TW201334705A - 胃造口用半固形營養劑 - Google Patents
胃造口用半固形營養劑 Download PDFInfo
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Abstract
本發明提供一種抑制胃食道逆流的發生之胃造口用半固形營養劑。本發明之胃造口用半固形營養劑係包含糖質7至17重量%與蛋白質1.5至6.5重量%者,其在37℃之人工腸液中以每分鐘65轉旋轉攪拌60分鐘後,通過網篩經測定殘渣之重量的形狀變化評價試驗而算出之上述殘渣比例所示之殘存率為20%以下(含20%),以10%以下(含10%)為佳。
Description
本發明係有關一種胃造口用半固形營養劑。
由於食道與氣管相接,故經由吞嚥的動作使喉頭蓋堵住氣管的入口之喉頭以防止誤嚥。正常人在誤嚥時,係經咳嗽或嗆咳使誤入的食物等自氣管排出,即便因誤嚥而使食物中的細菌等進入氣管或肺部,可因免疫力而驅逐該細菌,因此在一般的社會生活上幾乎毫無影響。
然而,對於高齡者或因腦的疾病等之影響而降低吞嚥功能者,並無法順利地吞嚥食物,並且,因喉頭蓋的活動力降低,故亦因咳嗽或嗆咳的動作遲鈍而易於誤嚥,更因誤嚥而使該食物中的細菌進入氣管或肺部,如此,因免疫力的下降等而無法驅逐細菌,因而有容易感染細菌性肺炎之問題。此問題,即使在對食物之經口攝取困難的患者施行一種穿過患者的腹壁與胃壁所裝設的胃造口之孔口藉由插入之營養管子而注入患者的胃的經皮內視鏡胃造口術(Percutaneous Endoscopic Gastrostomy)中,同樣地亦會因胃食道逆流而發生食物中的細菌進入氣管或肺部的情形。
通常,胃食道逆流係指防止胃液逆流之括約肌(Sphincter)的機能降低,食道及胃之蠕動的降低、腹壓的上昇、胃液的分泌增加、攝取過多食物等各種要因合併在一起而引發者,目前的狀況,胃食道逆流並無根本的治療方
法,係以對症療法為主。並且,高齡者或因腦血管障礙等之影響而無法經口攝取者,免疫力亦顯著地降低,如因胃食道逆流使胃的內容物到達肺部時,即會併發嚴重的肺炎,最嚴重的情況會有因呼吸衰竭而致死之虞慮。例如在非專利文獻1中已有報告指出胃造口患者之10%至20%為胃食道逆流之高危險群患者。
因此,PEG法中使用之所謂胃造口用半固形營養劑,不僅作為營養劑之機能,且胃食道逆流之降低在提高胃造口營養之安全性的觀點上為重要課題之一。作為解決該課題之技術可列舉如專利文獻1及專利文獻2。
在該專利文獻1中揭示一種具有形態保持性之半固形狀之經腸營養劑,具體上係在液狀營養劑中添加洋菜使半固形化、或是藉由加蛋凝固而賦予形態保持性之經腸營養劑可用於防止胃食道逆流。半固形化之營養劑在介由胃造口管注入胃內之過程中,營養劑雖斷裂,但斷裂之營養劑在胃中亦具有形態保持性,藉此而刺激胃之蠕動,其結果可認為是防止胃食道逆流。
在該專利文獻2中揭示營養組成物之製造階段中,半固形化之膠體化營養劑之製造技術,其用意與專利文獻1相同,係提供一種調配洋菜而賦予形態保持性之半固形狀營養組成物者。
另一方面,在非專利文獻2所示之研究中顯示,可用於防止胃食道逆流之營養組成物不一定限定於類似固體之具有形態保持性之物質者。亦即,係記載將10000mPa.s
以上(含10000mPa.s)之高黏性的半固形狀組成物以1次約200g以上(含200g)之量,以約10分鐘左右之短時間從胃造口管注入,藉此而給胃壁帶來弛緩,其結果,介由存在於胃壁之伸張感器,從食道側朝小腸側引發強烈的胃蠕動,藉此而抑制胃內容物之逆流。
【專利文獻1】日本特開2007-211032號公報
【專利文獻2】日本特開2006-182767號公報
【非專利文獻1】Coben RM:Gastroenterogy 1994
【非專利文獻2】「從胃造口之半固形短時間注入法之手法與其形跡」合田文則編著從胃造口之半固形短時間攝取法指南-目標為提高胃造口患者之QOL齒醫藥出版19-26頁(2006)
由近年來之研究,半固形狀之營養組成物可抑制胃造口患者之胃食道逆流之點為優異者已臻明顯,依據半固形狀之組成物的性狀,會對營養成分的消化及吸收帶來不良影響。亦即,經注入胃內之營養組成物作為食團(bolus)殘留在胃內之間與胃酸混合,源自膠體狀之半固形組成物的
食團直接以該形態送入小腸。為使市售之半固形營養劑半固形化所使用之膠體化劑原本為難以消化之物質,因此,食團因消化不足而直接排泄,且營養成分在體內之利用性降低而有因患者的狀態而招致營養不良之虞慮。因此,如專利文獻1之賦予形態保持性的經腸營養劑及專利文獻2之膠體化營養劑,即使可抑制胃內容物之逆流,亦產生引起營養不良之問題。因此,除了防止胃食道逆流,亦尋求消化.吸收性亦佳的良好之半固形流質食物(liquid food)。
第二點係,除了營養成分之外,水份管理中之安全性亦為重要課題。以補充水分為目的之半固形狀組成物雖有市售,惟營養組成物之個別購入會有經濟上的負擔之問題,故在大多數的情況下,將稱為「增稠劑(thickening agent)」之粉末增黏劑溶解於茶水等之中並從胃造口管注入,惟要乾淨地溶解增稠劑會有耗費功夫等之問題。第三點係,胃造口患者大多認定的副作用係有下痢、便秘等之問題。近年來已闡明要維持大腸機能者係以食物纖維為重要,在半固形營養組成物中亦尋求食物纖維的適當處方。
於此,本發明之一型態中,提供一種營養劑,其可抑制、防止胃食道逆流,且在腸內之食團的分解性優異。本發明之其它型態中,提供一種維持半固形狀組成物之物性而使水分含量增加之半固形組成物,藉此而提供一種在補充水分時可抑制、防止胃食道逆流之營養劑。本發明之其它型態中,提供一種營養劑,其具有適當種類與量之食物纖維,故可用於大腸機能的維持。
