TWI527581B - 包含hmb的無菌包裝營養液 - Google Patents
包含hmb的無菌包裝營養液 Download PDFInfo
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- TWI527581B TWI527581B TW100103536A TW100103536A TWI527581B TW I527581 B TWI527581 B TW I527581B TW 100103536 A TW100103536 A TW 100103536A TW 100103536 A TW100103536 A TW 100103536A TW I527581 B TWI527581 B TW I527581B
- Authority
- TW
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- Prior art keywords
- nutrient solution
- protein
- soluble
- peroxide
- hmb
- Prior art date
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- 239000007788 liquid Substances 0.000 title claims description 19
- 235000016709 nutrition Nutrition 0.000 title description 60
- AXFYFNCPONWUHW-UHFFFAOYSA-N 3-hydroxyisovaleric acid Chemical compound CC(C)(O)CC(O)=O AXFYFNCPONWUHW-UHFFFAOYSA-N 0.000 claims description 172
- 235000015097 nutrients Nutrition 0.000 claims description 125
- 235000018102 proteins Nutrition 0.000 claims description 80
- 102000004169 proteins and genes Human genes 0.000 claims description 80
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- 229910052791 calcium Inorganic materials 0.000 claims description 63
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims description 53
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- BECPQYXYKAMYBN-UHFFFAOYSA-N casein, tech. Chemical compound NCCCCC(C(O)=O)N=C(O)C(CC(O)=O)N=C(O)C(CCC(O)=N)N=C(O)C(CC(C)C)N=C(O)C(CCC(O)=O)N=C(O)C(CC(O)=O)N=C(O)C(CCC(O)=O)N=C(O)C(C(C)O)N=C(O)C(CCC(O)=N)N=C(O)C(CCC(O)=N)N=C(O)C(CCC(O)=N)N=C(O)C(CCC(O)=O)N=C(O)C(CCC(O)=O)N=C(O)C(COP(O)(O)=O)N=C(O)C(CCC(O)=N)N=C(O)C(N)CC1=CC=CC=C1 BECPQYXYKAMYBN-UHFFFAOYSA-N 0.000 claims description 14
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- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims description 12
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 claims description 12
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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Description
本發明係關於包含β-羥基-β-甲基丁酸(HMB)之無菌包裝營養液。
存在許多不同類型之適於經口投與人類的包裝營養液,該等組合物通常包含多量營養素與微量營養素之各種組合。許多此等包裝液體經調配為基於乳或蛋白質之乳劑以用作唯一或補充營養來源。此等包裝乳劑常常以包含脂肪、蛋白質、碳水化合物、維生素及礦物質之水包油乳劑形式製造,其中一些實例包括購自Abbott Laboratories(Columbus,Ohio USA)之ENSURE營養液及GLUCERNA混合飲料。
