CN106858608B - 一种有益于抑郁症患者健康的营养组合物 - Google Patents
一种有益于抑郁症患者健康的营养组合物 Download PDFInfo
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- CN106858608B CN106858608B CN201710079471.XA CN201710079471A CN106858608B CN 106858608 B CN106858608 B CN 106858608B CN 201710079471 A CN201710079471 A CN 201710079471A CN 106858608 B CN106858608 B CN 106858608B
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Abstract
本发明提供了一种营养补充剂、保健食品或药物组合物，公开了一种对抑郁症或有抑郁倾向人群实施精准营养补充、保健或辅助治疗作用的营养组合物，该组合物由叶酸100μg～2mg、维生素B12 0.5～200μg、维生素K 20μg～100mg及适量食品或药品可接受辅料组成。
Description
技术领域
本发明涉及一种营养补充剂、保健食品或者药物组合物，更准确地说，本发明涉及一种对抑郁症和抑郁倾向患者精准营养补充及镇静作用的营养补充剂、保健食品或药物组合物。
背景技术
现代社会工作、生活压力越来越大，很多时候人们都处于焦躁、抑郁的边缘，严重时出现抑郁症、焦虑神经症、躁狂症、精神分裂症等精神疾病。抑郁症是以行为上出现异常表现、心境低落为主要症状的一种精神情志障碍性疾病，抑郁症会对人的消化、免疫及神经系统等技能产生影响甚至造成损伤，而且该疾病具有高发病率、难治愈和高复发率等特点。它严重困扰着人们正常工作、学习和生活，重症病人的高自杀率倾向还直接影响社会安定。
血浆同型半胱氨酸(Homocysteine，Hcy)升高可能是神经精神紊乱的危险因素。高Hcy与抑郁症相关，机制可能涉及:1)抑郁患者体内可能存在由Hcy到甲硫氨酸的甲基化过程障碍,甲硫氨酸是S-腺苷蛋氨酸(SAM)的前体,而后者是脑中包括单胺递质在内的许多神经递质和蛋白质的甲基供体。2)高Hcy导致钠-钾ATP酶抑制，该酶在脑细胞膜含量较高,是维持神经元兴奋性离子成分的关键酶,一旦活性受抑则兴奋性谷氨酸释放，可导致神经元死亡。3)Hcy及其代谢产物可作为离子通道和代谢型谷氨酸受体激动剂而产生神经毒性作用。
从我们多年积累的研究看，叶酸是对抗Hcy升高的最有效手段。此外，叶酸及维生素B12参与单胺类递质合成所必需的碳代谢过程,抑郁症患者常见血清叶酸和维生素B12浓度低下，叶酸缺乏患者对抗抑郁剂的效果不如叶酸正常患者，维生素B12水平亦与抑郁症预后显著相关。维生素K还能调节神经系统功能，有镇静、镇痛作用。目前市场上多种维生素产品众多，但尚无针对抑郁症或抑郁倾向人群的维生素补充产品，本发明基于精准营养，将解决这一问题。
发明内容
本发明的目的在于提供一种对抑郁症或有抑郁倾向的患者具有营养保护和镇静作用的营养补充剂、保健食品或药物组合物。
为了实现上述目的，本发明采用以下技术方案：
一种对抑郁症或抑郁倾向人群具有营养保护和镇静作用的营养补充剂、保健食品或药物组合物，由以下成分组成：
(1)叶酸；
(2)维生素B12；
(3)维生素K；
(4)辅料。
在上述营养补充剂、保健食品或药物组合物中，叶酸含量为100μg～2mg，维生素B12含量为0.5～200μg。维生素K含量为20μg～100mg；
优选地，本发明所述的营养补充剂、保健食品或药物组合物，叶酸含量为400～1600μg，维生素B12含量为5～50μg，维生素K含量为60μg～10mg。
更加优选地，本发明所述的营养补充剂，叶酸含量为400～500μg，维生素B12含量为5～20μg，维生素K含量为80～200μg。
更加优选地，本发明所述的药物组合物，叶酸含量为400～1600μg，维生素B12含量为10～200μg，维生素K含量为100μg～50mg。
本发明中，所述的叶酸包括叶酸、5-甲基四氢叶酸(钙)、甲酰四氢叶酸、亚叶酸、左亚叶酸钙等，即包括人工合成及植物提取物来源的各种叶酸形式，优选叶酸和5-甲基四氢叶酸(钙)。
本发明中，所述的B12包括钴胺素和氰钴胺素。
本发明中，所述的叶酸维生素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。
本发明中，所述的抑郁症或有抑郁倾向的应用包括抑郁症、焦虑症、精神分裂症、神经症、癫痫症、躁狂症、妄想症、恐怖性焦虑障碍等。
本发明中，所述的营养补充剂、保健食品或药物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，所述的辅料选自食品或药品可接受的填充剂、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。
其中，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、麦芽糊精等的一种或几种。
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、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、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。
本发明所述的营养补充剂、保健食品或药物组合物，针对抑郁症患者主要缺乏叶酸和维生素B12，以及具有镇静作用的维生素K进行科学组方，从而确保产品的功效，通过补充最佳剂量叶酸、维生素B12和维生素K，提高抑郁症或有抑郁倾向人群血清叶酸和B12水平，降低Hcy，兼可以镇静，改善神经系统功能，协同预防抑郁症的复发，改善或辅助治疗抑郁症状。
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及核酸合成等。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，进而影响一碳单位传递。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。加之国人高温烹调蔬菜的习惯，叶酸缺乏率(65％)明显高于欧美国家。
