TW201531235A - 益生菌安定化 - Google Patents
益生菌安定化 Download PDFInfo
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- TW201531235A TW201531235A TW103139378A TW103139378A TW201531235A TW 201531235 A TW201531235 A TW 201531235A TW 103139378 A TW103139378 A TW 103139378A TW 103139378 A TW103139378 A TW 103139378A TW 201531235 A TW201531235 A TW 201531235A
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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 COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
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- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/115—Fatty acids or derivatives thereof; Fats or oils
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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 COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
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- A—HUMAN NECESSITIES
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Abstract
一種可攝食之組成物,其包括含納於磷脂質及甘油酯之混合物中的益生菌且可用於嬰兒及孩童營養。
Description
本發明關於用於個體攝取之生物材料之安定化。更特定言之,本發明說明關於一種安定化混合物,該安定化混合物包含至少一種磷脂質及至少一種甘油酯,當益生菌有機體包括於營養組成物中時,該至少一種磷脂質及至少一種甘油酯一同將經改善之安定性提供予該益生菌。本發明亦包括益生菌安定化方法。
目前有各種用於補充物人及動物兩者之營養的組成物。這些補充物可經提供以改變、減少或增加個體腸道內的微生物叢,以造成對消化的所欲之效果。理想上,針對包括人之個體,基於改變人胃腸(GI)道內特定細菌,補充物可培養經改善之微生物叢。此型式之補充物可透過使用益生菌而進行,該益生菌已知為活微生物,當其投與有效量,會賦予宿主健康或營養益處。較常見的益生菌類型之一係可將糖及其他碳水化合物轉化成乳酸之乳酸細菌。此轉化使宿主腸道內的pH降低,並提供較少機會
透過胃腸感染使有害生物體生長及造成問題。
常見技術挑戰係以適當方式將益生菌引入宿主中,以供兼具益生菌的維持和個體的健康及愉悅。目前技術包括該利用膠囊化(encapsulation)及安定化技術,以保護層或基質供屏蔽該益生菌之用,而使該經保護之微生物可通過至個體GI道內的適當位置。
雖然已有開發有關用於含納供投遞至動物消化系統之微生物的膠囊化及安定化技術,但少有開發於分配及儲存期間保護益生菌存活性之膠囊化或安定化技術。針對可用於情況不利冷凍且又此等配方品會經曝露至各種環境、特別是與熱帶氣候有關之安定化技術有需求。此外,該產品之固有濕分會構成挑戰,因為益生菌通常對水敏感、加上高溫時尤甚之。迄今,未找出技術或技法以當在中度濕氣條件(即約0.2及更高、且達至約0.4或更高之水活性)及高溫下於分配及儲存期間(即至少約30℃、且達至並超過40℃之溫度)將益生菌併入營養配方時對益生菌投遞足夠的保護。
特定言之,益生菌可提供予宿主各種益處,諸如維持健康的胃腸菌叢、增強免疫性、保護以免腹瀉、異位性皮膚炎及其他疾病等等。如上所述,需要於有損該益生菌存活性之包括熱帶氣候的各種地理區域投與益生菌。習知的膠囊化及安定化技術具有不適宜用於嬰兒配方及/或供孩童使用之化學組成,或已知的技術具有不良安定特性而大大地限制商業化機會。
因此,所欲者為一種安定化技術及經安定化之細菌混合物,其使用嬰兒配方或孩童營養可接受之成分,該經安定化之混合物能改善安定性性質而使益生菌可於廣泛各種地理位置及氣候而分配同時維持可用之保存期限。又,所欲者係一種用於保護諸如鼠李糖乳酸桿菌(Lactobacillus rhamnosus)之用於像是嬰兒配方、補充物及孩童產品之營養組成物的益生菌之安定化技術。事實上,包括經改善之安定性併以營養因子之特性組合,提供經改善之安定化混合物,其可應用於出生前、嬰兒、及孩童營養。
在一些實施態樣中,本發明係關於一種包含蛋白質來源及益生菌之營養組成物,其中該益生菌經安定化於保護性基質中,該保護性基質包括至少一種磷脂質及至少一種甘油酯。
在此等實施態樣中,該營養組成物包含存活性微生物細胞,諸如存活性鼠李糖乳酸桿菌細胞。又,該基質可包含水解蛋白質來源、果膠、另外之脂質、或彼等之任何組合。該營養組成物可為粉末配方,諸如粉末嬰兒配方。另,該至少一種甘油酯可包括單甘油酯、雙甘油酯、或彼等之任何組合。
在另一實施態樣中,本發明係關於一種用於保護供使用於粉末營養組成物中的存活性益生菌之方法,
該方法包括下列步驟:(i)提供存活性益生菌;(ii)藉由將至少一種磷脂質及至少一種甘油酯摻合一起而製備供益生菌之用的保護性基質;以及(iii)將該存活性益生菌、該保護性基質及水組合以製造混合物;以及(iv)將該步驟(iii)之混合物乾燥至約4%或更低之最終濕分含量(moisture content)。此方法可包含該下列另外之步驟:a)將該乾燥混合物加至粉末營養產品;或b)將步驟(iv)之乾燥混合物密封於膠囊中。在此實施態樣中,該存活性益生菌可為鼠李糖乳酸桿菌、長雙叉桿菌BB536(Bifidobacterium longum BB536)、長雙叉桿菌嬰兒亞種35624(Bifidobacterium longum subsp.infantis 35624)、動物雙叉桿菌乳酸亞種BB-12(Bifidobacterium animalis subsp.lactis BB-12)、或彼等之任何組合。
這些態樣及其他者為熟悉本技術者於審閱下列說明而更為清晰,可藉由而提供磷脂質及生物材料混合物以供安定化諸如益生菌之生物材料而完成,以提供經提升之生物材料安定性,產生經改善之生物材料長期存活性。在一實施態樣中,該安定化混合物有利地提供益生菌保存期限的延長。該安定化混合物可以各種方法與益生菌組合,該些方法包括凍乾、風乾、真空乾燥、噴霧乾燥及任何彼等之組合,以供保藏益生菌。
應了解的是,上述之一般說明及下列之詳細說明兩者均提供本發明之實施態樣,且意欲提供了解本案所請之發明的本質及特性之概覽或架構。
現將詳細參照本發明之實施態樣,在下文會說明一或多個實施例。各實施例係提供用來解釋本發明之營養組成物,而非限定本發明。事實上,熟悉本技術領域者將清楚瞭解可在未悖離本發明之範圍下對本揭露之教示作各種修飾或變異。例如,經繪示或描述作為一實施態樣的一部分之特徵,可與另一實施態樣併用,以產生又另一實施態樣。
因此,本發明意欲將這類修飾及變異包含在後附之申請專利範圍及其等效物的範圍內。本發明之其他目的、特徵、及態樣揭示於下列詳細說明中,或可從下列詳細說明中清楚明白。本發明所屬技術領域中具有通常知識者可了解本討論內容僅說明例示性實施態樣,且不欲作為限制本發明之較廣態樣。
本發明提供一種安定化技術及一種經安定化之混合物(在本文中亦稱為“安定化混合物”或“保護性基質”),其可使用以供改善生物材料之安定性(在本文中亦稱為“底質(substrate)”)。在本發明之實施態樣中,該經安定化之底質可為益生菌,其中各種與該經安定化之益生菌有關之健康效益可於攝食含有該經安定化之益生菌之營養組成物而賦予個體。
