TWI613969B - 用於營養素輸送之組成物和方法 - Google Patents
用於營養素輸送之組成物和方法 Download PDFInfo
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- TWI613969B TWI613969B TW100143557A TW100143557A TWI613969B TW I613969 B TWI613969 B TW I613969B TW 100143557 A TW100143557 A TW 100143557A TW 100143557 A TW100143557 A TW 100143557A TW I613969 B TWI613969 B TW I613969B
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Abstract
本揭露提供用於輸送營養素給需要小體積營養支持之個體(諸如早產兒)的組成物和方法。該組成物可包含二十二碳六烯酸(DHA)及花生四烯酸(ARA)之乳液。該營養組成物可用於例如矯正營養缺陷，其係藉由增加個體之營養素(諸如ω-3或ω-6長鏈多不飽和脂肪酸)攝取。該營養組成物適合以營養補充劑經腸輸送或以母乳或嬰兒配方強化劑經口服輸送。
Description
本揭露關於改良之包含二十二碳六烯酸(DHA)及花生四烯酸(ARA)的腸內營養組成物，亦關於用於提供罹患營養缺陷之人群(如早產兒和/或低出生體重嬰兒)為穩定乳液形式之營養支持品的方法。本揭露之液態營養組成物可能含有分散在水性組分(其包含諸如胺基酸、維生素、礦物質及其他營養素、或前述各項之組合)中之脂質組分(其含有DHA和/或花生四烯酸(ARA)之乳液)。該營養組成物可能適合經由鼻胃管經腸輸送、胃內灌食經幽門投服和/或任何其他可將該營養組成物直接引入個體消化道中的投服方式。於一些體系中，該營養組成物為適合加入用於經口營養之人類母乳或嬰兒配方中的營養強化劑。
本揭露關於改良之腸內營養組成物，其解決患病人群之營養缺陷以及從這些不足產生的生理性及其他後果。尤其是，本揭露解決可能出現在早產兒和/或低出生體重嬰兒中的營養缺陷問題。
由於短期生存及長期之生長和發育受到威脅，用於早產兒之營養支持品是非常重要的。提供早產兒營養支持品的重要目標包括促進與胎兒發育期間所達成者相等之增長速率和養分的累積，從而將神經發展成果最優化並奠定長
期健康堅實的基礎。這些目標並不容易達成，因為危重症、低出生體重、早產之嬰兒的腸道及其他器官系統伴隨著病變或不成熟，因此通常無法承受傳統之經腸餵食。因此，全腸外營養(TPN)為開立之提供營養支持品的唯一或較佳方法。雖然TPN能救回生命，但它不是營養支持品的完美方法。TPN缺乏許多重要的營養素，且其限制性可能對嬰兒具有長遠的生理上和發育上的後果。
低出生體重和極低出生體重嬰兒特別容易同時發生產後增長失敗和營養缺陷。然而，TPN無法充分供應寶貴的營養素，諸如二十二碳六烯酸和/或花生四烯酸。因此，許多早產兒未接受充足的DHA和/或ARA供應。
在食用正常飲食之正常個體中，其中該正常飲食提供足夠之DHA和ARA，通常並不需要補充DHA或ARA，因為在子宮內及產後成長期間大量ARA和DHA會存積在人類大腦及其他組織中。(Clandinin MT et al.,"Requirements of newborn infants for long chain polyunsaturated fatty acids".Acta Paediatr Scand 1989；351 Suppl：63-71.)事實上，因為胎盤提供胎兒DHA及ARA，胎兒在懷孕的最後三個月累積諸如DHA及ARA之長鏈多不飽和脂肪酸(LCPUFAs)。(A.Lapitlonne et.Al,"Reevaluation of the DHA requirement for the premature infant",Prostaglandins,Leukotrienes and Essential Fatty Acids 81(2009)143-150.)但在早產的情況下，嬰兒面對突如其來之胎盤LCPUFA供應中斷。早產
兒通常為重病且面臨許多可能會迅速耗盡其可用之LCPUFA存積的生理壓力，而所造成之LCPUFA不足可能會使早產嬰兒更不成熟。
