CN101330840A - 用于抑制黄斑变性进展和促进健康视觉的组合物和方法 - Google Patents
用于抑制黄斑变性进展和促进健康视觉的组合物和方法 Download PDFInfo
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- CN101330840A CN101330840A CNA2006800475682A CN200680047568A CN101330840A CN 101330840 A CN101330840 A CN 101330840A CN A2006800475682 A CNA2006800475682 A CN A2006800475682A CN 200680047568 A CN200680047568 A CN 200680047568A CN 101330840 A CN101330840 A CN 101330840A
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Abstract
本发明提供了用于抑制黄斑变性进展和促进健康视觉并且同时维持总体健康的改良的膳食补充物和方法。本发明的膳食补充物含有维生素E以及维生素A、叶黄素和/或玉米黄质形式的类胡萝卜素类物质。本发明的膳食补充物还含有维生素C、铜和锌,还可含有诸如迷迭香、DHA之类的成分以及其它维生素和矿物质。
Description
背景技术
本申请要求了于2005年12月20日提交的序号为60/751,836的美国临时申请的优先权。
1.技术领域
一般而言,本发明涉及用于缓解眼睛疾病的营养方法和组合物,更具体而言,本发明涉及用于治疗白内障和黄斑变性的改良的方法和组合物。
2.相关现有技术描述
与衰老和出现脉网膜小疣有关的黄斑变性备受关注,因为目前在美国AMD(与年龄相关的黄斑变性)是65岁以上的个体失明的主要原因。而此时恰恰眼睛是最重要的感觉器官,读书和看电视经常是老年人最主要的娱乐途径,这种疾病剥夺了老年患者的该类娱乐可能。
我们知道眼睛的晶状体仅有一种疾病状态,即白内障。随着晶状体变得不透明,其丧失了清晰性,根据不透明的程度,视力受到妨碍。公认的是白内障有不同的病因,如先天性损害或外伤。如同早期发作的代谢错误如半乳糖血症或导致糖尿病的潜伏遗传错误能造成白内障一样,还已知一些药物如可的松类制剂和青光眼用药可造成白内障。但是,与更熟悉的与年龄相关的白内障(其与导致蛋白质交联和沉淀的蓄积性氧化应激有关)相比,这类疾病比较少见。
难以确定一般群体中白内障的准确发病率,因为其部分取决于白内障的自身定义。如果白内障被定义为仅仅是晶状体不透明,则其发病率显然比白内障被定义为显著影响视力的晶状体不透明时的发病率高得多。尚未完全了解与年龄相关的白内障和黄斑变性的发病机理。
脉网膜小疣和脂褐质的蓄积以及视网膜色素的损失是黄斑变性的标志,其似乎是由参与感光和信号处理并且通常被RPE(视网膜色素上皮)解毒、处理和排出的生物活性分子的生物分子衍生物的蓄积造成的。虽然认为控制脂褐质和其主要毒性组分A2E-N-亚视黄基-N-视黄基乙醇胺(其能将可视波长辐射转化成有毒的ROS(活性氧类))的蓄积很重要(Sparrow,2001),但是一直没有提出实现其的手段,目前可用于限制损害的最好手段之一是降低脂褐质可获得的辐射量。除了尝试对在视网膜下形成异常血管(即视网膜下新血管形成)的那些患者进行激光光凝固术以外,迄今为止针对所造成的萎缩或血管生成还没有有效的治疗。患有晚期AMD的可治疗组是大得多的组中的不同少数。预期患此病的个体可能发生进行性恶化或者有时发生相对静止的过程,但是不会自动改善,因为视网膜的基本构造被破坏了。偶尔可见似乎表现出改善的视力变化,其取决于诸如房间的照明和视网膜下流体的潜在分辨率之类的因素。但是重要的是当这种敏感的神经学组织受损时,该损害是永久性的。
在1981年,Spector等人称在晶状体蛋白质的大量氧化中所涉及的机理和物质以及其与白内障发生的关系方面仍然有一些问题(Spector等人1981)。他们还注意到谷胱甘肽(GSH)可用作还原剂和自由基捕获剂。存在代谢H2O2的谷胱甘肽过氧化物酶(GSHPx)和过氧化氢酶。虽然超氧化物歧化酶(SOD)可以解毒O2,但是光可以在光化学上诱导氧化。但是,Spector等人认为虽然还不清楚光和/或代谢诱导的氧化在导致观察到的氧化产物方面的全部机理,但是它们似乎与细胞内氧化剂如过氧化氢的水平升高有关。
在1987年,Machlin等人报道说有一些证据表明,自由基损害促发包括白内障在内的一些疾病的病因(Machlin等人,1987)。他们指出对抗该类自由基损害的防御包括维生素E、维生素C、β胡萝卜素、锌、铁、铜、锰和硒。
在1988年,Jacques等人报道说通常认为氧化机理与白内障的形成因果相关,但不是仅与其相关。根据Jacques等人,有证据表明GSHPx和SOD随着白内障程度的增加而减少。
Jacques等人还报道说认为维生素E是白内障形成的决定因素并且可与GSHPx协同起效以防止氧化损害。他们指出了一种可能,即维生素C可能在白内障形成中起作用并且可能通过其再生维生素E的能力而影响GSHPx。
出于包括改善视力或预防视力降低在内的多种原因,采用一些膳食补充物。可用于促进眼睛健康的一组膳食补充物的实例有膳食补充物(爱尔康公司(Alcon Laboratories,Inc.),Fort Worth,TX)。膳食补充物一般为粉末、片剂、咀嚼片、胶囊、胶囊锭(gelcap)或液体填充的软胶囊(softgel)形式,并且包括多种维生素、矿物质和草药或其它有机组分。一些膳食补充物用小囊粒(beadlets)进行配制。
最新数据表明,在膳食补充物中包括叶黄素类物质和其它类胡萝卜素类物质可提供可用于增强眼睛健康的优良膳食补充物。研究表明,视网膜以约2∶1的黄体素(lutein):玉米黄质比例选择性摄取类胡萝卜素类物质-玉米黄质和黄体素,但是在黄斑中其比例相反(Bernstein等人,1997&2004;Bone和Landrum等人,1988&2001;Krinsky等人,2003;Hammond等人,1997;和Handelman等人,1991)。该早期工作表明既存在黄体素又存在其位置异构体-[R,R]-玉米黄质。近来已经在黄斑中发现了玉米黄质的第二种异构体,即非对映体内消旋玉米黄质-玉米黄质的[R,S]异构体(Bone&Landrum等人,1988)。这些结果和相关的观察结果表明二者对于改善眼健康和黄斑保护而言都是必需的。
叶黄素类物质是有效的植物化学抗氧化剂,已知其位于视网膜斑中。已经表明特定的叶黄素类物质-玉米黄质及其异构体黄体素在维持或改善黄斑的健康和晶状体的透明度方面可能是有益的。这些分子可以以许多方式起作用来保护眼睛免受高强度辐射或其它损伤影响。已经表明中央凹蛋白质结合叶黄素类物质,使叶黄素类物质定位和集中于中央凹内(Bernstein等人,2004)。由于叶黄素类物质能吸收短可见波长的光激发(photoexcitative)辐射,因此它们也可防护神经视网膜和RPE的光敏性底层(underlying)细胞。该类细胞负责高分辨率视觉,流行病学研究已经表明接触高强度辐射或甚至长期接触可见波长辐射都会对其产生不利影响。认为类胡萝卜素类物质能补充这些细胞的活性,并且还可保护其免受光化学损伤影响。参见例如Snodderly(1995)和Seddon等人(1994)。
