CN104306615A - 一种治疗冠心病的药品及其制备方法 - Google Patents
一种治疗冠心病的药品及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗冠心病的药品,由川芎、红花、地骨皮、槟榔、牡丹皮、枸杞六味中药组成,该中药组合物可以制备成药品,实验研究表明,本发明药品能够有效治疗冠心病。
Description
技术领域
本发明属于中药领域。具体涉及到一种制备治疗冠心病的组合物及其制备方法。
背景技术
冠心病,指由于脂质代谢不正常,血液中的脂质沉着在原本光滑的动脉内膜上,在动脉内膜一些类似粥样的脂类物质堆积而成白色斑块,称为动脉粥样硬化病变。这些斑块渐渐增多造成动脉腔狭窄,使血流受阻,导致心脏缺血,产生心绞痛。
冠心病是一种由冠状动脉硬化性(动脉粥样硬化)或动力性(血管痉挛)狭窄或阻塞引起心肌缺血缺氧或坏死的心脏病,亦称缺血性心脏病。
西医认为动脉粥样硬化(AS)发生机制有3种比较公认的学说:①脂质浸润学说:AS的形成是血管壁对血浆中浸入的脂质的一种反应性病变。②血栓形成学说AS的形成是由于局部附壁血栓嵌入内膜的结果。③损伤反应学说AS实质上是一种炎症过程。增厚的病灶是血管壁内结缔组织对致炎因素的~种增生性反应。实质上,上述3种学说是AS发生,发展的不同过程。冠心病的易患因素:①高血压,②高脂血症,⑦吸烟,④糖尿病,⑤肥胖,⑥家族史等。随着人们生活水平的提高、饮食结构的改变、人中老龄化以及紧张的工作压力,冠心病的发病率逐年增高
中医认为冠心病属于中医胸痹。本病多由素体阳虚寒邪内侵、或饮食劳逸、情志失调、年老体衰、瘀血痰饮或久嗜烟酒等原因引起。胸居阳位,宜清旷而忌邪侵。若胸阳不振;寒邪侵袭或阳虚水寒上攻;或寒痰血瘀上乘,均能导致“阴乘阳位”痹阻气机发为“胸痹”,该病是一种严重危害人类健康的常见病猝死率极高,占人口死亡数是1/3以上,是人类生命的一大杀手。
目前,治疗冠心病的药物种类很多,大多是采用西药治疗,治标不治本。其治疗途径多以采用扩冠和减慢心率的药物,提高心肌供氧 和降低心肌耗氧,从而减轻病情症状。但是,这些药物虽然能从一定程度上缓解病症,当始终存在着伤阴、耗气等缺陷。中药治疗虽然原料来源广,价格便宜,副作用小,但是现有的中药制剂存在疗效不确切、治愈率低等不足。
发明内容
本发明目的就是为了弥补已有技术的缺陷,深入研究冠心病的发病机理的基础上,提供一种制备治疗冠心病的药品及其制备方法。本发明在临床应用中安全性良好,未发现任何不良反应。
本发明的药品的原料药川芎、红花、地骨皮、槟榔、牡丹皮、枸杞六味中药组成。
本发明的药品的原料的重量比例为:川芎10-20g、红花8-15g、地骨皮20-40g、25-30g、槟榔6-15g、牡丹皮10-30g、枸杞10-20g。
本发明的药品的原料的重量优选为:川芎15g、红花10g、地骨皮25g、槟榔10g、牡丹皮20g、枸杞15g。
本发明的所述药品的原料的重量比例优选为:川芎15g、红花10g、地骨皮30g、槟榔8g、牡丹皮15g、枸杞15g。
本发明所述药品的原料的重量比例优选为:川芎20g、红花8g、地骨皮20g、槟榔10g、牡丹皮30g、枸杞15g。
本发明药品的活性成分制备方法,由以下步骤制成:
(1)药材净选:取组方中药材分别净选,称取药材;
