CN106974292B - 一种由维生素d、e及叶酸组成的维生素组合物保健食品 - Google Patents
一种由维生素d、e及叶酸组成的维生素组合物保健食品 Download PDFInfo
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Abstract
本发明公开了一种维生素组合物保健食品，可用于促进中老年心脑血管系统的健康，该保健食品由维生素D、维生素E、叶酸及适量辅料组成，其中维生素D含量为2～100μg、维生素E含量为20～500mg、叶酸含量为100～2000μg。本发明的优点是：精选功能相关维生素，针对这些维生素易缺乏的人群，实施精准营养补充，各成份间具有功效协同作用。
Description
技术领域
本发明涉及一种维生素组合物保健食品，更准确地说，本发明涉及一种对维生素D、E及叶酸缺乏人群实施精准营养、促进心脑血管系统健康的保健食品。
背景技术
随着我国社会经济的发展，人口老龄化加剧，伴随出现的是老年病的日渐增多，特别是在心脑血管领域形势更为严峻。维生素D受体存在于身体大部分组织中，许多常见病包括一些常见肿瘤、糖尿病、老年痴呆、心血管疾病和骨质疏松症都与维生素D缺乏有关，维生素D缺乏已成为公共卫生问题；维生素E是一种天然抗氧化剂，通过自身被氧化，阻断过氧化连锁反应，抑制脂质过氧化，从而保护细胞膜磷脂和血浆脂蛋白等免受自由基攻击，保证细胞膜结构和功能完整性，缓解氧化应激。维生素E还可以激发免疫系统功能，发挥免疫功能，延缓机体细胞老化，改善血液循环、降低胆固醇、预防高血压。维生素E对于衰老进程也能发挥重要作用。跟欧美国家相比，我国没有强制规定在面粉或谷物里添加叶酸，因种族原因导致我国人群中亚甲基四氢叶酸还原酶(MTHFR)基因突变的概率大大高于欧美国家，加之传统的高温烹调的饮食习惯，导致正常饮食中叶酸摄入量不足、继而血液同型半胱氨酸(Hcy)水平升高，而新近医学研究发现Hcy是一个心血管危险因子。目前市场上复合维生素产品众多，但因成分多、每种元素含量较低，缺乏针对性，实际营养效果尚难预料。本发明通过研究，精选功能相关维生素，开发一种辅助促进中老年人心脑血管系统健康的保健食品，是对现有维生素产品的显著改进。
发明内容
本发明的目的在于提供一种辅助促进中老年人心脑血管系统健康的维生素组合物保健食品。
为了实现上述目的，本发明采用以下技术方案：
一种辅助促进中老年人心脑血管系统健康的维生素组合物保健食品，由以下成分组成：
(1)维生素D
(2)维生素E
(3)叶酸
(4)辅料。
在上述保健食品中，维生素D含量为2～100μg；维生素E的含量为20～500mg；叶酸为100～2000μg。
优选地，本发明所述的保健食品，维生素D含量为2～20μg；维生素E含量为20～150mg；叶酸含量为200～1200μg。
本发明中，所述的维生素D包括维生素D2和维生素D3。
本发明所述维生素E包括天然维生素E(D-α-生育酚、D-α-醋酸生育酚、D-α-琥珀酸生育酚)、dl-α-醋酸生育酚、dl-α-生育酚、维生素E琥珀酸钙等形式，其中α-生育酚是自然界中分布最广泛含量最丰富、活性最高的维生素E形式。
本发明所述叶酸类物质包括叶酸、5-甲基四氢叶酸、甲酰四氢叶酸钙、L-甲基叶酸、叶酸盐、叶酸或叶酸盐的活性代谢物和可在体内释放/生成叶酸的物质，即包括人工合成及植物提取物来源的各种叶酸形式。其中，5-甲基四氢叶酸尤其适用于MTHFR 677TT基因型人群。
