CN117414408A - 一种治疗急性心肌梗死心肌微循环障碍的中药颗粒及其制备方法 - Google Patents
一种治疗急性心肌梗死心肌微循环障碍的中药颗粒及其制备方法 Download PDFInfo
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Abstract
本发明提出了一种治疗急性心肌梗死心肌微循环障碍的中药颗粒及其制备方法,属于中药技术领域。由以下原料按重量份制备而成:桂枝15‑25份、栝蒌皮5‑15份、薤白15‑25份、法半夏10‑20份、桃仁5‑15份、砂仁5‑15份、苍术10‑20份、茯苓15‑25份、太子参15‑25份、丹参15‑25份、石菖蒲15‑20份、炙甘草3‑7份、生姜10‑20份、淫羊藿10‑20份。本发明中药颗粒具有活血化瘀,行气止痛的功效,能改善急性心肌梗死患者梗死心肌区域的炎性微环境,显著改善急性心肌梗死患者心肌微循环障碍、提高心脏射血分数及明显改善近远期预后。
Description
技术领域
本发明涉及中药技术领域,具体涉及一种治疗急性心肌梗死心肌微循环障碍的中药颗粒及其制备方法。
背景技术
急性心肌梗死是一种高发病率、高致死率的急危重症,是国际公认的亟需解决的医学难题。经皮冠脉介入手术治疗是国内外目前最直接的恢复冠脉血流再灌注的治疗手段。急性心肌梗死患者经皮冠状动脉介入术后存在着心肌再灌注损伤、冠脉无复流、心源性休克、恶性心律失常等严重并发症,是国际公认的亟需解决的医学难题。目前相关研究表明急性心肌梗死绝大多数并发症的根本原因为心肌微循环障碍。
中药药理作用具有多层次、多靶点、多指向、多覆盖的特点,被广泛的应用到急性心肌梗死的临床治疗。申请人结合多年的临床经验,将中医的痰瘀学说应用于急性心肌梗死,根据“脏气虚于内、痰瘀痹于中”的理论,提出了“气虚痰瘀”为急性心肌梗死心肌微循环障碍的主要中医病机的观点。
探索、发现、证实急性心肌梗死心肌微循环障碍新的有效预防/治疗方式或方法仍是一项迫在眉睫的艰巨科研攻关。传统的中药汤剂需临用新配,携带不方便,口服液易出现沉淀,并且挥发油对光热较敏感。
发明内容
本发明的目的在于提出一种治疗急性心肌梗死心肌微循环障碍的中药颗粒及其制备方法,具有活血化瘀,行气止痛的功效,能改善急性心肌梗死患者梗死心肌区域的炎性微环境,显著改善急性心肌梗死患者心肌微循环障碍、提高心脏射血分数及明显改善近远期预后。
本发明的技术方案是这样实现的:
本发明提供一种治疗急性心肌梗死心肌微循环障碍的中药颗粒,包括以下原料:桂枝、栝蒌皮、薤白、法半夏、桃仁、砂仁、苍术、茯苓、太子参、丹参、石菖蒲、炙甘草、生姜、淫羊藿。
作为本发明的进一步改进,由以下原料按重量份制备而成:桂枝15-25份、栝蒌皮5-15份、薤白15-25份、法半夏10-20份、桃仁5-15份、砂仁5-15份、苍术10-20份、茯苓15-25份、太子参15-25份、丹参15-25份、石菖蒲15-20份、炙甘草3-7份、生姜10-20份、淫羊藿10-20份。
作为本发明的进一步改进,由以下原料按重量份制备而成:桂枝20份、栝蒌皮10份、薤白20份、法半夏15份、桃仁10份、砂仁10份、苍术15份、茯苓20份、太子参20份、丹参20份、石菖蒲20份、炙甘草6份、生姜15份、淫羊藿15份。
本发明进一步保护一种上述治疗急性心肌梗死心肌微循环障碍的中药颗粒的制备方法,包括以下步骤:
S1.水提:将栝蒌皮、薤白、茯苓、太子参、丹参、石菖蒲、炙甘草、生姜、淫羊藿按比例称取,洗净,得到第一中药材加水浸泡后,加热煮沸提取,提取后停止加热,过滤,得到的提取液A,药渣加水混合,加热煮沸提取,提取后停止加热,过滤,得到的提取液B,将提取液A与B混合得到提取液C;
S2.回流提取:将桃仁、砂仁、法半夏、苍术、桂枝按比例称取,洗净,得到第二中药材加水混合,浸泡后,加热回流提取,提取后停止加热,得到芳香水D;
