TW201424592A - 配方奶粉強化劑 - Google Patents
配方奶粉強化劑 Download PDFInfo
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- TW201424592A TW201424592A TW102128308A TW102128308A TW201424592A TW 201424592 A TW201424592 A TW 201424592A TW 102128308 A TW102128308 A TW 102128308A TW 102128308 A TW102128308 A TW 102128308A TW 201424592 A TW201424592 A TW 201424592A
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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
- A23L33/40—Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
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- Life Sciences & Earth Sciences (AREA)
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Mycology (AREA)
- Nutrition Science (AREA)
- Chemical & Material Sciences (AREA)
- Pediatric Medicine (AREA)
- Food Science & Technology (AREA)
- Polymers & Plastics (AREA)
- Coloring Foods And Improving Nutritive Qualities (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Dairy Products (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Abstract
本揭露內容提供包含蛋白質組分、脂肪組分及碳水化合物組分之早產兒配方奶粉強化劑，其中該強化劑之卡路里含量中約10至約30%係來自蛋白質。本揭露內容亦提供用於投予早產兒之組成物，其包含：i)包含蛋白質組分、脂肪組分及碳水化合物組分之早產兒配方奶粉強化劑，其中該強化劑之卡路里含量中約10至約30%係來自蛋白質，及ii)早產兒配方奶粉。此外，本揭露內容提供用於促進早產兒生長之方法，其包含投予嬰兒包含下列者之組成物：i)包含蛋白質組分、脂肪組分及碳水化合物組分之早產兒配方奶粉強化劑，其中該強化劑之卡路里含量中約10至約30%係來自蛋白質，及ii)早產兒配方奶粉。
Description
本揭露內容關於用於補充早產兒配方奶粉之早產兒配方奶粉強化劑。此處所描述之強化劑能增加該配方奶粉之某些營養素的量，且可用於促進早產兒之生長。
未足月兒或早產兒係在妊娠37週前出生和/或出生時體重少於2500克。早產兒包括低出生體重兒(LBW；<2500克)、非常低出生體重兒(VLBW；<1500克)和極低出生體重兒(ELBW；<1000克)。理想上，早產兒之生長速率應符合或超過子宮內生長速率以加速趕上足月兒之生長。由於他們的消化系統發育不全且整體發育不成熟，許多早產兒有特殊之營養需求。歐洲兒科胃腸病學會(ESPGHAN)估計早產兒之蛋白質攝入量應為約3.5至4.5克/千克/天(每100千卡3.2至4.1克)，以達到與子宮內速率相當之體重增加。此外，ESPGHAN建議這類嬰兒之維生素D攝入量為800至1000IU/天。
早產兒經常被餵食市售之早產兒配方奶粉或
