CN106620228A - 一种具有动脉扩张作用的中药组合物 - Google Patents
一种具有动脉扩张作用的中药组合物 Download PDFInfo
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Abstract
本发明公开一种具有动脉扩张作用的中药组合物。该组合物由土鳖虫、蒲黄、牡蛎、代赭石、青蒿、麦门冬、龟板、牛膝、生甘草、龙胆草、金铃子、全瓜蒌、薤白、制半夏、桂枝等21味原料药组成。本发明中药组合物的制备方法为:将牡蛎、代赭石和龟板用水先煎煮40分钟后,再加入其余原料药进行煎煮,过滤得滤液,合并滤液,静置,取上清液回收乙醇,并浓缩至清膏,最后加入糊精制成颗粒剂、片剂或胶囊剂。本发明中药组合物能够使身体每个部位均得到血液供应,加大动脉系统主动扩张的幅度,增大动脉系统负压力度,达到减轻心脏负荷,是动脉扩张法治疗心脏病的最佳选择。本发明中药组合物对治疗冠状动脉等引起的心脏病效果显著,无副作用。
Description
技术领域
本发明涉及一种中药组合物,特别是涉及一种具有动脉扩张作用的中药组合物。
背景技术
无论何种心脏病,治疗中减轻心脏负荷都是必要的。本发明人提出的动脉扩张法就是一个有效减轻心脏负荷的疗法。
传统理论把心脏视为一个送血的泵,靠心脏收缩的机械动力把血液送到全身各部位。因为心脏机械力消耗大,所以本身需要血量也多。冠状动脉是向心脏供血的管道。分左右两支,均直接开口于主动脉根部。左心室向全身输送的含氧血液经主动脉送出,约10%的动脉血优先进入左右冠状动脉输给了心脏。心脏大约等于本人拳大,而拳占身体的比重不足1%。这么大小的心脏却优先获得供给全身10%的血液,可见心脏消耗之大,血液供应之充足。尽管如此,本人认为仅靠心脏机械收缩的力量不可能把血液压到全身各处。手足指趾甲皱微循环的博动肉眼可见。那是身体的末梢,怎么可以想象心脏机械波动,推动血液灌注到身体末梢,而引起末梢那样明显的博动!不是心脏机械收缩压力所为,那是什么力量引起末梢微循环出现那样明显的博动?我认为动脉血管,从大动脉直至微血管的内膜存在一种感受器,它可以感受到心脏博动发生的物理信号,从而引起自身与心脏收缩相匹配的主动扩张,正是这个动脉系统主动扩张形成负压,与心脏收缩压力协同作用,才使动脉血液达于周身各处,直至达到末梢微循环,使身体每个部位均得到血液供应。加大动脉系统主动扩张的幅度,增大动脉系统负压力度,达到减轻心脏负荷,是动脉扩张法治疗心脏病的原理。
发明内容
本发明目的在于提供一种具有动脉扩张作用的中药组合物。
本发明是通过如下技术方案实现的:
本发明中药组合物的原料药组成为:
本发明中药组合物的原料药组成优选为:
本发明中药组合物的原料药组成优选为:
本发明中药组合物的原料药组成优选为:
本发明中药组合物的原料药组成优选为:
本发明中药组合物的制备方法为:将牡蛎、代赭石和龟板洗净用10-30倍量的水煎煮20-60分钟后,再加入其余原料药进行煎煮,第一次煎煮1-3小时,过滤,得滤液,药渣再用5-15倍量的水煎煮0.5-1.5小时,过滤得滤液,合并两次滤液,滤过,滤液浓缩至60-100℃测相对密度为1.15-1.18,乙醇使含醇量达65%,静置,取上清液回收乙醇,并浓缩至60-100℃测相对密度为1.25-1.30的清膏,最后加入糊精3-9重量份制成颗粒剂、片剂或胶囊剂。
