CN108308608A - 一种适用于血液透析肾病患者的全营养配方液 - Google Patents
一种适用于血液透析肾病患者的全营养配方液 Download PDFInfo
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- CN108308608A CN108308608A CN201810212452.4A CN201810212452A CN108308608A CN 108308608 A CN108308608 A CN 108308608A CN 201810212452 A CN201810212452 A CN 201810212452A CN 108308608 A CN108308608 A CN 108308608A
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Abstract
本发明涉及一种适用于血液透析肾病患者的全营养配方液及其制备方法,以全营养配方液的总量为100ml计,其包含:蛋白质5.5~10.0g、脂肪7.6~12.6g、碳水化合物12.8~18.6g、膳食纤维0.6~2.6g、维生素60~180mg、无机盐275~525mg,特异性营养补充剂30~60mg、水50~70g;本发明产品特点是:通过多种人体所需维生素和特异性营养补充剂的复配,各成分的比例适当,能够提供安全、符合透析慢性肾病患者的生理需要,并且具有平稳血糖、减轻肾脏负担的作用,尤其适用于血液透析的肾病患者,能够改善患者的营养状况和生活质量。本发明产品的生产工艺简单,原料来源广泛,携带方便,食用简便。
Description
技术领域
本发明涉及临床营养特殊医学用途配方食品领域,具体涉及一种适用于血液透析肾病患者的全营养配方液及其制备方法。
背景技术
肾脏的基本功能是排泄代谢废物和水分,患有慢性肾脏病会导致代谢废物和水分潴留等系列症状和体征,危机患者的生命。终末期肾脏病患者需要进行肾脏替代治疗。肾脏替代治疗方式当前主要有血液透析、腹膜透析和肾移植。
我国慢性肾脏病呈现知晓率20%左右,患病率10%-11%左右,慢性肾脏病患者接近1.2亿,慢性肾脏病治疗率低5%,终末期肾脏病患者200万左右,透析人数34万左右,透析率低于20%,致病原因主要是原发性肾小球病接近50%,其次是糖尿病肾病和高血压肾硬化等。我国慢性肾脏病构成谱区别于发达国家,但逐渐向发达国家靠近,糖尿病肾病比例逐渐上升,特别是老年人慢性肾脏病患者群体。
慢性肾脏病的病因不同国家、不同地区、不同人种的病因构成有差别,主要有原发性与继发性肾小球肾炎(如糖尿病肾病、高血压肾小动脉硬化、狼疮性肾炎等)、肾小管间质病变(慢性肾盂肾炎、慢性尿酸性肾病、梗阻性肾病、药物性肾病等)、肾血管病变、遗传性肾病(如多囊肾、遗传性肾炎)等。在发达国家,糖尿病肾病、高血压肾小动脉硬化已成为慢性肾脏病的主要病因,在发展中国家,这两种疾病在慢性肾脏病各种病因中仍位居原发性肾小球肾炎之后,但近年也有明显增高趋势。双侧肾动脉狭窄或闭塞所引起的“缺血性肾病”,在老年慢性肾脏病的病因中占有较重要的地位。
《肾脏病学》(第三版)预防措施与CKD分期治疗方式指出,对于第5期终末期肾病患者,预防措施强调了及时检出营养不良并给予干预措施,减少因营养不良导致的死亡。透析患者出现营养不良,可加重贫血,降低免疫功能,还易出现感染,并对脑、肺、心等器官正常功能产生影响,降低生活质量,提升病死率。相关研究显示,美国血液透析患者营养不良发生率为32%,法国35%,巴西65%。经国内相关研究得知,我国由透析而发生营养不良率为53.4%,轻、中度占39.2%,重度14.2%。此外,根据2005年美国肾脏病学杂志的报道,约30-50%透析患者存在蛋白质-能量营养不良,而尿毒症患者的营养不良与其死亡和住院事件风险增加密切相关,由此可见,营养状态也是血液透析肾病患者临床预后的重要预测因子。
