CN105749026A - 一种治疗癫痫病的中药制剂及其制备方法 - Google Patents
一种治疗癫痫病的中药制剂及其制备方法 Download PDFInfo
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Abstract
本发明公开一种治疗癫痫病的中药制剂及其制备方法,其特征在于,其制备原料包括全蝎、天竺黄、胆南星、天麻、青礞石、蝉蜕、熟地黄、羌活、防风、麻黄和甘草。所述制备方法为将各制备原料预处理,然后粉碎成药粉,将药粉过100目筛,混和均匀,然后按0.45g/粒装入胶囊,装瓶包装,即得。该中药制剂通过临床验证,治疗癫痫病效果显著,特别是对治疗痰火内盛型癫痫疗效作出判定、效果尤佳。同时该药使用安全性、不良反应及禁忌做出的评价均优于市售药品。制备方法简单,易于操作,便于工业化生产与推广。
Description
技术领域
本发明涉及中药技术领域,具体是一种治疗癫痫病的中药制剂及其制备方法。
背景技术
癫痫是一种由多种病因引起的慢性脑部疾病,以大脑神经元过度放电导致反复、发作性和短暂的中枢神经系统功能失常为特征。癫痫发作是指脑神经元异常和过度超同步化放电所造成的临床现象,其特征是突然和一过性症状,由于异常放电的神经元在大脑中的部位不同而又多种多样的表现,可以是运动、感觉、精神或自主神经的,伴有或不伴有意识和警觉程度的变化。
据中国流行病学资料显示,国内癫痫的总体患病率为4-7.0‰,活动性癫痫患病率为4.6‰,年发病率为30/10万左右。据此估计中国约有900万左右的癫痫患者,其中500~600万是活动性癫痫患者,同时每年新增加癫痫患者约40万。在中国癫痫已经成为神经科仅次于头痛的第二大常见病。其主要危害:1、生命的危害:癫痫患者经常会在任何时间、地点、环境下且不能自我控制地突然发作,容易出现摔伤、烫伤、溺水、交通事故等;2、压抑,身心健康受到很大影响;3、认知障碍,主要表现为患者记忆障碍、智力下降、性格改变等,最后逐渐丧失工作能力甚至生活能力。
目前国内外对于癫痫的治疗主要以药物治疗为主。大多数癫痫患者,癫痫患者经过正规的抗癫痫药物治疗,约70%的患者其发作可以得到控制,但仍有20%-30%的受试者癫痫发作不能得到很好的控制,成为难治性癫痫。在应用西药抗癫痫的同时,那么如何进一步提高治疗有效率仍是个严峻的临床问题。祖国医学对癫痫有比较早的研究,通过大量临床实践筛选出了一些卓有成效的单药及经验性成方。中药联合西药治疗,提高了治疗效果,耐受性好。
癫痫发病原因比较复杂,多素体痰湿偏盛;或过食膏梁厚味,痰湿内生。正如张景岳所谓:“盖痰涎之化,本由水谷,使脾强胃健,如少壮者流,则随食而化,皆成血气,焉得留而为痰?唯其不能尽化,而十留一二,则一二为痰矣。十留三四,则三四为痰矣。”痰湿内阻,郁而化热,痰热内盛,痰属土,痰热在中,引发肝木之制,肝受激发而急,故见手足抽搐;肝主筋,肝急而见项背强直;痰热蒙敝清窍而见昏迷不醒;痰热扰心则烦躁不安。本证病机要点为痰热内闭,引动肝风。治宜祛风止痉,清热化痰。
发明内容
提供了一种治疗癫痫病的中药制剂及其制备方法,本中药制剂治疗癫痫病效果显著,特别是对治疗痰火内盛型癫痫效果尤佳。通过临床验证,对该中药制剂治疗痰火内盛型癫痫病疗效作出判定,同时对该药使用的安全性、不良反应及禁忌做出评价。
为了解决上述的技术问题,本发明采用的基本技术方案为:一种治疗癫痫病的中药制剂,其特征在于,其制备原料包括全蝎、天竺黄、胆南星、天麻、青礞石、蝉蜕、熟地黄、羌活、防风、麻黄和甘草。上述制备原料的重量比含量分别为全蝎30.4、天竺黄36.5、胆南星36.5、天麻60.8、青礞石60.8、蝉蜕36.5、熟地黄91.2、羌活18.2、防风30.4、麻黄18.2、甘草30.4。
