CN107582663B - 一种降尿酸组合物 - Google Patents
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Abstract
本发明公开了一种降尿酸组合物,其组成物及重量为:芒果8‑22份、滇拐枣5‑14份、樱桃4‑9份、茯苓3‑8份;本发明组合物具有中和过多酸性物质,调节机体酸碱平衡,促进尿酸排泄,降低血清尿酸水平,防止因尿酸过高引起的肾脏病变、代谢疾病和心血管疾病。适用于痛风、肥胖、尿路结石、三高等不适人群;且制备工艺简单易行,适于工业化生产和市场推广应用。
Description
技术领域
本发明涉及到中药生产技术领域,特别是涉及到一种降尿酸组合物。
背景技术
痛风是一种由于机体嘌呤代谢紊乱引发的尿酸过多或者是尿酸排泄减少,并在机体内蓄积沉淀所导致的一组代谢性疾病。随着人们生活水平的提高及饮食结构的变化,痛风发病率呈逐年上升的趋势。据保守估计,目前我国有高尿酸血症患者1.2亿,患者人口接近总人口数的10%,其中北上广深等重点城市医院抗痛风药销售额增长率几乎每年都保持在30%以上。
尿酸内源性产生约占80%,外源性产生约占20%。尿酸主要通过肾脏的排泄,以维持人体尿酸水平的正常。痛风患者血尿酸水平越高,其糖尿病、心衰、高血压、心梗以及肥胖的发生率也越高,与高血压、高脂血症、动脉粥样硬化、肥胖和胰岛素抵抗等疾病的发生密切相关,是当今世界尤其是中老年男性的常见病,已成为威胁人类健康的严重代谢性疾病。
中医认为痛风是风湿顽痹证,主要是外感风寒湿邪,久病邪气痹阻经络,气血津液运行受阻。多因饮食失宜,过食肥甘厚味,湿浊内蕴,日久化热所致。痛风的发病机制,主要与湿浊、痰淤、热毒有关。对于痛风的治疗目前多采用西药为主,常用的有秋水仙碱,非甾体类抗炎镇痛药,肾上腺糖皮质激素和丙磺舒等,此类西药虽然见效快,但大多治标不治本,停药后病痛很容易又复发,而且此类药物往往毒副作用比较大,除可引起胃肠道反应外,长期服用还可能导致骨髓抑制、肝细胞损害、精神抑郁、上行性麻痹、呼吸抑制等等副作用。
目前,未曾见到以芒果、滇拐枣、樱桃、茯苓为原料制备降尿酸组合物,以及复配突涩突西(借麦凶)、撕补、宽筋藤、夺匹斋、土涩、罗木丫等彝药制备降尿酸产品的报道。
发明内容
本发明提供了一种降尿酸组合物,该组合物具有中和过多酸性物质,调节机体酸碱平衡,促进尿酸排泄,降低血清尿酸水平的功效;其组成物及重量份为:芒果8-22份 、滇拐枣5-14份、樱桃4-9份、茯苓3-8份;
本发明降尿酸组合物还可以在以上配方基础上添加透骨草(突涩突西)5-12份、小红参(撕补)7-15份、宽筋藤(基脱齐)1-7份、紫丹参(夺匹斋)17-33份、红萆薢(土涩)8-19份、马蹄香(罗木丫)0.5-3份。
突涩突西(借麦凶):(Gaultheria yunnanensis (Fr.)Rehd.)汉药名透骨草,别名满山香。苦涩,温,气香。祛风除湿,活络止痛;用于治疗四肢麻木、头痛,咳嗽,阳痿。
撕补:(Rubia yunnanensis(Fr.)Diels.)汉药名小红参,别名滇紫参、小茜草;味苦,甘平,性微温。
基脱齐:(Tinospora sinensis(Lour.)Merr)汉药名宽筋藤,别名大接筋藤;微苦,性寒;具有舒经活血,祛风除湿的功效。
夺匹斋:(Salvia yunnanensis C.H.Wright.)汉药名紫丹参,别名小活血;苦,凉;具有调经活血,散瘀,镇静止痛的功效。
土涩:(Smilax mairei Levl.)汉药名红萆薢,别名花萆薢;甘、淡、平;具有祛风除湿,通淋、利水、消炎、解毒的功效。
罗木丫:(Valeriana jatamansi Jones[V.wallichii DC.])汉药名马蹄香,别名土细辛;辛,微苦,温;具有消食健胃,理气止痛,祛风解毒的功效。
