CN105833149A - 一种用于发作性睡病的中药制剂及其制备方法 - Google Patents

一种用于发作性睡病的中药制剂及其制备方法 Download PDF

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CN105833149A
CN105833149A CN201610309014.0A CN201610309014A CN105833149A CN 105833149 A CN105833149 A CN 105833149A CN 201610309014 A CN201610309014 A CN 201610309014A CN 105833149 A CN105833149 A CN 105833149A
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张立杰
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Abstract

本发明公开了一种用于发作性睡病的中药制剂,它是以太子参、炙黄芪、炒白术、茯苓、当归、桂圆肉、生地黄、石菖蒲、远志、醋龟板、五味子、半夏、陈皮、天竺黄、刺五加、三七、川芎、炒苍术、醋香附、益智仁、天冬、麦冬、麝香、苏合香为原料,属于中药发明领域。根据每味中药的不同特性,以洗净切块预处理后,按比例配制,经特殊方法制作,具有益气健脾、燥湿安神、补肾宁心、养阴生津、活血调经的作用,本发明产品组合及制作方法独特,经临床验证,该药治疗效果显著,治疗周期短,价格低廉,无不良反应和任何毒副作用,具有广阔的市场应用前景。

Description

一种用于发作性睡病的中药制剂及其制备方法
技术领域
本发明涉及一种中药制剂,具体涉及一种用于发作性睡病的中药制剂,本发明还涉及该中药制剂的制备方法。
背景技术
发作性睡病是指白天经常出现睡眠“发作”的一种疾病,并常伴有猝倒症、睡眠瘫痪、生动的幻觉和梦魔等症状。部分患者伴有夜间睡眠紊乱的一种睡眠障碍性疾病。自儿童至老年均可发病,10~25岁起病者居多,常伴随终生,严重影响患者的生存质量,甚至会酿成意外事故而危及生命。
发作性睡病属中医的“嗜睡”、“嗜卧”、“多寐”、“善眠”、“饭醉”、“昏厥”等范畴。多因久居卑湿之地,感受湿浊之邪,束遏阳气;或过食生冷、肥甘之品,脾胃受损,痰湿内生,清阳不升;或思虑劳倦,损伤脾气,运化无权,阳气虚弱;头部外伤,血脉瘀滞,阻塞清窍等而致。
西医多选用利他林、苯丙胺、丙咪嗪、莫达芬尼、氟西汀、文拉法辛等药治疗,虽有一定疗效,但对于儿童患者均属于慎用或禁用药物,其副作用也常使成年患者无法忍受而中止治疗。停药后原发病变反跳加重与继发的副作用,可使患者产生很大的痛苦,治疗过程反反复复,效果不明显,费用高等,给患者的造成较大的心里压力和病痛压力。
发明内容
本发明的目的在于提供一种用于发作性睡病的中药制剂,该中药制剂对于治疗发作性睡病具有治疗效果显著,治愈时间短,价格低廉,无不良反应和副毒作用的特点。
发明人在多年的临床医疗实践中,根据该病症的发展规律,以及中药的配伍原则,并通过大量的临床验证,反复探索总结出用于治疗发作性睡病的中药制剂的新配方。本发明具有治疗效果显著,治愈时间短,价格低廉,无不良反应和副毒作用的特点。
本发明中药物的作用:
其中:
太子参:为石竹科植物孩儿参Pseudostellaria heterophylla(Miq.)Pax ex Pax et Hoffm.的干燥块根。性味:甘、微苦,平。归脾、肺经。功效:益气健脾,生津润肺。用于脾虚体倦,食欲不振,病后虚弱,气阴不足,自汗口渴,肺燥干咳。《陕西中草药》中记载:补气益血,健脾生津。治病后体虚,肺虚咳嗽,脾虚腹泻,小儿虚汗,心悸,口干,不思饮食。
炙黄芪:为豆科植物蒙古黄芪Astragalus membranaceus(Fisch.)Bge.var.mongholicus(Bge.)Hsiao或膜荚黄芪Astragalus membranaceus(Fisch.)Bge.的干燥根炮制品。蜜黄芪:将黄芪片加炼熟的蜂蜜与少许开水,拌匀稍闷,放锅内炒至黄色并不粘手时,取出晾凉(每100斤用炼熟的蜂蜜25斤).性味:甘,温。归肺、脾经。功效:补气固表,利尿托毒,排脓,敛疮生肌。用于气虚乏力,食少便溏,中气下陷,久泻脱肛,便血崩漏,表虚自汗,气虚水肿,痈疽难溃,久溃不敛,血虚痿黄,内热消渴;慢性肾炎蛋白尿,糖尿病。
炒白术:为菊科植物白术Atractylodes macrocephala Koidz.的干燥根茎的炮制品。炒白术:将蜜炙麸皮撒入热锅内,待冒烟时加入白术片,炒至焦黄色、逸出焦香气,取出,筛去蜜炙麸皮。每100kg白术片,用蜜炙麸皮10kg。性味:苦、甘,温。归脾、胃经。功效:健脾益气,燥湿利水,止汗,安胎。用于脾虚食少,腹胀泄泻,痰饮眩悸,水肿,自汗,胎动不安。土白术健脾,和胃,安胎。用于脾虚食少,泄泻便溏,胎动不安。《本经》中记载:主风寒湿痹,死肌,痉,疸,止汗,除热消食。
茯苓:为多孔菌科真菌茯苓Poria cocos(Schw.)Wolf的干燥菌核。性味:甘、淡,平。归心、肺、脾、肾经。功效:利水渗湿,健脾宁心。用于水肿尿少,痰饮眩悸,脾虚食少,便溏泄泻,心神不安,惊悸失眠。《药性论》中记载:开胃,止呕逆,善安心神。主肺痿痰壅。
当归:为伞形科植物当归Angelica sinensis(Oliv.)Diels的干燥根。性味:甘、辛,温。归肝、心、脾经。功效:补血活血,调经止痛,润肠通便。用于血虚萎黄,眩晕心悸,月经不调,经闭痛经,虚寒腹痛,肠燥便秘,风湿痹痛,跌扑损伤,痈疽疮疡。酒当归活血通经。用于经闭痛经,风湿痹痛,跌扑损伤。《日华子本草》中记载:治一切风,一切血,补一切劳,破恶血,养新血及主癥癖。
生地黄:为玄参科植物地黄Rehmannia glutinosa Libosch.的新鲜或干燥块根。生地黄:甘,寒。归心、肝、肾经。功效:清热凉血,养阴,生津。用于热病舌绛烦渴,阴虚内热,骨蒸劳热,内热消渴,吐血,衄血,发斑发疹。
石菖蒲:为天南星科植物石菖蒲Acorus tatarinowii Schott的干燥根茎。性味:辛、苦,温。归心、胃经。功效:化湿开胃,开窍豁痰,醒神益智。用于脘痞不饥,噤口下痢,神昏癫痫,健忘耳聋。《本草备要》中记载:补肝益心,去湿逐风,除痰消积,开胃宽中。疗噤口毒痢,风痹惊痫。
远志:为远志科植物远志Polygala tenuifolia Willd.或卵叶远志Polygala sibirica L.的干燥根。性味:苦、辛、温。归心、肾、肺经。功效:安神益智,祛痰,消肿。用于心肾不交引起的失眠多梦,健忘惊悸,神志恍惚,咳痰不爽,疮疡肿毒,乳房肿痛。《别录》中记载:定心气,止惊悸,益精,去心下膈气、皮肤中热、面目黄。
五味子:为木兰科植物五味子Schisandra chinensis(Turcz.)Baill.或华中五味子Schisandra sphenanthera Rehd.et Wils.的干燥成熟果实。性味:酸、甘,温。归肺,心、肾经。功效:收敛固涩,益气生津,补肾宁心。用于久嗽虚喘,梦遗滑精,遗尿尿频,久泻不止,自汗,盗汗,津伤口渴,短气脉虚,内热消渴,心悸失眠。
