CN109090580A - 一种用于肿瘤患者的特定全营养配方食品及其制备方法 - Google Patents
一种用于肿瘤患者的特定全营养配方食品及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种用于肿瘤患者的特定全营养配方食品及其制备方法。按所述特定全营养配方食品1000ml计，所述营养素包含：蛋白质55‑90g、脂肪53‑71g、碳水化合物95‑125g、膳食纤维9‑16g、库拉索芦荟粉8‑12g、维生素0.8‑1.5g、矿物质10‑19g、水650‑750g；本发明通过合理的原料配比和使用，提供一种符合中国人饮食习惯、适合肿瘤患者的高脂肪、高蛋白、低碳水化合物的特定全营养配方食品。配方中包含人体所需的7大营养素，同时含有能够增强机体免疫力的植物甾醇酯、库拉索芦荟粉、谷氨酰胺和精氨酸。
Description
技术领域
本发明属于特殊食品技术领域，特别涉及一种用于肿瘤患者的特定全营养配方食品及其制备方法。
技术背景
肿瘤是一种消耗性疾病，患者因机体组织贮存的脂肪迅速丢失，造成营养不良，营养不良是造成肿瘤患者死亡的独立危险因子。据报道，门诊和住院肿瘤患者的营养不良发生率分别为32.0％～34％，47.7％～49.0％，而恶性或晚期肿瘤患者的营养不良比例高达68.0％～80.5％。严重的营养不良造成患者生活质量下降、器官功能障碍和并发症增加，并威胁生命。
在西方发达国家，营养治疗已有30多年的历史，是治疗体系中的重要组成部分，营养治疗决定着最终的治疗效果。因此，营养治疗，特别是肠内营养治疗对肿瘤患者的综合治疗起到很重要的作用。研究认为，人体的免疫力和肿瘤的生物学特性是决定肿瘤预后的主要因素。
特定全营养配方食品(Foods for Special Medical Purpose，FSMP)，简称特医食品，是为了满足进食受限、消化吸收障碍、代谢紊乱或特定疾病状态人群对营养素或膳食的特殊需要，专门加工配制而成的配方食品。市场上现有的为肿瘤患者提供营养支持的产品大多是保健食品或普通食品、或是营养科自行配制的营养餐，其多是将具有抗肿瘤功能、提高免疫力的多种活性物质或药食同源的其他配料经简单混合制得；而目前国内获得药字号批文的肠内营养乳剂仅有6种，市场上在售的“安素”、“能全力”、“瑞素”、“百普素”、“力衡全”、“佳维体”等系列肠内营养制剂，但普遍适用于有胃肠道功能的营养不良或摄入障碍的患者，特别适用于肿瘤患者的肠内营养制剂种类较少，而满足《特殊医学用途食品配方通则》的产品还未上市。
发明内容
针对上述问题，本发明提供了一种用于肿瘤患者的特定全营养配方食品及其制备方法，符合《特殊医学用途配方食品注册申请材料项目与要求(试行)》中明确指出“不得添加标准中规定的营养素和可选择性成分以外的其他生物活性物质”，即，药食同源、具有生物活性的原料不能用于特殊医学用途配方食品的规定，并且在进行配方设计、原料选择时均严格遵循《特殊医学用途配方食品通则》(GB29922)，选择普通食品原料、符合GB14880《食品营养强化剂使用卫生标准》、GB2760《食品添加剂使用标准》中规定的原辅料，同时根据肿瘤患者的代谢和营养需求、病理生理特征，通过对不同原料的配合使用，进行营养素配比，开发出一种符合中国人饮食习惯、适合肿瘤患者的特定全营养配方食品，能为肿瘤患者提供全面且均衡的营养，提高其免疫力，有效的改善预后，提高患者生存质量，用于肿瘤辅助治疗。
