CN105727243A - 一种治疗心肌炎的中药组合物及其制备方法 - Google Patents
一种治疗心肌炎的中药组合物及其制备方法 Download PDFInfo
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- CN105727243A CN105727243A CN201610272822.4A CN201610272822A CN105727243A CN 105727243 A CN105727243 A CN 105727243A CN 201610272822 A CN201610272822 A CN 201610272822A CN 105727243 A CN105727243 A CN 105727243A
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Abstract
本发明涉及中医药领域,尤其涉及一种治疗心肌炎的中药组合物。由银杏叶、大枣、干姜、柴胡、甘草、金银花、蜈蚣、胆南星、黄芪、半夏、川芎、石菖蒲、麦冬、忍冬花、罗布麻、芦根、瓜萎、柏子仁、紫花地丁、半边莲、牡丹皮、雷公藤、冬葵子、地耳草、槟榔、泽兰、牛膝、斑蝥、昆布、桑白皮等组成。本发明相对于现有技术具有疗效好、成本低、局限性小、无不良反应等优点。与同类药物比较,本发明药物具有配伍严谨,药性平和,疗效显著的特点,便于在临床上大面积推广应用。
Description
技术领域
本发明属于中药学技术领域,具体涉及一种治疗心肌炎的中药组合物及其制备方法。
背景技术
心肌炎是指各种原因引起的心肌的炎症性病变。多种因素如感染、物理和化学因素均可引起心肌炎,所造成的心肌损害的轻重程度差别很大,临床表现各异,轻症患者无任何症状,而重症患者可发生心力衰竭、心源性休克甚至猝死。大部分患者经治疗可获得痊愈,有些患者在急性期之后发展为扩张型心肌病改变,可反复发生心力衰竭。
中医认为心肌炎属于心悸、怔忡、胸痹范畴,患者本虚表实、心失所养,心肌受损、脉气不续;主要症候群:心悸头晕,面色无华,倦怠无力,舌质淡,自汗和脉象细弱;主要由素体不足、外感温热毒邪、内侵心营、耗伤心阴或饮癖阻遏、内伤心阳而造成。目前用于治疗心肌炎的中、西医药物有很多,但由于生存环境的日益恶化、病毒的变异和耐药性的增强,心肌炎的治疗效果与以往相比大幅下降,患者复发率高。
发明内容
为了克服现有技术中的不足,本发明提供一种治疗心肌炎的中药组合物,对心肌炎具有显著疗效。
为了解决上述技术问题,本发明采用的技术方案如下:一种治疗心肌炎的中药组合物,由以下重量份数的各组分组成:
苦参0.5-3份、银杏叶2-13份、大枣2-25份、干姜1-4份、柴胡2-18份、甘草2-25份、金银花2-13份、蜈蚣0.5-3份、胆南星2-9份、黄芪1-7份、半夏1-6份、川芎3-8份、石菖蒲2-14份、麦冬2-16份、忍冬花1-18份、罗布麻1-13份、芦根1-5份、瓜萎3-14份、柏子仁1-10份、紫花地丁1-8份、半边莲1-6份、牡丹皮2-13份、雷公藤2-14份、冬葵子2-10份、地耳草1-7份、槟榔1-11份、泽兰2-14份、牛膝2-11份、斑蝥1-11份、昆布1-10份、桑白皮3-18份、山药5-19份、西洋参1-16份、大风子2-11份、女贞子3-18份、丹参2-10份、牛蒡子3-16份、墨旱莲2-18份、红花2-16份、远志1-3份、连翘1-4份、淡竹叶2-17份、枸杞子3-25份、白薇2-10份、茯苓1-7份、高良姜2-8份、香附1-4份、枇杷叶2-17份、败酱草1-3份、白芨1-4份。
进一步的,本发明由以下重量份数的各组分组成:
苦参0.5-1份、银杏叶2-10份、大枣2-15份、干姜1-4份、柴胡2-10份、甘草2-20份、金银花2-10份、蜈蚣0.5-3份、胆南星2-7份、黄芪1-5份、半夏1-6份、川芎3-5份、石菖蒲2-10份、麦冬2-10份、忍冬花1-10份、罗布麻1-10份、芦根1-5份、瓜萎3-10份、柏子仁1-10份、紫花地丁1-8份、半边莲1-6份、牡丹皮2-10份、雷公藤2-10份、冬葵子2-10份、地耳草1-7份、槟榔1-11份、泽兰2-10份、牛膝2-11份、斑蝥1-11份、昆布1-10份、桑白皮3-10份、山药5-10份、西洋参1-10份、大风子2-10份、女贞子3-10份、丹参2-10份、牛蒡子3-16份、墨旱莲2-10份、红花2-10份、远志1-3份、连翘1-4份、淡竹叶2-17份、枸杞子3-20份、白薇2-10份、茯苓1-7份、高良姜2-8份、香附1-4份、枇杷叶2-10份、败酱草1-3份、白芨1-4份。
