CN1365284A - 用于预防或治疗尿草酸盐过多的膳食或药物组合物 - Google Patents
用于预防或治疗尿草酸盐过多的膳食或药物组合物 Download PDFInfo
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Abstract
本发明描述了一种可以根据使用者的需要制成膳食或药物组合物的组合物,它包括下列细菌中的至少一种菌株:嗜热链球菌、短小乳芽孢杆菌、嗜酸乳芽孢杆菌、植物乳芽孢杆菌、婴儿双歧杆菌、长双歧杆菌和短双歧杆菌;该组合物适合于预防和/或治疗尿草酸盐过多和与此相关的疾病。
Description
本发明涉及下面指定的细菌种类和/或菌株在制备用于预防和/或治疗尿草酸盐过多和与此相关的疾病的组合物中的用途以及由此获得的组合物。
所述的组合物可以相应地呈现膳食组合物或食品增补剂或实际药物的形式并发挥其活性，这取决于所述组合物根据所施用于的特定个体而发挥的支持或预防或确切的治疗作用。这种预防或确切的治疗作用可以来源于所述细菌在处于尿草酸盐过多或由此相关疾病的危害中的受治疗者的肠道中的定居。
尿草酸盐过多由尿中存在的过量草酸盐构成(尿草酸盐＞40mg/天)。除由通过形成草酸盐而非甘氨酸改变乙醛酸代谢的遗传缺陷所导致外，它还可以是过量摄取诸如菠菜、可可、榛子、胡椒和茶这样富含草酸盐的食物或例如治疗用减肥药(例如ORLISTAT)的副作用。因此，提供能够减少或调节尿中存在的草酸盐的膳食增补剂是有用的。
尿草酸盐过多是形成肾结石的主要危害因素且它可以由从结肠中过量吸收草酸盐所导致或由因作为初期尿草酸盐过多(PH)的尿草酸盐过多而产生的肾脏负荷过重所导致。
草酸盐的尿含量看起来可构成就形成草酸钙结石而言的决定性征兆，甚至在具有正常钙的尿排泄的患者中也是如此，且草酸钙结石有时也可以在严格少尿透析中的患者体内形成，而在此范围内，由于先前没有肾石病史，所以甚至在最少量的尿中也可以存在草酸盐的过饱和。
每日排泄的草酸盐与尿的体积、摄取的维生素C、体重指标相关而与钙的摄取无关。
由Sutton和Walker对患有轻度尿草酸盐过多的自发性草酸钙结石形成者人群的研究没有能够证明肾脏对草酸盐的控制的任何显著改变且推断因可能的吸收过多机理而存在膳食中草酸盐负担增加。
在非-PH尿草酸盐过多患者中，对肠道草酸盐吸收过多由此必须给予最大的关注，它可提高肠道尿草酸盐过多的临床影象且通常促使复发产生肾结石。自1968年以来实际上已经认识到肾石病是一种疾病或肠切除术的并发症。
称作肠尿草酸盐过多(EHO)的肠草酸盐吸收增加取决于至少两种机理。第一种与发病或切除的回肠中胆盐的吸收障碍有关，它可导致胆盐缺乏和脂肪吸收障碍。饮食中的大部分草酸盐与钙结合且几乎不吸收，而难以吸收的脂肪与腔内的钙结合，从而减少了与草酸盐结合的量并使得草酸盐的吸收增加。EHO的第二种机理与结肠对由难以吸收的脂肪酸和胆盐产生的草酸盐的透性增加相关，它可能因腔内钙减少导致的上皮咬合连接变化而加重。这种尿草酸盐过多与脂肪痢的程度有关而通常与回肠切除＜30cm无关。代谢结肠草酸盐的细菌(产甲酸草酸杆菌)的计数减少及其受到难以吸收的胆盐的抑制同样可以形成EHO。最终，通过长期的非肠道营养作用可以观察到尿草酸盐过多，此外在结肠切除术和通过口腔途径吸收最少的患者中也能够观察到这种情况，这可能是由于内源性草酸盐合成增加所导致的。
草酸盐难溶于水，但尿可以通过存在的结晶化抑制剂而变得过饱和。尿的体积减少与这些抑制剂的含量降低结合起来的尿草酸盐过多易患肾结石。
草酸盐的肾实质沉积可以导致间质性肾炎和肾钙质沉着，其中带有急性或慢性肾功能不全。
对患有草酸钙结石的患者的治疗是复杂的且如下所述。
步骤1
因尿量排泄3l/天而增加摄取液体；
低草酸盐饮食(避免食用菠菜、大黄、甜菜、榛子、茶、可乐豆、巧克力、麸皮、草莓)；
低脂肪饮食(50g/天)；
补充钙(1-2g/天)；
消胆胺(4g、每天4次)；
步骤2(尽管进行了步骤1的治疗，但是如果结石复发)
碱化尿并补充柠檬酸盐(例如柠檬酸钾、柠檬酸钠＝30mEq碱、每天4次)；
