CN116570702B - 一种抗射血分数保留型心力衰竭的中药组合物及其应用 - Google Patents
一种抗射血分数保留型心力衰竭的中药组合物及其应用 Download PDFInfo
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Abstract
本发明提供了一种抗射血分数保留型心力衰竭的中药组合物及其应用,属于医药技术领域。本发明中抗射血分数保留型心力衰竭的中药组合物命名为“八味心气方”,由以下重量份数的原料组分构成:桂枝1~5份;党参1~5份;丹参1~5份;干姜1~5份;麦冬1~5份;白术1~5份;五味子1~5份;甘草1~5份。本发明的“八味心气方”配伍科学,君药为桂枝,温阳血脉;臣药为党参和丹参,其中党参益气生津,丹参温通血脉;佐药为干姜、麦冬、白术、五味子,其中干姜温通血脉,麦冬、白术、五味子养阴生津;使药为甘草,调和、缓急。且试验证明,本发明“八味心气方”具有组方科学、用药讲究、使用安全和制备简单等优点,具有良好的应用前景。
Description
技术领域
本发明属于医药技术领域,尤其涉及一种抗射血分数保留型心力衰竭的中药组合物及其应用。
背景技术
心力衰竭是指由于心脏的舒张功能和/或收缩功能发生障碍引起的心脏循环症候群。其中射血分数保持在50%以上的称为射血分数保留型心力衰竭(Heart Failure withPreserved Ejection Fraction,HFpEF)。根据流行病学研究,HFpEF发病率占心力衰竭总发病率的40%~50%,其死亡率与射血分数降低型心力衰竭(HFrEF)相似,并且随着人口老龄化、慢性阻塞性肺病、肥胖和高血压等合并症的持续流行而增加。由于HFpEF病理生理机制复杂,导致目前治疗方法局限,且效果不佳,是目前心血管领域中“最大的未得到满足的医疗需求”。
目前对于HFpEF的干预手段有限,已知对射血分数降低型心力衰竭有效的治疗手段对HFpEF却无确定效果。已有报道可以通过口服中药联合西药治疗显著提高HFpEF患者的临床疗效、改善心功能指标、提高运动耐力及生活质量。但仍有必要开发一种即能够有效改善心脏功能指标且又安全且毒副作用小的中药。
发明内容
为了解决上述技术问题,本发明提供了一种抗射血分数保留型心力衰竭的中药组合物及其应用。本发明中抗射血分数保留型心力衰竭的中药组合物命名为“八味心气方”,由以下重量份数的原料组分构成:桂枝1~5份;党参1~5份;丹参1~5份;干姜1~5份;麦冬1~5份;白术1~5份;五味子1~5份;甘草1~5份。本发明的“八味心气方”配伍科学,君药为桂枝,温阳血脉;臣药为党参和丹参,其中党参益气生津,丹参温通血脉;佐药为干姜、麦冬、白术、五味子,其中干姜温通血脉,麦冬、白术、五味子养阴生津;使药为甘草,调和、缓急。且试验证明,本发明“八味心气方”具有组方科学、用药讲究、使用安全和制备简单等优点,具有良好的应用前景。
为了实现上述目的,本发明采用了以下技术方案:
本发明提供了一种抗射血分数保留型心力衰竭(HFpEF)的中药组合物,包括以下重量份数的原料组分:桂枝1~5份;党参1~5份;丹参1~5份;干姜1~5份;麦冬1~5份;白术1~5份;五味子1~5份;甘草1~5份。
优选的,所述中药组合物包括以下重量份数的原料组分:桂枝2份;党参2份;丹参2份;干姜2份;麦冬2份;白术2份;五味子1份;甘草1份。
本发明还提供了一种所述中药组合物在制备抗射血分数保留型心力衰竭药物中的应用。
优选的,所述应用中抗射血分数保留型心力衰竭药物的剂型为颗粒剂、片剂或胶囊剂。
本发明还提供了一种所述应用中抗射血分数保留型心力衰竭药物的制备方法:将所述组分混合后用水煎煮,然后取煎煮液,最后将所述煎煮液制成所述剂型。
优选的,所述组分在混合之前还分别包括洗净、烘干、粉碎的步骤。
优选的,所述组分混合后煎煮时与水的质量比为1:5~10,煎煮时间为30min~2h。
优选的,所述组分混合后煎煮时与水的质量比为1:6~9,煎煮时间为40min~1.5h。
优选的,所述组分混合后煎煮时与水的质量比为1:7,煎煮时间为1h。
