CN114796096A - 一种用于安神助眠的药茶及其制备方法 - Google Patents
一种用于安神助眠的药茶及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种用于安神助眠的药茶,是以百合2~5重量份,酸枣仁0.5~2重量份,紫苏叶0.5~2重量份,山楂0.5~2重量份为原料药制备获得的袋泡茶剂,用以调节失眠人群精神情绪,对亚健康人群失眠患者起到有效干预作用。经实验验证,本发明药茶可以使患者的睡眠质量得到有效改善,达到良好的助眠效果。
Description
技术领域
本发明属于中药药物制备技术领域,涉及一种基于中草药原料的用于辅助提高睡眠质量的药物,以及该药物的制备方法。
背景技术
睡眠是中枢神经系统调控的一种重要的、基本的生理过程,与中枢神经系统内某些特定结构和递质作用有关。
失眠又称“不寐”,主要以不能正常入睡并影响体力及精力为主要特征,会给患者带来极大的痛苦和心理负担。失眠往往伴有焦虑抑郁情绪发生。近年来,随着现代生活节奏的加快,人们生活压力越来越大,亚健康状态人群越来越多,而失眠则是亚健康人群面临的最主要问题之一。
亚健康是指机体呈现疲劳、活力下降,反应能力、创造能力和适应能力减退的临床表现,但达不到确诊疾病相关标准的生理状态。临床研究显示,近75%的亚健康人群伴有失眠症状,部分患者需要服用安眠药物帮助维持睡眠,对患者身心健康和生活质量造成严重影响。亚健康人群的失眠问题已经引起社会各界的广泛重视,一般采用心理健康辅导缓解患者心情,或是服用镇静、安眠药物。但药物仅对患者短期有效,长期使用副作用多,易出现头晕、嗜睡、戒断等症状。因此,寻找一种更为安全且有效的改善亚健康人群睡眠质量的方法意义重大。
我国传统医学理论认为,失眠的病位在心,主要病机是脏腑功能失调,气血不和,从而导致心神不宁或心失所养。失眠的病因较多,其中以情志、饮食或气血亏虚等内伤病因居多,由这些病因引起脏腑气血失和,阴阳失调,主要是由心血虚、胆虚、脾虚、肾阴亏虚从而导致心失所养,由心火偏亢、肝郁、痰热、瘀血、胃失和降进而导致心神不安。
中医药治疗失眠症多遵循辨证论治。近年来,由于中药具有疗效明显、副作用少及不会产生药物耐受性等特点,成为治疗失眠、焦虑以及抑郁药物的研究热点。
百合苏叶汤治疗失眠始于清初。《范文甫专辑》中提到:苦不寐,百药不能治,召余处方,以百合一两,紫苏叶三钱,二味煎服,三贴而安。百合色白气平,其形象肺,能助呼吸之开阖,故主邪气腹胀心痛,盖气行,则邪散而胀痛解矣,主利大小便者,气化则出也;主补中益气者,气之发原于中也。苏色紫赤,枝茎空通,其气朝出暮入,有如经脉之气,昼行于阳,夜行于阴,是以苏叶能发表汗者,血液之汗也。枝茎能通血脉,故易思兰先生常用苏茎通十二经之关窍,治咽膈饱闷,通大小便,止下利赤白。予亦常用香苏细茎,不切断,治反胃膈食,吐血下血,多奏奇功。盖食气入胃,散精于肝。浊气归心,肝主血,而心主脉。血脉疏通,则食饮自化。
中医名家张志聪的《侣山堂类辨》有生动的描述:“庭前植荷叶、紫苏数茎,见百合花昼开夜合,紫苏叶朝挺暮垂,因悟草木之性,感天地阴阳之气而为开阖也;昼开夜合,朝出暮入,一日之开阖也”。其配伍体现了中医“整体观念,天人相应”的理论精髓。
