CN101505774B - 含有来自金合欢属树皮的物质的搔痒预防和/或治疗用组合物 - Google Patents
含有来自金合欢属树皮的物质的搔痒预防和/或治疗用组合物 Download PDFInfo
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- CN101505774B CN101505774B CN2006800555812A CN200680055581A CN101505774B CN 101505774 B CN101505774 B CN 101505774B CN 2006800555812 A CN2006800555812 A CN 2006800555812A CN 200680055581 A CN200680055581 A CN 200680055581A CN 101505774 B CN101505774 B CN 101505774B
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- acacia
- bark
- itches
- extract
- scratching
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Abstract
本发明提供用于搔痒的预防或治疗的组合物。该搔痒的预防和/或治疗用组合物的特征在于含有来自金合欢属树皮的物质。
Description
技术领域
本发明涉及来自金合欢属(Acacia)树木的搔痒预防和/或治疗用组合物以及该组合物作为食品、动物饲料、药品和准药品(quasi drug)的用途。
背景技术
搔痒即发痒是很不舒服的感觉，有时会影响日常生活。搔痒的产生原因各式各样，例如异位性皮炎、老年皮肤搔痒症、荨麻疹、湿疹、虫咬、皮肤干燥以及斑疹等皮肤疾病、肾病、糖尿病、胶原性疾病、老龄及温热寒冷刺激等。若将搔痒部位抓破等，则会导致症状进一步恶化或产生更强烈的搔痒这样的恶性循环。
例如异位性皮炎，已知在出汗、抓破、摩擦等的外界刺激下容易恶化，因此搔痒成为最重要的治疗目标。
因此，在治疗上述皮肤疾病的过程中，首要的是进行抑制搔痒的处理。
作为针对搔痒的处理方法，已知有各种内服疗法和外用疗法。例如，在内服疗法中，利用苯海拉明、马来酸氯苯那敏、美喹他嗪、酮替芬、氮卓斯汀、奥沙米特、特非那丁、依匹斯汀等抗组胺剂、曲尼司特、Suplatast等抗过敏剂等。在外用疗法中，利用凡士林、尿素、肝素等保湿剂、苯海拉明、马来酸氯苯那敏等抗组胺剂、地塞米松、氢化可的松等甾体剂、克罗米通等止痒剂、地布卡因、利多卡因等局部麻醉剂等。
关于金合欢，已知金合欢蜂蜜以及从其树皮提取的丹宁可以用作鞣皮剂和木材用胶粘剂，而且最近公开了金合欢属的提取物具有COX-2的选择性抑制效果(专利文献1)、金合欢属的树皮具有活性氧清除效果(专利文献2)以及酪氨酸酶活性抑制效果产生的美白效果(专利文献3)。但是，并不知道金合欢属的树皮和来自树皮的多酚具有抗搔痒效果。
专利文献1：日本专利特表2004-532811号公报
专利文献2：日本专利特开2004-352639号公报
专利文献3：日本专利特开平10-025238号公报
发明内容
本发明提供安全性高的、优异的搔痒的预防和/或治疗用组合物。
本发明人等为了解决上述技术问题，进行了潜心研究，结果发现来自金合欢属树皮的物质对搔痒有效果，从而完成了本发明。
即，本发明涉及搔痒的预防和/或治疗用组合物，其特征在于，含有来自金合欢属树皮的物质。
本发明还涉及使用来自金合欢属树皮的物质的搔痒的预防和/或治疗方法。
此外，本发明还涉及用于制造搔痒的预防和/或治疗用组合物的来自金合欢属树皮的物质的使用方法。
本发明的组合物具有抗搔痒效果或止痒效果，预防搔痒的发生，并且能治愈或减轻搔痒，因而可以用于搔痒的预防和/或治疗。
本发明的组合物即使长期服用也不必太担心副作用等，安全性高。
具体实施方式