在製造製程期間,此等包裝營養組合物經滅菌以使微生物污染物減少至使得組合物適於經口投與人類所必需之程度。此等製程常常包括熱製程,諸如蒸餾滅菌及無菌製程滅菌。典型蒸餾製程涉及將營養組合物引入適合之容器中,密封該容器,隨後在對於滅菌足夠之溫度下加熱密封容器及其內含物一段時間。另一方面,無菌下滅菌製程通常涉及分別滅菌食品級容器之內部及營養組合物,隨後在潔淨室環境下組合經滅菌之容器與經滅菌之營養組合物並密封容器。
多年來,用於對營養組合物滅菌之無菌下滅菌製程已大受歡迎。藉由使用該等製程,營養產品不必加熱至高達蒸餾滅菌所需之溫度。此等較低溫度一般為較佳,因為其與較高溫度相比使得產品氧化量減少。另外,相較於塑膠容器之蒸餾滅菌,塑膠容器之無菌下滅菌一般為較佳,因為蒸餾滅菌需要高溫加熱塑膠容器,此會導致塑膠容器在滅菌期間遭破壞。
儘管無菌下滅菌已大受歡迎且相較於蒸餾滅菌具有數個優點,但無菌下滅菌要求在引入經滅菌之營養組合物之前對容器內部滅菌。此內部滅菌常常藉由將通常呈霧化形式之含有過氧化物之溶液(諸如過氧化氫溶液)引入容器內部且乾燥該溶液以產生經滅菌之表面來進行。與所用之乾燥製程無關,過氧化物殘餘物保留在容器之內表面上。此殘餘物會在一些應用中成為問題,因為其隨時間會遷移至營養組合物中且使得隨後引入使用過氧化物處理之容器中的營養組合物之pH值降低。
營養液之pH值由於氧化而隨時間降低會對包裝內之營養液具有許多有害作用,包括:(1)增加所結合礦物質之釋放,該等呈離子形式之礦物質會由於沈澱而損害營養液之穩定性;(2)增加催化氧化之量,尤其鐵及銅物質之催化氧化之量;(3)增加蛋白質沈澱之量;及(4)增加維生素C不穩定。任一此等不當作用可明顯降低營養液之商業可接受性。
因此,需要穩定營養組合物,諸如,諸如基於蛋白質或乳之穩定液體或乳劑,其可引入使用過氧化物處理之無菌下滅菌容器中且穩定並對pH值隨時間降低具有抵抗力。
本發明係關於一種包含使用過氧化物處理之無菌包裝及含於或密封於其中之營養液的組合物,該營養液包含β-羥基-β-甲基丁酸以及脂肪、碳水化合物及蛋白質中之至少一者。如本文所提及之使用過氧化物處理之包裝可為已經受基於過氧化物之無菌處理的包裝,或僅為另外在與營養液組合之前、期間及/或之後含有過氧化物殘餘物之包裝,而不考慮將該等過氧化物物質引入包裝之製程或情況。
過氧化物殘餘物在用於代表包裝組分之特徵時可在至多達出售營養產品之國家或地區中適用於該產品的可接受之量或含量的範圍內。以組合或含有於包裝中之營養液的重量計,該等過氧化物含量最通常小於0.5 ppm,包括約0.001 ppm至約0.5 ppm,且亦包括約0.05 ppm至約0.1 ppm。
本發明進一步係關於一種製備在使用過氧化物處理之無菌包裝中之pH值穩定營養液之方法。該方法包含將脂肪、蛋白質、碳水化合物及β-羥基-β-甲基丁酸組合在一起形成營養液,對該營養液滅菌,藉由用含有過氧化物之溶液處理至少包裝內部,來對該包裝無菌下滅菌,及將經滅菌之營養液引入經無菌下滅菌之包裝中。
已發現將β-羥基-β-甲基丁酸(HMB)添加至營養液(諸如營養乳劑)中可賦予營養液緩衝作用,以使得營養液對氫離子濃度改變後之pH值變化較具抵抗力。此出人意料之作用為有利的,因為HMB為營養組合物之所需添加劑且基於目前之發現,目前可將其添加至營養液中以使得營養液可包裝於已使用含有過氧化物之溶液無菌下滅菌,以使得所得營養液之pH值由於溶液中存在之HMB的緩衝作用而更穩定的容器中。因為引入使用含有過氧化物之溶液無菌下滅菌的容器中之營養液在性質上較易發生如上文所論述之pH值隨時間改變,所以有關HMB在營養液中之緩衝作用之出人意料的發現尤其適用於引入已使用含有過氧化物之溶液無菌下滅菌的容器中之營養液。
本發明之包裝營養組合物可包含HMB以及脂肪、蛋白質及碳水化合物中之至少一者,且亦可包括一或多種視情況選用或其他組分、特徵或成分。下文詳細描述營養液之基本特徵以及許多視情況存在之變化中的一些。
除非另外規定,否則如本文中所使用,術語「HMB」係指β-羥基-β-甲基丁酸(亦稱為β-羥基-3-甲基丁酸、β-羥基異戊酸)或其來源(諸如HMB之鈣鹽)。除非另外規定,否則當HMB之來源為鈣HMB時,此特定來源最通常為單水合物,因此如本文中所使用且關於鈣HMB之所有重量、百分比及濃度均以鈣HMB單水合物之重量計。
除非另外規定,否則如本文中所使用,術語「營養液」意謂包含脂肪、蛋白質及碳水化合物中之至少一者的調配物,其適於經口投與人類且在所欲投藥溫度(其最通常為約1℃至約25℃)下具有可飲用黏度。在此情形下,在目標溫度下之可飲用黏度通常將小於約300 cps,更通常約10 cps至約160 cps,且甚至更通常約20 cps至約70 cps。除非另外規定,否則如本文中所使用之黏度值係在目標溫度下使用布絡克菲爾德黏度計(Brookfield Viscometer)(型號DV-II+)以62號轉軸獲得。該黏度係藉由在作為有可能獲得處於刻度範圍內之讀數之最高速度的轉軸速度下操作黏度計來量測。所量測之黏度值表示剪切應力與剪切速率之比率,以達因(dynes)-秒/平方公分或泊(poise)表示,或更通常以厘泊(cps)或百分之一泊表示。
除非另外規定,否則如本文中所使用,術語「存放穩定」係指營養液在包裝隨後在18-25℃下儲存至少約3個月(包括約6個月至約24個月且亦包括約12個月至約18個月)後可保持商品穩定。
除非另外規定,否則如本文中所使用,術語「營養乳劑」意謂調配為水性乳劑之營養液,包括油包水、水包油及複合乳劑,但最通常為水包油乳劑。
除非另外規定,否則如本文中所使用,術語「脂肪」及「油」可互換使用,係指自植物或動物得到或加工之脂質物質。此等術語亦包括合成脂質物質,只要該等合成物質適於經口投與人類即可。
