CN101027074B - 复合肠内营养组合物 - Google Patents
复合肠内营养组合物 Download PDFInfo
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- CN101027074B CN101027074B CN2005800319957A CN200580031995A CN101027074B CN 101027074 B CN101027074 B CN 101027074B CN 2005800319957 A CN2005800319957 A CN 2005800319957A CN 200580031995 A CN200580031995 A CN 200580031995A CN 101027074 B CN101027074 B CN 101027074B
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Abstract
本发明提供一种复合肠内营养组合物,它可以发挥改善血清白蛋白值及改善褥疮的效果,含有蛋白质、糖质、脂肪、矿物质、维生素。该复合肠内营养组合物中,锌和铜的质量比为10~25,每100kcal组合物,含有锌1.5mg以上、铜0.075~0.15mg、钠至少185mg、维生素B1至少0.30mg、维生素B2至少0.25mg、蛋白质至少4.0g。优选含有蛋白质至少5.0g、进一步含有维生素B6至少0.30mg、生物素至少1.0μg、维生素B12至少0.20μg、叶酸至少20μg、β-胡罗卜素至少100μg、维生素C至少10mg。进一步,每100kcal组合物中,至少含有脂肪中35重量%的中链脂肪酸油作为脂肪源。组合物优选的粘度为6~18mPa·s(25℃)。
Description
技术领域
本发明涉及一种针对老年人、住院病患者等必需营养补充的人群的,可有效补充蛋白质、脂肪、糖质、维生素、矿物质等的复合肠内营养组合物。
背景技术
近年来,老年住院患者、老年住家疗养患者等人群有营养状态恶化的趋势。在营养缺乏状态中因蛋白质、能量的欠缺综合而产生的营养失调被称为蛋白质/能量营养不良(Protein Energy Malnutrition;PEM),而对于该状态进行高效的营养补充的重要性也逐渐被认识。在平成7~10年的“高齢者の栄養管理サ一ビスに関する研究”(主任研究者:松田朗等99年厚生省报告)中,在作为营养指标的血清白蛋白值为3.5g/dL以下的PEM风险患者中,观察到约4成为老年住院患者,约3成为住家访问患者。由于进食摄取量降低等导致适当的蛋白质或能量的供应不足,引起严重的营养不良状态,结果导致出现免疫力降低引发的感染症、肌肉力量的降低、卧病在床的状态,最终成为导致住医院天数的延长、医疗费用的增高的原因。在卧病在床时多引起褥疮发生,作为与褥疮发生相关的因素,可举出能量不足、蛋白质量摄入不足、体内蛋白质合成障碍、脂肪摄取不良、锌等微量元素缺乏等原因(临床营养:103卷,4号,424-431页,2003年)。另外,据报道与老年人的褥疮发生相关的特征因素为,血管障碍等多种并发症、食欲不振、营养不良引起的免疫机能降低(临床营养:103卷,4号,424-431页,2003年)。
针对于必须进行营养补充的对象人群的、综合的含有蛋白质、脂质、糖质、维生素、矿物质的口服营养组合物已被公开(日本专利第3102645号)。这是一种仅靠其本身便可进行营养管理的营养组合物,其特征为该配方组成中的蛋白质原料中以特定比例含有乳蛋白和大豆蛋白,并以特定比例含有脂质中的ω-3类脂肪酸和ω-6类脂肪酸。另外,由蛋白质、脂质、糖质、乳化剂及水构成的、具有特定的渗透压和氨基酸值的复合肠内营养剂也已被公开(日本特开2004-51494)。
尤其是老年或严重营养不良状态的患者人群的胃容量也不大,其可摄入的食物的量受到限制。因此,亟需发明一种每摄取量对应的热量高、平衡的含有各种营养成分的、且由高浓度的维生素、矿物质等成分构成的肠内营养组合物。而市售有通过每100mL肠内营养组合物可摄取100kcal的产品,预计该需求今后还会继续增长。
