CN117643585A - 女性特有的身体和/或精神不快症状的改善剂 - Google Patents
女性特有的身体和/或精神不快症状的改善剂 Download PDFInfo
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Abstract
本发明提供一种女性特有的身体和/或精神不快症状的改善效果较高、且能够方便地进行摄取的类型的改善剂。本发明提供一种包含γ‑生育酚和/或雌马酚的女性特有的身体和/或精神不快症状的改善剂。
Description
本申请是申请号为201780024029.5、申请日为2017年3月7日、发明名称为“女性特有的身体和/或精神不快症状的改善剂”的专利申请的分案申请。
技术领域
本发明是关于一种女性特有的身体和/或精神不快症状的改善剂。
背景技术
所谓女性特有的身体和/或精神不快症状是被认为一原因为女性激素等的变动等的不快症状。女性特有的身体和/或精神不快症状包括:月经前的身体和/或精神不快症状(还称为月经前症候群「PMS」)、及包括生理痛的月经中的身体和/或精神不快症状、以及由生理不畅、子宫异常出血、自律神经失调症、不孕、更年期障碍等引起的不快症状。
例如PMS主要持续在月经前3~10天之间,随着月经开始而症状减轻或消失。作为原因之一,可列举雌激素(卵胞激素)及孕酮(黄体激素)的急遽减少,但认为还存在其他多个因素,PMS的原因尚未明确。作为PMS的症状,可列举:困倦、腰痛、下腹部痛、头痛、易疲劳、肩酸、浮肿、乳房胀痛、眩晕、皮肤粗糙、痤疮、忧虑、不安、倦怠感、无力、集中力低下、焦躁等各种症状。
另外,月经中的身体和/或精神不快症状表现为下腹部痛、腰痛、头痛等身体疼痛、全身感觉倦怠或倦乏等莫名的不舒服、焦躁、无力、忧虑、易怒、恶心、胃痛、食欲不振、下痢、眩晕等各种症状。月经中的身体和/或精神不快症状的原因还尚未明确,认为还由多个因素引起。
关于女性特有的身体和/或精神不快症状的治疗或预防,由于其原因不确定、或个体间症状的特征或期间存在差异,故而一般采用对症疗法、或借由改善饮食、养成运动习惯、消除压力等自我管理而缓和症状的方法。
例如关于PMS的对症疗法,对多种成分进行了有效性研究,报告有包含大豆异黄酮苷元、尤其大豆黄酮(daidzein)的PMS治疗剂(专利文献1)。进而,针对由大豆黄酮代谢生成的雌马酚(equol)对PMS的影响进行了研究(非专利文献1)。另外,已知使用γ-生育酚以改善浮肿等水分蓄积症状。
先前技术文献
专利文献
[专利文献1]日本专利特开2003-300879号公报
非专利文献
[非专利文献1]东京医疗保健大学纪要,第1号2006年,第39-42页
发明内容
发明所希望解决的问题
多数女性均有过女性特有的身体和/或精神不快症状的体验,严重时甚至会影响日常生活。另一方面,女性的社会参与率提升,能够方便地在外出途中等进行摄取的类型的女性特有的身体和/或精神不快症状的改善剂受到期待。然而,业界尚未开发出女性特有的身体和/或精神不快症状的改善效果较高、且能够方便地进行摄取的类型的改善剂。
解决问题的技术手段
基于上述状况,本发明者等人为了开发出能够方便地进行摄取的类型的女性特有的身体和/或精神不快症状改善剂,进行了努力研究。其结果发现,借由组合给予γ-生育酚和/或雌马酚而显著改善女性特有的身体和/或精神不快症状,例如月经前和/或月经中的身体和/或精神不快症状,从而完成了本发明。
即,本发明提供
[1]一种女性特有的身体和/或精神不快症状的改善剂,其包含γ-生育酚及雌马酚;
