CN100364451C - 包含短链和长链脂肪酸的组合物及其用于控制体重的方法 - Google Patents
包含短链和长链脂肪酸的组合物及其用于控制体重的方法 Download PDFInfo
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- CN100364451C CN100364451C CNB038090813A CN03809081A CN100364451C CN 100364451 C CN100364451 C CN 100364451C CN B038090813 A CNB038090813 A CN B038090813A CN 03809081 A CN03809081 A CN 03809081A CN 100364451 C CN100364451 C CN 100364451C
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Abstract
本文描述了适于口服的包含短链和长链脂肪酸的组合物,其中所述组合物可用于控制体重。例如,如所述,通过使用本发明组合物诱发饱腹感可有效地控制体重。具体地讲,所述组合物包含:(a)短链脂肪酸组分,所述短链脂肪酸组分选自乙酸、丙酸、丁酸和它们的酯、它们的盐以及它们的混合物;和(b)长链脂肪酸组分,所述长链脂肪酸组分选自长链脂肪酸、长链脂肪酸的非甘油酯以及它们的混合物;其中所述组合物适于哺乳动物口服。还描述了使用本发明组合物来控制体重的方法。
Description
发明领域
本发明涉及用于控制体重的组合物。具体地讲,本发明组合物可以是多种形式,包括食品、饮料、药片、胶囊、乳液和其他口服形式。本组合物用于治疗哺乳动物,例如人类和作为伴侣的动物。
发明背景
美国大众的肥胖发病率在过去十年中显著增高,超过50%的人口被认为超重或肥胖。在其他采用所谓“西式饮食”的国家也观察到了类似的趋势。由于肥胖经常伴随许多并发症,如糖尿病、高血压和动脉硬化症,所以这种发病率的增高是一个严重的健康问题。
人们已经提议或使用许多方法来帮助哺乳动物减少能量摄取(例如热量摄取),以达到控制体重的目的。这些方法包括使用作用于中枢神经系统来增加血清素含量的药剂,以及那些在胃肠道中起作用来减少营养物质的消化和/或吸收的药剂。这些方法存在的潜在副作用减弱了它们长期控制体重的效用。
一种不同的方法涉及将营养物质直接导入小肠末梢,力图减少伴随的食物摄取。这种方法使用天然物质,被认为通过营养物质同公认的受体在贯穿小肠内的相互作用来起作用,尤其是在小肠末梢(空肠、回肠),据信这种相互作用参与了导致进餐终止的天然机制。由于使用天然物质和机制,这就提供了减少副作用的潜在益处。动物和人类的报告资料是基于分别使用导管和鼻胃管直接将营养物质导入小肠。所报告的研究中许多都使用了类脂。例如,向小肠(空肠或回肠)中注射玉米油乳液,减少伴随正餐的食物摄取,这样总的热量摄取(正餐加上注射液)显著减少或直接减少。参见Welch等人的“Effect of Ileal and Intravenous Infusionsof Fat Emulsions on Feeding and Satiety in Human Volunteers”,Gastroenterology,第89卷,第1293-1297页(1985)和Welch等人的“Comparisons of the Effects on Satiety and Eating Behavior ofInfusion of Lipid into the Different Regions of the SmallIntestine”,Gut,第29卷,第306-311页(1988)。在个别几个研究中,三酰基甘油乳液静脉内给药未能减少总的热量摄取。参见Walls和Koopmans的“Effect of Intravenous Nutrient Infusions on FoodIntake in Rats”,Physiology&Behavior,第45卷,第1223-1226页(1989)。
已经报导了许多对动物进行的研究,其中向小肠中注射营养物质来减少食物摄取。Meyer等人已经进行了一系列研究,研究注射的营养物质对强制进行三小时给食的大白鼠总热量摄取的影响。他们发现,当注射入十二指肠或中肠(空肠)或注射入结肠时,长度大于10个碳原子的脂肪酸乳液、只对葡萄糖输送物具有亲和力的单体碳水化合物溶液以及氨基酸色氨酸和苯基丙氨酸的溶液抑制了总的热量摄取。这些研究者也证明,餐前的三酰基甘油未能抑制强制进行七小时给食的大白鼠的总热量摄取。参见Meyer等人的“Chemical Specificities and Intestinal Distributionsof Nutrient-Driven Satiety”,Am.Journal Physiology,第275卷,R1293-R1307(1998)。
不久前,Cox等人证明了向空肠注射纯亚油酸或油酸(0.2mL/hr进行七小时)会显著减少大白鼠每日的总热量摄取,而注射长链三酰基甘油(玉米油)没有这种效果。这些作者也证明,在20多天的给药中一直保持了热量摄取的减少,结果治疗过的动物和对照动物的体重显著不同。参见Cox等人的“Suppression of Food Intake,Body Weight,and BodyFat by Jejunal Fatty Acid Infusions”,Am.Journal Physiology,Regulatory Integratiye Comparative Physiology,第278卷,R604-R610(2000)。
最近,有人描述了设计用来在胃中释放这种脂肪酸的长链脂肪酸组合物。参见WO02/00042。