本发明可使用的来自金合欢属树皮的物质，只要是以属于金合欢属(Acacia)的树木(以下称为“金合欢”或“金合欢属”)的树皮为原料而得到的物质即可，没有特殊限制，例如可以列举金合欢属的树皮的碎片、粉末及它们的悬浮液、金合欢属的树皮的提取液、浓缩提取液、及提取粉末等提取物以及将该提取物精制得到的精制物。从能得到优异的抗搔痒效果的观点出发，优选金合欢属树皮的提取物，特别优选金合欢树皮多酚。
在本发明中，可以只使用1种来自上述金合欢属树皮的物质，也可以并用2种以上。
本发明可使用的金合欢，只要是属于金合欢属的树木即可，没有特殊限制，从得到具有优异的抗搔痒效果的来自金合欢属树皮的物质的观点出发，优选从由学名：Acaciamearnsii De Wild.(俗名：黑荆树)、学名：Acaciamangium Willd。俗名：马占相思)、学名：Acacia dealbata Link、学名：Acacia decurrens Willd.、以及学名：Acacia pycnantha Benth.构成的组中选择的金合欢属的树皮，特别优选Acacia mearnsii De Wild.以及Acaciamangium Willd.。
在本发明中，可以只使用1种上述金合欢属的树皮，也可以并用2种以上。
上述金合欢属的树皮，通常可通过将树木采伐后只剥离树皮并采取干燥来得到，优选进一步在阳光下干燥得到的树皮。
金合欢属的树皮由外皮和略有纤维性的内皮构成，干燥至含水率为20％左右以下时，在锤式粉碎机等粉碎机中易微粉化。在本发明中，作为金合欢属的树皮，可以将该金合欢属的内皮和外皮两者一起使用，也可以只使用任一方。
上述金合欢属的树皮的碎片，可以通过用常法将金合欢属的树皮粉碎成合适的大小来获得。
上述金合欢属的树皮的粉末，可以通过将金合欢属的树皮用常法粉碎而粉末化来获得，特别优选粒径为100μm以下、尤其是50μm～70μm的粉末。关于粉末的区分，将干燥至含水率为20％以下的树皮粉碎成合适的大小例如粒径为1.6mm以下左右，再将得到的粉末用振动筛等分级，即可得到所需的粉末。
上述金合欢属的树皮的提取物，可以通过将金合欢属的树皮用常法提取来获得。为了得到具有优异的抗搔痒效果的金合欢属树皮的提取物，优选用醇或极性溶剂对金合欢属的树皮进行提取。
作为上述醇，可以使用乙醇，作为极性溶剂，可以使用水等，还可以根据需要单独使用这些溶剂或并用2种以上。特别是为了得到优异的抗搔痒效果，优选水与乙醇等醇的混合溶剂。
此外，也可以用相同或不同的溶剂进行多次提取操作。
为了得到具有优异的抗搔痒效果的提取物，也可以使用通过将来自金合欢属树皮的经水或热水得到的提取物进一步用乙醇提取得到的提取物。
关于提取，在金合欢属树皮的碎片或粉末等中加入溶剂并根据需要搅拌来提取，对温度和时间或固液比没有特殊限制。当溶剂采用水时，可以用热水来提取。得到的提取液可以直接冷冻干燥或喷雾干燥，或者也可以在减压浓缩后冷冻干燥或喷雾干燥。得到的提取物可以为提取液、溶液、粉末、浓缩液、糊状物等各种形态，可以根据需要广泛使用。
此外，以上述形态得到的本发明的金合欢属树皮提取物可以直接用于搔痒的预防或治疗，还可以根据需要精制，该精制物也可以作为抗搔痒活性成分使用。
在本发明中，作为来自金合欢属树皮的物质，还可以例示在金合欢属的树皮中含有的成分。作为这样的成分，可以例示金合欢树皮多酚等。特别是金合欢树皮多酚显示出优异的抗搔痒效果，因而为优选的成分。
本发明的金合欢树皮多酚是指(-)-非瑟酮醇、(-)-刺槐亭醇、(+)-儿茶素以及(+)-没食子儿茶素等以黄烷-3-醇为基本骨架的黄烷醇类以C4-C8、C4-C6结合而成的聚合物即缩合型丹宁的一种。这里，作为这种缩合型丹宁，优选分子量为300～3000，特别优选500～3000。本发明使用的金合欢树皮多酚可以通过将上述金合欢属树皮的粉末等进行热水提取来获得。
作为金合欢树皮多酚产品，可以例示MIMOSA Central Co-operativeLtd.制的注册商标为MIMOSA MEPOWDER、MIMOSA MS POWDER、MIMOSA GSPOWDER、MIMOSA FS POWDER、MIMOSA WS POWDER、MIMOSA RG POWDER、MIMOSA RN POWDER、MIMOSADKPOWDER、MIMOSA AL POWDER、MIMOSA CR POWDER、GOLDENMIMOSA POWDER的产品等。
