CN106389728A - 一种治疗原发性三叉神经痛的药物组合物 - Google Patents
一种治疗原发性三叉神经痛的药物组合物 Download PDFInfo
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Abstract
本发明属于中医药技术领域,涉及一种治疗原发性三叉神经痛的药物组合物及其制备方法。该药物组合物主要由灯台莲、胆南星、水菖蒲、白芥子、黄连、丝瓜络、向日葵花盘、天仙藤、徐长卿、枸骨叶、白芷为药用原料制成。诸药相互作用,互相为用有化痰泄热,祛风通络之效,痛得以止而奏效,针对痰火上攻型三叉神经痛而辨证用药,临床疗效确切,副作用较小。
Description
技术领域
本发明属于中医药技术领域,涉及一种治疗原发性三叉神经痛的药物组合物及其制备方法。
背景技术
原发性三叉神经痛为突发性和阵发性的三叉神经分布区域内的针刺、刀割样剧痛,难以忍受,多为一侧,以第二支、第三支多见。疼痛时可伴有面肌抽搐、面红、结膜充血、
流泪;发作只持续数秒及1~2min;发作过后,一切如常;常有明显的发作诱因如刷牙、吃饭、说话等;面部常有触发点(扳机点),常因触及某个敏感点而引起发作。扳机点常位于额部、上唇鼻侧及下唇。多发生于40岁龄以上的成年女性及老年人。原发性三叉神经痛是目前临床上众多难治疾病之一,影响患者的的工作和学习,降低患者的生活质量,故寻求一种安全,有效,简单经济的治疗原发性三叉神经痛的的方法仍具有临床研究价值。
关于三叉神经痛的治疗方法有许多种,从单纯的口服药物治疗、物理疗法,到各药物注射封闭治疗以及手术切断、撕脱术、射频温控热凝术、微血管减压术等。治疗三叉神经痛临床常用方法主要有手术、伽马刀、射频术、封闭、激光、口服西药等等。这些方法多通过抑制神经、阻滞神经、破坏神经,致使三叉神经失去正常的生理功能,达到暂时止痛的作用。不仅治疗时间长,治疗费用也相对较高;有的甚至会导致损伤脑神经或脑组织,也有出现失明、脑出血、面部麻痹等严重后遗症。西药副作用较为明显,一些患者使用后出现头晕乏力,恶心呕吐,白细胞减少,皮疹等不良反应。
祖国医学对原发性三叉神经痛的认识历史悠久,疗效显著。中医将原发性三叉神经痛归为“面痛”、“偏头痛”、“头痛”、“头风”、“颊痛”、“齿槽风”、“面游风”等。祖国医学对原发性三叉神经痛的认识历史悠久。现代多认为本病的发生无外乎外感和内伤,同时与风邪密切相关,大凡外感致病,因高巅之上,唯风可达,风邪升发,易犯头面,风邪每与寒、火、痰兼夹合邪,以致风寒凝滞,或风火灼伤,或风痰壅阻三阳经络而发为疼痛。中医辨证治疗原发性三叉神经痛临床效果较为显著,毒副作用较少,反复发作次数少,而且方法丰富。
发明内容
针对目前三叉神经痛临床治疗药物的不足,本发明的第一个目的在于提供一种治疗原发性三叉神经痛的药物组合物,该药物组合物在辨证治疗原发性三叉神经痛时具有治疗效果显著、副作用小、长期使用效果好的治疗优势,有很好医学应用前景。
一种治疗原发性三叉神经痛的药物组合物,其特征在于其主要由灯台莲、胆南星、水菖蒲、白芥子、黄连、丝瓜络、向日葵花盘、天仙藤、徐长卿、枸骨叶、白芷为药用原料制成。
其中,上述所述治疗原发性三叉神经痛的药物组合物中各药用原料的重量份配比如下:胆南星7-12份、水菖蒲10-15份、灯台莲3-5份、白芥子5-8份、黄连4-7份、向日葵花盘15-20份、丝瓜络10-15份、天仙藤8-13份、徐长卿7-12份、枸骨叶13-18份、白芷2.5-4.0份。
