CN105685973B - 一种肠内营养剂 - Google Patents
一种肠内营养剂 Download PDFInfo
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- CN105685973B CN105685973B CN201610078824.XA CN201610078824A CN105685973B CN 105685973 B CN105685973 B CN 105685973B CN 201610078824 A CN201610078824 A CN 201610078824A CN 105685973 B CN105685973 B CN 105685973B
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Abstract
本发明提供了一种肠内营养剂，用于炎症性肠病的治疗。包含按质量百分含量计的下列组分：碳水化合物52%～70%，蛋白质14%～20%，脂肪10%～30%，维生素及矿物质2%～3%。本发明制备的肠内营养剂具有调节肠胃功能作用，可用于治疗炎症性肠病尤其是克恩病，诱导缓解，预防复发。
Description
技术领域
本发明为一种肠内营养制剂，用于炎症性肠病的治疗，尤其用于克恩病的治疗：诱导缓解，预防复发。
背景技术
炎症性肠病（inflammatory bowel disease，IBD）专指病因未明的炎症性肠病(idiopathic inflammatory bowel disease)，包括溃疡性结肠炎（ulcerative colitis，UC）和克罗恩病（Crohn's disease，CD）。CD是一种病因不清的全消化道慢性炎性肉芽肿性疾病，CD的发病率在世界范围内呈逐年升高趋势，在我国呈迅速上升趋势。CD发病机制不清楚，高糖、高脂、不合理的蛋白饮食及食物添加剂是促发因素。CD具有慢性迁延性，常伴发肛瘘，肠瘘、腹腔脓肿，肠道狭窄甚至梗阻，反复手术致短肠综合征等。由于纳差、厌食导致进食减少，腹痛、腹泻致营养在肠道丢失增多，肠道溃疡吸收减少，疾病活动消耗增加及药物的影响，CD患者的营养不良发生率高达50%-80%，约1/3的青少年患者生长发育迟缓。营养不良不但造成患者生活质量下降，妨碍溃疡愈合、增加感染并发症的发生率和死亡率，还严重影响药物的疗效。我们对克罗恩病患者进行了体成分分析，活动期患者普遍存在能量-蛋白质营养不良，而且患者瘦体质缺乏比体脂缺乏更严重，维生素和矿物质不足，尤其是铁和维生素D缺乏，缺铁导致贫血、疲劳；维生素D缺乏导致钙的吸收和沉积障碍，免疫功能的低下。
目前克罗恩病尚无特异性治疗手段，已有的治疗手段包括美沙拉嗪、糖皮质激素、免疫抑制剂（如硫唑嘌呤、沙利度胺）、生物制剂（如类克、阿达木等）可以不同程度诱导缓解，但复发率、并发症发生率及药物副作用居高不下。
全肠内营养（exclusive enteral nutrition，EEN）治疗在CD治疗已经作为一种基础治疗，在儿童是首选治疗措施。全肠内营养治疗克罗恩病，即患者通过口服或管饲服用肠内营养剂，除了水分不再进食任何其他的食物，持续8-12周，期间监测患者的症状、体征、血沉、C-反应蛋白、白蛋白等炎症、营养相关指标，观察患者的治疗反应，通过大肠镜、CTE、胶囊内镜检查明确肠道内粘膜的愈合情况。肠内营养治疗不仅可以改善患者的营养，还可以诱导缓解，促进肠道溃疡的黏膜愈合。每日服用半量的肠内营养剂可以维持缓解，预防复发。现有用于治疗克罗恩病的几种常用肠内营养制剂如下：1.