S3.中药的制剂:将提取液C低温减压浓缩,得到浸膏,冷却,再加入芳香水D,辅料喷雾制粒,干燥,得到治疗急性心肌梗死心肌微循环障碍的中药颗粒。
作为本发明的进一步改进,步骤S1中所述第一中药材与水的固液比为1:(10-12)g/mL。
作为本发明的进一步改进,步骤S1中所述所述药渣和水的固液比为1:(6-10)g/mL。
作为本发明的进一步改进,步骤S1中所述所述浸泡的时间为1-2h,所述加热煮沸提取的时间为50-70min。
作为本发明的进一步改进,步骤S2中所述第二中药材与水按照固液比1:(4-8)g/mL。
作为本发明的进一步改进,步骤S2中所述所述浸泡的时间为1-2h,所述加热回流提取的时间为50-70min。
作为本发明的进一步改进,步骤S3中所述低温减压浓缩的温度为70-80℃。
本发明具有如下有益效果:
方中以栝蒌、薤白为君,栝蒌理气宽胸,涤痰散结;薤白通阳散结,行气止痛,两药相配,一去痰结,一通阳气,相辅相成;臣以半夏、砂仁、苍术、茯苓、桃仁、丹参为主,半夏燥湿化痰,砂仁燥湿醒脾,苍术、茯苓健脾祛湿,增强祛痰之力;丹参活血化瘀止痛,且其不伤气血;佐以桂枝温通心阳,太子参益气健脾,石菖蒲开窍醒神,淫羊藿温肾助阳,生姜散寒行气;使以炙甘草调和诸药。全方共奏“袪痰活血通络”之功。
本发明中药颗粒在“脏气虚于内、痰瘀痹于中”的理论基础上,根据“气虚痰瘀”理论创建的新方药,该方具有活血化瘀,行气止痛的功效,能改善急性心肌梗死患者梗死心肌区域的炎性微环境,显著改善急性心肌梗死患者心肌微循环障碍、提高心脏射血分数及明显改善近远期预后。
本发明中药颗粒是发明人根据多年临床经验及科学研究结果创建的确有临床疗效的中药经验方,前期研究表明该药能够显著改善急性心肌梗死患者心肌微循环障碍、提高心脏射血分数及明显改善近远期预后。该中药颗粒为急性心肌梗死患者的治疗提供新的选择,且制备方法为急性心肌梗死患者提供更优的纯中药颗粒制剂,具有制剂成本低,并且服用、贮藏方便,易于推广应用等优点。
附图说明
为了更清楚地说明本发明实施例或现有技术中的技术方案,下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图仅仅是本发明的一些实施例,对于本领域普通技术人员来讲,在不付出创造性劳动性的前提下,还可以根据这些附图获得其他的附图。
图1为本发明测试例2中病例的检测结果图;
图2为本发明测试例2中评价指标对比图。
具体实施方式
下面将对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
实施例1
本实施例提供一种治疗急性心肌梗死心肌微循环障碍的中药颗粒。
原料组成(重量份):桂枝15份、栝蒌皮5份、薤白15份、法半夏10份、桃仁5份、砂仁5份、苍术10份、茯苓15份、太子参15份、丹参15份、石菖蒲15份、炙甘草3份、生姜10份、淫羊藿10份。
制备方法包括以下步骤:
S1.水提:将栝蒌皮、薤白、茯苓、太子参、丹参、石菖蒲、炙甘草、生姜、淫羊藿按比例称取,洗净,得到第一中药材加水混合,所述第一中药材与水的固液比为1:10g/mL,浸泡1h后,加热煮沸提取50min,提取后停止加热,过滤,得到的提取液A,药渣加水混合,所述所述药渣和水的固液比为1:6g/mL,加热煮沸提取50min,提取后停止加热,过滤,得到的提取液B,将提取液A与B混合得到提取液C;
S2.回流提取:将桃仁、砂仁、法半夏、苍术、桂枝按比例称取,洗净,得到第二中药材加水混合,所述第二中药材与水按照固液比1:4g/mL,浸泡1h后,加热回流提取50min,提取后停止加热,得到芳香水D;
S3.中药的制剂:将提取液C在70℃减压浓缩,得到浸膏,冷却,再加入芳香水D,辅料喷雾制粒,干燥,得到治疗急性心肌梗死心肌微循环障碍的中药颗粒。
实施例2
本实施例提供一种治疗急性心肌梗死心肌微循环障碍的中药颗粒。