本發明者等因鑑於上述以往技術之問題點而專心致志反覆研究,結果發現一種包含糖質7至17質量%與蛋白質1.5至6.5質量%之胃造口用半固形營養劑,其在37℃之人工腸液中以每分鐘65轉旋轉攪拌60分鐘後,通過孔徑300μm之網篩經測定殘渣之重量的形狀變化評價試驗而算出之上述殘渣比例所示之殘存率為20%以下(含20%),遂而解決上述課題。
如依本發明,即可抑制、防止胃造口患者頻繁發作的胃食道逆流。
如依本發明,可提供一種胃造口用半固形營養劑,係將充分量之營養成分、水分以及食物纖維,即使對消化道機能衰退的纏綿於病榻之高齡患者,亦可以容易消化之狀態安全地補充。
本發明之第一型態係一種胃造口用半固形營養劑,係包含糖質7至17質量%與蛋白質1.5至6.5質量%者,其在37℃之人工腸液中以每分鐘65轉旋轉攪拌60分鐘後,通過孔徑300μm之網篩經測定殘渣之重量的形狀變化評價試驗而算出之上述殘渣比例所示之食團殘留率為20%以下
(含20%)。
藉此,可提供一種抑制、防止胃食道逆流,且在腸內之食團分解性優異的營養劑。
本說明書中之「其在37℃之人工腸液中以每分鐘65轉旋轉攪拌60分鐘後,通過(孔徑300μm之)網篩經測定殘渣之重量的形狀變化評價試驗而算出之上述殘渣比例所示之食團殘留率」係指,添加胃造口用半固形營養劑在37℃之人工腸液中以每分鐘65轉旋轉攪拌60分鐘後,通過網篩,藉由測定殘渣之重量的形狀變化評價試驗,相對於添加在人工腸液中之上述胃造口用半固形營養劑的上述殘渣重量之比例(%),具體而言,係將人工腸液(pH6.8;關東化學(股)製造)500ml饋入槳式溶離試驗儀(富山產業公司製造)之燒杯中,並在37℃中加溫30分鐘,在該溶液內將作為試料之胃造口用半固形營養劑100g以注射器注入,然後,不使試料接觸溶離試驗儀之槳的方式,以每分鐘65轉之速度旋轉60分鐘後,停止該溶離試驗儀,並與分散在液內之試料一起的溶液通過60個篩孔之網篩(孔徑300μm:JIS規格用TEST-SIEVE),將殘留在網篩上的固形份作為殘渣並測定其重量,相對於最初之胃造口用半固形營養劑之重量100g,求算出殘渣重量(g)之比例作為食團殘留率(%)。
後述實施例中,在測定相對於人工胃液之食團殘留率(%)時,將人工胃液(pH1.2;關東化學(股)製造)500ml饋入溶離試驗儀(富山產業公司製造)之燒杯中,並在37℃中加
溫30分鐘,在該溶液內將試料100g以注射器注入。溶離試驗儀之槳以不接觸試料的方式,以每分鐘3轉之速度旋轉5分鐘後,停止該溶離試驗儀,並與分散在液內之試料一起的溶液通過60個篩孔之網篩,將網篩上的固形份作為殘渣並測定其重量。食團殘留率(%)係相對於注入量100g所求算出殘渣重量(g)之比例(%)。
而且,其中之網篩係指依JIS所規定之標準網篩之支數,60個篩孔係指孔徑尺寸300μm之網篩。
本發明之胃造口用半固形營養劑在人工腸液中的食團殘留率為20%以下(含20%),以10%以下(含10%)為佳,惟在人工胃液中,以槳式轉數3rpm之低速攪拌5分鐘後的食團殘留率係以80%以上(含80%)為佳,以85%以上(含85%)更佳。
本發明中,在剛注入胃造口用半固形營養劑之後,胃內殘留80%以上(含80%)者確認為使胃開始蠕動所需者。然而,60分鐘後經由人工胃液之食團殘留率係與人工腸液相同,確認為降低至10%以下(含10%)者。
追究其原因,其係本發明之胃造口用半固形營養劑雖為糊狀,但剛以胃造口管注入後,在胃內維持該食團形狀而給胃壁帶來弛緩,結果刺激伸張感器,並在注入5分鐘左右,引發強烈的胃蠕動者。B型旋轉黏度計中之黏度為10000 mPa.s以上(含10000 mPa.s)時,以3 rpm攪拌5分鐘後之食團殘留率為80%以上(含80%),在蠕動開始時會維持充分的食團形狀。
本發明之胃造口用半固形營養劑係除了糖質與蛋白質以外,以包含水及/或食物纖維者為佳,本發明之胃造口用半固形營養劑係以糖質、蛋白質、水分及增黏成分作為必要成分,在該胃造口用半固形營養劑中,依所需,以進一步包含食物纖維者更佳。
並且,在該胃造口用半固形營養劑中,可進一步含有作為任意成分之選自脂質、礦物質、維生素、胺基酸、胜肽、食物纖維、酸化劑、乳化劑、添加劑以及香料所成組群中之至少一種。
本發明之胃造口用半固形營養劑的水分量以91至177ml水分/100Kcal更佳,該水分量以112至144ml水分/100Kcal又更佳。
如上所述,由提高胃造口營養之安全性的觀點,從臨床現場要求在水分補充時抑制/防止胃食道逆流。對目前患者之水分補充係進行下述方法:(a)在認為食間的胃食道逆流機率較少之時間帶以胃造口注入補充液狀之水分;(b)在醫院內添加增稠劑以作成半固形狀之濃漿等補充水分;(c)預先添加增黏劑或膠體化劑作成半固形狀而補充水分。然而,胃食道逆流頻繁發作之患者中,無法避免食間期的發作機率,在院內調劑中利用增稠劑者較為麻煩,且購買市售之半固狀的水分補給食品方面則有醫療經濟上的問題。然而,本發明之胃造口用半固形營養劑中,由於可使胃造口患者含有所需之水分量,故可抑制/防止在水分補給中的胃食道逆流。由於作為組成物之營養劑的熱量濃度之低下
以及固形分濃度之低下,黏度亦降低,故經由增黏成分之調配量的調整,即可作成合適的黏度以及具有食團殘留率之半固形的營養組成物。入院患者一天所需的水分量係例如,依管餵食管理指引,25歲以上(含25歲)且未滿55歲者之體重以每公斤需有35ml、55歲以上(含55歲)且未滿65歲者之體重以每公斤需有30ml、65歲以上(含55歲)者之體重以每公斤需有25ml,在攝取胃造口用半固形營養劑作為三餐時,亦可一併攝取一天所需的水分量。
