CN105816508A - 小黑豆提取物在制备用于预防、改善或治疗视网膜疾病的组合物中的用途 - Google Patents
小黑豆提取物在制备用于预防、改善或治疗视网膜疾病的组合物中的用途 Download PDFInfo
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Abstract
在本说明书中公开小黑豆提取物在制备用于预防、改善或治疗视网膜疾病的组合物中的用途,尤其是公开包含小黑豆提取物的用于预防或治疗视网膜疾病的药学组合物及包含小黑豆提取物的用于预防或改善视网膜疾病的食品组合物。
Description
技术领域
在本说明书中,公开包含小黑豆提取物的用于预防或治疗视网膜疾病的药学组合物及包含小黑豆提取物的用于预防或改善视网膜疾病的食品组合物。
背景技术
视网膜色素变性症(retinitispigmentosa,RP)为因分布于视网膜的感光细胞及视网膜色素上皮细胞的功能障碍而发生的进行性视网膜变性疾病。感光细胞作为对存在于视网膜的光敏感的感觉细胞,用于将光转换成神经刺激。在脊椎动物视网膜的感光细胞有视锥细胞(锥状体)和视杆细胞(杆状体),在视网膜色素变性症中,上述视锥细胞和上述视杆细胞受损,上述视锥细胞是在光线多时活动的感光细胞,上述视杆细胞是在灰暗的光中活动的感光细胞。视杆细胞起到区分明暗以便明辨的作用,视锥细胞起到区分颜色,并通过视神经向大脑传递根据电信号传输的视觉信息的作用。
在视网膜色素变性症初期,主要是视杆细胞受损,导致出现在暗环境下视力减少的夜盲症,且使周边视野缩小,若进一步发展,则最终还使视锥细胞受损,从而难以区分颜色或事物。作为特征性症状,在发病初期,夜间视力差,逐渐丧失周边视野。中心视力的减少在初期几乎没有,但会在发病后半部出现而发展。
视网膜色素变性症的原因至今未明确,虽然也有报告称紫外线或病毒感染等环境因素有可能是其起因,但认为是由基因异常引起的。最近,还有炎症反应是其起因的重要的因素这样的研究结果,但其准确的机制或病因还有很多不清楚的部分,且由于没有有效的治疗法,因而很多患者发展到失明。当前,没有视网膜色素变性症的根本性治疗方法,为了延缓发展和恶化,并减少日常生活中的不便,进行基因治疗、视网膜移植及药物治疗。
现有技术文献
专利文献
专利文献1:韩国登录特许第10-1449469号
发明内容
在一实施方式中,本说明书的目的在于,提供包含从作为豆科植物的小黑豆获取的提取物作为有效成分的用于预防或治疗视网膜疾病的药学组合物。
在另一实施方式中,本说明书的目的在于,提供包含从作为豆科植物的小黑豆获取的提取物作为有效成分的用于预防或改善视网膜疾病的食品组合物。
在一实施方式中,本说明书的目的在于,提供小黑豆提取物在制备用于预防、改善或治疗视网膜疾病的组合物中的用途。
在一实施方式中,在本说明书中公开的技术提供包含小黑豆提取物作为有效成分的用于预防或治疗视网膜疾病的药学组合物。
在再一实施方式中,在本说明书中公开的技术提供包含小黑豆提取物作为有效成分的用于预防或改善视网膜疾病的食品组合物。
在另一实施方式中,在本说明书中公开的技术提供小黑豆提取物在制备用于预防、改善或治疗视网膜疾病的组合物中的用途。
根据示例性的一实例,上述小黑豆提取物可用选自水、C1至C4的低级醇及它们的组合中的一种以上的溶剂来提取。
根据示例性的一实例,上述小黑豆提取物可由有机溶剂提取。
根据示例性的一实例,上述有机溶剂可以为选自碳原子数为1至4的低级醇(例如甲醇、乙醇、丁醇等)、乙烯、丙酮、己烷、醚、氯仿、乙酸乙酯、乙酸丁酯、二氯甲烷(dichloromethane)、N,N-二甲基甲酰胺(DMF)、亚甲基氯、二甲基亚砜(DMSO)、甘油、丁二醇、丙二醇、二丙二醇、二氯甲烷(methylenechloride)、二乙醚及它们的混合物的一种以上。
