CN106563098A - 一种治疗心律失常的药物组合物 - Google Patents
一种治疗心律失常的药物组合物 Download PDFInfo
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- CN106563098A CN106563098A CN201610812294.7A CN201610812294A CN106563098A CN 106563098 A CN106563098 A CN 106563098A CN 201610812294 A CN201610812294 A CN 201610812294A CN 106563098 A CN106563098 A CN 106563098A
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Abstract
本发明涉及一种治疗心律失常的药物组合物及其制备方法,该药物组合物由以下重量份的药物制成:布渣叶、土茯苓、山柰、百部、橘核、川芎、希莶草、广升麻、石榴子、芫荽果、北豆根、红花,通过水煎煮、浸泡工艺制成,通过药效学试验显示本发明能明显降低氯仿所诱发小鼠室颤的发生,延长小鼠死亡时间;能减少氯化钡致大鼠室性心律失常的发生率;能明显减轻异搏定所致小鼠心动过缓的程度,证明本发明具有治疗心律失常的功能,且安全无毒副作用。
Description
技术领域
本发明涉及医药发明领域,具体涉及一种治疗心律失常的药物组合物及其制备方法。
背景技术
心脏正常激动起源于窦房结,沿着传导系统下传,在一定时间范围内依次抵达心房和心室,使心脏收缩和舒张。如果窦房结激动异常或激动产生于窦房结以外,激动的传导缓慢、阻滞或经异常通道传导,就会出现心律失常。因此,心律失常是由于心脏活动的起源和(或)传导障碍导致心脏搏动的频率和(或)节律异常。常见类型有早搏、心房颤动、房室传导阻滞、交界性心律、窦性心动过缓、窦性心动过速等,临床表现为心慌、胸闷、憋喘、头晕、脉律过快、过缓或不齐等。心律失常在中年人群中的发病率是非常高的。心律失常是心血管疾病中重要的一组疾病。它可单独发病亦可与心血管病伴发。由于其发病可突然发作而致猝死,亦可持续累及心脏而衰竭,故掌握其发生、发展规律及其防治措施实为重要。
目前,采用西药治疗心律失常主要是控制发作、减少危害、预防再发或控制心室率为治疗原则,治疗心律失常的药物主要有钠通道阻滞药、β受体阻滞药、钙通道阻滞药、延长动作电位时程药四种,但是所有抗心律失常药物均有致心律失常作用,其发生率为6~36%,其机制与心电冲动形成或传导障碍有关,因此,抗心律失常西药存在的一定用药安全问题。根据中医理论,针对心律失常的发病机理,研发一种标本兼治的中药是众研发者努力的方向。
本发明人为了解决上述问题,研发了一种新药。
发明内容
本发明的目的是提供一种治疗心律失常的药物组合物。
本发明的另一目的是提供一种治疗心律失常的药物组合物的制备方法。
本发明提供一种治疗心律失常的药物组合物,该药物组合物由以下重量份的药物制成:布渣叶10-40份、土茯苓10-40份、山柰5-35份、百部10-40份、橘核20-60份、川芎10-40份、希莶草5-30份、广升麻10-40份、石榴子15-55份、芫荽果10-35份、北豆根5-20份、红花10-40份。
