CN106491732A - 治疗神经性头痛的药物组合物及制备方法 - Google Patents
治疗神经性头痛的药物组合物及制备方法 Download PDFInfo
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Abstract
本发明涉及一种治疗神经性头痛的药物组合物,是由红参8~23、万年蒿17~33、大黄17~33、鸡血藤18~35、蚂蚁24~43、地龙28~43、松毛60~90按重量份经过水提取、浓缩、减压干燥、粉碎制丸而成。本发明药物组合物无毒副作用、易于吸收,总以健脾祛湿,理气活血止痛为主,兼以安神益智明目,具有治疗神经性头痛之功效。本发明还公开了一种治疗神经性头痛的药物组合物的制备方法。
Description
技术领域
本发明属于民族药朝药制剂领域,具体涉及一种治疗神经性头痛的药物组合物及制备方法。
背景技术
随着科技的进步,生产方式的转变,人们已经踏入科技时代,使人们从体力劳动更多的转向脑力劳动。然而,随着生活节奏的加快和工作压力的增加,神经活动过度紧张与疲劳等原因,引起神经性头痛病患者越来越多。神经性头痛主要是指紧张性头痛、功能性头痛及血管神经性头痛,多由精神紧张、激动、焦虑等因素引起,主要症状为持续性的头部胀痛,压迫感,沉重感或“紧箍感”。该病的特点表现为反复发作、迁延难愈, 是严重影响身心健康和生活质量的一种慢性疾病。神经性头痛发病机理:①环境因素:头痛是由于受到刺激、牵拉或压迫所致;②疾病因素:高血压及其他内脏疾病都可引起头痛;③生活因素:神经性头痛源于头部肌肉紧张收缩,因生活不规律、烟酒无度、睡眠不足等可引起头痛; ④职业因素:神经衰弱性头痛多见于脑力劳动者,往往因废寝忘食夜以继日地工作,缺乏锻炼、营养不足、过度疲劳等引起。神经性头痛源于头部肌肉紧张收缩,头部呈紧束或压迫样,有沉重感,常为跳扯痛,吸烟饮酒过度时会加剧。这多是因生活不规律、烟酒无度、睡眠不足引起。更年期性头痛由于内分泌的改变,人的生理功能受到影响,常有性格的改变,患者表现为急躁易怒、乏力懒言、头脑紧张、性欲淡等。]神经衰弱性头痛多见于脑力劳动者,往往废寝忘食、夜以继日地工作,缺乏锻炼、营养不足、过度疲劳而致大脑不支。患者常有头涨、失眠、记忆力下降表现,并且有未老先衰之感。目前,临床治疗神经性头痛一般用止痛药、镇静药、催眠药及有助于调整和改善神经功能的药物,此类药物起到暂时抑制和缓解疼痛作用,但存在反复发作和副作用大的两大难题。
发明内容
本发明的目的为克服上述的现有技术缺陷,而提供一种无毒副作用、易于吸收,有效治疗神经性头痛疾病的药物组合物及制备方法。
本发明的目的是这样实现的:
一种治疗神经性头痛的药物组合物,是由下列原料按重量份经过水提取、浓缩、减压干燥、粉碎制丸而成:
红参8~23 万年蒿17~33 大黄17~33 鸡血藤18~35
蚂蚁24~43 地龙28~43 松毛60~90。
上述的治疗神经性头痛的药物组合物,原料优选配比为:
红参9 万年蒿20 大黄23 鸡血藤23
蚂蚁26 地龙30 松毛80。
一种如上述的治疗神经性头痛的药物组合物的制备方法,包括以下步骤:
将红参、万年蒿、大黄、鸡血藤、地龙、松毛破碎成5mm粗粉,然后与蚂蚁混合,加14倍量水煎煮三次,每次1小时,合并煎液,滤过、滤液浓缩,减压干燥,粉碎,过80目筛,最后制成丸剂。
进一步地,所述的减压干燥温度在55℃~65℃之间,粉碎过80目筛的药粉与淀粉混合均匀后,用20%淀粉浆为粘合剂制成丸剂。
本发明的丸剂经干燥后分装成小袋, 1克约有10粒左右,每小袋内装7克丸剂。
