CN113262237A - 一种agnm组合物及其制剂与应用 - Google Patents
一种agnm组合物及其制剂与应用 Download PDFInfo
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Abstract
本发明公开了一种AGNM组合物及其制剂与应用。所述的AGNM组合物是由虾青素、γ‑氨基丁酸和β‑烟酰胺单核苷酸组成。制剂为所述的AGNM组合物的制剂是在所述的ASBDV组合物中加入辅料制备成片剂、口服液、胶囊剂、颗粒剂、粉剂、丸剂、注射剂、膜剂或贴剂。应用为预防/改善/治疗失眠及相关疾病产品中的应用。本发明所述的AGNM组合物对压力、焦虑、失眠症状均有明显的改善效果;能显著提升认知功能(语言流利度和执行能力);改善皮肤质地和抗衰老,对皮肤有较好的保湿、抗皱、祛斑、减轻皮肤油腻、保持皮肤弹性的明显效果。AGNM组合物能有效激发抗衰老酶的基因活性,对与衰老相关的疾病(阿尔茨海默氏症,帕金森,血管性痴呆等)有潜在的防治效果。
Description
技术领域
本发明属于医药技术领域,具体涉及一种AGNM组合物及其制剂与应用。
背景技术
失眠(insomnia disorder)是第二大流行的精神疾病。世界卫生组织公布的数字显示,全球近1/4的人受失眠困扰,中国睡眠研究协会的调查发现,超过3亿中国人有睡眠障碍, 成年人失眠发生率高达38.2%。研究发现, 短时间睡眠可导致蓝斑神经元的抗氧化水平提高,长时间睡眠障碍会引起抗氧化与氧化系统失衡,从而出现过度氧化应激,造成神经元代谢紊乱及凋亡,加速人体衰老。长期睡眠障碍会引起肥胖、糖尿病、心血管疾病及免疫功能下降,诱发癌症、认知功能的损伤(如智力、记忆力和分析能力下降),,增加阿尔茨海默病等神经退行性疾病的患病率及死亡率。 随着老龄化社会的到来及中青年人工作和社会压力的增加,越来越多的人倾向于服用功能食品或膳食补充剂来改善睡眠,缓解压力。
发明内容
本发明的第一目的在于提供一种AGNM组合物;第二目的在于提供所述的AGNM组合物的制剂;第三目的在于提供所述的AGNM组合物的应用。
本发明的第一目的是这样实现的,所述的AGNM组合物是由虾青素和次大麻二酚组成。
本发明的第二目的是这样实现的,所述的AGNM组合物的制剂是在所述的ASBDV组合物中加入辅料制备成片剂、口服液、胶囊剂、颗粒剂、粉剂、丸剂、注射剂、膜剂或贴剂。
本发明的第三目的是这样实现的,所述的AGNM组合物在制备预防/改善/治疗失眠及相关疾病产品中的应用。
所述的AGNM组合物在制备美容产品中的应用。
所述的AGNM组合物在制备抗衰老产品中的应用。
虾青素(Astaxanthin,又名 3,3′-二羟基-4,4′ -二酮基-β,β′-胡萝卜素)是一种略带红色的 类胡萝卜素的化学物质,分子式C40H52O4,当前人类使用的天然虾青素来源于雨生红球藻,是迄今为止自然界中最强的天然抗氧化剂,其清除自由基能力是维生素E 和其他类胡萝卜素(叶黄素、番茄红素和β-类胡萝卜素)的500 倍之多,并且虾青素是目前发现唯一能穿透血-脑(Blood-Brain)、血-视网膜(Blood-Retina)屏障的类胡萝卜素。它具有增强机体免疫力、保护视网膜免受紫外辐射和光氧化、抗炎、预防血液低密度脂蛋白(LDL)-胆固醇的氧化损伤等功效,研究发现,富含虾青素的食物能提高睡眠效率。
γ-氨基丁酸(GABA)是是一种具有生物活性的重要功能性四碳非蛋白质氨基酸,是自然界中广泛分布的一种氨基酸,如番茄、马铃薯、南瓜和高丽菜等。在许多经过发酵或发芽的食品和谷类也含有GABA,如泡菜、 腌渍物、味噌、发芽米等。这些食物中GABA含量为27.5~74.5mg/100g。GABA(γ-Aminobutyric acid) 是负责让脑神经放松休息的神经传递物质,在改善应激及情绪紊乱方面具有重要作用,摄入GABA可以提高葡萄糖磷脂酶的活性,促进大脑的能量代谢,增加脑血流量和氧供给量,改善神经机能,从而达到改善睡眠和易怒症状等功效。