擠出之母乳，這通常是經過補充的。然而，市售之早產兒配方奶粉通常每100千卡包含約2.8至約3.5克之蛋白質。此外，母親在分娩早產兒後並非總能分泌母乳，或分泌足夠的量。因此，早產兒配方奶粉可能是必要的。
因此，強化早產兒配方奶粉，以增加配方奶粉中之蛋白質含量，同時保持足夠水準之其他營養素是有需要的。這類組成物可用於補充現有之早產兒配方奶粉。
簡單地說，本揭露內容針對包含蛋白質組分、脂肪組分，及碳水化合物組分之早產兒配方奶粉強化劑，其中該強化劑之卡路里含量中約10至約30%係來自蛋白質。此處所描述之早產兒配方奶粉強化劑可用於，例如在醫院和出院後補充餵養早產兒。更具體地說，此處所描述之強化劑能增加早產兒配方奶粉中的某些營養素之含量以促進早產兒(諸如非常低出生體重兒或極低出生體重兒)之生長。可能藉本強化劑增加之營養素包括，但不限於蛋白質、總卡路里、維生素D及脂肪酸，諸如二十二碳六烯酸。
本揭露內容亦關於用於投予早產兒之組成物，其包含i)包含蛋白質組分、脂肪組分及碳水化合物組分之早產兒配方奶粉強化劑，其中該強化劑之卡路里含量中約10至約30%係來自蛋白質，及ii)早產兒配方奶
粉。
此外，本揭露內容提供用於促進早產兒生長之方法，其包含投予嬰兒包含下列者之組成物：i)包含蛋白質組分、脂肪組分及碳水化合物組分之早產兒配方奶粉強化劑，其中該強化劑之卡路里含量中約10至約30%係來自蛋白質，及ii)早產兒配方奶粉。於某些實施例中，嬰兒之生長速率將符合或超過該嬰兒之預期年齡別生長速率。
現在將參考本揭露內容之實施例做詳細說明，下文中將列舉本揭露內容之實施例的一或多個實例。各實例係用於解釋本揭露內容之早產兒配方奶粉，而非用於限制。事實上，熟習本技藝之人士將清楚明白本揭露內容之教示內容可在不偏離本揭露內容之範圍或精神下做各種修改及變化。例如，所說明或描述之為一種實施例之一部分的特性可與另一實施例一起使用以產生更進一步之實施例。
因此，本揭露內容欲涵蓋在附加之申請專利範圍及其等同物之範圍內的這類修改和變化。本揭露內容之其他目的、特性及觀點揭露於下列詳細說明中或可從其中顯明。本技藝之一般技術人士可理解目前的討論僅用於說明示例性實施例，而不是限制本揭露內容之更廣泛的觀點。
此處所使用之術語“早產兒配方奶粉強化劑”係指用於補充早產兒配方奶粉之組成物。於某些實施例中，該早產兒配方奶粉強化劑可改善與其組合之早產兒配方奶粉之營養含量。例如，於某些實施例中，該強化劑可增加該早產兒配方奶粉之蛋白質含量。該強化劑亦可經配製以增加其它營養素，包括，但不限於總卡路里含量、維生素D或脂肪酸。
“嬰兒”係指年齡不超過約一歲之對象且包括0至12個月之嬰兒。術語嬰兒包括低出生體重嬰兒、極低出生體重之嬰兒和早產兒。“未足月”或“早產”意指在妊娠37週結束前出生或出生時體重低於2500克的嬰兒。“非常低出生體重兒”為出生時體重低於1500克之嬰兒，而“極低出生體重兒”為出生時體重低於1000克之嬰兒。
“無法茁壯成長”(FTT)(此為描述性術語，而非確定之臨床診斷)係用於描述其體重如下之嬰兒和兒童：1)始終低於其年齡別之3%，2)逐步降低至低於3%，3)為其身高和年齡之理想體重的80%，或4)在個人之預定的生長曲線基礎上，體重以意想不到的速度下降，不論是否低於3%。FTT可能由各種潛在原因造成，包括，但不限於因唇裂和/或腭裂、胃食道逆流或倒嚼引起之營養素攝入減少；由於諸如乳糜瀉、囊性纖維化或雙醣酶缺乏之病症造成之吸收不良；果糖不耐受或典型之半乳糖血症的代謝障礙症狀；由諸如糖尿病和蛋白尿之病況造成之排泄增加；及諸如支氣管肺發育不良、囊性纖維化
或甲狀腺功能亢進疾病的能源需求增加。如同早產兒，FTT嬰兒具有額外的營養需求。
“嬰兒配方奶粉”意指滿足至少一部分嬰兒營養需求之組成物。嬰兒配方奶粉亦可能為營養完整的。在美國，嬰兒配方奶粉之含量係由21 C.F.R.章節100、106、及107中所載之聯邦法規規定。這些法規定義大量營養素、維生素、礦物質及其他成分水準以努力模擬人類母乳之營養和其他性能。“早產兒配方奶粉”為經設計以符合早產兒及低出生體重嬰兒之特殊營養需求並促進這類嬰兒之追趕性生長的嬰兒配方奶粉。早產兒配方奶粉包括出院配方奶粉。Enfamil®Premature及Enfamil®Enfacare分別為市售早產兒配方奶粉及出院配方奶粉之實例。一般而言，與嬰兒配方奶粉相比較，早產兒配方奶粉具有增加之卡路里和蛋白質含量，亦可能包括增加之其他營養素水準。
