CN1956734A - 复合维生素和矿物质的营养补充剂 - Google Patents
复合维生素和矿物质的营养补充剂 Download PDFInfo
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- CN1956734A CN1956734A CNA2005800165431A CN200580016543A CN1956734A CN 1956734 A CN1956734 A CN 1956734A CN A2005800165431 A CNA2005800165431 A CN A2005800165431A CN 200580016543 A CN200580016543 A CN 200580016543A CN 1956734 A CN1956734 A CN 1956734A
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Abstract
本发明提供营养补充剂,该补充剂含微量营养素以促进人胆固醇降低、和/或高半胱氨酸减少和/或低密度脂蛋白-胆固醇(LDL-C)氧化减少。在一个实施方案中,补充剂为含至少一种已知降胆固醇成分的复合维生素、矿物质补充剂。本发明还提供用于将四分之一至二分之一有效日剂量含植物甾醇营养补充剂压成实用大小片剂的方法,及降低人血液胆固醇的方法。
Description
相关申请的交叉参考
本申请要求2004年3月29日提交的名称为“复合维生素和矿物质营养补充剂”的美国临时申请60/557,247的优先权,该申请的内容通过引用而整体结合到本文中,其范围与本发明和申请一致。
发明背景
本发明涉及营养补充剂。本发明的特征包括提供复合维生素和/或矿物质组分补充剂和微量营养素,以促进人的胆固醇降低,和/或高半胱氨酸减少和/或低密度脂蛋白-胆固醇(LDL-C)氧化减少。特别是,本发明涉及包括至少一种已知降低胆固醇组分的复合维生素和/或矿物质补充剂。
早已确定一般称为维生素和矿物质的许多化学化合物,即使以相对少量提供,对于维持个体健康状态和/或治疗具体的医学病症具有重要价值。多年来已鉴定许多这些维生素和矿物质。例如,维生素包括A、C、D、E和B族维生素,矿物质包括铁、锌、钙和铬。人体不能合成大多数维持人体健康必需的这些化合物。因此这些必需维生素和矿物质必须从外源获得。两种最常见的外源为食物和营养补充剂。食物一般为获得必需营养素的主要来源;然而,大部分人不会食用持续提供每日必需维生素和矿物质的食物。因此,进行维生素和矿物质营养补充已成为符合公认医学和健康标准的公认方法。
当已显示某些维生素和矿物质为维持个体健康所必需时,使用维生素和矿物质的营养补充提供包括微量营养素的可能,尽管微量营养素对维持健康不是绝对必需的,但对维持健康提供明显的好处。例如,Cooper等的美国专利第6,361,800号提供用微量营养素组合物制备的复合维生素补充剂,声称可降低血浆高半胱氨酸水平和血浆葡萄糖水平。
涉及许多个体的重大健康问题为高胆固醇的问题。尽管可提供许多药物治疗该问题,但大多数常见药物治疗需要医生监督使用且相对昂贵。在非常高或慢性提高胆固醇的情况下,当然医生关注并使用这些药物非常重要,但当胆固醇水平严重威胁健康时,需使用药物治疗。
可购买一些草药/天然维生素和/或矿物质和/或含植物甾醇的营养组合物,认为植物甾醇类化合物促进胆固醇的降低。然而,这些草药/天然产物组合物降低胆固醇的功效是可疑的,因为它们每个剂量中一般包含20-50mg植物甾醇。该量显著低于FDA(食品及药品管理局)认可的植物甾醇降低胆固醇水平的有效剂量。在2003年2月14日的21 CFR 101.83中,FDA指出800mg/天为植物甾醇减少冠心病危险的最低有效摄取量。
因此,期望方便、实用且相对经济的方式,在胆固醇达到严重威胁健康的水平之前,促进人的胆固醇水平降低和/或高半胱氨酸减少和/或LDL-C氧化减少。
发明概述
本发明提供营养补充剂,该营养补充剂在人中促进提供维生素、矿物质和其他所需微量营养素的足够摄取,以预防疾病、防止由于不适当的日常摄取模式和生活方式因素造成的营养损失和缺乏,提供促进胆固醇降低和/或高半胱氨酸减少和/或LDL胆固醇降低的微量营养素。本发明也提供制备有效剂量的实用剂型营养补充剂的方法,以及降低人中胆固醇水平和/或LDL胆固醇和/或高胱氨酸(homocystine)的方法。
在一个实施方案中,本发明提供给予人的营养补充剂,所述补充剂包含有效量的选自维生素A、维生素C、维生素E、维生素B6、维生素B2、叶酸盐和维生素B12的至少一种维生素,以及有效量的选自植物甾醇(phytosterols)、植物甾烷醇(phytostanols)、甘蔗脂肪醇(policosanols)和他汀(statins)的至少一种降胆固醇剂。
在一个实施方案中,本发明提供给予人的营养补充剂,所述补充剂包含有效量的选自硒、铬和锌的至少一种矿物质,以及有效量的选自植物甾醇、植物甾烷醇、甘蔗脂肪醇和他汀的至少一种降胆固醇剂。
在一个实施方案中,本发明提供给予人的复合维生素和矿物质营养补充剂,所述补充剂包含降低胆固醇有效量的选自植物甾醇、植物甾烷醇、甘蔗脂肪醇和他汀的至少一种降胆固醇剂,以及有效量的维生素A、B2、B6、B12、叶酸盐(叶酸)和E。该组合物还可包含至少一种有效量的番茄红素和有效量的硒。
在另一个实施方案中,本发明提供给予人的复合维生素和矿物质营养补充剂,所述补充剂包含药学上可接受形式的以下物质:至少约800mg植物甾醇;至少约3500I.U.维生素A和/或维生素A前体;至少约60mg维生素C;至少约400I.U.维生素D;至少约30I.U.维生素E;至少约25mcg维生素K;约1.5mg硫胺;至少约1.7mg维生素B2(核黄素);至少约20mg烟酸;至少约5mg维生素B6;至少约800mcg叶酸;至少约200mcg维生素B12;至少约30mcg生物素;至少约10mg泛酸;至少约6mg铁;约150mcg碘;至少约210mg镁;至少约7.5mg锌;至少约20mcg硒;至少约0.7mg铜;至少约2mg锰;至少约108mg钙;至少约80mg磷;至少约75mcg钼;至少约320mcg硼;至少约5mcg镍;至少约2mg硅;至少约10mcg锡;至少约10mcg钒;至少约120mcg铬;至少约64mg钾;至少约78mg氯化物;至少约300mcg番茄红素和至少约250mcg叶黄素。
本发明另一个实施方案提供给予人的复合维生素和矿物质营养补充剂,所述补充剂包含药学上可接受形式的以下物质:至少一种促进胆固醇降低的成分、至少一种促进高半胱氨酸减少或促进低密度脂蛋白-胆固醇(LDL-C)减少的成分和约1300I.U.至约10,000I.U.维生素A和/或维生素A前体;约200I.U.至2000I.U.维生素D;约0mcg至约50mcg维生素K;约1.2mg至约4.5mg硫胺;约5mg至约40mg烟酸;约0mg至约550mg胆碱;约0mcg至约1400mcg叶酸;约0mcg至约300mcg生物素;约0mg至约16mg泛酸;约0mg至约18mg铁;约0mcg至约300mcg碘;约0mg至约100mg镁;约3mg至约15mg锌;约0mg至约2mg铜;约0mg至约6mg锰;约0mg至约200mg钙;约0mg至约750mg磷;约0mcg至约250mcg钼;约0mcg至约150mcg硼;约0mcg至约100mcg镍;约0mg至约40mg硅;约0mcg至约35mcg锡;约0mcg至约25mcg钒;约0mcg至约300mcg铬;约0mg至约125mg钾;约0mg至约120mg氯化物;约0-3gω-3脂肪酸;约0-3g番茄红素;约0-3g玉米黄质以及约0mcg至约3g叶黄素。
