CN1245984C - 用于预防和/或治疗血管疾病的制剂 - Google Patents
用于预防和/或治疗血管疾病的制剂 Download PDFInfo
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- CN1245984C CN1245984C CNB018124615A CN01812461A CN1245984C CN 1245984 C CN1245984 C CN 1245984C CN B018124615 A CNB018124615 A CN B018124615A CN 01812461 A CN01812461 A CN 01812461A CN 1245984 C CN1245984 C CN 1245984C
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- acid
- vitamin
- phospholipid
- zinc
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Abstract
本发明涉及适于预防和/或治疗血管疾病的制剂,所述制剂包括以下部分:a)部分,长链多不饱和脂肪酸;b)部分,磷脂,这部分含有至少两种不同的磷脂,所述磷脂选自磷脂酰丝氨酸、磷脂酰肌醇、磷脂酰胆碱和磷脂酰乙醇胺;c)部分,化合物,所述化合物是甲硫氨酸代谢中的因子,这部分含有选自叶酸、维生素B12、维生素B6、镁和锌中的至少一员。
Description
背景技术
本发明涉及适于预防和/或治疗血管疾病的制剂。本发明还涉及这些制剂用于预防和/或治疗主要原因是血管问题的疾病,尤其是痴呆综合征的用途。
人体中的血管系统在本领域中已经得到了很好的描述。该系统的重要部分是血管,它们通常被分为动脉和静脉,这取决于它们是将血液传输到心脏还是从心脏传输出。它们大小不同,从大(例如主动脉)到小(例如毛细管)都有。从解剖学观点来看,从腔侧观察,较大的血管通常包括:
1.内膜,它由内皮细胞的光滑(单)层和内皮下层组成,所述内皮下层由结缔组织的疏松层组成,
2.中膜,它由(受神经支配的)平滑肌细胞层和弹性纤维组成,
3.外膜,它由松散交织的胶原纤维组成,所述胶原纤维被细微的淋巴管和血管浸润。
内膜中的内皮细胞直接和血液接触,它对下层组织具有屏障功能。该屏障功能包括从血液向下层组织选择性转运成分以及从下层组织向血液转运成分,以及保护下层组织。由于多种原因如机械力或与应激原成分如典型的过敏毒素,和可能在血液中出现的成分如高半胱氨酸,或来自用某种类型的药物(例如化学治疗剂)的治疗的成分相互作用,所以内皮细胞易于受到损伤。血管通透性可以通过多种体液和细胞衍生的传递质得到进一步提高。
内皮功能障碍可能导致多种疾病。对内皮层的损伤可能扰乱其生理功能如转运性质,并使下层组织暴露于应激原。单核细胞可能迁移到这些损伤的位点,并被粘着分子捕获,分化成巨噬细胞,当被激活时,巨噬细胞可以启动炎症反应。由于该反应,细胞因子可以得到释放,这可以引发反应性氧物种的释放,或者改变血液成分的凝固行为。这可能导致动脉中斑块的出现,斑块的出现可能最终引起高血压、动脉粥样硬化和(后来的)动脉硬化。
动脉粥样硬化可能导致对组织的供血受损,然后这可能变成缺血。这可能导致细胞损伤甚至是依赖于经这些血管供应氧和营养物的细胞的调亡。缺血的组织因此可能失去功能。
