CN117281871A - 一种治疗呼吸道传染病的中药复方和应用 - Google Patents
一种治疗呼吸道传染病的中药复方和应用 Download PDFInfo
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Abstract
本发明提供一种治疗呼吸道传染病的中药复方,是由以下重量份的原料药制成:金银花7‑11份,荆芥7‑11份,黄芪10‑14份,广藿香7‑11份,防风7‑11份,板蓝根7‑11份,桔梗7‑11份,芦根13‑17份,甘草4‑8份。本发明还提供了中药组合物的用途。其优点在于:该中药组合物君臣分明、佐使得当,寒温并用,清补兼顾,肺卫同治,散中兼补,补中寓疏,相反相成,重在透散邪气,益卫固表,共奏疏风清热、扶正固表之功效。
Description
【技术领域】
本发明涉及一种治疗呼吸道传染病的中药复方和应用,具体地说,是以中草药为原料制备的中成药。
【背景技术】
呼吸道传染病是指病原体从人体的鼻腔、咽喉、气管和支气管等呼吸道感染侵入而引起的有传染性的疾病。从古至今,人类遭遇了无数的呼吸道传染病,其中有些呼吸道传染病特别严重,对于人类的生产生活产生了巨大影响。
中国专利CN201610812905.8,公开了一种用于治疗外感发热的中药组合物及其制备方法,该中药是由下述重量配比的原料制成的:金银花10~25g、蒲公英10~32g、大青叶10~18g、葛根10~16g、板蓝根10~32g、赤芍4~12g、柴胡3~12g、黄芩3~10g、秦艽5~12g、荆芥3~12g、淡竹叶9~16g、莱菔子5~12g、桔梗3~12g、苦杏仁3~12g、僵蚕3~12g、广藿香5~12g、知母6~15g、石菖蒲3~8g、郁金3~12g、连翘6~16g。
上海市新型冠状病毒感染中医药诊疗专家共识(2022春季版),上海中医药杂志,2022,56(7):5-6.公开了荆银固表方治疗无症状感染者,该方剂是由金银花、荆芥、黄芪、防风、广藿香、板蓝根、桔梗、芦根、炒白术、生甘草。该文章是本申请人前期发表的,没有公开药物的剂量。Traditional Chinese Medicine JingYinGuBiao Formula TherapyImproves the Negative Conversion Rate ofSARS-CoV2 in Patients with MildCOVID-19.Int J Biol Sci.2022;18(15):5641–5652,该文章也是本申请人前期发表的,文章中公开了药物组成和用药剂量。但是本申请是发明人经过方药配伍严格遵循中医传统理论,是对前期公开组合物进行药味味数和剂量的优化,方中去掉了炒白术,桔梗和甘草的用量也发生了变化。优化后的组方严谨新颖,临床和实验研究结果表明该药物组合物对呼吸道传染病有确切的治疗效果,成本较低,无毒副作用、疗程短、显效快、治愈率高,愈后基本不复发。
【发明内容】
本发明的目的是针对现有技术中的不足,提供一种治疗呼吸道传染病的中药复方。
本发明的再一的目的是,提供一种上述药物的用途。
为实现上述目的,本发明采取的技术方案是:
一种治疗呼吸道传染病的中药复方,是由以下重量份的原料药制成:金银花7-11份,荆芥7-11份,黄芪10-14份,广藿香7-11份,防风7-11份,板蓝根7-11份,桔梗7-11份,芦根13-17份,甘草4-8份。
优选地,所述的中药组合物是由以下重量份的原料药制成:金银花8-10份,荆芥8-10份,黄芪11-13份,广藿香8-10份,防风8-10份,板蓝根8-10份,桔梗8-10份,芦根14-16份,甘草5-7份。
