CN108815360B - 一种治疗小儿急性扁桃体炎、急性咽炎的中药组合物及其制备方法 - Google Patents
一种治疗小儿急性扁桃体炎、急性咽炎的中药组合物及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗小儿急性扁桃体炎、急性咽炎的中药组合物及其制备方法,该中药组合物是由金银花、连翘、玄参、蒲公英、赤芍、黄芩、桑叶、菊花、前胡、苦杏仁、牛蒡子、泽泻、胖大海、浙贝母、蝉蜕、木蝴蝶共十六味原料药制备而成,本发明的优点在于与现有技术相比,本发明配伍合理、协同发挥作用、功效明确、在治疗小儿急性扁桃体炎、急性咽炎方面疗效更好;其药效学实验效果显著提高,且安全无任何毒副作用;长期服用安全性高,不会产生依赖性。
Description
技术领域
本发明属于制药技术领域,涉及一种治疗小儿急性扁桃体炎、急性咽炎的中药组合物及其制备方法。
背景技术
小儿急性扁桃体炎、急性咽炎属临床中比较常见和多发的一种疾病,临床主要表现为嗓子干疼、化脓、咳嗽、声音嘶哑等症状。目前药物治疗主要分为西医治疗和中医治疗,西医治疗主要以抗生素、非甾体抗炎药、抗组胺药为主,这些药品副作用比较常见,机体易产生耐受性,对小儿的健康很不利,中医在治疗小儿急性扁桃体炎、急性咽炎方面,主要以中成药为主,目前市场上大多数治疗效果不能令人满意,不能满足临床需要。
目前现有技术,1、《中药成方制剂第十八册保护品种分册二》第182页项下“金嗓开音丸”,公开了金嗓开音丸的处方用药材,无具体用量,未公开制备工艺;2、《中国药典2010年版一部》第832页项下“金嗓开音丸”,公开了金嗓开音丸的处方用药材,无具体用量,并公开了具体的制备工艺;3、《中国药典2015年版一部》第1088页项下“金嗓开音丸”,公开了金嗓开音丸的处方用药材,无具体用量,并公开了具体的制备工艺;4、新药转证标准第75册第33-34页项下“金嗓开音胶囊”,公开了金嗓开音胶囊的处方用药材,无具体用量,未公开制备工艺;以上现有技术1-4均为我公司独家品种“金嗓开音丸”及“金嗓开音胶囊”的公开技术资料,1和4均公开了一种相同的处方,但没有公开具体药材用量,并没有公开具体制备工艺。2和3均公开了一种相同的处方,但没有公开具体药材用量,并公开了具体制备工艺,工艺均为以上十六味粉碎成细粉,加入炼蜜制成水蜜丸或大蜜丸。5、2013年03月20日中国专利公报公开号为“CN102973746A”公开了由本申请人申请的发明名称为“一种疏风清热、利咽开音的中药复方提取物及其制剂”组成本发明所述中成药的复方提取物中各味药物原料的重量配比为“13%金银花、13%连翘、13%玄参、11%黄芩、5%桑叶、5%菊花、5%牛蒡子、5%蝉蜕、5%赤芍、5%苦杏仁、5%前胡、5%胖大海、5%木蝴蝶、5%泽泻,复方提取物与板蓝根细粉、麸炒僵蚕细粉的配比为:12%-98%:0-62%:0-25%,并公开了制备方法:以上十四种药材混合粉碎成粗粉,加入10倍量、8倍量70%乙醇回流提取,提取液浓缩成浸膏,喷雾干燥,制成复方提取物,加入0-62%板蓝根细粉、0-25%麸炒僵蚕细粉、蔗糖粉和糊精混合均匀,加入纯化水喷雾制粒、整粒、得颗粒剂;经申请人研究发现以上现有技术5的工艺较粗,经试验疗效也不理想。6、2004年11月10日中国专利公报公开号为“CN1544069A”公开了由本申请人申请的发明名称为“一种治疗急性咽喉炎的中药及其制备方法”组成本发明所述中成药的各味药物原料的重量配比为“金银花115-135份、连翘115-135份、玄参115-135份、板蓝根115-135份、赤芍40-60份、黄芩65-85份、桑叶40-60份、菊花40-60份、前胡40-60份、苦杏仁40-60份、牛蒡子40-60份、泽泻40-60份、胖大海40-60份、僵蚕40-60份、蝉蜕40-60份、木蝴蝶40-60份”;公开了一种有具体药材用量的处方及具体的制备方法;以上现有技术1-6都是治疗成人风热邪毒所致的咽喉肿痛,声音嘶哑,急性咽炎、急性喉炎;