补充镁(以校正尿的浓度)；
别嘌醇300mg/天(如果结石中含有尿酸)。
自从1955年以来已经从有关通过牛瘤胃的内含物和随后的其它草食动物大肠混合细菌菌群破坏草酸盐的文献中了解了对草酸盐进行胃肠道生物操作的可能性。
Allison在1985年涉及了定居在人体和其它动物大肠的产甲酸草酸杆菌的草酸盐的降解特异性作用。
近来在体外通过迟缓真杆菌WIH-1证实了食品中含有的草酸盐的降解作用。
随后，提示缺乏产甲酸草酸杆菌是囊性纤维化患者尿草酸盐过多的危害因素。
肠尿草酸盐过多由此是通过粘膜透性增加或诸如当饮食中钙含量降低时粪便草酸盐的溶解性和生物利用度增加而导致肠过量吸收草酸盐的结果。缺乏产甲酸草酸杆菌可能添加了一个新的病理生理学机制，从治疗观点来说，这种机制是重要的。
目前已经令人意外地发现下列细菌能够在有草酸盐存在的情况下生长和/或降解草酸盐：嗜热链球菌、短小乳芽孢杆菌、嗜酸乳芽孢杆菌、植物乳芽孢杆菌、婴儿双歧杆菌、长双歧杆菌和短双歧杆菌。
因此，本发明提供了下列细菌中的至少一种菌株在制备用于预防和/或治疗尿草酸盐过多和与此相关的疾病的膳食和/或药物组合物中的用途：嗜热链球菌、短小乳芽孢杆菌、嗜酸乳芽孢杆菌、植物乳芽孢杆菌、婴儿双歧杆菌、长双歧杆菌和短双歧杆菌。
优选短小乳芽孢杆菌的菌株是按照布达佩斯条约的规定于1998年2月6日寄存在德国Braunschweig的DSM-Deutsche Sammlungvon Mikroorganismen und Zellkulturen GmbH并给予其DSM 11988的保藏号的短小乳芽孢杆菌CD2的菌株或其突变体和衍生物。
更具体地说，尿草酸盐过多和与此相关的疾病包括肠尿草酸盐过多、肾草酸钙结石、因肠炎疾病导致的尿草酸盐过多、肾功能不全、膀胱结石、因尿草酸盐过多导致的心脏病、囊性纤维化和vulvodynia。
本发明的用途包括在兽医领域中的应用。
按照本发明，膳食和/或药物组合物能够与所述细菌一起定居在处于尿草酸盐过多或因尿草酸盐过多导致的疾病或因草酸钙结石病导致的疾病的危害中的受治疗者的肠中。
本发明同样提供了一种膳食或药物组合物，它包括下列细菌中的至少一种菌株：嗜热链球菌、短小乳芽孢杆菌、嗜酸乳芽孢杆菌、植物乳芽孢杆菌、婴儿双歧杆菌、长双歧杆菌和短双歧杆菌。
根据本发明的一个实施方案，将嗜热链球菌的菌株与选自短小乳芽孢杆菌、嗜酸乳芽孢杆菌和植物乳芽孢杆菌或其混合物组成的组的乳芽孢杆菌属的菌株混合。优选短小乳芽孢杆菌的菌株是按照布达佩斯条约的规定于1998年2月6日寄存在德国Braunschweig的DSM-Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH并给予其DSM 11988的保藏号的短小乳芽孢杆菌CD2的菌株或其突变体和衍生物。
根据本发明的另一个实施方案，将嗜热链球菌的菌株与选自婴儿双歧杆菌、长双歧杆菌和短双歧杆菌或其混合物组成的组的双歧杆菌属的菌株混合。在这种情况中，优选在所述的混合物中婴儿双歧杆菌、长双歧杆菌和短双歧杆菌的浓度之间的比例为1∶1∶1，用CFU/g组合物表示。
根据一个优选的实施方案，嗜热链球菌的浓度与乳芽孢杆菌属细菌的浓度之间的比例为1000∶1-1∶1000，用CFU/g组合物表示；而嗜热链球菌的浓度与双歧杆菌属细菌的浓度或双歧杆菌属细菌混合物的浓度之间的比例为1000∶1-1∶1000，用CFU/g组合物表示。
所述细菌的总浓度优选为106-1012CFU/g组合物。
根据本发明，该组合物可以另外含有下列物质或与下列物质一起给药：
-能够结合肠腔内草酸盐的物质，特别是消胆胺(例如0.5-4g/天)和海生来源的有机水胶体；
-维生素，特别是B6(例如20-200mg/天)和C(例如0.1-2mg/天)；
-氧化镁(例如50-600mg/天)；
-钙(例如0.5-2mg/天)；
-别嘌醇(例如50-300mg/天)；
-酶、乳酸菌、激素和利尿药、免疫调制剂、抗癌药、脂质、尿碱化剂、尿酸化剂、饱和和不饱和脂肪酸以及磷脂；
