CN102088970B - 用含槲皮素的组合物在制备改善肾功能的药物中的应用 - Google Patents
用含槲皮素的组合物在制备改善肾功能的药物中的应用 Download PDFInfo
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- CN102088970B CN102088970B CN200980126978XA CN200980126978A CN102088970B CN 102088970 B CN102088970 B CN 102088970B CN 200980126978X A CN200980126978X A CN 200980126978XA CN 200980126978 A CN200980126978 A CN 200980126978A CN 102088970 B CN102088970 B CN 102088970B
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- quercetin
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Abstract
本发明涉及改善肾功能的方法，所述方法通过给予有需要的受试者有效量的含有槲皮素、维生素C和维生素B3和任选叶酸的组合物来改善肾功能。
Description
相关申请的交叉引用
本申请要求于2008年7月9日申请的美国专利申请号12/169,869的权益，其公开内容通过引用全部结合到本文中。
背景
已经知道某些天然抗氧化剂例如槲皮素能抑制自由基所致疾病的急慢性期。此外，某些天然抗氧化剂在与生物相关氧物质(例如羟自由基、超氧化物、氧硫(oxysulfur)、二氧化硫和二氧化氮)的反应中具有协同作用。
概述
本发明描述了一种改善肾功能的方法，所述方法通过给予有需要的受试者有效量的含有槲皮素、维生素C和维生素B3的组合物来改善肾功能。槲皮素、维生素C和维生素B3的重量比可以是1∶0.2-2.5∶0.02-1，例如1∶1∶0.04∶0.8。
优选地，用于本发明方法的组合物还含有叶酸。槲皮素、维生素C、维生素B3和叶酸的重量比可以是1∶0.2-2.5∶0.02-1∶0.2-2(mg/mg/mg/mcg)，例如1∶0.5-1∶0.02-0.2∶0.5-1(mg/mg/mg/mcg)或1∶1∶0.04∶0.8(mg/mg/mg/mcg)。单位“mcg”是微克的缩写。
在本发明的方法中，可通过常规医学实践来鉴别需要所述治疗的受试者并每天给予能提供以下成分的组合物的量：500-2000mg槲皮素(例如500mg槲皮素、1000mg槲皮素、1500mg槲皮素或2000mg槲皮素)，和如有必要，500-2000mg维生素C(例如500-1500mg或500-1000mg)、20-60mg维 生素B3(例如20-40mg)和400-800mcg。在一个实例中，每天给予受试者能提供以下成分的组合物的量：500mg槲皮素、500mg维生素C、20mg维生素B3和400mcg叶酸。在另一实例中，每天给予受试者1000mg槲皮素、1000mg维生素C、40mg维生素B3和800mcg叶酸的组合。
用于本发明方法的组合物，无论是干燥形式(例如粉剂或片剂)或是液体形式(例如饮料或糖浆剂)，都可以是膳食补充剂或药物制剂。所述膳食补充剂或药物制剂可以呈片剂、胶囊剂、软质咀嚼剂或凝胶剂的形式。所述组合物也可以是食品。实例包括茶(例如茶饮料和茶包内容物)、软饮料、果汁(例如水果提取物和果汁饮料)、奶、咖啡、果冻、冰淇淋、酸奶、饼干、谷物食品、巧克力和快餐。
所述组合物也可以是含有上述4种成分和药学上可接受的载体的药物组合物，或是含有所述4种成分和各种无活性添加剂(例如赋形剂、甜味剂和人工矫味剂)的软质咀嚼用组合物。
本发明的范围内还包括任何上述组合物在用于改善肾功能和制造用于改善肾功能的药物中的用途。
本发明的一个或多个实施方案的详述在以下描述中给出。根据所述描述和权利要求书，本发明的其它特征、目的和优势将会是显而易见的。
发明详述
本发明是基于以下意外发现：给予人类受试者含有槲皮素、维生素C、维生素B3和叶酸的组合物，导致肾小球滤过率增加和肌酐激酶活性降低，表明肾功能得以改善。
因此，本文所述的是用有效量的含有槲皮素、维生素C、维生素B3和优选叶酸的组合物来改善肾功能的方法。肾功能是指肾脏的排泄和血液净化或滤过功能。这通常是通过测定肾小球滤过率(GFR，即通过肾脏过滤液体的流速)或肌酐清除率 (CCr，即每单位时间清除掉肌酐的血浆体积)来评价的。GFR或CCr的增加表明肾功能得以改善。本文所用的术语“有效量”是指在与一种或多种其它活性剂一起给予有需要的受试者时，给受试者提供疗效所需的每种活性剂的量。正如本领域技术人员所知，有效量因给药途径、赋形剂的使用和与其它活性剂联用的不同而异。