本发明中药组合物的制备方法优选为:将牡蛎、代赭石和龟板洗净用20倍量的水煎煮40分钟后,再加入其余原料药进行煎煮,第一次煎煮2小时,过滤,得滤液,药渣再用10倍量的水煎煮1小时,过滤得滤液,合并两次滤液,滤过,滤液浓缩至80℃测相对密度为1.15-1.18,乙醇使含醇量达65%,静置,取上清液回收乙醇,并浓缩至80℃测相对密度为1.25-1.30的清膏,最后加入糊精6重量份制成颗粒剂、片剂或胶囊剂。
本发明中药组合物还可以按照常规工艺加入常规辅料制成临床接受的胶囊剂、片剂、丸剂、颗粒剂或口服液。
本发明中药组合物能够使身体每个部位均得到血液供应,加大动脉系统主动扩张的幅度,增大动脉系统负压力度,达到减轻心脏负荷,是动脉扩张法治疗心脏病的最佳选择。本发明中药组合物对治疗冠状动脉等引起的心脏病效果显著,无副作用。
下面实验例用于进一步说明本发明,但不限于本发明。
实验例一:临床试验
1、一般资料
选择200例冠状动脉粥样硬化性心脏病心绞痛患者,其中男100例,女100例,年龄40-70岁,平均55岁;200例患者均参照《实用内科学》和《现代冠心病》诊断标准确诊为冠状动脉粥样硬化性心脏病心绞痛。
2、诊断标准参照1979年WHO公布的冠心痛心绞痛诊断标准确诊,并且近期(3日内)有心绞痛连续发作3次上,无糖尿病、脑血管疾病及其他心、肝、肾等重要脏器疾病。
3、治疗方法
治疗组服用本发明胶囊剂(按照实施例1方法制备),每日服用二次,每次2粒,服用两个疗程,一疗程30天。
4、疗效标准
显效:静息检查时心电图恢复正常,心绞痛症状消失或发作次数减少80%以上;
有效:静息时检查心电图,缺血性ST段下降较治疗前回升0.5mV以上,主要导联T波变50%
以上,或者T波由平坦转为直立,心绞痛症状发作次数减少50%~80%;
无效:治疗后心绞痛发作次数较治疗前减少低于50%,静息时检查心电图与治疗前无甚变化;加重:治疗后心绞痛症状发作程度、次数和持续时间较治疗前有加重,mV。
静息检查心电图,
ST段下降较治疗前再次下降大于0.5。
5、治疗结果,见表1。
表1
组别 | 治疗人数 | 显效 | 有效 | 无效 | 加重 | 总有效率 |
治疗组 | 200 | 153 | 46 | 1 | 0 | 99.5% |
6、结论
200例患者服用本发明胶囊剂二个疗程(每个疗程30天),治疗结果显示,总有效率为99.5%。
实验例二:动物药效学试验
1、试验材料
Wistar大鼠,30只,200-250克,雌雄各半,北京医科大学实验动物中心提供。随
机分为空白对照组(尾静脉注射生理盐水)、模型组(尾静脉注射垂体后叶素)、本发
明组,每组鼠10只。
分组和剂量设置:空白对照组,生理盐水9ml/kg;模型组,生理盐水9ml/kg;本发明组(按照实施例1方法制备的胶囊,去掉胶囊壳)10mg/kg。插管灌胃给药,造模前连续给药3天,每天1次,最后给药后30min进行实验。
2、对心肌缺血大白鼠心电图的影响
大白鼠心肌缺血模型和心电图描记:3%戊巴比妥钠,20ml/kg腹腔注射麻醉,背部固定,连接6511型心电图机,描记基础II导联心电图。而后尾静脉注射垂体后叶素1.5u/kg,在注射后即刻、1min、2min、5min、10min、15min、30min 45min和60分种标记II导心电图,以观察心电图ST-T的改变。以ST-T上升1mv者定为缺血阳性改变。
本发明对心肌缺血大白鼠心电图的影响如表2和表3所示:
表2本发明对大鼠心肌缺血损伤程度的影响(mv,X±S)