“營養完整”意指可用作唯一之營養來源的組成物，該組成物可實質上補充所有每日需要量之與蛋白質、碳水化合物和脂質組合的維生素、礦物質和/或微量元素。確實，“營養完整”係描述能提供支持對象正常生長和發育所需之足量碳水化合物、脂質、必須脂肪酸、蛋白質、必須胺基酸、半必須胺基酸、維生素、礦物質和能源的營養組成物。對早產兒而言為“營養完整”的嬰兒配方奶粉將提供早產兒生長所需之定性和定量上足量的碳水化合物、脂質、必須脂肪酸、蛋白質、必須胺基酸、半必須胺基酸、維生素、礦物質及能源。
當應用於營養素時，術語“必須”係指身體無法合成足夠量以供正常生長及維持健康，因此必須由膳食供應的任何營養素。術語“半必須”當應用於營養素時意指當身體無法取得足夠量之先質化合物以進行內源性合成，或身體無法合成足夠量時，必須由膳食供應之營養素。
“益菌素”意指不易消化之食物成分，其能經由選擇性地刺激消化道中一或有限數量之腸道益菌生長和/或活性、選擇性地減少腸道病原體、或有利地影響可改善宿主健康之腸道短鏈脂肪酸組合形廓來有益地影響宿主。
除非另有規定，此處所使用之所有百分比、份數和比例係按總調和物之重量計。
本揭露內容提供早產兒配方奶粉強化劑，於某些實施例中，該早產兒配方奶粉強化劑可用於餵養早產兒，包括VLBW嬰兒或ELBW嬰兒，以及FTT嬰兒。更特別地，此處所描述之強化劑加上早產兒配方奶粉可用於餵養這類嬰兒。
此處所揭露之早產兒配方奶粉強化劑包含蛋白質組分、脂肪組分及碳水化合物組分，其中該強化劑之卡路里含量中約10至約30%係來自蛋白質。於某些實施例中，該強化劑之卡路里含量中約12至約25%係來自蛋白質，而於其它實施例中，該強化劑之卡路里含量中約14至約22%係來自蛋白質。
更特別地，於某些實施例中，該強化劑包含每7.5千卡之強化劑中約0.19至約0.56克之蛋白質。於
替換之實施例中，該強化劑包含每7.5千卡之強化劑中約0.23至約0.47克之蛋白質，或每7.5千卡之強化劑中約0.27至約0.41克之蛋白質。
合適之蛋白質來源包括適合嬰兒食用之任何蛋白質或氮源。例如，該蛋白質來源可為本技藝中所使用之任何蛋白質來源，例如脫脂乳、乳清蛋白、酪蛋白、大豆蛋白、水解蛋白、游離胺基酸，等。用於實行本揭露內容之牛乳蛋白來源包括，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、脫脂牛奶、脫脂乳、脫脂乾乳、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、酸性酪蛋白、酪蛋白酸鹽(例如酪蛋白酸鈉、酪蛋白酸鈣鈉、酪蛋白酸鈣)及彼等之任何組合。
於某些實施例中，該蛋白質來源包含完整的、經水解的或經部分水解的蛋白質，諸如水解之乳清蛋白分離物。若該蛋白質為經水解的，其可能為經部分水解的或經廣泛水解的。該蛋白質來源亦可能包含胺基酸。於一些實施例中，該蛋白質來源可能為完整蛋白質與經水解之蛋白質的組合物。當該強化劑包含經水解或經部分水解的蛋白質時，該強化劑適合與包含完整的或經水解之蛋白質的早產兒配方奶粉一起使用。
於一些實施例中，該早產兒配方奶粉強化劑之卡路里含量中約20至約50%係來自脂肪，而於其它實施例中，該早產兒配方奶粉強化劑之卡路里含量中約25
至約45%係來自脂肪。再於另一實施例中，該早產兒配方奶粉強化劑之卡路里含量中約30至約40%係來自脂肪。
可用於此處所描述之早產兒配方奶粉強化劑之合適的脂肪來源包括，但不限於動物來源，例如乳脂、奶油、奶油脂肪、蛋黃脂質、牛脂(液牛油)；海洋來源，諸如魚油、海洋油、單細胞油；蔬菜和植物油，諸如玉米油、菜籽油、紅花油、葵花油、大豆油、棕櫚油、棕櫚油精(palm olein oil)、椰子油、巴巴蘇仁油(babassu oil)、星實櫚油(tucum oil)、可可脂、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、棕櫚仁油、小麥胚芽油；中鏈三酸甘油酯(例如MCT油)和其他構造性脂質，諸如Betapol®或InFatTM，及乳劑和脂肪酸之酯類；以及彼等之任何組合。於某些實施例中，該脂肪來源包含中鏈三酸甘油酯油。
