CN112138133B - 一种治疗新型冠状病毒肺炎的药物组合物及其制备方法和用途 - Google Patents
一种治疗新型冠状病毒肺炎的药物组合物及其制备方法和用途 Download PDFInfo
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Abstract
本发明涉及一种治疗新型冠状病毒肺炎的药物组合物及其制备方法和用途。该药物组合物是由桃仁、红花、三棱、莪术、红景天等17味原料药组成的药物组合物。该药物组合物对新型冠状病毒肺炎具有很好的治疗效果,能够抑制新型冠状病毒肺炎普通型转重型/危重型的趋势,服用本发明的药物组合物后,重型/危重型患者治愈出院率高达79.7%,总治愈出院率高达80.1%。本发明的药物组合物还能够缩短患者发热病程,缩短患者住院天数,降低总体费用。本发明的药物组合物在制备治疗新型冠状病毒肺炎的药物中具有非常好的应用前景。
Description
技术领域
本发明属于药物领域,具体涉及一种治疗新型冠状病毒肺炎的药物组合物及其制备方法和用途。
背景技术
新型冠状病毒肺炎,简称“新冠肺炎”, 是一类新型病毒肺炎,目前已成全球流行趋势,被列为全球突发的公共卫生事件。新型冠状病毒肺炎传染性极强,人群普遍易感。
目前针对新型冠状病毒肺炎,推荐使用的药物有洛匹那韦/利托那韦(成人200mg/50mg/粒,每次2粒,每日2次),或磷酸氯喹(18岁-65岁成人,体重大于50公斤者,每次500mg,每日2次;体重小于50公斤者,第一二天每次500mg,每日2次,第三日至第七天,每次500mg,每日1次),或阿比多尔(成人200mg,每日3次)。但是,这些药物治疗有效率低,死亡率高;而且副作用大,致使临床应用受限。
新型冠状病毒肺炎属于中医“疫病”、“瘟疫”范畴,而中医药防治疫病已有数千年的历史,且取得了很好的疗效,尤其是在2003年的SARS防治中,中医药再次发挥了巨大作用。 因此,亟需研究出一种能够有效治疗新型冠状病毒肺炎的中药组合物。
发明内容
本发明的目的在于提供一种治疗新型冠状病毒肺炎的药物组合物及其制备方法和用途。
本发明提供了一种药物组合物,所述药物组合物是由下述重量配比的原料药组成的:麻黄2~4份,杏仁3~5份,生石膏7~9份,炙甘草5~7份,地龙5~7份,北五味7~9份,制附片3~5份,生姜2~4份,白术7~9份,白芍9~11份,茯苓9~11份,人参2~4份,桃仁5~7份,红花5~7份,三棱5~7份,莪术5~7份,红景天9-11份。
进一步地,所述药物组合物是由下述重量配比的原料药组成的:麻黄3份,杏仁4份,生石膏8份,炙甘草6份,地龙6份,北五味8份,制附片4份,生姜3份,白术8份,白芍10份,茯苓10份,人参3份,桃仁6份,红花6份,三棱6份,莪术6份,红景天10份。
本发明还提供了一种治疗新型冠状病毒肺炎的药物,所述药物是以上述的药物组合物为活性成分,加上药学上可接受的辅料制成的制剂。
进一步地,所述制剂为口服剂。
进一步地,所述口服剂为滴丸剂、软胶囊剂、汤剂、口服液、颗粒剂、散剂或片剂。
本发明还提供了一种制备上述药物组合物的方法,所述方法包括以下步骤:按重量配比称取原料药,打粉,混合均匀,即得。
本发明还提供了另一种制备上述药物组合物的方法,所述方法包括以下步骤:
(1)取生石膏、制附片,煎制;
(2)将除生石膏、制附片之外的其余所有原料药在水中浸泡,然后将浸泡后的原料药和水加入步骤(1)所得体系中,加热煎煮,过滤;在滤渣中再次加入水,加热煎煮,过滤;合并滤液,浓缩或干燥,即得。
进一步地,步骤(1)中,所述煎制时间为20~40min,优选为30min。
进一步地,步骤(2)中,所述浸泡时加入的水与麻黄的体积重量比为(400~600):1ml/g,优选为500:1 ml/g;所述再次加入的水与浸泡时加入的水的体积比为3:(2~3);所述浸泡时间为20~40min,优选为30min;所述加热煎煮的条件为:在水烧开的条件下煎煮20~30min。
本发明还提供了上述药物组合物在制备治疗新型冠状病毒肺炎的药物中的用途。
