CN110742993A - 一种止痛消肿贴膏及其制备方法和应用 - Google Patents
一种止痛消肿贴膏及其制备方法和应用 Download PDFInfo
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- CN110742993A CN110742993A CN201911264548.6A CN201911264548A CN110742993A CN 110742993 A CN110742993 A CN 110742993A CN 201911264548 A CN201911264548 A CN 201911264548A CN 110742993 A CN110742993 A CN 110742993A
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- parts
- plaster
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- radix
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Abstract
本发明涉及外敷中药制剂领域,尤其涉及一种止痛消肿贴膏及其制备方法和应用。一种止痛消肿贴膏,所述贴膏由膏剂A和粉剂B混合而成,所述的膏剂A部分包括以下重量份原料药:防己20‑90份、桂枝20‑90份、独活20‑90份、细辛20‑90份、川乌20‑90份、草乌20‑90份、川椒20‑90份、制附子20‑90份、天南星20‑90份、姜黄20‑90份、桃仁20‑90份、当归20‑90份、乳香20‑90份、没药20‑90份;所述的粉剂B部分包括以下重量份原料药:白芥子6‑20份、土鳖虫6‑20份、三七6‑20份、乳香6‑20份、没药6‑20份、川椒6‑20份。用于治疗风湿性关节炎、骨质增生、滑膜炎、腰脱和各种关节疼痛肿胀,止痛消肿疗效好,操作简单,携带方便,无毒副作用,组方中药物的药效发挥的均衡,药物利用率高,治疗效果好。
Description
技术领域
本发明涉及外敷中药制剂领域,具体涉及治疗类风湿关节炎的中药贴膏,尤其涉及一种止痛消肿贴膏及其制备方法和应用。
背景技术
膏药外贴(以达到消肿止痛)的疗法历史悠久,早就见于晋代《肘后方》中,有“治疟疾寒多热少,或但寒不热,临发时,以醋和附子末涂背”。宋代《太平圣惠方》有“治疗腰脚风痹冷痛有风,川乌头三个去皮脐,为散,涂帛贴,须臾即止”。明代《普济方》有“鼻渊脑泻,生附子末,葱涎和如泥,罨涌泉穴”。明代李时珍的《本草纲目》有“以赤根捣烂,入元寸,贴于脐心,以帛束定,得小便利则肿消”,其他如《外台秘要》、《集简方》、《经验方》、《摘玄方》、《小品方》等书,都有关于外贴膏药疗法的记载。可见,外贴膏药是祖国医学中的一个组成部分。
类风湿性关节炎(RA)是一种以对称性、多关节炎为主要表现的慢性、全身性自身免疫性疾病。 目前尚无特异治疗,其发病率、致残率均较高,严重危害人类健康。关节局部的炎症诱导的骨质丢失、破坏是导致 RA患者关节变形,影响生活的关节环节, 同时由炎症引起的关节肿痛症状往往是患者就诊时最痛苦的主诉, 因此有针对性的改善关节肿痛、抑制炎症成为临床治疗的主要方向之一,也是目前风湿病临床医生与基础研究人员的研究重点。针对RA的抗炎止痛,目前西医仍以非甾体类抗炎药及激素为主导治疗。众所周知,长期服用非甾体类抗炎药和激素,RA患者消化道出血、心脑血管事件及股骨头坏死的发生率明显升高,使得患者不能长期坚持用药,甚至在急性期也无药可用。而中医中药的外治法,在此有着独特的优势,具有毒副作用少、费用低、起效快、适用范围广、直达病所、局部药物浓度高等优势,是效奇而安全的良好治疗途径。