促进胆固醇降低的成分可包括降低胆固醇有效量的一种或多种以下成分:游离或酯化形式的植物甾醇、植物甾烷醇或它们的等同物;甘蔗脂肪醇和他汀。合适的他汀包括如阿托伐他汀、普伐他汀、辛伐他汀、洛伐他汀或氟伐他汀。复合维生素和矿物质营养补充剂中一般可使用约0.8克至约3克植物甾醇、甾烷醇(stanols)或它们的等同物。最高达约200mg量的甘蔗脂肪醇可用于复合维生素和矿物质营养补充剂中。使用他汀的量可最高达80mg,一般使用量为约40mg至约80mg。关于他汀,更特别优选普伐他汀和辛伐他汀使用的量为约40mg,阿托伐他汀、洛伐他汀和氟伐他汀一般使用的量为约80mg。
促进高半胱氨酸减少的成分可包含一种或多种以下物质:最高达约40mg维生素B2(核黄素);最高达约10mg的维生素B6;最高达约1mg的叶酸盐和最高达约2mg的维生素B12。促进高半胱氨酸减少的成分更优选可包含一种或多种以下物质:约1.3mg至约5.1mg维生素B2(核黄素);最高达约1400至约800mcg的叶酸盐;约1mg至约6mg维生素B6以及约2.4mcg至约200mcg维生素B12。
促进低密度脂蛋白-胆固醇(LDL-C)氧化减少的成分可包含一种或多种以下物质:最高达约2克的维生素C;最高达约800I.U.的维生素E;最高达约6克的番茄红素以及最高达约350mcg的硒。促进低密度脂蛋白-胆固醇(LDL-C)氧化减少的成分更优选可包含一种或多种以下物质:约45mg至约250mg维生素C;约20I.U.至约200I.U.维生素E;约0mcg至约3g番茄红素以及约0mcg至约75mcg硒。
本文中描述的组合物还可包含稀释剂如钙化合物、镁化合物、微晶纤维素、淀粉或其组合。
本文中描述的组合物也可包含吸收剂如二氧化硅。例如,在一些实施方案中二氧化硅可为沉淀二氧化硅、热解法二氧化硅或其混合物。
本发明还提供通过给予人本发明组合物而降低人的胆固醇水平、减少高半胱氨酸和减少低密度脂蛋白-胆固醇(LDL-C)氧化的方法。
本发明还包含将含至少一种植物甾醇的营养补充剂压成片剂的方法,该方法包括:提供至少一种植物甾醇和至少一种稀释剂;于高剪切制粒条件下,将植物甾醇和至少一种稀释剂制粒,形成颗粒;碾磨颗粒;向颗粒加入吸收剂。
至于湿法制粒的方法,该方法还可包括干燥颗粒,和优选于干燥之后加入吸收剂。流化床干燥器为干燥颗粒的合适干燥器的实例。
该方法可包括压缩颗粒形成片剂。片剂可用含如聚乙烯醇(PVA)的薄膜衣料包衣。
在一个实施方案中,日有效量的营养补充剂包含两片,两片中每片体积小于2立方厘米。
在一个实施方案中,日有效量的营养补充剂包含四片或更少。每片体积小于1.5立方厘米。
在一些实施方案中,片剂可具有长椭圆形、椭圆形、改进的椭圆形或胶囊形状。
或者,日有效量的营养补充剂可包含一个或多个胶囊、一个或多个咀嚼释放单位、散剂或小药囊。
附图简述
图1为本发明组合物片剂的例示性实施方案的端视图。
图2为本发明组合物片剂的例示性实施方案的俯视图;
图3为本发明组合物片剂的例示性实施方案的侧视图;
图4为显示本发明组合物片剂的两个例示性实施方案在水中的片剂崩解数据曲线图;和
图5为显示本发明片剂的两个例示性实施方案在酸中的片剂崩解数据曲线图。
发明详述
本发明提供营养补充剂,在一个实施方案中为给予人的复合维生素和矿物质营养补充剂,所述补充剂包含至少一种促进胆固醇降低的成分。降胆固醇的成分可包括植物甾醇和/或甾烷醇和/或他汀和/或甘蔗脂肪醇。在一些实施方案中,营养补充剂还包含至少一种减少高半胱氨酸和/或减少低密度脂蛋白-胆固醇(LDL-C)的成分。该复合维生素和矿物质营养补充剂可包含一种或多种以下物质:维生素A和/或维生素A前体;维生素C;维生素D;维生素E;维生素K;硫胺;维生素B2(核黄素);烟酸;维生素B6;叶酸;维生素B12;生物素;泛酸;铁;碘;镁;锌;硒;铜;锰;钙;磷;钼;硼;镍;硅;锡;钒;铬;钾;氯化物;胆碱;番茄红素和叶黄素。当定时(如每天)给予人时,本发明组合物促进维生素和矿物质的适当摄取以及其他微量营养素的提供,以促进良好的健康,包括促进人的胆固醇水平降低和/或高半胱氨酸减少和/或低密度脂蛋白-胆固醇(LDL-C)氧化减少的微量营养素。在其它实施方案中,营养补充剂可包括与至少一种降胆固醇成分组合应用的一种或多种维生素,或与至少一种降胆固醇成分组合应用的至少一种矿物质。术语“营养补充剂”或“补充剂”应涉及任何或所有实施方案(如含有至少一种降胆固醇剂的复合维生素和矿物质补充剂、包含至少一种维生素和至少一种降胆固醇剂的组合物、或包含至少一种矿物质和至少一种降胆固醇剂的组合物)。在一些实施方案中,营养补充剂还可包含其他活性成分,如降高胱氨酸的活性成分或一种或多种提供营养和/或健康益处的其他活性成分。本发明的优选实施方案为含有至少一种降胆固醇剂的复合维生素和矿物质补充剂,因为这种补充剂提供针对营养缺乏的简单方法,并促进需要补充营养的个体在使用中的依从性。
本发明还提供制备固体剂型的方法,该固体剂型在便于人服用的一个或多个单位中包含有效量的营养补充剂组分。(例如为这样的剂型:在成人可实际吞咽大小的2-4片中含有日有效量的至少一种维生素和/或矿物质补充剂,以及至少一种降胆固醇成分)。一般营养缺乏补充营养所需要提供有效日剂量的维生素和矿物质组分的数量,通常基本上构成片体积。补充剂中提供其他促进胆固醇降低的组分,进一步增加了包含在剂型中的物质体积。
例如,制备在实际剂量单位中含有效量的相当多维生素和矿物质以及植物甾醇的固体剂型特别有挑战性,因为要符合FDA功效标准,每天最少需要800mg植物甾醇,而且植物甾醇为具有低堆密度的蜡样物质。发明人已通过开发制备方法(如制造方法)而解决这些问题,该方法采用制粒技术和/或使用稀释剂和/或使用吸收性赋形剂制备成片的剂型,该剂型在优选2-4片大小适合人吞咽的片剂中含日有效量的营养补充剂组分。
本文中使用的短语“降胆固醇剂”或“胆固醇减少剂”指当以有效量给予时,具有降低胆固醇水平特性的任何化合物、化合物的组合,包括任何提取物或植物组分、天然发现或经加工或合成的化合物。
除非另外指出,本文中指定的所有量以毫克计。术语“I.U.”表示国际单位。术语“mcg”表示微克,“mg”表示毫克,“g”表示克。此外,应理解本文公开组分的量为日剂量,该日剂量可包含一个剂量单位或多个剂量单位。
营养素的“有效剂量”基于美国食品和药品管理局(FDA)认可的提供健康或营养益处的基准,至少为每日所需营养素的最少量。我们还强调,在一些指南中,FDA推荐将复合维生素和矿物质补充剂的日剂量分开,以两个剂量单位在一天中按一定间隔服用。一般与膳食或食物一起摄入,如每日两次与膳食一起摄入。相应地给出日剂量的量,但应理解日剂量可为多剂量单位,这些单位的消耗可在一天内的同一时间或不同时间发生。
一般地,将植物来源的甾醇和甾烷醇称为植物甾醇和植物甾烷醇。植物甾醇和植物甾烷醇为天然化合物,可作为保健食物部分定时使用。因此,尽管植物来源的物质为这些化合物的优选来源,但等同的合成甾醇和甾烷醇,或来自其他来源的甾醇和甾烷醇可在本发明实践中使用。本文中任何涉及植物甾醇或植物甾烷醇的使用应认为适用于替代来源的等同甾醇或甾烷醇。应理解,根据组合物的讨论量,甾醇或植物甾醇可以相似的量使用,或者反之亦然。应理解,根据组合物的讨论量,甾烷醇或植物甾烷醇可以相似的量使用,或者反之亦然。
有许多具体化学实体归类为植物甾醇,包括但不限于如β-谷甾醇、菜子甾醇和豆甾醇。本发明营养补充剂可采用一种具体的植物甾醇类化学物质,或者包含多种具体的植物甾醇类化学物质的混合物。例如,具有β-谷甾醇、菜子甾醇和豆甾醇作为主要组分的植物甾醇混合物为适用于本发明实践中使用的混合物实例。例如,混合的植物甾醇制剂产品可从提供商如Cargill和ADM(Archer Daniels Midland)买到。同样地,在本发明实践中可使用植物甾烷醇类物质包括多种具体的植物甾烷醇类化学物质和一种具体的植物甾烷醇类化学物质,或者多种具体的植物甾烷醇类化学物质的混合物。因此,涉及本文讨论的组合物中植物甾醇或植物甾烷醇,应包括一种具体的化学类物质形式和混合物两者。
