TW201731503A - 女性特有之身體及/或精神不快症狀之改善劑 - Google Patents
女性特有之身體及/或精神不快症狀之改善劑 Download PDFInfo
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Abstract
本發明提供一種女性特有之身體及/或精神不快症狀之改善效果較高、且能夠方便地進行攝取之類型之改善劑。本發明提供一種包含γ -生育酚及/或雌馬酚之女性特有之身體及/或精神不快症狀之改善劑。
Description
本發明係關於一種女性特有之身體及/或精神不快症狀之改善劑。
所謂女性特有之身體及/或精神不快症狀係被認為一原因為女性激素等之變動等之不快症狀。女性特有之身體及/或精神不快症狀包括:月經前之身體及/或精神不快症狀(亦稱為月經前症候群「PMS」)、及包括生理痛之月經中之身體及/或精神不快症狀、以及由生理不暢、子宮異常出血、自律神經失調症、不孕、更年期障礙等引起之不快症狀。
例如PMS主要持續於月經前3~10天之間,隨著月經開始而症狀減輕或消失。作為原因之一,可列舉雌激素(卵胞激素)及孕酮(黃體激素)之急遽減少,但認為亦存在其他多個因素,PMS之原因尚未明確。作為PMS之症狀,可列舉:困倦、腰痛、下腹部痛、頭痛、易疲勞、肩酸、浮腫、乳房脹痛、眩暈、皮膚粗糙、座瘡、憂慮、不安、倦怠感、無力、集中力低下、焦躁等各種症狀。
又,月經中之身體及/或精神不快症狀表現為下腹部痛、腰痛、頭痛等身體疼痛、全身感覺倦怠或倦乏等莫名之不舒服、焦躁、無力、憂慮、易怒、噁心、胃痛、食慾不振、下痢、眩暈等各種症狀。月經中之身體及/或精神不快症狀之原因亦尚未明確,認為亦由多個因素引起。
關於女性特有之身體及/或精神不快症狀之治療或預防,由於其原因不確定、或個體間症狀之特徵或期間存在差異,故而一般採用對症療法、或藉由改善飲食、養成運動習慣、消除壓力等自我管理而緩和症狀之方法。
例如關於PMS之對症療法,對多種成分進行了有效性研究,報告有包含大豆異黃酮苷元、尤其大豆黃酮(daidzein)之PMS治療劑(專利文獻1)。進而,針對由大豆黃酮代謝生成之雌馬酚(equol)對PMS之影響進行了研究(非專利文獻1)。又,已知使用γ -生育酚以改善浮腫等水分蓄積症狀。
[專利文獻1]日本專利特開2003-300879號公報
[非專利文獻1]東京醫療保健大學紀要,第1號2006年,第39-42頁
多數女性均有過女性特有之身體及/或精神不快症狀之體驗,嚴重時甚至會影響日常生活。另一方面,女性之社會參與率提昇,能夠方便地於外出途中等進行攝取之類型之女性特有之身體及/或精神不快症狀之改善劑受到期待。然而,業界尚未開發出女性特有之身體及/或精神不快症狀之改善效果較高、且能夠方便地進行攝取之類型之改善劑。
基於上述狀況,本發明者等人為了開發出能夠方便地進行攝取之類型之女性特有之身體及/或精神不快症狀改善劑,進行了努力研究。其結果發現,藉由組合投予γ -生育酚及/或雌馬酚而顯著改善女性特有之身體及/或精神不快症狀、例如月經前及/或月經中之身體及/或精神不快症狀,從而完成了本發明。
即,本發明提供[1]一種女性特有之身體及/或精神不快症狀之改善劑,其包含γ -生育酚及雌馬酚;[2]如[1]記載之改善劑,其以個別劑之形式分別包含γ -生育酚與雌馬酚;[3]如[1]記載之改善劑,其以同一劑之形式包含γ -生育酚與雌馬酚;[4]如[1]至[3]中任一項記載之改善劑,其中上述女性
特有之身體及/或精神不快症狀為選自由疼痛、負向情緒、集中力、及行為變化所組成之群中之一種以上;[5]如[1]至[4]中任一項記載之改善劑,其中上述女性特有之身體及/或精神不快症狀為月經前及/或月經中之身體及/或精神不快症狀;[6]如[1]至[5]中任一項記載之改善劑,其中γ -生育酚與雌馬酚之調配比率(總量之重量比)為1:0.0001~1:500;[7]如[1]至[6]中任一項記載之改善劑,其含有含雌馬酚之大豆胚軸醱酵物作為雌馬酚;[8]如[1]至[7]中任一項記載之改善劑,其係用以使γ -生育酚之單日攝取量成為0.1~1000mg、及雌馬酚之單日攝取量成為0.1~50mg而攝取;[9]一種飲食品,其包含如[1]至[8]中任一項記載之改善劑;[10]如[1]至[8]中任一項記載之改善劑,其為飲食品之形態;[11]一種女性特有之身體及/或精神不快症狀之改善劑,其包含γ -生育酚;[12]如[11]記載之改善劑,其中女性特有之身體及/或精神不快症狀為選自由疼痛、負向情緒、集中力、及行為變化所組成之群中之一種以上;[13]如[11]或[12]記載之改善劑,其中女性特有之身體及/或精神不快症狀為月經前及/或月經中之身體及/或精神
