CN113271947A - 心率降低剂 - Google Patents
心率降低剂 Download PDFInfo
- Publication number
- CN113271947A CN113271947A CN201980085369.8A CN201980085369A CN113271947A CN 113271947 A CN113271947 A CN 113271947A CN 201980085369 A CN201980085369 A CN 201980085369A CN 113271947 A CN113271947 A CN 113271947A
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- Prior art keywords
- heart rate
- exercise
- agent
- acid
- orotic acid
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Abstract
本发明的目的在于提供一种副作用更少的心率降低剂或新型的运动时的心率上升抑制剂。通过摄取含有乳清酸或其盐作为有效成分的制剂,能够降低心率,能够预防或改善特别是由心率亢进带来的心悸、气喘或疲劳感,进而能够抑制运动时的心率的上升。
Description
技术领域
本发明涉及含有乳清酸或其盐(以下,有时称为“乳清酸类”)作为有效成分的心率降低剂,由心率亢进造成的心悸、气喘或疲劳感的预防或改善剂,以及运动时的心率上升抑制剂。
背景技术
乳清酸(也称为卵白酸、尿嘧啶-6-羧酸、Orotic acid或维生素B13)是嘧啶核苷酸生物合成体系中的主要中间物质,从二氢乳清酸被二氢乳清酸脱氢酶诱导,通过乳清酸磷酸核糖基转移酶(PRPP)成为乳清苷酸。将乳清苷酸进而快速转变成尿苷一磷酸(UMP),然后合成尿苷三磷酸、胞苷三磷酸等嘧啶核苷酸。
近年来,关于乳清酸的生理作用的研究正在被推进。例如,已知乳清酸具有血中尿酸值降低作用(专利文献1),乳清酸具有耐力提高作用(专利文献2、3),乳清酸具有降低耗氧量和能量消耗量的作用(专利文献3),具有激活交感神经、改善困倦、使体温上升、促进脂肪分解或维持注意力的作用(专利文献4)等。
一方面,心率尽管是与血压、呼吸数、体温、意识一样重要的生命体征之一,但目前为止没怎么受到关注,而因为在心血管疾病的情况下心率越高则预后越不好,或者在心力衰竭或缺血性心脏病等中如果心率下降则预后改善,所以心率作为心血管疾病的重要的生物标志物之一受到关注。
另一方面,已知有作为活性成分含有2-[N-(2,6-二氯苯基)-N-丙烯胺]-2-咪唑啉或其酸加成盐的心率降低剂(专利文献5)。另外,还已知作为高血压或心房颤动患者的心率控制药而使用β受体阻滞剂。此外,已知有将动物酪蛋白水解得到的、包含游离氨基酸和肽的平均链长以氨基酸残基数计为2.1以下的酪蛋白水解物、或含有该水解物所含的游离氨基酸和肽混合物作为有效成分的口服给药用的运动时的心率上升抑制组合物(专利文献6)。
现有技术文献
专利文献
专利文献1:日本特开2011-98896号公报
专利文献2:日本特开2011-136907号公报
专利文献3:日本特开2012-246280号公报
专利文献4:日本特开2012-126683号公报
专利文献5:日本特开昭55-15481号公报
专利文献6:国际公开2016-182053号公报
发明内容
本发明要解决的技术问题
目前被广泛使用的β受体阻滞剂虽然降低心率的效果较大,但是副作用也强,在其使用时需要观察给药的患者的状态而慎重地进行。另外,作为运动时的心率上升抑制剂,仅知道专利文献6中记载的天然物的水解物,有难以调整其组成的问题。本发明鉴于这样的情况,目的是提供副作用更小的心率降低剂或新型的运动时的心率上升抑制剂。
用于解决技术问题的方案
本发明的发明人为了解决上述技术问题深入进行了研究,结果发现,激活交感神经的乳清酸类对于心脏具有使其心率降低的作用,并且在运动时通常心率上升而感到运动费力的情况下,通过服用乳清酸类,心率的上升被抑制,也能够轻松地进行运动,从而完成了本发明。
即,本发明是通过以下的事项规定的如下发明。
(1)一种心率降低剂,含有乳清酸或其盐作为有效成分。
(2)一种由心率亢进造成的心悸、气喘或疲劳感的预防或改善剂,含有乳清酸或其盐作为有效成分。
(3)上述(2)所述的由心率亢进造成的心悸、气喘或疲劳感的预防或改善剂,由心率亢进造成的心悸或气喘是由于运动、老龄化、心肺功能的下降或饮酒而发生的。
(4)一种运动时的心率上升抑制剂,以乳清酸或其盐为有效成分。
(5)上述(1)~(4)中任一项所述的药剂,其为口腔内给药。
作为本发明的其他方式能够列举以下内容。
(6)一种心率的降低方法,对对象给药乳清酸或其盐的有效量。
(7)一种乳清酸或其盐,用于降低心率。
(8)乳清酸或其盐在用于制造心率降低剂中的用途。
(9)一种由心率亢进造成的心悸、气喘或疲劳感的预防或改善方法,对对象给药乳清酸或其盐的有效量。
