CN116509971A - 一种具有益智效果的中药组方、中药液和药物制剂 - Google Patents
一种具有益智效果的中药组方、中药液和药物制剂 Download PDFInfo
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Abstract
本发明公开了一种具有益智效果的中药组方、中药液和药物制剂,由以下原料药制成:当归、远志、生地、菟丝子、五味子、石菖蒲、龙骨、川芎、地骨皮、藏青果、毛诃子、余甘子、知母、红景天、西洋参、甘草、茯苓、酸枣仁、当归、灵芝、合欢皮、百合、山药、柏子仁、女贞子、丹参、泡参、黄精、牡蛎、龙眼肉、龟甲胶和益智仁,根据中医理论“君臣佐使”的组方原则,精心搭配的特殊配方,主治健忘,增强记忆力;提高大脑供血供氧,抗疲劳,耐缺氧而达到提升学习专注度,改善学习注意力不能集中的现象,提高机体的应激能力;具有补益心肾,益智安神的功效,用于心肾不交所致的健忘、神疲体倦、反应迟鈍、失眠;经过长期临床验证,功效得到了临床验证。
Description
技术领域
本发明涉及中药食品、保健品领域,尤其涉及一种具有益智效果的中药组方、中药液和药物制剂。
背景技术
儿童及青少年是家庭和社会的未来,而智力是其生长发育中最重要的要素之一,是每个家庭最为关注的事情。学习能力是获得和运用知识的能力,它是感知、认知、自控力、理解、记忆、操作能力等诸多能力的综合体现。
学习能力更多与智力和反应能力相关,中医认为智力不足或智力减退多与心脾两虚、阴虚火旺、心肾不交、痰饮淤血等因素有关,故多以具有补虚益气、益脾补肾、祛痰开窍、活血去瘀、安神益智等功效的中药,如人参、黄芪、三七、灵芝、远志、益智仁、山药等进行复配以发挥益智作用,但往往在辨证施治上靶向缺失较为明显,入方中药协同机制不清,且质量控制及成本控制困难加大,如公开号为CN102552625B的中国专利公开了一种抗衰老益智中药及其制备方法,该中药组方由以下原料组成:人参、制首乌、黄芪、三七、刺五加、灵芝、枸杞子、远志、红薯干、芝麻油和怀山药。西医对因大脑损伤所至失智、失能患者的治疗,主要在降脂降压、扩张血管、改善循环、促进代谢以及神经能因子诱导等方法着手,但疗效总体欠佳,在治疗手段上有较为明显的局限性。
因此本领域技术人员致力于开发一种具有健脑益智效果的中药组方、中药液和药物制剂。
发明内容
有鉴于现有技术的上述缺陷,本发明所要解决的技术问题是提供一种具有益智效果的中药组方、中药液和药物制剂。
为实现上述目的,本发明提供一种具有益智效果的中药组方,由以下重量份的原料药制成:远志175~185份、生地95~105份、菟丝子95~105份、五味子145~155份、石菖蒲145~155份、龙骨95~105份、川芎145~155份、地骨皮95~105份、藏青果75~85份、毛诃子75~85份、余甘子75~85份、知母145~155份、红景天115~125份、西洋参145~155份、甘草45~55份、茯苓95~105份、酸枣仁145~155份、当归145~155份、灵芝85~95份、合欢皮95~105份、百合115~125份、山药145~155份、柏子仁45~55份、女贞子45~55份、丹参145~155份、泡参115~125份、黄精145~155份、牡蛎145~155份、龙眼肉95~105份、龟甲胶95~105份和益智仁145~155份。
优选地,所述中药组方由以下重量份的原料药制成:远志175~180份、生地95~100份、菟丝子95~100份、五味子145~150份、石菖蒲145~150份、龙骨95~100份、川芎145~150份、地骨皮95~100份、藏青果75~80份、毛诃子75~80份、余甘子75~80份、知母145~150份、红景天115~120份、西洋参145~150份、甘草45~50份、茯苓95~100份、酸枣仁145~150份、当归145~150份、灵芝85~90份、合欢皮95~100份、百合115~120份、山药145~150份、柏子仁45~50份、女贞子45~50份、丹参145~150份、泡参115~120份、黄精145~150份、牡蛎145~150份、龙眼肉95~100份、龟甲胶95~100份和益智仁145~150份。
优选地,所述中药组方由以下重量份的原料药制成:远志180~185份、生地100~105份、菟丝子100~105份、五味子150~155份、石菖蒲150~155份、龙骨100~105份、川芎150~155份、地骨皮100~105份、藏青果80~85份、毛诃子80~85份、余甘子80~85份、知母150~155份、红景天120~125份、西洋参150~155份、甘草50~55份、茯苓100~105份、酸枣仁150~155份、当归150~155份、灵芝90~95份、合欢皮100~105份、百合120~125份、山药150~155份、柏子仁50~55份、女贞子50~55份、丹参150~155份、泡参120~125份、黄精150~155份、牡蛎150~155份、龙眼肉100~105份、龟甲胶100~105份和益智仁150~155份。
优选地,所述中药组方由以下重量份的原料药制成:远志180份、生地100份、菟丝子100份、五味子150份、石菖蒲150份、龙骨100份、川芎150份、地骨皮100份、藏青果80份、毛诃子80份、余甘子80份、知母150份、红景天120份、西洋参150份、甘草50份、茯苓100份、酸枣仁150份、当归150、灵芝90、合欢皮100份、百合120份、山药150份、柏子仁50份、女贞子50份、丹参150份、泡参120份、黄精150份、牡蛎150份、龙眼肉100份、龟甲胶100份和益智仁150份。
以上组成是按重量作为配比的,在生产时可按照比例增大或减少,如大规模生产可以以公斤为单位,或以吨为单位,小规模的生产可以以克为单位,重量可以增大或者减小,但各组成之间的生药材重量配比的比例不变。
根据本发明的另一个方面,本发明还提供一种具有益智效果的中药液,所述中药液是由上述的中药组方通过水煎煮的方法获得,按照全部所述原料药重量之和的3至5倍计算加水总量,分两次进行煎药。
进一步,所述中药液的制备方法如下所示:
(1)浸泡:将以下原料药:远志、生地、菟丝子、五味子、石菖蒲、龙骨、川芎、地骨皮、藏青果、毛诃子、余甘子、知母、红景天、西洋参、甘草、茯苓、酸枣仁、当归、灵芝、合欢皮、百合、山药、柏子仁、女贞子、丹参、泡参、黄精、牡蛎和龙眼肉放入加水总量的60%的清水中浸泡2小时;
(2)煎煮:先用武火烧开后,改用中火煎煮0.5小时,再加入益智仁煎煮0.5小时,倒出药汁;剩余药渣加入剩余水量进行第二次煎药,同样先用武火烧开后改用中火煎煮45分钟,倒出药汁;在此步骤中由于益智仁含有芬香挥发油,为了确保益智仁的药效发挥,所以在此时加入而不是与之前原料药同时浸泡煎煮;