本发明中,“熟地”即熟地黄;“炙甘草”为甘草的炮制加工品,制法同中国药典中记载一致;“生石膏”为石膏生用; “北五味”为主产于东北的木兰科多年生落叶木质藤本植物五味子的成熟果实;“制附片”为白附子的炮制加工品,制法同中国药典中记载一致。
新型冠状病毒属于中医 “疫病”、“瘟疫”范畴,正如《素问·刺法论》中讲:“五疫之至,皆相染易,无问大小,病状相似。”“避其毒气,天牝从来。”因此,新型冠状病毒肺炎是病位在肺的疫病,温热浊毒、痰瘀互结为其病理因素。故本病的治疗首当清肺平踹,恢复肺的升降功能,化痰解毒、活血化瘀,清除病理产物,其次更重要的是恢复气血阴阳的平和。正如《黄帝内经》所言:“谨守病机,各司其属,...,令其条达,以致平和”。
本发明提供的药物组合物能够抑制新型冠状病毒肺炎普通型转重型/危重型的趋势,服用本发明的药物组合物后,重型/危重型患者治愈出院率高达79.7%,总治愈出院率高达80.1%。本发明的药物组合物还能够缩短患者发热病程,缩短患者住院天数,降低总体费用。本发明的药物组合物在制备治疗新型冠状病毒肺炎的药物中具有非常好的应用前景。
本发明药物组合物的制备工艺简单,适合工业生产。
显然,根据本发明的上述内容,按照本领域的普通技术知识和惯用手段,在不脱离本发明上述基本技术思想前提下,还可以做出其它多种形式的修改、替换或变更。
以下通过实施例形式的具体实施方式,对本发明的上述内容再作进一步的详细说明。但不应将此理解为本发明上述主题的范围仅限于以下的实例。凡基于本发明上述内容所实现的技术均属于本发明的范围。
具体实施方式
本发明所用原料与设备均为已知产品,通过购买市售产品所得。
实施例1、本发明药物组合物的制备
组方:麻黄3克,杏仁4克,生石膏8克,炙甘草6克,地龙6克,北五味8克,制附片4克,生姜3克,白术8克,白芍10克,茯苓10克,人参3克,桃仁6克,红花6克,三棱6克,莪术6克,红景天10克。
工艺:
(1)预处理:按重量配比称取生石膏、制附片,先煎制30min;
(2)将组方中除生石膏、制附片之外的其余所有原料药在1500ml水中浸泡30min,然后将浸泡后的原料药和水一起加入步骤(1)所得体系中,大火烧开,煎煮20min,过滤;在药渣中再加入1000ml水,大火烧开,继续煎煮30min,过滤;合并2次的滤液,浓缩至450ml,即得本发明药物组合物。
实施例2、本发明药物组合物的制备
组方:麻黄2克,杏仁3克,生石膏7克,炙甘草5克,地龙5克,北五味7克,制附片3克,生姜2克,白术7克,白芍9克,茯苓9克,人参2克,桃仁5克,红花5克,三棱5克,莪术5克,红景天9克。
工艺:同实施例1。
实施例3、本发明药物组合物的制备
组方:麻黄4克,杏仁5克,生石膏9克,炙甘草7克,地龙7克,北五味9克,制附片5克,生姜4克,白术9克,白芍11克,茯苓11克,人参4克,桃仁7克,红花7克,三棱7克,莪术7克,红景天11克。
工艺:同实施例1。
实施例4、本发明滴丸剂的制备
以实施例1制得的药物组合物为活性成分,加上药学上可接受的辅料,制备成本发明的滴丸剂。
实施例5、本发明软胶囊剂的制备
以实施例1制得的药物组合物为活性成分,加上药学上可接受的辅料,制备成本发明的软胶囊剂。
以下通过实验例证明本发明药物组合物的有益效果。
实验例1、本发明药物组合物对新型冠状病毒肺炎的治疗效果
1、新型冠状病毒肺炎的收治标准
普通型: 新型冠状病毒肺炎患者具有发热、呼吸道症状等临床症状,影像学可见肺炎表现。
重型:新型冠状病毒肺炎患者符合下列任何一条: 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。
危重型:新型冠状病毒肺炎患者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。
中医标准:痰瘀互结、肺失宣肃证,证见发热、干咳少痰、呼吸困难,甚或紫绀,舌淡(或青紫)苔白,脉浮紧等。
共收治176例患者,其中,普通型112例,重症/危重症64例。
2、实验药物
本发明实施例1制得的药物组合物。
给药方式:取实施例1浓缩后制得的药物组合物,口服,150ml/次,3次/日。疗程为2周。
3、疗效评价
出院标准:1.体温恢复正常3天以上;2.呼吸道症状明显好转;3.肺部影像学显示急性渗出性病变明显改善;4.连续两次呼吸道标本核酸检测阴性(采样时间至少间隔24小时)。
