CN111939154A - 抗衰老组合物及其用途和含有它的保健食品与药品 - Google Patents
抗衰老组合物及其用途和含有它的保健食品与药品 Download PDFInfo
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- CN111939154A CN111939154A CN202010860136.5A CN202010860136A CN111939154A CN 111939154 A CN111939154 A CN 111939154A CN 202010860136 A CN202010860136 A CN 202010860136A CN 111939154 A CN111939154 A CN 111939154A
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- aging
- vitamin
- nicotinamide mononucleotide
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- A—HUMAN NECESSITIES
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Abstract
本发明提供了一种抗衰老组合物，其包含如下组分的复合物：安全有效剂量的烟酰胺单核苷酸、其药学上可接受的盐或它们的混合物；药学上可接受的复合维生素B；及硫辛酸、其药学上可接受的盐或它们的混合物。本发明还提供了包含该抗衰老组合物的药物，以及该抗衰老组合物在制备用于抗衰老的保健品和药品中的用途。
Description
技术领域
本发明涉及复方抗衰老组合物及其用途和含有它的保健食品与药品。具体而言，本发明涉及使用含烟酰胺单核苷酸的复方组合物来延缓机体衰老速度且消除由单一配方使用时所出现的副作用。
背景技术
在数千年历史进程中，健康、长寿一直都是人类所追求的。随着科学技术的发展，人类平均寿命在不断的提高。但是，很多时候，仅仅长寿不能完全满足人们对美好生活的需求。在长寿的基础上，减缓衰老以维持高质量生活吸引了更多人的关注。
烟酰胺单核苷酸别称β-烟酰胺单核苷酸，英文β-Nicotinamide Mononucleotide(简称NMN，本文中采用该简称)，化学分子式C11H15N2O8P，分子量334.22。它在多种动物与人体研究中展现出了具有抗衰老的潜力；但同时，其副作用也在人体试验中显现出来，如疲乏，消化不良与腹泻等症。由于此类副作用给服用者带来困扰，甚至有可能因为副作用而加速这部分服用者衰老。故而单一使用烟酰胺单核苷酸作为药品或特殊用途食品一直备受争议。
因此如何保持烟酰胺单核苷酸的预防或治疗衰老作用的同时有效降低或消除其副作用是亟待解决的问题。
发明内容
发明人惊奇地发现，使用含有硫辛酸，复合维生素B和烟酰胺单核苷酸的组合物，不但具有抗衰老的功效，且消除了单一使用烟酰胺单核苷酸时所造成的副作用。
由此，本发明提供了一种用于抗衰老的组合物，该组合物包含如下组分的复合物：
(a)安全有效量的烟酰胺单核苷酸，其药学上可接受的盐或其混合物；
(b)安全有效量的硫辛酸，其药学上可接受的盐或其混合物；和
(c)安全有效量的复合维生素B，其药学上可接受的盐或其混合物。
其中所述的烟酰胺单核苷酸在所述抗衰老药物或保健品组合物中主要起抗衰老作用，优选地，所述烟酰胺单核苷酸的单剂量为l-20mg/公斤体重/天。