目前RA的中药膏药外治法,已开展的如火如荼,如梁树旗用风寒湿灵散(生胆南星、赤芍、干姜、官桂、白芷)治疗 RA 140 例。 诸药做成散剂,用白酒适量调成糊状,敷于患处,并用塑料薄膜包严扎紧,每日 1 次,每次 2h , 10 次为 1 疗程,经 3 个疗程治疗总有效率 98.6% 。 李琴治疗 RA 60例,寒湿痹阻、疼痛较甚者用制川草乌、细辛、川芎、乳香、没药、白芷、花粉各 60g ,冰片 30g ;痰瘀互阻、僵硬为甚者用当归、川芎、桃仁、乳香、没药各 60g ,土鳖虫、全蝎、白芥子、胆南星、冰片各 30g ;风湿热痹、关节红肿热痛者用黄柏、大黄、乳香、没药、花粉各 60g ,青黛、蟾酥、白芷、冰片各 30g 。 药物用姜汁调和成糊状,敷贴于疼痛关节处,用穴位热疗器照射患处,每次 30min ,10d 为 1 疗程, 严重者可连续使用 2~3 个疗程。 结果示显效 48例,有效 12 例,全部有效。 曹炜等 用雷公藤、芒硝、炙乳香、炙没药、薄荷等加工成膏,外敷病变关节,单独外治湿热瘀阻型类风湿关节炎30例,治疗4周后显效率 43.3% 。焦娟以雷公藤为主药的中药复方外敷制剂配合内服中药汤剂,对62例活动期RA 湿热瘀阻证患者进行为期4周的随机对照单盲前瞻性研究,结果显示中医内治外敷法取得较好疗效,对关节局部症状、体征疗效确切, 均有明显改善作用, 达到ACR20 标准的病例为34.3% ,中医湿热瘀阻证候总有效率 75.8% ,且起效快,平均在 1周之内迅速减轻局部关节疼痛、 肿胀症状, 止痛及消肿起效时间,内外合治组均短于单纯内治组等等,综上所述,复方膏药外敷对各型RA的关节关节肿痛,都有很好的治疗效应。可见,复方中药膏外敷法在治疗RA关节肿痛中,为人们提供了良好的思路借鉴,为类风湿关节炎的治疗开阔了思路。有人预言21世纪的医学是理疗的世界 ,是自然疗法的世界。中医药在类风湿治疗方面有丰富的经验和教训,因此发掘中医学、中医药外治法在类风湿治疗方面的潜在优势,重视中药外治法,必然会更广阔的空间。
类风湿关节炎(Rheumatoid arthritis,RA)是一种以侵犯肢体关节为主的疾病,其发病率约占人口的0.35%,发病人群年龄较低,病程漫长,治疗效果不理想,致残率高,随着检测手段的进步,该病的确诊人数呈逐年上升趋势,发病人口逐渐增多,严重威胁着广大人民群众的健康,是临床常见病,多发病。
类风湿关节炎隶属祖国医学“痹证”范畴,认为发病是由于人体正气亏虚,复感受外邪侵袭或外伤,劳倦过度,导致风寒湿邪闭阻于内,流注于经络、关节,气血运行不畅,日久风寒湿邪与痰瘀互结而致筋骨经脉失养,周身关节疼痛,屈伸不利,重者关节肿大畸形。目前应用非甾体抗炎药、激素、免疫抑制剂以及生物制剂治疗本病,存在着费用高、疗效不满意、副作用大、疗程长的不足,临床医师和风湿病患者迫切需要采用疗效高、价格低廉、副作用小,能够明显减轻痛苦,快速控制病情的有效治疗方法。
现代医学研究表明:穴位给药的生物利用度明显高于一般给药,因腧穴对药物具有敏感性和放大效应,通过药物对皮肤的刺激引起皮肤和患部的血管扩张,促进局部和周身的血液循环,增强新陈代谢,改善局部组织营养,提高细胞免疫和体液免疫功能。改善机体的免疫状态,增强机体抗病能力。此外,穴位贴敷还可刺激皮肤的神经末梢感受器,通过神经系统形成新的反射,从而破坏原有的病理反射联系;药物的刺激在大脑皮层形成一个新的兴奋灶,遗留下痕迹反射,长期的抑制作用改变了下丘脑-垂体-肾上腺皮质轴的机能状态。
从现代透皮制剂给药方式看,膏药外治法有以下特点:1)不经消化系统的破坏和肝脏的分解;2)提供较长时间而稳定的药物作用时间;3)药物可随时停止进入体内;4)由于皮肤局部吸收,可以使血药浓度稳定。
现有技术治疗关节类疾病的中药贴膏,在组方中缺少得力成分,致使治病单一或治愈率低;同时组方中药物的药效不能尽快很好的发挥,或药效发挥的不均衡,治疗效果差。 同时现有中药贴膏在使用时,往往会对所贴皮肤引起刺激,使所贴皮肤上有过敏和痒的现象。使得患者在使用此膏药时很大可能无法坚持使用。现有的治疗方法都存在治疗时间长、治疗效果差的情况,对病人的身心都造成不好的影响,如今人们对于关节疾病的关注度也日益提高,研制治疗时间短、治疗效果好的药物也成为热点和亟需解决的问题。
发明内容
针对上述问题,本发明目的在于提供一种止痛消肿贴膏及其制备方法和应用,该外用中药贴膏止痛消肿疗效好,操作简单,携带方便,无毒副作用,组方中药物的药效发挥的均衡,药物利用率高,治疗效果好。
为了实现上述发明目的,本发明提供了以下技术方案。
一种止痛消肿贴膏,所述贴膏由膏剂A和粉剂B混合而成。
进一步地,所述的膏剂A部分包括以下重量份原料药:防己20-90份、桂枝20-90份、独活20-90份、细辛20-90份、川乌20-90份、草乌20-90份、川椒20-90份、制附子20-90份、天南星20-90份、姜黄20-90份、桃仁20-90份、当归20-90份、乳香20-90份、没药20-90份。