研究还表明,与叶黄素沉积相关的视网膜部分具有机体中最高的代谢速率之一(Berman 1991)。维持这种代谢的能量源自氧化。虽然亲脂性很高的叶黄素类物质似乎不经历水溶性或表面活性抗氧化剂的迅速翻转特性(Hammond等人,1997),但是作为对环境应激和组织环境的响应发生连续的叶黄素类物质交换,在没有营养代替的情况下它们的逐渐消耗可能是组织损害的前兆(Hammond等人1996a;Hammond等人,1996b;和Seddon等人,1994)。缺乏迅速翻转还牵涉其它协同抗氧化剂-维生素C和E、尤其是在氧化还原级联中有活性的酶抗氧化剂的作用,所述氧化还原级联将最初的氧化刺激传递至能量更低和损害更小的种类。
胡萝卜素类物质是轭合的C40化合物,其包括β-胡萝卜素(一种维生素原,维生素A前体)。胡萝卜素类物质是深色化合物,发现其在植物王国中广泛存在,例如,存在于多叶的蔬菜如菠菜和甘蓝以及颜色鲜亮的水果如甜瓜类和菠萝中。虽然胡萝卜素类物质在植物王国中无处不在,但是它们一般在哺乳动物中不能通过生物合成获得。由于胡萝卜素类物质对于哺乳动物的正常健康而言是必需的,因此哺乳动物需要摄取各种胡萝卜素类物质源,例如水果和蔬菜。已知眼变性疾病与膳食中缺乏类胡萝卜素类物质、尤其是胡萝卜素衍生物-维生素A有关。
维持老年或正在变老的患者的健康的另一种重要因素是确保其摄取适宜量的维生素和矿物质。因为生物吸收能力受损,许多老年或正在变老的患者仅通过膳食不能摄取推荐量的维生素和矿物质。此外,正在变老的患者往往还服用许多处方药。记得每天在适当的时间服用所有处方药对于老年患者而言是一种挑战。添加针对眼健康的复合维生素和另外的膳食补充物会增加每天服药的不依从性的可能。老年和正在变老的群体需要的是能提供每天推荐量的维生素和矿物质、同时能补充针对维持眼健康的推荐水平的另外的维生素、矿物质和必需营养物的单一膳食补充物。
发明概述
本发明通过提供复合维生素膳食补充物而克服了这些缺点和现有技术中的其它缺点,所述复合维生素膳食补充物含有推荐膳食量或更高量的许多对于机体总体健康而言必需的/重要的维生素和矿物质以及维持或改善眼健康所必需的另外的维生素、矿物质和必需营养物的独特组合。
本发明涉及用于维持和改善眼睛和全身健康的改良制剂。具体而言,该改良制剂包含在与年龄相关的眼病研究(AREDS)中证明可减缓AMD进展的特定组合和量的维生素和矿物质以及维持患者总体健康的复合维生素、矿物质和必需营养组分。该类改良制剂还可以以视网膜中存在的比例提供黄体素和玉米黄质。优选的制剂还可含有一种或多种生物类黄酮类物质和提供抗氧化剂功能或信号和控制功能以保护眼组织免受光氧化应激所产生的有害代谢物影响的其它植物营养物(phytonutrients)。
特定组合的成分的优点在于它们基本完全,并且对它们进行选择以消除将多种产品组合时可能发生的成分失衡。此外,还要求保护专门针对不同群体部分的不同类型的膳食补充物,所述不同群体部分可能具有特定的膳食需求或限制。
发明详述
根据本发明,组合物的元素旨在清除自由基和氧化剂或者以其它方式延迟黄斑变性的疾病进展。同时,本发明的制剂提供了老年患者维持总体健康所需的复合维生素组分。本发明主要针对的自由基包括过氧化物和氢氧化物自由基。所述氧化剂主要包括过氧化物。
本发明的物质和剂量与在健康食品商店中容易获得的那些一致。剂型优选为用于口服施用的片剂、胶囊型片剂(caplet)或软胶囊形式,患者一天服用一至四个剂量,服药一次或两次。但是,本发明包括:优选的总剂量可以以单剂量或其它多个部分剂量的形式被施用。组合物也可以是定时释放或延迟释放类型。而且,对于口服施用而言,本发明的组合物可以是按照众所周知的方法制备的胶囊、膜衣片(lacquered tablet)、无膜衣片、软胶囊或者是控释粉末的混合物。根据上述优选的多种剂量,片剂、胶囊形片剂或软胶囊的组成各自优选大约如下:
维生素C
已知的是:在正常的人晶状体中和在围绕着晶状体的房水中都存在高浓度的维生素C,其是抗氧化剂(Harris 1933)。过去还已经证明一般增加膳食维生素C会增加房水中和人晶状体中抗坏血酸盐的浓度(Ringvold1985)。还已知的是:维生素C浓度随着年龄的增加而降低,特别是在患有老年白内障的患者中尤其如此(Chatterjee 1956;Purcell 1968)。随后的工作证明补充维生素C可有效增加这种水溶性抗氧化剂的晶状体浓度,流行病学数据为其在降低白内障患病率方面的价值提供了支持(Taylor,1999)。还已经表明维生素C是将氧还原成水的抗氧化级联必不可少的,所述级联能再生位于生物膜中的还原形式的维生素E。
尽管U.S.RDA是60mg,但是最佳的维生素C日剂量是未知的。然而,常常将2.0克和更高的剂量视为总体健康的补充物。虽然可以使用抗坏血酸或蔷薇果(rose hips),但是本发明的组合物优选利用抗坏血酸钠形式的维生素C,因为其在消化系统中易于溶解并且造成较小的刺激。浓度为约200-250mg/片剂或胶囊形片剂,或者优选的总剂量为约0.8-2克/天。在该类浓度下,维生素C占每个片剂或胶囊形片剂的约20-30%重量,所述片剂或胶囊形片剂包括下述活性及无活性成分。
维生素E
如已经提及的那样,维生素E也是一种众所周知的抗氧化剂(也参见Mansour 1984)。维生素E可以与维生素C协同起作用来保护活细胞功能免受内源性氧化剂的影响(Orten 1982)。
一种十分常见的维生素E补充法由每天400个国际单位所组成。虽然每天使用高于800IU的研究表明可能出现毒性迹象,但是在超市中可获得的许多常见膳食补充物具有1000个单位的维生素E日剂量(例如,Chaney1986)。U.S.RDA为30IU。本发明优选使用醋酸d,l-α生育酚形式的维生素E,1mg该物质相当于1个IU。优选浓度为每个片剂或胶囊形片剂约15IU-400IU维生素E或总日剂量为30-800IU维生素E。其占每个片剂或胶囊形片剂的约1%至优选低于20%重量。
锌
已知对于视网膜健康和维生素A的功能而言锌都很重要(Russell 1983;Karcioglu 1982;Leure-duPree 1982)。锌是维持叶酸盐的生物利用度所需酶的辅因子(Chandler等人,1986),叶酸盐对于健康DNA和蛋白质合成而言都是很重要的。锌是一种以前在研究中使用的补充物,该研究表明在延迟黄斑变性变化方面锌显著优于安慰剂(Newsome 1988)。还已知锌是许多金属酶的重要辅因子,其中不仅仅包括超氧化物歧化酶,其清除强氧化剂-过氧化物。在哺乳动物细胞中有两类SOD。一类包含铜和锌,位于线粒体的胞质溶胶和周质间隙中。另一类包含锰,位于线粒体的基质中(一般性地参见美国专利4,657,928)。线粒体是神经视网膜和视网膜色素上皮(RPE)中高代谢活性和迅速氧化过程的部位,提供将可见光辐射刺激转化成化学信号所需的能量。SOD的这些同种型和锌也与白内障有关,因为与非白内障患者相比白内障患者体内超氧化物歧化酶活性和锌都显著降低(Ohrloff 1984;Varma 1977;Swanson 1971)。在与维生素A代谢(调节酯化水平)有关的酶中也包括锌。通过这些方式,锌参与调节视黄醇的肝储存、释放和运输,从而调节其对眼组织的生物利用度(Russell 1983)。
