TWI572295B - 用於50歲以上個體以改善活力、免疫力、眼睛與骨頭健康之營養補充劑 - Google Patents
用於50歲以上個體以改善活力、免疫力、眼睛與骨頭健康之營養補充劑 Download PDFInfo
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- TWI572295B TWI572295B TW099101761A TW99101761A TWI572295B TW I572295 B TWI572295 B TW I572295B TW 099101761 A TW099101761 A TW 099101761A TW 99101761 A TW99101761 A TW 99101761A TW I572295 B TWI572295 B TW I572295B
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Description
本發明是有關供用於50歲以上個體以改善活力、免疫力、眼睛與骨頭健康的營養補充劑。
發生於成人的營養缺乏是很多的並且會依據地理環境以及個體的社會經濟地位而有變化。超過50歲之年齡的成人由於身體、認知或功能衰退而處於營養不足(undernutrition)[被定義為營養不良(hyponutrition)或缺乏營養(deficient nutrition)]的風險下。營養學家推測:在某些個案中,憂鬱、記憶喪失以及衰弱可能是起因於營養不足。慢性疾病[諸如阿滋海默氏症、關節炎,或骨質疏鬆症]亦可能干擾膳食製備以及飲食習慣。超過50歲的成人實際上常常無法準備他們自己的膳食而因此總體來說選擇忽略膳食。
即使健康狀況不是一個因素,超過50歲獨自生活的成人仍不可能費心為他們自己準備均衡以及營養的膳食。作為一另擇方式,許多人替換以經加工的、速食食物(ready-to-eat foods)來維生。經濟限制亦會影響食物選擇以及營養攝入。許多50歲以及更年長的成人是處於一有限收入的狀態下,而因此,在50歲以及更年長的成人之中的經濟考量以及營養知識與健康教育的缺乏使問題惡化。不活動或疾病會進一步抑制食慾(有如可能喪失一味覺);獨自吃飯或抑鬱的老年人亦會對食物失去興趣。食慾喪失亦可能起因於牙醫學問題[包括適應不佳的假牙、不佳的齒列以及牙周病]、缺少運動或一被減低的嗅覺與味覺。
即使是呈現理想健康而沒有上面所引述的任何疾病或複雜因素之超過50歲的成人仍可能因為會影響維生素、礦物質以及其它巨量與微量營養素之吸收的生理變化而遭受到營養缺乏。在胃腸生理中影響營養素生物可利用性的最大變化(它已經以年長的年齡而被認定)是萎縮性胃炎,其發生於一相當大百分比之超過50歲的成人之中。
膳食控制對於增強包括老化族群在內所需的腸吸收是有用的。雖然供用於超過50歲的成人的營養補充劑是商業上可獲得的,在該等補充劑中所含有的營養素的數量通常是任意的並且缺乏一科學上或實驗性的基礎。維生素與礦物質製劑著重於“完全”提供各個維生素和/或礦物質中之一者上而通常被投藥有如一般的營養補充劑,並且不會基於個體的生活方式(特別是在一超過50歲之年齡的族群中)而特別地被配方成要針對特殊的膳食與營養需求。
微量營養素是以小或微量之形式存在於食物中的元素或化合物,並且包括維生素、礦物質,或者是其它在食物中所發現到的許多尚未經過認證供作為一建議每日攝取量(RDA)的元素與化合物。巨量營養素是由提供營養素與卡路里的碳水化合物、脂肪以及蛋白質所構成,並且大多是經由食物以及膳食攝入而被消耗。一些微量營養素(諸如鈣、鈉、鉀、氯以及磷)以相對大的數量而被消耗,而許多其它者(諸如鐵、碘以及鋅)以小的數量而被消耗。維生素[諸如B12以及葉酸]以及礦物質[諸如硒]以非常小或微量而被消耗。由於人體無法合成許多對於人體是必需的化合物,這些特定的維生素以及礦物質僅可以由2種來源而被獲得:食物以及補充劑。
所有營養素的主要來源是食物。然而,大多數超過50歲的成人仍然無法經由食物消耗來符合必需微量營養素的RDA。因此,維生素以及礦物質補充已經變成一種符合被認可的醫療以及健康標準之經公認的方法。
在一用以對抗這些次-最佳的維生素位準(sub-optimal vitamin levels)的努力上,已經有各種不同的營養補充劑是公眾可獲得的而被製造。非常典型地,這些維生素以及礦物質補充劑配方被發展,藉此各個膳食成分是呈RDA的100百分比(100%),而沒有任何重點是在於要投遞特定消費者益處(特別是考慮到有如人年齡的生理因素)的關鍵成分或補充之上。
另擇的,某些人以及維生素產品經由巨大劑量維生素療法而讓營養補充達到極至。巨大劑量維生素療法是以相較於RDA更為非常大的數量(通常呈200%、300%等等的過度位準)來使用維生素。然而,維生素和/或礦物質的巨大劑量可能具有有害的效用,特別是在一超過50歲之年齡的族群中。熟習此技藝者可理解的是:投藥非常大劑量的某些維生素(例如維生素A、C、D以及B6)會致使維生素毒性以及其它嚴重的健康後果。維生素毒性是一種病況,其中一個人由於服用大量劑量的維生素而發展出有如副作用的症狀。維生素毒性[它亦被稱為維生素過多症或維生素中毒]在已發展國家中由於維生素補充劑的普及而變得更為常見。維生素在引起毒性所需的數量上以及在導致特定的症狀上呈多樣化。
