CN117018069A - 一种治疗风湿性关节炎的外用壮药组合物及其制备方法与应用 - Google Patents
一种治疗风湿性关节炎的外用壮药组合物及其制备方法与应用 Download PDFInfo
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Abstract
本发明涉及民族医药技术领域,具体是一种治疗风湿性关节炎的外用壮药组合物及其制备方法与应用。本申请的中药组合物以藤杜仲、藤当归、宽筋藤、肿节风、海风藤、山霸王、鸡血藤、伸筋草、三钱三、大风艾、丢了棒、红鱼眼、半枫荷为原料。具有散寒毒,除湿毒,祛风毒之作用,适用于风寒湿毒所致骆芡(骨关节炎)、滚克(类风湿关节炎)等。症见:关节肢体疼痛、重着,冷痛,或有肿胀,痛处游走不定,局部畏寒,得寒痛剧,得热痛减,皮色不红,关节屈伸不利。对类风湿关节炎、骨关节炎具有抑制炎症、减轻关节肿胀、缓解关节疼痛等作用。
Description
技术领域
本发明涉及民族医药技术领域,具体是一种治疗风湿性关节炎的外用壮药组合物及其制备方法与应用。
背景技术
风湿病是一组累及全身骨关节及其周围软组织的慢性疾病,在中老年群体中发病率高。尽管由于早期的诊断,积极有效的治疗,在过去的几十年里,风湿免疫病患者的死亡率明显下降,然而,和正常人群相比,风湿免疫病患者的死亡率仍然很高。流行病学证据显示较高的死亡率归因于风湿免疫病患者较高的并发症,尤其是心血管并发症,如缺血性心脏疾病、心瓣膜疾病、心肌病、心包疾病和心脏传导系统的异常。
由于疗效确切、药性稳定、不良反应率低,用于风湿病治疗的中药外用膏剂越来越受到国内外学者的关注。调查研究表明,风湿病是临床上常见的疑难病、多发病之一,目前尚无理想的根治药物。西医多使用非甾体类抗炎药、糖皮质激素及免疫抑制剂等,主要通过抗炎、镇痛和免疫抑制作用来减轻炎症反应。但风湿病缠绵难愈,且长期服用上述药物会对人体重要的组织和脏器产生不同程度的毒副作用。
风湿病多为自身免疫相关的难治性疾病,其病因和发病机制尚不明确,目前还没有特效或根治方法。西医治疗风湿病多选用非甾体类抗炎药消炎镇痛、糖皮质类激素控制病情、免疫抑制剂延缓或阻止病情的发展,但此三类药物均有明显的副作用,患者往往难以接受。而中药外用膏剂具有疗效确切、药性稳定、毒副作用低等特点,在风湿免疫性疾病中的应用日益频繁,但在研究与应用过程中仍存在一些问题亟待关注与解决,如西药治疗副作用大,长期服药易损伤胃肠、血液系统和肝肾;现有膏剂的剂型落后,缺乏与制剂新技术如自热控温技术和超临界萃取技术的融合;膏剂药方较为单一,市场上的膏剂多为单味药或者单种成分提取物,药效欠佳。
目前,外治风湿病膏剂的剂型较为落后,仍以软膏剂、膏药、橡胶贴膏等剂型为主,凝胶剂、贴剂较少,且尚未发现CFDA已批准上市治疗风湿病的中药透皮贴剂。缺乏融合适宜的制剂新技术(如固体脂质纳米粒、环糊精包合物、脂质体等),新材料(如膜材料、裱衬材料、防黏材料等)将传统膏剂改制成中药缓控释、智能化、靶向制剂,用以改善传统膏剂的诸多不足。当前,促透技术研究的深度多停留在简单促透效果的考察,而未能结合中医药对促透机制、促透规律进行的探讨。将中医药与促透技术应用到中药外用膏剂中的研究,以增强其治疗风湿病的疗效的制剂匮乏。
因此,寻找一种能够治疗风湿性关节炎疼痛,疗效确切、药性稳定、不良反应率低的外用壮药组合物及其制剂,是目前重点的研究方向。
发明内容
为了解决现有技术中存在的上述技术问题,本发明提供一种治疗风湿性关节炎的外用壮药组合物及其制备方法与应用。具体是通过以下技术方案得以实现的:
一种治疗风湿性关节炎的外用壮药组合物,其特征在于,包括如下原料:藤杜仲、藤当归、宽筋藤、肿节风、海风藤、山霸王、鸡血藤、伸筋草、三钱三、大风艾、丢了棒、红鱼眼、半枫荷。
进一步的,所述各原料重量份数为:藤杜仲15-50份、藤当归50-100份、宽筋藤15-50份、肿节风15-50份、海风藤15-50份、山霸王15-50份、鸡血藤15-50份、伸筋草15-50份、三钱三15-50份、大风艾15-50份、丢了棒15-50份、红鱼眼15-50份、半枫荷15-50份。
进一步的,所述各原料重量份数为:藤杜仲40份、藤当归80份、宽筋藤40份、肿节风40份、海风藤40份、山霸王40份、鸡血藤40份、伸筋草40份、三钱三40份、大风艾40份、丢了棒40份、红鱼眼40份、半枫荷40份。
本申请的发明人对传统壮医药理论进行研究,在广西壮族民间医药的基础上,加以补充和整理,经过多年的深入了解和研究,挖掘并开发出一种治疗风湿性关节炎疼痛的外用壮药组合物。
壮族是历代健康长寿辈出的民族,其防病治病的方法丰富多彩,其中壮医敷贴疗法在壮族民间广泛使用,历史悠久,将壮药敷贴在人体患处和穴位上,通过药物刺激,调节人体阴阳平衡及天地人三气同步平衡,以达到防病治病的目的。在壮医基础理论中,发旺(风湿病)是由于邪毒(包括风毒、寒毒、湿毒、痧毒等)乘虚而入,邪毒在机体内阻滞三道两路,使三气不能同步而致病。“骆芡”“滚克”均属于壮医“发旺”(风湿病)范畴,“骆芡”缘于年老体虚,受伤留瘀,感受邪毒(风毒、寒毒、湿毒等),客于筋骨,阻滞龙路(Lohlongz)、火路(Lohfeiz),使天地人三气不能同步而致病。相当于中医的骨痹,西医的骨关节炎。“滚克”多缘于患者身体虚弱,邪毒(风毒、湿毒、寒毒、痧毒等)乘虚而入,阻滞龙路(Lohlongz)、火路(Loh feiz),使天地人三气不能同步,风寒湿毒客于肢体关节,气血运行不畅而致病。以小关节疼痛、肿胀、晨僵为特点。相当于中医的尪痹,西医的类风湿关节炎
