CN102091228A - 一种治疗失眠的药物及其制备方法 - Google Patents
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Abstract
本发明“一种治疗失眠的药物及其制备方法”,涉及中药组合物。是灰树花(Griflolafrondosa)母种和黑木耳母种以以下中药原料药混合物的水提取液为培养基的发酵产物;所述中药原料药混合物为:当归1~3份、麦冬1~3份、天冬1~3份、炒酸枣仁5~15份、柏子仁5~15份、远志5~15份、生地3~8份、苦参5~15份、丹参5~15份、元参5~15份、黄岑5~15份、桔梗5~15份、五味子5~15份。是一种适合大多数失眠患者、兼具补益与治疗双重功效、无毒副作用、针对失眠的生理因素、老少皆宜的治疗失眠的药物。
Description
技术领域
本发明涉及中药组合物,特别是一种治疗失眠的药物及其制备方法。
背景技术
失眠,又称入睡和维持睡眠障碍(DlMS),临床以不易入睡,睡后易醒,醒后不能再寐,时寐时醒,或彻夜不寐为其证候特点,并常伴有日间精神不振,反应迟钝,体倦乏力,甚则心烦懊恼,严重影响身心健康及工作,学习和生活。历代医家认为失眠的病因病机以七情内伤为主要病因,其涉及的脏腑不外心、脾、肝、胆、肾,其病机总属营卫失和,阴阳失调为病之本,或阴虚不能纳阳,或阳盛不得入阴。正如《灵枢·大惑论》所云:“卫气不得人于阴,常留于阳。留于阳则阳气满,阳气满则阳跷盛;不得入于阴则阴气虚,故目不瞑矣。”《灵枢·邪客篇》指出:“今厥气客于五藏六府,则卫气独行于外,行于阳,不得入于阴。行于阳则阳气盛,阳气盛则阳跷陷,不得入于阴,阴虚,故不瞑。”
可见,人的正常睡眠是阴阳之气自然而有规律地转化的结果,如果这种规律一旦被破坏,就可以导致不寐的发生,而这种规律被破坏的原因主要由于外邪如火、热、气、血之壅塞,干扰卫气的正常运行,内伤情志使五脏气机失常、气血不和及阴阳失调而致失眠,病理因素多为气、血、痰、瘀、火、郁、湿、食等,故七情所伤之失眠尤为重要。张景岳在《景岳全书·卷十八·不寐》中说:“盖寐本乎阴,巾其主也,神安则寐,神不安则不寐。”而这种神当是指心神,即人体生理活动和心理活动的主宰者。心是人体情志的发生之处和主宰者。心主神志,肝主情志,脾志为思,若情志不舒,思虑过度,不仅影响肝之疏泄,出现肝郁气滞,化火扰神,而且进一步耗伤心血,损伤脾运,最后发展还会出现耗尽真阴真元,心肾失交神志不宁,致使五脏俱虚,病情虚实胶结,缠绵难愈。
失眠按症状周期分为短暂性失眠,短期失眠和长期失眠。大部分的人在经历到压力、刺激、兴奋、焦虑、生病时、处于高海拔的地方或者睡眠规律改变时(如时差;轮班的工作等)都会有短暂性失眠障碍。这类失眠一般会随着事件的消失或时间的拉长而改善,但是短暂性失眠如处理不当部分人会导致慢性失眠即长期失眠。而慢性失眠分为原发性失眠和继发性失眠。原发性失眠是一种原因不明的、长期或终生存在的频繁的睡眠中断、短睡伴日间疲劳、紧张、压抑和困倦,一般认为除了内在原因和环境干扰的因素之外,部分患者可能有失眠的家族史,大多渐渐发展成慢性精神性心理失眠。继发性失眠:由疼痛、咳嗽、呼吸困难、夜尿多、心绞痛和其他的躯体疲劳和症状引起的失眠,许多新陈代谢疾病可以引起生物钟的改变,导致继发性失眠。
