CN116549522A - 一种中药组合物在痛风中的用途 - Google Patents
一种中药组合物在痛风中的用途 Download PDFInfo
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Abstract
本发明提供了一种中药组合物在痛风中的用途,涉及中药领域,该复方川归酊的原料包括:当归、川芎、铁丝威灵仙、醋乳香、醋没药、大黄、续断、杜仲、延胡索、桂枝、细辛、乌梅、樟脑、冰片。该复方川归酊对于痛风有着良好的药效,可以用于制备治疗痛风的相关中药制剂;同时该复方川归酊还能与其他药物,如伸筋片进行联合使用,从而协同治疗痛风。
Description
技术领域
本发明涉及中药领域,具体涉及一种中药组合物在痛风中的用途。
背景技术
复方川归酊由当归、川芎、铁丝威灵仙、乳香(制)、没药(制)、大黄、续断、杜仲、延胡索、桂枝、细辛、乌梅、樟脑、冰片组成,具有祛风散寒,除湿通络,活血止痛的功能,适用于风寒湿痹引进的关节肌肉疼痛,肿胀,活动不利的辅助治疗。
发明CN1628792A公开了复方川归酊的处方、制法及用途。该专利处方组成中乳香和没药用的生品(未炮制),并公开了其用于治疗骨质增生、肩周炎、类风湿性关节炎等的外用中药及其制备方法。指出该发明祛风散寒、除湿止痛、活盘通络,能广泛用于关节肌肉疼痛、关节红肿、肢体麻木以及跌打损伤等病症,还可以用于各种炎症性疼痛,神经痛等病症。经北京几大医疗机构临床验证,总有效率达90%以上,其中骨质增生有效率为85%,肩周炎93.3%,类风湿性关节炎有效率为86.7%,软组织损伤有效率为100%。但该发明并无复方川归酊治疗痛风的相关记载。
痛风是由单钠尿酸盐沉积所致的晶体相关性关节病,是一种常见且复杂的关节炎类型,患者经常会在夜晚出现突然性的关节疼,发病急,关节部位出现疼痛、水肿、红肿和炎症,疼痛感慢慢减轻直至消失,持续几天或几周不等。痛风发作与体内尿酸浓度有关,痛风会在关节腔等处形成尿酸盐沉积,进而引发急性关节疼痛。治疗痛风的药物主要有非甾类抗炎药、糖皮质激素,以减轻疼痛为主,但目前药物治疗方法较少;减少食用高嘌呤食物、高脂类食物,如肉类、野味、海鲜、含酵母食物和饮料等,食用低嘌呤食物是比较普遍和健康的治疗方法。
目前为止,并无复方川归酊治疗痛风的相关研究。因此,针对复方川归酊,进一步对其进行探究该方在其他层面的用途,如痛风,对拓展药物的进一步开发利用而言十分必要。
发明内容
本发明针对现有技术存在的问题,提供了一种中药组合物在痛风中的用途。
为实现上述目的,本发明采用的技术方案如下:
本发明提供了复方川归酊在制备治疗痛风的药物中的应用,所述复方川归酊的原料包括:当归、川芎、铁丝威灵仙、醋乳香、醋没药、大黄、续断、杜仲、延胡索、桂枝、细辛、乌梅、樟脑、冰片。
进一步地,按重量份数计,所述复方川归酊的原料包括:当归40-60份、川芎40-60份、铁丝威灵仙60-80份、醋乳香25-35份、醋没药25-45份、大黄25-45份、续断25-45份、杜仲25-45份、延胡索35-45份、桂枝25-35份、细辛3-7份、乌梅18-22份、樟脑8-12份、冰片8-12份。
优选地,按重量份数计,所述复方川归酊的原料包括:当归50份、川芎50份、铁丝威灵仙70份、醋乳香30份、醋没药30份、大黄30份、续断30份、杜仲30份、延胡索40份、桂枝30份、细辛5份、乌梅20份、樟脑10份、冰片10份。
进一步地,所述当归和醋乳香的重量比为40-60:25-35。优选为5:3。
进一步地,所述当归和延胡索的重量比为40-60:35-45。优选为5:4。