雖然益生菌業經認定具營養益處,但其通常被認為,若當微生物仍存活時益生菌微生物被個體攝取,
益生菌的有益效果會最大化。因此,理想的是存活性益生菌在產品被攝取及引入個體胃腸道前存活於製造及置於可消費營養組成物(諸如食物或飲料)中的條件,和存活於後續運送及儲存時間。在理解大量細胞最終失去存活性並於製造過程、運輸、及儲存期間死亡,許多習知益生菌組成物利用極高計數之存活性細胞。
藉由實施本發明,包含至少一種磷脂質及/或至少一種甘油酯之脂質組份係併入保護基質中。該磷脂質及/或甘油酯增加該藉由基質所保護之益生菌的安定性。因此,嬰兒及孩童可相容之益生菌可以包括至少一種磷脂質及/或至少一種甘油酯之基質而安定化。在一些實施態樣中,該基質另包含至少一種另外之脂質,即,至少一種除了該磷脂質及甘油酯以外之脂質。由於該益生菌展現經改善之存活性,該經安定化之益生菌可使用於多種環境中。有利的是,由於該經安定化之混合物的經改善之安定性,該益生菌即使在長距離運送及儲存時間仍維持存活性,因此藉由本發明之保護基質所安定化之益生菌可併入營養組成物中並於面臨潛在損害溫度波動的長距離運送。
本提供益生菌安定化之方法可包括使用供安定化生物材料之用的基質,其中該基質包括磷脂質、甘油酯、及另外之組分,諸如一或多種另外之脂質、一或多種碳水化合物及/或化合物黏合劑。
雖然該保護基質可用於各種物質,但在一實施態樣中,其用於保護至少一種益生菌,諸如鼠李糖乳酸
桿菌。鼠李糖乳酸桿菌已理解具有相對良好生物安定性,同時對人小腸黏膜細胞具有高結合性(avidity)。在用作為益生菌中,鼠李糖乳酸桿菌被認為於消化道拓殖(colonize)並平衡小腸微生物叢。
該保護基質提供益生菌之經改善之安定性,意指在加工、運輸及儲存條件後,較大百分比之該益生菌細胞為存活者。特定言之,當相較於其他已知的安定化技術,存活性益生菌的保存期限有改善。
本發明之保護基質可用於多種供形成經安定化之益生菌產品之方法。這些方法包括冷凍、急驟冷凍、凍乾、環境風乾、真空乾燥、噴霧乾燥、低溫乾燥、及彼等之任何組合。該獲得的經安定化之益生菌,不論為單獨或整合至營養組成物中,在廣範圍之溫度及病況中具有有效存活性,同時展現經改善之保存期限。再者,該經安定化之益生菌可併入各種出生前、嬰兒及孩童營養產品,以供改善他們的腸道微生物叢,同時將營養提供予嬰兒或孩童。
因此,在一個實施態樣中,本發明係關於一種用於安定化生物材料於營養組成物中之方法。又另一實施態樣係用於益生菌之保護基質。進一步實施態樣係增加益生菌保存期限之方法,其包含以安定化混合物來安定化該益生菌,該安定化混合物包括磷脂質、甘油酯或彼等之任何組合。
本發明提供新穎安定化混合物及方法,其提
供諸如存活性微生物之生物材料安定性及保護。本發明包括安定化混合物,其包含磷脂質、及甘油酯,彼等一起提供保護基質,其較未經保護之益生菌產生經提升之保存期限。
該術語“保護性基質”、“安定化基質”、及“安定化混合物”在本發明全文係交換使用。
如本文中所使用,“有效量”係通常界定為於投與至個體中提供可觀察結果的用劑量。
“營養組成物”意指滿足至少一部分個體營養素需求之物質或配方品。術語“營養”、“營養配方”、“腸道營養”、及“營養補充物”係用作為本發明整體之營養組成物的非限制實例。再者,“營養組成物”可指液體、粉末、凝膠、糊劑、固體、濃縮物、懸浮液、或即用形式之腸道配方、口服配方、嬰兒用配方、小兒個體用配方、孩童用配方、成長乳、和/或成人用配方。
術語“腸道(的)”意指可透過胃腸或消化道或於胃腸或消化道內投遞的。“腸道投與”包括口服餵食、胃內餵食、經由幽門(transpyloric)投與、或任何其他投與至消化道中。“投與”較“腸道投與”廣義,且包括非經腸道投與或任何物質攝入個體體內的其他投與途徑。
“小兒個體”意指年齡小於13歲的人。在一些實施態樣中,小兒個體係指小於8歲的人個體。在其他實
施態樣中,小兒個體係指介於1及6歲之間的人個體。在又進一步之實施態樣中,小兒個體係指介於6及12歲之間的人個體。
“嬰兒”意指年齡範圍在出生至不大於一歲的人個體,且包括矯正年齡(corrected age)為0至12個月的嬰兒。短語“矯正年齡”意指嬰兒的出生後年齡(chronological age)扣除嬰兒未成熟出生的時間數。因此,若嬰兒足月出生,矯正年齡係嬰兒的歲數。嬰兒一詞包括低出生體重嬰兒、極低出生體重嬰兒、及早產嬰兒。“早產嬰兒”係少於約37週妊娠後出生的嬰兒。如本文中所使用,“足月產嬰兒”係至少約37週妊娠後出生的嬰兒。
“孩童”意指年齡範圍在12個月至約12歲的個體。在一些實施態樣中,孩童係年齡介於1及12歲之間的個體。在其他實施態樣中,術語“孩童”係指介於一歲及約六歲、或介於約七歲及約12歲的個體。在其他實施態樣中,術語“孩童”係指任何介於12個月及約12歲之間的年齡範圍者。
“孩童營養產品”係指滿足至少一部分孩童營養需求之組成物。成長乳(GUM)係孩童營養產品的實例。
如本文中所使用,“經水解之蛋白質”意指蛋白質水解之產物。於本發明中,經水解之蛋白質及蛋白質水解產物係交換使用以描述蛋白質水解產物;經大量水解蛋白質係使用以描述至少70%、更佳為至少約90%的經水解之蛋白質具有小於2000道耳頓之分子量的蛋白質水解
產物。
術語“水解度”係指肽鍵藉由水解方法斷裂的程度。
術語“不含蛋白質”意指當藉由標準蛋白質檢測法(諸如十二烷基(月桂基)硫酸鈉-丙烯醯胺凝膠電泳法(SDS-PAGE)或粒徑篩析層析術(size exclusion chromatography))時無法測量到其蛋白質含量。在一些實施態樣中,該營養組成物係實質上不含蛋白質,其中“實質上不含”係定義於下文。
“嬰兒配方”意指滿足至少一部分嬰兒營養需求之組成物。在美國,嬰兒配方的內容物係由美國聯邦法規第21篇第100、106、及107節所列之聯邦法規所規定。這些法規定義巨量營養素、維生素、礦物質、及其他成分量,以致力於模擬人乳的營養及其他性質。
術語“成長乳”係指意欲被用作為多樣性膳食的一部分的廣泛範疇之營養組成物,以便支持年齡介於約1及約6歲的孩童之正常生長及發育。
“以乳為底質的”意指包含至少一種已從哺乳動物之乳腺提取出或萃取出之組分。在一些實施態樣中,以乳為底質之營養組成物包含源自圈養有蹄類動物、反芻動物、或其他哺乳動物、或彼等之任何組合的乳品組分。再者,在一些實施態樣中,以乳為底質意指包含牛酪蛋白、乳清、乳糖、或彼等之任何組合。此外,“以乳為底質之營養組成物”可指包含本技術領域中已知之任何源自乳品
或以乳為底質之產品的任何組成物。
“營養完整的”意指可作為唯一之營養來源的組成物,該組成物可實質上提供所有每日需要量之維生素、礦物質及/或微量元素,加上蛋白質、碳水化合物和脂質。事實上,“營養完整的”描述提供支持個體正常生長及發育所需之適量的碳水化合物、脂質、必需脂肪酸、蛋白質、必需胺基酸、條件性必需胺基酸、維生素、礦物質和能源的營養組成物。
對早產嬰兒“營養完整”之組成物將定義為定性且定量地提供早產嬰兒成長所需之適量的所有碳水化合物、脂質、必需脂肪酸、蛋白質、必需胺基酸、條件性必需胺基酸、維生素、礦物質、和能源。對足月產嬰兒“營養完整”之組成物將定義為定性且定量地提供足月產嬰兒成長所需之適量的所有碳水化合物、脂質、必需脂肪酸、蛋白質、必需胺基酸、條件性必需胺基酸、維生素、礦物質、和能源。對孩童“營養完整”之組成物將定義為定性且定量地提供孩童成長所需之適量的所有碳水化合物、脂質、必需脂肪酸、蛋白質、必需胺基酸、條件性必需胺基酸、維生素、礦物質、和能源。
如應用於營養素,術語“必需”係指任何無法由身體合成足以用於正常生長及維持健康的量而因此必須由膳食供應之營養素。術語“條件性必需”如應用於營養素則意指該營養素在發生身體無法獲得適量前驅物化合物以供內源性合成時的條件下必須藉由膳食來供應。
術語“益生菌”意指對宿主健康賦予有益效果之具有低或無致病性的微生物。“存活性益生菌”意指對宿主健康賦予有益效果之活的或活性微生物。
術語“去活化益生菌”或“去活化LGG”意指所指涉之益生菌或鼠李糖乳酸桿菌GG(LGG)有機體的代謝活性或繁殖能力已被降低或破壞之益生菌。在一實施態樣中,該益生菌可為存活性或非存活性。如本文中所使用,術語“存活性”係指活微生物。術語“非存活性”或“非存活性益生菌”意指非活益生菌微生物、它們的細胞組成及/或彼等之代謝物。此等非存活性益生菌可已經熱殺除或其他去活化,但它們留存有利影響宿主健康的能力。可用於本揭露之益生菌可為天然存在、合成或透過基因操作生物體開發,不論此種來源為現在己知或後來所開發者。
