CN114767806A - 降低尿酸的中药组合物、以其为原料的颗粒剂及它们的制备方法 - Google Patents
降低尿酸的中药组合物、以其为原料的颗粒剂及它们的制备方法 Download PDFInfo
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- CN114767806A CN114767806A CN202210197952.1A CN202210197952A CN114767806A CN 114767806 A CN114767806 A CN 114767806A CN 202210197952 A CN202210197952 A CN 202210197952A CN 114767806 A CN114767806 A CN 114767806A
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Abstract
本申请提供一种降低尿酸的中药组合物，以重量比计，所述中药组合物包括：栀子2～80份、葛根1～70份、菊苣1～60份、茯苓1～60份、薏苡仁1～50份、玉米须1～50份、金银花1～40份、高良姜1～40份。同时还提供了含有所述中药组合物的颗粒剂的流化床制粒方法。本申请的中药组合物对尿酸具有显著的降低作用，且采用的原料都是药食兼用的植物品种，无毒副作用，来源广泛易得，即使长期服药也不会对人体产生不良影响。本申请制备方法简单，易于操作，适合大规模工业化生产。
Description
技术领域
本申请降低尿酸的中药组合物、以其为原料的颗粒剂及它们的制备方法。
背景技术
高尿酸血症(HUA)是指在正常嘌呤饮食状态下，非同日两次空腹血尿酸水平男性高于420μmol/L，女性高于360μmol/L，即称为高尿酸血症。高尿酸血症临床表现为产生尿酸过多或尿酸排泄减少，血尿酸浓度持续增高，尿酸盐在关节内沉积增多，尿酸结晶，关节液中白细胞内有尿酸结晶，关节肿痛，痛风结节。在中医学中，高尿酸血症属于中医学“血浊”、“痹证”、“历节病”等范畴。高尿酸血症患病率受到多种因素的影响，与遗传、性别、年龄、生活方式、饮食习惯、药物治疗和经济发展程度等因素均有关系。据统计，目前我国大约有1.2亿高尿酸血症患者，约占全国总人口的10％，而且高尿酸血症极易引发关节变形、尿毒症、冠心病、高血压、诱发或加重糖尿病等疾病。目前临床上治疗高尿酸血症的药物主要有别嘌醇、苯溴马隆、拉布立酶等。但由于这些药物可能导致胃肠不适、过敏反应、肾毒性以及肝毒性等副作用，其临床应用受到不同程度的限制。中药煎剂如加味四妙汤、桂枝附子汤治疗高尿酸血症及痛风已有较长的历史。但是，中医治疗痛风的中药中，毒、麻和限制用量的品种较多，药食兼用的品种较少，长期服药对健康无益。
可见，需要有安全有效的药品或保健品。
发明内容
鉴于上述背景技术的缺点，本申请旨在提供具有降低尿酸作用的中药组合物及其制备工艺，以及其应用。
本发明具体技术方案如下：
一种中药组合物，该中药组合物是由以下重量份的原料制备而成：栀子2～80份、葛根1～70份、菊苣1～60份、茯苓1～60份、薏苡仁1～50份、玉米须1～50份、金银花1～40份、高良姜1～40份。
优选的，所述的中药组合物是由以下重量份的原料制备而成：栀子2～60份、葛根1～50份、菊苣1～40份、茯苓1～40份、薏苡仁1～30份、玉米须1～30份、金银花1～25份、高良姜1～25份。