上述降尿酸组合物中各组分粉碎后混匀,可以按照常规的制备方法制成片剂、胶囊剂、软胶囊、散剂、丸剂、颗粒剂等常规口服剂型。
本发明组合物还可以按常规的中药提取方法提取原料的活性组分,再加上食品及药学上可以接受的辅料,按照常规的制备方法制成合适的口服剂型。
本发明降尿酸组合物,原料的提取方法可以采用但不限于以下方法:
(1)芒果、滇拐枣、樱桃、茯苓、土涩、撕补分别采用传统的热水回流提取法,提取料液质量体积比g:mL为1:15-20,单次提取时间1-2小时,提取2-3次,提取温度60-85℃,提取结束后上清液浓缩干燥即得相应的提取物;
(2)突涩突西(借麦凶)、基脱齐、夺匹斋、罗木丫采用传统的乙醇热回流提取法,提取料液质量体积比g:mL为1:10-15,提取液乙醇浓度55-75%,单次提取时间为0.5-1.5小时,提取2-3次,提取温度45-60℃,提取结束后上清液回收乙醇并浓缩干燥即得相应的提取物;
(3)将所得提取物按比例混合,即得本发明降尿酸组合物。
本发明通过组配芒果、滇拐枣、樱桃等补益性食材,中和机体过多酸性物质,抑制嘌呤氧化酶活性,减少尿酸的产生,调节机体酸碱平衡,促进尿酸排泄,降低血清尿酸水平,缓解尿酸累计所致的三高、心衰、心梗、肥胖以及结石等症状;同时根据中医病因辩证理论,复配突涩突西(借麦凶)、撕补、基脱齐、夺匹斋、土涩、罗木丫等彝药资源,焕发机体各项生理机能,从根本上调节身体的尿酸代谢水平,其中夺匹斋活血散瘀、镇静止痛;突涩突西(借麦凶)、基脱齐和撕补舒筋活络、祛风除湿,通行十二经络,治疗风寒湿痹,半身不遂;茯苓渗湿通降;土涩通淋利水;罗木丫解毒消炎、消食健胃。诸味原料通过君臣佐使的配伍理论,共同发挥预防和治疗高尿酸血症及痛风的作用。
本发明是通过大量的安全性及临床功效性试验进行对比分析,不断优化筛选产品配方及配方比例;产品已进行多项检测分析,降尿酸效果明显,安全性高,无明显副作用,市场推广价值极高。
具体实施方式
下面通过实施例对本发明作进一步详细说明,但本发明保护范围不局限于所述内容,实施例中方法如无特殊说明均为常规方法,使用的试剂如无特殊说明均为常规市售或按常规方法配制的试剂。
实施例1:本降尿酸组合物由以下组成物制得:芒果200g、滇拐枣80g、樱桃90g、茯苓80g;各组分粉碎后混匀,按照常规的制备方法添加辅料后制成片剂;
为验证本实施例组合物的降尿酸功效,进行组合物降低高尿酸血症对比试验研究:
将雄性昆明小鼠分为对照组与高尿酸血症组[ 腹腔注射氧嗪酸钾盐法(300mg/kg
一次性腹腔注射给药) 制备高尿酸血症动物模型]、高尿酸血症组又被随机分为模型组、
别嘌呤醇(40mg/kg) 治疗组、组合物治疗组,组合物治疗组用本实施例组合物进行灌胃,每天300mg/kg,每天灌胃3次,连续灌胃7天,观察各组小鼠血尿酸水平变化,结果如表1所示;
表1:各组小鼠实验末血尿酸浓度结果
结果表明,腹腔注射氧嗪酸钾后小鼠血清尿酸水平显著升高,与正常对照组相比,有显著性差异,提示模型成功。高尿酸血症组建立后分别给予组合物和阳性对照组治疗后,血清尿酸水平明显低于模型对照组,说明组合物具有明显的降尿酸功效,效果优于别嘌呤醇组。
实施例2:本降尿酸组合物由以下组成物制得:芒果200g、滇拐枣80g、樱桃90g、茯苓80g;
本实施例降尿酸组合物的制备方法如下:
按比例称取原料,然后将芒果、滇拐枣、樱桃、茯苓分别采用热水回流提取法,提取料液质量体积比g:mL为1:18,单次提取时间1小时,提取3次,提取温度70℃,提取结束后上清液浓缩干燥喷粉即得相应的提取物,将上述提取物混合,即得降尿酸组合物;
为验证本实施例组合物的降尿酸功效,进行组合物降低高尿酸血症对比试验研究,方法同实施例1, 组合物治疗组用本实施例的组合物进行灌胃7天,每天60mg/kg;结果如表2所示;
表2 各组小鼠实验末血尿酸浓度结果
