TWI679014B - 肝臟水解物用以製造胰臟機能改善劑之用途 - Google Patents
肝臟水解物用以製造胰臟機能改善劑之用途 Download PDFInfo
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- TWI679014B TWI679014B TW103133074A TW103133074A TWI679014B TW I679014 B TWI679014 B TW I679014B TW 103133074 A TW103133074 A TW 103133074A TW 103133074 A TW103133074 A TW 103133074A TW I679014 B TWI679014 B TW I679014B
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- liver
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- hydrolysate
- alcohol
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Abstract
本發明提供一種改善由通常之生活習慣所造成之胰臟機能及/或肝臟機能的藥劑。
本發明係一種以肝臟水解物作為有效成分的攝取高脂肪食物及酒精之情況下之肝臟機能改善劑及/或胰臟機能改善劑。
Description
本發明係關於一種肝臟機能改善劑及/或胰臟機能改善劑。
胰臟會生成分泌出多種消化酶,並且分泌出控制血糖值之胰島素及升糖素。其中,胰島素係使血糖值降低之激素,若胰島素之分泌下降,則導致糖尿病。
作為促進胰島素分泌之藥劑,已知有磺醯脲藥、DPPIV(dipeptidyl peptidase IV,二肽基肽酶IV)抑制藥、GLP-1(Glucagon-like peptide-1,類升糖素肽-1)類似物等,但報告有低血糖、體重增加等副作用。
又,肝臟除了具有營養素之代謝及儲存以外,亦具有生成膽汁、解毒、排泄等機能。作為肝臟疾病,有病毒性肝炎、酒精性肝炎、藥劑性肝炎、NASH(non-alcoholic steatohepatitis,非酒精性脂肪性肝炎)、肝癌、慢性肝炎、肝硬化等,具有若肝臟之機能下降則難以復健之特徵。
作為肝臟疾病治療劑,已知有干擾素或麩胱甘肽、甘草素(glycyrrhizin)製劑等肝保護劑。又,現狀為多數肝臟疾病治療藥之篩選係採用四氯化碳肝損傷模型等藥物肝炎模型。
且說,已知肝臟水解物具有慢性肝疾病之肝機能之改善作用(非專利文獻1)。認為該作用係基於由上述四氯化碳肝損傷模型所產生之效果者(專利文獻1)。
[專利文獻1]日本專利特開2002-80388號公報
[非專利文獻1]Gosper Lever腸溶錠說明書
然而,先前之肝疾病治療藥之篩選方法為藥物肝損傷模型,並非反映出實際之肝臟機能下降之狀態者。又,肝臟機能下降之狀態多為因包括通常之飲食在內之生活習慣所產生者,尚不存在改善此種狀態之醫藥。又,胰臟之機能下降、即血糖值之上升亦多為因生活習慣所產生者,亦謀求改善此種狀態之安全藥劑。
因此,本發明之課題在於提供一種改善由通常之生活習慣所造成生之胰臟機能及/或肝臟機能的藥劑。
因此,本發明者為了找出改善因飲食習慣所產生之肝臟及胰臟之機能下降而非因四氯化碳之類的藥物所產生之肝臟或胰臟之機能下降的藥物,進行了各種研究,結果藉由使大鼠攝取高脂肪食物及酒精而成功地製作出肝臟機能及胰臟機能於短期間下降之模型,藉由使用該模型,發現肝臟水解物作為攝取高脂肪食物及酒精之情況下之肝臟機能及/或胰臟機能之改善劑有用,從而完成本發明。
即,本發明提供以下之[1]~[20]。
[1]一種肝臟機能改善劑,其係以肝臟水解物作為有效成分的攝取高脂肪食物及酒精之情況下之肝臟機能改善劑。
[2]一種胰臟機能改善劑,其以肝臟水解物作為有效成分。
[3]如[2]之胰臟機能改善劑,其係攝取高脂肪食物及酒精之情況
下之胰臟機能改善劑。
[4]如[2]或[3]之胰臟機能改善劑,其係胰島素分泌障礙改善劑。
[5]一種攝取高脂肪食物及酒精之情況下之肝臟機能及胰臟機能改善劑,其以肝臟水解物作為有效成分。
[6]一種肝臟水解物,其用於改善攝取高脂肪食物及酒精之情況下之肝臟機能。
[7]一種肝臟水解物,其用於改善胰臟機能。
[8]如[7]之肝臟水解物,其係用於改善攝取高脂肪食物及酒精之情況下之胰臟機能者。
[9]如[7]或[8]之肝臟水解物,其係用於改善胰島素分泌障礙者。
[10]一種肝臟水解物,其用於改善攝取高脂肪食物及酒精之情況下之肝臟機能及胰臟機能。
[11]一種肝臟水解物之用途,其用於製造攝取高脂肪食物及酒精之情況下之肝臟機能改善劑。
[12]一種肝臟水解物之用途,其用於製造胰臟機能改善劑。
[13]如[12]之用途,其用於製造攝取高脂肪食物及酒精之情況下之胰臟機能改善劑。
[14]如[12]或[13]之用途,其用於製造胰島素分泌障礙改善劑。