特殊医学用途配方食品(foods for special medical purposes,FSMP)是指为了满足进食受限、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。在营养支持产品中,全营养配方产品是可作为单一营养来源满足目标人群营养需求的特殊医学用途配方食品。
中华人民共和国国家卫生与计划生育委员会与2013年12月26日发布、2014年7月1日实施的《特殊医学用途配方食品通则》(GB29922-2013)以及后续发布的相应问答中规定:肾病病人用全营养配方食品适用于成人慢性肾脏病患者,配方根据透析或非透析慢性肾脏病患者对营养素的不同需求,通过调整蛋白质及电解质的水平,以满足其营养需要。对于透析治疗的患者,产品配方具体技术要求如下:
配方中蛋白质含量应不低于3.3g/100kcal,营养素调整的范围包含:钾(41-267mg/100kcal)、钠(30-168mg/100kcal)、磷(26-68mg/100kcal)、镁(>7.5mg/100kcal)、钙(35-133mg/100kcal)和维生素A(<225μgRE/100kcal)。上述规定为血液透析肾病患者用全营养配方食品的研究开发奠定了基础。
关于透析肾病患者用全营养配方食品,相关中国专利文献有:CN104082662A涉及一种需要透析的慢性肾病患者适用的营养液及制备方法,具体限定了L-肉碱与L-牛磺酸的重量比为10∶9以及含有0.1-1%的鱼油来源的脂肪。CN105211868A涉及一种适合肾病透析患者的代餐粉及其制备方法,其主要是以莲藕、小米、荞麦、山药、马铃薯、板栗、薏米、黑米、燕麦等食物粉碎并添加食品原料混合而成,该类代餐粉不能完全保证每一批次中营养素含量的均一稳定。CN105519961A涉及一种用于透析患者的肠内营养制剂及其制备方法,具体限定了蛋白质的成分均为多肽类物质,包括海参肽、大豆蛋白肽、乳清蛋白肽以及规定了海参肽中平均分子量低于2000Da的组分大于85%。
以上技术均存在一定的缺点,如各种营养素和微量元素搭配不够均衡,增加患者肾脏负担;为达到快速降糖目的大量添加中药提取物,这是国家标准中不允许添加的;制备方法过于复杂;产品口感和风味不佳等。
技术内容
针对现有技术的不足,本发明的目的在于提供一种适用于血液透析肾病患者的全营养配方液及其制备方法。
为了实现上述目的,本发明采用下述技术方案:
第一方面,本发明涉及一种适用于血液透析肾病患者的全营养配方液,以全营养配方液的总量为100ml计,其包含:蛋白质5.5~10.0g、脂肪7.6~12.6g、碳水化合物12.8~18.6g、膳食纤维0.6~2.6g、维生素60~180mg、无机盐275~525mg,特异性营养补充剂30~60mg、水50~75g;
其中,所述蛋白质包含:酪蛋白钙、酪蛋白钠和乳清蛋白;
所述脂肪包含:红花籽油、菜籽油和中链甘油三酯,但不含反式脂肪,并且饱和脂肪的含量为总脂肪的5%~25%;
所述碳水化合物包含:麦芽糊精、白砂糖和异麦芽酮糖;
所述膳食纤维包含:低聚果糖、抗性糊精;
所述维生素包含:维生素A、维生素B1、维生素B2、维生素B6、维生素B12、维生素C、维生素D、维生素E、维生素K、生物素、胆碱、烟酸、叶酸和泛酸。
