TW201818947A - 認知功能低下抑制劑 - Google Patents
認知功能低下抑制劑 Download PDFInfo
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- TW201818947A TW201818947A TW106136656A TW106136656A TW201818947A TW 201818947 A TW201818947 A TW 201818947A TW 106136656 A TW106136656 A TW 106136656A TW 106136656 A TW106136656 A TW 106136656A TW 201818947 A TW201818947 A TW 201818947A
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Abstract
本發明提供一種認知功能低下抑制劑、學習能力提高劑。 本發明之認知功能低下抑制劑或學習能力提高劑將脂質含量未達2質量%或磷脂醯膽鹼含量未達1質量%之肝臟水解物作為有效成分。
Description
本發明係關於一種認知功能低下抑制劑及學習能力提高劑。
癡呆症有血管性癡呆症、阿茲海默氏癡呆症、路易體癡呆症、伴有癡呆症之帕金森氏症、額顳葉癡呆症(fronto-temporal dementia)等。作為癡呆症之核心症狀,有記憶障礙與定向障礙、認知功能障礙,作為周邊症狀,有幻覺/妄想、徘徊、異常之進食行為、睡眠障礙、抑鬱、不安/焦燥、髒話/暴力、性之羞恥心之低下等。 作為癡呆症之治療藥,使用乙醯膽鹼酯酶抑制藥(多奈哌齊、加蘭他敏、利凡斯的明)、NMDA(N-methyl-D-aspartic acid,N-甲基-D-天冬胺酸)受體拮抗劑(美金剛(Memantine))作為認知功能改善藥。然而,該等藥劑存在噁心或嘔吐、食慾不振、腹瀉、腹痛等消化系統症狀之副作用之產生頻度較高之副作用(非專利文獻1)。 [先前技術文獻] [非專利文獻] [非專利文獻1]Medical supply Interview Form(Aricept) [非專利文獻2]日本藥學會第136年會(橫濱)主旨集 28R-pm19及LS24
[發明所欲解決之問題] 本發明之課題在於提供一種副作用較少之認知功能改善劑。 [解決問題之技術手段] 因此,本發明者針對安全性較高之成分,對有無關於認知功能之作用進行了研究,結果報告有:將富含磷脂醯膽鹼之豬肝臟分解物投予至患者,結果有改善認知功能之可能性(非專利文獻2)。其不僅確認了肝臟分解物本身之效果,亦對該特殊之肝臟分解物所富含之磷脂醯膽鹼之作用進行了研究。另一方面,本發明者使用作為認知功能低下模型小鼠之摘除了嗅球小鼠對各種源自天然之成分之作用進行了研究,結果完全意外地發現磷脂醯膽鹼等脂質含量較少之肝臟水解物具有優異之認知功能低下抑制效果及學習能力提高效果,從而完成了本發明。 即,本發明提供以下之[1]~[28]。 [1]一種認知功能低下抑制劑,其將磷脂醯膽鹼含量未達1質量%之肝臟水解物作為有效成分。 [2]一種學習能力提高劑,其將磷脂醯膽鹼含量未達1質量%之肝臟水解物作為有效成分。 [3]一種認知功能低下抑制用食品組合物,其將磷脂醯膽鹼含量未達1質量%之肝臟水解物作為有效成分。 [4]一種學習能力提高用食品組合物,其將磷脂醯膽鹼含量未達1質量%之肝臟水解物作為有效成分。 [5]一種認知功能低下抑制劑,其將脂質含量未達2質量%之肝臟水解物作為有效成分。 [6]一種學習能力提高劑,其將脂質含量未達2質量%之肝臟水解物作為有效成分。 [7]一種認知功能低下抑制用食品組合物,其將脂質含量未達2質量%之肝臟水解物作為有效成分。 [8]一種學習能力提高用食品組合物,其將脂質含量未達2質量%之肝臟水解物作為有效成分。 [9]一種磷脂醯膽鹼含量未達1質量%之肝臟水解物之用途,其係用於製造認知功能低下抑制劑。 [10]一種磷脂醯膽鹼含量未達1質量%之肝臟水解物之用途,其係用於製造學習能力提高劑。 [11]一種磷脂醯膽鹼含量未達1質量%之肝臟水解物之用途,其係用於製造認知功能低下抑制用食品組合物。 [12]一種磷脂醯膽鹼含量未達1質量%之肝臟水解物之用途,其係用於製造學習能力提高用食品組合物。 [13]一種脂質含量未達2質量%之肝臟水解物之用途,其係用於製造認知功能低下抑制劑。 [14]一種脂質含量未達2質量%之肝臟水解物之用途,其係用於製造學習能力提高劑。 [15]一種脂質含量未達2質量%之肝臟水解物之用途,其係用於製造認知功能低下抑制用食品組合物。 [16]一種脂質含量未達2質量%之肝臟水解物之用途,其係用於製造學習能力提高用食品組合物。 [17]一種磷脂醯膽鹼含量未達1質量%之肝臟水解物,其用於抑制認知功能低下。 [18]一種磷脂醯膽鹼含量未達1質量%之肝臟水解物,其用於提高學習能力。 [19]一種磷脂醯膽鹼含量未達1質量%之肝臟水解物之使用方法,其用於非治療性認知功能低下抑制。 [20]一種磷脂醯膽鹼含量未達1質量%之肝臟水解物之使用方法,其用於非治療性學習能力提高。 [21]一種脂質含量未達2質量%之肝臟水解物,其用於抑制認知功能低下。 [22]一種脂質含量未達2質量%之肝臟水解物,其用於提高學習能力。 [23]一種脂質含量未達2質量%之肝臟水解物之使用方法,其用於非治療性認知功能低下抑制。 [24]一種脂質含量未達2質量%之肝臟水解物之使用方法,其用於非治療性學習能力提高。 [25]一種認知功能低下抑制方法,其特徵在於攝取磷脂醯膽鹼含量未達1質量%之肝臟水解物之有效量。 [26]一種學習能力提高方法,其特徵在於攝取磷脂醯膽鹼含量未達1質量%之肝臟水解物之有效量。 [27]一種認知功能低下抑制方法,其特徵在於攝取脂質含量未達2質量%之肝臟水解物之有效量。 [28]一種學習能力提高方法,其特徵在於攝取脂質含量未達2質量%之肝臟水解物之有效量。 [發明之效果] 根據本發明,藉由攝取即便大量攝取亦不會有副作用之肝臟水解物,可抑制作為癡呆症之症狀之認知功能低下,又,可提高學習能力。
本發明之認知功能低下抑制劑及學習能力提高劑之有效成分係磷脂醯膽鹼含量未達1質量%或脂質含量未達2質量%之肝臟水解物。磷脂醯膽鹼含量可藉由測定包含磷脂醯膽鹼之磷脂質之量而特定。磷脂醯膽鹼含量未達1質量%,然更佳為0.5質量%以下,進而較佳為0.25質量%以下。又,脂質含量未達2質量%,更佳為1質量%以下,進而較佳為0.5質量%以下。 肝臟水解物亦被稱為肝臟加水分解物、肝臟萃取物、肝臟分解萃取物、肝水解物,係藉由消化酶等將肝臟水解而獲得者,用作肝功能之改善藥。作為原料之肝臟,使用牛、豬、鰹魚、鯨魚等之新鮮之肝臟。所獲得之水解物較佳為濃縮後使用。較佳為列舉上述定為醫藥品之肝臟水解物。 肝臟水解物中,以低分子肽作為主成分並且包含各種胺基酸、核苷酸、維生素、礦物質等。更詳細而言,較佳為包含胺基酸19~78質量%、肽及蛋白質17~73質量%、糖類1.8~11質量%、脂質0.005~0.04質量%、核酸0.7~2.5質量%、無機物1.6~5.4質量%、維生素0.03~0.2質量%、麩胱甘肽0.8質量%以下。又,更佳為包含胺基酸23~65質量%、肽及蛋白質20~61質量%、糖類2.2~8.6質量%、脂質0.006~0.035質量%、核酸0.9~2.1質量%、無機物1.9~4.5質量%、維生素0.04~0.15質量%、麩胱甘肽0.7質量%以下,進而較佳為包含胺基酸29~52質量%、肽及蛋白質25~49質量%、糖類2.8~6.9質量%、脂質0.008~0.03質量%、核酸1.1~1.7質量%、無機物2.4~3.6質量%、維生素0.05~0.12質量%、麩胱甘肽0.6質量%以下。 