进一步优选的，所述的中药组合物是由以下重量份的原料制备而成：栀子10～40份、葛根10～40份、菊苣10～30份、茯苓10～30份、薏苡仁5～20份、玉米须5～20份、金银花5～15份、高良姜5～15份。
具体的，本发明所述的中药组合物由以下重量份的原料制备而成：栀子70份、葛根60份、菊苣50份、茯苓50份、薏苡仁40份、玉米须40份、金银花30份、高良姜30份；
或栀子50份、葛根45份、菊苣35份、茯苓35份、薏苡仁25份、玉米须25份、金银花20份、高良姜20份；
或栀子35份、葛根35份、菊苣25份、茯苓25份、薏苡仁15份、玉米须15份、金银花10份、高良姜10份。
本发明的另一目的在于提供所述的中药组合物的制备方法，步骤如下：分别称取栀子、葛根、菊苣、茯苓、薏苡仁、玉米须、金银花、高良姜；加入药材总重量5～30倍的纯化水，加热回流提取1～4次，每次提取0.5～4.0h，过滤，合并提取液，提取液浓缩制成比重为1.00～1.35的浓缩液。
本发明所述的中药组合物在制备用于降低尿酸的药物或保健食品中的应用。
所述的保健食品、药物为片剂或胶囊剂或颗粒剂。
一种含有本发明所述的中药组合物的颗粒剂，所述的颗粒剂是由以下重量份的原料制备而成：栀子2～80份、葛根1～70份、菊苣1～60份、茯苓1～60份、薏苡仁1～50份、玉米须1～50份、金银花1～40份、高良姜1～40份，填充剂5～50份，甜味剂1～10份，酸味剂1～5份，润滑剂1～5份。
优选的，所述的含有中药组合物的颗粒剂是由以下重量份的原料制备而成：栀子2～60份、葛根1～50份、菊苣1～40份、茯苓1～40份、薏苡仁1～30份、玉米须1～30份、金银花1～25份、高良姜1～25份，填充剂10～40份，甜味剂1～8份，酸味剂1～4份，润滑剂1～4份。
进一步优选的，所述的含有中药组合物的颗粒剂是由以下重量份的原料制备而成：栀子10～40份、葛根10～40份、菊苣10～30份、茯苓10～30份、薏苡仁5～20份、玉米须5～20份、金银花5～15份、高良姜5～15份，填充剂10～35份，甜味剂1～6份，酸味剂1～3份，润滑剂1～3份。
具体的，本发明所述的中药组合物由以下重量份的原料制备而成：栀子70份、葛根60份、菊苣50份、茯苓50份、薏苡仁40份、玉米须40份、金银花30份、高良姜30份和填充剂45份、甜味剂9份、酸味剂4.5份、润滑剂4.5份；或栀子50份、葛根45份、菊苣35份、茯苓35份、薏苡仁25份、玉米须25份、金银花20份、高良姜20份和填充剂35份、甜味剂7份、酸味剂3.5份、润滑剂3.5份；或栀子35份、葛根35份、菊苣25份、茯苓25份、薏苡仁15份、玉米须15份、金银花10份、高良姜10份和填充剂30份、甜味剂5份、酸味剂2.5份、润滑剂2.5份。
所述的填充剂为麦芽糊精、糊精、玉米淀粉、改性玉米淀粉、马铃薯淀粉、预胶化淀粉、乳糖、微晶纤维素中的一种或者几种。
所述的甜味剂为甜菊糖、三氯蔗糖、赤藓糖醇、木糖醇、白砂糖中的一种或几种。
所述的酸味剂为柠檬酸、柠檬酸钠、乳酸、苹果酸中的一种或几种。
所述的润滑剂为硬脂酸镁、滑石粉、药用二氧化硅中的一种或几种。
一种含有本发明所述的中药组合物的颗粒剂的制备方法，包括以下步骤：
步骤(1)、提取、浓缩：分别称取栀子、葛根、菊苣、茯苓、薏苡仁、玉米须、金银花、高良姜；加入药材总重量5～30倍的纯化水，加热回流提取1～4次，每次提取0.5～4.0h，过滤，合并提取液，提取液浓缩制成比重为1.00～1.35的浓缩液；