(10)一种乳清酸或其盐,用于由心率亢进造成的心悸、气喘或疲劳感的预防或改善。
(11)乳清酸或其盐在用于制造由心率亢进造成的心悸、气喘或疲劳感的预防或改善剂中的用途。
(12)一种运动时的心率的上升抑制方法,对对象给药乳清酸或其盐的有效量。
(13)一种乳清酸或其盐,用于抑制运动时的心率的上升。
(14)乳清酸或其盐在用于制造运动时的心率上升抑制剂中的用途。
(15)上述(1)所述的心率降低剂、上述(2)所述的由心率亢进造成的心悸、气喘或疲劳感的、预防或改善剂、或者上述(4)所述的心率上升抑制剂的给药方法,在口腔内给药。
(16)一种乳清酸或其盐,用于将上述(1)所述的心率降低剂、上述(2)所述的由心率亢进造成的心悸、气喘或疲劳感的、预防或改善剂、或者上述(4)所述的心率上升抑制剂在口腔内给药。
(17)乳清酸或其盐在用于制造上述(1)所述的心率降低剂、上述(2)所述的由心率亢进造成的心悸、气喘或疲劳感的、预防或改善剂、或者上述(4)所述的心率上升抑制剂作为口腔内给药剂中的用途。
发明效果
通过使用本发明的心率降低剂,能够安全且高效地降低心率,能够实现心力衰竭和缺血性心疾病的预后的改善。
通过使用本发明的由心率亢进造成的心悸、气喘或疲劳感的预防或改善剂,能够使得由运动、老龄化、心肺功能的下降、饮酒等发生的心悸、气喘、疲劳感等不发生、或减轻症状的发作、或者能够改善这样的症状。
另外,通过使用本发明的运动时的心率上升抑制剂,在运动时心率上升通常感到运动费力的情况下,心率的上升被抑制,也能够继续轻松地运动。
另外,心率由自主神经的平衡来调整,心率的降低一般是副交感神经发挥主导作用时发生的现象,因此对于副交感神经占主导地位时发生的其他现象、例如胃酸、唾液分泌的促进、肠蠕动的促进、睡眠诱导等也可以期待效果,有可能能够作为消化剂、便秘药、睡眠诱导剂等发挥效果。
另外,对于压力或紧张等交感神经占主导地位的症状的缓和也有可能有效。
附图说明
图1表示将每天到运动俱乐部的低氧室锻炼的12人作为受试者,测定摄取乳清酸后进行锻炼时的心率的结果(实施例2)。此外,为了比较,还测定了在上述锻炼时的1周前、1周后不摄取乳清酸而进行锻炼时的心率,将其结果也一并表示。在纵轴表示心率,在横轴表示摄取乳清酸而进行锻炼的试验时、其1周前、其1周后的不摄取乳清酸而进行的锻炼时。另外,心率是12名受试者的平均值。
图2表示将马拉松运动员的30多岁男性作为受试者,测定不摄取乳清酸而进行练习跑步时的心率的随时间变化的结果(实施例3的比较例)。
图3是表示将马拉松运动员30多岁的男性作为受试者,测定摄取乳清酸而进行全程马拉松时的心率的随时间变化的结果(实施例3)。
图4是表示将马拉松运动员20多岁的男性作为受试者,测定不摄取乳清酸非摄取而进行30km跑时的心率的随时间变化的结果(实施例4的比较例)。
图5是表示将马拉松运动员20多岁的男性作为受试者,测定在摄取乳清酸后进行全程马拉松时的心率的随时间变化的结果(实施例4)。
图6是表示将马拉松运动员20多岁的男性作为受试者,测定不摄取乳清酸而进行半程马拉松时的心率的随时间变化的结果(实施例5的比较例)。
图7是表示将马拉松运动员20多岁的男性作为受试者,测定在摄取乳清酸后进行全程马拉松时的心率的随时间变化的结果(实施例5)。
具体实施方式
作为本发明的心率降低剂,由心率亢进造成的心悸、气喘或疲劳感的预防或改善剂,或者运动时的心率上升抑制剂(以下,称为“心率降低剂等”),只要是含有乳清酸或其盐作为有效成分的药剂就可以,没有特别限制。上述乳清酸也被称为尿嘧啶-6-羧酸,但根据IUPAC命名法,是用“1,2,3,6-四氢-2,6-二氧代-4-嘧啶羧酸”表示的芳香杂环化合物的一种。此外,在本发明中所述的心率降低剂,除了降低心率的药剂以外,还包括如果不摄取上述药剂则心率上升、而在摄取了上述药剂的情况下能够抑制其上升(维持现状)或减少上升(虽然上升,但比不摄取时的上升量要减小)的药剂。
另外,在本发明中所述的运动时的心率上升抑制剂,是相比于不摄取该药剂而进行运动的情况下的平常时的心率的增加量、能够减小摄取该剂而进行运动的情况下的从平常时的心率的增加量的药剂。
上述乳清酸例如可以通过培养具有乳清酸生产能力的棒状杆菌属细菌、在培养物中生产并积累乳清酸、将其收集的制造方法(参照日本特公平7-10235号)等使用微生物的发酵法,在培养液中生成并积累;从上述培养物通过利用已经公知的通常的提纯手段,例如沉淀法、利用离子交换树脂或活性炭等的色谱法等分离提纯法,能够提纯、收集。另外,也可以利用公知的化学合成法等制备。进而也可以使用市售品
作为乳清酸类,可以列举乳清酸自由体(游离体)或乳清酸的盐,优选为乳清酸自由体(游离体)。
作为乳清酸的盐,例如可以列举酸加成盐、金属盐、铵盐、有机胺加成盐、氨基酸加成盐等。作为酸加成盐,可以列举盐酸盐、硫酸盐、硝酸盐、磷酸盐等的无机酸盐,乙酸盐、马来酸盐、富马酸盐、柠檬酸盐、苹果酸盐、乳酸盐、α-酮戊二酸盐、葡萄糖酸盐、辛酸盐等的有机酸盐。作为金属盐,可以列举钠盐、钾盐等的碱金属盐,镁盐、钙盐等的碱土金属盐,铝盐、锌盐等。作为铵盐,可以列举铵、四甲基铵等的盐。作为有机胺加成盐,可以列举三乙胺、吡啶、吗啉、哌啶等的盐。作为氨基酸加成盐,可以列举甘氨酸、苯丙氨酸、赖氨酸、天冬氨酸、谷氨酸等的盐。
