CN105456923A - 一种祛瘀止痛的中药组合物及其制备方法 - Google Patents
一种祛瘀止痛的中药组合物及其制备方法 Download PDFInfo
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- Medicines Containing Plant Substances (AREA)
Abstract
本发明涉及一种祛瘀止痛的中药组合物及其制备方法。该中药是由以下原料制备而成的:当归、栀子、生地、白芷、赤芍、白芥子、连翘、红花、黄柏、土鳖、昆布、白花蛇舌草、海藻、半枝莲、桃仁、水蛭、姜黄、土荆皮、鳖甲、蟾蜍、蜂房、阿魏、广丹、血竭、冰片。本发明还提供了这种中药组合物的制备方法。本发明提供的中药组合物具有祛瘀止痛、活血消肿、软坚散结之功,对跌打损伤、颈肩腰腿痛、乳腺增生疗效极佳。虽然治疗的病症不同,却可用同一药方,起到异病同治之功。
Description
技术领域
本发明涉及中药领域,具体涉及一种用于祛瘀止痛的中药组合物及其制备方法。
背景技术
中医治疗跌打损伤有着几千年的历史,古称“跌打损伤”为诸伤之总论,多因外力作用,或自身姿势不正确的情况下用力过猛而造成的。中医把凡因外力作用于人体而引起的筋骨伤损、瘀血肿痛、气血不和、经络不通以至脏器受损等,统称为跌打损伤。治疗宜以行气,散瘀,活血,止痛,舒筋,坚骨为主。
颈肩腰腿痛是临床常见多发病,也是疑难病,不仅给患者带来痛苦,也为骨伤、康复临床医生所棘手。引起颈肩腰腿痛的原因有很多,常见病包括:颈椎病,肩周炎,腱鞘炎,腰间盘突出,腰肌劳损,骨质增生等疾病。“肝主筋、肾主骨”;“痛则不通”;“湿邪留注则为痹”等都从某种角度阐述了颈肩腰腿痛形成的机理,治法多采用祛风除湿、祛瘀止痛、补肾壮骨。
乳腺增生病又称乳腺结构不良,是妇女最常见的乳腺疾病,既非炎症,也非肿瘤,是乳腺组织与间质不同程度的增生与复原所致的乳腺结构在数量上和形态上异常。在临床上主要表现为乳房肿块和乳痛。属中医“乳癖`、乳痞、乳中结核”等范畴。中医认为:乳癖其病位在肝脾肾,病属本虚标实。因七情所伤,气机不畅,致肝气郁结,肝郁脾虚,气滞痰凝,脉络不和,乳腺组织失却通畅,不通则见乳痛。肝气郁久,灼津为痰,气滞血瘀痰凝结聚成块,故见乳房肿块。“外科医案汇编”中曰:乳中结核,虽云肝病,其本在肾。阐明了肾和冲脉的关系更为密切。肾气不足,冲任失调,乳房胞宫必受累而发病。所以在临床上中医治疗多采用疏肝健脾、补肾调冲,辅以软坚散结、活血化瘀之法。
虽然这三种属于不同的病症,但是,祛瘀止痛的治疗思路却适用于这三种症状。
发明内容
本发明的目的是提供一种祛瘀止痛的中药组合物;
本发明的另一目的是提供一种祛瘀止痛的中药组合物的制备方法。
本发明的目的是通过下列的技术方案实现的:
本发明所述的祛瘀止痛的中药组合物,是由包括如下重量份的中药原料制备而成的:
当归80-250份、栀子80-250份、生地80-250份、白芷80-250份、赤芍80-250份、白芥子30-150份、连翘80-250份、红花30-150份、黄柏80-250份、土鳖30-150份、昆布30-150份、白花蛇舌草80-250份、海藻30-150份、半枝莲80-250份、桃仁80-250份、水蛭20-100份、姜黄30-150份、土荆皮80-250份、鳖甲50-200份、蟾蜍10-40份、蜂房20-100份。
它的活性成分是通过以下方法制备而成的:
方案一:取全部中药原料采用水提、麻油提取或40-80%体积百分浓度的乙醇提取制备而成。
方案二:将全部中药原料与相当于全部中药原料2-4倍量的麻油混合,加热20-60min,过滤,即得。
优选地,所述的祛瘀止痛的中药组合物,是由包括如下重量份的中药原料制备而成的::
组合物1:当归100-200份、栀子100-200份、生地100-200份、白芷100-200份、赤芍100-200份、白芥子50-120份、连翘100-200份、红花50-120份、黄柏100-200份、土鳖50-120份、昆布50-120份、白花蛇舌草100-200份、海藻50-120份、半枝莲100-200份、桃仁100-200份、水蛭40-70份、姜黄50-120份、土荆皮100-200份、鳖甲80-150份、蟾蜍10-40份、蜂房20-100份;