步骤(2)、制粒：浓缩液和填充剂制成颗粒；
步骤(3)、混合：加入甜味剂、酸味剂、润滑剂，与上述颗粒混匀，制成颗粒。
优选的，将制成的颗粒进一步制成片剂或胶囊剂。
步骤(2)中，制成的颗粒过16～24目筛。
作为本发明的优选方案，所述的制粒采用流化床制粒。
一种含有本发明所述的中药组合物的颗粒剂的流化床制粒方法，包括下述步骤：
步骤(1)、提取、浓缩：分别称取栀子、葛根、菊苣、茯苓、薏苡仁、玉米须、金银花、高良姜；加入药材总重量5～30倍的纯化水，加热回流提取1～4次，每次提取0.5～4.0h，过滤，合并提取液，提取液浓缩制成比重为1.00～1.35的浓缩液；
步骤(2)、流化床制粒：将进风空气加热至20～80℃，使流化床内的填充剂呈流化状态；采用蠕动泵将浓缩液送入喷枪管，由压缩空气将浓缩液喷成雾状，散布在流化状态粉体表面，使粉体相互碰撞凝集成颗粒；
步骤(3)、混合：加入甜味剂、酸味剂、润滑剂，与上述颗粒混匀，制成颗粒。
步骤(2)中，所述的浓缩液的流速为0.1～5.0kg/min，避免流速过高或过低出现塌床无法干燥。
所述的压缩空气将浓缩液喷成雾状的压力为10～500KPa。
所述的压缩空气将填充剂喷成雾状的压力为70KPa。
本配方依据中医的清热化湿、健脾化浊、渗水利湿为指导原则，运用菊苣、葛根、金银花、栀子清热解毒、利湿；高良姜温胃散寒、健脾，行气,止痛；茯苓、薏苡仁、玉米须健脾渗湿，利水。菊苣具有清热解毒、利尿消肿的功效，可以用于治疗湿热黄疸、肾炎水肿，具有明显的降尿酸作用。葛根具有解肌退热，透疹，生津止渴，升阳止泻的功效，具有抗痛风性关节炎的作用，能缓解急性痛风性关节炎肿胀症状，具有明显的降尿酸作用。金银花具有清热解毒、祛邪宣散风热的功效。栀子具有护肝、利胆、降压、镇静、止血、消肿等作用，可以通过促进尿酸排泄降低血清中的尿酸水平。茯苓、薏苡仁利水渗湿，健脾宁心，泻膀胱，治肾积奔豚，加速排泄人体中的尿酸。玉米须健脾护肾、消水肿、利小便，可以调节人体酸碱平衡，可以促进血液中尿酸从尿液排泄，从而达到辅助降尿酸的作用。
本发明的有益效果：
本发明的食品可降低尿酸，采用的原料都是药食兼用的植物品种，食用安全、无毒副作用，来源广泛易得。即使长期服药也不会对人体产生不良影响，能克服现有治疗痛风的中西药的弊端。本发明制备方法简单，易于操作，适合大规模工业化生产。
具体实施方式
实施例1
取以下重量份数的原料：
栀子70份、葛根60份、菊苣50份、茯苓50份、薏苡仁40份、玉米须40份、金银花30份、高良姜30份和填充剂填充剂(麦芽糊精:微晶纤维素:糊精的重量比＝1:1:1)45份、甜味剂(甜菊糖)9份、酸味剂(柠檬酸)4.5份、润滑剂(药用二氧化硅)4.5份。按照以下制备方法制得中药组合物：
步骤(1)、提取、浓缩：取栀子、葛根、菊苣、茯苓、薏苡仁、玉米须、金银花、高良姜，加入药材总重量20倍的纯化水，加热回流提取2.5h，提取3次，过滤，得提取液；提取液浓缩制成比重为1.2的浓缩液；
步骤(2)、流化床制粒：将进风风源空气加热至70℃，热空气使床层内的填充剂呈流化状态；采用蠕动泵将浓缩液送入喷枪管的速度为0.3kg/min；由压缩空气将浓缩液喷成雾状，喷成雾状的压力为50KPa；浓缩液散布在流态粉体表面，使粉体相互碰撞凝集成颗粒；
步骤(3)、将上述颗粒与甜菊糖、柠檬酸、二氧化硅总混，得到复合颗粒。
