CN115089676A - 一种含青叶胆的中药复方组合物在制备治疗冠心病二级预防药物中的应用 - Google Patents
一种含青叶胆的中药复方组合物在制备治疗冠心病二级预防药物中的应用 Download PDFInfo
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Abstract
本发明属于一种具有化湿宽胸、清肝息风功效的中药复方组合物及在冠心病治疗中的应用领域。本发明采用的技术方案为一种含青叶胆的中药复方组合物在制备预防和辅助治疗冠心病二级药物中的应用,该中药组合物按照质量份数包括以下组分:青叶胆500~4000份,瓜蒌皮500~4000份,天麻2000~8000份,党参2000~8000份,白术500~4000份,苍术500~3000份,香附500~3000份,炒栀子500~3000份,山萸肉500~3000份,莲子心300~2000份,陈皮500~3000份,茯苓1000~8000份,荷叶1000~4000份,桑叶1000~4000份,红景天1000~4000份,银杏叶2000~8000份,枳实500~2000份,厚朴500~2000份,龟板1000~4000份,砂仁300~2000份,僵蚕500~3000份,桔梗500~2000份。更进一步,将前述混合物通过特定的制备方法得到的提取物,与药学上可接受的载体制备成膏剂、口服液、颗粒剂、胶囊剂、片剂或滴丸剂型的药物。
Description
技术领域
本发明属于中药复方组合物,具体地说,是涉及一种具有化湿宽胸、清肝息风功效的中药复方组合物及在冠心病治疗中的应用。
背景技术
上世纪80~90年代,经皮冠状动脉腔内成形术(PTCA) 被证实是冠心病治疗的有效方法,但PTCA术后约30%的患者发生再狭窄(RS); 90年代后,冠脉内支架植入被广泛用于冠心病治疗,但术后也仍有15%~35%的再狭窄发生率,成为影响其疗效的关键问题。在我国心血管疾病诊疗实践中,中医药及中西医结合得到广泛应用,具有自身特点,并有确切疗效,在缓解心绞痛、预防冠状动脉介入术后再狭窄、防治再灌注后无复流、心肌梗死二级预防等方面具有一定优势。但学界对冠心病病机认识的纷杂、治法制定的随意、组方遣药的多变,对自身在冠心病诊治中的科学定位和优势切入点欠明晰,继承不够而创新不足等问题,依然制约中医药在高血压治疗中的科学应用和疗效提高,无法完全体现中医药在冠心病早期预防、增效减副、远期器官保护中的“比较优势”。冠心病归属于中医“胸痹心痛”范畴,张仲景在《金匮要略》中将胸痹心痛病机精炼总结为“阳微阴弦”,阴寒之邪乘虚僭居胸阳之位,造成胸中阳气闭塞,脉络痹阻,卒发胸痹心痛。目前中医学界对冠心病的二级预防多参照西医抗血小板聚集的思路而应用活血化瘀之法,具有一定局限性,并不能全面概括冠心病发生、发作的中医病机。
发明内容
发明目的
基于提出的冠心病“湿盛风引”病机理论,针对冠心病中医二级预防的难点,提供一种用于冠心病二级预防和辅助治疗,具有化湿宽胸、清肝息风功效的中药复方组合物及其制备方法。
采用的技术方案
