CN111821375A - 一种中药组合物在制备治疗痴呆药物中的应用 - Google Patents
一种中药组合物在制备治疗痴呆药物中的应用 Download PDFInfo
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Abstract
本发明公开了一种中药组合物在制备治疗痴呆的药物中的应用,该中药组合物由黄芪、人参、丹参等11味中药组成,本研究发现在西药常规治疗的基础上加入本发明药物治疗老年痴呆的疗效和改善患者的生活质量方面,明显优于单纯西药治疗,充分证实本发明药物对各种原因引起的痴呆具有显著的临床疗效。
Description
技术领域
本发明涉及一种中药组合物的新用途,具体地说,本发明涉及一种中药组合物在制备治疗痴呆的药物中的应用。
背景技术
痴呆是指慢性获得性进行性智能障碍综合征。临床上以缓慢出现的智能减退为主要特征,伴有不同程度的人格改变。它是一组临床综合征,而非一种独立的疾病。老年性痴呆被定义为发生在老年期的痴呆,故又称为老年人痴呆或老年期痴呆,包括老年性痴呆、血管性痴呆和两者并存的混合性痴呆。但是,目前的流行病学资料显示,随着脑卒中发病的年轻化,血管性痴呆也可以发生于40~60岁的中年人群;而老年性痴呆的发病人群也同样呈现年轻化的趋势,已不再是老年人的专利。
血管性痴呆(VD),是指与脑血管病有关的痴呆,它常常发生在脑卒中后的3个月内,但是这段时间内,经治医生与患者家属的注意力多集中在肢体活动的康复上,因而很容易忽视痴呆症状的出现,造成漏诊。VD主要是因为脑动脉硬化造成狭窄或闭塞引起脑血流量减少所致。脑梗死、脑出血、多发性腔梗都可以造成继发性VD,其严重程度不仅取决于病灶的大小、数目,也取决于病灶的部位,病灶位于双侧丘脑、基底节区等处引起认知、记忆功能障碍的程度会较为严重,而高龄、吸烟、痴呆家族史、复发性卒中史和低血压者等易患血管性痴呆。
老年性痴呆(阿尔茨海默病,AD),病因目前尚不完全清楚,已证实与老龄化和遗传基因以及脑内乙酰胆碱神经元减少等相关。绝大部分的流行病学研究都显示,家族史是AD的危险因素。目前已知至少有4个与AD有关的遗传病理基因,位于2l、14、1号染色体的病理基因与早发型痴呆相关,位于19号染色体的病理基因与迟发型痴呆相关。通过病理检查,可以发现患者脑内存在老年斑和神经纤维缠结。AD是一种老年性脑功能减退性疾病,尽管可以通过药物与生活方式干预使症状得到轻度的改善,发展进程得到稍微缓解,但是从总体上仍是无法逆转的;而VD如果能够尽早发现,可以通过药物以及大脑康复训练而逆转。
混合性痴呆(MD)也是相当常见的痴呆类型,在痴呆发病总数中,约占10%-20%,而且两种混合的痴呆类型可以互相促进。脑血管疾病可以加重阿尔茨海默痴呆,因此脑血管意外不但是血管性痴呆的直接原因,而且是阿尔茨海默痴呆的危险因素。脑出血或脑梗死发生后,脑血流量降低,使脑的氧化代谢和糖代谢下降,不仅导致神经元损伤和死亡,也会使淀粉样蛋白在脑内沉积,形成老年斑,促使老年性痴呆发生。老年痴呆(AD)及血管性痴呆(VD)是老年期痴呆最常见类型,过去人们认为两者的病因及发病机制无相关性。