CN105412517A - 一种含艾叶的治疗心肌梗死的中药组合物 - Google Patents
一种含艾叶的治疗心肌梗死的中药组合物 Download PDFInfo
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Abstract
本发明属于中药技术领域,公开了一种含艾叶的治疗心肌梗死的中药组合物。该中药组合物包括如下重量份的中药材:艾叶20-27份、丹参18-26份、罗布麻16-22份、茶树根17-23份、乳香15-19份、三七15-20份、当归12-18份、玄参8-14份、川牛膝6-13份、乌药7-13份、泽泻7-13份、荔枝核9-17份、薤白8-15份和甘草6-13份。该中药组合物在治疗心肌梗死方面药物作用全面,恰切病情,具有很好的治疗效果和显著的临床推广价值。
Description
技术领域
本发明属于中药技术领域,尤其涉及一种含艾叶的治疗心肌梗死的中药组合物。
背景技术
心肌梗死,又称心肌梗塞,是指心肌的缺血性坏死,多发生在冠状动脉病变的基础上,冠状动脉的血流急剧减少或中断,使相应的心肌出现严重而持久地急性缺血,最终导致心肌的缺血性坏死。临床上多有剧烈而持久的胸骨后疼痛,休息及硝酸酯类药物不能完全缓解,伴有血清心肌酶活性增高及进行性心电图变化,可并发心律失常、休克或心力衰竭,常可危及生命。中国患病率近年来呈明显上升趋势,每年新发至少50万,现患至少200万,男性多于女性,患病年龄在40岁以上者占87%—96.5%。
60%—80%的病人伴有或在发病前有高血压,近半数病人以往有心绞痛。吸烟、肥胖、糖尿病和缺少体力活动者,较易患病。本病与气候寒冷、气温变化有关。常在安静和睡眠时发病,部分病人则发病于剧烈体力劳动、精神紧张或饱餐之后,此外。休克、出血与心动过速、用力大便亦可诱发本病。
目前,治疗心肌梗死的药物包括β-受体阻滞剂、血管紧张素受体拮抗剂(ARB)、血管紧张素转换酶抑制剂、他汀类药物、醛固酮拮抗剂、内皮素受体拮抗剂、参麦注射液、葛根注射液、复方丹参滴丸、黄芪、丹参等。治疗心肌梗死的药物主要是以西药治疗为主,但西药只能缓解症状,对病理治疗缺乏手段,容易复发。
中医药治疗动脉粥样硬化已积累了一定的经验,在辨证施治原则的指导下,辨病与辨证相结合,既具有中医特色,又结合现代医学药理研究成果,与西药相比,中医药治疗本病,不仅疗效显著,而且无不良毒副作用,因而具有一定的优势。
中国发明专利申请201410608932.4公开了一种治疗心肌梗死的中药制剂,该中药制剂包括以下中药材:甘草、五味子、党参、降香、郁金、葛根、桃仁、熟地黄、山楂、桂枝和薤白。对治疗心肌梗死伴血压降低或休克者有一定疗效,但不能痊愈,复发率高。
近20年来,由于加强监护和治疗水平的提高,急性心肌梗死住院病死率明显降低,从30%左右降低至10%以下。但再梗死或多次梗死的患者增多,成为心肌梗死后死亡的主要原因之一。因此除在急性期应积极治疗外,还应加强心肌梗死后的康复和二级预防,以延长患者寿命,提高生活质量和恢复工作能力。
发明内容
针对目前心肌梗死临床治疗药物的不足,本发明的目的在于提供一种含艾叶的治疗心肌梗死的中药组合物,该中药组合物在治疗心肌梗死方面具有很好的治疗效果。
为实现本发明的目的,本发明技术方案如下:
本发明中药组合物包括如下重量份的中药材:
艾叶20-27份、丹参18-26份、罗布麻16-22份、茶树根17-23份、乳香15-19份、三七15-20份、当归12-18份、玄参8-14份、川牛膝6-13份、乌药7-13份、泽泻7-13份、荔枝核9-17份、薤白8-15份和甘草6-13份。
在该配比范围内,优选了3个疗效较为显著的配比:
配比1:艾叶27份、丹参26份、罗布麻22份、茶树根23份、乳香19份、三七20份、当归18份、玄参14份、川牛膝13份、乌药13份、泽泻13份、荔枝核17份、薤白15份和甘草13份。
配比2:艾叶20份、丹参18份、罗布麻16份、茶树根17份、乳香15份、三七15份、当归12份、玄参8份、川牛膝6份、乌药7份、泽泻7份、荔枝核9份、薤白8份和甘草6份。
配比3:艾叶24份、丹参24份、罗布麻20份、茶树根20份、乳香16份、三七17份、当归15份、玄参11份、川牛膝10份、乌药11份、泽泻9份、荔枝核13份、薤白12份和甘草9份。
相应地,本发明还提供所述中药组合物的制备方法,包括以下步骤:
1、按比例称取各味原料药材;
2、将乳香研磨成粉,备用;
3、将艾叶、丹参、罗布麻、茶树根、三七、当归、玄参、川牛膝、乌药、泽泻、荔枝核、薤白和甘草分别去杂质,洗净,烘干,粉碎成粗粉,与步骤2所得乳香粉混合,加入8-11倍药材重量的纯化水,煎煮2-3次,每次1-3小时,过滤,合并滤液,减压干燥,浓缩成55℃-65℃时相对密度为1.15-1.20的水提浓缩液,减压干燥,粉碎研磨,过100-200目筛,制成细粉,即为本发明中药组合物。
4、在中药原料药细粉中添加适当的辅料,以现代中药制剂常规工艺制成临床所需剂型,例如片剂、丸剂、散剂或胶囊剂等。
本发明中药组方所用中药材的来源、性味、归经及功效:
艾叶:本品为菊科植物艾的干燥叶。味辛、苦,性温;归肝、脾、肾经;散寒止痛,温经止血。
丹参:本品为唇形科植物丹参的干燥根及根茎。味苦,性微寒;归心、肝经;祛瘀止痛,活血通经,清心除烦。
罗布麻:本品为夹竹桃科植物罗布麻的全草。味甘苦,性凉;归肝经;清火,降压,强心,利尿。
茶树根:本品为山茶科植物茶的根。味苦,性凉;归心、肾经;强心利尿、活血调经、清热解毒。
乳香:本品为橄榄科乳香树属植物乳香树、药胶香树及野乳香树等,以其树干皮部伤口渗出的油胶树脂入药。味辛、苦,性温;归心、肝、脾经;活血止痛。
三七:本品为五加科植物三七的干燥根。味甘、微苦,性温;归肝、胃经;散瘀止血,消肿定痛。
当归:本品为伞形科植物当归的干燥根。味甘、辛,性温;归肝、心、脾经;补血活血,调经止痛,润肠通便。
玄参:本品为玄参科植物玄参的干燥根。味甘、苦、咸,性微寒;归肺、胃、肾经;凉血滋阴,泻火解毒。
川牛膝:本品为苋科植物川牛膝的干燥根。味甘、微苦,性平;逐瘀通经,通利关节,利尿通淋。
乌药:本品为樟科植物乌药的干燥块根。味辛,性温;归肺、脾、肾、膀胱经;顺气止痛,温肾散寒。
泽泻:本品为泽泻科植物泽泻的干燥块茎。味甘,性寒;归肾、膀胱经;利小便,清湿热。
荔枝核:本品为无患子科植物荔枝的干燥成熟种子。味甘、微苦,性温;归肝、肾经;行气散结,祛寒止痛。
薤白:本品为百合科植物小根蒜或薤的干燥鳞茎。味辛、苦,性温;归肺、胃、大肠经;通阳散结,行气导滞。
甘草:本品为豆科植物甘草、胀果甘草或光果甘草的干燥根。味甘,性平;归心、肺、脾、胃经;补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。
本发明中药组方的配伍分析:
本发明中药组方依据中医对心肌梗死的辨证认知,遵循中药的配伍理论,为了制成方便易用且疗效稳定的制剂,强化了药材的使用量。该组方是以艾叶、丹参、罗布麻为君药,强心利尿、活血通经;以茶树根、乳香、三七、当归为臣药,补血活血、止痛解毒;以玄参、乌药、泽泻、荔枝核、薤白为佐药,逐瘀顺气、泻火通淋;以川牛膝和甘草为使药,调和诸药药性,诸药配合,相辅相成,协同作用,共奏强心益气、利尿通淋、缓急止痛等功效,对心肌梗死有十分显著的疗效。
与现有技术相比,本发明有益效果总结如下:
1、本发明治疗心肌梗死的中药组合物,用药适宜,配伍严谨,主次分明,恰和病情,对心肌梗死的治疗针对性强。
