CN101247801B - 血中酒精浓度上升抑制用组合物 - Google Patents
血中酒精浓度上升抑制用组合物 Download PDFInfo
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- CN101247801B CN101247801B CN2006800308919A CN200680030891A CN101247801B CN 101247801 B CN101247801 B CN 101247801B CN 2006800308919 A CN2006800308919 A CN 2006800308919A CN 200680030891 A CN200680030891 A CN 200680030891A CN 101247801 B CN101247801 B CN 101247801B
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Abstract
期望能够通过抑制饮酒后血中酒精浓度上升而防止酩酊大醉状态,产生享受适度醉酒的快乐饮酒状态的医药品、功能性食品等。即,本发明的目的是提供血中酒精浓度上升抑制用组合物。根据本发明,可以提供一种血中酒精浓度上升抑制用组合物,其含有鸟氨酸、精氨酸、赖氨酸、组氨酸、瓜氨酸等碱性氨基酸或其盐作为有效成分。
Description
技术领域
本发明涉及含有碱性氨基酸或其盐作为有效成分的血中酒精浓度上升抑制用组合物。
背景技术
过度饮酒导致的酩酊大醉状态中,伴随饮酒的社交失败、意识障碍造成的事故、事件增加等给社会带来很多负面因素。
以往,作为使饮酒后血中酒精浓度下降或者抑制其上升的物质或组合物,已知有柿子醋(参照专利文献1),甘蓝、红紫苏、人参及欧芹的榨汁混合物(参照专利文献2),高丽参的水性溶剂提取物的乙醇不溶物(参照专利文献3),甘油(参照专利文献4),含有茶提取物和卟啉类色素的组合物(参照专利文献5),黄瓜提取物(参照专利文献6)等。
另一方面,急性酒精中毒模型中,已知通过丙氨酸、苏氨酸、亮氨酸、异亮氨酸等氨基酸的单独给用生存率上升,但是通过精氨酸、赖氨酸、鸟氨酸等氨基酸、α-酮戊二酸、苹果酸、草酰乙酸、丙酮酸等有机酸的单独给用生存率不上升(参照专利文献7)。
专利文献1:日本特开昭63-141562号公报
专利文献2:日本特开平2-138128号公报
专利文献3:日本特开平5-170659号公报
专利文献4:日本特开平6-14751号公报
专利文献5:日本特开平6-256201号公报
专利文献6:日本特开2001-58592号公报
专利文献7:日本特开昭61-50917号公报
发明内容
期望能够通过抑制饮酒后血中酒精浓度上升而防止酩酊大醉状态,产生享受适度醉酒的快乐饮酒状态的医药品、功能性食品等。
即,本发明的目的是提供血中酒精浓度上升抑制用组合物。
本发明涉及以下(1)~(14)。
(1)一种血中酒精浓度上升抑制用组合物,其含有碱性氨基酸或其盐作为有效成分。
(2)上述(1)的组合物,其中,碱性氨基酸为鸟氨酸、精氨酸、赖氨酸、组氨酸或者瓜氨酸。
(3)上述(1)或(2)的组合物,其含有有机酸。
(4)上述(3)的组合物,其中,有机酸为醋酸、乳酸、苹果酸、富马酸、酒石酸或柠檬酸。
(5)上述(1)~(4)任一项的组合物,其中,组合物为医药或者食品添加剂。
(6)一种饮食品,其含有上述(5)的食品添加剂。
(7)一种血中酒精浓度上升抑制方法,包括向需要的对象给用或使其摄取有效量的碱性氨基酸或其盐。