本发明的组合物可以是来自金合欢属树皮的物质，例如金合欢属的树皮、其提取物、其精制物、或金合欢树皮多酚，也可以是含有其他具有抗搔痒效果的物质，例如克罗米通等抗组胺剂、抗过敏剂、姜黄、田七人参、KW乳酸菌、玛咖(MACA)或艾蒿乳液。特别是从利用协同作用得到优异的抗搔痒效果的观点出发，优选含有抗组胺剂、抗过敏剂、姜黄、田七人参或KW乳酸菌。
本发明的组合物可以是来自金合欢属树皮的物质，例如金合欢属的树皮、其提取物、其精制物、或金合欢树皮多酚，在不损坏本发明效果的前提下，可以含有赋形剂、甜味剂、酸味剂、增粘剂、香料、色素、乳化剂及其他在药品及食品中常用的添加剂及材料。
本发明的组合物可以用于搔痒的预防或治疗。作为上述搔痒，可以例示湿疹、皮炎、荨麻疹、痒疹(prurigo nodularis)以及搔痒症等皮肤病引起的皮肤搔痒。具体而言，可以例示异位性皮炎、接触性皮炎、主妇湿疹、手湿疹、尿布皮炎、脂漏性皮炎、老年皮肤搔痒症、痒疹、斑疹、老年干皮症、皮脂缺乏性湿疹、虫咬、大腿部白癣、足部白癣以及花粉症引起的眼睑炎等皮肤病引起的皮肤搔痒。另外，本发明的组合物对感觉异常性背痛(notalgia paresthetica)、肾功能不全治疗用血液透析(hemodialysi)引起的搔痒、伴随发痒的干癣(psoriasis)也有用。
本发明的组合物对于过敏等免疫异常引起的搔痒、例如荨麻疹、异位性皮炎、接触性皮炎、伴随花粉症产生的眼睑炎、尤其是异位性皮炎和伴随花粉症产生的眼睑炎特别有用。
另外，在本发明中，治疗包含消除搔痒、减轻症状、治愈、抑制恶化等。
本发明的组合物的摄取量没有特殊限制，可以根据剂型以及使用者或患者等摄取者或摄取动物的年龄、体重及症状来适当选择。例如，相对于每1kg摄取者的体重或摄取动物的体重，作为有效成分量而每日口服摄取0.001g～1g、优选为0.001g～0.5g、更优选为0.005g～0.1g的金合欢树皮多酚量，能得到优异的抗搔痒效果，因而优选。
摄取时间可以根据摄取者或摄取动物的年龄、症状来任意设定。
本发明的组合物作为食品或动物饲料而言，可以作为例如健康食品、功能性食品、健康补助食品、特定保健用食品、美容食品以及营养补助食品(营养补充剂)来使用。这些食品和动物饲料例如可以是茶、果汁等饮料；冰激淋、果冻、糖果、巧克力以及口香糖等的形态。另外，也可以是液体制剂、粉剂、颗粒剂、胶囊剂或片剂的形态。这里，动物饲料的动物包含包括宠物动物、畜产动物或动物园等中饲养的动物在内的需要预防或治疗搔痒的所有动物。
本发明的组合物可以作为药品或准药品使用。这些药品或准药品能以例如散剂、片剂、包衣剂、糖衣剂、硬明胶胶囊或软明胶胶囊剂、液体制剂、乳浊剂或悬浮剂的形态口服给药，也可以非口服给药，例如以栓剂的形态直肠给药；例如以软膏、霜剂、凝胶剂或液体制剂的形态局部或经皮给药。
以下，列举实施例更详细地具体说明本发明，但本发明不限于这些。
[实施例]
以下，列举制造例、试验例、掺和例来更详细地具体说明本发明，但本发明不限于这些。特别是这里虽然未将本发明的金合欢属树皮分为外皮和内皮来示出实施例，但也可以将外皮从内皮分离而分别使用。
在以下的制造例、试验例等中，将本发明的各金合欢用各自学名后的括号内所示的号来表示。例如，将学名：Acacia mearnsii De Wild.的金合欢记作金合欢No.1。
学名：Acacia mearnsii De Wild.(No.1)、学名：Acacia mangium Willd.(No.2)、学名：Acacia dealbata Link(No.3)、学名：Acacia decurrens Willd.(No.4)、学名：Acacia pycnantha Benth.(No.5)。
另外，％在没有特殊说明的情况下表示重量％。
金合欢树皮粉末的制造例1
将金合欢No.1的树皮干燥至含水率为20％以下，将该干燥树皮用锤式粉碎机粉碎成1.6mm以下(过10目筛(泰勒：Tyler))的粉末，然后再用振动筛分级，得到63μm以下(过250目筛)的微粉。