不快症狀;[14]如[11]至[13]中任一項記載之改善劑,其係用以使γ -生育酚之單日攝取量成為0.1~1000mg而攝取;[15]一種飲食品,其包含如[11]至[14]中任一項記載之改善劑;[16]如[11]至[14]中任一項記載之改善劑,其為飲食品之形態;[17]一種女性特有之身體及/或精神不快症狀之改善劑,其包含雌馬酚;[18]如[17]記載之改善劑,其中女性特有之身體及/或精神不快症狀為選自由疼痛、負向情緒、集中力、及行為變化所組成之群中之一種以上;[19]如[17]或[18]記載之改善劑,其中女性特有之身體及/或精神不快症狀為月經前及/或月經中之身體及/或精神不快症狀;[20]如[17]至[19]中任一項記載之改善劑,其含有含雌馬酚之大豆胚軸醱酵物作為雌馬酚;[21]如[17]至[20]中任一項記載之改善劑,其係用以使雌馬酚之單日攝取量成為0.1~50mg而攝取;[22]一種飲食品,其包含如[17]至[21]中任一項記載之改善劑;以及[23]如[17]至[21]中任一項記載之改善劑,其為飲食品之形態。
本發明發揮以下之1個以上之效果。
(1)可提供一種女性特有之身體及/或精神不快症狀之改善劑(以下稱為「本發明之改善劑」)。
(2)尤其可提供一種月經前及/或月經中之身體及/或精神不快症狀之改善劑。
(3)可提供一種能夠方便地進行攝取之類型之本發明之改善劑。
第1圖表示γ -生育酚單獨試驗時之VAS之結果。圖中,「γ -Toc」意指γ -生育酚。
第2圖表示γ -生育酚單獨試驗、及γ -生育酚與雌馬酚併用試驗之MDQ之結果。圖中之「γ Toc」意指γ -生育酚。
第3圖表示γ -生育酚與雌馬酚併用試驗之整體改善度之結果。
所謂「γ -生育酚」係大豆油或菜籽油等植物油中所含之一種天然維生素E。已知維生素E具有防止體內脂肪氧化之優異之抗氧化作用。本發明中使用之γ -生育酚並無特別限定。例如可使用作為製藥用或食品用原材料而市售之γ -生育酚。
本發明中,γ -生育酚之每日攝取量取決於所欲改善之症狀之程度,例如為0.1~1000mg,較佳為50
~800mg,更佳為60~450mg。本發明之改善劑所含之γ -生育酚之量可考慮到本發明之改善劑之形狀等,於上述γ -生育酚之每日攝取量之範圍內適當決定。只要以達到上述每日攝取量之方式攝取1個~複數個本發明之改善劑即可。
所謂「雌馬酚」係主要以與糖結合之配糖體之形式存在之異黃酮類經體內之消化酵素或腸內細菌所產生之酵素等轉化後產生之代謝物,具有較高之雌激素活性。本發明中使用作為選自由大豆黃酮配糖體、大豆黃酮及二氫大豆黃酮所組成之群中之至少一種大豆黃酮類之代謝物的雌馬酚。作為大豆黃酮配糖體,例如可列舉:大豆苷(daidzin)、丙二醯大豆苷、乙醯大豆苷等。本發明中使用之雌馬酚並無特別限定,可為藉由合成法所得者,或亦可為藉由醱酵法所得者。
本發明中,亦可使用含有雌馬酚之大豆胚軸醱酵物(以下稱為「含雌馬酚之大豆胚軸醱酵物」。含雌馬酚之大豆胚軸醱酵物係藉由利用具有將選自由大豆黃酮配糖體、大豆黃酮及二氫大豆黃酮所組成之群中之至少一種大豆黃酮類同化而產生雌馬酚之能力的微生物,使大豆胚軸醱酵而獲得。已知所謂大豆胚軸係於大豆發芽時成為幼芽、幼根之部分,包含大量之大豆黃酮配糖體或大豆黃酮等大豆黃酮類。本發明中使用之大豆胚軸只要為含有大豆黃酮類者則均可,關於大豆之種類、產地或加工之有無、大豆胚軸之形狀等並無限制。例如可為原始狀態者,自經
過加熱處理、乾燥處理或蒸煮處理等之大豆所分離出者,將自未加工之大豆所分離出之胚軸供於加熱處理、乾燥處理或蒸煮處理等所得者,經脫脂處理或脫蛋白處理者,粉末狀、或經粉碎或破碎者。作為上述具有產生雌馬酚之能力之微生物,只要為食品衛生上所容許、且具有雌馬酚產生能力,則並無特別限制,例如可列舉:格氏乳球菌(Lactococcus garvieae)等屬於乳球菌屬之微生物、中間鏈球菌(Streptococcus intermedius)、星群鏈球菌(Streptococcus constellatus)等屬於鏈球菌屬之微生物、卵形擬桿菌(Bacteroides ovatus)等屬於擬桿菌屬之微生物。上述具有產生雌馬酚之能力之微生物亦可例如以雌馬酚產生能力作為指標而自人類糞便中進行單離。進而,亦可使用如下由申請人單離並鑑定之寄存菌:乳球菌20-92(FERM BP-10036)、鏈球菌E-23-17(FERM BP-6436)、鏈球菌A6G225(FERM BP-6437)及擬桿菌E-23-15(FERM BP-6435)。含有雌馬酚之大豆胚軸醱酵物可藉由使用上述具有產生雌馬酚之能力之微生物,使上述大豆胚軸於適當條件下醱酵而獲得。只要可產生雌馬酚,則醱酵條件並無特別限制,由業者適當決定。例如可使用藉由國際公開第WO2007/066655號所記載之方法而獲得之含雌馬酚之大豆胚軸醱酵物。
