CN104394849A - 胃瘘用半固态营养剂 - Google Patents
胃瘘用半固态营养剂 Download PDFInfo
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- CN104394849A CN104394849A CN201280070582.XA CN201280070582A CN104394849A CN 104394849 A CN104394849 A CN 104394849A CN 201280070582 A CN201280070582 A CN 201280070582A CN 104394849 A CN104394849 A CN 104394849A
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- gastric fistula
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- semisolid nutrient
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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
- A23L33/21—Addition of substantially indigestible substances, e.g. dietary fibres
-
- 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
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
Abstract
本发明提供一种抑制了胃食管反流的发生的胃瘘用半固态营养剂。本发明涉及一种胃瘘用半固态营养剂,其含有7~17重量%的糖类和1.5~6.5重量%的蛋白质,所述胃瘘用半固态营养剂在37℃的人工肠液中以每分钟65转搅拌60分钟后,置于筛上,通过测定残渣的重量的形状变化评价试验算出的表示上述残渣的比例的残留率为20%以下,优选为10%以下。
Description
技术领域
本发明涉及胃瘘用半固态营养剂。
背景技术
由于食道和气管相邻,所以通过吞咽的动作使喉头盖堵住作为气管入口的喉头,从而防止误咽。健康人误咽的情况,会通过咳嗽或呛咳将误入的食物等从气管排出,假如,即使由于误咽使食物中的细菌等进入气管、肺,通过免疫也能驱逐该细菌,因此对通常的社会生活几乎没有影响。
然而,老年人、或因脑疾病等的影响导致吞咽功能下降的人不能很好地吞咽食物,并且由于喉头盖的活动下降,所以咳嗽或呛咳之类的动作也迟钝、容易误咽,进而若因误咽导致该食物中的细菌进入气管、肺,则由于免疫力下降等而不能驱逐细菌,因此存在容易感染细菌性肺炎的问题。该问题在对食物的经口摄取困难的患者实施的经皮内窥镜的胃造瘘术(PEG法)中,也同样因胃食管反流导致食物中的细菌进入气管、肺而引起,所述经皮内窥镜的胃造瘘术是借助被插入跨越患者的腹壁和胃壁而设置的胃瘘的瘘孔中的营养管向患者的胃中注入。
通常而言,胃食管反流据说是因为防止胃液反流的括约肌的功能下降、食道或胃的蠕动运动下降、腹压的上升、胃液的分泌增加、过量的食物摄取等各种要素重合而引起的,目前没有根本上治疗胃食管反流的方法,主要是对症疗法。另外,老年人、因脑血管疾病等而不能经口摄取的患者的免疫力也显著下降,若因胃食管反流导致胃内容物到达肺,则可能合并发生严重的肺炎,最差的情况由于呼吸衰竭等而导致死亡。例如,非专利文献1中报道了胃瘘患者的10%~20%是胃食管反流的高危患者。
因此,对于PEG法中使用的所谓的胃瘘用半固态营养剂而言,从提高胃瘘营养的安全性的观点考虑,不仅作为营养剂发挥作用而且减少胃食管反流为重要的课题之一。作为解决所述课题的技术,可以举出专利文献1及专利文献2。
该专利文献1中公开了具有形态保持性的半固态状的经肠营养剂,具体为通过向液态营养剂中加入琼脂使其半固态化、或加入鸡蛋使其凝固从而赋予了形态保持性的经肠营养剂对于防止胃食管反流有用。认为经半固态化的营养剂在经由胃瘘管被注入胃内的过程中,营养剂被分离开,但被分离开的营养剂在胃内也具有形态保持性,由此刺激胃的蠕动运动,结果防止胃食管反流。
该专利文献2中公开了在营养组合物的制造阶段被半固态化了的凝胶化营养剂的制造技术,其意图与专利文献1相同,在于提供配合琼脂而赋予了形态保持性的半固态状营养组合物。
另一方面,非专利文献2所示的研究表明,对于防止胃食管反流有用的营养组合物并不一定限定于与固体类似的具有形态保持性的物质。即,记载了通过以1次约200g以上的量、约10分钟左右的短时间从胃瘘管注入10000mPa·s以上的高粘性的半固态状组合物,导致胃壁的松弛,其结果,借助存在于胃壁的牵张感受器(stretchreceptor)引发从食道侧向小肠侧的强有力的胃蠕动,由此抑制胃内容物的反流。
专利文献1:日本特开2007-211032号公报
专利文献2:日本特开2006-182767号公报
非专利文献1:Coben RM:Gastroenterogy 1994
非专利文献2:“胃瘘からの半固态短時間注入法の手技とそのエビデンス”(自胃瘘的半固态短时间注入法的手艺和其根据)合田文则编自胃瘘的半固态短时间摄取法指南-以提高胃瘘患者的QOL为目的医齿药出版19页-26页(2006)
发明内容
