CN106215046A - 一种治疗急性痛风性关节炎的中药 - Google Patents
一种治疗急性痛风性关节炎的中药 Download PDFInfo
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Abstract
本发明涉及医药,特别是一种治疗急性痛风性关节炎的中药。针对西医药尚无针对性特效疗法、副作用大,效果不理想的问题。本发明提供一种治疗急性痛风性关节炎的中药,由重量计的:苍术10‑20g,黄柏5‑15g,川牛膝20‑40g,薏苡仁20‑40g,丹皮5‑15g,赤芍10‑20g,萆薢20‑40g,土茯苓20‑40g,威灵仙15‑25g,制香附10‑20g,穿山龙20‑40g,木瓜15‑25g,生山楂10‑20g,红花10‑20g,土元10‑20g,地龙10‑20g,元胡20‑30g,生甘草5‑10g制成。本发明有行瘀散结、通利水道之功效,符合中医理论又切中痛风性关节炎的病机特点,疗效确切,安全性高。
Description
技术领域
本发明涉及医药,特别是一种治疗急性痛风性关节炎的中药。
背景技术
随着我国经济的发展,饮食结构的改变,谷类构成比减少而肉类构成比增多,及老龄化社会的到来,痛风性关节炎的发病率正在逐年升高,发病年龄年轻化成该病的发病趋势,严重影响患者的生活质量和工作,必将成为危害国人健康的又一大杀手,在临床上越来越受到重视。
痛风(gout)是由于嘌呤代谢紊乱、尿酸***障碍,导致人体血尿酸水平异常增高,尿酸盐结晶在组织间沉积而形成的一种异质性疾病。以高尿酸血症,痛风石沉积,特征性急、慢性关节炎的反复发作,甚至肾功能衰竭为临床特点,严重影响患者生活质量。痛风最常见的首发症状,也是最基本的类型是急性痛风性关节炎,在下肢远端单侧关节最好发生,首发于第一跖趾关节的占发病率的半数以上;典型发作一般多在午夜因足趾疼痛而惊醒,有时呈爆发性发作,起病急骤,刀割、咬噬样疼痛为其典型症状,且伴有关节及周围组织的红、肿、热、痛。随着病程进展,逐渐侵及踝、膝、腕、指等各关节。该病男性多发病于中年,女性多发病于绝经以后,且男性高于女性,这可能与***能促进尿酸代谢有关。根据研究,尿酸对血管及代谢有一定影响,因此高尿酸血症也可引起冠心病、高血压和脑血管意外。随着科学的发展,尤其是免疫学及分子生物学的发展,炎症细胞、细胞因子及炎性体逐渐被人们认识,研究表明,它们对于痛风性关节炎的发生、发展直至自然缓解具有十分重要的意义。
在中医学中并无“痛风性关节炎”这一确切病名,但在传统中医书籍中可见到很多对于该病相似症状的描述,以及对该病病因病机以及诊疗经验的记载:《素问·痹论》:“风寒湿三气杂至,合而为痹,其风气胜者为行痹,寒气胜者为痛痹,湿气胜者为着痹也。”张仲景《金匮要略·中风历节》:“病历节,不可屈伸,疼痛,乌头汤主之”。元·朱丹溪《格致余论·痛风论》:“彼痛风者,大率因血受热已自沸腾,其后或涉冷水,或立湿地或扇风取凉,或卧当风,寒凉外抟,热血得寒,郁浊凝涩,所以作痛。”《丹溪手 镜·卷中·痛风十三》:“血久得热,感寒冒湿不得运行,所以作痛,夜则痛甚,行于阴也,亦有血虚痰逐经络上下作痛。”明·张景岳在《景岳全书·脚气》述:“外是阴寒水湿,今湿邪袭人皮肉筋脉,内由平素肥甘过度,湿热下焦,寒与湿邪相结郁而化热,停留肌肤……病变部位红肿潮热,久则骨蚀”。
中医认为,先天禀赋不足,再加上后天喜进食膏粱厚味,日久伤脾,或年老后脾肾功能失调是痛风性关节炎发病的主要原因,与劳倦、饮食、环境、外感等诱因也有一定关系。