而且,該水分量為91至177ml水分/100Kcal者係指本發明之胃造口用半固形營養劑的熱量每100Kcal為91至177ml之水分量包含在該胃造口用半固形營養劑中。
本發明之胃造口用半固形營養劑每1g之熱量係以0.5至0.9Kcal/g為佳,以112至144 Kcal/g更佳。
通常,一天1000 Kcal左右之經營養管理的臥床高齡患者,如將營養組成物之熱量濃度設為0.5至0.9Kcal/g左右時,可同時補給必要之能量與必要之水分量。
本發明之胃造口用半固形營養劑,其黏度以10000至40000mPa.s為佳,以15000至305000 mPa.s更佳,以20000至25000 mPa.s又更佳。同時,該黏度範圍係指將物品溫度為25℃時所測定之黏度範圍,使用後述實施例中所用之B型黏度計,以(No.64轉子之)轉速6rpm計測黏度。
如上所述,為了引發作為胃食道逆流之因素之一的胃之接納性弛緩(receptive relaxation),無須作成固化之保形性,如注入10000mPa.s以上(含10000mPa.s)之高黏性的
半固形狀組成物,則產生弛緩,在注入後數分鐘之內即引發強烈的胃蠕動。因此,黏度在10000至40000mPa.s之範圍時,注入後數分鐘之內即引發強烈的胃蠕動。
本發明之胃造口用半固形營養劑之pH係以pH3.0以上(含3.0)4.0以下(含4.0)者為佳。
pH為pH3.0以上(含3.0)4.0以下(含4.0)時,具有適度的酸味,在風味之觀點上為佳,且可避免因與胃酸的接觸使蛋白凝固而引發的胃造管阻塞等之問題。並且,由於為酸性pH故可防止管內雜菌的繁殖。
本發明之胃造口用半固形營養劑係以包含食物纖維者為佳。由此而可用於大腸機能的維持。食物纖維自以往係以防止下痢為主要目的而調配在流食中,惟在半固形營養組成物之短時間注入法中,為促進消化管運動而可確實地抑制經管投予所引起的下痢,由此觀點,並不一定需要食物纖維的調配。然而,發酵性食物纖維利用被腸內細菌合成代謝所產生之短鏈脂肪酸經確認可用於大腸機能的維持,故由適當調配量之食物纖維即可維持大腸機能。
因此,本發明之胃造口用半固形營養劑中的食物纖維之含量可依適用對象者而適當地調節,惟相對於該胃造口用半固形營養劑之總量,係以0.2至1.4質量%者為佳,以0.5至1.1質量%者更佳。
並且,食物纖維大致上分為:經由存在於人的大腸之厭氧菌(anaerobic bacteria)所發酵而得的發酵性食物纖維、不經發酵之非發酵性食物纖維,本發明之非發酵性食
物纖維可列舉如:低分子化海藻酸鈉、聚葡萄糖(polydextrose)、洋菜、三仙膠、洋車前子種皮、織維素以及結冷膠等。另外,本發明之發酵性食物纖維可列舉如:果膠、低分子化果膠、瓜爾膠、瓜爾膠分解物、瓜爾膠水解物、低分子化瓜爾膠、甜菜纖維、難消化性糊精、阿拉伯膠、聚三葡萄糖(pullulan)、羅望子膠、水溶性大豆食物纖維(WSSF)等,以瓜爾膠分解物為佳。
本發明之胃造口用半固形營養劑中使用之食物纖維可單獨使用發酵性食物纖維或非發酵性食物纖維,或可將兩種食物纖維混合使用。
而且,對於發酵性、非發酵性之分類,係以食新發第0217002號食物纖維之能量換算係數為基準,能量換算係數(kcal/g)0 kcal/g者係非發酵性,1或2 kcal/g者係發酵性。
並且,所含之發酵性食物纖維與非發酵性食物纖維以1:1.5至1:0.67之質量比的比例者為佳,所含之發酵性食物纖維與非發酵性食物纖維以1:1.2至1:0.8之質量比的比例者更佳。
所含之發酵性食物纖維與非發酵性食物纖維為1:1.5至1:0.67之比例時,在胃造口營養之安全性的觀點上為佳。
如上述之,本發明之胃造口用半固形營養劑係包含:以上述成分之糖質與蛋白質為必要之營養素,以及依所需之食物纖維。
本發明之糖質如為生物體所吸收而產生能量源者即
可,而無特別限制,可列舉如:單糖、雙糖以及多糖。單糖之具體例可列舉如:葡萄糖、果糖、半乳糖等。雙糖之具體例可列舉如:蔗糖、乳糖、麥芽糖、異麥芽糖、海藻糖等。多糖之具體例可列舉如:澱粉(直鏈澱粉、支鏈澱粉)、加工澱粉(Modified Starch)、白砂糖、三溫糖、細砂糖、糊精等。該等之中,以使用糊精、加工澱粉、白砂糖者為佳。
糊精係數個α-葡萄糖經糖苷鍵(Glycosidic bond)而聚合之物質的總稱,可將澱粉水解而得。糊精係,小腸內之分解速度變緩而使吸收緩慢,因此可防止血糖急驟上升。並且,藉由使用糊精而可減低胃造口用半固形營養劑之滲透壓,並可預防滲透壓性的下痢。糊精可使用α-葡萄糖之高聚合度的高分子糊精以及α-葡萄糖之低聚合度的低分子糊精的任一者,惟以使用可更減低滲透壓之高分子糊精者為佳。此外,低分子糊精亦稱為麥芽糊精,一般係3至5個α-葡萄糖聚合而成者。
該糊精可自行調製,亦可使用市售者。在調製糊精時,可將習知澱粉,例如:玉米、蠟質種玉米、小麥、米、蠟質種米(waxy rice)、蠟質高梁(waxy milo)、豆類(蠶豆、綠豆、小紅豆等)、馬鈴薯、蕃薯、樹薯等中所含的澱粉,以習知方法進行水解即可調製。另外,市售之糊精可適用如TK-16(松谷化學工業(股)製造)等。上述糖質可單獨使用亦可將2種以上混合使用。
該白砂糖係指含有主成分之砂糖97.8至98.00%,且含
有水分與轉化糖(葡萄糖與果糖之混合物)各1%左右之結晶狀的多糖。
該加工澱粉係於澱粉中進行物理性、酵素性或化學性處理者。在進行該處理之情況下,物性,例如對水的溶解性、糊化溫度、加熱溶解時之黏性安定性、物性安定性等會有變化。
