CN118043060A - 卵巢功能活化剂、抗老化剂、医药品、化妆品以及食品或饮料 - Google Patents
卵巢功能活化剂、抗老化剂、医药品、化妆品以及食品或饮料 Download PDFInfo
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- CN118043060A CN118043060A CN202380013829.2A CN202380013829A CN118043060A CN 118043060 A CN118043060 A CN 118043060A CN 202380013829 A CN202380013829 A CN 202380013829A CN 118043060 A CN118043060 A CN 118043060A
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Abstract
含有由异黄酮、雌马酚、谷胱甘肽、左旋肉碱、bFGF、维生素C、维生素B1、维生素B2和维生素B6组成的组中的至少一种以及干细胞。
Description
技术领域
本发明涉及卵巢功能活化剂、抗老化剂、医药品、化妆品以及食品或饮料。
背景技术
女性在出生时在卵巢内已经存在所有卵子的起源,但随着年龄增加,卵子数减少,其品质也降低。也可以说,即使女性的结婚年龄逐年变高的现代没有明显不孕的原因,由于年龄增长所导致的卵巢功能的降低、即卵巢内的卵子的数量的降低和品质的降低,难以怀孕的女性也在增加。进而,卵巢功能降低也可以说对肌肤光泽等女性的外貌上的魅力产生影响。
虽然新制作卵母细胞、卵原干细胞(OSC)是困难的,但如果能够通过对从体外导入的干细胞给予分化诱导的刺激而提高向卵巢的归巢效应来实现卵巢功能的维持或提高,则关系到女性所存在的各种问题的解决。
即,为了实现抗老化(抗衰老)、为了保持女性的美丽和健康、或者为了恢复,维持、提高卵巢功能是不可或缺的因素。
需要说明的是,作为生殖细胞中的归巢效应,例如在专利文献1中提出了精巢功能改善剂。专利文献1中记载了,精巢功能改善剂在精巢内循环,发现疼痛的组织(也包括干细胞)时,通过归巢效应,组织(干细胞)自身活化并修复再生。
现有技术文献
专利文献
专利文献1:日本专利第6830286号公报
发明内容
发明所要解决的问题
本发明的目的在于提供能够通过提高向卵巢的归巢效应来维持或提高卵巢功能的卵巢功能活化剂、抗老化剂、医药品、化妆品以及食品或饮料。
用于解决问题的方法
本发明人进行了深入研究,结果发现,通过配合规定的成分,能够实现上述目的,从而完成了本发明。
即,根据本发明,提供:
(1)一种卵巢功能活化剂,其含有由异黄酮、雌马酚、谷胱甘肽、左旋肉碱、bFGF、维生素C、维生素B1、维生素B2和维生素B6组成的组中的至少一种以及干细胞;
(2)一种抗老化剂,其含有(1)所述的卵巢功能活化剂;
(3)一种医药品,其含有(1)所述的卵巢功能活化剂;
(4)一种化妆品,其含有(1)所述的卵巢功能活化剂;
(5)一种食品或饮料,其含有(1)所述的卵巢功能活化剂。
发明效果
根据本发明,提供能够通过提高向卵巢的归巢效应来维持或提高卵巢功能的卵巢功能活化剂、抗老化剂、医药品、化妆品以及食品或饮料。
附图说明
图1是示出实施例中的尿中雌激素量的测定结果的图。
