CN105853937A - 一种治疗心绞痛的药物组合物及其制备方法 - Google Patents
一种治疗心绞痛的药物组合物及其制备方法 Download PDFInfo
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Abstract
本发明属于中药技术领域,公开了一种治疗心绞痛的药物组合物及其制备方法,该药物组合物由以下中药材制成:熟地黄,黄精,柴胡,白芍,郁金,山楂,牛黄,半夏,细辛,草乌头,山杜仲,茯苓,诸药合用具有补气养血,化瘀祛痰,宣痹通络的显著功效。药理实验和临床试验表明,本发明药物组合物能够起到扩张冠状动脉、降低心肌耗氧量、抑制血小板聚集、抗炎、调脂的作用,配合西药治疗冠心病引起的心绞痛,能显著提高治愈率,改善患者肉体痛苦和经济负担,值得临床推广应用。
Description
技术领域
本发明属于中药技术领域,具体涉及一种治疗心绞痛的药物组合物及其制备方法。
背景技术
心绞痛是冠心病的一种临床表现,具体症状为胸骨后的压榨感,闷胀感,可伴随焦虑,常持续3到5分钟,可发散到左侧臂部,肩部,下颌,咽喉部,背部,也可放射到右臂。有时候心绞痛不典型,可表现为气急,晕厥,腹痛,嗳气,尤其在老年人。冠心病心绞痛是心血管系统的常见病,多发病,严重危害了人民的身体健康。随着人们生活水平的提高,饮食习惯的改变,工作压力的增加等诸多因素的影响,该病发病率逐年上升,并有发病人群呈年轻化的趋势,已经引起人们的高度重视。
临床上治疗心绞痛的方法很多,我们常用硝酸脂类、口受体阻滞剂、钙离子拮抗剂等治疗,但由于西药治疗可暂时缓解临床症状,长期应用会产生耐药性.而且副作用多,不宜长期使用。
中医认为本病的病位在心,与心、肝、脾、肾诸脏的盛衰有关,肾气已虚,鼓动血脉运行之力不足,机体内已有血行迟缓,聚湿生痰,瘀而不通之势,这是本病发生的前提和基础。其病因病机为本虚标实证,阳虚、气虚、阴虚、血虚为本,而痰浊、气滞、血瘀为本病之标。在临床中心绞痛发作期的从健脾化痰,活血化瘀,舒肝理气入手,能较好地缓解冠心病心绞痛的临床症状,改善部分客观指标,并且不良反应亦少,配合西药互补治疗冠心病心绞痛能够取得较好疗效。
发明内容
本发明提供了一种治疗心绞痛的药物组合物,该药物组合物疗效确切,毒副作用小,配合西药治疗冠心病引起的心绞痛,能显著提高治愈率;另一方面发明人还公开了该药物组合物的制备方法及用途。
具体来说:本发明发明人通过临床试验验证发现,将中药材熟地黄,黄精,柴胡,白芍,郁金,山楂,牛黄,半夏,细辛,草乌头,山杜仲,茯苓进行配伍得到的药物组合物,具有补气养血,化瘀祛痰,宣痹通络的显著功效,能够起到扩张冠状动脉、降低心肌耗氧量、抑制血小板聚集、抗炎、调脂的作用,配合西药治疗冠心病引起的心绞痛,能显著提高治愈率,改善患者肉体痛苦和经济负担,值得临床推广应用。
为了实现上述目的,优选地,上述组合物由下述重量配比的中药材制成:熟地黄15-20份,黄精10-14份,柴胡10-14份,白芍6-10份,郁金6-10份,山楂8-12份,牛黄2-6份,半夏8-12份,细辛3-5份,草乌头1-3份,山杜仲8-12份,茯苓10-14份。
进一步优选地,所述组合物由下述重量配比的中药材制成:熟地黄17份,黄精12份,柴胡12份,白芍8份,郁金8份,山楂10份,牛黄4份,半夏10份,细辛4份,草乌头2份,山杜仲10份,茯苓12份。
本发明所述组合物各组分的功能主治如下:
熟地黄,甘,微温。归肝、肾经。滋阴补血,益精填髓。用于肝肾阴虚,腰膝酸软,骨蒸潮热,盗汗遗精,内热消渴,血虚萎黄,心悸怔忡,月经不调,崩漏下血,眩晕,耳鸣,须发早白。
黄精,甘,平。归脾、肺、肾经。补气养阴,健脾,润肺,益肾。用于脾胃虚弱,体倦乏力,口干食少,肺虚燥咳,精血不足,内热消渴。
柴胡,苦,微寒。归肝、胆经。和解表里,疏肝,升阳。用于感冒发热,寒热往来,胸胁胀痛,月经不调,子官脱垂,脱肛。其中柴胡皂甙具有降血脂作用。