痴呆综合征的特征在于脑功能的异常高和进行性丧失。该过程可能在生命的相对早期开始,象与一些形式的癫痫、脑炎、亨廷顿舞蹈病有关的痴呆,在(慢性)酒精中毒或药物滥用后可以观察到的痴呆,以及由于脑血管意外的痴呆和一些遗传形式的痴呆(早发性痴呆)。其也可以在生命的相对晚期开始,如阿尔茨海默病(早老性痴呆)、老年痴呆和动脉粥样硬化痴呆。痴呆可能突然发生,例如在中风事件后,或非常缓慢地发生如老年痴呆。
阿尔茨海默病的特征在于淀粉样-β肽(AB)从存在于神经元的内体或中枢神经系统的其他细胞中的前体蛋白(APP)切除的早期步骤。由β分泌酶(BACE)产生的AB肽可以在细胞外扩散并聚合成淀粉样丝,所述淀粉样丝然后可能发展为成熟淀粉样斑,尤其是当伴侣分子如蛋白酶抑制剂存在时。对AB聚合物沉积和/或淀粉样斑的炎症反应最后可能导致神经元细胞死亡和脑功能丧失。
痴呆综合征发生相对频繁,在荷兰约10%的老龄人群患有这种疾病,而且仍未找到预防或治疗痴呆的治疗方法。用提高神经递质如乙酰胆碱、5-羟色胺或(去甲)肾上腺素的脑水平的药物长期治疗是无效的,并且经常给予的相对高的剂量可能导致不期望的副作用。
对于预防和治疗血管疾病而言,也没有合适的治疗方法。血管疾病及其后果在西方国家是主要的死亡原因。目前,通过限制胆固醇、饱和脂肪酸,以及在一些情况下限制钠含量的特定饮食和给予设计用以降低血压(例如利尿药)和血浆胆固醇水平的药物如抑制素(或能够抑制HMG-CoA还原酶活性的其他化合物)治疗血管疾病。
虽然一些治疗在治疗与血管问题相关的部分现象方面确实有效,但是在解决真正问题(原因)方面这些治疗并不是100%有效,它们可能表现出不期望的全身副作用。
现有技术
血管内皮细胞和它们在血管中的功能已经得到了长时间的研究。有关这些细胞中发生的生化过程的许多细节也已发表。
最近,Chang发表了关于吡哆醛-5-磷酸对人脐静脉内皮细胞的作用的体外数据,该数据“提示维生素B6通过加强有益功能并预防引起动脉粥样硬化开始和疾病发展的细胞损伤来保护内皮细胞”。参见Chang S.J.Nutrition Research,1999,19(11),1613-1624;“VitaminB6 protects vascular endothelial injury by activated platelets(维生素B6通过活化的血小板保护血管内皮损伤”。
许多文献已经发表了血管疾病和痴呆综合征的病因学。已经在食用水果对高半胱氨酸或胆固醇的血浆水平的影响和心血管疾病的出现之间建立了联系。
细胞膜的结构已经得到了研究;许多不同的成分似乎是膜的一部分,如脂质、蛋白质和胆固醇。胆固醇似乎对细胞膜很重要。它降低外部细胞膜的流动性。它还能够捕获一些自由基并且被声称停止在细胞膜中的自增长自由基链反应。现在认为应该用低胆固醇饮食治疗血管疾病。然而,没有认识到一些形式的胆固醇,尤其是血浆胆固醇在与血管损伤相关的修复机理中可能是重要的。
WO 99/11625公开了石衫碱甲的特定衍生物在治疗阿尔茨海默痴呆和重症肌无力中用于抑制乙酰胆碱酯酶的用途。
EP 0213724公开了磷脂酰胆碱和磷脂酰乙醇胺用于膜流体化的用途。
柠檬酸和/或柠檬酸盐在食品生产中广泛用作调味剂、酸化剂和产品稳定剂。US 5,234,702和5,077,069公开了柠檬酸作为棕榈酸抗坏血酸酯、β-胡萝卜素和生育酚的抗氧化作用的协同成分。