由於早產兒們的胃腸道不成熟、營養儲存不足且對養分需求高以支持成長，要滿足早產兒的營養需求是個問題。(L.G.Smithers et al.,"Effect of two doses of docosahexaenoic acid(DHA)in the diet of preterm infants on infant fatty acid status：Results from the DINO trial",Prostaglandins,Leukotrienes and Essential Fatty Acids 79(2008)141-146.)然而，必需脂肪酸及其衍生物在危重症早產兒中供給不足時似乎可能導致視覺功能及神經發育的長期障礙。(D.Driscoll et al.,"Pharmaceutical and clinical aspects of parenteral lipid emulsions in neonatology",Clinical Nutrition(2008)27,497-503.)。在腸道外營養及TPN溶液中缺乏諸如DHA及ARA等長鏈多不飽和脂肪酸的情況下，這些問題會加劇。
事實上，目前市場上之TPN及其他胃腸道外營養補充劑最多只有提供極少量之預製DHA和ARA。DHA為ω-3脂肪酸且為大腦及視網膜中是最豐富的長鏈多不飽和脂肪酸，被認為對嬰兒之大腦和視力的適當發展至關重要。雖然存有從飲食中之亞麻酸生物合成的代謝途徑，但此途徑對生物能量上是不利的，且哺乳動物自食物來源所提供之預製DHA取得其大部分DHA。則對於嬰兒而言，DHA
的來源通常是人類母乳；然而，提供給早產兒之胃腸道外配方一般而言缺乏DHA。
胃腸道外配方通常亦無法提供足量之花生四烯酸。ARA為一種ω-6 LCPUFA，其主要作為與血液、肝臟、肌肉及其他主要器官系統中之磷脂聯結的結構性脂質。ARA係經由將亞油酸延長及去飽和來合成。然而，大部分ARA必須由飲食提供。ARA在身體的迅速增長期間尤為重要，因此是嬰幼兒營養的重要組分。
大量硏究已指出提供給嬰兒之未經補充的早產兒奶提供不足量之滿足早產兒需求所必需的數種營養素(Davis,D.P.,"Adequacy of expressed breast milk for early growth of preterm infants",Archives of Disease in Childhood,52,p.296-301,1997)。雖然由於活動性、能量消耗、養分吸收效率、疾病和利用能源合成組織之能力的不同，嬰兒彼此間之確切需求有所差異，現有之胃腸道外營養來源是不足的。
此外，早產嬰兒往往無法良好承受餵食量，而營養素必須提供在可接受之體積內(通常係經腸投服)。用於早產兒經腸餵食之適當方法係根據胎齡、出生體重、臨床狀況及主持醫療人員的意見。特定之餵食決定係根據嬰兒協調吸吮，吞嚥和呼吸之能力。通常，早產兒或較不成熟，虛弱或重病的嬰兒需要管餵，以避免肺吸入的風險並節省能源。
鼻胃管餵食常用於新生兒重症醫療單位且可藉由大丸
藥或連續灌注經營養強化之人類母乳或其他營養補充劑達成。極低出生體重之嬰兒及先前未能承受大丸藥餵食之嬰兒可能較能承受連續餵食；然而，如先前所討論者，減少或不足之營養輸送為與本技藝已知之連續餵食方法有關的問題。
因此，需要有一種穩定的營養組成物，其能被早產兒良好耐受且能以容易被罹患營養缺陷之對象和照顧者接受並服用的形式輕易地投與對象。
諸如早產兒之類的群體經常苦於營養缺陷，因為提供給他們的飲食缺乏如上述之重要營養素。因此，本技藝有此需求來提供能支持嬰兒發育之包含寶貴營養(諸如DHA和ARA)的營養組成物。因此，本揭露之營養組成物及方法提供罹患營養缺陷之對象腸內營養支持品，其係經由輸送腸外營養素及其他嬰兒配方中缺乏或數量不足之重要的營養素來促進最佳的健康和發展。
因此，簡言之，本揭露針對用於解決需要小體積之營養支持品的個體(如早產兒)中之營養缺陷的穩定營養組成物，並針對用於促進那些個體之健康發展的方法。本揭露提供用於投與個體脂肪酸(諸如DHA和/或ARA)及其他營養物質，以防止發展出營養缺陷的組成物和/或經由增加個體攝取營養素，諸如ω-3或ω-6長鏈多不飽和脂肪酸來修正現有之營養缺陷。
於一種體系中，本揭露包含含有二十二碳六烯酸乳液和/或花生四烯酸之乳液的營養組成物。
於一種體系中，本揭露包含用於提供營養支持品給個體的方法，該方法包含投與個體包含二十二碳六烯酸乳液和/或花生四烯酸之乳液的營養組成物。
另一種體系包含用於強化適合口服之人類母乳或嬰兒配方的營養補充劑。
要理解的是，上述之一般描述及以下之詳細說明二者均呈現本揭露之體系且旨在提供用於理解本揭露所主張之性質和特性的概述或框架。該描述係用於解釋所主張之題材的原則和操作。熟習本技藝之人士在閱讀下列揭露內容後將可輕易地察知本揭露之其他及進一步的特點和優點。
