TWI462740B - 奈米級類胡蘿蔔素環糊精複合物 - Google Patents
奈米級類胡蘿蔔素環糊精複合物 Download PDFInfo
- Publication number
- TWI462740B TWI462740B TW095137067A TW95137067A TWI462740B TW I462740 B TWI462740 B TW I462740B TW 095137067 A TW095137067 A TW 095137067A TW 95137067 A TW95137067 A TW 95137067A TW I462740 B TWI462740 B TW I462740B
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- TW
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- Prior art keywords
- cyclodextrin
- carotenoid
- final blend
- water
- fish oil
- Prior art date
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Description
本申請案主張於2005年10月5日提申之美國臨時申請案第60/724,051號之利益。
本發明係相關於提高由含有類胡蘿蔔素之營養調配物所提供之類胡蘿蔔的生物利用度的組成物及相關方法。因此,本發明涉及化學、食品科學、生物學及營養學領域。
類胡蘿蔔素係一種具高度有色的油溶性植物色素,其營養與健康上的優點已為眾所周知。類胡蘿蔔素之相關優點包含抗氧化活性和可轉化成維生素A。研究指出在飲食攝取較高的類胡蘿蔔素,可提供保護以對抗某些癌症、黃斑部病變、白內障、心臟疾病及其他與抗氧化或自由基損害相關之健康狀態的發展。由於與類胡蘿蔔素相關的顯著且合意的健康利益,營養公司已迅速在市場上銷售含有類胡蘿蔔素的產品。遺憾的是,類胡蘿蔔素不能立即溶解於腸液中,因此身體對其之吸收通常是相當低的。
因此,持續在尋找改善類胡蘿蔔素及其他營養素之吸收與生物利用度的方法與系統。
因此,本發明係提供增進營養素,特別是類胡蘿蔔素的生物利用度的方法及組成物,其主要是經由特殊之製造技術。
本發明的一具體實例中,包含一種製造含有類胡蘿蔔素之營養補充品的方法。該方法包含在50℃時將一定量的環糊精與水混合以形成一水/環糊精漿狀物;將一定量之至少一種的類胡蘿蔔素與該水/環糊精漿狀物摻合,以形成含有環糊精類胡蘿蔔素複合物的預摻合組成物;對該預摻合組成物抽真空且徹底混合該預摻合組成物最少1小時;在真空下使該未乾燥之預摻合組成物與額外的營養成分在約40℃至約45℃的溫度下混合以形成一最終摻合物;在真空下研磨該最終摻合物;將該經研磨的最終摻合物裝入膠囊內。
在本發明的一方面,該環糊精係為一γ-環糊精。在本發明的另一方面,該至少一種類胡蘿蔔素係選自由還原蝦紅素(astaxanthin)、番茄紅素(lycopene)、玉米黃素(zeaxanthin)、β-胡蘿蔔素及其組合所組成之族群。在本發明的另一方面,可將額外的營養成分併入組成物中,包含魚油、蜜蠟、維生素A、維生素E、葉黃素(lutein)、磷蝦油(krill oil)及其組合。
在本發明的另一具體實例,為一製造含有類胡蘿蔔素的營養補充品,包含在一摻合裝置中加熱一定量的水至50℃;使一定量的環糊精與水混合以形成水/環糊精漿狀物;將一定量的至少一種類胡蘿蔔素與該水/環糊精漿狀物掺合以形成一含有環糊精類胡蘿蔔素複合物的預摻合組成物;將該預摻合組成物抽真空並在一單獨的混合容器內徹底混合該預摻合組成物最少1小時;經由在60℃下混合一定量的魚油直至徹底混合,而後冷卻至40-45℃以形成魚油摻合物;在真空下將未乾燥的預摻合組成物與魚油/蜂蠟摻合物於約40-45℃的溫度混合以形成最終摻合物;視需要掺合額外的營養成分至最終摻合物內,冷卻最終摻合混合物至25-28℃;在真空下將最終摻合物研磨以降低顆粒大小;將該經研磨的最終摻合物裝入膠囊內。
在描述及主張本發明時,下列名詞係依據下述定義使用。