在近几年的时间里,我们在以上1-6处方的基础上,对处方量进行了大量的试验摸索,意外的发现,在“CN1544069A”处方:“金银花115-135份、连翘115-135份、玄参115-135份、板蓝根115-135份、赤芍40-60份、黄芩65-85份、桑叶40-60份、菊花40-60份、前胡40-60份、苦杏仁40-60份、牛蒡子40-60份、泽泻40-60份、胖大海40-60份、僵蚕40-60份、蝉蜕40-60份、木蝴蝶40-60份”的基础上:“将板蓝根、僵蚕换成蒲公英和浙贝母后,在治疗小儿急性扁桃体炎、急性咽炎方面临床药效学试验效果显著提高,且对小儿无任何毒副作用。我们按照中药常规工艺制备成了颗粒剂、口服液及含片。
发明内容
本发明的目的在于提供一种疗效更为显著的一种治疗小儿急性扁桃体炎、急性咽炎的中药组合物及其制备方法,更好地解决了现有技术中的西药治疗机体易产生耐受性,中医在治疗治疗效果不佳,不能满足临床需要的现状等问题。
本发明所采用的技术方案是,
一种治疗小儿急性扁桃体炎、急性咽炎的中药组合物,它是由以下重量配比的中药原料制成的药剂:
金银花105-145份、连翘105-145份、玄参105-145份、蒲公英105-145份、赤芍30-70份、黄芩55-95份、桑叶30-70份、菊花30-70份、前胡30-70份、苦杏仁30-70份、牛蒡子30-70份、泽泻30-70份、胖大海30-70份、浙贝母30-70份、蝉蜕30-70份、木蝴蝶30-70份。
一种治疗小儿急性扁桃体炎、急性咽炎的中药组合物,它是由以下重量配比的中药原料制成的药剂:
金银花125份、连翘125份、玄参125份、蒲公英125份、赤芍50份、黄芩75份、桑叶50份、菊花50份、前胡50份、苦杏仁50份、牛蒡子50份、泽泻50份、胖大海50份、浙贝母50份、蝉蜕50份、木蝴蝶50份。
一种治疗小儿急性扁桃体炎、急性咽炎的中药组合物,所述的药剂是任何一种药剂学上所述的剂型。
一种治疗小儿急性扁桃体炎、急性咽炎的中药组合物,所述的剂型为颗粒剂、口服液、含片。
1.所述的剂型为颗粒剂的制备方法包括以下步骤:
步骤一:将苦杏仁去皮后,备用;
步骤二:将金银花、连翘、赤芍、苦杏仁、浙贝母粉碎成40-60目粗粉,用80%乙醇加热回流提取二次,每次2小时,合并提取液,滤过,滤液备用;
步骤三:将步骤二中的药渣与其余玄参、蒲公英、黄芩、桑叶、菊花、前胡、牛蒡子、泽泻、胖大海、蝉蜕、木蝴蝶共十一味加水煎煮二次,每次2小时,合并煎液,滤过,滤液浓缩至25℃时测得相对密度为1.28-1.30的清膏,加乙醇使含醇量达70%,搅拌均匀,静置,滤过,滤液与上述步骤二中的乙醇提取液合并,回收乙醇并浓缩至50℃时测得相对密度为1.05-1.10的清膏,加入糖粉和糊精,制粒,干燥,整粒,即得颗粒剂。
2.所述的剂型为口服液的制备方法包括以下步骤:
步骤一:将苦杏仁去皮后,备用;
步骤二:将金银花、连翘、赤芍、苦杏仁、浙贝母粉碎成40-60目粗粉,用80%乙醇加热回流提取二次,每次2小时,合并提取液,滤过,滤液备用;
步骤三:将步骤二中的药渣与其余玄参、蒲公英、黄芩、桑叶、菊花、前胡、牛蒡子、泽泻、胖大海、蝉蜕、木蝴蝶共十一味加水煎煮二次,每次2小时,合并煎液,滤过,滤液浓缩至25℃时测得相对密度为1.28-1.30的清膏,加乙醇使含醇量达70%,搅拌均匀,静置,滤过,滤液与上述步骤二中的乙醇提取液合并,回收乙醇并浓缩至50℃时测得相对密度为1.05-1.10的清膏,加入适宜辅料,制成口服液。
3.所述的剂型为含片的制备方法包括以下步骤:
步骤一:将苦杏仁去皮后,备用;
步骤二:将金银花、连翘、赤芍、苦杏仁、浙贝母粉碎成40-60目粗粉,用80%乙醇加热回流提取二次,每次2小时,合并提取液,滤过,滤液备用;
