CN101375926A - 用于预防出生缺陷并能改善记忆的药物组合物 - Google Patents
用于预防出生缺陷并能改善记忆的药物组合物 Download PDFInfo
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- CN101375926A CN101375926A CNA2008102231611A CN200810223161A CN101375926A CN 101375926 A CN101375926 A CN 101375926A CN A2008102231611 A CNA2008102231611 A CN A2008102231611A CN 200810223161 A CN200810223161 A CN 200810223161A CN 101375926 A CN101375926 A CN 101375926A
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- vitamin
- calcium
- magnesium
- zinc
- rhizoma atractylodis
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Abstract
一种用于预防出生缺陷并能改善记忆的药物组合物,该组合物包括白术、黄芪、维生素A、β-胡萝卜素、复合维生素B、维生素C、维生素D、维生素E和常量元素钙、钾、镁及微量元素锌、硒、铁、铬、铜、钼、碘、锰,主要适用于孕前妇女、孕妇、乳母,在预防出生缺陷并能改善记忆方面很有效,并且同时具有保健补益的功效,甚至长期施用也不会产生任何副作用。
Description
技术领域:本发明涉及医药保健品技术领域;尤其是用于预防出生缺陷并能改善记忆的药物组合物。
背景技术:出生缺陷是指胎儿在母体内及出生后器官形成过程中,由各种因素作用所致的胚胎及幼体发育紊乱,包括形态结构异常、生理代谢功能障碍、先天智力低下和宫内发育迟缓等4种类型;各国出生缺陷发生率高达出生总数的5%左右,对人口素质影响重大,给家庭、社会造成沉重的负担,已经成为目前全世界共同关注的一个重大公共卫生问题。
出生缺陷的发病因素很复杂,有遗传因素,环境因素,还有其它多种不确定因素。环境因素包括生物因素,物理因素,化学因素;胚胎受到环境有害因素和其它多种不确定因素的伤害,使出生缺陷发病率增高,而消除这些有害因素,就会使出生缺陷发病率减低。
本发明的药物组合物是遵循优生优育的方针,通过消除对胚胎的致出生缺陷因素,预防出生缺陷的发生,达到减低出生缺陷发病率的目的,同时对施用者有改善记忆的作用,有利母子两代人的健康;该组合物包括白术、黄芪、维生素A、β-胡萝卜素、复合维生素B、维生素C、维生素D、维生素E和常量元素钙、钾、镁及微量元素锌、硒、铁、铬、铜、钼、碘、锰。
白术是一种可做为保健食品的补气类天然中药材,有健脾益气,燥湿利水,止汗固表,和中安胎之功效;古代中医将白术列为中药之上品,安胎之君药,养胎之圣药;现代临床多用于肝硬化腹水,腹泻,默尼埃综合症,水肿自汗,胎动不安等;现代药理研究证实:1、白术有抗氧化作用,能减轻脂质过氧化反应,降低过氧化物的含量,避免有害物质对细胞结构和功能的破坏,并有提高SOD活性趋势,增强机体对自由基清除的能力,从而减少自由基对机体的损伤;2、白术有延缓衰老作用,白术煎剂能提高老龄小鼠红细胞的超氧化物歧化酶(SOD)活性,同时抑制脑单胺氧化酶活性,还能抑制红细胞的自氧化溶血,直接清除自由基,显示抗衰老作用;3、白术有增强免疫作用,白术煎剂口服可使淋巴细胞转化率及血清IgG含量显著上升,显示白术具有免疫刺激作用,并能增强巨噬细胞的活力,增强网状内皮系统的吞噬功能;4、抗癌瘤作用,白术挥发油对小鼠肉瘤S180有抑制作用,体外对艾氏腹水瘤细胞有直接杀灭作用,且在体外对Eca109食管癌细胞呈现抑制,可使细胞脱落,核固缩,染色质浓缩,细胞不分裂或极少分裂;5、白术还有降脂降糖作用,抗菌作用,抗凝血作用,促进幼小动物体重增加,体力增强作用,对由化学疗法或放射治疗肿瘤后引起的白细胞减少症可使白细胞数升高;中医习惯在组方内配伍白术以促进药物有效成份的吸收,特别是配伍金、石类药物以促进矿物质的吸收和利用。