优选的,所述煎煮液在制成所述剂型前还包括将所述煎煮液经喷雾干燥制成固体粉末的步骤。
与现有技术相比,本发明具有如下技术效果:
本发明的“八味心气方”配伍科学,君药为桂枝,温阳血脉;臣药为党参和丹参,其中党参益气生津,丹参温通血脉;佐药为干姜、麦冬、白术、五味子,其中干姜温通血脉,麦冬、白术、五味子养阴生津;使药为甘草,调和、缓急。且试验证明,“八味心气方”可以通过改善左心室的功能,进而缓解射血分数保留型心衰的发生;“八味心气方”不仅能改善心肌肥大,也能改善心肌细胞的病变和长期由心肌负荷过大造成的损伤,且在具有良好干预效果的同时,也具有良好的安全性。因此本发明的“八味心气方”具有组方科学、用药讲究、使用安全和制备简单等优点,具有良好的应用前景。
附图说明
图1为本发明实施例1中各组小鼠的处理结果,其中:a、b为四周后整体心脏肥大程度的评估结果;c为二维心动超声图;d为射血分数;e为TissueDoppler彩超图;f.E/e’值(与Model组比较,*p<0.05,**p<0.01,***p<0.001,****p<0.0001);
图2为本发明实施例2中各组小鼠心脏病理HE染色结果图(20倍);
图3为本发明实施例3中各组小鼠心脏Masson染色结果图(40倍)。
具体实施方式
以下实施例用于说明本发明,但不用来限制本发明的范围。在不背离本发明精神和本质的情况下,对本发明方法、步骤或条件所作的修改或替换,均属于本发明的范围。以下实施例中使用的试剂和仪器均可由市售获得,实施例中使用的方法如无特别说明,与常规使用的方法一致。
下面结合实施例,对本发明的技术方案进行进一步详细阐述。
实施例1
取如下重量份数的原料:桂枝2份;党参2份;丹参2份;干姜2份;麦冬2份;白术2份;五味子1份;甘草1份。将各原料洗净、烘干、粉碎后混合,加入到混合原料7倍重量的水中,煎煮1h,收集煎煮液,喷雾干燥后得固体粉末,制成颗粒剂。
为了评价本发明中药组合物干预HFpEF的效果,选用HFpEF模型小鼠进行效果评价。实验动物选用C57小鼠,体重20-25g克,分别设置Sham组、Model组、BWXQKL组和Dapaglifiozin组。经过在干净的SPF级聚丙烯笼子中适应性喂养3天后(温度和环境:室温,12小时光/暗循环)后,model组、Dapagliflozin组和ZYZH组进行单肾切除术,并在背部植入微型泵,泵以0.3ug/h的速度持续输注醛固酮四周。造模后进行随机分组。造模后连续灌胃给药28天,具体剂量如下:Dapagliflozin(n=9,1.5167x10-3mg/g·d-1),Sham(n=9,等剂量的生理盐水);model(n=9,等剂量的生理盐水);ZYZH(n=9,人等效剂量中药颗粒)。四周之后,处死实验动物。
收集各组实验动物心脏及胫骨,进行称重。其中Sham组为假手术组,也就是空白对照组,Model组为模型处组,BWXQKL组为实验组,也就是“八味心气方”干预组,Dapaglifiozin组为达格列净阳性药干预组(下同)。具体结果如图1所示。
经过醛固酮持续输注后,如图1a、b结果所示,小鼠的心脏重量(Heart weight)以及心脏重量与胫骨长(Tibialength)的比值分析显示,模型组的心脏重量相较于假手术组有着显著升高,这表明发生了明显的心脏/心肌肥大。经过阳性药的干预后,心脏的重量下降。同时,中药组合物“八味心气方”(BWXQKL)干预组的小鼠心脏重量也回调到了接近于假手术组的水平。同样的情况也发生在心脏重量/胫骨长的结果中。经过阳性药和“八味心气方”的干预后,指标回调。这两个数据的结果表明,心脏肥大在治疗过后有所改善。
二维心动超声结果显示(图1c、d),四组的心脏搏动并无明显的差异,射血分数(Ejection Fraction,EF)值各组之间也没有明显差异。这说明模型符合射血分数保留型心力衰竭的特征。
Tissue Doppler心动超声结果显示(图1e、f),模型组中的e’和a’峰出现了倒置,且峰型出现了异常。这表明模型组小鼠心脏的舒张功能出现了障碍,左心室功能不足。同时,结合Power Doppler结果,统计了E/e’的比值。结果显示,模型组的比值显著高于假手术组的比值,而“八味心气方”干预之后有了显著回调。表明“八味心气方”可以通过改善左心室的功能缓解射血分数保留型心衰的发生。
