CN107158025A - 一种含有羟基酪醇的降血脂组合物及其应用 - Google Patents
一种含有羟基酪醇的降血脂组合物及其应用 Download PDFInfo
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- A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
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Abstract
本发明公开了一种含有羟基酪醇的降血脂组合物,其特征在于:该组合物是由羟基酪醇、透明质酸、精氨酸和瓜氨酸按照一定比例构成组合物。此组合物能提高血液中高密度脂蛋白胆固醇含量,降低低密度脂蛋白胆固醇含量。本发明还提供了羟基酪醇组合物在制备具有降脂、抗氧化功能的药物和保健品中的应用;在制备可辅助预防和治疗心脑血管疾病的药物和保健品的应用。
Description
技术领域
本发明属于保健品的技术领域,具体是涉及将羟基酪醇作为功能因子,与透明质酸,精氨酸和瓜氨酸配伍,用于制备一种羟基酪醇组合物及其应用。
背景技术
心脑血管疾病是中老年人群中的常见疾病,全世界每年有1500万人死于心脑血管疾病。心脑血管疾病的致病机制主要是血液中的油脂和胆固醇沉积在血管壁上,造成血管直径变小而阻塞血液通过,进而出现冠心病等心脑血管疾病。高密度脂蛋白胆固醇(HDL-C)是血管中的“清道夫”,可将血管中的胆固醇转运到肝脏分解代谢成胆酸排出体外,所以提高血液中的HDL-C含量可降低血浆和血管壁中胆固醇水平,防止粥动脉硬化的发生。
地中海地区心脑血管疾病的发病率较低的主要原因是人们大量地食用橄榄油,而羟基酪醇作为橄榄油中的主要活性成分,发挥了重要作用。羟基酪醇(英文名hydroxytyrosol),又称为3,4-二羟基苯乙醇,是一种天然的多酚类化合物,主要以橄榄苦苷的形式存在于橄榄科橄榄属的果实和树叶中。2011年8月,欧洲食品安全局(EuropeanFood Safety Authority,EFSA)批准橄榄提取的多酚类化合物羟基酪醇具有保健功效,能维持和升高血液中HDL-C的浓度,防止低密度脂蛋白(LDL)被氧化,适度降低低密度脂蛋白胆固醇(LDL-C)浓度,防止动脉内皮细胞受到过氧化损伤而引起动脉硬化,进一步预防高血压、心脏病、脑溢血等疾病发生。
一氧化氮是体内的活性因子,可维持血管张力恒定和调节血压稳定,抑制血小板粘附和聚集。血管内一氧化氮含量不足,导致血管不能维持张力的恒定,体内血压不平稳,导致高血压、心律不齐等疾病发生。因此,适量提高体内抗氧化物质和一氧化氮的含量,对预防和治疗心脑血管疾病有积极的作用。羟基酪醇能够防止氧自由基与体内的一氧化氮发生反应,可保持体内一氧化氮的活性;精氨酸是体内产生一氧化氮的唯一底物,被广泛用在保健品和药品中,可促进体内一氧化氮产生,从而达到调节心脑血管疾病的作用;瓜氨酸能使人的血管松弛,提高大脑清晰度,提高身体免疫力。另外,在本组合物中添加透明质酸,可以促进主动脉内皮细胞及毛细管细胞的增殖和移动,促进新血管的生成。
发明人经大量的市场调研,发现目前市场上的羟基酪醇及其前体橄榄苦苷的保健产品品种繁多,但大多数均采用纯度较低的羟基酪醇提取物为原料。例如市场上广泛销售的羟基酪醇冻干粉,其中,羟基酪醇的总含量在2.5%~20%,其它成分为橄榄苦苷和多种生物碱,它们的存在影响了产品的色泽及口感,使产品的质量监控困难;另外羟基酪醇的含量低,要达到较好的保健效果,需服用大量的羟基酪醇低浓度产品,消费者的服用成本高。
针对上述困难和问题,发明者采用高纯度的羟基酪醇为初始原料,并将高纯度羟基酪醇与透明质酸,精氨酸和瓜氨酸合理配伍,该组合物实现了各组分相辅相成的作用方式,在药效上实现了突破,从前期的实验数据显示,各组分搭配合理,该组合物能有效降低血脂,预防和治疗心脑血管疾病的效果显著。
发明内容
