CN103893706B - 一种治疗冠心病的中药制剂及制备方法 - Google Patents
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Abstract
本发明公开了一种治疗冠心病的中药制剂及制备方法，属中药领域；本发明中药制剂有效成分的原料组成为：柏子仁、槐花、荜拔、白芍药、莲子、龙骨、刘寄奴、苦菜、鸡血藤、海木、狐心、合欢皮、相思藤、银耳、丹参和郁金；本发明中药制剂所选药材配伍相宜，符合中医药学和现代医药学理论，并具有解郁安神、活血消肿、活血舒筋之功效，能够改善血管内皮功能，解除血管痉挛，抗击动脉硬化，稳定易损斑块，治愈后不复发，安全无副作用，成本低廉，能够达到标本兼治的目的，对治疗冠心病具有显著的疗效，值得临床上广泛推广应用。
Description
所属技术领域
本发明涉及中药领域，尤其涉及一种治疗冠心病的中药制剂及制备方法。
背景技术
冠状动脉粥样硬化性心脏病是冠状动脉血管发生动脉粥样硬化病变而引起血管腔狭窄或阻塞，造成心肌缺血、缺氧或坏死而导致的心脏病，常常被称为“冠心病”。但是冠心病的范围可能更广泛，还包括炎症、栓塞等导致管腔狭窄或闭塞。世界卫生组织将冠心病分为5大类：无症状心肌缺血、心绞痛、心肌梗死、缺血性心力衰竭和猝死5种临床类型。临床中常常分为稳定性冠心病和急性冠状动脉综合征。
冠心病典型胸痛因体力活动、情绪激动等诱发，突感心前区疼痛，多为发作性绞痛或压榨痛，也可为憋闷感。疼痛从胸骨后或心前区开始，向上放射至左肩、臂，甚至小指和无名指，休息或含服硝酸甘油可缓解。胸痛放散的部位也可涉及颈部、下颌、牙齿、腹部等。胸痛也可出现在安静状态下或夜间，由冠脉痉挛所致，也称变异型心绞痛。如胸痛性质发生变化，如新近出现的进行性胸痛，痛阈逐步下降，以至稍事体力活动或情绪激动甚至休息或熟睡时亦可发作。疼痛逐渐加剧、变频，持续时间延长，祛除诱因或含服硝酸甘油不能缓解，此时往往怀疑不稳定心绞痛。
近年来上市的治疗冠心病的中药新药中多以活血化瘀，理气止痛疗法为主，临床研究表明，心肾虚弱为年高之人常见的病因病机，单施祛瘀活血唯恐伤正，而若以“滋肾养心”禹于之中，既防伤正之弊，又可增强心肾功能，更有助于活血化瘀，行气止痛。为研究这一药物，中药制剂已成为医学界的研究的重要线索之一。
发明内容
本发明提供了一种治疗冠心病的中药制剂及制备方法；本发明中药制剂所选药材配伍相宜，符合中医药学和现代医药学理论，并具有解郁安神、活血消肿、活血舒筋之功效，能够改善血管内皮功能，解除血管痉挛，抗击动脉硬化，稳定易损斑块，治愈后不复发，安全无副作用，成本低廉，能够达到标本兼治的目的，对治疗冠心病具有显著的疗效，值得临床上广泛推广应用。
为实现上述目的，本发明的技术方案实施如下：
一种治疗冠心病的中药制剂，制成所述中药制剂有效成分的原料组成及重量份数为：
柏子仁62～86份槐花61～85份荜拔61～85份白芍药57～81份
莲子56～80份龙骨55～79份刘寄奴55～79份苦菜51～75份
鸡血藤47～71份海木42～66份狐心39～63份合欢皮37～61份
相思藤37～61份银耳36～60份丹参32～56份郁金17～41份。
