CN112007052A - 护肾益生菌组合物 - Google Patents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/66—Microorganisms or materials therefrom
- A61K35/74—Bacteria
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- A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
- A61K35/747—Lactobacilli, e.g. L. acidophilus or L. brevis
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- A—HUMAN NECESSITIES
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- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/125—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives containing carbohydrate syrups; containing sugars; containing sugar alcohols; containing starch hydrolysates
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- A23L33/135—Bacteria or derivatives thereof, e.g. probiotics
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- A61K35/66—Microorganisms or materials therefrom
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- A61P13/12—Drugs for disorders of the urinary system of the kidneys
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- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
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Abstract
本发明公开了护肾益生菌组合物,属于益生菌的所有相关食品产业领域。它包括嗜酸乳杆菌、长双歧杆菌、两歧双歧杆菌和低聚木糖粉。本发明中护肾益生菌组合物组合物是一种益生菌和益生元的组合物,能有效调节血压,减缓肾脏阻塞。同时增加短链脂肪酸的产量,降低血尿素氮,血清肌酐和尿白蛋白的水平,改善肾纤维化的状况,抑制肾脏的炎症反应,进一步减轻肾脏疾病的进程。通过益生菌和益生元的组合,可以帮助人体调节肠道菌群,是一种能长期安全服用的,有效改善慢性肾病之食品补充或药物。
Description
技术领域
本发明涉及护肾益生菌组合物,属于益生菌的所有相关食品产业领域。
背景技术
慢性肾病(Chronic kidney disease,CKD)影响着全球约10%的人口,仅在美国每年就造成约480亿美元的经济影响(Jha V,2013)。高血压是CKD的一个重要危险因素,大约85% - 90%的CKD 3期患者有高血压(Rao M V,2008)。长期高血压导致高的肾小球内压,进而损害肾小球的过滤(Taler S J,2013)。因此,降低血压是减慢CKD进展的一种重要且广泛使用的方法。目前CKD早期的治疗主要集中在控制血压、减少蛋白质和盐的摄入、预防急性肾损伤和血糖控制(Inker L A,2014)。CKD没有治愈方法或预防策略,由于在疾病的早期阶段缺乏症状,及时治疗是极具挑战性的(Andrassy K M,2012)。此外,除了透析和肾移植外,对终末期肾病(ESRD)缺乏有效的治疗方法。因此,需要改变模式的概念和创新方法来发现、管理、控制和最终治愈这些疾病。
越来越多的证据表明,肠道菌群在高血压和CKD的发展中发挥着重要作用。肠道菌群不断地与寄主的重要器官系统,如大脑、骨髓、血管系统、肾脏、免疫系统和自主神经系统(autonomic nervous system,ANS)进行通讯(Evenepoel P,2017;Bravo J A,2011)。这种肠道与肾脏之间的通讯通过代谢依赖性和免疫两种路径构成“肠-肾轴”,对肾脏疾病起到基础性作用。骨髓来源的免疫细胞被肠道菌群激活,导致通过循环影响大脑、ANS和肾脏的低级别炎症。周围刺激会影响ANS,进而改变进入肾、肠和淋巴器官的神经输入。此外,免疫和肠道菌群衍生产品影响肾功能,导致CKD的产生(Cigarran Guldris S,2017)。当肠道菌群失调时,产生过量的尿毒症毒素(如硫酸吲哚酚、p-甲苯基硫酸、N-氧化三甲胺等)、较少的肾脏保护性代谢产物;损害肾脏的代谢产物参与氧化应激、炎症、尿毒症、肾功能恶化、肾脏疾病等活动,伴随着较高的心血管风险与CKD患者的死亡率(Mahmoodpoor F,2017)。肠道生态失调在许多慢性疾病中具有重要的作用,改善肠道生态失调可能是预防和管理这些疾病的潜在策略。