本发明上述所述药物组合物中还可以含有薄荷4-7份、车前子8-13份。
进一步优选地,一种治疗原发性三叉神经痛的药物组合物,其由下述重量份配比的药用原料制成:胆南星9份、水菖蒲12份、灯台莲3份、白芥子7份、黄连4.5份、向日葵花盘20份、丝瓜络10份、天仙藤12份、徐长卿10份、枸骨叶15份、白芷3.0份、薄荷5份、车前子12份。
本发明方解:胆南星清热化痰,息风定惊;水菖蒲化痰开窍,除湿健胃,与胆南星伍用有熄风豁痰,清热除湿,行气除壅之效,为治痰火上攻型三叉神经痛之君药。白芥子利气豁痰,化痰逐饮,散结;灯台莲燥湿化痰,熄风止痉,消肿止痛;黄连清热燥湿,泻火解毒;向日葵花盘清热,平肝,止痛,四药伍用化痰泄热为臣药。丝瓜络通络,活血祛风,化痰顺气;天仙藤行气活血,治一切诸痛之药也,兼能利水消肿;徐长卿祛风化湿,止痛止痒;枸骨叶能补养阴气使痰火自消,为釜底抽薪之意;白芷散风除湿,通窍止痛,引药上行,五药助君臣药搜风通络,通窍止痛,清透相谐,使痰火有内清外达之机。诸药相互作用,互相为用有化痰泄热,祛风通络之效,痛得以止而奏效,针对痰火上攻型三叉神经痛而辨证用药。
薄荷、车前子联用有清透相谐,泻火化痰之效,可以显著增强机体的免疫能力,而且二种药物与本发明上述药物组合物联用可进一步增强其对痰火上攻型三叉神经痛的治疗效果。
本发明各药用原料的药理作用如下:
灯台莲:【性味】味苦、辛;性温。【归经】肺;肝经。【功能主治】燥湿化痰;熄风止痉;‘消肿止痛。主痰湿咳嗽;风痰眩晕;癫痫;中风;口眼歪斜;破伤风;痈肿;毒蛇咬伤。
胆南星:【性味】苦、微辛,凉。【归经】归肺、肝、脾经。【功能主治】清热化痰,息风定惊。用于痰热咳嗽,咯痰黄稠,中风痰迷,癫狂惊痫。
水菖蒲:【性味】味辛;苦;性温。【归经】心;肝;胃经。【功能主治】化痰开窍;除湿健胃;杀虫止痒。主痰厥昏迷;中风;癫痫;惊悸健忘;耳鸣耳聋;食积腹痛;痢疾泄泻;风湿疼痛;湿疹;疥疮。
白芥子:【性味】辛;温。【归经】肺;肝;脾;胃;心包经。【功能主治】化痰逐饮;散结消肿。主咳喘痰多;胸满胁痛;肢体麻木;关节肿痛;湿痰流注;阴疽肿毒。
黄连:【性味】苦,寒。【归经】归心、脾、胃、肝、胆、大肠经。【功能主治】清热燥湿,泻火解毒。用于湿热痞满,呕吐吞酸,泻痢,黄疸,高热神昏,心火亢盛,心烦不寐,血热吐衄,目赤,牙痛,消渴,痈肿疔疮;外治湿疹,湿疮,耳道流脓。酒黄连善清上焦火热。用于目赤,口疮。姜黄连清胃和胃止呕。用于寒热互结,湿热中阻,痞满呕吐。萸黄连舒肝和胃止呕。用于肝胃不和,呕吐吞酸。【用法用量】2~5g。外用适量。
丝瓜络:【性味】甘,平。【归经】归肺、胃、肝经。【功能主治】通络,活血,祛风。用于痹痛拘挛,胸胁胀痛,乳汁不通。【用法用量】4.5~9g。
向日葵花盘:【性味】味甘;性寒。【归经】归肝经。【功能主治】清热;平肝;止痛;止血。主高血压;头痛;头晕;耳鸣;脘腹痛;痛经;子宫出血;疮疹。【用法用量】内服:煎汤,15-60g。外用:适量,捣敷;或研粉敷。
天仙藤:【性味】苦;温。【归经】肝;脾;肾经。【功能主治】行气活血;利水消肿;解毒。主胃痛;疝气痛;妊娠水肿;产后血气腹痛;蛇虫咬伤。
徐长卿:【性味】辛,温。【归经】归肝、胃经。【功能主治】祛风化湿,止痛止痒。用于风湿痹痛,胃痛胀满,牙痛,腰痛,跌扑损伤,荨麻疹、湿疹。【用法用量】3~12g,入煎剂宜后下。
枸骨叶:【性味】苦,凉。【归经】归肝、肾经。【功能主治】清热养阴,平肝,益肾。用于肺痨咯血,骨蒸潮热,头晕目眩;高血压。【用法用量】9~15g。