除非另外規定,否則如本文中所使用,術語「pH值穩定」意謂基於β-羥基-β-甲基丁酸之緩衝作用,使其pH值可以抗拒或至少較能抗拒pH值下降。
除非另外規定,否則如本文中所使用,術語「塑膠」意謂經美國食品與藥品管理局(U.S. Food and Drug Administration)或其他適合之監管部門批准之食品級塑膠,其中一些非限制性實例包括聚氯乙烯、聚對苯二甲酸伸乙酯、高密度聚乙烯、聚丙烯、聚碳酸酯等。
除非另外規定,否則如本文中所使用,術語「滅菌」係指使食品中或食品級表面上之諸如真菌、細菌、病毒、孢子形式等傳播媒介物減少至使得該等食品適於人類食用所必需之程度。滅菌製程可包括涉及應用熱、過氧化物或其他化學物質、照射、高壓、過濾或其組合或變化形式之各種技術。
除非另外規定,否則如本文中所使用,所有百分比、分率及比率均以總組合物之重量計。除非另外規定,否則與所列成分有關之所有該等重量均以活性含量計且因此不包括市售物質中可能包括之溶劑或副產物。
除非另外規定或所提及之上下文明確暗示與此相反,否則所有對本發明之單數特徵或限制的提及應包括相應複數特徵或限制,反之亦然。
除非另外規定或提及組合之上下文明確暗示與此相反,否則如本文中所使用,方法或製程步驟之所有組合均可以任何順序進行。
本發明之營養乳劑的各種實施例亦可實質上不含本文所述之任何視情況選用或所選之基本成分或特徵,其限制條件為其餘營養乳劑仍含有如本文所述之所有必需成分或特徵。在此情形下且除非另外規定,否則術語「實質上不含」意謂所選營養乳劑含有小於功能量之視情況選用的成分,通常小於約0.5重量%,包括小於約0.1重量%,且亦包括0重量%該視情況選用或所選之基本成分。
本發明之營養液及相應製造方法可包含如本文所述之本發明的基本要素及特徵、由其組成或基本上由其組成,以及本文所述或另外適用於營養應用之任何其他或視情況選用的成分、特徵或要素。
本發明之營養液包含脂肪、蛋白質及碳水化合物中之至少一者,其適於經口投與人類且在所欲投藥溫度下具有可飲用黏度。此等組合物最通常調配為乳劑,諸如水包油、油包水或複合水性乳劑,且甚至更通常調配為具有連續水相及不連續油相之水包油乳劑。營養液可穩定存放。
營養液之特徵亦在於其為即食或即飲液體,此意謂該等液體以液體形式包裝,且適於在自盛裝液體之封閉塑膠容器中移出後,立即按原樣食用。換言之,本發明並不涵蓋經調配或另外復原且需要在調配或復原後24-72小時內使用之營養粉或其他組合物。
儘管營養液最通常呈存放穩定之乳劑形式,但此等液體亦可調配為非乳劑,諸如溶液、懸浮液(懸浮固體)、凝膠等。此等營養液亦可調配為需要冷藏來維持長存放期之非存放穩定產品。
以營養液之重量計,營養液通常含有至多約95重量%水,包括約50重量%至約95重量%,亦包括約60重量%至約90重量%,且亦包括約70重量%至約85重量%水。
營養液可用足夠種類及量之營養素調配,以提供唯一、主要或補充營養來源,或提供用於罹患特定疾病或病狀之個體的特殊營養液。此等營養組合物可具有各種產品密度,但最通常密度大於約1.055 g/ml,包括1.06 g/ml至1.12 g/ml,且亦包括約1.085 g/ml至約1.10 g/ml。
營養液可具有適合最終使用者之營養需求的熱量密度,但在大多數情況下,組合物包含每240 ml約100 kcal至約500 kcal,包括每240 ml約150 kcal至約350 kcal,且亦包括每240 ml約200 kcal至約320 kcal。此等營養組合物亦包含如本文所述之HMB,其量最通常在每240 ml約0.5 g至約3.0 g之範圍內,包括每240 ml約0.75 g至約2.0 g,包括每240 ml約1.5 g。
營養液之pH值可在約3.5至約8之範圍內,但最適宜在約4.5至約7.5之範圍內,包括約5.5至約7.3,包括約6.2至約7.2。
儘管營養乳劑之份量大小可視許多變數而變化,但典型份量大小在約100 ml至約300 ml之範圍內,包括約150 ml至約250 ml,包括約190 ml至約240 ml。
營養液包含適用於口服營養產品中之HMB或其任何來源且另外與營養液之基本要素或特徵相容。
營養液最適合包含HMB之鈣鹽,其鈣鹽最通常呈單水合物形式。儘管鈣HMB或鈣HMB單水合物為用於本文中之較佳HMB來源,但其他適合之來源可包括呈游離酸、其他鹽形式(包括無水鹽)、酯、內酯或另外自營養液提供生物可利用形式之HMB的其他產品形式之HMB。適用於本文中之HMB之鹽的非限制性實例包括鈉、鉀、鎂、鉻、鈣之HMB鹽(水合或無水),或其他無毒性鹽形式。鈣HMB單水合物為較佳且可購自Technical Sourcing International(TSI)(Salt Lake City,Utah)。
以營養液之重量計,營養液中鈣HMB之濃度(包括鈣HMB或鈣HMB單水合物之濃度(當其在本文中用作HMB來源時))可在至多約10%之範圍內,包括約0.1%至約8%,且亦包括約0.2%至約5.0%,且亦包括約0.3%至約3%,且亦包括約0.4%至約1.5%,且亦包括約0.45%。
除HMB外,營養液亦包含脂肪、蛋白質及碳水化合物中之至少一者。一般而言,已知或另外適用於營養產品之任何脂肪、蛋白質及碳水化合物來源亦可適用於本文中,其限制條件為該等多量營養素亦與如本文所定義之營養液的基本要素相容。
儘管脂肪、蛋白質及碳水化合物之總濃度或量可視所欲使用者之營養需求而變化,但該等濃度或量最通常處於以下具體範圍之一,包括如本文所述之其他脂肪、蛋白質及/或碳水化合物成分。