所述无机盐包含:柠檬酸钠、氯化镁、柠檬酸钾、氯化钾、葡萄糖酸锌、磷酸氢二钾、氧化镁、硫酸亚铁、硫酸锰、硫酸铜、氯化铬、硒酸钠、钼酸钠和碘化钾。
所述特异性营养补充剂包含:牛磺酸和L-肉碱。
作为优选技术方案之一,以全营养配方液的总量为100ml计,其包含:蛋白质6.5~8.5g、脂肪8.4~10.6g、碳水化合物13.6~17.1g、膳食纤维1.1~2.1g、维生素65~175mg、无机盐325~500mg,特异性营养补充剂32~56mg、水55~75g。
作为优选方案之一,以全营养配方液的总量为100ml计,其包含:蛋白质7.0~8.0g(优选为7.7g)、脂肪8.5~9.6g(优选为9g)、碳水化合物14.5~16.8g(优选为15.2g)、膳食纤维1.4~1.8g(优选为1.6g)、维生素70~145mg(优选为85mg)、无机盐375~485mg(优选为440mg),特异性营养补充剂35~45mg(优选为41mg)、水60~70g(优选为67g)。
作为优选方案之一,以全营养配方液的总量为100ml计,所述蛋白质包含:酪蛋白钙2.5~4.5g(优选为3.5g)、酪蛋白钠1.8~3g(优选为2.4g)和乳清蛋白1.2~2.5g(优选为1.8g)。
作为优选方案之一,以全营养配方液的总量为100ml计,所述脂肪包含:红花籽油6.1~8.7g(优选为6.2g)、菜籽油1.4g~3.4g(优选为2.4g)和中链甘油三酯0.1~0.5g(优选为0.4g)。其中,饱和脂肪的含量为总脂肪的8.5%~12%(优选10%)。
作为优选方案之一,以全营养配方液的总量为100ml计,所述膳食纤维包含:低聚果糖0.28~1.62g(优选为1.08g)和抗性糊精0.32~0.98g(优选为0.52g)。
作为优选方案之一,以全营养配方液的总量为100ml计,所述维生素包含:维生素A90~126μg(优选为106μg)、维生素B10.05~0.35mg(优选为0.26mg)、维生素B20.05~0.35mg(优选为0.26mg)、维生素B60.72~1.28mg(优选为0.91mg)、维生素B120.48~1.35μg(优选为0.93μg)、维生素C 5~22mg(优选为12.4mg)、维生素D 0.1~9μg(优选为1.2μg)、维生素E 2.8~10mg(优选为6.2mg)、维生素K 6~15μg(优选为9μg)、生物素1~70μg(优选为48μg)、胆碱28~86mg(优选为58mg)和烟酸1~5mg(优选为3.02mg)、叶酸60~152μg(优选为100μg)和泛酸0.5~2.5mg(优选为1.5mg)。
作为优选方案之一,以全营养配方液的总量为100ml计,所述特异性营养补充剂包含:牛磺酸10~25mg(优选15mg)和L-肉碱20~35(优选26mg)。
作为优选方案之一,以全营养配方液的总量为100ml计,所述无机盐包含:柠檬酸钠0.01~1.0g(优选为0.18g)、氯化镁0.001~0.1g(优选为0.04g)、柠檬酸钾0.01~1.0g(优选为0.1g)、氯化钾0.01~1.0g(优选为0.1g)、葡萄糖酸锌0.0001~0.01g(优选为0.0035g)、磷酸氢二钾0.001~0.1g(优选为0.02g)、氧化镁0.001~0.1g(优选为0.04g)、硫酸亚铁0.0001~0.01g(优选为0.006g)、硫酸锰0.0001~0.01g(优选为0.002g)、硫酸铜0.00001~0.001g(优选为0.0004g)、氯化铬0.00001~0.001g(优选为0.00015g)、硒酸钠0.000001~0.0001g(优选为0.000015g)、钼酸钠0.000001~0.0001g(优选为0.00003g)和碘化钾0.000001~0.0001g(优选为0.00002g)。以上重量均以全营养配方液的总量为100ml计。