黄芪是一种可做为保健食品的补气类天然中药材,具有补气升阳,益卫固表,托疮生肌,利水退肿之功效;临床用于治疗脾气虚弱证,气不摄血证,中气下陷证,脾肺气虚证,气血双亏证,气虚发热证,体虚多汗证,气虚水肿证,血痹麻木证,中风后遗证,消渴证,痈疽日久不溃或溃后久不收口等病症,现代药理研究证实黄芪具有:1、增强机体免疫和双向调节机体免疫功能;2、抗衰老功能;3、增智和加强学习记忆的作用;4、抗疲劳作用;5、抗缺氧作用;6、抗辐射作用;7、抗寒作用;9、抗突变作用;10、抑瘤作用;11、抗菌、抗病毒、抗炎作用;12、保肝、保肾、利尿、护胃作用;13、促进骨生长作用;14、有促雌激素样作用;15、强心、扩张血管、降压等作用;16、促进蛋白质合成作用;17、调节血糖作用;18.延长动物细胞寿命的作用等。
维生素A也称视黄醇,有提高视力、防止夜盲的作用,有增强孕妇机体抵抗力功能,能促进粘多糖合成,影响骨组织的更新、发育,使长骨向双端生长;若维生素A缺乏易出现早产或胎儿先天性畸形。β-胡萝卜素在体内酶的作用下可转变为维生素A,发挥维生素A的作用。
B族维生素参与机体内蛋白质、脂肪和糖代谢,使脑细胞的兴奋和抑制处于平衡状态,它包括维生素B1、维生素B2、烟酰胺、泛酸、生物素、维生素B6、维生素B12、叶酸等,在体内协同发挥生理作用。维生素B1具有维持神经系统正常功能的作用,缺乏时出现糖代谢不完全,热能供应不足等现象,从而导致记忆力下降,影响脑的正常功能,如果维生素B1充足,即能有效形成脑细胞活动必要的能源,可提高记忆力,集中力及学习能力,此外维生素B1还有抑制胆碱脂酶,改善胆碱能神经的功能;维生素B2又名核黄素,是机体中许多重要辅酶的组成部分,其参与体内的物质代谢,对维持生命活动促进胎儿和婴儿的生长发育有重要作用,维生素B2是维持皮肤和眼睛健康所必不可少的维生素,孕妇维生素B2缺乏或不足可引起或促发孕早期妊娠呕吐,孕中期口角炎、舌炎、唇炎及早产儿发生率增加;烟酰胺又称尼克酰胺或维生素PP,其生理功能是参与体内新陈代谢,维持正常神经系统功能,保证性激素等的合成,缺乏时可发生癞皮病,主要表现为皮炎、腹泻、痴呆三大症状;泛酸在每一生物体内广泛存在,参与广泛的代谢活动,已知有70多种酶在催化机体各类生物化学反应中都需要泛酸参与,否则便会代谢失调;生物素也是一种B族维生素,与其它B族维生素协调参与人体物质和能量代谢,它与核酸的合成,性激素的合成关系密切,它还具有防治白发、秃头的功效;维生素B6对中枢神经发育至关重要,如果缺乏会使中枢神经发育迟缓,智力下降,它有协助维生素B1的作用,是可以提高集中力及刺激学习欲望的维生素;维生素B12参与体内核酸,胆碱,氨基酸的合成及脂肪与糖的代谢,对骨髓造血功能,消化道上皮细胞功能,肝脏功能和神经系统髓鞘功能的完整有一定作用,它是发挥正常智力所必须的维生素,如果缺乏不仅造成智力障碍,还会出现营养性贫血,影响对脑中血液供给;叶酸参与氨基酸和核酸的合成,并与维生素B12共同促进细胞的生成与成熟,缺乏时正常细胞不能进行有丝分裂,会出现神经病学的症状,如:记忆丧失,抑郁症及痴呆症等;另外人体可在维生素B12和叶酸做为辅酶因子的作用下,由摄入的丝氨酸和蛋氨酸合成胆碱,胆碱是乙酰胆碱的主要组成部分,乙酰胆碱是人体内重要的神经递质;再有,叶酸、维生素B6和维生素B12可协同清除人体内的同型半光氨酸,同型半光氨酸是一种神经毒素,可以引起脑的自我毁灭;有研究表明,同型半胱氨酸是一种独立的发育潜在致畸因子,与先天性心脏病和神经管畸形发生关系密切;此外同型半胱氨酸还可引起流产、早产,先兆子痫等临床恶果。
维生素C又称抗坏血酸,维生素C与胶原的关系密切,不仅有软化血管作用,还有净化血液的作用,防止动脉硬化,还能促进人体对食物中铁的吸收,为血细胞生成提供必需的原料,同时,维生素C在恢复体力、消除疲劳、缓解紧张情绪等方面作用明显;妊娠期间,孕妇维生素C缺乏或不足会出现皮下出血,牙龈肿胀、流血、溃烂等症状,长期缺乏维生素C易患病毒性感冒,增加胎儿致畸的危险性,严重缺乏会导致流产。
维生素D是甾醇类衍生物,人体皮下脱氢胆固醇经紫外线照射产生维生素D3,麦角固醇经紫外线照射后产生维生素D2,二者来源不同,功能一致,在人类营养中维生素D的重要性在于调节钙和磷的代谢作用;维生素D促进钙在小肠吸收,缺乏维生素D则大量钙由粪便排出,从而引起人体缺钙,儿童会发生佝偻病,成人体内贮存的钙磷耗尽会引起软骨病,最常见的软骨病人群是孕妇、乳母和老年人。
维生素E是所有具有α-生育酚生物活性的色酮衍生物的统称,其中α-生育酚的活性最高。具有消除自由基、延缓衰老、预防大细胞性溶血性贫血的作用,在医学上常采用维生素E治疗男女不孕症及先兆性流产;维生素E缺乏或不足可使孕妇生殖系统受到损害,生殖上皮发生不可逆的变化,另外,还可发生大细胞性溶血性贫血和红细胞寿命缩短等现象。