但是在目前的情况下,可同时改善作为营养指标的血清白蛋白、适当的维持血中的铜、锌、钠等的浓度、并对褥疮的改善有效果的肠内营养剂还未见报道。另外,从大量配合纯化的高纯度的蛋白质、脂质,并适当的含有用于使生物体内顺利的产生能量的维生素类物质的观点出发,适当的配合有必要成分的复合肠内营养组合物迄今为止尚未出现。特别是如想在大量含有蛋白质的营养组合物中增加钠的含量,迄今为止往往由于会产生蛋白质沉淀(盐析)而受到了限制。但是,老年人多发生低血钠症,因此在高能量复合肠内营养组合物中,同时提高蛋白质含量和钠含量是极为重要的。
专利文献1:日本专利第3102645号公报
专利文献2:日本特开2004-51494公报
发明内容
本发明的目的为提供一种针对老年人、住院病患者此类通过饮食无法摄取足够的营养的人群,可仅通过其即可复合提供所必需的营养的经改善的复合肠内营养组合物。具体而言,本发明提供一种对作为营养指标的血清白蛋白的值的改善及褥疮的改善具有显著效果,并适当的配合有蛋白质、脂肪、糖质、维生素、矿物质、特别是锌和铜的复合肠内营养组合物。进一步提供一种最大限度增加蛋白质配合量,并在不引起蛋白质沉淀的情况下配合有钠,含有大量维生素B1、维生素B2,具有有效的恢复营养状态、预防营养不良状态、改善褥疮及预防效果的新型复合肠内营养组合物。
本发明的复合肠内组合物含有蛋白质、糖质、脂肪、矿物质、维生素,通过综合性组合下述三个特征以实现所期望的目标。
(1)每100kcal组合物,铜的含量为0.15mg以下,锌和铜的质量比为10~25,优选为13~20,特别优选为15~18。此时锌含量为15mg以上,铜含量为0.075~0.15mg是优选的。这是基于铜的含量高时将阻碍锌的吸收的知识而制定的特征。
(2)每100kcal组合物,钠的含量为185mg以上,优选含有蛋白质4.0g以上,更优选含有5.0g以上。这是由于为了防止钠的缺乏,必须含有高浓度的钠。特别是由于如此高浓的钠,在蛋白质浓度很高的时候,使用以磷酸钠和柠檬酸钠等为主的钠源,可防止因盐析引起的蛋白质沉淀的障碍。
(3)每100kcal组合物至少含有0.3mg维生素B1及0.25mg维生素B2。这是因为通过加入高浓度的由糖质生产能量所必需的维生素B1、和由脂质生产能量所必需的维生素B2,可有效的进行能量的生产。
进一步详细说明,每100kcal组合物优选锌的含量为1.5~3.0mg,铜含量为0.075~0.15mg,钠的含量为185mg~385mg。进一步优选的情况为,每100kcal组合物优选锌的含量为1.8~3.0mg,铜含量为0.09~0.12mg,钠的含量为200~385mg。
为了促进糖质、脂质在体内的燃烧,提高迄今为止已知的维生素的使用量,每100kcal组合物优选含有0.4~2mg维生素B1及0.25~2.0mg维生素B2。作为其他维生素,至少配合0.30mg维生素B6、优选0.5~2.0mg,至少配合1.0μg生物素、优选1.0~10μg。进一步每100kcal添加0.20~0.70μg维生素B12、20~80μg叶酸、100~450μg β-胡萝卜素、10~70mg维生素C可获得更好的效果。
本发明的复合肠内营养组合物的能量源为蛋白质、糖质、脂质。由蛋白质、糖质、脂质所提供的能量的比例优选在蛋白质10~40%,糖质40~80%,脂质10~40%的范围内调节。
每100kcal组合物优选含有4.0g以上蛋白质,更优选含有5.0g以上蛋白质。可利用动物性蛋白质、植物性蛋白质等任一种蛋白质为蛋白质源,混合使用动物性蛋白质和植物性蛋白质时的比例优选为4∶1至1∶4。蛋白质中优选含有谷氨酰胺或谷氨酰胺肽、及大豆蛋白质或其水解物。进一步,每100kcal组合物,蛋白质中的总谷氨酰胺至少为0.6g。特别优选的情况为谷氨酰胺或谷氨酰胺肽、及大豆蛋白质或其水解物的比例为4∶1至1∶4。
可使用动物性及植物性的可吸收的脂质作为脂肪源。优选脂肪中至少含有35重量%的中链脂肪酸油,且脂肪中的ω-3类脂肪酸∶ω-6类脂肪酸的比例为1∶10至1∶1。进一步优选的情况是,脂肪中含有40~65重量%的中链脂肪酸三甘油酯,且脂肪中的ω-3类脂肪酸∶ω-6类脂肪酸的比例为1∶4至1∶1。中链脂肪酸为碳原子数6~12的脂肪酸,消化吸收快,因此适用于老年人、住院患者的治疗食物。
可单独或组合使用糊精、寡糖、蔗糖、葡萄糖、果糖等作为糖质源。
除上述成分外,根据需要添加作为必需氨基酸的亮氨酸、异亮氨酸、缬氨酸、丝氨酸、赖氨酸、甲硫氨酸、苯丙氨酸、色氨酸。作为矿物质,除了上面所述的钠、锌、铜,还可根据需要添加钙、铁、磷、镁、钾、碘、锰、硒、铬、钼等。