於某些實施例中，該強化劑之卡路里含量中約30至約60%係來自碳水化合物，而於其它實施例中，該強化劑之卡路里含量中約35至約55%係來自碳水化合物。再於另一實施例中，該強化劑之卡路里含量中約42至約54%係來自碳水化合物。
用於早產兒配方奶粉強化劑中之碳水化合物來源可為本技藝中已知之任何碳水化合物來源。於一些實施例中，該碳水化合物來源包含玉米糖漿固體、麥芽糖糊精、乳糖、或彼等之組合。於其它實施例中，該碳水化合
物來源包含玉米糖漿固體。其他碳水化合物來源包括澱粉，諸如玉米、樹薯粉、稻米、或馬鈴薯、玉米澱粉、葡萄糖聚合物、蔗糖、玉米糖漿、葡萄糖、稻米糖漿、果糖、高果糖玉米糖漿、不消化之寡醣及彼等之組合。該碳水化合物可為經水解的(部分地或廣泛地)或完整的且可為非經改質的或經化學改質的。
於某些實施例中，該早產兒配方奶粉強化劑進一步包含維生素D。例如，該強化劑包含每7.5千卡之強化劑中約50至約200國際單位(IU)之維生素D。於其他實施例中，該強化劑包含每7.5千卡之強化劑中約100至約150IU，或約110至約137IU之維生素D。於這些實施例中，該強化劑能夠增加早產兒配方奶粉之維生素D含量。
該早產兒配方奶粉強化劑可進一步包括長鏈多不飽和脂肪酸(LCPUFA)之來源。合適之LCPUFAs包括，但不限於二十二碳六烯酸、α-亞油酸、γ-亞油酸、亞油酸、亞麻仁油酸、二十碳五烯酸(EPA)和花生四烯酸(ARA)。於某些實施例中，該強化劑包含DHA、ARA或兩者。當該強化劑包含ARA和DHA二者時，ARA：DHA之重量比可在約1：3和約9：1之間。於特殊實施例中，該ARA：DHA之比率為約1：2至約4：1。
當包含DHA時，該DHA之量可在每7.5千卡之強化劑約0.5至約10毫克的範圍內。於另一實施例
中，該DHA之量可在每7.5千卡之強化劑約1至約5毫克的範圍內。當ARA存在時，該ARA之量可在每7.5千卡之強化劑約1至約10毫克的範圍內，而於另一實施例中，該ARA之量可在每7.5千卡之強化劑約2至約5毫克的範圍內。
該DHA和/或ARA之來源可為本技藝中已知之任何DHA和/或ARA之來源，諸如海洋油、魚油、單細胞油、蛋黃脂質及腦脂質。於一些實施例中，該DHA和ARA係源自單細胞Martek油，諸如DHASCO®及ARASCO®、或彼等之變化。該DHA和ARA可為天然形式，其先決條件為該LCPUFA來源的其餘部分不會對該對象造成任何實質的有害影響。或者，可使用DHA和ARA之精製形式。
於一實施例中，該DHA和ARA之來源為如美國專利案第5,374,657；5,550,156；和5,397,591號(其揭露內容全文以引用方式納入此處)中所教示之單細胞油。然而，本揭露內容並不限於這類油。
於一實施例中，該早產兒配方奶粉強化劑為酸性。例如，該強化劑之pH值可在約4.0至約4.6之範圍內。於一些實施例中，該強化劑之pH值可在約4.1和4.5之間。大多數微生物在高於4.6之pH環境中顯現出最佳的生長。雖不欲受限於任何特定的理論，咸信，藉由提供其pH值低於約4.6之早產兒配方奶粉強化劑可減少或防止許多人類健康病原體(諸如肉毒梭菌(C.botulinum)和
阪崎腸桿菌(E.sakazakii))的生長，並可減少或防止許多食品腐敗微生物。降低之pH值亦可防止嗜溫和嗜熱性孢子的生長。因此，上述之pH值範圍降低該強化劑在運輸和儲存過程中將發生微生物生長的可能性。
於某些實施例中，該強化劑包含果膠。於某些實施例中，該果膠之量可在每10,000升強化劑中約40至約60公斤果膠之範圍內，而於其它實施例中，該果膠之量在每10,000升中約50至約56公斤果膠之範圍內。雖然不欲受限於任何特定理論，咸信，添加果膠可提供黏性較不含果膠之強化劑為低的早產兒配方奶粉強化劑。果膠亦可經由減少發泡、乳油化或脂肪分離，和/或礦物質和/或蛋白質沉澱來協助強化劑包裝。這產生具有較佳外觀之產品。例如，該產品可能顯示出較少凝結且亦更容易將其中所含之營養素投遞給嬰兒，因為該營養素在產品中之懸浮情況較佳。該營養素不太可能沈澱和/或黏附在管子或瓶子上。該強化劑可選擇性地包括一或多種其它抗起泡劑，諸如消泡1520US。