本发明的目的是将高纯度的羟基酪醇作为活性因子,制备一种具有降低血脂,对心脑血管疾病具有预防、辅助治疗和愈后保健作用的组合物。
本发明的另一目的是提供含有羟基酪醇的降血脂组合物的应用。
为了实现上述目的,本发明采用以下技术方案:一种含有羟基酪醇的降血脂组合物,主要由以下成分制成:按重量计,羟基酪醇1~10份,透明质酸3~20份,精氨酸40~160份,瓜氨酸5~30份。
所述的含有羟基酪醇的降血脂组合物,主要由以下成分制成:按重量计,羟基酪醇2~6份,透明质酸5~15份,精氨酸50~100份,瓜氨酸10~20份。
所述的含有羟基酪醇的降血脂组合物,主要由以下成分制成:按重量计,羟基酪醇4份,透明质酸8份,精氨酸75份,瓜氨酸15份。
所述的羟基酪醇的来源,包括化学合成或植物提取,纯度>90%,化学合成羟基酪醇可采用ZL201310199087.5提供的制备方法。
所述的透明质酸的来源,包括动物来源的提取的透明质酸和发酵法制备的透明质酸。
所述的精氨酸的来源,包括提取的精氨酸和发酵制备的精氨酸。
所述的瓜氨酸的来源,包括提取、发酵及合成的瓜氨酸。
所述的含有羟基酪醇的组合物还可含有辅料成分,所述辅料成分是指药品和食品领域常规的赋形剂、稳定剂、防腐剂、抗氧剂、乳化剂、矫味剂、包衣剂等。
所述的含有羟基酪醇的组合物可通过常规方法制成各种口服制剂,包括片剂、胶囊剂、口服液、颗粒剂、功能性饮料等。
所述的含有羟基酪醇的组合物的制备方法:将所述的组合物的各成分精密称量,顺序添加,混匀,粉碎;根据对产品形状要求,添加常规的制剂辅料适量,按药典等载明的各种剂型的制备方法制成成品。
本发明所述的所有原料均符合药用和食用国家标准,所有辅料是根据剂型需要的药剂学所允许的药用辅料。
所述的组合物用于制备具有降血脂或抗氧化功能的药物和保健品的应用,并用于制备可辅助预防和治疗冠心病、心绞痛、心肌梗死、脑梗死等心脑血管疾病的药物和保健品的应用。
本发明的优点在于:
(1)所述的含有羟基酪醇的组合物优选采用纯度>90%(高效液相色谱检测)的高纯度羟基酪醇,羟基酪醇的来源包括化学合成和植物提取,高纯度羟基酪醇可明显提高该组合物的降血脂功效和抗氧化功效。
(2)所述的含有羟基酪醇的组合物是羟基酪醇,透明质酸,精氨酸和瓜氨酸按照一定的比例组方制备而成。该处方作用机制是:羟基酪醇可稳定和增加血液中高浓度脂蛋白胆固醇的浓度,还可作为一种抗氧化剂,不仅可防止氧自由基与一氧化氮反应生成具有损伤性的过氧化亚硝酸盐,还可防止透明质酸在体内降解,延长透明质酸的作用时间,保证药效。精氨酸作为一氧化氮补充剂,可防治心脑血管疾病;透明质酸可预防动脉壁再狭隘,促进新血管床的生成;瓜氨酸可起到药效加强的效果,增强身体免疫力,保护心脑血管健康。
(3)所述的含有羟基酪醇的组合物综合了四种成份的功效,合理配伍,作用全面,安全有效,在药效体现上实现了重大突破。
(4)所述的含有羟基酪醇的组合物可以实现保护心脑血管系统,预防和治疗高血脂、冠心病、心肌梗塞等疾病。
具体实施方式
结合实施例和对比例对本发明作进一步的说明,应该说明的是,下述说明仅是为了解释本发明,并不对其内容进行限定。
实施例1
取透明质酸3g,精氨酸40g,瓜氨酸5g混合后粉碎机粉碎后过60目筛,取羟基酪醇1g溶于80%乙醇中作为润湿剂制得软材,制粒,干燥(50℃),过30目筛整粒制得含有羟基酪醇的降血脂组合物。
实施例2
取透明质酸5g,精氨酸50g,瓜氨酸10g混合后粉碎机粉碎后过60目筛,取羟基酪醇2g溶于80%乙醇中作为润湿剂制得软材,制粒,干燥(50℃),过30目筛整粒制得含有羟基酪醇的降血脂组合物。
实施例3
取透明质酸13g,精氨酸80g,瓜氨酸20g混合后粉碎机粉碎后过60目筛,取羟基酪醇3g溶于80%乙醇中作为润湿剂制得软材,制粒,干燥(50℃)30分钟,过30目筛整粒制得含有羟基酪醇的降血脂组合物。
实施例4
取透明质酸8g,精氨酸75g,瓜氨酸15g混合后粉碎机粉碎后过60目筛,取羟基酪醇4g溶于80%乙醇中作为润湿剂制得软材,制粒,干燥(50℃),过30目筛整粒制得含有羟基酪醇的降血脂组合物。
