CN113712982B - 一种预防或治疗非酒精性脂肪肝、肥胖症的组合物及制备方法和应用 - Google Patents
一种预防或治疗非酒精性脂肪肝、肥胖症的组合物及制备方法和应用 Download PDFInfo
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Abstract
本发明属于医药保健品技术领域,公开了一种预防或治疗非酒精性脂肪肝、肥胖症的组合物及制备方法和应用,该组合物包括组分:异槲皮素和维生素C,异槲皮素和维生素C的质量比为0.1‑2:1。本发明组合物通过异槲皮素和维生素C按照特定比例进行复配,其中维生素C促进脂肪代谢,加速脂肪分解,异槲皮素可以将脂肪酸快速氧化,同时减少脂质的生成,异槲皮素和维生素C能够起到协同增效作用,对肥胖症和非酒精性脂肪肝的疗效显著。
Description
技术领域
本发明属于医药保健品技术领域,特别涉及一种预防或治疗非酒精性脂肪肝、肥胖症的组合物及制备方法和应用。
背景技术
肝脏是机体脂质代谢的中心器官,肝内脂肪主要来源于食物和外周脂肪组织,脂类物质在肝脏内蓄积超过肝脏重量的5%,或在组织学上50%以上的肝实质脂肪化时,即为脂肪肝。脂肪肝的主要形成原因有肥胖,酒精中毒,糖尿病,营养失调,药物中毒,妊娠,遗传等原因。
目前,在全球普通人群中非酒精性脂肪性肝病患病率高达20%-30%,世界范围内超过一半的人将有发生非酒精性脂肪性肝病的危险,明显超过乙型肝炎、丙型肝炎及酒精性肝病的发病率,已成为最常见的肝病。流行病学调查显示非酒精性脂肪肝在一些发达地区的成人患病率达10%-25%,且渐趋低龄化。脂肪肝可在短期内发展为不可逆的肝损伤,其纤维化的发生率高达25%,且约有10%的患者会发展为肝硬化,严重威胁人类的健康。对非酒精性脂肪肝的治疗临床上尚缺乏疗效确切的特效药。
现有相关技术公开了一种治疗脂肪肝、肥胖症的中药提取物及其制备方法。其有效成分有木犀草素、芹菜素、槲皮素、芦丁、异槲皮素、杨梅素、异鼠李素、黄芪皂苷。其评价效果是总的提取物的药效,组分非常复杂,没有对单一物质进行评价,不能明确指出是哪种物质起作用,副作用有待商榷,且提取制备工艺复杂。
发明内容
本发明旨在至少解决上述现有技术中存在的技术问题之一。为此,本发明提出一种预防或治疗非酒精性脂肪肝、肥胖症的组合物及制备方法和应用;本发明提供的组合物对肥胖症和非酒精性脂肪肝的疗效显著。
本发明的第一方面提供一种预防或治疗非酒精性脂肪肝、肥胖症的组合物,包括组分:异槲皮素和维生素C,所述异槲皮素和所述维生素C的质量比为0.1-2:1。
本发明申请人在研究中发现,异槲皮素通过促进脂肪酸的氧化、减少脂质的生成、抑制脂肪细胞的分化和促进脂肪的褐色变,从而降低肠系膜,附睾和皮下脂肪的重量,达到减肥的效果,并且可以通过促进肌肉葡萄糖的转化吸收,提高胰岛素拮抗来调节血糖水平,起到降血糖的作用。维生素C可以合成肉碱并刺激甲肾上腺素,肉碱能够促进脂肪的新陈代谢,加速脂肪和类脂的分解和燃烧,而肾上腺素能够调节心情,抑制大脑的食欲。
本发明组合物通过异槲皮素和维生素C按照特定比例进行复配,其中维生素C促进脂肪代谢,加速脂肪分解,异槲皮素可以将脂肪酸快速氧化,同时减少脂质的生成,异槲皮素和维生素C能够起到协同增效作用,对肥胖症和非酒精性脂肪肝的疗效显著。
需要说明的是,本发明也可以采用以异槲皮素为活性成分进行改性做成的物质,例如以异槲皮素为活性物质,将异槲皮素经过糖基化,包埋,成盐或乳化等形式制备成的物质,在该物质中,异槲皮素占总重的百分比含量为1-99%。
优选地,所述异槲皮素和所述维生素C的质量比为0.1-1:1。
优选地,所述异槲皮素的人用剂量为0.2-0.4g/天。
优选地,所述维生素C的人用剂量为0.2-1.5g/天。
本发明的第二方面提供所述组合物的制备方法,包括以下步骤:
将所述异槲皮素和所述维生素C混合,得到所述组合物。
本发明的第三方面提供所述组合物在制备治疗或预防非酒精性脂肪肝、肥胖症的食品、药品和/或保健品中的应用。
优选地,所述药品或保健品的剂型为片剂、胶囊剂、颗粒剂、粉剂或口服液。
根据上述应用,本发明提供了一种保健品,包括本发明所述组合物和保健品上可接受的辅料。同时还提供了一种药品,包括本发明所述组合物和药品上可接受的辅料。另外还提供了一种食品,包括本发明所述组合物和食品上可接受的辅料。
相对于现有技术,本发明的有益效果如下:
本发明所述组合物包括异槲皮素和维生素C,各组分合理配伍产生增效协同作用,能够显著降低小鼠的肝功能指标如ALP(碱性磷酸酶),ALT(谷丙转氨酶)和AST(谷草转氨酶)。本发明组合物组分简单,安全性高,无毒副作用,显效快,疗效明确。
附图说明
图1为试验例对小鼠体重变化的检测结果图。
图2为试验例对小鼠肝脏重量变化、肝重与体重的比值的检测结果图。
图3为试验例对小鼠肝功能碱性磷酸酶、谷丙转氨酶和谷草转氨酶含量的检测结果图。
具体实施方式
为了让本领域技术人员更加清楚明白本发明所述技术方案,现列举如下实施例进行说明。需要指出的是,如下实施例对本发明要求的保护范围不构成限制作用。
如下实施例中所用的组分、试剂或装置如无特殊说明,均可从常规商业途径得到,或者可以通过现有已知方法得到。
实施例1
一种预防或治疗非酒精性脂肪肝、肥胖症的组合物,包括组分:异槲皮素和维生素C;异槲皮素和维生素C的质量比为2:1。
实施例2
一种预防或治疗非酒精性脂肪肝、肥胖症的组合物,包括组分:异槲皮素和维生素C;异槲皮素和维生素C的质量比为1:1。
实施例3
一种预防或治疗非酒精性脂肪肝、肥胖症的组合物,包括组分:异槲皮素和维生素C;异槲皮素和维生素C的质量比为0.1:1。
对比例1
与实施例1的区别在于,对比例1中不含有维生素C。
对比例2
与实施例1的区别在于,对比例2中不含有异槲皮素。
对比例3
与实施例1的区别在于,对比例3中将异槲皮素替换为槲皮素。
对比例4
与实施例1的区别在于,对比例4中将维生素C替换为维生素B。
对比例5
与实施例1的区别在于,对比例5中将维生素C替换为维生素E。
对比例6
与实施例1的区别在于,对比例6中异槲皮素和维生素C的质量比为3:1。
对比例7
与实施例1的区别在于,对比例7中异槲皮素和维生素C的质量比为0.05:1。
实施例4
一种胶囊剂,其组分包括:异槲皮素99%0.2克,维生素C 0.2克,淀粉0.1克。将各组分进行混合制粒,过筛,装胶囊,做成胶囊剂。
实施例5
一种片剂,其组分包括:糖基化异槲皮素(异槲皮素的质量含量为50%)0.5克,维生素 C 0.8克,硬脂酸镁0.3克。将各组分进行混合,计算片重,压片可得。
实施例6
一种软糖,其组分包括:白砂糖20克、糖浆40克、干明胶6克、环糊精包埋异槲皮素100克(异槲皮素的质量含量为1%),维生素C 2克,柠檬酸0.7克,柠檬酸钠0.07克。按照软糖常规制作工艺制作而成。
实施例7
一种奶昔,其组分包括:白沙糖20克,新橙皮苷二氢查尔酮0.03克,抗性糊精20克,磷脂包埋异槲皮素3克(异槲皮素的质量含量为20%),维生素C 3克,脱脂奶粉40克大豆分离蛋白20克,柑橘纤维10克,羧甲基纤维素0.5克。按照常规方法,将各组分进行混合制备而成奶昔。
试验例
1.分组与喂养
雄性C57BL6小鼠(6-8周),并在23.2℃下进行12小时的光-暗循环。经过一周的适应后,小鼠随机分为12组(n=12,5只/笼),分别按照如下组进行喂养,期间小鼠被允许随意获得水和食物,小鼠以各自的饮食维持15周。
1组:正常饲料,2组:高脂肪饲料,3组:高脂肪饲料+实施例1的样品(异槲皮素、维生素C分别占高脂肪饲料0.1wt%、0.05wt%),4组:高脂肪饲料+实施例2的样品(异槲皮素、维生素C分别占高脂肪饲料0.05wt%、0.05wt%),5组:高脂肪饲料+实施例3的样品(异槲皮素、维生素C分别占高脂肪饲料0.005wt%、0.05wt%),6组:高脂肪饲料+对比例 1的样品(异槲皮素占高脂肪饲料0.1wt%),7组:高脂肪饲料+对比例2的样品(维生素C 占高脂肪饲料0.05wt%),8组:高脂肪饲料+对比例3的样品(槲皮素、维生素C分别占高脂肪饲料0.1wt%、0.05wt%),9组:高脂肪饲料+对比例4的样品(异槲皮素、维生素B分别占高脂肪饲料0.1wt%、0.05wt%),10组:高脂肪饲料+对比例5的样品(异槲皮素、维生素E分别占高脂肪饲料0.1wt%、0.05wt%),11组:高脂肪饲料+对比例6的样品(异槲皮素、维生素C分别占高脂肪饲料0.15wt%、0.05wt%),12组:高脂肪饲料+对比例7的样品(异槲皮素、维生素C分别占高脂肪饲料0.0025wt%、0.05wt%)。
其中,正常饲料为市售商品鼠粮,脂肪含量为5%,蛋白质为25%,碳水化合物为65%,粗纤维为5%。高脂肪饲料包含20%脂肪,0.2%胆固醇,24.8%蛋白质,50%碳水化合物(含35%蔗糖)和5%粗纤维。上述饲料各组分含量均为质量百分比含量。