因此,發明人想要提供被特定地配方要改善和/或增強活力、免疫力、眼睛與骨頭健康,同時針對在超過50歲之年齡的成人中的維生素與營養素缺乏以及生理變化而沒有一巨大劑量營養補充劑的負向副作用之配方。本發明的營養補充劑是針對特定適應症而沒有使用巨大劑量維生素療法之均衡的配方。
因此,對於一種提供正確數量的正確微量營養素以確保供疾病預防以及保護對抗營養流失與缺乏[由於生活方式、年齡、疾病以及不當膳食型態所造成的]所需的適當攝入之供用於超過50歲之年齡的成人之營養補充劑,存在有一需要。
在本發明的一個方面,一供用於在一50歲之年齡以及更年長的人類個體中提供營養支持以供改善活力、改善免疫力、眼睛以及骨頭健康的營養補充劑被提供,該營養補充劑包含有:一有效量的維生素A;一有效量的維生素B1;一有效量的維生素B2;一有效量的菸鹼酸;一有效量的維生素B6;一有效量的維生素B12;一有效量的維生素C;一有效量的維生素D;一有效量的維生素E;一有效量的維生素K;一有效量的生物素;一有效量的葉酸;一有效量的泛酸;一有效量的鈣;一有效量的氯;一有效量的鉻;一有效量的銅;一有效量的碘;一有效量的鐵;一有效量的鎂;一有效量的錳;一有效量的鉬;一有效量的磷;一有效量的鉀;一有效量的硒;以及一有效量的鋅;其中該活力、免疫力、眼睛以及骨頭健康被支持。
在本發明的又另一個方面,一供用於在一50歲之年齡以及更年長的人類個體中提供營養支持以供改善活力、改善免疫力、眼睛以及骨頭健康的營養補充劑被提供,該營養補充劑包含有:呈一為大約800mcg的數量的維生素A;呈一為大約1.4mg的數量的維生素B1;呈一為大約1.75mg的數量的維生素B2;呈一為大約20mg的數量的菸鹼酸;呈一為大約2mg的數量的維生素B6;呈一為大約2.5mcg的數量的維生素B12;呈一為大約100mg的數量的維生素C;呈一為大約5mcg的數量的維生素D;呈一為大約15mg的數量的維生素E;呈一為大約30mcg的數量的維生素K;呈一為大約62.5mcg的數量的生物素;呈一為大約200mcg的數量的葉酸;呈一為大約7.5mg的數量的泛酸;呈一為大約162mg的數量的鈣;呈一為大約36.3mg的數量的氯;呈一為大約40mcg的數量的鉻;呈一為大約0.5mg的數量的銅;呈一為大約100mcg的數量的碘;呈一為大約5mg的數量的鐵;呈一為大約100mg的數量的鎂;呈一為大約2mg的數量的錳;呈一為大約50mcg的數量的鉬;呈一為大約125mg的數量的磷;呈一為大約40mg的數量的鉀;呈一為大約30mcg的數量的硒;以及呈一為大約5mg的數量的鋅;其中該營養補充劑是呈一錠劑。
本發明的經年齡調整、目標化的營養補充劑對於50歲以及更年長的成人而言是特別有用的,不僅補充每日食物攝入,還支持特定的健康益處並且營養地補充每日膳食,補償生理變化與某些營養素的吸收不良,並且確保消費者的活力、健康與幸福。在此處所描述的營養補充劑被意欲要供用於投藥給超過50歲以及更年長的成人。目前沒有供用於這些更年長的消費者之商業上可獲得的營養補充劑,它們被特定地配方成要在50歲以及更年長的成人中以一單一營養補充劑的形式來增強和/或改善活力、免疫力、眼睛以及骨頭健康,而不使用巨大劑量維生素療法。
本發明的營養補充劑被設計要補充身體在一每日基礎上所損失的維生素與礦物質以及補償在50歲與更年長的成人中的生理變化,並且要提供身體一全範圍的營養素,該全範圍的營養素對於要達到對抗疾病、疲勞、倦怠的最佳功能以及促成人的全面幸福而言是必需的。此外,當人變得更年長時,他們的代謝功能改變並且衰退,其依次地會影響微量營養素攝入的效力。一超過50歲之年齡的成人的健康需求是非常不同的並且當試圖要提供營養補充時必須被考量到。例如,當一個人老化時,由於在胃酸度上的一減低、萎縮性胃炎的出現、食物結合的維生素B12吸收不良(food-bound vitamin B12 malabsorption)以及肝臟維生素B12儲存的缺少,血漿維生素B12的數量會部分地減低。對於更年長的成人,來自於營養補充劑之合成的B12要比在膳食中被天然地發現到的蛋白質-結合B12(protein-bound B12)所具者提供更生物可利用的形式。老化亦會降低維生素B6的結合形式的生物可利用性,並且老化-相關性慢性疾病會影響維生素B6的吸收與代謝。當發展在此處所揭示的營養配方時,發明人已考量到此等營養與膳食的差異,並且已發明獨特地經年齡調整的營養補充劑,俾以符合一老化族群之改變的膳食與代謝的需求。
