CN107875355B - 一种治疗喉痧的中药制剂及其制备方法 - Google Patents
一种治疗喉痧的中药制剂及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗喉痧的中药制剂及其制备方法,它是由中药原料山豆根、鲜牛蒡子叶、蒲公英、鬼针草、鱼腥草、贯众、一枝黄花、野菊花、黄柏、白花蛇舌草、紫花地丁、牛膝根、虎杖、金银花、连翘、玄参、黄芩、板蓝根、知母、栀子、生地、牡丹皮、钩藤、三颗针、麦冬、僵蚕、蝉蜕、姜黄、生大黄制备而得,本发明的技术方案制备的苗药清热解毒退痧方治疗喉痧具有良好的清热解毒、消肿利湿、生津利咽、熄风止痉之功效。临床上用于喉痧疗效确切,且安全性好。
Description
技术领域
本发明涉及中药技术领域,特别是涉及一种治疗喉痧的中药制剂及其制备方法。
背景技术
猩红热为A组β型溶血性链球菌(也称为化脓链球菌)感染引起的急性呼吸道传染病。猩红热属于中医学温病范畴,其名为“烂喉痧”、“烂喉丹痧”、“疫喉痧”等,民间俗称“喉痧”。本病由痧毒疫疠之邪乘时令不正之气,侵入人体,邪由口鼻而入,蕴于肺胃两经。邪毒化火,上攻咽喉,则红肿、疼痛。毒从肌表而透,发为痧疹。毒邪伤及心气,致心悸、脉结代;后期热毒未清,流窜关节,致关节肿痛,余邪未尽,内归肺、脾、肾三脏,水液通调失职,可致水肿。因此,研发一种用于治疗喉痧的中药制剂是十分有前景的。
发明内容
本发明所要解决的技术问题是提供一种具有清热解毒、消肿利湿、生津利咽、熄风止痉之功效,且疗效确切的用于治疗喉痧的中药制剂及其制备方法。
为了解决上述技术问题,本发明采用如下的技术方案:按照重量份计算,本发明治疗喉痧的中药制剂是由中药原料山豆根50-70克、鲜牛蒡子叶50-70克、蒲公英15-25克、鬼针草15-25克、鱼腥草30-50克、贯众15-25克、一枝黄花25-35克、野菊花15-25克、黄柏25-35克、白花蛇舌草15-25克、紫花地丁15-25克、牛膝根25-35克、虎杖25-35克、金银花15-25克、连翘8-12克、玄参8-12克、黄芩8-12克、板蓝根8-12克、知母8-12克、栀子8-12克、生地10-15克、牡丹皮8-12克、钩藤12-18克、三颗针12-18克、麦冬15-25克、僵蚕5-8克、蝉蜕7-10克、姜黄8-12克、生大黄5-8克制备而成。
优选为:按照重量份计算,它是由中药原料山豆根60克、鲜牛蒡子叶60克、蒲公英20克、鬼针草20克、鱼腥草40克、贯众20克、一枝黄花30克、野菊花20克、黄柏30克、白花蛇舌草20克、紫花地丁20克、牛膝根30克、虎杖30克、金银花20克、连翘10克、玄参10克、黄芩10克、板蓝根10克、知母10克、栀子10克、生地12克、牡丹皮10克、钩藤15克、三颗针15克、麦冬20克、僵蚕6克、蝉蜕9克、姜黄10克、生大黄6克制备而成。
前述治疗喉痧的中药制剂的制备方法:将山豆根50-70克、鲜牛蒡子叶50-70克、蒲公英15-25克、鬼针草15-25克、鱼腥草30-50克、贯众15-25克、一枝黄花25-35克、野菊花15-25克、黄柏25-35克、白花蛇舌草15-25克、紫花地丁15-25克、牛膝根25-35克、虎杖25-35克、金银花15-25克、连翘8-12克、玄参8-12克、黄芩8-12克、板蓝根8-12克、知母8-12克、栀子8-12克、生地10-15克、牡丹皮8-12克、钩藤12-18克、三颗针12-18克、麦冬15-25克、僵蚕5-8克、蝉蜕7-10克、姜黄8-12克、生大黄5-8克以上29味药物组成按剂量配伍采用1.5倍水煎,每次30分钟,连续水煎3次,合并3次水煎药液,共浓缩成100ml,分装。
本发明在临床观察中针对喉痧取得满意效果。