进一步地,所述醋乳香的制备步骤包括:取净乳香,照醋炙法炒至表面光亮。
进一步地,所所述醋没药的制备步骤包括:取净没药,照醋炙法炒至表面光亮。
值得说明的是,上述醋炙法参照中国药典通则0213进行,即:取待炮炙品,加醋拌匀,闷透,置炒制容器内,炒至规定的程度时,取出,放凉。
进一步地,所述药物的剂型包括片剂、膏剂、透皮剂、颗粒剂、液体剂或丸剂。
进一步地,所述药物还包括医学上可接受的辅料。
进一步地,所述复方川归酊的制备方法包括以下步骤:将樟脑、冰片用乙醇溶解,将其余药材粉碎后,提取,合并提取液,静置,滤过,浓缩,加入樟脑和冰片的乙醇溶液,并继续加入乙醇定容,搅匀、静置、冷藏、滤过、灌装,即得。
在一些具体的实施方式中,所述复方川归酊的制备方法包括以下步骤:将樟脑、冰片用乙醇溶解,将其余当归等十二味药材粉碎成粗粉,用乙醇回流提取,合并提取液,静置,滤过,滤液回收乙醇,浓缩至相对密度1.01-1.10(60℃),加入樟脑和冰片的乙醇溶液,并加乙醇至1000ml,搅匀,静置,冷藏,滤过,灌装,即得。
在另一些具体的实施方式中,所述复方川归酊的制备方法包括以下步骤:将樟脑、冰片用乙醇溶解,将其余当归等十二味药材粉碎成粗粉,用乙醇回流提取3次,合并提取液,静置24h,滤过,滤液回收乙醇,浓缩至相对密度1.01-1.10(60℃),加入樟脑和冰片的乙醇溶液,并加乙醇至1000ml,搅匀,静置24h,冷藏,滤过,灌装,即得。
进一步地,本发明还提供了复方川归酊和伸筋片在制备治疗痛风的药物中的应用,所述治疗痛风的药物包括内服药和外用药;所述内服药为伸筋片;所述外用药为复方川归酊;所述复方川归酊的原料包括:当归、川芎、铁丝威灵仙、醋乳香、醋没药、大黄、续断、杜仲、延胡索、桂枝、细辛、乌梅、樟脑、冰片。
进一步地,所述伸筋片为市售伸筋片。
进一步地,所述伸筋片口服,0.75g/次,3次/日,所述复方川归酊外用,涂于患处,每次5-10滴(约含药材0.11-0.22g),1-2次/日。
本发明所取得的技术效果是:
1.本发明的复方川归酊与CN1628792A的区别为,乳香、没药采用炮制品。乳香、没药外用一般使用生品入药,二者醋制后可减少胃刺激性,增加活血止痛的作用。本发明的复方川归酊能够有效治疗痛风。
2.痛风中医称痛痹、历节、白虎历节、风痹、白虎风。与普通关节痛等病因、症状、治疗均不相同;据《格致余论·痛风论》记载:“彼痛风者,大率因血受热,已自沸腾,其后或涉冷水,或立湿地,或扇取凉,或卧当风,寒凉外搏,热血得寒,汗浊凝涩,所以作痛,夜则痛甚,行于阴也。”据《医学准绳六要》记载:“痛风,即据《黄帝内经素问》记载痛痹……古云三气合而为痹。今人多内伤,气血亏损,湿痰阴火,流滞经络,或在四肢,或客腰背,痛不可当,一名白虎历节风是也。”据《景岳全书·脚气》记载中认为,本病外由阴寒水湿,湿邪袭皮肉筋脉,内由平素肥甘过度,湿壅下焦;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。
痛风发病以脾肾两虚为本,湿热毒瘀为标,证属正虚邪实。如果先天禀赋不足,后天嗜食膏粱厚味,日久伤脾,或年老脾肾功能失调,则外感或内生湿热毒邪流窜经络,攻注骨节,着于经脉,终致湿热毒瘀交互为患。痛风急性发作时关节、足背、足跟、踝、指、腕等小关节红肿剧痛,形成痛风石。急则治其标,缓则治其本。急性发作宜活血止痛,除湿通络,祛风消肿。
本发明中,君药:
当归味甘、辛,性温,补血活血、调经止痛,据《日华子本草》记载:治一切风,一切血,补一切劳,去恶血,养新血,及主症癖;据《本草分经》记载:辛、甘、苦,温。入心、肝、脾。治冲脉带脉为病,为血中气药。血滞能通,血虚能补,血枯能润,血乱能抚,使气血各有所归。散内寒,补不足,去瘀生新,润燥滑肠。