以營養液之重量計,碳水化合物濃度最通常在約5%至約40%之範圍內,包括約7%至約30%,包括約10%至約25%;以營養液之重量計,脂肪濃度最通常在約1%至約30%之範圍內,包括約2%至約15%,且亦包括約4%至約10%;且以營養液之重量計,蛋白質濃度最通常在約0.5%至約30%之範圍內,包括約1%至約15%,且亦包括約2%至約10%。
營養液中碳水化合物、脂肪及/或蛋白質之含量或量亦可另外或改用如下表中所示佔營養組合物之總卡路里的百分比為特徵。
適用於本文所述之營養液中之脂肪或其來源的非限制性實例包括椰子油、分餾椰子油、大豆油、玉米油、橄欖油、紅花油、高油酸紅花油、MCT油(中鏈甘油三酯)、葵花籽油、高油酸葵花籽油、棕櫚油及棕櫚仁油、棕櫚油精、菜籽油、海洋生物油、棉籽油及其組合。
適用於本文所述之營養液中之碳水化合物或其來源的非限制性實例可包括麥芽糊精、水解或改質澱粉或玉米澱粉、葡萄糖聚合物、玉米糖漿、玉米糖漿固體、來源於稻米之碳水化合物、葡萄糖、果糖、乳糖、高果糖玉米糖漿、蜂蜜、糖醇(例如麥芽糖醇、赤藻糖醇、山梨糖醇)及其組合。
適用於營養液中之蛋白質或其來源的非限制性實例包括水解、部分水解或非水解蛋白質或蛋白質來源,其可來源於任何已知或另外適合之來源,諸如乳(例如酪蛋白、乳清)、動物(例如肉類、魚類)、穀類(例如稻米、玉米)、植物(例如大豆)或其組合。該等蛋白質之非限制性實例包括分離乳蛋白、如本文所述之乳蛋白濃縮物、分離酪蛋白、乳清蛋白、酪蛋白鈉及酪蛋白鈣、全牛乳、部分或完全脫脂乳、分離大豆蛋白、大豆蛋白濃縮物等。
當用如本文所述之脂肪組分調配時,營養液尤其適用,因為該等成分在水性乳劑中可能易於隨時間氧化,由此產生隨時間漸增的氫離子濃度,在不使用本文之HMB或其他緩衝系統的情況下,此可導致組合物pH值降低,從而導致產品穩定性降低。
本發明之營養液可包含所選量之可溶性蛋白質以改良產品穩定性且使苦味及餘味隨時間之產生減至最少。
以營養液中總蛋白質之重量計,可溶性蛋白質可佔約35%至100%,包括約40%至約85%,包括約60%至約80%,且亦包括約65%至約75%。以營養液之重量計,可溶性蛋白質之濃度可在至少約0.5%之範圍內,包括約1%至約26%,且亦包括約2%至約15%,亦包括約3%至約10%,且亦包括約4%至約8%。
營養液中所包括之可溶性蛋白質含量之特徵亦在於其為可溶性蛋白質與HMB之重量比,其中營養液中可溶性蛋白質與HMB(包括鈣HMB及/或鈣HMB單水合物)之重量比為至少約3.0,包括約4.0至約12.0,亦包括約7.0至約11.0,且亦包括約8.0至約10.0。
除非另外規定,否則如本文中所使用,術語「可溶性蛋白質」係指如根據包括以下步驟之蛋白質溶解性量測測試所量測,溶解性為至少約90%之彼等蛋白質:(1)將蛋白質以2.00%(w/w)懸浮於水中;(2)在20℃下劇烈攪拌1小時,形成懸浮液;(3)移出懸浮液之等分試樣,且測定蛋白質濃度作為總蛋白質;(4)在31,000×g下及20℃下離心懸浮液1小時;(5)測定上清液中之蛋白質濃度(可溶性蛋白質);及(6)以佔總蛋白質之百分比表示可溶性蛋白質。
任何可溶性蛋白質來源均適用於本文中,其限制條件為其符合如本文所定義之溶解性要求,其中一些非限制性實例包括酪蛋白鈉(如藉由蛋白質溶解性量測測試所測定,溶解性>95%)、乳清蛋白濃縮物(如藉由蛋白質溶解性量測測試所測定,溶解性>90%)及其組合。當然,不溶性蛋白質亦可包括在營養乳劑中。
適用於本文中之可溶性蛋白質亦可以蛋白質中磷酸絲胺酸之含量為特徵,其中在此情形下,可溶性蛋白質定義為每公斤蛋白質具有至少約100毫莫耳,包括約150至400毫莫耳,包括約200至約350毫莫耳,且亦包括約250至約350毫莫耳磷酸絲胺酸的彼等蛋白質。
當可溶性蛋白質按照磷酸絲胺酸含量定義時,已發現可溶性蛋白質(具有確定磷酸絲胺酸含量)與鈣HMB之重量比可為至少約3:1,包括至少約5:1,且亦包括至少約7:1,且亦包括約9:1至約30:1。在此情形下,具有必需含量之磷酸絲胺酸的蛋白質最通常呈單價酪蛋白鹽之形式,諸如酪蛋白鈉、酪蛋白鉀及其組合。
在一實施例中,可溶性蛋白質亦可以單價酪蛋白鹽磷酸絲胺酸與鈣HMB單水合物之莫耳比為特徵,該莫耳比最小為約0.2,包括約0.2至約2.0,且亦包括約0.25至1.7。
然而,應瞭解任何含有磷酸絲胺酸之蛋白質可適用於本文中,其限制條件為其具有必需磷酸絲胺酸含量且用於計算比率之磷酸絲胺酸不結合、複合或另外連接於多價陽離子(諸如鈣或鎂)。
亦應注意如本文所述之用於可溶性蛋白質的替代定義可包括具有極少或無磷酸絲胺酸含量之蛋白質,因此組合物之可溶性蛋白質部分可包括有及/或無磷酸絲胺酸之可溶性蛋白質。用於本文中之可溶性蛋白質因此可由任一或多種可溶性蛋白質特徵分別或組合定義。
蛋白質中之磷酸絲胺酸部分因此可用於與自鈣HMB釋放之鈣結合,因此上述可溶性蛋白質與鈣HMB之比率為蛋白質與在調配期間未結合、未連接或另外可用於結合來自鈣HMB之可溶性鈣的磷酸絲胺酸部分之比率。例如,組合物中使用酪蛋白鈣與酪蛋白鈉之混合物,但由磷酸絲胺酸含量定義之蛋白質與鈣HMB之比率基於來自酪蛋白鈉之蛋白質部分及另外來自未結合於鈣之酪蛋白鈣部分的任何蛋白質計算。
本發明之營養組合物可包括在乳劑中包含所選重量比之可溶性鈣結合能力(SCBC)與總可溶性鈣以改良產品穩定性且使苦味及餘味隨時間之產生減至最少的乳劑實施例。
