CN107184760A - 用于治疗心血管疾病的中药组合物及其制备方法 - Google Patents
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Abstract
本发明涉及一种用于治疗心血管疾病的中药组合物及其制备方法，属于中药领域。所述中药组合物，其由10‑40重量份的白参、20‑50重量份的黄芪、10‑40重量份的川芎、15‑45重量份的丹参、10‑40重量份的三七、1‑20重量份的血竭和10‑40重量份的当归制成。
Description
技术领域
本发明涉及一种用于治疗心血管疾病的中药组合物及其制备方法，属于中药领域。
背景技术
随着人们生活水平的提高，心血管疾病已成为危害人类健康的主要疾病，近年来的流行病学调查显示，我国人群心血管疾病发病率和死亡率均呈持续上升趋势，且发病年龄逐渐降低，已经成为一种严重威胁人类健康，影响人们生活质量的常见病、多发病，尤其是急性心肌缺血严重危害人类的身体健康。
心肌缺血是指心脏的血液灌注减少，导致心脏的供氧减少，心肌能量代谢不正常，不能支持心脏正常工作的一种病理状态；即心脏某一部位血供严重或完全不足，致使该部位心肌氧和营养物质供应不足或中断，代谢产物堆积所造成的病理状态，严重时可导致心肌坏死，多由冠脉痉挛、冠脉严重或完全阻塞造成。
冠状动脉粥样硬化导致的冠脉狭窄或闭塞是引起心肌缺血最主要、最常见的病因，进而导致心肌缺血缺氧，由此引起的心脏病即大家常说的“冠心病”，所以冠状动脉粥样硬化是导致冠心病心肌缺血的“罪魁祸首”。
心肌缺血严重危害中老年人的健康，近年来随着生活水平的提高，冠状动脉粥样硬化呈现年轻化的趋势，一些20-30岁的年轻人也出现心肌缺血的表现。心肌缺血临床可表现为心绞痛、心肌梗塞、心律失常及心力衰竭。
由于心肌缺血有发生心肌梗死和猝死的危险，因此发现心肌缺血时，要及早治疗。积极预防动脉粥样硬化的发生，如已发生，应积极治疗，防止病变发展并争取逆转。已发生并发症者，应及时治疗，防治恶化，延长患者寿命。现代医学对本病治疗主要有药物治疗、外科手术、介入、干细胞移植及基因治疗。
目前对冠心病的药物治疗主要分为硝酸酯类、β受体阻滞剂、钙离子通道阻滞剂、抗凝药和抗血小板聚集类、他汀类和血管转换酶抑制剂(简称：ACEI)等。但这些药物也都存在着较为明显的副作用。长期大量给药时会出现药物依赖性和各种不良反应。
而以中药治疗冠心病的治疗药物中，以其不良反应少、副作用小的优势也占据较大的市场份额。例如：由人参、党参、当归、丹参、红花组成的益气活血方[祝维峰，山东中医学院学报，1994，18(5)]；由生脉饮加丹参、人参、三七、红花、元胡、山楂组成的丹芪生脉饮，[陈宇春，光明中医，1999，14(5)]；由人参、党参、麦冬、丹参、川芎、降香组成的冠心病基本方[王金荣等，辽宁中医杂志，2001，28(8)]；由丹参、延胡索、人参、三七、川芎、当归组成的舒心通脉片[王秀娥等，山东中医杂志，1997，16(8)]；等等。但以上临床处方和中成药均有一定的不足之处，或偏于益气，或偏于通阳，或偏于活血，临床上未得到全面推广。
发明内容
本发明的第一方面是提供一种用于治疗心血管疾病的中药组合物，其由白参、黄芪、川芎、丹参、三七、血竭和当归制成。
在一个实施方案中，所述中药组合物，其由10-40重量份的白参、20-50重量份的黄芪、10-40重量份的川芎、15-45重量份的丹参、10-40重量份的三七、1-20重量份的血竭和10-40重量份的当归制成。
在另一个实施方案中，所述中药组合物，其由10-20重量份的白参、20-40重量份的黄芪、10-20重量份的川芎、20-30重量份的丹参、10-30重量份的三七、5-15重量份的血竭和10-20重量份的当归制成。
在进一步地实施方案中，所述中药组合物，其由15重量份的白参、30重量份的黄芪、15重量份的川芎、25重量份的丹参、20重量份的三七、10重量份的血竭和15重量份的当归制成。
