CN105311602B - 一种防治小儿哮喘的中药组合物 - Google Patents
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Abstract
本发明公开了一种防治小儿哮喘的中药组合物,是由以下重量的原料组成的:人参6g,白术6g,干姜3g,炙甘草6g,五味子6g,防风9g,细辛2g,麻黄6g,陈皮6g,茯苓6g。本发明还公开了该中药组合物的制备方法。本发明的防治小儿哮喘的中药组合物通过多种药物的协同作用起到温肺化痰,敛肺止咳,袪痰与健脾利湿配伍,祛邪不忘扶正,扶正祛邪共用,有培土生金之意,可以从根本上解决小儿哮喘的发病原因,对小儿哮喘具有优异的治疗效果,治愈率高,无毒副作用,不复发,便于推广,适合小儿使用。
Description
技术领域
本发明涉及中药技术领域,尤其涉及一种防治小儿哮喘的中药组合物。
技术背景
小儿哮喘,是指过敏体质者的支气管对某些外来物质产生高度敏感反应,使支气管痉挛、支气管粘膜水肿充血,支气管内分泌增多,从而引起咳嗽、气喘、多痰等一系列临床症状。小儿哮喘起病或急或缓,婴幼儿哮喘发病前往往有1-2天的上呼吸道感染症状,包括鼻痒、喷嚏、流清涕、揉眼睛、揉鼻子等表现,并可有明显的咳嗽、喘息。年长儿起病往往较突然,常以一阵阵咳嗽为开始,继而出现喘息、呼吸困难等。
小儿因生理病理有别于成人,在哮喘发病机制方面有其自身的特殊性。由于外感湿热之邪,或饮食不节,过食膏粱厚味,脾失健运,湿热内生,故部分患儿病情迁延,除表现咳喘、痰壅外,常伴有腹胀、腹痛,倦怠乏力,不欲饮食,或渴不多饮,大便秘结或黏滞不爽,舌质红,苔厚腻,脉象滑数,辨证属于湿热证候。现代医家对于湿热哮喘开始认识和重视,对其理论研究及临床应用在进一步中研究中。现代医学防治小儿哮喘作用局限,大都存在疗效不明显、治疗时间长、毒副作用大等不足。
发明内容
本发明针对现有技术的不足,提供了一种防治小儿哮喘的中药组合物,该中药组合物疗效显著、治愈率高、无毒副作用、不复发的特点。
本发明的目的是通过如下技术方案实现的:
一种防治小儿哮喘的中药组合物,是由以下重量的原料组成的:人参6g,白术6g,干姜3g,炙甘草6g,五味子6g,防风9g,细辛2g,麻黄6g,陈皮6g,茯苓6g。
所述的,中药组合物的剂型为合剂、口服液、颗粒剂和散剂。
优选的,中药组合物的剂型为口服液。
一种防治小儿哮喘的中药组合物的制备方法,是由以下步骤制备得到的:
1)按重量称取:人参600g,白术600g,干姜300g,炙甘草600g,五味子600g,防风900g,细辛200g,麻黄600g,陈皮600g,茯苓600g;
2)将上述原料药置于中药提取器内,加纯净水50L,浸渍2h,加热煎煮1.5h,过滤,得第一滤液;
3)向药渣中加水250L,加热煎煮1h,过滤,得第二滤液;
4)将第一滤液和第二滤液合并,静置12h,取上清液浓缩至2000mL,装量每瓶10mL,封口,116℃×40min灭菌,贴标签,即可制得防治哮喘的中药组合物。
治疗方法:一天两次,每次一瓶(10mL),低于三岁儿童减半,10天为一疗程。
各原料药的药理如下:
人参:味甘、微苦,性微温,归脾、肺、心、肾经,气雄体润,升多于降;具有补气固脱,健脾益肺,宁心益智,养血生津的功效。主治大病、久病、失血、脱液所致元气欲脱,神疲脉微;脾气不足之食少倦怠,呕吐泄泻;肺气虚弱之气短喘促,咳嗽无力;心气虚衰之失眠多梦,惊悸健忘,体虚多汗;津亏之口渴,消渴;血虚之萎黄,眩晕;肾虚阳萎,尿频,气虚外感。
白术:味苦、甘,性温。归脾、胃经。补脾益气、燥湿利水,其作用为:健胃助消化,对止呕止泻有一定作用,但常需配消导药或利水渗湿药;利尿作用较明显而持久,可能是由于抵制肾小管重吸收机能,增加钠的排泄;所含挥发油小量有镇静作用。此外,临床观察白术还有止汗、滋补等作用。
干姜:味辛,性热。归脾、胃、肺经。温中散寒即促进血液循环,服后胃肠有温暖感;健胃止呕;通过交感神经兴奋,使血压上升。功能为祛寒温中,回阳。主要用于吐泻腹痛,肢冷脉微,寒饮咳嗽,胃脘冷痛,寒湿痹痛等症。
炙甘草:味甘,性平。归心、肺、脾、胃经。补中益气:用于气虚倦怠乏力,心悸等,能补多种气虚证;清热解毒:用于痈疽疮疡,咽喉肿痛,热毒证等;祛痰止咳:用于多种气喘咳嗽,有祛痰止咳之功。调和药性:有缓和药性的作用。对多种致病毒素有解毒作用,并能增强肝脏的解毒功能,有抗炎和抗变态反应作用,有祛痰、镇咳作用,可缓解胃及肠管痉挛,有降血清转氨酶作用,有肾上腺皮质激素样作用,有强心作用,和抗癌作用。
五味子:性微温、味微甘、气香。敛肺,滋肾,生津,收汗,涩精。治肺虚喘咳,口干作渴,自汗,盗汗,劳伤羸瘦,梦遗滑精,久泻久痢。
防风:味辛、甘,性微温。归膀胱、肝、脾经。祛风解表,胜湿止痛,止痉定搐。用于感冒头痛,风湿痹痛,风疹瘙痒,破伤风。药理研究表明,防风含挥发油、甘露醇、苦味甙等。有解热、镇痛、镇静及抗惊厥、抗炎、抗病原微生物等作用。对血管、神经性头痛及腰背关节痛有一定疗效。
细辛:归肺、肾、心、肝、胆、脾经。散风祛寒,通窍止痛,下气祛痰。主治风寒感冒、鼻塞头痛、风寒湿痹、气逆痰多喘咳,牙痛。临床应用:用于治疗痰饮咳嗽(如慢性支气管炎、支气管扩张等有大量清晰痰液的咳嗽);用于治疗外感风寒,尤其鼻塞多涕,咽部有涎(分泌物多)者用之更为合适;用于治疗由风湿或流感引起的头痛、关节痛。
麻黄:味辛、微苦,性温。归肺、膀胱经。发汗、平喘、利尿。生用发汗力强,蜜制多用于平喘息止咳。主治风寒感冒,气喘咳嗽,水肿。适用于感冒风寒表证无汗者。临床主要用于平喘和治疗外感风寒。
陈皮:性温,味辛、苦。归脾经、胃经、肺经。用于脾胃气滞证。本品辛行温通,有行气止痛、健脾和中之功。又因味苦燥湿,故寒湿阻中的脾胃气滞,脘腹胀痛、恶心呕吐、泄泻者,用之尤为适宜,常与苍术、厚朴等同用,如平胃散。治脾虚气滞,腹痛喜按、不思饮食、食后腹胀、便溏舌淡者,可与党参、白术、茯苓等同用,如异功散。若脾胃气滞较甚,脘腹胀痛较剧者,每与木香、枳实等同用,以增强行气止痛之功。亦用于湿痰,寒痰咳嗽。既能燥湿化痰,又能温化寒痰,且辛行苦泄,而能宣肺止咳,为治痰之要药。治湿痰咳嗽,多与半夏、茯苓等同用。治寒痰咳嗽,多与干姜、细羊、五味子等同用。
茯苓:味甘、淡,性平。归心、肺、脾经。具有利尿、滋养、镇静功效。临床用于治疗水肿、小便不利,取其有利尿作用;用于治疗痰饮。前人的经验是“痰饮必用茯苓”,取其有利尿和补益脾胃作用;用于健脾化湿,治疗脾胃虚弱引起的消化不良,上腹胀满,食欲减少,以及脾虚泄泻等;用于镇静安神。
