CN113384612A - 一种抗痛风组合物及其制备方法和应用 - Google Patents
一种抗痛风组合物及其制备方法和应用 Download PDFInfo
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- CN113384612A CN113384612A CN202110828591.1A CN202110828591A CN113384612A CN 113384612 A CN113384612 A CN 113384612A CN 202110828591 A CN202110828591 A CN 202110828591A CN 113384612 A CN113384612 A CN 113384612A
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Abstract
本发明公开了一种本发明涉及一种抗痛风组合物及其制备方法和应用，原料组分重量份数计：主药：金银花20～80份、葵花盘20～80份；辅以：高良姜1～20份、松茸1～20份、竹荪1～20份、山银花1～30份、栀子1～30份、桔梗1～30份、五加皮1～30份、铁皮石斛1～30份、藤茶1～30份、甘草1～30份、富含原花青素的水果蓝莓1～20份、杨梅1～20份、樱桃1～20份、车厘子1～20份、山楂1～20份、雪莲果1～20份、菠萝1～20份、柠檬1～20份。本发明提供的组合物配伍合理，为新型药食同源的抗痛风组合物，能够很好的降低血尿酸水平，改善相关炎症指标，缓解痛风疼痛感。长期服用安全，无副作用。本发明提供的抗痛风组合物的制备方法简单，价格低廉。本发明解决了现有用于抗痛风的药物大多为西药，存在副作用大的问题。
Description
技术领域
本发明涉及医药保健品技术领域，特别涉及为一种具有抗痛风功能的组合物及其制备方法和应用。
背景技术
痛风是一种单钠尿酸盐沉积所致关节病，与嘌呤代谢紊乱和血液中尿酸水平直接相关。随着经济的发展，人们以往的饮食习惯发生改变，不合理的饮食习惯的延续，我国痛风患病率也持续上升。当人体长期处于高尿酸血症的情况下，尿酸即以钠盐的形式沉淀在软骨、软组织、关节处聚集导致痛风。痛风患者经常会在夜晚出现突然性的关节疼，关节部位出现严重的疼痛、红肿和炎症，通常疼痛感会慢慢减轻直至消失，持续几天或几周不等。
根据痛风的发生机制，其治疗手段主要有减少尿酸生成和增加尿酸排泄。在我国用于抗痛风的药物主要为西药别嘌醇、非布司他和苯溴马隆。尿酸生成抑制剂别嘌醇和非布司他被认为是治疗普通痛风患者的一线药。别嘌醇及其代谢产物氧嘌呤醇均能抑制还原型黄嘌呤氧化酶，阻止次黄嘌呤和黄嘌呤代谢为尿酸，从而减少尿酸的生成，减少尿酸盐聚集导致痛风。但别嘌醇近年来因超敏反应综合征引发关注，尤其在亚裔人群中。《高尿酸血症和痛风治疗的中国专家共识》建议亚裔人群使用该药物治疗前需进行基因检测，以减少相关超敏反应的发生。非布司他可同时抑制氧化型和还原型黄嘌呤氧化酶，减少尿酸生成，且作用强于别嘌醇。但非布司他因其严重的心血管不良事件，获得FDA黑框警告。苯溴马隆是促进尿酸排泄的经典药物，通过抑制肾小管对尿酸重吸收而促进尿酸排泄。但其不良反应中肝损害问题比较突出，已陆续在一些国家下市。因此，目前市场上缺乏一款安全有效的痛风治疗药物。
“药食同源”指许多食物即药物，食物和药物一样能够防治疾病。近年来，既可以作为天然食品食用又能达到治病防病效果的“药食同源”中药因其毒副作用低，制备工艺简单而受到了研究者的广泛关注。“药食同源”中药经历几千年的使用验证了其安全性，在药品及保健品行业具有巨大的开发优势。“药食同源”产品的开发工艺主要包括粉碎、提取、干燥、制粒制片等，具有工艺简单，成本低廉的优点。目前我国痛风患者人数激增，且西药对于痛风的治疗存在局限，这对于抗痛风“药食同源”产品的开发是一个极佳的机会。因此，对将具有抗痛风作用的“药食同源”材料进行开发，在保证安全的情况下发挥其功效，突出“药食同源”的优势，为抗痛风产品的开发开拓更好的前景。
为此，我们提出了安全有效的一种抗痛风组合物及其制备方法。
发明内容
本发明的目的在于提供一种抗痛风功能的组合物及其制备方法和应用，以解决上述背景中提出的抗痛风药物多为西药，毒副作用大的问题。
为实现上述目的，本发明提供以下技术方案：一种抗痛风食源性组合物，包括以下按重量份数计的原料：金银花20～80份、葵花盘20～80份。