該等成分之中,作為胺基酸組成,較佳為Ala 17~68 mg/g、Arg 0.6~4.4 mg/g、Asp 9~48 mg/g、胱胺酸5 mg/g以下、Glu 18~63 mg/g、Gly 10~39 mg/g、His 3~17 mg/g、Ile 14~56 mg/g、Leu 26~98 mg/g、Lys 15~65 mg/g、Met 0.3~20 mg/g、Phe 13~46 mg/g、Pro 10~48 mg/g、Ser 12~49 mg/g、Thr 12~45 mg/g、Trp 3~13 mg/g、Tyr 1.6~41 mg/g、Val 18~71 mg/g。又,更佳為Ala 21~57 mg/g、Arg 0.8~3.6 mg/g、Asp 11~40 mg/g、胱胺酸4 mg/g以下、Glu 22~53 mg/g、Gly 13~32 mg/g、His 4~14 mg/g、Ile 17~47 mg/g、Leu 32~82 mg/g、Lys 18~54 mg/g、Met 0.4~17 mg/g、Phe 15~38 mg/g、Pro 12~40 mg/g、Ser 15~41 mg/g、Thr 14~38 mg/g、Trp 3.8~11 mg/g、Tyr 1.9~34 mg/g、Val 21~59 mg/g,進而較佳為Ala 26~45 mg/g、Arg 1~2.9 mg/g、Asp 14~32 mg/g、胱胺酸3 mg/g以下、Glu 27~42 mg/g、Gly 16~26 mg/g、His 5~11 mg/g、Ile 21~40 mg/g、Leu 40~66 mg/g、Lys 22~43 mg/g、Met 0.5~14 mg/g、Phe 19~31 mg/g、Pro 15~32 mg/g、Ser 18~33 mg/g、Thr 18~30 mg/g、Trp 4.8~8.4 mg/g、Tyr 2.4~27 mg/g、Val 27~48 mg/g。 上述肝臟水解物如下述實施例所示,於作為癡呆症模型小鼠之摘除了嗅球之小鼠中顯示出認知功能低下抑制作用。又,對於正常小鼠亦顯示出學習能力提高效果。因此,磷脂醯膽鹼含量未達1質量%或脂質含量未達2質量%之肝臟水解物作為認知功能低下抑制劑、學習能力提高劑有用。 認知功能障礙可列舉記憶障礙與定向障礙(無法辨識時間、場所、人物)、計算能力之低下、判斷力低下、失語、失認、失用、執行功能障礙。學習能力包括記憶、定向、計算能力、判斷力等。 本發明之認知功能低下抑制劑及/或學習能力提高劑可藉由經口投予、經皮投予、經腸投予、經靜脈投予等進行投予,更佳為經口投予。作為經口投予用之製劑,可列舉液劑、錠劑、散劑、細粒劑、顆粒劑、膠囊劑等,較佳為液劑、錠劑,更佳為液劑。 為了製成該等經口投予製劑,可使用乳糖、甘露糖醇、玉米澱粉、結晶纖維素等賦形劑、纖維素衍生物、***膠、明膠等結合劑、羧甲基纖維素鈣等崩解劑、滑石、硬脂酸鎂等潤滑劑、非離子界面活性劑等增溶劑、矯味劑、甜味劑、穩定劑、pH值調整劑、水、乙醇、丙二醇、甘油等。又,亦可使用羥甲基纖維素鄰苯二甲酸酯、乙酸羥丙基甲基纖維素琥珀酸酯、乙酸纖維素鄰苯二甲酸酯、甲基丙烯酸酯共聚物等被覆劑。 又,亦可於本發明之認知功能低下抑制劑及/或學習能力提高劑中調配其他有效成分。作為其他有效成分,可列舉:維生素B1
類:硫胺素、硝酸硫胺素、鹽酸硫胺素、呋喃硫胺、雙苯醯硫胺、苯磷硫胺、二硫硫胺、地塞硫胺、丙硫硫胺及該等之衍生物;維生素B2
類:核黃素及衍生物以及該等之鹽;維生素B3
類:菸酸(niacin)、菸鹼酸(nicotinic acid)、菸鹼醯胺及衍生物以及該等之鹽;維生素B5
類:泛醇、泛酸及衍生物以及該等之鹽;維生素B6
類:吡哆醇及衍生物以及該等之鹽;維生素B12