含雌馬酚之大豆胚軸醱酵物除包含雌馬酚以外,亦包含大豆苷、丙二醯大豆苷、乙醯大豆苷、大豆黃酮、二氫大豆黃酮等大豆黃酮類、金雀異黃苷(genistin)、丙二醯金雀異黃苷、乙醯金雀異黃苷、金雀異黃酮
(genistein)、二氫金雀異黃酮等金雀異黃酮類、黃豆黃苷(Glycitin)、丙二醯黃豆黃苷、乙醯黃豆黃苷、黃豆黃素(Glycitein)、二氫黃豆黃素等黃豆黃素類等各種異黃酮,從而亦可表現出該等異黃酮之有用生理活性。進而,含雌馬酚之大豆胚軸醱酵物亦包含源自大豆胚軸之皂苷,從而亦可表現出皂苷之有用生理活性(例如抗病毒活性等)。因此,於本發明之改善劑含有含雌馬酚之大豆胚軸醱酵物之情形時,可期待附加效果。含雌馬酚之大豆胚軸醱酵物其雌馬酚以外之異黃酮類之組成亦與大豆胚軸中之組成不同。尤其大豆胚軸醱酵物中之擔憂作為內分泌擾亂物質發揮作用之金雀異黃酮類之含有比率較低。
關於本發明中使用之含雌馬酚之大豆胚軸醱酵物,每1g(乾燥重量)該大豆胚軸醱酵物中,含有雌馬酚例如1~20mg、較佳為2~12mg,含有大豆黃酮類以總量計例如0.1~30mg、較佳為0.1~1.5mg,含有金雀異黃酮類以總量計例如0.05mg~2.5mg、較佳為0.05~2mg,及含有黃豆黃素類以總量計例如0.1~4mg、較佳為2~3.5mg。又,關於含雌馬酚之大豆胚軸醱酵物中之各異黃酮之組成比率,以相對於該大豆胚軸醱酵物所含之全部異黃酮之合計重量的比率計,雌馬酚例如為30~75重量%、較佳為40~70重量%、更佳為45~70重量%,大豆黃酮類例如為1~20重量%、較佳為2~15重量%、更佳為4~12重量%,金雀異黃酮類例如為0.1~20重量%、較佳為1~15重量%、更佳為1~10重量%,黃豆黃素類例如為10~50重
量%、較佳為15~35重量%、更佳為25~35重量%。又,關於含雌馬酚之大豆胚軸醱酵物中之皂苷含量,每1g(乾燥重量)該大豆胚軸醱酵物中例如為10~80mg、較佳為20~50mg、更佳為30~40mg。
上述具有產生雌馬酚之能力之微生物中亦存在具有將精胺酸轉化為鳥胺酸之能力者,可自格氏乳球菌中進行選擇。例如可列舉乳球菌20-92(FERM BP-10036)。於使用此種微生物而使大豆胚軸醱酵之情形時,藉由對該大豆胚軸添加精胺酸而進行醱酵,可使所獲得之含雌馬酚之大豆胚軸醱酵物中含有鳥胺酸。關於此種含雌馬酚之大豆胚軸醱酵物中之鳥胺酸含量,每1g(乾燥重量)該大豆胚軸醱酵物中例如為0.5~2mg,較佳為8~15mg,更佳為9~12mg。此種含雌馬酚之大豆胚軸醱酵物亦可表現出基於鳥胺酸之有用生理活性。
本發明中,於使用含雌馬酚之大豆胚軸醱酵物之情形時,該含雌馬酚之大豆胚軸醱酵物可直接以醱酵後之狀態使用,或亦可視需要供於加熱處理而成為乾燥固形物狀後使用。就保存穩定性之觀點而言,含雌馬酚之大豆胚軸醱酵物較佳為藉由加熱乾燥處理而成為固形狀。又,經加熱乾燥處理之含雌馬酚之大豆胚軸醱酵物視需要亦可供於粉末化處理而成為粉末狀。
本發明中,雌馬酚之每日攝取量取決於所欲改善之症狀之程度,例如為0.1~50mg,較佳為0.5~30mg,更佳為1~20mg。本發明之改善劑所含之雌馬酚之量
可考慮到本發明之改善劑之形狀等,於上述雌馬酚之每日攝取量之範圍內適當決定。只要以達到上述每日攝取量之方式攝取1個~複數個本發明之改善劑即可。
本發明中,含雌馬酚之大豆胚軸醱酵物之每日量取決於所欲改善之症狀或該大豆胚軸醱酵物中之雌馬酚含量,例如為0.005~5g,較佳為0.025~30g,更佳為1~20g。
包含γ -生育酚及雌馬酚之本發明之改善劑所含之γ -生育酚與雌馬酚之調配比率(總量之重量比)並無特別限定,例如為1:0.0001~1:500,較佳為1:0.0006~1:0.6,更佳為1:0.002~1:0.3。
本發明之改善劑亦可包含無損女性特有之身體及/或精神不快症狀之改善效果的其他成分。作為其他成分,例如可適當調配維生素、礦物質(例如鉀、鈣、鎂、鐵、鋅等)等營養強化劑,乳糖、澱粉、纖維素、麥芽糖醇及糊精等賦形劑,甘油脂肪酸酯及蔗糖脂肪酸酯等界面活性劑,明膠、蟲膠及玉米蛋白等被膜劑,小麥胚芽油、米胚芽油及葵花籽油等油脂類,蜂蠟、米糠蠟等蠟類,蔗糖、葡萄糖、果糖、甜菊、糖精及蔗糖素等甜味劑,以及檸檬酸、蘋果酸及葡萄糖酸等酸味劑等。