图2是示出实施例中的血中的AMH量的测定结果的图。
图3是示出实施例中的皮肤水分量和透明质酸量的测定结果的图。
具体实施方式
以下,对本发明的卵巢功能活化剂进行说明。本发明的卵巢功能活化剂含有由异黄酮、雌马酚、谷胱甘肽、左旋肉碱、bFGF、维生素C、维生素B1、维生素B2和维生素B6组成的组(以下,有时称为“配合成分”)中的至少一种以及干细胞。
(配合成分)
本发明的卵巢功能活化剂含有由异黄酮、雌马酚、谷胱甘肽、左旋肉碱、bFGF、维生素C、维生素B1、维生素B2和维生素B6组成的组(以下,有时称为“配合成分”)中的至少一种。
作为异黄酮,可以优选使用3-苯基色酮,也可以部分或全部使用作为以3-苯基色酮为基本骨架的类黄酮的异黄酮类。
雌马酚具体是指7-羟基-3-(4’-羟基苯基)-色满。在此,雌马酚是属于异黄酮类的大豆黄酮通过肠内细菌或消化酶等代谢而生成的物质,作为本发明中使用的雌马酚,可以使用通过将大豆黄酮类进行化学还原而得到的合成雌马酚,也可以使用通过作为肠内细菌的一种的雌马酚产生菌使含有大豆黄酮类的原料代谢的代谢物。需要说明的是,作为大豆黄酮类,可以列举大豆黄酮、二氢大豆黄酮、大豆黄酮苷等。
谷胱甘肽是谷氨酸、半胱氨酸、甘氨酸依次肽键合而成的三肽。
左旋肉碱是由赖氨酸和甲硫氨酸合成的物质。
bFGF(碱性成纤维细胞生长因子)是显示多方面作用的增殖(生长)因子。需要说明的是,作为碱性成纤维细胞生长因子,有时也可以列举作为角质细胞生长因子KGF、KGF-2已知的碱性成纤维细胞生长因子7(FGF-7)、碱性成纤维细胞生长因子10(FGF-10),但在本发明中,优选使用bFGF(或者,也称为FGF2)。
维生素C、维生素B1、维生素B2和维生素B6是维生素类,可以使用合成的维生素类,也可以使用从天然物中提取的维生素类。
以下,有时将含有异黄酮、雌马酚、谷胱甘肽、左旋肉碱、bFGF(碱性成纤维细胞生长因子)、维生素C、维生素B1、维生素B2和维生素B6全部的物质称为“Stem-X”,但构成Stem-X的各成分的配合比没有特别限定。
(干细胞)
本发明的卵巢功能活化剂中使用的干细胞没有特别限定,可以使用间充质干细胞、造血干细胞、神经干细胞、表皮干细胞、胚胎干(ES)细胞、胚胎生殖(EG)细胞、卵巢来源干细胞、其他所有的组织干细胞等。其中,可以优选使用卵巢来源干细胞。另外,在使用干细胞时,优选以包含外泌体(Exosome)的状态使用。
另外,干细胞可以是人来源(自体细胞),也可以是异种来源(他体细胞)。作为异种来源的干细胞的种类,可列举牛、马、猪、狗、猫、小鼠、大鼠、羊等。另外,在使用自体细胞的情况下,可以使用自己的细胞,也可以使用他人的细胞。
(卵巢功能活化剂)
本发明的卵巢功能活化剂含有上述配合成分和干细胞。另外,配合成分与干细胞的配合比率没有特别限定,优选以重量基准计为5:95~95:5。
本发明的卵巢功能活化剂可以直接使用将上述配合成分和干细胞以一定的比率配合而成的物质,也可以在向干细胞中添加上述配合成分并在规定的条件下培养后使用。
本发明的卵巢功能活化剂通过在间充质干细胞培养液中添加一定量的多种配合试剂(由异黄酮、雌马酚、谷胱甘肽、左旋肉碱、bFGF、维生素C、维生素B1、维生素B2和维生素B6组成的组中的至少一种),被给药的干细胞或原本存在于体内的干细胞被诱导为卵母细胞、卵原干细胞(OSC)样细胞,带领其他干细胞聚集在卵巢中促进再生,结果提高卵巢功能。