优选的,本发明所述的药物组合物由以下重量份的药物制成:布渣叶13-37份、土茯苓13-37份、山柰8-32份、百部13-37份、橘核25-55份、川芎13-37份、希莶草8-27份、广升麻13-37份、石榴子20-50份、芫荽果13-32份、北豆根7-18份、红花13-37份。
进一步优选的,本发明所述的药物组合物由以下重量份的药物制成:布渣叶17-33份、土茯苓17-33份、山柰10-30份、百部17-33份、橘核30-50份、川芎17-33份、希莶草12-25份、广升麻17-33份、石榴子25-45份、芫荽果17-28份、北豆根9-16份、红花17-33份。
更进一步优选的,本发明所述的药物组合物由以下重量份的药物制成:布渣叶21-29份、土茯苓20-30份、山柰15-25份、百部20-30份、橘核35-45份、川芎20-30份、希莶草15-22份、广升麻20-30份、石榴子30-40份、芫荽果20-27份、北豆根11-14份、红花20-30份。
更进一步优选的,本发明所述的药物组合物由以下重量份的药物制成:布渣叶25份、土茯苓25份、山柰20份、百部25份、橘核40份、川芎25份、希莶草18份、广升麻25份、石榴子35份、芫荽果24份、北豆根12份、红花25份。
本发明所述的药物组合物还含有药学上可接受的载体或稀释剂。
本发明所述的药物组合物为固体制剂或液体制剂,所述固体制剂为片剂、胶囊剂、颗粒剂或丸剂;所述液体制剂为口服液。
本发明所述的药物组合物制备方法包括以下步骤:将布渣叶、土茯苓、山柰、百部、橘核、川芎、希莶草、广升麻、石榴子、芫荽果、北豆根、红花粉碎过筛,与药学上可接受的载体或稀释剂混合均匀,制备成制剂。
本发明所述的药物组合物制备方法包括以下步骤:
1)称取重量份药物;
2)将北豆根用文火炒8-15分钟,加3-6倍量水煎煮10-16分钟,过滤,滤液浓缩干燥,粉碎成细粉备用;
3)将橘核打碎,用52度白酒浸泡12-16分钟,过滤,滤液浓缩干燥,粉碎成细粉备用;
4)将红花粉碎成细粉,备用;
5)将布渣叶、土茯苓、山柰、百部、川芎、希莶草、广升麻、石榴子、芫荽果加4-9倍量水煎煮2-4次,每次1-3小时,合并煎液,滤过,滤液浓缩干燥,粉碎成细粉,备用;
6)将步骤2)、3)、4)、5)备用的细粉混合均匀,加入药学上可接受的载体或稀释剂混合均匀,制成制剂。
优选的,本发明所述的药物组合物制备方法包括以下步骤:
1)称取重量份药物;
2)将北豆根用文火炒12分钟,加5倍量水煎煮13分钟,过滤,滤液浓缩干燥,粉碎成细粉备用;
3)将橘核打碎,用52度白酒浸泡14分钟,过滤,滤液浓缩干燥,粉碎成细粉备用;
4)将红花粉碎成细粉,备用;
5)将布渣叶、土茯苓、山柰、百部、川芎、希莶草、广升麻、石榴子、芫荽果加6倍量水煎煮3次,每次2小时,合并煎液,滤过,滤液浓缩干燥,粉碎成细粉,备用;
6)将步骤2)、3)、4)、5)备用的细粉混合均匀,加入药学上可接受的载体或稀释剂混合均匀,制成制剂。
所述重量份数可以是μg、mg、g、kg等医药领域公知的重量单位。
倍量的含义是指药材的重量比。
所述药学上可接受的载体或稀释剂是指药学领域常规的药物载体,选自填充剂、粘合剂、崩解剂、润滑剂、表面活性剂或矫味剂中的一种或几种。
其中所述填充剂选自淀粉、蔗糖、乳糖、甘露醇、山梨醇、木糖醇、微晶纤维素或葡萄糖等;
所述粘合剂选自纤维素衍生物、藻酸盐、明胶或聚乙烯吡咯烷酮等;
所述崩解剂选自微晶纤维素、羧甲基淀粉钠、聚乙烯吡咯烷酮、低取代羟丙基纤维素或交联羧甲基纤维素钠;