根据示例性的一实例,以组合物的总重量为基准,可包含0.1至50重量%的上述小黑豆提取物。
根据示例性的一实例,上述小黑豆提取物可抑制视网膜的感光细胞的细胞凋亡。
根据示例性的一实例,上述小黑豆提取物可抑制由视网膜变性而引起的超表达的神经母细胞的表达。
根据示例性的一实例,上述视网膜疾病可以为由视网膜变性引起的视网膜疾病。
根据示例性的一实例,上述视网膜疾病可以为选自视网膜色素变性、黄斑变性、糖尿病性视网膜病变及视网膜脱离中的一种以上。
在一实施方式中,在本说明书中公开的技术具有如下效果:提供包含从作为豆科植物的小黑豆获取的提取物作为有效成分的用于预防或治疗视网膜疾病的药学组合物。
在另一实施方式中,在本说明书中公开的技术具有如下效果:提供包含从作为豆科植物的小黑豆获取的提取物作为有效成分的用于预防或改善视网膜疾病的食品组合物。
附图说明
图1表示利用光学相干断层扫描装置(Opticalcoherencetomography,OCT)来实时拍摄视网膜断层的照片。具体地,针对C57BL/6鼠利用N-甲基-N-亚硝基脲诱导了视网膜变性之后,以口服给药的方式将小黑豆提取物给药1周至4周。其结果确认如下:在诱导视网膜变性的组中,视网膜层的厚度减少,但在以口服给药的方式给药小黑豆提取物的组中,抑制了由视网膜变性导致视网膜层厚度的减少。
图2表示利用蛋白质印迹分析法(Westernblot)确认由N-甲基-N-亚硝基脲诱导的视网膜变性动物模型中的小黑豆提取物的效果的照片。具体地,在诱导视网膜变性之后,以口服给药的方式将小黑豆提取物给药1周至4周。针对诱导了视网膜变性的动物模型,小黑豆提取物呈现抑制视网膜感光细胞的细胞凋亡,并抑制神经母细胞的超表达的效果。
具体实施方式
以下,对本发明进行详细的说明。
在一实施方式中,在本说明书中公开的技术提供包含小黑豆提取物作为有效成分的用于预防或治疗视网膜疾病的药学组合物。
在再一实施方式中,在本说明书中公开的技术提供包含小黑豆提取物作为有效成分的用于预防或改善视网膜疾病的食品组合物。
在另一实施方式中,在本说明书中公开的技术提供用于预防、改善或治疗视网膜疾病的组合物的制备中小黑豆提取物的用途。
在本说明书中,小黑豆作为豆科(Leguminosae)植物也被称为鼠目太、穞豆,作为通常在韩国的各地山野中自生的植物,茎和叶呈褐色。7月份开黄色的花,当在椭圆形的荚中,直径为5~7mm左右的又黑又圆的果实成熟时收获。
古文献“本草纲目”记载“小黑豆性温、味甜及无毒。将色黑、光滑且小的雄豆作为药使用更佳。治疗肾病,降气,抑制风热,促进血液循环,并解毒”。自古以来,利用于神经痛、肾疾病、老年性痴呆的预防。众所周知,小黑豆中,不仅异黄酮(isoflavone)含量高于黄豆,而且对种皮的抗氧化效果优秀的黄豆黄素(glycitein)和花色素(anthocyanin)成分中的矢车菊素-3-葡萄糖苷(cyanidin-3-glucoside)丰富,从而对脑血管及心脏疾病的预防及治疗有效。
根据示例性的一实例,上述小黑豆可以为鹿藿(Rhynchosianulubilis)。小黑豆可不受限制地使用,即,可使用栽培的小黑豆、采集的小黑豆或销售的小黑豆等。
在本说明书中,提取物意味着包含粗提取物和上述粗提取物的分馏物两者。在为分馏出的提取物的情况下,包含使上述粗提取物悬浮于特定溶剂之后,与极性不同的其他溶剂混合并放置来取得的分馏物、利用依次性溶剂分馏上述粗提取物来取得的分馏物。具体地,意味着包含将小黑豆使用选自水、碳原子数为1至4的低级醇(例如甲醇、乙醇、丁醇等)、乙烯、丙酮、己烷、醚、氯仿、乙酸乙酯、乙酸丁酯、二氯甲烷(dichloromethane)、N,N-二甲基甲酰胺(DMF)、亚甲基氯、二甲基亚砜(DMSO)、甘油、丁二醇、丙二醇、二丙二醇、二氯甲烷(methylenechloride)、二乙醚及它们的混合物中的一种以上的溶剂来提取的粗提取物和将该粗提取物分馏而得到的分馏物。此时,分馏物可使用罗列的上述溶剂来分馏。