除非文中另有明確指示,該單數型態”一”及”該”係包含複數型態之所指對象。因此,舉例而言,含有”一種環糊精成分”之營養補充品指的是包含一或多種環糊精成分,而所指”該類胡蘿蔔素”包含指的是一或多種類胡蘿蔔素。
在此所使用的”個體(subject)”係指哺乳動物,其可自所給予之本發明營養補充品或方法獲得益處。個體之例子包含人類,及也可包含其他動物,例如馬、豬、牛、狗、貓、兔子及水生哺乳動物。
在此所使用的”調配物”及”組成物”可交替使用,且係指二或多種化合物、元素或分子的混合物。
在此所使用的,”單一劑量”係指一或多種膠囊傳遞單位,其可將欲量的類胡蘿蔔素傳遞給一個體。
在此所使用的”有效量”及”足夠量”可交替使用,且係指一成分的一定量,當其被包含在一咀嚼組成物中時,足以達到一預期的組合或生理效果。舉例而言,”足夠量”的類胡蘿蔔素抽出物係為要具有營養效果所需的最小數量。另外,”治療有效量”係指足以達到所欲生理效果的類胡蘿蔔素的量。有效量的決定為製藥、營養食品、製草藥、化妝品及醫藥科學技術領域中的一般技藝人士所熟知的。舉例而言,參見Meiner及Tonascia所著之”Clinical Trails:Design,Conduct,and Analysis,”Monographs in Epidemiology and Biostatics,
Vol.8(1986),其全文係以參考方式併入本文。
“掺合”一詞係指該藥物及/或增強劑能被溶解、分散或懸浮於載體中。在某些實例中,該藥物可被均勻地掺合於載體中。
在此所使用的複數物件、結構元件、組成元件及/或物質,為了方便起見可以一共同表單呈現。然而,這些表單應被解讀為如同該表單中的各個成員係被單獨確認為個別且獨特的成員。因此,在沒有相反的指示下,該表單中沒有一個個別成員應被解讀為事實上等同於同一表單中的任一其他的成員,僅僅基於他們出現在一共同的組群中。
濃度、數量及其他數字資料得以範圍形式陳述或表示。可以理解的是,該範圍形式係僅為方便及簡潔而使用,因此應彈性解釋為不僅包含已明確列舉作為範圍界限的數值,而且也包含所有涵括於該範圍內的所有個別數值或次範圍,猶如每個數值及次範圍已明確列舉。作為一個實例,”約1至約5”的數值範圍應被解釋為不僅包含所明確列舉的約1至約5的數值,而且也包含所指範圍內的個別數值及次範圍。因此,包含在此數值範圍的有例如2、3及4的個別數值及例如自1至3、自2至4及自3至5等的次範圍。
此相同原則應適用僅列舉單一數值的範圍。更進一步,不論範圍的廣度或所描述特性,這樣的解釋均應適用。
本發明包含一種製備含有類胡蘿蔔素的營養補充品的方法,包含形成一種類胡蘿蔔素-環糊精複合物。類胡蘿蔔素在營養領域係眾所周知可提供多種健康益處。本發明提供製造一種可快速地被吸收之含有類胡蘿蔔素的營養補充品之方法,其係操作簡單,具時間與成本效率,且製成產品中的類胡蘿蔔素兼具高穩定性及為快速生物可利用的。
在營養補充品技藝眾所周知的是,類胡蘿蔔素在腸液中具低溶解度。此低溶解度造成類胡蘿蔔素進入系統循環的低吸收率或攝取率。另一造成類胡蘿蔔素低吸收率的因素為類胡蘿蔔素有聚集成不易快速消化或吸收的大粒子的傾向。環糊精能囊包(encapsulate)該低溶解性化合物以增加其溶解度並抑制一般會發生的聚集。該較小的囊包化合物通常指奈米顆粒,因為其非常小的顆粒大小。
本發明提供一種有效率的方法以製造含有類胡蘿蔔素-環糊精複合物的營養補充品。特別是,該方法提供了類胡蘿蔔素-環糊精複合物的生產及隨後將其直接併入營養補充品(而沒有中間的收集、分離及乾燥步驟)。因為類胡蘿蔔素-環糊精複合物可直接併入營養補充品中而沒有中間的步驟,所以降低了成本。
本發明之方法包含藉由結合一定量的環糊精與水以產生一環糊精漿狀物。製造該漿狀物的較佳溫度是從至50℃。所有類型的環糊精及其組合均得使用於本發明中,包含α-環糊精、γ-環糊精及β-環糊精。在一具體實例中,所使用的環糊精為γ-環糊精。在另一具體實例中,該環糊精為γ-環糊精與β-環糊精的混合物。該環糊精與水的混合物應被混合約20分鐘的一段時間或直至觀察到褐色的顏色。水的角色是用於水合環糊精。水合的環糊精可更佳地與類胡蘿蔔素複合。一旦形成該環糊精漿狀物,可將類胡蘿蔔素摻合於其中。該類胡蘿蔔素/環糊精混合物的混合應在溫度自約40℃至約50℃持續最少1小時。在高剪切力下混合類胡蘿蔔素/環糊精混合物,可增強或增加反應速率,及類胡蘿蔔素-環糊精複合物的形成速率。然而,較低的混合速率所產生的較低剪切值,同樣可有效地使用於形成該類胡蘿蔔素-環糊精複合物。