本发明方中山豆根、牛蒡子、蒲公英、鬼针草、鱼腥草、贯众、野菊花、金银花板蓝根清热、解毒、利咽、散结;一枝黄花、连翘、姜黄疏风、抗菌、消炎;黄柏、白花蛇舌草、紫花地丁、虎杖、黄芩、三颗针、牛膝泻火、凉血、消肿,利湿;玄参、知母滋阴降火、润燥滑肠;栀子清热利尿、消肿止痛;生地清热、生津、润燥、滑肠;牡丹皮活血化淤、消退虚热;钩藤清热平肝、熄风止痉;麦冬生津解渴、润肺止咳;蝉蜕疏散风热,利咽开音,息风止痉。大黄攻积滞、清湿热。。共奏清热解毒、消肿利湿、生津利咽、熄风止痉之功。
本发明的药材质量标准如下:
1.山豆根 本品为豆科植物植物Euchresta japonica的干燥根和根茎,质量标准参见《贵州省地方药材质量标准》2010版“山豆根”项下规定。
2.牛蒡子 本品为菊科二年生草本植物牛蒡Arctium lappa L.的干燥成熟果实质量标准参见《中国药典》2010版“牛蒡子”项下规定。
3.蒲公英 本品为菊科植物蒲公英Toraxacum mongolicum Hand.Mazz.、碱地蒲公英Toraxacum borealisinense Kitam.或同属数种植物的干燥全草,质量标准参见《中国药典》2010版“蒲公英”项下规定。
4.鬼针草 本品为鬼针草Guizhencao HERBA BIDENTIS PILOSAE该品为菊科植物鬼针草Bidens pilosa Linnaeus的干燥全草,质量标准参见《贵州省地方药材质量标准》2010版“鬼针草”项下规定。
5.鱼腥草 本品为三白草科植物蕺菜(拉丁学名:Houttuynia cordata Thunb.)的干燥地上部分,质量标准参见《中国药典》2010版“鱼腥草”项下规定。
6.贯众 本品为乌毛蕨科植物狗脊Woodwardia japonica(L.f.)Smith、紫萁科植物紫萁Osmunda japonica Thunb.或鳞毛蕨科植物贯众Cyrtomium fortunei J.Smith带叶柄基部的干燥根茎,质量标准参见《中国药典》2010版“贯众”项下规定。
7.一枝黄花 本品为菊科植物一枝黄花SolidagodecurrensLour.的全草,质量标准参见《贵州省地方药材质量标准》2010版“一枝黄花”项下规定。
8.野菊花 本品为菊科植物野菊Chrysanthemum indicum L的干燥头状,质量标准参见《中国药典》2010版“野菊花”项下规定。
9.黄柏 本品为芸香科植物黄檗或黄皮树的树皮,质量标准参见《中国药典》2010版“黄柏”项下规定。
10.白花蛇舌草 本品为Hedyotis diffusa为一年生披散草本,质量标准参见《中国药典》2010版“白花蛇舌草”项下规定。
11.紫花地丁 本品为Viola philippica多年生草本,质量标准参见《中国药典》2010版“紫花地丁”项下规定。
12.牛膝 本品为Achyranthes bidentata Blume牛膝属多年生草本植物,质量标准参见《中国药典》2010版“牛膝”项下规定。
13.虎杖 本品蓼科Polygonaceae植物虎杖Polygonum cuspidatum Sieb.etZucc.,的干燥根茎和根,质量标准参见《中国药典》2010版“虎杖”项下规定。
14.金银花 本品为忍冬科忍冬属植物忍冬及同属植物干燥花蕾或带初开的花。质量标准参见《中国药典》2010版“金银花”项下规定。
15.连翘 本品为Forsythia suspensa落叶灌木,质量标准参见《中国药典》2010版“连翘”项下规定。
16.玄参 本品为双子叶植物玄参科Scrophulariaceae玄参ScrophularianingpoensisHemsl.的干燥根,质量标准参见《中国药典》2010版“玄参”项下规定。
17.黄芩 本品为唇形科植物黄芩(Scutellaria baicalensis Georgi),以根入药,质量标准参见《中国药典》2010版“黄芩”项下规定。
