TW201536192A - 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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- TW201536192A TW201536192A TW103119369A TW103119369A TW201536192A TW 201536192 A TW201536192 A TW 201536192A TW 103119369 A TW103119369 A TW 103119369A TW 103119369 A TW103119369 A TW 103119369A TW 201536192 A TW201536192 A TW 201536192A
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
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- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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Abstract
本發明提供包含二十二碳六烯酸(DHA)及花生四烯酸(ARA)之營養組成物。該營養組成物可包含二十二碳六烯酸(DHA)及花生四烯酸(ARA)之乳劑，且適合用於腸內輸送以作為營養補充劑或用於口服輸送以作為母乳或嬰兒配方強化劑。此外，本發明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)的方法。該營養組成物可用於，例如經由增加個體之營養素(諸如ω-3或ω-6長鏈多不飽和酸)來矯正營養不足。
Description
本申請案為2010年12月9日提交，題目為“用於營養素輸送之組成物和方法”之待審的美國專利申請案第12/963,762號(其以引用方式被納入本文)的連續申請案。
本發明關於包含二十二碳六烯酸(“DHA”)及花生四烯酸(“ARA”)之改善的腸內營養組成物，亦關於用於提供穩定之乳劑形式的營養支持品給苦於營養不足之個體族群(諸如早產兒及/或低出生體重兒)的方法。本發明之液態營養組成物可含有分散在水性組分中之DHA及/或ARA的乳劑。
該營養組成物可適合用於經由鼻胃管、胃內餵食、經幽門投予的腸內輸送及/或任何其他導致將營養組成物直接引入個體之消化道的投予方式。
本發明關於改善之腸內營養組成物，其解決生病族群之營養不足症及其他常由這些缺陷造成之生理後
果。尤其是，本發明解決可能出現在早產兒及/或低出生體重兒中之營養不足問題。
由於短期生存及長期的成長和發育受到威脅，營養支持對於早產兒非常重要。提供營養支持給早產兒的重要目標包括促進生長率和營養增加，從而將神經發育的結果最優化並奠定長期健康的雄厚基礎。由於早產兒往往情況危重且因為多種因素(包括伴隨的異常狀態、不成熟的腸胃系統及其他不成熟的器官系統)而不能耐受傳統的腸內餵食，這些目標在低出生體重兒中並不容易達成。
通常，全靜脈營養療法(“TPN”)被指為是提供早產兒營養支持之惟一或較佳的方法。然而，雖然TPN可拯救生命，但其並非營養支持的完美方式。傳統上，以TPN攝生法之一部分的形式投予之營養組成物缺乏許多重要的營養素，這可能會引起早產兒之長期生理和發育後果。
低出生體重和極低出生體重兒特別容易受出生後生長障礙和營養不足影響。然而，TPN無法充分提供有價值的營養素，諸如DHA和ARA。因此，許多早產兒並未接受充足之DHA或ARA供應。
在進食正常飲食(其中提供充足之DHA和ARA)的健康個體中，通常不需要補充DHA或ARA。食用一定量的DHA和ARA對嬰兒是重要的，因為在子宮內和出生後之生長期間有相當大量的DHA和ARA沉積在人的
大腦和其他組織中。(Clandinin MT等人，Requirements of newborn infants for long chain polyunsaturated fatty acids.Acta Paediatr Scand 1989；351 Suppl：63-71。)事實上，由於胎盤提供胎兒DHA和ARA，在懷孕的最後三個月期間，胎兒累積長鏈多不飽和脂肪酸(“LCPUFA”)，諸如DHA及ARA。(A.Lapitlonne等人，Reevaluation of the DHA requirement for the premature infant.Prostaglandins,Leukotrienes and Essential Fatty Acids 81(2009)143-150。)但在早產的情況中，嬰兒面臨胎盤LCPUFA之供應突然中斷。因此，早產兒可能迅速耗盡其可用之LCPUFA存貨，而嬰兒愈早產所造成之LCPUFA不足愈嚴重。
