CN117919351A - 一种治疗小儿夜间咳嗽的药物组合物及其制剂和应用 - Google Patents
一种治疗小儿夜间咳嗽的药物组合物及其制剂和应用 Download PDFInfo
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Abstract
本发明公开一种治疗小儿夜间咳嗽的药物组合物,由柴胡、白芍、枳实、炒谷芽、炒麦芽、陈皮、法夏、蜜紫菀、白前、前胡、天花粉、麦冬、淡豆豉、炙甘草组成。所述药物组合物可添加药学上可接受的辅料,制成制剂。所述药物组合物及其制剂可用于制备治疗小儿夜间咳嗽的药物。
Description
技术领域
本发明属于药物领域,具体涉及一种治疗小儿夜间咳嗽的药物组合物及其制剂和应用。
背景技术
咳嗽是临床常见的多发、高发疾病,尤其在冬春季节及寒温不调之时尤为多见。小儿由于身体机能尚未发育完全,防病抗病能力较弱,发病率远远高于成年人,并且症状比成年人更加严重,通常会咳嗽不止,夜间尤甚。小儿夜咳是指儿童咳嗽以夜间出现或加重,白天无咳或偶咳,有痰或无痰,缠绵难愈,往往伴随其他脏腑病变表现,是临床上儿童常见疾病中相对棘手的症状之一,对患儿的学习和生活质量造成严重影响。由于小儿正处于生长发育阶段,身体器官娇嫩,脏腑功能尚未发育完善,用药需要尤为慎重,成人使用的药品不可随意给小儿使用,以防给小儿身体造成损害,因此小儿用药可选范围很小。现有的小儿止咳药物,有的治标不治本,未从根本上解决咳嗽的病因,有的治疗效果不甚理想,导致病情反反复复;目前已上市针对小儿咳嗽的成药多以润肺为主,未见专门针对小儿夜咳用药的成方制剂。因此,研发一种针对小儿夜间咳嗽治疗效果好且安全无副作用的药物是很有必要的。
发明内容
针对现有技术存在的不足,本发明的目的在于提供一种治疗小儿夜间咳嗽的药物组合物及其制剂和应用。本发明所述的药物组合物具有疏肝解郁、止咳化痰、健脾养阴的功效,用于治疗小儿夜间咳嗽疗效显著、且安全无副作用。
本发明的目的是通过以下技术方案实现的:
一种治疗小儿夜间咳嗽的药物组合物,按重量份数计,由如下组分组成:柴胡3-15份、白芍3-15份、枳实3-12份、炒谷芽6-15份、炒麦芽6-15份、陈皮3-12份、法夏3-12份、蜜紫菀3-12份、白前3-12份、前胡3-12份、天花粉3-15份、麦冬3-15份、淡豆豉3-15份、炙甘草2-10份。
优选地,所述治疗小儿夜间咳嗽的药物组合物,按重量份数计,由如下组分组成:柴胡3-10份、白芍6-15份、枳实3-10份、炒谷芽9-15份、炒麦芽9-15份、陈皮3-10份、法夏3-9份、蜜紫菀5-10份、白前3-10份、前胡3-10份、天花粉3-10份、麦冬6-12份、淡豆豉6-12份、炙甘草3-9份。
更优选地,所述治疗小儿夜间咳嗽的药物组合物,按重量份数计,由如下组分组成:柴胡6-10份、白芍6-10份、枳实5-10份、炒谷芽9-15份、炒麦芽9-15份、陈皮6-10份、法夏6-10份、蜜紫菀6-10份、白前6-10份、前胡6-10份、天花粉5-10份、麦冬6-10份、淡豆豉6-10份、炙甘草5-10份。
本发明所述的药物组合物中,柴胡入肝胆经,疏肝解郁,透邪外出,白芍敛阴养血柔肝,二药合用,疏肝与柔肝并用,枳实消积化痰、行气止痛,三药合用理气与和血并行,抑制肝经郁火犯肺,加以健脾开胃的炒谷芽、炒麦芽合为君药,达到肝脾同调之功效;陈皮、法半夏(法夏)燥湿化痰、健脾调中,与入肺经的蜜紫菀、白前、前胡配伍其药性温而不热,润而不腻,辅助君药发挥健脾化湿、止咳化痰之功;佐以清热泻火、润肺生津的天花粉、麦冬、淡豆豉,治疗燥伤肺胃、咽干口渴的同时又能透散外邪以除烦;炙甘草润肺止咳、调和诸药为使,全方共凑疏肝解郁,止咳化痰,健脾养阴之功。
