CN112972464A - 一种含有褪黑素和水飞蓟提取物的组合物及其在助眠和护肝上的应用 - Google Patents
一种含有褪黑素和水飞蓟提取物的组合物及其在助眠和护肝上的应用 Download PDFInfo
- Publication number
- CN112972464A CN112972464A CN202110292238.6A CN202110292238A CN112972464A CN 112972464 A CN112972464 A CN 112972464A CN 202110292238 A CN202110292238 A CN 202110292238A CN 112972464 A CN112972464 A CN 112972464A
- Authority
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- China
- Prior art keywords
- melatonin
- extract
- silybum marianum
- composition
- herba silybi
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
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Classifications
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- A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
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- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
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Abstract
本发明公开了一种组合物,组合物含有褪黑素和水飞蓟提取物,能够更好的帮助睡眠,有效缓解睡醒后的乏力和疲劳感,提高睡眠质量;另外组合物在护肝、抗疲劳、抗抑郁也有良好的应用。
Description
技术领域
本发明涉及一种组合物,具体涉及一种含有褪黑素和水飞蓟提取物的组合物及其应用。
背景技术
褪黑素主要是由哺乳动物和人类的松果体产生的一种胺类激素,又称为美拉酮宁、抑黑素、松果体素,是存在于从藻类到人类等众多生物中的一种荷尔蒙。褪黑素的分泌是有昼夜节律的,一般在凌晨2-3点达到高峰。夜间褪黑素水平的高低直接影响到睡眠的质量。随着年龄的增长,特别是35岁以后,体内自身分泌的褪黑素明显下降,平均每10年降低10-15%,导致睡眠紊乱以及一系列功能失调,而褪黑素水平降低、睡眠减少是人类脑衰老的重要标志之一。因此,从体外补充褪黑素,可使体内的褪黑素水平维持在年轻状态,调整和恢复昼夜节律。
但部分褪黑素使用人群反馈使用褪黑素能够有助于入睡,但睡眠中体温过低、进而睡醒后有头晕、乏力和疲劳感,反馈睡眠质量较差。
drugs网站也公布了褪黑素的副作用,其实最常见的副作用就是白天的的疲劳乏力和低落的心情。
水飞蓟为一年生或两年生草本植物,又称奶蓟草,原生于南欧和北非等地,在欧洲和非洲有几千年的栽培和使用历史,为民间药用植物。水飞蓟被广泛用作治疗肝脏疾病和心血管疾病的药物。