[2]如[1]记载的改善剂,其以个别剂的形式分别包含γ-生育酚与雌马酚;
[3]如[1]记载的改善剂,其以同一剂的形式包含γ-生育酚与雌马酚;
[4]如[1]至[3]中任一项记载的改善剂,其中上述女性特有的身体和/或精神不快症状为选自由疼痛、负向情绪、集中力、及行为变化所组成的群中的一种以上;
[5]如[1]至[4]中任一项记载的改善剂,其中上述女性特有的身体和/或精神不快症状为月经前和/或月经中的身体和/或精神不快症状;
[6]如[1]至[5]中任一项记载的改善剂,其中γ-生育酚与雌马酚的调配比率(总量的重量比)为1:0.0001~1:500;
[7]如[1]至[6]中任一项记载的改善剂,其含有含雌马酚的大豆胚轴酦酵物作为雌马酚;
[8]如[1]至[7]中任一项记载的改善剂,其是用以使γ-生育酚的单日摄取量成为0.1~1000mg、及雌马酚的单日摄取量成为0.1~50mg而摄取;
[9]一种饮食品,其包含如[1]至[8]中任一项记载的改善剂;
[10]如[1]至[8]中任一项记载的改善剂,其为饮食品的形式;
[11]一种女性特有的身体和/或精神不快症状的改善剂,其包含γ-生育酚;
[12]如[11]记载的改善剂,其中女性特有的身体和/或精神不快症状为选自由疼痛、负向情绪、集中力、及行为变化所组成的群中的一种以上;
[13]如[11]或[12]记载的改善剂,其中女性特有的身体和/或精神不快症状为月经前和/或月经中的身体和/或精神不快症状;
[14]如[11]至[13]中任一项记载的改善剂,其是用以使γ-生育酚的单日摄取量成为0.1~1000mg而摄取;
[15]一种饮食品,其包含如[11]至[14]中任一项记载的改善剂;
[16]如[11]至[14]中任一项记载的改善剂,其为饮食品的形式;
[17]一种女性特有的身体和/或精神不快症状的改善剂,其包含雌马酚;
[18]如[17]记载的改善剂,其中女性特有的身体和/或精神不快症状为选自由疼痛、负向情绪、集中力、及行为变化所组成的群中的一种以上;
[19]如[17]或[18]记载的改善剂,其中女性特有的身体和/或精神不快症状为月经前和/或月经中的身体和/或精神不快症状;
[20]如[17]至[19]中任一项记载的改善剂,其含有含雌马酚的大豆胚轴酦酵物作为雌马酚;
[21]如[17]至[20]中任一项记载的改善剂,其是用以使雌马酚的单日摄取量成为0.1~50mg而摄取;
[22]一种饮食品,其包含如[17]至[21]中任一项记载的改善剂;以及
[23]如[17]至[21]中任一项记载的改善剂,其为饮食品的形式。
发明的效果
本发明发挥以下的1个以上的效果。
(1)可提供一种女性特有的身体和/或精神不快症状的改善剂(以下称为「本发明的改善剂」)。
(2)尤其可提供一种月经前和/或月经中的身体和/或精神不快症状的改善剂。
(3)可提供一种能够方便地进行摄取的类型的本发明的改善剂。
附图说明
图1表示γ-生育酚单独试验时的VAS的结果。图中,「γ-Toc」意指γ-生育酚。
图2表示γ-生育酚单独试验、及γ-生育酚与雌马酚并用试验的MDQ的结果。图中的「γToc」意指γ-生育酚。
图3表示γ-生育酚与雌马酚并用试验的整体改善度的结果。
具体实施方式
所谓「γ-生育酚」是大豆油或菜籽油等植物油中所含之一种天然维生素E。已知维生素E具有防止体内脂肪氧化的优异的抗氧化作用。本发明中使用的γ-生育酚并无特别限定。例如可使用作为制药用或食品用原材料而市售的γ-生育酚。