通过近年来的研究,逐渐明确了半固态状的营养组合物在能够抑制胃瘘患者的胃食管反流这一方面优异,但由于半固态状的组合物的性状,可能对营养成分的消化·吸收产生不良影响。即,被注入胃内的营养组合物在胃内以食块的形式贮留期间被与胃酸混和,来自凝胶状的半固态组合物的食块在保持其形态的情况下被送入小肠。市售的用于使半固态营养剂半固态化的凝胶化剂本来就是难消化性的物质,因此食块以消化不充分的状态被排泄,营养成分在体内的利用性下降,所以根据患者的状态的不同有可能导致营养不良。因此,如专利文献1那样的赋予了形态保持性的经肠营养剂、专利文献2的凝胶化营养剂,虽然抑制了胃内容物的反流,但产生了引起营养不良的问题。因而,寻求一种防止胃食管反流,并且消化、吸收性也良好的半固态流质食物。
第二,与营养成分同样,水分管理中的安全性也为重要的课题。市售有以水分补给为目的的半固态状组合物,但存在与营养组合物分别购入的经济上的负担的问题,因此,多数情况下,将称作“增稠剂”的粉末增粘剂溶解在茶等中从胃瘘管注入,但存在卫生地溶解增稠剂需要耗费工夫等的问题。第三,作为被较多胃瘘患者承认的副作用,存在腹泻、便秘等问题。近年来,阐明了食物纤维对于维持大肠功能很重要,在半固态营养组合物中也寻求食物纤维的适宜的处方。
因此,本发明的一个实施方式提供一种能够抑制、防止胃食管反流、在肠内的食块的分解性优异的营养剂。本发明的另一个实施方式通过提供在保持作为半固态状组合物的物性的状态下使水分含量增加的半固态组合物,从而提供一种能够抑制、防止水分补给时的胃食管反流的营养剂。本发明的其他实施方式提供由于具有适当的种类和量的食物纤维从而对于维持大肠功能有用的营养剂。
本发明人等鉴于上述现有技术的问题反复深入研究,结果通过下述胃瘘用半固态营养剂解决了上述课题,所述胃瘘用半固态营养剂含有7~17质量%的糖类和1.5~6.5质量%的蛋白质,其在37℃的人工肠液中以每分钟65转搅拌60分钟后,置于网孔为300μm的筛上,通过测定残渣重量的形状变化评价试验算出的表示上述残渣的比例的残留率为20%以下。
根据本发明,可以抑制、防止胃瘘患者中多发的胃食管反流。
根据本发明,可以提供即使对消化道功能衰退的卧床不起的高龄患者也能以易消化的状态安全地补给足够量的营养成分、水分、及食物纤维的胃瘘用半固态营养剂。
附图说明
[图1]图1为表示本发明的实施例的胃瘘用半固态营养剂的形状变化评价试验的情况的照片。
[图2]图2为表示比较例的胃瘘用半固态营养剂的形状变化评价试验的情况的照片。
具体实施方式
本发明的第一实施方式是一种胃瘘用半固态营养剂,其含有7~17质量%的糖类和1.5~6.5质量%的蛋白质,所述胃瘘用半固态营养剂在37℃的人工肠液中以每分钟65转搅拌60分钟后,置于网孔300μm的筛上,通过测定残渣的重量的形状变化评价试验算出的表示上述残渣的比例的食块残留率为20%以下。
由此,可以抑制、防止胃食管反流,可以提供在肠内的食块的分解性优异的营养剂。
本说明书中的“在37℃的人工肠液中以每分钟65转搅拌60分钟后,置于(网孔为300μm的)筛上,通过测定残渣重量的形状变化评价试验算出的表示上述残渣的比例的食块残留率”,是指在加入了胃瘘用半固态营养剂的37℃的人工肠液中以每分钟65转搅拌60分钟后,置于筛上,通过测定残渣重量的形状变化评价试验,上述残渣的重量相对于加入在人工肠液的上述胃瘘用半固态营养剂的比例(%),具体而言,在桨式溶出试验机(富山产业公司制)的烧杯内加入500mL人工肠液(pH6.8关东化学株式会社制),在37℃下加热30分钟,用注射器向该溶液内注入作为试样的胃瘘用半固态营养剂100g,然后,以溶出试验机的桨不接触试样的方式在每分钟65转的速度下转动60分钟,然后停止该溶出试验机,将溶液与分散在液内的试样一同置于60目的筛(网孔300μm:JIS标准用TEST-SIEVE)上,将残留在筛上的固态成分作为残渣,测定其重量,算出残渣重量(g)相对于初始的胃瘘用半固态营养剂的重量100g的比例作为食块残留率(%)。
在后述的实施例中,测定相对于人工胃液而言的食块残留率(%)时,在溶出试验机(富山产业)的烧杯内放入500mL人工胃液(pH1.2关东化学株式会社制),在37℃下加热30分钟后,用注射器向该溶液内注入100g的试样。以溶出试验机的桨不接触试样的方式在每分钟3转的速度下转动5分钟,然后停止溶出试验机,将溶液与分散在液内的试样一同置于60目的筛上,将筛上的固态成分作为残渣,测定其重量。食块残留率(%)作为残渣重量(g)相对于注入的量100g的比例(%)算出。
需要说明的是,此处,所谓目,是指JIS中规定的标准筛的号数,对于60目而言,是指网孔尺寸300μm的筛。
本发明的胃瘘用半固态营养剂在人工肠液中的食块残留率为20%以下,优选为10%以下,在人工胃液中、以桨转数3rpm的低速搅拌5分钟后的食块残留率优选为80%以上,较优选为85%以上。
本发明中,确认了胃瘘用半固态营养剂在刚注入后、在胃内残留80%以上对于使胃蠕动开始来说是必须的。但是,确认了60分钟后的基于人工胃液的食块残留率与人工肠液同样地下降至10%以下。
其原因是,本发明的胃瘘用半固态营养剂虽为糊状,但经胃瘘管刚注入后在胃内维持其食块形状,带来胃壁的松弛,结果刺激牵张感受器,在注入后5分钟左右,引发强有力的胃蠕动。如果利用B型旋转粘度计测定的粘度为10000mPa·s以上,则以3rpm搅拌5分钟后的食块残留率为80%以上,维持足以开始胃蠕动的食块形状。
本发明的胃瘘用半固态营养剂除含有糖类及蛋白质以外,优选还含有水及/或食物纤维,本发明的胃瘘用半固态营养剂以糖类、蛋白质、水分及增粘成分作为必需成分,根据需要,较优选该胃瘘用半固态营养剂中进一步含有食物纤维。
