CN104940777A - 一种治疗肝旺脾弱型经行泄泻的冲剂及其制备方法 - Google Patents
一种治疗肝旺脾弱型经行泄泻的冲剂及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗肝旺脾弱型经行泄泻的冲剂及其制备方法,所述中药成分由以下原料药组成:柴胡、青皮、香附、柚核、党参、合欢花、白术、豆黄、佛手花、艾叶、云朴、茯苓、草果药、薏苡仁、肉豆蔻、益智仁、大枣、石蜜、当归、甘草。本发明的冲剂对肾阳亏虚型经行泄泻疗效明确,对症性强,专病专治,且其中的有效成分能迅速被吸收,快速有效,具有疏肝理气、健脾益气、温胃化湿、涩肠止泻之功,对身体具有很好的调理作用。
Description
技术领域
本发明属于中药技术领域,具体涉及一种治疗肝旺脾弱型经行泄泻的冲剂及其制备方法。
背景技术
经行泄泻,是指以经期或行经前后,周期性出现大便泄泻,日行数次为主要表现的月经期疾病,称为“经行泄泻”,亦称“经来泄泻”。多发于行经期妇女。主要发病机理是脾肾阳气不足,运化失司,值经期血气下注冲任,脾肾愈虚而发生泄泻。常见分型有肝郁脾虚、肾阳亏虚和肝旺脾弱。
1.肝郁脾虚:素体脾虚,或忧思劳倦,饮食不节。脾气受损,经行之际,气血下注冲任,脾气更虚,运化失司,故水湿内停,下走大肠,遂致泄泻。
2.肾阳亏虚:素禀肾虚,或房劳多产,命门火衰,经行之际,气血下注冲任,命火愈衰,不能上温于脾,脾失健运,遂致泄泻。
3.肝旺脾弱:肝主藏血,其性喜疏泄条达,如因肝气郁结,肝郁横逆,克制脾气,则运化乏力,而脾气益虚冰温下流,亦可引起经行泄泻。
临床上治疗经行泄泻较为棘手,治疗该病主要采用激素类等快速止泄药治疗,副作用大,治标不治本,因此广大患者亟需一种能够标本兼治、无副作用的药物来治疗经行泄泻。
发明内容
本发明的目的是提供一种治疗肝旺脾弱型经行泄泻的冲剂及其制备方法,本发明的冲剂对肝旺脾弱型经行泄泻疗效明确,对症性强,专病专治,且其中的有效成分能迅速被吸收,快速有效。
为了实现上述目的,本发明提供的技术方案是:
一种治疗肝旺脾弱型经行泄泻的冲剂,所述中药成分由以下重量份数的原料药组成:柴胡20-40份、青皮20-40份、香附20-30份、柚核10-20份、党参15-25份、合欢花15-25份、白术3-10份、豆黄10-18份、佛手花8-16份、艾叶6-14份、云朴6-12份、茯苓8-16份、草果药6-12份、薏苡仁6-12份、肉豆蔻6-12份、益智仁6-12份、大枣8-16份、石蜜8-16份、当归8-16份、甘草6-12份。
进一步的,所述中药成分由以下重量份数的原料药组成:柴胡25-35份、青皮25-35份、香附22-28份、柚核12-18份、党参17-22份、合欢花17-23份、白术5-7份、豆黄12-16份、佛手花10-14份、艾叶8-12份、云朴8-10份、茯苓10-14份、草果药8-10份、薏苡仁8-10份、肉豆蔻8-10份、益智仁8-10份、大枣10-14份、石蜜10-14份、当归10-14份、甘草8-11份。