进一步地,所述的粉剂B部分包括以下重量份原料药:白芥子6-20份、土鳖虫6-20份、三七6-20份、乳香6-20份、没药6-20份、川椒6-20份。
进一步地,所述膏剂A部分按重量份数计还添加有下述原料药的一种或多种:生姜20-50份、绞股蓝20-50份、透骨草20-50份、荆芥20-50份、蚕沙20-50份、伸筋草20-50份、桑枝20-50份、丝瓜络20-50份、丹参20-50份、红花20-50份、桃仁20-50份、牛膝20-50份、鸡血藤20-50份、地龙20-50份、全蝎20-50份、续断20-50份。
进一步地,所述膏剂A部分按重量份数计还添加有下述原料药的一种或多种:远志18-35 份、钩藤18-35 份、僵蚕18-35 份、补骨脂18-35 份、海马18-35 份、沙苑子18-35份、当归18-35 份、生地黄18-35 份、白芍18-35 份、构祀子18-35 份、女贞子18-35 份、蛇床子18-35 份、木鳖子18-35 份、苍术18-35 份、泽泻18-35 份、车前子18-35 份、石韦18-35 份、草薛18-35 份、虎杖18-35 份、鹿茸18-35 份、甘草18-35 份、黄柏18-35 份、苦参18-35 份、白鲜皮18-35 份、陈皮18-35 份、积实18-35 份、乌药18-35 份、香附18-35 份。
进一步地,所述粉剂B部分按重量份数计还添加有下述原料药的一种或多种:全蝎10-35 份、娱蛤10-35 份、红花10-35 份、姜黄10-35 份、雪上一枝篙10-35 份、寻骨风10-35 份、草乌10-35 份、地龙10-35 份、甘草10-35 份、秦芜10-35 份、防风10-35 份、五加皮10-35 份、牛膝10-35 份、丝瓜络10-35 份、沙苑子10-35 份、鸡血藤10-35 份、僵蚕10-35份、川芍10-35份。
优选的,一种止痛消肿贴膏,所述贴膏由膏剂A和粉剂B混合而成,所述的膏剂A部分由以下重量份原料药制成:防己20份、桂枝20份、独活30份、细辛10份、川乌50份、草乌50份、川椒30份、制附子50份、天南星90份、姜黄60份、桃仁30份、当归40份、乳香20份、没药20份;所述的粉剂B部分由以下重量份原料药制成:白芥子10份、土鳖虫20份、三七6份、乳香6份、没药6份、川椒6份。
一种止痛消肿贴膏的制备方法,具体包括以下步骤。
步骤1、按处方中粉剂B部分的原料所需比例称取中药材,混合研细,过 40-120 目筛待用。
步骤2、按处方中膏剂A部分的原料所需比例称取中药材,将药加入2000ml水煎三次,前两次100℃水煎三小时过滤,第三次煎两小时过滤,合并三次滤液熬成流浸膏200ml备用。
步骤3、取医用压敏热溶胶500-1000g加热至 110-150 ℃时融化。
步骤4、将步骤1制得的药粉缓慢加入到步骤3制得的融化的热熔胶中,搅拌均匀。
步骤5、然后再加入步骤2制得的流浸膏和50-100ml氮酮,继续搅拌均匀得膏药。
进一步地,所述医用压敏热溶胶为黑胶、透明胶。
一种止痛消肿贴膏在制备治疗风湿性关节炎、骨质增生、滑膜炎、腰脱和各种关节疼痛肿胀的外用药物中的应用。
一种止痛消肿贴膏使用方法:将制备好的贴膏用于外贴于患处,1张/天, 2 天换1次。疗程 10 天为 1个疗程。
本发明中贴膏各原料的药效和药理作用如下。
防己:辛苦,温,入肾、脾、胃经。功能与主治:利水消肿,祛风止痛。用于水肿脚气、小便不利、风湿痹痛、湿疹疮毒、高血压症。现代药理防己具有镇痛、消炎,抗过敏的作用。
桂枝:辛,甘温,归心、肺、膀胱经,温经通脉,主治关节痹痛,《本草经疏》:"实表祛邪。主利肝肺气,头痛,风痹骨节挛痛。"现代药理桂枝具有镇痛作用,抗炎作用和对免疫系统的影响。
独活:辛散苦燥,气香温通,功善袪风湿,止痹痛,为治风湿痹痛主药,凡风寒湿邪所致之痹证,无论新久,均可应用;因其主入肾经,性善下行,尤以腰膝、腿足关节疼痛属下部寒湿者为宜。
细辛:细辛芳香气浓,性善走窜,功能祛风、散寒、止痛。细辛既散少阴肾经在里之寒邪以通阳散结,又搜筋骨间的风湿而蠲痹止痛。
川乌:辛、苦,热;有大毒。归心、肝、肾、脾经。功效:祛风除湿,温经止痛。用于风寒湿痹、关节疼痛、心腹冷痛、寒疝作痛。用于治疗风寒湿痹、关节疼痛等病症。生川乌外用可作为某些神经痛及风湿的镇痛剂。现代药理研究表明,川乌具有:抗炎作用:川乌总碱可显著抑制大鼠角叉菜胶、鲜蛋汤、组织胺以及5-羟色胺引起的足肿胀。扩血管、降压作用:川乌和乌头碱均可扩张血管,起一过性降压作用。川乌有镇痛、局麻作用:乌头碱系生物碱是其有效成分,上述作用均是中枢性的。