所述润滑剂选自硬脂酸、聚乙二醇、碳酸钙、碳酸氢钠、二氧化硅、滑石粉或硬脂酸镁;
所述表面活性剂选自十二烷基苯磺酸钠、硬脂酸、聚氧乙烯-聚氧丙烯共聚物、脂肪酸山梨坦或聚山梨酯(吐温)等;
所述矫味剂选自阿斯巴甜、蔗糖素或糖精钠。
本发明提供的治疗心律失常的药物组合物具有以下优点:
通过药效学试验显示本发明能明显降低氯仿所诱发小鼠室颤的发生,延长小鼠死亡时间;能减少氯化钡致大鼠室性心律失常的发生率;能明显减轻异搏定所致小鼠心动过缓的程度,证明本发明具有治疗心律失常的功能,且安全无毒副作用。
具体实施方式
以下实施例用于说明本发明,但不用来限制本发明的范围。
实施例1
组方:布渣叶10g、土茯苓10g、山柰5g、百部10g、橘核20g、川芎10g、希莶草5g、广升麻10g、石榴子15g、芫荽果10g、北豆根5g、红花10g。
制备方法:
1)称取重量份药物;
2)将北豆根用文火炒8分钟,加3倍量水煎煮10分钟,过滤,滤液浓缩干燥,粉碎成细粉备用;
3)将橘核打碎,用52度白酒浸泡12分钟,过滤,滤液浓缩干燥,粉碎成细粉备用;
4)将红花粉碎成细粉,备用;
5)将布渣叶、土茯苓、山柰、百部、川芎、希莶草、广升麻、石榴子、芫荽果加4倍量水煎煮2次,每次1小时,合并煎液,滤过,滤液浓缩干燥,粉碎成细粉,备用;
6)将步骤2)、3)、4)、5)备用的细粉混合均匀,加入占混合均匀细粉重量1/5的淀粉,装入胶囊,制成胶囊剂。
实施例2
组方:布渣叶40g、土茯苓40g、山柰35g、百部40g、橘核60g、川芎40g、希莶草30g、广升麻40g、石榴子55g、芫荽果35g、北豆根20g、红花40g。
制备方法:
1)称取重量份药物;
2)将北豆根用文火炒15分钟,加6倍量水煎煮16分钟,过滤,滤液浓缩干燥,粉碎成细粉备用;
3)将橘核打碎,用52度白酒浸泡16分钟,过滤,滤液浓缩干燥,粉碎成细粉备用;
4)将红花粉碎成细粉,备用;
5)将布渣叶、土茯苓、山柰、百部、川芎、希莶草、广升麻、石榴子、芫荽果加9倍量水煎煮4次,每次3小时,合并煎液,滤过,滤液浓缩干燥,粉碎成细粉,备用;
6)将步骤2)、3)、4)、5)备用的细粉混合均匀,加入占混合均匀细粉重量1/5的淀粉,混匀,制粒,干燥,整粒,得到本申请的颗粒剂。
实施例3
组方:布渣叶13g、土茯苓13g、山柰8g、百部13g、橘核25g、川芎13g、希莶草8g、广升麻13g、石榴子20g、芫荽果13g、北豆根7g、红花13g。
制备方法:
1)称取重量份药物;
2)将北豆根用文火炒9分钟,加4倍量水煎煮11分钟,过滤,滤液浓缩干燥,粉碎成细粉备用;
3)将橘核打碎,用52度白酒浸泡13分钟,过滤,滤液浓缩干燥,粉碎成细粉备用;
4)将红花粉碎成细粉,备用;
5)将布渣叶、土茯苓、山柰、百部、川芎、希莶草、广升麻、石榴子、芫荽果加5倍量水煎煮3次,每次2小时,合并煎液,滤过,滤液浓缩干燥,粉碎成细粉,备用;
6)将步骤2)、3)、4)、5)备用的细粉混合均匀,加入占混合均匀细粉重量1/5的淀粉,装入胶囊,制成胶囊剂。
实施例4
组方:布渣叶37g、土茯苓37g、山柰32g、百部37g、橘核55g、川芎37g、希莶草27g、广升麻37g、石榴子50g、芫荽果32g、北豆根18g、红花37g。
制备方法:
1)称取重量份药物;
2)将北豆根用文火炒14分钟,加5倍量水煎煮14分钟,过滤,滤液浓缩干燥,粉碎成细粉备用;