中医认为失眠的病因是肝郁气滞,心气耗伤,心失所养,神失所藏,则心神不安,失眠不寐;忧思郁结于心,热扰心神,心血亏虚,血不养神,故治疗宜疏肝理气、养心安神。苏叶跟百合同用,可以起到疏肝解郁、清心安神的功用。苏叶能够散表邪、发汗,用于风寒感冒,还可用于恶心、呕吐,脾胃气滞,出现胸闷,苏叶有宽中理气的功用,苏叶可以解鱼蟹毒;而百合是养阴清胃,且有安神作用,用于失眠、多梦、精神恍惚,也可用于虚烦、心悸病症。苏叶与百合一个是调理胃肠、行气宽中,另一个是养阴润肺、清心安神的作用。
百合苏叶汤作为汤剂,煎煮操作繁琐,不易保存,必须现煎,并且汤剂剂量较大,味苦涩,不易入口。同时,原方中百合归心肺经,紫苏归肺脾经,对于不寐之症,仅适合于心烦失眠,原方还是具有一定的局限性。
发明内容
本发明的目的是针对现有治疗失眠药物的不足,提供一种用于安神助眠的药茶,用以调节失眠人群精神情绪,提高其睡眠质量,达到良好的助眠效果。
本发明所述用于安神助眠的药茶是在传统百合苏叶汤的基础上进行改良,由以下重量份数的中药为原料药制备获得的袋泡茶剂:百合2~5份,酸枣仁0.5~2份,紫苏叶0.5~2份,山楂0.5~2份。
进一步地,本发明所述用于安神助眠的药茶优选是由以下重量份数的中药为原料药制备获得的袋泡茶剂:百合3份,酸枣仁1份,紫苏叶1份,山楂1份。
进一步地,本发明还提供了所述用于安神助眠的药茶的制备方法,是将所述重量份数的酸枣仁加水煎煮2~3次,每次加8~12倍重量的水,煎煮时间1~2h,合并水煎液,浓缩得到干浸膏,再将所述重量份数的百合、紫苏叶和山楂粉碎过药典一号筛,与所述干浸膏混合,装袋制成袋泡茶剂。
优选地,本发明是采用减压浓缩的方法对酸枣仁水煎液进行浓缩。具体是将酸枣仁水煎液在真空度-0.08~-0.09mpa、60℃下减压浓缩至酸枣仁水煎液近干后,于80℃烘箱内烘干得到干浸膏。
更进一步地,本发明在制成的袋泡茶剂中还可以加入或不加冰糖。
本发明用于安神助眠的药茶是在保留原有百合苏叶汤配伍理论的情况下稍作修改,全部采用药食同源中药制备得到了一种用于改善睡眠的药茶。经实验验证,本发明药茶虽然没有直接睡眠作用,但却可以起到良好的助眠作用,能对亚健康人群失眠患者起到有效的干预作用,使患者的睡眠质量得到有效改善,为失眠患者提供了一种理想的改善方式。
失眠一证,虽有诸多病因病机,但其病理变化总属阴阳失交,阳不入阴。故而本发明主要选择了交通阴阳功效的药物,如百合的昼开夜合,紫苏的朝出暮入。
本发明重用百合为君药,酸枣仁为臣药,佐使分别为紫苏叶和山楂。百合其味甘,性微寒而润,入心肺之经,有养阴润肺,清心安神之功效;《血证论》载:“肝病不寐者,肝藏魂,人寤则魂游于目,寐则魂返于肝,若阳浮于外,魂不入肝,则不寐”;因此治疗不寐以入肝经的药物为重。紫苏叶疏肝解郁,宽胸下气,与百合相合,清心安神,开宣胸脘;酸枣仁性味甘平,养心阴,益肝血而宁心安神,为养心阴安神之要药,与百合苏叶相配以增强其宁心安神功效;此外《万病回春》中说:“胃气弱则百病生,脾阴足而万邪息,调理脾胃为医中之王道”,调和气血,顾护脾胃也是平衡阴阳的一要,本发明用山楂入肝脾胃经,酸甘化阴,有助于阳入于阴,交通心肾,水火既济,收敛神气,顾护脾胃,行气散瘀,标本兼顾。
本发明一则养肺阴以清心神,一则疏肝郁以除虚烦,再有理脾胃而调节后天之本,治标治本,共奏清心安神养心补肝之效。本发明组方攻补兼施、升降相宜,以阴阳平衡为主治,调和阴阳为目的,调节周身,调理不寐之证。