组合物2:阿魏80-150份、广丹3000-4000份。
它的活性成分是通过以下方法制备而成的:
方案三:(1)将组合物1中的全部中药原料与相当于组合物1的中药原料总重量2-4倍重量份的麻油混合,加热20-60min,过滤;
(2)步骤(1)中的滤液加热煮沸后,加入组合物2的全部中药原料,保温持续搅拌5-15min,即得。
方案四:取组合物1和组合物2混合后,加溶剂提取2-3次,每次加溶剂量相当于组合物1药材总重量的6-12倍,每次提取时间为1-3小时,合并提取液,滤过,滤液浓缩至70-80℃时相对密度为1.15-1.20的清膏,即得活性成分;所述的溶剂为水或者40-80%的乙醇。
更优的,所述的祛瘀止痛的中药组合物,是由包括如下重量份的中药原料制备而成的:当组合物1:归80-250份、栀子80-250份、生地80-250份、白芷80-250份、赤芍80-250份、白芥子30-150份、连翘80-250份、红花30-150份、黄柏80-250份、土鳖30-150份、昆布30-150份、白花蛇舌草80-250份、海藻30-150份、半枝莲80-250份、桃仁80-250份、水蛭20-100份、姜黄30-150份、土荆皮80-250份、鳖甲50-200份、蟾蜍10-40份、蜂房20-100份;
组合物2:阿魏50-200份、广丹2000-5000份;
组合物3:血竭40-70份、冰片100-200份。
它的活性成分是通过以下方法制备而成的:
方案五:(1)将组合物1中的全部中药原料与2-4倍重量份的麻油混合,加热20-60min,过滤;
(2)步骤(1)中的滤液加热煮沸后加入组合物2的全部中药原料,持续搅拌5-15min,停止加热;
(3)加入组合物3的中药原料,搅拌均匀,即得。
方案六:取组合物1和组合物2混合后,加溶剂提取2-3次,每次加溶剂量相当于组合物1药材总重量的6-12倍,每次提取时间为1-3小时,合并提取液,滤过,滤液浓缩至70-80℃时相对密度为1.15-1.20的清膏,取组合物3与清膏混合均匀,即得活性成分;
所述的溶剂为水或者40-80%的乙醇。以下是本发明中药制剂的药材来源:
当归,为伞形科植物当归Angelicasinensis(Oliv.)Diels的干燥根。【性味】甘、辛,温。【归经】归肝、心、脾经。【功能主治】补血活血,调经止痛,润肠通便。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。酒当归活血通经。用于经闭痛经,风湿痹痛,跌扑损伤。
栀子,为茜草科植物栀子GardeniajasminoidesEllis的干燥成熟果实。【性味】苦,寒。【归经】归心、肺、三焦经。【功能主治】果实:泻火除烦,清热利尿,凉血解毒。用于热病心烦,黄疸尿赤,血淋涩痛,血热吐衄,目赤肿痛,火毒疮疡;外治扭挫伤痛。
生地,为玄参科植物地黄RehmanniaglutinosaLibosch.的新鲜或干燥块根,缓缓烘焙至约八成干。【性味】甘,寒。【归经】归心、肝、肾经。【功能主治】生地黄:清热凉血,养阴,生津。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。
白芷,为伞型科植物白芷Angelicadahurica(Fisch.exHoffm.)Benth.etHook.f.或杭白芷Angelicadahurica(Fisch.exHoffm.)Benth.etHook.f.var.formosana(Boiss.)ShanetYuan的干燥根。【性味】辛,温。【归经】归胃、大肠、肺经。【功能主治】散风除湿,通窍止痛,消肿排脓。用于感冒头痛,眉棱骨痛,鼻塞,鼻渊,牙痛,白带,疮疡肿痛。
赤芍,为毛茛科植物芍药PaeonialactifloraPall.或川赤芍PaeoniaveitchiiLynch的干燥根。【性味】苦,微寒。【归经】归肝经。【功能主治】清热凉血,散瘀止痛。用于温毒发斑,吐血衄血,目赤肿痛,肝郁胁痛,经闭痛经,症瘕腹痛,跌扑损伤,痈肿疮疡。