烟酰胺单核苷酸(Nicotinamide mononucleotide,NMN)是维生素B3(烟酰胺)的一种衍生物,分子量为334.221g/mol。NMN存在两种差向异构体:α型和β型。但只有β型NMN具有生物活性。NMN天然存在于各种食物中,比如 牛油果、番茄中分别含有0.36-1.6mg和0.26-0.3mg NMN,而每100g生牛肉中仅含有0.06-0.42mg NMN[5]。NMN的主要作用是作为人体内NAD+生物合成的中间体,研究发现NAD+水平随着年龄的增加稳定地衰减,导致代谢的改变和疾病易感性的增加;在年老或疾病动物中恢复NAD+水平能促进健康和延长寿命。临床前研究表明,NMN在心脏和脑缺血、阿尔茨海默病、饮食和年龄引起的2型糖尿病和肥胖症中具有多种药理作用,这些都与NAD+的缺乏有关。
根据目前的文献报道,NMN具有如下功效:
1. 支持NAD+产生
2. 激活SIRTUINS
3. 修复DNA损伤
4. 支持新陈代谢,促进能量产生
5.促进血管再生、保持血管弹性,增强耐力和活力
6. 帮助体重管理
7. 促进心脏健康
8. 促进大脑健康
9. 改善胰岛素敏感性
10. 防止骨密度下降、改善视力和免疫功能
其中NMN的安全性评价,药代动力学及改善糖尿病前期肌肉胰岛素敏感性已完成人体实验,得到了较好的实验结果 。
本发明所述的AGNM组合物对压力相关症状和认知功能有积极影响,服用所述的AGNM组合物4周后,具有以下效果:
1、与压力有关的症状(抑郁、焦虑和失眠)都明显减轻,认知功能(即口语流利度和执行能力)都明显得到提升;
2、能改善皮肤质地,对皮肤有较好的保湿、抗皱、祛斑、减轻皮肤油腻,保持皮肤弹性具有明显的效果;
3、能有效激发抗衰老酶的基因活性,有效延缓衰老,对与衰老相关的免疫功能降低,认知和记忆功能下降,糖尿病,心血管疾病及神经退行性疾病(阿尔茨海默氏症,帕金森,血管性痴呆等)有潜在的防治效果。
附图说明
图1为本发明所述的AGNM组合物服用四周后对压力作用效果示意图;
图2为本发明所述的AGNM组合物服用四周后对焦虑作用效果示意图;
图3为本发明所述的AGNM组合物服用四周后对睡眠状况作用效果示意图;
图4为本发明所述的AGNM组合物服用四周后对语言流利度作用效果示意图;
图5为本发明所述的AGNM组合物服用四周后对执行能力作用效果示意图;
图6为本发明所述的AGNM组合物对皱纹的改善效果示意图;
图7为本发明所述的AGNM组合物对皮肤弹性、皮脂油和失水率的改善效果示意图;
图8为本发明所述的AGNM组合物对老年斑的改善效果示意图;
图9为本发明所述的AGNM组合物对个体的抗衰老基因指数影响示意图;
图10为通过补充本发明所述的AGNM组合物,提高了体内NAD+含量,有效激发抗衰老酶基因活性示意图;
图11为通过阶段性补充所述的AGNM组合物,无法起到持续激活抗衰老酶基因的效果;停止补充GNM后,抗衰老酶基因活性随之降低示意图。
具体实施方式
下面结合实施例和附图对本发明作进一步的说明,但不以任何方式对本发明加以限制,基于本发明教导所作的任何变换或替换,均属于本发明的保护范围。
本发明所述的AGNM组合物是由虾青素、γ-氨基丁酸和β-烟酰胺单核苷酸组成。
所述的AGNM组合物是由重量份的虾青素1~50份、γ-氨基丁酸50~3000份和β-烟酰胺单核苷酸100~2000份组成。
所述的AGNM组合物是由重量份的虾青素1~24份、γ-氨基丁酸50~2000份和β-烟酰胺单核苷酸100~1000份组成。
