CN111194912A - 一种稳定的医用液态肠内营养组合物及其制备方法 - Google Patents
一种稳定的医用液态肠内营养组合物及其制备方法 Download PDFInfo
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- CN111194912A CN111194912A CN201910616685.5A CN201910616685A CN111194912A CN 111194912 A CN111194912 A CN 111194912A CN 201910616685 A CN201910616685 A CN 201910616685A CN 111194912 A CN111194912 A CN 111194912A
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- vitamin
- feed liquid
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- oil
- protein
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- A—HUMAN NECESSITIES
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Abstract
本发明属于特殊医学用途配方食品技术领域,具体涉及一种稳定的医用液态肠内营养组合物及其制备方法。每1L该肠内营养组合物配方:蛋白质36.25~83.05g,脂肪23.7~56.2g、碳水化合物103.5~245.7g、膳食纤维0~41.5g、维生素预混料0.36~0.87g、矿物质预混料一1.86~4.58g、矿物质预混料二14.24~31.49g、乳化剂0.72~4.19g、稳定剂0.68~2.75g;溶剂为水。本发明通过优化制备工艺流程,减少了维生素的损失,使其具有良好的稳定性。本发明工艺简单,易操作、易连续化生产,产业化前景广阔。
Description
技术领域
本发明属于特殊医学用途配方食品技术领域,具体涉及一种稳定的医用液态肠内营养组合物及其制备方法。
背景技术
肠内营养制剂配合药物或手术治疗,对于疾病的转归、患者营养状况的改善具有积极的促进作用。据统计,我国需要营养治疗的患者占住院人数60%~70%。目前,随着我国社会老龄化的“加速”,以及40岁以上人群中慢性疾病患者人数呈现逐年快速增加的趋势,我国临床营养领域正面临着巨大的市场需求。
在临床应用上,与粉剂类产品相比,液态肠内营养制剂可直接食用或管饲,无需冲调,使用更加方便。目前,市场上已有很多液态肠内营养制剂,其中一些产品是为特殊人群研制,例如中国专利公开号为CN106307504A、CN106616959A、CN105029410A等;还有一些产品中的添加成分不符合《GB29922食品安全国家标准特殊医学用途配方食品通则》中对于特殊医学用途全营养配方食品的要求,例如某些配方中添加了苦瓜粉;还有一些产品中仅添加了部分维生素及矿物质,营养素不全面。目前,需对营养素进行全面补充且对特定营养素没有特别要求的人群占绝大多数。因此,根据GB29922的要求,参考2013版中国居民膳食营养素参考摄入量(DRIs),研制营养全面均衡的特殊医学用途全营养配方食品具有重要的社会意义。
然而液态肠内营养制剂作为一种极为复杂的食品体系,各营养素之间极易发生相互作用,导致生产过程中维生素损失较多,另外还影响产品的稳定性,容易出现蛋白质沉淀、脂肪上浮等分层现象,严重限制了其在临床上的应用。
发明内容
为解决液态肠内营养制剂中维生素易损失,产品稳定性不佳的技术问题,本发明提供一种医用液态肠内营养组合物及其制备方法。
本发明通过大量实验研究发现,部分矿物质营养素是影响维生素损失的关键因素,通过合理控制加料顺序以及物料流速,可以显著降低维生素的损失;并且意外地发现还显著地提升了产品的稳定性,在长达12个月的保质期内未出现明显蛋白质沉淀、脂肪上浮等分层现象。