此處所描述之早產兒配方奶粉強化劑能增加早產兒配方奶粉之某些營養素的濃度。因此，早產兒配方奶粉強化劑可有利地與早產兒配方奶粉結合以提供用於投予早產兒(包括非常低出生體重(VLBW)和極低出生體重(ELBW)嬰兒，以及FTT嬰兒)之組成物。例如，於某些實施例中，當本早產兒配方奶粉強化劑被添加在早產兒配方奶粉中時，所產生之組成物之蛋白質含量增加。市
售之早產兒和出院配方奶粉(諸如Enfamil®Premature和Enfamil®EnfaCare)一般包含每100千卡約2.8至約3.5克蛋白質。於一實施例中，此處所描述之與早產兒配方奶粉結合的強化劑提供包含每100千卡約3至約5.5克之蛋白質的組成物。於其它實施例中，所產生之組成物包含每100千卡約3.2至約4.5克之蛋白質，再於其他實施例中，該組成物包含每100千卡約3.5至約4.0克之蛋白質。
於一些實施例中，可使用本強化劑增加早產兒配方奶粉之總卡路里含量。例如，市售之早產兒配方奶粉通常包括每盎司約20至約24千卡。然而，增加之卡路里攝入量對促進早產兒之追趕生長可能是有利的。因此，於一些實施例中，當加入此處所描述之強化劑時，所產生之組成物的卡路里增加至每盎司約22至約30千卡。於一些實施例中，本組成物包含每盎司約23至約27千卡。
於一些實施例中，該早產兒配方奶粉強化劑包含每5毫升強化劑約5千卡至約10千卡。於其他實施例中，該強化劑包含每5毫升強化劑至少7.5千卡。
於其中該強化劑包含維生素D之實施例可增加中該早產兒配方奶粉之維生素D含量。例如，於一些實施例中，該強化劑與早產兒配方奶粉之組合可產生包含每100千卡約300至約1000IU之維生素D的組成物，而於其它實施例中，該組成物包含每100千卡約500至約800IU之維生素D。再於其它實施例中，該組成物包含每100
千卡約570至約670IU之維生素D。
於某些實施例中，該強化劑與早產兒配方奶粉係以強化劑：配方奶粉之比例為約1：1至約1：10組合，而於其他實施例中，該強化劑：配方奶粉之比例為約1：2至約1：8，或1：4至約1：6。熟習本技藝之人士可根據該嬰兒之特殊需要來改變添加在早產兒配方奶粉中之強化劑的量。因此，約10至約50毫升之早產兒配方奶粉中可以添加約5毫升之強化劑。或者，約20至約30毫升之早產兒配方奶粉中可以添加約5毫升之強化劑。
於其它實施例中，該強化劑可與早產兒配方奶粉膳食分開，但組合投予嬰兒。因此，約5毫升之強化劑可與早產兒配方奶粉分開餵食。於本實施例中，該強化劑對配方奶粉之比例可為約1：1至1：10、約1：2至1：8、或1：4至1：6。
本揭露內容亦提供用於促進早產兒生長的方法，其包含投予如此處所描述之強化劑及早產兒配方奶粉。例如，該方法可包含投予包含如此處所描述之早產兒配方奶粉強化劑及早產兒配方奶粉之組成物。於某些實施例中，該早產兒之生長速率符合或超過預期之年齡別生長速率，從而促進追趕生長。於某些實施例中，該早產兒為VLBW或ELBW嬰兒。於其他實施例中，該嬰兒為FTT嬰兒。
本揭露內容之早產兒配方奶粉強化劑可以本技藝已知之任何形式提供，諸如粉末、凝膠、懸浮液、糊
劑、固體、液體、液體濃縮、可重構成之奶粉替代物或即時可用之產品。於某些實施例中，該強化劑係以無菌液體提供且方便地以個別份量包裝。本技藝中可取得且已知多種類型之包裝和容器。例如，該強化劑可能包裝在從紙、鋁箔、塑料、或經鋁箔和塑料塗層之紙製造之包裝或藥囊中，及從塑料、紙或玻璃製造之安瓿中。於特定之實施例中，該強化劑係被填入成型-充填-密封包裝或吹瓶-充填-密封包裝中並在防止該產品被微生物再污染的環境中密封。於本實施例中係在經過設計和操作以將微生物污染的可能性減至最小的封閉區域中，在無人工干預之連續過程中形成容器、充填強化劑，並密封。這類包裝可為強化劑之單位劑量。因此，該經設計以直接添加至早產兒配方奶粉中之包裝可包含約5毫升之強化劑。