慢性失眠和严重的短期失眠都会严重影响人的正常生活,使人体内在的失衡进一步从而形成恶性循环,必须通过治疗或者药物干预才能使患者从失眠的困扰中走出来,否则由失眠会引起脑神经损伤,记忆力衰退,免疫力下降,疾病尤其是恶性疾病发生几率大大提高;在精神和心理上则会引起烦躁、抑郁、自卑、自闭等精神疾病,且容易造成失眠与其并发症互相影响愈演愈烈情况,增加病情的复杂性和治疗难度。
中医治疗失眠,通常将失眠分为以下五种类型对症治疗:
一:肝郁化火:多由恼怒烦闷而生,表现为少寐,急躁易怒、目赤口苦、大便干结、舌红苔黄、脉弦而数。方以龙胆泻肝汤为基础。
二:痰热内扰:常由饮食不节,暴饮暴食、恣食肥甘生冷、或嗜酒成癖,导致肠胃受热,痰热上扰。表现为不寐、头重、胸闷、心烦、喛气、吞酸、不思饮食,苔黄腻,脉滑数。方以温胆汤为基础。
三:阴虚火旺:多因身体虚精亏,纵欲过度,遗精,使肾阴耗竭,心火独亢,表现为心烦不寐,五心烦热,耳呜健忘,舌红,脉细数。方以朱砂安神丸、二至丸为基础。
四:心脾两虚:由于年迈体虚,劳心伤神或久病大病之后,引起气虚血亏,表现为多梦易醒,头晕目眩,神疲乏力,面黄色少华,舌淡苔溥,脉细弱。方以归脾汤为基础。
五:心胆气虚:由于突然受惊,或耳闻巨响,目暏异物,或涉险临危,表现为噩梦惊扰,夜寐易醒,胆怯心悸,遇事易惊,舌淡脉细弦。方以安神定志丸为基础。
总结以上五种类型的失眠,肝肾阴虚、肾气肾精亏虚是其基本病机。大量的实验和临床研究表明,肾虚者大多脑功能下降,导致大脑神经细胞减少,递质含量及递质受体数量均下降,内分泌功能紊乱,免疫功能下降,自身免疫和变态反应增加,而抗自由基损伤的物质如SOD含量下降。这些变化说明肾虚是失眠的重要病因,不管病情如何变化,肾虚始终贯穿失眠的整个病程,是其最本质的特征。
虽然有诸多方剂治疗不同类型的失眠,但失眠患者往往不把失眠当成病去专门请医生对症诊治,最多是到药店凭一己猜测的病因去买自认为合适的中成药,甚至助眠的西药,服药后常常无效或者要承受药物对脑神经造成的副作用,进而丧失治疗失眠的信心,造成心理性失眠。目前尚未见到一种适合大多数失眠患者,兼具补益与治疗双重功效,无毒副作用,从失眠的最本质原因着手,老少皆宜的中成药。
发明内容
本发明根据上述领域的空白,提供一种适合大多数失眠患者、兼具补益与治疗双重功效、无毒副作用、针对失眠患者的生理因素、老少皆宜的治疗失眠的药物。
一种治疗失眠的药物,是灰树花(Griflola frondosa)母种和黑木耳母种以以下中药原料药混合物的水提取液为培养基的发酵产物;所述中药原料药混合物为:当归1~3份、麦冬1~3份、天冬1~3份、炒酸枣仁5~15份、柏子仁5~15份、远志5~15份、生地3~8份、苦参5~15份、丹参5~15份、元参5~15份、黄岑5~15份、桔梗5~15份、五味子5~15份。
所述中药原料药混合物为:当归2份、麦冬2份、天冬2份、炒酸枣仁10份、柏子仁10份、远志10份、生地5份、苦参10份、丹参10份、元参10份、黄岑10份、桔梗10份、五味子10份。
所述灰树花母种指有增殖活力的灰树花菌丝,所述黑木耳母种指黑木耳菌丝。
以上述药物为有效成分的药剂。
上述治疗失眠的药物的制备方法,其特征在于:将灰树花母种与黑木耳母种接种到所述中药原料药混合物的水提取液中发酵。
所述发酵步骤为:
(1)制备中药原料药混合物的水提取液:在所述中药原料药的混合物中加饮用水煎煮提取两次,每次过滤取汁,后一次弃渣,合并两次所取的水提取物,所述水提取物中原料药的质量百分比为10~20%;
(2)接种:对水提取物进行常压灭活,待冷却至常温,接种灰树花菌丝母种和黑木耳菌丝母种;
(3)深层发酵:发酵时间为72~114小时。
所述常压灭活指常压下水蒸12小时。