本发明所述的保健食品可制成普通片剂、丸剂、冲剂、口服液、咀嚼片剂、软胶囊剂、硬胶囊剂、粉剂及颗粒剂等口服剂型。
本发明中所述的辅料选自填充剂、润湿剂、粘合剂、崩解剂、润滑剂、矫味剂、稳定剂、包埋物、包衣预混剂、食用色素中的一种或几种组合。
本发明所述的填充剂包括淀粉、可溶性淀粉、糊精、麦芽糊精、马铃薯淀粉、玉米淀粉、小麦淀粉、D-甘露糖醇、磷酸氢钙、无水磷酸氢钙、麦芽糖、木糖醇、山梨糖醇、微晶纤维素、异麦芽酮糖、乳粉、低取代羟丙纤维素、蔗糖、葡萄糖、乳糖、预胶化淀粉等的一种或几种。
本发明所述的润湿剂包括纯化水和乙醇，所述的粘合剂包括羟丙基甲基纤维素、聚维酮、羟丙纤维素、羧甲纤维素钠、淀粉、甲基纤维素、乙基纤维素、明胶、聚乙二醇、预胶化淀粉、蔗糖、葡萄糖等其中一种或几种。
本发明所述的崩解剂包括淀粉、羧甲淀粉钠、交联聚维酮、交联羧甲纤维素钠、低取代羟丙纤维素、碳酸氢钠与枸橼酸等其中的一种或几种，所述的润滑剂包括硬脂酸镁、硬脂酸、滑石粉、二氧化硅、氢化植物油、聚乙二醇、十二烷基硫酸钠、山嵛酸甘油酯、硬脂富马酸钠等其中的一种或几种。
本发明所述的矫味剂包括水果粉、食用香精、高倍甜味剂、酸味剂等其中的一种或几种，所述的水果粉包括橙粉、柠檬粉、樱桃粉、苹果粉、草莓粉、草莓粉、猕猴桃粉、橘粉、沙棘果粉、青梅果粉、芒果果粉、桑葚果粉、山楂果粉、西瓜果粉、菠萝果粉、蓝莓果粉、水蜜桃果粉、哈密瓜果粉、葡萄果粉、香草果粉、石榴果粉、玫瑰果粉等其中的一种或几种。
本发明所述的食用香精包括香草香精、甜橙香精、牛奶香精、苹果香精、葡萄香精、草莓香精、菠萝香精、水蜜桃香精、哈密瓜香精、柠檬香精、樱桃香精、甜玉米香精、香蕉香精、提子香精、玫瑰香精、黑加仑香精、青苹果香精、芒果香精、青芒果香精、桔子香精、香橙香精、雪梨香精、青梅香精、蓝莓香精、杨梅香精、柚子香精、菠萝香精、番石榴香精、百香果香精、奇异果香精、猕猴桃香精、西瓜香精、木瓜香精、榴莲香精、荔枝香精、山楂香精、橄榄香精、桑葚香精等其中的一种或几种。
本发明所述的高倍甜味剂包括三氯蔗糖、阿斯巴甜、罗汉果甜苷、纽甜、甜菊苷，所述的酸味剂包括柠檬酸、苹果酸、乳酸、酒石酸和富马酸，所述的食用色素包括焦糖色、栀子黄、姜黄色素和叶绿素、辣椒橙、辣椒红、葡萄皮红、胭脂红及其铝色淀、日落黄及其铝色淀、亮蓝及其铝色淀、靛蓝及其铝色淀、甜菜红、天然苋菜红、栀子蓝、植物炭黑、氧化铁黑、氧化铁红、黑豆红、喹啉黄、番茄红素、红曲红、黄氧化铁、可可壳色、红花黄、红曲黄色素等的一种或几种。
本发明所述的稳定剂包括维生素E、二丁基羟基甲苯(BHT)、丁基羟基茴香醚(BHA)、维生素C，所述的包埋物包括β-环糊精、α-环糊精、γ-环糊精、糊精、淀粉、食用变性淀粉、蔗糖、麦芽糊精、阿拉伯树胶等其中的一种或几种。
维生素D是一种脂溶性维生素，为固醇类衍生物，有五种化合物，与健康关系较密切的是维生素D2和D3，存在于部分天然食物中，受紫外线照射后人体内的胆固醇可转化为维生素D。维生素D受体存在于身体大部分组织中，许多常见病包括一些常见肿瘤、糖尿病、老年痴呆、心血管疾病和骨质疏松症都与维生素D缺乏有关。维生素D缺乏已成为公共卫生问题。
维生素E又名抗不育维生素，是一组在化学结构上与生育酚生物活性相似的衍生物总称。生育酚是母育酚的衍生物，这种衍生物的色满核是甲基化的。因甲基的数目和位置的不同，而分为α-、β-、γ-、δ-生育酚。维生素E的生理学功能主要是作为自由基清除剂。暴露于各种环境因素的许多细胞酶系统、线粒体电子传递都可能生成氧类自由基和其它自由基，维生素E因其脂溶性而在自由基去毒防御系统中直接保护细胞膜，防止自由基或氧化剂对细胞膜中多不饱和脂肪酸、膜的富含疏基的蛋白质成分以及细胞骨架和核酸的损伤。