2、本发明治疗心肌梗死的中药组合物,用药精简,用药量少,药材皆为中国药典所列,来源广、成本低。
3、本发明治疗心肌梗死的中药组合物,制备工艺简单易行,适合工业化生产。
4、临床试验结果证实,用药一个月,对90%以上急性心肌梗死临床志愿者有效。本发明治疗心肌梗死的中药组合物,显效快,治愈率高,疗程短。
具体实施方式
以下将通过具体实施例对本发明进行进一步描述,本领域技术人员应理解,本发明除以下实施例外还可做出其他类似的改变获得相似的结果而不脱离本发明的内容和精神范围。
实施例一
本发明实施例1中药组合物包括如下重量份的中药材:
艾叶24份、丹参24份、罗布麻20份、茶树根20份、乳香16份、三七17份、当归15份、玄参11份、川牛膝10份、乌药11份、泽泻9份、荔枝核13份、薤白12份和甘草9份;
制备方法如下:
1、按比例称取各味原料药材;
2、将乳香研磨成粉,备用;
3、将艾叶、丹参、罗布麻、茶树根、三七、当归、玄参、川牛膝、乌药、泽泻、荔枝核、薤白和甘草分别去杂质,洗净,烘干,粉碎成粗粉,与步骤2所得乳香粉混合,加入11倍药材重量的纯化水,煎煮3次,每次3小时,过滤,合并滤液,减压干燥,浓缩成65℃时相对密度为1.20的水提浓缩液,减压干燥,粉碎研磨,过200目筛,制成细粉,即为本发明中药组合物;
4、将步骤3所得细粉中添加适当的辅料,以现代中药制剂常规工艺制成散剂。
实施例二
本发明实施例2中药组合物包括如下重量份的中药材:
艾叶20份、丹参18份、罗布麻16份、茶树根17份、乳香15份、三七15份、当归12份、玄参8份、川牛膝6份、乌药7份、泽泻7份、荔枝核9份、薤白8份和甘草6份;
制备方法如下:
1、按比例称取各味原料药材;
2、将乳香研磨成粉,备用;
3、将艾叶、丹参、罗布麻、茶树根、三七、当归、玄参、川牛膝、乌药、泽泻、荔枝核、薤白和甘草分别去杂质,洗净,烘干,粉碎成粗粉,与步骤2所得乳香粉混合,加入8倍药材重量的纯化水,煎煮2次,每次1小时,过滤,合并滤液,减压干燥,粉碎研磨成粗粉,备用;
4、将步骤3所得细粉中添加适当的辅料,以现代中药制剂常规工艺制成胶囊剂。
实施例三
本发明实施例3中药组合物包括如下重量份的中药材:
艾叶27份、丹参26份、罗布麻22份、茶树根23份、乳香19份、三七20份、当归18份、玄参14份、川牛膝13份、乌药13份、泽泻13份、荔枝核17份、薤白15份和甘草13份;
制备方法如实施例一。
实施例四
本发明实施例4中药组合物包括如下重量份的中药材:
艾叶24份、丹参24份、罗布麻20份、茶树根20份、乳香16份、三七17份、当归15份、玄参11份、川牛膝10份、乌药11份、泽泻9份、荔枝核13份、薤白12份和甘草9份;
制备方法如实施例二。
本发明中药组合物药效学研究:
试验例一:本发明中药组合物对心肌梗死模型小鼠的影响研究
1、实验目的及方法
目的:根据《中药新药药理学研究指南》的要求,研究本发明中药组合物在治疗心肌梗死的主要药效学。取用本发明实施例一所得中药散剂,通过组织病理检查,观察其高、中、低剂量对心肌梗死小鼠模型的影响。
方法:选取60只C57/B6小鼠(购自北京维通利华实验动物技术有限公司;体重为20-30g),其中50只于麻醉状态下在左侧第3、4肋间隙挤出心脏,结扎冠状动脉左前降支建立小鼠心肌梗死模型。另外10只小鼠不结扎冠状动脉,其余操作与前50只小鼠相同,设为假手术组。