组别 | Δ∑ST |
空白组 | |
模型组 | 9.05±1.89 |
本发明组 | 5.08±1.52** |
注:与模型组比较,**P<0.01。
表3各组心电图缺血阳性改变次数的比较(60min,X±S)
组别 | 阳性个数 |
空白组 | |
模型组 | 5.8±1.35 |
本发明组 | 2.15±1.21** |
注:与模型组比较,**P<0.01。
由表2和表3表明,造模组注射垂体后叶素后,在观察60min内,II导心电图ST-T升高非常明显;空白组大白鼠II导心电图在标记过程中变化不明显;本发明组与模型组相比,II导心电图ST-T升高幅度明显下降(P<0.01)。II导心电图ST-T升高的阳性个数,本发明组与模型组相比,皆明显降低(P<0.01)。
3、对心肌缺血大鼠血小板膜糖蛋白GMP-140的影响
血浆血小板颗粒膜糖蛋白(GMP-140)的测定:术后第三天收集血液标本,加入含2%EDTA-Na2抗凝剂的试管,4℃,3,000×g离心10min。将血浆移至另一干净试管,-20℃贮存。按试剂盒说明书在自动免疫γ计数仪上进行放免分析。
本发明对心肌缺血大鼠血小板膜糖蛋白GMP-140的影响结果如表4所示:
表4芎丹胶囊对心肌缺血大鼠血小板膜糖蛋白(X±S)的影响
注:与模型组比较,**P<0.01。
由表4表明,注射垂体叶素后60min,模型组大鼠血小板膜糖蛋白GMP-140血浆浓度和GMP-140的分子数皆较空白组明显升高(P<0.01);本发明组大鼠血小板膜糖蛋白GMP-140血浆浓度和GMP-140的分子数皆较空白组比较没有显著差异;本发明组大鼠血小板膜糖蛋白GMP-140分子数较模型组明显降低(P<0.01)。
4、对心肌缺血大白鼠心肌酶的影响
心肌酶检测参照体外临床诊断试剂盒介绍方法,在意大利公司生产的FT-1半自动化生化分析仪上测定。体外临床诊断试剂盒,由北京中生生物工程高科技公司提供。
本发明组对心肌缺血大白鼠心肌酶的影响结果如表5所示:
表5芎丹胶囊对心肌缺血大鼠血清心肌酶的影响(X±S)
组别 | CK(IU/L) | LDH(IU/L) | GOT(IU/L) |
空白组 | 811.4±195.98** | 763.12±121.41** | 132.1±17.98 |
模型组 | 1633.1±243.12 | 1241.35±238.42 | 175.2±31.78 |
本发明组 | 795.48±188.76** | 758.42±128.41** | 129.58±17.95** |
注:与模型组比较,**P<0.01。
由表5表明,造模组大白鼠心肌细胞CK、LDH和GOT的血清活性,较空白组皆明显升高(P<0.01);本发明组大白鼠心肌细胞CK、LDH和GOT的血清活性,较空白组比较没有显著差异;本发明组与造模组相比,CK活性皆明显降低(P<0.01)。
下述实施例均能实现上述实验例的效果。
具体实施方式
实施例1胶囊剂
将牡蛎、代赭石和龟板洗净用20倍量的水煎煮40分钟后,再加入其余原料药进行煎煮,第一次煎煮2小时,过滤,得滤液,药渣再用10倍量的水煎煮1小时,过滤得滤液,合并两次滤液,滤过,滤液浓缩至80℃测相对密度为1.15-1.18,乙醇使含醇量达65%,静置,取上清液回收乙醇,并浓缩至80℃测相对密度为1.25-1.30的清膏,最后加入糊精6kg制成胶囊。0.5g/粒,一日二次,每次2粒。
实施例2片剂
