CN113303467A - 一种适用于1~10岁脂代谢异常患儿的肠内营养粉剂及其制备方法 - Google Patents
一种适用于1~10岁脂代谢异常患儿的肠内营养粉剂及其制备方法 Download PDFInfo
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Abstract
本发明涉及一种适用于1~10岁脂代谢异常患儿专用型肠内营养粉剂及其制备方法,由下重量份的各组分组成,蛋白质10~25份,脂肪15.5份,碳水化合物54~69份,维生素0.05~0.15份,矿物质0.5~2.5份,左旋肉碱酒石酸盐0.01~0.03份,牛磺酸0.01~0.03份,水分2.0~4.0份。本发明的优点是:本品每100g供能455.5kcal,包含人体所需的六大营养素,不含膳食纤维,不含乳糖,有利于提高肠道耐受性。
Description
技术领域
本发明涉及一种肠内营养粉剂,具体涉及一种用于1~10岁脂代谢异常患儿的肠内营养粉剂及其制备方法。
背景技术
婴幼儿及儿童期是生长发育的关键时期,身高和体重增长的同时也伴随着器官的逐渐分化和机能的逐渐成熟,合理的膳食调配是维持机体良好的营养状况和健康发育的基础。一些疾病会导致营养摄入不足和(或)能量消耗增加,可能造成儿童营养不良,如婴幼儿及儿童期出现的家族性高乳糜微粒血症、经培门冬酶治疗急性淋巴细胞白血病患儿而引起的血脂水平急剧升高、小儿先天胆道闭锁术后、小儿胆囊炎、胆管炎以及小儿胰腺炎等疾病引发的脂质代谢障碍,在治疗的过程中需要严格控制长链脂肪酸摄入,减小对脂代谢器官尤其是对胰腺的刺激,以减少急性胰腺炎等并发症发生。患儿良好的营养状态与最佳的临床结局息息相关,合理的饮食干预是控制血浆甘油三酯水平,减少并发症和保证患儿正常生长发育的重要组成部分。
随着近年来对胃肠道结构和功能研究的深入,逐步认识到胃肠道不单纯是消化吸收器官,同时是重要的免疫器官。肠内营养(enteral nutrition,EN)支持是一种简便、安全、有效、经济的营养补给方式,有助于维持肠粘膜细胞结构与功能完整性,维持肠道固有菌丛生长,保证肠道的免疫及屏障作用,也更符合人的生理需求,肠内营养支持的临床作用越来越受到重视。对于上述疾病急需营养支持的患儿,尚存胃肠道功能的情况下,肠内营养支持应为首选营养支持途径。
家族性高乳糜微粒血症(Familial chylomicronemia syndrom,FCS),又称原发性高脂蛋白血症Ⅰ型,是一种罕见的常染色体隐性遗传病,发病率在百万分之一左右。该疾病主要是由于机体脂蛋白酯酶或载脂蛋白CⅡ缺乏或存在脂蛋白酯酶抑制剂所致,表现为患儿血液中的甘油三酯和乳糜微粒浓度升高,同时伴发急性胰腺炎、肝脾大及脂血性视网膜炎。疾病发病早,多在10岁之前发病,约有25%在婴儿期发病。患者体内的血液无法承受大量脂肪颗粒,容易出现各种急性胰腺炎等并发症,因此该类患儿在饮食方面禁止进食正常餐食,需长期限制长链脂肪酸的摄入量,以维持血浆中甘油三酯水平。2012年11月,欧盟委员会((European Commission,EC)批准了西方世界首个基因治疗药物Glybera修复基因缺陷,但其价格非常昂贵,超出一般家庭的经济负担。多项临床研究结果表明,低脂饮食疗法仍是该类患儿的首选。
急性淋巴细胞白血病(Acute lymphoblastic leukemia,ALL)是急性白血病的一种类型,是儿童最常见的恶性肿瘤,可占儿童白血病的70%以上。培门冬酶是治疗儿童急性淋巴细胞白血病的有效药物,在诱导缓解和延迟强化阶段大剂量密集使用,起到抑制肿瘤细胞生长的作用,从而提高ALL患儿的缓解率及无病生存。虽然培门冬酶是一种有效的抗白血病药物,但它也存在一定的副作用,如过敏反应、凝血异常、肝功能异常、胰腺炎等不良反应,其中最严重的不良反应是急性胰腺炎。培门冬酶可引起脂质代谢异常,主要是高胆固醇血症和高甘油三酯血症,明显升高的甘油三酯水平长期以来被认为是急性胰腺炎的危险因素,同时血液粘度升高会导致周围神经病变和间歇性中枢神经系统症状。因此对于使用培门冬酶治疗急性淋巴细胞白血病的儿童,需要采取相应措施控制甘油三酯和胆固醇水平,减小对胰腺及其它器官的刺激,降低并发症发病风险。目前,临床治疗方法主要是血浆置换以及服用纤维蛋白,对于饮食方面普遍建议低脂饮食。