由於早產兒的腸胃不成熟、營養素儲存差且對支持生長之營養素的需求高，滿足早產兒的營養需求是有問題的。(L.G.Smithers等人，Effect of two doses of docosahexaenoic acid 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，在情況危重的早產兒中，必需脂肪酸及其衍生物供應不足似乎可能導致視覺功能及神經發育長期損傷。(D.Driscoll等人，Pharmaceutical and clinical aspects of parenteral lipid emulsions in neonatology.Clinical Nutrition(2008)27,497-503。)這些問題因腸胃道外及TPN營養組成物中缺乏LCPUFA(諸如DHA及ARA)存在而加劇。
實際上，目前在市場上之TPN及其他腸胃道外營養補充劑最多僅提供可忽略不計之預製的DHA和ARA。DHA為ω-3脂肪酸且為大腦和視網膜中含量最豐富之LCPUFA，其被認為對嬰兒大腦和視覺之正常發育是必要的。雖然存有從飲食亞麻酸生物合成的代謝途徑，該途徑為生物能量上不利的且哺乳動物所取得之DHA大部分係從飲食來源所提供之預先形成的DHA取得。因而，對嬰兒而言，DHA之來源通常為母乳；然而，提供給早產兒之腸胃道外配方通常不含DHA。
腸胃道外配方通常亦無法提供足量之ARA。ARA為ω-6 LCPUFA，其為血液、肝臟、肌肉及其他主要器官系統中與磷脂相關的結構性脂質的主要部分。ARA係經由將亞油酸拉長及飽和來合成。然而，大多數ARA必須在飲食中提供。ARA在身體快速生長期間尤其重要，因此，為嬰兒營養的重要組分。
許多研究指出提供給嬰兒之未經補充的早產兒乳品所提供之數種必要營養素的量不足以滿足早產兒(Davis,D.P.,"Adequacy of expressed breast milk for early growth of preterm infants",Archives of Disease in Childhood，52，296-301頁，1997)。由於活動力、能量消耗、營養素之吸收效率、疾病及組織合成時利用能量之能力的差異，嬰兒之間的確切需求有所不同，目前可用之胃腸道外營養來源是不足的。
再者，早產兒往往無法良好耐受餵食體積且
營養素必須以可接受之體積提供(通常係經由腸內投予)。用於早產兒之腸內餵食的適當方法係根據胎齡、出生體重、臨床狀況及負責之醫療人員的意見。特殊之餵養決定係基於嬰兒協調吸吮、吞嚥及呼吸能力。往往，較不成熟、虛弱或情況危重之早產兒或嬰兒需要藉由管飼以避免吸入之風險並節省能量。
鼻胃管餵食通常用於新生兒加護病房且可藉由大量輸注或連續輸注強化之母乳或其他營養補充劑來完成。極低出生體重兒及先前無法耐受大量餵食之嬰兒對連續餵食可有較好之耐受性；然而，如前文所討論者，減少或缺乏營養素輸送為本技藝中已知之與連續餵食法有關的問題。
因此，本技藝中對於提供包含支持嬰兒發育之有價值的營養素(諸如DHA和ARA)的營養組成物存有需求。因此，本發明之營養組成物和方法提供腸內營養支持給苦於營養不足之個體以促進最理想之健康和發育。本發明之營養組成物輸送那些在胃腸道外營養組成物及其他嬰兒配方中不存在或提供量不足的重要營養素。
因此，簡言地說，本發明針對用於解決個體(諸如需要小體積之營養支持的早產兒)中之營養不足的穩定營養組成物及用於促進這些個體健康發育的方法。本發明提供用於投予個體脂肪酸(諸如DHA及/或ARA)及其他
營養素，以防止發展出營養不足及/或矯正現有之營養不足的組成物。
於一實施態樣中，本發明包含含有DHA及/或ARA之乳劑的營養組成物。於一些實施態樣中，該營養組成物適合用於兒科個體中之腸內投予。
而另一實施態樣包含含有DHA及/或ARA之營養補充劑，此營養補充劑係用於強化母乳或適合經口投予之嬰兒配方。
於另一實施態樣中，本發明包含用於提供個體營養支持之方法，該方法包含投予個體包含DHA及/或ARA之乳劑的營養組成物。
應理解的是，前文之一般描述及以下本發明之實施態樣的詳細描述皆旨在提供用於理解本發明所申請專利之性質及特性的概述或架構。該描述係用於解釋申請專利之標的物的原理和操作。熟習本技藝之人士在閱讀以下之揭露內容後將可輕易地明白本發明之其他和進一步特徵及優點。
本發明提供用於提供營養支持之營養組成物及方法。該營養組成物包含含有DHA及ARA之脂質組分且適合用於輸送給苦於營養不足之個體，諸如早產兒。本發明進一步提供用於添加在母乳或嬰兒配方中之改善的強化劑。該強化劑包含DHA和ARA之穩定乳劑。本發明還
進一步提供用於提供個體(諸如早產兒)營養支持的方法。本發明之完整且有利之揭示內容，包括其針對本技藝之一般技術人士的最佳模式說明於以下之專利說明書中。
以下，“腸內投予”包括，但不限於經由鼻胃管、口胃餵食、胃內餵食或經幽門投予之餵食。“腸內投予”亦可包括本技藝中已知之任何其他用於將營養組成物直接導入消化道，而不經口餵食的方法。
短語“營養組成物”包括營養補充劑、母乳強化劑、嬰兒配方強化劑及類似物，但並不限於這些。本發明之營養組成物可適合用於腸內投予或口服投予。
