CN116173160A - 一种外用消肿止痛组方及其应用 - Google Patents
一种外用消肿止痛组方及其应用 Download PDFInfo
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- CN116173160A CN116173160A CN202211371113.3A CN202211371113A CN116173160A CN 116173160 A CN116173160 A CN 116173160A CN 202211371113 A CN202211371113 A CN 202211371113A CN 116173160 A CN116173160 A CN 116173160A
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Abstract
本发明公开了一种外用消肿止痛组方及其应用,该组方包括以下重量份的原料:制川乌10‑35份,制草乌10‑35份,千锤打10‑30份,飞天蜈蚣10‑30份,透骨草3‑20份,三七3‑20份,川芎3‑20份,红花3‑20份,栀子3‑20份,姜黄3‑20份,生大黄3‑20份,乳香10‑20份,没药10‑20份,制马钱子1‑3份,斑蝥1‑5份,红娘子3‑5份,血竭3‑10份,蓼子草5‑20份。该组方具有祛风散寒,清热除湿、活血化瘀、消肿止痛。适用于软组织损伤、关节疼痛、屈伸不利、手足不仁、筋脉挛痛,临床用于腰肌劳损、软组织损伤,骨折及关节脱位早期。本发明配方外用无任何毒副作用。
Description
技术领域
本发明属于医药领域,具体涉及一种外用消肿止痛组方及其应用。
背景技术
急性软组织损伤一般是由于不同因素造成皮肤以下骨骼以上的组织损伤,包括肌肉、韧带、筋膜、肌腱、滑膜、脂肪、关节囊等组织以及周围神经、血管的不同情况的急性损伤。临床主要表现为局部肿胀、疼痛、功能障碍、皮肤瘀斑等。慢性软损伤也可因急性治疗不及时所致。急性软组织损伤大多数是由于外部因素骤然作用于机体局部组织,造成机体闭合性损伤。从中医角度研究,通过辩证认为其病机为“气滞与血瘀”并见,机体损伤后局部气血无法正常运行,机体气血流通不畅,容易导致损伤局部血液凝聚出现血瘀与肿胀症状。采用“结者散之,逸者行之,留着攻之”的治疗法则,以活血化瘀、消肿止痛为主要治疗原则,通过促进机体气血循环运行,从而达到缓解损伤局部肿胀、疼痛的目的,有利于损伤组织的愈合。《圣济总录·折伤门》云:“若因伤折内动经络,血行之道不得宜通。瘀积不散,为肿为痛。”故在损伤后,由于血液无法正常运行,聚集在局部导致瘀血形成,瘀血没有及时消散,则机体出现疼痛、肿胀的症状。治疗方式应使血液通行流畅,减少瘀血的聚集。《医宗金鉴》云:“损伤之症,肿痛者,乃疲血凝结作痛也。”故在损伤早期主要是由于损伤局部血液不易流通,瘀血凝集而所致的疼痛,中医治疗疾病本着急则治其标的治则,故在损伤早期应以止痛、促进血液流通为主。
辩证论治思想是中医治疗疾病独有的特色,根据每一阶段疾病发展的特点进行对症用药。从古代到现代不断的医疗探索中,逐渐形成了动静结合、筋骨并重、内外兼治、分期用药的综合治疗体系,对治疗疾病有重要的指导意义。中医治疗软组织损伤的方法主要以内治法、外治法、按摩针灸、牵引理疗等为主。《理瀹骈文》:“外治之理,即内治之理,外治之药,亦即内治之药;所异者,法耳”。外治和内治法既可以各单独应用于治疗疾病之中,也可以两者联合使用配合,共奏疗效之曲。内治法治疗急性软组织损伤,以中药内服为主,具有药效持久的特点,但内服法由于治疗周期较长,病程拖延时间较久,对于急性损伤诊疗效果欠佳。外治法能够针对损伤部位进行治疗,具有发挥功效速度快的特点。中药外治的主要机理是提高痛域值、抗炎作用、改善代谢与循环等方面。外治法在治疗急性疾病中效果较好,具有疗效作用较快,并对机体副作用较小的优势。急性软组织损伤主要的病理变化为损伤性无菌性炎症,局部损伤组织细胞坏死、毛细血管扩张、白细胞浸润、水肿及出血等。