具体而言,本发明提供一种医用液态肠内营养组合物的制备方法,该医用液态肠内营养组合物的原料包括蛋白质、脂肪、乳化剂、碳水化合物、膳食纤维、维生素、矿物质和稳定剂;该制备方法包括:
1)脂肪乳制备
①按配比称取蛋白质、水溶性乳化剂,加入至40~60℃纯水中,搅拌至完全溶解,得蛋白相;
②按配比称取脂肪、油溶性乳化剂,于40~80℃搅拌至混匀,得油相;
③将步骤②所得油相加至步骤①所得蛋白相中,剪切搅拌;将所得料液均质,得脂肪乳;
2)按配比称取碳水化合物、膳食纤维、稳定剂,加入至40~60℃纯水中,搅拌至完全溶解,得料液A;
3)将所述料液A加入至上述脂肪乳中,混合均匀,得料液B;
4)按配比称取矿物质预混料一,加入至40~60℃纯水中,搅拌完全溶解后,加至所述料液B中,混合均匀,得料液C;
其中,矿物质预混料一中含铜、镁、铁和锌元素,各元素用量可根据所需进行合理调整;
5)按配比称取矿物质预混料二,加入至40~60℃纯水中,搅拌完全溶解后,以不高于23L/min的流速加入至所述料液C中,混合均匀,得料液D;
其中,矿物质预混料二中含钠、钾、锰、钙、磷、氯和硒元素,各元素用量可根据所需进行合理调整;
6)按配比称取维生素预混料,加入至25~40℃纯水中,搅拌完全溶解后,以不高于12L/min的流速加入至所述料液D中,混合均匀,得料液E;
7)将所述料液E冷却至30℃以下,得料液F;
8)将所述料液F均质,过滤;或者进一步还包括将过滤后所得料液灭菌、灌装的步骤。
上述制备方法中,
步骤1)所述均质压力优选为15~35MPa,温度为50~70℃;更优选均质1~2次。
步骤5)所述流速具体可为12L/min、15L/min、20L/min、21L/min或23L/min,优选为12-21L/min。研究发现,本步骤的加料流速对于终产品即所述医用液态肠内营养组合物的粒径及物理稳定性具有显著影响。若加料流速过高,则粒径变大,Slope变大,物理稳定性降低;若加料流速过低,则会降低生产效率。综合粒径及物理稳定性两方面考虑,以加料流速不高于23L/min为宜,尤以流速12-21L/min为佳。
步骤6)所述流速具体可为7L/min、8.5L/min、10L/min或12L/min,优选为7-8.5L/min。研究发现,本步骤的加料流速对于终产品即所述医用液态肠内营养组合物内维生素含量具有显著影响。若加料流速过高,则维生素易损失造成含量降低;若加料流速过低,则会降低生产效率。从维生素含量的角度考虑,以加料流速不高于12L/min为宜,尤以流速7-8.5L/min为佳。
优选地,步骤8)所述均质压力为15~35MPa,温度为50~70℃;更优选均质1~2次。
进一步地,步骤8)采用200目双联过滤器进行过滤。
优选地,所述灭菌条件:125~150℃灭菌5~15s;灭菌后迅速冷却至20~30℃,灌装(例如灌装于玻璃瓶或利乐砖中),充氮,密封。
进一步地,本发明所述蛋白质选自浓缩牛奶蛋白、大豆分离蛋白、酪蛋白、水解乳清蛋白、大豆肽、浓缩乳清蛋白、分离乳清蛋白、酪蛋白酸钠、酪蛋白酸钙、豌豆蛋白、胶原蛋白肽等中的一种或几种。
进一步地,本发明所述脂肪选自低芥酸菜籽油、玉米油、椰子油、高油酸葵花籽油、中链甘油三酯、大豆油、花生油、亚麻籽油、紫苏籽油、棕榈油、DHA藻油、鱼油等中的一种或几种。
进一步地,本发明所述碳水化合物选自葡萄糖浆、葡萄糖浆干粉、麦芽糊精、蔗糖(白砂糖)、葡萄糖、果糖等中的一种或几种。
进一步地,本发明所述膳食纤维选自菊粉、聚葡萄糖、低聚半乳糖、低聚果糖、多聚果糖、棉籽糖、水苏糖、抗性糊精、抗性淀粉、大豆多糖等中的一种或几种。
进一步地,本发明所述维生素预混料的组成和用量可根据本发明所述医用液态肠内营养组合物终产品的营养成分含量进行调整。
进一步地,本发明所述维生素预混料中含有以下任一种或几种组分:维生素A、维生素D、维生素E、维生素K1、维生素B1、维生素B2、维生素B6、维生素B12、烟酰胺、叶酸、泛酸、维生素C、生物素和碘。
