CN114712452A - 一种中药组合物在制备抗sars病毒药物中的应用 - Google Patents
一种中药组合物在制备抗sars病毒药物中的应用 Download PDFInfo
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Abstract
本发明公开了一种中药组合物在制备抑制SARS病毒药物中的应用。本发明中药组合物主要由麻黄、石膏、连翘、黄芩、桑白皮、苦杏仁、前胡等药味组成,发挥复方中药的整体调节优势,具有多向性、多层面、多靶点的特点,经体内和体外实验证实能有效杀灭SARS病毒,效果显著。
Description
技术领域
本发明涉及一种中药组合物在制备抗病毒药物中的应用,特别是用于抗SARS病毒的应用,属于中草药领域。
背景技术
SARS病毒属于冠状病毒科( coronavirus) ,病毒粒子多呈圆形,有囊膜,外周有冠状排列的纤突,分布于细胞浆中,呈圆形,病毒直径在80~120nm之间。SARS病毒是冠状病毒的一个变种,是引起非典型肺炎的病原体。变种冠状病毒与流感病毒具有亲缘关系,但它是非常独特的一种冠状病毒,在2002年冬到2003年春肆虐全球的严重急性呼吸综合征(SARS、传染性非典型肺炎)的元凶就是这种冠状病毒。
SARS病毒在世界各地极为普遍。大约有15种不同冠状病毒株被发现,能够感染多种哺乳动物和鸟类,有些可使人发病。
SARS病毒引起的人类疾病主要是呼吸系统感染(包括严重急性呼吸综合症)。该病毒对温度很敏感,在33℃时生长良好,但35℃就使之受到抑制。由于这个特性,冬季和早春是该病毒疾病的流行季节。SARS病毒是成人普通感冒的主要病原之一,儿童感染率较高,主要是上呼吸道感染,一般很少波及下呼吸道。另外,还可引起婴儿和新生儿急性肠胃炎,主要症状是水样大便、发热、呕吐,每天可拉10余次,严重者甚至出现血水样便,极少数情况下也引起神经系统综合征。
病毒的生长多位于上皮细胞内,也可以感染肝脏、肾、心脏和眼睛,在另外的一些细胞类型(例如巨噬细胞)中也能生长。如今人类冠状病毒还没有合适的可作研究用的动物模型(人类疾病的动物模型(animal model of human disease)是指各种医学科学研究中建立的具有人类疾病模拟表现的动物。动物疾病模型主要用于实验生理学、实验病理学和实验治疗学(包括新药筛选)研究),因此对冠状病毒的分离工作难度很大,需用人肝脏细胞、气管及鼻黏膜细胞,经器官培养才能分离得到。增殖病毒也要用上述材料,亦很困难。
SARS病毒的血清型和抗原变异性还不明确。SARS病毒可以发生重复感染,表明其存在有多种血清型(至少有4种已知)并有抗原的变异,其免疫较困难。
冠状病毒科分为α、β、γ、δ属等4个属。α属冠状病毒包括人冠状病毒229E、长翼蝠冠状病毒1、猪流行性腹泻病毒等11种。β属冠状病毒包括鼠肝炎病毒、果蝠冠状病毒HKU9、严重急性呼吸综合征(SARS)相关病毒等9种。γ属冠状病毒包含禽冠状病毒和白鲸冠状病毒SW1两个种。δ属冠状病毒包含猪δ冠状病毒(PDCoV)。
一些冠状病毒感染后可造成人畜共患病。已知的人类冠状病毒共有七型,其中三种对我们人类的"杀伤力"巨大。这就是新冠病毒(2019-nCoV)、SARS(严重急性呼吸系统综合症)病毒、MERS(中东呼吸综合征病毒)。作为迄今最神秘的人类冠状病毒,SARS病毒还有许多秘密需要破解。
病毒性疫病作为一类具有高度传染性的疾病,目前尚缺乏理想的抗病毒药物,目前上市的抗病毒化学药物分为以下几类:
1. 穿入和脱壳抑制剂:金刚烷胺、金刚乙胺、恩夫韦地、马拉韦罗
2. DNA多聚酶抑制剂:阿昔洛韦、更昔洛韦、伐昔洛韦、泛昔洛韦、膦甲酸钠
3. 逆转录酶抑制剂:
核苷类:拉米夫定、齐多夫定、恩曲他滨、替诺福韦、阿德福韦酯
非核苷类:依法韦仑、奈韦拉平
4.蛋白质抑制剂:沙奎那韦
5.神经氨酸酶抑制剂:奥司他韦、扎那米韦
6.广谱抗病毒药:利巴韦林、干扰素
每一种抗病毒的化学药物的副作用也会有所不同,比如临床上比较常用的抗病毒药物利巴韦林在大剂量使用时,会出现心脏的损害,还会引起白细胞的减少导致可逆性的贫血。而中药因其独特的病毒病防治视角,成为近年来我国学者们研究的热点。研究显示,多种中药及其有效成分对病毒有一定的抑制作用。
本发明是在申请号为2008100894475的专利基础上进行的改进发明,在此全文引用该专利文件记载的内容。上述专利未公开该中药组合物有抗病毒的作用。申请号为202010153827.1号专利公开了本中药组合物具有抗流感病毒和抗新冠病毒的作用,但是并未公开本中药组合物具有抗SARS病毒的作用。
发明内容
本发明提供一种中药组合物制备抗SARS病毒药物中的应用,特别是抗SARS-CoV-2病毒的作用。该中药组合物由下列重量份的原料药制成:
麻黄52-86;石膏194-324;连翘194-324;黄芩78-130;桑白皮194-324;苦杏仁78-130; 前胡78-130; 半夏78-130; 陈皮78-130; 贝母78-130;牛蒡子78-130; 金银花78-130; 大黄39-65; 桔梗46-76; 甘草39-65。
本发明中药组合物的原料药的重量份比优选为:
麻黄52;石膏324;连翘194;黄芩78;桑白皮194;苦杏仁130;前胡78;半夏130;陈皮78;贝母78;牛蒡子130;金银花130;大黄39;桔梗76;甘草65。
本发明中药组合物的原料药的重量份比还优选为:
麻黄86;石膏194;连翘324;黄芩130;桑白皮324;苦杏仁78;前胡130;半夏78;陈皮130;贝母130; 牛蒡子78;金银花78 ;大黄65;桔梗46; 甘草39。
本发明中药组合物的原料药的重量份比还优选为:
麻黄69;石膏259;连翘259;黄芩104;桑白皮259;苦杏仁104;前胡104;半夏104;陈皮104;贝母104; 牛蒡子104;金银花104;大黄52;桔梗61;甘草52。
本发明中药组合物的原料药的重量份比还优选为:
麻黄55;石膏254;连翘318;黄芩107;桑白皮203;苦杏仁107;前胡82;半夏105;陈皮84;贝母125; 牛蒡子122;金银花113;大黄42;桔梗60; 甘草50。
本发明中药组合物中,所述苦杏仁为炒苦杏仁、贝母为浙贝母、金银花为山银花、半夏为清半夏。
本发明中药组合物主要由麻黄、石膏、连翘、黄芩、桑白皮等组成,发挥复方中药的整体调节优势,具有多向性、多层面、多靶点的特点,经实验证实能有效杀灭SARS病毒,效果显著。
本发明所述中药可以被有相同或相似功效的中药代替,并且这些药材均可以按照《全国中药炮制规范》或《中药大辞典》炮制。
本发明中药组合物的活性成分由以下步骤制成:
A、按组方比例称取浙贝母,粉碎成细粉,备用;
B、按组方比例称取麻黄、连翘、炒苦杏仁、清半夏、牛蒡子、大黄加40-70%乙醇回流提取2次,每次1-4小时,第一次加8-10倍量,第二次加6-9倍量,提取液合并,滤过,滤液减压回收乙醇,浓缩至60℃热测相对密度为1.14-1.16的清膏,备用;
