CN115282229B - 一种治疗气虚血淤型冠心病的中药组合物及其制备方法 - Google Patents
一种治疗气虚血淤型冠心病的中药组合物及其制备方法 Download PDFInfo
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Abstract
本发明涉及一种治疗气虚血淤型冠心病的中药组合物,由以下重量份的中药组合物组成:丹参18‑22、赤芍8‑10、川芎9‑12、红花9‑12、苏合香0.1、冰片0.2、当归8‑10、桃仁9‑12、枳壳9‑10、黄芪8‑10、柴胡3‑5、甘草1、桔梗3‑5、牛膝3‑5、薤白3‑5、延胡索3‑5、檀香3‑5和蒲黄3‑5。本发明制备方法主要是制胶囊和制膏药,两者配合使用,本发明的有效率97%以上,使用后症状改善明显,无毒副作用。
Description
技术领域
本发明涉及中医药技术领域,具体涉及一种治疗气虚血淤型冠心病的中药组合物及其制备方法。
背景技术
在老年人常见的心血管疾病中,气虚血瘀型冠心病的症状一直是最常见且极其有害的。患有气滞血瘀型冠心病,这种病变属于中医诊断,在病变发作时会出现胸痛、舌质紫暗等症状,这种病变在治疗时,可以给予血化瘀、行气止痛的药物治疗。
中国专利CN103784820A公开了一种用于治疗心血瘀阻型冠心病的中药配方及中药胶囊,其按质量份数计,由丹参、银杏叶、延胡索、川芎、麦芽、牡丹皮、山楂、人参、桃仁、藏红花、赤芍、鸡血藤、枳壳、陈皮、刘寄奴、甘草、当归、生地、柴胡、降香、白芍、薤白、桔梗、通草、五灵脂、桂枝、玉竹、三七、苏合香以及冰片组成。具有活血化瘀、通脉止痛等作用,治愈率在90%以上。同时,该中药配方可以缓解或治愈可诱发心血瘀阻型冠心病的高血压、高血脂。
中国专利CN104758438A一种治疗瘀阻心脉型冠心病的中药组合物,由以下重量份原料组成:3-11份当归,3-11份生地,10-18份桃仁,2-10份红花,2-10份枳壳,2-10份赤芍,1-9份柴胡,1-9份甘草,4-12份桔梗,4-12份川芎,8-16份牛膝,25-33份丹参,18-26份益母草,1-9份田七末,5-13份赤芍,5-13份白芍,6-14份茯苓,4-12份木香。本发明的功效为通过活血化瘀、通脉宣淤,主治心胸疼痛绞剧,如刺如绞,痛连肩背或两臂,伴有胸闷,唇甲青紫,心悸不宁,舌质紫暗或有瘀斑瘀点,脉弦涩或结代。
上述药物主要功效是活血化瘀,如果内服,并不能直接达到淤结点,难以达到药到病除的功效。
发明内容
本发明的目的是提供一种能够直接达到心前区部位,治疗效果佳的治疗气虚血淤型冠心病的中药组合物及其制备方法。
本发明的技术方案:
一种治疗气虚血淤型冠心病的中药组合物,由以下重量份的中药组合物组成:丹参18-22、赤芍8-10、川芎9-12、红花9-12、苏合香0.1、冰片0.2、当归8-10、桃仁9-12、枳壳9-10、黄芪8-10、柴胡3-5、甘草1、桔梗3-5、牛膝3-5、薤白3-5、延胡索3-5、檀香3-5和蒲黄3-5。
优选的,由以下重量份的中药组合物组成:丹参20、赤芍9、川芎11、红花10、苏合香0.1、冰片0.2、当归9、桃仁11、枳壳9、黄芪10、柴胡4、甘草1、桔梗4、牛膝4、薤白4、延胡索4、檀香4和蒲黄4。
优选的,由以下重量份的中药组合物组成:丹参21、赤芍8、川芎12、红花10、苏合香0.1、冰片0.2、当归10、桃仁10、枳壳10、黄芪9、柴胡4、甘草1、桔梗4、牛膝4、薤白4、延胡索4、檀香4和蒲黄4。
优选的,还包括五灵脂3-5和桂枝3-5。
优选的,还包括五灵脂4和桂枝4。