18.板蓝根 本品为爵床科植物马蓝(Baphicacanthus cusia(Nees)Brem.)的根茎及根。质量标准参见《中国药典》2010版“板蓝根”项下规定。
19.知母 本品为Anemarrhena asphodeloides Bunge,也叫毛知母,多年生草本植物,根状茎。质量标准参见《中国药典》2010版“知母”项下规定。
20.栀子 本品为双子叶植物药茜草科植物山栀的果实,质量标准参见《中国药典》2010版“栀子”项下规定。
21.生地 本品为玄参科植物怀庆地黄[Rehmannia glutinosa(Gaerin)Libosch.f.huelchingensis(Chao et Schih)Hsiao)],以块根入药,质量标准参见《中国药典》2010版“生地”项下规定。
22.牡丹皮 本品为毛茛科植物牡丹干燥根皮,质量标准参见《中国药典》2010版“牡丹皮”项下规定。
23.钩藤 本品为Uncaria rhynchophylla(Miq.)Miq.exHavil.茜草科钩藤属常绿藤本植物,攀援状灌木,茎枝方柱形纤细无毛,叶纸质呈椭圆形,头状花序。钩藤以带钩的茎枝入药,质量标准参见《中国药典》2015版“钩藤”项下规定。
24.三颗针 本品为小檗科植物刺黑珠、毛叶小檗、黑石珠等的根皮或茎皮,质量标准参见《中国药典》2010版“三颗针”项下规定。
25.麦冬 本品为Ophiopogon japonicus(Linn.f.)Ker-Gawl.百合科沿阶草属多年生常绿草本植物,质量标准参见《中国药典》2010版“麦冬”项下规定。
26.僵蚕 本品为Ardisia crispa(Thunb.)A.DC的根茎,质量标准参见《中国药典》2010版“僵蚕”项下规定。
27.蝉蜕 本品为蝉科昆虫黑蚱羽化后的蜕壳,质量标准参见《中国药典》2010版“蝉蜕”项下规定。
28.姜黄 本品为姜科植物姜黄或郁金的根茎,质量标准参见《中国药典》2010版“姜黄”项下规定。
29.大黄 本品为蓼科植物掌叶大黄Rheum palmatum L.、唐古特大黄R.tanguticum Maxim.ex Balf.或药用大黄R.officinale Baill.的干燥根及根茎,质量标准参见《中国药典》2010版“大黄”项下规定。
本发明的产品名称:苗药清热解毒退痧方。
性状:本发明的产品为棕红液体,气芳香。
功效:清热解毒、消肿利湿、生津利咽、熄风止痉。
用法:每天1剂,每天3次。
本发明的临床试验:
1临床资料
1.1一般资料 所有病例均为喉痧患者。
1.2诊断标准 西医参照《诸福棠实用儿科学》中猩红热的诊断标准,中医参照国家中医药管理局《中医病证诊断疗效标准》中丹痧的诊断依据及中医证候分类。
1.3纳入标准 (1)符合中西医诊断标准;(2)年龄性别不限;(3)病程小于72h,(4)未经其他药物治疗;(5)所有患儿家属均签署知情同意书。(6)自愿作为受试对象,并能接受试验药物剂型,保证完成疗程者。
1.4排除标准 (1)符合中西医诊断标准;(2)就诊前使用抗生素治疗者,合并肺炎等下呼吸道感染者;(3)对实验所用药物过敏者;(4)传染性单核细胞增多症;(5)病毒性咽炎;(6)夏季痒子;(7)未严格按要求参加研究,或重要资料不全者。
1.5终止研究标准 (1)实验中未能坚持按医嘱用药或自行换用其他药物治疗者;(2)实验中喉痧加重不能继续治疗者;(3)出现严重不良事件;(4)临床试验过程中出现严重的其他并发疾病者。
2研究方法
2.1治疗方法
2.1.1分组 本研究采用临床随机对照试验的方法,按照就诊的先后顺序,以随机数字表法随机分成苗药清热解毒退痧方治疗组和对照组,进行临床疗效观察。治疗组:100例,对照组:100例。
