CN105998244B - 一种用于慢性心衰的中药制剂 - Google Patents

一种用于慢性心衰的中药制剂 Download PDF

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CN105998244B
CN105998244B CN201610629849.4A CN201610629849A CN105998244B CN 105998244 B CN105998244 B CN 105998244B CN 201610629849 A CN201610629849 A CN 201610629849A CN 105998244 B CN105998244 B CN 105998244B
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吴伦
吴丽红
卞敬琦
匡洪尧
韩路拓
刘莉
谢宁
田振坤
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Heilongjiang University of Chinese Medicine
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Abstract

本发明涉及一种用于慢性心衰的中药组合物及其相关制剂，属于中药领域。其由中药组合物和辅料组成。所述中药提取物和辅料的重量比为10∶0.2～1.1；所述中药组合物优选由重量份为：黄芪20份、太子参20份、桂枝10份、淫羊藿15份、茯苓20份、葶苈子15份、白术15份、丹参15份、益母草15份、仙鹤草30份和甘草10份的中药材所制成。

Description

一种用于慢性心衰的中药制剂
技术领域
本发明涉及一种用于慢性心衰的中药组合物及其相关制剂，属于中药领域。
背景技术
心力衰竭是由于任何心脏结构或功能异常导致心室充盈或射血能力受损的一组复杂临床综合征，其主要临床表现为呼吸困难和活动耐量受限，以及液体潴留(肺淤血和外周水肿)。心衰为各种心脏疾病的严重和终末阶段，发病率高，是当今最重要的心血管病之一。
心力衰竭是现代医学的一个以病理生理变化为依据的病名，中医传统文献中并无此名，但是依据其临床表现及其特征，在数千年的历史发展中不乏对心力衰竭的描述和探索，心力衰竭多归属于中医“心悸”、“喘证”、“痰饮”、“水肿”、“胸痹”等疾病范畴。
参芪益心方是黑龙江中医药大学刘莉教授的临床经验方，刘莉教授参阅古籍，根据多年临床经验，归纳总结，针对心衰病因病机，提出了“益气温阳、活血利水”的治疗法则，依据此法组方而成参芪益心方。方药：黄芪20份、太子参20份、桂枝10份、淫羊藿15份、茯苓20份、葶苈子15份、白术15份、丹参15份、益母草15份、仙鹤草30份和甘草10份。方中太子参、黄芪为君药，益气温阳；制附子以温肾暖土，以助阳气；桂枝既能助制附子温阳通脉，还能平冲降逆，治疗“喘息咳唾”；丹参活血化瘀利水以治其标，葶苈子泄肺气之壅闭而通调水道，下气平喘；甘草以调和诸药。
虽然参芪益心方在临床上获得了极佳的疗效，但是由于其是传统中药煎剂，导致患者使用不便，并且煎剂的稳定性不佳，不利于参芪益心方的推广及临床应用。
发明内容
本发明的目的之一是提供一种用于心衰治疗的中药胶囊制剂，其由中药组合物和辅料组成。所述中药提取物和辅料的重量比为10∶0.2～1.1；所述中药组合物由重量份为：黄芪20份、太子参20份、桂枝10份、淫羊藿15份、茯苓20份、葶苈子15份、白术15份、丹参15份、益母草15份、仙鹤草30份和甘草10份的中药材所制成。
所述辅料选自淀粉、β-环糊精、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)、维生素E聚乙二醇琥珀酸酯、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、硬脂酸镁、滑石粉、微粉硅胶、阿斯巴甜、甜橙香精、碳酸氢钠、碳酸钠中的一种或几种。上述制剂的所用辅料及制备方法均可采用其常规的辅料和制备方法制得。
在一个实施方案中，所述中药组合物和辅料的重量比为10∶0.6。
在另一个实施方案中，所述辅料为微晶纤维素、维生素E聚乙二醇琥珀酸酯和阿巴斯甜，三者的重量比为1∶0.1～0.4∶0.2。
在一个具体地实施方案中，所述辅料为微晶纤维素、维生素E聚乙二醇琥珀酸酯和阿巴斯甜，三者的重量比为1∶0.3∶0.2。
本发明的目的之二是提供所述中药胶囊制剂在制备治疗心衰药物中的应用。
本发明通过大量试验研究摸索得到了辅料种类、配比及用量的最佳方案，采用上述辅料可克服中药胶囊制剂由于吸湿性而影响药物稳定性的问题，本发明的中药胶囊制剂极大的提高了该制剂的稳定性。
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中药胶囊的制备
(1)称取黄芪20g、桂枝10g、淫羊藿15g、茯苓20g、葶苈子15g、白术15g、益母草15g、仙鹤草30g和甘草10g；按配比粉碎后，分别以10倍量、10倍量和8倍量的水回流提取三次，提取时间每次为2h，过滤并合并滤液，减压回收得浸膏1；
称取15g丹参采用10倍量、10倍量和8倍量的80％乙醇在80℃下进行提取，时间为2h，减压回收得浸膏2；
(3)称取太子参20g，磨成细粉过200目筛；取浸膏1和浸膏2真空干燥得干粉，混匀，将太子参细粉和浸膏干粉与相应重量份的微晶纤维素、维生素E聚乙二醇琥珀酸酯和阿巴斯甜(按中药组合物与辅料重量比10∶0.6计，添加辅料量为2.2g，三者的重量比为1∶0.3∶0.2)混合，加60％乙醇适量制粒，干燥，灌装胶囊，即得(300mg/粒)。
实施例2中药胶囊稳定性考察
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℃放置36个月、45℃及相对湿度75％条件下放置120天的药物稳定性。采用HPLC法测定中药胶囊中黄芪甲苷和丹酚酸B的含量。
25℃放置36个月后各组中药有效成分含量(n＝10)
对比例1为将辅料中微晶纤维素替换为羟丙基甲基纤维素，其他辅料及方法同实施例1；
对比例2为将辅料中微晶纤维素替换为乳糖，其他辅料及方法同实施例1；
对比例3为将辅料中维生素E聚乙二醇琥珀酸酯替换为聚乙二醇4000，其他辅料及方法同实施例1；
对比例4为中药组合物与辅料的重量比为10∶1，其他辅料及方法同实施例1。
45℃及相对湿度75％条件下放置60天后各组中药有效成分含量(n＝10)
实施例3中药胶囊制剂内容物颗粒休止角测定
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，并且按照中国药典2010版附录I L项下有关规定测定样本的装量差异。
休止角 装量差异
实施例1 21° ±1.8％
对比例1 28° ±4.6％
对比例2 31° ±5.2％
对比例3 30° ±3.7％
对比例4 25° ±2.9％
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 (2)

1.一种用于心衰治疗的中药胶囊制剂，其由中药提取物和辅料组成，所述中药提取物和辅料的重量比为10∶0.6；所述中药提取物由重量份为：黄芪20份、太子参20份、桂枝10份、淫羊藿15份、茯苓20份、葶苈子15份、白术15份、丹参15份、益母草15份、仙鹤草30份和甘草10份的中药材所制成；
所述辅料为微晶纤维素、维生素E聚乙二醇琥珀酸酯和阿巴斯甜，三者的重量比为1∶0.3∶0.2。
2.权利要求1所述的中药胶囊制剂在制备治疗心衰药物中的应用。
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