延胡索味辛、苦,性温。归心、肝、肺经。功效活血、行气、止痛。据《日华子本草》记载:除风,治气,暖腰膝,破症癖,扑损瘀血,落胎及暴腰痛。据《本草纲目》记载:延胡索,味苦微辛,气温,入手足太阴,厥阴四经,能行血中气滞,气中血滞,故专治一身上下诸痛,用之中的,妙不可言。
方中当归补血活血,调经止痛,治一切风,一切血,去恶血,养新血,去瘀生新,延胡索行血中气滞,气中血滞,故专治一身上下诸痛,用之中的。二者合用,活血行气止痛,共为君药。
臣药:
川芎味辛、性温。归肝、胆、心包经。功效活血行气、祛风止痛。据《神农本草经》记载:味辛,温。主治中风入脑头痛,寒痹,筋挛缓急,金创,妇人血闭无子。据《日华子本草》记载:畏黄连。治一切风,一切气,一切劳损,一切血。补五劳,壮筋骨,调众脉,破疗结宿血,养新血,长肉,鼻洪吐血及溺血,痔瘘,脑痈,发背,瘰沥,瘿赘,疮疥,及排脓,消瘀血。
铁丝威灵仙味辛、苦、咸,性温,归膀胱经、肝经。功效祛风湿,通经络,消痰涎,散癖积,治痛风,症瘕积聚,破伤风,扁桃体炎,诸骨鲠咽。
没药(制)味苦,性平。归心、肝、肺经。功效活血止痛、消肿生肌。据《本草蒙筌》记载:味甘、辛,气平。无毒。主坠堕跌打损伤,疗痈疽疮瘘溃腐。破血立效。止痛如神。据《本草纲目》记载:乳香活血,没药散血,皆能止痛消肿生肌。故二药每相兼用。散血消肿,定痛生肌。
乳香(制)味辛、苦,性温,入心、肝、脾经。功效活血止痛、消肿生肌。据《名医别录》记载:微温。疗风水毒肿,去恶气。据《本草新编》记载:乳香,味辛、苦,气温,阳也,无毒。入脾、肺、心、肝、肾五脏。疗诸般恶疮及风水肿毒,定诸经卒痛并心腹急疼。亦入散膏,止痛长肉。据《医学衷中参西录》记载:气香窜,味淡,故善透窍以理气。没药:气则淡薄,味则辛而微酸,故善化阏瘀以理血。其性皆微温,二药并用为宣通脏腑流通经络之要药。其通气活血之力,又善治风寒湿痹,周身麻木,四肢不遂及一切疮疡肿疼,或其疮硬不疼。外用为粉以敷疮疡,能解毒、消肿、生肌、止疼,虽为开通之品,不至耗伤气血,诚良药也。
细辛味辛,性温。归肺、肾经。功效散寒解表、祛风止痛、温肺化饮、通窍开闭。据《神农本草经》记载:味辛,温。主治咳逆。头痛,脑动,百节拘挛,风湿痹痛,死肌。据《药性解》记载:味辛,性温,无毒,入心、肝、胆、脾四经。止少阴合病之首痛,散三阳数病之风邪,主肢节拘挛,风寒湿痹。
乌梅味酸,性平。归肝、脾、肺、大肠经。功效敛肺、涩肠、生津、安蛔。据《神农本草经》记载:味酸,平。主下气,除热烦满,安心,肢体痛,偏枯不仁,死肌,去青黑痣,恶疾。
大黄味苦、性寒。归脾、胃、大肠、肝、心包经。功效泻热通肠、凉血解毒、逐瘀通经。据《神农本草经》记载:味苦,寒。主下瘀血,下闭,寒热,破癥瘕积聚。据《日华子本草》记载:通宣一切气,调血脉,利关节,泄壅带水气,四肢冷热不调,温瘴热候,利大小便,并傅一切疮疥痈毒。
方中川芎活血行气、祛风止痛;铁丝威灵仙祛风湿,通经络,消痰涎,散癖积;醋乳香、醋没药活血止痛、消肿生肌,二药并用为宣通脏腑流通经络之要药,其通气活血之力,又善治风寒湿痹,周身麻木,四肢不遂及一切疮疡肿疼,外用为粉以敷疮疡,能解毒、消肿、生肌、止疼,虽为开通之品,不至耗伤气血,诚良药也;细辛散寒解表、祛风止痛、温肺化饮、通窍开闭;乌梅主肢体痛,偏枯不仁,去恶疾;大黄调血脉,利关节,泄壅带水气。七药合用,活血、止痛、消肿、祛风之力更强。
佐药:
续断微苦、甘、辛,性温。归肝、肾经。功效补肝肾、行血脉、续筋骨。据《日华子本草》记载:助气,调血脉,补五劳七伤,破症结瘀血,消肿毒。据《本草求真》记载:[批]温补肝肾,以散筋骨血气凝滞。据《本草分经》记载:苦、辛,微温。补肝肾,通血脉,理筋骨,暖子宫,缩小便,止遗泄,破瘀血,治金疮、折跌。补而不滞,行而不泄。
