CN105832880A - 一种治疗中耳炎的中药复方滴剂 - Google Patents
一种治疗中耳炎的中药复方滴剂 Download PDFInfo
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Abstract
本发明公开了一种治疗中耳炎的中药复方滴剂,其由以下重量份的原料制得:黄腐酸或黄腐酸钠10‑15份、鱼腥草5‑10份、黄藤6‑8份、金荞麦3‑5份、岗梅根2‑4份、金果榄4‑6份、通光散3‑5份、冰糖草5‑8份;本发明治疗中耳炎的中药复方滴剂具有疗效快,无副作用,不易复发等特点,可以有效治愈中耳炎引起的并发症如发热,呕吐,腹泻,咳嗽等;本发明组方合理,具有清热解毒,杀菌消炎,消肿疗疮,提高机体免疫力的功效,药源广,成本低,治疗中耳炎效果显著。
Description
技术领域
本发明属于中药技术领域,具体涉及一种治疗中耳炎的中药复方滴剂。
背景技术
累及中耳(包括咽鼓管、鼓室、鼓窦及乳突气房)全部或部分结构的炎性病变称之为中耳炎,好发于儿童。主要包括非化脓性及化脓性两大类。非化脓性者分为分泌性中耳炎、气压损伤性中耳炎等,化脓性者则主要分为急性和慢性。
引起中耳炎的病因较多,如感冒,不正确的擤鼻涕方式,游泳时水通过鼻咽部进入中耳,吸二手烟,长时间用耳机听摇滚类的大分贝音乐等。
中医认为,耳部疾病是由于致病邪毒侵犯,使机体正常生理功能失调,从而发生病理变化,具体到中耳炎,即为肝胆湿热、邪气盛行所致。
目前治疗中耳炎的方式主要采用药物治疗,如0.25%氯霉素液、氯霉素可的松液、氧氟沙星滴耳液等。治疗中耳炎的中药则主要有中耳炎散,吹耳散等。
李时珍在《本草纲目》中记载“乌金散”具有治疗炎症的作用,而“乌金散”就是现代所说的腐殖酸,黄腐酸是腐殖酸中的水溶性部分,由于分子量小、酸性基团多、溶解好,属于腐殖酸中医疗效果较好的一种。
鱼腥草(Houttuynia cordata Thunb.),性寒凉,归肺经,具有清热解毒,消肿疗疮、利尿除湿的功效;黄藤(Daemonorops margaritae (Hance) Becc.)具有清热解毒,利湿的作用,可有效治疗各类炎症;金荞麦(Fagopyrum dibotrys)具有祛痰、解热、抗炎、抗肿瘤等作用;岗梅根(Radix Ilicis Asprellae)主治感冒,高热烦渴,腹泻以及各种类型炎症等;金果榄(Radix Tinosporae),性味苦寒,有清热解毒,利咽,止痛之功效;通光散(Marsdenia tenacissima (Roxb.)Wight et Arn.)具有消炎,止咳,平喘的功效;冰糖草(Saccharum sinensis Roxb.)清热利湿,调中益肺,治感冒发热,肠炎腹泻等。
将以上几种中草药进行合理的配伍制成的中药复方滴剂可用于治疗中耳炎,且具有疗效快,成本低,给药方便等优点。以黄腐酸或黄腐酸钠为主药,配以鱼腥草、黄藤、金荞麦、岗梅根、金果榄、通光散、冰糖草为辅药制成的用于治疗中耳炎的中药复方滴剂未见文献报道。
发明内容
本发明的目的是提供一种治疗中耳炎的中药复方滴剂,其由以下重量份的原料制得:黄腐酸或黄腐酸钠10-15份、鱼腥草5-10份、黄藤6-8份、金荞麦3-5份、岗梅根2-4份、金果榄4-6份、通光散3-5份、冰糖草5-8份。