本揭露提供營養組成物及提供營養支持品的方法。該營養組成物包括含有DHA和ARA之脂質組分且適合用於輸送給患有營養不良之個體(諸如早產嬰兒)。本揭露進一步提供用於添加在人類母乳或嬰兒配方中之改良的營養強化劑。該營養強化劑包含DHA和ARA之穩定乳液。本揭露再進一步提供用於提供營養支持品給予個體(諸如早產兒)的方法。本揭露之充分及有用的揭露內容(包括其針對本技藝之一般技術人士的最佳模式)闡述於下列專利說明書中。
下文中，“經腸投服”包括，但不限於經由鼻胃管餵
食、口胃管餵食、胃內灌食、或經幽門投服。“經腸投服”亦可能包括除了經口餵食以外，本技藝已知之任何其他用於將營養組成物直接引入消化道的方法。
“營養組成物”一詞包括營養補充劑、人類母乳營養強化劑、嬰兒配方營養強化劑，等，但不侷限於彼等。本揭露之營養組成物可能適合用於經腸投服或經口投服。
“早產兒”係指胎齡37週前出生的個體。“預產期前嬰兒”一詞可與“早產兒”一詞交替使用。
“低出生體重嬰兒”意指嬰兒出生時體重低於2500克(約5磅8盎司)。
“非常低出生體重嬰兒”意指嬰兒出生時體重低於1500克(約3磅4盎司)。
“極低出生體重嬰兒”意指嬰兒出生時體重低於1000克(約2磅3盎司)。
“嬰兒”意指年齡範圍在出生到不超過約1歲的人類個體，包括矯正年齡從0至約12個月的嬰兒。“矯正年齡”一詞係指嬰兒之實足年齡減去嬰兒早產的時間長度。因此，矯正年齡為如果嬰兒達足月時之年齡。嬰兒一詞包括低出生體重兒、非常低出生體重嬰兒、極低出生體重兒及早產兒。
“乳液”係指包含分散相及連續相之二或多種不相溶混之液體的混合物。在一種乳液中係將一種稱為分散相之液體分散在稱為連續相、體相或水性組分之其他液體中。
“單位劑量”係指單一包裝之營養組成物。
除非另有規定，此處所使用之所有百分比、份數及比率係以全部組成物之重量計。
本揭露之營養組成物亦可能大體上不含此處所描述之任何可選擇或選定之成分，其先決條件為其餘之營養組成物仍包含所有此處描述之所需成分或特性。在這種情況下，除非另有規定外，“大體上不含”一詞係指所選擇之組成物中所含有之可選擇的成分少於一個功能量，通常係少於0.1重量%，且亦包括0重量%之這類可選擇或選定之成分。
除非另有規定或明確暗示與參考的情況相反，本揭露中所有單數特性或限制之指稱應包括對應之複數特性或限制，反之亦然。
除非另有規定或明確暗示與所參考之組合中的情況相反，所有此處所使用之方法或過程步驟的組合可以任何順序執行。
本揭露之方法和組成物(包括其組分)可包含此處所描述之揭露內容的基本要素和限制，以及此處所描述或其他有用於營養組成物中之任何額外或可選擇之成分、組分或限制，或由這些所組成，或大致上由這些所組成。
此處所使用之“約”一詞應解釋為係指在任何範圍內之具體指明的數字。任何範圍之指稱應被視為對在該範圍內之任意子集提供支持。
本揭露之營養組成物可提供營養支持品給予早產和/或低出生體重嬰兒或給予任何其他營養需求未被滿足之患
者。於一些體系中，該營養組成物係經過設計以滿足個別個體(諸如嬰兒或早產兒)之特定營養需求，其為經標準化成具特定之卡路里含量的穩定、單位劑量液態組成物和/或為濃縮物以滿足個體之特別營養需要。
此外，本揭露提供有用於克服營養缺陷之組成物，其提供那些依賴部分或全腸外營養之個體營養素，從而促進個體之健康發展。確實，該營養組成物提供有效量之營養素，諸如DHA和/或ABA，其將促進例如嬰兒之視覺和神經系統發育。
本揭露亦提供用於經腸輸送營養素給予需要以非常小之體積投服該營養素之個體的方法。如此處所使用之經腸投服包括經由鼻胃管餵食、口胃管餵食、胃內灌食、經幽門投服或本技藝已知之用於將營養組成物直接引入消化道的任何其他方法。
因此，本揭露解決任何可能需要小體積之腸內營養支持品之群體的需求，包括，但不限於圍手術期個體、患有短腸綜合徵之個體、兒科重症照護個體、和/或無法完全經口餵食、或接受最少腸內營養支持品或TPN之任何年齡的任何群體。
具體而言，本揭露之營養組成物可提供嬰兒因各種狀況(諸如早產或外傷)而缺乏之有益營養素。這類營養素包括，但不限於二十二碳六烯酸、花生四烯酸、及任何其他水溶性或脂溶性營養素。
於至少一種體系中，本揭露針對可輸送一組小體積之
特定營養素給予個體的營養組成物。所產生之營養組成物為可在商品中存活且可實際用於重症照護設置中，包括，但不限於新生兒加護病房(NICU)。於一些體系中，本揭露之營養組成物包含經腸營養輸送系統，藉此可將小但精確體積之營養組成物引入個體之消化道中。於一些體系中，該營養組成物係以至少0.5毫升之體積劑量輸送。於某些體系中，該營養組成物係以約0.7至約1.3毫升之體積劑量輸送。於某些體系中，該營養組成物係以約1毫升之體積輸送。於另一體系中，該營養組成物係以至多約1.5毫升或至多約2毫升之體積輸送。
於一些體系中，該營養組成物以約1毫升之小體積液態劑量輸送珍貴之營養素給予早產嬰兒或嬰兒。雖然早產兒往往病重而無法承受經腸餵食，本揭露之營養組成物係經設計以可能透過例如置於新生兒加護病房中之嬰兒中的鼻胃管，以小體積營養補充劑直接投與嬰兒。因此，本揭露之營養組成物可在產後第一天開始投服。
