CN113440574B - 一种中药组合物在制备治疗病毒性心肌炎药物中的应用 - Google Patents
一种中药组合物在制备治疗病毒性心肌炎药物中的应用 Download PDFInfo
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Abstract
本发明提供一种中药组合物在制备治疗病毒性心肌炎药物中的应用，所述药物是由以下重量份比例的原料制成：酸枣6‑36份、桑椹6‑36份、灵芝2‑12份、百合1‑6份、山楂2‑12份、茯苓1‑6份、陈皮1‑6份、菊花2‑12份、荷叶1‑6份，经试验证实，本发明药物可以显著提高临床疗效，改善心功能指标以及降低血血清炎性因子，充分证明本发明药物可以用于治疗病毒性心肌炎。
Description
技术领域
本发明涉及一种中药组合物的新用途，具体地，涉及一种中药组合物在制备治疗病毒性心肌炎药物中的应用。
背景技术
病毒性心肌炎（VMC）是指病毒感染引起的心肌局限性或弥漫性的急性或慢性炎症病变，属于感染性心肌疾病。在病毒流行感染期约有5%患者发生心肌炎，也可散在发病。临床表现轻重不同。根据典型的前驱感染病史；相应的临床表现；心电图、心肌损伤标志物、超声心动显示的心肌损伤证据考虑该诊断，确诊有赖于心内膜心肌活检。
近年来病毒性心肌炎的发病率逐年上升，但对于其发病机理尚不明确，目前无特异性治疗方法，治疗主要针对病毒感染和心肌炎症。VMC的治疗药物包括1、抗病毒药物如利巴韦林、更昔洛韦等，因病毒感染不同选择不同的抗病毒药物；2、免疫调节药物治疗如肾上腺皮质激素等；3、营养心肌治疗如二磷酸果糖、葡萄糖-胰岛素-氯化钾极化液等；自由基清除药物治疗如维生素C、维生素E、辅酶Q10等；5、丙种球蛋白治疗；6、中药治疗。
中医对本病的病因病机认识，古代医家认为本病多由外感六淫，正气虚损，温热邪毒乘虚侵犯于心，伤及心脉，造成气血阴阳的偏盛偏衰，与其产生瘀血、痰浊等相互为用，总属本虚标实之证。随着现代药物提取工艺和科学技术的飞跃发展，中药相关单体在细胞学、分子学等领域开展了大量相关研究，在抗病毒、防止心脏重构，免疫调节方面取得一定进展。相对于西药治疗，中药对于病毒性心肌炎的治疗，效果明显且不良反应较少。
发明内容
本发明涉及一种中药组合物的新用途，具体地，涉及一种中药组合物在制备治疗病毒性心肌炎药物中的应用。
本发明提供治疗病毒性心肌炎的中药组合物，该中药组合物是由如下重量份的原料药制成的：酸枣6-36份、桑椹6-36份、灵芝2-12份、百合1-6份、山楂2-12份、茯苓1-6份、陈皮1-6份、菊花2-12份、荷叶1-6份。
优选的中药组合物由如下重量份的原料药制成：酸枣30-36份、桑椹30-36份、灵芝10-12份、百合5-6份、山楂10-12份、茯苓5-6份、陈皮5-6份、菊花10-12份、荷叶5-6份。
优选的中药组合物由如下重量份的原料药制成：酸枣30份、桑椹30份、灵芝10份、百合5份、山楂10份、茯苓5份、陈皮5份、菊花10份、荷叶5份。
优选的中药组合物由如下重量份的原料药制成：酸枣36份、桑椹36份、灵芝10份、百合6份、山楂12份、茯苓6份、陈皮6份、菊花12份、荷叶6份。
本发明所述中药组合物的活性成分由以下步骤制成：
(1)按照原料药重量比例称取中药材，净选；
(2)将上述净选后药材混匀，粗粉，加9倍量水，浸泡1小时，加热煎煮2次，第一次1.5小时，第二次1小时，滤过，合并滤液，减压浓缩至60℃热测时相对密度为1.20-1.25的清膏，加乙醇静置、醇沉、过滤，滤液减压回收乙醇至无醇味，减压浓缩至60℃热测时相对密度1.02-1.06的流浸膏，干燥，即得活性成分。
本发明所述中药组合物的制剂剂型为胶囊剂、片剂、丸剂、口服液、软胶囊、微丸、滴丸。
本发明所述的口服液的制备方法是由以下步骤制成：
(1)按照原料药重量比例称取中药材，净选；