食物如水果、蔬菜、面包和其他全谷食品以及大多数植物油至少包含一些植物甾醇。然而,按照每日基准,难以充分使用这些食物来获得具有降胆固醇作用的充足植物甾醇摄取量。基于饮食中使用植物甾醇的临床试验数据,FDA推荐至少0.8克(800mg)植物甾醇的每日摄取量作为低饱和脂肪和胆固醇饮食部分,以提供显著的降胆固醇益处。服用本发明营养补充剂为确保获得有效日摄取量的一种方法。
本发明人不希望受理论束缚,但认为摄取植物甾醇和甾烷醇与胆固醇竞争以降低胆固醇在小肠的吸收和再吸收,因为它们在结构上类似于胆固醇。在这点上,进食后肠中存在的游离形式的甾醇如植物甾醇越多,发生的胆固醇吸收和再吸收就越少。此外,使用的植物甾醇、植物甾烷醇和它们的等同物不会被吸收到任何可测的程度。因此,认为植物甾醇抑制胆固醇被身体摄取并且在系统中很多也不被吸收。一项研究显示在“坏”低密度脂蛋白-胆固醇(如″LDL-C″)的血液水平中,全部结果可平均下降8-15%,并且没有观察到或鉴定出不良反应(见″Plant Sterol-Fortified Orange Juice Effectively Lowers Cholesterol LevelsIn Mildly Hypercholesterolemic Healthy Individuals(增加植物甾醇的橙汁有效降低中度高胆固醇血症的健康个体中的胆固醇水平)。″Arterioscler.Thromb.Vasc.Biol.2004年3月;24(3):e25-8.Epub 2004Feb 05)。复合维生素和矿物质营养补充剂优选包含最高达约3g的游离形式或酯化形式植物甾醇,更优选至少约800mg植物甾醇。补充剂最优选包含约800mg游离形式的植物甾醇。在一些实施方案中,植物甾醇可用植物甾烷醇替代,或可使用植物甾醇和植物甾烷醇的组合。
甘蔗脂肪醇为长链脂族饱和伯醇混合物使用的统称,其可降低总血清胆固醇和低密度脂蛋白-胆固醇(LDL-C)水平。甘蔗脂肪醇也称为如polycosanol、甘蔗原素(policosanal)、policosinal、policosinol、polycosanal、polycosinal和polycosinol。这些醇衍生自此类植物如甘蔗(Saccharum officinarium)和山药(如怀山药(Dioscorea opposita))的蜡。它们也发现于蜂蜡中。甘蔗脂肪醇中的主要长链醇为28碳1-二十八烷醇(octanosol),其次最多的是30碳1-三十烷醇。以非常低浓度存在的其他长链醇包括:1-二十二烷醇(C22)、1-二十四烷醇(C24)、1-二十六烷醇(C26)、1-二十七烷醇(C27)、1-二十九烷醇(C29)、1-三十二烷醇(C32)和1-三十四烷醇(C34)。这些长链醇为固体蜡状物质,不溶于水。它们统称为脂族醇。
报道的甘蔗脂肪醇降胆固醇活性的作用机制不明确,发明人不希望受任何理论束缚。文献中已提出关于甘蔗脂肪醇作用方法的一些理论,包括根据一些动物研究表明,甘蔗脂肪醇可通过直接下调HMG-CoA还原酶而抑制胆固醇在肝中的合成(见″Policosanol Safety DownRegulates HMG-CoA Reductase-Potential As A Component of theEsselstyn Regimen(甘蔗脂肪醇安全下调HMG-CoA还原酶-Esselstyn方法组分的可能性)。″Med.Hypotheses.2002 Sept;59(3):268-79)。其他研究也表明甘蔗脂肪醇可削弱乙酸酯与甲羟戊酸酯生成步骤之间的胆固醇合成和/或增强受体-依赖性LDL-C处理(见″Policosanol:ClinicalPharmacology and Therapeutic Significance of a New Lipid-LoweringAgent(甘蔗脂肪醇:一种新型降脂药物的临床药理和治疗意义)。″Am.Heart J.2002 Feb;143(2):356-65)。其他研究也表明甘蔗脂肪醇可减少脂质的过氧化反应(见″Effect of policosanol on In Vitro and In Vivo RatLiver Microsomal Lipid Peroxidation(甘蔗脂肪醇在体外和体内对大鼠肝微粒体脂质过氧化反应的影响)。″Arch.Med.Res.1997 Autumn;28(3):355-60)。认为长链醇显然具有不同的生物活性,如二十八烷醇本身可能不具有与甘蔗脂肪醇相同的活性,并且至少在某些情况中,在甘蔗脂肪醇中混合的所有或一些醇可协同作用。在一个实施方案中,甘蔗脂肪醇包含于复合维生素和矿物质营养补充剂中。包括polycosanol的复合维生素和矿物质营养补充剂实施方案中包含最高达约200mg的甘蔗脂肪醇,更优选约10至约20mg的甘蔗脂肪醇。
他汀包括阿托伐他汀、普伐他汀、辛伐他汀、洛伐他汀和氟伐他汀,被认为是竞争性3-羟基-3-甲基戊二酰CoA,在下文中称为HMGCoA还原酶抑制剂。因此认为它们有效降低胆固醇,并认为它们不仅有效预防心脏病发作复发,而且有效防止心脏病首次发作。在一些情况中,他汀也可减小中风的危险。在一个实施方案中,他汀可包含在复合维生素和矿物质营养补充剂中。含他汀的营养补充剂实施方案可包含最高达约80mg的他汀或他汀的混合物,更优选包含约5至约80mg的他汀或他汀的混合物。普伐他汀和辛伐他汀优选使用的量为约40mg,阿托伐他汀、洛伐他汀和氟伐他汀优选使用的量为约80mg。
已知一些维生素和矿物质促进胆固醇降低、高半胱氨酸减少和/或低密度脂蛋白-胆固醇降低。通过在复合维生素和矿物质营养补充剂中提供这些物质之一或其组合,本发明提供便利、实用且相对经济的方法,该方法促进人的胆固醇水平降低、和/或高半胱氨酸水平降低和/或LDL-C的氧化降低。
维生素C,也称为抗坏血酸,被认为是合成胶原所必需的,并被用作抗氧化剂。认为维生素C抗感染,减轻炎症,愈合伤口,通过降低LDL-C的氧化而减少心脏病的危险,降低胆固醇,减少肺癌、胃癌和食管癌的危险,减少宫颈上皮异常,抑制N-亚硝胺并降低感冒严重性。营养补充剂可包含最高达约2000mg维生素C,更优选约45mg至约250mg,最优选约60mg维生素C。
需要维生素E维护细胞膜和神经健康。维生素E减轻热潮红,缓解乳房痛,帮助抗纤维囊性乳房疾病,减少乳腺肿瘤,降低肺癌危险并通过降低LDL-C胆固醇氧化而减少心脏病危险。维生素E为一组相关物质的统称,包括α-生育酚、β-生育酚、γ-生育酚和δ-生育酚。此外,这四种化合物各自具有天然形式的″d″型以及合成形式的″dl″型。维生素E所包括所有物质的所有形式均包括在本文中。营养补充剂可包含最高达约1500I.U.维生素E,更优选约15I.U.至约800I.U.。复合维生素和矿物质营养补充剂最优选可包含约20I.U.至200I.U.维生素E。
营养补充剂可包含一种或多种B族复合维生素。包含在营养补充剂中的B族维生素可包括硫胺(维生素B1)、核黄素(维生素B2)、烟酸(维生素B3)、泛酸(维生素B5)、吡哆醇(维生素B6)、生物素、叶酸和钴胺素(维生素B12)或其组合。B族维生素为水溶性的。已知其中维生素B2、B6和维生素B12(如或者钴胺素)降低高半胱氨酸水平。然而,通常由于B族维生素的有益性质,期望所有B族维生素用于本发明的一个实施方案中。
维生素B1或硫胺帮助保持富含胶原的结缔组织和粘膜的健康,帮助维持平滑肌,帮助血细胞的形成且是正常神经系统功能所必需的。营养补充剂可包含约0.9mg至约100mg,更优选约1.2mg至约4.5mg,最优选约1.5mg硫胺。
维生素B2或核黄素为健康毛发、指甲和粘膜所必需的,且涉及红细胞的形成、高半胱氨酸的减少、抗体的生成和全面的生长。本发明营养补充剂可包含最高达约40mg的核黄素,更优选约0.9mg至约5.1mg,最优选约1.3mg至1.7mg核黄素。