较佳地,本发明所述维生素预混料中各组分及其含量如下表所示:
进一步地,本发明所述维生素A来源于维生素A棕榈酸酯、维生素A醋酸酯、β-胡萝卜素、全反式视黄醇中的一种或几种;维生素D来源于胆钙化醇(维生素D3)、麦角钙化醇(维生素D2);维生素E来源于d-α-生育酚、dl-α-生育酚、d-α-醋酸生育酚、dl-α-醋酸生育酚、混合生育酚浓缩物、d-α-琥珀酸生育酚、dl-α-琥珀酸生育酚中的一种或两种;维生素B1来源于盐酸硫胺素、硝酸硫胺素中的一种或两种;维生素B2来源于核黄素、核黄素-5′-磷酸钠中的一种或两种;维生素B6来源于盐酸吡哆醇、5′-磷酸吡哆醇中的一种或两种;维生素B12来源于氰钴胺、烟酸氰钴胺、羟钴胺中的一种或两种;烟酰胺来源于烟酸、烟酰胺中的一种或两种;叶酸来源于叶酸;泛酸来源于D-泛酸钙、D-泛酸钠中的一种或两种;维生素C来源于抗坏血酸、L-抗坏血酸钠、L-抗坏血酸钙、L-抗坏血酸钾、抗坏血酸棕榈酸酯中的一种或两种;生物素来源于D-生物素;碘来源于碘化钾、碘酸钾、碘化钠中的一种或两种。
进一步地,本发明所述矿物质预混料一的组成和用量可根据本发明所述医用液态肠内营养组合物终产品的矿物质含量进行调整。较佳地,所述矿物质预混料一中各组分及其含量如下表所示:
营养成分 | 含量 |
铜,μg/g | 144.06~267.54 |
镁,mg/g | 56.595~105.105 |
铁,mg/g | 3.087~5.733 |
锌,mg/g | 2.058~3.822 |
进一步地,本发明所述铜来源于硫酸铜、葡萄糖酸铜、柠檬酸铜、碳酸铜中的一种或两种;镁来源于硫酸镁、氧化镁、碳酸镁、氯化镁、磷酸氢镁、葡萄糖酸镁中的一种或几种;铁来源于硫酸亚铁、葡萄糖酸亚铁、焦磷酸铁、柠檬酸铁铵、富马酸亚铁、柠檬酸铁中的一种或几种;锌来源于硫酸锌、葡萄糖酸锌、氧化锌、乳酸锌、柠檬酸锌、氯化锌、乙酸锌中的一种或两种。
进一步地,所述矿物质预混料二的组成和用量可根据本发明所述医用液态肠内营养组合物终产品的矿物质含量进行调整。较佳地,所述矿物质预混料二中各组分及其含量如下表所示:
营养成分 | 含量 |
钠,mg/g | 26.25~63.00 |
钾,mg/g | 35.70~85.68 |
锰,μg/g | 88.2~163.8 |
钙,mg/g | 6.72~43.68 |
磷,mg/g | 19.81~36.80 |
氯,mg/g | 22.75~42.25 |
硒,μg/g | 1.47~2.73 |
进一步地,所述钠来源于碳酸氢钠、磷酸二氢钠、柠檬酸钠、氯化钠、磷酸氢二钠中的一种或几种;钾来源于葡萄糖酸钾、氯化钾、柠檬酸钾、磷酸二氢钾、磷酸氢二钾中的一种或几种;锰来源于硫酸锰、氯化锰、碳酸锰、柠檬酸锰、葡萄糖酸锰中的一种或两种;钙来源于碳酸钙、葡萄糖酸钙、柠檬酸钙、L-乳酸钙、氯化钙、磷酸钙、磷酸氢钙、氧化钙、硫酸钙中的一种或几种;所述磷来源于磷酸二氢钠、磷酸氢二钠、磷酸二氢钾、磷酸氢二钾、磷酸钙、磷酸氢钙中的一种或几种;所述氯来源于氯化钠、氯化钾、氯化锰、氯化钙中的一种或几种;硒来源于硒酸钠、亚硒酸钠中的一种或几种。
进一步地,本发明所述水溶性乳化剂选自聚甘油脂肪酸酯、蔗糖脂肪酸酯、双乙酰酒石酸单双甘油酯等中的一种或几种;所述油溶性乳化剂选自大豆磷脂、单双甘油脂肪酸酯、琥珀酸单甘油酯等中的一种或几种。
进一步地,本发明所述稳定剂选自卡拉胶、微晶纤维素、羧甲基纤维素钠、黄原胶、结冷胶、果胶、羟丙基淀粉、刺槐豆胶等中的一种或几种。
本发明所用各原料用量符合法规例如GB29922要求。
在本发明具体实施方式中,所述医用液态肠内营养组合物,每1L该肠内营养组合物配方:蛋白质36.25~83.05g,脂肪23.7~56.2g、碳水化合物(以干基计)103.5~245.7g、膳食纤维0~41.5g、维生素预混料0.36~0.87g、矿物质预混料一1.86~4.58g、矿物质预混料二14.24~31.49g、乳化剂0.72~4.19g、稳定剂0.68~2.75g;溶剂(或载体)为水(余量)。