已经知道，在口服给予时，与单用槲皮素相比，槲皮素、维生素B3和维生素C的组合导致血浆中槲皮素浓度明显更高。更具体地讲，槲皮素、维生素B3和维生素C的组合维持血浆槲皮素水平是单用槲皮素或者槲皮素和维生素B3组合的5倍；并且槲皮素、维生素B3和维生素C的组合导致槲皮素的血浆半衰期长度是单用槲皮素的2倍，是槲皮素和维生素B3组合的约1.5倍。参见US 20080015247和US20080032987。
在用于本发明方法的组合物中，槲皮素、维生素C、维生素B3和叶酸的重量比可以是1∶0.2-2.5∶0.02-1∶0.2-2(mg/mg/mg/mcg)或介于其中的任何比例。例如，所述重量比可以是1∶0.5-1∶0.02-0.2∶0.5-1(mg/mg/mg/mcg)，或1∶1∶0.04∶0.8(mg/mg/mg/mcg)。优选地，每天一次或定时给予受试者能提供以下成分的组合物的量：250mg至2000mg(例如500mg至1500mg，或500mg至1000mg)槲皮素，其可以是槲皮素苷元、异槲皮素或其组合。
术语“槲皮素”是指槲皮素苷元、槲皮素衍生物或其混合物。槲皮素衍生物包括但不限于槲皮素-3-O-葡糖苷(也称为异槲皮素)、槲皮素-5-O-葡糖苷、槲皮素-7-O-葡糖苷、槲皮素-9-O-葡糖苷、槲皮素-3-O-芦丁糖苷、槲皮素-3-O-[α-鼠李糖基-(1→2)-α-鼠李糖基-(1→6)]-β-葡糖苷、槲皮素-3-O-半乳糖苷、槲皮素-7-O-半乳糖苷、槲皮素-3-O-鼠李糖苷和槲皮素-7-O-半乳糖苷。消化之后，槲皮素衍生物转化为槲皮素苷元和其 它活性衍生物，例如葡糖醛酸盐/酯(glucoronate)、硫酸盐/酯和甲酸盐/酯，其可吸收到体内。上述槲皮素的量是指槲皮素苷元或其衍生物和通过消化而形成的槲皮素衍生物的任何槲皮素部分的量。可以纯化形式或混合物成分的形式(例如植物提取物)将槲皮素加入到所述组合物中。市售槲皮素的实例包括来自Quercegen Pharma LLC(Newton，MA)和Merck KGaA(巴西)的QU995(含有99.5％槲皮素)和QU985(含有98.5％槲皮素)。
本文所说的“维生素B3”包括维生素B3的各种形式，包括烟酰胺(niacinamide)、烟酸、烟酰胺(nicotinamide)和肌醇烟酸酯。
本文所说的“维生素C”包括维生素C(即L-抗坏血酸、D-抗坏血酸或这两种)及其盐(例如抗坏血酸钠)。
本文所说的“叶酸”包括维生素B9、叶酸盐/酯、蝶酰谷氨酸(pteroylglutamic acid)和它们的衍生物，例如叶酸甲酯。
用于本发明方法的组合物可以呈不同形式。例如，它可以是包含以下成分的软质咀嚼用组合物：槲皮素、烟酰胺、抗坏血酸、抗坏血酸钠、糖、玉米糖浆、蔗糖素(sucralose)、大豆卵磷脂、玉米淀粉、甘油、棕榈油、木糖醇、角叉菜胶、FD&C Yellow#6、FD&C Yellow#5和天然和/或人工矫味剂。一份示例性的这种软质咀嚼用组合物包含250mg槲皮素、250mg维生素C、10mg维生素B3(例如烟酰胺)和200mcg叶酸。在另一实例中，一份这种软质咀嚼用组合物含有125mg槲皮素、125mg维生素C、5mg维生素B3和100mcg叶酸。受试者每天可以服用1-8份(例如4份)这种软质咀嚼用组合物。所服用的量可因例如所治疗疾病或病症以及受试者身体状态的不同而异。
所述组合物可包含槲皮素、维生素C、维生素B3和叶酸作为仅有的活性成分。它也可进一步含有一种或多种其它活性成分，例如异黄酮(例如染料木黄酮或染料木苷)、姜黄素、白 藜芦醇、异槲皮素、毛地黄黄酮、表没食子儿茶素没食子酸酯(EGCG)、CoQ10、二十碳五烯酸(EPA)和二十二碳六烯酸(DHA)。可将这些活性成分以纯化形式或混合物成分的形式(例如动植物提取物)加入到所述组合物中。这些成分的每一种的合适日剂量可因例如所治疗疾病或病症以及受试者身体状态的不同而异。这些成分的一些示例性的日剂量是：20-2,500mg(优选250-1,000mg)姜黄素、10-1,000mg(优选100-500mg)白藜芦醇、10-1,000mg(优选100-250mg)异槲皮素、50-1,000mg(优选100-700mg)EGCG、25-300mg(优选50-100mg)染料木苷/染料木黄酮、10-1,000mg(优选100-200mg)毛地黄黄酮、50-1,000mg(优选70-500mg)EPA和50-1,000mg(优选80-700mg)DHA。此外，必要时，可通过添加例如以下甜味剂使之变甜：山梨醇、麦芽糖醇、氢化葡萄糖糖浆和氢化淀粉水解产物、高果糖玉米糖浆、甘蔗糖、甜菜糖、果胶、甜叶菊(stevia)和蔗糖素。所述组合物也可含有氨基酸、脂肪酸、蛋白质、纤维、矿物质、香味增强剂或着色剂。示例性的氨基酸包括茶氨酸(例如L-茶氨酸)和丙氨酸(例如L-丙氨酸)。示例性的脂肪酸包括omega-3脂肪酸(例如亚麻酸)、omega-6脂肪酸(例如亚油酸)和omega-9脂肪酸(例如油酸)。示例性的蛋白质包括植物蛋白，例如大豆蛋白和鼠尾草籽蛋白。示例性的纤维包括植物纤维，例如大豆纤维和鼠尾草籽纤维。可将这些成分以纯化形式或混合物成分的形式(例如动植物提取物)添加到上述组合物中。
