CN117919346A - 治疗高尿酸血症和痛风性关节炎的药食同源中药复方及其应用 - Google Patents
治疗高尿酸血症和痛风性关节炎的药食同源中药复方及其应用 Download PDFInfo
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Abstract
本发明公开了一种治疗高尿酸血症和痛风性关节炎的药食同源中药复方及其制备方法和应用;它的原料按重量份数计包括黄芪5‑15份,茯苓1‑5份,山药15‑25份,木瓜5‑15份,薏苡仁25‑35份,黄精5‑15份,甘草1‑10份,郁李仁1‑10份,百合5‑15份,枸杞子1‑10份。本发明的中药复方由药食同源的中药组成,具有良好的降尿酸和缓解痛风的效果,能减轻痛风性关节炎引起的关节肿胀,降低炎症相关细胞因子水平。可用于治疗高尿酸血症、痛风性关节炎以及无症状痛风性关节炎。
Description
技术领域
本发明涉及中药领域,具体涉及一种治疗高尿酸血症和痛风性关节炎的药食同源中药复方及其制备方法和应用。
背景技术
高尿酸血症是一种由于长期嘌呤代谢障碍,机体尿酸生成、排泄异常,引起血清尿酸水平升高的临床常见慢性疾病,也是痛风发生、发展的高风险因素。尿酸由饮食摄入(约20%)和体内分解(约80%)的嘌呤化合物经肝脏代谢产生,约2/3通过肾脏,1/3通过消化道排泄。尿酸经肾小球滤过、近端肾小管重吸收、分泌和分泌后再吸收,未吸收部分从尿液中排出。正常情况下,体内尿酸产生和排泄保持平衡,凡导致尿酸生成过多和(或)排泄减少的因素均可导致高尿酸血症。正常情况下,人体血液中尿酸的饱和浓度为420μmol/L,当血尿酸超过饱和浓度,单钠尿酸盐晶体析出可直接黏附、沉积于关节及周围软组织、肾组织和血管等部位,趋化巨噬细胞、中性粒细胞;细胞与晶体相互作用后释放致炎症因子以及基质金属蛋白酶9、水解酶等,引起关节软骨、骨质、肾脏以及血管壁等急慢性炎症损伤,严重时会导致心、脑、肾等多器官损害。痛风性关节炎是由于机体嘌呤代谢紊乱和(或)尿酸排泄障碍,导致尿酸盐沉积于筋膜关节引起的关节炎症反应,是痛风的第一临床表现。痛风性关节炎急性发作期表现为受累关节数小时内出现红、肿、热、痛和功能障碍;给患者带来巨大痛苦,严重影响患者的生活。
高尿酸血症不仅是痛风发病的关键因素,同时也是心脑血管病、肾病的高危因素。目前,治疗高尿酸血症的主要西药有别嘌醇、非布司他、苯溴马隆、枸缘酸盐制剂和秋水仙碱等,但都存在严重的副作用,如肝功能损害、皮疹、肠胃不适、恶心腹泻以及骨髓抑制等。
现今人们对疾病的观念逐渐从治疗转向预防,从单纯依靠药物转向可替换的保健食品。药食同源产品普遍效果温和,兼顾健康、营养和安全需求,不易产生副作用,长期服用下不良反应更少。产品来源日常食材,便于购买及服用。
目前,公开号为CN114848746A的中国发明专利公开一种治疗高尿酸血症和痛风性关节炎的中药复方,按重量份计组分为:黄芪5-15份,百合5-15份,车前子5-15份,甘草5-15份,金钱草10-20份,续断5-15份,威灵仙5-15份,大黄1-10份。该复方含非药食同源的药材,安全性和适用性不稳定,不适于长期服用。
目前,公开号为CN115607634B中国发明专利公开防治高尿酸血症及痛风的中药组合物,按重量份计组分为薏苡仁5-40份、黄精3-40份、桑叶3-30份、木瓜1-20份、核桃仁0-20份。该组合物虽为药食同源材料构成,但制品单一,用量范围广,针对性疗效弱。
