TWI429445B - 以植物纖維為主之醫用營養補充及膳食營養組成物 - Google Patents
以植物纖維為主之醫用營養補充及膳食營養組成物 Download PDFInfo
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Classifications
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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
- A23L33/20—Reducing nutritive value; Dietetic products with reduced nutritive value
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- A—HUMAN NECESSITIES
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Description
本發明係關於醫用營養補充及膳食營養組成物，其包含：a)葡甘露聚糖，b)梨果仙人掌(Opuntia ficus indica
)，c)微晶纖維素。
此等組成物於胃腸部分呈現高潤脹指數，其產生立即的飽足感，釋放縮膽囊素，及減緩胃排空而延長飽足感。使三種植物纖維之複合物與冷凍乾燥膠漿之混合物結合可提高其於胃腸部位的潤脹性質。
膳食纖維被定義為「不可被人類消化器官分泌之酵素水解，僅可被腸內菌屬部分水解，且被歸類為以下類別之植物來源的物質：纖維素、改質纖維素、半纖維素、果膠、植物膠、膠漿及木質素」。鑑於其之「難消化性」，由於人類消化器官之酵素無法分解多醣鏈以成為可被身體消化吸收的較簡單成分(單醣)，因而纖維實質上不具有營養或能量價值，但在其通過消化道之過程中進行一系列對正常腸道功能重要且對一般的全身健康相當有用的功能及代謝作用。
因此，熟知膳食纖維為飲食的基本成分，且許多流行病學研究顯示飲食富含植物纖維的族群較飲食特徵為低膳食纖維含量的族群不易罹患便秘、許多其他消化器官的常見病症(結腸炎、胃腸脹氣、憩室炎等等)及代謝障礙(肥胖、血脂異常及糖尿病)。經常結合富含蔬菜、穀物及水果之飲食攝入膳食纖維，亦可降低消化器官腫瘤(尤其係大腸直腸癌)的風險。
膳食纖維係由透過α及β醣苷鍵聚合之長多醣鏈構成之極度複雜的植物化合物組合所組成，其差異在於將其結合之醣苷鍵的類型、鏈的長度、重複醣單元之類型及分支程度。
膳食纖維的各種成分可根據其於水中之行為而分類為：．可溶性纖維：主要為特徵在於高溶解度及或多或少顯著之形成黏性、凝膠狀溶液之能力的多醣。
．不可溶性纖維：其當與水接觸時不會大大地改變其結構，雖然其可藉由提高其質量而維持大部分的結構；其主要係作為潤脹劑，而產生一般稱為「墊底效應(ballast effect)」的效應。
當置於水或水溶液中時，可溶性纖維有在多醣鏈的各個鏈段之間建立「接觸點」的傾向，而形成類似一種「天然膠」的三維組織結構，其係高度黏性及吸收性，且其滯留甚多周圍的液相及任何溶解於其中的溶質。可溶性纖維於體重控制中的效用係基於其當水合時，形成結合及滯留一定比例之經攝取食物(尤其係糖及脂肪)之濃稠、大量天然膠的能力，其接著在消化完畢時隨排泄物排除(與纖維一起)，而不會以任何方式提高膳食的卡洛里含量。
此降低食物吸收的能力係透過兩種不同、互補的機構發生：第一種機構係取決於膠的「機械」作用(其藉由吸附而將液體及溶解營養物捕捉於其晶格中)，同時第二種機構係基於纖維提高消化內容物之黏度及因此減緩營養物被小腸絨毛吸收之速率，而阻礙擴散程序及降低營養物之吸收的能力。攝取纖維的另一結果為降低經消化物質經過腸的時間(經消化物質由於由纖維所形成之天然膠而更快速地「滑動」)，吸收時間亦因此降低。
除了降低食物吸收外，纖維不僅由於由纖維於胃腸道內潤脹所造成之體積增加，並且尤其由於對腸內容物之黏度控制效應，其減緩葡萄糖消化吸收程序，以致餐後葡萄糖高峰更緩慢地出現及消失，而產生延長的飽足感。
基於前述的所有理由，膳食纖維被廣泛地使用作為低卡洛里飲食中的輔助品及作為纖維補充品。目前市場上基於膳食纖維的產品包括CM3－一種基於高度交聯纖維素的醫療設備；Normaline Herbs－基於葡甘露聚糖及纖維素；Forlip－基於梨果仙人掌、聚葡萄胺糖及纖維素；及Dicoplus 100－基於葡甘露聚糖。美國市面上亦銷售一種稱為SyndRx的產品，其含有葡甘露聚糖及梨果仙人掌，且經指示供血糖控制用。