制成所述中药制剂有效成分的原料组成及重量份数为：
柏子仁66～82份槐花65～81份荜拔65～81份白芍药61～77份
莲子60～76份龙骨59～75份刘寄奴59～75份苦菜55～71份
鸡血藤51～67份海木46～62份狐心43～59份合欢皮41～57份
相思藤41～57份银耳40～56份丹参36～52份郁金21～37份。
制成所述中药制剂有效成分的原料组成及重量份数为：
柏子仁70～78份槐花69～77份荜拔69～77份白芍药65～73份
莲子64～72份龙骨63～71份刘寄奴63～71份苦菜59～67份
鸡血藤55～63份海木50～58份狐心47～55份合欢皮45～53份
相思藤45～53份银耳44～52份丹参40～48份郁金25～33份。
制成所述中药制剂有效成分的原料组成及重量份数为：
柏子仁74份槐花73份荜拔73份白芍药69份
莲子68份龙骨67份刘寄奴67份苦菜63份
鸡血藤59份海木54份狐心51份合欢皮49份
相思藤49份银耳48份丹参44份郁金29份。
一种治疗冠心病的中药制剂的制备方法，包括以下工艺步骤：
（1）将柏子仁、荜拔、白芍药、莲子、龙骨、刘寄奴、合欢皮、相思藤、银耳、丹参和郁金洗净，放入容器内，加入8～10倍量的蒸馏水，浸泡5～6小时后，煮沸3～4小时，提取；再次加入6～8倍量蒸馏水，煮沸2～3小时，提取；最后，加入4～6倍量蒸馏水，加热煮沸1～2小时，提取；合并三次提取液，过滤，得滤液，浓缩成60℃下相对密度为1.10～1.13的稠膏，备用；
（2）将槐花放入锅内，武火炒炒制至微黄，取出凉透，研末，过160目细粉，备用；
（3）将苦菜洗净，切碎，放入容器内，绞汁，滤杂质，留汁液备用；
（4）将鸡血藤和海木洗净，浸入5倍量的80%的乙醇溶液浸泡1～2小时，加热提取3小时，回收乙醇，滤过，得滤液，浓缩为65℃下相对密度为1.12～1.16的稠膏，备用；
（5）将狐心烘干放入容器内，进行粉碎处理，研末，过180目细粉，备用；
（6）将上述步骤（1）～（5）所制得的稠膏、细粉以及汁液混合，制成胶囊，即得本发明所述的治疗冠心病的中药制剂。
本发明所用中药的药性如下：
柏子仁：味甘，性平；归心、肾、大肠经。养心安神，止汗润肠。用于虚烦失眠，心悸怔忡，阴虚盗汗，肠燥便秘。《纲目》载：“养心气，润肾燥，益智宁神；烧沥治疥癣。”
槐花：味苦，性微寒；入肝、肺、心、大肠经。凉血止血，清肝明目。主治肠风便血，痔疮下血，血痢，尿血，血淋，崩漏，吐血，衄血，肝热头痛，目赤肿痛，痈肿疮疡。《本草正》载：“凉大肠，杀疳虫。治痈疽疮毒，阴疮湿痒，痔漏，解杨梅恶疮，下疳伏毒。”现代医学研究证实，槐花所含的芸香甙可增强毛细血管抵抗力，改善血管壁脆性，降低血压、抗水肿，对高血压有防止脑血管破裂的功效，此外还有抗炎作用。
荜拔：味辛，性热；归脾、胃经。温中散寒，下气止痛，醒脾开胃。用于胃寒引起的腹痛，呕吐，腹泻，冠心病心绞痛，神经性头痛及牙痛，昏倒，牙关紧闭，不省人事，苔白，脉迟，亦治心腹卒痛，昏厥，中风。