其中所述的硫辛酸在所述抗衰老药物或保健品组合物中主要起抗氧化作用，优选地，所述硫辛酸的单剂量为l-20mg/公斤体重/天。
其中所述的复合维生素B在所述抗衰老药物或保健品组合物中主要起辅助吸收作用。优选地，所述复合维生素B的单剂量为l-20mg/公斤体重/天。
在另一方面，本发明提供了一种用于抗衰老的保健食品，其包含前述的抗衰老组合物。
在另一方面，本发明提供了前述的抗衰老组合物在制备用于抗衰老的保健食品中的用途。
在另一方面，本发明提供了一种用于抗衰老的药物，其包含前述的抗衰老组合物。
在另一方面，本发明提供了前述的抗衰老组合物在制备用于抗衰老的药物中的用途。
目前有大量的实验显示NMN具备抗衰老功效，但是根据Dellinger等的实验表明，单一使用NMN会造成头晕、头痛、腹泻、乏力等副作用。本发明根据这些副作用在配方上进行了改进从而消除了这些副作用。本发明复合配方可以提供比任何单一配方更全面、更完善、更均衡的功效，服用更加方便。
具体实施方式
除非特别指出，本文的所有百分数和比率是以重量为基。另外，除非特别指出，所有的测量都在25℃下做出。
在本发明中，“抗衰老”具有更广泛的含义，包括例如衰老现象的改善、衰老的延迟和回复青春，除了在狭义上的抗衰老之外，还包括诸如使伴随年龄增长的身体功能、生理功能、心理功能的衰退得到抑制、改善、延迟、恢复青春活力、机体机能正常化等的一切。具体地，“抗衰老”是指针对下述问题的抑制、改善和延迟等的效果，例如皮肤的衰老症状(皱纹、松垂的发生、皮肤张力减退或丧失等)、因衰老导致的干皮(皮肤的保湿性降低)、皮肤瑕疵、色斑、皮肤粗糙、激素(生长激素、甲状腺激素、肾上腺皮质激素、性激素、催乳激素、抗利尿激素、甲状旁腺激素、褪黑激素等)的分泌的减少和增加、由活性氧导致的细胞(脑细胞、心肌细胞等)的损害、头发和牙齿的脱落、视力和听力的下降、运动功能的下降、骨密度的降低、体能的降低、记忆力的下降、学习能力的下降、免疫功能的下降和神经退行性疾病的发生等。抗衰老的效果可以表现在诸多方面，例如睡眠质量改善、记忆力改善、免疫力提高、脸部气色改善、皮肤紧致、脱发减少、食欲提高和血糖血压血脂趋于正常等。
如本文所用，术语“药学上可接受的”是指在合理的医学判断范围内、适合用于与人类和动物的组织接触而没有过度的毒性、刺激性、变态反应或其它问题或并发症、与合理的利益/风险比相称的那些化合物、材料、组合物和/或剂型。本发明中提及的活性成分或组分可以形成稳定的药学上可接受的酸或碱盐，并且在这样的情况下，施用作为盐的化合物可能是恰当的。酸加成盐的示例包括乙酸盐，己二酸盐，抗坏血酸盐，苯甲酸盐，苯磺酸盐，碳酸氢盐，硫酸氢盐，丁酸盐，樟脑酸盐，樟脑磺酸盐，胆碱，柠檬酸盐，环己基氨基磺酸盐，二亚乙基二胺，乙磺酸盐，富马酸盐，谷氨酸盐，乙醇酸盐，半硫酸盐，2-羟乙基磺酸盐，庚酸盐，己酸盐，盐酸盐，氢溴酸盐，氢碘酸盐，羟基马来酸盐，乳酸盐，苹果酸盐，马来酸盐，甲磺酸盐，葡甲胺，2-萘磺酸盐，硝酸盐，草酸盐，双羟萘酸盐，过硫酸盐，苯基乙酸酯，磷酸盐，二磷酸盐，苦味酸盐，新戊酸盐，丙酸盐，奎尼酸盐，水杨酸盐，硬脂酸盐，琥珀酸盐，氨基磺酸盐，磺胺酸盐，硫酸盐，酒石酸盐，甲苯磺酸盐(对甲苯磺酸盐)，三氟乙酸盐和十一酸酯。碱盐的示例包括铵盐；碱金属盐例如钠、锂和钾盐；碱土金属盐例如铝、钙和镁盐；与有机碱的盐例如二环己基胺盐和N-甲基-D-葡糖胺；以及与氨基酸例如精氨酸、赖氨酸、鸟氨酸等的盐。
