CN101461868A - 用于降低血糖与血脂和治疗糖尿病的药物组合物 - Google Patents
用于降低血糖与血脂和治疗糖尿病的药物组合物 Download PDFInfo
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- CN101461868A CN101461868A CNA2008102399701A CN200810239970A CN101461868A CN 101461868 A CN101461868 A CN 101461868A CN A2008102399701 A CNA2008102399701 A CN A2008102399701A CN 200810239970 A CN200810239970 A CN 200810239970A CN 101461868 A CN101461868 A CN 101461868A
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- zinc
- chromium
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Abstract
一种用于降低血糖与血脂和治疗糖尿病的药物组合物,该组合物包括枸杞子、山茱萸、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、镁及微量元素锌、硒、铬、钼,主要适用于高血糖、高血脂和糖尿病人群,在降低血糖与血脂和治疗糖尿病方面很有效,可长期施用或按疗程施用。
Description
技术领域:本发明涉及医药保健品技术领域;尤其是用于降低血糖与血脂和治疗糖尿病的药物组合物。
背景技术:该组合物包括枸杞子、山茱萸、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、镁及微量元素锌、硒、铬、钼。
枸杞子是一种既是食品又是药品的天然中药材,有补益肝肾,滋阴补血,益精明目,润肺止咳的作用,为一味平补药物;古代中医将枸杞子列为中药之上品,其中《本草汇言》对之评价尤高,认为其兼具十几种中药之优点,称其:“使气可充,血可补,阳可生,阴可长,火可降,风湿可去”;临床主要用于肝肾两虚,精血不足之腰膝酸软,头晕目眩,须发早白,视力减退,性功能减退等症;现代药理研究证实枸杞子具有:1、降低血脂作用,枸杞子有明显抑制胆固醇升高并有轻微地对抗动脉粥样硬化的作用;2、降血糖和提高糖耐量的作用;3、清除体内有害自由基的作用;4、增强动物心、脑组织过氧化氢酶,乳酸脱氢酶的活性,可使老年人血中超氧化物歧化酶活性升高,过氧化脂质含量降低,可使造血干细胞增强,具有抗衰老和刺激动物生长发育的作用;5、保护肝脏作用;6、增强免疫和调解免疫的作用;7、抗癌抑瘤作用;8、保护生殖系统作用;9、抗突变作用;10、增进智能和改善记忆的功能;11、抗疲劳与抗高温作用等;枸杞子性味平和,对增进人体生理代谢机能具有许多有益的价值。
山茱萸是一种可做为保健食品的收涩类天然中药材,有补益肝肾,收敛固涩之功效;临床用于治疗肝肾亏损,眩晕,阳痿,滑精遗尿,虚汗,崩漏下血等病症;现代药理研究证实山茱萸具有:1、明显的降血糖作用,对胰岛素依赖性糖尿病有治疗作用;2、降血脂作用;3、抗氧化作用;4、抗衰老活性;5、抗应激,抗疲劳作用;6、增强免疫功能;7、抗失血性休克作用;8、抗血小板聚集,抗血栓形成作用;9、增强记忆力的作用;10、保护肝脏作用;11、此外还有抗炎,抗菌,在体外能杀死腹水癌细胞等作用。
维生素A也称视黄醇,有提高视力、防止夜盲的作用,参与糖原和蛋白质的合成,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,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,β-胡萝卜素具有与维生素E、维生素C以协同互补的方式抑制LDL胆固醇氧化反应的作用。
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B1参与体内蛋白质、脂肪、碳水化合物的分解代谢和合成代谢,缺乏时可致以脚气病为代表的各种代谢障碍,此外维生素B1还参与神经冲动反应,维持心肌正常功能,维持正常食欲,胃肠蠕动和消化液分泌等;维生素B2又名核黄素,是机体中许多重要辅酶的组成部分,参与体内的物质代谢,保证体内氧化还原反应和能量生成,参与体内抗氧化防御系统,缺乏时主要表现口腔生殖系统综合症、生长障碍、缺铁性贫血、湿性皮炎、减少红细胞生成、影响神经系统功能、降低视力等;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在体内起转氨酶、氨基酸脱羧酶的辅酶作用,保证氨基酸、糖原、脂肪酸及一碳单位、烟酸等物质的新陈代谢,保证核酸和蛋白质的合成与细胞的正常增殖,保证与一羟色胺、牛磺酸、多巴胺等神经递质的正常代谢,保证正常的免疫功能,缺乏时免疫力下降,还可造成神经系统的损害;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;
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,在胆固醇代谢中起重要作用,可有效降低中性脂肪,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;
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,具有抗氧化,避免生物膜发生脂质过氧化反应的作用;阻止低密度脂蛋白氧化形成的作用,从而防止动脉粥样硬化和心血管疾病的发生;此外还有调节免疫、延缓衰老、抑制肿瘤、促进胚胎发育和生殖能力及对神经和骨骼的保护作用等。
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;缺钙还会引起内分泌功能紊乱及细胞生长调节失灵。
