活性。胰脂肪酶将甘油三酸酯分解成脂肪酸和甘油单酯,其随后被吸收到体内。因此,抑制脂肪酶的活性有效地减少脂肪吸收。在服用该药物时,建议的是低脂饮食。在缺乏主要膳食改变的情况下,胃肠道不适、腹泻和胀气的不良反应限制了其使用(参见Heck等人,Orlistat,a newlipase inhibitor for the management of obesity,Pharmacotherapy,20,p270-279,2000)。在1999至2008年,服用该药剂的患者中也有严重的肝损伤的报告,包括肝功能衰竭的病例(美国食品和药物管理局新闻稿,2009年8月24日)。另一种药物,西布曲明(Sibutramine)是血清素和去甲肾上腺素再摄取抑制剂,并且通过抑制食欲减少体重。然而,欧洲药品管理局的审查发现,西布曲明对心血管的风险大于其益处。新出现的证据表明,使用该药物有非致命性心脏病发作和中风增加的风险。
由于现有药物的副作用,如以上讨论的那些,对开发控制体重和/或治疗肥胖以及相关障碍,如代谢综合征的新的组合物有持续的需求。
发明概述
根据第一个方面,提供了组合物,其包含秋葵种植物的可食用部分,用于减少受试者,例如人或动物受试者的膳食脂肪吸收。
根据第二个方面,提供了用于减少膳食脂肪吸收的组合物,所述组合物包含秋葵种植物的可食用部分、果聚糖和有机酸。
根据第三个方面,提供了包含秋葵种植物的可食用部分、果聚糖和有机酸的组合物,其用于治疗受试者的肥胖。
根据第四个方面,提供了包含秋葵种植物的可食用部分、果聚糖和有机酸的组合物,其用于治疗受试者的代谢性疾病。
根据第五个方面,提供了减少受试者的膳食脂肪吸收的方法,所述方法包括给予受试者有效量的包含秋葵种植物的可食用部分的组合物,以使膳食脂肪吸收减少,任选地其中所述组合物还包含果聚糖和有机酸。
根据第六个方面,提供了用于治疗或预防受试者的肥胖的方法,所述方法包括给予有效量的包含秋葵种植物的可食用部分的组合物,以治疗或预防肥胖,任选地其中所述组合物还包含果聚糖和有机酸。
根据第七个方面,提供了用于治疗或预防受试者的代谢性疾病的方法,所述方法包括给予有效量的包含秋葵种植物的可食用部分的组合物,以治疗或预防所述代谢性疾病,任选地其中所述组合物还包含果聚糖和有机酸。
根据第八个方面,提供了用于管理受试者的体重的非治疗性方法,所述方法包括给予受试者有效量的包含秋葵植物物种的可食用部分的组合物,以管理受试者的重量,任选地其中所述组合物还包含果聚糖和有机酸。
根据第九个方面,提供了包含秋葵种植物的可食用部分的组合物用于减少膳食受试者的脂肪吸收的用途。
根据第十个方面,提供了包含秋葵种植物的可食用部分的组合物用于控制、维持或减少受试者的体重的用途。
根据第十一个方面,提供了包含有效量的秋葵种植物的可食用部分的食品、或食品补充剂、或膳食补充剂、或代餐产品、或饮料、或饮料补充剂,任选地其中所述有效量足以根据本发明的第八个方面所述的方法管理受试者的重量。
根据第十二个方面,提供了包含有效量的秋葵种植物的可食用部分和一种或多种药学上可接受的载体的药物组合物,任选地其中所述有效量对于治疗或预防受试者的肥胖和/或代谢性疾病(例如,代谢综合征)是有效的,任选地其中所述药物组合物还包含果聚糖和有机酸。
附图简述
图1是比较根据本发明的一个实施方案的秋葵粉末与天然产物胭脂仙人掌和壳聚糖的脂肪结合能力的图。
图2是比较根据本发明的一个实施方案的包含秋葵、菊粉和柠檬酸的组合物与不包含所有三种组分的组合物的脂肪结合能力的图。
图3是比较根据本发明的一个实施方案的包含秋葵、菊粉和柠檬酸的组合物与天然产物胭脂仙人掌和壳聚糖的脂肪结合能力的图。
发明详述
在某些实施方案中,秋葵种植物为属于秋葵属的秋葵植物,更具体地,物种黄秋葵(有时还被称为菜秋葵(Hibiscus esculentus))、Abelmoschus caillei(还被称为西非秋葵)、黄蜀葵、Abelmoschus ficulneus、香葵或其任意两个或多个物种的混合物。
“可食用的”是指加工的秋葵种植物适合人或动物消耗,即能够被吃掉。因此,组合物将包括秋葵植物的可食用部分。在某些实施方案中,可食用部分包括秋葵植物的果实(即荚果)。在这样的实施方案中,可食用部分可以包括或可以不包括秋葵种子。在其他实施方案中,可食用部分基本上没有秋葵种子。“基本上没有”是指基于可食用部分的总重量,可食用部分包含按重量计小于约10%的秋葵种子,例如,按重量计小于约5%的秋葵种子,或按重量计小于约2%的秋葵种子,或按重量计小于约1%的秋葵种子,或小于约0.5wt.%的秋葵种子,或小于约0.1wt.%的秋葵种子。在某些实施方案中,秋葵种植物的可食用部分,和由此包含所述可食用部分的任何组合物完全没有秋葵种子。