不寐症多以情志失调,阴阳不合为主,故临证多从肝论治。本发明中酸枣仁与山楂皆归肝经,益肝血而宁心安神顾护脾胃,弥补了原方只是清心肺阴虚内热而安神,只能够治疗心烦所引起失眠的局限性。
进而,原方中的百合苏叶汤为汤剂,煎煮操作繁琐,不易保存,必须现煎,并且汤剂剂量较大,味苦涩,不易入口。本发明的安神助眠药茶加入了酸枣仁和山楂两味药,不仅在增强疗效的同时,兼顾调理脾胃,促进消化,并且还可以改善药物的苦涩口感,增强依存性。
本发明组方中,百合、酸枣仁、山楂所含活性成分多为皂苷类、多糖类、黄酮类及有机酸类等,皆可溶于热水;紫苏叶的化学成分尚不明确,但有研究表明其水提液有药理活性。因此,本发明采用袋泡茶的方式,将其以水冲泡,即可将药效成分溶出,不仅需饮服的剂量小,方便快捷,而且不需要添加矫味剂、稳定剂等辅料,实际冲泡为黄棕色或红棕色澄清液体,气清香,味微酸,可以被大部分人群所接受,并具有显著功效。
具体实施方式
下面结合实施例对本发明的具体实施方式作进一步的详细描述。以下实施例仅用于更加清楚地说明本发明的技术方案,从而使本领域技术人员能很好地理解和利用本发明,而不是限制本发明的保护范围。
本发明实施例和应用例中涉及到的实验方法、生产工艺、仪器以及设备,其名称和简称均属于本领域内常规的名称,在相关用途领域内均非常清楚明确,本领域内技术人员能够根据该名称理解常规工艺步骤并应用相应的设备,按照常规条件或制造商建议的条件进行实施。
本发明实施例和应用例中使用的各种原料或试剂,并没有来源上的特殊限制,均为可以通过市售购买获得的常规产品。也可以按照本领域技术人员熟知的常规方法进行制备。
实施例1。
称取1kg酸枣仁,加入8kg水中浸泡30min,加热回流提取1.5h,过滤出滤液,滤渣再加入同样量的水煎煮,共煎煮3次,合并煎液,减压浓缩,得到干浸膏160~180g。
称取3kg百合,粉碎成药典规定的最粗粉;称取1kg紫苏叶,揉碎过药典一号筛;称取1kg山楂,破碎成药典规定的最粗粉。
将上述紫苏、百合、山楂粉末与酸枣仁干浸膏混合均匀,加入3kg冰糖,装入规格7×9cm的玉米纤维袋中,获得袋泡茶,每袋9g。
实施例2。
称取2kg酸枣仁,加入20kg水中浸泡30min,加热回流提取3h,过滤出滤液,滤渣再加入同样量的水煎煮,共煎煮2次,合并煎液,减压浓缩,得到干浸膏300~350g。
称取5kg百合,粉碎成药典规定的最粗粉;称取1kg紫苏叶,揉碎过药典一号筛;称取2kg山楂,破碎成药典规定的最粗粉。
将上述紫苏、百合、山楂粉末与酸枣仁干浸膏混合均匀,加入5kg冰糖,装入规格10×12cm的玉米纤维袋中,获得袋泡茶,每袋15g。
应用例1。
按照实施例1的药物配比,将原料药煎煮制备成与袋泡茶具有相同药效的安神助眠药液,以其进行动物实验,以验证本发明用于安神助眠的药茶直接改善睡眠的功效。
试验动物采用BALB/c 4周龄雄性SPF级小鼠,24只,体重19~23g,购自斯贝福(北京)生物技术有限公司,No.110324210101384853。
根据小鼠体重,将24只小鼠随机分为空白组、安神助眠药茶低、中、高剂量组,每组6只。分组完成后,用苦味酸标记。
按照人与动物的体表面积折合剂量计算,确定安神助眠药茶的给药剂量分别为低剂量组4.68g/kg,中剂量组23.4g/kg,高剂量组46.8g/kg。
