CN107233442B - 一种具有改善痛风不适症状的组合物及指纹图谱建立方法 - Google Patents
一种具有改善痛风不适症状的组合物及指纹图谱建立方法 Download PDFInfo
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Abstract
本发明涉及一种具有改善痛风不适症状的组合物及指纹图谱建立方法。所述组合物包括以重量份计的以下组分:葡萄籽萃取物50‑300份,葡萄皮萃取物50‑100份,红酒萃取物50‑200份,人参萃取物10‑50份,枸杞萃取物50‑200份,樱桃萃取物10‑100份,绿茶萃取物50‑200份。本发明各种成分合理组方、配合共用,组合物能够有效达到改善痛风引起不适症状的效果。本发明还建立了产品的指纹识别标记,建立了产品的特有及特征性,有利于产品的标准化生产。
Description
技术领域
本发明属于功能食品、保健食品技术领域,具体涉及一种具有改善痛风不适症状的组合物及指纹图谱建立方法。
背景技术
高尿酸,是继高血压、高血脂、高血糖这传统三高之后出现的第四高,而且有赶超前“三高”之势,严重威胁着人类的健康,目前国内高尿酸血症患者的发病率为10%,即约有1.3亿的潜在人群,约有1/10-1/5的高尿酸人群会发展成为痛风,痛风已成为我国第二大代谢类疾病,中华医学会发出红色预警,痛风发病率每年以7.5%的速度大幅度上升,我国痛风发病人数已达1350万人,1/5的痛风病人已丧失生活能力,痛风病人病程超过10年,绝大部分均发生难以治愈的尿毒症,从而引起了人们对这一治疗市场的广为关注。
目前,针对痛风,还是以西药治疗为主,秋水仙碱、苯溴马隆、别嘌醇是三种比较有代表性的治疗痛风药物,在有效缓解痛风症状的同时,其药物的副作用也是不容忽视的问题。秋水仙碱是人类最早用于痛风治疗的药物之一,但过量秋水仙碱有剧毒,中毒症状与砷中毒类似,即便在安全使用量范围内,秋水仙碱亦有较大副作用,主要体现在胃肠道反应,肌肉、周围神经病变,骨髓抑制,休克,致畸等,特别是骨髓增生低下及肝肾功能不全者禁用。苯溴马隆的副作用主要体现在胃肠道不适,个别情况下还会出现眼结膜发炎,短时间阳痿,头疼和尿意频增感。别嘌醇是一种抑制尿酸合成的药物,应在医生的指导下进行服用,否则过量或是长期服药,很容产生一些副作用,主要表现在消化系统反应,丘疹、荨麻疹,猝死,白细胞减少等。
针对该技术问题,已有一些相关研究报道。专利CN201710015441.2公开了一种防治痛风的中药保健茶,其原料按重量份数配比如下:牛蒡根15-30份、亚贡叶5-9份、山楂6-12份、橘皮3-10份、黄精6-12份、墨旱莲5-9份、女贞子5-9份、紫苏叶5-9份、桂枝3-7份、白芍5-9份、缬草2-5份。该中药保健茶可有效地预防和治疗痛风,针对性强,效果明显。专利CN201611259628.9提供一种治疗痛风的中药组合物及其制备方法,涉及中药领域,它由以下原料按重量份数比例组成:牛膝根10-30份,黄芪5-25份,茯苓3-20份,白术5-15份,五加皮10-30份,防己10-20份,黄荆根8-20份,木通3-12份,葛根10-25份,地骨皮5-15份,人参8-20份,枸杞10-25份;其制备方法如下:将黄芪、白术和葛根用麸皮炒过之后和剩余原料一起加水煎煮,过滤,浓缩,加入载体制得药剂学上任意一种药剂;该发明制备的中药能够有效降低血尿酸水平,总有效率达到97.55%,而且副作用小。专利CN201610997596.6公开一种用于治疗痛风的复合药物制剂及其制备方法,其配料包括,中药原料:乌稍蛇、多裂委陵菜、叉枝鸦葱、川乌、擘蓝、鸡血腾、细辛、青风藤、老鹳草、羌活、穞豆、水蛭、红门兰、威灵仙、大金发藓、珠子参、枇杷芋、透骨草、红毛草、鹅不食草、百瑞草、星色草、披麻草、油头草、篦梳剑、左黑果、萆薢、岩椒草、黄芪、薯蓣、稻蘖、丁香、桂皮、草豆蔻、茶豆、桴蓟、干姜、香附、银耳、山茴香;西药成分:醋酸泼尼松、硫酸软骨素、硫酸软骨素,马来酸氯苯那敏、右旋糖酐、腐殖酸钠、二十二碳六烯酸、酪蛋白磷酸肽、山梨糖醇。专利CN103393783B公开了一种含有白藜芦醇的组合物及用途,该组合物按重量包括下述组分:白藜芦醇100-300份;红景天提取物80-200份;红枣提取物80-250份;通过试验验证,该含有白藜芦醇的组合物具有较强的抗疲劳、增强抵抗力、抗菌消炎、祛风止痛的作用。对于痛风的患者,能够快速解除酸痛、关节屈伸不利等症状,且成本低、疗程短、见效快、无毒副作用、愈后疗效长期稳定。