原料组成(重量份):桂枝25份、栝蒌皮15份、薤白25份、法半夏20份、桃仁15份、砂仁15份、苍术20份、茯苓25份、太子参25份、丹参25份、石菖蒲20份、炙甘草7份、生姜20份、淫羊藿20份。
制备方法包括以下步骤:
S1.水提:将栝蒌皮、薤白、茯苓、太子参、丹参、石菖蒲、炙甘草、生姜、淫羊藿按比例称取,洗净,得到第一中药材加水混合,所述第一中药材与水的固液比为1:12g/mL,浸泡2h后,加热煮沸提取70min,提取后停止加热,过滤,得到的提取液A,药渣加水混合,所述所述药渣和水的固液比为1:10g/mL,加热煮沸提取70min,提取后停止加热,过滤,得到的提取液B,将提取液A与B混合得到提取液C;
S2.回流提取:将桃仁、砂仁、法半夏、苍术、桂枝按比例称取,洗净,得到第二中药材加水混合,所述第二中药材与水按照固液比1:8g/mL,浸泡2h后,加热回流提取70min,提取后停止加热,得到芳香水D;
S3.中药的制剂:将提取液C在80℃减压浓缩,得到浸膏,冷却,再加入芳香水D,辅料喷雾制粒,干燥,得到治疗急性心肌梗死心肌微循环障碍的中药颗粒。
实施例3
本实施例提供一种治疗急性心肌梗死心肌微循环障碍的中药颗粒。
原料组成(重量份):桂枝20份、栝蒌皮10份、薤白20份、法半夏15份、桃仁10份、砂仁10份、苍术15份、茯苓20份、太子参20份、丹参20份、石菖蒲20份、炙甘草6份、生姜15份、淫羊藿15份。
制备方法包括以下步骤:
S1.水提:将栝蒌皮、薤白、茯苓、太子参、丹参、石菖蒲、炙甘草、生姜、淫羊藿按比例称取,洗净,得到第一中药材加水混合,所述第一中药材与水的固液比为1:11g/mL,浸泡1.5h后,加热煮沸提取60min,提取后停止加热,过滤,得到的提取液A,药渣加水混合,所述所述药渣和水的固液比为1:8g/mL,加热煮沸提取60min,提取后停止加热,过滤,得到的提取液B,将提取液A与B混合得到提取液C;
S2.回流提取:将桃仁、砂仁、法半夏、苍术、桂枝按比例称取,洗净,得到第二中药材加水混合,所述第二中药材与水按照固液比1:5g/mL,浸泡1.5h后,加热回流提取60min,提取后停止加热,得到芳香水D;
S3.中药的制剂:将提取液C在75℃减压浓缩,得到浸膏,冷却,再加入芳香水D,辅料喷雾制粒,干燥,得到治疗急性心肌梗死心肌微循环障碍的中药颗粒。
该中药颗粒的制备方法,在同等条件下,与以往的技术相比,能提取出药物浓度是以往的技术的2倍;药物的有效浓度明显提高后,能更大程度的发挥药物的药效。
测试例1治疗急性心肌梗死心肌微循环障碍的中药颗粒改善对急性心肌梗死患者冠脉介入术后心肌灌注影响的研究
将实施例3制得的治疗急性心肌梗死心肌微循环障碍的中药颗粒进行研究。
1.1研究方案
20例接受急诊冠脉介入术的急性ST段抬高型心肌梗死患者被随机分为治疗急性心肌梗死心肌微循环障碍的中药颗粒组(术前顿服治疗急性心肌梗死心肌微循环障碍的中药颗粒8.8g,术后治疗急性心肌梗死心肌微循环障碍的中药颗粒4.4g/次,每日2次)和对照组。所有患者均服用阿司匹林、氯吡格雷和阿托伐他汀。
1.2两组的MBG分级、术后ST段回落百分比
与对照组相比,治疗急性心肌梗死心肌微循环障碍的中药颗粒组术后的MBG分级达到MBG 3级的患者比例较多P<0.05)。治疗急性心肌梗死心肌微循环障碍的中药颗粒组术后ST段回落百分比明显较对照组好,ST段回落百分比>70%的患者数较对照组多(χ2=4.103,P=0.04)。
测试例2典型案例
黄某,女,70岁。
主诉:反复气喘1年余,再发加重1月余。
既往史:既往2021年1月有“急性非ST段抬高型心肌梗死”病史,曾在南宁市中医药住院治疗(具体不详),好转后出院,出院后仍时有胸闷,未规律服用药物。有“呼吸衰竭”、“肺部感染”、“胸腔积液”、“血糖升高”病史。