杜仲味甘,性温。归肝、肾经。功效补益肝肾、强筋壮骨、调理冲任、固经安胎。据《名医别录》记载:味甘,温,无毒。主治脚中酸疼痛,不欲践地。据《本经疏证》记载:杜仲之治曰主腰脊痛,别于因风寒湿痹而为腰脊痛也。曰补中益精气,坚筋骨,强志以能主腰脊痛而究极言之也。即别录所注脚中酸疼,不欲践地,尚是腰脊以内事,盖惟下一欲字,已可见其能而不欲,非欲而不能也。夫脚之用力皆出于腰,设使欲而不能,是脚不遵腰令,今曰不欲,则犹腰之令不行于脚,故曰尚是腰脊以内事。
樟脑味辛,性温。入心、脾经。功效通关窍,利滞气,辟秽浊,杀虫止痒,消肿止痛。具有通关窍,利滞气,辟秽浊,杀虫止痒,消肿止痛之功效。主治热病神昏,中恶猝倒,痧胀吐泻腹痛,寒湿脚气,疥疮顽癣,秃疮,冻疮,臁疮,水火烫伤,跌打伤痛,牙痛,风火赤眼。据《普济方》记载:“作膏治诸恶疮及打扑损伤,风湿脚气等症。”
冰片味辛、苦,性凉。归心、肺经。功效开窍醒神、散热止痛、明目去翳。据《本草求真》记载:[批]除骨髓内伏风,邪自内出外。据《本草分经》记载:辛、香。善走。体温用凉,先入肺,传于心脾,而透骨通窍,散郁火,辟邪,消风化湿。
方中续断补肝肾、行血脉、续筋骨,消肿毒;杜仲补益肝肾、强筋壮骨,主治脚中酸疼痛,不欲践地;二药合用,佐助君药、臣药的同时,使药力行而不泄,湿邪毒去而正气留守无伤。樟脑通关窍,利滞气,辟秽浊,消肿止痛;冰片透骨通窍,散郁火,辟邪,消风化湿;二药共用既能增强君药、臣药的作用,又可引诸药直达病所。
使药:
桂枝味辛、甘,性温。归心、肺、膀胱经。功效发汗解肌、温通经脉、助阳化气。据《本草衍义》记载:据《素问》记载云:辛甘发散为阳。据《神农本草经百种录》记载:味辛,温。主百病,言百病用之得宜,皆有益也。养精神,通达脏腑,益在内也。和颜色,调畅血脉,益在外也。为诸药先聘通使。辛香四达,引药以通经络。寒气之郁结不舒者,惟辛温可以散之。桂性温补阳,而香气最烈,则不专于补,而又能驱逐阴邪。凡阴气所结,能与药相拒,非此不能入也。
方中桂枝温通经脉,辛香四达,为诸药先聘通使,引药以通经络。
全方诸药合用,共奏活血止痛,除湿通络,祛风消肿之功效。
3.本发明研究发现,复方川归酊能够有效治疗痛风,同时,将其与伸筋片能够进行联合用药,共同使用具有协同治疗痛风的效果。
具体实施方式
以下通过特定的具体实例说明本发明的实施方式,本领域技术人员可由本说明书所揭露的内容轻易地了解本发明的其他优点与功效。本发明还可以通过另外不同的具体实施方式加以实施或应用,本说明书中的各项细节也可以基于不同观点与应用,在没有背离本发明的精神下进行各种修饰或改变。
在进一步描述本发明具体实施方式之前,应理解,本发明的保护范围不局限于下述特定的具体实施方案;还应当理解,本发明实施例中使用的术语是为了描述特定的具体实施方案,而不是为了限制本发明的保护范围。
当实施例给出数值范围时,应理解,除非本发明另有说明,每个数值范围的两个端点以及两个端点之间任何一个数值均可选用。除非另外定义,本文中使用的所有技术和科学术语具有与本发明所属技术领域的普通技术人员通常理解的相同意义。
值得说明的是,本发明中使用的原料均为普通市售产品,因此对其来源不做具体限定。
实施例1
复方川归酊:按重量份数计,原料包括:当归40份、川芎40份、铁丝威灵仙60份、醋乳香25份、醋没药25份、大黄25份、续断25份、杜仲25份、延胡索35份、桂枝25份、细辛3份、乌梅18份、樟脑8份、冰片8份。