本发明的上述目的是通过以下技术方案实现的：
一种用于肿瘤患者的特定全营养配方食品，所述特定全营养配方食品1000ml计，包含：蛋白质55-90g、脂肪53-71g、碳水化合物95-125g、膳食纤维9-16g、库拉索芦荟粉8-12g、维生素0.8-1.5g、矿物质10-19g、水650-750g，其中：
所述蛋白质包含豌豆蛋白11.5-19g、大豆分离蛋白11.5-19g、小麦低聚肽23-39g；
所述脂肪包含低芥酸菜籽油25-33g、中链甘油三酯25-33g、植物甾醇酯1.0-1.5g、鱼油 1.2-1.6g；
所述碳水化合物包含麦芽糊精95-125g；
所述膳食纤维包含大豆纤维至少5.6g和低聚果糖至少3.0g；
所述维生素包含维生素A3-5.6mg、维生素C 405-515mg、维生素D3 13-21μg、维生素E 112-170mg、维生素K1 69-127μg、维生素B1 2.9-6.0mg、维生素B2 2.0-3.7mg、VB6 2.7-5.3mg、泛酸7.7-15.4mg、生物素5.7-9.3mg、叶酸4.3-6.3mg、烟酰胺9.7-18.7mg、维生素B123.7-5.3μg、胆碱296-450mg；
所述矿物质包含一水合柠檬酸钾3.98-5.65g、柠檬酸2.3-3.3g、二水合柠檬酸钠0.72-1.16g、氯化钙0.42-0.76g、磷酸氢二钾0.52-0.79g、磷酸氢镁0.8-1.5g、氯化钠1.26-1.86g、氯化钾0.35-0.56g、氯化镁0.28-0.52g、六水合三氯化铬5.6-7.8mg、葡萄糖酸铜 12.6-17.6mg、三水合乳酸亚铁72.6-101.6mg、一水合硫酸锰11.6-16.2mg、二水合钼酸钠 3.9-5.5mg、亚硒酸钠11.2-15.7mg、一水合硫酸锌26.6-37.2mg、10％碘化钾2.2-2.7g。
优选的，所述特定全营养配方食品1000ml计，包含：蛋白质66g、脂肪64g、碳水化合物108g、膳食纤维11g、库拉索芦荟粉8g、维生素1.1g、矿物质12.5g、水730g，蛋白质、脂肪和碳水化合物的供能比为25％：40％：35％。
优选的，所述蛋白质来源于豌豆蛋白15.5g、大豆分离蛋白15.5g、小麦低聚肽35g。
优选的，所述脂肪包含低芥酸菜籽油28g、中链甘油三酯28g、植物甾醇酯1.2g、鱼油 1.3g。
优选的，所述碳水化合物包含麦芽糊精108g。
优选的，所述维生素包含维生素A 3.6mg、维生素C 430mg、维生素D3 15.6μg、维生素 E 130mg、维生素K1 79.3μg、维生素B1 3.96mg、维生素B2 2.9mg、维生素B6 4.0mg、泛酸9.2mg、生物素7.0mg、叶酸4.8ug、烟酰胺12.9mg、维生素B12 3.9μg、胆碱350mg。
优选的，所述矿物质包含一水合柠檬酸钾4.49g、柠檬酸2.6g、二水合柠檬酸钠0.92g、氯化钙0.56g、磷酸氢二钾0.58g、磷酸氢镁1.2g、氯化钠1.43g、氯化钾0.42g、氯化镁0.32g、六水合三氯化铬6.1mg、葡萄糖酸铜12.8mg、三水合乳酸亚铁82.2mg、一水合硫酸锰12.3mg、二水合钼酸钠5.0mg、亚硒酸钠13.1mg、一水合硫酸锌30.6mg、10％碘化钾2.4g。