实施例5
取透明质酸15g,精氨酸130g,瓜氨酸25g混合后粉碎机粉碎后过60目筛,取羟基酪醇6g溶于80%乙醇中作为润湿剂制得软材,制粒,干燥(50℃),过30目筛整粒制得含有羟基酪醇的降血脂组合物。
实施例6
取透明质酸20g,精氨酸160g,瓜氨酸30g混合后粉碎机粉碎后过60目筛,取羟基酪醇10g溶于80%乙醇中作为润湿剂制得软材,制粒,干燥(50℃),过30目筛整粒制得含有羟基酪醇的降血脂组合物。
根据实施例1~6得到的含有羟基酪醇的降血脂组合物,用于制备降脂效果的药物、抗氧化的药物、提高血清SOD活力的药物和降低低密度脂蛋白含量的药物,并用于制备具有降脂效果和具有抗氧化功能的保健食品,还可用于制备具有降脂效果和具有抗氧化功能的功能性饮料。
应用例
该组合物可以加工成片剂、胶囊、口服液、颗粒剂、功能性饮料等形式。
1.含有羟基酪醇降血脂组合物片剂的制备
按照实施例1~6得到的含有羟基酪醇的降血脂组合物,加入硬脂酸镁适量,香精适量,压片制得含有羟基酪醇降血脂组合物的片剂。
2.含有羟基酪醇降血脂组合物胶囊剂的制备
按照实施例1~6得到的含有羟基酪醇的降血脂组合物,加入微晶纤维素适量,硬脂酸镁适量,装入胶囊,制得含有羟基酪醇降血脂组合物的胶囊剂。
3.含有羟基酪醇降血脂组合物功能性饮料的制备
按照实施例1~6得到的含有羟基酪醇的降血脂组合物,加入阿斯巴甜、柠檬酸、护色剂Vc及增稠剂羟甲基纤维素钠等原料,按照料水比1:3制备含有羟基酪醇降血脂组合物的功能性饮料。
实验例
药品:羟基酪醇,山东省药学科学院提供,批号:20160620;透明质酸,华熙福瑞达生物医药有限公司,批号:20160304;精氨酸,南通飞宇生物科技有限公司,批号:20160125;瓜氨酸,山东玖胜生物科技有限公司,批号:20160227。
试剂:总胆固醇(TC)检测试剂盒由上海名典生物工程有限公司提供;高密度脂蛋白胆固醇(HDL-C)Elisa Kit检测试剂盒由上海高创化学科技有限公司提供;低密度脂蛋白胆固醇(LDL-C)检测试剂盒由瑞士罗氏公司提供;SOD、MDA检测试剂盒由南京建成生物研究所提供;其它试剂均为分析纯。
仪器:Synergy NEO全功能酶标仪,美国BIO-TEK公司。7600-010型全自动生化分析仪,日本日立公司。
实验用大鼠模型参照文献(徐淑云,卞如濂,陈修.药理实验方法学[M].北京:人民卫生出版社,第三版,2005:1203-1203)对SPF级SD大鼠进行高脂饲料喂养。
试验样品:本发明实施例4的组合物。
试验动物:Wistar大鼠,体重180~200g,雄性。
高脂饲料的配制:76.5%基础饲料,3.5%胆固醇,10%猪油,10%蛋黄粉,制成颗粒。
动物模型的建立:大鼠40只,随机分成4组。(1)对照组10只,普通饲料喂养。(2)高脂组10只,高脂饲料喂养。(3)试验组20只,分为试验组Ⅰ和试验组Ⅱ,各10只,以高脂饲料添加实施例4的组合物混合饲料喂养,其中组合物按167mg/kg.bw和334mg/kg.bw剂量添加。
饲养环境:温度18~25℃,相对湿度50%~60%,所有试验动物均为单笼饲养,自由饮水,每周称取体重,试验周期4周。
方法:第28天分别称重,禁食16h后,取尾血,分析检测。
统计学分析:数据用均值±标准差表示,以单因素方差分析法进行统计学检验。P<0.05为显著差异。
试验结果:
1.本发明组合物对大鼠体重的影响
表1大鼠体重变化
注:与对照组比较,#P<0.05,##P<0.01;与高脂饲料组比较,*P<0.05,**P<0.01。
由表1可见,在实验的4周期间,对照组大鼠体重随实验时间延长逐步增加。高脂饲料喂养各组大鼠体质量也有增加,但增加幅度明显低于对照组,试验组I和试验组II第二周至第四周其体质量明显低于空白对照组并有显著性差异,与对照组比较,受试物各组大鼠体重均无显著差异。说明该发明组合物不会额外增加实验大鼠的体重,使大鼠处于一个相对的健康的状态。
2.血脂浓度的变化
表2血脂浓度变化