本申请的外用壮药组合物具有散寒毒,除湿毒,祛风毒之作用,适用于风寒湿毒所致骆芡(骨关节炎)、滚克(类风湿关节炎)等。症见:关节肢体疼痛、重着,冷痛,或有肿胀,痛处游走不定,局部畏寒,得寒痛剧,得热痛减,皮色不红,关节屈伸不利。
方中藤杜仲、藤当归性微温,味苦、涩,祛风通络,消肿痛;肿节风微温,味苦、辛,除湿毒、祛风毒、消肿痛;海风藤味辛、苦,微温,祛风湿,通经络,止痹痛;鸡血藤苦、甘,温,补血活血,通经活络;伸筋草性微苦、辛,温,祛风除湿,舒筋活络;三钱三、山霸王性辛、温,祛风除湿,散瘀定痛;大风艾性辛、苦、温,温中活血、法风除湿;丢了棒性辛、微苦、平,祛风除湿,消肿止痛;红鱼眼性平、味微涩,祛风活血、散瘀消肿;半枫荷性温、味甘,祛风湿、舒筋活血。
本申请所述的中药组合物,对类风湿关节炎、骨关节炎具有抑制炎症、减轻关节肿胀、缓解关节疼痛等作用,可以用于作为或制备治疗类风湿关节炎或治疗骨关节炎药物药物方面,也可以用于作为或制备减轻关节肿胀、缓解关节疼痛、抗炎的药物方面。
并且本申请的中药组合物,还可以制备成外用膏剂。进一步的,所述外用膏剂,具体是透皮贴剂。壮医敷贴疗法在壮族民间广泛使用,历史悠久,将壮药敷贴在人体患处和穴位上,通过药物刺激,调节人体阴阳平衡及天地人三气同步平衡,以达到防病治病的目的。
藤杜仲,为夹竹桃科植物杜仲藤Parabarium micranthum(A.DC.)Pierre或毛杜仲藤Parabarium huaitingii Chun et Tsiang的干燥茎或根。秋后采收。毛杜仲藤皮含生物碱、酚类、有机酸、糖类。性味:性微温,味苦、涩。【药理研究】具降压作用、利尿、改善头晕以及抗衰老等作用,与人体内分泌系统、免疫功能系统、生长发育系统的结构和功能有密切关系【功能主治】宽筋活血,消肿,强壮补腰。小儿麻痹,风湿骨痛,跌打驳骨。
肿节风,为金粟兰科植物草珊瑚Sarcandra glabra(Thunb.)Nakai的干燥全株。化学成分:含挥发油、酯类、酚类、鞣质、黄酮、氰甙、香豆素、内酯:性味:性微温,味苦、辛。【药理研究】具抗菌、抗肿瘤、促进骨折愈合及抗病毒作用:浸膏及其总黄酮对动物的细胞吞噬作用有促进作用;对非特异性炎症,特别是胃溃疡有明显的促进胃细胞黏膜保护层修复的作用:促进食欲。【功能主治】抗菌消炎,祛风通络,活血散结。用于肺炎、阑尾炎、蜂窝组织炎、风湿痹痛、跌扑损伤、肿瘤。
藤当归,为紫金牛科植物当归藤EmbeliaparvifloraWall的干燥地上部分。性味:性温,味苦涩。【药理研究】具抗炎、抗氧化、细胞调节作用以及抗氧化功能。【功能主治】活血散瘀,补肾强腰。治月经不调,闭经,贫血,跌打损伤,骨折。
宽筋藤,为防己科植物宽筋藤Tinusporasinensi:(Iour.)Merr.的干燥藤茎。全年均可采收,除去老茎及叶,切段或趁鲜切厚片,晒干。以条匀、质嫩、色黄绿者为佳。性味:微苦,凉。【药理研究】具抗糖尿病活性、抗结核活性和抗菌活性等作用。【功能与主治】祛风止痛,舒筋活络。用于风湿痹痛,坐骨神经痛,腰肌劳损,跌扑损伤。
海风藤,为胡椒科植物风藤Piperkadsura(Choisy)Ohwi的干燥藤茎。性味:辛、苦,微温。【药理研究】海风藤能增加小鼠心肌营养血流量,降低狗心肌缺血区侧枝血管阻力,对冠心病和脑血栓有较好的疗效。海风藤提取物可以拮抗大鼠静脉注射内毒素引起的动脉血压下降,并能减轻内毒素血症对肺血管壁通透性增高引起的肺水肿。【功能与主治】祛风湿,通经络,止痹痛。用于风寒湿痹,肢节疼痛,筋脉拘挛,屈伸不利。
鸡血藤,为豆科植物密花豆(大血藤、血风藤、三叶鸡血藤、九层风)SpatholobussuberectusDunn的干燥藤茎。秋、冬二季采收,除去枝叶,切片,晒干。性味:苦、甘,温。【药理研究】具有抑制心脏和降低血压作用、抗癌作用、对脂质代谢的调节作用。【功能与主治】补血,活血,通络。用于月经不调,血虚萎黄,麻木瘫痪,风湿痹痛。
山霸王,为海桐花科海桐花属植物聚花海桐Pittosporumbalansae DC.(PittosporumconfertumMerr.etChun)的根及叶。主治:淋巴结结核,跌打肿痛,蛇咬伤,肿瘤。
伸筋草,石松科植物石松LycopodiumjaponicumThunb.的干燥全草。夏、秋二季茎叶茂盛时采收,除去杂质,晒干。性味:微苦、辛,温。【药理研究】石松水浸剂对由皮下注射枯草浸剂引起发热之家兔有降温作用;其有效成分为石松碱及棒石松碱、棒石松毒,后两者毒性较石松碱为弱。石松碱适当剂量能升高麻醉猫血压。对蛙心收缩力有增强作用。对兔、大鼠及豚鼠子宫有兴奋作用。对兔静脉注射30~50毫克/公斤有降温作用。对兔血糖、瞳孔、末梢红细胞数皆无影响。【功能与主治】祛风除湿,舒筋活络。用于关节酸痛,屈伸不利。