白芷【来源】伞型科植物白芷的干燥根。【性味】辛,温。【归经】归胃、大肠、肺经。【功能主治】散风除湿,通窍止痛,消肿排脓。用于感冒头痛,眉棱骨痛,鼻塞,鼻渊,牙痛,白带,疮疡肿痛。
薄荷:【性味】辛,凉。【归经】归肺、肝经。【功能主治】宣散风热。清头目,透疹。用于风热感冒,风温初起,头痛,目赤,喉痹,口疮,风疹,麻疹,胸胁胀闷。【用法用量】3~6g,入煎剂宜后下。
车前子:【性味】甘,微寒。【归经】归肝、肾、肺、小肠经。【功能主治】清热利尿,渗湿通淋,明目,祛痰。用于水肿胀满,热淋涩痛,暑湿泄泻,目赤肿痛,痰热咳嗽。【用法用量】9~15g,入煎剂宜包煎。
为了更好的表达本发明的药物组合物,本发明的药物组合物可由灯台莲、胆南星、水菖蒲、白芥子、黄连、丝瓜络、向日葵花盘、天仙藤、徐长卿、枸骨叶、白芷或灯台莲、胆南星、水菖蒲、白芥子、黄连、丝瓜络、向日葵花盘、天仙藤、徐长卿、枸骨叶、白芷、薄荷、车前子的水或/和有机溶剂提取物为活性成分,依照制剂学常规技术制成各种剂型。
本发明的上述所述药物组合物可以加入制备不同剂型时所需的各种常规辅料或辅助性成分,以常规的药物组合物方法制备成任何一种常用的口服制剂,例如可以是片剂、糖衣片剂、薄膜衣片剂、肠溶衣片剂、胶囊剂、硬胶囊剂、软胶囊剂、口服液、颗粒剂、冲剂、丸剂、散剂、混悬剂、粉剂。
优选地,上述所述的口服剂型为胶囊剂、片剂或丸剂。
最优选地,上述所述的口服剂型是胶囊剂。
本发明的另一个目的是提供一种制备治疗原发性三叉神经痛的药物组合物的方法。
本发明提供的一种治疗原发性三叉神经痛的药物组合物的制备方法,其特征在于包括以下步骤:
(1)取天仙藤、白芥子、白芷,还可以包括薄荷、车前子粉碎成平均粒径为10-60μm的颗粒后加入5-10倍量的60%的乙醇水溶液,采用超声波提取,超声波提取完毕,取滤液,减压浓缩成稠膏得提取物A,备用,其中,提取条件包括:超声功率为130-160W,提取温度为30-50℃,提取时间为10-50min;
(2)将灯台莲、水菖蒲、黄连、丝瓜络、向日葵花盘、徐长卿、枸骨叶加水煎煮两次,第一次煎煮1.0-2.0小时,加水量为煎煮药材总重量的6-10倍,第二次煎煮1.0-1.5小时,加水量为煎煮药材总重量的4-7倍,合并煎液,滤过,滤液减压浓缩,加入乙醇至浓度为30%,于-5~5℃冷藏12小时,滤过,滤液回收乙醇,浓缩得稠膏得提取物B,备用:
(3)将胆南星粉碎成120-200目的细粉,优选为200目的细粉,与提取物A、提取物B混合均匀,加入辅料或辅助性成分混匀,按照本领域常规制剂工艺制成药剂学上适宜的剂型。如片剂、胶囊剂、丸剂等。
本发明的制剂在使用时根据病人的情况确定用法用量。本发明的制剂在使用时根据病人的情况确定用法用量,可每日服1-3次,每次1-20剂,如:1-20丸或粒或片等。
本发明是发明人经过反复研究,逐步改进,并在临床实践中检验和发展而成的一种疗效较好的治疗原发性三叉神经痛药物。通过实施例11临床观察试验可知:使用本发明药物对47例原发性三叉神经痛患者的临床观察表明,本发明药物能有效解除或缓解疼痛,明显消除中医症状,解除患者痛苦。其止痛效果优于西药卡马西平,在减少发生频度方面优于卡马西平。而且在服用期间未出现任何不良反应,因此对于治疗三叉神经痛具有自己独特的优势,因为本发明还请求保护上述所述药物组合物在制备治疗原发性三叉神经痛药物中的用途。
与现有技术相比,本发明既遵循了中医辨证用药规律,又融入了现代药理,立法全面,按照君臣佐使原则配伍严谨组方,具有多靶点、多环节、多层次的综合调控作用,是治疗原发性三叉神经痛的理想中药复方;同时,临床疗效确切,副作用较小,患者依从性较好,服用方便,可有效地减轻病者负担和痛苦,能够达到标本兼治的目的,值得临床上广泛推广应用。