(2)药材提取:加水煎煮两次,两次加水量分别为6-10倍量,煎煮时间为0.5-2小时,两次煎煮液合并得到水提物,加乙醇使含醇量为60%-85%,过滤,溶液除去溶剂得到提取物,干燥既得活性成分。
本发明药品的制剂剂型为胶囊剂、片剂、丸剂、颗粒剂、口服液、泡腾片或保健饮料。
本发明胶囊剂的制备方法由以下步骤制成:
(1)药材净选:取组方中药材分别净选,称取药材;
(2)药药材提取:加水煎煮两次,两次加水量分别为6-10倍量,煎煮时间为0.5-2小时,两次煎煮液合并得到水提物,加乙醇使含醇量为60%-85%,过滤,溶液除去溶剂得到提取物,干燥既得活性成分;
(3)制粒、装胶囊:取步骤(2)的浓缩液,加入浓缩液1-5倍重量的淀粉、糊精或乳糖中的一种或两种,采用稠膏制粒法,进行制粒,在50-70℃下干燥,整粒,装胶囊,既得胶囊剂。
本发明片剂的制备方法有以下步骤制成:
(1)药材净选:取组方中药材分别净选,称取药材;
(2)药材提取:加水煎煮两次,两次加水量分别为6-10倍量,煎煮时间为0.5-2小时,两次煎煮液合并得到水提物,加乙醇使含醇量为60%-85%,过滤,溶液除去溶剂得到提取物,干燥既得活性成分;
(3)制粒:取步骤(2)的浓缩液,加入浓缩液1-5倍重量的淀粉、糊精或乳糖中的一种或两种,采用稠膏制粒法,进行制粒,在50-70℃下干燥,整粒,得颗粒备用;
(4)压片:去步骤(3)所得颗粒,加入颗粒重量0.5-1%的硬脂 酸镁,混合均匀,压片,既得片剂。
优选的本发明胶囊剂制备方法,由以下步骤制成:
(1)药材净选:取组方中药材分别净选,称取药材;
(2)药材提取:加水煎煮两次,两次加水量分别为6-10倍量,煎煮时间为0.5-2小时,两次煎煮液合并得到水提物,加乙醇使含醇量为60%-85%,过滤,溶液除去溶剂得到提取物,干燥既得活性成分;
(3)制粒、装胶囊:取步骤(2)的浓缩液,加入浓缩液3倍重量的淀粉,采用稠膏制粒法,进行制粒,在65℃下干燥,整粒,装胶囊,既得胶囊剂。
优选的本发明片剂制备方法,由以下步骤制成:
(1)药材净选:取组方中药材分别净选,称取药材;
(2)药材提取:加水煎煮两次,两次加水量分别为6-10倍量,煎煮时间为0.5-2小时,两次煎煮液合并得到水提物,加乙醇使含醇量为60%-85%,过滤,溶液除去溶剂得到提取物,干燥既得活性成分;
(3)制粒、装胶囊:取步骤(2)的浓缩液,加入浓缩液3倍重量的淀粉,采用稠膏制粒法,进行制粒,在68℃下干燥,整粒,装胶囊,既得胶囊剂。
本发明中,川芎:味苦、性寒,有清热燥湿、泻火解毒、止血、安胎等功效。主治温热病、上呼吸道感染、肺热咳嗽、湿热黄胆、肺炎、痢疾、咳血、目赤、胎动不安、高血压、痈肿疖疮等症。
红花:辛,温。入心、肝经。活血通经,去瘀止痛。治经闭,癥瘕,难产,死胎,产后恶露不行、瘀血作痛,痈肿,跌扑损伤。
地骨皮:甘,寒,临床用于治疗高血压,糖尿病。
槟榔:苦,辛,温。归胃、大肠经。治杀虫消积,行气,利水,截疟。《药性论》:“宣利五脏六腑壅滞,破坚满气,下水肿,治心痛,风血积聚。”
牡丹皮:苦、辛,微寒。归心、肝、肾经。功能与主治:清热凉血,活血化瘀。
枸杞:甘,平。滋肾,润肺,补肝,明目。治肝肾阴亏,腰膝酸软,头晕,目眩,目昏多泪,虚劳咳嗽,消渴,遗精。
本发明的优点是:
本发明中药经科学合理配伍,使各药物的功效产生协同作用,调节心脏功能,对于治疗冠心病具有很好的疗效,安全可靠,副作用小。
实施例:
具体实施方式
下述实施例用于举例说明本发明药物的制备,但其不能对本发明的范围构成任何限制。
实施例1:
为了便于本发明药品的应用,将该药品制备成胶囊剂:
原料药配比:川芎15g、红花10g、地骨皮25g、槟榔10g、牡丹皮20g、枸杞15g。
制备方法:
(1)药材净选:取组方中药材分别净选,称取药材;
(2)药材提取:加水煎煮两次,两次加水量分别为6-10倍量,煎煮时间为0.5-2小时,两次煎煮液合并得到水提物,加乙醇使含醇量为60%-85%,过滤,溶液除去溶剂得到提取物,干燥既得活性成分;
(3)制粒、装胶囊:取步骤(2)的浓缩液,加入浓缩液3倍重量的淀粉,采用稠膏制粒法,进行制粒,在65℃下干燥,整粒,装胶囊,既得胶囊剂。
实施例2:
为了便于本发明药品的应用,将该药品制备成片剂:
原料药配比:川芎15g、红花10g、地骨皮25g、槟榔10g、牡丹皮20g、枸杞15g
制备方法:
((1)药材净选:取组方中药材分别净选,称取药材;
(2)药材提取:加水煎煮两次,两次加水量分别为6-10倍量,煎煮时间为0.5-2小时,两次煎煮液合并得到水提物,加乙醇使含醇量为60%-85%,过滤,溶液除去溶剂得到提取物,干燥既得活性成分;
(3)制粒:取步骤(2)的浓缩液,加入浓缩液4倍重量的淀粉,采用稠膏制粒法,进行制粒,在65℃下干燥,整粒,得颗粒备用;
(4)压片:去步骤(3)所得颗粒,加入颗粒重量0.5%的硬脂酸镁,混合均匀,压片,既得片剂。
实施例3:
为了便于本发明药品的应用,将该药品制备成胶囊剂:
原料药配比:川芎15g、红花10g、地骨皮30g、槟榔8g、牡丹皮15g、枸杞15g
制备方法:
(1)药材净选:取组方中药材分别净选,称取药材;
(2)药材提取:加水煎煮两次,两次加水量分别为6-10倍量,煎煮时间为0.5-2小时,两次煎煮液合并得到水提物,加乙醇使含醇量为60%-85%,过滤,溶液除去溶剂得到提取物,干燥既得活性成分;
(3)制粒、装胶囊:取步骤(2)的浓缩液,加入浓缩液2倍重量的乳糖和淀粉的混合辅料,采用稠膏制粒法,进行制粒,在60℃下干燥,整粒,装胶囊,既得胶囊剂,每粒胶囊的含药量大约为原药的2-3g。
实施例4:
为了便于本发明药品的应用,将该药品制备成口服液:
原料药配比:川芎15g、红花10g、地骨皮30g、槟榔8g、牡丹皮15g、枸杞15g。
制备方法:
(1)药材净选:取组方中药材分别净选,称取药材;
(2)药材提取:加水煎煮两次,两次加水量分别为6-10倍量,煎煮时间为0.5-2小时,两次煎煮液合并得到水提物,加乙醇使含醇量为60%-85%,过滤,溶液除去溶剂得到提取物,干燥既得活性成分;
(3)按照口服液常规的制备方法制备成口服液剂型
实施例6:
为了便于本发明药品的应用,将该药品制备成颗粒剂:
原料药配比:川芎20g、红花8g、地骨皮20g、槟榔10g、牡丹皮30g、枸杞15g。
制备方法:按常规制剂方法制成颗粒
7、典型病例:
病例1,张某,男,主诉心前区闷痛,气短,反复发作3年并逐渐 加重,患者心前区闷痛,每天发作2~3次,活动、劳累或受冷后加重。服用复方丹参滴丸可缓解。常伴有头晕、周身疲乏、双下肢沉重、血压18/12kPa,心律齐,率86次/min,舌质暗边尖有瘀点,口唇色暗,苔白,脉弦细。心电图检查:T波、I、avL、V4,V5低平,ST段V7、V8呈水平下移0.1mv。超声心动图检查有冠心病改变。血脂检查,胆固醇6.3mmol/L,甘油三脂2.1mmol/L,西医诊断:冠心病、劳累性心绞痛。中医诊断:胸痹、心痛。给予本发明实施例3制备的胶囊,每天两次,每次4粒,服药3d后,心前区闷痛明显减轻,每日发作1~2次可自行缓解,继服1周后,心前区闷痛未发作,疲乏、双下肢沉重感消失,连续服用4周,复查心电图T波I、avL、V4、V5低平较前改善,ST段、V7、V8水平型下移恢复正常。前方随证加减治疗3个月后,症状消失,复查心电图恢复正常,血脂检查胆固醇5.0mmol/L,甘油三脂1.4mmol/L。
病例2,王某,男,68岁。冠心病十多年,现心前区闷痛,常于干活动后发作,伴胸闷心慌,含服硝酸甘油可缓解,服用本发明实施例3制备的药物治疗一个疗程后,症状明显减轻,仅偶有轻微胸痛,继续服药治疗一个月后症状完全消失,随访1年未复发。
病例3,宋某,男,72岁,冠心病史多年,经常发作胸闷、胸痛,每天发作3-4次,含服硝酸甘油不能完全缓解。服用本发明实施例3制备的药物治疗一个疗程后,胸闷、胸痛症状减轻,又继续服用一个疗程,胸痛、胸闷一直未再发作,坚持再服药两个疗程后,胸痛、胸闷一直没有复发,头不晕、腿不麻,自诉症状完全消失,随访未见复发。
病例4,李某,男,56岁,体力活动时有心慌、气短、疲劳和呼吸困难感。长期左肩痛,经一般治疗反复不愈,出现脉搏不齐,过速或过缓。诊断为冠心病。服用本发明发明实施例3制备的药物1个月症 状减轻,左肩痛感消失,服用两个月,体力比以前明显增加,现继续服用。
8、临床试验:本实验治疗组所用的药物为用实施例3制备的胶囊剂。服用方法:每天服用两次,每次4粒,每次9-13克原药。
8.1一般资料:
收集2012年6月自2013年8月共观察冠心病140例,随机分为治疗组和对照组。治疗组75例中,男40例,女35例;年龄6O一95岁;病程15~36年。对照组65例中,男35例,女30例;年龄62~98岁;病程10—34年。两组患者性别、年龄、病程等一般资料比较,差异无统计学意义(P>0.05),具有可比性。
8.2中医诊断标准参照《中医内科疾病诊疗常规》中的有关标准拟定。胸部闷痛,甚至胸痛彻背;轻者仅感胸闷憋气,呼吸不畅;心电图检查有缺血性改变或运动试验阳性。中医心血瘀阻证候辨证标准参照《中药新药临床研究指导原则》中的有关标准拟定。胸部刺痛或绞痛,痛处固定不移,入夜更甚,时或心悸不宁,舌质紫暗,脉沉弦或结代。
8.3、治疗方法
对照组给予西医常规治疗,单硝酸异山梨酯片10mg,每天1次,口服;美托洛尔12.5mg,每天2次,口服;阿司匹林100mg,每天1次,口服。实验组在对照组治疗的基础上服用实施例3所得胶囊剂。使用方法为:每天服用两次,每次4粒,两组均以治疗15d为1个疗程,每个疗程间间隔15d,6个疗程结束后统计疗效。
8.4、疗效情况判定标准:显效:服用本品一个疗程,心电图显示冠状动脉供血明显改善,不适症状如心悸、胸闷、胸痛、心前区不适、乏力、头晕等症消失或基本消失,或由较重减到轻度,精力及体力明显增加;有效:服用本品一个疗程,心电图示慢性冠状动脉供血改善,不适症状减轻或部分消失,精力及体力增强;无效:服用本品一个疗程,不适症状无变化,甚至加重。