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。
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。
铬是胰岛素的“协同激素”,以具有活性的含铬有机化合物“葡萄糖耐受因子(GTF)”形式增强胰岛素的作用,主要是维持机体正常的糖代谢及脂代谢,不足时会出现以下症状:削弱葡萄糖耐量、加重高血糖症、尿糖、低血糖症、加速胰岛素循环、减少胰岛素受体数量、降低胰岛素结合能力、体重减轻、增加脂肪含量、增加视觉压力等。环境中稳定存在两种价态的铬,即三价铬和六价铬,三价铬具有生理活性,在适量的范围内施用有益无害,六价铬是一种强氧化剂,对人体具有毒副作用。
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。
应用含有枸杞子、山茱萸、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、镁及微量元素锌、硒、铬、钼作为有效组分的组合物已为人所知,但将枸杞子、山茱萸、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、镁及微量元素锌、硒、铬、钼配伍用于降低血糖与血脂和治疗糖尿病的药物组合物尚未报道。
当前用于降低血糖与血脂的药品或保健品种类有多种,但是作用靶点少、环节欠缺,需要完善,并且有副作用的药品较多,加之成本和售价都很高。
发明内容:为了克服现有降低血糖与血脂和治疗糖尿病药物的缺点和不足,本发明的目的是提供一种组合物,该组合物通过枸杞子和山茱萸增加维生素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、镁及微量元素锌、硒、铬、钼降低血糖与血脂之功效,同时通过常量元素钙、镁和微量元素锌、硒、铬、钼及维生素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,补充和增强枸杞子和山茱萸降低血糖与血脂和治疗糖尿病的效果,即使长期施用也没有任何副作用;由于广泛研究的结果,本发明人发现了枸杞子、山茱萸、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、镁及微量元素锌、硒、铬、钼的新型组合,这一新型组合对于降低血糖与血脂和治疗糖尿病有协同效果;而单用枸杞子、山茱萸、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、镁及微量元素锌、硒、铬、钼,其效果均不及本组合物;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。
本发明提供了用于降低血糖、高血脂和治疗糖尿病的药物组合物,它包括作为有效组分的枸杞子、山茱萸、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、镁及微量元素锌、硒、铬、钼。
枸杞子为茄科落叶小灌木或小乔木枸杞Lycium chinense Mill的浆果供用;呈椭圆形纺锤状,干燥成品略被压扁,长1.5-2cm,直径4-8mm,橙红色至暗红色,味略甜;品种较多,以宁夏枸杞Lycium darbarum L.果大,质佳著称;分布于亚洲东部和欧洲,中国各地均有野生,以宁夏、甘肃、青海、内蒙古、陕西等地栽培较多;本发明所用枸杞子可用其提取物做为原料。
山茱萸为山茱萸科落叶灌木或乔木山茱萸Cornus officinalis Sieb.et Zucc.的成熟干燥果肉供用,主产河南、陕西、浙江、安徽、山西等地;本发明所用山茱萸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)、铬(Cr)、钼(Mo)为人体必需微量元素,钙(Ca)、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、乳酸钙、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、碳酸钙等,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、醋酸锌、碳酸锌、氧化锌、氯化锌、乳酸锌、硫酸锌、葡萄糖酸锌、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,微量元素铬可选用三氯化铬、烟酸铬、吡啶甲酸铬、铬酵母等三价铬,微量元素钼可选用钼酸铵、钼酸钠等,均有专业生产厂及供货商。
本发明的组合物主要适用于高血糖与高血脂和糖尿病人群,按本发明,枸杞子的有效用量以整体天然药材计为5000—15000mg/天,山茱萸的有效用量以整体天然药材计为6000—12000mg/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—150mgα-TE/天,常量元素钙的有效用量以元素钙计为250—1000mg/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,铬的有效用量以元素铬计为0.015—0.15mg/天,钼的有效用量以元素钼计为0.02—0.06mg/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,枸杞子、山茱萸、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、镁及微量元素锌、硒、铬、钼各组份可分别制剂,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、多靶点降低血糖与血脂和治疗糖尿病,各组份之间有协同发挥功效的作用,对降低血糖与血脂和治疗糖尿病有显著的效果,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。