此外，該營養組成物可每天投服一或兩次，或依醫療專業人員的指示更頻繁地投服。事實上，該營養組成物可能每天投服三次、每天投服四次，甚至依醫療專業人員的指示再更頻繁地投服。投服可能在出生後立即開始且可能持續下去，只要個體有營養需求。於一些體系中，係每日投與早產兒該營養組成物直到等於足月妊娠之時間。於其他體系中，投與個體該營養組成物的時間等於該患者接受全部或部分腸外營養之時間。
本揭露之營養組成物可能包含營養補充劑、人類母乳強化劑、嬰兒配方營養強化劑、或任何其他可食入之營養產品。此外，所揭露之營養組成物可能以本技藝已知之任何形式提供，諸如粉末、凝膠、懸浮液、糊狀物、固體、液體、液態濃縮物、可重構成之奶粉替代品、或即時可用之產品。於一些體系中，該營養組成物為適合經腸投服之液態營養補充劑。於其他體系中，該營養組成物為可能輕易地與人類母乳或嬰兒配方混合之液態營養強化劑。
該營養組成物可能包含含有脂肪或脂肪之組合物的脂質組分，以輸送所需之脂肪酸摻合物給予個體。用於實行本揭露之合適的脂肪或脂質來源可能包含本技藝已知之任何脂質來源，包括，但不限於：動物來源，例如乳脂肪、奶油、奶油脂肪、蛋黃脂質；海洋來源，諸如魚油、海洋油、單細胞油；蔬菜及植物油，諸如玉米油、菜籽油、葵花籽油、大豆油、棕櫚油(palmolein)、椰子油、高油酸葵花籽油、月見草油、菜籽油、橄欖油、亞麻籽(flaxseed)(亞麻子(linseed))油、棉籽油、高油酸紅花油、棕櫚硬脂、大豆卵磷脂、棕櫚仁油、小麥胚芽油、中鏈甘油三酯油。
於一些體系中，該營養組成物之脂質組分包含單一脂肪酸，諸如長鏈多不飽和脂肪酸(LCPUFA)或LCPUFAs之組合。LCPUFAs一般具有至少為18個碳之碳鏈長度。適合包含在營養組成物中之LCPUFAs包括，但不不限於ω-3或ω-6長鏈不飽和脂肪酸，諸如花生四烯酸(20：4n-
6)及二十二碳六烯酸(22：6 n-3)。於一種體系中，該脂質組分包含DHA。於其他體系中，該營養組成物之脂質組分包含DHA和ARA二者。納入該營養組成物中之DHA和ARA的較佳形式為游離、非酯化之DHA和ARA。
該脂質組分之全部或部分可能包含脂質乳液。於某些體系中，每100毫升營養組成物中可能包含約2.5至約5克之脂質組分。於一些體系中，該營養組成物可能包含約5至約20%重量/重量之脂質組分。
本揭露描述用於輸送各種油組成物之脂質乳液給予早產兒以滿足其必需脂肪酸之需求和能源之需求的組成物和方法。早產兒之一般疾病和不成熟的器官，以及減少之內源性必需脂肪酸的供給，使得必須在出生後不久就開始投服脂質乳液。於一些體系中，本揭露教示包含在脂質乳液中輸送之LCPUFAs(較佳為預先形成之DHA及ARA)的非藥學營養組成物。因此，該營養組成物解決未被滿足之營養需要，並支持早產兒的最佳生長和發育。
於一些體系中，該營養組成物之脂質組分可能包含約0.3%至約5%重量/重量之DHA。於一特殊之體系中，該脂質組分包含至少約0.32%之DHA。於其他體系中，該脂質組分包含至少約0.5%之DHA。於一些體系中，該脂質組分包含至少約1%之DHA。於進一步之體系中，該脂質組分包含至少約1.5%之DHA。再於其他體系中，該營養組成物之脂質組分包含至少約2%之DHA。該DHA之來源可能為本技藝已知之任何來源，諸如，例如海洋油、魚油
、單細胞油、蛋黃脂質及腦脂質。該DHA可為天然或精製形式。此外，於一體系中，該營養組成物包含含有DHASCO®和/或真菌油摻合物的DHA來源。
同樣地，於一些體系中，該營養組成物可經調製以輸送至少約25毫克/公斤/天之二十二碳六烯酸給予個體。於一些體系中，該營養組成物可經調製以輸送至少約50毫克/公斤/天之DHA。於其他體系中，該營養組成物可輸送至少約60毫克/公斤/天之DHA給予個體。且於一些體系中，該營養組成物可能經調製以輸送至少約75毫克/公斤/天之二十二碳六烯酸給予個體。於進一步之體系中，該營養組成物係經調製以輸送至少約100毫克/公斤/天之DHA。那麼，因此，由於許多早產兒之體重係介於約500克與2000克之間，該營養組成物可能經調製以輸送，例如每天約12毫克至200毫克之DHA。於一些體系中，每100毫升該營養組成物中將包含約12至約200毫克之DHA。
該營養組成物之脂質組分可能包含約0.5%至約5%重量/重量之ARA。於一體系中，該脂質組分包含至少約0.64%之ARA。於其他體系中，該脂質組分包含至少約0.5%之ARA。於一些體系中，該脂質組分包含至少約1%之ARA。於進一步之體系中，該脂質組分包含至少約1.5%之ARA。再於其他體系中，該營養組成物之脂質組分包含至少約2%之ARA。該ARA之來源可能為本技藝已知之任何ARA之來源。於一些體系中，該營養組成物包含含有ARASCO®和/或真菌油摻合物之ARA來源。於一