安素：碳水化合物为麦芽糊精37%，玉米糖浆37%,蔗糖26%，缺点为双糖比例过高，流行病学调查显示精加工的糖与克罗恩病发病和活动有关；脂肪为玉米油，含亚麻酸较少，无中链脂肪酸；蛋白为酪蛋白86%，大豆蛋白14%，酪蛋白是一种大分子蛋白质，消化吸收慢，尤其在肠道存在病变情况下更加难以消化吸收；维生素和矿物质为常规含量；2.瑞素：碳水化合物为麦芽糊精，无其他调节肠道菌群和免疫的成分；蛋白为酪蛋白和大豆蛋白，酪蛋白难以消化吸收；脂肪为大豆油和中链脂肪酸，亚油酸含量较少；维生素和矿物质为常规含量；3.百普素：碳水化合物为麦芽糊精、蔗糖、少量乳糖，乳糖易导致腹泻；脂肪为大豆油和中链脂肪酸，亚油酸含量较少；蛋白为水解乳清蛋白，主要成分为短肽和氨基酸，水解乳清蛋白虽然能提供丰富的氨基酸，但缺乏乳清蛋白的生理调节作用；维生素和矿物质为常规含量。以上制剂均没有针对性强化补充铁和维生素D。
本发明者对上述市售的肠内营养剂进行了研究，发现这些肠内营养剂均为通用型制剂，用于治疗克罗恩病或难以消化吸收，或易腹泻，或缺乏有效的免疫调节的成分甚至可能促进炎症发展，总体有效率约60-80%，黏膜愈合率约60-70%。因此迫切需要一种适应克罗恩病特点的肠内营养制剂，以更快更高效的诱导疾病缓解，预防复发。
溃疡性结肠炎是一种病因不明的直肠和结肠慢性非特异性炎症性疾病，病变主要局限于大肠黏膜与黏膜下层。临床表现为腹痛、腹泻、粘液脓血便，病程迁延反复。腹痛、腹泻致营养物质丢失增多，肠道病变致吸收面积减少，患者也存在程度不等的营养不良，目前研究认为肠内营养制剂虽然对溃疡性结肠炎患者无治疗作用，但是仍然需要给予营养支持。
发明内容
本发明旨在提供一种肠内营养剂，能够快速高效诱导克恩病缓解，维持缓解，预防复发。同时，也可以作为溃疡性结肠炎患者的营养补充剂。
本发明所提供的一种肠内营养剂，其特征在于包含按质量百分含量计的下列组分：碳水化合物52%～70%，蛋白质14%～20%，脂肪10%～30%，维生素及矿物质2%～3%。
所述的肠内营养剂,碳水化合物优选57%～65%,蛋白质优选16%～19%，脂肪优选15%～25%，维生素及矿物质2%～3%。
所述的肠内营养剂，碳水化合物组分为麦芽糊精、大豆多糖和抗性糊精，碳水化合物各组分质量百分比为麦芽糊精85%～95%，大豆多糖0%～15%，抗性糊精0～15%。
所述的肠内营养剂，蛋白质组分为乳清蛋白、大豆蛋白和短肽，蛋白质各组分质量百分比为乳清蛋白35%～70%、大豆蛋白0%～30%、短肽20%～35%。
所述的肠内营养剂，脂肪为长链脂肪酸、中链脂肪酸，其中长链脂肪酸为植物油和鱼油；中链脂肪酸来自为椰子油或棕榈仁油。脂肪各组分质量百分比为植物油40%～60%、鱼油0%～15%，中链脂肪酸25%～55%，其中植物油为菜籽油、花生油、大豆油、橄榄油、亚麻籽油或玉米油的两种或两种以上混合。更优选菜籽油为低芥酸菜籽油。
所述的肠内营养剂，维生素包含:维生素A、类胡萝卜素、维生素D、维生素E、维生素K、维生素B1、维生素B2、维生素烟酸、维生素泛酸、维生素B6、叶酸、维生素B12、生物素、维生素c、胆碱、牛磺酸、L-肉碱。
所述的肠内营养剂，矿物质包含:Na、K、Cl、Ca、P、Mg、Fe、Zn、Cu、Mn、F、Mo、Se、Cr、I。
所述的肠内营养剂，维生素D的质量份为每100g肠内营养剂含维生素D7～30ug。
所述的肠内营养剂，矿物质Fe的质量份为每100g肠内营养剂含Fe8～12mg。
所述的肠内营养剂，其它维生素及矿物质质量配比均为常规量，按照物料配比常识加入，没有特别要求。