上述复方川归酊的制备方法包括以下步骤:将樟脑、冰片用乙醇溶解,将其余当归等十二味药材粉碎成粗粉,用乙醇回流提取3次,合并提取液,静置24h,滤过,滤液回收乙醇,浓缩至相对密度1.01-1.10(60℃),加入樟脑和冰片的乙醇溶液,并加乙醇至1000ml,搅匀,静置24h,冷藏,滤过,灌装,即得。
实施例2
复方川归酊:按重量份数计,原料包括:当归60份、川芎60份、铁丝威灵仙80份、醋乳香35份、醋没药45份、大黄45份、续断45份、杜仲45份、延胡索45份、桂枝35份、细辛7份、乌梅22份、樟脑12份、冰片12份。
上述复方川归酊的制备方法包括以下步骤:将樟脑、冰片用乙醇溶解,将其余当归等十二味药材粉碎成粗粉,用乙醇回流提取3次,合并提取液,静置24h,滤过,滤液回收乙醇,浓缩至相对密度1.01-1.10(60℃),加入樟脑和冰片的乙醇溶液,并加乙醇至1000ml,搅匀,静置24h,冷藏,滤过,灌装,即得。
实施例3
复方川归酊:按重量份数计,原料包括:当归50份、川芎50份、铁丝威灵仙70份、醋乳香30份、醋没药30份、大黄30份、续断30份、杜仲30份、延胡索40份、桂枝30份、细辛5份、乌梅20份、樟脑10份、冰片10份。
上述复方川归酊的制备方法包括以下步骤:将樟脑、冰片用乙醇溶解,将其余当归等十二味药材粉碎成粗粉,用乙醇回流提取3次,合并提取液,静置24h,滤过,滤液回收乙醇,浓缩至相对密度1.01-1.10(60℃),加入樟脑和冰片的乙醇溶液,并加乙醇至1000ml,搅匀,静置24h,冷藏,滤过,灌装,即得。
实施例4
一种药物组合物,包括复方川归酊和伸筋片,伸筋片口服,0.75g/次,3次/日,复方川归酊外用,涂于患处,每次5滴(约含药材0.11g),1次/日。
复方川归酊:按重量份数计,原料包括:当归50份、川芎50份、铁丝威灵仙70份、醋乳香30份、醋没药30份、大黄30份、续断30份、杜仲30份、延胡索40份、桂枝30份、细辛5份、乌梅20份、樟脑10份、冰片10份。
上述复方川归酊的制备方法包括以下步骤:将樟脑、冰片用乙醇溶解,将其余当归等十二味药材粉碎成粗粉,用乙醇回流提取3次,合并提取液,静置24h,滤过,滤液回收乙醇,浓缩至相对密度1.01-1.10(60℃),加入樟脑和冰片的乙醇溶液,并加乙醇至1000ml,搅匀,静置24h,冷藏,滤过,灌装,即得。
市售伸筋片,由吉林华康药业股份有限公司提供(国药准字Z10940002)。
对比例1
与实施例3的区别仅在于,将醋没药替换为生没药,将醋乳香替换为生乳香。
对比例2
与实施例3的区别仅在于,将醋没药替换为炒没药(炒制:取净没药置锅内,用文火炒至表面光亮时,取出,放凉。),将醋乳香替换为炒乳香(取拣净的乳香,置锅内用文火炒至表面稍见熔化点,略呈黄色,取出放凉)。
对比例3
骨痛灵酊(由雪上一枝蒿、干姜、龙血竭、乳香、没药、冰片组成。具有温经散寒,祛风活血,通络止痛功能。适用于腰、颈椎骨质增生,骨性关节病,肩周炎,风湿性关节炎)。
对比例4
市售伸筋片,由吉林华康药业股份有限公司提供(国药准字Z10940002)。
效果评价
(一)对微晶型尿酸钠诱导的急性痛风性关节炎的作用
1.实验材料
1.1药物
实验药:将上述实施例1-4和对比例1-2的组合物分别混合制备得到实验药,备用。
对比例3组:骨痛灵酊,云南圣科药业有限公司生产,批准文号国药准字Z53021244;
对比例4组:伸筋片,吉林华康药业股份有限公司生产,批准文号国药准字Z10940002。临用时将片剂碾碎,以等量蒸馏水分散开,用时摇匀,4℃保存。
对照药:阳性对照组:秋水仙碱片,云南植物药业有限公司生产,批准文号国药准字H53020166。临用时将片剂碾碎,以等量蒸馏水分散开,用时摇匀,4℃保存。
1.2主要试剂