优选的,一种治疗气虚血淤型冠心病的中药组合物的制备方法,包括以下步骤:
(1)将黄芪、桔梗、檀香、蒲黄磨粉,过100-150目筛;
(2)将丹参、赤芍、川芎、红花、当归、桃仁、枳壳、柴胡、甘草、牛膝、薤白、延胡索加入上述药物重量8-12倍水文火煮沸,沸后1-2小时凉至室温,过滤,滤液保留;滤渣中加入上一步相同重量的水文火煮沸,沸后1-2小时凉至室温,过滤,得到滤液,将两次滤液合并,得到合并液;
(3)将步骤(2)得到的合并液在真空度为0.07-0.09MPa,45-50℃条件下减压浓缩至相对密度为1.3-1.4的稠膏,将苏合香溶于稠膏中,将稠膏分成两均份,其中一份加入步骤(1)中细粉搅拌均匀,干燥;
(4)向步骤(3)剩余的另一份稠膏中加入冰片混匀,制成膏药贴。
优选的,一种治疗气虚血淤型冠心病的中药组合物的制备方法,包括以下步骤:
(1)将黄芪、桔梗、檀香、蒲黄、五灵脂磨粉,过100-150目筛;
(2)将丹参、赤芍、川芎、红花、当归、桃仁、枳壳、柴胡、甘草、牛膝、薤白、延胡索、桂枝加入上述药物重量8-12倍水文火煮沸,沸后1-2小时凉至室温,过滤,滤液保留;滤渣中加入上一步相同重量的水文火煮沸,沸后1-2小时凉至室温,过滤,得到滤液,将两次滤液合并,得到合并液;
(3)将步骤(2)得到的合并液在真空度0.07-0.09MPa,45-50℃条件下减压浓缩至相对密度为1.3-1.4的稠膏,将苏合香溶于稠膏中,将稠膏分成两均份,其中一份加入步骤(1)中细粉搅拌均匀,干燥;
(4)向步骤(3)剩余的另一份稠膏中加入冰片混匀,制成膏药贴。
优选的,步骤(3)干燥后粉碎装胶囊。
丹参:丹参片是活血化瘀、理气止痛的中成药。主要用于心绞痛、高血压、颈椎病以及胸中憋闷等病症。
赤芍:具有清热凉血、散瘀止痛的功能。生赤芍以清热凉血力胜。多用于温病热入血分的身热出血,目赤肿痛,痈肿疮毒。
川芎:行气开郁,祛除风燥湿,活血止痛。治风冷头痛眩晕,胁痛腹疼,寒痹筋挛,经闭,难产,产后瘀阻块痛,痈疽疮疡。用于月经不调,经闭痛经,瘕腹痛,胸胁刺痛,跌扑肿痛,头痛,风湿痹痛。
红花:通经、活血。
苏合香:为刺激性祛痰药,并有较弱的抗菌作用,可用于各种呼吸道感染。本品有温和的刺激作用,用于局部可缓解炎症,如湿疹和瘙痒,并能促进溃疡与创伤的愈合。即使服较大剂量亦不产生蛋白尿。
冰片:开窍醒神、清热止痛,用于治疗热病神昏、惊厥、中风痰厥、气郁暴厥、中恶昏迷、胸痹心痛、目赤、口疮、咽喉肿痛、耳道流脓等。
当归:补血;活血;调经止痛;润燥滑肠。主血虚诸证;月经不调;经闭;痛经;症瘕结聚;崩漏;虚寒腹痛;痿痹;肌肤麻木;肠燥便难;赤痢后重;痈疽疮疡;跌扑损伤。桃仁:本品活血祛瘀作用亦较广泛,对上述瘀血阻滞病症,甚为常用。
枳壳:破气,行痰,消积。治胸膈痰滞,胸痞,胁胀,食积,噫气,呕逆,下痢后重,脱肛,子宫脱垂。
黄芪:黄芪有增强机体免疫功能、保肝、利尿、抗衰老、抗应激、降压和较广泛的抗菌作用。能消除实验性肾炎蛋白尿,增强心肌收缩力,调节血糖含量。黄芪不仅能扩张冠状动脉,改善心肌供血,提高免疫功能,而且能够延缓细胞衰老的进程。黄芪食用方便,可煎汤,煎膏,浸酒,入菜肴等。
柴胡:清虚热中药,用于感冒发热、寒热往来、疟疾、肝郁气滞、胸肋胀痛、脱肛、子宫脱落、月经不调。
甘草:用于心气虚,心悸怔忡,脉结代,以及脾胃气虚,倦怠乏力等。前者,常与桂枝配伍,如桂枝甘草汤、炙甘草汤。
桔梗:宣肺,利咽,祛痰,排脓。用于咳嗽痰多,胸闷不畅,咽痛,音哑,肺痈吐脓,疮疡脓成不溃。
牛膝:活血通经;治产后腹痛,月经不调,闭经,鼻衄,虚火牙痛,脚气水肿;熟用,补肝肾,强腰膝;治腰膝酸痛,肝肾亏虚,跌打瘀痛。