水飞蓟提取物以水飞蓟Silybummarianum的干燥果实为原料,商品提取物通常标化为含总水飞蓟素80%。水飞蓟素是多酚类的复杂混合物,包括七种关系密切的黄酮醇-木质素加成物(水飞蓟宾A、水飞蓟宾B、异水飞蓟宾A、异水飞蓟宾B、水飞蓟亭、异水飞蓟亭及水飞蓟宁)和一种类黄酮黄杉素(taxifolin)。水飞蓟宾是水飞蓟素的半纯化部分,主要是两种非对映异构体(水飞蓟宾A和水飞蓟宾B)的混合物,其比例大约为1:1。水飞蓟宾混合物表现出多种药理作用,尤其是在肝脏中,并且有一些临床证据表明水飞蓟宾可作为酒精和儿童“A”级肝硬化的支持元素。
US4764508A发明专利申请中涉及包含水飞蓟宾,水飞蓟素和水飞蓟宾与磷脂的亲脂性复合物的新型化合物,以及通过非常规方法制备这些复合物的方法。新化合物在胃肠道的吸收明显更大,导致血浆水平高于单独的黄烷醇。所得到的药代动力学和药理学参数的改善使得该物质可以有利地用于治疗具有毒性,代谢或感染性或变性性质的急性和慢性肝病。
US20140179773A1中公开了水飞蓟宾能够有助于提高心肌损伤和心肌细胞功能改善的有效性。IN2579CHE2007A中采用水飞蓟提取物起到预防,减轻,或治疗心血管疾病,以达到所述最低可能的心脏危险的。
另外睡眠较差容易诱发肝脏疾病,改善睡眠也有助于肝脏健康。
发明内容
本发明的目的在于针对现有技术的不足之处,提供一种组合物,含有褪黑素类的成分和水飞蓟提取物或其衍生物、或其盐。
进一步的,褪黑素类成分包括褪黑素本身以及褪黑素衍生物,如褪黑素形成的酸、酯、盐,例如氨基酸修饰的褪黑素,以及能够进行分解和代谢形成褪黑素的物质,褪黑素前体,例如5-羟色胺;以及其组合。
进一步的,褪黑素为生物中提取的天然褪黑素,进一步的可以为动物、植物、微生物中提取的褪黑素,在另一个实施方式中,该褪黑素可以为合成的。
进一步的,褪黑素的纯度为纯度为10%以上,具有20%以上、30%以上、40%以上、50%以上、60%以上、70%以上、80%以上、90%以上、95%以上、96%以上、97%以上、98%以上、99%以上或100%。
进一步的,水飞蓟提取物包括水飞蓟宾A、水飞蓟宾B、异水飞蓟宾A、异水飞蓟宾B、水飞蓟亭、异水飞蓟亭、水飞蓟宁、黄杉素中的一种或多种;进一步优选的,水飞蓟提取物包括水飞蓟宾A和其他类型水飞蓟提取物的组合。
进一步的,水飞蓟提取物为水飞蓟提取物微胶囊形式和/或水飞蓟提取物脂质体形式和/或水飞蓟提取物自微乳化形式,优选为水飞蓟提取物-磷脂的形式、水飞蓟提取物-磷脂-胆固醇的形式、水飞蓟提取物-环糊精的形式的一种或多种。
进一步,优选为水飞蓟提取物-磷脂-胆固醇的脂质体形式和水飞蓟提取物-磷脂复合物的形式复配,或为飞蓟提取物-磷脂-胆固醇的脂质体形式和水飞蓟提取物-环糊精的形式复配。
进一步的,组合物中水飞蓟提取物1-99.9份,褪黑素0.1-99份;进一步的,组合物中水飞蓟提取物20-99.25份,褪黑素0.25-80份;进一步的,组合物中水飞蓟提取物80-99.7份,褪黑素0.3-20份;进一步的,组合物中水飞蓟提取物98-99.6份,褪黑素0.4-2份。
进一步的,组合物中水飞蓟提取物1-99.9%(w/w),褪黑素0.1-99%(w/w);进一步的,组合物中水飞蓟提取物20-99.25%(w/w),褪黑素0.25-80%(w/w);进一步的,组合物中水飞蓟提取物80-99.7%(w/w),褪黑素0.3-20%(w/w);进一步的,组合物中水飞蓟提取物98-99.6%(w/w),褪黑素0.4-2%(w/w)。