本發明之改善劑亦可進而包含溶劑、分散劑、乳化劑、穩定化劑、緩衝劑、增量劑、黏合劑、崩散劑、潤滑劑等各種添加劑。
於本發明之改善劑包含鈣之情形時,鈣量
並無特別限定,作為鈣之每日攝取量,例如為0.1~2500mg,較佳為50~650mg,更佳為100~300mg。本發明之改善劑所含之鈣量可於上述鈣之每日攝取量之範圍內適當決定。
於本發明之改善劑包含鐵之情形時,鐵量並無特別限定,作為鐵之每日攝取量,例如為0.1~40mg,較佳為0.2~15mg,更佳為0.5~10mg。典型而言,於本發明中,鐵之每日攝取量約為4mg。本發明之改善劑所含之鐵量可於上述鐵之每日攝取量之範圍內適當決定。
本發明之改善劑可用作醫藥、各種飲食品或食品用組成物,並無限定。此處,所謂食品用組成物意指用以製造飲食品之飲食品用原材料、食品添加劑等。本發明之改善劑亦可用作功能性表現食品、特定保健用食品、健康食品、營養輔助食品(補充品)、醫療用食品等飲食品。
作為本發明之改善劑之形狀,可採用通常之醫藥或飲食品之形態。例如可列舉:錠劑、顆粒劑、膠囊劑(例如軟膠囊劑或硬膠囊劑)、粉末劑、液劑、懸浮劑、發泡劑、咀嚼錠、點心類(例如曲奇、餅乾、巧克力點心、薯片、蛋糕、口香糖、糖果、軟糖、饅頭、羊羹、布丁、果凍、酸乳酪、冰淇淋、雪酪等)、麵包、麵條類、米飯類、系列食品、飲料(例如清涼飲料、碳酸飲料、營養飲料、粉末飲料、果肉飲料、乳飲料、果凍飲料等)、湯(例如粉末湯、冷凍乾燥即時濃湯、罐頭湯等)、味噌汁(例如粉末味
噌汁、冷凍乾燥即時味噌汁等)等。本發明之改善劑可藉由常規方法製成上述任一種形狀。
於包含γ -生育酚及雌馬酚之本發明之改善劑中,γ -生育酚及雌馬酚可以個別劑之形式分別包含,亦可以同一劑之形式包含。
於包含γ -生育酚及雌馬酚之本發明之改善劑中以個別劑之形式分別包含γ -生育酚及雌馬酚之情形時,各劑可為具有相同形狀者,或亦可為具有不同形狀者。例如包含γ -生育酚及雌馬酚之本發明之改善劑可含有包含γ -生育酚之膠囊劑與包含雌馬酚之錠劑的組合。或者包含γ -生育酚及雌馬酚之本發明之改善劑亦可為包含γ -生育酚之錠劑與包含雌馬酚之錠劑的組合,亦可為包含γ -生育酚與雌馬酚之錠劑。又,包含γ -生育酚及雌馬酚之本發明之改善劑亦可為一併包含γ -生育酚及雌馬酚之飲食品。
本發明之改善劑包括:包含γ -生育酚作為有效成分之改善劑、包含雌馬酚作為有效成分之改善劑、及包含γ -生育酚與雌馬酚作為有效成分之改善劑。藉由將γ -生育酚與雌馬酚併用,而於可同時享有該兩種有效成分之效果方面較為有利。
本發明之改善劑例如1天攝取1次~數次。本發明之改善劑之攝取期間並無特別限定,例如可數天間~數週間進行攝取,亦可1月間~數月間進行攝取。例如於自月經前至月經結束時之期間,可於出現不快症狀時進
行攝取,或亦可於出現不快症狀之前進行預防性攝取。本發明之改善劑於上述攝取期間內可間斷地或連續地攝取。
關於本發明之改善劑之攝取量,只要可獲取各成分之單日攝取量,則並無特別限定。於本發明之改善劑包含γ -生育酚及雌馬酚、且γ -生育酚及雌馬酚係以個別劑之形式分別包含之情形時,包含γ -生育酚之劑與包含雌馬酚之劑可同時攝取,或亦可於時間上隔開間隔地分別攝取。
本發明之改善劑之包裝形態並無特別限定,只要以醫藥或飲食品通常所用之形態進行包裝即可。例如可列舉利用PTP(polyterephthalate,聚對苯二甲酸酯)片材、鋁箔、各種膜、箱、袋、PET瓶、罐、瓶、紙袋等之包裝。其中,為了能夠方便地進行攝取,較佳為可攜帶類型之包裝形態。例如於包含γ -生育酚及雌馬酚之本發明之改善劑中以個別劑之形式分別包含γ -生育酚及雌馬酚之情形時,各劑可分別包裝,或亦可一併包裝。本發明之改善劑較佳為以內裝單日量之各成分之方式包裝1種劑或一併包裝複數種劑。進而,亦可將含有單日量之各成分之包裝物以包含複數個、例如1~數週之份量之方式進行包裝。
例如包含γ -生育酚及雌馬酚之本發明之改善劑可將包含γ -生育酚之膠囊劑1粒與包含雌馬酚之錠劑2粒設為一組而作為單日量包裝於1個袋內。進而,例如可將內裝有上述一組之袋以7天份(7袋)包裝於單個包
裝(例如箱)內,或亦可以30天份(30袋)包裝於單個包裝內。或者作為包含γ -生育酚及雌馬酚之飲食品之形態,可包裝於能夠攜帶相當於γ -生育酚及雌馬酚之單日攝取量之量的包裝內。