优选的肠内营养剂，维生素及矿物质质量配比见下表（以100 g肠内营养剂计）
| 矿物质 | 每100g | 维生素 | 每100g |
| 钠(Na) | 330-460mg | A | 200-460ugRE |
| 钾(K) | 500-700mg | 类胡萝卜素 | 0.7-0.930mg |
| 氯(Cl) | 350-570mg | D | 7-30ug |
| 钙(Ca) | 200-350mg | E | 3.0-6mgα-TE |
| 磷(P) | 175-330mg | K | 20-30ug |
| 镁(Mg) | 80-120mg | B1 | 0.35-1.1mg |
| 铁(Fe) | 8-12mg | B2 | 0.40-1.0mg |
| 锌(Zn) | 3.2-5.5mg | 烟酸 | 5.0-12mgNE |
| 铜(Cu) | 200-830ug | 泛酸 | 1.25-5.0mg |
| 锰(Mn) | 1.1-1.7mg | B6 | 0.40-2.5mg |
| 氟(F) | 0.40-0.5mg | 叶酸 | 100-130ug |
| 钼(Mo) | 25-45ug | B12 | 0.60-3.0ug |
| 硒(Se) | 15-25ug | 生物素 | 10.0-200ug |
| 铬(Cr) | 7-30ug | C | 30-100mg |
| 碘(I) | 30-120ug | 胆碱 | 120-170mg |
| 牛磺酸 | 20-30mg | ||
| L-肉碱 | 25-30mg |
所述的肠内营养剂，还包括药学上可接受的赋形剂。可以配置成混悬液、片剂、粉剂等不同的剂型。
所述的肠内营养剂粉剂制备方法为：将脂肪、维生素A、D、E混合得到乳化液，然后将乳化液物化成液滴喷入到含有粉末包埋物料的喷雾干燥设备中进行干燥，再经过筛分得到脂肪粉。然后将其余各组分加入到三维混合器中，混合30分钟，混匀后上粉剂全自动包装机，铝箔包装，每袋400克。
所述的肠内营养剂混悬液制备方法为：制备时添加辅料可溶性膳食纤维质量份比1%～3%、羟丙基甲基纤维素质量份比1%～2%。首先将蛋白质加入80-100ml水中，加入水溶性抗氧化剂，充分溶解搅拌成均质得浆体1；将脂肪、维生素A、D、E加热至40-60℃，加入油溶性抗氧化剂，充分混匀成均质得浆体2；将碳水化合物、水溶性维生素、矿物质加入300ml水中，充分溶解混匀得浆体3；将浆体1和2混合，高速搅拌混匀，加热至50-70℃，加入浆体3，将羟丙基甲基纤维素、可溶性膳食纤维加入，用适量的纯化水定容至500ml，高速混匀，得到乳化液；将乳化液过100-120目筛，25-35kpa高压均质两次，得到均匀稳定乳化液，灭菌处理后灌装，每袋500ml。
所述的肠内营养剂片剂制备方法为：将脂肪、维生素A、D、E混合得到乳化液，然后将乳化液物化成液滴喷入到含有粉末包埋物料的喷雾干燥设备中进行干燥，再经过筛分得到脂肪粉。然后将质量百分比1%～4%赋形剂甲壳胺及其余组分加入到三维混合器中，混合30分钟，混匀后，用压片机直接压片，每片10- 12.5g，每袋 8-10片，成品包装。
，所述的肠内营养剂，可用于治疗炎症性肠病，尤其用于克罗恩病（CD）的治疗和预防复发。
