CN111107854B - 包含β-葡聚糖作为有效成分的宿醉解除用组合物或酒精性肝病预防、改善或治疗用组合物 - Google Patents
包含β-葡聚糖作为有效成分的宿醉解除用组合物或酒精性肝病预防、改善或治疗用组合物 Download PDFInfo
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Abstract
本发明涉及包含β‑葡聚糖(β‑glucan)作为有效成分的宿醉解除用组合物或酒精性肝病预防、改善或治疗用组合物。
Description
技术领域
本发明涉及包含β-葡聚糖(尤其,来源于裂褶菌的β-葡聚糖)作为有效成分的宿醉解除用组合物或酒精性肝病预防、改善或治疗用组合物。
背景技术
饮酒为全世界蔓延的生活习惯,适当的酒精摄取有利于社交及健康增进,从而可滋润生活,但过量饮酒可诱发宿醉引起的恶心、呕吐、口渴、头痛及肌肉痛,从而导致日常生活的障碍。并且,长期的酒精摄取抑制体内营养素的吸收或代谢过程来引起营养缺乏,并引起酒精性脂肪肝、肝炎、肝硬变等的肝病和癌、糖尿、心血管***疾病、神经精神障碍等,从而产生巨大的社会经济损失。不仅如此,长期的酒精代谢诱导低血糖和低体重,从而引起能量代谢的不均衡。
当人类饮酒时,人体经过吸收酒精并分解的过程。将这种过程称为酒精代谢过程,进入的大部分酒精在肝中进行处理,从而以乙醛氧化,并重新以乙酸氧化。并且,乙酸与氧相汇来分解为二氧化碳和水。参与酒精代谢过程的酶有乙醇脱氢酶(ADH,Al coholdehydrogenase)和醛脱氢酶(ALDH,Aldehyde dehydrogenase)。当酒精进入体内时,发生宿醉及副作用。宿醉现象是指饮酒后产生疲劳感、睡眠障碍、心悸亢进、颤抖、呕吐等各种副作用的现象,这种现象的主要原因为体内积累的乙醛。从进入体内的肝中分解的酒精生成乙醛,这种物质在生物体内具有毒性。乙醛使肝细胞直接损伤,一边沿着体内的血管转来转去一边产生各种副作用。呈现饮酒后身体发红的现象的人是因为没有分解乙醛的多种酶或多种酶不足,且是因为由于积累的乙醛使血管扩张来使脸部发红,并气喘。并且,可在肝中分解的规定量以上的酒精沿着血液传递至脑,从而影响脑的功能,以刺激中枢神经***,导致判断能力降低。并且,当因酒精代谢结果而生成的乙酸不分解为二氧化碳和水时,过度生成脂肪酸,以使脂肪过度积累于肝组织,从而诱导酒精性脂肪肝。因此,对于可去除酒精摄取导致的宿醉,并抑制肝损伤的物质的关注度持续增加,活跃地进行与此相关的研究。在酒精肝病研究领域中,最近,主要在病态生理学方面和治疗领域中得到进步。在实验室和动物实验水平上,持续进行肝病研究,基于这些结果试图临床实验。在治疗方面,自1971年对严重的酒精肝炎导入类固醇治疗以来,最近,2000年为止,是唯一的治疗剂。此外,很多新的治疗剂处于临床研究中,在2014年最近研究中,通过动物实验证明利用枳椇果提取液发酵物的肝损伤和体重减轻缓解效果。
β-葡聚糖作为葡萄糖以β-1,3化学键为中心聚合的多糖类,有从蘑菇、酵母等的微生物的细胞壁或细胞的多糖类分离来生产的来源于微生物的β-葡聚糖(β-1,3-葡聚糖或β-1,3-1,6-葡聚糖)和从大麦、燕麦之类的谷物的膳食纤维提取来生产的植物性β-葡聚糖(β-1,3-1,4-葡聚糖)。这些可根据更具体的葡萄糖结合结构来呈现多种生物活性,并且,作为高附加价值的生物材料,多样地利用化妆品的添加剂、保健品、食品添加剂、混凝土外加剂、饲料添加剂等。