中医认为急性软组织损伤为筋肉、脉络损伤,瘀血凝滞局部,将其病机概括为“气滞与血瘀”并见,以活血化瘀、通络行气、消肿止痛为治疗原则。外用中药制剂治疗急性软组织损伤独具特色,临床疗效满意,具有诸多优势,可避免药物在口服给药后受胃中酸性环境和胃肠道黏液的影响;减少血药浓度峰谷变化,从而降低药物的不良反应;直接作用于靶部位发挥药理作用;减少给药次数,且患者可自主用药,用药依从性较高,在使用过程中,如发生不良反应,可随时中断给药。
经检索,CN202111386482.5一种筋骨消肿止痛膏,包括以下重量份的组分:威灵仙1-2份、血竭3-4份、制草乌1-2份、制川乌1-2份、五加皮1-2份、木瓜1-2份、牛膝1-2份、红花1-2份、生香附3-4份、三棱1-2份、莪术1-2份、皂刺3-4份、羌活1-2份、乳香1-2份、没药1-2份、三七3-4份、茜草1-2份、川芎2-3份、五灵脂1-2份、防己1-2份、辽细辛1-2份、透骨草1-2份、秦艽1-2份、赤芍1-2份、木鳖子1-2份、白术1-2份、冰片1-2份、樟脑1-2份。该配方有筋骨消肿止痛的作用,但是其有28味配方,配方太多,配伍不够科学合理,且全文没有实验数据证明其效果。
研发一种配伍更合理、疗效更好的外用消肿止痛组方具有重要意义。
发明内容
本发明旨在克服现有技术的问题,研发一种配伍更合理、疗效更好的外用消肿止痛组方,该组方具有祛风散寒,清热除湿、活血化瘀、消肿止痛的功效。
本发明的技术方案:
一种消肿止痛组方,包括制川乌、制草乌,该组方的原料按重量份计为:制川乌10-35份,制草乌10-35份,千锤打10-30份,飞天蜈蚣10-30份,透骨草3-20份,三七3-20份,川芎3-20份,红花3-20份,栀子3-20份,姜黄3-20份,生大黄3-20份,乳香10-20份,没药10-20份,制马钱子1-3份,斑蝥1-5份,红娘子3-5份,血竭3-10份,蓼子草5-20份。
优选方案:该组方的原料按重量份计为:制川乌25-35份,制草乌25-35份,千锤打15-25份,飞天蜈蚣15-25份,透骨草5-15份,三七5-15份,川芎5-15份,红花5-15份,栀子5-15份,姜黄5-15份,生大黄5-15份,乳香12-18份,没药12-18份,制马钱子1-3份,斑蝥1-5份,红娘子3-5份,血竭3-5份,蓼子草5-10份。
进一步优选方案:该组方的原料按重量份计为:制川乌35份,制草乌35份,千锤打25份,飞天蜈蚣25份,透骨草15份,三七15份,川芎12份,红花12份,栀子10份,姜黄10份,生大黄12份,乳香12份,没药12份,制马钱子2份,斑蝥2份,红娘子3份,血竭3份,蓼子草5份。
优选的制备方法为:
(1)将上述原材料洗净材洗净、晾干后备用;
(2)将上述原材料切成3mm-5mm,然后过100目-150目筛,置于密闭容器中,加70%-80%酒精至10000mL-15000mL,密封浸泡15天-20天;
(3)然后取上清液回收乙醇,回收乙醇,浓缩,中空干燥后,研细,过40目-50目筛,置于阴凉干燥处保存备用。
优选的,取上清液回收60℃-70℃乙浓缩至比重约为1.15~1.25(60℃),65℃-75℃中空干燥后,研细,过40目-50目筛,置于阴凉干燥处保存备用。
本发明的消肿止痛组方用于制备治疗急性软组织损伤的药物中的应用。
优选的,所述药物包括外用消肿止痛药物、祛风散寒药物、清热除湿药物或活血化瘀药物。
优选的,所述药物的剂型包括酊剂、软膏剂、乳膏剂、凝胶剂、贴剂、贴膏剂等。禁用于有皮肤破损处;禁用于口、鼻、眼等粘膜薄弱处;禁用于皮肤过敏者。适用于软组织损伤、关节疼痛、屈伸不利、手足不仁、筋脉挛痛,临床用于软组织损伤,骨折及关节脱位早期。本发明配方外用无任何毒副作用。