对于患儿出现的脂质代谢障碍,需长期或短期限制饮食中的长链脂肪酸的含量,因而无法满足机体对营养物质正常的生理需求,将会出现以下问题:首先,患儿主要是通过限制食物种类及烹调方式限制脂肪摄入,这与家属营养相关知识掌握情况密切相关,患儿家长常常不能精确分辨长链甘油三酯含量高的食物,导致患儿病情加重;第二,限制长链脂肪酸的摄入极易导致患儿体内必需脂肪酸的缺乏,必需脂肪酸是人体需要而自身又无法合成的,单纯依靠外源性输入,必需脂肪酸缺乏可导致线粒体肿胀、细胞膜结构和功能改变以及膜的通透性和脆性增加,进而出现皮肤粗糙、视力模糊、外周神经炎等必需脂肪酸缺乏的症状;第三,脂肪摄入不足也会伴随着脂溶性维生素的缺乏,进而出现皮肤角化、佝偻病等脂溶性维生素缺乏症;由于儿童胃容量小,而脂肪酸体积小、能量密度大,对于儿童长期限制脂肪酸摄入易导致患儿能量摄入不足。婴幼儿及儿童时期正是机体生长发育的关键时期,如合并脂代谢异常及疾病负担,加之过分的饮食控制使得相关疾病的患儿成为营养不良的高危人群,急需全营养配方食品改善患儿的营养状况。
目前,市场现存的长链甘油三酯含量低的肠内营养粉剂主要包括立适康、力存、唯卡能、亚宝唯源等品牌的低脂型全营养粉,脂肪含量一般在1.7~2.5g/100g,主要来源于植物油,只能通过降低脂肪含量来减少长链脂肪酸的摄入,能量密度低,适用于10岁以上人群;另外,其维生素及矿物质的含量均依据成人营养需求添加,长期食用容易出现微量元素的过量或缺乏,不适用于临床患儿应用,因而尚缺乏1~10岁脂代谢异常患儿适用的肠内营养制剂。
中链甘油三酯(medium chain triglycerides,MCT),是碳链长度为8~12个的中链脂肪酸经甘油酯化形成的,天然存在于棕榈油、椰子油等食品和母乳中,是膳食脂肪的来源之一,因其特有的机体代谢方式及生物安全性受到越来越多的关注。MCT在机体中的代谢过程,首先在胃和十二指肠内被脂肪酶分解成甘油和中链脂肪酸(MCFA),在小肠内可不经胆汁乳化,在小肠粘膜上皮细胞以甘油和MCFA的形式吸收,直接通过小肠毛细血管进入门静脉,然后快速转移到肝内,在肝内线粒体迅速氧化代谢产能。MCT的特殊吸收代谢方式对临床一些疾病的营养治疗有非常重要意义,通常用于治疗脂类消化不良和吸收障碍的病人。MCT在营养治疗中只能替代部分长链甘油三酯,每日用量不超过40g,MCT的过量使用引起高渗性腹泻、酮血症及必需脂肪酸的缺乏。
因此,结合目前临床营养研究观察,本发明拟采用中链甘油三酯替代部分长链甘油三酯,研制出一款适用于1~10岁脂代谢异常患儿能量营养需求的肠内营养粉剂,以维持患儿经口进食的能量密度并减小对胰腺等脂质消化器官的刺激。
综上所述,为满足儿童生长发育需要以及临床营养治疗需求,本发明选用中链甘油三酯替代部分长链甘油三酯,脂肪含量远高于市面上的低脂全营养粉剂,可以在保证膳食能量密度的同时保证必需脂肪酸和脂溶性维生素的供给,有利于维持血浆甘油三酯水平。经营养素的重新调节配比,开发出适用于预防经培门冬酶治疗的急性淋巴细胞白血病患儿出现急性胰腺炎和高甘油三酯血症,以及家族性高乳糜微粒血症、先天性胆道闭锁、小儿胆囊炎、胆管炎、胰腺炎等需要遵循低脂饮食原则患儿的个性化肠内营养粉剂,为患儿提供均衡营养,改善患儿的营养状况,减少并发症发生。
发明内容
为弥补现有产品缺陷,本发明提供了一种用于1~10岁脂质代谢异常患儿专用的肠内营养粉剂,脂肪由ω-3、ω-6和中链甘油三酯组成,可以在维持食物能量密度的同时辅助治疗相关脂代谢的疾病,如家族性高乳糜微粒血症、经培门冬酶治疗急性淋巴细胞白血病患儿而引起的血脂急剧升高、小儿先天胆道闭锁术后、小儿胆囊炎、胆管炎以及胰腺炎等引发的高血脂、高胆固醇的症状,也可以减小对胰腺和胆囊的刺激,预防胰腺炎的发生。本发明需要在医生或营养师的指导下使用,可以单独食用也可以与其他食物配合食用,可鼻饲也可经口喂养,其能量和营养成分可以满足1~10岁人群正常生长发育需求。本发明提供一种适用于脂代谢异常患儿的肠内营养粉剂,本发明的技术方案是:
一种适用于1~10岁脂代谢异常患儿肠内营养粉剂,由以下重量份的各组分组成,蛋白质10~25份,脂肪15.5份,碳水化合物54~69份,维生素0.05~0.15份,矿物质0.5~2.5份,左旋肉碱酒石酸盐0.01~0.03份,牛磺酸0.01~0.03份,水分2.0~4.0份。
优选为:蛋白质14份,脂肪15.5份,碳水化合物65份,维生素0.05~0.15份,矿物质0.5~2.5份,左旋肉碱酒石酸盐0.02份,牛磺酸0.02份,水分3.0份。
所述碳水化合物为麦芽糊精;所述的蛋白质为乳清蛋白;所述的脂肪由ω-3、ω-6和中链甘油三酯组成,且ω-3:ω-6:MCT的重量百分比为2.5%~3.2%:10%~13%:84%~87%。
所述维生素重量配比如下:维生素A0.0004-0.001份,维生素B10.0003-0.003份,维生素B2 0.0003-0.003份,烟酸0.0016-0.005,泛酸0.0016-0.005份,维生素B6 0.0003-0.003份,生物素0.000001-0.000015份,叶酸0.00003-0.00014份,维生素B12 0.0000009-0.000002份,维生素C 0.04-0.2份,维生素D3 0.000006-0.000017份,维生素E 0.003-0.07份,维生素K1 0.00002-0.00003份;
所述矿物质重量配比如下:钾0.4-0.6份,钙0.4-0.6份,钠0.15-0.46份,磷0.2-0.8份,锰0.000006-0.0001份,镁0.035~0.15份,铁0.0058~0.01份,锌0.0022~0.008份,铜0.00016-0.0008份,碘0.00003-0.00007份,钼0.00003-0.00013份,硒0.00001-0.00006份,铬0.00001-0.000025。
一种制备适用于1~10岁脂代谢异常患儿肠内营养粉剂的方法,包括以下步骤:
(1)按照配比,称取各组分,将各组分形成的混合物置入搅拌机中,加入50~60℃纯净水,通入惰性气体氮气,在500-800rpm的转速下进行搅拌10~15min直至充分溶解混匀得到第一混合浆体;所述步骤(1)中的混合物与纯净水的重量比为1:3~5;
(3)将步骤(1)中所得第一混合浆体转入高压均质机中均质,均质温度40~50℃,均质压力为15~20kPa,均质两次后过100~120目筛,得到第二混合浆体进行贮存备用,贮存备用时保存温度在10℃以下,转速80~100rpm,保存时间不超过10h;
(4)将步骤(3)所得的第二混合浆体在85~95℃高温下短时杀菌,杀菌时间15~20s,得到第三混合浆体;
(5)将步骤(4)中得到的无菌的第三混合浆体进行喷雾干燥,喷雾干燥进风为干燥的无氧气体,风速为7.00~7.30m/s,进风温度160-185℃,排风温度75-85℃,喷雾干燥至水分在8%~12%;
(6)将步骤(5)中得到的粉末放入流化床,流化床分为三个区段,分别是从下方吹入清洁的30~40℃温空气、50~65℃的热空气和0~5℃的冷空气,潮湿的粉末首先富聚成稳定的团粒,经温空气和热空气干燥至水分含量在2%~4%,后吹入冷空气将成品冷却,吹出细分后过80-100目筛;
(7)将所得的均匀、富聚性稳定的团粒真空或充氮独立罐装,制得所需肠内营养粉剂。
本发明的优点是:本品每100g供能455.5kcal,包含人体所需的六大营养素,能量配比为蛋白质8.8%~22.0%,脂肪30.6%,碳水化合物47.4%~60.6%,不含膳食纤维,不含乳糖,有利于提高肠道耐受性。儿童胃的容量相对较小,需要的膳食能量密度高,因此其膳食脂肪的供能比高于成人。