此外,应理解,本文中“包括”、“包含”、“含有”等术语的含义中也包括了“由……组成”、“由……构成”“由……制成”等。
本发明还包括上述方法制备的医用液态肠内营养组合物。
在本发明具体实施方式中,所述医用液态肠内营养组合物,每1L该肠内营养组合物含有如下组分:
成分 | 含量 |
蛋白质,g | 27.5~62.9 |
脂肪,g | 23.7~54.2 |
亚油酸,g | ≥2.22 |
α-亚麻酸,g | ≥0.556 |
碳水化合物,g | 93.1~212.9 |
维生素A,μg RE | 469~2250 |
维生素D,μg | 8.89~31.4 |
维生素E,mgα-TE | 8.74~466 |
维生素K1,μg | ≥46.9 |
维生素B1,mg | ≥1.07 |
维生素B2,mg | ≥1.05 |
维生素B6,mg | 1.03~39.97 |
维生素B12,μg | ≥1.4 |
烟酸(烟酰胺),mg | 10~199.87 |
叶酸,μg | 234~666 |
泛酸,mg | ≥3.56 |
维生素C,mg | 106.7~133.2 |
生物素,μg | ≥21.3 |
钠,mg | ≥889 |
钾,mg | ≥1209 |
铜,μg | 497~5000 |
镁,mg | ≥195 |
铁,mg | 10.7~23 |
锌,mg | 7.11~22 |
锰,μg | 2133~6110 |
钙,mg | 569~1332 |
磷,mg | 427~803 |
碘,μg | 71.1~133.9 |
氯,mg | 1066~2180 |
硒,μg | 35.6~222 |
膳食纤维,g | ≤27 |
进一步地,所述医用肠内营养组合物的pH为6.0~7.2;优选为6.5~6.9。其目的是一方面降低美拉德反应的速率,避免产品在保质期内出现严重褐变;另一方面可降低部分维生素的损失率,从而提高产品的化学稳定性。
进一步地,所述医用肠内营养组合物的粒径不高于650nm;优选为230~420nm。其目的是避免乳滴因粒径过大而聚结,从而使产品保持稳定。
进一步地,所述医用肠内营养组合物的ζ-电位不低于-20mV;优选为-25~-35mV。其目的是避免乳滴因ζ-电位较小而相互凝结或凝聚,从而使产品保持稳定。
本发明还包括上述医用肠内营养组合物在制备肠内营养制剂方面的应用。
有益效果
本发明依据GB29922中对全营养配方食品各营养素种类及含量的要求,并参考2013版中国DRIs,对医用液态肠内营养组合物的配方进行合理设计;通过优化脂肪乳制备流程,控制矿物质预混料及维生素预混料的投料,较大地提高了脂肪的乳化效果,避免了矿物质对乳液体系稳定性的影响,并降低了工艺过程中维生素的损失,有效地提高了产品稳定性。本发明工艺简单,易操作、易连续化生产,产业化前景广阔。
附图说明
图1表示实验例4矿物质预混料一的添加流速对肠内营养组合物粒径及物理稳定性的影响。
具体实施方式
以下实施例用于说明本发明,但不用来限制本发明的范围。实施例中未注明具体技术或条件者,按照本领域内的文献所描述的技术或条件,或者按照产品说明书进行。所用试剂或仪器未注明生产厂商者,均为可通过正规渠道商购买得到的常规产品。
以下各实施例中,所用维生素预混料的组成及含量为:
组分 | 含量(mg/g) |
棕榈酸视黄酯 | 11.2985 |
胆钙化醇 | 0.0331 |
dl-α-醋酸生育酚 | 37.465 |
植物甲萘醌 | 0.1749 |
盐酸硫胺素 | 2.4722 |
核黄素 | 2.3965 |
盐酸吡哆醇 | 2.3724 |
氰钴胺 | 0.0061 |
烟酰胺 | 23.4847 |
叶酸 | 0.5311 |
D-泛酸钙 | 8.3415 |
L-抗坏血酸 | 486.8182 |
D-生物素 | 0.0795 |
碘酸钾 | 0.2573 |
麦芽糊精 | 424.269 |
以下各实施例中,所用矿物质预混料一的组成及含量为:
组分 | 含量(mg/g) |