白芥子,为十字花科植物白芥的种子。【性味】辛,温。【归经】入肺、胃经。【功能主治】利气豁痰,温中散寒,通络止痛。治痰饮咳喘,胸胁胀满疼痛,反胃呕吐,中风不语,肢体痹痛麻木,脚气,阴疽,肿毒,跌打肿痛。
连翘,为木犀科植物连翘Forsythiasuspensa(Thunb.)Vahl的干燥果实。【性味】苦,微寒。【归经】归肺、心、小肠经。【功能主治】清热解毒,消肿散结。用于痈疽,瘰疠,乳痈,丹毒,风热感冒,温病初起,温热入营,高热烦渴,神昏发斑,热淋尿闭。
红花,为菊科植物红花CarthamustinctoriusL.的干燥花。【性味】辛,温。【归经】归心、肝经。【功能主治】活血通经,散瘀止痛。用于经闭,痛经,恶露不行,症瘕痞块,跌扑损伤,疮疡肿痛。
黄柏,为芸香科植物黄皮树PhellodendronchinenseSchneid.或黄檗PhellodendronamurenseRupr.的干燥树皮。【性味】苦,寒。【归经】归肾、膀胱经。【功能主治】清热燥湿,泻火除蒸,解毒疗疮。用于湿热泻痢,黄疸,带下,热淋,脚气,痿{辟},骨蒸劳热,盗汗,遗精,疮疡肿毒,湿疹瘙痒。盐黄柏滋阴降火。用于阴虚火旺,盗汗骨蒸。
土鳖,为鳖蠊科昆虫地鳖EupolyphagasinensisWalker或冀地鳖Steleophagaplancyi(Boleny)的雌虫干燥体。【性味】咸,寒;有小毒。【归经】归肝经。【功能主治】破瘀血,续筋骨。用于筋骨折伤,瘀血经闭,症瘕痞块。
昆布,为海带科植物海带LaminariajaponicaAresch.或翅藻科植物昆布(鹅掌菜)EckloniakuromeOkam.的干燥叶状体。【性味】咸,寒。【归经】归肝、胃、肾经。【功能主治】,消痰,利水。用于瘿瘤,瘰疬,睾丸肿痛,痰饮水肿。
白花蛇舌草,为茜草科耳草属植物白花蛇舌草HedyotisdiffusaWilld.[Oldenlandiadiffusa(Willd.)Roxb.]的全草。【性味】甘、淡,凉。【归经】入胃、大肠、小肠经。【功能主治】清热解毒,利尿消肿,活血止痛。用于肠痈(阑尾炎),疮疖肿毒,湿热黄疸,小便不利等症;外用治疮疖痈肿,毒蛇咬伤。
海藻,为马尾藻科植物海蒿子Sargassumpallidum(Turn.)C.Ag.或羊栖菜Sargassumfusiforme(Harv.)Setch.的干燥藻体。【性味】苦、咸,寒。【归经】归肝、胃、肾经。【功能主治】软坚散结,消痰,利水。用于瘿瘤,瘰疬、睾丸肿痛,痰饮水肿。
半枝莲,为唇形科植物半枝莲ScutellariabarbataDon[S.rivularisWall]的干燥全草。【性味】辛、苦,寒。【归经】归肺、肝、肾经。【功能主治】清热解毒,化瘀利尿。用于疔疮肿毒,咽喉肿痛,毒蛇咬伤,跌扑伤痛,水肿,黄疸。
桃仁,为蔷薇科植物桃Prunuspersica(L.)Batsch或山桃Prunusdavidiana(Carr.)Franch.的干燥成熟种子。【性味】苦、甘,平。【归经】归心、肝、大肠经。【功能主治】活血祛瘀,润肠通便。用于经闭,痛经,癓瘕痞块,跌扑损伤,肠燥便秘。
水蛭,水蛭科动物蚂蟥WhitmaniapigraWhitman、水蛭HirudonipponicaWhitman或柳叶蚂蟥Whit-maniaacranulataWhitman的干燥体。【性味】咸、苦,平;有小毒。【归经】归肝经。【功能主治】破血,逐瘀,通经。用于症瘕痞块,血瘀经闭,跌扑损伤。
姜黄,为姜科植物姜黄CurcumalongaL.的干燥根茎。【性味】辛、苦,温。【归经】归脾、肝经。【功能主治】破血行气,通经止痛。用于胸胁剌痛,闭经,癓瘕,风湿肩臂疼痛,跌扑肿痛。
土荆皮,为松科植物金钱松PseudolarixkaempferiGord.的干燥根皮或近根树皮。【性味】辛,温;有毒。【归经】归肺、脾经。【功能主治】杀虫,止痒。用于疥癣瘙痒。