上述物理性之處理可列舉如:溼熱處理、高周波處理、放射線處理、漂白處理、酸處理、鹼處理等。上述酵素處理可列舉經由α-澱粉酶、β-澱粉酶、葡萄糖澱粉酶7、異澱粉酶(isoamylase)、普魯蘭酶(pullulanase)等之酵素處理等。上述化學性處理可列舉如:氧化處理、酯化處理、乙醯化處理、醚化處理、交聯處理等。
經上述處理而得之加工澱粉並無特別限制,可列舉如:焙燒糊精、酸處理澱粉、鹼處理澱粉、漂白澱粉、酵素處理澱粉、澱粉乙醇酸鈉(Sodium Starch Glycolate)、澱粉磷酸鈉(sodium starch phosphate)、乙醯化己二酸交聯澱粉、乙醯化氧化澱粉、乙醯化磷酸交聯澱粉、辛烯基丁二酸鈉澱粉、乙酸澱粉、氧化澱粉、羥丙基化磷酸交聯澱粉、羥丙基澱粉、磷酸交聯澱粉、磷酸化澱粉、磷酸單酯化磷酸交聯澱粉等。該等之中,以使用乙醯化磷酸交聯澱粉、羥丙基化磷酸交聯澱粉者為佳。
加工澱粉可自行調製,亦可使用市售品。自行調製時,係將習知澱粉,例如在上述澱粉中進行上述之物理性處理、酵素處理以及化學性處理之至少一種以上時即可調
製。市售品係可使用例如:WMS(乙醯化磷酸交聯澱粉:松谷化學工業(股)製造)、Matsutani Suisen(乙醯化磷酸交聯澱粉:松谷化學工業(股)製造)、Farinex VA70WM(羥丙基化磷酸交聯澱粉:松谷化學工業(股)製造)、Farinex VA70X(羥丙基化磷酸交聯澱粉:松谷化學工業(股)製造)、Farinex VA70C(羥丙基化磷酸交聯澱粉:松谷化學工業(股)製造)等。
上述加工澱粉可單獨使用,亦可將2種以上混合使用。
本發明之胃造口用半固形營養劑中的糖質含量可依所適應之對象而適當地調整,惟相對於該胃造口用半固形營養劑之總量,以7至17質量%為佳,以9至13質量%更佳。
本發明之蛋白質雖無特別限制,然可列舉如:胺基酸、肽、植物性蛋白質以及動物性蛋白質等。
胺基酸可列舉如:纈胺酸(valine)、白胺酸(leucine)、異白胺酸(isoleucine)、離胺酸(lysine)、甲硫胺酸(methionine)、苯丙胺酸(phenylalanine)、蘇胺酸(threonine)、色胺酸(Tryptophan)、組胺酸(histidine)等之必需胺基酸;以及甘胺酸(glycine)、丙胺酸(alanine)、絲胺酸(serine)、半胱胺酸(cysteine)、天冬醯胺酸(asparagine)、麩醯胺酸(glutamine)、脯胺酸(proline)、酪胺酸(tyrosine)、天冬胺酸(aspartic acid)、麩胺酸(glutamic acid)、精胺酸(arginine)等的非必需胺基酸。該等之外,亦包含4-羥基脯胺酸、5-羥基離胺酸、γ-羧基麩胺酸、O-磷絲胺酸(O-Phosphoserine)、O-磷酸酪胺酸(O-Phosphotyrosine)、
O-乙醯絲胺酸(O-acetylserine)、Nω-甲基精胺酸、焦麩胺酸(Pyroglutamic acid)、M-N-甲醯甲硫胺酸(N-formylmethionine)等之修飾胺基酸;鳥胺酸(ornithine)、瓜胺酸(Citrulline)、γ-胺基丁酸(GABA)、甲狀腺素(thyroxine)、S-腺苷基甲硫胺酸(s-Adenosylmethionine)等之特殊胺基酸。並且,上述胺基酸該等可為立體異構物(鏡像異構物(enantiomer)、非鏡像異構物(Diastereomer))、可為位置異構物(Regioisomer),亦可為該等之混合物。更且,上述胺基酸可為無機酸鹽(鹽酸鹽等)、有機酸鹽(乙酸鹽等)、可在生物體內水解之酯體(甲酯等)之型態。
肽可使用2個以上(含2個)之上述胺基酸介由肽鍵(醯胺鍵)聚合而得者。該肽可為雙肽、三肽、寡肽(胺基酸約為10個左右)、多肽(胺基酸約為數十個至數百個左右)之任一者。另外,部分之寡肽,例如:乳胜肽、酪蛋白十二肽、含有纈酪胺酸(Valyl tyrosine)之沙丁魚肽(sardine peptide)等係具有降壓作用等之保健機能。
植物蛋白質可列舉如:米等之榖類、大豆、豆腐等之豆類等中所含的蛋白質。並且,動物蛋白質可列舉如:蛋、肉類、魚貝類、牛奶等中所含的蛋白質。而且,大豆蛋白質與膽酸結合而具有促進膽固醇排泄等之保健機能。
該等之中,係以使用將牛奶(乳清)作為原料之乳清蛋白質、牛奶中所含的酪蛋白蛋白質、大豆蛋白質者為佳,以使用乳清蛋白質更佳。該乳清蛋白質可列舉如:濃縮乳清蛋白(WPC:whey protein concentrate)、乳清分離蛋白
(WPI:whey protein isolate)、水解乳清胜肽(WPH:Whey Peptide Hydrolysate)等。WPC及WPI等可使用市售者,市售者之例可列舉如:WPI18855(Fonterra公司製造)、WPI18822(Fonterra公司製造)、WPI1895(Fonterra公司製造)、WPC392(Fonterra公司製造)、WPC80(Fonterra公司製造)、WPC7009(Fonterra公司製造)等。上述蛋白質可單獨使用,亦可將2種以上混合使用。
本發明之胃造口用半固形營養劑中的蛋白質含量可依適應之對象者而適當地調整,惟相對於該營養劑總量,以1.5至6.5質量%為佳,以1.5至5.6質量%更佳。