进一步的,本发明由以下重量份数的各组分组成:
苦参0.5份、银杏叶8份、大枣7份、干姜1份、柴胡2份、甘草3份、金银花7份、蜈蚣0.5份、胆南星2份、黄芪2份、半夏2份、川芎3份、石菖蒲4份、麦冬3份、忍冬花4份、罗布麻5份、芦根2份、瓜萎4份、柏子仁3份、紫花地丁2份、半边莲3份、牡丹皮4份、雷公藤3份、冬葵子4份、地耳草4份、槟榔3份、泽兰4份、牛膝4份、斑蝥2份、昆布2份、桑白皮7份、山药7份、西洋参1份、大风子4份、女贞子3份、丹参2份、牛蒡子5份、墨旱莲3份、红花5份、远志1份、连翘2份、淡竹叶2份、枸杞子8份、白薇2份、茯苓5份、高良姜2份、香附3份、枇杷叶2份、败酱草1份、白芨1份。
进一步的,本发明由以下重量份数的各组分组成:苦参1份、银杏叶3份、大枣5份、干姜1份、柴胡3份、甘草3份、金银花4份、蜈蚣0.5份、胆南星3份、黄芪2份、半夏3份、川芎5份、石菖蒲6份、麦冬3份、忍冬花2份、罗布麻5份、芦根1份、瓜萎3份、柏子仁4份、紫花地丁3份、半边莲3份、牡丹皮2份、雷公藤2份、冬葵子2份、地耳草1份、槟榔3、泽兰4份、牛膝4份、斑蝥2份、昆布2份、桑白皮7份、山药7份、西洋参1份、大风子4份、女贞子3份、丹参2份、牛蒡子5份、墨旱莲3份、红花5份、远志1份、连翘2份、淡竹叶2份、枸杞子8份、白薇2份、茯苓5份、高良姜2份、香附3份、枇杷叶2份、败酱草1份、白芨1份。
进一步的,本发明所述中药制剂的剂型为:片剂、糖衣片剂、薄膜衣片剂、肠溶衣片剂、硬胶囊剂、软胶囊剂、口服液、***剂、颗粒剂、冲剂、蜜丸剂、散剂、丹剂、溶液剂、注射剂、栓剂、硬膏剂或糖浆剂。
为了解决上述技术问题,本发明还提供一种治疗心肌炎的中药组合物的制备方法,包括以下步骤:
(1)称取处方量的西洋参、苦参入不锈钢锅内,加常温下的水,加水量没过人参上层面1厘米,浸泡120分钟,加热150分钟,过滤制得一次过滤药液,并留渣,将所得一次过滤药液放在暂存容器内暂存;再向盛有药渣的锅中倒入开水,加开水量没过药渣上层面1厘米,加热10分钟,过滤得二次过滤药液,并去渣,将两次得到的过滤药液混合待用;
(2)按处方取银杏叶、大枣、干姜、柴胡、甘草、金银花、蜈蚣、胆南星、黄芪、半夏、川芎、石菖蒲、麦冬、忍冬花、罗布麻、芦根、瓜萎、柏子仁、紫花地丁、半边莲、牡丹皮、雷公藤、冬葵子、地耳草、槟榔、泽兰、牛膝、斑蝥、昆布、桑白皮、山药、大风子、女贞子、丹参、牛蒡子、墨旱莲、红花、远志、连翘、淡竹叶、枸杞子、白薇、茯苓、高良姜、香附、枇杷叶、败酱草、白芨放入不锈钢锅内,加常温下的水,加水量没过中药上层面1厘米,浸泡150分钟,加热10分钟,过滤制得一次过滤药液,并留渣,将所得一次过滤药液放在暂存容器内暂存;再向盛有药渣的锅中倒入开水,加开水量没过药渣上层面1厘米,加热10分钟,过滤得二次过滤药液,并去渣,将两次得到的过滤药液混合。
(3)在步骤(2)得到的过滤混合药液中加入步骤(1)中制备好的人参汤汁,并混合均匀,减压蒸馏,浓缩得到膏体,干燥粉碎得到粉末。
(4)步骤(3)所得粉末与药物辅料制得相应的制剂。
为了解决上述技术问题,本发明还提供另一种治疗心肌炎的中药组合物的制备方法,包括以下步骤:
包括以下步骤:取苦参、银杏叶、大枣、干姜、柴胡、甘草、金银花、蜈蚣、胆南星、黄芪、半夏、川芎、石菖蒲、麦冬、忍冬花、罗布麻、芦根、瓜萎、柏子仁、紫花地丁、半边莲、牡丹皮、雷公藤、冬葵子、地耳草、槟榔、泽兰、牛膝、斑蝥、昆布、桑白皮、山药、大风子、女贞子、丹参、牛蒡子、墨旱莲、红花、远志、连翘、淡竹叶、枸杞子、白薇、茯苓、高良姜、香附、枇杷叶、败酱草、白芨、西洋参药材洗净、烘干粉碎药材加水煎煮两次,第一次加水5-10倍量,煮沸1-5小时;第二次加水4-8倍量,煮沸0.5-3小时,合并煎液,过滤,将滤液于55℃浓缩至比重为1.14-1.47,放出浓缩液,加水稀释,静置24小时,取上清液过300-400目滤网,浓缩,加入氨基酸、甜菜碱等混合均匀等,然后按常规制剂工艺分别制成相应的胶囊剂、丸剂、片剂、散剂、口服液或颗粒剂。
本发明还包括治疗心肌炎的中药组合物或所述的中药组合物与药学上可接受的药物载体在制备治疗心肌炎的药物制剂中的应用。
本发明还包括所述的中药组合物或所述的中药组合物与药学上可接受的药物载体在制备治疗病毒性心肌炎、小儿心肌炎、肥大性心肌炎、中毒性心肌炎、扩张性心肌炎、细菌感染性心肌炎、病毒性心肌炎、慢性心肌炎的药物制剂中的应用。