(3)静置、过滤:将两次药汁合并混合均匀,将合并的药汁静置3小时,用200目的滤网过滤药汁;过滤药汁再静置2小时,再次过滤药汁;
(4)浓缩:将过滤好的药汁先用武火烧开后,改用中火继续浓缩至过滤好的药汁体积的40~42%,加入龟甲胶后改用文火浓缩至过滤好的药汁体积的36~38%。
更进一步,在步骤(4)之后还包括步骤(5)添加矫味剂,所述矫味剂为甜味剂、芳香剂、胶浆剂和泡腾剂中的一种或多种的组合。
所述甜味剂为蔗糖、单糖浆、橙皮糖浆、枸橼糖浆、樱桃糖浆、甘草糖浆、桂皮糖浆、甜菊苷、甘油、山梨醇、甘露醇、糖精钠、蛋白糖和纽糖中的一种或多种的组合。甜味剂能掩盖药物的涩和苦味。
芳香剂为柠檬、茴香、薄荷油、苹果香精、桔子香精和香蕉香精中的一种或多种的组合。芳香剂在药剂中用以改善药剂的气味。
胶浆剂为海藻酸钠、***胶、明胶、甲基纤维素和羧甲基纤维素钠中的一种或多种的组合。胶浆剂具有粘稠缓和的性质,可干扰味蕾的味觉而具有矫味的作用。
更进一步,所述矫味剂为泡腾剂和甜味剂的组合,所述泡腾剂为小苏打粉,所述甜味剂为纽糖,先加入小苏打粉,待药汁内泡沫散尽时,加入纽糖。之所以需等到药汁内泡沫散尽时才加入纽糖是因为药汁中有大量的有机酸类物质,这是药物酸味的主要原因,加入小苏打粉后,酸碱中和过程会产生大量泡沫,其是有机酸类物质形成有机酸钠盐,而碳酸根被置换成碳酸,碳酸分解成二氧化碳气体从药汁中挥发出来,而产生大量的泡沫,这样纽糖加入后就不会与有机酸类物质产生反应,确保纽糖的甜味保持在药汁里。
更进一步,按重量份算,所述小苏打粉2~10份,所述纽糖1~6份。
更进一步,在步骤(5)之后还包括步骤(6)添加防腐剂,所述防腐剂为山梨酸钾,按重量份算,所述山梨酸钾1~10份。
更进一步,在步骤(6)之后还包括步骤(7)灌装,待药汁浓缩至过滤好的药汁体积的34~35%时得到浓缩液,停止加热,待药汁温度下降至60℃时,将浓缩液置于膏体灌装机内,灌装至已消毒的口服液瓶中。
更进一步,所述龟甲胶用粉碎机打成粉末使用,确保龟甲胶溶解更完全,在药汁中分布更均匀。
更进一步,所述藏青果、毛诃子和益智仁分别用研钵捣破使用,确保藏青果、毛诃子和益智仁的有效成分能充分溶在药汁中。
根据本发明的又一个方面,本发明还提供一种具有益智效果的药物制剂,所述药物制剂是将上述的中药液加入药剂学上常用的辅料制备而成。可用于本发明的药剂学上常用的辅料包括但不限于药学上可接受的载体、稀释剂、赋形剂、佐剂、缓冲剂、pH调节剂、防腐剂、抗氧化剂、抑菌剂、稳定剂、悬浮剂、增溶剂、表面活性剂(例如润湿剂)、着色剂和致等渗(isotonicizing)溶质。适当的载体、稀释剂、赋形剂等可以在标准药学书籍中找到。参见,例如药物添加剂手册(Handbook of Pharmaceutical Additives),第二版(编者M.Ash和I.Ash),2001(Synapse Information Resources,Inc.,Endicott,New York,USA);Remington′s Pharmaceutical Science,第18版,Mack Publishing Company,Easton,Pa.,1990;以及药物赋形剂手册(Handbook of Pharmaceutical Excipients),第二版,1994。
进一步的,所述药物制剂的剂型属于内服药物剂型。
进一步的,所述内服药物剂型包括糖衣片剂、薄膜衣片剂、肠溶衣片剂、胶囊剂、口服液、糖浆剂、***剂、颗粒剂、滴丸剂、散剂、膏剂、混悬剂、粉剂。
制备前面所述的药物制剂的生产工艺是本领域技术人员熟知的。
本发明的有益效果是:本发明是根据中医膏方理论“君臣佐使”的组方原则,精心搭配的特殊配方,以读书丸(远志、石菖蒲、菟丝子、生地黄、地骨皮、五味子、酸枣仁、当归、川芎)为君方,主治健忘,增强记忆力;臣以三勒浆方(藏青果、毛诃子、余甘子、红景天、西洋参),抗疲劳、耐缺氧、免疫力调节,以助增强记忆之功,提高大脑供血供氧,提升学习专注度,改善学习注意力不能集中的现象;臣以孔圣枕中汤(龟甲胶、龙骨、远志、石菖蒲、灵芝)具有补益心肾,益智安神的功效,用于心肾不交所致的失眠、健忘,神疲体倦,以增强君方主治健忘之效;佐以酸枣汤(酸枣仁、川芎、知母、茯苓、甘草、龙眼肉、牡蛎)一则增强君方治健忘之功;二则有养血镇静安神、清热除烦的功效,适用于肝血不足、压力过大而引起的失眠。再佐以益智仁温脾,暖肾,益智;佐以百合、柏子仁、泡参清心安神,以助记忆;佐以山药,黄精、女贞子补肾滋阴健脑;佐以合欢皮,丹参活血通脉,解郁安神;使药为甘草,调和诸药,并矫味;使全方补中有清,补而不滞。经过长期的临床验证,其功效得到了临床验证。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白,以下结合实施例,对本发明进行进一步详细说明。应当理解,此处所描述的具体实施例仅仅用以解释本发明,并不用于限定本发明。
本说明书中公开的所有特征,或公开的所有方法或过程中的步骤,除了相互排斥的特质和/或步骤以外,均可以以任何方式组合,除非特别叙述,均可被其他等效或具有类似目的的替代特征加以替换,即,除非特别叙述,每个特征之一系列等效或类似特征中的一个实施例而已。
中药何以能补脑益智,传统中医有诸多论述,从以下几个方面来研讨,可以略窥其机理。补脑与益智中医认为构成大脑实质的物质就是“髓”,人脑由髓汇集而成,如《灵枢·海论》说:“脑为髓之海,,《素间·五脏生成篇》说:“诸髓者,皆属于脑”。而“人之记忆皆在脑中”,故补脑可以增强记忆。《神农本草经》载胡麻仁有“补脑髓”和“耳目聪明”的功能,《日华子本草》和《雷公炮制药性解》均记载其“益脑髓,明耳目”。清·王清任指出:“灵机记性在脑中,因饮食生气血,长肌肉,精汁之清者,化而为髓,由脊髓上行入脑,名日脑髓。两耳通脑,所听之声归于脑;两目系如线长于脑,所见之物归脑;鼻通于脑,所闻香臭归于脑。小儿周岁脑渐生,舌能言一二字”。讲到脑髓的逐渐充实,幼儿才开始言语、理解等智力活动,因为脑髓的正常工作,才有视觉、听觉、嗅觉等感觉知觉方面的初步智力活动。可见补益脑髓中药,可以增益智慧。
另外,在脑髓的形成和发展过程中,脊髓显得尤为重要,脊髓是连接头脑和全身、不断供给大脑营养的通道,而脊髓也正是督脉的位置所在。《难经·二十八难》说:“督脉者,起于下极之俞,并于脊里,上至风府,入属于脑”。对输送精髓达脑有重要作用,“故上至脑,下至尾底,皆精髓升降之路也”(《医学入门》)。因此,填补督脉精髓,以补脑益智,也是中药补脑益智的重要思路。如前人认为采用鹿茸、鹿角、龟版、补髓丹等方药,均有直接填补督脉之髓而补脑益智的作用。
养心与益智中医理论的特点之一就是整体观念。传统中医对脑功能的认识,也着眼于整体学说。把脑的功能分归于五脏,其中心最为重要。更侧重于指人脑的思维智力活动。如《灵枢·本神》说:“所以任物者谓之心”,认为人们接受外来事物而发生的思维活动过程,是由心来完成的。
