CN107136514B - 一种由维生素d、k和维生素b12组成的营养素组合物 - Google Patents
一种由维生素d、k和维生素b12组成的营养素组合物 Download PDFInfo
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- CN107136514B CN107136514B CN201710368709.0A CN201710368709A CN107136514B CN 107136514 B CN107136514 B CN 107136514B CN 201710368709 A CN201710368709 A CN 201710368709A CN 107136514 B CN107136514 B CN 107136514B
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Abstract
本发明提供了一种营养素组合物，该组合物由维生素D2～100μg、维生素B120.2～200μg、维生素K 20ug～100mg及适量可以接受的辅料组成。本发明公开了一种对抑郁症或有抑郁倾向人群、焦虑及失眠人群及轻度老年痴呆或记忆力减退人群实施精准营养补充、保健或辅助治疗作用的营养素组合物。
Description
技术领域
本发明涉及一种营养素组合物，更准确地说，本发明涉及一种对维生素D、K及 B12营养素缺乏人群实施精准营养补充的营养素组合物，该组合物适于制成营养补充剂或保健食品。
背景技术
根据世界卫生组织报告，目前抑郁症是全球第四大疾病负担，也是导致患者功能残疾的主要原因之一，大约有1/7的人会在人生的某个阶段遭受抑郁症困扰。预计到 2020年，抑郁症将成为仅次于心血管病的第二大疾病。在中国，抑郁症的发病率约为6％，目前已确诊的抑郁症患者为3000万人左右。调查显示，这3000万抑郁症患者只有不到10％得到专业的救助和治疗，同时，还有相当多的患者根本没有意识到自己患有抑郁症，更没有进行过诊治。
焦虑症也称为焦虑性神经官能症，是精神疾病中比较常见的一员。不良的心理暗示、环境因素的影响或者遗传因素等都是导致人们患有焦虑症的原因。研究人员发现，与焦虑相关缺乏睡眠的问题，可长达6个月。过度的焦虑会增加癌症发生率：致癌的因素十分复杂，而精神因素在癌症的发生和发展上起着重要作用。现代医学发现，癌症好发于一些受到挫折后，长期处于焦虑、精神压抑、沮丧、苦闷、恐惧、悲哀等情绪紧张的人。精神心理因素并不能直接致癌，但过度的焦虑会增加轻生概率：美国一项研究表明：紧张水平高的男性，有大约25％患上了心脏病。而且轻生概率比正常人高23％。对于女性而言，高焦虑的女性的轻生概率比正常人高了23％。
老年痴呆症，又称阿尔茨海默病。调查数据显示，目前我国55岁以上人群患病率接近4.2％，65岁以上为7.2％，80岁以上患病比例高达20％-40％，中国老年痴呆症患者占世界同类人群的三分之一。越来越庞大的老年痴呆症患者群体成为公共卫生的一大难点。
发明内容
本发明的目的在于提供一种对维生素D、K及B12缺乏的人群实施精准营养补充的营养素组合物；特别是针对营养素缺乏的抑郁症或有抑郁倾向人群、焦虑及失眠人群及轻度老年痴呆或记忆力减退人群实施精准营养补充、保健或辅助治疗。
为了实现上述目的，本发明采用以下技术方案：
一种对维生素D、K及B12缺乏的人群实施精准营养补充的营养素组合物，由维生素D、维生素B12、维生素K和可以接受的辅料组成：其中维生素D含量为 2～100μg，优选2～15μg；所述维生素B12含量为0.5～200μg，优选0.5～10μg；所述维生素K含量为20～100mg，优选20～100μg。
本发明所述的营养素组合物，其特征在于：所述的维生素D主要是指维生素D2、D3，以及其他各组来源的各种维生素D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。
本发明所述的维生素K包括植物来源的K1、微生物来源的K2，以及人工合成的K3和K4，优选植物来源的K1和微生物来源的K2。
本发明所述的营养素组合物可制成普通片剂、咀嚼片剂、软胶囊剂、硬胶囊剂、粉剂及颗粒剂等口服剂型。