草乌:辛,热,有毒。入肝、脾、肺经。功用主治:搜风胜湿,散寒止痛,开痰,消肿。治风寒湿痹,中风瘫痪,破伤风,头风,脘腹冷痛,痰癖,气块,冷痢,喉痹,痈疽,疔疮,瘰疬。《药类法象》:治风痹血痹,半身不遂,行经药也。《纲目》:治头风喉痹,痈肿疔毒。主大风顽痹。《东医宝鉴》:治风湿麻痹疼痛,发破伤风汗。《纲目拾遗》:追风活血,取根入药酒。《贵州民间方药集》:治麻痹症。又为伤科用药。
川椒:辛、温。有小毒。入脾、胃、肾经。功效:温中,止痛,杀虫。功效特点:本品辛辣而温,善散阴冷之气,为健胃及解毒驱虫药,内服外用皆可。功效作用:散寒燥湿,蠲痹止痛。
制附子:辛、甘,大热;有毒。归心、肾、脾经。具有逐风寒湿邪之功效。《本经》:“主风寒咳逆邪气,温中,金疮,破癥坚积聚,血瘕,寒湿踒躄,拘挛膝痛,不能行步。”《别录》:"脚疼冷弱,腰脊风寒,心腹冷痛,霍乱转筋,下痢赤白,坚肌骨,强阴,又堕眙,为百药长。”
桃仁:桃仁性甘平、味苦,入肺、肝、大肠经;有破血行瘀,润燥滑肠的功效;治经闭、痛经、瘕瘕痞块,跌打损伤、肠燥便秘。桃仁的药理作用:祛瘀血作用:本品水煎醇沉液可使离体兔耳静脉血管流量增加,有舒张血管作用。给麻醉犬动脉注射,能增加股动脉血流量及降低血管阻力,对血管壁有直接扩张作用。本品还有抑制血液凝固和溶血作用。桃仁提取物50mg/ml,脾动脉内给药可使麻醉大鼠肝脏微循环内血流加速,并与剂量相关,提示对肝脏表面微循环有一定的改善作用。抗炎作用:本品在的蛋白成分中的两个均一蛋白成分,静脉注射给药,对二甲苯所致小鼠耳急性炎症反应,均有显著抑制作用。抗过敏作用。
乳香:辛苦,温。主治:调气活血,定痛,追毒。治气血凝滞、心腹疼痛,痈疮肿毒,跌打损伤,痛经,产后瘀血刺痛。《日华子本草》:止霍乱,心腹痛。煎膏止痛长肉。《纲目》:消痈疽诸毒,托里护心,活血定痛,伸筋,治妇人难产,折伤。
没药;苦,辛,平。治跌打损伤、金疮、筋骨、心腹诸痛、症瘕、经闭、痈疽肿痛、痔漏、目障。
土鳖虫:咸,寒;有小毒。归肝经,具有破瘀血,续筋骨之功效,本品咸寒入血,主入肝经,性善走窜,能活血消肿止痛,续筋接骨疗伤,为伤科常用药,尤多用于骨折筋伤,瘀血肿痛。
三七:温甘,苦,归肝,胃经,具有散瘀止血,消肿定痛之功效。《本草纲目》云:“三七止血,散血,定痛。”《玉揪药解》云:“三七和营止血,通脉行瘀,行瘀血而敛新血。”
当归:味甘而重,故专能补血,其气轻而辛,故又能行血,补中有动,行中有补;现代药理当归对免疫功能低下的机体有免疫调解和恢复作用。
白芥子:辛温,味厚气锐,入经络,搜剔痰结。《开宝本草》谓白芥子主“湿痹不仁、骨节疼痛等”。
南星:苦、辛、温,有毒,具有散风、祛痰、止痛,与白芥子均入经络,祛除经络中的痰浊。
姜黄:辛散苦燥温通,可外散风寒湿邪,内行气血,通经消肿止痛,尤长于行肢臂而除痹痛。
本发明中所述的止痛消肿贴膏是根据经络理论与贴敷等理论结合现代医学人体免疫学理论,总结数十年临床实践经验,采用中药膏剂外用贴敷手段,对类风湿关节炎进行治疗。本发明中药贴膏贴敷法的作用机理目前认为有两种途径。其一:经络的作用。病有从外入,有从内生,但都离不开经络之地面-十二皮部,而穴位又循序分布于十四经脉之上,药切皮肤穴位之上,药气速到经脉,摄于体内而达到病所,故贴敷用药,实本于针灸经络穴位治病之理,法虽异而其理则一。其二:膏药的作用。膏药,切近皮肤,彻于肉理,能将药之气味透过皮肤直到经脉摄于体内,融化于津液之中,具有内外一贯之妙,正如《理瀹骈文》所说的“切于皮肤,彻于肉理,摄于吸气,融于津液”。随其用药,能祛邪,拔毒气之外出,抑邪气以内消;能扶正,通营卫,调升降,理阴阳,安五脏,挫折五郁之气,而资化源。基于以上两点,膏药外用疗法可收到经络之效、药物之效的双重效应。
“风、寒、湿、痰、淤”乃是类风湿关节炎关节肿痛的主要机理,中医认为“痹”证的病因为风、寒、湿三邪相互交织而为病。 该病病程较长,久病入络成痰、成瘀,经络瘀阻则出现疼痛、关节功能障碍等症。而在治疗中,每每运用祛风、温经、除湿、化痰、活血之法,便能达到神效,要到病除。因此针对病因施以外治之法。本方中用防己、桂枝、独活等药,以驱风邪兼除湿邪,其意取《金匮》治风湿之法“若治风湿者,发其汗,但微微似欲出汗者,风湿俱去也”;以川乌、草乌、川椒、制附子、细辛等大辛热燥之药,逐其寒湿之邪并止痛;天南星、白芥子、姜黄化顽痰;同时用桃仁、乳香、没药、当归、土鳖虫、三七等药活血祛瘀通络,血行则风自灭,以助驱风之药的药力,瘀除则经络得以疏通“通则不痛”。本发明的中药贴膏方中诸药合用,组成了一剂祛风湿,止痹痛的良方。