另外,该胃瘘用半固态营养剂中可以进一步含有选自脂质、矿物质、维生素、氨基酸、肽、食物纤维、酸味剂、乳化剂、添加剂、及香料中的至少一种作为任选成分。
本发明的胃瘘用半固态营养剂的水分量较优选为91~177ml水分/100Kcal,该水分量进一步优选为112~144ml水分/100Kcal。
如上所述,根据胃瘘营养的安全性提高的观点,有抑制、防止在临床实践中进行水分补给时的胃食管反流的要求。目前对于患者的水分补给采用以下方法进行:(a)在两餐之间被认为是胃食管反流风险比较小的时间带通过胃瘘注入来补给液态的水分,(b)在医院内,用添加增稠剂制成半固态状的白开水等补给水分,(c)事先添加增粘剂或胶凝剂以半固态状补给水分。但是,对于胃食管反流频发的患者来说,无法避免两餐之间期间的风险,在医院内通过配制制剂而利用增稠剂很烦杂,并且对于购入市售的半固态状的水分补给食品来说,在医疗经济上存在问题。但是,本发明的胃瘘用半固态营养剂可以含有对胃瘘患者而言必需的水分量,因此,可以抑制、防止水分补给中的胃食管反流。由于作为组合物的营养剂的热量浓度下降及固态成分浓度下降,导致粘度也下降,因此通过调整增粘成分的配合量,可以制成具有理想的粘度及食块残留率的半固态状的营养组合物。对于入院患者一天的必需水分量,例如若根据经管营养管理指南,则25岁以上且小于55岁为每1kg体重35ml,55岁以上且小于65岁为每1kg体重30ml,65岁以上为每1kg体重25ml,可以在作为饭食摄取胃瘘用半固态营养剂时也一并摄取1天的必需水分量。
需要说明的是,该水分量为91~177ml水分/100Kcal,是指相对于本发明的胃瘘用半固态营养剂的每100Kcal热量,该胃瘘用半固态营养剂中含有91~177ml的水分量。
本发明的胃瘘用半固态营养剂每1g的热量优选为0.5~0.9kcal/g,更优选为112~144kcal/kg。
在通常一天以1000kcal左右进行营养管理的卧床不起的高龄患者的情况下,若营养组合物的热量浓度为0.5~0.9kcal/g左右,则可同时补给必要的能量和必要的水分量。
本发明的胃瘘用半固态营养剂的粘度优选为10000~40000mPa·s,较优选为15000~30000mPa·s,进一步优选为20000~25000mPa·s。需要说明的是,该粘度范围是以产品温度为25℃测定的粘度范围,使用后述的实施例中使用的B型粘度计,在6rpm(No.64转子的)转速下测量粘度。
如上所述,为了引发作为胃食管反流的原因之一的胃的容受性松弛,不需要固化的保形性,若注入10000mPa·s以上的高粘性的半固态状组合物,则发生松弛,注入后数分钟以内引发强有力的胃蠕动。因此,若粘度在10000~40000mPa·s的范围内,则在注入后数分钟以内引发强有力的胃蠕动。
对于本发明的胃瘘用半固态营养剂的pH,优选pH为3.0以上4.0以下。
pH为3.0以上4.0以下时,具有适度的酸味,从味道的观点考虑优选,并且可以避免起因于由与胃酸的接触引起的蛋白凝固的胃瘘管的阻塞等问题。另外,由于为酸性pH,所以可以防止管内的杂菌的繁殖。
本发明的胃瘘用半固态营养剂优选含有食物纤维。由此,对大肠功能的维持有用。一直以来,食物纤维以防止腹泻为主要目的而被配合在流质食物中,但半固态状营养组合物在短时间注入法中消化道运动得以促进,因此可靠地抑制了起因于经管给予的腹泻,从该观点出发,食物纤维的配合并不是必须的。然而,由于确认了发酵性食物纤维被肠内细菌同化而生成的短链脂肪酸对维持大肠功能有用,所以通过适当配合量的食物纤维能够维持大肠功能。
因此,本发明的胃瘘用半固态营养剂中的食物纤维的含量可根据应用的对象适当调节,相对于该胃瘘用半固态营养剂总量,优选为0.2~1.4质量%,较优选为0.5~1.1质量%。
另外,食物纤维大致分为可被人大肠中存在的厌氧性细菌发酵的发酵性食物纤维、不被发酵的非发酵性食物纤维,对于本发明的非发酵性食物纤维,可以举出低分子化海藻酸Na、聚葡萄糖、琼脂、黄原胶、车前草种皮、纤维素、结冷胶等。另一方面,作为本发明的发酵性食物纤维,可以举出果胶、低分子化果胶、瓜耳胶、瓜耳胶分解物、瓜耳胶水解物、低分子化瓜耳胶、甜菜纤维、难消化性糊精、阿拉伯胶、普鲁兰多糖、罗望子胶、水溶性大豆食物纤维(WSSF)等,优选瓜耳胶分解物。
本发明的胃瘘用半固态营养剂中使用的食物纤维可以单独使用发酵性食物纤维或单独使用非发酵性食物纤维,或混合使用两种食物纤维。
需要说明的是,对于发酵性、非发酵性的分类,基于食新发第0217002号食物纤维的能量换算系数,将能量换算系数(kcal/g)为0kcal/g的食物纤维作为非发酵性,将能量换算系数为1或2kcal/g的食物纤维作为发酵性。
另外,较优选以1∶1.5~1∶0.67的质量比的比例含有发酵性食物纤维和非发酵性食物纤维,进一步优选以1∶1.2~1∶0.8的质量比的比例含有发酵性食物纤维和非发酵性食物纤维。
以1∶1.5~1∶0.67的比例含有发酵性食物纤维和非发酵性食物纤维时,从胃瘘营养的安全性的观点出发是优选的。
如上所述,本发明的胃瘘用半固态营养剂含有作为上述成分的糖类和蛋白质作为必需的营养素、以及根据需要的食物纤维。
作为本发明的糖类,只要被生物体吸收成为能量来源即可,没有特别限定,例如可以举出单糖、二糖、及多糖。作为单糖的具体例,可以举出葡萄糖、果糖、半乳糖等。作为二糖的具体例,可以举出蔗糖(sucrose)、乳糖(lactose)、麦芽糖(maltose)、异麦芽糖、海藻糖等。作为多糖的具体例,可以举出淀粉(直链淀粉、支链淀粉)、加工淀粉、细白砂糖、三温糖、砂糖、糊精等。其中,优选使用糊精、加工淀粉、细白砂糖。