进一步的，还包括如下重量份数的成分中的一种或两种以上的混合物：高良姜1～20份、松茸1～20份、竹荪1～20份、山银花1～30份、栀子1～30份、桔梗1～30份、五加皮1～30份、铁皮石斛1～30份、藤茶1～30份、甘草1～30份、蓝莓1～20份、杨梅1～20份、樱桃1～20份、车厘子1～20份、山楂1～20份、雪莲果1～20份、菠萝1～20份、柠檬1～20份。
一种抗痛风食源性组合物的制备方法，采用以下步骤：
(1)按照比例称取原料进行清洗、烘干、杀菌处理；
(2)将原料倒入粉碎机内进行粉碎至粉末状；
(3)将中所得粉末与水按重量比1：6～12混合后加热至85～98℃提取，重复2～3次，收集提取液过滤、浓缩；
(4)将浓缩液加入低聚麦芽糖进行喷雾干燥获得抗痛风食源性组合物。
进一步的，步骤(4)中喷雾干燥的具体条件为：进风温度为150～190℃，出风温度为85℃至98℃，进样品为100mL/min至500mL/min。
一种抗痛风食源性组合物在作为痛风治疗药物中的应用。
进一步的，抗痛风食源性组合物中添加辅料，制成口服制剂。
进一步的，口服制剂为片剂、胶囊、颗粒剂、丸剂或口服液。
与现有技术相比，本发明的有益效果是：
本发明制备的抗痛风组合物能起到良好的抗痛风效果。通过主药：金银花、葵花盘；辅药：山银花、高良姜、松茸、竹荪、栀子、桔梗、五加皮、铁皮石斛、藤茶、甘草、富含原花青素的水果：蓝莓、杨梅、樱桃、车厘子、山楂、雪莲果、菠萝、柠檬等食源性材料的合理配伍，长期服用，能够很好降低血尿酸水平，改善相关炎症指标，缓解痛风疼痛感。本发明提供的抗痛风组合物的制备方法简单，价格低廉，解决了现有用于抗痛风的药物大多为西药，存在副作用大的问题。
附图说明
图1是实施例药物对热板镇痛法大鼠模型的镇痛作用对比图。
图2是实施例药物对急性痛风性关节炎模型的足趾肿胀度影响对比图。
图3是实施例药物对急性痛风性关节炎模型的相关炎症因子水平的影响对比图。
具体实施方式
为了使本技术领域的人员更好地理解本申请方案，下面将结合本申请实施例中的附图，对本申请实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本申请一部分的实施例，而不是全部的实施例。基于本申请中的实施例，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，都应当属于本申请保护的范围。
需要说明的是，本申请的说明书和权利要求书及上述附图中的术语“包括”和“具有”以及他们的任何变形，意图在于覆盖不排他的包含，例如，包含了一系列步骤或单元的过程、方法、系统、产品或设备不必限于清楚地列出的那些步骤或单元，而是可包括没有清楚地列出的或对于这些过程、方法、产品或设备固有的其它步骤或单元。
实施例1
一种抗痛风组合物及其制备方法，包括以下步骤：
按重量份数计的原料金银花20份、山银花30份、葵花盘20份、栀子20份、桔梗20份、高良姜20份、五加皮20份、蓝莓20份、杨梅10份、铁皮石斛10份、松茸10份、竹荪10份、樱桃10份、甘草10份、藤茶20份、山楂10份、雪莲果10份。倒入粉碎机内进行粉碎至粉末状，所得粉末与水按重量比1：8加热至90℃提取3h，重复3次，收集提取液过滤，浓缩。浓缩液中加入低聚麦芽糖进行喷雾干燥(进风温度为160℃，出风温度为95℃，进样品为100mL/min)，获得所述抗痛风组合物。抗痛风组合物粉末干法制粒，压片即可。
实施例2
一种抗痛风组合物及其制备方法，包括以下步骤：
按重量份数计的原料金银花60份、葵花盘40份、栀子20份、桔梗20份。倒入粉碎机内进行粉碎至粉末状，所得粉末与水按重量比1：10加热至95℃提取3h，重复3次，收集提取液过滤，浓缩。浓缩液中加入低聚麦芽糖进行喷雾干燥(进风温度为180℃，出风温度为96℃，进样品为200mL/min)，获得所述抗痛风组合物。将抗痛风组合物粉末干法制粒，灌装成胶囊即可。
实施例3
一种抗痛风组合物及其制备方法，包括以下步骤：
按重量份数计的原料金银花50份、葵花盘50份、山银花5份、栀子5份、桔梗5份、五加皮5份、铁皮石斛5份、藤茶5份、甘草5份、车厘子5份、柠檬2份。倒入粉碎机内进行粉碎至粉末状，所得粉末与水按重量比1：12加热至96℃提取3h，重复3次，收集提取液过滤，浓缩。浓缩液中加入低聚麦芽糖进行喷雾干燥(进风温度为190℃，出风温度为98℃，进样品为300mL/min)，获得所述抗痛风组合物。将抗痛风组合物粉末与辅料混合，通过制塑性团块、制丸条、分割及搓圆等工艺制备成丸剂。
