CN108294306A - 一种氨基酸型全营养特殊医学用途配方食品 - Google Patents
一种氨基酸型全营养特殊医学用途配方食品 Download PDFInfo
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- CN108294306A CN108294306A CN201810286028.4A CN201810286028A CN108294306A CN 108294306 A CN108294306 A CN 108294306A CN 201810286028 A CN201810286028 A CN 201810286028A CN 108294306 A CN108294306 A CN 108294306A
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Abstract
本发明属于特殊医学用途配方食品领域，具体公开了一种氨基酸型全营养特殊医学用途配方食品，包括氨基酸、碳水化合物、脂肪、复合维生素、牛磺酸、左旋肉碱、复合矿物质、甜味剂、香精和酸度调节剂。本发明的氨基酸型全营养特殊医学用途配方食品提供全面均衡营养，能够作为唯一营养来源，氮源为单体氨基酸易于消化吸收，低脂无渣,适用于进食受限、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，尤其是重症代谢障碍及胃肠道功能障碍的病人。
Description
技术领域
本发明属于特殊医学用途配方食品领域，具体涉及一种氨基酸型全营养特殊医学用途配方食品。
背景技术
特医食品是特殊医学用途配方食品的简称。一般按其提供营养素是否全面分为三类：全营养特医食品、特定全营养特医食品和非全营养特医食品。
特定全营养特医食品是为了满足进食受阻、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。特殊医学用途配方食品是食品不是药品，不能对疾病和临床症状进行预防和治疗，但可以提供营养支持，起到营养“治疗”的作用，具有免疫调控、维护胃肠道功能与结构、促进伤口愈合、改善病人生存率缩短住院时间等作用。在我国，营养不良主要集中于以下人群：住院病人、接受家庭看护或社区护理的人，其中老年人群尤其常见。在亚洲，约40％的住院病人营养不良或存在营养不良的风险。在低收入、患有慢性病、长期或严重患有疼痛的病人中，营养不良更加普遍。国际经验显示，经济越发达的地方，特医食品应用意识越强，比如日本的市场规模是360亿日元，欧美市场规模约为400—500亿元。而中国的市场规模仅占全球的1％，总量约为6亿元。中国与欧美市场形成鲜明对比，特医食品消费量远远落后于欧美发达国家，但近几年快速发展，平均增速超过37％。因此我国特医食品需求及市场将比较有前景。
目前主要的肠内营养制剂产品大多还是来自国外，这些产品占据中国市场90％的市场份额，如中国和瑞典合资的华瑞制药有限公司、荷兰的纽迪希亚制药有限公司、美国雅培制药有限公司、雀巢公司。目前市场上的特殊医学用途配方食品主要为整蛋白型或者短肽型，而氨基酸型配方的产品相对较少。胃肠道，尤其是胰腺在消化和吸收营养素方面扮演重要的角色，而胰腺功能受损将会对机体产生不良的影响。无论是经口、十二指肠还是空肠给予，要素型都比整蛋白型肠内营养更少刺激胰腺分泌，不需要酶解消化即可吸收，优于整蛋白型配方。
中国专利申请201610223264.2公开了一种肿瘤患者特殊医学用途营养配方食品及其制备方法，该肠内营养制剂中含有如下有效成分：蛋白质、脂肪、碳水化合物、复合维生素、复合矿物质、牛磺酸、胆碱等。蛋白质源于鱿鱼内脏糖蛋白；脂肪脂肪来源于α-亚麻酸、亚油酸、棕榈油、花生油中的一种或多种的组合物；碳水化合物来源于葡萄糖、果糖、麦芽糊精、灵芝多糖、玉米淀粉中的一种或多种的组合物。该配方食品营养素配比比较均衡、然而该配方食品为整蛋白型配方食品，因而在营养的消化吸收方面欠佳。