三钱三,为杜鹃花科植物羊踯躅RhododendronmolleG.Don的干燥花。性味:辛,温。【药理研究】具镇痛、杀虫以及对心血管系统影响本品有毒成分为梫木毒素,杜鹃花素和石楠素。中毒症状:开始恶心呕吐,腹泻,心跳缓慢,血压下降,动作失调,呼吸困难,严重者因呼吸停止而死亡。【功能与主治】祛风除湿,散瘀定痛。用于风湿痹痛,偏正头痛,跌扑肿痛,顽癣。
大风艾,本品为菊科植物艾纳香Blumeabalsamifera(L。)DC。的干燥地上部分。夏、秋季采收,阴于。性味:辛、苦,温。【药理研究】大风艾的提取液有扩张血管,降低血压的作用,临床上可用于失眠症和高血压病。大风艾浸剂的利尿作用,与咖啡因及茶叶浸剂相似,但较后者为弱。【功能与主治】温中活血,调经,法风除湿,茶虫。用于外感风寒,泻痢,腹痛肠鸣,肿账,月经不调,痛经,筋骨疼痛,跌打损伤,湿疹,皮炎,裤疮。
丢了棒,大戟科白桐树属植物白桐树Claoxylonpolot(Burm.)Merr.[C.indicum(Reinew.exBlume)Hassk.],以根及叶入药。性味:辛、微苦,平。有毒。【药理研究】具治疗全身麻痹和面神经疼痛作用。其毒性为叶有毒;误食后恶心、心中不适、全身无力、巩膜及皮肤微黄,严重者尿急,且茶褐色,并有腰痛、食欲消失、呕吐。【功能与主治】祛风除湿,消肿止痛。根:用于风湿性关节炎,腰腿痛,跌打肿痛,脚气水肿。叶:外用治烧烫伤。
红鱼眼,大戟科植物无毛龙眼睛PhyllanthusreticulatusPoir.var.glaberMuell.-Age.的茎。性味:性平,味微涩。有小毒。【药理研究】具抗菌、抗肿瘤、降血糖等作用。【功能与主治】祛风活血、散瘀消肿。属活血化瘀药下属分类的活血止痛药。
半枫荷,为梧桐科植物翻白叶树Pterospermumheterophyllum Hance的干燥根。全年可采,挖取根部,洗净,切片、段,晒干。主产于广东、广西、福建、台湾。性味:味甘,性温。功效:祛风湿、舒筋活血。主治:用于风湿性关节炎,类风湿关节炎,腰肌劳损,慢性腰腿痛,半身不遂,跌打损伤,扭挫伤;外用治刀上出血。
与现有技术相比,本发明创造的技术效果体现在:
本申请的中药组合物组方中藤杜仲、藤当归性微温,味苦、涩,祛风通络,消肿痛;肿节风微温,味苦、辛,除湿毒、祛风毒、消肿痛;海风藤味辛、苦,微温,祛风湿,通经络,止痹痛;鸡血藤苦、甘,温,补血活血,通经活络;伸筋草性微苦、辛,温,祛风除湿,舒筋活络;三钱三、山霸王性辛、温,祛风除湿,散瘀定痛;大风艾性辛、苦、温,温中活血、法风除湿;丢了棒性辛、微苦、平,祛风除湿,消肿止痛;红鱼眼性平、味微涩,祛风活血、散瘀消肿;半枫荷性温、味甘,祛风湿、舒筋活血。具有散寒毒,除湿毒,祛风毒之作用,适用于风寒湿毒所致骆芡(骨关节炎)、滚克(类风湿关节炎)等。症见:关节肢体疼痛、重着,冷痛,或有肿胀,痛处游走不定,局部畏寒,得寒痛剧,得热痛减,皮色不红,关节屈伸不利。
具体实施方式
下面结合具体的实施方式来对本发明的技术方案做进一步的限定,但要求保护的范围不仅局限于所作的描述。
实施例1
中药组合物,具体由如下成分组成:藤杜仲400g、藤当归800g、宽筋藤400g、肿节风400g、海风藤400g、山霸王400g、鸡血藤400g、伸筋草400g、三钱三400g、大风艾400g、丢了棒400g、红鱼眼400g、半枫荷400g。
实施例2
中药组合物,具体由如下成分组成:藤杜仲150g、藤当归1000g、宽筋藤150g、肿节风150g、海风藤150g、山霸王150g、鸡血藤150g、伸筋草150g、三钱三150g、大风艾150g、丢了棒150g、红鱼眼150g、半枫荷150g。
实施例3
中药组合物,具体由如下成分组成:藤杜仲500g、藤当归500g、宽筋藤500g、肿节风500g、海风藤500g、山霸王500g、鸡血藤500g、伸筋草500g、三钱三500g、大风艾500g、丢了棒500g、红鱼眼500g、半枫荷500g。
将各实施例所述组合物药材粉碎,粉碎的药材100目过筛,加入一定比例的生姜汁、蜂蜜进行调和,用黄酒作辅料,和成药团,压制成药饼状,裁剪成适当规格置于敷贴上,制成药膏。将药材粉碎、过筛。粉碎的药材100目过筛,根据药方,往药粉中加入一定比例的生姜汁、蜂蜜进行调和,用黄酒或醋作辅料。将姜汁蜂蜜混合物倒入药粉中和成药团。压制药膏成药饼状,裁剪成适当规格置于敷贴上。
运用自热控温技术,自热贴内含铁粉、活性炭,通过活性炭和铁粉等粉末与氧气接触后发生氧化反应而释放热量实现自动加热,在此基础上使用三级控温贴(背衬层、药膏层和隔离膜);采用超临界低温萃取提纯壮族道地药材,有效防止热敏性物质氧化、逸散,工艺简单易掌握且萃取速度快。
将所得药膏制成自热壮药敷贴。该自热壮药敷贴包括自热贴、背衬层、药膏层、隔离膜,所述药膏层涂覆在背衬层上,药膏层另一面覆盖有隔离膜,自热贴通过不干胶粘贴在背衬层上部,所述自热贴上设有多个单格,单格呈矩形阵列排布,单格内填充有自热材料,所述单格之间以及背衬层上部均设有导向条,导向条沿横向和纵向分布。该自热壮药敷贴发热温度预计控制在人体安全温度范围40-45℃,在敷贴治疗时限内(2-4h)不会引起低温烫伤,同时又可以最大限度的保证药物治疗效果。
选择用实施例1的药膏制备得到的敷贴进行下实验。
临床研究
(一)一般资料