尤其,众所周知,存在于裂褶菌(Schizophyllum commune)的裂褶菌多糖(Schizophyllan)等的β-(1,6)-分支的(1,3)-葡聚糖(glucan)的形态的β-葡聚糖(β-Gluc an)增强免疫力,同时与无耐性的天然免疫调节剂报告有对于抗癌及抗氧化的生物活性等。众所周知,β-葡聚糖为作用于人体的免疫***来增强人体的免疫力的所谓的生物反应调节剂(BRM,biological response modifiers),尤其,据报告,β-葡聚糖激活免疫***内的巨噬细胞(macrophage)的功能来使这种巨噬细胞分泌作为其他淋巴细胞或白细胞的增殖因子的干扰素或白细胞介素等的细胞因子,从而强化免疫***的整体功能。并且,当添加于小鸡饲料时,能够以免疫调节剂预防沙门氏菌(salmonella)。尤其,作为用于提高来源于酵母的β-葡聚糖的功效的一个环节,进行对于酵母诱发人为突变来诱导细胞壁的变异的研究,指出从变异得到的β-葡聚糖的免疫及抗癌相关活性优秀。
发明内容
技术问题
本发明提供包含β-葡聚糖(β-glucan)作为有效成分的宿醉解除用药学组合物等。
但是,本发明所要实现的技术问题不局限于以上提及的问题,本发明所属技术领域的普通技术人员可从以下记载内容中明确地理解未提及的其他多个问题。
解决问题的方案
本发明提供包含β-葡聚糖(β-glucan)作为有效成分的宿醉解除用药学组合物。
上述组合物可用于抑制宿醉引起的副作用。
上述副作用可以为体重增加、肝毒性或血中胆固醇含量增加引起的副作用。
上述β-葡聚糖可从裂褶菌(Schizophyllum commune)或其的培养物分离。
上述β-葡聚糖可具有β-(1,6)-分支的(1,3)-葡聚糖的结构。
相对于上述组合物的总重量,上述β-葡聚糖的含量可以为0.001重量百分比至50重量百分比。
作为本发明的一实例,提供包含β-葡聚糖(β-glucan)作为有效成分的酒精性肝病预防或治疗用药学组合物。
作为本发明的还一实例,提供用于将β-葡聚糖(β-glucan)使用于宿醉解除用药学组合物的用途。
作为本发明的又一实例,提供用于将β-葡聚糖(β-glucan)使用于酒精性肝病预防或治疗用药学组合物的用途。
作为本发明的又一实例,提供包括将β-葡聚糖(β-glucan)给药到个体的步骤的宿醉解除方法。
作为本发明的又一实例,提供包括将β-葡聚糖(β-glucan)给药到个体的步骤的酒精性肝病治疗方法。
发明的效果
本发明涉及包含β-葡聚糖(β-glucan)作为有效成分的宿醉解除用组合物或酒精性肝病预防、改善或治疗用组合物,上述组合物具有不仅可分解酒精或乙醛来解除宿醉,还可抑制宿醉引起的副作用,即,体重增加、肝毒性及血中胆固醇含量增加的优点。因此,根据上述组合物,期待能够以对生物体安全且无宿醉引起的副作用的方式解除宿醉。
不仅如此,本发明的组合物具有酒精性肝病的预防、改善或治疗效果。
附图说明
图1为在实验组1及比较实验组1~比较实验组3中,开始将β-葡聚糖或磷酸盐缓冲液进行给药之后,每1小时、每2小时及每4小时采血来分离血清,从而测定酒精分解酶及乙醛分解酶活性、血中酒精及乙醛浓度的结果的比较曲线图。
图2为在实验组1及比较实验组1~比较实验组3中,开始将β-葡聚糖或磷酸盐缓冲液进行给药之后,从5小时之后,以1小时的间隔进行6次采血来分离血清,从而测定血中酒精及乙醛浓度的结果的比较曲线图。
图3为在实验组1及比较实验组1~比较实验组3中,牺牲开始将β-葡聚糖或磷酸盐缓冲液进行给药的6周后小鼠之后,测定体重及肝的组织重量的结果的比较表。
图4为在实验组1及比较实验组1~比较实验组3中,牺牲开始将β-葡聚糖或磷酸盐缓冲液进行给药的6周后小鼠之后,执行血清分析的结果的比较表。
具体实施方式
本发明人为了以对生物体安全且无宿醉引起的副作用的方式解除宿醉而努力,最终,确认当将β-葡聚糖进行给药时,不仅可有效分解酒精或乙醛,还可全部抑制体重增加、肝毒性及血中胆固醇含量增加,并完成本发明。