所述治疗小儿夜间咳嗽的药物组合物,还可以添加药学上可接受的辅料,制成汤剂、口服液、中药合剂、膏剂、颗粒剂、丸剂等制剂。
所述药物组合物及其制剂,可用于制备治疗小儿夜间咳嗽的药物,具有疏肝解郁、止咳化痰、健脾养阴的功效,用于治疗小儿夜间咳嗽。
与现有技术相比,本发明具有的有益效果:
1、本发明所述的治疗小儿夜间咳嗽的药物组合物及其制剂,用于治疗小儿夜间咳嗽,疗效显著,且安全无副作用。
2、由于小儿脏腑娇嫩,形气未充,卫外机能尚未完善,故易感受外邪,由表而入,肺气失宣肃,引发咳嗽。且小儿的生理特点是肝常有余,心常有余,脾常不足,肺常虚,故心、肝、脾、肺四者生理上相互制约,一旦失去平衡,都可促使小儿咳嗽。结合小儿夜咳的病理特点:小儿夜咳常发生于23:00至3:00,此时主要为胆肝经所主,肝与肺为气机升降之枢纽,肺居膈上,其气肃降,肝居膈下,其气升发,升降相宜才可气机调畅。且足厥阴肝经布胸胁,分支注于肺。若肝失疏泄,气郁于肝,则肺难肃降,气逆致咳。该制剂在疏肝理气的同时,也能起到“培土生金”之意,从而调节机体各脏腑器官,达到整体调理的作用。
3、本发明所述的治疗小儿夜间咳嗽的药物组合物及其制剂为纯中药制剂,没有任何毒副作用。
4、本发明所述的治疗小儿夜间咳嗽的药物组合物制剂口感适中,小儿易于接受。
5、本发明所述的治疗小儿夜间咳嗽的药物组合物及其制剂,药物价格低廉,服用疗效好,服用周期短。
具体实施方式
下面结合实施例对本发明作进一步说明,但本发明并不局限于实施例。
实施例1
一种治疗小儿夜间咳嗽的药物组合物,由如下组分组成:滇柴胡6g、白芍6g、枳实5g、炒谷芽9g、炒麦芽9g、陈皮6g、法夏6g、蜜紫菀6g、白前6g、前胡6g、天花粉5g、麦冬6g、淡豆豉6g、炙甘草5g。
实施例2
一种治疗小儿夜间咳嗽的药物组合物,由如下组分组成:滇柴胡3g、白芍3g、枳实3g、炒谷芽6g、炒麦芽6g、陈皮3g、法夏3g、蜜紫菀3g、白前3g、前胡3g、天花粉3g、麦冬3g、淡豆豉3g、炙甘草2g。
实施例3
一种治疗小儿夜间咳嗽的药物组合物,由如下组分组成:柴胡15g、白芍15g、枳实12g、炒谷芽15g、炒麦芽15g、陈皮12g、法夏12g、蜜紫菀12g、白前12g、前胡12g、天花粉15g、麦冬15g、淡豆豉15g、炙甘草10g。
实施例4
一种治疗小儿夜间咳嗽的药物组合物,由如下组分组成:柴胡9g、白芍8g、枳实8g、炒谷芽10g、炒麦芽10g、陈皮8g、法夏9g、蜜紫菀6g、白前8g、前胡8g、天花粉9g、麦冬9g、淡豆豉10g、炙甘草5g。
实施例5
一种治疗小儿夜间咳嗽的药物组合物,由如下组分组成:滇柴胡3g、白芍6g、枳实8g、炒谷芽10g、炒麦芽12g、陈皮12g、法夏3g、蜜紫菀5g、白前8g、前胡10g、天花粉15g、麦冬3g、淡豆豉6g、炙甘草9g。
实施例6
一种治疗小儿夜间咳嗽的药物组合物,由如下组分组成:柴胡6g、白芍8g、枳实10g、炒谷芽12g、炒麦芽15g、陈皮3g、法夏6g、蜜紫菀6g、白前10g、前胡12g、天花粉3g、麦冬6g、淡豆豉10g、炙甘草10g。
实施例7
一种治疗小儿夜间咳嗽的药物组合物,由如下组分组成:滇柴胡9g、白芍10g、枳实12g、炒谷芽15g、炒麦芽6g、陈皮6g、法夏9g、蜜紫菀10g、白前12g、前胡3g、天花粉5g、麦冬9g、淡豆豉12g、炙甘草2g。
实施例8
