CN116920047B - 一种新型冠状病毒感染相关心肌损伤的中药复方组合物及制备方法 - Google Patents
一种新型冠状病毒感染相关心肌损伤的中药复方组合物及制备方法 Download PDFInfo
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Abstract
本发明公开了一种新型冠状病毒感染相关心肌损伤的中药复方组合物及制备方法,所述中药复方组合物的有效成分组成及其质量份数为:红景天15~30份,生黄芪15~60份,炙黄芪15~60份,丹参15~30份,党参15~30份,麦冬20~60份,五味子6~10份,玉竹15~30份。本发明采用上述一种新型冠状病毒感染相关心肌损伤的中药复方组合物及制备方法,用于治疗新型冠状病毒感染相关心肌损伤气阴耗伤、心脉瘀阻证,针对胸闷、心悸、多汗、乏力诸证的基本病机,具有益气养阴,活血养心功效。
Description
技术领域
本发明属于中药复方组合物,尤其涉及一种新型冠状病毒感染相关心肌损伤的中药复方组合物及制备方法。
背景技术
目前COVID-19是如何引起心肌损伤,又是如何进展为心肌炎,其相关机制及病理生理改变目前仍未知。COVID-19引起心脏损伤的机制可能多方面的,可能不仅包括内皮炎或心肌炎,还包括由于氧供需不匹配、微血管血栓、全身性过度炎症反应和心肌缺血引起的心肌损伤。COVID-19相关心肌炎的预防和治疗仍是一大挑战,现代医学治疗以休息、对症支持处理为主,尚缺乏针对性治疗措施,是亟需开展研究的临床难点,而中医药在防治病毒性心肌炎方面已经显示出较大的优势。
病毒性心肌炎在古代文献中虽无明确记载,但历代文献中可散见对本病的论述,依据临床特点及发病原因等,中医学常将其归属于“温病”、“心悸”、“怔忡”、“胸痹”等范畴,有古籍记载可知,气阴两虚为发病之本,治法重在健脾补气,滋养心体,养阴活血。使肺脾气盛,营卫充沛,御邪有力,血运畅行,为治法之关键。
发明内容
本发明的目的是针对新型冠状病毒感染相关心肌损伤的临床防治难点,提供一种对新型冠状病毒感染相关心肌损伤有辅助治疗作用,具有益气养阴,活血养心功效的中药复方组合物及其制备方法。
为了实现上述目的,本发明提供了一种新型冠状病毒感染相关心肌损伤的中药复方组合物及制备方法,所述中药复方组合物的有效成分组成及其质量份数为:红景天15~30份,生黄芪15~60份,炙黄芪15~60份,丹参15~30份,党参15~30份,麦冬20~60份,五味子6~10份,玉竹15~30份。
优选的,所述中药复方组合物的制备方法包括以下步骤:(1)取红景天、生黄芪、炙黄芪、丹参、党参、麦冬、五味子、玉竹饮片,加水煎煮二次,合并煎液;(2)过滤煎液,并浓缩滤液,加入乙醇进行醇沉处理,滤去沉淀物,滤液回收并浓缩,得浸膏;(3)取步骤(2)得到的浸膏,与药用载体制备成型。
优选的,步骤(1)中煎煮时间为每次1~2小时。
优选的,步骤(2)中乙醇的体积浓度为85%。
优选的,步骤(2)中浓缩温度为80℃。
优选的,步骤(2)中浓缩至相对密度为1.30~1.36。
优选的,浸膏与药用载体制备成膏剂、口服液、颗粒剂、胶囊剂、片剂或滴丸剂。
因此,本发明采用上述的一种新型冠状病毒感染相关心肌损伤的中药复方组合物及制备方法,用于治疗新型冠状病毒感染相关心肌损伤气阴耗伤、心脉瘀阻证,针对胸闷、心悸、多汗、乏力诸证的基本病机,具有益气养阴,活血养心功效。
下面通过实施例,对本发明的技术方案做进一步的详细描述。
具体实施方式
以下通过实施例对本发明的技术方案作进一步说明。
除非另外定义,本发明使用的技术术语或者科学术语应当为本发明所属领域内具有一般技能的人士所理解的通常意义。
实施例一