取安神助眠药液,分别配制成浓度为0.234g/mL、1.17g/mL、2.34g/mL的药液,用于灌胃各组小鼠,每天一次,剂量为0.1mL/10g,连续30天;空白组给予相同剂量的生理盐水,进行小鼠直接睡眠实验,记录空白组和各剂量给药组的睡眠小鼠数量和睡眠时间,考察安神助眠药茶对于小鼠睡眠的作用效果。
如果翻正反射消失,且在1min之内不能恢复,则认为小鼠入睡;翻正反射恢复,小鼠能立即翻身即认为小鼠觉醒。并将此期间的这段睡眠时间确定为小鼠的持续睡眠时间。
实验结果显示,安神助眠药茶低、中、高剂量组均无小鼠入睡,但是高剂量组小鼠出现活动迟缓现象,中、低剂量组小鼠与空白组对照活动没有影响。
结果表明,安神助眠药茶低、中、高剂量组小鼠在给予药物之后,均未出现翻正反射消失现象,各剂量安神助眠药茶对小鼠直接睡眠影响可以忽略不计,均无直接睡眠作用。
应用例2。
使用安神助眠药液进行动物实验,以验证本发明用于安神助眠的药茶对诱导小鼠睡眠的影响。
1、延长戊巴比妥钠诱导的小鼠睡眠时间试验。
本实验是在戊巴比妥钠催眠的基础上,观察受试物是否能延长睡眠时间,若睡眠时间延长,则说明受试物与戊巴比妥钠有协同作用。
在进行正式实验之前进行预实验,以确定能够使动物100%入睡,但又不使睡眠时间过长的戊巴比妥钠剂量,并以此剂量进行正式实验。经预实验验证,小鼠注射戊巴比妥钠45mg/kg为宜。
按照应用例1,针对空白组和安神助眠药茶低、中、高剂量组小鼠分别进行灌胃给药和生理盐水,并在最后一次给药后1h,各组小鼠腹腔注射45mg/kg戊巴比妥钠,注射量为0.1mL/10g。
将从1min内翻正反射消失到30s内翻转3次的时间间隔视为睡眠时间,观察给予本发明安神助眠药茶后对延长戊巴比妥钠诱导小鼠睡眠时间的影响。
注:与空白组比较,*P<0.05,**P<0.01。
根据表1结果可以得出,与空白组比较,本发明安神助眠药茶低、中、高剂量组均能延长戊巴比妥钠诱导小鼠的睡眠时间,且影响极其显著(P<0.01)。
2、阈下剂量戊巴比妥钠睡眠发生率试验。
本实验的目的是观察受试物与戊巴比妥钠的协同作用。
由于戊巴比妥钠通过肝酶代谢,而对该酶有抑制作用的药物,也能延长戊巴比妥钠睡眠时间,所以为排除这种影响,应进行阈下剂量试验。
在正式实验前先进行预实验,确定戊巴比妥钠阈下催眠剂量,即80~90%小鼠翻正反射不消失的戊巴比妥钠最大阈下剂量。经过预实验,最终确定正式实验时戊巴比妥钠用量为30mg/kg。
按照应用例1,针对空白组和安神助眠药茶低、中、高剂量组小鼠分别进行灌胃给药和生理盐水,并在最后一次给药后1h,各组小鼠腹腔注射30mg/kg戊巴比妥钠,注射量为0.1mL/10g。
各组腹腔注射戊巴比妥钠后,记录30min内入睡的小鼠数量,观察安神助眠药茶能否改善戊巴比妥钠阈下睡眠的发生率。
表2结果显示,与空白组相比,低、中、高剂量组小鼠睡眠发生率都有所增高,高剂量组催眠效果最为明显,睡眠发生率为66.7%。说明在阈下戊巴比妥钠睡眠剂量下,安神助眠药茶对小鼠睡眠具有良好的诱导作用。
3、巴比妥钠睡眠潜伏期试验。
相对于戊巴比妥钠,巴比妥钠可以使受试动物有更长的睡眠潜伏期,因此睡眠潜伏期实验采用长效镇静催眠药巴比妥钠进行。
本实验的目的是在巴比妥钠催眠的基础上,观察受试物是否能缩短入睡潜伏期,若睡眠潜伏期缩短,则说明受试物与巴比妥钠有协同作用。