類:氰鈷胺及衍生物以及該等之鹽;其他維生素類:維生素A、維生素C、維生素E、維生素K、維生素P、二氯乙酸二異丙胺、牛磺酸、硫酸軟骨素、蜂王漿、咖啡因、薑黃、水飛薊、蒲公英、西洋蒲公英、牛蒡、大蒜、菊花、洋蓍草、梔子、芝麻、田七、蘆筍、洋蔥、菊苣、藥用鼠尾草、朝鮮薊(artichoke)、枸杞、豆科/菖蒲科之植物、斑葉蘭、Struthanthus Flexicaulis Mart.、香膏萼距花(Cuphea balsamona Cham.)、野梧桐、紅茶、白藜蘆醇、兒茶素類、小檗鹼、迷迭香、豆萃取物、二甲雙胍、蛋黃卵磷脂、DHA(docosahexaenoic acid,二十二碳六烯酸)、EPA(eicosapentaenoic acid,二十碳五烯酸)、ARA(arachidonic acid,二十碳四烯酸)、維生素D、銀杏、阿魏酸、氫、縮醛磷脂(plasmalogen)、園當歸(garden angelica)、假馬齒莧(Bacopa monniera)等。 又,本發明之認知功能低下抑制劑及/或學習能力提高劑除可用作醫藥品之外,亦可用作準藥品、特定保健用食品、面向兒童之食品、運動飲料、康復用飲料、寵物食品等功能性食品等食品組合物。 本發明之認知功能低下抑制劑及/或學習能力提高劑中之肝臟水解物之含量根據投予形態而有所不同,通常以乾燥重量計較佳為0.001~10質量%,更佳為0.001~5質量%。又,本發明之認知功能低下抑制劑及/或學習能力提高劑中之肝臟水解物之成人1天投予量以乾燥重量計較佳為3 g~10 g,更佳為3.5 g~8 g,進而較佳為4 g~7.5 g。 [實施例] 繼而,列舉實施例對本發明詳細地進行說明,但本發明並不受其任何限定。 參考例1 肝臟水解物之膽鹼量之測定係依據以下之磷脂質量之定量法進行。 磷脂質係使用磷脂質C-Test Wako(和光純藥工業股份有限公司,體外診斷用醫藥品)而定量(Takayama等人,1977)。即,利用水將磷脂質C-Test Wako之測定套組中所包含之基準液氯化膽鹼54 mg/100 mL(相當於磷脂質300 mg/100 mL)稀釋而進行調整,製成標準溶液。精確稱量試樣約0.1 g,添加水使之溶解,準確製成10 mL而製成試樣溶液。但是,於試樣不溶解於水之情形時,添加水5 mL,並使用超音波使之均勻地分散後,添加水而準確製成10 mL。使用孔徑0.45 μm以下之薄膜過濾器對該液體進行過濾。將最開始之2 mL濾液去除,並將之後之濾液作為試樣溶液。量取標準溶液及試樣溶液各20 μL,於各者中準確添加顯色試液3 mL並充分地振盪混合後,以37℃加熱5分鐘。針對該等液體,將使用水20 μL同樣地進行操作而獲得之液體作為對照,藉由紫外可見吸光度測定法進行試驗。測定由標準溶液及試樣溶液獲得之各個液體於波長600 nm下之吸光度AS
及AT
。根據各個標準溶液所對應之吸光度製作校準曲線,並根據其回歸方程式求出吸光度AT
所對應之氯化膽鹼之量。 實施例1 (1)實驗動物 實驗使用28~30 g之ddY系雄性小鼠(日本SLC),於供於實驗之前於室溫22±2℃、濕度55±5%、明暗循環12小時(明期7:00~19:00,暗期19:00~7:00)之固定環境下進行飼養。動物於塑膠籠(長30 cm×寬20 cm×高15 cm)中以5~7匹之比率進行飼養。 (2)嗅球摘除法 藉由投予戊巴比妥(Somnopentyl)(50 mg/kg、i.p.)而進行全身麻醉後,將小鼠固定於腦定位裝置,於嗅球(olfactory bulb:OB)之正上方之頭蓋骨利用齒科用鑽頭開2個孔,藉由抽吸(新空氣工製造,C-12型抽吸泵)將包含嗅前核(anterior olfactory nucleus)之嗅球之2/3以上摘除。其後,為了進行止血,將spongel(Astellas Pharma)填入摘除部位,用於實驗。為了對OBX(olfactory bulbectomy,嗅球摘除)手術所產生之影響進行研究,將未進行藉由抽吸之OBX,而僅以不產生損傷之方式於頭蓋骨開孔,並利用spongel將孔堵住之小鼠作為偽手術(Sham)組用於實驗。