CN110944521A - 用于治疗糖尿病患者中高血糖症的组合物 - Google Patents
用于治疗糖尿病患者中高血糖症的组合物 Download PDFInfo
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- CN110944521A CN110944521A CN201880034724.4A CN201880034724A CN110944521A CN 110944521 A CN110944521 A CN 110944521A CN 201880034724 A CN201880034724 A CN 201880034724A CN 110944521 A CN110944521 A CN 110944521A
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Abstract
本发明提供了用于降低1型和2型糖尿病患者中升高的血糖水平(高血糖症)的组合物,其包含至少一种甜菊糖苷。
Description
发明背景
由于人们认识到许多疾病与消费高糖食品和饮料相关,因此糖替代品正受到越来越多的关注。其中之一就是糖尿病,据信它将影响全球约8.5%的成年人口,而且病例数仍在上升。糖尿病有2种类型-1型和2型,其中2型是最常见的,占所有病例的90%。
糖尿病患者最常见的症状是血糖水平升高(高血糖症)。典型地,通过施用胰岛素(1型)或其他抗糖尿病药物(2型)来降低血糖水平,所述其他抗糖尿病药物来自化合物组,包括双胍类,噻唑烷二酮,促分泌剂,磺酰脲类,非磺酰脲类促泌剂等。
糖尿病处置的另一个重要部分在于生活方式的改变,其包括饮食中少摄入单糖(例如葡萄糖,蔗糖,果糖等)。糖替代品(甜味剂)被广泛用于改善此类饮食的感官特性(主要是通过赋予甜味)。
由于担心安全性,一些国家禁止或限制了许多合成(人造)甜味剂,例如甘素、环拉酸钠和糖精。因此,天然来源的无热量甜味剂变得越来越流行。甜味草药甜叶菊(Steviarebaudiana)产生大量的二萜糖苷,其以
高强度甜味和感官特性为特征,优于许多其他高效甜味剂。
甜叶菊是一种属于Astracea科的植物,原产于南美,现已在世界许多地方种植(Gardana等人,2003;Koyama等人,2003;Carakostas等人,2008)。甜菊属(Stevia)叶具有天然甜味,在南美已被用于甜味食品中数百年(Soejarto等人,1982)。在日本和其他东南亚国家,甜菊属提取物已在商业上用于增甜食品多年(Koyama等人,2003)。作为自然产物,甜菊属植物的叶子含有不同的甜味成分,称为甜菊糖苷(steviol glycoside)。据报道,已经鉴定出典型地存在于甜菊属叶提取物中的40种以上甜菊糖苷(Ceunen和Geuns,2013;Chaturvedula等人,2011a,b,c;Chaturvedula和Prakash,2011a,b;Ohta等人,2010)。这些甜菊糖苷中的每一种都有其独特的味道和甜度,其甜度可比糖高多至350倍,但都具有相似的分子结构,其中不同的糖基团连接至糖苷配基甜菊醇(aglycone steviol,一种内部-贝壳杉烯型二萜烯)。
甜菊属植物的叶子含有二萜糖苷的混合物,其含量为总干重的约10%-15%。这些二萜糖苷的甜度约为糖的30-450倍。在结构上,二萜糖苷的特征在于常见的糖苷配基-甜菊醇,而其不同之处在于甜菊醇C13和C19位上存在碳水化合物残基。典型地,以干重计,在甜菊属叶中发现的四种主要甜菊糖苷为甜甙A(0.3%)、甜叶菊甙C(0.6-1.0%)、甜叶菊甙A(3.8%)和卡哈苡苷(9.1%)。其他甜菊糖苷包括在FDA GRAS Notice(GRN)第619号(2016年2月2日提交)中列出的那些,其全部内容通过引用结合于此。其他甜菊糖苷的非限制性实例包括甜叶菊甙(rebaudioside)B、D、E、F、M、N、O、甜菊双糖甙(steviolbioside)、悬钩子甙(rubusoside)等。