白芍药：味酸，微寒，有小毒。通顺血脉，缓中，散恶血，逐贼血，去水气，利膀胱，大小肠，消痈肿。主时行寒热，中恶，腹痛，腰痛。《药性论》载：“臣能治肺邪气，腹中绞痛，血气积聚，通宣脏腑拥气，治邪痛败血，主时疾骨热，强五脏，补肾气，治心腹坚胀，妇人血闭不通，消瘀血，能蚀脓。”现代医学研究证明，白芍药对人体心脑血管具有很好地保护和调养的作用，对人体中枢神经病痛有很好地治疗和抑制作用。
莲子：味甘、涩，性平；归脾、肾、心经。养心益肾，补脾涩肠。治夜寐多梦，遗精，淋浊，久痢，虚泻，妇人崩漏带下。石莲子并能止呕、开胃，常用治噤口痢。《纲目》载：“交心肾，厚肠胃，固精气，强筋骨，补虚损，利耳目，除寒湿，止脾泄久痢，赤白浊，女人带下崩中诸血病。”
龙骨：味甘、涩，性平，无毒；归心、肝、肾、大肠经。镇惊安神，平肝潜阳，固涩收敛。主治惊痫癫狂，心悸怔忡，失眠健忘，头晕目眩，自汗盗汗，遗精遗尿，崩漏带下，久泻久痢，溃疡久不收口及湿疮。《日华子本草》载：“健脾，涩肠胃，止泻痢，渴疾，怀孕漏胎，肠风下血，崩中带下，鼻洪，吐血，止汗。”
刘寄奴：味苦，性温；入心、脾经。破血通经，敛疮消肿。治经闭症瘕，胸腹胀痛，产后血瘀，跌打损伤，金疮出血，痈毒焮肿。《开宝本草》载：“疗金疮，止血为要药；产后余疾，下血、止痛。”现代医学研究证实，刘寄奴对宋内痢疾杆菌、志贺痢疾杆菌有杀菌作用，对福氏痢疾杆菌、鲍氏痢疾杆菌、大肠杆菌及变形杆菌有抑菌作用。
苦菜：味苦，性寒；入心、脾、胃三经。清热解毒，破瘀活血，排脓。用于阑尾炎，腹腔脓肿，肠炎，痢疾，急、慢性盆腔炎，肺热咳嗽，肺结核，吐血，衄血；外用治跌打损伤，疮疖肿痛，黄水疮，阴囊湿疹。
鸡血藤：味苦、微甘、性温；归肝、心、肾经。活血舒筋，养血调经。主治风湿痹痛，手足麻木，肢体瘫痪，月经不调，经行不畅，痛经，经闭，白细胞减少症。
海木：味苦，性凉，有小毒。清热解毒，祛风湿，利咽喉。主治风湿腰腿痛，咽喉炎，扁桃体炎，心胃气痛。
狐心：味甘，性平；归心、肾经。补虚安神，利尿消肿。主治精神失常，癫狂，水肿，腹水。
合欢皮：性平，味甘，无毒；归心、肝经。解郁安神，活血消肿。治心神不安，忧郁失眠，肺痈疮肿，跌扑伤痛等症。《纲目》载：“和血，消肿，止痛。”
相思藤：味甘，性凉，无毒；归肺、脾、肝经。生津，润肺，清热，利尿，主治喉痛，肝炎，支气管炎。《广西中草药》载：“清热利尿。治咽喉肿痛，肝炎，支气管炎。”
银耳：味甘、淡，性平，无毒；归肺、胃、肾经。滋补生津，润肺养胃。《珍珠囊》载：“足阳明胃、手阳明大肠、手太阴肺经。”现代医学研究证实，银耳中含有蛋白质、脂肪和多种氨基酸、矿物质及肝糖，属胶性真菌，富含硒等微量元素，有防辐射之功能，同时祛斑美容效果好，适用于五脏虚弱、气血不足、面色无华、毛发不泽。据研究，银耳能使人的新陈代谢增强，血液循环旺盛，各个组织器官的功能得到改善，皮肤的弹性增强，皮下组织丰满，皱纹变浅甚至消失，皮肤变得细嫩光滑。
丹参：味苦，性微寒；入心、肝经。排脓生肌，活血调经，祛瘀止痛，凉血消痈，清心除烦，养血安神。用于月经不调，瘀血作痛，闭经，症瘕，冠心病，心绞痛，子宫外孕，心烦内热，痈肿疮毒等。《药性论》载：“治脚弱，疼痹，主中恶；治腹痛，气作声音呜吼。”临床药理研究得知，丹参具有抗凝、抗血小板聚集的作用，能够调节血液粘稠度，改善血液流变学指数，增加毛细血管的通透性，促进纤维蛋白原的溶解，加速机体血液循环；此外，丹参可以有效地降低内皮素，改善心肌能量代谢，从而使胰腺组织的血流增多，避免缺血对胰腺组织造成的进一步损伤。