钙是人体重要的常量元素,主要起两方面的作用,一是构成骨齿等硬组织,二是与蛋白质结合或以钙离子的形式构成有特定功能的物质,形成所谓混溶钙池与骨齿中钙维持动态平衡,体内所有的细胞均需要钙才能发挥其正常功能;孕妇和乳母缺钙会影响其体质和胎儿或婴幼儿的发育,缺钙还会引起内分泌功能紊乱及细胞生长调节失灵,而孕妇和乳母由于生理上的特点,普遍存在钙的摄入不足。
钾参与细胞的新陈代谢活动,为某些酶的正常活动提供适宜的条件,其突出的作用是维持心肌细胞正常的兴奋性、自律性和传导性,在调节酸碱平衡,维持渗透压及保持水平衡方面起到重要作用;低血钾和高血钾对人体都会产生严重的损害,轻者可导致疲倦、烦躁,重者可造成心律失常,甚至死亡。
镁在人体内最主要的功能是遏制自由基的产生,自由基是促衰老的因素,也是主要致出生缺陷的因素;镁的另一项功能是与钙和维生素D一起发挥保护骨骼的作用,缺镁容易发生骨质疏松症,容易发生骨折;此外镁还有保护心脏和防治糖尿病的功能等。
微量元素锌被融合在生物大分子配位体——蛋白质、核酸、膜(主要为膜蛋白)中,生成稳定的含金属的生物大分子络合物——金属蛋白、金属核酸络合物等,目前,已知这些物质参与碳水化合物、脂类、蛋白质及核酸的合成和降解过程,在六大类酶中都有含锌酶的存在;锌也是增强免疫活力的主要元素;锌能通过激活羧肽酶B促进胰岛素原转化为胰岛素,缺锌使胰岛素在外周组织的活性受阻,致糖耐量曲线异常;孕妇缺锌,会不同程度地影响胎儿的生长发育,以致引起胎儿的种种畸形;缺锌可导致大脑发育不良,智力发育不健全。
微量元素硒有明显降低血清总胆固醇、甘油三酯和脂质过氧化物,提高高密度脂蛋白,加速体内多余脂肪代谢的作用;硒还具有强抗氧化功能,保护胚胎不受超氧化物的伤害,预防心脏病;通过增强免疫识别系统清除癌细胞而抗癌;解除和排泄重金属离子,对汞、甲基汞、镉、铅等有解毒作用,而重金属污染是主要致出生缺陷因素;缺硒可使人体胰岛素分泌减少,糖耐量减低,抗氧化能力下降而加速人体衰老和智力下降。
微量元素铁的主要生理功能是作为血红蛋白、肌红蛋白,细胞色素等的组成部分参与体内氧的运送和组织呼吸过程;在氧和电子的输送中起着核心作用;过氧化氢酶的结构中含有铁,而过氧化氢依靠过氧化氢酶的降解,过氧化氢是人体内最险恶的自由基;铁缺乏常见于婴幼儿、孕妇和乳母,导致缺铁性贫血,其主要症状是体质虚弱,记忆力减弱,工作能力下降,缺铁还可对人体的其它系统产生影响;如神经系统缺铁,可影响神经传导而使儿童出现智力降低和行为障碍。
铬是一种必需的微量元素,只有三价铬能用于铬的补充剂,它能增强和促进胰岛素的生理作用,它能预防动脉硬化,增强免疫功能,促进生长发育;缺铬会导致生长发育停滞,加速衰老。
铜在人体内主要以含铜金属酶的形式发挥作用,参与铁的利用、造血、磷脂的合成,胶原结缔组织形成等一系列新陈代谢过程;铜的缺乏会导致结缔组织中胶原交联障碍,心脏病以及贫血、白细胞减少,动脉壁弹性减弱、白化病等。
钼是人体必需微量元素之一,它是多种酶的构成元素,参与铁的利用,促进红细胞的发育和成熟,可预防贫血,并能帮助碳水化合物和脂肪的代谢,它参与解除人体内有毒醛类的毒害,消除人体自由基,具有抗癌、抗衰老,增强免疫力及防龋齿的功能;缺钼可诱发心血管疾病、癌症及龋齿。
碘在人体内主要参与合成甲状腺素,甲状腺素的生理功能是调节机体代谢水平,影响机体热能产生、血糖与酮体水平,肌肉与神经紧张,体重、智力与性功能等多方面功能;成人缺碘可引起甲状腺肿大,胎儿及新生儿缺碘可引起不同程度的聋哑、痴呆、身材矮小、痉挛性瘫痪、智力低下、小头。低位耳等严重病症。
锰在人体内参与一些酶的构成,它不仅参与糖和脂类的代谢,而且在蛋白质、DNA和RVA合成中均起作用。
应用含有白术、黄芪、维生素A、β-胡萝卜素、维生素B1、维生素B2、维生素B6、烟酰胺、泛酸、生物素、维生素B12、叶酸、维生素C、维生素D、维生素E和常量元素钙、钾、镁及微量元素锌、硒、铁、铬、铜、钼、碘、锰作为有效组分的组合物已为人所知,但将白术、黄芪、维生素A、β-胡萝卜素、维生素B1、维生素B2、烟酰胺、泛酸、生物素、维生素B6、维生素B12、叶酸、维生素C、维生素D、维生素E和常量元素钙、钾、镁及微量元素锌、硒、铁、铬、铜、钼、碘、锰配伍用于预防出生缺陷并能改善记忆的药物组合物尚未报道。
当前用于改善记忆的药品或保健食品种类有多种,但专为孕前妇女、孕妇、乳母研制的用于改善记忆的药品或保健食品尚未见到;尚未见到用于预防出生缺陷的药品标签,仅见有叶酸预防神经管畸形的报导;但其靶点少,环节欠缺,需要完善。而将预防出生缺陷并能改善记忆的功效并用于同一药物者尚未见到。