C、按组方比例称取石膏、桑白皮、前胡、陈皮、山银花、桔梗、甘草,加水煎煮两次,每次1-4小时,第一次加9-11倍量,第二次加7-9倍量,煎液合并,滤过,浓缩至60℃热测相对密度为1.14-1.16的清膏,与步骤B所得的清膏合并,备用;
步骤A所得细粉和步骤C所得合并后的清膏共同构成该药物组合物的活性成分。
本发明药物的剂型为胶囊剂、片剂、散剂、颗粒剂、口服液、软胶囊、丸剂、酊剂、糖浆剂、栓剂、凝胶剂、喷雾剂或注射剂。
为使上述剂型能够实现,需在制备这些剂型时加入药学可接受的辅料,例如:填充剂、崩解剂、润滑剂、助悬剂、粘合剂、甜味剂、矫味剂、防腐剂、基质等。填充剂包括:淀粉、预胶化淀粉、乳糖、甘露醇、甲壳素、微晶纤维素、蔗糖等;崩解剂包括:淀粉、预胶化淀粉、微晶纤维素、羧甲基淀粉钠、交联聚乙烯吡咯烷酮、低取代羟丙纤维素、交联羧甲基纤维素钠等;润滑剂包括:硬脂酸镁、十二烷基硫酸钠、滑石粉、二氧化硅等;助悬剂包括:聚乙烯吡咯烷酮、微晶纤维素、蔗糖、琼脂、羟丙基甲基纤维素等;粘合剂包括,淀粉浆、聚乙烯吡咯烷酮、羟丙基甲基纤维素等;甜味剂包括:糖精钠、阿斯帕坦、蔗糖、甜蜜素、甘草次酸等;矫味剂包括:甜味剂及各种香精;防腐剂包括:尼泊金类、苯甲酸、苯甲酸钠、山梨酸及其盐类、苯扎溴铵、醋酸氯乙定、桉叶油等;基质包括:PEG6000,PEG4000,虫蜡等。
其中片剂由如下步骤制成:
A、按组方比例称取浙贝母,粉碎成细粉,备用;
B、按组方比例称取麻黄、连翘、炒苦杏仁、清半夏、牛蒡子、大黄加40-70%乙醇回流提取2次,每次1-4小时,第一次加8-10倍量,第二次加6-9倍量,提取液合并,滤过,滤液减压回收乙醇,浓缩至60℃热测相对密度为1.14-1.16的清膏,备用;
C、按组方比例称取石膏、桑白皮、前胡、陈皮、山银花、桔梗、甘草,加水煎煮两次,每次1-4小时,第一次加9-11倍量,第二次加7-9倍量,煎液合并,滤过,浓缩至60℃热测相对密度为1.14-1.16的清膏,与步骤B所得的清膏合并,备用;
D、将步骤C所得合并的清膏,喷雾干燥,收集喷雾粉备用;
E、步骤D所得喷雾粉与步骤A所得细粉,以乙醇为黏合剂制软材,过筛制粒;按药学常规方法压片即得。
优选的片剂的制备方法为:
A、按组方比例称取浙贝母,粉碎成细粉,备用;
B、按组方比例称取麻黄、连翘、炒苦杏仁、清半夏、牛蒡子、大黄加50%乙醇回流提取2次,每次3小时,第一次加10倍量,第二次加6倍量,提取液合并,滤过,滤液减压回收乙醇,浓缩至60℃热测相对密度为1.15的清膏,备用;
C、按组方比例称取石膏、桑白皮、前胡、陈皮、山银花、桔梗、甘草,加水煎煮两次,每次2小时,第一次加10倍量,第二次加7倍量,煎液合并,滤过,浓缩至60℃热测相对密度为1.15的清膏,与步骤B所得的清膏合并,备用;
D、将步骤C所得合并的清膏,喷雾干燥,收集喷雾粉备用;
E、步骤D所得喷雾粉与步骤A所得细粉,以乙醇为黏合剂制软材,过筛制粒干燥后整粒,加入羧甲淀粉钠、微晶纤维素、硬脂酸镁,混匀,压片即得。本发明药物其他剂型的制备方法为:按比例称取原料药,采用常规的制备方法制备,例如,范碧亭《中药药剂学》(上海科学出版社1997年12月第1版)记载的制备工艺,制成药剂学可接受的常规剂型。
本发明中药组合物可以抗SARS病毒,特别是SARS-CoV-2型病毒。
附图说明:
图1:肺组织病理改变,A模型组小鼠5天3号动物中度间质性肺炎H.E.X200 B本发明药物组小鼠5天1号动物轻度间质性肺炎H.E.X200 C本发明药物组小鼠5天2号动物中度间质性肺炎H.E.X200。
具体实施方式
下述实施例用于举例说明本发明药物的制备,但其不能对本发明的范围构成任何限制。