将牡蛎、代赭石和龟板洗净用15倍量的水煎煮50分钟后,再加入其余原料药进行煎煮,第一次煎煮1.5小时,过滤,得滤液,药渣再用12倍量的水煎煮0.8小时,过滤得滤液,合并两次滤液,滤过,滤液浓缩至90℃测相对密度为1.15-1.18,乙醇使含醇量达65%,静置,取上清液回收乙醇,并浓缩至70℃测相对密度为1.25-1.30的清膏,最后加入糊精4kg制成片剂。一日两次,每次2片。
实施例3颗粒剂
将牡蛎、代赭石和龟板洗净用25倍量的水煎煮30分钟后,再加入其余原料药进行煎煮,第一次煎煮2.5小时,过滤,得滤液,药渣再用8倍量的水煎煮1.2小时,过滤得滤液,合并两次滤液,滤过,滤液浓缩至70℃测相对密度为1.15-1.18,乙醇使含醇量达65%,静置,取上清液回收乙醇,并浓缩至90℃测相对密度为1.25-1.30的清膏,最后加入糊精8kg制成颗粒剂。10g/袋,一日两次,每次1袋。
实施例4口服液
上述药物按照常规工艺加入常规辅料制成口服液。
实施例5丸剂
上述药物按照常规工艺加入常规辅料制成丸剂。
Claims (10)
1.一种具有动脉扩张作用的中药组合物,其特征在于,该组合物的原料药组成为:
2.如权利要求1所述的中药组合物,其特征在于该组合物的原料药组成为:
3.如权利要求1或2所述的中药组合物,其特征在于该组合物的原料药组成为:
4.如权利要求1所述的中药组合物,其特征在于该组合物的原料药组成为:
5.如权利要求1所述的中药组合物,其特征在于该组合物的原料药组成为:
6.如权利要求1-5之一所述的中药组合物,其特征在于该组合物的制备方法为:将牡蛎、代赭石和龟板洗净用10-30倍量的水煎煮20-60分钟后,再加入其余原料药进行煎煮,第一次煎煮1-3小时,过滤,得滤液,药渣再用5-15倍量的水煎煮0.5-1.5小时,过滤得滤液,合并两次滤液,滤过,滤液浓缩至60-100℃测相对密度为1.15-1.18,乙醇使含醇量达65%,静置,取上清液回收乙醇,并浓缩至60-100℃测相对密度为1.25-1.30的清膏,最后加入糊精3-9重量份制成颗粒剂、片剂或胶囊剂。
7.如权利要求6所述的中药组合物,其特征在于该组合物的制备方法为:将牡蛎、代赭石和龟板洗净用20倍量的水煎煮40分钟后,再加入其余原料药进行煎煮,第一次煎煮2小时,过滤,得滤液,药渣再用10倍量的水煎煮1小时,过滤得滤液,合并两次滤液,滤过,滤液浓缩至80℃测相对密度为1.15-1.18,乙醇使含醇量达65%,静置,取上清液回收乙醇,并浓缩至80℃测相对密度为1.25-1.30的清膏,最后加入糊精6重量份制成颗粒剂、片剂或胶囊剂。
8.如权利要求1-5之一所述的中药组合物,其特征在于该组合物按照常规工艺加入常规辅料制成临床接受的胶囊剂、片剂、丸剂、颗粒剂或口服液。
9.如权利要求1-4之一所述的中药组合物在制备治疗具有动脉扩张作用的药物中的应用。
10.如权利要求1-4之一所述的中药组合物在制备治疗冠状动脉粥样硬化性心脏病、心绞痛或心肌缺血的药物中的应用。
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CN103977255A (zh) * | 2014-05-17 | 2014-08-13 | 邴学华 | 一种治疗冠状动脉粥样硬化性心脏病心绞痛的中药制剂 |
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