(2)将上述净选后药材混匀，粗粉，加9倍量水，浸泡1小时，加热煎煮2次，第一次1.5小时，第二次1小时，滤过，合并滤液，减压浓缩至 60℃热测时相对密度为1.20-1.25的清膏，加乙醇静置、醇沉、过滤，滤液减压回收乙醇至无醇味，减压浓缩至60℃热测时相对密度1.02-1.06的流浸膏，备用；
(3)将步骤(2)所得流浸膏中加入药学上所接收的防腐剂，调解PH值 至规定范围，加水调解浓度，搅匀、静置、滤过、灌封、灭菌，即得。
本发明所述药物在制备改善病毒性心肌炎心功能中的应用。
本发明所述药物在制备降低病毒性心肌炎血清炎性因子中的应用。
本发明所述血清炎性因子为白细胞介素-2、白细胞介素-10、肿瘤坏死因子-α。
本发明药物组合物方中，酸枣为君药，重在养心阴，安心神，以全酸枣入药，既广药源，又增效力；桑椹、灵芝、百合为臣药，补肝肾阴精，润肺荣百脉，益心血，使心之阴血充盛；山楂重在健脾消食后助后天运化以资化源，使营血充足，茯苓、陈皮使气血足而养心神，菊花滋填肾精，四者共为佐药；荷叶为使药，引诸脏之清气上荣于脑，使髓海得充，神气得养。诸药合用，补肾健脑，调和五脏功能，补中有通，益心血，养心神，五脏充盛，气血流畅，诸症自除，临床用于治疗病毒性心肌炎，取得了良好的效果。本发明配伍合理，简单易行，为纯中药制剂，不良反应小，可供病人长期使用。通过本研究发现本发明药物可以有效的治疗病毒性心肌炎，且具有较好的效果，可以提高患者的生活质量。
为证实本发明药物治疗病毒性心肌炎的疗效，用按实施例1制得的口服液（以下称本发明药物），进行以下临床试验研究。
试验例
1、资料与方法
1.1 一般资料
选取2017年1月至2019年12 月在河北以岭医院收治的100例病毒性心肌炎患者为研究对象，随机将其分为对照组和治疗组，各50例。对照组男27例，女23例；年龄20~74岁，平均年龄（44.6±3.78）岁；病程15~130 d，平均病程（63.56±8.74）d。研究组男26例，女24例；年龄19~75 岁，平均年龄（45.82±5.77）岁；病程17~144d，平均病程（65.27±6.22）d。两组患者的一般资料无显著差异（P＞0.05）。此次研究得到我院伦理委员会批准，患者及家属对本研究内容均知情同意。
1.2纳入病例标准
诊断均符合1999年关于成人急性病毒性心肌炎诊断参考标准和采纳世界卫生组织及国际心脏病学会联合会工作组关于心肌病定义和分类的意见制定的《急性病毒性心肌炎的诊断标准》，发病前有明确的病毒感染史；心电图显示心肌损伤。
1.3排除标准
①患有甲亢、β受体功能亢进及影响心脏的其它疾病；②婴儿、妊娠或哺乳期妇女，对本药过敏者；③合并有脑血管、肝、肾和造血系统等严重原发性疾病、精神病患者；④凡不符合纳入标准，未按规定用药，无法判断疗效或资料不全等影响疗效或安全性判断者。
1.4治疗方法
两组病例在入院后，均给予一般治疗（卧床休息、高蛋白、高维生素、易消化饮食），并常规给予能量合剂（5%葡萄糖注射液200mL，维生素C0.3g，肌苷0.4g,辅酶A100U,三磷酸腺苷40mg）及利巴韦林加入液体中静脉滴注，每日一次。治疗组在常规治疗基础上给予口服本发明药物2支/次，3次/日。疗程均为4周。
1.5疗效判定标准
综合疗效判定标准参照《中药新药临床研究指导原则》（第一辑）“中药新药治疗病毒性心肌炎的临床研究指导原则”制定。
①临床治愈：临床症状、体征消失，心电图及实验室检查恢复正常；
②显效：临床症状、体征基本消失，心电图及实验室检查基本恢复正常；
③有效：临床症状、体征有所改善，心电图及实验室检查各项指标有一定的改善；
④无效：临床症状、体征及心电图、实验室检查均无改善。
临床治疗总有效率=[（治愈例数+显效例数+有效例数）/总例数]×100%。
1.6观察指标
1.6.1观察治疗前后两组患者心功能指标，包括左室舒张末期内径（LVEDD）、左室收缩末期内径（LVESD）、左心室射血分数（LVEF），选用彩色多普勒超声仪进行检测。