实施例2
取以下重量份数的原料：栀子50份、葛根45份、菊苣35份、茯苓35份、薏苡仁25份、玉米须25份、金银花20份、高良姜20份和填充剂(麦芽糊精:淀粉:糊精的重量比＝1:1:1)35份、甜味剂(三氯蔗糖)7份、酸味剂(苹果酸)3.5份、润滑剂(药用二氧化硅)3.5份。按照以下制备方法制得中药组合物：
步骤(1)、提取、浓缩：取栀子、葛根、菊苣、茯苓、薏苡仁、玉米须、金银花、高良姜，加入药材总重量25倍的纯化水，加热回流提取2.0h，提取2次，过滤，得提取液；提取液浓缩制成比重为1.15的浓缩液；
步骤(2)、流化床制粒：将进风风源空气加热至30℃，热空气使床层内的填充剂呈流化状态；采用蠕动泵将浓缩液送入喷枪管的速度为0.5kg/min；由压缩空气将浓缩液喷成雾状，喷成雾状的压力为30KPa；浓缩液散布在流态粉体表面，使粉体相互碰撞凝集成颗粒；
步骤(3)、将上述颗粒与三氯蔗糖、苹果酸、二氧化硅总混，得到复合颗粒。
实施例3
取以下重量份数的原料：栀子35份、葛根35份、菊苣25份、茯苓25份、薏苡仁15份、玉米须15份、金银花10份、高良姜10份和填充剂(麦芽糊精:糊精的重量比＝1:1)30份、甜味剂(赤藓糖醇)5份、酸味剂(苹果酸)2.5份、润滑剂(药用二氧化硅)2.5份。按照以下制备方法制得中药组合物：
步骤(1)、提取、浓缩：取栀子、葛根、菊苣、茯苓、薏苡仁、玉米须、金银花、高良姜，加入药材总重量30倍的纯化水，加热回流提取3.0h，提取2次，过滤，得提取液；提取液浓缩制成比重为1.15的浓缩液；
步骤(2)、流化床制粒：将进风风源空气加热至50℃，热空气使床层内的填充剂呈流化状态；采用蠕动泵将浓缩液送入喷枪管的速度为0.8kg/min；由压缩空气将浓缩液喷成雾状，喷成雾状的压力为60KPa；浓缩液散布在流态粉体表面，使粉体相互碰撞凝集成颗粒；
步骤(3)、将上述颗粒与赤藓糖醇、苹果酸、二氧化硅总混，得到复合颗粒。
降尿酸实验
1.1实验组
分组与剂量设置：取260只昆明小鼠，适应性喂养5天后，按体重随机分为正常对照组、模型对照组、实施例1、2、3、21个拆方组(2.0g/kg体重)共21组。实施例1、2、3中，人体推荐剂量每天15.1g生药/60kg·BW，即：2.29g生药/kg·BW，以蒸馏水为溶剂将样品分别配制所需浓度0.229g生药/mL，按每天0.1mL/10g·BW连续经口灌胃30天。
各组具体信息如下：
A1组：栀子10份、葛根10份
A2组：栀子10份、茯苓10份
A3组：栀子10份、玉米须5份
A4组：栀子10份、高良姜5份
A5组：栀子10份、葛根10份、菊苣10份
A6组：栀子10份、茯苓10份、薏苡仁5份
A7组：栀子10份、玉米须5份、金银花5份
A8组：玉米须5份、金银花5份、高良姜5份
A9组：菊苣10份、茯苓10份、薏苡仁5份
A10组：栀子10份、葛根10份、菊苣10份、茯苓10份
A11组：薏苡仁5份、玉米须5份、金银花5份、高良姜5份
A12组：栀子10份、葛根10份、菊苣10份、茯苓10份、薏苡仁5份
A13组：栀子10份、葛根10份、菊苣10份、茯苓10份、玉米须5份
A14组：栀子10份、葛根10份、菊苣10份、茯苓10份、金银花5份
A15组：栀子10份、葛根10份、菊苣10份、茯苓10份、高良姜5份
A16组：茯苓10份、薏苡仁5份、玉米须5份、金银花5份、高良姜5份
