CN113368138B - 益生菌用于预防和/或治疗高原病 - Google Patents
益生菌用于预防和/或治疗高原病 Download PDFInfo
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- CN113368138B CN113368138B CN202110677289.0A CN202110677289A CN113368138B CN 113368138 B CN113368138 B CN 113368138B CN 202110677289 A CN202110677289 A CN 202110677289A CN 113368138 B CN113368138 B CN 113368138B
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Abstract
本发明提供一种益生菌在制备预防和/或治疗高原病以及预防和/或改善高原病的症状的产品中的应用,所述的产品选自食品、保健品或药物。
Description
技术领域
本发明涉及生物医药技术领域,具体涉及益生菌在制备预防和/或治疗高原病的药物中的应用以及益生菌在制备预防和/或改善高原病的症状的产品中的应用。
背景技术
高原病是发生于高原低氧环境中的一种特发性疾病,其依据发病急缓分为急性慢性两大类,其临床上主要表现为各器官供氧减少引起运动耐量下降,包括头痛、头晕、气短、胸闷、腹胀、腹痛、乏力、关节痛、厌食、消瘦、记忆力减退、失眠、手足麻木或胀痛感等。患者容易引发凝血功能紊乱,出现鼻出血、牙龈出血、皮肤黏膜出血点或瘀斑等。慢性高原病引起血压增高、心脏功能减退、肺动脉高压等临床症状。如长时间得不到有效控制和改善,器官失代偿可引起高原性脑水肿、高原性肺水肿、高原性心脏病等疾病;持续性缺氧环境刺激也可以导致肺血管壁增厚、狭窄、肺血管重建,从而导致肺动脉高压,进而使右心后负荷增加、右心肥大,严重者发展为多脏器功能衰竭。
针对高原病的治疗方法有许多,但在不脱离高原环境的前提下慢性高原病(CMS)难以治愈。对于一些需要长期在高原环境工作或者居住的患者,治疗手段十分有限。在常用的治疗手段中,血液稀释疗法可以暂时降低患者红细胞和血红蛋白浓度,但会反弹;吸氧可以即时的缓解缺氧症状,但是需要高原地区患者在连续1年以上,每天至少进行1小时的低浓度(2L/min)的氧疗,才可缓慢修复慢性高原病的对身体的损伤,该方法成本高,见效慢;药物治疗方法中,硝苯地平作为一种钙拮抗剂的代表药物,其疗效确切,但不良反应多诸如,例如低血压、肺水肿、心肌梗死、充血性心力衰竭、心律失常、头晕、恶心、腹泻等等。乙酰唑胺可以兴奋呼吸中枢,增加肺通气量,从而增加氧分压、氧饱和度,但是停药后,体内的缺氧环境没有得到改善,长期服用乙酰唑胺会对神经系统造成影响。
因此,找到一种兼顾起效迅速、安全性高、成本低廉、副作用小的防治高原病的方法是十分有意义的。
益生菌是一种活的微生物,给予足够剂量益生菌对宿主健康有利,乳酸杆菌和双歧杆菌制剂(包括食物、药物和食品添加剂),是目前临床上最常用的益生菌制剂,研究表明,益生菌在改善代谢综合征、预防和治疗心血管疾病等方面具有确切效果,具体的,益生菌可有效降低高血压前期和轻度高血压患者收缩压和舒张压,有效预防心脑血管事件的发生,另外,益生菌具有直接的心脏保护作用,有利于改善心肌缺血损伤和心功能,与传统心血管疾病治疗药物相比,益生菌作用更加温和,副作用更小。但是,迄今为止,尚未发现益生菌在高原环境中作为治疗和预防高原心肺以及血管损伤的药物的用途的报道。
发明内容
针对现有技术中的存在的技术问题,本发明提供一种益生菌在制备预防或治疗高原病的药物中的应用。
本发明还提供一种益生菌在制备预防和/或改善高原病的症状的产品中的应用。
所述益生菌包括乳杆菌属和/或双歧杆菌属;
优选的,所述的产品选自食品、保健品或药物;
更优选的,所述的食品或保健品为非治疗目的的预防和/或改善高原病的症状。
