CN113144087A - 一种活血化瘀的中药组合物 - Google Patents

一种活血化瘀的中药组合物 Download PDF

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CN113144087A
CN113144087A CN202110600588.4A CN202110600588A CN113144087A CN 113144087 A CN113144087 A CN 113144087A CN 202110600588 A CN202110600588 A CN 202110600588A CN 113144087 A CN113144087 A CN 113144087A
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时贞平
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Nanjing Zhengliang Pharmaceutical Technology Co Ltd
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Abstract

本发明提供了一种活血化瘀的中药组合物，由如下重量份数的原料制备得到：赤芍18‑22份、川芎12‑20份、丹参10‑14份、黄芪18‑22份、党参18‑22份、熟地12‑16份、白术18‑22份、淡豆豉8‑12份、牛蒡子8‑12份、连翘12‑16份、蝉蜕6‑10份、黄芩8‑12份、麦门冬16‑20份、玄参10‑14份、知母4‑6份、金银花18‑22份、防风2‑4份、白芥子8‑12份、旋复花8‑12份、甘草3‑5份，并采用了相应的制备方法，本发明用于治疗慢性咳嗽。

Description

一种活血化瘀的中药组合物
技术领域
本发明涉及中药技术领域，具体涉及一种活血化瘀的中药组合物。
背景技术
咳嗽多由六淫外邪侵入肺系，或者脏腑功能失调，内伤及肺，肺气不清，肺失宣肃而上逆，出现咳嗽或者咯吐痰液。中医认为，五脏六腑皆令人咳，又将咳嗽分为外感咳嗽和内伤咳嗽，外感咳嗽病程急，其病在肺，如果治疗不当，或过用苦寒、收涩之药，可由外感咳嗽转为慢性咳嗽，常反复发作、日久不愈，导致肺、肾、心、脾亏虚，气滞、痰凝、血瘀、水停导致肺胀，因此针对慢性咳嗽急需一种标本兼治的中药。
发明内容
发明目的：为了解决上述问题，本发明的目的在于提供一种标本兼治的活血化瘀中药组合物。
本发明的另一个目的在于提供一种活血化瘀的中药组合物制备方法和应用。
技术方案：本发明的目的是通过如下的方案实现的：
一种活血化瘀的中药组合物，由如下重量份数的原料制备得到：赤芍18-22份、川芎12-20份、丹参10-14份、黄芪18-22份、党参18-22份、熟地12-16份、白术18-22份、淡豆豉8-12份、牛蒡子8-12份、连翘12-16份、蝉蜕6-10份、黄芩8-12份、麦门冬16-20份、玄参10-14份、知母4-6份、金银花18-22份、防风2-4份、白芥子8-12份、旋复花8-12份、甘草3-5份。
一种活血化瘀的中药组合物，由如下重量份数的原料制备得到：赤芍20份、川芎16份、丹参12份、黄芪20份、党参20份、熟地14份、白术20份、淡豆豉10份、牛蒡子10份、连翘14份、蝉蜕8份、黄芩10份、麦门冬18份、玄参12份、知母5份、金银花20份、防风3份、白芥子10份、旋复花10份、甘草4份。
上述活血化瘀中药组合物的制备方法为：取上述中药，先加入乙醇提取，收集乙醇提取液，浓缩，干燥，得乙醇提取物；再将药渣进行水提取，收集水提取液，浓缩，喷雾干燥，得水提取物；合并乙醇提取物和水提取物，添加辅料，制备成固体制剂。
上述活血化瘀中药组合物的制备方法，先加入乙醇提取，所述乙醇提取时，采用回流提取的方式来进行，乙醇的加入重量为待提取物料总重量的8-10倍量，乙醇的质量百分比浓度为65％-85％，乙醇提取的次数为2-4次；再将药渣进行水提取，所述水提取时，采用煎煮的方式来进行，水的加入重量为待提取物料总重量的10-12倍量，水提取的次数为2-4次。
上述活血化瘀中药组合物的制备方法，喷雾干燥条件为：进风温度为120℃，出风温度为80℃，物料温度为70℃，雾化压力为0.4兆帕，喷雾速度为5ml/s。