本发明中脂肪主要是中链甘油三酯和必需脂肪酸,不含反式脂肪酸,供能比为30.6%。特别添加中链甘油三酯(MCT),占总脂肪酸含量的84%~87%。
MCT的脂肪酸碳原子数目少,分子量小,有一定的水溶性,吸收后可直接经门静脉进入肝脏,在肝内不参与脂肪的合成,能迅速被组织摄取产生能量。MCT不刺激胰液及胆盐的分泌,快速氧化供能,有利于减轻患儿胰腺、胆囊负担,维持血浆中甘油三酯浓度。添加ω-3脂肪酸(为必需脂肪酸),它的碳链可被延长为更长链的多不饱和脂肪酸,如EPA和DHA,具有降低血胆固醇和甘油三酯,降低血液黏度的作用。添加ω-6脂肪酸(为必需脂肪酸),具有扩张血管的作用,还可刺激棕色脂肪组织,起到防止肥胖的作用。
蛋白质选用乳清蛋白,乳清蛋白易于消化吸收,具有高生物价、高消化率、高蛋白质功效比和高利用率的特点,是公认的人体优质蛋白质补充剂之一,可减轻患儿的胃肠道负担,同时保证优质蛋白质的供应。
碳水化合物选用麦芽糊精,不含乳糖,具有良好的肠道耐受性。麦芽糊精不仅为机体提供能量,还具有无异味,易消化,溶解性好、价格低廉等优势。麦芽糊精也可以抑制肠内细菌发酵,具有防治腹泻的作用,适宜作病人和婴幼儿食品的基础原料,同时也适用于糖尿病患者。
本发明采用强锌配方,并特别添加牛磺酸。锌对婴幼儿及儿童生长发育和机体代谢发挥着重要作用,锌缺乏常会出现味觉下降、厌食、异食癖,嗜睡、面色苍白,抵抗力差而易患各种感染性疾病。牛磺酸(Taurine,Tau)是动物体内一种结构简单的含硫氨基酸,也是人体的条件必需氨基酸,与幼儿、胎儿的中枢神经及视网膜等的发育有密切的关系,可以调节脂类的消化与吸收。
左旋肉碱酒石酸盐是左旋肉碱的稳定形态,其作用和效果与左旋肉碱相似,左旋肉碱是脂肪代谢过程中的一种关键物质,能够促进脂肪酸进入线粒体氧化分解。当体内缺乏左旋肉碱时,会引起长链脂肪酸氧化障碍,也会导致脂肪在肝脏、血管中堆积。增加左旋肉碱的摄入,可以调节脂肪代谢,促进脂肪的氧化。
本发明为等渗配方,渗透压300mmol/L H2O,不容易引起腹胀、腹泻及其他肠道反应,患者肠道耐受性好。本发明强化维生素和矿物质添加,依据《中国居民膳食营养素参考摄入量(2013版)》和《特殊医学用途配方食品通则》(GB 29922-1013)要求添加多种维生素和矿物质,可防治因维生素和矿物质缺乏导致的多种疾病。本发明为粉剂型肠内营养制剂,易于保存,容易调整冲调的量及渗透压,使用灵活,可口服,可通过消化道管饲。
附图说明
图1是本发明的制备方法流程示意图。
具体实施方式
下面结合具体实施例来进一步描述本发明,本发明的优点和特点将会随着描述而更为清楚。但这些实施例仅是范例性的,并不对本发明的范围构成任何限制。本领域技术人员应该理解的是,在不偏离本发明的精神和范围下可以对本发明技术方案的细节和形式进行修改或替换,但这些修改和替换均落入本发明的保护范围内。
为了更好地了解本发明,下面结合具体实施方式对本发明进行进一步描述,但本发明绝不仅限于实施例。
实施例1:每100g提供能量455.5kcal,能量配比为蛋白质供能22.0%,碳水化合物47.4%,脂肪30.6%,脂肪由ω-3、ω-6和中链甘油三酯(MCT)组成,ω-3:ω-6:MCT的重量百分比为2.5%~3.2%:10%~13%:84%~87%。该实施例中蛋白质含量较高,有利于纠正患儿蛋白水平,维持急性淋巴细胞白血病患儿化疗期间的氮平衡和能量供应,有利于缓解化疗期间出现的不良反应,适用于1~10岁急性淋巴细胞白血病患儿围培门冬酶化疗期服用。
该种适用于1~10岁脂代谢异常患儿肠内营养粉剂的制备方法,包括以下步骤:
(1)按照配比,称取各组分,将各组分形成的混合物置入搅拌机中,加入50℃纯净水,通入惰性气体氮气,在500rpm的转速下进行搅拌10~15min直至充分溶解混匀得到第一混合浆体;所述步骤(1)中的混合物与纯净水的重量比为1:3;