附表1为本组合物与枸杞子加山茱萸组份和维生素加元素组份对四氧嘧啶致糖尿病模型小鼠降血糖试验效果比较。
附表2为本组合物与枸杞子加山茱萸组份和维生素加元素组份对(STZ)致糖尿病模型大鼠降血脂试验效果比较。
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:
枸杞子 8000mg,
山茱萸 7000mg,
维生素B1 3mg,
维生素B2 3mg,
维生素B6 2mg,
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,
吡啶甲酸铬(以微量元素铬计) 0.01mg,
钼酸纳(以微量元素钼计) 0.03mg,
乳酸镁(以元素镁计) 200mg,
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:
枸杞子 8700mg,
山茱萸 7500mg,
维生素B1 3mg,
维生素B2 3mg,
维生素B6 2mg,
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,
铬酵母(以微量元素铬计) 0.02mg,
钼酸纳(以微量元素钼计) 0.04mg,
乳酸钙(以元素钙计) 600mg,
乳酸镁(以元素镁计) 200mg,
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:
枸杞子 9000mg,
山茱萸 8000mg,
维生素B1 3mg,
维生素B2 3mg,
维生素B6 2mg,
叶酸 0.3mg,
维生素B12 0.003mg,
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,
铬酵母(以微量元素铬计) 0.02mg,
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,
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:
枸杞子 9500mg,
山茱萸 9000mg,
维生素B1 3mg,
维生素B2 3mg,
维生素B6 2mg,
叶酸 0.3mg,
维生素B12 0.003mg,
烟酰胺 10mg,
生物素 0.08mg,
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,
铬酵母(以微量元素铬计) 0.02mg,
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,
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:
枸杞子 9800mg,
山茱萸 9500mg,
维生素B1 3mg,
维生素B2 3mg,
维生素B6 2mg,
叶酸 0.3mg,
维生素B12 0.003mg,
烟酰胺 10mg,
泛酸 5mg,
生物素 0.06mg,
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,
铬酵母(以微量元素铬计) 0.02mg,
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,
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6:
枸杞子 5000mg,
山茱萸 6000mg,
维生素B1 0.5mg,
维生素B2 0.5mg,
维生素B6 0.5mg,
叶酸 0.1mg,
维生素B12 0.001mg,
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,
铬酵母(以微量元素铬计) 0.015mg,
钼酸钠(以微量元素钼计) 0.02mg,
乳酸钙(以元素钙计) 250mg,
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) 200μg RE,
维生素D 0.015mg,
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7:
枸杞子 15000mg,
山茱萸 12000mg,
维生素B1 20mg,
维生素B2 20mg,
维生素B6 10mg,
叶酸 1mg,
维生素B12 0.025mg,
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,
铬酵母(以微量元素铬计) 0.15mg,
钼酸钠(以微量元素钼计) 0.06mg,
乳酸钙(以元素钙计) 1000mg,
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10日,停服5日,再服10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。
实施例8:本组合物与各组份对四氧嘧啶致糖尿病模型小鼠降血糖试验效果比较。
选昆明种小鼠60只,雄雌各半;其中48只小鼠雄雌各半,禁食16小时后,尾静脉注射四氧嘧啶70mg/kg-1,72小时之后,测定空腹血糖值,血糖值高于16.7mmol/L-1者为高血糖小鼠,根据血糖水平将高血糖小鼠分为4组:模型对照组(B组),C组,D组,E组,试验各组按0.2mL/10g-1体重灌胃给药连续10天,第10天禁食7小时后灌胃给药,同法测定给药后1小时,2小时的血糖值;余下的12只小鼠,作为正常对照组(A组),模型对照组与正常对照组每天给等体积生理盐水灌胃一次。
相关数据见附表1。
附表1:本组合物与枸杞子加山茱萸组份和维生素加元素组份对四氧嘧啶致糖尿病模型小鼠降血糖试验效果比较:
实施例9:本组合物与各组份对(STZ)致糖尿病模型大鼠降血脂试验效果比较。
