CN107970355A - 一种用于治疗冠心病、心绞痛的组合物 - Google Patents
一种用于治疗冠心病、心绞痛的组合物 Download PDFInfo
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Abstract
本发明提供一种用于治疗冠心病、心绞痛的组合物。该组合物主要由丹参、三七、延胡索、人参和川芎等原料药按照不同的重量份数制备而成。该组合物对冠心病和心绞痛具有很好的治疗效果。
Description
技术领域
本发明涉及中药领域,特别涉及一种用于治疗冠心病、心绞痛的组合物。
背景技术
冠状动脉粥样硬化性心脏病是冠状动脉血管发生动脉粥样硬化病变而引起血管腔狭窄或阻塞,造成心肌缺血、缺氧或坏死而导致的心脏病,常常被称为“冠心病”,但是冠心病的范围较为广泛,还包括炎症、栓塞等导致的管腔狭窄或闭塞,世界卫生组织将冠心病分为5大类:无症状心肌缺血、心绞痛、心肌梗死、缺血性心力衰竭和猝死,临床中常常将其分为稳定性冠心病和急性冠状动脉综合征。
心绞痛是冠状动脉供血不足、心肌急剧或暂时缺血与缺氧所引起的发作性胸痛或胸部不适,心绞痛是心脏缺血反射到身体表面所感觉的疼痛,特点为前胸阵发性、压榨性疼痛,可伴有其他症状,疼痛主要位于胸骨后部,可放射至心前区与左上肢,劳动或情绪激动时常发生,每次发作持续3-5分钟,可数日一次,也可一日数次,休息或用硝酸酯类制剂后症状消失,本病多见于男性,多数40岁以上,劳累、情绪激动、饱食、受寒、阴雨天气、急性循环衰竭等为常见诱因。
目前,临床治疗冠心病心绞痛的方式主要有药物治疗和手术治疗,手术治疗费用较高,并且常伴有胸闷胸痛等副作用。常见的治疗药物有硝酸酯类药物、β受体阻断剂等,上述药物容易产生耐药性,且副作用大;此外,现有技术中公开了许多用于治疗冠心病心绞痛的中药,例如:CN103784820B公开了用于治疗心血瘀阻型冠心病的中药配方,该中药配方由丹参、银杏叶和延胡索等中药组成,对心血瘀阻型冠心病具有一定的疗效,但该中药配方成分复杂,且效果不显著。
发明内容
为了解决上述技术问题,本发明提供了一种用于治疗冠心病、心绞痛的组合物,该组合物疗效好、治愈率高。
本发明具体技术方案如下:
本发明提供了一种治疗冠心病、心绞痛的组合物,该组合物主要由下列重量份的原料制备而成:
其中,炙甘草采用2015年版《中国药典》中的方法对药材进行炮制,本发明通过大量的试验得出,采用以上原料药组成的组合物协同作用,能够有效的治疗冠心病、心绞痛。
进一步的改进,该组合物由下列重量份的原料药制备而成:
进一步的改进,组合物还包括如下重量份的原料:
萹蓄50-100常山50-100。
本发明在组合物中加入了上述两味原料药后,不但进一步提高了其治疗冠心病、心绞痛的功效,此外还起到治疗鼻炎的功效。
进一步的改进,组合物由下列重量份的原料制备而成:
进一步的改进,组合物由如下方法制备而成:
1)将半夏用姜汁炒制阴干,将枳实、元胡醋制后炒干,将水蛭用滑石粉炒制,将当归酒制后阴干;
2)将步骤1)的药物与剩余重量份的药物混匀后粉碎,过100目筛,即得组合物。
进一步改进,步骤1)进一步包括如下步骤:
a.按照重量份数称取半夏放置于锅内,将0.5-0.8倍重量的生姜捣烂,加入与生姜同重量比例的水形成姜汁,将姜汁覆盖于半夏的表面,120-200℃条件下炒制1-1.5h,取出放凉,室温下阴干,得半夏姜制品;
