CN105477430A - 一种含艾叶的预防和/或治疗小儿反复感冒的中药制剂 - Google Patents
一种含艾叶的预防和/或治疗小儿反复感冒的中药制剂 Download PDFInfo
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Abstract
本发明属于中药领域,涉及一种含艾叶的预防和/或治疗小儿反复感冒的中药制剂。该中药制剂由以下重量份数的原料制备而成:艾叶18-26份、麻黄16-23份、荆芥13-19份、石菖蒲15-21份、竹叶13-19份、百合12-16份、虎耳草10-15份、鹰嘴豆9-13份、白苏叶7-12份、贯众6-12份、紫草8-14份、荔枝草7-13份和甘草7-12份。本发明中药制剂具有清热解毒、祛痰止咳、宣肺平喘、补脾益气和凉血之功效,对于小儿感冒引起的发热、咳嗽、流涕、鼻塞、呕吐、腹泻等症状均具有显著疗效。本发明中药制剂选取的药材原料配伍合理,成本低廉且无任何毒副作用,适合小儿服用,值得临床上广泛推广。
Description
技术领域
本发明属于中药领域,尤其涉及一种含艾叶的预防和/或治疗小儿反复感冒的中药制剂。
背景技术
小儿感冒即小儿急性上呼吸道感染,是指喉部以上、上呼吸道鼻咽部的急性感染,亦简称“上感”。小儿感冒以病毒为主,除此外可有支原体和细菌感染,全年均可发生,以冬春季较多,幼儿期发病最多,学龄儿童逐渐减少。
体虚感冒是中医的病证名称,是以反复发作,缠绵难愈为特点的临床常见疾病,主要见于体弱之小儿。反复感冒,出现呼吸道感染,多因肺脾两虚、邪毒留伏所致。反复感冒由的主要原因有:居住环境不良,大气污染、被动吸烟等;维生素以及微量元素的缺乏;先天性疾病;免疫缺陷病;滥用抗生素,并多次更换,产生耐药,而且打乱人体的一些平衡;疗程不够,擅自停药,发烧一退就停药;滥用激素;临床误诊;不良习惯。
目前对于小儿感冒的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、抗组胺药等为主,这些药物副作用多,有的甚至会引起严重的不良反应,对儿童的健康恢复极为不利;中医在治疗小儿感冒方面,主要以中成药为主,不仅剂量大、药物吸收慢,且患者接受程度差,长时间不见好转,往往会延误病情,使病情加重。
中国专利申请201310634057公开了一种治疗小儿感冒的口服液,该口服液由以下重量份的原料制备而成:爵床、荩草、盘肠草、天竺黄、木蓝、玉米须、桔梗、蝉蜕、紫菀、杨桃、百合、黄柏、胡萝卜、葛根、白薇和甘蔗,该发明口服液具有清热解毒、祛痰止咳、润肺降气之功效,但是该口服液成分复杂,治疗小儿感冒治标不治本,愈后易复发。
发明内容
本发明要解决的技术问题是提供一种含艾叶的预防和/或治疗小儿反复感冒的中药制剂,该中药制剂具有清热解毒、祛痰止咳、宣肺平喘、补脾益气和凉血的功效,还具有疗效好,副作用低,标本兼治和服用方便等优点。此外,本发明还提供相应的制造工艺将该中药制剂在保证疗效的前提下制成方便易用的制剂。
本发明中药制剂由以下重量份数的原料制备而成:
艾叶18-26份、麻黄16-23份、荆芥13-19份、石菖蒲15-21份、竹叶13-19份、百合12-16份、虎耳草10-15份、鹰嘴豆9-13份、白苏叶7-12份、贯众6-12份、紫草8-14份、荔枝草7-13份和甘草7-12份。
进一步地,所述中药制剂由以下重量份数的原料制备而成:
艾叶18份、麻黄16份、荆芥13份、石菖蒲15份、竹叶13份、百合12份、虎耳草10份、鹰嘴豆9份、白苏叶7份、贯众6份、紫草8份、荔枝草7份和甘草7份。
进一步地,所述中药制剂由以下重量份数的原料制备而成:
艾叶26份、麻黄23份、荆芥19份、石菖蒲21份、竹叶19份、百合16份、虎耳草15份、鹰嘴豆13份、白苏叶12份、贯众12份、紫草14份、荔枝草13份和甘草12份。
进一步地,所述中药制剂由以下重量份数的原料制备而成:
艾叶22份、麻黄20份、荆芥16份、石菖蒲18份、竹叶16份、百合14份、虎耳草12份、鹰嘴豆11份、白苏叶9份、贯众9份、紫草10份、荔枝草11份和甘草9份。
进一步地,所述中药制剂被制成胶囊剂、片剂、散剂、口服液、颗粒剂或丸剂。
相应地,本发明还提供所述中药制剂的制备方法,包含下述步骤:
S1、按比例称取各味原料药材;
S2、将艾叶、麻黄、荆芥、石菖蒲、竹叶、百合、虎耳草、鹰嘴豆、白苏叶、贯众、紫草、荔枝草和甘草分别去杂质,洗净,烘干,粉碎成粗粉;
S3、将艾叶、麻黄、荆芥、石菖蒲、竹叶、百合、虎耳草、鹰嘴豆、白苏叶、贯众、紫草、荔枝草和甘草制备的粗粉混合,加6-9倍药材重量的纯化水,煎煮2-3次,每次1-3小时,过滤,合并滤液,浓缩成55-65℃时相对密度为1.15-1.20的水提浓缩液,即为所述的中药制剂。
本发明所用组分的来源、性味、归经及功效:
艾叶:为菊科植物艾的干燥叶;味辛、苦,性温,归肝、脾、肾经;温经止血,散寒止痛,调经安胎,除湿止痒,通经活络。
麻黄:为麻黄科植物草麻黄、中麻黄或木贼麻黄的干燥草质茎;味辛、微苦,性温;归肺、膀胱经;发汗散寒,宣肺平喘,利水消肿。
荆芥:为唇形科植物荆芥的干燥地上部分;味辛,性微温;归肺、肝经;解表散风,透疹。
石菖蒲:为天南星科植物石菖蒲的干燥根茎;味辛、苦,性温;归心、胃经;化湿开胃,开窍豁痰,醒神益智。
竹叶:为禾本科植物淡竹的叶;味甘淡,性寒;入心、肺、胆、胃经;清热除烦,生津利尿。
百合:为百合科植物卷丹、百合或细叶百合的干燥肉质鳞叶;味甘,性寒;归心、肺经;养阴润肺,清心安神。
虎耳草:为虎耳草科植物虎耳草的全草;味苦、辛,性;归肺、脾、大肠经;疏风,清热,凉血解毒。
鹰嘴豆:为蔷薇目豆科草本植物;味甘,性平;归肺、胃经;清热解毒。
白苏叶:为唇形科植物白苏的叶片;味辛,性温;入手、足太阴经;解表,散寒,理气,消食。
贯众:为鳞毛蕨科植物粗茎鳞毛蕨,蹄盖蕨科植物蛾眉蕨,球子蕨科植物荚果蕨,紫萁科植物紫萁,乌毛蕨科植物乌毛蕨、苏铁蕨、狗脊蕨等的根茎;味苦,性凉;入肝、胃经;杀蛔、绦、蛲虫,清热,解毒,凉血,止血。
紫草:为紫草科植物新疆紫草、紫草或内蒙紫草的干燥根;味甘、咸,性寒;归心、肝经;凉血,活血,解毒透疹。
荔枝草;为唇形科鼠尾草属植物荔枝草的全草;味苦、辛,性凉;归肺、胃经;清热解毒,利尿消肿,凉血止血。
甘草:本品为豆科植物甘草、胀果甘草或光果甘草的干燥根。味甘,性平;归心、肺、脾、胃经;补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。
本发明中药的组方分析:
依据中医对小儿感冒的辨证和中药材的配伍理论,结合现代人的身体素质和现代制药技术的特点,合理科学的搭配各味药材,形成本发明中药组方。本发明组方是以艾叶和麻黄为君药,散寒止痛,通经活络,宣肺平喘,利水消肿;以荆芥、石菖蒲和竹叶为臣药,解表散风,化湿开胃,开窍豁痰,清热除烦,生津利尿;以百合、虎耳草、白苏叶、贯众、紫草、荔枝草和鹰嘴豆为佐药,养阴润肺,疏风,清热,解表,散寒,理气,凉血解毒;以甘草为使药,补脾益气,清热解毒,祛痰止咳,调和诸药;君臣佐使诸药配合,协同促进,相辅相成,最终达到发汗散寒,宣肺平喘,清热解毒和凉血的功效,用于治疗小儿感冒疗效显著。
与现有技术相比,本发明具有如下技术优势:
1、动物实验显示,本发明中药制剂能够显著降低干酵母致大鼠发热的大鼠体温,表明本发明中药制剂对发热有明显的降温作用。本发明中药制剂临床用于治疗小儿感冒治愈率高,无复发病例,治疗效果显著。
2、与当前预防和/或治疗小儿反复感冒的化学治疗药物相比,本发明中药制剂为天然纯中药制剂,不良反应和副作用显著降低,且本发明中药制剂作用全面,药物治疗效果更佳,有效地解决了小儿反复感冒的发病根源,并提高了患者的生活质量。
3、本发明中药制剂还具有配伍科学,疗效迅速,见效快、疗程短、治愈率高、费用小等优点。
具体实施方式