注:与对照组比较,#P<0.05,##P<0.01;与高脂饲料组比较,*P<0.05,**P<0.01。
由表2可见,高脂饲料组大鼠血清的TC,LDL-C浓度均显著高于正常饲料组(P<0.01),HDL-C浓度低于正常饲料组,但在统计学上无显著性差异(P<0.05)。试验组Ⅰ、Ⅱ大鼠的血清TC和LDL-C浓度均明显低于高脂饲料组;HDL-C的浓度明显高于高脂饲料组(P<0.05)。
结果表明,高密度脂蛋白胆固醇HDL-C高于高脂组,低密度脂蛋白胆固醇LDL-C低于高脂组,且有明显差异(P<0.01)。本组合物对大鼠具有调节血脂,预防心脑血管疾病的作用。
3.大鼠血清SOD活性和MDA含量
表3大鼠血清SOD活性和MDA含量
注:与对照组比较,#P<0.05,##P<0.01;与高脂饲料组比较,*P<0.05,**P<0.01。
采用比色法对各组大鼠血清总SOD活性和MDA含量检测。与高脂饲料组对比,试验组I和试验组II的血清SOD活性明显增加(#P<0.01,##P<0.01)。与高脂饲料组对比,试验组I和试验组II的血清MDA含量明显下降,接近对照组(*P<0.01,**P<0.01)。由此可见,本发明的组合物可明显提高血清SOD活力,并降低血清MDA含量,可减少自由基损伤,具有抗氧化作用。
综上所述,本发明实施例的羟基酪醇组合物具有一定的降脂功能和抗氧化作用。
以上所描述的实施例是本发明一部分实施例,而不是全部的实施例。本发明的实施例的详细描述并非旨在限制要求保护的本发明的范围,而是仅仅表示本发明的选定实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
Claims (7)
1.一种含有羟基酪醇的降血脂组合物,其特征是,主要由以下成分制成:按重量计,羟基酪醇1~10份,透明质酸3~20份,精氨酸40~160份,瓜氨酸5~30份。
2.如权利要求1所述的含有羟基酪醇的降血脂组合物,其特征是,主要由以下成分制成:按重量计,羟基酪醇2~6份,透明质酸5~15份,精氨酸50~100份,瓜氨酸10~20份。
3.如权利要求1所述的含有羟基酪醇的降血脂组合物,其特征是,主要由以下成分制成:按重量计,羟基酪醇4份,透明质酸8份,精氨酸75份,瓜氨酸15份。
4.如权利要求1~3任一所述的含有羟基酪醇的降血脂组合物,其特征是,所述的组合物,还可含有辅料成分,所述辅料成分是指药品和食品领域常规的赋形剂、稳定剂、防腐剂、抗氧剂、乳化剂、矫味剂、包衣剂等。
5.如权利要求1~3任一所述的含有羟基酪醇的降血脂组合物,其特征是,所述的组合物可通过常规方法制成各种口服制剂,包括片剂、胶囊剂、口服液、颗粒剂、功能性饮料。
6.如权利要求1~3任一所述的含有羟基酪醇的降血脂组合物,其特征是,所述的组合物,用于制备具有降血脂或抗氧化功能的药物和保健品的应用。
7.如权利要求1~3任一所述的含有羟基酪醇的降血脂组合物,其特征是,所述的组合物,用于制备可辅助预防和治疗心脑血管疾病的药物和保健品的应用。
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CN112198269A (zh) * | 2020-04-22 | 2021-01-08 | 山东省药学科学院 | 一种测定Beagle犬血浆中羟基酪醇的方法 |
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CN114177185A (zh) * | 2021-11-29 | 2022-03-15 | 陕西海斯夫生物工程有限公司 | 一种用于降低胆固醇与预防心血管疾病的药物组合物 |
CN114177185B (zh) * | 2021-11-29 | 2022-06-17 | 陕西海斯夫生物工程有限公司 | 一种用于降低胆固醇与预防心血管疾病的药物组合物 |
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