CN106798337B - 一种适用于中老年人的营养补充剂 - Google Patents
一种适用于中老年人的营养补充剂 Download PDFInfo
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- CN106798337B CN106798337B CN201710032803.9A CN201710032803A CN106798337B CN 106798337 B CN106798337 B CN 106798337B CN 201710032803 A CN201710032803 A CN 201710032803A CN 106798337 B CN106798337 B CN 106798337B
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Abstract
本发明公开了一种对中老年人骨骼健康有辅助保护作用、对心脑血管疾病有预防作用的保健食品，该保健食品由维生素D 2～100μg、叶酸100～1000μg、维生素B125～50μg及适量辅料组成。本发明所述的保健食品精选功能确切的维生素进行科学组方，针对特定人群，各成分间具有功能协同作用，从而体现本产品的精准营养与保健特性。
Description
技术领域
本发明涉及一种保健食品，更准确地说，本发明涉及一种对中老年人骨胳、心脑血管系统有辅助健康促进作用的保健食品。
背景技术
中老年人的骨质疏松问题相当严重。骨质疏松症(osteoporosis，OP)是一种以骨量低下、骨微结构破坏、骨脆性增加、易发生骨折为特征的全身性骨病。中老年人是骨质疏松的高发人群，据统计，全球骨质疏松的患者大约有2亿，年龄超过50岁的人群中50％女性和20％男性会出现骨质疏松。我国社会老龄化进程加快，老年人的比例越来越高，骨质疏松症的发病率亦将呈上升趋势。骨质疏松可导致疼痛、骨折、骨骼变形等问题，威胁老年人的健康和生活质量，髋部骨折作为骨质疏松的最严重后果，甚至可以引起患者死亡。
同型半胱氨酸(homocysteine，Hcy)是一种含硫氨基酸，是蛋氨酸代谢过程的中间产物。研究发现，高Hcy血症不仅是心血管疾病的危险因素(致病机制包括损伤血管内皮、促进血管平滑肌细胞增殖及动脉硬化等)，同时也是骨质疏松性骨折的一个危险因素。高Hcy血症可妨碍胶原蛋白纤维与组织的连接，从而促进骨质疏松症发生，据推算19％老年性骨折与高Hcy水平有关。人体血Hcy水平取决于遗传、饮食等因素，叶酸摄入不足可以使血Hcy升高，维生素B12是Hcy代谢的辅助因子，如果缺乏则同样会促使高Hcy血症形成。
目前市场上复合维生素产品众多，多为营养补充剂，各类人群皆可服用，但由于成分多、每种元素含量较低，缺乏针对性，实际保健效果尚难预料。因此，本发明旨在开发一种辅助保护老年人骨骼健康、预防心脑血管疾病的保健食品，是对现有市场多种维生素产品的优化，符合精准营养的趋势。
发明内容
本发明的目的在于提供一种对中老年人骨骼有辅助保护作用、对心脑血管疾病有预防作用的保健食品。
为了实现上述目的，本发明采用以下技术方案：
一种对中老年人骨骼有辅助保护作用、对心脑血管疾病有预防作用的保健食品，由以下成分组成：
(1)维生素D
(2)叶酸
(3)维生素B12
(4)辅料。
在上述保健食品中，维生素D含量为2～100μg，叶酸含量为100～1000μg，维生素B12含量为5～50μg。
优选地，本发明所述的保健食品，维生素D含量为2～20μg，叶酸含量为400～800μg，维生素B12含量为5～20μg。
本发明中，所述的维生素D包括维生素D2和维生素D3。
本发明中，所述的叶酸包括叶酸、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。
本发明所述维生素B12包括钴胺素、甲钴胺素、5’-脱氧腺苷钴胺素、羟钴胺素、氰钴胺素及其他钴胺素的衍生物和可在体内释放/生成钴胺素的物质。
本发明所述的保健食品可制成普通片剂、咀嚼片剂、软胶囊剂、硬胶囊剂、粉剂及颗粒剂等口服剂型。
在本发明中，所述的辅料选自填充剂(分散剂)、助悬剂、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。
其中，本发明所述的填充剂(分散剂)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、食用植物油、聚乙二醇等的一种或几种。
本发明所述的助悬剂包括蜂蜡、虫蜡、卵磷脂、单硬脂酸甘油酯、乙基纤维素等其中的一种或几种，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、葡萄香精、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、草莓香精、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、樱桃香精、猕猴桃香精、西瓜香精、木瓜香精、哈密瓜香精、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、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。