本發明的此等經年齡調整的營養補充劑已經被獨特地配方要滿足超過50歲的成人之特定的營養需求。更特別地,發明人相信:呈量身訂作的數量(tailored amounts)之特定的營養組成物可以被用來改善活力、免疫力、眼睛與骨頭健康並且亦能克服生理變化。發明人相信:利用在此處所描述的該等方法以及營養補充劑,他們可達成這些最終目標/效用(經改善的或經增強的活力、免疫力、眼睛與骨頭健康)而沒有使用巨大劑量維生素療法(它在歷史上已經是達成該等效用的較佳方法)。
迄今,巨大劑量維生素療法已經是被用來預防和/或治療某些疾病或者疾病狀態的方法。傳統上,巨大劑量維生素療法是與微量營養素的數量(就該等成分而言是要比RDA更多)有關。如此處所用的,一巨大劑量將意指一微量營養素的一個劑量,它就微量營養素而言是大於RDA的200%。因此,發明人的目的是要產生供用於某些適應症(經改善的或經增強的活力、免疫力、眼睛與骨頭健康)而沒有採用巨大劑量療法的營養補充劑。因此,本發明的營養補充劑被認為是要避免通常與該等巨大劑量方法有關的潛在的維生素毒性以及其它有害的副作用。
當發明人在配方含有各種不同的呈大於或相等於RDA的數量之微量營養素的營養組成物時,必須要考慮的另一個因素是:要合併一足夠數量的維生素和/或礦物質的能力,俾以充分地補充此等成分的膳食攝入而沒有製造一太大以致於無法攝取、壓錠成錠劑或囊形片劑,或者將需要多重劑量的營養補充劑。由於吞嚥能力以及順從性對於50歲與更年長的成人而言是一獨有的顧慮,發明人的目的是要提供一種呈一單一劑量之能改善或增強活力、免疫力、眼睛以及骨頭健康的營養補充劑。
當配方一含有呈大於或相等於RDA的數量之微量營養素的營養組成物時,可能做不到的是:將這些成分組合以其它的微量營養素(甚至呈相等於或少於RDA的位準),因為這些大小和/或加工限制。發明人相信:本發明的營養補充劑,無論具有大於或相等於RDA的成分數量,可以容易地被配方成可被容易地吞嚥而不需要呈多重劑量來被投藥的錠劑、膠囊以及其它的劑型。較佳的,本發明的營養補充劑被投藥有如每天一劑量。
RDA被認為是要被人類消耗所需之微量營養素的適當數量的標準設定,作為他們每日膳食的一部分以確保該等微量營養素之足夠的膳食攝取。每隔數年,RDA會被審核、修改以及更新,俾以反映在科學以及營養信念上的改變。如此處所用的,所有關於RDA數值的參考資料是基於Directives Commission Directive 2008/100/EC(它已被修訂Council Directive 90/496/EEC)而引述。
大多數的人無法經由食物消耗來符合必需微量營養素的RDA。因此,維生素以及礦物質的補充已經變成一種符合被認可的醫療以及健康標準之經公認方法。
用於50歲以及更年長的成人的營養補充劑可全部以一單一劑量而被用來改善或增強活力、免疫力、眼睛與骨頭健康。如此處所用的,“經改善的活力”以及“經增強的活力”包括經改善的身體力氣、經改善的能量、經減低的倦怠以及睡意、經改善的氧的運輸以供能量生成、經增強的身體耐力以及精力,和/或在幸福的知覺與感覺上的一全面改善。據信:本發明的營養補充劑可在人體內釋放能量,俾以維持消費者的健康以及活力並且因而致使改善和/或增強該消費者的活力。
據信:葉酸鹽、硫胺素(維生素B1)、核黃素(維生素B2)、菸鹼酸、維生素B6、維生素B12、生物素以及泛酸全部都是可以被用來支持、增強和/或改善50歲以及更年長的成人之活力的營養素。
葉酸或葉酸鹽(陰離子形式)(亦被知曉為維生素B9)對於新細胞的生成與維持是必需的。這對於在快速細胞分裂以及生長[諸如嬰兒期以及懷孕]的期間是特別重要的。葉酸鹽對於合成供DNA複製所需的DNA鹼基[最特別是胸嘧啶,但亦可為嘌呤鹼基]而言是必需的。因此,葉酸鹽缺乏症會阻礙DNA合成以及細胞分裂,而最特別是會影響骨髓以及癌症(這兩者參與在快速的細胞分裂中)。由於葉酸鹽缺乏症會限制細胞分裂,紅血球生成[紅血球細胞(RBCs)的生成]被阻礙並且可能致使貧血。在一個較佳的具體例中,葉酸的數量是每天大約300mcg。在另一個較佳的具體例中,葉酸是呈一為大約RDA的150%的數量而存在。
維生素B1(亦稱為硫胺素)是一種具有藉由一甲撐鍵而被連結的噻唑以及嘧啶環並且具有一在體內大約為15天的生物半衰期的水-溶性物質。硫胺素對於神經功能以及碳水化合物代謝是必需的,並且以一藥學上可接受的維生素B1化合物的形式而被給藥。如此處所用的,“藥學上可接受的”是一適合供用於人類中而沒有過度副作用[諸如刺激、毒性以及過敏反應]的組分。有用的藥學上可接受的維生素B1化合物包括,但不限於:鹽酸硫胺素。在一個較佳的具體例中,維生素B1的有效量是每天大約1.6mg。在一個又更佳的具體例中,B1的有效量是大約1.65mg/天。在一個另擇的具體例中,B1的有效量是大約RDA的150%。
維生素B2(亦稱為核黃素)參與在許多代謝途徑中的氧化-還原反應以及經由呼吸鏈的能量生成。在一個具體例中,維生素B2的有效量係自每天大約2mg;最佳地呈每天大約2.1mg。在一個另擇的具體例中,B2的有效量是大約RDA的150%。