本發明之胃造口用半固形營養劑的必要成分之增黏成分可列舉如:洋菜、明膠、果膠、瓜爾膠、刺槐豆膠、蒟蒻聚甘露糖、三仙膠、羅望子膠、卡拉膠、丙二醇、羧甲基纖維素、結冷膠、塔拉膠(Tara gum)羅望子膠、車前子膠(psyllium seed gum)、阿拉伯膠、卡特蘭多醣(curdlan)、聚三葡萄糖(pullulan)、褐藻酸鈉(Sodium alginate)、黃蓍膠(Tragacanth gum)、刺梧桐樹膠(karaya gum)、矽酸鎂鋁(veegum)等。本發明之胃造口用半固形營養劑中可含有增黏成分,惟以下述之觀點,有控制黏性之必要。亦即,上述課題之「(1)依半固形狀之組成物的性狀的不同而會有影響營養成分的消化/吸收的可能性」係,主要多見於消化器官之機能低下的高齡患者,特別是將以洋菜等之增黏成分而固化的流食注入胃造口時,部分流食作為固形物而直接排泄之病例,進一步暗示礦物質等之營養成分的消化/吸收
性低下之可能性。並且,依增黏成分之種類及調配量、液溫等之條件,組成物之胃造口用半固形營養劑的性狀變的不同,一般較少量之增黏成分僅賦予增黏作用。另外,較多量之增黏成分,例如在添加多量之洋菜時,則使營養素封入固化之膠體內部。並且,如上述之,由於增黏成分本身為難消化性多糖,以人體的消化酵素並無法分解,即使使用下消化道(lower digestive tract)的腸內細菌亦難以分解,因此在所攝取之營養劑的膠體不充分損壞之情形下,即無法吸收取自膠體內部的營養素,使得營養素在生物體內的利用效率變低。然而,以未達到固化之量的增黏成分調製低黏性時,損壞性提高而使營養素的消化/吸收變佳,無法引起胃之接納性弛緩,因此無法誘發胃蠕動,而有胃食道逆流之抑制/防止效果受損之虞。在此,本發明中,一邊維持有效地抑制/防止胃食道逆流之高黏性物性,一邊調整食團分解性優異之胃造口用半固形營養劑的增黏成分之種類與量而達成。
因此,胃造口用半固形營養劑中的增黏成分之含量,相對於胃造口用半固形營養劑之總量,係以0.05至1.5質量%為佳,以0.2至1.0質量%更佳。
而且,本發明之洋菜如為具有包含洋菜粉(agarose)與酸性洋菜(agaropectin)之反覆單元的高分子即可,大多使用源自龍鬚菜(Gracilaria verrucosa)、粗龍鬚菜(Gracilaria gigas)、石花菜(Gelidium amansii)、雞毛菜(Pterocladia capillacea)、伊谷草(Ahnfeltia plicata)等之源自紅藻類的素
材,惟並不限於洋菜原料之來源,而且,洋菜之形態係以棒狀、粉末、顆粒等之種類存在,惟本發明中並無特別限定。
本發明之胃造口用半固形營養劑的任意成分之脂質並無特別限制,可列舉如:飽和脂肪酸、不飽和脂肪酸、植物油、動物性油脂、魚油等。
飽和脂肪酸可列舉如:辛酸、癸酸、月桂酸、棕櫚酸、硬脂酸等。
不飽和脂肪酸可列舉如:油酸、棕櫚油酸、亞麻油酸、花生油酸、α-次亞麻油酸、二十碳五烯酸(EPA)、二十二碳六烯酸(DHA:Docosahexaenoic acid)等。並且,EPA及DHA係具有抑制血中膽固醇上升之作用、抑制中性脂肪上升之作用等的保健機能。
植物油可列舉如:椰子油、玉米油、棉籽油、橄欖油、棕櫚油、棕櫚仁油、花生油、菜籽油、紅花子油(紅花油)、芝麻油、大豆油、葵花籽油、杏仁油、腰果油、榛子油、澳洲胡桃油、盟可戈油(mongongo oil)、美國山核桃油、松子油、開心果油(pistachio oil)、核桃油、葫蘆籽油、油瓜油(Cucurbita foetidissima oil)、南瓜籽油、西瓜籽油、莧紫花油(Amaranthus oil)、杏油、蘋果油、榛果樹油(Argan Oil)、酪梨油、棕櫚仁油(Babassu Oil)、辣木籽油(moringa seed oil)、婆羅洲脂(Borneo Tallow)、好望角美樹堅果油、可可脂、刺槐豆油(carob oil)、羽葉棕櫚果油(cohune palm)、芫荽籽油、野生芒果(Irvingia gabonensis)油、亞麻
仁油、葡萄籽油(grape seed oil)、大麻籽油(hemp oil)、木棉籽油(kapok oil)、拉曼油(Lallemantia iberica)、瑪乳拉果油(Marula Oil)、白芒花籽油(Meadowfoam Seed Oil)、芥子油(mustard oil)、肉豆蔲脂(nutmeg butter)、秋葵油、木瓜油、紫蘇油、巴西堅果油、松子油、罌栗油(Poppy Oil)、西洋李油、藜麥油(quinoa oil)、皂脚油(nigar seed oil)、米糠油、青刺果油(royle oil)、聖加銀麒油(sacha inchi oil)、山茶油、薊油(Cirsium oil)、番茄籽油(tomato-seed oil)、小麥油、荏油、向日葵油、胚芽油、椰子油、花生油等。
動物性油脂可列舉如:豬油、牛脂、乳脂等。
魚油可列舉如:鯖魚、鮭魚、鰤魚、沙丁魚、秋刀魚等之魚油。
該等之中,以使用無法在人體內合成之亞麻油酸以及α-次亞麻油酸或包含該等之脂質為佳。上述脂質可單獨使用,亦可混合2種以上使用。
胃造口用半固形營養劑中之脂質含量可依適用對象者而適當地調節,惟相對於胃造口用半固形營養劑之總量,係以0.8至3.5質量%者為佳,以1.0至3.1質量%者更佳。
並且,本發明之胃造口用半固形營養劑的任意成分之胺基酸、酞係與上述例示相同,因此在此省略。
本發明之胃造口用半固形營養劑的任意成分之礦物質係作為營養成分之必要的礦物質,可列舉例如:鈉、鉀、鈣、鎂、磷、氯、鐵、鋅、銅、錳等。2價陽離子可列舉如:作為營養素之上述鈣、鎂、鐵、鋅、銅、錳等,該等
離子可作為無機鹽或有機酸鹽而含在營養素中,此時,被包含的形態可為葡萄糖酸鈣、氯化鎂、氯化鉀、氯化鈉、磷酸二氫鈉、檸檬酸三鉀等。該等礦物質可單獨使用,亦可混合2種以上使用。
胃造口用半固形營養劑中之礦物質含量,可依適用對象者而適當地調節。相對於胃造口用半固形營養劑每100g,各礦物質之較佳含量係如下所述。