更优选地,所述的中药组合物是由以下重量份的原料药制成:金银花9份,荆芥9份,黄芪12份,广藿香9份,防风9份,板蓝根9份,桔梗9份,芦根15份,甘草6份。
优选地,所述的中药组合物的药剂是颗粒剂、汤剂、片剂、胶囊剂、口服液、合剂或糖浆剂。
为实现上述第二个目的,本发明采取的技术方案是:
如上任一所述的中药组合物在制备治疗呼吸道传染病药物中的应用。
本发明优点在于:
中药复方中金银花气味芳香,轻宣疏散,既能疏风解表,清热解毒,又能避秽化浊,为君药。荆芥辛而微温,解表散邪,助君药开皮毛以逐邪,并能清利上焦。黄芪甘温,内可补肺脾之气,益卫以固表,外可助荆、银疏散之力,扶正以祛邪。广藿香辛温芳香,外能发散表邪,内能化湿祛浊,辛散而不峻烈,微温而不燥热,具有芳香辟秽。荆芥、黄芪、广藿香共为臣药。防风甘缓微温而不峻,为风病之通用药,以祛风解表见长,与荆芥同用,增强疏散表邪之力。黄芪得防风,则固表而不留邪;防风得黄芪,则祛邪而不伤正。板蓝根功善解毒利咽散结,桔梗辛散苦泄,开宣肺气而利胸膈咽喉,共助清利上焦之功。芦根常与荆芥、银花等疏散风热药同用,外可清气分卫分邪热,内可除烦生津而无恋邪之弊。防风、板蓝根、桔梗、芦根共为佐药。甘草药性微寒,合桔梗清热利咽止痛,并可调和药性,为使药。以上诸药君臣分明、佐使得当,寒温并用,清补兼顾,肺卫同治,散中兼补,补中寓疏,相反相成,重在透散邪气,益卫固表,共奏疏风清热、扶正固表之功效。
【具体实施方式】
下面对本发明提供的具体实施方式作详细说明。
实施例1治疗呼吸道传染病的中药组合物(一)
金银花9份、荆芥9份、黄芪12份、广藿香9份、防风9份、板蓝根9份、桔梗9份、芦根15份、甘草6份。
实施例2治疗呼吸道传染病的中药组合物(二)
金银花9份、荆芥8份、黄芪13份、广藿香7份、防风11份、板蓝根9份、桔梗8份、芦根16份、甘草4份。
实施例3治疗呼吸道传染病的中药组合物(三)
金银花8份、荆芥10份、黄芪10份、广藿香11份、防风9份、板蓝根8份、桔梗10份、芦根13份、甘草8份。
实施例4治疗呼吸道传染病的中药组合物(四)
金银花10份、荆芥7份、黄芪14份、广藿香9份、防风8份、板蓝根10份、桔梗7份、芦根17份、甘草6份。
实施例5治疗呼吸道传染病的中药组合物(五)
金银花7份、荆芥11份、黄芪12份、广藿香8份、防风10份、板蓝根7份、桔梗11份、芦根15份、甘草5份。
实施例6治疗呼吸道传染病的中药组合物(六)
金银花11份、荆芥9份、黄芪11份、广藿香10份、防风7份、板蓝根11份、桔梗9份、芦根14份、甘草7份。
实施例7治疗呼吸道传染病的中药组合物(七)
金银花9份、荆芥10份、黄芪10份、广藿香11份、防风9份、板蓝根8份、桔梗10份、芦根13份、甘草8份。
实施例8治疗呼吸道传染病的中药组合物(八)
金银花8份、荆芥7份、黄芪14份、广藿香9份、防风8份、板蓝根10份、桔梗7份、芦根17份、甘草6份。
实施例9治疗呼吸道传染病的中药组合物(九)
金银花10份、荆芥11份、黄芪12份、广藿香8份、防风10份、板蓝根7份、桔梗11份、芦根15份、甘草5份。
实施例10治疗呼吸道传染病的中药组合物(十)
金银花7份、荆芥9份、黄芪11份、广藿香10份、防风7份、板蓝根11份、桔梗9份、芦根14份、甘草7份。
实施例11治疗呼吸道传染病的中药组合物(十一)
金银花11份、荆芥8份、黄芪13份、广藿香7份、防风11份、板蓝根9份、桔梗8份、芦根16份、甘草4份。
实施例12治疗呼吸道传染病的中药组合物片剂/胶囊的制备
取实施例1-11任一所述的中药组合物,加9-11倍量水,煎煮2-3.5小时,滤出药汁。再加9倍量水,煎煮2.5小时,滤出药汁,合并二次煎液,静置,滤取上清液,浓缩,放冷,加浓缩液3倍量酒精,搅拌沉淀过夜。取上清液,浓缩至稠浸膏;加入制药辅料,真空干燥,粉碎制粒,压制成片剂或填充装胶囊。