但随着对痴呆相关研究的不断深入,人们认识到随年龄增长,AD与 VD的临床及病理学表现常同时存在,临床将这类病人诊断为混合性痴呆(mixeddementia,MD),这个概念最早为Delay于1962提出,迄今已成为常见的痴呆类型之一。混合性痴呆的病人同时具备老年痴呆和血管性痴呆两种痴呆的特点,例如起病十分隐匿,认知功能缓慢地、渐进性地减退,但病人同时又有高血压、高脂血症、糖尿病等多种疾病,在某一段时间里又多次发生脑血管意外,使智力衰退在缓慢进展的基础上,又出现阶梯式的下降,并出现神经系统的局灶性症状和体征,同时逐步丧失自知力。脑CT或磁共振检查,除了发现大脑弥漫性萎缩以外,还有多发性的梗死病灶。据欧美各国统计,脑变性疾病引起的痴呆—老年性痴呆占50%以上,脑血管病引起的血管性痴呆占15%—20%。据日本的统计资料,老年性痴呆占33.7%,血管性痴呆占36.3%,混合性痴呆占19.5%,其他原因引起的痴呆占10.5%。我国27个城市普查资料表明,60岁以上老人中血管性痴呆的患病率为324/10万人口,老年性痴呆为238/10万人口;血管性痴呆的患病率城市高于农村,老年性痴呆正相反,农村多于城市。
痴呆的临床表现主要为,记忆减退是主要的核心症状。早期出现近记忆障碍,学习新事物的能力明显减退,严重者甚至找不到回家的路。随着病情的进一步发展,远记忆也受损。思维缓慢、贫乏,对一般事物的理解力和判断力越来越差,注意力日渐受损,可出现时间、地点和人物定向障碍,有时出现不能写字,不能识别人物。痴呆的另一个早期症状是学习新知识、掌握新技能的能力下降。其抽象思维、概括、综合分析和判断能力进行性减退。记忆和判断的受损可出现定障碍,患者丧失时间、地点、人物甚至自身的辨认能力。故常昼夜不分,不识归途或无目的漫游。情绪方面,患者早期可出现情绪不稳,在疾病演进中逐渐变性淡漠及迟钝。有时情感失去控制能力,变得浮浅而多变。表现焦虑不安,抑郁消极,或无动于衷,或勃然大怒,易哭易笑,不能自制。部分患者可首先出现人格改变。通常表现兴趣减少、主动性差、社会性退缩,但亦可表现为脱抑制行为,如冲动、幼稚行为等。患者的社会功能受损,对自己熟悉的工作不能完成。晚期生活不能自理,运动功能逐渐丧失,甚至穿衣、洗澡、进食以及大小便均需他人协助。甚至出现躁狂,幻觉等。
目前AD的治疗目标只是延缓痴呆 的进程,减轻痴呆的症状,提高患者的生活质量,从而延长患者的寿命。药物方面,目前胆碱酯酶抑制剂可以改善老年人的学习和记忆能力,其中使用得最广泛与最有效的代表药物是加兰他敏,多奈哌齐副作用较小,两者均可用于治疗轻度和中度AD,美金刚则用于中重度AD的治疗。另一种治疗药物是脑代谢赋活药物,作用较多而复杂,主要是扩张脑血管,增加脑皮质细胞对氧、葡萄糖、氨基酸和磷脂的利用,促进脑细胞的恢复,改善脑细胞功能,从而达到提高记忆力的目的。
中医关于痴呆的描述见于“痴证”“呆病”“善忘”“郁证”“癫证”等病证中,现代中医将其纳入“呆病”范畴。此病病位在脑,病本在肾。《灵枢·海论》中日:“脑为髓之海……髓海不足,则脑转耳鸣,胫酸眩冒,目无所见,懈怠安卧。”《素问·五脏生成》日:“诸髓者,皆属于脑。”中医学认为肾藏精主骨生髓,《灵枢·海论》日:“肾主骨,生髓通于脑。”唐容川《内经精义》日:“事物所以不忘,赖此记性,记在何处,则在肾经,益肾生精化为髓,而藏于脑。”