进一步的,所述中药成分由以下重量份数的原料药组成:柴胡30份、青皮30份、香附25份、柚核15份、党参20份、合欢花20份、白术7份、豆黄14份、佛手花12份、艾叶10份、云朴9份、茯苓12份、草果药9份、薏苡仁9份、肉豆蔻9份、益智仁9份、大枣12份、石蜜12份、当归12份、甘草9份。
本发明还提供一种治疗肝旺脾弱型经行泄泻的冲剂的制备方法,包括以下步骤:
(1)将柴胡、青皮、香附、柚核、党参、合欢花、白术、佛手花、艾叶、云朴、茯苓、草果药、益智仁、当归、甘草分别研磨粉碎至50目,加入乙醇直至乙醇的量为上述中药材粉末的4-6倍,然后进行回流提取2-3h,收集提取液和滤渣,回收乙醇,将滤渣加3-5倍水煎煮1-2h,收集滤液,合并两次滤液;
(2)将步骤(1)制得的滤液与1/2质量的石蜜混合并搅拌均匀,将混合液进行喷雾干燥,并过80目筛,得到混合药粉I;
(3)取净肉豆蔻、薏苡仁,加入麸皮,每100份用麸皮40份,麸煨温度150-160℃,约15分钟,至麸皮呈焦黄色,肉豆蔻呈棕褐色,裹面有裂隙时取出,筛去麸皮,放凉备用;
(4)将将剩余1/2质量的石蜜粉碎与大枣肉用小火炒制,然后与豆黄、步骤(3)处理后的肉豆蔻、薏苡仁混合,研末并过80目筛,得到混合药粉II;
(5)将步骤(2)制得的混合药粉I、步骤(4)制得的混合药粉II混合均匀得混合药粉,即得所述的治疗肝旺脾虚型经行泄泻的冲剂。
使用方法:每日两次,每次10g,用温开水冲开,口服。
药理作用:
柴胡:入药部位为伞形科植物柴胡或狭叶柴胡的干燥根。味辛、苦,性微寒。归肝、胆、肺经。和解表里,疏肝解郁,升阳举陷,退热截疟。用于感冒发热,寒热往来,胸胁胀痛,月经不调,子宫脱垂,脱肛;青皮:入药部位为植物的干燥幼果或未成熟果实的果皮。味苦、辛,性温。归肝、胆、胃经。有疏肝破气,消积化滞的功效。用于胸胁胀痛,疝气疼痛,乳癖,乳痈,食积气滞,脘腹胀痛;香附:入药部位为植物的干燥根茎。辛、微苦、微甘,平。归肝、脾、三焦经。疏肝解郁,理气宽中,调经止痛。用于肝郁气滞,胸胁胀痛,疝气疼痛,乳房胀痛,脾胃气滞,脘腹痞闷,胀满疼痛,月经不调,经闭痛经;柚核:入药部位为芸香科植物柚的种子。含黄柏酮、黄柏内酯、去乙酰闹米林。另有记载:种子含脂肪油40.74%,灰分2.85%。蛋白质23.87%,非氮物质11.51%,粗纤维3.09%。苦,平,温。归肝经。疏肝理气,宣肺止咳。主疝气肺寒咳嗽;党参:为桔梗科植物党参、素花党参、川党参、管花党参、球花党参、徽毛党参的根。《本草再新》:甘,平,无毒。《中国药典》:归脾、肺经。补中,益气,生津。治脾胃虚弱,气血两亏,体倦无力,食少,口渴,久泻,脱肛。不宜与藜芦同用;合欢花:性味甘,平。含有合欢甙,鞣质,解郁安神,滋阴补阳,理气开胃,活络止痛,用于、忧郁失眠。治郁结胸闷,失眠,健忘,风火眼,能安五脏,和心志,悦颜色,有较好的强身、镇静、安神、美容的作用,是治疗神经衰弱的佳品。具有清热解暑,养颜祛斑解酒等功效;白术:味苦,甘,性温。归脾、胃经。健脾益气,燥湿利水,止汗,安胎。用于脾虚食少,腹胀泄泻,痰饮眩悸,水肿,自汗,胎动不安。土白术健脾,和胃,安胎。用于脾虚食少,泄泻便溏,胎动不安;豆黄:《纲目》:甘,温,无毒。归脾,胃经。祛风除湿,健脾益气。主湿痹,关节疹痛,脾虚食少,胃脘妨闷,阴囊湿痒。盂诜:主湿痹、膝痛,五藏不足气,胃气结积,益气,润肌肤。