郁金：味辛、苦，性寒；归肝、心、肺经。行气化瘀，清心解郁，利胆退黄，活血止痛，行气解郁，清心凉血。用于经闭痛经，胸腹胀痛，刺痛，热病神昏，癫痫发狂，黄疸尿赤。《本草述》载：“治发热，郁，咳嗽，齿衄，咳嗽血，溲血，头痛眩晕，狂痫，滞下，并眼目鼻舌咽喉等证。”
本发明与现有技术相比，具有以下有益效果：
本发明中药制剂所选药材配伍相宜，符合中医药学和现代医药学理论，并具有解郁安神、活血消肿、活血舒筋之功效，能够改善血管内皮功能，解除血管痉挛，抗击动脉硬化，稳定易损斑块，治愈后不复发，安全无副作用，成本低廉，能够达到标本兼治的目的，对治疗冠心病具有显著的疗效，值得临床上广泛推广应用。
具体实施方式
下面结合具体实施例对本发明做进一步阐述。
实施例1
本发明中药制剂有效成分的原料组成及重量为：
柏子仁82g槐花81g荜拔81g白芍药77g
莲子76g龙骨75g刘寄奴75g苦菜71g
鸡血藤67g海木62g狐心59g合欢皮57g
相思藤57g银耳56g丹参52g郁金37g。
本发明中药制剂的制备方法，包括以下工艺步骤：
（1）将柏子仁、荜拔、白芍药、莲子、龙骨、刘寄奴、合欢皮、相思藤、银耳、丹参和郁金洗净，放入容器内，加入8～10倍量的蒸馏水，浸泡5～6小时后，煮沸3～4小时，提取；再次加入6～8倍量蒸馏水，煮沸2～3小时，提取；最后，加入4～6倍量蒸馏水，加热煮沸1～2小时，提取；合并三次提取液，过滤，得滤液，浓缩成60℃下相对密度为1.10～1.13的稠膏，备用；
（2）将槐花放入锅内，武火炒炒制至微黄，取出凉透，研末，过160目细粉，备用；
（3）将苦菜洗净，切碎，放入容器内，绞汁，滤杂质，留汁液备用；
（4）将鸡血藤和海木洗净，浸入5倍量的80%的乙醇溶液浸泡1～2小时，加热提取3小时，回收乙醇，滤过，得滤液，浓缩为65℃下相对密度为1.12～1.16的稠膏，备用；
（5）将狐心烘干放入容器内，进行粉碎处理，研末，过180目细粉，备用；
（6）将上述步骤（1）～（5）所制得的稠膏、细粉以及汁液混合，制成胶囊，即得本发明所述的治疗冠心病的中药制剂。
用法用量：口服，每日2次，早晚各1次，每次2粒（每粒0.5g)，饭后温开水送服；15天为1个疗程，2～4个疗程即可痊愈，病情严重者遵医嘱酌增用量。
实施例2
本发明中药制剂有效成分的原料组成及重量为：
柏子仁78g槐花77g荜拔77g白芍药73g
莲子72g龙骨71g刘寄奴71g苦菜67g
鸡血藤63g海木58g狐心55g合欢皮53g
相思藤53g银耳52g丹参48g郁金33g。
本实施例的中药制剂制备方法工艺步骤及用法用量与实施例1相同。
实施例3
本发明中药制剂有效成分的原料组成及重量为：
柏子仁74g槐花73g荜拔73g白芍药69g
莲子68g龙骨67g刘寄奴67g苦菜63g
鸡血藤59g海木54g狐心51g合欢皮49g
相思藤49g银耳48g丹参44g郁金29g。
本实施例的中药制剂制备方法工艺步骤及用法用量与实施例1相同。
实施例4
本发明中药制剂有效成分的原料组成及重量为：
柏子仁70g槐花69g荜拔69g白芍药65g