b.按照重量份数称取枳实和元胡放置于高压锅内,将枳实和元胡浸泡在0.5-1倍重量的醋中,浸泡时间为1-2h,浸泡完毕后,将枳实和元胡在150-250℃条件下焖制3-5h,炒干,即得混合醋制品;
c.按照重量份数称取水蛭,称取0.5倍重量的滑石粉放置于锅内,在200-250℃条件下翻炒10min,再将水蛭倒入锅内,与滑石粉一起翻炒0.5-1h,阴干,得水蛭炮制品;
d.按照重量份数称取当归放置于砂锅内,在砂锅内加入0.5倍量的黄酒浸泡1-2h,将砂锅转移至蒸锅内,在150-200℃条件下蒸制1h,阴干,即得当归酒制品;
e.将步骤a、b、c、d所得的药物与剩余重量份的药物混匀后粉碎,过100目筛,即得组合物。
另一方面,本发明还提供了一种用于治疗冠心病、心绞痛的组合物的制备方法,包括如下步骤:
a.按照重量份数称取半夏放置于锅内,将0.5-0.8倍重量的生姜捣烂,加入与生姜同重量比例的水形成姜汁,将姜汁覆盖于半夏的表面,120-200℃条件下炒制1-1.5h,取出放凉,室温下阴干,得半夏姜制品;
b.按照重量份数称取枳实和元胡放置于高压锅内,将枳实和元胡浸泡在0.5-1倍重量的醋中,浸泡时间为1-2h,浸泡完毕后,将枳实和元胡在150-250℃条件下焖制3-5h,炒干,即得混合醋制品;
c.按照重量份数称取水蛭,称取0.5倍重量的滑石粉放置于锅内,在200-250℃条件下翻炒10min,再将水蛭倒入锅内,与滑石粉一起翻炒0.5-1h,阴干,得水蛭炮制品;
d.按照重量份数称取当归放置于砂锅内,在砂锅内加入0.5倍量的黄酒浸泡1-2h,将砂锅转移至蒸锅内,在150-200℃条件下蒸制1h,阴干,即得当归酒制品;
e.按照重量份数称取步骤a-d制得的半夏姜制品、混合醋制品、水蛭炮制品、当归酒制品和剩余原料药,混匀后放置于中药提取罐中,在100℃条件下提取3次,每次30min,得水提取液;
f.将步骤e制得的水提取液接种于益生菌培养基中进行培养,过滤,得培养液,培养条件为:起始pH值为4.6,温度为35℃,摇床转速为150转/分钟,培养时间为2天,培养基由重量份数为3的三聚磷酸钠、重量份数为5的糖蜜、重量份数为2的啤酒酵母菌和重量份数为3的鼠李糖乳杆菌组成;
g.将步骤f制得的培养液浓缩,放置于烘箱内,在45℃条件下烘干,即得组合物。
本发明通过以上方法制备的组合物可显著提高组合物中活性成分的含量,使制备的组合物对冠心病、心绞痛具有更高的治疗效果。
本发明还提供了一种水丸,包括上述组合物、辅料和蒸馏水,组合物、辅料和蒸馏水的重量份数比为100:2-5:25。
进一步的改进,辅料包括重量份数为1-3的无水乳糖、0.5-1的磷酸二氢钙和0.5-1的微晶纤维素。
本发明通过在水丸中加入无水乳糖、磷酸二氢钙和微晶纤维素的混合物,可降低水丸的吸湿性,从而防止水丸返潮,进而延长其保质期。
本发明提供一种用于治疗冠心病、心绞痛的组合物,该中药组合物对治疗心脉瘀阻型胸痹心痛,即现代医学冠心病、心绞痛、心肌供血不足、心律失常等心血管病症等有明显疗效,同时还能够起到治疗鼻炎的疗效。
具体实施方式
实施例1
一种组合物,该组合物由下列重量份的成分组成:
实施例2
实施例3
一种组合物,该组合物由下列重量份的成分组成:
该组合物的制备方法为:
a.按照重量份数称取半夏放置于锅内,将0.5倍重量的生姜捣烂,加入与生姜同重量比例的水形成姜汁,将姜汁覆盖于半夏的表面,120℃条件下炒制1h,取出放凉,室温下阴干,得半夏姜制品;