白芍,苦、酸,微寒。归肝、脾经。平肝止痛,养血调经,敛阴止汗。用于头痛眩晕,胁痛,腹痛,四肢挛痛,血虚萎黄,月经不调,自汗,盗汗。
郁金,辛、苦,寒。归肝、心、肺经。行气化瘀,清心解郁,利胆退黄。用于经闭痛经,胸腹胀痛、刺痛,热病神昏,癫痫发狂,黄疸尿赤。
山楂,酸、甘、微温。归脾、胃、肝经。消食健胃,行气散瘀。用于肉食积滞,胃脘胀满,泻痢腹痛,瘀血经闭,产后瘀阻,心腹刺痛,疝气疼痛;高脂血症。焦山楂消食导滞作用增强。用于肉食积滞,泻痢不爽。药理研究发现,服用山楂三周,血清胆固醇显著下降。
牛黄,甘,凉。归心、肝经。清心,豁痰,开窍,凉肝,息风,解毒。用于热病神昏,中风痰迷,惊痫抽搐,癫痫发狂,咽喉肿痛,口舌生疮,痈肿疔疮。
半夏,辛,温;有毒。归脾、胃、肺经。燥湿化痰,降逆止呕,消痞散结。用于痰多咳喘,痰饮眩悸,风痰眩晕,痰厥头痛,呕吐反胃,胸脘痞闷,梅核气;生用外治痈肿痰核。姜半夏多用于降逆止呕。
细辛,辛,温。归心、肺、肾经。祛风散寒,通窍止痛,温肺化饮。用于风寒感冒,头痛,牙痛,鼻塞鼻渊,风湿痹痛,痰饮喘咳。具有降脂的作用。
草乌头,辛,热,有毒。入肝、脾、肺经。搜风胜湿,散寒止痛,开痰,消肿。治风寒湿痹,中风瘫痪,破伤风,头风,脘腹冷痛,痰癖,气块,冷痢,喉痹,痈疽,疔疮,瘰疬。具有强心的作用。
山杜仲,甘;辛;微温;肝;肾;脾经;祛风湿;强筋骨;活血解毒;利水。主风湿痹痛;腰膝酸软;跌打骨折;疮疡肿毒;慢性肝炎;慢性肾炎;水肿。
茯苓,甘、淡,平。归心、肺、脾、肾经。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。
本发明提供的治疗心绞痛的药物组合物,可以根据需要制成各种剂型,优选的是,本发明药物组合物制成口服制剂,例如所述口服制剂可以为口服液、颗粒剂或胶囊剂,最优选的是,本发明药物组合物制成胶囊剂。本发明的发明人在研究中还发现,通过优化制备方法,可以降低药物所产生的副作用,且制备成优选的口服制剂,降低了口感的不足,进一步增加了患者使用该药物的依从性。
本发明提供的该药物组合物的制备方法,包括以下步骤:将处方量的中药材分别粉碎成粗粉,混合均匀,加入4-8倍量水,温浸1小时,煎煮3小时,煎煮两次,滤过,合并两次滤液,滤液浓缩至65℃时,其相对密度为1.10-1.15的浓缩液,放置6小时后加入乙醇至含醇量为所述全部中药原料药的65%,静置24小时,取上清液,回收乙醇,滤液浓缩至65℃测定的相对密度为1.26-1.31的稠膏,加入药学上可接受的载体,用常规方法制备成临床可以接受的剂型。
上述方法制得的药物组合物有效活性成分高,并且安全、无毒副作用。
本发明相对于现有技术具有预料不到的技术效果,其特征和优点将在随后的具体实施方式部分予以详细说明。
具体实施方式
本发明是通过以下具体实施方案实现的,但所描述的具体实施方式仅用于说明和解释本发明,并不用于限制本发明。
实施例1胶囊剂
本发明的治疗心绞痛的药物组合物由以下重量份药材制成:熟地黄17份,黄精12份,柴胡12份,白芍8份,郁金8份,山楂10份,牛黄4份,半夏10份,细辛4份,草乌头2份,山杜仲10份,茯苓12份。
制备工艺:将处方量的中药材分别粉碎成粗粉,混合均匀,加入4-8倍量水,温浸1小时,煎煮3小时,煎煮两次,滤过,合并两次滤液,滤液浓缩至65℃时,其相对密度为1.10-1.15的浓缩液,放置6小时后加入乙醇至含醇量为所述全部中药原料药的65%,静置24小时,取上清液,回收乙醇,滤液浓缩至65℃测定的相对密度为1.26-1.31的稠膏,加入药学上可接受的载体,用常规方法制备成胶囊剂。
使用本发明中药制剂治疗心绞痛时,服用所制备的胶囊剂,每粒含生药量0.25g,每日3次,每次3-4粒,饭后半小时服用。
实施例2颗粒剂
本发明的治疗心绞痛的药物组合物由以下重量份药材制成:熟地黄17份,黄精12份,柴胡12份,白芍8份,郁金8份,山楂10份,牛黄4份,半夏10份,细辛4份,草乌头2份,山杜仲10份,茯苓12份。