进一步的,含有组合物为褪黑素类的成分和水飞蓟提取物或其衍生物、或其盐的产品中水飞蓟提取物1-99.9%(w/w),褪黑素0.1-99%(w/w);进一步的,产品中水飞蓟提取物20-99.25%(w/w),褪黑素0.25-80%(w/w);进一步的,产品中水飞蓟提取物80-99.7%(w/w),褪黑素0.3-20%(w/w);进一步的,产品中水飞蓟提取物98-99.6%(w/w),褪黑素0.4-2%(w/w)。
进一步的,含有组合物为褪黑素类的成分和水飞蓟提取物或其衍生物、或其盐的产品中水飞蓟提取物1-1000mg,褪黑素0.01-99mg;进一步的,产品中水飞蓟提取物20-600mg,褪黑素0.05-80mg;进一步的,产品中水飞蓟提取物25-195mg,褪黑素0.25-3mg。
进一步的,水飞蓟提取物中的水飞蓟宾(水飞蓟宾A和水飞蓟宾B)占水飞蓟宾A、水飞蓟宾B、异水飞蓟宾A、异水飞蓟宾B、水飞蓟亭、异水飞蓟亭、水飞蓟宁、黄杉素总含量的20%以上,具有为30%以上、40%以上、50%以上、60%以上、70%以上、80%以上、90%以上、95%以上、96%以上、97%以上、98%以上、99%以上或100%。
进一步的,水飞蓟提取物的纯度为50%以上,具有60%以上、70%以上、80%以上、90%以上、95%以上、96%以上、97%以上、98%以上、99%以上或100%。
本发明还提供了一种产品,包括上述组合物,所述产品剂型为注射液、口服液、片剂、硬胶囊、软胶囊、糖果、固体饮料、液体饮料、膏滋中的一种。
本发明产品优选为软胶囊,以植物油为载体,以软胶囊为壳体,承载褪黑素和水飞蓟提取物。在另一个实施例中,本发明产品优选为,凝胶糖果质地,以果胶、明胶或黄原胶等可食用凝胶为壳体,以褪黑素和水飞蓟提取物为夹心,或以承载着褪黑素和水飞蓟提取物的芯料为夹心。
进一步的,所述产品还包括辅料;其中辅料包括:水、赋形剂、色素、甜味剂、pH调节剂、增稠剂、粘合剂、崩解剂、填充剂。
进一步的,产品中的褪黑素类的成分的含量为每粒0.1mg-10mg、每片0.1mg-10mg、每瓶0.1mg-10mg、每袋0.1mg-10mg。
本发明还提供了组合物在助眠类药品、保健食品、膳食补充剂和食品中的应用;
或/和在肝损伤类药品、保健食品、膳食补充剂和食品中的应用;
或/和在护肝类药品、保健食品、膳食补充剂和食品中的应用;
或/和在心脏保护类的药品、保健食品、膳食补充剂和食品中的应用;
或/和在抗抑郁和抗焦虑的药品、保健食品、膳食补充剂和食品中的应用。
本发明功能上的有益效果:
对于助眠,褪黑素水平的高低直接影响到睡眠的质量,但外源性褪黑素摄入过多,或者使用者对褪黑素敏感,容易造成体温低,部分褪黑素使用者会寒冷,进而睡醒后有头晕感和疲劳感,反馈睡眠质量较差。对于长期睡眠质量差的人群,具有长期使用褪黑素的习惯;有褪黑素的长期使用的用户反馈使用褪黑素,同时使用水飞蓟产品能够进一步提升睡眠质量。发明人对此进一步研究,发明人发现,水飞蓟提取物能够有效缓解因外源性褪黑素的摄入造成的体温降低,尤其是对于过量外源性摄入褪黑素时,或者对褪黑素敏感的个体摄入褪黑素时,造成的体温降低,进而有效提高睡眠质量,有效缓解睡醒后的乏力和疲劳感。