因此,研发治疗高尿酸血症和痛风性关节炎的药食同源中药复方及其衍生产品具有重要作用和价值。
发明内容
本发明的目的在于克服现有技术的不足,提供了一种治疗高尿酸血症和痛风性关节炎的药食同源中药复方及其制备方法和应用。
为实现上述目的,本发明所设计一种治疗高尿酸血症和痛风性关节炎的药食同源中药复方,所述中药复方的原料按重量份数计包括黄芪5-15份,茯苓1-5份,山药15-25份,木瓜5-15份,薏苡仁25-35份,黄精5-15份,甘草1-10份,郁李仁1-10份,百合5-15份,枸杞子1-10份。
进一步地,所述中药复方的原料按重量份数计包括黄芪8-12份,茯苓8-12份,山药18-22份,木瓜8-12份,薏苡仁28-32份,黄精8-12份,甘草4-8份,郁李仁4-8份,百合8-12份,枸杞子4-8份。
再进一步地,所述中药复方的原料按重量份数计包括黄芪9份,茯苓9份,山药20份,木瓜10份,薏苡仁30份,黄精9份,甘草5份,郁李仁5份,百合10份,枸杞子5份。
本发明还提供了一种上述的治疗高尿酸血症和痛风性关节炎的药食同源中药复方的制备方法,包括以下步骤:
1)按上述重量份数比称取黄芪、茯苓、山药、木瓜、薏苡仁、黄精、甘草、郁李仁、百合、枸杞子,用水浸泡,大火加热至沸腾,转文火加热后倒出头煎药,再加温水加热得到二煎药;
2)混合两次得到的药液,得到中药复方。
本发明还提供了一种上述的具有治疗高尿酸血症和痛风性关节炎的中药复方在制备高尿酸血症,痛风性关节炎,无症状痛风性关节炎的中药制剂中的应用。
本发明还提供了一种中药制剂,所述中药制剂包括上述中药复方和药学上可接受的辅料。
再进一步地,所述中药制剂为复方的个性化口感改良产品,其辅料可为维生素C、山梨醇、甘露醇、木糖醇、果糖、氨基酸、葡甲胺、糊精、硬脂酸镁和蔗糖中任意一种或几种。
再进一步地,所述中药制剂为散剂、口服液、颗粒剂、片剂、胶囊剂、丸剂、糖浆剂和膏剂中任意一种。
本发明的药理药性如下:
本发明中药复方以利水消肿为主要功效,薏苡仁和山药为君药,具有利水渗湿,健脾止泻,解毒散结,宁心安神的药效;黄芪、黄精、枸杞子、茯苓和木瓜并为臣药,前两者发挥补气养阴、益卫固表,健脾润肺的作用,后者发挥健脾消食,补充营养的作用;郁李仁为佐药,具有润肠通便、利水消肿的药效;以甘草和百合为使药,发挥益气补中,祛痰,解毒的作用,所述诸药调和。
本发明的有益效果:
1.本发明的中药复方具有良好的降尿酸和缓解痛风的药效,能减轻痛风性关节炎引起的关节肿胀,降低炎症相关细胞因子水平。可用于治疗高尿酸血症、痛风性关节炎以及无症状痛风性关节炎。
2.本发明的中药复方内配伍的药材成本低且易于购买。该方配伍的均为药食同源的药材,安全性和适用性高,无明显的副作用。该方使用的疗程短,对于高尿酸血症患者服药14天可表现良好的疗效。该方制备的散剂见效快,易于吸收,制备简单。该方制备的颗粒剂易保存,而且适口性好,方便服用。
附图说明
图1为治疗高尿酸血症和痛风性关节炎的药食同源中药复方对高尿酸小鼠血清尿酸水平的影响图;
图2为治疗高尿酸血症和痛风性关节炎的药食同源中药复方对高尿酸小鼠血清尿素氮的影响图;
图3为治疗高尿酸血症和痛风性关节炎的药食同源中药复方对高尿酸小鼠血清肌酐的影响图。
具体实施方式
下面结合具体实施例对本发明作进一步的详细描述,以便本领域技术人员理解。
实施例1
治疗高尿酸血症和痛风性关节炎的药食同源中药复方1的原料药组成为:
黄芪9g,茯苓9g,山药20g,木瓜10g,薏苡仁30g,黄精9g,甘草5g,郁李仁5g,百合10g,枸杞子5g。
上述中药材均购与湖北致和堂大药房有限公司,经准确称量后用于后续实验。