优选的，所述特定全营养配方食品还包含乳化剂至少1.3g，包括大豆磷脂，辛烯基琥珀酸淀粉钠中的至少一种。
本发明还提供一种所述的特殊医学用途食品的制备方法，制备方法包括将上述成分按照一定的顺序混合均匀，包括以下步骤：
(1)大料溶解：在溶解罐中加入总量65％-75％的纯水，在强烈的振动搅拌下将固体原料按顺序加入到溶解罐中，使料液通过液面下进行回流均匀，均匀的分散在纯水中，同时避免产生过多的气泡及料液分层。整个配制过程中不断向乳液内通入氮气；
(2)油相制备：按顺序将油类原料及脂溶性维生素充分混匀溶解，加热至40-60℃；
(3)均质：将水相和油相充分混匀后降温至60℃左右进行均质；
(4)将均质后的料液冷却后灌装；
(5)终端灭菌：将产品置于旋转、喷淋式灭菌柜中灭菌，灭菌温度121℃，F0值8-12，得到成品。
本发明所述的特定全营养配方食品用于肿瘤患者的营养补充，包含人体需要的七大营养素，即碳水化合物、脂肪、蛋白质、维生素、矿物质、水和膳食纤维。本发明具有高脂肪、高能量、低碳水化合物、全面营养的特点，符合现代医学关于恶性肿瘤的营养治疗指南，具有明显的抗肿瘤作用，可改善肿瘤患者的营养状况。优选的，所述特定全营养配方食品包含的蛋白质、脂肪和碳水化合物的供能比为20％：45％：35％。
目前市售的肠内营养产品多以酪蛋白、乳清蛋白为蛋白质来源，不符合中国人长期以植物蛋白为主要蛋白质来源的饮食习惯。本发明所述特定全营养配方食品中蛋白质均来源于植物蛋白，包括豌豆蛋白、大豆分离蛋白和小麦低聚肽。其中，豌豆蛋白含有人体所必需的十八种氨基酸，属于全价蛋白质。能够帮助提高免疫力，调节肠胃，全面补充氨基酸，促进病后术后恢复，促进胶原蛋白合成，同时其中的生物活性肽具有抗氧化、抗肿瘤、降低血糖及胆固醇含量的作用。大豆分离蛋白是以大豆或食用大豆粕为主要原料，加工制成的食品工业用大豆蛋白。我国传统饮食讲究“五谷宜为养，失豆则不良”，意思是说五谷很有营养，但没有豆类就容易失去平衡。大豆分离蛋白主要由11S和7S球蛋白组成，而且蛋白质组成中人体必需的8种氨基酸较为平衡，尤以赖氨酸最高。同时还含有大量对人体健康有益的必需脂肪酸、磷脂和丰富的钙、磷等矿物质且不含胆固醇，具有较高的营养价值，利于患者瘦体质的恢复，又具有较少的免疫原性。
谷氨酰胺是组成蛋白质常见的20种氨基酸的一种，是哺乳动物的非必需氨基酸，在体内可以由葡萄糖转变而来。Gln是快速更新组织细胞代谢的能量来源，是蛋白质合成和抗氧化物质形成的前体物质。Gln上调谷胱甘肽，从而提高抗肿瘤细胞活性及抑制肿瘤生长的作用。机体在饥饿、创伤、酸中毒及过度运动等应激状态下，对谷氨酰胺的需求量远远超过人体合成谷氨酰胺的能力，就需要额外摄入谷氨酰胺，以维持人体的需要。研究发现，以植物蛋白为原料获得的谷氨酰胺含量高于动物蛋白。而小麦低聚肽中含有的谷氨酰胺最高，达到了24％以上。因此，本发明使用小麦低聚肽，在提供蛋白质的同时，为机体提供足量的谷氨酰胺，提高肿瘤患者的免疫力。
精氨酸对免疫功能的具有促进作用，可以抑制肿瘤生长，防止肿瘤复发、转移，降低围手术期感染率和减轻免疫抑制，同时也影响了肿瘤细胞的增殖动力学，可以调节肿瘤细胞对周期性化疗药物的敏感性，提高术后机体的细胞和体液免疫功能，增强机体抗肿瘤能力。