些體系中，該營養補充劑之ARA組分包含約30%之真菌油摻合物。
該營養組成物可經調製以輸送至少約10毫克/公斤/天之花生四烯酸給予個體。於一些體系中，該營養組成物可經調製以輸送至少約15毫克/公斤/天之花生四烯酸給予個體。於一些體系中，該營養組成物可能經調製以輸送至少約25毫克/公斤/天之花生四烯酸給予個體。於一些體系中，該營養組成物可能經調製以輸送至少約40毫克/公斤/天之ARA。於其他體系中，該營養組成物可輸送至少約50毫克/公斤/天之ARA給予個體。且於一些體系中，該營養組成物可能經調製以輸送至少約60毫克/公斤/天之ARA給予個體。那麼，因此，由於許多早產兒之體重係介於約500克與2000克之間，該營養組成物可經調製以輸送例如：每天約12毫克至120毫克之ARA。
該營養組成物可同時輔以DHA和ARA作為脂質組分之一部分。於一些體系中，該DHA：ARA比係介於約1：6和6：1之間。於其他體系中，該DHA：ARA比係介於約1：2和2：1之間。再於進一步之體系，該DHA：ARA比為約1：1。再於其他體系中，該DHA：ARA比為約3：1至約1：9。
於一些體系中，該營養組成物進一步包含蛋白質組分。該蛋白質組分可能包含，但不限於乳蛋白粉、乳蛋白濃縮物、乳蛋白分離物、脫脂乳固體、脫脂乳、脫脂奶粉、乳清蛋白、乳清蛋白分離物、乳清蛋白濃縮物、甜乳清、
酸乳清、酪蛋白、酸酪蛋白、酪蛋白酸化物(如：酪蛋白酸鈉、酪蛋白酸鈉鈣、酪蛋白酸鈣)及彼等之任何組合。
於一體系中，該蛋白質係以完整蛋白質之形式提供。於其他體系中，該蛋白質係以完整蛋白質與部分水解之蛋白(水解程度介於約4%至10%之間)兩者的組合物之形式提供。於某些其他體系中，該蛋白質被更完全地水解。再於另一體系中，該蛋白質來源可輔以含有麩醯胺之肽類。
於一些體系中，該營養組成物包含碳水化合物組分。根據用途，該營養組成物中所利用之碳水化合物可能為任何可消化之碳水化合物，諸如右旋糖、果糖、蔗糖、麥芽糖、麥芽糊精、玉米糖漿固體、或彼等之混合物。由於其容易消化，經水解或部分水解之蛋白質和/或碳水化合物可能是令人滿意的。此外，該營養組成物亦可能包含除了已確認之胺基酸和蛋白質外之額外的氮源。
該營養組成物可能包括維生素及礦物質組分。該維生素和礦物組分可能選擇性地包括，但不限於一或多種下列礦物質或彼等之衍生物：硼、鈣、醋酸鈣、葡萄糖酸鈣、氯化鈣、乳酸鈣、磷酸鈣、硫酸鈣、氯化物、鉻、氯化鉻、吡啶甲酸鉻(chromium picolonate)、銅、硫酸銅、葡萄糖酸銅、硫酸銅、氟化物、鐵、羰基鐵、三價鐵、富馬酸亞鐵、正磷酸鐵、硏製鐵、多醣鐵、碘化物、碘、鎂、碳酸鎂、氫氧化鎂、氧化鎂、硬脂酸鎂、硫酸鎂、錳、鉬、磷、鉀、磷酸鉀、碘化鉀、氯化鉀、醋酸鉀、硒、硫、
鈉、多庫酯鈉、氯化鈉、硒酸鈉、鉬酸鈉、鋅、氧化鋅、硫酸鋅及彼等之混合物。無機化合物之非限制性示範性衍生物包括任何無機化合物之鹽、鹼鹽、酯及螯合物。
該礦物質可以鹽類形式添加在營養產品中，該礦物質之鹽類為，諸如磷酸鈣、磷酸甘油鈣、檸檬酸鈉、氯化鉀、磷酸鉀、磷酸鎂、硫酸亞鐵、硫酸鋅、硫酸銅、硫酸錳及亞硒酸鈉。其他維生素及礦物質可依本技藝中所已知者添加。
該營養組成物之維生素組分可能選擇性地包括，但不限於一或多種下列維生素或其衍生物：維生素B1(硫胺素、焦磷酸硫胺素、TPP、三磷酸硫胺素、TTP、鹽酸硫胺素、單硝酸硫胺素)、維生素B2(核黃素、黃素單核苷酸、FMN、黃素腺嘌呤二核苷酸、FAD、乳黃素、卵黃素)、維生素B3(菸鹼酸(niacin)、菸鹼酸(nicotinic acid)、菸醯胺(nicotinamide)、菸醯胺(niacinamide)、菸醯胺腺嘌呤二核苷酸、NAD、菸鹼酸單核苷酸、NicMN、吡啶-3-羧酸)、維生素B3先質色胺酸、維生素B6(吡哆醇、吡哆醛、吡哆胺、鹽酸吡哆醇)、泛酸(泛酸鹽、泛醇)、葉酸鹽(葉酸(folic acid)、葉酸(folacin)、蝶麩胺酸)、維生素B12(鈷胺素、甲基鈷胺素、去氧腺苷鈷胺素、氰鈷胺素、羥基鈷胺素、腺苷鈷胺素)、生物素、維生素C(抗壞血酸)、維生素A(視黃醇、視黃醇醋酸酯、視黃醇棕櫚酸酯、具其他長鏈脂肪酸之視黃酯、視黃醛、視黃酸、視黃醇酯)
、維生素D(骨化醇、膽骨化醇、維生素D3、1,25-二羥基維生素D)、維生素E(α-生育酚、α-生育酚醋酸酯、α-生育酚琥珀酸酯、α-生育酚菸鹼酸酯、γ-生育酚)、維生素K(維生素K1、葉綠醌、萘醌、維生素K2、甲萘醌-7、維生素K3、甲萘醌-4、甲萘醌、甲萘醌-8、甲萘醌-8H、甲萘醌-9、甲萘醌-9H、甲萘醌-10、甲萘醌-11、甲萘醌-12、甲萘醌-13)、膽鹼、肌醇、β-胡蘿蔔素及彼等之任何組合。