就制备提取物的方法而言,考虑有效物质的提取程度、保存程度,可适用热水提取法、浸渍提取法、冷浸提取法、回流冷却提取法、超声波提取法、超临界提取法、亚临界提取法、溶剂提取法、高温提取法、高压提取法、利用包含XAD及HP-20的吸附树脂的提取法或利用微生物的发酵或自然发酵代谢等任意方式。提取次数可以为1至5次,优选地,反复3次来提取,但并不局限于此。并且,上述提取之后,还可追加地实施浓缩或冷冻干燥等的方法。
根据示例性的一实例,可以利用基于二氧化碳的减压、基于高温的超临界流体提取法制备小黑豆提取物,通常,超临界流体具有当气体在高温高压条件下达到临界点时所具有的液体及气体的性质,化学上具有与非极性溶剂类似的极性,由这种特性,超临界流体使用于脂溶性物质的提取。通过超临界流体设备的工作,二氧化碳经过压力及温度达到临界点的过程,而成为同时具有液体及气体性质的超临界流体,最终对脂溶性溶质的溶解度增加。若超临界二氧化碳通过含有规定量的试样的提取容器,则试样所含的脂溶性物质被超临界二氧化提取出。若提取脂溶性物质之后,使含有少量的共溶剂的超临界二氧化碳再次流经残留在容器中的试样,则还可提取出仅用纯净的超临界二氧化碳未能提取出的成分,这种共溶剂可使用选自氯仿、甲醇、乙醇、水、乙酸乙酯、己烷及二乙醚的一种或两种以上的混合物。虽然被提取出的试样大部分含有二氧化碳,然而二氧化碳在室温条件下向空气中挥发,此外共溶剂可利用减压蒸发器来去除。
根据示例性的一实例,可利用超声波提取法制备小黑豆提取物,上述超声波提取法利用由超声波振动而产生的能量。超声波在水溶性溶剂中可破坏包含于试样的不溶性物质,由于此时产生的高的局部温度,位于周围的反应物粒子的运动能量变大,因而取得反应所需的充分的能量,并通过超声波能量的冲击效果来诱导高的压力,从而提高包含于试样的物质和溶剂的混合效果,以增加提取效率。
根据示例性的一实例,可经过发酵过程制备小黑豆提取物。将小黑豆微细地破碎成100至500目左右之后,添加1至50g/L的通常的微生物培养液,并以10000至100000cfu/L的量添加酵母菌或乳酸菌等微生物。作为培养温度,在30至37℃这样的通常的微生物培养条件下进行培养,pH设为5至7,在好气性或厌气性条件下,培养约5至10天,之后通过熟化及过滤可取得提取物。
根据示例性的一实例,上述小黑豆提取物的制备方法包括如下步骤,但并不局限于这些。
步骤1),向干燥的小黑豆(鹿藿)添加提取溶剂进行提取;步骤2),对步骤1)的提取物进行过滤;步骤3),对步骤2)的过滤的提取物进行减压浓缩来制备提取物;以及步骤4),还利用有机溶剂提取步骤3)的提取物,来制备分馏物。
在一实施方式中,在上述步骤1)中,提取溶剂可以为选自水、碳原子数为1至4的低级醇及它们的混合物中的一种以上的溶剂,具体地,可以为甲醇或乙醇水溶液。提取溶剂的量优选为添加小黑豆重量的1至20倍,具体地,添加相当于10倍的量,但并不局限于这些。
在另一实施方式中,就上述步骤1)中的提取方法而言,可加温并回流提取,或在常温条件下提取,或超声波提取。提取时,温度可以为10至100℃,具体地,可以为15至25℃的常温,提取时间为1至7天,具体地,可以为3天至7天,但并不局限于这些。
在另一实施方式中,就上述步骤3)中的减压浓缩而言,可利用真空旋转蒸发器。通过进行热风干燥、减压干燥、真空干燥、沸腾干燥、喷雾干燥、常温干燥或冷冻干燥,可制备去除了提取溶剂的浓缩的液状的提取物或固体状的提取物。