本发明中,γ-生育酚的每日摄取量取决于所希望改善的症状的程度,例如为0.1~1000mg,较优选为50~800mg,更优选为60~450mg。本发明的改善剂所含的γ-生育酚的量可考虑到本发明的改善剂的形状等,在上述γ-生育酚的每日摄取量的范围内适当决定。只要以达到上述每日摄取量的方式摄取1个~多个本发明的改善剂即可。
所谓「雌马酚」是主要以与糖结合的配糖体的形式存在的异黄酮类经体内的消化酵素或肠内细菌所产生的酵素等转化后产生的代谢物,具有较高的雌激素活性。本发明中使用作为选自由大豆黄酮配糖体、大豆黄酮及二氢大豆黄酮所组成的群中的至少一种大豆黄酮类的代谢物的雌马酚。作为大豆黄酮配糖体,例如可列举:大豆苷(daidzin)、丙二酰大豆苷、乙酰大豆苷等。本发明中使用的雌马酚并无特别限定,可为借由合成法所得者,或还可为借由酦酵法所得者。
本发明中,还可使用含有雌马酚的大豆胚轴酦酵物(以下称为「含雌马酚的大豆胚轴酦酵物」。含雌马酚的大豆胚轴酦酵物是借由利用具有将选自由大豆黄酮配糖体、大豆黄酮及二氢大豆黄酮所组成的群中的至少一种大豆黄酮类同化而产生雌马酚的能力的微生物,使大豆胚轴酦酵而获得。已知所谓大豆胚轴是在大豆发芽时成为幼芽、幼根的部分,包含大量的大豆黄酮配糖体或大豆黄酮等大豆黄酮类。本发明中使用的大豆胚轴只要为含有大豆黄酮类者则均可,关于大豆的种类、产地或加工的有无、大豆胚轴的形状等并无限制。例如可为原始状态者,自经过加热处理、干燥处理或蒸煮处理等的大豆所分离出者,将自未加工的大豆所分离出的胚轴供于加热处理、干燥处理或蒸煮处理等所得者,经脱脂处理或脱蛋白处理者,粉末状、或经粉碎或破碎者。作为上述具有产生雌马酚的能力的微生物,只要为食品卫生上所容许、且具有雌马酚产生能力,则并无特别限制,例如可列举:格氏乳球菌(Lactococcus garvieae)等属于乳球菌属的微生物、中间链球菌(Streptococcusintermedius)、星群链球菌(Streptococcus constellatus)等属于链球菌属的微生物、卵形拟杆菌(Bacteroides ovatus)等属于拟杆菌属的微生物。上述具有产生雌马酚的能力的微生物还可例如以雌马酚产生能力作为指标而自人类粪便中进行单离。进而,还可使用如下由申请人单离并鉴定的寄存菌:乳球菌20-92(FERM BP-10036)、链球菌E-23-17(FERMBP-6436)、链球菌A6G225(FERM BP-6437)及拟杆菌E-23-15(FERM BP-6435)。含有雌马酚的大豆胚轴酦酵物可借由使用上述具有产生雌马酚的能力的微生物,使上述大豆胚轴在适当条件下酦酵而获得。只要可产生雌马酚,则酦酵条件并无特别限制,由业者适当决定。例如可使用借由国际公开第WO 2007/066655号所记载的方法而获得的含雌马酚的大豆胚轴酦酵物。
含雌马酚的大豆胚轴酦酵物除包含雌马酚以外,还包含大豆苷、丙二酰大豆苷、乙酰大豆苷、大豆黄酮、二氢大豆黄酮等大豆黄酮类、金雀异黄苷(genistin)、丙二酰金雀异黄苷、乙酰金雀异黄苷、金雀异黄酮(genistein)、二氢金雀异黄酮等金雀异黄酮类、黄豆黄苷(Glycitin)、丙二酰黄豆黄苷、乙酰黄豆黄苷、黄豆黄素(Glycitein)、二氢黄豆黄素等黄豆黄素类等各种异黄酮,从而还可表现出该等异黄酮的有用生理活性。进而,含雌马酚的大豆胚轴酦酵物还包含源自大豆胚轴的皂苷,从而还可表现出皂苷的有用生理活性(例如抗病毒活性等)。因此,在本发明的改善剂含有含雌马酚的大豆胚轴酦酵物的情形时,可期待附加效果。含雌马酚的大豆胚轴酦酵物其雌马酚以外的异黄酮类的组成还与大豆胚轴中的组成不同。尤其大豆胚轴酦酵物中的担忧作为内分泌扰乱物质发挥作用的金雀异黄酮类的含有比率较低。