於某些體系中，本揭露之營養組成物可能包含至少一種益菌素。在此體系中，可能添加任何本技藝中已知之益菌素。於一特定之體系中，該益菌素可選自下列群組：果寡糖、葡萄寡醣、半乳寡糖、聚右旋糖、異麥芽寡醣、木寡糖及乳果糖。
於本揭露之某些體系中，該營養組成物可能包含一或多種益生菌。本技藝中已知之任何益生菌均可被本體系所接受，其先決條件為其可達到所欲結果。於一特定之體系中，該益生菌可能選自任何乳桿菌種、鼠李糖乳桿菌GG(Lactobacillus rhamnosus GG)(美國標準菌種培養保存中心編號ATCC 53103)、雙歧桿菌種、龍根菌(Bifidobacterium longum)、及動物雙歧桿菌乳BB-12亞種(Bifidobacterium animalis subsp.lactis BB-12)(DSM 10140號)或彼等之組合。
於一體系中，該益生菌可能為可存活，或非可存活的。此處所使用之“可存活的”一詞係指活的微生物。
“非可存活的”或“非可存活的益生菌”一詞係指非存活的益生菌微生物、彼之細胞組分和/或其代謝物。這類非可存活之益生菌可能已經熱滅殺或滅活，但他們仍保留有利地影響宿主健康的能力。有用於本揭露之益生菌可能為天然產生、合成或透過生物體之遺傳操縱發展出，不論這類新來源是現在已知或稍後開發的。
本技藝已知許多配方由於脫水收縮及形成非可分散之沉積物而容易發生物理不穩定。不穩定性係由已知之營養配方中包含之高水準之蛋白質、脂肪和礦物質所造成，該高水準之蛋白質、脂肪和礦物質係用於提供在合理體積內之足夠營養。値得注意的是，傳統的經腸配方酸化亦可能導致蛋白質沉澱及相分離。沉澱之營養素通常不能被動搖回到溶液中，且其不提供促進個體健康所需之營養利益。
然而，本揭露之營養組成物包含進一步包含乳化劑之穩定乳液。該乳化劑可能包含顯微密封劑、表面活性劑、乳液穩定劑、或彼等之組合。於一些體系中，該乳化劑可能包含例如：卵磷脂、單甘油酯或二甘油酯。於一些體系中，該營養組成物之脂質組分提供為穩定之乳液形式的脂肪酸。於其他體系中，該營養組成物可能包含穩定劑，諸如卡拉膠，以取代乳化劑，或除了乳化劑外再另外添加。
於一些體系中，該乳化步驟可能經由機械攪拌、超聲波振動、加熱、或彼等之組合完成。乳化可能使用本技藝已知之任何用於乳化的方法來完成。於一體系中，乳化可能包含均化。於一些體系中，可應用數個均化步驟來產生
該營養組成物之乳化的脂質組分。
於該穩定乳液之一些體系中，蛋白質可能作為表面活性劑。蛋白質表面活性劑具有在脂質-水界面散佈的能力，以減少液滴聚結。確實，蛋白質表面活性劑可能降低兩種液體之間的界面張力而產生該兩種液體之可溶混性。該營養組成物可能包含任何水溶性乳化劑。於一些體系中，該營養組成物可能包含一種以上之乳化劑和/或穩定劑。
於一體系中，該組成物包含至少一種LCPUFA之乳液，其係藉由包含α-乳白蛋白之蛋白質基質穩定。該乳化之LCPUFA可能包含DHA。該α-乳白蛋白作為穩定劑，具體地說，作為表面活性劑。在脂質組分中可能使用額外之表面活性劑、乳液穩定劑及顯微密封劑，但非必要，以產生本揭露之營養組成物的穩定乳液。於一些體系中，該營養組成物之脂質乳液包含直徑約0.070微米至約1微米之油/脂液滴。
再者，該營養組成物之一些體系，諸如那些對早產兒或重症嬰兒最理想者可能模擬某些人類母乳之某些特徵。確實，該營養配方可能包含α-乳白蛋白，其為人類母乳中之主要乳清蛋白。在用於早產兒之組成物中添加α-乳白蛋白可能提供數種生理及營養利益。然而，為了滿足早產兒之特殊DHA需求，該營養組成物包含較人類母乳為高之DHA含量。該營養組成物中增加之DHA水準可彌補早產兒中之任何DHA不足和/或防止出現DHA不足。
乳液之液相或水性元素中可能納入其他營養素和成分
，諸如胺基酸、維生素及礦物質。將這類其他成分在均化後藉由混合入該乳液來直接添加到乳液中可能是有利的。確實，該穩定之乳液允許其他營養素被納入水性元素中，而不會將該脂質液滴去吸附、瓦解或合倂。
再者，於一些體系中，該包含乳液之營養組成物為營養完整的，其含有合適類型及合適量之脂質、碳水化合物、蛋白質、維生素和礦物質以作為個體之唯一營養來源。確實，該營養組成物可選擇性地包含任何數量之蛋白質、肽、胺基酸、脂肪酸、益生菌和/或其代謝副產物、益菌素、碳水化合物及任何可提供個體許多營養及生理益處的其他營養素或其他化合物。此外，本揭露之營養組成物可能包含香料、增味劑、甜味劑、色素、維生素、礦物質、治療成分、功能性食品成分、食品成分、加工成分或彼等之組合。
本揭露進一步提供用於提供個體，諸如早產兒營養支持品的方法，也就是接受部分或全腸外營養。該方法包括投與該個體有效量之本揭露的營養組成物。投服期間可能會有所不同，但該營養組成物應在嬰兒無法完全進食和/或接受完全或部分全腸外營養時投服。