半夏:为天南星科植物半夏Pinellia ternata(Thunb.)Breit.的干燥块茎。性味:辛,温;有毒。归脾、胃、肺经。功效:燥湿化痰,降逆止呕,消痞散结。用于痰多咳喘,痰饮眩悸,风痰眩晕,痰厥头痛,呕吐反胃,胸脘痞闷,梅核气;生用外治痈肿痰核。姜半夏多用于降逆止呕。
陈皮:为芸香科植物橘Citrus reticulata Blanco及其栽培变种的干燥成熟果皮。性味:苦、辛,温。归肺、脾经。功效:理气健脾,燥湿化痰。用于胸脘胀满,食少吐泻,咳嗽痰多。
天竺黄:为禾本科植物青皮竹Bambusa textilis McClure或华思劳竹Schizostachyum chinense Rendle等杆内的分泌液干燥后的块状物。性味:甘,寒。归心、肝经。功效:清热豁痰,凉心定惊。用于热病神昏,中风痰迷,小儿痰热惊痫、抽搐、夜啼。
刺五加:为五加科植物刺五加Acanthopanax senticosus(Rupr.et Maxim.)Harms的干燥、根及根茎或茎。性味:辛、微苦,温。归脾、肾、心经。功效:益气健脾,补肾安神。用于脾肾阳虚,体虚乏力,食欲不振,腰膝酸痛,失眠多梦。
三七:为五加科植物三七Panax notoginseng(Burk.)F.H.Chen的干燥根。性味:甘、微苦,温。归肝、胃经。功效:散瘀止血,消肿定痛。用于咯血,吐血,衄血,便血,崩漏,外伤出血,胸腹剌痛,跌扑肿痛。《玉揪药解》中记载:和营止血,通脉行瘀,行瘀血而敛新血。
川芎:为伞形科植物川芎Ligusticum chuanxiong Hort.(或Ligusticum wallichiiFranch.)的干燥根茎。性味:辛,温。归肝、胆、心包经。功效:活血行气,祛风止痛。用于月经不调,经闭痛经,症瘕腹痛,胸胁刺痛,跌扑肿痛,头痛,风湿痹痛。《日华子本草》中记载:治一切风,一切气,一切劳损,一切血,补五劳,壮筋骨,调众脉,破癥结宿血,养新血,长肉,鼻洪,吐血及溺血,痔瘘,脑痈发背,瘰疬瘿赘,疮疥,及排脓消瘀血。
炒苍术:为菊科植物茅苍术Atractylodes lancea(Thunb.)DC.或北苍术Atractylodes chinensis(DC.)Koidz.的干燥根茎的炮制品。炒苍术:取苍术片,用米泔水喷洒湿润,置锅内用文火炒至微黄色;或取拣净的苍术,用米泔水浸泡后捞出,置笼屉内加热蒸透,取出,切片,干燥即得。性味:辛、苦,温。归脾、胃、肝经。功效:燥湿健脾,祛风散寒,明目。用于脘腹胀满,泄泻,水肿,脚气痿躄,风湿痹痛,风寒感冒,夜盲。《玉楸药解》中记载:燥土利水,泄饮消痰,行瘀,开郁,去漏,化癖,除症,理吞酸去腐,辟山川瘴疠,回筋骨之痿软,清溲溺之混浊。
醋香附:为莎草科植物莎草Cyperus rotundus L.的干燥根茎的炮制品。取净香附粒,加醋拌匀,闷一宿,置锅内炒至微黄色,取出晾干。(每香附粒100斤,用醋20斤)香附炭。性味:辛、微苦、微甘,平。归肝、脾、三焦经。功效:行气解郁,调经止痛。用于肝郁气滞,胸、胁、脘腹胀痛,消化不良,胸脘痞闷,寒疝腹痛,乳房胀痛,月经不调,经闭痛经。《纲目》中记载:散时气寒疫,利三焦,解六郁,消饮食积聚,痰饮痞满,跗肿,腹胀,脚气,止心腹、肢体、头、目、齿、耳诸痛,痈疽疮疡,吐血,下血,尿血,妇人崩漏带下,月候不调,胎前产后百病。