迄今为止,甜菊糖苷的应用仅限于包括食品和饮料在内的各种消费品中的甜味剂和香味成分。
另一方面,仍然需要开发含有天然化合物的口服可摄取的组合物,该组合物将提供与糖尿病治疗中使用的许多药物相似的药理学作用(降血糖)。
发明内容
本发明一般性涉及包含至少一种甜菊糖苷的组合物和包含该组合物的消费品,以及使用这类组合物和消费品用于治疗患有1型和2型糖尿病的患者的方法。
本发明的甜菊糖苷的非限制性实例包括甜叶菊甙A、甜叶菊甙B、甜叶菊甙C、甜叶菊甙D、甜叶菊甙E、甜叶菊甙F、甜叶菊甙G、甜叶菊甙H、甜叶菊甙I、甜叶菊甙J、甜叶菊甙K、甜叶菊甙L、甜叶菊甙M、甜叶菊甙N、甜叶菊甙O、甜甙A、甜菊双糖甙、悬钩子甙、FDA GRASNotice(GRN)第619号(2016年2月2日提交)中列出的甜菊糖苷、糖基化甜菊糖苷、α-葡萄糖基化甜菊糖苷(GSG)、果糖基化甜菊糖苷、半乳糖基化甜菊糖苷,以及其他在甜叶菊植物中发现的或通过化学、酶合成或通过重组微生物发酵及其组合制备的甜菊糖苷,其中所述组合包含2-100种不同的甜菊糖苷分子,且其中每种糖苷与全部甜菊糖苷的总%w/w含量的%w/w比在0.0000001%-99.9999999%的范围,更优选等于约0.0001%、0.001%、0.01%、0.05%、0.1%、0.2%、0.3%、0.4%、0.5%、0.6%、0.7%、0.8%、0.9%、1%、1.5%、2%、3%、4%、5%、6%、7%、8%、9%、10%、11%、12%、13%、14%、15%、16%、17%、18%、19%、20%、21%、22%、23%、24%、25%、26%、27%、28%、29%、30%、31%、32%、33%、34%、35%、36%、37%、38%、39%、40%、41%、42%、43%、44%、45%、46%、47%、48%、49%、50%、51%、52%、53%、54%、55%、56%、57%、58%、59%、60%、61%、62%、63%、64%、65%、66%、67%、68%、69%、70%、71%、72%、73%、74%、75%、76%、77%、78%、79%、80%、81%、82%、83%、84%、85%、86%、87%、88%、89%、90%、91%、92%、93%、94%、95%、96%、97%、98%、99%、99.9%。
详细描述
本发明某些甜菊糖苷的化学结构在FDA GRAS Notice(GRN)No.619(02-Feb-16提交)中提供,而另外的化学结构由本领域技术人员从文献中知晓。
本发明的甜菊糖苷分离自甜菊属(Stevia)植物,或者例如用重组微生物、植物发酵和用酶生物转化生产。
本发明的一个实施方案为用于降低1型和2型糖尿病患者中升高的血糖水平(高血糖症)的液体或固体组合物,其包含至少一种甜菊糖苷,其中该组合物包含0.0000001%-99.9999999%(w/w,以干重计),更优选0.0001%、0.001%、0.01%、0.05%、0.1%、0.2%、0.3%、0.4%、0.5%、0.6%、0.7%、0.8%、0.9%、1%、1.5%、2%、3%、4%、5%、6%、7%、8%、9%、10%、11%、12%、13%、14%、15%、16%、17%、18%、19%、20%、21%、22%、23%、24%、25%、26%、27%、28%、29%、30%、31%、32%、33%、34%、35%、36%、37%、38%、39%、40%、41%、42%、43%、44%、45%、46%、47%、48%、49%、50%、51%、52%、53%、54%、55%、56%、57%、58%、59%、60%、61%、62%、63%、64%、65%、66%、67%、68%、69%、70%、71%、72%、73%、74%、75%、76%、77%、78%、79%、80%、81%、82%、83%、84%、85%、86%、87%、88%、89%、90%、91%、92%、93%、94%、95%、96%、97%、98%、99%、99.9%的甜菊糖苷及其组合。