步骤三:将步骤二中的药渣与其余玄参、蒲公英、黄芩、桑叶、菊花、前胡、牛蒡子、泽泻、胖大海、蝉蜕、木蝴蝶共十一味加水煎煮二次,每次2小时,合并煎液,滤过,滤液浓缩至25℃时测得相对密度为1.28-1.30的清膏,加乙醇使含醇量达70%,搅拌均匀,静置,滤过,滤液与上述步骤二中的乙醇提取液合并,回收乙醇并浓缩至50℃时测得相对密度为1.05-1.10的清膏,加入适宜辅料,制粒,干燥,整粒,压片,即得含片。
本发明的有益效果是:本发明提供的一种治疗小儿急性扁桃体炎、急性咽炎的中药组合物及其制备方法,在治疗小儿急性扁桃体炎、急性咽炎方面疗效更好、配伍合理、协同发挥作用、功效明确、安全无任何毒副作用,长期服用安全性高,不会产生依赖性。
本发明方案是经过发明人多次反复试验,不断改进调整总结出来的,上述药物的组方为最佳组方,药理效果显著增强。
主要药效学实验证明:
本发明原料重量配比:“金银花125份、连翘125份、玄参125份、蒲公英125份、赤芍50份、黄芩75份、桑叶50份、菊花50份、前胡50份、苦杏仁50份、牛蒡子50份、泽泻50份、胖大海50份、浙贝母50份、蝉蜕50份、木蝴蝶50份。”同原发明重量配比1:“金银花115份、连翘115份、玄参115份、板蓝根115份、赤芍40份、黄芩65份、桑叶40份、菊花40份、前胡40份、苦杏仁40份、牛蒡子40份、泽泻40份、胖大海40份、僵蚕40份、蝉蜕40份、木蝴蝶40份。”及原发明重量配比2:“金银花135份、连翘135份、玄参135份、板蓝根135份、赤芍60份、黄芩85份、桑叶60份、菊花60份、前胡60份、苦杏仁60份、牛蒡子60份、泽泻60份、胖大海60份、僵蚕60份、蝉蜕60份、木蝴蝶60份。”及原发明重量配比3:“金银花125份、连翘125份、玄参125份、板蓝根125份、赤芍50份、黄芩75份、桑叶50份、菊花50份、前胡50份、苦杏仁50份、牛蒡子50份、泽泻50份、胖大海50份、僵蚕50份、蝉蜕50份、木蝴蝶50份。”及原发明重量配比4:“13%金银花、13%连翘、13%玄参、11%黄芩、5%桑叶、5%菊花、5%牛蒡子、5%蝉蜕、5%赤芍、5%苦杏仁、5%前胡、5%胖大海、5%木蝴蝶、5%泽泻。”及本发明筛选组:“金银花50份、连翘50份、玄参50份、蒲公英50份、赤芍125份、黄芩75份、桑叶125份、菊花125份、前胡125份、苦杏仁125份、牛蒡子125份、泽泻125份、胖大海125份、浙贝母125份、蝉蜕125份、木蝴蝶125份。”相比较,本发明原料重量配比的药效学试验结果有显著提高。
主要药效学试验
一、实验药物的制备:
1、原料:
本发明组:由金银花163g、连翘163g、玄参163g、蒲公英163g、赤芍65g、黄芩98g、桑叶65g、菊花65g、前胡65g、苦杏仁65g、牛蒡子65g、泽泻65g、胖大海65g、浙贝母65g、蝉蜕65g、木蝴蝶65g制备(按本发明重量配比:金银花125份、连翘125份、玄参125份、蒲公英125份、赤芍50份、黄芩75份、桑叶50份、菊花50份、前胡50份、苦杏仁50份、牛蒡子50份、泽泻50份、胖大海50份、浙贝母50份、蝉蜕50份、木蝴蝶50份配比)。
a组为原发明重量配比1组(公开号为“CN1544069A”的权利要求1的低点值配比):由金银花174.6g、连翘174.6g、玄参174.6g、板蓝根174.6g、赤芍60.7g、黄芩98.7g、桑叶60.7g、菊花60.7g、前胡60.7g、苦杏仁60.7g、牛蒡子60.7g、泽泻60.7g、胖大海60.7g、僵蚕60.7g、蝉蜕60.7g、木蝴蝶60.7g制备(按原发明重量配比1:金银花115份、连翘115份、玄参115份、板蓝根115份、赤芍40份、黄芩65份、桑叶40份、菊花40份、前胡40份、苦杏仁40份、牛蒡子40份、泽泻40份、胖大海40份、僵蚕40份、蝉蜕40份、木蝴蝶40份配比)。
