CN113713066A - 一种跌打损伤酒剂及其制备方法 - Google Patents
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Abstract
本发明公开了一种用于改善急性软组织损伤所导致的皮下淤血与肌肉肿胀,温和有效,副作用小的一种跌打损伤酒剂及其制备方法,其特征在于由原料归尾、乳香、红花、赤芍、牛膝、细辛、芝麻、高良姜、土鳖虫、防风、大血藤、白芷、羌活、桔梗、续断、乌药、槟榔、陈皮、生地黄、没药、黄酒等制成;本发明工艺简单,药物组成相辅相成;采用低度黄酒控时浸泡药物,酒精含量低,服用顺口,病人易接受;药性温和,对胃肠刺激和肝肾损伤小;回流提取能有效提高组方药物的利用率和药效,药效作用与双氯芬酸钠相当,但副作用小,安全性更高;能显著改善急性软组织损伤所导致的皮下淤血与肌肉肿胀,具有十分良好的活血化瘀与消肿功效和抗炎作用。
Description
技术领域
本发明涉及中药制剂技术领域,具体地说涉及一种跌打损伤酒剂及其制备方法。
背景技术
酒剂又名药酒,系用含有酒精的溶剂浸提药材而制得的澄明液体制剂。酒本身有行血活络的功效,易于吸收和发散,因此酒剂通常主用于风寒湿,具有祛风活血、止痛散瘀的功能。制备药酒一般采用精酿白酒、黄酒和米酒做酒基。白酒含乙醇量多为50%~60%,因高浓度的酒精含量会刺激消化道,加快血液速度,增加心脏负担,抑制甲状腺分泌等,所以以白酒制得的药酒不适合高血压、心脏病、胃溃疡、支气管炎和哮喘患者服用。而酒的度数越高,浸出效果越好。通常40~60度高度酒溶解、浸出药材的有效成分的效力强且时间短,随之药酒功效也增强。
黄酒的酒精含量多为14%~20%,属于低度酿造酒。黄酒是医学上很重要的辅料或“药引子”。 黄酒的含有许多易被人体消化的营养物质,以及多种人体自身不能合成而又必需的氨基酸,且含量比同量啤酒.葡萄酒多一至数倍。且易于消化,有促进食欲的作用。黄酒气味苦、甘、辛。冬天温饮黄酒,可活血祛寒、通经活络,有效抵御寒冷刺激,预防感冒。适量常饮有助于血液循环,促进新陈代谢,并可补血养颜。黄酒中镁、硒等多种微量元素的含量较高,在心血管疾病中,这些微量元素均有防止血压升高和血栓形成的作用。因此,适量饮用黄酒,对心脏有保护作用。对于风湿病的缓解的效果也比较好。
酒剂可用浸渍、渗漉、回流等方法制备。浸渍包括冷浸法和热浸法。冷浸法是将药材与规定量的酒共置于密闭容器内,室温下浸渍,定期搅拌,一般浸渍30日以上,取上清液,压榨药渣,压榨液与上清液合并,必要时加入适量糖或蜂蜜矫味,搅拌均匀,再静置沉降14日以上,滤过,滤液灌装于干燥、洁净的容器内,密闭,即得。该法生产周期较长,制得的酒剂澄明度较好。热浸法是将药材与规定量酒置于有益容器中,水浴或蒸汽加热至沸后立即停止加热,然后倾入另一有盖容器中,密闭,在室温下浸渍一至数月,定期搅拌,再吸取上清液,压榨药渣,将上清液与压榨液合并,根据需要加入糖或蜜,静置沉降1~2周,滤过,灌装,即可。渗漉法是取适当粉碎的药材,按渗漉法操作,收集渗漉液,若处方中需加糖或蜂蜜矫味者,可加入渗境液中,搅匀密闭,静置一定时间,滤过后灌装,即得。回流热浸法以白酒为溶剂,按回流热浸法提取至白酒近无色,合并回流提取液,加入蔗糖或蜂蜜,搅拌溶解后,密闭静置一段时间,滤过,分装,即得。
双氯芬酸钠是属于一种非甾体的抗炎止痛药物,主要的作用是可以用来控制疼痛,同时也可以降低炎症指标。双氯芬酸钠有明显的镇痛,消炎和解热的作用,对各种疼痛尤其是风湿,类风湿性关节炎引起的疼痛效果佳。该药通过抑制前列腺素的合成而产生镇痛、抗炎、解热作用。故属于抗炎镇痛类药物的典型代表药物之一,常常用于骨科各类轻中度急慢性疼痛的治疗,如骨关节炎,类风湿关节炎,强直性脊柱炎等。对于所有的双氯芬酸钠之类的非甾体止痛药物,主要的副作用是会出现胃肠受累,轻者会出现如恶心,呕吐,嗳气,腹痛之类的表现,严重的患者甚至还会出现胃溃疡、胃出血,呕血甚至穿孔之类的重症。头痛,头晕,嗜睡,兴奋等副作用也是很常见的副作用。少数患者会出现四肢水肿,尿少,电解质紊乱等不良反应。少见的副作用有转氨酶升高,黄疸,粒细胞减少,血小板减少等。所以,对于使用非甾体止痛药物的患者,常规建议可以使用泮托拉唑来预防胃肠道反应。同时双氯芬酸钠也会出现肝功能、肾功能的受损,在使用双氯芬酸钠的过程中,要监测肝肾功能的变化。
发明内容
本发明的目的是提供一种用于改善急性软组织损伤所导致的皮下淤血与肌肉肿胀,温和有效,副作用小的一种跌打损伤酒剂及其制备方法。
本发明是采用如下技术方案实现其发明目的的,一种跌打损伤酒剂,由以下配比原料制成:
归尾40g~60g,乳香80g~120g,红花40g~100g,赤芍40g~60g,牛膝40g~60g,细辛40g~60g,芝麻40g~60g,高良姜40g~60g,土鳖虫40g~60g,防风40g~60g,大血藤40g~60g,白芷40g~60g,羌活40g~60g,桔梗40g~60g,续断40g~60g,乌药40g~60g,槟榔40g~60g,陈皮40g~60g,生地黄40g~60g,没药0.010g~0.050g,龙胆草40g~60g,桃仁40g~60g,大黄40g~60g,三七40g~60g,茴香40g~60g,五加皮40g~60g,木瓜40g~60g,枳壳40g~60g,肉桂40g~60g,柴胡40g~60g,桂枝40g~60g,甘遂40g~60g,杜仲40g~60g,附子40g~60g,黄酒3kg~4kg。
一种跌打损伤酒剂,优选的,由以下配比原料制成:归尾50g,乳香100g,红花100g,赤芍50g,牛膝50g,细辛50g,芝麻50g,高良姜50g,土鳖虫50g,防风50g,大血藤50g,白芷50g,羌活50g,桔梗40,续断50g,乌药50g,槟榔50g,陈皮50g,生地黄50g,没药0.010g,龙胆草50g,桃仁50g,大黄50g,三七50g,茴香50g,五加皮50g,木瓜50g,枳壳50g,肉桂50g,柴胡50g,桂枝50g,甘遂50g,杜仲50g,附子50g,黄酒4kg。
本发明所述的附子为白附片。
如上述的一种跌打损伤酒剂的制备方法,包括以下步骤:
⑴分别将归尾、红花、赤芍、牛膝、细辛、芝麻、高良姜、土鳖虫、防风、大血藤、白芷、羌活、桔梗、续断、乌药、槟榔、陈皮、生地黄、龙胆草、桃仁、大黄、三七、茴香、五加皮、木瓜、枳壳、肉桂、柴胡、桂枝、甘遂、杜仲、附子进行粉粹后,按配比混合均匀,备用;
⑵将乳香、没药捣碎为小块;按配比混合均匀,备用;
⑶将步骤⑴、步骤⑵所得的备用混合药进行混合后装入可密封的容器内,按配比加入黄酒;
⑷热浸后,冷却,滤出药渣,密封静置,取上清液,既得。
本发明步骤⑴中所述的原料配比为归尾40g~60g,红花40g~100g,赤芍40g~60g,牛膝40g~60g,细辛40g~60g,芝麻40g~60g,高良姜40g~60g,土鳖虫40g~60g,防风40g~60g,大血藤40g~60g,白芷40g~60g,羌活40g~60g,桔梗40g~60g,续断40g~60g,乌药40g~60g,槟榔40g~60g,陈皮40g~60g,生地黄40g~60g,龙胆草40g~60g,桃仁40g~60g,大黄40g~60g,三七40g~60g,茴香40g~60g,五加皮40g~60g,木瓜40g~60g,枳壳40g~60g,肉桂40g~60g,柴胡40g~60g,桂枝40g~60g,甘遂40g~60g,杜仲40g~60g,附子40g~60g;
所述的步骤⑵中乳香、没药的配比为乳香80g~120g,没药0.010g~0.050g。
本发明步骤⑴中所述的附子为白附片;所述的步骤⑶中的黄酒为8~20度。
本发明步骤⑷中所述的热浸为加热提取,当液面沸腾出现泡沫时停止加热,冷却,滤出药渣;所述的静置时间为7天~10天,取上清液400目过滤。
本发明所述的步骤⑷中密封容器的上方设有回流冷却器,所述的加热提取为采用回流提取法回流提取1小时~1.5小时使混合药和黄酒的混合物保持微沸。
归尾即当归尾,是中药材中当归的尾部当,为伞形科植物当归Angelica sinensis(Oliv.)Diels的支根。全当归根略呈圆柱形,被人们分为三部分,根上端头部称“归头”,中部主根称“归身”或“寸身”.尾部支根称“归尾”或“归腿”,全体称“全归”。全当归既可补血又可活血,当归身偏于补血、养血,当归尾活血。经常用于血虚萎黄、眩晕心悸、月经不调、经闭痛经、虚寒腹痛、肠燥便秘、风湿痹痛、跌扑损伤、痈疽疮疡。归尾含有大量的维生素,对于动脉硬化方面具有很好的治疗作用。另外归尾对于降低血压、促进血液循环等方面都有很好的作用。归尾还具有治疗中风的作用。
红花(拉丁学名:Carthamus tinctorius L.)为桔梗目菊科红花属植物的干燥管状花。别名红蓝花、刺红花。橙红色,花管狭细,先端5裂,裂片狭线形,花药黄色,联合成管,高出裂片之外,其中央有柱头露出。具特异香气,味微苦。以花片长、色鲜红、质柔软者为佳。性味辛,温。主治妇女病,具有活血通经,散瘀止痛,活血化瘀,散湿去肿的功效的功效。有助于治经闭、痛经、恶露不行、胸痹心痛、瘀滞腹痛、胸胁刺痛、跌打损伤、疮疡肿痛疗效。
赤芍为毛茛科植物芍药或川赤芍的干燥根。味苦,性微寒。归肝经。有清热凉血,活血祛瘀的功效。用于热入营血,温毒发斑,吐血衄血,目赤肿痛,肝郁胁痛,经闭痛经,瘾瘕腹痛,跌扑损伤,痈肿疮疡。