在一个实施方式中，所述组合物中的各有效成分可以以治疗安全有效量存在。如本文所用，术语“安全有效量”是指化合物或组合物的量足以显著且正性地改变待治疗的症状和/或病情(例如提供正性临床反应)并且安全。用于组合物中的活性成分的安全有效量将随所治疗的特定病情、病情的严重程度、治疗的持续时间、同时疗法的性质、所采用的特定活性成分、所利用的特定添加剂、以及主治医师的知识和专业知识内的类似因素而变化。
如本文所用，术语“预防”是指防止疾病、障碍或病症在可能有疾病风险但尚未被诊断为患有该疾病的受试者中发生。在人口研究中可以证明预防(以及有效预防的剂量)。例如，相对于未治疗的对照人口，预防给定疾病或医学病症的有效量是减少治疗人口中发生率的有效量。
如本文所用，术语“治疗”是指用于获得有益或期望的临床结果的方法。此外，本文提及“治疗”包括提及治愈性治疗、姑息性治疗和预防性治疗。术语“治疗”是指抑制、预防或阻止病理(疾病、障碍或病症)的发展或进展和/或引起病理的减轻、缓解或消退。本领域技术人员将理解，可以使用各种方法和测定来评估病理学的发展，并且类似地，可以使用各种方法和测定来评估病理学的减轻、缓解或消退。
如本文所用，术语“受试者”可以包括哺乳动物，优选患有病理特征的任何年龄的人。优选地，该术语还可以包括有发展病理特征风险的个体。
本发明的抗衰老剂含有烟酰胺单核苷酸作为活性成分，提供抗衰老效果。烟酰胺单核苷酸(化学式：C11H15N2O8P)是在包括人在内的许多生物的体内产生的化合物，用以下的式(1)表示。烟酰胺单核苷酸通常被称为NMN，并且作为辅酶NAD+的生物合成中涉及的中间代谢物而被人们知晓。
作为抗衰老剂的活性成分的烟酰胺单核苷酸在生物体内，由肝脏组织在代谢途径，即在涉及经由犬尿氨酸途径由喹啉酸合成烟酰胺腺嘌呤二核苷酸(NAD)的途径中产生。通过膳食摄取的烟酸被肝脏吸收，转化为烟酰胺，烟酰胺通过血流被供给到全身。各细胞从血液中吸收烟酰胺，并将其转化为NAD和NADP而使用它们。烟酰胺也可由色氨酸生物合成。
烟酰胺单核苷酸包括两种类型即α-形和β-形作为光学异构体，并且在本发明中使用β-形。烟酰胺单核苷酸是通过例如从烟酰胺和核糖合成烟酰胺核苷(参见Bioorg.Med.Chem.Lett.,12,1135-1137(2002))，接着使核糖部分的5-羟基磷酸化(参见Chem.Comm.,1999,729-730)而获得的。具体地，例如，首先将烟酰胺和L-核糖四乙酸酯溶解在无水乙腈中，在氮气流中，加入过量的三甲基甲硅烷基三氟磺酸，然后在室温下搅拌，加入甲醇以停止反应，由此来制备反应溶液。将上述反应溶液倒入填充有活性炭的柱中，用蒸馏水清洗，然后用甲醇洗脱，收集其产物。接着，为了进行该产物的L-核糖部分的5-羟基的磷酸化反应，而将上述产物溶解在三甲氧基磷酸中、在冰浴条件下滴加磷酰氯，在氮气流下进行搅拌，加入氢氧化钠水溶液以中和，停止反应，由此制备反应溶液。将冷乙腈-醚溶液加入上述反应溶液中。然后，使下层(水相)通过阴离子交换树脂以收集反应物，并进一步用阳离子交换树脂进行纯化，由此可以收集到高纯度的烟酰胺单核苷酸。烟酰胺单核苷酸可购自Oriental Yeast Co.,ltd.和Bontac Bio-engineering(Shenzhen)Co.,Ltd，并且这些商业产品可被购买使用。
烟酰胺单核苷酸是含有少量杂质的纯化产物，尤其优选其纯度为90％以上，并且进一步优选其纯度为95％以上。当纯度为90％或更低时，可能产生不良气味，或者烟酰胺单核苷酸的效果可能被降低进而未能充分地提供本发明的效果。