上述配方的药品或者保健产品,据研究结果显示,都有改善痛风症状的效果,但上述产品中都含有中药成分,长期服用存在安全隐患。本发明在现有技术基础上继续进行了深入的研究,并对配方进行了升级和优化,做出了产品标准化指纹图谱,使得产品可以按标准生产,并在生产过程中进行严格的质量控制。
发明内容
本发明的目的是针对现有配方组合物存在的问题,提供一种全新配方的组合物,配方中所有原料均为食品级或药食同源原料,长期服用不会产生依赖性或者安全问题,并提供标准的指纹图谱作为产品特征识别。
实现本发明上述目的的技术方案为:
一种具有改善痛风不适症状的组合物,包括以重量份计的以下组分:
葡萄籽萃取物50-300份,葡萄皮萃取物50-100份,红酒萃取物50-200份,人参萃取物10-50份,枸杞萃取物50-200份,樱桃萃取物10-100份,绿茶萃取物50-200份。
优选地,所述具有改善痛风不适症状的组合物,包括以重量份计的以下组分:
葡萄籽萃取物100-260份,葡萄皮萃取物50-80份,红酒萃取物50-150份,人参萃取物10-30份,枸杞萃取物100-200份,樱桃萃取物30-70份,绿茶萃取物100-200份。
进一步优选地,所述具有改善痛风不适症状的组合物,包括以重量份计的以下组分:
葡萄籽萃取物200份,葡萄皮萃取物60份,红酒萃取物100份,人参萃取物20份,枸杞萃取物150份,樱桃萃取物50份,绿茶萃取物150份。
本发明所述葡萄籽萃取物、葡萄皮萃取物、红酒萃取物、人参萃取物、枸杞萃取物、樱桃萃取物、绿茶萃取物均可按现有技术常规方法制备,也可市售购得。
在本发明具体实施方式中,所述葡萄籽萃取物中多酚含量为50-95%;所述葡萄皮萃取物中花色素含量为5-30%,白藜芦醇含量为5-20%,多糖含量为5-10%;所述红酒萃萃取物中原花青素含量为10-50%,白藜芦醇含量为2-20%;所述人参萃取物中皂甙含量为20-80%,多糖含量为10-20%;所述枸杞萃取物中多酚含量为5-20%,多糖含量为10-50%;所述樱桃萃取物中维生素C含量为2-30%;所述绿茶萃取物中多酚含量为10-80%。
本发明还提供一种具有改善痛风不适症状的制剂,所述制剂由上述组合物单独制成,或由上述组合物和药学上或食品领域或保健食品领域可接受的载体组成。
所述制剂可为药学上各种常用剂型,例如颗粒剂、粉剂、胶囊剂、片剂汤剂、散剂或口服液等。
所述药学上可接受的载体是指药学领域常规的药物载体,选自填充剂、粘合剂、崩解剂、润滑剂、助悬剂、润湿剂、色素、香精、溶剂、表面活性剂或矫味剂中的一种或几种。
所述填充剂选自淀粉、蔗糖、乳糖、甘露醇、山梨醇、木糖醇、微晶纤维素或葡萄糖等;
所述粘合剂选自纤维素衍生物、藻酸盐、淀粉、水、糊精、明胶或聚乙烯吡咯烷酮等;
所述崩解剂选自微晶纤维素、羧甲基淀粉钠、交联聚乙烯吡咯烷酮、低取代羟丙基纤维素或交联羧甲基纤维素钠;
所述润滑剂选自硬脂酸、聚乙二醇、碳酸钙、碳酸氢钠、微粉硅胶、滑石粉或硬脂酸镁;
所述助悬剂选自微粉硅胶、蜂蜡、黄蜡、纤维素、固态聚乙二醇;
所述润湿剂选自甘油、吐温-80、凡士林、乙氧基氢化蓖麻油或卵磷脂;
所述溶剂选自陈醋、黄醋、黄酒、乙醇、液态聚乙二醇、异丙醇、吐温-80、甘油、丙二醇、植物油等中的一种或几种,所述植物油选自大豆油、蓖麻油、花生油、调和油等中的一种或几种;优选为大豆油。
所述表面活性剂选自十二烷基苯磺酸钠、硬脂酸、聚氧乙烯-聚氧丙烯共聚物、脂肪酸山梨坦或聚山梨酯(吐温)等;