本发明的复合肠内营养组合物,可口服或经管道给药。因此,优选为液态流动性良好的液态组合物,此时的组合物的粘度优选为6~18mPa·s(25℃)的范围内。
本发明的复合肠内营养组合物,对于蛋白质/能量营养不良(PEM)的人的治疗或预防、血清白蛋白值的改善、褥疮的改善、白蛋白-球蛋白比的改善、钠含量的降低及氯(クロ一ル)含量的改善、血红蛋白的值的改善、血细胞比容值的改善、血清中的锌含量的增加、末梢淋巴细胞数量的增加等具有显著的效果。
具体实施方式
本发明的复合肠内营养组合物使用纯化的动物性蛋白质、植物性蛋白质或它们的组合作为蛋白质源。特别对于患有脑血管障碍的人或高血脂症的人,合理考虑作为营养素平衡之一的动物性蛋白质和植物性蛋白质的比例进行摄取对于防止动脉硬化或血中脂肪的降低是重要的,在本发明的复合肠内营养组合物中,动物性蛋白质和植物性蛋白质的比例推荐为1∶4至4∶1。另外,还确认了大量含有作为免疫营养材料而备受瞩目的谷氨酰胺时患者的全身和肠道免疫状态良好,根据不同情况的人所需,推荐配合谷氨酰胺或由小麦谷蛋白水解而来的谷氨酰胺肽、丙氨酰谷氨酰胺、甘氨酰谷氨酰胺等纯化的谷氨酰胺。本发明的组合物中的总谷氨酰胺量优选每100kcal为0.6g以上。
本发明的复合营养组合物中使用的脂肪只要为人可摄取的脂肪源即可。特别在需要高效率的提供能量的时候,推荐具有可与葡萄糖相匹敌的肠内的吸收速度的、能量产生率大的中链脂肪酸三甘油酯、在结构中含有中链脂肪酸三甘油酯或中链脂肪酸的脂肪。另外,含有具有抗炎作用的二十碳五烯酸或α亚麻酸等ω-3类脂肪酸,对于患有炎症的患者或必须预防炎症的患者等必需这些脂肪的人群的积极的补充是必要的。本发明的复合肠内营养组合物中,特别优选含有总脂肪的35重量%以上的中链脂肪酸油,且脂肪中ω-3类脂肪酸∶ω-6类脂肪酸的比例为1∶10至1∶1。
矿物质的必须的含量原则上以第6次修订日本人的营养需要量为基准制定。但是,老年人由于摄取量低因而具有易发生低血钠症的问题,因此本发明的复合肠内营养组合物中强化了钠。钠源只要为人体可摄取的或可给药的物质即可并不限制其种类,但为了不发生因盐析导致的蛋白质沉淀,采用柠檬酸钠、磷酸钠为主要的钠源。本发明中,每100kcal钠的含量为185mg以上时显示有效性,特别在每100kcal为200~385mg时具有显著的效果。
与生物体的多种酶的功能、结构关系密切的锌,在营养状态低的人群中容易缺乏。补充锌使血中的锌浓度上升,特别对于具有褥疮等创伤的患者或具有此类风险的人群是有用的。另外,由于锌的吸收与2价的铜离子相互竞争,有必要配合铜和锌的配合比例与铜的含量以使其对锌的吸收有利。在本发明的复合肠内营养组合物中,每100kcal至少配合1.5mg、优选1.5~3.0mg的锌,配合0.075~0.15mg的铜,锌和铜的质量比为10~25,优选为13~20,特别优选为15~18,最优选为15,如此可获得促进褥疮等创伤的治疗的效果。根据第6次修订日本人的营养需要量,锌和铜的质量比因年龄和性别而异,考虑到在最高的30~49岁等男性的情况下约为6.7,在老年人中男性约为6.3,女性约为6.4,在营养不良状态下锌不足时设定锌和铜的含量比通常情况下更高是重要的。进一步,根据必须进行营养补充的人的炎症状态,在本品中添加每100kcal4.5~18μg左右的具有抗氧化作用的微量元素的硒是有用的。
维生素作为在能量的产生、蛋白质代谢、皮肤粘膜的生理功能保持等多种生物体活动中所必需的辅酶是极为重要的。但是,对于营养不良状态的人应配合的量的研究迄今为止仍不充分。在本发明的复合肠内营养组合物中,每100kcal至少含有0.3mg维生素B1,至少含有0.25mg维生素B2、至少含有0.3mg维生素B3,至少含有1.0μg生物素。进一步,最佳效果的配合量为每100kcal含有维生素B10.4~2.0mg,B2为0.25~2.0mg,维生素B6为0.5~2.0mg,生物素为1.0~10μg。进一步,其他的维生素的添加对于营养状态的改善、维持、营养不良状态的预防、褥疮的治疗或预防、贫血的治疗或预防是有效的。本发明的复合肠内营养组合物中,推荐配合具有抗炎作用、抗氧化作用、褥疮防治作用的维生素B12、叶酸、β-胡萝卜素、维生素C等。具体而言,每100kcal复合肠内营养组合物,配合例如0.20~0.7μg维生素B12、20~80μg叶酸、100~450μgβ-胡萝卜素、10~70mg维生素C。上述所有的配合用维生素只要为人可摄取的维生素可来源于任意原料,其来源并无限定。