本发明所述特定全营养配方食品中的脂肪来源于低芥酸菜籽油、中链甘油三酯、植物甾醇酯和鱼油。其中低芥酸菜籽油中油酸含量达60％以上，与花生油、玉米油、大豆油、橄榄油等相比，饱和脂肪酸含量最低，且含有合理的亚油酸和亚麻酸，在国际上被称为“最健康的食用植物油”。低芥酸菜籽油中的菜籽多酚是油菜籽独有的一类次级代谢产物，具有抗肿瘤、降血糖、抑菌、清除自由基等生物活性，有助于肿瘤患者提高免疫力。中链甘油三酯易氧化供能，利于改善肿瘤患者的能量代谢。鱼油富含EPA和DHA，能调节免疫反应，诱导肿瘤患者炎症缓解。植物甾醇能够抑制致癌物质的产生，通过诱导非正常细胞周期的细胞进行细胞周期停滞，刺激肿瘤细胞脱噬来抑制肿瘤细胞的生长和繁殖。植物甾醇还能够结合到细胞膜中，具有改变膜流动性和膜结合酶的能力，能够改变引起肿瘤生长的信号传导路径，抑制肿瘤血管的生长和转移。植物甾醇还能够增强人外周血液淋巴细胞和T细胞增殖，刺激免疫功能，产生免疫应答。
芦荟中的粘稠物质多糖类具有提高免疫力和抑制、破坏异常细胞的生长的作用，从而达到抗癌目的。芦荟产品中仅有库拉索芦荟凝胶可用于食品生产加工，每日食用量应不大于30 克。2008年被列为新食品原料的库拉索芦荟粉含有丰富的蛋白质和脂肪，多种化合物和微量元素，能够清除体内毒素，增强肿瘤患者的免疫力。
本发明在配方中添加了适量的维生素和矿物质，包括常量元素、必需微量元素、脂溶性维生素和水溶性维生素。多种维生素和矿物质的配合使用，可以对机体的物质和能量代谢起到重要的调节作用。
具体实施方式
为使本领域的技术人员更好地理解本发明的技术方案，下面对本发明提供的一种用于肿瘤患者的特定全营养配方食品及其制备方法进行详细描述。
实施例1
1.原料投料如表1所示：
表1：本发明所述营养剂的制备原料
制备方法：
(1)大料溶解：在溶解罐中加入总量65-75％的纯水，在强烈的振动搅拌下将固体原料按顺序加入到溶解罐中，使料液通过液面下进行回流均匀，均匀的分散在纯水中，同时避免产生过多的气泡及料液分层。整个配制过程中不断向乳液内通入氮气。
(2)油相制备：按顺序将油类原料及脂溶性维生素充分混匀溶解，加热至40-60℃。
(3)均质：将水相和油相充分混匀后降温至60℃左右进行均质。
(4)将均质后的料液冷却后灌装。
(5)终端灭菌：将产品置于旋转、喷淋式灭菌柜中灭菌，灭菌温度121℃，F0值8-12，得到成品。
实施例中肿瘤特定全营养配方食品对SPF小鼠动物试验研究
试验目的：本实施例所述肿瘤特定全营养配方食品对SPF小鼠胰腺指数、胸腺指数及血清学指标的影响。
试验方法：取BALB/c Nude 6-8周龄小鼠30只，体重(20±2)g，于每只小鼠右侧腋部皮下接种0.2mL瘤细胞悬液，模型建立24h后，随机分为2组，每组15只，雌雄各半。试验组小鼠灌喂实施例所述肿瘤特定全营养配方食品，对照组小鼠灌喂等热量、等氮量常规肠内营养乳剂。食用剂量为0.3g/天，一天分3次喂养，自由饮水，持续14天。末次给药后次日处死小鼠，称取小鼠体重，皮下瘤块、脾脏及胸腺重量，并计算脾脏指数和胸腺指数，同时取血样检测血清总蛋白、前白蛋白和血清CD4/CD8比值。
检测指标：