现代医学对痛风性关节炎治疗的目的是:痛风性关节炎急性发作期要迅速加以控制;减少急性关节炎复发;降低血尿酸水平,防止尿酸盐沉积预防关节破坏及肾脏损害;严重者需要采用手术方法去除痛风石,或者通过矫形治疗毁损的关节,以提高生活质量。对本病的治疗,西医多采用秋水仙碱、降尿酸药、非甾体抗炎药,或者通过关节腔注射药物等方式。虽然有一定的疗效,但副作用大,效果不如中医药治疗效果好。中医药治疗则能整体兼顾,标本兼治,不仅能减轻症状,且能达到全身调理的目的。
发明内容
针对上述情况,为解决现有技术之缺陷,本发明之目的就是提供一种治疗急性痛风性关节炎的中药,可有效解决目前因西医药尚无针对性特效疗法、副作用大,效果不理想的问题。
本发明解决问题的技术方案是:
一种治疗急性痛风性关节炎的中药,该中药由重量计的:苍术10-20g,黄柏5-15g,川牛膝20-40g,薏苡仁20-40g,丹皮5-15g,赤芍10-20g,萆薢20-40g,土茯苓20-40g,威灵仙15-25g,制香附10-20g,穿山龙20-40g,木瓜15-25g,生山楂10-20g,红花10-20g,土元10-20g,地龙10-20g,元胡20-30g,生甘草5-10g制成。
本发明纯中药配制,具有行瘀散结、通利水道之功效,符合中医理论又切中痛风性关节炎的病机特点,药源广泛,价格低廉,疗效确切,安全性高,能整体兼顾,标本兼治,不仅能减轻症状,且能达到全身调理的目的,具有很大的优势。
具体实施方式
以下结合实施例对本发明作进一步详细说明。
实施例1
一种治疗急性痛风性关节炎的中药,该中药由重量计的:苍术15g,黄柏10g,川牛膝30g,薏苡仁30g,丹皮10g,赤芍15g,萆薢30g,土茯苓30g,威灵仙18g,制香附15g,穿山龙30g,木瓜18g,生山楂15g,红花15g,土元15g,地龙15g,元胡30g,生甘草6g制成。
实施例2
一种治疗急性痛风性关节炎的中药,该中药由重量计的:苍术10g,黄柏15g,川牛膝40g,薏苡仁40g,丹皮15g,赤芍20g,萆薢40g,土茯苓20g,威灵仙25g,制香附10g,穿山龙20g,木瓜25g,生山楂20g,红花10g,土元20g,地龙10g,元胡30g,生甘草10g制成。
实施例3
一种治疗急性痛风性关节炎的中药,该中药由重量计的:苍术20g,黄柏5g,川牛膝20g,薏苡仁20g,丹皮5g,赤芍10g,萆薢20g,土茯苓40g,威灵仙15g,制香附20g,穿山龙40g,木瓜15g,生山楂10g,红花20g,土元10g,地龙20g,元胡20g,生甘草5g制成。
中医理论认为脾肾两虚、气血不足,加之饮食不节导致病脾胃运化失司,化湿生痰,痰淤互结而发湿热内生,湿热之邪郁结,阻碍气血运行,气运失利,血脉不通,气血运行不畅,不通则痛,瘀阻经脉,湿浊内生化热而产生热毒,终致热浊相熬,痰淤互结,外邪滞留肌肉、关节、筋脉,导致经脉闭阻,毒攻关节从而发生痛风。本发明用苍术燥湿健脾,祛风散寒;薏苡仁,渗湿健脾,利水消肿,搭配黄柏清热燥湿,泻火除蒸;健脾补肾以治本,萆薢,利湿去浊,祛风除痹;土茯苓,解毒,除湿,通利关节;威灵仙,祛风湿,通络止痛;穿山龙,祛风湿,活血通络;木瓜,舒筋活络,和胃化湿;川牛膝,祛风利湿,通经活血;地龙,清热定惊、通络利尿浊排尿酸,丹皮,清热凉血,活血祛瘀;赤芍,清热凉血,散瘀止痛;红花,活血通经、祛瘀止痛;土元,破血逐瘀,续筋接骨;清热解毒、消痈散结,活血化瘀止痛类 药物,重用制香附,疏肝解郁,调经止痛;元胡活血行气止痛,生山楂,行气散瘀;施以清热利湿、利湿邪浊法,并兼活血化瘀,加用利尿中药,利小便可以除湿气,以利湿健脾、清热利尿法、予补肾健脾、祛瘀泄浊,用补肾利湿的方法降低血尿脾肾,化痰泄浊以治标,配合健脾助运化;健脾补肾以治本,配合泄浊排尿酸,两者配合以达标本兼治的目的。