鳖甲,为鳖科动物鳖TrionyxsinensisWiegmann的背甲。【性味】咸,微寒。【归经】归肝、肾经。【功能主治】滋阴潜阳,软坚散结,退热除蒸。用于阴虚发热,劳热骨蒸,虚风内动,经闭,癓瘕,久疟疟母。
蟾蜍,为蟾蜍科动物中华大蟾蜍或黑眶蟾蜍等的全体。【性味】辛,凉,有毒。【归经】入心、肝、脾、肺四经。【功能主治】破症结,行水湿,化毒,杀虫,定痛。治疔疮,发背,阴疽瘰疬,恶疮,症瘕癖积,臌胀,水肿,小儿疳积,慢性气管炎。
蜂房,为胡蜂科昆虫果马蜂Polistesolivaceous(DeGeer)、日本长脚胡蜂PolistesjaponicusSaussure或异腹胡蜂ParapolybiavariaFabricius的巢。甘,平。归胃经。祛风,功毒,杀虫,止痛。用于龋齿牙痛,疮疡肿毒,乳痈,瘰疬,皮肤顽癣,鹅掌风。
阿魏,为伞形科植物新疆阿魏FerulasinkiangensisK.M.Shen或阜康阿魏FerulafukanensisK.M.Shen的树脂。【性味】苦、辛,温。【归经】归脾、胃经。【功能主治】消积,散痞,杀虫。用于肉食积滞,瘀血症瘕,腹中痞块,虫积腹痛。
广丹,为纯铅经加工制造而成的四氧化三铅(PB3O4)。【性味】辛、咸,微寒。有毒。【功能主治】拔毒生肌,敛疮。外用治疮疡肿毒,创伤出血,烧烫伤。
血竭,为棕榈科植物麒麟竭DaemonoropsdracoBlume.果实渗出的树脂经加工制成。【性味】甘、咸,平。【归经】归心、肝经。【功能主治】祛瘀定痛,止血生肌。用于跌扑折损,内伤瘀痛;外伤出血不止。
冰片,分机制冰片与艾片两类。机制冰片以松节油、樟脑等为原料经化学方法合成的龙脑;艾片为菊科艾纳香属植物大风艾的鲜叶经蒸气蒸馏、冷却所得的结晶,又称“艾粉”或“结片”。【性味】辛、苦,微寒。【归经】归心、脾、肺经。【功能主治】开窍醒神,清热止痛。用于热病神昏、痉厥,中风痰厥,气郁暴厥,中恶昏迷,目赤,口疮,咽喉肿痛,耳道流脓。
本发明所述的祛瘀止痛的中药组合物,可以与医药学上可接受的载体配合,制成各种常用制剂,如搽剂、洗剂、酊剂、凝胶剂、(软)膏剂、贴膏剂等。
本发明的药学上可接受的载体包括但不限于以下:
稀释剂:蒸馏水、乙醇等。
助溶剂:甘油、丙二醇、山梨醇等多元醇。
防腐剂:苯甲酸、苯甲酸钠、丙酸、尼泊金类、对羟基苯甲酸乙酯等。
油脂性基质:凡士林、液状石蜡、羊毛脂、蜂蜡、动物油、植物油、单硬脂酸甘油酯、十八醇等及其混合物、
水溶性基质:甘油、海藻酸钠、卡巴浦尔树脂、淀粉明胶、甲基纤维素、羧甲基纤维素钠、聚乙二醇、聚乙烯醇。
促透剂:角质保湿利尿素、吡咯酮类衍生物、亚油酸、月桂醇、吐温、十二烷基三甲基溴化铵、十二烷基磺酸钠、十二烷基硫酸钠、薄荷醇、月桂氮卓酮(氮酮)等。
例如,其可以通过下列方法之一制备为各种常见剂型:
方法1:搽剂
取方案一至方案六所得活性成分之一,加入搽剂常用辅料,按常规生产方法制备得本发明搽剂。
上述搽剂常用辅料包括稀释剂、防腐剂、助溶剂、促透剂之一或全部。
方法2:膏剂
取方案一至方案六所得活性成分之一,加入膏剂常用辅料,按常规生产方法制备得本发明膏剂。
上述膏剂常用辅料包括油脂性基质、水溶性基质、防腐剂、促透剂之一或全部。
方法3:贴膏
取方案一至方案六所得活性成分之一,与贴膏剂常用的基质和基材制成。
上述贴膏剂常用基材包括棉布、无纺布、纸、塑料薄膜、铝箔、聚乙烯复合膜、硬质纱布之一;常用基质包括油脂性基质、水溶性基质、防腐剂、促透剂之一或全部。
方法4:凝胶剂
取方案一至方案六所得活性成分之一,浓缩后与常用凝胶基质混合,按常规生产方法制备得本发明凝胶剂。
上述凝胶常用基质包括卡波姆、明胶、黄蓍胶、纤维素类和泊洛沙母等,还可加促透剂、助溶剂、稀释剂之一或全部。
方法4:粉剂
取全部药材碎成粗粉,过80-100目筛,即得本发明粉剂。
