CN116370578A - 可用于治疗失眠的中药组合物及其制备方法 - Google Patents
可用于治疗失眠的中药组合物及其制备方法 Download PDFInfo
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- CN116370578A CN116370578A CN202310563455.3A CN202310563455A CN116370578A CN 116370578 A CN116370578 A CN 116370578A CN 202310563455 A CN202310563455 A CN 202310563455A CN 116370578 A CN116370578 A CN 116370578A
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Abstract
本发明公开了可用于治疗失眠的中药组合物,按照质量百分比由下列组分组成:酸枣仁:15.5%~20.41%,龟板:7.7%~7.79%,龙骨:7.7%~7.79%,磁石:5.19%~5.95%,远志:3.88%~4.67%,香附:2.92%~4.46%,石菖蒲:3.49%~4.46%,合欢皮:7.7%~8.93%,鸡内金:2.59%~2.97%,川芎:2.59%~2.6%,当归:2.59%~2.6%,茯神:2.9%~6.23%,柏子仁:2.59%~3.11%,半夏:1.94%~2.6%,桔梗:1.94%~2.6%,生地:3.88%~5.2%,沉香:1.55%~1.6%,天麻:1.81%~2.6%,人参:2.59%~2.6%,元胡:1.81%~2.6%,藁本:2.72%~3.9%,决明子:3.62%~5.2%。本发明制备方法简单,易于生产。
Description
技术领域
本发明属于医药技术领域,涉及可用于治疗失眠的中药组合物,还涉及可用于治疗失眠的中药组合物的制备方法。
背景技术
随着社会的发展,生活节奏的加快,竞争日趋激烈,加之自然环境变化以及人口老龄化及疾病谱的改变,失眠的发病率急剧上升。长期失眠影响个体的正常生活和工作,增加罹患各种健康问题的风险,加重或诱发心慌、头晕、头痛及其它心脑血管疾病,严重的睡眠缺失将降低患者的工作效率和警觉水平,甚至有可能引发恶性意外事故,造成巨大损失。失眠已成为一个公共卫生问题。
现多领域、多类型、多样化的睡眠产品络绎不绝出现。目前的睡眠产品主要包括医药保健品、睡眠APP(通常包含睡眠监测、提供白噪声等功能)、睡眠仪、智能睡眠监测手环以及助眠枕头、智能床垫等居家产品,而这些产品在促进睡眠方面的疗效并不理想。目前用于治疗失眠的常用药物主要可分为苯二氮类和非苯二氮/>五类:①苯二氮卓类(BZD);②抗抑郁药,如阿米替林、多虑平;③抗组织胺类,如安泰乐;④巴比妥及非巴比妥类,如巴比妥、鲁米那;⑤抗精神病药物及其它镇静药,如氯丙嗪,其治疗失眠的效果较好,但药物易产生耐药性、成瘾性及认知功能损害等多种副作用,影响了在临床中的应用。
中医以其独特的视角,在2000多年的临床实践中,发展出了效果良好、安全性高、而又独具特色的理法方药。用于治疗睡眠的纯中药制剂研发成为研究热点。失眠症主要分成六型:气血不足、肝郁气滞、营血蕴热、脾胃不和、肝火旺盛、心肾不交,而目前常用于治疗老年失眠的中药主要以养心安神药为基础或以失眠单一型为基础进行药物的研发。比如养血宁心类:养血安神颗粒/片/糖浆/,枣仁安神液,更年安,安神补脑液,朱砂安神丸,琥珀安神丸,利心丸,脑心舒口服液;补益心脾类:参芪五味子片,心达康,强力脑清素片,五味安神颗粒,养心宁神丸;疏肝解郁类:解郁安神颗粒,更年宁;重镇安神类:磁朱丸,补益心脾类:孔圣枕中丸,利尔眠胶囊/片等;其存在见效慢、中医辩证繁琐的问题。
发明内容
本发明的目的是提供可用于治疗失眠的中药组合物,解决了现有治疗失眠的西药存在不良反应及药物依赖性、中药见效慢及中医辩证繁琐的问题。
本发明的另一目的是提供可用于治疗失眠的中药组合物的制备方法。