维生素B3或烟酸帮助生成大多数性激素,扩张血管并帮助维持血液循环。烟酸为具有烟酸活性的一组化合物的统称,包括烟酰胺和烟酸。营养补充剂可包含约5mg至约500mg烟酸,更优选约5mg至约40mg,最优选约20mg烟酸如烟酰胺。
维生素B6或吡哆醇涉及核糖核酸(RNA)和脱氧核糖核酸(DNA)的生成、高半胱氨酸的减少和体内的许多其他反应。吡哆醇指且包括三种不同的化合物:吡哆醇、吡哆胺和吡哆醛。营养补充剂可包含约1mg至约10mg维生素B6,更优选约1mg至约6mg,最优选约5mg维生素B6。
叶酸用于红细胞的生成、激素的产生和DNA的合成。营养补充剂可包含最高达约1000mcg叶酸,更优选约0mcg至约800mcg叶酸盐(叶酸),最优选约800mcg叶酸。
维生素B12(如钴胺素)为全身代谢、神经系统功能、叶酸代谢、高半胱氨酸减少和红细胞生成所必需的。钴胺素至少有三种活性形式:氰钴胺、羟钴胺和硝基钴胺素。营养补充剂可包含最高达约2000mcg的维生素B12,更优选约2.4mcg至约200mcg,最优选约200mcg维生素B12。
生物素为糖、蛋白质和脂肪代谢所必需的,且是健康皮肤和毛发所必需的。营养补充剂可包含最高达约900mcg生物素,更优选约0mcg至约300mcg,最优选约30mcg生物素。
泛酸,也称为维生素B5,对肾上腺激素的生成、增加全身能量并帮助将食物转化成能量是重要的。营养补充剂可包含最高达约200mg泛酸,更优选约0mg至约10mg,最优选约10mg泛酸。
也期望将维生素A用于本发明复合维生素和矿物质营养补充剂中。维生素A预防夜盲和其他眼睛疾病,保持皮肤湿润和弹性,维持健康毛发、皮肤和齿龈,减少乳腺癌危险,帮助减轻乳房痛,降低肺癌危险,维持细胞结构和完整,作为抗氧化剂作用预防细胞老化,帮助预防感染及使皮肤抗皱和防止太阳损害作用。维生素A为脂溶性维生素。术语维生素A用于包括视黄醇和称为维甲酸的其他化学类似化合物。
在本发明实践中,维生素A可以维生素A的形式提供,以维生素A的前体类胡萝卜素的形式如β-胡萝卜素提供,或以其混合物的形式提供。例如,在典型的实施方案中,29%的维生素A可以β-胡萝卜素形式提供,其余的可以乙酸维生素A形式提供。本发明营养补充剂可包含最高达约10,000I.U.包括维生素A前体的维生素A,更优选约1300I.U.至约5000I.U.,并最优选约3500I.U.维生素A或维生素A与维生素A前体β-胡萝卜素形式的维生素A。
β-胡萝卜素和其他类胡萝卜素为维生素原,即维生素前体,按身体需要转化成维生素或维生素样物质。尽管类胡萝卜素包括叶黄素、玉米黄质和番茄红素,在本文中这些组分的量特别规定,本文列举的维生素A前体的任何量应理解为不包括叶黄素、玉米黄质或番茄红素的任何可测量量。
维生素D也为必需矿物质,其帮助骨矿化和钙化、预防儿童佝偻病、防止成人骨软化、保护骨和牙齿的生长并降低血压。维生素D为脂溶性的,胆钙化醇或D3为优选形式。营养补充剂优选可包含最高达约2000I.U.的维生素D,更优选约200至约400I.U.维生素D。
维生素K为活性凝血剂并帮助骨形成。它也可帮助从动脉粥样硬化性斑块中除去钙。叶绿醌或K1和menoquinone或K2为优选形式。营养补充剂优选可包含最高达约1mg的维生素K,更优选约0mcg至约90mcg维生素K,最优选约25mcg维生素K。
胆碱为神经系统功能和大脑功能必需的物质。对胆囊和肝功能也是重要的。胆碱帮助维持机体中围绕各细胞的膜的结构完整性,在神经信号、胆固醇转运和能量代谢中也起作用。在营养补充剂中,胆碱可以药学上可接受的胆碱盐如酒石酸氢盐(bitartarate)形式提供。营养补充剂可任选包含最高达约3500mg的胆碱,更优选约50mg至约550mg胆碱酒石酸氢盐形式的胆碱。
铁用于血色素和肌红蛋白的生成。在营养补充剂中,铁以药学上可接受的铁化合物形式给予。本文所用的“药学上可接受”指适合人使用而不会有不适当副反应如刺激、毒性和变应性反应的组分。有用的药学上可接受的铁化合物包括但不限于富马酸亚铁、硫酸亚铁、羰基铁、葡萄糖酸亚铁、氯化亚铁、乳酸亚铁、酒石酸亚铁、琥珀酸亚铁、谷氨酸亚铁、柠檬酸亚铁、焦磷酸亚铁、异柠檬酸胆碱亚铁(ferrouscholinisocitrate)、碳酸亚铁、糖-羧酸铁络合物及其组合。营养补充剂可包含最高达约18mg以药学上可接受的铁化合物给予的铁,更优选约5mg至约18mg铁。
碘帮助脂肪代谢,是甲状腺正常功能所必需的,减少纤维囊性乳房疾病。在本发明营养补充剂中,碘按药学上可接受的碘化合物形式给予。有用的药学上可接受的碘化合物包括但不限于碘化钾、碘化钠及其组合。营养补充剂可包含最高达约1100mcg以药学上可接受的碘化合物形式给予的碘,更优选最高达约150mcg,最优选约150mcg碘。
镁用于骨的形成和生长,防止骨损失,松弛冠状动脉,用于处理子痫前期,治疗心律失常和处理糖尿病。在营养补充剂中,镁按药学上可接受的镁化合物形式给予。有用的药学上可接受的镁化合物包括但不限于硬脂酸镁、碳酸镁、氧化镁、氢氧化镁、硫酸镁及其组合。营养补充剂可包含最高达约400mg以药学上可接受的镁化合物形式给予的镁,更优选最高达约350mg,最优选约100mg镁。
锌为DNA和RNA的正确形成所必需的,并是女性生长、免疫和性发育所需的。在本发明复合维生素和矿物质营养补充剂中,锌按药学上可接受的锌化合物形式给予。药学上可接受的锌化合物包括但不限于硫酸锌、氯化锌、氧化锌及其组合。营养补充剂可包含约3mg至约40mg以药学上可接受的锌化合物形式给予的锌,更优选约3mg至约15mg,最优选约15mg锌。
硒减少心脏病发作和心脏病的危险,减少癌症危险,防止金属中毒,并认为与维生素E协同减少LDL胆固醇氧化。药学上可接受的硒化合物包括但不限于硒酸钠、硒代半胱氨酸、硒代蛋氨酸或其他氨基酸螯合物及其组合。营养补充剂可包含最高达约400mcg的硒,更优选最高达约75mcg,最优选约15mcg至约75mcg以药学上可接受的形式给予的硒。
铜帮助保持血管弹性,为弹性蛋白和胶原形成所需,起铁氧化剂功能,为维生素C正常机能所需物质。在营养补充剂中,铜按药学上可接受的铜化合物形式给予。药学上可接受的铜化合物包括但不限于氧化铜、柠檬酸铜、硫酸铜、碳酸铜、葡糖酸铜及其组合。营养补充剂可包含最高达约10mg以药学上可接受的铜化合物形式给予的铜,更优选约1.0mg以葡糖酸铜、硫酸铜或柠檬酸铜形式给予的铜。
钙为构造机体并维持强健的骨骼和牙齿所需物质,促进神经传递并调节肌肉收缩和心跳。钙通过脱落的皮肤、指甲、毛发、汗、尿和粪便而丢失。如果摄取不充分,机体可从骨移走钙以获得矿物质,这会不利地影响骨密度,使骨更易损伤。药学上可接受的钙化合物包括但不限于碳酸钙、磷酸氢钙、磷酸三钙、葡萄糖酸钙、乳酸钙、柠檬酸钙及其组合。营养补充剂可包含最高达约1500mg的钙,更优选最高达约200mg,最优选约100mg至约162mg以药学上可接受形式给予的钙。
机体中锰的低水平可能与糖尿病有关。因此,锰似乎对控制血糖水平起作用。锰在氨基酸和某些维生素的代谢中也可能起作用。药学上可接受的锰化合物包括但不限于氯化锰、硫酸锰及其组合。营养补充剂可包含最高达约12mg以药学上可接受形式给予的锰,营养补充剂更优选可包含约0mg至约4mg锰,最优选约1mg锰。
认为硅用于构造骨骼和结缔组织的胶原。药学上可接受的硅化合物包括但不限于硅酸钠、硅铝酸钠、二氧化硅及其组合。营养补充剂可包含约0mg至约500mg以药学上可接受形式给予的硅,更优选约0mg至约60mg硅,最优选约2mg硅。
钼可促进脂肪、糖和铁的正常代谢并可预防某些癌症。药学上可接受的钼化合物包括但不限于钼酸钠、钼氨基酸螯合物及其组合。营养补充剂可包含最高达约2000mcg以药学上可接受形式给予的钼。营养补充剂更优选可包含约0mcg至约75mcg,营养补充剂最优选包含约75mcg钼。