(8)上述(7)的方法,其中,碱性氨基酸为鸟氨酸、精氨酸、赖氨酸、组氨酸或者瓜氨酸。
(9)上述(7)或(8)的方法,包括进一步给用或摄取有机酸。
(10)上述(9)的方法,其中,有机酸为醋酸、乳酸、苹果酸、富马酸、酒石酸或柠檬酸。
(11)碱性氨基酸或其盐用于制造血中酒精浓度上升抑制用组合物的应用。
(12)上述(11)的应用,其中,碱性氨基酸为鸟氨酸、精氨酸、赖氨酸、组氨酸或者瓜氨酸。
(13)上述(11)或(12)的应用,包括进一步使用有机酸。
(14)上述(13)的应用,其中,有机酸为醋酸、乳酸、苹果酸、富马酸、酒石酸或柠檬酸。
发明效果
通过本发明,可以提供含有碱性氨基酸或其盐作为有效成分的安全有效的血中酒精浓度上升抑制用组合物。
附图说明
图1是表示鸟氨酸抑制乙醇摄取后血中乙醇浓度上升的效果的图。图中的■表示对照组,○表示试验组1(摄取鸟氨酸盐酸盐),△表示试验组2(摄取鸟氨酸盐酸盐和柠檬酸)。另外,纵轴表示血中乙醇浓度(g/L),横轴表示乙醇摄取后的经过时间(小时)。*和**各自表示在学生t检验中危险率小于5%及小于1%,且表示对于对照组有显著差异。
图2是表示组氨酸抑制乙醇摄取后血中乙醇浓度上升的效果的图。图中的■表示对照组,○表示试验组1(摄取组氨酸),△表示试验组2(摄取组氨酸盐酸盐)。另外,纵轴表示血中乙醇浓度(g/L),横轴表示乙醇摄取后的经过时间(小时)。*表示在学生t检验中危险率小于5%,且表示对于对照组有显著差异。
图3是表示赖氨酸或瓜氨酸抑制乙醇摄取后血中乙醇浓度上升的效果的图。图中的■表示对照组,△表示试验组1(摄取赖氨酸柠檬酸盐),○表示试验组2(摄取瓜氨酸)。另外,纵轴表示血中乙醇浓度(g/L),横轴表示乙醇摄取后的经过时间(小时)。*表示在学生t检验中危险率小于5%,且表示对于对照组有显著差异。
图4是表示赖氨酸抑制乙醇摄取后血中乙醇浓度上升的效果的图。图中的■表示对照组,○表示试验组1(摄取赖氨酸盐酸盐)。另外,纵轴表示血中乙醇浓度(g/L),横轴表示乙醇摄取后的经过时间(小时)。*表示在学生t检验中危险率小于5%,且表示对于对照组有显著差异。
图5是表示精氨酸抑制乙醇摄取后血中乙醇浓度上升的效果的图。图中的■表示对照组,○表示试验组1(摄取精氨酸)。另外,纵轴表示血中乙醇浓度(g/L),横轴表示乙醇摄取后的经过时间(小时)。*表示在学生t检验中危险率小于5%,且表示对于对照组有显著差异。
具体实施方式
本发明中使用的碱性氨基酸,可以列举:鸟氨酸、精氨酸、赖氨酸、组氨酸或者瓜氨酸等,优选鸟氨酸。另外,上述碱性氨基酸可以各自单独使用,也可以使用2种以上的混合物。另外,上述碱性氨基酸各自可以使用L-异构体、D-异构体、以及L-异构体和D-异构体的混合物中的任意一种,优选使用L-异构体。
作为碱性氨基酸的盐,可以列举酸加成盐、金属盐、铵盐、有机胺加成盐、氨基酸加成盐等。
作为酸加成盐,可以列举盐酸盐、硫酸盐、硝酸盐、磷酸盐等无机酸盐,醋酸盐、马来酸盐、富马酸盐、柠檬酸盐、苹果酸盐、乳酸盐、α-酮戊二酸盐、葡糖酸盐、辛酸盐等有机酸盐。
作为金属盐,可以列举钠盐、钾盐等碱金属盐,镁盐、钙盐等碱土金属盐,铵盐,锌盐等。
作为铵盐,可以列举铵、四甲基铵等的盐。
作为有机胺加成盐,可以列举吗啉、哌啶等的盐。
作为氨基酸加成盐,可以列举甘氨酸、苯丙氨酸、赖氨酸、天冬氨酸、谷氨酸等的盐。
作为本发明中使用的有机酸,可以列举醋酸、乳酸、苹果酸、富马酸、酒石酸、柠檬酸等,优选醋酸或柠檬酸,更优选柠檬酸。另外,上述有机酸可以各自单独使用,也可以使用2种以上的混合物。