对于护肝作用:水飞蓟提取物清除干细胞内活性氧自由基,稳定肝细胞膜,保护肝脏。而褪黑素的添加,使得人体睡眠质量提升进而有利于肝脏的修复。
另外飞蓟提取物清除自由基、稳定细胞膜、修复细胞;褪黑素可调节人体生物钟和体内代谢和激素水平。组合物可以更好的清除细胞内活性氧自由基、抗炎、修复受损组织和稳定人体情绪。因此组合物在抗疲劳作用、抗抑郁和焦虑作用上也有很好的表现和应用前景。
本发明剂型上的有益效果:
水飞蓟宾的化学结构为
褪黑素类成分和水飞蓟提取物及其衍生物、盐,都是更偏向油溶性原料,在制备制剂时,无需考虑相容性问题和分层问题、稳定性问题等,尤其是制备为复合物、脂质体等,产品稳定性更好。以植物油作为载体进行载褪黑素类成分和水飞蓟提取物,采用软胶囊或者凝胶作为外壳,产品性质稳定。
术语解释:本发明所用的“褪黑素类的成分”,为褪黑素本身以及褪黑素衍生物,如褪黑素形成的酸、酯、盐,以及能够进行分解和代谢形成褪黑素的物质;
本文所用的“产品”,在未标明的情况下,表达的为褪黑素类的成分和水飞蓟提取物或其衍生物、或其盐为功能成分的产品。
具体实施方式
为了便于本领域技术人员的理解,下面结合实施例对本发明作进一步的说明,实施方式提及的内容并非对本发明的限定。
实施例1
一种组合物,含有褪黑素和水飞蓟提取物,水飞蓟提取物为水飞蓟提取物100mg,褪黑素1mg。
实施例2
一种组合物,含有褪黑素和水飞蓟提取物,水飞蓟提取物为水飞蓟提取物200mg,褪黑素0.5mg。
实施例3
一种组合物,含有褪黑素和水飞蓟提取物,水飞蓟提取物为水飞蓟提取物50mg,褪黑素3mg。
实施例4
一种组合物,含有褪黑素和水飞蓟提取物,水飞蓟提取物为水飞蓟提取物20mg,褪黑素2mg。
实施例5
一种组合物,含有褪黑素和水飞蓟提取物,水飞蓟提取物为水飞蓟提取物120mg,褪黑素1mg。
实施例6
一种组合物,含有褪黑素和水飞蓟提取物,水飞蓟提取物为水飞蓟提取物10mg,褪黑素0.5mg。
实施例7
一种组合物,含有褪黑素和水飞蓟提取物,水飞蓟提取物为水飞蓟提取物100mg,褪黑素1mg。水飞蓟提取物为脂质体形式。
实施例8
一种组合物,含有褪黑素和水飞蓟提取物,水飞蓟提取物为水飞蓟提取物100mg,褪黑素1mg。水飞蓟提取物为脂质体形式。褪黑素为氨基酸修饰的褪黑素。
实施例9
一种组合物,含有氨基酸修饰的褪黑素和水飞蓟提取物,水飞蓟提取物为水飞蓟提取物100mg,氨基酸修饰的褪黑素1mg。水飞蓟提取物为脂质体形式。褪黑素为氨基酸修饰的褪黑素。
实施例10
一种组合物,含有褪黑素和水飞蓟提取物,水飞蓟提取物为水飞蓟提取物125mg,褪黑素1mg。水飞蓟提取物为脂质体形式。
实施例11
一种软胶囊,软胶囊内容物中含有褪黑素和水飞蓟提取物,水飞蓟提取物125mg,褪黑素1mg。还有适应量的大豆油和维生素E和维生素B6。
实施例12
一种夹心凝胶糖果,夹心内容物中含有褪黑素和水飞蓟提取物,水飞蓟提取物125mg,褪黑素1mg。还有适应量的黄原胶和维生素E和维生素B6。
实施例13
一种硬胶囊,软胶囊内容物中含有褪黑素和水飞蓟提取物,还有淀粉和硬脂酸镁。水飞蓟提取物125mg,褪黑素1mg。