现有的氨基酸医学配方食品，由于配方组分含中有多种中药材组分，因而不宜长期食用；或者组分过于复杂，配方食品成本高。
中国专利申请201510160692.0公开了一种胃癌医学配方食品，该配方食品结合胃癌患者的体质特征，依据传统中医的精髓理论，因人而异，黄金配伍以一种、几种或全部的药食两用中药提取物精华及新资源食品、多种益生菌、短肽为主要原料，以益生元、碳水化合物、氨基酸、有保健功能的油脂、多种维生素、多种矿物质为辅料制成的医学配方食品；按下列原料及其用量进行配方,药食两用的提取物及新资源食品：冬虫夏草(冬虫夏草菌丝体)12g、石斛12g、灵芝孢子粉(破壁)11g、灵芝11g、沙参10g、丹参10g、麦冬9g、川贝9g、白花蛇舌草9g、党参8g、青皮8g、蛹虫草8g、白背三七8g、佛手7g、桃仁7g、银花7g、蒲公英7g、鸡内金7g、牡蛎6g、山楂6g、橘红6g、丁香6g、砂仁6g、薏苡仁6g、芡实5g、乌梅5g、无花果5g、海藻5g、昆布5g、鱼腥草5g、马齿苋5g、桑椹5g、线叶金雀花5g、杜仲雄花4g、裸藻4g、丹凤牡丹花4g、乌药叶4g、辣木叶3g、诺丽果3g、针叶樱桃果3g、梨果仙人掌3g、沙棘叶3g、天贝2g、耳叶牛皮消2g、夏枯草2g、青钱柳叶2g、茶叶茶氨酸1g、茶树花1g、广东虫草子1g，酵母β-葡聚糖5g、雪莲培养物3g、茶藨子叶状层菌发酵菌丝体2g、蛋白核小球藻1g、多种益生菌300g、短肽200g、益生元100g、多种氨基酸100g、碳水化合物100g、有保健功能的油酯100g、维生素A0.01g、维生素D0.000015g、维生素E0.12g、维生素K0.0075g、维生素K10.00001g、维生素C10.625g、维生素B10.016g、维生素B20.016g、维生素B60.015g、维生素B0.0023g、维生素Be、维生素Bu、烟酸0.2g、叶酸0.003g、泛酸0.051g、胆碱2.5g、生物素0.000057g、钙6.2g、磷4.5g、钾10g、钠16.17g、镁1.7g、氯、铁0.15g、锌6.2g、硒0.00012g、铜0.007g、锰0.018g、碘0.00001g、氟0.00001g、铬0.00001g、钼0.00001g。
中国专利申请201510173027.5公开了一种便秘医学配方食品，该配方食品是结合便秘患者的体质特征，依据传统中医的精髓理论，因人而异，黄金配伍以一种、几种或全部的药食两用中药提取物精华及新资源食品、多种益生菌、短肽为主要原料，以益生元、碳水化合物、氨基酸、有保健功能的油脂、多种维生素、多种矿物质为辅料制成的医学配方食品；按下列原料及其用量进行配方,药食两用的提取物及新资源食品：石斛14g、番泻叶14g、生大黄14g、黄芪12g、车前子12g、蛹虫草12g、火麻仁12g、郁李仁12g、苏子12g、胖大海10g、蒲公英10g、甘草10g、决明子10g、莱菔子10g、百合10g、玉竹10g、芦荟8g、橘皮8g、山楂8g、桑椹8g、杏仁8g、乌梅8g、沙棘6g、罗汉果6g、桃仁6g、黄精6g、赤小豆6g、魔芋6g、麦芽6g、鱼腥草6g、金银花4g、螺旋藻4g、膳食纤维4g、酵母3g、裸藻3g、奇亚籽2g、圆苞车前子壳2g、杜仲雄花1g、乳矿物盐1g、多种益生菌300g、短肽200g、益生元100g、多种氨基酸100g、碳水化合物100g、有保健功能的油酯100g、维生素A0.01g、维生素D0.000015g、维生素E0.12g、维生素K0.0075g、维生素K10.00001g、维生素C10.625g、维生素B10.016g、维生素B20.016g、维生素B60.015g、维生素B0.0023g、维生素Be、维生素Bu、烟酸0.2g、叶酸0.003g、泛酸0.051g、胆碱2.5g、生物素0.000057g、钙6.2g、磷4.5g、钾10g、钠16.17g、镁1.7g、氯、铁0.15g、锌6.2g、硒0.00012g、铜0.007g、锰0.018g、碘0.00001g、氟0.00001g、铬0.00001g、钼0.00001g。