本发明的碳水化合物为麦芽糊精、大豆多糖和抗性糊精。麦芽糊精主要成分为糊精并含有多聚糖、四糖或四糖以上的低聚糖，含有少量的麦芽糖和葡萄糖，具有易消化吸收，稳定性好，难以变质的特性，过高的双糖易导致代谢紊乱，降低机体免疫功能，促进克罗恩病的发病和活动。大豆多糖主要成分为半乳糖、***糖、鼠李糖、海藻糖、木聚糖、葡萄糖等，膳食纤维含量高达80％以上，完全溶解于水中，具有促进双歧杆菌增殖、调节肠胃功能作用，同时还是一种高性能的蛋白乳化稳定剂。抗性糊精由淀粉加工而成的葡聚糖混合物，抗性糊精具有低热量、水溶性好，胃肠耐受性好等特性，能够促进肠道有益菌的增殖、降低致病菌的繁殖，调节局部免疫功能。本发明的碳水化合物组成有利于克罗恩病的康复。
本发明的蛋白质组成为乳清蛋白、大豆蛋白、短肽。乳清蛋白成分利用率高，易吸收，易耐受；乳清蛋白含α一乳球蛋白、α-乳白蛋白、乳铁蛋白、乳过氧化物酶、生长因子，α一乳球蛋白、α-乳白蛋白是必需氨基酸和支链氨基酸的极好来源，α-乳白蛋白也是唯一一种能结合钙的乳清蛋白，乳铁蛋白具有较高的生物活性，包括：抗菌性，抑制游离基形成、调节人体铁质转移、促进细胞生长并提高免疫能力、促进双歧杆菌增殖，并可作为抗氧化剂等，乳过氧化物酶能杀死微生物和细菌。乳清蛋白含有大量生长因子，有利于肠道疾病的治疗和创面修复。乳清蛋白的氨基酸构成中亮氨酸、异亮氨酸等支链氨基酸含量丰富，利于肌肉的合成及延缓中枢疲劳；富含大量的含硫氨基酸，其能维持人体内抗氧化剂的水平，并在细胞***时稳定DNA；赖氨酸和精氨酸含量较高，会刺激合成代谢激素或肌肉生长刺激因子的分泌与释放，因而刺激肌肉生长和机体脂肪降低；富含谷氨酸，能合成丰富的谷氨酰胺，谷氨酰胺是肠道粘膜细胞代谢必需的营养物质，有利于维持肠粘膜结构完整。乳清蛋白的营养价值是最高的，它的蛋白质效价、生物效价和蛋白质净利用率均优于酪蛋白。但是水解乳清蛋白只能提供氨基酸和短肽，缺乏乳清蛋白的生理调节作用。大豆蛋白含有丰富的支链氨基酸，利于患者瘦体质的恢复，又具有较少的免疫原性。短肽可以直接吸收、易耐受，在克罗恩病患者病变的肠道，有效吸收面积减少，短肽迅速吸收，有助于促进肠道粘膜细胞生长，降低细菌移位风险，维持肠道粘膜屏障，而且短肽口感好，没有氨基酸制剂的异味。三者组合可以快速改善患者的营养状况，调节免疫，利于疾病的恢复。
本发明制备的肠内营养剂，脂肪为长链脂肪酸、中链脂肪酸，其中长链脂肪酸为植物油和鱼油；中链脂肪酸来自为椰子油或棕榈仁油。植物油选用菜籽油、花生油、大豆油、橄榄油、亚麻籽油或玉米油的两种或两种以上混合。不同来源的植物油混合可以使包含的单不饱和脂肪酸，ω-3，ω-6脂肪酸达到合适的比例。橄榄油含有较高比例的单不饱和脂肪酸，亚麻油含有较多的ω-3脂肪酸。优选低芥酸菜籽油，低芥酸菜籽油含丰富的单不饱和脂肪酸（油酸）及亚油酸，还含有一定量的α－亚麻酸，脂肪酸比例比较平衡，人体对菜籽油的吸收率很高，可达99%。α-亚麻酸的含量为8.4%，远高于大豆油和玉米油。α-亚麻酸属于ω-3系列（或n-3系列）脂肪酸，α-亚麻酸及其衍生的长链多不饱和脂肪酸具有重要的生理病理功能，包括维持神经***功能，抗炎、减轻过氧化损伤，预防肿瘤，降脂等作用。中链脂肪酸易吸收，易氧化供能，利于改善肠道病变患者的能量代谢。鱼油富含EPA，DHA，能调节免疫反应，诱导炎症缓解。
炎症性肠病患者普遍缺乏铁和维生素D，因此强化补充铁和维生素D，维生素D每100g，7-30ug；Fe8-12mg，其他为常规量。
本发明制备的肠内营养剂，能够有效治疗炎症性肠病尤其对于克罗恩病，能够快速有效诱导缓解，维持缓解，预防复发，同时具有良好的胃肠道耐受性。克罗恩病患者由于疾病活动，能量需求较高，根据患者营养状况，一般给予30-35kcal/kg/d，蛋白质1.2-1.5g/kg/d。本发明制备的肠内营养剂，每400g瓶装或袋装可以提供体重60kg的患者一天的能量和蛋白质需求。每500ml的混悬液可以提供相当于一餐的热卡和蛋白质。片剂作为工作或外出时的能量补充，每10g片剂约为45kcal热量。