3)将橘核打碎,用52度白酒浸泡14分钟,过滤,滤液浓缩干燥,粉碎成细粉备用;
4)将红花粉碎成细粉,备用;
5)将布渣叶、土茯苓、山柰、百部、川芎、希莶草、广升麻、石榴子、芫荽果加8倍量水煎煮3次,每次2小时,合并煎液,滤过,滤液浓缩干燥,粉碎成细粉,备用;
6)将步骤2)、3)、4)、5)备用的细粉混合均匀,加入占混合均匀细粉重量1/5的淀粉,干燥,压片,即得本申请的片剂。
实施例5
组方:布渣叶17g、土茯苓17g、山柰10g、百部17g、橘核30g、川芎17g、希莶草12g、广升麻17g、石榴子25g、芫荽果17g、北豆根9g、红花17g。
制备方法:
1)称取重量份药物;
2)将北豆根用文火炒12分钟,加5倍量水煎煮13分钟,过滤,滤液浓缩干燥,粉碎成细粉备用;
3)将橘核打碎,用52度白酒浸泡14分钟,过滤,滤液浓缩干燥,粉碎成细粉备用;
4)将红花粉碎成细粉,备用;
5)将布渣叶、土茯苓、山柰、百部、川芎、希莶草、广升麻、石榴子、芫荽果加6倍量水煎煮3次,每次2小时,合并煎液,滤过,滤液浓缩干燥,粉碎成细粉,备用;
6)将步骤2)、3)、4)、5)备用的细粉混合均匀,加入占混合均匀细粉重量1/5的淀粉,装入胶囊,制成胶囊剂。
实施例6
组方:布渣叶33g、土茯苓33g、山柰30g、百部33g、橘核50g、川芎33g、希莶草25g、广升麻33g、石榴子45g、芫荽果28g、北豆根16g、红花33g。
制备方法:
1)称取重量份药物;
2)将北豆根用文火炒12分钟,加5倍量水煎煮13分钟,过滤,滤液浓缩干燥,粉碎成细粉备用;
3)将橘核打碎,用52度白酒浸泡14分钟,过滤,滤液浓缩干燥,粉碎成细粉备用;
4)将红花粉碎成细粉,备用;
5)将布渣叶、土茯苓、山柰、百部、川芎、希莶草、广升麻、石榴子、芫荽果加6倍量水煎煮3次,每次2小时,合并煎液,滤过,滤液浓缩干燥,粉碎成细粉,备用;
6)将步骤2)、3)、4)、5)备用的细粉混合均匀,加入占混合均匀细粉重量1/5的淀粉,装入胶囊,制成胶囊剂。
实施例7
组方:布渣叶21g、土茯苓20g、山柰15g、百部20g、橘核35g、川芎20g、希莶草15g、广升麻20g、石榴子30g、芫荽果20g、北豆根11g、红花20g。
制备方法:
1)称取重量份药物;
2)将北豆根用文火炒12分钟,加5倍量水煎煮13分钟,过滤,滤液浓缩干燥,粉碎成细粉备用;
3)将橘核打碎,用52度白酒浸泡14分钟,过滤,滤液浓缩干燥,粉碎成细粉备用;
4)将红花粉碎成细粉,备用;
5)将布渣叶、土茯苓、山柰、百部、川芎、希莶草、广升麻、石榴子、芫荽果加6倍量水煎煮3次,每次2小时,合并煎液,滤过,滤液浓缩干燥,粉碎成细粉,备用;
6)将步骤2)、3)、4)、5)备用的细粉混合均匀,加入占混合均匀细粉重量1/5的淀粉,装入胶囊,制成胶囊剂。
实施例8
组方:布渣叶29g、土茯苓30g、山柰25g、百部30g、橘核45g、川芎30g、希莶草22g、广升麻30g、石榴子40g、芫荽果27g、北豆根14g、红花30g。
制备方法:
1)称取重量份药物;
2)将北豆根用文火炒12分钟,加5倍量水煎煮13分钟,过滤,滤液浓缩干燥,粉碎成细粉备用;
3)将橘核打碎,用52度白酒浸泡14分钟,过滤,滤液浓缩干燥,粉碎成细粉备用;
4)将红花粉碎成细粉,备用;