(3)将步骤(1)中所得第一混合浆体转入高压均质机中均质,均质温度40℃,均质压力为15kPa,均质两次后过100目筛,得到第二混合浆体进行贮存备用,贮存备用时保存温度在10℃以下,转速80rpm,保存时间不超过10h;
(4)将步骤(3)所得的第二混合浆体在85℃高温下短时杀菌,杀菌时间15s,得到第三混合浆体;
(5)将步骤(4)中得到的无菌的第三混合浆体进行喷雾干燥,喷雾干燥进风为干燥的无氧气体,风速为7.00m/s,进风温度160℃,排风温度75℃,喷雾干燥至水分在8%;
(6)将步骤(5)中得到的粉末放入流化床,流化床分为三个区段,分别是从下方吹入清洁的30℃温空气、50℃的热空气和0℃的冷空气,潮湿的粉末首先富聚成稳定的团粒,经温空气和热空气干燥至水分含量在2%,后吹入冷空气将成品冷却,吹出细分后过80目筛;
(7)将所得的均匀、富聚性稳定的团粒真空或充氮独立罐装,制得所需肠内营养粉剂。
实施例2:此实施例每100g提供能量455.5kcal,蛋白质供能比为12.3%,碳水化合物57.1%,脂肪30.6%,脂肪由ω-3、ω-6和中链甘油三酯(MCT)组成,ω-3:ω-6:MCT的重量百分比为2.5%~3.2%:10%~13%:84%~87%。该实施例中各宏量营养素配比均衡、合理,符合1~10岁人群能量及营养素需求,适用于1~10岁患儿培门冬酶化疗停药后过渡到正常饮食阶段食用,同时也适用于脂代谢异常患儿长期服用。
该种适用于1~10岁脂代谢异常患儿肠内营养粉剂的制备方法,包括以下步骤:
(1)按照配比,称取各组分,将各组分形成的混合物置入搅拌机中,加入55℃纯净水,通入惰性气体氮气,在600rpm的转速下进行搅拌12min直至充分溶解混匀得到第一混合浆体;所述步骤(1)中的混合物与纯净水的重量比为1:4;
(3)将步骤(1)中所得第一混合浆体转入高压均质机中均质,均质温度45℃,均质压力为18kPa,均质两次后过110目筛,得到第二混合浆体进行贮存备用,贮存备用时保存温度在10℃以下,转速90rpm,保存时间不超过10h;
(4)将步骤(3)所得的第二混合浆体在85~95℃高温下短时杀菌,杀菌时间18s,得到第三混合浆体;
(5)将步骤(4)中得到的无菌的第三混合浆体进行喷雾干燥,喷雾干燥进风为干燥的无氧气体,风速为7.2m/s,进风温度175℃,排风温度80℃,喷雾干燥至水分在10%;
(6)将步骤(5)中得到的粉末放入流化床,流化床分为三个区段,分别是从下方吹入清洁的35℃温空气、55℃的热空气和3℃的冷空气,潮湿的粉末首先富聚成稳定的团粒,经温空气和热空气干燥至水分含量在3%,后吹入冷空气将成品冷却,吹出细分后过90目筛;
(7)将所得的均匀、富聚性稳定的团粒真空或充氮独立罐装,制得所需肠内营养粉剂。
临床案例1患儿鲁某,男,2岁9个月,身高92cm,体重14kg,发热1周,发现血异常4天,全身皮肤粘膜苍黄。结合患儿症状、体征及辅助检查,诊断血象异常原因为急性淋巴细胞白血病(B,低危)。于培门冬酶化疗前3日予以低脂饮食指导,当日生化检查结果:血红蛋白118g/L,总蛋白48.86g/L,白蛋白28.75g/L,前白蛋白156.1mg/L,甘油三酯2.35mmol/L,总胆固醇4.39mmol/L。
营养治疗上,经口给予实施例1中的肠内营养粉剂治疗,其特点是该实施例中蛋白质含量较高,有利于纠正患儿蛋白水平,维持急性淋巴细胞白血病患儿化疗期间的氮平衡和能量供应,有利于缓解化疗期间出现的不良反应,适合该患者的病情。第1天嘱患儿家属温水冲调后少量多次服用,1天后随访,患儿口服后无恶心、呕吐、腹胀现象,耐受良好。
营养治疗1周后,总蛋白50.98g/L,白蛋白30.12g/L,前白蛋白190.1mg/L,甘油三酯5.57mmol/L,总胆固醇4.95mmol/L,电解质指标无异常,肾功能、淀粉酶、转氨酶指标浮动均在正常范围内,血凝指标轻微异常。化疗后第6天,由实施例1过渡到实施例2的肠内营养粉,患儿耐受良好。营养治疗2周后随访,患者化疗效果良好,复查甘油三酯和胆固醇水平均在正常范围内,未出现胰腺炎相关症状,总蛋白52.16g/L,白蛋白32.35g/L,前白蛋白202.1mg/L,无其他新的不良反应出现,营养治疗效果理想,可逐步过渡到正常饮食。