牛膝为苋科植物牛膝Achyranthes bidentata Bl.的干燥根。性味苦、甘、酸,平。具有逐瘀通经,补肝肾,强筋骨,利尿通淋,引血下行的功能。用于经闭,痛经,腰膝酸痛,筋骨无力,淋证,水肿,头痛,眩晕,牙痛,日疮,吐血,衄血。
芝麻,又名脂麻、胡麻(学名:Sesamum indicum),是胡麻的籽种。芝麻有补肝肾,益精血,润肠燥,通乳的功效。可用于治疗身体虚弱、头晕耳鸣、高血压、高血脂、咳嗽、身体虚弱、头发早白、贫血萎黄、津液不足、大便燥结、乳少、尿血等症。
细辛为马兜铃目马兜铃科植物北细辛、汉城细辛或华细辛的干燥根和根茎。性味辛,温,有小毒,归心、肺、肾经。具有解表散寒,祛风止痛,通窍,温肺化饮的功能。主治风寒感冒,头痛,牙痛,风湿痹痛,鼻渊,肺寒咳嗽。
高良姜为姜科植物高良姜Alpinia officinarum Hance的干燥根茎。味辛,性热,归脾、胃经。具有温胃止呕,散寒止痛的功效。用于脘腹冷痛,胃寒呕吐,嗳气吞酸。
桂枝为樟目樟科植物肉桂的干燥嫩枝。味辛、甘,性温。归心、肺、膀胱经。具有发汗解表、散寒止痛、温通经脉,通阳化气,平冲降气的功效。常用于风寒感冒,脘腹冷痛,血寒经闭,关节痹痛,痰饮,水肿,心悸等。
附子为毛茛科植物乌头Aconitum carmichaelii Debx的子根的加工品。味辛、甘,性大热。归心、肾、脾经。具有回阳救逆,补火助阳,散寒止痛的功效。用于亡阳虚脱,肢冷脉微,心阳不足,胸痹心痛,虚寒吐泻,脘腹冷痛,肾阳虚衰,阳痿宫冷,阴寒水肿,阳虚外感,寒湿痹痛。附子按泡制方法的不同可分为盐附子、黑顺片、白附片、淡附片和炮附片。白附片,是将附子剥去外皮、切片,在清水中漂至水呈乳白色,取出蒸过、晒干,或用硫黄薰白。是大温热之药,有回阳救逆、温肾助阳、祛寒止痛的功效,用于肾阳不足、畏寒肢冷、风寒湿痹等症。
土鳖虫为鳖蠊科昆虫地鳖Eupolyph,aga sin,ensis Walker或冀地鳖Steleophaga Plancyi (Boleny)的雌虫干燥体。味咸,性寒,归肝经。具有破血逐瘀,续筋接骨之功效。用于跌打损伤,筋伤骨折,血瘀经闭,产后瘀阻腹痛,瘾瘕痞块。
大血藤为木通科植物大血藤Sargentodoxa cuneata (Oliv.)Rehd.et Wils.的干燥藤茎。味苦,性平。归大肠、肝经。具有清热解毒,活血,祛风止痛的功效。用于肠痈腹痛,热毒疮疡,经闭,痛经,跌扑肿痛,风湿痹痛。
防风为伞形科植物防风的根。味辛、甘,性微温。归膀胱、脾、肝经。有祛风解表,胜湿止痛,止痉的功效。用于外感表证,风疹瘙痒,风湿痹痛,破伤风正,脾虚湿盛。
白芷为伞形科植物白芷或杭白芷的干燥根。味辛,性温。归肺,脾,胃经。有解表散寒,祛风止痛,通鼻窍,祛病除湿、燥湿止带、祛风止痒,消肿排脓生肌、活血止痛等功能。主治风寒感冒、头痛、鼻炎、牙痛。风湿痹痛,鼻渊,赤白带下、痛疖肿毒等症。
羌活别名羌青、护羌使者、胡王使者、羌滑、退风使者、黑药,为伞形科羌活属植物羌活的干燥根。其性温,入膀胱、肾经。具有解表散寒、祛寒湿、止痛的功效。用于外感风寒、头痛无汗、寒湿痹、上肢风湿疼痛,项强筋急,骨节酸疼,风水浮肿,痈疽疮毒。
续断为川续断科多年生草本植物川续断Dipsacus asper Wall.ex Henry的干燥根,因能“续折接骨”而得名。《滇南本草》:“补肝,强筋骨,定经络,止经中(筋骨)酸痛,安胎,治妇人白带,生新血,破瘀血,落死胎,止咳嗽咳血,治赤白便浊。”其性微温,味苦、辛;归肝、肾经。有补肝肾、强筋骨、续折伤、止崩漏、调血脉的功效,可用于治疗肝肾不足、腰膝酸软、足膝无力,风湿痹痛、筋伤骨折、崩漏、胎漏、带下,遗精,跌扑损伤,金疮,痔漏,痈疽疮肿等病症。其中酒续断多用于风湿痹痛、筋伤骨折、跌扑损伤,盐续断多用于腰膝酸软。
乌药为樟科植物乌药Lindera aggregata( Sims) Kosterm.的干燥块根。性味辛,温。归肺、脾、肾、膀胱经。具有行气止痛,温肾散寒的功效。用于寒凝气滞,胸腹胀痛,气逆喘急,膀胱虚冷,遗尿尿频,疝气疼痛,经寒腹痛。
槟榔为单子叶植物纲、初生目、棕榈科、槟榔槟榔Areca catechu L.的干燥成熟种子。味苦、辛,性温。槟榔具有杀虫,破积,降气行滞,行水化湿,截疟的功效,用来治疗绦虫、钩虫、蛔虫、绕虫、姜片虫等寄生虫感染。,用于虫积腹痛,积滞泻痢,里急后重,水肿脚气,疟疾。
桔梗为桔梗科植物桔梗Platycodon grandiflorus(Jacq.)A.Dc.的干燥根。味苦、辛,性平。具有宣肺,利咽,祛痰,排脓的功效。用于咳嗽痰多,胸闷不畅,咽痛音哑,肺痈吐脓。