具体而言,通过卵巢的卵子数的增加、分泌激素(雌激素等)量上升,成为卵巢功能上升的指标,进而作为其波及效果,能够期待用于抑制皮肤老化、特别是松弛的皮肤老化抑制效果。
另外,作为表示卵巢功能的其他指标,有表示残留于卵巢的卵子的数量相当于几岁的指标,称为“卵巢年龄”。卵巢年龄基于从卵子周围的细胞产生的激素即AMH(抗缪勒管激素)的测定结果来计算。另外,皮肤年龄由于水分量、皮肤的粘弹性、皮肤亮度、以及由明胶酶的上升所引起的胶原蛋白、弹性蛋白的破坏引起的皱纹而受到影响。
新制作卵母细胞、卵原干细胞(OSC)是困难的,但根据本发明,通过对从体外导入的干细胞给予分化诱导的刺激而提高向卵巢的归巢效应,能够实现卵巢功能的维持或提高。
(用途)
本发明的卵巢功能活化剂的目的在于维持提高美容和健康,可以在用于维持提高美容和健康的用途、用于抗老化(抗衰老)的用途中使用。即,特别是与针对女性特有的疾病的治疗等用途相比,能够用于前述的用途,因此,不仅所有的女性能够使用,而且鉴于肌肤的年轻化效果的用途,男性也能够使用。
另外,本发明的卵巢功能活化剂具有抗老化(抗衰老)的作用效果,因此也可以配合到以这些为目的的医药品中。作为医药品,预防药、治疗药中均可使用。
在配合于医药品的情况下,可以单独使用成分配合品,或者也可以与通常制剂上可允许的添加剂一起混合并制剂化。另外,作为给药形态,可以列举使用片剂、颗粒剂、胶囊剂、丸剂、散剂、液剂、悬浊剂、乳剂、糖浆剂、酏剂、浸膏剂等经口剂的给药形态,或者使用注射剂、液剂、栓剂、软膏剂、贴剂、巴布剂、洗剂等非经口剂的给药形态等,没有特别限制,可以根据治疗、预防的目的等适当选择。
另外,在片剂、颗粒剂、丸剂、胶囊剂、散剂的情况下,可以含有赋形剂、粘合剂、崩解剂、润滑剂等添加剂。作为赋形剂,可以列举淀粉、羧甲基纤维素、白糖、糊精、玉米淀粉等。
作为粘合剂,可以列举结晶纤维素、结晶纤维素-羧甲基纤维素钠、甲基纤维素、羟丙基纤维素、低取代度羟丙基纤维素、羟丙基甲基纤维素、羟丙基甲基纤维素邻苯二甲酸酯、乙酸羟丙基甲基纤维素琥珀酸酯、羧甲基纤维素钠、乙基纤维素、羧甲基乙基纤维素、羟乙基纤维素、小麦淀粉、大米淀粉、玉米淀粉,马铃薯淀粉、糊精、α化淀粉、部分α化淀粉、羟丙基淀粉、普鲁兰多糖、聚乙烯吡咯烷酮、甲基丙烯酸氨基烷基酯共聚物E、甲基丙烯酸氨基烷基酯共聚物RS、甲基丙烯酸共聚物L、甲基丙烯酸共聚物、聚乙烯醇缩醛二乙基氨基乙酸酯、聚乙烯醇、阿拉伯胶、阿拉伯胶粉末、琼脂、明胶、白色虫胶、黄蓍胶、精制白糖、聚乙二醇(Macrogol)。
作为崩解剂,可以列举结晶纤维素、甲基纤维素、低取代度羟丙基纤维素、羧甲基纤维素、羧甲基纤维素钙、羧甲基纤维素钠、交联羧甲基纤维素钠、小麦淀粉、大米淀粉、玉米淀粉、马铃薯淀粉、部分α化淀粉、羟丙基淀粉、羧甲基淀粉钠和黄蓍胶。
作为润滑剂,可以列举小麦淀粉、大米淀粉、玉米淀粉、硬脂酸、硬脂酸钙、硬脂酸镁、含水二氧化硅、轻质无水硅酸、合成硅酸铝、干燥氢氧化铝凝胶、滑石、偏硅酸铝镁、磷酸氢钙、无水磷酸氢钙、蔗糖脂肪酸酯、蜡类、氢化植物油、聚乙二醇。
另外,在液剂、糖浆剂、悬浊剂、乳剂、酏剂的情况下,除了水、植物油等通常使用的非活性稀释剂以外,还可以含有着色剂、矫味剂、着香剂等作为添加剂。