鈉:較佳為5至6000mg,更佳為10至3500mg;鉀:較佳為1至3500mg,更佳為25至1800mg;鈣:較佳為10至2300mg,更佳為30至300mg;磷:較佳為1至3500mg,更佳為25至1500mg;鎂:較佳為1至740mg,更佳為10至150mg;
鐵:較佳為0.1至55mg,更佳為1至10mg;鋅:較佳為0.1至30mg,更佳為1至15mg;銅:較佳為0.01至10mg,更佳為0.06至6mg;碘:較佳為0.1至3000μg,更佳為1至150μg;錳:較佳為0.01至11mg,更佳為0.1至4mg;硒:較佳為0.1至450μg,更佳為1至35μg;鉻:較佳為0.1至40μg,更佳為1至35μg;鉬:較佳為0.1至320μg,更佳為1至25μg;本發明之營養素的任意成分之維生素可為水溶性維生素或脂溶性維生素之任一者,例如,該脂溶性維生素可列
舉如:維生素A(視黃醇)、維生素D(麥角鈣化固醇(Ergocalciferol)、膽鈣化固醇(Cholecalciferol))、維生素E(生育酚(Tocopherol)、生育三烯醇(Tocotrienol))、維生素K(葉醌(phylloquinone)、甲萘醌類(menaquinone))等,該水溶性維生素可列舉如:維生素B1(硫胺素(Thiamine))、維生素B2(核黃素(Riboflavin))、維生素B3(菸鹼酸(Niacin))、維生素B5(泛酸(Pantothenic acid))、維生素B6(吡哆醛(Pyridoxal)吡哆胺(Pyridoxamine)、吡哆醇(Pyridoxine))、維生素B7(生物素(Biotin))、維生素B9(葉酸)、維生素B12(氰鈷胺(Cyanocobalamin)、羥鈷胺(Hydroxocobalamin))、維生素C(抗壞血酸)等。該等維生素並不限於水溶性維生素或脂溶性維生素,可單獨使用,亦可混合2種以上使用。
胃造口用半固形營養劑中之維生素含量可依適用對象者而適當地調節。通常,對於脂溶性維生素,係添加不產生過量徵候(Excess symptom)之量,而對於水溶性維生素之添加量並無限制。胃造口用半固形營養劑每100g之各維生素的較佳含量係如下述。
維生素A:較佳為0至3000μg,更佳為20至200μg;維生素D:較佳為0.1至50μg,更佳為0.1至5.0μg;維生素E:較佳為0.2至800mg,更佳為1至10mg;維生素K:較佳為0.5至1000μg,更佳為2至50μg;
本發明之胃造口用半固形營養劑的任意成分之酸化劑並無特別限制,可使用乙酸、檸檬酸、琥珀酸、乳酸、蘋果酸、酒石酸、葡萄糖酸、磷酸等。該等酸化劑可單獨使用,亦可混合2種以上使用。
本發明之胃造口用半固形營養劑的任意成分之乳化劑並無特別限制,可列舉如:卵磷脂、皂素、酪蛋白鈉等之天然乳化劑;脂肪酸甘油酯、脂肪酸山梨醇酐酯、丙二醇脂肪酸酯、蔗糖脂肪酸酯等之合成乳化劑等。該等乳化劑可單獨使用,亦可混合2種以上使用。
本發明之胃造口用半固形營養劑的任意成分之添加劑可列舉如:pH調整成分、甜味料、香料等,胃造口用半固形營養劑中的添加劑含量係適當地調整。
該pH調整成分係可使用檸檬酸、葡萄糖酸、琥珀酸、
碳酸鉀、碳酸氫鈉、二氧化碳、乳酸、乳酸鈉、檸檬酸鈉等。
該甜味料並無特別限制,可使用苯丙胺酸、木糖醇、阿斯巴甜、蔗糖素(sucralose)、乙醯磺胺酸鉀、甘草酸二鈉等。
該添加物可列舉如:葡萄糖酸銅、葡萄糖酸鋅、抗壞血酸葡糖苷(Ascorbic Acid 2-Glucoside)、環糊精等之習知的食品添加物。
該等之pH調整成分、甜味料以及添加物可單獨使用,亦可混合2種以上使用。
本發明之胃造口用半固形營養劑的任意成分之香料並無特別限制,可列舉如:苯乙酮、α-戊桂皮醛(α-Amylcinnamaldehyde)、大茴香醛(anisaldehyde)、苯甲醛、乙酸苄酯、苯甲醇、桂皮醛、桂皮酸、檸檬醛(citral)、香茅醛(citronellal)、香茅醇(Citronellol)、癸醛、癸醇、乙醯乙酸乙酯、桂皮酸乙酯、癸酸乙酯、乙香草醛、丁香酚、香草醇、乙酸異戊酯、丁酸異戊酯、苯乙酸異戊酯、dl-薄荷醇、1-薄荷醇、柳酸甲酯、胡椒醛、丙酸、萜品醇(terpineol)、香草醛、右旋龍腦(d-Borneol)等。該等香料可單獨使用,亦可混合2種以上使用。
本發明之胃造口用半固形營養劑可適用在醫療以及食品等之領域上。
在醫療領域中,胃造口用半固形營養劑可使用作為經腸營養劑,可適用於經腸營養法。使用胃造口之投予係以
難以經口攝取而腸的運作機能正常之高齡者或患者為對象。
本型態之胃造口用半固形營養劑係包含營養素、必要之水分、食物纖維以及其它之任意成分。上述營養素之含量宜含有可滿足以經腸營養法為目的之生物體所需要之卡路里、氮源等之需要的量。並且,胃造口用半固形營養劑之水分量宜考量所投予之高齡者或患者之狀態及水分管理等而加以設定。
對於在本型態之胃造口用半固形營養劑中添加必要成分以外之成分方面並無特別限制,可因應適用投予方法、胃造口用半固形營養劑之高齡者或患者的狀態等而適當地設定。例如,在使用胃造口之投予時,從防止打嗝時的不適感之觀點,以添加甜味料、酸化劑及香料等為佳。並且,在需要全身管理之患者中,為維持營養狀態而宜含有所需的維生素及礦物質。在消化機能低落之高齡者等中,為改善因胃造口用半固形營養劑之投予所引起的便秘,以添加食物纖維者為佳。
如使用本發明之胃造口用半固形營養劑,即難以引發胃食道逆流或吸入性肺炎(aspiration pneumonia)。進一步可提升保存性及在使用胃造口之投予中的胃造口管在注入時的操作性等。
並且,由於本型態之胃造口用半固形營養劑可抑制胃食道逆流之發生,並可同時攝取水分及能量,因此,例如:藉由黏度的調節,可改善對使用胃造口之投予中的胃造口