结晶尿酸钠(MSU)购自西格玛奥德里奇(上海)贸易有限公司;TNF-α Elisa试剂盒、IL-6 Elisa试剂盒、IL-1β Elisa试剂盒、PGE2 Elisa试剂盒均购于南京建成生物工程研究所。
1.3实验动物
SD大鼠,体重:220~250g,级别:SPF级。购买自长春市亿斯实验动物技术有限责任公司,动物生产合格证号:SCXK(吉)-2020-0002。
1.4实验仪器
酶标仪(上海闪谱生物科技有限公司);隔水式培育箱(宁国沙鹰科学仪器有限公司);光学显微镜(日本尼康);电子天平(华志电子科技有限公司);注射器(1ml、5ml、10ml等规格)若干;消毒物品(酒精、碘伏、纱布)若干。
2.实验方法
2.1动物分组
取健康SD大鼠,110只,雌雄各半,自然采光,适应性喂养5天,观察各组大鼠一般情况并将其随机按体重均匀分为11组,分别为空白对照组、模型组、阳性药组、给药各组(实施例1-4和对比例1-4),每组10只,并用苦味酸着色剂分别标记各组中每只动物。
2.2造模
参照文献方法建立的高尿酸血症并急性痛风性关节炎大鼠模型的方法进行造模。除空白对照组外,大鼠腹腔注射戊巴比妥钠(约35mg/kg)麻醉,选右踝关节内侧后方为穿刺点,针口斜面朝前上方与胫骨成45°夹角穿入踝关节腔。除阴性对照组外,其余各组向关节腔注入0.2ml 2.5mg/ml的MSU混悬液,以对侧鼓起为注入标准,诱导AGA模型,阴性对照组注入等体积的生理盐水。造模后大鼠关节红肿,不欲行动,步履蹒跚或者跛行,饮食饮水较空白对照组少,大鼠出现跛行,受试下肢刚触及地面甚至受试下肢离开地面,三足着地行走为造模成功。
2.3给药
造模成功后开始治疗,外用的药物用分液器将实验药物涂于大鼠右踝,口服的药物灌胃给药。实施例1-3和对比例1-3每次外涂1mL,每天3次;实施例4每次外涂复方川归酊1mL,每天3次,另灌胃给予伸筋片混悬液,每天1次;对比例4组灌胃给予伸筋片混悬液,每天1次;阳性对照组灌胃给予秋水仙碱混悬液,每天1次;空白对照组和模型对照组均外涂60%乙醇,每次外涂1mL,每天3次;所有组连续给药7天。秋水仙碱给药剂量为0.3mg/kg,伸筋片给药剂量为0.25g/kg。
3.观察指标
3.1关节肿胀度
以记号笔在踝关节上方约0.5cm处标记测量上限,分别测定致炎前及致炎后1h、3h、5h、24h的足容积,计算关节肿胀度。
关节肿胀度(ml)=Vt-Vn
(Vn、Vt分别代表致炎前后右后足容积值)
3.2血清中炎症因子水平检测
测量结束后,以戊巴比妥钠约50mg/kg麻醉大鼠,腹主动脉取血5ml,3000r/min离心10min取血清,根据ELISA试剂盒说明书测定各组大鼠血清中TNF-α、IL-6、IL-1β、PGE2等炎症因子水平。
4.实验结果
4.1关节肿胀度
表1 大鼠关节肿胀度情况
4.2血清中炎症因子水平检测
表2 大鼠血清中TNF-α和IL-1β的情况
表3 大鼠血清中IL-6和PGE2的情况
(二)对二甲苯致小鼠耳廓肿胀的作用
1.实验材料
1.1药物
实验药:将上述实施例1-4和对比例1-2的组合物分别混合制备得到实验药,备用。
对比例3组:骨痛灵酊云南圣科药业有限公司生产,批准文号国药准字Z53021244;
对比例4组:伸筋片,吉林华康药业股份有限公司生产,批准文号国药准字Z10940002。临用时将片剂碾碎,以等量蒸馏水分散开,用时摇匀,4℃保存。
1.2主要试剂
二甲苯(分析纯)购自天津市富宇精细化工有限公司;IL-1β Elisa试剂盒、PGE2Elisa试剂盒、IL-6 Elisa试剂盒、TNF-α Elisa试剂盒均购于南京建成生物工程研究所。
1.3实验动物