一种治疗小儿夜间咳嗽的药物组合物,由如下组分组成:柴胡10g、白芍15g、枳实3g、炒谷芽6g、炒麦芽9g、陈皮8g、法夏10g、蜜紫菀12g、白前3g、前胡6g、天花粉9g、麦冬10g、淡豆豉15g、炙甘草3g。
实施例9
一种治疗小儿夜间咳嗽的药物组合物,由如下组分组成:滇柴胡15g、白芍3g、枳实5g、炒谷芽9g、炒麦芽10g、陈皮10g、法夏12g、蜜紫菀3g、白前6g、前胡8g、天花粉10g、麦冬15g、淡豆豉3g、炙甘草5g。
实施例10
一种治疗小儿夜间咳嗽的药物组合物的汤剂,按照实施例1-9任意一项所述的药物组合物的重量称取药材,按以下步骤进行制备:全部药材用5倍量冷水浸泡20min,大火煮沸,小火煮40min,煎至约原体积的60%,即得。
应用实施例1——本发明所述的治疗小儿夜间咳嗽的药物组合物用于治疗小儿夜间咳嗽的疗效观察
1、临床资料收集
收集的100例病例均来源于我院患者,其中男64例,女36例;年龄1个月至12岁;病程1天至3个月;就诊前他处治疗62例,未治38例。临床表现:夜间或入睡后出现咳嗽,多于子、丑时咳嗽,呈刺激性咳嗽,干咳为主,偶有痰,甚则咳而欲吐,或伴咳剧呕吐,体温正常,无呼吸困难,白天不咳或偶咳,多无明显其他症状,饮食二便正常,X线胸片及血常规正常。排除以咳嗽为主症的其他疾病(支气管炎、肺炎、肺结核等)。
2、治疗方法
将100例病例随机分为治疗组和对照组,每组50例,两组患者在年龄、病程、及病情评分方面评估组间差异均无统计学意义(P>0.05),具有可比性。
治疗组:服用药物为实施例1所述的药物组合物按照实施例10所述方法制得的汤剂,口服,每日l剂,分为四次服用,分别为早、中、晚饭后、以及夜间10点30分各服一次。不同年龄段服药剂量不同:0.1-2岁15-30mL/次、2-5岁60mL/次、5-9岁90mL/次。
对照组:予以常规治疗,口服复方甲氧那明20mg,3次/d,并口服西替利嗪2.5-5.0mg,1次/d。
3、信息收集方式:病人复诊或电话回访。
4、评价标准:
(1)中医证候积分,评分标准参考《中药新药临床研究指导原则》,分数越高咳嗽症状越严重:①夜间咳嗽症状消失,其他症状消失为痊愈,记0分;②咳嗽基本消失,其他症状明显减轻为显效,记1分;③咳嗽减轻,其他症状稍减为有效,记2分;④咳嗽未见明显改善,其他症状未减为无效,记3分。总有效率=(痊愈+显效+有效)/总例数。比较两组临床不良反应,包括口干舌燥、头晕不适、恶心呕吐等。
(2)咳嗽症状评分:参考咳嗽评分标准评估患儿用药前及用药2周后的咳嗽程度,根据咳嗽强度和频率进行评分,分数越低效果越好:无咳嗽症状记0分;偶尔或夜间短暂性咳嗽记1分;频繁咳嗽,对正常生活造成轻度影响记2分;频繁咳嗽,严重影响日常活动,夜间咳嗽加剧记为3分。
5、治疗效果:服药2-4剂后观察疗效。
6、结果
治疗组治愈(咳嗽消失,患儿一切如常,3个月内无复发)35例,好转(咳嗽明显减轻,包括显效和有效)10例,未愈(咳嗽无变化,无效)5例,总有效率为90%;对照组总有效率为60%,且复发率较高,见表1。
从表2可知,对照组与治疗组均可降低咳嗽程度及中医症候积分,但两组降低程度有差异:①与对照组相比,治疗组咳嗽程度评分降低更多,且两组间差异有统计学意义,P<0.05;②与对照组相比,治疗组中医证候积分降低更多,且两组间差异有统计学意义,P<0.05。
综上,本发明所述组合物的汤剂治疗小儿夜咳的临床疗效显著,有效率达 90%,未发现任何不良反应。
应用实施例2——本发明所述的药物组合物的制剂用于治疗小儿夜间咳嗽的临床病例