以下,详细说明本发明。
宿醉解除用/酒精性肝病预防或治疗用药学组合物
本发明提供包含β-葡聚糖(β-glucan)作为有效成分的宿醉解除用药学组合物。
本发明的宿醉解除用药学组合物的特征在于,包含β-葡聚糖作为有效成分。
上述宿醉解除用药学组合物用于解除宿醉,这种宿醉解除效果可通过测定酒精分解酶及乙醛分解酶活性来进行确认,或通过测定血中酒精及乙醛浓度来进行确认。
并且,上述宿醉解除用药学组合物可用于抑制宿醉引起的副作用或酒精摄取伴随的副作用,具体地,上述副作用可以为体重增加、肝毒性或血中胆固醇含量增加引起的副作用。更具体地,这种体重增加与否可通过测定上述体重及血中甘油三酯含量来进行确认,这种肝毒性与否可通过测定肝的重量来进行确认,或通过GOT/AST数值及γ-GPT/ALT数值分析来进行确认。
并且,本发明提供包含β-葡聚糖(β-glucan)作为有效成分的酒精性肝病预防或治疗用药学组合物。
上述酒精性肝病预防或治疗用药学组合物用于预防或治疗酒精性肝病,此时,酒精性肝病由因酒精而诱导的肝损伤引起,优选为包括肝炎、肝硬变症及脂肪肝的一种以上的疾病,但不局限于此。这种酒精性肝病预防或治疗效果可通过测定因酒精而诱导的肝的重量来进行确认,或通过GOT/AST数值及γ-GPT/ALT数值分析来进行确认。
上述β-葡聚糖为了第一次分解酒精或乙醛,第二次抑制宿醉引起的副作用,即,体重增加、肝毒性及血中胆固醇含量增加,或预防、改善或治疗酒精性肝病而进行给药,优选地,具有β-(1,6)-分支的(1,3)-葡聚糖的结构,但不局限于此。上述β-葡聚糖可来源于微生物菌体、酵母菌体或蘑菇菌丝体,更具体地,可从裂褶菌(Schiz ophyllum commune)或其的培养物分离,但不局限于此。
为了从裂褶菌分离上述β-葡聚糖,可从以液态方式培养的培养物得到裂褶菌菌丝体。更具体地,根据韩国授权专利第10-0892355号或韩国授权专利第10-0909857号中所公知,培养裂褶菌,并从其的培养物分离及得到β-葡聚糖,这是更优选的,但不局限于此。
相对于上述药学组合物的总重量,上述β-葡聚糖的含量优选为0.001重量百分比至50重量百分比,更优选为0.005重量百分比至20重量百分比,但不局限于此。
本发明的药学组合物可分别根据通常的方法来以散剂、颗粒剂、片剂、胶囊剂、悬浮液、乳液、糖浆等的口服剂剂型、外用剂、栓剂及灭菌注射溶液的形态进行剂型化而使用,为了剂型化,可包含通常用于制备药学组合物的适当的载体、赋形剂或稀释剂。
作为上述载体或赋形剂或稀释剂,可例举包含乳糖、葡萄糖、蔗糖、山梨糖醇、甘露醇、木糖醇、赤藓糖醇、麦芽糖醇、淀粉、***胶、海藻酸盐、明胶、磷酸钙、硅酸钙、纤维素、甲基纤维素、微晶纤维素、聚乙烯吡咯烷酮、水、羟基苯甲酸甲酯、羟基苯甲酸丙酯、滑石、硬脂酸镁及矿物油等的多种化合物或混合物。
当进行制剂化时,可利用通常使用的填充剂、重量剂、结合剂、湿润剂、崩解剂、表面活性剂等的稀释剂或赋形剂来进行制备。
用于口服给药的固体制剂可通过在上述β-葡聚糖中混合至少一种的赋形剂,例如,淀粉、硼酸钙、蔗糖或乳糖、明胶等来进行制备。并且,除了单纯的赋形剂之外,还可使用硬脂酸镁、滑石之类的润滑剂。
作为用于口服的液态制剂,有悬浮液、内服溶液剂、乳剂、糖浆剂等,除了作为常使用的单纯稀释剂的水、液体石蜡之外,可包含多种赋形剂,例如,湿润剂、甜味剂、芳香剂、保鲜剂等。
用于非口服给药的制剂包含灭菌的水溶液、非水性溶剂、悬浮剂、乳剂、冷冻干燥制剂、栓剂。作为非水性溶剂、悬浮剂,可使用丙二醇、聚乙二醇、橄榄油之类的植物油、油酸乙酯之类的可注射的酯等。作为栓剂的基剂,可使用威泰索尓(witepso l)、聚乙二醇、吐温(tween)61、可可脂、月桂酯、甘油明胶等。