在本發明中可使用的類胡蘿蔔素,包含任何在所屬領域中已知具有正向健康益處的類胡蘿蔔素。用於本發明之較佳的類胡蘿蔔為還原蝦紅素、番茄紅素、玉米黃素、β-胡蘿蔔素、葉黃素及其混合物。若是可行,較佳應對本發明之含有類胡蘿蔔素的組成物抽真空,以減緩或抑制該類胡蘿蔔素的降解。另一維持類胡蘿蔔素的穩定性之可接受的方法,係將含有類胡蘿蔔素的混合物存放在氮氣下。
當混合該類胡蘿蔔素/環糊精組成物時,類胡蘿蔔素-環糊精複合物開始自溶液沉澱而使溶液更為黏稠。此黏稠度的增加可作為成功形成類胡蘿蔔素-環糊精複合物的指標。在傳統的類胡蘿蔔素-環糊精複合物製造方法中,該沉澱的複合物係在製程的此刻被收集、分離及乾燥。藉此,將原本存在於環糊精漿狀物中的水分排除。在本發明的方法中,該複合物係維持在含有水的預摻合漿狀物中。本發明的製造方法能省略乾燥方法的能力,降低了與製程相關的時間及成本。
在該類胡蘿蔔素-環糊精複合物形成之後,然後可在40℃至45℃的溫度將該預摻合漿狀物與額外的營養成分混合以形成一最終摻合物。將該最終摻合物徹底混合最少20分鐘。在本發明中可使用之額外的營養成分的例子包含但不限於,維生素A、維生素E、葉黃素、魚油、檸檬烯(limonene)、蜂蠟及其組合。較佳的是,該最終摻合物係與魚油混合。熟習此項技藝人士所熟知之任何種類的魚油均可於本發明中使用。就本發明之目的而言,亦包含磷蝦油作為魚油。
除了魚油所固有的健康益處之外,添加魚油至預摻合物漿狀物中有助於穩定及溶解任何存在於該預摻合漿狀物中之未複合的類胡蘿蔔素,進而增強該複合及未複合之類胡蘿蔔素兩者的生物利用度。經確定的是,當本發明的類胡蘿蔔素-環糊精複合物與一最小量的魚油共同投予時,該類胡蘿蔔素的生物利用度被提高而優於單獨投予該類胡蘿蔔素-環糊精複合物時。不受理論的限制,咸信此生物利用度的增加是因為,至少部分是因為,魚油對腸內脂肪酶的刺激,因而促進類胡蘿蔔素的吸收。在一較佳具體實例中,該魚油構成最終摻合組成物的約70重量%至約90重量%。在另一具體實例中,該魚油構成最終摻合組成物的約75重量%至約85重量%。當其他的營養成分,特別是可快速氧化的成分如維生素A及維生素E被包含在最終摻合組成物中時,魚油也作用於穩定及保護那些成分。
一旦完成該最終摻合組成物,則將其研磨以確保該複合類胡蘿蔔素之小顆粒大小。在研磨之後,可將該最終摻合物直接裝入膠囊或儲存於氮氣的氣密容器中。在本發明的較佳具體實例中,該最終摻合物係被囊包於軟明膠膠囊中。本發明方法所生產的組成物係意欲傳遞給個體,以提供該個體治療有效量的類胡蘿蔔素。該劑量可由一般習於此項技藝人士,基於本發明組成物中類胡蘿蔔素的濃度而快速決定。
除方法外,本發明提供一種增強類胡蘿蔔素生物利用度的組成物及相關之方法。具體而言,頃發現當前述之該最終摻合組成物包含魚油時,類胡蘿蔔素的生物利用度令人意想不到地被提高,而優於單獨只有類胡蘿蔔素/環糊精複合物及單獨只有魚油/類胡蘿蔔素混合物的生物利用度。如同前述,咸信該令人意想不到的生物利用度的提高是因為,至少部分是因為,魚油對腸內脂肪酶的刺激,因而促進該類胡蘿蔔素的吸收。
下列所提供的實施例,僅為製造本發明含有類胡蘿蔔素之營養補充品的一具體實例的例示說明。雖然該處理條件及成分可為較佳的,但不意味對其設限。
一種穩定的含有類胡蘿蔔素之營養補充品,係依下列步驟製備:1.將5.640公斤的水加入混合機中,並加熱至50℃,於加入環糊精前先確認溫度。
2.自混合機容器中移除混合機的葉片,及加入4.070公斤的γ-環糊精(Cavamax V Wacker Biochem),並先以手混合,而後以機械混合至少30分鐘或直至一環糊***漿狀物形成。該漿狀物為褐色。
3.加入表列數量的下列類胡蘿蔔素:
4.對混合容器抽真空,並將該組成物在4-45℃的溫度下低速(9.6 rpm)混合至少1小時,並形成類胡蘿蔔素環糊精複合物。(注意:當類胡蘿蔔素與環糊精反應時,化合物會沉澱,且混合物的黏度會增加,其為成功的複合反應的指標)。