WO 99/21565公开了选自柠檬酸、乌头酸、异柠檬酸、α-酮戊二酸、琥珀酸、延胡索酸、苹果酸和草酰乙酸或它们的前体的任何三羧酸循环中间体用于治疗特征在于氧化代谢水平下降的疾病的用途(第5页,第25行),尤其是治疗神经系统的疾病,但也治疗心血管疾病。特别是草酰乙酸盐的前体是优选的(第7页,第10行)。没有文献显示给予这些成分对血管内皮细胞具有有益作用,也没有文献显示通过在组合物中包含磷脂或LC-PUFA's可以获得附加作用。
EP 0 711 559描述了磷脂酰丝氨酸用于生产改善脑活动,尤其是用于治疗帕金森病和痴呆如阿尔茨海默痴呆的药物的用途。根据本文的制剂含有磷脂酰-L-丝氨酸作为有效成分,磷脂酰-L-丝氨酸具有衍生自至少一种原料卵磷脂的结构脂肪酸链。PCT/US88/01693描述了磷酸乙醇胺和相关化合物用于治疗阿尔茨海默痴呆的用途。
发明内容
现在本发明者已经发现了一种用于治疗血管疾病的制剂,所述制剂有效,因为它提供对内膜和内皮细胞的功能的普遍活性,这对影响多种血管疾病和几种其他继发疾病,尤其是痴呆综合征的病因和发展很重要。
因此,本发明提供一种适于预防和/或治疗血管疾病的制剂,所述制剂包含以下部分:
a)长链多不饱和脂肪酸;
b)磷脂,该部分含有磷脂酰丝氨酸和至少一种选自磷脂酰肌醇、磷脂酰胆碱和磷脂酰乙醇胺的磷脂;
c)化合物,所述化合物是甲硫氨酸代谢中的因子,该部分含有选自叶酸、维生素B12、维生素B6、镁和锌中的至少一员。
本发明的制剂可以是药物、饮食以及营养制剂。产品形式可以是液体、粉末、块(bar)、曲奇、糖果、浓缩物、糊剂、沙司、凝胶剂、乳剂、片剂、胶囊剂等,从而以单剂或多剂来提供生物活性成分的每日剂量。可以通过应用本领域已知的方法包装产品,从而在保存期内使产品保持新鲜并易于使用或给药。
具体实施方式
这些部分的联合给药导致在不同水平上治疗和预防血管疾病,尤其是在内膜和内皮细胞的水平上的普遍治疗和预防。a)部分含有长链多不饱和脂肪酸,优选Ω-3和/或Ω-6脂肪酸。脂肪酸可以是游离脂肪酸,但优选是连接到适宜的主链上,例如甘油三酯。它们也可以是磷脂的形式,如下文所述。
a)部分的功能是调节可能发生在血管壁和脑组织中的炎症过程,使血浆胆固醇水平,特别是LDL-胆固醇水平正常化,以及逆转动脉粥样硬化过程,和增加神经元、红细胞和血管膜的流动性。发现尤其是应该包含Ω-3和Ω-6长链多不饱和脂肪酸(LCPUFA′s)的混合物,其中Ω-3脂肪酸对Ω-6脂肪酸的重量比为约2.5至5.5。优选的Ω-3LCPUFA′s为二十碳五烯酸(EPA)和二十二碳六烯酸(DHA)。当含有的DHA和EPA约为等摩尔的量,例如DHA对EPA的重量比为0.5至2时获得最好的结果。优选的Ω-6LCPUFA′s为二高γ亚麻酸(dihomogammalinolenic acid,DHGLA)和花生四烯酸(AA)。这些物质的含量应该约为EPA和DHA的量的四分之一,例如[DHA+EPA]对[DHGLA+AA]的重量比为2.5至5.5,优选为3.3至4.7。EPA+DHA+DHGLA+AA的总每日剂量优选为至少120mg,更优选为至少350mg。特别地,每日剂量的制剂含有20~2000mg,优选50~1000mg EPA,50~2000mg,优选200~1000mg DHA和50~2000mg,优选100~1000mg DHGLA。
可以存在的其他LCPUFA′s为亚油酸和(-亚油酸。然而,EPA+DHA+DHGLA+AA的总量对亚油酸和(-亚油酸的总量的重量比应该大于0.1,优选大于0.2,最优选大于0.4。