本发明的药学组合物的优选给药量可根据患者的状态、体重、疾病的程度、药物形态、给药途径及期间而不同,但可由本发明所属技术领域的普通技术人员适当地进行选择。但是,为了优选效果,能够以一天0.0001μg/kg至400mg/kg进行给药,更优选地,以0.001mg/kg至200mg/kg进行给药。可一天一次进行给药,也可分多次进行给药。只是,本发明的范围不局限于上述给药量。
本发明的药学组合物能够以多种途径给药到大鼠、小鼠、家畜、人类等的哺乳动物。作为给药的所有方式,例如,可通过口服、非口服、直肠或静脉、肌肉、皮下、子宫内硬膜或脑血管内(intracerebroventricular)注射来进行给药。
进而,本发明提供用于将β-葡聚糖(β-glucan)使用于宿醉解除用药学组合物的用途。
并且,本发明提供用于将β-葡聚糖(β-glucan)使用于酒精性肝病预防或治疗用药学组合物的用途。
并且,本发明提供包括将β-葡聚糖(β-glucan)给药到个体的步骤的宿醉解除方法。
并且,本发明提供包括将β-葡聚糖(β-glucan)给药到个体的步骤的酒精性肝病治疗方法。
在本发明中,“个体”是指需要治疗疾病的对象,更具体地,是指人类或非-人类的灵长类、小鼠(mouse)、大鼠(rat)、狗、猫、马及牛等的哺乳类。
如上所述,本发明涉及包含β-葡聚糖(β-glucan)作为有效成分的宿醉解除用组合物或酒精性肝病预防或治疗用组合物,上述组合物具有不仅可分解酒精或乙醛来解除宿醉,还可抑制宿醉引起的副作用,即,体重增加、肝毒性及血中胆固醇含量增加的优点。因此,根据上述组合物,期待以对生物体安全且无宿醉引起的副作用的方式解除宿醉。
不仅如此,本发明的组合物具有酒精性肝病的预防、改善或治疗效果。
以下,为了有助于理解本发明,提出优选实施例。但是,以下实施例仅用于更加容易理解本发明,本发明的内容不局限于以下实施例。
实施例
实施例1:当短时间摄取酒精时,通过将β-葡聚糖进行给药来得到的酒精分解效果
的确认(动物实验)
购买6周龄的野生型C57BL/6小鼠,并饲养3天来使其适应环境之后,进行饲养。具体地,以每组5只的方式将小鼠分为共4组,并如表1中所示,在实验组1和比较实验组1中,将20%的酒精(EtOH)0.2ml进行口服给药,经过30分钟之后,在实验组1中,将0.2ml的来源于裂褶菌的β-葡聚糖(具有β-(1,6)-分支的(1,3)-葡聚糖的结构的裂褶菌多糖(SPG))(制造商:贵真生物技术)(浓度=1.6mg/ml)进行口服给药,在比较实验组1中,将磷酸盐缓冲液(PBS,Phosphate buffer solution)进行口服给药来替代裂褶菌多糖。另一方面,在比较实验组2、比较实验组3中,在无酒精给药的情况下,分别将裂褶菌多糖及磷酸盐缓冲液进行口服给药。
表1
在短时间摄取酒精的动物模型中,确认到是否随着将β-葡聚糖进行口服给药,呈现酒精分解酶(乙醇脱氢酶(ADH,Alcohol Dehydrogenase))及乙醛分解酶(ALDH,NAD依赖性醛脱氢酶(NAD-dependent Aldehyde Dehydrogenase))活性增加、血中酒精及乙醛浓度减少效果。
具体地,在实验组1及比较实验组1~比较实验组3中,开始将β-葡聚糖或磷酸盐缓冲液进行给药之后,每1小时、每2小时及每4小时进行采血来分离血清,从而测定酒精分解酶及乙醛分解酶活性、血中酒精及血中乙醛浓度,并将其结果示于图1中。
如图1所示,在短时间摄取酒精之后,将β-葡聚糖进行口服给药的实验组1中,确认到与比较实验组1相比,酒精及乙醛分解酶活性均大大增加。只是,在短时间不摄取酒精,而将β-葡聚糖进行口服给药的比较实验组2中,未确认到这种酶活性的增加。