具体实施方式
以下通过具体实施例进一步描述本发明,本发明不仅仅限于以下实施例。在本发明的范围内或者在不脱离本发明的内容、精神和范围内,对本发明进行的变更、组合或替换,对于本领域的技术人员来说是显而易见的,且包含在本发明的范围之内。
实施例1胶囊剂
处方:胆南星9份、水菖蒲12份、灯台莲3份、白芥子7份、黄连4.5份、向日葵花盘20份、丝瓜络10份、天仙藤12份、徐长卿10份、枸骨叶15份、白芷3.0份、薄荷5份、车前子12份。
制备方法:(1)取天仙藤、白芥子、白芷、薄荷、车前子,粉碎成平均粒径为10-60μm的颗粒后加入5-10倍量的60%的乙醇水溶液,采用超声波提取,超声波提取完毕,取滤液,减压浓缩成稠膏得提取物A,备用,其中,提取条件包括:超声功率为130-160W,提取温度为30-50℃,提取时间为10-50min;
(2)将灯台莲、水菖蒲、黄连、丝瓜络、向日葵花盘、徐长卿、枸骨叶加水煎煮两次,第一次煎煮1.0-2.0小时,加水量为煎煮药材总重量的6-10倍,第二次煎煮1.0-1.5小时,加水量为煎煮药材总重量的4-7倍,合并煎液,滤过,滤液减压浓缩,加入乙醇至浓度为30%,于-5~5℃冷藏12小时,滤过,滤液回收乙醇,浓缩得稠膏得提取物B,备用:
(3)将胆南星粉碎成200目的细粉,与提取物A、提取物B混合均匀,按照本领域常规制剂工艺制成胶囊剂,每粒装量0.35g,相当于生药1.1g。
实施例2胶囊剂
处方:胆南星8份、水菖蒲12份、灯台莲3.5份、白芥子6份、黄连5份、向日葵花盘15份、丝瓜络12份、天仙藤12份、徐长卿8份、枸骨叶14份、白芷3.0份、薄荷5份、车前子10份。
制备方法:参照实施例1的操作进行。
实施例3胶囊剂
处方:胆南星12份、水菖蒲10份、灯台莲5份、白芥子5份、黄连6份、向日葵花盘20份、丝瓜络15份、天仙藤10份、徐长卿7份、枸骨叶15份、白芷3.5份、薄荷4份、车前子12份。
制备方法:参照实施例1的操作进行。
实施例4胶囊剂
处方:胆南星7份、水菖蒲12份、灯台莲4份、白芥子5份、黄连6份、向日葵花盘18份、丝瓜络12份、天仙藤10份、徐长卿8份、枸骨叶18份、白芷4.0份、薄荷5份、车前子10份。
制备方法:参照实施例1的操作进行。
实施例5胶囊剂
处方:胆南星10份、水菖蒲10份、灯台莲4份、白芥子8份、黄连5.5份、向日葵花盘15份、丝瓜络12份、天仙藤8份、徐长卿8份、枸骨叶18份、白芷4.0份、薄荷7份、车前子10份。
制备方法:参照实施例1的操作进行。
实施例6胶囊剂
处方:胆南星9份、水菖蒲12份、灯台莲3份、白芥子7份、黄连4.5份、向日葵花盘20份、丝瓜络10份、天仙藤12份、徐长卿10份、枸骨叶15份、白芷3.0份。
制备方法:(1)取天仙藤、白芥子、白芷,粉碎成平均粒径为10-60μm的颗粒后加入5-10倍量的60%的乙醇水溶液,采用超声波提取,超声波提取完毕,取滤液,减压浓缩成稠膏得提取物A,备用,其中,提取条件包括:超声功率为130-160W,提取温度为30-50℃,提取时间为10-50min;
(2)将灯台莲、水菖蒲、黄连、丝瓜络、向日葵花盘、徐长卿、枸骨叶加水煎煮两次,第一次煎煮1.0-2.0小时,加水量为煎煮药材总重量的6-10倍,第二次煎煮1.0-1.5小时,加水量为煎煮药材总重量的4-7倍,合并煎液,滤过,滤液减压浓缩,加入乙醇至浓度为30%,于-5~5℃冷藏12小时,滤过,滤液回收乙醇,浓缩得稠膏得提取物B,备用:
(3)将胆南星粉碎成120-200目的细粉,优选为200目的细粉,与提取物A、提取物B混合均匀,按照本领域常规制剂工艺制成。
实施例7胶囊剂
处方:胆南星10份、水菖蒲15份、灯台莲3份、白芥子5份、黄连4.5份、向日葵花盘18份、丝瓜络12份、天仙藤12份、徐长卿12份、枸骨叶15份、白芷3.0份。
药物组合物含有薄荷4-7份、车前子8-13份。
制备方法:参照实施例6的操作进行。
实施例8片剂
处方:胆南星7份、水菖蒲15份、灯台莲4份、白芥子8份、黄连4.5份、向日葵花盘20份、丝瓜络12份、天仙藤12份、徐长卿8份、枸骨叶16份、白芷3.5份、薄荷5份、车前子10份。
制备方法:(1)取天仙藤、白芥子、白芷、薄荷、车前子,粉碎成平均粒径为10-60μm的颗粒后加入5-10倍量的60%的乙醇水溶液,采用超声波提取,超声波提取完毕,取滤液,减压浓缩成稠膏得提取物A,备用,其中,提取条件包括:超声功率为130-160W,提取温度为30-50℃,提取时间为10-50min;
(2)将灯台莲、水菖蒲、黄连、丝瓜络、向日葵花盘、徐长卿、枸骨叶加水煎煮两次,第一次煎煮1.0-2.0小时,加水量为煎煮药材总重量的6-10倍,第二次煎煮1.0-1.5小时,加水量为煎煮药材总重量的4-7倍,合并煎液,滤过,滤液减压浓缩,加入乙醇至浓度为30%,于-5~5℃冷藏12小时,滤过,滤液回收乙醇,浓缩得稠膏得提取物B,备用:
(3)将胆南星粉碎成120-200目的细粉,优选为200目的细粉,与提取物A、提取物B混合均匀,按照本领域常规制剂工艺制成片剂,每片0.4g,相当于生药0.9g。
实施例9丸剂
处方:胆南星9份、水菖蒲12份、灯台莲3份、白芥子7份、黄连4.5份、向日葵花盘20份、丝瓜络10份、天仙藤12份、徐长卿10份、枸骨叶15份、白芷3.0份、薄荷5份、车前子12份。
制备方法:(1)取天仙藤、白芥子、白芷,粉碎成平均粒径为10-60μm的颗粒后加入5-10倍量的60%的乙醇水溶液,采用超声波提取,超声波提取完毕,取滤液,减压浓缩成稠膏得提取物A,备用,其中,提取条件包括:超声功率为130-160W,提取温度为30-50℃,提取时间为10-50min;
(2)将灯台莲、水菖蒲、黄连、丝瓜络、向日葵花盘、徐长卿、枸骨叶加水煎煮两次,第一次煎煮1.0-2.0小时,加水量为煎煮药材总重量的6-10倍,第二次煎煮1.0-1.5小时,加水量为煎煮药材总重量的4-7倍,合并煎液,滤过,滤液减压浓缩,加入乙醇至浓度为30%,于-5~5℃冷藏12小时,滤过,滤液回收乙醇,浓缩得稠膏得提取物B,备用:
(3)将胆南星粉碎成120-200目的细粉,优选为200目的细粉,与提取物A、提取物B混合均匀,按照本领域常规制剂工艺制成丸剂,每10丸重2.5g,相当于生药2.0g。
实施例10毒理学试验
1、急性毒性试验报告
试验方法:以本发明实施例1的胶囊剂为对象,选择20只成年白鼠进行试验,临床日用量的100倍给试验组的20只白鼠大肠内投药,观察7日。结果20只白鼠均健存,其活动、饮食、毛发、排泄物未发现异常,未见毒性反应。
2、慢性毒性试验报告:
试验方法:以本发明实施例1的胶囊剂为对象,取30只成熟的生命体征相同的家兔作为对象,雌雄参半,将其随机划分为5个组,1个空白组和3个试验组,将药物混入家兔的饲料中对4组试验组进行喂食。实验一组喂食临床日常剂量的4倍,试验二组喂食临床剂量的8倍,试验三组喂食临床剂量的20倍。用药进行30天,通过比较用药前、用药30天、以及停药30天后的家兔的行为、精神状态、粪便等变化,来进行药物的毒性检测。通过对试验组的家兔观察,喂药后的家兔,在行为、精神状态以及粪便等方面,与未投药的家兔,无任何区别。因此,该药物长期服用,不具有蓄积毒性,不会在体内淤积毒素。