第二方面,本发明提供一种适用于血液透析肾病患者的全营养配方液的制备方法,包括将上述各成分混合均匀;
优选地,所述的制备方法包括以下步骤:
(1)制备以下溶液:
溶液A:由脂肪(红花籽油、菜籽油和中链甘油三酯)、乳化剂(卡拉胶)、卵磷脂和脂溶性维生素预混料组成,其中脂溶性维生素预混料由维生素A、维生素D、维生素E、维生素K组成;
溶液B:由蛋白质(酪蛋白钙、酪蛋白钠和乳清蛋白)和水组成;
溶液C:由水、碳水化合物(麦芽糊精)、膳食纤维(低聚果糖、抗性糊精)、和浓度为35%的氢氧化钾组成;
溶液D:由非脂溶性维生素(维生素C、胆碱、烟酸、维生素B12、泛酸、维生素B1、维生素B6、维生素B2、叶酸、生物素)和水组成;
溶液E:由无机盐(柠檬酸钠、氯化镁、柠檬酸钾、氯化钾、葡萄糖酸锌、磷酸氢二钾、氧化镁、硫酸亚铁、硫酸锰、硫酸铜、氯化铬、硒酸钠、钼酸钠和碘化钾)和水组成;
溶液F:由水、特异性营养补充剂和调味剂组成,优选由水、牛磺酸、L-肉碱和食用香料组成;将溶液A、B、C、D、E和F混合后在55-65℃下搅拌,调节pH至6.5-6.8;
(2)将步骤(1)得到的混合物加热至70-75℃,0.1-0.2MPa下脱气,后于8-10MPa下乳化后加热至98-102℃,后加热至146-147℃,保持3-8秒;
(3)将步骤(2)得到的混合物冷却至98-102℃;后基板散热降温至70-75℃,
(4)在氮气的保护下,将步骤(3)得到的混合物在30-50MPa压力下均质,后在70-80℃下保持13-20秒,后冷却至2-6℃,即得。
技术效果
本发明所述的适用于血液透析肾病患者的全营养配方液中,包含人体所需的各种营养素,即蛋白质、脂类、碳水化合物、维生素、无机盐和膳食纤维。
本发明的适用于血液透析肾病患者的全营养配方液中通过多种人体所需维生素和特异性营养补充剂的复配,不仅提供全面的营养支持,并且可达到提高提高机体免疫力、改善人体代谢,快速补充血液透析后患者营养丢失,同时对于人体的血糖代谢以及促进脂肪转化起到突出的效果。作为特异性营养补充剂的牛磺酸是人体不可缺少的氨基酸,具有维持正常视觉功能、维持渗透压平衡、维持细胞膜温度、降血糖、保护组织缺血再灌注损伤、提高机体免疫力、调节脂类分泌、保护心肌细胞等广泛的生物学作用。此外,牛磺酸还有助于帮助细胞膜形成及胆酸进行脂肪乳化。肉碱的主要生理功能是促进脂肪转化成能量,利于减少人体脂肪堆积。
本发明产品包含多种膳食纤维,包含低聚果糖和抗性糊精,能够有效促进消化、调节血糖并减少消化过程中对脂肪的吸收。
本发明产品中的蛋白质100%来源于优质蛋白质,其中富含精氨酸和支链氨基酸,有助于增加蛋白质合成、预防分解代谢,促进细胞与组织的修复,有利于增强机体免疫力,特别是针对血液透析后蛋白质的大量丢失能够迅速补充且尽可能减轻肝脏负担。
本发明产品各成分的比例适当,能够提供安全均衡、符合透析肾病患者生理需要的各种营养素和微量元素,能够改善血液透析肾病患者的营养状况和生活质量。
本发明生产工艺简单,原料来源广泛,携带方便,食用简便;且用途广泛,可作为辅食,也可作为单一营养来源食用。
具体实施方式
下面结合具体实施方式对本发明进行进一步的详细描述,给出的实施例仅为了阐明本发明,而不是为了限制本发明的范围。
实施例1:本发明的适用于血液透析肾病患者的全营养配方液的制备