“早產兒”意指在妊娠第37週前出生的個體。短語“早產兒”可與短語“早熟兒”互換使用。
“低出生體重兒”係指出生體重低於2500克(約5磅8盎司)之嬰兒。
“非常低出生體重兒”係指出生體重低於1500克(約3磅4盎司)之嬰兒。
“極低出生體重兒”係指出生體重低於1000公克(約2磅3盎司)之嬰兒。
“嬰兒”係指年齡在出生到不超過一歲之範圍內的人個體且包括0至12個月矯正年齡之嬰兒。短語“矯正年齡”意指嬰兒之實足年齡減去嬰兒早產的時間量。因此，嬰兒若足月出生則矯正年齡為嬰兒的年齡。術語嬰兒包括低出生體重嬰兒、非常低出生體重嬰兒及早產兒。
“乳劑”意指包含分散相和連續相之二或多種不
相溶混之液體的混合物。在乳劑中，稱為分散相的液體被分散在另一稱為連續相、本體相或水性組分的液體中。
“單位劑量”係指營養組成物之單一包裝。
除非另有規定，本文所使用之所有百分比、份數及比例係按總組成物之重量計。
本發明之營養組成物亦可實質上不含任何本文所描述之可選擇或選定之成分，惟該其餘的營養組成物仍含有所有本文所描述之必要成分或特性。在此背景下，除非另外具體指明，術語“實質上不含”意指該選定之組成物所含有之可選擇的成分可能少於該成分之功能量，通常少於0.1重量%，且亦包括0重量%之這類可選擇或選定之成分。
除非另外具體指明或明確暗示與所引用之背景相反，本發明中對單數特性或限制之所有引用應包括該對應之複數特性或限制，反之亦然。
除非另外具體指明或明確暗示與所引用之組合的背景相反，本文所使用之所有方法或加工步驟的組合可以以任何順序執行。
本發明之方法和組成物(包括其組分)可包含此處所描述之揭示內容的必須要素和限制，以及本文所描述或可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，由上述彼等所組成或實質上由上述彼等所組成。
如本文所使用之術語“約”應解釋為係指被具體指定之兩個數字內的任何範圍。對範圍之任何引用應被
認為係提供對該範圍內之任何子集的支持。
本發明之營養組成物可提供早產兒及/或低出生體重兒、或任何其他營養需求未被滿足之患者營養支持。於一些實施態樣中，該營養組成物係經過設計以在被標準化成具有特定之卡路里含量的穩定、單位劑量液體組成物中滿足個別個體(諸如嬰兒或早產兒)之特定營養需求及/或為濃縮物之形式，以滿足個體之特定營養需求。
此外，本發明提供用於打擊營養不足之營養組成物，以提供營養素予那些倚賴部分或全靜脈營養療法的個體，從而促進個體之健康發育。實際上，該營養組成物提供有效量之營養素，諸如DHA或ARA，此有效量之營養素將能促進，例如嬰兒之視覺和神經發育。
於一些實施態樣中，該營養組成物之脂質組分包含單一脂肪酸，諸如LCPUFA或多種LCPUFA之組合。LCPUFA一般具有長度為至少18個碳原子的碳鏈。用於包含在營養組成物中之合適的LCPUFA包括，但不限於ω-3或ω-6長鏈多不飽和脂肪酸，諸如ARA(20：4n-6)及DHA(22：6n-3)。於一實施態樣中，該脂質組分包含DHA。於其他實施態樣中，該營養組成物之脂質組分包含DHA及ARA二者。被納入營養組成物中之較佳的DHA和ARA形式為游離、非酯化之DHA和ARA。
於一些實施態樣中，該營養組成物之脂質組分可包含約0.3%至約5%重量/重量之DHA。於一特定之實施態樣中，該脂質組分包含至少約0.32%之DHA。於其
他實施態樣中，該脂質組分包含至少約0.5%之DHA。於一些實施態樣中，該脂質組分包含至少約1%之DHA。於進一步之實施態樣中，該脂質組分包含至少約1.5%之DHA。再於其他實施態樣中，該營養組成物之脂質組分包含至少約2%之DHA。
於一些實施態樣中，DHA可構成總脂質組分之約15%至30%重量/重量。於其他實施態樣中，DHA構成該脂質組分之至少約20%至約30%重量/重量。再於進一步之實施態樣中，DHA構成該脂質組分之至少約20%重量/重量。再於其他實施態樣中，DHA構成該脂質組分之28%重量/重量。實際上，本發明之脂質組分可被配製成具有較本技藝普遍所知者來得多或少的DHA量。以較多量之DHA配製的營養組成物可提供額外及/或協同之健康益處。
DHA之來源可為本技藝中已知之任何來源，諸如，例如海洋生物油、魚油、單細胞油、蛋黃脂質及腦脂質。DHA可為天然或精製形式。此外，於一實施態樣中，該營養組成物包含含有DHASCO®及/或真菌油摻合物之DHA來源。於一些實施態樣中，該營養組成物包含含有LIPIL油之DHA來源。
同樣地，於一些實施態樣中，該營養組成物可經配製以輸送至少約25毫克/公斤/天之DHA給個體。於一些實施態樣中，該營養組成物可經配製以輸送至少約50毫克/公斤/天之DHA。於其他實施態樣中，該營養組成
物可輸送至少約60毫克/公斤/天之DHA給個體。而於一些實施態樣中，該營養組成物可經配製以輸送至少約75毫克/公斤/天之DHA給個體。於進一步之實施態樣中，該營養組成物係經配製以輸送至少約100毫克/公斤/天之DHA。因此，然後，由於許多早產兒體重在約500克至2000克之間，該營養組成物可被配製成每天輸送，例如約12毫克至200毫克之DHA。於一些實施態樣中，每100毫升該營養組成物將包含約12至約200毫克之DHA。