另外,在注射剂的情况下,可以含有悬浊液、乳浊液、使用时溶解剂等添加剂。另外,在软膏剂、栓剂的情况下,可以含有脂肪、脂肪油、羊毛脂、凡士林、石蜡、蜡、树脂、塑料、基剂、二醇类、高级醇、水、乳化剂、助悬剂等作为添加剂。另外,在巴布剂的情况下,可以含有甘油、水、水溶性高分子、吸水性高分子等作为添加物。另外,在洗剂的情况下,可以含有溶剂、乳化剂、助悬剂等作为添加剂。
另外,也可以将本发明的卵巢功能活化剂配合到化妆品中。作为化妆品,可列举化妆水、乳液、洗面奶、卸妆乳、美容液、乳霜、粉底、眉笔、睫毛膏、眼影、眼线、口红、唇彩、腮红、扑粉、指甲油等。另外,作为化妆品的形态,可以采用液体、霜、固体、棒、粉末等形态。
另外,也可以将本发明的卵巢功能活化剂配合到食品或饮料等中。作为食品,可列举面包类、面类、点心类、食用肉加工品、鱼贝类加工品、冷冻食品、果冻类、冰激凌类、乳制品、各种调味料等。另外,除了一般食品以外,也可以配合于特定保健用食品、医药部外品、健康食品、补充剂。作为饮料,可列举清凉饮料水、乳饮料、酒类、茶、红茶饮料、咖啡、果汁饮料、碳酸饮料、矿物质水类、果实/蔬菜饮料等。
另外,可以将配合有本发明的卵巢功能活化剂的食品或饮料制成与片剂、胶囊剂、糖浆等经口给药制剂相同的形态。
另外,在制造配合有本发明的卵巢功能活化剂的食品或饮料时,在不妨碍本发明的效果的范围内,可以根据需要添加甜味剂、着色剂、防腐剂、增稠剂、稳定剂、凝胶化剂、抗氧化剂、显色剂、漂白剂、乳化剂、膨胀剂、酸味剂、光泽剂、香料等添加剂;溶剂;油。这些添加剂可以单独使用各种,也可以组合使用两种以上。
上述食品或饮料中配合的本发明的卵巢功能活化剂的比例可以根据使用目的适当调整,但上述食品或饮料中配合的成分配合品的比例优选为0.01~20重量%,更优选为0.01~15重量%,进一步优选为0.1~10重量%。
实施例
以下,列举实施例对本发明进行说明,但本发明并不限定于此。
将异黄酮、雌马酚、谷胱甘肽、左旋肉碱、bFGF、维生素C、维生素B1、维生素B2和维生素B6溶解于超纯水或生理盐水中,准备“Stem-X”溶液。
对老年小鼠(ICR;25周龄、雌性)从尾静脉以0.5ml给药“Stem-X”溶液和来源于小鼠卵巢的干细胞悬浊液。同样也制作仅干细胞、仅溶液的给药组。包括未给药组小鼠在内,将4组小鼠在同样的饲养条件下经过3周和6周进行观察。6周组在经过3周的阶段,追加实施与第一次同样的给药(第二次给药)。在观察期间内,自由摄取相同的固体饲料和饮料水。从经过3周和6周的各组的小鼠采集尿,分别用ELISA法(Estrone;K031-H1,17β-Estradiol;K030-H1,Estriol;K064-H1,全部Arbor Assays公司)测定尿中雌激素量(雌酮、17β-雌二醇、雌三醇)。另外,在眼静脉丛、及戊巴比妥麻醉下进行颈静脉采血后,利用抗缪勒管激素(AMH)ELISA试剂盒(Cloud-Clone Corp.Wuhan;CEA228BO)测定血中的AMH(抗缪勒管激素)量。
小鼠的性周期为4~5天,因此尿中雌激素量在第3周(6wks)、第6周(6wks)、分别21天至25天、以及42天至46天的5天连续测定,以将同一周龄的非给药小鼠的值设为100%时的%来表示。关于AMH的测定,在第21天和第42天通过眼静脉丛采血进行,在第25天和第46天通过颈静脉采血进行。(3周实验组和6周实验组分别用不同的小鼠实施)