将建立好的心肌梗死小鼠模型随机分为5组,分别为本发明中药组合物的高、中、低剂量组、阳性对照组和模型组。高、中、低剂量组分别给予35mg/Kg、25mg/Kg、15mg/Kg中药组合物散剂处理,灌胃用药,每天2次,连续用药30天;阳性对照组和模型组分别给予25mg/Kg辛伐他汀片(安徽永生堂药业有限责任公司生产;国药准字H20083382)和等容积生理盐水处理,条件同高、中、低剂量组。用药30天后,1%戊巴比妥钠(80mg/Kg)麻醉所有小鼠,开胸肉眼观察心脏形态,肝素钠生理盐水灌洗心脏,摘取心脏。在左冠状动脉结扎点以下取垂直于左室长轴横断片段切片,切片厚度4μm,行HE染色,梗死面积(%)=[(左心室梗死部位心内膜长/总心内膜周长)/2+(左心室梗死部位心外膜长/总心外膜周长)/2]×100%,应用专业图像分析软件IPP6.0进行计算。标本采集在试验期间,每周称量体重一次。
统计学处理试验数据均采用均数±标准差来表示,组间差异显著性用t检验比较,P<0.05为有显著性差异。采用SPSS19.0统计软件进行数据处理。
2、实验结果:如表1所示。
表1心肌梗死小鼠模型心肌梗死面积比
注:与模型组比较,**P<0.01,***P<0.001;与阳性对照组比较,#P<0.05,##P<0.01。
3、结论
本实验通过研究本发明实施例一中所得中药组合物散剂高、中、低剂量对小鼠心肌梗死面积的影响来判定本发明中药组合物在心肌梗死方面的疗效。本实验选取50只小鼠通过手术结扎冠状动脉建立心肌梗死模型,另外10只小鼠则作为假手术组。模型组小鼠心肌梗死面积较大,说明心肌梗死模型小鼠建立成功。本发明中药组合物高、中、低剂量组的心肌梗死面积与模型组相比,大大减少,说明其具有良好的治疗心肌梗死的效果。此外,本实验用60只小鼠作试验动物,连续30天给药,小鼠无一死亡,处死小鼠解剖观察各脏器未发现毒性反应,小鼠体重亦无明显变化,给药组与假手术组小鼠无明显差异。可见,本发明中药组合物的三个剂量组均可大大降低大鼠心肌梗死面积,且其安全性高,临床推广价值高。
试验二:本发明中药组合物对心肌梗死临床志愿者患者的临床疗效观察
一、病例及诊断标准
1、西医诊断标准:
急性心肌梗塞诊断至少具备下列3条标准中的2条:
①血性胸痛的临床病史
②心电图的动态演变
起病时(急性期)面向梗塞区的导联出现异常Q波和ST段明显抬高,后者弓背向上与T波连接呈单向曲线,R波减低或消失;背向梗塞区的导联显示R波增高和ST段压低。在发病后数日至2周左右(亚急性期),面向梗塞区的导联ST段逐渐恢复到基线水平,T波变为平坦或显着倒置;背向梗塞区的导联T波增高。发病后数周至数月(慢性期)T波可呈V形倒置,其两肢对称波谷尖锐异常,Q波以后常永久存在,而T波有可能在数月至数年内恢复。
②肌坏死的血清心肌标记物浓度的动态改变
血清肌酸磷酸激酶(CK或CPK)发病6小时内出现,24小时达高峰,48~72小时后消失,阳性率达92.7%。
根据相邻导联ST段是否抬高,分为ST段抬高型心肌梗死和非ST段抬高型心肌梗死。
2、中医诊断标准:
①心血癖阻:心胸阵痛,如刺如绞,固定不移,入夜为甚,伴有胸闷心悸,面色晦暗,舌质紫暗,或有癖斑,舌下脉络青紫,脉沉涩或结代。
②寒凝心脉:心胸痛如缩窄,遇寒而作,形寒肢冷,多形体肥胖,胸闷心悸,甚则喘息不得卧,舌质淡,苔白滑,脉沉细或弦紧。
③痰浊内阻:心胸窒闷或如物压,气短喘促,多形体肥胖,肢体沉重,肮痞痰多口粘,舌苔浊腻,脉滑。痰浊化热则心痛如灼,心烦口干,痰多黄稠,大便秘结,舌红苔黄腻,脉滑数。
④心气虚弱:心胸隐痛,反复发作,胸闷气短,动则喘息,心悸易汗,倦怠懒言,面色苍白,舌暗淡或有齿痕,苔薄白,脉弱或结代。
⑤心肾阴虚:心胸隐痛,久发不愈,心悸盗汗,心烦少寐,腰膝酸软,耳鸣头晕,气短乏力,舌红,苔少,脉细数。
⑥心肾阳虚:胸闷气短,遇寒则痛,心痛彻背,形寒肢冷,动则气喘,一心悸汗出,不能平卧,腰酸乏力,面浮足肿,舌淡胖,苔白,脉沉细或脉微欲绝。
⑦气阴两虚:心胸疼痛时作,或灼痛,或闷痛,心悸怔忡,胸闷气短,动则喘息,倦怠懒言,口干盗汗,舌红少津,苔薄或剥,脉弱而数或结代。