1、原料配方如表1所示:
表1:适用于血液透析肾病患者的全营养配方液的制备原料
2、制备方法
(1)制备以下溶液:
溶液A:由脂肪(红花籽油、菜籽油和中链甘油三酯)、乳化剂(卡拉胶)、卵磷脂和脂溶性维生素预混料组成,其中脂溶性维生素预混料由维生素A、维生素D、维生素E、维生素K组成;
溶液B:由蛋白质(酪蛋白钙、酪蛋白钠和乳清蛋白)和水组成;
溶液C:由水、碳水化合物(麦芽糊精)、膳食纤维(低聚果糖、抗性糊精)、和浓度为35%的氢氧化钾组成;
溶液D:由非脂溶性维生素(维生素C、胆碱、烟酸、维生素B12、泛酸、维生素B1、维生素B6、维生素B2、叶酸、生物素)和水组成;
溶液E:由无机盐(柠檬酸钠、氯化镁、柠檬酸钾、氯化钾、葡萄糖酸锌、磷酸氢二钾、氧化镁、硫酸亚铁、硫酸锰、硫酸铜、氯化铬、硒酸钠、钼酸钠和碘化钾)和水组成;
溶液F:由水、特异性营养补充剂和调味剂组成,优选由水、牛磺酸、L-肉碱和食用香料组成;将溶液A、B、C、D、E和F混合后在55-65℃下搅拌,调节pH至6.5-6.8;
(2)将步骤(1)得到的混合物加热至70-75℃,0.1-0.2MPa下脱气,后于8-10MPa下乳化后加热至98-102℃,后加热至146-147℃,保持3-8秒;
(3)将步骤(2)得到的混合物冷却至98-102℃;后基板散热降温至70-75℃.
(4)在氮气的保护下,将步骤(3)得到的混合物在30-50MPa压力下均质,后在70-80℃下保持13-20秒,后冷却至2-6℃,即得。
需要说明的是,最终产品中的水为上述溶液B~F配制中使用的水的用量的总和,关于溶液B~F中各自使用的水量,以能够将相应的营养物质全部均匀地溶解为原则进行分配。
本实施例制备得到的适用于血液透析肾病患者的全营养配方液的检测结果如表2:
表2:本实施例的全营养配方液检测结果
实施例2:本发明的适用于血液透析肾病患者的全营养配方液的制备
1、原料配方如表3所示:
表3:适用于血液透析肾病患者的全营养配方液的制备原料
2、制备方法
同实施例1的制备方法,按照表3中的原料配比进行制备。
本实施例制备得到的适用于血液透析肾病患者的全营养配方液的检测结果如表4:
表4:本实施例的全营养配方液检测结果
效果评价
效果例1、营养指标评价
以实施例1和2得到的适用于血液透析肾病患者的全营养配方液为例,将其与《食品安全国家标准特殊医学用途配方食品通则》GB29922-2013规定的各项指标逐一对照,发现均符合要求。
效果例2、血液透析肾病患者服用效果试验
随机选取120名受试者,纳入研究对象为年龄在18岁以上;预计血液透析1个月以上,每周2-3次;伴有营养不良,SGA-B级或以上、白蛋白<3.7g/dL、前白蛋白<30mg/dL。存在胃肠功能障碍、肠梗阻、幽门梗阻患者,或者妊娠或哺乳的妇女不纳入研究中。将志愿者随机分为3组,每组40人。各组受试者分别给予实施例1、2及雅培全安素全营养配方粉(对比例)。对比例按照产品标签中描述的配制方法进行配置,即可得对比例的配方液。
服用方法:各组受试者每次透析完成后服用配方液250ml,服用持续一个月,其他透析治疗方法的影响因素(如其他进食物、活动量、药物摄入)控制等比相同,比较血中白蛋白、前白蛋白改善情况,调查有效率,结果如表5:
表5血液透析肾病患者服用效果
实施例1 | 实施例2 | 对比例 | |
参与试验人数 | 40 | 40 | 40 |
白蛋白平均值显著提升人数 | 25 | 24 | 18 |
白蛋白平均值提升幅度 | 25.8% | 24.6% | 20.6% |