作为本发明的心率降低剂等,虽然也可以将乳清酸或其盐原样给药,但优选的是根据需要与载体等一起混合、以医药品或饮食品/辅食的各种组合物的形式提供。
作为被作为上述医药品提供的乳清酸的盐,只要是在医药学上被容许的盐即可,没有特别限定,可以列举在将乳清酸盐溶解于水的情况下水溶液呈现中性至弱酸性、在保存中沉淀或析出的可能性较小的胆碱盐、赖氨酸盐、精氨酸盐、鸟氨酸盐,在饮料的情况下,这些水溶性的盐是优选的。另外,在作为胶囊或片剂摄取的情况下,由于不需要为水溶性,所以可以列举难溶性的钠盐、钾盐、镁盐、钙盐、铵盐等的金属盐。另外,乳清酸能够与肉毒碱形成盐而可溶化,肉毒碱盐(L-肉毒碱乳清酸盐)虽然溶解性较好,但由于水溶液为低pH,所以根据需要可以通过添加鸟苷等的嘌呤碱基或碱性氨基酸使pH成为弱酸性来使用。
在将本发明的心率降低剂等作为医药品提供的情况下,可以将乳清酸或其盐以其原样,或使用在医药上被容许且根据剂型适当选择的适当的添加剂(例如载体、赋形剂、稀释剂、结合剂、润滑剂、崩解剂或崩解助剂、增溶剂、稳定剂、保存剂、防腐剂、抗氧化剂、细菌抑制剂、增量剂、增粘剂、乳化剂、分散剂、悬浮剂、缓冲剂等),通过公知的各种方法制备成能够口服或非口服地全身或局部给药的各种制剂形态。
例如,在为适合于口服给药的糖浆剂等液体调制物的情况下,可以添加水、蔗糖、山梨糖醇、果糖等糖类,聚乙二醇、丙二醇等的二醇类,芝麻油、橄榄油、大豆油等油类,对羟基苯甲酸酯类等防腐剂,草莓香料、薄荷香料等的香料类等,进行制剂化。
另外,在适合于口服给药的片剂、散剂、颗粒剂等的情况下,可以添加乳糖、白糖、葡萄糖、蔗糖、甘露醇、山梨糖醇等的糖类,马铃薯、小麦、玉米等的淀粉,碳酸钙、硫酸钙、碳酸氢钠、氯化钠等的无机物,甘草粉末、龙胆末等的植物粉末等的赋形剂;淀粉、琼脂、明胶粉末、结晶纤维素、羧甲基纤维素钠、羧甲基纤维素钙、碳酸钙、碳酸氢钠、藻酸钠等的崩解剂;硬脂酸镁、滑石、氢化植物油、聚乙二醇、硅油等的润滑剂;聚乙烯醇、羟丙基纤维素、甲基纤维素、乙基纤维素、羧甲基纤维素、明胶、淀粉糊等的结合剂;脂肪酸酯等的表面活性剂;甘油等的增塑剂等,进行制剂化。
另外,在适合于口服给药的制剂中,也可以添加一般在饮食品中使用的添加剂,例如甜味料、着色剂、保存料、增粘稳定剂、抗氧化剂、发色剂、漂白剂、防霉剂、胶基、苦味料、酵素、光泽剂、酸味料、调味料、乳化剂、增韧剂、制造用剂、香料、香辛料提取物等。
制剂的给药方式可以列举口服给药,或者静脉内、腹膜内或皮下给药等的非口服给药,更优选的是口服给药。作为给药的剂型,例如可以是片剂、散剂、颗粒剂、丸剂、悬浊剂、乳剂、浸剂/汤剂、胶囊剂、糖浆剂、液剂、酏剂、浸膏、酊剂、流浸膏等的口服剂,注射剂(例如皮下注射剂、静脉内注射剂、肌肉内注射剂、腹腔内注射剂)、点滴剂、栓剂(例如直肠栓剂、阴道栓剂)、吸入剂、经皮/经粘膜吸收剂、软膏剂、贴剂等的非口服剂的任意一种,更优选的是口服剂,其中优选的是口腔内给药剂。
作为口腔内给药的部位,可以列举嘴唇、可动口腔粘膜、非可动口腔粘膜、牙齿等。
嘴唇被分为上唇和下唇,是包围口腔的开口部的部位。可动口腔粘膜是通过体性神经而可动的口腔内的粘膜,例如包括嘴唇~鼻唇沟或嘴唇~颏隆起的里侧的粘膜、颊粘膜、舌等。
另外,非可动口腔粘膜是不能通过体性神经活动的被固定的口腔内的粘膜,例如包括齿龈、硬腭或软腭的粘膜、口腔底部的粘膜等。
另外,牙齿是植在颌上的硬质的构造物,主要在进食时发挥重要的作用。
在将本发明的心率降低剂等作为口腔内给药剂制剂化时,可以制成公知的溶液剂、悬浮剂、乳浊剂、颗粒剂、细粒剂、散剂或凝胶剂等的含漱用制剂;软膏剂、霜剂、凝胶剂、粘稠剂、粘着剂、颗粒剂、细粒剂或散剂等的涂布用制剂;带剂、巴布剂、膜剂等的贴附用制剂;外用气溶胶喷雾剂、泵喷雾剂等的喷雾剂;含剂、片剂、颊剂、舌下剂或咀嚼剂等有效成分在口腔内的嘴唇、可动口腔粘膜、非可动口腔粘膜或牙齿上持续比较长时间滞留的剂型。
关于溶液剂、悬浊剂、乳浊剂、霜剂、凝胶剂、粘稠剂,为以水、能够与水以无限制的比率混合的水系溶剂以及它们的混合溶剂为连续层的剂型,有外观透明的情况和半透明或不透明的情况。通常具有流动性,但霜剂或粘稠剂、凝胶剂的一部分也包括具有保形性的情况。