本发明的另一个实施方案为用于降低1型和2型糖尿病患者中升高的血糖水平(高血糖症)的口服可摄取的液体或固体消费品,其包含至少一种甜菊糖苷组合物,其中所述口服可摄取的液体或固体消费品包含0.0000001%-99.9999999%(w/w,以干重计),更优选0.0001%、0.001%、0.01%、0.05%、0.1%、0.2%、0.3%、0.4%、0.5%、0.6%、0.7%、0.8%、0.9%、1%、1.5%、2%、3%、4%、5%、6%、7%、8%、9%、10%、11%、12%、13%、14%、15%、16%、17%、18%、19%、20%、21%、22%、23%、24%、25%、26%、27%、28%、29%、30%、31%、32%、33%、34%、35%、36%、37%、38%、39%、40%、41%、42%、43%、44%、45%、46%、47%、48%、49%、50%、51%、52%、53%、54%、55%、56%、57%、58%、59%、60%、61%、62%、63%、64%、65%、66%、67%、68%、69%、70%、71%、72%、73%、74%、75%、76%、77%、78%、79%、80%、81%、82%、83%、84%、85%、86%、87%、88%、89%、90%、91%、92%、93%、94%、95%、96%、97%、98%、99%、99.9%的甜菊糖苷及其组合。
本发明的另一个实施方案为降低1型和2型糖尿病患者中升高的血糖水平(高血糖症)的方法,通过口服摄取包含至少一种甜菊糖苷的液体或固体组合物来进行,其中该组合物包含0.0000001%-99.9999999%(w/w,以干重计),更优选0.0001%、0.001%、0.01%、0.05%、0.1%、0.2%、0.3%、0.4%、0.5%、0.6%、0.7%、0.8%、0.9%、1%、1.5%、2%、3%、4%、5%、6%、7%、8%、9%、10%、11%、12%、13%、14%、15%、16%、17%、18%、19%、20%、21%、22%、23%、24%、25%、26%、27%、28%、29%、30%、31%、32%、33%、34%、35%、36%、37%、38%、39%、40%、41%、42%、43%、44%、45%、46%、47%、48%、49%、50%、51%、52%、53%、54%、55%、56%、57%、58%、59%、60%、61%、62%、63%、64%、65%、66%、67%、68%、69%、70%、71%、72%、73%、74%、75%、76%、77%、78%、79%、80%、81%、82%、83%、84%、85%、86%、87%、88%、89%、90%、91%、92%、93%、94%、95%、96%、97%、98%、99%、99.9%的甜菊糖苷及其组合。
本发明的另一个实施方案为降低1型和2型糖尿病患者中升高的血糖水平(高血糖症)的方法,通过口服摄取包含至少一种甜菊糖苷组合物的液体或固体消费品来进行,其中所述液体或固体消费品包含0.0000001%-99.9999999%(w/w,以干重计),更优选0.0001%、0.001%、0.01%、0.05%、0.1%、0.2%、0.3%、0.4%、0.5%、0.6%、0.7%、0.8%、0.9%、1%、1.5%、2%、3%、4%、5%、6%、7%、8%、9%、10%、11%、12%、13%、14%、15%、16%、17%、18%、19%、20%、21%、22%、23%、24%、25%、26%、27%、28%、29%、30%、31%、32%、33%、34%、35%、36%、37%、38%、39%、40%、41%、42%、43%、44%、45%、46%、47%、48%、49%、50%、51%、52%、53%、54%、55%、56%、57%、58%、59%、60%、61%、62%、63%、64%、65%、66%、67%、68%、69%、70%、71%、72%、73%、74%、75%、76%、77%、78%、79%、80%、81%、82%、83%、84%、85%、86%、87%、88%、89%、90%、91%、92%、93%、94%、95%、96%、97%、98%、99%、99.9%甜菊糖苷及其组合。