該營養組成物之脂質組分可包含約0.5%至約5%重量/重量之ARA。於一實施態樣中，該脂質組分包含至少約0.64%之ARA。於其他實施態樣中，該脂質組分包含至少約0.5%之ARA。於一些實施態樣中，該脂質組分包含至少約1%之ARA。於進一步之實施態樣中，該脂質組分包含至少約1.5%之ARA。再於其他實施態樣中，該營養組成物之脂質組分包含至少約2%之ARA。
於一些實施態樣中，ARA可構成總脂質組分之約10%至約20%重量/重量。於其他實施態樣中，ARA可構成總脂質組分之至少約15%重量/重量。於其他實施態樣中，ARA可構成總脂質組分之約14%重量/重量。
該ARA來源可為本技藝中已知之任何ARA來源。於一些實施態樣中，該營養組成物包含含有ARASCO®及/或真菌油摻合物之ARA來源。於一些實施態樣中，該營養補充劑之ARA組分包含約30%之真菌油摻
合物。於其他實施態樣中，該營養組成物包含含有LIPIL油之ARA來源。
該營養組成物可經配製以輸送至少約10毫克/公斤/天之ARA給個體。於一些實施態樣中，該營養組成物可經配製以輸送至少約15毫克/公斤/天之ARA給個體。於一些實施態樣中，該營養組成物可經配製以輸送至少約25毫克/公斤/天之ARA給個體。於一些實施態樣中，該營養組成物可經配製以輸送至少約40毫克/公斤/天之ARA。於其他實施態樣中，該營養組成物可輸送至少約50毫克/公斤/天之ARA給個體。而於一些實施態樣中，該營養組成物可經配製以輸送至少約60毫克/公斤/天之ARA給個體。因此，然後，由於許多早產兒體重在約500克至2000克之間，該營養組成物可被配製成每天輸送，例如約12毫克至120毫克之ARA。
該營養組成物之脂質組分可輔以DHA和ARA二者。於一些實施態樣中，該DHA：ARA之比例係介於約1：6和6：1之間。於其他實施態樣中，該DHA：ARA之比例係介於約1：2和2：1之間。再於進一步之實施態樣中，該DHA：ARA之比例為約1：1。再於其他實施態樣中，DHA：ARA之比例可為約3：1至約1：9。
於一些實施態樣中，本發明之營養組成物的脂質組分可選擇地包含至少一種下列脂肪酸：C12月桂酸、C14肉荳蔻酸、C16棕櫚酸、C16：1棕櫚油酸、C18
硬脂酸、C18：1油酸、C18：2亞油酸、C18：3 γ-亞麻酸、C20 ARA、C20：3順式-9-11-14-二十碳三烯酸、C20：4 ARA、C22山萮酸、C22：6 DHA或C24掬焦油酸，及彼等之混合物。
用於實施本發明之合適的脂肪或脂質來源可包含本技藝中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、海洋生物油、單細胞油；蔬菜和植物油，諸如玉米油、芥花油、葵花油、大豆油、棕櫚油、椰子油、高油酸葵花油、月見草油、菜籽油、橄欖油、亞麻仁(亞麻籽)油、棉籽油、高油酸紅花油、棕櫚油硬脂、大豆卵磷脂、棕櫚仁油、小麥胚芽油、中鏈三酸甘油酯油。該營養組成物可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個體。
全部或一部分之脂質組分可包含脂質乳劑。於某些實施態樣中，每100毫升之營養組成物中，該脂質組分可構成約2.5克至約5克。於一些實施態樣中，該脂質組分可構成該營養組成物之約5%至約20%。
於一些實施態樣中，該營養組成物進一步包含蛋白質組分。該蛋白質組分可包含，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、酪蛋白酸鹽(例如酪蛋白酸鈉、酪蛋白酸鈉鈣、酪蛋白酸鈣)及彼等之
任何組合。
於一實施態樣中，該蛋白質係以完整蛋白質之形式提供。於其他實施態樣中，該蛋白質係以完整蛋白質與部分水解蛋白之組合物的形式提供，該部分水解蛋白之水解度為約4%至10%。於某些其他實施態樣中，該蛋白質被更完整地水解。再於另一實施態樣中，該蛋白質來源可輔以含有麩胺醯胺之肽類。由於水解蛋白容易消化因而為理想之蛋白質來源。再者，除了已鑑定之胺基酸和蛋白質外，該營養組成物亦可含有額外之氮來源。
於本發明之營養組成物的一些實施態樣中可選擇地包含碳水化合物組分。該營養組成物中所使用之碳水化合物可根據用途而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。由於水解碳水化合物容易消化因而為理想之碳水化合物來源。
該營養組成物可包含礦物質組分。該礦物質組分可選擇地包括，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、銅、硫酸銅(copper sulfate)、葡萄糖酸銅、硫酸銅(cupric sulfate)、氟化物、鐵、羰基鐵、三價鐵、富馬酸亞鐵、正磷酸鐵、鐵研劑(iron trituration)、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(docusate sodium)、氯化鈉、硒酸鈉、鉬酸鈉、鋅、氧化鋅、硫酸鋅及彼等之混合物。礦物質化合物之非限制性示例性衍生物包括任何礦物質化合物之鹽、鹼性鹽、酯及螯合物。