本申请人在研究传统中医辨证治疗的基础上参考现代药理研究成果,经过多年的试验,将多种配方进行筛选,找到了相互配合能很好祛瘀止痛的中药组合物。本发明配方合理创新,当归活血;栀子清热泻火解毒,至扭挫伤痛;生地凉血;白纸除湿止痛;赤芍散瘀止痛;白芥子通络止痛;连翘消肿散结;红花散瘀止痛;黄柏燥湿解毒;土鳖破瘀血,续筋骨;昆布软坚散结;白花蛇舌草解毒消肿、活血止痛;海藻软坚散结;半枝莲清热化瘀;桃仁活血祛瘀,治跌扑损伤;水蛭破血逐瘀;姜黄破血行气止痛;土荆皮杀虫止痒;鳖甲软坚散结;蟾蜍破症结,行水湿;阿魏散痞,治瘀血症瘕;广丹拔毒生肌;血竭祛瘀定痛;冰片清热止痛。以上诸药合用,具有祛瘀止痛、活血消肿、软坚散结之功,对跌打损伤、颈肩腰腿痛、乳腺增生疗效极佳。本发明技术方案符合中医辨证施治的机理,立足疾病之本源,组方合理科学,虽然治疗的病症不同,却可用同一药方,起到异病同治之功。
本发明提供的一种祛瘀止痛的中药组合物具有以下优点:
1、本发明提供的组合物安全有效,具有祛瘀止痛、活血消肿、软坚散结之功,对跌打损伤、颈肩腰腿痛、乳腺增生疗效极佳。虽然治疗的病症不同,却可用同一药方,起到异病同治之功。
2、本发明实施例2、3、8所述贴膏剂治疗跌打损伤的总有效率分别为85.7%、91.7%、96.7%,治疗颈肩腰腿痛的总有效率分别为84.6%、89.2%、96.6%,治疗乳腺增生的总有效率分别为83.6%、89.3%、96.0%,本发明中药组合物治疗跌打损伤、颈肩腰腿痛、乳腺增生疗效显著,其效果由组合物1、组合物1+组合物2、组合物1+组合物2+组合物3递增。
3、本发明中药组合物配方合理创新,生产成本低、工艺简单。
具体实施方式
下面通过实施例进一步说明本发明。应该理解的是,本发明的实施例是用于说明本发明而不是对本发明的限制。根据本发明的实质对本发明进行的简单改进都属于本发明要求保护的范围。除非另有说明,本发明中的乙醇量的百分数是体积百分数,v/v表示溶液的体积比。
实施例1搽剂
称取当归80g、栀子80g、生地80g、白芷80g、赤芍80g、白芥子30g、连翘80g、红花30g、黄柏80g、土鳖30g、昆布30g、白花蛇舌草80g、海藻30g、半枝莲80g、桃仁80g、水蛭20g、姜黄30g、土荆皮80g、鳖甲50g、蟾蜍10g、蜂房20g。用乙醇加热回流提取2次,每次乙醇浓度分别为80%、40%,每次乙醇用量分别为药材总量的10倍、8倍,提取时间分别为3小时、1小时,合并提取液,过滤,滤液回收乙醇,加入0.1%的苯甲酸钠、0.05%的尼泊金甲酯,混匀,分装,即得本发明搽剂。
实施例2贴膏剂
称取当归250g、栀子250g、生地250g、白芷250g、赤芍250g、白芥子150g、连翘250g、红花150g、黄柏250g、土鳖150g、昆布150g、白花蛇舌草250g、海藻150g、半枝莲250g、桃仁250g、水蛭100g、姜黄150g、土荆皮250g、鳖甲200g、蟾蜍40g、蜂房100g。将全部中药原料与相当于全部中药原料4倍量的麻油混合,加热60min,过滤滤液浓缩,与卡波姆基质混合,涂布于无纺布上制得贴膏剂。
实施例3贴膏剂
组合物1:当归80g、栀子80g、生地80g、白芷80g、赤芍80g、白芥子30g、连翘80g、红花30g、黄柏80g、土鳖30g、昆布30g、白花蛇舌草80g、海藻30g、半枝莲80g、桃仁80g、水蛭20g、姜黄30g、土荆皮80g、鳖甲50g、蟾蜍10g、蜂房20g;;
组合物2:阿魏50g、广丹2000g。
所述的祛瘀止痛的中药组合物,其贴膏剂是通过以下方法制备而成的:
(1)将组合物1中的全部中药原料与2倍重量份的麻油混合,加热20min,过滤;
(2)步骤(1)中的滤液加热煮沸后加入组合物2的全部中药原料,持续搅拌5min,停止加热,涂布于无纺布上制得贴膏剂。
实施例4凝胶剂
组合物1:当归250g、栀子250g、生地250g、白芷250g、赤芍250g、白芥子150g、连翘250g、红花150g、黄柏250g、土鳖150g、昆布150g、白花蛇舌草250g、海藻150g、半枝莲250g、桃仁250g、水蛭100g、姜黄150g、土荆皮250g、鳖甲200g、蟾蜍40g、蜂房100g;
组合物2:阿魏200g、广丹5000g。。
(1)将组合物1中的全部中药原料与相当于组合物1的中药原料总重量4倍重量份的麻油混合,加热60min,过滤;
(2)步骤(1)中的滤液加热煮沸后,加入组合物2的全部中药原料,保温持续搅拌15min,得活性成分,备用。