上述活血化瘀中药组合物在制备治疗咳嗽药物中的应用。
上述活血化瘀中药组合物在制备治疗慢性咳嗽药物中的应用。
上述活血化瘀中药组合物在制备治疗内伤咳嗽药物中的应用。
上述活血化瘀中药组合物在制备减少咳嗽次数药物中的应用。
上述活血化瘀中药组合物在制备抗过敏药物中的应用。
所述药物均符合中国药典标准。
有益效果：本发明从六个方面治疗慢性咳嗽，其一活血化瘀，由于慢性咳嗽久病入络，多夹有瘀血，因此需要活血化瘀；其二补益肺气，久咳伤肺，肺气不足，或脾气虚弱，运化不健，肃降失司、卫气不固、腠理不密，需要补益肺气；其三清热肃肺，痰热壅肺，肺失宣降，痰热花火，灼肺伤络，气机不利，需要清热肃肺；其四养阴润肺，由于长期咳嗽，阴虚内燥，肺失滋润，口干舌燥，需养阴润肺；其五抗过敏，慢性咳嗽中变异性哮喘为多见，需要抗过敏；其六化气行水。长期咳嗽，水饮内停，肢体沉重、小便不利，需化气行水。方中赤芍、川芎、丹参活血化瘀，黄芪、党参、熟地、白术补益肺气，共为君药，淡豆豉、牛蒡子、连翘、蝉蜕、黄芩清热肃肺，麦门冬、玄参、知母养阴润肺共为臣药，金银花、防风抗过敏为佐药，白芥子、旋复花化气行水，甘草调和诸药为使药全方通过六个方面，共同治疗慢性咳嗽，取得良好效果。
具体实施方式
以下通过实施例形式，对本发明的上述内容再作进一步的详细说明，但不应将此理解为本发明上述主题的范围仅限于以下的实例，凡基于本发明上述内容所实现的技术均属于本发明的范围。
实施例1：取赤芍18份、川芎20份、丹参10份、黄芪22份、党参18份、熟地16份、白术18份、淡豆豉12份、牛蒡子8份、连翘16份、蝉蜕6份、黄芩12份、麦门冬16份、玄参14份、知母4份、金银花22份、防风2份、白芥子12份、旋复花8份、甘草5份，先乙醇提取，乙醇提取时，采用回流提取的方式来进行，乙醇的加入重量为待提取物料总重量的8倍量，乙醇的质量百分比浓度为85％，乙醇提取的次数为2次；再将药渣进行水提取，水提取时，采用煎煮的方式来进行，水的加入重量为待提取物料总重量的12倍量，水提取的次数为2次。喷雾干燥条件为：进风温度为120℃，出风温度为80℃，物料温度为70℃，雾化压力为0.4兆帕，喷雾速度为5ml/s。合并乙醇提取物和水提取物，添加淀粉，压片，制备成片剂。
实施例2：取赤芍22份、川芎12份、丹参14份、黄芪18份、党参22份、熟地12份、白术22份、淡豆豉8份、牛蒡子12份、连翘12份、蝉蜕10份、黄芩8份、麦门冬20份、玄参10份、知母6份、金银花18份、防风4份、白芥子8份、旋复花12份、甘草3份，先乙醇提取，乙醇提取时，采用回流提取的方式来进行，乙醇的加入重量为待提取物料总重量的10倍量，乙醇的质量百分比浓度为65％，乙醇提取的次数为4次；再将药渣进行水提取，水提取时，采用煎煮的方式来进行，水的加入重量为待提取物料总重量的10倍量，水提取的次数为4次。喷雾干燥条件为：进风温度为120℃，出风温度为80℃，物料温度为70℃，雾化压力为0.4兆帕，喷雾速度为5ml/s。合并乙醇提取物和水提取物，添加淀粉，灌胶囊，制备成胶囊剂。
实施例3：取赤芍20份、川芎16份、丹参12份、黄芪20份、党参20份、熟地14份、白术20份、淡豆豉10份、牛蒡子10份、连翘14份、蝉蜕8份、黄芩10份、麦门冬18份、玄参12份、知母5份、金银花20份、防风3份、白芥子10份、旋复花10份、甘草4份，先乙醇提取，乙醇提取时，采用回流提取的方式来进行，乙醇的加入重量为待提取物料总重量的10倍量，乙醇的质量百分比浓度为65％，乙醇提取的次数为4次；再将药渣进行水提取，水提取时，采用煎煮的方式来进行，水的加入重量为待提取物料总重量的10倍量，水提取的次数为4次。喷雾干燥条件为：进风温度为120℃，出风温度为80℃，物料温度为70℃，雾化压力为0.4兆帕，喷雾速度为5ml/s。合并乙醇提取物和水提取物，添加淀粉，制备成颗粒剂。
实施例4：本发明颗粒剂对慢性咳嗽大鼠的影响
1.动物：SD大鼠，雄性，重180-220g，由南京医科大学动物中心提供，生产许可证号SCXK(苏)2002-0031。
2.药物与试剂：实施例3制备得到的药物浸膏；念慈菴川贝枇杷膏，批号：20200518。
3.造模：参考湖南中医药大学学报(2010，39(9)：30-33)文献，以香烟刺激诱导咳嗽症状，以药物和冷热刺激建立大鼠慢性咳嗽模型。