在某些实施方案中,所述组合物包括加工的秋葵种植物的可食用部分。“加工的”是指秋葵植物已经通过工艺改变,例如,通过脱水或冷冻干燥改变,以使其呈现适合加入根据本发明的组合物中的形式。秋葵植物可以通过脱水(即减少水分含量)和/或尺寸细筛(sizing)改变,有利地,至少通过脱水和尺寸细筛的组合改变。“尺寸细筛”是指(任选地脱水的)秋葵植物的可食用部分经受粒径减小步骤或多个粒径减小步骤。在某些实施方案中,秋葵植物的可食用部分被脱水并且随后经尺寸细筛。加工还可以包括洗涤、漂白和/或烹饪。在脱水和/或尺寸细筛之前,可以洗涤可食用部分,例如荚果(去皮或不去皮)以去除污垢,并且修整以去除褪色或受损的组织。荚果可以被切片或以另外的方式切碎,并且可以去除种子。然后例如在干燥器或烘箱中或通过冷冻干燥等使荚果脱水,直到水分含量在期望的水平以下,例如,即小于约10%,例如,小于约5%,或小于约2%,或小于约1%的水分含量。水分含量是通过干燥失重确定的,即小于约10%的水分含量是指大于约90%的秋葵种植物的水分含量已经被除去。适合的“干燥失重”法见于欧洲药典(第8版)第2.2.32节。脱水产品然后可以被压碎、研磨、磨碎或以另外方式粉碎,以产生粒状或粉末状产品。压碎的、研磨的、磨碎的或以另外方式粉碎的产品可以经受一个或多个分类步骤,以获得具有所需粒径的粒状或粉末状产品。秋葵种植物的可食用部分可以固体形式或非固体形式,例如作为液体,例如水性液体,或作为悬浮液或分散液,例如水性悬浮液或分散液提供。
在某些实施方案中,(任选地)加工的秋葵种植物以粒状或粉末状形式使用或包括在组合物中。在某些实施方案中,如可以通过适合大小的筛确定(例如,具有适宜的美国筛目尺寸的筛),秋葵种植物的可食用部分具有小于约750μm的粒径直径,例如,等于或小于约500μm、或等于或小于约425μm、或等于或小于约355μm、或等于或小于约300μm、或等于或小于约250μm、或等于或小于约180μm、或等于或小于约150μm、或等于或小于约125μm、或等于或小于约105μm、或等于或小于约90μm的粒径直径。有利地,秋葵种植物的可食用部分具有等于或小于约180μm的粒径直径。在某些实施方案中,秋葵种植物的可食用部分具有大于约1nm,例如,大于约100nm、或大于约1μm、或大于约10μm、或大于约37μm、或大于约44μm或大于约53μm的粒径直径。在某些实施方案中,秋葵种植物的可食用部分具有等于或小于约500μm至大于约37μm,例如,等于或小于约300μm至大于约53μm、或等于或小于约250μm至大于约53μm、或等于或小于约180μm至大于约53μm、或等于或小于约150μm至大于约53μm、或等于或小于约125μm至大于约53μm、或等于或小于约150μm至大于约90μm、或等于或小于约125μ至大于约90μm的粒径直径。
在某些实施方案,例如,其中膳食脂肪吸收的减少发生在胃肠道中(例如,通过结合胃中的膳食脂肪)的实施方案中,(任选地处理的)秋葵种植物的可食用部分具有等于或小于约150μm、或等于或小于约125μm、或等于或小于约90μm的粒径直径。在某些实施方案中,秋葵种植物的可食用部分具有等于或小于约180μm至大于约150μm,或等于或小于约150μm至大于约125μm,或等于或小于约125μm至大于约90μm的粒径直径。
本文使用的表述“膳食脂肪的吸收”和类似术语是指存在于饮食中的脂肪的消化产物借助其通过肠粘膜进入血液或淋巴中的过程。膳食脂肪主要是甘油三酸酯,还包括磷脂,甾醇如胆固醇,和脂溶性维生素和矿物质。小肠还包含来自脱落的上皮细胞的脂质和胆汁中递送的胆固醇。为了使甘油三酸酯被吸收,在水性环境中几乎不溶的膳食甘油三酸酯的大的聚集体必须被物理分解并保持在悬浮液中;该过程被称为乳化。甘油三酸酯分子必须也被脂肪酶酶消化,产生甘油单酯和脂肪酸,其扩散或以另外的方式运输到肠细胞中。
加工的秋葵种植物的可食用部分包括膳食纤维。本文使用的术语“膳食纤维”具有该术语的通常含义。其通常被视为源自植物的食物的不消化部分。通常,膳食纤维有两种主要组分:溶于水的可溶性纤维,和不溶于水的不可溶性纤维。在某些实施方案中,膳食纤维包括多糖,例如非淀粉多糖,其没有被降解成胃肠道可吸收的单元。因此,在某些实施方案中,所述膳食纤维包括不能被哺乳动物,例如人的消化系统水解的多糖。认为包含在(任选地处理的)秋葵种植物的可食用部分中并且源自(任选地处理的)秋葵种植物的可食用部分的多糖截留(entrap)胃中的膳食脂肪或以另外方式与胃中的膳食脂肪结合,形成不可消化的多糖-脂肪复合物,其作为废物从身体排出。多糖与膳食脂肪复合的能力至少部分是由于多糖在小肠中膨胀的能力。总体效果是降低身体吸收膳食脂肪的能力,其减少热量摄入,进而可以导致重量减轻,并且从而导致障碍如肥胖和代谢性疾病如代谢综合征,和与其相关的任何症状的缓解。因此,包含秋葵种植物的可食用部分的组合物通过与胃中的膳食脂肪结合,以使结合的物质不能被胃中的脂肪酶消化,太大而不能被身体吸收,因此作为废物从身体排出来减少膳食脂肪的吸收。因此,有利地,包含秋葵种植物的可食用部分的组合物在膳食脂肪将以另外的方式被分解并输送到小肠之前作用于胃中的膳食脂肪并与胃中的膳食脂肪结合,在小肠内膳食脂肪通常在消化过程期间将受到胆汁酸的作用。
(任选地处理的)秋葵种植物的可食用部分(具有减少膳食脂肪吸收的活性)可以以包含任何适合的另外的组分的组合物的形式给予。组合物可以例如是适合口服给予(例如片剂、胶囊、粉末、液体等)的药物组合物(药物)。组合物可以供选择地例如为食品、食品补充剂、膳食补充剂、代餐产品、饮料或饮料补充剂。
在本发明的上下文中的术语“药物组合物”或“药物”是指包含(任选地处理的)秋葵种植物的可食用部分和包含另外的一种或多种药学上可接受的载体的组合物。所述组合物还可以根据给予模式的性质和剂型包含选自以下的成分:例如,稀释剂、佐剂、赋形剂、溶媒、防腐剂、填充剂、崩解剂、润湿剂、乳化剂、助悬剂、甜味剂、调味剂、芳香剂、抗菌剂、抗真菌剂、润滑剂和分散剂。组合物可以呈现以下形式:例如,片剂、胶囊、糖衣丸、锭剂、颗粒剂、散剂、丸剂和扁囊剂;液体制剂,包括酏剂、糖浆剂、混悬剂、喷雾剂、乳剂和溶液剂。技术和配方通常可以见于Remington,The Science and Practice of Pharmacy,MackPublishing Co.,Easton,PA,最新版。