所述深层发酵72~114小时后,对发酵产物进行放罐、浓缩、焙干、过筛最后得粉状制品。
本发明提供的治疗失眠的药物,是灰树花与黑木耳在中药提取液中进行深层发酵获得的产物,经发酵后中药原料药的毒副作用尽除,并扩大了中药原料药中有效成分的药效,与灰树花及黑木耳的有效成分配伍,具有滋补肝肾,益精健脑,安眠补身,滋阴潜阳使患者阴阳平衡,免疫力提高,修复脑神经的损伤,从而摆脱失眠。药方成分全面,兼顾补益与治疗的功效,表里兼治。据门诊治疗统计,治愈率在98%以上,治愈表现为:患者精神面貌大为改善,生物钟节律明显,按时入睡,睡眠深层且少梦,每晚睡眠在7小时左右次日就精神抖擞无倦态,对药物无依赖。以下逐一简介本发明的药物的成分及其作用:
灰树花,又叫舞茸,学名:Grifola frondosa,英文名:Maitake,原产于日本北部山区,是一种药食两用菇类,味道佳口感好且有传承药效。它有抑制高血压和肥胖症的功效;由于富含铁、铜和维他命C,它能预防贫血、坏血病、白癜风,防止动脉硬化和脑血栓的发生;它的硒和铬含量较高,有保护肝脏、胰脏,预防肝硬化和糖尿病的作用;硒含量高使其还具有防治克山病、大骨节病和某些心脏病的功能;它兼含钙和维生素D,两者配合,能有效地防治佝偻病;较高的锌含量有利大脑发育、保持视觉敏锐,促进伤口愈合;高含量的维生素E和硒配合,使之能抗衰老、增强记忆力和灵敏度。灰树花还是引人注目的抗癌药源,一方面,较高的硒含量有抗御癌肿的作用,尤其是所含灰 树花多糖(Grifolan),以β-葡聚糖(glucan)为主,其中抗癌活性最强,带6条支链的β-(1,3)-葡聚糖占相当大的比重,据说比已经面市的香菇多糖(Lentinan,日本的PSK,)、云 芝多糖(上海的PSP)等有更强的抗癌能力;同时它又是极好的免疫调节剂。作为中药,灰树花和猪苓等效,可治小便不利、水肿、脚气、肝硬化腹水及糖尿病等。在本发明的药物中,主要起着补益、提高失眠患者自己免疫力的作用,唤醒患者自身的生物节律。
柏子仁:为柏科植物侧柏Biotaorientalis(L.)End1.的种仁。含有脂肪泊约14%,多为不饱和脂肪酸组成,还含有少量挥发油,皂甙、蛋白质、钙、磷、铁多种维生素等。柏子仁性平味甘。具养心安神、润肠通便的功效。主治惊悸、失眠、遗精、盗汗、便秘等症。在本发明的药物中,对患者有治劳欲过度、心血亏损、精神恍惚、夜多怪梦、怔仲惊悸,健忘遗泄,宁心定志,补肾滋阴的作用,助眠和提高睡眠质量。
远志(Radix Polygalae),为常用中药,最早记载于《神农本草经》,列为上品,并被视为养命要药,来源于远志科植物远志Polygala tenuifolia Willd.和卵叶远志P.sibirica L.的干燥根。性温,味苦、辛,具有安神益智、祛痰、消肿的功能,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。在本发明中,与当归、生地配伍止阴虚;与麦冬、丹参、配伍补心、肺。
生地,玄参科多年生草本植物地黄Rehmannia glutinosa Libosch.的新鲜或干燥的块根,有清热凉血、益阴生津之功效。李时珍对生地黄的评价是:“服之百日面如桃花,三年轻身不老”。性味与归经:生地黄甘,寒。归心、肝、肾经。功能与主治: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。《本 草衍义》:凉血补血,补益肾水真阴不足。
