CN111773331A - 一种用于治疗疑似新冠肺炎的中药组合物及其制备与应用 - Google Patents
一种用于治疗疑似新冠肺炎的中药组合物及其制备与应用 Download PDFInfo
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Abstract
本发明公开了一种用于治疗疑似新冠肺炎的中药组合物及其制备与应用,所述中药组合物由如下质量配比的原料制成:金银花10~20份、连翘10~30份、荆芥10~20份、黄芩10~20份、大青叶10~20份、羌活10~20份、薄荷5~10份、牛蒡子10~30份、蝉衣5~10份、僵蚕10~20份、鲜芦根10~30份、紫草10~30份、生甘草5~20份。本发明中药组合物可明显改善新冠肺炎疑似患者的呼吸道症状,缩短隔离天数,减少并发症。且本发明中药组合物是在中医理论指导下,以清热化痰为治疗原则选药组方,中药材治疗无明显毒副作用可长服用,适用范围广。
Description
(一)技术领域
本发明涉及一种用于治疗疑似新冠肺炎的中药组合物及其制备与应用。
(二)背景技术
2019年12月以来,已知可感染人类的冠状病毒只有六种,其中只有SARS-CoV、MERS-CoV两种可一起致命的肺炎,另外四种HcoV-229E、HcoV-NL63、HcoV-HKU1、 HcoV-OC43冠状病毒仅能引起轻症呼吸道感染。此次新型冠状病毒肺炎似乎可以引起 与SARS类似症状,最近Lancet发布的来自中国的一项临床研究表明,41例实验室确诊 的2019-nCoV感染患者,1/3需要重症监护,6例死亡,5例有急性心脏损伤,且同时发 表的后一项研究报告了一个六口之家的临床及微生物学数据,证实了人际传播的可 能。疫情形势严峻,且目前传播途径尚未知,尚无特效治疗药物,鉴于此前2003年SARS 流行期间的实战经验,目前更是需要发挥中国传统医学的在疫情预防及治疗过程中的 独特优势。
吸道病毒引起的呼吸道感染具有季节性、流行性、传染性等特点,中医将其归属于“温病”范畴,按照不同的季节可有“湿温”、“春温”、“风温”、“冬温”等不同称 呼。在几千年的临床实践中,古代医家对时令病的治疗积累了不少宝贵的经验。早在 《素问·刺法论》中就提到“避其毒邪”。强调了对瘟疫要未病先防的思想,对今日 预防疫病的流行仍有启发。《伤寒论》记载了张仲景为代表的古代医家治疗“伤寒” 这一种急性传染病的临床经验。其中的麻黄汤、小柴胡汤、大承气汤、白虎汤、四逆 汤等经方,一直是后世医家治疗那些时令性传染病的主要方剂。宋金元时期以及明末 清初,中国的瘟疫也十分猖獗,医家们应用《伤寒论》里面的经方,结合临床多有创 新,并由此创立温病学,取得许多不可磨灭的贡献。
新型冠状病毒感染的肺炎属于中医“疫病”范畴,病因为感受疫戾之气,病位在肺,基本病机特点为“风、热、湿、毒、瘀”。
疫病初期,往往表现为邪在肺卫。正如《内经》所说“风淫于内,治以辛凉,佐 以干苦”,故治疗上应当宣肺透邪,清热解毒。
(三)发明内容
本发明目的是提供一种用于治疗疑似新冠肺炎的中药组合物及其制备与应用,针对疑似新冠肺炎的病机特点,在中医药理论指导下,通过各药材的合理配比,协同作 用,从中药材原料中筛选得到具有明确改善该疾患的中药组合物,制备得到能达到救 治疑似新型冠状病毒肺炎患者,改善症状,且无毒副作用,适合于人群服用的中药口 服制剂,对治疗疑似新冠肺炎具有明确效果。