清洁级Wistar大鼠32只,体重190-210g,雌雄各半,大鼠于试验前1周饲养于室温(20±2)℃,给予日常鼠粮和蒸馏水饲养,不限制进食量及饮水量。人工光照周期下动物房内,光照条件如下:明暗比为15h:9h,开灯时间为早6:00:关灯时间为晚21:00,试验中分为四组,分别为对照组,褪黑素组、水飞蓟组、褪黑素+水飞蓟组,每组8只,关灯前灌喂大鼠,褪黑素组灌喂褪黑素,灌喂量为0.4mg褪黑素,约为2mg/(kg.bw),并灌喂100mg生理盐水;水飞蓟组灌喂水飞蓟,灌喂量为50mg水飞蓟提取物,约为0.25g/(kg.bw),并灌喂100mg生理盐水;褪黑素+水飞蓟组灌喂褪黑素+水飞蓟提取物,灌喂量为0.4mg褪黑素,约为2mg/(kg.bw)和50mg水飞蓟提取物,约为0.25g/(kg.bw),并灌喂50mg生理盐水;;空白组灌喂100mg生理盐水。
灌喂半小时后,全部实验组大鼠处于入眠状态,测量半小时(21:30)、两小时(23:00)、六小时(3:00)、九小时(6:00)后的小鼠体温。
测量大鼠体温的方式为:先对非接触式红外测温仪进行校准,测量时将尾巴轻轻提起,露出肛门,采用非接触式红外测温仪对准大鼠肛门,枪口与肛门5cm左右测量肛门温度。
表1不同逐步体温随时间变化的情况mean±SD(n=8),单位℃
由表1可知,大鼠随时睡眠的时间的持续,体温呈现出先降低,后升高的趋势;体温在入睡后6小时达到最低(每组的六小时体温与半小时体温均有显著性差异,p<0.05);对比不同组别入眠六小时的大鼠体温,对于褪黑素组体温降低最多,体温平均值相当于半小时的体温降低0.63℃。褪黑素组入眠六小时的大鼠体温平均值低相当于空白组0.28℃(p<0.05);Kunz et al.Melatonin in Patients with Reduced REM Sleep Duration:TwoRandomized Controlled Trials J Clin Endocrinol Metab,January2004,89(1):128-134,该文献中也报道采用临床试验,在凌晨5点左右,人体体温达到最低;而摄入褪黑素的在睡眠到凌晨5点时体温相对于正常组体温的更低。
而相对于褪黑素+水飞蓟组入眠六小时的体温平均值,相当于空白组入眠六小时的大鼠体温平均值低0.2℃(p<0.05,有显著性差异)。另一方面单独灌喂水飞蓟提取物入眠六小时的体温与空白组入眠六小时的体温并没有显著性差异(p>0.05)。也就是说,在灌喂褪黑素同时灌喂水飞蓟提取物能够显著的改善了大量灌喂大鼠褪黑素时的体温过低的情况。
夜晚睡眠期间相对较低的体温,有助于人体进行代谢,如肝脏夜间代谢和脑部信息整理;但体温过低时,影响体内的酶活力,即为使得代谢所需的酶活力下降,使得夜晚代谢过低,无法保证夜晚代谢效率,容易造成睡醒后的困倦和乏力。
褪黑素在体内的代谢情况,在肝脏中代谢较快,而在褪黑素在脑中是起到镇静助眠的作用,而褪黑素在脑的代谢速度一般(褪黑素的体内过程,付爱玲等,医药导报1999年6月第81卷第3期),而水飞蓟能够显著的增加肝脏代谢速度,因此有助于降低褪黑素对机体的副作用,尤其是敏感人群的副作用,改善睡醒后的疲劳感。
对于易失眠人群摄入褪黑素以促进睡眠,虽然人体对外源性褪黑素的敏感下降,褪黑素的助眠效果降低会促使该人群更大剂量的摄入褪黑素,大量服用褪黑素时带来的睡眠体温过低,睡醒后有头晕、乏力和疲劳感的问题,采用褪黑素和水飞蓟组合使用,可以显著改善睡眠。从经常服用褪黑素的用户中筛选出若干服用褪黑素后虽然可以睡着但清醒后有疲劳乏力感的志愿者,将水飞蓟提取物和褪黑素同时使用,也反馈对起床清醒后的状态有很大的改善。发明人将进一步筛选出一批志愿者,进而能够进行统计人体临床试验。