患者介入术后长期服用实施例3制得的治疗急性心肌梗死心肌微循环障碍的中药颗粒,半年后复诊,经过精准辩证治疗及心脏康复调理,患者无明显不适,复查心脏彩超EF25%提升至EF46%(见图1),心肌酶、脑利钠肽前体测定、CTNT定量未见明显异常,心功能显著改善,且无任何不良事件发生(见图2)。在接受医护人员电话回访时,患者心情愉悦,表达了其及家属对疗效的认可。
测试例3典型案例
马某,男,67岁。
主诉:反复胸闷3月余,再发加重6天。
入院后予完善冠脉造影术明确诊断急性心肌梗死,行介入治疗,治疗上予抗血小板聚集,调脂稳斑等对症基础支持治疗。服用实施例3制得的治疗急性心肌梗死心肌微循环障碍的中药颗粒,离院后连续服用1月余,6个月随访病人复查心功能明显改善,心肌酶、脑利钠肽前体测定、CTNT定量未见明显异常,且无任何不良事件发生。
与以往技术相比,本发明能为急性心肌梗死心肌微循环障碍的治疗提供新的选择,该药具有“袪痰活血通络”之功,且全方具有能化瘀止痛且其不伤气血的优势。在保证质量稳定的前提下,为原发性肝癌患者提供更优的纯中药颗粒制剂。
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)
1.一种治疗急性心肌梗死心肌微循环障碍的中药颗粒,其特征在于,包括以下原料:桂枝、栝蒌皮、薤白、法半夏、桃仁、砂仁、苍术、茯苓、太子参、丹参、石菖蒲、炙甘草、生姜、淫羊藿。
2.根据权利要求1所述治疗急性心肌梗死心肌微循环障碍的中药颗粒,其特征在于,由以下原料按重量份制备而成:桂枝15-25份、栝蒌皮5-15份、薤白15-25份、法半夏10-20份、桃仁5-15份、砂仁5-15份、苍术10-20份、茯苓15-25份、太子参15-25份、丹参15-25份、石菖蒲15-20份、炙甘草3-7份、生姜10-20份、淫羊藿10-20份。
3.根据权利要求2所述治疗急性心肌梗死心肌微循环障碍的中药颗粒,其特征在于,由以下原料按重量份制备而成:桂枝20份、栝蒌皮10份、薤白20份、法半夏15份、桃仁10份、砂仁10份、苍术15份、茯苓20份、太子参20份、丹参20份、石菖蒲20份、炙甘草6份、生姜15份、淫羊藿15份。
4.一种如权利要求1-3任一项所述治疗急性心肌梗死心肌微循环障碍的中药颗粒的制备方法,其特征在于,包括以下步骤:
S1.水提:将栝蒌皮、薤白、茯苓、太子参、丹参、石菖蒲、炙甘草、生姜、淫羊藿按比例称取,洗净,得到第一中药材加水浸泡后,加热煮沸提取,提取后停止加热,过滤,得到的提取液A,药渣加水混合,加热煮沸提取,提取后停止加热,过滤,得到的提取液B,将提取液A与B混合得到提取液C;
S2.回流提取:将桃仁、砂仁、法半夏、苍术、桂枝按比例称取,洗净,得到第二中药材加水混合,浸泡后,加热回流提取,提取后停止加热,得到芳香水D;
S3.中药的制剂:将提取液C低温减压浓缩,得到浸膏,冷却,再加入芳香水D,辅料喷雾制粒,干燥,得到治疗急性心肌梗死心肌微循环障碍的中药颗粒。
5.根据权利要求4所述的制备方法,其特征在于,步骤S1中所述第一中药材与水的固液比为1:(10-12)g/mL。
6.根据权利要求4所述的制备方法,其特征在于,步骤S1中所述所述药渣和水的固液比为1:(6-10)g/mL。
7.根据权利要求4所述的制备方法,其特征在于,步骤S1中所述所述浸泡的时间为1-2h,所述加热煮沸提取的时间为50-70min。
8.根据权利要求4所述的制备方法,其特征在于,步骤S2中所述第二中药材与水按照固液比1:(4-8)g/mL。
9.根据权利要求4所述的制备方法,其特征在于,步骤S2中所述所述浸泡的时间为1-2h,所述加热回流提取的时间为50-70min。
10.根据权利要求4所述的制备方法,其特征在于,步骤S3中所述低温减压浓缩的温度为70-80℃。
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