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，从而确保产品的功效，通过补充最佳剂量维生素D、叶酸、维生素B12(中老年人易缺乏的维生素)，辅助防治中老年人骨质疏松症，兼可以辅助预防心血管疾病，协同促进这一人群骨骼系统和心血管系统的健康。
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D是维持骨骼健康必不可少物质之一，促进钙磷吸收、骨基质钙化，使骨质坚硬，亦刺激成骨细胞中的骨桥蛋白和碱性磷酸酶合成，抑制成骨细胞凋亡，有利骨形成。维生素D缺乏可导致儿童生长迟缓、骨骼畸形，即儿童佝偻病，补充维生素D则可预防或治疗佝偻病，故维生素D又称抗佝偻病维生素。维生素D缺乏导致或加剧成人骨量减少和骨质疏松症，甚至引起骨软化和肌无力，增加骨折风险。
叶酸属于B族维生素，为机体细胞生长和繁殖的必需物质。叶酸经二氢叶酸还原酶及维生素B12的催化后形成四氢叶酸，后者与多种一碳单位(包括-CH3、-CH2、-CHO等)结合成四氢叶酸类辅酶，传递一碳单位，参与体内很多重要反应。叶酸缺乏可导致脱氧核糖核酸(DNA)合成障碍，进而细胞分裂、繁殖受阻。亚甲基四氢叶酸还原酶(MTHFR)基因多态性可能导致我国人群对叶酸利用能力的相对不足：MTHFR是5,10-亚甲基四氢叶酸还原为5-甲基四氢叶酸的关键酶,如基因突变则使酶活性显著下降，影响外源性叶酸活化为5-甲基四氢叶酸，一碳单位传递受阻，则Hcy不能顺利转化为蛋氨酸，形成高Hcy血症。MTHFR C677T有三种基因型，即纯合野生型(CC)、杂合型(CT)和纯合突变型(TT)，TT型酶活性只有CC型30％。我国人群TT基因型频率平均23.2％，显著高于欧美国家，加之高温烹调蔬菜的习惯，叶酸缺乏率(65％)明显高于欧美国家。
维生素B12以辅酶的形式存在，是Hcy转化为蛋氨酸的关键辅助因子，可以增强叶酸的利用率，故常与后者协同降低血Hcy水平。如果人体长期缺乏维生素B12，与缺乏叶酸的结果相类似，会导致Hcy在体内蓄积。研究显示，高Hcy血症是脑卒中的独立危险因素，可显著增加高血压患者发生心血管事件的风险，且血浆Hcy水平升高也使破骨细胞的数量和活性增加，促进骨吸收，从而增加骨质疏松的风险。
总之，适量针对性补充维生素D、叶酸和维生素B12，不仅促进钙磷吸收，促进骨基质钙化，使骨质坚硬，还可使血浆Hcy水平降低，保护血管内皮，增加骨密度，三者共同发挥对中老年人骨质疏松症和心血管疾病的预防作用以及对这一人群骨骼、心血管系统的保健作用。
与现有产品相比，本发明所述的产品是一种效果更佳、更精准的维生素功能保健食品，下面结合实施例对本发明的实施方式作进一步描述。
附图说明
图1是本发明所述保健食品湿法制粒工艺流程图；
图2是本发明所述保健食品直压工艺路线图；
图3是本发明所述保健食品包埋+直压工艺路线图。
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)
配方：
制备方法：取聚维酮K30用50％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B12、5-甲基四氢叶酸、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。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。
为了证明本发明保健品有预防心脑血管疾病的作用，我们设计了以下实验，主要是对实验动物Hcy及血管内皮因子ET-1和NO的水平，考察本发明保健品的功效作用。
取本实施例1制得的药物组合物，进行安全性毒理学评价和药效学试验。
急性毒性：取本实施例1所制胶囊内容物，按剂量5g/kg给予20只大鼠(雌雄各半)，按照40mL/kg的体积灌胃给予，给药1次，连续观察14天，SD大鼠一般状况未见异常，实验结果表明该组合物对SD大鼠的最大耐受量大于5g/kg。
本发明保健品降低Hcy，保护血管内皮的药效学研究：
实验动物：雄性SD大鼠，SPF级，6周龄，体重在200g±20g,购自广东省医学实验动物中心，许可证号SCX(粤)2013-0002。
饲料：正常对照组(C)喂饲饲料采用标准AIN93M配方纯化饲料，其他试验组饲料均在AIN93M基础上制备的叶酸和B12缺乏纯化饲料。
实验方法：50只雄性SD大鼠适应性饲养一周后，按照体重随机选取10只喂饲标准AIN93M纯化饲料作为正常对照组，其余动物喂饲叶酸和B12缺乏的纯化模型饲料4周后，采血检测Hcy。根据Hcy水平，将模型动物随机分成4组，继续叶酸和B12缺乏饲料喂养,一组作为模型组，另三组分别为保健品高中低剂量组，也继续喂饲叶酸和B12缺乏饲料，(以有效物质质量计)灌胃给药，连续给药8周，眼眶采血，检测大鼠Hcy水平、ET-1及NO水平。
统计分析：试验数据采用GraphPad Prism 5统计分析软件进行统计处理；数据结果均以
表示。组间比较采用ANOVA检验，设定检验水准为α＝0.05，P<0.05有统计学差异，P>0.05无统计学差异。