所述乳杆菌属选自鼠李糖乳酸杆菌、德式乳杆菌保加利亚亚种、高加索酸奶乳酸杆菌、类高加索酸奶乳酸杆菌、短乳酸杆菌、干酪乳酸杆菌、胚芽乳酸杆菌、发酵乳酸杆菌、副干酪乳酸杆菌、嗜酸乳酸杆菌、类植物酸杆菌或瑞士乳杆菌中的一种或多种;
所述双歧杆菌选自长双歧杆菌、短双歧杆菌、双叉双歧杆菌、假链状双歧杆菌、链状双歧杆菌、假链状双歧杆菌中的一种或多种。
在本发明的具体实施方式中,所述乳酸杆菌属,选自德式乳杆菌保加利亚亚种和/或瑞士乳杆菌中的一种或多种。
本发明所述的高原病选自在高原环境下产生的急性高原病、慢性高原病。
优选的,所述的高原环境为海拔2000m以上,具有低压、缺氧条件。
进一步优选的,所述的高原环境为海拔3500m以上,具有低压、缺氧条件。
在本发明的具体实施方式中,所述的高原环境为海拔5500m以上,具有低压、缺氧条件。
所述的急性高原病选自高原昏迷、高原脑水肿、高原肺水肿或脑、肺异常症状同时存在的混合型疾病;
所述的慢性高原病选自高原心脏病、高原红细胞增多症、高原高血压、高原低血压、高原心脏病、红细胞增多症同时存在的混合型疾病。
具体的,所述的高原病为抗高原心肺及血管损伤;
具体的,所述高原病为高原心脏病;
在本发明的具体实施方式中,所述的高原心脏病包括肺动脉高压、右心室扩大、充血性右心衰竭、右心室肥厚或右心功能不全。
所述高原病的症状选自由高原病引起的头痛、头昏、恶心呕吐、心慌气短、胸闷胸痛、失眠、嗜睡、食欲减退、腹胀或手足发麻中的一种或多种。
所述高原病的症状选自由高原病引起的心慌、心率加快、疲倦、抽搐、意识恍惚、手足麻木、唇指发绀、颜面水肿、四肢水肿或认知能力骤降中的一种或两种以上的组合。
在本发明的一个具体实施方式中。所述的预防和/或治疗高原病症的益生菌可以有效降低因高原环境产生的平均肺动脉压(mPAP),即可以有效降低低压低氧环境造成的血管损伤;
在本发明的一个具体实施方式中。所述的预防和/或治疗高原病症的益生菌可以有效降低右心室肥厚指数(RV/(LV+OS));即可有效降低低压低氧环境造成的心肺功能损伤。
所述药物中包括预防和/或治疗高原病症的益生菌以及药学上可接受的辅料;
所述辅料选自载体、赋形剂、稀释剂、润滑剂、润湿剂、乳化剂、防腐剂、抗氧化剂、缓冲剂、等渗剂、悬浮剂、助悬剂、增溶剂、增稠剂、稳定剂、甜味剂以及香料中的一种或两种以上组合;
优选的,所述药学上可接受的辅料为选自乳糖、葡萄糖、蔗糖、山梨糖醇、甘露糖、淀粉、阿拉伯胶、磷酸钙、藻酸盐、明胶、硅酸钙、细结晶纤维素、纤维素、水、糖浆、甲基纤维素、羟基苯甲酸甲酯、羟基苯甲酸丙酯、滑石、硬脂酸镁和矿物油中的一种或两种以上的组合。
所述药物的制剂形式为肠道或者非肠道组合药的剂型;
所述肠道给药剂型包括片剂、颗粒剂、胶囊、溶液剂、乳剂、混悬剂、酏剂、糖浆剂、粉剂中的一种或多种;
所述非肠道给药剂型包括注射剂;
优选的,所述注射剂的注射途径包括静脉注射、肌内注射、皮下注射、皮内注射及腔内注射途径。
所述注射给药剂型包括水或非水的等渗注射液;
具体的,所述注射给药剂型包括抗氧化剂,缓冲剂、等渗剂、悬浮剂;
优选的,所述注射给药剂型包括助悬剂,增溶剂,增稠剂,稳定剂和防腐剂。
在本发明的实践中,药物可通过例如静脉输注,经口,局部,腹膜内,膀胱内和鞘内给药。化合物的制剂可存在于单位剂量或者多剂量密封容器诸如安瓿和小瓶中。注射用溶液和悬浮液可从先前所述类型的无菌粉剂、颗粒和片剂制备。
所述制剂优选为单位剂型。在这种形式中,该制剂被再分成包含适当的量的活性组分的单位剂量。单位剂型可以是包装好的制剂,该包装含有离散的量的制剂,诸如包装在小瓶或者安瓿瓶中的片剂、胶囊和粉剂。另外,单位剂型可以是胶囊,片剂或者其可以是在包装形式中的适当数目的任何这些剂型。
单位剂量制剂中活性组分的量可从0.1毫克到1000毫克之间改变或调整,根据活性组分的具体应用和效力而定。如果需要,药物还可包含其它适合的治疗剂。
可药用载体部分地根据给用的具体药物而定,并根据其具体给药方法而定。因此,本发明的药物存在各种适当的制剂。