叶酸是人体在利用糖分和氨基酸时的必要物质，是机体细胞生长和繁殖所必需的物质，人体缺少叶酸可导致巨幼红细胞性贫血。此外，叶酸经二氢叶酸还原酶及维生素B12的催化作用后形成四氢叶酸，传递一碳单位，参与体内很多重要反应及核酸合成等，其中包括提供-CH3使Hcy再甲基化，从而促进Hcy的代谢转换，缓解高Hcy血症。从目前的文献资料和我们多年积累的研究结果来看，叶酸是对抗Hcy升高的最有效干预手段。
本发明所述的保健食品筛选功能协同的维生素进行科学组方，实施精准营养，确保产品功效。通过补充合适剂量维生素D、维生素E和叶酸，特别是针对容易缺乏这三种维生素的中老年人，可以起到抗氧化、保护血管内皮、促进心血管系统健康的作用，并对心血管危险因素有辅助抑制作用。本发明所述的保健食品的作用效果显著强于组成成分的单独或联用的应用效果。与现有产品相比，本品是一种保健效果更佳、更精准的营养补充产品。
下面结合实施例对本发明的实施方式作进一步描述，实施例中所列活性维生素的量均以有效成分计。
具体实施方式
实施例1.本发明所述保健食品的片剂制备(1000片量)
处方
制备工艺：取聚维酮K30用50％乙醇溶液配制成粘合剂，再将维生素E加入粘合剂中搅拌均匀，备用。另取维生素D、叶酸、三氯蔗糖与预胶化淀粉混合、过筛，再加入牛奶香精、羧甲淀粉钠、糊精混合，加入配制好的含有维生素E粘合剂制软材，24目筛制粒，55℃干燥2h，24目筛整粒，加入硬脂酸镁混合，压片。将包衣预混剂配制成溶液，素片包衣，即制得本发明所述保健食品的片剂。
实施例2.本发明所述保健食品的片剂制备(1000片量)
处方
制备工艺：取聚维酮K30用50％乙醇溶液配制成粘合剂，再将维生素E加入粘合剂中搅拌均匀，备用。另取维生素D、叶酸、三氯蔗糖与预胶化淀粉混合、过筛，再加入牛奶香精、羧甲淀粉钠、糊精混合，加入配制好的含有维生素E粘合剂制软材，24目筛制粒，55℃干燥2h，24目筛整粒，加入硬脂酸镁混合，压片。将包衣预混剂配制成溶液，素片包衣，即制得本发明所述保健食品的片剂。
实施例3.本发明所述保健食品的软胶囊制备(1000粒量)
处方
制备工艺：将蜂蜡加入大豆油中，50℃加热，使蜂蜡溶解，放置至室温，取维生素E、叶酸、维生素D加入大豆油中制成混悬液，备用。另取明胶、纯化水、焦糖色、对羟基苯甲酸酯配制成胶液，将制得的混悬物用压丸机压丸制成软胶囊，经定型，洗丸和干燥处理后，即制得本发明所述的保健食品的软胶囊剂。
为了证明本发明保健品的抗氧化、内皮保护功效，我们设计了以下实验，主要是对实验动物血清中超氧化物歧化酶(SOD)、还原性谷胱甘肽(GSH)、内皮素(ET-1)及一氧化氮(NO)的含量，考察本发明保健品的功效作用。
实验方法：将60只28-～35g 12-13月龄老年昆明小鼠随机分组，分别为老年对照组、服用保健品(实施例3中胶囊内容物)低剂量组、中剂量组、高剂量组、维生素E组，每组12只，分笼饲养，自由饮水饮食。其中，除老年对照组每日灌胃相应体积溶媒，低剂量组维生素E+叶酸+维生素D(7.5+0.025+0.00075)mg/kg/d灌胃给予本保健品，中剂量组维生素E+叶酸+维生素D(15+0.05+0.0015)mg/kg/d灌胃给予本保健品，高剂量组维生素E+叶酸+维生素D(30+0.1+0.003)mg/kg/d灌胃给予本保健品，维生素E组(15)mg/kg/d灌胃，持续8周。处死前12小时禁食不禁水。取小鼠腹主动脉血，静置4h后，离心取上清冷冻备用。分别对小鼠血清SOD、GSH的含量进行测定。