如上描述,b)部分含有至少两种不同的磷脂,所述磷脂选自磷脂酰丝氨酸、磷脂酰肌醇、磷脂酰胆碱和磷脂酰乙醇胺。该部分优选含有磷脂酰胆碱、磷脂酰乙醇胺和磷脂酰丝氨酸。
该部分的功能是提供神经元和内皮细胞磷脂的直接来源。它高度优选含有磷脂混合物,尤其是一方面的胆碱/乙醇胺部分对,另一方面的丝氨酸/肌醇部分对。为了获得最好的结果,(磷脂酰胆碱和/或磷脂酰乙醇胺)对(磷脂酰丝氨酸和/或磷脂酰肌醇)的重量比为0.5至20。应给予每日剂量为,至少0.2g,优选超过1g磷脂,例如4g。当产品要给痴呆综合征患者使用时,每日剂量产品的磷脂酰丝氨酸的量应该为至少0.1g,优选大于0.5g。
优选的磷脂的另一个优选的特征是LCPUFA部分。优选使用为a)部分提供上述LCPUFA′s的磷脂。例如它们可以通过应用本领域已知的酯交换方法,使用富含特定LCPUFA′s的原料磷脂混合物和成分来制备。这些特定磷脂的使用确保接近相对稳定的产品的高活性。在口服使用的制剂中,不需要使用高度有机化的脂质部分如鞘磷脂,因为这种类型的化合物在肠、肠上皮细胞和肝中具有高代谢速率。还有,磷脂部分中优选不含基本上无DHA、EPA、DHGLA或AA的其他脂质,如中性甘油三酯,或它们的含量相对低,如小于脂质部分的40%,尤其小于5%。磷脂可以来自蛋黄或大豆,并且可以通过应用本领域已知的方法例如丙酮萃取,及任选地应用后续色谱技术或吸附方法得到分离。如果需要,磷脂部分还可以由合成磷脂和天然磷脂的(提取物)的混合物组成。
c)部分含有化合物,所述化合物是甲硫氨酸代谢中的因子。总甲硫氨酸代谢(TMM)已经在EP 0 891 719中得到描述。虽然已知许多重要化合物如S-腺苷甲硫氨酸(对肌氨酸、肉碱等)和谷胱甘肽的内源生物合成要求TMM正确地发挥功能,尽管有人已经发现血管疾病发生和高同型半胱氨酸血症(hyperhomocysteinaemia)间的关系,但是仍没有认识到总甲硫氨酸代谢的适当功能对尤其是内皮细胞的相关性。
c)部分由化合物组成,所述化合物是甲硫氨酸代谢中的因子,它由选自叶酸、维生素B12、维生素B6、镁和锌中的至少一员组成。该部分优选由叶酸组成,特别是每日剂量为至少200μg,最优选大于400μg的量。叶酸还包括其生理等价物如其药学可接受的盐、5-甲基四氢叶酸和天然存在的其多聚谷氨酸形式。最优选至少包含叶酸和维生素B6,然而如果同时包含这些成分,最大部分的人群将会受益。每日剂量的维生素B6的含量应该大于2mg,特别是大于2.5mg。当该部分含有上述化合物组的所有成员时,甚至更有利。该部分可以进一步含有SAMe(S-腺苷甲硫氨酸)、胆碱、甜菜碱和/或铜。如果c)部分包含锌和铜,锌对铜的重量比在5至12之间。可以包含胆碱和/或甜菜碱。
除了上述a)部分至c)部分之外,根据本发明的制剂可以进一步含有d)部分,d)部分含有柠檬酸盐。柠檬酸盐也包括柠檬酸。根据本发明的产品的pH应该在3.0至7.5之间,优选在5至7之间。每日剂量应该给予的柠檬酸盐的量为0.5至30g,优选为1.5至10g,例如大于2.4g。
在生化文献中,可以发现柠檬酸和一些其他化合物给细胞溶胶提供还原当量并参与“三羧酸循环”,由此在线粒体中产生NADH和能量。还早就知道柠檬酸通过果糖磷酸激酶反应的反馈抑制来帮助调节糖酵解。