所述的AGNM组合物是由重量份的虾青素5~15份、γ-氨基丁酸500~1000份和β-烟酰胺单核苷酸400~600份组成。
所述的AGNM组合物是由重量份的虾青素8~12份、γ-氨基丁酸500~700份和β-烟酰胺单核苷酸400~500份组成。
本发明所述的AGNM组合物的制剂为所述的AGNM组合物的制剂是在所述的ASBDV组合物中加入辅料制备成片剂、口服液、胶囊剂、颗粒剂、粉剂、丸剂、注射剂、膜剂或贴剂。
本发明所述的AGNM组合物的应用为所述的AGNM组合物在制备预防/改善/治疗失眠及相关疾病产品中的应用。
本发明所述的AGNM组合物的应用为所述的AGNM组合物在制备美容产品中的应用。
本发明所述的AGNM组合物的应用为所述的AGNM组合物在制备抗衰老产品中的应用。
所述的产品为药品、保健食品、食品或日用化妆品等。
下面以具体实施案例对本发明做进一步说明:
实施例1
称量虾青素1mg、γ-氨基丁酸50mg和β-烟酰胺单核苷酸100mg混匀得到目标物AGNM组合物。
实施例2
称量虾青素5mg、γ-氨基丁酸500mg和β-烟酰胺单核苷酸400 mg混匀得到目标物AGNM组合物。
实施例3
称量虾青素8mg、γ-氨基丁酸700mg和β-烟酰胺单核苷酸500mg混匀得到目标物AGNM组合物。
实施例4
称量虾青素12mg、γ-氨基丁酸1000mg和β-烟酰胺单核苷酸600 mg混匀得到目标物AGNM组合物。
实施例5
称量虾青素15mg、γ-氨基丁酸2000mg和β-烟酰胺单核苷酸1000 mg混匀得到目标物AGNM组合物。
实施例6
称量虾青素24mg、γ-氨基丁酸3000mg和β-烟酰胺单核苷酸2000 mg混匀得到目标物AGNM组合物。
实施例7
称量虾青素50mg、γ-氨基丁酸3000mg和β-烟酰胺单核苷酸2000 mg混匀得到目标物AGNM组合物。
实施例8
称量虾青素50mg、γ-氨基丁酸50mg和β-烟酰胺单核苷酸1000mg混匀得到目标物AGNM组合物。
实施例9
称量虾青素40mg、γ-氨基丁酸2500mg和β-烟酰胺单核苷酸1500 mg混匀得到目标物AGNM组合物。
实施例10
以实施例2制备得到的AGNM组合物中加入药学上可接受的辅料制备成片剂。
实施例11
以实施例4制备得到的AGNM组合物中加入药学上可接受的辅料制备成口服液。
实施例12
以实施例5制备得到的AGNM组合物中加入药学上可接受的辅料制备成胶囊剂。
实施例13
以实施例7制备得到的AGNM组合物中加入药学上可接受的辅料制备成颗粒剂。
实施例14
以实施例9制备得到的AGNM组合物中加入药学上可接受的辅料制备成粉剂。
实施例15
以实施例1制备得到的AGNM组合物中加入药学上可接受的辅料制备成丸剂。
实施例16
以实施例3制备得到的AGNM组合物中加入药学上可接受的辅料制备成注射剂。
实施例17
以实施例8制备得到的AGNM组合物中加入药学上可接受的辅料制备成膜剂。
实施例18
以实施例1制备得到的AGNM组合物中加入药学上可接受的辅料制备成贴剂。
实施例19
以实施例3制备得到的AGNM组合物进行试验,具体如下:
(一)实施例3制备得到的AGNM组合物对睡眠的改善实验
1、实验目的
通过随机、安慰剂对照、交叉和双盲实验,检查成年人中口服实施例3制备得到的AGNM组合物4周,对压力相关症状和认知的功效的影响。
2、实验方法
参加者共50人,在参加功能性验证的有效成员中,主要集中在女性、31~50岁、PSQI在6~15的体验者,其中,女性占总人数的86.7%,31~50岁的人占83.3%,睡眠质量一般和较差的占96.6%。每天睡前口服实施例3制备得到的AGNM组合物(500mg)和安慰剂(本次实验用的实施例3制备得到的AGNM组合物由云南维他源生物科技有限公司提供),连续服用4周,通过华为手环监测受试者的睡眠时间,并用匹茨堡睡眠质量指数量表(PSQI)和问卷表单让体验者反馈睡眠变化。