“益生素(prebiotic)”意指一種非可消化性食品成分,其藉由選擇性刺激消化道中可改善宿主健康的一種或有限種細菌之生長及/或活性而對宿主具有益影響。
“植物營養素”意指天然存在於植物中之化學化合物。植物營養素可能被包含在任何源自植物之物質或萃取物中。術語“植物營養素”包含數種由植物製造之廣大類別的化合物,例如像是多酚系化合物、花青苷類(anthocyanins)、原花青素類(proanthocyanidins)及黃烷-3-醇類(flavan-3-ols)(即兒茶素類(catechins)、表兒茶素類(epicatechins)),且可源自例如果實、種子或茶萃取物。又,植物營養素一詞包括所有類胡蘿蔔素類、植物固醇
類、硫醇類、及其他源自植物之化合物。
“β-葡聚糖”意指所有β-葡聚糖,包括特定類型之β-葡聚糖,諸如β-1,3-葡聚糖或β-1,3;1,6-葡聚糖。再者,β-1,3;1,6-葡聚糖係β-1,3-葡聚糖型。因此,該術語“β-1,3-葡聚糖”包括β-1,3;1,6-葡聚糖。
“果膠”意指任何天然存在之寡醣或多醣,其包含可在植物細胞壁中找到之半乳糖醛酸。再者,果膠可包含具有藉由D-半乳糖醛酸哌喃糖苷基(D-galacturonopyranosyl)所形成之多樣鏈長之分子。具有不同物理及化學性質的不同變異及等級之果膠為本技術領域中已知者。事實上,植株之間、組織之間、甚至在單一細胞壁內的果膠結構可以有顯著的不同。一般而言,果膠係由帶負電荷之酸性糖類(半乳糖醛酸)組成,且該酸性基團中一些為甲酯基團之形式。果膠之酯化度為接附至半乳哌喃糖苷基糖醛酸(galactopyranosyluronic acid)單元之羧基基團被甲醇酯化之百分比的測量值。
酯化度小於50%(即,少於50%之羧基基團被甲基化以形成甲酯基團)之果膠被歸類為低酯、低甲氧基或低甲基化(“LM”)果膠,而酯化度為50%或更高(即,超過50%之羧基基團被甲基化)之果膠被歸類為高酯、高甲氧基或高甲基化(“HM”)果膠。非常低(“VL”)果膠(其為低甲基化果膠的次類)之酯化度小於約15%。又,在一些實施態樣中,果膠分子具有與自身及/或與諸如鈣之二價陽離子交互作用的能力,透過靜電交互作用以形成高分子量
網絡及凝膠。酯化度影響這些分子間相互作用的程度。
“脂質”係指疏水性分子,其可包括游離脂肪酸及/或其中脂肪酸酯化下列之羥基的分子:(i)醣(諸如單-或雙醣)、(ii)醇(其中該醇可包含例如長-或中等碳鏈長度(10-20個單元))、或(iii)甘油。這些酯化或游離脂肪酸可為直鏈、飽和或不飽和。又,在一些實施態樣中,該脂質組分包含甘油酯、磷脂質、神經胺醇衍生分子(諸如神經節苷脂、腦苷脂、以及神經鞘磷脂(sphingomyelin))、或彼等之任何組合。且,在某些實施態樣中,該脂質組分另包括性質為疏水性之分子,諸如類固醇、類胡蘿蔔素類、及/或脂溶性維生素。
“甘油酯”意指任何源自甘油或糖骨架之分子,其中一或多個羥基與脂肪酸酯化。在一些實施態樣中,該甘油酯組分包含單甘油酯、二甘油酯、單糖酯、雙糖酯、或彼等之組合。
“磷脂質”意指任何源自磷脂酸之分子,其中來自甘油骨架之一或二個碳經酯化接上脂肪酸,且末端碳之一者經酯化接上磷酸基團。在某些實施態樣中,該磷酸基團係磷酸二酯,其亦經酯化接上另一功能性分子,諸如膽鹼、絲胺酸、或肌醇。在一些實施態樣中,該磷脂質組分包含甘油磷脂質(glycerophospholipid)及/或磷酸醯化甘油(phosphoacylglycerol)。又,該磷脂質組分可包含溶血磷脂質(lyso-phospholipid),其中來自甘油骨架之一個碳仍為未酯化羥基。且,在一些實施態樣中,該磷脂質組分包
含卵磷脂,其可例如自大豆或自蛋黃萃取並可包含磷脂醯-膽鹼、磷脂醯-肌醇及磷脂醯絲胺酸之組合。在一些實施態樣中,該磷脂質可包含黃豆卵磷脂、蛋卵磷脂、乳脂肪衍生磷脂質或彼等之組合。
除非另有指明,否則本文所使用之所有百分比、份數及比例係按總營養組成物(包括該經安定化之益生菌)之重量計。
所有經指明為"每日"投與之量可在24小時一段時間期間投與一個單位劑量、單一供應量或二或更多個劑量或供應量而投遞。
本發明之營養組成物可為實質上不含任何本文中所述之隨意或經選擇成分,惟該剩餘其他的營養組成物仍含有所有本文中所述之所需成分或特徵。在此前後文、及除非另有指明之下,術語“實質上不含”意指該經選擇之組成物可含有少於功能性含量的隨意成分,典型上少於0.1重量%、且亦包括零重量百分比的此種隨意或經選擇成分。
本揭露所有指涉為單數特性或限制,應包括對應之複數特性或限制,反之亦然,除非另有指明或明確暗示與所指涉之前後文相反。
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,除非另有指明或明確暗示與所指涉之前後文相反。
本發明之方法和組成物(包括其組分)可包含本
文中所述之實施態樣的必要要素和限制、以及本文中所述之任何另外或隨意之成分、組分或限制或其他可用於營養組成物者,或由彼等所組成或實質上由彼等所組成。
如本文中所使用,術語“約”應解讀為指涉經指定作為任何範圍的終點的兩個數值。任何對範圍之引用應被認為係提供對該範圍內之任何次集合的支持。
在本發明之實施中,至少一種磷脂質及至少一種甘油酯係利用作為用於安定化生物材料之保護基質之組分。
於本發明之保護基質中使用磷脂質及/或甘油酯對包括鼠李糖乳酸桿菌之益生菌提供優異保護,係超出本技術領域中已知先前已知者。
該保護基質之脂質組分可包含但不限於動物來源,例如乳脂肪、奶油、奶油脂肪、乳磷脂質、蛋黃脂質、蛋黃磷脂質;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、加拿大菜籽油(canola oil)、葵花油、大豆油、大豆磷脂質、軟棕櫚油(palmolein)、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(palm stearin)、棕櫚仁油、小麥胚芽油;中鏈三酸甘油酯油和脂肪酸之乳劑和酯類;以及彼等之任何組合。
在一些實施態樣中,該安定化混合物包含每
100克於乾量基準之混合物介於約0.5及約50克之間的脂質組分。在某些實施態樣中,該安定化混合物包含每100克於乾量基準之混合物介於約2.5及約30克之間的脂質組分。
該安定化混合物可包含磷脂質組分。在某些實施態樣中,該安定化混合物包括每100克於乾量基準之混合物介於約0.5及約2克之間的磷脂質組分。在一些實施態樣中,該安定化混合物包含每100克於乾量基準之混合物約0.75及約1.25克之間的磷脂質組分。
同樣地,該安定化混合物可包括甘油酯組分。在一些實施態樣中,該安定化混合物包含每100克於乾量基準之混合物約0.5及約2克之間的甘油酯組分。在某些實施態樣中,該安定化混合物包含每100克於乾量基準之混合物約0.75及約1.25克之間的甘油酯組分。再者,該甘油酯組分可包含單甘油酯、雙甘油酯、或彼等之任何組合。
在某些實施態樣中,該安定化混合物之主要組分以乾重基(dry weight basis)為基準計,為一或多種碳水化合物,其可包括多醣、雙醣及單醣。事實上,該保護基質可包括乳果糖、乳果寡糖、棉子糖、葡萄糖寡糖、繭糖(trehalose)、菊糖、聚右旋糖、半乳糖寡糖、果糖寡糖、異麥芽糖寡糖、大豆寡醣、乳果寡糖、木糖寡糖、幾丁寡糖、甘露糖寡糖、阿拉伯糖寡糖、唾液酸寡糖、海藻糖寡糖、龍膽寡糖、及/或任何彼等之組合。在一些實施
態樣中,該保護基質包括選自下列之第一碳水化合物:蔗糖、麥芽糖、乳糖、繭糖、麥芽三糖(maltotriose)、具有約2至約6之右旋糖當量的麥芽糊精、及任何彼等之組合。在某些實施態樣中,該保護基質包括選自下列之第二碳水化合物:菊糖、聚右旋糖、半乳糖寡糖、寡果糖、澱粉、具有大於約8之右旋糖當量的麥芽糊精、及任何彼等之組合。
