CN104288709A - 用于心绞痛的中成药物制剂 - Google Patents
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Abstract
本发明属于药物制剂领域,涉及一种心绞痛的中成药物制剂,其由下述原料制备而得,黄芪、薤白、积雪草、栀子、天竺黄、赤芍、三七、川芎、地锦草、五灵脂、黄花菜、丹参、神曲、女贞子、玉竹、蒲黄、槐米、虎杖、连翘、合欢花、厚朴、莪术、银杏叶、肉豆蔻、马钱子。本发明的中成药物制剂对心绞痛疗效确切,无副作用、价格低廉,制作简便,具有广阔的应用前景。
Description
技术领域
本发明属于中药药物技术领域,具体涉及一种用于心绞痛的中成药物制剂。
背景技术
心绞痛是由于冠状动脉粥样硬化和(或)冠状动脉功能性改变(痉挛)导致冠状动脉供血不足,心肌暂时缺血、缺氧所引起的以发作性胸痛或胸部不适为主要表现的一组临床综合征。属中医“胸痹心痛”范畴。中医学认为毒素体心肾气阳不足,导致胸阳不振。七情内伤导致气滞。饮食不节,劳伤过度,损伤脾胃,酿生痰浊。寒邪外袭,导致寒疑心脉。上述诸种病邪因素痹阴心脉而为胸痹心痛。其病机主要以心肾虚弱为本,以阳气虚为主,久病阳损及阴,阴阳俱虚。以气滞血瘀,寒疑,痰浊为标。其诊断的症状:(1)左侧胸膺或膻中处突发憋闷而痛,疼痛性质为灼痛、绞痛、刺痛或隐痛、含糊不清的不适感等,疼痛常可窜及肩背、前臂、咽喉、胃脘部等,甚者可卅手少阴、手厥阴经循行部位窜至中指或小指,常兼心悸。(2)突然发病,时作时止,反复发作。持续时间短暂,一般几秒至数十分钟,经休息或服药后可迅速缓解。(3)多见于中年以上,常因情志波动,气候变化,多饮暴食,劳累过度等而诱发。亦有无明显诱因或安静时发病者。(4)心电图应列为必备的常规检查,必要时可作动态心电图、标测心电图和心功能测定、运动试验心电图。休息时心电图明显心肌缺血,心电图运动试验阳性,有助于诊断。
祖国医学对心绞痛的认识由来已久,对此病的记载首见于《内经》,如《素问·标本病传论》“心病先心痛”。《金匮要略》记载其典型症状为“胸痹之病,喘息咳唾,胸背痛,短气”。大多数医家认为本病病机为本虚标实。本虚主要包括气、血、阴、阳之虚,标实则为瘀血、寒凝、痰浊、气滞诸证。其病位在心,但与脾、肝、肾关系密切。张治祥等认为肾虚是冠心病发病的病机核心。探析其理,冠心病多见于40岁以上的中老年人,说明该病的发生与衰老有关。而人体的衰老过程也就是肾精不断亏虚的过程,如《素问·上古天真论篇》曰:“五八,肾气衰,发堕齿槁……七八,肝气衰,筋不能动,天癸竭,精少,肾藏衰,形体皆极。八八,则齿发去。”倪量等认为随着社会的发展,人们生活习惯改变,多进膏粱厚味,嗜食油腻醇酒,损伤脾胃,变生痰浊,影响气机,使胸阳不展而发为胸痹,因此诊治冠心病应从沿袭多年的注重瘀血病机转为“治痰为先”的思路上来。如今,随着人们生活节奏的日益加快,各种压力及不良情绪导致其发病率呈现出逐年上升的趋势,已成为严重威胁中老年人生活健康的常见病、多发病,且发病人群逐渐年轻化。因此,对心绞痛的防治已成为当前中西医重要的研究课题之一。
目前,临床上不断有新的治疗心绞痛的药物,包括西药和中成药和新的介入性治疗方法出现,但这些均未能达到真正令人满意的效果。开发一种高效、低毒、质量稳定的用于心绞痛的中成药物制剂是本发明的目的。
发明内容