所述矫味剂选自甜叶菊提取物、罗汉果提取物、香精、甘草提取物、酒石酸、柠檬酸或苹果酸。
本发明的一种优选技术方案为:所述制剂为颗粒剂,制备方法包括如下步骤:
1)按照配比称取各原料的60-100目筛下细粉,混合均匀;
2)加入粘合剂,制成20-40目的颗粒,在温度为30-70℃的条件下进行干燥,(干燥时间20-100分钟),分装,即得。
所述粘结剂的用量为其余各组分质量之和的2%-5%。
其中,所述粘结剂为水、或体积浓度为10-95%的酒精。
本发明包括上述的组合物或制剂在制备具有改善痛风不适症状的食品或保健食品或药品中的应用。
为更好地监控质量,本发明还提供上述组合物或制剂的指纹图谱的建立方法,包括UHPLC检测,条件如下:
流动相A:0.05-0.2%甲酸水溶液;优选地,流动相A:0.1%甲酸水溶液;
流动相B:乙腈
梯度洗脱:
时间/分钟 | A% | B% |
0 | 98 | 2 |
0.5 | 98 | 2 |
8 | 0 | 100 |
9 | 0 | 100 |
优选地,色谱柱:BEHC18,2.1×100mm,1.7μm;
优选地,流速:0.2-0.8mL/min;进一步优选地,流速:0.4mL/min;
优选地,柱温:20-60℃;
可采用仪器:Waters ACQUITY UPLC H-Class。
本发明的有益效果在于:
1、本发明以葡萄籽萃取物,葡萄皮萃取物,红酒萃取物,人参萃取物,枸杞萃取物,樱桃萃取物,绿茶萃取物,使各种成分合理组方、配合共用,组合物能够有效达到改善痛风引起不适症状的效果。
2、本发明提供的制剂冲调后,颜色协调,口感柔和,并有植物提取物特有的香气。
3、经过动物实验和人群测试,该组合物能有效的改善痛风引起的各种不适症状的效果。
4、建立了产品的指纹识别标记,建立了产品的特有及特征性,有利于产品的标准化生产。
附图说明
图1为实施例1制备的颗粒剂的指纹图谱。
具体实施方式
以下实施例用于说明本发明,但不用来限制本发明的范围。实施例中未注明具体技术或条件者,按照本领域内的文献所描述的技术或条件,或者按照产品说明书进行。所用试剂或仪器未注明生产厂商者,均为可通过正规渠道商购买得到的常规产品。
所述葡萄籽萃取物,其多酚含量为50-95%,购自天津益倍元天然产物技术有限公司;
所述葡萄皮萃取物,其中花色素含量为5-30%,白藜芦醇含量为5-20%,多糖含量为5-10%,购自天津益倍元天然产物技术有限公司;
所述红酒萃萃取物,其中原花青素含量为10-50%,白藜芦醇含量为2-20%购自天津益倍元天然产物技术有限公司;
所述人参萃取物,其中皂甙含量为20-80%,多糖含量为10-20%,购自天津益倍元天然产物技术有限公司;
所述枸杞萃取物,其中多酚含量为5-20%,多糖含量为10-50%,购自天津益倍元天然产物技术有限公司;
所述樱桃萃取物,其中VC含量为2-30%,购自天津益倍元天然产物技术有限公司;
所述绿茶萃取物,其多酚含量为10-80%,购自天津益倍元天然产物技术有限公司。
实施例1
具有改善痛风不适症状的组合物,配方:葡萄籽萃取物20kg,葡萄皮萃取物6kg,红酒萃取物10kg,人参萃取物2kg,枸杞萃取物15kg,樱桃萃取物5kg,绿茶萃取物15kg。
将上述组合物制成颗粒剂,制备方法如下:
1)按照配比称上述原料的80目筛下细粉,混合均匀;
2)将混合好的细粉加入粘合剂,粘合剂为质量浓度75%的酒精,粘结剂的用量为其余各组分质量之和的5%。制成40目的颗粒,在温度为60℃的条件下进行干燥,干燥时间60分钟,分装,即得。
对比例1
一种组合物,与实施例1的区别仅在于不包括樱桃萃取物和绿茶萃取物。
按与实施例1相同的方法制成颗粒剂。
实验例1
选定特定人群对组合物的功效进行了验证。
实验样品:实施例1及对比例1制备的颗粒剂。
志愿人群:100名痛风患者,随机分成两组,分别服用实施例1及对比例1制备的颗粒剂。
测试方法:两组受试人群分别服用两种组合物,每日两次,每次1.5g,服用时间为1个月,观察受试人群的痛风常见的症状的改善情况。结果见下表1和表2。