其他人描述了较短链组分如丙酸钠在食物形式如面包中的作用。例如,Liljeberg和Bjrck描述了诱发人类产生饱腹感是由于面包中含有丙酸钠从而延迟了胃排空速率所致。然而,他们发现丙酸钠对于大白鼠的胃排空没有效果。参见Liljeberg和Bjrck的“Delayed GastricEmptying Rate as a Potential Mechanism for Lowered GlycemiaAfter Eating Sourdough Bread:Studies in Humans and Rats UsingTest Products with Added Organic Acids or an Organic Salt”,Am.J.Clin.Nutr.,第64卷,第886-893页(1996)。至于其他报导的短链脂肪酸的有益效果,也可参见Todesco等人的“Propionate LowersBlood Glucose and Alters Lipid Metabolism in HealthySubjects”,Am.J.Clin.Nutr.,第54卷,第860-865页(1991);Wright等人的“Propionate Inhibits Hepatocyte Lipid Synthesis”,Society for Experimental Biology and Medicine,第195卷,第26-29页(1990);Berggren等人的“Influence of Orally and RectallyAdministered Propionate on Cholesterol and Glucose Metabolism inObese Rats”,British Journal of Nutrition,第76卷,第287-294页(1996);Cameron-Smith等人的“Effect of Propionate on In VivoCarbohydrate Metabolismin Streptozocin-Induced Diabetic Rats”Metabolism,第43卷,No.6,第728-734页(1994),Venter等人的“Effects of Dietary Propionate on Carbohydrate and LipidMetabolism in Healthy Volunteers”The American Journal ofGastroenterology,第85卷,No.5,第549-553页(1990),Farningham和Whyte的“The Role of Propionate and Acetate in the Control ofFood Intake in Sheep”第70卷,第37-46页(1993);Farningham等人的“Satiety Signals in Sheep:Involvement of CCK,Propionate,and Vagal CCK Binding Sites”,Physiology and Behavior,第54卷,第437-442页(1993)。
因此,人们通过诱发饱腹感和其他体重控制效果的各种给药途径,分别描述了某些短链和长链脂肪酸组合物的使用。很清楚,这种组合物的使用是新兴的并且具有独特的重要性,因此在这个领域推进它的研究将会是有益的。
本发明者出乎意料地发现,某些长链脂肪酸组分(LCFA)同某些短链脂肪酸组分(SCFA)的组合可以在体重控制领域有效提供真实的协同有益效果。具体地讲,这些组合比添加剂方式大大有效,这是本领域未预料到的。因此,本发明者通过提供本领域以前没有描述过的独特有效的组合物,发现了体重控制方法功效方面的一个重大进步。
发明概述
本发明涉及包含适于口服的包含短链和长链脂肪酸的组合物,其中所述组合物可用于控制体重。例如,可通过使用本发明组合物诱发饱腹感而有效地控制体重。具体地讲,本组合物包含:
(a)短链脂肪酸组分,所述短链脂肪酸组分选自乙酸、丙酸、丁酸、它们的酯、它们的盐以及它们的混合物;和
(b)长链脂肪酸组分,所述长链脂肪酸组分选自长链脂肪酸、长链脂肪酸的非甘油酯以及它们的混合物;
其中所述组合物适于哺乳动物口服。
本发明还涉及使用本组合物来控制体重的方法。
发明详述
本发明的公开内容引用了包括例如出版物和专利的多种文件。所有这些文献均引入本文以供参考。任何特定文献的引用都不可解释为是对其作为本发明的现有技术的认可。
除非另外指明,所有百分比和比例均以重量计。除非另外指明,所有百分比和比例的计算均基于总组合物。
本文引用的是包括本发明所用各种成分的组分的商品名。本发明者不旨在局限于某一商品名称的物质。可以使用以商品名引用的那些材料的等价物质(如以不同的名称或参考号从不同来源获得的那些)取代并应用于本发明的描述。
在本发明的说明书中公开了多种不同的实施方案或个别特征。对于本领域的普通技术人员显而易见的是,这些实施方案和特征的所有组合都是可能的,并可导致本发明的优选实施。
本发明的组合物可包含本发明所述任何要素、基本上由或由本发明所述任何要素组成。
虽然只举例说明和描述了本发明的多种实施方案和个别特征,在不背离本发明精神和范围的条件下,可以对其进行各种改变和修改。同样明显的是,这些实施方案和在上述公开文件中提出的特征的所有组合都是可能的,并可导致本发明的优选实施。
定义
本文所用术语“作为伴侣的动物”是指家畜。优选地,“作为伴侣的动物”是指家犬、猫、兔、雪貂、马、母牛等。最优选地,“作为伴侣的动物”是指家犬或猫。
本文所用术语“安全有效”是指当以本发明的方式使用时,能够有效地控制哺乳动物(优选人类或作为伴侣的动物)的体重而无不当负作用(例如毒性、刺激或变应性反应)的,与合理的效/险比相当。
本发明的组合物
本发明的组合物可用于多种目的,尤其是控制体重。具体地讲,不受理论的限制,据信本组合物可用于诱发饱腹感反应,及其他对于调控体重重要的生物反应。本发明者出乎意料地发现,某些长链脂肪酸组分(LCFA)同某些短链脂肪酸组分(SCFA)的组合可以在体重控制领域有效提供真实的协同有益效果,这是本领域未预料到的。
本组合物包括包含以下组分的那些:
(a)短链脂肪酸组分(SCFA),所述短链脂肪酸组分选自乙酸、丙酸、丁酸、它们的酯、它们的盐以及它们的混合物;和
(b)长链脂肪酸组分(LCFA),所述长链脂肪酸组分选自长链脂肪酸、长链脂肪酸的非甘油酯以及它们的混合物;
其中所述组合物适于哺乳动物口服。
本发明者发现,SCFA同LCFA的组合(SCFA和LCFA如本文所定义)产生了未预料到的真实协同反应,据发现这是调控体重领域的一个重大进步。具体地讲,发明者发现SCFA同LCFA的组合(SCFA和LCFA还如本文所特别定义)产生了大大超出所预料的真实协同反应。例如,发明者发现其中给不同的剂量组分别给服非优化含量的SCFA和LCFA,发现两个剂量组的热量摄取减小都是非优化的。相反,例如,当在同一个剂量组内同时给服SCFA和LCFA,各自使用同样的非优化含量时,就可获得有效的、协同的热量摄取减少。从而,发明者发现各组分的一种重要组合,尤其对于有效地控制体重组合物的进步有用。
本组合物的多种组分进一步描述如下:
短链脂肪酸组分:
所述短链脂肪酸组分(本文通常称为“SCFA”)选自乙酸、丙酸、丁酸、它们的酯、它们的盐以及它们的混合物。这些SCFA是本领域通常所熟悉的。
其中SCFA是乙酸、丙酸或丁酸,可优选使用丙酸。SCFA也优选选自丙酸、丙酸盐、丙酸酯以及它们的混合物。
在乙酸、丙酸、丁酸、它们的酯、它们的盐以及它们的混合物之中,乙酸、丙酸、或丁酸的盐(“其盐”)是最优选的。乙酸、丙酸、或丁酸的盐可以是这种酸的任何安全有效的盐。举例说明,某种优选的盐可包括钙盐、钠盐、镁盐和钾盐。在这些盐中,乙酸、丙酸、或丁酸的钙盐和钠盐是尤其优选的,而钙盐是最优选的。