本發明之改善劑所改善之所謂「女性特有之身體及/或精神不快症狀」係認為一原因為女性激素等之變動等之各種不快症狀,包括:月經前症候群(「PMS」)、及包括生理痛之月經中之身體及/或精神不快症狀、以及由生理不暢、子宮異常出血、自律神經失調症、不孕、更年期障礙等引起之不快症狀。具體而言,例如可列舉:困倦、腰痛、下腹部痛、頭痛、易疲勞、肩酸、浮腫、乳房脹痛、眩暈、皮膚粗糙、座瘡、憂慮、不安、倦怠感、無氣力、集中力低下、焦躁感、易怒、噁心、胃痛、食慾不振、下痢等不快症狀。
進而,亦可將本發明之改善劑所改善之「女性特有之身體及/或精神不快症狀」之主要症狀大體分為水分蓄積、負向情緒、疼痛、集中力、及行動力之變化。此處,所謂「水分蓄積」意指體重增加、皮膚粗燥(例如痤瘡)、乳房脹痛、浮腫(腹部、乳房、足部)等各種症狀。所謂「負向情緒」意指想哭、感覺空寂、感覺不安、心緒不寧、焦躁、易怒、情緒不穩、感覺憂慮、易緊張等各種症狀。所謂「疼痛」意指肩部或頸部酸痛、頭痛、下腹部痛、腰痛、易疲勞、身體痛等症狀。所謂「集中力」意指失眠、健忘、思想不集中、判斷力遲鈍、集中力下降、精神渙散、意想
不到地失敗、動作遲鈍等相關症狀。所謂「行動力之變化」意指對學習或工作失去毅力、打瞌睡、悶局家中、躲避人際交往、學習或工作之效率低下等。
又,本發明提供一種女性特有之身體及/或精神不快症狀之改善方法,其特徵在於投予γ -生育酚及雌馬酚。進而,作為另一態樣,本發明提供一種γ -生育酚及雌馬酚之用途,其用於改善女性特有之身體及/或精神不快症狀。又,作為另一態樣,本發明提供一種γ -生育酚及雌馬酚之用途,其用於製造女性特有之身體及/或精神不快症狀之改善劑。
本發明中,所謂「改善」包括上述不快症狀之減輕、預防及治療。因此,本發明亦提供一種女性特有之身體及/或精神不快症狀之減輕、預防及/或治療劑,其包含γ -生育酚及雌馬酚。進而,本發明提供一種女性特有之身體及/或精神不快症狀之減輕、預防及/或治療方法,其特徵在於投予γ -生育酚及雌馬酚。進而,作為另一態樣,本發明提供一種γ -生育酚及雌馬酚之用途,其用於減輕、預防及/或治療女性特有之身體及/或精神不快症狀。又,作為另一態樣,本發明提供一種γ -生育酚及雌馬酚之用途,其用於製造女性特有之身體及/或精神不快症狀之減輕、預防及/或治療劑。
進而,本發明中發現,γ -生育酚不僅具有水分蓄積改善效果,且亦改善疼痛、負向情緒、集中力、及行為變化等之身體及/或精神不快症狀。因此,本發明提
供一種女性特有之身體及/或精神不快症狀之改善劑,其包含γ -生育酚;提供一種女性特有之身體及/或精神不快症狀之改善方法,其特徵在於投予γ -生育酚;提供一種γ -生育酚之用途,其用於改善女性特有之身體及/或精神不快症狀;及提供一種γ -生育酚之用途,其用於製造女性特有之身體及/或精神不快症狀之改善劑。進而,作為另一態樣,本發明提供一種女性特有之身體及/或精神不快症狀之減輕、預防及/或治療劑,其包含γ -生育酚;提供一種女性特有之身體及/或精神不快症狀之減輕、預防及/或治療方法,其特徵在於投予γ -生育酚;提供一種γ -生育酚之用途,其用於減輕、預防及/或治療女性特有之身體及/或精神不快症狀;提供一種γ -生育酚之用途,其用於製造女性特有之身體及/或精神不快症狀之減輕、預防及/或治療劑。
進而,本發明中發現,雌馬酚亦改善疼痛、負向情緒、集中力、及行為變化等身體及/或精神不快症狀。因此,本發明提供一種女性特有之身體及/或精神不快症狀之改善劑,其包含雌馬酚;提供一種女性特有之身體及/或精神不快症狀之改善方法,其特徵在於投予雌馬酚;提供一種雌馬酚之用途,其用於改善女性特有之身體及/或精神不快症狀;及提供一種雌馬酚之用途,其用於製造女性特有之身體及/或精神不快症狀之改善劑。進而,作為另一態樣,本發明提供一種女性特有之身體及/或精神不快症狀之減輕、預防及/或治療劑,其包含雌馬酚;提供一種
女性特有之身體及/或精神不快症狀之減輕、預防及/或治療方法,其特徵在於投予雌馬酚;提供一種雌馬酚之用途,其用於減輕、預防及/或治療女性特有之身體及/或精神不快症狀;提供一種雌馬酚之用途,其用於製造女性特有之身體及/或精神不快症狀之減輕、預防及/或治療劑。
於本說明書中,除特別定義或說明之用語以外之用語可以醫藥品或食品領域中通常採用之含義進行解釋。
以下,揭示實施例而說明本發明,但本發明並不限定於該等實施例。實施例所示之調配量為每個製劑之調配量。
實施例1:軟膠囊+錠劑
使用適量之膠囊基劑、賦形劑等,藉由常規方法製作如下製劑:含有γ -生育酚360mg之軟膠囊、以及含有包含雌馬酚1mg之大豆胚軸醱酵物及鈣125mg之錠劑。再者,含雌馬酚之大豆胚軸醱酵物係藉由國際公開第WO2007/066655號所記載之方法而製造。將膠囊1粒及錠劑2粒設為一組。
