CN114848744B - 一种治疗气虚血瘀型冠心病的中药组合物及其制备方法 - Google Patents
一种治疗气虚血瘀型冠心病的中药组合物及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗气虚血瘀型冠心病的中药组合物及其制备方法。所述中药组合物包括以下重量份的组分：黄芪15‑30份、丹参12‑24份、赤芍12‑24份、檀香3‑6份、浙贝12‑24份、玄参9‑18份、水蛭3‑6份、三七粉3‑6份。本申请中药针对气虚血瘀型冠心病病因病机，各味药材各具其效，互相为用，方中黄芪益气健脾、生津养血，丹参、赤芍活血祛瘀、清热凉血，檀香行气温中、开胃止痛，浙贝、玄参清热养阴、软坚散结，水蛭、三七粉破血逐瘀、通络止痛，诸药相和，共凑益气养血、活血软坚之功。
Description
技术领域
本发明涉及中药组合物领域，特别涉及一种治疗气虚血瘀型冠心病的中药组合物及其制备方法。
背景技术
世界卫生组织指出，心血管疾病是全球主要的死亡原因，2019年估计有1790万人因心血管疾病而丧生，约占世界所有死亡人数的32％。根据《中国心血管健康与疾病报告2020》，我国心血管病患病率及病死率仍处于上升阶段，推算共计3.3亿心血管病患者。其中冠心病患者1139万。在我国，其发病率逐年增加并有年轻化的趋势，统计显示我国每年新发病率为0.77％，动脉粥样硬化是导致冠状动脉粥样硬化性心脏病的首要病因，占致病因素的99％。动脉粥样硬化呈慢性炎症性进展过程，是冠心病发生发展的主要病理基础，其病因是大动脉和中型动脉上聚集大量胆固醇和脂质最终演变为纤维斑块，发病机制主要涉及炎症反应、损伤应答反应等方面，有研究显示，动脉粥样硬化与气虚血瘀型胸痹具有相关性。潜在的发病机制涉及脂质代谢失衡和激活的免疫反应，导致动脉壁的慢性炎症。持续的炎症刺激和血管内脂类增加容易导致血管壁增厚，致使动脉管壁的弹性减退和斑块不稳定性增加，加大了动脉管腔狭窄及血栓栓塞的风险，从而引起一系列临床心脑血管疾病和不良临床事件的发生。
随着研究的深入，对冠心病的病理生理学的理解发生了显著的变化，从动脉重塑(代偿性扩大)的关注到将注意力从血管造影术所见的狭窄，扩展到了涵盖非狭窄性斑块的生物学领域，虽然血运重建可有效缓解局部缺血，但研究现在也认识到需要治疗非阻塞性病变。可能不会产生严重狭窄的不稳定性斑块破裂却会导致许多ACS的发生。冠心病(CAD)的治疗应包括机械血运重建和全身性预防干预的方法。所以“稳定”其它可能会破裂的斑块是治疗冠心病的潜在重要目标之一，这对治疗冠心病显得意义非凡，大约99％冠心病的病因是动脉粥样硬化。因此，对动脉粥样硬化，特别是动脉斑块的研究，是治疗的关键。加强对抗动脉粥样硬化的临床药物研究，对冠心病的防治具有极大的社会和经济效益。
冠心病心绞痛对应的中医概念为胸痹心痛，其发生多与年老体虚、饮食不当、寒邪内侵、情志失调等因素有关。最早见于《金匮要略·胸痹心痛短气病脉证治》篇，其原文高度概括胸痹心痛的病因病机为“阳微阴弦”，“阳微”即正虚为本，指心气不足、心血亏虚、心阴亏损和心阳不振，“阴弦”即阴邪干犯为标，标实有因于气滞、寒凝、血瘀、痰浊之不同，所以病机关键是本虚标实。冠心病之发病，不通则痛、不荣则通是其中主要环节，造成心脉痹阻的原因有“气塞不通，血壅不流”，亦有“元气既虚，必不能达于血管，血管无气，必停流而瘀”(《医林改错·论抽风不是风》)，“瘀为百病之始，心脉瘀阻，心失其所养，不能主血脉，不通则痛，故为心痹”，研究发现，在冠心病心绞痛中，气虚本证占71.6﹪，血瘀标证占70.3﹪，表明气虚血瘀是冠心病心绞痛最基本的病理基础，因此针对冠心病气虚血瘀证治则治法的选择是关键且具有较大的实用意义。
