CN115768417A - 肌肉萎缩抑制剂 - Google Patents
肌肉萎缩抑制剂 Download PDFInfo
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- CN115768417A CN115768417A CN202180039909.6A CN202180039909A CN115768417A CN 115768417 A CN115768417 A CN 115768417A CN 202180039909 A CN202180039909 A CN 202180039909A CN 115768417 A CN115768417 A CN 115768417A
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Abstract
本发明提供用于人等的用于抑制肌肉萎缩的材料(制剂)等。本发明是含有菜蓟苦素的用于抑制肌肉萎缩的制剂、含有洋蓟提取物的用于抑制肌肉萎缩的制剂等。
Description
交叉引用
本申请主张基于在日本2020年6月2日提出申请的日本特愿2020-95925号和2021年1月28日提出申请的日本特愿2021-12033号的优先权,该申请记载的全部内容通过参照而直接援引于本说明书。另外,本申请中引用的所有专利、专利申请和文献记载的全部内容通过参照而直接援引于本说明书。
技术领域
本发明涉及用于抑制肌肉萎缩的材料等。
背景技术
因卧床不起、不活动、饥饿、年龄增长等,在人体内产生骨骼肌的萎缩。在迎来超老龄化社会的日本,从延长人的健康寿命的观点出发,认为抑制肌肉萎缩是很重要的事项。
肌肉萎缩大致分为废用性肌肉萎缩和进行性肌肉萎缩,其中,废用性肌肉萎缩是因长期的不活动而产生的骨骼肌的显著变化,且是肌纤维直径的减少等量的变化以及肌纤维、肌肉蛋白质水平的类型转移的质的变化,例如,因长期的安静卧床、骨折等引起的石膏固定、暴露于微小重力(在宇宙空间等中的生活)、年龄增长过程等而产生(专利文献1)。
例如,对于老年人而言,肌肉力量被诱导下降,且基于此的跌倒等导致的骨折的风险增加、卧床不起等陷入需要护理状态的情况也很多。作为改善上述肌肉萎缩的方法,认为肌肉力量训练、重量训练、有氧运动等运动是有效的,但对于无法运动的处于护理状态的人员等而言,需要用于预防和/或改善肌肉萎缩(运动以外的方法)(非专利文献1)。
另外,例如,在肥胖且没有运动习惯的中老年人和糖尿病患者等(也包括肌少性肥胖的患者)中,表现出发生膝的伸展肌肉力量减少、下肢的无脂肪重量减少等的可能性高。对于这类患者也需要用于预防和/或改善肌肉萎缩的方法(运动以外的方法)(非专利文献2)。
现有技术文献
专利文献
专利文献1:日本特开2014-62068号公报
非专利文献
非专利文献1:Jpn J Rehabil Med 2007;44:144-170
非专利文献2:日老医志2014;51:99-108
发明内容
发明要解决的课题
本发明提供用于人等的用于抑制肌肉萎缩的材料(制剂)等。
用于解决问题的技术方案
本发明是为了解决上述课题而完成的,本发明人研究了具有抑制肌肉萎缩的作用的天然物(洋蓟等),结果发明了本发明。
本发明包括以下实施方式。
(1)一种用于抑制肌肉萎缩的制剂,其含有菜蓟苦素。
(2)一种用于抑制肌肉萎缩的制剂,其含有洋蓟提取物。
(3)一种口服组合物,其含有(1)或(2)记载的制剂。
(4)根据(3)记载的口服组合物,其中,人类成人每日优选摄取0.01mg/kg/日~12.0mg/kg/日的菜蓟苦素。
发明效果
本发明的制剂等能够用于抑制人等的肌肉萎缩。
附图说明
图1是通过光学显微镜来确认组3的该切片的结果。
具体实施方式
(菜蓟苦素)
菜蓟苦素(Cynaropicrin,PubChem CID:119093)是倍半萜(Sesquiterpene)的一种,其是由以下(式I)表示的化合物,分子式为C19H22O6。
(洋蓟)
洋蓟(Artichoke、Globe artichoke、学名为Cynara scolymus)是菊科菜蓟属的多年生植物。洋蓟的日本名为菜蓟(朝鲜蓟)。在本发明中,使用洋蓟的花、叶、茎、枝、枝叶、地上部分或整个植物的提取物,在本发明中,从更多含有上述菜蓟苦素等观点出发,优选使用洋蓟的叶或枝叶的提取物。