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、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(vitamin D)为固醇类衍生物，具有抗佝偻病、营养神经肌肉、造血及免疫等组织器官的作用。维生素D均为不同的维生素D原经紫外照射后的衍生物。植物不含维生素D，但维生素D原在动、植物体内都存在。维生素D是一种脂溶性维生素，有五种化合物，对健康关系较密切的是维生素D2(麦角钙化醇)和维生素D3(胆钙化醇)。维生素D可以帮助机体吸收钙质，其同样对于骨骼和肌肉的健康也至关重要，正常情况下皮肤暴露于太阳光后会产生维生素；人们通过食物比如牛奶等获得的维生素量非常少。据估计，世界范围内超过10亿人都因晒太阳不够而出现维生素D缺失的情况。
维生素B12是深红色晶体，熔点高(320℃时不熔)，无嗅无味。维生素B12溶于水，不溶于氯仿和乙醚，在pH4.5～5.0的弱酸条件下最稳定，在强酸(pH<2)或碱性溶液中则分解，遇热可有一定程度的破坏，但快速高温消毒损失较小。遇强光或紫外线易被破坏。维生素B12以辅酶的形式参与各种代谢过程，促进甲基的形成和转移，参与某些化合物的异构化作用、维持SH基的还原状态，促进DNA和蛋白质的合成，促进细胞的成熟，维持神经组织的正常功能，临床上可以用于治疗恶性贫血、肝脏疾病、神经炎、神经痛等。
维生素B12是人体必需的唯一含有金属离子的水溶性维生素，维生素B12缺乏时，主要影响造血系统和神经系统。通过对其生理功能的研究可知，维生素B12是一种人体重要的营养素，参与体内多种代谢，还可有效预防恶性贫血、老年痴呆、抑郁症等疾病，对保持人类身体健康起着重要作用。人类自身不能合成维生素B12，故需从膳食中获得。维生素B12缺乏是一全球性的营养素缺乏病，其发病率远比估计的高。近年来研究发现人群维生素B12的缺乏率为3～29％，但是摄入过量也会产生不良影响。国外研究还发现维生素B12可以延缓智力退化，同龄老年人中，血液中维生素B12高的人群认知能力远远高于体内维生素B12缺乏的人群。
维生素K又叫凝血维生素，天然的维生素K已经发现有两种，一种是脂溶性维生素，它是由绿色植物里提取出的维生素K1及由微生物中提取的维生素K2。另一种是水溶性维生素，为人工合成，即维生素K3和维生素K4。其中，随食物进入人体的维生素K1或K2其侧链可在体内分离，转成MK-4，它被认为具有不同于维生素K依赖性蛋白质的γ羧化作用，因而MK-4也被称为活性维生素K。近年国内外研究发现, 维生素K参与体内氧化还原过程，具有类激素样作用和镇静、镇痛作用,且基于脑重 MK-4浓度特别高这一发现，认为维生素K有一定的抗抑郁抗焦虑作用。
本发明所述的营养素组合物根据目标人群营养素缺乏特点，筛选功能协同的维生素进行科学组方，实施精准营养补充，作用效果显著强于组成成分的单独或联用的作用效果。。通过补充维生素D、维生素B12和维生素K有助于维持神经组织的正常功能，有效预防抑郁症焦虑症及老年痴呆疾病的发生，与现有产品相比，是一种效果更佳、更精准的维生素营养补充剂。
下面结合实施例对本发明的实施方式作进一步描述，以下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.复合维生素组合物普通片剂的制备
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D加入粘合剂中搅拌均匀，备用。另取维生素B12、维生素K、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。
为了证明本发明保健品的抗抑郁功效，我们设计了以下实验：
实验一：悬尾实验
实验方法：将18～22g雄性昆明小鼠随机分为7组，分别为空白对照组、阳性对照丙咪嗪组、复合维生素D+B12+K低剂量组、中剂量组、高剂量组、维生素B12+K 组、维生素K组，每组12只，分笼饲养，自由饮水饮食。按照表1剂量分别给药，每日1次，持续14d后进行悬尾实验：首先，使用实验台，用螺丝钳将金属制的固定棒固定在与地面平行的高度为35cm的地方。接着，用纸做隔板，使小鼠相互看不到对方倒吊的状态，用固定在固定棒上的用来悬挂小鼠尾巴的夹子将小鼠的尾巴固定，使其垂吊6分钟。用秒表测定在这6分钟里被视为不动时间(秒)的时间，即小鼠保持悬吊状态的静止时间，求出平均值。
表1悬尾实验各组组别及给药剂量
