CN115154481A - 一种用于防治动脉粥样硬化及冠心病的中药组合物 - Google Patents
一种用于防治动脉粥样硬化及冠心病的中药组合物 Download PDFInfo
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- CN115154481A CN115154481A CN202211086850.9A CN202211086850A CN115154481A CN 115154481 A CN115154481 A CN 115154481A CN 202211086850 A CN202211086850 A CN 202211086850A CN 115154481 A CN115154481 A CN 115154481A
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Abstract
本发明公开了一种用于防治动脉粥样硬化及冠心病的中药组合物，涉及中药技术领域。按照重量份包括以下成分：枸杞多糖、黄芪多糖、二苯乙烯苷、朝藿定B、朝藿定C、女贞苷G13、酸枣仁皂苷、黄精皂苷、红景天苷、金丝桃苷、丹酚酸B、齐墩果酸、异鼠李素、山楂黄酮、咖啡酰丁二胺、甜菜碱，斯皮诺素。通过特定配比混合后，得到疗效确切，无毒副作用，安全可靠的对于动脉粥状硬化和冠心病有较为显著的治疗效果的组合物。
Description
技术领域
本发明涉及中药技术领域，具体涉及一种用于防治动脉粥样硬化及冠心病的中药组合物。
背景技术
动脉粥样硬化(Atherosclerosis，AS)是一组称为动脉硬化的血管病中最常见的一种，是导致冠心病等心脑血管疾病的最主要的致病因素。作为动脉硬化中最常见而重要的类型，其特点是受累动脉的内膜有类脂质的沉着，复合糖类的积聚，继而纤维组织增生和钙沉着，并有动脉中层的病变。本病主要累及大型及中型的肌弹力型动脉，以主动脉、冠状动脉及脑动脉为多见，常导致管腔闭塞或管壁破裂出血等严重后果。发生在冠状动脉上的动脉粥样硬化称为冠状动脉粥样硬化，它是最常见的狭窄性冠状动脉疾病，特别是肌壁外冠状动脉支的动脉粥样硬化。冠状动脉近侧段之所以好发动脉粥样硬化是由于它比所有器官动脉都靠近心室，因而承受最大的收缩压撞击。再者，冠状动脉血管树由于心脏的形状而有多数方向改变，因此亦承受较大的血流剪应力。目前主要的治疗手段是使用血管生成抑制剂和降脂药物，目前中医药在防治动脉粥样硬化的研究已成为该领域研究的热点。
冠状动脉粥样硬化会导致冠心病、脑缺血，具有心脑血管病发病率高、致残率高、复发率高、病死率高和并发症多等特点。目前，治疗和预防动脉硬化、冠心病的药物例如阿司匹林、氯吡格雷、噻氯匹定、水蛭素、阿加曲班、比伐卢啶、雷米普利、培哚普利、β-受体阻滞剂、钙离子拮抗剂及硝酸酯类药物、依普利酮、尼可地尔等。以上各类药物虽有一定疗效，但均具有明显副作用，这也是西药的较大弊端。与之相比，中医药治疗动脉粥样硬化或高血压的历史源远流长，而且作为现代疾病综合治疗的一个重要方面，近年来越来越受到关注。结合现代中医药发展理论，从提高药物疗效、降低副作用的角度出发，经过对中药成分进行筛选提取和/或配伍制得的制剂，其副作用小，安全性高，具有西药所不具备的优势。但是，目前的中药研究中，单组分提取成分虽具有一定功效，但治疗效果有限，而多组分复方制剂依然存在针对特定疾病疗效不确切等问题。