正因为有此认识,中医主张通过安心神、补心血、益心气、清心热等方法来加强人的思维活动,故有养心可以益智的观点。由于心主神明,故通过安心神而益智的方药很多,如五味子、镇心丹等。心又主血脉,血液是神志活动的主要物质基础。心血充盈,则神志清晰,思维敏捷,就会表现出良好的智力状态;如心血不足,常可导致心神的病变,出现失眠、多梦、健忘等症,损及智力活动。此时就要补心血以益智,如当归、地黄、首乌、天王补心丹等。血在脉内运行不息,供养大脑及全身,还依赖于心气的推动,心气旺盛,则血脉充盈,才能保证“主神”功能的正常发挥多倘若心气不足,心血亏少,或血行不畅,就会出现精神思维方面的低下和紊乱。此时就要益心气以益智,如党参、黄芪、人参养荣汤、扶元散等。
补肾与益智脑位于颅内,由髓汇集而成,那么髓又是怎样产生的呢?《灵枢·经脉》指出:“人始生,先成精,精成而后脑髓生”。认为脑髓来源于人的先天之精,即父母的生殖之精,而肾主生殖,生殖之精实为肾脏所司,故脑髓的形成和发育,与肾的功能关系极为密切。先天生殖之精是形成脑髓的基本物质,而后天之精是不断充实脑髓的营养源泉。后天之精即是五脏六腑之精,由肾藏之,正如《素间·上古天真论》所言:“肾者主水,受五脏六腑之精而藏之”。肾精充足,则骨髓生化有源,骨髓充盛,则脑得健旺,精力充沛,强劲有力,耳目聪明,强记不忘;肾精亏虚,则精髓不足,脑海空虚,技巧实践能力就差,健忘失眠,神呆衰老随之而来。故《灵枢·海论》说:“髓海有余,则轻劲有力,自过其度,髓海不足,则脑转耳鸣,胫疫眩冒,目无所见,懈怠安卧”。从上可知,中医强调补肾以益智就不难理解。从补肾填精着手,再生髓益脑,以达增强智慧之目的,是中药益智的重要法则之一。古人谓欲补脑之髓,必先补肾中之精,即是此意。
基于以上理论,本发明方案从益智健脑,养血安神和主治心肾亏虚三方面针对下药,故采用以下原料药:
远志:药性苦、辛,温。归心、肾、肺经。远志药性辛散苦泄温通,入心、肺、肾经。既助心阳、益心气,使肾气上交于心而安神益智,又祛痰而开窍,善治心神不安或痰阻心窍诸证。本品含皂苷,还含远志酮、生物碱、远志醇、细叶远志定碱、脂肪油、树脂等成分。具有安神益智,交通心肾,祛痰,消肿的功效。同时也具有增强学习记忆能力,镇静安神和抗抑郁的作用,具体参考资料为【1】韩晗,张智华,曹秋实,吕银娟.远志的药用分析[J].中医药导报,2018,24(24):127-129。【2】邸学,刘雅晴,田盛,张晓博,王海波.远志多指标成分活性效应质量评价研究[J].辽宁中医药大学学报.Vol.24No.4Apr.,2022。
生地:(地黄属植物)一般指地黄,生地黄味甘,性寒,归心、肝、肾经。功效淸热凉血,养阴生津。本品始载于《神农本草经》,列为上品:“主折跌绝筋,伤中。逐血痹,填骨髓,长肌肉。作汤,除寒热积聚,除痹。”地黄中化学成分主要有低聚糖、多糖、环烯醚萜苷、氨基酸等,所以同时也具有促进造血、增强学习记忆能力和改善造血功能的能力,具体参考资料为【3】刘卫欣,卢兖伟,杜海涛,吴祖泽.地黄及其活性成分药理作用研究进展[J].国际药学研究杂志2009年8月第36卷第4期。
菟丝子:味辛、甘,平,归肝、肾、脾经。菟丝子甘补辛润,性平偏温,平补阴阳,并兼固涩。入肾经,善补阳益阴、固精缩尿,治肾虚阳痿、遗精尿频、带下等;入肝、脾经,善养肝明目、补脾止泻,治目暗不明、脾虚泄泻。此外,通过补益肝肾还能安固胎元,通过调补阴阳还能生津止渴,治肾虚胎动不安、消渴。主要含有黄酮类、有机酸类等成分,还含钙、钾、磷等微量元素及氨基酸。同时也具有改善脑缺血的能力,具体参考资料为【4】王焕江,赵金娟,刘金贤,王磊,林建强,林慧彬.菟丝子的药理作用及其开发前景[J].中医药学报.Vol.40,No.6,2012。
五味子:药性酸、甘,温,归肺、心、肾经。五味子酸敛质润温补,敛、补兼备,入肺、肾、心经。上能敛肺止咳平喘,下能滋肾涩精止泻,内能生津宁心安神,外能固表收敛止汗。五味俱备,唯酸独胜;虽曰性温,但质滋润;敛补相兼,节流增援。药力较强,为补虚强壮收涩之要药。同时也具有改善睡眠和改善脑组织功能的作用,具体参考资料为【5】刘杰,徐剑,郭江涛.五味子活性成分及药理作用研究进展[J].中国实验方剂学杂志.Vol.25,No.11Jun.,2019。【6】任海风,王世华.五味子药理作用研究进展[J].中国医院用药评价与分析.Vol.18No.8,2018。
石菖蒲:药性辛、苦,温。归心、胃经。石菖蒲辛散香窜,苦燥温化,归心、胃经。既善化痰湿、开窍闭,治痰湿蒙闭心窍诸证;又能宁心神、和胃气,治心气亏虚之心悸失眠、健忘恍惚,以及湿浊中阻与噤口痢等证。同时也具有改善空间认知能力和增强学习记忆的能力,具体参考资料为【7】郭俊和,陈云波,魏刚,聂慧,周莹,程淑意,王奇,陈东风.石菖蒲活性成分及其不同比例配伍对痴呆小鼠学习记忆功能的影响[J].中药新药与临床药理.2012March,Vol.23,No.2。
龙骨:味涩、甘,性平。归心、肝、肾经。镇心安神,平肝潜阳,固涩,收敛。用于心悸怔忡,失眠健忘,惊痫癫狂,头晕目眩,自汗盗汗,遗精遗尿,崩漏带下,久泻久痢,溃疡久不收口及湿疮。龙骨主治颇广,但不离其收摄浮越之气,性涩去脱固气之功。心腹鬼注、精物老魅、小儿热气惊痫、夜梦鬼交为神志浮越不宁所致,龙骨可敛神镇逆而安心神、定魂魄。具体参考资料为【8】李嫣然,陈丽云.龙骨的本草考证[J].辽宁中医药大学学报.Vol.24,No.9,Sep.,2022。
川芎:药性辛,温。归肝、胆、心包经。川芎辛香行散温通,入肝、胆、心包经。上行头颠,下走血海,内行血气,外散风寒。活血力强,治血瘀气滞诸痛,兼寒者最宜,被前人誉为“血中之气药”。治多种头痛,属风寒、血瘀者最佳;属风热、风湿、血虚者,亦可选,故前人有“头痛不离川芎”之言。同时具有增强细胞活力、改善学习记忆能力和提高多巴胺神经元的存活率的能力,具体参考资料为【9】邻秘,徐世军,代渊.川芎活性成分改善神经退行性疾病药理[J].环球中医药.August 2022,Vol.15,No.8。
地骨皮:味苦;性寒。归肝、肾、大肠、胃经。治热毒血痢,肠风下血,黄疸,赤白带下,小儿肺炎,疳积,急性扁桃体炎,痔漏,脱肛,皮肤瘙痒,疥癞恶疮,阴疮湿痒,瘰疬,烫伤。外治滴虫性***炎。现代药理研究发现,地骨皮中的甜菜碱可以通过抑制大鼠心肌组织RhoA、ROCK1、ROCK2蛋白表达的升高,改善心肌组织坏死、炎细胞浸润及间质水肿来保护通过ISO诱导的大鼠急性心肌缺血损伤。
藏青果:酸苦涩,微寒。入肺、胃等经。清热生津,解毒涩肠。治肺炎,痢疾,阴虚白喉。解乌头毒。其具有一定抗氧化活性作用,具体参考资料为【10】赵鸿燕,刘芳,谢永红,戴青,刘松青.西青果丙酮及水提取物体外抗氧化活性初步研究[J].第三军医大学学报,2017,39(9)。