b组为原发明重量配比2组:(公开号为“CN1544069A”的权利要求1的高点值配比)由金银花153.9g、连翘153.9g、玄参153.9g、板蓝根153.9g、赤芍68.4g、黄芩96.9g、桑叶68.4g、菊花68.4g、前胡68.4g、苦杏仁68.4g、牛蒡子68.4g、泽泻68.4g、胖大海68.4g、僵蚕68.4g、蝉蜕68.4g、木蝴蝶68.4g制备(按原发明重量配比2:“金银花135份、连翘135份、玄参135份、板蓝根135份、赤芍60份、黄芩85份、桑叶60份、菊花60份、前胡60份、苦杏仁60份、牛蒡子60份、泽泻60份、胖大海60份、僵蚕60份、蝉蜕60份、木蝴蝶60份”配比)。
c组为原发明重量配比3组:(公开号为“CN1544069A”的权利要求2的配比):由金银花163g、连翘163g、玄参163g、板蓝根163g、赤芍65g、黄芩98g、桑叶65g、菊花65g、前胡65g、苦杏仁65g、牛蒡子65g、泽泻65g、胖大海65g、僵蚕65g、蝉蜕65g、木蝴蝶65g制备(按原发明重量配比3:“金银花125份、连翘125份、玄参125份、板蓝根125份、赤芍50份、黄芩75份、桑叶50份、菊花50份、前胡50份、苦杏仁50份、牛蒡子50份、泽泻50份、胖大海50份、僵蚕50份、蝉蜕50份、木蝴蝶50份”配比)。
d组为原发明重量配比4组:(公开号为“CN102973746A”的权利要求1的配比)由金银花190.3g、连翘190.3g、玄参190.3g、黄芩161.1g、桑叶73.3g、菊花73.3g、牛蒡子73.3g、蝉蜕73.3g、赤芍73.3g、苦杏仁73.3g、前胡73.3g、胖大海73.3g、木蝴蝶73.3g、泽泻73.3g制备(按原发明重量配比4:“13%金银花、13%连翘、13%玄参、11%黄芩、5%桑叶、5%菊花、5%牛蒡子、5%蝉蜕、5%赤芍、5%苦杏仁、5%前胡、5%胖大海、5%木蝴蝶、5%泽泻”配比)。
e组为本发明处方筛选组配比:由金银花44.4g、连翘44.4g、玄参44.4g、蒲公英44.4g、赤芍111g、黄芩66.6g、桑叶111g、菊花111g、前胡111g、苦杏仁111g、牛蒡子111g、泽泻111g、胖大海111g、浙贝母111g、蝉蜕111g、木蝴蝶111g制备(按本发明处方筛选组重量配比:“金银花50份、连翘50份、玄参50份、蒲公英50份、赤芍125份、黄芩75份、桑叶125份、菊花125份、前胡125份、苦杏仁125份、牛蒡子125份、泽泻125份、胖大海125份、浙贝母125份、蝉蜕125份、木蝴蝶125份”配比)。
2.制备方法:
本发明组、a组、b组、c组、d组、e组的制法基本相同,本发明组和e组的处方用药材相同;a组、b组、c组的处方用药材相同;d组为缺少僵蚕及板蓝根组,具体制备方法如下:
本发明组和e组的制备方法为:按照本发明实施例1的制法制备,具体如下:
步骤一:将苦杏仁去皮后,备用;
步骤二:将金银花、连翘、赤芍、苦杏仁、浙贝母粉碎成40-60目粗粉,用80%乙醇加热回流提取二次,每次2小时,合并提取液,滤过,滤液备用;
步骤三:将步骤二中的药渣与其余玄参、蒲公英、黄芩、桑叶、菊花、前胡、牛蒡子、泽泻、胖大海、蝉蜕、木蝴蝶共十一味加水煎煮二次,每次2小时,合并煎液,滤过,滤液浓缩至25℃时测得相对密度为1.28-1.30的清膏,加乙醇使含醇量达70%,搅拌均匀,静置,滤过,滤液与上述步骤二中的乙醇提取液合并,回收乙醇并浓缩至50℃时测得相对密度为1.05-1.10的清膏,加入糖粉和糊精,制粒,干燥,整粒,即得颗粒剂。
a组、b组、c组的制备方法为:公开号“CN1544069A”实施例5的制备方法
步骤一:将僵蚕麸炒,苦杏仁去皮后,备用;
步骤二:将板蓝根、僵蚕粉碎成细粉,过100-120目筛,混合均匀后,备用;
步骤三:将金银花、连翘、赤芍、苦杏仁粉碎成40-60目粗粉,以80%乙醇加热回流提取二次,每次2小时,合并提取液,滤过,将滤液收集;