如上所述，虽然烟酰胺单核苷酸的纯度优选为90％以上，但纯度(质量比)被定义为通过从无水项的100％中减去而获得的值。因此，烟酰胺单核苷酸的纯度可以用下式获得：烟酰胺单核苷酸纯度(％)＝100-烟酰胺单核苷酸以外的杂质(％)。这里，这些杂质包括在NAD代谢途径中涉及的烟酰胺单核苷酸以外的代谢物，特别是烟酰胺和烟酰胺腺嘌呤二核苷酸。当在本发明中使用的烟酰胺单核苷酸含有诸如在NAD代谢途径中涉及的上述代谢物的外来元素时，例如烟酰胺单核苷酸向生物体细胞的吸收可能降低，导致本发明的效果的降低。通过使用标准样品的绝对校准曲线方法进行NAD代谢途径中所涉及的上述杂质的定量测定，其中将干燥的烟酰胺单核苷酸粉末的测试溶液注入HPLC设备中，并且求出所获得的色谱的峰面积(纵轴：峰面积，横轴：浓度)。由于在微量物质的情况下峰高的使用确保了高精度的定量测定，因此可根据装置的特性适当地选择要使用的装置。基于保留时间识别分离的物质。
目前，烟酰胺单核苷酸(NMN)可通过酵母菌发酵、化学合成或体外酶催化制备。优选地，本发明使用的烟酰胺单核苷酸通过体外酶催化制备。通过该方法制备的烟酰胺单核苷酸不含有机溶剂残余，也不存在手性问题，产生和机体内同型的NMN，并且具有成本优势。
硫辛酸(alpha lipoic acid)是一种存在于线粒体的辅酶，类似维生素，能消除导致加速老化与致病的自由基。硫辛酸在体内经肠道吸收后进入细胞,兼具脂溶性与水溶性的特性。硫辛酸属于酵母及一些微生物的生长因素，在多酶系统中起辅酶作用，催化丙酮酸氧化脱羧成乙酸及α-酮戊二酸氧化脱羧成琥珀酸的反应中转酰基作用。
B族维生素是人体内糖类、脂肪、蛋白质等代谢时不可缺少的物质。B族维生素多数都溶于水，包括维生素B1(硫胺素)、维生素B2(核黄素)、维生素B3(烟酸)、维生素B4(磷酸氨基嘌呤)、维生素B5(泛酸、遍多酸)、维生素B6(吡哆素)、维生素B7(维生素H)、维生素B8(腺嘌呤核苷酸)、维生素B11(叶酸)、维生素B12(钴胺素)、维生素B13(乳清酸)、维生素B15(潘氨酸)、维生素B17(杏素)、维生素Bt(肉毒碱)、维生素Bx
(对氨基苯甲酸)、胆碱、肌醇(环己六醇)等。其中维生素B1、维生素B2、维生素B3、维生素B5、维生素B6、维生素B11、维生素B12等为人体常用，作为辅酶对人体内糖、脂肪和蛋白质的代谢起着至关重要的作用。本发明中，除非特别指明，术语“复合维生素B”是指B族维生素的复合物，尤其是市面上可以在药店普遍商购的那些。优选地，复合维生素B包含维生素B1(硫胺素)，维生素B2(核黄素)，维生素B3(烟酸)，维生素B5(泛酸、遍多酸)，维生素B6(吡哆素)，维生素11(叶酸)，维生素B12(钴胺素)，肌醇(环己六醇)，胆碱，和生物素。特别优选地，适用于本发明的典型复合维生素B包含如下组分：
维生素B1 25mg；
维生素B2 25mg；
维生素B6
维生素B12
胆碱110mg；
烟酸25mg；
叶酸400mcg；
生物素45mcg；
泛酸25mg；
肌醇5mg；
对胺基苯甲酸5mg。
烟酰胺单核苷酸、硫辛酸与复合维生素B目前都可以商购获得。