5)将布渣叶、土茯苓、山柰、百部、川芎、希莶草、广升麻、石榴子、芫荽果加6倍量水煎煮3次,每次2小时,合并煎液,滤过,滤液浓缩干燥,粉碎成细粉,备用;
6)将步骤2)、3)、4)、5)备用的细粉混合均匀,加入占混合均匀细粉重量1/5的淀粉,装入胶囊,制成胶囊剂。
实施例9
组方:布渣叶25g、土茯苓25g、山柰20g、百部25g、橘核40g、川芎25g、希莶草18g、广升麻25g、石榴子35g、芫荽果24g、北豆根12g、红花25g。
制备方法:
1)称取重量份药物;
2)将北豆根用文火炒12分钟,加5倍量水煎煮13分钟,过滤,滤液浓缩干燥,粉碎成细粉备用;
3)将橘核打碎,用52度白酒浸泡14分钟,过滤,滤液浓缩干燥,粉碎成细粉备用;
4)将红花粉碎成细粉,备用;
5)将布渣叶、土茯苓、山柰、百部、川芎、希莶草、广升麻、石榴子、芫荽果加6倍量水煎煮3次,每次2小时,合并煎液,滤过,滤液浓缩干燥,粉碎成细粉,备用;
6)将步骤2)、3)、4)、5)备用的细粉混合均匀,加入占混合均匀细粉重量1/5的淀粉,装入胶囊,制成胶囊剂。
以下内容为对上述实施例提供的治疗心律失常的药物组合物进行的药效和毒理试验研究:
1、目的
观察本发明组合物对氯仿诱发小鼠心室纤颤的影响,对氯化钡致大鼠心律失常的影响,对异搏定致小鼠心律失常的影响,以期全面客观评价其药效,为进一步临床研究提供实验依据。
2、实验材料:
2.1实验动物:昆明种小鼠,体重20-25g;Wistcr大鼠,体重200-220g。
2.2实验药物:本发明药物组合物,参松养心胶囊。
2.3试剂:氯仿、氯化钡、异搏定、戊巴比妥纳。
2.4仪器:恒速微量泵、BL-420型4道生理记录仪。
3、方法与结果:
3.1本发明药物组合物对氯仿诱发小鼠心室纤颤的影响
将昆明种小鼠按体重随机分为5组,每组10只,空白对照组给予生理盐水;阳性对照组给予参松养心胶囊(8g/kg):本发明药物组合物高剂量组(8g/kg);本发明药物组合物中剂量组(4/kg);本发明药物组合物低剂量组(2g/kg),20ml/kg,灌胃给药,每天一次,连续7天,末次给药60分钟后,将小鼠逐一放入预先置有氯仿棉球的400ml烧杯内。氯仿用法:第一次2ml,后每次补加0.5ml,待小鼠呼吸停止后,迅速取出开胸观察心脏活动节律,记录各组发生室颤的动物数及死亡时间。实验数据采用组间t检验的方法进行统计,结果见表1。
表1本发明药物组合物对氯仿致小鼠心室颤动的影响
注:与空白对照组比较p<0.01,与参松养心胶囊比较p>0.05。
由上表1可以看出,本发明组合物高、中、低剂量组和参松养心胶囊对氯仿诱发的小鼠室颤都有保护作用,能明显降低氯仿所诱发小鼠室颤的发生,延长小鼠死亡时间,与空白对照组相比,本发明组合物高、中、低剂量组均有显著性差异,与参松养心胶囊组相比无显著差异。
3.2本发明药物组合物对氯化钡致大鼠心律失常的影响得
将wister大鼠体重随机均分为5组,每组10只,空白对照组给予生理盐水,阳性对照组给予参松养心胶囊(8g/kg),本发明药物组合物高剂量 组(8g/kg),中剂量组(4g/kg),低剂量(2g/kg),灌胃给药,20ml/kg,每天一次,连续7天,末次给药60min后,将大鼠用戊巴比妥纳腹腔注射麻醉(1.3g/kg),仰卧位固定鼠置台上,记录II导联ECG,舌下静脉快速注射0.4%氯化钡(4mg/kg>,诱发室性心律失常,以静脉注射扎氯化钡后30min内不出现室性心律失常为指标,用x2检验.比较组间差异的显著性,结果见表2。