管的附著性以及胃造口用半固形營養劑之消化性。並且,藉由熱量的調節,可使適用胃造口用半固形營養劑之高齡者或患者的營養管理趨於簡便。更且,藉由pH的調節,可改善保存性及清涼感。該黏度、熱量、pH等可在藉由適當地調節胃造口用半固形營養劑中之成分以及該含量之情況下而受到控制。
本發明之胃造口用半固形營養劑可適用在食品方面。上述營養素之含量宜依作為對象之消費者而進行適當地選擇。
對於在本型態之胃造口用半固形營養劑中添加必要成分以外之成分方面並無特別限制,可因應所要製造之食品而進行適當地選擇。例如:在對胃造口用半固形營養劑中賦予清涼感時,宜添加pH調整成分使pH成為酸性者。並且,要得到認可為特定之保健用食品時,必須使其含有例如上述之食物纖維、難消化性果寡糖、糖醇、檸檬酸蘋果酸鈣(CCM)以及酪蛋白磷酸胜肽(CPP:casein phosphopeptide)等中之規定者(保健機能成分)。更且,要呈現營養機能食品之標示時,必須使上述之維生素、礦物質等中之規定者(營養成分)含量在規格基準之範圍內。
如依本型態之胃造口用半固形營養劑即可抑制胃食道逆流的發生,故可補給適合的能量等,而且,可成為嗜好性優異的食品。
並且,由於本型態之胃造口用半固形營養劑可同時補充水分及營養分,故可依使用目的進行各種製品的開發。
例如:藉由調整水分量即可製造具有不同食感的胃造口用半固形營養劑。而且,藉由調整熱量即可製造因應所需的胃造口用半固形營養劑。此外,藉由調整pH即可製造賦予所要之清涼感的胃造口用半固形營養劑。
以下係呈示本發明之胃造口用半固形營養劑的較佳製造方法之一例。
本型態之胃造口用半固形營養劑可依習知方法製造,例如在加溫之水中藉由添加營養素、洋菜以及其它所要的成分並加以攪拌即可製造。此外,準備加溫之水中溶有洋菜之溶液、與溫水中溶有蛋白、糖質或加工澱粉等之溶液,並添加其它所要的成分之任意者,再將2種溶液進行混合、攪拌即可製造。
所得之胃造口用半固形營養劑係例如充填在經連續殺菌後之容器中即可完成製品。該連續殺菌之方法並無特別限制,惟可列舉如:超高溫短時間(UHT)殺菌(又稱瞬間殺菌)、熱水殺菌、間歇式殺菌以及該等之組合。上述殺菌宜在短時間內進行。藉由短時間內進行殺菌,即可抑制胃造口用半固形營養劑中所含成分的劣化。
本發明之第二型態係將平均每支相當於300至400Kcal的本發明之胃造口用半固形營養劑充填至容器中的完成容器充填之胃造口用半固形營養劑。
作為充填該胃造口用半固形營養劑之容器並無特別限定,可使用習知容器。該容器可列舉如:利樂包(Tetra Pak)、紙製飲料罐(cartocan)、玻璃容器、金屬罐、鋁箔袋(aluminum
pouch)、塑膠容器等。該等之中,以使用塑膠容器者為佳。
上述塑膠容器之原料宜使用聚乙烯(PE)、聚丙烯(PP)、聚氯乙烯(PVC)、聚乙酸乙烯酯(PVAc)、聚碳酸酯(PC)、聚對苯二甲酸丁二酯(PBT)、聚萘二甲酸乙二酯(PEN)、乙烯-乙酸乙烯酯共聚物(EVA)、乙烯-α-烯烴共聚物、多氟碳(polyfluorocarbon)以及聚醯亞胺等。
上述塑膠容器中,可進一步地將下述者組合使用:包含聚對苯二甲酸乙二酯(PET)、聚萘二甲酸乙二酯(PEN)、乙烯-乙烯醇共聚物(EVOH)、聚偏二氯乙烯(PVDC)、聚丙烯腈、聚乙烯醇、聚醯胺、聚酯等之阻氣性樹脂;鋁箔、鋁蒸鍍薄膜、氧化矽皮膜、氧化鋁覆膜等之阻氣性無機層。藉由裝設該阻氣層即可防止因氧氣或水蒸氣等所引起的胃造口用半固形營養劑之劣化。
上述容器亦可被遮光。藉由該遮光即可抑制例如胃造口用半固形營養劑中所含的維生素A、維生素B2、維生素C及維生素K等因光而導致的劣化。
上述容器可使用市售者,例如可使用:軟袋(Fuji Seal International(股)製造)、水壺袋(凸版印刷(股)製造)、加接頭水壺袋(Spouch;大日本印刷(股)製造);鋁箔包裝(Cheer pack;細川洋行(股)製造)等。
以下,列舉實施例而具體地說明本發明,惟本發明並不限定於該等。同時,實施例中所使用之「份」或「%」,如無特別註明,係表示「質量份」或「質量%」。
「胃造口用半固形營養劑之製造」
在5L之不鏽鋼水桶中投入調和水1200份,以水浴加溫至80℃以上(含80℃)。接著,添加洋菜的Ultra Agar UX30(伊那食品工業(股)製造)20份使之溶解。將所得之溶液冷卻至50至60℃,添加蛋白質的WPI895(乳清分離蛋白(Whey Protein Isolate):Fonterra公司製造)140份以及糖質之TK-16(糊精:松谷化學工業公司製造)400份。於50℃下將脂質的植物油60份、乳化劑的甘油脂肪酸酯10份以及加工澱粉(Modified Starch)之WMS(乙醯化磷酸交聯澱粉:松谷化學工業公司製造)35份混入該溶液中混合成分散液。更且,適當地添加作為維生素之水溶性綜合維生素0.3份、脂溶性綜合維生素1.5份;作為礦物質之葡萄糖酸鈣20份、氯化鎂10份、氯化鉀3.2份、氯化鈉0.2份、磷酸二氫鈉10份以及檸檬酸三鉀6份;作為食物纖維之瓜爾膠水解物25份;綜合酵母0.5份;作為酸化劑之檸檬酸25份、蘋果酸8份以及乳酸27.3份;抗壞血酸二葡糖苷0.6份、葡萄糖酸鋅0.294份;葡萄糖酸銅0.029份以及香料1.5份並加以攪拌。並添加水使所得混合液成為4000份,再使之溶解分散成為均一狀態。
將所得溶液在連續殺菌後,使每袋成為200份之方式充填至附栓口之鋁箔袋中,在90℃下進行10分鐘之容器殺菌處理。上述容器殺菌處理之後,在冷卻下製造袋裝之半固形化之胃造口用半固形營養劑。