肾虚为痴呆致病之本,《医学心悟》日:“肾主智,肾虚则智不足。”近现代医学家对痴呆病因病机的认识大体趋于一致:该病病位在脑,病变基础在肾,涉及心、肝、脾等脏腑,在肾精亏虚的前提下产生瘀血、痰浊后形成的本虚标实、虚实夹杂证。故对痴呆的治疗以补肾填精为主,辅以养心益气、祛瘀化痰等法。痴呆在中医上分为以下症状:1、心肝火旺症:眩晕头痛,心烦易怒,夜寐不安,咽干口燥,尿赤便干,舌红苔黄,脉弦数。2、痰浊阻窍症:头重如裹,腹胀痞满,呆钝少言,倦怠殖嗜卧,脉弦滑。3、气滞血瘀证:神情呆滞,智力减退,语言颠倒,善忘,口干不欲饮,肢体麻木不遂,舌质暗紫,或有瘀点瘀斑,舌苔薄白,脉细弦或脉涩。4、髓海不足证:头晕耳鸣,怠惰思卧,毛发焦枯,骨软痿弱,舌淡苔白,脉沉细弱,两尺无力。5、肝肾亏虚症:鸛红盗汗,眩晕耳鸣,肌肤不荣,筋惕肉润,舌红少苔,脉弦细数。6、脾肾两虚证:倦怠流涎、四肢欠温,纳呆乏力,腹胀便溏,舌淡体胖,苔白滑,脉沉无力。中药调节机体的免疫功能,使人体恢复到正常平衡状态,改善患者的生活质量,从而达到治疗痴呆的目的,且中药治疗疾病具有副作用小的特点,目前市场上治疗老年痴呆的中成药较多,但是效果一般,因此研制出对痴呆有效的中成药,将具有广阔的市场前景。
发明内容
本发明目的是提供一种中药组合物在制备治疗痴呆药物中的应用。
本发明所述中药组合物由如下重量份的原料药制成:
黄芪 150-450份、附子40-120份、人参或党参75-225份、丹参75-225份、葶苈子50-150份、香加皮或南五加皮60-180份、泽泻75-225份、玉竹25-75份、桂枝30-90份、红花30-90份、陈皮25-75份。
优选地,该中药组合物由如下重量份的原料药制成:
黄芪450份、附子40份、人参或党参225份、丹参75份、葶苈子150份、香加皮或南五加皮60份、泽泻225份、玉竹25份、桂枝90份、红花30份、陈皮75份。
或:
黄芪150份、附子120份、人参或党参75份、丹参225份、葶苈子50份、香加皮或南五加皮180份、泽泻75份、玉竹75份、桂枝30份、红花90份、陈皮25份。
或:
黄芪250份、附子112.5份、人参或党参200份、丹参120份、葶苈子135份、香加皮或南五加皮150份、泽泻200份、玉竹60份、桂枝75份、红花75份、陈皮60份。
本发明还提供了上述中药组合物的活性成分由下列成分组成:
(1)将黄芪、葶苈子、泽泻、人参或党参、香加皮或南五加皮用7-9倍量70%乙醇提取,滤过,浓缩提取液至在60℃热测时相对密度为1.25-1.30的清膏;
(2)水蒸汽蒸馏法提取桂枝、陈皮的挥发油;
(3)附子、丹参、玉竹、红花加6-10倍量水煎煮2次,每次2小时,合并提取液,滤过;桂枝、陈皮提油后的水溶液滤过,备用,提油后的药材残渣再加6-10倍量水煎煮1小时,滤过,合并水溶液;将上述所得的各种水溶液合并,浓缩至相对密度为1.25-1.30清膏,搅拌中加入乙醇,至醇浓度70%,静置,滤过,滤液浓缩至在60℃热测时相对密度为1.25-1.30的清膏;
步骤(1)所得的醇提清膏,步骤(2)所得挥发油与步骤(3)所得的水提清膏共同构成本发明中药组合物的活性成分。
本发明还公开了含有上述中药组合物作为活性组分的药物制剂为胶囊剂、片剂、丸剂、口服液、软胶囊或滴丸剂。