口服可摄取的消费品的非限制性实例包括:药物,药物制剂,化妆品,包括但不限于牙膏,漱口水,止咳糖浆,可咀嚼片剂,锭剂,维生素制剂等,食品和饮料产品,包括但不限于碳酸软饮料,可乐风味碳酸软饮料,水果风味碳酸软饮料,浆果风味碳酸软饮料,即饮饮料,能量饮料,等渗饮料,低热量饮料,零热量饮料,运动饮料,茶,水果和蔬菜汁,果汁饮料,乳制品饮料,酸奶饮料,酒精饮料,粉状饮料,烘焙产品,曲奇饼干,饼干,烘焙混合物,谷物,糖食,糖果,巧克力,太妃糖,口香糖,乳制品,香味奶,酸奶,加香酸奶,酸牛奶,酱油和其他大豆基料产品,色拉酱,蛋黄酱,醋,冷冻甜点,肉类产品,鱼肉产品,瓶装食品和罐装食品,餐桌用甜味剂(tabletop sweetener),水果和蔬菜。
本发明的甜菊糖苷组合物可以以其本身使用或与另外的甜味剂、香料和食品成分组合使用。
甜味剂的非限制性实例包括罗汉果提取物、罗汉果甙、糖基化罗汉果甙、高果糖玉米糖浆、玉米糖浆、转化糖、低聚果糖、菊糖、低聚菊糖(inulooligosaccharide)、偶联糖、麦芽低聚糖、麦芽糖糊精、糊精、受限性糊精(limited dextrins)、玉米糖浆固体、葡萄糖、麦芽糖、蔗糖、乳糖、阿洛酮糖、塔格糖、阿司帕坦、糖精、三氯蔗糖、糖醇及其混合物。
香料的非限制性实例包括可乐,柠檬,酸橙,橙子,葡萄柚,香蕉,葡萄,苹果,梨,菠萝,苦杏仁,肉桂,糖,棉花糖,香草香精,糖基化甜菊糖苷,NSF01,NSF02,NSF03,NSF04,NSF05及其混合物。
另外的食品成分的非限制性实例包括香料,酸化剂,有机和氨基酸,着色剂,填充剂,改性淀粉,树胶,组织形成剂,防腐剂,抗氧化剂,维生素,乳化剂,稳定剂,增稠剂,胶凝剂,咖啡因,茶氨酸,可可碱及其混合物。
应当理解,本文中所示的前述描述和具体实施方案仅是对本发明的最佳模式及其原理的示例,并且本领域技术人员可以在不脱离本发明的精神和范围的情况下容易地进行变型和添加,因此,应理解本发明的保护范围仅由待批附权利要求的范围限定。
Claims (4)
1.用于降低1型和2型糖尿病患者中升高的血糖水平(高血糖症)的液体或固体组合物,包含至少一种甜菊糖苷,
其中该组合物包含0.0000001%-99.9999999%(w/w,以干重计),更优选0.0001%、0.001%、0.01%、0.05%、0.1%、0.2%、0.3%、0.4%、0.5%、0.6%、0.7%、0.8%、0.9%、1%、1.5%、2%、3%、4%、5%、6%、7%、8%、9%、10%、11%、12%、13%、14%、15%、16%、17%、18%、19%、20%、21%、22%、23%、24%、25%、26%、27%、28%、29%、30%、31%、32%、33%、34%、35%、36%、37%、38%、39%、40%、41%、42%、43%、44%、45%、46%、47%、48%、49%、50%、51%、52%、53%、54%、55%、56%、57%、58%、59%、60%、61%、62%、63%、64%、65%、66%、67%、68%、69%、70%、71%、72%、73%、74%、75%、76%、77%、78%、79%、80%、81%、82%、83%、84%、85%、86%、87%、88%、89%、90%、91%、92%、93%、94%、95%、96%、97%、98%、99%、99.9%的甜菊糖苷及其组合。