例如、优选的丙酸盐包括丙酸钙、丙酸钠、丙酸镁、丙酸钾以及它们的混合物。在这些盐中,丙酸钙和丙酸钠是尤其优选的,而丙酸钙是最优选之一。
作为另外的例子,可使用氨基酸盐。例如,可使用乙酸、丙酸、或丁酸的肉毒碱或赖氨酸盐。普通技术人员将认识到多种其他氨基酸也同样适用。
作为丙酸盐在本文提供控制体重效果的附加有益效果,某些盐也可以有益地提供营养的或其他有益效果。例如,使用丙酸钙可附加地提供钙源,已知钙源对于多种健康有益效果是有用的。
作为乙酸、丙酸或丁酸的酯的实施例,可以使用这种酸的任何安全有效的酯。例如,当SCFA是丙酸酯时,所述组分描述如下:
其中X是酯链或丙酸酯。
作为实施例,所选酸的酯链可以是碳原子直链或支链,该酯链可在哺乳动物消化酶(优选人类消化酶)存在下水解,并且典型地包含约8个或更少的碳原子。此酯链更优选地含有1至约5个碳原子,也可以是直链(例如正丙基)或支链(例如异丙基)。高度优选的酯链包括形成甲基酯(即X是-CH3)、乙基酯、正丙基酯、异丙基酯、正丁基酯、异丁基酯以及它们的混合物的那些。举例说明,丙酸甲酯、丙酸乙酯、丙酸正丙酯、丙酸异丙酯、丙酸正丁酯、丙酸异丁酯是本文可用丙酸酯的实施例。也可选择乙酸或丁酸的这些酯。
包含在给定组合物中的SCFA含量,将典型地由所选用的特定剂型决定,尤其是当这种含量用相对于组合物中存在的所有组分的重量百分比表示时。例如,如本文进一步所描述,尤其优选的剂型包括药片、胶囊、其他浓缩的口服可使用形式、食品、饮料等。典型地,相对于(例如)饮料,药片或胶囊可包含按组合物重量百分比计更高含量的SCFA。
例如,本发明组合物的某些剂型可任选地包含按组合物重量计约0.0001%至约50%的SCFA。在另一个实施方案中,组合物可包含按组合物重量计约0.001%至约8%、更优选约0.01%至约4%的SCFA。在另一个实施方案中,组合物可包含按组合物重量计约0.01%至约2%的SCFA。
例如,本组合物的药片或胶囊形式(或其他类似形式)可以任选地包含按组合物重量计约1%至约50%的SCFA。作为另一个实施方案,本组合物的乳液形式可任选地包含按组合物重量计约0.1%至约10%、更优选约0.5%至约5%的SCFA。另外,食品或饮料形式常包含按组合物重量计约0.0001%至约8%的SCFA。
可供选择地或另外,本发明组合物的单次剂量可任选地包含约0.01克至约10克、更优选约0.04克至约1克的SCFA,所有量都是接受组合物给药的个体每公斤体重所需量。本文所用的单次剂量是指在一给定时间典型地消耗组合物的量。
长链脂肪酸组分
所述长链脂肪酸组分(本文通常称为“LCFA”)选自长链脂肪酸、长链脂肪酸的非甘油酯以及它们的混合物。如本文所用,所述LCFA包含一个脂肪酸链或其中的脂肪酸物质是脂肪酸酯时,包含一个脂肪酸链和一个酯链。这样,当LCFA是脂肪酸时,这种物质描述如下:
R-COOH
其中“R”是含有约10至约24个碳原子的饱和或不饱和链的脂肪酸链,且其中“COOH”是羧酸部分。更优选地,“R”是含有约12至约24个碳原子、最优选约16至约18个碳原子的饱和或不饱和链。还优选地,脂肪酸链含有0至约3个双键。最优选地,脂肪酸链是不饱和的,尤其是含有一个或两个双键。
当脂肪酸物质是脂肪酸的非甘油酯(即“它们的非甘油酯”)时,物质描述如下:
R-COOR′
其中R是上文定义的脂肪酸链,且R′是酯链,羧化物部分“COO”将两者连接在一起。酯链是碳原子的直链或支链,此链在哺乳动物消化酶(优选人类消化酶)存在下水解,典型地含有约8个或更少的碳原子。此酯链更优选地含有1至约5个碳原子,也可以是直链(如正丙基)或支链(如异丙基)。高度优选的酯链包括形成甲基酯(即R′是-CH3)、乙基酯、正丙基酯、异丙基酯、正丁基酯、异丁基酯以及它们的混合物的那些。那些形成乙基酯的酯链是尤其优选的。
在本发明的一个优选实施方案中,LCFA选自月桂酸、月桂烯酸、肉豆蔻酸、肉豆蔻脑酸、十五烷酸、棕榈酸、棕榈油酸、十七烷酸、硬脂酸、二羟基硬脂酸、油酸、蓖麻油酸、反油酸、亚油酸、α-亚麻酸、二高γ-亚麻酸、桐酸、十八碳三烯-4-酮酸、花生四烯酸、花生酸、二十碳酸烯酸、二十碳五烯酸、二十二烷酸、芥酸、二十二碳六烯酸、二十四烷酸、它们的非甘油酯以及它们的混合物。
在本发明的一个尤其优选实施方案中,脂肪酸物质选自月桂酸、月桂烯酸、肉豆蔻酸、肉豆蔻脑酸、十五烷酸、棕榈酸、棕榈油酸、十七烷酸、硬脂酸、二羟基硬脂酸、油酸、蓖麻油酸、反油酸、亚油酸、α-亚麻酸、二高γ-亚麻酸、桐酸、十八碳三烯4酮酸、花生四烯酸、花生酸、二十碳酸烯酸、二十碳五烯酸、二十二烷酸、芥酸、二十四烷酸、它们的非甘油酯以及它们的混合物。另外,尤其优选的脂肪酸物质包括油酸、亚油酸、它们的酯以及它们的混合物。这个实施方案优选的非甘油酯包括油酸乙酯、亚油酸乙酯以及它们的混合物。作为实施例,油酸乙酯可得自多种途径,包括Victorian Chemical Co.,Richmond,VictoriaAustralia、Penta Manufacturing Co.,Livingston,NJ和Croda,Inc.,Parsippany,NJ。
类似于SCFA,给定组合物中LCFA的含量将典型地由所选用的特定剂型决定,尤其是其中这种含量用相对组合物中存在的所有组分的重量百分比表示时。例如,如本文更进一步所描述,尤其优选的剂型包括药片、胶囊、其他浓缩的口服可使用形式、食品、饮料等。典型地,相对于(例如)饮料,药片或胶囊可包含按组合物重量百分比计更高含量的LCFA。
例如,本组合物的某些剂型可任选地包含按组合物重量计约0.0001%至约90%的LCFA。在另一个实施方案中,组合物可包含按组合物重量计约0.001%至约10%、更优选约0.01%至约5%的LCFA。在再一个实施方案中,组合物可包含按组合物重量计约0.01%至约3%的LCFA。
例如,本发明组合物的药片或胶囊形式(或其他类似形式)可以任选地包含按组合物重量计约1%至约90%的LCFA。作为又一个实施例,本组合物的乳液形式可任选地包含按组合物重量计约10%至约40%的LCFA、更优选约15%至约30%的LCFA。另外,食品或饮料形式常包含按组合物重量计约0.0001%至约10%的LCFA。
可供选择地或另外,本发明组合物的单次剂量可任选地包含约0.001克至约10克、更优选约0.004克至约1克的LCFA,所有量都是接受组合物给药的个体每公斤体重所需量。本文所用的单次剂量是指在一给定时间典型地消耗组合物的量。
LCFA对SCFA的任选比例
在本发明任选的实施方案中,发明者发现本文所述组合物控制体重的功效,可通过调节LCFA对SCFA的比例(按LCFA对SCFA的重量计)而达到尤其最优化。例如,在本文的一个任选实施方案中,LCFA对SCFA的比率按重量计是约40∶1或更小,也可选约20∶1或更小,也可选约10∶1或更小,也可选约5∶1或更小。在本文尤其有利的实施方案中,LCFA对于SCFA的比率按重量计为约10∶1或更小。