实施例13治疗呼吸道传染病的中药组合物颗粒的制备
取实施例1-11任一所述的中药组合物,加8-10倍量水,煎煮3小时,滤出药汁。再加10倍量水,煎煮2.5小时,滤出药汁,合并二次煎液,静置,滤取上清液,浓缩,放冷,加浓缩液2倍量酒精,搅拌沉淀过夜。取上清液,浓缩至稠浸膏;加适当制药辅料,制粒,干燥,整粒,分装15g/袋。
实施例14治疗呼吸道传染病的中药组合物合剂/口服液/糖浆剂的制备
取实施例1-11任一所述的中药组合物,加8-11倍量水,煎煮3小时,滤出药汁。再加8倍量水,煎煮3小时,滤出药汁,合并二次煎液,静置,滤取上清液,浓缩,放冷,加浓缩液3.5倍量酒精,搅拌沉淀过夜。取上清液,浓缩至稠浸膏;加适当制药辅料,制成合剂、口服液或糖浆剂。
实施例15动物实验
1.实验材料
1.1药物与试剂
治疗组一制备:金银花9份、荆芥9份、黄芪12份、广藿香9份、防风9份、板蓝根9份、桔梗9份、芦根15份、甘草6份;
治疗组二制备:金银花10份、荆芥7份、黄芪14份、广藿香9份、防风8份、板蓝根10份、桔梗7份、芦根17份、甘草6份;
对照组一制备:银花9份、荆芥9份、黄芪12份、广藿香9份、防风9份、板蓝根9份、桔梗6份、芦根15份、蜜麸炒白术9份、甘草片9份(优化前的复方);
对照组二制备:金银花10份、桂枝7份、黄芪14份、佩兰9份、防风8份、板蓝根10份、桔梗7份、知母17份、甘草6份;
空白组:生理盐水;
模型组:生理盐水。
1.2动物
60只BALB/c小鼠,雌雄各半,体重20±2g,购于上海西普尔-必凯实验动物有限公司。
1.3主要仪器与试剂
Heraleus-Fresco21微量冷冻离心机(德国Thermo Fisher科技公司);
SARS-COV-2蛋白(广州派真生物技术有限公司);小鼠IL-2ELISA试剂盒、小鼠TNF-αELISA试剂盒、小鼠IFN-γELISA试剂盒均购自上海酶联生物科技有限公司。
2.方法与结果
2.1分组
60只小鼠分组为模型组、治疗组一、治疗组二、对照组一、对照组二、空白组,每组10只。
2.2造模及给药
除空白组的10只小鼠外,其余50只小鼠进行鼻内接种SARS-CoV-2病毒,剂量为25μL/只。25℃下,8:00-20:00光照条件下维持一个明暗循环,以实验室标准饲料喂养,正常饮水,24h后观察小鼠症状,若有气促、呼吸困难烦躁和耸毛等症状说明造模成功。最后造模成功的小鼠有45只,分别为:治疗组一8只、治疗组二10只、对照组一9只、对照组二9只、模型组9只。评判模型成功的当天开始灌胃给药,治疗组和对照组小鼠按体重给药浓度为18mg/kg,给药体积为5ml/kg,模型组与空白组按照等体积的生理盐水灌胃,连续14d。给药结束后,眼球取血,4℃下静置过夜,3000r/min离心10min收集血清。操作遵循试剂盒操作说明书进行,计算血清中IL-2、IFN-γ、TNF-α的浓度。
2.3统计学方法
采用SPSS 25.0软件对数据进行统计处理。计量资料采用(x±s)表示,符合正态分布者采用t检验。
2.4结果
2.4.1各组小鼠血清中IL-2、IFN-γ、TNF-α的浓度
与空白组小鼠相比,模型组小鼠的1L-2、IFN-γ和TNF-α水平都显著升高;与模型组相比,治疗组与对照组的1L-2、IFN-γ和TNF-α的水平显著降低(p<0.01)、(p<0.05);与对照组比较,治疗组的1L-2、IFN-γ和TNF-α水平显著降低(p<0.05),见表1。
表1各组小鼠血清中TNF-α、IL-1β、IL-2含量比较
注:*与空白组比较,p<0.01;#与模型组相比,(p<0.01,p<0.05);&与对照组相比,p<0.05。