毛诃子:性平,味甘、涩。归经无。清热解毒、收敛养血、调和诸药。属清热药下属分类的清热解毒药。其具有抗抑郁作用、保护心脏和舒张血管的作用,以及保护大鼠大脑免受氧化应激的影响,具体参考资料为【11】崔雨,董婉绒,刘恬恬,朱卫东,周高,陈玉欣,毛诃子化学成分及药理作用研究进展[J].中国现代中药.Jan.2023Vol.25No.1。
余甘子:味甘、酸、涩、凉,归肺、胃经。具有清热凉血,消食健胃,生津止咳功效,常用于血热血瘀,消化不良,腹胀,咳嗽,喉痛,口干。余甘子果实中含有鞣质,其中有葡萄糖没食子鞣苷,没食子酸,并没食子酸等多种化学物质。余甘果与山楂、白榄并列“世界三大杂果”。其硒含量位于人类已知食物之冠,每100克余甘果含硒0.24毫克。硒是延长寿命最重要的矿物质营养素。其具有抗动脉硬化的作用,具体参考资料为【12】范源,刘竹焕.余甘子活性成分抗动脉硬化作用的研究进展[J].云南中医学院学报.Vol.34No.2.4.2011。
知母:性味苦、甘,寒。归肺、胃、肾经。知母苦泄寒清,甘润滋滑,既入肺、胃经,又入肾与大肠经。但清降,不透散,并滋阴。上清肺热而泻火,中清胃热而除烦渴,下滋肾阴而润燥滑肠、退虚热。清热泻火虽不及石膏,但长于滋阴润燥,祛邪扶正两相兼。实火、虚热皆宜,高热或燥热津伤及阴虚发热者用之尤佳。本品含有皂苷、知母多糖、芒果苷、异芒果苷、生物碱及有机酸等成分。具有清热泻火,滋阴润燥的功效。知母活性成分知母皂甙元ZMS是一种新型的抗老年痴呆药,它能明显改善自然衰老大鼠的学习记忆能力和老年人的记忆能力。具体参考资料为【13】陈勤,胡稚儿,夏宗勤.知母皂式元对东蓑著碱所致学习记忆障碍和脑胆碱乙酞转移酶活力降低的影响[J].中药材第24卷第7期2001年7月。【14】冯菲.知母的药理作用研究进展[J].中医临床研究2017年第9卷第12期。
红景天:药性甘、苦,平。归肺、心经。红景天甘补苦泄,平而偏凉,补兼行散,入肺、心经。能益气、平喘、活血通脉,善治气虚体倦、久咳虚喘,以及气虚血瘀、血脉不畅所致诸证,兼热者尤宜。具有益气活血,通脉平喘的功效,以及一定的促智作用,改善学习记忆能力,具体参考资料为【15】孙许涛,柳颖,姜德友,陈飞,解颖,孙阳.红景天药理作用研究进展[J].中医药学报.Vol.45,No.6,Dec.2017。【16】黄钰芳.红景天活性成分及药理作用[J].中医药临床杂志.Oct.2008.Vol.20,No.5。
西洋参:味甘辛,性凉,无毒。入心、肺、肾三经。益肺阴,清虚火,生津止渴。治肺虚久嗽,失血,咽干口渴,虚热烦倦。其具有抗疲劳、增强耐缺氧的能力,同时也可改善记忆获得能力。具体参考资料为【17】王筠默.西洋参药理作用研究的最新进展[J].中药药理与临床.2001;17(4)。
甘草:药性甘、平,归心、肺、脾、胃经。甘草甘补润缓,生平偏凉,炙平偏温,主入脾、肺经,兼入胃、心经。既益气补中,又缓急止痛、缓和药性,还祛痰止咳、解毒。蜜炙补气缓急力强;生用能泻火解毒。本品含有三萜皂苷类和黄酮类等成分。甘草具有补脾益气、清热解毒、祛痰止咳、缓急止痛、调和诸药的功效,主要治疗脾胃虚弱、咳嗽痰多及中毒等,现代药理学研究证实甘草还具有抗肿瘤、抗炎、参与酶反应、抗菌、保肝、降血糖、***样作用以及抗风湿、抗精神抑郁、抑制人类免疫缺陷病毒增殖等多方面作用。具体参考资料为【18】王波,王丽,刘晓峰,曹馨元,黄文华,徐超.中药甘草成分和药理作用及其现代临床应用的研究进展[J].中国医药2022年2月第17卷第2期。
茯苓:药性甘、淡,平。归心、肺、脾、肾经。茯苓甘淡渗利兼补,性平不偏,既入脾、肾经,善渗湿利水而消水饮,健脾而促进水湿运化;又入心经,善宁心而安神,治水气凌心者为宜。凡水湿、停饮,无论寒热或兼否脾虚皆宜,脾虚水肿或湿盛者尤佳。本品主要含多糖、三萜类成分、甾醇类成分,还含蛋白质、脂肪、卵磷脂、腺嘌呤等成分。其具有镇静催眠作用,具体参考资料为【19】潘馨,董芳妮,陈艺涵,郑冬梅.茯苓中6个活性成分含量的TOPSIS综合分析法考察[J].时珍国医国药.2021年第32卷第3期。【20】叶青,刘东升,王兰霞,刘竞,张迈娜,高嘉雯,朱旭江.茯苓化学成分、药理作用及质量控制研究进展[J].2023年2月第40卷第2期。
酸枣仁:性味甘、酸,平。归肝、胆、心经。酸枣仁甘补酸敛,性平不偏,入心、肝、胆经,善养心、补肝、益胆而安神,为治阴血亏虚之心神不安、失眠多梦、惊悸之要药;兼能敛汗,治体虚多汗可选。本品含有三萜皂苷类成分、生物碱类成分、黄酮类成分,还含挥发油、糖类、蛋白质及有机酸等成分。具有养心补肝,宁心安神,敛汗,生津的功效。酸枣仁作为临床治疗失眠常用中药之一,其主要活性成分皂苷、黄酮、生物碱、油脂等都发挥着不同的药理作用。具体参考资料为【21】袁杨杨,孙从永,徐希明,余江南.酸枣仁活性成分药理作用机制的研究进展[J].中国药师.2017年第20卷第9期。
合欢皮:药性甘,平。归心、肝、肺经。合欢皮甘和缓,苦能泄,性平和,入心、肝经。既善解肝郁而安神定志,治忧郁、失眠常用;又能活血散瘀、消散痈肿,治跌打骨折、疮痈、肺痈。本品主要含木脂素类成分,还含萜类、皂苷类、鞣质。具有解郁安神,活血消肿的功效。同时还具有抗焦虑和抗抑郁的作用,具体参考资料为【22】杨磊,李棣华.合欢皮化学成分与药理活性及毒理学研究进展[J].中国中西医结合外科杂志2019年12月第25卷第6期。
百合:味甘,性寒。归心、肺经。养阴润肺,清心安神。用于阴虚燥咳,劳嗽咳血,虚烦惊悸,失眠多梦,精神恍惚。同时也具有镇静、促进睡眠和改善记忆能力的作用,具体参考资料为【23】雷蒙蒙.卷丹百合的药理作用研究进展[J].职业与健康2018年2月第34卷第3期。
柏子仁:药性甘,平。归心、肾、大肠经。柏子仁甘能补,平偏凉,质滋润,为平补润燥之品。入心、肾经,能补阴血而养心安神,善治阴血亏虚之虚烦不眠;入大肠经,能润肠燥而通便,可治阴血亏虚之肠燥便秘。此外,还能补阴血而止汗、治阴虚盗汗。本品主要含柏木醇、谷甾醇和双萜类成分;又含脂肪油,并含少量挥发油、皂苷、维生素A和蛋白质等。具有养心安神,润肠通便,止汗的功效。同时具有对阿尔茨海默病(AD)模型大鼠的行为改善作用,延长小鼠睡眠时间的作用,具体参考资料为【24】周静,许一凡.柏子仁化学成分与药理活性研究进展[J].化学研究.2019年7月第30卷第4期。【25】马欣悦,李瑞海,贾天柱.柏子仁总萜类成分药理活性及提取工艺研究[J].实用药物与临床2017年第20卷第1期。
女贞子:药性甘、苦,凉。归肝、肾经。女贞子甘补凉清,苦泄不腻,入肝、肾经,为凉补之品。善滋补肝肾之阴,并以此而清虚热、明目。女贞子含三萜类成分、环烯醚萜苷类成分、黄酮类成分、脂肪酸类成分、挥发油、多糖等成分。同时具有抗衰老、抗氧化和增强免疫调节的能力,具体参考资料为【26】毕莹,赵源,李知晓,张贺铭,孙云龙,尚坤.中药女贞子的研究进展[J].吉林中医药.2019年8月第39卷第8期。