关于本发明中使用的含雌马酚的大豆胚轴酦酵物,每1g(干燥重量)该大豆胚轴酦酵物中,含有雌马酚例如1~20mg、较优选为2~12mg,含有大豆黄酮类以总量计例如0.1~30mg、较优选为0.1~1.5mg,含有金雀异黄酮类以总量计例如0.05mg~2.5mg、较优选为0.05~2mg,及含有黄豆黄素类以总量计例如0.1~4mg、较优选为2~3.5mg。另外,关于含雌马酚的大豆胚轴酦酵物中的各异黄酮的组成比率,以相对于该大豆胚轴酦酵物所含的全部异黄酮的合计重量的比率计,雌马酚例如为30~75重量%、较优选为40~70重量%、更优选为45~70重量%,大豆黄酮类例如为1~20重量%、较优选为2~15重量%、更优选为4~12重量%,金雀异黄酮类例如为0.1~20重量%、较优选为1~15重量%、更优选为1~10重量%,黄豆黄素类例如为10~50重量%、较优选为15~35重量%、更优选为25~35重量%。另外,关于含雌马酚的大豆胚轴酦酵物中的皂苷含量,每1g(干燥重量)该大豆胚轴酦酵物中例如为10~80mg、较优选为20~50mg、更优选为30~40mg。
上述具有产生雌马酚的能力的微生物中还存在具有将精胺酸转化为鸟胺酸的能力者,可自格氏乳球菌中进行选择。例如可列举乳球菌20-92(FERM BP-10036)。在使用此种微生物而使大豆胚轴酦酵的情形时,借由对该大豆胚轴添加精胺酸而进行酦酵,可使所获得的含雌马酚的大豆胚轴酦酵物中含有鸟胺酸。关于此种含雌马酚的大豆胚轴酦酵物中的鸟胺酸含量,每1g(干燥重量)该大豆胚轴酦酵物中例如为0.5~2mg,较优选为8~15mg,更优选为9~12mg。此种含雌马酚的大豆胚轴酦酵物还可表现出基于鸟胺酸的有用生理活性。
本发明中,在使用含雌马酚的大豆胚轴酦酵物的情形时,该含雌马酚的大豆胚轴酦酵物可直接以酦酵后的状态使用,或还可视需要供于加热处理而成为干燥固形物状后使用。就保存稳定性的观点而言,含雌马酚的大豆胚轴酦酵物较优选为借由加热干燥处理而成为固形状。另外,经加热干燥处理的含雌马酚的大豆胚轴酦酵物视需要还可供于粉末化处理而成为粉末状。
本发明中,雌马酚的每日摄取量取决于所希望改善的症状的程度,例如为0.1~50mg,较优选为0.5~30mg,更优选为1~20mg。本发明的改善剂所含的雌马酚的量可考虑到本发明的改善剂的形状等,在上述雌马酚的每日摄取量的范围内适当决定。只要以达到上述每日摄取量的方式摄取1个~多个本发明的改善剂即可。
本发明中,含雌马酚的大豆胚轴酦酵物的每日量取决于所希望改善的症状或该大豆胚轴酦酵物中的雌马酚含量,例如为0.005~5g,较优选为0.025~30g,更优选为1~20g。
包含γ-生育酚及雌马酚的本发明的改善剂所含的γ-生育酚与雌马酚的调配比率(总量的重量比)并无特别限定,例如为1:0.0001~1:500,较优选为1:0.0006~1:0.6,更优选为1:0.002~1:0.3。
本发明的改善剂还可包含无损女性特有的身体和/或精神不快症状的改善效果的其他成分。作为其他成分,例如可适当调配维生素、矿物质(例如钾、钙、镁、铁、锌等)等营养强化剂,乳糖、淀粉、纤维素、麦芽糖醇及糊精等赋形剂,甘油脂肪酸酯及蔗糖脂肪酸酯等界面活性剂,明胶、虫胶及玉米蛋白等被膜剂,小麦胚芽油、米胚芽油及葵花籽油等油脂类,蜂蜡、米糠蜡等蜡类,蔗糖、葡萄糖、果糖、甜菊、糖精及蔗糖素等甜味剂,以及柠檬酸、苹果酸及葡萄糖酸等酸味剂等。