本发明相对于现有技术具有疗效好、成本低、局限性小、无不良反应等优点。本发明是在传统的中医辩证施治的基础上结合临床实践研制而成,具有标本兼治、虚实并治、内外通调、缓急兼收,达到治疗心肌炎的目的。本发明药物根据辨病及辩证相结合的原则,与同类药物比较,具有配伍严谨,药性平和,疗效显著的特点,便于在临床上大面积推广应用。
具体实施方式
苦参:性味:苦,寒。归经:归心、肝、胃、大肠、膀胱经。功能主治:清热燥湿,杀虫,利尿。用于热痢,便血,黄疸尿闭,赤白带下,阴肿阴痒,湿疹,湿疮,皮肤瘙痒,疥癣麻风;外治滴虫性***炎。
银杏叶:性味:甘、苦、涩,平。归经:归心、肺经。功效:活血化瘀,通络止痛,敛肺平喘,化浊降脂。主治:用于瘀血阻络,胸痹心痛,中风偏瘫,肺虚咳喘,高脂血症。
大枣:性温、味甘,具益气补血、健脾和胃、袪风功效,对治疗过敏性紫癜、贫血、高血压、急慢性肝炎和肝硬化患者的血清转氨酶增高,以及预防输血反应等均有理想效果;大枣含有三萜类化合物及环磷酸腺苷,有较强的抑癌、抗过敏作用;枣中含有抗疲劳作用的物质,能增强人的耐力;枣还具有减轻毒性物质对肝脏损害的功效;枣中的黄酮类化合物,有镇静降血压的作用。
干姜:性味:辛、热。归经:归脾、胃、肾、心、肺经。功能主治:干姜温中散寒,回阳通脉,燥湿消痰。用于脘腹冷痛,呕吐泄泻,肢冷脉微,痰饮喘咳。
柴胡:为少阳经表药。主心腹肠胃中结气,饮食积聚,寒热邪气,推陈致新,除伤寒心下烦热者,足少阳胆也。胆为清净之府,无出无入,不可汗,不可吐,不可下,其经在半表半里,故法从和解,小柴胡汤之属是也。其性升而散,居阳,故能达表散邪也。邪结则心下烦热,邪散则烦热自解。阳气下陷,则为饮食积聚,阳升则清气上行,脾胃之气行阳道,则饮食积聚自消散矣。诸痰热结实,胸中邪逆,五脏间游气者,少阳实热之邪所生病也。柴胡苦平而微寒,能除热散结而解表,故能愈以上诸病。
甘草:性味:甘,平。归经:归心、肺、脾、胃经。功能主治:补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。用于脾胃虚弱,倦怠乏力,心悸气短,咳嗽痰多,脘腹、四肢挛急疼痛,痈肿疮毒,缓解药物毒性、烈性。
金银花:性味:甘,寒。归经:归肺、心、胃经。功能主治:清热解毒,凉散风热。用于痈肿疔疮,喉痹,丹毒,热毒血痢,风热感冒,温病发热。
蜈蚣:性味:辛,温;有毒。归经:归肝经。功效:息风镇痉,功毒散结,通络止痛。用于小儿惊风,抽搐痉挛,中风口歪,半身不遂,破伤风,风湿顽痹,疮疡,瘰疬,毒蛇咬伤。
胆南星:性味:①《本草正》:"味苦,性凉。"②《药品化义》:"味微辛而苦,性凉。"编辑:①《药品化义》:"入肝、胆。"②《本草再新》:"入心、肝、肺三经。"功用主治:清火化痰,镇惊定痼。治中风痰迷,惊风癫痫,痰火喘嗽,头风眩晕。
黄芪:性味:甘,温。归经:归肺、脾经。功能主治:补气固表,利尿托毒,排脓,敛疮生肌。用于气虚乏力,食少便溏,中气下陷,久泻脱肛,便血崩漏,表虚自汗,气虚水肿,痈疽难溃,久溃不敛,血虚痿黄,内热消渴;慢性肾炎蛋白尿,糖尿病。
半夏:性味:辛,温,有毒。①《本经》:"辛,平。"②《别录》:"生微寒,熟温,有毒。"③《药性论》:"有大毒。"④《日华子本草》:"味辛。"⑤(医学启源》:"《主治秘要》云,性温,味辛苦。归经:入脾、胃经。①《汤液本草》:"入足阳明、太阴、少阳经。"②《雷公炮制药性解》:"入肺、脾、胃三经。"③《本草经疏》:"入足太阴、阳明、少阳,手少阴经。"④《本草汇言》:"入手阳明、太阴、少阴三经。"⑤《本草再新》:"入肝、脾、肺三经。"功能主治:燥湿化痰,降逆止呕,消痞散结。治湿痰冷饮,呕吐,反胃,咳喘痰多,胸膈胀满,痰厥头痛,头晕不眠。外消痈肿。用于痰多咳喘、痰饮眩悸、内痰眩晕、呕吐反胃、胸脘痞闷、梅核气症;生用外治痈肿痰核。姜半夏多用于降逆止呕。
川芎:性味:辛,温。归经:归肝、胆、心包经。功能主治:活血行气,祛风止痛。用于***,经闭痛经,症瘕腹痛,胸胁刺痛,跌扑肿痛,头痛,风湿痹痛。
石菖蒲:性味:辛、苦,温。归经:归心、胃经。功能主治:化湿开胃,开窍豁痰,醒神益智。用于脘痞不饥,噤口下痢,神昏癫痫,健忘耳聋。
麦冬:味甘、微苦,性微寒,归胃、肺、心经,有养阴润肺、益胃生津、清心除烦的功效,用于肺燥干咳、阴虚痨嗽、喉痹咽痛、津伤口渴、内热消渴、心烦失眠、肠燥便秘等症。
忍冬花:性味:甘,寒。①《滇南本草》:"性寒,味苦。"②《本草正》:"味甘,气平,其性微寒。"归经:入肺、胃经。①《雷公炮制药性解》:"入肺经。"②《得配本草》:"入足阳明、太阴经。"功能主治:清热,解毒。治温病发热,热毒血痢,痈疡,肿毒,瘰疬,痔漏。①《滇南本草》:"清热,解诸疮,痈疽发背,丹流瘰疬。"②《生草药性备要》;"能消痈疽疔毒,止痢疾,洗疳疮,去皮肤血热。"