昆明小鼠,雌雄各半,体重:18~22g,SPF级。购买自长春市亿斯实验动物技术有限责任公司,动物生产合格证号:SCXK(吉)-2020-0002。
1.4实验仪器
酶标仪(上海闪谱生物科技有限公司);电子天平(华志电子科技有限公司);SC-3612型低速离心机(安徽中科中佳科学仪器有限公司);TP1020型生物组织脱水机(Leica公司);H.H.S型电热恒温水浴锅(上海医疗器械五厂)。
2、实验方法
2.1动物分组
取健康小鼠,自然采光,适应性喂养5天,观察各组小鼠一般情况并将其随机分为10组,分别为空白对照组、模型组、给药各组(实施例1-4和对比例1-4),每组10只,并用苦味酸着色剂分别标记各组中每只动物。
2.2给药
分组后开始给药,外用的药物用分液器将实验药物涂于患处,口服的药物灌胃给药。实施例1-3和对比例1-3每次外涂1mL,每天3次;实施例4每次外涂复方川归酊1mL,每天3次,另灌胃给予伸筋片混悬液,每天1次;对比例4组灌胃给予伸筋片混悬液,每天1次;空白对照组和模型对照组均外涂60%乙醇,每次外涂1mL,每天3次;所有组连续给药5天。伸筋片给药剂量为0.4g/kg。
2.3造模
末次给药后1h,右耳滴二甲苯0.02ml/只致炎,左耳作为空白对照。15min后脱颈椎处死,用直径6mm的打孔器打下左右两耳片,称量质量,以两耳片质量差值作为肿胀度。
3.评价指标
3.1耳廓肿胀度
肿胀度(g)=右耳重(g)-左耳重(g)
3.2血清中炎症因子水平检测
造模24h后,以戊巴比妥钠约50mg/kg麻醉小鼠,腹主动脉取血5ml,3000r/min离心10min取血清,根据ELISA试剂盒说明书测定各组小鼠血清中TNF-α、IL-6、IL-1β、PGE2等炎症因子水平。
4.实验结果
4.1耳廓肿胀度
表4 小鼠耳廓肿胀度情况
4.2血清中炎症因子水平检测
表5 小鼠血清中TNF-α和IL-6的情况
表6 小鼠血清中IL-1β和PGE2的情况
(三)对冰醋酸致小鼠扭体的作用
1.实验材料
1.1药物
同“对二甲苯致小鼠耳廓肿胀的作用”药物。
1.2主要试剂
氯化钠注射液购自辰欣药业股份有限公司;冰醋酸购自天津市富宇精细化工有限公司。
1.3实验动物
昆明种小鼠,体重:18~22g,雌雄各半,级别:SPF级。购买自长春市亿斯实验动物技术有限责任公司,动物生产合格证号:SCXK(吉)-2020-0002。
1.4主要仪器
电子天平(华志电子科技有限公司)。
2.实验方法
2.1动物分组
同“对二甲苯致小鼠耳廓肿胀的作用”动物分组方法。
2.2动物给药
同“对二甲苯致小鼠耳廓肿胀的作用”动物给药方法。
2.3小鼠扭体模型的制备
末次给药后1h,腹腔注射0.7%冰醋酸0.1ml/10g,观察记录注射致痛剂后15min内小鼠扭体次数并计算各组抑制率。
3.观察指标
①扭体次数。
②抑制率=(空白对照组平均扭体次数-药物组平均扭体次数)/空白对照组平均扭体次数*100%。
4.实验结果
表7 小鼠扭体次数和扭体抑制率情况
(四)复方川归酊对小鼠热板法镇痛的作用
1.实验材料
1.1药物
同“对二甲苯致小鼠耳廓肿胀的作用”药物。
1.2主要试剂
氯化钠注射液购自辰欣药业股份有限公司;冰醋酸购自天津市富宇精细化工有限公司。
1.3实验动物
昆明种雌性小鼠,体重:18~22g,级别:SPF级。购买自长春市亿斯实验动物技术有限责任公司,动物生产合格证号:SCXK(吉)-2020-0002。
1.4主要仪器
电子天平(华志电子科技有限公司),小鼠光热致痛仪(本实验室自制),电热干燥箱,热板等。
2.实验方法
2.1动物分组