礦物質可以鹽之形式添加在營養組成物中，諸如磷酸鈣、甘油磷酸鈣、檸檬酸鈉、氯化鉀、磷酸鉀、磷酸鎂、硫酸亞鐵、硫酸鋅、硫酸銅(cupric sulfate)、硫酸錳及亞硒酸鈉。額外之維生素及礦物質可藉由本技藝中已知之任何方法添加到營養組成物中。
於該營養組成物的一些實施態樣中可選擇地包含維生素組分。該營養組成物之維生素組分可選擇地包括，但不限於一或多種下列維生素或彼等之衍生物：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(riboflavin)、黃素單核苷酸、FMN、黃素腺嘌呤二核苷酸、FAD、核黃素(lactoflavin)、卵黃素(ovoflavin))、維生素B3(菸鹼酸(niacin)、菸鹼酸(nicotinic acid)、菸醯胺(nicotinamide)、菸鹼醯胺(niacinamide)、菸醯胺腺嘌呤二核苷酸、NAD、菸鹼酸單核苷酸、NicMN、吡啶-3-甲酸)、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、葉酸(folacin)、蝶醯麩胺酸(pteroylglutamic acid))、維生素B12(鈷胺素、甲鈷胺素、脫氧腺苷鈷胺素、氰鈷胺素、羥鈷胺素、腺苷鈷胺素)、生物素、維生
素C(抗壞血酸)、維生素A(視黃醇、醋酸視黃酯、棕櫚酸視黃酯、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、醋酸α-生育酚、琥珀酸α-生育酚、菸鹼酸α-生育酚、γ-生育酚)、維生素K(維生素K1、葉綠醌、萘醌、維生素K2、甲萘醌(menaquinone)-7、維生素K3、甲萘醌-4、甲萘醌(menadione)、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。
於某些實施態樣中，本發明之營養組成物可包含至少一種益生質。於本實施態樣中可添加任何本技藝中已知之益生質。於一特定之實施態樣中，該益生質可選自由下列所組成之群組：果寡醣、葡萄寡醣、半乳寡醣、聚右旋糖、異麥芽寡醣、木寡醣及乳果糖。
於本發明之某些實施態樣中，該營養組成物可含有一或多種益生菌。本實施態樣中可接受本技藝中已知之任何益生菌，惟其達到預期的結果。於一特定之實施態樣中，該益生菌可選自以下群組中之任一者：乳酸桿菌種(Lactobacillus species)、鼠李糖乳桿菌GG(Lactobacillus rhamnosus GG)(美國典型培養物保藏中心編號ATCC 53103)、雙岐桿菌種(Bifidobacterium species)、長雙岐桿菌及動物雙歧桿菌乳亞種BB-12(Bifidobacterium animalis subsp.lactis BB-12)(DSM編
號10140)或彼等之組合。
於一實施態樣中，該益生菌可為可存活的或無法存活的。如本文所使用之術語“可存活的”係指活的微生物。術語“無法存活的”或“無法存活的益生菌”係指無法存活之益生菌微生物、彼等之細胞組分及/或彼等之代謝物。這類無法存活的益生菌可能已經過熱滅殺或以其他方式滅活，但其保留能有利地影響宿主健康的能力。可用於本發明中之益生菌可為天然產生的、合成的或透過有機體之遺傳工程操作研發的，無論這類新來源為現在已知的或稍後研發的。
由於離漿作用，本技藝中已知之許多營養配方傾向物理不穩定及形成不可分散之沉積物。不穩定性係由包含在營養配方中之高含量之蛋白質、脂肪及礦物質所造成，已知營養配方含有彼等以在合理的體積中提供充分的營養。值得注意的是，傳統腸內配方之酸化亦可能導致蛋白質沉澱及相分離。沉澱之營養素通常無法藉由搖動返回溶液中，且其不提供促進個體健康所需之營養益處。
然而，本發明之營養組成物包含進一步含有乳化劑之穩定的乳劑。該乳化劑可包含微膠囊密封劑(microencapsulant)、表面活性劑、乳劑穩定劑或彼等之組合。於一些實施態樣中，該乳化劑可包含，例如卵磷脂、檸檬酸脂肪酸甘油酯(citrem)、單酸甘油酯或二酸甘油酯。於一些實施態樣中，該營養組成物之脂質組分提供為穩定乳劑形式之脂肪酸。於其他實施態樣中，該營養組成
物可包含穩定劑，諸如角叉菜膠來代替乳化劑，或除了乳化劑外，額外包含穩定劑。
於一些實施態樣中，乳化之步驟可經由機械攪拌、超聲波振動、加熱或彼等之組合完成。乳化可使用本技藝中已知之任何用於乳化的方法完成。於一實施態樣中，乳化可包含均質化。於一些實施態樣中，可施加多個均質化步驟，以製造該營養組成物之乳化的脂質組分。
此外，於該營養組成物之一些實施態樣中，蛋白質可作為表面活性劑。蛋白質表面活性劑能夠擴展脂質-水界面以減少微滴凝聚。實際上，蛋白質表面活性劑可降低兩種液體間之界面張力，造成兩種液體溶混。該營養組成物可包含任何水溶性乳化劑。於一些實施態樣中，該營養組成物可包含一種以上之乳化劑及/或穩定劑。
