CN115024495A - 改善肾病患者钙磷代谢的营养组合物及其应用 - Google Patents
改善肾病患者钙磷代谢的营养组合物及其应用 Download PDFInfo
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Abstract
本发明属于医药技术领域,公开了一种改善肾病患者钙磷代谢的营养组合物及其应用。其中,营养组合物,按照重量份数计,包括:烟酸1.00~4.95重量份;硫胺素6.70~16.00重量份;有机酸铁盐10~20重量份;含钙营养强化剂15~30重量份;以及辅料35~65重量份;其中,所述含钙营养强化剂为β‑羟基‑β‑甲基丁酸钙。采用本发明有针对性地进行营养干预,不仅可以降低血磷,补充钙、铁元素,维持肾病患者体内钙磷代谢的平衡,还可改善患者负氮平衡状态,可降低患者营养不良的发生风险,延缓肾脏病变的进行性加重,改善患者的预后。
Description
技术领域
本发明涉及医药技术领域,特别是涉及一种改善肾病患者钙磷代谢的营养组合物及其应用。
背景技术
慢性肾脏病是不同病因造成肾功能损害且病程不少于3个月的一种疾病,是严重危害人类健康的主要疾病之一。慢性肾脏病患者随着病情的发展中,均会出现不同程度的钙磷代谢紊乱,甚至由于钙磷代谢的紊乱而引起心血管钙化、甲状旁腺功能亢进及心脑血管意外的发生,是直接影响慢性肾脏病患者死亡率的因素。目前对于慢性肾病患者的钙磷代谢紊乱的控制率较低,并且由于钙磷代谢紊乱发生发展过程中并无特异性的不适表现,往往不被患者重视。
实际上,作为人体中最基本元素,钙和磷不但涉及细胞、组织的构成,而且对于人体细胞、组织、器官甚至整体代谢水平上均有着重要的影响。钙约占人体重的1.5%~2.0%左右,其中99%钙存在于骨骼和牙齿中,血液中的钙含量约占总钙量的0.1%,其他则分布于组织和细胞外液中,是人体生理过程至关重要的元素;钙对骨质代谢、腺体细胞分泌、凝血功能、肌电活动及机械活动、神经元兴奋及传递具有不可或缺的作用;正常成年人钙的吸收量与机体的需要量是相适应的,约为1200mg/日,当缺钙时肠道吸收钙的速度增加,而当体内钙过多时,则吸收速度降低;摄入的钙80%从粪便排出,20%从肾排出。成年人体中磷的含量约为700克,其中85%以不溶性磷酸盐的形式沉积于骨骼和牙齿中,15%主要集中在细胞内液中,只有不到0.1%磷存在于细胞外液,是骨骼、磷脂和核酸的主要组成部分;它是细胞内液中含量最多的阴离子,是构成骨质、核酸的基本成份,既是肌体内代谢过程的储能和释能物质,又是细胞内的主要缓冲剂;正常成人每天从饮食摄入1~1.5g的磷,通过钠依赖性和钠非依赖性途径吸收,肾和肠道是机体磷排泄的主要器官。
由于肾脏的病变,肾病患者普遍存在钙磷代谢的紊乱。在轻微肾脏功能损害(CKD1-3期)时,通过代偿,血清中钙磷浓度仍然可以维持在正常范围;到CKD4期以后,血清磷升高的发生率显著性上升;到CKD5期患者的血清钙水平会发生显著性降低,特征性表现为高磷血症和低钙血症。同时人体中钙、磷的代谢相互影响,钙磷代谢紊乱的危害不仅涉及骨骼系统的病变,还会引起继发性甲状旁腺功能亢进症、血管及心脏瓣膜钙化、甚至心律失常、心力衰竭、脑血管疾病等致死性并发症。
为了增加磷的排泄,达到降低血磷的目的,早期曾使用含铝的磷结合剂,但是由于副作用较大,可导致铝中毒目前已较少使用。碳酸钙和醋酸钙等含钙磷结合剂的单纯使用很容易会导致血清钙水平升高、出现血管钙化增多等现象,甚至引起心血管死亡风险增加。