并且,在实验组1中,确认到与比较实验组1相比,血中酒精及血中乙醛浓度均大大减少。
实施例2:当长时间摄取酒精时,通过将β-葡聚糖进行给药来得到的酒精分解效果
的确认(动物实验)
购买6周龄的野生型C57BL/6小鼠,并饲养3天来使其适应环境之后,进行饲养。具体地,以每组5只的方式将小鼠分为共4组,并如表2中所示,在实验组1和比较实验组1中,将20%的酒精(EtOH)0.2ml进行口服给药,经过30分钟之后,在实验组1中,将0.2ml的来源于裂褶菌的β-葡聚糖(具有β-(1,6)-分支的(1,3)-葡聚糖的结构的裂褶菌多糖(SPG))(制造商:贵真生物技术)(浓度=1.6mg/ml)进行口服给药,在比较实验组1中,将磷酸盐缓冲液(PBS,Phosphate buffer solution)进行口服给药来替代裂褶菌多糖。以1小时的间隔将这种过程连续实施共4次。另一方面,在比较实验组3、比较实验组4中,在无酒精给药的情况下,以相同时间的间隔分别将裂褶菌多糖及磷酸盐缓冲液口服给药共4次。
表2
在长时间摄取酒精的动物模型中,确认到是否随着将β-葡聚糖进行口服给药,呈现血中酒精及血中乙醛浓度减少效果。
具体地,在实验组1及比较实验组1~比较实验组3中,开始将β-葡聚糖或磷酸盐缓冲液进行给药之后,从5小时之后,以1小时的间隔进行6次采血来分离血清,从而测定血中酒精及乙醛浓度,并将其结果示于图2中。
如图2所示,在长时间摄取酒精之后将β-葡聚糖进行口服给药的实验组1中,确认到与比较实验组1相比,血中酒精及血中乙醛浓度均大大减少。
实施例3:当长时间摄取酒精时,通过将β-葡聚糖进行给药来得到的宿醉引起的副
作用抑制效果或酒精性肝病治疗效果的确认(动物实验)
购买6周龄的野生型C57BL/6小鼠,并饲养3天来使其适应环境之后,进行饲养。具体地,以每组5只的方式将小鼠分为共4组,并如表3中所示,在实验组1和比较实验组1中,将20%的酒精(EtOH)0.2ml进行口服给药,经过30分钟之后,在实验组1中,将0.2ml的来源于裂褶菌的β-葡聚糖(具有β-(1,6)-分支的(1,3)-葡聚糖的结构的裂褶菌多糖(SPG))(制造商:贵真生物技术)(浓度=1.6mg/ml)进行口服给药,在比较实验组1中,将磷酸盐缓冲液(PBS,Phosphate buffer solution)进行口服给药来替代裂褶菌多糖。以1小时的间隔将这种过程连续实施共4次。另一方面,在比较实验组3、比较实验组4中,在无酒精给药的情况下,以相同时间的间隔分别将裂褶菌多糖和磷酸盐缓冲液口服给药共4次。以每周5次的方式将这些反复共6周。
表3
在长时间摄取酒精的动物模型中,确认到是否随着将β-葡聚糖进行口服给药,呈现宿醉引起的副作用抑制效果及酒精性肝病治疗效果。
具体地,在实验组1及比较实验组1~比较实验组3中,牺牲开始将β-葡聚糖或磷酸盐缓冲液进行给药的6周后小鼠之后,测定体重及肝的组织重量,并将其结果示于图3中。并且,执行血清分析,并将其结果示于图4中。
如图3所示,在长时间摄取酒精之后,将β-葡聚糖进行口服给药的实验组1中,确认到与比较实验组1相比,体重及肝的组织重量大大减少。并且,如图4所示,在实验组1中,确认到与比较实验组1相比,不仅血中甘油三酯含量减少,血中胆固醇含量大大减少,血中GOT/AST数值及γ-GPT/ALT数值也大大减少。
以下,说明包含本发明的化合物的组合物的制剂例,但本发明仅用于具体说明,而不是对其进行限制。
制剂例1:散剂的制备
20mg的β-葡聚糖
100mg的乳糖水化物
10mg的滑石
混合上述的多种成分,并填充于气密布来制备散剂。
制剂例2:片剂的制备
10mg的β-葡聚糖
100mg的玉米淀粉
100mg的乳糖水化物