在一些實施態樣中,該安定化混合物可包含每100克於乾量基準之混合物介於約50及約80克之間的第一碳水化合物;每100克於乾量基準之混合物介於約60及約70克之間的第一碳水化合物;或每100克於乾量基準之混合物介於約65及約70克之間的第一碳水化合物。該第一碳水化合物可選自:蔗糖、麥芽糖、乳糖、繭糖、麥芽三糖、具有約2至約6之右旋糖當量的麥芽糊精、及任何彼等之組合。
該安定化混合物亦可包含每100克於乾量基準之混合物介於約1及約10克之間的第二碳水化合物;每100克於乾量基準之混合物介於約4及約6克之間的第二碳水化合物;或每100克於乾量基準之混合物約5克的第二碳水化合物。在一些實施態樣中,該第二碳水化合物係選自:菊糖、聚右旋糖、半乳糖寡糖、寡果糖、澱粉、具有大於約8之右旋糖當量的麥芽糊精、及彼等之任何組合。
該安定化混合物之進一步組分可為化合物黏
合劑(亦稱為膠化劑),其可作為增稠劑且產生類凝膠之稠度。可包括於本發明之保護基質中的化合物黏結劑包括諸如藻酸鈉之藻酸鹽、果膠、聚葡萄胺糖(chitosan)、羧甲基纖維素、及彼等之混合物,及其他者。該化合物黏合劑之併入提供黏滯稠度形成,該黏滯稠度提供有效基質形成及適用於後續乾燥之結構品質。
在一些實施態樣中,化合物黏合劑可形成類膠材料並增加被加入之混合物的黏度。此外,該化合物黏合劑亦可提供將組分混合一起的較大便利性。例如,藻酸鈉亦可具有乳化劑特性。
在一些實施態樣中,該安定化混合物可包含LM果膠、HM果膠、VL果膠、或彼等之任何混合物。所包括之果膠可溶於水。
用於本文中之果膠典型上具有8,000道耳頓或更大之波峰分子量。本發明之果膠具有介於8,000及約500,000之間、更佳為介於約10,000及約200,000之間、且最佳為介於約15,000及約100,000道耳頓之間的較佳波峰分子量。在一些實施態樣中,本發明之果膠可為經水解之果膠。在某些實施態樣中,該保護基質包含水解果膠具有的分子量小於完整或未經改質之果膠的分子量。本發明之水解果膠可藉由任何本技術領域中已知之手段方法製備以減少分子量。該手段方法的實例為化學水解、酵素水解及機械剪切力。減少分子量之較佳手段方法為在升溫下藉由鹼或中性水解。在一些實施態樣中,該保護基質包含經
部分水解之果膠。在某些實施態樣中,該經部分水解之果膠具有的分子量小於完整或未經改質之果膠的分子量,但大於3,300道耳頓。
該安定化混合物可包含每100克於乾量基準之混合物介於約0.5及約5克之間的化合物黏合劑,諸如藻酸鈉及/或果膠。在某些實施態樣中,該安定化混合物包含每100克於乾量基準之混合物介於約1及約3克之間的化合物黏合劑。且,在一實施態樣中,該安定化混合物包含每100克於乾量基準之混合物約2克的化合物黏合劑。
又,該安定化混合物亦可包含至少一種澱粉、澱粉來源及/或澱粉組分。在一些實施態樣中,該安定化混合物可包含天然或經改質之澱粉,例如像是含蠟玉米澱粉、含蠟稻米澱粉、含蠟馬鈴薯澱粉、含蠟樹薯澱粉、玉米澱粉、稻米澱粉、馬鈴薯澱粉、樹薯澱粉、小麥澱粉或彼等之任何混合物。
該安定化混合物亦可包括對益生菌或攝食該經安定化之益生菌的個體提供進一步益處的另外之成分。這些成分可包含礦物質、維生素、抗氧化劑、微量元素、固醇類、抗氧化劑、脂肪酸、功能性分子、及任何彼等之組合。其他成分可包括抗性澱粉(resistant starch)、高直鏈澱粉澱粉、瓜爾膠(guar)、及刺槐豆膠、洋菜、黃原膠(xanthan)、角叉菜膠、葡聚糖、及任何彼等之組合。
在一些實施態樣中,該安定化混合物可包含
每100克於乾量基準之混合物介於約5及約90克之間的益生菌及/或其他生物材料。在一些實施態樣中,該安定化混合物包含每100克之該安定化混合物介於約50及約90克之間的益生菌及/或其他生物材料。在某些實施態樣中,該安定化混合物包含每100克於乾量基準之混合物介於約9及約12克之間的益生菌及/或其他生物材料。且,在一實施態樣中,該安定化混合物包含每100克於乾量基準之混合物約10.2至約11.4克的益生菌及/或其他生物材料。在另一實施態樣中,在該保護基質內的例如LGG之益生菌的濃度係每克的保護基質約1×106至約1×1014cfu、更佳為每克的保護基質約1×109至約1×1011cfu。
該安定化混合物可使用以提供益生菌有機體安定性,該益生菌有機體可對個體健康及福利賦予有益效果。適合的益生菌之實例包括但不限於酵母菌,諸如釀酒酵母菌、黴菌,諸如麴菌屬(Aspergillus)、黑黴菌屬(Rhizopus)、白黴菌屬(Mucor)、及細菌,諸如乳酸桿菌屬。適合的益生菌微生物之特定實例為:黑麴菌(Aspergillus niger)、綠麴菌(A.oryzae)、凝結芽孢桿菌(Bacillus coagulans)、緩慢芽孢桿菌(B.lentus)、地衣芽孢桿菌(B.licheniformis)、馬鈴薯芽孢桿菌(B.mesentericus)、短小芽孢桿菌(B.pumilus)、枯草芽孢桿菌(B.subtilis)、納豆芽孢桿菌(B.natto)、青少年雙叉桿菌(Bifidobacterium adolescentis)、動物雙叉桿菌(B.animalis)、短雙叉桿菌(B.breve)、分裂雙叉桿菌(B. bifidum)、嬰兒雙叉桿菌(B.infantis)、乳雙叉桿菌(B.lactis)、長雙叉桿菌(B.longum)、長雙叉桿菌BB536(B.longum BB536)、長雙叉桿菌AH1206(NCIMB:41382)(B.longum AH1206(NCIMB:41382))、短雙叉桿菌AH1205(NCIMB:41387)(B.breve AH1205(NCIMB:41387))、嬰兒雙叉桿菌35624(NCIMB:41003)(B.infantis 35624(NCIMB:41003))、長雙叉桿菌AH1714(NCIMB 41676)(B.longum AH1714(NCIMB 41676))、動物雙叉桿菌乳酸亞種BB-12(DSM No.10140)(B.animalis subsp.lactis BB-12(DSM No.10140))、假長雙叉桿菌(B.pseudolongum)、嗜熱雙叉桿菌(B.thermophilum)、平托念珠菌(Candida pintolepesii)、酪酸梭菌(Clostridium butyricum)、乾酪腸球菌(Enterococcus cremoris)、丁二酮乳腸球菌(E.diacetylactis)、屎腸球菌(E.faecium)、間腸球菌(E.intermedius)、乳腸球菌(E.lactis)、蒙氏腸球菌(E.muntdi)、嗜熱腸球菌(E.thermophilus)、嗜酸乳酸桿菌(Lactobacillus acidophilus)、食物乳酸桿菌(L.alimentarius)、澱粉分解乳酸桿菌(L.amylovorus)、卷曲乳酸桿菌(L.crispatus)、短乳酸桿菌(L.brevis)、乾酪乳酸桿菌(L.case)、彎乳酸桿菌(L.curvatus)、纖維雙醣乳酸桿菌(L.cellobiosus)、德氏乳酸桿菌保加利亞亞種(L.delbrueckii ss.bulgaricus)、香腸乳酸桿菌(L.farciminis)、發酵乳酸桿菌(L.fermentum)、蓋氏乳酸桿菌(L.gasseri)、瑞士乳酸桿菌(L.helveticus)、乳酸乳酸桿菌
(L.lactis)、胚芽乳酸桿菌(L.plantarum)、強森氏乳酸桿菌(L.johnsonii)、路透氏乳酸桿菌(L.reuteri)、鼠李糖乳酸桿菌(L.rhamnosus)、鼠李糖乳酸桿菌GG(ATCC number 53103)(Lactobacillus rhamnosus GG(ATCC number 53103))、清酒乳酸桿菌(L.sakei)、唾液乳酸桿菌(L.salivarius)及彼等之任何組合。在一實施態樣中,該經安定化之益生菌可為存活性或非存活性。可用於本發明之經安定化之益生菌可為天然存在、合成或透過基因操作生物體開發,不論此新穎來源為現在己知或後來所開發者。
在本發明之實施態樣中,鼠李糖乳酸桿菌GG係利用作為可藉由本發明之保護基質而安定化之益生菌。鼠李糖乳酸桿菌GG描述於美國專利申請案4,839,281,由Sharwood等人發表,該案以引用方式全部併入本案。值得注意的是,Sharwood等人描述鼠李糖乳酸桿菌GG為具有強烈附著至小腸細胞同時能在低pH存活並製造大量乳酸之細菌菌種。