益智仁:为姜科植物益智的果实。性味:辛,温。入脾,肾经。功效:温脾,暖肾,固气,涩精。治冷气腹痛,中寒吐泻,多唾,遗精,小便余沥,夜多小便。《本草拾遗》中记载:治遗精虚漏,小便余沥,益气安神,补不足,利三焦,调诸气,夜多小便者,取二十四枚碎,入盐同煎服。
天冬:为百合科植物天门冬Asparagus cochinchinensis(Lour.)Merr.的干燥块根。性味:甘、苦,寒。归肺、肾经。功能主治:养阴润燥,清肺生津。用于肺燥干咳,顿咳痰黏,咽干口渴,肠燥便秘。
麦冬:为百合科植物麦冬(沿阶草)Ophiopogon japonicus(Thunb.)Ker-Gawl.的干燥块根。性味:甘,微苦,微寒。归心、肺、胃经。功能主治:养阴生津,润肺清心。用于肺燥干咳。虚痨咳嗽,津伤口渴,心烦失眠,内热消渴,肠燥便秘;咽白喉。
麝香:为鹿科动物林麝Moschus berezovskii Flerov、马麝Moschussifanicus Przewalski或原麝Moschus moschiferus Linnaeus成熟雄体香囊中的干燥分泌物。性味:辛,温。归心、脾经。功效:开窍醒神,活血通经,消肿止痛。用于热病神昏,中风痰厥,气郁暴厥,中恶昏迷,经闭,癓瘕,难产死胎,心腹暴痛,痈肿瘰疬,咽喉肿痛,跌扑伤痛,痹痛麻木。《别录》中记载:疗中恶,心腹暴痛,胀急痞满,风毒,妇人难产,堕胎,去面鼠,目中肤翳。
苏合香:为金缕梅科枫香属植物苏合香树Liquidambar orientalis Mill.的树干渗出的香树脂,经加工精制而成。性味:辛,温。归心、脾经。功效:开窃,辟秽,止痛。用于中风痰厥,猝然昏倒,胸腹冷痛,惊痫。《本草备要》中记载:走窜,通窍开郁,辟一切不正之气。
龙眼肉:为无患子科龙眼属植物龙眼Dimocarpus longan Lour.的假种皮。性味:甘,温。归心、脾经。功效:补益心脾,养血安神。用于气血不足,心悸怔忡,健忘失眠,血虚萎黄。《滇南本草》中记载:养血安神,长智敛汗,开胃益脾。
醋龟板:为龟科动物乌龟Chinemys reevesii(Gray)的背甲及腹甲的炮制品。醋龟甲:取净龟甲,照烫法(附录II D)用沙子炒至表面淡黄色,取出,醋淬,干燥。用时捣碎。每100kg龟甲,用醋20kg。性味:咸、甘,微寒。归肝、肾、心经。功效:滋阴潜阳,益肾强骨,养血补心。用于阴虚潮热,骨蒸盗汗,头晕目眩,虚风内动,筋骨痿软,心虚健忘。
本发明的方解是:太子参益气健脾、生津润肺,炒白术健脾益气、燥湿利水,茯苓利水渗湿、健脾宁心,桂圆肉补益心脾、养血安神,陈皮理气健脾、燥湿化痰,刺五加益气健脾、补肾安神,炒苍术燥湿健脾、祛风散寒,以上七味药作为方中君药,均归脾经,具有益气健脾、燥湿安神的作用。中医学认为,本病是病的形成多因久居卑湿之地,感受湿浊之邪,束遏阳气或过食生冷、肥甘之品,脾胃受损,痰湿内生,清阳不升;或思虑劳倦,损伤脾气,运化无权,阳气虚弱;头部外伤,血脉瘀滞,阻塞清窍等而引发本病。所以益气健脾、燥湿安神是治疗发作性睡病的基础,以上七味药均为君药,首先从根本上益气健脾、燥湿安神,使病症得到根本的控制。炙黄芪补气固表、敛疮生肌,生地黄清热凉血、养阴生津,石菖蒲化湿开胃、醒神益智,远志安神益智、祛痰消肿,醋龟板滋阴潜阳、益肾补心,五味子益气生津、补肾宁心,天竺黄清热豁痰、凉心定惊,益智仁温脾暖肾、固气涩精,天冬养阴润燥、清肺生津,麦冬养阴生津、润肺清心,麝香开窍醒神、活血通经,以上十一味药为方中臣药,中医认为肾为“先天之本”,脾胃为“后天之本”,所以肾与脾胃是相互资助、相互依存的。