在本发明的环境下,对对象剂量给用应当足够随着时间在对象体内产生有益的治疗学应答。剂量通过所用的具体化合物的效力和对象的病况、以及待治疗对象的体重或者体表面积而定。剂量的大小将根据在具体对象中伴随具体化合物给药产生的任何不利副作用的存在、性质和程度而定。在正被治疗的病症的治疗或者预防中确定待给药的化合物的有效量中,医师可以评价诸如化合物的循环血浆水平、化合物毒性和/或疾病进程等因素而定。
所述食品包括益生菌以及食品学上可接受的辅料。
本发明所述的食品的种类不受特别限制,可以为任何已知的食品,例如,奶制品、饼干、糕点、饮料、保健品等。
所述食品选自固体、乳品、溶液制品、粉末制品和悬浮液制品中的至少一种形式。
所述食品学上可接受的辅料选自载体、赋形剂、稀释剂、润滑剂、润湿剂、乳化剂、悬浮液稳定剂、防腐剂、甜味剂以及香料中的一种或两种以上的组合。
根据本发明的实施例,所述食品学上可接受的辅料选自乳糖、葡萄糖、蔗糖、山梨糖醇、甘露糖、淀粉、阿拉伯胶、磷酸钙、藻酸盐、明胶、硅酸钙、细结晶纤维素、纤维素、水、糖浆、甲基纤维素、羟基苯甲酸甲酯、羟基苯甲酸丙酯、滑石、硬脂酸镁和矿物油中的种以上的组合。
附图说明
图1是将大鼠在模拟5500米高原环境下饲养14天后,各组大鼠的肺动脉高压(mPAP)的变化。
图2是将大鼠在模拟5500米高原环境下饲养14天后,各组大鼠RV/(LV+OS)的变化。
具体实施方式
除非另有定义,本发明中所使用的所有科学和技术术语具有与本发明涉及技术领域的技术人员通常理解的相同的含义。
本发明中,术语“mPAP(Mean pulmonary artery pressure)”是指平均肺动脉压,具体为,一个循环周期(收缩期和舒张期)中,各时间点肺动脉压的平均值;
本发明中,术语“SD大鼠”为大鼠的一个品系。其毛色白化,主要特性为,头部狭长、尾长接近于身长,产仔多,生长发育较快。10周龄时雄性大鼠体重可达300~400g,雌性大鼠达180~270g;性情稍为凶猛;对疾病的抵抗力较强,尤其对呼吸道疾病的抵抗力很强;自发性肿瘤的发生率较低;对性激素敏感性高;广泛用于药理、毒理、药效及GLP实验。
本发明中,术语“DDW”,是指氘含量较低的低氘水,被称之为轻氢分子水,又称超轻水。”
本发明中,术语“RV/(LV+OS)”是指右心肥厚指数。
本发明所述的“和/或”包括择一列出的项目以及任何数量的项目组合。
本发明所述的“包括”是开放式的描述,含有所描述的指定成分或步骤,以及不会实质上影响的其他指定成分或步骤。
本发明所述的“治疗”表示在疾病已开始发展后减缓、中断、阻止、控制、停止、减轻、或逆转一种体征、症状、失调、病症、或疾病的进展或严重性,但不一定涉及所有疾病相关体征、症状、病症、或失调的完全消除。
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,所描述的实施例仅是本发明一部分实施例,而不是全部的实施例。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。
实施例
实施例1
1、益生菌对高原心脏病模型大鼠的影响
材料与方法:
1.1动物
SD大鼠40只(200g左右,雄性,清洁级),购自北京维通利华实验动物有限公司,许可证号:SCXK(京)2016-0006。低压氧舱饲养,定时给予全价营养饲料喂食,室温22-25℃,湿度30%-50%。
1.2试剂与样品
益生菌剂由山东中科嘉义生物工程有限公司合成,由上海生工生物工程(上海)股份有限公司鉴定。益生菌液由DDW配置。
1.3仪器
多因素复合环境模拟医学科学实验舱(型号DYC-3285,北京军事医学科学院仪器中心);小动物呼吸机(kent scientific,美国);多功能生理仪(Millar,美国);小动物超声(Visual Sonics Inc,加拿大)
1.4实验设计与过程