在上述组分中,其中:
苍术,辛,苦,温;燥湿健脾,祛风散寒;《神农本草经》:“主风寒湿痹,死肌痉疸。作煎饵久服,轻身延年不饥。”
黄柏,苦,寒;清热燥湿,泻火除蒸,解毒疗疮;《长沙药解》:“黄柏,泄己土之湿热,清乙木之郁蒸,调热利下重,理黄疸、腹满、伤寒。”
川牛膝,甘,微苦;祛风利湿,通经活血;《四川中药志》:“祛风利湿,通经散血。治寒湿腰腿骨痛,足痿筋挛,妇女经闭及症瘕,淋病,尿血,阴痿、失溺。”
薏苡仁,甘,淡,凉;利水消肿,渗湿健脾,除痹,清热排脓;《神农本草经》:“主筋急拘挛,不可屈伸,风湿痹,下气。”
丹皮,苦,甘,微寒;清热凉血,活血祛瘀;《神农本草经》:“主寒热,中风瘈疭、痉、惊痫邪气,除坚癥瘀血留舍肠胃。”
赤芍,苦,微寒;清热凉血,散瘀止痛;白芍,苦、酸,微寒;养血敛阴,柔肝止痛;《本草求真》:“白能于土中泻木,赤则能于血中活滞。”
萆薢,苦,平;利湿去浊,祛风除痹;《神农本草经》:“主腰背痛,强骨节,风寒湿周痹。”
土茯苓,甘、淡、平;解毒,除湿,通利关节;《本草纲目》:“健脾胃,强筋骨,去风湿,利关节,止泄泻,治拘挛骨痛。”
威灵仙,辛、咸,温;祛风湿,通络止痛;《药品化义》:“灵仙,其猛急,善走而不守,宣通十二经络。主治风、湿、痰壅滞经络中,致成痛风走注,骨节疼痛,或肿,或麻木。”
制香附,辛,微苦,微甘,平;疏肝解郁,调经止痛,理气调中;《本草纲目》:“利三焦,解六郁,止心腹、肢体、头目、齿耳诸痛。”
穿山龙,苦、微寒;祛风湿,活血通络;《陕西中草药》:“治咳嗽,风湿性 关节炎,在骨节病关节痛,跌打损伤。
木瓜,酸、温;舒筋活络,和胃化湿;《本草经疏》:“木瓜温能通肌肉之滞,酸能敛濡满之湿,则脚气湿痹自除也。”
生山楂,酸,甘,微温;消食化积,行气散瘀;《本草纲目》:“化饮食,痰饮痞满吞酸,滞血胀痛。”
红花,辛、温;活血通经、祛瘀止痛;《本草汇言》:“红花,破血、行血、和血、调血之药也。”
土元,咸,寒,有小毒;破血逐瘀,续筋接骨;《本草经疏》:“治跌打扑损,续筋骨有奇效,乃厥阴经药也。”
地龙,咸、寒;清热定惊、通络、平喘、利尿;《本草纲目》:“性寒而下行,性寒故能解诸热疾,下行故能利小便,治足疾而通经络也。”
元胡,又名延胡索,辛、苦、温;活血、行气,止痛;《本草纲目》:“延胡索,能行血中气滞,故专治一身上下诸痛,用之中的,妙不可言。”
生甘草,甘、平;缓急止痛,清热止痛,调和诸药;生用性微寒,可清热解毒。《本草汇言》:“和中益气,补虚解毒之药也。”
炎性指标IL-1β、IL-8、TNF-α变化及其意义
白细胞介素类细胞因子、TNF-α等是目前痛风类药物在关节炎方面主要作用的靶点。
现代研究证实:急性痛风性关节炎主要由尿酸钠结晶引起的急性炎症反应,尿酸钠结晶沉积在关节周围,刺激局部产生大量IL-1β、IL-8、TNF-α等炎性细胞因子,从而造成局部的血管扩张、血管通透性增加、水肿、渗出、白细胞聚集。