实施例11临床观察试验:
1资料与方法
1.1一般资料:94例均来自2014年1月-2014年12月我院神经科门诊确证的患者;其中男43例,女53例,年龄18~67岁,平均年龄55.3±7.8岁;病程3个月~10余年,平均2.5±3.1年;其中第2支疼痛者24例,第3支疼痛者38例,第2支(上颌支)、第3支疼痛者26例。96例中首次发病者41例,反复2次以上发作者53例,随机分为治疗组和对照组,两组一般资料对比无显著性差异(P>0.05),具有可比性。
1.2诊断标准
1.2.1西医诊断标准:参照1998年国际头痛学会分类委员会制定的三叉神经痛标准:①面部或额部的阵发性疼痛,持续几秒钟至2分钟;②疼痛至少有下列特点中的4项:沿三叉神经的一支或几支散布;特征为突发、剧烈、尖锐、浅表、刀刺样或烧灼样;疼痛剧烈;从扳机点促发或因某些日常活动诱发,如吃饭、谈话、洗脸或刷牙;发作以后,病人完全无症状;③无神经系统体征;④每位患者有刻板的发作;⑤病史躯体检查及必要时所做特殊检查可排除导致面痛的其他原因。
临床分级标准:轻度:每日发作10次以下;中度:每日发作10-30次;重度:每日发作30次以上。
1.2.2中医辩证标准:参照《中药新药临床研究指导原则》制定痰火上攻症型,证见:患侧头面呈胀闷剧痛,局部喜冷,口干不欲饮,头昏头重,胸痞脘闷,口吐痰涎,舌苔黄厚而腻,脉弦滑。
1.3病例排除标准:排除己采用过药物、电凝、手术等使神经纤维破坏,功能丧失者;妊娠或哺乳期妇女,过敏体质者;合并心血管、脑血管、肝、肾和造血系统等严重原发性疾病、精神病患者;不符合纳入标准、未按规定用药无法判定疗效,或资料不全等影响疗效或安全性判断者。
1.4治疗组给予本发明实施例1的胶囊剂,每次3-6粒,饭后半小时后服用,每日三次;对照组给予卡马西平每次0.1g,每日3次。两组均以14天为一个疗程,治疗时间2个疗程。
1.5观测指标
1.5.1安全性观测:一般体检项目、血、尿、大便常规化验;心、肝、肾功能检验;
1.5.2有效性观测:面部疼痛的时间、次数、程度、部位和性质;全身症状:寒热的喜恶、饮食、二便等;舌脉的变化。
1.6疗效标准:治疗后疼痛及各种症状消失,随诊1年以上未复发者为治愈;治疗后疼痛消失,停药后复发,再次治疗后疼痛消失为好转;治疗2个疗程后疼痛减轻,但未完全消失,或发作次数减少者为有效;治疗2个疗程,疼痛未减轻,发作次数未减少或病情加重者为无效。
1.7统计学方法:采用SPSS15.0统计软件进行计算。各数值以表示,计量资料采用t检验,计数资料采用χ2检验,以P<0.05为差异有统计学意义。
2结果
2.1两组患者疗效比较:上述94例患者治疗后,治疗组治愈18例,显效22例,有效5例,无效2例,显效率85.1%,总有效率95.7%;对照组治愈11例,显效18例,有效12例,无效6例,显效率61.7%,总有效率87.2%,治疗组与对照组显效率、总有效率比较,差异有统计学意义(P<0.05),说明治疗组较对照组可以明显的提高原发性三叉神经痛的临床治愈率及显效率。见表1。
表1两组患者疗效比较(n%,例)
注:与对照组比较,*P<0.05。