2.1.2治疗方法 对照组给予阿莫西林舒巴坦针60~70mg/(kg·d)(青霉素皮试阴性)加入100mL 0.9%氯化钠注射液中,分2次静脉滴注,同时补充维生素及保持水电解质平衡,高热时物理降温,必要时口服布洛芬混悬液(美林)(0.25~0.50mL/kg),患儿保持卧床休息并予呼吸道隔离。
治疗组在对照组治疗基础上加用苗药清热解毒退痧方1剂/d,水煎3次混合后共取汁300mL,分早、中、晚温服。两组均以治疗1周后统计疗效。
2.2观察指标及评定标准
2.2.1.安全性观测
在用药前及疗程结束时各检测一次,如试验过程中出现试验指标的异常,应复查至正常。
(1)一般体格检查;
(2)三大常规;
(3)主症采用量化分级方式,按正常、轻度、中度、重度分别记0,1,2,3分;
(4)临床疗效。
2.2.3疗效标准 参照国家中医药管理局《中医病证诊断疗效标准》拟定。痊愈:症状、体征消失或基本消失,证候积分减少≥95%。显效:症状、体征明显改善,70%≤积分减少<95%。有效:症状、体征均好转,30%≤积分减少<70%。无效:症状、体征无明显改善,甚或加重,证候积分减少不足30%。计算公式(尼莫地平法):[(治疗前总积分-治疗后总积分)÷治疗前总积分]×100%
总有效率=(痊愈例数+显效例数)/总例数×100%。
2.3统计分析 所有资料均在计算机上由SPSS 15.0版本软件包进行分析处理,计量资料数据以X±S表示,组间比较用t检验,分类变量资料的统计分析用χ2检验。P<0.05有统计学意义。
3结果
3.3.1两组临床疗效比较 治疗组100例,痊愈42例,显效43例、有效15例,无效0例,总有效率100%;对照组100例,痊愈20例,显效27例、有效38例,无效15例,总有效率85.00%;两组临床疗效比较,差异有统计学意义(P<0.01)。
3.3.2两组治疗后体温、WBC计数、退热时间、咽痛消退时间及皮疹消退时间比较治疗组体温、WBC计数、退热时间、咽痛消退时间及皮疹消退时间改善明显优于对照组(P<0.05)。见表1。
表1两组治疗后体温、WBC计数、退热时间、咽痛消退时间及皮疹消退时间比较(x±s)
结论:苗药清热解毒退痧方治疗喉痧具有良好的清热解毒、消肿利湿、生津利咽、熄风止痉之功效。临床上用于喉痧疗效确切,且安全性好。
具体实施方式:
实施例1:原料:山豆根60克、鲜牛蒡子叶60克、蒲公英20克、鬼针草20克、鱼腥草40克、贯众20克、一枝黄花30克、野菊花20克、黄柏30克、白花蛇舌草20克、紫花地丁20克、牛膝根30克、虎杖30克、金银花20克、连翘10克、玄参10克、黄芩10克、板蓝根10克、知母10克、栀子10克、生地12克、牡丹皮10克、钩藤15克、三颗针15克、麦冬20克、僵蚕6克、蝉蜕9克、姜黄10克、生大黄6克。
制备方法:将山豆根60克、鲜牛蒡子叶60克、蒲公英20克、鬼针草20克、鱼腥草40克、贯众20克、一枝黄花30克、野菊花20克、黄柏30克、白花蛇舌草20克、紫花地丁20克、牛膝根30克、虎杖30克、金银花20克、连翘10克、玄参10克、黄芩10克、板蓝根10克、知母10克、栀子10克、生地12克、牡丹皮10克、钩藤15克、三颗针15克、麦冬20克、僵蚕6克、蝉蜕9克、姜黄10克、生大黄6克以上29味药物组成按剂量配伍采用1.5倍水煎,每次30分钟,连续水煎3次,合并3次水煎药液,共浓缩成100ml,分装。即得苗药清热解毒退痧方。
实施例2:原料:山豆根50克、鲜牛蒡子叶50克、蒲公英15克、鬼针草15克、鱼腥草30克、贯众15克、一枝黄花25克、野菊花15克、黄柏25克、白花蛇舌草15克、紫花地丁15克、牛膝根25克、虎杖25克、金银花15克、连翘12克、玄参12克、黄芩12克、板蓝根12克、知母12克、栀子12克、生地15克、牡丹皮12克、钩藤18克、三颗针18克、麦冬25克、僵蚕8克、蝉蜕10克、姜黄12克、生大黄8克。