120例类风湿关节炎患者采用随机数表法分为治疗组和对照组各60例。治疗组男性14例,女性46例;年龄25~77岁,平均年龄(53.42±8.91)岁;病程12~153个月,平均病程(68.33±37.82)月。对照组男性13例,女性47例;年龄16~77岁,平均年龄(52.13±13.42)岁;病程4~168个月,平均病程(71.33±45.31)个月。两组一般资料比较,差异无统计学意义(P>0.05),具有可比性。120例膝骨关节炎患者采用随机数表法分为治疗组和对照组各60例。治疗组男性22例,女性38例;年龄38~76岁,平均年龄(53.85±11.49)岁;病程23~110个月,平均病程(53.95±17.45)月。对照组男性23例,女性37例;年龄38~78岁,平均年龄(57.03±9.50)岁;病程12~115个月,平均病程(58.90±24.21)个月。两组一般资料比较,差异无统计学意义(P>0.05),具有可比性。患者均签署知情同意书。
(二)诊断标准
类风湿关节炎西医诊断标准按照2009年美国风湿病学会/欧洲抗风湿联盟(ACR/EULAR)制定的RA分类标准,评分6分或以上诊断RA。壮医辨证标准依据《壮医病证诊疗规范》中滚克疾病诊断。
骨关节炎参照美国风湿病学会膝骨关节炎分类标准(1986年)诊断。骆芡(膝骨关节炎)阴证的壮医诊断标准:参照2013年国家中医药管理局《7个民族41个病种民族医诊疗方案》:主症:膝关节疼痛、甚或肿胀,动则痛甚,屈伸不利,重则关节变形,病情迁延,反复不愈,皮肤不红,触之不热。兼症:膝关节痠软,乏力,发僵,麻木。目诊:“勒答”上龙路脉弯曲、延伸、有瘀点。多见于中老年人,起病隐匿、发病缓慢。X线摄片检查:骨质疏松,关节面不规则,关节间隙狭窄,软骨下骨质硬化,以及边缘唇样改变,骨赘形成。ESR、CRP可轻度增高。
(三)纳入标准
RA纳入标准①符合RA西医诊断标准,壮医辨证属阳证;②DAS评分>3.2分;③年龄18~70岁。
OA纳入标准①符合西医膝骨关节炎的分类标准,同时符合壮医骆芡(阴证)诊断标准;②轻、中度膝骨关节炎患者(关节功能Ⅳ级及以下、放射学分级Ⅳ级及以下);③年龄为38-60岁,性别不限。
(四)排除标准
RA排除标准①合并严重心脑血管疾病;②合并有活动性结核、肝炎或肿瘤等;③精神病、老年 痴呆,不能配合;④重叠其他风湿免疫疾病;⑤经研究者判断不能纳入者。
OA排除标准①年龄在38岁以下或60岁以上者;②妊娠或哺乳期妇女,过敏体质者;③合并严重心、脑血管、肝肾、呼吸及血液系统疾病者;④晚期重度骨关节炎(关节功能Ⅳ级、放射学分级Ⅳ级)患者;⑤未按规定完成治疗,无法判断或数据不全等影响疗效和安全性判断。
(五)治疗方法
RA治疗方法对照组按《2018中国类风湿关节炎诊疗指南》,口服甲氨蝶呤片(上海上药信谊药厂有限公司),10mg/次,1次/周;双氯芬酸钠双释放肠溶胶囊(TemmlerIrelandLtd.),10mg/次,1次/d。治疗组在对照组基础上予壮药自热敷贴治疗,每日1次,疗程2周。
OA治疗方法对照组口服双醋瑞因胶囊(批准文号:国药准字J20100150,规格:50mg/粒,TRB Pharma S.A生产)服用方法:50mg/次,饭后服,每日1次。治疗组在对照组基础上予壮药自热敷贴治疗,每日1次,疗程2周。疗程:持续服用2周。
(六)观察指标
RA观察指标①症状体征:晨僵时间、压痛关节数、肿胀关节数、CRP、ESR,于治疗前后各检验1次。
OA观察指标关节肿胀积分,于治疗前后各检验1次。
(七)统计学方法
采用SPSS20.0软件分析处理数据,计量资料以均数±标准差表示,行t检验;计数资料用百分率(%)表示,行x2检验。P<0.05表示差异有统计学意义。
(八)结果
RA患者两组治疗后,治疗组关节数、肿胀关节数、晨僵时间较对照组明显好转,差异均具有统计学意义(P<0.05),表明壮药自热敷贴治疗类风湿关节炎具有减轻关节肿胀、缓解关节疼痛、改善关节晨僵作用。见表1。两组治疗后CRP、ESR、均下降,且治疗组下降更明显,两组比较差异有统计学意义(P<0.05),表明壮药自热敷贴治疗类风湿关节炎具有抑制炎症作用。见表2。
OA患者两组治疗后,治疗组关节肿痛积分较对照组明显下降,差异均具有统计学意义(P<0.05),表明壮药自热敷贴治疗骨关节炎具有减轻关节肿胀、缓解关节疼痛作用,见表3。
表1RA患者2组症状及体征比较
注:治疗后与治疗前比较,△p<0.05;治疗组与对照组比较,*p<0.05
表2RA患者2组炎症指标比较
注:治疗后与治疗前比较,△p<0.05;治疗组与对照组比较,*p<0.05
表3OA患者2组关节肿痛积分比较
组别 | 例数 | 治疗前 | 治疗后 |
对照组 | 60 | 7.87±0.39 | 4.22±0.96△ |
治疗组 | 60 | 7.92±0.49 | 3.37±0.88△* |
注:治疗后与治疗前比较,△p<0.05;治疗组与对照组比较,*p<0.05
本研究中,壮药自热敷贴能减轻关节肿胀和疼痛,改善RA患者关节晨僵,降低CRP、ESR等疾病活动性指标,以及缓解OA患者关节肿痛症状,显示其治疗关节炎具有消肿止痛作用,能降低疾病活动度。
动物实验
(一)壮药自热敷贴对大鼠佐剂性关节炎的影响
1大鼠佐剂性关节炎模型的制备