对于溃疡性结肠炎患者，按需服用。
本发明制备的肠内营养剂，适合所有人群，对1-10岁儿童、青年、成人、老年人都可使用。
具体实施例
下述实例仅用于阐述实现本发明的方法，不应理解为对本发明的限制。所有基于本发明思路做出的修改和变化都应归于本发明的保护范围。
实施例1
配制肠内营养剂混悬液，各组分质量为麦芽糊精60 g、抗性糊精5 g、乳清蛋白10g、短肽6g、低芥酸菜籽油9.2 g、橄榄油1.6g，中链脂肪酸6.2 g、维生素0.294g(其中维生素D，8.5 ug，维生素A ,430 ugRE;类胡萝卜素0.80mg、维生素E,5.2 mgα-TE;维生素K,24ug;维生素B1, 0.70mg;维生素B2, 0.8mg;烟酸8.0 mgNE、泛酸2.2mg、维生素B6,0.80mg;叶酸,110ug;维生素B12,0.6ug;生物素10ug、维生素C,100mg;胆碱120mg、牛磺酸25mg、L-肉碱30mg )、矿物质2.13g(其中Fe，9mg; Na330mg、K580mg、Cl420mg、Ca360mg、P320mg、Mg105mg、Zn4.8mg、Cu730ug、Mn1.5mg、F0.5mg、Mo30ug、Se30ug、Cr30ug、I40ug。)、可溶性膳食纤维1g，羟丙基甲基纤维素 1g。此包装每袋热量471kcal，含氮量为2.56g。
将乳清蛋白、大豆蛋白、短肽加入80-100ml水中，加入水溶性抗氧化剂，充分溶解搅拌成均质得浆体1；将菜籽油、中链脂肪酸、维生素A、D、E加热至40-60℃，加入油溶性抗氧化剂，充分混匀成均质得浆体2；将麦芽糊精、抗性糊精、水溶性维生素、矿物质加入300ml水中，充分溶解混匀得浆体3；将浆体1和2混合，高速搅拌混匀，加热至50-70℃，加入浆体3，将羟丙基甲基纤维素、可溶性膳食纤维加入，用适量的纯化水定容至500ml，高速混匀，得到乳化液；将乳化液过100-120目筛，25-35kpa高压均质两次，得到均匀稳定乳化液，灭菌处理后灌装，每袋500ml。
实施例2
配制肠内营养剂混悬液，各组分质量为麦芽糊精54.5g、大豆多糖2.5g、乳清蛋白9.5、大豆蛋白5.7g、短肽3.8g、玉米油4.3g，橄榄油3.5g、中链脂肪酸8.8g、鱼油2.9g、维生素0.27g(其中维生素D，15ug;维生素A ,450 ugRE;类胡萝卜素0.90mg、维生素E,5.7 mgα-TE;维生素K,24ug;维生素B1, 0.60mg;维生素B2, 0.74mg;烟酸8.2 mgNE;泛酸2.5mg;维生素B6,0.75mg;叶酸,100ug;维生素B12,0.9ug;生物素18.5ug、维生素C,45mg;胆碱160mg、牛磺酸20mg、L-肉碱25mg )、矿物质2.225g(其中Fe，8.5mg; Na350mg、K620mg、Cl450mg、Ca380mg、P310mg、Mg100mg、Zn4.5mg、Cu760ug、Mn1.2mg、F0.4mg、Mo25ug、Se25ug、Cr20ug、I60ug。)、可溶性膳食纤维1g，羟丙基甲基纤维素 1g。此包装每袋热量452.4kcal，含氮量为3.04g。