研究表明,IL-1β、TNF-α作为前炎症网链中的一级细胞因子,不仅能够加速炎症进展,释放炎症物质如***素、白三烯和氧自由基等,而且可以促进胶原酶和其他中性蛋白酶的产生,造成软骨基质崩解、软骨吸收和骨破坏等严重后果,对于急性痛风性关节炎的发生、发展过程起到重要作用。IL-8是由IL-1β、TNF-α诱导的二级前炎症细胞因子,可趋化中性粒细胞、嗜酸(碱)性粒细胞、淋巴细胞等到炎症局部,引起炎症或***反应。基于IL-1β、IL-8、TNF-α等在痛风性关节炎的发病中所起的重要作用,在治疗 痛风性关节炎过程中,可以通过抑制这些致炎因子产生,阻断或抑制由致炎因子所介导和激发的炎症过程,对缓解病情有积极意义。
动物模型实验对本发明药效的验证
1研究内容
使用尿酸钠晶体(monosodium urate,MSU)诱导建立大鼠急性痛风性关节炎模型,在使用本发明药物治疗的过程中,观察关节滑膜中IL-1β、IL-8和TNF-α的含量变化,探讨其对痛风性关节炎的防治作用,并研究其可能的作用机制,为其在临床上的应用提供理论依据。
2研究目标
通过对发明药治疗急性痛风性关节炎模型大鼠关节滑膜中IL-1β、IL-8和TNF-α的含量变化,了解其对急性痛风性关节炎动物模型细胞因子的影响,为临床治疗本病提供可行性依据。
3实验材料
3.1实验动物
选用健康雄性SD大鼠48只,无特定病原体动物(Specific Pathogen Free,SPF),实验初始体重200±10g,由郑州大学医学院动物实验中心提供。动物统一采用独立通风笼盒(individual venti lation cages,IVC)***喂养,分16笼,每笼3只,每3天更换垫料一次,饮水进食均为自由模式,饲料为SPF级生长饲料,IVC***控制室温23±2℃,湿度17-20%,压差18kPa,换气次数25次/h,进风风速31m3/h。实验性喂养7天,每日观察记录大鼠体重及精神变化。
3.2实验药物
一种治疗急性痛风性关节炎的中药,该中药由重量计的:苍术15g,黄柏10g,川牛膝30g,薏苡仁30g,丹皮10g,赤芍15g,萆薢30g,土茯苓30g,威灵仙18g,制香附15g,穿山龙30g,木瓜18g,生山楂15g,红花15g,土元15g,地龙15g,元胡30g,生甘草6g制成。
3.3实验试剂:大鼠IL-1β、IL-8、TNF-α定量ELISA试剂盒,尿酸钠晶体,秋水仙碱片。
3.4实验仪器:低温高速离心机,组织匀浆仪,恒温水浴箱,磁力搅拌器,电子天平,冰箱,切片机等。
3.5其他材料:注射器、试管、灌胃针、烧杯、纱布、广口瓶、棉签、移液器、手术刀、弯钳、采血管等。
4实验方法
4.1动物分组 选用72只健康雄性SD大鼠,用随机分组法方法随机分为六组,将72只大鼠随机从1-72号标号,用大鼠的编号除以6,用余数分组。余数为0,1,2,3,4,5分别标为空白组、模型组、秋水仙碱组、本发明配方高剂量组、本发明配方中剂量组、本发明配方低剂量组每组12只。每组大鼠在尾部标记编号:“—”代表1,“∣”代表5,依次编号。
4.2实验药物制备
本发明配方的制备:将本发明配方称重后放入1000ml蒸馏水中浸泡1小时,水煎半小时后,过滤,将药渣再于蒸馏水中煎煮20分钟,过滤,合并两次滤液。将滤液置于60℃水浴中浓缩成含生药2g·mL-的药液,密封,放在4℃冰箱保存备用,使用时以6g·kg-1·次-1灌胃。
秋水仙碱液的制备:将秋水仙碱片研成细末,配置成0.05g·L-1的秋水仙碱混悬液,放入4℃冰箱保存备用,使用时以lmg·kg-1·次-1灌胃。