雄性大鼠适应性饲养3d后,光照测痛仪以足移法筛选出痛阈值合格的大鼠,随机取10只大鼠为正常组,大鼠右后足常规消毒,正常组大鼠右后足趾皮下注射生理盐水0.1ml.,其余大鼠以Freund,s完全佐剂0.1ml注射于大鼠右后足跖皮下。测量致炎第8天右后足肿胀度、对四足的关节炎评分,以左后足关节活动受限、关节炎总评分3分以上为造模成功标准。右后足肿胀度=右后足踝关节周长-左后足踝关节周长。关节炎评分标准:根据关节炎发病大鼠关节红肿程度和范围以及关节肿胀变形情况,按0~4级进行评分;0分,正常;1分,踝关节有红斑及轻微肿胀;2分,踝关节至掌关节有红斑及轻微肿胀;3分,踝关节至趾关节有红斑及轻微肿胀或至掌关节有红斑及中度肿胀;4分,踝关节至趾关节有红斑及重度肿胀;每只足单独评分,将四肢评分相加作为关节炎评分,每只大鼠最高16分。
2分组与给药
将造模成功的佐剂性关节炎大鼠按关节炎综合评分分值随机分为模型对照组,万通筋骨组,普通无药自热贴组,壮药自热贴组,每组10只。大鼠于造模第8天开始给予万通筋骨贴、普通无药自热敷贴和壮药自热敷贴治疗,并用胶布固定,4h后取下敷贴,1次/d,每周6次,30天为1个疗程。按时间要求测量各项指标,计算各组均数方差,进行组间t检验。
3检测指标
痛阈值:敷贴前、敷贴第30天测痛阈值。
足肿胀度:敷贴前、敷贴第30天测量各组大鼠致炎足(右后足)和致炎对侧足(左后足)踝关节周长,计算足肿胀度。
关节炎评分:敷贴前、敷贴第30天进行关节炎评分。
血清指标:实验结束后,处死动物,腹主动脉取血,取血清Elisa法测免疫球蛋白G(IgG)、免疫球蛋白M(IgM)、肿瘤坏死因子α(TNF-α)及白介素1β(IL-1β)。
4壮药自热贴对大鼠迟发型超敏反应的影响
4.1实验动物分组
取KM小鼠50只,雄性,适应性饲养3d后,随机分为5组,分别为正常对照组,模型对照组,地塞米松组,普通无药自热敷贴组,壮药自热敷贴组,每组10只。壮药自热敷贴组和普通无药自热敷贴组给予分别将相应敷贴用胶布固定,地塞米松组(0.6mg/Kg)小鼠按20ml/kg体重灌胃给予相应药物,正常对照组和模型对照组给予相应体积蒸馏水,每天1次,连续给药7天。治疗前1天,将各组小鼠腹部脱毛,面积约3.0cm2,除正常对照组外,于腹部去毛处均匀涂抹0.5%的2,4-二硝基氯苯(DNCB)40μl/只致敏,治疗第3天强化1次。末次治疗1小时后,将0.2%DNCB20ul/只均匀涂于小鼠右耳激发,左耳涂抹丙酮橄榄油。在激发后24h,颈椎脱臼处死小鼠,剪下双耳、对齐、8mm打孔器取耳片,分别称量左、右耳片重量,另摘取各鼠免疫器官胸腺、脾脏,称重,计算各组均数方差,进行组间t检验。
4.2检测指标
动物体重:分别称量小鼠给药前与给药后的体重,并计算占初始体重比,占初始体重比(%)=(解剖时体重/初始体重)×100%。
脏器指数:脏器指数(%)=(脏器质量/体质量)×100%计算。(3)迟发型超敏反应强度:反应强度=右耳耳片重-左耳耳片重。
5壮药自热敷贴对醋酸致小鼠疼痛的镇痛作用
取小鼠40只,雌雄各半,随机分为模型对照组,阿司匹林组,普通无药自热敷贴组及壮药自热敷贴组,每组10只。普通无药自热敷贴组和壮药自热敷贴组给予自热贴治疗,并用胶布固定。阿司匹林组(0.2g/Kg)灌胃给药,正常对照组给予相应体积蒸馏水,容量20ml/kg,每日1次,连续3天末次给药1h后,每只小鼠按10ml/kg体质量腹腔注射0.6%醋酸溶液,立即观察、记录第一次扭体时间及15min内小鼠扭体反应次数,以第一次扭体时间、扭体次数作为痛反应指标,计算各组均数方差,进行组间t检验,并计算各组抑制率。
抑制率%=(空白组扭体次数-给药组扭体次数)/空白组扭体次数×100%
6壮药自热敷贴对毛细血管通透性的影响
取雄性KM小鼠40只,随机分为模型对照组,阳性对照组,普通无药自热敷贴组和壮药自热敷贴组,每组10只。普通无药自热敷贴组和壮药自热敷贴组给予自热贴治疗,并用胶布固定,阳性对照组小鼠按20ml/kg体重灌胃给予相应药物,正常对照组给予相应体积蒸馏水,每天1次,连续给药7天。于末次给药l小时后,尾静脉注射l%伊文思蓝0.1ml,并同时腹腔注射0.6%醋酸0.2ml,20分钟后,拉颈椎处死动物,剪开腹腔。用5ml蒸馏水冲洗腹腔数次,用吸管吸取腹腔洗出液5~6ml,离心5分钟,酶标仪590nm处测定吸光度,计算各组均数方差,进行组间t检验。
(二)实验结果
1壮药自热敷贴对大鼠佐剂性关节炎的治疗作用
1.1壮药自热敷贴对大鼠佐剂性关节炎痛阈的影响
佐剂性关节炎大鼠痛阈明显降低,与正常对照组比较均有极显著性差异(p<0.05);壮药自热敷贴能显著提高佐剂性关节炎大鼠痛阈,(p<0.05)。结果表明,壮药自热敷贴对佐剂性关节炎所致疼痛具有治疗作用。结果见表1。
表1壮药自热敷贴组对大鼠佐剂性关节炎痛阈的影响
组别 | 例数 | 治疗前/Sec | 治疗后/Sec |
正常对照组 | 10 | 9.15±0.70 | 9.34±0.36 |
模型组 | 10 | 6.29±0.58△ | 5.68±0.36△ |
万通筋骨组 | 10 | 6.51±0.33 | 7.97±0.54* |
普通无药自热敷贴组 | 10 | 6.37±0.38 | 7.14±0.34* |
壮药自热敷贴组 | 10 | 6.64±0.51 | 8.22±0.33* |
注:模型组与正常对照组比较,△p<0.05;万通组、敷贴组与模型组比较,*p<0.05