将卡波姆撒于适量的蒸馏水中,充分溶胀,加入丙二醇、月桂氮卓酮研磨使润湿,加三乙醇胺研磨成透明凝胶基质,水浴至70℃。取丙二醇、吐温-80混合加热溶解后,将上述活性成分加入到基质中,慢加快搅,加蒸馏水,继续搅拌均匀,得黄棕色透明凝胶剂。
实施例5凝胶剂
称取当归150g、栀子150g、生地150g、白芷150g、赤芍150g、白芥子80g、连翘150g、红花80g、黄柏150g、土鳖80g、昆布80g、白花蛇舌草150g、海藻80g、半枝莲150g、桃仁150g、水蛭50g、姜黄80g、土荆皮150g、鳖甲100g、蟾蜍20g、蜂房50g、广丹3500g。加水提取3次,三次加水量分别为药材总重量的12倍、8倍、6倍,合并提取液,滤过,滤液浓缩至80℃时相对密度为1.20的清膏,混匀,得活性成分备用。
将卡波姆撒于适量的蒸馏水中,充分溶胀,加入丙二醇、月桂氮卓酮研磨使润湿,加三乙醇胺研磨成透明凝胶基质,水浴至70℃。取丙二醇、吐温-80混合加热溶解后,将上述活性成分加入到基质中,慢加快搅,加蒸馏水,继续搅拌均匀,得黄棕色透明凝胶剂。
实施例6膏剂
称取当归130g、栀子180g、生地150g、白芷120g、赤芍130g、白芥子90g、连翘150g、红花80g、黄柏150g、土鳖100g、昆布90g、白花蛇舌草130g、海藻70g、半枝莲120g、桃仁180g、水蛭60g、姜黄80g、土荆皮160g、鳖甲100g、蟾蜍30g、蜂房60g、阿魏100g、广丹3200g、血竭70g、冰片150g。用乙醇回流提取3次,每次乙醇浓度分别为80%、60%、40%,每次乙醇用量分别为药材总量的12倍、8倍、6倍,提取时间分别为4小时、3小时、2小时,合并提取液,过滤,滤液浓缩至70℃时相对密度为1.15的浸膏,混匀,备用。
称取硬脂酸10g,凡士林95g,羊毛脂85g,硬脂酸甘油脂40g,十六醇80g,加热至85℃,搅匀,作为油相,备用;另取甘油120g,对羟基苯甲酸乙酯3g,十二烷基硫酸钠25g,月桂氮卓酮30g,加入上述加入蒸馏液的清膏,用水调节使油、水两相共1000g,作为水相,加热至90℃,待全部溶解后,恒温至85℃,搅匀;将油相缓缓加入水相,置匀浆机中搅拌,冷却,凝固,分装,即得本发明膏剂。
实施例7粉剂
称取当归180g、栀子120g、生地120g、白芷130g、赤芍130g、白芥子60g、连翘100g、红花90g、黄柏120g、土鳖90g、昆布90g、白花蛇舌草130g、海藻80g、半枝莲170g、桃仁180g、水蛭80g、姜黄60g、土荆皮170g、鳖甲80g、蟾蜍25g、蜂房80g、阿魏120g、广丹3800g、血竭40g、冰片90g。药材净选、粉碎,过80-100目筛,即得本发明粉剂。
实施例8贴膏剂
组合物1:当归80g、栀子80g、生地80g、白芷80g、赤芍80g、白芥子30g、连翘80g、红花30g、黄柏80g、土鳖30g、昆布30g、白花蛇舌草80g、海藻30g、半枝莲80g、桃仁80g、水蛭20g、姜黄30g、土荆皮80g、鳖甲50g、蟾蜍10g、蜂房20g;
组合物2:阿魏50g、广丹2000g;
组合物3:血竭40g、冰片100g。
(1)将组合物1中的全部中药原料与2倍重量份的麻油混合,加热20min,过滤;
(2)步骤(1)中的滤液加热煮沸后加入组合物2的全部中药原料,持续搅拌5min,停止加热;
(3)加入组合物3的中药原料,搅拌均匀,,与橡胶基质混合,涂布于硬质纱布上制得贴膏剂。
实施例9贴膏剂
组合物1:当归250g、栀子250g、生地250g、白芷250g、赤芍250g、白芥子150g、连翘250g、红花150g、黄柏250g、土鳖150g、昆布150g、白花蛇舌草250g、海藻150g、半枝莲250g、桃仁250g、水蛭100g、姜黄150g、土荆皮250g、鳖甲200g、蟾蜍40g、蜂房100g;
组合物2:阿魏200g、广丹5000g;
组合物3:血竭:70g、冰片200g。