(1)脏器指数测定：胸腺是免疫系统的中枢免疫器官，是调控免疫系统的重要内分泌腺；脾脏是体内最大的外周免疫器官，含有大量的免疫细胞和免疫因子。因此，胸腺指数和脾脏指数可以直接反映机体免疫状态。
脾脏指数＝脾脏质量(mg)/体重(g)，胸腺指数＝胸腺质量(mg)/体重(g)；
(2)血清指标测定：取全血，离心，取血清，检测血清总蛋白、前白蛋白和血清CD4/CD8 比值。肿瘤患者的营养不良主要表现为蛋白质的消耗，血清总蛋白含量可以体现机体的营养水平；前白蛋白(PAB)是一种灵敏的营养蛋白质指标，PAB在急性炎症、恶性肿瘤、肝硬化或肾炎时其血浓度下降；血清CD4/CD8比值作为免疫调节的一项指标，正常值约1.4-2.0，若其比值＞2.0或＜1.4，表明细胞免疫功能紊乱。
统计方法：采用组间t检验，p值小于或等于0.05认为检验的差别有统计学意义。
试验结果：
(1)肿瘤特定全营养配方食品对小鼠脾脏指数及胸腺指数的影响
表2.1肿瘤特定全营养配方食品对小鼠脾脏指数和胸腺指数的影响(n＝15，x±s)
注：与对照组相比较，a P＜0.05
(2)肿瘤特定全营养配方食品对小鼠血清学指标的影响
表2.2肿瘤特定全营养配方食品对小鼠血清学指标的影响(n＝15，x±s)
注：与对照组相比较，a P＜0.05
研究结果
(1)如表2.1所示，与对照组相比，实验组脾脏指数和胸腺指数显著增加，表明该特定全营养配方食品能够有效促进小鼠免疫器官的生长，提高机体的免疫能力。
(2)如表2.2所示，与对照组相比，实验组的血清总蛋白、前白蛋白及CD4/CD8比值均显著升高，说明该特定全营养配方食品不仅能较好地改善机体的营养状况，而且能够有效的提高免疫力。
上面对本发明的实例作了详细说明，但是本发明并不限于上述实例，凡对本发明所作的任何改进和变型均属本发明权利要求的保护范围。
Claims (9)
1.一种用于肿瘤患者的特定全营养配方食品，其特征在于，所述特定全营养配方食品1000ml计，包含：蛋白质55-90g、脂肪53-71g、碳水化合物95-125g、膳食纤维9-16g、库拉索芦荟粉8-12g、维生素0.8-1.5g、矿物质10-19g、水650-750g，其中：
所述蛋白质包含豌豆蛋白11.5-19g、大豆分离蛋白11.5-19g、小麦低聚肽23-39g；
所述脂肪包含低芥酸菜籽油25-33g、中链甘油三酯25-33g、植物甾醇酯1.0-1.5g、鱼油1.2-1.6g；
所述碳水化合物包含麦芽糊精95-125g；
所述膳食纤维包含大豆纤维至少5.6g和低聚果糖至少3.0g；
所述维生素包含维生素A 3-5.6mg、维生素C 405-515mg、维生素D3 13-21μg、维生素E112-170mg、维生素K1 69-127μg、维生素B1 2.9-6.0mg、维生素B2 2.0-3.7mg、VB6 2.7-5.3mg、泛酸7.7-15.4mg、生物素5.7-9.3mg、叶酸4.3-6.3mg、烟酰胺9.7-18.7mg、维生素B123.7-5.3μg、胆碱296-450mg；