病例1:患者刘某,男,8岁,10天前感受风寒后出现发热,咳嗽,咽痛,二便调,舌红,苔薄白微燥,脉弦,经西医对症治疗2天后体温恢复正常,咽痛消失,但咳嗽由白天转为夜间一点至两点,且烦躁不安,蹬被子,不思饮食,连续八天如此,到我院就诊后给实施例1所述的药物组合物,嘱咐病人按照实施例10所述方法制得汤剂口服,当夜10点半服用组合物汤剂90mL,咳嗽有所减轻,烦躁不安的情况明显缓解,连服2剂后咳嗽停止,思饮食,诸证痊愈。
病例2:患者张某,男,3岁,8天前感受风寒后出现咳嗽,痰多,色白,昼夜皆咳,夜间为甚,纳差,烦躁不安,二便调,舌淡红,苔薄白微燥,脉弦。于就诊当夜10点半服用组合物汤剂60mL后半小时,咳嗽开始减轻,烦躁不安的情况明显缓解,于第二天服完一剂后,咳嗽停止,思饮食,诸证痊愈。本病例服用的药物为实施例6所述的药物组合物,嘱咐病人按照实施例10所述方法制得汤剂服用。
病例3:患者李某,女,5岁,6天前感受风寒后出现发热,咳嗽,流鼻涕,打喷嚏,二便调,舌淡红,苔薄白,浮紧,经西医对症治疗1天后体温恢复正常,除咳嗽外其它症状消失,咳嗽由白天转为夜间十一点至三点,且烦躁不安,蹬被子,不思饮食,连续5天如此,服用中西药无明显效果,到我院就诊后给组合物汤剂口服,当夜10点半服用组合物汤剂60mL,咳嗽有所减轻,烦躁不安的情况明显缓解,连服3剂后咳嗽停止,思饮食,诸证痊愈。本病例服用的药物为实施例9所述的药物组合物,嘱咐病人按照实施例10所述方法制得汤剂服用。
Claims (8)
1.一种治疗小儿夜间咳嗽的药物组合物,其特征在于,按重量份数计,由如下组分组成:柴胡3-15份、白芍3-15份、枳实3-12份、炒谷芽6-15份、炒麦芽6-15份、陈皮3-12份、法夏3-12份、蜜紫菀3-12份、白前3-12份、前胡3-12份、天花粉3-15份、麦冬3-15份、淡豆豉3-15份、炙甘草2-10份。
2.根据权利要求1所述的治疗小儿夜间咳嗽的药物组合物,其特征在于,按重量份数计,由如下组分组成:柴胡3-10份、白芍6-15份、枳实3-10份、炒谷芽9-15份、炒麦芽9-15份、陈皮3-10份、法夏3-9份、蜜紫菀5-10份、白前3-10份、前胡3-10份、天花粉3-10份、麦冬6-12份、淡豆豉6-12份、炙甘草3-9份。
3.根据权利要求2所述的治疗小儿夜间咳嗽的药物组合物,其特征在于,按重量份数计,由如下组分组成:柴胡6-10份、白芍6-10份、枳实5-10份、炒谷芽9-15份、炒麦芽9-15份、陈皮6-10份、法夏6-10份、蜜紫菀6-10份、白前6-10份、前胡6-10份、天花粉5-10份、麦冬6-10份、淡豆豉6-10份、炙甘草5-10份。
4.权利要求1至3任意一项所述的治疗小儿夜间咳嗽的药物组合物的制剂,其特征在于,所述制剂由所述药物组合物添加药学上可接受的辅料,制成制剂。
5.根据权利要求4所述的治疗小儿夜间咳嗽的药物组合物的制剂,其特征在于,所述制剂为汤剂。
6.权利要求5所述的治疗小儿夜间咳嗽的药物组合物的制剂的制备方法,其特征在于,包括以下步骤:全部药材用5倍量冷水浸泡20min,大火煮沸,小火煮40min,煎至原体积的60%,即得。
7.权利要求1至3任意一项所述的治疗小儿夜间咳嗽的药物组合物的应用,其特征在于,所述药物组合物在制备治疗小儿夜间咳嗽的药物中的应用。
8.权利要求4所述的治疗小儿夜间咳嗽的药物组合物的制剂的应用,其特征在于,所述药物组合物的制剂在制备治疗小儿夜间咳嗽的药物中的应用。
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