制备方法:将山豆根50克、鲜牛蒡子叶50克、蒲公英15克、鬼针草15克、鱼腥草30克、贯众15克、一枝黄花25克、野菊花15克、黄柏25克、白花蛇舌草15克、紫花地丁15克、牛膝根25克、虎杖25克、金银花15克、连翘12克、玄参12克、黄芩12克、板蓝根12克、知母12克、栀子12克、生地15克、牡丹皮12克、钩藤18克、三颗针18克、麦冬25克、僵蚕8克、蝉蜕10克、姜黄12克、生大黄8克以上29味药物组成按剂量配伍采用1.5倍水煎,每次30分钟,连续水煎3次,合并3次水煎药液,共浓缩成100ml,分装。即得苗药清热解毒退痧方。
实施例3:
原料:山豆根70克、鲜牛蒡子叶70克、蒲公英25克、鬼针草25克、鱼腥草50克、贯众25克、一枝黄花35克、野菊花25克、黄柏35克、白花蛇舌草25克、紫花地丁25克、牛膝根35克、虎杖35克、金银花25克、连翘8克、玄参8克、黄芩8克、板蓝根8克、知母8克、栀子8克、生地10克、牡丹皮8克、钩藤12克、三颗针12克、麦冬15克、僵蚕5克、蝉蜕7克、姜黄8克、生大黄5克。
制备方法:将山豆根70克、鲜牛蒡子叶70克、蒲公英25克、鬼针草25克、鱼腥草50克、贯众25克、一枝黄花35克、野菊花25克、黄柏35克、白花蛇舌草25克、紫花地丁25克、牛膝根35克、虎杖35克、金银花25克、连翘8克、玄参8克、黄芩8克、板蓝根8克、知母8克、栀子8克、生地10克、牡丹皮8克、钩藤12克、三颗针12克、麦冬15克、僵蚕5克、蝉蜕7克、姜黄8克、生大黄5克以上29味药物组成按剂量配伍采用1.5倍水煎,每次30分钟,连续水煎3次,合并3次水煎药液,共浓缩成100ml,分装。即得苗药清热解毒退痧方。
Claims (3)
1.一种治疗喉痧的中药制剂,其特征在于:它是由中药原料山豆根50-70克、鲜牛蒡子叶50-70克、蒲公英15-25克、鬼针草15-25克、鱼腥草30-50克、贯众15-25克、一枝黄花25-35克、野菊花15-25克、黄柏25-35克、白花蛇舌草15-25克、紫花地丁15-25克、牛膝根25-35克、虎杖25-35克、金银花15-25克、连翘8-12克、玄参8-12克、黄芩8-12克、板蓝根8-12克、知母8-12克、栀子8-12克、生地10-15克、牡丹皮8-12克、钩藤12-18克、三颗针12-18克、麦冬15-25克、僵蚕5-8克、蝉蜕7-10克、姜黄8-12克、生大黄5-8克制备而成。
2.根据权利要求1所述治疗喉痧的中药制剂,其特征在于:它是由中药原料山豆根60克、鲜牛蒡子叶60克、蒲公英20克、鬼针草20克、鱼腥草40克、贯众20克、一枝黄花30克、野菊花20克、黄柏30克、白花蛇舌草20克、紫花地丁20克、牛膝根30克、虎杖30克、金银花20克、连翘10克、玄参10克、黄芩10克、板蓝根10克、知母10克、栀子10克、生地12克、牡丹皮10克、钩藤15克、三颗针15克、麦冬20克、僵蚕6克、蝉蜕9克、姜黄10克、生大黄6克制备而成。
3.权利要求1所述治疗喉痧的中药制剂的制备方法,其特征在于:将山豆根50-70克、鲜牛蒡子叶50-70克、蒲公英15-25克、鬼针草15-25克、鱼腥草30-50克、贯众15-25克、一枝黄花25-35克、野菊花15-25克、黄柏25-35克、白花蛇舌草15-25克、紫花地丁15-25克、牛膝根25-35克、虎杖25-35克、金银花15-25克、连翘8-12克、玄参8-12克、黄芩8-12克、板蓝根8-12克、知母8-12克、栀子8-12克、生地10-15克、牡丹皮8-12克、钩藤12-18克、三颗针12-18克、麦冬15-25克、僵蚕5-8克、蝉蜕7-10克、姜黄8-12克、生大黄5-8克以上29味药物组成按剂量配伍采用1.5倍水煎,每次30分钟,连续水煎3次,合并3次水煎药液,共浓缩成100ml,分装。
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