虽然每天约200mg锌耐受性良好,但是已经表明其可能有副作用,特别是阻断铜吸收,这会导致缺铜性贫血(copper deficiency anemia)(Fischer1983)。还表明高剂量的锌具有降低高密度脂蛋白血清滴度的作用,从而可能加剧动脉粥样硬化的风险(Hooper 1980)。
过去已知每天100-150mg的锌剂量可毫无困难地被良好耐受(Wagner1985)。U.S.RDA为15mg。虽然可以使用其它盐形式如硫酸盐、吡啶甲酸盐、磷酸盐和葡糖酸盐,但因为醋酸锌的生物利用度高,本发明优选以醋酸锌的形式提供锌,并且因为氧化锌的锌密度高,优选以氧化锌的形式提供锌。优选的日剂量范围为RDA至最多约100mg生物可利用形式的锌,如醋酸锌。生物利用度较低形式如氧化锌形式的锌的最大量可高达150mg/天。任何一种形式都可以以片剂、胶囊形片剂、粉末或软胶囊的形式施用。
铜
铜是金属酶的另一种重要辅因子,是超氧化物歧化酶的第二种必需辅因子(Beem 1974)。已经表明:在70岁以上的个体体内铜减少,在白内障晶状体中铜基本为零(Swanson 1971)。如果铜显著减少,已经表明超氧化物歧化酶功能下降,从而妨碍一种保护晶状体的重要机理(Williams 1977)。铜还对锌毒性具有保护作用,其阻断一些锌吸收并且因此降低其生物利用度(Van Campen 1970)。
已经估计每天2至3mg铜是安全的,可提供足够的每日膳食摄入量(Pennington 1986)。U.S.RDA是日剂量2mg。一些铜吸收将被如上所提供的每日100mg锌阻断(Van Campen 1970)。因此,本发明的组合物优选提供约1-5mg/天。认为该量是安全的,因为在通常的美国膳食中,特别是在老年人的膳食中,锌和铜经常大大低于最小每日需求量。在本发明的该实施方案中,铜优选以葡糖酸铜、柠檬酸铜或氨基酸螯合物的形式被提供,对于通常每日施用两次的补充物如黄体素和玉米黄质配方产品而言,该类形式的铜通常占每片片剂或胶囊形片剂的小于约3%重量,对于通常每日施用四次的补充物如AREDS而言,通常占小于1%重量。在剂型中的可用总空间十分有限的情况下,还已经用氧化铜作为补充物中的铜源,因为在该化合物中铜的分数更高。
β-胡萝卜素
众所周知,维生素A是视觉必需的。维生素A(即视黄醇)是一种C20烯烃,其以视黄醛形式与视网膜中的视蛋白结合从而形成视紫红质,其是一种视色素。光刺激导致视黄醛从顺式形式转化成反式形式。因此,显然维生素A对于感光而言很关键。β-胡萝卜素是一种维生素原A类胡萝卜素,其是一种脂溶性的橙色色素,可用作视黄醛的自调节源。由于维生素A不仅与视觉有关,而且与生长、再生、细胞增殖、细胞分化和适当免疫功能有关,因此视黄醇的不足和过量均能导致胎儿畸形。
被转化成视黄醇的β-胡萝卜素的量在生物学上受视黄醇需求的控制和指挥。通过C40-类胡萝卜素中心对称酶裂解成C20-类视色素来发挥控制作用。因此,没有观察到β-胡萝卜素有任何类型的维生素A毒性。但是令人吃惊的是,还是发现了明确的β-胡萝卜素毒性。虽然对β-胡萝卜素不足的治疗降低了食管癌和胃癌的发生率,但是在以高日剂量(即,30mg/天)的β-胡萝卜素治疗吸烟者的肺癌和心血管疾病时观察到了与其使用有关的外源物(xenobiotic)处理受损。结果,鼓励吸烟者(AMD高危人群)不要将其β-胡萝卜素补充水平增加至RDA水平以上。这种建议与由7-年ARED研究所获得的建议直接矛盾,在所述研究中约17-24mg/天被消耗(AREDSResearch Group 2002)。
如下所述,对这些相互矛盾的建议的一个解决办法是提供一种完全制剂,其包括ARED研究中三分之二的受试者所消耗的复合维生素中的维生素和矿物质,将类胡萝卜素类物质总量维持在15mg或更低的指定水平上。在一个制剂中,用黄体素和玉米黄质代替一部分β-胡萝卜素,从而将β-胡萝卜素的日剂量维持在RDA,即3mg/天。在另一个实施方案中,用黄体素和玉米黄质完全代替β-胡萝卜素。每片的量将取决于针对特定剂型所推荐的片剂数,一般为每天2-4片。
叶黄素类物质
虽然叶黄素类物质也是C40化合物和是类胡萝卜素类物质,但是该小类以存在更多极性基团而著称。黄体素和玉米黄质异构体在两个芷香酮末端环上均具有醇性羟基,这对这些类胡萝卜素类物质的定位和应用发挥很大作用。对这些脂类具有特异性的结合蛋白质似乎控制其在眼睛中的定位,既控制其总绝对量,又控制其相对量。例如,在灵长类动物和人(例如尸体的眼睛)中观察到的结果表明,虽然黄体素是眼睛中最丰富的叶黄素,但是在中央凹附近玉米黄质的相对量高于黄体素。叶黄素类物质均可作为抗氧化剂、自由基猝灭剂和蓝光吸收剂,并且所有这些功能都是这些分子对视网膜底层及其支撑组织-RPE的保护功能。这些叶黄素类物质彼此均是异构体;玉米黄质类物质在轭合序列中具有一个另外的双键,因此黄体素和玉米黄质是位置异构体。两个玉米黄质异构体-3,3′-[R,R]和3,3′-[R,S](内消旋形式)是非对映体,仅在一个光学中心上有差异。已经观察到在黄斑中存在所有这三种二醇类物质。
通常认为叶黄素类物质是十分安全的化合物,存在于从甜瓜类至玉米至菠菜和甘蓝等可食用植物和蔬菜中。流行病学已经表明,消耗较高的四分位值和五分位值(higer quartiles and quintiles)的量的那些个体AMD的发生率较低。已经将GRAS状态归因于游离醇和酯形式的黄体素和游离醇形式的玉米黄质。黄体素显然与玉米黄质的内消旋形式可相互转化,但是仍然没有确定负责该相互转化的蛋白质,因此控制该相互转化的精确机理和手段仍然是未知的。结果,这些叶黄素类物质在膳食和补充物中的一定平衡似乎是最明智的。
流行病学和前瞻性临床研究均表明叶黄素类物质的较高黄斑水平可保护视网膜免受氧化应激影响。一些数据为中年和老年的缺陷增加提供了支持。从流行病学数据看出,高于6mg/天的叶黄素类物质水平在延迟AMD发作方面是有益的。关于膳食对生物利用度的影响的研究表明在约四至八周内叶黄素类物质的血清水平增加,黄斑色素水平的响应更慢,但是一般在四至六个月内就会发生响应,这可能与受治疗者的年龄、性别和其它健康和风险因素有关。这些数据还表明,增加速率和平台水平均取决于日摄取量以及其它个体因素。美国健康与营养调查(The National Health andNutrition Examination Survey)(NHANES)水平,即正常的美国国内摄取量为约2mg/天。因此,在本发明的方法和组合物中,叶黄素类物质的每日总补充量优选为2mg/天至18mg/天,更优选低于约16mg/天。
已经表明在视网膜中黄体素∶玉米黄质的比例为约2∶1。认为在膳食补充物中提供类似比例的黄体素∶纯化玉米黄质比提供高得多的量的黄体素(例如在植物源中可能天然存在的该化合物量)可更有效地维持眼健康。因此,在本发明的优选方面,黄体素和玉米黄质将以2∶1的比例存在于制剂中。例如,如果在制剂中存在4mg黄体素,则在制剂中将存在2mg玉米黄质。同样,8mg黄体素对应于4mg玉米黄质等。
本发明涉及用于维持患者或消费者的总体健康和眼健康的改良膳食补充物制剂。本文所用的“膳食补充物”或简短形式“补充物”是指含有膳食物质并且适于被主体例如人或其它哺乳动物摄入的任何成品膳食补充物剂型。因此,术语“膳食补充物”包括任何形式的膳食补充物,如片剂、咀嚼片、胶囊形片剂、胶囊锭、粉末、软胶囊等。