一种含青叶胆的中药复方组合物在制备预防和辅助治疗冠心病二级药物中的应用,该中药组合物按照质量份数包括以下组分:青叶胆500~4000份,瓜蒌皮 500~4000份,天麻2000~8000份,党参2000~8000份,白术500~4000份,苍术 500~3000份,香附500~3000份,炒栀子500~3000份,山萸肉500~3000份,莲子心300~2000份,陈皮500~3000份,茯苓1000~8000份,荷叶1000~4000份,桑叶1000~4000份,红景天1000~4000份,银杏叶2000~8000份,枳实500~2000 份,厚朴500~2000份,龟板1000~4000份,砂仁300~2000份,僵蚕500~3000 份,桔梗500~2000份。
进一步,该中药组合物的质量份数为:青叶胆1000~2000份,瓜蒌皮 2000~3000份,天麻3000~6000份,党参3000~6000份,白术1000~3000份,苍术1000~2000份,香附1000~2000份,炒栀子1000~2000份,山萸肉1000~2000 份,莲子心500~1500份,陈皮1000~2000份,茯苓2000~6000份,荷叶2000~3000 份,桑叶2000~3000份,红景天2000~3000份,银杏叶3000~6000份,枳实 1000~1500份,厚朴1000~1500份,龟板2000~3000份,砂仁600~1000份,僵蚕1000~2000份,桔梗1000~1500份。
进一步,该中药复方组合物的制备方法包括以下方法步骤:(1)按以上所述的质量份数取青叶胆、瓜蒌皮、天麻、党参、白术、苍术、香附、炒栀子、山萸肉、莲子心、陈皮、茯苓、荷叶、桑叶、红景天、银杏叶、枳实、厚朴、龟板、砂仁、僵蚕、桔梗饮片,加水煎煮二次,每次1~2小时,合并煎液,滤过,浓缩滤液,加入体积浓度为85%乙醇进行醇沉处理,滤去沉淀物,滤液回收并80℃浓缩至相对密度1.30~1.36,得浸膏;(2)取前步骤得到的浸膏,与药学上可接受的载体制备成膏剂、口服液、颗粒剂、胶囊剂、片剂或滴丸剂型的药物。
有益效果
本发明用于冠心病二级预防和辅助治疗的中药复方组合物,针对胸中阳气不振,脾虚生湿,肝肾亏虚生风,内风引动痰湿伏邪而上乘阳位痹阻胸中气机发为胸闷或胸痛或气短的胸痹心痛(冠心病)“湿盛风引”病机,基于“治痹必治湿,湿去胸阳驰;治痹必治风,风宁痹自通”的论治思路,以及“健脾疏肝益肾以绝湿生之源、燥湿利湿化湿以袪已生之湿”治湿之法和“补肝益肾健脾以袪生风之基、平肝清肝镇潜以消风火之象、酌用风药以胜湿清旷胸阳”治风之术而拟立。方中青叶胆清肝利湿,瓜蒌皮化痰利气宽胸,为肝火化风上炎引动痰湿蒙蔽胸阳主病机而设,共为君药。天麻平抑肝阳,息风通络,以助平肝清肝之力;党参补中益气,白术健脾益气、燥湿止汗,苍术燥湿健脾、祛风,三药共奏健脾燥湿之功,以绝湿源;龟板滋肾潜阳,使肝阳有根,以绝生风之源;以上诸药奏潜阳息风、健脾祛湿之功,共为臣药。佐以香附、厚朴、枳实疏肝解郁、理气宽中,炒栀子清肝泻火,山萸肉补益肝肾,莲子心清泻心火,陈皮、茯苓、荷叶祛湿化痰,桑叶凉血祛湿息风,僵蚕息风通络,红景天、银杏叶活血化瘀,砂仁化湿开胃。桔梗为使,载药上行、宣开肺气、以利痰湿消散。诸药合用,共奏健脾化湿,平肝益肾,息风通络而振奋胸阳、宽胸利气、宣痹止痛之功。
本发明的中药复方组合物用于冠心病的二级预防和辅助治疗能明显降低患者心绞痛的发作次数,能明显改善冠心病脾虚湿蕴、肝肾亏虚证患者胸闷或胸痛或气短、多汗、口干、口粘或口苦、头晕目眩、疲乏困倦、耳鸣健忘、失眠多梦、腰膝酸软、视物昏花、心烦易怒、便溏等临床症状,治疗冠心病(脾虚湿蕴、肝肾亏虚证)疗效肯定,并且长期服用毒副作用小,用药安全可靠。