除了將蛋白質變更為WPC392(濃縮乳清蛋白:Fonterra公司製造)150份之外,藉由與實施例1相同之方法,製造半固形化之胃造口用半固形營養劑。
除了將蛋白質變更為大豆蛋白(Proleena 900;不二製油(股)製造)140份以外,藉由與實施例1相同之方法,製造半固形化之胃造口用半固形營養劑。
以下表1呈示實施例1至3之胃造口用半固形營養劑的組成、熱量及pH。
將TM-Mini(Terumeal Mini咖啡口味:Terumo(股)製造)2000份在40℃之水中加熱30分鐘後,水2000份分散於洋菜20份中,加以熬煮,確認洋菜的溶解,將加熱後之TM-Mini 2000份添加在含有經分散之洋菜的溶液2020份中,攪拌30秒鐘後得到混合溶液4020份。然後,將該混合溶液以導管式接頭注射器(Terumo(股)製造)吸取,在4℃下靜置12小時,將固化者作為比較試樣。
「胃造口用半固形營養劑之評定」
一般的能量換算係數,亦即,依據糖質4kcal/g、蛋白質44kcal/g、脂質9kcal/g以及食物纖維24kcal/g,由下述式求算出半固形化營養劑之熱量。
熱量(kcal/g)=糖質(g/g)×4(kcal/g)+蛋白質(g/g)×4(kcal/g)+脂質(g/g)×9(kcal/g)+食物纖維(g/g)×2(kcal/g)(pH)
使用pH測定器(METTLER TOLEDO MP220;METTLER TOLEDO公司)測定半固形化營養劑之pH。將其結果呈示於上述表1。
以肉眼判斷實施例1至3之胃造口用半固形營養劑以及比較試樣之性狀。將其結果呈示於上述表1。
對於上述實施例1至3之胃造口用半固形營養劑以及比較例所製造之比較試樣,進行黏度測定。該黏度測定係使用以下之測定機器與條件而進行。
同時,黏度測定之結果係呈示於後述之表2。
測定機器:B型黏度計
廠牌:BROOKFIELD
型式:DV-II+Pro
測定條件:旋轉速度6rpm
測定時間1min
轉子編號64
測定溫度室溫(25℃)
對於上述實施例1至3之胃造口用半固形營養劑以及比較例所製造之比較試樣,進行人工胃液與人工腸液中之形狀變化評定試驗之殘留率測定。該形狀變化評定試驗之殘留率測定係使用以下之測定機器與條件進行。
在溶出試驗機(富山產業)之燒杯中加入人工胃液(pH1.2關東化學公司製造)500mL,在37℃中加溫30分鐘之後,在該溶液內分別將100g之試料(上述實施例1至3之胃造口用半固形營養劑以及比較例所製造之比較試樣)以注射器注入。使溶出試驗機之攪拌器不接觸試料之方式,以每分鐘3轉之速度旋轉5分鐘之後,停止溶出試驗機,與分別分散在液內之試料一起,將溶液倒在60網眼之
網篩上,將網篩上之固形分作為殘渣並測定其重量。食團殘留率(%)係相對於注入燒杯中之量100g的殘渣重量(g)之比例(%)而求算出。將其結果呈示於下述表2、表3-1及表3-2。
在溶出試驗機(富山產業)之燒杯中加入人工腸液(pH6.8關東化學公司製造)500mL,在37℃中加溫30分鐘之後,在該溶液內分別將100g之試料(上述實施例1至3之胃造口用半固形營養劑以及比較例所製造之比較試樣)以注射器注入。使溶出試驗機之攪拌器不接觸試料之方式,以每分鐘65轉之速度旋轉60分鐘之後,停止溶出試驗機,與分別分散在液內之試料一起,將溶液倒在60網眼之網篩上,將網篩上之固形分作為殘渣,並測定其重量。食團殘留率(%)係相對於注入燒杯中之量100g的殘渣重量(g)之比例(%)而求算出。將其結果呈示於下述表2、表3-1及表3-2。
將實施例1之胃造口用半固形營養劑注入人工腸液,且以每分鐘65轉之速度旋轉60分鐘之後,其形狀變化評定試驗之模樣以第1圖之照片表示。第1圖中,左側的照片係表示溶出試驗機之燒杯從側面觀察之狀態,右側的照片係表示溶出試驗機之燒杯從上面觀察之狀態。
而且,將比較例1之比較試樣注入人工腸液,且以每分鐘65轉之速度旋轉60分鐘之後,其形狀變化評定試驗之模樣係如第2圖之照片所示。第2圖中,左側的照片係
表示溶出試驗機之燒杯從側面觀察之狀態,右側的照片係表示溶出試驗機之燒杯從上面觀察之狀態。
以下之表3-1及表3-2係將上述表2中之實施例1至3的胃造口用半固形營養劑及比較例中製造之比較試樣分別的殘留率圖形化者。
從上述第1、2圖、表1、表3-1以及表3-2,可確認本發明之胃造口用半固形營養劑在腸內之分解性優異。
【第1圖】呈示本發明之實施例的胃造口用半固形營養劑之形狀變化評價試驗之情形的照片。
【第2圖】呈示比較例之胃造口用半固形營養劑之形狀變化評價試驗之情形的照片。
Claims (6)
- 一種胃造口用半固形營養劑,係包含糖質7至17質量%與蛋白質1.5至6.5質量%者,其在37℃之人工腸液中以每分鐘65轉旋轉攪拌60分鐘後,通過孔徑300μm之網篩經測定殘渣之重量的形狀變化評價試驗而算出之上述殘渣比例所示之食團(bolus)率為20%以下(含20%)。
- 如申請專利範圍第1項之胃造口用半固形營養劑,其在25℃之黏度為10000至40000 mPa.s。
- 如申請專利範圍第1或2項之胃造口用半固形營養劑,其每g之熱量為0.5至0.9 kcal。
- 如申請專利範圍第1至3項中任一項之胃造口用半固形營養劑,其水分量係91至177 ml水分/100 Kcal。
- 如申請專利範圍第1至4項中任一項之胃造口用半固形營養劑,其pH為4.0以下(含pH為4.0)。
- 如申請專利範圍第1至5項中任一項之胃造口用半固形營養劑,其包含1:1.5至1:0.67之比例的發酵性食物纖維與非發酵性食物纖維。
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