将乳清蛋白、大豆蛋白、短肽加入80-100ml水中，加入水溶性抗氧化剂，充分溶解搅拌成均质得浆体1；将玉米油、橄榄油、中链脂肪酸、鱼油、维生素A、D、E加热至40-60℃，加入油溶性抗氧化剂，充分混匀成均质得浆体2；将麦芽糊精、抗性糊精、水溶性维生素、矿物质加入300ml水中，充分溶解混匀得浆体3；将浆体1和2混合，高速搅拌混匀，加热至50-70℃，加入浆体3，将羟丙基甲基纤维素、可溶性膳食纤维加入，用适量的纯化水定容至500ml，高速混匀，得到乳化液；将乳化液过100-120目筛，25-35kpa高压均质两次，得到均匀稳定乳化液，灭菌处理后灌装，每袋500ml。
实施例3
制备肠内营养剂粉剂，各组分质量为麦芽糖糊精204g、抗性糊精12g、乳清蛋白56g、大豆蛋白8g、短肽16g、大豆油44g、亚麻籽油6g、中链脂肪酸50g、维生素0.469g(其中维生素D，60 ug，维生素A ,800ugRE;类胡萝卜素2.8mg、维生素E,12.0 mgα-TE;维生素K,80ug;维生素B1, 1.4mg;维生素B2, 1.6mg;烟酸20.0 mgNE、泛酸5.0mg、维生素B6,1.6mg;叶酸,400ug;维生素B12,2.4ug;生物素40ug、维生素C,120mg;胆碱120mg、牛磺酸80mg、L-肉碱100mg )、矿物质6.492g(其中Fe，40mg; Na1320mg、K2000mg、Cl1400mg、Ca800mg、P700mg、Mg320mg、Zn12.8mg、Cu800ug、Mn4.4mg、F1.6mg、Mo100ug、Se60ug、Cr28ug、I120ug)。此包装每袋热量2076kcal，含氮量为12.8g。
将大豆油、亚麻籽油、中链脂肪酸维生素A、D、E混合得到乳化液，然后将乳化液物化成液滴喷入到含有粉末包埋物料的喷雾干燥设备中进行干燥，再经过筛分得到脂肪粉。然后将其余各组分加入到三维混合器中，混合30分钟，混匀后上粉剂全自动包装机，铝箔包装，每袋400克。
实施例4
制备肠内营养剂片剂，各组分质量为麦芽糖糊精36.4g、大豆多糖7.8g、抗性糊精7.8g、乳清蛋白7g、大豆蛋白4g、短肽9g、花生油9g、亚麻籽油0.6g、中链脂肪酸15.4g，维生素0.227g(其中维生素D，7 ug，维生素A ,460 ugRE;类胡萝卜素0.86mg、维生素E,5.0 mgα-TE;维生素K,30ug;维生素B1, 0.65mg;维生素B2, 0.76mg;烟酸7.6 mgNE、泛酸3mg、维生素B6,0.70mg;叶酸,120ug;维生素B12,0.9ug;生物素19ug、维生素C,80mg;胆碱70mg、牛磺酸30mg、L-肉碱28mg )、矿物质2.1g(其中Fe，11mg; Na360mg、K560mg、Cl400mg、Ca330mg、P300mg、Mg95mg、Zn4.3mg、Cu700ug、Mn1.2mg、F0.6mg、Mo25ug、Se30ug、Cr20ug、I40ug)，甲壳胺1g。此包装每袋热量453.4kcal，含氮量为3.2g。
将大豆油、亚麻籽油、中链脂肪酸维生素A、D、E混合得到乳化液，然后将乳化液物化成液滴喷入到含有粉末包埋物料的喷雾干燥设备中进行干燥，再经过筛分得到脂肪粉。然后将其余组分加入到三维混合器中，混合30分钟，混匀后，用压片机直接压片，每片12.5g，每袋 8片，成品包装。
实施例5