試驗例1:γ -生育酚單獨試驗
以25名於月經前存在水分蓄積者作為對象,實施隨機分組安慰劑對照二重盲檢試驗群間比較試驗。以早晚各2粒、1天4粒之方式自月經開始前10~7天起連續7天攝取被試驗物,該被試驗物包含γ -生育酚90mg之軟膠囊
(即,γ -生育酚之單日量為360mg)或安慰劑膠囊。評價時段係自連續攝取第6天之早晨開始至攝取結束後第8天之早晨截止,於每餐前實施問卷調查評價,求出相對於評價開始時之變化量之平均值,藉此與安慰劑群進行比較。
問卷調查評價係藉由VAS(Visual Analog Scale(視覺類比量表))及MDQ(Menstrual Distress Questionnarie(月經伴隨症狀問卷調查))進行。各提問項目示於表1及表2。再者,VAS係請被試驗者針對各提問,於「0mm」(無症狀)~「100mm」(症狀非常明顯/影響日常生活)之標度範圍內標示症狀,求出相對於評價開始時之變化量之平均值,藉此算出。MDQ係請被試驗者針對各提問,於「0」(無症狀)~「5」(症狀非常明顯/影響日常生活)6個階段間作答,分為表2所示之8個類別,算出總分。
試驗例1之結果1:VAS
將γ -生育酚單獨試驗之結果示於第1圖。γ -生育酚單獨試驗顯示與安慰劑相比得分減小之人之比率。藉由單獨攝取γ -生育酚,於γ -生育酚服用群中,與安慰劑相比,不僅足部浮腫等身體不快症狀得到改善,且「焦躁、易怒」等精神不快症狀亦得到顯著改善。
試驗例1之結果2:MDQ
根據γ -生育酚單獨試驗,γ -生育酚服用群中之與安慰劑相比得分減小之人之比率如下:「水分蓄積」項目為56.0%、「疼痛」項目為44.0%、「負向情緒」項目為28.0%、「集中力」為36.0%、「行為變化」為32.0%,表現出較高之改善率。
由此表明,藉由單獨服用γ -生育酚,不僅改善「水分蓄積」或「疼痛」等身體症狀,且亦改善「焦躁、易怒」或「負向情緒」「集中力」「行為變化」等精神症狀。
試驗例2:γ -生育酚與雌馬酚併用試驗
以25名於月經前有某些不快症狀者作為對象,以1天1次之方式自預計月經開始前10~7天起連續7天攝取被試驗物(單日量如下:含有γ -生育酚360mg之軟膠囊1粒、與含有包含雌馬酚1mg之大豆胚軸醱酵物、鐵2mg及鈣125mg之錠劑2粒(即,雌馬酚、鐵及鈣之單日量分別為2mg、4mg及250mg))。
於被試驗物攝取前、及連續7天攝取結束後,藉由MDQ評價月經前之症狀。MDQ如試驗例1之記載。又,按「症狀得到前所未有之減輕」、「無變化」、「惡化」3個階段評價生理前與生理中之整體改善度。進而,針對被試驗物攝取前後之月經前之症狀、及連續攝取結束後之月經期間之症狀,進行問卷調查。
試驗例2之結果1:MDQ
對25名中之11名,於月經前實施MDQ,算出與被試驗物攝取前相比攝取後之得分減小之人之比率。關於剩餘之14名,由於中途月經開始,故而無法於月經前實施MDQ。
若服用包含γ -生育酚與雌馬酚之被試驗物,則與攝取前相比得分減小之人之比率如下:「水分蓄積」項目為54.5%、「疼痛」項目為63.6%、「負向情緒」項目為60.0%、「集中力」項目為54.5%、「行為變化」項目為60.0%。
第2圖顯示試驗例1之結果2與試驗例2之結果1之MDQ之比較。尤其關於「疼痛」、「負向情緒」、「集中力」及「行為變化」4個類別,相較於單獨投予γ -生育酚之情形,組合投予γ -生育酚與雌馬酚之情形時症狀得到改善之人之比率增加。又,試驗例1與試驗例2之結果亦提示單獨投予雌馬酚時亦對於「疼痛」、「負向情緒」、「集中力」、「行為變化」有效果。
試驗例2之結果2:整體改善度
由25名被試驗者,按「症狀得到前所未有之減輕」、「無變化」、「惡化」3個階段評價藉由攝取被試驗物而實現之
生理前及生理中症狀之整體改善度。將結果示於第3圖。根據第3圖可知,於組合攝取γ -生育酚與雌馬酚之情形時,半數以上(生理前68.0%、生理中52.0%)之被試驗者於生理前及生理中之不快症狀得到改善。
試驗例2之結果3:問卷調查結果
根據問卷調查之結果,亦存在如下回答:於生理前、生理中之皮膚粗糙現象消失,於生理前必定出現之座瘡不再出現。
由此可知,藉由組合攝取γ -生育酚與雌馬酚,相較於單獨攝取γ -生育酚而更顯示出針對女性特有之身體及/或精神不快症狀、尤其月經前及/或月經中之身體不快症狀及/或精神不快症狀的症狀改善作用。
本案圖式皆為表示試驗結果之圖表,不足以代表本案之技術特徵。故本案無指定代表圖。
Claims (21)
- 一種女性特有之身體及/或精神不快症狀之改善劑,其包含γ -生育酚及雌馬酚。