硫酸铜 | 0.7235 |
硫酸镁 | 535.0368 |
硫酸亚铁 | 12.5267 |
硫酸锌 | 7.3066 |
麦芽糊精 | 444.4064 |
以下各实施例中,矿物质预混料二的组成及含量为:
组分 | 含量(mg/g) |
氯化钠 | 88.1315 |
磷酸二氢钠 | 125.4912 |
氯化钾 | 76.5903 |
柠檬酸钾 | 351.0165 |
硫酸锰 | 0.4995 |
碳酸钙 | 26.5096 |
亚硒酸钠 | 0.0053 |
麦芽糊精 | 261.064 |
实施例1
一种稳定的医用液态肠内营养组合物,每1L该肠内营养组合物的配方:浓缩牛奶蛋白28.3g、大豆分离蛋白8.4g、低芥酸菜籽油21.5g、玉米油7.6g、椰子油4.2g、葡萄糖浆185g、菊粉2g、聚葡萄糖3g、维生素预混料0.66g、矿物质预混料一3.43g、矿物质预混料二16.72g、酪蛋白酸钠7.2g、聚甘油脂肪酸酯0.38g、单双甘油脂肪酸酯0.95g、琥珀酸单甘油酯0.5g、卡拉胶0.45g、微晶纤维素0.57g;余量为水。
本实施例还提供该医用液态肠内营养组合物的制备方法,包括如下步骤:
1)脂肪乳制备
①按配比称取浓缩牛奶蛋白、大豆分离蛋白、酪蛋白酸钠、聚甘油脂肪酸酯,加入至含有50℃纯水的真空混料罐中,搅拌至完全溶解,得水相。
②按配比称取低芥酸菜籽油、玉米油、椰子油、单双甘油脂肪酸酯、琥珀酸单甘油酯,加入至60℃的化油罐中,搅拌至完全混合,得油相。
③将步骤②所得油相加至步骤①所得水相中进行剪切搅拌,所得料液进行均质,均质压力为30MPa,温度为65℃,均质1次,得脂肪乳。
2)按配比称取葡萄糖浆、菊粉、聚葡萄糖、卡拉胶、微晶纤维素,加入至含有60℃纯水的混料罐中,搅拌至完全溶解,得料液A。
3)将所述料液A加至上述脂肪乳中,混合均匀,得料液B。
4)按配比称取矿物质预混料一,加至含有50℃纯水的混料罐中,搅拌完全溶解后,加至料液B中,混合均匀,得料液C。
5)按配比称取矿物质预混料二,加至50℃纯水的混料罐中,搅拌完全溶解后,以12L/min的流速加至料液C中,混合均匀,得料液D。
6)按配比称取维生素预混料,加至含有30℃纯水的混料罐中,搅拌完全溶解后,以7L/min的流速加至料液D中,混合均匀,得料液E。
7)将料液E冷却至30℃以下,定容,得料液F。
8)将料液F进行均质,均质压力为25MPa,温度为60℃,均质2次。
9)所得料液通过200目双联过滤器进行过滤。
10)所得料液于137℃灭菌10s,迅速冷却至25℃,灌装于利乐砖中,充氮,密封。
实施例2
一种稳定的医用液态肠内营养组合物,每1L该肠内营养组合物的配方:酪蛋白26.8g、水解乳清蛋白6.9g、大豆肽5.5g、低芥酸菜籽油18g、高油酸葵花籽油4.5g、玉米油4.3g、椰子油6.8g、麦芽糊精137g、蔗糖6g、聚葡萄糖4g、低聚半乳糖3.2g、维生素预混料0.66g、矿物质预混料一3.43g、矿物质预混料二16.72g、蔗糖脂肪酸酯0.13g、单双甘油脂肪酸酯0.75g、大豆磷脂0.22g、结冷胶0.28g、卡拉胶0.35g;余量为水。
本实施例医用液态肠内营养组合物的制备方法,包括如下步骤:
1)脂肪乳制备
①按配比称取酪蛋白、水解乳清蛋白、大豆肽、蔗糖脂肪酸酯,加入至含50℃纯水的真空混料罐中,搅拌至完全溶解,得水相。
②按配比称取低芥酸菜籽油、高油酸葵花籽油、玉米油、椰子油、单双甘油脂肪酸酯、大豆磷脂,加入至60℃的化油罐中,搅拌至完全混合,得油相。
③将步骤②所得油相加至步骤①所得水相中进行剪切搅拌,所得料液进行均质,均质压力为30MPa,温度为60℃,均质1次,得脂肪乳。
2)按配比称取麦芽糊精、蔗糖、聚葡萄糖、低聚半乳糖、结冷胶、卡拉胶,加入至含有60℃纯水的混料罐中,搅拌至完全溶解,得料液A。
3)将料液A加至脂肪乳中,混合均匀,得料液B。
4)按配比称取矿物质预混料一,加至含有60℃纯水的混料罐中,搅拌完全溶解后,加至料液B中,混合均匀,得料液C。