A17组：栀子10份、葛根10份、菊苣10份、茯苓10份、薏苡仁5份、玉米须5份
A18组：栀子10份、葛根10份、菊苣10份、茯苓10份、薏苡仁5份、金银花5份
A19组：栀子10份、葛根10份、菊苣10份、茯苓10份、薏苡仁5份、高良姜5份
A20组：栀子10份、葛根10份、菊苣10份、茯苓10份、薏苡仁5份、玉米须5份、金银花5份
A21组：栀子10份、葛根10份、菊苣10份、茯苓10份、薏苡仁5份、玉米须5份、高良姜5份
1.2实验方法
正常组和模型组灌胃(ig)等体积0.8％CMC-Na溶液(0.02mL/g)。连续给药7天，每天1次，最后1次于造模1h后给药。采用氧嗪酸钾盐按250mg/kg剂量腹腔注射(ip)各实验组和模型组的小鼠造模，正常组则ip等体积0.8％CMC-Na溶液。各实验用药1h后从小鼠眼眶后静脉丛进行采血，在4000r/min条件下离心5min取血清100μL，采用半自动生化仪测定血清尿酸(UA)。
1.3结果
从表中可以看出，造模组与正常组相比血尿酸水平明显增高(P<0.01)。与模型组比较，实施例1、2、3对血清尿酸水平均有显著的抑制作用(P<0.01，P<0.05)，而各拆方组对小鼠的血尿酸水平抑制作用不明显，无统计学差异(p>0.05)，见表1。此结果说明本发明中药组合物对尿酸具有显著的降低作用，效果优于拆方组。
表1实施例对高尿酸血症小鼠血清尿酸水平的影响(x±s,n＝10)
| 分组 | 尿酸值(mg/L) |
| 正常组 | 29.99±9.52 |
| 模型组 | 51.46±10.09△△ |
| 实施例1 | 34.54±9.37** |
| 实施例2 | 37.89±9.22* |
| 实施例3 | 39.01±8.31* |
| A1组 | 50.08±3.75△△ |
| A2组 | 50.83±8.59△△ |
| A3组 | 51.92±10.33△△ |
| A4组 | 50.84±15.37△△ |
| A5组 | 49.45±8.65△△ |
| A6组 | 46.19±11.66△△ |
| A7组 | 46.74±14.40△△ |
| A8组 | 49.70±11.32△△ |
| A9组 | 52.81±10.83△△ |
| A10组 | 50.42±11.85△△ |
| A11组 | 54.18±18.30△△ |
| A12组 | 46.85±13.18△△ |
| A13组 | 47.13±14.70△△ |
| A14组 | 50.88±13.25△△ |
| A15组 | 48.16±14.26△△ |
| A16组 | 50.27±11.49△△ |
| A17组 | 46.37±12.40△△ |
| A18组 | 42.94±12.12△ |
| A19组 | 48.07±16.90△△ |
| A20组 | 43.59±15.60△ |
| A21组 | 48.63±15.08△△ |
注：△△P<0.01vs正常组；*P<0.05,**P<0.01vs模型组
1.4结论
本发明提供的中药组合物对尿酸具有显著的降低作用。
以上对本申请实施例进行了详细介绍，本文中应用了具体个例对本申请的原理及实施方式进行了阐述，以上实施例的说明仅用于帮助理解本申请的方法及其核心思想。同时，本领域技术人员依据本申请的思想，基于本申请的具体实施方式及应用范围上做出的改变或变形之处，都属于本申请保护的范围。综上所述，本说明书内容不应理解为对本申请的限制。