实施例16临床实验
1.资料与方法
1.1临床资料
本研究病例来自2022年4月6日至5月20日曙光医院新冠感染患者,共计393例;分为治疗组262例,对照组131例。
1.2诊断标准
西医诊断标准:新型冠状病毒无症状感染诊断参照《新型冠状病毒感染的肺炎诊疗方案(试行第九版)》、《新型冠状病毒感染的肺炎防控方案(第八版)》制定,新冠感染核酸检测阳性,其临床分型标准:
(一)轻型
临床症状轻微,影像学未见肺炎表现。
(二)普通型
具有上述临床表现,影像学可见肺炎表现。
(三)重型
成人符合下列任何一条:
1)出现气促,RR≥30次/分;
2)静息状态下,吸空气时指氧饱和度≤93%;
3)动脉血氧分压(PaO2)/吸氧浓度(FiO2)≤300mmHg(1mmHg=0.133kPa);
高海拔(海拔超过1000米)地区应根据以下公式对PaO2/FiO2进行校正:PaO2/FiO2×[760/大气压(mmHg)]。
4)临床症状进行性加重,肺部影像学显示24~48小时内病灶明显进展>50%者。
儿童符合下列任何一条:
1)持续高热超过3天;
2)出现气促(<2月龄,RR≥60次/分;2~12月龄,RR≥50次/分;1~5岁,RR≥40次/分;>5岁,RR≥30次/分),除外发热和哭闹的影响;
3)静息状态下,吸空气时指氧饱和度≤93%;
4)辅助呼吸(鼻翼扇动、三凹征);
5)出现嗜睡、惊厥;
6)拒食或喂养困难,有脱水征。
(四)危重型
符合以下情况之一者:
1)出现呼吸衰竭,且需要机械通气;
2)出现休克;
3)合并其他器官功能衰竭需ICU监护治疗。
1.3纳入标准
满足下列全部标准者方可入选:
(1)年龄18-65周岁(含18和65周岁),性别不限;
(2)有新冠感染密接、次密接标准,核酸检测结果为阳性,临床分型为轻型;
(3)自愿参加本试验并签署书面知情同意书。
1.4排除标准
满足下列标准中的任何一项即需排除:
(1)合并流感、其它肺炎、化脓性扁桃体炎、急性气管-支气管炎、肺结核、原发性纤毛运动障碍综合症、其它急性发作期的鼻腔疾病(如过敏性鼻炎、急慢性鼻炎、急慢性鼻窦炎等);
(2)本次病程内,就诊前已接受其它针对本病的内服药物如感冒药、抗病毒药、抗生素、中药等药物治疗;
(3)伴有急慢性腹泻等胃肠道不适症状;
(4)合并严重的心、脑、肺、肝、肾和血液系统等严重原发性疾病,如病毒性肝炎、血友病、控制不稳定/合并严重并发症的糖尿病、精神疾病等;
(5)妊娠或计划妊娠的女性,哺乳期妇女,试验期间不能或不愿意采取充分避孕的育龄期患者或其配偶不愿意采取避孕措施;
(6)过敏体质,如有对两种以上药物或食物过敏史,或已知对本研究药物各成份过敏;
(7)3个月内参加或正在参加其他药物临床试验;
(8)根据研究者的判断,具有降低入组可能性或使入组复杂化的其它病变或情况,如怀孕、工作环境经常变动、生活环境不稳定等易造成失访的情况。
1.5治疗方法
对照组:荆银固表优化方的十分之一剂量干预;
治疗组:荆银固表优化方干预。
1.6统计学处理
本研究数据采用SPSS 25.0软件进行统计分析。计数资料的描述采用频数和构成比,比较采用χ2检验。计量资料若符合正态分布,则组间比较采用两独立样本t检验,组内比较采用配对t检验;若不符合正态分布,则采用秩和检验。以P<0.05为差异具有统计学意义
1.7观察指标
(1)主要疗效指标:
新型冠状病毒核酸检测N基因和ORF基因Ct值变化。
分别在第0、3、6天,进行核酸检测。
采用荧光定量PCR方法测定新型冠状病毒核酸检测N基因和ORF基因Ct值,阴性:无Ct值或Ct值>40。阳性:Ct值<35。Ct值(cycle threshold)是指核酸检测Ct值,即pcr荧光信号达到阈值时所需的循环数。