[15]一種肝臟水解物之用途,其用於製造攝取高脂肪食物及酒精之情況下之肝臟機能及胰臟機能改善劑。
[16]一種攝取高脂肪食物及酒精之情況下之肝臟機能之改善方法,其特徵在於投予肝臟水解物。
[17]一種胰臟機能之改善方法,其特徵在於投予肝臟水解物。
[18]如[17]之方法,其係攝取高脂肪食物及酒精之情況下之胰臟機能之改善方法。
[19]如[17]或[18]之方法,其係胰島素分泌障礙之改善方法。
[20]一種攝取高脂肪食物及酒精之情況下之肝臟機能及胰臟機能之改善方法,其特徵在於投予肝臟水解物。
本發明之肝臟機能及/或胰臟機能改善劑可改善因通常之飲食生活的攝取高脂肪食物及酒精所造成之肝臟機能及/或胰臟機能,並且安全性亦較高而可供長期攝取。又,關於肝臟水解物對因攝取高脂肪食物及酒精所產生之肝臟機能及/或胰臟機能之改善作用,以較先前之四氯化碳肝損傷模型之投予量更低之用量即屬有效,其作用明顯不同。
圖1係表示肝臟水解物對攝取高脂肪食物及酒精之情況下之AST(Aspartate Aminotransferase,天冬胺酸轉胺酶)活性及ALT(Alanine Amiotransferase,丙胺酸轉胺酶)活性之上升抑制效果的圖。
圖2係表示肝臟水解物對攝取高脂肪食物及酒精之情況下之胰島素分泌障礙改善效果的圖。
本發明之肝臟機能及/或胰臟機能改善劑之有效成分為肝臟水解物。肝臟水解物亦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,係利用消化酶等將肝臟水解而獲得者,且係用作為肝機能之改善藥者。關於作為原料之肝臟,可使用牛、豬、鰹魚、鯨魚等非人動物之新鮮肝臟。所獲得之水解物較佳為濃縮使用。較佳可列舉的是上述被定為醫藥品之肝臟水解物。
肝臟水解物係以低分子肽作為主成分且包含各種胺基酸、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%以下者。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%以下者,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%以下者。
該等成分之中,作為胺基酸組成,較佳為Ala 17~68mg/g、Arg 0.6~4.4mg/g、Asp 9~48mg/g、胱胺酸5mg/g以下、Glu 18~63mg/g、Gly 10~39mg/g、His 3~17mg/g、Ile 14~56mg/g、Leu 26~98mg/g、Lys 15~65mg/g、Met 0.3~20mg/g、Phe 13~46mg/g、Pro 10~48mg/g、Ser 12~49mg/g、Thr 12~45mg/g、Trp 3~13mg/g、Tyr 1.6~41mg/g、Val 18~71mg/g。又,更佳為Ala 21~57mg/g、Arg 0.8~3.6mg/g、Asp 11~40mg/g、胱胺酸4mg/g以下、Glu 22~53mg/g、Gly 13~32mg/g、His 4~14mg/g、Ile 17~47mg/g、Leu 32~82mg/g、Lys 18~54mg/g、Met 0.4~17mg/g、Phe 15~38mg/g、Pro 12~40mg/g、Ser 15~41mg/g、Thr 14~38mg/g、Trp 3.8~11mg/g、Tyr 1.9~34mg/g、Val 21~59mg/g,進而較佳為Ala 26~45mg/g、Arg 1~2.9mg/g、Asp 14~32mg/g、胱胺酸3mg/g以下、Glu 27~42mg/g、Gly 16~26mg/g、His 5~11mg/g、Ile 21~40mg/g、Leu 40~66mg/g、Lys 22~43mg/g、Met 0.5~14mg/g、Phe 19~31mg/g、Pro 15~32mg/g、Ser 18~33mg/g、Thr 18~30mg/g、Trp 4.8~8.4mg/g、Tyr 2.4~27mg/g、Val 27~48mg/g。
對於肝臟水解物,已知改善慢性肝疾病中之肝機能或四氯化碳
肝損傷,但並不知曉其會改善攝取高脂肪食物及酒精之情況下之肝臟機能或胰臟機能。
如下述實施例所示,肝臟水解物具有改善因攝取高脂肪食物與酒精之通常飲食習慣所產生之肝臟機能及胰臟機能的作用。該肝臟水解物之效果例如與專利文獻1之針對四氯化碳肝損傷之效果相比,會於更低用量下產生。即,對於專利文獻1之四氯化碳肝損傷,於飲食中添加2%時有效,相對於此,對於攝取高脂肪食物及酒精之情況下之肝損傷,於飲食中添加低濃度之0.031%時有效。因此,認為肝臟水解物對攝取高脂肪食物及酒精之情況下之肝臟機能改善效果係作用機理不同於對四氯化碳肝損傷模型之效果者。
作為本發明之肝臟機能,可列舉AST活性及ALT活性之上升抑制作用。又,作為本發明之胰臟機能,可列舉胰島素分泌障礙改善作用。