步骤四:将步骤三中的药渣与其余玄参、黄芩、桑叶、菊花、前胡、牛蒡子、泽泻、胖大海、蝉蜕、木蝴蝶共十味加水煎煮二次,每次2小时,合并煎液,滤过,滤液浓缩至在温度为50℃时、相对密度为1.18-1.20的清膏,加乙醇使含醇量达70%,搅拌均匀,静置,滤过,滤液与上述步骤三中的乙醇提取液合并,回收乙醇并浓缩在60℃时、相对密度为1.38-1.40的清膏,再加入步骤二制备的细粉;
步骤五:然后再加入400g蔗糖、200g淀粉,制粒,即得颗粒剂。
d组的制备方法为:
步骤一:取13%金银花、13%连翘、13%玄参、11%黄芩、5%桑叶、5%菊花、5%牛蒡子、5%蝉蜕、5%赤芍、5%苦杏仁、5%前胡、5%胖大海、5%木蝴蝶、5%泽泻混合粉碎成粗粉;
步骤二:将步骤一所得混合粗粉分别加10倍量、8倍量70%乙醇回流提取2次,每次2小时,合并提取液,滤过,滤液浓缩至温度为60℃时相对密度为1.10-1.15的清膏;
步骤三:将步骤二所得浸膏喷雾干燥,制成复方提取物。
二、:试验过程及试验结果实验目的:通过对本发明组和a.b.c.d.e组的抗炎、镇痛、解热、祛痰等作用的药理实验研究,将本发明组和a.b.c.d.e组进行对比,观察其药理作用的强弱。
试验方法:本发明组和a.b.c.d.e组对二甲苯致小鼠耳肿胀的影响;对小鼠毛细血管通透性的影响;对醋酸所致小鼠扭体次数的影响;对三联菌苗引起家兔发热的影响;对小鼠酚红分泌量的影响。
一、对二甲苯致小鼠耳肿胀的影响
实验材料
1、动物:昆明种小鼠,雌雄兼有,体重18~22g。
2、药物:本发明组和a、b、c、d、e组;药物在实验前用蒸馏水配置,灌胃给药。
实验方法昆明种小鼠70只,雌雄各半,体重18~22g,随机分成7组,每组10只。对照组灌胃同体积的生理盐水;本发明组和a、b、c、d、e组分别灌胃给药3.6g/kg;连续给药7d,每日1次,末次给药1h后将二甲苯0.05mL均匀涂于小鼠右耳,左耳不涂做对照,30min后剪下左右耳廓,以直径8毫米打孔器同时取下两耳片,电子天平称重,计算耳肿胀率。
耳肿胀率(%)=[(右耳质量-左耳质量)/左耳质量]×100%实验结果:见表1
分组 | 动物(只) | 剂量(g/kg) | 耳肿胀率 |
对照组 | 10 | — | 1.12±0.36 |
a组 | 10 | 3.6 | 0.71±0.25**△ |
b组 | 10 | 3.6 | 0.73±0.22**△ |
c组 | 10 | 3.6 | 0.72±0.24**△ |
d组 | 10 | 3.6 | 0.73±0.21**△ |
e组 | 10 | 3.6 | 0.69±0.23**△ |
本发明组 | 10 | 3.6 | 0.50±0.15** |
与对照组相比**P<0.01;与本发明组比△P<0.05。
结果表明:本发明组和a、b、c、d、e组均明显降低小鼠耳肿胀率,与对照组相比有极显著性差异(P<0.01);a、b、c、d、e组与本发明组相比较有显著性差异(P<0.05);e组作用优于a、b、c、d组,但无显著性差异。可见,本发明组比a、b、c、d、e组的抗炎作用强。
二、对小鼠毛细血管通透性的影响
实验材料
1、动物:昆明种小鼠,雌雄兼有,体重18~22g。
2、药物:本发明组和a、b、c、d、e组;药物在实验前用蒸馏水配置,灌胃给药。
实验方法
昆明种小鼠70只,雌雄各半,体重18~22g,随机分成7组,每组10只。对照组灌胃同体积的生理盐水;本发明组和a、b、c、d、e组分别灌胃给药3.6g/kg;连续给药7d,每日1次,末次给药1h后,各组小鼠尾静脉注射0.5%依文思蓝生理盐水溶液(0.01g/kg),随即腹腔注射0.6%冰醋酸,0.2mL/只,20min后脱颈椎处死,剪开腹部皮肤肌肉,用6mL生理盐水分数次洗涤腹腔,以吸管吸出洗涤液,合并后加入生理盐水至10mL,3000r/min离心15min,取上清液于分光光度计590nm处测定OD值。实验结果:见表2
分组 | 动物(只) | 剂量(g/kg) | OD值 |
对照组 | 10 | — | 0.072±0.021 |