在本发明所述的治疗中耳炎的中药复方滴剂中,还可以加入一种或多种药物上可接受的辅料,以便于使用或提高吸收性能;辅料包括常规制备滴剂所用的防腐剂、助溶剂、稳定剂等。
所述防腐剂为对羟基苯甲酸乙酯、苯甲醇、苯乙醇中的一种。
所述助溶剂为苯甲酸钠、水杨酸钠、对氨基苯甲酸中的一种。
所述稳定剂为季戊四醇、木糖醇、甘露醇中的一种。
本发明方法中的黄腐酸为药用级黄腐酸或黄腐酸钠参照专利申请200810233669“褐煤氧化降解生产腐殖酸及其盐的方法”中方法制得(用无污染的过氧化氢作为氧化剂,并经过纯化,制得黄腐酸),市购的精制黄腐酸经重金属检测不超标后,也可以使用。
本发明治疗中耳炎的中药复方滴剂的制备方法,包括如下步骤:
(1)将鱼腥草、黄藤、金荞麦、岗梅根、金果榄、通光散、冰糖草洗净置于圆底烧瓶中,加入混合物质量6-8倍的纯化水,浸泡3-5小时,回流提取3次,每次30-60分钟,合并3次提取液,浓缩,得浸膏;
(2)将步骤(1)中浸膏真空干燥,粉碎,得细粉,然后加入黄腐酸或黄腐酸钠得混合药粉;
(3)向上述混合药粉中加入其质量3-5倍纯化水(同时加入常规滴剂辅料,例如质量百分比0.1-0.5%的防腐剂、0.05-0.1%的助溶剂、0.1-0.5%的稳定剂),搅拌使之混合均匀,加压灭菌15-30分钟,经超滤膜过滤,最后注入滴剂瓶中封口密封即得治疗中耳炎的中药复方滴剂。
所述中药复方滴剂的使用方法为:外耳道口向上,牵拉耳郭,将外耳道拉直,使药液沿外耳道缓缓流入耳内,每次3-5滴,每日滴3次。
与现有技术相比,本发明的优点如下:
本发明采用具有较强杀菌抗炎作用的黄腐酸或黄腐酸钠,加入鱼腥草、黄藤、金荞麦、岗梅根、金果榄、通光散、冰糖草制成的中药复方滴剂,可以有效治疗中耳炎且疗效快,效果显著,成本低,用药方便,经济实用。
具体实施方式
以下结合实施例对本发明作进一步详细说明,但本发明并不局限于这些实施例。
实施例1:本治疗中耳炎的中药复方滴剂,由以下中药原料制备而成:黄腐酸钠10g、鱼腥草5 g、黄藤6 g、金荞麦3g、岗梅根2 g、金果榄4 g、通光散3 g、冰糖草5 g。
上述治疗中耳炎的中药复方滴剂的制备方法,包括如下步骤:
(1)将鱼腥草、黄藤、金荞麦、岗梅根、金果榄、通光散、冰糖草洗净置于圆底烧瓶中,加入混合物质量6倍的纯化水,浸泡3小时,回流提取3次,每次30分钟,合并3次提取液,浓缩,得浸膏;
(2)将步骤(1)中浸膏真空干燥,粉碎,得细粉,然后加入黄腐酸钠得混合药粉;
(3)向上述混合药粉中加入其质量3倍的纯化水,然后加入0.1%对羟基苯甲酸乙酯、0.05%水杨酸钠、0.1%季戊四醇,加压灭菌15分钟,经超滤膜过滤,最后注入滴剂瓶中封口密封即得治疗中耳炎的中药复方滴剂。
本实施例制备得到的滴剂对金黄色葡萄球菌致豚鼠急性化脓性中耳炎的影响实验如下:
取36只健康正常的豚鼠,体重300-400g, 豚鼠左耳作为实验耳,经乙醚麻醉后,使用75%酒精消毒外耳道,向鼓室内注射金黄色葡萄球菌0.2mL(含菌量约为103CFU/L),感染24h后,观察造模是否成功,造模成功的评价标准:显微镜下观察豚鼠耳腔内有脓液,鼓膜明显充血、红肿;将36只动物随机分为3组,每组12只,第一组为生理盐水组,第二组为氯霉素滴耳液组,第三组为本实施例中药复方滴剂。在造模24后,三组豚鼠左耳分别给予生理盐水、氯霉素滴耳液、本实施例中药复方滴剂0.2mL,每天1次,每次2滴,连续给药7天后处死动物,观察各组炎症恢复情况,结果见表1;