本发明中药组合物中,作为活性组分的原料药的拉丁名及其加工方法来自《中药大辞典》(1977年7月,第一版,上海科学技术出版社)和《中国药典》(2005年版,化学工业出版社)。
本发明中药组合物还可以按常规的制剂工艺,例如,范碧亭《中药药剂学》(上海科学出版社1997年12月第1版)记载的制备工艺,制成药剂学可接受的任意常规剂型,例如胶囊剂、片剂、丸剂、口服液、软胶囊、滴丸等。
本发明的应用中,所述中药组合物为胶囊剂、片剂、丸剂、口服液、软胶囊、滴丸制剂中的一种,为使上述剂型能够实现,需在制备这些剂型时加入药学可接受的辅料,例如:填充剂、崩解剂、润滑剂、助悬剂、粘合剂、甜味剂、矫味剂、防腐剂、基质等。填充剂包括:淀粉、预胶化淀粉、乳糖、甘露醇、甲壳素、微晶纤维素、蔗糖等;崩解剂包括:淀粉、预胶化淀粉、微晶纤维素、羧甲基淀粉钠、交联聚乙烯吡咯烷酮、低取代羟丙纤维素、交联羧甲基纤维素钠等;润滑剂包括:硬脂酸镁、十二烷基硫酸钠、滑石粉、二氧化硅等;助悬剂包括:聚乙烯吡咯烷酮、微晶纤维素、蔗糖、琼脂、羟丙基甲基纤维素等;粘合剂包括,淀粉浆、聚乙烯吡咯烷酮、羟丙基甲基纤维素等;甜味剂包括:糖精钠、阿斯帕坦、蔗糖、甜蜜素、甘草次酸等;矫味剂包括:甜味剂及各种香精;防腐剂包括:尼泊金类、苯甲酸、苯甲酸钠、山梨酸及其盐类、苯扎溴铵、醋酸氯乙定、桉叶油等;基质包括:PEG6000,PEG4000,虫蜡等。为使上述剂型能够实现中药药剂学,需在制备这些剂型时加入药学可接受的其它辅料(范碧亭《中药药剂学》,上海科学出版社1997年12月第1版中各剂型记载的辅料)。
本发明胶囊剂优选通过以下制备方法制成:
(1)将黄芪、葶苈子、泽泻、人参或党参、香加皮或南五加皮按照比例量称取加8倍量70%乙醇回流提取2次,第一次3小时,第二次2小时,合并提取液,滤过,滤液减压回收乙醇,浓缩至相对密度为1.25-1.30 (60℃热测)的清膏,备用;
(2)桂枝、陈皮按照比例蒸馏提取挥发油,提油后的水溶液滤过,备用,残渣再加8倍量水煎煮1小时,滤过,合并水煎液,备用;
(3)附子、丹参、玉竹、红花加水9倍量煎煮2次,每次2小时,合并提取液,滤过,与步骤(2)中桂枝、陈皮水煎液合并,浓缩至相对密度为1.25-1.30 (60℃热测)清膏,搅拌中加入乙醇,至醇浓度70%,4℃以下静置24小时,滤过,滤液减压回收乙醇,浓缩至相对密度为1.25-1.30 (60℃热测)清膏,与步骤(1)的醇提清膏混合,65-70℃烘干;
(4)将步骤(3)所得干膏混合粉碎成100目粉,加70%乙醇适量制粒,喷入桂枝、陈皮挥发油,混匀,装胶囊,即得。
优选的本发明所述痴呆为肝肾亏虚型痴呆。
优选的本发明所述痴呆为心肝火旺型痴呆。
优选的本发明所述痴呆为气滞血瘀型痴呆。
试验例:为阐明本发明中药组合物治疗痴呆的活性,用按实施例1方法所制得的药物(以下称本发明药物)进行了下列试验。
一般资料
选择2015年3月至2018年2月来我院(以岭医院)就诊的186例被确诊为痴呆的患者,随机分为两组。治疗组93例,男55例,女38例,年龄48-77岁,平均(61±4.1)岁,气滞血瘀型痴呆33例,肝肾亏虚型痴呆23例,心肝火旺型痴呆16例,脾肾两虚型痴呆11例,髓海不足型痴呆2例痰浊阻窍型痴呆3例,不明原因5例;对照组93例,男53例,女40例,年龄46-78岁,平均(62±5.3)岁,气滞血瘀型痴呆26例,肝肾亏虚型痴呆25例,心肝火旺型痴呆11例,脾肾两虚型痴呆17例,髓海不足型痴呆3例痰浊阻窍型痴呆6例,不明原因5例,2组患者一般资料比较,差异无统计意义(P>0.05) ,具有可比性。