上述两个配方食品均以益生元、碳水化合物、氨基酸、有保健功能的油脂、多种维生素、多种矿物质为辅料制成的医学配方食品，然而其未明确氨基酸的种类，而且所采用的原料包括多种中药成分，不宜长期食用。
另外，由于我国特殊医学用途配方食品的前身为肠内营养产品，被冠以“药品”的名义引入中国，所以往往忽略了产品的口味要求。
发明内容
本发明的目的是克服现有技术中要素型特殊医学用途配方食品存在的问题，以及产品口味和风味的问题，提供一种氨基酸型全营养特殊医学用途配方食品，适用于进食受限、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，尤其是重症代谢障碍及胃肠道功能障碍病人的肠内营养支持；同时解决产品的口味和风味不佳的问题。
本发明的技术方案是：一种氨基酸型全营养特殊医学用途配方食品，包括氨基酸、碳水化合物、脂肪、复合维生素、牛磺酸、左旋肉碱和复合矿物质。
进一步地，所述氨基酸型全营养特殊医学用途配方食品还包括口味调节剂，所述口味调节剂包括甜味剂、香精和酸度调节剂；所述香精优选芒果香精。进一步地，一种氨基酸型全营养特殊医学用途配方食品，包含以下营养成分：
更进一步地，所述口味调节剂包括：
甜味剂 0.3～0.34g
香精 0.75～0.92g
酸度调节剂 0.15～0.20g。
更进一步地，一种氨基酸型全营养特殊医学用途配方食品，包含以下营养成分：
更进一步地，所述口味调节剂中甜味剂、香精和酸度调节剂的重量比为(1.8-2.1)：(4.6-5.1)：1。
进一步地，所述氨基酸包含人体必需的8种氨基酸。
进一步地，所述氨基酸包括如下18种氨基酸：甘氨酸、L-丙氨酸、L-精氨酸、L-天门冬氨酸、L-盐酸半胱氨酸、L-谷氨酰胺、L-组氨酸、L-异亮氨酸、L-亮氨酸、L-盐酸赖氨酸、L-蛋氨酸、L-苯丙氨酸、L-脯氨酸、L-丝氨酸、L-苏氨酸、L-色氨酸、L-酪氨酸和L-缬氨酸。
本发明食品中包含亮氨酸、异亮氨酸和缬氨酸三种支链氨基酸，以及具有免疫功能的谷氨酰胺和精氨酸，五种氨基酸相互配合，提高机体的免疫活性。其中，L-精氨酸是一种条件必需性氨基酸，它可以用于蛋白质的合成；也是多种代谢物的前体，包括多胺和一氧化氮，这些代谢物有强大的免疫调节作用。L-精氨酸摄入量的减少会导致T细胞繁殖和CD3ζ链表达的减少。T细胞被激活后快速代谢精氨酸，并在酶的作用下生成多种免疫活性物质，比如多胺和一氧化氮，提高机体的免疫活性，影响病人的生存率和住院周期。谷氨酰胺可促进淋巴细胞、巨噬细胞的有丝分裂和分化增殖，增加肿瘤坏死因子(TNF-α)、白细胞介素(IL-1)等细胞因子的产生，明显增加危重患者的淋巴细胞总数，增强机体的免疫力。支链氨基酸包括缬氨酸、亮氨酸和异亮氨酸。支链氨基酸尤其是亮氨酸，可以刺激蛋白质合成，抑制蛋白质分解，促进谷氨酰胺合成。此外，支链氨基酸能刺激单核细胞增殖，调节细胞因子的分泌，促进Th1型免疫反应的发展。此外支链氨基酸可促进伤口皮肤胶原蛋白增生及加快皮肤愈合。
更进一步地，所述18种氨基酸的含量如下：甘氨酸0.37～0.55g、L-丙氨酸0.47～0.71g、L-精氨酸0.70～1.06g、L-天门冬氨酸0.64～0.96g、L-盐酸半胱氨酸0.16～0.24g、L-谷氨酰胺1.18～1.76g、L-组氨酸0.22～0.32g、L-异亮氨酸0.76～1.14g、L-亮氨酸1.52～2.38g、L-盐酸赖氨酸0.58～0.86g、L-蛋氨酸0.18～0.28g、L-苯丙氨酸0.47～0.71g、L-脯氨酸0.45～0.67g、L-丝氨酸0.27～0.41g、L-苏氨酸0.37～0.55g、L-色氨酸0.12～0.18g、L-酪氨酸0.08～0.12g和L-缬氨酸0.76～1.14g。