尿酸钠溶液的制备:取500mg尿酸钠晶体加18ml生理盐水,加热搅拌,配成20m1浓度为25mg/ml的尿酸钠溶液。
4.3造模
参照Coderre氏等的方法,用1ml注射器在模型组、秋水仙碱组、本发明配方受试大鼠右后肢踝关节背侧从45°方向刺入胫骨肌腱内侧,将0.2ml浓度为25mg/ml的尿酸钠溶液注入到踝关节腔,形成痛风性关节炎模型。造模后2h大鼠活动减少,烦躁不安,进食进水次数减少,右侧踝关节明显充血肿胀,并伴随红、热表现,有的甚至将右足抬离地面,证实造模成功。
4.4动物给药
空白组不造模,不用药;模型组只造模,不用药;秋水仙碱组造模后给予秋水仙碱lmg·kg-1·次-1灌胃,本发明配方高剂量组造模后给予四本发 明配方浓缩药液12g·kg-1·次-1灌胃,本发明配方中剂量组造模后给予本发明配方浓缩药液6g·kg-1·次-1灌胃,本发明配方低剂量组造模后给予本发明配方浓缩药液3g·kg-1·次-1灌胃。秋水仙碱组和本发明配方组均为每天1次,连用7天,空白组与模型组给予等剂量生理盐水灌胃。
4.5观测指标和方法
4.5.1大体形态的观察:观察记录下大鼠的体重及精神变化,观察大鼠右下肢肿胀情况,并与健侧对比。
4.5.2病理学的观察及细胞因子的测定:在给药7天后将大鼠处死,将大鼠右下肢踝关节以下剥离。取100mg踝关节滑膜组织,放入2mlEP管中,加入PBS溶液1.5ml,并放入钢珠,封闭EP管,放入组织匀浆机中,匀浆10min,取出钢珠,后放入离心机,3000转,离心10min,用微量移液器将上清液移出,置于-80℃冰箱中保存待检测。剩余组织固定于10%的中性***缓冲液中24h,而后用5%硝酸脱钙48h,之后用净水清洗数次,以大头针能轻松刺入骨组织为度,最后将处置过的踝关节周围组织切取厚度为5mm的切片取出,按正常的实验步骤方法进行脱水透明,石蜡包埋,切片及HE染色之后,将切片置于显微镜下进行检查,观察踝关节周围组织的变化。将关节滑膜组织离心后所得上清液用ELISA试剂盒检测样本浓度。
4.6统计学方法
根据实验所测的各项指标结果,所有数据均采用SPSS18.0软件进行统计学数据分析。计量资料用均数±标准差表示,多样本组间比较符合正态分布采用单因素方差分析,各组间两两比较,采用LSD检验。检验水准为a=0.05,a=0.01,P<0.05表示差异有意义。P<0.01表示差异有显著性意义。
本发明效果经临床资料得到了充分证明,有关临床资料如下:
临床表现:
典型发作多因午夜足趾疼痛而惊醒,发病急骤,约2-3天疼痛达到高峰,疼痛性质如刀割或咬噬样剧烈疼痛。关节周围的软组织明显红肿发热,甚至局部不能些许震动或被单覆盖。该病首先发生于第一跖趾单关节的占总人数的60%一70%,且有90%以上患者在病程发展过程中会累及该部位;其次多 发的部位是跖趾、踝、膝、指、腕、肘等关节,较少见于肩、髋及脊椎等关节。痛风性关节炎反复发作会逐渐影响多个关节。有时可从受累的大关节中抽出关节积液。本病一年四季均可发病,但以春秋两季发病最多。在发病之前,只有少数病人可出现周身关节不适、疲乏或局部关节刺痛等征兆,但大多数患者无任何前驱症状。痛风性关节炎发作时多数仅表现为局部剧烈疼痛,全身症状不明显,少数人可出现头痛、低热、血沉快、白细胞升高等。长时间走路、饮酒、疲劳、感染、关节局部损伤、感染、手术等均可诱发痛风性关节炎。痛风的自然病程一般可持续数天至数周,痊愈后仅炎症皮肤区色泽变暗,而无任何症状。
(一)、病例入选标准:
根据临床症状、体征、辅助检查等结果,按1977年美国风湿病学会制定了关于急性痛风性关节炎的诊断标准:节液中有特异性尿酸盐结晶。②用化学方法或偏光显微镜证实痛风石中含尿酸盐结晶。③具备以下12项(临床、实验室、X线表现)中6项者:a急性关节炎发作在1次以上;b炎症反应在1天内达高峰;c单关节炎发作;d患病关节皮肤呈暗红色;e第1跖趾关节疼痛或肿胀;f单侧第1跖趾关节受累;g单侧跗骨关节受累;h可疑痛风石;i高尿酸血症;j关节不对称性肿胀(X线证实);k无骨质侵蚀的骨皮质下囊肿(X线证实);l关节炎发作期间时关节液微生物培养阴性。选择典型的患者30例,其中男19例,女11例,年龄为60-82岁。
(二)、诊断标准:
凡具有上述(一)所述症状者,并经节液检查、实验室、X线表现检查、等确诊急性痛风性关节炎突出。
(三)、疗效评定标准:
显效:临床症状明显减轻、实验室检查明显改变;
好转:临床症状减轻、实验室检查稍有改善;
无效:临床症状体征、实验室检查指标没有改善。
(四)、治疗方案
对诊断为急性痛风性关节炎的患者,用本发明的中药进行治疗,服用时,浓煎,早晚各一次,每次100-150ml,饭后一小时温服,5天为一个疗程, 2个疗程后统计疗效。
(五)、统计学处理:
按上述(四)治疗方案,口服本发明给出的中药,2个疗程后统计,临床使用该发明中药治疗急性痛风性关节炎30例,其中,显效8例,好转19例,总有效率达90.0%,表明该发明中药治疗急性痛风性关节炎效果显著,达到了临床治疗目的,并且在治疗过程中,未见明显不良反应。
(六)、结论
由上述情况表明,本发明是用于急性痛风性关节炎的有效药物,有效率达90.0%,无毒副作用,疗效稳定,安全可靠。
Claims (4)
1.一种治疗急性痛风性关节炎的中药,其特征在于该中药由重量计的:苍术10-20g,黄柏5-15g,川牛膝20-40g,薏苡仁20-40g,丹皮5-15g,赤芍10-20g,萆薢20-40g,土茯苓20-40g,威灵仙15-25g,制香附10-20g,穿山龙20-40g,木瓜15-25g,生山楂10-20g,红花10-20g,土元10-20g,地龙10-20g,元胡20-30g,生甘草5-10g制成。
2.根据权利要求1所述的一种治疗急性痛风性关节炎的中药,其特征在于该中药由重量计的:苍术15g,黄柏10g,川牛膝30g,薏苡仁30g,丹皮10g,赤芍15g,萆薢30g,土茯苓30g,威灵仙18g,制香附15g,穿山龙30g,木瓜18g,生山楂15g,红花15g,土元15g,地龙15g,元胡30g,生甘草6g制成。
3.根据权利要求1所述的一种治疗急性痛风性关节炎的中药,其特征在于该中药由重量计的:苍术10g,黄柏15g,川牛膝40g,薏苡仁40g,丹皮15g,赤芍20g,萆薢40g,土茯苓20g,威灵仙25g,制香附10g,穿山龙20g,木瓜25g,生山楂20g,红花10g,土元20g,地龙10g,元胡30g,生甘草10g制成。
4.根据权利要求1所述的一种治疗急性痛风性关节炎的中药,其特征在于该中药由重量计的:苍术20g,黄柏5g,川牛膝20g,薏苡仁20g,丹皮5g,赤芍10g,萆薢20g,土茯苓40g,威灵仙15g,制香附20g,穿山龙40g,木瓜15g,生山楂10g,红花20g,土元10g,地龙20g,元胡20g,生甘草5g制成。
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