本组合物的任选组分和用法
本文所述组合物可用于各种各样的最终组合物。所述组合物可用于例如药物组合物、非处方组合物、饮食增补剂、药用食品、食品和饮料,以及许多其他组合物。
本发明的组合物可包含附加任选组分以便例如提高它们的性能或另外使此组合物更适于作为工业产品或消费品使用。下面给出了任选组分的非限制性实施例:
水
本发明的组合物可包括水,例如其中组合物是食品或饮料组合物时。本文所用术语“水”包括组合物中存在的全部水,包括来自例如乳蛋白质、果汁或蔬菜汁的水以及任何添加的水。其中使用水时,可选包括水的含量按组合物重量计为例如约10%至约99.999%、更优选约5%至约99%、还更优选至少约50%、甚至更优选至少约70%、最优选约70%至约99%。即饮型饮料组合物按组合物的重量计,典型地包含至少约70%水、更优选约75%至约99%的水。
碳水化合物
本发明组合物可包含多种碳水化合物中的任何一种。这些碳水化合物常可包含在食品或饮料剂型的组合物中。例如,某些甜味剂是碳水化合物。
甜味剂
本发明组合物可任选包含有效量的一种或多种甜味剂,这些甜味剂包括碳水化合物甜味剂和天然或人造无/低卡路里甜味剂。用于本发明组合物的甜味剂的量典型地取决于具体使用的甜味剂和所需的甜度。对于无/低卡路里甜味剂,该量依具体甜味剂的甜度而变化。
使用任何碳水化合物甜味剂、优选单糖和/或二糖,可使本发明的组合物变甜。变甜的组合物,尤其是饮料,将典型地包含按组合物重量计约0.1%至约40%、更优选约0.1%至约20%、最优选约6%至约14%的甜味剂。这些甜味剂可以固体或液体(比如糖浆)形式掺入组合物。
用于本发明组合物优选的食糖甜味剂是蔗糖、果糖、葡萄糖以及它们的混合物。果糖可以液体果糖、高果糖含量玉米糖浆、干果糖或果糖糖浆的形式获得或提供。其他天然存在的甜味剂或它们的纯化提取物,比如甘草素、蛋白质甜味剂非洲甜果素、公开于例如美国专利5,433,965中的罗汉果汁等,也可用于本发明组合物。
合适的无/低卡路里甜味剂包括,例如,糖精、环磺酸盐、L-天冬氨酰基-L-苯基丙氨酸较低烷基酯甜味剂(例如天冬甜素);公开于Brennan等人的美国专利4,411,925的L-天冬氨酰基-D-丙氨酸酰胺;公开于美国专利4,399,163的L-天冬氨酰基-D-丝氨酸酰胺;公开于美国专利4,338,346的L-天冬氨酰基-L-1-羟基甲基链烷酰胺甜味剂;公开于美国专利4,423,029的L-天冬氨酰基-1-羟基乙基链烷酰胺甜味剂;公开于欧洲专利申请168,112的L-天冬氨酰基-D-苯基甘氨酸酯和酰胺甜味剂;公开于1999年6月24日公布的WO 99/30576的N-[N-3,3-二甲基丁基)-L-α-天冬氨酰基]-L-苯基丙氨酸1-甲基酯甜味剂;alltame、非洲甜果素;二氢查尔酮;环磺酸盐;蛇菊苷;甘草素、合成烷氧基芳族基化合物例如甘素和P-4000;三氯蔗糖;suosan;奇异果素;应乐果甜蛋白;山梨醇、木糖醇;甜蛋白;环己基氨基磺酸盐;取代的咪唑啉;合成氨基磺酸例如丁磺氨、丁磺氨-K和n-取代的氨基磺酸;肟例如perilartine;肽例如天冬氨酰基丙二酸酯和succanilic酸;二肽;氨基酸基的甜味剂例如同偕-二氨基烷、间-氨基苯甲酸、L-氨基二羧酸烷烃、及某些α-氨基二羧酸的酰胺和同偕-二胺;3-羟基-4-烷氧基苯基脂肪族羧酸酯或杂环芳族羧酸酯;赤藓醇以及它们的混合物。
着色剂
本发明组合物可使用一种或多种着色剂。例如,可使用天然或人造着色剂。
优选使用FD&C染料(例如黄#5、蓝#2、红#40)和/或FD&C色淀。通过将色淀加入其他粉末成分,所有颗粒,尤其是有色的铁化合物,被完全均匀地着色并得到一种均匀着色的组合物。本发明可使用的优选色淀染料是FDA核准的色淀,如色淀红#40、黄#6、蓝#1,等等。此外,可使用FD&C染料或FD&C色淀染料与其他常用食品和食品着色剂组合形成的混合物。
可使用其他着色剂,例如天然着色剂。
所用着色剂的量可以改变,这取决于所用的试剂和最终组合物期望的色度。通常,如果使用,所用着色剂按组合物重量计,典型地以约0.0001%至约0.5%、优选约0.001%至约0.1%、最优选约0.004%至约0.1%的含量存在。
风味剂
本发明组合物可任选包含一种或多种风味剂。优选地,这些风味剂包含在饮料组合物中,且典型地选自果汁、水果香料、植物风味剂以及它们的混合物。当本发明的饮料中包含果汁时,其可包含约0.1%至约99%、优选约1%至约50%、更优选约2%至约30%、最优选约5%至约20%的果汁。如本文所测,果汁的重量百分比基于原汁2°至16°Brix糖度的果汁。所述果汁可以果泥、粉末或以原汁或浓缩汁掺入饮料中。尤其优选的是所述果汁以浓缩物掺入,所述浓缩物含有约20°至约80°Brix糖度的固体成分(主要是糖固体)。
果汁可以是任何柑橘类汁、非柑橘类汁或它们的混合物,这些是众所周知用于稀释果汁饮料的。汁可得自例如苹果、越橘、梨、桃、李子、杏、蜜桃、葡萄、樱桃、醋栗、悬钩子、醋栗、接骨木果、黑莓、蓝莓、草莓、柠檬、酸橙、中国柑桔、橙、柚子、cupuacu、马铃薯、番茄、莴苣、芹菜、菠菜、卷心菜、豆瓣菜、蒲公英、大黄、胡萝卜、甜菜、黄瓜、菠萝、椰子、石榴、猕猴桃、芒果、番木瓜果、香蕉、西瓜、西番莲果、橘子和甜瓜。优选的汁得自于苹果、梨、柠檬、甜橙、中国柑桔、柚子、越橘、橙、草莓、橘子、葡萄、猕猴桃、菠萝、西番莲果、芒果、番石榴、悬钩子和樱桃。柑橘汁、优选柚子、橙、柠檬、酸橙和中国柑桔汁,以及得自于芒果、苹果、西番莲果和番石榴的汁,及这些汁的混合物是最优选的。
也可以使用水果香料。如上文关于风味剂乳液的描述,水果香料可得自天然资源如精油和提取物,或可由合成制备。水果香料可通过加工尤其是浓缩得自于水果。
也可使用植物风味剂。本文所用术语“植物风味剂”是指得自于植物除了水果部分的风味剂,即得自于坚果、树皮、树根和/或树叶。术语“植物风味剂”还包括模拟得自于天然资源的风味剂所制的合成制备风味剂。植物风味剂可得自于天然资源比如精油和提取物,或可由合成制备。合适的植物风味剂包括茶、咖啡、巧克力、香草、肉豆蔻果核、可乐果、金盏花、菊花、春黄菊、姜、缬草、育亨宾树、蛇麻子、圣草、人参、越桔、稻、红酒、芒果、牡丹花、柠檬香脂、核果瘤、橡树薄片、熏衣草、胡桃、龙胆、罗汉果、肉桂、当归、芦荟、龙牙草、蓍草以及它们的混合物。尤其优选的风味剂包括巧克力或香草。
蛋白质组分
本组合物可任选地包含一种蛋白质组分,例如,动物或植物蛋白质。
这种蛋白质的一个非限制性实施例包括乳蛋白质。乳蛋白质包含选自乳清、酪蛋白以及它们的混合物的蛋白质。乳蛋白质可以是蛋白质自身,例如酪蛋白钠或钙,或可以是包含蛋白质和一种或多种其他物质的组分。例如,多种乳蛋白质为本领域的普通技术人员所熟知,并且可以用来作为本文的蛋白质组分。