发明内容
本发明的目的是提供一种用于防治动脉粥样硬化及冠心病的中药组合物，通过特定配比混合后，得到疗效确切，无毒副作用，安全可靠的对于动脉粥状硬化和冠心病有较为显著的治疗效果的组合物。
为实现上述发明目的，本发明的技术方案如下：
一方面，本发明提供一种中药组合物，按照重量份包括以下成分：枸杞多糖0.1-10份、黄芪多糖20-60份、二苯乙烯苷0.1-5份、朝藿定B 0.1-6份、朝藿定C 0.1-3份、女贞苷G13 0.1-1份、酸枣仁皂苷0.1-1份、黄精皂苷5-20份、红景天苷0.1-5份、金丝桃苷0.05-1份、丹酚酸B 0.5-10份、齐墩果酸0.1-2份、异鼠李素0.05-1份、山楂黄酮10-30份、咖啡酰丁二胺0.1-1.5份、甜菜碱0.5-8份，斯皮诺素0.05-3份。
优选地，按照重量份包括以下成分：枸杞多糖1-8份、黄芪多糖30-50份、二苯乙烯苷0.5-4份、朝藿定B 0.5-3份、朝藿定C 0.5-2份、女贞苷G13 0.1-0.5份、酸枣仁皂苷0.1-0.5份、黄精皂苷6-15份、红景天苷0.5-2份、金丝桃苷0.05-0.5份、丹酚酸B 2-8份、齐墩果酸0.1-1份、异鼠李素0.08-0.15份、山楂黄酮15-25份、咖啡酰丁二胺0.2-1份、甜菜碱1-5份，斯皮诺素0.05-1份。
进一步优选地，按照重量份包括以下成分：枸杞多糖2-4份、黄芪多糖35-45份、二苯乙烯苷1-3份、朝藿定B 1-2份、朝藿定C 1-1.5份、女贞苷G13 0.2-0.5份、酸枣仁皂苷0.1-0.3份、黄精皂苷7-10份、红景天苷0.8-1.2份、金丝桃苷0.1-0.3份、丹酚酸B 4-6份、齐墩果酸0.4-0.6份、异鼠李素0.08-0.12份、山楂黄酮16-20份、咖啡酰丁二胺0.2-0.4份、甜菜碱2-4份，斯皮诺素0.05-0.15份。
最优选地，按照重量份包括以下成分：枸杞多糖 3份、黄芪多糖 40份、二苯乙烯苷2份、朝藿定B 1.5份、朝藿定C 1.2份、女贞苷G13 0.3份、酸枣仁皂苷 0.2份、黄精皂苷 9份、红景天苷 1份、金丝桃苷0.2份、丹酚酸B 5份、齐墩果酸 0.5份、异鼠李素 0.1份、山楂黄酮 18份、咖啡酰丁二胺 0.3份、甜菜碱 3份、斯皮诺素 0.1份。
再一方面，本发明提供上述中药组合物的制剂，包括上述中药组合物和药学上的常规辅料。
所述制剂的剂型包括丸剂、颗粒剂、片剂、粉剂、胶囊剂、茶剂、口服液、锭剂、糖锭剂、酏剂、糖浆剂、乳剂、分散体和混悬液，进一步优选为颗粒剂、胶囊剂，更进一步优选为颗粒剂。
再一方面，本发明提供上述中药组合物或制剂在制备预防和/或治疗动脉粥样硬化药物中的应用。
最后，本发明提供上述中药组合物或制剂在制备预防和/或治疗冠心病药物中的应用。
本发明的有益效果为：
本发明的中药组合物对于动脉粥状硬化和冠心病有较为显著的治疗效果，同时疗效确切，无毒副作用，安全可靠。