本发明的复合肠内营养组合物中,为了使其易于口服,可加入适当的香料、阿司帕坦等无热量甜味剂。进一步,只要在不妨碍本发明的复合肠内营养组合物的功能的范围内,还可根据需要添加用于排便促进的难消化性食物纤维等成分、根据情况进行口服的医药品等。
营养不良状态的人,在难以口服摄取时多采用管子经过管道实施主动的营养补充。但是,迄今为止,如本发明配合了如此高比例的蛋白质,进一步充分添加矿物质时将产生沉淀,液体的粘度增高而不可能经管道摄取。成分的配合比例、制造方法的研究的结果为,完成了低粘度的液态复合肠内营养组合物,首次使经管道摄取变为可能。即该组合物的粘度在6~18mPa·s(25℃)的范围内,流动性非常优秀。
本发明的复合肠内营养组合物可提供给营养状态低下的人,对受到例如蛋白质/能量营养不良(PEM)、低白蛋白血症、低钠血症、锌缺乏状态、贫血、血红蛋白的值及血细胞比容值降低、褥疮或创伤、免疫力降低等及病困扰的人群特别有效。因此,对于迄今为止没有有效的营养组合物的人们来说本发明的复合肠内营养组合物具有很大贡献。
实施例
[实施例1]
复合肠内营养组合物的制备(组合物1)
详细研究对于营养不良状态的最佳营养效果,制作了营养素组成[表1]。用于将其具体化的液态物质的原料配方表在[表2]中表示。为了制成乳化稳定性优良,不易引起蛋白质等沉淀的组合物,根据原料配方表对钠原料和蛋白质原料及乳化剂进行配合,通过以500~1000kg/cm2的高压乳化机的压力进行数次乳化步骤,制备液态复合肠内营养组合物。也即,使用高压乳化机对原料和水反复进行高压乳化,配制为优良的1kcal/ml的浓度的乳化液。使动物性蛋白质和植物性蛋白质的比例为1∶1.5。另外,谷氨酰胺肽和大豆蛋白质或其水解物的比例为1∶1.4,而在脂肪酸组成中以ω-3类脂肪酸∶ω-6类脂肪酸的比例为1∶3进行配合。使用普通的填充机将其填充在铝制袋中,将其放入甑馏灭菌机中,在通常条件下实施灭菌。该液体放置1年后全部成分仍然稳定,粘度为9mPa·s(25℃)。
表1:营养素组成1
表2:原料配方1
配合成分 | 配合量(100mL中) | 单位 |
酪蛋白钠 | 3.878 | g |
谷氨酰胺肽(小麦谷蛋白分解物) | 1.666 | g |
粉末大豆蛋白质 | 1.109 | g |
L-赖氨酸盐酸盐 | 0.030 | g |
L-色氨酸 | 0.010 | g |
中链三甘油酯 | 1.390 | g |
食用油脂及纯化鱼油 | 1.055 | g |
麦芽糊精、食物纤维、寡糖 | 14.131 | g |
柠檬酸钠 | 0.413 | g |
磷酸氢二钠 | 0.259 | g |
氯化镁 | 0.223 | g |
柠檬酸钾 | 0.170 | g |
配合成分 | 配合量(100mL中) | 单位 |
氯化钙 | 0.119 | g |
碳酸钾 | 0.200 | g |
碳酸钙 | 0.076 | g |
乳酸钙 | 0.019 | g |
柠檬酸亚铁钠 | 9.545 | mg |
微量元素酵母MIX(含有锌、铜、锰、铬、钼、硒、碘) | 55.748 | mg |
L-抗坏血酸钠 | 0.072 | g |
维生素E | 5.751 | mg |
β-胡萝卜素制剂 | 1.300 | mg |
甲基萘醌粉末 | 2.751 | mg |
烟酰胺 | 1.690 | mg |
泛酸钙 | 1.794 | mg |
盐酸硫胺素 | 0.960 | mg |
维生素A脂肪酸酯制剂 | 1.052 | mg |
维生素B6盐酸盐 | 0.728 | mg |
核黄素5’-磷酸酯钠 | 0.449 | mg |
维生素D3 | 0.129 | mg |
叶酸 | 0.063 | mg |
生物素 | 2.551 | μg |
配合成分 | 配合量(100mL中) | 单位 |
维生素B12 | 0.550 | μg |
乳化剂 | 0.335 | g |
甜味剂 | 7.350 | mg |
香料 | 0.103 | g |
[实施例2]
复合肠内营养组合物的制备(组合物2)