本发明还提供一种治疗癫痫病的中药制剂的制备方法,其特征在于,采用上述制备原料和下述步骤:
1)取制备原料各药,挑选,去杂质,然后置于燥箱中于80℃下干燥4小时,凉后取出;
2)按制备原料各药的重量比含量称取全蝎、天竺黄、胆南星、天麻、青礞石、蝉蜕、熟地黄、羌活、防风、麻黄、甘草,混合均匀,粉碎成药粉;
3)将药粉过100目筛,混和均匀,然后按0.45g/粒装入胶囊,装瓶包装,即得。
本发明与现有技术相比,其有益效果在于:方中全蝎、蝉蜕均能归肝经,善于祛风止痉,共为君药。天竺黄归心肝经,能清热化痰,清心定惊,善于治疗痰热惊搐;胆南星苦凉,有清热化痰,息风定惊之功;青礞石既能攻消痰积,又能平肝镇惊,善于治疗痰热壅塞引起的惊风抽搐。天麻归肝经,味甘质润,长于平肝而息风止痉;羌活、防风均为辛温行散之品,能祛风散邪,防风又能解痉。天竺黄、胆南星、青礞石、天麻、羌活、防风加强君药治疗作用,共为臣药。痰热内盛,易伤津液,故以熟地滋阴养血,柔肝舒筋;麻黄加强祛风作用,为佐药。甘草缓急和药,为使药。全方相合,祛风止痉,清热化痰,则诸症可治,治疗癫痫取效显著。该中药制剂通过临床验证,治疗癫痫病效果显著,特别是对治疗痰火内盛型癫痫疗效作出判定、效果尤佳。同时该药使用安全性、不良反应及禁忌做出的评价均优于市售药品。
具体实施方式
以下将结合具体实施例对本发明做进一步的说明,但不应以此来限制本发明的保护范围。
一种治疗癫痫病的中药制剂(简称中药制剂),其特征在于,其制备原料包括全蝎、天竺黄、胆南星、天麻、青礞石、蝉蜕、熟地黄、羌活、防风、麻黄和甘草。上述制备原料的重量比含量分别为全蝎30.4、天竺黄36.5、胆南星36.5、天麻60.8、青礞石60.8、蝉蜕36.5、熟地黄91.2、羌活18.2、防风30.4、麻黄18.2、甘草30.4。上述制备原料的重量比含量数字仅用于限定各原料之间的相对重量关系,即按上述数字配制的制备原料,重量单位为一致,且在增大或减少相同倍数用量的情况下的配方,均在本发明的保护范围之内。
本发明还提供一种治疗癫痫病的中药制剂的制备方法,其特征在于,采用上述制备原料和下述步骤:
4)取制备原料各药,挑选,去杂质,然后置于燥箱中于80℃下干燥4小时,凉后取出;
5)按制备原料各药的重量比含量称取全蝎、天竺黄、胆南星、天麻、青礞石、蝉蜕、熟地黄、羌活、防风、麻黄、甘草,混合均匀,粉碎成药粉;
6)将药粉过100目筛,混和均匀,然后按0.45g/粒装入胶囊,装瓶包装,即得。
实施例
本实施例提供一种治疗癫痫病的中药制剂及其制备方法。
所述中药制剂的制备原料为:
所述中药制剂的制备方法为:
1)取制备原料各药,挑选,去杂质,然后置于燥箱中于80℃下干燥4小时,凉后取出;
2)按制备原料各药的重量比含量称取全蝎30.4g、天竺黄36.5g、胆南星36.5g、天麻60.8g、青礞石60.8g、蝉蜕36.5g、熟地黄91.2g、羌活18.2g、防风30.4g、麻黄18.2g、甘草30.4g,混合均匀,粉碎成药粉;
3)将药粉过100目筛,混和均匀,然后按0.45g/粒装入胶囊,装瓶包装,即得。
临床试验
治疗时,设置本发明制备的中药制剂的服用方法为:口服,一次4粒,一日三次,4周一疗程。
临床资料:
病例数:
(1)试验组:100例
(2)对照组:100例
研究者按照受试者就诊先后顺序,采取随机分组方法将入选患者分成两组:试验组和对照组。
治疗方案:
试验药:本发明制备的中药制剂,按实施例所述方法制备,规格:0.45g/粒。
对照药:痫愈胶囊,由玉田安康医院提供,规格:0.4g/粒。
给药方法
试验组:每日3次,每次4粒,餐后口服。
对照组:每日3次,每次5粒,餐后口服。
疗程:4周。
合并用药
丙戊酸镁缓释片,每日2次,每次0.25g,餐后口服。