本发明的改善剂还可进而包含溶剂、分散剂、乳化剂、稳定化剂、缓冲剂、增量剂、黏合剂、崩散剂、润滑剂等各种添加剂。
在本发明的改善剂包含钙的情形时,钙量并无特别限定,作为钙的每日摄取量,例如为0.1~2500mg,较优选为50~650mg,更优选为100~300mg。本发明的改善剂所含的钙量可在上述钙的每日摄取量的范围内适当决定。
在本发明的改善剂包含铁的情形时,铁量并无特别限定,作为铁的每日摄取量,例如为0.1~40mg,较优选为0.2~15mg,更优选为0.5~10mg。典型而言,在本发明中,铁的每日摄取量约为4mg。本发明的改善剂所含的铁量可在上述铁的每日摄取量的范围内适当决定。
本发明的改善剂可用作医药、各种饮食品或食品用组成物,并无限定。此处,所谓食品用组成物意指用以制造饮食品的饮食品用原材料、食品添加剂等。本发明的改善剂还可用作功能性表现食品、特定保健用食品、健康食品、营养辅助食品(补充品)、医疗用食品等饮食品。
作为本发明的改善剂的形状,可采用通常的医药或饮食品的形式。例如可列举:锭剂、颗粒剂、胶囊剂(例如软胶囊剂或硬胶囊剂)、粉末剂、液剂、悬浮剂、发泡剂、咀嚼锭、点心类(例如曲奇、饼干、巧克力点心、薯片、蛋糕、口香糖、糖果、软糖、馒头、羊羹、布丁、果冻、酸奶酪、冰淇淋、雪酪等)、面包、面条类、米饭类、系列食品、饮料(例如清凉饮料、碳酸饮料、营养饮料、粉末饮料、果肉饮料、乳饮料、果冻饮料等)、汤(例如粉末汤、冷冻干燥实时浓汤、罐头汤等)、味噌汁(例如粉末味噌汁、冷冻干燥实时味噌汁等)等。本发明的改善剂可借由常规方法制成上述任一种形状。
在包含γ-生育酚及雌马酚的本发明的改善剂中,γ-生育酚及雌马酚可以个别剂的形式分别包含,还可以同一剂的形式包含。
在包含γ-生育酚及雌马酚的本发明的改善剂中以个别剂的形式分别包含γ-生育酚及雌马酚的情形时,各剂可为具有相同形状者,或还可为具有不同形状者。例如包含γ-生育酚及雌马酚的本发明的改善剂可含有包含γ-生育酚的胶囊剂与包含雌马酚的锭剂的组合。或者包含γ-生育酚及雌马酚的本发明的改善剂还可为包含γ-生育酚的锭剂与包含雌马酚的锭剂的组合,还可为包含γ-生育酚与雌马酚的锭剂。另外,包含γ-生育酚及雌马酚的本发明的改善剂还可为一并包含γ-生育酚及雌马酚的饮食品。
本发明的改善剂包括:包含γ-生育酚作为有效成分的改善剂、包含雌马酚作为有效成分的改善剂、及包含γ-生育酚与雌马酚作为有效成分的改善剂。借由将γ-生育酚与雌马酚并用,而在可同时享有该两种有效成分的效果方面较为有利。
本发明的改善剂例如1天摄取1次~数次。本发明的改善剂的摄取期间并无特别限定,例如可数天间~数周间进行摄取,还可1月间~数月间进行摄取。例如在自月经前至月经结束时的期间,可在出现不快症状时进行摄取,或还可在出现不快症状之前进行预防性摄取。本发明的改善剂在上述摄取期间内可间断地或连续地摄取。
关于本发明的改善剂的摄取量,只要可获取各成分的单日摄取量,则并无特别限定。在本发明的改善剂包含γ-生育酚及雌马酚、且γ-生育酚及雌马酚是以个别剂的形式分别包含的情形时,包含γ-生育酚的剂与包含雌马酚的剂可同时摄取,或还可在时间上隔开间隔地分别摄取。
本发明的改善剂的包装形式并无特别限定,只要以医药或饮食品通常所用的形式进行包装即可。例如可列举利用PTP(polyterephthalate,聚对苯二甲酸酯)片材、铝箔、各种膜、箱、袋、PET瓶、罐、瓶、纸袋等的包装。其中,为了能够方便地进行摄取,较优选为可携带类型的包装形式。例如在包含γ-生育酚及雌马酚的本发明的改善剂中以个别剂的形式分别包含γ-生育酚及雌马酚的情形时,各剂可分别包装,或还可一并包装。本发明的改善剂较优选为以内装单日量的各成分的方式包装1种剂或一并包装多种剂。进而,还可将含有单日量的各成分的包装物以包含多个,例如1~数周的份量的方式进行包装。