本發明之肝臟機能及/或胰臟機能改善劑可藉由經口投予、經皮投予、經腸投予、經靜脈投予等而投予,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、甘露醇、玉米澱粉、結晶纖維素等賦形劑;纖維素衍生物、阿拉伯膠、明膠等結合劑;羧基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溶解助劑、矯味劑、甜味劑、穩定劑、pH值調整劑、水、乙醇、丙二醇、甘油等。又,羥甲基纖維素鄰苯二甲酸酯、乙酸羥基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,本發明之肝臟機能及/或胰臟機能改善劑中亦可調配其他有效成分。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、硫胺素二硫化物、基硫胺、硫胺素丙基二硫化物及該等之衍生物、維生素B2類;核黃素及衍生物以及該等之鹽、維生素B3類;菸鹼、菸鹼酸、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、西洋鋸葉草、梔子、芝麻、田七人參、蘆筍、洋蔥、菊苣、藥用鼠尾草、朝鮮薊(artichoke)、枸杞、豆科‧鳶尾科之植物、斑葉蘭、Struthantus Flexicaulis Mart.、Cuphea balsamona Cham.、Mallotus Japonicus Mueller Agroviensis、紅茶、白藜蘆醇、兒茶素類、小檗鹼、迷迭香、豆萃取物、二甲雙胍等。
又,本發明之肝臟機能及/或胰臟機能改善劑除了醫藥品以外,亦可用作為準藥品、特定保健用食品、運動飲料、復健用飲料、寵物食品等機能性食品。
本發明之肝臟機能及/或胰臟機能改善劑中之肝臟水解物之含量亦根據投予形態而異,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,本發明之肝臟機能及/或胰臟機能改善劑中之肝臟水解物之1日投予量以乾燥重量計較佳為100mg~1076mg,更佳為383mg~623mg,進而較佳為351mg~680mg。
其次,列舉實施例而詳細地說明本發明,但本發明不受該等任何限定。
(實驗方法)
使用7週齡之Wistar/Std系之雌大鼠24隻(日本SLC(股份))。於晝夜各12小時之明暗週期(明期:08:00-20:00)之動物室(溫度23±2℃,濕度50±10%RH)內個別飼養。於實驗開始前,以固形飼料適應飼養3天(船橋農場F-2),其後分為兩個實驗群。即,製備含有分離大豆蛋白質(Soy proteinisolate=SPI)者、與含有豬肝臟水解物(PLH)者作為對照,添加至酒精流質食物中並提供14天。
於處死14小時前,撤去酒精流質食物而禁食,代而提供去離子水。進行採血並置於經EDTA-2Na處理之採血管中,進行離心分離而取得血漿,將各種分析用組織樣品保存於-25℃。肝臟係於摘取一部分後利用液氮急速地進行冷凍,保存於-70℃而作為其後之分析用試樣。
液體飼料之製作係基於1989年加以改善之Lieber-DeCarli配方而製作(表1)。攪拌係使用Braun公司製造之混合機。再者,關於報告有因添加而促進酒精性肝損傷之維生素A,製備含有通常之維生素混合之5倍量者而供於飼料。
‧對照群食物(Con)
‧對照群酒精食物(Con-Alc)
‧豬肝臟水解物酒精食物(PLH-Alc)
將所使用之肝臟水解物中所含之成分及胺基酸組成示於表3。
使用7週齡之雌性Wistar系大鼠(Wistar/Std),於以下之條件下進行14天之實驗飼養。實驗群設為酒精群及對照群之兩群,進行配對飼養(pair feeding)。於飼養期間,自尾靜脈採取血漿,測定作為肝損傷標記物之血漿GPT(麩胺酸丙酮酸轉胺酶[=ALT「丙胺酸轉胺酶」])活性、GOT(麩胺酸草醯乙酸轉胺酶[=AST「天冬胺酸轉胺酶」])活性
及血漿胰島素。關於乙醇投予條件,基於進行對酒精之適應之必要性,而自3%濃度飼料開始,於第4天以後提昇為含有5%之食物。將測定項目匯總於以下。
‧血漿中肝損傷標記物之測定(ALT、AST):和光純藥上業(股份)之Transaminase CII套組進行測定。
‧胰島素之測定:使用森永生科學研究所之胰島素測定套組進行測定。
(結果)
如圖1所示,肝臟水解物預防了攝取高脂肪及酒精之情況下之肝損傷。
又,如圖2所示,肝臟水解物預防了攝取高脂肪及酒精之情況下之胰島素分泌障礙。
Claims (2)
- 一種肝臟水解物之用途,其係用於製造攝取高脂肪食物及酒精之情況下之胰臟機能改善劑。
- 如請求項1之用途,其係用於製造胰島素分泌障礙改善劑。
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JP2002080388A (ja) * | 2000-09-04 | 2002-03-19 | Takeda Food Products Ltd | 肝機能賦活剤 |
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