发明内容:为了克服现有预防出生缺陷和/或改善记忆药物的缺点和不足,本发明的目的是提供一种组合物,该组合物通过白术促进维生素、矿物质的吸收与利用,并与黄芪协同增加维生素A、β-胡萝卜素、维生素B1、维生素B2、烟酰胺、泛酸、生物素、维生素B6、维生素B12、叶酸、维生素C、维生素D、维生素E和常量元素钙、钾、镁及微量元素锌、硒、铁、铬、铜、钼、碘、锰改善记忆和预防出生缺陷之功效,同时通过常量元素钙、钾、镁和微量元素锌、硒、铁、铬、铜、钼、碘、锰及维生素A、β-胡萝卜素、维生素B1、维生素B2、烟酰胺、泛酸、生物素、维生素B6、维生素B12、叶酸、维生素C、维生素D、维生素E,补充和增强白术养胎安胎及白术与黄芪增智、抗突变、抗氧化、抗衰老、增强免疫、抗肿瘤、降脂降糖的效果;即使长期施用也没有任何副作用。由于广泛研究的结果,本发明人发现了白术与黄芪和维生素A、β-胡萝卜素、维生素B1、维生素B2、烟酰胺、泛酸、生物素、维生素B6、维生素B12、叶酸、维生素C、维生素D维生素E与常量元素钙、钾、镁及微量元素锌、硒、铁、铬、铜、钼、碘、锰的新型组合,这一新型组合对于预防出生缺陷并能改善记忆有协同效果;而单用白术、黄芪和维生素A、β-胡萝卜素、复合维生素B、维生素C、维生素D、维生素E与常量元素钙、钾、镁及微量元素锌、硒、铁、铬、铜、钼、碘、锰,其效果均不及本组合物;并且各组分的有效成分对人体的保健补益具有相加互补作用,如本组合物所用剂量的白术有养胎安胎、抗衰老、增强免疫和增强体力的作用;黄芪具有补气升阳、益卫固表、托疮生肌、利水退肿之功效;微量元素锌是人体内六大类酶中含锌酶的必要物质,也是增强免疫活力的主要元素;微量元素硒可加速体内多余脂肪的代谢,具有强抗氧化功能,预防心脏病功能、抗癌功能等;微量元素铁参与体内氧的运送和组织呼吸过程,是防止缺铁性贫血的唯一元素;微量元素铬具有预防动脉硬化,增强免疫、抗衰老的功能;微量元素铜参与铁的利用、造血、磷脂的合成;微量元素钼具有抗癌、抗衰老,增强免疫及防龋齿的功能;微量元素碘可防治缺碘引起的甲状腺肿,可预防胎儿及新生儿缺碘引起呆小症、智力低下等严重发育不良症;微量元素锰参与蛋白质、DNA和RNA的合成;又如维生素A有提高视力,防止夜盲症等的作用;维生素B1可防治脚气病,维持神经、消化、肌肉、循环系统的正常活动;维生素B2是维持皮肤和眼睛健康必不可少的维生素;烟酰胺缺乏可发生癞皮病;泛酸缺乏会引起代谢失调;生物素可防治白发、秃发;维生素B6可消灭癌前病变细胞,增强免疫功能,保护血管;维生素B12用于各种巨幼红细胞性贫血,和神经系统的疾病;叶酸还有保护心脏和抗癌作用;维生素C有软化血管,净化血液,防止动脉硬化的作用;维生素E具有清除自由基、延缓衰老的作用;常量元素钾维持心肌细胞正常的兴奋性、自律性和传导性;常量元素钙、镁和维生素D共同发挥保护骨骼的作用;本组合物不存在配伍禁忌,无毒副作用,并且成本低,从而构成本发明。
本发明提供了用于预防出生缺陷并能改善记忆的药物组合物,它包括作为有效组分的白术、黄芪和维生素A、β-胡萝卜素、维生素B1、维生素B2、烟酰胺、泛酸、生物素、维生素B6、维生素B12、叶酸、维生素C、维生素D、维生素E与常量元素钙、钾、镁及微量元素锌、硒、铁、铬、铜、钼、碘、锰。
白术为菊科多年生草本植物白术(Atractylodes macrocephala koidz)的根茎。主产于浙江、湖北、湖南等地。冬季采收,烘干或晒干,生用或土炒、麸炒用。本发明所用的白术可用其提取物做为原料。
黄芪为豆科植物黄芪属(Astragalus spp)中的膜荚黄芪(A.membranaceus)和蒙古黄芪(A.m.var.mongholicus)为主的植物4-10年的根供用;主要分布于我国东北、华北、西北等地区,亦产于加拿大、印度等地,以蒙古黄芪最有名,山西黄芪质量最好;本发明所用黄芪可用其提取物做为原料。
用于本发明的维生素B1(VitaminB1)、维生素B2(VitaminB2)、烟酰胺(Nicotinamide)、泛酸(Pantothenic Acid)、生物素(Vitamin H)、维生素B6(VitaminB6)、维生素B12(VitaminB12)、叶酸(Folic Acid),维生素C(VitaminC)、均是水溶性维生素,在体内没有蓄积;维生素A(Vitamin A)、维生素D(VitaminD)、维生素E(Vitamin E)是脂溶性维生素,β-胡萝卜素(Beta