在用于口服给予的本发明的固体剂型中,(多种)活性成分可以与一种或多种药学上可接受的载体如磷酸氢钙和/或任意以下混合:稀释剂、填充剂或增量剂,如淀粉、乳糖、蔗糖、葡萄糖、甘露醇、微晶纤维素和/或硅酸;粘合剂,如羟丙基纤维素、羟丙基甲基纤维素、羧甲基纤维素、明胶、聚乙烯吡咯烷酮、聚醋酸乙烯酯、蔗糖和/或阿拉伯胶;崩解剂,如淀粉,例如,马铃薯或木薯淀粉,淀粉衍生物,如羧基乙酸淀粉钠、交联聚乙烯吡咯烷酮、碳酸钙、交联甲基纤维素钠、藻酸和某些硅酸盐;润滑剂,如滑石、硬脂酸钙、硬脂酸镁、硬脂酸、硫酸钠、富马酸钠、固体聚乙二醇;增溶剂,如月桂基硫酸钠;矫味剂和着色剂;及其混合物。
本发明的药物组合物的片剂和其他固体剂型可以任选地制备成带有包衣和外壳,如肠溶包衣和药物制剂领域熟知的其他包衣。其还可以使用以下配制以便提供其中的(多种)活性成分的缓释或控释:例如不同比例的天然和合成聚合物如甲基丙烯酸羟丙基甲基纤维素以提供期望的释放曲线;还可以使用其他聚合物基质,脂质体和/或微球。这些组合物还可以任选地包含着色剂和/或遮光剂,并且可以是任选地以延迟的方式仅在或优先地在胃肠道的某部分释放(多种)活性成分的组合物。
液体形式制剂包括溶液、混悬剂和乳剂。例如,用于口服给予的水或水-丙二醇溶液。液体制剂还可以配制成在水性聚乙二醇溶液中的溶液。在某些实施方案中,(多种)活性成分即包括加工的秋葵种植物的可食用部分,可以与一种或多种药学上可接受的载体如水和/或任何以下混合:溶剂,如丙二醇、乙醇;湿润剂,如甘油;甜味剂,如液体葡萄糖、玉米糖浆和蔗糖;人工甜味剂,如阿斯巴甜、甜菊糖和蔗糖素;防腐剂,如苯甲酸酯和对羟基苯甲酸酯;粘度调节剂/增稠剂,如树胶和藻酸盐;缓冲剂;矫味剂和着色剂。
还包括固体形式制剂,其旨在在使用前不久被转化为用于口服给予的液体形式制剂。这样的液体形式包括溶液、混悬剂和乳剂。这些具体的固体形式制剂最便利地以单位剂型提供,因此用于提供单一液体剂量单位。供选择地,可以提供足够的固体以使在转化为液体形式之后,可以通过使用勺子或其他测量装置测量预定量体积的固体形式制剂获得多个单一液体剂量。要转化成液体形式的固体形式制剂除了活性物质以外可以包含调味剂、着色剂、稳定剂、缓冲剂、人工和天然甜味剂、分散剂、增稠剂、增溶剂等。用于制备液体形式制剂的液体可以是水、等渗水、果汁、牛奶、乙醇等以及其混合物。
本文使用的术语“食物”、“食品”、“食品补充剂”、“膳食补充剂”、“健康补充剂”、“代餐产品”、“饮料”和“饮料补充剂”具有那些术语通常的含义,并且不限于药物制剂。其他组合物形式也包括在本发明内。这些可以例如包括食品前体,如可再水合的粉末或饮料前体,如可分散在水、牛奶或其他液体中的粉末。
还包括要在口服消耗前与食物或食品组合的固体形式制剂。固体形式制剂可以混合到食物或食品中或施加到食物或食品,例如,通过喷洒到食物或食品上。这样的固体形式包括粉末、颗粒、丸粒等。这样的食物或食品包括但不限于,预制食品(烹制的或新鲜的)、汤、乳制品(例如,酸奶、奶油、鲜奶油)、基于面粉的产品如面包和面食、零食或便利品如零食棒(例如,巧克力棒)、糖果产品等。
在某些实施方案中,食物或食品等包括基于食物或食品的总重量约0.1wt.%至约50wt.%的本文所述的本发明的组合物,例如,约0.1wt.%至约40wt.%,或约0.1wt.%至约30wt.%,或约0.1wt.%至约20wt.%,或约0.1wt.%至约15wt.%,或约0.1wt.%至约10wt.%,或约0.1wt.%至约8wt.%,或约0.1wt.%至约6wt.%,或约0.1wt.%至约4wt.%,或约0.1wt.%至约2wt.%的本文所述的本发明的组合物。在某些实施方案中,食物或食品等包括基于食物或食品的总重量的至少约0.2wt.%的本文所述的本发明的组合物,例如,至少约0.5wt.%,或至少约1wt.%,或至少约5wt.%的本文所述的本发明的组合物。
在某些实施方案中,所述组合物每日口服给予受试者。为了实现膳食脂肪吸收的减少,组合物将与包含膳食脂肪的餐食组合服用。根据口服剂型的性质,希望将组合物随餐或餐后服用;例如,胶囊或片剂可以在餐后约15分钟至一小时给予,例如,餐后30分钟至一小时,或餐前15分钟至30分钟或餐后30分钟至45分钟。
给予的组合物的量可以根据受试者的需要和所消耗的食物或饮食中的脂肪或多种脂肪的量变化。对于治疗性应用,给予的组合物的量可以根据受试者的需要、治疗的病症的严重性和所消耗的食物或饮食中的脂肪或多种脂肪的量变化。确定用于特定情形的适合的量/剂量在本领域技术范围内。例如,对于治疗性应用,具有本领域普通技术的医师或兽医可以容易地确定并开具有效量的需要的药物组合物。如果需要,每日总量/剂量可以在日间划分并随餐按份给予。