中医认为,婴幼儿喘息为本虚标实:素有体虚,内有痰湿,因外有风寒,引动伏痰,肺失宣肃,发为喘息。故治以解表散寒化饮,健脾益气扶正。
方中麻黄辛温,发汗解表,宣肺平喘,利尿行水,既解表邪,又兼顾痰饮之患。为君。细辛散寒祛风;止痛;温肺化饮;干姜温脾阳,助水湿运化,温阳化饮;陈皮健脾燥湿,理气化痰,三药合而为臣。然素有痰饮,大量辛温发散,恐耗伤肺气,故佐以五味子和防风,祛风解表,敛肺止咳,与辛散之品相配,一散一收,既可增强止咳平喘之功,又可制约辛散太过之性。痰之所生因脾虚脾失健运所致,人参、白术补脾益肺,为补肺要药。炙甘草健脾益气和中,祛痰止咳。茯苓健脾利湿,与人参、白术、炙甘草相伍,为四君子汤组方,健脾益气,祛湿化痰,杜绝生痰之源。以上俱为佐药。炙甘草调和药性,兼为使药。
本发明的有益效果:本发明的防治小儿哮喘的中药组合物通过多种药物的协同作用起到温肺化痰,敛肺止咳,袪痰与健脾利湿配伍,祛邪不忘扶正,扶正祛邪共用,有培土生金之意,可以从根本上解决小儿哮喘的发病原因,对小儿哮喘具有优异的治疗效果,治愈率高,无毒副作用,不复发,便于推广,适合小儿使用。
具体实施方式
实施例1
一种防治小儿哮喘的中药组合物,是由以下重量的原料组成的:人参6g,白术6g,干姜3g,炙甘草6g,五味子6g,防风9g,细辛2g,麻黄6g,陈皮6g,茯苓6g。
所述的,中药组合物的剂型为合剂、口服液、颗粒剂和散剂。
优选的,中药组合物的剂型为口服液。
一种防治小儿哮喘的中药组合物的口服液剂型的制备方法,是由以下步骤制备得到的:
1)按重量称取:人参600g,白术600g,干姜300g,炙甘草600g,五味子600g,防风900g,细辛200g,麻黄600g,陈皮600g,茯苓600g;
2)将上述原料药置于中药提取器内,加纯净水50L,浸渍2h,加热煎煮1.5h,过滤,得第一滤液;
3)向药渣中加水250L,加热煎煮1h,过滤,得第二滤液;
4)将第一滤液和第二滤液合并,静置12h,取上清液浓缩至2000mL,装量每瓶10mL,封口,116℃×40min灭菌,贴标签,即可制得防治哮喘的中药组合物。
治疗方法:一天两次,每次一瓶(10mL),低于三岁儿童减半,10天为一疗程。
急性毒性试验
选用昆明种小白鼠50只,雌雄各半,体重为18-24g,随机分为5组,每组10只,服用本发明制备的口服液,采用口服灌胃法进行给药,5组给药的药量分别相当于原药材为30g/kg、25g/kg、15g/kg、5g/kg及生理盐水对照组,每组重复实验两次,观察给药后1周内动物死亡情况,结果动物无一死亡,进食、行为活动、体重正常;肉眼部检心、肝、脾、肺、肾等重要脏器,结果均无异常改变,进行解剖并作各脏器组织学检查,均未见异常病理学改变,未见对小鼠产生急性毒性反应。
临床试验
一般资料:选择90例经中、西医诊断为哮喘的患儿为研究对象,其中男46例,女44例,年龄2-13岁,平均年龄6.9岁。采用随机数字表法将其均分为治疗组与对照组各45例。实验组中病程3-30天,平均病程(13.5±2.8)天;对照组中病程2-27天,平均病程(12.3±1.7)天。两组患儿的病程、性别、年龄等一般资料比较差异无统计学意义(P>0.05),具有可比性。