本文所用的“叶黄素类物质”是指羟基-和酮基-氧化的胡萝卜素类物质及其衍生物,包括游离醇和酯;“胡萝卜素类物质”是指任何40个碳的胡萝卜素类物质及其衍生物;“类视色素类物质”是指20个碳的维生素A(视黄醇)及其衍生物;“类胡萝卜素类物质”是指任何叶黄素类物质、胡萝卜素类物质和类视色素类物质或其组合。类胡萝卜素类物质可以经合成衍生获得或者由天然来源中纯化获得。合成的制备物可含有与天然制备物中所含有的异构体不同的类胡萝卜素类物质的异构体。根据预期用途,在本发明中可包括油状物、饼状物、被包封的油状物或混合物或者整体复合小囊粒(monolithic cobeadlets)形式的合成类胡萝卜素类物质、天然类胡萝卜素类物质或这两种类型的混合物。
叶黄素组分可以得自各种来源如蔬菜和草药组分,如玉米、多叶的绿色蔬菜和金盏草属植物(marigolds);海洋来源,如磷虾;或者微生物来源,如藻类和基因工程细菌或酵母来源。叶黄素类物质还可以用本领域中已知的方法合成和由许多制造商出获得。叶黄素类物质的实例包括但不限于黄体素、玉米黄质、虾青素、角黄素、隐黄素和相关的含油树脂类(oleoresins)(例如叶黄素类物质的脂肪酸单酯和二酯)。各种商业来源中叶黄素的纯度和浓度有所不同。例如,一些来源可提供油形式的约1%重量/重量(“w/w”)或更低的叶黄素,而其它一些来源例如珂敏公司(KeminLaboratories,Inc.)(Des Moines,Iowa)可提供一种油形式的超过20%w/w叶黄素的来源或者结晶或半结晶‘饼状物’形式的高至50%的叶黄素的来源。叶黄素来源可以是各叶黄素类物质的制备物或其组合,并且浓度可根据稀释度而变化,或者实际上它们不存在,因为一些粉末或‘饼状物’制备物可提供更优选的原料。例如,叶黄素制备物可包含黄体素作为唯一的叶黄素或者包含黄体素和玉米黄质的组合,包括玉米黄质非对映体([R,R′],[R,S],[S,R]和[S,S])的组合,其中优选的组合包括黄体素、[R,R′]-玉米黄质和内消旋-玉米黄质的混合物。其它优选的组合包括[R,R′]-玉米黄质和内消旋-玉米黄质的混合物和/或黄体素和任何一种玉米黄质非对映体的混合物。当希望将该类组合尤其以与视网膜中广泛发现的或者在眼睛的黄斑或中央凹中发现的那些比例类似的比例或者以摄入时支持主体组织中的比例的其它比例递送给主体时,在制剂中包括和以特定比例包括叶黄素类物质的组合是特别重要的。叶黄素类物质还可以以轭合衍生物例如上面所例举的叶黄素类物质的含油树脂的形式被包括在制剂中。
ω-3脂肪酸
天然存在的且在冷水鱼组织中很丰富的ω-3脂肪酸在人视网膜光感受器的视神经盘中也很丰富。在流行病学上,已经发现膳食中匮乏ω-3脂肪酸的个体的AMD患病率较高,即,膳食中ω-3的量与AMD的患病率反向相关(Seddon和Willett等人)。在眼睛健康中很重要的两种主要的ω-3脂肪酸-轭合的脂肪酸-是DHA(二十二碳六烯酸)和EPA(二十碳五烯酸)。本文所用的术语“DHA”是指这两种主要ω-3脂肪酸中的任何一种或者二者的混合物;即,当使用术语“DHA”时,本领域技术人员应当理解在该种情况中可使用DHA、EPA或者EPA与DHA的混合物。当使用混合物时,EPA与DHA的优选比例为0.8∶0.2至0.2∶0.8EPA∶DHA。虽然二十二碳六烯酸可由发酵和生物技术来源制得,但是优选的混合物通常是由鱼获得的,然后进行纯化/除臭。
用于全身健康的其它维生素/矿物质
维生素:
维生素D是钙内环境稳定的主要调节剂,对于正常的骨、肌肉和神经的生长和功能而言是必需的。已经表明维生素D可对抗骨质疏松,在体内具有抗癌和抗氧化剂活性。已经确定维生素D的RDI为400IU/天。
维生素K作为辅因子参与调节适当凝血所必需的止血蛋白质,从而预防过度出血。已经确定维生素K的RDI为80μg/天。
硫胺(维生素B1)是利用碳水化合物和脂肪以产生能量和支持细胞代谢所必需的。硫胺在神经肌肉发育和维持中是重要的。已经表明维生素B1在包括脑在内的神经组织中具有抗氧化剂作用。已经确定硫胺的RDI为1.5mg/天。
核黄素(维生素B2)在维持能量产生和涉及碳水化合物、脂肪和蛋白质的代谢过程中以及对于正常细胞功能和生长而言都是很重要的。核黄素可帮助保持健康的眼睛、神经和皮肤功能。已经确定核黄素的RDI为1.7mg/天。
烟酸(维生素B3)参与许多生物化学反应,包括能量产生以及脂肪和类固醇合成。已经发现维生素B3降低血清胆固醇、低密度脂蛋白(LDL)、极低密度脂蛋白(VLDL)和甘油三酯类的总水平。烟酸不足可导致皮炎、GI道炎症,是色氨酸不足的结果。已经确定烟酸的RDI为20mg/天。
泛酸(维生素B5)是人营养所必需的以实现适当的能量产生、脂肪酸、类固醇、胆固醇和氨基酸合成和分解,并且可作为抗氧化剂发挥作用。辅酶A(在氧化磷酸化中很重要)和酰基载体蛋白(泛酸合并入其中)的多种功能已经被充分认识到。已经确定泛酸的RDI为10mg/天。
吡哆醇(维生素B6)在蛋白、脂肪和碳水化合物的体内代谢中很重要。已经发现补充维生素B6可降低高血压患者的收缩压和舒张压、保护血管内皮细胞对抗血小板诱导的损害和提供保护以对抗动脉粥样硬化。已知吡哆醇是形成血红蛋白所必需的并且对于储存葡萄糖的利用而言很重要。已经确定吡哆醇的RDI为2mg/天。
维生素B12是一种含钴的酶辅因子,其特别是红细胞发育中正常细胞生长和发育所必需的,并且提供保护对抗体内的神经变性病症,尤其是老年人的该类病症。素食者容易出现维生素B12缺乏。维生素B12摄入不足可促发贫血。维生素B12可降低动脉粥样硬化的风险。已经确定维生素B12的RDI为6μg/天。
叶酸(一种B族维生素,有时被称为维生素B9)对于适当的细胞生长和发育以及预防神经先天缺陷而言是必需的。叶酸不足可导致贫血和白细胞不足,白细胞在对抗感染性疾病中起重要作用。已经表明叶酸具有防癌(anticarcinogenic)作用并且在预防心血管疾病、尤其是老年人的心血管疾病中发挥作用。叶酸盐摄入量不足可促发贫血。叶酸盐水平低是半胱氨酸水平升高以及遗传异常(一种SNP,单核苷酸突变)-重要的动脉粥样硬化风险因子-的一种决定因素。已经确定叶酸盐的RDI为400μg/天。
生物素(一种B族维生素,有时被称为维生素H)是参与脂肪和碳水化合物的生物合成以及氨基酸的代谢的酶辅因子,这部分是由于其固定CO2的功能。已经发现补充生物素可改善葡萄糖耐受性和降低胰岛素抗性。已经确定生物素的RDI为300μg/天。
植物性药(Botanicals):
番茄红素是一种具有强抗氧化剂活性的类胡萝卜素,其保护细胞对抗氧基和光损害。研究表明番茄红素可提供保护对抗前列腺癌和冠心病。迄今为止,还没有确定番茄红素的RDI。
迷迭香是一种草药,其含有生物类黄酮类物质和强抗氧化剂的混合物,所述抗氧化剂包括鼠尾草酚和鼠尾草酸(carnosic acid)。没有确定迷迭香生物类黄酮类物质的RDI,并且哺乳动物不能生物合成这些抗氧化剂。
矿物质:
钙是维持骨健康和细胞调节所必需的。已经将补充钙与降低高血压患者的血压以及降低人的血清胆固醇水平相关联。已经确定钙的RDI为1000mg/天。
铬是帮助调节血糖所必需的微量元素,其与胰岛素一起起作用将葡萄糖运送到细胞中。铬与胰岛素一起起作用将碳水化合物和脂肪转化成能量。已经确定铬的RDI为120μg/天。