本发明的目的是采用中医理论,提供一种活血化瘀、行气止痛,标本兼治、副作用小、安全方便、价格低廉的中成药物。
本申请发明人根据大量已有文献及自己多年的医疗实践,通过对传统中药的研究,从整体看,本病的发生与年老体虚、肾气不足、膏粱厚味、脾胃损伤、七情内伤、气滞血瘀、思考劳倦、伤及心脾等因素有关,也是气血瘀滞、心脉孪急之因。因此在胸痹的治疗当中,既要注意益气活血通络治标,亦要重视补肾培元治本。传统中医学“水火既济、心肾相关”、“治心之所以治肾,而治肾之所以治心。”的这种“心肾相关”的治疗学理论为补肾法治疗心衰、心绞痛提供了理论依据。同时根据“通则不痛”、“久病入络”的理论观点,在心衰合并心绞痛的治疗上要加以活血通络之品,这也是与符合现代医学微观理论相符合的。
在此基础上,本发明人结合辩证论证,多方收集众家之长,寻求最佳治疗方案,从祖国医学宝库中,筛选出活血化瘀、行气止痛的治疗心绞痛的天然中药,按中医理论组方,结合传统中医技术精心配制成本发明的治疗心绞痛的中药组合物,对心绞痛有治标治本的功效。
为实现上述目的,本发明采用的技术方案如下:
一种用于心绞痛的中成药物制剂,其特征在于其由下述原料制备而得:
黄芪、薤白、积雪草、栀子、天竺黄、赤芍、三七、川芎、地锦草、五灵脂、
黄花菜、丹参、神曲、女贞子、玉竹、蒲黄、槐米、虎杖、连翘、合欢花、
厚朴、莪术、银杏叶、肉豆蔻、马钱子。
优选地,按照下述原料配比制备:
黄芪40份、薤白35份、积雪草35份、栀子30份、天竺黄30份、
赤芍28份、三七28份、川芎25份、地锦草25份、五灵脂25份、
黄花菜22份、丹参22份、神曲20份、女贞子20份、玉竹20份、
蒲黄18份、槐米18份、虎杖15份、连翘15份、合欢花15份、
厚朴10份、莪术10份、银杏叶7份、肉豆蔻7份、马钱子5份。
本发明的中成药物制剂其制备方法的具体操作步骤优选为:
1)按照重量份数称取各原料药,备用;
2) 取积雪草、栀子、天竺黄、赤芍、三七、川芎、女贞子、玉竹、莪术、银杏叶、肉豆蔻、马钱子混合后,在冷水中浸泡30分钟,水与上述原料药重量比例为2:1;大火烧开后,文火烧20分钟,滤去沉渣,浓缩成密度为1.2g/ml的浸膏,80℃烘干后,粉碎成粉末;
3)取剩余成分加70%乙醇浸泡1.5小时,提取两次,每次1-2小时,合并提取液,滤过,浓缩成密度为1.2g/ml的浸膏,干燥后粉碎;
4)步骤2)、步骤3)制备的粉末搅拌均匀,灭菌消毒制得胶囊剂产品。
使用方法:口服一次0.1g,一日三次。
本发明的实验证明,本发明提供了一种能有效治疗心绞痛疾病的中成药物为及其制备方法,并严格控制了处方中主要药效物质的含量和比例,进行动物实验,发现本药物具有明显改善心梗后心肌重塑引起的心功能参数、血流动力学及心室组织结构的改变,可有效阻止缺血性心肌重塑引起的心功能恶化;明显缓解冠心病心绞痛和抗心肌缺血的作用,其产品的研发为医务工作者和患者提供一个更好的选择,使冠心病心绞痛的治疗药物更加完善与合理。
本发明具有下述优点:
本发明药物的组分均采用天然的中药原料,其配制简便,药源广泛,成本低廉,其遵循中医的处方用药原则,诸药合用,相得益彰;
本发明制剂服用量小,药物有效成分易于释放,吸收快,生物利用度高,使药效能够充分发挥,经临床应用验证,其疗效显著可靠,药性平和,未出现毒副作用,应用前景广阔;
具体实施方式
实施例1
一种用于心绞痛的中成药物制剂,其特征在于其由下述重量配比原料制备而得
黄芪40份、薤白35份、积雪草35份、栀子30份、天竺黄30份、