结果表明,腹腔注射氧嗪酸钾后小鼠血清尿酸水平显著升高,与正常对照组相比,有显著性差异,提示模型成功;高尿酸血症组建立后分别给予组合物和阳性对照组治疗后,血清尿酸水平明显低于模型对照组,说明组合物具有明显的降尿酸功效,甚至效果优于别嘌呤醇组。
实施例3:本降尿酸组合物由以下组成物制得:芒果100g 、滇拐枣140g、樱桃50g、茯苓40g、突涩突西100g、撕补130g、基脱齐30g、夺匹斋250g、土涩120g、罗木丫20g;
本实施例降尿酸组合物的制备方法如下:
(1)突涩突西(借麦凶)、宽筋藤、夺匹斋、罗木丫分别采用传统的乙醇热回流提取法,提取料液质量体积比g:mL为1:12,提取液乙醇浓度70%,单次提取时间为1小时,提取3次,提取温度55℃,提取结束后上清液回收乙醇并浓缩干燥喷粉即得相应的提取物;
(2)芒果、滇拐枣、樱桃、茯苓、土涩、撕补分别采用传统的热水回流提取法,提取料液质量体积比g:mL为1: 20,单次提取时间1.5小时,提取2次,提取温度80℃,提取结束后上清液浓缩干燥喷粉即得相应的提取物;
(3)将所得提取物混合,即得降尿酸组合物。
为验证本实施例组合物的降尿酸功效,进行组合物降低高尿酸血症对比试验研究,方法同实施例1, 组合物治疗组用本实施例组合物进行物灌胃7天,每天60mg/kg,观察各组小鼠血尿酸水平变化;结果如表3所示;
表3 各组小鼠实验末血尿酸浓度结果
结果表明,腹腔注射氧嗪酸钾后小鼠血清尿酸水平显著升高,与正常对照组相比,有显著性差异,提示模型成功。高尿酸血症组建立后分别给予组合物和阳性对照组治疗后,血清尿酸水平明显低于模型对照组,说明组合物具有明显的降尿酸功效,治疗效果更优于别嘌呤醇组。
实施例4:本降尿酸组合物由以下组成物制得:芒果150g 、拐枣50g、樱桃60g、茯苓50g、突涩突西60g、撕补80g、基脱齐30g、夺匹斋200g、土涩180g、罗木丫10g;
本实施例降尿酸组合物的制备方法如下:
(1)突涩突西(借麦凶)、基脱齐、夺匹斋、罗木丫分别采用传统的乙醇热回流提取法,提取料液质量体积比g:mL为1:10,提取液乙醇浓度60%,单次提取时间为0.5小时,提取3次,提取温度60℃,提取结束后上清液回收乙醇并浓缩干燥喷粉即得相应的提取物;
(2)芒果、滇拐枣、樱桃、茯苓、土涩、撕补分别采用传统的热水回流提取法,提取料液质量体积比g:mL为1:15,单次提取时间2小时,提取2次,提取温度65℃,提取结束后上清液浓缩干燥喷粉即得相应的提取物;
(3)将所得提取物混合,即得降尿酸组合物。
为验证本实施例组合物的降尿酸功效,进行组合物降低高尿酸血症对比试验研究,方法同实施例1,结果如表4所示;
表4各组小鼠实验末血尿酸浓度结果
本组合物的的初步毒性和安全性试验:
选择健康的ICR小鼠20只,雄雌各半,体重18-22 g,给药前动物禁食约12小时,组合物用0.5羧甲基纤维素钠配制成混悬液,按最大浓度0.5g/mL、最大体积40 mL/kg体重灌胃给药,于上午9对和下午4时分别灌胃一次,给药后连续观察14天,记录动物中毒和死亡情况。灌胃给药后,动物未出现明显的异常反应,14天连续观察,未见动物出现任何中毒反应,活动自如,进食饮水和大小便均正常,体重正常增长,一般情况良好;20只动物无一死亡,处死动物后尸检,各脏器未见肉眼可见的病理改变,测得要用组合物小鼠灌胃给药的最大耐受量为,40g/kg毒性远远小于别嘌呤醇(LD50=700 mg/kg)。
Claims (1)
1.一种降尿酸组合物,其特征在于,组成物及重量份为:芒果8-22份 、滇拐枣5-14份、樱桃4-9份、茯苓3-8份、透骨草5-12份、小红参7-15份、宽筋藤1-7份、紫丹参17-33份、红萆薢8-19份、马蹄香0.5-3份。
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