末之收盛,炼猪膏为丸服之,能肥健人;佛手花:入药部位为为芸香科植物佛手的花朵和花蕾。微苦,微温。归肝,胃经。疏肝理气,和胃快隔。《药材资料汇编》:“平肝胃气痛。”;艾叶:入药部位为植物的干燥叶。辛、苦,温。归肝、脾、肾经。温经止血,散寒止痛;外用祛湿止痒。用于吐血,衄血,崩漏,月经过多,胎漏下血,少腹冷痛,经寒不调,宫冷不孕;外治皮肤瘙痒。醋艾炭温经止血,用于虚寒性出血;云朴:入药部位为本兰科植物滇缅厚朴的干皮、根皮及枝皮。皮中含和厚朴酚,厚朴酚,木兰箭毒碱,挥发油,油中含β-桉叶醇。辛,苦,性温。归脾,胃,肺,大肠经。温中化湿,行气消积。主胸腹胀满疼痛,食积气滞,呕吐,腹泻,痰多咳嗽;茯苓:入药部位为真菌的干燥菌核。味甘、淡,性平。归心、肺、脾、肾经。利水渗湿,健脾,宁心。用于水肿尿少,痰饮眩悸,脾虚食少,便溏泄泻,心神不安,惊悸失眠;草果药:种子供药用。《滇南本草》:“性大温,味辛微苦。”温胃,燥湿,理气,消食。《云南中草药》:“温胃散寒,燥湿,治胃寒痛,消化不良,疟疾。”;薏苡仁:入药部位为植物的干燥成熟种仁。味甘、淡,性凉。归脾、胃、肺经。有利水渗透湿,健脾止泻,除痹,排脓,解毒散结的作用。用于水肿,脚气,小便不利,脾虚泄泻,湿痹拘挛,肺痈,肠痈;赘疣,癌肿;肉豆蔻:入药部位为干燥种仁。味辛,性温。归脾、胃、大肠经。温中行气,涩肠止泻。用于脾胃虚寒,久泻不止,脘腹胀痛,食少呕吐。《本草正义》:“肉豆蔻,除寒燥湿,解结行气,专理脾胃,颇与草果相近,则辛温之功效本同,惟涩味较甚,并能固及大肠之滑脱,四神丸中有之。温脾即以温肾,是为中下两焦之药,与草果之专主中焦者微别。”;益智仁:入药部位为为姜科植物益智的干燥成熟果实。味辛,性温。入心,脾,肾经。温肾固精缩尿,温脾开胃摄唾。主治脾胃虚寒,呕吐,泄泻,腹中冷育,口多唾涎,肾虚遗尿,尿频,遗精,白浊,多唾液等症。益智仁含挥发油、益智仁酮、维生素B1、维生素B2、维生素C、维生素E及多种氨基酸、脂肪酸等。益智仁煎剂具有健胃、抗利尿、减少唾液分泌的作用;大枣:味甘,性温,无毒。补中益气,养血安神。用于脾虚食少,乏力便溏,妇人脏躁。预防输血反应,降低血清谷丙转氨酶,抗肿瘤,抗氧化,降血压、降胆固醇,保肝护肝,提高免疫力,防治脑供血不足,抗过敏,防治心血管病,防治骨质疏松和贫血;石蜜:石蜜指甘蔗汁经过太阳暴晒后而成的固体原始蔗糖。甘、平、无毒。具有润肺化痰、治诸咳、按五脏不足、健胃消食、胃痛、胃病十二指肠溃疡、止痛解毒、类外风湿关节痛、贫血、妇科病等有奇效。能和百药除众病养脾气除心烦。久服能强志轻身,不饥不老、容颜、养颜令人光泽、面如红花,是有病治病,无病强身的极好佳品;当归:入药部位为伞形科植物当归的干燥根。味甘、辛,性温。归肝、心、脾经。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,风湿痹痛,跌扑损伤,痈疽疮疡,肠燥便秘。酒当归活血通经。用于经闭痛经,风湿痹痛,跌扑损伤;甘草:味甘,气平,性缓。入足太阴脾、足阳明胃经。备冲和之正味,秉淳厚之良资,入金木两家之界,归水火二气之间,培植中州,养育四旁,交媾精神之妙药,调济气血之灵丹。补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。