本发明所采用的技术方案是,可用于治疗失眠的中药组合物,按照质量百分比由下列组分组成:酸枣仁:15.5%~20.41%,龟板:7.7%~7.79%,龙骨:7.7%~7.79%,磁石:5.19%~5.95%,远志:3.88%~4.67%,香附:2.92%~4.46%,石菖蒲:3.49%~4.46%,合欢皮:7.7%~8.93%,鸡内金:2.59%~2.97%,川芎:2.59%~2.6%,当归:2.59%~2.6%,茯神:2.9%~6.23%,柏子仁:2.59%~3.11%,半夏:1.94%~2.6%,桔梗:1.94%~2.6%,生地:3.88%~5.2%,沉香:1.55%~1.6%,天麻:1.81%~2.6%,人参:2.59%~2.6%,元胡:1.81%~2.6%,藁本:2.72%~3.9%,决明子:3.62%~5.2%,以上组分的质量百分比之和为100%。
本发明所采用的另一技术方案是,可用于治疗失眠的中药组合物的制备方法,具体按照以下步骤实施:
步骤1,称取如下原料:酸枣仁、龟板、龙骨、磁石、远志、香附、石菖蒲、合欢皮、鸡内金、川芎、当归、茯神、柏子仁、半夏、桔梗、生地、沉香、天麻、人参、元胡、藁本、决明子;
步骤2,将步骤1称取的酸枣仁进行粉碎,粉碎后加入纯化水进行浸泡,浸渍提取,过滤,得到滤液,将得到的滤液进行真空浓缩,得到浓缩液,放至室温,加入乙醇,静置,再次过滤,并将醇沉物经离心甩干,得到酸枣仁提取物,冷藏,备用;
步骤3,将除酸枣仁外的其余原料混合后干燥、粉碎、过筛、得到生药粉,备用;
步骤4,将步骤2得到的酸枣仁提取物与步骤3得到的生药粉拌合均匀,干燥、粉碎、过筛,得到可用于治疗失眠的中药组合物。
本发明的特征还在于,
步骤2中,浸渍提取的温度为80℃~90℃,提取次数为3次,将3次提取液合并后再进行过滤。
步骤2中,纯化水的添加量为酸枣仁质量的10倍~20倍,真空浓缩的温度为70℃~80℃。
步骤2中,乙醇的质量浓度为70%,乙醇的添加量为浓缩液体积的70%。
步骤3中,干燥的温度为50℃~60℃。
步骤4中,干燥的温度为60℃~70℃。
步骤4中,将得到的可用于治疗失眠的中药组合物经Co60照射灭菌,质检合格后装入胶囊即可。
步骤1中,原料的质量百分为:酸枣仁:15.5%~20.41%,龟板:7.7%~7.79%,龙骨:7.7%~7.79%,磁石:5.19%~5.95%,远志:3.88%~4.67%,香附:2.92%~4.46%,石菖蒲:3.49%~4.46%,合欢皮:7.7%~8.93%,鸡内金:2.59%~2.97%,川芎:2.59%~2.6%,当归:2.59%~2.6%,茯神:2.9%~6.23%,柏子仁:2.59%~3.11%,半夏:1.94%~2.6%,桔梗:1.94%~2.6%,生地:3.88%~5.2%,沉香:1.55%~1.6%,天麻:1.81%~2.6%,人参:2.59%~2.6%,元胡:1.81%~2.6%,藁本:2.72%~3.9%,决明子:3.62%~5.2%,以上组分的质量百分比之和为100%。
本发明的有益效果是,
(1)本发明中药组合物,为纯中药组方,以“整体辨证论治”为原则,中药复方可益阴潜阳,柔肝养血,安神益智,健脾益胃,祛痰化湿。治法兼顾传统中医组方对失眠的整体辩证观,同时考虑当今治病因素及病机的转变,多重立论,整体调整所涉兼夹证,建立了“益阴潜阳”“柔肝养血”“健脾益胃”“祛痰化湿”“安神益智”为治则的失眠治疗新理念、新方法,针对失眠“君臣佐使治法”,治疗的针对性更强,临床效果更好,适用于各种原因所致失眠证、更年期综合征、抑郁症及轻度躁狂症,与以往以养心安神药为基础或以失眠单一型为基础的安神类药物具有显著的治疗优势及临床应用效果;
(2)本发明中药组合物,具有疗效显著,快速见效,无毒副反应,临床可长期服用特点,可以从根本上解决失眠长期依赖药物的弊端;
(3)本发明中药组合物,采用了药食两用与可用于保健食品的中药材,绿色天然、安全无毒,常服获益,对于各种诱因诱发的失眠均具有治疗和预防作用。
具体实施方式
下面结合具体实施方式对本发明进行详细说明。
本发明一种可用于治疗失眠的中药组合物,按照质量百分比由下列组分组成:酸枣仁:15.5%~20.41%,龟板:7.7%~7.79%,龙骨:7.7%~7.79%,磁石:5.19%~5.95%,远志:3.88%~4.67%,香附:2.92%~4.46%,石菖蒲:3.49%~4.46%,合欢皮:7.7%~8.93%,鸡内金:2.59%~2.97%,川芎:2.59%~2.6%,当归:2.59%~2.6%,茯神:2.9%~6.23%,柏子仁:2.59%~3.11%,半夏:1.94%~2.6%,桔梗:1.94%~2.6%,生地:3.88%~5.2%,沉香:1.55%~1.6%,天麻:1.81%~2.6%,人参:2.59%~2.6%,元胡:1.81%~2.6%,藁本:2.72%~3.9%,决明子:3.62%~5.2%,以上组分的质量百分比之和为100%。