5)按配比称取矿物质预混料二,加至60℃纯水的混料罐中,搅拌完全溶解后,以21L/min的流速加至料液C中,混合均匀,得料液D。
6)按配比称取维生素预混料,加至含有30℃纯水的混料罐中,搅拌完全溶解后,以8.5L/min的流速加至料液D中,混合均匀,得料液E。
7)将料液E冷却至30℃以下,定容,得料液F。
8)将料液F进行均质,均质压力为25MPa,温度为60℃,均质2次。
9)所得料液通过200目双联过滤器进行过滤。
10)所得料液于137℃灭菌10s,迅速冷却至25℃,灌装于玻璃瓶中,充氮,密封。
对比例1
一种医用液态肠内营养组合物,配方与实施例1相同,与实施例1的区别仅在于制备方法的不同,该肠内营养组合物的制备方法包括如下步骤:
1)脂肪乳制备
①按配比称取浓缩牛奶蛋白、大豆分离蛋白、酪蛋白酸钠、聚甘油脂肪酸酯、葡萄糖浆、菊粉、聚葡萄糖、卡拉胶、微晶纤维素,加入至含有50℃纯水的真空混料罐中,搅拌至完全溶解,得水相。
②按配比称取低芥酸菜籽油、玉米油、椰子油、单双甘油脂肪酸酯、琥珀酸单甘油酯,加入至60℃的化油罐中,搅拌至完全混合,得油相。
③将步骤②所得油相加至步骤①所得水相中进行剪切搅拌,所得料液进行均质,均质压力为30MPa,温度为65℃,均质1次,得脂肪乳。
2)按配比称取矿物质预混料一,加至含有50℃纯水的混料罐中,搅拌完全溶解后,加至脂肪乳中,混合均匀,得料液A。
3)按配比称取矿物质预混料二,加至50℃纯水的混料罐中,搅拌完全溶解后,以12L/min的流速加至料液A中,混合均匀,得料液B。
4)按配比称取维生素预混料,加至含有30℃纯水的混料罐中,搅拌完全溶解后,以7L/min的流速加至料液B中,混合均匀,得料液C。
5)将料液C冷却至30℃以下,定容,得料液D。
6)将料液D进行均质,均质压力为25MPa,温度为60℃,均质2次。
7)所得料液通过200目双联过滤器进行过滤。
8)所得料液于137℃灭菌10s,迅速冷却至25℃,灌装于利乐砖中,充氮,密封。
对比例2
一种医用液态肠内营养组合物,配方与实施例2相同,与实施例2的区别仅在于制备方法的不同,该肠内营养组合物的制备方法包括如下步骤:
1)脂肪乳制备
①按配比称取酪蛋白、水解乳清蛋白、大豆肽、蔗糖脂肪酸酯,加入至含50℃纯水的真空混料罐中,搅拌至完全溶解,得水相。
②按配比称取低芥酸菜籽油、高油酸葵花籽油、玉米油、椰子油、单双甘油脂肪酸酯、大豆磷脂,加入至60℃的化油罐中,搅拌至完全混合,得油相。
③将步骤②所得油相加至步骤①所得水相中进行剪切搅拌,所得料液进行均质,均质压力为30MPa,温度为60℃,均质1次,得脂肪乳。
2)按配比称取麦芽糊精、蔗糖、聚葡萄糖、低聚半乳糖、结冷胶、卡拉胶,加入至含有60℃纯水的混料罐中,搅拌至完全溶解,得料液A。
3)将料液A加至脂肪乳中,混合均匀,得料液B。
4)按配比称取矿物质预混料一、矿物质预混料二,加至含有60℃纯水的混料罐中,搅拌完全溶解后,以21L/min的流速加至料液B中,混合均匀,得料液C。
6)按配比称取维生素预混料,加至含有30℃纯水的混料罐中,搅拌完全溶解后,以8.5L/min的流速加至料液D中,混合均匀,得料液E。
7)将料液E冷却至30℃以下,定容,得料液F。
8)将料液F进行均质,均质压力为25MPa,温度为60℃,均质2次。
9)所得料液通过200目双联过滤器进行过滤。
10)所得料液于137℃灭菌10s,迅速冷却至25℃,灌装于玻璃瓶中,充氮,密封。
以下实验例所用检测方法:
(1)粒径:采用激光粒度分析仪进行测定。
(2)ζ-电位:采用Zeta电位分析仪进行测定。
(3)物理稳定性:采用LUMiSizer快速稳定性分析仪进行测定,以Slope值进行表征,Slope值越小代表产品物理稳定性越好。
实验例1
按照《GB29922食品安全国家标准特殊医学用途配方食品通则》中规定的检测方法,对实施例1-2及对比例1-2制备的肠内营养组合物中各营养成分的含量进行检测,并与GB29922中对营养成分含量的要求进行对比,对比结果见下表1:
表1肠内营养组合物中各营养成分含量
实验例2
对实施例1-2及对比例1-2制备的肠内营养组合物的基本理化指标进行检测,结果见下表2:
表2肠内营养组合物的理化指标检测结果
实验例3
对实施例1-2及对比例1-2所述医用肠内营养组合物的粒径、物理稳定性进行检测,结果见下表3:
表3实施例与对比例的粒径及Slope值
检测结果 | 粒径/nm | Slope值/%/s |
实施例1 | 326±4 | 0.0023±0.0002 |
对比例1 | 782±6<sup>**</sup> | 0.0095±0.0002<sup>**</sup> |
实施例2 | 378±3 | 0.0031±0.0001 |
对比例2 | 713±5<sup>**</sup> | 0.0082±0.0003<sup>**</sup> |
注:*表示与实施例相比,P<0.05;**表示与实施例相比,P<0.01。
表3实验结果表明,对比例1-2的粒径均显著高于实施例1-2,其Slope值也显著低于实施例1-2,进一步说明肠内营养组合物的制备过程中,脂肪乳制备方法和矿物质预混料的投料顺序对其粒径及物理稳定性具有重要影响。
实验例4
按照实施例1肠内营养组合物的配方,并参照实施例1肠内营养组合物的制备方法,区别仅在于调整步骤5)流速分别为17L/min、23L/min、28L/min、33L/min,分别检测所制得的肠内营养组合物的部分维生素含量、粒径及物理稳定性,肠内营养组合物中部分维生素的含量结果见表4,肠内营养组合物粒径及物理稳定性的结果见图1。
表4肠内营养组合物中部分维生素含量的比较
注:*表示与实施例1相比,P<0.05;**表示与实施例1相比,P<0.01。
表4实验结果表明,与实施例1相比,组合物1-2中以上维生素含量变化较小,而组合物3-4中以上维生素含量均显著降低,进一步说明肠内营养组合物的制备过程中,控制矿物质预混料二添加至料液C的流速,可大大降低部分维生素的损失情况。
实验例5
按照实施例1肠内营养组合物的配方,并参照实施例1肠内营养组合物的制备方法,区别仅在于调整步骤6)流速分别为8L/min、12L/min、16L/min、20L/min,分别检测所制得的肠内营养组合物中维生素的含量并进行对比,结果见下表5:
表5肠内营养组合物中维生素含量的比较
注:*表示与实施例1相比,P<0.05;**表示与实施例1相比,P<0.01。
表5实验结果表明,与实施例1相比,组合物1-2的维生素含量变化较小,而组合物3-4的部分维生素的含量均明显降低,其中包括维生素A、维生素E、维生素B1、维生素B2、叶酸、维生素C。进一步说明肠内营养组合物的制备过程中,控制维生素预混料添加至料液D的流速,可大大降低维生素的损失情况。
实验例6
对实施例1-2及对比例1-2制得的肠内营养组合物进行贮藏试验,将样品置于25℃恒温箱中保存12个月,每隔3个月测定样品粒径及Slope值,结果见下表6:
表6肠内营养组合物贮藏试验结果
注:*表示与0月相比,P<0.05;**表示与0月相比,P<0.01。
表6实验结果表明,与对比例1-2相比,实施例1-2所制得的肠内营养组合物经常温储藏12个月后,粒径及Slope值均未显著变化,且未明显出现脂肪上浮等分层现象,进一步说明肠内营养组合物具有良好的物理稳定性。
虽然,上文中已经用一般性说明及具体实施方案对本发明作了详尽的描述,但在本发明基础上,可以对之作一些修改或改进,这对本领域技术人员而言是显而易见的。因此,在不偏离本发明精神的基础上所做的这些修改或改进,均属于本发明要求保护的范围。
Claims (10)
1.一种医用液态肠内营养组合物的制备方法,其特征在于,包括:
1)脂肪乳制备
①按配比称取蛋白质、水溶性乳化剂,加入至40~60℃纯水中,搅拌至完全溶解,得蛋白相;
②按配比称取脂肪、油溶性乳化剂,于40~80℃搅拌至混匀,得油相;
③将步骤②所得油相加至步骤①所得蛋白相中,剪切搅拌;将所得料液均质,得脂肪乳;
2)按配比称取碳水化合物、膳食纤维、稳定剂,加入至40~60℃纯水中,搅拌至完全溶解,得料液A;