实施例1
处方:
麻黄52克;石膏324克;连翘194克;黄芩78克;桑白皮194克;苦杏仁130克;前胡78克;半夏130克;陈皮78克;浙贝母78克;牛蒡子130克;山银花130克;大黄39克;桔梗76克;甘草65克。
制备方法:
A、按组方比例称取浙贝母,粉碎成细粉,备用;
B、按组方比例称取麻黄、连翘、苦杏仁、半夏、牛蒡子、大黄加50%乙醇回流提取2次,每次3小时,第一次加10倍量,第二次加6倍量,提取液合并,滤过,滤液减压回收乙醇,浓缩至60℃热测相对密度为1.15的清膏,备用;
C、按组方比例称取石膏、桑白皮、前胡、陈皮、山银花、桔梗、甘草,加水煎煮两次,每次2小时,第一次加10倍量,第二次加7倍量,煎液合并,滤过,浓缩至60℃热测相对密度为1.15的清膏,与步骤B所得的清膏合并,备用;
D、将步骤C所得合并的清膏,喷雾干燥,收集喷雾粉备用;
E、步骤D所得喷雾粉,步骤A所得细粉,以80%乙醇为黏合剂制备软材,过筛制粒,60度干燥后,整粒。加入羧甲基淀粉钠、微晶纤维素、硬脂酸镁混匀,按常规制剂方法制成片剂,即得。
实施例2
处方:
麻黄86克;石膏194克;连翘324克;黄芩130克;桑白皮324克;炒苦杏仁78克;前胡130克;半夏78克;陈皮130克;贝母130克; 牛蒡子78克;山银花78克 ;大黄65克;桔梗46克;甘草39克。
制备方法:
A、按组方比例称取贝母,粉碎成细粉,备用;
B、按组方比例称取麻黄、连翘、炒苦杏仁、半夏、牛蒡子、大黄加40%乙醇回流提取2次,每次4小时,第一次加8倍量,第二次加9倍量,提取液合并,滤过,滤液减压回收乙醇,浓缩至60℃热测相对密度为1.14的清膏,备用;
C、按组方比例称取石膏、桑白皮、前胡、陈皮、山银花、桔梗、甘草,加水煎煮两次,每次4小时,第一次加9倍量,第二次加7倍量,煎液合并,滤过,浓缩至60℃热测相对密度为1.16的清膏,与步骤B所得的清膏合并,备用;
D、将步骤C所得合并的清膏,喷雾干燥,收集喷雾粉备用;
E、步骤D所得喷雾粉,步骤A所得细粉,以80%乙醇为黏合剂制备软材,过筛制粒,60度干燥后,整粒。加入羧甲基淀粉钠、微晶纤维素、硬脂酸镁混匀,按常规制剂方法制成片剂,即得。
实施例3
处方:
麻黄69克;石膏259克;连翘259克;黄芩104克;桑白皮259克;炒苦杏仁104克;前胡104克;清半夏104克;陈皮104克;浙贝母104克; 牛蒡子104克;山银花104克;大黄52克;桔梗61克;甘草52克。
制备方法:
A、按组方比例称取浙贝母,粉碎成细粉,备用;
B、按组方比例称取麻黄、连翘、炒苦杏仁、清半夏、牛蒡子、大黄加70%乙醇回流提取2次,每次1小时,第一次加10倍量,第二次加6倍量,提取液合并,滤过,滤液减压回收乙醇,浓缩至60℃热测相对密度为1.16的清膏,备用;
C、按组方比例称取石膏、桑白皮、前胡、陈皮、山银花、桔梗、甘草,加水煎煮两次,每次1小时,第一次加11倍量,第二次加7倍量,煎液合并,滤过,浓缩至60℃热测相对密度为1.14的清膏,与步骤B所得的清膏合并,备用;
D、将步骤C所得合并的清膏,喷雾干燥,收集喷雾粉备用;
E、步骤D所得喷雾粉,步骤A所得细粉,以80%乙醇为黏合剂制备软材,过筛制粒,60度干燥后,整粒。加入羧甲基淀粉钠、微晶纤维素、硬脂酸镁混匀,按常规制剂方法制成片剂,即得。
实施例4:
原料药配方为:
麻黄55克;石膏254克;连翘318克;黄芩107克;桑白皮203克;炒苦杏仁107克;前胡82克;半夏105克;陈皮84克;浙贝母125克; 牛蒡子122克;山银花113克;大黄42克;桔梗60克; 甘草50克。