根据本发明，硫辛酸、烟酰胺单核苷酸和复合维生素B的配合比例不受限制，只要其能够在有效地发挥抗衰老功效同时降低烟酰胺单核苷酸的副作用即可。但是，从获取本发明的最大效果的角度出发，优选调节三者的配合比例，使得成人每天摄取量为，硫辛酸为l-20mg/公斤体重/天，烟酰胺单核苷酸为l-20mg/公斤体重/天，复合维生素B为l-20mg/公斤体重/天。在一个优选的实施方式中，基于100重量份的抗衰老组合物，所述烟酰胺单核苷酸的量可以为10-80重量份，优选为20-50重量份，更优选为30-50重量份。在一个优选的实施方式中，基于100重量份的抗衰老组合物，所述硫辛酸的量可以为10-80重量份，优选为20-50重量份，更优选为30-50重量份。在一个优选的实施方式中，基于100重量份的抗衰老组合物，所述复合维生素B的量可以为10-80重量份，优选为20-50重量份，更优选为30-50重量份。
本发明的抗衰老剂易于通过常规程序混合硫辛酸、烟酰胺单核苷酸、复合维生素B和其他辅助成分来制造。在提供本发明的效果的范围内，其它辅助成分没有特别限制。其它辅助成分的实例包括常用于食品和药品领域中的辅助成分，例如各种维生素、微量元素、柠檬酸、苹果酸、香料和无机盐等。根据本发明，在一个优选的实施方式中，所述组合物还可以包括医学上可接受的添加剂。在一个更优选的实施方式中，所述添加剂可以为稀释剂、崩解剂、防腐剂和抗氧化剂中的至少一种。例如，当制成胶囊剂时，用于胶囊剂制剂的合适的添加剂包括，例如惰性稀释剂，如乳糖、碳酸钠、磷酸钙或碳酸钙；造粒和崩解剂，如玉米淀粉或藻酸；防腐剂，如对羟基苯甲酸乙酯或丙酯；和抗氧化剂，如抗坏血酸。
本发明的抗衰老制剂主要通过口服，抑制衰老。在本发明中，如前所述，“抗衰老”除了在狭义上的抗衰老之外，还具有例如衰老现象的改善、衰老的延迟和恢复青春活力等更广泛的含义，因此包括诸如使伴随年龄增长的身体功能、生理功能、心理功能的衰退得到抑制、改善、延迟、恢复青春、机体机能正常化等的一切。具体地，“抗衰老”可包括针对下述问题的抑制、改善和延迟的效果，例如皮肤的衰老症状(皱纹、松垂的发生、皮肤张力的丧失或减退等)、因衰老导致的干皮(皮肤的保湿性降低)、皮肤瑕疵、色斑、粗糙皮肤、激素(生长激素、甲状腺激素、肾上腺皮质激素、性激素、催乳激素、抗利尿激素、甲状旁腺激素、褪黑激素等)的分泌的减少和增加、由活性氧导致的细胞(脑细胞、心肌细胞等)的损害、头发和牙齿的脱落、视力和听力的下降、运动功能的下降、骨量的降低、体力的降低、记忆力的下降、学习能力的下降、免疫功能的下降和老年病的发生等。
用于制造抗衰老制剂的方法没有特别限制，可以与其形态对应地适当选择用于制造抗衰老剂的一般制造方法。例如，当形态为粉末时，可通过均匀混合烟酰胺单核苷酸和根据需要而包含的其它成分来制造抗衰老制剂。作为活性成分的烟酰胺单核苷酸在市场上流通并且是可商购的。特别地，对于烟酰胺单核苷酸合成制作，最近国家食品药品管理局已经针对烟酰胺单核苷酸等特殊用途食品建立了质量管理体系和量产体系。
本发明的抗衰老制剂可用作食品和医疗产品。在用作食品的情况下，抗衰老剂在食品领域可以作为抗衰老特殊用途食品而提供。食品形态的日常摄取持续提供抗衰老效果，在抗衰老方面特别有效。作为本发明对象食品类型没有特别限制，除了一般食物产品之外，还可以包括功能性食品、特定保健用食品、膳食补充食品、食物添加剂、饲料、护理食品、饮食治疗食品、治疗饮食、减肥食品和类似食品。具体地，例如，甜食(口香糖、糖果、甜饼、橡皮糖、饼干、蛋糕、巧克力、日本糖果、果冻等)、面包、面条、大米/谷物加工食品(谷类等)、肉类加工食品、鱼和贝类加工食品、蔬菜加工食品、现成食品、发酵食品、调味品(酱，调料、番茄酱等)、香料、乳制品(酸奶、奶酪、牛奶等)、冰淇淋、冷冻食品、蒸煮袋食品、饮料(碳酸饮料、软饮料、乳类饮料、酒精饮料、运动饮料、果味饮料、茶、营养饮料、浓缩饮料等)、粉末状饮料(粉末汁，粉末汤等)。食品的形态不受限制，尤其是在功能性食品物、特定保健用食品等的情况下，食品可以加工成例如粉末、片剂、丸剂、颗粒、硬胶囊制剂、软胶囊制剂、果冻、液剂和膏剂等形态而提供。