治疗方法
2.1 中医诊断标准:(1)记忆:记忆能力,包括记忆近事及远事的能力减弱;(2)判定:判定认知人物、物品、时间、地点能力减退;(3)计算:计算数字,倒述数字能力减退;(4)识别:识别空间位置和结构能力减退;(5)语言:口语能力,包括理解别人语言能力和有条理地回答问题的能力障碍。文化程度高者阅读、书写能力障碍;(6)个性:心情孤僻,表情淡漠,语言啰嗦重复,自私狭隘,顽固固执,或无理由欣快,易于激动或暴怒等;(7)思维:抽象思维能力下降,例如不能解释谚语、区别词语的相同点和不同点,不能给事物下定义等;(8)人格:性格特征改变,道德伦理缺乏,不知羞耻。(9)年龄:多见于60岁以上;(10):病起发展缓慢、病程长,参考《中医病证诊断疗效标准》。
纳入和排除标准:符合中医诊断标准者,纳入临床试验研究。排除病例标准为:(1)年龄在18岁以下或80岁以上,过敏体质以及对本药过敏者;(2)合并心血管、肝、肾和造血系统等严重原发性疾病,精神病患者;(3)不符合纳入标准,未按规定用药,无法判断疗效,或资料不全等影响疗效或安全性判断者。
用药方案:对照组:口服盐酸多奈哌齐片(江苏豪森药业股份有限公司) ,一日一次,一次1片(以盐酸多奈哌齐计5mg),治疗组在对照组的基础上加服本发明药物,一日三次,每次4粒,疗程3个月,治疗3月后判定疗效。
观察指标
参照《中医病证诊断疗效标准》制定本次试验的疗效判定标准:临床控制:主要症状基本恢复正常,定向健全,回答问题正确,生活自理,能恢复一般社会活动。显效:主要症状大部分恢复正常,定向基本健全,回答问题基本正确,反应一般,生活可自理。有效:主要精神症状有所减轻或部分消失,生活基本自理,回答问题基本正确,但反应迟钝,智力与人格仍有障碍。无效:主要症状无改变甚至继续发展。对比两组的临床疗效,总有效率=临床控制率+显效率+有效率。
统计方法
采用SPSS17.0 统计软件处理数据,等级资料采用秩和检验,计数资料运用χ2 检验,P<0.05差异具有统计学意义。
结果
5.1 疾病疗效比较 试验组显效率58.1%,总有效率97.9%,无效率2.1%;对照组显效率24.7%,总有效率80.6%,无效率19.4%,两组比较差异有统计学意义(P<0.05),详见表1。
本研究在西药常规治疗的基础上,加入本发明药物治疗,治疗痴呆、在显效率58.1%、总有效率97.9%、无效率2.1%明显的优于对照组,充分证实本发明药物对各种原因引起的老年痴呆具有显著的临床疗效。
5.2 不良反应比较:治疗组在治疗过程中,未出现腹泻、头晕、头疼不良反应,出现恶性、呕吐现象的仅仅2例,对照组在治疗中出现了腹泻等多种不良反应,具体见下表:
由上表的结果可知,虽然治疗组也服用了盐酸多奈哌齐片,但是在试验过程中发生不良反应的情况明显少于单独使用盐酸多奈哌齐片,说明本发明药物可以有效的减轻盐酸多奈哌齐片的不良反应,特别是减轻盐酸多奈哌齐片引起的腹泻、头晕、头疼具有显著的效果,在减少恶心、呕吐、失眠方面也有较好的效果。