然而,尚未认识到为了血管内皮细胞正确地发挥功能,在这些细胞的细胞溶胶中同时具有足量的ATP和NADPH形式的还原当量很重要,以及与功能类似物如三羧酸循环中间体如草酰乙酸、苹果酸或延胡索酸相比,柠檬酸可以更有效地确保其发生。
尤其是在涉及用于预防和治疗痴呆综合征,特别是其中乙酰胆碱代谢严重受损的疾病阶段的产品中,包含石衫碱甲或其功能类似物(e部分)是有利的。每日剂量所包含的石衫碱甲的量应该为0.04至2,优选为0.07至1,最优选为0.08至0.5mg。作为类似物,当石衫碱甲含量和纯度得到标准化时,也可以使用某些草药如蛇足石衫(Huperzia serrata)的提取物。所使用的这种提取物的每日剂量的量可以是0.04~20mg,优选为0.07~2mg。也可以使用石衫碱甲的亲脂性衍生物,例如通过修饰伯氨基和/或仲氨基而获得的衍生物。
根据本发明,含有上述a)部分、b)部分和c)部分以及石衫碱和/或柠檬酸盐的制剂是高度优选的,因为与包含a、b和c部分而不含石衫碱和/或柠檬酸盐的产品相比,它们在一些患者中具有未预期的高活性。
该制剂优选进一步含有f)部分,肉碱、维生素B1、维生素B5和辅酶Q10或它们的功能类似物中的一种或多种。作为肉碱的功能等价物,可以提到其药学可接受的盐或尤其有用的烷酰基和酰基肉碱[乙酰基-L-肉碱],或它们的混合物。肉碱有利地包含在用于痴呆综合征患者的产品中。在这些产品中,亲脂性衍生物优选用作肉碱源。最优选使用乙酰基-L-肉碱。该成分在脑中提供用于生物合成目的的乙酰基。每日剂量的肉碱的量应该为0.1~3g,优选为0.2~1g。可以包含维生素B5,其可以是例如泛酸钙或其他稳定形式。每日剂量产品的优选剂量为8~80mg,更优选为12~40mg。
对于用来治疗或预防痴呆综合征进一步恶化的产品,优选使用亲脂性硫胺素源如苯磷硫胺(benfothiamine)、大蒜硫胺素(allithiamine)、呋喃硫胺(fursulthiamine)或辛硫胺(octothiamine)。在帕金森病和亨廷顿舞蹈病中观察到的脑功能退化可以通过本发明的产品得以延迟。在用于这些类型的患者的产品中,分别包含牛磺酸和γ-氨基丁酸或它们的衍生物如吡乙酰胺是有利的。如果包含辅酶Q10,其量可以是0.8~200mg,优选是5~70mg。由于磷脂对膜功能的有益作用,因此其量可以那么低。
也可以存在提供抗氧化性质的g)部分。g)部分含有选自维生素C、维生素E、硫辛酸、硒盐和类胡萝卜素的抗氧化剂。h)部分含有银杏提取物。该提取物得自叶,其富含黄酮类化合物,尤其是萜类,特别是银杏苦内酯。据显示,例如包含至少4%的银杏苦内酯的提取物有效。
制剂优选含有不同部分的以上成分,其量大于推荐的每日摄入量。本发明的制剂的每日剂量优选包含:
至少120mg长链多不饱和脂肪酸;
至少200mg磷脂;
至少200μg叶酸;以及
至少0.5g柠檬酸。
更优选地,该制剂每日剂量包含:
至少20mg,优选至少50mg二十碳五烯酸;
至少50mg,优选至少200mg二十二碳六烯酸;
至少50mg,优选至少100mg花生四烯酸;
至少200mg,优选至少1000mg磷脂酰丝氨酸;
至少200μg,优选至少400μg叶酸;
至少100mg,优选至少200mg镁;
至少5mg,优选至少10mg锌;
至少2mg,优选至少2.5mg维生素B6;
至少2μg,优选至少4μg维生素B12;
至少1.0g,优选至少1.5g柠檬酸盐。