碘是对甲状腺功能至关重要的必需微量元素。碘是甲状腺激素类的重要组分,其对正常发育和控制代谢速率而言都很重要。已经确定碘的RDI为150μg/天。
镁是ATP产生和钙调节所必需的重要矿物质。补充镁可能在体内具有抗高血压、葡萄糖调节和心脏保护作用。镁是健康的神经和肌肉功能以及骨形成所必需的,并且影响神经肌肉协调。镁可帮助预防冠心病。已经确定镁的RDI为400mg/天。
锰是在一些对正常细胞代谢很重要的关键酶中发现的必需的微量元素,可帮助维持对抗氧化损害的保护、控制活性氧类的水平和损害。葡萄糖利用、软骨粘多糖合成以及类固醇生物合成需要锰。已经确定锰的RDI为2mg/天。
钼是神经系统和眼睛健康以及处理体内可能有害的许多化学物质所需的重要微量元素,已知其在黄嘌呤氧化酶中作为酶辅因子发挥作用,在嘌呤碱的代谢中也很重要。已经确定钼的RDI为75μg/天。
三价磷是一种重要矿物质,其是DNA、细胞膜以及细胞内能量产生和储存的重要组分。三价磷与钙协作对于骨和牙齿的构建和硬化而言很重要。已经确定三价磷的RDI为1000mg/天。
钾是维持细胞内张力和正常血压的重要矿物质,在体内神经信号传导中起主要作用。研究表明补充钾可提供保护对抗中风、心血管疾病和其它变性疾病。已经确定钾的DRV为3500mg/天。
硒是与微生物C和E一起起作用以提供保护对抗细胞中的氧化损害的重要微量元素,特别是硒维持肝组织的健康。硒促进细胞神经生长和发育以及心脏健康。作为酶辅因子,硒对于心肌的健康功能而言是必需的。已经确定硒的RDI为70μg/天。
其它考虑
组分胡萝卜素、类视色素或其组合(在下文被称为“胡萝卜素(类物质)/类视色素(类物质)”)可得自多种来源如蔬菜和草药来源如玉米和多叶蔬菜以及可由生物技术工业获得的发酵产品来源。胡萝卜素类物质/类视色素类物质还可用本领域中已知的方法合成。胡萝卜素类物质的实例包括但不限于α-、β-、γ-、δ-、ε-和χ-胡萝卜素及其异构体。类视色素类物质的实例包括但不限于维生素A和维生素A类似物(例如视黄酸)。各种商业来源中的胡萝卜素/类视色素纯度和浓度可有所不同。例如,一些来源可提供油状物形式或油混悬液形式或被保护的干燥形式例如复合小囊粒(cobeadlet)形式的约1%w/w或更低的胡萝卜素/类视色素。
制剂中叶黄素类物质和胡萝卜素类物质/类视色素类物质的浓度将有所不同,但是将是可用于膳食补充物中的量。一般而言,制剂中叶黄素类物质和胡萝卜素类物质/类视色素类物质的联合浓度为约0.1至10%w/w。优选的类胡萝卜素浓度(其一般取决于所选择的特定胡萝卜素类物质/类视色素类物质和叶黄素类物质以及它们的相对比例)为约0.5至7%w/w。叶黄素类物质和胡萝卜素类物质/类视色素类物质各自的浓度不一定相同。用于不吸烟的一般人群的优选制剂的浓度比例为约1∶10至约10∶1叶黄素类物质:胡萝卜素类物质/类视色素类物质,最优选的制剂的浓度比例为约2∶1至约1∶2叶黄素类物质:胡萝卜素类物质/类视色素类物质。用于吸烟群体的优选制剂可包含0%β-胡萝卜素至RDAβ-胡萝卜素。
本发明最优选的制剂包括实施例1-4中的那些。
如上所述,制剂还可含有一种或多种另外的抗氧化剂。该抗氧化剂可以是疏水的或亲水的。所述抗氧化剂用于抑制类胡萝卜素组分的氧化、光化学和/或热降解。由于认为抗氧化剂也可用于营养健康,因此它们也可为主体提供一些营养益处。一般而言,所述抗氧化剂可以是天然抗氧化剂或由其衍生获得的物质。天然抗氧化剂以及相关衍生物的实例包括但不限于:维生素E及相关的衍生物,如生育三烯酚类(tocotrienols)、α-、β-、γ-、δ-和ε-生育酚以及它们的衍生物,如相应的醋酸酯、琥珀酸酯;维生素C及相关的衍生物,例如棕榈酸抗坏血酸酯;和天然油类,如迷迭香油。优选的制剂含有一种或多种疏水性抗氧化剂。制剂中所含的抗氧化剂的量为可有效抑制或减少类胡萝卜素组分的氧化、光化学和/或热降解的量。该量在本文中被称为“一种或多种抗氧化剂的有效量”。一般而言,该量为叶黄素和胡萝卜素/类视色素组分和存在的任何其它化学敏感性组分例如生物类黄酮类物质的量的约0.1至10倍。优选的制剂(其一般仅包含约0.5-25%w/w类胡萝卜素类物质,或者包含生物类黄酮类物质)含有约2至10%w/w抗氧化剂。抗氧化剂可与指定营养物合并在小囊粒的离散储库中,然后掺入到剂型中。小囊粒如在美国专利6,582,721和6,716,447以及美国专利申请No.2005/0106272和2005/0147698中所述的那些均可用于本发明的制剂,所有这些专利或专利申请均引入本文作为参考。
制剂还可含有一种或多种固化剂、增量剂(bulking agent)和凝结剂(在本文中被统称为“固化剂”)。固化剂可用于压片和产生固体样载体如小囊粒,所述载体能将油类转化成稳定聚集物以适合于压片所需的制粒、混合和压制。可用于制备本发明的制剂的固化剂的实例包括但不限于蔗糖、葡萄糖、果糖、淀粉类(例如玉米淀粉)、糖浆(例如玉米糖浆)以及离子和非离子聚合物(包括但不限于PEG类和其它聚醚样烷氧基纤维素(HPMC))、胶凝糖(gellan)、角叉菜胶类、琼枝麒麟菜多糖(Eucheuma gelatenae)、瓜尔胶、透明质酸盐、藻酸盐、硫酸软骨素、果胶类和蛋白质类(例如胶原或其水解产物(例如明胶或多肽))。在本发明制剂的制备中还可以使用膳食补充物制备领域的技术人员已知的其它固化剂。固化剂的量将根据制剂中所含的其它组分而变化,但是一般占膳食补充物的大部分重量和体积。
本发明的制剂还可任选地含有一种或多种生物类黄酮类物质和/或糖基化的生物类黄酮类物质。生物类黄酮类物质或“黄酮类化合物”是主要在水果和植物中发现的黄酮-和异黄酮-样结构。生物类黄酮类物质可商购获得或者可以用本领域中已知的方法合成。生物类黄酮类物质的实例包括但不限于槲皮素、金合欢素、甘草黄苷、芸香苷、黄杉素、蜜橘黄素、红橘素、芹黄素、白杨黄素(chyrsin)、杨梅黄酮、染料木素、大豆黄素、木犀草素、柚苷配基和莰非醇以及它们的衍生物,如相应的甲氧基取代的类似物。生物类黄酮类物质可在营养健康中用作体内酶介导的反应速率的调节剂。生物类黄酮类物质还可以提供抗氧化剂活性并且可以为此目的被包含在制剂中。
在本发明的制剂中可以存在其它油类。制剂通常包含一定量的植物油或含油树脂,因为被加入制剂中的单独的胡萝卜素/类视色素和/或叶黄素组分一般以稀植物油或油混悬液的形式或者以含油树脂提取物的形式可商购获得。该油/含油树脂的量通常为制剂中叶黄素或胡萝卜素含量的约1至100倍。例如,膳食补充物中包含的叶黄素提取物可含有20%w/w黄体素、2%w/w玉米黄质和78%植物油/含油树脂。在制剂中还可以包含其它油类。
本发明的制剂还可包含可用于制备和完成膳食补充物的其它赋形剂。该类赋形剂可包括可用于延长该制剂在消化道中的溶出的定时释放聚合物包衣剂。该类聚合物的实例包括但不限于离子和非离子聚合物如PEG类和其它聚醚样烷氧基纤维素类(HPMC)、胶凝糖、角叉菜胶类、琼枝麒麟菜多糖、淀粉、透明质酸盐、硫酸软骨素、果胶类和蛋白质类,例如胶原。因为叶黄素/胡萝卜素类物质是颜色很深,因此可对膳食补充物应用包衣技术以提供颜色均匀的膳食补充物。彩色包衣剂的实例可包括但不限于聚合物、着色剂、隔离剂(sealant)和表面活性剂,包括但不限于脂肪酸类和酯类、甘油二-和三酯类、磷脂类,包括单-和二-烷基甘油基磷酸酯、非离子物质(糖类、多糖类,例如HPMC和聚山梨酯80)和离子物质。