於某些實施例中，為了避免稀釋營養素，該強化劑包含傳統上可在早產兒配方奶粉中找到之額外營養素，包括維生素、礦物質、核苷酸及脂肪酸。若需要時，該額外之營養素的量可適合維持早產兒配方奶粉中之濃度，或增加所選擇之營養素濃度。可用於本發明中之維生素包括，例如維生素A、維生素D、維生素E、維生素K1、硫胺素、核黃素(riboflavin)、維生素B6、維生素B12、菸鹼酸、葉酸、泛酸、生物素及維生素C。可添加之礦物質營養素包括、例如鈣、磷、鎂、鋅、錳、銅、鈉、鉀、氯化物、鐵、硒、鉻和鉬。更具體地說，該強化劑可選擇性地包括一或多種以下維生素或其衍生物：維生
素B1(硫胺素、焦磷酸硫胺素、三磷酸硫胺素、鹽酸硫胺素、一硝酸硫胺素)、維生素B2(核黃素、黃素單核苷酸、黃素腺嘌呤二核苷酸、乳核黃素、卵核黃素)、維生素B3(菸鹼酸、菸酸、菸鹼醯胺(nicotinamide)、菸醯胺(niacinamide)、菸鹼醯胺腺嘌呤二核苷酸、菸酸單核苷酸、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、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、α-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。可添加之額外的維生素和礦物質係在本技藝之一般技術人士之知識範圍內，本技藝之一般技術人士可依循美國兒科學會或其他專家團體(如ESPGHAN)之建議來決定適當量之維生素和礦物質營養
素。
於某些實施例中，該早產兒配方奶粉強化劑亦可能含有一或多種益菌素。這類益菌素可為天然產生的、合成的或透過有機體和/或植物之遺傳工程操作研發，無論這類新來源為現在已知的或稍後研發的。可用於本揭露內容中之益菌素可包括寡醣、多醣及其他含有果糖、木糖、大豆、半乳糖、葡萄糖和甘露糖之益菌素。
更具體地說，可用於本揭露內容中之益菌素可包括聚右旋糖、聚右旋糖粉、乳果糖、乳果寡醣、棉籽糖、葡萄寡醣、菊糖、果寡醣(亦稱為寡果糖)、異麥芽寡醣、大豆寡醣、乳果糖、木寡醣、殼寡醣(chito-oligosaccharide)、甘露寡醣、阿拉伯寡醣、唾液酸寡醣、岩藻寡醣(fuco-oligosaccharide)、半乳寡醣及龍膽寡醣(gentio-oligosaccharides)。
於一實施例中，存在於該強化劑中之益菌素的總量可為約1.0克/升至約10.0克/升組成物。該益菌素中至少20%可包含半乳寡醣、聚右旋糖或彼等之混合物。於一實施例中，在該強化劑中之各半乳寡醣和/或聚右旋糖的量可在約1.0克/升至約4.0克/升的範圍內。
於一實施例中，本揭露內容之強化劑包含膽鹼。膽鹼為正常細胞之功能所必要之營養素。其為膜磷脂之先質，且其加速乙醯膽鹼(此為涉及記憶儲存之神經遞質)的合成和釋出。此外，儘管不欲受此理論或任何其他理論約束，咸信，膳食膽鹼和DHA協同作用以促進生物
合成磷脂醯膽鹼，從而協助促進人類對象中之突觸生成。此外，膽鹼和DHA可能顯現出促進樹突棘形成之協同效果，這在維持已建立之突觸連接上是很重要的。於一些實施例中，本揭露內容之營養組成物包含每8盎司用量約40毫克至約100毫克膽鹼。
於一實施例中，此處所描述之強化劑包含鐵之來源。於一實施例中，該鐵之來源為焦磷酸鐵、正磷酸鐵、富馬酸亞鐵或彼等之混合物，且於一些實施例中，可將該鐵之來源包封。
本揭露內容之早產兒配方奶粉強化劑可選擇性地包括一或多種可添加以穩定該最終產品之乳化劑。合適之乳化劑實例包括，但不限於卵磷脂(例如來自卵或大豆)、α-乳白蛋白和/或單-及二甘油酯，及彼等之混合物。熟習本技藝之人士可輕易明瞭其他乳化劑，而合適之乳化劑之選擇將部分取決於該調合物和最終產品。
本揭露內容之強化劑可選擇性地包括一或多種亦可添加以延長產品之貨架期的防腐劑。合適之防腐劑包括，但不限於山梨酸鉀、山梨酸鈉、苯甲酸鉀、苯甲酸鈉、乙二胺四醋酸二鈉鈣，及彼等之混合物。