於一實施態樣中，該營養組成物包含具有至少一種LCPUFA之乳劑，該LCPUFA被包含α-乳白蛋白之蛋白質基質穩定化。乳化之LCPUFA可包含DHA。該α-乳白蛋白係作為穩定劑，具體的說，作為表面活性劑。為了製造本發明之營養組成物的穩定乳劑，該脂質組分中可使用額外之表面活性劑、乳劑穩定劑及微膠囊密封劑，但並非必要。於一些實施態樣中，該營養組成物之脂質乳劑中含有直徑在約0.070微米至約1微米之範圍內的油/脂微滴。
此外，該營養組成物之一些實施態樣(諸如那些被優化以用於早產兒或危重嬰兒者)可模擬人類母乳的
某些特性。實際上，該營養配方可包含α-乳白蛋白，此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，該營養組成物可包含較母乳含量高之DHA。該營養組成物之增加的DHA含量補償早產兒之任何DHA不足及/或預防DHA不足出現。
其他營養素和成分，諸如胺基酸、維生素及礦物質可被併入乳劑之液相或水性元素中。將這類其他成分均化後，經由混合而直接加入乳劑中可能是有利的。實際上，穩定之乳劑允許在水性元素中納入其他營養素，而無脂質微滴解吸、破裂或聚結之情況。
再者，於一些實施態樣中，該包含乳劑之營養組成物為營養完整的，含有合適類型及量之脂質、碳水化合物、蛋白質、維生素及礦物質來作為個體之唯一營養來源。實際上，該營養組成物可選擇地包含任意數量之蛋白質、肽、胺基酸、脂肪酸、益生菌及/或彼等之代謝副產物、益生質、碳水化合物及可提供個體許多營養及生理益處之任何其他營養素或其他化合物。
此外，於一些實施態樣中，本發明之營養組成物可包含調味劑、增味劑、甜味劑、色素、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。
本發明之營養組成物可被標準化成特定之卡路里含量，其可以現成產品之形式提供，或其可以濃縮形式提供。
於一些實施態樣中，本發明提供為腸內投予之營養補充劑的營養組成物，其包含含有具至少一種脂肪酸之乳劑的脂質組分。該營養補充劑可以DHA和ARA配製並經過設計以矯正個體(諸如早產兒)之營養不足症。
於一些實施態樣中，該營養組成物為母乳強化劑及/或嬰兒配方強化劑。於這類實施態樣中，該營養組成物包含可很容易地與母乳或嬰兒配方混合之穩定的乳劑形式之DHA和ARA。當嬰兒從腸胃道外營養支持過渡到口服餵食(嬰兒配方或母乳)與部分胃腸道外營養支持之組合時，可將該強化劑形式之營養組成物添加在口服餵食品中以努力確保有適當量之DHA和ARA可用來支持個體之最佳生長及神經發育。
本發明進一步提供用於提供個體(諸如早產兒)營養支持的方法，即接受部分或全靜脈營養療法。該方法包含投予個體本發明之營養組成物。投予之持續時間可有所改變，但該營養組成物應在嬰兒不能充分進食及/或正接受全部或部分全靜脈營養療法時投予。
本發明亦提供用於腸內輸送營養素給那些需要營養素是以非常之小體積投予的個體之方法。
因此，本發明解決可能需要小體積之腸內營養支持之任何族群的需求，這些族群包括，但不限於圍手術期個體、具有短腸症候群之個體、兒科重症照護個體及/或無法充分經口進食或正接受最低限度之腸內營養支持或全靜脈營養療法的任何年齡之任何族群。
於至少一種實施態樣中，本發明針對以小體積輸送一組特定營養素給個體之營養組成物。所產生之營養組成物可為商業上切實可行的且能實際用於重症護理之設置中，包括，但不限於新生兒加護病房(NICU)。於一些實施態樣中，本發明之營養組成物包含腸內營養素輸送系統，藉此將小但精確之量引入個體之消化道中。
於一些實施態樣中，該營養組成物係以至少0.5毫升之體積劑量輸送。於某些實施態樣中，該營養組成物係以約0.7至約1.3毫升之體積劑量輸送。於某些實施態樣中，該營養組成物係以約1毫升之體積輸送。於另一實施態樣中，該營養組成物可以至多約1.5毫升，或至多約2毫升之體積輸送。
於一些實施態樣中，該營養組成物以約1毫升之小體積液體劑量輸送有價值之營養素給早產兒或嬰兒。而早產兒往往過於危重而無法容忍全腸內餵食，本發明之營養組成物係被設計成小體積的營養組成物，其可通過，例如置於在NICU中之嬰兒體內的鼻胃管直接投予嬰兒。因此，本發明之營養組成物可在產後第一天開始投予。
再者，該營養組成物可依醫學專業人員之指示每日投予一次或兩次，或更頻繁。實際上，該營養組成物可依醫學專業人員之指示每日投予三次、每日投予四次，或甚至更頻繁。投予可在出生後立即開始且只要個體有營養需求即持續投予。於一些實施態樣中係每日投予早
產兒該營養組成物，直到等於足月妊娠的時間。於其他實施態樣中投予個體該營養組成物之時間的量等於該患者接受全靜脈營養療法或部分靜脈營養療法的時間。
本發明之營養組成物可經商業包裝，從而使其可直接與腸內營養裝置(包括，但不限於鼻胃管飼、經皮內視鏡胃造口術(gastrostomy)、經皮內視鏡空腸造口術(jejunostomy)、經幽門管飼，等)接口。然而，包裝應與靜脈內饋送線不相容，以將靜脈內投予之風險減至最少。這類設計對確保充分輸送該包裝內容，將污染風險減至最小及增加順應性而言非常方便。此外，於某些實施態樣中，該營養組成物可包裝在總體積約1毫升、總體積約1.5毫升或總體積約2毫升之單一單位劑量輸送包裝中。單位劑量包裝系統為較佳者，以將給藥錯誤減至最少並減少污染的風險。