菸鹼酸對於細胞呼吸(有助於能量的釋放與碳水化合物、脂肪以及蛋白質的代謝)、適當的循環與健康的皮膚、神經系統的運作以及膽汁與胃液的正常分泌而言是必需的。它被使用在性激素的合成、治療精神分裂症以及其它的精神疾病上,並且是一種記憶-加強劑。在藥學劑量中所給定的菸鹼酸改善血液膽固醇圖譜,並且已經被用來清除身體的有機毒素[諸如某些殺蟲劑]。菸鹼酸的一較佳形式是菸鹼醯胺。在一個具體例中,菸鹼酸的有效量係自每天大約24mg。在一個另擇的具體例中,菸鹼酸的有效量是大約RDA的150%。
維生素B6或吡哆醇是涉及RNA與DNA的生成以及許多其它在人類體內的生物反應。磷酸吡哆醛(維生素B6的代謝性活化形式)是涉及巨量營養素代謝、神經傳導質合成、組織胺合成、血紅蛋白生成與功能以及基因表現的許多方面。有用的藥學上可接受的維生素B6化合物包括,但不限於:吡哆醇、吡哆醛以及吡哆胺,或它們的鹽類(包括,但不限於:吡哆醇HCL)。鹽酸醚衍生物磷酸吡哆醛一般作為一供用於許多反應的輔酶並且可以幫助促進去羧基作用、轉胺作用、消旋作用、脫去作用、取代以及β-基團相互轉變反應。一過量的吡哆醇可能引起某些神經[諸如本體受器神經]的一暫時性麻木;而會引起一種與本體感覺喪失相同之脫離肉體的感覺。當補充被停止時,這個病況是可逆轉的。因此,在一個較佳的具體例中,維生素B6的有效量是每天大約2mg,最佳地每天大約2.1mg。在一個另擇的具體例中,維生素B6的有效量是呈一為大約RDA的150%的數量而存在。
維生素B12[或鈷胺素]對於整體的代謝、神經系統功能、葉酸的代謝、高半胱胺酸還原以及紅血球細胞的生成是必要的。有至少3種鈷胺素的活化形式:氫鈷胺素、羥鈷胺素以及硝鈷胺素。因此,在一個較佳的具體例中,維生素B12的有效量是每天大約3mcg。在一個另擇的具體例中,維生素B12的有效量是呈一為大約RDA的120%的數量而存在。
生物素對於碳水化合物、蛋白質與脂肪的代謝是必要的並且對於健康的皮膚與毛髮而言是必需的。在本發明的一個較佳的具體例中,生物素的有效量是每天大約75mcg。在一個另擇的具體例中,生物素的有效量是呈一為大約RDA的150%的數量而存在。
泛酸(亦稱為維生素B5)是一種用以維持生命所需要的水-溶性維生素。泛酸對於形成輔酶-A(CoA)而言是必需的,並且在碳水化合物、蛋白質以及脂肪的代謝與合成上是重要的。泛醇(泛酸的衍生物)是維生素的一種更安定的形式並且通常在多維生素補充劑中被使用作為一維生素的來源。另一種常見的維生素的補充形式是泛酸鈣。泛酸鈣因為作為一鹽類而通常被使用於膳食補充劑中,它在消化道中比泛酸更為安定而允許有更好的吸收。在介於500-1200mg/天之間的泛酸的巨大劑量已經被顯示可降低總血清膽固醇、LDL-膽固醇以及三酸甘油酯,並且它可增加HDL-膽固醇。2g/天之劑量的泛酸鈣可降低在類風濕性關節炎病患中的晨僵的持續時間、失能的程度以及疼痛嚴重度。泛酸的一種較佳形式是泛酸鈣。在一個較佳的具體例中,泛酸的有效量是呈一每天自約9mg的數量而存在。在一個另擇的具體例中,泛酸的有效量是呈一為大約RDA的150%的數量而存在。
發明人更相信的是:呈特殊比例和/或數量的關鍵微量營養素的特定組合可以藉由增加對於調節和強化免疫系統以及維持人體的防禦系統而言是重要的抗氧化劑的位準來改善免疫力。該等包括維生素E、維生素C、維生素D、鐵、鋅、銅、硒以及維生素A的關鍵微量營養素全部都是可以被用來支持、增強和/或改善50歲以及更年長的成人的免疫力的營養素。
免疫系統的關鍵組分包括:皮膚與黏膜、纖毛、溶菌酶、補體蛋白質、吞噬細胞、自然殺手細胞、t-細胞與細胞激素,以及各種不同的抗體[更特別是5種Ig同型物(isotypes)]。有許多會影響這些免疫系統的因素,包括,但不限於:遺傳、用藥、手術、膳食與營養狀態、身體運動、環境與身體溫度、環境壓力以及污染。發明人相信:以在此處所揭示的數量的關鍵微量營養素(維生素E、維生素C、維生素D、鐵、鋅、銅、硒以及維生素A)的組合對於這些被認為可改善或增強50歲以及更年長的成人的免疫力之微量營養素而言是最佳的數量。如此處所用的,“經增強的免疫力”和/或“經改善的免疫力”應包括,但不限於:每年或每月較少的細菌和/或病毒感染;縮短或減少要復原自和/或減低嚴重度和/或較少的有關於或起因於該等細菌和/或病毒感染的副作用的時間;以及一整體之經增強的和/或經改善的生活品質。該等細菌和/或病毒感染包括,但不限於:由熟習此技藝者所熟知的細菌和/或病毒病原體所引起的感冒、流行性感冒、呼吸道過敏以及其它的感染。
維生素E(一種脂-溶性維生素)是一種涉及所有細胞的代謝的抗氧化維生素。它保護維生素A與必需脂肪酸免於在身體細胞內的氧化以及預防身體組織的衰退。維生素E是關於一群包括α-生育酚、β-生育酚、γ-生育酚以及δ-生育酚之相關物質的通稱。此外,這4種化合物的每一者具有一為天然形式的“d”形式,以及一為合成形式的“d1”形式。較佳地,在本發明的營養補充劑中,維生素E是呈天然的形式。在一個較佳的具體例中,維生素E的治療有效量是每天大約18mg。在一個另擇的具體例中,維生素E的有效量是呈一為大約RDA的150%的數量而存在。