与现有技术相比,本发明的有益效果。
1)本发明中药贴膏的制备方法改变药料的“油炸熬枯”的作法,在制备工艺实行药料的分类处理,提高了膏药中药物有效成分的含量,从而大大提高了药效。
2)本发明中药贴膏加入无任何副作用皮肤渗透剂,加强药物渗透,提高了膏药的疗效。
3)本发明中药贴膏根据药理作用和药物成分进行处方设计,使配方更具针对性,精炼、高效。
4)本发明中药贴膏采用脱敏贴,消除了贴膏引起的过敏反应。
5)本发明中药贴膏加入现代材料,使膏药常年保持适宜粘度,无须加温敷贴,揭下时不粘连皮肤,几乎不会对所贴皮肤引起刺激,所贴皮肤上不会有过敏和痒的现象。方便安全,患者乐于接受。
6)本发明中药贴膏最大限度地保留和发挥有效成分的作用。可以迅速将病痛缓解,减轻,改善,控制过程不让其发展,哪痛贴哪,直达患处,痛则不通,通者不痛。
7)本发明中药贴膏,根据中医药的配伍原则,将处方中中药进行组方,有效增强各成分的原有药效,使各成分相辅相成,产生良好的协同作用,对治疗各种关节疼痛肿胀有显著疗效,有潜在的社会效益。
8)本发明中药贴膏中配方所用的原料均来源于《中国药典》的道地药材,毒副作用小,可长期使用。
具体实施方式
下面结合具体实施例进一步详细说明本发明。对本发明的技术方案作进一步的描述,但本发明并不限于这些实施例。
实施例1 一种止痛消肿贴膏的制备方法。
一种止痛消肿贴膏,所述贴膏由膏剂A和粉剂B混合而成,所述的膏剂A部分包括以下重量份原料药:防己20份、桂枝20份、独活30份、细辛10份、川乌50份、草乌50份、川椒30份、制附子50份、天南星90份、姜黄60份、桃仁30份、当归40份、乳香20份、没药20份;以及按重量份数计还添加有下述原料药的一种或多种:生姜20-50份、绞股蓝20-50份、透骨草20-50份、荆芥20-50份、蚕沙20-50份、伸筋草20-50份、桑枝20-50份、丝瓜络20-50份、丹参20-50份、红花20-50份、桃仁20-50份、牛膝20-50份、鸡血藤20-50份、地龙20-50份、全蝎20-50份、续断20-50份;以及按重量份数计还添加有下述原料药的一种或多种:远志18-35份、钩藤18-35份、僵蚕18-35份、补骨脂18-35份、海马18-35份、沙苑子18-35份、当归18-35份、生地黄18-35份、白芍18-35份、构祀子18-35份、女贞子18-35份、蛇床子18-35份、木鳖子18-35份、苍术18-35份、泽泻18-35份、车前子18-35份、石韦18-35份、草薛18-35份、虎杖18-35份、鹿茸18-35份、甘草18-35份、黄柏18-35份、苦参18-35份、白鲜皮18-35份、陈皮18-35份、积实18-35份、乌药18-35份、香附18-35份、香附18-35份。
所述的粉剂B部分包括以下重量份数原料药:白芥子10份、土鳖虫20份、三七6份、乳香6份、没药6份、川椒6份;以及按重量份数计还添加有下述原料药的一种或多种:全蝎10-35份、娱蛤10-35份、红花10-35份、姜黄10-35份、雪上一枝篙10-35份、寻骨风10-35份、草乌10-35份、地龙10-35份、甘草10-35份、秦芜10-35份、防风10-35份、五加皮10-35份、牛膝10-35份、丝瓜络10-35份、沙苑子10-35份、鸡血藤10-35份、僵蚕10-35份、川芍10-35份。
所述止痛消肿贴膏的制备方法,具体包括以下步骤。
步骤1、按处方中粉剂B部分的原料所需比例称取中药材,混合研细,过 40 一 120目筛待用。
步骤2、按处方中膏剂A部分的原料所需比例称取中药材,将药加入2000ml水煎三次,前两次100℃水煎三小时过滤,第三次煎两小时过滤,合并三次滤液熬成流浸膏200ml备用。
步骤3、取医用压敏热溶胶 1000g加热至 110-150 ℃时融化。
步骤4、将步骤1制得的药粉缓慢加入到步骤3制得的融化的热熔胶中,搅拌均匀。
步骤5、再加入步骤2制得的流浸膏和50ml氮酮,继续搅拌均匀得膏药。
实施例2临床实验。
1.资料与方法。
1.1一般资料。