- 如申請專利範圍第1項所述之改善劑,其以個別劑之形式分別包含γ -生育酚與雌馬酚。
- 如申請專利範圍第1所述之改善劑,其以同一劑之形式包含γ -生育酚與雌馬酚。
- 如申請專利範圍第1至3項中任一項所述之改善劑,其中上述女性特有之身體及/或精神不快症狀為選自由疼痛、負向情緒、集中力、及行為變化所組成之群中之一種以上。
- 如申請專利範圍第1至4項中任一項所述之改善劑,其中女性特有之身體及/或精神不快症狀為月經前及/或月經中之身體及/或精神不快症狀。
- 如申請專利範圍第1至5項中任一項所述之改善劑,其中γ -生育酚與雌馬酚之調配比率(總量之重量比)為1:0.0001~1:500。
- 如申請專利範圍第1至6項中任一項所述之改善劑,其係用以使γ -生育酚之單日攝取量成為0.1~1000mg、及雌馬酚之單日攝取量成為0.1~50mg而攝取。
- 一種飲食品,其包含如申請專利範圍第1至7項中任一項所述之改善劑。
- 如申請專利範圍第1至7項中任一項所述之改善劑,其為飲食品之形態。
- 一種女性特有之身體及/或精神不快症狀之改善劑,其包含γ -生育酚。
- 如申請專利範圍第10項所述之改善劑,其中上述女性特有之身體及/或精神不快症狀為選自由疼痛、負向情緒、集中力、及行為變化所組成之群中之一種以上。
- 如申請專利範圍第10或11項所述之改善劑,其中上述女性特有之身體及/或精神不快症狀為月經前及/或月經中之身體及/或精神不快症狀。
- 如申請專利範圍第10至12項中任一項所述之改善劑,其係用以使γ -生育酚之單日攝取量成為0.1~1000mg而攝取。
- 一種飲食品,其包含如申請專利範圍第10至13項中任一項所述之改善劑。
- 如申請專利範圍第10至13項中任一項所述之改善劑,其為飲食品之形態。
- 一種女性特有之身體及/或精神不快症狀之改善劑,其包含雌馬酚。
- 如申請專利範圍第16項所述之改善劑,其中上述女性特有之身體及/或精神不快症狀為月經前及/或月經中之身體及/或精神不快症狀。
- 如申請專利範圍第16或17項所述之改善劑,其中上述女性特有之身體及/或精神不快症狀為選自由疼痛、負向情緒、集中力、及行為變化所組成之群中之一種以上。
- 如申請專利範圍第16至18項中任一項所述之改善劑,其係用以使雌馬酚之單日攝取量成為0.1~50mg而攝取。
- 一種飲食品,其包含如申請專利範圍第16至19項中任一項所述之改善劑。
- 如申請專利範圍第16至19項中任一項所述之改善劑,其為飲食品之形態。
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EP (1) | EP3427731B1 (zh) |
JP (2) | JP6980644B2 (zh) |
KR (1) | KR102602391B1 (zh) |
CN (2) | CN109069476A (zh) |
ES (1) | ES2896748T3 (zh) |
TW (1) | TWI774660B (zh) |
WO (1) | WO2017154865A1 (zh) |
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EP4021433B1 (en) | 2019-08-26 | 2023-10-04 | Period Pill BV | Treatment of menstrual cycle-induced symptoms |
JP7479833B2 (ja) | 2019-12-18 | 2024-05-09 | 小林製薬株式会社 | エストロゲン様活性剤組成物 |
JP7479832B2 (ja) | 2019-12-18 | 2024-05-09 | 小林製薬株式会社 | 経口組成物 |
US20230190702A1 (en) | 2020-05-21 | 2023-06-22 | Daicel Corporation | A composition for improving qol of a 40-year-old or older postmenopausal woman without menopausal disorder |
KR20230040551A (ko) * | 2021-09-16 | 2023-03-23 | 주식회사 엠바이옴쎄라퓨틱스 | 칡발효물을 유효성분으로 포함하는 월경전증후군의 개선, 예방 또는 치료용 조성물 |