Carotene)是维生素A的前体物质,按本发明所用剂量有益无害;锌(Zn)、硒(Se)、铁(Fe)、铬(Cr)、铜(Cu)、钼(Mo)、碘(I)为人体必需微量元素,锰(Mn)为人体可能必需微量元素,钙(Ca)、钾(K)、镁(Mg)是人体必需的常量元素;本发明中的常量元素钙可选用葡萄糖酸钙、醋酸钙、酪蛋白钙、氯化钙、柠檬酸钙、苹果酸钙、柠檬酸苹果酸钙、磷酸氢钙、磷酸二氢钙、磷酸钙、硫酸钙、抗坏血酸钙、甘油磷酸钙、乳酸钙、碳酸钙等,常量元素钾可选用碳酸钾、氯化钾、柠檬酸钾、磷酸氢二钾、葡萄糖酸钾、硫酸钾、甘油磷酸钾、乳酸钾等,常量元素镁可选用氯化镁、葡萄糖酸镁、乳酸镁、柠檬酸镁、磷酸氢镁、磷酸镁、甘油磷酸镁、碳酸镁等,微量元素锌可选用柠檬酸锌、葡萄糖酸锌、醋酸锌、碳酸锌、氧化锌、氯化锌、乳酸锌、硫酸锌、单蛋氨酸锌等,微量元素硒可选用硒蛋氨酸、甲氧基苄氰酸硒、次苯基双氰酸硒、亚硒酸钠、硒化卡拉胶、半胱氨酸硒、硒化甲硫氨酸、硒酸钠等,微量元素铁可选用葡萄糖酸亚铁、乳酸亚铁、柠檬酸铁铵、氯化铁、柠檬酸铁、碳酸亚铁、柠檬酸亚铁、富马酸亚铁、血红素铁、焦磷酸铁、氯化高铁血红素、琥珀酸亚铁、硫酸亚铁等,微量元素铬可选用三氯化铬、烟酸铬、吡啶甲酸铬、铬酵母等,微量元素铜可选用碳酸铜、柠檬酸铜、葡萄糖酸铜、硫酸铜等,微量元素钼可选用钼酸铵、钼酸钠等,微量元素碘可选用碘酸钾等,微量元素锰可选用硫酸锰、葡萄糖酸锰、甘油磷酸锰、氯化锰、柠檬酸锰等,均有专业生产厂及供货商。
本发明的组合物主要适用于孕前期妇女,孕妇及乳母;受地质、食物链、饮食生活习惯以及服用时间长短等因素的影响,受用人群对本组合物各组份受用的有效用量会有一定差别;按本发明,白术提取物的有效用量以整体天然药材计为300—15000mg/天,黄芪提取物的有效用量以整体天然药材计为300—10000mg/天,维生素B1的有效用量为0.5—20mg/天,维生素B2的有效用量为0.5—20mg/天,烟酰胺的有效用量为5—50mg/天,泛酸的有效用量为2—20mg/天,生物素的有效用量为0.01—0.1mg/天,维生素B6的有效用量为0.5—10mg/天,维生素B12的有效用量为0.001—0.025mg/天,叶酸的有效用量为0.1—1mg/天,维生素C的有效用量为30—500mg/天,维生素A和/或β-胡萝卜素的有效用量(以视黄醇当量计)为250—800μgRE/天;维生素D的有效用量为0.0015—0.01mg/天,维生素E的有效用量(以α-生育酚当量计)为5—150mg α-TE/天,常量元素钙的有效用量以元素钙计为250—1000mg/天,钾的有效用量以元素钾计为200—1200mg/天,镁的有效用量以元素镁计为100—300mg/天,微量元素锌的有效用量以元素锌计为5—20mg/天,硒的有效用量以元素硒计为0.015—0.1mg/天,铁的有效用量以元素铁计为5—20mg/天。铬的有效用量以元素铬计为0.015—0.15mg/天,铜的有效用量以元素铜计为0.5—1.5mg/天,钼的有效用量以元素钼计为0.02—0.06mg/天,碘的有效用量以元素碘计为0.05—0.2mg/天,锰的有效用量以元素锰计为1—3mg/天。
本发明的组合物可按下列药物制剂形式施药或直接服用,例如,口服制剂(如颗粒、粉末、胶囊、丸、片、干糖浆、液态制剂),或食物如固体食物(如饼干),是与其它已知的添加剂混合而制备的,这类添加剂例如:载体、崩解剂、缓释剂、赋形剂、填充剂、包覆剂、粘结剂、润滑剂、抗氧剂、涂覆剂、着色剂、矫味剂、甜味剂、蔗糖替代品、营养强化剂、香味剂、表面活性剂、增塑剂、PH调节剂、清新剂、悬浮剂、消泡剂、防腐剂、增稠剂、增溶助剂等,按通常的方法进行制备或者将它们作为功能性组分或添加剂加入食物。
按本发明,白术、黄芪、维生素A、β-胡萝卜素、维生素B1、维生素B2、烟酰胺、泛酸、生物素、维生素B6、维生素B12、叶酸、维生素C、维生素D、维生素E和常量元素钙、钾、镁及微量元素锌、硒、铁、铬、铜、钼、碘、锰各组份可分别制剂,施用时可将各组份的制剂混合后使用或不同时混合而使用。
本发明的优点是本组合物从多环节、多系统、多靶点消除致出生缺陷和致记忆力下降的多种因素,各组份之间有协同发挥功效的作用,对预防出生缺陷并能改善记忆有显著的效果,原料来源充足,成本低,组合物中各组分无毒副作用,无配伍禁忌,除预防出生缺陷并能改善记忆外,对人体尚有保健补益作用。
附表1为本组合物与白术及黄芪组份和维生素加元素组份青年小鼠迷宫试验效果比较。
附表2为本组合物与白术及黄芪组份和维生素加元素组份老年小鼠迷宫试验效果比较。
下面将参考实施例及测试实施例效果比较列表来详细叙述本发明。
实施例1:
白术 2000mg,
黄芪 500mg,
叶酸 0.3mg,
维生素B6 2mg,
维生素B12 0.003mg,
维生素B1 3mg,
维生素B2 3mg,
烟酰胺 10mg,
维生素C 30mg,
乳酸锌(以微量元素锌计) 10mg,
硒酸钠(以微量元素硒计) 0.02mg,
柠檬酸铁(以微量元素铁计) 10mg,
碘酸钾(以微量元素碘计) 0.1mg,
乳酸钙(以元素钙计) 600mg,