在正式实验前进行预实验,确定使动物100%入睡,但又不使睡眠时间过长的巴比妥钠剂量,用此剂量正式实验。经预实验,巴比妥钠的实验剂量定为300mg/kg。
按照应用例1,针对空白组和安神助眠药茶低、中、高剂量组小鼠分别进行灌胃给药和生理盐水,并在最后一次给药后1h,各组小鼠腹腔注射300mg/kg巴比妥钠,注射量为0.1mL/10g。
各组腹腔注射巴比妥钠后,观察灌胃安神助眠药茶的小鼠对腹腔注射巴比妥钠后的睡眠潜伏期是否有影响。
注:与空白组比较,*P<0.05,**P<0.01。
根据表3结果可以得出,与空白组比较,安神助眠药茶低、中、高剂量组均能缩短小鼠的巴比妥钠睡眠潜伏期,其中,低、中剂量影响显著(P<0.05),高剂量影响极显著(P<0.01)。
4、神经递质含量测定试验。
按照应用例1,针对空白组和安神助眠药茶低、中、高剂量组小鼠分别进行灌胃给药和生理盐水,在各组小鼠最后一次灌胃给药后禁食不禁水24h,然后迅速脱颈处死并取出脑组织,以4℃生理盐水漂洗,滤纸拭干后称重;加入到冷的生理盐水中,于匀浆管中充分研磨,制成10%的脑组织匀浆,4000r/min离心10min,取上清液,分别检测脑组织中的GABA、Ach、NE、5-HT和DA含量。
注:与空白组比较,*P<0.05,**P<0.01。
安神助眠药茶低、中、高剂量组均可增加正常小鼠脑中NE、5-HT、DA、GABA及Ach的含量。与空白组相比,高剂量的安神助眠药茶对于小鼠脑中神经递质含量的影响最大。研究结果表明,安神助眠药茶可能是通过调节脑中NE、5-HT、DA、GABA及Ach的含量达到改善睡眠的作用。
上述应用例动物试验结果显示,本发明安神助眠药茶对于改善小鼠睡眠具有一定的效果。低、中、高剂量药茶单独使用时无直接睡眠作用,但能延长戊巴比妥钠诱导的睡眠时间,增加戊巴比妥钠诱导的阈下睡眠发生率,缩短巴比妥钠诱导的睡眠潜伏期,使小鼠活跃度呈现明显的下降趋势,对于改善小鼠睡眠有一定的效果。
本发明以上实施例并没有详尽叙述所有的细节,也不限制本发明仅为以上所述实施例。本领域普通技术人员在不脱离本发明原理和宗旨的情况下,针对这些实施例进行的各种变化、修改、替换和变型,均应包含在本发明的保护范围之内。
Claims (5)
1.一种用于安神助眠的药茶,是由以下重量份数的中药为原料药制备获得的袋泡茶剂:百合2~5份,酸枣仁0.5~2份,紫苏叶0.5~2份,山楂0.5~2份。
2.根据权利要求1所述的用于安神助眠的药茶,是由以下重量份数的原料药制备获得的袋泡茶剂:百合3份,酸枣仁1份,紫苏叶1份,山楂1份。
3.权利要求1或2所述用于安神助眠的药茶的制备方法,是将所述重量份数的酸枣仁加水煎煮2~3次,每次加8~12倍重量的水,煎煮时间1~2h,合并水煎液,浓缩得到干浸膏,再将所述重量份数的百合、紫苏叶和山楂粉碎过药典一号筛,与所述干浸膏混合,装袋制成袋泡茶剂。
4.根据权利要求3所述的用于安神助眠的药茶的制备方法,其特征是将酸枣仁水煎液在真空度-0.08~-0.09mpa、60℃下减压浓缩至酸枣仁水煎液近干后,于80℃烘箱内烘干得到干浸膏。
5.根据权利要求3所述的用于安神助眠的药茶的制备方法,其特征是在制成的袋泡茶剂中加入或不加冰糖。
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