多醣的生理性質部分可基於化學物理性質諸如發酵作用、保水力、黏度、及對膽汁酸之結合而預測。
WBC(水結合容量)：此係當系統受到物理應力諸如離心作用時不會釋放的水量。其係會受膠之pH、離子強度及微結構影響的參數。
WHC(保水容量)：定義為當系統未受到物理應力時所捕捉於晶格中的水量，其與存在於系統中之水分直接相關。
吸收及吸附有機物質之能力：一些可溶性纖維於其基質中捕捉凝膠狀有機分子諸如膽汁酸、甾醇、毒性化合物及其他自人體移除之廢物的能力。
離子交換容量：纖維由於存在於醣殘基中之大量的游離羧基及多醣之糖醛酸含量而作為弱離子交換樹脂。
凝膠形成：置於水中之可溶性纖維產生特徵在於可維持液相之三維固態巨分子晶格的黏性凝膠狀結構。
溶解度及黏度：大部分的多醣係以不規則的螺旋或「糾結」存在於溶液中，其於達到臨界濃度後，分散於液體中並與相鄰分子交互作用，而產生實質的流動阻力。黏度會伴隨延長的胃排空及增加的經過小腸。較慢的胃排空可能係由於各種因素，諸如於胃環境中之增加體積的高黏度多醣，其導致胃壁膨脹所致。此膨脹產生縮膽囊素(CCK)的增加釋放，其依序減緩胃排空。此外，CCK之增加釋放可能與當攝取高黏度多醣時之脂肪的降低吸收及消化有關。
WHC及WBC係指纖維當置於水性介質中時潤脹及在靜態或動態條件下將水分滯留於其基質中的能力。高黏度多醣通常具有高WHC/WBC值；於小腸中，其使腸內容物的總體積，尤其係水相的體積增加，因而稀釋吸收自水相之營養物的濃度，及減緩吸收速率。小腸中之水相的膨脹亦可有助於減緩脂質的吸收速率，該脂質不可溶於水相中而係形成使其可輸送通過此相至細胞表面的膠微粒。
高的WHC/WBC值可使水溶性或親水性物質滲透至纖維基質中，降低其於細胞表面的擴散，且因此有助於降低營養物的可吸收性。在大腸中，此現象使微生物可滲透至纖維基質中，及因此而提供更多使微生物可消化多醣的通道(益菌助生效應(prebiotic effect))。
雖然WHC可較捕捉於系統中之水量代表更真實的值，但該值的測定仍存在物理限制。事實上，樣品必需達到平衡條件，該條件必需對各單一原料定義及標準化，且其當相同原料之尺寸分佈變化時會有不同。基於此等理由，將WBC使用作為纖維特徵化參數。由於當系統高於飽和極限時，平衡條件係藉由於系統中插入過量溶劑而達成，因而WBC係與時間無關。有各種因素會影響纖維的WBC：與溶質的交互作用、毛細吸力及表面交互作用力。
存在計算WBC的不同方法：包曼(Baumann)裝置、吸收等溫線、及離心法。其各係透過其個自的吸水機構操作。包曼測定係以結合纖維之潤脹透過毛細力之作用吸收水為基礎。吸水等溫線係以蒸氣吸收為基礎。利用離心測定反映先由纖維吸收水(其可允許潤脹)，及接著再對纖維－水系統施加離心力的結合效應。離心法可被視為係用於計算包含於具高水活性(Aw>0.98)之系統(如於錠劑崩解後在胃環境中產生分散的情況)中之原料之WBC的最佳選擇。事實上，所考慮之原料經水「飽和」，且離心試驗可被比擬為達成該「飽和」狀態的加速方式。
現經發現包含下列成分之醫用營養補充及膳食營養組成物：a)葡甘露聚糖，b)梨果仙人掌，c)微晶纖維素，呈現高的胃腸潤脹指數，其會誘發立即的飽足感，釋放縮膽囊素，及減緩胃排空而延長飽足感。
經發現將冷凍乾燥膠漿之混合物添加至根據本發明之組成物可提高其之胃腸潤脹性質。
梨果仙人掌(Opuntia ficus indica
)或胭脂仙人掌(Nopal)係一種源自美洲熱帶區的仙人掌。其之活性成分包含在葉狀莖中，且係由黏液物質、纖維、蛋白質及礦物鹽所構成。在傳統的墨西哥藥物中，使用以梨果仙人掌葉為主成分的製劑來治療糖尿病。近年來，許多研究證實其有降血糖活性、對其他代謝障礙諸如肥胖及高血脂症的有利作用、飽足效應、及抗發炎、消化及止痛性質。活性成分係由取自至少四歲大植物之經脫水葉狀莖的葉肉所構成；於除去尖刺後，將葉狀莖切成薄片，完全乾燥，並最終剁碎至所需的微粒程度。經乾燥產物呈現為微細的淺綠色粉末。其係完全天然的原料，由於其之高膳食纖維含量，其可有利於飲食的整體平衡。
葡甘露聚糖係以藉由β 1－4鍵彼此結合之D－葡萄糖及D－甘露糖殘基為主之水膠體多醣所組成的可溶性膳食纖維。葡甘露聚糖係經由研磨蒟蒻(Amorphophallus konjac