认为钒在调节血糖水平中起作用。药学上可接受的钒化合物包括但不限于酒石酸钒铵、偏钒酸钠、硫酸氧钒及其组合。营养补充剂可包含最高达约1.8mg药学上可接受形式的钒,更优选约6mcg至约18mcg钒,最优选约10mcg钒。
硼在矿物质代谢中起作用。药学上可接受的硼化合物包括但不限于硼酸钠、柠檬酸硼、硼氨基酸螯合物及其组合。营养补充剂可包含最高达约20mg以药学上可接受形式给予的硼,更优选约0mcg至约1.35mg硼,最优选约150mcg至约350mcg硼。
镍可激活或抑制一些酶或激素的作用。药学上可接受的镍化合物包括但不限于硫酸镍。营养补充剂可包含最高达约1.0mg以药学上可接受形式给予的镍,更优选约0mcg至约100mcg镍,最优选约5mcg镍。
已知在人体中发现锡。在大鼠中锡缺乏可抑制生长。药学上可接受的锡化合物包括但不限于氯化亚锡。营养补充剂可包含最高达约200mcg以药学上可接受形式给予的锡,更优选约0mcg至约10mcg锡,最优选约10mcg锡。
磷为骨发育所需,并为所有大类生物化学化合物的成分。三磷酸腺苷中磷酸盐形式的磷为大多数代谢过程所需的主要能量源。药学上可接受的磷化合物包括但不限于磷酸钙、磷酸钠、磷酸钾、磷酸铵、甘油磷酸酯及其组合形式。营养补充剂可包含最高达约1250mg以药学上可接受形式给予的磷,更优选约0mg至750mg,最优选约109mg的磷。
铬帮助调节葡萄糖代谢,用于脂肪酸和胆固醇的合成,帮助转运蛋白质,降低LDL血水平并提高高密度脂蛋白血水平。在营养补充剂中,铬以药学上可接受的铬化合物给予。有用的药学上可接受的铬化合物包括但不限于氯化铬、酵母铬(yeast-bound chromium)、吡啶甲酸铬、烟酸结合铬(niacin-bound chromium)及其组合。营养补充剂可包含最高达约10mg以药学上可接受形式给予的铬,更优选约0mcg至约150mcg铬,最优选约120mcg铬。
钾为调节水平衡、酸度水平、血压和神经肌肉功能所需的。糖和蛋白质代谢也需要钾。在营养补充剂中,钾以药学上可接受的钾化合物形式给予。有用的药学上可接受的钾化合物包括但不限于氯化钾、硫酸钾、甘油磷酸钾、柠檬酸钾、葡萄糖酸钾、磷酸钾及其组合。营养补充剂可包含最高达约3900mg以药学上可接受的钾化合物形式给予的钾,更优选约0mg至约80mg钾,最优选约50mg至约80mg钾。
已发现番茄红素减少癌症危险,也发现通过其抗氧化能力降低LDL胆固醇氧化。番茄红素主要于番茄、红葡萄柚、西瓜和其他来源中发现,并为类胡萝卜素。营养补充剂可包含最高达约6g的番茄红素,更优选约0mcg至约3g番茄红素,最优选约300mcg番茄红素。
叶黄素和玉米黄质为类胡萝卜素抗氧化剂,帮助维持视力健康,且已发现减少癌症和心脏病的危险。已发现叶黄素降低黄斑变性的危险并防止其进展,黄斑变性为65岁以上老人失明的主要原因。叶黄素和玉米黄质主要在黄玉米、蛋黄、菠菜、椰菜和其他绿叶植物中发现。营养补充剂可包含最高达约6g药学上可接受形式的叶黄素,更优选约0mcg至约3g叶黄素,最优选约250mcg叶黄素。营养补充剂可包含最高达约6g药学上可接受形式的玉米黄质,更优选约0mcg至约3g玉米黄质,最优选约300mcg玉米黄质。
流行病学和干预试验已证明心血管受益于ω-3脂肪酸水平的增高。在近年(2002)的Meta分析中Bucher等发现ω-3脂肪酸在随机对照试验中的有利作用。该分析包括7951位患者的11项试验。Bucher等″N-3 Polyunsaturated Fatty Acids in Coronary Heart Disearch:A meta-Analysis of Randomized Control Trials(N-3多不饱和脂肪酸在冠心病中:随机对照试验的Meta分析);″Am.J.Med.;Mar.2002,112(4):pp298-304。该试验包括饮食和补充剂来源的ω-3脂肪酸。在从饮食和补充剂来源摄取ω-3脂肪酸增加的人群中,他们证实心脏猝死率在统计学上显著降低30%。营养补充剂优选包含最高达约6g的ω-3脂肪酸,更优选约0g至约3g,最优选约1gω-3脂肪酸。
氯化物为帮助维持机体离子和体液平衡所需,是胃和肠分泌物的主要组分。有用的药学上可接受的氯化物化合物包括但不限于氯化钠、氯化铬、氯化亚锡和氯化钾。复合维生素和矿物质营养补充剂优选包含最高达约100mg氯化物,更优选约0mg至约80mg,最优选约50mg至约75mg氯化物。
本发明复合维生素和矿物质营养补充剂将用于经口给予,可以固体形式提供。除活性物质之外,复合维生素和矿物质营养补充剂还可包含赋形剂和加工助剂如:吸收剂、稀释剂、调味剂、着色剂、稳定剂、填充剂、粘合剂、崩解剂、润滑剂、润湿剂、助流剂、抗粘剂、糖或薄膜包衣剂、防腐剂、缓冲剂、人造甜味剂、天然甜味剂、分散剂、增稠剂、增溶剂等或其某些组合。
本发明的剂型一般可考虑是固体。然而,它们可包含液体或半固体组分。本发明合适的固体剂型包括但不限于片剂、胶囊形片剂、包含软凝胶胶囊的胶囊剂、咀嚼剂型和小药囊等。日剂量可包含在单个释药单位中或者可包含多个释药单位。例如,如果使用片剂,可能需要将日剂量分在多个释药单位中,以提供便于吞咽的片大小。如果使用多个释药单位,如果需要,它们可在剂量期(如一般一天)期间一次给予或间隔给予。目前FDA指南推荐将日剂量分开,于一定间隔以两个剂量单位服用。然而,我们注意到至少三个当前的临床研究指出植物甾醇每日一次的剂量是有效的。(见Plat J.等,Effects On Serum Lipids,Lipoproteins and Fat Soluble Antioxidant Concentrations of ConsuptionFrequency of Margarines and Shortenings Enriched With Plant Sterol Esters(人造黄油和富含植物甾醇酯的起酥油的使用频率对血清脂质、脂蛋白和脂溶性抗氧化剂浓度的影响)。Eur J Clin Nutr 2000,54:671-677;Matvienko OA等,A Single Daily Dose of Soybean Phytosterols in GroundBeef Decreases Serum Total Cholesterol and LDL Cholesterol in YoungMildly Hypercholesterolemeic Men(绞细牛肉中单个日剂量的大豆植物甾醇减少轻度高胆固醇血症年轻男性中血清总胆固醇和LDL胆固醇)。Am J Clin Nutr 2002,76:57-64;和Volpe,R.等,Effects of YogurtEnriched With Plant Sterols on Serum Lipids in Patients With ModerateHypercholesterolemia(富含植物甾醇的酸乳对中度高胆固醇血症患者中血清脂质的影响)。British Journal of Nutrition.2001;86:233-39。)
因此,应理解本文公开的维生素、矿物质和降胆固醇剂的量为日剂量,该剂量可以单个释放单位或多个释放单位释放。在一些实施方案中,可使用包装设计来帮助消费者确认适当日剂量。例如,可使用带有标明日剂量标签的泡罩包装。
含甾醇如植物甾醇的压片组合物面临挑战。植物甾醇具有蜡的性质,疏水,其微粉化形式流动性一般不好,堆密度低。在片剂制备(压片)过程中这些特性引起问题,包括但不限于物质剩余和粘结至加工设备上,在压缩过程中物质粘附在压片机转盘上,片重控制差。此外,植物甾醇难以碾磨,因为它容易阻塞磨粉筛,除非深冷碾磨(cryo-milled)。在本发明之前,植物甾醇含量高的片剂一般显示出可压性差,一旦被压缩片剂崩解慢,不利地影响摄取后植物甾醇的释放。认为及时崩解对功效是重要的。因为发明人认为(不希望受任何理论束缚)植物甾醇在胃肠道中以原始颗粒形式作用。