上述中药复方1的制备方法,包括以下步骤:
1)称取黄芪9g,茯苓9g,山药20g,木瓜10g,薏苡仁30g,黄精9g,甘草5g,郁李仁5g,百合10g,枸杞子5g。用冷水(蒸馏水)浸泡20min,水面超过药物2-3cm(或按料液比1:6,w/v),大火加热至沸腾,转文火加热25min(从沸腾时计起)后倒出头煎药,再加温水适量加热15min得到二煎药。
2)混合两次得到的药液,即得到中药复方1。
实施例2
本实施例制备的中药复方2与实施例1基本相同,不同之处在于:
上述中药复方2的原料按重量份数计包括黄芪8份,茯苓10份,山药15份,木瓜9份,薏苡仁25份,黄精8份,甘草4份,郁李仁4份,百合5份,枸杞子6份。
实施例3
本实施例制备的中药复方3与实施例1基本相同,不同之处在于:
上述中药复方3的原料按重量份数计包括黄芪10份,茯苓9份,山药20份,木瓜10份,薏苡仁30份,黄精6份,甘草5份,郁李仁5份,百合7份,枸杞子9份。
实施例4
一种中药复方散剂,其由以下步骤制备而成:
将实施例1中得到的中药复方水煎液用冻干机冻干,然后依次过10目,100目,200目的筛子,得到复方散剂。该散剂可以直接冲水饮用。
实施例5
一种中药复方颗粒剂,其由以下步骤制备而成:
将实施例1中得到的中药复方水煎液加热浓缩至稠膏状(约5-10g),同时称取糊精、蔗糖各50g混匀作为辅料。将稠膏先慢倒入大蒸发皿的辅料中,混合制成软材(软材的软硬应适当,以“手握成团,轻压即散”为宜)。然后用18目不锈钢筛挤压制粒,压粒入方瓷盘。放入干燥箱中,40-60℃下干燥1h左右。取出称重,再用12目与60目不锈钢筛整粒。最后再称重,并计算颗粒收率。
该颗粒剂适口性好,易保存,可直接冲水服用。
根据实施例1制备的中药复方1验证效果:
1.验证中药复方1的副作用
将实施例1制备的中药复方1,按给药剂量5000mg/kg的药剂量给大鼠灌胃,给药14天后计算小鼠的半数致死剂量;结果显示将给药剂量为5000mg/kg时大鼠未见死亡,且实验组大鼠与对照组大鼠的采食量、饮水量、体重和体重增长率没有显著性差异。该方LD50大于5000mg/kg。该范围远超过了该方的常用有效剂量。表明该复方在有效浓度下无任何副作用。
2.验证中药复方1的有效性
(1)实验材料
1.1药物:中药复方1用无菌纱布过滤后浓缩成相对生药浓度2g/mL;以及生理盐水、氧嗪酸钾和羧甲基纤维素钠(CMC-Na)。
1.2动物:雄性昆明小鼠(SPF级),体重35±2g,购自华中农业大学动物中心,伦理编号为HZAUMO-2022-0034。将所有小鼠饲养在SPF动物房中,温度和湿度适宜。6只/笼,小鼠自由采食、饮水。
1.3试剂盒:生化指标检测,如黄嘌呤氧化酶(XOD)测定试剂盒购自(南京建成生物工程研究所)。BCA蛋白浓度试剂盒购自(碧云天生物技术有限公司)。所有试剂盒检测方法均根据试剂盒内提供的说明书进行操作。
(2)实验方法
小鼠分组及给药:选SPF级健康昆明小鼠30只,随机分为5组,每组6只,组别为:空白对照组、模型组、实验组。构建高尿酸血症模型,除空白对照组外,各组灌服氧嗪酸钾(200mg/kg),而空白对照组灌服等量的CMC-Na(0.5%)。1h后,各组均给予相应剂量的药物干预(空白对照组和模型组分别口服等量的CMC-Na,实验组分别服用20.76,41.52,62.28g/kg的中药复方1)。所有各组均以这种方法连续给予7天,最后一天眼球取血,颈椎脱臼处死小鼠,取样。