实验结果：见表1。结果表明，本发明维生素保健品具有显著降低大鼠血Hcy作用，并能够显著提高NO水平、降低ET-1水平，显示良好的降Hcy、血管保护作用。
表1.本发明保健食品对大鼠的降Hcy、血管保护作用
与对照组比较，*P<0.05，**P<0.01；与对模型组比较，#P<0.05，##P<0.01
实施例2：本发明所述保健食品的软胶囊制备(1000粒量)
配方：
制备方法：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D、5-甲基四氢叶酸、维生素B12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3：本发明所述保健食品的硬胶囊剂制备(1000粒量)
配方：
制备方法：将5-甲基四氢叶酸与20％微晶纤维素混合，过筛，再加入维生素D干粉、维生素B12混合，将所得的原料混合物与剩余量的微晶纤维素等量递增混合，再加入乳糖、硬脂酸镁混合，然后采用全自动胶囊填充机进行填充，经抛光处理后即制得本发明所述保健食品的硬胶囊剂。
实施例4：本发明所述保健食品的颗粒剂制备(1000份量)
配方：
制备方法：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D加入粘合剂中搅拌均匀，备用。另取维生素B12、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D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5：本发明所述保健食品的咀嚼片制备(1000片量)
配方：
制备方法：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B12、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。
为了证明本发明保健品对骨质疏松的治疗和预防功效，我们设计了以下实验，主要是对实验动物股骨干重(WB)、右股骨密度(BMDF)及L2～L4骨密度(BMDL)的含量，考察本发明保健品(实施例5所制)的功效作用。
实验方法：雌性SD大鼠48只，12月龄(老年)，体重(420±20)g；雌性SD大鼠12只，5月龄(青年)，体重(400±20)g。老年雌性SD大鼠48只随机分为4组：老年大鼠组、低剂量组维生素D+叶酸+维生素B12(2+80+2)μg/kg/d，中剂量组维生素D+叶酸+维生素B12(4+160+4)μg/kg/d、高剂量组维生素D+叶酸+维生素B12(8+320+8)μg/kg/d，每组12只，另取12只青年雌性大鼠作为青年对照组。青年对照组和老年模型组每日灌胃相应体积溶媒，6周后颈椎脱臼处死动物，剥离双侧股骨、胫骨和腰椎(L2-4)仔细剔除结缔组织，进行相关指标测定。
统计分析：试验数据采用GraphPad Prism 5统计分析软件进行统计处理；数据结果均以
表示。组间比较采用ANOVA检验，设定检验水准为α＝0.05，P<0.05有统计学差异，P>0.05无统计学差异。
实验结果：见表2。
表2.本发明保健品对大鼠股骨质量、密度及椎骨密度的影响
与青年对照组比较，*P<0.05，**P<0.01；与对老年组比较，#P<0.05，##P<0.01
结果显示，高中低剂量的保健品均可使老年雌性大鼠的骨重及松质骨密度得到明显改善，且有一定的量效关系。
另外，安全性毒理学试验表明本保健品安全、无毒副作用。
Claims (8)
1.一种对中老年人骨骼健康有辅助保护作用的保健食品，由维生素D、叶酸、维生素B12及可接受的辅料组成，其特征在于：维生素D含量为2～20μg，叶酸含量为400～800μg，维生素B12含量5～20μg。
2.根据权利要求1所述的保健食品，其特征在于：所述的叶酸是合成叶酸、5-甲基四氢叶酸、甲酰四氢叶酸、亚叶酸或左亚叶酸钙。
3.根据权利要求1或2所述的保健食品，其特征在于：所述维生素B12是甲钴胺素、5’-脱氧腺苷钴胺素、羟钴胺素、氰钴胺素或其他可在体内释放/生成钴胺素的物质。
4.根据权利要求1或2所述的保健食品，其特征在于：所述维生素D选自维生素D2和维生素D3。
5.根据权利要求1或2所述的保健食品，其特征在于：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、食用色素、稳定剂、包埋物、包衣预混剂一种或几种组合。
6.根据权利要求1或2所述的保健食品，其特征在于：所述的保健食品被制备成口服制剂。
7.根据权利要求6所述的保健食品，其特征在于：所述的口服制剂包括普通片剂、咀嚼片剂、软胶囊剂、硬胶囊剂、粉剂及颗粒剂。
8.权利要求1-7任一项所述的保健食品在制备对中老年人骨骼健康有辅助保护作用的保健食品中的用途。
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| 2型糖尿病人群中血清维生素D水平对同型半胱氨酸的影响;刘丛等;《河北医学》;20150630;第23卷(第6期);第901-905页 * |
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