进一步地，所述碳水化合物来源于麦芽糊精、玉米淀粉中的一种或者两种。
进一步地，所述脂肪包括红花油和亚麻籽油，所述红花油和亚麻籽油的重量比为(1～2.5)：1；其中，脂肪的供能比仅为6％-9％，不饱和脂肪酸占脂肪总质量的70％-85％。
红花油属于高度不饱和脂肪酸油类，亚油酸含量高达80％以上，能够降低血脂与胆固醇而发挥医疗保健作用。亚油酸是一种人体自身不能合成，必须通过饮食获得的必需脂肪酸，是一种18碳长链不饱和ω-6脂肪酸。亚油酸属于ω-6脂肪酸的母体脂肪酸，机体可以利用母体脂肪酸合成更长链的脂肪酸，比如花生四烯酸。亚油酸作为最早被确认的必需脂肪酸，具有降低血清胆固醇水平的作用，摄入大量的亚油酸对高甘油三酯患者群有明显的作用。亚油酸对高血压、高血脂、心绞痛、动脉粥样硬化、老年性肥胖症等的防治极为有利，能起到防止人体血清胆固醇在血管壁的沉积，有“血管清道夫”的美誉。亚麻籽油是目前ω-3脂肪酸含量最高的植物油脂之一，α-亚麻酸的的含量约为45％-65％。α-亚麻酸与亚油酸一样，也是一种必需脂肪酸，人体不能合成，必须从食物中摄取得到。α-亚麻酸属于ω-3脂肪酸的母体脂肪酸，机体可以利用亚麻酸合成更长链的ω-3族脂肪酸，比如DHA和EPA。α-亚麻酸有降低血脂、降低血压、预防心血管疾病的作用，还有增强免疫力与抗炎的作用。
本发明的脂肪在满足机体的必需脂肪酸需求的前提下，不加重病人的消化负担。
进一步地，所述复合维生素包括：维生素A、维生素D、维生素E、维生素K、维生素B1、维生素B2、维生素B6、维生素B12、烟酸、叶酸、泛酸、维生素C、生物素和胆碱。
更进一步地，所述复合维生素中各组分的含量如下：维生素A182.4～456μg RE、维生素D2.42～4.54μg、维生素E2.4～6mgα-TE、维生素K20～40μg、维生素B1 0.36～0.68mg、维生素B2 0.41～0.77mg、维生素B6 0.48～0.90mg、维生素B12 1.44～2.70μg、烟酸4.8～9mg、叶酸86～180μg、泛酸2.4～4.5mg、维生素C17～60mg、生物素72～135mg和胆碱64～150mg。
进一步地，所述复合矿物质包括：钠、钾、铜、镁、铁、锌、锰、钙、磷、碘、氯、硒、铬和钼。
更进一步地，所述复合矿物质中各组分的含量如下：钠290～420mg、钾342～540mg、铜240～420μg、镁56.4～91.6mg、铁2.8～4.5mg、锌2.70～4.06mg、锰240～360μg、钙165～240mg、磷125～180mg、碘20.8～35.2μg、氯80～220mg、硒10.4～15.6μg、铬14.4～21.6μg和钼16～24μg。
本发明复合矿物质中钠来源于柠檬酸钠、碳酸氢钠、磷酸氢二钠、磷酸二氢钠和氯化钠中的一种或多种；钾来源于柠檬酸钾、葡萄糖酸钾、磷酸二氢钾、磷酸氢二钾和氯化钾中的一种或多种；铜来源于硫酸铜、柠檬酸铜、碳酸铜和柠檬酸铜中的一种或多种；镁来源于硫酸镁、葡萄糖酸镁、氯化镁、氧化镁、碳酸镁和磷酸氢镁中的一种或多种；铁来源于硫酸亚铁、焦磷酸铁、柠檬酸铁、柠檬酸铁铵、葡萄糖酸亚铁和富马酸亚铁中的一种或多种；锌来源于硫酸锌、葡萄糖酸锌、氧化锌、乙酸锌、乳酸锌、柠檬酸锌和氯化锌中的一种或多种；锰来源于硫酸锰；钙来源于L-乳酸钙、碳酸钙、葡萄糖酸钙、柠檬酸钙、磷酸氢钙、氯化钙、磷酸三钙、氧化钙和硫酸钙中的一种或多种；磷来源于磷酸二氢钾、磷酸三钙、磷酸氢钙和磷酸二氢钠中的一种或多种；碘来源于碘化钾、碘酸钾和碘化钠中的一种或多种；硒来源于亚硒酸钠和硒酸钠中的一种或两种；铬来源于氯化铬和硫酸铬中的一种或两种；钼来源于钼酸钠和钼酸铵中的一种或两种；氯来源于L-盐酸半胱氨酸、L-盐酸赖氨酸、氯化钠和氯化钾中的一种或多种。