制备工艺:将处方量的中药材分别粉碎成粗粉,混合均匀,加入4-8倍量水,温浸1小时,煎煮3小时,煎煮两次,滤过,合并两次滤液,滤液浓缩至65℃时,其相对密度为1.10-1.15的浓缩液,放置6小时后加入乙醇至含醇量为所述全部中药原料药的65%,静置24小时,取上清液,回收乙醇,滤液浓缩至65℃测定的相对密度为1.26-1.31的稠膏,加入药学上可接受的载体,用常规方法制备成颗粒剂。
使用本发明中药制剂治疗心绞痛时,服用所制备的颗粒剂,每袋含生药量1g,每日3次,每次1袋,饭后半小时服用。
实施例3口服液
本发明的治疗心绞痛的药物组合物由以下重量份药材制成:熟地黄17份,黄精12份,柴胡12份,白芍8份,郁金8份,山楂10份,牛黄4份,半夏10份,细辛,4份,草乌头2份,山杜仲10份,茯苓12份。
制备工艺:将处方量的中药材分别粉碎成粗粉,混合均匀,加入4-8倍量水,温浸1小时,煎煮3小时,煎煮两次,滤过,合并两次滤液,滤液浓缩至65℃时,其相对密度为1.10-1.15的浓缩液,放置6小时后加入乙醇至含醇量为所述全部中药原料药的65%,静置24小时,取上清液,回收乙醇,滤液浓缩至65℃测定的相对密度为1.26-1.31的稠膏,加入药学上可接受的载体,用常规方法制备成口服液。
使用本发明中药制剂治疗心绞痛时,服用所制备的口服液,每瓶含生药量1g,每日3次,每次1瓶,饭后半小时服用。
实施例4胶囊剂
本发明的治疗心绞痛的药物组合物由以下重量份药材制成:熟地黄15份,黄精10份,柴胡10份,白芍6份,郁金6份,山楂8份,牛黄2份,半夏8份,细辛3份,草乌头1份,山杜仲8份,茯苓10份。
制备方法同实施例1。
实施例5胶囊剂
本发明的治疗心绞痛的药物组合物由以下重量份药材制成:熟地黄20份,黄精14份,柴胡14份,白芍10份,郁金10份,山楂12份,牛黄6份,半夏12份,细辛5份,草乌头3份,山杜仲12份,茯苓14份。
制备方法同实施例1。
对比实施例1胶囊剂
一种治疗心绞痛的药物组合物由以下重量份药材制成:熟地黄22份,黄精12份,柴胡12份,白芍8份,郁金10份,山楂10份,牛黄4份,半夏10份,细辛8份,草乌头2份,山杜仲4份,茯苓12份。
制备方法同实施例1。
对比实施例2胶囊剂
一种治疗心绞痛的药物组合物由以下重量份药材制成:熟地黄17份,黄精12份,柴胡12份,红花8份,郁金8份,牛黄4份,半夏10份,细辛4份,草乌头2份,山杜仲10份,茯苓12份。
制备方法同实施例1。
本发明的药物组合物胶囊剂用于临床观察试验
1.一般资料:
将我院2013年6月至2014年6月期间收治的200例痰浊闭阻型冠心病心绞痛患者做为观察治疗对象,随机分为对照1组、对照2组、对照3组和观察组各50例,所有患者均根据症状、体征、病史、心电图确诊,均符合《缺血性心脏病命名及诊断标准》中关于冠心病心绞痛的诊断标准,也符合痰浊闭阻型冠心病心绞痛的中医辩证标准。
其中,对照1组50例:男27例,女23例,年龄45-75岁,平均(52.4±8.6)岁,病程3月-12年,平均(5.8±1.6)年;对照2组50例:男25例,女25例,年龄40-76岁,平均(50.2±7.5)岁;病程2月-15年,平均(7.1±1.8)年;对照3组50例:男26例,女24例,年龄43-75岁,平均(49.8±6.5)岁;病程3月-14年,平均(6.5±1.6)年;观察组50例:男26例,女24例;年龄46-79岁,平均(51.8±7.6)岁,病程1月-16年,平均(6.4±1.3)年。四组性别、年龄、病程等方面经统计学处理,无显著性意义(P>0.05),具有可比性。
2.中医辩证标准:痰浊闭阻型冠心病心绞痛证见:胸中窒闷、喘促气短、恶心纳差、舌质淡红、苔白腻或黄腻、脉滑或弦滑。
3.治疗方法:
对照1组:口服40mg单硝酸异山梨酯缓释胶囊,每日1次,定时服用;
对照2组:在对照1组的基础上,同时口服对比实施例1制备的胶囊剂,每粒含生药量0.25g,每日3次,每次3-4粒,饭后半小时服用;
对照3组:在对照1组的基础上,同时口服对比实施例2制备的胶囊剂,每粒含生药量0.25g,每日3次,每次3-4粒,饭后半小时服用;