中医学认为,肝主藏血,其性喜疏泄条达,如因肝气郁结,肝郁横逆,肝气郁结则疏泄不利,脾气亦因之运化失职,克制脾气,则运化乏力,而脾气益虚冰温下流,亦可引起经行泄泻,经前或经行大便溏薄或泄泻,倦怠乏力,少腹、胸胁胀痛,腹痛即泻。苔薄白,舌淡,脉细而弦。
基于上述中医理论,本发明以疏肝理气、健脾益气、温胃化湿、涩肠止泻为治疗原则。肝主藏血,其性喜疏泄条达,如因肝气郁结,肝郁横逆,克制脾气,则运化乏力,而脾气益虚冰温下流,则可引起经行泄泻。所以方中以柴胡、青皮、香附、柚核疏肝理气的药物为君药,其中柴胡能和解表里、疏肝解郁、升阳举陷,青皮有疏肝破气、消积化滞的功效,香附疏肝解郁、理气宽中、调经止痛,柚核疏肝理气、宣肺止咳,此四味药共奏疏肝理气之功,针对肝气郁结、肝郁横逆克制脾气以疏肝解郁、理气宽中,使肝气疏通,肝火熄灭,肝气正常生发、顺调;党参、合欢花、白术、豆黄健脾益气的药物为臣药,其中党参补中益气,合欢花解郁安神,滋阴补阳,理气开胃,活络止痛,白术健脾益气,燥湿利水,豆黄祛风除湿,健脾益气,针对肝郁横逆,克制脾气,此四味药共奏健脾益气之功;佛手花、艾叶、云朴、茯苓、草果药、薏苡仁、肉豆蔻、益智仁温胃化湿、涩肠止泻的药物为佐药,其中佛手花疏肝理气,艾叶温经止血,散寒止痛,云朴温中化湿,行气消积,茯苓利水渗湿,健脾宁心,草果药温胃燥湿,理气消食,薏苡仁有利水渗透湿,健脾止泻的作用,肉豆蔻温中行气,涩肠止泻,益智仁能温肾固精缩尿,温脾开胃摄唾,针对运化乏力,而脾气益虚冰温下流,引起经行泄泻而行温胃化湿、涩肠止泻之功,且薏苡仁与茯苓、白术合用能渗除脾湿,健脾止泻;方中大枣、石蜜、当归、甘草为使药,大枣能补中益气、养血安神,石蜜能和百药除众病养脾气,当归归肝、心、脾经,补血活血,调经止痛,润肠通便,甘草补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药,石蜜与甘草配合调和诸药效果更佳,党参其味甘,能补中益气,又能益智宁神,配伍红枣养血和中,使脾胃健康而除水湿,当归与柴胡配合能引药入肝,使药物快速发挥药效,助诸药疏肝理气、健脾益气、除中焦之湿气,理脾胃以止泻,脾气健运,湿浊乃化,泄泻遂止。
本发明的有益效果是:
(1)本发明是在传统中医理论和临床经验指导下,精选的药物组方符合中医理论和中华人民共和国药典要求,对人体无毒副作用,所有原药料按照君臣佐使的原则协调在一起克最大程度发挥药效,共奏疏肝理气、健脾益气、温胃化湿、涩肠止泻之功,达到治疗肝旺脾弱型经行泄泻的目的;
(2)本发明制备成颗粒冲剂,并添加柴胡、当归,能引药入脾,能快速发挥药效,助诸药疏肝理气、健脾益气、除中焦之湿气,理脾胃以止泻,脾气健运,湿浊乃化,泄泻遂止;
(3)本发明的冲剂在治疗上辨证施治,针对肝旺脾弱型经行泄泻疗效明确,对症性强,专病专治,且标本兼治,对身体有良好的调理作用。
具体实施方式
下面将结合本发明的实施例,对本发明的技术方案进行清楚、完整地描述。
实施例1