維生素C[亦被知曉為抗壞血酸]是一種水-溶性抗氧化維生素。它在形成膠原蛋白[一種提供結構給骨頭、軟骨、肌肉以及血管的蛋白質]上是重要的。維生素C亦有助於鐵的吸收,並且幫助維持微血管、骨頭以及牙齒。作為一種水-溶性抗氧化劑,維生素C對於清除水性過氧化自由基(在這些破壞性物質有機會損壞脂質之前)而言是處於一獨特的位置中。它與維生素E(一種脂-溶性抗氧化劑)以及酵素麩胺基硫過氧化酶一起作用以停止自由基鏈反應。
維生素C可以增強對於各式各樣的疾病(包括感染性疾病以及許多類型的癌症)之身體的抗性。它藉由刺激抗體與免疫系統細胞[諸如吞噬細胞以及嗜中性白血球]的活性來強化以及保護免疫系統。維生素C促成各種不同的其它生化功能。這些包括調節神經系統的胺基酸肉鹼以及兒茶酚胺的生物合成。它亦幫助身體來吸收鐵以及分解組織胺。雖然維生素C在各個細胞中被發現,它在體內的關鍵部分是特別有用的。這些包括血液、皮膚、神經系統、牙齒與骨骼以及腺體[諸如胸腺、腎上腺以及甲狀腺]。在一個具體例中,維生素C的有效量是每天大約120mg。在一個另擇的具體例中,維生素C的有效量是呈一為大約RDA的150%的數量而存在。
維生素D是一群脂-溶性前激素,它的2種主要的形式是維生素D2[或麥角鈣化醇]以及維生素D3[或膽鈣化醇]。如此處所用的,術語維生素D亦意指這些物質的代謝物或其它的類似物。維生素D3在被暴露於陽光(特別是紫外線B輻射)下的皮膚中被產生。
維生素D在器官系統的維持上扮演一個重要的角色。曾有人顯示:藉由促進鈣與磷從在腸內的食物中的吸收以及藉由促進在腎臟內的鈣的再-吸收來調節在血液中的鈣與磷位準能夠使骨頭正常的礦質化。它對於骨頭生長以及骨頭再成型而言亦是必需的。維生素D亦已被推測會藉由促進吞噬作用、抗-腫瘤活性以及免疫調節功能而影響免疫系統。
維生素D缺乏症可能起因於不足夠的攝入加上不足夠的陽光暴露、限制維生素D的吸收之疾病、損害將維生素D轉變成活性代謝物的病況(諸如肝臟或腎臟疾病),或較少地,藉由一些遺傳性疾病。缺乏症導致受損的骨頭礦質化以及致使骨軟化疾病[在小孩中的佝僂病以及在成人中的骨質軟化症],並且可能促成骨質疏鬆症。然而,陽光暴露(為了避免缺乏症)會帶來其它的風險(包括皮膚癌);這個風險利用經由膳食或有如一膳食補充劑的膳食吸收而被避免。在一個具體例中,維生素D的有效量是呈一每天自約5mcg的數量而存在並且是有如維生素D3而存在。在一個另擇的具體例中,維生素D3的有效量是呈一為大約RDA的100%的數量而存在。
鐵被用於血紅蛋白以及肌紅蛋白的生成上。在此處所描述的營養補充劑中,鐵以一藥學上可接受的鐵化合物的形式而被給藥,如此處所用的,藥學上可接受的鐵化合物意指一適合供用於人類中而沒有過度副作用(諸如刺激、毒性以及過敏反應)的化合物。實例包括,但不限於:延胡索酸鐵(ferrous fumarate)、硫酸鐵、羰基鐵、葡萄糖酸鐵、氯化鐵、乳酸鐵、酒石酸鐵、琥珀酸鐵、麩胺酸鐵、檸檬酸鐵、焦磷酸鐵、異檸檬酸膽鹼)、碳酸鐵、鐵-糖-羧酸鹽複合物,以及它們的組合。鐵的較佳形式為延胡索酸鐵。在一個具體例中,鐵的有效量是呈一為每天大約2mg的數量而存在,更佳地每天2.1mg。在一個另擇的具體例中,鐵的有效量是呈一為大約RDA的15%的數量而存在。
鋅是一種天然存在於一些食物、被添加至其它的食物以及可有如一膳食補充劑而被獲得的必需礦物質。鋅涉及細胞代謝的許多方面。它對於大約100種酵素的催化活性而言是需要的,並且它在免疫功能、蛋白質合成、傷口癒合、DNA合成以及細胞分裂上扮演一個角色。鋅的每日攝入對於維持一穩定狀態是需要的,因為身體沒有特定的鋅儲存系統。鋅缺乏症的特徵在於生長遲緩、食慾的喪失以及受損的免疫功能。在更嚴重的例子中,鋅缺乏症會引起毛髮減少、腹瀉、延遲的性成熟、陽萎、在男性中的性腺低能症以及眼睛與皮膚損傷。體重減少、傷口的延遲癒合、味覺不正常以及精神萎靡亦可能發生。
嚴重的鋅缺乏症亦可能抑制免疫功能,以及甚至輕至中程度的鋅缺乏症可能損害巨噬細胞與嗜中性白血球功能、自然殺手細胞活性以及補體活性。身體需要鋅來發展以及活化T-淋巴細胞。具有低的鋅位準的個體已顯示出對於致裂物質以及其它在免疫力上的不利改變之經降低的淋巴細胞增生反應,它可以藉由鋅補充而被矯正。此等在免疫功能上的改變可能解釋了為何低的鋅狀態已經與針對肺炎以及其它感染之經增加的易感性有關連。
數種鋅的形式(包括葡萄糖酸鋅、硫酸鋅、氧化鋅以及醋酸鋅)可被用於此處所描述的營養補充劑中。元素鋅的百分比因著形式而呈多樣化。例如,大約有23%的硫酸鋅是由元素鋅所構成的;因此,220mg的硫酸鋅含有50mg的元素鋅。鋅的較佳形式為氧化鋅。在一個具體例中,鋅的有效量是呈一為每天大約5mg的數量而存在。在一個另擇的具體例中,鋅的有效量是呈一為大約RDA的50%的數量而存在。
銅[一種必需的微量礦物質]對於在我們體內的兩種非常重要的酵素的功能而言是重要的。第一種是過氧化物歧化酶(SOD),它是可於人類中獲得的最有力的自由-基鬥士中之一者。以此方式,銅支持免疫系統以及我們用以對抗疾病的能力。