一种新型冠状病毒感染相关心肌损伤的中药复方组合物及制备方法,按质量份数包括以下中药饮片成分:红景天15~30份,生黄芪15~60份,炙黄芪15~60份,丹参15~30份,党参15~30份,麦冬20~60份,五味子6~10份,玉竹15~30份。
该中药复方组合物的制备方法:(1)按以上所述的质量份数取红景天、生黄芪、炙黄芪、丹参、党参、麦冬、五味子、玉竹饮片,加水煎煮二次,每次1~2小时,合并煎液;(2)过滤煎液,浓缩滤液,加入体积浓度为85%乙醇进行醇沉处理,滤去沉淀物,滤液回收并80℃浓缩至相对密度1.30~1.36,得浸膏;(3)取步骤(2)得到的浸膏,与药学上可接受的载体制备成膏剂、口服液、颗粒剂、胶囊剂、片剂或滴丸剂型的药物。
以下通过临床试验、阐明本发明所述用于治疗一种新型冠状病毒感染相关心肌损伤的中药复方组合物的治疗效果。
实施例二
实验招募了52位符合诊断和入组标准的患者,以上患者年龄≥18岁,均为实验室确诊或临床确诊的新型冠状病毒感染患者,心肌肌钙蛋白呈阳性,具有心悸、发热、胸闷、乏力、多汗、小便赤、大便干结、舌红少苔、脉细数等症状。
实验方法:
(1)病例分组:将52例患者按照随机数字表法分为对照组和中药组。每组各26例。对照组男11例,女15例,年龄16~52岁,平均年龄(42.43±8.52)岁,病程4~27d,平均病程(13.44±6.72)d;中药组男14例,女12例,年龄17~62岁,平均年龄(44.36±7.94)岁,病程5~32d,平均病程(14.89±8.22)d。两组患者基线资料对比P>0.05,具有可比性。
(2)治疗方案:两组患者均按照《新型冠状病毒感染诊疗方案(试行第十版)》和《中医内科常见病诊疗指南(西医疾病部分):病毒性心肌炎》给予基础的治疗。
对照组患者常规营养心肌治疗:给予维生素C片口服100mg/次,3次/d;辅酶Q10片,每次10mg,每天3次,饭后服用;***美他嗪片,每次20mg,每天3次,餐后服用。连续治疗14天。重症者另予***磷酸钠注射液,每次20mg,加入5%葡萄糖注射液100mL中静脉滴注,每天1次,连续14d。
中药组患者在对照组基础上给予给予“红芪参脉饮”中药汤剂治疗,方剂组成为:红景天15g,生黄芪15g,炙黄芪15g,丹参15g,党参15g,麦冬20g份,五味子6g,玉竹15g。用500mL水将药物浸泡后,水煎30min,早晚各服用1次,1剂/d,连续治疗14天。
治疗期间患者如有发热症状,立即物理降温,必要时给予布洛芬或对乙酰氨基酚对症治疗。
实施例三
(1)疗效评价指标
①治疗效果对比
根据患者症状、体征及实验室检查结果评估患者治疗效果:患者心肌酶谱各指标正常、心电图正常,心悸、发热、胸闷、咽痛等症状消失,即为痊愈;患者心肌酶谱各指标正常、心电图大致正常,心悸、发热、胸闷、咽痛等缓解或偶有发生,即为有效;患者心肌酶、心电图异常,心悸、发热、胸闷、咽痛未缓解和改善,即为无效。总有效率=(痊愈+有效)/总例数×100%。
②中医症状评分对比
依据《中药新药临床研究指导原则》,对两组患者治疗前后心悸、发热、胸闷、咽痛等症状进行评分量化。
③心肌酶谱对比
所有患者治疗前后于清晨抽取空腹静脉血5mL,使用离心机3000r/min离心10min,取上层血清。全自动生化分析仪测定血清磷酸肌酸激酶(CK)、磷酸肌酸激酶同工酶(CK-MB)、乳酸脱氢酶(LDH)水平;酶联免疫吸附法测定血清肌钙蛋白-I(cTnI)和心型游离脂肪酸结合蛋白(H-FABP)水平。
④炎症指标对比
采取酶联免疫吸附法测定两组患者治疗前后白介素6(IL-6)、白介素8(IL-8)、肿瘤坏死因子α(TNF-α)水平。
(2)统计分析
应用SPSS21.0软件对数据进行统计学分析,计量资料符合正态分布,以均数±标准差()表示,组间均数比较采用t检验,计数资料比较采用χ2检验,以P<0.05为差异有统计学意义。