本发明采用的技术方案是:
本发明提供一种用于治疗疑似新冠肺炎的中药组合物,所述中药组合物由如下质量配比的原料制成:金银花10~20份、连翘10~30份、荆芥10~20份、黄芩10~ 20份、大青叶10~20份、羌活10~20份、薄荷5~10份、牛蒡子10~30份、蝉衣 5~10份、僵蚕10~20份、鲜芦根10~30份、紫草10~30份、生甘草5~20份。
进一步,优选所述中药组合物由如下质量配比的原料制成:金银花15份、连翘 15份、荆芥10份、黄芩15份、大青叶12份、羌活10份、薄荷6份、牛蒡子15份、 蝉衣6份、僵蚕10份、鲜芦根30份、紫草15份、生甘草6份。
进一步,所述中药组合物还包括药学可接受的载体,制成本领域公知的汤剂、颗粒剂或口服液,本发明主要制成汤剂。
本发明提供一种所述中药组合物的制备方法,所述方法为:
按配方量,称取金银花、连翘、荆芥、黄芩、大青叶、羌活、薄荷、牛蒡子、蝉 衣、僵蚕、鲜芦根、紫草、生甘草,加入各药材总重量5倍量水浸泡1小时,加热煎 煮20分钟,沸后过滤;药渣再加3倍量水加热至沸,沸后过滤,合并滤液,浓缩至 密度1.02~1.2,获得汤剂。
本发明还提供一种所述中药组合物在制备治疗疑似新冠肺炎药物中的应用。
本发明所述疗疑似新冠肺炎需符合以下条件:有流行病学史中的任何一条,且符合临床表现中任意2条。无流行病史的,符合临床表现中的3条。其中,临床表现 包括以下3条:发热和或呼吸道症状;具有新冠肺炎影像学特征;发病早期白细胞总 数正常或降低,或淋巴细胞计数减少。
本发明所述的治疗疑似新冠肺炎中药组合物,选择金银花、连翘、荆芥、黄芩、 大青叶、羌活、薄荷、牛蒡子、蝉衣、僵蚕、鲜芦根、紫草、生甘草制备活性组分。
方中金银花、连翘辛凉透邪,清热解毒,用量最重,为君药。薄荷、荆芥辛散表 邪,透热外出,为臣药。其中荆芥虽为辛温解表之品,但温而不燥,又与金银花、连 翘同用,温性被制约,而增强其疏散清热之力。牛蒡子宣肺止咳,清利咽喉,黄芩、 大青叶甘凉清热,羌活解表祛风,蝉衣、僵蚕祛风清热,紫草清热凉血,芦根通而清 上,清肺胃之气分热盛,且能生津,均为佐药。甘草调和诸药为使药。诸药合用,共 奏疏风解表、清热解毒之功。
与现有技术相比,本发明有益效果要体现在:本发明中药组合物可明显改善新冠肺炎疑似患者的呼吸道症状,缩短隔离天数,减少并发症。且本发明中药组合物是在 中医理论指导下,以清热化痰为治疗原则选药组方,中药材治疗无明显毒副作用可长 服用,适用范围广。
(四)具体实施方式
下面结合具体实施例对本发明进行进一步描述,但本发明的保护范围并不仅限于此:
本发明实施例所用原料均按《中国药典》2015版采集制备。
实施例1
1、配方:所述中药组合物由如下质量配比的原料制成:金银花15份、连翘15份、 荆芥10份、黄芩15份、大青叶12份、羌活10份、薄荷6份、牛蒡子15份、蝉衣6份、僵 蚕10份、鲜芦根30份、紫草15份、生甘草6份。
2、制备:
按配方量,将金银花15g、连翘15g、荆芥10g、黄芩15g、大青叶12g、羌活10g、 薄荷6g、牛蒡子15g、蝉衣6g、僵蚕10g、鲜芦根30g、紫草15g、生甘草6g。按上 述重量配比的药材总重量,加5倍量水浸泡1小时,加热煎煮20分钟,沸后过滤; 药渣再加3倍量水加热至沸,沸后过滤,合并滤液。将上述合并的滤液浓缩至密度 1.02~1.2,制备得汤剂。
实施例2本发明中药组合物治疗疑似新冠肺炎临床观察