本领域技术人员应理解,以下实施例中所公开的技术代表本发明人发现的在本发明的实践中发挥良好作用的技术。然而,在所公开的具体实施方案中可以做出许多改变,并仍然获得相同或相似的结果,而不脱离本发明的精神和范围。
实施例1:
本发明实施例1中药制剂由以下重量份数的原料制备而成:艾叶18份、麻黄16份、荆芥13份、石菖蒲15份、竹叶13份、百合12份、虎耳草10份、鹰嘴豆9份、白苏叶7份、贯众6份、紫草8份、荔枝草7份和甘草7份。
制备方法如下:
S1、按比例称取各味原料药材;
S2、将艾叶、麻黄、荆芥、石菖蒲、竹叶、百合、虎耳草、鹰嘴豆、白苏叶、贯众、紫草、荔枝草和甘草分别去杂质,洗净,烘干,粉碎成粗粉;
S3、将艾叶、麻黄、荆芥、石菖蒲、竹叶、百合、虎耳草、鹰嘴豆、白苏叶、贯众、紫草、荔枝草和甘草制备的粗粉,加7倍药材重量的纯化水,煎煮2次,每次3小时,过滤,合并滤液,浓缩成60℃时相对密度为1.20的水提浓缩液,备用;
S4、将S3所得水提浓缩液利用现代先进的制药科技,制成口服液,即为所述的中药制剂。
实施例2:
本发明实施例2中药制剂由以下重量份数的原料制备而成:艾叶26份、麻黄23份、荆芥19份、石菖蒲21份、竹叶19份、百合16份、虎耳草15份、鹰嘴豆13份、白苏叶12份、贯众12份、紫草14份、荔枝草13份和甘草12份。
制备方法同实施例1。
实施例3:
本发明实施例3中药制剂由以下重量份数的原料制备而成:艾叶20份、麻黄28份、荆芥14份、石菖蒲16份、竹叶14份、百合13份、虎耳草11份、鹰嘴豆10份、白苏叶8份、贯众7份、紫草9份、荔枝草9份和甘草8份。
制备方法同实施例1。
实施例4:
本发明实施例4中药制剂由以下重量份数的原料制备而成:艾叶22份、麻黄20份、荆芥16份、石菖蒲18份、竹叶16份、百合14份、虎耳草12份、鹰嘴豆11份、白苏叶9份、贯众9份、紫草10份、荔枝草11份和甘草9份。
制备方法同实施例1。
本发明中药制剂对干酵母致大鼠发热影响的研究实验
一、实验动物:SD大鼠50只,雌雄各半,体质量180~220g,SPF级,由中山大学实验动物中心提供。
二、实验药物:本发明实施例3制备得到的口服液;阳性对照药为小儿感冒口服液(北京同仁堂科技发展股份有限公司制药厂,国药准字Z10009204)。
三、干酵母致大鼠发热:选取体温较为恒定的大鼠50只,雌雄各半,随机按体质量分为5组,分别为模型组、阳性对照组(1.2g/kg)和本发明中药制剂的低、中、高(0.3、0.6、1.2g/kg)剂量组。给药前1d,将SD大鼠腹部剃毛,给药当日测大鼠肛温2~3次,取其平均值作为基础肛温。各组灌胃给药30min后,每只大鼠以10ml/kg背部皮下注射15%干酵母悬液,分别于2、4、6、8h测定肛温,记录肛温变化值。
四、实验结果
表1本发明中药制剂对酵母致大鼠发热的影响
注:与模型对照组相比,*P<0.05,**P<0.01,***P<0.001;与阳性对照组相比,#P<0.05,##P<0.01。
对酵母致大鼠发热的影响实验结果表明,本发明中药制剂各剂量组对发热大鼠均有显著的解热作用,并且可持续8h,本发明中、高剂量组的解热效果尤为显著,解热效果显著优于阳性对照组。实验结果表明本发明中药制剂对发热有明显的降温作用。
本发明中药制剂对小儿反复感冒症临床志愿者患者的疗效观察
一、诊断标准
参照中华人民共和国卫生部《流行性感冒诊治标准与治疗指南(2011版)》中小儿感冒的诊断标准:
1、发热、咳嗽、流涕、鼻塞及咽痛、头痛,少部分出现肌痛、呕吐、腹泻;
2、发热为轻、中度热,无寒颤;
3、无明显全身症状。
二、疗效标准
参照中华人民共和国卫生部《流行性感冒诊治标准与治疗指南(2011版)》中小儿感冒的疗效评定标准:
治愈:发热、咳嗽、流涕、鼻塞及咽痛等症状消失,自我感觉舒适;
有效:发热、咳嗽、流涕、鼻塞及咽痛等症状减轻;
无效:服药后病情无明显变化。
三、临床试验
1、一般资料
将500名入选的小儿感冒临床志愿者患者随机均分成5组,每组100人,分别为治疗A组,治疗B组、治疗C组、治疗D组和对照组,各组年龄、症状等影响因素,经统计学处理,无显著性差异,符合分组条件。