2.用于降低1型和2型糖尿病患者中升高的血糖水平(高血糖症)的口服可摄取的液体或固体消费品,包含至少一种甜菊糖苷组合物,其中该口服可摄取的液体或固体消费品包含0.0000001%-99.9999999%(w/w,以干重计),更优选0.0001%、0.001%、0.01%、0.05%、0.1%、0.2%、0.3%、0.4%、0.5%、0.6%、0.7%、0.8%、0.9%、1%、1.5%、2%、3%、4%、5%、6%、7%、8%、9%、10%、11%、12%、13%、14%、15%、16%、17%、18%、19%、20%、21%、22%、23%、24%、25%、26%、27%、28%、29%、30%、31%、32%、33%、34%、35%、36%、37%、38%、39%、40%、41%、42%、43%、44%、45%、46%、47%、48%、49%、50%、51%、52%、53%、54%、55%、56%、57%、58%、59%、60%、61%、62%、63%、64%、65%、66%、67%、68%、69%、70%、71%、72%、73%、74%、75%、76%、77%、78%、79%、80%、81%、82%、83%、84%、85%、86%、87%、88%、89%、90%、91%、92%、93%、94%、95%、96%、97%、98%、99%、99.9%的甜菊糖苷及其组合。
3.降低1型和2型糖尿病患者中升高的血糖水平(高血糖症)的方法,通过口服摄取包含至少一种甜菊糖苷的液体或固体组合物来进行,
其中该组合物包含0.0000001%-99.9999999%(w/w,以干重计),更优选0.0001%、0.001%、0.01%、0.05%、0.1%、0.2%、0.3%、0.4%、0.5%、0.6%、0.7%、0.8%、0.9%、1%、1.5%、2%、3%、4%、5%、6%、7%、8%、9%、10%、11%、12%、13%、14%、15%、16%、17%、18%、19%、20%、21%、22%、23%、24%、25%、26%、27%、28%、29%、30%、31%、32%、33%、34%、35%、36%、37%、38%、39%、40%、41%、42%、43%、44%、45%、46%、47%、48%、49%、50%、51%、52%、53%、54%、55%、56%、57%、58%、59%、60%、61%、62%、63%、64%、65%、66%、67%、68%、69%、70%、71%、72%、73%、74%、75%、76%、77%、78%、79%、80%、81%、82%、83%、84%、85%、86%、87%、88%、89%、90%、91%、92%、93%、94%、95%、96%、97%、98%、99%、99.9%的甜菊糖苷及其组合。
4.降低1型和2型糖尿病患者中升高的血糖水平(高血糖症)的方法,通过口服摄取包含至少一种甜菊糖苷组合物的液体或固体消费品来进行,
其中所述液体或固体消费品包含0.0000001%-99.9999999%(w/w,以干重计),更优选0.0001%、0.001%、0.01%、0.05%、0.1%、0.2%、0.3%、0.4%、0.5%、0.6%、0.7%、0.8%、0.9%、1%、1.5%、2%、3%、4%、5%、6%、7%、8%、9%、10%、11%、12%、13%、14%、15%、16%、17%、18%、19%、20%、21%、22%、23%、24%、25%、26%、27%、28%、29%、30%、31%、32%、33%、34%、35%、36%、37%、38%、39%、40%、41%、42%、43%、44%、45%、46%、47%、48%、49%、50%、51%、52%、53%、54%、55%、56%、57%、58%、59%、60%、61%、62%、63%、64%、65%、66%、67%、68%、69%、70%、71%、72%、73%、74%、75%、76%、77%、78%、79%、80%、81%、82%、83%、84%、85%、86%、87%、88%、89%、90%、91%、92%、93%、94%、95%、96%、97%、98%、99%、99.9%甜菊糖苷及其组合。
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