陈皮为芸香科植物橘Citrus reticulata Blanco及其栽培变种的干燥成熟果皮。味苦、辛,性温。具有理气健脾,燥湿化痰的功效。用于脘腹胀满,食少吐泻,咳嗽痰多。
生地黄为玄参科地黄属多年生草本植物地黄(拉丁学名:Rehmannia glutinosa(Gaetn.) Libosch. ex Fisch. et Mey.)的干燥块根。地黄根茎肉质,鲜时黄色,将地黄缓缓烘焙至约八成干,习称生地黄。生地黄性味甘,寒,归心、肝、肾经。具有清热凉血,养阴,生津的功效。用于热病舌绛烦渴,阴虚内热,骨蒸劳热,内热消渴,吐血,衄血,发斑发疹。
乳香为橄榄科植物乳香树Boswellia carterii Birdw.及同属植物Boswelliabhaurdajiana Birdw.树皮渗出的树脂。本品呈长卵形滴乳状、类圆形颗粒或粘合成大小不等的不规则块状物。大者长达2cm(乳香珠)或5cm(原乳香)。表面黄白色,半透明,被有黄白色粉末,久存则颜色加深。质脆,遇热软化。破碎面有玻璃样或蜡样光泽。具特异香气,味微苦。常采用醋炙法炮制。性味辛、苦、温。具有活血行气止痛,消肿生肌的功效。用于胸痹心痛,胃脘疼痛,痛经经闭,产后瘀阻,症瘕腹痛,风湿痹痛,筋脉拘挛,跌打损伤,痈肿疮疡。
没药为橄榄科植物地丁树Commiphora myrrha Engl.或哈地丁树Commiphoramolmol Engl.的干燥树脂。分为天然没药和胶质没药。味辛、苦,性平。具有散瘀定痛,消肿生肌之功效。常用于胸痹心痛,胃脘疼痛,痛经经闭,产后瘀阻,癥瘕腹痛,风湿痹痛,跌打损伤,痈肿疮疡等病症的治疗。
龙胆草(学名丝裂沙参Adenophora capillaris )为桔梗目桔梗科,沙参属多年生草本植物,龙胆的根茎及根经过干燥都可以入药,具有清热燥湿,泻肝胆实火的功效。性味苦,寒,归肝、胆经。用于湿热黄疸,阴肿阴痒,带下,湿疹瘙痒,肝火目赤,耳鸣耳聋,胁痛口苦,强中,惊风抽搐。
桃仁为蔷薇科植物桃Prunus persica(L.)Batsch或山桃Prunus davidiana(Carr.)Franch.的干燥成熟种子。果实成熟后采收,除去果肉和核壳,取出种子,晒干。味辛、苦,性平。具有活血祛瘀,润肠通便,止咳平喘的功效。用于经闭痛经,症瘕痞块,肺痈肠痈,跌扑损伤,肠燥便秘,咳嗽气喘。
大黄为蓼科植物掌叶大黄Rheum palmatum L.、唐古特大黄Rheum tanguticumMaxim. ex Baif.或药用大黄Rheum officinale Baill.的干燥根及根茎。秋末茎叶枯萎或次春发芽前采挖,除去细根,刮去外皮,切瓣或段,绳穿成串干燥或直接干燥。性味:苦,寒。具有泻实热,下积滞,行瘀,解毒。用于实热便秘,积滞腹痛,湿热黄疸,急性阑尾炎,不完全性肠梗阻,血瘀经闭,痈疖疔疮,化脓性皮肤病,烧、烫伤。
三七为五加科植物三七Panaxnotoginseng(Burk.)F.H.Chen的干燥根和根茎。味甘、微苦,性温。具有化瘀止血,活血定痛的功效。主治出血症,跌打损伤,瘀血肿痛。用于咯血,吐血,衄血,便血,崩漏,外伤出血,胸腹刺痛,跌扑肿痛。
肉桂为樟科植物肉桂Cinnamomum cassia Presl的干燥树皮。味辛、甘,性大热。归肾、脾、心、肝经。具有补火助阳,引火归元,散寒止痛,温通经脉的功效。用于阳痿宫冷,腰膝冷痛,肾虚作喘,虚阳上浮,眩晕目赤,心腹冷痛,虚寒吐泻,寒疝腹痛,痛经经闭。
茴香为伞形科植物茴香的果实。性味辛,温。具有温肾散寒,和胃理气的功效。治寒疝,少腹冷痛,肾虚腰痛,胃痛,呕吐,干、湿脚气。
五加皮为五加科植物细柱五加Acanthopanar gracilistμlusW.W.Smith的干燥根皮。味辛、苦,性温。有祛风湿,补益肝肾,强筋壮骨,利水消肿的作用。用于风湿痹病,筋骨痿软,小儿行迟,体虚乏力,水肿,脚气。
木瓜为蔷薇科植物贴梗海棠Chaenomeles speciosa(Sweet)Nakai的干燥近成熟果实。味酸,性温。有舒筋活络,和胃化湿的功效。用于治疗湿痹拘挛,腰膝关节酸重疼痛,暑湿吐泻,转筋挛痛,脚气水肿。
枳壳为芸香科植物酸橙Citrus aurantium L.及其栽培变种的干燥未成熟果实。味苦、辛、酸,性微寒。具有理气宽中,行滞消胀之功效。常用于胸胁气滞,胀满疼痛,食积不化,痰饮内停,脏器下垂。
柴胡为伞形科植物柴胡或狭叶柴胡的干燥根。味辛、苦,性微寒。具有和解表里,疏肝解郁,升阳举陷,退热截疟的功效。用于感冒发热,寒热往来,胸胁胀痛,月经不调,子宫脱垂,脱肛。