这些药剂可以使用公知的成分制备,作为这样的成分,例如可以列举:N-酰基氨基酸盐、N-酰基牛磺酸盐、烷基硫酸酯盐等的阴离子表面活性剂,咪唑啉系两性表面活性剂、甜菜碱系表面活性剂等的两性表面活性剂,山梨糖醇酐系表面活性剂、甘油脂肪酸酯、聚甘油脂肪酸酯、丙二醇脂肪酸酯、烷基糖苷、吐温系表面活性剂、聚氧乙烯甘油脂肪酸酯、聚氧乙烯聚甘油脂肪酸酯、聚氧乙烯丙二醇脂肪酸酯、聚氧乙烯氢化蓖麻油衍生物、蔗糖脂肪酸酯、聚氧乙烯烷基醚、普兰尼克(Pluronic)型表面活性剂、烷醇酰胺等的非离子表面活性剂,卵磷脂、皂苷等的存在于自然界中的表面活性剂等的表面活性剂;植物油、动物油、氢化油等的油脂类;液体石蜡、角鲨烷、凡士林等的烃油;月桂酸、硬脂酸、油酸等的高级脂肪酸;蜂蜡、羊毛脂及其衍生物等的蜡类;单烷基脂肪酸酯类;多元醇脂肪酸酯类;乙醇、丁醇等的低级醇;月桂醇、硬脂醇、山萮醇、鲨肝醇等的高级醇;羊毛醇、胆固醇、植物甾醇等的其他醇等醇类;乙二醇、丙二醇、甘油等的多元醇类;二丙二醇、二甘油、聚甘油等的多元醇聚合物类;山梨糖醇、麦芽糖醇、甘露糖醇、赤藓醇等的糖醇类;硫酸软骨素、透明质酸、肝素等的粘多糖类;乳酸钠、吡咯烷酮羧酸盐、胶原蛋白类等的有机化合物;植物提取物等的保湿剂;羟乙基纤维素、羟丙基纤维素、羧甲基纤维素、羟乙基羧甲基纤维素等的纤维素衍生物,阿拉伯胶、角叉菜胶、黄蓍胶、刺梧桐树胶、阿拉伯树胶、瓜尔胶、琼脂、海藻酸类、胶原蛋白水解物、明胶、酪朊蛋白质等的天然系高分子类;结冷胶、黄原胶等的微生物产生高分子类;聚乙烯醇、聚丙烯酸钠、羧基乙烯基聚合物、聚乙烯吡咯烷酮等的合成系高分子类;硬脂酸铝凝胶、无水硅酸、磷酸钙、碳酸钙等的无机系增稠剂等增粘剂(也包括凝胶化剂)或分散剂等;除此以外,还可以配合:茴香脑、丁香酚、水杨酸甲酯、柠檬烯、罗勒烯、正癸醇、香茅醇、α-松油醇、乙酸甲酯、香茅醇乙酸酯、甲基丁香酚、桉树脑、芳樟醇、乙基芳樟醇、百里酚、柠檬油、橙油、鼠尾草油、迷迭香油、桂皮油、紫苏油、冬青油、丁香油、桉树油、多香果油、d-樟脑、d-冰片、茴香油、肉桂油、肉桂醛、薄荷油、香草醛等的香料;糖精钠、乙酰磺胺酸钾、甜菊苷、新橙皮苷二氢查耳酮、紫苏亭、索马甜、阿斯巴甜、对甲氧基肉桂醛等的甜味剂;对羟基苯甲酸酯类、苯甲酸钠、苯氧基乙醇、盐酸烷基二氨基乙基甘氨酸等的防腐剂;蓝色1号、黄色4号、红色202号、绿3号等的法定色素,群青、强化群青、普鲁士蓝等的矿物类色素,氧化钛等的着色剂(包含浊剂);柠檬酸、磷酸、苹果酸、焦磷酸、乳酸、酒石酸、甘油磷酸、醋酸、硝酸、它们的在化学上可能的盐、氢氧化钠等的p H调节剂;根据需要,其他药效成分等。
关于颗粒剂、细粒剂和散剂,为粉状的固形剂,关于含剂、片剂、颊剂和舌下剂,为块状的固形剂。上述的颗粒剂、细粒剂和散剂可以通过单单将粉末形状的物质混合、或通过借助造粒工序等制成规定的粒度来制备。也可以通过借助喷雾干燥等使上述的溶液剂、分散剂、悬浊剂等干燥来制备。在这些剂型的制备时,根据需要而配合赋形剂、崩解剂、结合剂等。另外,由于是使其在口中溶解而使用,所以根据需要可以配合甜味剂、矫味料或香味料。作为赋形剂,例如可以列举白糖、乳糖、甘露醇、结晶纤维素、淀粉、海藻酸、磷酸钙、碳酸钙等;作为崩解剂,可以举出羧甲基纤维素、羧甲基纤维素钙、结晶纤维素等的纤维素衍生物,淀粉等;作为结合剂,可以列举羟丙基纤维素、甲基纤维素等的纤维素衍生物,刺槐,明胶,糊精,聚乙烯吡咯烷酮等。另外,关于含剂、片剂、颊剂和舌下剂,可以使用将粉状原料混合并进行造粒加工而制备的产物,或用与上述的颗粒剂、细粒剂或散剂同样的方法制备得到的产物,通过成型为规定的形状来制备。只要为不妨碍口中的咀嚼及溶解使用的范围,也可以在成型后对成型物的表面进行包衣处理。
关于软膏剂,可以通过与羊毛脂类、塑料基体、白色凡士林、石蜡、蜂蜡类、吸水软膏、聚乙二醇、丙二醇、甘油、硬脂醇、硬脂酸、甘油明胶、植物油、可可脂等混合来制备。
关于带剂、巴布剂,是由支撑体和涂布体等构成的片状的剂型。可以使用在带剂或巴布剂中使用的物质作为支撑体,但由于在口中使用,所以优选的是选择在使用中通过溶解、或分解/分散而形状最终消失的物质,作为这样的物质,例如可以列举聚丙烯酸、羟丙基纤维素、羟丙甲纤维素邻苯二甲酸酯等。
本发明的心率降低剂虽然其作用机理尚不明确,但由于能够不妨碍心房的其他功能而降低心率,所以对因心动过速性心房颤动造成的心悸或气喘等的症状的改善、心力衰竭或心动过速诱发的心肌病的预防、慢性心力衰竭的预后的改善和QOL的改善、高血压症的治疗、因心肌缺血造成的症状的控制、急性心肌梗塞或死亡之类的重大的心血管事件的预防等是有效的,特别是作为因通过运动、年龄增长、心肺功能下降、饮酒等发生的心率亢进造成的心悸、气喘或疲劳感的预防及或改善剂是有效的。
“心率的亢进”,表示在比较某个时刻和之后的某个时刻的情况下、相比于某个时刻的心率之后的某个时刻的心率增加的情况,是相对的概念,具体而言可以例示:如果是由运动造成的,则是运动后比运动前的心率增加的情况,如果是由年龄增长造成的,则是相同状态下的心率相比于过去、从过去经过一段时间后的时刻的心率增加的情况,如果是由心肺功能下降造成的,则是在心肺功能比以前下降的情况下、心肺功能下降的时刻的心率相比于以前增加的情况,如果是饮酒造成的,则是相比于饮酒前、饮酒后的心率增加的情况等。
本发明的运动时的心率上升抑制剂,是在走路、慢跑、跑步、马拉松、游泳、自行车骑行、有氧操、赛艇、棒球、网球、乒乓球、足球、篮球、排球、舞蹈、射箭、自行车骑行、自行车比赛、滑雪、滑冰、滑板、徒步、登山、潜水、跳伞、摩托车、自行车比赛等的运动时或竞技时,抑制伴随着因运动带来的对于身体的负荷的心率上升的药剂。