a组 | 10 | 3.6 | 0.047±0.017**△ |
b组 | 10 | 3.6 | 0.046±0.018**△ |
c组 | 10 | 3.6 | 0.048±0.015**△ |
d组 | 10 | 3.6 | 0.047±0.016**△ |
e组 | 10 | 3.6 | 0.043±0.013**△ |
本发明组 | 10 | 3.6 | 0.025±0.023** |
与对照组相比**P<0.01;与本发明组比△P<0.05。
结果表明:本发明组和a、b、c、d、e组均明显降低OD值,明显抑制冰醋酸所致小鼠腹部毛细血管通透性亢进,与对照组相比有极显著性差异(P<0.01);a、b、c、d、e组与本发明组相比较有显著性差异(P<0.05);e组作用优于a、b、c、d组,但无显著性差异。可见,本发明组比a、b、c、d、e组的抗炎作用强。
三、对醋酸所致小鼠扭体次数的影响
实验材料
1、动物:昆明种小鼠,雌雄兼有,体重18~22g。
2、药物:本发明组和a、b、c、d、e组;药物在实验前用蒸馏水配置,灌胃给药。
实验方法
昆明种小鼠70只,雌雄各半,体重18~22g,随机分成7组,每组10只。对照组灌胃同体积的生理盐水;本发明组和a、b、c、d、e组分别灌胃给药3.6g/kg;连续给药7d,每日1次,于末次给药1h后腹腔注射0.6%醋酸溶液0.01mL/g,5min后,观察15min内各组小鼠扭体次数。实验结果:见表3
分组 | 动物(只) | 剂量(g/kg) | 扭体次数 |
对照组 | 10 | — | 32±8 |
a组 | 10 | 3.6 | 23±5**△ |
b组 | 10 | 3.6 | 22±7**△ |
c组 | 10 | 3.6 | 23±5**△ |
d组 | 10 | 3.6 | 22±6**△ |
e组 | 10 | 3.6 | 21±5**△ |
本发明组 | 10 | 3.6 | 14±9** |
与对照组相比**P<0.01;与本发明组比△P<0.05。
结果表明:本发明组和a、b、c、d、e组均明显减少小鼠的扭体次数,与对照组相比有极显著性差异(P<0.01);a、b、c、d、e组与本发明组相比较有显著性差异(P<0.05);e组作用优于a、b、c、d组,但无显著性差异。可见,本发明组比a、b、c、d、e组的镇痛作用强。
四、对三联菌苗引起家兔发热的影响
实验材料
1、动物:昆明种小鼠,雌雄兼有,体重18~22g。
2、药物:本发明组和a、b、c、d、e组;药物在实验前用蒸馏水配置,灌胃给药。
实验方法
昆明种小鼠70只,雌雄各半,体重18~22g,随机分成7组,每组10只。对照组灌胃同体积的蒸馏水;本发明组和a、b、c、d、e组分别灌胃给药0.9g/kg;连续给药3d,每日1次,给药量20ml/kg,末次药后1h静脉注射吸附百日咳菌苗、白喉、破伤风毒素混合制剂,记录致热后1.5、3.0、6.0h肛温变化。实验结果:见表4
与对照组相比**P<0.01;与本发明组比△P<0.05。
结果表明:本发明组和a、b、c、d、e组对家兔体温升高有明显的抑制作用,对家兔致炎后1.5h、3h、6h后升高的肛温明显降低,与对照组相比有极显著性差异(P<0.01);a、b、c、d、e组与本发明组相比较有显著性差异(P<0.05);e组作用优于a、b、c、d组,但无显著性差异。可见,本发明组比a、b、c、d、e组的解热作用强。
五、对小鼠酚红分泌量的影响
实验材料
1、动物:昆明种小鼠,雌雄兼有,体重18~22g。
2、药物:本发明组和a、b、c、d、e组;药物在实验前用蒸馏水配置,灌胃给药。
实验方法