发明人意外地发现使用某些制粒方法,可以其大小可被人吞咽的单个片剂,得到包含至少一半有效日剂量的植物甾醇和至少一种其他维生素或矿物质的片剂。此外,本发明片剂在与胃排空时间一致的时间内崩解成原始颗粒,如认为含压缩植物甾醇的本发明片剂在到达胃肠道之前基本上崩解。在一个实施方案中,将至少一半有效日剂量的植物甾醇和至少一半有效日剂量的多种维生素和矿物质压成一个片,该一个片可被人吞咽,且在与胃排空一致的时间内崩解。在一个实施方案中,营养补充剂的有效日剂量包含在两片中,优选每片的体积小于约2立方厘米。
在另一个实施方案中,本发明营养补充剂的有效日剂量被压成四片或更少,每片的大小可被人吞咽。当有效日剂量包含在三或四片中,每片的体积优选为约1.5立方厘米或更小。
认为营养补充剂的片剂形状对一些可提高使用者依从性的因素有贡献。例如,不受理论束缚,发明人认为压缩成体积约1.5立方厘米或更小的长椭圆形、椭圆形、改进的椭圆形和胶囊形状,比压缩成约1.5立方厘米或更小的圆形更易于消费者吞咽。在一些情况中,易于吞咽的片剂可提高使用者对给药方案的依从性。图1-3显示片剂形状的例示性实施方案。本领域技术人员可认识到,该形状为例示性形状,任何许多其他形状可同样地适用于本发明实践。
在一个实施方案中,可使用高剪切湿法制粒方法制备片剂。在例示性高剪切湿法制粒方法中,将植物甾醇与至少一种稀释剂制粒。稀释剂可包含一种或多种本文描述的无机矿物质营养素,如镁化合物或钙化合物、其他活性剂;无活性稀释剂如纤维素、纤维素衍生物、乳糖或其他糖、多元醇、淀粉、淀粉衍生物、聚合物或其混合物。使用一种或多种无机矿物质营养素为稀释剂或稀释剂的一部分,具有使加入赋形剂最少化和促进形成更小片剂的优势。磷酸氢钙和氧化镁为具体镁和钙化合物的示例,两者都可起营养素作用且用作稀释剂。这些稀释剂为例示性稀释剂,本领域技术人员熟知的其他稀释剂和制粒组分或其混合物可用于制粒。可加入本领域技术人员熟知的其他制粒赋形剂,如聚维酮、崩解剂、共-崩解剂、超级崩解剂、表面活性剂、助流剂、润滑剂和粘合剂。此外,其他活性剂如低剂量矿物质活性剂可被包含于制粒混合物中。在颗粒中包含其他低剂量活性剂仅可对颗粒性质有适度贡献,但是加入至颗粒混合物中可促进这些低剂量活性剂均匀分布。在一个例示性实施方案中,进行制粒的混合物包含植物甾醇、稀释剂、粘合剂聚乙烯吡咯烷酮(PVP)、赋形剂交联聚维酮和水。将水缓慢加入至其余组分中,同时将它们在高剪切制粒机中混合。
可任选干燥颗粒。干燥可在如流化床干燥器中进行。将颗粒碾磨成合适粒度。在一个例示性实施方案中,使用0.05筛。然而,本领域技术人员会认识到,可采用例示性尺寸和其他尺寸。在碾磨之后,将碾磨过的颗粒与吸收剂混合。二氧化硅为合适吸收剂的实例。本领域技术人员熟知的其他吸收剂物质也可用于本发明实践中。
其他维生素、矿物质和降胆固醇剂可与吸收剂一起混合至碾磨过的颗粒中,优选在一部分吸收剂与颗粒混合之后,按顺序共混。这些另外的组分可作为单一组分、预混物或其组合加入。可任选包含其他赋形剂如调味剂、着色剂、稳定剂、填充剂、粘合剂、崩解剂、润滑剂、研磨剂、助流剂、抗粘剂、防腐剂、缓冲剂、甜味剂、分散剂、增稠剂、增溶剂等或其组合。
在共混之后,组合物可使用如压缩的方法压成片剂。任选片剂可使用本领域技术人员熟知的片剂包衣材料和方法包衣。已发现植物甾醇的蜡样特性,使薄膜包衣材料难以粘附至片芯。发明人已发现,使用含聚乙烯醇的水基薄膜包衣系统可获得满意的粘附。此外,不希望受理论束缚,发明人认为使用含聚乙烯醇的薄膜包衣通过制备更易吞咽的片剂,可以提高患者的依从性。
不希望受理论束缚,发明人认为他们的发现即植物甾醇颗粒与吸收剂按顺序共混,将颗粒包衣或部分包衣促进片剂的崩解。因此发明人的发现解决了未处理蜡样植物甾醇容易形成致密物并具有不理想的长崩解时间问题。如果有,原始颗粒仅最低限度地崩解,未处理的致密化合物可能就通过胃肠道,而认为原始颗粒崩解对于功效是必需的。
发明人还认为吸收剂颗粒的物理性质和大小可调节片剂的崩解速率。如发明人已发现,当吸收剂二氧化硅与植物甾醇使用的比例为1∶8w/w时,观察到使用约0.2-0.3微米粒度、每克约200平方米表面积的热解法二氧化硅,比使用约7微米粒度、每克约300平方米表面积的沉淀二氧化硅崩解慢。发明人认为,优选使用上述的沉淀二氧化硅为吸收剂以便迅速释放植物甾醇营养补充剂,上述的热解法二氧化硅作吸收剂可用于调节崩解速率。由于在一些实施方案中,吸收剂的物理性质和尺寸似乎影响崩解速率,因此可能需要使用各类型和/或粒度的吸收剂混合物,以帮助获得理想的崩解曲线。尽管谈到的二氧化硅在本文中作为吸收剂,但发明人注意到二氧化硅也可起吸附剂作用(如它可作为吸附剂)。对于本公开的目的,吸收剂和吸附剂之间的差别并不重要,涉及的吸收剂应认为包括吸收剂、吸附剂、吸着剂或其组合。
图4和5显示本发明组合物的两个实例分别在水和酸中的例示性崩解数据。图4和5中的所有实例具有与胃肠道中及时崩解一致的崩解时间。然而,时间会根据图4和5显示所用二氧化硅的形状而改变。
本文描述的高剪切制粒方法为适用于制备本发明组合物方法的示例。发明人也注意到本文描述的湿法制粒方法不需要昂贵的深冷碾磨。或者,如干法压片(dry slugging)、干法辊压(dry roller compaction)或挤出方法可用于制备本发明组合物。
营养补充剂可任选以液体和/或半固体制剂形式提供。除了活性物质之外,这些液体和/或半固体制剂可包括赋形剂和加工助剂如:调味剂、着色剂、稳定剂、缓冲剂、人造甜味剂、天然甜味剂、螯合剂和/或络合剂、分散剂、增稠剂、增溶剂、润湿剂、抗氧化剂、乳化剂、水、乙醇、甘油、丙二醇等或其一些组合。在复合维生素制剂的单位剂量中,活性物质的数量根据活性组分的具体应用和效力而改变。
确定特定情形的合适剂量在本领域技能范围内。复合维生素和矿物质营养补充剂任选可以控释制剂形式提供。
尽管本发明组合物将优选用于人服用,但应理解该制剂也可用于动物的兽医应用。
实施例1
复合维生素和矿物质营养补充剂
本发明组合物的例示性实施方案见表1提供。该组合物有代表性,为本发明范围内许多组合物之一,并为举例说明目的提供。实施例1中举例说明的复合维生素和矿物质营养补充剂将为日剂量,一般以一个或多个剂量单位(如一至四片)给予。如果使用多个剂量单位,它们可在一天内一次性或按一定间隔服用。
表1
成分 | 量/天 |
锌 | 7.5mg |
维生素K | 25mcg |
维生素E | 100IU |
维生素D | 400IU |
维生素C | 60mg |
维生素B6 | 5mg |
维生素B2(核黄素) | 1.7mg |
维生素B12 | 200mcg |
维生素A(和维生素A前体) | 3500IU |
钒 | 10mcg |
锡 | 10mcg |
硫胺 | 1.5mg |
硅 | 2mg |
硒 | 40mcg |
钾 | 80mg |
植物甾醇 | 800mg |
磷 | 109mg |
泛酸 | 10mg |
镍 | 5mcg |
烟酸 | 20mg |
钼 | 75mcg |
锰 | 2mg |
镁 | 100mg |
番茄红素 | 300mcg |
叶黄素 | 250mcg |
铁 | 6mg |
碘 | 150mcg |
叶酸 | 800mcg |
铜 | 0.7mg |
铬 | 120mcg |
氯化物 | 72mg |
钙 | 162mg |
硼 | 150mcg |
生物素 | 30mcg |
实施例2
复合维生素和矿物质营养补充剂
本发明组合物另一个例示性实施方案见表2提供。这为本发明范围内组合物的另一个代表性组合物,为举例说明目的提供。实施例2的复合维生素和矿物质营养补充剂将为日剂量,一般以一个或多个剂量单位(如一至四片)给予。如果使用多个剂量单位,它们可在一天内一次性或按一定间隔服用。