普通型转重型/危重型率 =(普通型患者转变为重型/危重型患者的数量)/总的普通型患者数量 ×100%
重型/危重型治愈出院率 = 重型/危重型治愈出院患者数量/总的重型/危重型患者数量×100%
总治愈出院率 = 总的治愈出院患者数量/总患者数量×100%。
4、实验结果
表1 药物对新型冠状病毒肺炎的治疗效果
收治普通型患者数 | 收治重型/危重型患者数 | 普通型转重症/危重型率 | 重型/危重型治愈出院率 | 总治愈出院率 |
112 | 64 | 0% | 79.7% | 80.1% |
备注:因统一部署,在没有计算入总治愈出院率的患者中有31例患者因腾退病区转院。
结果如表1所示。 本发明提供的药物组合物对收治的176例新型冠状病毒肺炎患者取得了很好的疗效,本发明的药物组合物能够抑制新型冠状病毒肺炎普通型转重型/危重型的趋势,服用本发明的药物组合物后,重型/危重型患者治愈出院率高达79.7%,总治愈出院率高达80.1%。本发明的药物组合物还能够缩短患者发热病程,缩短患者住院天数,降低总体费用。
综上,本发明提供了一种由桃仁、红花、三棱、莪术、红景天等17味原料药组成的药物组合物。该药物组合物能够抑制新型冠状病毒肺炎普通型转重型/危重型的趋势,服用本发明的药物组合物后,重型/危重型患者治愈出院率高达79.7%,总治愈出院率高达80.1%。本发明的药物组合物还能够缩短患者发热病程,缩短患者住院天数,降低总体费用。本发明的药物组合物在制备治疗新型冠状病毒肺炎的药物中具有非常好的应用前景。
Claims (12)
1.一种治疗新型冠状病毒肺炎的药物组合物,其特征在于:所述药物组合物是由下述重量配比的原料药组成的:麻黄2~4份,杏仁3~5份,生石膏7~9份,炙甘草5~7份,地龙5~7份,北五味7~9份,制附片3~5份,生姜2~4份,白术7~9份,白芍9~11份,茯苓9~11份,人参2~4份,桃仁5~7份,红花5~7份,三棱5~7份,莪术5~7份,红景天9-11份。
2.根据权利要求1所述的药物组合物,其特征在于:所述药物组合物是由下述重量配比的原料药组成的:麻黄3份,杏仁4份,生石膏8份,炙甘草6份,地龙6份,北五味8份,制附片4份,生姜3份,白术8份,白芍10份,茯苓10份,人参3份,桃仁6份,红花6份,三棱6份,莪术6份,红景天10份。
3.一种治疗新型冠状病毒肺炎的药物,其特征在于:所述药物是以权利要求1~2任一项所述的药物组合物为活性成分,加上药学上可接受的辅料制成的制剂。
4.根据权利要求3所述的药物,其特征在于:所述制剂为口服剂。
5.根据权利要求4所述的药物,其特征在于:所述口服剂为滴丸剂、软胶囊剂、汤剂、口服液、颗粒剂、散剂或片剂。
6.一种制备权利要求1~2任一项所述药物组合物的方法,其特征在于:所述方法包括以下步骤:按重量配比称取原料药,打粉,混合均匀,即得。
7.一种制备权利要求1~2任一项所述药物组合物的方法,其特征在于:所述方法包括以下步骤:
(1)取生石膏、制附片,煎制;
(2)将除生石膏、制附片之外的其余所有原料药在水中浸泡,然后将浸泡后的原料药和水加入步骤(1)所得体系中,加热煎煮,过滤;在滤渣中再次加入水,加热煎煮,过滤;合并滤液,浓缩或干燥,即得。
8.根据权利要求7所述的方法,其特征在于:步骤(1)中,所述煎制时间为20~40min。
9.根据权利要求8所述的方法,其特征在于:步骤(1)中,所述煎制时间为30min。
10.根据权利要求7~9任一项所述的方法,其特征在于:步骤(2)中,所述浸泡时加入的水与麻黄的体积重量比为(400~600):1 ml/g;所述再次加入的水与浸泡时加入的水的体积比为3:(2~3);所述浸泡时间为20~40min;所述加热煎煮的条件为:在水烧开的条件下煎煮20~30min。
11.根据权利要求10所述的方法,其特征在于:步骤(2)中,所述浸泡时加入的水与麻黄的体积重量比为500:1 ml/g;所述浸泡时间为30min。
12.权利要求1~2任一项所述药物组合物在制备治疗新型冠状病毒肺炎的药物中的用途。
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