甘遂,为大戟科大戟属植物甘遂(学名:Euphorbia kansui T. N. Liou ex S. B.Ho)的块根,味苦寒有毒,具除水利尿、泻水逐肿,消肿散结功效;主治各种水肿;腹水;留饮结胸;癫痫;喘咳;大小便不通等。甘遂能刺激肠管,增加肠蠕动,产生泻下作用。生甘遂有较强的泻下作用,毒性亦较大,经醋炙后其泻下作用和毒性均有减低。甘遂中含有甘遂萜酯A、B有镇痛作用。甘遂对人体有利尿作用,亦有报道健康人口服甘遂煎剂亦无明显利尿。有实验表明,甘遂可明显减弱前列腺素E2的子宫收缩作用。
杜仲为杜仲科植物杜仲的树皮。甘微辛,温。补肝肾,强筋骨,安胎。治腰脊酸疼,足膝痿弱,小便余沥,阴下湿痒,胎漏欲堕,胎动不安,高血压。
由于采用上述技术方案,本发明较好的实现了发明目的,其工艺简单,药物组成相辅相成;采用低度黄酒控时浸泡药物,酒精含量低,服用顺口,病人易接受;药性温和,对胃肠刺激和肝肾损伤小;回流提取能有效提高组方药物的利用率和药效,药效作用与双氯芬酸钠相当,但副作用小,安全性更高;能显著改善急性软组织损伤所导致的皮下淤血与肌肉肿胀,具有十分良好的活血化瘀与消肿功效和抗炎作用。
具体实施方式
下面结合实施例对本发明作进一步说明。
实施例1:
一种跌打损伤酒剂,由以下配比原料制成:
归尾40g~60g,乳香80g~120g,红花40g~100g,赤芍40g~60g,牛膝40g~60g,细辛40g~60g,芝麻40g~60g,高良姜40g~60g,土鳖虫40g~60g,防风40g~60g,大血藤40g~60g,白芷40g~60g,羌活40g~60g,桔梗40g~60g,续断40g~60g,乌药40g~60g,槟榔40g~60g,陈皮40g~60g,生地黄40g~60g,没药0.010g~0.050g,龙胆草40g~60g,桃仁40g~60g,大黄40g~60g,三七40g~60g,茴香40g~60g,五加皮40g~60g,木瓜40g~60g,枳壳40g~60g,肉桂40g~60g,柴胡40g~60g,桂枝40g~60g,甘遂40g~60g,杜仲40g~60g,附子40g~60g,黄酒3kg~4kg(本实施例为归尾40g,乳香80g,红花40g,赤芍40g,牛膝40g,细辛40g,芝麻40g,高良姜40g,土鳖虫40g,防风45g,大血藤40g,白芷40g,羌活45g,桔梗40,续断40g,乌药40g,槟榔40g,陈皮40g,生地黄40g,没药0.015g,龙胆草45g,桃仁40g,大黄45g,三七55g,茴香45g,五加皮40g,木瓜40g,枳壳40g,肉桂45g,柴胡40g,桂枝45g,甘遂40g,杜仲40g,附子40g,黄酒3kg)。
本发明所述的附子为白附片。
如上述的一种跌打损伤酒剂的制备方法,包括以下步骤:
⑴分别将归尾、红花、赤芍、牛膝、细辛、芝麻、高良姜、土鳖虫、防风、大血藤、白芷、羌活、桔梗、续断、乌药、槟榔、陈皮、生地黄、龙胆草、桃仁、大黄、三七、茴香、五加皮、木瓜、枳壳、肉桂、柴胡、桂枝、甘遂、杜仲、附子进行粉粹后,按配比混合均匀,备用;
⑵将乳香、没药捣碎为小块;按配比混合均匀,备用;
⑶将步骤⑴、步骤⑵所得的备用混合药进行混合后装入可密封的容器内,按配比加入黄酒;
⑷热浸后,冷却,滤出药渣,密封静置,取上清液,既得。
本发明步骤⑴中所述的原料配比为归尾40g~60g,红花40g~100g,赤芍40g~60g,牛膝40g~60g,细辛40g~60g,芝麻40g~60g,高良姜40g~60g,土鳖虫40g~60g,防风40g~60g,大血藤40g~60g,白芷40g~60g,羌活40g~60g,桔梗40g~60g,续断40g~60g,乌药40g~60g,槟榔40g~60g,陈皮40g~60g,生地黄40g~60g,龙胆草40g~60g,桃仁40g~60g,大黄40g~60g,三七40g~60g,茴香40g~60g,五加皮40g~60g,木瓜40g~60g,枳壳40g~60g,肉桂40g~60g,柴胡40g~60g,桂枝40g~60g,甘遂40g~60g,杜仲40g~60g,附子40g~60g(本实施例为归尾40g,红花40g,赤芍40g,牛膝40g,细辛40g,芝麻40g,高良姜40g,土鳖虫40g,防风45g,大血藤40g,白芷40g,羌活45g,桔梗40,续断40g,乌药40g,槟榔40g,陈皮40g,生地黄40g,龙胆草45g,桃仁40g,大黄45g,三七55g,茴香45g,五加皮40g,木瓜40g,枳壳40g,肉桂45g,柴胡40g,桂枝45g,甘遂40g,杜仲40g,附子40g,黄酒3kg);
所述的步骤⑵中乳香、没药的配比为乳香80g~120g,没药0.010g~0.050g(本实施例为乳香80g,没药0.015g)。