表2
成分 | 量/天 |
锌 | 7.5mg |
玉米黄质 | 300mcg |
维生素K | 25mcg |
维生素E | 45IU |
维生素D | 400IU |
维生素C | 90mg |
维生素B6 | 3mg |
维生素B2(核黄素) | 1.7mg |
维生素B12 | 25mg |
维生素A(和维生素A前体) | 3500IU |
钒 | 10mcg |
硫胺 | 1.5mg |
硅 | 2mg |
硒 | 55mg |
钾 | 80mcg |
植物甾醇 | 800mg |
磷 | 100mg |
泛酸 | 10mg |
镍 | 5mcg |
烟酸 | 16mg |
钼 | 45mcg |
锰 | 2.3mg |
镁 | 100mg |
番茄红素 | 600mcg |
叶黄素 | 500mcg |
碘 | 150mcg |
叶酸 | 600mcg |
铜 | 0.7mg |
铬 | 50mcg |
胆碱 | 55mg |
氯化物 | 72mg |
钙 | 200mg |
硼 | 150mcg |
生物素 | 30mcg |
实施例3
复合维生素和矿物质营养补充剂
本发明组合物另一个例示性实施方案见表3提供。这为本发明范围内组合物的另一个代表性组合物,并为举例说明目的提供。实施例3的复合维生素和矿物质营养补充剂将为日剂量,一般以一个或多个剂量单位(如一至四片)给予。如果使用多个剂量单位,它们可在一天内一次性或按一定间隔服用。
表3
成分 | 量/天 |
锌 | 7.5mg |
维生素K | 25mcg |
维生素E | 30IU |
维生素D | 400IU |
维生素C | 60mg |
维生素B6 | 5.0mg |
维生素B2(核黄素) | 1.7mg |
维生素B12 | 20mcg |
维生素A(和维生素A前体) | 3500IU |
钒 | 10mcg |
硫胺 | 1.5mg |
硅 | 2mg |
硒 | 20mcg |
钾 | 64mg |
植物甾醇 | 800mg |
磷 | 80mg |
泛酸 | 10mg |
镍 | 5mcg |
烟酸 | 20mg |
钼 | 75mcg |
锰 | 2.0mg |
镁 | 40mg |
番茄红素 | 300mcg |
叶黄素 | 250mcg |
碘 | 150mcg |
叶酸 | 800mcg |
铜 | 0.7mg |
铬 | 120mcg |
氯化物 | 58mg |
钙 | 108mg |
硼 | 32mcg |
生物素 | 30mcg |
铁 | 6mg |
锡 | 10mcg |
实施例4
制备营养补充剂的方法
使用下面的湿法制粒方法,制备含多种维生素和矿物质营养补充剂组分和植物甾醇的一种例示性复合维生素和矿物质营养补充剂。
使用配备筛的低能振动系统将植物甾醇结块打破。然后将不结块的植物甾醇转移至高剪切制粒机中,并与MgO混合,向制粒筒体中加入磷酸氢钙稀释剂(也是活性剂)、ZnO(低剂量矿物质活性剂)、微晶纤维素、超级崩解剂和聚乙烯吡咯烷(polyvinyl pyrrolidine)粘合剂。制粒开始时低速共混,并在混合下缓慢加入水,形成可接受的颗粒。本领域技术人员熟悉可接受颗粒的外观和物理特征。
一旦获得可接受的颗粒,即于流化床干燥器中用空气干燥颗粒,气流入口的温度约90℃。干燥颗粒至水分含量不大于约1.5%w/w,通过红外干燥平衡的损失测得。
冷却干燥颗粒并以中等速度碾磨,刀朝前,用0.050筛。将约一半碾磨过的颗粒置于前置式锥形搅拌机(slant cone blender)中,接着将二氧化硅用20目筛过筛。加入其余碾磨过的颗粒并将混合物共混。
加入另外的活性成分和赋形剂,包括抗坏血酸和乙酸维生素E、磷酸氢钙(第二部分)、氯化铬、钼酸钠、氯化亚锡、偏钒酸钠、硫酸镍、硒酸钠、硫酸锰、生物素、维生素K、核黄素、一硝酸硫胺、碘化钾、烟酰胺、硫酸铜、泛酸钙、盐酸吡哆醇、叶酸、氰钴胺、氯化钾、富马酸亚铁、乙酸维生素A、β胡萝卜素、维生素D3、番茄红素、叶黄素、交联羧甲基纤维素钠、交联聚维酮和微晶纤维素(第二部分),并共混约10分钟。将硬脂酸镁过20目筛,加入组合物中,并继续共混约1.5分钟。
使用本领域技术人员熟知的压片技术,用压片设备将如此所得颗粒压缩成椭圆形片。发明人认为长椭圆形、改进的椭圆形和胶囊形压缩体,可比相同体积的圆形压缩体更易让消费者吞咽。在该实施方案中,植物甾醇与指定维生素和矿物质的有效日剂量被压成两片,每片具有约1.2cm3的体积。
然后,使用含聚乙烯醇的水基薄膜包衣系统对片剂包衣。
尽管为了清楚理解目的,通过举例说明和实施例已对前述本发明进行了详细描述,但是很明显,可实施的某些变化和修改在权利要求书的范围内。实施本发明的上述修改方式对技术人员或本领域技术人员是显而易见的,将被包括在权利要求书的范围内。
Claims (33)
1.一种给予人的营养补充剂,所述补充剂包含:
至少一种有效量的维生素,该维生素选自维生素A、维生素C、维生素B6、维生素B2、叶酸盐、维生素B12、维生素E;和至少一种有效量的降胆固醇剂,该降胆固醇剂选自植物甾烷醇、植物甾醇、甘蔗脂肪醇和他汀。
2.一种给予人的营养补充剂,所述补充剂包含:
至少一种有效量的矿物质,该矿物质选自硒、铬和锌;和至少一种有效量的降胆固醇剂,该降胆固醇剂选自植物甾醇、植物甾烷醇、甘蔗脂肪醇和他汀。
3.一种给予人的营养和矿物质补充剂,所述补充剂包含:
有效量的维生素A;
有效量的维生素C;
有效量的维生素B6;
有效量的维生素B2;
有效量的叶酸盐;
有效量的维生素B12;
有效量的维生素E;和
至少一种选自植物甾醇、植物甾烷醇、甘蔗脂肪醇和他汀的降胆固醇剂,其中所述至少一种降胆固醇剂以有效降低胆固醇的量存在。
4.权利要求3的组合物,所述组合物还包含至少一种有效量的番茄红素和有效量的硒。
5.一种给予人的营养补充剂,所述补充剂包含:
至少约800mg植物甾醇;
至少约3500I.U.维生素A和维生素A前体;
至少约60mg维生素C;
至少约400I.U.维生素D;
至少约30I.U.维生素E;
至少约25mcg维生素K;
至少约1.5mg硫胺;
至少约1.7mg维生素B2(核黄素);
至少约20mg烟酸;
至少约5mg维生素B6;
至少约800mcg叶酸;
至少约200mcg维生素B12;
至少约30mcg生物素;
至少约10mg泛酸;
至少约6mg以药学上可接受的铁化合物形式给予的铁;
至少约150mcg以药学上可接受的碘化合物形式给予的碘;
至少约40mg以药学上可接受的镁化合物形式给予的镁;
至少约7.5mg以药学上可接受的锌化合物形式给予的锌;
至少约20mcg以药学上可接受的硒化合物形式给予的硒;
至少约0.7mg以药学上可接受的铜化合物形式给予的铜;
至少约2mg以药学上可接受的锰化合物形式给予的锰;
至少约108mg以药学上可接受的钙化合物形式给予的钙;
至少约80mg以药学上可接受的磷化合物给予的磷;
至少约75mcg以药学上可接受的钼化合物给予的钼;
至少约32mcg以药学上可接受的硼化合物给予的硼;
至少约5mcg以药学上可接受的镍化合物给予的镍;
至少约2mg以药学上可接受的硅化合物给予的硅;
至少约10mcg以药学上可接受的锡化合物给予的锡;
至少约10mcg以药学上可接受的钒化合物给予的钒;
至少约120mcg以药学上可接受的铬化合物形式给予的铬;
至少约64mg以药学上可接受的钾化合物形式给予的钾;
至少约58mg以药学上可接受的氯化物化合物形式给予的氯化物;
至少约300mcg以药学上可接受的番茄红素化合物形式给予的番茄红素;和
至少约250mcg以药学上可接受的叶黄素化合物形式给予的叶黄素。
6.一种给予人的营养补充剂,所述补充剂包含:
约800mg至约3g植物甾醇;
约1300I.U.至约12,000I.U.维生素A;
约45mg至约250mg维生素C;
约200I.U.至约2000I.U.维生素D;
约20I.U.至约200I.U.维生素E;
约10mcg至约90mcg维生素K;
约1.2mg至约4.5mg硫胺;
约1.3mg至约5.1mg维生素B2(核黄素);
约0mg至约550mg胆碱;
约5mg至约40mg烟酸;
约1mg至约8mg维生素B6;
约0mcg至约1400mcg叶酸;
约2.4mcg至约400mcg维生素B12;
约0mcg至300mcg生物素;
约0mg至约16mg泛酸;
约0mg至约18mg以药学上可接受的铁化合物形式给予的铁;
约0mcg至约300mcg以药学上可接受的碘化合物形式给予的碘;
约0mg至约100mg以药学上可接受的镁化合物形式给予的镁;
约3mg至约15mg以药学上可接受的锌化合物形式给予的锌;
约15mcg至约75mcg以药学上可接受的硒化合物形式给予的硒;
约0mg至约10mg以药学上可接受的铜化合物形式给予的铜;
约0mg至约6mg以药学上可接受的锰化合物形式给予的锰;
约0mg至约200mg以药学上可接受的钙化合物形式给予的钙;
约0mg至约750mg以药学上可接受的磷化合物给予的磷;
约0mcg至约250mcg以药学上可接受的钼化合物给予的钼;
约0mg至约1.35mg以药学上可接受的硼化合物给予的硼;
约0mcg至约100mcg以药学上可接受的镍化合物给予的镍;
约0mg至约40mg以药学上可接受的硅化合物给予的硅;
约0mcg至约35mcg以药学上可接受的锡化合物给予的锡;
约6mcg至约25mcg以药学上可接受的钒化合物给予的钒;
约0mcg至约300mcg以药学上可接受的铬化合物形式给予的铬;
约0mg至约125mg以药学上可接受的钾化合物形式给予的钾;
约0mg至约120mg以药学上可接受的氯化物化合物形式给予的氯化物;
约0g至约3gω-3脂肪酸;
约0g至约3g以药学上可接受的番茄红素化合物形式给予的番茄红素;
约0g至约3g以药学上可接受的玉米黄质化合物形式给予的玉米黄质;和
约0g至约3g以药学上可接受的叶黄素化合物形式给予的叶黄素。
7.一种给予人的营养补充剂,所述补充剂包含:
最高达约3g植物甾醇或植物甾烷醇;
最高达约20mg甘蔗脂肪醇;
最高达约40至80mg他汀;
最高达约10,000I.U.维生素A和维生素A前体;
最高达约2g维生素C;
最高达约2000I.U.维生素D;
最高达约1500I.U.维生素E;
最高达约1mg维生素K;
最高达约100mg硫胺;
最高达约40mg维生素B2(核黄素);
最高达约500mg烟酸;
最高达约10mg维生素B6;
最高达约1.5mg叶酸;
最高达约2mg维生素B12;
最高达约900mcg生物素;
最高达约200mg泛酸;
最高达约3500mg以药学上可接受的胆碱化合物形式给予的胆碱;
最高达约18mg以药学上可接受的铁化合物形式给予的铁;
最高达约1100mcg以药学上可接受的碘化合物形式给予的碘;
最高达约400mg以药学上可接受的镁化合物形式给予的镁;
最高达约40mg以药学上可接受的锌化合物形式给予的锌;
最高达约400mcg以药学上可接受的硒化合物形式给予的硒;
最高达约10mg以药学上可接受的铜化合物形式给予的铜;
最高达约12mg以药学上可接受的锰化合物形式给予的锰;
最高达约1500mg以药学上可接受的钙化合物形式给予的钙;
最高达约1250mg以药学上可接受的磷化合物给予的磷;
最高达约2000mcg以药学上可接受的钼化合物给予的钼;
最高达约20mg以药学上可接受的硼化合物给予的硼;
最高达约1mg以药学上可接受的镍化合物给予的镍;
最高达约500mg以药学上可接受的硅化合物给予的硅;
最高达约200mcg以药学上可接受的锡化合物给予的锡;
最高达约1.8mg以药学上可接受的钒化合物给予的钒;
最高达约10mg以药学上可接受的铬化合物形式给予的铬;
最高达约3900mg以药学上可接受的钾化合物形式给予的钾;
最高达约150mg以药学上可接受的氯化物化合物形式给予的氯化物;
最高达约6gω-3脂肪酸;
最高达约6g以药学上可接受的番茄红素化合物形式给予的番茄红素;
最高达约6g以药学上可接受的玉米黄质化合物形式给予的玉米黄质;和
最高达约6g以药学上可接受的叶黄素化合物形式给予的叶黄素。
8.权利要求1-7中任一项的营养补充剂,所述补充剂还包含稀释剂。
9.权利要求8的营养补充剂,其中所述稀释剂选自钙化合物、镁化合物、微晶纤维素、淀粉及其组合。
10.权利要求1-9中任一项的营养补充剂,所述补充剂还包含吸收剂。
11.权利要求10的营养补充剂,其中所述吸收剂为二氧化硅。
12.权利要求11的营养补充剂,其中所述二氧化硅选自热解法二氧化硅、沉淀二氧化硅及其混合物。
13.一种给人补充营养促进血液胆固醇降低的方法,所述方法包括提供给人有效量的权利要求1-12中任一项的营养补充剂。
14.一种用于营养补充剂压片的制粒方法,其中所述营养补充剂包含至少一种植物甾醇,所述方法包括:
提供至少一种植物甾醇和至少一种稀释剂;
于高剪切制粒条件下,将所述植物甾醇和所述至少一种稀释剂制成颗粒;
碾磨所述颗粒;和
将吸收剂加至该颗粒中,
并压缩该颗粒形成片剂。
15.权利要求14的方法,所述方法还包括加入至少一种选自维生素和矿物质及其混合物的营养素。
16.权利要求14的方法,所述方法还包括干燥所述颗粒。
17.权利要求16的方法,其中所述干燥在流化床干燥器中进行。
18.权利要求14的方法,其中所述稀释剂包含至少一种矿物质。
19.权利要求14的方法,其中至少部分所述稀释剂选自钙化合物和镁化合物或其混合物。
20.权利要求14的方法,其中所述吸收剂为二氧化硅。
21.权利要求20的方法,其中所述二氧化硅选自热解法二氧化硅、沉淀二氧化硅及其混合物。
22.权利要求14的方法,其中所述片剂一旦形成就包衣。
23.权利要求22的方法,其中所述片剂用薄膜衣料包衣,该薄膜衣料包含聚乙烯醇。
24.权利要求1-12中任一项的补充剂,所述补充剂为选自以下的形式:片剂、胶囊形片剂、胶囊剂、咀嚼剂量单位或小药囊。
25.权利要求24的补充剂,所述补充剂为片剂形式。
26.权利要求25的补充剂,其中所述片剂包衣。
27.权利要求26的补充剂,其中所述包衣为薄膜包衣。
28.权利要求27的补充剂,其中所述薄膜衣包含聚乙烯醇。
29.一种给人补充营养的方法,其中所述补充降低或减少胆固醇,降低或减小高胱氨酸水平或降低或减小低密度脂蛋白胆固醇氧化,所述方法包括提供人有效量的权利要求1-12中任一项的营养补充剂。
30.权利要求1-12中任一项的营养补充剂,所述营养补充剂的日有效量包含两片,该两片中每片的体积小于约2立方厘米。
31.权利要求1-12中任一项的营养补充剂,其中日有效量包含四片或更少,且其中每片的体积小于1.5立方厘米。
32.权利要求30和31的营养补充剂,其中所述片剂具有长椭圆形、胶囊形、改进的椭圆形或椭圆形形状。
33.权利要求30-32中任一项的营养补充剂,其中所述片剂用包含聚乙烯醇的薄膜衣料包衣。
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PCT/US2005/010467 WO2005094333A2 (en) | 2004-03-29 | 2005-03-28 | Multi-vitamin and mineral nutritional supplements |
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2005
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