本发明的组合物,除了含有上述碱性氨基酸或其盐作为有效成分之外,也可以进一步含有上述有机酸。本发明的组合物中含有有机酸的情况下,碱性氨基酸或其盐与有机酸的混合比(重量比)优选为1/0.01~100,更优选1/0.1~10,特别优选1/1~1.5。
本发明的组合物可以作为医药品或食品添加剂(以下,也称为本发明的医药或者食品添加剂)使用。
本发明的组合物作为医药使用的情况下,可以直接给用碱性氨基酸或其盐,但是通常优选以各种制剂的形式提供。
制剂含有碱性氨基酸或其盐作为有效成分,但是可以进一步含有任意的其它用于治疗的有效成分。另外,这些医药制剂可以通过将有效成分与药理学上容许的一种或一种以上的载体一起混合,并利用制剂学技术领域公知的任意方法制造。
制剂的给药方式优选使用治疗时效果最好的方式,可以列举口服给药或者例如静脉内、腹膜内或皮下给药等非口服给药,优选口服给药。
作为给药的剂型,可以是例如片剂、散剂、颗粒剂、丸剂、悬浮剂、乳剂、浸剂/煎剂、胶囊剂、糖浆剂、液体制剂、酏剂、浸膏剂、酊剂、流浸膏剂等口服剂,注射剂、滴剂、霜剂、栓剂等非口服剂中的任意一种,优选使用口服剂。
适于口服给药的例如糖浆剂这样的液体调制物,可以通过添加如下物质而制成制剂:水、蔗糖、山梨醇、果糖等糖类,聚乙二醇、丙二醇等二醇类,芝麻油、橄榄油、大豆油等油类,对羟基苯甲酸酯类等防腐剂,对羟基苯甲酸甲酯等对羟基苯甲酸衍生物,苯甲酸钠等保存剂,草莓香料、薄荷油等香料类等。
另外,适于口服给药的例如片剂、散剂和颗粒剂等,可以通过添加如下物质而制成制剂:乳糖、白糖、葡萄糖、蔗糖、甘露醇、山梨醇等糖类,马铃薯、小麦、玉米等淀粉,碳酸钙、硫酸钙、碳酸氢钙、氯化钠等无机物、结晶纤维素、甘草粉末、龙胆粉末等植物粉末等赋形剂;淀粉、琼脂、明胶粉末、结晶纤维素、羧甲基纤维素钠、羧甲基纤维素钙、碳酸钙、碳酸氢钠、褐藻酸钠等崩解剂;硬脂酸镁、滑石、氢化植物油、聚乙二醇、硅油等润滑剂;聚乙烯醇、羟丙基纤维素、甲基纤维素、乙基纤维素、羧甲基纤维素、明胶、淀粉浆液等粘合剂;脂肪酸酯等表面活性剂;甘油等增塑剂等。
适于非口服给药的例如注射剂,优选由包含与接受者的血液等渗的碱性氨基酸或其盐的灭菌水性制剂构成。例如,注射剂的情况下,使用由盐溶液、葡萄糖溶液或者盐溶液与葡萄糖溶液的混合物构成的载体制备注射用的溶液。
另外,在这些非口服剂中,也可以添加在口服剂中例示的防腐剂、保存剂、香料类、赋形剂、崩解剂、润滑剂、粘合剂、表面活性剂、增塑剂等中选择的一种或一种以上辅助成分。
本发明医药中的碱性氨基酸或其盐的浓度可以根据制剂的种类、通过给用该制剂所期待的效果等适当进行选择,作为碱性氨基酸或其盐,通常为0.1~100重量%,优选0.5~80重量%,特别优选1~70重量%。
本发明医药的给药量及给药次数根据给药方式、患者的年龄、体重、要治疗的症状的性质或严重程度而不同,通常成人每一天以碱性氨基酸或其盐计通常以50mg~30g、优选100mg~10g、特别优选200mg~3g的量一天一次至数次给药。
给药周期没有特别限制,通常为1天~1年,优选1周~3个月。
使用本发明的组合物作为食品添加剂的情况下,碱性氨基酸或其盐可以直接使用,但是,也可以通过与上述制剂同样的方法制备含有碱性氨基酸或其盐作为有效成分的食品添加剂。
本发明的食品添加剂根据需要可以混合或溶解其它食品添加剂并加工、制造为例如粉末、颗粒、丸剂、片剂、各种液体制剂的形态。
含有本发明的食品添加剂的饮食品(以下也称为本发明的饮食品),除了将本发明的食品添加剂添加到饮食品中以外,可以通过使用一般的饮食品制造方法进行加工、制造。