莲子64g龙骨63g刘寄奴63g苦菜59g
鸡血藤55g海木50g狐心47g合欢皮45g
相思藤45g银耳44g丹参40g郁金25g。
本实施例的中药制剂制备方法工艺步骤及用法用量与实施例1相同。
实施例5
本发明中药制剂有效成分的原料组成及重量为：
柏子仁66g槐花65g荜拔65g白芍药61g
莲子60g龙骨59g刘寄奴59g苦菜55g
鸡血藤51g海木46g狐心43g合欢皮41g
相思藤41g银耳40g丹参36g郁金21g。
本实施例的中药制剂制备方法工艺步骤及用法用量与实施例1相同。
临床资料：
1、病例选择：
作为治疗冠心病的中药制剂，选择确诊的冠心病患者304例临床观察，病人随机分成治疗组和对照组两组，治疗组152例，其中男性77例，女性75例，年龄41～74岁，平均年龄57.5岁，平均病程5.8年；对照组152例，其中男性76例，女性76例，年龄42～73岁，平均年龄57.5岁，平均病程5.6年。
治疗组和对照组两组病例的病程、症状轻重程度基本一致，无显著差异，具有可比性。
2、药物选择：
治疗组服用本发明中药制剂，口服，每日2次，早晚各1次，每次2粒（每粒0.5g)，饭后温开水送服；15天为1个疗程，2～4个疗程即可痊愈，病情严重者遵医嘱酌增用量。
对照组服用银杏叶分散片，口服，一次2粒，一日3次，饭后服用，病情严重者遵医嘱酌增用量。
3、疗效判定：
（1）治愈：冠心病、心绞痛、心力衰竭等症状全部消失，心率恢复正常。
（2）显效：上述症状明显减轻，心率有所好转。
（3）有效：上述症状有所减轻，心率明显好转。
（4）无效：通过治疗后上述症状无变化或加重。
4、结果：
以上结果显示，治疗组的治愈率和总有效率明显高于对照组。
典型病例举例：
1、傅某，女，50岁，广东惠州人。患者患冠心病3年，心脏肥厚增大、心力衰竭、阵发性心动过速时有发现，诊断为缺血性冠心病，服用本发明中药制剂治疗，服用1个疗程后，症状出现的次数大大减少，继续服用2个疗程后，症状消失，检查恢复正常，随访至今未复发。
2、程某，男，43岁，湖南衡阳人。患者诊断出患冠心病，使用过多种药物治疗，未见任何好转，经人介绍来我院就诊，给予本发明中药制剂治疗，服用本发明中药制剂1个疗程后，症状有所减轻，继续服用2个疗程后，痊愈，1年后随访无复发。
3、阎某，女，61岁，甘肃酒泉人。患者突发心梗，前去医院就诊，立即给予本发明中药制剂治疗，服用1次后，冠心病症状有所见效，继续服用本发明中药制剂3个疗程后，经复查，心梗症状完全消除，1年后随访无复发。
4、卢某，男，68岁，江西鹰潭人。患者患冠心病，多次去大医院诊治，未见有明显疗效，前来我院就诊，给予本发明中药制剂治疗，服用1个疗程后，冠心病明显好转，继续服用2个疗程后，症状消除，2年后随访无复发。
5、杜某，女，55岁，北京怀柔区人。患者在一次活动中出现心悸、气急、烦躁、心绞痛症状，伴有发热、心动过速、白细胞增高等症状，严重时出现心力衰竭，诊断为心肌梗死型冠心病，多处治疗未彻底治愈，经人介绍采用本发明中药制剂治疗，服用1个疗程后，发病次数大大减少，继续服用2个疗程后，症状消失，检查恢复正常，随访至今未复发。