视黄醇当量(维生素A和/或β-胡萝卜素) 300μg RE,
维生素D 0.002mg,
维生素E(以α-生育酚当量计) 10mg α-TE。
将上述组分进一步与适当量的添加剂如硅铝酸镁、聚溶剂化物60和丙二醇均匀地混合,将所得混合物均匀地填入胶囊而得9颗胶囊,每日3次,每次3颗胶囊。
实施例2:
白术 2000mg,
黄芪 500mg,
叶酸 0.3mg,
维生素B6 2mg,
维生素B12 0.003mg,
维生素B1 3mg,
维生素B2 3mg,
烟酰胺 10mg,
维生素C 30mg,
乳酸锌(以微量元素锌计) 8mg,
硒酸钠(以微量元素硒计) 0.02mg,
柠檬酸铁(以微量元素铁计) 10mg,
碘酸钾(以微量元素碘计) 0.1mg,
乳酸钙(以元素钙计) 600mg,
乳酸镁(以元素镁计) 200mg,
视黄醇当量(维生素A和/或β-胡萝卜素) 300μg RE,
维生素D 0.002mg,
维生素E(以α-生育酚当量计) 10mg α-TE。
将上述组分进一步与适当量的添加剂如硅铝酸镁、聚溶剂化物60和丙二醇均匀地混合,将所得混合物均匀地填入胶囊而得9颗胶囊,每日3次,每次3颗胶囊。
实施例3:
白术 2000mg,
黄芪 500mg,
叶酸 0.3mg,
维生素B6 2mg,
维生素B12 0.003mg,
维生素B1 3mg,
维生素B2 3mg,
烟酰胺 10mg,
维生素C 30mg,
乳酸锌(以微量元素锌计) 10mg,
硒酸钠(以微量元素硒计) 0.02mg,
柠檬酸铁(以微量元素铁计) 10mg,
碘酸钾(以微量元素碘计) 0.1mg,
铬酵母(以微量元素铬计) 0.02mg,
柠檬酸铜(以微量元素铜计) 0.8mg,
钼酸钠(以微量元素钼计) 0.03mg,
乳酸钙(以元素钙计) 600mg,
视黄醇当量(维生素A和/或β-胡萝卜素) 300μg RE,
维生素D 0.002mg,
维生素E(以α-生育酚当量计) 10mg α-TE。
将上述组分进一步与适当量的添加剂如硅铝酸镁、聚溶剂化物60和丙二醇均匀地混合,将所得混合物均匀地填入胶囊而得9颗胶囊,每日3次,每次3颗胶囊。
实施例4:
白术 2000mg,
黄芪 500mg,
叶酸 0.3mg,
维生素B6 2mg,
维生素B12 0.003mg,
维生素B1 3mg,
维生素B2 3mg,
烟酰胺 10mg,
维生素C 30mg,
乳酸锌(以微量元素锌计) 10mg,
硒酸钠(以微量元素硒计) 0.02mg,
柠檬酸铁(以微量元素铁计) 10mg,
碘酸钾(以微量元素碘计) 0.1mg
铬酵母(以微量元素铬计) 0.02mg,
柠檬酸铜(以微量元素铜计) 0.8mg,
钼酸钠(以微量元素钼计) 0.03mg,
乳酸钙(以元素钙计) 600mg,
乳酸镁(以元素镁计) 200mg,
视黄醇当量(维生素A和/或β-胡萝卜素) 300μg RE,
维生素D 0.002mg,
维生素E(以α-生育酚当量计) 10mg α-TE。
将上述组份进一步与适当量的添加剂如甘露糖醇、羟丙基纤维素、硅铝酸镁和调味剂均匀地混合,再将所得混合物制成3包粒状物。每日服3次,每次服一包。
实施例5:
白术 300mg,
黄芪 300mg,
叶酸 0.1mg,
维生素B6 0.5mg,
维生素B12 0.001mg,
维生素B1 0.5mg,
维生素B2 0.5mg,
烟酰胺 5mg,
泛酸 2mg,
生物素 0.01mg,
维生素C 30mg,
乳酸锌(以微量元素锌计) 5mg,
硒酸钠(以微量元素硒计) 0.015mg,
柠檬酸铁(以微量元素铁计) 5mg,
碘酸钾(以微量元素碘计) 0.05mg,
铬酵母(以微量元素铬计) 0.015mg,
柠檬酸铜(以微量元素铜计) 0.5mg,
钼酸钠(以微量元素钼计) 0.02mg,
柠檬酸锰(以微量元素锰计) 1mg,
乳酸钙(以元素钙计) 250mg,
乳酸钾(以元素钾计) 200mg
乳酸镁(以元素镁计) 100mg,
视黄醇当量(维生素A和/或β-胡萝卜素) 250μg RE,
维生素D 0.0015mg,
维生素E(以α-生育酚当量计) 5mg α-TE。
将上述组份进一步与适当量的添加剂如甘露糖醇、羟丙基纤维素、硅铝酸镁和调味剂均匀地混合,再将所得混合物制成3包粒状物。每日服3次,每次服一包。
实施例6:
白术 15000mg,
黄芪 10000mg,
叶酸 1mg,
维生素B6 10mg,
维生素B12 0.025mg,
维生素B1 20mg,
维生素B2 20mg,
烟酰胺 50mg,
泛酸 20mg,
生物素 0.1mg,
维生素C 500mg,
乳酸锌(以微量元素锌计) 20mg,