治疗方法:治疗组患儿口服本发明制备的口服液,一天两次,每次一瓶(10mL),低于三岁儿童减半。
对照组患儿雾化吸入万托林和普米克治疗,每日2次,每次200-200μg,若患儿出现细菌感染,可酌情给予一定量抗生素治疗。
两组患者均以10天为一疗程,治疗周期为2个疗程。
疗效判定标准
参照《中医病证诊断疗效标准》中的小儿哮喘疗效评定标准。
显效:患儿呼吸状况由重度转为中度或由中度转为轻度,肺哮鸣音消失;
有效:呼吸状况好转,肺哮鸣音减轻;
无效:患儿病情无改善甚至加重。
总有效=显效+有效。
治疗结果
所有数据均采用spss17.0软件进行统计分析,计量资料采用均数加减标准差表示,组间比较采用独立样本t检验;计数资料采用率(%)表示,进行x2检验。P<0.05为差异具有统计学意义。
两组患儿经过治疗,治疗结果如表1所示。治疗组患儿总有效率为95.6%,显著高于对照组的57.8%,组间临床疗效比较差异具有统计学意义(P<0.05)。
表1 治疗结果
组别 | 例数 | 显效(%) | 有效(%) | 无效(%) | 总有效率 |
治疗组 | 45 | 18(40%) | 25(55.6%) | 2(4.4%) | 95.6% |
对照组 | 45 | 9(20%) | 17(37.8%) | 19(42.2%) | 57.8% |
两组患儿在治疗时绝大多数表现出很好的效果,且起效快,治疗效果显著。在上述治疗基础上继续服用本发明的中药组合物5个月,除无效患者,其他全部痊愈,随访2年无复发者。且在服用药物期间,无不良反应产生。
典型病例
病例1:赵某,女,3.5岁。就诊时咳嗽痰多,喘息不甚,咳甚呕吐,口中异味,小便黄,流清鼻涕,经诊断为小儿哮喘。服用本发明的中药组合物1个疗程,各项症状减轻,继续服用2个疗程,症状消失,随访2年无复发。
Claims (4)
1.一种防治小儿哮喘的中药组合物,其特征在于,是由以下重量的原料组成的:人参6g,白术6g,干姜3g,炙甘草6g,五味子6g,防风9g,细辛2g,麻黄6g,陈皮6g,茯苓6g。
2.根据权利要求1所述的中药组合物,其特征在于,所述中药组合物的剂型为合剂、口服液、颗粒剂和散剂。
3.根据权利要求2所述的中药组合物,其特征在于,所述中药组合物的剂型为口服液。
4.一种防治小儿哮喘的中药组合物的制备方法,其特征在于,是由以下步骤制备得到的:
1) 按重量称取:人参600g,白术600g,干姜300g,炙甘草600g,五味子600g,防风900g,细辛200g,麻黄600g,陈皮600g,茯苓600g;
2)将上述原料药置于中药提取器内,加纯净水50L,浸渍2h,加热煎煮1.5h,过滤,得第一滤液;
3)向药渣中加水250L,加热煎煮1h,过滤,得第二滤液;
4)将第一滤液和第二滤液合并,静置12h,取上清液浓缩至2000mL,装量每瓶10mL,封口,116℃×40min灭菌,贴标签,即可制得防治哮喘的中药组合物。
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