对大鼠高尿酸血症模型的影响
实验动物：SPF级别雄性大鼠60只，重量200±20g。
实验分组：本发明实例1～3制得的制剂低中高剂量组，阳性对照组：别嘌醇，模型组，空白组。
造模：次黄嘌呤乳剂灌胃给药(25mg/kg)，氧嗪酸钾溶液腹腔注射(100mg/kg)。
造模后1h灌胃实验药物，3h、4h、5h、6h、8h、10h眼眶取血，HPLC分析血尿酸浓度。表1为本发明药物对高尿酸模型大鼠的降尿酸作用
表1
与正常对照组相比，#P<0.05；与模型组相比，*P<0.05。
本发明药物100mg/kg、50mg/kg、25mg/kg剂量及阳性药别嘌醇与模型组相比，可使高尿酸模型大鼠的尿酸水平显著降低。其中本发明抗痛风组合物在相同剂量或低剂量前提下，达到现有产品的降尿酸效果。
对大鼠热板法镇痛实验模型的影响
实验动物：SPF级别雄性大鼠60只，重量200±20g。
实验分组：本发明实例1～3制得的制剂组，阳性对照组：别嘌醇，空白组。
造模：预选30s内有痛反应的小鼠。将小鼠置于热板仪内，温度55±0.5℃，测定小鼠的痛阈值，测2次，每隔5min测量1次，以小鼠舔后足作为观察指标。给药后20min测定痛阈值，若小鼠60s内无痛反应，立即取出，按60s计算。
图1为本发明药物对热板镇痛法大鼠模型的镇痛作用，**P<0.01vs给药前。
对大鼠急性痛风性关节炎模型的影响
实验动物：SPF级别雄性大鼠30只，重量200±20g。
实验分组：本发明实例1～3制得的制剂组，阳性对照组：非布司他，空白组。
造模：空白组右后关节连接处注射50μL的10％的Tween-80(V/V)；其余分别注射50μL的尿酸钠溶液。造模后1h，分别口服灌胃对应的治疗药，3h对各组大鼠测量足关节的周长，记录周长，并计算大鼠足趾的肿胀度(肿胀度＝造模后增加的周长值/造模前周长×100％)。并对大鼠眼眶静脉取血，解剖取肝脏，肾脏测量相关炎症因子水平。
图2为本发明药物对急性痛风性关节炎模型的足趾肿胀度影响，**P<0.001vs模型组
图3为本发明药物对急性痛风性关节炎模型的相关炎症因子水平的影响，*P<0.05，**P<0.01，***P<0.001vs模型组
本发明提供的组合物配伍合理，为新型药食同源的中药组合物，能够很好的降低血尿酸水平，改善相关炎症指标，缓解痛风疼痛感，长期服用安全，且无副作用。本发明提供的抗痛风组合物的制备方法简单，价格低廉，解决了现有用于抗痛风的药物大多为西药，存在副作用大的问题。
以上对本发明的技术方案进行清楚、完整地描述，但本发明并不局限于上述实施方式。应当指出的是，对本领域的普通技术人员来说，在不偏离本发明的精神和范围下可以对本发明技术方案的细节和形式进行修改或替换，这些都属于本发明的保护范围。
Claims (7)
1.一种抗痛风食源性组合物，其特征在于包括以下按重量份数计的原料：金银花20～80份、葵花盘20～80份。
2.根据权利要求1所述的抗痛风食源性组合物，其特征在于：还包括如下重量份数的成分中的一种或两种以上的混合物：高良姜1～20份、松茸1～20份、竹荪1～20份、山银花1～30份、栀子1～30份、桔梗1～30份、五加皮1～30份、铁皮石斛1～30份、藤茶1～30份、甘草1～30份、蓝莓1～20份、杨梅1～20份、樱桃1～20份、车厘子1～20份、山楂1～20份、雪莲果1～20份、菠萝1～20份、柠檬1～20份。
3.一种根据权利1或2任一所述抗痛风食源性组合物的制备方法，其特征在于采用以下步骤：
(1)按照比例称取原料进行清洗、烘干、杀菌处理；
(2)将原料倒入粉碎机内进行粉碎至粉末状；
(3)将中所得粉末与水按重量比1：6～12混合后加热至85～98℃提取，重复2～3次，收集提取液过滤、浓缩；
(4)将浓缩液加入低聚麦芽糖进行喷雾干燥获得抗痛风食源性组合物。
4.根据权利要求3所述的制备方法，其特征在于：所述步骤(4)中喷雾干燥的具体条件为：进风温度为150～190℃，出风温度为85℃至98℃，进样品为100mL/min至500mL/min。
5.一种根据权利1或2任一所述抗痛风食源性组合物在作为痛风治疗药物中的应用。
6.根据权利要求5所述的应用，其特征在于：所述抗痛风食源性组合物中添加辅料，制成口服制剂。
7.根据权利要求6所述的应用，其特征在于：所述口服制剂为片剂、胶囊、颗粒剂、丸剂或口服液。
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