具体实施方式
为了使本发明实现的技术手段、创作特征、达成目的与功效易于明白了解，下面结合具体实施例，进一步阐明本发明，但下述实施例仅为本发明的优选实施例，并非全部。基于实施方式中的实施例，本领域技术人员在没有做出创造性劳动的前提下所获得其它实施例，都属于本发明的保护范围。下述实施例中，若无特殊说明，所用的操作方法均为常规操作方法，所用设备均为常规设备，各个实施例所用设备材料均相同，制备方法为常规混匀。下述实施例中，所用水均为纯水。所用原料均为市售产品，不对本申请造成限制。
枸杞多糖CAS No：107-43-7
二苯乙烯苷CAS No：82373-94-2
朝藿定BCAS No：110623-73-9
朝藿定C CAS No：110642-44-9
女贞苷G13 CAS No：60037-39-0
齐墩果酸CAS No：508-02-1
异鼠李素CAS No：480-19-3
黄芪多糖CAS No：89250-26-0
山楂黄酮CAS No：36052-37-6
酸枣仁皂苷A CAS No：55466-04-1
咖啡酰丁二胺CAS No：29554-26-5
甜菜碱CAS No：107-43-7
黄精皂苷：CAS:144126-58-1
红景天苷CAS#: 10338-51-9
斯皮诺素CAS#: 72063-39-9
金丝桃苷CAS#: 482-36-0
丹酚酸B CAS#: 121521-90-2
实施例1
枸杞多糖 3份、黄芪多糖 40份、二苯乙烯苷 2份、朝藿定B 1.5份、朝藿定C 1.2份、女贞苷G13 0.3份、酸枣仁皂苷 0.2份、黄精皂苷 9份、红景天苷 1份、金丝桃苷0.2份、丹酚酸B 5份、齐墩果酸 0.5份、异鼠李素 0.1份、山楂黄酮 18份、咖啡酰丁二胺 0.3份、甜菜碱 3份、斯皮诺素0.1份。
实施例2
枸杞多糖2份、黄芪多糖35份、二苯乙烯苷1份、朝藿定B 1份、朝藿定C 1份、女贞苷G13 0.2份、酸枣仁皂苷0.1份、黄精皂苷7份、红景天苷0.8份、金丝桃苷0.3份、丹酚酸B 6份、齐墩果酸0.6份、异鼠李素0.12份、山楂黄酮20份、咖啡酰丁二胺0.4份、甜菜碱4份，斯皮诺素0.15份。
实施例3
枸杞多糖4份、黄芪多糖45份、二苯乙烯苷3份、朝藿定B 2份、朝藿定C 1.5份、女贞苷G13 0.5份、酸枣仁皂苷0.3份、黄精皂苷10份、红景天苷1.2份、金丝桃苷0.1份、丹酚酸B4份、齐墩果酸0.4份、异鼠李素0.08份、山楂黄酮16份、咖啡酰丁二胺0.2份、甜菜碱2份，斯皮诺素0.05份。
实施例4
枸杞多糖8份、黄芪多糖30份、二苯乙烯苷4份、朝藿定B 0.5份、朝藿定C 2份、女贞苷G13 0.1份、酸枣仁皂苷0.5份、黄精皂苷6份、红景天苷2份、金丝桃苷0.05份、丹酚酸B 8份、齐墩果酸0.1份、异鼠李素0.15份、山楂黄酮15份、咖啡酰丁二胺1份、甜菜碱1份，斯皮诺素1份。
对比例1（无朝霍定B、C）
枸杞多糖 3份、黄芪多糖 40份、二苯乙烯苷 2份、女贞苷G13 0.3份、酸枣仁皂苷0.2份、黄精皂苷 9份、红景天苷 1份、金丝桃苷0.2份、丹酚酸B 5份、齐墩果酸 0.5份、异鼠李素 0.1份、山楂黄酮 18份、咖啡酰丁二胺 0.3份、甜菜碱 3份、斯皮诺素0.1份。