根据Ct值定性判定核酸是否转阴并统计转阴率。
(2)次要疗效指标:
①转普通型率:由研究者统计试验期间的转为新冠感染普通型人数;
②平均核酸转阴时间:分别在第0、3、6天,进行核酸检测。
1.8临床疗效评估方法
核酸转阴率采用百分比表示,核酸转阴率=核酸转阴人数/同组总入组人数*100%。
2.结果
2.1各组用药3d、6d的核酸转阴率比较
荆银固表优化方用药后第3天,核酸转阴率显示:荆银固表优化方为34.7%、安慰剂对照组(荆银固表优化方的十分之一剂量)为19.8%,试验组与安慰剂对照组转阴率存在统计学差异(p<0.001)。在用药后第6天,核酸转阴率显示:荆银固表优化方为79.4%,安慰剂对照组(荆银固表优化方的十分之一剂量)为61.0%,试验组与安慰剂对照组转阴率存在统计学差异(p<0.001)。见表2、表3。
表2两组3d内核酸转阴率比较[例(%)]
表3两组6d内核酸转阴率比较[例(%)]
3.结论
干预1个疗程(6天)后,试验组患者的平均转阴时间中位数为4.89天,低于安慰剂对照组的6.31天(p<0.05),纳入观察病例无一转为重型。荆银固表优化方治疗新型冠状病毒轻型患者,可以缩短核酸转阴时间及加快出院时间。
以上所述仅是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员,在不脱离本发明方法的前提下,还可以做出若干改进和补充,这些改进和补充也应视为本发明的保护范围。
Claims (5)
1.一种治疗呼吸道传染病的中药复方,其特征在于,是由以下重量份的原料药制成:金银花7-11份,荆芥7-11份,黄芪10-14份,广藿香7-11份,防风7-11份,板蓝根7-11份,桔梗7-11份,芦根13-17份,甘草4-8份。
2.根据权利要求1所述的中药复方,其特征在于,是由以下重量份的原料药制成:金银花8-10份,荆芥8-10份,黄芪11-13份,广藿香8-10份,防风8-10份,板蓝根8-10份,桔梗8-10份,芦根14-16份,甘草5-7份。
3.根据权利要求2所述的中药复方,其特征在于,是由以下重量份的原料药制成:金银花9份,荆芥9份,黄芪12份,广藿香9份,防风9份,板蓝根9份,桔梗9份,芦根15份,甘草6份。
4.根据权利要求1-3任一所述的中药复方,其特征在于,所述的中药组合物的药剂是颗粒剂、汤剂、片剂、胶囊剂、口服液、合剂或糖浆剂。
5.权利要求1-3任一所述的中药复方在制备治疗呼吸道传染病药物中的应用。
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CHEN BOWU ET AL: "Traditional Chinese Medicine JingYinGuBiao Formula Therapy Improves the Negative Conversion Rate of SARS-CoV2 in Patients with Mild COVID-19", INTERNATIONAL JOURNAL OF BIOLOGICAL SCIENCES, vol. 18, no. 15, 1 September 2022 (2022-09-01), pages 4 - 5 * |
上海市新型冠状病毒感染中医药诊疗专家共识(2022春季版)编写组: "上海市新型冠状病毒感染中医药诊疗专家共识(2022春季版)", 上海中医药杂志, vol. 56, no. 07, 31 July 2022 (2022-07-31), pages 2 - 3 * |
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