本发明中使用的获得洋蓟的提取物的提取溶剂,例如,可举出水、低级醇类(甲醇、乙醇、1-丙醇、2-丙醇、1-丁醇、2-丁醇等)、液态多元醇类(1,3-丁二醇、丙二醇、甘油等)、酮类(丙酮、甲乙酮等)、乙腈、酯类(乙酸乙酯、乙酸丁酯等)、烃类(己烷、庚烷、石油醚等)、醚类(乙醚、四氢呋喃、丙醚等)。这些溶剂可以使用一种,也可以混合使用两种以上。
上述提取物可以直接使用提取得到的溶液,也可以根据需要进行浓缩、稀释、过滤、利用活性炭等的脱色、除臭、乙醇沉淀等处理而使用。此外,也可以对提取得到的溶液进行浓缩干燥、喷雾干燥、冷冻干燥等处理,以干燥物的形式使用。
本发明中使用的洋蓟提取物的每日摄取量(以口服组合物的形式进行摄取时)能够根据摄取方式、使用目的、年龄、体重等进行适当调整,为了发挥期望的效果(肌肉萎缩的抑制效果等),将洋蓟提取物换算成干燥物,人类成人每日优选10mg/kg/日以上,更优选25mg/kg/日以上,进一步优选50mg/kg/日以上,从该摄取时对人等的安全性等观点出发,优选1000mg/kg/日以下,更优选750mg/kg/日以下,进一步优选500mg/kg/日以下。
本发明中使用的菜蓟苦素的每日摄取量(以口服组合物的形式进行摄取时)能够根据摄取方式、使用目的、年龄、体重等进行适当调整,为了发挥期望的效果(肌肉萎缩的抑制效果等),人类成人每日优选0.01mg/kg/日以上的菜蓟苦素,更优选0.025mg/kg/日以上,更优选0.05mg/kg/日以上,更优选0.10mg/kg/日以上,更优选为0.25mg/kg/日以上,进一步优选为0.50mg/kg/日以上,从该摄取时对人等的安全性等观点出发,优选12.0mg/kg/日以下,更优选9.00mg/kg/日以下,进一步优选6.00mg/kg/日以下。。
(洋蓟提取物的制备)
本发明中使用的洋蓟提取物,例如能够通过以下制造例1、制造例2的制造方法来制备。以下实施例记载的洋蓟提取物是由以下制造例1制备得到的洋蓟提取物。
(制造例1)洋蓟的叶热水提取物的制造方法
将洋蓟的叶100g添加至200mL的纯化水中,在95~100℃提取约45分钟后,过滤、浓缩后,添加赋形剂进行调整,干燥后,得到提取物粉末(洋蓟提取物的实例即洋蓟的叶热水提取物)约6g。在该粉末中,含有上述菜蓟苦素1.0709质量%。
(制造例2)洋蓟的叶乙醇提取物的制造方法
将洋蓟的叶干燥物100g添加至400mL的45%乙醇溶液中,在65~70℃提取约两小时后,过滤、浓缩后,添加赋形剂进行调整,干燥后,得到提取物粉末(洋蓟提取物的示例即洋蓟的叶乙醇提取物)约50g。在该粉末中,含有上述菜蓟苦素1.0709质量%。
(肌肉萎缩抑制剂)
本发明涉及的用于抑制肌肉萎缩的制剂(用于抑制肌肉萎缩的材料)的形态,没有特别限制,例如,可举出液体的形态、固体的形态、粉末状的形态等。
(口服组合物)
本发明涉及的口服组合物,例如为饮食品(也包括功能性标示食品、特定保健用食品、补充品等)、药品等。
例如,在该口服组合物为饮食品的情况下,该饮食品的形态可举出面包类、蛋糕类、面类、点心类、果冻类、冷冻食品、冰淇淋类、乳制品、饮料等各种饮食品、以及与上述口服制剂相同的形态(片剂、胶囊剂、糖浆等)。各种形态的食品能够单独使用本发明的有效成分制备,或者,适当组合其他食品材料、溶剂、软化剂、油、乳化剂、防腐剂、香科、稳定剂、着色剂、抗氧化剂、保湿剂、增稠剂等而制备。
例如,在该口服组合物为医药品的情况下,该医药品容易组装便利的每日剂量方案(regimen),上述每日剂量方案通常能够根据痛苦的程度而调节,该医药品的形态例如为固体的形态、液体的形态。该固体的形态例如可举出:粉末剂、片剂、丸剂、胶囊剂、扁囊剂(cachet)、含片剂(troche)、栓剂和分散性颗粒剂等。例如,在粉末剂中,载体通常是与微粉化的活性成分的混合物即微粉化的固体。例如,在片剂中,活性成分通常以适当的比例与具有需要的结合能力的载体混合,成型为期望的形状和大小。适当的载体,例如,非限制性地包含碳酸镁、硬脂酸镁、滑石、糖、乳糖、果胶、糊精、淀粉、明胶、黄蓍胶、甲基纤维素、羧甲基纤维素钠、低熔点蜡、可可脂等。该医药品在不损害期望的效果的范围内,根据需要还能够含有赋形剂、稳定剂、保存剂、结合剂、崩解剂、烃类、脂肪酸类、醇类、酯类、pH调节剂、防腐剂等成分。