同样操作，将其余4种金合欢No.2～5的树皮粉碎，分别得到63μm以下的微粉。因种类不同，过250目筛的微粉的收率多少存在差异，但均得到了目标微粉。
金合欢树皮提取物的制造例2
将本发明的各金合欢No.1～5的树皮分别干燥至含水率为20％以下，将该干燥树皮用锤式粉碎机粉碎至1.6mm以下的粉末后，相对于该干燥粉碎树皮100g加入5倍量的热水，沸腾后提取15分钟，用10μm～20μm的过滤器过滤。将得到的滤液用喷雾干燥器进行喷雾干燥，得到树皮提取物各40g。
以下，各树皮提取物记作金合欢No.1～5热水提取物。
金合欢树皮提取物的制造例3
将本发明的金合欢树皮干燥至含水率为20％以下，将该干燥树皮用锤式粉碎机粉碎至1.6mm以下的粉末后，相对于该干燥粉碎树皮100g加入5倍量的乙醇，一边沸腾回流一边提取15分钟，用10μm～20μm的过滤器过滤。从得到的滤液蒸发乙醇，将浓缩液用封闭式喷雾干燥器进行喷雾干燥，得到树皮提取物(以下记为金合欢No.1乙醇提取物)40g。
同样操作，得到金合欢No.1～5的乙醇提取物。
金合欢树皮提取物的制造例4
在制造例2中得到的金合欢热水提取物10g中加入3倍量的乙醇，一边沸腾回流一边提取15分钟，用10μm～20μm的过滤器过滤。从得到的滤液中蒸发乙醇，在其中加水后冷冻干燥，得到9g提取物(以下记为金合欢No.1热水提取物乙醇馏分)。
同样操作，得到金合欢No.1～5的热水提取物乙醇馏分。
试验例1皮肤搔痒行为抑制试验(1)
(1)试验方法
按所需量称取上述制造例2所述的金合欢No.1热水提取物，与普通饲料混合，制备含有1.5％该金合欢No.1热水提取物的试验饲料1。
将5周龄的ddY小鼠分成3组(每组6～8只)，即普通饲料组、compound处理组以及试验饲料1组。对普通饲料组和compound处理组给予普通饲料，对试验饲料1组给予试验饲料1。
在开始摄取饲料后的第28天(4周)、第35天(5周)以及第42天(6周)测定小鼠的搔痒行为。对compound处理组和试验饲料1组皮下给予0.5mg/kg(20μg/只)Compound48/80(Sigma公司制)。然后，将该小鼠分别装入塑料容器中，录像拍摄上述Compound48/80给予后30分钟的小鼠的搔痒行为。从拍摄到的画面来计算小鼠的搔痒行为的次数。将搔痒行为分为左右后肢对颈背部的挠痒行为(以下称为“抓挠”)、前肢对头部的理毛行为(以下称为“修饰”)、从腹部舔舐到背部的行为(以下称为“舔舐行为”)这三类，将各自的次数作为每5分的累计次数来计算。
上述得到的测定值用平均值±标准误差来表示。用Bartlett法进行等分散性检验，为等分散性时，进一步用ANOVA进行检验，仅在ANOVA显著的情况下，进一步用Tukey法进行平均值的比较。在Bartlett法中为非等分散性时，进行Kruskal-Wallis的H检验，仅在显著的情况下，进一步用Tukey法进行平均值的比较。显著水平为5％。
(2)试验结果
结果如表1所示。
表1试验饲料对搔痒行为的作用
()表示与Compound处理组比较的减少率(％)。
**是与Compound处理组的值的比较。P＜0.01。
试验例2皮肤搔痒行为抑制试验(2)
(1)试验方法
根据Makiura M.，et.al：J.Int.Med.Res.，2004，32(4)：392-399中记载的方法进行该试验。
按所需量称取上述制造例2记载的金合欢No.1热水提取物，与特殊饲料(HR-AD用精制饲料、日本农产工业株式会社制)混合，分别制备该金合欢No.1热水提取物为0.5％、1.5％以及5.0％的混合试验饲料。
将5周龄的Hos：HR-1雄性小鼠(从株式会社星野试验动物研究所购入)分成5组(每组6～8只)。对各组分别给予普通饲料、特殊饲料或金合欢No.1热水提取物混合饲料。
在开始摄取饲料后第28天(4周)、第35天(5周)以及第42天(6周)对小鼠的搔痒行为进行30分钟录像拍摄。与上述试验例1同样从画面计算小鼠的搔痒行为的次数。
测定值用平均值和标准偏差表示。
(2)试验结果
各搔痒行为的累计次数的计算结果如表2所示。