例如包含γ-生育酚及雌马酚的本发明的改善剂可将包含γ-生育酚的胶囊剂1粒与包含雌马酚的锭剂2粒设为一组而作为单日量包装在1个袋内。进而,例如可将内装有上述一组的袋以7天份(7袋)包装在单个包装(例如箱)内,或还可以30天份(30袋)包装在单个包装内。或者作为包含γ-生育酚及雌马酚的饮食品的形式,可包装在能够携带相当于γ-生育酚及雌马酚的单日摄取量的量的包装内。
本发明的改善剂所改善的所谓「女性特有的身体和/或精神不快症状」是认为一原因为女性激素等的变动等的各种不快症状,包括:月经前症候群(「PMS」)、及包括生理痛的月经中的身体和/或精神不快症状、以及由生理不畅、子宫异常出血、自律神经失调症、不孕、更年期障碍等引起的不快症状。具体而言,例如可列举:困倦、腰痛、下腹部痛、头痛、易疲劳、肩酸、浮肿、乳房胀痛、眩晕、皮肤粗糙、痤疮、忧虑、不安、倦怠感、无气力、集中力低下、焦躁感、易怒、恶心、胃痛、食欲不振、下痢等不快症状。
进而,还可将本发明的改善剂所改善的「女性特有的身体和/或精神不快症状」的主要症状大体分为水分蓄积、负向情绪、疼痛、集中力、及行动力的变化。此处,所谓「水分蓄积」意指体重增加、皮肤粗燥(例如痤疮)、乳房胀痛、浮肿(腹部、乳房、足部)等各种症状。所谓「负向情绪」意指想哭、感觉空寂、感觉不安、心绪不宁、焦躁、易怒、情绪不稳、感觉忧虑、易紧张等各种症状。所谓「疼痛」意指肩部或颈部酸痛、头痛、下腹部痛、腰痛、易疲劳、身体痛等症状。所谓「集中力」意指失眠、健忘、思想不集中、判断力迟钝、集中力下降、精神涣散、意想不到地失败、动作迟钝等相关症状。所谓「行动力的变化」意指对学习或工作失去毅力、打瞌睡、闷局家中、躲避人际交往、学习或工作的效率低下等。
另外,本发明提供一种女性特有的身体和/或精神不快症状的改善方法,其特征在于给予γ-生育酚及雌马酚。进而,作为另一方面,本发明提供一种γ-生育酚及雌马酚的用途,其用于改善女性特有的身体和/或精神不快症状。另外,作为另一方面,本发明提供一种γ-生育酚及雌马酚的用途,其用于制造女性特有的身体和/或精神不快症状的改善剂。
本发明中,所谓「改善」包括上述不快症状的减轻、预防及治疗。因此,本发明还提供一种女性特有的身体和/或精神不快症状的减轻、预防和/或治疗剂,其包含γ-生育酚及雌马酚。进而,本发明提供一种女性特有的身体和/或精神不快症状的减轻、预防和/或治疗方法,其特征在于给予γ-生育酚及雌马酚。进而,作为另一方面,本发明提供一种γ-生育酚及雌马酚的用途,其用于减轻、预防和/或治疗女性特有的身体和/或精神不快症状。另外,作为另一方面,本发明提供一种γ-生育酚及雌马酚的用途,其用于制造女性特有的身体和/或精神不快症状的减轻、预防和/或治疗剂。
进而,本发明中发现,γ-生育酚不仅具有水分蓄积改善效果,且还改善疼痛、负向情绪、集中力、及行为变化等的身体和/或精神不快症状。因此,本发明提供一种女性特有的身体和/或精神不快症状的改善剂,其包含γ-生育酚;提供一种女性特有的身体和/或精神不快症状的改善方法,其特征在于给予γ-生育酚;提供一种γ-生育酚的用途,其用于改善女性特有的身体和/或精神不快症状;及提供一种γ-生育酚的用途,其用于制造女性特有的身体和/或精神不快症状的改善剂。进而,作为另一方面,本发明提供一种女性特有的身体和/或精神不快症状的减轻、预防和/或治疗剂,其包含γ-生育酚;提供一种女性特有的身体和/或精神不快症状的减轻、预防和/或治疗方法,其特征在于给予γ-生育酚;提供一种γ-生育酚的用途,其用于减轻、预防和/或治疗女性特有的身体和/或精神不快症状;提供一种γ-生育酚的用途,其用于制造女性特有的身体和/或精神不快症状的减轻、预防和/或治疗剂。