实验结果：
表1小鼠血清SOD及GSH测定结果
与老年对照组比较，#P<0.05，##P<0.01，组合物组与维生素E组比较，*P<0.05，**P<0.01
由表可以看出，与对照组相比，服用3种维生素保健品组血清SOD及GSH水平显著升高，表明机体抗氧化能力增强；与单独的维生素E组比较，保健品组合物组抗氧化能力进一步显著增强。
实施例4.本发明所述保健食品的软胶囊制备(1000粒量)
处方
制备工艺：将蜂蜡加入大豆油中，50℃加热，使蜂蜡溶解，放置至室温，取维生素E、叶酸、维生素D加入大豆油中制成混悬液，备用。另取明胶、纯化水、焦糖色、对羟基苯甲酸酯配制成胶液，将制得的混悬物用压丸机压丸制成软胶囊，经定型，洗丸和干燥处理后，即制得本发明所述的保健食品的软胶囊剂。
实施例5.本发明所述保健食品的软胶囊制备(1000粒量)
处方
制备工艺：将蜂蜡加入大豆油中，50℃加热，使蜂蜡溶解，放置至室温，取维生素E、叶酸、维生素D加入大豆油中制成混悬液，备用。另取明胶、纯化水、焦糖色、对羟基苯甲酸酯配制成胶液，将制得的混悬物用压丸机压丸制成软胶囊，经定型，洗丸和干燥处理后，即制得本发明所述的保健食品的软胶囊剂。
实施例6.本发明所述保健食品的咀嚼片制备(1000片)
处方
制备工艺：取羟丙甲纤维素E5用60％乙醇溶液配制成粘合剂，再将维生素E加入粘合剂中搅拌均匀，备用。另取维生素D、叶酸与微晶纤维素混合、过筛，再加入甜菊苷、柠檬香精、奶粉、木糖醇混合，加入配制好的含有维生素E粘合剂制软材，24目筛制粒，55℃干燥2h，24目筛整粒，加入硬脂酸镁混合，压片即制得本发明所述保健食品的咀嚼片。
为了证明本发明保健品对心血管系统疾病有一定的保护功效，我们设计了以下实验，主要是对实验动物血清中总胆固醇(TC)、低密度脂蛋白(LDL)，血管内皮保护功能的指标HCY、内皮素(ET-1)及一氧化氮(NO)的含量进行测定，并在实验过程中监测实验动物血压以考察本发明保健品的功效作用。
实验方法：将48只12～13周龄雄性SHR大鼠随机分组，分为模型组、服用保健品(实施例6)低剂量组、高剂量组，叶酸组，每组12只，另外有12只周龄相近的WKY大鼠作为空白对照组，分笼饲养，自由饮水饮食。其中，除WKY组喂饲普通饲料，其余组均喂饲高脂高蛋氨酸饲料，持续4周后，模型组及WKY组每日灌胃相应体积溶媒，低剂量组维生素E+叶酸+维生素D(25+0.4+0.015)mg/kg/d灌胃给予本保健品，高剂量组维生素E+叶酸+维生素D(50+0.8+0.03)mg/kg/d灌胃给予本保健品，叶酸组0.8mg/kg/d，持续6周，同时测定灌胃前血压(0w)、处死前血压(6w)，处死前12小时禁食不禁水。取大鼠腹主动脉血，静置4h后，离心取上清冷冻备用。分别对血清中总胆固醇TC、LDL及HCY的含量进行测定。
实验结果：
表2大鼠ET-1和NO测定结果
模型组与空白对照组比较，#P<0.05，##P<0.01；与模型组比较，*P<0.05，**P<0.01；组合物与叶酸组比较，&P<0.05，&P<0.01
表3大鼠血压测定结果
模型组与空白对照组比较，#P<0.05，##P<0.01；与模型组比较，*P<0.05，**P<0.01；组合物与叶酸组比较，&P<0.05，&P<0.01