在再一实施方式中,上述步骤4)中的有机溶剂,可以为正己烷、亚甲基氯、乙酸乙酯或正丁醇。上述分馏物可以为使小黑豆提取物悬浮于水中之后,利用正己烷、亚甲基氯、乙酸乙酯、正丁醇及水依次进行系统分馏来获取的正己烷分馏物、亚甲基氯分馏物、乙酸乙酯分馏物、正丁醇分馏物和水分馏物中的任一种,更优选为亚甲基氯分馏物,但不局限于这些。可从上述小黑豆提取物反复1至5次分馏过程,具体地,3次分馏过程,从而获取上述分馏物,分馏之后可进行减压浓缩。
根据示例性的一实例,上述小黑豆提取物可包含小黑豆本身、小黑豆的提取液、提取液的稀释液或浓缩液、对提取液进行干燥来取得的干燥物及他们的粗纯化物或纯化物中的任一种以上。
根据示例性的一实例,上述小黑豆提取物以组合物的总重量为基准可包含0.1至50重量%,具体地包含1至30重量%,更具体地包含5至25重量%。
根据示例性的一实例,上述小黑豆提取物可抑制视网膜的感光细胞的细胞凋亡。上述小黑豆提取物保护视网膜的感光细胞,从而对由视网膜神经细胞退化引起的视网膜色素变性症的预防、改善或治疗有效。
根据示例性的一实例,上述小黑豆提取物可抑制由视网膜变性超表达的神经母细胞的表达。
根据示例性的一实例,上述视网膜疾病可以为由视网膜变性引起的视网膜疾病。
根据示例性的一实例,上述视网膜疾病可以为选自视网膜色素变性、黄斑变性、糖尿病性视网膜病变及视网膜脱离中的一种以上。上述黄斑变性可以为老年性黄斑变性。
上述组合物可以为药学组合物或食品组合物。
本发明的组合物还可包含通常用于制备药剂的适当的载体、赋形剂及稀释剂。
本发明的组合物,根据通常的方法能够分别以散剂、颗粒剂、片剂、胶囊剂、悬浮液、乳液、糖浆、气溶胶(aerosol)等口服型剂型、外用剂、栓剂及灭菌注射溶液的形态剂型化来使用。
作为可包含于本发明的组合物的载体、赋形剂及稀释剂,可例举乳糖、葡萄糖、蔗糖、山梨糖醇、甘露醇、木糖醇、赤藓糖醇、麦芽糖醇、淀粉、阿拉伯胶、海藻酸、明胶、磷酸钙、硅酸钙、纤维素、甲基纤维素、微晶纤维素、聚乙烯吡咯烷酮、水、羟基苯甲酸甲酯、羟基苯甲酸丙酯、滑石、硬脂酸镁及矿物油。在进行制剂化的情况下,使用通常使用的填充剂、增量剂、结合剂、润湿剂、崩解剂、表面活性剂等的稀释剂或赋形剂来制备。用于口服给药的固体制剂包含片剂、丸剂、散剂、颗粒剂、胶囊剂等,在本发明的组合物中混合一种以上的赋形剂,例如,淀粉、碳酸钙(calciumcarbonate)、蔗糖(sucrose)或乳糖(lactose)、明胶等来制备这种固体制剂。除了简单的赋形剂之外,还使用硬脂酸镁、滑石等的多种润滑剂。用于口服的液体制剂有悬浮剂、内容液剂、乳剂、糖浆剂等,除了通常使用的作为简单稀释剂的水、液体石蜡之外,可包含多种赋形剂,例如,润湿剂、甜味剂、芳香剂、保藏剂等。用于非口服给药的制剂包含灭菌的水溶液、非水性溶剂、悬浮剂、乳剂、冷冻干燥制剂及栓剂。作为非水性溶剂、悬浮剂,可使用丙二醇(propyleneglycol)、聚乙二醇及橄榄油等的植物性油、油酸乙酯等的可注射的酯等。作为栓剂的基剂,可使用witepsol、聚乙二醇(Macrogol)、吐温(tween)61、可可脂、laurinum、甘油明胶等。
本发明的组合物根据所希望的方法能够以口服给药的方式给药或能够以非口服给药的方式给药(例如,适用于静脉内、皮下、腹腔内或局部),给药量的范围根据患者的状态、体重、年龄、性别、饮食、排泄率、疾病的重症度、药物形态、给药时间、给药方法、给药途径及给药期间等而多样。一天的给药量为,按照对本发明的提取物、分馏物或化合物进行冷冻干燥时的量为0.0001mg/kg至500mg/kg,优选为0.001mg/kg至100mg/kg,根据需要,能够以一天一次或分开几次进行给药。