本发明所述甜味剂来源于复合甜味剂。所述香精来源于芒果香精。所述酸度调节剂来源于柠檬酸。本发明的食品中的氮源为氨基酸，再加上多种组分混合在一起，导致食品具有口涩味，通过口味调节剂的调节，所得配方食品具有良好的口味和风味。
本发明的氨基酸型全营养特殊医学用途配方食品被制备成合适服用的制剂形式，所述制剂选自散剂、颗粒剂、胶囊剂、片剂和乳剂中的一种。
本发明的氨基酸型全营养特殊医学用途配方食品适用于进食受限、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，尤其是重症代谢障碍及胃肠道功能障碍的病人的肠内营养支持。
本发明根据重症代谢障碍及胃肠道功能障碍的病人的营养需求以及代谢特点，对配方中各营养成分进行更加合理的搭配，主要优点如下：
(1)氮源以氨基酸的形式存在，无需酶解即可吸收，有助于减轻胃肠道负担，也可以用于重症代谢障碍及胃肠道功能障碍的病人。
(2)本发明食品为低脂配方，不加重病人的消化负担；本发明脂肪来源于红花油和亚麻籽油，满足机体对必须脂肪酸的需求。
(3)本发明食品包含亮氨酸、异亮氨酸和缬氨酸三种支链氨基酸，以及具有免疫功能的谷氨酰胺和精氨酸，提高机体的免疫活性。
(4)本发明对食品进行调味处理，解决原味产品的口味和风味不佳的问题；而且品味调节剂独立包装，可以根据服用方式的不同，比如口服和管饲，选择性添加调味包。
(5)本发明的氨基酸型全营养特殊医学用途配方食品提供全面均衡营养，易于消化吸收，适用于进食受限、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，尤其是重症代谢障碍及胃肠道功能障碍的病人。
具体实施方式
实施例1
一种氨基酸型全营养特殊医学用途配方食品，包含以下成分，见表1。
表1
其中，碳水化合物来源为麦芽糊精和玉米淀粉，脂肪来源为红花油微囊粉和亚麻籽油微囊粉，二者的重量比为2：1。
复合矿物质中钠来源于柠檬酸钠；钾来源于柠檬酸钾和磷酸二氢钾；铜来源于硫酸铜；镁来源于硫酸镁；铁来源于焦磷酸铁；锌来源于硫酸锌；锰来源于硫酸锰；钙来源于L-乳酸钙；磷来源于磷酸二氢钾；碘来源于碘化钾；硒来源于亚硒酸钠；铬来源于氯化铬；钼来源于钼酸钠；氯来源于L-盐酸半胱氨酸和L-盐酸赖氨酸。
实施例2
一种氨基酸型全营养特殊医学用途配方食品，包含以下成分，见表2。
表2
其中，碳水化合物来源为麦芽糊精，脂肪来源为红花油微囊粉和亚麻籽油微囊粉，二者的重量比为1.5：1。
复合矿物质中钠来源于碳酸氢钠和氯化钠；钾来源于葡萄糖酸钾和磷酸二氢钾；铜来源于硫酸铜和柠檬酸铜；镁来源于硫酸镁；铁来源于葡萄糖酸亚铁和富马酸亚铁；锌来源于硫酸锌；锰来源于硫酸锰；钙来源于L-乳酸钙和碳酸钙；磷来源于磷酸二氢钾；碘来源于碘化钾；硒来源于亚硒酸钠；铬来源于氯化铬；钼来源于钼酸钠；氯来源于L-盐酸半胱氨酸、L-盐酸赖氨酸和氯化钠。
实施例3
一种氨基酸型全营养特殊医学用途配方食品，包含以下成分，见表3。
表3
其中，碳水化合物来源为麦芽糊精，脂肪来源为红花油微囊粉和亚麻籽油微囊粉，二者的重量比为2.5：1。
复合矿物质中钠来源于柠檬酸钠和碳酸氢钠；钾来源于柠檬酸钾、磷酸二氢钾和氯化钾；铜来源于硫酸铜；镁来源于硫酸镁；铁来源于焦磷酸铁；锌来源于硫酸锌；锰来源于硫酸锰；钙来源于L-乳酸钙和磷酸钙；磷来源于磷酸二氢钾；碘来源于碘化钾和碘化钠；硒来源于亚硒酸钠和硒酸钠；铬来源于氯化铬；钼来源于钼酸钠和钼酸铵；氯来源于L-盐酸半胱氨酸、L-盐酸赖氨酸和氯化钾。
实施例4
一种氨基酸型全营养特殊医学用途配方食品，包含以下成分，见表4。
表4
其中，碳水化合物来源为麦芽糊精和玉米淀粉，脂肪来源为红花油微囊粉和亚麻籽油微囊粉，二者的重量比为1：1。