本发明的第二方面是提供所述中药组合物的制备方法，具体步骤如下：
(1)取黄芪药材粉碎，以10-14倍量的水回流提取三次，每次提取时间2h，过滤合并滤液，减压浓缩获得浸膏1；
(2)取白参、川芎、丹参、三七、血竭和当归药材，粉碎混匀，以6-10倍量的70％乙醇回流提取三次，每次提取时间2h，过滤合并滤液，减压浓缩获得浸膏2；
(3)将浸膏1和浸膏2合并即得所述中药组合物。
在一个实施方案中，所述中药组合物的制备方法，具体步骤如下：
(1)取黄芪药材粉碎，以12倍量的水回流提取三次，每次提取时间2h，过滤合并滤液，减压浓缩获得浸膏1；
(2)取白参、川芎、丹参、三七、血竭和当归药材，粉碎混匀，以8倍量的70％乙醇回流提取三次，每次提取时间2h，过滤合并滤液，减压浓缩获得浸膏2；
(3)将浸膏1和浸膏2合并即得所述中药组合物。
本发明的第三方面是提供一种包含所述中药组合物的药物制剂，其由所述中药组合物和药学上可接受的辅料组成。
在一个实施方案中，所述药物制剂为口服制剂，所述口服制剂可以是片剂、包衣片剂、散剂、颗粒剂、胶囊、口服液、丸剂、悬浮剂、乳剂等。
在另一个实施方案中，所述辅料选自淀粉、β-环糊精、糊精、卡波姆、微晶纤维素、羟丙基甲基纤维素、低取代羟丙基纤维素、羧甲基纤维素钙、聚乙二醇(PEG)、羧甲基纤维素钠、甲基纤维素、乙基纤维素、甘露醇、十二烷基硫酸钠、交联羧甲基纤维素钠、乳糖、聚乙烯吡咯烷酮(PVP)、交联聚乙烯吡咯烷酮、聚氧乙烯蓖麻油酸甘油酯、硬脂酸镁、滑石粉、微粉硅胶、阿斯巴甜、甜橙香精、碳酸氢钠、碳酸钠、肠溶包衣粉中的一种或几种。
在进一步地实施方案中，所述口服制剂为颗粒剂，所述辅料由淀粉、糊精和聚氧乙烯蓖麻油酸甘油酯。具体地说，所述糊精、淀粉和聚氧乙烯蓖麻油酸甘油酯的重量比为1-5∶0.5-2∶0.2，优选为3∶1∶0.2。
在又一个实施方案中，在药物制剂中，所述中药组合物和辅料的重量比为1∶1-3，进一步地优选为1∶2。
本发明的第四方面是提供所述中药组合物在制备治疗心血管疾病药物中的应用。
在本发明中药组合物中，白参，甘温益气，能大补元气，为君药。黄芪甘温，能益气固表，与人参相伍，一者偏于补中气，一者偏于固护表气，君臣相配，可补一身内外之气。三七为臣，三七苦甘温，善于化瘀止血，与人参相伍，可收益气活血之功。当归为血中气药，能走能守，善能补血和血；川芎行气活血，使之补而不滞；丹参善入心经，活血化瘀止痛有祛瘀生新之功；血竭散瘀定痛，共助三七活血化瘀止痛之效，且活血而不伤血，均为佐药。诸药合用，全方共奏益气养血，活血止痛之效。
具体实施方式
还可进一步通过实施例来理解本发明，其中所述实施例说明了一些制备或使用方法。然而，要理解的是，这些实施例不限制本发明。现在已知的或进一步开发的本发明的变化被认为落入本文中描述的和以下要求保护的本发明范围之内。
实施例1中药组合物的制备
药材检验合格后，净选，将30kg黄芪，加入12倍量水，浸泡0.5h，回流提取3次，每次2h，合并滤液。然后将15kg白参、15kg川芎、25kg丹参、20kg三七、10kg血竭、15kg当归加入8倍量70％乙醇，回流提取3次，每次2h，合并滤液。把水提取与醇提取的滤液合并，静置12h，抽滤，滤液减压回收乙醇，并减压浓缩成稠膏状。后用粉碎机粉碎，粉末过14目筛即得。
实施例2中药组合物对大鼠心肌缺血模型的影响
模型制备：取雄性SD大鼠，体重250±50g，每组10只。在末次给药后30分钟，1％戊巴比妥钠腹腔注射麻醉，将大鼠仰位固定；将心电图电极针埋在左下肢及右上肢皮下，于左侧剪断第四肋，用血管钳沿第四肋钝性分离肋间肌3cm长，打开胸腔，撑开肋骨，将心脏挤出胸腔。在左心耳下方2mm处用眼科针6-0丝线穿线，进针深度约1-1.5mm，宽约2-3mm，连同心大静脉一起结扎冠状动脉左前降支(假手术组只穿线不结扎)。结扎后把心脏迅速放回胸腔。心电图显示ST段显著抬高或异常Q波时；即表明急性心肌缺血造模成功。迅速缝合胸壁，停止人工呼吸，清除呼吸道分泌物，缝合关闭气管，24h后处死。结扎10min心电图ST段没有变化者淘汰。