当上述组合物是呈粉状形式时，它可便利地用于制备饮料、糊剂、胶冻剂、胶囊剂或片剂。乳糖和玉米淀粉通常作为稀释剂用于胶囊剂，作为载体用于片剂。润滑剂例如硬脂酸镁通常包含在片剂中。
用于本发明方法的组合物可以是膳食补充剂或药物制剂。作为膳食补充剂，可包含额外的营养物，例如矿物质或氨 基酸。所述组合物也可以是食品。本文所用的术语“食物”广泛地指用于滋养人类和动物、用于维持正常或加速生长、或用于保持耐力或灵敏性的任何种类的液体和固体/半固体物。人类食物的实例包括但不限于含茶饮料、果汁、咖啡、奶、果冻、饼干、谷物食品、巧克力、快餐、草药提取物、乳制品(例如冰淇淋和酸奶)、大豆制品(例如豆腐)和大米制品。
或者，所述组合物可以是含有药学上可接受的载体的药物组合物，所述载体与组合物的活性成分相容，优选能稳定活性成分并且对所治疗的受试者无害。
在本发明的方法中，通过常规给药途径将有效量的所述组合物给予受试者，以改善其肾功能。术语“给予”包括将本发明的组合物以任何合适形式经口服或胃肠外给予受试者，所述合适形式例如食品、饮料、片剂、胶囊剂、混悬剂和溶液剂。术语“胃肠外”是指皮下、皮内、静脉内、肌内、关节内、动脉内、滑膜内、胸骨内、鞘内、病灶内、腹膜内和颅内注射、以及各种不同输注技术。
可通过体外测定，初步筛选上述组合物对治疗上述病症的功效，然后经动物实验和临床试验进行证实。其它合适的分析和生物测定对于本领域技术人员而言是显而易见的。例如，可通过进行药代动力学研究来测定槲皮素的生物利用度并通过血浆-药物浓度时间曲线的曲线下面积来评价。
无需进一步说明，据信本领域技术人员可根据上述描述，最大限度地利用本发明。因此，以下具体的实施方案仅仅是说明性的，而不是以任何方式限制说明书的其余部分。本文所引用的所有出版物都通过引用结合到本文中。
实施例：用含有槲皮素、维生素C、维生素B3和叶酸的软质咀嚼剂增加肾小球滤过率
将501名受试者随机分为3组，即组1(n＝165)、组2 (n＝170)和组3(n＝166)。每天分别口服给予组1、组2和组3的受试者安慰剂、软质咀嚼剂(每次两个咀嚼剂，每天2次，提供500mg槲皮素、500mg维生素C、20mg维生素B3和400mcg叶酸)和软质咀嚼剂(提供1000mg槲皮素、1000mg维生素C、40mg维生素B3和800mcg叶酸)，共12周。在治疗前后检查这些受试者的肾小球滤过率(GFR)。
相对于组1的受试者，组2和组3的受试者的GFR明显增加，表明槲皮素、维生素C、维生素B3。更具体地讲，虽然组1的GFR在治疗后增加到2.61ml/min的水平，组2和组3的GFR在治疗后分别增加到5.34ml/min和5.21ml/min的水平(p＝0.009)。这些结果表明，槲皮素、维生素C、维生素B3和叶酸的组合改善了肾功能。
其它实施方案
本说明书中公开的所有特征可以任何组合来组合。本说明书中公开的每个特征都可被达到同样的、等同的或类似目的的替代特征来替代。因此，除非另有说明，否则所公开的每个特征仅仅是普通系列的等同或类似特征的一个实例。
根据上述描述，本领域技术人员可以容易地确定本发明的基本特征，并且在不偏离其精神和范围的前提下，可以对本发明进行各种变动和修改，使其适应不同用途和条件。因此，其它实施方案也包括在所附权利要求书的范围之内。
Claims (16)
1.一种含有槲皮素、维生素C、维生素B3和叶酸的组合物在制备用于有需要受试者增加肾小球滤过率的药物中的用途，其中所述槲皮素、维生素C、维生素B3和叶酸的重量比为1∶0.5-1∶0.02-0.2∶0.5-1(mg/mg/mg/mcg)。
2.权利要求1的用途，其中所述组合物的有效量是每天提供500mg-2000mg槲皮素的量。
3.权利要求2的用途，其中所述组合物的有效量是每天提供500mg槲皮素的量。
4.权利要求2的用途，其中所述组合物的有效量是每天提供1000mg槲皮素的量。
5.权利要求2的用途，其中所述组合物的有效量是每天提供1500mg槲皮素的量。
6.权利要求2的用途，其中所述组合物的有效量是每天提供2000mg槲皮素的量。
7.权利要求1的用途，其中所述重量比为1∶1∶0.04∶0.8(mg/mg/mg/mcg)。