一种治疗肝旺脾弱型经行泄泻的冲剂,所述中药成分由以下重量份数的原料药组成:柴胡20份、青皮20份、香附20份、柚核10份、党参15份、合欢花15份、白术3份、豆黄10份、佛手花8份、艾叶6份、云朴6份、茯苓8份、草果药6份、薏苡仁6份、肉豆蔻6份、益智仁6份、大枣8份、石蜜8份、当归8份、甘草6份。
所述治疗肝旺脾弱型经行泄泻的冲剂的制备方法,包括以下步骤:
(1)将柴胡、青皮、香附、柚核、党参、合欢花、白术、佛手花、艾叶、云朴、茯苓、草果药、益智仁、当归、甘草分别研磨粉碎至50目,加入乙醇直至乙醇的量为上述中药材粉末的4倍,然后进行回流提取2h,收集提取液和滤渣,回收乙醇,将滤渣加3倍水煎煮1h,收集滤液,合并两次滤液;
(2)将步骤(1)制得的滤液与1/2质量的石蜜混合并搅拌均匀,将混合液进行喷雾干燥,并过80目筛,得到混合药粉I;
(3)取净肉豆蔻、薏苡仁,加入麸皮,每100份用麸皮40份,麸煨温度150℃,约15分钟,至麸皮呈焦黄色,肉豆蔻呈棕褐色,裹面有裂隙时取出,筛去麸皮,放凉备用;
(4)将将剩余1/2质量的石蜜粉碎与大枣肉用小火炒制,然后与豆黄、步骤(3)处理后的肉豆蔻、薏苡仁混合,研末并过80目筛,得到混合药粉II;
(5)将步骤(2)制得的混合药粉I、步骤(4)制得的混合药粉II混合均匀得混合药粉,即得所述的治疗肝旺脾虚型经行泄泻的冲剂。
使用方法:每日两次,每次10g,用温开水冲开,口服。
实施例2
一种治疗肝旺脾弱型经行泄泻的冲剂,所述中药成分由以下重量份数的原料药组成:柴胡40份、青皮40份、香附30份、柚核20份、党参25份、合欢花25份、白术10份、豆黄18份、佛手花16份、艾叶14份、云朴12份、茯苓16份、草果药12份、薏苡仁12份、肉豆蔻12份、益智仁12份、大枣16份、石蜜16份、当归16份、甘草12份。
所述治疗肝旺脾弱型经行泄泻的冲剂的制备方法,包括以下步骤:
(1)将柴胡、青皮、香附、柚核、党参、合欢花、白术、佛手花、艾叶、云朴、茯苓、草果药、益智仁、当归、甘草分别研磨粉碎至50目,加入乙醇直至乙醇的量为上述中药材粉末的6倍,然后进行回流提取3h,收集提取液和滤渣,回收乙醇,将滤渣加5倍水煎煮2h,收集滤液,合并两次滤液;
(2)将步骤(1)制得的滤液与1/2质量的石蜜混合并搅拌均匀,将混合液进行喷雾干燥,并过80目筛,得到混合药粉I;
(3)取净肉豆蔻、薏苡仁,加入麸皮,每100份用麸皮40份,麸煨温度160℃,约15分钟,至麸皮呈焦黄色,肉豆蔻呈棕褐色,裹面有裂隙时取出,筛去麸皮,放凉备用;
(4)将将剩余1/2质量的石蜜粉碎与大枣肉用小火炒制,然后与豆黄、步骤(3)处理后的肉豆蔻、薏苡仁混合,研末并过80目筛,得到混合药粉II;
(5)将步骤(2)制得的混合药粉I、步骤(4)制得的混合药粉II混合均匀得混合药粉,即得所述的治疗肝旺脾虚型经行泄泻的冲剂。
使用方法:每日两次,每次10g,用温开水冲开,口服。
实施例3
一种治疗肝旺脾弱型经行泄泻的冲剂,所述中药成分由以下重量份数的原料药组成:柴胡25份、青皮25份、香附22份、柚核12份、党参17份、合欢花17份、白术5份、豆黄12份、佛手花10份、艾叶8份、云朴8份、茯苓10份、草果药8份、薏苡仁8份、肉豆蔻8份、益智仁8份、大枣10份、石蜜10份、当归10份、甘草8份。
所述治疗肝旺脾弱型经行泄泻的冲剂的制备方法,包括以下步骤:
(1)将柴胡、青皮、香附、柚核、党参、合欢花、白术、佛手花、艾叶、云朴、茯苓、草果药、益智仁、当归、甘草分别研磨粉碎至50目,加入乙醇直至乙醇的量为上述中药材粉末的5倍,然后进行回流提取3h,收集提取液和滤渣,回收乙醇,将滤渣加5倍水煎煮2h,收集滤液,合并两次滤液;
(2)将步骤(1)制得的滤液与1/2质量的石蜜混合并搅拌均匀,将混合液进行喷雾干燥,并过80目筛,得到混合药粉I;
(3)取净肉豆蔻、薏苡仁,加入麸皮,每100份用麸皮40份,麸煨温度150℃,约15分钟,至麸皮呈焦黄色,肉豆蔻呈棕褐色,裹面有裂隙时取出,筛去麸皮,放凉备用;
(4)将将剩余1/2质量的石蜜粉碎与大枣肉用小火炒制,然后与豆黄、步骤(3)处理后的肉豆蔻、薏苡仁混合,研末并过80目筛,得到混合药粉II;
(5)将步骤(2)制得的混合药粉I、步骤(4)制得的混合药粉II混合均匀得混合药粉,即得所述的治疗肝旺脾虚型经行泄泻的冲剂。
使用方法:每日两次,每次10g,用温开水冲开,口服。
实施例4
一种治疗肝旺脾弱型经行泄泻的冲剂,所述中药成分由以下重量份数的原料药组成:柴胡35份、青皮35份、香附28份、柚核18份、党参22份、合欢花23份、白术7份、豆黄16份、佛手花14份、艾叶12份、云朴10份、茯苓14份、草果药10份、薏苡仁10份、肉豆蔻10份、益智仁10份、大枣14份、石蜜14份、当归14份、甘草11份。
所述治疗肝旺脾弱型经行泄泻的冲剂的制备方法,包括以下步骤:
(1)将柴胡、青皮、香附、柚核、党参、合欢花、白术、佛手花、艾叶、云朴、茯苓、草果药、益智仁、当归、甘草分别研磨粉碎至50目,加入乙醇直至乙醇的量为上述中药材粉末的4倍,然后进行回流提取2h,收集提取液和滤渣,回收乙醇,将滤渣加5倍水煎煮2h,收集滤液,合并两次滤液;
(2)将步骤(1)制得的滤液与1/2质量的石蜜混合并搅拌均匀,将混合液进行喷雾干燥,并过80目筛,得到混合药粉I;
(3)取净肉豆蔻、薏苡仁,加入麸皮,每100份用麸皮40份,麸煨温度160℃,约15分钟,至麸皮呈焦黄色,肉豆蔻呈棕褐色,裹面有裂隙时取出,筛去麸皮,放凉备用;
(4)将将剩余1/2质量的石蜜粉碎与大枣肉用小火炒制,然后与豆黄、步骤(3)处理后的肉豆蔻、薏苡仁混合,研末并过80目筛,得到混合药粉II;
(5)将步骤(2)制得的混合药粉I、步骤(4)制得的混合药粉II混合均匀得混合药粉,即得所述的治疗肝旺脾虚型经行泄泻的冲剂。
使用方法:每日两次,每次10g,用温开水冲开,口服。
实施例5
一种治疗肝旺脾弱型经行泄泻的冲剂,所述中药成分由以下重量份数的原料药组成:柴胡30份、青皮30份、香附25份、柚核15份、党参20份、合欢花20份、白术7份、豆黄14份、佛手花12份、艾叶10份、云朴9份、茯苓12份、草果药9份、薏苡仁9份、肉豆蔻9份、益智仁9份、大枣12份、石蜜12份、当归12份、甘草9份。
所述治疗肝旺脾弱型经行泄泻的冲剂的制备方法,包括以下步骤:
(1)将柴胡、青皮、香附、柚核、党参、合欢花、白术、佛手花、艾叶、云朴、茯苓、草果药、益智仁、当归、甘草分别研磨粉碎至50目,加入乙醇直至乙醇的量为上述中药材粉末的5倍,然后进行回流提取2.5h,收集提取液和滤渣,回收乙醇,将滤渣加4倍水煎煮1.5h,收集滤液,合并两次滤液;