4.给药方法：空白组不给药，其他大鼠造模成功后分为五组，每组10只，分别是模型组(生理盐水2.5ml/kg)、阳性药组(念慈菴川贝枇杷膏，2.5ml/kg)、本发明高剂量组(5ml/kg)、中剂量组(2.5ml/kg)、低剂量组(1.25ml/kg)。口服灌胃，早晚一次，连续2周。
5.实验过程：末次给药完成后8小时采用辣椒素溶液进行诱咳。辣椒素溶液浓度为每100ml含辣椒素0.15g，考察5分钟内每只大鼠的咳嗽次数，结果见表1。
6.实验结果见表1
表1本发明对慢性咳嗽大鼠咳嗽次数的影响
组别 数量 咳嗽次数
空白组 10 0±0
模型组 10 18.2±3.5##
阳性药组 10 12.5±4.8**
高剂量组 10 6.9±2.1**
中剂量组 10 8.1±2.6**
低剂量组 10 9.4±3.2**
与模型组比较，**P<0.01*P<0.05，与空白组比较，##P<0.01#P<0.05
7.实验结论：对慢性咳嗽大鼠咳嗽次数进行测定，首先表观观察发现模型组与空白组比较有显著性差异，说明造模成功，给药组和阳性药组较模型组能减少咳嗽次数，而且给药组随着剂量加大，效果更好，给药组效果优于阳性药组，说明本发明治疗咳嗽作用较好。
实施例5：本发明中药组合物对小鼠腹腔毛细血管通透性增高的影响
1.实验动物：ICR小鼠，雌雄各半，重18-22g，由南京医科大学动物中心提供，生产许可证号SCXK(苏)2002-0031。
2.药物与试剂：实施例3制备得到的药物浸膏；念慈菴川贝枇杷膏，批号：20200518。
3.实验过程：取小鼠50只，体重18～22g，雌雄各半，随机分成5组，即空白对照组、念慈菴川贝枇杷膏阳性药物对照组、本发明高剂量组(5ml/kg)、中剂量组(2.5ml/kg)、低剂量组(1.25ml/kg)，然后每组给予相应的本发明组合物(内服灌胃剂量为20ml/kg/d)，阳性对照组给予灌胃念慈菴川贝枇杷膏20ml/kg/d；空白对照组给予生理盐水(2.5ml/kg)，每天1次，给药容积为20ml/kg，连续3天，末次给药后1h，各组小鼠尾静脉注射0.5％伊文思蓝生理盐水溶液0.1ml/10g体重，然后立即腹腔注射0.6％醋酸0.2ml/只，20min后脱颈椎处死小鼠，剖开腹腔，用5ml生理盐水冲洗数次，收集洗液定容为10ml，离心1000rpm×5min，取上清液在分光光度计590nm处测OD值，比较各组间差异。
4.实验结果：见表2。
表2本发明对醋酸所致小鼠腹腔毛细血管通透性增高的影响(X±S)
组别 动物数(只) OD值
空白对照组 10 0.439±0.063
阳性药组 10 0.365±0.082*
高剂量组 10 0.316±0.091**
中剂量组 10 0.358±0.069*
低剂量组 10 0.368±0.065*
注：与生理盐水组比较，*P<0.05，**P<0.01
5.实验结论：过敏反应会引起细胞通透性增加，比如皮肤水肿，咳嗽也是一种过敏反应，本发明中药组合物均能显著抑制醋酸所致小鼠毛细血管通透性增高(P<0.01～0.05)，表明本发明中药组合物有抑制炎症渗出，具有抗过敏作用，并且随着剂量增加效果更好。
实施例6：本发明治疗慢性咳嗽的临床疗效
1.病例选择：所选病例均由呼吸科门诊确诊为慢性咳嗽的病人。年龄在20-55岁，共100例。
2.诊断标准：参照《中医内科常见病诊疗指南·咳嗽ZYYXH/T4～2008》(中华中医药学会，2008年)及《咳嗽中医诊疗专家共识》(中华中医药学会，2011年)。(1)咳嗽，咯痰或无痰。(2)病程>8周。
3.治疗方法：使用本发明实施例3制备的颗粒剂，每日3次，每次1包，疗程2周。
4.临床疗效判断标准：治愈：咳嗽及临床体征消失，且在两周以上未发作者。有效：咳嗽减轻，痰量减少。无效：症状无明显改变。
5.实验结果：见表3
表3本发明治疗慢性咳嗽的临床疗效观察
治愈 有效 无效 有效率(％)
本发明 28 67 5 95
6.实验结论：本发明治疗慢性咳嗽总有效率为95％，说明本发明效果良好。
当然，本发明创造并不局限于上述实施方式，熟悉本领域的技术人员在不违背本发明精神的前提下还可作出等同变形或替换，这些等同的变型或替换均包含在本申请权利要求所限定的范围内。