临床案例2患儿董某,男,5岁,患儿因“左足疼痛2月余”入院,诊断为恶行淋巴瘤,身高118cm,体重22kg,血红蛋白85g/L,,血小板73×109/L,总蛋白55.76g/L,白蛋白34.87g/L,胆碱酯酶5328.00U/L,谷丙转氨酶28.00U/L,谷草转氨酶30.00U/L。临床计划给予培门冬酶化疗,于用药前3天,用药中及停药后的5天内给予实施例1中全营养配方饮食,患儿耐受性良好。后服用实施例2营养粉,2周后随访,患儿状况良好,复查甘油三酯在正常范围内,未出现胰腺炎相关症状,肠内营养粉剂适当减量,并给予相应的低脂饮食指导,禁食油炸、油煎、动物内脏、肥肉、动物籽等。
实施例3:此实施例营养粉每100g提供455.5kcal能量,其中蛋白质供能比为8.8%,碳水化合物60.1%,脂肪30.6%,脂肪由ω-3、ω-6和中链甘油三酯(MCT)组成,其中ω-3:ω-6:MCT的重量百分比为2.5%~3.2%:10%~13%:84%~87%。本实施例中碳水化合物含量丰富,可有效避免MCT迅速代谢氧化形成大量酮体,引起酮血症。蛋白质含量偏低,可满足1~10岁人群基本的蛋白质需求,维持氮平衡,同时蛋白质含量低,有利于减小对胰腺的刺激,减少胰液的分泌,适用于1~10岁急性胰腺炎患儿病情稳定后启用。
该种适用于1~10岁脂代谢异常患儿肠内营养粉剂的制备方法,包括以下步骤:
(1)按照配比,称取各组分,将各组分形成的混合物置入搅拌机中,加入60℃纯净水,通入惰性气体氮气,在800rpm的转速下进行搅拌15min直至充分溶解混匀得到第一混合浆体;所述步骤(1)中的混合物与纯净水的重量比为1:5;
(3)将步骤(1)中所得第一混合浆体转入高压均质机中均质,均质温度50℃,均质压力为20kPa,均质两次后过120目筛,得到第二混合浆体进行贮存备用,贮存备用时保存温度在10℃以下,转速100rpm,保存时间不超过10h;
(4)将步骤(3)所得的第二混合浆体在95℃高温下短时杀菌,杀菌时间20s,得到第三混合浆体;
(5)将步骤(4)中得到的无菌的第三混合浆体进行喷雾干燥,喷雾干燥进风为干燥的无氧气体,风速为7.30m/s,进风温度185℃,排风温度85℃,喷雾干燥至水分在12%;
(6)将步骤(5)中得到的粉末放入流化床,流化床分为三个区段,分别是从下方吹入清洁的40℃温空气、65℃的热空气和5℃的冷空气,潮湿的粉末首先富聚成稳定的团粒,经温空气和热空气干燥至水分含量在4%,后吹入冷空气将成品冷却,吹出细分后过100目筛;
(7)将所得的均匀、富聚性稳定的团粒真空或充氮独立罐装,制得所需肠内营养粉剂。
临床案例1患儿李某,男,2岁,身高62.0cm,体重11.2kg,于出生后60d诊断为家族性高乳糜微粒血症,本次因腹痛、急性胰腺炎发作入院。患儿空腹血浆中有乳糜微粒,4℃静置后可见奶油盖层。检查结果显示:血清总蛋白48.0g/L,血清白蛋白30.0g/L,高密度脂蛋白胆固醇2.08mmol/L,低密度脂蛋白胆固醇0.25mmol/L,甘油三酯93.70mmol/L。
患儿病情稳定后,未给予降脂药物,启用肠内营养,喂养实施例3肠内营养粉剂,耐受性良好,无腹胀、腹泻等不良反应。随访第7天,甘油三酯18.71mmol/L,高密度脂蛋白胆固醇2.13mmol/L,低密度脂蛋白胆固醇0.71mmol/L。2周后改用实施例2肠内营养粉剂,2个月后随访甘油三酯水平控制在11.0mmol/L左右,生长发育状况良好,建议长期服用实施例2肠内营养粉剂。
乳清蛋白在众多种类的蛋白中利用率最高。乳清蛋白的生物价104、蛋白质功效比3.2、净利用率92,是蛋白质营养补充的极佳来源。同时乳清蛋白中免疫球蛋白和乳铁蛋白具有免疫活性和抗氧化特性,可以提高儿童机体免疫力。