制备肠内营养剂片剂，各组分质量为麦芽糖糊精66.5g、大豆多糖3.5g、乳清蛋白11.2g、短肽4.8g、玉米油4.0g、橄榄油0.5g、中链脂肪酸5.5g，维生素0.359g(其中维生素D，30ug，维生素A ,460 ugRE;类胡萝卜素0.930mg、维生素E,6 mgα-TE;维生素K,30ug;维生素B1, 1.1mg;维生素B2, 1.0mg;烟酸12.0 mgNE、泛酸5.0mg、维生素B6,2.5mg;叶酸,130ug;维生素B12,3.0ug;生物素200ug、维生素C,100mg;胆碱170mg、牛磺酸30mg、L-肉碱30mg )、矿物质2.095g(其中Fe，12mg; Na460mg、K700mg、Cl570mg、Ca350mg、P330mg、Mg120mg、Zn5.5mg、Cu830ug、Mn1.7mg、F0.5mg、Mo45ug、Se25ug、Cr30ug、I120ug)，甲壳胺2g。此包装每袋热量 427 kcal，含氮量为 2.56 g。
将玉米油、橄榄油、中链脂肪酸、维生素A、D、E混合得到乳化液，然后将乳化液物化成液滴喷入到含有粉末包埋物料的喷雾干燥设备中进行干燥，再经过筛分得到脂肪粉。然后将其余组分加入到三维混合器中，混合30分钟，混匀后，用压片机直接压片，每片 10g，每袋 10片，成品包装。
实施例6
此配方适合1-10岁儿童应用。
制备肠内营养剂粉剂，各组分质量为麦芽糖糊精260g、乳清蛋白35.2g、短肽28.8g、低芥酸菜籽油28g、橄榄油5g、中链脂肪酸36g、维生素2.04g(其中维生素D，48 ug，维生素A ,1760ugRE;类胡萝卜素2.8mg、维生素E,14.0 mgα-TE;维生素K,92ug;维生素B1,2mg;维生素B2, 2mg;烟酸11.0 mgNE、泛酸10.4mg、维生素B6,0.72mg;叶酸,120ug;维生素B12,1.0ug;生物素12ug、维生素C,45mg;胆碱60mg、牛磺酸15mg、L-肉碱25mg )、矿物质7g(其中Fe，32mg; Na1200mg、K2400mg、Cl480mg、Ca1600mg、P1080mg、Mg200mg、Zn9mg、Cu1200ug、Mn0.68mg、F1.0mg、Mo100ug、Se80ug、Cr40ug、I250ug。)。此包装每袋热量1917kcal，含氮量为10.24g。将低芥酸菜籽油、橄榄油、中链脂肪酸、维生素A、D、E混合得到乳化液，然后将乳化液物化成液滴喷入到含有粉末包埋物料的喷雾干燥设备中进行干燥，再经过筛分得到脂肪粉。然后将其余各组分加入到三维混合器中，混合30分钟，混匀后上粉剂全自动包装机，铝箔包装，每袋400克。
实验例
对服用肠内营养剂的患者进行试验研究
实验1
临床研究如下：活动期克罗恩病患者67例，其中男43例，女24例；根据克罗恩病活动指数（CDAI）分为轻度 (150～220)，中度(221～450)，重度(>450)。随机分为肠内营养剂（自制）（又名肠内营养炎症性肠病专用型）治疗组和安素治疗为对照组，两组在性别、年龄、CDAI差异无显著性。两组分别给予肠内营养剂（自制）和安素进行全肠内营养治疗12周，患者CDAI下降≥150为治疗有效，肠镜下溃疡愈合为黏膜愈合。两组治疗结果比较差异有显著性。（见表1）
表1肠内营养制剂和安素治疗组治疗克罗恩病效果比较
| 肠内营养剂（自制） | 安素组 | P | |
| 例数 | 32 | 35 | >0.5 |
| 男/女 | 22/11 | 21/13 | >0.5 |
| 年龄 | 31.8±4.9 | 32.3±5.2 | >0.5 |
| 轻/中/重 | 10/14/8 | 12/14/7 | >0.5 |
| 治疗有效率 | 93.8%（30/32） | 82.9%（29/35） | <0.5 |
| 黏膜愈合率 | 93.8%（30/32） | 77.1%（27/35） | <0.5 |
通过比较可知，自制肠内营养制剂治疗组较安素组，显著提高了克罗恩病治疗有效率及黏膜愈合率。