糊精是多个α-葡萄糖通过糖苷键聚合而成的物质的总称,可以将淀粉水解得到。糊精在小肠内的分解速度慢且吸收缓慢,因此能够防止血糖的急剧上升。另外,通过使用糊精,可以降低胃瘘用半固态营养剂的渗透压,能够预防渗透压性的腹泻。作为糊精,可以使用α-葡萄糖的聚合度高的高分子糊精、及α-葡萄糖的聚合度低的低分子糊精中的任一种,但优选使用能够进一步降低渗透压的高分子糊精。需要说明的是,低分子糊精也被称作麦芽糊精,通常是3~5个α-葡萄糖聚合而成的。
该糊精可以自己制备,也可以使用市售品。在制备糊精时,可以利用公知的方法将公知的淀粉(例如玉米、糯玉米、小麦、大米、糯米、糯高粱(waxed milo)、豆(蚕豆、绿豆、红豆等)、马铃薯、甘薯、木薯等中含有的淀粉)水解而制备。另一方面,作为市售的糊精,可以举出TK-16(松谷化学工业株式会社制)等,可以优选使用。上述的糖类可以单独使用,也可以混合2种以上使用。
该细白砂糖,是指含有97.8~98.00%作为主成分的蔗糖、含有水分和转化糖(葡萄糖和果糖的混合物)各约1%左右的结晶状多糖。
该加工淀粉,是对淀粉进行物理处理、酶处理、或化学处理而得到的淀粉。通过进行该处理,物性、例如在水中的溶解性、糊化温度、加热溶解时粘性的稳定性、物性稳定性等发生变化。
作为上述物理处理,可以举出湿热处理、高频处理、放射线处理、漂白处理、酸处理、碱处理等。作为上述酶处理,可以举出利用α-淀粉酶、β-淀粉酶、葡糖淀粉酶7、异淀粉酶、普鲁兰酶等酶进行的处理等。作为上述化学处理,可以举出氧化处理、酯化处理、乙酰化处理、醚化处理、交联处理等。
作为通过上述处理得到的加工淀粉,没有特别限定,可以举出烘焙糊精(roasted dextrin)、酸处理淀粉、碱处理淀粉、漂白淀粉、酶处理淀粉、淀粉乙醇酸钠、淀粉磷酸酯钠、乙酰化二淀粉己二酸酯、乙酰化氧化淀粉、乙酰化二淀粉磷酸酯、辛烯基琥珀酸淀粉钠、乙酸酯淀粉、氧化淀粉、羟丙基化二淀粉磷酸酯、羟丙基淀粉、磷酸酯双淀粉、单淀粉磷酸酯、磷酸化二淀粉磷酸酯(phosphateddistarch phosphate)等。其中,优选使用乙酰化二淀粉磷酸酯、羟丙基化二淀粉磷酸酯。
加工淀粉可以自己制备,也可以使用市售品。在自己制备时,可以通过对公知的淀粉、例如上述的淀粉进行上述的物理处理、酶处理及化学处理中的至少一种以上来制备加工淀粉。作为市售品,例如可以使用WMS(乙酰化二淀粉磷酸酯:松谷化学工业株式会社制)、Matsutani Suisen(乙酰化二淀粉磷酸酯:松谷化学工业株式会社制)、Farinex VA70WM(羟丙基化二淀粉磷酸酯:松谷化学工业株式会社制)、Farinex VA70X(羟丙基化二淀粉磷酸酯:松谷化学工业株式会社制)、Farinex VA70C(羟丙基化二淀粉磷酸酯:松谷化学工业株式会社制)等。
上述加工淀粉可以单独使用,也可以混合2种以上使用。
本发明的胃瘘用半固态营养剂中的糖类的含量可根据应用的对象适当调节,相对于该胃瘘用半固态营养剂总量,优选为7~17质量%,较优选为9~13质量%。
作为本发明的蛋白质,没有特别限定,可以举出氨基酸、肽、植物性蛋白质、及动物性蛋白质等。
作为氨基酸,可以举出缬氨酸、亮氨酸、异亮氨酸、赖氨酸、蛋氨酸、苯丙氨酸、苏氨酸、色氨酸、组氨酸等必需氨基酸;及甘氨酸、丙氨酸、丝氨酸、半胱氨酸、天冬酰胺、谷氨酰胺、脯氨酸、酪氨酸、天冬氨酸、谷氨酸、精氨酸等非必需氨基酸。除了这些之外,还可以包含4-羟基脯氨酸、5-羟基赖氨酸、γ-羧基谷氨酸、O-磷酸丝氨酸、O-磷酸酪氨酸、N-乙酰基丝氨酸、Nω-甲基精氨酸、焦谷氨酸、M-甲酰甲硫氨酸等修饰氨基酸;鸟氨酸、瓜氨酸、γ-氨基丁酸(GABA)、甲状腺素、S-腺苷甲硫氨酸等特殊氨基酸。此外,上述氨基酸可以分别为立体异构体(对映异构体、非对映异构体),也可以为位置异构体,也可以为它们的混合物。进而,上述氨基酸可以为无机酸盐(盐酸盐等)、有机酸盐(乙酸盐等)、能够在生物体内水解的酯类(甲酯等)的形态。
作为肽,可以使用2个以上的上述氨基酸的通过肽键(酰胺键)聚合而成的物质。该肽可以是二肽、三肽、寡肽(氨基酸为约10个左右的肽)、多肽(氨基酸为数十~数百个的肽)中的任一种。需要说明的是,一部分寡肽(例如乳三肽(lactotripeptide)、酪蛋白十二肽、含有缬氨酰酪氨酸(valyl-tyrosine)的沙丁鱼肽(sardine peptide)等)可具有降压作用等保健功能。
作为植物蛋白质,可以举出大米等谷类、大豆、豆腐等豆类等中含有的蛋白质。另外,作为动物性蛋白质,可以举出鸡蛋、肉类、鱼贝类、牛奶等中含有的蛋白质。需要说明的是,关于大豆蛋白,可具有与胆汁酸结合从而促进胆固醇排泄等保健功能。
其中,优选使用以牛奶(乳清)作为原料的乳清蛋白、牛奶中含有的酪蛋白、大豆蛋白,更优选使用乳清蛋白。作为该乳清蛋白,可以举出浓缩乳清蛋白(WPC)、分离乳清蛋白(WPI)、水解乳清肽(WPH)等。WPC、WPI等可以使用市售品,例如作为市售品,可以举出WPI18855(Fonterra公司制)、WPI18822(Fonterra公司制)、WPI1895(Fonterra公司制)、WPC392(Fonterra公司制)、WPC80(Fonterra公司制)、WPC7009(Fonterra公司制)等。上述蛋白质可以单独使用,也可以混合2种以上使用。
本发明的胃瘘用半固态营养剂中的蛋白质的含量可以根据应用的对象适当调节,相对于该营养剂总量,优选为1.5~6.5质量%,更优选为1.5~5.6质量%。