與本發明之安定化混合物組合之前,該經選擇之益生菌較佳為經濃縮至類似濕潤糊劑稠度。以乾燥形式益生菌開始係替代選擇。雖然取決於該特定益生菌生質及後續加工步驟可包括較小或較大濃縮,但經選擇之益生菌的濃縮量包括約3X至約20X的濃縮。
通常,製備經安定化之益生菌包括下列步驟:濃縮該經選擇之益生菌或多種益生菌;以所欲之量提供安定化混合物之組分;將該安定化混合物與該經濃縮之
益生菌混合;乾燥該經安定化之益生菌並包裝或將該經安定化之益生菌組合成營養產品,諸如嬰兒配方。
在一些實施態樣中,本發明係關於一種用於保護供使用於營養組成物中之存活性益生菌之方法,該方法可包括下列步驟:提供存活性益生菌、藉由摻合(i)磷脂質組分及(ii)甘油酯組分及任何彼等之組合而製備用於該益生菌之保護基質、接著將該存活性益生菌、該保護基質及水組合以製造混合物及乾燥該混合物至約4%或更低之最終濕分含量、以及另將該乾燥混合物加至粉末營養產品或膠囊。
在最佳化該益生菌之安定化中,在如本文所述之一些實施態樣中及如表1-4中所示,多重組成分可各異。在一些實施態樣中,該脂質可占該安定化混合物的約10%至50%(w/w)。在一些實施態樣中,該安定化混合物可包含約5%至約25%(w/w)的磷脂質組分,及約5%至約25%(w/w)的甘油酯組分。在其他實施態樣中,該安定化混合物可包含約5%至約25%(w/w)的磷脂質組分、約2.5至約12.5%(w/w)的甘油酯組分、以及約2.5%至約12.5%(w/w)的另外之/其他脂質組分。在又進一步實施態樣中,該安定化混合物的總脂質可包含約3%至約17%(w/w)的磷脂質組分、約3至約17%(w/w)的甘油酯組分、及約3%至約17%(w/w)的另外之/其他脂質組分。
該經安定化之益生菌可經包裝及商業銷售,
抑或可與各種營養產品組合或與諸如二十二碳六烯酸之其他功能性組分膠囊化。此等營養產品可包括嬰兒配方及孩童產品兩者,其可用於應用在宜將益生菌併入必須有經改善之保存期限及安定性營養產品者。
表1顯示根據本發明之經安定化的益生菌混合物/保護基質之例示實施態樣。
表2顯示根據本發明之經安定化的益生菌混合物/保護基質之例示實施態樣。
表3顯示根據本發明之經安定化之益生菌混合物/保護基質的又另一例示實施態樣。
表4亦提供根據本發明之經安定化之益生菌混合物/保護基質的例示實施態樣。
如上述所製備之經安定化/保護之益生菌可與營養產品組合以形成新穎營養組成物。
舉例而言,該經安定化之益生菌可與諸如嬰兒配方或孩童營養產品之營養產品組合,以形成經安定化之營養組成物。在另一實施態樣中,該經安定化之益生菌可與加至人乳以增強人乳營養值之人乳強化營養品組合。
又,本發明之經安定化之益生菌可與提供最小、部分、或全部營養支持之營養產品組合。此等營養產品可為營養補充物或正餐替代物。事實上,該經安定化之益生菌可在個體攝取前與食物或其他營養產品攪和
(intermix)。
用於與該經安定化之益生菌組合之營養產品可以、但不必須是營養完整。同樣地,該經安定化之益生菌與營養產品之組合可製造營養完整之營養組成物。在一實施態樣中,本發明之營養組成物係營養完整且含有適合種類及量的脂質、碳水化合物、蛋白質、維生素、及礦物質。
本發明所創造之經安定化之益生菌可與以任何本技術領域中已知的形式提供之營養產品組合,包括粉末、凝膠、懸浮液、糊劑、固體、液體、液體濃縮物、或即用產品。在一個組合中,該營養產品係嬰兒配方,特別是經調適以用於作為嬰兒唯一來源營養之嬰兒配方。
用於與該經安定化之益生菌組合之營養產品可為腸道投與。
同樣地,如上述所製備之經安定化/保護之益生菌可與營養產品組合以形成新穎營養組成物。
該營養組成物可包含任何本技術領域中所已知或使用的另外之脂肪或脂質來源,其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、加拿大菜籽油(canola oil)、葵花油、大豆油、軟棕櫚油(palmolein)、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(palm stearin)、棕櫚仁油、小麥胚芽油;中鏈三酸甘油酯油和脂肪酸之乳劑和酯類;以及彼等之任何組合。該營養組成物中的脂質或脂肪量典型上約1至約7g/100kcal不等。
又,該營養組成物可包含牛乳蛋白來源。牛乳蛋白來源可包括但不限於乳蛋白粉末、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、酪蛋白鹽(例如酪蛋白鈉、酪蛋白鈣鈉、酪蛋白鈣)、及任何彼等之組合。
在某些實施態樣中,該營養組成物可包含完整蛋白質。在其他實施態樣中,該營養組成物之蛋白質係以完整蛋白質及水解度介於約4%及10%之間的經部分水解之蛋白質兩者的組合提供。這些實施態樣的某些者可為極度低致敏性,因為該安定劑及該營養產品之蛋白質僅含有經水解之蛋白質。在又另一實施態樣中,該營養組成物可以含麩醯胺酸胜肽來補充。
該營養組成物的蛋白質來源的乳清:酪蛋白比例可類似於人乳中觀察到的比例。在一實施態樣中,該營養組成物之蛋白質來源包含約40%至約80%乳清蛋白。在另一實施態樣中,該蛋白質來源可包含約20%至約60%酪蛋白。該營養組成物中的蛋白質量典型上約1至約7g/100kcal不等。
在其他實施態樣中,該營養組成物包含乳鐵
蛋白,其在人腸道中保留其安定性及活性來抵抗某些不良細菌病原體。
本文中所述之該營養組成物在在一些實施態樣中亦包含非人乳鐵蛋白、藉由基改生物所製造之非人乳鐵蛋白、及/或藉由基改生物所製造之人乳鐵蛋白。乳鐵蛋白通常描述為一種80千道耳頓的醣蛋白,其具有二個幾近相同葉部之結構,該兩者均包括鐵結合位。如於“Perspectives on Interactions Between Lactoferrin and Bacteria”(其出現於刊物:BIOCHEMISTRY AND CELL BIOLOGY,pp 275-281(2006))中所述,雖然通常具有相對高的等電點,在內葉部的末端區域帶有正電荷胺基酸,但來自不同宿主物種之乳鐵蛋白在胺基酸序列可各異。乳鐵蛋白業經認為具有殺細菌及抗微生物活性。在至少一個實施態樣中,該乳鐵蛋白係牛乳鐵蛋白。
令人驚訝地,包括在本文中之乳鐵蛋白形式即使經曝露於經預期會破壞或嚴重地限制人乳鐵蛋白或重組人乳鐵蛋白安定性或活性的低pH(即低於7,且甚至低至約4.6或更低)及/或高溫(即超過65℃,且高至約120℃)條件,仍維持某些相關活性。在某些用於本文中所述之營養組成物類型的加工處理方案期間,可預期這些低pH及/或高溫條件,諸如巴斯德殺菌法。
在一個實施態樣中,乳鐵蛋白係以約5mg/100kcal至約16mg/100kcal的量存在於該營養組成物中。在另一實施態樣中,乳鐵蛋白係以約9mg/100kcal
至約14mg/100kcal的量存在中。在又進一步實施態樣中,該營養組成物可包含每100kcal約2mg至約200mg乳鐵蛋白。且,在某些實施態樣中,該營養組成物可包含介於每100kcal約90mg至約148mg乳鐵蛋白。
該營養組成物亦可含有TGF-ß。在一些實施態樣中,該TGF-ß的量可為約0.0150(pg/μg)ppm至約0.1000(pg/μg)ppm。在其他實施態樣中,該TGF-ß於包括經安定化益生菌之最終組成物的量係約0.0225(pg/μg)ppm至約0.0750(pg/μg)ppm。
在本營養組成物之一些實施態樣中,該TGF-ß的量為約2500pg/mL至約10,000pg/mL、更佳為約3000pg/mL至約8000pg/mL。在一實施態樣中,TGF-ß1:TGF-ß2之比例係在約1:1至約1:20的範圍中,或,更特定言之,在約1:5至約1:15的範圍中。
在一些實施態樣中,該TGF-ß之生物活性於營養組成物中係藉由加入生物活性乳清流份(fraction)而增強。任何本技術領域中已知的生物活性乳清流份可使用於此等實施態樣中,惟其達到所意欲之結果。在一實施態樣中,此生物活性乳清流份可為乳清蛋白濃縮物。在一特定實施態樣中,該乳清蛋白濃縮物可為Salibra®800,可Glanbia Nutritionals自獲得。
該營養組成物可包含除了該經安定化之益生菌之外的益生菌量。當該經安定化之益生菌係與該營養產品組合時,該獲得之營養組成物可包括有效提供個體每