对比例2（无异鼠李素、山楂黄酮、斯皮诺素）
枸杞多糖 3份、黄芪多糖 40份、二苯乙烯苷 2份、朝藿定B 1.5份、朝藿定C 1.2份、女贞苷G13 0.3份、酸枣仁皂苷 0.2份、黄精皂苷 9份、红景天苷 1份、金丝桃苷0.2份、丹酚酸B 5份、齐墩果酸 0.5份、咖啡酰丁二胺 0.3份、甜菜碱 3份。
对比例3（无丹酚酸B、齐墩果酸）
枸杞多糖 3份、黄芪多糖 40份、二苯乙烯苷 2份、朝藿定B 1.5份、朝藿定C 1.2份、女贞苷G13 0.3份、酸枣仁皂苷 0.2份、黄精皂苷 9份、红景天苷 1份、金丝桃苷0.2份、异鼠李素 0.1份、山楂黄酮 18份、咖啡酰丁二胺 0.3份、甜菜碱 3份、斯皮诺素0.1份。
对比例4（无枸杞多糖、黄芪多糖）
二苯乙烯苷 2份、朝藿定B 1.5份、朝藿定C 1.2份、女贞苷G13 0.3份、酸枣仁皂苷0.2份、黄精皂苷 9份、红景天苷 1份、金丝桃苷0.2份、丹酚酸B 5份、齐墩果酸 0.5份、异鼠李素 0.1份、山楂黄酮 18份、咖啡酰丁二胺 0.3份、甜菜碱 3份、斯皮诺素0.1份。
结果检测
将实施例1-4及对比例1-4的组合物混匀，制成粉剂，命名为康欣。临用时将粉剂以等量蒸馏水分散开，用时摇匀，4℃保存。评价实施例1-4及对比例1-4的组合物对动脉粥样硬化的治疗活性。
实验动物：选用8-10周龄雄性Wistar大鼠，体重200±20 g。
造模方法：选取健康大鼠，雌雄各半，按60万IU/kg的总剂量腹腔注射维生素D3，注射3d，同时给予高脂饲料(2g/100g胆固醇，0.5g/100g胆酸钠，10g/100g猪油，5g/100g蔗糖，0.2g/100g丙基硫氧嘧啶和82.3g/100g基础饲料)喂养，建立大鼠动脉粥样硬化（AS）模型。
给药：造模9周后，造模大鼠与正常大鼠各指标出现显著性差异，表示造模成功。继续高脂饲料喂养，连续给药8周。给药方式：灌胃给药，高、中、低剂量组给药实施例1配方组合物，高剂量0.9mg/kg、中剂量0.45mg/kg、低剂量0.23mg/kg；试验过程中，实施例1按照高、中、低剂量组给药，实施例2-4及对比例1-4均按低剂量(0.23mg/kg)给药。每日灌胃1次，灌胃体积3.6ml/kg。模型组灌胃同等体积的生理盐水。
将120只大鼠，分为10组，每组12只，其中一组设为正常对照组，正常饮食（不使用造模后大鼠），一组设为模型对照组，采用上述造模方法对大鼠进行造模，不给予任何药物；剩余各组采用上述造模方法对大鼠进行造模，给予各实例组中药物组合物进行灌胃，每日一次，直至造模结束。
分别采用全自动生化仪检测大鼠血清中总胆固醇含量（TC）、血清甘油三酯含量（TG）、血清低密度脂蛋白胆固醇（LDL-C）及高密度脂蛋白胆固醇含量（HDL-C）。此外，对大鼠体重进行监测，并称量肝脏重量，计算脏器指数。将结果统计至表1-2中。
表1.
（与正常组比较，a为P＜0.05，b为P＜0.01，与模型组比较，*为P＜0.05，**为P＜0.01）
表2.