ω-3脂肪酸是人体自身无法合成的、必须从食物中摄取的必需脂肪酸,成份主要有三种:α-亚麻酸、二十碳五烯酸(EPA)、二十二碳六烯酸(DHA),其中EPA具有降低血胆固醇和甘油三酯的作用。研究发现,早期肠内营养(EEN)联合ω-3多不饱和脂肪酸早期可控制急性胰腺炎炎症反应和平衡T细胞的作用,降低细胞因子水平及调节细胞免疫功能。
ω-6脂肪酸是多元不饱和脂肪酸,属于必需脂肪酸,在人体内无法自行合成,必须从食物中获取。ω-6脂肪酸在人体内会转化成花生四烯酸,能杀死肿瘤细胞,而且对正常细胞无毒副作用,具有扩张血管的作用,可刺激棕色脂肪组织,起到防止肥胖的作用。药典上采用亚油酸乙酯作为预防和治疗高血压、动脉粥样硬化症、冠心病的药物。但是一些医学研究表明,过量的ω-6脂肪酸会干扰ω-3脂肪酸对健康的益处,因为它们会争夺相同的限速酶。长期超量的ω-6脂肪酸会引起慢性心脏病发作、血栓性中风、心律不齐、关节炎、骨质疏松症、炎症、情绪障碍、肥胖与癌症等疾病。过高的ω-6脂肪酸:ω-3脂肪酸比值,转移了组织对许多疾病发病机制的生理状态,比如血栓,炎症等,可能会增加一些疾病的概率。因此,目前认为ω-6脂肪酸:ω-3脂肪酸的最佳比例为4:1或更低。
中链脂肪酸(medium chain fatty acid,MCFA)一般是含有6~12个碳原子组成碳链的脂肪酸,是自然界中含量比较少的脂肪酸,主要来源于母乳、牛奶及其制品、棕榈仁油和椰子油等,代表性的MCFA有辛酸和癸酸。日常摄取食物中的MCFA常以中链甘油三酯(MCT)的形式存在。典型的MCT是指饱和辛酸甘油三酯或饱和癸酸甘油三酯或饱和辛酸-癸酸混合的甘油三酯。中链脂肪酸除少量在周围血液中短期存在外,大部分与白蛋白结合,通过门静脉系统较快地到达肝脏。在肝脏中,中链脂肪酸能迅速通过线粒体双层膜,在辛酰CoA作用下迅速被酰化,而几乎不被合成脂肪。
中链甘油三酯(MCT)仅由饱和脂肪酸构成,凝固点低,室温下为液体,粘度小。与大豆油比较,完全是无臭、无色的透明液体。与普通的油脂和氢化油脂相比,中链甘油三酯中不饱和脂肪酸的含量极低,氧化稳定性好。故MCT在高温和低温下特别稳定。中链甘油三酯具有良好的溶解性以及能被快速吸收,其分子量小,水解速度比长链甘油三酯(LCT)快,且不需肉毒碱转运,直接通过门静脉到肝脏分解产生能量,其消化吸收速度是LCT的4倍,代谢速度是LCT的10倍。同时,MCT迅速代谢氧化会形成大量酮体,其膳食中应同时补充富含碳水化合物的食物,避免酮血症。
麦芽糊精是DE值5-20的淀粉水解产物,是一种价格低廉、口感滑腻、没有任何味道的营养性多糖。不仅为机体提供能量,还具有低甜度,无异味,易消化,溶解性好等特性,极易被人体吸收,特别适宜作病人和婴幼儿童食品的基础原料。
牛磺酸(Taurine,Tau)是动物体内一种结构简单的含硫氨基酸,牛磺酸是人体的条件必需氨基酸,对胎儿、婴儿神经系统的发育有重要作用。诸多研究发现,牛磺酸是调节机体正常生理活动的活性物质,具有消炎、维持机体渗透压平衡、维持正常视觉功能、调节细胞钙平衡、调节神经传导、调节脂类消化与吸收、提高机体免疫能力、增强细胞膜抗氧化能力等广泛的生物学功能。肝脏中牛磺酸的作用是与胆汁酸结合形成牛黄胆酸,牛磺胆酸对消化道中脂类的吸收是必需的。牛磺胆酸能增加脂质和胆固醇的溶解性,解除胆汁阻塞,降低某些游离胆汁酸的细胞毒性,抑制胆固醇结石的形成,增加胆汁流量等。
左旋肉碱酒石酸盐是左旋肉碱的稳定形态,左旋肉碱是一种天然存在的类维生素的营养素,与动物体内的脂肪酸代谢密切相关,红色肉类是左旋肉碱的主要来源。左旋肉碱可以作为载体以脂酰肉碱的形式将长链脂肪酸从线粒体膜外转运到膜内,在线粒体内进行β-氧化。左旋肉碱不仅在脂肪代谢过程中起重要作用,而且在促进婴幼儿发育的某些生理过程,如生酮作用、氮代谢等方面均具有一定的功能。成人能够自己合成维持正常代谢所需的左旋肉碱浓度,但婴幼儿体内合成左旋肉碱能力极低,主要通过母乳及配方食品补充。对于上述脂代谢异常的患儿,动物性食物摄入受限,会影响体内左旋肉碱含量,进而影响脂代谢及供能过程。