赤芍28份、三七28份、川芎25份、地锦草25份、五灵脂25份、
黄花菜22份、丹参22份、神曲20份、女贞子20份、玉竹20份、
蒲黄18份、槐米18份、虎杖15份、连翘15份、合欢花15份、
厚朴10份、莪术10份、银杏叶7份、肉豆蔻7份、马钱子5份。
本发明的中成药物制剂其制备方法的具体操作步骤为:
1)按照重量份数称取各原料药,备用;
2) 取积雪草、栀子、天竺黄、赤芍、三七、川芎、女贞子、玉竹、莪术、银杏叶、肉豆蔻、马钱子混合后,在冷水中浸泡30分钟,水与上述原料药重量比例为2:1;大火烧开后,文火烧20分钟,滤去沉渣,浓缩成密度为1.2g/ml的浸膏,80℃烘干后,粉碎成粉末;
3)取剩余成分加70%乙醇浸泡1.5小时,提取两次,每次1小时,合并提取液,滤过,浓缩成密度为1.2g/ml的浸膏,干燥后粉碎;
4)步骤2)、步骤3)制备的粉末搅拌均匀,灭菌消毒制得胶囊剂产品。
使用方法:口服一次0.1g,一日三次。
实施例2
临床实验
抗缺氧实验
一、动物:
受试动物:健康小鼠20-25g
二、药品与试剂:
受试药物,实施例1制备的药物;阳性对照药:心得安,由天津力生制药股份有限公司提供;盐酸异丙肾上腺素,由上海禾丰制药有限公司提供。
三、实验方法:
小鼠60只,随机分为3组,每组20只,模型组灌胃给予生理盐水,实验组给与实施例1制备的药物组合物20mg/kg,阳性对照组给与心得安20mg/kg。灌胃1h后,正常组皮下注射等容量生理盐水,其余各组皮下注射盐酸异丙肾上腺素20mg/kg,15min后放入装有15g钠石灰的250mL广口瓶中,立即密闭瓶口,记录缺氧状态下小鼠存活时间。并按照下述公式计算保护率:
所得到的实验结果列为:
模型组存活时间为22.23±6.37
实验组存活时间为51.07±7.24
对照组存活时间为46.45±7.46
与模型组比较:P<0.01
结果表明,本发明的治疗冠心病心绞痛的中药药物能够显著延长异丙肾上腺素所致的心肌缺氧小鼠的存活时间。
实施例3
临床资料
选择确诊为心绞痛患者76例,随机分为两组。治疗组38例,男21例,女17例,年龄52~78岁,病程6个月~4年。对照组38例,男22例,女16例,年龄49~76岁,病程5个月~4年,两组病例治疗前在性别、年龄、病程等方面无显著差异(P>0.05),具有可比性。
诊断标准
西医诊断标准
参照中华医学会心血管病分会《不稳定性心绞痛诊断和治疗建议》。
中医诊断与辨证标准
1990年修订的冠心病中医辨证标准进行中医辨证分型。总体上分为血瘀证和非血瘀证。血瘀证候评分参照中国中西医结合学会活血化瘀专业委员会制定的血瘀证的诊断标准。结合冠心病患者的发病特点进行观察,包括心绞痛、舌质紫暗或有瘀斑、口唇及齿龈紫暗、舌下脉络曲张、脉涩或结代等症状和体征并进行评分:(1)心绞痛:轻度(有典型心绞痛发作,发作持续时间数分钟,每周至少发作2-3次,但疼痛不重,有时需含服硝酸甘油)记3分;中度(每天有较典型的心绞痛发作.每次持续数分钟,每次需含服硝酸甘油)记6分;重度(每人有数次较典型的心绞痛发作,持续数分钟,需数次含服硝酸甘油)记10分。(2)舌质紫暗或有瘀斑:轻度(舌质暗红)记3分;中度(舌质暗红,有散在疲斑)记6分;重度(舌质紫暗)记9分。(3)口唇及齿龈暗:轻度(口唇或齿龈颜色暗红)记3分;中度(口唇或齿龈颜色紫暗)记5分;重度(口唇或齿龈颜色紫暗且有瘀斑)记6分。(4)舌下脉络曲张:轻度(舌根部脉络曲张)记8分;中度(舌下脉络曲张超过舌下脉的1/2)记9分;重度(整个舌下脉曲张)记10分。(5)脉涩或结代:脉结代,记8分;脉涩,记10分。上述病例,无论标实还是本虚,皆同时存在多种兼证。