所述矿物质包含一水合柠檬酸钾3.98-5.65g、柠檬酸2.3-3.3g、二水合柠檬酸钠0.72-1.16g、氯化钙0.42-0.76g、磷酸氢二钾0.52-0.79g、磷酸氢镁0.8-1.5g、氯化钠1.26-1.86g、氯化钾0.35-0.56g、氯化镁0.28-0.52g、六水合三氯化铬5.6-7.8mg、葡萄糖酸铜12.6-17.6mg、三水合乳酸亚铁72.6-101.6mg、一水合硫酸锰11.6-16.2mg、二水合钼酸钠3.9-5.5mg、亚硒酸钠11.2-15.7mg、一水合硫酸锌26.6-37.2mg、10％碘化钾2.2-2.7g。
2.根据权利要求1所述的用于肿瘤患者的特定全营养配方食品，其特征在于，所述特定全营养配方食品1000ml计，包含：蛋白质66g、脂肪64g、碳水化合物108g、膳食纤维11g、库拉索芦荟粉8g、维生素1.1g、矿物质12.5g、水730g，蛋白质、脂肪和碳水化合物的供能比为25％：40％：35％。
3.根据权利要求2所述的用于肿瘤患者的特定全营养配方食品，其特征在于，所述蛋白质来源于豌豆蛋白15.5g、大豆分离蛋白15.5g、小麦低聚肽35g。
4.根据权利要求3所述的用于肿瘤患者的特定全营养配方食品，其特征在于，所述脂肪包含低芥酸菜籽油28g、中链甘油三酯28g、植物甾醇酯1.2g、鱼油1.3g。
5.根据权利要求4所述的用于肿瘤患者的特定全营养配方食品，其特征在于，所述碳水化合物包含麦芽糊精108g。
6.根据权利要求5所述的用于肿瘤患者的特定全营养配方食品，其特征在于，所述维生素包含维生素A 3.6mg、维生素C 430mg、维生素D3 15.6μg、维生素E 130mg、维生素K1 79.3μg、维生素B1 3.96mg、维生素B2 2.9mg、维生素B6 4.0mg、泛酸9.2mg、生物素7.0mg、叶酸4.8ug、烟酰胺12.9mg、维生素B12 3.9μg、胆碱350mg。
7.根据权利要求6所述的用于肿瘤患者的特定全营养配方食品，其特征在于，所述矿物质包含一水合柠檬酸钾4.49g、柠檬酸2.6g、二水合柠檬酸钠0.92g、氯化钙0.56g、磷酸氢二钾0.58g、磷酸氢镁1.2g、氯化钠1.43g、氯化钾0.42g、氯化镁0.32g、六水合三氯化铬6.1mg、葡萄糖酸铜12.8mg、三水合乳酸亚铁82.2mg、一水合硫酸锰12.3mg、二水合钼酸钠5.0mg、亚硒酸钠13.1mg、一水合硫酸锌30.6mg、10％碘化钾2.4g。
8.根据权利要求1至7中任意一条所述的用于肿瘤患者的特定全营养配方食品，其特征在于，所述特定全营养配方食品还包含乳化剂至少1.3g，包括大豆磷脂，辛烯基琥珀酸淀粉钠中的至少一种。
9.一种如权利要求8中所述的用于肿瘤患者的特定全营养配方食品的制备方法，其特征在于，包括以下步骤：
(1)大料溶解：在溶解罐中加入总量65％-75％的纯水，在强烈的振动搅拌下将固体原料按顺序加入到溶解罐中，使料液通过液面下进行回流均匀，均匀的分散在纯水中，同时避免产生过多的气泡及料液分层，整个配制过程中不断向乳液内通入氮气；
(2)油相制备：按顺序将油类原料及脂溶性维生素充分混匀溶解，加热至40-60℃；
(3)均质：将水相和油相充分混匀后降温至60℃左右进行均质；
(4)将均质后的料液冷却后灌装；
(5)终端灭菌：将产品置于旋转、喷淋式灭菌柜中灭菌，灭菌温度121℃，F0值8-12，得到成品。
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