一般地,根据本发明的组合物的适合的每日剂量将为这样的组合物的量,其为有效产生期望效果,例如治疗效果和/或减少膳食脂肪吸收的最低剂量。由于组合物的非毒性性质,考虑可以使用宽剂量范围。例如,剂量可以高达7.5g每天。剂量涉及加工的秋葵种植物的可食用部分的量。在某些实施方案中,剂量在每天100mg至约7.5g的范围内,其可以在一整天内作为两个或三个或多个亚剂量以适宜的间隔分开给予(例如,在每餐后),任选地以单位剂型给予。在某些实施方案中,剂量可以为每天约200mg至约5g,例如,每天约500mg至约3g,或每天约750至约2g,或每天约1000mg至约1750mg,或每天约1000mg至约1500mg。在某些实施方案中,组合物可以每天给予二或三次,任选地随餐或餐后给予。因此,剂量可以为每餐至少约100mg,或每餐至少约250mg,或每餐至少约500mg,或每餐至少约750mg,或每餐约1000,或每餐至少约1250mg,或每餐至少约1500mg。在某些实施方案中,每餐的剂量不超过约2.5g,例如,不超过约2g,例如不超过约1750mg。
在其中加工的秋葵种植物的可食用部分以组合物的形式给予的某些实施方案中,基于组合物的总重量,加工的秋葵种植物的可食用部分的量包含按重量计组合物的至少约5%,例如,按重量计至少约10%,或按重量计至少约15%,或按重量计至少约20%,或按重量计至少约25%,或按重量计至少约30%或按重量计至少约35%,或按重量计至少约40%,或按重量计至少约45%,或按重量计至少约50%,或按重量计至少约55%,或按重量计至少约60%,或按重量计至少约65%,或按重量计至少约70%,或按重量计至少约75%,或按重量计至少约80%,或按重量计至少约85%,或按重量计至少约90%,或按重量计至少约95%或按重量计至少约99%。在某些实施方案中,基于所述组合物的总重量,组合物包含按重量计约1%至约99%的加工的秋葵种植物的可食用部分,例如,按重量计约5%至约90%,或按重量计约10%至约80%,或按重量计约10%至约70%,或按重量计约10%至约60%,或按重量计约15%至约50%,或按重量计约20%至约50%,或按重量计约20%至约40%的加工的秋葵种植物的可食用部分。
在其中秋葵种植物的可食用部分被加入用于给予的组合物的实施方案中,组合物可以包含另外来源的膳食纤维,即除了源自秋葵种植物的那些以外的膳食纤维和/或除了果聚糖以外的膳食纤维,如本文所述。另外来源的膳食纤维可以包含不溶性纤维或可溶性纤维,或不溶性或可溶性纤维的混合物。
在某些实施方案中,组合物包含:一种或多种可溶性纤维,其选自壳聚糖、阿拉伯胶、瓜尔豆胶、低甲氧基和高甲氧基果胶、燕麦和/或大麦β-葡聚糖、角叉菜胶、车前草、环糊精及其衍生物;和/或一种或多种不溶性纤维,其选自燕麦壳纤维、豌豆壳纤维、大豆壳纤维、大豆子叶纤维、甜菜纤维、纤维素、玉米麸及其衍生物。
在某些实施方案中,组合物包含壳聚糖和任选地一种或多种以上刚描述的可溶性和/或不溶性纤维。壳聚糖是由无规分布的β-(1-4)-连接的D-葡萄糖胺(脱乙酰单元)和N-乙酰基-D-葡萄糖胺(乙酰化单元)构成的线性多糖。其可以通过使用碱,如氢氧化钠处理虾和其他甲壳类动物壳制造。另外地或供选择地,壳聚糖由真菌几丁质制造(参见例如,Berecochea-Lopez等人,J.Agric.,Food Chem.,2009,57,p1093-1098)。
在某些实施方案中,基于所述组合物总重量,组合物可以包含按重量计约0.1至约90%的另外来源的膳食纤维,例如,按重量计约1%至约80%,或按重量计约5%至约70%,或按重量计约10%至约60%,或按重量计约20%至约50%的另外来源的膳食纤维。
在某些实施方案中,组合物还包含果聚糖和有机酸,如三羧酸。在某些实施方案中,果聚糖为菊粉和/或海葱糖。优选地,果聚糖为菊粉。菊粉是由许多类型的植物例如菊苣产生的天然存在的多糖。菊粉的特征是在多糖内的果糖基残基通过β-2,1键连接。在某些实施方案中,有机酸为三羧酸、苹果酸、富马酸、酒石酸、乳酸、抗坏血酸或其混合物。适合的三羧酸可以选自柠檬酸、异柠檬酸、乌头酸、丙三酸及其混合物。在某些实施方案中,三羧酸为柠檬酸。有利地,组合物还包含菊粉和柠檬酸。在某些实施方案中,组合物包含约0.5wt.%至约50wt.%的果聚糖(例如,菊粉)和约0.5wt.%至约20wt.%的有机酸(例如,三羧酸,如柠檬酸)。在某些实施方案中,组合物包含约5wt.%至约45wt.%的果聚糖(例如,菊粉)和约1wt.%至约15wt.%的有机酸(例如,三羧酸,如柠檬酸),或约15wt.%至约40wt.%的果聚糖(例如,菊粉)和约5wt.%至约15wt.%的有机酸(例如,三羧酸,如柠檬酸),或约25wt.%至约40wt.%的果聚糖(例如,菊粉)和约7wt.%至约12wt.%的有机酸(例如,三羧酸,如柠檬酸),或约25wt.%至约35wt.%的果聚糖和约8wt.%至约10wt.%的有机酸(例如,三羧酸,如柠檬酸)。