给药方案：假手术组：灌服等量的水溶液；模型组：灌服等量的水溶液；各组动物均按体重灌胃给予受试药物(5ml/kg)。每天1次，共给药3次。
检测指标：
(1)心肌缺血梗死面积百分比的测定：术后24h处死大鼠，取心脏，在结扎线以下将左心室切成厚度为2mm的4-5片，放入1％TTC溶液中，在37℃水浴、避光条件下染色10min，梗死区不着色(白色)，非梗死区染成红色，1％多聚甲醛固定4h，用Image-J(NIH)软件计算梗死区面积百分比。心肌梗死面积百分比(S)％＝梗死区面积/左心室总面积×100％。
(2)左室血流动力学指标测定：术后24h，再次将大鼠腹腔注射1％戊巴比妥钠麻醉，然后静脉推注肝素全身抗凝，手术分离右颈总动脉后应用生理记录仪检测心脏血流动力学参数。插管至左心室记录压力曲线，记录左室最大收缩(+)和舒张(-)速率(±dp/dtmax)。
(3)处死大鼠之前，腹主动脉取血，1000rpm离心取血清，采用ELISA试剂盒测定血清中LDH和CK-MB含量。
结果如下：
(1)心肌缺血梗死面积：
＊或＊＊为药物组与模型组相比，T检验P＜0.05或0.01。
对比例1的中药组方为35kg白参、15kg黄芪、10kg川芎、35kg丹参、15kg三七、15kg血竭和15kg当归；制备方法同实施例1
对比例2的中药组方为10kg白参、30kg黄芪、20kg川芎、15kg丹参、30kg三七、15kg血竭和10kg当归；制备方法同实施例1
对比例3的中药组方为20kg白参、20kg黄芪、20kg川芎、20kg丹参、15kg三七、15kg血竭和15kg当归；制备方法同实施例1
(2)左室血流动力学指标：
＊或＊＊为药物组与模型组相比，T检验P＜0.05或0.01。
(3)血清中LDH和CK-MB含量
＊或＊＊为药物组与模型组相比，T检验P＜0.05或0.01。
实施例3中药组合物对缺氧缺糖心肌细胞的影响
取人H9C2心肌细胞进行传代培养，然后收集细胞，将细胞以1×106个/ml的密度接种于24孔板中，每孔500μl。37℃、5％CO2饱和湿度条件下培养。心肌细胞培养24h后，正常对照组和模型组以500μl DMEM培养液正常培养(含10％FBS)，各给药组加入含药液的DMEM培养液(含10％FBS)，孵育6h后，用冰冷PBS冲洗2遍，模型组及给药组每孔加入500μl经95％N2-5％O2饱和的Tyrode液，然后将培养板放入一密闭容器内，持续通以混合气体(95％N2-5％O2)30min后密闭容器，放入孵箱缺氧12h，模拟在体缺血模型。正常组洗净旧培养基后加入含10g/L葡萄糖的Tyrode液500μl，CO2培养箱中培养12h。
每孔加入终浓度为0.5mg/ml MTT 500μl培养4h，然后倾去上清液，加入500μl的DMSO，振摇10min，用全自动酶标仪测定570nm处的吸光度值(OD570nm)，用于定量细胞存活率。
将处理后的培养板每孔吸取200μl培养上清液，根据LDH检测试剂盒说明，检测LDH活性。
具体结果如下：
细胞存活率(MTT)及LDH活性：
| 分组 | 剂量(终浓度) | LDH(U/L) | 细胞活性(％) |
| 假手术组 | - | 13.6±2.7 | 100 |
| 模型组 | - | 127.4±5.9## | 53.2±2.9## |
| 实施例1 | 100mg/L | 54.8±4.3＊＊ | 88.6±3.4＊＊ |
| 对比例1 | 100mg/L | 99.7±5.7＊ | 61.4±3.1＊ |
| 对比例2 | 100mg/L | 83.4.±4.8＊＊ | 65.2±3.3＊ |
| 对比例3 | 100mg/L | 108.9±4.7＊ | 58.9±3.4 |
＊或＊＊为药物组与模型组相比，T检验P＜0.05或0.01；##为模型组与假手术组相比，T检验P＜0.01。
对比例的制备方法同实施例2.