选SD系雄性大鼠48只进食高脂饲料,饲养4周后按25mg/kg体重一次腹腔内注射STZ(链尿佐菌素),于2周后禁食8小时后,按2g/kg体重灌服20%D-葡萄糖溶液,做口服糖耐量试验,凡0和2小时血糖分别大于7.0和11.0mmol/L的大鼠,作为糖尿病造模成功大鼠。将造模成功大鼠随机分为4组,每组12只,分别为对照组(A组),B组,C组,D组,试验各组每天经口给予被检物和等量的蒸馏水混悬液灌胃一次,对照组每天给予等量生理盐水灌胃一次,于给药12周后第3日禁食10小时,颈动脉采血,分别测定总胆固醇,甘油三脂,高密度脂蛋白,三项指标。
相关数据见附表2。
附表2:本组合物与枸杞子加山茱萸组份和维生素加元素组份对(STZ)致糖尿病模型大鼠降血脂试验效果比较:
从表1中可明显看出,服用本组合物制剂与服用枸杞子加山茱萸组份及维生素加元素组份对比糖尿病模型小鼠降血糖试验效果有非常显著的差异。
从表2中可明显看出,服用本组合物制剂与服用枸杞子加山茱萸组份及维生素加元素组份对比高血脂模型大鼠降血脂试验效果有非常显著的差异。
Claims (6)
1、一种用于降低血糖与血脂和治疗糖尿病的药物组合物,其特征是,它由下列原料按重量配比制成:
枸杞子 5000—15000mg,
山茱萸 6000—12000mg,
维生素B1 0.5—20mg,
维生素B2 0.5—20mg,
维生素B6 0.5—10mg,
叶酸 0—1mg,
维生素B12 0—0.025mg,
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,
铬 0.015—0.15mg,
钼 0.02—0.06mg,
钙 0—1000mg,
镁 100—300mg,
视黄醇当量[维生素A和/或β-胡萝卜素] 0—800μgRE,
维生素D 0—0.01mg,
维生素E 5—150mg a-TE。
2、根据权利要求1所述的用于降低血糖与血脂和治疗糖尿病的药物组合物,其特征是,它由下列原料按重量配比制成:
枸杞子 5000—15000mg,
山茱萸 6000—12000mg,
维生素B1 0.5—20mg,
维生素B2 0.5—20mg,
维生素B6 0.5—10mg,
叶酸 0—10mg,
维生素B12 0—0.025mg,
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,
铬 0.015—0.15mg,
钼 0.02—0.06mg,
钙 250—1000mg,
镁 100—300mg,
视黄醇当量[维生素A和/或β-胡萝卜素] 0—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所述的用于降低血糖与血脂和治疗糖尿病的药物组合物,其特征是,它由下列原料按重量配比制成:
枸杞子 5000—15000mg,
山茱萸 6000—12000mg,
维生素B1 0.5—20mg,
维生素B2 0.5—20mg,
维生素B6 0.5—10mg,
叶酸 0.1—1mg,
维生素B12 0.001—0.025mg,
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,
铬 0.015—0.15mg,
钼 0.02—0.06mg,
钙 250—1000mg,
镁 100—300mg,
视黄醇当量[维生素A/或β-胡萝卜素] 0—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所述的用于降低血糖与血脂和治疗糖尿病的药物组合物,其特征是,它由下列原料按重量配比制成:
枸杞子 5000—15000mg,
山茱萸 6000—12000mg,
维生素B1 0.5—20mg,
维生素B2 0.5—20mg,
维生素B6 0.5—10mg,
叶酸 0.1—1mg,
维生素B12 0.001—0.025mg,
烟酰胺 5—50mg,
泛酸 0—20mg,
生物素 0.01—0.1mg,
维生素C 30—500mg,
锌 5—20mg,
硒 0.015—0.1mg,
铬 0.015—0.15mg,
钼 0.02—0.06mg,
钙 250—1000mg,
镁 100—300mg,
视黄醇当量[维生素A和/或β-胡萝卜素] 0—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所述的用于降低血糖与血脂和治疗糖尿病的药物组合物,其特征是,它由下列原料按重量配比制成:
枸杞子 5000—15000mg,
山茱萸 6000—12000mg,
维生素B1 0.520mg,
维生素B2 0.5—20mg,
维生素B6 0.5—10mg,
叶酸 0.1—1mg,
维生素B12 0.001—0.025mg,
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,
铬 0.015—0.15mg,
钼 0.02—0.06mg,
钙 250—1000mg,
镁 100—300mg,
视黄醇当量[维生素A和/或β-胡萝卜素] 0—800μgRE,
维生素D 0.0015—0.01mg,
维生素E 5—150mg a-TE。
6、根据权利要求1所述的用于降低血糖与血脂的和治疗糖尿病药物组合物,其特征是,它由下列原料按重量配比制成:
枸杞子 5000—15000mg,
山茱萸 6000—12000mg,
维生素B1 0.5—20mg,
维生素B2 0.5—20mg,
维生素B6 0.5—10mg,
叶酸 0.1—1mg,
维生素B12 0.001—0.025mg,
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,
铬 0.015—0.15mg,
钼 0.02—0.06mg,
钙 250—1000mg,
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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