)之塊莖而得，蒟弱係一種僅成長於特定區域諸如中國及日本的物種，其傳統上被使用作為食品。
纖維素係不可溶性纖維的來源，其得自纖維素漿在酸性環境中之水解。其係由透過β 1－4鍵結合之葡萄糖分子的線型聚合物所組成，其不會被腸的醯胺水解酶所侵蝕。其係高度不可溶解，且呈現為穀糠的主成分。
膠漿係屬於可溶性纖維之群，在此情況其係源自亞麻科(亞麻(Linum usitatissimum
))物種的可食用種子及錦葵科(Malvaceae)(藥蜀葵)及田麻科(Tiliaceae)(萊姆)之根、葉及花。經由水性萃取活性成分接著再冷凍乾燥而製得之冷凍乾燥萃取物尤其富含可溶性纖維，特別係膠漿。
更特定言之，本發明相關之醫用營養補充及膳食營養組成物包含在下列濃度範圍內的各種成分：a)在30及70%之間之來自蒟蒻的葡甘露聚糖；b)在10及50%之間之梨果仙人掌；c)在20及50%之間之微晶纖維素。
根據一較佳態樣，梨果仙人掌係以經脫水莖漿的形態存在。
根據一較佳態樣，根據本發明之組成物將亦包含濃度範圍在1及10%之間的膠漿混合物。
根據一較佳態樣，膠漿之混合物係由源自亞麻種子(亞麻)、藥蜀葵根(黃蜀葵(Althea officinalis
))及萊姆花(菩提花(Tilia platyphyllos
))的冷凍乾燥膠漿所構成。
根據本發明之組成物的各種成分呈現以下的特徵：－葡甘露聚糖可水合及潤脹，而形成在酸性環境中穩定的高度黏性凝膠狀水溶液。增加的黏度會影響胃排空時間，而導致延長的飽足感。
－纖維素會產生「墊底效應」，其伴隨增加重量的排泄物，增加的腸通過速率，增加的腔內結腸壓力及保持陷入於纖維晶格內之脂肪球及膽汁鹽的降低吸收。
－梨果仙人掌包含可提高其於酸性環境中之黏度的可溶性纖維(尤其係果膠)，及不可溶性纖維(尤其係纖維素和半纖維素)。
－亞麻、萊姆及藥蜀葵膠漿亦可水合及形成類似的凝膠系統。
在酸性環境中，梨果仙人掌形成甚大於其在中性pH下所傾向生成者的纖維材料晶格。此晶格的膨脹亦在結構上牽涉葡甘露聚糖、膠漿及纖維素纖維，而使表面增加及因此使各成分的水結合部位增加，而導致在WBC方面的增效作用。獲得被纖維之複合物所佔據體積及所滯留水分的增加。
因此，根據本發明之組成物由於在組成物之成分之間的增效作用，而在潤脹指數及WBC方面呈現較於個別投與結合之個別成分之後所得效應之總和大的效應。
當各種成分係以下列比例存在時，得到潤脹指數較個別成分之貢獻之總和多150%及WBC多140%之尤其重要的增效作用：a)來自蒟蒻的葡甘露聚糖 40±5% b)梨果仙人掌之經脫水莖漿 27±5% c)微晶纖維素 30±5% d)膠漿之混合物 3±2%
因此，根據一特佳態樣，根據本發明之組成物將包含比例如上所指的各種成分。
提供超越僅可由個別成分之總和而得之WBC及潤脹指數值之根據本發明之組成物產生較大尺寸的黏性凝膠化系統，其係纖維對胃腸系統之有利作用的原因。由於胃的膨脹，潤脹效應產生飽足感的立即增加(由於直接刺激迷走神經所致)及釋放縮膽囊素(由胃及小腸上部所分泌的局部荷爾蒙)，其減緩胃排空並延長飽足感。纖維的水結合容量(WBC)亦使腸內容物的體積增加，其減緩營養物的吸收速率。因此，在正餐之前數分鐘攝取根據本發明之組成物有助於降低/減弱胃中的飢餓感，及導致食物於腸中的較低吸收。
根據本發明之組成物可經適當地調配成經口投與，且其將係根據醫藥技術中熟知之習知方法，諸如說明於美國紐約梅克出版公司(Mack Publishing Co.)出版之雷明頓醫藥手冊(Remington’s Pharmaceutical Handbook)中之方法，使用其最終用途可接受的賦形劑、稀釋劑、填料及抗結塊劑製備。此等調配物的實例包括錠劑、口嚼錠、食物棒、懸浮劑等等。
根據本發明之組成物亦可包含其他具有補充或其他有用活性的成分。此等成分的實例係源自諸如菊苣之植物的粉末及/或萃取物，及精油諸如八角及茴香。
將根據本發明之組成物的一些實例記述於下。
使根據本發明之組成物進行水結合容量(WBC)及潤脹指數試驗。
1.水結合容量試驗測量WBC可評估在酸性環境(類似於胃環境)中可被單一原料或原料之混合物結合的水量。
方法：將20克pH＝2(利用HCl酸化)的溶液加至0.5克的乾物質中。攪拌直至得到均勻懸浮液為止，然後靜置30分鐘，以使水可被本體吸收，並因此而潤脹。將懸浮液在4000 RPM下離心30分鐘，並將顆粒自上清液分離。結合水的能力將等於顆粒重量減去被空白試樣所滯留的水分。將所得值除以無水樣品的總重量。結果記述於表1。