銅對於鐵利用(其對於能量而言是需要的)亦是必要的。假若銅位準是低的並且鐵被抑制,疲勞以及肌肉衰弱會跟著發生。藉由提供鐵,銅亦確保健康的將氧運送至紅血球細胞的呼吸功能。此外,我們的身體需要銅來產生在人類中是一關鍵能量生產者的三磷酸腺苷(ATP)。在此處所描述的營養補充劑中,銅以一藥學上可接受的形式而被投藥,其包括,但不限於:氧化銅、檸檬酸銅、硫酸銅、碳酸銅、葡萄糖酸銅,以及它們的組合。在一個較佳的具體例中,銅是呈一為每天大約0.5mg的數量而存在。在一個另擇的具體例中,銅是呈一為大約RDA的50%的數量而存在。
硒是一種必需的微量元素,它作用有如一涉及抗氧化保護以及甲狀腺激素代謝之酵素的組分。硒具有抗氧化性質,並且已經被顯示可降低心臟病發作以及心臟疾病的風險。硒缺乏症的特殊徵兆未曾在人類中被描述,但是非常低的硒狀態對於發生於中國的硒-缺乏區域內的一種幼年心肌病[克山病(Keshan Disease)]以及一種軟骨營養不良(chondrodystrophy)[溪山病(Kashin-Beck Disease)]之病因學而言是一個因素。在一個具體例中,硒的有效量是呈一為每天大約30mcg的數量而存在。在一個另擇的具體例中,硒的有效量是呈一為大約RDA的55%的數量而存在。
維生素A[一種在碳與氫之間由雙-極性共價鍵所形成的雙-極性分子]被連結至相似形狀分子[類視色素]的一個家族中。它的重要部分是可以呈數種形式而被發現的視網基基團。維生素A可被發現有如一種酯,主要是軟脂酸視網酯[在食物中被發現並且在小腸中被轉變成為視網酮]。維生素A亦可存在有如視網醛或有如視網酸。維生素的前驅物存在於植物來源的食物中而有如類胡蘿蔔素家族的化合物中的某些成員。在來自於植物的食物中所發現到之常見的原維生素A類胡蘿蔔素是β胡蘿蔔素、α胡蘿蔔素以及β玉米黃素。在這些之中,β-胡蘿蔔素被最有效率地製成視網酮。α胡蘿蔔素以及β玉米黃素亦被轉變成為維生素A,但僅有一半是如β胡蘿蔔素一樣有效率地。
維生素A在各種不同遍及身體的功能[諸如:視覺、基因轉錄、免疫功能、胚胎發育與繁殖、骨頭代謝、造血作用、皮膚健康、降低心臟疾病的風險以及抗氧化活性]中扮演一個角色。維生素A缺乏症可能發生有如一原發性或續發性缺乏症。一原發性維生素A缺乏症發生在無法消耗一足夠攝入的黃色與綠色蔬菜、水果以及肝臟的小孩以及成人之中。續發性維生素A缺乏症是與脂質的慢性吸收不良、受損的膽汁生成與釋放、低的脂肪膳食以及慢性暴露至氧化劑(諸如香菸煙霧)有關連。維生素A是一種脂溶性維生素,並且端視用於分散至小腸內而導致維生素A由低-脂肪膳食中的不佳利用的微胞溶解。鋅缺乏症亦可能損害維生素A的吸收、輸送以及代謝,因為鋅對於維生素A輸送蛋白質的合成以及將視網酮氧化成為視網醛是必要的。
在一個較佳的具體例中,視網酮(呈醋酸維生素A的形式)與β胡蘿蔔素的維生素A比例為50:50。在一個又更佳的具體例中,維生素A(視網酮+β胡蘿蔔素)的總量是每天大約800mcg。在一個另擇的具體例中,存在於營養補充劑中的維生素A的總量是大約RDA的100%。
供用於50歲以及更年長的成人的營養補充劑亦是具有較高位準的關鍵營養素之特別地經均衡的營養組合物,並且呈在此處所描述的數量與比例可有助於支持眼睛健康。發明人相信具有呈在此處所描述的數量之葉黃素、維生素A、核黃素(維生素B2)以及維生素E的營養組合物可有助於在一超過50歲之年齡的成人中支持和/或改善眼睛健康。
葉黃素(一種天然存在的類胡蘿蔔素)被發現到在黃斑[一種負責中央視覺之小區域的視網醛]中會被濃縮。有關於天然濃縮的假設是:葉黃素會幫助保護免於氧化壓力以及高-能量光。各種不同的研究已經顯示:一直接的關係存在於葉黃素攝入以及眼睛內的色素沉著之間。葉黃素亦被相信的是:在增加黃斑色素沉著上扮演一個角色,並且因此降低有關於眼睛疾病[諸如老年性黃斑退化(AMD)]的風險。在一個較佳的具體例中,葉黃素的有效量是每天大約1000mcg。
供用於50歲以及更年長的成人的營養補充劑亦是具有較高位準的關鍵營養素之特別地經均衡的營養組合物,並且呈在此處所描述的數量與比例可有助於支持骨頭健康。發明人相信具有呈在此處所描述的數量之鈣、維生素K以及維生素D的營養組合物可有助於在一超過50歲之年齡的成人中支持骨頭健康。
鈣是一健康膳食中的一重要組分並且是一種生命所必需的礦物質。國家骨質疏鬆症基金會(National Osteoporosis Foundation)聲稱:“鈣對於在早年發展更強壯、更緻密的骨頭以及在晚年維持骨頭強壯與健康而言扮演一重要的角色”。大約99%之身體的鈣被儲存於骨頭以及牙齒內。長期鈣缺乏症會致使佝僂病以及不佳的血液凝結,並且在一停經期的女性的例子中,它會致使骨質疏鬆症。雖然終身的缺乏會影響骨頭以及牙齒形成,過度-滯留會引起高血鈣症(在血液中被升高的鈣位準)、受損的腎功能以及其他礦物質之被減低的吸收。鈣化合物的藥學上可接受的來源包括,但不限於:碳酸鈣、磷酸二鈣、磷酸三鈣、葡萄糖酸鈣、乳酸鈣、檸檬酸鈣,以及它們的組合。在一個較佳的具體例中,鈣是呈一為每天大約162mg的數量而存在。在一個另擇的具體例中,鈣是呈一為RDA的20%的數量而被提供。