另外,从实验开始起第25天(Day 25)和第45天(Day 45)实验结束时的小鼠采集后背部皮肤,利用常压加热干燥法(MX-50;株式会社A&D制)测定水分含量,利用ELISA法(Hyaluronan Quantikine ELISA Kit;R&D systems制)测定皮肤透明质酸量。透明质酸测定用皮肤按个体进行冷冻粉碎,在液氮下将皮肤粉碎至粉状。将得到的冷冻粉碎皮肤在乙醇(99.5%)中、4℃的条件下进行一夜脱脂。接着添加加入有蛋白酶抑制剂的PBS(-)(将5mM苯甲脒盐酸盐/10mM EDTA-2Na/0.1M氨基己酸溶解于PBS(-),pH 7.4),在4℃下利用旋转器旋转3~4小时,进行离心分离,除去上清后,将沉淀物溶解于加入有蛋白酶抑制剂的PBS(-),作为ELISA用样本。
将尿中雌激素量的测定结果示于图1,将血中的AMH量的测定结果示于图2,将皮肤水分量和透明质酸量的测定结果示于图3。需要说明的是,图1~图3中的实验组如下所述。
1组:生理盐水给药组
2组:小鼠卵巢来源干细胞悬浊液
3组:Stem-X溶液给药组
4组:小鼠卵巢来源干细胞悬浊液和Stem-X溶液给药组
如图1所示,尿中雌激素(雌酮、17β-雌二醇、雌三醇)的测定结果在第3周(3wks)、第6周(6wks)大致相同,与1组相比,2组(单独给药了小鼠卵巢来源干细胞悬浊液的组)和3组(单独给药了Stem-X溶液的组)的雌激素值上升。进而,与2组和3组相比,4组(给药了小鼠卵巢来源干细胞悬浊液和Stem-X溶液两者的组)的雌激素值上升。
如图2所示,血清中AMH量的测定结果为与尿中雌激素同样的倾向,与1组相比,2组(单独给药了小鼠卵巢来源干细胞悬浊液的组)和3组(单独给药了Stem-X溶液的组)的AMH量上升。进而,与2组和3组相比,4组(给药了小鼠卵巢来源干细胞悬浊液和Stem-X溶液两者的组)的AMH量上升。另外表明,第6周(6wks;2次给药组)显示出比第3周(3wks;1次给药)高的结果。由此,考虑到定期给药的优越性。
如图3所示,皮肤水分量和透明质酸量均在3组、4组中显示出高的值,这在第3周(3wks)、第6周(6wks)均为同样的倾向。通过2次给药,4组的透明质酸量为最高值。
在整个实验期间,外观上小鼠的体毛在2、3、4组中明显比在1组中更光滑。此外,小鼠体重、卵巢重量在各组间没有观察到差异。进而,虽然有可能由于长期反复给药而观察到变化,但确认了在本次的2次给药中体内的指标(尿、血液)已经向良好的方向改善。
根据这些结果设想了,在体外将本试剂、“Stem-X”添加到干细胞培养液中的情况、或者与干细胞一起导入到体内的情况下,使干细胞向卵巢接近(归巢效应),或者召集原来存在于体内的干细胞,或者直接作用于卵巢等来提高卵巢功能。此外还暗示了,“Stem-X”的作为体内循环所引起的副作用抑制皮肤老化。
Claims (5)
1.一种卵巢功能活化剂,其含有由异黄酮、雌马酚、谷胱甘肽、左旋肉碱、bFGF、维生素C、维生素B1、维生素B2和维生素B6组成的组中的至少一种以及干细胞。
2.一种抗老化剂,其含有权利要求1所述的卵巢功能活化剂。
3.一种医药品,其含有权利要求1所述的卵巢功能活化剂。
4.一种化妆品,其含有权利要求1所述的卵巢功能活化剂。
5.一种食品或饮料,其含有权利要求1所述的卵巢功能活化剂。
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