2mg的硬脂酸镁
混合上述的成分之后,按照通常的片剂的制备方法进行压片来制备片剂。
制剂例3:胶囊剂的制备
10mg的β-葡聚糖
3mg的微晶纤维素
14.8mg的乳糖水化物
0.2mg的硬脂酸镁
混合上述的成分之后,按照通常的胶囊剂的制备方法填充于明胶胶囊来制备胶囊剂。
制剂例4:注射剂的制备
10mg的β-葡聚糖
180mg的甘露醇
2974mg的注射用灭菌蒸馏水
26mg的磷酸一氢钠
混合上述的成分之后,按照通常的注射剂的制备方法以上述的成分含量将每1安瓿(2mL)进行制备。
制剂例5:液剂的制备
10mg的β-葡聚糖
10g的异构糖
5g的甘露醇
适量的纯化水
适量的柠檬香
对于上述的成分,按照通常的制备方法在纯化水中添加各自的成分来进行溶解,并添加适量的柠檬香之后,添加纯化水来调节成共100mL之后进行灭菌,从而填充于褐色瓶来制备液剂。
上述的本发明的说明用于例示,本发明所属技术领域的普通技术人员应当理解可在不变更本发明的技术思想或必要特征的情况下以其他具体的形态容易变形。因此,应当仅理解为以上记述的实施例在所有方面是例示性的,而非限定。
Claims (3)
1.一种β-葡聚糖作为有效成分在制备用于宿醉解除和抑制宿醉引起的副作用的药学组合物中的应用,其特征在于,所述β-葡聚糖具有β-(1,6)-分支的(1,3)-葡聚糖的结构,
其中,所述β-葡聚糖从裂褶菌或其的培养物分离,以及
所述副作用是体重增加或血中胆固醇含量增加。
2.根据权利要求1所述的应用,其特征在于,相对于上述药学组合物的总重量,上述β-葡聚糖的含量为0.001重量百分比至50重量百分比。
3.一种β-葡聚糖作为有效成分在制备用于预防或治疗酒精性肝病的药学组合物中的应用,其特征在于,所述β-葡聚糖具有β-(1,6)-分支的(1,3)-葡聚糖的结构,
其中,所述β-葡聚糖从裂褶菌或其的培养物分离。
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KR20180042936A (ko) * | 2016-10-19 | 2018-04-27 | 휴코스코리아(주) | 치마버섯 분리 균사체 배양액을 유효성분으로 함유하는 숙취해소 및 간질환의 예방 및 치료용 약학조성물 |
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- 2018-08-29 US US16/646,854 patent/US11154568B2/en active Active
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JP2004075692A (ja) * | 2003-11-12 | 2004-03-11 | Itsukou Kagaku Kk | 組成物及びそれからなる飲料 |
KR100707917B1 (ko) * | 2005-12-06 | 2007-04-13 | 주식회사 글루칸 | 베타 글루칸을 유효성분으로 포함하는 간질환 치료용 약학조성물 |
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CN111107854A (zh) | 2020-05-05 |
US20210008094A1 (en) | 2021-01-14 |
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KR102118731B1 (ko) | 2020-06-03 |
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