昆明种小鼠70只,雌雄各半,体重18~22g,随机分成7组,每组10只。对照组灌胃同体积的生理盐水;本发明组和a、b、c、d、e组分别灌胃给药3.6g/kg;连续给药7d,每日1次。末次给药0.5h后,各组均腹腔注射10%酚红溶液0.2ml/10g,0.5h后,处死小鼠,仰位固定,分离气管;以注射器抽取5%NaHCO3液0.4ml,经气管注入肺内,抽洗3次,将抽洗液注入小试管。如此重复3次,将3次抽洗液合并,离心,备用。取离心后的红色澄明抽洗液0.5ml,加入1.5ml5%的NaHCO3液混匀,于紫外可见分光光度计546nm波长处测定吸光度值,从酚红标准曲线算出各吸光度值的相应浓度。实验结果:见表5
分组 | 动物(只) | 剂量(g/kg) | 酚红分泌量(μg/ml) |
对照组 | 10 | — | 1.834±0.357 |
a组 | 10 | 3.6 | 2.181±0.126**△ |
b组 | 10 | 3.6 | 2.188±0.147**△ |
c组 | 10 | 3.6 | 2.178±0.115**△ |
d组 | 10 | 3.6 | 2.180±0.121**△ |
e组 | 10 | 3.6 | 2.295±0.105**△ |
本发明组 | 10 | 3.6 | 2.668±0.538** |
与对照组相比**P<0.01;与本发明组比△P<0.05。
结果表明:本发明组和a、b、c、d、e组均明显促进小鼠酚红的分泌量,与对照组相比有极显著性差异(P<0.01);a、b、c、d、e组与本发明组相比较有显著性差异(P<0.05);e组作用优于a、b、c、d组,但无显著性差异。可见,本发明组比a、b、c、d、e组的祛痰作用强。
实验结果:本发明组和a.b.c.d.e组明显降低小鼠耳肿胀率;明显降低OD值,明显抑制冰醋酸所致小鼠腹部毛细血管通透性亢进;明显减少小鼠的扭体次数;家兔体温升高有明显的抑制作用;明显促进小鼠酚红的分泌量。
结论:本发明组比a.b.c.d.e组的抗炎、镇痛、解热、祛痰等药理作用强。因此,临床上本发明组比a.b.c.d.e组治疗小儿急性扁桃体炎、急性咽炎的作用强。
具体实施方式
下面结合具体实施例对本发明作进一步说明,但是不作为对本发明的限制。
实施例1:
本发明颗粒剂的制备:
处方:
制备方法:
步骤一:将苦杏仁去皮后,备用;
步骤二:将金银花、连翘、赤芍、苦杏仁、浙贝母粉碎成40-60目粗粉,用80%乙醇加热回流提取二次,每次2小时,合并提取液,滤过,滤液备用;
步骤三:将步骤二中的药渣与其余玄参、蒲公英、黄芩、桑叶、菊花、前胡、牛蒡子、泽泻、胖大海、蝉蜕、木蝴蝶共十一味加水煎煮二次,每次2小时,合并煎液,滤过,滤液浓缩至25℃时测得相对密度为1.28-1.30的清膏,加乙醇使含醇量达70%,搅拌均匀,静置,滤过,滤液与上述步骤二中的乙醇提取液合并,回收乙醇并浓缩至50℃时测得相对密度为1.05-1.10的清膏,加入糖粉和糊精,制粒,干燥,整粒,即得颗粒剂。
实施例2:
本发明颗粒剂的制备:
处方:
制备方法:
步骤一:将苦杏仁去皮后,备用;
步骤二:将金银花、连翘、赤芍、苦杏仁、浙贝母粉碎成40-60目粗粉,用80%乙醇加热回流提取二次,每次2小时,合并提取液,滤过,滤液备用;
步骤三:将步骤二中的药渣与其余玄参、蒲公英、黄芩、桑叶、菊花、前胡、牛蒡子、泽泻、胖大海、蝉蜕、木蝴蝶共十一味加水煎煮二次,每次2小时,合并煎液,滤过,滤液浓缩至25℃时测得相对密度为1.28-1.30的清膏,加乙醇使含醇量达70%,搅拌均匀,静置,滤过,滤液与上述步骤二中的乙醇提取液合并,回收乙醇并浓缩至50℃时测得相对密度为1.05-1.10的清膏,加入适宜辅料,制成口服液。
实施例3:
本发明含片的制备:
含片:
制备方法:
步骤一:将苦杏仁去皮后,备用;
步骤二:将金银花、连翘、赤芍、苦杏仁、浙贝母粉碎成40-60目粗粉,用80%乙醇加热回流提取二次,每次2小时,合并提取液,滤过,滤液备用;
步骤三:将步骤二中的药渣与其余玄参、蒲公英、黄芩、桑叶、菊花、前胡、牛蒡子、泽泻、胖大海、蝉蜕、木蝴蝶共十一味加水煎煮二次,每次2小时,合并煎液,滤过,滤液浓缩至25℃时测得相对密度为1.28-1.30的清膏,加乙醇使含醇量达70%,搅拌均匀,静置,滤过,滤液与上述步骤二中的乙醇提取液合并,回收乙醇并浓缩至50℃时测得相对密度为1.05-1.10的清膏,加入适宜辅料,制粒,干燥,整粒,压片,即得含片。