肾的精气有赖于水谷精微的培育和充养,才能不断充盈和成熟,而脾、胃转化水谷精微则必须借助于肾阳的温煦。故有“非精血无以立形体之基,非水谷无以成形体之壮”之说法。故方中臣药,一方面辅助君药益气健脾、燥湿安神的功效;另一方面作为臣药具有补肾宁心、养阴生津的功效。当归补血活血、润肠通便,半夏燥湿化痰、消痞散结,天竺黄清热豁痰、凉心定惊,三七散瘀止血、消肿定痛,川芎活血行气、祛风止痛,醋香附行气解郁、调经止痛,苏合香开窃辟秽,以上七味药作为佐药,从病理上治疗引起发作性睡病的诱因,作为佐药既能促进君臣二药的益气健脾、燥湿安神的功效,又能反佐君臣二药促进机体补肾宁心、养阴生津的作用。同时作为具有活血调经的功效。生甘草作为方中使药,具有调和诸药、调和药味的作用,此方诸药合用,君臣协力,臣佐共辅,具有益气健脾、燥湿安神、补肾宁心、养阴生津、活血调经的功效,能够有效治疗发作性睡病。
本发明另一个重要特点是该中药制剂含有丰富的营养成分,富含氨基酸有17种以上,其中人体必需氨基酸有苏氨酸、缬氨酸、蛋氨酸、异亮氨酸、亮氨酸、赖氨酸和苯丙氨酸,含有人体必需的微量元素有铁、铬、铜、硼、锰、锶、和锌,另含钙、钾、镁、磷几种人体宏量元素。以上营养成分都是人体必需物质,能有效增强人体免疫力。
本发明药物原料用量是经发明人进行大量摸索总结得出的,各原料用量为在下述重量份范围都具有较好的疗效:太子参13-17g、炙黄芪28-32g、炒白术22-26g、茯苓13-17g、当归13-17g、桂圆肉13-17g、生地黄16-20g、石菖蒲18-22g、远志18-22g、醋龟板13-17g、五味子10-14g、半夏8-12g、陈皮13-17g、天竺黄10-14g、刺五加13-17g三七10-14g、川芎13-17g、炒苍术13-17g、醋香附10-14g、益智仁18-22g、天冬10-14g、麦冬10-14g、麝香0.03-0.07g、苏合香0.3-0.7g。
其中优选为:太子参15g、炙黄芪30g、炒白术24g、茯苓15g、当归15g、桂圆肉15g、生地黄18g、石菖蒲20g、远志20g、醋龟板15g、五味子12g、半夏10g、陈皮15g、天竺黄12g、刺五加15g三七12g、川芎15g、炒苍术15g、醋香附12g、益智仁20g、天冬12g、麦冬12g、麝香0.05g、苏合香0.5g。
一种用于发作性睡病的中药制剂的制备方法如下:
步骤一:按本发明重量份配比,取麝香、三七、天竺黄、苏合香,粉碎,过200目筛,备用;
步骤二:按本发明重量份配比,取半夏药材置于砂锅中,加入3倍体积的水,武火熬煮20-30分钟,转文火熬煮30-40分钟,过滤滤液,反复熬煮三次,合并三次滤液,备用;
步骤三:按本发明重量份配比,取炙黄芪、炒白术、醋龟板、炒苍术、醋香附,冷却,粉碎磨粉,过200目筛,备用;
步骤四:按本发明重量配比,取太子参、茯苓、生地黄、石菖蒲、远志、刺五加、天冬、麦冬药材置于砂锅中,加入8倍体积的水,武火熬煮20-30分钟后,加入当归、陈皮、川芎及分别用纱布包扎好的五味子、桂圆肉、益智仁,武火熬煮10-20分钟,转文火熬煮30~40分钟得滤液,反复熬煮三次合并所得滤液,备用;
步骤五:合并步骤二、步骤四所得滤液并并趁热倒入盛有步骤一所得粉末,混合,搅匀,后与步骤三所得粉末混合,搅匀,将药汤进行浓缩加乙醇,放置沉淀,过滤,弃沉淀,滤液回收乙醇,将所得药液浓缩为75℃环境下相对密度1.15~1.20的稠膏,将稠膏风干粉碎,加入蜂蜜、防腐剂、润湿剂等,进行捶打、搓条、成丸,晾干,分装入袋,每袋含有效成分0.1g,既得本发明所述的治疗发作性睡病的蜜丸剂。