包含本发明的小黑豆提取物的食品的种类不受特别限制。作为可添加上述物质的食品的例子,有包含清凉剂、肉类、香肠、面包、小点心(biscuit)、糕、巧克力、糖类、快餐类、饼干类、比萨、方便面、其他面类、口香糖类、冰淇淋类的乳制品、各种汤、饮料、酒精饮料及维生素复合剂等,通常意义上的保健食品均包含在内。
本发明的小黑豆提取物、小黑豆提取物的分馏物或由此分离的化合物,可直接添加到食品或与其他食品或食品成分一同使用,按照通常的方法可适当地使用。有效成分的混合量可根据其使用目的(预防或改善用)适当地被确定。通常,在保健食品中,可添加食品总重量的0.1至90重量份的上述提取物。但是,将保健及卫生为目的或保健调节为目的长时间摄取的情况下,上述量可以为上述范围以下,在安全性方面不存在任何问题,因而有效成分还可使用上述范围以上的量。
本发明的保健饮料组合物除了以指示的比率作为必要成分含有上述提取物之外,其他成分没有特别的限制,与通常的饮料一样,可包含多种香味剂或天然碳水化合物等作为追加成分。上述天然碳水化合物例如有作为单糖的葡萄糖、果糖等、作为二糖的麦芽糖、蔗糖等以及作为多糖的糊精、环糊精等通常的糖及木糖醇、山梨糖醇及赤藓糖醇等糖醇。除了上述之外,作为香味剂可有利地使用天然香味剂(索马甜、甜叶菊提取物(例如,莱鲍迪苷A、甘草甜素等))及合成香味剂(糖精、阿斯巴甜等)。通常,本发明的每100ml的组合物中,上述天然碳水化合物的比率为约1至20g、优选为约5至12g。
除了上述之外,本发明的小黑豆提取物、小黑豆提取物的分馏物或由此分离的化合物可包含多种营养剂、维生素、矿物(电解质)、合成风味剂及天然风味剂等风味剂、着色剂及增强剂(奶酪、巧克力等)、果胶酸及其盐、海藻酸及其盐、有机酸、保护性胶体增稠剂、pH调节剂、稳定剂、防腐剂、甘油、乙醇、使用于碳酸饮料的碳酸剂等。除此之外,本发明的小黑豆提取物、小黑豆提取物的分馏物或由此分离的化合物可包含天然果汁及果汁饮料及用于制备蔬菜饮料的果肉。这种成分可独立使用或组合使用。这种添加剂的比率并不特别重要,但是,通常,相对于每100重量份的本发明的小黑豆提取物或小黑豆提取物的分馏物,在0.1至约20重量份的范围内选择。
N-甲基-N-亚硝基脲(MNU,N-methyl-N-nitrosourea)作为在日常环境中广泛扩散存在的氮化合物,是在多种动物中诱发视网膜变性的烷基(alkylating)化合物。已知在小鼠的视网膜变性动物模型中,N-甲基-N-亚硝基脲诱发感光细胞的细胞凋亡(apoptosis),其损伤与容量和时间成正比。由N-甲基-N-亚硝基脲导致视网膜受损之后,为了去除细胞残骸恢复视网膜而发生免疫细胞的浸润及米勒细胞(Mullercell)的增值。并且,作为已知的发癌物质的N-甲基-N-亚硝基脲是在无p-450系统(system)的代谢活化的情况下直接发生烷基化的强突变原。
像这样,已知在多种动物实验中,N-甲基-N-亚硝基脲引起视网膜变性,从而在眼科领域中,将N-甲基-N-亚硝基脲主要利用于研究视网膜色素变性的实验中。N-甲基-N-亚硝基脲对感光细胞呈现毒性,选择性地诱发感光细胞的细胞凋亡而引起视网膜变性,这种N-甲基-N-亚硝基脲的毒性抑制感光细胞核中的DNA加合物(DNAadduct)的形成,由Bax蛋白质的上调(up-regulation)和Bcl-2蛋白质的下调(down-regulation)及胱天蛋白酶家族(caspasefamily)的活化而引起。已知N-甲基-N-亚硝基脲对感光细胞的毒性与时间和容量成正比地增加。
对此,利用N-甲基-N-亚硝基脲来确认了本说明书中公开的小黑豆提取物的视网膜变性的保护效果。