本发明为朝药制剂领域,属于朝医药学。朝医药学是中国传统医药学的一个重要组成部分,是在朝鲜族固有文化及传统医药学的基础上,吸收中医药学的理论,结合自己防病治病的实践,逐步形成具有独特理论和丰富临床经验的传统医药学体系。 朝医认为神经性头痛主要病机为外感或内伤入络日久,化热化瘀,瘀热互结,上扰腻海所致。本方从朝医肺的生理特点入手,依据头痛之病机,从肺论治头痛。治疗原则为充肺神,清腻海。朝医文献《东医寿世保元》曰:“肺以呼,脾以束…肺充神,脾充气…神疑酸,气完聚,…肺藏意,脾藏魂…意妙伸,魄活动,…肺气直而伸,肺肾之运转,一引而一缩,任呼吸之贵者宜乎,经其终始之贯穿也,肝以充,肺以散,肝肺者散充气道之门户也。…腻海者,肺之根本也……腻海为神之所舍也”。本发明――“松针正脑丸”是由松毛、蚂蚁、万年蒿、红参、地龙、大黄、鸡血藤等七味成分组成,其中松毛:安五脏,延年,红参:补脾和脾,大补元气,止渴生津。蚂蚁:滋阴、补肝益肾、祛湿止痛。三者共奏壮肺而有充足内外之力(内守及外攘之力)。万年蒿:健脾,利湿热,地龙:性寒味咸无毒,大解热毒。大黄:泻下攻积,清热泻火,解毒,泄血之温热,排有形之毒而通肺,三者合用,除肺之瘀热邪气。加用鸡血藤,加强舒筋通络、止痛之效。诸药合用可充肺之神,祛瘀热,使得肺气直而伸,清腻海,具有治疗头痛之效。
本发明药物组合物中松毛安五脏、守中不饥、健脾胜湿、明目为主药;蚂蚁滋阴补肾、祛湿止痛;万年蒿健脾祛湿;红参益气补虚、安神益智、除邪明目;地龙行气活血、定惊;大黄清热泻火、活血止痛;鸡血藤舒筋通络止痛。诸药合用,共奏健脾祛湿,理气活血,安神益智,除邪明目,定惊,止痛之效。全方总以健脾祛湿,理气活血止痛为主,兼以安神益智明目,具有治疗神经性头痛之功效。
本临床治疗总结是由延边朝医医院记录和收集使用本发明药物组合物治疗神经性头痛的门诊病例,共计75例,其中男性患者30例,女性患者45例。
一、资料与方法
1、纳入标准/入选标准
①神经性头痛一个月以上者,年龄在 18~50岁,男女不分;
②除颅内有病灶外其检测结果均未发现异常者;
③无烟酒嗜好;
④心、肝、肾、血液等检查指标均在正常范围;
⑤知情同意,志愿受试。
2、排除标准
①妊娠期、哺乳期妇女;
②经CT、MRI检查颅内有异常病灶者;
③具有原发性心、肝、肾、血液学疾病者;
④精神或法律上的残疾患者;
⑤有酒精、药物滥用病史;
⑥3个月内参加过其他药物临床试验者;
⑦正在应用其他预防和治疗的药物者;
⑧研究者认为不能入组的其他原因。
3、剔除标准
对已被选入本临床研究,属于以下情况之一者,作为剔除病例。
①不符合纳入标准,或符合排除标准者;
②一次药未用者;
③无任何记录者。
4、脱落(退出)标准
对已被选入本临床研究,属于以下情况之一者,作为脱落病例。
①受试者依从性差,不能按时按量用药。
②使用其他影响耐受性判断的药物。
③受试者不愿意继续进行临床试验,向主管医生提出退出者。
5、终止试验标准
①在剂量递增过程中出现了严重不良反应,虽未达到最大剂量,亦应终止试验;
②如半数受试者出现轻度不良反应,应终止试验;
③在达到最大剂量时,虽未出现不良反应,亦应终止试验。
二、研究药物与方法
经对75例神经性头痛患者进行了临床观察,以观察其疗效。
服药方法:
每天2次,治疗时间短期为一个月,长期为半年左右后观察其临床疗效。
三、结果评定的标准
本院研究的评判标准分为治愈、好转、无效三个级别:
①治愈:患者的头痛症状消失,且停止用药1年内未见有复发情况;
②好转:患者的头痛症状基本消失。停药1年内出现复发,但是头痛发作的频率与治疗之前相比较明显减少,头痛症状减轻;
③无效:患者的头痛症状在治疗后和治疗前相比没有明显改善或没有改善,甚至头痛加剧。
五、结果
总有效率=(治愈例数+好转例数)/总例数×100%。
总有效率约95%,临床治愈率约62%,疗效显著,安全可靠,为广大的神经性头痛患者解除了疾病带来的痛苦,并提高了患者的生活质量。
选取5个典型病例,如下:
病例1:张某,女,35岁。头痛有五年,久治不愈。经常出现颈部不适、头痛、头晕,有时出现恶心、呕吐等症状。医院诊断为神经性头痛,经针灸和西药治疗效果都不佳,后来服用本发明药物组合物3个月后,头痛感消失,无其他副作用。
病例2:张某,男,28岁。无诱因出现头痛,每次头痛,伴旋转性眩晕,恶心,耳鸣等症状,医院诊断为神经性头痛。经服用西药治疗效果不佳,后来服用本发明药物组合物2个月后,症状解除,无复发迹象。
病例3:李某,女,50岁。一个月前突发头颈部疼痛,以枕部为主,疼痛呈阵发性,为闪电样锐痛,伴有恶心、呕吐等症状,医院诊断为神经性头痛。后经服用本发明药物组合物2个月后,头痛感消失,此后再无复发。