肌肉萎缩是肌肉变瘦。如果肌肉萎缩,则肌肉力量也降低。肌肉萎缩例如包括由肌肉自身的疾病引起的情况(肌原性肌肉萎缩)和由直接向肌肉传达运动指令的运动神经的障碍引起的情况(神经原性肌肉萎缩)。通常,在肌肉的疾病中,从肩膀到双臂、从腰部到大腿的肌肉(近端肌)容易萎缩,而在神经疾病中,手脚的前端的肌肉(四肢的远端肌)容易萎缩。代表性的肌肉疾病包括肌肉萎缩症等遗传性肌疾病、多发肌炎·皮肤肌炎等炎症性肌疾病。神经原性肌肉萎缩大多是因末梢神经的障碍(神经病变)而产生,其也包括外伤、压迫引起的障碍、炎症性障碍、遗传性障碍等多种原因。
以下列举实施例,更详细说明本发明,本发明不受这些实施例的任何限制。应予说明,在以下实施例中,表示本发明的制剂等中含有的成分等的含量的数值的单位%意味着质量%。
实施例
以下,对本发明的实施例进行说明。
[实验1:肌肉的萎缩抑制作用的评价]
使用实验动物(小鼠),对含有菜蓟苦素的口服组合物进行肌肉的萎缩抑制作用的评价(实验)。该评价通过测定比目鱼肌的重量来进行。
以下记载实验方法。首先,购入5周龄的雄性KKAy小鼠(日本科力亚株式会社)40只。该KKAy小鼠为糖尿病模型小鼠。对该购入的小鼠进行1周的常规饲养(自由给予常见饵料和水的饲养)。
进行该1周的常规饲养后,以1组10只设定以下4个实验组,进行7周(49天)基于以下设定的饲养(自由给予常见饵料和以下组所示的水的饲养)。
·对照组:通过饮水,对该小鼠给予食物纤维即糊精(松谷化学工业株式会社,麦芽糊精(Pinedex#1))500mg/kg/day的组。
·组1:通过饮水,对该小鼠给予通过制造例1制备得到的洋蓟的叶热水提取物100mg/kg/day的组。即,通过饮水,给予菜蓟苦素1.0709mg/kg/day的组。对小鼠给予菜蓟苦素1.0709mg/kg/day是以小鼠的人等价用量(Human equivalent dose,HED)12.3(参照资料“Guidance for Industry Estimating the Maximum Safe Starting Dose in InitialClinical Trials for Therapeutics in Adult Healthy Volunteers”)为基础,换算为对人类成人的给药量时,对人类成人给予菜蓟苦素0.0871mg/kg/day。
·组2:通过饮水,对该小鼠给予通过制造例1制备得到的洋蓟的叶热水提取物300mg/kg/day的组。即,通过饮水,给予菜蓟苦素3.2127mg/kg/day的组。对小鼠给予菜蓟苦素3.2127mg/kg/day是以该小鼠的人等价用量(HED)12.3为基础,换算为对人类成人的给药量时,对人类成人给予菜蓟苦素0.2612mg/kg/day。
·组3:通过饮水,对该小鼠给予通过制造例1制备得到的洋蓟的叶热水提取物500mg/kg/day的组。即,通过饮水,给予菜蓟苦素5.3545mg/kg/day的组。对小鼠给予菜蓟苦素5.3545mg/kg/day是以该小鼠的人等价用量(HED)12.3为基础,换算为对人类成人的给药量时,对人类成人给予菜蓟苦素0.4353mg/kg/day。
在该饲养7周后,测定小鼠的体重并在麻醉下从各组小鼠摘出比目鱼肌。测定该摘出的比目鱼肌的重量。
以下记载测定得到的结果。该测定是逐只对各组(各10只)的比目鱼肌(左右的比目鱼肌)进行测定。以下测定得到的结果是各组的每1只的左右的比目鱼肌的总计量的平均值(g)。对照组为0.0167(g),组1为0.01745(g),组2为0.0175625(g),组3为0.017075(g)。在组1、组2和组3中,与对照组相比,可确认到比目鱼肌的重量增加。
[实验2:肌肉的萎缩抑制作用的评价]
使用实验动物(小鼠),进一步对含有菜蓟苦素的口服组合物进行肌肉的萎缩抑制作用的评价(实验)。该实验2中的评价通过测量比目鱼肌的小束的规定部位的截面积(μm/像素)来进行。
以下记载实验方法。首先,购入5周龄的雄性KKAy小鼠(日本科力亚株式会社)20只。对该购入的小鼠进行1周的常规饲养(自由给予常见饵料和水的饲养)。
进行该1周的常规饲养后,以1组10只设定以下两个实验组,进行7周(49天)基于以下设定的饲养(自由给予常见饵料和以下组所示的水的饲养)。
·对照组:通过饮水,对该小鼠给予食物纤维即糊精(松谷化学工业株式会社、麦芽糊精(Pinedex#1))500mg/kg/day。