-引起作为副作用的尿草酸盐过多的药物，例如减肥药(例如ORLISTAT)。
一般可以以口服方式或通过腔内途径或通过灌肠法或通过灌肠给予颗粒、片剂、胶囊、栓剂形式的该组合物。
本发明还提供了一种基于巧克力、可可、芦笋、番茄、饮料/液体、菠菜、核桃、榛子、纤维、谷类、马铃薯、茶和花生酱的食品，它含有一定量的选自下列细菌中的至少一种菌株：嗜热链球菌、短小乳芽孢杆菌、嗜酸乳芽孢杆菌、植物乳芽孢杆菌、婴儿双歧杆菌、长双歧杆菌和短双歧杆菌；这些细菌菌株足以定居在处于尿草酸盐过多或因尿草酸盐过多导致的疾病的危害中的受治疗者的肠内。
最后，本发明提供了一种用于预防和/或治疗尿草酸盐过多和与此相关的疾病的方法，该方法通过对处于尿草酸盐过多或因尿草酸盐过多导致的疾病的危害中的受治疗者给予0.5-4g/天的权利要求4-10中任意一项的组合物来进行。
本文上下文中的“受治疗者”一般包括人和动物且特别是牧场动物、竞技动物和宠物。
实施例1
纯培养物
将婴儿双歧杆菌、嗜酸乳芽孢杆菌、植物乳芽孢杆菌、短小乳芽孢杆菌和嗜热链球菌用于下面的实验。
将全部菌株以冻干方式储存在冷冻环境中。将婴儿双歧杆菌接种在MRS肉汤(DIFCO)+0.5％葡萄糖中、在37℃下含有CO2和H2气体的GasPak厌氧罐内以厌氧方式培养18小时；将嗜酸乳芽孢杆菌和植物乳芽孢杆菌接种在MRS肉汤(DIFCO)中、在37℃下培养18小时；在30℃下将短小乳芽孢杆菌接种并在MRS(DIFCO)肉汤中培养18小时；而将嗜热链球菌接种在M17(DIFCO)肉汤+0.5％乳糖中培养并在37℃下培养18小时。
培养基
为了制备含有10mM和20mM草酸铵(BDH)的培养基，向10ml基质培养基(如下配制：10g
蛋白胨3号(DIFCO)+5g酵母提取物(DIFCO)+1ml Tween’80(DIFCO)+2g KH2PO4(BDH)+5g乙酸钠(BDH)+0.2g二氢柠檬酸盐(MERCK)+0.05g MgSO4·7H2O(MERCK)+0.05g MnSO4(MERCK)+适量水至500ml并在121℃下灭菌15分钟)中加入用0.45pm滤器灭菌的10ml下列糖类和草酸铵溶液，即：
就嗜酸乳芽孢杆菌、植物乳芽孢杆茵和短小乳芽孢杆菌而言：
1A：20mM草酸铵+40g/l葡萄糖(BDH)
1B：40mM草酸铵+40g/l葡萄糖
就嗜热链球菌而言：
2A：20mM草酸铵+40g/l葡萄糖(BDH)+10g/l乳糖(DIFCO)
2B：40mM草酸铵+40g/l葡萄糖+10g/l乳糖
就婴儿双歧杆菌而言：
3A：20mM草酸铵+50g/l葡萄糖
3B：40mM草酸铵+50g/l葡萄糖
在混合后，标记为A的样品含有10mM草酸铵；而标记为B的样品含有20mM草酸铵。
然后给新鲜的培养基接种10％的培养肉汤且在上述各菌株的适宜条件下对其进行培养。
使各生长的肉汤培养物进行在适宜条件下的培养基中含有的微生物数量的计数且特别是：
-在37℃下以厌氧方式将婴儿双歧杆菌在琼脂HHD(HI MediaLaboratories)中培养3天；
-在37℃下以厌氧方式将嗜酸乳芽孢杆菌在琼脂MRS(DIFCO)中培养3天；
-在37℃下以厌氧方式将植物乳芽孢杆菌和短小乳芽孢杆菌在琼脂MRS(DIFCO)中培养3天；
-在37℃下以厌氧方式将嗜热链球菌在琼脂MI7(DIFCO)中培养2天。
草酸的测定
样品制备
在90℃下将肉汤培养物进行巴氏消毒15分钟、然后以5000rpm离心10分钟且最终将上清液用0.45μm的滤器过滤。
方法
用对这种酸具有特异性的“草酸”试剂盒(Boehringer Mannheim)测定草酸含量。使用分光光度计(Perkin Elmer-λ5)在340nm处进行分析。
结果
正如可以从下面的表1中观察到的，所有菌株一般在有10mM草酸铵存在的情况下生长，而20mM的浓度部分抑制了微生物的生长，尤其是就嗜酸乳芽孢杆菌和嗜热链球菌而言更是如此。
然而，看起来在细菌生长与草酸盐降解之间没有相关性。因此，尽管植物乳芽孢杆菌和短小乳芽孢杆菌显示出显著生长，但是它们决不会降解草酸盐。