丹参:苦能泄散,微寒能清,入心、肝经。既活血去瘀而通经止痛,又清新凉血而除烦、消痈,主治血瘀、血热、热扰心神诸证,兼治热毒疮痈肿痛。本品含有醌类成分、原儿茶醛、原儿茶酸、乳酸、维生素E等成分,具有活血祛瘀,通经止痛,清心除烦,凉血消痈的功能。同时还具有改善血流动力学效应、抗血栓和抗脂质过氧化作用,具体参考资料为【27】高波.丹参的药理分析及临床应用研究[J].中国卫生标准管理CHSM 09。【28】宋立群.丹参药理作用研究进展[J].社区医学杂志2012年12月第10卷第24期。
泡参(南沙参):味甘、微苦,性微寒。归肺、胃经。养阴清热,润肺化痰,益胃生津。用于阴虚久咳,痨嗽痰血,燥咳痰少,虚热喉痹,津伤口渴。同时还具有改善记忆的作用,具体参考资料为【29】梁莉,王婷,乔华,常威,李丹.南沙参多糖的药理作用研究进展[J].西北药学杂志.2008年10月第23卷第5期。
黄精:药性甘,平,归脾、肺、肾经。黄精质润甘补,平而不偏,作用缓和,入脾、肺、肾经,为平补气阴之品。既滋阴润肺,又补肾益精,还补脾益气,为滋补之良药,善治肺肾两虚、气阴两虚诸证。本品含有多糖、皂苷类、黄酮类等成分,具有补气养阴,健脾,润肺,益肾的功效。同时还具有抗瘤、抗氧化、抗衰老、抗疲劳、降血糖血脂、抗动脉粥样硬化、杀菌抗炎活性等药理作用,具体参考资料为【30】高嫣.多花黄精的活性成分及药理作用研究进展[J].福建农业科技,2021年.52(8)。
牡蛎:咸湿,凉。入肝、肾经。敛阴,潜阳,止汗,涩精,化痰,软坚。治惊痫,眩晕,自汗,盗汗,遗精,淋浊,崩漏,带下,瘰疬,瘿瘤。用于惊悸失眠,眩晕耳鸣,瘰疠痰核,瘕痞块,自汗盗汗,遗精崩带,胃痛泛酸。煅牡蛎收敛固涩。还具有提高机体免疫力、增强记忆力、补充精力等效果,具体参考资料为【31】冯丽,赵文静,常惟智.牡蛎的药理作用及临床应用研究进展[J].中医药信息.2011年第28卷第1期。
龙眼肉:甘、平。入心、脾经。补心脾;益气血;安心神。主心脾两虚;气血不足所致的惊悸;怔忡;失眠;健忘;血虚萎黄;有经不调;崩漏。龙眼肉营养丰富,主要化学成分为糖类、脂类、皂苷类、多肽类、多酚类、挥发性成分、氨基酸及微量元素。同时还具有抗应激、抗焦虑和抗氧化作用,具体参考资料为【32】盛康美,王宏洁.龙眼肉的化学成分与药理作用研究进展[J].中国实验方剂学杂志.2010年5月第16卷第5期。
益智仁:药性辛,温;归脾、肾经。本品辛温香燥,温补固涩,入脾、肾经。既暖肾固精缩尿,治肾虚遗精滑泄;又温脾止泻、开胃摄唾,治脾寒泄泻腹痛或多涎唾。本品主要含挥发油:桉油精、姜烯、姜醇等;还含庚烷衍生物类成分、微量元素、维生素、氨基酸、脂肪酸等成分。益智仁活性成分具有明确的神经保护作用,具体参考资料为【33】王双,王婷婷,张蕻,施怀生,赵思俊,朴晋华,田俊娜[J].基于网络药理学探讨益智仁对阿尔茨海默病的作用机制.中国中医药现代远程教育.2021年1月第19卷第1期。
山药:山药性平味甘,温补而不骤,微香而不燥,归脾、肺、肾经,是补脾养胃、生津益肺的良药,也是传统的保健食品。山药中含有丰富的微量元素。其具有一定的抗氧化和改善老年痴呆症的作用,具体参考资料为【34】刘改枝,朱奕林,许杜娟,刘萌芽,蔡邦荣.山药活性成分抗老年痴呆症的网络药理学作用机制探讨[J].中药新药与临床药理2021年3月第32卷第3期。【35】杨雁,孙羽灵,孙建梅,唐宗湘.山药活性成分药理作用研究进展[J].中国野生植物资源.2022年12月第41卷第12期。
灵芝:药性平味甘,归心、肝、肺、肾经,灵芝能补气安神,止咳平喘,用于心神不宁,失眠心悸,肺虚咳喘,虚劳短气,不思饮食等症状。灵芝含有多种化学成分,其中的活性成分以多糖、三萜、核苷、甾醇类为主。灵芝对心血管***具有广泛的调节作用,灵芝中含有的腺苷能有效降低血液黏稠度,抑制体内血小板聚集,提高血红蛋白的含量,提高血液供氧能力,加速血液循环。灵芝对血压具有双向调节作用;能有效舒张冠状动脉,增加血流量,改善身体微循环,还能增加心肌供氧量,降低血液中的胆固醇和中性脂肪含量。具体参考资料为【36】谢怡琼,王琪瑞,孙思雅,来梦茹,程汝滨,***.灵芝的药理作用和临床应用研究进展[J].临床医学研究与实践.2020,5(10)。【37】宋保兰[J].灵芝的药理作用研究进展[J].中国民族民间医药.2014,23(10)。
当归:当归性温、辛、甘,具有润燥滑肠、治疗便秘及***等多种功效,因此,常被中医们称为“药王”。同时还具有增加血流量、补血、保护神经***的作用,具有良好的抗惊厥、镇痛和神经修复等作用,具体参考资料为【37】黄红泓,覃日宏,柳贤福.中药当归的化学成分分析与药理作用探究[J].世界最新医学信息文摘2019年第19卷第58期。
龟甲胶:性凉,味咸,入肝、肾、心经,主要有滋阴养血、强筋健骨等作用,适用于阴虚潮热,骨蒸盗汗,腰膝酸软,血虚萎黄等症状,尤其适合需要强筋健骨、滋阴养血以及更年期女性人群。同时具有增强免疫功能,增加冠脉流量和提高耐缺氧能力,具体参考资料为【38】郑本端,吕国桥,罗自文.龟甲胶药理作用研究进展[J].时珍国医国药.2001年第12卷第5期。
本具有益智效果的中药组方依据中医药膏方配方思想:以读书丸(远志、石菖蒲、菟丝子、生地黄、地骨皮、五味子、酸枣仁、当归、川芎)为君方,主治健忘,增强记忆力;臣以三勒浆方(藏青果、毛诃子、余甘子、红景天、西洋参),抗疲劳、耐缺氧、免疫力调节,以助增强记忆之功,提高大脑供血供氧,提升学习专注度,改善学习注意力不能集中的现象;臣以孔圣枕中汤(龟甲胶、龙骨、远志、石菖蒲、灵芝)具有补益心肾,益智安神的功效,用于心肾不交所致的失眠、健忘,神疲体倦,以增强君方主治健忘之效;佐以酸枣汤(酸枣仁、川芎、知母、茯苓、甘草、龙眼肉、牡蛎)一则增强君方治健忘之功;二则有养血镇静安神、清热除烦的功效,适用于肝血不足、压力过大而引起的失眠。再佐以益智仁温脾,暖肾,益智;佐以百合、柏子仁、泡参清心安神,以助记忆;佐以山药,黄精、女贞子补肾滋阴健脑;佐以合欢皮,丹参活血通脉,解郁安神,使全方补中有清,补而不滞。
综观全方:益智健脑,养血安神,主治心肾亏虚所致的记忆减退、健忘、易疲劳,注意力不集中、反映迟钝、失眠等证,帮助学习,提高学习效率。本方兼顾五脏,补中有清,补而不滞,并顾全药味的温热寒凉。
实施例1中药液的制备
1、准确称量以下中药原料药和化学原料:远志175份、生地95份、菟丝子95份、五味子145份、石菖蒲145份、龙骨95份、川芎145份、地骨皮95份、藏青果75份、毛诃子75份、余甘子75份、知母145份、红景天115份、西洋参145份、甘草45份、茯苓95份、酸枣仁145份、当归145份、灵芝85份、合欢皮95份、百合115份、山药145份、柏子仁45份、女贞子45份、丹参145份、泡参115份、黄精145份、牡蛎145份、龙眼肉95份、龟甲胶95份和益智仁145份,小苏打粉2份,纽糖1份,山梨酸钾1份。