2、治疗方法
治疗A组:服用实施例1制备得到的口服液(10ml*10支/盒),每日2次,每次10ml,连服两周;
治疗B组:服用实施例2制备得到的口服液(10ml*10支/盒),每日2次,每次10ml,连服两周;
治疗C组:服用实施例3制备得到的口服液(10ml*10支/盒),每日2次,每次10ml,连服两周;
治疗D组:服用实施例4制备得到的口服液(10ml*10支/盒),每日2次,每次10ml,连服两周;
对照组:服用小儿感冒口服液(北京同仁堂科技发展股份有限公司制药厂,国药准字Z10009204,10ml*10支/盒),一次10ml,一日2次,连服两周。
3、治疗结果,如表2所示。
表2治疗效果
本试验采用小儿感冒口服液作为对照组,小儿感冒口服液由广藿香、菊花、连翘、大青叶、板蓝根、地黄、地骨皮、白薇、薄荷和石膏等中药精心提炼而成,具有清热解表的功效,临床上用于治疗小儿外感风热感冒,通过与本发明中药制剂治疗效果进行比较,可以发现本发明中药制剂在治疗小儿感冒方面的疗效均优于阳性对照组,其中以治疗组C组最好,总有效率可达到97%。对本发明中药制剂治疗组临床治愈的患者进行为期3个月的随访,无复发病例。可见,本发明中药制剂疗效好,治愈率高,复发率低,可以作为治疗小儿感冒的药物使用。
由于已经通过以上较佳实施例描述了本发明,在本发明的精神和/或范围内,任何针对本发明的替换/或组合来实施本发明,对于本领域的技术人员来说都是显而易见的,且包含在本发明之中。
Claims (6)
1.一种含艾叶的预防和/或治疗小儿反复感冒的中药制剂,其特征在于,所述中药制剂由以下重量份数的原料制备而成:
艾叶18-26份、麻黄16-23份、荆芥13-19份、石菖蒲15-21份、竹叶13-19份、百合12-16份、虎耳草10-15份、鹰嘴豆9-13份、白苏叶7-12份、贯众6-12份、紫草8-14份、荔枝草7-13份和甘草7-12份。
2.如权利要求1所述的含艾叶的预防和/或治疗小儿反复感冒的中药制剂,其特征在于,所述中药制剂由以下重量份数的原料制备而成:
艾叶18份、麻黄16份、荆芥13份、石菖蒲15份、竹叶13份、百合12份、虎耳草10份、鹰嘴豆9份、白苏叶7份、贯众6份、紫草8份、荔枝草7份和甘草7份。
3.如权利要求1所述的含艾叶的预防和/或治疗小儿反复感冒的中药制剂,其特征在于,所述中药制剂由以下重量份数的原料制备而成:
艾叶26份、麻黄23份、荆芥19份、石菖蒲21份、竹叶19份、百合16份、虎耳草15份、鹰嘴豆13份、白苏叶12份、贯众12份、紫草14份、荔枝草13份和甘草12份。
4.如权利要求1所述的含艾叶的预防和/或治疗小儿反复感冒的中药制剂,其特征在于,所述中药制剂由以下重量份数的原料制备而成:
艾叶22份、麻黄20份、荆芥16份、石菖蒲18份、竹叶16份、百合14份、虎耳草12份、鹰嘴豆11份、白苏叶9份、贯众9份、紫草10份、荔枝草11份和甘草9份。
5.如权利要求1-4任一所述的含艾叶的预防和/或治疗小儿反复感冒的中药制剂,其特征在于,所述中药制剂被制成胶囊剂、片剂、散剂、口服液、颗粒剂或丸剂。
6.如权利要求1-5任一所述的含艾叶的预防和/或治疗小儿反复感冒的中药制剂的制备方法,其特征在于,所述中药制剂的制备方法包含下述步骤:
S1、按比例称取各味原料药材;
S2、将艾叶、麻黄、荆芥、石菖蒲、竹叶、百合、虎耳草、鹰嘴豆、白苏叶、贯众、紫草、荔枝草和甘草分别去杂质,洗净,烘干,粉碎成粗粉;
S3、将艾叶、麻黄、荆芥、石菖蒲、竹叶、百合、虎耳草、鹰嘴豆、白苏叶、贯众、紫草、荔枝草和甘草制备的粗粉混合,加6-9倍药材重量的纯化水,煎煮2-3次,每次1-3小时,过滤,合并滤液,浓缩成55-65℃时相对密度为1.15-1.20的水提浓缩液,即为所述的中药制剂。
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