本发明步骤⑴中所述的附子为白附片;所述的步骤⑶中的黄酒为8~20度(本实施例为20度)。
本发明步骤⑷中所述的热浸为加热提取,当液面沸腾出现泡沫时停止加热,冷却,滤出药渣;所述的静置时间为7天~10天(本实施例为10天),取上清液。
本发明所述的步骤⑷中密封容器的上方设有回流冷却器,所述的加热提取为采用回流提取法回流提取1小时~1.5小时(本实施例为1.5小时)使混合药和黄酒的混合物保持微沸。
实施例2:
本实施例中,一种跌打损伤酒剂,由以下配比原料制成:
归尾55g,乳香100g,红花60g,赤芍50g,牛膝50g,细辛40g,芝麻50g,高良姜50g,土鳖虫40g,防风40g,大血藤55g,白芷50g,羌活40g,桔梗50,续断40g,乌药45g,槟榔40g,陈皮55g,生地黄50g,没药0.020g,龙胆草40g,桃仁45g,大黄40g,三七40g,茴香40g,五加皮50g,木瓜55g,枳壳55g,肉桂40g,柴胡55g,桂枝40g,甘遂40g,杜仲55g,附子40g,黄酒3.5kg。
本实施例中,一种跌打损伤酒剂的制备方法,步骤⑴中所述的原料配比为归尾55g,红花60g,赤芍50g,牛膝50g,细辛40g,芝麻50g,高良姜50g,土鳖虫40g,防风40g,大血藤55g,白芷50g,羌活40g,桔梗50,续断40g,乌药45g,槟榔40g,陈皮55g,生地黄50g,龙胆草40g,桃仁45g,大黄40g,三七40g,茴香40g,五加皮50g,木瓜55g,枳壳55g,肉桂40g,柴胡55g,桂枝40g,甘遂40g,杜仲55g,附子40g,黄酒3.5kg;
所述的步骤⑵中乳香、没药的配比为乳香80g~120g,没药0.010g~0.050g(本实施例为乳香100g,没药0.020g)。
本发明步骤⑴中所述的附子为白附片;所述的步骤⑶中的黄酒为8~20度(本实施例为12度)。
本发明步骤⑷中所述的热浸为加热提取,当液面沸腾出现泡沫时停止加热,冷却,滤出药渣;所述的静置时间为7天~10天(本实施例为7天),取上清液。
本发明所述的步骤⑷中密封容器的上方设有回流冷却器,所述的加热提取为采用回流提取法回流提取1小时~1.5小时(本实施例为1小时)使混合药和黄酒的混合物保持微沸。
余同实施例1。
实施例3:
本实施例中,一种跌打损伤酒剂,由以下配比原料制成:
归尾50g,乳香100g,红花100g,赤芍50g,牛膝50g,细辛50g,芝麻50g,高良姜50g,土鳖虫50g,防风50g,大血藤50g,白芷50g,羌活50g,桔梗40,续断50g,乌药50g,槟榔50g,陈皮50g,生地黄50g,没药0.010g,龙胆草50g,桃仁50g,大黄50g,三七50g,茴香50g,五加皮50g,木瓜50g,枳壳50g,肉桂50g,柴胡50g,桂枝50g,甘遂50g,杜仲50g,附子50g,黄酒4kg。
本实施例中,一种跌打损伤酒剂的制备方法,步骤⑴中所述的原料配比为归尾50g,红花100g,赤芍50g,牛膝50g,细辛50g,芝麻50g,高良姜50g,土鳖虫50g,防风50g,大血藤50g,白芷50g,羌活50g,桔梗40,续断50g,乌药50g,槟榔50g,陈皮50g,生地黄50g,龙胆草50g,桃仁50g,大黄50g,三七50g,茴香50g,五加皮50g,木瓜50g,枳壳50g,肉桂50g,柴胡50g,桂枝50g,甘遂50g,杜仲50g,附子50g,黄酒4kg;
所述的步骤⑵中乳香、没药的配比为乳香80g~120g,没药0.010g~0.050g(本实施例为乳香100g,没药0.010g)。
本发明步骤⑴中所述的附子为白附片;所述的步骤⑶中的黄酒为8~20度(本实施例为12度)。
余同实施例2。
实施例4:
本实施例中,一种跌打损伤酒剂,由以下配比原料制成:
归尾60g,乳香120g,红花100g,赤芍60g,牛膝60g,细辛60g,芝麻60g,高良姜60g,土鳖虫60g,防风60g,大血藤60g,白芷60g,羌活60g,桔梗60,续断60g,乌药60g,槟榔60g,陈皮60g,生地黄60g,没药0.050g,龙胆草60g,桃仁60g,大黄60g,三七60g,茴香60g,五加皮60g,木瓜60g,枳壳60g,肉桂60g,柴胡60g,桂枝60g,甘遂50g,杜仲60g,附子60g,黄酒4kg。