在一些情况中,制剂中所含的上述成分可在膳食补充物内形成微球。膳食补充物可以是各种大小和形状。
膳食补充物可以用本领域中已知的多种技术来制备。本文所述的成分优选以当每天摄入推荐数目的膳食补充物时足以提供日剂量(每天消耗的量)的量存在于本发明的膳食补充物中。但是,重要的是本文所述的膳食补充物至少含有所述量的维生素C、维生素E、黄体素、玉米黄质、铜和锌。在本发明优选的膳食补充物中,可以存在或不存在β-胡萝卜素。
在一些剂型如软胶囊中,需要使用营养物的浓油相。可以将其合并到复合可流动芯中,同时借助常规稀释剂和抗氧化剂对其进行保护。
用下面的实施例来示范本发明的优选实施方案。本领域技术人员应当意识到:下面实施例中所公开的技术代表了本发明的发明人所发现的在本发明的实施中非常有效的技术,因此可认为其构成了实施本发明的优选方式。但是,基于本发明的公开内容本领域技术人员应当意识到可以在不脱离本发明主旨和范围的情况下对所公开的具体实施方案进行许多变化而仍然获得同样或相似的结果。
实施例1
成分 | 量(每个片剂、胶囊、软胶囊等)@QID |
β胡萝卜素 | 0mg |
黄体素 | 1.67mg |
玉米黄质 | 0.83mg |
维生素C | 128mg |
维生素E | 107.5IU |
铜 | 0.9mg |
锌 | 21.15mg |
维生素D | 100IU |
维生素K | 6.25μg |
维生素B1(硫胺) | 0.375mg |
维生素B2(核黄素) | 2.5mg |
维生素B3(烟酸) | 2.5mg |
维生素B6 | 0.5mg |
叶酸盐/叶酸 | 100μg |
维生素B-12 | 1.5μg |
生物素 | 7.5μg |
泛酸 | 2.5mg |
磷 | 35mg |
碘 | 37.5μg |
钙 | 84mg |
镁 | 25mg |
硒 | 10μg |
锰 | 0.5mg |
铬 | 30μg |
钼 | 18.75μg |
钾 | 20mg |
番茄红素 | 0.075mg |
DHA | <25mg |
迷迭香 | >1mg |
水 | TBD |
实施例2
成分 | 量(每个片剂、胶囊、软胶囊等)@QID |
β胡萝卜素 | 0.75mg |
黄体素 | 1.67mg |
玉米黄质 | 0.83mg |
维生素C | 128mg |
维生素E | 107.5IU |
铜 | 0.9mg |
锌 | 21.15mg |
维生素D | 100IU |
维生素K | 6.25μg |
维生素B1(硫胺) | 0.375mg |
维生素B2(核黄素) | 2.5mg |
维生素B3(烟酸) | 2.5mg |
维生素B6 | 0.5mg |
叶酸盐/叶酸 | 100μg |
维生素B-12 | 1.5μg |
生物素 | 7.5μg |
泛酸 | 2.5mg |
磷 | 35mg |
碘 | 37.5μg |
钙 | 84mg |
镁 | 25mg |
硒 | 10μg |
锰 | 0.5mg |
铬 | 30μg |
钼 | 18.75μg |
钾 | 20mg |
番茄红素 | 0.075mg |
DHA | <25mg |
迷迭香 | >1mg |
水 | TBD |
实施例3
成分 | 量(每个片剂)@QID |
β胡萝卜素 | 0.75mg |
黄体素 | 2mg |
玉米黄质 | 1mg |
维生素C | 125mg |
维生素E | 100IU |
铜 | 0.4mg |
锌 | 20mg |
维生素D | 100IU |
维生素K | 6.25μg |
维生素B1(硫胺) | 0.375mg |
维生素B2(核黄素) | 2.5mg |
维生素B3(烟酸) | 5mg |
维生素B6 | 0.5mg |
叶酸盐/叶酸 | 100μg |
维生素B-12 | 1.5μg |
生物素 | 7.5μg |
泛酸 | 2.5mg |
磷 | 27.25mg |
碘 | 37.5μg |
镁 | 25mg |
硒 | 17.5μg |
钙 | 84mg |
锰 | 0.5mg |
铬 | 30μg |
钼 | 18.75μg |
钾 | 20mg |
番茄红素 | 0.075mg |
DHA | <25mg |
迷迭香 | >1mg |
水 | TBD |
下面的实施例、即实施例4表明,观察结果可推荐一种玉米黄质的不同异构体的组合,即不全是一种或另一种。或者,在实施例3中,可以恰当推断将“玉米黄质”解释成代表从0至无限大(即全部为一种或另一种)的玉米黄质类物质比例。在其它组的实施例中可以进行相同推断。
实施例4
成分 | 量(每个片剂)@QID |
β胡萝卜素 | 0.75mg |
黄体素 | 2mg |
[R,R]-玉米黄质 | 0.5mg |
[R,S]-玉米黄质 | 0.5mg |
维生素C | 125mg |
维生素E | 100IU |
铜 | 0.4mg |
锌 | 20mg |
维生素D | 100IU |
维生素K | 6.25μg |
维生素B1(硫胺) | 0.5mg |
维生素B2(核黄素) | 2.5mg |
维生素B3(烟酸) | 5mg |
维生素B6 | 0.5mg |
叶酸盐/叶酸 | 100μg |
维生素B-12 | 1.5μg |
生物素 | 7.5μg |
泛酸 | 2.5mg |
磷 | 25mg |
碘 | 37.5μg |
镁 | 25mg |
硒 | 10μg |
钙 | 84mg |
锰 | 0.5mg |
铬 | 30μg |
钼 | 18.75μg |
钾 | 20mg |
番茄红素 | 0.075mg |
DHA | <25mg |
迷迭香 | >1mg |
水 | TBD |
下面的实施例、即实施例5提供了用于具有低血清或色素水平的个体或者可能对补充响应较小的个体的更高浓度的类胡萝卜素类物质
实施例5
成分 | 量(每个片剂)@QID |
β胡萝卜素 | 0.75mg |
黄体素 | 3.32mg |
玉米黄质 | 1.67mg |
维生素C | 125mg |
维生素E | 100IU |
铜 | 0.4mg |
锌 | 20mg |
维生素D | 100IU |
维生素K | 6.25μg |
维生素B1(硫胺) | 0.5mg |
维生素B2(核黄素) | 2.5mg |
维生素B3(烟酸) | 5mg |
维生素B6 | 0.5mg |
叶酸盐/叶酸 | 100μg |
维生素B-12 | 1.5μg |
生物素 | 7.5μg |
泛酸 | 2.5mg |
磷 | 25mg |
碘 | 37.5μg |
镁 | 25mg |
硒 | 10μg |
钙 | 84mg |
锰 | 0.5mg |
铬 | 30μg |
钼 | 18.75μg |
钾 | 20mg |
番茄红素 | 0.075mg |
DHA | <25mg |
迷迭香 | >1mg |
水 | TBD |
实施例6的组合物描述了用于要维持眼健康、但是服用大片剂(或其它剂型)没有困难的个体的有意义的制剂。实施例6的组合物和给药方案对于该类患者的每日膳食补充需要而言是适宜和充分的。
实施例6
成分 | 量(每个片剂)@BID |
β胡萝卜素 | 1.5mg |