作为服用上述抑制剂的对象者,是以健康增进、生活习惯病的预防、改善为目的或因兴趣而致力于运动的人(以下称为“一般运动者”)或被称为运动员的竞技运动者。另外,在一般运动者中,还包括尽管在当前时间点没有特别以运动为习惯、但想要以运动为习惯或认为应以运动为习惯的潜在运动诉求者(以下称为“运动预备人群”)。
作为表示运动时的身体负荷的指标,有运动强度,例如可以由利用心率的下述卡沃南氏公式(Karvonen Formula)求出。
运动强度(%)=(运动时的心率-安静时心率)÷(最大心率-安静时心率)×100
最大心率也可以个别地测定,但可以通过下述式子作为估计值求出。
最大心率=220-年龄
另外,在高龄者的情况下也可以通过以下的式子求出。
最大心率(高龄者用)=207-(年龄×0.7)
上述运动强度在0%时为安静时,在低于20%时为微轻度,在20%~39%时为轻度,在40%~59%时为中等度,在60%~84%时为强度,在85%以上时为极强度(参照庆应义塾大学体育医学研究中心纪要,p33-39,1999年)。
若将其主观地表现,则低于40%时为轻松的运动,40%以上且小于80%时为从稍微费力的运动到非常费力的运动,80%以上表示接近极限的运动。
在一般运动者或运动预备人群中,伴随着运动时的心率的上升的痛苦有时会成为持续进行运动的障碍。特别越是高龄者,相对于脉搏数的增加的运动强度的敏感性越高,在较低心率下也会感到运动费力(参照关于运动基准/运动指南的修改的研讨会报告书,平成25年3月,日本厚生劳动省)。因而,通过在运动前服用本发明的运动时的心率上升抑制剂,在一般运动者的情况下,即使为高龄,也能够轻松地继续维持运动习惯,在运动预备人群的情况下,成为新或再次进行运动的契机。
另外,对于需要康复训练的人而言,通过在康复训练前服用本发明的运动时的心率上升抑制剂,能够减轻伴随着因康复训练时的身体负荷带来的心率上升的痛苦。
对于竞技者而言,特别是在长时间因身体负荷而心率上升的状态持续那样的竞技的情况下,如果能够抑制其上升的程度,则有可能带来耐力的提高。
作为摄取本发明的运动时的心率上升抑制剂的情况下的运动强度,没有特别限制,只要是超过0%的运动强度即可,特别优选为在80%以下的运动强度的运动时摄取,更优选为在60%以下的运动强度的运动时摄取,更加优选为在10%~40%的运动强度的运动时摄取。
另外,对于运动时间没有特别限制,对从几秒至几小时的运动都能够应用本发明的运动时的心率上升抑制剂,但优选地适合用于至少持续进行5分钟~10分钟左右的运动。
本发明的心率降低剂等优选的是定期摄取,但在进行预测会有心率亢进的运动、饮酒等的情况下,优选的是在其3小时前以内摄取,更优选的是在2小时前以内摄取。
另外,在进行30分钟以上、优选的是1小时以上的运动的情况下,不仅是在运动前摄取,在运动中也可以摄取,在运动结束后也可以摄取。
作为将本发明的心率降低剂等作为医药品使用的情况下的给药量,可以根据给药对象的年龄、性别、体重、症状的程度或给药方法等适当确定,通常成人每1天,以1天1次到几次作为乳清酸或其盐而给药10mg~10g、优选为50mg~5g、更优选为100mg~1g的量。
在将本发明的心率降低剂等作为医药品提供的情况下,作为有效成分的乳清酸或其盐的含量可以根据医药品的种类或通过该医药品的给药所期待的效果等适当选择,通常为0.01~100质量%,优选为0.05~100质量%,更优选为0.1~100质量%。
本发明的心率降低剂等还可以作为饮食品或辅食的添加剂添加到饮食品或辅食中。在此情况下,添加量只要考虑对象饮食品或辅食的一般的摄取量、饮食品的形态、效能/效果、呈味性、嗜好性和成本等适当设定即可,以通常作为有效成分的乳清酸或其盐在饮食品或辅食中的含量为0.01~100质量%、优选为0.05~100质量%、更优选为0.1~100质量%的方式添加。
在将本发明的心率降低剂等用作饮食品或辅食的添加剂的情况下,只要不损害本发明的效果,作为其他成分也可以含有各种蛋白质、糖类、脂肪、微量元素、维生素类、柠檬酸或乙酸等有机酸盐等。另外,根据添加的饮食品或辅食的种类,也可以含有在饮食品或辅食中被容许、通常使用的添加剂,例如除了阿斯巴甜、甜菊糖等的甜味料,柠檬酸、苹果酸、酒石酸等的酸味剂,糊精、淀粉等的赋形剂以外,还有着色剂、香料、苦味料、缓冲剂、增粘稳定剂、胶化剂、稳定剂、胶基、结合剂、稀释剂、乳化剂、分散剂、悬浮剂、抗氧化剂、防腐剂、防腐剂、防霉剂、发色剂、漂白剂、光泽剂、酵素、调味料、香辛料提取物等。
作为本发明的心率降低剂等的添加对象的饮食品,可以列举茶饮料、啤酒类饮料、咖啡、矿泉水、乳饮料等的饮料(包括这些饮料的浓缩原液以及调制用粉末);饭类、面类、面包类以及意大利面类等的含糖类产品;饼干及蛋糕等的西点类、馒头及羊羹等日本点心类、糖果类、口香糖类、布丁、果冻等的冷冻点心、冰点点心等的各种点心类;鱼糕、竹轮、汉堡、火腿、香肠等的水产/畜产加工食品;加工乳、发酵乳、酸奶、黄油、奶酪等的乳制品;人造黄油、蛋黄酱、起酥油、搅打奶油、调味汁(dressing)等的油脂以及油脂加工食品;沙司、佐料等的调味料等。