硒酸钠(以微量元素硒计) 0.1mg,
柠檬酸铁(以微量元素铁计) 20mg,
碘酸钾(以微量元素碘计) 0.2mg,
铬酵母(以微量元素铬计) 0.15mg,
柠檬酸铜(以微量元素铜计) 1.5mg,
钼酸钠(以微量元素钼计) 0.06mg,
柠檬酸锰(以微量元素锰计) 3mg,
乳酸钙(以元素钙计) 1000mg,
乳酸钾(以元素钾计) 1200mg
乳酸镁(以元素镁计) 300mg,
视黄醇当量(维生素A和/或β-胡萝卜素) 800μg RE,
维生素D 0.01mg,
维生素E(以α-生育酚当量计) 150mg α-TE。
将上述组份进一步与适当量的添加剂如甘露糖醇、羟丙基纤维素、硅铝酸镁和调味剂均匀地混合,再将所得混合物制成3包粒状物。每日服3次,每次服一包,连服7日,停服2日再服7日。
经动物试验证实本组合物属无毒级;人群服用也未见毒副反应。
附表1:本组合物与白术及黄芪组份和维生素加元素组份青年小鼠迷宫试验效果比较:
组别 | 药物 | 用量 | 样本数 | 错误百分率 |
A组 | 对照组 | 0 | 12 | 21.6% |
B组 | 白术及黄芪组 | 白术100mg+黄芪50mg/天 | 12 | 1.84% |
C组 | 维生素+元素组 | 钙10mg+镁5mg+锌0.1mg+铁0.1mg+硒0.001mg+碘0.003mg+VB10.1mg+VB20.1mg+烟酰胺0.2mg+VB60.08mg+VB120.0001mg+叶酸0.008mg+VC1mg+VD0.0001mg+(VA和/或β-胡萝卜素)按视黄醇当量计10μgRE+VE(以α-生育酚当量计)0.5mg α-TE/天 | 12 | 15.2% |
D组 | 白术及黄芪+维生素+元素组 | 白术100mg+黄芪50mg+钙10mg+镁5mg+锌0.1mg+铁0.1mg+硒0.001mg+碘0.003mg+VB10.1mg+VB20.1mg+烟酰胺0.2mg+VB60.08mg+VB120.0001mg+叶酸0.008mg+VC1mg+VD0.0001mg+(VA和/或β-胡萝卜素)按视黄醇当量计10μgRE+VE(以α-生育酚当量计)0.5mg α-TE/天 | 12 | 13.5% |
附表2:本组合物与白术及黄芪组份和维生素加元素组份老年小鼠迷宫试验效果比较:
组别 | 药物 | 用量 | 样本数 | 错误百分率 |
A组 | 对照组 | 0 | 12 | 53.3% |
B组 | 白术及黄芪组 | 白术100mg+黄芪50mg/天 | 12 | 34% |
C组 | 维生素+元素组 | 钙10mg+镁5mg+锌0.1mg+铁0.1mg+硒0.001mg+碘0.003mg+VB10.1mg+VB20.1mg+烟酰胺0.2mg+VB60.08mg+VB120.0001mg+叶酸0.008mg+VC1mg+VD0.0001mg+(VA和/或β-胡萝卜素)按视黄醇当量计10μgRE+VE(以α-生育酚当量计)0.5mg α-TE/天 | 12 | 30.8% |
D组 | 白术及黄芪+维生素+元素组 | 白术100mg+黄芪50mg+钙10mg+镁5mg+锌0.1mg+铁0.1mg+硒0.001mg+碘0.003mg+VB10.1mg+VB20.1mg+烟酰胺0.2mg+VB60.08mg+VB120.0001mg+叶酸0.008mg+VC1mg+VD0.0001mg+(VA和/或β-胡萝卜素)按视黄醇当量计10μgRE+VE(以α-生育酚当量计)0.5mg α-TE/天 | 12 | 27.7% |
注:附表1、附表2中各组分别按表中剂量喂饲60天进行测试;表中用量按每公斤体重换算;锌、硒、铁、碘以微量元素计,钙、钾、镁以元素计。
选新婚健康妇女50名,平均年龄25岁,从孕前3个月开始连续服用本组合物,至婴儿出生后6个月随访,无一例出生缺陷。与相关材料统计数字对照,出生缺陷儿约占出生人口总数的4—6%有显著差异。
从表1、表2可明显看出,本组合物通过小鼠迷宫试验与组合物中的中药组份与维生素加元素组份对照,错误百分率统计结果,本组合物改善记忆的功能优于中药组份或维生素加元素组份;与空白对照组比较有显著的差异。
Claims (5)
1、一种用于预防出生缺陷并能改善记忆的药物组合物,其特征是,它由下列原料按重量配比制成:
白术 300—15000mg,
黄芪 300—10000mg,
叶酸 0.1—1mg,
维生素B6 0.5—10mg,
维生素B12 0.001—0.025mg,
维生素B1 0.5—20mg,
维生素B2 0.5—20mg,
烟酰胺 5—50mg,
泛酸 0—20mg,
生物素 0—0.1mg,
维生素C 30—500mg,