(2)将步骤(1)制得的滤液与1/2质量的石蜜混合并搅拌均匀,将混合液进行喷雾干燥,并过80目筛,得到混合药粉I;
(3)取净肉豆蔻、薏苡仁,加入麸皮,每100份用麸皮40份,麸煨温度155℃,约15分钟,至麸皮呈焦黄色,肉豆蔻呈棕褐色,裹面有裂隙时取出,筛去麸皮,放凉备用;
(4)将将剩余1/2质量的石蜜粉碎与大枣肉用小火炒制,然后与豆黄、步骤(3)处理后的肉豆蔻、薏苡仁混合,研末并过80目筛,得到混合药粉II;
(5)将步骤(2)制得的混合药粉I、步骤(4)制得的混合药粉II混合均匀得混合药粉,即得所述的治疗肝旺脾虚型经行泄泻的冲剂。
使用方法:每日两次,每次10g,用温开水冲开,口服。
实施例6
急性经口毒性试验:
健康成年SD大鼠40只,雌雄各半,体重相当,均在220±10g之间,试验前16小时内禁食,然后将本发明的冲剂用温开水冲开后对大鼠用经口灌胃法多次染毒,灌胃剂量为5000mg(本发明冲剂)/kg体重,然后继续禁食3-4天,试验大鼠全身状况、饮食、饮水、体重增长均正常,未出现明显中毒现象和死亡现象,处死后解剖无明显异常,判断该中药组合物对大鼠急性经口毒性属实际无毒级。
长期毒性试验:
健康成年小鼠20只,体重18-22g,将本发明的冲剂颗粒掺在饲料中给小鼠喂养,小鼠食用量为52.8g生药/kg/天,连续喂养10周,停药3周后对小数的毛发、行为、大小便、体重、脏器重量、血象、肝肾功能、血糖、血脂进行检测,试验小鼠的毛发、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。组织学检查结果表明,用药10周及停药3周后,小鼠各脏器均无明显改变,说明本发明中药对小鼠长期用药后毒性小,停药后也没有异样反应,应用安全。
实施例7
临床试验研究:
1、临床资料
发明人共收集144例肝旺脾虚型经行泄泻患者,年龄19-46岁,平均年龄30.5岁。临床表现为经前或经行大便溏薄或泄泻,倦怠乏力,少腹、胸胁胀痛,腹痛即泻。苔薄白,舌淡,脉细而弦。
2、治疗方法
口服,每日两次,每次10g,用温开水冲开,口服。
一个月为一个疗程,治疗三个疗程后暂停一个月治疗,然后记录结果。
3、疗效评定
治愈:经行大便正常,无周期性发作。
好转:经行泄泻次数减少,症状减轻。或泄泻虽止,但3个月经周期内又复发者。
未愈:经行泄泻症状无变化。
4、治疗结果
经过两个疗程的治疗后,144例患者中,治愈115例,好转26例,未愈3例;经统计学分析治愈率达79.860%,总有效率达97.92%,并且在治疗过程中,未见任何不良反应或副作用,表明用药安全有效。停药后无复发。
5、典型病例
病例1:汤某,33岁,连续半年经前期大便泄泻,经行量多,倦怠乏力,少腹、胸胁胀痛,苔薄白,舌淡,脉细而弦,被诊断为肝旺脾虚型经行泄泻,服用本发明中药3个疗程后,症状明显缓解,继续服用本发明中药2个疗程后,各种症状基本消失,恢复正常,后又继续服用1个疗程巩固,痊愈,半年后随访无复发。
病例2:程某,22岁,连续数月经期大便溏泻,食少纳呆,脘腹胀闷,四肢倦怠,肠鸣失气,及胁胀痛,腹痛即泻,并苔薄白,舌淡,被诊断为肝旺脾弱型经行泄泻,服用本发明中药3个疗程后,症状明显缓解,继续服用本发明中药1个疗程后,各种症状基本消失,恢复正常,半年后随访无复发。