进而,本发明中发现,雌马酚还改善疼痛、负向情绪、集中力、及行为变化等身体和/或精神不快症状。因此,本发明提供一种女性特有的身体和/或精神不快症状的改善剂,其包含雌马酚;提供一种女性特有的身体和/或精神不快症状的改善方法,其特征在于给予雌马酚;提供一种雌马酚的用途,其用于改善女性特有的身体和/或精神不快症状;及提供一种雌马酚的用途,其用于制造女性特有的身体和/或精神不快症状的改善剂。进而,作为另一方面,本发明提供一种女性特有的身体和/或精神不快症状的减轻、预防和/或治疗剂,其包含雌马酚;提供一种女性特有的身体和/或精神不快症状的减轻、预防和/或治疗方法,其特征在于给予雌马酚;提供一种雌马酚的用途,其用于减轻、预防和/或治疗女性特有的身体和/或精神不快症状;提供一种雌马酚的用途,其用于制造女性特有的身体和/或精神不快症状的减轻、预防和/或治疗剂。
在本说明书中,除特别定义或说明的用语以外的用语可以医药品或食品领域中通常采用的含义进行解释。
实施例
以下,揭示实施例而说明本发明,但本发明并不限定于该等实施例。实施例所示的调配量为每个制剂的调配量。
实施例1:软胶囊+锭剂
使用适量的胶囊基剂、赋形剂等,借由常规方法制作如下制剂:含有γ-生育酚360mg的软胶囊、以及含有包含雌马酚1mg的大豆胚轴酦酵物及钙125mg的锭剂。再者,含雌马酚的大豆胚轴酦酵物是借由国际公开第WO 2007/066655号所记载的方法而制造。将胶囊1粒及锭剂2粒设为一组。
试验例1:γ-生育酚单独试验
以25名在月经前存在水分蓄积者作为对象,实施随机分组安慰剂对照二重盲检试验群间比较试验。以早晩各2粒、1天4粒的方式自月经开始前10~7天起连续7天摄取被试验物,该被试验物包含γ-生育酚90mg的软胶囊(即,γ-生育酚的单日量为360mg)或安慰剂胶囊。评价时段是自连续摄取第6天的早晨开始至摄取结束后第8天的早晨截止,在每餐前实施问卷调查评价,求出相对于评价开始时的变化量的平均值,借此与安慰剂群进行比较。
问卷调查评价是借由VAS(Visual Analog Scale(视觉模拟量表))及MDQ(Menstrual Distress Questionnarie(月经伴随症状问卷调查))进行。各提问项目示于表1及表2。
再者,VAS是请被试验者针对各提问,在「0mm」(无症状)~「100mm」(症状非常明显/影响日常生活)的标度范围内标示症状,求出相对于评价开始时的变化量的平均值,借此算出。MDQ是请被试验者针对各提问,在「0」(无症状)~「5」(症状非常明显/影响日常生活)6个阶段间作答,分为表2所示的8个类别,算出总分。
[表1]
[表2]
试验例1的结果1:VAS
将γ-生育酚单独试验的结果示于图1。γ-生育酚单独试验显示与安慰剂相比得分减小的人的比率。借由单独摄取γ-生育酚,在γ-生育酚服用群中,与安慰剂相比,不仅足部浮肿等身体不快症状得到改善,且「焦躁、易怒」等精神不快症状还得到显著改善。
试验例1的结果2:MDQ
根据γ-生育酚单独试验,γ-生育酚服用群中的与安慰剂相比得分减小的人的比率如下:「水分蓄积」项目为56.0%、「疼痛」项目为44.0%、「负向情绪」项目为28.0%、「集中力」为36.0%、「行为变化」为32.0%,表现出较高的改善率。