本实施例中,一种跌打损伤酒剂的制备方法,步骤⑴中所述的原料配比为归尾60g,红花100g,赤芍60g,牛膝60g,细辛60g,芝麻60g,高良姜60g,土鳖虫60g,防风60g,大血藤60g,白芷60g,羌活60g,桔梗60,续断60g,乌药60g,槟榔60g,陈皮60g,生地黄60g,龙胆草60g,桃仁60g,大黄60g,三七60g,茴香60g,五加皮60g,木瓜60g,枳壳60g,肉桂60g,柴胡60g,桂枝60g,甘遂50g,杜仲60g,附子60g,黄酒4kg;
所述的步骤⑵中乳香、没药的配比为乳香80g~120g,没药0.010g~0.050g(本实施例为乳香120g,没药0.050g)。
本发明步骤⑴中所述的附子为白附片;所述的步骤⑶中的黄酒为8~20度(本实施例为8度)。
余同实施例3。
试验例
1材料
1.1动物
SD大鼠48只,雌雄各半体重(180±20)g,购自湖南天勤实验动物有限公司。在光/暗周期为12h/12h(光照时间7:00-19:00)的条件下饲养于笼中,自由获得饲料和饮水。实验动物许可证:SYKX(湘)2020-0008。
1.2药品与试剂
由湖南省中医药研究院中药研究所制剂室提供的生药粉采用实施例3配比制得(以下称:跌打损伤方),生产批号:20210826;
阳性对照组药,双氯芬酸纳缓释片,北京诺华制药有限公司,国药准字H10980297,批号20210127;
IL-1 ELISA 试剂盒,武汉博士德,批号:20210819;
IL-6 ELISA 试剂盒,武汉博士德,批号:20210819;
PGE2 ELISA 试剂盒,武汉博士德,批号:20210819。
1.3仪器
ME-202型电子天平;
Envision型酶标仪,(PE公司)。
2 实验方法
2.1动物模型的建、分组及给药
取SD大鼠48只,雌雄各半,体重(180±20g)称重后随机分成6组,每组8只,雌雄各半:
空白对照组(Blank)、模型对照组(Model)、阳性对照组(Positive controlmetformin 13.5mg•kg-1•d-1),
跌打损伤方低、中、高3个剂量组(Experimental-L 2.70 g•kg-1•d-1,Experimental-M 5.40 g•kg-1•d-1,Experimental-H 10.80 g•kg-1•d-1灌胃给药),
上述所有动物参照文献的方法采用10%硫化钠溶液脱除大鼠的小腿部鼠毛;
除空白对照组外,所有动物均采用自制撞击器,质量 160 g,固定高度,撞击接触面直径 0.8 cm 在大鼠小腿中部外侧连续打击 7 次,造成局部软组织挫伤模型。造模成功后开始给药,1次•d-1,连续7d;
模型对照组与空白对照组给予等体积蒸馏水。
2.2数据与标本采集
分别于1,4,7d观察大鼠损伤证候指数并分级评分,
评分方法:
皮下瘀血:多量块状计2分,少量点状计1分,无瘀血者计0分;
肌肉肿胀:明显肿胀计 2 分,稍有肿胀计1分,无肿胀者计 0 分;
皮肤颜色:紫暗色深计2分,暗红色浅计1分,色泽正常计 0 分。
试验结束后10%水合氯醛麻醉动物后,腹主动脉取血,3000r/15min离心后取血清,采用酶标仪,参照Elisa试剂盒的方法检测血清中IL-1、IL-6、PGE2水平。白介素1(IL-1),白介素6(IL-6)和前列腺素E2(PGE2)。
3 统计学处理
4结果
4.1本发明对急性软组织损伤大鼠模型体重的影响
空白对照组,模型对照组,阳性对照组,跌打损伤方低、中、高剂量组大鼠体重未见明显差异,结果见表1。
Compared with blank group,* P <0.05,** P <0.01;Compared with modelgroup,# P <0.05,## P <0.01
与空白对照组比较,模型对照组大鼠损伤证候指数在造模后1、4、7d均显著升高,差异有统计学意义(P<0.05或P<0.01);
与模型对照组比较,阳性对照组、跌打损伤方中、高剂量组在给药后4、7d损伤证候指数均显著降低,差异有统计学意义(P<0.05或P<0.01),结果见表2。
Compared with blank group,* P <0.05,** P <0.01;Compared with modelgroup,# P <0.05,## P <0.01
与空白对照组比较,模型对照组大鼠血清IL-1,IL-6,PGE2均显著升高,差异有统计学意义(P<0.01);与模型对照组比较,阳性对照组、跌打损伤方中、高剂量组大鼠血清IL-1,IL-6,PGE2均显著降低,差异有统计学意义(P<0.05或P<0.01),结果见表3。
Compared with blank group,* P <0.05,** P <0.01;Compared with modelgroup,# P <0.05,## P <0.01
5结论