食品的摄取根据食品的类型、摄取食品的对象的年龄、性别和体重、预期效果和症状等而不同。然而，包含在食品中的硫辛酸、烟酰胺单核苷酸和复合维生素B的每日摄取量通常分别为1mg-500mg，优选为5mg-300mg，更优选为50mg-300mg。食品中硫辛酸、烟酰胺单核苷酸和复合维生素B的配合比例可以相对于总食物重量在100％以下的范围内适当地设定。
同时，本发明的抗衰老剂在医药领域可以作为抗衰老用的药品(包括准药品)口服或非口服给药。所述药品的剂型没有特别限制，可包括，例如，粉末、水剂、肠溶制剂、溶胶制剂、舌下喷雾、片剂、持续性片剂、咀嚼片、泡腾片、含片、口含片、舌下片、胶囊剂、细颗粒剂、颗粒剂、丸剂、干糖浆、悬浮剂、糖浆等的口服给药的制剂，滴眼剂、洗眼液、眼药膏、注射剂、输液、外用制剂。在这些剂型中，考虑到服用方便、活性成分的稳定性等，优选如粉末、水剂、肠溶制剂、溶胶制剂、舌下喷雾、注射剂、片剂和胶囊剂等制剂。
考虑到物理化学性质、生物学性质等类似的性质，上述药品可适当地含有适合于其剂型的药理上允许的已知的制剂用添加剂。作为这种制剂用添加剂可列举为例如赋形剂(乳糖、淀粉、微晶纤维素、磷酸钠等)、溶剂(水、大豆油、盐水、注射用非水性溶剂等)、粘合剂(淀粉、明胶、阿拉伯树胶、海藻酸钠、羧甲基纤维素钠、甲基纤维素、乙基纤维素、羟丙基甲基纤维素、羟丙基纤维素、聚乙烯吡咯烷酮等)、崩解剂(淀粉、羧甲基纤维素钠等)、润滑剂(滑石、硬脂酸镁、硬脂酸钙、聚乙二醇、蔗糖脂肪酸酯等)、包衣剂(白糖、HPC、虫胶、明胶、甘油、羟丙基甲基纤维素，羟丙基甲基纤维素邻苯二甲酸酯、醋酸纤维素邻苯二甲酸酯等)、稳定剂(亚硫酸氢钠、硫代硫酸钠、乙二胺四乙酸钠、柠檬酸钠、抗坏血酸、二丁基羟基甲苯等)、防腐剂(对羟基苯甲酸甲酯、对羟基苯甲酸乙酯、对羟基苯甲酸丙酯、苄醇、苯酚、氯丁醇，苯扎氯铵、苄索氯铵、脱氢乙酸钠、硫柳汞等)、粘稠剂(甲基纤维素、羧甲基纤维素钠、硫酸软骨素、海藻酸钠等)、悬浮剂(各种非离子表面活性剂、甲基纤维素、羧甲基纤维素钠等)、乳化剂(阿拉伯树胶、胆固醇、脱水山梨醇倍半油酸酯，聚山梨酯80、月桂基硫酸钠等)、缓冲剂(柠檬酸、乙酸、磷酸钠和硼酸)、表面活性剂(氢化蓖麻油、聚山梨酯80等)、着色剂(水溶性食用色素、色淀色素等)、矫味剂(乳糖、白糖、葡萄糖、甘露醇等)、芳香剂(芳族精油)，增塑剂(邻苯二甲酸酯、植物油、聚乙二醇等)。
上述药品的剂量根据给药对象的年龄、体重、症状、给药次数等而不同，因此不能被同等地限定。但是，作为该药品的剂量，成人每天的给药量通常为1mg-500mg，优选为5mg-300mg，更优选为50mg-300mg。药品中硫辛酸、烟酰胺单核苷酸和复合维生素B的配合比例可以根据剂型、药品的剂量等进行适当设定。
上述药品的给药次数可以根据例如给药对象的年龄、体重、症状和每次给药的剂量适当地设定。每天给药的次数可以举例说明为1-3次。
在另一方面，本发明提供了一种用于抗衰老的保健食品，其包含前述的抗衰老组合物。
在另一方面，本发明提供了前述的抗衰老组合物在制备用于抗衰老的保健食品中的用途。
在另一方面，本发明提供了一种用于抗衰老的药物，其包含前述的抗衰老组合物。
在另一方面，本发明提供了前述的抗衰老组合物在制备用于抗衰老的药物中的用途。