2.潤脹指數根據記述於官方藥典(Official Pharmacopoeia)第11版中之方法，利用中性pH的去離子水進行測量。原料的細分程度係將在稍後階段存在於產物中者。潤脹指數係於使1克活性成分在水性液體中潤脹4小時後，其與黏著在其上之膠漿所佔據之體積的毫升數。結果記述於表2。
Claims (6)
- 一種醫用營養補充及膳食營養組成物，其包含：
- 如申請專利範圍第1項之組成物，其中，梨果仙人掌係以經脫水莖漿的形態存在。
- 如申請專利範圍第1或2項之組成物，其亦包含冷凍乾燥膠漿之混合物，其中，該膠漿之混合物係由源自亞麻種子(亞麻(Linum usitatissimum ))、藥蜀葵根(黃蜀葵(Althea officinalis ))及萊姆花(菩提花(Tilia platyphyllos ))的冷凍乾燥膠漿所構成。
- 如申請專利範圍第3項之組成物，其中，該冷凍乾燥膠漿之混合物係以在1及10%之間的濃度範圍存在。
- 如申請專利範圍第4項之組成物，其中，該冷凍乾燥膠漿之混合物係以3±2%之濃度範圍存在。
- 一種申請專利範圍第1項之醫用營養補充及膳食營養組成物用於製造經設計為調節體重之產品的用途，其中，該組成物包含選用之冷凍乾燥膠漿之混合物。
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| US9171343B1 (en) | 2012-09-11 | 2015-10-27 | Aseko, Inc. | Means and method for improved glycemic control for diabetic patients |
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| CN103416598B (zh) * | 2013-07-04 | 2014-07-02 | 新疆农业大学 | 一种微囊包被卵黄源胆囊收缩素抗体的制备方法 |
| US9486580B2 (en) | 2014-01-31 | 2016-11-08 | Aseko, Inc. | Insulin management |
| US9898585B2 (en) | 2014-01-31 | 2018-02-20 | Aseko, Inc. | Method and system for insulin management |
| US11081226B2 (en) | 2014-10-27 | 2021-08-03 | Aseko, Inc. | Method and controller for administering recommended insulin dosages to a patient |
| EP3050023B1 (en) | 2014-10-27 | 2021-08-25 | Aseko, Inc. | Subcutaneous outpatient management |
| WO2016085322A1 (en) | 2014-11-26 | 2016-06-02 | Inqpharm Group Sdn Bhd | A dietary fibre composition |
| AU2016308953B2 (en) | 2015-08-20 | 2020-09-10 | Aseko, Inc. | Diabetes management therapy advisor |
| JP2023540469A (ja) * | 2020-08-26 | 2023-09-25 | アボカ エッセ．ピ．ア．ソシエタ アグリコラ | メタボリックシンドロームの治療に使用するための新たな特性を有する新規の系 |
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| CN1076623A (zh) * | 1993-03-09 | 1993-09-29 | 沈阳药学院 | 仙人掌制剂及其制备方法 |
| US5498436A (en) * | 1993-12-30 | 1996-03-12 | Fmc Corporation | Coprocessed galactomannan-glucomannan |