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ATE275959T1 (de) * | 1992-05-19 | 2004-10-15 | Graham Edmund Kelly | Verwendung von isoflavon phyto-östrogen extrakten von soja oder klee |
AU6635994A (en) * | 1993-04-16 | 1994-11-08 | Tufts University School Of Medicine | Method for treatment of menopausal and premenstrual symptoms |
JP2003300879A (ja) | 2002-04-09 | 2003-10-21 | Nichimo Co Ltd | Pmsの予防および治療製剤 |
US20040048919A1 (en) * | 2002-07-02 | 2004-03-11 | Dreon Darlene M. | Compositions and methods for reduction of inflammatory symptoms and/or biomarkers in female subjects |
US20050080109A1 (en) * | 2003-10-09 | 2005-04-14 | Papas Andreas M. | Gamma-tocopherol and gamma-tocotrienol therapy for multiple sclerosis |
CN102845685A (zh) * | 2005-12-06 | 2013-01-02 | 大塚制药株式会社 | 含雌马酚的大豆发酵物 |
US20100280231A1 (en) * | 2007-04-09 | 2010-11-04 | Masayuki Nakano | Whitening agent comprising equol or its saccharide derivative as an effective ingredient |
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- 2017-03-07 WO PCT/JP2017/008892 patent/WO2017154865A1/ja active Application Filing
- 2017-03-07 EP EP17763205.6A patent/EP3427731B1/en active Active
- 2017-03-07 CN CN201780024029.5A patent/CN109069476A/zh active Pending
- 2017-03-07 CN CN202311571968.5A patent/CN117643585A/zh active Pending
- 2017-03-07 JP JP2018504490A patent/JP6980644B2/ja active Active
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JP6980644B2 (ja) | 2021-12-15 |
CN117643585A (zh) | 2024-03-05 |
EP3427731A1 (en) | 2019-01-16 |
TWI774660B (zh) | 2022-08-21 |
EP3427731A4 (en) | 2019-10-09 |
US20190099399A1 (en) | 2019-04-04 |
JPWO2017154865A1 (ja) | 2019-01-10 |
KR20180118177A (ko) | 2018-10-30 |
WO2017154865A1 (ja) | 2017-09-14 |
KR102602391B1 (ko) | 2023-11-16 |
CN109069476A (zh) | 2018-12-21 |
EP3427731B1 (en) | 2021-09-29 |
JP2022010363A (ja) | 2022-01-14 |
US20210361615A1 (en) | 2021-11-25 |
ES2896748T3 (es) | 2022-02-25 |
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