薤白:具有通阳散结、行气导滞的功效,主要用于胸痹证,本品能够辛散苦降、温通滑利,善散阴寒凝滞。治治疗痰瘀胸痹,常与丹参配伍。
延胡索:有活血散淤、利气止痛的功能,主治心腹腰膝疼痛、跌打损伤、淤血作痛、月经不调等症,是一味传统的止痛药。
檀香:理气,和胃。治心腹疼痛,噎膈呕吐,胸膈不舒。
蒲黄:止血,化瘀,通淋。用于吐血,衄血,咯血,崩漏,外伤出血,经闭痛经,脘腹刺痛,跌扑肿痛,血淋涩痛。
薤白:用于胸痹心痛,脘腹痞满胀痛,泻痢后重。
五灵脂:生用行血止痛。治心腹血气诸痛,妇女经闭,产后瘀血作痛;外治蛇、蝎、蜈蚣咬伤。炒用止血。
用法用量:
一粒胶囊0.3g,每次直接服用2粒胶囊,一日三次饭后服用,忌饮酒和辛辣刺激的食物。膏药贴的重量为15-18g,膏药直径10cm,睡前用一贴,贴于心前区部位,贴1-2小时撕掉即可。
膏药配合胶囊连续服用30日为一个疗程。
孕妇和经期女性禁服。
本发明的有益效果:
本发明选择具有良好的透皮吸收功能,能通过皮肤进入到血液发挥药效的中药,用此类药物制作成膏药贴于心前区部位,以起到治疗效果,作用效果好。本发明膏药配合使用胶囊或者颗粒,内外协治,能够迅速达到患病部位,且本申请的药物以丹参为主药,为了配合主药达到最佳的功效,本申请结合赤芍、川芎、红花、当归、桃仁、枳壳、柴胡、甘草、牛膝、薤白、延胡索发挥协同作用,同时配合使用,配薤白辛温通阳,宽胸散结,共为辅药。佐以桂枝,既助薤白温通胸阳,又能温里而降冲气,佐以五灵脂,行气导滞。本发明中的冰片主要是用在膏药贴中,能够起到开窍醒神、清热止痛的功效,且味道能够被人体吸入直达心肺,治疗胸痹心痛,达到提神,改善精神状态的功效,也可直接通过皮肤吸收,要比淡出的口服效果好。
本发明的有效率97%以上,使用后症状改善明显,无毒副作用。
具体实施方式
实施例1
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实施例2
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实施例3
单位:份
实施例4
单位:份
实施例5
单位:份
实施例6
单位:份
实施例7
单位:份
实施例1-4的制备方法为:
一种治疗气虚血淤型冠心病的中药组合物的制备方法,包括以下步骤:
(1)将黄芪、桔梗、檀香、蒲黄磨粉,过100-150目筛;
(2)将丹参、赤芍、川芎、红花、当归、桃仁、枳壳、柴胡、甘草、牛膝、薤白、延胡索加入上述药物重量8-12倍水文火煮沸,沸后1-2小时凉至室温,过滤,滤液保留;滤渣中加入上一步相同重量的水文火煮沸,沸后1-2小时凉至室温,过滤,得到滤液,将两次滤液合并,得到合并液;
(3)将步骤(2)得到的合并液在真空度0.07-0.09MPa,45-50℃条件下减压浓缩至相对密度为1.3-1.4的稠膏,将苏合香溶于稠膏中,将稠膏分成两均份,其中一份加入步骤(1)中细粉搅拌均匀,干燥,粉碎成粉末;粉末装胶囊,每粒胶囊0.3g;
(4)向步骤(3)剩余的另一份稠膏中加入冰片混匀,制成膏药贴。
实施例5-7的制备方法为:
一种治疗气虚血淤型冠心病的中药组合物的制备方法,包括以下步骤:
(1)将黄芪、桔梗、檀香、蒲黄、五灵脂磨粉,过100-150目筛;
(2)将丹参、赤芍、川芎、红花、当归、桃仁、枳壳、柴胡、甘草、牛膝、薤白、延胡索、桂枝加入上述药物重量8-12倍水文火煮沸,沸后1-2小时凉至室温,过滤,滤液保留;滤渣中加入上一步相同重量的水文火煮沸,沸后1-2小时凉至室温,过滤,得到滤液,将两次滤液合并,得到合并液;