制备方法:
A、按组方比例称取浙贝母,粉碎成细粉,备用;
B、按组方比例称取麻黄、连翘、炒苦杏仁、半夏、牛蒡子、大黄加60%乙醇回流提取2次,每次2小时,第一次加9倍量,第二次加7倍量,提取液合并,滤过,滤液减压回收乙醇,浓缩至60℃热测相对密度为1.15的清膏,备用;
C、按组方比例称取石膏、桑白皮、前胡、陈皮、山银花、桔梗、甘草,加水煎煮两次,每次2.5小时,第一次加10倍量,第二次加7倍量,煎液合并,滤过,浓缩至60℃热测相对密度为1.14的清膏,与步骤B所得的清膏合并,备用;
D、将步骤C所得合并的清膏,喷雾干燥,收集喷雾粉备用;
E、步骤D所得喷雾粉,步骤A所得细粉,以80%乙醇为黏合剂制备软材,过筛制粒,60度干燥后,整粒。加入羧甲基淀粉钠、微晶纤维素、硬脂酸镁混匀,按常规制剂方法制成片剂,即得。
实施例5:
麻黄62克 石膏220克 连翘256克 黄芩90克 桑白皮300克
苦杏仁90克 前胡90克 半夏90克 陈皮100克 贝母100克 牛蒡子100克 金银花100克 大黄50克 桔梗66克 甘草50克
以上药材,按常规方法制成胶囊剂即得。
实施例6:
麻黄68克 石膏215克 连翘215克 黄芩100克 桑白皮220克
苦杏仁90克 前胡90克 半夏90克 陈皮90克 贝母90克
牛蒡子90克 金银花90克 大黄50克 桔梗50克 甘草50克
以上药材,按常规方法制成颗粒剂即得。
实施例7:
麻黄50克 石膏200克 连翘300克 黄芩100克 桑白皮250克
苦杏仁100克 前胡100克 半夏100克 陈皮100克 贝母100克
牛蒡子100克 金银花100克 大黄50克 桔梗50克 甘草50克
以上药材,按常规方法制成注射剂即得。
实施例8:
麻黄60克 石膏200克 连翘200克 黄芩95克 桑白皮230克
苦杏仁95克 前胡95克 半夏95克 陈皮95克 贝母95克
牛蒡子95克 金银花95克 大黄50克 桔梗50克 甘草50克
以上药材,按常规方法制成丸剂即得。
实验例:
为证实本发明中药组合物具有抗SARS病毒的疗效,用按本发明药物组合物实施例3制备方法,压片前的颗粒作为供试品(以下称本发明药物),委托中国医学科学院医学实验动物研究所进行了以下药理试验研究:
本发明药物组合物治疗SARS-CoV-2感染小鼠试验研究
1、药品与试剂:
受试药本发明药物组合物:由石家庄以岭药业股份有限公司提供。试验所用为本发明药物组合物颗粒,批号为:A1911001,本品性状为棕黄色粉末,每克颗粒相当于4.095克生药,申请人配置好受试药品,360mg/ml。
2、攻毒毒株:SARS-CoV-2;感染途径:滴鼻;
感染剂量:105TCID50/只;感染体积:50微升
3、实验动物:HACE2转基因小鼠,SPF级别,动物年龄为10-12周龄,动物体重:20-24g,动物来源:中国医学科学院医学实验动物研究所
4、方法与结果
动物分组:分为本发明药物组合物组和模型组
每组动物数量:6只
给药剂量:360mg/ml,按照体积1ml/100g体重给予,最终给药剂量本发明药物组合物14.67生药/Kg/d,为临床拟用量的40倍。
给药途径:灌胃
给药时间:攻毒后1小时给药,每天1次,连续给药5天,模型组按照等体积给予蒸馏水。
5、观察指标
小鼠攻毒后连续观察5天,记录体重变化。感染后第5天,小鼠全部安乐死,3只检测肺组织病毒载量,3只进行肺组织病理学检查。
6数据统计处理方法
本实验所产生的定量数据,应用统计处理软件SPSS(Version.17.0)进行方差分析。