按照与实施例1同样的方法制定[表3]中所示的营养组成。用于将其具体化的液态物质的原料配方表在[表4]中表示。按照与实施例1同样的方法,组合钠原料和蛋白质原料及乳化剂的配合量,进而通过500~1000kg/cm2的高压乳化剂的压力进行数次乳化步骤,制备液态复合肠内营养组合物。也即,使用高压乳化机对原料和水反复进行高压乳化,配制为优良的1kcal/ml的浓度的乳化液。使动物性蛋白质和植物性蛋白质的比例为1∶2。另外,谷氨酰胺肽和大豆蛋白质水解物的比例为3∶1,而在脂肪酸组成中以ω-3类脂肪酸∶ω-6类脂肪酸的比例为1∶1进行配合。使用普通的填充机将其填充在铝制袋中,将其放入甑馏灭菌机中,在通常条件下实施灭菌。该液体放置1年后全部成分仍然稳定,粘度为1 6mPa·s(25℃)。
表3:营养素组成2
表4:原料配方2
配合成分 | 配合量(100mL中) | 单位 |
酪蛋白钠 | 2.301 | g |
谷氨酰胺肽(小麦谷蛋白分解物) | 3.876 | g |
粉末大豆蛋白质 | 1.321 | g |
L-赖氨酸盐酸盐 | 0.030 | g |
L-色氨酸 | 0.010 | g |
中链三甘油酯 | 1.800 | g |
食用油脂及纯化鱼油 | 0.980 | g |
麦芽糊精、食物纤维、寡糖 | 14.131 | g |
配合成分 | 配合量(100mL中) | 单位 |
柠檬酸钠 | 0.620 | g |
磷酸氢二钠 | 0.388 | g |
氯化镁 | 0.223 | g |
柠檬酸钾 | 0.170 | g |
氯化钙 | 0.119 | g |
氢氧化钠 | 0.084 | g |
碳酸钾 | 0.200 | g |
碳酸钙制剂 | 0.076 | g |
乳酸钙 | 0.019 | g |
柠檬酸亚铁钠 | 14.317 | mg |
微量元素酵母MIX(含有锌、铜、锰、铬、钼、硒、碘) | 78.111 | mg |
L-抗坏血酸钠 | 0.126 | g |
维生素E | 5.751 | mg |
β-胡萝卜素制剂 | 1.625 | mg |
甲基萘醌粉末 | 2.751 | mg |
烟酰胺 | 1.690 | mg |
泛酸钙 | 1.794 | mg |
盐酸硫胺素 | 3.168 | mg |
维生素A脂肪酸酯制剂 | 1.052 | mg |
配合成分 | 配合量(100mL中) | 单位 |
维生素B6盐酸盐 | 0.728 | mg |
核黄素5’-磷酸酯钠 | 0.808 | mg |
维生素D3 | 0.129 | mg |
叶酸 | 0.084 | mg |
生物素 | 8.498 | μg |
维生素B12 | 0.550 | μg |
乳化剂 | 0.335 | g |
甜味剂 | 7.350 | mg |
pH调节剂 | 适量 | |
香料 | 0.103 | g |
[实施例3]
复合肠内营养组合物的制备(组合物3)
按照与实施例1同样的方法制定[表5]中所示的营养组成。用于将其具体化的液态物质的原料配方表在[表6]中表示。按照与实施例1同样的方法,组合钠原料和蛋白质原料及乳化剂,进而通过500~1000kg/cm2的高压乳化剂的压力进行数次乳化步骤,制备液态复合肠内营养组合物。也即,使用高压乳化机对原料和水反复进行高压乳化,配制为优良的1kcal/ml的浓度的乳化液。使用普通的填充机将其填充在铝制袋中,将其放入甑馏灭菌机中,在通常条件下实施灭菌。该液体放置1年后全部成分仍然稳定,粘度为10mPa·s(25℃)。
表5:营养素组成3
表6:原料配方3
配合成分 | 配合量(100mL中) | 单位 |
酪蛋白钠 | 3.767 | g |
谷氨酰胺肽(Ala-Gln) | 0.908 | g |
粉末大豆蛋白质 | 1.081 | g |
L-赖氨酸盐酸盐 | 0.030 | g |
L-色氨酸 | 0.010 | g |
配合成分 | 配合量(100mL中) | 单位 |
中链三甘油酯 | 0.97 | g |
食用油脂及纯化鱼油 | 1.810 | g |
麦芽糊精、食物纤维、寡糖 | 14.131 | g |
柠檬酸钠 | 0.383 | g |
磷酸氢二钠 | 0.240 | g |
氯化镁 | 0.223 | g |
柠檬酸钾 | 0.170 | g |
氯化钙 | 0.119 | g |
碳酸钾 | 0.200 | g |
碳酸钙 | 0.076 | g |
乳酸钙 | 0.019 | g |
柠檬酸亚铁钠 | 8.859 | mg |
微量元素酵母MIX(含有锌、铜、锰、铬、钼、硒、碘) | 52.111 | mg |