表1实施例1痛风症状改善情况调查表(n=50)
症状 | 实施例1 | 改善率 |
尿酸指标下降 | 45 | 90% |
关节疼痛减轻 | 48 | 96% |
表2对比例1痛风症状改善情况调查表(n=50)
症状 | 对比例1 | 改善率 |
尿酸指标下降 | 40 | 80% |
关节疼痛减轻 | 42 | 84% |
综合上述实验结果可知,两种组合物对于降低尿酸和缓解关节疼痛情况均有所改善,但实施例1的效果更好,差异达到显著水平(P<0.05),证明优化后的配方在改善痛风不适症状方面效果更明显。
实验例2
对实施例1制备的颗粒剂进行UHPLC检测,构建指纹图谱,条件如下:
仪器:Waters ACQUITY UPLC H-Class;
色谱柱:BEH C18,2.1×100mm,1.7μm;
流速:0.4mL/min;柱温:20-60℃;
流动相A:0.1%甲酸水溶液;
流动相B:乙腈
梯度洗脱:
时间/分钟 | A% | B% |
0 | 98 | 2 |
0.5 | 98 | 2 |
8 | 0 | 100 |
9 | 0 | 100 |
所构建的指纹图谱见图1。
虽然,上文中已经用一般性说明及具体实施方案对本发明作了详尽的描述,但在本发明基础上,可以对之作一些修改或改进,这对本领域技术人员而言是显而易见的。因此,在不偏离本发明精神的基础上所做的这些修改或改进,均属于本发明要求保护的范围。
Claims (9)
1.一种具有改善痛风不适症状的组合物,其特征在于,由以重量份计的以下组分组成:葡萄籽萃取物50-300份,葡萄皮萃取物50-100份,红酒萃取物50-200份,人参萃取物10-50份,枸杞萃取物50-200份,樱桃萃取物10-100份,绿茶萃取物50-200份;其中,
所述葡萄籽萃取物中多酚含量为50-95%;
所述葡萄皮萃取物中花色素含量为5-30%,白藜芦醇含量为5-20%,多糖含量为5-10%;
所述红酒萃取物中原花青素含量为10-50%,白藜芦醇含量为2-20%;
所述人参萃取物中皂甙含量为20-80%,多糖含量为10-20%;
所述枸杞萃取物中多酚含量为5-20%,多糖含量为10-50%;
所述樱桃萃取物中维生素C含量为2-30%;
所述绿茶萃取物中多酚含量为10-80%。
2.根据权利要求1所述的组合物,其特征在于,由以重量份计的以下组分组成:葡萄籽萃取物100-260份,葡萄皮萃取物50-80份,红酒萃取物50-150份,人参萃取物10-30份,枸杞萃取物100-200份,樱桃萃取物30-70份,绿茶萃取物100-200份。
3.根据权利要求1所述的组合物,其特征在于,由以重量份计的以下组分组成:葡萄籽萃取物200份,葡萄皮萃取物60份,红酒萃取物100份,人参萃取物20份,枸杞萃取物150份,樱桃萃取物50份,绿茶萃取物150份。
4.一种具有改善痛风不适症状的制剂,其特征在于,所述制剂由权利要求1-3任一项所述组合物单独制成,或由权利要求1-3任一项所述组合物和药学上或食品领域或保健食品领域可接受的载体组成。
5.根据权利要求4所述的制剂,其特征在于,其为颗粒剂、粉剂、胶囊剂、片剂、汤剂、散剂或口服液。
6.根据权利要求4所述的制剂,其特征在于,所述制剂为颗粒剂,制备方法包括如下步骤:
1)按照配比称取各原料的60-100目筛下细粉,混合均匀;
2)加入粘合剂,制成20-40目的颗粒,在温度为30-70℃的条件下进行干燥,分装,即得。
7.根据权利要求6所述的制剂,其特征在于,所述粘合剂的用量为其余各组分质量之和的2%-5%。
8.根据权利要求7所述的制剂,其特征在于,所述粘合剂为水、或体积浓度为10-95%的酒精。
9.权利要求1-3任一项所述组合物或权利要求4-8任一项所述制剂在制备具有改善痛风不适症状的食品或保健食品或药品中的应用。
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