实验结果：测定结果用各组上述不动时间的平均值±标准误差来表示。组间的显著性差异采用单因素方差分析法，以5％为显著性水平进行检定。如表2实验结果所示，与空白对照组相比，维生素D+B12+K组动物不动时间平均值明显下降，且高、中剂量组下降程度更为明显，与维生素D+B12组及单用维生素D组相比，差异具有显著性。维生素D+B12+K组与阳性对照丙咪嗪组不动时间相近，而丙咪嗪是效果显著的抗抑郁药物，这表明本发明组合物对慢性应激所导致的抑郁状态有减轻及改善效果，且三种维生素组合应用效果更好。
表2悬尾实验各组不动时间测量结果
与空白组比较，#P<0.05，##P<0.01；三联组与二联组比较，*P<0.05，；与维生素K组比较，△P<0.05，△△P<0.01
实验二：强迫游泳实验
强迫游泳实验是抑郁症的动物模型实验中被经常使用的一种试验。在该试验中，强制使小鼠等动物在不可能逃避的空间中游泳，再使其处于不动状态。即，开始时为从该环境中逃脱而拼命游泳的小鼠，因无法出逃的压力而陷入无助感，逐渐进入不动状态。有报告指出，多数的抗抑郁药物可缩短因强迫游泳引起的不动状态的时间。
实验方法：将18～22g雄性昆明小鼠随机分为5组，分别为空白对照组、舍曲林组、复合维生素D+B12+K组、维生素B12+K组、维生素K组，每组12只，分笼饲养，自由饮水饮食。按照表3剂量分别给药，每日1次，并每天按照以下方法施加强迫游泳应激：向5L的聚乙烯烧杯(内径：27cm，高度：27cm)中注入18cm高(水的总量：4L)的水(24～26℃)，让小鼠在其中每天游泳1次，每次6分钟，连续进行14天。然后，在试验开始的第1天、试验开始的第7天，用秒表测定在上述6 分钟的强制游泳时间中剩下的4分钟里被视为不动时间的时间。应予说明，小鼠在水面漂浮并静止的状态判断为不动时间。然后，求出各不动时间的平均值，计算出将试验开始的第1天的不动时间的平均值作为100时的相对值(％)。
表3强迫游泳实验各组组别及给药剂量
| 组别 | 剂量(mg/kg) | 动物只数 |
| 空白对照组 | -- | 12 |
| 维生素D+B<sub>12</sub>+K组 | 15+10+100 | 12 |
| 维生素B<sub>12</sub>+K组 | 10+100 | 12 |
| 维生素K组 | 100 | 12 |
| 舍曲林组 | 5 | 12 |
实验结果：测定结果用各组上述不动时间的平均值±标准误差来表示，以5％为显著性水平进行检定。如表4实验结果所示，与空白对照组相比，各组动物相对不动时间在第7天平均值明显下降。维生素D+B12+K组不动时间少于维生素B12+K组，亦少于维生素K组，与舍曲林组不动时间相近，表明维生素D+B12+K对慢性应激所导致的抑郁状态有显著的减轻及改善效果。
表4强迫游泳实验各组不动时间(％)测定结果
与空白组比较，#P<0.05，##P<0.01；
实施例2.复合维生素组合物普通片剂的制备
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D加入粘合剂中搅拌均匀，备用。另取维生素B12、维生素K、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。
本发明组合物急性毒性试验：昆明小鼠40只，雌雄各半，体重18～22g，按性别和体重随机分为两组，空白对照组和维生素组合物组，每组20只，实施例2组合物粉碎，0.5％CMCNa混悬液，按最大体积灌胃给予小鼠5g/kg，空白对照组给予相应体积溶媒，均为一次灌胃给予，然后连续观察14天，所有动物给药后其外观、行为活动、精神状态、食欲、大小便、皮毛、肤色及呼吸等均未见明显毒性反应，观察结束后处死解剖动物，病理切片后观察心、肝、脾、肺、肾、胰腺、卵巢、睾丸、小肠等组织，亦未见明显异常。
实施例3.复合维生素组合物软胶囊的制备
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D、维生素B12、维生素K加入大豆油中制成混悬液，备用。另取明胶、纯化水、焦糖色、二氧化钛、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4.复合维生素组合物软胶囊的制备
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D、维生素B12、维生素K加入大豆油中制成混悬液，备用。另取明胶、纯化水、焦糖色、二氧化钛、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.复合维生素组合物软胶囊的制备