作为本发明的心率降低剂等的添加对象的辅食,只要是被称为功能性食品、营养辅助食品、健康辅助食品、营养强化食品、营养调节食品等的所谓的健康食品者即可,没有特别限制,例如可列举补充身体所需要的维生素(例如维生素B1、维生素B2、复合维生素等)、矿物质(例如铁、锌等)、氨基酸或食物纤维、补充DHA、EPA等的基础辅食,含有异黄酮、蜂王浆、蜂胶、芝麻素、儿茶素等的用于维持健康或美容等的健康辅食,含有姜黄、玛咖、蓝莓、葡萄糖胺等的用于健康状态恢复的可选辅食等。
添加本发明的心率降低剂等而成的饮食品或辅食的形状只要是哺乳动物能够摄取且适于食用的形状即可,没有特别限制,例如可以列举固形状、液状、半液体状、颗粒状、粒状、粉末状、胶囊状、霜状、糊状、啫喱状等。
此外,添加本发明的心率降低剂等而成的饮食品包括健康食品、功能性食品、特定保健用食品、营养辅助食品、病人用食品。其中,优选作为适于期待由于心率降低而心动过速性心房颤动造成的心悸/气喘等症状的改善、心力衰竭/心动过速诱发的心肌病的预防、慢性心力衰竭的预后的改善和QOL的改善、高血压症的治疗、因心肌缺血引起的症状的控制、急性心肌梗塞或死亡之类的重大的心血管事件的预防等的消费者的食品、即特定保健用食品来提供。
另外,本发明的心率降低剂等可以作为发酵食品的原材料使用。
添加本发明的心率降低剂等而成的饮食品或辅食的摄取量只要是能够发挥心率降低作用的量即可,没有特别限定,通常,成人每1天的摄取量以乳清酸或其盐计,可以列举10mg~10g、优选为50mg~5g、更优选为100mg~1g的量。
实施例
以下,通过实施例进一步具体地说明本发明,但这些实施例并不限定本发明。
实施例1
口服摄取含有乳清酸的片剂,在口服摄取前和口服摄取后测定心率的变化。受试者为62岁的男性,在健康诊断中被指出胆固醇偏高,但没有服用药也没有既往病史,血压是正常值的范围,过去对于血压没有诊断出有问题。心率为89~92/分钟左右稍高,在安静时心率也几乎都不低于86/分钟。
由于心率会因运动或紧张等而立即上升,所以测定日尽可能以做桌案工作等度过,就座于椅子几分钟以上,在安定的状态下测定。
每天饮用啤酒2罐、双份烧酒2~3杯,饮酒后的心率上升至105~115/分钟左右(偶尔到120/分钟),感到醉意和轻微心悸。某天也会感到困倦。
使受试者的男性以口腔内给药摄取含有乳清酸200mg的片剂,开始测定心率。从乳清酸摄取后2小时左右起,心率逐渐降低,4小时后成为80/分钟以下,成为约70/分钟~80/分钟前半的稳定的心率。与乳清酸摄取前的状态比较,在摄取后的心率降低状态下,是头脑很清醒的感受,不再有总是感到的倦怠感。
在心率降低后饮用像往常一样的量的啤酒、烧酒,但心率也仅上升至90~100/分钟前半左右,与平时不同,基本没有感到醉意和心悸。
将以上的结果汇总表示于表1。
[表1]
根据表1的结果,通过摄取乳清酸,明显观测到心率的降低,由此,日常感到的心悸、疲劳感也得到改善。
实施例2
将每天去运动俱乐部的低氧室锻炼的12人作为受试者,验证乳清酸的锻炼中的心率的降低效果。
各受试者在锻炼2小时前使含乳清酸200mg的咀嚼片2片在口腔内溶解来摄取。
各人的运动强度以达到最大心率的30%+20bpm程度的心率的方式来设定。运动强度通过上述卡沃南氏公式求出。该运动强度相当于主观运动强度(博格指数,Borg scale)的11~13,是接近于有氧阈值的值。
各被检者每10分钟测定心率,合计进行40分钟运动。
此外,为了比较,在进行上述试验之前的周、进行上述试验之后的周,与上述试验同样地测定不摄取乳清酸而进行与上述试验同样的运动时的心率。将其结果表示于图1。
图1的纵轴表示心率。另外,心率的值表示12名受试者的平均值。
根据图1可知,在摄取乳清酸而运动时(试验),与不摄取时(前一周和2周后)相比,确认了心率的降低。
另外,在试验后,向各受试者进行了用10个等级评价来表示与不摄取乳清酸的通常的运动相比是费力还是轻松的调查问卷。将其结果表示于表2。另外,在10等级评价中,5表示与通常相比没有变化,越大于5表示比通常越轻松,越小于5表示比通常越费力。
[表2]
评价等级 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 |
回答数 | 1 | 2 | 5 | 3 | 1 |
根据表2,许多人实际感到了通过摄取乳清酸能够比通常更轻松地运动。
实施例3
以马拉松运动员的30多岁男性为受试者,验证马拉松中的心率降低效果。
受试者作为练习跑步,在不摄取乳清酸的状态下,以平均步速4分44秒/km跑52分50秒,用佳明(Garmin)的带GPS的运动量计测定该期间的心率。将其结果表示于表3和图2。
[表3]
合计时间(比率) | |
心率区间5(心率169以上) | 18分55秒(36%) |
心率区间4(150~168) | 22分40秒(43%) |