於一些實施態樣中，該營養組成物可從嬰兒出生開始輸送至符合足月妊娠之時間。於一些實施態樣中，該營養組成物可輸送給嬰兒直到至少約3個月矯正年齡。於另一實施態樣中，該營養組成物可輸送給個體，只要有需要矯正營養不足。再於另一實施態樣中，該營養組成物可從出生開始輸送給嬰兒直到至少約一歲矯正年齡。
所提供之下列實例係用於說明本發明之營養組成物的一些實施態樣，但不應該被解釋為對彼等之任何限制。熟習本技藝之人士從考量本專利說明書或實行本文所揭露之營養組成物或方法可清楚明白在本文之申請專利
範圍內的其他實施態樣。本專利說明書，連同實例被認為僅用於示例，本發明之範圍和精神係由接續在實例後之申請專利範圍所指定。
於一實施態樣中，本發明之營養組成物可被配製成每日投予體重約1公斤之嬰兒兩次。嬰兒可接受兩個1.5毫升份量之營養組成物。該營養組成物可經配製以每天輸送約25.5毫克DHA及每天輸送約17毫克ARA給嬰兒。下文中說明適合用於本實施例之營養組成物的實例：
此外，於另一實施態樣中，該營養組成物可以每份量約1.5毫升之量每天投予嬰兒四次。該營養組成物可被配製成每天輸送約25.5毫克DHA及每天輸送約17毫克ARA給嬰兒。下文中說明適合用於本實施例之營養組成物的實例：
本專利說明書中所引用之所有參考文獻，包括，但不限於所有論文、出版物、專利案、專利申請案、演示、文本、報告、手稿、手冊、書籍、網路貼文、雜誌文章、期刊，等的全部內容在此以引用方式納入本專利說明書中。本文中參考文獻之討論只是為了概述由其作者所下之斷言，並非承認任何參考文獻構成先前技藝。本申請者保留質疑所引用之參考文獻的準確性和相關性之權利。
雖然本發明之實施態樣已使用特定術語、裝置及方法描述，這類描述僅用於說明。所使用之文字係用於描述，而非限制。可理解的是，本技藝之一般技術人士可在不背離本發明之精神和範圍(其陳述於接續之申請專利範圍中)的情況下作出各種改變和變化。此外，應理解的是，各種實施態樣之態樣可以全部或部分互換。例如，
用於生產根據已示例之那些方法製造的無菌液態營養補充劑商品的方法可被考慮用於其他用途。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包含之版本的描述。
Claims (20)
- 一種用於腸內投予早產兒之營養組成物，其包含：脂質組分，其中該脂質組分包含約10%至約20%之花生四烯酸及約15%至約30%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項之營養組成物，其中該脂質組分包含約20%至約30%之二十二碳六烯酸。
- 如申請專利範圍第1項之營養組成物，其中該脂質組分包含約28%之二十二碳六烯酸。
- 如申請專利範圍第1項之營養組成物，其中該脂質組分包含約30%之二十二碳六烯酸。
- 如申請專利範圍第1項之營養組成物，其中該脂質組分包含約15%至約20%之花生四烯酸。
- 如申請專利範圍第1項之營養組成物，其中該脂質組分包含約14%之花生四烯酸。
- 如申請專利範圍第1項之營養組成物，其中該營養補充劑係經配製成輸送至少約50毫克/公斤/天之二十二碳六烯酸。
- 如申請專利範圍第1項之營養組成物，其中該營養補充劑係經配製成輸送至少約60毫克/公斤/天之二十二碳六烯酸。
- 如申請專利範圍第1項之營養組成物，其進一步包含維生素組分。
- 如申請專利範圍第11項之營養組成物，其中該維 生素組分包含維生素A。
- 如申請專利範圍第11項之營養組成物，其中該維生素組分包含維生素D。
- 如申請專利範圍第11項之營養組成物，其中該維生素組分包含維生素K。
- 一種用於提供接受胃腸外營養之早產兒營養支持的方法，該方法包含：腸內投予該嬰兒包含脂質組分之營養組成物，其中該脂質組分包含約10%至約20%之花生四烯酸及約15%至約30%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13項之方法，其中該脂質組分包含約20%至約30%之二十二碳六烯酸。
- 如申請專利範圍第13項之方法，其中該脂質組分包含約28%之二十二碳六烯酸。
- 如申請專利範圍第13項之方法，其中該脂質組分包含約14%之花生四烯酸。
- 如申請專利範圍第13項之方法，其中該營養組成物進一步包含選自由下列所組成之群組的維生素及礦物質組分：維生素A、維生素D及維生素K。
- 如申請專利範圍第13項之方法，其中該營養組成物係以足以投予至少約50毫克/公斤/天之二十二碳六烯酸的量投予嬰兒。
- 如申請專利範圍第18項之方法，其中該營養組成 物係以足以投予至少約60毫克/公斤/天之二十二碳六烯酸的量投予嬰兒。
- 如申請專利範圍第13項之方法，其中該營養組成物係以足以投予至少約40毫克/公斤/天之花生四烯酸的量投予嬰兒。