乳劑實施例之可溶性鈣結合能力(如本文所定義)與總可溶性鈣之比率為至少約2.3之重量比,包括約2.3至約12.0,亦包括約3.0至約8.0,且亦包括約4.0至約6.5,其中該比率係根據以下公式測定:
比率=SCBC/[可溶性鈣]
SCBC=(0.32×[可溶性檸檬酸鹽]+0.63[可溶性磷酸鹽]+0.013×[可溶性蛋白質])
SCBC與總可溶性鈣濃度之重量比可經調整以使營養乳劑中未結合鈣之濃度減至最小,或使乳劑中該未結合鈣與HMB之重量比減至最小,從而改良產品穩定性且減少苦味及餘味隨時間之產生。
本發明之營養液可進一步包含鈣,作為用於發展或維持目標個體之健康肌肉的所需物質。當使用鈣HMB或鈣HMB單水合物作為HMB來源時可提供一些或所有鈣。然而,可使用任何其他鈣來源,其限制條件為該其他來源與營養液之基本要素相容。
營養液中鈣之濃度可超過約10 mg/L,且亦可包括約25 mg/L至約3000 mg/L之濃度,亦包括約50 mg/L至約500 mg/L,且亦包括約100 mg/L至約300 mg/L。
為使本文乳劑實施例之味道及穩定性問題減至最少,鈣可經調配,以使鈣在乳劑中之溶解程度減至最小。因此,乳劑實施例中溶解鈣濃度可小於約900 mg/L,包括小於約700 mg/L,亦包括約500 mg/L至約700 mg/L,且亦包括約400 mg/L至約600 mg/L。在此情形下,術語「溶解鈣」係指如在20℃下所量測之營養液中之上清液鈣。
營養液中之鈣亦可以溶解檸檬酸鹽與溶解鈣的比率(以當量計)為特徵,該比率不超過5.0,包括不超過4.0,亦包括不超過3.0,且亦包括約0.8至約3.0。在此情形下,術語「溶解檸檬酸鹽」及「溶解鈣」分別係指如在20℃下所量測之於營養液之上清液中存在的檸檬酘鹽及鈣陽離子之當量。
營養液之鈣組分亦可以溶解鈣含量為特徵,其小於900 mg/L,包括小於700 mg/L,且亦包括小於600 mg/L,且亦包括400 mg/L至700 mg/L營養乳劑,其中鈣HMB或其單水合物形式與溶解鈣的重量比在約6至約15之範圍內,包括約6至約12,亦包括約6至約10,且亦包括約6至約8。
本發明之營養組合物可進一步包含維生素D,以幫助維持目標使用者之健康肌肉。維生素D形式包括維生素D2(麥角鈣化醇)及維生素D3(膽鈣化醇)或適用於營養產品中之其他形式。
營養液中維生素D之量最通常在每份至多約1000 IU之範圍內,更通常為約10至約600 IU,且更通常為約50至400 IU。
營養液可進一步包含其他視情況選用之成分,其可改良產品之物理、化學、喜好或加工特徵或當用於目標群體時充當藥物或其他營養組分。許多該等視情況選用之成分為已知的或另外適用於其他營養產品中且亦可用於本文所述之營養液中,其限制條件為該等視情況選用之成分對於經口投藥為安全且有效的並與所選產品形式中之基本及其他成分相容。
該等視情況選用之成分的非限制性實例包括防腐劑、抗氧化劑、乳化劑、其他緩衝劑、醫藥活性劑、如本文所述之其他營養素、著色劑、調味劑、增稠劑及穩定劑等。
營養液可進一步包含維生素或相關營養素,其非限制性實例包括維生素A、維生素B、維生素K、噻胺、核黃素、吡哆醇、維生素B12、類胡蘿蔔素、菸酸、葉酸、泛酸、生物素、維生素C、膽鹼、肌醇、鹽及其衍生物及其組合。
營養液可進一步包含礦物質,其非限制性實例包括磷、鎂、鐵、鋅、錳、銅、鈉、鉀、鉬、鉻、硒、氯化物及其組合。
營養液亦可包括一或多種掩蔽劑以減少或另外掩蓋乳劑中殘餘苦味及餘味隨時間之產生。適合之掩蔽劑包括天然及人造甜味劑、鈉源(諸如氯化鈉)及水膠體(諸如瓜爾膠(guar gum)、三仙膠(xanthan gum)、角叉菜膠、結冷膠(gellan gum)及其組合)。營養液中掩蔽劑之量可視所選特定掩蔽劑、調配物中之其他成分及其他調配物或產品目標變數而變化。然而,以營養液之重量計,該等量最通常在至少約0.1%之範圍內,包括約0.15%至約3.0%,且亦包括約0.18%至約2.5%。
本文所述之營養液適用於提供補充、主要或唯一營養來源,及/或為個體提供一或多種如本文所述之益處。根據該等方法,液體可按需要經口投與以提供所需含量之營養,最通常為每日一至兩份之形式,每日一或兩個或兩個以上分次劑量,例如份量大小通常在約100 ml至約300 ml之範圍內,包括約150 ml至約250 ml,包括約190 ml至約240 ml,其中各份含有約0.4 g至約3.0 g,包括約0.75 g至約2.0 g,包括約1.5 g鈣HMB/份。
該等方法進一步係關於在投與該等產品後,最通常在約1至約6個月(包括約1至約3個月)之長時間內每日使用後為個體提供以下一或多者:1)幫助維持瘦體質;2)保持強度及/或肌肉強度;3)減少肌肉細胞之蛋白質分解及損傷;4)幫助運動或其他創傷後肌肉康復;及5)減少運動後肌肉蛋白分解。
該等方法亦有助於達成以下一或多者:1)維持及保持患有骨骼肌減少症之老年人之瘦體質;2)提供營養以保持個體(尤其老年人)之積極且獨立的生活方式;3)幫助肌肉強度恢復;4)幫助重建肌肉及恢復強度;及5)改善強度(包括肌肉強度)及活動性。
營養液可藉由任何已知或另外適合於製備營養乳劑或其他液體,最通常適合於製備營養水性乳劑或基於乳之乳劑之方法製造。