渗透压与胃肠道耐受性密切相关,较高渗透压的制剂容易引起腹胀、腹泻及其他肠道反应,标准整蛋白的肠内配方通常是等渗的,约300mmol/L H2O。通常整蛋白为氮源的肠内营养制剂其渗透压较低,而要素型肠内营养制剂的渗透压则较高。
Claims (5)
1.一种适用于1~10岁脂代谢异常患儿的肠内营养粉剂,其特征在于,由以下重量份的各组分组成,蛋白质10~25份,脂肪15.5份,碳水化合物54~69份,维生素0.05~0.15份,矿物质0.5~2.5份,左旋肉碱酒石酸盐0.01~0.03份,牛磺酸0.01~0.03份,水分2.0~4.0份。
2.根据权利要求1所述的肠内营养粉剂,优选重量份配比为蛋白质14份,脂肪15.5份,碳水化合物65份,左旋肉碱酒石酸盐0.02份,牛磺酸0.02份,水分3.0份,维生素0.05~0.15份,矿物质0.5~2.5份。
3.根据权利要求1、2任意一项所述的肠内营养粉剂,其特征在于,所述碳水化合物为麦芽糊精;所述的蛋白质为乳清蛋白;所述的脂肪由ω-3、ω-6和中链甘油三酯(MCT)组成,且ω-3:ω-6:MCT的重量百分比为2.5%~3.2%:10%~13%:84%~87%。
4.根据权利要求1至3任意一项所述的肠内营养粉剂,其特征在于,所述维生素重量配比如下:维生素A 0.0004-0.001份,维生素B10.0003-0.003份,维生素B2 0.0003-0.003份,烟酸0.0016-0.005,泛酸0.0016-0.005份,维生素B6 0.0003-0.003份,生物素0.000001-0.000015份,叶酸0.00003-0.00014份,维生素B12 0.0000009-0.000002份,维生素C 0.04-0.2份,维生素D3 0.000006-0.000017份,维生素E 0.003-0.07份,维生素K1 0.00002-0.00003份;
所述矿物质重量配比如下:钾0.4-0.6份,钙0.4-0.6份,钠0.15-0.46份,磷0.2-0.8份,锰0.000006-0.0001份,镁0.035~0.15份,铁0.0058~0.01份,锌0.0022~0.008份,铜0.00016-0.0008份,碘0.00003-0.00007份,钼0.00003-0.00013份,硒0.00001-0.00006份,铬0.00001-0.000025。
5.一种制备权利要求1至4任意一项肠内营养粉剂的方法,其特征在于,包括以下步骤:
(1)按照配比,称取各组分,将各组分形成的混合物置入搅拌机中,加入50~60℃纯净水,通入惰性气体氮气,在500-800rpm的转速下进行搅拌10~15min直至充分溶解混匀得到第一混合浆体;所述步骤(1)中的混合物与纯净水的重量比为1:3~5;
(3)将步骤(1)中所得第一混合浆体转入高压均质机中均质,均质温度40~50℃,均质压力为15~20kPa,均质两次后过100~120目筛,得到第二混合浆体进行贮存备用,贮存备用时保存温度在10℃以下,转速80~100rpm,保存时间不超过10h;
(4)将步骤(3)所得的第二混合浆体在85~95℃高温下短时杀菌,杀菌时间15~20s,得到第三混合浆体;
(5)将步骤(4)中得到的无菌的第三混合浆体进行喷雾干燥,喷雾干燥进风为干燥的无氧气体,风速为7.00~7.30m/s,进风温度160-185℃,排风温度75-85℃,喷雾干燥至水分在8%~12%;
(6)将步骤(5)中得到的粉末放入流化床,流化床分为三个区段,分别是从下方吹入清洁的30~40℃温空气、50~65℃的热空气和0~5℃的冷空气,潮湿的粉末首先富聚成稳定的团粒,经温空气和热空气干燥至水分含量在2%~4%,后吹入冷空气将成品冷却,吹出细分后过80-100目筛;
(7)将所得的均匀富聚性稳定的团粒真空或充氮独立罐装,制得所需肠内营养粉剂。
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