1、44例患者来自于浙江中医药大学附属第一医院、浙江中医药大学附属第二医院、浙江中医药大学附属第三医院、温岭第一人民医院、嘉兴市第一人民医院、富阳 区第一人民医院、安吉县中医医院,分别有17例、4例、1例、4例、8例、5例、5 例。研究采用队列研究法,以观察病例评价疗效总结为主,观察患者情况。按患者是 否口服中药,分为对照组和观察组,按临床治疗情况自然分组,不限定每组例数。
纳入标准:①新型冠状病毒肺炎疑似患者;②年龄在18-85岁之间;③知情同意 并签署知情同意书。
排除标准:①合并有心、肺、肝、肾、脑、造血系统等较严重的原发性疾病者; ②妊娠或哺乳期妇女;③精神病患者;④正在参加其它临床试验者或服用其他中草药 者。
终止标准:①患者要求退出;②患者确诊为新型冠状病毒肺炎;③治疗过程出现严重毒副反应者。
方法:根据患者意愿,决定是否应用中药治疗,按中药应用情况分为对照组和观察组。
对照组:常规西医治疗(参照国家卫健委和国家中管局联合发布的《新型冠状病毒感染的肺炎诊疗方案》试行第五版)。
观察组:确诊普通型新型冠状病毒肺炎患者在依据第五版《新型冠状病毒感染的肺炎诊疗方案》进行西医治疗的基础上,加用本发明实施例1方法制备的汤剂,一天 两次,每次50ml,疗程为7天。
2、结果:
(1)研究病例入组情况
表1病例入组情况
注:*1=浙江中医药大学附属第一医院,2=浙江中医药大学附属第二医院,3=浙江中医药大学附属第三医院,4=温岭第一人民医院,5=嘉兴市第一人民医院,6=富阳 区第一人民医院,7=安吉县中医医院,下同。
(2)主要临床症状基线情况
表2主要临床症状基线情况
注:N代表人数
(3)主要临床症状改善情况
表3主要临床症状改善情况
(4)转归情况
表4转归情况
(5)解除隔离天数
表5解除隔离天数
3.安全性评价(肝肾功能监测)
表6住院期间并发症情况
本本发明中药组合物可明显改善新冠肺炎疑似患者的呼吸道症状,缩短隔离天数,减少并发症,且无明显毒副作用可长服用,适用范围广。
Claims (5)
1.一种用于治疗疑似新冠肺炎的中药组合物,其特征在于所述中药组合物由如下质量配比的原料制成:金银花10~20份、连翘10~30份、荆芥10~20份、黄芩10~20份、大青叶10~20份、羌活10~20份、薄荷5~10份、牛蒡子10~30份、蝉衣5~10份、僵蚕10~20份、鲜芦根10~30份、紫草10~30份、生甘草5~20份。
2.如权利要求1所述的中药组合物,其特征在于所述中药组合物由如下质量配比的原料制成:金银花15份、连翘15份、荆芥10份、黄芩15份、大青叶12份、羌活10份、薄荷6份、牛蒡子15份、蝉衣6份、僵蚕10份、鲜芦根30份、紫草15份、生甘草6份。
3.如权利要求1所述的中药组合物,其特征在于所述中药组合物还包括药学可接受的载体,制成汤剂、颗粒剂或口服液。
4.一种权利要求1所述中药组合物的制备方法,其特征在于所述方法为:按配方量,称取金银花、连翘、荆芥、黄芩、大青叶、羌活、薄荷、牛蒡子、蝉衣、僵蚕、鲜芦根、紫草、生甘草,加入各药材总重量5倍量水浸泡1小时,加热煎煮20分钟,沸后过滤;药渣再加3倍量水加热至沸,沸后过滤,合并滤液,浓缩至密度1.02~1.2,获得汤剂。
5.一种权利要求1所述中药组合物在制备治疗疑似新冠肺炎药物中的应用。
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