作为用作本发明的胃瘘用半固态营养剂的必需成分的增粘成分,可以举出琼脂、明胶、果胶、瓜耳胶、刺槐豆胶、魔芋葡甘聚糖、黄原胶、罗望胶(tamarind gum)、角叉菜胶、丙二醇、羧甲基纤维素、结冷胶、塔拉胶、罗望子胶(tamarind seed gum)、车前子胶、阿拉伯胶、凝胶多糖、普鲁兰多糖、海藻酸钠、黄蓍胶、刺梧桐树胶、硅酸镁铝(VEEGUM)等。本发明的胃瘘用半固态营养剂中可以含有增粘成分,但从以下观点出发,需要控制粘性。即,作为上述课题的“(1)根据半固态状的组合物的性状不同有可能对营养成分的消化·吸收产生不良影响”,倾向于主要在消化器官的功能下降的老年人患者中多见,特别是在用琼脂等增粘成分固化了的流质食物注入胃瘘时,存在流质食物的一部分以固态物的形态直接被排泄的病例,进一步暗示了矿物质等营养成分的消化·吸收性下降的可能性。另外,根据增粘成分的种类、配合量、液温等条件的不同,作为组合物的胃瘘用半固态营养剂的性状不同,通常较少量的增粘成分仅带来增粘作用。另一方面,添加较多量的增粘成分、例如多量的琼脂时,营养素被封入固化了的凝胶内部。另外,如上所述,由于增粘成分本身为难消化性多糖,所以不被人的消化酶分解,并且也难以被消化道下部的肠内细菌分解,因此,只要被摄取的营养剂的凝胶不充分崩解,就不能吸收被封入凝胶内部的营养素,营养素的生物体内利用效率降低。然而,以不会导致固化的量通过增粘成分调制成低粘性时,崩解性提高,营养素的消化·吸收变得良好,但无法引起胃的容受性松弛,因而无法诱发胃蠕动,有可能损害胃食管反流的抑制·防止效果。因此,本发明中,通过调整增粘成分的种类和量,能够实现维持对于胃食管反流的抑制·防止而言有效的高粘性物性、且食块分解性优异的胃瘘用半固态营养剂。
因此,对于胃瘘用半固态营养剂中的增粘成分的含量,相对于胃瘘用半固态营养剂总量,优选为0.05~1.5质量%,更优选为0.2~1.0质量%。
需要说明的是,本发明的琼脂只要是具有含有琼脂糖和琼脂胶的重复单元的高分子即可,多使用江蓠(Gracilaria verrucosa)、粗江蓠(Gracilaria gigas)、石花菜(Gelidium amansii)、鸡毛菜(Pterocladia capillacea)、伊谷草(Ahnfeltiaplicata)等来自红藻类的原料,但琼脂原料的来源没有限定,另外,作为琼脂的形态,存在棒状、粉末、颗粒等种类,在本发明中没有特别限定。
作为用作本发明的胃瘘用半固态营养剂的任选成分的脂质,没有特别限定,可以举出饱和脂肪酸、不饱和脂肪酸、植物油、动物性油脂、鱼油等。
作为饱和脂肪酸,可以举出辛酸、癸酸、月桂酸、棕榈酸、硬脂酸等。
作为不饱和脂肪酸,可以举出油酸、棕榈油酸、亚油酸、花生四烯酸、α-亚麻酸、二十碳五烯酸(EPA)、二十二碳六烯酸(DHA)等。需要说明的是,对于EPA、DHA,可具有抑制血中胆固醇上升的作用、抑制中性脂肪上升的作用等保健功能。
作为植物油,可以举出椰子油(coconut oil)、玉米油、棉籽油、橄榄油、棕榈油、棕榈仁油、花生油、菜籽油、红花油(safflower oil)、芝麻油、大豆油、葵花籽油、杏仁油、腰果油、榛子油、澳洲坚果油、芥子油(Mongongo oil)、山核桃油、松子油、开心果油、核桃油、葫芦籽油、水牛葫芦油(buffalo gourd oil)、南瓜籽油、西瓜籽油、苋菜油、杏油、苹果籽油、摩洛哥坚果油、鳄梨油、巴巴苏油、辣木油、婆罗洲脂、海角板栗油(cape chestnut oil)、可可脂、角豆树油(cape chestnut oil)、羽叶棕榈油(cohune oil)、芫荽籽油、地咖油(dika oil)、亚麻籽油、葡萄籽油、大麻油、木棉籽油、拉曼油、硬果漆树果油、白芒花籽油、芥菜油、肉豆蔻油、秋葵油、番木瓜籽油、紫苏油、Pequi油、松子油、罂粟籽油、洋李仁油(prune oil)、奎藜籽油(Quinoa oil)、皂脚油(niger seed oil)、米糠油、Royle油、美藤果油(Sacha inchi oil)、山茶油、蓟油、番茄籽油、小麦油、紫苏油、红花油、胚芽油、椰子油、花生油等。
作为动物性油脂,可以举出猪油(猪脂)、牛油(牛脂)、乳脂等。
作为鱼油,可以举出鲐鱼、鲑鱼、鰤鱼、沙丁鱼、秋刀鱼等的鱼油。
其中,优选使用人不能在体内合成的亚油酸及α-亚麻酸、或者含有它们的脂质。上述脂质可以单独使用,也可以混合2种以上使用。
胃瘘用半固态营养剂中的脂质的含量可以根据应用的对象进行适当调节,相对于胃瘘用半固态营养剂总量,优选为0.8~3.5质量%,更优选为1.0~3.1质量%。
另外,作为本发明的胃瘘用半固态营养剂的任选成分的氨基酸、肽与上述例示相同,故此处省略说明。
作为用作本发明的胃瘘用半固态营养剂的任选成分的矿物质,可以举出作为营养成分所必需的矿物质类,例如钠、钾、钙、镁、磷、氯、铁、锌、铜、锰等。作为2价阳离子,可以举出作为营养素的上述钙、镁、铁、锌、铜、锰等离子,这些离子可以以无机盐或有机酸盐的形式包含在营养素中,这种情况下,例如可以以葡糖酸钙、氯化镁、氯化钾、氯化钠、磷酸二氢钠、柠檬酸三钾等的形态含有。这些矿物质可以单独使用,也可以混合2种以上使用。
胃瘘用半固态营养剂中的矿物质的含量可以根据应用的对象等进行适当调节。每100g胃瘘用半固态营养剂中的各矿物质的优选含量如下。
次要元素:
钠:优选5~6000mg、较优选10~3500mg
钾:优选1~3500mg、较优选25~1800mg
钙:优选10~2300mg、较优选30~300mg
磷:优选1~3500mg、较优选25~1500mg
镁:优选1~740mg、较优选10~150mg