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D、维生素B12、维生素K加入大豆油中制成混悬液，备用。另取明胶、纯化水、焦糖色、二氧化钛、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.复合维生素组合物咀嚼片的制备
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D加入粘合剂中搅拌均匀，备用。另取维生素B12、维生素K与微晶纤维素混合、过筛，再加入甜菊苷、草莓香精、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有增强学习记忆能力的功效，我们设计了水迷宫实验，即乙醇干扰学习记忆能力的实验，通过对水迷宫训练的小鼠，给乙醇后学习记忆能力水平的观察来考察本发明保健品的功效作用。
实验方法：小鼠70只，随机分5组：模型组、阳性对照组(吡拉西坦)、复合维生素D+B12+K低剂量组、中剂量组、高剂量组，每组14只，分笼饲养，自由饮水饮食。按照表4剂量分别给药(模型组灌胃相应溶媒)，连续给药11d，在第7-10d期间每日于给药后1h进行迷宫训练，连续训练4d，剔除走出迷宫时间偏差较大的动物，在第11d训练前，模型组灌服体积分数为50％的乙醇5ml/kg后灌服相应溶媒，阳性对照组灌服50％乙醇5ml/kg后立即灌服吡拉西坦，其他组分别于灌服50％乙醇 5ml/kg后立即灌服相应药物，于给药后1h进行测试。
表4水迷宫实验各组组别及给药剂量
实验结果：如表5实验结果所示，各给药组给予乙醇前水迷宫的反应时间接近。给予乙醇后，模型组反应时间明显延长，显示小鼠已出现学习记忆功能缺失；各给药组的反应时间均小于模型组，与模型组相比，维生素D+B12+K组动物走出迷宫时间平均值明显下降，且高、中剂量组下降程度更为明显，有一定量效关系，阳性对照组动物走出迷宫的时间也明显下降。实验表明本发明组合物对乙醇诱导的小鼠学习记忆再现缺失有明显的保护作用。
表5走出水迷宫所需时间(秒)测量结果
与模型组比较，#P<0.05，##P<0.01
实施例7.复合维生素组合物颗粒剂的制备
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D加入粘合剂中搅拌均匀，备用。另取维生素B12、维生素K与蔗糖混合、过筛，再加入苹果粉、菠萝香精、淀粉、低取代羟丙纤维素混合，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8.复合维生素组合物粉剂的制备
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：复合维生素组合物硬胶囊剂制备
配方：
制备方法：将维生素B12与20％微晶纤维素混合，过筛，再加入维生素K、维生素D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，再加入蔗糖、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药物组合物的硬胶囊剂。
Claims (7)
1.一种用于抑郁症或有抑郁倾向人群、焦虑及失眠人群及轻度老年痴呆或记忆力减退人群的营养素组合物，由2 ~ 100 μg维生素D、0.5~ 200 μg维生素B12、20~100 μg维生素K及可以接受的辅料组成。
2.根据权利要求1所述的营养素组合物，其特征在于：所述维生素D含量为2 ~ 15 μg；所述维生素B12含量为0.5 ~10 μg。
3.根据权利要求1或2所述的营养素组合物，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或2所述的营养素组合物，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。
5.根据权利要求1或2所述的营养素组合物，其特征在于：所述的维生素K选自植物来源的K1、微生物来源的K2和人工合成的K3和K4。
6.根据权利要求1或2任一项所述的营养素组合物，其特征在于：所述的营养素组合物可制成普通片剂、咀嚼片剂、软胶囊剂、硬胶囊剂、粉剂及颗粒剂。
7.权利要求1~6任一项所述的营养素组合物在制备用于抑郁症或有抑郁倾向人群、焦虑及失眠人群及轻度老年痴呆或记忆力减退人群的制品中的用途。
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