本发明的配伍理论基础为:本发明骨关节炎以慢性关节疼痛、僵硬、肥大与活动受限为主要表现。属于中医学“痹证”范畴。痹证是由于风、寒、湿、热等邪闭阻经络,导致以肢体筋骨、关节、肌肉等处发生疼痛、重着、酸楚、麻木,或关节屈伸不利、僵硬、肿大、变形等为主症的疾病。基本病机为风、寒、湿、热、痰、瘀等邪气滞留肌体、筋脉、关节、肌肉,经脉闭阻,气血不通。治疗以祛风散寒、清热除湿、活血化瘀、消肿止痛为根本大法。方中以制川乌、制草乌为君药,均为辛、苦,热,有大毒,均擅长祛风除湿、温经止痛,外用局部麻醉止痛。臣药:千锤打:祛风除湿、行气宽中、散瘀止痛。增强二乌祛风除湿,温经止痛作用。飞天蜈蚣:消肿止痛。佐药:乳香、没药:辛、苦,温,具有活血行气止痛、消肿生肌之功效。川芎:辛,温,活血行气,祛风止痛,为血中气药。姜黄:辛、苦,温,活血行气,调经止痛。红花:辛,温,活血通经,散瘀止痛。马钱子:苦,温,有大毒,活血通络止痛,散结消肿。血竭:甘、咸,平,活血化瘀、止血、敛疮生肌。斑蝥:破血逐瘀,散结消癥,攻毒蚀疮。三七:散瘀止血,消肿定痛。大黄:外用清热消肿、疗烫伤。栀子:外用消肿止痛。透骨草:甘、辛,温。具有祛风除湿、舒经活络、活血止痛、解毒化疹。《本草纲目》曰:蓼子草:散寒活血。红娘子:性平,味苦,有小毒。有破瘀,散结,攻毒。使药:酒为引经药,白酒浸泡,可借助酒的穿透力,充分透发药物的有效成份,增强药物的渗透性使人体组织容易吸收,从而达到活血化瘀,促进瘀血吸收,消肿止痛之目的,诸药同用,共呈祛风散寒、清热除湿、活血化瘀、消肿止痛之功。本发明遵循中医理论及方剂配伍理论进行配伍,原料使用剂量均在安全范围内,各原料协调配伍,具有祛风散寒,清热除湿、活血化瘀、消肿止痛的功效。
本发明外用消肿止痛组方具有以下优点:能有效缓各种腰部、关节疼痛、屈伸不利、手足不仁、筋脉挛痛等不适,以及修复长期腰肌劳损所致的损伤,临床用于腰肌劳损、软组织损伤,骨折及关节脱位早期。本组方和现有技术的各种外用制剂相比,具有起效快、疗效显著、使用方便、无副作用、治愈率高等特点。
附图说明
图1是外用不同组方对大鼠软组织损伤肌肉组织病理学检查图(HE x200),其中:图1(a)是正常对照组给药后1天的检查图;图1(b)是正常对照组给药后3天的检查图;图1(c)是模型对照组给药后1天的检查图;图1(d)是模型对照组给药后3天的检查图;图1(e)是阳性对照组(消肿止痛酊)给药后1天的检查图;图1(f)是阳性对照组(消肿止痛酊)给药后3天的检查图;图1(g)是外用组方1组给药后1天的检查图;图1(h)外用组方1组给药后3天的检查图;图1(i)是外用组方2组给药后1天的检查图;图1(j)是外用组方2组给药后3天的检查图;图1(k)是外用组方3组给药后1天的检查图;图1(L)是外用组方3组给药后3天的检查图;图1(m)是正常对照组给药后7天的检查图;图1(n)是模型对照组给药后7天的检查图;图1(o)是阳性对照组(消肿止痛酊)给药后7天的检查图;图1(p)是外用组方1组给药后7天的检查图;图1(q)是外用组方2组给药后7天的检查图;图1(r)是外用组方3组给药后7天的检查图。
具体实施方式
实施例1
一种消肿止痛组方,原料为:制川乌35份,制草乌35份,千锤打25份,飞天蜈蚣25份,透骨草15份,三七15份,川芎12份,红花12份,栀子10份,姜黄10份,生大黄12份,乳香12份,没药12份,制马钱子2份,斑蝥2份,红娘子3份,血竭3份,蓼子草5份。
制备方法:(1)将上述原材料洗净材洗净、晾干后备用;(2)将上述原材料打粉,然后过100目筛,置于密闭容器中,加75%酒精至10000mL,密封浸泡15天;
(3)然后取上清液,60℃回收乙浓缩至比重约为1.15~1.25(60℃),70℃中空干燥后,研细,过40目筛,置于阴凉干燥处保存备用。
对比例1