(3)将步骤(2)得到的合并液在0.07-0.09MPa,45-50℃条件下减压浓缩至相对密度为1.3-1.4的稠膏,将苏合香溶于稠膏中,将稠膏分成两均份,其中一份加入步骤(1)中细粉搅拌均匀,干燥粉碎成粉末,装胶囊,每粒胶囊0.3g;
(4)向步骤(3)剩余的另一份稠膏中加入冰片混匀,制成膏药贴。
动物实验
选取体重为180±20的雄性白鼠50只,按照体重随机分为五组,每组10只,分别为白鼠一组、白鼠二组、白鼠三组、白鼠四组和白鼠五组,连续喂服本发明实施例1、2、5、6的粉末,溶在水中强制服用,分三次服用;白鼠一组每次灌服实施例1粉末60mg,且贴直径1cm的膏药贴,每天贴在白鼠心前区部位,贴2小时后撕掉;白鼠二组每次灌服实施例2的粉末120mg,且贴直径1cm的膏药贴,每天贴在白鼠心前区部位,贴2小时后撕掉;白鼠三组每次灌服实施例3的粉末60mg,且贴直径1cm的膏药贴,每天贴在白鼠心前区部位,贴2小时后撕掉;
白鼠四组每次灌服实施例4的粉末60mg,且贴直径1cm的膏药贴,每天贴在白鼠心前区部位,贴4小时后撕掉;白鼠五组灌相同重量的水;正常喂食,连续用药90天后,五组雄性白鼠均生长良好,未发现大鼠的心、肝、肺、肾有毒理性病变。但是前四组平均重量较第五组雄性白鼠增重10%-15%,白鼠四组较白鼠五组雄性白鼠食用量多13-20%,这是由于本发明实施例中有活血部分,能够促进血液循环,增强雄性白鼠的消化吸收能力。
临床试验病例
1、病例
共收治气虚血淤型冠心病病人345例,其中女性170例,男性175例,年龄35-67岁;
2、诊断标准:
(1)西医诊断标准(参照国际心脏病学会和协会及世界卫生组织临床命名标准化联合专题组报告《缺血性心脏病的命名及诊断档准》)分为劳累性心绞痛,自发性心绞痛。
(2)中医证候诊断标准(参照GB《中医临床诊疗术语证候部分》)1997-03-04发布及高等医药院校教材《中医内科学》上海科技出版社,1985年10月,第一版)分为心血瘀阻证、气滞血瘀证、痰阻心脉证、阴寒凝滞证、气阴两虚证。
3、治疗和疗效判断
第一组
34例女性,35例男性分别服用本发明实施例1,每次温水吞服2粒胶囊,一日三次饭后服用,忌饮酒和辛辣刺激的食物。
膏药贴的重量为15-18g,药膏直径10cm,睡前用一贴,贴于心前区部位,贴1-2小时撕掉即可。
膏药配合胶囊连续服用30日为一个疗程。
第二组
34例女性,35例男性服用本发明实施例1,每次温水吞服0.6g粉末,每粒胶囊里面含有300mg的粉末,一日三次饭后服用,忌饮酒和辛辣刺激的食物。
膏药贴的重量为15-18g,膏药的直径10cm,睡前用一贴,贴于心前区部位,贴1-2小时撕掉即可。
膏药配合粉末连续服用30日为一个疗程。
第三组
34例女性,35例男性分别服用本发明实施例5,每次温水吞服2粒胶囊,一日三次饭后服用,忌饮酒和辛辣刺激的食物。
膏药贴的重量为15-18g,膏药直径10cm,睡前用一贴,贴于心前区部位,贴1-2小时撕掉即可。
膏药配合制粒连续服用30日为一个疗程。
第四组
34例女性,35例男性分别服用本发明实施例1,每次温水吞服2粒胶囊,一日三次饭后服用,忌饮酒和辛辣刺激的食物。连续服用30日为一个疗程。
第五组
34例女性,35例男性分别服用对比药物,每次温水吞服2粒胶囊,一日三次饭后服用,忌饮酒和辛辣刺激的食物。连续服用30日为一个疗程。
第五组服用的药物有效成分重量份组成为:丹参215、赤芍100、川芎115、红花110、玉竹110、三七40、人参22、苏合香9、冰片2.2;制备方法:(1)将三七、川芎、人参粉碎成细粉,过80-100目筛;(2)将丹参、赤芍、红花、玉竹加水煎煮二次,每次2-3小时,合并滤液,在真空度0.06-0.08MPa、50-60℃条件下,减压浓缩至在40-50℃温度下测得的相对密度为1.35-1.45的稠膏,将苏合香溶于稠膏中;(3)将川芎、三七、人参细粉与上述稠膏混匀,制成颗粒干燥;(4)将冰片兑入颗粒中混匀,将颗粒装胶囊,每个胶囊中装有0.3g的颗粒。