本发明可用于治疗失眠的中药组合物的制备方法,具体按照以下步骤实施:
步骤1,按照质量百分比分别称取如下原料:酸枣仁:15.5%~20.41%,龟板:7.7%~7.79%,龙骨:7.7%~7.79%,磁石:5.19%~5.95%,远志:3.88%~4.67%,香附:2.92%~4.46%,石菖蒲:3.49%~4.46%,合欢皮:7.7%~8.93%,鸡内金:2.59%~2.97%,川芎:2.59%~2.6%,当归:2.59%~2.6%,茯神:2.9%~6.23%,柏子仁:2.59%~3.11%,半夏:1.94%~2.6%,桔梗:1.94%~2.6%,生地:3.88%~5.2%,沉香:1.55%~1.6%,天麻:1.81%~2.6%,人参:2.59%~2.6%,元胡:1.81%~2.6%,藁本:2.72%~3.9%,决明子:3.62%~5.2%,以上组分的质量百分比之和为100%。
步骤2,将步骤1称取的酸枣仁进行粉碎,粉碎后加入纯化水进行浸泡50分钟,在80℃~90℃下浸渍提取60分钟,共提取3次,将3次提取液合并后用80目筛过滤,得到滤液,将得到的滤液在70℃~80℃下进行真空浓缩,得到浓缩液,放至室温,加入质量浓度为70%的乙醇,静置24h,再次过滤,并将醇沉物经离心甩干,得到酸枣仁提取物,-4℃冷藏,备用;
其中,纯化水的添加量为酸枣仁质量的10倍~20倍;
乙醇的添加量为浓缩液体积的70%;
每1mL浓缩液相当于原药材1g。
步骤3,将除酸枣仁外的其余原料混合后在50℃~60℃下干燥、粉碎、过40目筛、得到生药粉,备用;
步骤4,将步骤2得到的酸枣仁提取物与步骤3得到的生药粉拌合均匀,在60℃~70℃下干燥、粉碎、过60目筛,得到可用于治疗失眠的中药组合物,将得到的可用于治疗失眠的中药组合物经Co60照射灭菌,质检合格后装入胶囊即可。
以下从原理方面说明本发明的关键点所在:
本发明是根据失眠的生理及病理特点,以及发明人多年大量临床使用治疗失眠过程中逐步探索并建立的以“益阴潜阳”“柔肝养血”“健脾益胃”“祛痰化湿”“安神益智”为治则,首创“君臣佐使治法”的治疗新理念研制而成。传统中医学认为失眠病机复杂,系由于感受外邪,情志刺激、饮食不节、脾胃受损、年迈病后或禀赋不足等多种原因所致;加之当今失眠多由精神因素、不良生活习惯、环境污染三大致病因素所致,均引起营卫失调、气血津液不足、神失所养致脏腑失调、阴阳失和、消髓蚀脑。因此,鉴于失眠致病因素及新的病理机制的转变,本发明多重立论,首创针对失眠君臣佐使之治法,建立了“益阴潜阳”“柔肝养血”“健脾益胃”“祛痰化湿”“安神益智”为治则的失眠治疗新理念、新方法,整体调整失眠所涉兼夹证,经临床实践应用,其治疗的针对性更强,临床效果更好。“滋补肝肾之阴”乃为“君”,因阴虚为本,故当首治,治以滋阴潜阳;“柔肝养血”乃为“臣”。治法一改既往传统疏肝理气治法,“肝虽为刚脏,但亦不可攻伐,即便过度疏肝理气,对失眠亦非正途,故以“肝可柔可养”立论,使其“肝阳得阴自潜,肝气归巢之义”。“健脾益胃”乃为“佐”,其一益气健脾,养血助阴,其二脾健痰消,无痰胃安,胃安寝酣之意。“祛痰化湿”乃为“使”,取其兼夹痰、湿等外邪所弊,治当适当祛风化痰除湿之意。“安神益智”乃治疗之最终目的使脑神得安,神有所寄、所依、所养,则失眠等诸症便可迎刃而解。故“益阴潜阳”“柔肝养血”“健脾益胃”“祛痰化湿”“安神益智”切合失眠的基本病机,是治疗失眠的主要方法。此外,本发明采用了药食两用与可用于保健食品的天然中药材遣药组方,再经现代制剂技术制备而成,有效保持了中药材多成分、多靶点、多功效的综合作用特点,充分发挥了整体调整失眠所涉兼夹证药理功效。本发明为采用天然中药制剂制成的保健药物,绿色天然、安全无毒,具有“益阴潜阳”“柔肝养血”“健脾益胃”“祛痰化湿”“安神益智”的功效,依托君臣佐使之治法治疗各种原因引起的失眠具有确切的治疗作用。
本发明采用酸枣仁、龟板、龙骨、磁石、远志、香附、石菖蒲、合欢皮、鸡内金、川芎、当归、茯神、柏子仁、半夏、桔梗、生地、沉香、天麻、人参、元胡、藁本、决明子,其中:
酸枣仁,性甘、酸,性平,入脑、心、肝经,具有养肝,宁心,安神,敛汗功效,主脑神紊乱、失眠、惊悸之证。
龟板,具有滋阴,潜阳,补肾,健骨功效。
龙骨,味涩、甘,性平,入心、肝、肾、大肠经。具有镇心安神,平肝潜阳,固涩收敛功效。治惊痫癫狂,怔忡健忘,失眠多梦,自汗盗汗,遗精淋浊。如《本草纲目》记载:“益肾镇惊”。如《药性论》记载:“逐邪气,安心神,止梦泄精,梦交,虚而多梦纷纭加而用之。”
磁石,辛咸、平、无毒,归肾经、肝经、肺经。具有平肝潜阳、安神镇惊、聪耳明目、纳气平喘功效。主眩晕、目花、耳聋、耳鸣、惊悸、失眠、肾虚喘逆。取其质重能安神镇惊。四者三镇、一养,共奏安脑神,平神乱而为君。臣药:以白芍,当归,龟板,生地,柏子仁、合欢皮、香附、炒决明子辅佐君药酸枣仁之养肝柔肝,助三重镇之下潜有形,以达养肝柔肝之臣功。使其“肝阳得阴自潜,肝气归巢之义”。
远志,味苦、辛,性微温,归心、肾、肺经,有宁心安神、祛痰开窍、消散痈肿的作用。其能开心气而宁心安神,又能通肾气,强志不忘,为交通心肾安神定志之佳品,多用于治疗心肾不交之心神不宁,惊悸不安,失眠,健忘等,其能祛痰,利心窍,可以治疗痰阻心窍的癫痫抽搐和痰迷癫狂。其还能祛痰镇咳,疏通气血雍滞,虚实寒热,都可以使用。
香附,辛微苦甘,平。入肝、三焦经。具有理气解郁,调经止痛功效。
石菖蒲,性温,味苦,归心、胃经,具有开窍醒神、化湿和胃、宁神益智功效,如《本草备药》记载:辛苦而温,芳香而散。补肝益心,开心孔,利九窍,明耳目,发音声。去湿逐风,除痰消积,开胃宽中。芳香利窍,心脾良药,能佐地黄之属,资其宣导。
合欢皮,味甘,性平,归心肝肺经。具有解郁安神功能,其安神作用强于等剂量的酸枣仁,具有较强的镇静安神功效。如《神农本草经》记载:“主安五脏,和心志,令人欢乐无忧。”如《萃金裘本草述录》记载:“补阴气,宁心志,解郁结。”
鸡内金,甘,寒。归脾、胃、小肠、膀胱经,消食健胃助消化,涩精止遗。以助金石之消导。如《医学衷中参西录》记载:“鸡内金,鸡之脾胃也,中有瓷石、铜、铁皆能消化,其善化瘀积可知。健补脾胃之妙品,脾胃健壮,益能运化药力以消积也。”
川芎,性味辛、温,入肝经,行气开郁、祛除风燥湿、活血止痛。如《医学启源》记载:补血,治血虚头痛。
当归,为血中圣药,性味甘、辛、温,具有活血、补血、调经、止痛,润燥滑肠的功效。
茯神,性平,味甘、淡,归心经、脾经,具有宁心、安神、利水功效。
柏子仁,甘,平。归心、肾、大肠经,柏子仁香气透心,体润滋血。同茯神、枣仁、生地为浊中清品,主治心神虚怯,惊悸怔仲,面色憔悴,肌肤燥痒,皆养心血之功也。又取气味俱浓,浊中归肾,同龟版为封填骨髓,味甘亦能缓肝,补肝胆之不足,极其稳当。如《本草纲目》记载:“养心气,润肾燥,安魂定魄,益智宁神。”如《本草纲目》记载:“柏子仁性平而不寒不燥,味甘而补,辛而能润,其气清香,能透心肾,益脾胃。”柏子仁与酸枣仁皆能养心安神,滋阴止汗。然柏子仁重在补心,酸枣仁专于补肝,病机有异;柏子仁润燥力强,可润肠通便,酸枣仁敛阴力胜,能生津止渴,兼治不同,与君药酸枣仁呼应。
半夏,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。
桔梗,性平,味苦、辛。归肺经。具有宣肺祛痰、利咽排脓功效。一取其载药上行,直达脑窍,二取其祛痰治痰要药。现代药理具有抗炎、镇静、镇痛、解热、松弛平滑肌、防治消化道溃疡作用。
生地,具有凉血滋阴功效,以补肾宁心法治之。
沉香,辛、苦,温。归脾、胃、肾、肺经,具有降气温中,暖肾纳气功效。
天麻,气微,性平,味甘,微辛,具有平肝潜阳,祛风通络功效,以其镇静、镇痛、抗惊厥,明目増智为治疗目的。
人参,味甘、微苦,性微温,归脾、肺、心、肾经,气雄体润,升多于降;具有补气固脱,健脾益肺,宁心益智,养血生津的功效。
元胡,味辛、苦,性温。活血散瘀,镇痛、镇静作用最为显著。人参、茯神、川芎、远志“健脾益胃”而为佐药。取《杂病源流犀烛·脏腑门》卷七方之归神丹之意功能益气养血,宁心安神,治心气不足,神不守舍。
藁本,该品辛温辛散,一取其善达头之巅顶之功做引经药使用;二取温性来防止方中过于苦寒滋腻;三是借其温性令药气循经络上达于脑,使气血宣行而无奎滞。天麻、沉香合用乃上下对药,上达脑窍,下至肾阴。为君臣佐使之信药,贯穿周身之气血上通下达,流注周身百骸。