（与正常组比较，a为P＜0.05，b为P＜0.01，与模型组比较，*为P＜0.05，**为P＜0.01）
由表1-2可知，相比于正常对照组，造模后模型对照组的大鼠的体重、脏器指数、总胆固醇含量（TC）、血清甘油三酯含量（TG）及血清低密度脂蛋白胆固醇（LDL-C）含量均上升，高密度脂蛋白胆固醇含量（HDL-C）含量下降，大鼠脂质代谢严重紊乱。相比较之下，在使用本发明实施例1-4中的组合物进行给药后的大鼠体重、脏器指数、总胆固醇含量（TC）、血清甘油三酯含量（TG）及血清低密度脂蛋白胆固醇（LDL-C）含量下降，高密度脂蛋白胆固醇含量（HDL-C）含量上升，脂质代谢稳定。可见，本发明中的组合物可通过平衡大鼠脂质代谢，发挥对动脉粥样硬化的治疗作用。其中，实施例1的效果优于其他实施例，在该配比下，本发明的组合物发挥出最佳疗效。对比例1-4表明，本申请组合物的所有成分作为一个整体，协同发挥对动脉粥样硬化的治疗作用，去除组分后会导致疗效显著降低。
以上所述仅为本发明的较佳实施例而已，并不用以限制本发明，凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。
Claims (10)
1.一种中药组合物，其特征在于，按照重量份包括以下成分：枸杞多糖0.1-10份、黄芪多糖20-60份、二苯乙烯苷0.1-5份、朝藿定B 0.1-6份、朝藿定C 0.1-3份、女贞苷G13 0.1-1份、酸枣仁皂苷 0.1-1份、黄精皂苷5-20份、红景天苷0.1-5份、金丝桃苷0.05-1份、丹酚酸B0.5-10份、齐墩果酸0.1-2份、异鼠李素0.05-1份、山楂黄酮10-30份、咖啡酰丁二胺0.1-1.5份、甜菜碱0.5-8份，斯皮诺素0.05-3份。
2.根据权利要求1所述的中药组合物，其特征在于，按照重量份包括以下成分：枸杞多糖1-8份、黄芪多糖30-50份、二苯乙烯苷0.5-4份、朝藿定B 0.5-3份、朝藿定C 0.5-2份、女贞苷G13 0.1-0.5份、酸枣仁皂苷 0.1-0.5份、黄精皂苷6-15份、红景天苷0.5-2份、金丝桃苷0.05-0.5份、丹酚酸B 2-8份、齐墩果酸0.1-1份、异鼠李素0.08-0.15份、山楂黄酮15-25份、咖啡酰丁二胺0.2-1份、甜菜碱1-5份，斯皮诺素0.05-1份。
3.根据权利要求2所述的中药组合物，其特征在于，按照重量份包括以下成分：枸杞多糖2-4份、黄芪多糖35-45份、二苯乙烯苷1-3份、朝藿定B 1-2份、朝藿定C 1-1.5份、女贞苷G13 0.2-0.5份、酸枣仁皂苷 0.1-0.3份、黄精皂苷7-10份、红景天苷0.8-1.2份、金丝桃苷0.1-0.3份、丹酚酸B 4-6份、齐墩果酸0.4-0.6份、异鼠李素0.08-0.12份、山楂黄酮16-20份、咖啡酰丁二胺0.2-0.4份、甜菜碱2-4份，斯皮诺素0.05-0.15份。
4.根据权利要求3所述的中药组合物，其特征在于，按照重量份包括以下成分：枸杞多糖 3份、黄芪多糖 40份、二苯乙烯苷 2份、朝藿定B 1.5份、朝藿定C 1.2份、女贞苷G13 0.3份、酸枣仁皂苷 0.2份、黄精皂苷 9份、红景天苷 1份、金丝桃苷0.2份、丹酚酸B 5份、齐墩果酸 0.5份、异鼠李素 0.1份、山楂黄酮 18份、咖啡酰丁二胺 0.3份、甜菜碱 3份、斯皮诺素 0.1份。
5.一种预防和/或治疗冠心病的药物，其特征在于，包括权利要求1-4任一项所述中药组合物。
6.根据权利要求5所述的药物，其特征在于，所述药物的剂型包括丸剂、颗粒剂、片剂、粉剂、胶囊剂、茶剂、口服液、锭剂、糖锭剂、酏剂、糖浆剂、乳剂、分散体和混悬液。
7.根据权利要求6所述的药物，其特征在于，所述药物的剂型为颗粒剂、胶囊剂。
8.根据权利要求7所述的药物，其特征在于，所述药物的剂型为颗粒剂。
9.权利要求1-4任一项所述中药组合物在制备预防和/或治疗动脉粥样硬化药物中的应用。
10.权利要求1-4任一项所述中药组合物在制备预防和/或治疗冠心病药物中的应用。
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