前白蛋白平均值显著提升人数 | 29 | 28 | 26 |
前白蛋白平均值提升幅度 | 26.1% | 23.7% | 22.6% |
以上对本发明具体实施方式的描述并不限制本发明,本领域技术人员可以根据本发明作出各种改变或变形,只要不脱离本发明的精神,均应属于本发明所附权利要求的范围。
Claims (10)
1.一种适用于血液透析肾病患者的全营养配方液,以全营养配方液的总量为100ml计,其包含:蛋白质5.5~10.0g、脂肪7.6~12.6g、碳水化合物12.8~18.6g、膳食纤维0.6~2.6g、维生素60~180mg、无机盐275~525mg,特异性营养补充剂30~60mg、水50~75g;
其中,所述蛋白质包含:酪蛋白钙、酪蛋白钠和乳清蛋白;
所述脂肪包含:红花籽油、菜籽油和中链甘油三酯,但不含反式脂肪,并且饱和脂肪的含量为总脂肪的5%~25%;
所述碳水化合物包含:麦芽糊精、白砂糖和异麦芽酮糖;
所述膳食纤维包含:低聚果糖、抗性糊精;
所述维生素包含:维生素A、维生素B1、维生素B2、维生素B6、维生素B12、维生素C、维生素D、维生素E、维生素K、生物素、胆碱、烟酸、叶酸和泛酸。
所述无机盐包含:柠檬酸钠、氯化镁、柠檬酸钾、氯化钾、葡萄糖酸锌、磷酸氢二钾、氧化镁、硫酸亚铁、硫酸锰、硫酸铜、氯化铬、硒酸钠、钼酸钠和碘化钾。
所述特异性营养补充剂包含:牛磺酸和L-肉碱。
2.根据权利要求1所述的适用于血液透析肾病患者的全营养配方液,以全营养配方液的总量为100ml计,其包含:蛋白质6.5~8.5g、脂肪8.4~10.6g、碳水化合物13.6~17.1g、膳食纤维1.1~2.1g、维生素65~175mg、无机盐325~500mg,特异性营养补充剂32~56mg、水55~75g。
3.根据权利要求1或2所述的适用于血液透析肾病患者的全营养配方液,以全营养配方液的总量为100ml计,其包含:蛋白质7.0~8.0g(优选为7.7g)、脂肪8.5~9.6g(优选为9g)、碳水化合物14.5~16.8g(优选为15.2g)、膳食纤维1.4~1.8g(优选为1.6g)、维生素70~145mg(优选为85mg)、无机盐375~485mg(优选为440mg),特异性营养补充剂35~45mg(优选为41mg)、水60~70g(优选为67g)。
4.根据权利要求1-3任一项所述的适用于血液透析肾病患者的全营养配方液,以全营养配方液的总量为100ml计,所述蛋白质包含:酪蛋白钙2.5~4.5g(优选为3.5g)、酪蛋白钠1.8~3g(优选为2.4g)和乳清蛋白1.2~2.5g(优选为1.8g)。
5.根据权利要求1-4任一项所述的适用于血液透析肾病患者的全营养配方液,以全营养配方液的总量为100ml计,所述脂肪包含:红花籽油6.1~8.7g(优选为6.2g)、菜籽油1.4g~3.4g(优选为2.4g)和中链甘油三酯0.1~0.5g(优选为0.4g)。其中,饱和脂肪的含量为总脂肪的8.5%~12%(优选10%)。
6.根据权利要求1-5任一项所述的适用于血液透析肾病患者的全营养配方液,以全营养配方液的总量为100ml计,所述膳食纤维包含:低聚果糖0.28~1.62g(优选为1.08g)和抗性糊精0.32~0.98g(优选为0.52g)。