3、实验结果
3.1参加功能性验证的有效成员基本情况分布
注:PSQI总分为21分,得分越高,表示睡眠质量越差。PSQI总分和睡眠质量定义如下:“6~10分”表示睡眠质量较好,“11~15分”表示睡眠质量一般,“16~21分”表示睡眠质量很差。
服用实施例3制备得到的AGNM组合物4周后对压力、焦虑、睡眠、语言流利度和执行能力的改善效果见图1、图2、图3、图4和图5,结果显示服用实施例3制备得到的AGNM组合物4周后,压力、焦虑、睡眠状况均有明显的减轻;认知功能(语言流利度和执行能力)均有明显提升。
(二)实施例3制备得到的AGNM组合物的美容效果
1、实验方法
实验分为两个组,AGNM组共50人(20-60岁,30名女性,20名男性),每天睡前口服实施例3制备得到的AGNM组合物(500mg),安慰剂组44人(20-60岁,25名女性,19名男性),连续服用4周,本次实验用的实施例3制备得到的AGNM组合物由云南维他源生物科技有限公司提供),测量参数: 皱纹,弹性,老年斑,皮肤质地(纹路数量-深度-体积),水分,失水量(TEWL),测量时间点为第4周。
2、实验结果
2.1 对皱纹的改善效果(见图6),图中:(A) 实施例3制备得到的AGNM组合物和安慰剂组皱纹最深点无显著差异(p>0.05);(B)实施例3制备得到的AGNM组合物和安慰剂组最深处皱纹的平均深度无明显差异(p>0.05);(C) 实施例3制备得到的AGNM组合物和安慰剂组皱纹最深处的最大宽度无明显差异(p>0.05);(D) 实施例3制备得到的AGNM组合物与安慰剂组相比,AGNM治疗组皱纹的面积比明显下降(*p<0.05);(E)治疗4周后,两组所有皱纹的平均深度没有差异(p>0.05);(F) 实施例3制备得到的AGNM组合物与安慰剂组相比,AGNM治疗组皱纹的体积比明显下降(*p<0.05)。
2.2 对皮肤弹性、皮脂油和失水率的改善效果(见图7),图中:(A) 实施例3制备得到的AGNM组合物和安慰剂组皮肤弹性明显不同(*p<0.05),实施例3制备得到的AGNM组合物明显改善了皮肤的弹性;(B) 实施例3制备得到的AGNM组合物和安慰剂组皮脂油出现了差异(*p<0.05), 实施例3制备得到的AGNM组合物使皮脂油减少;(C) 实施例3制备得到的AGNM组合物对皮肤有明显保湿效果(*p<0.05)。
2.3 对老年斑的改善效果(见图8),图中:(A,C)使用实施例3制备得到的AGNM组合物前,皮肤的老年斑点状态; (B,D) 实施例3制备得到的AGNM组合物治疗后老年斑点数量明显下降((*p<0.05));(E) 实施例3制备得到的AGNM组合物和安慰剂组 4周后皮肤斑点数量有明显差异(*p<0.05)。
结论:口服实施例3制备得到的AGNM组合物4周能改善皮肤质地和抗衰老,对皮肤有较好的保湿、抗皱、祛斑、减轻皮肤油腻、保持皮肤弹性具有明显的效果。
(三)实施例3制备得到的AGNM组合物对抗衰老酶基因指数的影响
Sirtuins白家族是一类高度保守的烟酰胺腺嘌呤双核苷酸(nicotinamideadenine dinucleotide, NAD+)依赖的去乙酰化酶(histonedeacetylase, HDAC),又称抗衰老酶. Sirtuins蛋白通过调节细胞核、细胞质和线粒体中的多种蛋白质,发挥广泛的生物学功能。在动物实验中,最新研究进展表明Sirtuins参与DNA修复、代谢、炎症反应、端粒酶、细胞存活、细胞分化和干细胞等一系列细胞生命过程,对于许多人类疾病的研究,如年龄相关疾病的研究具有重要的启示意义.