表2本发明药物组合物对氯化钡性大鼠心律失常的影响
注:**与空白对照组比较P<0.05。
结论:空白对照组注射氯化钡后,均出现不同程度室性心律失常,包括室性早搏和室性心动过速,30min内无复律发生,本发明药物组合物高、中、低剂量组和参松养心胶囊组均能明抑制氯化钡致心律失常的发生,与空白对照组比较,有显著的差弄(P<0.05>*。
3.3本发明实施例1对异搏定致小鼠心律失常的影响
本实验采用异搏定诱发小鼠心动过缓模型造型法,将昆明种小鼠按体重随机分为5组,每组10只,空白对照组给予生理盐水,阳性对照组给予参松养心胶囊(8g/kg),本发明药物组合物高剂量组(8g/kg),中剂量组(4/kg),低剂量组(2g/kg),20ml/kg,灌胃给药,每天一次,连续7天,末次给药60min后,将小鼠用戊巴比妥钠腹腔注射麻醉(1.3g/kg),仰卧位固定于鼠台上,记录正常ECG,然后经小鼠尾静脉注射8mg/kg的异搏定, 分别记录注射前、注射即刻、注射后30min的心电图变化。计算注射药物前后心律减慢的百分率.计算公式为:(注射药物后心率一注射药物前心率)/注射药物前心率*100%,实验数据采用组间t检验的方法进行统计,结果见表3。
表3本发明组合物对异搏定致小鼠心律失常的影响
注:与注射前比较p<0.01,与**空白对照组比较p<0.01。
实验结果表明.本发明药物组合物对异搏定诱发小鼠心动过缓性心率失常有明显的拮抗作用,能明显减轻小鼠心动过缓的程度,本发明药物组合物高、中、低剂量组心率变化率均小于对照组,与空白对照组比较,有显著性差异(p<0.01)
结果:本发明能明显降低氯仿所诱发小鼠室颤的发生,延长小鼠死亡时间;能减少氯化钡致大鼠室性心律失常的发生率;能明显减轻异搏定所致小鼠心动过缓的程度。
4、安全性分析及评价
取小鼠20只,雌雄各半,体重20-22g,实验前禁食(不禁水)12h,每鼠按最大给药体积(0.4ml/10g)灌服最大可灌胃浓度(0.6g/ml)的本发明的浓缩液,并于一日之内连续3次,每次间隔8h,连续观察7天,未见动物发生死亡,小鼠初次灌胃后见动物活动减少,呈镇静状,一般3-4h后活动 渐恢复,第7天小鼠称重后处死,解剖,未有肉眼可见有明显肝、心、脾、肺、肾的异常,小鼠开始体重为20.0±0.8g,第7天体重为22.3±1.6g。其每日累积最大耐受量为69g/kg,该量已大大超过临床用量,可以认为临床应用完全无毒。
综上所述,通过药效学试验显示本发明能明显降低氯仿所诱发小鼠室颤的发生,延长小鼠死亡时间;能减少氯化钡致大鼠室性心律失常的发生率;能明显减轻异搏定所致小鼠心动过缓的程度,证明本发明具有治疗心律失常的功能,且安全无毒副作用。
虽然,上文中已经用一般性说明、具体实施方式及试验,对本发明作了详尽的描述,但在本发明基础上,可以对之作出一些修改或改进,这对本领域技术人员而言是显而易见的。因此,在不偏离本发明精神的基础上所做的这些修改或改进,均属于本发明要求保护的范围。
Claims (10)
1.一种治疗心律失常的药物组合物,其特征在于该药物组合物由以下重量份的药物制成:布渣叶10-40份、土茯苓10-40份、山柰5-35份、百部10-40份、橘核20-60份、川芎10-40份、希莶草5-30份、广升麻10-40份、石榴子15-55份、芫荽果10-35份、北豆根5-20份、红花10-40份。