·组3:通过饮水,对该小鼠给予通过制造例1制备得到的洋蓟的叶热水提取物500mg/kg/day的组。即,通过饮水,给予菜蓟苦素5.3545mg/kg/day的组。对小鼠给予菜蓟苦素5.3545mg/kg/day是以该小鼠的人等价用量(HED)12.3为基础,换算为对人类成人的给药量时,对人类成人给予的菜蓟苦素0.4353mg/kg/day。
在该饲养7周后,测定小鼠的体重并在麻醉下从各组小鼠摘出比目鱼肌。测定该摘出的比目鱼肌的小束的规定部位的截面积。
为了进行该测定,通过常规方法由对照组的小鼠的比目鱼肌和组3的小鼠的比目鱼肌制备各组的石蜡切片。对该切片进行苏木精·伊红(HE)染色。使用该染色得到的切片,随机选择在各组切片中能够确认到的小束1100根,测定该1100根的平均截面积。以特定的倍率通过光学显微镜的观察来确认该小束。通过使用WinROOF进行定量(μm/pixel)来测定该截面积。
将测定结果(该平均截面积)记载于以下。对照组中为2243.72(μm/pixel),与此相对,组3中为2735.45(μm/pixel)。该组3的值与对照组相比有显著差异(student t检验(Student t-test),p<0.05(p=0.044049)。因此,与对照组相比,组3中能够确认到显著的肌肉的萎缩抑制作用。
此外,将通过光学显微镜确认组3的该切片得到的结果示于图1。将通过光学显微镜(倍率40倍)确认到的比目鱼肌示于图1中的(1),将通过光学显微镜(倍率400倍)确认到的比目鱼肌的小束示于图1中的(2)。在图1中的(1)中,条表示1.0mm(1000μm)。在图1中的(2)中,条表示100μm。
[实验3:肌肉的萎缩抑制作用的评价]
使用在狭小空间内饲养的实验动物(小鼠),进一步评价(实验)含有菜蓟苦素的口服组合物的肌肉的萎缩抑制作用。该实验3中的评价通过测定比目鱼肌重量来进行。
以下记载实验方法。首先,购入7周龄的雄性KKAy小鼠(纪和实验动物研究所公司)40只。对该购入的小鼠进行1周的常规饲养(自由给予常见饵料和水的饲养)。
进行该1周的常规饲养后,以1组10只按照以下方式设定以下4个实验组。进行4周(28天)基于以下设定的饲养。
(实验3中的实验组的设定)
·组4(常规饲养组):通过使用胃管的强制口服给药,对该小鼠给予食物纤维即糊精(松谷化学工业株式会社、麦芽糊精(Pinedex#1))300mg/kg/day的组。不在极小空间内饲养,自由给予常见饵料和饮水进行饲养。
·组5(狭小空间的饲养组):通过使用胃管的强制口服给药,对该小鼠给予食物纤维即糊精(松谷化学工业株式会社、麦芽糊精(Pinedex#1))300mg/kg/day的组。在狭小空间内饲养,自由给予常见饵料和饮水进行饲养。
·组6(狭小空间的饲养组):通过使用胃管的强制口服给药,对该小鼠给予通过制造例1制备得到的洋蓟的叶热水提取物300mg/kg/day的组。即,通过饮水,给予菜蓟苦素3.2127mg/kg/day的组。在狭小空间内饲养,自由给予常见饵料和饮水进行饲养。对小鼠给予菜蓟苦素3.2127mg/kg/day是以该小鼠的人等价用量(HED)12.3为基础,换算为对人类成人的给药量时,对人类成人给予菜蓟苦素0.2612mg/kg/day。
·组7(狭小空间的饲养组):通过使用胃管的强制口服给药,对该小鼠给予通过制造例1制备得到的洋蓟的叶热水提取物100mg/kg/day的组。即,通过饮水,给予菜蓟苦素1.0709mg/kg/day的组。在狭小空间内进行饲养,自由给予常见饵料和饮水进行饲养。对小鼠给予的菜蓟苦素1.0709mg/kg/day是以该小鼠的人等价用量(HED)12.3为基础,换算为对人类成人的给药量时,对人类成人给予0.0871mg/kg/day的菜蓟苦素。
(极小空间中的饲养)
通过在狭小空间(与常见的饲养空间相比,1/6尺寸的空间)中长期饲养小鼠,对小鼠诱导肌肉萎缩的实验方法(Br J Nutr.2020Nov 4;1-11.doi:10.1017/S0007114520004304.Online ahead of print.,URL:https://pubmed.ncbi.nlm.nih.gov/33143796/)。
进行该饲养4周后,测定小鼠的体重并在麻醉下从各组小鼠摘出比目鱼肌。测定该摘出的比目鱼肌的重量。