其中纽糖为一种复合甜味剂,分子式为C20H30N2O5,CAS号165450-17-9,由广东康之源食品配料有限公司生产,纯度99%,型号为食品级。
山梨酸钾,分子式为C6H7KO2,CAS号590-00-1,上海申夏生物化工有限公司生产,纯度99%,25kg(净重)纸箱包装。
小苏打,分子式为NaHCO,CAS号144-55-8,苏州品顺化工有限公司生产,纯度99%,25kg袋装。
2、制备方法:
(1)将龟甲胶用粉碎机打成粉末备用,将藏青果、毛诃子和益智仁分别用钵捣破备用;
(2)按照全部所述原料药重量之和的3倍计算加水总量,分两次进行煎药;
(3)浸泡:将以下原料药:远志、生地、菟丝子、五味子、石菖蒲、龙骨、川芎、地骨皮、藏青果、毛诃子、余甘子、知母、红景天、西洋参、甘草、茯苓、酸枣仁、当归、灵芝、合欢皮、百合、山药、柏子仁、女贞子、丹参、泡参、黄精、牡蛎和龙眼肉放入加水总量的60%的清水中浸泡2小时;
(4)煎煮:先用武火烧开后,改用中火煎煮0.5小时,再加入益智仁煎煮0.5小时,倒出药汁;剩余药渣加入剩余水量进行第二次煎药,同样先用武火烧开后改用中火煎煮45分钟,倒出药汁;
(5)静置、过滤:将两次药汁合并混合均匀,将合并的药汁静置3小时,用200目的滤网过滤药汁;过滤药汁再静置2小时,再次过滤药汁;
(6)浓缩:将过滤好的药汁先用武火烧开后,改用中火继续浓缩至过滤好的药汁体积的40~42%,加入龟甲胶后改用文火浓缩至过滤好的药汁体积的36~38%。
(7)添加矫味剂及防腐剂:先加入小苏打粉,待药汁内泡沫散尽时,加入纽糖和山梨酸钾,继续浓缩。
(8)灌装:待药汁浓缩至过滤好的药汁体积的34~35%时得到浓缩液,停止加热,待药汁温度下降至60℃时,将浓缩液置于膏体灌装机内,灌装至已消毒的口服液瓶中。
实施例2中药液的制备
1、准确称量以下中药原料药和化学原料:远志180份、生地100份、菟丝子100份、五味子150份、石菖蒲150份、龙骨100份、川芎150份、地骨皮100份、藏青果80份、毛诃子80份、余甘子80份、知母150份、红景天120份、西洋参150份、甘草50份、茯苓100份、酸枣仁150份、当归150份、灵芝90份、合欢皮100份、百合120份、山药150份、柏子仁50份、女贞子50份、丹参150份、泡参120份、黄精150份、牡蛎150份、龙眼肉100份、龟甲胶100份和益智仁150份,小苏打粉5份,纽糖3份,山梨酸钾5份。
2、制备方法:
(1)将龟甲胶用粉碎机打成粉末备用,将藏青果、毛诃子和益智仁分别用钵捣破备用;
(2)按照全部所述原料药重量之和的4倍计算加水总量,分两次进行煎药;
(3)浸泡:将以下原料药:远志、生地、菟丝子、五味子、石菖蒲、龙骨、川芎、地骨皮、藏青果、毛诃子、余甘子、知母、红景天、西洋参、甘草、茯苓、酸枣仁、当归、灵芝、合欢皮、百合、山药、柏子仁、女贞子、丹参、泡参、黄精、牡蛎和龙眼肉放入加水总量的60%的清水中浸泡2小时;
(4)煎煮:先用武火烧开后,改用中火煎煮0.5小时,再加入益智仁煎煮0.5小时,倒出药汁;剩余药渣加入剩余水量进行第二次煎药,同样先用武火烧开后改用中火煎煮45分钟,倒出药汁;
(5)静置、过滤:将两次药汁合并混合均匀,将合并的药汁静置3小时,用200目的滤网过滤药汁;过滤药汁再静置2小时,再次过滤药汁;
(6)浓缩:将过滤好的药汁先用武火烧开后,改用中火继续浓缩至过滤好的药汁体积40~42%,加入龟甲胶后改用文火浓缩至过滤好的药汁体积的36~38%。
(7)添加矫味剂及防腐剂:先加入小苏打粉,待药汁内泡沫散尽时,加入纽糖和山梨酸钾,继续浓缩。
(8)灌装:待药汁浓缩至过滤好的药汁体积的34~35%时得到浓缩液,停止加热,待药汁温度下降至60℃时,将浓缩液置于膏体灌装机内,灌装至已消毒的口服液瓶中。
实施例3中药液的制备
1、准确称量以下中药原料药和化学原料:远志185份、生地105份、菟丝子105份、五味子155份、石菖蒲155份、龙骨105份、川芎155份、地骨皮105份、藏青果85份、毛诃子85份、余甘子85份、知母155份、红景天125份、西洋参155份、甘草55份、茯苓105份、酸枣仁155份、当归155份、灵芝95份、合欢皮105份、百合125份、山药155份、柏子仁55份、女贞子55份、丹参155份、泡参125份、黄精155份、牡蛎155份、龙眼肉105份、龟甲胶105份和益智仁155份,小苏打粉10份,纽糖6份,山梨酸钾10份。
2、制备方法:
(1)将龟甲胶用粉碎机打成粉末备用,将藏青果、毛诃子和益智仁分别用钵捣破备用;
(2)按照全部所述原料药重量之和的5倍计算加水总量,分两次进行煎药;
(3)浸泡:将以下原料药:远志、生地、菟丝子、五味子、石菖蒲、龙骨、川芎、地骨皮、藏青果、毛诃子、余甘子、知母、红景天、西洋参、甘草、茯苓、酸枣仁、当归、灵芝、合欢皮、百合、山药、柏子仁、女贞子、丹参、泡参、黄精、牡蛎和龙眼肉放入加水总量的60%的清水中浸泡2小时;
(4)煎煮:先用武火烧开后,改用中火煎煮0.5小时,再加入益智仁煎煮0.5小时,倒出药汁;剩余药渣加入剩余水量进行第二次煎药,同样先用武火烧开后改用中火煎煮45分钟,倒出药汁;
(5)静置、过滤:将两次药汁合并混合均匀,将合并的药汁静置3小时,用200目的滤网过滤药汁;过滤药汁再静置2小时,再次过滤药汁;
(6)浓缩:将过滤好的药汁先用武火烧开后,改用中火继续浓缩至过滤好的药汁体积40~42%,加入龟甲胶后改用文火浓缩至过滤好的药汁体积的36~38%。
(7)添加矫味剂及防腐剂:先加入小苏打粉,待药汁内泡沫散尽时,加入纽糖和山梨酸钾。
(8)灌装:待药汁浓缩至过滤好的药汁体积的34~35%时得到浓缩液,停止加热,待药汁温度下降至60℃时,将浓缩液置于膏体灌装机内,灌装至已消毒的口服液瓶中。
对本具有益智效果的中药液做药理学毒性实验、对小鼠学习记忆的影响试验、对小鼠抗疲劳效果试验、改善睡眠人体试食试验和儿童试用临床试验,试验条件及结果如下:
一、以实施例2的中药液为实验物,经药理学毒性实验进行验证药理学毒性实验包含急性毒性实验和长期毒性实验。急性毒性实验如下:
1、实验方法
将豚鼠背部脊柱两侧将脱毛剂均匀涂上,使去毛范围约20平方厘米。洗净脱毛剂归笼观察24小时,每组豚鼠分别涂本发明中药液4、8和12g,分别含生药90mg、182mg和366mg,另一组涂溶媒0.8ml每日二次,连续一周,实验结束后,将豚鼠处死,心,肝,肾及脱毛皮肤做病理检验。
2、结果
上述三组用药豚鼠躯干脱毛区,未见局部皮肤有水肿、充血、红斑、出血点及溃疡。用药组豚鼠毛发色泽、摄食、四肢活动等对照组无明显差异,病理组织学检查,给药组心、肝、肾及脱毛皮与对照字比较也无明显差异。
结果提示,本发明无局部刺激作用,也未见全身毒性表现。表明本发明制剂使用安全。
长期毒性实验如下:
1、实验方法