8.权利要求1的用途，其中所述组合物的有效量是每天能提供以下成分的量：500-2000mg槲皮素、500-2000mg维生素C、20-60mg维生素B3和400-800mcg叶酸。
9.权利要求8的用途，其中所述组合物的有效量是每天能提供以下成分的量：500mg槲皮素、500mg维生素C、20mg维生素B3和400mcg叶酸。
10.权利要求8的用途，其中所述组合物的有效量是能提供以下成分的量：1000mg槲皮素、1000mg维生素C、40mg维生素B3和800mcg叶酸。
11.权利要求1-10中任一项的用途，其中所述组合物是呈干燥形式。
12.权利要求1-10中任一项的用途，其中所述组合物是呈液体形式。
13.权利要求1-10中任一项的用途，其中所述组合物是食品。
14.权利要求13的用途，其中所述食品是茶、果汁、奶、咖啡、软饮料、果冻、冰淇淋、酸奶、谷物食品、巧克力、饼干或快餐。
15.权利要求1-10中任一项的用途，其中所述组合物是膳食补充剂或药物制剂。
16.权利要求15的用途，其中所述组合物是呈片剂、胶囊剂、软质咀嚼剂或凝胶剂的形式。
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2009
- 2009-07-08 WO PCT/US2009/049902 patent/WO2010006026A2/en active Application Filing
- 2009-07-08 AU AU2009268637A patent/AU2009268637A1/en not_active Abandoned
- 2009-07-08 ES ES09795103.2T patent/ES2616049T3/es active Active
- 2009-07-08 CN CN200980126978XA patent/CN102088970B/zh not_active Expired - Fee Related
- 2009-07-08 NZ NZ590762A patent/NZ590762A/xx not_active IP Right Cessation
- 2009-07-08 EP EP09795103.2A patent/EP2310007B1/en not_active Not-in-force
- 2009-07-08 CA CA2730065A patent/CA2730065C/en not_active Expired - Fee Related
-
2014
- 2014-03-25 US US14/224,686 patent/US20140206695A1/en not_active Abandoned
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6821536B2 (en) * | 2002-11-22 | 2004-11-23 | Quercegen Holdings Llc | Antioxidative compositions |
Non-Patent Citations (1)
| Title |
|---|
| 白光辉等.肾功能不全患者血清叶酸含量的检测.《中华肾脏病杂志》.1994,(第1期),37页. * |
Also Published As
| Publication number | Publication date |
|---|---|
| CN102088970A (zh) | 2011-06-08 |
| CA2730065C (en) | 2017-07-04 |
| US20100010005A1 (en) | 2010-01-14 |
| WO2010006026A3 (en) | 2010-04-01 |
| US8680053B2 (en) | 2014-03-25 |
| ES2616049T3 (es) | 2017-06-09 |
| EP2310007A2 (en) | 2011-04-20 |
| EP2310007B1 (en) | 2016-11-16 |
| CA2730065A1 (en) | 2010-01-14 |
| AU2009268637A1 (en) | 2010-01-14 |
| WO2010006026A2 (en) | 2010-01-14 |
| EP2310007A4 (en) | 2014-01-15 |
| NZ590762A (en) | 2012-09-28 |
| US20140206695A1 (en) | 2014-07-24 |
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