1.2壮药自热敷贴组对大鼠佐剂性关节炎足肿胀的影响
佐剂性关节炎大鼠右后足肿胀度明显增高,与正常对照组比较均有显著性差异(p<0.05);壮药自热敷贴组能显著减少佐剂性关节炎大鼠足肿胀度(p<0.05)。结果表明,壮药自热敷贴组对佐剂性关节炎所致足肿胀具有治疗作用。结果见表2。
表2壮药自热敷贴组对大鼠佐剂性关节炎足肿胀度的影响
组别 | 例数 | 治疗前/mm | 治疗后/mm |
正常对照组 | 10 | 0.0±0.0 | 0.0±0.0 |
模型组 | 10 | 4.6±1.1△ | 6.25±1.0△ |
万通筋骨组 | 10 | 3.9±1.1 | 2.1±0.4* |
普通无药自热敷贴组 | 10 | 4.1±1.2 | 3.8±0.8* |
壮药自热敷贴组 | 10 | 4.9±1.3 | 1.6±0.3* |
注:模型与正常对照组比较,△p<0.05;万通组、敷贴组与模型组比较,*p<0.05
1.3壮药自热敷贴组对大鼠佐剂性关节炎的影响
壮药自热敷贴组能显著降低大鼠关节炎总评分(p<0.05)。结果表明,壮药自热敷贴组对关节炎具有治疗作用。结果见表3。
表3壮药自热敷贴组对大鼠佐剂性关节炎评分的影响
组别 | 例数 | 治疗前 | 治疗后 |
正常对照组 | 10 | 0.0±0.0 | 0.0±0.0 |
模型组 | 10 | 3.5±0.6△ | 4.6±0.9△ |
万通筋骨组 | 10 | 3.5±0.4 | 1.7±0.8* |
普通无药自热敷贴组 | 10 | 3.5±0.5 | 2.3±0.6* |
壮药自热敷贴组 | 10 | 3.6±0.5 | 1.6±0.5* |
注:模型与正常对照组比较,△p<0.05;万通组、敷贴组与模型组比较,*p<0.05
1.4壮药自热敷贴组对大鼠佐剂性关节炎生化指标的影响
佐剂性关节炎大鼠的免疫球蛋白IgG、IgM、肿瘤坏死因子α及白细胞介素1β含量明显升高,与正常对照组比较具有显著性差异(p<0.05);壮药自热敷贴组能显著降低关节炎大鼠的免疫球蛋白IgG、IgM、肿瘤坏死因子α及白细胞介素1β的含量(p<0.05)。结果表明,壮药自热敷贴组减少炎症因子及免疫球蛋白的生成,对关节炎具有治疗作用。结果见表4。
表4壮药自热敷贴组对大鼠佐剂性关节炎生化指标的影响
组别 | 例数 | IgG(mg/mL) | IgM(μg/mL) | TNF-α(pg/mL) | IL-1β(pg/mL) |
正常对照组 | 10 | 2.22±0.15 | 238.5±24.9 | 45.46±1.31 | 6.64±0.35 |
模型组 | 10 | 2.38±0.10△ | 269.7±20.5△ | 48.73±1.94△ | 7.22±0.24△ |
万通筋骨组 | 10 | 2.21±0.11* | 231.0±42.0* | 45.68±2.87* | 6.41±0.43* |
普通无药自热敷贴组 | 10 | 2.32±0.12 | 252.4±33.6 | 46.64±1.46* | 6.92±0.39 |
壮药自热敷贴组 | 10 | 2.23±0.10* | 226.5±21.5* | 45.91±0.95* | 6.64±0.47* |
注:模型与正常对照组比较,△p<0.05;万通组、敷贴组与模型组比较,*p<0.05
2壮药自热敷贴组对小鼠迟发型超敏反应的影响
迟发型超敏反应模型小鼠的体重比、胸腺系数及脾系数明显降低,升高反应强度,与正常对照组比较,均有显著性差异(p<0.05);壮药自热敷贴组可降低迟发型超敏反应的反应强度,抑制胸腺萎缩,升高胸腺脏器系数(p<0.05)。结果表明,壮药自热敷贴组能降低外源性过敏原所导致的迟发型超敏反应强度,抑制其胸腺萎缩,壮药自热敷贴具有抗过敏作用。结果见表5。
表5壮药自热敷贴组对迟发型超敏反应模型小鼠的影响
注:模型与正常对照组比较,△p<0.05;地塞米松组、敷贴组与模型组比较,*p<0.05
3壮药自热敷贴组对醋酸致小鼠疼痛的影响
壮药自热敷贴组能减少醋酸所致小鼠的疼痛扭体次数,延长疼痛所致的扭体开始时间(p<0.05)。结果表明,壮药自热敷贴具有镇痛作用。结果见表6。
表6壮药自热敷贴对醋酸致小鼠疼痛的影响
组别 | 例数 | 扭体时间sec | 扭体次数次 | 抑制率% |
模型对照组 | 10 | 169.9±73.9 | 17.6±3.4 | - |
阿司匹林组 | 10 | 234.1±42.6* | 10.1±2.8* | 48.5 |
普通无药自热敷贴组 | 10 | 212.4±47.6* | 14.3±3.0 | 54.8 |
壮药自热敷贴组 | 10 | 292.8±56.96* | 10.6±4.8* | 43.7 |
注:与正常对照组比较,*p<0.05
4壮药自热敷贴组对小鼠毛细血管通透性的影响
壮药自热敷贴组明显增加小鼠腹腔洗出液的伊文思蓝含量,(p<0.05)。结果表明,壮药自热敷贴组有提高毛细血管通透性的作用。结果见表7。
表7壮药自热敷贴组对毛细血管通透性的影响
注:与正常对照组比较,*p<0.05
(三)结论
综上,表明壮药自热敷贴组具有修复受损关节、抗炎、抗过敏、活血及镇痛作用,对用于风湿热邪或风寒湿邪滞久化热所致的关节疼痛、肿胀,屈伸不利等症状明显有治疗作用。