苦参,中药苦参为多年生落叶亚灌木植物苦参的根,味苦;性寒 归经:肝;肾;大肠;小肠经;膀胱;心经;膀胱经,含有多种种类的生物碱中,且以苦参碱(Matrine)、氧化苦参碱(Oxymatrine)为主。有实验表明,苦参总碱50-100mg/kg能明显抑制小鼠的自由活动;400mg/kg对小鼠被动活动明显抑制;100-200mg/kg能抑制孤独小鼠的欧斗攻击行为;苦参总碱25-40mg/kg与冬眠灵(5mg/kg)合用,可致小鼠翻正反射消失,100-200mg/kg苦参总碱能明显加强0.5mg/kg利血平对小鼠自发活动的抑制作用;苦参总碱50-200mg/kg与腹腔注射阈下剂量的戊巴比妥钠20-25mg/kg合用,可致小鼠入睡;分别与硫喷妥钠(腹腔注射,40mg/kg)、水合氯醛(腹腔注射,200mg/kg)合用,能显着加强其中枢抑制作用。亦能明显对抗中枢兴奋剂苯丙胺(腹腔注射,4-6mg/kg)及咖啡因(50mg/kg)所致的精神运动性兴奋。在本发明的药物中,主要起到镇定助眠的作用。
丹参,本品为双子叶植物唇形科Labiatae鼠尾草属植物丹参(Salvia miltiorrhiza Bge.)的干燥根及根茎。苦,微寒。归心、肝经。活血调经,祛瘀止痛,凉血消痈,清心除烦,养血安神。与酸枣仁配伍用于心悸怔忡、失眠,与远志配伍补心。
元参:为玄参科多年生草本植物玄参的根,主产于浙江、四川、湖北等地。味苦咸。性微寒。无毒。主治:主腹中寒热积聚。女子产乳余疾。补肾气。令人明目。(本经)暴中风伤寒。本品质润多液,能养阴生津,用于热病伤津,常配麦冬、生地等同用,调节患者阴阳平衡。
黄芩,为唇形科植物黄芩(Scutellaria baicalensis Georgi),以根入药,性味与归经:苦,寒。归肺、胆、脾、大肠、小肠经。用于湿温、暑温胸闷呕恶,湿热痞满,泻痢,黄疸,肺热咳嗽,高热烦渴,血热吐衄,痈肿疮毒,胎动不安。本发明中采用其降压、利尿,祛湿的作用,调理脾的功能,助眠、镇静。
桔梗,为双子叶植物桔梗科桔梗(Platycodon grandiflorum(Jacq.)A.DC.)的根。味苦、辛,性微温。入肺经。能祛痰止咳,并有宣肺、排脓作用。药理作用研究表明,桔梗煎剂以1g/kg给麻醉狗灌胃,可使呼吸道分泌物增加;桔梗皂甙粗品具有镇静、镇痛及解热等中枢抑制作用。本发明的药物中借其对中枢神经的抑制作用以助眠。
五味子,为木兰科植物五味子(Schisandra chinensis(Turcz.)Baill.)干燥成熟果实,温;酸、甘;归肺、心、肾经。功能与主治: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。顾名思义是一种具有辛、甘、酸、苦、咸五种药性的果实,这种五味俱全、五行相生的果实,能对人体五脏-心、肝、脾、肺及肾发挥平衡作用。是兼具精、气、神三大补益的少数药材之一,能益气强肝、增进细胞排除废物的效率、供应更多氧气、营造和运用能量、提高记忆力及性持久力。在本发明的药物中,起着关键的补益和调节平衡的作用。除此之外,五味子素有广泛的中枢抑制作用和安定作用。五味子醇提取物5~10mg/kg灌胃可减少小鼠自发活动,及协同戊巴比妥钠对小鼠的睡眠作用,对抗苯丙胺引起的小鼠兴奋,对抗咖啡因、烟碱引起的小鼠惊厥。五味子素(五味子醇甲)10~100mg/kg腹腔注射,随剂量的增加而减少小鼠自发活动,10mg/kg腹腔注射对抗咖啡因、苯丙胺引起的小鼠兴奋;60~120mg/kg腹腔注射明显延长小鼠巴比妥钠及戊巴比妥钠引起的小鼠睡眠时间;对抗电休克、戊四唑等引起的惊厥。