锌 5—20mg,
硒 0.015—0.1mg,
铁 5—20mg,
铬 0—0.15mg,
铜 0—1.5mg,
钼 0—0.06mg,
碘 0.05—0.2mg,
锰 0—3mg,
钙 250—1000mg,
钾 0—1200mg,
镁 0—300mg,
视黄醇当量[维生素A和/或β-胡萝卜素] 250—800μgRE,
维生素D 0.0015—0.01mg,
维生素E 5—150mg a-TE。
2、根据权利要求1所述的用于预防出生缺陷并能改善记忆的药物组合物,其特征是,它由下列原料按重量配比制成:
白术 300—15000mg,
黄芪 300—10000mg,
叶酸 0.1—1mg,
维生素B6 0.5—10mg,
维生素B12 0.001—0.025mg,
维生素B1 0.5—20mg,
维生素B2 0.5—20mg,
烟酰胺 5—50mg,
泛酸 0—20mg,
生物素 0—0.1mg,
维生素C 30—500mg,
锌 5—20mg,
硒 0.015—0.1mg,
铁 5—20mg,
铬 0—0.15mg,
铜 0—1.5mg,
钼 0—0.06mg,
碘 0.05—0.2mg,
锰 0—3mg,
钙 250—1000mg,
钾 0—1200mg,
镁 100—300mg,
视黄醇当量[维生素A和/或β-胡萝卜素] 250—800μgRE,
维生素D 0.0015—0.01mg,
维生素E 5—150mg a-TE。
3、根据权利要求1所述的用于预防出生缺陷并能改善记忆的药物组合物,其特征是,它由下列原料按重量配比制成:
白术 300—15000mg,
黄芪 300—10000mg,
叶酸 0.1—1mg,
维生素B6 0.5—10mg,
维生素B12 0.001—0.025mg,
维生素B1 0.5—20mg,
维生素B2 0.5—20mg,
烟酰胺 5—50mg,
泛酸 0—20mg,
生物素 0—0.1mg,
维生素C 30—500mg,
锌 5—20mg,
硒 0.015—0.1mg,
铁 5—20mg,
铬 0.015—0.15mg,
铜 0.5—1.5mg,
钼 0.02—0.06mg,
碘 0.05—0.2mg,
锰 0—3mg,
钙 250—1000mg,
钾 0—1200mg,
镁 0—300mg,
视黄醇当量[维生素A和/或β-胡萝卜素] 250—800μgRE,
维生素D 0.0015—0.01mg,
维生素E 5—150mg a-TE。
4、根据权利要求1所述的用于预防出生缺陷并能改善记忆的药物组合物,其特征是,它由下列原料按重量配比制成:
白术 300—15000mg,
黄芪 300—10000mg,
叶酸 0.1—1mg,
维生素B6 0.5—10mg,
维生素B12 0.001—0.025mg,
维生素B1 0.5—20mg,
维生素B2 0.5—20mg,
烟酰胺 5—50mg,
泛酸 0—20mg,
生物素 0—0.1mg,
维生素C 30—500mg,
锌 5—20mg,
硒 0.015—0.1mg,
铁 5—20mg,
铬 0.015—0.15mg,
铜 0.5—1.5mg,
钼 0.02—0.06mg,
碘 0.05—0.2mg,
锰 0—3mg,
钙 250—1000mg,
钾 0—1200mg,
镁 100—300mg,
视黄醇当量[维生素A和/或β-胡萝卜素] 250—800μgRE,
维生素D 0.0015—0.01mg,
维生素E 5—150mg a-TE。
5、根据权利要求1所述的用于预防出生缺陷并能改善记忆的药物组合物,其特征是,它由下列原料按重量配比制成:
白术 300—15000mg,
黄芪 300—10000mg,
叶酸 0.1—1mg,
维生素B6 0.5—10mg,
维生素B12 0.001—0.025mg,
维生素B1 0.5—20mg,
维生素B2 0.5—20mg,
烟酰胺 5—50mg,
泛酸 2—20mg,
生物素 0.01—0.1mg,
维生素C 30—500mg,
锌 5—20mg,
硒 0.015—0.1mg,
铁 5—20mg,
铬 0.015—0.15mg,
铜 0.5—1.5mg,
钼 0.02—0.06mg,
碘 0.05—0.2mg,
锰 1—3mg,
钙 250—1000mg,
钾 200—1200mg,
镁 100—300mg,
视黄醇当量[维生素A和/或β-胡萝卜素] 250—800μgRE,
维生素D 0.0015—0.01mg,
维生素E 5—150mg a-TE。
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