病案举例:
病例1:朱某,女,55岁,因右侧肢体酸胀、双膝疼痛3年余,双手僵硬2年余于2011年06月08日入院。患者3年前无明显诱因下出现双膝关节疼痛,无肿胀、灼热,活动及上下楼梯加重,休息后可缓解,无晨僵,遂至广西中医学院第一附属医院就诊,予刮痧及针灸治疗,关节疼痛消失,恢复如常。2年前出现双手关节僵硬,未系统治疗,后双侧拇指关节逐渐肿胀,活动受限,以右侧为甚。症见:舌质暗淡,苔薄白,脉细。右手第一指间关节中度肿胀、压痛(+),屈伸中度受限,右侧拇掌关节轻度肿胀,压痛(+),左手第一指间关节轻度肿胀、压痛(+),屈伸轻度受限。双手握和可。双肩关节压痛(+),无肿胀、灼热,外展、内收、前屈、后伸、内外旋转均受限,右侧尤甚。辅助检查:ESR:45mm/h。腹部彩超:1、脂肪肝2、左肾钙乳症3、右肾钙化。X线:颈椎退行性变。其它检查未见明显异常。诊断:壮医诊断:骆芡、西医诊断:骨关节炎。使用本壮药自热敷贴后各关节无明显肿胀,压痛,酸胀缓解。
病例2:韦某,女,46岁,因反复双膝关节疼痛半年余,加重1周于2011年07月01日入院。患者于2010年12月份无明显诱因下出现双膝关节疼痛,无红肿、灼热,活动后加重,休息减轻,上下楼、下蹲困难,无晨僵,自行擦药酒,未见缓解,未系统治疗。7天前双膝关节疼痛加重,不能下蹲。症见:舌质暗红,苔白厚,脉弦,“勒答”上白睛浅淡,龙脉脉络有瘀点,五诊合参,双膝关节疼痛,活动后加重,下蹲困难。辅助检查:尿常规:BIL(3+),BLD(3+),PRO(2+),LEU(1+);ESR:72mm/h,肝功能:ALT:53U/L,血尿酸:345umol/L,血四脂:HDL-C:1.28mmol/L,双膝关节彩超:双膝关节积液;双膝正侧位片双侧髌骨骨质增生。诊断:壮医诊断:骆芡、西医诊断:双膝骨关节炎(急性期)。使用本壮药自热敷贴后双膝活动后稍疼痛,无肿胀、灼热。
病例3:施某,男,65岁,因反复左膝关节疼痛肿胀1年于2011年4月13日入院。患者于2010年4月下旬无明显诱因下出现左膝关节疼痛、肿胀行走时疼痛加重,休息后疼痛可缓解,就医后,左膝关节肿痛缓解不明显,此后左膝关节肿痛反复发作。症见:舌质红,苔黄厚,脉弦,“勒答”上白睛浅淡,龙脉脉络有瘀点。右膝关节轻度肿胀、灼热,中度内侧压痛,左膝关节中度肿胀、灼热、内侧压痛,双膝关节轻度外翻畸形,轻度“O”型腿,双膝骨擦感(+),骨响音(+),双侧“4”字征(+)辅助检查:入院辅查:血常规:WBC6.1×109/L,RBC5.34×1012/L,HGB142g/L,PLT239×109/L。尿常规:PH5.0,IBIL14.5umol/L,FBS5.81mmol/L,RF15IU/ml,ESR:10mm/h,CRP 1998.00ug/L,左侧膝关节液暗区(积液)。诊断:壮医诊断:骆芡、西医诊断:左膝骨关节炎(活动期)。使用本壮药自热敷贴后双膝稍微肿痛,活动较前明显好转。
病例4:陆某,女,65岁,因反复双膝疼痛10余年,加重半年于2013年08月26日入院。患者自诉10余年前无明显诱因下出现双膝疼痛,活动后加重,休息后可缓解,症状反复发作,未予诊治。约半年前始,双膝疼痛加重,走路时加重,屈伸不利,下楼困难,下蹲困难,未诊治,疼痛持续不缓解,半月前就医,诊断为骨关节炎,治疗后无明显好转。辅助检查:血沉:44mm/H。CRP5.4mg/L,。尿酸:370umol/L。血脂:CHOl5.70mmol/L,HDL-C2.07mmol/L。X线:提示C4/5、C5/6椎间盘病变;颈椎骨质增生。症见:舌质暗红,苔薄白,脉弦细,目诊见“勒答”上白睛浅淡,白睛龙脉脉络弯曲,双膝疼痛,屈伸不利,下蹲困难,下楼困难。诊断:壮医诊断:骆芡、西医诊断:双膝骨关节炎。使用本壮药自热敷贴后双膝无明显肿胀、灼热、压痛。
病例5:杨某,女,49岁,因全身酸累疼痛10余年,咳嗽、咳痰1周于2013年09月04日入院。患者自诉10余年前无明显诱因下出现全身酸累不适,颈、腰、双膝、双腕、双踝疼痛,呈酸痛,双腕、双踝、双膝疼痛明显时伴肿胀,无放射痛、牵扯痛,有时伴双手麻木,有时伴有头晕,休息后可缓解,久行、久立、上下楼时双膝疼痛加重,症状反复发作,未予诊治。1周前受凉后出现咳嗽、咳黄痰,无发热、畏寒、寒战、胸痛,于当地门诊治疗3天未好转,具体诊治疗不详。症见:舌质暗红,苔薄白,脉弦细,全身酸累,颈、腰、双膝疼痛。诊断:壮医诊断:发旺,西医诊断:双膝骨关节炎。使用本壮药自热敷贴后颈、腰、双膝疼痛明显缓解。
病例6:林某,女,58岁,因四肢多关节对称性肿痛1年余于2013年08月19日入院。患者于2010年年底始无明显诱因下出现双膝关节肿胀、疼痛、冷痛,上下楼困难,自以为是痛风,自服别嘌醇片治疗约8月,未有好转,改服“强的松”片治疗,肿痛症状缓解,但停药后复发加重,且波及双髋、双手、双腕、双肘、双肩、双踝关节。一直服用强的松片治疗。2013年初,出现双手麻木、肿胀、冷痛,遇冷或热刺激则疼痛加重,双手活动不利,3月底,至广西民族医院查RF54.8IU/ml,查双手X线示:双手掌指关节普遍骨质疏松。症见:舌质暗淡,苔白,脉弦细,双手、双腕、双肘、双肩、双踝、双膝关节肿痛、活动不利,双手麻木,颈肩酸累。诊断:壮医诊断:滚克,西医诊断:类风湿关节炎、骨关节炎、重度骨质疏松症。使用本壮药自热敷贴后患者病情较前明显好转,双膝无明显肿胀,压痛(-)。使用本药后双手、双腕、双肘、双肩、双踝、双膝关节肿痛症状缓解。