5.在至少1小時的混合後,立刻移出含有該類胡蘿蔔素-環糊精複合物的混合機容器,並加到一含有魚油蜂蠟摻合物的主要混合機內。該魚油與蜂蠟摻合物係藉由加入大約6.1公斤的蜂蠟及73.2公斤的魚油至混合機中,並於60℃摻合直至完全混合而製造。然後在該類胡蘿蔔素-環糊精複合物加入之前,將該組成物冷卻至40-45℃。使用小量的魚油/蜂蠟組成物將類胡蘿蔔素-環糊精複合物沖到混合機容器中。
6.然後可將額外的成分加到該混合機中。該等成分及添加量顯示於下表:
7.在加入該類胡蘿蔔素/環糊精複合物及其他成分後,將在該混合機內的混合物抽真空,並在20-45℃下以高剪切力混合該混合物20分鐘。而後使該混合物冷卻至25-28℃並自混合機移出及研磨以降低顆粒大小。
8.經研磨後,將該混合物儲存在一含氮密封容器內或立即裝入膠囊內。裝入膠囊可在軟明膠膠囊中完成。每一軟明膠膠囊含有約1.2公克經研磨的最終組成物。
進行研究以測定申請專利範圍第1項之組成物於個體皮膚類胡蘿蔔素評分(Skin Carotenoid Scores;SCS)的效果。該研究涉及利用拉曼光譜法(Raman Spectroscopy)評估,相較於安慰劑,補充有實施例1的組成物在18週期間內皮膚類胡蘿蔔素得分的變化。
52位年齡介於18至65歲之個體具資格參與本研究。使用進食頻率及健康史問卷篩選內含標準,並利用華茂生物光子掃描儀(Pharmanex Biophotonic scanner)評估皮膚類胡蘿蔔素之水平。攝取抗氧化劑補充品、具高度陽光暴露量或使用曬黑床(tanning bed)、懷孕婦女之個體,或使用免日晒型晒黑產品之個體,係被排除在本研究外。所有個體皆為健康非吸煙者,並接受含有少於5份每日水果及蔬菜之典型美國飲食,且具有拉曼強度得分基礎線介於13,000和35,000之間的拉曼強度計數(Raman Intensity Counts)。參與者被告知在整個研究期間維持其飲食及運動習慣。符合本研究標準的個體(n=52)隨機以雙盲方式分到二組中的一組,分別為實施例1之組成物組(n=27)或安慰劑組(n=25)。
給予個體其各自的膠囊,安慰劑或實施例1之組成物,並指示個體一天服用兩次(一次與早餐一起,一次與晚餐一起)。實例1參與者之劑量包含每天二次,每次二個軟膠囊。每天服用兩次的安慰劑亦包含二個軟膠囊,其含有ω-3脂肪酸但不含類胡蘿蔔素。
研究結果顯示該皮膚類胡蘿蔔素評分令人意想不到地高度的提高。具體而言,相較於幾乎沒有改變的安慰劑組參與者,服用實施例1之組成物者,在18週後平均增加了17,757拉曼強度計數。在整個18週的研究期間,類胡蘿蔔素光電子掃描評分(Carotenoid Scanner Score)持續增加,而未有明顯的高原效應。
上述實施例係以一或更多的特定應用說明本發明的原則,對於一般習於此項技術者而言,可對形式、用法及實施的細節作各種修飾而不運用創新技能,亦不偏離本發明的原則與概念是非常明顯的。因此,除了如以下所列之申請專利範圍外,其並非意欲限制本發明。
Claims (13)
- 一種製造含有類胡蘿蔔素之營養補充品的方法,其包括(a)在50℃將一定量的環糊精與水混合,以形成水/環糊精漿狀物;(b)將一定量之至少一種類胡蘿蔔素摻合至該水/環糊精漿狀物,以形成包含環糊精類胡蘿蔔素複合物的預摻合組成物;(c)對該預摻合組成物抽真空,且徹底混合該預摻合組成物最少1小時;(d)藉由在真空下將未乾燥之預摻合組成物與包括魚油的額外的營養成分在約40℃至45℃的溫度下混合,以形成最終摻合物;(e)在真空下研磨該最終摻合物;(f)將該經研磨的最終摻合物裝入膠囊內。
- 如申請專利範圍第1項之方法,其中該環糊精為γ-環糊精。
- 如申請專利範圍第1項之方法,其中該環糊精為γ-環糊精與β-環糊精之組合。
- 如申請專利範圍第1項之方法,其中該至少一種類胡蘿蔔素係選自由還原蝦紅素、番茄紅素、玉米黃素、β-胡蘿蔔素、葉黃素及其混合物所組成之族群。
- 如申請專利範圍第1項之方法,其中該額外的營養成分進一步包括選自由蜂蠟、維生素A、維生素E、D-檸檬烯 及其混合物所組成之族群的成員。
- 如申請專利範圍第1項之方法,其中該魚油係構成該最終摻合物的70重量%至90重量%。
- 如申請專利範圍第6項之方法,其中該魚油係構成該最終摻合物的75重量%至85重量%。
- 如申請專利範圍第1項之方法,其中該經研磨的最終摻合物係裝入軟明膠膠囊內。