另外,水飞蓟具有清除干细胞内活性氧自由基,稳定肝细胞膜,保护肝脏的效果;水飞蓟提取物与褪黑素的组合,使得人体睡眠质量提升进而也有利于肝脏的修复。
本技术领域技术人员可以理解,除非另外定义,这里使用的所有术语(包括技术术语和科学术语),具有与本发明所属领域中的普通技术人员的一般理解相同的意义。还应该理解的是,诸如通用字典中定义的那些术语,应该被理解为具有与现有技术的上下文中的意义一致的意义,并且除非像这里一样被特定定义,否则不会用理想化或过于正式的含义来解释。
应当理解,以上借助优选实施例对本发明的技术方案进行的详细说明是示意性的而非限制性的。本领域的普通技术人员在阅读本发明说明书的基础上可以对各实施例所记载的技术方案进行修改,或者对其中部分技术特征进行等同替换;而这些修改或者替换,并不使相应技术方案的本质脱离本发明各实施例技术方案的精神和范围。
Claims (10)
1.一种组合物,其特征在于:含有褪黑素类的成分和水飞蓟提取物或其衍生物、或其盐。
2.根据权利要求1所述组合物,其特征在于:水飞蓟提取物包括水飞蓟宾A、水飞蓟宾B、异水飞蓟宾A、异水飞蓟宾B、水飞蓟亭、异水飞蓟亭、水飞蓟宁、黄杉素中的一种或多种组合。
3.根据权利要求1所述组合物,其特征在于:水飞蓟提取物为水飞蓟提取物微胶囊形式和/或水飞蓟提取物脂质体形式和/或水飞蓟提取物自微乳化形式,优选为水飞蓟提取物-磷脂的形式、水飞蓟提取物-磷脂-胆固醇的形式、水飞蓟提取物-环糊精的形式的一种或多种;进一步优选为水飞蓟提取物-磷脂-胆固醇的脂质体形式和水飞蓟提取物-磷脂复合物的形式复配,或为飞蓟提取物-磷脂-胆固醇的脂质体形式和水飞蓟提取物-环糊精的形式复配。
4.根据权利要求1的所述组合物,其特征在于:褪黑素类的成分包括褪黑素、褪黑素前体、以及褪黑素形成的酸、酯、盐及其组合。
5.根据权利要求1的所述组合物,其特征在于:褪黑素类的成分包括合成的褪黑素、生物分离的褪黑素,进行了修饰的生物分离的褪黑素及其组合。
6.根据权利要求1的所述组合物,其特征在于:水飞蓟提取物中的水飞蓟宾占水飞蓟提取物的量为20%以上,优选为30%以上、40%以上、50%以上、60%以上、70%以上、80%以上、90%以上、95%以上、96%以上、97%以上、98%以上、99%以上或100%。
7.一种产品,包括权利要求1-6之一的所述组合物,所述产品剂型为注射液、口服液、片剂、硬胶囊、软胶囊、糖果、固体饮料、液体饮料、膏滋中的一种。
8.根据权利要求7所述的产品,其特征在于,还包括辅料;其中辅料包括:水、赋形剂、色素、甜味剂、pH调节剂、增稠剂、粘合剂、崩解剂、填充剂。
9.根据权利要求7所述的产品,其特征在于,产品中的褪黑素类的成分的含量为每粒0.1mg-10mg、每片0.1mg-10mg、每瓶0.1mg-10mg、每袋0.1mg-10mg。
10.权利要求1-6之一的所述组合物、权利要求7-9之一所述产品,在助眠类药品、保健食品、膳食补充剂或食品中的应用;
或/和在肝损伤类药品、保健食品、膳食补充剂和食品中的应用;
或/和在护肝类药品、保健食品、膳食补充剂和食品中的应用;
或/和在心脏保护类的药品、保健食品、膳食补充剂和食品中的应用;
或/和在抗抑郁和抗焦虑的药品、保健食品、膳食补充剂和食品中的应用。
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