具体实施例
用于冠心病脾虚湿蕴、肝肾亏虚证的二级预防和辅助治疗,临床表现为胸闷或胸痛或气短,阴雨天或情绪激动或情志不舒易发作,超重或形体肥胖,多汗,口干、口粘或口苦,头晕目眩,疲乏困倦,耳鸣健忘,失眠多梦,腰膝酸软,视物昏花,或五心烦热,或心烦易怒,或不寐,或易生湿疹,或便溏,舌体胖大边有齿痕或舌红,苔腻或薄黄腻,脉弦或数或细或濡等。
按质量份数包括以下中药饮片成分:青叶胆10~20份,瓜蒌皮20~30份,天麻30~60份,党参30~60份,白术10~30份,苍术10~20份,香附10~20份,炒栀子10~20份,山萸肉10~20份,莲子心5~15份,陈皮10~20份,茯苓20~60 份,荷叶20~30份,桑叶20~30份,红景天20~30份,银杏叶30~60份,枳实 10~15份,厚朴10~15份,龟板20~30份,砂仁6~10份,僵蚕10~20份,桔梗 10~15份。
该中药复方组合物的制备方法:(1)按以上所述的质量份数取青叶胆、瓜蒌皮、天麻、党参、白术、苍术、香附、炒栀子、山萸肉、莲子心、陈皮、茯苓、荷叶、桑叶、红景天、银杏叶、枳实、厚朴、龟板、砂仁、僵蚕、桔梗饮片,加水煎煮二次,每次1~2小时,合并煎液,滤过,浓缩滤液,加入体积浓度为85%乙醇进行醇沉处理,滤去沉淀物,滤液回收并80℃浓缩至相对密度 1.30~1.36,得浸膏;(2)取步骤得到的浸膏,与药学上可接受的载体制备成膏剂、口服液、颗粒剂、胶囊剂、片剂或滴丸剂型的药物。
以下通过临床试验、临床应用实例阐明本发明所述用于冠心病二级预防和辅助治疗的中药复方组合物的治疗效果。
方法:选取符合诊断为脾虚湿蕴、肝肾亏虚型冠心病不稳定型心绞痛患者 80例作为研究对象,随机分为中药组和对照组各40例。对照组用西药常规治疗,中药组在对照组的基础上加用本发明中药复方组合物治疗,采用中药浓煎剂剂型,两组疗程均为8周。疗程结束后对比统计分析两组患者在心绞痛发作次数、中医证候改善、硝酸酯类药物停减率及安全性指标方面的变化,评价其临床疗效与安全性。
结果:1、疗效指标:(1)中医证候积分及疗效:治疗后中药组患者中医证候积分与治疗前相比显著下降(P<0.01)优于对照组(P<0.01);对照组总有效率为55.00%,中药组总有效率为92.50%,中药组总有效率优于对照组(P<0.01)。见表1和表2。
(2)心绞痛症状积分及疗效:两组心绞痛积分较治疗前明显下降(P<0.01), 中药组心绞痛发作次数、程度及持续时间的积分下降更明显(P<0.05);对照组总有效率为85.00%,中药组总有效率为90.00%,中药组总有效率更高(P<0.05)。见表3和表4。
(3)硝酸酯类停减率疗效:对照组停减率为70.00%,中药组停减率为87.50%,中药组停减率更高(P<0.01)。见表5。
2、安全性指标:中药组治疗前后均未出现血、尿、便常规及肝肾功能异常,中药复方安全性良好。
结论:(1)该中药复方可以改善不稳定型心绞痛脾虚湿蕴、肝肾亏虚证患者的临床症状,临床应用安全可靠;(2)该中药复方可以降低硝酸酯类药物使用率、降低中医证候积分,在改善患者的心绞痛发作次数、程度及时间等方面疗效显著。
表1中医证候疗效比较
表2中医证候积分总分比较