- 如申請專利範圍第1項之方法,其中(a)是藉由在摻合裝置中加熱一定量的水至50℃來進行,並且之後將一定量的環糊精與水混合以形成水/環糊精漿狀物;其中(d)中的額外的營養成分包括在(d)之前在分開的混合容器中被加熱至溫度40℃至45℃的魚油;且其中在(d)之後及(e)之前,該方法進一步包含視需要地將額外的營養成分摻合至該最終摻合物中且之後將該最終摻合物冷卻至25℃至28℃。
- 如申請專利範圍第9項之方法,其中該環糊精為γ-環糊精。
- 如申請專利範圍第9項之方法,其中該環糊精為γ-環糊精與β-環糊精之組合。
- 如申請專利範圍第9項之方法,其中該至少一種類胡蘿蔔素係選自由還原蝦紅素、番茄紅素、玉米黃素、β-胡蘿蔔素、葉黃素及其混合物所組成之族群。
- 如申請專利範圍第9項之方法,其中該額外的營養成分係選自由蜂蠟、維生素A、維生素E、D-檸檬烯及其混 合物所組成之族群。
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AU2003242589A1 (en) * | 2002-05-30 | 2003-12-19 | Phares Pharmaceutical Research N.V. | Oil-soluble pigment compositions |
WO2004005353A1 (en) | 2002-07-04 | 2004-01-15 | Poltec As | Complexes of cyclodextrins and carotenoids |
WO2005075613A1 (en) * | 2004-02-06 | 2005-08-18 | Adrien Beaudoin | Method for preventing the oxidation of lipids in animal and vegetable oils and compositions produced by the method thereof |
AU2004316985A1 (en) | 2004-02-23 | 2005-09-15 | The Texas A & M University System | Antioxidant compositions and methods of use thereof |
US8067045B2 (en) * | 2005-03-03 | 2011-11-29 | Pharmanex, Llc | Nutritional formulations and associated methods |
US7781572B2 (en) * | 2005-10-05 | 2010-08-24 | Nse Products, Inc. | Nanosized carotenoid cyclodextrin complexes |
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2006
- 2006-10-04 US US11/538,766 patent/US7781572B2/en active Active
- 2006-10-05 KR KR1020087008961A patent/KR101255874B1/ko active IP Right Grant
- 2006-10-05 TW TW103125072A patent/TWI514970B/zh active
- 2006-10-05 CN CN2006800372474A patent/CN101505596B/zh active Active
- 2006-10-05 WO PCT/US2006/039383 patent/WO2007044659A2/en active Application Filing
- 2006-10-05 EP EP06836231A patent/EP1931361A4/en not_active Withdrawn
- 2006-10-05 JP JP2008534755A patent/JP5106402B2/ja active Active