对比组方:原料为:制川乌35份,制草乌35份,透骨草15份,三七15份,川芎12份,红花12份,栀子10份,姜黄10份,生大黄12份,乳香12份,没药12份,共11味,制备方法同实施例1。
对比例2
对比组方:原料为:制川乌35份,制草乌35份、透骨草15份,三七15份,川芎12份,红花12份,栀子10份,姜黄10份,制马钱子2份,斑蝥2份,红娘子3份,血竭3份,蓼子草5份,13味,制备方法同实施例1。
应用实例:
应用例1:外用组方对大鼠软组织损伤模型的影响
雄性SD大鼠60只,体重230~260g,造模前将大鼠右腿脱毛,用2%戊巴比妥钠腹腔麻醉,固定于软组织打击器上,右腿外展固定,于右大腿中部外侧软组织标记定位,将500g打击锤拉至约17cm高度,松开打击锤,自由落下,连续击打7次,造成局部急性软组织损伤(面积约为3*3cm2)。以无骨折,无皮肤破裂为标准,造模后动物按体重随机分为7组,分别为模型对照组、消肿止痛酊组、外用组方1(对比例1的组方),组方2(对比例2的组方)组;组方3组(实施例1的组方),每组18只。另取18只不作处理大鼠作为正常对照组。造模当天各组动物在损伤部位外敷给药,0.2mL/只,2次/日,连续给药7天。分别测定造模前和造模后1h以及给药后1、3、7天损伤标记处的周长,分别于给药后1、3、7天每组分别取6只大鼠解剖,对损伤肌肉组织形态学观察和病理学检查。
实验结果:与正常对照组比较,给药后第1、3、7天,模型对照组大鼠损伤部位周长明显增加(P≤0.01);与模型对照组比较,给药后7d,外用组方3组大鼠损伤部位周长明显减少(P≤0.01或P≤0.05);给药3d、7d后,外用组方3剂量组大鼠损伤部位周长明显减少(P≤0.01或P≤0.05);阳性消肿止痛酊均能明显减少大鼠损伤部位周长(P≤0.01或P≤0.05)。(见表1)
正常对照组动物皮下组织无病理变化;模型对照组组造模后第2天,皮下组织可见大量炎症细胞浸润,炎症程度最为严重;造模后第3天,皮下组织可见少量红细胞,炎症细胞浸润,炎症程度有所减轻;造模后第7天,皮下组织血管充血、出血,间质轻度水肿,炎症程度进一步减轻。外用组方1、2、3剂量组,给药后第1天,皮下组织可见大量红细胞,炎症细胞浸润,炎症程度最为严重;给药后第3天,外用组方3组大鼠皮下组织可见大量散在红细胞,纤维组织增生,间质少量炎症细胞浸润,炎症程度有所减轻;给药后第7天,外用组方2、3组皮下组织可见大量红细胞,间质轻度水肿,炎性细胞浸润,炎症程度进一步减轻。消肿止痛酊组,给药后第1天,皮下组织可见大量散在红细胞,间质少量炎症细胞浸润,炎症程度最为严重;给药后第3天,皮下组织可见大量散在红细胞,间质少量炎症细胞浸润,炎症程度明显减轻;给药后第7天,皮下组织血管轻度充血,间质少量散在炎性细胞,炎症程度进一步减轻,已经基本恢复。
由实施例1可知,组方3的效果优于消肿止痛酊组、优于组方1和组方2。
注:与正常对照组相比,**P≤0.01;与模型对照组相比,+P≤0.05,++P≤0.01。应用例2:不同组方对小鼠醋酸扭体的影响
SPF级ICR小鼠50只,雌雄各半,体重18.7~23.3g,实验前脱毛处理,腹部脱毛面积2cm×2cm,按性别体重随机分成5组,每组10只,分别为模型对照组、消肿止痛酊组、外用组方1、2、3组。每天给药2次,0.2ml/只,连续给药7天,末次给药后1h,各组小鼠腹腔注射0.7%的醋酸溶液(现用现配,0.1mL/10g)致痛。记录注射冰醋酸后15min内每只小鼠的扭体次数。以小鼠腹部收缩内凹,躯干与后肢伸展臀部与一侧肢体内旋为标准计算扭体次数。
实验结果:与模型对照组比较,外用组方3小鼠扭体次数明显减少(P≤0.01),消肿止痛酊能明显减少小鼠扭体次数(P≤0.01)。与消肿止痛酊组比较,外用组方3组小鼠扭体次数显著减少(P≤0.01),(见表3),且明显优于组方1组和组方2组。