因此,近年来新型的改善钙磷代谢的研究一直是肾病领域的研究热点。例如,中国专利CN200610092802.5,CN200780004102.9,CN201310680466.6,CN200880111989.6,CN201510487315.8等提供了包括镧、铈、镁等金属化合物来改善钙磷代谢,但是镧系元素由于价格较高,导致患者的经济压力较大,而镁盐由于具有较明显的胃肠道反应,因此影响了患者的接受和使用。又如,中国专利CN201480055714.0,CN201610338264.7,CN201610338265.1,CN201610341392.7,CN201610341394.6等提供了铁的氢氧化物、柠檬酸铁、羟基氧化蔗糖铁等来改善钙磷代谢,但是这些药物的使用仍然会面对慢性肾病患者血钙降低,甚至发生肾性骨病,表现为骨钙减少、骨质疏松等症状。
本申请发明人认识到:改善肾病患者钙磷代谢障碍并非是单一元素的缺乏或蓄积,而是处于全身矿物质代谢、激素代谢调节基础上的全身性代谢失衡,因此在肾病患者的营养治疗中,有必要开发一种能够综合改善肾病患者钙磷代谢水平的营养组合物。
发明内容
本发明的目的在于提供一种改善肾病患者钙磷代谢的营养组合物及其应用,以针对性地进行营养干预,综合有效地改善肾病患者钙磷代谢水平,降低患者营养不良的发生风险,延缓肾脏病变的进行性加重,改善患者的预后。
上述目的可以是通过以下技术方案的实施方式实现:
根据本发明的一个方面,本发明提供的一种改善肾病患者钙磷代谢的营养组合物,按照重量份数计包括:烟酸1.00~4.95重量份;硫胺素6.70~16.00重量份;有机酸铁盐10~20重量份;含钙营养强化剂15~30重量份;以及辅料35~65重量份;其中,所述含钙营养强化剂为β-羟基-β-甲基丁酸钙。
可选地,所述有机酸铁盐选自甘氨酸亚铁、富马酸亚铁、柠檬酸亚铁、琥珀酸亚铁的一种。优选地,选择甘氨酸亚铁或柠檬酸亚铁。
可选地,所述辅料包括麦芽糊精、抗性糊精、聚葡萄糖、玉米淀粉、蔗糖、葡萄糖中的一种。
根据本发明的一个方面,本发明提供的一种改善肾病患者钙磷代谢的营养组合物的应用,将所述营养组合物制备成粉剂、片剂或液体制剂,应用到配方食品中。其中配方食品可为保健食品、特膳食品、特殊医学配方食品等。
本发明基于慢性肾病患者的生理状态和代谢特点,通过对患者钙磷代谢紊乱状态进行深入研究,通过从外源性和内源性两个角度出发进行血磷控制,并通过改进组分并优化配比,最终不仅可降低血磷,补充钙、铁元素,维持肾病患者体内钙磷代谢的平衡,同时还可改善患者负氮平衡状态。具体地,本发明至少具有以下突出的优点:
1、本发明的配方能够通过增加对食物中磷的结合,抑制肠道和肾小管对磷的吸收、增强细胞内含磷复合物的含量等手段,降低慢性肾病患者血液中磷的含量,有利于预防和治疗高磷血症引起的的危害;
2、本发明的配方能够适当补充钙和铁的供应,预防慢性肾病高血磷引起的低血钙和肾性贫血的发生;
3、本发明的配方能够有效降低蛋白尿的症状,能够增强机体的蛋白质合成反应,促进肌蛋白的合成,改善慢性肾病患者负氮平衡的状态。
附图说明
图1是本发明改善肾病患者钙磷代谢的营养组合物的作用原理示意图;
图2是本发明实施例各组大鼠显微镜下肾组织病理切片图。
具体实施方式
下面将结合本发明实施例,对本发明的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。以下对至少一个示例性实施例的描述实际上仅仅是说明性的,决不作为对本发明及其应用或使用的任何限制。基于本发明中的实施例,本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