复合矿物质中钠来源于碳酸氢钠；钾来源于葡萄糖酸钾；铜来源于硫酸铜和柠檬酸铜；镁来源于硫酸镁；铁来源于葡萄糖酸亚铁和富马酸亚铁；锌来源于硫酸锌；锰来源于硫酸锰；钙来源于L-乳酸钙；磷来源于磷酸二氢钾；碘来源于碘化钾；硒来源于亚硒酸钠；铬来源于氯化铬；钼来源于钼酸钠；氯来源于L-盐酸半胱氨酸和L-盐酸赖氨酸。
实施例5
一种氨基酸型全营养特殊医学用途配方食品，包含以下成分，见表5。
表5
其中，碳水化合物来源为玉米淀粉和麦芽糊精，脂肪来源为红花油微囊粉和亚麻籽油微囊粉，二者的重量比为2.5：1。
复合矿物质中钠来源于碳酸氢钠；钾来源于葡萄糖酸钾和磷酸二氢钾；铜来源于硫酸铜和柠檬酸铜；镁来源于硫酸镁；铁来源于富马酸亚铁；锌来源于硫酸锌；锰来源于硫酸锰；钙来源于L-乳酸钙和碳酸钙；磷来源于磷酸二氢钾；碘来源于碘化钾；硒来源于亚硒酸钠；铬来源于氯化铬；钼来源于钼酸钠；氯来源于L-盐酸赖氨酸和氯化钠。
试验例
口味调节剂含量试验
表6为6组不同氨基酸全营养配方食品口味调节剂。
表6
以上6组的原味样品中每组的组分含量如表7所示
表7
随机选取5位品评者，对以上6组的滋味按照评分标准进行评分，对评分进行汇总，进行组间分析。
按照产品滋味评分标准进行滋味评价，将产品口味按优、良、中、差四个等级评定。评分标准见表8。
表8产品滋味评分标准
滋味评价结果如表9所示。
表9产品滋味评价结果
| 组别 | 评价人A | 评价人B | 评价人C | 评价人D | 评价人E |
| 1 | 差 | 差 | 差 | 差 | 差 |
| 2 | 中 | 中 | 中 | 中 | 差 |
| 3 | 中 | 中 | 良 | 中 | 良 |
| 4 | 良 | 良 | 良 | 良 | 中 |
| 5 | 优 | 优 | 良 | 优 | 优 |
| 6 | 优 | 优 | 优 | 优 | 优 |
效果例
本发明提供的氨基酸型全营养特殊医学用途配方食品对急性胰腺炎大鼠的影响试验：
取本发明实施例1所得配方食品进行试验，同时设对照组，对照进行肠外营养支持。
营养液的配制：(1)对照组：每100mL用6mL的20％中长链脂肪乳剂、53mL的7％复方氨基酸、39mL的50％葡萄糖溶液以及适量的维生素配制而成。(2)实验组：用发明实施例1～3所得配方食品，每份用250温开水溶解制成300mL的溶液。上述营养液每100mL含氮量及热量基本一致。
40只200-240g雄性SD大鼠(SPF级)采用结扎大鼠胰胆管并行右颈静脉插管的方法制备急性胰腺炎大鼠模型。将以上大鼠分为对照组和实验组两个组别，每组20只。造模后对照组和实验组分别按照上述营养液给予相应的营养支持2周(300kcal/kg)，营养液采用静脉注射。最终测量计算各组大鼠的体重增加、存活率以及机体免疫活性。所有数据以Mean±SD表示，采用Minitab 17.1.0软件进行单因素方差分析，进一步用Turkey多重比较确定各组数据间的显著性差异，显著水平设定为p<0.05。
氨基酸型全营养配方食品对大鼠体重的影响结果见表10。
表10氨基酸型全营养配方食品对大鼠体重的影响
由表10可知，与对照组相比，实验组大鼠的体重增加无显著性差异(P<0.05)，由此可见，样品对大鼠的体重增长没有显著性差异，可以维持其正常的生理功能。
2周后，对照组大鼠的存活率为68％，而实验组的存活率为79％，实验组的存活率为对照组的116.2％，所以本发明提供的氨基酸型全营养特殊医学用途配方食品可以提高急性胰腺炎大鼠的存活率。
2周后，采集门静脉和下腔静脉血，检测肿瘤坏死因子-α(TNF-α)、白细胞介素-6(IL-6)、C反应蛋白(CRP)以及T淋巴细胞总数，结果见表11。
表11营养支持两周后血清细胞因子和淋巴细胞比较