1.6.2观察两组患者治疗前、后血清炎性因子白细胞介素-2（IL-2）、白细胞介素-10（IL-10）、肿瘤坏死因子-α（TNF-α）水平。采用酶联免疫吸附实验检测，选购上海恒远生物科技有限公司生产的试剂盒，严格遵照试剂盒说明书进行操作。
1.7统计学方法
使用SPSS20.0 统计学软件进行数据处理，计数资料用n%表示，用X2检验计量资料以均数±标准差（X ̅±s）表示，采用t 检验，以P<0.05 为差异具有统计学意义。
2结果
2.1临床疗效比较
经统计比较，治疗组患者总有效率明显高于对照组（P<0.05）。结果见表1。
2.2两组患者治疗前、后心功能指标比较
治疗前，两组患者各项心功能指标无显著差异（P＞0.05）；治疗后，两组各项心功能指标均改善，且治疗组优于对照组（P＜0.05）。见表2。
2.3两组患者治疗前、后血清IL-2、IL-10、TNF-α 水平比较
治疗前，两组IL-2、IL-10、TNF-α 水平比较，差异无统计学意义（P>0.05）；治疗后，两组IL-2、IL-10、TNF-α 水平均较治疗前明显降低，且治疗组低于对照组，差异具有统计学意义（P<0.05）。见表3。
2.4不良反应
对照组、实验组均未见不良反应。
3结论
本研究在常规治疗的基础上，加入本发明药物治疗，在提高临床疗效，改善心功能指标以及降低血血清炎性因子白细胞介素-2（IL-2）、白细胞介素-10（IL-10）、肿瘤坏死因子-α（TNF-α）水平等方面均优于单纯西医治疗，充分证明本发明药物可以用于治疗病毒性心肌炎。
具体实施方式
实施例1：
原料药配方为：酸枣30g 桑椹30g 灵芝10g 百合5g山楂10g 茯苓5g 陈皮5g 菊花10g 荷叶5g；
制备方法：
(1)按照处方量称取中药材，净选；
(2)将上述净选后药材混匀，粗粉，加9倍量水，浸泡1小时，加热煎 煮2次，第一次1.5小时，第二次1小时，滤过，合并滤液，减压浓缩至60 ℃热测时相对密度为1.20-1.25的清膏，加乙醇调节浓度至含醇量为70％，4℃以下静置24小时，过滤，滤液减压回收乙醇至无醇味，减压浓缩至60℃热测 时相对密度1.02-1.06的流浸膏，备用；
(3)将步骤(2)所得流浸膏中加入苯甲酸钠0.1g，调解PH值至3.5， 加水至100ml，搅匀、静置、滤过、灌封、灭菌，即得。
实施例2：
原料药配方为：酸枣36g 桑椹36g 灵芝10g 百合6g山楂12g 茯苓6g 陈皮6g 菊花12g 荷叶6g
制备方法：
(1)按照处方量称取中药材，净选；
(2)将上述净选后药材混匀，粗粉，加9倍量水，浸泡1小时，加热煎 煮2次，第一次1.5小时，第二次1小时，滤过，合并滤液，减压浓缩至60 ℃热测时相对密度为1.20-1.25的清膏，加95％乙醇调节浓度至75％，4℃以 下静置24小时，过滤，滤液减压回收乙醇至无醇味，减压浓缩至60℃热测 时相对密度1.02-1.06的流浸膏，备用；
(3)将步骤(2)所得流浸膏干燥、粉碎、制粒，按常规方法压成100片片剂。
实施例3：
原料药配方为：酸枣6g 桑椹36g 灵芝2g 百合6g山楂2g 茯苓6g 陈皮1g 菊花12g荷叶1g；
制备方法：
(1)按照处方量称取中药材，净选；
(2)将上述净选后药材混匀，粗粉，加9倍量水，浸泡1小时，加热煎 煮2次，第一次1.5小时，第二次1小时，滤过，合并滤液，减压浓缩至60 ℃热测时相对密度为1.20-1.25的清膏，加95％乙醇调节浓度至75％，4℃以 下静置24小时，过滤，滤液减压回收乙醇至无醇味，减压浓缩至60℃热测 时相对密度1.02-1.06的流浸膏，备用；
(3)将步骤(2)所得流浸膏中加入苯甲酸钠0.1％，调解PH值至规定范围， 加水至100ml，搅匀、静置、滤过、灌封、灭菌，即得。
实施例4：
原料药配方为：酸枣36g 桑椹6g 灵芝12g 百合1g山楂12g 茯苓1g 陈皮6g 菊花2g 荷叶6g；
制备方法：
(1)按照处方量称取中药材，净选；