以下,通过实施例对本发明进行更详细的说明。只是,这些实施例仅用于例示本发明,本发明的范围不局限于这些实施例,这对于本发明所属技术领域的普通技术人员来说是显而易见的。
实施例
在3kg的已粉碎的小黑豆(鹿藿)粉末中添加2L的乙醇,具体地,添加浓度为70%的乙醇溶剂,利用超声波提取4小时之后,过滤了提取液。过滤提取液之后,在残留的残渣中重新添加15L的乙醇,具体地添加浓度为70%的乙醇溶剂,利用超声波提取4小时,将这种方法反复两次来获取了45L的总提取液。在35℃温度下,对45L的上述提取液进行减压浓缩来获取了150g的小黑豆乙醇提取物。
实验例
为了确认小黑豆提取物对视网膜变性的功效,将由N-甲基-N-亚硝基脲(MNU,N-Methyl-N-nitrosourea)诱导的白鼠的视网膜退化作为对象进行了如下实验。
具体地,以每组六只的方式将6周龄及18~20g的雄性C57BL/6(中心实验动物,CentralLab.AnimalInc.)小鼠利用于实验中。在由N-甲基-N-亚硝基脲诱导视网膜变性1小时之前,作为预处理步骤,在水中溶解在上述实施例中获取的小黑豆提取物(EERN)来以50mg/Kg的容量进行了口服给药。之后,以50mg/kg的容量单次向腹腔内注射了溶解于0.01M的磷酸盐缓冲液(PBS)的N-甲基-N-亚硝基脲。在对照组(control)中,注入了相同容量的0.01M的磷酸盐缓冲液。另一方面,直到N-甲基-N-亚硝基脲诱导后经过4周为止,每日口服给药了小黑豆提取物,当注入N-甲基-N-亚硝基脲之后经过1周及4周时,处死小鼠。
在由上述N-甲基-N-亚硝基脲诱导的视网膜变性动物模型中,为了实时观察小黑豆提取物的效果,使用了光学相干断层扫描装置(Opticalcoherencetomography,OCT)。在麻醉小鼠之后,在小鼠眼中滴入散瞳剂来扩张虹膜,将麻醉的小鼠固定于架子,并利用光学相干断层扫描装置来拍摄了视网膜断层照片。
其结果,如图1所示,注入N-甲基-N-亚硝基脲1周之后,与对照组(control)相比,视网膜的厚度有所减少。4周之后,观察到在注入N-甲基-N-亚硝基脲的组中,视网膜层的排列变得无秩序,且外层被破损。但是,在给药小黑豆提取物的组中,确认如下:抑制了由N-甲基-N-亚硝基脲诱导的视网膜的厚度减少,并维持视网膜层的排列,具有保护视网膜的效果。即,可知小黑豆提取物具有抑制由视网膜变性减少的视网膜层的厚度和层排列的无秩序的效果。
并且,为了在由上述N-甲基-N-亚硝基脲诱导的视网膜变性动物模型中确认小黑豆提取物的神经母细胞活性及感光细胞活性,将视网膜组织作为对象来执行了蛋白质印迹分析。去死小鼠之后,从组织提取蛋白质,附着与神经母细胞相关的蛋白质(胶质纤维酸性蛋白(GFAP,glialfibrillaryacidicprotein))及与感光细胞相关的蛋白质(视紫红质(Rhodopsin))的抗原来执行了分析。
其结果,如图2所示,注入N-甲基-N-亚硝基脲1周之后,与对照组(control)相比,视网膜的感光细胞的表达减少,且神经母细胞的表达增加。注入N-甲基-N-亚硝基脲4周之后,感光细胞蛋白质的表达完全消失,且神经母细胞的表达急增。但是,当处理小黑豆提取物时,抑制神经母细胞的蛋白质(胶质纤维酸性蛋白(GFAP,glialfibrillaryacidicprotein))的表达,并增加感光细胞的蛋白质(视紫红质(Rhodopsin))的表达。即,可知如下:在本说明书中公开的小黑豆提取物抑制视网膜感光细胞的细胞凋亡,抑制发生视网膜变性时被活化的神经母细胞因子的表达,从而具有对视网膜变性的保护效果。
因此,确认如下:在本说明书中公开的小黑豆提取物保护视网膜,尤其视网膜感光细胞的退化,对与视网膜细胞退化相关的视网膜疾病的预防、改善或治疗具有效果。