另外,本发明的饮食品可以使用例如流化床造粒、搅拌造粒、挤出造粒、旋转造粒、气流造粒、压缩成形造粒、破碎造粒、喷雾造粒、喷射造粒等造粒方法,锅包衣、流化床包衣、干法包衣等包衣方法,膨化干燥、过量水蒸汽法、泡沫干燥法、微波加热法等膨化方法,挤出造粒机或挤出机等挤出方法等来制造。
作为本发明的饮食品,例如可以是如下任意一种形态:果汁类、清凉饮料水、茶类、乳酸菌饮料、发酵乳、冰制食品、黄油、奶酪、酸乳、加工乳、脱脂乳等乳制品,火腿、香肠、汉堡等畜肉制品,鱼糕、鱼香肠、炸鱼肉丸等鱼肉捏合制品,肉汤煎蛋、蒸蛋豆腐等蛋制品,曲奇、果冻、口香糖、糖果、小吃等点心类,面包类、面类、腌渍物类、熏制品、干物、咸烹海味、盐腌品、汤类、调味料类等。
另外,本发明的饮食品,可以是例如粉末食品、片状食品、瓶装食品、罐装食品、蒸煮食品、胶囊食品、药片状食品、流动食品、饮剂等形态。
本发明的饮食品可以作为用于抑制血中酒精浓度上升的健康食品、功能性食品、营养辅助食品、特定保健用食品等饮食品使用。
本发明的食品添加剂或饮食品中,可以添加一般在饮食品中使用的添加剂,例如食品添加物表示手册(日本食品添加物协会,平成9年1月6日发行)中所述的甜味料、着色料、保存料、增稠稳定剂、抗氧化剂、发色剂、漂白剂、防霉剂、胶基、苦味料、酶、光泽剂、酸味料、调味料、乳化剂、强化剂、制造用剂、香料、香辣调味料提取物等。
本发明饮食品中的本发明食品添加剂的添加量可以根据饮食品的种类、通过摄取该饮食品所期待的效果等适当进行选择,以碱性氨基酸或其盐计通常以0.1~90重量%、优选0.5~80重量%、特别优选1~70重量%的含量添加。
本发明饮食品的摄取量随摄取形态、摄取者年龄、体重等而不同,通常成人一天以碱性氨基酸或其盐计通常以50mg~30g、优选100mg~10g、特别优选200mg~3g的量一次至数次给药。
摄取周期没有特别限制,通常为1天~1年,优选1周~3个月。
通过在饮酒前、饮酒中或饮酒后给用或者摄取本发明的医药或者饮食品,可以抑制血中酒精浓度上升。
以下,列出对碱性氨基酸抑制血中酒精浓度上升的效果进行研究的试验例。
试验例1
试验中,使用DBA/2Cr小鼠(雄性、7周大,自日本SLC公司购入)。饲养条件是室温22±2℃、湿度35±15%、饲料和水自由摄取。
各试验组均由5只小鼠构成,首先将乙醇以每1kg体重4g的量经口给用,30分钟后,向对照组的小鼠经口给用蒸馏水,向试验组1的小鼠经口给用制备的水溶液使得每1kg体重摄取2g的鸟氨酸盐酸盐(协和发酵工业公司制),向试验组2的小鼠经口给用制备的水溶液使得每1kg体重摄取0.935g的鸟氨酸盐酸盐和1.065g的柠檬酸(和光纯药公司制)。
从开始给用乙醇1小时后至4.5小时后,使用F-kit ethanol(ロシユ·ダイアグノステイツクス社制)测定各小鼠血液中的乙醇浓度,计算各组的平均值。另外,显著差异检验通过T检验进行。
结果如图1所示。从图1可以看出,试验组1、试验组2中给用乙醇后的血中乙醇浓度上升均受到显著抑制。另外,试验组2中,特别是给用乙醇后的90分钟以内,所述效果显著。
从以上结果可以看出,鸟氨酸具有明显的抑制血中酒精浓度上升的效果。
试验例2
在试验例1中,除了向试验组1的小鼠经口给用制备的水溶液使得每1kg体重摄取2g的组氨酸(协和发酵工业公司制)、向试验组2的小鼠经口给用制备的水溶液使得每1kg体重摄取2g的组氨酸盐酸盐(协和发酵工业公司制)以外,与试验例1同样地进行试验。
结果如图2所示。从图2可以看出,试验组1、试验组2中给用乙醇后的血中乙醇浓度上升均受到显著抑制。
从以上结果可以看出,组氨酸具有明显的抑制血中酒精浓度上升的效果。