常规西药虽药理机制明确，临床疗效肯定，但往往只能针对某一方面的临床症状或改善某一类理化指标，在治疗冠心病方面往往存在着肝肾功能损害、出血风险增加等一系列并发症，且不少患者对长期服用西药往往存在畏惧心理，难以长期坚持，而中药因其具有多途径、多靶点的干预效应，对综合改善患者临床症状，增强西药疗效，减轻西药不良反应等方面具有独特优势，可以和西医规范药物治疗互相补充，相得益彰。所以，申请人认为，提供一种治疗气虚血瘀型冠心病的中药配方具有重要意义。
发明内容
本发明为了解决上述技术问题，提供了一种治疗气虚血瘀型冠心病的中药组合物及其制备方法，其临床疗效明确，改善冠心病症状明显，且能延缓或逆转动脉粥样硬化斑块进展，质量相对可控，功效在益气养血、活血软坚，产生协同作用，疗效显著。
本发明是采用以下技术方案得以实现的。
一种治疗气虚血瘀型冠心病的中药组合物，包括以下重量份的组分：黄芪15-30份、丹参12-24份、赤芍12-24份、檀香3-6份、浙贝12-24份、玄参9-18份、水蛭3-6份、三七粉3-6份。
鉴于冠心病中医临床证型复杂，本发明针对其主要证型气虚血瘀证并根据临床实践相应拟方而成。临床案例证实其不仅能有效缓解胸闷、胸痛、气短乏力、心悸心慌等临床症状，而且能改善实验室指标及影像检查，特别是在延缓或逆转动脉粥样硬化斑块方面有独特之处。本申请中药组合物由黄芪、丹参、赤芍、檀香、浙贝、玄参、水蛭、三七粉等8味中药组成，方中黄芪益气健脾、生津养血，丹参、赤芍活血祛瘀、清热凉血，檀香行气温中、开胃止痛，浙贝、玄参清热养阴、软坚散结，水蛭、三七粉破血逐瘀、通络止痛。诸药相和，共凑益气养血、活血软坚之功。该方攻补兼施，行而不滞，攻而不伤，注重固护后天脾胃之本，无攻伐伤正之虞。现代药理研究表明，黄芪具有降低血液黏稠度、抑制血小板聚集、抗动脉粥样硬化的作用；丹参中的有效化合物丹参酮ⅡA具有抗凝血、抗动脉粥样硬化、调节血脂等作用；赤芍的主要化合物具有扩张冠状动脉、增加冠状动脉血流量，抑制血小板聚集等作用；檀香作用机理可能与抗氧化和扩张冠状动脉血管有关；三七具有抗炎、促进造血、止血、抗血栓、抗心律失常等功能；水蛭具有抗凝血、抗血栓、抗肿瘤、抗动脉粥样硬化、抗纤维化等多种生物活性等作用。
进一步的，一种治疗气虚血瘀型冠心病的中药组合物，包括以下重量份的组分：黄芪30份、丹参12份、赤芍12份、檀香3份、浙贝12份、玄参9份、水蛭3份、三七粉3份。
一种上述治疗气虚血瘀型冠心病的中药组合物的制备方法，包括以下步骤：
S1.称取规定量的水蛭、三七粉、地龙，进行粉碎；
S2.称取规定量的黄芪、丹参、赤芍、浙贝、玄参，将上述原料药按照重量比为14-28:55-110分成两部分；
S3.将步骤S2中重量份数较小的部分原料药进行粉碎；
S4.将步骤S2中重量份数较大的部分原料药进行煎煮；
S5.将步骤S1和步骤S3得到的药粉与步骤S4得到的药液进行混合，制成丸剂。
通过采用上述技术方案，本方中虫类药物打粉，提升疗效；糊丸如绿豆大小，方便服用。丸者缓也，药效持久，丸剂对慢性疾病可长期服用，且易于保存携带。本丸中有理气健脾、固护脾胃之药，减少长期服用对胃肠道的影响。
本申请具有以下有益效果：
本申请的中药组合物可以改善气虚血瘀型冠心病患者气短乏力、心慌胸闷、胃纳不佳等临床症状，增加活动耐量，提高冠心病患者的生活质量；可以改善气虚血瘀型冠心病患者血脂、血糖等实验室指标异常，降低危险因素风险，可做为二级预防药物长期服用，改善患者远期临床预后；可以改善气虚血瘀型冠心病患者斑块大小及动脉粥样硬化程度，改善冠脉微循环。本申请在冠心病的防治过程中运用中药复方制剂，具有较好的临床疗效且能充分改善患者的临床预后，有较为广阔的应用前景。
具体实施方式
以下结合实施例对本专利申请进行进一步的说明。
实施例
一种治疗气虚血瘀型冠心病的中药组合物的制备方法，包括以下步骤：
S1.称取水蛭42g、三七粉42g、檀香42g，共计126g，进行粉碎，粉碎后的粒径为0.2mm；