本发明使用方法:取蜜丸剂,饭后一小时内服用,每次一袋,每天三次。
本发明药物具有益气健脾、燥湿安神、补肾宁心、养阴生津、活血调经的作用,且止痛效果好,价格低廉,无毒副作用,使用方便,该中药制剂采用的方式治疗可以减少西药对患者身体的伤害,减轻患者的病痛,据对临床240例患者观察统计,使用本发明药物一个疗程总有效率82.5%,两个疗程总有效率95%。
具体实施方式
实施例一:太子参15g、炙黄芪30g、炒白术24g、茯苓15g、当归15g、桂圆肉15g、生地黄18g、石菖蒲20g、远志20g、醋龟板15g、五味子12g、半夏10g、陈皮15g、天竺黄12g、刺五加15g三七12g、川芎15g、炒苍术15g、醋香附12g、益智仁20g、天冬12g、麦冬12g、麝香0.05g、苏合香0.5g。
实施例二:太子参14g、炙黄芪31g、炒白术23g、茯苓16g、当归15g、桂圆肉15g、生地黄19g、石菖蒲21g、远志21g、醋龟板14g、五味子12g、半夏10g、陈皮16g、天竺黄13g、刺五加16g三七13g、川芎14g、炒苍术14g、醋香附12g、益智仁21g、天冬13g、麦冬13g、麝香0.04g、苏合香0.4g。
实施例三:太子参16g、炙黄芪31g、炒白术23g、茯苓13g、当归15g、桂圆肉15g、生地黄17g、石菖蒲20g、远志21g、醋龟板14g、五味子11g、半夏11g、陈皮16g、天竺黄12g、刺五加16g三七11g、川芎14g、炒苍术14g、醋香附11g、益智仁21g、天冬13g、麦冬13g、麝香0.06g、苏合香0.4g。
下面是患者使用本发明药物的临床统计资料:
一、一般资料
收治门诊患者240例,将患者随机分为观察组和对照组各30例,其中男性200例,女性40例,男女比例5∶1,最大年龄24岁,最小年龄8岁,病程几个月到几年不等。两组患者年龄、性别、病程等各项基本资料基本相同,差异无统计学意义(P>0.05)。
二、诊断标准
1、多见于男性青少年。
2、症状缓慢发展或相对稳定。
3、可能与遗传有关。少数可有颅脑外伤、脑炎病史。
4、表现发作性难以抗拒的睡眠,如谈话、行走操作机器或车船等情况下均可入睡。发作与环境无明显关系,易受外界刺激而清醒。
5、可伴发猝倒症、睡眠麻痹、催眠幻觉、肥胖或低血压症。
6、神经系统检查正常。
三、治疗方法:
1、观察组按照本发明药物实施例一,称取原料药按发明实施方法治疗,取汤剂,饭后一小时内服用,每次一袋,每天三次。15天为一个疗程。
四、疗效评定标准:
1、治愈:发作性睡眠与主要伴发症状消失。
2、好转:发作性睡眠与主要伴发症状减少。
3、无效:症状没有减少甚至更加严重。
五、治疗结果统计:
对照组结果统计
使用该中药制剂两个疗程两组患者的疗效对比情况
组别 例数 治愈[n(%)] 好转[n(%)] 无效[n(%)] 总有效率(%)
观察组 120 81(67.5) 33(27.5) 6(5) 95
对照组 120 60(50) 40(33.3) 20(16.7) 83.3
其中:总有效率=治愈率+好转率
通过对比两组患者的治疗总有效率可以发现观察组明显高于对照组,由此说明,本发明中药在治疗发作性睡病上具有良好的临床效果,能有效提高治疗的治愈率,效果显著,价格低廉,无不良反应和任何毒副作用,具有广阔的市场应用前景。
典型病例及疗效:
病例一、患者王某,女,16岁,青岛市人,2010年1月20日来我处就诊。患者最近一年来整日感觉困倦,时时欲睡,每次睡约半小时,醒后感觉疲乏无力,精神欠佳,伴有头晕症状,表现发作性难以抗拒的睡眠,易受外界刺激而清醒。偶尔伴发猝倒症、催眠幻觉,而医院检查神经系统检查正常,诊断为发作性睡病。遂来我处治疗,采用本发明实施例一中所制制剂,以及所选的制备方法,用药15天后,症状消失,彻底治愈,电话随访半年未复发。
病例二、患者李某,男,12岁,山东临沂人。2010年5月14日来我处就诊,经诊断症状如下:上课精神不振、时时欲睡,表现发作性难以抗拒的睡眠,老师谈话情况下站立入睡,易受外界刺激而清醒,偶尔在会出现伴发猝倒症,而神经系统检查正常,确诊为发作性睡病。采用本发明实施例一中所制制剂,以及所选的制备方法,用药7天后,症状减退,恢复良好,继续用药5天,彻底治愈,电话随访半年未复发。

Claims (4)

1.一种用于发作性睡病的中药制剂,其特征在于,该中药制剂是由以下重量份的药物制成:太子参13-17g、炙黄芪28-32g、炒白术22-26g、茯苓13-17g、当归13-17g、桂圆肉13-17g、生地黄16-20g、石菖蒲18-22g、远志18-22g、醋龟板13-17g、五味子10-14g、半夏8-12g、陈皮13-17g、天竺黄10-14g、刺五加13-17g三七10-14g、川芎13-17g、炒苍术13-17g、醋香附10-14g、益智仁18-22g、天冬10-14g、麦冬10-14g、麝香0.03-0.07g、苏合香0.3-0.7g。
2.根据权利要求1所述的用于发作性睡病的中药制剂,其特征在于,由以下重量份的药物制成:太子参15g、炙黄芪30g、炒白术24g、茯苓15g、当归15g、桂圆肉15g、生地黄18g、石菖蒲20g、远志20g、醋龟板15g、五味子12g、半夏10g、陈皮15g、天竺黄12g、刺五加15g 三七12g、川芎15g、炒苍术15g、醋香附12g、益智仁20g、天冬12g、麦冬12g、麝香0.05g、苏合香0.5g。
3.根据权利要求1或2所述的用于发作性睡病的中药制剂,其特征在于:所述中药制剂为蜜丸剂。
4.一种用于发作性睡病的中药制剂的制备方法,其特征在于,制备方法如下:步骤一:按本发明重量份配比,取麝香、三七、天竺黄、苏合香,粉碎,过200目筛,备用;步骤二:按本发明重量份配比,取半夏药材置于砂锅中,加入3倍体积的水,武火熬煮20-30分钟,转文火熬煮30-40分钟,过滤滤液,反复熬煮三次,合并三次滤液,备用;步骤三:按本发明重量份配比,取炙黄芪、炒白术、醋龟板、炒苍术、醋香附,冷却,粉碎磨粉,过200目筛,备用;步骤四:按本发明重量配比,取太子参、茯苓、生地黄、石菖蒲、远志、刺五加、天冬、麦冬药材置于砂锅中,加入8倍体积的水,武火熬煮20-30分钟后,加入当归、陈皮、川芎及分别用纱布包扎好的五味子、益智仁、桂圆肉,武火熬煮10-20分钟,转文火熬煮30~40分钟得滤液,反复熬煮三次合并所得滤液,备用;步骤五:合并步骤二、步骤四所得滤液并并趁热倒入盛有步骤一所得粉末,混合,搅匀,后与步骤三所得粉末混合,搅匀,将药汤进行浓缩加乙醇,放置沉淀,过滤,弃沉淀,滤液回收乙醇,将所得药液浓缩为75℃环境下相对密度1.15~1.20的稠膏,将稠膏风干粉碎,加入蜂蜜、防腐剂、润湿剂等,进行捶打、搓条、成丸,晾干,分装入袋,每袋含有效成分0.1g,既得本发明所述的治疗发作性睡病的蜜丸剂。
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