3)将所述料液A加入至上述脂肪乳中,混合均匀,得料液B;
4)按配比称取矿物质预混料一,加入至40~60℃纯水中,搅拌完全溶解后,加至所述料液B中,混合均匀,得料液C;其中,矿物质预混料一中含铜、镁、铁和锌元素;
5)按配比称取矿物质预混料二,加入至40~60℃纯水中,搅拌完全溶解后,以不高于23L/min的流速加入至所述料液C中,混合均匀,得料液D;其中,矿物质预混料二中含钠、钾、锰、钙、磷、氯和硒元素;
6)按配比称取维生素预混料,加入至25~40℃纯水中,搅拌完全溶解后,以不高于12L/min的流速加入至所述料液D中,混合均匀,得料液E;
7)将所述料液E冷却至30℃以下,得料液F;
8)将所述料液F均质,过滤;或者进一步还包括将过滤后所得料液灭菌、灌装的步骤。
2.根据权利要求1所述的制备方法,其特征在于,步骤1)所述均质压力为15~35MPa,温度为50~70℃;更优选均质1~2次;和/或,
步骤5)所述流速为12L/min、15L/min、20L/min、21L/min或23L/min;或者为12-21L/min;和/或,
步骤6)所述流速为7L/min、8.5L/min、10L/min或12L/min,或者为7-8.5L/min;和/或,
步骤8)所述均质压力为15~35MPa,温度为50~70℃;均质1~2次。
3.根据权利要求1或2所述的制备方法,其特征在于,所述蛋白质选自浓缩牛奶蛋白、大豆分离蛋白、酪蛋白、水解乳清蛋白、大豆肽、浓缩乳清蛋白、分离乳清蛋白、酪蛋白酸钠、酪蛋白酸钙、豌豆蛋白、胶原蛋白肽中的一种或几种;和/或,
所述脂肪选自低芥酸菜籽油、玉米油、椰子油、高油酸葵花籽油、中链甘油三酯、大豆油、花生油、亚麻籽油、紫苏籽油、棕榈油、DHA藻油、鱼油中的一种或几种;和/或,
所述碳水化合物选自葡萄糖浆、葡萄糖浆干粉、麦芽糊精、蔗糖、葡萄糖、果糖中的一种或几种;和/或,
所述膳食纤维选自菊粉、聚葡萄糖、低聚半乳糖、低聚果糖、多聚果糖、棉籽糖、水苏糖、抗性糊精、抗性淀粉、大豆多糖中的一种或几种;和/或,
所述维生素预混料中含有以下任一种或几种组分:维生素A、维生素D、维生素E、维生素K1、维生素B1、维生素B2、维生素B6、维生素B12、烟酰胺、叶酸、泛酸、维生素C、生物素和碘;和/或,
所述水溶性乳化剂选自聚甘油脂肪酸酯、蔗糖脂肪酸酯、双乙酰酒石酸单双甘油酯中的一种或几种;所述油溶性乳化剂选自大豆磷脂、单双甘油脂肪酸酯、琥珀酸单甘油酯中的一种或几种;和/或,
所述稳定剂选自卡拉胶、微晶纤维素、羧甲基纤维素钠、黄原胶、结冷胶、果胶、羟丙基淀粉、刺槐豆胶中的一种或几种。
4.根据权利要求1-3任一项所述的制备方法,其特征在于,所述矿物质预混料一中各组分及其含量如下所示:
和/或,所述矿物质预混料二中各组分及其含量如下所示:
5.根据权利要求1-4任一项所述的制备方法,其特征在于,每1L该肠内营养组合物配方:蛋白质36.25~83.05g,脂肪23.7~56.2g、碳水化合物(以干基计)103.5~245.7g、膳食纤维0~41.5g、维生素预混料0.36~0.87g、矿物质预混料一1.86~4.58g、矿物质预混料二14.24~31.49g、乳化剂0.72~4.19g、稳定剂0.68~2.75g;溶剂为水。
6.权利要求1-5任一项所述方法制备的医用液态肠内营养组合物。
7.根据权利要求6所述的医用液态肠内营养组合物,其特征在于,每1L该肠内营养组合物含有如下组分:
8.根据权利要求6或7所述的医用液态肠内营养组合物,其特征在于,所述医用肠内营养组合物的粒径不高于650nm;优选为230~420nm。
9.根据权利要求6-8任一项所述的医用液态肠内营养组合物,其特征在于,所述医用肠内营养组合物的ζ-电位不低于-20mV;优选为-25~-35mV。
10.权利要求6-8任一项所述的医用肠内营养组合物在制备肠内营养制剂方面的应用。
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