试验例1和2表明：金合欢树皮多酚对皮肤搔痒有效。
试验例3突变诱发性试验
根据劳动省告示第77号(1988年9月1日)，实施突变诱发性试验。用156μg/板～5000μg/板的剂量的样品(制造例2的金合欢No.1～5热水提取物)进行试验，结果任一菌株的回复突变菌落数均未增加。
试验例4微核(micronucleus)试验
按照常法，分析体内微核诱发能力的有无。向雄性ICR系小鼠以2000mg/kg、1000mg/kg及500mg/kg的每日剂量间隔24小时口服给予2次金合欢No.1热水提取物，在最终给予24小时后，制作微核标本。
金合欢No.1热水提取物的任一剂量均未显示阳性。同时观察的总多染性红细胞相对于总红细胞的比没有一定的变动，与阴性对照组相比，未见红细胞的增殖抑制。
试验例5小鼠急性毒性试验(口服给药)
根据OECD(Guidelines for the Testing of Chemicals 401，1987)，用ICR系雌雄小鼠进行急性口服毒性试验。其结果是，金合欢No.1热水提取物的LD50值在雄小鼠中为4468mg/kg，在雌小鼠中为3594mg/kg。
对制造例2的金合欢No.2～5热水提取物进行上述试验，得到同样的结果。
试验例6大鼠反复给药毒性试验(口服给药)
根据常法，用大鼠进行13周反复给药毒性试验。
向Slc：SD大鼠的雌雄大鼠给予含有0.5％、1.5％以及5.0％金合欢No.1热水提取物的混合饲料。
其结果是，没有大鼠死亡的例子。在包含一般状态的检查中未见异常。
试验例7人单次给药试验
让32岁～43岁的健康成年男性5名摄取1500mg(12片下述掺和例4的片剂)金合欢No.1热水提取物，在摄取前·摄取3小时后·摄取8小时后·摄取24小时后·摄取1周后，实施一般检查·血液学检查·血液生化学检查·尿检，没有成为临床问题的检测值的变动。也没有与片剂相关的有害现象。试验例8人4周连续给药试验
让23岁～44岁的健康成年男性25名分别摄取4周750mg/日(6片掺和例4的片剂)以及1000mg/日(8片掺和例4的片剂)下述掺和例4的金合欢No.1热水提取物。
在各组的摄取前、摄取2周后、摄取4周后、摄取结束2周后，实施一般检查、血液检查、尿检。没有有问题的检测值的变动。也没有有害现象。
掺和例1内服制剂的制备
使用制造例4的金合欢树皮热水提取物乙醇馏分，按下述所示的组成，制备内服制剂。
掺和例2宠物食品的制备
使用制造例2的金合欢树皮热水提取物，按下述所示的组成制备宠物食品。
掺和例3片剂(点心)的制备
使用制造例4的金合欢树皮热水提取物乙醇馏分，按下述所示的组成制备片剂(点心)。
掺和例4片剂的制备
使用制造例2的金合欢树皮No.1热水提取物，按下述所示的组成制备片剂。
工业上利用的可能性
根据本发明可得到搔痒的预防和/或治疗用组合物。
更详细而言，本发明的组合物对于过敏疾病中的搔痒的预防和/或治疗有用。
这些组合物可以用于药品、准药品、化妆品、或健康食品、健康补助食品、特定保健用食品或营养补助食品等食品或动物饲料。
Claims (7)
1.Acacia mearnsii De Wild.树皮的提取物在搔痒的预防和/或治疗用组合物的制造中的应用，其中所述提取物是以水作为溶剂时所得的提取物、以醇作为溶剂时所得的提取物、以水与醇的混合溶剂作为溶剂时所得的提取物、或者经以水作为溶剂时所得的提取物进一步用以乙醇作为溶剂时提取得到的提取物。
2.根据权利要求1所述的应用，其中，所述以水作为溶剂时所得的提取物是以热水作为溶剂时所得的提取物。
3.根据权利要求1或2所述的应用，所述搔痒的预防和/或治疗用组合物为食品。
4.根据权利要求1或2所述的应用，所述搔痒的预防和/或治疗用组合物为药品。
5.根据权利要求1或2所述的应用，所述搔痒的预防和/或治疗用组合物为准药品。
6.根据权利要求1或2所述的应用，所述搔痒的预防和/或治疗用组合物为动物用饲料。
7.根据权利要求1或2所述的应用，所述搔痒的预防和/或治疗用组合物为化妆品。
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