具体实施方式
实施例1:本发明药物胶囊剂的制备
处方:黄芪450g 附子112.5g 人参225g 丹参225g 葶苈子150g 香加皮180g 泽泻225g红花90g 玉竹75g 陈皮75g 桂枝90g
制备方法:
(1)按照上述处方将黄芪、葶苈子、泽泻、人参、香加皮加8倍量70%乙醇回流提取2次,第一次3小时,第二次2小时,合并提取液,滤过,滤液减压回收乙醇,浓缩至相对密度为1.25-1.30 (60℃热测)的清膏,备用;
(2)按照处方称取桂枝、陈皮蒸馏提取挥发油,提油后的水溶液滤过,备用,残渣再加8倍量水煎煮1小时,滤过,合并水煎液,备用;
(3)按照处方称取附子、丹参、玉竹、红花加水9倍量煎煮2次,每次2小时,合并提取液,滤过,与步骤(2)中桂枝、陈皮水煎液合并,浓缩至相对密度为1.25-1.30 (60℃热测)清膏,搅拌中加入乙醇,至醇浓度70%,4℃以下静置24小时,滤过,滤液减压回收乙醇,浓缩至相对密度为1.25-1.30 (60℃热测)清膏,与步骤(1)的醇提清膏混合,65-70℃烘干;
(4)将步骤(3)所得干膏混合粉碎成100目粉,加70%乙醇适量制粒,喷入桂枝、陈皮挥发油,混匀,装胶囊,制成1000粒,即得。
实施例2:本发明药物片剂的制备
处方:黄芪150g 附子40g 人参225g 丹参225g 葶苈子50g 香加皮180g 泽泻75g 玉竹75g 桂枝30g 红花90g 陈皮25g
制备方法:
(1)按照上述处方将黄芪、葶苈子、泽泻、人参、香加皮加8倍量70%乙醇回流提取2次,第一次3小时,第二次2小时,合并提取液,滤过,滤液减压回收乙醇,浓缩至相对密度为1.25-1.30 (60℃热测)的清膏,备用;
(2)按照上述处方桂枝、陈皮蒸馏提取挥发油,提油后的水溶液滤过,备用,残渣再加8倍量水煎煮1小时,滤过,合并水煎液,备用;
(3)按照上述处方附子、丹参、玉竹、红花加水9倍量煎煮2次,每次2小时,合并提取液,滤过,与步骤(2)中桂枝、陈皮水煎液合并,浓缩至相对密度为1.25-1.30 (60℃热测)清膏,搅拌中加入乙醇,至醇浓度70%,4℃以下静置24小时,滤过,液减压回收乙醇,浓缩至相对密度为1.25-1.30 (60℃热测)清膏,与步骤(1)的醇提清膏混合,65-70℃烘干;
(4)按常规制剂方法制成片剂。
实施例3:本发明药物口服液的制备
处方:黄芪250g附子112.5g 党参200g 丹参120g 葶苈子135g 南五加皮150g 泽泻200g 玉竹60g 桂枝75g 红花75g 陈皮60g
制备方法:按常规制剂方法制成口服液。
Claims (10)
1.一种中药组合物在制备治疗痴呆药物中的应用,其特征在于,所述中药组合物由如下重量份的原料药制成:
黄芪 150-450份、附子40-120份、人参或党参75-225份、丹参75-225份、葶苈子50-150份、香加皮或南五加皮60-180份、泽泻75-225份、
玉竹25-75份、桂枝30-90份、红花30-90份、陈皮25-75份。
2.如权利要求1所述的应用,其特征在于,所述中药组合物由如下重量份的原料药制成:
黄芪450份、附子40份、人参或党参225份、丹参75份、