再者,針對進行了OBX處理之小鼠,於實驗結束後進行開顱,將腦取出並對手術部位進行確認,將前額葉皮質存在損傷者或嗅球殘留者自資料中排除。 (3)使用藥物及調整方法 使用藥物係使用肝臟水解物(ZERIA Pharmaceutical股份有限公司,磷脂醯膽鹼檢測極限以下)及作為溶劑之自來水。肝臟水解物係利用自來水以成為1%之方式溶解。藥物投予係自OBX手術前之1週前起利用給水瓶自由地攝取合計5週。 (4)評價方法 小鼠以背朝閘門之形式放入至被動回避學習裝置之明室中後,通過閘門而向暗室移動。確認完全移動至暗室中且四肢登上金屬之柵極後施加電刺激(1 mA,500 sec),將其設為學習階段(Learning trial),其後將小鼠放回籠中。學習階段結束後立即將嗅球摘除。於手術後第28天,與學習階段時同樣地將OBX小鼠放入明室中,測定進入暗室前之時間即反應潛伏時間(Latency time),將其設為試驗階段(Test trial)。學習階段、試驗階段均將截止時間(cut-off time)設定為10分鐘(圖1)。 (5)統計處理 實驗結果以平均值與標準誤差表示。有意義差檢定係於分散分析後,利用費雪PLSD(protected least significant differences,保護最小顯著性差異)事後比較檢驗(post-hoc test)將危險率5%以下判定為存在有意義差。再者,該等檢定係使用Stat view-J 5.0。 (6)結果 將結果示於圖2。 手術後第28天(4週)之投予有溶劑之OBX組之Latency time(反應潛伏時間)與投予有溶劑之偽手術組相比有意義地減少(**p<0.01)。 投予有1%肝臟水解物之OBX組與投予有溶劑之OBX組相比,顯示出反應潛伏時間之有意義之延長(#p<0.05)。 於投予有1%肝臟水解物之偽手術組中,與投予有溶劑之偽手術組相比,亦顯示出反應潛伏時間之有意義之延長(*p<0.05)。
圖1表示實施例1之試驗操作流程。 圖2表示實施例1之試驗結果。
Claims (16)
- 一種認知功能低下抑制劑,其將磷脂醯膽鹼含量未達1質量%之肝臟水解物作為有效成分。
- 一種學習能力提高劑,其將磷脂醯膽鹼含量未達1質量%之肝臟水解物作為有效成分。
- 一種認知功能低下抑制用食品組合物,其將磷脂醯膽鹼含量未達1質量%之肝臟水解物作為有效成分。
- 一種學習能力提高用食品組合物,其將磷脂醯膽鹼含量未達1質量%之肝臟水解物作為有效成分。
- 一種認知功能低下抑制劑,其將脂質含量未達2質量%之肝臟水解物作為有效成分。
- 一種學習能力提高劑,其將脂質含量未達2質量%之肝臟水解物作為有效成分。
- 一種認知功能低下抑制用食品組合物,其將脂質含量未達2質量%之肝臟水解物作為有效成分。
- 一種學習能力提高用食品組合物,其將脂質含量未達2質量%之肝臟水解物作為有效成分。
- 一種磷脂醯膽鹼含量未達1質量%之肝臟水解物之用途,其係用於製造認知功能低下抑制劑。
- 一種磷脂醯膽鹼含量未達1質量%之肝臟水解物之用途,其係用於製造學習能力提高劑。
- 一種磷脂醯膽鹼含量未達1質量%之肝臟水解物之用途,其係用於製造認知功能低下抑制用食品組合物。
- 一種磷脂醯膽鹼含量未達1質量%之肝臟水解物之用途,其係用於製造學習能力提高用食品組合物。
- 一種脂質含量未達2質量%之肝臟水解物之用途,其係用於製造認知功能低下抑制劑。
- 一種脂質含量未達2質量%之肝臟水解物之用途,其係用於製造學習能力提高劑。
- 一種脂質含量未達2質量%之肝臟水解物之用途,其係用於製造認知功能低下抑制用食品組合物。
- 一種脂質含量未達2質量%之肝臟水解物之用途,其係用於製造學習能力提高用食品組合物。
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