Claims (9)

1.一种活血化瘀的中药组合物，其特征在于，由如下重量份数的原料制备得到：赤芍18-22份、川芎12-20份、丹参10-14份、黄芪18-22份、党参18-22份、熟地12-16份、白术18-22份、淡豆豉8-12份、牛蒡子8-12份、连翘12-16份、蝉蜕6-10份、黄芩8-12份、麦门冬16-20份、玄参10-14份、知母4-6份、金银花18-22份、防风2-4份、白芥子8-12份、旋复花8-12份、甘草3-5份。
2.如权利要求1所述活血化瘀的中药组合物，其特征在于，由如下重量份数的原料制备得到：赤芍20份、川芎16份、丹参12份、黄芪20份、党参20份、熟地14份、白术20份、淡豆豉10份、牛蒡子10份、连翘14份、蝉蜕8份、黄芩10份、麦门冬18份、玄参12份、知母5份、金银花20份、防风3份、白芥子10份、旋复花10份、甘草4份。
3.如权利要求1所述活血化瘀的中药组合物，其特征在于，上述活血化瘀中药组合物的制备方法为：取上述中药，先加入乙醇提取，收集乙醇提取液，浓缩，干燥，得乙醇提取物；再将药渣进行水提取，收集水提取液，浓缩，喷雾干燥，得水提取物；合并乙醇提取物和水提取物，添加辅料，制备成固体制剂。
4.如权利要求3所述活血化瘀的中药组合物，其特征在于，上述活血化瘀中药组合物的制备方法，先加入乙醇提取，所述乙醇提取时，采用回流提取的方式来进行，乙醇的加入重量为待提取物料总重量的8-10倍量，乙醇的质量百分比浓度为65％-85％，乙醇提取的次数为2-4次；再将药渣进行水提取，所述水提取时，采用煎煮的方式来进行，水的加入重量为待提取物料总重量的10-12倍量，水提取的次数为2-4次。
5.如权利要求3所述活血化瘀的中药组合物，其特征在于，上述活血化瘀中药组合物的制备方法中喷雾干燥条件为：进风温度为120℃，出风温度为80℃，物料温度为70℃，雾化压力为0.4兆帕，喷雾速度为5ml/s。
6.如权利要求1所述活血化瘀的中药组合物在制备治疗咳嗽药物中的应用。
7.如权利要求1所述活血化瘀的中药组合物在制备治疗慢性咳嗽药物中的应用。
8.如权利要求1所述活血化瘀的中药组合物在制备减少咳嗽次数药物中的应用。
9.如权利要求1所述活血化瘀的中药组合物在制备抗过敏药物中的应用。
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