L-抗坏血酸钠 | 0.0216 | g |
维生素E | 5.751 | mg |
β-胡萝卜素制剂 | 0.379 | mg |
甲基萘醌粉末 | 2.751 | mg |
烟酰胺 | 1.690 | mg |
泛酸钙 | 1.794 | mg |
配合成分 | 配合量(100mL中) | 单位 |
盐酸硫胺素 | 0.480 | mg |
维生素A脂肪酸酯制剂 | 1.052 | mg |
维生素B6盐酸盐 | 0.606 | mg |
核黄素5’-磷酸酯钠 | 0.312 | mg |
维生素D3 | 0.129 | mg |
叶酸 | 0.025 | mg |
生物素 | 0.849 | μg |
维生素B12 | 0.550 | μg |
乳化剂 | 0.330 | g |
甜味剂 | 7.350 | mg |
香料 | 0.103 | g |
[实施例4]
复合肠内营养组合物的制备(组合物4)
按照与实施例1同样的方法制定[表7]中所示的营养组成。用于将其具体化的液态物质的原料配方表在[表8]中表示。按照与实施例1同样的方法,组合钠原料和蛋白质原料及乳化剂,进而通过500~1000kg/cm2的高压乳化剂的压力进行数次乳化步骤,制备液态复合肠内营养组合物。也即,使用高压乳化机对原料和水反复进行高压乳化,配制为优良的1kcal/ml的浓度的乳化液。使用普通的填充机将其填充在铝制袋中,将其放入甑馏灭菌机中,在通常条件下实施灭菌。该液体放置1年后全部成分仍然稳定,粘度为8mPa·s(25℃)。
表7:营养素组成4
表8:原料配方4
配合成分 | 配合量(100mL中) | 单位 |
酪蛋白钠 | 3.878 | g |
谷氨酰胺肽(小麦谷蛋白分解物) | 1.666 | g |
配合成分 | 配合量(100mL中) | 单位 |
粉末大豆蛋白质 | 1.109 | g |
L-赖氨酸盐酸盐 | 0.030 | g |
L-色氨酸 | 0.010 | g |
中链三甘油酯 | 1.390 | g |
食用油脂及纯化鱼油 | 1.055 | g |
麦芽糊精、食物纤维、寡糖 | 14.131 | g |
柠檬酸钠 | 0.413 | g |
磷酸氢二钠(结晶) | 0.259 | g |
氯化镁 | 0.223 | g |
柠檬酸钾 | 0.170 | g |
氯化钙 | 0.119 | g |
碳酸钾 | 0.200 | g |
碳酸钙制剂 | 0.076 | g |
乳酸钙 | 0.019 | g |
柠檬酸亚铁钠 | 9.545 | mg |
氯化钠 | 114.50 | mg |
微量元素酵母MIX(含有锌、铜、锰、铬、钼、硒、碘) | 50.051 | mg |
L-抗坏血酸钠 | 0.072 | g |
维生素E | 5.751 | mg |
配合成分 | 配合量(100mL中) | 单位 |
β-胡萝卜素制剂 | 1.027 | mg |
甲基萘醌粉末 | 2.751 | mg |
烟酰胺 | 1.690 | mg |
泛酸钙 | 1.794 | mg |
盐酸硫胺素 | 0.640 | mg |
维生素A脂肪酸酯制剂 | 1.052 | mg |
维生素B6盐酸盐 | 0.728 | mg |
核黄素5’-磷酸酯钠 | 0.449 | mg |
维生素D3 | 0.129 | mg |
叶酸 | 0.063 | mg |
生物素 | 2.551 | μg |
维生素B12 | 0.550 | μg |
乳化剂 | 0.335 | g |
甜味剂 | 7.350 | mg |
香料 | 0.103 | g |
[有效性试验1]
针对于人体的实验
使用实施例1中制备的本发明的液态复合肠内营养组合物(本发明品),对老年PEM患者的营养状态的改善效果进行检验。对象为正在住院的经管道营养方式进行营养管理的老年人,白蛋白值为3.5g/dL以下的PEM患者9名,平均年龄81.3±9.9岁。给药时间为8周。在开始进行本发明产品的给药之前,以市售的营养制品A、B等多种产品进行了给药。市售的营养品A、B等和本发明产品的各营养品的给药量和充足率在表9中表示。由本发明产品的给药带来的能量(873±124kcal/日),与在其之前的市售的营养制品A、B等的给药带来的平均能量(863±134kcal/日)相同。确认了市售的营养制品A、B等给药时与本发明产品给药时的营养状态。在早晨进行采血,在开始前、4周、8周后进行血液学检查、血液生化检查的测定。