kg體重每日約1×104至約1×1010菌落形成單位(cfu)之益生菌的總量。在其他實施態樣中,該益生菌的量可為每kg體重每日約1×106至約1×109cfu的益生菌不等。在又另一實施態樣中,該營養組成物可包括有效提供個體每kg體重每日約1×106cfu之益生菌的總量。
在某些實施態樣中,本發明之營養組成物包含每100kcal該組成物介於約1×106cfu益生菌及約1×1010cfu之間。在一些實施態樣中,該益生菌的量可為於每100kcal該組成物約1×106cfu至約1×109cfu的範圍中。此外,該營養組成物可包括未經安定化之益生菌,該最終組成物包括一些經安定化之益生菌及一些未經安定化之益生菌。
該營養組成物可另包含至少一種益生素。該術語“益生素”如本文中所使用,係指可攝食之食物成分,其對宿主發揮健康效益。此等健康效益可包括但不限於選擇性刺激一或有限數量之有益腸道細菌的生長及/或活性、刺激經攝食之益生菌(經安定化之或未經安定化)微生物的生長及/或活性、選擇性減少腸道病原體、以及對腸道短鏈脂肪酸分布數據變化(profile)較佳影響。此等益生素可為天然存在、合成、或透過基因操作有機體和/或植物而開發,不論此種新來源為現在己知或後來所開發者。益生素可包括寡醣、多醣、以及其他含有果糖、木糖、大豆、半乳糖、葡萄糖、及甘露糖之益生素。更特定言之,可用於本發明之益生素可包括乳果糖(lactulose)、乳果寡
糖(lactosucrose)、棉子糖、葡萄糖寡糖、菊糖、聚右旋糖、聚右旋糖粉末、半乳糖寡糖、果糖寡糖、異麥芽糖寡糖、大豆寡糖、乳果寡糖、木糖寡糖、幾丁寡糖(chito-oligosaccharide)、甘露糖寡糖、阿拉伯糖寡糖、唾液酸寡糖、海藻糖寡糖、及龍膽寡糖(gentio-oligosaccharide)、及彼等之組合。
在一些實施態樣中,在該營養組成物中所存在的益生素總量可為每L組成物(液態形式)約1.0g至約10.0g(1.0g/L to about 10.0g/L of the composition)。在某些實施態樣中,在該營養組成物中所存在的益生素總量可為每L組成物約2.0g至約8.0g。
該營養組成物可包含聚右旋糖(PDX)。若聚右旋糖係使用作為益生素,在一實施態樣中,聚右旋糖於該營養組成物中的量可為約1.0g/L至約4.0g/L的範圍內。若聚右旋糖係使用作為益生素,在包括經安定化之益生菌的組成物之實施態樣中,聚右旋糖於該營養組成物中的量可為約0.1mg/100kcal至約0.5mg/100kcal的範圍內。在另一組成物中,聚右旋糖的量可為約0.3mg/100kcal。在較佳實施態樣中,該益生素的至少20%應包含聚右旋糖(PDX)。
在某些實施態樣中,該營養組成物包含半乳糖寡糖。半乳糖寡糖於該營養組成物中的量可為約0.2mg/100kcal至約1.0mg/100kcal。在其他實施態樣中,半乳糖寡糖於該營養組成物中的量可為約0.1mg/100kcal
至約0.5mg/100kcal。半乳糖寡糖及聚右旋糖亦可以至少約0.6mg/100kcal的總量補充於該營養組成物中。
在一些實施態樣中,該營養組成物包含另外之碳水化合物來源,即,除了其他於本發明全部所述之碳水化合物以外所提供之碳水化合物來源。適合的另外之碳水化合物來源可為任何本技術領域中所使用者,例如乳糖、葡萄糖、果糖、玉米糖漿固體、麥芽糊精、蔗糖、澱粉、稻米糖漿固體等等。該營養組成物中的另外之碳水化合物量典型上可為約5g及約25g/100kcal之間不等。在一些實施態樣中,該碳水化合物的量係介於約6g及約22g/100kcal之間。在其他實施態樣中,該碳水化合物的量係介於約12g及約14g/100kcal之間。
該營養組成物亦可含有包含二十二碳六烯酸(DHA)之長鏈多不飽和脂肪酸(LCPUFA)的來源。其他適合的LCPUFA包括但不限於α-亞麻油酸、γ-亞麻油酸、亞麻油酸、次亞麻油酸、二十碳五烯酸(EPA)及二十碳四烯酸(ARA)。
在一些實施態樣中,該營養組成物可以DHA及ARA兩者補充,且ARA:DHA重量比係約1:3至約9:1。在某些實施態樣中,ARA:DHA比例係約1:2至約4:1。
在該營養組成物中的長鏈多不飽和脂肪酸的量可為5mg/100kcal至約100mg/100kcal不等,更佳為10mg/100kcal至約50mg/100kcal不等。
又,營養組成物可以含有DHA及ARA的油、使用本技術領域中已知的標準技術來補充。作為實例,含有DHA及ARA的油可藉由替代通常會存在於該營養組成物中之整體脂肪摻合物之其餘者的等同量而加至該組成物。
若利用時,該DHA及ARA來源可為任何本技術領域中已知之來源,諸如海洋油、魚油、單細胞油、蛋黃脂質、以及腦脂質。在一些組成物中,該DHA及ARA源自單細胞Martek油、DHASCO®、或彼等之變異。該DHA及ARA可為天然形式,惟該LCPUFA來源的剩餘部分不會導致對嬰兒的任何實質不利效果。或者,該DHA及ARA可以經精製形式使用。
在本營養組成物之一實施態樣中,DHA及ARA的來源為單細胞油,如美國專利第5,374,567;5,550,156;及5,397,591號所教示者,彼等之揭露以引用方式全部併入本文中。
在某些實施態樣中,該營養組成物係可為以乳為底質之營養組成物,其提供物化及生理益處。如本技術領域中已知者,牛乳蛋白包含二個主要組分:酸可溶性乳清蛋白及酸不可溶性酪蛋白,後者占牛乳總蛋白質含量約80%。於進入胃的酸性環境時,酪蛋白沈澱物並與礦物質錯合,形成尺寸及堅實度各異之半固體凝乳。相較於較大、較硬之凝乳,較軟、較小之凝乳讓身體較容易消化。在開發包括但不限於嬰兒配方、醫療食品、未成熟嬰兒配
方之營養組成物,乳凝形成可為重要考量。如上所述,經安定化之益生菌可與包括相較於標準嬰兒配方為較軟及較小凝乳之組成物組合。
一或多種維生素和/或礦物質亦可以足以供應個體每日營養需求的量加至該營養組成物中。本發明所屬技術領域中具有通常知識者應可了解,維生素及礦物質需求會例如依孩童的年齡而各異。例如,嬰兒可具有與年齡介於一歲及十三歲之間的孩童不同的維生素及礦物質需求。因此,本實施態樣不意欲將該營養組成物限制於特定年齡群,而意欲提供可接受之維生素及礦物質需求範圍。
該營養組成物可隨意地包括但不限於下列維生素或彼等之衍生物之一或多者:維生素B1(噻胺、噻胺焦磷酸酯、TPP、三磷酸噻胺(thiamin triphosphate)、TTP、噻胺鹽酸鹽、噻胺硝酸鹽);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、卵核黃素);維生素B3(菸鹼酸(niacin)、菸鹼酸(nicotinic acid)、菸鹼醯胺(nicotinamide)、菸鹼醯胺(niacinamide)、菸鹼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-前驅物色胺酸;維生素B6(吡哆醇、吡哆醛、吡哆胺、吡哆醇鹽酸鹽)、泛酸(泛酸酯(pantothenate)、泛醇(panthenol))、葉酸鹽(葉酸、葉酸素(folacin)、喋醯麩胺酸);維生素B12(鈷胺素、甲基鈷胺素、去氧腺苷鈷胺素、氰基鈷胺素、羥基鈷胺素、腺苷鈷胺素(adenosylcobalamin));生物素;維生
素C(抗壞血酸);維生素A(視網醇、乙酸視網酯(retinyl acetate)、棕櫚酸視網酯(retinyl palmitate)、與其他長鏈脂肪酸之視網酯類、視網醛、視網酸、視網醇酯類);維生素D(鈣化醇、膽鈣化醇、維生素D3、1,25,-二羥基維生素D);維生素E(α-生育酚、α-生育酚乙酸酯、α-生育酚琥珀酯、α-生育酚菸鹼酸酯、α-生育酚);維生素K(維生素K1、葉醌、萘醌、維生素K2、甲萘醌-7、維生素K3、甲萘醌-4、2-甲萘-1,4-二酮、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、及任何彼等之組合。