本揭露之營養組成物可能經商業包裝從而使其可能與腸道營養裝置(包括，但不限於鼻餵管、經皮內視鏡胃造口、經皮內視鏡空腸造口、經幽門管，等)直接接合。然而，該包裝應該與靜脈內餵食管不相容，以將靜脈內投服的風險降至最低。這類設計可方便確保完整輸送該包裝內
容，以將污染的風險降至最低，並增加適應性。再者，於某些體系中，該營養組成物可被包裝在總體積為約1毫升、總體積為約1.5毫升、或總體積為約2毫升之單一單位劑量輸送包內。單位劑量包裝系統為較佳者以將用藥錯誤減至最少並減少污染的風險。
該營養組成物可能被直接排入個體之小腸道。於一些體系中，該營養組成物可能被直接排入腸道。於一些體系中，該組成物係經調製成在醫生之監督下服用或經腸投服且可能用於疾病或病況的特定飲食管理中，該獨特之營養需求係根據公認的科學原則藉由醫療評估建立。
本揭露之營養組成物不限於包含此處具體列出之營養素的組成物。任何營養素均可能以組成物之一部分的形式輸送以符合個體之營養需要和/或將個體之營養狀態最優化。
於一些體系中，該營養組成物可能從嬰兒出生起開始輸送直到符合妊娠足月。於一些體系中，該營養組成物可能從嬰兒出生起開始輸送直到至少約3個月矯正年齡。於另一體系中，只要必須矯正營養缺陷時，可將該營養組成物輸送給個體。再於另一體系中，該營養組成物可能從嬰兒出生起開始輸送直到至少約一歲之矯正年齡。
本揭露之營養組成物可能經標準化成特定之卡路里含量，其可以即時可用之產品形式提供，或者其可以濃縮形式提供。
本揭露提供用於腸道投服之營養補充劑，其包含含有
至少一種脂肪酸之乳液的脂質組成物，其中該營養補充劑係設計成用來矯正個體(諸如早產兒)之營養缺陷，其係藉由增加個體之營養素(諸如ω-3或ω-6長鏈多不飽和脂肪酸)攝取。
於一些體系中，該營養組成物為人類母乳營養強化劑和/或嬰兒配方營養強化劑。於這類體系中，該營養組成物包含為可以輕易地與人類母乳或嬰兒配方混合之穩定乳液形式的DHA和ARA。作為從腸外營養支持品轉移成經口營養品(嬰兒配方或人類母乳)加上部分/外營養支持品之組合物的嬰兒過渡營養品，可將該為營養強化劑形式之營養組成物添加到經口營養品中以盡力確保具有充足水準之DHA和ARA來支持個體之最佳生長及神經發育。
本揭露之營養組成物和方法經由解決並矯正現有產品中之營養缺陷而提供較先前技藝顯著之優點。此外，本揭露之營養組成物提供早產兒寶貴的營養素，當該早產兒依賴現有來源之TPN時將無法接受這類營養素。
下列實例係用於說明本揭露之營養組成物的一些體系，但不應被理解為就本揭露提出任何限制。熟習本技藝之人士考量此處所揭露之營養組成物或方法的專利說明書或練習時將可清楚明白在此處之申請專利範圍內的其他體系。本專利說明書與該實例係僅欲作為示範，本揭露之範圍和精神係由接續在實例後之申請專利範圍指明。
於一體系中，本揭露之營養組成物可經調製以每日投與體重約1公斤之嬰兒兩次。該嬰兒可能接受兩份1.5毫升之營養組成物。該營養組成物可經調製以輸送約25.5毫克/天之DHA及約17毫克/天之ARA給予嬰兒。適合用於本實例中之營養組成物的實例載列如下：
營養組成物1 
此外，於另一體系中，該營養組成物可以每份約1.5毫升之量每天投與嬰兒四次。該營養組成物可經調製以輸送約25.5毫克/天之DHA及約17毫克/天之ARA給予嬰兒。適合用於本實例中之營養組成物的實例載列如下：
營養組成物2 
所有本專利說明書中引用之參考資料，包括，但不限
於所有論文、出版物、專利、專利申請案、演示、文本、報告、手稿、小冊子、書籍、網路貼文、期刊文章、期刊，等之全部內容均納為本專利說明書之參考。本文中該參考資料之討論僅欲摘要其作者之主張，而非承認任何參考資料構成先前技藝。本申請者保留對所引用之參考資料的準確性和相關性提出異議的權利。
雖然本揭露之體系已使用特定術語、設備和方法描述，這類描述僅用於解說。所使用之用語為描述用語，而非限制用語。可以理解的是，本技藝之一般技術人士可做些修改及變化，而不偏離載列於後之申請專利範圍中的本揭露之精神或範圍。此外，應理解的是，各種體系之面向可能全部或部分互換。例如，雖然用於製造根據那些方法而製做的無菌液態營養補充劑商品的方法已有示範，其他用途亦在設想內。因此，所附之申請專利範圍的精神和範圍不應只限於其中所載之較佳版本的描述。
Claims (10)
- 一種用於提供營養支持予接受腸胃道外營養之早產兒之非治療性方法，該方法包含：經腸投予該早產兒具有0.5至2ml的體積劑量之營養補充劑，該營養補充劑包含：以該營養補充劑之總重量為基礎的2至20重量%之脂質組分，其中該脂質組分包含至少約0.5重量%之花生四烯酸及至少約1重量%之二十二碳六烯酸，其中該花生四烯酸及二十二碳六烯酸係以乳化形式提供。