自2017年05月-2019年05月辽宁中医药大学附属医院门诊及病房住院的类风湿关节炎(中医诊断痹证)患者210例,男85例,女125例;年龄最大80岁,最小16岁,平均53.3岁;病程最长为33年,最短为1.8个月,平均病程为8.34年,按就诊的先后顺序随机分成三组:治疗组70例、对照A组70例、对照B组70例,三组在年龄、性别、病程等方面比较无显著性差异(P>0.05),具有可比性。
1.2纳入、排除标准。
就诊时全部病例经症状、体征、病名、X线及理化指标检查确诊为类风湿关节炎,依据中药新药临床研究指导原则中医辨证为痰瘀血痹阻证型。排除妊娠期或哺乳期妇女;重叠其他风湿系统疾病,合并脑血管、心血管、肝、肾及造血系统等严重原发性疾病;精神病患者;法律规定的残疾患者(盲、聋、哑、智力障碍、精神障碍、肢体残疾);晚期关节炎重度畸形、僵硬、丧失劳动力患者;不能坚持治疗者。
1.3治疗方法。
治疗组给予来氟米特20mg,每日一次口服治疗,联合本实施例1用于外贴止痛消肿贴膏贴敷治疗。对照A组给予来氟米特20mg,每日一次口服治疗;对照B组予来氟米特20mg,每日一次口服治疗,联合穴位贴服本发明中药贴膏(已在临床应用10年)。治疗组、对照A组及对照B组在治疗过程中来氟米特用量维持不变,不加用其他控制病情药;不加用其他外用疗法。
来氟米特商品名为妥抒,为福建汇天生物有限公司生产,10mg/片。
贴膏外用法:每日1贴,贴于关节肿痛处,连续10天为一个疗程。
2.观察指标。
2.1一般项目:性别、年龄、身高、体重、病程、血压等项目。
2.2疗效指标检测:治疗前及治疗3个疗程后血沉(ESR)、C反应蛋白(CRP)、患者的DAS28(疾病活动度)评分。
3.疗效评价标准:参照《中药新药临床研究指导原则》制定。
3.1临床痊愈:症状完全消失,关节功能恢复正常,主要理化检查指标正常,疗效指数均≥95%。
3.2显效:主要症状消失,关节功能基本恢复,主要理化检查指标基本正常,疗效指数为70%-94%。
3.3有效:主要症状基本消失,主要关节功能及主要理化指标有所改善,疗效指数为30%-69%。
3.4无效:与治疗前相比,各方面均无改善,疗效指数<30%。
疗效指数计算公式(尼莫地平法)为:[(治疗前积分-治疗后积分)/治疗前积分]×100%。
4.统计分析:采用SPSS17.0软件包统计,计数资料采用X2检验,疗效指标采用t检验。
5.结果:两组患者治疗后安全性指标(血、尿、便常规、肝肾功能、血压)较治疗前比较无异常。
5.两组临床疗效比较,结果参见表1,表1为两组临床疗效比较。
表1:两组临床疗效比较。
注:采用X2检验,治疗组与对照A组和对照B组比较,均有显著性差异(P<0.05)。
综上所述,本发明用于外用治疗类风湿关节炎的中药贴膏与西药免疫抑制剂协同控制病情,疗效佳,不良反应少、成本低,可以明显减轻病人的痛苦,大大减少病人的经济负担。本次临床研究发现,本发明用于外用治疗类风湿关节炎的中药贴膏与来氟米特合用具有较好的控制病情作用,疗效优于单用来氟米特组。并对两种不同贴膏做比较,对照B组的外用贴膏为现有应用的贴膏,经对比,本实施例1配方疗效明显优于既往配方贴膏,说明本发明中药贴膏可获得更好的临床疗效,值得在临床上广泛推广应用。
实施例3 典型病例。
1. 类风湿关节炎。
病症:双膝关节肿痛,晨起明显,活动后加重。
临床诊断:类风湿关节炎。
临床表现:双膝关节肿胀、疼痛,活动加重。
达到的不良后果:影响日常行走活动,需要人照顾。
用药:所述的膏剂A部分由以下重量份原料药制成:防己20份、桂枝20份、独活30份、细辛10份、川乌50份、草乌50份、川椒30份、制附子50份、天南星90份、姜黄60份、桃仁30份、当归40份、乳香20份、没药20份;所述的粉剂B部分由以下重量份原料药制成:白芥子10份、土鳖虫20份、三七6份、乳香6份、没药6份、川椒6份。
用法:每日1贴,贴于膝关节肿痛处,连续10天。
疗效:患者1-2天疼痛明显减轻,5-10天关节肿痛明显改善,10天后关节活动有所改善,提高生活质量,且在贴膏药过程中患处不痒不难受,膏药也没有发生腐烂变质的情况。
2. 骨关节炎。
病症:双膝关节疼痛肿胀,活动后加重。
临床诊断:膝骨关节炎。
临床表现:双膝关节肿胀、疼痛,蹲起困难。
达到的不良后果:影响日常行走活动,需要辅助工具。