试验例3
在试验例1中,除了向试验组1的小鼠经口给用制备的水溶液使得每1kg体重摄取2g的赖氨酸柠檬酸盐(协和发酵工业公司制)、向试验组2的小鼠经口给用制备的水溶液使得每1kg体重摄取2g的瓜氨酸(协和发酵工业公司制)以外,与试验例1同样地进行试验。
结果如图3所示。从图3可以看出,试验组1、试验组2中特别是给用乙醇后90分钟以内的血中乙醇浓度上升均受到显著抑制。
从以上结果可以看出,赖氨酸、瓜氨酸具有明显的抑制血中酒精浓度上升的效果。
试验例4
在试验例1中,除了构成对照组和试验组1两组,向试验组1的小鼠经口给用制备的水溶液使得每1kg体重摄取2g的赖氨酸盐酸盐(协和发酵工业公司制)以外,与试验例1同样地进行试验。
结果如图4所示。从图4可以看出,试验组1中给用乙醇后的血中乙醇浓度上升受到显著抑制。
从以上结果可以看出,赖氨酸具有明显的抑制血中酒精浓度上升的效果。
试验例5
在试验例1中,除了构成对照组和试验组1两组,向试验组1的小鼠经口给用制备的水溶液使得每1kg体重摄取1g的精氨酸(协和发酵工业公司制)以外,与试验例1同样地进行试验。
结果如图5所示。从图5可以看出,试验组1中特别是给用乙醇后90分钟以内的血中乙醇浓度上升受到显著抑制。
从以上结果可以看出,精氨酸具有明显的抑制血中酒精浓度上升的效果。
以下列出本发明的实施例。
实施例1
含有鸟氨酸的片剂的制造
使用锥形掺合机(日本干燥机株式会社制,CB-1200型掺合机)将鸟氨酸盐酸盐136.2kg(协和发酵工业公司制,L-鸟氨酸盐酸盐)、微晶纤维素36.0kg(旭化成化学公司制,Avicel FD101)、蔗糖脂肪酸酯6.6kg(第一工业制药公司制,DK Ester F-20W)、磷酸钙1.2kg(太平化学产业公司制,磷酸三钙)和β-环糊精20.0kg(日本食品化工公司制,Celldex B-100)混合。使用旋转压缩成形机(菊水制作所社制,VIRGO524SS1AY)以压缩成形压力10kN将得到的混合物压缩成形,制备了直径8mm、250mg的片剂。
实施例2
含有鸟氨酸和柠檬酸的片剂的制造
将用奈良机械制作所制造的M-2型(筛0.5mm)粉碎的柠檬酸(協和ハイフ一ズ社制)1000g、鸟氨酸盐酸盐1000g和还原麦芽糖浆(林原商事社制,粉末マビツト50M)2747.5g的混合物使用水以流化床造粒干燥机(フロイント産業社制,FLO-5)进行造粒。在得到的造粒物4557.6g中混入三氯蔗糖(三荣源FFI公司制)2.4g和蔗糖脂肪酸酯(长濑产业公司制,DK Ester F-20W)240g。使用旋转压缩成形机以压缩成形压力10kN将得到的混合物压缩成形,制备了直径9mm、300mg的片剂。
实施例3
含有鸟氨酸和柠檬酸的饮料的制造
将鸟氨酸盐酸盐1.28kg、赤藓醇3kg(日研化学公司制)、柠檬酸0.05kg、人造甜味料3g、香料0.06kg在液温70℃的水50L中搅拌溶解,用柠檬酸将pH调至3.3后,使用板式(プレ一ト)杀菌进行灭菌并装瓶后,进行巴式灭菌,制备了含有鸟氨酸和柠檬酸的饮料。
产业实用性
根据本发明,可以提供含有碱性氨基酸或其盐作为有效成分的安全有效的血中酒精浓度上升抑制用组合物。
Claims (3)
1.鸟氨酸、精氨酸、组氨酸或者瓜氨酸或者它们的盐用于制造血中酒精浓度上升抑制用组合物的应用。
2.权利要求2所述的应用,包括进一步使用有机酸。
3.权利要求3所述的应用,其中,有机酸为醋酸、乳酸、苹果酸、富马酸、酒石酸或柠檬酸。
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