S2.称取黄芪420g、丹参168g、赤芍168g、浙贝168g、玄参126g，共计1050g，将上述原料药按照重量比为2:8分成两部分；
S3.将步骤S2中重量份数较小的部分原料药进行粉碎，粉碎后的粒径为0.2mm；
S4.将步骤S2中重量份数较大的部分原料药进行煎煮，先将药材用冷水浸泡1小时，浸泡的水量以淹没药面2cm为宜，将药放在火上，用武火(100℃)熬开，沸腾后改用文火(100℃)保持微沸状态，第一次煎煮30分钟，将药液倒出，第二次煎煮加入淹没药渣2cm的热水，煎煮30分钟，将药液倒出，将2次药液混合得1剂(200ml)；
S5.将步骤S1和步骤S3得到的药粉与步骤S4得到的药液进行混合，制成如绿豆大小丸剂。14剂，浓缩丸，6g/次，2次/日，28天为1疗程。
临床实验
临床试验参与研究中心：杭州市中医院
试验开展时间：2020.07--2021.10.31
患者来源：入选2020.07至2021.10.31因冠状动脉狭窄及冠脉PCI术后于杭州市中医院心血管病科门诊就诊及住院患者
1、纳入标准：
①符合以下中西医诊断标准；
②年龄：18-85岁；
③冠脉Gensini评分：5-30分；
④自愿参加本研究并签署知情同意书的患者。
西医诊断标准：根据冠脉造影示主要冠脉(左主干、前降支、回旋支、右冠脉)血管轻中度狭窄(狭窄程度26％-75％)的患者；PCI术后(含支架和药物球囊)的患者。
中医诊断标准：参考《中医病证诊断疗效标准》气虚血瘀的标准：主症：胸痛、胸闷。次症：心悸气短，神倦乏力，面色紫暗。舌脉：脉弦/细/弱/涩，舌质淡紫苔薄白，舌下络脉青紫。
2、排除标准：
①不稳定性心脏绞痛或急性心肌梗死的患者；
②冠状动脉介入性高血压的患者；
③妊娠或哺乳期妇女；
④精神类疾病的患者；
⑤合并有高血压病三级极高危的患者；
⑥冠状动脉炎，梅毒性主动脉炎，肥厚型心肌病，先天性冠状动脉畸形引起心脏绞痛的患者；
⑦合并严重肾功能不全，呼吸衰竭，肝功能衰竭及甲状腺功能亢进的患者。
⑧依从性差，不能坚持服用通冠益心丸、不能接受西医规范化治疗、不能配合检查的患者；
⑨舌苔厚腻或在入组期间服用其它中药及成药的患者。
本申请药物(以下称为通冠益心方)进行了冠脉狭窄组和冠脉PCI术后组的预实验，共纳入了26例临床病例，其中冠脉狭窄组16例，PCI术后10例，相关结果如下：
冠脉狭窄组：2020.07开始前期准备，随机数字表法入组冠脉狭窄组病例16例，通冠益心方组(通冠益心方组是在常规西药治疗的基础上联用中药通冠益心方治疗)与对照组(对照组根据患者合并症，采用单纯西药治疗；一般需要予抗血小板聚集、降脂、降压等药物)各8例，规范治疗并随访，截止2021.10.31，脱落5例，其中通冠益心方组2例，对照组3例，具体观察指标如下。
冠脉狭窄病例初始资料分析
以上可知，通冠益心方组与对照组各积分项P值均＞0.05，说明初入组时两组基线水平相同，差异无统计学意义，具有可比性。
冠脉狭窄病例治疗半年资料分析
以上可知，通冠益心方组与对照组各积分项P值均＞0.05，经通冠益心方治疗半年后，和单纯西药组相比，疗效未出现统计学差异。
冠脉狭窄病例治疗1年资料分析
注：*P＜0.05
经过1年的治疗后，通冠益心方组冠脉Gensini评分、颈动脉斑块等级积分、舌下络脉等级评分均较单纯西药组下降，HDL-C水平较单纯西药组升高，两组对比，P＜0.05，差异具有统计学意义，说明较单纯西药治疗组，通冠益心方组联合西药组治疗疗效更显著。
冠脉PCI术后组：2020.07开始前期准备，随机数字表法入组冠脉PCI术后病例10例，通冠益心方组(通冠益心方组是在常规西药治疗的基础上联用中药通冠益心方治疗)与对照组(对照组根据患者合并症，采用单纯西药治疗；一般需要予抗血小板聚集、降脂、降压等药物)各5例，规范治疗并随访，截止2021.10.31，无脱落病例，具体观察指标如下。