本揭露內容之強化劑可選擇性地包括一或多種穩定劑。用於實行本揭露內容之營養組成物的合適穩定劑包括，但不限於阿拉伯膠、印度樹膠(gum ghatti)、刺梧桐樹膠(gum karaya)、黃蓍膠、瓊脂、紅藻膠(furcellaran)、果阿膠(guar gum)、結冷膠(gellan
gum)、刺槐豆膠、果膠、低甲氧基果膠、明膠、微晶型纖維素、羧甲基纖維素鈉、甲基纖維素、羥丙基甲基纖維素、羥丙基纖維素、單-和二甘油酯之二乙醯基酒石酸酯、右旋糖苷(dextran)、角叉菜膠及彼等之混合物。
除非另有規定或明確暗示與所引用之背景相反，本揭露內容中之單數特性或限制的所有引用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引用之組合的背景相反，此處所使用之方法或過程步驟的所有組合可以任何順序執行。
本揭露內容之方法和組成物(包括其組分)可包含下列者、由下列者所組成或實質上由下列者所組成：此處所描述之實施例的必要元素和限制，以及任何額外或可選擇之成分、此處所描述或其他可用於營養組成物中之組分或限制。
此處所使用之術語“約”應解釋為係指該具體指定之兩個數字範圍中之任何範圍。對範圍之任何引用應被認為對該範圍內之任何子集提供支持。
提供之實例係用於說明本揭露內容之營養組成物的一些實施例，但不應被解釋為用來對其做任何限制。熟習本技藝之人士從考量本專利說明書或實行此處所揭露之營養組成物或方法可清楚明白立此處之申請專利範圍內的其他實施例。本專利說明書，連同實例僅用於示例，本揭露內容之範圍和精神係由接續在實例後之申請專
利範圍所指定。
表1中描述具有及不具有本揭露內容之強化劑的早產兒配方奶粉(Enfamil® Premature)中之大量營養素的卡路里分佈之實例。添加在Enfamil® Premature高蛋白質中之強化劑的量足以將蛋白質從3.5克/100千卡增加至4.0克/100千卡。
表2描述根據本揭露內容之強化劑，以及具有早產兒配方奶粉及該強化劑之組成物的營養素組合形廓(Enfamil® Premature高蛋白質)。
此實例列出示例性早產兒配方奶粉強化劑中之成分。
實施例3之調合物可進一步包括額外之維生素、礦物質及核苷酸，例如那些通常用於嬰兒配方奶粉中者。
本專利說明書中所引用之所有參考資料，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被納入本專利說明書中。比處之參考資料的討論只是為了概述由其作者所下之斷言，並非承認任何引用構成先前技藝。本申請者保留質疑所引用之參考資料的準確性和相關性之權利。
雖然本揭露內容之實施例已使用特定術語、裝置和方法描述，這類描述僅用於說明。所使用之文字是描述，而非限制之文字。須理解的是，本技藝之一般技術人士可在不背離本揭露內容之精神和範圍(這些列於接續之申請專利範圍內)的情況下作出各種改變和變化。此外，應理解的是，各種實施例之觀點可以全部或部分互換。例如，雖然已示例用於製造根據那些方法製作之市售無菌液體營養補充物的方法，仍可以考慮其他用途。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說明。
Claims (20)
- 一種早產兒配方奶粉強化劑，其包含：蛋白質組分，脂肪組分，及碳水化合物組分，其中該強化劑之卡路里含量中約10至約30%係來自蛋白質。
- 如申請專利範圍第1項之早產兒配方奶粉強化劑，其中該強化劑之卡路里含量中約12至約25%係來自蛋白質。
- 如申請專利範圍第1項之早產兒配方奶粉強化劑，其中該蛋白質組分包含水解之蛋白質或部分水解之蛋白質。
- 如申請專利範圍第1項之早產兒配方奶粉強化劑，其中該蛋白質組分包含水解之乳清蛋白分離物。
- 如申請專利範圍第1項之早產兒配方奶粉強化劑，其中該強化劑之卡路里含量中約25至約50%係來自脂肪。
- 如申請專利範圍第1項之早產兒配方奶粉強化劑，其中該脂肪組分包含中鏈三酸甘油酯。
- 如申請專利範圍第1項之早產兒配方奶粉強化劑，其中該強化劑之卡路里含量中約30至約60%係來自碳水化合物。
- 如申請專利範圍第1項之早產兒配方奶粉強化 劑，其進一步包含對每7.5千卡之強化劑而言為約50至約200個國際單位(IU)之維生素D。