另一方面，尽管在有20mM草酸铵存在的情况下生长减少，但是嗜酸乳芽孢杆菌和嗜热链球菌降解两种浓度的草酸盐。最终，婴儿双歧杆菌显示出极为良好的降解活性且不会受到两种浓度之一的草酸盐的抑制。
表1
| 草酸 | 10mM | 20mM | ||||
| 降解(％) | 微生物含量(CFU/ml×106) | 降解(％) | 微生物含量(CFU/ml×106) | |||
| t0 | 最终生长 | t0 | 最终生长 | |||
| 短小乳芽孢杆菌 | 0.94 | 27 | 130 | 0.73 | 27 | 120 |
| 嗜酸乳芽孢杆菌 | 11.79 | 25 | 130 | 3.41 | 25 | 52 |
| 植物乳芽孢杆菌 | 1.42 | 32 | 270 | 0.00 | 32 | 230 |
| 嗜热链球菌 | 2.31 | 2.5 | 28 | 3.06 | 2.5 | 9 |
| 婴儿双歧杆菌 | 5.26 | 36 | 300 | 2.18 | 36 | 230 |
实施例2
病例
在得到许可后，以口服方式对患有尿草酸盐过多的7位患者给予6g/天的嗜热链球菌、持续3周；并且在24小时内的0时和3周后测定草酸尿。
通过用于临床化学的标准方法测定尿中的草酸盐并表示为24小时时间期限内收集的尿中草酸盐的mg数。
3周后，草酸盐血结果如下：
患者 前 后
1 50 7
2 47 30
3 41 31
4 95 56
5 62 14
6 58 34
7 49 12
显然在尿中含有高浓度草酸盐的患者中，本治疗方法使草酸盐的浓度显著降低。
Claims (14)
1.下列细菌中的至少一种菌株在制备用于预防和/或治疗尿草酸盐过多和与此相关的疾病的膳食和/或药物组合物中的用途：嗜热链球菌、短小乳芽孢杆菌、嗜酸乳芽孢杆菌、植物乳芽孢杆菌、婴儿双歧杆菌、长双歧杆菌和短双歧杆菌。
2.根据权利要求1的用途：其中短小乳芽孢杆菌的菌株是按照布达佩斯条约的规定于1998年2月6日寄存在德国Braunschweig的DSM-Deutsche Sammlung von Mikroorganismen und ZellkulturenGmbH并给予其DSM 11988的保藏号的短小乳芽孢杆菌CD2的菌株或其突变体和衍生物。
3.根据权利要求1或2的用途，其中尿草酸盐过多和与此相关的疾病包括肠尿草酸盐过多、肾草酸钙结石、因肠炎疾病导致的尿草酸盐过多、肾功能不全、膀胱结石、因尿草酸盐过多导致的心脏病、囊性纤维化和vulvodynia。
4.根据权利要求1、2或3的用途，其中所述的膳食和/或药物组合物能够与所述细菌一起定居在处于尿草酸盐过多或因尿草酸盐过多导致的疾病或因肾草酸钙结石导致的疾病的危害中的受治疗者的肠内。
5.根据上述权利要求中任意一项的用途，应用于兽医领域。
6.包括下列细菌中至少一种菌株的膳食或药物组合物：嗜热链球菌、短小乳芽孢杆菌、嗜酸乳芽孢杆菌、植物乳芽孢杆菌、婴儿双歧杆菌、长双歧杆菌和短双歧杆菌。
7.根据权利要求6的组合物，其中将嗜热链球菌的菌株与选自短小乳芽孢杆菌、嗜酸乳芽孢杆菌和植物乳芽孢杆菌或其混合物组成的组的乳芽孢杆菌属的菌株混合。
8.根据权利要求7的组合物，其中短小乳芽孢杆菌的菌株是按照布达佩斯条约的规定于1998年2月6日寄存在德国Braunschweig的DSM-Deutsche Sammlung von Mikroorganismen und ZellkulturenGmbH并给予其DSM 11988的保藏号的短小乳芽孢杆菌CD2的菌株或其突变体和衍生物。
9.根据权利要求6的组合物，其中将嗜热链球菌的菌株与选自婴儿双歧杆菌、长双歧杆菌和短双歧杆菌或其混合物组成的组的双歧杆菌属的菌株混合。
10.根据权利要求9的组合物，其中在所述的混合物中婴儿双歧杆菌、长双歧杆菌和短双歧杆菌的浓度之间的比例为1∶1∶1，用CFU/g组合物表示。
11.根据权利要求7或8的组合物，其中嗜热链球菌的浓度与乳芽孢杆菌属细菌的浓度之间的比例为1000∶1-1∶1000，用CFU/g组合物表示。