病例4:张某,男,38岁。头痛四年之久,经常头目眩晕,睡眠不佳,医院确诊为神经性头痛。经中西医治疗,未明显好转,后来服用本发明药物组合物5个月后,头痛消失,无复发情况发生。
病例5:金某,女,15岁。一年前开始经常性左侧头痛,经常性双脚发软、怕冷、抽筋等症状,医院诊断为神经性头痛。经服用中西药物治疗效果不佳,后来服用本发明药物组合物4个月后,病情痊愈,此后再无复发。
具体实施方式
实施例1
一种治疗神经性头痛的药物组合物,是由下列原料按重量份经过水提取、浓缩、减压干燥、粉碎制丸而成:红参10~14、万年蒿18~22、大黄18~22、鸡血藤20~24、蚂蚁30~34、地龙30~34、松毛60~90。
其制备方法,包括以下步骤:
将红参、万年蒿、大黄、鸡血藤、地龙、松毛破碎成5mm粗粉,然后与蚂蚁混合,加14倍量水煎煮三次,每次1小时,合并煎液,滤过、滤液浓缩,减压干燥(55℃~65℃),粉碎,过80目筛,与加入适量淀粉混合均匀,用20%淀粉浆为粘合剂制成丸剂。经干燥后分装成小袋,1克约有10粒左右,每小袋内装7克丸剂,即获得本发明药物组合物成品。
实施例2
一种治疗神经性头痛的药物组合物,是由下列原料按重量份经过水提取、浓缩、减压干燥、粉碎制丸而成:红参8~13、万年蒿17~21、大黄17~21、鸡血藤19~23、蚂蚁29~33、地龙29~33、松毛60~80。
其制备方法,包括以下步骤:
将红参、万年蒿、大黄、鸡血藤、地龙、松毛破碎成5mm粗粉,然后与蚂蚁混合,加14倍量水煎煮三次,每次1小时,合并煎液,滤过、滤液浓缩,减压干燥(55℃~65℃),粉碎,过80目筛,与加入等量淀粉混合均匀,用20%淀粉浆为粘合剂制成丸剂。经干燥后分装成小袋,1克约有10粒左右,每小袋内装7克丸剂,即获得本发明药物组合物成品。
实施例3
一种治疗神经性头痛的药物组合物,是由下列原料按重量份经过水提取、浓缩、减压干燥、粉碎制丸而成:红参15~23、万年蒿20~33、大黄20~33、鸡血藤25~35、蚂蚁25~43、地龙25~43、松毛80~90。
其制备方法同实施例1。
实施例4
一种治疗神经性头痛的药物组合物,是由下列原料按重量份经过水提取、浓缩、减压干燥、粉碎制丸而成:红参8~10、万年蒿17~18、大黄17~18、鸡血藤18~20、蚂蚁27~30、地龙28~30、松毛60~70。
其制备方法同实施例1。
实施例5
一种治疗神经性头痛的药物组合物,是由下列原料按重量份经过水提取、浓缩、减压干燥、粉碎制丸而成:红参9、万年蒿20、大黄23、鸡血藤23、蚂蚁26、地龙30、松毛80。
其制备方法同实施例1。
本发明实施例的用途仅用于说明本发明,而非意欲限制本发明的保护范围。此外,在阅读了本发明的技术内容之后,本领域技术人员可以对本发明作各种改动、修改或变型,所有的这些等价形式同样属于本发明申请所附权利要求书所限定的保护范围之内。
Claims (4)
1.一种治疗神经性头痛的药物组合物,是由下列原料按重量份经过水提取、浓缩、减压干燥、粉碎制丸而成:
红参8~23 万年蒿17~33 大黄17~33 鸡血藤18~35
蚂蚁24~43 地龙28~43 松毛60~90。
2.一种如权利要求1所述的治疗神经性头痛的药物组合物,其特征是由下列原料按重量份经过水提取、浓缩、减压干燥、粉碎制丸而成:
红参9 万年蒿20 大黄23 鸡血藤23
蚂蚁26 地龙30 松毛80。
3.一种如权利要求1所述的治疗神经性头痛的药物组合物的制备方法,包括以下步骤:
将红参、万年蒿、大黄、鸡血藤、地龙、松毛破碎成5mm粗粉,然后与蚂蚁混合,加14倍量水煎煮三次,每次1小时,合并煎液,滤过、滤液浓缩,减压干燥,粉碎,过80目筛,最后制成丸剂。
4.根据权利要求3所述的一种治疗神经性头痛的药物组合物的制备方法,其特征在于所述的减压干燥温度在55℃~65℃之间,粉碎过80目筛的药粉与淀粉混合均匀后,用20%淀粉浆为粘合剂制成丸剂。
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