根据本发明的制剂可以用于治疗和/或预防血管、心脏和脑血管疾病以及选择范围的继发问题。后者的本质和影响取决于时间模式和血流下降的程度和相关器官/组织的功能。内皮细胞的损伤也可能导致弹性丧失,甚至血管的局部损伤。
心血管系统的问题的实例为动脉粥样硬化、心绞痛、心肌梗死、脑血管意外、血栓、M.Bürger、脉管曲张、血栓性静脉炎和雷诺综合征。内皮细胞的损伤还可能导致局部血管收缩。当内皮细胞的损伤具有更系统性的性质时,这可能导致血压升高。可以用该产品治疗的其他血管疾病为动脉粥样硬化、动脉硬化、高胆固醇血症、高脂血症、高血压、心绞痛、脑血管意外、与缺血有关的暂时疾病、静脉血栓形成、产后血栓形成、心肌梗死、静脉曲张(血管曲张)、血栓闭塞性脉管炎和闭塞性动脉硬化。
可以用该产品治疗的继发问题为发生在机械损伤后的一些问题,如发生在事故中、劳动期间或劳动后和外科手术期间的问题。可治疗的继发问题的其他实例为听力丧失问题(尤其是与化疗或衰老有关的)、肝、胃、肾、腿、肺或前列腺功能不正常问题,以及脑功能的突然(脑血管意外)或慢性降低。特别优选的用途是预防具有阿尔茨海默病或血管性痴呆危险的患者的认知退化。
我们相信许多痴呆综合征的基本病因在于心血管疾病。有效的血液供应将给脑提供足量的营养物,这支持对AB肽聚合物沉积的抗炎反应,并且帮助降解斑块。合适的血液供应可以进一步帮助预防在许多神经疾病如帕金森病中(在黑质中)观察到的退化氧化过程,并且支持神经递质如γ-氨基丁酸和多巴胺的生物合成和代谢。
实施例1
痴呆患者一日三次使用的胶囊
用本领域已知的方法制备胶囊,所述胶囊含有以下物质作为活性成分:
DHA 50mg
EPA 75mg
磷脂* 250mg
叶酸 200μg
维生素B12 25mg
蛇足石衫 100μg
维生素B1 100mg
辅酶Q10 10mg
维生素E 200mg
银杏 120mg
*磷脂酰胆碱130mg,磷脂酰丝氨酸120mg(合成的)
实施例2
用于改善血管症状和继发疾病如痴呆综合征的布丁。该布丁基于牛奶、淀粉、糖和调味品由本领域已知的方法制备,每份200ml包括以下物质作为活性成分:
来自蛋的磷脂 4g
(提供约20mg DHA和20mg AA,磷脂含有约77%磷脂酰
胆碱和16%磷脂酰乙醇胺)
磷脂酰丝氨酸 100mg
包入胶囊的鱼油 0.3g
(提供约30mg DHA和30mg EPA)
单细胞油(25mg AA) 0.06g
叶酸(合成的谷氨酸单酯) 0.3mg
维生素B6(吡哆醇) 3mg
锌(硫酸锌) 10mg
镁(氧化镁) 100mg
维生素B12(氰钴胺素) 3μg
柠檬酸盐/柠檬酸 1.2g
盐酸硫胺素 2mg
维生素E 20mg
锰(氧化锰) 10mg
实施例3
粉末浓缩物由实施例2中给出的活性成分和进一步的0.1g橙调味品以及麦芽糖糊精组成,总重量为10g。将该量包装在小袋中,可以在任何饮料(乳、果汁等)中重构。
实施例4
用于改善血管内皮功能的粉末,所述粉末由以下成分组成:
大豆卵磷脂* 3g
叶酸 400μg
维生素B6 3mg
维生素B12 4μg
锌 15mg
镁 150mg
柠檬酸/柠檬酸盐(产品pH为7.0) 2.2g
麦芽糖糊精 使总重量为10g
*磷脂酰胆碱∶磷脂酰乙醇胺∶磷脂酰肌醇=24∶22∶15
实施例5
基于糖、谷物和干水果片的约25g的牛奶什锦早餐块,其包含以下物质作为活性成分:
大豆卵磷脂* 2g
包入胶囊的鱼油 0.6g
SCO(AA) 0.3g
叶酸 400μg
吡哆醇 3mg
氰钴胺素 5μg
氧化锌 30mg