維生素K意指一群對於某些蛋白質的轉錄後修飾(postranslational modificaiton)而言是必需的親脂性(lipophilic)、疏水性(hydrophobic)維生素。化學上它們是2-甲基-1,4-萘醌衍生物。維生素的維生素K群組中的所有成員共有一經甲基化的萘醌環結構,並且在被連接至3-位置上的脂族側鏈上呈多樣化。葉綠醌(亦被知曉為維生素K1)在它的側鏈上一定含有4個異戊二烯殘基,它們之中的一者是未飽和的。
一般所接受的是:萘醌是官能基基團,而使得對於所有K-維生素而言作用機制都是相似的。然而,有關於腸吸收、輸送、組織分配以及生物-可利用性,實質上的差異可被預期。這些差異是藉由各種不同側鏈之不同的親脂性以及藉由它們所被發現的不同食物基質而被造成的。維生素K缺乏症是非常罕見的。當身體無法由腸道(中適當地吸收維生素時它會發生。維生素K缺乏症亦可能發生在長期利用抗生素的治療之後。帶有維生素K缺乏症的個體通常更有可能具有淤血以及出血。維生素K是一種活性血液凝結劑並且幫助骨頭形成。較佳地,維生素K是呈維生素K1的形式並且是呈一為每天大約30mcg的數量。在一個另擇的具體例中,維生素K1是呈一為RDA的40%的數量而存在。
為了要提供一種不僅用以改善和/或增強活力、免疫力、眼睛以及骨頭健康之供用於超過50歲的成人的營養補充劑,額外的微量營養素亦被合併。服用具有全部維生素以及礦物質(呈正確比例與數量之營養素)的單一劑量(它不僅有益於活力、免疫力、眼睛以及骨頭健康,亦有益於膳食營養補充)的好處是:它確保一較高的順從率(compliance rate)。50歲以及更年長的成人可服用1劑量並且接收到維生素與礦物質以及微量營養素供作為每日膳食補充,而非必須服用多重補充劑、丸劑、錠劑或其它劑型。例如,額外的微量營養素包括,但不限於:磷、氯、鉻、碘、鎂、錳、鉬以及鉀。
磷對於骨頭發展而言是必需的並且是一種存在於所有重要類型的生化化合物之中的成分。磷(在三磷酸腺苷中呈磷酸的形式)是一種對於大多數代謝步驟而言是必需的關鍵能量來源。藥學上可接受的磷化合物包括,但不限於:磷酸鈣、磷酸鈉、磷酸鉀、磷酸銨、磷酸甘油的形式,以及它們的組合。在一個較佳的具體例中,磷的數量是大約125mg。在一個另擇的具體例中,磷是大約RDA的18%。
氯對於幫助維持在體內的離子以及流體平衡是必需的,並且是一種胃以及腸分泌的必需組分。有用的藥學上可接受的氯化合物包括,但不限於:氯化鈉、氯化鉻、氯化亞錫以及氯化鉀。在一個較佳的具體例中,氯的數量是大約36mg;在一個又更佳的具體例中,氯的數量是大約36.3mg。在一個另擇的具體中,氯是大約RDA的5%。
鉻幫助調節葡萄糖代謝(被用於合成脂肪酸以及膽固醇)、幫助輸送蛋白質、降低LDL血液位準,以及提升高密度脂蛋白血液位準。在該營養補充劑中,鉻以一藥學上可接受的鉻化合物的方式而被給藥。有用的藥學上可接受的鉻化合物包括,但不限於:氯化鉻、酵母菌-結合鉻(yeast-bound chromium)、吡啶甲酸(picolinate)、菸鹼酸-結合鉻,以及它們的組合。在一個較佳的具體例中,鉻是呈一為大約40mcg的數量而存在。在一個另擇的具體例中,鉻是大約RDA的100%。
碘有助於代謝脂肪並且對於適當的甲狀腺功能而言是必需的,以及有助於降低纖維囊性乳房病況。在本發明的營養補充劑中,碘以一藥學上可接受的碘的形式而被投藥,其包括,但不限於:碘化鉀、碘化鈉,以及它們的組合。在一個較佳的具體例中,碘是呈碘化鉀的形式。在又另一個具體例中,在該營養補充劑中的碘的數量是大約100mcg。在一個另擇的具體例中,碘是大約RDA的67%。
鎂被用於骨頭形成與生長、防止骨質流失、鬆弛冠狀動脈,被用於控制子癲前症、治療心律不整,以及控制糖尿病。在該營養補充劑中,鎂以一藥學上可接受的鎂化合物的形式而被給藥。有用的藥學上可接受的鎂化合物包括,但不限於:硬脂酸鎂、碳酸鎂、氧化鎂、氫氧化鎂、硫酸鎂,以及它們的組合。在一個較佳的具體例中,鎂是呈一為大約100mg的數量而存在。在一個另擇的具體例中,鎂是大約RDA的27%。
鉬可促進脂肪、碳水化合物與鐵的適當代謝以及可保護對抗某些癌症。藥學上可接受的鉬化合物包括,但不限於:鉬化納、鉬胺基酸螯合物,以及它們的組合。在一個較佳的具體例中,鉬是呈一為大約50mcg的數量而存在。在一個另擇的具體例中,鉬是大約RDA的100%。
鉀對於調節水平衡、酸度的位準、血壓以及神經肌肉功能而言是必需的。鉀對於碳水化合物以及蛋白質代謝而言亦是必需的。在該營養補充劑中,鉀以一藥學上可接受的鉀化合物的形式而被給藥。有用的藥學上可接受的鉀化合物包括,但不限於:氯化鉀、硫酸鉀、甘油磷酸鉀、檸檬酸鉀、葡萄糖酸鉀、磷酸鉀,以及它們的組合。在一個較佳的具體例中,鉀是呈一為大約40mg的數量而存在。在一個另擇的具體例中,鉀是大約RDA的2%。