当乳蛋白质是作为蛋白质自身被输送时,酪蛋白是本文优选使用的蛋白质。然而,也可包含乳清或酪蛋白和乳清的混合物。酪蛋白可作为多种形式使用,这些形式包括例如酪蛋白钠或酪蛋白钙。本文优选使用酪蛋白钠和酪蛋白钙的混合物。
乳蛋白质包括哺乳动物或植物乳,例如全脂奶、脱脂奶、炼乳、干奶粉、乳蛋白浓缩物、分离乳蛋白、水解乳蛋白以及它们的混合物。举例说明,通过乳超滤或其他方法制备乳蛋白浓缩物,这样乳糖或盐含量降低,从而提高了蛋白质含量。在奶粉或炼乳中,水被除去,但乳的所有其他组分都充分保留。所有形式的乳蛋白可包含例如原乳蛋白、水解乳蛋白或它们的任何组合。
当使用时,本组合物的蛋白质含量将取决于多种因素,这些因素包括,例如,蛋白质是蛋白质自身还是作为组分的组合(例如全脂奶)输送,最终组合物所需蛋白质的量,等等。在一个任选的实施方案中,组合物包含按组合物重量计至少约0.5%的蛋白质。在另一个实施方案中,组合物包含按组合物重量计约0.5%至约10%的蛋白质、甚至更优选约0.5%至约8%的蛋白质,且最优选约0.5%至约5%的蛋白质。
营养物质
本发明的组合物可用一种或多种营养物质,本发明定义为一种或多种维生素和/或矿物质来强化。
作为实施例,当给定矿物质存在于本组合物时,该组合物任选包含至少约1%、优选至少约5%、更优选约10%至约200%、甚至更优选约40%至约150%、最优选约60%至约125%的该矿物质的USRDI。在另一个实施例中,当给定维生素存在于本组合物时,该组合物任选地包含至少约1%、优选至少约5%、更优选约10%至约200%、甚至更优选约20%至约150%、最优选约25%至约120%的该维生素的USRDI。维生素和矿物质的美国推荐日摄取量(USRDI)定义并描述于Recommended Daily DietaryAllowance-Food and Nutrition Board,National Academy ofSciences-National Research Council。
维生素的非限制性实施例包括维生素A、B1、B2、B3、B6和B12,叶酸,泛酸,叶酸,维生素C、D、和E。
矿物质的非限制性实施例包括钙、碘、铬、镁、锰、钼、硒、磷、镁、锌、碘、铁和铜。作为实施例,可任选使用适于包含在可食用组合物中的这些矿物的任何可溶性盐。
纤维
在本发明的一个尤其优选实施方案中,所述组合物包含一种或多种纤维。纤维是本领域所熟知的,且包括对哺乳动物酶的消化作用有抵抗力的络合碳水化合物,例如存在于植物细胞壁和海藻中的碳水化合物,和那些由微生物发酵产生的碳水化合物。这些络合碳水化合物的实施例是燕麦纤维、麸、纤维素、半纤维素、果胶、树胶和胶浆(例如瓜耳树胶和阿拉伯树胶)、海藻提取物、角叉菜胶和生物合成树胶。纤维素纤维的来源包括蔬菜、水果、种子、谷类食品和人造纤维(例如由细菌合成所得)。也可使用市售纤维,如纯化植物纤维素或纤维素粉。天然纤维包括来自整个柑橘皮、柑橘白色内皮、糖用甜菜、柑橘果肉和小泡固体、苹果、杏和西瓜皮的纤维。
用于本文的其他优选纤维包括阿拉伯半乳聚糖。优选的市售阿拉伯半乳聚糖来源的非限制性实施例包括LAREX UF、LARACARE A200、IMMUNENHANCER(CAS No.9036-66-2)、CLEARTRAC、FIBERAID和AC-9,全部购自(例如)St.Paul,Minnesota的Larex,Inc.。
这些可食用纤维可以是未加工形式或纯化形式。所用的食用纤维可以是单一类型(例如纤维素)、复合食用纤维(例如包含纤维素和果胶的柑橘白色内皮纤维)或某些纤维组合(例如纤维素和树胶)。可用本领域熟知的方法加工纤维。
其中使用纤维时,本发明组合物所需的纤维总含量,典型地为按组合物重量计约0.001%至约15%、优选约0.01%至约10%、更优选约0.1%至约10%、最优选约1%至约9%。纤维的总量包括任何添加的纤维以及本发明任何其他组分中固有的任何可溶食用纤维。
PH值
本发明的组合物可具有多种pH水平。其中当组合物是饮料组合物时,给定组合物的pH值尤为重要。例如,组合物可以本质上是酸性的(例如pH值为约3至约5)或碱性较强的。本发明优选组合物的pH值范围为约6至约8、更优选约6.3至约7.4。
可使用有机以及无机食用酸来降低饮料组合物的pH值。该酸可以其未解离的形式或可选择地以其各自盐的形式存在,例如磷酸氢钾或磷酸氢钠、磷酸二氢钾或磷酸二氢钠盐。优选的酸为可食用有机酸,包括柠檬酸、苹果酸、反丁烯二酸、己二酸、磷酸、葡萄糖酸、酒石酸、抗坏血酸、乙酸、磷酸,或它们的混合物。最优选的酸是柠檬酸和苹果酸。葡糖酸δ内酯(GDL)也是用于本文的优选酸,尤其其中需要降低pH值,而又不在最终组合物中引入过多酸性味或酸味时使用。
对那些本质上碱性较强的组合物可使用多种碱。例如,本文可使用氢氧化钠或氢氧化钾。
本发明的方法
本发明的方法包括让哺乳动物(优选人或作为伴侣的动物)口服本发明的组合物以控制体重。本文所用术语“控制体重”是指这样的效果,这种效果选自诱发饱腹感(例如控制或遏制食欲)、达到能量(例如热量)摄取减少、达到体重减轻、抑制体重增加、保持体重以及它们的组合。在一个实施方案中,所述效果选自诱发饱腹感、达到能量摄取减少以及它们的组合。在另一个实施方案中,所述效果是诱发饱腹感。
本发明所用术语“口服”、“口服给药”等,对哺乳动物而言是指哺乳动物咽下或在指导下咽下(优选地,出于控制体重的目的)一种或多种本发明组合物。其中当哺乳动物在指导下咽下一种或多种所述组合物时,该指导可能是那种指示和/或告知用户,使用该组合物可以和/或将提供一种或多种一般健康和/或一般生理学的有益效果的指导,这种有益效果包括但不限于控制体重、恢复精力和获得营养。例如,该指导可以是口头指导(例如,通过来自如下方面的口头说明:例如医师、保健专家、销售人员或组织、和/或无线电或电视媒体(即广告))或书面指导(例如,通过来自如下方面的书面指导:如医师或其他保健专家(例如手稿)、销售人员或组织(如通过例如营销手册、小册子或其它传播信息的附件)、书面媒体(例如因特网、电子邮件或其它计算机相关媒体)和/或与组合物有关的包装(例如,包含组合物的包装上的标签))。如本发明所用,“书面的”是指通过文字、图片、符号和/或其它可视的描述符。这样的指导不需要使用本文所用的实际文字,例如“控制体重”、“饱腹感”、“能量摄取”、“哺乳动物”,等等,而宁愿使用合理传达相同或类似意思的文字、图片、符号等被考虑在本发明的范围内。
所述方法涉及本发明组合物的用法。可以根据治疗的必需或需要采取多种给药频率,例如本文所述的组合物每日或每周给药。尤其优选每日给药,包括例如组合物每日一次、每日两次和/或每日三次给药。尤其优选每日一次给药。