罗布麻:性味:甘苦,凉。①《陕西中草药》:"味淡涩,性凉,有小毒。"②《新疆中草药手册》:"味甘苦,性平,有小毒。"功能主治:清凉泻火,强心利尿,降血压。治心脏病,高血压,神经衰弱,肾炎浮肿。
芦根:性味:甘,寒。归经:归肺、胃经。功能主治:清热生津,除烦,止呕,利尿。用于热病烦渴,胃热呕哕,肺热咳嗽,肺痈吐脓,热淋涩痛。
瓜萎:性味:甘、微苦、寒。归经:归肺、胃、大肠经。功能主治:清热涤痰,宽胸散结,润燥滑肠。用于肺热咳嗽,痰浊黄稠,胸痹心痛,结胸痞满,乳痈,肺痈,肠痈肿痛,大便秘结。
柏子仁:性味:甘,平。归经:归心、肾、大肠经。功能主治:养心安神,止汗,润肠。用于虚烦失眠,心悸怔忡,阴虚盗汗,肠燥便秘。
紫花地丁:性味:苦、辛,寒。归经:归心、肝经。功能主治:清热解毒,凉血消肿。用于疔疮肿毒,痈疽发背,丹毒,毒蛇咬伤。
半边莲:性味:甘,平。①《纲目》:辛,平,无毒。②《生草药性备要》:味甜,性平。③《本草求原》:甘淡,平。归经:归心、小肠、肺经。
牡丹皮:性味:苦、辛,微寒。归经:归心、肝、肾经。功能主治:清热凉血,活血化瘀。用于温毒发斑,吐血衄血,夜热早凉,无汗骨蒸,经闭痛经,痈肿疮毒,跌扑伤痛。
雷公藤:性味:苦;辛;大毒。归经:心;肝经。功能主治:祛风除湿;活血通络;消肿止痛;杀虫解毒。主类风湿性关节炎;风湿性关节炎;肾小球肾炎;肾病综合征;红斑狼疮;口眼干燥综合征;白塞病;湿疹;银屑病;麻风病;疥疮;顽癣。
冬葵子:性味:甘;寒。归经:大肠;小肠;肝;肺;胃;膀胱经。功能主治:利水通淋;滑肠通便;下乳。主淋病;水肿;大便不通;乳汗不行。
地耳草:性味:甘、微苦,凉。功能主治:清热利湿,解毒消肿,散瘀止痛。用于肝炎,早期肝硬化,阑尾炎,眼结膜炎,扁桃体炎;外用治疮疖肿毒,带状疱疹,毒蛇咬伤,跌打损伤。
槟榔:性味:苦、辛,温。归经:归胃、大肠经。功能主治:杀虫消积,降气,行水,截疟。用于绦虫、蛔虫、姜片虫病,虫积腹痛,积滞泻痢,里急后重,水肿脚气,疟疾。
泽兰:性味:苦、辛,微温。归经:归肝、脾经。功能主治:活血化瘀,行水消肿。用于***,经闭,痛经,产后瘀血腹痛,水肿。
斑蝥:性味:辛,热;有大毒。归经:归肝、胃、肾经。功能主治:破血消癓,功毒蚀疮,引赤发泡。用于癓瘕肿块,积年顽癣,瘰疬,赘疣,痈疽不溃,恶疮死肌。
昆布:性味: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。
桑白皮:性味:甘,寒。归经:归肺经。功能主治:泻肺平喘,利水消肿。用于肺热喘咳,水肿胀满尿少,面目肌肤浮肿。
山药:性味:甘,平。归经:归脾、肺、肾经。功能主治:补脾养胃,生津益肺,补肾涩精。用于脾虚食少,久泻不止,肺虚喘咳,肾虚遗精,带下,尿频,虚热消渴。麸炒山药补脾健胃。用于脾虚食少,泄泻便溏,白带过多。
大风子:性味:味辛;性热;有毒。归经:肝;脾;肾经。功能主治:祛风燥湿;攻毒杀虫。主麻风;杨梅疮;疥癣;痤疮。
女贞子:性味:苦甘、平。①《本经》:"味苦,平。"②《别录》:"甘,无毒。"归经:入肝、肾经。①《本草经疏》:"入足少阴经。"②《本草再新》:"入肝、肺、肾三经。"功能主治:补肝肾,强腰膝。治阴虚内热,头晕,目花,耳鸣,腰膝酸软,须发早白。滋补肝肾,明目乌发。用于眩晕耳鸣,腰膝酸软、须发早白、目暗不明。
丹参:性味:苦,微寒。归经:归心、肝经。功能主治:祛瘀止痛,活血通经,清心除烦。用于***,经闭痛经,症瘕积聚,胸腹刺痛,热痹疼痛,疮疡肿痛,心烦不眠;肝脾肿大,心绞痛。
牛蒡子:性味:辛、苦,寒。归经:归肺、胃经。功能主治:疏散风热,宣肺透疹,解毒利咽。用于风热感冒,咳嗽痰多,麻疹,风疹,咽喉肿痛,痄腮丹毒,痈肿疮毒。
墨旱莲:性味:甘、酸,寒。归经:归肾、肝经。功能主治:滋补肝肾,凉血止血。用于牙齿松动,须发早白,眩晕耳鸣,腰膝酸软,阴虚血热、吐血、衄血、尿血,血痢,崩漏下血,外伤出血。
红花: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。
远志:性味:苦、辛、温。归经:归心、肾、肺经。功能主治:安神益智,祛痰,消肿。用于心肾不交引起的失眠多梦,健忘惊悸,神志恍惚,咳痰不爽,疮疡肿毒,***肿痛。