黄体素 | 2mg |
玉米黄质 | 1mg |
维生素C | 200mg |
维生素E | 75IU |
铜 | 0.5mg |
锌 | 20mg |
维生素D | 200IU |
维生素K | 12.5μg |
维生素B1(硫胺) | 0.751mg |
维生素B2(核黄素) | 5.0mg |
维生素B3(烟酸) | 10mg |
维生素B6 | 1mg |
叶酸盐/叶酸 | 200μg |
维生素B-12 | 3.0μg |
生物素 | 15μg |
泛酸 | 5mg |
磷 | 70mg |
碘 | 75μg |
钙 | 168mg |
镁 | 50mg |
硒 | 35μg |
锰 | 1mg |
铬 | 60μg |
钼 | 37.5μg |
钾 | 40mg |
番茄红素 | 0.150mg |
DHA | <50mg |
迷迭香 | >1mg |
水 | TBD |
与实施例6的组合物一样,实施例7的组合物描述了一种用于要维持眼健康、但是因为其血清或色素水平低因此需要更高水平的类胡萝卜素类物质的个体的有意义的制剂。实施例7的组合物和给药方案对于该类患者的每日补充需要而言是适宜和充分的。
实施例7
成分 | 量(每个片剂)@BID |
β胡萝卜素 | 1.5mg |
黄体素 | 6.7mg |
玉米黄质 | 3.3mg |
维生素C | 200mg |
维生素E | 100IU |
铜 | 0.5mg |
锌 | 20mg |
维生素D | 200IU |
维生素K | 12.5μg |
维生素B1(硫胺) | 0.751mg |
维生素B2(核黄素) | 5.0mg |
维生素B3(烟酸) | 10mg |
维生素B6 | 1mg |
叶酸盐/叶酸 | 200μg |
维生素B-12 | 3.0μg |
生物素 | 15μg |
泛酸 | 5mg |
磷 | 70mg |
碘 | 75μg |
钙 | 168mg |
镁 | 50mg |
硒 | 35μg |
锰 | 1mg |
铬 | 60μg |
钼 | 37.5μg |
钾 | 40mg |
番茄红素 | 0.150mg |
DHA | <50mg |
迷迭香 | >1mg |
水 | TBD |
实施例8的组合物描述了一种用于要维持眼健康、但其膳食不需要补充复合维生素的个体的有意义的制剂。实施例6的组合物和给药方案对于该类患者的每日补充需要而言是适宜和充分的。
实施例8
成分 | 量(每个片剂)@BID |
β胡萝卜素 | 1.5mg |
黄体素 | 3.3mg |
玉米黄质 | 1.7mg |
维生素C | 200mg |
维生素E | 75IU |
铜 | 0.5mg |
锌 | 20mg |
维生素B2(核黄素) | 5.0mg |
叶酸盐/叶酸 | 100μg |
维生素B-12 | 3.0μg |
硒 | 20μg |
锰 | 5.0mg |
番茄红素 | 0.075mg |
DHA | 12.5mg |
迷迭香 | >1mg |
水 | TBD |
实施例9的组合物描述了一种用于要维持眼健康、但对叶黄素类物质具有更高需求的个体的有意义的制剂。这种组合物和给药方案对于该类患者的每日补充需要而言是适宜和充分的。
实施例9
成分 | 量(每个片剂)@BID |
β胡萝卜素 | 1.5mg |
黄体素 | <13.2mg |
玉米黄质 | <6.7mg |
维生素C | <200mg |
维生素E | <200IU |
铜 | 0.5mg |
锌 | 20mg |
维生素B2(核黄素) | 5.0mg |
叶酸盐/叶酸 | 100μg |
维生素B-12 | 3.0μg |
硒 | 20μg |
锰 | 5.0mg |
番茄红素 | 0.075mg |
DHA | 12.5mg |
迷迭香 | >1mg |
水 | TBD |
实施例10
AREDS软胶囊-假设NHANES正常摄入的最小水平&软胶囊,即正常膳食的补充物。
成分 | 量(每个片剂、胶囊、软胶囊等)@BID |
维生素A(β胡萝卜素) | 5mg |
维生素C | 200mg |
维生素E | 110IU |
铜 | 0.5mg |
锌 | 34mg |
ω-3脂肪酸(EPA/DHA) | 33mg |
黄体素(任选的) | 3.3mg |
玉米黄质(任选的) | 1.7mg |
迷迭香(任选的) | >1mg |
实施例11
成分 | 量(每个片剂、胶囊、软胶囊等)@QID |
黄体素 | 1.67mg |
玉米黄质 | 0.83mg |
维生素A(β胡萝卜素) | 2.8mg |
维生素C | 86mg |
维生素E | 90IU |
铜 | 0.mg |
锌 | 21.15mg |
维生素D | 50IU |
维生素K | 6.25μg |
维生素B1(硫胺) | 0.25mg |
维生素B2(核黄素) | 0..25mg |
维生素B3(烟酸) | 2.5mg |
维生素B6 | 0.25mg |
叶酸盐/叶酸 | 30μg |
维生素B-12 | 0.25μg |
生物素 | 7.5μg |
泛酸 | 2.5mg |
磷 | mg |
碘 | 37.5μg |
钙 | mg |
镁 | 25mg |
硒 | 25μg |
锰 | 0.5mg |
铬 | 30μg |
钼 | 18μg |
钾 | mg |
番茄红素 | 0.075mg |
DHA/EPA | 25mg |
迷迭香 | >1mg |
基于本文的公开内容,可以在不进行过度实验的情况下制备和实施本文所公开的和要求保护的所有组合物和/或方法。虽然已经根据优选实施方案对本发明的组合物和方法进行了描述,但是对于本领域技术人员显而易见的是,可以在不脱离本发明的概念、主旨和范围的情况下对本文所述的组合物和/或方法以及该方法的步骤或步骤顺序进行变化。更具体而言,显然可以用某些在化学上和结构上相关的物质代替本文所述的物质以获得类似的结果。对于本领域技术人员显而易见的所有该类替代和修改都在所附权利要求所定义的本发明的主旨、范围和概念内。
参考文献
将下面的参考文献特定引入本文作为参考,它们为本文所公开的内容提供了示例性操作或其它细节补充。
美国专利和公开申请
3,998,753
4,254,100
4,657,928
4,670,247
6,582,721
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20050106272
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书
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Chaney TEXTBOOK OF BIOCHEMISTRY WTTH CLINICAL CORRELATIONS,John Wiley&Sons,pp.970-1(1986)
其它公开物
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Claims (13)