疗效判定:
显效:临床症状,体征明显改善,心绞痛等主要症状消失或达到显效标准,心电图恢复至正常心电图或达到大致正常。
有效:临床症状,体征均有好转,心绞痛等主要症状减轻或达到有效标准,心电图恢改善达到有效标准。
无效:临床症状,体征无明显改善,甚至加重,心绞痛等主要症状无改善或加重,心电图基本与治疗前相同,甚至加重。
治疗效果:
显效 | 有效 | 无效 | 有效率 | |
第一组 | 62.31%(43例) | 34.78%(24例) | 2.90%(2例) | 97.10% |
第二组 | 60.87%(42例) | 36.23%(25例) | 2.90%(2例) | 97.10% |
第三组 | 65.22%(45例) | 31.88%(22例) | 2.90%(2例) | 97.10% |
第四组 | 52.70%(36例) | 34.78%(24例) | 13.04%(9例) | 86.96% |
第五组 | 50.72%(35例) | 43.47%(30例) | 5.80%(4例) | 94.20% |
通过治疗效果表明本发明有着良好的有效率,高达97.10%(第一至三组),粉末和胶囊对药效的影响不显著(第一组和第二组对比),添加了五灵脂和桂枝(第三组和第一组对比)后显效率明显增加,且本申请膏药贴和胶囊要配合使用效果才佳,单用一样效果明显打折(第一组和第四组对比),通过和之前的药物(第一组和第五组的对比)比较,本发明药物能够明显增强显效率,且整体的有效率也增强,本发明能够明显提高人体血液循环,增强食欲,改善睡眠,精神状态得到明显的好转。
以上所述,仅是本发明的较佳实施例而已,并非对本发明作任何形式上的限制,虽然本发明已以较佳实施例揭示如上,然而并非用以限定本发明,任何本领域技术人员,在不脱离本发明技术方案范围内,当可利用上述揭示的技术内容做出些许更动或修饰为等同变化的等效实施例,但凡是未脱离本发明技术方案内容,依据本发明的技术实质对以上实施例所作的任何简介修改、等同变化与修饰,均仍属于本发明技术方案的范围内。
Claims (1)
1.一种治疗气虚血淤型冠心病的中药组合物,其特征在于,由以下重量份的中药组成:丹参18-22、赤芍8-10、川芎9-12、红花9-12、苏合香0.1、冰片0.2、当归8-10、桃仁9-12、枳壳9-10、黄芪8-10、柴胡3-5、甘草1、桔梗3-5、牛膝3-5、薤白3-5、延胡索3-5、檀香3-5和蒲黄3-5、五灵脂3-5和桂枝3-5,具体制备步骤为:
(1)将黄芪、桔梗、檀香、蒲黄、五灵脂磨粉,过100-150目筛;
(2)将丹参、赤芍、川芎、红花、当归、桃仁、枳壳、柴胡、甘草、牛膝、薤白、延胡索、桂枝加入上述药物重量8-12倍水文火煮沸,沸后1-2小时凉至室温,过滤,滤液保留;滤渣中加入上一步相同重量的水文火煮沸,沸后1-2小时凉至室温,过滤,得到滤液,将两次滤液合并,得到合并液;
(3)将步骤(2)得到的合并液在真空度0.07-0.09MPa,45-50℃条件下减压浓缩至相对密度为1.3-1.4的稠膏,将苏合香溶于稠膏中,将稠膏分成两均份,其中一份加入步骤(1)中细粉搅拌均匀,干燥,干燥完毕后粉碎装胶囊;
(4)向步骤(3)剩余的另一份稠膏中加入冰片混匀,制成膏药贴。
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