本发明能显著改善急性软组织损伤所导致的皮下淤血与肌肉肿胀,具有较好的活血与消肿效果。空白对照组,模型对照组,阳性对照组,跌打损伤方低、中、高剂量组大鼠体重未见明显差异,说明本发明无明显的急性毒性。本发明能够显著降低急性软组织损伤大鼠模型血清中炎性因子IL-1,IL-6,PGE2水平,说明具有较强的抗炎作用,综上所述本发明具有活血、消肿、抗炎的功效。
Claims (10)
1.一种跌打损伤酒剂,其特征在于由以下配比原料制成:
归尾40g~60g,乳香80g~120g,红花40g~100g,赤芍40g~60g,牛膝40g~60g,细辛40g~60g,芝麻40g~60g,高良姜40g~60g,土鳖虫40g~60g,防风40g~60g,大血藤40g~60g,白芷40g~60g,羌活40g~60g,桔梗40g~60g,续断40g~60g,乌药40g~60g,槟榔40g~60g,陈皮40g~60g,生地黄40g~60g,没药0.010g~0.050g,龙胆草40g~60g,桃仁40g~60g,大黄40g~60g,三七40g~60g,茴香40g~60g,五加皮40g~60g,木瓜40g~60g,枳壳40g~60g,肉桂40g~60g,柴胡40g~60g,桂枝40g~60g,甘遂40g~60g,杜仲40g~60g,附子40g~60g,黄酒3kg~4kg。
2.根据权利要求1所述的一种跌打损伤酒剂,其特征在于由以下配比原料制成:归尾50g,乳香100g,红花100g,赤芍50g,牛膝50g,细辛50g,芝麻50g,高良姜50g,土鳖虫50g,防风50g,大血藤50g,白芷50g,羌活50g,桔梗40,续断50g,乌药50g,槟榔50g,陈皮50g,生地黄50g,没药0.010g,龙胆草50g,桃仁50g,大黄50g,三七50g,茴香50g,五加皮50g,木瓜50g,枳壳50g,肉桂50g,柴胡50g,桂枝50g,甘遂50g,杜仲50g,附子50g,黄酒4kg。
3.根据权利要求1或2所述的一种跌打损伤酒剂,其特征在于所述的附子为白附片。
4.一种跌打损伤酒剂的制备方法,其特征在于包括以下步骤:
⑴分别将归尾、红花、赤芍、牛膝、细辛、芝麻、高良姜、土鳖虫、防风、大血藤、白芷、羌活、桔梗、续断、乌药、槟榔、陈皮、生地黄、龙胆草、桃仁、大黄、三七、茴香、五加皮、木瓜、枳壳、肉桂、柴胡、桂枝、甘遂、杜仲、附子进行粉粹后,按配比混合均匀,备用;
⑵将乳香、没药捣碎为小块;按配比混合均匀,备用;
⑶将步骤⑴、步骤⑵所得的备用混合药进行混合后装入可密封的容器内,按配比加入黄酒;
⑷热浸后,冷却,滤出药渣,密封静置,取上清液,即得。
5.根据权利要求4所述的一种跌打损伤酒剂的制备方法,其特征在于步骤⑴中所述的原料配比为归尾40g~60g,红花40g~100g,赤芍40g~60g,牛膝40g~60g,细辛40g~60g,芝麻40g~60g,高良姜40g~60g,土鳖虫40g~60g,防风40g~60g,大血藤40g~60g,白芷40g~60g,羌活40g~60g,桔梗40g~60g,续断40g~60g,乌药40g~60g,槟榔40g~60g,陈皮40g~60g,生地黄40g~60g,龙胆草40g~60g,桃仁40g~60g,大黄40g~60g,三七40g~60g,茴香40g~60g,五加皮40g~60g,木瓜40g~60g,枳壳40g~60g,肉桂40g~60g,柴胡40g~60g,桂枝40g~60g,甘遂40g~60g,杜仲40g~60g,附子40g~60g;所述的步骤⑵中乳香、没药的配比为乳香80g~120g,没药0.010g~0.050g。
6.根据权利要求4或5所述的一种跌打损伤酒剂的制备方法,其特征在于步骤⑴中所述的附子为白附片;所述的步骤⑶中的黄酒为8~20度。
7.根据权利要求4或5所述的一种跌打损伤酒剂的制备方法,其特征在于步骤⑷中所述的热浸为加热提取,当液面沸腾出现泡沫时停止加热,冷却,滤出药渣;所述的静置时间为7天~10天,取上清液。
8.根据权利要求6所述的一种跌打损伤酒剂的制备方法,其特征在于步骤⑷中所述的热浸为加热提取,当液面沸腾出现泡沫时停止加热,冷却,滤出药渣;所述的静置时间为7天~10天,取上清液。
9.根据权利要求4或5所述的一种跌打损伤酒剂的制备方法,其特征在于所述的步骤⑷中密封容器的上方设有回流冷却器,所述的加热提取为回流提取。
10.根据权利要求8所述的一种跌打损伤酒剂的制备方法,其特征在于所述的步骤⑷中密封容器的上方设有回流冷却器,所述的加热提取为回流提取。
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