2.根据权利要求1所述的药物组合物,其特征在于该药物组合物由以下重量份的药物制成:布渣叶13-37份、土茯苓13-37份、山柰8-32份、百部13-37份、橘核25-55份、川芎13-37份、希莶草8-27份、广升麻13-37份、石榴子20-50份、芫荽果13-32份、北豆根7-18份、红花13-37份。
3.根据权利要求2所述的药物组合物,其特征在于该药物组合物由以下重量份的药物制成:布渣叶17-33份、土茯苓17-33份、山柰10-30份、百部17-33份、橘核30-50份、川芎17-33份、希莶草12-25份、广升麻17-33份、石榴子25-45份、芫荽果17-28份、北豆根9-16份、红花17-33份。
4.根据权利要求3所述的药物组合物,其特征在于该药物组合物由以下重量份的药物制成:布渣叶21-29份、土茯苓20-30份、山柰15-25份、百部20-30份、橘核35-45份、川芎20-30份、希莶草15-22份、广升麻20-30份、石榴子30-40份、芫荽果20-27份、北豆根11-14份、红花20-30份。
5.根据权利要求4所述的药物组合物,其特征在于该药物组合物由以下重量份的药物制成:布渣叶25份、土茯苓25份、山柰20份、百部25份、橘核40份、川芎25份、希莶草18份、广升麻25份、石榴子35份、芫荽果24份、北豆根12份、红花25份。
6.根据权利要求1-5任一项所述的药物组合物,其特征在于,该药物组合物还含有药学上可接受的载体或稀释剂。
7.根据权利要求1-5任一项所述的药物组合物,其特征在于,所述药物组合物为固体制剂或液体制剂,所述固体制剂为片剂、胶囊剂、颗粒剂或丸剂;所述液体制剂为口服液。
8.一种制备权利要求1-5任一项所述的药物组合物的方法,其特征在于,该方法包括以下步骤:将布渣叶、土茯苓、山柰、百部、橘核、川芎、希莶草、广升麻、石榴子、芫荽果、北豆根、红花粉碎过筛,与药学上可接受的载体或稀释剂混合均匀,制备成制剂。
9.一种制备权利要求1-5任一项所述药物组合物的方法,其特征在于,该方法包括以下步骤:
1)称取重量份药物;
2)将北豆根用文火炒8-15分钟,加3-6倍量水煎煮10-16分钟,过滤,滤液浓缩干燥,粉碎成细粉备用;
3)将橘核打碎,用52度白酒浸泡12-16分钟,过滤,滤液浓缩干燥,粉碎成细粉备用;
4)将红花粉碎成细粉,备用;
5)将布渣叶、土茯苓、山柰、百部、川芎、希莶草、广升麻、石榴子、芫荽果加4-9倍量水煎煮2-4次,每次1-3小时,合并煎液,滤过,滤液浓缩干燥,粉碎成细粉,备用;
6)将步骤2)、3)、4)、5)备用的细粉混合均匀,加入药学上可接受的载体或稀释剂混合均匀,制成制剂。
10.根据权利要求9所述药物组合物的制备方法,其特征在于,该方法包括以下步骤:
1)称取重量份药物;
2)将北豆根用文火炒12分钟,加5倍量水煎煮13分钟,过滤,滤液浓缩干燥,粉碎成细粉备用;
3)将橘核打碎,用52度白酒浸泡14分钟,过滤,滤液浓缩干燥,粉碎成细粉备用;
4)将红花粉碎成细粉,备用;
5)将布渣叶、土茯苓、山柰、百部、川芎、希莶草、广升麻、石榴子、芫荽果加6倍水煎煮3次,每次2小时,合并煎液,滤过,滤液浓缩干燥,粉碎成细粉,备用;
6)将步骤2)、3)、4)、5)备用的细粉混合均匀,加入药学上可接受的载体或稀释剂混合均匀,制成制剂。
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