在某些实施方案中,包括本发明的包含果聚糖和有机酸的组合物的本发明的组合物包含选自维生素和矿物质及其组合的营养成分。维生素可以是维生素A、维生素D、维生素E、维生素K、硫胺素、核黄素、吡哆醇、维生素B12、类胡萝卜素(β-胡萝卜素、玉米黄质、叶黄素和番茄红素)、烟酸、叶酸、泛酸、生物素、维生素C、胆碱、肌醇及其盐和衍生物中的任何一种或多种。矿物质可以是钙、磷、镁、铁、锌、锰、铜、钴、硼、碘、钠、钾、钼、硒、铬、氟和氯中的任何一种或多种。如果存在,在某些实施方案中,基于所述组合物的总重量,组合物包含按重量计约0.001%至约50%的维生素(或多种维生素)和/或矿物质(多种矿物质),例如,基于所述组合物的总重量,按重量计约0.5%至约40%,或按重量计约0.5%至约30%,或按重量计约0.5%至约20%,或按重量计约0.5%至约10%,或按重量计约0.5%至约5%,或按重量计约0.5%至约3%,或按重量计约0.1%至约2%,或按重量计约0.1至约1%的维生素(或多种维生素)和/或矿物质(多种矿物质)。在某些实施方案中,基于所述组合物的总重量,组合物包含约0.001%至约5wt.%,例如,约0.001至约2wt.%,或约0.001至约1wt.%,或约0.001至约0.5wt.%,或约0.001至约0.1wt.%,或约0.001至约0.01wt.%的维生素(或多种维生素)和/或矿物质(多种矿物质)。
在某些实施方案中,本发明的组合物包含其他生物活性剂,例如,适合治疗肥胖和/或代谢性疾病如代谢综合征的生物活性剂。在某些实施方案中,生物活性剂选自:吸收改变剂,包括脂肪酶抑制剂,例如奥利司他和西替利司他;脂肪结合剂,例如脱水梨果仙人掌(Opuntia ficus indica)叶状茎粉末和壳聚糖;α-淀粉酶抑制剂,例如白芸豆提取物和多酚;α-葡糖苷酶抑制剂,例如阿卡波糖、L-阿拉伯糖和多酚;食欲改变剂,包括药剂,例如西布曲明、苯丁胺、安非拉酮、利莫那班和苄非他明;和营养剂,例如马铃薯提取物和蛋白;代谢改变剂,例如莫索尼定、绿茶提取物、枳实(Citrus aurantium)提取物或藤黄果(Garcinia cambogia)提取物;胆固醇减少剂,包括他汀类,例如阿托伐他汀、辛伐他汀、洛伐他汀、普伐他汀、罗苏伐他汀等;贝特类例如吉非贝齐、苯扎贝特、非诺贝特或环丙贝特;胆汁酸螯合剂,例如考来替泊、考来烯胺;营养素,例如植物甾醇;或其任意组合。在某些实施方案中,基于所述组合物的总重量,生物活性剂或多种生物活性剂以约0.001wt.%至约20wt.%的量,例如,约0.1wt.%至约15wt.%,或约0.5wt.%至约10wt.%,或约0.5wt.%至约5wt.%,或约0.1wt.%至约3wt.%,或约0.1wt.%至约2wt.%,或约0.1wt.%至约1wt.%,或约0.001wt.%至约5wt.%,或约0.001wt.%至约2wt.%,或约0.001wt.%至约1wt.%,或约0.001wt.%至约0.5wt.%,或约0.001wt.%至约0.1wt.%,或约0.001wt.%至约0.01wt.%的量存在于组合物中。
本发明的组合物可以通过以适合的量将加工的秋葵种植物的可食用部分与一种或多种本文所述的其他成分组合,以获得具有期望量的每种组分的组合物来制备,所述其他成分即果聚糖和有机酸(例如,三羧酸),另外来源的膳食纤维,和/或维生素(或多种维生素),和/或矿物质,和/或其他生物活性剂。
在某些实施方案中,通过混合(任选地处理的)秋葵种植物的可食用部分和任何一种或多种本文所述的另外的成分来制备(任选地处理的)秋葵种植物的可食用部分与任何一种或多种本文所述的另外的成分的混合物。这样的方法是本领域熟知的,例如,食品工业中已知的方法,如用于制备健康食品棒等的那些。该方法还可以包括成形步骤,其中将混合物模制、压制、喷雾干燥或以另外的方式成形为例如棒、球、丸粒或团簇(例如,在早餐谷物中存在的类型的团簇,等等)的形状,优选地具有适合人或本文所述的类型的其他哺乳动物口服消耗的尺寸。
在某些实施方案中,(任选地处理的)秋葵植种物的可食用部分的组合物可以通过包括以下的方法制备:
(a)洗涤;
(b)切片;
(c)在优化温度和湿度下干燥;和
(d)磨碎以降低干燥混合物的粒径,以获得粉末形式。
任选地,秋葵的粉末形式可以与一种或多种本文所述的另外的成分混合,以获得具有(任选地处理的)秋葵种植物的可食用部分与一种或多种另外的成分的组合物。
供选择地,组合物可以通过包括以下的方法制备:
(a)将(任选地处理的)秋葵种植物的可食用部分与一种或多种本文所述的另外的成分混合;
(b)添加水;
(c)使湿的混合物经受剪切力,任选地在环境温度下,以将该混合物匀质化;
(d)干燥所述均质化的混合物以降低水含量,例如,以将水含量减少至5wt.%或以下,和任选地
(e)减少干燥混合物的粒径。
在某些实施方案中,步骤(c)中的剪切力可以通过高剪切混合器适当地施加。其他适合的装置包括搅拌机和双螺杆捏合机,其可以具有工作台、实验室或工业规模。粒径减少的步骤或多个粒径减少的步骤可以借助磨碎、研磨或筛分或这些方法的组合进行。筛分将使用适合尺寸的筛网来进行。所述方法还可以包括成形步骤,其中将(任选地粒径减少的)混合物模制、压制、喷雾干燥或以另外的方式成形为例如棒、球、丸粒或团簇(例如,在早餐谷物中存在的类型的团簇,等等)的形状,优选地具有适合人或本文所述的类型的其他哺乳动物口服消耗的尺寸。
在其他实施方案中,(任选地处理的)秋葵种植物的可食用部分与一种或多种本文所述的另外的成分的简单混合物可以通过本领域熟知的方法制备,例如,食品工业中已知的方法,如用于制备健康食品棒等的那些。如上所述,该方法还可以包括成形步骤,其中将混合物模制或压制或以另外的方式成形为例如棒、球、丸粒或团簇(例如,在早餐谷物中存在的类型的团簇,等等)的形状,优选地具有适合人或本文所述的类型的其他哺乳动物口服消耗的尺寸。
在上述的制备方法的某些实施方案中,所述方法还包括制备处理的秋葵种植物的可食用部分,其中秋葵果实(荚果)通过至少脱水,以及如本文在以上所述的在适宜时尺寸细筛的组合改变。