将豚鼠随机份成4组,每组15只,在豚鼠背部脊柱两侧将脱毛剂均匀涂上,使其脱毛范围约20平方厘米。洗净脱毛剂,观察24小时后每组豚鼠分别涂本发明中药液0.2、0.4和0.8ml,分别含生药90、182和366mg,另一组涂溶媒0.8ml每日二次,连续30天,观察豚鼠的一般情况,实验结束后处死动物进行血液学、血液生化及病理学检查。
2、结果
上述三组用药豚鼠躯干去毛区,未见局部皮肤有水肿、充血、红斑、出血点及溃疡。用药组与对照组动物毛发色泽、摄食、四肢活动等对照组无明显差异,血液生化检查,用药组与对照组均在正常范围。病理组织学检查,实验各组心、肝、肾及局部皮肤均未见明显病变。提示,本发明长期用药对局部皮肤及全身重要脏器均未见明显的毒性作用。试验结果表明:本发明实验安全。
累计毒性实验:
本发明口服液剂对小鼠按7.83、19.02和42.98g生药/kg连续用药15周(1.0ml/100g体重,每天2次)及停药3周后,结果表明:本发明对大鼠的毛发、行为、大小便、体重、脏器重量、血象、肝肾功能、血糖、血脂等指标均无明显影响,脏器肉眼没有发现异样变化和组织学检查结果表明,用药15周及停药3周后,大鼠各脏器均无明显改变。说明本发明对大鼠长期用药后毒性小,停药后也没有异样反应,应用安全。
二、本发明中药液对小鼠学习记忆的影响试验
用跳台法预选合格的SPF级BABL/c小鼠100只,2月龄,体重20~24g,雌雄各半,将小鼠随机分为4组,每组25只,分别为实施例1组、实施例2组、实施例3组和空白对照组。其中,空白对照组灌胃给蒸馏水,实施例1、2和3组分别灌胃实施例1、2和3的中药液,每次灌胃剂量为600mg/kg,每日灌胃2次。各组大鼠连续灌胃21天。第20天以跳台法分别训练每只小鼠1次,24h后开始测试并记录每组小鼠的跳下潜伏期(自跳台上跳下的时间)和5min内错误次数。结果见下表1。
表1本发明中药液对正常小鼠学习和记忆获得能力的影响
组别 | 跳下潜伏期(s) | 5min内错误次数 |
实施例1组 | 16.65±3.64 | 2.67±1.06 |
实施例2组 | 18.97±3.01 | 2.36±1.03 |
实施例3组 | 18.03±2.33 | 2.86±1.05 |
空白对照组 | 10.87±2.88 | 5.42±1.26 |
结果显示,本发明实施例1-3制得的中药液可显著增强小鼠的学习记忆能力,尤其以实施例2的效果最佳。
三、本发明中药液对小鼠抗疲劳效果试验
用游泳法预选合格健康SPF级BABL/c小鼠,75只,2月龄,体质量20~24g,自由饮水、饮食,动物观察适应5天后,进行实验。动物随机分为正常对照组、游泳对照组、实施例1组、实施例2组和实施例3组共五组,每组15只动物,实施例1、2和3组分别灌胃实施例1、2和3的中药液,每次灌胃剂量为1200mg/kg,每日灌胃1次,持续2周,正常对照组和游泳对照组动物灌胃等量的蒸馏水。
小鼠游泳实验及观察指标
正式游泳前,动物游泳训练5次。(1)力竭性游泳:实施例1、2、3组和游泳对照组均于1次灌胃30分钟后,同时置于游泳装置中开始3%的负重游泳,水温30℃,游泳直至力竭(沉入水中30秒不起)。记录力竭性游泳时间。(2)90min游泳:实施例1组、实施例2组、实施例3组和游泳对照组动物均于末次灌胃后30分钟,同时置于游泳装置中,水温30℃,游泳时间为90min。正常对照组不游泳。游泳结束后,立即摘取小鼠眼球采血,离心取血清,测定血糖含量以及乳酸含量、血尿素氮含量以及肝糖原含量。
表2各组小鼠力竭性游泳时间比较(min)
组别 | 数量(n) | 力竭性游泳时间(min) |
游泳对照组 | 15 | 0.86±0.15 |
实施例1组 | 15 | 1.47±0.12 |
实施例2组 | 15 | 1.53±0.13 |
实施例3组 | 15 | 1.52±0.15 |
由表2可见,与游泳对照组相比,实施例1、2和3组分别对力竭性游泳时间有所延长,差异有显著性。
表3各组小鼠游泳结束后血糖、血乳酸、血尿素氮及肝糖原检测结果比较
由表3看出,与正常对照组比较,游泳对照组血糖、肝糖原含量均降低,血乳酸、尿素氮水平升高,差异均有显著性。与游泳对照组比较,实施例1、2和3组的血糖和肝糖原水平均有所回升,血乳酸与尿素氮水平有所下降,其中,血糖和尿素氮变化有一定的计量效应趋势,实施例1、2和3组血糖含量显著高于游泳对照组,实施例1、2和3组血尿素氮水平显著低于游泳对照组,实施例1、2和3组肝糖原水平均高于游泳对照组,差异有显著性。
本实验结果显示,使用本发明中药液后,动物力竭性游泳时间显著延长,表明本发明中药组合物具有显著的提神抗疲劳作用。同时,动物的血糖、肝糖原水平回升,体内蛋白质分解也减少,表现为血尿素氮水平上升幅度减小,说明本发明中药液具有提高游泳动物血糖与肌糖元水平、减少体内蛋白质分解的作用,从而有效的延缓疲劳的发生。
四、本发明中药液改善睡眠人体试食试验
采用自身和组间两种对照设计,选择60例单纯的长期患有失眠症的患者,年龄18~60岁,依据症状轻重随机分为试食组和对照组,每组30例,试食组男性13例,女性17例,平均年龄为52.75±10.25岁,对照组男性15例,女性15平均年龄为51.26±9.79。试食组:服用本发明实施例2制备得到的中药液,对照组食用安慰剂,安慰剂外观、色泽、重量、服用方法与本发明相同。受试者每人每日服3次,每次30ml。试验期间正常饮食,不改变原来的饮食习惯,并停用其他治疗失眠的药品及中药组合物,观察期间为90天。
症状积分观察:按失眠症状的轻重情况累计积分(重症3分、中度2分、轻度1分)。两组症状积分在治疗前无显著性差异(P>0.05)。试食前两组血、尿、便常规及肝肾功能、胸透、心电图、B超等检查均在正常范围。
试食组试食前后自身比较及对照组组间比较,临床症状积分明显减小(P<0.01),试食组人群睡眠情况明显改善,且未报告其它副作用,本发明中药组合物有改善睡眠的功能。结果见表4。
表4试食前后临床症状积分
**与试食前比较,P<0.01;##组间比较,P<0.01。
五、本发明中药液儿童试用临床试验
本发明方案的实施例2经32位青少年试用,年龄12~19岁,结果如下:
1、基本情况:共计32位青少年,大多基本符合“中医虚证辨证参考标准”(1986年5月修订)中所述心脾虚证范围,但症状均较轻。随机将所有用药者分为两组,口服液组(实施例2)16例,对照(糖水)组16例。
2、治疗方法:口服液组、对照组均每天口服两次,每次30ml,疗程均为30天。
3、疗效判定标准:心脾两虚大多具有精神不振、全身乏力、反应迟钝、多梦、健忘、食少等虚损症状,根据青少年试用后相关症状减轻程度制定疗效判定标准。
①显效:症状、体征明显改善。
②有效:症状、体征均有好转。
③无效:症状、体征无明显改善或加重者。
4、统计学方法采用t检验和ⅹ2检验。
5、结果