因此,本发明采用上述一种新型冠状病毒感染相关心肌损伤的中药复方组合物及制备方法,用于治疗新型冠状病毒感染相关心肌损伤气阴耗伤、心脉瘀阻证,针对胸闷、心悸、多汗、乏力诸证的基本病机,具有益气养阴,活血养心功效。
实施例四
实验结果:
(1)两组总体临床疗效比较:中药组有效率显著高于对照组(P<0.05),见表1。
表1两组总体疗效比较[n(%)]
;
(2)两组治疗前后中医症状积分变化比较:治疗前两组患者心悸、胸闷气短、乏力、自汗、发热咽痛、失眠等症状积分比较无显著性差异(P>0.05);治疗后各组积分较治疗前均下降,中药组治疗后各项症状积分均明显低于对照组(P<0.05),见表2。
表2两组治疗前后中医症状积分比较(,分)
;
注:较对照组治疗前,;较治疗前,&P<0.05;较对照组治疗后,#P<0.05。
(3)两组治疗前后心肌标志物指标变化:两组患者治疗前CK-MB、cTnI心肌酶指标比较无显著性差异(P>0.05);治疗后各组患者CK-MB、cTnI心肌酶指标均下降,中药组CK-MB、cTnI心肌酶指标优于对照组(P<0.05),见表3。
表3两组治疗前后心肌标志物指标比较()
;
注:较对照组治疗前,;较治疗前,&P<0.05;较对照组治疗后,#P<0.05。
(4)两组治疗前后血清炎性因子水平变化比较:治疗前,两组患者IL-6、IL-8、TNF-α水平比较无显著性差异(P>0.05);治疗后各组患者IL-6、IL-8、TNF-α水平均下降,中药组低于对照组(P<0.05),见表4。
表4两组治疗前后血清炎性因子水平变化(,ng/L)
;
注:较对照组治疗前,;较治疗前,&P<0.05;较对照组治疗后,#P<0.05。
以下进一步列举典型临床案例说明本发明的效果:
患者女性,42岁,COVID-19感染后胸闷心悸乏力1周。COVID-19感染后发热、咽痛、乏力3天,体温减退后,仍有乏力,并感胸闷、心悸、失眠、多汗,舌暗红,少苔,脉细数。CK-MB16U/L,cTnI286ng/L。心电图提示频发室性期前收缩。冠状动脉CTA未见血管异常。服用“红芪参脉饮”中药复方汤剂2周后,诸症皆消,舌淡苔薄白,脉象和缓。复查CK-MB82U/L,cTnI92ng/L;心电图提示正常范围,未见室性期前收缩发作。
最后应说明的是:以上实施例仅用以说明本发明的技术方案而非对其进行限制,尽管参照较佳实施例对本发明进行了详细的说明,本领域的普通技术人员应当理解:其依然可以对本发明的技术方案进行修改或者等同替换,而这些修改或者等同替换亦不能使修改后的技术方案脱离本发明技术方案的精神和范围。
Claims (3)
1.一种用于新型冠状病毒感染相关心肌损伤的中药复方组合物,其特征在于,所述中药复方组合物的有效成分组成及其质量份数为:红景天15~30份,生黄芪15~60份,炙黄芪15~60份,丹参15~30份,党参15~30份,麦冬20~60份,五味子6~10份,玉竹15~30份。
2.一种如权利要求1所述的用于新型冠状病毒感染相关心肌损伤的中药复方组合物的制备方法,其特征在于,所述中药复方组合物的制备方法包括以下步骤:(1)取红景天、生黄芪、炙黄芪、丹参、党参、麦冬、五味子、玉竹饮片,加水煎煮二次,合并煎液;(2)过滤煎液,并浓缩滤液,加入乙醇进行醇沉处理,滤去沉淀物,滤液回收并浓缩,得浸膏;(3)取步骤(2)得到的浸膏,与药用载体制备成型;
步骤(1)中煎煮时间为每次1~2小时;
步骤(2)中浓缩温度为80℃,浓缩至相对密度为1.30~1.36,乙醇的体积浓度为85%。
3.根据权利要求2所述的用于新型冠状病毒感染相关心肌损伤的中药复方组合物的制备方法,其特征在于:浸膏与药用载体制备成膏剂、口服液、颗粒剂、胶囊剂、片剂或滴丸剂。
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