观察组:在对照1组的基础上,同时口服实施例1制备的胶囊剂,每粒含生药量0.25g,每日3次,每次3-4粒,饭后半小时服用。
四组患者的治疗均为一月一个疗程,一个疗程后观察治疗效果。
4.疗效标准:
显效:临床症状消失或基本消失,心电图检查恢复正常或大致正常。
有效:临床症状明显减轻,心电图检查降低的ST段回升0.5mV以上,主要导联倒立的T波变浅25%以上或T波由平坦变为直立。
无效:临床症状无改善,心电图检查无改变。
5.统计学方法
用统计学软件SPSS20.0对数据进行统计学分析,计数资料采用x2检验;计量资料用均数±标准差表示,进行t检验;P<0.05表示两组之间差异性显著。
6.治疗结果
(1)一个疗程后,观察组总有效率94%,显效率52%;对照1组总有效率70%,显效率36%;对照2组总有效率74%,显效率40%;对照2组总有效率70%,显效率38%;观察组的总有效率和显效率明显优于对照1组、对照2组和对照3组,且差异显著,具有统计学意义(P<0.05)。具体治疗效果见表1。
(2)一个疗程后,四组患者的心绞痛级别、脉搏、血压的改善情况见表2。通过比较可以发现观察组治疗后心绞痛级别、脉搏、血压较治疗前明显改善(P<0.05),并且变化情况均优于对照1组、对照2组和对照3组,且差异显著,具有统计学意义(P<0.05)。
表1.四组治疗结果对比
组别 | n | 显效 | 有效 | 无效 | 总有效率% |
观察组 | 50 | 26 | 21 | 3 | 94% |
对照1组 | 50 | 18 | 17 | 15 | 70% |
对照2组 | 50 | 20 | 17 | 13 | 74% |
对照3组 | 50 | 19 | 16 | 15 | 70% |
表2.四组心绞痛级别、脉搏、血压的改善情况
特别的是,通过对比观察组与对照2组、对照3组可以发现,随意改变组方组成及配比,不能达到本发明的治疗效果,且差异显著,具有统计学意义(P<0.05),表明本发明组方是严谨的,是经过长期试验观察得到的最佳组方及配比。
Claims (8)
1.一种治疗心绞痛的药物组合物,其特征在于,它由以下药物组成:熟地黄,黄精,柴胡,白芍,郁金,山楂,牛黄,半夏,细辛,草乌头,山杜仲,茯苓。
2.根据权利要求1所述的药物组合物,其特征在于,所述组合物由下述重量配比的中药材制成:熟地黄15-20份,黄精10-14份,柴胡10-14份,白芍6-10份,郁金6-10份,山楂8-12份,牛黄2-6份,半夏8-12份,细辛3-5份,草乌头1-3份,山杜仲8-12份,茯苓10-14份。
3.根据权利要求1所述的药物组合物,其特征在于,所述组合物由下述重量配比的中药材制成:熟地黄17份,黄精12份,柴胡12份,白芍8份,郁金8份,山楂10份,牛黄4份,半夏10份,细辛4份,草乌头2份,山杜仲10份,茯苓12份。
4.根据权利要求1-3所述的药物组合物,其特征在于,该药物组合物的剂型为口服液、颗粒剂、胶囊剂。
5.根据权利要求4所述的药物组合物,其特征在于,该药物组合物的剂型优选为胶囊剂。
6.一种制备权利要求1-3任一所述的药物组合物的方法,其特征在于,该方法包括以下步骤:将处方量的中药材分别粉碎成粗粉,混合均匀,加入4-8倍量水,温浸1小时,煎煮3小时,煎煮两次,滤过,合并两次滤液,滤液浓缩至65℃时,其相对密度为1.10-1.15的浓缩液,放置6小时后加入乙醇至含醇量为所述全部中药原料药的65%,静置24小时,取上清液,回收乙醇,滤液浓缩至65℃测定的相对密度为1.26-1.31的稠膏,加入药学上可接受的载体,用常规方法制备成临床可以接受的剂型。
7.如权利要求1-3所述的药物在制备治疗心绞痛的药物中的用途。
8.如权利要求1-3所述的药物在制备治疗由冠心病引起的痰浊闭阻型心绞痛的药物中的用途。
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