又,該營養組成物可隨意地包括但不限於下列礦物質或彼等之衍生物的一或多者:硼、鈣、乙酸鈣、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、葡萄糖酸銅、硫酸銅(II)、氟化物、鐵、羰鐵、三價鐵、反丁烯二酸亞鐵、正磷酸鐵、鐵研磨物(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、乙酸鉀、硒、硫、鈉、琥珀酸辛酯磺酸鈉(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。非限制性例示性的礦物質化合物衍生物包括任何礦物質化合物的鹽類、鹼鹽、酯類及螯合物。
礦物質可以諸如磷酸鈣、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(II)、硫酸錳、及亞硒酸鈉的鹽類形式加至營養組成物。另外之維生素及礦物質可如本技術領域中已知者加入。
本發明之營養組成物可隨意地包括一或多個下列調味劑,其包括但不限於:調味萃取物、揮發性油、可可或巧克力調味劑、花生醬調味劑、餅乾碎、香草或任何市售可得之調味劑。可用的調味劑實例包括但不限於純大茴香精、仿香蕉精、仿櫻桃精、巧克力精、純檸檬精、純橘子精、純薄荷精、蜂蜜、仿鳳梨精、仿蘭姆精(imitation rum extract)、仿草莓精、或仿香草精;或揮發性油,例如蜂草油(balm oil)、月桂油、香柑油、雪松木油、櫻桃油、肉桂油、丁香油、或薄荷油;花生醬、巧克力調味劑、香草餅乾碎、奶油糖、太妃糖、及彼等之混合物。調味劑含量可取決於使用之調味劑而有極大差別。調味劑的種類及含量可依本技術領域中已知者選擇。
本發明之營養組成物可隨意地包括一或多種乳化劑,其可為成品的安定性而加入。適合的乳化劑實例包括但不限於卵磷脂(例如來自蛋或大豆)、α-乳白蛋白和/或單及二甘油酯、及彼等之混合物。其他乳化劑係熟悉本技術者明顯易知者,且選擇適合的乳化劑部分取決於配方品及成品。在一些實施態樣中,本發明之營養組成物可包含乳化劑,諸如單-及/或雙甘油酯之檸檬酸酯、單-及/或
雙甘油酯之二乙醯酒石酸酯、及/或經辛烯基琥珀酸酐改質之澱粉。
本發明之營養組成物可隨意地包括一或多種防腐劑,其亦可加入以延長產品保存期限。適合的防腐劑包括但不限於己二烯酸鉀、己二烯酸鈉、苯甲酸鉀、苯甲酸鈉、乙二胺四乙酸二鈉鈣、及彼等之混合物。
本發明之營養組成物可隨意地包括一或多種安定劑。適合用於實施本揭露之營養組成物的穩定劑包括但不限於阿拉伯膠、印度膠、刺梧桐膠、黃蓍膠、瓊脂、富塞蘭藻膠、瓜爾膠、結冷膠、刺槐豆膠、果膠、低甲氧果膠、明膠、微晶型纖維素、CMC(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、DATEM(單及二甘油酯之二乙醯酒石酸酯類)、聚葡糖、角叉菜膠、及彼等之混合物。
本發明之營養組成物可進一步包括至少一種另外之植物營養素,即,除了本文中所述之果膠、澱粉或其他植物營養素組分之外的另一植物營養素組分。於人乳有發現之植物營養素或彼等之衍生物、共軛形式或前驅物係包含於該營養組成物中的較佳者。舉例而言,在一些實施態樣中,本發明之營養組成物在8fl.oz.(流啢)(236.6mL)供應量中,可包含介於約80及約300mg之間之花青苷類(anthocyanins)、介於約100及約600mg之間之原花青素類(proanthocyanidins)、介於約50及約500mg之間之黃烷-3-醇類(flavan-3-ols)、或彼等之任何組合或混合
物。在其他實施態樣中,該營養組成物包含蘋果萃取物、葡萄子萃取物、或彼等之組合或混合物。又,該營養組成物之至少一種植物營養素(phytonutrient)可源自任何水果、葡萄子及/或蘋果或茶萃取物之單一或摻合物。
適用於該營養組成物的另外之植物營養素的實例包括但不限於花青苷類、原花青素類、黃烷-3-醇類(即兒茶素類、表兒茶素類等等)、黃烷酮類、類黃酮類、異類黃酮類、類二苯乙烯化合物(stilbenoids)(即白藜蘆醇等等)原花青素類、花青苷類、白藜蘆醇、槲皮素、薑黃素、及/或彼等之任何混合物,和純化或天然形式植物營養素之任何可能組合。該營養組成物的某些組分、特別是植物性組分,可提供植物營養素之來源。
該營養組成物之植物營養素組分亦可包含柚苷配基(naringenin)、柑果苷素(hesperetin)、花青苷類、槲皮素、番鬱金黃素、表兒茶素、表沒食子兒茶素(epigallocatechin)、表兒茶素-沒食子酸酯(epicatechin gallate)、表沒食子兒茶素-沒食子酸酯(epigallocatechin gallate)或彼等之任何組合。在某些實施態樣中,該營養組成物包含約50及約2000nmol/L之間的表兒茶素、約40及約2000nmol/L之間的表兒茶素沒食子酸酯(epicatechin gallate)、約100及約4000nmol/L之間的表沒食子兒茶素沒食子酸酯(epigallocatechin gallate)、約50及約2000nmol/L之間的柚苷配基(naringenin)、約5及約500nmol/L之間的番鬱金黃素、約40及約4000nmol/L
之間的柑果苷素(hesperetin)、約25及約2000nmol/L之間的花青苷類、約25及約500nmol/L之間的槲皮素、或彼等之混合物。又,該營養組成物可包含植物營養素或彼之親體化合物之代謝物,或其可包含其他類的膳食植物營養素,諸如硫代葡萄糖苷(glucosinolate)或蘿蔔硫素。在某些實施態樣中,該營養組成物包含類胡蘿蔔素類,諸如黃體素、玉米黃質、蝦黃素、茄紅素、β-胡蘿蔔素、α-胡蘿蔔素、γ-胡蘿蔔素、及/或β-隱黃質。
該營養組成物亦可包含異類黃酮類及/或異黃酮類。實例包括但不限於染料木異黃酮(genistein(染料木苷(genistin))、大豆黃酮(daidzein(大豆苷(daidzin))、鷹嘴豆芽素A(biochanin A)、4'-O-甲基大豆黃酮(formononetin)、香豆醇(coumestrol)、德鳶尾素(irilone)、3',4',5,7-四羥異黃酮(orobol)、偽靛藍苷素(pseudobaptigenin)、金鍊豆異黃酮(anagyroidisoflavone)A及B、毛蕊異黃酮(calycosin)、黃豆素黃酮(glycitein)、紫羅蘭素(irigenin)、5-O-甲基染料木異黃酮、紅三葉草素(pratensein)、櫻黃素(prunetin)、psi-鳶尾配質、圓葉異黃酮素(retusin)、鳶尾配質、野鳶尾苷(iridin)、芒柄花苷(ononin)、葛根素(puerarin)、鳶尾黃酮苷(tectoridin)、大魚藤異黃酮(derrubone)、黃花羽扇豆異黃酮(luteone)、6-異戊烯染料木異黃酮(wighteone)、高山異黃酮(alpinumisoflavone)、密毛酮(barbigerone)、二-O-甲基高山異黃酮(di-O-methylalpinumisoflavone)、4'-甲基高山異
黃酮(4'-methyl-alpinumisoflavone)。富含異類黃酮類的植物來源包括但不限於大豆、補骨脂屬(psoralea)、葛藤、羽扇豆、蠶豆、鷹嘴豆、苜蓿草及花生。
在一實施態樣中,本發明之營養組成物包含有效量的膽鹼。有效量的膽鹼係介於每8fl.oz.(236.6mL)供應量約20mg膽鹼至每8fl.oz.(236.6mL)供應量約100mg之間。
該揭示之營養組成物可另外包含ß-葡聚糖來源。葡聚糖為多醣,特別為葡萄糖的聚合物,其為天然存在且可於細菌、酵母菌、真菌、及植物的細胞壁中發現。貝他(β)葡聚糖(β-葡聚糖)本身為多樣的葡萄糖聚合物次集合,是經由β類型糖苷鍵連接在一起以形成複合碳水化合物的葡萄糖單體鏈形成。
β-1,3-葡聚糖為例如從酵母菌、蕈類、細菌、藻類、或穀類所純化之碳水化合物聚合物。(Stone BA,Clarke AE.Chemistry and Biology of(1-3)-Beta-Glucans.London:Portland Press Ltd;1993.)β-1,3-葡聚糖的化學結構取決於β-1,3-葡聚糖來源。再者,各種物化參數,諸如溶解度、一級結構、分子量、及分枝,與β-1,3-葡聚糖生物活性有關。(Yadomae T.,Structure and biological activities of fungal beta-1,3-glucans.Yakugaku Zasshi.2000;120:413-431.)