b.按照重量份数称取枳实和元胡放置于高压锅内,将枳实和元胡浸泡在0.5倍重量的醋中,浸泡时间为2h,浸泡完毕后,将枳实和元胡在150℃条件下焖制5h,炒干,即得混合醋制品;
c.按照重量份数称取水蛭,称取0.5倍重量的滑石粉放置于锅内,在200℃条件下翻炒10min,再将水蛭倒入锅内,与滑石粉一起翻炒1h,阴干,得水蛭炮制品;
d.按照重量份数称取当归放置于砂锅内,在砂锅内加入0.5倍量的黄酒浸泡1h,将砂锅转移至蒸锅内,在200℃条件下蒸制1h,阴干,即得当归酒制品;
e.按照重量份数称取步骤a-d制得的半夏姜制品、混合醋制品、水蛭炮制品、当归酒制品和剩余原料药,混匀后放置于中药提取罐中,在100℃条件下提取3次,每次30min,得水提取液;
f.将步骤e制得的水提取液接种于益生菌培养基中进行培养,过滤,得培养液,培养条件为:起始pH值为4.6,温度为35℃,摇床转速为150转/分钟,培养时间为2天,培养基由重量份数为3的三聚磷酸钠、重量份数为5的糖蜜、重量份数为2的啤酒酵母菌和重量份数为3的鼠李糖乳杆菌组成;
g.将步骤f制得的培养液浓缩,放置于烘箱内,在45℃条件下烘干,即得组合物。
实施例4
一种组合物,该组合物由下列重量份的成分组成:
该组合物的制备方法为:
a.按照重量份数称取半夏放置于锅内,将0.6倍重量的生姜捣烂,加入与生姜同重量比例的水形成姜汁,将姜汁覆盖于半夏的表面,160℃条件下炒制1.3h,取出放凉,室温下阴干,得半夏姜制品;
b.按照重量份数称取枳实和元胡放置于高压锅内,将枳实和元胡浸泡在0.8倍重量的醋中,浸泡时间为1.5h,浸泡完毕后,将枳实和元胡在100℃条件下焖制4h,炒干,即得混合醋制品;
c.按照重量份数称取水蛭,称取0.5倍重量的滑石粉放置于锅内,在225℃条件下翻炒10min,再将水蛭倒入锅内,与滑石粉一起翻炒0.5-1h,阴干,得水蛭炮制品;
d.按照重量份数称取当归放置于砂锅内,在砂锅内加入0.5倍量的黄酒浸泡1.5h,将砂锅转移至蒸锅内,在180℃条件下蒸制1h,阴干,即得当归酒制品;
e.将步骤a、b、c、d制得的药物与剩余重量份的药物混匀后粉碎,过100目筛,即得组合物。
实施例5
一种组合物,该组合物由下列重量份的成分组成:
该组合物的制备方法为:
a.按照重量份数称取半夏放置于锅内,将0.6倍重量的生姜捣烂,加入与生姜同重量比例的水形成姜汁,将姜汁覆盖于半夏的表面,120℃条件下炒制1.3h,取出放凉,室温下阴干,得半夏姜制品;
b.按照重量份数称取枳实和元胡放置于高压锅内,将枳实和元胡浸泡在0.8倍重量的醋中,浸泡时间为1.5h,浸泡完毕后,将枳实和元胡在100℃条件下焖制4h,炒干,即得混合醋制品;
c.按照重量份数称取水蛭,称取0.5倍重量的滑石粉放置于锅内,在225℃条件下翻炒10min,再将水蛭倒入锅内,与滑石粉一起翻炒1h,阴干,得水蛭炮制品;
d.按照重量份数称取当归放置于砂锅内,在砂锅内加入0.5倍量的黄酒浸泡1h,将砂锅转移至蒸锅内,在200℃条件下蒸制1h,阴干,即得当归酒制品;
e.按照重量份数称取步骤a-d制得的半夏姜制品、混合醋制品、水蛭炮制品、当归酒制品和剩余原料药,混匀后放置于中药提取罐中,在100℃条件下提取3次,每次30min,得水提取液;