以上所述是本发明的优选实施方式,其目的在于让熟悉此项技术的人了解本发明内容并加以实施,应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明原理的前提下,还可以做出若干改进和润饰,这些改进和润饰也视为本发明的保护范围。
Claims (4)
1.一种治疗肝旺脾弱型经行泄泻的冲剂,其特征在于,所述中药成分由以下重量份数的原料药组成:柴胡20-40份、青皮20-40份、香附20-30份、柚核10-20份、党参15-25份、合欢花15-25份、白术3-10份、豆黄10-18份、佛手花8-16份、艾叶6-14份、云朴6-12份、茯苓8-16份、草果药6-12份、薏苡仁6-12份、肉豆蔻6-12份、益智仁6-12份、大枣8-16份、石蜜8-16份、当归8-16份、甘草6-12份。
2.如权利要求1所述的一种治疗肝旺脾弱型经行泄泻的冲剂,其特征在于,所述中药成分由以下重量份数的原料药组成:柴胡25-35份、青皮25-35份、香附22-28份、柚核12-18份、党参17-22份、合欢花17-23份、白术5-7份、豆黄12-16份、佛手花10-14份、艾叶8-12份、云朴8-10份、茯苓10-14份、草果药8-10份、薏苡仁8-10份、肉豆蔻8-10份、益智仁8-10份、大枣10-14份、石蜜10-14份、当归10-14份、甘草8-11份。
3.如权利要求1所述的一种治疗肝旺脾弱型经行泄泻的冲剂,其特征在于,所述中药成分由以下重量份数的原料药组成:柴胡30份、青皮30份、香附25份、柚核15份、党参20份、合欢花20份、白术7份、豆黄14份、佛手花12份、艾叶10份、云朴9份、茯苓12份、草果药9份、薏苡仁9份、肉豆蔻9份、益智仁9份、大枣12份、石蜜12份、当归12份、甘草9份。
4.如权利要求1-3任意一项所述的一种治疗肝旺脾弱型经行泄泻的冲剂的制备方法,其特征在于,包括以下步骤:
(1)将柴胡、青皮、香附、柚核、党参、合欢花、白术、佛手花、艾叶、云朴、茯苓、草果药、益智仁、当归、甘草分别研磨粉碎至50目,加入乙醇直至乙醇的量为上述中药材粉末的4-6倍,然后进行回流提取2-3h,收集提取液和滤渣,回收乙醇,将滤渣加3-5倍水煎煮1-2h,收集滤液,合并两次滤液;
(2)将步骤(1)制得的滤液与1/2质量的石蜜混合并搅拌均匀,将混合液进行喷雾干燥,并过80目筛,得到混合药粉I;
(3)取净肉豆蔻、薏苡仁,加入麸皮,每100份用麸皮40份,麸煨温度150-160℃,约15分钟,至麸皮呈焦黄色,肉豆蔻呈棕褐色,裹面有裂隙时取出,筛去麸皮,放凉备用;
(4)将将剩余1/2质量的石蜜粉碎与大枣肉用小火炒制,然后与豆黄、步骤(3)处理后的肉豆蔻、薏苡仁混合,研末并过80目筛,得到混合药粉II;
(5)将步骤(2)制得的混合药粉I、步骤(4)制得的混合药粉II混合均匀得混合药粉,即得所述的治疗肝旺脾虚型经行泄泻的冲剂。
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