实施例2
取如下重量份数的原料:桂枝2份;党参2份;丹参2份;干姜2份;麦冬2份;白术2份;五味子1份;甘草1份。将各原料洗净、烘干、粉碎后加入至6倍重量的水中,煎煮1h,收集提取液,喷雾干燥后得固体粉末,制成颗粒剂。
选用HFpEF模型小鼠评价本发明中药组合物干预HFpEF的实际效果,造模方法和用药方法与实施例1相同,处死实验动物,收集实验动物心脏,进行病理HE染色观察。具体结果如图2所示。
经过醛固酮持续输注后,如图2HE染色结果所示,模型组心肌组织中局部可见心肌纤维变性,胞质中可见较小的圆形空泡(黑色箭头)。假手术组的心肌细胞排列紧密,没有明显的病变。阳性药和中药组合物“八味心气方”(BWXQKL)干预组的心肌细胞尽管没有假手术组排列的那么紧密,但心肌细胞的形态正常,并无明显的病变。这表明“八味心气方”不仅能改善心肌肥大,也能改善心肌细胞的病变和长期由心肌负荷过大造成的损伤。且在具有良好干预效果的同时,也具有良好的安全性。由此可见,本发明中药组合物具有疗效确切和使用安全之特点。
实施例3
取如下重量份数的原料:桂枝2份;党参2份;丹参2份;干姜2份;麦冬2份;白术2份;五味子1份;甘草1份。将各原料洗净、烘干粉碎后加入7倍重量的水中,煎煮1h,收集提取液,喷雾干燥后得固体粉末,制成颗粒剂。
选用HFpEF模型小鼠评价本发明中药组合物干预HFpEF的实际效果。造模方法和用药方法与实施例1相同,处死实验动物,收集实验动物心脏,进行病理Masson染色观察。具体结果如图3所示。
从图3可以看出,经过醛固酮持续输注后,模型组心肌组织中细胞间隙均为蓝色,表明有间质纤维化发生。假手术组的大部分均为红色,没有明显的病变。阳性药和中药组合物“八味心气方”(BWXQKL)干预组的心肌细胞蓝色区域明显少于模型组,并无明显的病变。这表明“八味心气方”不仅能改善心肌肥大,也能改善心肌细胞的病变和长期由心肌负荷过大造成的损伤。同时具有良好的干预效果和良好的安全性。由此可见,本发明中药组合物具有疗效确切和使用安全之特点。
以上所述的实施例仅是对本发明的优选方式进行描述,并非对本发明的范围进行限定,在不脱离本发明设计精神的前提下,本领域普通技术人员对本发明的技术方案做出的各种变形和改进,均应落入本发明权利要求书确定的保护范围内。
Claims (10)
1.一种抗射血分数保留型心力衰竭(HFpEF)的中药组合物,其特征在于,由以下重量份数的原料组分制成:桂枝1~5份;党参1~5份;丹参1~5份;干姜1~5份;麦冬1~5份;白术1~5份;五味子1~5份;甘草1~5份。
2.根据权利要求1所述的中药组合物,其特征在于,由以下重量份数的原料组分制成:桂枝2份;党参2份;丹参2份;干姜2份;麦冬2份;白术2份;五味子1份;甘草1份。
3.权利要求1~2任一所述的中药组合物在制备抗射血分数保留型心力衰竭药物中的应用。
4.根据权利要求3所述的应用,其特征在于,所述应用中抗射血分数保留型心力衰竭药物的剂型为颗粒剂、片剂或胶囊剂。
5.权利要求4所述的应用中抗射血分数保留型心力衰竭药物的制备方法,其特征在于,所述制备方法为:将所述组分混合后用水煎煮,然后取煎煮液,最后将所述煎煮液制成所述剂型。
6.根据权利要求5所述的制备方法,其特征在于,所述组分在混合之前还分别包括洗净、烘干、粉碎的步骤。
7.根据权利要求6所述的制备方法,其特征在于,所述组分混合后煎煮时与水的质量比为1:5~10,煎煮时间为30 min~2 h。
8.根据权利要求7所述的制备方法,其特征在于,所述组分混合后煎煮时与水的质量比为1:6~9,煎煮时间为40 min~1.5 h。
9.根据权利要求8所述的制备方法,其特征在于,所述组分混合后煎煮时与水的质量比为1:7,煎煮时间为1 h。
10.根据权利要求9所述的制备方法,其特征在于,所述煎煮液在制成所述剂型前还包括将所述煎煮液经喷雾干燥制成固体粉末的步骤。
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