体外活菌体抗氧化实验证实,长双歧杆菌Bifiodbacterium longum BLI-02有媲美维生素C的抗氧化能力,能够清除自由基,避免对机体的氧化伤害。嗜酸乳杆菌Lactobacillus acidophilus TYCA06、长双歧杆菌BLI-02和两歧双歧杆菌Bifidobacterium bifidium VDD088的复合菌能有效降低CKD小鼠的舒张压和收缩压水平,通过调节血压减缓肾脏阻塞。该益生菌组合物以降低血尿素氮(BUN),血清肌酐(CRE)和尿白蛋白,改善肾纤维化的状况,抑制肾脏的炎症反应,进一步减轻肾脏疾病的进程(Hsieh PS,2019)。
在CKD患者的胃肠道中,以含有脲酶、尿酸酶、吲哚和甲酚形成酶的细菌为主,而产生短链脂肪酸(SCFAs)的细菌数量减少。短链脂肪酸是膳食纤维的细菌发酵产物,有报道称其可改善肾损伤(Pluznick J,2016)。此外,流行病学证据表明,摄入高膳食纤维与CKD和炎症的风险降低有关(Ma J,2016)。然而,目前人均的纤维摄入量仅为推荐摄入量的一半,因此,膳食纤维补充剂可能会显著改善CKD患者的健康。低聚木糖(xylooligosaccharide,XOS)是一种益生元纤维,由2-7个木糖单体组成。在人类和小鼠研究中,相对低剂量的XOS膳食补充剂可以改善血糖控制,降低促炎细胞因子,增加粪便双歧杆菌的相对比例(Yang J,2015)。研究表明,饮食中添加XOS的CKD小鼠模型中,小鼠体内9个富集的菌群,其中有6个都显著降低。另外XOS能增加短链脂肪酸的产量,降低尿素氮水平。低聚木糖XOS纤维对慢性肾病的缓解作用,很可能通过影响肠道菌群结构和代谢达到。该研究是通过菌群干预影响宿主机体状态的又一例证,对于研究肠道菌群-宿主互作、益生元功效等都具有参考价值(Yang J,2018)。
慢性肾病CKD影响着全球约10%的人口,高血压是CKD的一个重要危险因素,目前CKD早期的治疗主要集中在控制血压、减少蛋白质和盐的摄入、预防急性肾损伤和血糖控制。CKD没有治愈方法或预防策略,由于在疾病的早期阶段缺乏症状,及时治疗是极具挑战性的。此外,除了透析和肾移植外,对终末期肾病(ESRD)缺乏有效的治疗方法。因此,需要改变模式的概念和创新方法来发现、管理、控制和最终治愈这些疾病。通过益生菌和益生元的组合物,能有效调节血压,减缓肾脏阻塞。同时增加短链脂肪酸的产量,降低血尿素氮,血清肌酐和尿白蛋白的水平,改善肾纤维化的状况,抑制肾脏的炎症反应,进一步减轻肾脏疾病的进程。通过益生菌和益生元的组合,可以帮助人体调节肠道菌群,有效改善慢性肾病。
发明内容
本发明所要解决的技术问题在于:提供护肾益生菌组合物,作为有效、安全改善慢性肾病的食品补充或药物的方法,为护肾市场提供一种全新的方案。
本发明所要解决的技术问题采取以下技术方案来实现:
护肾益生菌组合物,包括嗜酸乳杆菌、长双歧杆菌、两歧双歧杆菌和低聚木糖粉,有效量为每日合并补充150亿~600亿嗜酸乳杆菌、长双歧杆菌和两歧双歧杆菌,即0.5*1010cfu/day~2.0*1010 cfu/day的嗜酸乳杆菌菌量,0.5*1010 cfu/day~2.0*1010 cfu/day的长双歧杆菌菌量和0.5*1010 cfu/day~2.0*1010 cfu/day的两歧双歧杆菌菌量,每日0.5克~2.0克低聚木糖粉。
作为优选实例,所述嗜酸乳杆菌为嗜酸乳杆菌TYCA06、长双歧杆菌为长双歧杆菌BLI-02、两歧双歧杆菌为两歧双歧杆菌VDD088。
作为优选实例,所述嗜酸乳杆菌、长双歧杆菌、两歧双歧杆菌合并低聚木糖粉的有效量为每日补充150亿,即0.5*1010 cfu/day的嗜酸乳杆菌、0.5*1010 cfu/day的长双歧杆菌和0.5*1010 cfu/day的两歧双歧杆菌菌量以及每日2.0克低聚木糖粉。
作为优选实例,所述嗜酸乳杆菌、长双歧杆菌、两歧双歧杆菌合并低聚木糖粉可进一步包括药学上可接受之载剂、赋形剂或稀释剂;并可进一步制成流体乳品、浓缩牛奶、优酪乳、酸乳、冷冻优格、乳杆菌发酵饮料、奶粉、冰淇淋、乳酪、干酪、豆浆、发酵豆浆、蔬果汁、果汁、运动饮料、甜点、果冻、糖果、婴儿食品、健康食品、动物饲料、中草药组合物或膳食补充品。
本发明的有益效果是:本发明中的嗜酸乳杆菌、长双歧杆菌、两歧双歧杆菌合并低聚木糖粉,通过益生菌和益生元的组合物,能有效调节血压,减缓肾脏阻塞,同时增加短链脂肪酸的产量,降低血尿素氮,血清肌酐和尿白蛋白的水平,改善肾纤维化的状况,抑制肾脏的炎症反应,进一步减轻肾脏疾病的进程,通过益生菌和益生元的组合,可以帮助人体调节肠道菌群,有效改善慢性肾病。