抑郁症患者MTHFR C677T等位基因T过度表达,频率为57.4％,患者MTHFR677TT突变频率明显高于对照组,而C/C基因型的频率显著低于对照组,提示等位基因T可能与抑郁症发病有关,该等位基因的存在使抑郁症的易患性增加。鉴于MTHFR 677TT突变型与重性抑郁症的发病有明确相关性，此类病人应采用5-甲基四氢叶酸才有更好的补充叶酸效果。
维生素B12以辅酶的形式存在，可以增强叶酸的利用率，两者组合对维持中枢神经系统功能正常也有重要作用：正常的甲基化反应是神经系统功能发挥的物质基础，S-腺苷蛋氨酸是大脑内甲基(-CH3)的重要供体，如上述，这些甲基和其它一碳单位都是由叶酸传递(需要维生素B12辅助)而来，它们是神经递质合成的重要原料。研究发现，叶酸或维生素B12缺乏导致高Hcy血症。维生素B12还对神经系统还有营养作用，参与神经组织中一种脂蛋白的合成，有消除烦躁不安、集中注意力、增强记忆和平衡感的功能。总之，维生素B12和叶酸可协同促进抑郁病人神经系统功能改善。
维生素K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。
本发明所述的营养补充剂、保健食品或药物组合物，提供了一种针对抑郁症或有抑郁倾向人群营养缺乏情况，实施精准营养补充、保健或药物治疗作用的产品，添补了现有市场的空白。下面结合实施例对本发明的实施方式作进一步描述。
具体实施方式
实施例1：本发明所述营养补充剂的片剂制备(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K加入粘合剂中搅拌均匀，备用。另取维生素B12、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K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，即制得本发明所述营养补充剂的片剂。
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K、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，即制得本发明所述保健食品的软胶囊剂。
实施例3：本发明所述药物组合物硬胶囊剂制备(1000粒量)
配方：
制备方法：将叶酸与20％微晶纤维素混合，过筛，再加入维生素K、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药物组合物的硬胶囊剂。
取本实施例3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3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。
本药物组合物升高叶酸、降低Hcy的药效学研究：
实验动物：雄性SD大鼠，SPF级，6周龄，体重在150g～200g,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：30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两组，一组继续叶酸和B12缺乏饲料喂养作为模型组，另一组也继续喂饲叶酸和B12缺乏饲料，但同时以100mg/kg剂量(以胶囊内容物质量计)灌胃给药，连续给药4周，眼眶采血，检测大鼠血清叶酸、B12及Hcy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。
动物实验结果(表1)表明：本药物组合物具有显著提高大鼠血清中B12及叶酸水平、降低血清Hcy水平的作用。
表1 本发明药物组合物对大鼠血清B12、叶酸、Hcy水平的影响
注：模型组与对照组比较，*P<0.05,**P<0.01；给药组与模型组比较，△P<0.05，△△P<0.01。
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K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K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：本发明所述营养补充剂的咀嚼片制备(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K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K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营养补充剂的咀嚼片。
Claims (7)
1.一种降低血清Hcy水平的营养补充剂，由100 μg ~2 mg叶酸、0.5~200 μg维生素B12、20 μg ~100 mg维生素K及食品或药品可接受的辅料组成。
2.根据权利要求1所述的营养补充剂，其特征在于：所述叶酸含量为 400~1600 μg；维生素B12含量为 5~50 μg；维生素K含量为 60 μg ~10 mg。
3.根据权利要求1~2任一项所述的营养补充剂，其特征在于：所述的叶酸包括合成叶酸、5-甲基四氢叶酸钙、甲酰四氢叶酸、左亚叶酸钙。
4.根据权利要求1~2任一项所述的营养补充剂，其特征在于：所述的维生素B12包括氰钴胺素。
5.根据权利要求1~2任一项所述的营养补充剂，其特征在于：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。
6.根据权利要求1所述的营养补充剂，其特征在于：所述的营养补充剂可制成普通片剂、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任一项所述的营养补充剂在制备可用于辅助治疗抑郁症或抑郁倾向患者的营养补充剂中的用途。
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