实施例4中药颗粒剂的制备
取实施例1制备的中药组合物100g，加入142.9g糊精、47.2g淀粉和9.9g聚氧乙烯蓖麻油酸甘油酯，并混合均匀，加入0.24ml/g的70％乙醇，制成软材，根据经验“手握成团，轻压即散”为原则掌握软材的质量，过14目筛制粒，湿颗粒于60℃干燥，干颗粒过14目筛整粒，再过4号筛(65目)筛去细粉，然后分装，密封，包装即得。
实施例5中药颗粒剂的稳定性试验
按照中国药典2010版二部附录的稳定性指导原则考察相关样本稳定性，分别考察了在、25℃及相对湿度75％条件下放置90天的药物稳定性。采用HPLC法测定颗粒剂中人参皂苷Rg1、黄芪甲苷和丹参酮IIA的含量。
25℃及相对湿度75％条件下放置90天后各组中药有效成分含量(n＝10)
对比例1的颗粒剂组方为：100g实施例1中药组合物、133.3g糊精和66.7g淀粉；制备方法同实施例4；
对比例2的颗粒剂组方为：100g实施例1中药组合物、142.9g糊精、47.2g淀粉和9.9gPEG-400；制备方法同实施例4；
对比例3的颗粒剂组方为：100g实施例1中药组合物、142.9g糊精、47.2g淀粉和9.9g吐温-20；制备方法同实施例4。
实施例6
采用固定漏斗法(奚念朱主编《药剂学》第三版)测定样本灌装前颗粒的休止角。
结果如下：
| 休止角 | |
| 实施例1 | 23° |
| 对比例1 | 28° |
| 对比例2 | 31° |
| 对比例3 | 26° |
本发明内容仅仅举例说明了要求保护的一些具体实施方案，其中一个或更多个技术方案中所记载的技术特征可以与任意的一个或多个技术方案相组合，这些经组合而得到的技术方案也在本申请保护范围内，就像这些经组合而得到的技术方案已经在本发明公开内容中具体记载一样。
Claims (10)
1.一种用于治疗心血管疾病的中药组合物，其由白参、黄芪、川芎、丹参、三七、血竭和当归制成。
2.根据权利要求1所述的中药组合物，其特征在于，所述中药组合物，其由10-40重量份的白参、20-50重量份的黄芪、10-40重量份的川芎、15-45重量份的丹参、10-40重量份的三七、1-20重量份的血竭和10-40重量份的当归制成。
3.根据权利要求2所述的中药组合物，其特征在于，所述中药组合物，其由10-20重量份的白参、20-40重量份的黄芪、10-20重量份的川芎、20-30重量份的丹参、10-30重量份的三七、5-15重量份的血竭和10-20重量份的当归制成。
4.根据权利要求2所述的中药组合物，其特征在于，所述中药组合物，其由15重量份的白参、30重量份的黄芪、15重量份的川芎、25重量份的丹参、20重量份的三七、10重量份的血竭和15重量份的当归制成。
5.一种权利要求1-4任一项所述中药组合物的制备方法，具体步骤如下：
(1)取黄芪药材粉碎，以10-14倍量的水回流提取三次，每次提取时间2h，过滤合并滤液，减压浓缩获得浸膏1；
(2)取白参、川芎、丹参、三七、血竭和当归药材，粉碎混匀，以6-10倍量的70％乙醇回流提取三次，每次提取时间2h，过滤合并滤液，减压浓缩获得浸膏2；
(3)将浸膏1和浸膏2合并即得所述中药组合物。
6.一种包含权利要求1-4任一项所述中药组合物的药物制剂，其由所述中药组合物和药学上可接受的辅料组成。
7.根据权利要求6所述的药物制剂，其特征在于，所述药物制剂为口服制剂，所述口服制剂可以是片剂、包衣片剂、散剂、颗粒剂、胶囊、口服液、丸剂、悬浮剂、乳剂等。
8.根据权利要求7所述的药物制剂，其特征在于，所述辅料选自淀粉、β-环糊精、糊精、卡波姆、微晶纤维素、羟丙基甲基纤维素、低取代羟丙基纤维素、羧甲基纤维素钙、聚乙二醇(PEG)、羧甲基纤维素钠、甲基纤维素、乙基纤维素、甘露醇、十二烷基硫酸钠、交联羧甲基纤维素钠、乳糖、聚乙烯吡咯烷酮(PVP)、交联聚乙烯吡咯烷酮、聚氧乙烯蓖麻油酸甘油酯、硬脂酸镁、滑石粉、微粉硅胶、阿斯巴甜、甜橙香精、碳酸氢钠、碳酸钠、肠溶包衣粉中的一种或几种。
9.根据权利要求8所述的药物制剂，其特征在于，所述口服制剂为颗粒剂，所述辅料由淀粉、糊精和聚氧乙烯蓖麻油酸甘油酯。具体地说，所述糊精、淀粉和聚氧乙烯蓖麻油酸甘油酯的重量比为1-5∶0.5-2∶0.2，优选为3∶1∶0.2。
10.根据权利要求8所述的药物制剂，其特征在于，在药物制剂中，所述中药组合物和辅料的重量比为1∶1-3，进一步地优选为1∶2。
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