在一種適合之製造製程中,例如製備至少三種各別漿料,包括脂肪包蛋白質(protein-in-fat,PIF)漿料、碳水化合物-礦物質(CHO-MIN)漿料及水包蛋白質(protein-in-water,PIW)漿料。藉由加熱及混合所選油類(例如菜籽油、玉米油等),隨後在持續加熱及攪拌下添加乳化劑(例如卵磷脂)、脂溶性維生素及一部分總蛋白質(例如乳蛋白濃縮物等)來形成PIF漿料。藉由在加熱攪拌下將以下添加至水中來形成CHO-MIN漿料:礦物質(例如檸檬酸鉀、磷酸氫二鉀、檸檬酸鈉等)、痕量及超痕量礦物質(TM/UTM預混物)、增稠劑或懸浮劑(例如晶性維生素(Avicel)、結冷膠、角叉菜膠)及鈣HMB或其他HMB來源。所得CHO-MIN漿料在持續加熱及攪拌下保持10分鐘,隨後添加其他礦物質(例如氯化鉀、碳酸鎂、碘化鉀等)、碳水化合物(例如果寡醣、蔗糖、玉米糖漿等)。接著藉由在加熱及攪拌下將其餘蛋白質(例如酪蛋白鈉、大豆蛋白質濃縮物等)混合於水中來形成PIW漿料。
接著將所得漿料在加熱攪拌下摻合在一起且將pH值調整至所需範圍(通常為6.6-7.0),隨後對組合物進行高溫短時(HTST)加工,在此期間將組合物熱處理、乳化及均質化,隨後使其冷卻。添加水溶性維生素及抗壞血酸,必要時將pH值調整至所需範圍,添加調味劑,且添加水以達成所需總固體含量。接著無菌包裝組合物以形成無菌包裝營養乳劑或營養液。
在無菌下滅菌方法中,例如將營養液或營養乳劑滅菌且將容器分開滅菌。營養液可使用例如加熱製程來滅菌。該容器可藉由用過氧化氫噴灑至少容器之內壁,隨後乾燥該內壁來滅菌。在容器及營養液或營養乳劑皆已滅菌後,在潔淨室環境下將液體或乳劑引入容器中且密封容器。以組合物之重量計,組合物中之殘餘過氧化物含量小於0.5 ppm。
因為無菌下滅菌一般可能需要使用過氧化氫作為容器內部之滅菌劑,所以包裝於經無菌下滅菌之容器中的經無菌處理之營養液或營養乳劑易隨時間發生pH值變化,因為一般在經無菌處理之容器的內壁上存在殘餘過氧化氫,其可進入液體及乳劑並引起pH值變化。因此,尤其有益的是將HMB引入如本文所述之營養液或營養乳劑中以幫助緩衝液體或乳劑且防止產品之pH值隨時間不當變化。
在不脫離本發明精神及範疇的情況下,可使用其他製造製程、技術及所述製程之變化形式來製備營養液或營養乳劑。
本發明之營養液係包裝於容器中,該容器以重量計全部或大部分可為塑膠、金屬、玻璃、紙、紙板,即包含該等材料之組合的包裝,諸如具有塑膠主體及金屬蓋、蓋子、邊緣或其他次要包裝組分之罐子。
容器可為單劑量容器,或可為多劑量可再密封或可再密閉容器,其可能具有或可能不具有密封件(諸如位於蓋下方之薄箔密封件)。該容器較佳能夠經受住如本文所述之無菌滅菌製程且為一般技術者所已知。
塑膠容器,在一些實施例中可為擠壓成形塑膠容器,可包含單層塑膠,或可包含兩層或兩層以上(多層)塑膠且可能具有或可能不具有中間層。一種適合之塑膠材料為高密度聚乙烯。適合之中間層為乙烯乙烯醇。在一特定實施例中,塑膠容器為具有箔密封件及可再密閉蓋之8盎司(ounce)多層塑膠瓶,其中該多層瓶包含兩個高密度聚乙烯層及一個乙烯乙烯醇中間層。在另一實施例中,塑膠容器為具有箔密封件及可再密閉蓋之32盎司單層或多層塑膠瓶。
用於本文所述之營養組合物的塑膠容器或包裝一般經訂定尺寸及組態以最大限度地限制存在於其中之頂空量。因為位於頂空之空氣中的氧氣可引起營養組合物之各種組分的不當氧化,所以一般較佳限制頂空,且因此限制存在於塑膠包裝中之氧氣量。在一實施例中,塑膠包裝或容器包括小於約13立方公分之頂空。在另一實施例中,塑膠包裝包括小於約10立方公分之頂空。
金屬、玻璃、紙板及紙容器亦為此項技術中所熟知且可由一般技術者基於本文中之揭示內容適當地選擇。此等類型之容器一般適用於無菌滅菌方法且因此適用於本發明。
以下實例說明本發明之營養液的特定實施例及/或特徵。該等實例僅出於說明之目的提供且不應理解為限制本發明,因為可在不脫離本發明之精神及範疇的情況下對其作出許多變化。除非另外規定,否則所有例示性量均為以組合物之總重量計的重量百分比。
此說明HMB在復原PediaSure粉末(營養乳劑)中之緩衝作用。在室溫下將已知量之稀鹽酸添加至復原PediaSure粉末對照樣品(Abbott Laboratories,Columbus Ohio)(無HMB)及復原PediaSure粉末樣品(其中該粉末以每公斤復原粉末5.17公克HMB強化)中。經由自鈣HMB單水合物中以陽離子交換方式移除鈣來製備用於強化含有HMB之樣品的HMB。在將游離HMB添加至樣品中之前,用氫氧化鈉將其pH值調整至6.7。將等莫耳量之鈉以氯化鈉形式添加至對照樣品中。在持續攪拌下,在添加鹽酸後一分鐘量測各樣品之pH值。由pH值讀數計算氫離子濃度(H+)。結果示於下表中:
上表中之數據顯示與營養液中存在HMB相關之可量測緩衝作用。包括HMB之樣品之pH值的總體降低小於不包括HMB之樣品之pH值的降低。又,與不包括HMB之樣品相比,包括HMB之樣品的[H+]增加較少。因此,HMB在營養液中提供緩衝作用。
此說明HMB在復原PediaSure粉末(營養乳劑)中之緩衝作用。將已知量之過氧化氫(每公斤復原粉末1.32 mg)添加至復原PediaSure粉末對照樣品(無HMB)及復原PediaSure粉末樣品(其中該粉末以每公斤復原粉末5.17公克HMB強化)中。經由自鈣HMB單水合物中以陽離子交換方式移除鈣來製備用於強化包括HMB之樣品的HMB。在將游離HMB添加至樣品中之前,用氫氧化鈉將其pH值調整至6.7。將等莫耳量之鈉以氯化鈉形式添加至對照樣品中。在持續攪拌下,在室溫下1小時後量測各樣品之pH值且由該等pH值計算[H+]濃度。結果示於下表中:
上表中之數據顯示與營養乳劑中存在HMB相關之可量測緩衝作用。包括HMB之樣品之pH值的總體降低小於不包括HMB之樣品之pH值的降低。又,與不包括HMB之樣品相比,包括HMB之樣品的[H+]增加較少。因此,HMB在營養液中提供緩衝作用。
此說明HMB在作為營養乳劑之即飲液體中之緩衝作用。經由鹽酸滴定及氫氧化鈉滴定來比較市售Ensure Plus(1號樣品)(Abbott Laboratories,Columbus,Ohio)及2號樣品(基於Ensure Plus且每公斤乳劑包括6.5公克鈣HMB及2.38公克磷酸鹽之液體營養乳劑)之緩衝能力。結果示於下表中:
如上表中所示,與1號樣品相比,包括鈣HMB之2號樣品對pH值降低明顯更具抵抗力。此數據顯示HMB賦予營養液抗拒pH值降低(經由添加酸而降低)之能力高於抗拒pH值升高(經由添加NaOH而升高)之能力,而具有選擇性緩衝作用。此特徵尤其適用於隨時間易於發生pH值降低及由其引起之產品不穩定性的營養乳劑及其他營養液。
實例1、2及3之pH值數據顯示當HMB存在於營養液中時,其提供緩衝作用以使得該營養液對添加酸後之pH值降低更具抵抗力。當調配包裝於塑膠容器中之營養液時,此發現尤其適用。因為塑膠容器及尤其使用過氧化氫溶液無菌處理之塑膠容器之pH值易於隨時間降低,所以將HMB添加至營養液中不僅提供營養益處,而且提供緩衝作用從而保護營養液免受與營養液pH值降低相關之有害作用。
以下實例說明本發明之一些存放穩定營養液,其可根據本文所述之製造方法來製備。此等組合物包括水性水包油乳劑及其他營養液,其包裝於塑膠及其他容器中且在調配/包裝後在1-25℃範圍內之儲存溫度下保持物理上穩定12-18個月。
調配物為包裝於塑膠及其他容器中且經無菌下滅菌製程滅菌之存放穩定營養液。組合物隨時間產生極小或不產生苦味或餘味且在1-25℃範圍內之儲存溫度下在12-18個月之存放期內保持pH值穩定及物理上穩定。包裝組分組合物之殘餘過氧化物含量小於0.5 ppm。
例示性組合物可藉由任何已知或另外適合於製備營養液之方法來製備,包括本文所述將所選成分組合成各別碳水化合物-礦物質漿料(CHO-MIN)、各別水包蛋白質漿料(PIW)及各別脂肪包蛋白質漿料(PIF)之方法。對於各個漿料而言,在適合於所選物質之溫度及剪切力下將成分混合在一起,隨後將不同漿料於摻合槽中組合,進行超高溫處理(UHT),隨後在約3000 psi下均質化。接著將維生素、調味劑及其他對熱敏感性物質添加至經均質化之混合物中。按需要用水稀釋所得混合物以達成所需濃度及密度(一般為約1.085 g/mL至約1.10 g/mL)。接著對所得營養液進行無菌下滅菌且使用240 ml可再封閉塑膠瓶包裝。包裝乳劑之pH值為3.5-7.5。
實例4-7說明本發明之營養乳劑,其成分列於下表中。除非另外規定,否則所有成分量均以每批1000公斤產品的公斤數列出。
此等實例說明本發明之營養乳劑,其成分列於下表中。除非另外規定,否則所有成分量均以每批1000公斤產品的公斤數列出。
此等實例說明本發明之營養乳劑,其成分列於下表中。除非另外規定,否則所有成分量均以每批1000公斤產品的公斤數列出。
此等實例說明本發明之營養乳劑,其成分列於下表中。除非另外規定,否則所有成分量均以每批1000公斤產品的公斤數列出。
此等實例說明本發明之營養乳劑,其成分列於下表中。除非另外規定,否則所有成分量均以每批1000公斤產品的公斤數列出。
此等實例說明本發明之透明非乳劑液體,其成分列於下表中。除非另外規定,否則所有成分量均以每批1000公斤產品的公斤數列出。該等液體經調整之pH值介於4.5與7.2之間。
Claims (12)
- 一種包裝組合物,其包含使用過氧化物處理之無菌包裝及密封於其中之pH值穩定營養液,該營養液包含β-羥基-β-甲基丁酸、可溶性鈣、可溶性檸檬酸鹽、可溶性磷酸鹽、包含可溶性蛋白質之蛋白質、碳水化合物及脂肪,其中(i)該營養液中可溶性鈣結合能力(SCBC)與總可溶性鈣之重量比為2.3:1至12:1,(ii)該SCBC=0.32×[可溶性檸檬酸鹽]+0.63[可溶性磷酸鹽]+0.013×[可溶性蛋白質]),及(iii)該營養液包含以該營養液之重量計0.48%至10.0%β-羥基-β-甲基丁酸。
- 如請求項1之包裝組合物,其中該使用過氧化物處理之無菌包裝以重量計大部分為塑膠。
- 如請求項1之包裝組合物,其中該使用過氧化物處理之無菌包裝以重量計大部分為金屬。
- 如請求項1之包裝組合物,其中該營養液包含脂肪、碳水化合物、蛋白質及β-羥基-β-甲基丁酸,其中該蛋白質包含50重量%至100重量%該可溶性蛋白質且包括含有磷酸絲胺酸之蛋白質,每公斤含有磷酸絲胺酸之蛋白質具有至少100毫莫耳磷酸絲胺酸。
- 如請求項1之包裝組合物,其中該可溶性蛋白質係選自酪蛋白鈉、乳清蛋白濃縮物或其組合。
- 如請求項1之包裝組合物,其中該使用過氧化物處理之 無菌包裝含有小於13立方公分之頂空。
- 一種製備在使用過氧化物處理之無菌包裝中之pH值穩定營養液之方法,該方法包含:i)將包含可溶性蛋白質之蛋白質、碳水化合物、脂肪、β-羥基-β-甲基丁酸、可溶性鈣、可溶性檸檬酸鹽及可溶性磷酸鹽組合在一起形成營養液,其中(a)該營養液中可溶性鈣結合能力(SCBC)與總可溶性鈣之重量比為2.3:1至12:1,(b)該SCBC=0.32×[可溶性檸檬酸鹽]+0.63[可溶性磷酸鹽]+0.013×[可溶性蛋白質]),且(c)該營養液包含以該營養液之重量計0.48%至10.0% β-羥基-β-甲基丁酸;ii)對該營養液滅菌;iii)藉由用含有過氧化物之溶液處理包裝內部,來對該包裝無菌下滅菌;及iv)將該經滅菌之營養液引入該經無菌下滅菌之包裝中。