Claims (7)
1.一种治疗小儿急性扁桃体炎、急性咽炎的中药组合物,其特征在于,它是由以下重量配比的中药原料制成的药剂:
金银花105-145份、连翘105-145份、玄参105-145份、蒲公英105-145份、赤芍30-70份、黄芩55-95份、桑叶30-70份、菊花30-70份、前胡30-70份、苦杏仁30-70份、牛蒡子30-70份、泽泻30-70份、胖大海30-70份、浙贝母30-70份、蝉蜕30-70份、木蝴蝶30-70份。
2.根据权利要求1所述的一种治疗小儿急性扁桃体炎、急性咽炎的中药组合物,其特征在于,它是由以下重量配比的中药原料制成的药剂:
金银花125份、连翘125份、玄参125份、蒲公英125份、赤芍50份、黄芩75份、桑叶50份、菊花50份、前胡50份、苦杏仁50份、牛蒡子50份、泽泻50份、胖大海50份、浙贝母50份、蝉蜕50份、木蝴蝶50份。
3.根据权利要求1或2所述的一种治疗小儿急性扁桃体炎、急性咽炎的中药组合物,其特征在于,
所述的药剂是任何一种药剂学上所述的剂型。
4.根据权利要求3所述的一种治疗小儿急性扁桃体炎、急性咽炎的中药组合物,其特征在于,
所述的剂型为颗粒剂或口服液或含片。
5.根据权利要求4所述的一种治疗小儿急性扁桃体炎、急性咽炎的中药组合物,其特征在于,所述的剂型为颗粒剂的制备方法包括以下步骤:
步骤一:将苦杏仁去皮后,备用;
步骤二:将金银花、连翘、赤芍、苦杏仁、浙贝母粉碎成40-60目粗粉,用80%乙醇加热回流提取二次,每次2小时,合并提取液,滤过,滤液备用;
步骤三:将步骤二中的药渣与其余玄参、蒲公英、黄芩、桑叶、菊花、前胡、牛蒡子、泽泻、胖大海、蝉蜕、木蝴蝶共十一味加水煎煮二次,每次2小时,合并煎液,滤过,滤液浓缩至25℃时测得相对密度为1.28-1.30的清膏,加乙醇使含醇量达70%,搅拌均匀,静置,滤过,滤液与上述步骤二中的乙醇提取液合并,回收乙醇并浓缩至50℃时测得相对密度为1.05-1.10的清膏,加入糖粉和糊精,制粒,干燥,整粒,即得颗粒剂。
6.根据权利要求4所述的一种治疗小儿急性扁桃体炎、急性咽炎的中药组合物,其特征在于,所述的剂型为口服液的制备方法包括以下步骤:
步骤一:将苦杏仁去皮后,备用;
步骤二:将金银花、连翘、赤芍、苦杏仁、浙贝母粉碎成40-60目粗粉,用80%乙醇加热回流提取二次,每次2小时,合并提取液,滤过,滤液备用;
步骤三:将步骤二中的药渣与其余玄参、蒲公英、黄芩、桑叶、菊花、前胡、牛蒡子、泽泻、胖大海、蝉蜕、木蝴蝶共十一味加水煎煮二次,每次2小时,合并煎液,滤过,滤液浓缩至25℃时测得相对密度为1.28-1.30的清膏,加乙醇使含醇量达70%,搅拌均匀,静置,滤过,滤液与上述步骤二中的乙醇提取液合并,回收乙醇并浓缩至50℃时测得相对密度为1.05-1.10的清膏,加入适宜辅料,制成口服液。
7.根据权利要求4所述的一种治疗小儿急性扁桃体炎、急性咽炎的中药组合物,其特征在于,所述的剂型为含片的制备方法包括以下步骤:
步骤一:将苦杏仁去皮后,备用;
步骤二:将金银花、连翘、赤芍、苦杏仁、浙贝母粉碎成40-60目粗粉,用80%乙醇加热回流提取二次,每次2小时,合并提取液,滤过,滤液备用;
步骤三:将步骤二中的药渣与其余玄参、蒲公英、黄芩、桑叶、菊花、前胡、牛蒡子、泽泻、胖大海、蝉蜕、木蝴蝶共十一味加水煎煮二次,每次2小时,合并煎液,滤过,滤液浓缩至25℃时测得相对密度为1.28-1.30的清膏,加乙醇使含醇量达70%,搅拌均匀,静置,滤过,滤液与上述步骤二中的乙醇提取液合并,回收乙醇并浓缩至50℃时测得相对密度为1.05-1.10的清膏,加入适宜辅料,制粒,干燥,整粒,压片,即得含片。
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