去组合物1和组合物2混合,加水提取3次,每次加水量分别相当于药材总重量的12倍、10倍、6倍,每次提取时间为3小时、2小时、1小时,合并提取液,滤过,滤液浓缩至70℃时相对密度为1.20的清膏,取组合物3与清膏混合均匀,与橡胶基质混合,涂布于硬质纱布上制得贴膏剂。
临床试验总结
1.研究对象
观察223名患者,年龄在23-76岁之间,随机分成3组。
组1:73名患者,其中男27例,女46例;其中跌打损伤21例,颈肩腰腿痛39例,乳腺增生13例。
组2:75名患者,其中男30例,女45例,其中跌打损伤24例,颈肩腰腿痛37例,乳腺增生14例。
组2:75名患者,其中男26例,女49例,其中跌打损伤30例,颈肩腰腿痛29例,乳腺增生16例。
2.治疗方法:组1、组2、组3分别采用本发明实施例2、3、8所述贴膏剂贴敷患处,每贴使用12小时,1周为一个疗程,治疗2-3个疗程。
3.疗效标准
临床痊愈:跌打损伤患者疼痛基本消失,患处无肿胀、瘀斑,按压无疼痛感,日常生活不受影响;颈肩腰腿痛患者疼痛基本消失,疼痛部位无肿胀、瘀斑,日常生活不受影响;乳腺增生患者肿块消失,乳痛消失;
显效:跌打损伤患者疼痛明显减轻,偶发或有轻度疼痛,可以耐受,日常生活基本正常,颈肩腰腿痛患者疼痛明显减轻,疼痛部位偶发或有轻度疼痛;乳腺增生患者肿块缩小1/2以上,乳痛消失;
有效:跌打损伤患者患者的症状有一定程度好转,但仍有疼痛、肿胀、瘀斑,临床症状较治疗前减轻;颈肩腰腿痛患者症状有一定程度好转,但仍有疼痛、肿胀、瘀斑,临床症状较治疗前减轻乳腺增生患者肿块缩小1/3,乳痛减轻;
无效:治疗前后临床无明显改善,甚或加重。
4治疗结果治疗结果见表1-3:
表1:实施例2对三种疾病的的影响
例数 | 痊愈 | 显效 | 有效 | 无效 | 总有效率(%) | |
治疗跌打损伤 | 21 | 3 | 11 | 4 | 3 | 85.7 |
治疗颈肩腰腿痛 | 39 | 5 | 22 | 6 | 6 | 84.6 |
治疗乳腺增生 | 13 | 2 | 5 | 3 | 3 | 76.9 |
合计 | 73 | 10 | 38 | 13 | 12 | 83.6 |
表2:实施例3对三种疾病的的影响
例数 | 痊愈 | 显效 | 有效 | 无效 | 总有效率(%) | |
治疗跌打损伤 | 24 | 4 | 13 | 5 | 2 | 91.7 |
治疗颈肩腰腿痛 | 37 | 3 | 26 | 4 | 4 | 89.2 |
治疗乳腺增生 | 14 | 2 | 6 | 4 | 2 | 85.7 |
合计 | 75 | 9 | 45 | 13 | 8 | 89.3 |
表3:实施例8对三种疾病的的影响
例数 | 痊愈 | 显效 | 有效 | 无效 | 总有效率(%) | |
治疗跌打损伤 | 30 | 5 | 15 | 9 | 1 | 96.7 |
治疗颈肩腰腿痛 | 29 | 3 | 18 | 7 | 1 | 96.6 |
治疗乳腺增生 | 16 | 3 | 5 | 7 | 1 | 85.7 |
合计 | 75 | 11 | 38 | 23 | 3 | 96.0 |
由表1-3可知:本发明实施例2、3、8所述贴膏剂治疗跌打损伤的总有效率分别为85.7%、91.7%、96.7%,本发明实施例2、3、8所述贴膏剂治疗颈肩腰腿痛的总有效率分别为84.6%、89.2%、96.6%,本发明实施例2、3、8所述贴膏剂治疗乳腺增生的总有效率分别为83.6%、89.3%、96.0%,本发明中药组合物治疗跌打损伤、颈肩腰腿痛、乳腺增生疗效显著,其效果由组合物1、组合物1+组合物2、组合物1+组合物2+组合物3递增。
虽然,上文中已经用一般性说明、具体实施方式及试验,对本发明作了详尽的描述,但在本发明基础上,可以对之作一些修改或改进,这对本领域技术人员而言是显而易见的。因此,在不偏离本发明精神的基础上所做的这些修改或改进,均属于本发明要求保护的范围。
Claims (10)
1.一种祛瘀止痛的中药组合物,其特征在于它是由包括如下重量份的中药原料制备而成的:
当归80-250份、栀子80-250份、生地80-250份、白芷80-250份、赤芍80-250份、白芥子30-150份、连翘80-250份、红花30-150份、黄柏80-250份、土鳖30-150份、昆布30-150份、白花蛇舌草80-250份、海藻30-150份、半枝莲80-250份、桃仁80-250份、水蛭20-100份、姜黄30-150份、土荆皮80-250份、鳖甲50-200份、蟾蜍10-40份、蜂房20-100份。
2.如权利要求1所述的祛瘀止痛的中药组合物,其特征在于它的活性成分是通过以下方法制备而成的:取全部中药原料采用水提、麻油提取或40-80%体积百分浓度的乙醇提取制备而成。
3.如权利要求2所述的祛瘀止痛的中药组合物,其特征在于,它的活性成分是通过以下方法制备而成的:将全部中药原料与相当于全部中药原料2-4倍量的麻油混合,加热20-60min,过滤,即得。
4.一种祛瘀止痛的中药组合物,其特征在于它是由包括如下重量份的中药原料制备而成的:
组合物1:当归80-250份、栀子80-250份、生地80-250份、白芷80-250份、赤芍80-250份、白芥子30-150份、连翘80-250份、红花30-150份、黄柏80-250份、土鳖30-150份、昆布30-150份、白花蛇舌草80-250份、海藻30-150份、半枝莲80-250份、桃仁80-250份、水蛭20-100份、姜黄30-150份、土荆皮80-250份、鳖甲50-200份、蟾蜍10-40份、蜂房20-100份;
组合物2:阿魏50-200份、广丹2000-5000份。
5.如权利要求4所述的祛瘀止痛的中药组合物,其特征在于它的活性成分是通过以下方法制备而成的:(1)将组合物1中的全部中药原料与相当于组合物1的中药原料总重量2-4倍重量份的麻油混合,加热20-60min,过滤;
(2)步骤(1)中的滤液加热煮沸后,加入组合物2的全部中药原料,保温持续搅拌5-15min,即得。
6.如权利要求4所述的治祛瘀止痛的中药组合物,其特征在于它的活性成分是通过以下方法制备而成的:
取组合物1和组合物2混合后,加溶剂提取2-3次,每次加溶剂量相当于组合物1药材总重量的6-12倍,每次提取时间为1-3小时,合并提取液,滤过,滤液浓缩至70-80℃时相对密度为1.15-1.20的清膏,即得活性成分;所述的溶剂为水或者40-80%的乙醇。
7.一种祛瘀止痛的中药组合物,其特征在于它是由包括如下重量份的中药原料制备而成的:
当组合物1:归80-250份、栀子80-250份、生地80-250份、白芷80-250份、赤芍80-250份、白芥子30-150份、连翘80-250份、红花30-150份、黄柏80-250份、土鳖30-150份、昆布30-150份、白花蛇舌草80-250份、海藻30-150份、半枝莲80-250份、桃仁80-250份、水蛭20-100份、姜黄30-150份、土荆皮80-250份、鳖甲50-200份、蟾蜍10-40份、蜂房20-100份;
组合物2:阿魏50-200份、广丹2000-5000份;
组合物3:血竭40-70份、冰片100-200份。
8.如权利要求7所述的祛瘀止痛的中药组合物,其特征在于它的活性成分是通过以下方法制备而成的:
(1)将组合物1中的全部中药原料与2-4倍重量份的麻油混合,加热20-60min,过滤;
(2)步骤(1)中的滤液加热煮沸后加入组合物2的全部中药原料,持续搅拌5-15min,停止加热;
(3)加入组合物3的中药原料,搅拌均匀,即得。
9.如权利要求7所述的治祛瘀止痛的中药组合物,其特征在于它的活性成分是通过以下方法制备而成的:
取组合物1和组合物2混合后,加溶剂提取2-3次,每次加溶剂量相当于组合物1药材总重量的6-12倍,每次提取时间为1-3小时,合并提取液,滤过,滤液浓缩至70-80℃时相对密度为1.15-1.20的清膏,取组合物3与清膏混合均匀,即得活性成分;
所述的溶剂为水或者40-80%的乙醇。
10.一种祛瘀止痛的中药组合物,由权利要求1-9任何一项所述的祛瘀止痛的中药组合物与医药学上可接受的载体配合制备而成。
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