本发明中提供的一种改善肾病患者钙磷代谢的营养组合物,按照重量份数计,包括:烟酸1.00~4.95重量份;硫胺素6.70~16.00重量份;有机酸铁盐10~20重量份;含钙营养强化剂15~30重量份;以及辅料35~65重量份。其中,所述含钙营养强化剂为β-羟基-β-甲基丁酸钙。所述有机酸铁盐可以选自甘氨酸亚铁、富马酸亚铁、柠檬酸亚铁、琥珀酸亚铁的一种或多种。所述辅料包括但不限于麦芽糊精、抗性糊精、聚葡萄糖、玉米淀粉、蔗糖、葡萄糖等。
该营养组合物可被制作为粉剂、颗粒剂、片剂、液体制剂等多种形式,可以单独使用来改善肾病患者钙磷代谢,也可以将其与其他营养素结合后制备成全营养素复配营养强化剂用于治疗慢性肾病患者的钙磷代谢紊乱,可应用于保健食品、特膳食品、特殊医学配方食品中。
本发明该营养组合物通过从外源性和内源性两个角度出发对血磷进行控制,通过改进组分并优化配比,不仅降低了血磷,补充了钙铁元素,维持肾病患者体内钙磷代谢的平衡,同时还改善了患者负氮平衡状态。图1示意性示出了本发明改善肾病患者钙磷代谢的营养组合物的作用原理,下面结合图1对本发明营养组合物中组分及组分间作用原理做进一步说明。
一是血磷的综合控制。肾病患者由于肾功能的损伤通常都会存在不同程度的血磷升高,本发明营养组合物从内源和外源两个角度出发对患者血磷进行综合调控,同时对有机酸铁盐和含钙营养强化剂组分和配比进行优化,并对烟酸和硫胺素组分和配比进行优化,明显降低了患者血磷。具体地,
(1)降低外源性磷的吸收:有机酸铁盐和β-羟基β-甲基丁酸钙在肠道弱碱性环境下解离后形成钙铁复合物,其与磷结合的能力显著增强,通过在胃肠道中与饮食中的磷相结合,从而减少食物中磷的吸收,并增加粪便排磷达到了降低血磷的目的。经过不断研究和改进,发明人发现,在采用10~20重量份有机酸铁盐和15~30重量份的含钙营养强化剂时,可以有效降低血磷且保证钙铁摄入值,从而可以更加有效地维持肾病患者体内钙磷代谢的平衡,有效地降低低钙低铁并发症。
(2)降低内源性磷的释放/回收:通过烟酸和硫胺素协同抑制内源性磷的释放/回收,通过烟酸抑制肠上皮粘膜细胞和肾小管上皮细胞的钠磷协同转运蛋白-2b(NaPi-2b),从而抑制磷酸盐在肾小管和小肠的重吸收,同时烟酸的代谢产物烟酰胺也参与烟酰胺腺嘌呤二核苷酸(NAD)和烟酰胺腺体嘌呤二核苷酸磷酸(NADP)的合成;硫胺素在人体内的存在形式为游离硫胺素和硫胺素的磷酸衍生物,单磷酸盐硫胺素(TMP)、焦磷酸硫胺素(TPP)和三磷酸硫胺素(TTP),其中最重要的是TPP,约占硫胺素总量的90%,通过烟酸与硫胺素来抑制慢性肾病患者内源性磷的重吸收和释放。经过不断研究和改进,发明人发现,在采用1.00~4.95重量份烟酸和6.70~16.00重量份的硫胺素时,可以实现磷酸盐转运的高效抑制,从而最有效地抑制性内源性磷的重吸收,同时促进肾病患者代谢,而且在二者协同控制下具有非排他性和非限制性,显著降低了肾病患者血磷,改善慢性肾病患者钙磷代谢的能力。
二是补充钙、铁的摄入。
本申请营养组合物中含钙营养强化剂采用的是β-羟基-β-甲基丁酸钙,而β-羟基β-甲基丁酸钙(CaHMB)作为HMB的钙盐,不但能够与所述有机酸铁盐形成钙铁复合物来结合磷,在肠道中也会有一定量游离的钙离子和铁粒子存在,这些离子的吸收可以在一定程度上改善慢性肾病患者血液中钙、铁降低导致的并发症;同时由于在肠道环境中钙铁复合物所形成的动态平衡,也可以防止血钙过高引起异位钙化等症状的出现。经过不断研究和改进,发明人发现,在采用15~30重量份的β-羟基β-甲基丁酸钙时,能够显著降低血磷且保证肾病患者的钙铁摄入值,从而降低了低钙低铁并发症和高钙症状的出现风险。
三是改善慢性肾病患者的负氮平衡状态。