| US6228213B1 (en) * | 1997-09-19 | 2001-05-08 | University Of Nebraska-Lincoln | Production of microcrystalline cellulose by reactive extrusion |
| FR2823423B1 (fr) * | 2001-04-11 | 2004-08-27 | Bio Serae Laboratoires | Preparation a base de cactaceae ayant la propriete de fixer les graisses, et procede d'obtention d'une telle preparation |
| US20030138547A1 (en) * | 2002-01-22 | 2003-07-24 | Mars, Incorporated | Weight management system for animals |
| US20040265398A1 (en) * | 2002-04-25 | 2004-12-30 | Fleischner Albert M. | Herbal composition for weight control |
| CA2483002C (en) * | 2002-04-26 | 2011-02-01 | F. Hoffmann-La Roche Ag | New pharmaceutical composition |
| WO2004096252A1 (en) * | 2003-04-25 | 2004-11-11 | Primavera Biosciences, Inc. | Compositions and methods for weight loss |
| CN1217601C (zh) * | 2003-08-29 | 2005-09-07 | 北京东方兴企食品工业技术有限公司 | 一种膳食纤维食品及其制作方法 |
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- 2005-12-28 PT PT05028547T patent/PT1679009E/pt unknown
- 2005-12-28 AT AT05028547T patent/ATE405177T1/de not_active IP Right Cessation
- 2005-12-28 ES ES05028547T patent/ES2313197T3/es active Active
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Also Published As
| Publication number | Publication date |
|---|---|
| DE602005009123D1 (de) | 2008-10-02 |
| CN1853666A (zh) | 2006-11-01 |
| CN1853666B (zh) | 2012-09-05 |
| US20060147560A1 (en) | 2006-07-06 |
| PL1679009T3 (pl) | 2009-04-30 |
| TW200637566A (en) | 2006-11-01 |
| EP1679009A1 (en) | 2006-07-12 |
| HK1093904A1 (en) | 2007-03-16 |
| EP1679009B1 (en) | 2008-08-20 |
| EP1679009B8 (en) | 2008-10-08 |
| ES2313197T3 (es) | 2009-03-01 |
| ATE405177T1 (de) | 2008-09-15 |
| ITMI20050010A1 (it) | 2006-07-06 |
| PT1679009E (pt) | 2008-11-18 |
| US7410660B2 (en) | 2008-08-12 |
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