以下,对本发明的一实施方式的组合物的制剂例进行说明,但还可作为其他多种制剂应用,这并不限定本发明,只是具体地说明本发明。
制剂例1.滴眼凝胶剂的制备
小黑豆提取物5mg
卡波姆93420mg
适量的三乙醇胺
对羟基苯甲酸甲酯2mg
灭菌纯净水ad.1g
在灭菌纯净水中添加对羟基苯甲酸甲酯进行加热来溶解之后冷却,并溶解了小黑豆提取物。其中,添加934mg的卡波姆,并利用高速搅拌器来混合并分散之后,进行放置来去除了空气。其中,一边以每次一滴的方式添加三乙醇胺一边以防止空气进入的方式小心翼翼地进行搅拌来制备。
制剂例2.滴眼液剂的制备
小黑豆提取物5g
苯扎氯铵0.1g
氯化钠5g
硼酸6.2g
四丁酚醛1.0g
适量的稀盐酸
灭菌纯净水1000ml
在小黑豆提取物中依次投入氯化钠、硼酸来溶解,并在其中添加溶解于少量的灭菌纯净水的苯扎氯铵、四丁酚醛来进行了搅拌。添加稀盐酸来调节了pH。使用0.45微型过滤器来实施了灭菌。
制剂例3.滴眼软膏剂的制备
小黑豆提取物5mg
灭菌纯净水10mg
对羟基苯甲酸甲酯2mg
无水羊毛脂100mg
白凡士林1g
在灭菌的玻璃质碗中放入羊膜提取物和对羟基苯甲酸甲酯,并添加小黑豆提取物进行溶解之后,在其中添加无水羊毛脂并混合直到均质为止,由此制备。
制剂例4.软质胶囊剂
混合330mg的小黑豆提取物、50mg的红参提取物、2mg的棕榈油、8mg的氢化棕榈油、4mg的黄蜡及6mg的卵磷脂,并根据通常的方法以每个胶囊400mg的方式进行填充来制备了软质胶囊。
制剂例5.片剂
混合150mg的小黑豆提取物、100mg的葡萄糖、50mg的红参提取物、96mg的淀粉及4mg的硬脂酸镁,并添加40mg的30%乙醇来形成颗粒之后,在60℃温度下进行干燥,利用压片机来压片成片剂。
制剂例6.颗粒剂
混合150mg的小黑豆提取物、100mg的葡萄糖、50mg的红参提取物、600mg的淀粉,并添加100mg的30%乙醇来形成颗粒之后,在60℃温度下进行干燥来形成颗粒之后填充于袋中。内容物的最终重量为1g。
制剂例7.清凉剂
混合150mg的小黑豆提取物、10g的葡萄糖、50mg的红参提取物、2g的柠檬酸及187.8g的纯净水并填充于瓶中。内容物的最终容量为200ml。
制剂例8.保健食品的制备
小黑豆提取物................1000mg
维生素混合物
维生素A醋酸...............70μg
维生素E........................1.0mg
维生素B1......................0.13mg
维生素B2......................0.15mg
维生素B6.....................0.5mg
维生素B12...................0.2μg
维生素C......................10mg
生物素.........................10μg
烟酰胺.........................1.7mg
叶酸.............................50μg
泛酸钙.........................0.5mg
无机质混合物
硫酸亚铁....................1.75mg
氧化锌........................0.82mg
碳酸镁........................25.3mg
磷酸二氢钾.................15mg
磷酸氢钙....................55mg
柠檬酸钾...................90mg
碳酸钙......................100mg