7、实验结果
7.1药物抗病毒效果
7.1.1实验结果
动物临床表现:模型组小鼠感染后出现体重下降,平均下降百分比最高为5.41%。与模型组比较,本发明药物组合物组感染后第3天体重升高,至第5天平均升高4.55%。其他一般状态良好,显示出给予本发明药物组合物组小鼠症状有一定程度缓解。结果见表2。
病毒载量:
模型组小鼠感染后5天,肺组织平均病毒载量检测结果为105.97copies/ml。本发明药物组合物组小鼠感染后5天肺组织平均病毒载量为105.26copies/ml,显著低于模型组。给予本发明药物组合物组病毒载量下降0.72 lg值,见表3。
各组受试物小鼠体重下降率与模型组比较,*P<0.05有显著差异
3病理诊断
SARS-CoV-2感染5天的hACE2转基因模型组小鼠3例(3/3)肺组织呈中度间质性肺炎改变,可见肺泡隔明显增宽,炎细胞浸润,血管周围少量炎细胞浸润,肺泡腔内少量炎细胞及浆液渗出。
本发明药物组合物组小鼠2例(2/3)肺组织呈中度间质性肺炎改变,可见肺泡隔明显增宽,炎细胞浸润,血管周围少量炎细胞浸润;1例(1/3)肺组织呈轻度间质性肺炎改变,可见肺泡隔轻度增宽,炎细胞浸润,血管周围少量炎细胞浸润,见表4。与模型组相比,本发明药物组合物组肺组织病变有改善。
附:病变分级标准:
1肺泡隔增宽:
+,轻度病变,肺泡隔轻度增宽。
++,中度病变,肺泡隔明显增宽,病变范围大于1/2。
+++,重度病变,肺泡隔明显增宽,并出现肺泡隔增宽、融合、肺泡腔明显缩窄,病变范围大于1/2。
++++,极重度病变,肺泡隔增宽、融合、肺泡腔明显缩窄以至消失,局部肺组织实变,病变范围大于3/4。
2其他病变(肺泡内渗出、血管周围炎细胞浸润等)
+,轻度病变,病变范围小于肺组织切面1/4。
++,中度病变,病变范围约占肺组织切面1/4-2/4。
+++,重度病变,病变范围约占肺组织切面2/4-3/4。
++++,极重度病变,病变范围大于肺组织切面3/4。
结论:模型组小鼠体重下降5.41%,肺组织病毒载量为105.97copies/ml,肺组织呈中度间质性肺炎改变。
本发明药物组合物组与模型组相比,感染后体重升高4.55%,症状有明显改善,肺组织病毒载量为105.26copies/ml,下降0.72 lg值,肺组织病变有改善。
Claims (11)
1.一种中药组合物在制备抗SARS病毒药物中的应用,其特征在于所述中药组合物由下列重量份的原料药制成:
麻黄52-86 ;石膏194-324; 连翘194-324 ;黄芩78-130 ;桑白皮194-324;苦杏仁78-130; 前胡78-130; 半夏78-130; 陈皮78-130; 贝母78-130; 牛蒡子78-130; 金银花78-130; 大黄39-65; 桔梗46-76; 甘草39-65。
2.根据权利要求1所述的应用,其特征在于由下列重量份的原料药制成:
麻黄52; 石膏 324; 连翘194; 黄芩78; 桑白皮194; 苦杏仁130; 前胡78; 半夏130;陈皮78; 贝母78; 牛蒡子130; 金银花130; 大黄39; 桔梗76; 甘草65。
3.根据权利要求1所述的应用,其特征在于由下列重量份的原料药制成:
麻黄86;石膏194;连翘324;黄芩130;桑白皮324;苦杏仁78;前胡130;半夏78;陈皮130;贝母130; 牛蒡子78;金银花78 ;大黄65;桔梗46; 甘草39。
4.根据权利要求1所述的应用,其特征在于由下列重量份的原料药制成:
麻黄69;石膏259;连翘259;黄芩104;桑白皮259;苦杏仁104;前胡104;半夏104;陈皮104;贝母104; 牛蒡子104;金银花104;大黄52;桔梗61;甘草52。
5.根据权利要求1所述的应用,其特征在于由下列重量份的原料药制成:
麻黄55;石膏254;连翘318;黄芩107;桑白皮203;苦杏仁107;前胡82;半夏105;陈皮84;贝母125; 牛蒡子122;金银花113;大黄42;桔梗60; 甘草50。
6.根据权利要求1-5任一项所述的应用,其特征在于所述苦杏仁为炒苦杏仁、贝母为浙贝母、金银花为山银花、半夏为清半夏。
7.根据权利要求1-5任一项所述的应用,其特征在于所述药物的活性成分由以下步骤制成:
A、按组方比例称取贝母,粉碎成细粉,备用;
B、按组方比例称取麻黄、连翘、苦杏仁、半夏、牛蒡子、大黄加40-70%乙醇回流提取2次,每次1-4小时,第一次加8-10倍量,第二次加6-9倍量,提取液合并,滤过,滤液减压回收乙醇,浓缩至60℃热测相对密度为1.14-1.16的清膏,备用;
C、按组方比例称取石膏、桑白皮、前胡、陈皮、金银花、桔梗、甘草,加水煎煮两次,每次1-4小时,第一次加9-11倍量,第二次加7-9倍量,煎液合并,滤过,浓缩至60℃热测相对密度为1.14-1.16的清膏,与步骤B所得的清膏合并,备用;
步骤A所得细粉和步骤C所得合并后的清膏共同构成该药物组合物的活性成分。
8.根据权利要求1-5任一项所述的应用,其特征在于所述药物剂型为片剂、胶囊剂、散剂、颗粒剂、口服液、丸剂、酊剂、糖浆剂、栓剂、凝胶剂、喷雾剂或注射剂。
9.根据权利要求8所述的应用,其特征在于所述片剂由以下步骤制成:
A、按组方比例称取贝母,粉碎成细粉,备用;
B、按组方比例称取麻黄、连翘、苦杏仁、半夏、牛蒡子、大黄加40-70%乙醇回流提取2次,每次1-4小时,第一次加8-10倍量,第二次加6-9倍量,提取液合并,滤过,滤液减压回收乙醇,浓缩至60℃热测相对密度为1.14-1.16的清膏,备用;
C、按组方比例称取石膏、桑白皮、前胡、陈皮、金银花、桔梗、甘草,加水煎煮两次,每次1-4小时,第一次加9-11倍量,第二次加7-9倍量,煎液合并,滤过,浓缩至60℃热测相对密度为1.14-1.16的清膏,与步骤B所得的清膏合并,备用;
D、将步骤C所得合并的清膏,喷雾干燥,收集喷雾粉备用;
E、步骤D所得喷雾粉与步骤A所得细粉,以乙醇为黏合剂制软材,过筛制粒;按药学常规方法压片即得。
10.根据权利要求9所述的应用,其特征在于所述片剂由以下步骤制成:
A、按组方比例称取贝母,粉碎成细粉,备用;
B、按组方比例称取麻黄、连翘、苦杏仁、半夏、牛蒡子、大黄加50%乙醇回流提取2次,每次3小时,第一次加10倍量,第二次加6倍量,提取液合并,滤过,滤液减压回收乙醇,浓缩至60℃热测相对密度为1.15的清膏,备用;
C、按组方比例称取石膏、桑白皮、前胡、陈皮、金银花、桔梗、甘草,加水煎煮两次,每次2小时,第一次加10倍量,第二次加7倍量,煎液合并,滤过,浓缩至60℃热测相对密度为1.15的清膏,与步骤B所得的清膏合并,备用;
D、将步骤C所得合并的清膏,喷雾干燥,收集喷雾粉备用;
E、步骤D所得喷雾粉与步骤A所得细粉,以乙醇为黏合剂制软材,过筛制粒干燥后整粒,加入羧甲淀粉钠、微晶纤维素、硬脂酸镁,混匀,压片即得。
11.根据权利要求1-5任一项所述的应用,其特征在于该中药组合物在制备抗SARS-CoV-2病毒药物中的应用。
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