葶苈子150份、香加皮或南五加皮60份、泽泻225份、玉竹25份、
桂枝90份、红花30份、陈皮75份。
3.如权利要求1所述的应用,其特征在于,所述中药组合物由如下重量份的原料药制成:
黄芪150份、附子120份、人参或党参75份、丹参225份、
葶苈子50份、香加皮或南五加皮180份、泽泻75份、玉竹75份、
桂枝30份、红花90份、陈皮25份。
4.如权利要求1所述的应用,其特征在于,所述中药组合物由如下重量份的原料药制成:
黄芪250份、附子112.5份、人参或党参200份、丹参120份、
葶苈子135份、香加皮或南五加皮150份、泽泻200份、玉竹60份、
桂枝75份、红花75份、陈皮60份。
5.如权利要求1-4中任一项所述的应用,其特征在于:所述中药组合物的活性成分由下列成分组成:
(1)将黄芪、葶苈子、泽泻、人参或党参、香加皮或南五加皮用7-9倍量70%乙醇提取,滤过,浓缩提取液至在60℃热测时相对密度为1.25-1.30的清膏;
(2)水蒸汽蒸馏法提取桂枝、陈皮的挥发油;
(3)附子、丹参、玉竹、红花加6-10倍量水煎煮2次,每次2小时,合并提取液,滤过;桂枝、陈皮提油后的水溶液滤过,备用,提油后的药材残渣再加6-10倍量水煎煮1小时,滤过,合并水溶液;将上述所得的各种水溶液合并,浓缩至相对密度为1.25-1.30清膏,搅拌中加入乙醇,至醇浓度70%,静置,滤过,滤液浓缩至在60℃热测时相对密度为1.25-1.30的清膏;
步骤(1)所得的醇提清膏,步骤(2)所得挥发油与步骤(3)所得的水提清膏共同构成本发明中药组合物的活性成分。
6.如权利要求1-4中任一项所述的应用,其特征在于:所述中药组合物的制剂剂型为胶囊剂、片剂、丸剂、口服液或滴丸剂。
7.根据权利要求6所述药物胶囊剂的制备方法,其特征在于,它是由以下步骤制成的:
(1)按照比例称取黄芪、葶苈子、泽泻、人参或党参、香加皮或南五加皮,加8倍量70%乙醇回流提取2次,第一次3小时,第二次2小时,合并提取液,滤过,滤液减压回收乙醇,浓缩至相对密度在60℃热测为1.25-1.30的清膏,备用;
(2)水蒸汽蒸馏法提取桂枝、陈皮的挥发油:按照比例称取桂枝、陈皮,提取挥发油,收集挥发油备用,提油后的水溶液滤过,备用,残渣再加8倍量水煎煮1小时,滤过,合并水煎液,备用;
(3)按照比例称取附子、丹参、玉竹、红花加水9倍量煎煮2次,每次2小时,合并提取液,滤过,与步骤(2)中桂枝、陈皮水煎液合并,浓缩至相对密度在60℃热测为1.25-1.30清膏,搅拌中加入乙醇,至醇浓度70%,4℃以下静置24小时,滤过,滤液减压回收乙醇,浓缩至相对密度在60℃热测为1.25-1.30清膏,与步骤(1)的醇提清膏混合,65-70℃烘干;
(4)将步骤(3)所得干膏粉碎成100目粉,加70%乙醇适量制粒,喷入桂枝、陈皮挥发油,混匀,装胶囊,即得。
8.如权利要求1-4中任一项所述的应用,其特征在于,所述痴呆为气滞血瘀型痴呆。
9.如权利要求1-4中任一项所述的应用,其特征在于,所述痴呆为肝肾亏虚型痴呆。
10.如权利要求1-4中任一项所述的应用,其特征在于,所述痴呆为心肝火旺型痴呆。
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