注:与模型对照组比较+P≤0.05,++P≤0.01;与消肿止痛酊组比较,##P≤0.01。
应用例3:不同组方对大鼠类风湿性关节炎肿胀的影响
雄性SD大鼠60只,体重180~220g,选取10只大鼠作为正常对照组,其余大鼠每只足趾中部注射0.1mL的完全乳剂(鸡Ⅱ型胶原20mg,溶于0.05M冰醋酸10mL中,与等体积弗氏完全佐剂混合制成乳剂),14天后足部皮肤加强免疫1次,建立大鼠类风湿性关节炎模型,观察6周,根据踝关节肿胀度随机分为5组,分别为:模型对照组、消肿止痛酊组、外用组方1、2、3组,每组10只,正常对照组和模型对照组大鼠给予0.9%氯化钠注射液,其余各组大鼠踝关节均匀涂抹相应药物,给药体积为0.2mL/只,1次/天,连续28天。给药期间每周及末次给药后采用皮尺检测大鼠踝关节肿胀度。
实验结果:与正常对照组比较,模型对照组大鼠在给药D1-28足趾容积明显增加(P<0.01)。与模型对照组比较,外用消肿组方2组大鼠在给药D28足趾容积明显减少(P<0.05),外用组方3组大鼠在给药D22-28足趾容积明显减少(P<0.05)。消肿止痛酊组大鼠在给药D15-28足趾容积明显减少(P<0.05)(表4),且组方3组的效果优于组方1和组方2的效果。
注:与正常对照组比较,++P<0.01;与模型对照组比较,*P<0.05。
综上表明,本发明的外用组方3对软组织损伤、关节炎疼痛效果明显,起效时间快,且改善效果优于消肿止痛酊,且无不良反应。
上面所述只是为了说明本发明,应该理解为本发明并不局限于以上实施例,在所属技术领域技术人员所具备的知识范围内,还可以在不脱离本发明宗旨的前提下而引伸出的各种变化。
Claims (7)
1.一种消肿止痛组方,包括制川乌、制草乌,其特征是,该组方的原料按重量份计为:制川乌10-35份,制草乌10-35份,千锤打10-30份,飞天蜈蚣10-30份,透骨草3-20份,三七3-20份,川芎3-20份,红花3-20份,栀子3-20份,姜黄3-20份,生大黄3-20份,乳香10-20份,没药10-20份,制马钱子1-3份,斑蝥1-5份,红娘子3-5份,血竭3-10份,蓼子草5-20份。
2.根据权利要求1所述消肿止痛组方,其特征是,该组方的原料按重量份计为:制川乌25-35份,制草乌25-35份,千锤打15-25份,飞天蜈蚣15-25份,透骨草5-15份,三七5-15份,川芎5-15份,红花5-15份,栀子5-15份,姜黄5-15份,生大黄5-15份,乳香12-18份,没药12-18份,制马钱子1-3份,斑蝥1-5份,红娘子3-5份,血竭3-5份,蓼子草5-10份。
3.根据权利要求2所述消肿止痛组方,其特征是,该组方的原料按重量份计为:制川乌35份,制草乌35份,千锤打25份,飞天蜈蚣25份,透骨草15份,三七15份,川芎12份,红花12份,栀子10份,姜黄10份,生大黄12份,乳香12份,没药12份,制马钱子2份,斑蝥2份,红娘子3份,血竭3份,蓼子草5份。
4.根据权利要求1-3中任意一项所述消肿止痛组方,其特征是,制备方法为:
(1)将上述原材料洗净材洗净、晾干后备用;
(2)将上述原材料切成3mm-5mm,然后过100目-150目筛,置于密闭容器中,加70%-80%酒精至10000mL-15000mL,密封浸泡15天-20天;
(3)然后取上清液回收乙醇,减压浓缩至稠膏,真空干燥,粉碎,研细,过40目-50目筛,置于阴凉干燥处保存备用。
5.权利要求1-4中任意一项所述消肿止痛组方用于制备治疗急性软组织损伤的药物中的应用。
6.权利要求5所述应用,其特征是,所述药物包括外用消肿止痛药物、祛风散寒药物、清热除湿药物或活血化瘀药物。
7.权利要求5所述应用,其特征是,所述药物的剂型包括酊剂、软膏剂、乳膏剂、凝胶剂、贴剂、贴膏剂。
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