必需微量元素:
铁:优选0.1~55mg、较优选1~10mg
锌:优选0.1~30mg、较优选1~15mg
铜:优选0.01~10mg、较优选0.06~6mg
碘:优选0.1~3000μg、较优选1~150μg
锰:优选0.01~11mg、较优选0.1~4mg
硒:优选0.1~450μg、较优选1~35μg
铬:优选0.1~40μg、较优选1~35μg
钼:优选0.1~320μg、较优选1~25μg。
作为用作本发明的营养素的任选成分的维生素,可以为水溶性维生素或脂溶性维生素的任意种类,例如,作为该脂溶性维生素,可以举出维生素A(视黄醇)、维生素D(麦角钙化醇、胆骨化醇)、维生素E(生育酚、生育三烯酚)、维生素K(叶绿醌、甲萘醌)等,作为该水溶性维生素,可以举出维生素B1(硫胺素)、维生素B2(核黄素)、维生素B3(烟酸)、维生素B5(泛酸)、维生素B6(吡哆醛、吡哆胺、吡哆醇)、维生素B7(生物素)、维生素B9(叶酸)、维生素B12(氰钴胺、羟钴胺)、维生素C(抗坏血酸)等。这些维生素不论水溶性维生素或脂溶性维生素,均可以单独使用,也可以混合2种以上使用。
胃瘘用半固态营养剂中的维生素的含量可以根据应用的对象等进行适当调节。通常,对于脂溶性维生素,以不产生过剩症的量进行添加,对于水溶性维生素,添加量没有限定。每100g胃瘘用半固态营养剂的各维生素的优选含量如下。
脂溶性维生素:
维生素A:优选0~3000μg、较优选20~200μg
维生素D:优选0.1~50μg、较优选0.1~5.0μg
维生素E:优选0.2~800mg、较优选1~10mg
维生素K:优选0.5~1000μg、较优选2~50μg
水溶性维生素:
维生素B1:优选0.01~40mg、较优选0.1~5mg
维生素B2:优选0.01~20mg、较优选0.05~5mg
烟酸(当量):优选0.1~300mgNE、较优选0.5~30mgNE
泛酸:优选0.1~55mg、较优选0.2~10mg
维生素B6:优选0.01~60mg、较优选0.1~10mg
生物素:优选0.1~1000μg、较优选1~100μg
叶酸:优选1~1000μg、较优选10~200μg
维生素B12:优选0.01~100μg、较优选0.2~60μg
维生素C:优选1~2000mg、较优选5~1000mg。
作为用作本发明的胃瘘用半固态营养剂的任选成分的酸味剂,没有特别限定,可以使用乙酸、柠檬酸、琥珀酸、乳酸、苹果酸、酒石酸、葡糖酸、磷酸等。这些酸味剂可以单独使用,也可以混合2种以上使用。
作为用作本发明的胃瘘用半固态营养剂的任选成分的乳化剂,没有特别限定,可以举出卵磷脂、皂苷、酪蛋白酸钠等天然乳化剂;甘油脂肪酸酯、失水山梨糖醇脂肪酸酯、丙二醇脂肪酸酯、蔗糖脂肪酸酯等合成乳化剂等。这些乳化剂可以单独使用,也可以混合2种以上使用。
作为用作本发明的胃瘘用半固态营养剂的任选成分的添加剂,可以举出pH调节成分、甜味剂、香料等,胃瘘用半固态营养剂中的添加剂的含量可适当调节。
作为该pH调节成分,可以使用柠檬酸、葡糖酸、琥珀酸、碳酸钾、碳酸氢钠、二氧化碳、乳酸、乳酸钠、柠檬酸钠等。
作为该甜味剂,没有特别限定,可以使用苯丙氨酸、木糖醇、阿斯巴甜、三氯蔗糖、乙酰磺胺酸钾、甘草酸二钠等。
作为该添加物,可以举出葡糖酸铜、葡糖酸锌、抗坏血酸-2葡糖苷、环糊精等公知的食品添加物。
这些pH调节成分、甜味剂、及添加物可以单独使用,也可以混合2种以上使用。
作为用作本发明的胃瘘用半固态营养剂的任选成分的香料,没有特别限定,可以举出苯乙酮、α-戊基肉桂醛、茴香醛、苯甲醛、乙酸苄酯、苯甲醇、肉桂醛、肉桂酸、柠檬醛、香茅醛、香茅醇、癸醛、癸醇、乙酰乙酸乙酯、肉桂酸乙酯、癸酸乙酯、乙基香草醛、丁香酚、香叶醇、乙酸异戊酯、丁酸异戊酯、苯乙酸异戊酯、DL-薄荷醇、L-薄荷醇、水杨酸甲酯、胡椒醛、丙酸、萜品醇、香草醛、D-龙脑等。这些香料可以单独使用,也可以混合2种以上使用。
本发明的胃瘘用半固态营养剂可适用于医疗及食品等领域。
在医疗领域中,胃瘘用半固态营养剂被用作经肠营养剂,可适用于经肠营养法。采用胃瘘的给予能够以经口摄取困难而肠功能正常的老年人、病人等为对象。
本方式涉及的胃瘘用半固态营养剂包含营养素、根据需要的水分、食物纤维、其他任选成分。上述营养素的含量优选以能够满足以经肠营养法为目的的生物体所必需的热量、氮源等的需要的量含有。另外,胃瘘用半固态营养剂的水分量优选考虑给予的老年人、患者的状态和水分管理等进行设定。
对于本实施方式涉及的胃瘘用半固态营养剂中除必需成分以外还可添加的成分,没有特别限定,可以根据给予方法、应用胃瘘用半固态营养剂的老年人、患者的状态等进行适当设定。例如,从采用了胃瘘的给予的情况下防止打嗝时的不适感等的观点出发,优选添加甜味剂、酸味剂、香料等。另外,对于需要全身管理的患者而言,优选含有为了保持营养状态而必需的维生素、矿物质。对于消化功能下降的老年人等来说,为了改善由胃瘘用半固态营养剂的给予导致的便秘,优选添加食物纤维。
利用本实施方式的胃瘘用半固态营养剂,能够变得不易发生胃食管反流、异物性肺炎。进而,也能够提高保存性、采用了胃瘘的给予中的胃瘘管的注入时的操作性等。
另外,本实施方式的胃瘘用半固态营养剂能够抑制胃食管反流的发生,并且能够同时摄取水分和能量,因此,例如通过调节粘度,能够改善采用了胃瘘的投与中的对胃瘘管的附着性、胃瘘用半固态营养剂的消化性。另外,通过调节热量,应用胃瘘用半固态营养剂的老年人、患者的营养管理能变得容易。进而,通过调节pH,能够提高保存性、清凉感。该粘度、热量、pH等可以通过适当调节胃瘘用半固态营养剂中的成分、及其含量来控制。