12.根据权利要求9或10的组合物，其中嗜热链球菌的浓度与双歧杆菌属细菌的浓度或双歧杆菌属细菌混合物的浓度之间的比例为1000∶1-1∶1000，用CFU/g组合物表示。
13.根据权利要求6-12中任意一项的组合物，其中所述细菌的浓度为106-1012CFU/g组合物。
14.根据权利要求6-13中任意一项的组合物，它还含有下列物质或与下列物质一起给药：
-能够结合肠腔内草酸盐的物质，特别是消胆胺(例如0.5-4g/天)和海生来源的有机水胶体；
-维生素，特别是B6(例如20-200mg/天)和C(例如0.1-2mg/天)；
-氧化镁(例如50-600mg/天)；
-钙(例如0.5-2mg/天)；
-别嘌醇(例如50-300mg/天)；
-酶、乳酸菌、激素和利尿药、免疫调制剂、抗癌药、脂质、尿碱化剂、尿酸化剂、饱和和不饱和脂肪酸以及磷脂；
-引起作为副作用的尿草酸盐过多的药物，例如减肥药(例如ORLISTAT)。
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| Application Number | Priority Date | Filing Date | Title |
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| IT1999RM000338A IT1309427B1 (it) | 1999-05-28 | 1999-05-28 | Composizione dietetica o farmaceutica utile per la prevenzione o iltrattamento dell'iperossaluria e suo uso |
| ITRM99A000338 | 1999-05-28 |
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| EP (1) | EP1181027B1 (zh) |
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| CN101606952B (zh) * | 2008-06-17 | 2012-09-19 | 上海交通大学医学院附属第三人民医院 | 乳双歧杆菌在制备预防泌尿系统结石药物中的应用 |
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| RU2139346C1 (ru) * | 1999-03-02 | 1999-10-10 | Шендеров Борис Аркадьевич | Штамм бактерий lactobacillus plantarum, обладающий способностью снижать уровень оксалата и используемый для приготовления препаратов и продуктов питания для профилактики и лечения гипероксалурии |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101606952B (zh) * | 2008-06-17 | 2012-09-19 | 上海交通大学医学院附属第三人民医院 | 乳双歧杆菌在制备预防泌尿系统结石药物中的应用 |
| WO2010105491A1 (zh) * | 2009-03-16 | 2010-09-23 | Wang Zhaohe | 含在植物纤维或微生物不溶组分中的草酸降解酶的制备方法及用途 |
| CN113454229A (zh) * | 2018-12-10 | 2021-09-28 | 诺沃梅生物技术股份有限公司 | 用于治疗高草酸尿症的方法和组合物 |
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