连翘:性味:苦,凉。①《本经》:"味苦,平。"②《别录》:"无毒。"③《医学启源》:"《主治秘诀》云,性凉,味苦。"④《纲目》:"微苦辛。"归经:入心、肝、胆经。①《汤液本草》:"手足少阳、阳明经。"②《纲目》:"少阴心经、厥阴包络气分。"③《雷公炮制药性解》:"入心、肝、胆、胃、三焦、大肠六经。"功能主治:清热,解毒,散结,消肿。治温热,丹毒,斑疹,痈疡肿毒,瘰疬,小便淋闭。①《本经》:"主寒热,鼠痿,瘰疬,痈肿恶疮,瘿瘤,结热。"②《别录》:"去白虫。"③《药性论》:"主通利五淋,小便不通,除心家客热。"④《日华子本草》:"通小肠,排脓。治疮疖,止痛,通月经。"⑤李杲:"散诸经血结气聚;消肿。"⑥王好古:"治耳聋浑浑焞焞。"
淡竹叶:味甘、淡,性寒。治肺热咳嗽,肺气上逆。治虚烦,发热不眠,退虚热,止烦热。煎点童便服。
枸杞子:性味:甘,平。归经:归肝、肾经。功能主治:滋补肝肾,益精明目。用于虚劳精亏,腰膝酸痛,眩晕耳鸣,内热消渴,血虚萎黄,目昏不明。
茯苓:性味:甘、淡,平。归经:归心、肺、脾、肾经。功能主治:利水渗湿,健脾宁心。用于水肿尿少,痰饮眩悸,脾虚食少,便溏泄泻,心神不安,惊悸失眠。
高良姜:性味:辛,热。归经:归脾、胃经。功能主治:温胃散寒,消食止痛。用于脘腹冷痛,胃寒呕吐,嗳气吞酸。
香附:性味:辛、微苦、微甘,平。归经:归肝、脾、三焦经。功能主治:行气解郁,调经止痛。用于肝郁气滞,胸、胁、脘腹胀痛,消化不良,胸脘痞闷,寒疝腹痛,***胀痛,***,经闭痛经。
枇杷叶:性味:苦,微寒。归经:归肺、胃经。功能主治:清肺止咳,降逆止呕。用于肺热咳嗽,气逆喘急,胃热呕逆,烦热口渴
败酱草:性味:辛、苦,凉。归经:入胃、大肠、肝经。功能主治:清热解毒,消痈排脓,活血行瘀。用于肠痈、肺痈及疮痈肿毒,实热瘀滞所致的胸腹疼痛,产后瘀滞腹痛等症。
白芨:别名:连及草、甘根、白给、箬兰、朱兰、紫兰、紫蕙、百笠。有收敛止血,消肿生肌的功效。用于咳血吐血,外伤出血,疮疡肿毒,皮肤皲裂;肺结核咳血,溃疡病出血。外感咳血,肺痈初起及肺胃有实热者忌服。
西洋参:性味:性凉,味甘、微苦。功能主治:补气养阴,清热生津。用于气虚阴亏,内热,咳喘痰血,虚热烦倦,消渴,口燥喉干。益肺阴,清虚火,生津止渴。治肺虚久嗽,失血,咽干口渴,虚热烦倦。
下面结合具体实施例对本发明做进一步阐述。
实施例1
将苦参1份、银杏叶3份、大枣5份、干姜1份、柴胡3份、甘草3份、金银花4份、蜈蚣0.5份、胆南星3份、黄芪2份、半夏3份、川芎5份、石菖蒲6份、麦冬3份、忍冬花2份、罗布麻5份、芦根1份、瓜萎3份、柏子仁4份、紫花地丁3份、半边莲3份、牡丹皮2份、雷公藤2份、冬葵子2份、地耳草1份、槟榔3、泽兰4份、牛膝4份、斑蝥2份、昆布2份、桑白皮7份、山药7份、西洋参1份、大风子4份、女贞子3份、丹参2份、牛蒡子5份、墨旱莲3份、红花5份、远志1份、连翘2份、淡竹叶2份、枸杞子8份、白薇2份、茯苓5份、高良姜2份、香附3份、枇杷叶2份、败酱草1份、白芨1份药材洗净、烘干粉碎药材加水煎煮两次,第一次加水5-10倍量,煮沸1-5小时;第二次加水4-8倍量,煮沸0.5-3小时,合并煎液,过滤,将滤液于55℃浓缩至比重为1.14-1.47,放出浓缩液,加水稀释,静置24小时,取上清液过300-400目滤网,浓缩,加入氨基酸、甜菜碱等混合均匀等,然后按常规制剂工艺分别制成相应的胶囊剂。
实施例2
苦参1份、银杏叶3份、大枣5份、干姜1份、柴胡3份、甘草3份、金银花4份、蜈蚣0.5份、胆南星3份、黄芪2份、半夏3份、川芎5份、石菖蒲6份、麦冬3份、忍冬花2份、罗布麻5份、芦根1份、瓜萎3份、柏子仁4份、紫花地丁3份、半边莲3份、牡丹皮2份、雷公藤2份、冬葵子2份、地耳草1份、槟榔3、泽兰4份、牛膝4份、斑蝥2份、昆布2份、桑白皮7份、山药7份、西洋参1份、大风子4份、女贞子3份、丹参2份、牛蒡子5份、墨旱莲3份、红花5份、远志1份、连翘2份、淡竹叶2份、枸杞子8份、白薇2份、茯苓5份、高良姜2份、香附3份、枇杷叶2份、败酱草1份、白芨1份,制备方法如下:
(1)称取处方量的西洋参、苦参入不锈钢锅内,加常温下的水,加水量没过人参上层面1厘米,浸泡120分钟,加热150分钟,过滤制得一次过滤药液,并留渣,将所得一次过滤药液放在暂存容器内暂存;再向盛有药渣的锅中倒入开水,加开水量没过药渣上层面1厘米,加热10分钟,过滤得二次过滤药液,并去渣,将两次得到的过滤药液混合待用;
(2)按处方取银杏叶、大枣、干姜、柴胡、甘草、金银花、蜈蚣、胆南星、黄芪、半夏、川芎、石菖蒲、麦冬、忍冬花、罗布麻、芦根、瓜萎、柏子仁、紫花地丁、半边莲、牡丹皮、雷公藤、冬葵子、地耳草、槟榔、泽兰、牛膝、斑蝥、昆布、桑白皮、山药、大风子、女贞子、丹参、牛蒡子、墨旱莲、红花、远志、连翘、淡竹叶、枸杞子、白薇、茯苓、高良姜、香附、枇杷叶、败酱草、白芨放入不锈钢锅内,加常温下的水,加水量没过中药上层面1厘米,浸泡150分钟,加热10分钟,过滤制得一次过滤药液,并留渣,将所得一次过滤药液放在暂存容器内暂存;再向盛有药渣的锅中倒入开水,加开水量没过药渣上层面1厘米,加热10分钟,过滤得二次过滤药液,并去渣,将两次得到的过滤药液混合。