f.将步骤e制得的水提取液接种于益生菌培养基中进行培养,过滤,得培养液,培养条件为:起始pH值为4.6,温度为35℃,摇床转速为150转/分钟,培养时间为2天,培养基由重量份数为3的三聚磷酸钠、重量份数为5的糖蜜、重量份数为2的啤酒酵母菌和重量份数为3的鼠李糖乳杆菌组成;
g.将步骤f制得的培养液浓缩,放置于烘箱内,在45℃条件下烘干,即得组合物。
实施例6
一种组合物,与实施例1的不同之处在于,增加了如下重量份的成分:
该组合物的制备方法为:
a.按照重量份数称取半夏放置于锅内,将0.8倍重量的生姜捣烂,加入与生姜同重量比例的水形成姜汁,将姜汁覆盖于半夏的表面,200℃条件下炒制1.5h,取出放凉,室温下阴干,得半夏姜制品;
b.按照重量份数称取枳实和元胡放置于高压锅内,将枳实和元胡浸泡在1倍重量的醋中,浸泡时间为2h,浸泡完毕后,将枳实和元胡在250℃条件下焖制5h,炒干,即得混合醋制品;
c.按照重量份数称取水蛭,称取0.5倍重量的滑石粉放置于锅内,在250℃条件下翻炒10min,再将水蛭倒入锅内,与滑石粉一起翻炒1h,阴干,得水蛭炮制品;
d.按照重量份数称取当归放置于砂锅内,在砂锅内加入0.5倍量的黄酒浸泡2h,将砂锅转移至蒸锅内,在200℃条件下蒸制1h,阴干,即得当归酒制品;
e.将步骤a、b、c、d制得的药物与剩余重量份的药物混匀后粉碎,过100目筛,即得组合物。
实施例7水丸
水丸由如下重量份的成分组成:
实施例8水丸
水丸由以下重量份的成分组成:
实施例9水丸
水丸由以下重量份的成分组成:
对照例1
一种组合物,与实施例1的区别之处在于,增加了重量份数为50的川贝母。
对照例2
一种组合物,与实施例1的区别之处在于,用元胡替代了延胡索。对照例3
一种组合物,与实施例1的区别之处在于,删除了枳实。
对照例4
一种组合物,与实施例2的区别之处在于,增加了重量份数为50的车前子。
对照例5
一种组合物,与实施例2的区别之处在于,用知母替代了常山。对照例6
一种组合物,与实施例2的区别之处在于,删除了萹蓄。
对照例7水丸
一种水丸,与实施例8的区别之处在于,增加了1份的磷酸钙。对照例8水丸
一种水丸,与实施例8的区别之处在于,用淀粉胶替代了无水乳糖。
对照例9水丸
一种水丸,与实施例8的区别之处在于,删除了微晶纤维素。
试验例1对冠心病、心绞痛的治疗效果
1.试验人群
选择200例冠心病心绞痛患者,其中男66例,女59例,年龄为40-65岁,病程为0.5-3年。
2.诊断标准
1)膻中或心前区憋闷疼痛,甚则痛彻左肩背、咽喉、胃脘部、左上臂内侧等部位,呈反复发作性或持续不解,常伴有心悸、气短、自汗、甚则喘息不得卧;
2)胸闷胸痛一般几秒到几十分钟可缓解,严重者可见疼痛剧烈,持续不解,汗出肢冷,面色苍白,唇甲青紫,心跳加快或心律失常等危候,可发生猝死;
3)多见于中年以上,常因操劳过度、抑郁恼怒或多饮暴食、感受寒冷而诱发;
4)心电图检查有缺血性改变或运动试验阳性。
3.分组
将200例冠心病心绞痛受试者随机分成试验1组25人、试验2组25人、试验3组25人、试验4组25人、对照1组25人、对照2组25人、对照3组25人、对照4组25人;试验1组使用本发明实施例1的组合物;试验2组使用本发明实施例2的组合物;试验3组使用本发明实施例3的组合物;试验4组使用本发明实施例4的组合物;对照1组使用对照例1的组合物;对照2组使用对照例2的组合物;对照3组使用对照例3的组合物;对照4组使用CN103784820B公开的药物,其中,水丸的用法用量为:每次5克,一日1-3次,早、午饭前,晚上睡觉前1小时各服一次;此外,还可在发作时或不适时随时加服,水丸的直径为2mm。