本发明发明人惊奇地发现，同时在硫辛酸与复合维生素B的辅助下，NMN抗衰老作用有明显提高，同时明显减弱或消除了其单一制剂的副作用。发明人经研究后认为:硫辛酸作为抗氧化剂和作为丙酮酸脱氢酶(pyruvate dehydrogenase)和甘氨酸脱羧酶(glycinedecarboxylase)的辅酶，外源性硫辛酸被细胞内两种或多种酶还原而增进了细胞清除自由基的进程，增加谷胱甘肽(glutathione)合成,调控转录因子活性，降低了巨噬细胞髓磷脂的吞噬作用。NMN、硫辛酸与复合维生素B在体内代谢中与TPP(焦磷酸硫胺素)和NAD(烟酰胺腺嘌呤二核苷酸)等发生生化反应，在结构与功能上进行统一从而增强了临床药效，消除了副作用。
目前有大量的实验显示NMN具备抗衰老功效，但是根据Dellinger等的实验表明，单一使用NMN会造成头晕、头痛、腹泻、乏力等副作用。本发明根据这些副作用在配方上进行了改进从而不但消除了这些副作用，且在原有配方基础上提供了更全面、更完善的保健/治疗功效。申请人发现，本发明含烟酰胺单核苷酸，硫辛酸和复合维生素B的组合物不仅可以用于有效地减缓衰老，而且可减少烟酰胺单核苷酸的病理副作用，并由此扩大烟酰胺单核苷酸的适用人群，提高使用人群的舒适感和依从性。本发明组合物特别适合口服，给药时可以片剂、胶囊、粒剂、水剂、肠溶制剂或溶胶制剂使用。同时也可使用注射剂或舌下喷雾进行使用。
下面通过实施例对本发明作更具体的举例说明。
实施例
下列实施例进一步揭示和显示了本发明范围里的技术方案。给出的实施例仅供阐述，并非用来限制本发明，因为能作出许多改变但不背离本发明的精神和范围。
实施例中使用的主要原材料及其来源：
烟酰胺单核苷酸(nicotinamide mononucleotide)，购自Double WoodSupplements；
硫辛酸(alpha lipoic acid)，购自Swanson Vitamins；
复合维生素B(Vitamin B-Complex)，购自GNC；
蔗糖片，商购。
实施例1:组合物制备
按如下步骤制备实施例1的组合物：
(1)称取：5克食品级NMN；5克食品级硫辛酸；5克食品级复合维生素B；40克D-甘露醇；20克微晶纤维素；
(2)混匀压片：再加入0.5克硬脂酸镁，混匀，压片；
(3)包衣：用2.5克隔离包衣和8克肠溶包衣液；
(4)片剂包装。
实施例2:效果和副作用实验
供试品临床拟用方案
主要观察目的：抗衰老与不良反应。
剂量设计依据：
根据参考文献，NMN日用量最佳在250mg至1000mg之间。试验组试验组与对照组NMN日用量设置为500mg。试验组人群每日使用500mg的NMN，500mg的硫辛酸和500毫克的复合维生素B。对照组人群每日使用500mg的NMN。另设单服复合维生素B、单方硫辛酸各一组与试验组对比观察。
实验方法：
1)筛选和分组：45岁到65岁之间的个体随机分成五组。性别与年龄不做特殊考虑。实验人群中在一年内无任何突发性疾病及影响药物吸收和代谢的消化系统疾病。
2)给药方式：口服。
3)检测指标：实验人群在30天和60天内报告近期不良反应。
检测方法：实验分为五组：空白组、对照组1(单方NMN)、对照组2(单方硫辛酸)、对照组3(复合维生素B)和实验组。空白组每日服用蔗糖片，每日两次，每次两片。对照组1、2、3分别服用125毫克含量单方NMN胶囊、单方硫辛酸、单方复合维生素B，每日两次，每次两片。试验组服用NMN、硫辛酸和复合维生素B混合胶囊。每日两次，每次两片。
结果
1)一般临床观察：实验个体是否无不良反应和突发性疾病。