本申请营养组合物中硫胺素可以显著的降低慢性肾病患者的蛋白尿,减少体内蛋白质的消耗;同时β-羟基-β-甲基丁酸钙(CaHMB)可以在体内分解后形成β-羟基-β-甲基丁酸(HMB)和钙,其中HMB是必需氨基酸亮氨酸在体内通过其代谢产物,能够增加机体氨基酸的利用,提高肌肉蛋白的合成,从而可以明显改善慢性肾病患者的负氮平衡状态。经过不断研究和改进,发明人发现,在采用15~30重量份的β-羟基β-甲基丁酸钙和6.70~16.00重量份的硫胺素时,通过促进蛋白质合成和抑制蛋白尿从而维持蛋白质含量,改善肾病患者负氮平衡的状态。
综上,本发明基于上述组分间的作用原理,通过对烟酸与硫胺素,有机酸铁盐与β-羟基β-甲基丁酸钙,以及硫胺素与β-羟基β-甲基丁酸钙的配比进行综合控制并优化,有针对性的进行营养干预,显著延缓肾脏病变的进行性加重,有效维持了肾病患者体内钙磷代谢的平衡,显著降低了患者营养不良以及低铁低钙、高钙等各病症的发生风险,改善患者的预后。
在可选实施例中,为了改善产品的适口性,所述营养组合物还可以包括添加剂,所述添加剂用量为0~20重量份。需要说明的是,所述添加剂仅为了改善产品的适口性,不与其他组分产生化学作用。所述添加剂可以为矫味剂、植物提取物、营养素或其他功能性成分来改善本发明的口感、营养结构和功能。具体地,例如,可以添加柠檬酸、苹果酸、琥珀酸、延胡索酸、酒石酸等酸味剂提高产品的风味可以添加柠檬酸钠、碳酸氢钠、酒石酸钠、酒石酸钠钾等盐类平衡营养组合物的pH,获得更适口的酸度。可以添加阿巴斯甜、安赛蜜、甜蜜素、三氯蔗糖等人工甜味剂或者蔗糖、果糖、蜂蜜、乳糖、葡萄糖,甜菊糖、海藻糖等天然甜味剂获得甜蜜的口感。可以添加草莓粉、蔓越莓粉、橙子粉、番茄粉等各种蔬果粉或果汁提高产品的风味。可以添加各种氨基酸、蛋白质、脂肪和碳水化合物以及其他维生素和矿物质等营养素,将本发明的营养组合物应用于全营养食品中。可以添加菊粉、聚葡萄糖、果蔬纤维、魔芋胶等功能性组分获得更加的产品特点。
下面结合具体实施例对本发明的技术方案做进一步说明:
实施例1-3、对比例1-2、以及对照组(阿霉素肾病模型组和健康正常的对照组),各例的配方如下表1所示。按照表1准确称取各组分后,在净化条件下,经过筛、三维混匀、封装工序配制得到各实施例对应产品。
表1实施例1-3、对比例、对照组配方
测试实验:
1)准备:雄性Wistar大鼠70只,6~8周,体质量(190+20)g,清洁级,按照随机数字表法分为7组,每组10只。
七组分别为:一组健康的正常对照组(采用对照组干预),和六组阿霉素肾病组。其中,六组阿霉素肾病组中,三组阿霉素肾病组以采用实施例1-3的营养组合物进行干预;两组阿霉素肾病组以采用对比例1-2进行干预;一组阿霉素肾病作为模型对照组以采用对照组进行干预。
2)营养干预:将实施例1~3以及对比例1~2的产品配置成水溶液,将该水溶液分别给予六组阿霉素肾病组大鼠进行干预,用量均为1mL/100g;阿霉素肾病模型对照组和健康的正常对照组均给予对照组溶液1mL/100g灌胃,每天一次,持续4周。
3)血清钙磷含量的检测:各实验组大鼠在处理4周后,尾静脉抽血检测血清中钙、磷含量,结果如下表2所示。
表2各组大鼠血清中钙、磷含量前后对比
从表2可以看出:在实施例1~3的三组营养组合物干预组中,大鼠的血清磷含量均有一定程度的降低,血清钙一定程度提升;而肾病模型对照组和健康的正常对照组对应的大鼠的血清磷含量变化不明显;而对比例1干预组对应大鼠的血清磷含量虽然也有所降低,但下降率仅为8.83%,显著低于实施例2干预组(下降率约35.9%);对比例2干预组的组合物中有效成分高于本发明配方的上限值,但其对应的大鼠的血清磷含量的下降率为35.96%,与实施例2相比的35.94%已无显著性差别,下降率不再提高,没有必要再增加有效成分的含量。综上,采用本发明实施例1~3营养组合物产品对存在肾功能障碍的大鼠进行干预,可改善大鼠的钙磷代谢水平。