以上7种症候均可单独出现,①和④同时出现可诊断为气虚血癖证,①、③和④同时出现可诊断为气虚痰癖证。
二、临床试验。
1、一般资料
所有入选的急性心肌梗死患者均为临床志愿者,共200名,年龄为18岁-80岁,平均年龄50.3岁,男女比例为1:1。随机分为治疗组100名和对照组100名。两组年龄、症状等影响因素,经统计学处理,无显著性差异,符合分组条件。
2、治疗方法
治疗组:取用本发明实施例二制备所得中药组合物胶囊剂,一次1粒,每粒胶囊含生药0.5g,一日服用2次,连用30天。
对照组:使用阳性对照药福辛普利钠片(中美上海施贵宝制药有限公司生产;国药准字H19980797),一次1片,一日服用2次,连用30天。
3、临床疗效评价标准
参考《中医心病诊断疗效标准与用药规范》制定:
显效:胸闷、心悸等临床症状均明显改善或者消失;
有效:临床症状有一定程度的改善;
无效:症状无明显改善或有严重的趋势。
4、治疗结果,如表2所示。
表2治疗效果
5、结论
本次临床试验的临床志愿者患者均为急性心肌梗死患者,未包含合并精神病、恶性肿瘤、严重肝、肾、造血系统、神经系统等原发性疾病者。从临床总有效率上可看出,本发明中药组合物的总有效率为93%,高于对照组的总有效率。所有受试者无一加重病情,并经体格检查,血、尿常规、心电图、肝肾功能等安全性检查,进一步证实本发明用于治疗心肌梗死安全有效,具有推广应用的价值。
Claims (6)
1.一种含艾叶的治疗心肌梗死的中药组合物,其特征在于,所述中药组合物包括如下重量份的中药材:
艾叶20-27份、丹参18-26份、罗布麻16-22份、茶树根17-23份、乳香15-19份、三七15-20份、当归12-18份、玄参8-14份、川牛膝6-13份、乌药7-13份、泽泻7-13份、荔枝核9-17份、薤白8-15份和甘草6-13份。
2.根据权利要求1所述的含艾叶的治疗心肌梗死的中药组合物,其特征在于,所述中药组合物包括如下重量份的中药材:
艾叶24份、丹参24份、罗布麻20份、茶树根20份、乳香16份、三七17份、当归15份、玄参11份、川牛膝10份、乌药11份、泽泻9份、荔枝核13份、薤白12份和甘草9份。
3.根据权利要求1所述的含艾叶的治疗心肌梗死的中药组合物,其特征在于,所述中药组合物包括如下重量份的中药材:
艾叶20份、丹参18份、罗布麻16份、茶树根17份、乳香15份、三七15份、当归12份、玄参8份、川牛膝6份、乌药7份、泽泻7份、荔枝核9份、薤白8份和甘草6份。
4.根据权利要求1所述的含艾叶的治疗心肌梗死的中药组合物,其特征在于,所述中药组合物包括如下重量份的中药材:
艾叶27份、丹参26份、罗布麻22份、茶树根23份、乳香19份、三七20份、当归18份、玄参14份、川牛膝13份、乌药13份、泽泻13份、荔枝核17份、薤白15份和甘草13份。
5.根据权利要求1-4任一所述的含艾叶的治疗心肌梗死的中药组合物,其特征在于,所述中药组合物被制成片剂、丸剂、散剂和胶囊剂。
6.根据权利要求1-5任一所述的含艾叶的治疗心肌梗死的中药组合物的制备方法,其特征在于,所述中药组合物的制备方法包括以下步骤:
步骤1、按比例称取各味原料药材;
步骤2、将乳香研磨成粉,备用;
步骤3、将艾叶、丹参、罗布麻、茶树根、三七、当归、玄参、川牛膝、乌药、泽泻、荔枝核、薤白和甘草分别去杂质,洗净,烘干,粉碎成粗粉,与步骤2所得乳香粉混合,加入8-11倍药材重量的纯化水,煎煮2-3次,每次1-3小时,过滤,合并滤液,减压干燥,浓缩成55℃-65℃时相对密度为1.15-1.20的水提浓缩液,减压干燥,粉碎研磨,过100-200目筛,制成细粉,即为本发明中药组合物。
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