取雌性小鼠置于热板仪内,温度控制在(55±0.5)℃,测定小鼠痛阈值,测2次,每隔5min测量1次,以小鼠舔后足作为观察指标,筛选出5-30s内有痛反应的小鼠100只。随机分为10组,每组10只。
2.2动物给药
除空白对照组和模型组灌胃给予生理盐水外,其他各组同“对二甲苯致小鼠耳廓肿胀的作用”给药方法,连续给药5d。
2.3小鼠热板法镇痛模型的制备
各组于末次给药后2h,放在事先加热到(55±0.5℃)的热板上,以舔后足为痛反应的指标,记录痛阈值。每鼠测定痛阈值2次(间隔10min),取其平均值。
2.4观察指标
①痛阈值:以舔后足为痛反应的指标,出现痛反应时即停表,记录时间即该鼠的痛阈值。如痛阈超过60s以60s计。
4.实验结果
表8 小鼠痛阈值和痛阈提高率情况
由上述各试验可知,本发明的中药组合物复方川归酊对微晶型尿酸钠诱导的急性痛风性关节炎、二甲苯致小鼠耳廓肿胀、冰醋酸致小鼠扭体以及小鼠热板法镇痛均具有良好疗效,可见本发明的复方川归酊对痛风有着良好的治疗效果。而由对比例3和各实施例的比较可知,痛风与风湿性关节炎等疾病并不相同,针对风湿性关节炎等的药物其对于痛风并不一定具有同等治疗的作用。而由本发明对比例4与实施例3-4进行比较可知,复方川归酊和伸筋片在治疗痛风层面存在协同作用。
最后应当说明的是,以上内容仅用以说明本发明的技术方案,而非对本发明保护范围的限制,本领域的普通技术人员对本发明的技术方案进行的简单修改或者等同替换,均不脱离本发明技术方案的实质和范围。
Claims (10)
1.复方川归酊在制备治疗痛风的药物中的应用,其特征在于:所述复方川归酊的原料包括:当归、川芎、铁丝威灵仙、醋乳香、醋没药、大黄、续断、杜仲、延胡索、桂枝、细辛、乌梅、樟脑、冰片。
2.根据权利要求1所述的应用,其特征在于:按重量份数计,所述复方川归酊的原料包括:当归40-60份、川芎40-60份、铁丝威灵仙60-80份、醋乳香25-35份、醋没药25-45份、大黄25-45份、续断25-45份、杜仲25-45份、延胡索35-45份、桂枝25-35份、细辛3-7份、乌梅18-22份、樟脑8-12份、冰片8-12份。
3.根据权利要求1所述的应用,其特征在于:按重量份数计,所述复方川归酊的原料包括:当归50份、川芎50份、铁丝威灵仙70份、醋乳香30份、醋没药30份、大黄30份、续断30份、杜仲30份、延胡索40份、桂枝30份、细辛5份、乌梅20份、樟脑10份、冰片10份。
4.根据权利要求1所述的应用,其特征在于:所述当归和醋乳香的重量比为40-60:25-35。
5.根据权利要求1所述的应用,其特征在于:所述醋乳香的制备步骤包括:取净乳香,照醋炙法炒至表面光亮。
6.根据权利要求1所述的应用,其特征在于:所述醋没药的制备步骤包括:取净没药,照醋炙法炒至表面光亮。
7.根据权利要求1所述的应用,其特征在于:所述药物的剂型包括片剂、膏剂、透皮剂、颗粒剂、液体剂或丸剂。
8.根据权利要求1所述的应用,其特征在于:所述药物还包括医学上可接受的辅料。
9.根据权利要求1所述的应用,其特征在于:所述复方川归酊的制备方法包括以下步骤:将樟脑、冰片用乙醇溶解,将其余药材粉碎后,提取,合并提取液,静置,滤过,浓缩,加入樟脑和冰片的乙醇溶液,并继续加入乙醇定容,搅匀、静置、冷藏、滤过、灌装,即得。
10.复方川归酊和伸筋片在制备治疗痛风的药物中的应用,其特征在于:所述治疗痛风的药物包括内服药和外用药;所述内服药为伸筋片;所述外用药为复方川归酊;所述复方川归酊的原料包括:当归、川芎、铁丝威灵仙、醋乳香、醋没药、大黄、续断、杜仲、延胡索、桂枝、细辛、乌梅、樟脑、冰片。
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