(3)在步骤(2)得到的过滤混合药液中加入步骤(1)中制备好的人参汤汁,并混合均匀,减压蒸馏,浓缩得到膏体,干燥粉碎得到粉末。
(4)步骤(3)所得粉末与药物辅料制得相应的片剂。
实施例3
将苦参0.5份、银杏叶8份、大枣7份、干姜1份、柴胡2份、甘草3份、金银花7份、蜈蚣0.5份、胆南星2份、黄芪2份、半夏2份、川芎3份、石菖蒲4份、麦冬3份、忍冬花4份、罗布麻5份、芦根2份、瓜萎4份、柏子仁3份、紫花地丁2份、半边莲3份、牡丹皮4份、雷公藤3份、冬葵子4份、地耳草4份、槟榔3份、泽兰4份、牛膝4份、斑蝥2份、昆布2份、桑白皮7份、山药7份、西洋参1份、大风子4份、女贞子3份、丹参2份、牛蒡子5份、墨旱莲3份、红花5份、远志1份、连翘2份、淡竹叶2份、枸杞子8份、白薇2份、茯苓5份、高良姜2份、香附3份、枇杷叶2份、败酱草1份、白芨1份洗净、烘干粉碎药材加水煎煮两次,第一次加水5-10倍量,煮沸1-5小时;第二次加水4-8倍量,煮沸0.5-3小时,合并煎液,过滤,将滤液于55℃浓缩至比重为1.14-1.47,放出浓缩液,加水稀释,静置24小时,取上清液过300-400目滤网,浓缩,加入氨基酸、甜菜碱等混合均匀等,然后按常规制剂工艺分别制成相应的胶囊剂。
毒性试验:
实验动物
小白鼠由青岛市实验动物和动物实验中心提供。
小白鼠灌胃给药急性毒性实验
应用小鼠进行急性毒性实验表明:小鼠口服灌胃本发明的中药制剂胶囊剂,在387.1g生药/kg剂量下,给药后小鼠出现轻微活动减少,1小时左右恢复正常,给药后连续观察7天,无一动物死亡,其全身状况、饮食、摄水、小便和体重增长均正常,实验结果表明:小鼠口服灌胃本发明的中药制剂胶囊剂的最大给药量为388.8g生药/kg/d(LD50>388.8g生药/kg)。本发明的中药制剂每日临床用药总量为0.1g生药/kg/d;按体重计,小鼠灌胃本发明的中药制剂的耐受量为临床病人的3888倍。提示该药急性毒性低,临床用药安全。
大鼠灌胃给药长期毒性实验
毒性试验:
选用SD大鼠,给予不同浓度(16.0、5.0、1.0g生药/kg)的本发明的中药制剂片剂,每天灌胃一次,连续90天,末次给药后24小时各组活杀1/2动物(雌雄各半),其余1/2动物继续观察2周后活杀。试验期间观察动物的外观、一般行为、摄食量、体重变化,给药后90天和停药2周进行血液学(RBC、HB、网织红细胞、PLT、CT、WBC及分类)和血液生化(AST、ALT、ALP、Glu、BUN、Crea、TP、T.BIL、ALB、CHOL)、尿液生化、脏器系数、病理组织学等指标检查。试验结果表明:本发明的中药制剂在高、中、低剂量组动物一般状态良好,外观体征、行为活动、进食量和体重增长均无异常变化;三个剂量组及对照组血液学检查、血液生化学、尿液生化检查均在正常范围,组间无显著差异;各组主要脏器组织病理学检查未见明显异常。上述指标停药2周后也未见改变。本试验用药剂量分别为临床用药剂量的160、50、10倍,根据试验结果本发明的中药制剂在高、中、低三个剂量(16.0、5.0、1.0g生药/kg)连续90天给药对大鼠无明显影响,无明确的毒性靶器官和敏感指标,恢复期观察也未见延迟性毒性反应,提示本发明的中药制剂临床应用的剂量安全性较高。
临床资料。
(1)实验材料:
本发明人于2010年至今,对312例心肌炎患者进行临床观察治疗,其中,男153例,女159例。
(2)、诊断标准
诊断依据国家中医药管理局颁发的《中医病证诊断疗效标准》:上呼吸道感染、腹泻等病毒感染后1-3周内或急性期出现心脏表现(如舒张期奔马律,心包摩擦声,心脏扩大等)及充血性心力衰竭或心源性缺氧者。上述感染后1-3周内或发病同时新出现的各种心律失常而在未服用抗心律失常药物前出现下列心电图改变者:(1)房室或窦房传导阻滞、束支传导阻滞,(2)2个以上导联ST段有异常,呈水平或下斜型下移ST≥0.05mv,或多个导联ST异常抬高或有异常Q波者,(3)频发多形、多源成对或并行性早搏、短阵、阵发性室上性或室性心动过速、扑动或颤动等,(4)2个以上以R波为主波的导联T波倒置、平坦或降低为≥R波的1/10,(5)频发性房早或室早。具有以上(1)-(3)项中任意一项即可诊断,具有(4)或(5),或无明显病毒感染者要补充下列指标以助诊断:左室收缩功能减弱或病程早期有心肌酶增高。