表1:各组炎症恢复情况和实验后分泌物中菌落数(X±s,n=12)
;
本实施例和生理盐水组,氯霉素滴耳液组比较,P<0.05
典型病例
陈某,女,23岁,昆明某高校学生。患者就诊前感冒,耳内疼痛难忍,偶尔伴有耳鸣,头痛,鼓膜内有黄色液体,经诊断为急性化脓性中耳炎,使用消炎药治疗无果,使用本实施例中药复方滴剂,连用5天后,各种症状消失。
实施例2:本治疗中耳炎的中药复方滴剂,由以下中药原料制备而成:黄腐酸钠12g、鱼腥草8 g、黄藤7 g、金荞麦4 g、岗梅根3 g、金果榄5 g、通光散4 g、冰糖草6 g。
上述治疗中耳炎的中药复方滴剂的制备方法,包括如下步骤:
(1)将鱼腥草、黄藤、金荞麦、岗梅根、金果榄、通光散、冰糖草洗净置于圆底烧瓶中,加入7倍量的纯化水,浸泡4小时,回流提取3次,每次45分钟,合并3次提取液,浓缩,得浸膏;
(2)将步骤(1)中浸膏真空干燥,粉碎,得细粉,然后加入黄腐酸钠得混合药粉;
(3)向上述混合药粉中加入其质量4倍的纯化水,然后加入0.3%苯乙醇,0.08%对氨基苯甲酸、0.3%木糖醇,搅拌使之混合均匀,加压灭菌20分钟,经超滤膜过滤,最后注入滴剂瓶中封口密封即得治疗中耳炎的中药复方滴剂。
本实施例制备得到的滴剂对金黄色葡萄球菌致豚鼠急性化脓性中耳炎的影响实验同实施例1,结果见表2;
表2:各组炎症恢复情况和实验后分泌物中菌落数(X±s,n=12)
;
本实施例和生理盐水组,氯霉素滴耳液组比较,P<0.05;
典型病例
王某,男,45岁,昆明某事业单位职工。患化脓性中耳炎1年,使用本实施例中药复方滴剂一周后,化脓状况,听力得到明显改善,继续使用一周后,不适症状完全消失。
实施例3:本治疗中耳炎的中药复方滴剂,由以下中药原料制备而成:黄腐酸15 g、鱼腥草10 g、黄藤8 g、金荞麦5 g、岗梅根4 g、金果榄6 g、通光散5 g、冰糖草8 g。
上述治疗中耳炎的中药复方滴剂的制备方法,包括如下步骤:
(1)将鱼腥草、黄藤、金荞麦、岗梅根、金果榄、通光散、冰糖草洗净置于圆底烧瓶中,加入8倍量的纯化水,浸泡5小时,回流提取3次,每次60分钟,合并3次提取液,浓缩,得浸膏;
(2)将步骤(1)中浸膏真空干燥,粉碎,得细粉,然后加入黄腐酸得混合药粉;
(3)向上述混合药粉中加入5倍纯化水,然后加入0.5%苯甲醇、0.1%苯甲酸钠、0.5%甘露醇,搅拌使之混合均匀,加压灭菌30分钟,经超滤膜过滤,最后注入滴剂瓶中封口密封即得治疗中耳炎的中药复方滴剂。
本实施例制备得到的滴剂对金黄色葡萄球菌致豚鼠急性化脓性中耳炎的影响实验同实施例1,结果见表3;
表3:各组炎症恢复情况和实验后分泌物中菌落数(X±s,n=12)
本实施例和生理盐水组,氯霉素滴耳液组比较,P<0.05;
典型病例
李某,男,32岁,昆明某高校教师。患者因感冒上火导致两耳出现闷塞感,同时伴有头痛,咽痛,鼻塞等症状。使用本实施中药复方滴剂3天,各种症状有明显改善,继续使用2天后,各种不适症状完全消失。