小鼠血清中肾三项(UA、CREA、UREA)测定:将收集的小鼠抗凝血,用5000rpm的转速离心10分钟,分离出血清。使用生化分析仪检测血清生化指标。
(3)实验结果
小鼠血清中肾三项(UA、CREA、UREA)测定结果:测定结果显示,相对于对照组,模型组小鼠的UA、CREA、UREA发生了显著性的上调,这提示我们的高尿酸小鼠模型构建成功(图1-3),经过本实施例中的中药复方治疗后,小鼠UA、CREA、UREA水平恢复正常,提示本实施例中的中药复方能修复高尿酸小鼠的肾损伤,降低血清的尿酸水平。
3.中药配方的临床试验:
病例1:李某某,男,40岁,常年尿酸超标,有轻度的痛风性关节炎,服用本复方14天后尿酸恢复到正常水平,不适症状消失。
病例2:陈某,男,38岁,痛风多年久治不愈,且伴随偶发性关节炎,对正常工作和生活有严重影响,服用本复方15天后不适症状缓解,继续服用本方一个月后血尿酸恢复正常值,症状彻底消除。
病例3:田某某,男,45岁,常年饮食不规律引起的痛风,伴随腿部关节炎,服用本复方10天后尿酸恢复到正常水平,继续服用本方一个月后腿部的关节肿痛消失,痛风痊愈,至今未发。
综上所述,本发明能作为一种治疗高尿酸血症和痛风性关节炎的药食同源中药复方使用。
其它未详细说明的部分均为现有技术。尽管上述实施例对本发明做出了详尽的描述,但它仅仅是本发明一部分实施例,而不是全部实施例,人们还可以根据本实施例在不经创造性前提下获得其他实施例,这些实施例都属于本发明保护范围。
Claims (8)
1.一种治疗高尿酸血症和痛风性关节炎的药食同源中药复方,其特征在于:所述中药复方的原料均为药食同源,按重量份数计包括黄芪5-15份,茯苓1-5份,山药15-25份,木瓜5-15份,薏苡仁25-35份,黄精5-15份,甘草1-10份,郁李仁1-10份,百合5-15份,枸杞子1-10份。
2.根据权利要求1所述治疗高尿酸血症和痛风性关节炎的药食同源中药复方,其特征在于:所述中药复方的原料按重量份数计包括黄芪8-12份,茯苓8-12份,山药18-22份,木瓜8-12份,薏苡仁28-32份,黄精8-12份,甘草4-8份,郁李仁4-8份,百合8-12份,枸杞子4-8份。
3.根据权利要求1所述治疗高尿酸血症和痛风性关节炎的药食同源中药复方,其特征在于:所述中药复方的原料按重量份数计包括黄芪9份,茯苓9份,山药20份,木瓜10份,薏苡仁30份,黄精9份,甘草5份,郁李仁5份,百合10份,枸杞子5份。
4.一种权利要求1~3任意一项所述的药食同源中药复方的制备方法,其特征在于:包括以下步骤:
1)按上述重量份数比称取黄芪、茯苓、山药、木瓜、薏苡仁、黄精、甘草、郁李仁、百合、枸杞子用水浸泡,大火加热至沸腾,转文火加热后倒出头煎药,再加温水得到二煎药;
2)混合两次得到的药液,得到中药复方。
5.一种权利要求1~3任意一项所述的中药复方在制备高尿酸血症,痛风性关节炎,无症状痛风性关节炎的中药制剂中的应用。
6.一种中药制剂,其特征在于:所述中药制剂包括权利要求1~3任意一项所述中药复方和药学上可接受的辅料。
7.根据权利要求6所述的中药制剂,其特征在于:所述进行个性化口感改良,其辅料可为维生素C、山梨醇、甘露醇、木糖醇、果糖、氨基酸、葡甲胺、糊精、硬脂酸镁和蔗糖中任意一种或几种。
8.根据权利要求6或7所述的中药制剂,其特征在于:所述中药制剂为散剂、口服液、颗粒剂、片剂、胶囊剂、丸剂、糖浆剂和膏剂中任意一种。
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