(3)、治疗方法
服用实施例1的药物,每日1剂,每日2次,15天为1疗程。
(4)、治疗结果:
4.1参照《中医药新药临床研究指导原则》制定:
治愈:临床症状、体征消失,实验室各项指标检查恢复正常。
显效:临床症状、体征基本消失,心电图、血清酶基本恢复正常,其他有明显改善。
有效:临床症状、体征有所改善,实验室各项指标有一定改善。
无效:临床症状、体征及实验室各项指标均无改善。
4.2结果:312例患者中,治愈271例(86.86%),显效30例(9.62%),有效1例(0.32%),无效1例,总有效率为99.68%。
典型病例
病例1:胡某某,女,30岁。2010年10月就诊。自述两周前曾感冒,出现发热、咳嗽等症。经服药感冒症状缓解,但自觉胸闷、乏力,心悸,故来诊。经心电图检查结合临床症状诊为病毒性心肌炎。给予本方药服用一个月症状明显减轻,继服两个月诸症消失而痊愈。
病例2:王某某,男,20岁。一月前因胸闷、胸痛、乏力在中心医院诊为“病毒性心肌炎”,服药一个月不见好转,求治于中医。给予本方药服用一个月症状明显减轻,继服一个月诸症消失而痊愈。
病例3:姜某某,男,32。常感觉心悸胸闷,气短,自觉时有早搏,乏力,多梦,睡眠不实,少寐,舌淡红尖赤,苔白,脉促。心电图示:频发室早,二联律,心频示:偶发室早,心肌损伤,心肌缺血。诊断为病毒性心肌炎。服用本发明药物,治疗1个疗程,症状明显减轻,胸闷气短,纳食,睡眠好转,力气增加,继续服用2个疗程,痊愈,半年后随访无复发。
病例4,王某某,男,38岁,毒性心肌炎病史2年,时有气短,乏力。日前出现发热、咳嗽,继则出现心悸、胸闷、气短,乏力甚。舌暗红,苔白黄,脉滑律不齐。心电图示:频发室早,右束支不完全传导阻滞,心律不齐。服用本发明药物,每日1剂,1个疗程后,症状明显好转,发热、咳嗽消失,心悸、胸闷、气短减轻,时纳少。舌淡红,苔白,脉滑继续服用2个疗程,痊愈,一年后随访无复发。
以上所述,仅是本发明的最佳实施例而已,并非对本发明作任何形式上的限制,任何熟悉本领域的技术人员,在不脱离本发明技术方案范围情况下,利用上述揭示的方法内容对本发明技术方案做出许多可能的变动和修饰,均属于权利要求书保护的范围。
Claims (9)
1.一种治疗心肌炎的中药组合物,其特征在于:由以下各组分组成:苦参0.5-3份、银杏叶2-13份、大枣2-25份、干姜1-4份、柴胡2-18份、甘草2-25份、金银花2-13份、蜈蚣0.5-3份、胆南星2-9份、黄芪1-7份、半夏1-6份、川芎3-8份、石菖蒲2-14份、麦冬2-16份、忍冬花1-18份、罗布麻1-13份、芦根1-5份、瓜萎3-14份、柏子仁1-10份、紫花地丁1-8份、半边莲1-6份、牡丹皮2-13份、雷公藤2-14份、冬葵子2-10份、地耳草1-7份、槟榔1-11份、泽兰2-14份、牛膝2-11份、斑蝥1-11份、昆布1-10份、桑白皮3-18份、山药5-19份、西洋参1-16份、大风子2-11份、女贞子3-18份、丹参2-10份、牛蒡子3-16份、墨旱莲2-18份、红花2-16份、远志1-3份、连翘1-4份、淡竹叶2-17份、枸杞子3-25份、白薇2-10份、茯苓1-7份、高良姜2-8份、香附1-4份、枇杷叶2-17份、败酱草1-3份、白芨1-4份。
2.根据权利要求1所述的一种治疗心肌炎的中药组合物,其特征在于:由以下重量份数的各组分组成:
苦参0.5-1份、银杏叶2-10份、大枣2-15份、干姜1-4份、柴胡2-10份、甘草2-20份、金银花2-10份、蜈蚣0.5-3份、胆南星2-7份、黄芪1-5份、半夏1-6份、川芎3-5份、石菖蒲2-10份、麦冬2-10份、忍冬花1-10份、罗布麻1-10份、芦根1-5份、瓜萎3-10份、柏子仁1-10份、紫花地丁1-8份、半边莲1-6份、牡丹皮2-10份、雷公藤2-10份、冬葵子2-10份、地耳草1-7份、槟榔1-11份、泽兰2-10份、牛膝2-11份、斑蝥1-11份、昆布1-10份、桑白皮3-10份、山药5-10份、西洋参1-10份、大风子2-10份、女贞子3-10份、丹参2-10份、牛蒡子3-16份、墨旱莲2-10份、红花2-10份、远志1-3份、连翘1-4份、淡竹叶2-17份、枸杞子3-20份、白薇2-10份、茯苓1-7份、高良姜2-8份、香附1-4份、枇杷叶2-10份、败酱草1-3份、白芨1-4份。