决明子,具有平肝养肾的功效。
本发明的中药组合物以重用酸枣仁养肝血,安心神为君药;磁石、龟板、龙骨入肾,益阴潜阳,重镇安神以为臣药,佐以当归、川芎调养肝血。生地凉血滋阴,水火既济,交通心肾,配以茯神宁心安神,已达心安神藏,乃能入寐。半夏为祛痰首药,取痰去则诸病安之效。人参安神益智,乃补虚之重药。另取气之所致,药之所达。石菖蒲、合欢、远志取其肝郁得畅之功,郁解则寝安。元胡、藁本、决明子乃加减所用,其用有二:一是,以祛风、潜阳、活血定痛之良药,二是,兼以引经。天麻、桔梗、沉香合用乃上下对药,上达脑窍,下至肾阴。方中所含甲石之品,联用鸡内金以运脾消食,顾护胃气兼敛涩之功。香附为妇科圣药,乃特为考虑妇人行经头痛所列。加减柏子仁实为心悸,便难所用。以上诸药合用,适合常服获益。
本发明中药组合物特点一:方中首创不寐治疗中医君臣佐使施治之先河,建立了君为君治,臣为臣治,佐使并重的治疗理念。该理念既总结了前人先哲对不寐的整体治疗观,又考虑到当今社会生活所致的现代治病因素,古今并重,辩证施治。方中诸药:君重臣繁,佐用使行。药物配伍紧密,药性药味,升降浮沉,寒热并举,使用灵活。治君,治臣,治佐,治使中各亦有君臣佐使之细分,其它亦然。诸药诸法相兼使用,章法自然。
本发明中药组合物特点二:方中诸药都有安神或补脑宁脑之功,建立了“益阴潜阳”“柔肝养血”“健脾益胃”“祛痰化湿”“安神益智”治疗失眠新方法、新理念。诸药合用不但能契合失眠发生的根本病机,而且具有调和阴阳,扶正兼可祛邪,标本兼顾等优势,方中诸药合用可具有安神、宁脑、疏理气机、调和阴阳以及益气化痰活血之功。因此,组方优势为以宁脑安神为主攻方向,注重以多靶点,多方位来治疗失眠。
本发明中药组合物特点三:中医治未病之理念,防治因失眠而变生他病。方中安神养神,逆转脑实质逆乱;养肝柔肝化解肝阴肝血之耗损;益气健脾,化痰和胃,乃考虑体虚之态,培补后天之本,脾胃方可有治病之机,脾胃强,先天得补,则安神益智。
本发明采用了药食两用与可用于保健食品的天然中药材遣药组方,再经现代制剂技术制备而成,绿色安全、疗效可靠,口服后能够治疗失眠与兼顾护胃气兼敛涩的双重药理功效;解决了目前西药药物治疗易产生耐药性、成瘾性、认知功能损害、“治标不治本”而疗效不佳易于复发,并加重肝肾负担、损伤肝肾功能等多种副作用的弊端;也解决了临床上因失眠病因复杂辩证施治难而影响中医药临床应用的弊端。
实施例1
本发明一种可用于治疗失眠的中药组合物,按照质量百分比由下列组分组成:酸枣仁:18.03%,龟板:7.77%,龙骨:7.77%,磁石:5.95%,远志:3.88%,香附:4.46%,石菖蒲:4.46%,合欢皮:8.93%,鸡内金:2.97%,川芎:2.59%,当归:2.59%,茯神:2.9%,柏子仁:2.59%,半夏:2.59%,桔梗:1.94%,生地:3.88%,沉香:1.55%,天麻:2.59%,人参:2.59%,元胡:2.59%,藁本:2.72%,决明子:4.66%,以上组分的质量百分比之和为100%。
本发明可用于治疗失眠的中药组合物的制备方法,具体按照以下步骤实施:
步骤1,按照质量百分比分别称取如下原料:酸枣仁:18.03%,龟板:7.77%,龙骨:7.77%,磁石:5.95%,远志:3.88%,香附:4.46%,石菖蒲:4.46%,合欢皮:8.93%,鸡内金:2.97%,川芎:2.59%,当归:2.59%,茯神:2.9%,柏子仁:2.59%,半夏:2.59%,桔梗:1.94%,生地:3.88%,沉香:1.55%,天麻:2.59%,人参:2.59%,元胡:2.59%,藁本:2.72%,决明子:4.66%,以上组分的质量百分比之和为100%;
步骤2,将步骤1称取的酸枣仁进行粉碎,粉碎后加入纯化水进行浸泡50分钟,在80℃下浸渍提取60分钟,共提取3次,将3次提取液合并后用80目筛过滤,得到滤液,将得到的滤液在70℃下进行真空浓缩,得到浓缩液,放至室温,加入质量浓度为70%的乙醇,静置24h,再次过滤,并将醇沉物经离心甩干,得到酸枣仁提取物,-4℃冷藏,备用;
其中,纯化水的添加量为酸枣仁质量的10倍;
乙醇的添加量为浓缩液体积的70%。
步骤3,将除酸枣仁外的其余原料混合后在50℃下干燥、粉碎、过40目筛、得到生药粉,备用;