氧化镁 200mg
柠檬酸/柠檬酸盐pH 6.5混合物 2g
蛇足石衫提取物 150μg
银杏提取物 200mg
硫酸钙 300mg
维生素D 10μg
*磷脂酰胆碱∶磷脂酰乙醇胺∶磷脂酰肌醇=45∶26∶14
该块用巧克力层涂层。
Claims (19)
1.适于治疗和/或预防血管疾病的制剂,所述制剂包含以下部分:
a)长链多不饱和脂肪酸;
b)磷脂,该部分含有磷脂酰丝氨酸和至少一种选自磷脂酰肌醇、磷脂酰胆碱和磷脂酰乙醇胺的磷脂;
c)化合物,所述化合物是甲硫氨酸代谢中的因子,该部分含有选自叶酸、维生素B12、维生素B6、镁和锌中的至少一员。
2.根据权利要求1的制剂,所述制剂进一步包含d)部分,柠檬酸盐或柠檬酸。
3.根据权利要求1或2的制剂,所述制剂进一步包含e)部分,石衫碱甲。
4.根据权利要求1或2的制剂,其中a)部分包含Ω-3和Ω-6脂肪酸。
5.根据权利要求4的制剂,其中Ω-3脂肪酸选自二十碳五烯酸和二十二碳六烯酸,且Ω-6脂肪酸选自花生四烯酸和二高γ亚麻酸。
6.根据权利要求1或2的制剂,其中b)部分包含磷脂酰胆碱、磷脂酰乙醇胺和磷脂酰丝氨酸。
7.根据权利要求1或2的制剂,其中c)部分至少含有叶酸和维生素B6。
8.根据权利要求1或2的制剂,其中c)部分进一步含有SAMe、胆碱、甜菜碱和/或铜。
9.根据权利要求8的制剂,其中c)部分含有锌和铜,其中锌对铜的重量比在5至12之间。
10.根据权利要求1或2的制剂,所述制剂进一步含有f)部分,选自肉碱、维生素B1、维生素B5和辅酶Q10中的一个或多个成员。
11.根据权利要求1或2的制剂,所述制剂进一步含有g)部分,选自维生素C、维生素E、硫辛酸、硒盐和类胡萝卜素中的一种或多种抗氧化剂。
12.根据权利要求1或2的制剂,所述制剂进一步含有h)部分,银杏提取物。
13.根据权利要求1或2的制剂,所述制剂每日剂量包含:
至少120mg长链多不饱和脂肪酸;
至少200mg磷脂;
至少200μg叶酸;以及
至少500mg柠檬酸盐。
14.根据权利要求13的制剂,所述制剂每日剂量包含:
至少20mg二十碳五烯酸;
至少50mg二十二碳六烯酸;
至少50mg花生四烯酸;
至少200mg磷脂;
至少200μg叶酸;
至少100mg镁;
至少5mg锌;
至少2mg维生素B6;
至少2μg维生素B12;
至少1.0g柠檬酸盐。
15.根据权利要求14的制剂,所述制剂每日剂量包含:
至少50mg二十碳五烯酸;
至少200mg二十二碳六烯酸;
至少100mg花生四烯酸;
至少1000mg磷脂;
至少400μg叶酸;
至少200mg镁;
至少10mg锌;
至少2.5mg维生素B6;
至少4μg维生素B12;
至少1.5g柠檬酸盐。
16.根据权利要求1的制剂,所述制剂为营养补剂。
17.根据权利要求1至16之任一项的制剂用以生产用于治疗和/或预防血管疾病或与之相关的继发疾病的药物、饮食或营养制剂的用途。
18.根据权利要求17的用途,其中血管疾病为动脉粥样硬化、动脉硬化、高胆固醇血症、高脂血症、高血压、心绞痛、痴呆综合征、脑血管意外、与缺血有关的暂时疾病、静脉血栓形成、产后血栓形成、心肌梗死、静脉曲张、血栓闭塞性脉管炎和闭塞性动脉硬化。
19.根据权利要求17的用途,其中继发血管疾病为痴呆综合征、认知退化或听力丧失。
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