Claims (10)
1.一种降低尿酸的中药组合物，其特征在于，以重量比计，所述中药组合物包括：
栀子2～80份、葛根1～70份、菊苣1～60份、茯苓1～60份、薏苡仁1～50份、玉米须1～50份、金银花1～40份、高良姜1～40份。
2.根据权利要求1所述的中药组合物，其特征在于，所述中药组合物包括：
栀子2～60份、葛根1～50份、菊苣1～40份、茯苓1～40份、薏苡仁1～30份、玉米须1～30份、金银花1～25份、高良姜1～25份；
优选地，所述中药组合物包括：
栀子10～40份、葛根10～40份、菊苣10～30份、茯苓10～30份、薏苡仁5～20份、玉米须5～20份、金银花5～15份、高良姜5～15份。
3.权利要求1或2所述的中药组合物在制备用于降低尿酸的药物或保健食品中的应用。
4.权利要求1所述的中药组合物的制备方法，其特征在于，步骤如下：
分别称取栀子、葛根、菊苣、茯苓、薏苡仁、玉米须、金银花、高良姜；
加入药材总重量5～30倍的纯化水，加热回流提取1～4次，每次提取0.5～4.0h，过滤，合并提取液，提取液浓缩制成比重为1.00～1.35的浓缩液。
5.一种含有权利要求1所述的中药组合物的颗粒剂，其特征在于，所述的颗粒剂由以下重量份的原料制备而成：栀子2～80份、葛根1～70份、菊苣1～60份、茯苓1～60份、薏苡仁1～50份、玉米须1～50份、金银花1～40份、高良姜1～40份，填充剂5～50份，甜味剂1～10份，酸味剂1～5份，润滑剂1～5份。
6.根据权利要求5所述的颗粒剂，其特征在于，所述的颗粒剂由以下重量份的原料制备而成：栀子2～60份、葛根1～50份、菊苣1～40份、茯苓1～40份、薏苡仁1～30份、玉米须1～30份、金银花1～25份、高良姜1～25份，填充剂10～40份，甜味剂1～8份，酸味剂1～4份，润滑剂1～4份。
7.根据权利要求5或6所述的颗粒剂，其特征在于，所述的填充剂为麦芽糊精、糊精、玉米淀粉、改性玉米淀粉、马铃薯淀粉、预胶化淀粉、乳糖、微晶纤维素中的一种或者几种；
所述的甜味剂为甜菊糖、三氯蔗糖、赤藓糖醇、木糖醇、白砂糖中的一种或几种；
所述的酸味剂为柠檬酸、柠檬酸钠、乳酸、苹果酸中的一种或几种；
所述的润滑剂为硬脂酸镁、滑石粉、二氧化硅中的一种或几种。
8.一种权利要求5或6所述的颗粒剂的制备方法，其特征在于，包括以下步骤：
提取、浓缩：分别称取栀子、葛根、菊苣、茯苓、薏苡仁、玉米须、金银花、高良姜；加入药材总重量5～30倍的纯化水，加热回流提取1～4次，每次提取0.5～4.0h，过滤，合并提取液，提取液浓缩制成比重为1.00～1.35的浓缩液；
制粒：浓缩液和填充剂制成颗粒；
混合：加入甜味剂、酸味剂、润滑剂，与上述颗粒混匀，制成颗粒；
优选的，将制成的颗粒进一步制成片剂或胶囊剂。
9.根据权利要求8所述的颗粒剂的制备方法，其特征在于，所述的制粒为流化床制粒，具体为：将进风空气加热至20～80℃，使流化床内的填充剂呈流化状态；采用蠕动泵将浓缩液送入喷枪管，由压缩空气将浓缩液喷成雾状，散布在流化状态粉体表面，使粉体相互碰撞凝集成颗粒，即得。
10.根据权利要求9所述的颗粒剂的制备方法，其特征在于，所述的浓缩液的流速为0.1～5.0kg/min；压缩空气将浓缩液喷成雾状的压力为10～500kPa。
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