两组用药者临床疗效比较,口服液组16例中显著效果14例,有效果2例,无效0例,总有效率为100%;对照组16例中显效0例,有效1例,无效15例,总有效率6.25%。由以上数据表明口服液组总有效率大于对照组,经t检验,两组差异具统计学意义(P<0.001)。
本具有益智效果的中药组分及中药液是专门、多途径会对提高学习效率的一种中药口服液,且具有以下优势:
1.通过改善健忘症状,增强学习记忆能力;
2.通过增强大脑供血,供氧,改善脑部微循环,抗疲劳,增强学习的专注度,提高应激,反应能力;
3.针对失眠,改善睡眠质量,提高学习效率;
4.益智健脑,提供大脑发育的物质及微量元素,更有利于学习;
5.口感好,学生乐于接受。
本发明提供了以上详细描述了本发明的较佳具体实施例。应当理解,本领域的普通技术人员无需创造性劳动就可以根据本发明的构思做出诸多修改和变化。因此,凡本技术领域中技术人员依本发明的构思在现有技术的基础上通过逻辑分析、推理或者有限的实验可以得到的技术方案,皆应在由权利要求书所确定的保护范围内。
Claims (10)
1.一种具有益智效果的中药组方,其特征是:由以下重量份的原料药制成:远志175~185份、生地95~105份、菟丝子95~105份、五味子145~155份、石菖蒲145~155份、龙骨95~105份、川芎145~155份、地骨皮95~105份、藏青果75~85份、毛诃子75~85份、余甘子75~85份、知母145~155份、红景天115~125份、西洋参145~155份、甘草45~55份、茯苓95~105份、酸枣仁145~155份、当归145~155份、灵芝85~95份、合欢皮95~105份、百合115~125份、山药145~155份、柏子仁45~55份、女贞子45~55份、丹参145~155份、泡参115~125份、黄精145~155份、牡蛎145~155份、龙眼肉95~105份、龟甲胶95~105份和益智仁145~155份。
2.如权利要求1所述的具有益智效果的中药组方,其特征是:由以下重量份的原料药制成:远志175~180份、生地95~100份、菟丝子95~100份、五味子145~150份、石菖蒲145~150份、龙骨95~100份、川芎145~150份、地骨皮95~100份、藏青果75~80份、毛诃子75~80份、余甘子75~80份、知母145~150份、红景天115~120份、西洋参145~150份、甘草45~50份、茯苓95~100份、酸枣仁145~150份、当归145~150份、灵芝85~90份、合欢皮95~100份、百合115~120份、山药145~150份、柏子仁45~50份、女贞子45~50份、丹参145~150份、泡参115~120份、黄精145~150份、牡蛎145~150份、龙眼肉95~100份、龟甲胶95~100份和益智仁145~150份。
3.如权利要求1所述的具有益智效果的中药组方,其特征是:由以下重量份的原料药制成:远志180~185份、生地100~105份、菟丝子100~105份、五味子150~155份、石菖蒲150~155份、龙骨100~105份、川芎150~155份、地骨皮100~105份、藏青果80~85份、毛诃子80~85份、余甘子80~85份、知母150~155份、红景天120~125份、西洋参150~155份、甘草50~55份、茯苓100~105份、酸枣仁150~155份、当归150~155份、灵芝90~95份、合欢皮100~105份、百合120~125份、山药150~155份、柏子仁50~55份、女贞子50~55份、丹参150~155份、泡参120~125份、黄精150~155份、牡蛎150~155份、龙眼肉100~105份、龟甲胶100~105份和益智仁150~155份。
4.如权利要求1所述的具有益智效果的中药组方,其特征是:由以下重量份的原料药制成:远志180份、生地100份、菟丝子100份、五味子150份、石菖蒲150份、龙骨100份、川芎150份、地骨皮100份、藏青果80份、毛诃子80份、余甘子80份、知母150份、红景天120份、西洋参150份、甘草50份、茯苓100份、酸枣仁150份、当归150、灵芝90、合欢皮100份、百合120份、山药150份、柏子仁50份、女贞子50份、丹参150份、泡参120份、黄精150份、牡蛎150份、龙眼肉100份、龟甲胶100份和益智仁150份。
5.一种具有益智效果的中药液,其特征在于:所述中药液是由如权利要求1至4任一所述的中药组方通过水煎煮的方法获得,按照全部所述原料药重量之和的3至5倍计算加水总量,分两次进行煎药。
6.如权利要求5所述的具有益智效果的中药液,其特征在于:所述中药液的制备方法如下所示:
(1)浸泡:将以下原料药:远志、生地、菟丝子、五味子、石菖蒲、龙骨、川芎、地骨皮、藏青果、毛诃子、余甘子、知母、红景天、西洋参、甘草、茯苓、酸枣仁、当归、灵芝、合欢皮、百合、山药、柏子仁、女贞子、丹参、泡参、黄精、牡蛎和龙眼肉放入加水总量的60%的清水中浸泡2小时;
(2)煎煮:先用武火烧开后,改用中火煎煮0.5小时,再加入益智仁煎煮0.5小时,倒出药汁;剩余药渣加入剩余水量进行第二次煎药,同样先用武火烧开后改用中火煎煮45分钟,倒出药汁;
(3)静置、过滤:将两次药汁合并混合均匀,将合并的药汁静置3小时,用200目的滤网过滤药汁;过滤药汁再静置2小时,再次用200目的滤网过滤药汁;
(4)浓缩:将过滤好的药汁先用武火烧开后,改用中火继续浓缩至过滤好的药汁体积的40~42%,加入龟甲胶后改用文火浓缩至过滤好的药汁体积的36~38%。
7.如权利要求6所述的具有益智效果的中药液,其特征在于:在步骤(4)之后还包括步骤(5)添加矫味剂,所述矫味剂为甜味剂、芳香剂、胶浆剂和泡腾剂中的一种或多种的组合;所述矫味剂为泡腾剂和甜味剂的组合,所述泡腾剂为小苏打粉,所述甜味剂为纽糖,先加入小苏打粉,待药汁内泡沫散尽时,加入纽糖;按重量份算,所述小苏打粉2~10份,所述纽糖1~6份。
8.如权利要求7所述的具有益智效果的中药液,其特征在于:在步骤(5)之后还包括步骤(6)添加防腐剂,所述防腐剂为山梨酸钾,按重量份算,所述山梨酸钾1~10份。
9.如权利要求8所述的具有益智效果的中药液,其特征在于:在步骤(6)之后还包括步骤(7)灌装,待药汁浓缩至过滤好的药汁体积的34~35%时得到浓缩液,停止加热,待药汁温度下降至60℃时,将浓缩液置于膏体灌装机内,灌装至已消毒的口服液瓶中。
10.一种具有益智效果的药物制剂,其特征是:所述药物制剂是将如权利要求5至9任一项所述的中药液加入药剂学上常用的辅料制备而成;所述药物制剂的剂型属于内服药物剂型;所述内服药物剂型包括糖衣片剂、薄膜衣片剂、肠溶衣片剂、胶囊剂、口服液、糖浆剂、***剂、颗粒剂、滴丸剂、散剂、膏剂、混悬剂、粉剂。
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