由表11可知，对照组和实验组TNF-α水平无显著差异(P<0.05)，但实验组的IL-6和CRP水平显著低于对照组(P<0.05)，所以本发明可以显著降低急性胰腺炎大鼠的炎症反应。对照组和实验组CD8+水平无显著差异(P<0.05)，但实验组的CD8+和CD4+/CD8+水平显著高于对照组(P<0.05)，说明本发明可以通过增加机体外周淋巴细胞的数量来提高机体细胞免疫功能。所以本发明可以提高机体细胞免疫功能，进而降低机体的炎症反应。
本发明提供的氨基酸型全营养特殊医学用途配方食品对急性胰腺炎患者营养状况的改善情况。
取本发明实施例1～3所得配方食品进行临床试验，同时设对照组，对照组进行肠外营养支持。
营养液的配制：(1)对照组：每100mL用6mL的20％中长链脂肪乳剂、53mL的7％复方氨基酸、39mL的50％葡萄糖溶液以及适量的维生素配制而成。(2)实验组：用发明实施例1～3所得配方食品，每份用250温开水溶解制成300mL的溶液。上述营养液每100mL含氮量及热量基本一致。
60例急性胰腺炎(SAP)患者，男37例，女23例，全部符合“中国急性胰腺炎诊治指南(草案)”标准中的SAP诊断。将60例患者随机分为对照组和实验组两个组别，每组30人，其中，对照组：男19人，女11人，实验组：男18人，女12人。将以上患者随机分为对照组和实验组，按照25kcal/(kg*d)给予营养支持3周。对照组通过中心静脉给予肠外营养，实验组的肠内营养液通过鼻肠管给予。
评价指标：每周测量一次体重、白蛋白和前白蛋白浓度来评估营养状态。每周测量一次CRP、IL-6和TNF-α来评估患者的炎症状态。每周测量一次CD8+、CD8+和CD4+/CD8+水平来评估机体的免疫状态。所有数据以Mean±SD表示，采用Minitab 17.1.0软件进行单因素方差分析，进一步用Turkey多重比较确定各组数据间的显著性差异，显著水平设定为p<0.05。
氨基酸型全营养配方食品对患者的体重影响如表12所示。
表12氨基酸型全营养配方食品对患者体重的影响
| 组别 | 1d | 7d | 14d | 21d |
| 实验组 | 58.2±5.2 | 57.3±6.2 | 56.4±9.5 | 58.3±4.1 |
| 对照组 | 60.2±5.9 | 56.8±5.3 | 54.9±4.2 | 51.2±5.7 |
营养干预过程中，实验组的体重呈现先下降后升高的趋势，且整体变化较小；而对照组则呈现逐渐下降的趋势，干预3周后，体重下降了约9kg。所以与肠外营养相比，本发明可以维持急性胰腺炎患者的体重。
氨基酸型全营养配方食品对患者的白蛋白和前白蛋白的影响如表13所示。
表13氨基酸型全营养配方食品对患者的白蛋白和前白蛋白的影响
营养干预过程中，实验组和对照组的白蛋白均呈现逐渐增大的趋势，但两者没有显著差别。实验组第21d的前白蛋白含量与实验前相比显著升高(p<0.05)。说明本发明可以升高患者血清白蛋白含量，改善其营养状态。
氨基酸型全营养配方食品对患者的肿瘤坏死因子-α(TNF-α)、白细胞介素-6(IL-6)、C反应蛋白(CRP)以及T淋巴细胞总数的影响见表14。
表14氨基酸型全营养配方食品对患者炎症因子及淋巴细胞的影响
实验组和对照组的血清TNF-α、IL-6和CRP的水平均随着时间延长呈现降低的趋势，并且实验组的TNF-α、IL-6水平的下降趋势更加显著。实验组的CD4+/CD8+呈现逐渐增加的趋势，而对照组则呈现逐渐降低的趋势。所以本发明可以降低机体炎症反应，通过增加机体淋巴细胞数量增加机体免疫。
由上述动物试验和临床试验可知：本发明可以显著改善机体的营养状态，维持机体正常的生理功能。本发明可以显著降低急性胰腺炎患者的炎症反应状态，同时通过增加淋巴细胞数量来增加机体的免疫力，有助于改善患者的生活质量，也有助于患者的后期康复。
上述详细说明是针对本发明其中之一可行实施例的具体说明，该实施例并非用以限制本发明的专利范围，凡未脱离本发明所为的等效实施或变更，均应包含于本发明技术方案的范围内。
Claims (10)