- 如申請專利範圍第1項之方法，其中該脂質組分包含至少約2重量%之二十二碳六烯酸。
- 如申請專利範圍第1項之方法，其中該營養補充劑係經調製以輸送至少約50毫克/公斤/天之二十二碳六烯酸。
- 如申請專利範圍第1項之方法，其中該營養補充劑係經調製以輸送至少約60毫克/公斤/天之二十二碳六烯酸。
- 如申請專利範圍第1項之方法，其中該營養補充劑係經調製以輸送至少約40毫克/公斤/天之花生四烯酸。
- 如申請專利範圍第1項之方法，該營養補充劑進一步包含蛋白質組分。
- 如申請專利範圍第1項之方法，該營養補充劑進一步包含碳水化合物組分。
- 如申請專利範圍第1項之方法，該營養補充劑進 一步包含維生素及礦物質組分。
- 如申請專利範圍第1項之方法，該營養補充劑進一步包含至少一種益生菌。
- 如申請專利範圍第1項之方法，該營養補充劑進一步包含至少一種益菌素。
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| CN101299934B (zh) | 2005-10-05 | 2012-08-08 | 雀巢技术公司 | 用于促进追赶生长的营养制剂 |
| US20080003329A1 (en) * | 2006-06-30 | 2008-01-03 | Ricardo Rueda | Enriched infant formulas |
| CN101259101B (zh) | 2008-04-17 | 2010-06-02 | 湖北福星生物科技有限公司 | 微米级花生四烯酸和二十二碳六烯酸乳状液及其制备方法 |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20060286205A1 (en) * | 2005-05-12 | 2006-12-21 | Martek Biosciences Corporation | Biomass hydrolysate and uses and production thereof |
| TW201026239A (en) * | 2008-09-19 | 2010-07-16 | Mead Johnson Nutrition Co | Probiotic infant products |
| WO2010134800A1 (en) * | 2009-05-19 | 2010-11-25 | N.V. Nutricia | Human milk fortifier with high protein and long chain poly unsaturated fatty acids for improving body adipose tissue distribution |
Also Published As
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|---|---|
| WO2012078358A1 (en) | 2012-06-14 |
| CA2820790C (en) | 2019-04-09 |
| EP2648549B1 (en) | 2019-07-31 |
| CN103327834A (zh) | 2013-09-25 |
| MX2013005023A (es) | 2013-08-29 |
| RU2013124962A (ru) | 2015-01-20 |
| PE20141022A1 (es) | 2014-09-14 |
| MX342391B (es) | 2016-09-28 |
| US9375028B2 (en) | 2016-06-28 |
| CA2820790A1 (en) | 2012-06-14 |
| CO6761393A2 (es) | 2013-09-30 |
| TW201234981A (en) | 2012-09-01 |
| ES2752076T3 (es) | 2020-04-02 |
| US20120149774A1 (en) | 2012-06-14 |
| BR112013012843A2 (pt) | 2016-07-19 |
| ECSP13012741A (es) | 2013-09-30 |
| EP2648549A1 (en) | 2013-10-16 |
| MY169302A (en) | 2019-03-21 |
| SG190096A1 (en) | 2013-06-28 |
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