4.疗效评定标准
痊愈:心绞痛、胸闷、憋闷等症状全部消失,生活和工作全部正常;
显效:心绞痛、胸闷、憋闷等症状消失80%,生活和工作基本恢复正常;
有效:心绞痛发作次数减少,疼痛减轻,胸闷憋气症状有所减轻;
无效:心绞痛症状无改善,胸闷憋气仍严重,不能正常生活和工作。
5.结果
8组受试者均治疗4各疗程,7天为1个疗程,8组组合物对冠心病心绞痛的治疗结果见表1;
表1各组合物对患者冠心病、心绞痛的治疗结果
由表1可以看出,试验1-4组的组合物对对冠心病、心绞痛患者的治愈率明显高于对照1-4组,证明本发明提供的组合物有很好的治疗冠心病、心绞痛的效果,当本发明提供的组合物中的原料药减少或者被替换成别的原料药后,该组合物对冠心病、心绞痛的治疗效果显著降低,实施例2对冠心病、心绞痛的治疗效果好于实施例1,说明在组合物中加入萹蓄和常山后,提高了组合物治疗冠心病和心绞痛的效果,且实施例3的组合物对冠心病、心绞痛的治疗效果明显高于实施例1-2和实施例4的组合物,证明本发明提供的制备方法能显著的提高组合物中有效成分的含量,本发明提供的组合物对冠心病、心绞痛具有很好的治疗效果。
试验例2鼻炎的治疗效果
1鼻炎动物模型:
将小鼠随机分为8组,每组10只,分别为模型组、对照组和试验1-6组,其中,试验1-6组分别灌胃实施例2、实施例5-6和对照例4-6的水丸。
模型组:将20μg卵蛋白和2mg氢氧化铝加入0.5mLNaCl(0.9%)混悬,于造模第1、2、5、8天于小鼠体内腹腔注射混悬液0.5mL,于造模后第15-24天用20μlNaCl(0.9%)连续滴鼻。
对照组:正常饲养小鼠,于造模第15-24天用20μlNaCl(0.9%)连续滴鼻。
试验组:设置实施例2、实施例5-6和对照例4-6的水丸作为试验1-6组,于造模第1、2、5、8天于小鼠体内腹腔注射混悬液0.5mL,于造模后第15-24天用试验1-6组的水丸给小鼠灌胃,给药量为0.5mg/天/只。
2小鼠行为学评分标准:
喷嚏计数:0个为0分,1-3个为1分,4-8个为2分,8个以上为3分;
鼻涕长度:不流鼻涕为0分,鼻涕流至鼻孔为1分,流出鼻孔为2分,滞留满面为3分;
骚鼻次数:0次为0分,1-3次为1分,3次以上为2分;
每组5只小鼠,取评分的平均值;30分钟内进行计数,量化叠加评分。
3结果
以上实验组均给药到造模后第24天,试验结果如表2所示。
表2水丸对小鼠行为学评分的影响
三.结论
由表2可知,本发明实施例2、实施例5-6提供的对小鼠的鼻炎具有显著的治疗效果好于对照例4-6的组合物,表明本发明提供的组合物对鼻炎具有很好的疗效,当本发明提供的组合物中的原料药减少或者被替换成别的原料药后,该组合物对鼻炎的治疗效果显著降低,并且实施例5的组合物对鼻炎的治疗效果高于实施例2和实施例6的组合物,证明本发明提供的提取方法能够显著提高有效成分的含量,进而提高药效。
试验例3吸湿性试验
分别取以上实施例7-9、对照例7-9,放置于干燥器内自然冷却,将干燥后的样品放置于干燥后的带盖称量杯内,记录称量杯和样品的重量,将盛有干燥样品的称量杯放置于保湿器中,打开盖子,记录起始日期、时刻及气象条件,同时将相对湿度计放置于保湿器中,对应室温经常记录相对湿度值及观测时间,将保湿器中的样杯在24h后闭盖,逐个取出称重记录,结果见表3。