给药可伴随正餐的摄取、可在两餐之间服用或可作为正餐代替物。例如,本发明的组合物可作为正常饮食需要的补充物被摄取。本领域的普通技术人员将意识到,组合物的最优化取决于给药的时间或特性。例如,其中给药作为正餐代替物时,将组合物配制为食品(例如正餐替代棒)和饮料会有利。作为另一个实施例,其中当给药伴随正餐或在两餐之间时,将组合物配制成药片、胶囊或咀嚼片将是有利的。
组合物可作为多种形式中的任何一种进行给药,例如,作为食品(例如棒)、饮料、药片、胶囊、咀嚼片、乳液及其他口服形式。其中形式是药片、胶囊等时,制备合适剂型的非限制性技术描述于下列文献中:Banker和Rhodes所编的“Modern Pharmaceutics”,第9章和第10章(1979);Lieberman等人的Pharmaceutical Dosage Forms:Tablets(1981);和Ansel的Introduction to Pharmaceutical DosageForms,第2版(1976)。
在本发明的一个任选实施方案中,组合物包含肠递送体系、优选小肠内肠递送体系。举例说明,为了向小肠内递送SCFA和/或LCFA,可以将SCFA和/或LCFA同pH值为约5.5或更大的组分结合,这样SCFA和/或LCFA未被吸收地绕过胃,且被特别地输送到小肠区。其中LCFA或SCFA是游离酸(例如,不是乙酸、丙酸或丁酸的酯)时会尤其有利。肠递送体系是通常所熟知的。
剂量应易于例如根据给服该组合物的哺乳动物或可能那个特殊哺乳动物的需要而改变。典型地,将递送安全有效剂量的组合物。本文已经描述了SCFA和LCFA的优选含量。而且,本文也已经描述了SCFA对LCFA的优选比率。应该理解这些上文描述的剂量范围仅用于示例的目的,可根据多种因素调节给药。例如,给药组合物具体的剂量和治疗的持续时间是相互依赖的。剂量和治疗方案还取决于如下因素:所用的具体化合物、治疗的适应症、化合物的功效、哺乳动物的个体特质(比如,例如哺乳动物的体重、年龄、性别和体格状况)、对治疗方案的顺应性。
实施例
下面是使用常规方法制备的本组合物的非限制性实施例。给出下述实施例是为了举例说明本发明,而不是以任何方式限制其范围。
实施例1
制备以显示的量含有如下组分的柑橘味饮料组合物:
组分 | 重量百分比 |
柠檬酸钠 | 0.06 |
果胶 | 0.3 |
阿拉伯树胶 | 1.5 |
酪蛋白钠 | 0.55 |
酪蛋白钙 | 1.18 |
糖 | 1.02 |
柠檬酸 | 0.28 |
丁磺氨K | 0.01 |
三氯蔗糖,25%溶液 | 0.04 |
丙酸钙 | 0.03 |
油酸乙酯 | 0.61 |
乳酸钙 | 0.04 |
赤藓醇 | 1.97 |
调味剂(包括芒果、桃和香草风味剂) | 1.55 |
水 | 足量 |
实施例2
制备以显示的量含有如下组分的柑橘味饮料组合物:
组分 | 重量百分比 |
柠檬酸钠 | 0.06 |
果胶 | 0.3 |
阿拉伯树胶 | 1.5 |
酪蛋白钠 | 0.55 |
酪蛋白钙 | 1.18 |
糖 | 1 |
柠檬酸 | 0.28 |
丁磺氨K | 0.01 |
三氯蔗糖,25%溶液 | 0.04 |
丙酸钙 | 0.03 |
油酸乙酯 | 0.6 |
乳化剂(乳酰化硬脂酸盐,例如商购自AmericanIngredients,Inc.的EMPLEX K) | 0.05 |
乳酸钙 | 0.04 |
赤藓醇 | 1.97 |
调味剂(包括芒果、桃和香草风味剂) | 1.55 |
水 | 足量 |
实施例3
制备以显示的量含有如下组分的柑橘味饮料组合物:
组分 | 重量百分比 |
柠檬酸钠 | 0.06 |
果胶 | 0.6 |
阿拉伯树胶 | 1.5 |
酪蛋白钠 | 0.55 |
酪蛋白钙 | 1.18 |
糖 | 1.02 |
柠檬酸 | 0.28 |
丁磺氨K | 0.01 |
三氯蔗糖,25%溶液 | 0.04 |
丙酸钙 | 0.03 |
油酸乙酯 | 0.61 |
乳酸钙 | 0.04 |
赤藓醇 | 1.97 |
调味剂(包括芒果、桃和香草风味剂) | 1.55 |
水 | 足量 |
实施例4
制备以显示的量含有如下组分的柑橘味饮料组合物:
组分 | 重量百分比 |
柠檬酸钠 | 0.06 |
果胶 | 0.3 |
阿拉伯树胶 | 1.5 |
酪蛋白钠 | 1 |
酪蛋白钙 | 2.3 |
糖 | 1.02 |
柠檬酸 | 0.28 |
丁磺氨K | 0.01 |
三氯蔗糖,25%溶液 | 0.04 |
丙酸钙 | 0.03 |
油酸乙酯 | 0.61 |
乳酸钙 | 0.04 |
赤藓醇 | 1.97 |
调味剂(包括芒果、桃和香草风味剂) | 1.55 |
水 | 足量 |
实施例5
制备以显示的量含有如下组分的柑橘味饮料组合物:
组分 | 重量百分比 |
柠檬酸钠 | 0.06 |
果胶 | 0.6 |
阿拉伯树胶 | 1.5 |
酪蛋白钠 | 1 |
酪蛋白钙 | 1.75 |
糖 | 1.02 |
柠檬酸 | 0.28 |
丁磺氨K | 0.006 |
三氯蔗糖,25%溶液 | 0.04 |
丙酸钙 | 0.03 |
油酸盐乙酯 | 0.61 |
乳酸钙 | 0.04 |
赤藓醇 | 1.97 |
调味剂(包括芒果、桃和香草风味剂) | 1.55 |
水 | 足量 |
实施例6
据以下方法制备如实施例1-5中任何一个所述的组合物,在约20℃的基本恒定温度下进行。可供选择地,通过常规方法或其他方法来制备组合物。
准备一个Likwifier和混匀缸,放置好Likwifier,使得它同混匀缸进行循环运行。在Likwifier中加入水。作为形成第一混合物的一部分,在高剪切约4分钟(取决于批量大小)的条件下将柠檬酸钠、果胶和阿拉伯树胶依次加入Likwifier。为了最终形成第一混合物,在高剪切约4分钟的条件下将酪蛋白钠、酪蛋白钙和糖依次加入Likwifier,由此酪蛋白盐变成了水合物。为了形成第二混合物,在高剪切条件下约3至约30分钟时间内,取决于批量大小,将柠檬酸慢慢加入第一混合物。在高剪切约4分钟的条件下将丁磺氨K和三氯蔗糖溶液加入第二混合物。停止同混匀缸的循环。形成乳酸钙、丙酸钙和水的预混物,并在低剪切条件下将其加入混匀缸中的所得混合物中。然后在低剪切条件下将油酸乙酯(脂肪酸物质)加入所得混合物中。然后在低剪切条件下加入余下的组分。可任选在约34.47MPa压力下均化组合物,在超高温(UHT)条件下灭菌,在24.13MPa压力下均化,并无菌包装。
实施例7
制备以近似显示的量含有如下组分的香草味饮料组合物:
组分 | 重量百分比 |
角叉菜胶(商购自FMC Biopolymer Food&SpecialtyBusiness,Philadelphia,PA) | 0.04 |
纤维素树胶(商购自FMC BiopolymerFood&Specialty Business,Philadelphia,PA) | 0.52 |