酸枣仁,为鼠李科植物酸枣(Ziziphus psinosa Hu)的种子,性味:甘,平;入心、脾、肝、胆经。《别录》:主烦心不得眠,脐上下痛,血转久泄,虚汗烦渴,补中,益肝气,坚筋骨,助阴气,令人肥健。⑥《本草汇言》:敛气安神,荣筋养髓,和胃运脾。⑦《本草再新》:平肝理气,润肺养阴,温中利湿,敛气止汗,益志定呵,聪耳明目。
当归,伞形科植物当归(Angelica sinensis(Oliv.)Diels)的根,性温,昧甘、辛。归肝、心、脾经。主治: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。而在本药物在,主要采用其护心的功效,在1989年朱玉真等对当归的水溶成分中的当归总酸进行了抗心律失常作用的研究,结果表明当归总酸对氯仿一肾上腺素、乌头碱、氯化钡等诱发的动物药物型心律失常有明显的保护作用,其抗心律失常作用可能与降低心脏兴奋性、延长心肌不应期有关;据张培棪报道,当归中性油对实验心肌缺血亦有明显保护作用。
麦冬,为百合科植物麦冬(Ophiopogon japonicus(L.f)Ker-Gawl.)的干燥块根。性味与归经:甘、微苦,微寒。归心、肺、胃经。功能与主治:养阴生津,润肺清心。用于肺燥干咳,阴虚痨嗽,喉痹咽痛,津伤口渴,内热消渴,心烦失眠,肠燥便秘。
天冬,为百合科植物天门冬(Asparaguscochinchinensis(Lour.)Merr.)的块根,又名天门冬。性寒,味甘,微苦。具有养阴清热,润肺滋肾的功效。
本发明还提供了上述药物的制备方法。主要是先将配伍好的原料药进行煎煮提取药用成分,去药渣后在提取液中接种适量的黑木耳母种和灰树花菌丝母种,然后在适宜温度下深层发酵72~114小时。
具体实施方式
实施例1.药物制备
步骤1.中药水提取物制备
中药原料及其重量份:当归2份、麦冬2份、天冬2份、炒酸枣仁10份、柏子仁10份、远志10份、生地5份、苦参10份、丹参10份、元参10份、黄岑10份、桔梗10份、五味子10份。
按上述原料药组分一共称取30kg,至于置于130kg饮用水中,大火煮沸,并用小火再煎煮两小时,过滤取汁约得到65~80kg,留药渣,并再注入130kg饮用水,大火煮沸后小火再煎煮约三小时,过滤取汁约得到60~75kg,弃渣,将两次药汁合并,使总计重量约150kg药物水提取液。
步骤2.制备黑木耳菌丝母种液及灰树花菌丝母种液
材料:黑木耳菌种ACCC 50438:中国农业微生物菌种保藏管理中心(Agricultural Culture Collection of China英文缩写ACCC),保藏编号50438;
灰树花菌种ACCC50887:中国农业微生物菌种保藏管理中心(Agricultural Culture Collection of China英文缩写ACCC),保藏编号ACCC50887。
上述黑木耳母种和灰树花母种申请人实验室亦有保存,并制备成试管菌丝母种,自申请日起二十年可向公众发放用于实验研究。用于本发明的黑木耳菌丝母种和灰树花菌丝母种也可以是商购途径得到,没有特别要求。
材料:
1.步骤1的药物水提取液
2.营养琼脂培养基;(上海中药昆虫生物科技开发有限公司康乐培养基厂)
3.酵母浸膏;(北京双旋微生物培养基制品厂)
4.磷酸氢二钾;(广东汕头西陇化工厂)
5.硫酸锌(分析纯);(上海兴塔化工厂)
6.DL-天冬酸;(天津华北地区特种试剂开发中心)
7.甘露醇;(广州佳德化工有限公司)
8.磷酸二氢钾;(青岛市广汇化工厂)
9.白糖;(超市购买)