舒朗注射液(盐酸赖氨酸氯化钠注射液),每日1次,每次3.0g,静脉滴注。
吡拉西坦注射液,每日1次,每次4.0g,静脉滴注。
维生素B6注射液,每日1次,每次100mg,静脉滴注。
以上合并用药根据年龄、体重,病情,血药浓度等可适当调整用量。
疗效观察指标
依据国家中医药管理局脑病急症协作组起草制定的《癫痫诊断与疗效评定标准》(试行)制定此标准。
主要疗效指标:
维持期4周癫痫发作次数和每次发作持续时间。分别对试验组和对照组发作频率、发作持续时间是否减少进行描述。并对较基线减少率进行比较分析。
次要疗效指标:
1)西医症状:维持期4周,强直、抽搐程度,意识状态程度,缓解后恢复意识状态时间,呼吸停止,尿失禁等发作症状较基线减少率。
2)中医证候:维持期4周狂躁不安、舌红苔黄腻,脉滑数等中医证候较基线减少率。
疗效评价标准
根据国家中医药管理局脑病急症协作组起草制定的《癫痫诊断与疗效评定标准》(试行)制定癫痫病中医疗效评定标准:采用计分法,着眼于意识障碍及其持续时间,强直、抽搐的程度及持续时间,脑电图的变化,同时结合发作频率的变化判断疗效。
根据国家中医药管理局脑病急症协作组起草制定的《癫痫诊断与疗效评定标准》(试行)制定癫痫病疗效评定标准:
基本控制:疗效百分数>=70%,或<70%,发作频率减小75%。
显效:疗效百分数>=40%,而<70%,或发作频率减少75%。
有效:疗效百分数>=40%,而<70%,或发作频率减少50%。
效差:疗效百分数>=20%,而<40%,或发作频率减少在25%~50%。
无效:疗效百分数>=20%,或发作频率减少<25%。
治疗效果:
试验组:用药28天,显效89例,占89%;有效10例,占10%;无效1例,1%。
对照组:用药28天,显效65例,占65%;有效23例,占23%;无效12例,12%。
由治疗效果数据可以看到,本发明的中药制剂与现有技术中的药物相比,其效果明显好于现有技术中的药物。
根据上述说明书的揭示和教导,本发明所属领域的技术人员还可以对上述实施方式进行变更和修改。因此,本发明并不局限于上面揭示和描述的具体实施方式,对本发明的一些修改和变更也应当落入本发明的权利要求的保护范围内。此外,尽管本说明书中使用了一些特定的术语,但这些术语只是为了方便说明,并不对本发明构成任何限制。
本发明未述及之处适用于现有技术。
Claims (4)
1.一种治疗癫痫病的中药制剂,其特征在于,其制备原料包括全蝎、天竺黄、胆南星、天麻、青礞石、蝉蜕、熟地黄、羌活、防风、麻黄和甘草。
2.根据权利要求1所述的一种治疗癫痫病的中药制剂,其特征在于,所述制备原料的重量比含量分别为全蝎30.4、天竺黄36.5、胆南星36.5、天麻60.8、青礞石60.8、蝉蜕36.5、熟地黄91.2、羌活18.2、防风30.4、麻黄18.2、甘草30.4。
3.根据权利要求1所述的一种治疗癫痫病的中药制剂,其特征在于,所述制备原料的含量分别为全蝎30.4g、天竺黄36.5g、胆南星36.5g、天麻60.8g、青礞石60.8g、蝉蜕36.5g、熟地黄91.2g、羌活18.2g、防风30.4g、麻黄18.2g、甘草30.4g。
4.一种治疗癫痫病的中药制剂的制备方法,其特征在于,采用按权利要求2-3任一项所述的制备原料和下述步骤:
1)取制备原料各药,挑选,去杂质,然后置于燥箱中于80℃下干燥4小时,凉后取出;
2)按制备原料各药的重量比含量称取全蝎、天竺黄、胆南星、天麻、青礞石、蝉蜕、熟地黄、羌活、防风、麻黄、甘草,混合均匀,粉碎成药粉;
3)将药粉过100目筛,混和均匀,然后按0.45g/粒装入胶囊,装瓶包装,即得。
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