具体实施方式
为了对本发明的技术手段、创作特征、达成目的与功效易于明白了解,下面结合具体实施例,进一步阐述本发明。
实施例一
护肾益生菌组合物,包括嗜酸乳杆菌、长双歧杆菌、两歧双歧杆菌合并低聚木糖粉,所述嗜酸乳杆菌、长双歧杆菌、两歧双歧杆菌合并低聚木糖粉的有效量为每日补充150亿,即0.5*1010 cfu/day的嗜酸乳杆菌、0.5*1010 cfu/day的长双歧杆菌和0.5*1010 cfu/day的两歧双歧杆菌菌量以及每日0.5克低聚木糖粉。
实施例二
护肾益生菌组合物,包括嗜酸乳杆菌、长双歧杆菌、两歧双歧杆菌合并低聚木糖粉,所述嗜酸乳杆菌、长双歧杆菌、两歧双歧杆菌合并低聚木糖粉的有效量为每日补充300亿,即1.0*1010 cfu/day的嗜酸乳杆菌、1.0*1010 cfu/day的长双歧杆菌和1.0*1010 cfu/day的两歧双歧杆菌菌量以及每日1.0克低聚木糖粉。
实施例三
护肾益生菌组合物,包括嗜酸乳杆菌、长双歧杆菌、两歧双歧杆菌合并低聚木糖粉,所述嗜酸乳杆菌、长双歧杆菌、两歧双歧杆菌合并低聚木糖粉的有效量为每日补充450亿,即1.5*1010 cfu/day的嗜酸乳杆菌、1.5*1010 cfu/day的长双歧杆菌和1.5*1010 cfu/day的两歧双歧杆菌菌量以及每日1.5克低聚木糖粉。
实施例四
护肾益生菌组合物,包括嗜酸乳杆菌、长双歧杆菌、两歧双歧杆菌合并低聚木糖粉,所述嗜酸乳杆菌、长双歧杆菌、两歧双歧杆菌合并低聚木糖粉的有效量为每日补充600亿,即2.0*1010 cfu/day的嗜酸乳杆菌、2.0*1010 cfu/day的长双歧杆菌和2.0*1010 cfu/day的两歧双歧杆菌菌量以及每日2.0克低聚木糖粉。
研究方法及进行步骤
1. 临床试验
选取40名年龄在18-60岁的患有慢性肾病患者,男女不限,试验组按照上述四个实施例随机分为4组(每组10例),试验组试用本产品六个月,然后断药再持续观察六个月,试用期间不使用其它护肾的中西药物及疗法,追踪观察试验者服用本产品1天前、3个月后、6个月后、9个月后、12个月血清中肾丝球过滤速率(eGFR),以判断其肾病改善情况。
疗效判断标准:
(1)显效: 服用本产品3个月后,相较于服用本产品1天前血清中肾丝球过滤速率有显著性改善; 6个月后相较3个月后有着更显著的改善;并在9个月后以及12月后没有显著恶化;
(2)(2)有效: 服用本产品3个月后和6个月后,相较于服用本产品1天前血清中肾丝球过滤速率都有显著性改善;9个月后,12个月后相较于3个月后和6个月后血清中肾丝球过滤速率显著恶化,但是仍然优于服用本产品前1天的水平;
(3)无效: 服用本产品3个月后和6个月后,相较于服用本产品1天前血清中肾丝球过滤速率无显著性差异;
按照以上改善慢性肾病疗效标准观察效果,结果表明,本发明的组合物能够显著改善慢性肾病患者血清中肾丝球过滤速率的水平,并持续安全有效。
以上显示和描述了本发明的基本原理和主要特征和本发明的优点。本行业的技术人员应该了解,本发明不受上述实施例的限制,在不脱离本发明精神和范围的前提下,本发明还会有各种变化和改进,这些变化和改进都落入要求保护的本发明范围内。本发明要求保护范围由所附的权利要求书及其等效物界定。
Claims (4)
1.护肾益生菌组合物,其特征在于:包括嗜酸乳杆菌、长双歧杆菌、两歧双歧杆菌和低聚木糖粉,有效量为每日合并补充150亿~600亿嗜酸乳杆菌、长双歧杆菌和两歧双歧杆菌,即0.5*1010 cfu/day~2.0*1010 cfu/day的嗜酸乳杆菌菌量,0.5*1010 cfu/day~2.0*1010cfu/day的长双歧杆菌菌量和0.5*1010 cfu/day~2.0*1010 cfu/day的两歧双歧杆菌菌量,每日0.5克~2.0克低聚木糖粉。
2.根据权利要求1所述的护肾益生菌组合物,其特征在于:所述嗜酸乳杆菌为嗜酸乳杆菌TYCA06、长双歧杆菌为长双歧杆菌BLI-02、两歧双歧杆菌为两歧双歧杆菌VDD088。
3.根据权利要求1所述的护肾益生菌组合物,其特征在于:嗜酸乳杆菌、长双歧杆菌、两歧双歧杆菌合并低聚木糖粉的有效量为每日补充150亿,即0.5*1010 cfu/day的嗜酸乳杆菌、0.5*1010 cfu/day的长双歧杆菌和0.5*1010 cfu/day的两歧双歧杆菌菌量以及每日2.0克低聚木糖粉。
4.根据权利要求1所述的护肾益生菌组合物,其特征在于:所述嗜酸乳杆菌、长双歧杆菌、两歧双歧杆菌合并低聚木糖粉可进一步包括药学上可接受之载剂、赋形剂或稀释剂;并可进一步制成流体乳品、浓缩牛奶、优酪乳、酸乳、冷冻优格、乳杆菌发酵饮料、奶粉、冰淇淋、乳酪、干酪、豆浆、发酵豆浆、蔬果汁、果汁、运动饮料、甜点、果冻、糖果、婴儿食品、健康食品、动物饲料、中草药组合物或膳食补充品。
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Application publication date: 20201201 |