表3各组水丸的吸湿率试验结果
从表3中可以看出实施例7-9的水丸在24h内吸湿率较低,而对照例7-9的水丸在24h内吸湿率较高。由此可以得出,在水丸中加入无水乳糖、磷酸二氢钙和微晶纤维素的混合物能够降低吸湿率,起到防潮的效果。
Claims (9)
1.一种用于治疗冠心病、心绞痛的组合物,其特征在于,所述组合物由下列重量份的原料制备而成:
2.如权利要求1所述的用于治疗冠心病、心绞痛的组合物,其特征在于,所述组合物由下列重量份的原料制备而成:
3.如权利要求1所述的用于治疗冠心病、心绞痛的组合物,其特征在于,所述组合物还包括如下重量份的原料:
萹蓄 50-100 常山 50-100。
4.如权利要求3所述的用于治疗冠心病、心绞痛的组合物,其特征在于,所述组合物由下列重量份的原料制备而成:
5.如权利要求1所述的用于治疗冠心病、心绞痛的组合物,其特征在于,所述组合物由如下方法制备而成:
1)将半夏用姜汁炒制阴干,将枳实、元胡醋制后炒干,将水蛭用滑石粉炒制,将当归酒制后阴干;
2)将步骤1)的药物与剩余重量份的药物混匀后粉碎,过100目筛,即得所述组合物。
6.一种如权利要求1所述的用于治疗冠心病、心绞痛组合物的制备方法,其特征在于,所述方法包括如下步骤:
a.按照重量份数称取半夏放置于锅内,将0.5-0.8倍重量的生姜捣烂,加入与生姜同重量比例的水形成姜汁,将姜汁覆盖于半夏的表面,120-200℃条件下炒制1-1.5h,取出放凉,室温下阴干,得半夏姜制品;
b.按照重量份数称取枳实和元胡放置于高压锅内,将枳实和元胡浸泡在0.5-1倍重量的醋中,浸泡时间为1-2h,浸泡完毕后,将枳实和元胡在150-250℃条件下焖制3-5h,炒干,即得混合醋制品;
c.按照重量份数称取水蛭,称取0.5倍重量的滑石粉放置于锅内,在200-250℃条件下翻炒10min,再将水蛭倒入锅内,与滑石粉一起翻炒0.5-1h,得水蛭炮制品;
d.按照重量份数称取当归放置于砂锅内,在砂锅内加入0.5倍量的黄酒浸泡1-2h,将砂锅转移至蒸锅内,在150-200℃条件下蒸制1h,阴干,即得当归酒制品;
e.按照重量份数称取步骤a-d制得的半夏姜制品、混合醋制品、水蛭炮制品、当归酒制品和剩余原料药,混匀后放置于中药提取罐中,在100℃条件下提取3次,每次30min,得水提取液;
f.将步骤e制得的水提取液接种于益生菌培养基中进行培养,过滤,得培养液,培养条件为:起始pH值为4.6,温度为35℃,摇床转速为150转/分钟,培养时间为2天,培养基由重量份数为3的三聚磷酸钠、重量份数为5的糖蜜、重量份数为2的啤酒酵母菌和重量份数为3的鼠李糖乳杆菌组成;
g.将步骤f制得的培养液浓缩,放置于烘箱内,在45℃条件下烘干,即得所述组合物。
7.一种水丸,包括权利要求1-4任一所述的用于治疗冠心病、心绞痛的组合物、辅料和蒸馏水,所述组合物、辅料和蒸馏水的重量份数比为100:2-5:25。
8.如权利要求7所述的水丸,其特征在于,所述辅料包括重量份数为1-3的无水乳糖、0.5-1的磷酸二氢钙和0.5-1的微晶纤维素。
9.权利要求1-4任一项所述的组合物在制备用于治疗或辅助治疗冠心病、心绞痛的产品中的应用。
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