β-1,3-葡聚糖係天然存在的多醣,其具有或不具有可見於各種植物、酵母菌、真菌及細菌的細胞壁中之
β-1,6-葡萄糖或β-1,4葡萄糖分支側鏈。
源自焙用酵母菌(釀酒酵母菌(Saccharomyces cerevisiae))的β-葡聚糖係藉由β醣苷鍵聯連接位置1及3之D-葡萄糖分子鏈組成,並具有藉由β醣苷鍵聯接附在位置1及6的葡萄糖側鏈。源自酵母菌之β-葡聚糖係不可溶、纖維狀的複糖,具有帶β-1,3骨架的葡萄糖單元直鏈的一般結構並散佈著通常為6-8個葡萄糖單元長的β-1,6側鏈。更特定言之,源自焙用酵母菌的β-葡聚糖係聚-(1,6)-β-D-葡萄哌喃糖苷基-(1,3)-β-D-葡萄哌喃糖。
又,β-葡聚糖耐受性佳且不會在小兒個體產生或造成過量氣體、腹部膨脹(abdominal distension)、氣脹(bloating)、或腹瀉。將β-葡聚糖加入供小兒個體之用的營養組成物(諸如嬰兒配方、成長乳、或其他孩童營養產品)將藉由增加對入侵病原體的抵抗力且因此維持或改善整體健康而改善個體的免疫反應。
本發明之營養組成物可包括β-葡聚糖。在一些實施態樣中,該β-葡聚糖係β-1,3;1,6-葡聚糖。在一些實施態樣中,該β-1,3;1,6-葡聚糖可源自焙用酵母菌。該營養組成物可包含全葡聚糖粒子β-葡聚糖、顆粒β-葡聚糖、微顆粒β-葡聚糖、PGG-葡聚糖(聚-1,6-β-D-葡萄哌喃糖苷基-1,3-β-D-葡萄哌喃糖)或彼等之任何混合物。在一些實施態樣中,微顆粒β-葡聚糖包含具有直徑小於2μm之β-葡聚糖粒子。
在一些實施態樣中,該β-葡聚糖存在於該組
成物中的量係在介於每100g的該營養組成物為約0.010及約0.080g之間。在其他實施態樣中,該營養組成物包含每供應量介於約10及約30mg之間的β-葡聚糖。在另一實施態樣中,該營養組成物包含每8fl.oz.(236.6mL)供應量介於約5及約30mg之間的β-葡聚糖。在其他實施態樣中,該營養組成物包含β-葡聚糖的量足以提供每日約15mg及約90mg之間的β-葡聚糖。在一些實施態樣中,該營養組成物可以多重劑量而投遞,以達到整日投遞至個體的標的量之β-葡聚糖。
在一些實施態樣中,該β-葡聚糖在該營養組成物中的量係介於每100kcal約3mg及約17mg之間。在另一實施態樣中,該β-葡聚糖的量係介於每100kcal約6mg及約17mg之間。
該營養組成物可直接導至個體的腸道。在一些實施態樣中,該營養組成物係直接導至腸中。在一些實施態樣中,該組成物可經調配以在醫師監督下經腸道食用或投與或且可意欲供諸如腹瀉疾病(celiac disease)及/或食物過敏之疾病或病況的特定膳食管理之用,該疾病或病況之不同營養需求,基於所認可之科學原理,藉由醫學評估而建立。
本發明之營養組成物不限於包含特別列於本文中之營養素的組成物。任何營養素可投遞作為該組成物一部分以供符合個體內營養需求和/或以便最佳化個體內營養狀態之目的。
本發明之營養組成物可經標準化至特定熱量含量,其可提供作為即用產品,或其可以濃縮形式提供。
在一些實施態樣中,本發明之營養組成物係成長乳。成長乳為針對超過1歲的孩童(典型上為1-3歲、4-6歲、或1-6歲)的經營養強化之以乳為底質的飲料。成長乳係經設計欲作為多樣性膳食的互補物,以提供孩童達到持續、每日攝入所有必需維生素及礦物質、巨量營養素和額外功能性膳食組分(諸如具有據信可促進健康性質非必需營養素)的額外保障。
根據本發明之營養組成物的精確組成可依市場而異,其取決於當地法規及所關注之族群的膳食攝入資訊。在一些實施態樣中,根據本發明之營養組成物包括諸如全乳或脫脂乳之乳蛋白來源,且外加糖及甜味劑以達到所欲之感官性質,以及外加維生素及礦物質。脂肪組成物典型上係源自乳原料。總蛋白質可為調整標的以符合人乳、牛乳、或較低值之總蛋白質。總碳水化合物係通常為調整標的以盡可能提供極少的外加糖(例如蔗糖或果糖),以達到可接受之口味。典型上,加入維生素A、鈣、及維生素D至符合地區性牛乳貢獻之營養素的量。抑或是,在一些實施態樣中,可加入維生素及礦物質至提供約膳食營養素參考攝取量(DRI)的20%或每份供應量的每日營養素攝取量基準值(DV)的20%之量。又,營養素值可依市場而異,取決於經確認之所關注族群的營養需求、原料貢獻及地區性法規。
在某些實施態樣中,該營養組成物係低致敏性。在其他實施態樣中,該營養組成物係符合猶太律法食物(kosher)。在又進一步之實施態樣中,該營養組成物係非基改產品。在一實施態樣中,該營養配方品係不含蔗糖。該營養組成物亦可不含乳糖。在其他實施態樣中,該營養組成物不含任何中鏈三酸甘油酯油。在一些實施態樣中,未有角叉菜膠存在於該組成物中。在其他實施態樣中,該營養組成物不含所有膠類。
因此,藉由實施本發明,製備具有迄今尚未認知的安定性的經安定化之益生菌。該經安定化之細菌混合物透過使用經水解之哺乳動物蛋白質、特別是經水解之哺乳動物蛋白質貝有超過70%的胜肽具有小於2,000道耳頓分子量,展現非常高的安定性。該經安定化之益生菌對具有中度濕分量(例如水活性高至0.4)而提升在熱且潮濕環境中保存期限及安定性壽命為所欲者之營養應用特別有效。該經安定化之益生菌可分開包裝或與任何本文中所述之營養組成物之實施態樣組合。
所有本說明書中所引用之參考文獻、包括但不限於所有論文、刊物、專利、專利申請、發表、文字、報導、文稿、小冊、書籍、網路文章、期刊文章、定期性刊物等等,在此係以引用方式將它們全部併入本說明書。本文中之參考文獻的討論僅欲用於總結該些參考文獻作者之主張,並未承認任何參考文獻構成先前技術。申請人保留挑戰引用之參考文獻之準確性和相關性的權利。
雖然已使用特定術語、裝置及方法說明本發明之較佳實施態樣,但此說明僅為描述目的之用。所使用文字為說明文字而非限制性文字。應了解,在未悖離於下列申請專利範圍所述之本發明精神及範疇下,本發明所屬技術領域中具有通常知識者可進行更改及變動。此外,應了解,各種實施態樣之樣態可全部或部分相互取代。舉例而言,雖然已例示用於製造依據該些方法所製成的市售無菌液體營養補充物的方法,但其他使用亦被涵蓋。因此,後附申請專利範圍之精神及範疇不應受限於本文中所含的較佳形式之描述。
Claims (16)
- 一種營養組成物,其包含:蛋白質來源;及經安定化於保護性基質(protective matrix)中之益生菌,該保護性基質包含a.至少一種磷脂質;及b.至少一種甘油酯。
- 如請求項1之組成物,其中該益生菌包含存活性微生物細胞。
- 如請求項2之組成物,其中該存活性微生物細胞包含鼠李糖乳酸桿菌(Lactobacillus rhamnosus)。
- 如請求項1之組成物,其中該基質另包含碳水化合物來源。
- 如請求項1之組成物,其中該基質另包含果膠。
- 如請求項1之組成物,其中該至少一種磷脂質包含卵磷脂。
- 如請求項1之組成物,其中該至少一種甘油酯包含單甘油酯、雙甘油酯或彼等之任何組合。
- 如請求項1之組成物,其中該營養組成物係粉末嬰兒配方。
- 如請求項1之組成物,其中該營養組成物另包含至少一種另外之脂質組分。
- 如請求項1之組成物,其中該營養組成物另包含非存活性益生菌。
- 一種用於保護供使用於粉末營養組成物的存活性益生菌之方法,該方法包含:a.提供存活性益生菌;b.藉由摻合下述成分而製備用於該益生菌之保護性基質:i.至少一種磷脂質;及ii.至少一種甘油酯;c.將該存活性益生菌、該保護性基質及水組合以製造混合物;及d.乾燥步驟(c)之混合物至約4%或更低之最終濕分含量。
- 如請求項11之方法,其包含將該步驟(d)之經乾燥之混合物加至粉末營養產品之另外步驟。
- 如請求項11之方法,其包含將該步驟(d)之經乾燥之混合物密封於膠囊中之另外步驟。
- 如請求項13之方法,其中該膠囊另包含二十二碳六烯酸之量。
- 如請求項11之方法,其中該存活性益生菌包含鼠李糖乳酸桿菌。
- 如請求項11之方法,其中該存活性益生菌包含長雙叉桿菌BB536(Bifidobacterium longum BB536)、長雙叉桿菌嬰兒亞種35624(Bifidobacterium longum subsp.infantis 35624)、動物雙叉桿菌乳酸亞種BB-12(Bifidobacterium animalis subsp.lactis BB-12)或彼等之任何組合。
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