由此表明,借由单独服用γ-生育酚,不仅改善「水分蓄积」或「疼痛」等身体症状,且还改善「焦躁、易怒」或「负向情绪」「集中力」「行为变化」等精神症状。
试验例2:γ-生育酚与雌马酚并用试验
以25名在月经前有某些不快症状者作为对象,以1天1次的方式自预计月经开始前10~7天起连续7天摄取被试验物(单日量如下:含有γ-生育酚360mg的软胶囊1粒、与含有包含雌马酚1mg的大豆胚轴酦酵物、铁2mg及钙125mg的锭剂2粒(即,雌马酚、铁及钙的单日量分别为2mg、4mg及250mg))。
在被试验物摄取前、及连续7天摄取结束后,借由MDQ评价月经前的症状。MDQ如试验例1的记载。另外,按「症状得到前所未有的减轻」、「无变化」、「恶化」3个阶段评价生理前与生理中的整体改善度。进而,针对被试验物摄取前后的月经前的症状、及连续摄取结束后的月经期间的症状,进行问卷调查。
试验例2的结果1:MDQ
对25名中的11名,在月经前实施MDQ,算出与被试验物摄取前相比摄取后的得分减小的人的比率。关于剩余的14名,由于中途月经开始,故而无法在月经前实施MDQ。
若服用包含γ-生育酚与雌马酚的被试验物,则与摄取前相比得分减小的人的比率如下:「水分蓄积」项目为54.5%、「疼痛」项目为63.6%、「负向情绪」项目为60.0%、「集中力」项目为54.5%、「行为变化」项目为60.0%。
图2显示试验例1的结果2与试验例2的结果1的MDQ的比较。尤其关于「疼痛」、「负向情绪」、「集中力」及「行为变化」4个类别,相较于单独给予γ-生育酚的情形,组合给予γ-生育酚与雌马酚的情形时症状得到改善的人的比率增加。另外,试验例1与试验例2的结果还提示单独给予雌马酚时还对于「疼痛」、「负向情绪」、「集中力」、「行为变化」有效果。
试验例2的结果2:整体改善度
由25名被试验者,按「症状得到前所未有的减轻」、「无变化」、「恶化」3个阶段评价借由摄取被试验物而实现的生理前及生理中症状的整体改善度。将结果示于图3。根据图3可知,在组合摄取γ-生育酚与雌马酚的情形时,半数以上(生理前68.0%、生理中52.0%)的被试验者在生理前及生理中的不快症状得到改善。
试验例2的结果3:问卷调查结果
根据问卷调查的结果,还存在如下回答:在生理前、生理中的皮肤粗糙现象消失,在生理前必定出现的痤疮不再出现。
由此可知,借由组合摄取γ-生育酚与雌马酚,相较于单独摄取γ-生育酚而更显示出针对女性特有的身体和/或精神不快症状、尤其月经前和/或月经中的身体不快症状和/或精神不快症状的症状改善作用。
Claims (5)
1.将γ-生育酚及雌马酚用于制备一种女性特有的身体和/或精神不快症状的改善剂中的应用,γ-生育酚与雌马酚的调配比率以总量的重量比计为1:0.002~1:0.3,
其中上述女性特有的身体和/或精神不快症状为选自由疼痛、负向情绪、集中力、及行为变化所组成的群中的一种以上,
其中女性特有的身体和/或精神不快症状为月经前和/或月经中的身体和/或精神不快症状。
2.如权利要求1的应用,其以个别剂的形式分别包含γ-生育酚与雌马酚。
3.如权利要求1的应用,其以同一剂的形式包含γ-生育酚与雌马酚。
4.如权利要求1至3中任一项的应用,其是用以使γ-生育酚的单日摄取量成为0.1~1000mg、及雌马酚的单日摄取量成为0.1~50mg而摄取。
5.如权利要求1至4中任一项的应用,改善剂为饮食品的形式。
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