2.观察,检测,记录
每周测量体重和食物摄入量,每日观察小鼠食欲、排便、尿液、活动等情况,每周记录小鼠体重,绘制小鼠体重变化曲线。15周后对小鼠血清进行检测。处死小鼠摘取肝脏,称重,记录肝脏的重量。
血清中的碱性磷酸酶、谷丙转氨酶、谷草转氨酶,检测方法按照试剂盒的说明书来完成。
3.试验结果
从图1可以看出,2组由于喂养高脂肪饲料,导致小鼠的体重明显增加。3-5组在高脂肪饲料的基础上,分别添加实施例1-3的组合物,与2组相比,小鼠的体重得到明显降低,说明本发明组合物具有显著的减肥效果。6-10组在高脂肪饲料的基础上,分别添加对比例1-5 的组合物,与2组相比,小鼠的体重有所降低,但是效果并不明显,说明本发明组合物将异槲皮素和维生素C复配,具有协同增效的作用,能够显著降低小鼠的体重。11-12组在高脂肪饲料的基础上,分别添加对比例6-7的组合物,与2组相比,小鼠的体重有所降低,但是效果低于3-5组,说明本发明组合物将异槲皮素和维生素C按照特定的比例复配,能够发挥最佳效用,显著降低小鼠的体重。
从图2可以看出,2组由于喂养高脂肪饲料,导致小鼠的肝脏重量以及肝脏重量和体重的比值明显增加。3-5组在高脂肪饲料的基础上,分别添加实施例1-3的组合物,与2组相比,小鼠的肝脏重量以及肝脏重量和体重的比值得到明显降低,说明本发明组合物具有显著的降低肝细胞内脂肪含量的效果。6-10组在高脂肪饲料的基础上,分别添加对比例1-5的组合物,与2组相比,小鼠的肝脏重量以及肝脏重量和体重的比值有所降低,但是效果并不明显,说明本发明组合物将异槲皮素和维生素C复配,具有协同增效的作用,能够显著降低小鼠的肝脏重量以及肝脏重量和体重的比值。11-12组在高脂肪饲料的基础上,分别添加对比例6-7的组合物,与2组相比,小鼠的肝脏重量以及肝脏重量和体重的比值有所降低,但是效果低于 3-5组,说明本发明组合物将异槲皮素和维生素C按照特定的比例复配,能够发挥最佳效用,显著降低小鼠的肝脏重量以及肝脏重量和体重的比值。
对小鼠肝功能进行检测,从图3可以看出,3-5组在高脂肪饲料的基础上,分别添加实施例1-3的组合物,与2组相比,肝功能指标ALP(碱性磷酸酶),ALT(谷丙转氨酶)和AST(谷草转氨酶),均得到显著降低,治疗效果接近于1组。而6-10组的效果并不明显,说明本发明组合物将异槲皮素和维生素C复配,具有协同增效的作用,对长期高脂饮食小鼠的肝脏具有很好的保护作用,能够起到防止肝损伤的作用。11-12组的效果也低于3-5组,说明本发明组合物将异槲皮素和维生素C按照特定的比例复配,能够发挥最佳效用,显著降低肝功能指标。
以上对本发明的较佳实施方式进行了具体说明,但本发明创造并不限于所述实施例,熟悉本领域的技术人员在不违背本发明精神的前提下还可作出种种的等同变型或替换,这些等同的变型或替换均包含在本申请权利要求所限定的范围内。
Claims (5)
1.一种组合物作为仅有的活性成分在制备治疗或预防非酒精性脂肪肝的药品中的应用,所述组合物由异槲皮素和维生素C组成,所述异槲皮素和所述维生素C的质量比为0.1-2:1。
2.根据权利要求1所述的应用,其特征在于,所述异槲皮素和所述维生素C的质量比为0.1-1:1。
3.根据权利要求1所述的应用,其特征在于,所述异槲皮素的人用剂量为 0.2-0.4g/天。
4.根据权利要求1所述的应用,其特征在于,所述维生素C的人用剂量为 0.2-1.5g/天。
5.根据权利要求1所述的应用,其特征在于,所述药品的剂型为片剂、胶囊剂、颗粒剂、粉剂或口服液。
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Denomination of invention: A composition, preparation method, and application for preventing or treating non-alcoholic fatty liver and obesity Granted publication date: 20221206 Pledgee: Guangdong Nanhai rural commercial bank Limited by Share Ltd. Sanshui branch Pledgor: GOLDEN HEALTH BIOTECHNOLOGY Co.,Ltd. Registration number: Y2024980021086 |