将40只大鼠随机分为4组,每组10只,其中3组置于实验舱中,调节舱内压力至380mmHg,模拟海拔5500米的高原环境,每天打开实验舱1小时,以便给动物添加饲料和水及给予相应的药物处理,同时保持大鼠所处的环境12:12小时昼夜交替,21天后分别灌胃给予溶剂、益生菌之德式乳杆菌保加利亚亚种(L.bulgaricus)和瑞士乳杆菌(L.helveticus)(2*1010CFU/只)每日一次并持续14天。第4组大鼠放在同一房间中常压常氧环境下饲养。
1.5指标检测方法
采用3%的戊巴比妥钠,0.2ml/100g腹腔注射麻醉大鼠,进行超声检测。之后将大鼠仰卧位固定于手术台上,气管切管,连接呼吸机,开胸,暴露心脏,导管插入右心室,行右心导管检查。处死大鼠,取出心脏,去除心房组织及附着脂肪,分离左右心室,滤纸吸干水分,分别称重。
1.6统计学方法
所有数据用x±s表示,采用单因素方差分析进行组间比较,P<0.05为差异有统计学意义,采用SPSS19.0软件包进行统计学处理。
2、实验结果
2.1对大鼠mPAP的影响
如图1所示,大鼠在低压低氧环境饲养14天后,模型组大鼠的mPAP明显升高,差异具有显著性(P<0.001)。在低压低氧环境下,与溶剂对照组相比,德式乳杆菌保加利亚亚种(L.bulgaricus)和瑞士乳杆菌(L.helveticus)组大鼠的mPAP明显降低,差异有统计学意义(P<0.05)。
2.2对大鼠RV/(LV+OS)的影响
如图2所示,大鼠在低压低氧环境饲养14天后,模型组大鼠的RV/(LV+OS)明显升高,差异具有显著性(P<0.001)。在低压低氧环境下,与溶剂对照组相比,德式乳杆菌保加利亚亚种(L.bulgaricus)和瑞士乳杆菌(L.helveticus)组大鼠的RV/(LV+OS)明显降低,差异有统计学意义(P<0.01)。
上述结果表明,德式乳杆菌保加利亚亚种(L.bulgaricus)和瑞士乳杆菌(L.helveticus)对模拟5500米高原环境大鼠的肺动脉高压、右心肥厚等具有保护作用,可以将其开发成保护对抗高原环境的药物。
最后应说明的是:以上各实施例仅用以说明本发明的技术方案,而非对其限制;尽管参照前述各实施例对本发明进行了详细的说明,但本领域的普通技术人员应当理解:其依然可以对前述各实施例所记载的技术方案进行修改,或者对其中部分或者全部技术特征进行等同替换;而这些修改或者替换,并不使相应技术方案的本质脱离本发明各实施例技术方案的范围。
Claims (7)
1.益生菌在制备预防和/或治疗高原病的药物中的应用,其特征在于,所述益生菌包括乳杆菌属;
所述乳杆菌属选自德式乳杆菌保加利亚亚种和/或瑞士乳杆菌;
所述的高原病选自在高原环境下产生的急性高原病和慢性高原病;
所述的高原环境为海拔2000m以上,具有低压、缺氧的条件。
2.根据权利要求1所述的应用,特征在于,所述预防和/或治疗高原病包括预防和/或改善高原病的症状。
3.根据权利要求1所述的应用,其特征在于,所述的急性高原病选自高原昏迷、高原脑水肿、高原肺水肿或脑、肺异常症状同时存在的混合型疾病;
所述的慢性高原病选自高原心脏病、高原红细胞增多症、高原高血压、高原低血压、高原心脏病、红细胞增多症同时存在的混合型疾病。
4.根据权利要求2所述的应用,其特征在于,所述的预防和/或改善高原病的症状选自预防和/或改善高原病引起的头痛、头昏、恶心呕吐、心慌气短、胸闷胸痛、失眠、嗜睡、食欲减退、腹胀或手足发麻中的一种或多种。
5.根据权利要求1所述的应用,其特征在于,所述的药物包括益生菌以及药学上可接受的辅料;
所述辅料选自载体、赋形剂、稀释剂、润滑剂、润湿剂、乳化剂、防腐剂、抗氧化剂、缓冲剂、等渗剂、悬浮剂、助悬剂、增溶剂、增稠剂、稳定剂、甜味剂以及香料中的一种或两种以上组合。
6.根据权利要求1所述的应用,其特征在于,所述药物的制剂形式为肠道组合药的剂型。
7.根据权利要求6所述的药物,其特征在于,所述肠道给药剂型包括片剂、颗粒剂、胶囊、乳剂、混悬剂、酏剂、糖浆剂、粉剂、片剂。
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