6、姜某，男，72岁，重庆江北区人。患者诊断出患冠心病，多方求医，花钱无数，均无明显疗效，前来我院就诊，给予本发明中药制剂治疗，服用1个疗程后，症状有所减轻，继续服用2个疗程后，症状完全消除，1年后随访无复发。
Claims (5)
1.一种治疗冠心病的中药制剂，其特征在于：制成所述中药制剂有效成分的原料组成及重量份数为：
柏子仁62～86份槐花61～85份荜拔61～85份白芍药57～81份
莲子56～80份龙骨55～79份刘寄奴55～79份苦菜51～75份
鸡血藤47～71份海木42～66份狐心39～63份合欢皮37～61份
相思藤37～61份银耳36～60份丹参32～56份郁金17～41份。
2.根据权利要求1所述的一种治疗冠心病的中药制剂，其特征在于：制成所述中药制剂有效成分的原料组成及重量份数为：
柏子仁66～82份槐花65～81份荜拔65～81份白芍药61～77份
莲子60～76份龙骨59～75份刘寄奴59～75份苦菜55～71份
鸡血藤51～67份海木46～62份狐心43～59份合欢皮41～57份
相思藤41～57份银耳40～56份丹参36～52份郁金21～37份。
3.根据权利要求1所述的一种治疗冠心病的中药制剂，其特征在于：制成所述中药制剂有效成分的原料组成及重量份数为：
柏子仁70～78份槐花69～77份荜拔69～77份白芍药65～73份
莲子64～72份龙骨63～71份刘寄奴63～71份苦菜59～67份
鸡血藤55～63份海木50～58份狐心47～55份合欢皮45～53份
相思藤45～53份银耳44～52份丹参40～48份郁金25～33份。
4.根据权利要求1所述的一种治疗冠心病的中药制剂，其特征在于：制成所述中药制剂有效成分的原料组成及重量份数为：
柏子仁74份槐花73份荜拔73份白芍药69份
莲子68份龙骨67份刘寄奴67份苦菜63份
鸡血藤59份海木54份狐心51份合欢皮49份
相思藤49份银耳48份丹参44份郁金29份。
5.一种如权利要求1～4任一项所述治疗冠心病的中药制剂的制备方法，其特征在于：包括以下工艺步骤：
（1）将柏子仁、荜拔、白芍药、莲子、龙骨、刘寄奴、合欢皮、相思藤、银耳、丹参和郁金洗净，放入容器内，加入8～10倍量的蒸馏水，浸泡5～6小时后，煮沸3～4小时，提取；再次加入6～8倍量蒸馏水，煮沸2～3小时，提取；最后，加入4～6倍量蒸馏水，加热煮沸1～2小时，提取；合并三次提取液，过滤，得滤液，浓缩成60℃下相对密度为1.10～1.13的稠膏，备用；
（2）将槐花放入锅内，武火炒制至微黄，取出凉透，研末，过160目筛得细粉，备用；
（3）将苦菜洗净，切碎，放入容器内，绞汁，滤杂质，留汁液备用；
（4）将鸡血藤和海木洗净，浸入5倍量的80%的乙醇溶液浸泡1～2小时，加热提取3小时，回收乙醇，滤过，得滤液，浓缩为65℃下相对密度为1.12～1.16的稠膏，备用；
（5）将狐心烘干放入容器内，进行粉碎处理，研末，过180目筛得细粉，备用；
（6）将上述步骤（1）～（5）所制得的稠膏、细粉以及汁液混合，制成胶囊，即得所述的治疗冠心病的中药制剂。
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