2)用量：对照组1和实验组都以500mg NMN为基础剂量，对照组2以500mg硫辛酸为基础剂量，对照组3以500mg复合维生素B为基础剂量。
3)具体结果如下：
参与实验的共93人。其中82人服用超过60天且给与记录反馈。实验人群年龄在45到65岁之间。分为空白组、对照组1(单方NMN)、对照组2(单方硫辛酸)、对照组3(复合维生素B)和试验组。完成情况：空白组入组11人，完成观察期10人；对照组1(单方NMN)入组13人，完成观察期11人；对照组2(单方硫辛酸)入组16人，完成13人；对照组3(复合维生素B)入组20人，完成观察期16人；实验组(复方NMN组)入组33人，完成观察期32人。在空白组中一人出现中度腹泻(经核查与服用试验药品无关)；对照组1中两人出现乏力，一人出现干呕，一人头晕，一人头痛(可忍受)；对照组2、对照组3和试验组中61位受观察者中无与服药有关的不适感和不良事件。在对照组1中出现乏力的两人在服用NMN60日后改为服用实验组合物，并再无乏力等不良反应。
结论：本试验条件下，NMN，硫辛酸和复合维生素B联合使用可消除单独使用NMN时所造成的副作用。
本发明不限于所述的特定方法、实验方案、动物研究和试剂，其可以改变。还可以理解的是在此所用的技术只是用于描述特定实施方案的目的，并不是来限制本发明的范围，其将只通过所附权利要求来限制。必须注意如在此和所附权利要求中所述的，单数形式“一种”和“该”包括复数指代物，除非文中另外清楚地指出。因此，例如，关于“一种化合物”包括多种这样的化合物及其本领域技术人员已知的等价物等。此外，术语“一种”，“一种或多种”和“至少一种”在此可以互换使用。还应该注意术语“含有”、“包括”和“具有”可以互换使用。除非另外限定，在此所用的所有技术和科学术语具有本发明所属领域的普通技术人员通常理解的相同意义。尽管与在此描述的那些相似或相等的任何方法和材料可以用于本发明的实践和测试中，现在将描述优选的方法和材料。将在此提及的所有出版物在此引入作为参考，用于描述和公开出版物中记载的可以与本发明结合使用的化学物质、动物、工具、统计学分析和方法的目的。在此没有将任何事物解释为承认本发明没有权利先于在先发明这样的公开。
Claims (10)
1.一种抗衰老组合物，其包含如下安全有效量的组分的复合物：烟酰胺单核苷酸、其药学上可接受的盐或它们的混合物；药学上可接受的复合维生素B；及硫辛酸、其药学上可接受的盐或它们的混合物。
2.根据权利要求1所述的抗衰老化合物，其中，基于100重量份的抗衰老组合物，所述硫辛酸的量为10-80重量份。
3.根据权利要求1所述的抗衰老化合物，其中，基于100重量份的抗衰老组合物，所述烟酰胺单核苷酸的量为10-80重量份。
4.根据权利要求1所述的抗衰老化合物，其中，基于100重量份的抗衰老组合物，所述复合维生素B的量为10-80重量份。
5.根据权利要求1所述的抗衰老化合物，其中，所述组合物还包括医学上可接受的添加剂。
6.根据权利要求5所述的抗衰老化合物，其中，所述添加剂为稀释剂、崩解剂、防腐剂和抗氧化剂中的至少一种。
7.一种用于抗衰老的保健食品，其包含根据权利要求1所述的抗衰老组合物。
8.根据权利要求1所述的抗衰老组合物在制备用于抗衰老的保健食品中的用途。
9.一种用于抗衰老的药物，其包含根据权利要求1所述的抗衰老组合物。
10.根据权利要求1所述的抗衰老组合物在制备用于抗衰老的药物中的用途。
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