(2)将上述净选后药材混匀，粗粉，加9倍量水，浸泡1小时，加热煎 煮2次，第一次1.5小时，第二次1小时，滤过，合并滤液，减压浓缩至60 ℃热测时相对密度为1.20-1.25的清膏，加95％乙醇调节浓度至75％，4℃以 下静置24小时，过滤，滤液减压回收乙醇至无醇味，减压浓缩至60℃热测 时相对密度1.02-1.06的流浸膏，备用；
(3)将步骤(2)所得流浸膏中加入苯甲酸钠0.1％，调解PH值至规定范围， 加水至100ml，搅匀、静置、滤过、灌封、灭菌，即得。
实施例5：
原料药配方为：酸枣18g 桑椹18g 灵芝7g 百合3g山楂7g 茯苓3g 陈皮3g 菊花7g荷叶3g；
制备方法：
(1)按照处方量称取中药材，净选；
(2)将上述净选后药材混匀，粗粉，加9倍量水，浸泡1小时，加热煎 煮2次，第一次1.5小时，第二次1小时，滤过，合并滤液，减压浓缩至60 ℃热测时相对密度为1.20-1.25的清膏，加95％乙醇调节浓度至75％，4℃以 下静置24小时，过滤，滤液减压回收乙醇至无醇味，减压浓缩至60℃热测 时相对密度1.02-1.06的流浸膏，备用；
(3)将步骤(2)所得流浸膏中加入苯甲酸钠0.1％，调解PH值至规定范围， 加水至100ml，搅匀、静置、滤过、灌封、灭菌，即得。
Claims (10)
1.一种中药组合物在制备治疗病毒性心肌炎药物中的应用，其特征在于该中药组合物是由如下重量份的原料药制成的：酸枣6-36份、桑椹6-36份、灵芝2-12份、百合1-6份、山楂2-12份、茯苓1-6份、陈皮1-6份、菊花2-12份、荷叶1-6份。
2.根据权利要求1所述的应用，其特征在于所述中药组合物由如下重量份的 原料药制成：酸枣30-36份、桑椹30-36份、灵芝10-12份、百合5-6份、山楂10-12份、茯苓5-6份、陈皮5-6份、菊花10-12份、荷叶5-6份。
3.根据权利要求1所述的应用，其特征在于所述中药组合物由如下重量份的原料药制成：酸枣30份、桑椹30份、灵芝10份、百合5份、山楂10份、茯苓5份、陈皮5份、菊花10份、荷叶5份。
4.根据权利要求1所述的应用，其特征在于所述中药组合物由如下重量份的 原料药制成：酸枣36份、桑椹36份、灵芝10份、百合6份、山楂12份、茯苓6份、陈皮6份、菊花12份、荷叶6份。
5.根据权利要求1-4中任一项所述的应用，其特征在于所述中药组合物的活性成分由以下步骤制成：
(1)按照原料药重量比例称取中药材，净选；
(2)将上述净选后药材混匀，粗粉，加9倍量水，浸泡1小时，加热煎煮2次，第一次1.5小时，第二次1小时，滤过，合并滤液，减压浓缩至60℃热测时相对密度为1.20-1.25的清膏，加乙醇静置、醇沉、过滤，滤液减压回收乙醇至无醇味，减压浓缩至60℃热测时相对密度1.02-1.06的流浸膏，干燥，即得活性成分。
6.根据权利要求1-4任一所述的应用，其特征在于所述中药组合物的制剂剂型为胶囊剂、片剂、丸剂、口服液。
7.根据权利要求6所述的应用，其特征在于所述的口服液的制备方法是由以下步骤制成：
(1)按照原料药重量比例称取中药材，净选；
(2)将上述净选后药材混匀，粗粉，加9倍量水，浸泡1小时，加热煎煮2次，第一次1.5小时，第二次1小时，滤过，合并滤液，减压浓缩至 60℃热测时相对密度为1.20-1.25的清膏，加乙醇静置、醇沉、过滤，滤液减压回收乙醇至无醇味，备用；
(3)将步骤(2)所得浸膏中加入药学上所接收的防腐剂，调节pH值 至规定范围，加水调解浓度，搅匀、静置、滤过、灌封、灭菌，即得。
8.根据权利要求1-4中任一项所述的应用，其特征在于所述药物在制备改善病毒性心肌炎心功能中的应用。
9.根据权利要求1-4中任一项所述的应用，其特征在于所述药物在制备降低病毒性心肌炎血清炎性因子中的应用。
10.根据权利要求9所述的应用，其特征在于所述血清炎性因子为白细胞介素-2、白细胞介素-10、肿瘤坏死因子-α。
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