- 如申請專利範圍第1項之早產兒配方奶粉強化劑，其進一步包含長鏈多不飽和脂肪酸(LCPUFA)之來源。
- 如申請專利範圍第1項之早產兒配方奶粉強化劑，其中該強化劑之pH值為4.6或更小。
- 如申請專利範圍第1項之早產兒配方奶粉強化劑，其進一步包含果膠。
- 如申請專利範圍第1項之早產兒配方奶粉強化劑，其進一步包含維生素及礦物質。
- 如申請專利範圍第1項之早產兒配方奶粉強化劑，其中該早產兒強化劑係用於非常低出生體重(VLBW)嬰兒或極低出生體重(ELBW)嬰兒。
- 一種用於投予早產兒之組成物，其包含：i)早產兒配方奶粉強化劑，其包含：蛋白質組分，脂肪組分，及碳水化合物組分，其中該強化劑之卡路里含量中約10至約30%係來自蛋白質；及ii)早產兒配方奶粉。
- 如申請專利範圍第14項之組成物，其中該組成物包含對每100千卡該組成物而言為約3至約5.5克之蛋 白質。
- 如申請專利範圍第14項之組成物，其中每盎司該組成物包含約22至約30千卡。
- 如申請專利範圍第14項之組成物，其中該組成物包含約300至1000IU之維生素D。
- 如申請專利範圍第14項之組成物，其中該早產兒配方奶粉強化劑對早產兒配方奶粉之體積比係在約1：2至約1：10之範圍內。
- 如申請專利範圍第14項之組成物，其中該早產兒配方奶粉強化劑對早產兒配方奶粉之體積比係在約1：4至約1：5之範圍內。
- 一種用於促進早產兒生長的方法，其包含投予該嬰兒包含下列者之組成物：i)早產兒配方奶粉強化劑，其包含：蛋白質組分，脂肪組分，及碳水化合物組分，其中該強化劑之卡路里含量中約10至約30%係來自蛋白質；及ii)早產兒配方奶粉。
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| US12239142B2 (en) * | 2023-02-15 | 2025-03-04 | The Trustees Of Princeton University | Methods, devices and compositions for preserving human milk |
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| WO2014035582A1 (en) | 2014-03-06 |
| MY173927A (en) | 2020-02-27 |
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| CA2880861C (en) | 2020-07-07 |
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| CA2880861A1 (en) | 2014-03-06 |
| HK1209287A1 (zh) | 2016-04-01 |
| SG11201408840YA (en) | 2015-01-29 |
| AU2013309437B2 (en) | 2016-09-01 |
| CO7310519A2 (es) | 2015-06-30 |
| MX2015000690A (es) | 2015-04-08 |
| US20140057014A1 (en) | 2014-02-27 |
| CN108902943A (zh) | 2018-11-30 |
| IN2015DN00102A (zh) | 2015-05-29 |
| CN104540398A (zh) | 2015-04-22 |
| BR112015002606A2 (pt) | 2017-07-04 |
| PH12015500683A1 (en) | 2015-05-18 |
| RU2015109670A (ru) | 2016-10-20 |
| EP2887824A1 (en) | 2015-07-01 |
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