除了用于人应用和治疗,本发明还用于一系列哺乳动物,所述哺乳动物也可以被肥胖和体重增加影响。这样的哺乳动物包括例如在动物园中的非人灵长类(例如猩猩、猴子和狐猴),宠物如猫或狗,工作和运动动物如狗、马和小马,农场动物,例如猪、绵羊、山羊、鹿、公牛和家牛,和实验室动物如啮齿动物(例如兔、大鼠、小鼠、仓鼠、沙鼠或豚鼠)。
在某些实施方案中,包含秋葵种植物的可食用部分、果聚糖和有机酸,如三羧酸(例如,菊粉和柠檬酸)的组合物在治疗或预防受试者的肥胖的方法中使用。在某些实施方案中,受试者未患上肥胖,或尚未诊断出患有肥胖,但易患肥胖。肥胖的治疗或预防基于包含秋葵种植物的可食用部分的组合物减少主要在或仅在受试者的胃肠道中的膳食脂肪的吸收的能力。如以上所讨论的,这是基于包含秋葵种植物的可食用部分的组合物结合胃中的膳食脂肪,从而减少或甚至防止机体吸收膳食脂肪的发现。
在某些实施方案中,包含秋葵种植物的可食用部分、果聚糖和有机酸,如三羧酸(例如,菊粉和柠檬酸)的组合物在治疗或预防受试者的代谢性疾病(例如,代谢综合征)的方法中使用。在某些实施方案中,受试者未患上代谢性疾病,例如未患上代谢综合征,或尚未诊断出患有代谢性疾病(例如,代谢综合征),但易患代谢性疾病(例如,代谢综合征)。
本文使用的表述“治疗或预防”和类似术语是指旨在消除或避免障碍或减轻其症状的所有形式的医疗保健,包括预防性和治疗性护理,如根据普遍的医疗实践可用的任何测试所判断的。在“治疗或预防”的表述中包含了目标是以合理的预期实现具体结果但不总能实现具体结果的干预。成功减缓或阻止障碍进展的干预包括在“治疗或预防”的表述中。
本文使用的表述“易患”和类似术语具体是指处于比患上肥胖和/或代谢综合征的正常风险更高的风险下的个体,如使用已知的个体或肥胖/代谢综合征的风险因素评估的。这样的个体可以例如被分类为具有相当大的患上肥胖和/或代谢综合征的风险,达到将对该个体开具药物和/或进行特殊膳食、生活方式或类似建议的程度。
在某些实施方案中,受试者为人。在其他实施方案中,受试者为如上所述的也可以受到肥胖和体重增加的影响的除人以外的哺乳动物。
肥胖是医学病症,其中过多的身体脂肪已经聚集到对健康可能具有不良影响的程度,导致减少的预期寿命和/或增加的健康问题。当受试者的体质指数(BMI)超过30kg/m2时被认为肥胖,所述体质指数(BMI)是通过将人的以千克计的体重除以该人的以米计的身高的平方获得的量度。
肥胖增加各种疾病,尤其是心脏病、2型糖尿病、阻塞性睡眠呼吸暂停、某些类型的癌症和骨关节炎的可能性。
BMI通过将受试者的质量除以他/她的身高的平方计算,通常以公制单位表示:
BMI=以千克计的体重/(以米计身高)2
由世界卫生组织(WHO)在1997年建立并在2000年出版的最常用的定义提供了下表中列出的值。
BMI | 分类 |
<18.5 | 体重过轻 |
18.5-24.9 | 正常体重 |
25.0-29.9 | 超重 |
30.0-34.9 | I级肥胖 |
35.0-39.9 | II级肥胖 |
≥40.0 | III级肥胖 |
代谢综合征是当一起发生时增加受试者患上疾病如心血管疾病和糖尿病的风险的医学障碍的组合。代谢综合征也称为代谢综合征X、心脏代谢综合征、综合征X、胰岛素抵抗综合征、Reaven综合征(以Gerald Reaven命名)和CHAOS(在澳大利亚)。
代谢综合征有如下许多不同的定义:
代谢综合征的国际糖尿病联合会(International Diabetes Federation)共认的世界范围内的定义(2006)是:向心性肥胖(定义为腰围具有种族特异性值)和以下任意两项:
●升高的甘油三酸酯:>150mg/dL(1.7mmol/L),或针对该脂质异常的具体治疗
●减少的HDL胆固醇:男性<40mg/dL(1.03mmol/L),女性<50mg/dL(1.29mmol/L),或针对该脂质异常的具体治疗
●升高的血压(BP):收缩BP>130或舒张BP>85mm Hg,或先前诊断的高血压的治疗
●升高空腹血糖(FPG):>100mg/dL(5.6mmol/L),或先前诊断的2型糖尿病
如果受试者的BMI大于30kg/m2,可以假设为向心性肥胖,并且不需要测量腰围。
世界卫生组织标准(1999)要求存在糖尿病、糖耐量受损、空腹血糖受损或胰岛素抵抗中任一项,以及以下两项:
●血压:≥140/90mm Hg
●血脂异常:甘油三酯(TG):≥1.695mmol/L和高密度脂蛋白胆固醇(HDL-C)≤0.9mmol/L(男性),≤1.0mmol/L(女性)
●向心性肥胖:腰臀比>0.90(男性);>0.85(女性),或体质指数>30kg/m2
●微量白蛋白尿:尿白蛋白排泄率≥20μg/min或白蛋白:肌酐比≥30mg/g
胰岛素抵抗研究的欧洲组(1999)要求胰岛素抵抗定义为非糖尿病个体中的空腹胰岛素值的前25%,以及以下任意两项或多项:
●向心性肥胖:腰围≥94cm(男性),≥80cm(女性)
●血脂异常:TG≥2.0mmol/L和/或HDL-C<1.0mmol/L或针对血脂异常治疗过
●高血压:血压≥140/90mmHg或抗高血压药物
●空腹血糖≥6.1mmol/L
美国国家胆固醇教育计划成人治疗小组III(US National CholesterolEducation Program Adult Treatment Panel III)(2001)要求至少以下三项:
●向心性肥胖:腰围≥102cm或40英寸(男性),≥88cm或36英寸(女性)
●血脂异常:TG≥1.7mmol/L(150mg/dl)
●血脂异常:HDL-C<40mg/dL(男性),<50mg/dL(女性)
●血压≥130/85mm Hg,或针对高血压治疗过
●空腹血糖≥6.1mmol/L(110mg/dl)
在某些实施方案中,代谢综合征为根据国际糖尿病联合会(InternationalDiabetes Federation)共认的世界范围内的代谢综合征的定义(2006)所定义的。
在某些实施方案中,代谢综合征为根据世界卫生组织标准(1999)所定义的。
在某些实施方案中,代谢综合征为根据胰岛素抵抗研究的欧洲组(1999)所定义的。
在某些实施方案中,代谢综合征为根据美国国家胆固醇教育计划成人治疗小组III(2001)所定义的。
根据本文所述的本发明的治疗性方法和应用,给予有效量的包含(任选地处理的)秋葵种植物的可食用部分的组合物,以便于治疗或预防肥胖和/或代谢性疾病(例如,代谢综合征)。有效量将被理解为有效治疗或预防肥胖和/或代谢性疾病(例如,代谢综合征)的量,即产生治疗效果的量。有效量包括上述的任何剂量、用量或给药方案,其各自涉及(任选地处理的)秋葵种植物的可食用部分的量,并且在某些实施方案中,涉及果聚糖(例如,菊粉)和有机酸如三羧酸(例如,柠檬酸)的量。出乎意料地,已经发现与单独的每种物质的膳食脂肪吸收能力相比,秋葵种植物的可食用部分、果聚糖(优选为菊粉)和有机酸如三羧酸(优选为柠檬酸)的组合提供了组合物的膳食脂肪吸收能力的协同改善。这意味着可以提高秋葵种植物的可食用部分的膳食脂肪吸收性能。这进而意味着原则上可以使用更少的秋葵获得相同的效果。
如本文所述的包含(任选地处理的)秋葵种植物的可食用部分的组合物可以在管理受试者的体重的方法中使用。这样的方法基本上是非治疗性的,因为其不减轻或不治疗可治疗的障碍,而是使受试者保持健康的体重(例如,18.5-24.9的BMI),或使超重的受试者(例如,BMI为25.0-29.9的受试者)减少其体重(即减少其BMI),优选地减少至健康体重,或以另外的方式来减少、最小化、改善或预防受试者的体重增加。
一般地,包含(任选地处理的)秋葵种植物的可食用部分的组合物的适合的每日剂量将为这样的量的组合物,该量是有效产生希望程度或类型的体重管理的最低剂量。在某些实施方案中,上述剂量、用量和给药方案将适合于管理受试者的体重的方法。本领域普通技术人员将理解,适合的剂量或用量将通常在受试者与受试者之间变化,并且将取决于如膳食习惯和在开始给予包含(任选地处理的)秋葵植种物的可食用部分的组合物时受试者的健康状况的严重程度等因素。例如,与寻求减少其体重的过重的受试者相比,寻求保持健康体重的受试者可能需要消耗更少量的包含(任选地处理的)秋葵种植物的可食用部分的组合物。高脂肪饮食的受试者可能需要消耗更高剂量的包含(任选地处理的)秋葵种植物的可食用部分的组合物。管理体重的方法可以与其他常规的减肥措施,例如,增加体力活动和/或健康或更健康的饮食组合。
现在将以仅参考以下非限定性实例的方式详细描述本发明。
实施例
实施例1脂肪结合测试-方法、材料和装置
根据下述程序确定秋葵粉末的脂肪结合功效(参见(d)中的测试方法)。以相同的方式测试许多已知产品的脂肪结合功效(参见比较例A、B、C和D),并与秋葵粉末的脂肪结合功效比较。测试是对胃肠道中的体内膳食脂肪吸收的预测(即在基本上不存在胆汁盐的情况下)。
(a)材料和设备
-分析级葵花油(Sigma)
-Trizma碱,纯度≥99%(Sigma)
-37%HCl
-离心机(角转子)
-水浴
(b)缓冲液制备
pH 6.8的缓冲液:
-将120g的Trizma碱添加到烧杯中
-将49.0ml的HCl 37%(或相当于12M HCl)添加到烧杯中
-加满水至200ml
-使用HCl 37%调节pH至6.8
(c)秋葵粉末制备
将秋葵荚果切片,并在55-85℃的烘箱中干燥以使水分含量减少至小于10%。随后将干燥的材料研磨成粉末并通过125μm(120美国目)筛。通过125μm筛的材料用于实施例中。
(d)测试方法
将25ml的pH 2缓冲液添加到离心管中。随后添加12.0g苏丹(III)红饱和的葵花油制剂,接着添加0.30g的秋葵粉末。剧烈振摇管并在37℃下孵育2小时。
孵育后,将5ml的pH 6.8缓冲液添加到离心管,用盖将其盖紧。温和地混合内容物。然后将管离心10分钟。
使用微量移液管,将从离心管回收葵花油并称重。
将秋葵粉末的脂肪结合能力计算为未回收的葵花油的质量和在实验期间使用的秋葵粉末的质量之间的比,即,
脂肪结合能力=(使用的葵花油的质量(g)-回收的葵花油的质量)/秋葵粉末的质量。
比较例A
比较例B
比较例C
按照实施例1中的程序,不同之处在于使用0.3g具有85%的乙酰化程度(DAC)的食品级(动物)壳聚糖粉末(由RongCheng LuYang Biological Technology Co.,Ltd.生产)代替秋葵粉末。在测试前将动物壳聚糖粉末通过125μm筛。
比较例D
(e)结果
确定测试的秋葵粉末具有40g脂肪/g秋葵粉末的脂肪结合能力。
秋葵粉末的脂肪结合能力与比较例A、B、C和D中测试的物质的脂肪结合能力比较。比较总结在图1中。