实验2
临床研究如下：活动期克罗恩病患者56例，其中男40例，女21例；根据克罗恩病活动指数（CDAI）分为轻度 (150～220)，中度(221～450)，重度(>450)。随机分为肠内营养炎症性肠病专用型治疗组和安素治疗为对照组，两组在性别、年龄、CDAI差异无显著性。两组分别给予肠内营养炎症性肠病专用型和瑞素进行全肠内营养治疗4周，患者CDAI下降≥150为治疗有效。两组治疗结果比较差异有显著性。（见表2）
表2肠内营养制剂治疗组和瑞素治疗组治疗克罗恩病效果比较
| 肠内营养剂（自制） | 瑞素组 | P | |
| 例数 | 32 | 24 | >0.5 |
| 男/女 | 22/11 | 18/10 | >0.5 |
| 年龄 | 31.8±4.9 | 30.3±5.4 | >0.5 |
| 轻/中/重 | 10/14/8 | 8/10/6 | >0.5 |
| 治疗有效率 | 90.6%（29/32） | 75%（18/24） | <0.5 |
通过比较可知，自制肠内营养制剂治疗组较瑞素组，显著提高了克罗恩病治疗有效率及黏膜愈合率。
实验3
临床研究如下：活动期克罗恩病患者51例，其中男35例，女16例；根据克罗恩病活动指数（CDAI）分为轻度 (150~220)，中度(221~450)，重度(>450)。随机分为肠内营养炎症性肠病专用型治疗组和安素治疗为对照组，两组在性别、年龄、CDAI差异无显著性。两组分别给予肠内营养炎症性肠病专用型和安素进行全肠内营养治疗4周，患者CDAI下降≥150为治疗有效。两组治疗结果比较差异有显著性。（见表3）
表3肠内营养制剂治疗组和百普素治疗组治疗克罗恩病效果比较
| 肠内营养剂（自制） | 百普素组 | P | |
| 例数 | 32 | 19 | >0.5 |
| 男/女 | 22/10 | 13/6 | >0.5 |
| 年龄 | 31.8±4.9 | 30.3±5.4 | >0.5 |
| 轻/中/重 | 10/14/8 | 7/9/3 | >0.5 |
通过比较可知，自制肠内营养制剂治疗组百普素组，显著提高了克罗恩病治疗有效率及黏膜愈合率。
Claims (7)
1.一种肠内营养剂，其特征在于包含按质量百分含量计的下列组分：
碳水化合物52%～70%，
蛋白质14%～20%，
脂肪10%～30%，
维生素及矿物质2%～3%；
其中碳水化合物组分为麦芽糊精、大豆多糖和抗性糊精，各组分质量百分比为麦芽糊精85%～95%，大豆多糖0%～15%，抗性糊精0%～15%；
其中蛋白质组分为乳清蛋白、大豆蛋白和短肽，各组分质量百分比为乳清蛋白35%～70%、大豆蛋白0%～30%、短肽20%～65%；
其中脂肪组分为长链脂肪酸和中链脂肪酸，其中长链脂肪酸为植物油和鱼油；中链脂肪酸来自椰子油或棕榈油。
2.根据权利要求1所述的肠内营养剂，脂肪各组分质量百分比为植物油40%～60%、鱼油0%～15%，中链脂肪酸25%～55%。
3.根据权利要求2所述的肠内营养剂，植物油为菜籽油、花生油、大豆油、橄榄油、亚麻籽油或玉米油的两种或两种以上混合。
4.根据权利要求3所述的肠内营养剂，菜籽油为低芥酸菜籽油。
5.权利要求1～4任一所述的肠内营养剂，还包括药学上可接受的赋形剂。
6.权利要求5所述的肠内营养剂为混悬液、片剂、粉剂。
7.权利要求1～6任一所述的肠内营养剂，在制备预防或治疗炎症性肠病药物中的应用。
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