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| MX358756B (es) | 2012-02-17 | 2018-09-03 | Alcresta Therapeutics Inc | Metodos, composiciones y dispositivos para abastecer las necesidades de acidos grasos dieteticos. |
| NO20150142A1 (en) * | 2015-01-30 | 2016-08-01 | Pronova Biopharma Norge As | Enteral feeding device |
| US10258590B2 (en) | 2015-10-14 | 2019-04-16 | Alcresta Therapeutics, Inc. | Enteral feeding device and related methods of use |
| US11045396B2 (en) * | 2017-08-17 | 2021-06-29 | Alcresta Therapeutics, Inc. | Devices and methods for the supplementation of a nutritional formula |
| EP3755155A1 (en) * | 2018-02-19 | 2020-12-30 | Abbott Laboratories | Lipid emulsion nutritional product |
| CN112314710A (zh) * | 2020-08-21 | 2021-02-05 | 南昌大学 | 一种中国母乳甘油三酯替代脂的制备方法及其应用 |
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| RU2475031C2 (ru) * | 2007-05-18 | 2013-02-20 | Мид Джонсон Нутришен Компани | Подкисленная жидкая добавка к грудному молоку |
| 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 |
| US20110208153A1 (en) * | 2010-02-24 | 2011-08-25 | John Alvey | Formulations and methods for nutrient delivery |
| US9375028B2 (en) * | 2010-12-09 | 2016-06-28 | Mead Johnson Nutrition Company | Compositions and methods for nutrient delivery |
| EP2508180A1 (en) * | 2011-04-04 | 2012-10-10 | Nestec S.A. | Sn-1(3) Monoacylglycerides and lipid absorption |
| CN102696761A (zh) * | 2012-06-19 | 2012-10-03 | 黑龙江飞鹤乳业有限公司 | Dha和ara乳化液的制备方法 |
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| WO2014204621A1 (en) | 2014-12-24 |
| AU2014281110B2 (en) | 2017-10-05 |
| SG10201806517QA (en) | 2018-08-30 |
| BR112015029947A2 (pt) | 2017-07-25 |
| CN105338834A (zh) | 2016-02-17 |
| US20140378419A1 (en) | 2014-12-25 |
| HK1221380A1 (zh) | 2017-06-02 |
| MX2015016587A (es) | 2016-03-16 |
| SG11201509017VA (en) | 2015-11-27 |
| MX370545B (es) | 2019-12-17 |
| EP3019036A1 (en) | 2016-05-18 |
| CA2914196A1 (en) | 2014-12-24 |
| AR096564A1 (es) | 2016-01-13 |
| PH12015502517B1 (en) | 2016-02-29 |
| AU2014281110A1 (en) | 2015-11-12 |
| MY173549A (en) | 2020-02-04 |
| PH12015502517A1 (en) | 2016-02-29 |
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