3.根据权利要求1至2所述的一种治疗心肌炎的中药组合物,其特征在于:由以下重量份数的各组分组成:苦参0.5份、银杏叶8份、大枣7份、干姜1份、柴胡2份、甘草3份、金银花7份、蜈蚣0.5份、胆南星2份、黄芪2份、半夏2份、川芎3份、石菖蒲4份、麦冬3份、忍冬花4份、罗布麻5份、芦根2份、瓜萎4份、柏子仁3份、紫花地丁2份、半边莲3份、牡丹皮4份、雷公藤3份、冬葵子4份、地耳草4份、槟榔3份、泽兰4份、牛膝4份、斑蝥2份、昆布2份、桑白皮7份、山药7份、西洋参1份、大风子4份、女贞子3份、丹参2份、牛蒡子5份、墨旱莲3份、红花5份、远志1份、连翘2份、淡竹叶2份、枸杞子8份、白薇2份、茯苓5份、高良姜2份、香附3份、枇杷叶2份、败酱草1份、白芨1份。
4.根据权利要求1至3所述的一种治疗心肌炎的中药组合物,其特征在于:由以下重量份数的各组分组成:苦参1份、银杏叶3份、大枣5份、干姜1份、柴胡3份、甘草3份、金银花4份、蜈蚣0.5份、胆南星3份、黄芪2份、半夏3份、川芎5份、石菖蒲6份、麦冬3份、忍冬花2份、罗布麻5份、芦根1份、瓜萎3份、柏子仁4份、紫花地丁3份、半边莲3份、牡丹皮2份、雷公藤2份、冬葵子2份、地耳草1份、槟榔3、泽兰4份、牛膝4份、斑蝥2份、昆布2份、桑白皮7份、山药7份、西洋参1份、大风子4份、女贞子3份、丹参2份、牛蒡子5份、墨旱莲3份、红花5份、远志1份、连翘2份、淡竹叶2份、枸杞子8份、白薇2份、茯苓5份、高良姜2份、香附3份、枇杷叶2份、败酱草1份、白芨1份。
5.根据权利要求1至4所述的一种治疗心肌炎的中药组合物,其特征在于:所述中药制剂的剂型为:片剂、糖衣片剂、薄膜衣片剂、肠溶衣片剂、硬胶囊剂、软胶囊剂、口服液、***剂、颗粒剂、冲剂、蜜丸剂、散剂、丹剂、溶液剂、注射剂、栓剂、硬膏剂或糖浆剂。
6.根据权利要求1至5所述的一种治疗心肌炎的中药组合物的制备方法,其特征在于:包括以下步骤:
(1)称取处方量的西洋参、苦参入不锈钢锅内,加常温下的水,加水量没过人参上层面1厘米,浸泡120分钟,加热150分钟,过滤制得一次过滤药液,并留渣,将所得一次过滤药液放在暂存容器内暂存;再向盛有药渣的锅中倒入开水,加开水量没过药渣上层面1厘米,加热10分钟,过滤得二次过滤药液,并去渣,将两次得到的过滤药液混合待用;
(2)按处方取银杏叶、大枣、干姜、柴胡、甘草、金银花、蜈蚣、胆南星、黄芪、半夏、川芎、石菖蒲、麦冬、忍冬花、罗布麻、芦根、瓜萎、柏子仁、紫花地丁、半边莲、牡丹皮、雷公藤、冬葵子、地耳草、槟榔、泽兰、牛膝、斑蝥、昆布、桑白皮、山药、大风子、女贞子、丹参、牛蒡子、墨旱莲、红花、远志、连翘、淡竹叶、枸杞子、白薇、茯苓、高良姜、香附、枇杷叶、败酱草、白芨放入不锈钢锅内,加常温下的水,加水量没过中药上层面1厘米,浸泡150分钟,加热10分钟,过滤制得一次过滤药液,并留渣,将所得一次过滤药液放在暂存容器内暂存;再向盛有药渣的锅中倒入开水,加开水量没过药渣上层面1厘米,加热10分钟,过滤得二次过滤药液,并去渣,将两次得到的过滤药液混合。
(3)在步骤(2)得到的过滤混合药液中加入步骤(1)中制备好的人参汤汁,并混合均匀,减压蒸馏,浓缩得到膏体,干燥粉碎得到粉末。
(4)步骤(3)所得粉末与药物辅料制得相应的制剂。
7.根据权利要求6所述的一种治疗心肌炎的中药组合物的制备方法,其特征在于:包括以下步骤:取苦参、银杏叶、大枣、干姜、柴胡、甘草、金银花、蜈蚣、胆南星、黄芪、半夏、川芎、石菖蒲、麦冬、忍冬花、罗布麻、芦根、瓜萎、柏子仁、紫花地丁、半边莲、牡丹皮、雷公藤、冬葵子、地耳草、槟榔、泽兰、牛膝、斑蝥、昆布、桑白皮、山药、大风子、女贞子、丹参、牛蒡子、墨旱莲、红花、远志、连翘、淡竹叶、枸杞子、白薇、茯苓、高良姜、香附、枇杷叶、败酱草、白芨、西洋参药材洗净、烘干粉碎药材加水煎煮两次,第一次加水5-10倍量,煮沸1-5小时;第二次加水4-8倍量,煮沸0.5-3小时,合并煎液,过滤,将滤液于55℃浓缩至比重为1.14-1.47,放出浓缩液,加水稀释,静置24小时,取上清液过300-400目滤网,浓缩,加入氨基酸、甜菜碱等混合均匀等,然后按常规制剂工艺分别制成相应的胶囊剂、丸剂、片剂、散剂、口服液或颗粒剂。
8.根据权利要求1所述的治疗心肌炎的中药组合物或所述的中药组合物与药学上可接受的药物载体在制备治疗心肌炎的药物制剂中的应用。
9.根据权利要求8所述的应用,其特征在于,所述的中药组合物或所述的中药组合物与药学上可接受的药物载体在制备治疗病毒性心肌炎、小儿心肌炎、肥大性心肌炎、中毒性心肌炎、扩张性心肌炎、细菌感染性心肌炎、病毒性心肌炎、慢性心肌炎的药物制剂中的应用。
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