脂肪结合比较=(比较例的脂肪结合能力/秋葵的脂肪结合能力)×100。
实施例2脂肪吸收能力
进一步测试来自实施例1的秋葵粉末、胭脂仙人掌叶状茎粉末动物壳聚糖粉末和植物壳聚糖粉末的脂肪吸收能力。还测试了菊粉和柠檬酸的脂肪吸收能力,以及上述粉末与(i)菊粉、(ii)柠檬酸、(iii)菊粉和柠檬酸组合的脂肪吸收能力。
脂肪吸收能力计算如下:
脂肪吸收能力=[(使用的葵花油的量-回收的葵花油的量)/使用的油的量]×100%。
对于包含粉末和菊粉的测试样品,包括0.15g的菊粉。
对于包含粉末、菊粉和柠檬酸的测试样品,包括0.15g菊粉以及包括0.05g柠檬酸。
对于仅包含菊粉的测试样品,将0.600g菊粉与20g葵花油混合。对于仅包含柠檬酸的测试样品,将0.600g柠檬酸与20g葵花油混合。对于仅包含菊粉和柠檬酸的测试样品,将0.150g菊粉和0.050g柠檬酸与20g葵花油混合。
结果总结在图2和3中。
实施例3固体制剂配方
表1显示了仅包含秋葵以及添加了菊粉和柠檬酸的片剂的组成。
表1
针对2000片的批量大小根据以上配方分配成分。项目1通过筛目尺寸100#过筛,而项目2至5通过筛目30#过筛。将项目1与项目6预混合并在实验室级圆筒混合机中共混2分钟。随后将项目2至5添加到预混合物中,并均质共混10分钟。项目7通过筛目60#过筛,然后与共混物润滑2分钟。将共混物压成重量为870mg的椭圆形片。然后使用项目8对压制片进行包衣,直到达到3%的增重。
Claims (19)
1.一种用于减少受试者的膳食脂肪吸收的组合物,其基于所述组合物总重量,包含与0.5wt.%至50wt.%的果聚糖和0.5wt.%至20wt.%的三羧酸组合的1wt.%至99wt.%的秋葵种植物的可食用部分。
2.根据权利要求1所述的组合物,其中所述果聚糖为菊粉。
3.根据权利要求2所述的组合物,其中基于所述组合物总重量,所述组合物包含20wt.%至99wt.%的秋葵种植物的可食用部分,0.5wt.%至50wt.%的菊粉,和0.5wt.%至20wt.%的三羧酸。
4.根据权利要求3所述的组合物,其中基于所述组合物总重量,所述组合物包含40wt.%至80wt.%的秋葵种植物的可食用部分,2wt.%至40wt.%的菊粉,和5wt.%至15wt.%的柠檬酸。
5.根据权利要求1至4中任一项所述的组合物,其中所述组合物包含源自秋葵种植物的多糖。
6.根据权利要求5所述的组合物,其中所述多糖为非淀粉多糖,其不被降解为胃或小肠可吸收的单元。
7.根据权利要求1至4中任一项所述的组合物,其中所述组合物还包含除了源自秋葵种植物的膳食纤维以外的另外来源的膳食纤维。
8.根据权利要求1至4中任一项所述的组合物,其中所述秋葵种植物属于秋葵属。
9.根据权利要求8所述的组合物,其中所述秋葵种植物为黄秋葵、Abelmoschuscaillei、黄蜀葵、Abelmoschus ficulneus、香葵或其任意两个或多个种的混合物。
10.根据权利要求1至4中任一项所述的组合物,其中所述秋葵种植物的可食用部分呈颗粒或粉末形式。
11.根据权利要求10所述的组合物,其中所述秋葵种植物的可食用部分具有低于180μm的粒径直径。
12.根据权利要求1至11中任一项所述的组合物在制备用于减少受试者的膳食脂肪吸收的药物中的用途。
13.根据权利要求1至11中任一项所述的组合物在制备用于治疗或预防人或动物受试者的肥胖的药物中的用途。
14.根据权利要求1至11中任一项所述的组合物在制备用于治疗或预防人或动物受试者的代谢性疾病的药物中的用途。
15.一种用于减少受试者的膳食脂肪吸收的非治疗性方法,所述方法包括给予有效量的如权利要求1至11中任一项所述的组合物。
16.一种用于管理受试者的体重的非治疗性方法,所述方法包括给予有效量的如权利要求1至11中任一项所述的组合物。
17.根据权利要求16所述的方法,其中所述受试者的体重被控制、维持或减少。
18.一种食品、或食品补充剂、或膳食补充剂、或代餐产品、或饮料、或饮料补充剂,其包含如权利要求1至11中任一项所述的组合物。
19.一种药物组合物,其包含如权利要求1至11中任一项所述的组合物以及一种或多种载体和/或赋形剂。
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EP3096767A1 (en) | 2016-11-30 |
HUE038742T2 (hu) | 2018-11-28 |
EA201691436A1 (ru) | 2016-11-30 |
JP6526021B2 (ja) | 2019-06-05 |
US9943557B2 (en) | 2018-04-17 |
PL3096767T3 (pl) | 2018-10-31 |
AU2015206896B2 (en) | 2020-01-30 |
MX2016009278A (es) | 2016-12-20 |
EA033540B1 (ru) | 2019-10-31 |
CY1121176T1 (el) | 2020-05-29 |
US20160331795A1 (en) | 2016-11-17 |
DK3096767T3 (en) | 2018-08-13 |
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