实施例4:本治疗中耳炎的中药复方滴剂,由以下中药原料制备而成:黄腐酸12g、鱼腥草7g、黄藤6g、金荞麦4g、岗梅根2 g、金果榄5 g、通光散4g、冰糖草6 g。
上述治疗中耳炎的中药复方滴剂的制备方法,包括如下步骤:
(1)将鱼腥草、黄藤、金荞麦、岗梅根、金果榄、通光散、冰糖草洗净置于圆底烧瓶中,加入6倍量的纯化水,浸泡5小时,回流提取3次,每次45分钟,合并3次提取液,浓缩,得浸膏;
(2)将步骤(1)中浸膏真空干燥,粉碎,得细粉,然后加入黄腐酸得混合药粉;
(3)向上述混合药粉中加入3倍纯化水,然后加入0.2%对羟基苯甲酸乙酯、0.06%苯甲酸钠、0.3%木糖醇,搅拌使之混合均匀,加压灭菌20分钟,经超滤膜过滤,最后注入滴剂瓶中封口密封即得治疗中耳炎的中药复方滴剂。
本实施例制备得到的滴剂对金黄色葡萄球菌致豚鼠急性化脓性中耳炎的影响实验同实施例1,结果见表4;
表4:各组炎症恢复情况和实验后分泌物中菌落数(X±s,n=12)
本实施例和生理盐水组,氯霉素滴耳液组比较,P<0.05;
典型病例
杨某,女,35岁,昆明某公司员工,患化脓性中耳炎2年,听力减退,多次治疗均无果,使用本实施例中药复方滴剂一周后,化脓状况得到明显改善,继续使用5天后完全治愈且无复发。
实施例5:本治疗中耳炎的中药复方滴剂,由以下中药原料制备而成:黄腐酸14g、鱼腥草8g、黄藤7g、金荞麦3 g、岗梅根4 g、金果榄6 g、通光散5 g、冰糖草7g。
上述治疗中耳炎的中药复方滴剂的制备方法,包括如下步骤:
(1)将鱼腥草、黄藤、金荞麦、岗梅根、金果榄、通光散、冰糖草洗净置于圆底烧瓶中,加入7倍量的纯化水,浸泡4小时,回流提取3次,每次50分钟,合并3次提取液,浓缩,得浸膏;
(2)将步骤(1)中浸膏真空干燥,粉碎,得细粉,然后加入黄腐酸得混合药粉;
(3)向上述混合药粉中加入4倍纯化水,然后加入0.3%苯甲醇、0.08%苯甲酸钠、0.5%季戊四醇,搅拌使之混合均匀,加压灭菌25分钟,经超滤膜过滤,最后注入滴剂瓶中封口密封即得治疗中耳炎的中药复方滴剂。
本实施例制备得到的滴剂对金黄色葡萄球菌致豚鼠急性化脓性中耳炎的影响实验同实施例1,结果见表5;
表5:各组炎症恢复情况和实验后分泌物中菌落数(X±s,n=12)
本实施例和生理盐水组,氯霉素滴耳液组比较,P<0.05;
典型病例
孙某,男,50岁,昆明市西山区居民,患非化脓性中耳炎1年,使用各种药物治疗短期有效果,但不久又复发。使用本实施例中药复方滴剂10天后,完全治愈且无复发。
下面通过在临床上的使用说明本发明中药复方滴剂的临床疗效:临床病例180例,其中男107名,女73名,使用本发明药物,172例有效,总有效率达95.6%,149例治愈,治愈率82.8%。
综上所述,本发明治疗中耳炎具有疗效快,疗程短,治愈率高的特点,且成本低,制作简单,给药方便。本发明属于中药制剂,安全,无毒副作用,是一种治疗中耳炎较为理想的药物。
Claims (1)
1.一种治疗中耳炎的中药复方滴剂,其特征在于由以下重量份的原料制得:黄腐酸或黄腐酸钠10-15份、鱼腥草5-10份、黄藤6-8份、金荞麦3-5份、岗梅根2-4份、金果榄4-6份、通光散3-5份、冰糖草5-8份。
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