10.高锰酸钾;(天津恒兴化学制剂有限公司)
11.福尔马林;(山东济南试剂厂)
12.试管菌丝母种。
器具:
1.500ml玻璃瓶;
2.手提高压锅,电煤双用;(上海申仪三厂)
3.摇床:D4-900;(江苏太仑市实验设备厂)
4.超净工作台;
5.酒精灯;
6.勾、耙、针、刀;
7.火柴;
8.消毒棉花;
9.75%乙醇;10.橡皮筋。
方法:
1).在15kg步骤1得到的药物水提取液内分别加入50g磷酸氢二钾、50g磷酸二氢钾、20g硫酸锌、20g天冬酸、20g甘露醇、500g白糖、200g酵母浸膏,搅拌并加温至100℃,放入1000g营养琼脂培养基,溶化后再添加中药水提取液制成25kg混浊液。
2).将12.5kg混浊液注入500ml玻璃瓶内,每瓶400ml,一共得12瓶,置入手提高压锅内在0.012MP/cm2,30min,取出后冷却至28℃-34℃,放入超净工作台内。
3).工具和器具以及灭活后的培养基放入超净工作台内,用30g高锰酸钾置入盛有50%福尔马林30ml的器皿中,接种用的勾、耙、针、刀放入该器皿中灭菌30min。将试管内黑木耳菌丝母种,切成3份,每份分别接入400ml/瓶的混浊液内,静养120min~150min。
4).在摇床上以20次/min,振荡72~96小时即分别得到黑木耳菌丝母种液。
重复步骤2)~4),在另外剩下的12.5kg混浊液中接种制备灰树花菌丝母种液。
步骤3.深层发酵
将步骤1获得的药物水提取液置于题为《食用菌液体菌种培养罐的罐盖及培养罐》专利号为ZL03270560.3的发酵罐中作为发酵底物。并将发酵罐推入《饱和蒸气无压锅炉》专利号为ZL200320126611.8的的锅炉中常压水蒸汽灭活12小时。待罐内底物冷却至28~34℃时,用名称为“食用菌液体注射杆及包含该注射杆的注射器”专利号为ZL200320126960.X的接种注射器,将步骤2制备得到的黑木耳菌丝母种液和灰树花菌丝母种液注入到药物水提取液中;接种量:两种菌丝母种液与药物水提取液的体积比例都为5~15∶100,在24~29℃(其中灰树花菌丝生长的适宜温度为28℃,黑木耳菌丝生长适宜温度为:15~36℃)环境下深层发酵72~114小时,放罐。
步骤4.制取药物:
放罐后得到的深层发酵产物,进行浓缩,焙干,过筛得粉状制品10kg,部分保留粉剂状态,制成胶囊,每粒含0.35g粉剂。
实施例2.
步骤1.中药水提取物制备
中药原料及其重量份:当归1份、麦冬3份、天冬1份、炒酸枣仁8份、柏子仁9份、远志15份、生地3份、苦参5份、丹参15份、元参15份、黄岑8份、桔梗15份、五味子15份。
按上述原料药组分一共称取25kg,至于置于140kg饮用水中,大火煮沸,并用小火再煎煮两小时,过滤取汁约得到65~80kg,留药渣,并再注入130kg饮用水,大火煮沸后小火再煎煮三小时,过滤取汁约得到60~70kg,弃渣,将两次药汁合并,总计重量约150kg药物水提取液。
其它步骤同实施例1.
实施例3
当归3份、麦冬1份、天冬3份、炒酸枣仁15份、柏子仁15份、远志5份、生地8份、苦参12份、丹参8份、元参8份、黄岑12份、桔梗5份、五味子9份。
按上述原料药组分一共称取20kg,至于置于140kg饮用水中,大火煮沸,并用小火再煎煮两小时,过滤取汁约得到65~80kg,留药渣,并再注入130kg饮用水,大火煮沸后小火再煎煮三小时,过滤取汁约得到60~70kg,弃渣,将两次药汁合并,总计重量约150kg药物水提取液。
其它步骤同实施例1.
实验例1.