8.5结果:两组临床症状疗效比较:
试验组显效病例为56例,有效病例为17例,无效为2例,显效率与总有效率治疗组分别为74.6%、97%;对照组显效病例为28例,有效病例为20例,无效为2例,其中显效率与总有效率分别为43%、
73.8%,组间比较,差异有统计学意义(见表一)。两组不良反应发生率相似。(统计方法采用SPSS13.0统计软件进行数据处理,计量资料以均数±标准差()表示,采用t检验,计数资料采用x2检验。P<0.05为差异有统计学意义。)
表一、两组临床症状疗效比较
Claims (9)
1.一种治疗冠心病的药品,由其特征在于所述药品由川芎、红花、地骨皮、槟榔、牡丹皮、枸杞六味中药组成。
2.根据权利要求1所述的药品,其特征在于所述药品的原料的重量比例为:川芎10-20g、红花8-15g、地骨皮20-40g、25-30g、槟榔6-15g、牡丹皮10-30g、枸杞10-20g。
3.根据权利要求2所述的药品,其特征在于所述药品的原料的重量比例为:川芎15g、红花10g、地骨皮25g、槟榔10g、牡丹皮20g、枸杞15g。
4.根据权利要求2所述的药品,其特征在于所述药品的原料的重量比例为:川芎15g、红花10g、地骨皮30g、槟榔8g、牡丹皮15g、枸杞15g。
5.根据权利要求2所述的药品,其特征在于所述药品的原料的重量比例为:川芎20g、红花8g、地骨皮20g、槟榔10g、牡丹皮30g、枸杞15g。
6.根据权利要求2-5任一所述的药品的活性成分制备方法,其特征在于所述活性成分的制备方法由以下步骤制成:
(1)药材净选:取组方中药材分别净选,称取药材;
(2)药材提取:加水煎煮两次,两次加水量分别为6-10倍量,煎煮时间为0.5-2小时,两次煎煮液合并得到水提物,加乙醇使含醇量为60%-85%,过滤,溶液除去溶剂得到提取物,干燥既得活性成分。
7.根据权利要求2-5任一所述的药品,其特征在于所述药品的制剂剂型为胶囊剂、片剂、丸剂、颗粒剂、口服液。
8.根据权利要求7所述的药品,其特征在于所述胶囊剂的制备方法由以下步骤制成:
(1)药材净选:取组方中药材分别净选,称取药材;
(2)药材提取:加水煎煮两次,两次加水量分别为6-10倍量,煎煮时间为0.5-2小时,两次煎煮液合并,过滤,浓缩至60℃时测定相对密度为1.00-1.15的浓缩液,备用;
(3)制粒、装胶囊:取步骤(2)的浓缩液,加入浓缩液1-5倍重量的淀粉、糊精或乳糖中的一种或两种,采用稠膏制粒法,进行制粒,在50-70℃下干燥,整粒,装胶囊,既得胶囊剂。
9.根据权利要求8所述的药品,其特征在于所述胶囊剂的制备方法由以下步骤制成:
(1)药材净选:取组方中药材分别净选,称取药材;
(2)药材提取:加水煎煮两次,两次加水量分别为8倍量,煎煮时间为1小时,两次煎煮液合并,过滤,浓缩至60℃时测定相对密度为1.10的浓缩液,备用;
(3)制粒、装胶囊:取步骤(2)的浓缩液,加入浓缩液3倍重量的淀粉,采用稠膏制粒法,进行制粒,在68℃下干燥,整粒,装胶囊,既得胶囊剂。
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