表3心绞痛症状疗效比较
表4心绞痛症状积分比较
注:与治疗前比较,*P<0.05
表5硝酸酯类药物停减率比较
以下进一步列举3个典型临床案例说明本发明的效果:
1、邓某,男,47岁,反复发作胸闷胸痛3年余,加重1月。3年前经冠脉动脉造影确诊为冠心病,同时合并有高血压、2型糖尿病、高脂血症、高尿酸血症病史。进入6月梅雨季节以来,因心情压抑,感胸闷加重,胸骨区压迫感,伴气短、呼吸不畅,时有头晕,腰酸,困倦乏力,口干口苦粘腻不爽,大便溏薄,舌体胖大边有齿痕,苔薄黄舌根腻,脉细。服用本中药复方汤剂2周后,胸闷、头晕症状有所缓解,2月后诸症皆消,苔转为薄白。
2、陈某,女,52岁,活动后胸闷气短6年余,加重2周。自青年时期开始肥胖,6年前开始逐渐出现活动后胸闷,进一步检查发现合并高血压、高脂血症、 2型糖尿病,冠状动脉CTA提示左前降支冠状动脉狭窄50%。小满后2周来感胸闷加重,活动后尤甚,动则出汗较多,怕热,头晕,行走飘空感,困倦多寐,食后腹胀,大便时干时稀,矢气多,舌体胖大边有齿痕,苔白腻,脉弦。服用本中药复方汤剂2周后,胸闷、头晕症状改善明显,3月后诸症皆消,苔转为薄白,体重减轻5kg。
3、张某,男,68岁,冠心病支架植入术后6年,每年冬季反复发作胸闷胸痛,均需住院治疗。有高血压、高脂血症病史。11月底来诊。刻诊:形体肥胖,动则气短,多汗,时有头晕、头胀,面色红赤,行走不稳,口干口苦,腰膝酸软,食后嗳气频繁,大便黏腻不尽感,舌体胖大边有齿痕,苔黄白相间腻,脉细数。以本中药复方制成膏方,冬至开始服用,服用2月。3月后随访,冬季胸闷症状发作较往年明显减少,未再住院治疗。
为详细说明本发明,通过以下具体实施案例对本发明的使用方法做进一步描述。
实施例1:青叶胆10g,瓜蒌皮20g,天麻20g,党参30g,白术10g,苍术 10g,香附10g,炒栀子10g,山萸肉10g,莲子心5g,陈皮10g,茯苓20g,荷叶20g,桑叶20g,红景天20g,银杏叶30g,枳实10g,厚朴10g,龟板20g,砂仁6g,僵蚕10g,桔梗10g。将以上各种中药饮片置于砂锅中,加入清水至超过中药饮片约3cm,浸泡60min。大火煮沸后转小火煮20min,过滤分离滤液。药渣再次加入清水至超过中药饮片约3cm,大火煮沸后转小火煮15min,过滤分离滤液。合并两次滤液。每日一剂,分两次早晚饭后30min服用。
实施例2:青叶胆100g,瓜蒌皮200g,天麻200g,党参300g,白术100g,苍术100g,香附100g,炒栀子100g,山萸肉100g,莲子心60g,陈皮100g,茯苓200g,荷叶200g,桑叶200g,红景天20g0,银杏叶300g,枳实100g,厚朴100g,砂仁60g,僵蚕100g,桔梗100g,龟板400g。水煎取汁,浓缩,入龟板胶、添加冰糖或木糖醇、炼蜜等辅料后,收膏,分装,密闭,于阴凉、干燥处保存。每日2次,每次15~20ml,早晚空腹温开水化服。
总结