门诊收治300余例,观察300例,治愈表现为:入睡容易,睡眠深沉少梦,停药后,每日困意发生时间有规律,睡眠需要时间短,身体各项指标都恢复正常。
100例服用实施例1制备得到的胶囊或粉状制剂,3次/天,5颗/次(胶囊)或1.75g/次(粉剂),服用三天有效,三周后停药,治愈率为99%,治愈表现为:入睡容易,睡眠深沉少梦,每日困意发生时间有规律,睡眠需要时间短。未见不适者。
100例服用实施例2制备得到的胶囊或粉状制剂,服用方法同上,服用三天有效,三周后停药,有效率为99%,未见不适者。
100例服用实施例3制备得到的胶囊或粉状制剂,服用方法同上,服用三天有效,三周后停药,有效率为99%,未见不适者。
上述实例最长服用五周,最短七天,见效后不存在对本药物的依赖。
特殊病例:
邵海荣,女,1977年出生,中山市彩虹桥百联药店经理,手机号码:13900057885。顽固性失眠近两年,服药两周,已痊愈,两年间未复发。
罗燕,女,1979年出生,贵州贵阳龙里县人,身份证号码:522730197909291228,手机号码:13085894022。彻夜未眠数周,服药两周,已痊愈。
Claims (8)
1.一种治疗失眠的药物,是灰树花(Griflola frondosa)母种和黑木耳母种以以下中药原料药混合物的水提取液为培养基的发酵产物;所述中药原料药混合物为:当归1~3份、麦冬1~3份、天冬1~3份、炒酸枣仁5~15份、柏子仁5~15份、远志5~15份、生地3~8份、苦参5~15份、丹参5~15份、元参5~15份、黄岑5~15份、桔梗5~15份、五味子5~15份。
2.根据权利要求1所述的治疗失眠的药物,所述中药原料药混合物为:当归2份、麦冬2份、天冬2份、炒酸枣仁10份、柏子仁10份、远志10份、生地5份、苦参10份、丹参10份、元参10份、黄岑10份、桔梗10份、五味子10份。
3.根据权利要求1所述的治疗失眠的药物,所述灰树花母种指有增殖活力的灰树花菌丝,所述黑木耳母种指黑木耳菌丝。
4.以权利要求1~3任一所述的治疗失眠的药物为有效成分的药剂。
5.权利要求1~3任一所述治疗失眠的药物的制备方法,其特征在于:将灰树花母种与黑木耳母种接种到所述中药原料药混合物的水提取液中发酵。
6.根据权利要求5所述的制备方法,所述发酵步骤为:
(1)制备中药原料药混合物的水提取液:在所述中药原料药的混合物中加饮用水煎煮提取两次,每次过滤取汁,后一次弃渣,合并两次所取的水提取物,所述水提取物中原料药的质量百分比为10~20%;
(2)接种:对水提取物进行常压灭活,待冷却至常温,接种灰树花菌丝母种和黑木耳菌丝母种;
(3)深层发酵:发酵时间为72~114小时。
7.根据权利要求6所述的制备方法,所述常压灭活指常压下水蒸12小时。
8.根据权利要求5~7任一所述的制备方法,所述深层发酵72~114小时后,对发酵产物进行放罐、浓缩、焙干、过筛最后得粉状制品。
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CN107029080A (zh) * | 2017-04-26 | 2017-08-11 | 杭州敦和科技有限公司 | 一种改善睡眠并能增强机体免疫力的药物及制备方法 |
CN107837323A (zh) * | 2017-11-22 | 2018-03-27 | 中山市择朋生物科技有限公司 | 一种用于痛风的经皮肤给药制品及其制备方法 |
CN108403877A (zh) * | 2018-05-24 | 2018-08-17 | 高承峰 | 一种具有减肥、改善睡眠的中药组合物及其制备方法 |
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CN1339581A (zh) * | 2001-09-29 | 2002-03-13 | 李宝健 | 灰树花大规模液体深层发酵工艺 |
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CN108403877A (zh) * | 2018-05-24 | 2018-08-17 | 高承峰 | 一种具有减肥、改善睡眠的中药组合物及其制备方法 |
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