本发明的胃瘘用半固态营养剂可适用于食品。上述营养素的含量优选根据作为对象的消费者进行适当选择。
对于本实施方式的胃瘘用半固态营养剂中除了必需成分以外还可添加的成分,没有特别限定,可根据要制造的食品进行适当选择。例如,在赋予胃瘘用半固态营养剂清凉感的情况下,优选添加pH调节成分使pH为酸性。另外,在想要作为特定保健用食品获得认可的情况下,例如,需要含有上述的食物纤维、难消化性低聚糖、糖醇、柠檬酸苹果酸钙(CCM)及酪蛋白磷酸肽(CPP)等中规定的物质(保健功能成分)。进而,想要显示为营养功能食品的情况下,例如,需要在规格标准的范围内含有上述维生素、矿物质等中规定的物质(营养成分)。
利用本实施方式的胃瘘用半固态营养剂,能够抑制胃食管反流的发生,因此可以理想地补给能量等,进而能够成为嗜好性优异的食品。
另外,本实施方式的胃瘘用半固态营养剂能够同时补给水分和营养,因此可以根据目的进行各种产品的开发。例如,通过调节水分量,可以制造具有不同口感的胃瘘用半固态营养剂。另外,通过调节热量,可以制造适应要求的胃瘘用半固态营养剂。进而,通过调节pH,可以制造赋予了期望的清凉感的胃瘘用半固态营养剂。
以下给出本发明的胃瘘用半固态营养剂的优选的制造方法的一个例子。
本方式的胃瘘用半固态营养剂可以根据公知的方法进行制造。例如,可通过向经加热的水中添加营养素、琼脂及其他所期望的成分,进行搅拌,由此制造。另外,可以如下制造:准备将琼脂溶解在经加热的水中所得的溶液和将蛋白、糖类、加工淀粉等溶解在温水中所得的溶液,将其他所期望的成分添加到任意溶液中,将2种溶液混合、进行搅拌。
得到的胃瘘用半固态营养剂例如可以在经连续灭菌后填充到容器中进行产品化。作为该连续灭菌的方法,没有特别限定,可以举出超高温瞬时(UHT)灭菌、热水灭菌、分批式灭菌、及它们的组合。上述灭菌优选以短时间进行。通过以短时间进行灭菌,可以抑制胃瘘用半固态营养剂中所含成分的劣化。
本发明的第二个实施方式是向每1个容器中填充了相当于300~400Kcal的本发明的胃瘘用半固态营养剂的、已填充到容器的胃瘘用半固态营养剂。
作为填充该胃瘘用半固态营养剂的容器,没有特别限定,可以使用公知的容器。作为该容器,可以举出利乐包、纸质饮料罐、玻璃容器、金属罐、铝袋、塑料容器等。其中,优选使用塑料容器。
作为上述塑料容器的原料,优选使用聚乙烯(PE)、聚丙烯(PP)、聚氯乙烯(PVC)、聚乙酸乙烯酯(PVAc)、聚碳酸酯(PC)、聚对苯二甲酸丁二醇酯(PBT)、聚对苯二甲酸乙二醇酯(PET)、聚萘二甲酸乙二醇酯(PEN)、乙烯-乙酸乙烯酯共聚物(EVA)、乙烯-α-烯烃共聚物、多氟烃、聚酰亚胺等。
在上述塑料容器中,还可以适当组合下述层:含有聚对苯二甲酸乙二醇酯(PET)、聚萘二甲酸乙二醇酯(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、聚酰胺、聚酯等的气体阻隔性树脂层;铝箔、铝蒸镀膜、氧化硅被膜、氧化铝被膜等气体阻隔性无机层。通过设置该气体阻隔层,能够防止由氧、水蒸气等导致的胃瘘用半固态营养剂的劣化。
另外,上述容器还可以进一步被遮光。通过该遮光,例如能够抑制胃瘘用半固态营养剂中可能含有的维生素A、维生素B2、维生素C、维生素K等因光导致的劣化。
上述容器可以使用市售品,例如,可以使用Soft pouch(株式会社Fujiseal制)、Bottled Pouch(凸版印刷株式会社制)、Supouch(大日本印刷株式会社制)、Cheer Pack(株式会社细川洋行制)等。
实施例
以下,举出实施例具体说明本发明,但本发明并不限于这些实施例。需要说明的是,在实施例中,使用“份”或“%”的表示,只要没有特别说明,则表示“质量份”或“质量%”。
“胃瘘用半固态营养剂的制造”
(实施例1)
向5L的不锈钢桶中投入调合水1200份,在热水浴中加热至80℃以上。接着,添加作为琼脂的Ultra Agar UX30(伊那食品工业株式会社制)20份,使其溶解。将得到的溶液冷却至50~60℃,添加作为蛋白质的WPI895(分离乳清蛋白:Fonterra公司制)140份、和作为糖类的TK-16(糊精:松谷化学工业株式会社制)400份。在该溶液中混合下述分散液,所述分散液是在50℃下将作为脂质的植物油60份、作为乳化剂的甘油脂肪酸酯10份和作为加工淀粉的WMS(乙酰化二淀粉磷酸酯:松谷化学工业株式会社制)35份混合得到的。进而,适当添加以下物质:作为维生素,水溶性维生素混合物0.3份、脂溶性维生素混合物1.5份;作为矿物质,葡糖酸钙20份、氯化镁10份、氯化钾3.2份、氯化钠0.2份、磷酸二氢钠10份、及柠檬酸三钾6份;作为食物纤维,瓜耳胶水解物25份;酵母混合物0.5份;作为酸味剂,柠檬酸25份、苹果酸8份、及乳酸27.3份;抗坏血酸二葡糖苷0.6份;葡糖酸锌0.294份;葡糖酸铜0.029份;香料1.5份,进行搅拌。添加水直至所得混合液变为4000份,溶解分散直至变为均匀的状态。
得到的溶液在经连续灭菌后,将其以每1个200份的方式填充到带塞的铝袋中,在90℃下进行10分钟的容器灭菌处理。在上述容器灭菌处理之后,通过冷却制造袋装的半固态化的胃瘘用半固态营养剂。
(实施例2)
将蛋白质变更为WPC392(浓缩乳清蛋白:Fonterra公司制)150份,除此之外,利用与实施例1同样的方法制造半固态化的胃瘘用半固态营养剂。
(实施例3)
将蛋白质变更为大豆蛋白(Proleena 900)(不二制油株式会社制)140份,除此之外,利用与实施例1同样的方法制造半固态化的胃瘘用半固态营养剂。