2.2两组治疗前后疼痛情况比较:治疗前两组疼痛频度、疼痛程度比较,差异无统计学意义,治疗后两组疼痛频度、疼痛程度均低于治疗前,差异有统计学意义(P<0.01),治疗后两组间疼痛频度比较,治疗组更低,差异有统计学意义(P<0.05),治疗后两组间疼痛程度比较,治疗组更低,差异有统计学意义(P<0.05)。见表2。
表2两组治疗前后疼痛情况比较
注:与治疗前比较,*P<0.05,**P<0.01;与治疗后对照组比较,#P<0.05。
2.3不良反应:在观察期间,治疗组病人无任何主观不适,血、尿、大便常规及心、肝、肾功能等检查均未出现异常,安全性评价为1级。对照组中出现眩晕、共济失调3例;胃肠道反应2例;嗜睡3例,两组不良反应比较,差异有统计学意义,治疗组不良反应更少。
Claims (9)
1.一种治疗原发性三叉神经痛的药物组合物,其特征在于其主要由灯台莲、胆南星、水菖蒲、白芥子、黄连、丝瓜络、向日葵花盘、天仙藤、徐长卿、枸骨叶、白芷为药用原料制成。
2.如权利要求1所述的治疗原发性三叉神经痛的药物组合物,其特征在于其主要由下述重量份配比的药用原料制成:胆南星7-12份、水菖蒲10-15份、灯台莲3-5份、白芥子5-8份、黄连4-7份、向日葵花盘15-20份、丝瓜络10-15份、天仙藤8-13份、徐长卿7-12份、枸骨叶13-18份、白芷2.5-4.0份。
3.如权利要求2所述的治疗原发性三叉神经痛的药物组合物,其特征在于所述药物组合物含有薄荷4-7份、车前子8-13份。
4.如权利要求3所述的治疗原发性三叉神经痛的药物组合物,其特征在于由下述重量份配比的药用原料制成:胆南星9份、水菖蒲12份、灯台莲3份、白芥子7份、黄连4.5份、向日葵花盘20份、丝瓜络10份、天仙藤12份、徐长卿10份、枸骨叶15份、白芷3.0份、薄荷5份、车前子12份。
5.如权利要求1-4任一所述的治疗原发性三叉神经痛的药物组合物,其特征在于所述药物组合物制成口服剂型,例如可以是片剂、糖衣片剂、薄膜衣片剂、肠溶衣片剂、胶囊剂、硬胶囊剂、软胶囊剂、口服液、颗粒剂、冲剂、丸剂、散剂、混悬剂、粉剂。
6.如权利要求5所述的治疗原发性三叉神经痛的药物组合物,其特征在于所述口服剂型优选为胶囊剂、片剂或丸剂。
7.如权利要求6所述的治疗原发性三叉神经痛的药物组合物,其特征在于所述口服剂型优选为胶囊剂。
8.如权利要求1-4任一所述的治疗原发性三叉神经痛的药物组合物,其特征在于制备方法主要包括如下步骤:(1)取天仙藤、白芥子、白芷,粉碎成平均粒径为10-60μm的颗粒后加入5-10倍量的60%的乙醇水溶液,采用超声波提取,超声波提取完毕,取滤液,减压浓缩成稠膏得提取物A,备用,其中,提取条件包括:超声功率为130-160W,提取温度为30-50℃,提取时间为10-50min;
(2)将灯台莲、水菖蒲、黄连、丝瓜络、向日葵花盘、徐长卿、枸骨叶加水煎煮两次,第一次煎煮1.0-2.0小时,加水量为煎煮药材总重量的6-10倍,第二次煎煮1.0-1.5小时,加水量为煎煮药材总重量的4-7倍,合并煎液,滤过,滤液减压浓缩,加入乙醇至浓度为30%,于-5~5℃冷藏12小时,滤过,滤液回收乙醇,浓缩得稠膏得提取物B,备用:
(3)将胆南星粉碎成120-200目的细粉,优选为200目的细粉,与提取物A、提取物B混合均匀,加入辅料或辅助性成分混匀,按照本领域常规制剂工艺制成药剂学上适宜的剂型,如片剂、胶囊剂、丸剂等。
9.权利要求1-4任一所述的药物组合物在制备治疗原发性三叉神经痛药物中的用途。
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