用药:所述的膏剂A部分由以下重量份原料药制成:防己20份、桂枝20份、独活30份、细辛10份、川乌50份、草乌50份、川椒30份、制附子50份、天南星90份、姜黄60份、桃仁30份、当归40份、乳香20份、没药20份以及按重量份数计还添加有下述原料药的一种或多种:生姜20-50份、绞股蓝20-50份、透骨草20-50份、荆芥20-50份、蚕沙20-50份、伸筋草20-50份、桑枝20-50份、丝瓜络20-50份、丹参20-50份、红花20-50份、桃仁20-50份、牛膝20-50份、鸡血藤20-50份、地龙20-50份、全蝎20-50份、续断20-50份;所述的粉剂B部分由以下重量份原料药制成:白芥子10份、土鳖虫20份、三七6份、乳香6份、没药6份、川椒6份。
用法:每日1贴,贴于膝关节肿痛处,连续10天。
疗效:患者1-2天疼痛明显减轻,10天一个疗程后膝关节活动有所改善,治疗3个疗程后肿痛基本消失,可自如蹲起。
3. 颈椎病。
病症:颈部疼痛,左上肢麻木疼痛,左肩抬举受限,头晕。
临床诊断:颈椎病。
临床表现:颈部疼痛,左上肢麻木疼痛,左肩抬举受限,头晕。
达到的不良后果:影响日常活动。
用药:所述的膏剂A部分由以下重量份原料药制成:防己20份、桂枝20份、独活30份、细辛10份、川乌50份、草乌50份、川椒30份、制附子50份、天南星90份、姜黄60份、桃仁30份、当归40份、乳香20份、没药20份以及按重量份数计还添加有下述原料药的一种或多种:远志18-35 份、钩藤18-35 份、僵蚕18-35 份、补骨脂18-35 份、海马18-35 份、沙苑子18-35 份、当归18-35 份、生地黄18-35 份、白芍18-35 份、构祀子18-35 份、女贞子18-35 份、蛇床子18-35 份、木鳖子18-35 份、苍术18-35 份、泽泻18-35 份、车前子18-35 份、石韦18-35 份、草薛18-35 份、虎杖18-35 份、鹿茸18-35 份、甘草18-35 份、黄柏18-35 份、苦参18-35 份、白鲜皮18-35 份、陈皮18-35 份、积实18-35 份、乌药18-35 份、香附18-35份、;所述的粉剂B部分由以下重量份原料药制成:白芥子10份、土鳖虫20份、三七6份、乳香6份、没药6份、川椒6份。
用法:每日1贴,贴于膝关节肿痛处,连续10天。
疗效:患者治疗1天,颈部疼痛明显减轻,治疗1个疗程10天后颈部疼痛及左上肢麻木疼痛明显改善。
4. 腰椎间盘突出。
病症:腰痛,放射至右下肢,行走困难。
临床诊断:腰椎间盘突出症。
临床表现:腰痛,放射至右下肢,行走困难。
达到的不良后果:不能久站、久坐、行走。
用药:所述的膏剂A部分由以下重量份原料药制成:防己20份、桂枝20份、独活30份、细辛10份、川乌50份、草乌50份、川椒30份、制附子50份、天南星90份、姜黄60份、桃仁30份、当归40份、乳香20份、没药20份以及按重量份数计还添加有下述原料药的一种或多种:远志18-35 份、钩藤18-35 份、僵蚕18-35 份、补骨脂18-35 份、海马18-35 份、沙苑子18-35 份、当归18-35 份、生地黄18-35 份、白芍18-35 份、构祀子18-35 份、女贞子18-35 份、蛇床子18-35 份、木鳖子18-35 份、苍术18-35 份、泽泻18-35 份、车前子18-35 份、石韦18-35 份、草薛18-35 份、虎杖18-35 份、鹿茸18-35 份、甘草18-35 份、黄柏18-35 份、苦参18-35 份、白鲜皮18-35 份、陈皮18-35 份、积实18-35 份、乌药18-35 份、香附 18-35份;所述的粉剂B部分由以下重量份原料药制成:白芥子10份、土鳖虫20份、三七6份、乳香6份、没药6份、川椒6份以及按重量份数计还添加有下述原料药的一种或多种:全蝎10-35份、娱蛤10-35 份、红花10-35 份、姜黄10-35 份、雪上一枝篙10-35 份、寻骨风10-35 份、草乌10-35 份、地龙10-35 份、甘草10-35 份、秦芜10-35 份、防风10-35 份、五加皮10-35份、牛膝10-35 份、丝瓜络10-35 份、沙苑子10-35 份、鸡血藤10-35 份、僵蚕10-35 份、川芍 10-35 份。
用法:每日1贴,贴于腰部、环跳、委中,连续10天。
疗效:患者治疗1天,腰部疼痛明显减轻,治疗1个疗程10天后腰痛明显缓解,可缓慢行走;治疗3个疗程患者腰痛及放射症状消失,行走自如。