阿拉伯树胶(商购自TIC Gums,Inc.,Belcamp,MD) | 0.41 |
营养物质 | 0.42 |
丙酸钙 | 0.03 |
大豆卵磷脂(商购自Central Soya,Fort Wayne,IN) | 0.03 |
油酸乙酯(购自Victorian Chemical Co.,Richmond,Victoria Austrailia) | 1.08 |
酪蛋白钠 | 0.3 |
乳蛋白质浓缩物(80%乳蛋白质)(商购自New ZealandMilk Products,Lemoyne,PA) | 3 |
糖 | 4 |
三氯蔗糖液体浓缩物(商购自McNeil Specialty,McIntosh,AL) | 0.03 |
调味剂,包括香草风味剂 | 0.75 |
水 | 足量 |
实施例8
制备以近似显示的量含有如下组分的11流体盎司巧克力味饮料组合物:
组分 | 重量百分比 |
氢氧化钠 | 0.03 |
角叉菜胶(商购自FMC Biopolymer Food&SpecialtyBusiness,Philadelphia,PA) | 0.05 |
纤维素树胶(商购自FMC BiopolymerFood&Specialty Business,Philadelphia,PA) | 0.44 |
阿拉伯树胶(商购自TIC Gums,Inc.,Belcamp,MD) | 0.45 |
淀粉(商购自National Starch&Chemical,Bridgewater,NJ) | 1.5 |
营养物质 | 0.48 |
丙酸钙 | 0.2 |
乳化剂 | 0.04 |
油酸乙酯(商购自Victorian Chemical Co.,Richmond,Victoria Austrailia) | 1.18 |
酪蛋白钠 | 0.33 |
乳蛋白质浓缩物(80%乳蛋白质)(商购自New ZealandMilk Products,Lemoyne,PA) | 3.23 |
糖 | 4 |
麦芽糖糊精 | 2 |
三氯蔗糖液体浓缩物(商购自McNeil Specialty,McIntosh,AL) | 0.06 |
调味剂,包括可可粉 | 2.75 |
水 | 足量 |
实施例9
制备以近似显示的量含有如下组分的11流体盎司巧克力味饮料组合物:
组分 | 重量百分比 |
聚磷酸钠 | 0.01 |
氢氧化钠 | 0.03 |
角叉菜胶(商购自FMC Biopolymer Food&SpecialtyBusiness,Philadelphia,PA) | 0.1 |
纤维素树胶(商购自FMC BiopolymerFood&Specialty Business,Philadelphia,PA) | 0.44 |
阿拉伯树胶(商购自TIC Gums,Inc.,Belcamp,MD) | 2.17 |
营养物质,包括丙酸钙 | 0.74 |
乳化剂 | 0.04 |
油酸乙酯(商购自Victorian Chemical Co.,Richmond,Victoria Austrailia) | 1.18 |
调味剂,包括可可粉 | 1.75 |
硅氧烷乳液 | 0.002 |
酪蛋白钠 | 0.33 |
乳蛋白质浓缩物(80%乳蛋白质)(商购自New ZealandMilk Products,Lemoyne,PA) | 4.7 |
精制糖 | 4 |
麦芽糖糊精 | 3 |
三氯蔗糖液体浓缩物(商购自McNeil Specialty,McIntosh,AL) | 0.06 |
水 | 足量 |
实施例10
制备以近似显示的量含有如下组分的11流体盎司巧克力味饮料组合物:
组分 | 重量百分比 |
角叉菜胶(商购自FMC Biopolymer Food&SpecialtyBusiness,Philadelphia,PA) | 0.06 |
纤维素树胶(商购自FMC BiopolymerFood&Specialty Business,Philadelphia,PA) | 0.49 |
阿拉伯树胶(商购自TIC Gums,Inc.,Belcamp,MD) | 0.45 |
营养物质,包括丙酸钙 | 0.65 |
乳化剂 | 0.04 |
油酸乙酯(商购自Victorian Chemical Co.,Richmond,Victoria Austrailia) | 1.18 |
酪蛋白钠 | 0.33 |
乳蛋白质浓缩物(80%乳蛋白质)(商购自New ZealandMilk Products,Lemoyne,PA) | 1.43 |
脱脂奶粉(商购自O-AT-KAMilk Products Cooperative,Inc.,Batavia,KY) | 4.23 |
精制糖 | 4 |
麦芽糖糊精 | 3 |
三氯蔗糖液体浓缩物(商购自McNeil Specialty,McIntosh,AL) | 0.06 |
调味剂,包括可可粉 | 1.7 |
水 | 足量 |
实施例11
制备以近似显示的量含有如下组分的11流体盎司巧克力味饮料组合物:
组分 | 重量百分比 |
聚磷酸钠 | 0.01 |
氢氧化钠 | 0.03 |
角叉菜胶(商购自FMC Biopolymer Food&SpecialtyBusiness,Philadelphia,PA) | 0.06 |
纤维素树胶(商购自FMC BiopolymerFood&Specialty Business,Philadelphia,PA) | 0.44 |
阿拉伯树胶(商购自TIC Gums,Inc.,Belcamp,MD) | 0.45 |
营养物质,包括丙酸钙 | 0.65 |
乳化剂 | 0.04 |
油酸乙酯(商购自Victorian Chemical Co.,Richmond,Victoria Austrailia) | 1.18 |
酪蛋白钠 | 0.33 |
乳蛋白质浓缩物(80%乳蛋白质)(商购自New ZealandMilk Products,Lemoyne,PA) | 2.31 |
脱脂奶粉(商购自O-AT-KAMilk Products Cooperative,Inc.,Batavia,KY) | 2.14 |
精制糖 | 4 |
麦芽糖糊精 | 3 |
三氯蔗糖液体浓缩物(商购自McNeil Specialty,McIntosh,AL) | 0.06 |
调味剂,包括可可粉 | 1.7 |
水 | 足量 |
实施例12
据如下方法制备如实施例7-11中任何一个所述的组合物。可供选择地,通过常规方法或其他方法来制备组合物。