表9.营养素给药量和充足率
*:p<0.05 **:p<0.01 ***:p<0.001
需要量为第六次修订日本人的营养需要量 70岁以上的基准值
充足率按照需要量的男女负重平均值为基准求得
该试验结果表明,在PEM状态下的白蛋白含量为3.5g/dL以下的患者,由给予本发明产品开始前的白蛋白含量3.09±0.28g/dL到给药开始8周后显著上升至3.33±0.31g/dL。另外,白蛋白-球蛋白比也由开始前的0.8±0.2显著上升至给药开始8周后的0.9±0.2。而钠浓度也由给药开始前的138±2.6mmol/L变为给药开始8周后的142±5.6mmol/L,氯浓度也由给药开始前的102±4.1mmol/L变为给药开始8周后的107±4.7mmol/L,血红蛋白的浓度由给药开始前的12.0±1.5g/dL变为给药开始8周后的12.8±1.2g/dL,血细胞比容值由给药开始前的35.4±4.3%变为给药开始8周后的38.1±3.7%,均有了显著的改善。另外,血中的锌浓度由给药开始前的64±4μg/dL变为给药开始8周后的77±5μg/dL,有了显著的上升。由于锌的血中基准值的下限为66μg/dL(临床检查项辞典,医齿药出版株式会社),即使在血中呈低锌浓度的患者群中也可获得恢复至正常值的效果,证明了本发明产品的锌配合量为适当的。另外,患有褥疮的患者的褥疮大小在给予本产品后其数值有明显降低。而作为免疫指标的末梢淋巴细胞在给药后也有上升。在研究期间中,在9名研究对象中,仅发现1例以止泻剂给药即可止泻程度的轻度的下泻,发生率为11%,整体为稳定状态,未发现健康方面的特别问题。下泻为肠内营养疗法中的很大的副作用,严重时可导致肠内营养疗法的营养补充的终止。考虑到市售营养剂C的下泻发生率为34%(该产品的附加文件中有记载),市售营养剂D的下泻发生率为17%(该产品的附加文件中有记载),证明本发明产品优于上述产品。
由上述结果可知,本发明的复合肠内营养组合物含有对改善营养不良状态的人的营养状态适当的蛋白质的量。而本发明的复合肠内营养组合物还可补充能量代谢中必需的充分的各种维生素类、微量元素,进而以钠或锌为代表的电解质、微量元素也变得正常,而无需在目前的营养剂中添加大量的食盐。本次使用的本发明的复合肠内营养组合物,即使以1天给药量为平均873kcal,也可补充充足的蛋白质、维生素类、食盐、微量元素,在营养不良、低白蛋白血症或贫血、褥疮的改善中非常有效。
在实施例2、3及4种配制的营养组合物2、3及4中也确认了各指标的有效性。
[有效性试验2]
对于人褥疮的治疗效果
使用实施例1中配制的本发明的液态复合肠内营养组合物(本发明产品),验证对于难治性褥疮发生的老年患者的褥疮改善效果。患者为正在住院的95岁的超高龄老人,为需要辅助的状态。从营养评价记录的平成14年7月的白蛋白3.5mg/dL以下起连续2年以上呈营养不良状态。病例中诊断为闭塞性动脉硬化症(双下肢特别是右肢),褥疮在右边第1趾根部发病,由市售肠内营养制品A进行了营养补充。是院内会诊得出结论经继续处置难以使褥疮治愈的患者。对该血液循环不良为基础病症的难治性老年褥疮患者,给予市售肠内营养制品A和同热量的本发明产品,测定褥疮的治愈情况。市售肠内营养制品A和本发明的产品的营养素给予量在[表10]中表示。以市售肠内营养制品A给药时和以本发明产品给药时的能量相同。
表10.营养素给药量
褥疮的大小在给予本发明产品前为长4cm×宽4cm的椭圆形,在给药后2周减小至长3cm×宽3cm,可见明显的治疗效果。另外,观察褥疮的外观,可见到在给药前可观察到黄色的柔软的坏死组织,肉芽的长出少,而市售的营养制品A未观察到外观有任何改善。本发明产品给药后良性肉芽的形成有明显增加,褥疮的周围部分可见由粉红色变为白色的改善。如上所述在95岁高龄的营养不良状态的褥疮患者中,本发明产品的给药开始后2周,确认了明确的对于褥疮的治疗效果,也说明本发明产品的组成比率对人的褥疮改善是有效的。
进一步,作为营养评价的重要项目的白蛋白,在市售肠内营养制品A给药时为3.0mg/dL,在本发明产品给药后上升至3.3mg/dL,确认有营养的改善。
综上所述,证明本发明产品的锌和铜的含量及其比率,及产生能量的重要因子的维生素B族的量、蛋白质的量,对治愈创伤是有效的。
产业实用性