步骤4,将步骤2得到的酸枣仁提取物与步骤3得到的生药粉拌合均匀,在60℃下干燥、粉碎、过60目筛,得到可用于治疗失眠的中药组合物,将得到的可用于治疗失眠的中药组合物经Co60照射灭菌,质检合格后装入胶囊即可。
实施例2
本发明一种可用于治疗失眠的中药组合物,按照质量百分比由下列组分组成:酸枣仁:15.5%,龟板:7.7%,龙骨:7.7%,磁石:5.2%,远志:3.9%,香附:3.9%,石菖蒲:3.9%,合欢皮:7.7%,鸡内金:2.6%,川芎:2.6%,当归:2.6%,茯神:5.2%,柏子仁:2.6%,半夏:2.6%,桔梗:2.6%,生地:5.2%,沉香:1.6%,天麻:2.6%,人参:2.6%,元胡:2.6%,藁本:3.9%,决明子:5.2%,以上组分的质量百分比之和为100%。
本发明可用于治疗失眠的中药组合物的制备方法,具体按照以下步骤实施:
步骤1,按照质量百分比分别称取如下原料:酸枣仁:15.5%,龟板:7.7%,龙骨:7.7%,磁石:5.2%,远志:3.9%,香附:3.9%,石菖蒲:3.9%,合欢皮:7.7%,鸡内金:2.6%,川芎:2.6%,当归:2.6%,茯神:5.2%,柏子仁:2.6%,半夏:2.6%,桔梗:2.6%,生地:5.2%,沉香:1.6%,天麻:2.6%,人参:2.6%,元胡:2.6%,藁本:3.9%,决明子:5.2%,以上组分的质量百分比之和为100%;
步骤2,将步骤1称取的酸枣仁进行粉碎,粉碎后加入纯化水进行浸泡50分钟,在85℃下浸渍提取60分钟,共提取3次,将3次提取液合并后用80目筛过滤,得到滤液,将得到的滤液在75℃下进行真空浓缩,得到浓缩液,放至室温,加入质量浓度为70%的乙醇,静置24h,再次过滤,并将醇沉物经离心甩干,得到酸枣仁提取物,-4℃冷藏,备用;
其中,纯化水的添加量为酸枣仁质量的15倍;
乙醇的添加量为浓缩液体积的70%。
步骤3,将除酸枣仁外的其余原料混合后在55℃下干燥、粉碎、过40目筛、得到生药粉,备用;
步骤4,将步骤2得到的酸枣仁提取物与步骤3得到的生药粉拌合均匀,在65℃下干燥、粉碎、过60目筛,得到可用于治疗失眠的中药组合物,将得到的可用于治疗失眠的中药组合物经Co60照射灭菌,质检合格后装入胶囊即可。
实施例3
本发明一种可用于治疗失眠的中药组合物,按照质量百分比由下列组分组成:酸枣仁:20.41%,龟板:7.79%,龙骨:7.79%,磁石:5.19%,远志:4.67%,香附:2.92%,石菖蒲:3.49%,合欢皮:7.79%,鸡内金:2.59%,川芎:2.59%,当归:2.59%,茯神:6.23%,柏子仁:3.11%,半夏:1.94%,桔梗:1.94%,生地:4.66%,沉香:1.55%,天麻:1.81%,人参:2.59%,元胡:1.81%,藁本:2.92%,决明子:3.62%,以上组分的质量百分比之和为100%。
本发明可用于治疗失眠的中药组合物的制备方法,具体按照以下步骤实施:
步骤1,按照质量百分比分别称取如下原料:酸枣仁:20.41%,龟板:7.79%,龙骨:7.79%,磁石:5.19%,远志:4.67%,香附:2.92%,石菖蒲:3.49%,合欢皮:7.79%,鸡内金:2.59%,川芎:2.59%,当归:2.59%,茯神:6.23%,柏子仁:3.11%,半夏:1.94%,桔梗:1.94%,生地:4.66%,沉香:1.55%,天麻:1.81%,人参:2.59%,元胡:1.81%,藁本:2.92%,决明子:3.62%,以上组分的质量百分比之和为100%;
步骤2,将步骤1称取的酸枣仁进行粉碎,粉碎后加入纯化水进行浸泡50分钟,在90℃下浸渍提取60分钟,共提取3次,将3次提取液合并后用80目筛过滤,得到滤液,将得到的滤液在80℃下进行真空浓缩,得到浓缩液,放至室温,加入质量浓度为70%的乙醇,静置24h,再次过滤,并将醇沉物经离心甩干,得到酸枣仁提取物,-4℃冷藏,备用;
其中,纯化水的添加量为酸枣仁质量的20倍;
乙醇的添加量为浓缩液体积的70%。
步骤3,将除酸枣仁外的其余原料混合后在60℃下干燥、粉碎、过40目筛、得到生药粉,备用;
步骤4,将步骤2得到的酸枣仁提取物与步骤3得到的生药粉拌合均匀,在70℃下干燥、粉碎、过60目筛,得到可用于治疗失眠的中药组合物,将得到的可用于治疗失眠的中药组合物经Co60照射灭菌,质检合格后装入胶囊即可。
以下从临床应用治疗情况进一步说明本发明所产生的有益效果:
1、患者资料
参照2017版《中医病证诊断疗效标准》及1993年发布的《中药新药治疗失眠的临床研究指导原则》中的中医诊断标准:①有失眠的典型症状:入睡困难,时常觉醒,睡而不稳或醒后不能再睡;晨醒过早;夜不能入睡,白天昏沉欲睡;睡眠不足5小时。②有反复发作史。选择111例经确诊为失眠的患者为研究对象,其中男性46例、女性65例,患者年龄21~70岁、病程0.5~10年、平均病程为4.39±0.31年。
2、治疗方法与疗效标准
用法用量:温开水空腹口服本发明胶囊剂,每天2次(10:00,21:00),每次3粒,15天为一疗程,共治疗2个疗程。
疗效判定:参照《中药新药临床研究指导原则》及《中药新药治疗失眠的临床研究指导原则》;
(1)失眠临床总疗效判定标准
①临床痊愈:睡眠时间恢复正常或夜间睡眠时间在6h以上,睡眠深沉,醒后精力充沛。②显效:睡眠明显好转,睡眠时间增加3h以上,睡眠深度增加。③有效:症状减轻,睡眠时间较前增加不足3h。④无效:失眠无明显改善或反加重者。
(2)中医症状疗效判断标准
①治愈:临床症状消失。②显效:临床症状积分值下降2/3。③有效:临床症状积分值下降1/3~2/3。④无效:临床症状积分值下降<1/3。
3、治疗结果
经过系统治疗后,治愈98例,治愈率为88.28%;显效13例,显效率为11.71%;无效0例;总有效率为100%。治疗后统计,患者反映在治疗过程中失眠等症状消除或缓解明显,治疗过程舒服且随着服药时间延长心情、饮食等也有明显改善,也未出现任何不良反应。表明本发明不仅具有确切的治疗失眠的功效,同时,绿色安全,无不良反应。
4、典型病例
(1)崔某,男,64岁,农民,2021年03月因年老多病,进食不节后出现入睡困难,多梦易醒,醒而难以复睡。2022年07月21日就诊。既往:患高凝血症。二型糖尿病,查体:T 36.4℃,P:83次/分,R:17次/分,BP:154/82mmHg,心肺腹查体未见异常。中医辨病辩证:舌质淡胖,轻度齿痕,苔白腻,脉洪。中医诊断:不寐,脾肾两虚。西医诊断:继发性失眠,高凝血症,二型糖尿病。使用本发明中药组合物治疗一个月后复诊睡眠改善明显。
(2)郝某,女,30岁,工人,出现肩背部,腰腿痛。双上肢麻木不适,颈部活动障碍,间断伴失眠、疲劳无力、食欲减退、体重减轻、手足盗汗、全身不适等症就诊。查体:T:36.2℃,P:82次/分,R:16次/分,BP:120/82mmHg,体型肥胖,心肺腹查体未见异常,右侧肩关节活动障碍,颈椎第3-7棘突触压痛,颈椎活动受限。腰椎第1-5棘突叩压痛,直腿抬高试验阳性。曾于门诊查腰椎CT示:腰椎生理曲度变直。腰椎骨质退行性病变,腰2-腰5椎间盘脱出,曾给予对症治疗,含激素治疗,非甾体类药物治疗,效果不佳。于2021年11月13日患者上述临床症状进一步加重,就诊给予中医辩证施治,于2021年11月28患者门诊复诊上述症状减轻后续间断巩固治疗。中医辨病辩证:舌质淡胖,轻度齿痕,舌络於阻,苔白腻,脉紧,面色晄白。辅助检查:腰椎CT示:腰椎生理曲度变直,腰2-5椎间盘膨出,腰椎骨质退行性病变。右肩部DR平片示:右肩关节炎。中医诊断:痹症,脾虚,痰瘀互阻。西医诊断:右肩关节炎,腰椎间盘突出症,继发性失眠。使用本发明中药组合物治疗一个月后复诊睡眠改善明显。
(3)焦某,女,43岁,产妇,2022年01月因产后受风出现肩背部,腰腿痛。双上肢麻木不适,颈部活动障碍,间断伴失眠、疲劳无力、食欲减退、体重减轻、手足盗汗、全身不适等症。既往患乳腺增生,轻度贫血。查体:T:36.2℃,P:88次/分,R:16次/分,BP:126/72mmHg,体型肥胖,心肺腹查体未见异常,右侧肩关节活动障碍,颈椎第3-7棘突触压痛,颈椎活动受限。腰椎第1-5棘突叩压痛,直腿抬高试验阳性。曾于门诊查腰椎CT示:腰椎生理曲度变直。腰椎骨质退行性病变,腰2-腰5椎间盘脱出,曾给予对症治疗,效果不佳。中医辨病辩证:舌质淡胖,轻度齿痕,苔白腻,脉浮紧。辅助检查:拒查。中医诊断:痹症,不寐,脾虚。西医诊断:右肩关节炎,腰椎间盘突出症,继发性失眠。使用本发明中药组合物治疗一个月后复诊睡眠改善明显。