氯化镁......................24.8mg
上述维生素及矿物混合物的组成比将比较适合保健食品的成分混合构成为优选实施例,但也可任意变形其配合比来实施,根据通常的保健食品的制备方法混合上述的成分之后,制备颗粒,并根据通常的方法可使用于保健食品组合物的制备。
制剂例9.保健饮料的制备
小黑豆提取物.........1000mg
柠檬酸.....................1000mg
低聚糖.....................100g
梅子浓缩液.............2g
牛黄酸.....................1g
添加纯净水而成的总量....900ml
根据通常的保健饮料的制备方法混合上述的成分之后,在85℃温度下,搅拌并加热约1小时之后,过滤被制成的溶液来在已灭菌的2l的容器中取得,密封灭菌之后进行冷藏保管,来使用于本发明的保健饮料组合物的制备中。
上述组成比将比较适合的成分混合构成为优选的实施例,但也可根据需要阶层、需要国家、使用用途等地区性、民族喜好度任意变形其配合比率来实施。只要是本发明所属技术领域的普通技术人员,则能够以上述内容为基础在本发明的范畴内实现多种应用及变形。
以上,对本发明内容的特定部分进行了详细说明,就本发明所属技术领域的普通技术人员来说,这种详细技术只属于优选实施方式,本发明的范围不局限于此,这是显而易见的。因此,本发明的实质性的范围应根据所附的权利要求保护范围和其的等同技术方案来定义。
Claims (8)
1.一种小黑豆提取物在制备用于预防、改善或治疗视网膜疾病的组合物中的用途。
2.根据权利要求1所述的用途,其中,
上述小黑豆提取物是用选自水、C1至C4的低级醇及它们的组合中的一种以上的溶剂提取的。
3.根据权利要求1所述的用途,其中,
以组合物的总重量为基准,包含0.1至50重量%的上述小黑豆提取物。
4.根据权利要求1所述的用途,其中,
上述小黑豆提取物抑制视网膜的感光细胞的细胞凋亡。
5.根据权利要求1所述的用途,其中,
上述小黑豆提取物抑制由视网膜变性而引起的超表达的神经母细胞的表达。
6.根据权利要求1所述的用途,其中,
上述视网膜疾病为由视网膜变性引起的视网膜疾病。
7.根据权利要求1所述的用途,其中,
上述视网膜疾病为选自视网膜色素变性、黄斑变性、糖尿病性视网膜病变及视网膜脱离中的一种以上。
8.根据权利要求1所述的用途,其中,
上述组合物为药学组合物或食品组合物。
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CN102036675A (zh) * | 2008-02-25 | 2011-04-27 | 吴荣灿 | 黑豆用于治疗眼疾的用途 |
CN102905714A (zh) * | 2010-03-31 | 2013-01-30 | 株式会社爱茉莉太平洋 | 含有香豆雌酚或包含香豆雌酚的豆提取物的组合物 |
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CN101115476A (zh) * | 2005-02-11 | 2008-01-30 | 帝斯曼知识产权资产管理有限公司 | 玉米黄质用于治疗周边视网膜疾病的用途 |
CN102036675A (zh) * | 2008-02-25 | 2011-04-27 | 吴荣灿 | 黑豆用于治疗眼疾的用途 |
CN102905714A (zh) * | 2010-03-31 | 2013-01-30 | 株式会社爱茉莉太平洋 | 含有香豆雌酚或包含香豆雌酚的豆提取物的组合物 |
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