1.膳食补充物,其包含约0.03重量%至0.3重量%的铜、约0.2重量%至4重量%的锌以及维生素C、维生素E和维生素A、黄体素和/或玉米黄质形式的活性类胡萝卜素,其中该膳食补充物中的维生素C浓度为约10重量%至30重量%,该膳食补充物中的维生素E浓度为约0.5重量%至25重量%维生素E,维生素A、黄体素和/或玉米黄质形式的活性类胡萝卜素浓度为约0重量%至30重量%,并且其还包含至少两种或更多种选自维生素K、维生素Bl、维生素B2、维生素B3、维生素B6、叶酸盐、维生素B12、生物素、泛酸、磷、碘、镁、硒、锰、铬、钼、钾、番茄红素、二十二碳六烯酸(DHA)和迷迭香的化合物。
2.权利要求1的膳食补充物,其中维生素A是β-胡萝卜素的形式。
3.权利要求1的膳食补充物,其包含:
其中每天摄入四个补充物以提供日剂量。
4.权利要求1的膳食补充物,其包含:
其中每天摄入四个补充物以提供日剂量。
5.权利要求1的膳食补充物,其包含:
其中每天摄入四个补充物以提供日剂量。
6.权利要求1的膳食补充物,其包含:
其中每天摄入四个补充物以提供日剂量。
7.权利要求1的膳食补充物,其包含:
其中每天摄入四个补充物以提供日剂量。
8.权利要求1的膳食补充物,其包含:
其中每天摄入两个补充物以提供日剂量。
9.权利要求1的膳食补充物,其包含:
其中每天摄入两个补充物以提供日剂量。
10.权利要求1的膳食补充物,其包含:
其中每天摄入两个补充物以提供日剂量。
11.权利要求1的膳食补充物,其包含:
其中每天摄入两个补充物以提供日剂量。
12.权利要求1的膳食补充物,其包含:
其中所述补充物是软胶囊,其中每天摄入两个补充物以提供日剂量。
13.权利要求1的膳食补充物,其包含:
其中所述补充物是软胶囊,其中每天摄入四个补充物以提供日剂量。
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US75183605P | 2005-12-20 | 2005-12-20 | |
US60/751,836 | 2005-12-20 |
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CN101330840A true CN101330840A (zh) | 2008-12-24 |
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CNA2006800475682A Pending CN101330840A (zh) | 2005-12-20 | 2006-12-20 | 用于抑制黄斑变性进展和促进健康视觉的组合物和方法 |
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US (1) | US20070141170A1 (zh) |
EP (1) | EP1962618A2 (zh) |
JP (1) | JP2009523127A (zh) |
KR (1) | KR20080078066A (zh) |
CN (1) | CN101330840A (zh) |
AU (1) | AU2006330567A1 (zh) |
BR (1) | BRPI0620210A2 (zh) |
CA (1) | CA2633868A1 (zh) |
WO (1) | WO2007076416A2 (zh) |
ZA (1) | ZA200805146B (zh) |
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2006
- 2006-12-20 CN CNA2006800475682A patent/CN101330840A/zh active Pending
- 2006-12-20 WO PCT/US2006/062434 patent/WO2007076416A2/en active Application Filing
- 2006-12-20 JP JP2008547759A patent/JP2009523127A/ja not_active Withdrawn
- 2006-12-20 CA CA002633868A patent/CA2633868A1/en not_active Abandoned
- 2006-12-20 US US11/613,938 patent/US20070141170A1/en not_active Abandoned
- 2006-12-20 AU AU2006330567A patent/AU2006330567A1/en not_active Abandoned
- 2006-12-20 ZA ZA200805146A patent/ZA200805146B/xx unknown
- 2006-12-20 BR BRPI0620210-1A patent/BRPI0620210A2/pt not_active IP Right Cessation
- 2006-12-20 KR KR1020087017214A patent/KR20080078066A/ko not_active Application Discontinuation
- 2006-12-20 EP EP06846731A patent/EP1962618A2/en not_active Withdrawn
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
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CN101559097B (zh) * | 2009-05-27 | 2012-10-31 | 北京工业大学 | 一种抗氧化防衰老的保健品 |
CN103796717A (zh) * | 2011-07-07 | 2014-05-14 | 霍华德基金会控股有限公司 | 视觉功效和/或黄斑色素沉着的改善或与之相关的改善 |
CN111163797A (zh) * | 2017-08-21 | 2020-05-15 | 伦萨有限责任公司 | 组合物和由其制备的营养补剂 |
CN113842385A (zh) * | 2021-10-26 | 2021-12-28 | 南京北极光生物科技有限公司 | 一种降低视网膜黄斑变性的方法 |
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EP1962618A2 (en) | 2008-09-03 |
US20070141170A1 (en) | 2007-06-21 |
WO2007076416A3 (en) | 2007-08-16 |
WO2007076416A2 (en) | 2007-07-05 |
BRPI0620210A2 (pt) | 2011-11-01 |
CA2633868A1 (en) | 2007-07-05 |
AU2006330567A1 (en) | 2007-07-05 |
KR20080078066A (ko) | 2008-08-26 |
ZA200805146B (en) | 2009-10-28 |
JP2009523127A (ja) | 2009-06-18 |
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