病例7:韦某,男,52岁,因四肢多关节对称性肿痛5年余,加重1周于2013年08月28日入院。患者于5年前无明显诱因下出现右腕肿痛,约半年后波及左腕,又数月后波及双踝、双、双膝、双手、双肩、双肘、双髋肿痛,伴晨僵超过1小时,肿痛甚时伴有低热,未测体温。曾至市人民医院就诊,诊断为:“类风湿关节炎”,予“风湿骨痛”等药物治疗,服药后肿痛可稍缓解,停药后加重。3年前始至当地某医院,予口服不明成份药丸治疗,服药后肿痛缓解,停药后加重,且出现颜面变肥胖。2月前自服“瑶山寨土药王”,肿痛稍缓解,停药后加重。约1周前始各关节肿痛加重,尤以右肩、右肘、右腕、右手手关节明显,并出现右前臂近肘关节处局部硬肿、灼热明确。症见:舌质暗红,苔黄厚,脉弦细,双手、双腕、右肘、双肩、双踝、双膝关节肿痛、活动不利,右前臂近肘关节处局部硬肿、灼热。诊断:壮医诊断:滚克,西医诊断:类风湿关节炎(、双膝骨关节炎。使用本壮药自热敷贴后双手、双腕、右肘、双肩、双踝、双膝关节肿痛明显缓解,无灼热。
病例8:梁某,女,40岁,因反复四肢多关节对称性肿痛2年于2014年06月17日入院。患者于2007年10月份无明显诱因出现左踝关节疼痛,轻度肿胀,灼热,自行口服药物及涂擦药酒等治疗,症状可缓解。2008年2月份出现双膝关节疼痛,灼热,行走困难,到当地医院查RF、行双膝X线均未见异常,予中药、针灸等治疗,效果欠佳。之后关节肿痛波及右踝关节、双手近端指间关节、双手掌指关节、双腕关节、双肘关节、双肩关节,伴晨僵,持续约5小时,曾至陕西省红十字中医骨病治疗康复中心及当地多家医院就诊,查RF最高达20IU/ml,ESR90mm/h,诊断为“类风湿关节炎”,予抗炎、活血通络等治疗效果欠佳。症见:舌质淡红,苔薄白,脉细,双手近端指关节、双手掌指关节、双腕、双肘、双肩、双膝、双踝肿痛、活动受限,双膝下蹲时疼痛加重。诊断:壮医诊断:滚克阴证、西医诊断:类风湿关节炎-中晚期(活动期)、双膝骨关节炎。使用本壮药自热敷贴后患者诉双肩、双肘、双踝活动时有轻度疼痛,静止时无明显疼痛。
病例9:马某,女,64岁,因多关节疼痛13年,肿胀9月余,加重5天于2011年07月21日入院。患者于1998年7月无明显诱因下出现双肩及双大腿疼痛,不伴肿胀及发热,至当地卫生院就诊,诊断不详,予青霉素静滴后疼痛缓解不明显,仍反复发作,并逐渐波及双手、双腕、双膝关节。2001年至人民医院就诊,诊断“类风湿关节炎”,予中药物内服,出现腹部疼痛不适后停药。此后关节疼痛明显时自行至当地私人门诊予药物静滴及肌注,关节疼痛可缓解,停药后出现关节疼痛加重,并出现满月脸。2010年10月出现全身多关节疼痛加重,伴双手肿胀,至当地卫生院查RF(+),诊断“类风湿关节炎”,予药物治疗,关节肿痛缓解。2011年7月16日出现双手、双腕、双膝、双足肿痛复发,行走及下蹲困难。症见:舌质红,苔薄白,脉弦细,发热,双手、双腕、双膝、双足肿痛,屈伸不利,行走及下蹲困难,晨僵24小时。辅助检查:双手平片:双手未见骨及关节病变、RF:10IU/ml、ESR:78mm/H。诊断:壮医诊断:滚克(中晚期)-活动期阳证、西医诊断:类风湿关节炎、重度骨质疏松症。使用本壮药自热敷贴后患者全身关节疼痛较入院时减轻,活动较前明显好转。
最后,应当指出,以上实施例仅是本发明较有代表性的例子。显然,本发明的技术方案并不限于上述实施例,还可以有许多变形。本领域的普通技术人员能从本发明公开的内容直接导出或联想到的所有变形,均应认为是本发明的保护范围。
Claims (9)
1.一种治疗风湿性关节炎的外用壮药组合物,其特征在于,包括如下原料:藤杜仲、藤当归、宽筋藤、肿节风、海风藤、山霸王、鸡血藤、伸筋草、三钱三、大风艾、丢了棒、红鱼眼、半枫荷。
2.根据权利要求1所述的中药组合物,其特征在于,所述各原料重量份数为:藤杜仲15-50份、藤当归50-100份、宽筋藤15-50份、肿节风15-50份、海风藤15-50份、山霸王15-50份、鸡血藤15-50份、伸筋草15-50份、三钱三15-50份、大风艾15-50份、丢了棒15-50份、红鱼眼15-50份、半枫荷15-50份。
3.根据权利要求1所述的中药组合物,其特征在于,所述各原料重量份数为:藤杜仲40份、藤当归80份、宽筋藤40份、肿节风40份、海风藤40份、山霸王40份、鸡血藤40份、伸筋草40份、三钱三40份、大风艾40份、丢了棒40份、红鱼眼40份、半枫荷40份。
4.权利要求1所述的中药组合物,在作为或制备治疗类风湿关节炎药物方面的应用。
5.权利要求1所述的中药组合物,在作为或制备治疗骨关节炎药物方面的应用。
6.权利要求1所述的中药组合物,在作为或制备减轻关节肿胀、缓解关节疼痛的药物方面的应用。
7.权利要求1所述的中药组合物,在作为或制备抗炎药物方面的应用。
8.使用权利要求1所述的中药组合物制备得到的外用膏剂。
9.根据权利要求8所述的外用膏剂,其特征在于,所述外用膏剂,具体是透皮贴剂。
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