1、抗衰老酶基因检测用于AGNM的评估
选取30名健康人,男性18人,女性12人。每日补充500mg 实施例3制备得到的AGNM组合物,持续2周,服用前后分别检测抗衰老酶基因指数。本次采用可帮医学独家研发的抗衰老酶基因检测采集2毫升血液,检测外周血中Sirtuins基因mRNA表达丰度,从而实现抗衰老酶基因活性的动态监测。
结果(见图9),Paired t-test 统计检验显示:服用前后抗衰老酶基因指数存在显著差异,具有统计学意义(P< 0.0001)。长期服用实施例3制备得到的AGNM组合物能有效激发抗衰老酶基因活性,有潜在的抗衰老的效果。
服用案例1:
男性,60+,每天补充 500 mg 实施例3制备得到的AGNM组合物,服用前抗衰老酶指数处于稳定水平;服用后抗衰老酶指数持续升高,服用60天后抗衰老酶指数升高至5.2(见图10)。
服用案例2:
女性,30+,每天补充 500mg AGNM,服用前抗衰老酶指数处于稳定水平,服用30天后抗衰老酶指数升高至4.9,停用15天,抗衰老酶指数下降至3.1(见图11)。
实施例20
分别以实施例1、实施例2、实施例4、实施例5、实施例6、实施例7、实施例8、实施例9进行实验,方法同实施例19,结果均表明本发明所述的AGNM组合物服用4周后,压力、焦虑、睡眠状况均有明显的减轻;认知功能(语言流利度和执行能力)均有明显提升;能改善皮肤质地和抗衰老,对皮肤有较好的保湿、抗皱、祛斑、减轻皮肤油腻、保持皮肤弹性具有明显的效果。长期服用所述的AGNM组合物能有效激发抗衰老酶的基因活性,有效延缓衰老,对与衰老相关的免疫功能降低,认知和记忆功能下降,糖尿病,心血管疾病及神经退行性疾病(阿尔茨海默氏症,帕金森,血管性痴呆等)有潜在的防治效果。
Claims (9)
1.一种AGNM组合物,其特征在于,所述的AGNM组合物是由虾青素、γ-氨基丁酸和β-烟酰胺单核苷酸组成。
2.根据权利要求1所述的AGNM组合物,其特征在于,所述的AGNM组合物是由重量份的虾青素1~50份、γ-氨基丁酸50~3000份和β-烟酰胺单核苷酸100~2000份组成。
3.根据权利要求1所述的AGNM组合物,其特征在于,所述的AGNM组合物是由重量份的虾青素1~24份、γ-氨基丁酸50~2000份和β-烟酰胺单核苷酸100~1000份组成。
4.根据权利要求1所述的AGNM组合物,其特征在于,所述的AGNM组合物是由重量份的虾青素5~15份、γ-氨基丁酸500~1000份和β-烟酰胺单核苷酸400~600份组成。
5.根据权利要求1所述的AGNM组合物,其特征在于,所述的AGNM组合物是由重量份的虾青素8~12份、γ-氨基丁酸500~700份和β-烟酰胺单核苷酸400~500份组成。
6.一种权利要求1~5任一所述的AGNM组合物的制剂,其特征在于,所述的AGNM组合物的制剂是在所述的ASBDV组合物中加入辅料制备成片剂、口服液、胶囊剂、颗粒剂、粉剂、丸剂、注射剂、膜剂或贴剂。
7.一种权利要求1~5任一所述的AGNM组合物的应用,其特征在于,所述的AGNM组合物在制备预防/改善/治疗失眠及相关疾病产品中的应用。
8.一种权利要求1~5任一所述的AGNM组合物的应用,其特征在于,所述的AGNM组合物在制备美容产品中的应用。
9.一种权利要求1~5任一所述的AGNM组合物的应用,其特征在于,所述的AGNM组合物在制备抗衰老产品中的应用。
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