1.一种氨基酸型全营养特殊医学用途配方食品，包括氨基酸、碳水化合物、脂肪、复合维生素、牛磺酸、左旋肉碱和复合矿物质。
2.根据权利要求1所述的配方食品，其特征在于，所述氨基酸型全营养特殊医学用途配方食品还包括口味调节剂，所述口味调节剂包括甜味剂、香精和酸度调节剂。
3.一种氨基酸型全营养特殊医学用途配方食品，其特征在于，包含以下营养成分：
4.根据权利要求3所述的配方食品，其特征在于，所述口味调节剂包括：
甜味剂 0.3～0.34g，
香精 0.75～0.92g，
酸度调节剂 0.15～0.20g。
5.根据权利要求1-4任一项所述的配方食品，其特征在于，所述氨基酸均为单体氨基酸，包括如下18种氨基酸：甘氨酸、L-丙氨酸、L-精氨酸、L-天门冬氨酸、L-盐酸半胱氨酸、L-谷氨酰胺、L-组氨酸、L-异亮氨酸、L-亮氨酸、L-盐酸赖氨酸、L-蛋氨酸、L-苯丙氨酸、L-脯氨酸、L-丝氨酸、L-苏氨酸、L-色氨酸、L-酪氨酸和L-缬氨酸；
所述18种氨基酸的含量优选如下：甘氨酸0.37～0.55g、L-丙氨酸0.47～0.71g、L-精氨酸0.70～1.06g、L-天门冬氨酸0.64～0.96g、L-盐酸半胱氨酸0.16～0.24g、L-谷氨酰胺1.18～1.76g、L-组氨酸0.22～0.32g、L-异亮氨酸0.76～1.14g、L-亮氨酸1.52～2.38g、L-盐酸赖氨酸0.58～0.86g、L-蛋氨酸0.18～0.28g、L-苯丙氨酸0.47～0.71g、L-脯氨酸0.45～0.67g、L-丝氨酸0.27～0.41g、L-苏氨酸0.37～0.55g、L-色氨酸0.12～0.18g、L-酪氨酸0.08～0.12g和L-缬氨酸0.76～1.14g。
6.根据权利要求1-4任一项所述的配方食品，其特征在于，所述碳水化合物来源于麦芽糊精、玉米淀粉中的一种或者两种；
所述脂肪包括红花油和亚麻籽油，所述红花油和亚麻籽油的重量比为(1～2.5)∶1。
7.根据权利要求1-4任一项所述的配方食品，其特征在于，所述复合维生素包括：维生素A、维生素D、维生素E、维生素K、维生素B1、维生素B2、维生素B6、维生素B12、烟酸、叶酸、泛酸、维生素C、生物素和胆碱；
所述复合给生素中各组分的含量优选如下：维生素A182.4～456μg RE、维生素D2.42～4.54μg、维生素E2.4～6mgα-TE、维生素K20～40μg、维生素B1 0.36～0.68mg、维生素B2 0.41～0.77mg、维生素B6 0.48～0.90mg、维生素B12 1.44～2.70μg、烟酸4.8～9mg、叶酸86～180μg、泛酸2.4～4.5mg、维生素C17～60mg、生物素72～135mg和胆碱64～150mg。
8.根据权利要求1-4任一项所述的配方食品，其特征在于，所述复合矿物质包括：钠、钾、铜、镁、铁、锌、锰、钙、磷、碘、硒、铬和钼；
所述复合矿物质中各组分的含量优选如下：钠290～420mg、钾342～540mg、铜240～420μg、镁56.4～91.6mg、铁2.8～4.5mg、锌2.70～4.06mg、锰240～360μg、钙165～240mg、磷125～180mg、碘20.8～35.2μg、氯80～220mg、硒10.4～15.6μg、铬14.4～21.6μg和钼16～24μg。
9.根据权利要求1所述的配方食品，其特征在于，所述的配方食品被制备成合适服用的制剂形式，所述制剂选自散剂、颗粒剂、胶囊剂、片剂和乳剂中的一种。
10.根据权利要求1所述的配方食品，其特征在于，所述配方食品适用于进食受限、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，尤其是重症代谢障碍及胃肠道功能障碍的病人的肠内营养支持。
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