Claims (10)
1.一种止痛消肿贴膏,其特征在于,所述贴膏由膏剂A和粉剂B混合而成。
2.如权利要求1所述的止痛消肿贴膏,其特征在于,所述的膏剂A部分包括以下重量份的原料药:防己20-90份、桂枝20-90份、独活20-90份、细辛20-90份、川乌20-90份、草乌20-90份、川椒20-90份、制附子20-90份、天南星20-90份、姜黄20-90份、桃仁20-90份、当归20-90份、乳香20-90份、没药20-90份。
3.如权利要求1所述的止痛消肿贴膏,其特征在于,所述的粉剂B部分包括以下重量份的原料药:白芥子6-20份、土鳖虫6-20份、三七6-20份、乳香6-20份、没药6-20份、川椒6-20份。
4.如权利要求1所述的止痛消肿贴膏,其特征在于,所述膏剂A部分按重量份数计还添加有下述原料药的一种或多种:生姜20-50份、绞股蓝20-50份、透骨草20-50份、荆芥20-50份、蚕沙20-50份、伸筋草20-50份、桑枝20-50份、丝瓜络20-50份、丹参20-50份、红花20-50份、桃仁20-50份、牛膝20-50份、鸡血藤20-50份、地龙20-50份、全蝎20-50份、续断20-50份。
5.如权利要求1所述的止痛消肿贴膏,其特征在于,所述膏剂A部分按重量份数计还添加有下述原料药的一种或多种:远志18-35 份、钩藤18-35 份、僵蚕18-35 份、补骨脂18-35份、海马18-35 份、沙苑子18-35 份、当归18-35 份、生地黄18-35 份、白芍18-35 份、构祀子18-35 份、女贞子18-35 份、蛇床子18-35 份、木鳖子18-35 份、苍术18-35 份、泽泻18-35 份、车前子18-35 份、石韦18-35 份、草薛18-35 份、虎杖18-35 份、鹿茸18-35 份、甘草18-35 份、黄柏18-35 份、苦参18-35 份、白鲜皮18-35 份、陈皮18-35 份、积实18-35 份、乌药18-35 份、香附18-35 份。
6.如权利要求1所述的止痛消肿贴膏,其特征在于,所述粉剂B部分按重量份数计还添加有下述原料药的一种或多种:全蝎10-35 份、娱蛤10-35 份、红花10-35 份、姜黄10-35份、雪上一枝篙10-35 份、寻骨风10-35 份、草乌10-35 份、地龙10-35 份、甘草10-35 份、秦芜10-35 份、防风10-35 份、五加皮10-35 份、牛膝10-35 份、丝瓜络10-35 份、沙苑子10-35 份、鸡血藤10-35 份、僵蚕10-35 份、川芍10-35份。
7.一种止痛消肿贴膏,所述贴膏由膏剂A和粉剂B混合而成,所述的膏剂A部分由以下重量份原料药制成:防己20份、桂枝20份、独活30份、细辛10份、川乌50份、草乌50份、川椒30份、制附子50份、天南星90份、姜黄60份、桃仁30份、当归40份、乳香20份、没药20份;所述的粉剂B部分由以下重量份原料药制成:白芥子10份、土鳖虫20份、三七6份、乳香6份、没药6份、川椒6份。
8.一种止痛消肿贴膏的制备方法,其特征在于,具体包括以下步骤:
步骤1、按处方中粉剂B部分的原料所需比例称取中药材,混合研细,过 40-120 目筛待用;
步骤2、按处方中膏剂A部分的原料所需比例称取中药材,将药加入2000ml水煎三次,前两次100℃水煎三小时过滤,第三次煎两小时过滤,合并三次滤液熬成流浸膏200ml备用;
步骤3、取医用压敏热溶胶500-1000g加热至 110-150 ℃时融化;
步骤4、将步骤1制得的药粉缓慢加入到步骤3制得的融化的热熔胶中,搅拌均匀;
步骤5、然后再加入步骤2制得的流浸膏和50-100ml氮酮,继续搅拌均匀得膏药。
9.如权利要求8所述的止痛消肿贴膏的制备方法,其特征在于,所述医用压敏热溶胶为黑胶、透明胶。
10.一种止痛消肿贴膏在制备治疗风湿性关节炎、骨质增生、滑膜炎、腰脱和各种关节疼痛肿胀的外用药物中的应用。
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CN116870128A (zh) * | 2023-08-03 | 2023-10-13 | 北京圣骨堂健康管理发展有限公司 | 一种用于治疗筋骨痛的组合药物及其制备方法 |
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