综上所述,证候学研究提示,湿邪、痰浊是冠心病的关键证素。但湿邪多产生于中焦脾胃,湿性重浊趋下,其逆传而上痹阻上焦胸阳尚需他邪引动。在现代快节奏的生活环境中,包括工作、生活压力等,长期情绪紧张、焦虑等负面情绪的影响下,气机不畅,最易伤肝。肝肾同源,肝郁易乘脾,脾虚生湿;肾虚肝旺而易生风。冠心病骤发时止、不发时如常人、病情变化迅速多端的发作特点与风邪致病有诸多似同性。既往学界对风邪与冠心病的关系虽有探索,但多局限于“外风”、“风药”、“风(风药)能胜湿理论”。申请人独辟蹊径,从肝肾亏虚相关的“内风”立论,联系冠心病的发生发展常合并高血压、中风等肝木亢盛生风之疾,故而提出痰湿阴邪痹阻胸阳的病机乃肝肾亏虚、内风引动痰湿伏邪而上乘阳位、痹阻胸中气机的“湿盛风引”全新病机理论:脏腑失和,阳亢化风,阴虚生风,肝热生风,瘀血生风,内风引动痰湿,瘀阻脉络,伤阳助痹。同时创新性提出“治痹必治湿,湿去胸阳驰;治痹必治风,风宁痹自通”的胸痹论治思路,以及“健脾疏肝益肾以绝湿生之源、燥湿利湿化湿以袪已生之湿”胸痹治湿之法和“补肝益肾健脾以袪生风之基、平肝清肝镇潜以消风火之象”胸痹治风之术,开拓冠心病的中医药病机认识与防治思路。在以上论治思路和治法引领下,研制出对应的中药复方组合物治疗冠心病脾虚湿蕴、肝肾亏虚证,经临床推广应用观察,在冠心病二级预防和辅助治疗中疗效显著。
Claims (3)
1.一种含青叶胆的中药复方组合物在制备预防和辅助治疗冠心病二级药物中的应用,其特征在于该中药组合物按照质量份数包括以下组分:青叶胆500~4000份,瓜蒌皮500~4000份,天麻2000~8000份,党参2000~8000份,白术500~4000份,苍术500~3000份,香附500~3000份,炒栀子500~3000份,山萸肉500~3000份,莲子心300~2000份,陈皮500~3000份,茯苓1000~8000份,荷叶1000~4000份,桑叶1000~4000份,红景天1000~4000份,银杏叶2000~8000份,枳实500~2000份,厚朴500~2000份,龟板1000~4000份,砂仁300~2000份,僵蚕500~3000份,桔梗500~2000份。
2.如权利要求1所述的一种含青叶胆的中药复方组合物在制备预防和辅助治疗冠心病二级药物中的应用,其特征在于该中药组合物的质量份数为:青叶胆1000~2000份,瓜蒌皮2000~3000份,天麻3000~6000份,党参3000~6000份,白术1000~3000份,苍术1000~2000份,香附1000~2000份,炒栀子1000~2000份,山萸肉1000~2000份,莲子心500~1500份,陈皮1000~2000份,茯苓2000~6000份,荷叶2000~3000份,桑叶2000~3000份,红景天2000~3000份,银杏叶3000~6000份,枳实1000~1500份,厚朴1000~1500份,龟板2000~3000份,砂仁600~1000份,僵蚕1000~2000份,桔梗1000~1500份。
3.如权利要求1或2所述中药复方组合物的制备方法,其特征在于包括如下方法步骤:(1)按所述的质量份数取青叶胆、瓜蒌皮、天麻、党参、白术、苍术、香附、炒栀子、山萸肉、莲子心、陈皮、茯苓、荷叶、桑叶、红景天、银杏叶、枳实、厚朴、龟板、砂仁、僵蚕、桔梗饮片,加水煎煮二次,每次1~2小时,合并煎液,滤过,浓缩滤液,加入体积浓度为85%乙醇进行醇沉处理,滤去沉淀物,滤液回收并80℃浓缩至相对密度1.30~1.36,得浸膏;(2)取步骤得到的浸膏,与药学上可接受的载体制备成膏剂、口服液、颗粒剂、胶囊剂、片剂或滴丸剂型的药物。
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