排除标准
①有下列情况之一者不能入选,血压剧烈波动控制不佳者,重度神经官能症、更年期症候群、颈椎病所致胸痛者,重度心肺功能不全,重度心律失常,肝、肾、造血系统等严重原发性疾病,精神病,主动脉夹层及出血性疾病等;②孕妇或哺乳期的妇女;③其他干扰试验的完成或影响对结果解释的主要疾病或因素。
治疗方法:
治疗组(本发明组)服用实施例1制备的药物;
对照组复方丹参滴丸组,天津天士力制药股份有限公司生产,用法每天3次,每次10丸,一日三次,一个月为一疗程。
治疗结果:
疗效标准心绞痛和心电图疗效参考《冠心病心绞痛及心电图疗效评定标准》(中西医结合治疗冠心病心绞痛及心律失常座谈会,1979,上海)
具体治疗结果如下表1(P<0.05)
表1
组别 | 例次 | 显效 | 有效 | 无效 | 总有效率(%) |
治疗组 | 38 | 22 | 14 | 2 | 94.7 |
对照组 | 38 | 13 | 15 | 10 | 73.7 |
由上表可见:治疗组缓解心绞痛显效率和总有效率均明显优于对照组,有显著性差异。
本发明采用的上述各中西药互作配伍,能发挥其协同治病作用,所用中药原料各成分之间具有药效相互交织相互促进和协调效能,经临床验证,对冠心病心绞痛有很好的治疗效果,本申请人多年的医疗实践中,治愈的病例数目众多,均取得良好的效果,而且成本低廉,减轻患者的负担。
本申请的治疗冠心病心绞痛的药物组合物成本低廉,疗效显著,具有广阔的应用前景。
Claims (4)
1. 一种用于心绞痛的中成药物制剂,其特征在于,所述药物制剂由下述原料药制备而得:
黄芪、薤白、积雪草、栀子、天竺黄、赤芍、三七、川芎、地锦草、五灵脂、
黄花菜、丹参、神曲、女贞子、玉竹、蒲黄、槐米、虎杖、连翘、合欢花、
厚朴、莪术、银杏叶、肉豆蔻、马钱子。
2.根据权利要求1所述的药物制剂,其特征在于,所述药物制剂由下述重量份的原料药制备而得:
黄芪40份、薤白35份、积雪草35份、栀子30份、天竺黄30份、
赤芍28份、三七28份、川芎25份、地锦草25份、五灵脂25份、
黄花菜22份、丹参22份、神曲20份、女贞子20份、玉竹20份、
蒲黄18份、槐米18份、虎杖15份、连翘15份、合欢花15份、
厚朴10份、莪术10份、银杏叶7份、肉豆蔻7份、马钱子5份。
3.根据权利要求1-2所述的药物制剂,其特征在于,所述药物制剂的制备方法如下:
1) 按照重量份称取各原料药,备用;
2) 取积雪草、栀子、天竺黄、赤芍、三七、川芎、女贞子、玉竹、莪术、银杏叶、肉豆蔻、马钱子,混合,然后在水中浸泡30分钟,水与上述原料药重量比例为2:1;大火烧开后,文火烧20分钟,滤去沉渣,浓缩成密度为1.2g/ml的浸膏,80℃烘干后,粉碎成粉末;
3)取剩余原料药,加70%乙醇浸泡1.5小时,提取两次,每次1-2小时,合并提取液,滤过,浓缩成密度为1.2g/ml的浸膏,干燥后粉碎;
4)步骤2)和步骤3)制备的粉末搅拌均匀,灭菌消毒即得。
4.权利要求1-3所述的药物制剂的应用。
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