将水加入一个高剪切搅拌装置中,开始搅拌(可任选地,装置可同例如混匀缸再循环,来进行大批量制备)。搅拌可以是,例如,从约5Watt/Kg(瓦每千克))至约150W/kg的混合能量。组合物各种组分加入的具体顺序对获得本组合物稳定和掩盖滋味的有益效果并不重要。在加入角叉菜胶或其他类似物质(如果使用)后,允许一批料搅拌约1至10分钟来进行适当的水合。另外,所有组分可顺序加入,但在各组分加入之间只有很少等候时间或没有等候时间。一旦加入了各种组分,组合物可任选地在约20.68MPa至约48.26MPa的压力下进行均化。组合物可任选地在超高温(UHT)条件下灭菌。组合物可任选地在约13.79MPa至约34.47MPa的压力下进行均化。典型地,可在灭菌之前或之后进行均化,但可在灭菌之前和之后都进行均化。组合物可任选地无菌装入合适的无菌容器。
给组分施加混合能量的装置可从多种熟知的装置(激励装置)中选择。例如,这种激励装置可以是搅拌器,它通过形成超声波振动将能量提供给液体介质,例如使用购自Sonic Corporation,Stratford,CT的Sonolator或压电换能器。Sonolator是一种通过抽吸液体、液体混合物或液体中的固体分散体以高的线性速率穿过成形的孔口,提供超声波振动的在线体系。液体流撞击悬挂在其中的刀片。刀片上流体的流动在刀片上产生振动,进而在流中产生气穴现象,将流动能转变成混合/分散能。其他尤其有用的激励装置包括提供末端高速的间歇式搅拌器,例如以商品名OSTERIZER购自Sunbeam Corporation,Delray Beach,FL的搅拌器。另外,可用购自Charles Ross&Son,Hauppauge,NY的转子/定子高剪切搅拌器。也可使用购自Quadro Inc.,Millburn,NJ的Quadro ZC/XC型在线搅拌器。另外,可用于本文的优选的激励装置包括底部传动搅拌器,例如购自Breddo Likwifier,Kansas City,MO的Breddo Likwifier(LOR型,圆缸;LTD型,方缸)和购自APV Crepaco,Inc.,LakeMills,WI的APV Mixer/Blender(Multiverter(圆缸)/Liquiverter(方缸)高速搅拌器。
实施例13
制备以近似指示的量含有如下组分的补充健康棒:使用常规方法制备这种棒。
组分 | 重量百分比 |
油酸乙酯 | 5.6 |
高果糖玉米糖浆 | 15 |
格兰诺拉麦片 | 16.4 |
燕麦纤维 | 3.2 |
蜂蜜 | 4.8 |
大豆 | 16.9 |
麦麸 | 4.7 |
麸片 | 3.8 |
巧克力 | 12 |
丙酸钙 | 0.3 |
碳水化合物糖 | 12.8 |
风味剂 | 0.7 |
甘油 | 3 |
食盐 | 0.2 |
碳酸钙 | 0.6 |
实施例14
制备以近似指示的量含有如下组分的代替正餐的健康棒。使用常规方法制备这种棒。
组分 | 重量百分比 |
油酸乙酯 | 6.6 |
高果糖玉米糖浆 | 15.5 |
格兰诺拉麦片 | 15.8 |
燕麦纤维 | 3.35 |
蜂蜜 | 6.13 |
大豆 | 21 |
麦麸 | 4.1 |
麸片 | 8 |
营养物质 | 3.1 |
丙酸钙 | 0.17 |
碳水化合物糖 | 12.7 |
风味剂 | 0.35 |
甘油 | 3 |
食盐 | 0.2 |
实施例15
制备胶囊组合物,其中该胶囊以近似显示的量含有如下组分。使用常规方法制备这种胶囊。
组分 | 重量百分比 |
油酸乙酯 | 79% |
丙酸钙 | 21% |
组分装入可由多种途径市售的“00”尺寸的胶囊。包含约1.5克油酸乙酯和约0.4克丙酸钙的胶囊是体重约70公斤的女性消费者的每日给药量。在四周时间内,消费者每周体重减轻约0.91公斤。
Claims (10)
1.组合物,所述组合物的特征在于其包含:
(a)短链脂肪酸组分,其选自乙酸、丙酸、丁酸、它们的酯、它们的盐以及它们的混合物;和
(b)长链脂肪酸组分,其选自长链脂肪酸、长链脂肪酸的非甘油酯以及它们的混合物;
其中所述组合物适于哺乳动物口服。
2.如权利要求1所述的组合物,其中所述长链脂肪酸组分与短链脂肪酸组分的比率按重量计为10∶1或更小。
3.如权利要求1所述的组合物,所述组合物的特征在于其包含按所述组合物的重量计0.001%至8%的所述短链脂肪酸组分和0.001%至10%的所述长链脂肪酸组分。
4.如权利要求1所述的组合物,其中所述短链脂肪酸组分选自丙酸、丙酸盐以及它们的混合物。
5.如权利要求2所述的组合物,其中所述长链脂肪酸组分与短链脂肪酸组分的比率按重量计为5∶1或更小。
6.如权利要求1所述的组合物,其中所述短链脂肪酸组分选自丙酸钙、丙酸钠、丙酸镁、丙酸钾以及它们的混合物,并且其中所述长链脂肪酸组分选自油酸、亚油酸、油酸甲酯、油酸乙酯、油酸正丙酯、油酸异丙酯、油酸正丁酯、油酸异丁酯、亚油酸甲酯、亚油酸乙酯、亚油酸正丙酯、亚油酸异丙酯、亚油酸正丁酯、亚油酸异丁酯以及它们的混合物。
7.如权利要求1所述的组合物,其中所述短链脂肪酸组分是丙酸钙,并且所述长链脂肪酸组分选自油酸、亚油酸、油酸乙酯以及它们的混合物。
8.如权利要求1所述的组合物,所述组合物的特征还在于其包含纤维。
9.权利要求1所述的组合物的用途,其特征在于,用于制备控制哺乳动物体重的药物。
10.如权利要求9所述的用途,所述药物的给药为每公斤所述哺乳动物0.01克至10克的所述短链脂肪酸组分和每公斤所述哺乳动物0.001克至10克的所述长链脂肪酸组分。
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Also Published As
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ATE406808T1 (de) | 2008-09-15 |
ES2312781T3 (es) | 2009-03-01 |
US20030203004A1 (en) | 2003-10-30 |
JP2005523331A (ja) | 2005-08-04 |
CA2483263A1 (en) | 2003-11-06 |
AU2003234133B2 (en) | 2007-11-01 |
HK1080689A1 (en) | 2006-05-04 |
EP1496757B1 (en) | 2008-09-03 |
WO2003090557A1 (en) | 2003-11-06 |
EP1496757A1 (en) | 2005-01-19 |
AU2003234133A1 (en) | 2003-11-10 |
CN1646032A (zh) | 2005-07-27 |
DE60323354D1 (de) | 2008-10-16 |
MXPA04010463A (es) | 2004-12-13 |
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