- 2006-10-05 TW TW095137067A patent/TWI462740B/zh active
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2010
- 2010-05-20 US US12/784,387 patent/US20110129562A1/en not_active Abandoned
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2016
- 2016-03-01 US US15/058,046 patent/US20170021035A1/en not_active Abandoned
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2018
- 2018-04-16 US US15/954,464 patent/US20190111020A1/en not_active Abandoned
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2021
- 2021-03-29 US US17/216,506 patent/US20210322371A1/en active Pending
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
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WO2003053475A1 (en) * | 2001-12-21 | 2003-07-03 | Chiesi Farmaceutici S.P.A. | Process for preparation of inclusion compounds between a non-steroidal anti-inflammatory drug and betacyclodextrin by microwave treatment |
US20040109920A1 (en) * | 2002-12-04 | 2004-06-10 | Bioactives Llc | Coated carotenoid cyclodextrin complexes |
Also Published As
Publication number | Publication date |
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US20110129562A1 (en) | 2011-06-02 |
US20170021035A1 (en) | 2017-01-26 |
KR20080055920A (ko) | 2008-06-19 |
US20210322371A1 (en) | 2021-10-21 |
TW201440665A (zh) | 2014-11-01 |
TW200800229A (en) | 2008-01-01 |
US20070191307A1 (en) | 2007-08-16 |
US20190111020A1 (en) | 2019-04-18 |
JP2009524576A (ja) | 2009-07-02 |
CN101505596B (zh) | 2012-07-18 |
CN101505596A (zh) | 2009-08-12 |
TWI514970B (zh) | 2016-01-01 |
US7781572B2 (en) | 2010-08-24 |
EP1931361A4 (en) | 2012-01-25 |
WO2007044659A3 (en) | 2009-04-30 |
WO2007044659A2 (en) | 2007-04-19 |
EP1931361A2 (en) | 2008-06-18 |
KR101255874B1 (ko) | 2013-04-17 |
JP5106402B2 (ja) | 2012-12-26 |
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