以下表1中示出了实施例1~3的胃瘘用半固态营养剂的组成、热量、pH。
(比较例1)
将2000份TM Mini(Terumirumini咖啡味:泰尔茂株式会社制)在40℃的水中加热30分钟后,使20份琼脂分散在2000份水中并煮开,确认了琼脂溶解后,将事先加热了的2000份TM Mini添加到该分散了的含琼脂的溶液2020份中,搅拌30秒,得到混合溶液4020份。之后,用导管式接头注射器(泰尔茂株式会社制)吸取该混合溶液,在4℃下静置12小时,将凝固了的溶液作为比较样品。
“胃瘘用半固态营养剂的评价”
(热量测定)
基于通常的能量换算系数,即,糖类4kcal/g、蛋白质4kcal/g、脂质9kcal/g、及食物纤维2kcal/g,通过下式算出半固态化营养剂的热量。
热量(kcal/g)=糖类(g/g)×4(kcal/g)+蛋白质(g/g)×4(kcal/g)+脂质(g/g)×9(kcal/g)+膳食纤维(g/g)×2(kcal/g)(pH)
使用pH测定仪(METTLER TOLEDO MP220(METTLERTOLEDO公司)测定半固态化营养剂的pH。将其结果示于上述表1。
(性状)
通过目视判断实施例1~3的胃瘘用半固态营养剂及比较样品的性状。将其结果示于上述表1。
(粘度测定)
对于上述实施例1~3的胃瘘用半固态营养剂及比较例中制造的比较样品进行粘度测定。该粘度测定使用以下测定仪器和条件进行。
需要说明的是,将粘度测定的结果示于后述的表2。
测定仪器:B型粘度计
制造商:BROOKFIFLD
型号:DV-II+Pro
测定条件:转速6rpm
测定时间1min
转子No.64
测定温度室温(25℃)
(基于形状变化评价试验的残留率测定)
对于上述实施例1~3的胃瘘用半固态营养剂及比较例中制造的比较样品,进行基于人工胃液及人工肠液中的形状变化评价试验的残留率测定。基于该形状变化评价试验的残留率测定使用以下的测定仪器和条件进行。
(1)人工胃液中的形状变化评价试验
向溶出试验机(富山产业)的烧杯内加入500mL人工胃液(pH1.2关东化学公司制),在37℃下加热30分钟后,分别用注射器向该溶液内注入100g的试样(上述实施例1~3的胃瘘用半固态营养剂及比较例中制造的比较样品)。以溶出试验机的桨不接触试样的方式、在每分钟3转的速度下转动5分钟,然后停止溶出试验机,将溶液与分散于液内的各试样一同置于60目的筛上,将筛上的固态成分作为残渣,测定其重量。算出残渣重量(g)相对于注入于烧杯的量100g的比例(%),作为食块残留率(%)。将其结果示于以下的表2、表3-1及表3-2。
(2)在人工肠液中的形状变化评价试验
向溶出试验机(富山产业)的烧杯内中注入500mL人工肠液(pH6.8关东化学公司制),在37℃下加热30分钟后,分别用注射器向该溶液内中注入100g的试样(上述实施例1~3的胃瘘用半固态营养剂及比较例中制造的比较样品)。以溶出试验机的桨不接触试样的方式、在每分钟65转的速度下转动60分钟,然后停止溶出试验机,将溶液与分散于液内的各试样一同置于60目的筛上,将筛上的固态成分作为残渣,测定其重量。算出残渣重量(g)相对于注入于烧杯的量100g的比例(%),作为食块残留率(%)。将其结果示于以下的表2、表3-1及表3-2。
用图1的照片表示将实施例1的胃瘘用半固态营养剂注入人工肠液中、并且在每分钟65转的速度下转动60分钟后的形状变化评价试验的情况。图1中,左侧的照片表示从溶出试验机的烧杯侧面观察到的状态,右侧的照片表示从溶出试验机的烧杯的上面观察到的状态。
另外,用图2的照片表示将比较例1的比较样品注入人工肠液中、并且在每分钟65转的速度下转动60分钟后的形状变化评价试验的情况。图2中,左侧的照片表示从溶出试验机的烧杯的侧面观察到的状态,右侧的照片表示从溶出试验机的烧杯的上面观察到的状态。
以下的表3-1及表3-2是将上述表2中的实施例1~3的胃瘘用半固态营养剂及比较例中制造的比较样品的各残留率进行作图而得到的图表。
[表3-1]
[表3-2]
由上述图1及2、表2、表3-1、及表3-2确认到本发明的胃瘘用半固态营养剂在肠内的分解性优异。
Claims (6)
1.一种胃瘘用半固态营养剂,其含有7~17质量%的糖类和1.5~6.5质量%的蛋白质,所述胃瘘用半固态营养剂在37℃的人工肠液中以每分钟65转搅拌60分钟后,置于网孔为300μm的筛上,通过测定残渣重量的形状变化评价试验算出的表示所述残渣的比例的食块残留率为20%以下。
2.如权利要求1所述的胃瘘用半固态营养剂,其在25℃下的粘度为10000~40000mPa·s。
3.如权利要求1或2所述的胃瘘用半固态营养剂,其每1g的热量为0.5~0.9kcal。
4.如权利要求1~3中任一项所述的胃瘘用半固态营养剂,其水分量为91~177ml水分/100Kcal。
5.如权利要求1~4中任一项所述的胃瘘用半固态营养剂,其pH为4.0以下。
6.如权利要求1~5中任一项所述的胃瘘用半固态营养剂,其以1∶1.5~1∶0.67的比例含有发酵性食物纤维和非发酵性食物纤维。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2012036788 | 2012-02-22 | ||
JP2012-036788 | 2012-02-22 | ||
PCT/JP2012/067509 WO2013125067A1 (ja) | 2012-02-22 | 2012-07-09 | 胃瘻用半固形栄養剤 |
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