其以下(132~149) | 10分54秒(20%) |
在马拉松比赛(全程马拉松)当日,在开始的1小时前使含有乳清酸200mg的咀嚼片2片在口腔内溶解而摄取。然后,参加比赛,以平均步速4分48秒/km、3小时24分33秒完成跑步,同样测定其间的心率。将其结果表示于表4和图3。
[表4]
合计时间(比率) | |
心率区间5(心率169以上) | 23分55秒(12%) |
心率区间4(150~168) | 2小时54分0秒(85%) |
其以下(~149) | 6分7秒(3%) |
根据表3和表4可知,马拉松时和练习时的平均步速基本相同,尽管马拉松时的距离长时间长,但通过乳清酸的摄取,跑步中的心率明显降低。
另外,根据图2和图3,心率以整体平均看为162和161,但在不摄取乳清酸的练习跑步中,在50分钟以内脉搏数超过170,相对于此,在摄取乳清酸的马拉松中,脉搏数超过160是80分钟以后,心率的上升明显被抑制。
实施例4
以马拉松运动员的20多岁男性为受试者,验证马拉松中的心率降低效果。
天气晴朗,在气温16℃下,以平均步速4分12秒/km进行30km的练习跑步,与实施例3同样地测定其间的心率。将其结果表示于表5和图4。练习跑步时的平均心率为158,最高心率为176。
[表5]
合计时间(比率) | |
心率区间5(心率160以上) | 50分48秒(41%) |
心率区间4(143~160) | 1小时11分52秒(85%) |
其以下(~142) | 1分30秒(1%) |
在马拉松比赛(全程马拉松)当日,在开始1小时前使含有乳清酸200mg的咀嚼片2片在口腔内溶解而摄取。然后,参加比赛,以平均步速4分6秒/km、2小时58分18秒完成跑步,同样地测定其间的心率。将其结果表示于表6和图5。此外,比赛当日的气象条件是天气晴朗、气温19℃,是与练习跑步时大致相同的条件。比赛时的平均心率为155,最高心率为168。
[表6]
合计时间(比率) | |
心率区间4(心率165以上) | 0分32秒(0%) |
心率区间3(144~164) | 2小时54分21秒(98%) |
心率区间2(124~143) | 3分25秒(2%) |
练习跑步时的平均步伐为4分12秒/km,虽然是与马拉松比赛时的平均步速4分6秒/km大致相同的步速,但在没有摄取乳清酸的情况下,心率整体的41%是心率区间5(160~)以上,相对于此,在摄取了乳清酸的情况下,98%是区间3(144~164),在后半程也没有看到心率增加的漂移现象,可以确认在摄取乳清酸的情况和不摄取乳清酸的情况下在心率上有较大的差异。
实施例5
以马拉松运动员的20多岁男性为受试者,验证马拉松中的心率降低效果。
受试者在没有摄取乳清酸的状态下,以平均步速2分49秒/km、59分33秒跑完半程马拉松,用佳明的带有GPS的运动量计测定其间的心率。将其结果表示于表7和图6。
[表7]
合计时间(比率) | |
心率区间5(心率169以上) | 0分14秒(0%) |
心率区间4(150~168) | 29分38秒(49%) |
心率区间3(132~149) | 27分42秒(46%) |
心率区间2(113~131) | 1分45秒(3%) |
心率区间1(94~112) | 0分14秒(0%) |
在马拉松比赛(全程马拉松)当日,在开始1小时前使含有乳清酸200mg的咀嚼片2片在口腔内溶解而摄取。然后,参加比赛,以平均步速3分17秒/km、2小时18分37秒完成跑步,同样测定其间的心率。将其结果表示于表8和图7。
[表8]
合计时间(比率) | |
心率区间5(心率169以上) | 1分14秒(1%) |
心率区间4(150~168) | 31分15秒(49%) |
心率区间3(132~149) | 1小时33分59秒(68%) |
心率区间2(113~131) | 11分08秒(8%) |
心率区间1(94~112) | 0分26秒(0%) |
在全程马拉松和半程马拉松中,由于平均步速不同所以不能简单进行比较,但根据图6和图7可知,相比于没有摄取乳清酸的半程马拉松,摄取乳清酸的全程马拉松的平均心率被抑制得较低。
产业上的可利用性
通过使用本发明的药剂,不仅能够期待心悸气喘的减轻和心肺功能的负担减轻,而且能够期待放松效果、抗压效果等,作为能够改善QOL的安全的药剂,在医疗领域、辅食等的健康食品领域有用。另外,由于能够抑制运动时的心率的上升,所以作为面向一般运动者或面向竞技者的辅食在体育领域也有用。
Claims (5)
1.一种心率降低剂,含有乳清酸或其盐作为有效成分。
2.一种由心率亢进造成的心悸、气喘或疲劳感的预防或改善剂,含有乳清酸或其盐作为有效成分。
3.如权利要求2所述的由心率亢进造成的心悸、气喘或疲劳感的预防或改善剂,由心率亢进造成的心悸或气喘是由于运动、老龄化、心肺功能下降或饮酒而发生的。
4.一种运动时的心率上升抑制剂,以乳清酸或其盐为有效成分。
5.如权利要求1~4中任一项所述的剂,为口腔内给药。