冠脉PCI术后病例初始资料分析
以上可知，通冠益心方组与对照组各积分项P值均＞0.05，说明初入组时两组基线水平相同，差异无统计学意义，具有可比性。
冠脉PCI术后病例治疗半年资料分析
以上可知，通冠益心方组与对照组各积分项P值均＞0.05，经通冠益心方治疗半年后，和单纯西药组相比，疗效未出现统计学差异。
冠脉PCI术后病例治疗1年资料分析
注：*P＜0.05
经过1年的治疗后，通冠益心方组冠脉Gensini评分、颈动脉斑块半定量积分、舌下络脉等级评分均较单纯西药组下降，HDL-C水平较单纯西药组升高，两组对比，P＜0.05，差异具有统计学意义，说明较单纯西药治疗组，通冠益心方组联合西药组治疗疗效更明显。
26例临床病例中的典型案例：
潘某某，男，61岁，反复活动后胸闷4月余，曾2次行冠脉造影+PCI术，术后规范服用降压降脂，抗血小板聚集等药物，但仍时有心前区隐痛不适，心悸胸闷，活动耐量减低，胃纳不佳，夜寐一般，脉弦细，舌质红苔薄黄，舌下络脉青紫。主要诊断为“冠状动脉支架植入后状态、高血压、高脂血症”。嘱患者继续坚持规范西药治疗，加用通冠益心方丸剂口服，服用3个疗程后，患者病情稳定，心慌胸闷等症状基本已无明显再发作，活动耐量增加，一般情况可。
裘某某，女，78岁，冠心病支架植入术后、高血压、高脂血症、动脉硬化、梗阻性肥厚型心肌病复诊。规范口服冠心病二级预防药物，平素活动后胸闷，拍打后好转，时有乏力感，背部拘急，血压常有波动，胃口较差，夜尿频。脉弦，舌质红苔少薄黄，舌下络脉青紫。在西药基础上加用通冠益心方丸剂口服4个疗程后，心悸胸闷明显减轻，活动量增加，乏力较前明显改善，血压控制尚稳定，纳寐可。
张某某，女，71岁，高血压病、脑梗死后遗症、冠状动脉粥样硬化复诊。现服用抗血小板聚集，调脂稳斑，降压等药物。时有心慌胸闷不适，活动后头晕，后颈部不适，胃脘疼痛。脉弦缓，舌质紫红苔薄，舌下络脉青紫红。经加用通冠益心方丸剂口服3个疗程后，患者无明显头晕，颈部不适好转，心悸胸闷未明显发作，病情稳定。
王某某，男，76岁，冠心病、房颤射频消融术后、高血压、糖尿病复诊。现予降压降脂、抗血小板聚集、调脂稳斑、改善心肌代谢等药物治疗，活动胸闷气急明显，时有心悸胸痛发作，夜梦多，精神一般。脉弦细，舌质紫红苔薄白，有裂纹，舌下络脉紫红。加用通冠益心方丸剂口服5个疗程后，患者活动耐量明显增加，心悸胸痛基本已无再发，活动后无明显胸闷气急，夜寐好转，精神状态可。
本具体实施方式的实施例均为本发明的较佳实施例，并非依此限制本发明的保护范围，故：凡依本发明的结构、形状、原理所做的等效变化，均应涵盖于本发明的保护范围之内。
Claims (3)
1.一种治疗气虚血瘀型冠心病的中药组合物，其特征在于：由以下重量份的组分组成：黄芪15-30份、丹参12-24份、赤芍12-24份、檀香3-6份、浙贝12-24份、玄参9-18份、水蛭3-6份、三七粉3-6份。
2.根据权利要求1所述的一种治疗气虚血瘀型冠心病的中药组合物，其特征在于：由以下重量份的组分组成：黄芪30份、丹参12份、赤芍12份、檀香3份、浙贝12份、玄参9份、水蛭3份、三七粉3份。
3.一种权利要求1或2所述治疗气虚血瘀型冠心病的中药组合物的制备方法，其特征在于：包括以下步骤：
S1.称取规定量的水蛭、三七粉、檀香，进行粉碎；
S2.称取规定量的黄芪、丹参、赤芍、浙贝、玄参，将上述原料药按照重量比为14-28:55-110分成两部分；
S3.将步骤S2中重量份数较小的部分原料药进行粉碎；
S4.将步骤S2中重量份数较大的部分原料药进行煎煮；
S5.将步骤S1和步骤S3得到的药粉与步骤S4得到的药液进行混合，制成直径2mm丸剂。
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