本发明的复合肠内营养组合物,具有对于蛋白质/能量营养不良(PEM)的人群的治疗或预防的优秀的效果,对于作为营养指标的血清白蛋白值的改善、褥疮的改善、白蛋白-球蛋白比的改善、钠含量的降低及氯含量的改善、血红蛋白的值的改善、血细胞比容值的改善、血清中的锌含量的增加、末梢淋巴细胞数量的增加等可发挥显著的效果。因此,本发明的组合物,可用于特别是低白蛋白血症的治疗或预防,褥疮或创伤的治疗、预防。另外,本发明的组合物含有高浓度的钠,可用于治疗或预防低钠血症。而且,本发明的组合物还含有高浓度的锌,可用于治疗或预防锌缺乏状态的患者。另外,本发明的组合物,可用于改善血红蛋白值及血细胞比容值及防止其降低。
Claims (18)
1.复合肠内营养组合物,该组合物含有选自酪蛋白钠、谷氨酰胺肽和大豆蛋白质或其水解物的蛋白质、糖质、含有中链脂肪酸三甘油酯的脂肪、矿物质、维生素,其特征为:在每100kcal的该组合物中铜的含量为0.075~0.15mg,锌/铜的质量比为10/1~25/1,钠含量为185~385mg,维生素B1含量为0.30~2.0mg,维生素B2含量为0.25~2.0mg。
2.如权利要求1所述的复合肠内营养组合物,每100kcal该组合物中蛋白质的含量为4.0~6.0g。
3.如权利要求2所述的复合肠内营养组合物,每100kcal该组合物中蛋白质的含量为5.0~6.0g。
4.如权利要求1~3中任一项所述的复合肠内营养组合物,每100kcal该组合物中锌的含量为1.5~3.0mg,铜的含量为0.075~0.15mg。
5.如权利要求1~3中任一项所述的复合肠内营养组合物,每100kcal该组合物中锌的含量为1.5~3.0mg,铜的含量为0.075~0.15mg,钠含量为185~385mg,维生素B 1含量为0.4~2.0mg,维生素B2含量为0.25~2.0mg,锌/铜的质量比为10/1~20/1。
6.如权利要求1~3中任一项所述的复合肠内营养组合物,锌/铜的质量比为13/1~20/1。
7.如权利要求1~3中任一项所述的复合肠内营养组合物,锌/铜的质量比为15/1~18/1。
8.如权利要求1~3中任一项所述的复合肠内营养组合物,每100kcal该组合物中锌的含量为1.8~3.0mg,铜的含量为0.09~0.12mg,钠含量为200~385mg。
9.如权利要求1~3中任一项所述的复合肠内营养组合物,每100kcal该组合物中维生素B6的含量为0.3~2.0mg,生物素的含量为1.0~10μg。
10.如权利要求1~3中任一项所述的复合肠内营养组合物,每100kcal该组合物中维生素B12的含量为0.20~0.70μg,叶酸的含量为20~80μg,β-胡萝卜素的含量为100~450μg,维生素C的含量为10~70mg。
11.如权利要求1~3中任一项所述的复合肠内营养组合物,每100kcal该组合物中硒的含量为4.5~18μg。
12.如权利要求1~3中任一项所述的复合肠内营养组合物,由酪蛋白钠构成的动物性蛋白质与选自谷氨酰胺肽和大豆蛋白质或其水解物的植物性蛋白质的比例为4∶1~1∶4。
13.如权利要求1~3中的任一项所述的复合肠内营养组合物,含有谷氨酰胺肽、和大豆蛋白质或其水解物作为蛋白质。
14.如权利要求1所述的复合肠内营养组合物,每100kcal该组合物中,蛋白质中总的谷氨酰胺为0.6~1.1g。
15.如权利要求13或14所述的复合肠内营养组合物,谷氨酰胺肽与大豆蛋白质或其水解物的比例为4∶1~1∶4。
16.如权利要求1~3中任一项所述的复合肠内营养组合物,其中,脂肪中至少含有35重量%的中链脂肪酸三甘油酯作为脂肪源,且脂肪中的ω-3类脂肪酸∶ω-6类脂肪酸为1∶10~1∶1。
17.如权利要求16所述的复合肠内营养组合物,中链脂肪酸三甘油酯在脂肪中占40~65重量%,且脂肪中的ω-3类脂肪酸∶ω-6类脂肪酸为1∶4~1∶1。
18.如权利要求1~3中任一项所述的复合肠内营养组合物,该组合物的25℃粘度在6~18mPa·s的范围内。
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KR101075816B1 (ko) | 2011-10-25 |
CN101027074A (zh) | 2007-08-29 |
KR20070054739A (ko) | 2007-05-29 |
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