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DE2831190A1 (de) | 1978-07-15 | 1980-01-24 | Boehringer Sohn Ingelheim | Verwendung von 2-eckige klammer auf n-(2,6-dichlorphenyl)-n-allyl-amino eckige klammer zu-imidazolin-(2) als bradykardes mittel |
JPH0710235A (ja) | 1993-06-21 | 1995-01-13 | Nhk Spring Co Ltd | 物品搬送シュート |
EP0920321A1 (de) * | 1996-08-26 | 1999-06-09 | Oswald Wiss | Vitaminpräparate mit sauerstoffsparender wirkung bei körperlicher leistung |
US20100190737A1 (en) * | 2009-01-26 | 2010-07-29 | Nutritional Research Group Llc | Compositions comprising inosine and orotic acid and methods of use thereof for the treatment of certain heart conditions and enhancement of work capacity |
JP2011098896A (ja) | 2009-11-04 | 2011-05-19 | Kirin Holdings Co Ltd | 尿酸値低下用組成物 |
JP2011136907A (ja) | 2009-12-25 | 2011-07-14 | Kirin Holdings Co Ltd | 持久力向上剤 |
JP2012126683A (ja) * | 2010-12-16 | 2012-07-05 | Kirin Holdings Co Ltd | 交感神経活性化用組成物 |
US10583165B2 (en) | 2015-05-13 | 2020-03-10 | Asahi Calpis Wellness Co., Ltd. | Method for suppressing increase in heart rate during exercise, and composition for suppressing increase in heart rate |
US11331318B2 (en) * | 2017-05-12 | 2022-05-17 | Furukawa Research Office Co., Ltd. | Arterial oxygen saturation degree improver |
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2019
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JP2012246280A (ja) * | 2011-05-31 | 2012-12-13 | Kirin Holdings Co Ltd | 酸素消費量及びエネルギー消費量の低減剤 |
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A.I. MARTYNOV ET AL.: ""Fifteen Years Experience of the Use of Magnesium Preparations in Patients with Mitral Valve Prolapse", 《KARDIOLOGIYA》, vol. 51, no. 6, pages 60 - 65, XP009527692 * |
SEO CHUNGJIN: "Effects of enthanol on the thermoregulatory responses during cold air exposure in male and female subjects" * |
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US20220016114A1 (en) | 2022-01-20 |
WO2020091014A1 (ja) | 2020-05-07 |
JP7162917B2 (ja) | 2022-10-31 |
JPWO2020091014A1 (ja) | 2021-09-24 |
EP3875093A1 (en) | 2021-09-08 |
EP3875093A4 (en) | 2022-07-27 |
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