(4)吕某,女,30岁,农民,2021年06月出现腰痛,双下肢放射性麻木不适,失眠,入睡困难,多梦易醒,醒而难以复睡。查体:T:36.7℃,P:80次/分,R:17次/分,BP:120/84mmHg,体型肥胖,心肺腹查体未见异常,腰椎第1-5棘突叩压痛,直腿抬高试验阳性,门诊查腰椎CT示:腰椎生理曲度变直,腰1-2,腰2-3,腰3-4椎间盘膨出,腰椎骨质退行性病变,中医辨病辩证:舌质淡胖,轻度齿痕,舌络於阻,苔白腻,脉紧,面色晄白。辅助检查:腰椎CT示:腰椎生理曲度变直,腰1-2,腰2-3,腰3-4椎间盘膨出,腰椎骨质退行性病变。中医诊断:痹症,不寐,脾虚,痰瘀互阻。西医诊断:腰椎间盘突出症,继发性失眠。使用本发明中药组合物治疗九个月后复诊睡眠显著改善。
Claims (9)
1.可用于治疗失眠的中药组合物,其特征在于,按照质量百分比由下列组分组成:酸枣仁:15.5%~20.41%,龟板:7.7%~7.79%,龙骨:7.7%~7.79%,磁石:5.19%~5.95%,远志:3.88%~4.67%,香附:2.92%~4.46%,石菖蒲:3.49%~4.46%,合欢皮:7.7%~8.93%,鸡内金:2.59%~2.97%,川芎:2.59%~2.6%,当归:2.59%~2.6%,茯神:2.9%~6.23%,柏子仁:2.59%~3.11%,半夏:1.94%~2.6%,桔梗:1.94%~2.6%,生地:3.88%~5.2%,沉香:1.55%~1.6%,天麻:1.81%~2.6%,人参:2.59%~2.6%,元胡:1.81%~2.6%,藁本:2.72%~3.9%,决明子:3.62%~5.2%,以上组分的质量百分比之和为100%。
2.如权利要求1所述的可用于治疗失眠的中药组合物的制备方法,其特征在于,具体按照以下步骤实施:步骤1,称取如下原料:酸枣仁、龟板、龙骨、磁石、远志、香附、石菖蒲、合欢皮、鸡内金、川芎、当归、茯神、柏子仁、半夏、桔梗、生地、沉香、天麻、人参、元胡、藁本、决明子;
步骤2,将步骤1称取的酸枣仁进行粉碎,粉碎后加入纯化水进行浸泡,浸渍提取,过滤,得到滤液,将得到的滤液进行真空浓缩,得到浓缩液,放至室温,加入乙醇,静置,再次过滤,并将醇沉物经离心甩干,得到酸枣仁提取物,冷藏,备用;
步骤3,将除酸枣仁外的其余原料混合后干燥、粉碎、过筛、得到生药粉,备用;
步骤4,将步骤2得到的酸枣仁提取物与步骤3得到的生药粉拌合均匀,干燥、粉碎、过筛,得到可用于治疗失眠的中药组合物。
3.根据权利要求2所述的可用于治疗失眠的中药组合物的制备方法,其特征在于,步骤2中,浸渍提取的温度为80℃~90℃,提取次数为3次,将3次提取液合并后再进行过滤。
4.根据权利要求2所述的可用于治疗失眠的中药组合物的制备方法,其特征在于,步骤2中,纯化水的添加量为酸枣仁质量的10倍~20倍,真空浓缩的温度为70℃~80℃。
5.根据权利要求2所述的可用于治疗失眠的中药组合物的制备方法,其特征在于,步骤2中,乙醇的质量浓度为70%,乙醇的添加量为浓缩液体积的70%。
6.根据权利要求2所述的可用于治疗失眠的中药组合物的制备方法,其特征在于,步骤3中,干燥的温度为50℃~60℃。
7.根据权利要求2所述的可用于治疗失眠的中药组合物的制备方法,其特征在于,步骤4中,干燥的温度为60℃~70℃。
8.根据权利要求2所述的可用于治疗失眠的中药组合物的制备方法,其特征在于,步骤4中,将得到的可用于治疗失眠的中药组合物经Co60照射灭菌,质检合格后装入胶囊即可。
9.根据权利要求2所述的可用于治疗失眠的中药组合物的制备方法,其特征在于,步骤1中,原料的质量百分为:酸枣仁:15.5%~20.41%,龟板:7.7%~7.79%,龙骨:7.7%~7.79%,磁石:5.19%~5.95%,远志:3.88%~4.67%,香附:2.92%~4.46%,石菖蒲:3.49%~4.46%,合欢皮:7.7%~8.93%,鸡内金:2.59%~2.97%,川芎:2.59%~2.6%,当归:2.59%~2.6%,茯神:2.9%~6.23%,柏子仁:2.59%~3.11%,半夏:1.94%~2.6%,桔梗:1.94%~2.6%,生地:3.88%~5.2%,沉香:1.55%~1.6%,天麻:1.81%~2.6%,人参:2.59%~2.6%,元胡:1.81%~2.6%,藁本:2.72%~3.9%,决明子:3.62%~5.2%,以上组分的质量百分比之和为100%。
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