表4大鼠血清TC、LDL及HCY测定结果
模型组与空白对照组比较，#P<0.05，##P<0.01；与模型组比较，*P<0.05，**P<0.01；组合物与叶酸组比较，&P<0.05，&P<0.01
由表2～4可以看出，与模型组相比，血清ET-1水平降低、NO水平增高，表明内皮损伤程度较模型组有较明显改善，这与已知的叶酸的内皮保护功能结论相一致。模型组血清TC、LDL及HCY值均明显升高，服用保健品高剂量组血清TC、LDL及HCY水平均明显降低，且低剂量组均有一定的降脂作用，未达到显著性差异。同时灌胃6w后服用保健品组动物平均血压低于未服用组，有一定的降压幅度，但降压效果不显著，给保健品组有5～15mmHg的降压效果。
总体上，该保健品对心血管疾病危险因素血压、血脂和HCY、NO，ET-1水平有不同程度的改善作用，进一步验证了本发明保健品的功效作用。
另外安全性毒理学试验表明本保健品安全无毒副作用。
实施例7.本发明所述保健食品的颗粒剂制备(1000袋量)
处方
制备工艺：将蔗糖粉碎过100目筛备用；取聚维酮K30用50％乙醇溶液配制成粘合剂，再将维生素E加入粘合剂中搅拌均匀，备用。另取维生素D、叶酸与蔗糖混合、过筛，再加入苹果粉、苹果香精、羧甲淀粉钠、麦芽糊精混合，加入配制好的含有维生素E粘合剂制软材，24目筛制粒，55℃干燥2h，24目筛整粒，即制得本发明所述保健食品的颗粒剂。
实施例8.本发明所述保健食品的粉剂制备(1000袋量)
处方
制备工艺：将上述各组分置于混合机中混合均匀，然后用分装机进行分装，即制得本发明所述保健食品的粉剂。
实施例9：本发明所述保健食品的咀嚼片制备(1000片量)
配方：
制备工艺：取羟丙甲纤维素E5用60％乙醇溶液配制成粘合剂，再将维生素D加入粘合剂中搅拌均匀，备用。另取维生素E(生育酚)、叶酸与微晶纤维素混合、过筛，再加入甜菊苷、柠檬香精、奶粉、木糖醇混合，加入配制好的含有维生素D粘合剂制软材，24目筛制粒，55℃干燥2h，24目筛整粒，加入硬脂酸镁混合，压片即制得本发明所述保健食品的咀嚼片。
Claims (7)
1.一种辅助预防中老年人心脑血管系统疾病的维生素组合物保健食品，其特征在于：由20～500mg维生素E、100～2000μg叶酸、2～100μg维生素D及保健食品可接受的辅料组成。
2.根据权利要求1所述的保健食品，其特征在于：所述维生素D含量为2～20μg；所述维生素E含量为20～150mg；所述叶酸含量为200～1200μg。
3.根据权利要求1所述的保健食品，其特征在于：所述的维生素D选自维生素D2和D3。
4.根据权利要求1所述的保健食品，其特征在于：所述维生素E是D-α-生育酚、D-α-醋酸生育酚、D-α-琥珀酸生育酚、dl-α-醋酸生育酚、dl-α-生育酚或维生素E琥珀酸钙。
5.根据权利要求1所述的保健食品，其特征在于：所述叶酸是合成叶酸、5-甲基四氢叶酸、甲酰四氢叶酸钙或L-甲基叶酸。
6.根据权利要求1～5任一项所述的保健食品，其特征在于：所述的保健食品可制备成普通片剂、丸剂、冲剂、口服液、咀嚼片剂、软胶囊剂、硬胶囊剂、粉剂及颗粒剂。
7.权利要求1～6任一项所述的维生素组合物保健食品在制备辅助预防中老年人心脑血管系统疾病或促进中老年人心脑血管系统健康的保健食品中的用途。
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