4)各实验组大鼠肾组织病理学指标判断:各组实验大鼠处死后,取新鲜肾脏组织,多聚甲醛固定,石蜡包埋后,轮式切片机切成3.0~4.0μm的切片,在经过脱蜡透明后经苏木精-伊红(HE)染色后,显微镜(200×)观察并拍照,具体如图2所示,由左至右分别为阿霉素肾病模型对照组(即肾病模型组),实施例1营养组合物干预组(即营养干预组1),实施例2营养组合物干预组(即营养干预组2),实施例3营养组合物干预组(即营养干预组3),最右侧为健康的正常对照组。
从图2可以看出:最右侧正常对照组的肾组织:皮、髓质结构正常,肾小球未见充血及渗出等改变,肾小管结构正常。最左侧肾病模型组的肾组织:肾小球数量明显减少,残存肾小球,毛细血管萎缩,呈分叶状;肾小管上皮细胞变性,重度浊肿颗粒变性,少数细胞核固缩,以近曲小管为甚,肾小管扩张,可见较多的蛋白管型;大量肾小管管腔内可见棕褐色结晶体沉积;肾间质多灶状呈弥漫性淋巴、单核细胞浸润,伴有血管壁增厚。在实施例1-3的营养组合物干预组中,均表现为肾小管数量增多,上皮细胞呈立方状,核浆比正常;近曲小管形态大致正常,间质毛细血管充血,小灶区域见少数肾小管上皮细胞轻度增生。实施例3的营养干预组图中还可见肾小球相对饱满,球内系膜血管充血,肾小球囊间隙变小等病理变化。说明采用本发明不同实施例营养组合物干预后,虽然仍然存在肾结构破坏的表现,但是病理改变明显好于肾病模型组,可见,使用本发明营养组合物进行营养干预,能够延缓慢性肾病的发展进程。
另外,本发明改善肾病患者钙磷代谢的营养组合物还具有以下优点:1)基于肾病患者钙磷代谢障碍,从患者全身矿物质代谢、激素代谢调节基础上的全身性代谢失衡出发,利用现代医学、营养学和生物化学技术,提供了一种能够综合改善肾病患者钙磷代谢水平的营养组合物。2)以慢性肾病患者的代谢特点,通过研究营养物质在体内的吸收和代谢途径以及摄入比例,改进组分优化配比,有针对性的进行营养干预,延缓了肾脏病变的进行性加重,维持肾病患者体内钙磷代谢的平衡,降低患者营养不良的发生风险,改善患者的预后。3)该营养组合物符合肠内营养需求,有利于改善慢性肾病患者钙磷代谢障碍。4)该营养组合物符合患者饮食习惯,有利于改善慢性肾病患者负氮平衡状态。5)该营养组合物在抑制食物中磷吸收的同时,也能够改善慢性肾病患者缺铁引起贫血等问题。
本发明的描述是为了示例和描述起见而给出的,而并不是无遗漏的或者将本发明限于所公开的形式。很多修改和变化对于本领域的普通技术人员而言是显然的。选择和描述实施例是为了更好说明本发明的原理和实际应用,并且使本领域的普通技术人员能够理解本发明从而设计适于特定用途的带有各种修改的各种实施例。
Claims (5)
1.一种改善肾病患者钙磷代谢的营养组合物,其特征在于,按照重量份数计,包括:烟酸1.00~4.95重量份;硫胺素6.70~16.00重量份;有机酸铁盐10~20重量份;含钙营养强化剂15~30重量份;以及辅料35~65重量份;其中,所述含钙营养强化剂为β-羟基-β-甲基丁酸钙。
2.根据权利要求1所述的改善肾病患者钙磷代谢的营养组合物,其特征在于,所述有机酸铁盐选自甘氨酸亚铁、富马酸亚铁、柠檬酸亚铁、琥珀酸亚铁的一种。
3.根据权利要求2所述的改善肾病患者钙磷代谢的营养组合物,其特征在于,所述有机酸铁盐为甘氨酸亚铁或柠檬酸亚铁。
4.根据权利要求1所述的改善肾病患者钙磷代谢的营养组合物,其特征在于,所述辅料为麦芽糊精、抗性糊精、聚葡萄糖、玉米淀粉、蔗糖、葡萄糖中的一种。
5.一种根据权利要求1-4任一项所述的改善肾病患者钙磷代谢的营养组合物的应用,其特征在于,将所述营养组合物制备成粉剂、片剂或液体制剂,应用到配方食品中。
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