- 如請求項7之方法,其中該使用過氧化物處理之無菌包裝包含選自由玻璃、塑膠、金屬、紙、紙板及其組合組成之群的材料。
- 如請求項7之方法,其中該使用過氧化物處理之無菌包裝可再封閉。
- 如請求項7之方法,其中該可溶性蛋白質係選自由酪蛋白鈉、乳清蛋白濃縮物及其組合組成之群。
- 如請求項7之方法,其中該營養液中該可溶性鈣結合能力與該總可溶性鈣之重量比為5:1至12:1。
- 如請求項7之方法,其中該含有過氧化物之溶液為過氧化氫。
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-
2011
- 2011-01-28 US US13/016,248 patent/US8916217B2/en active Active
- 2011-01-28 PE PE2012001078A patent/PE20121730A1/es not_active Application Discontinuation
- 2011-01-28 RU RU2012125878/13A patent/RU2012125878A/ru not_active Application Discontinuation
- 2011-01-28 TW TW100103536A patent/TWI527581B/zh active
- 2011-01-28 ES ES11705723.2T patent/ES2436890T3/es active Active
- 2011-01-28 MX MX2012008784A patent/MX2012008784A/es active IP Right Grant
- 2011-01-28 BR BR112012018174A patent/BR112012018174A2/pt not_active IP Right Cessation
- 2011-01-28 SG SG2012056578A patent/SG182808A1/en unknown
- 2011-01-28 CN CN201180007420.7A patent/CN102711522B/zh active Active
- 2011-01-28 CA CA2785523A patent/CA2785523A1/en not_active Abandoned
- 2011-01-28 WO PCT/US2011/022932 patent/WO2011094548A1/en active Application Filing
- 2011-01-28 JP JP2012551324A patent/JP6076741B2/ja active Active
- 2011-01-28 EP EP11705723.2A patent/EP2461704B1/en active Active
- 2011-01-28 AU AU2011210682A patent/AU2011210682A1/en not_active Abandoned
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- 2012-07-19 CO CO12122154A patent/CO6561820A2/es not_active Application Discontinuation
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BR112012018174A2 (pt) | 2019-08-27 |
CO6561820A2 (es) | 2012-11-15 |
MX2012008784A (es) | 2012-08-17 |
CA2785523A1 (en) | 2011-08-04 |
US8916217B2 (en) | 2014-12-23 |
PE20121730A1 (es) | 2013-01-13 |
EP2461704A1 (en) | 2012-06-13 |
JP6076741B2 (ja) | 2017-02-08 |
TW201200130A (en) | 2012-01-01 |
CN102711522B (zh) | 2015-09-09 |
EP2461704B1 (en) | 2013-10-09 |
RU2012125878A (ru) | 2014-03-10 |
HK1171342A1 (en) | 2013-03-28 |
WO2011094548A1 (en) | 2011-08-04 |
ES2436890T3 (es) | 2014-01-07 |
AU2011210682A1 (en) | 2012-07-05 |
JP2013517805A (ja) | 2013-05-20 |
ECSP12012051A (es) | 2012-08-31 |
CN102711522A (zh) | 2012-10-03 |
US20110256272A1 (en) | 2011-10-20 |
SG182808A1 (en) | 2012-09-27 |
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