在體內的一低的錳位準可能與糖尿病有關連。因此,錳似乎在血糖位準的控制上具有一角色。錳在胺基酸以及某些維生素的代謝上亦可能具有一角色。藥學上可接受的錳化合物包括,但不限於:氯化錳、硫酸錳,以及它們的組合。在一個較佳的具體例中,錳是呈一為大約2mg的數量而存在。在一個另擇的具體例中,錳是大約RDA的100%。
該營養補充劑是要呈一單一單位劑量形式來被投藥。如此處所用的,單一單位劑量形式應意指一劑型,其中該組成物的所有微量營養素是呈一單一丸劑、錠劑、囊形片劑、膠囊、可嚼式錠劑、快速溶解錠劑、發泡錠劑、硬明膠膠囊、軟明膠膠囊、粉末、液體懸浮液以及食物產品。然而,所認知到的是:該單一單位劑量形式可以被投藥有如一單一劑量(亦即,每天服用1個丸劑);或呈多重劑量。較佳地,該劑型被投藥有如每天1劑量。
在此處所描述的該等營養補充劑以及組成物可以被製備成呈各種不同的形式,諸如下列藥學組成物:一丸劑、一錠劑、一囊形片劑、一膠囊、一可嚼式錠劑、一快速溶解錠劑、一發泡錠劑、一硬明膠膠囊、一軟明膠膠囊、一粉末、一液體懸浮液以及一食物產品。熟習此技藝者將會認知到的是:還有其它供用於將該營養補充劑投遞至一使用者的可行方法。在一個較佳的具體例中,該營養補充劑是呈一固體劑型;在一個又更佳的具體例中,該固體劑型是一錠劑。
此外,這些組成物可以使用在本技藝中所熟知的傳統配備以及技術而被製得。當製備合併有本發明的組成物的劑型時,該等營養組分通常被調和以傳統的賦形劑,諸如結合劑,包括明膠、預膠化的澱粉以及類似之物;潤滑劑,諸如氫化植物油、硬脂酸以及類似之物;稀釋劑,諸如乳糖、甘露糖以及蔗糖;崩解劑,諸如羧基甲基纖維素以及澱粉甘醇酸鈉;懸浮劑,諸如聚維酮、聚乙烯醇以及類似之物;吸收劑,諸如二氧化矽;防腐劑,諸如對氫苯甲酸甲酯、對氫苯甲酸丙酯以及苯甲酸鈉;介面活性劑,諸如月桂硫酸納、聚山梨醇酯80以及類似之物;以及著色劑,諸如F.D. & C染劑以及類似之物。錠劑可含有載劑[諸如乳糖以及玉米澱粉],和/或潤滑劑(諸如硬脂酸鎂)。膠囊可含有稀釋劑(包括乳糖以及乾燥玉米澱粉)。水性懸浮液可含有組合以活性成分的乳化以及懸浮劑。口服劑型可進一步含有增甜和/或調味料和/或染色試劑。
此外,除了在此處所描述的不活性成分,該等組成物較佳地包含有額外的微量營養素,俾以補充那些微量營養素的每日膳食攝入。
雖然本發明已就某些特定具體例而被描述,將被理解的是:在不背離本發明之下許多修飾以及變化可藉由那些熟習此技藝者而被作出。因此,意欲的是:藉由隨文檢附的申請專利範圍來涵蓋所有該等修飾以及變化而可落在本發明的真實精神以及範疇之內。
Claims (3)
- 一種供用於在一50歲之年齡以及更年長的人類個體中提供營養支持以供改善活力、改善免疫力、眼睛以及骨頭健康的營養補充劑,其包含有:呈一為大約800mcg的數量的維生素A;呈一為大約1.4mg的數量的維生素B1;呈一為大約1.75mg的數量的維生素B2;呈一為大約20mg的數量的菸鹼酸;呈一為大約2mg的數量的維生素B6;呈一為大約2.5mcg的數量的維生素B12;呈一為大約100mg的數量的維生素C;呈一為大約5mcg的數量的維生素D;呈一為大約15mg的數量的維生素E;呈一為大約30mcg的數量的維生素K;呈一為大約62.5mcg的數量的生物素;呈一為大約200mcg的數量的葉酸;呈一為大約7.5mg的數量的泛酸;呈一為大約162mg的數量的鈣;呈一為大約36.3mg的數量的氯;呈一為大約40mcg的數量的鉻;呈一為大約0.5mg的數量的銅;呈一為大約100mcg的數量的碘;呈一為大約5mg的數量的鐵;呈一為大約100mg的數量的鎂;呈一為大約2mg的數量的錳;呈一為大約50mcg的數量的鉬;呈一為大約125mg的數量的磷;呈一為大約40mg的數量的鉀;呈一為大約30mcg的數量的硒;以及呈一為大約5mg的數量的鋅。
- 如請求項1之營養補充劑,其中該營養補充劑是呈一錠劑。
- 如請求項1之營養補充劑,其中該維生素A的有效量是 800mcg;該維生素B1的有效量是1.4mg;該維生素B2的有效量是1.75mg;該菸鹼酸的有效量是20mg;該維生素B6的有效量是2mg;該維生素B12的有效量是2.5mcg;該維生素C的有效量是100mg;該維生素D的有效量是5mcg;該維生素E的有效量是15mg;該維生素K的有效量是30mcg;該生物素的有效量是62.5mcg;該葉酸的有效量是200mcg;該泛酸的有效量是7.5mg;該鈣的有效量是162mg;該氯的有效量是36.3mg;該鉻的有效量是40mcg;該銅的有效量是0.5mg;該碘的有效量是100mcg;該鐵的有效量是5mg;該鎂的有效量是100mg;該錳的有效量是2mg;該鉬的有效量是50mcg;該磷的有效量是125mg;該鉀的有效量是40mg;該硒的有效量是30mcg;以及該鋅的有效量是5mg。
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