7.根据权利要求1-6任一项所述的适用于血液透析肾病患者的全营养配方液,以全营养配方液的总量为100ml计,所述维生素包含:维生素A 90~126μg(优选为106μg)、维生素B1 0.05~0.35mg(优选为0.26mg)、维生素B2 0.05~0.35mg(优选为0.26mg)、维生素B60.72~1.28mg(优选为0.91mg)、维生素B12 0.48~1.35μg(优选为0.93μg)、维生素C 5~22mg(优选为12.4mg)、维生素D 0.1~9μg(优选为1.2μg)、维生素E 2.8~10mg(优选为6.2mg)、维生素K 6~15μg(优选为9μg)、生物素1~70μg(优选为48μg)、胆碱28~86mg(优选为58mg)和烟酸1~5mg(优选为3.02mg)、叶酸60~152μg(优选为100μg)和泛酸0.5~2.5mg(优选为1.5mg)。
8.根据权利要求1-7任一项所述的适用于血液透析肾病患者的全营养配方液,以全营养配方液的总量为100ml计,所述特异性营养补充剂包含:牛磺酸10~25mg(优选15mg)和L-肉碱20~35(优选26mg)。
9.根据权利要求1-8任一项所述的适用于血液透析肾病患者的全营养配方液,以全营养配方液的总量为100ml计,所述无机盐包含:柠檬酸钠0.01~1.0g(优选为0.18g)、氯化镁0.001~0.1g(优选为0.04g)、柠檬酸钾0.01~1.0g(优选为0.1g)、氯化钾0.01~1.0g(优选为0.1g)、葡萄糖酸锌0.0001~0.01g(优选为0.0035g)、磷酸氢二钾0.001~0.1g(优选为0.02g)、氧化镁0.001~0.1g(优选为0.04g)、硫酸亚铁0.0001~0.01g(优选为0.006g)、硫酸锰0.0001~0.01g(优选为0.002g)、硫酸铜0.00001~0.001g(优选为0.0004g)、氯化铬0.00001~0.001g(优选为0.00015g)、硒酸钠0.000001~0.0001g(优选为0.000015g)、钼酸钠0.000001~0.0001g(优选为0.00003g)和碘化钾0.000001~0.0001g(优选为0.00002g)。
10.权利要求1-9任一项的适用于血液透析肾病患者的全营养配方液的制备方法,包括将上述各成分混合均匀;
优选地,所述肠内营养剂的制备方法包括以下步骤:
(1)制备以下溶液:
溶液A:由脂肪(红花籽油、菜籽油和中链甘油三酯)、乳化剂(卡拉胶)、卵磷脂和脂溶性维生素预混料组成,其中脂溶性维生素预混料由维生素A、维生素D、维生素E、维生素K组成;
溶液B:由蛋白质(酪蛋白钙、酪蛋白钠和乳清蛋白)和水组成;
溶液C:由水、碳水化合物(麦芽糊精)、膳食纤维(低聚果糖、抗性糊精)、和浓度为35%的氢氧化钾组成;
溶液D:由非脂溶性维生素(维生素C、胆碱、烟酸、维生素B12、泛酸、维生素B1、维生素B6、维生素B2、叶酸、生物素)和水组成;
溶液E:由无机盐(柠檬酸钠、氯化镁、柠檬酸钾、氯化钾、葡萄糖酸锌、磷酸氢二钾、氧化镁、硫酸亚铁、硫酸锰、硫酸铜、氯化铬、硒酸钠、钼酸钠和碘化钾)和水组成;
溶液F:由水、特异性营养补充剂和调味剂组成,优选由水、牛磺酸、L-肉碱和食用香料组成;将溶液A、B、C、D、E和F混合后在55-65℃下搅拌,调节pH至6.5-6.8;
(2)将步骤(1)得到的混合物加热至70-75℃,0.1-0.2MPa下脱气,后于8-10MPa下乳化后加热至98-102℃,后加热至146-147℃,保持3-8秒;
(3)将步骤(2)得到的混合物冷却至98-102℃;后基板散热降温至70-75℃,
(4)在氮气的保护下,将步骤(3)得到的混合物在30-50MPa压力下均质,后在70-80℃下保持13-20秒,后冷却至2-6℃,即得。
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