以下记载测定得到的结果。该测定是逐只测定各组(各10只)的比目鱼肌(左右的比目鱼肌)。以下测定得到的结果是各组的每1只的左右的比目鱼肌的合计量的平均值(g)。组4为0.01054545(g),组5为0.009945(g),组6为0.011722727(g),组7为0.01086(g)。该组6的值与该组4的值相比有显著差异(利用Tukey-Kramer法的检验,p<0.05),与该组5的值相比有显著差异(利用Tukey-Kramer法的检验,p<0.01)。
此外,算出小鼠的单位体重的比目鱼肌比例(g/kg),其结果,组4为0.022989716(g/kg),组5为0.021136972(g/kg),组6为0.023792774(g/kg),组7为0.021868527。该组6的值与该组5的值相比有显著差异(利用Tukey-Kramer法的检验,p<0.01)。
因此,在组6和组7中,与组5相比,能够确认到比目鱼肌的重量增加。
以上,参照附图对本发明的实施方式(也包含实施例)进行了说明,但本发明的具体结构不限于此,在不脱离本发明的主旨的范围内,即使进行了设计变更等,也包含于本发明中。
产业上的可利用性
通过本发明,能够提供用于人等的用于抑制肌肉萎缩的材料(制剂)等。
Claims (4)
1.一种用于抑制肌肉萎缩的制剂,其含有菜蓟苦素。
2.一种用于抑制肌肉萎缩的制剂,其含有洋蓟提取物。
3.一种口服组合物,其含有权利要求1或2所述的制剂。
4.根据权利要求3所述的口服组合物,其中,人类成人每日摄取0.01mg/kg/日~12.0mg/kg/日的菜蓟苦素。
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WO2004112819A1 (en) * | 2003-06-13 | 2004-12-29 | Gelstat Corporation | Compositions and methods of treatment comprising plant extracts |
JP2005194246A (ja) * | 2004-01-09 | 2005-07-21 | Ichimaru Pharcos Co Ltd | NF−κB活性化抑制剤 |
JP2006206532A (ja) * | 2005-01-31 | 2006-08-10 | Ichimaru Pharcos Co Ltd | NF−κB活性化抑制剤 |
US20070225315A1 (en) * | 2006-03-15 | 2007-09-27 | Theralogics, Inc. | Methods of Treating Muscular Wasting Diseases Using NF-kB Activation Inhibitors |
CN103597071A (zh) * | 2011-01-07 | 2014-02-19 | 埃尔舍利克斯治疗公司 | 基于化学感应受体配体的治疗 |
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WO2004112819A1 (en) * | 2003-06-13 | 2004-12-29 | Gelstat Corporation | Compositions and methods of treatment comprising plant extracts |
JP2005194246A (ja) * | 2004-01-09 | 2005-07-21 | Ichimaru Pharcos Co Ltd | NF−κB活性化抑制剤 |
JP2006206532A (ja) * | 2005-01-31 | 2006-08-10 | Ichimaru Pharcos Co Ltd | NF−κB活性化抑制剤 |
US20070225315A1 (en) * | 2006-03-15 | 2007-09-27 | Theralogics, Inc. | Methods of Treating Muscular Wasting Diseases Using NF-kB Activation Inhibitors |
CN103597071A (zh) * | 2011-01-07 | 2014-02-19 | 埃尔舍利克斯治疗公司 | 基于化学感应受体配体的治疗 |
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