CN116531471B - 一种用于治疗病毒感染湿热袭肺证的中药合剂 - Google Patents
一种用于治疗病毒感染湿热袭肺证的中药合剂 Download PDFInfo
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Abstract
一种用于治疗病毒感染湿热袭肺证的中药合剂,由以下重量的原料药制成:荆芥2‑10g、金银花2‑10g、北柴胡2‑8g、虎杖4‑12g、马鞭草5‑15g、黄芩2‑10g、射干4‑12g、前胡2‑10g、佩兰2‑10g、薏苡仁5‑15g、陈皮4‑12g和桔梗4‑12g。本发明组分配伍科学合理,原料丰富,制备方法简单,产品使用效果好,具有化湿解毒、疏风清热之功效,有效用于治疗病毒感染,经济和社会效益巨大。
Description
技术领域
本发明涉及中药技术领域,特别是一种用于治疗病毒感染湿热袭肺证的中药合剂。
背景技术
病毒感染是目前面临的最主要的公共卫生问题之一,且全球感染情况呈持续上升趋势。病毒具有传染性强、传播速度快、传播途径多样等特点,严重威胁人民群众的生命健康。根据现有病例资料,病毒肺炎以发热、干咳、乏力等为主要表现,少数患者伴有鼻塞、流涕、腹泻等上呼吸道和消化道症状。重症病例多在1周后出现呼吸困难,严重者快速进展为急性呼吸窘迫综合征、脓毒症休克、难以纠正的代谢性酸中毒和出凝血功能障碍及多器官功能衰竭等。
在漫长的历史中,中医药和病毒的斗争积累了丰富的理论认识和实践经验,为构建现代有中医特色的疫病防控体系提供了历史依据,为现代传染病的理论认知提供了技术依据。中医药方剂在防治现代疫病病毒方面应用广泛,贡献了巨大力量,能够显著减轻症状、延缓病情发展、促进恢复,在抗病毒的同时兼有调理机体、提高免疫力的作用,达到治愈和修复“双管齐下”的治疗效果。中医药在防治肺炎上具有一定的优势,不仅可以减轻患者症状,还可以根据不同的病情及体质情况,进行辨证论治。
病毒感染的中医病因为疫疠,疫病之前易先受风邪,凡寒、热、暑、湿、燥诸邪,又均可依附于风邪侵犯人体;其中携湿热易伤肺(卫)为其主要病机。此类患者,更需要借助中医药辨证论治,以期更好地提高患者生存质量,达到全面康复的目的。因此,开发出一种工艺简便、成本低、便于服用,用于治疗病毒感染的中药合剂,是目前所必需的,但至今未见公开报道。
发明内容
针对上述情况,为克服现有技术之缺陷,本发明之目的就是提供一种用于治疗病毒感染湿热袭肺证的中药合剂,可有效解决病毒感染的治疗用药问题。
为实现上述目的,本发明解决的技术方案是,一种用于治疗病毒感染湿热袭肺证的中药合剂,由以下重量的原料药制成:荆芥2-10g、金银花2-10g、北柴胡2-8g、虎杖4-12g、马鞭草5-15g、黄芩2-10g、射干4-12g、前胡2-10g、佩兰2-10g、薏苡仁5-15g、陈皮4-12g和桔梗4-12g,其中,将上述原料药加入6倍重量体积的水,重量体积是指固体以g计,液体以mL计,浸泡30min,大火煎沸,转文火煎煮1h,过滤,得第一次药液;药渣再加原料药物重量体积5倍的水大火煎沸,转文火煎煮1h,过滤,得第二次药液;合并两次药液,用80目滤网过滤,将过滤后的药液置于真空减压浓缩器中,浓缩至70℃相对密度为1.05-1.10的浓缩液,将浓缩液在8000r/min条件下离心10min,取上清液,煮沸30min,放冷至室温,得离心药液,加入苯甲酸钠2-5mg,再在12000r/min条件下高速离心10min,取上清液,加入阿司帕坦2-5mg,静置12h,滤过,加纯化水至100mL,搅匀,灌装于玻璃瓶,灭菌,即得成品。
本发明组分配伍科学合理,原料丰富,制备方法简单,产品使用效果好,具有化湿解毒、疏风清热之功效,有效用于治疗病毒感染,经济和社会效益巨大。
附图说明
图1是本发明的制备工艺流程图。
具体实施方式
以下结合附图和具体情况对本发明的具体实施方式作详细说明。
本发明在具体实施中可由以下实施例给出。
实施例1
一种用于治疗病毒感染湿热袭肺证的中药合剂,由以下重量的原料药制成:荆芥3-9g、金银花3-9g、北柴胡3-6g、虎杖5-10g、马鞭草6-12g、黄芩3-9g、射干4-12g、前胡3-9g、佩兰3-9g、薏苡仁6-12g、陈皮5-10g和桔梗5-10g,其中,将上述原料药加入6倍重量体积的水,浸泡30min,大火煎沸,转文火煎煮1h,过滤,得第一次药液;药渣再加原料药物重量体积5倍的水大火煎沸,转文火煎煮1h,过滤,得第二次药液;合并两次药液,用80目滤网过滤,将过滤后的药液置于真空减压浓缩器中,浓缩至70℃相对密度为1.05-1.10的浓缩液,将浓缩液在8000r/min下离心10min,取上清液,煮沸30min,放冷至室温,得离心药液,加入苯甲酸钠2.5-4.5mg,再在12000r/min下高速离心10min,取上清液,加入阿司帕坦2.5-4.5mg,静置12h,滤过,加纯化水至100mL,搅匀,灌装于玻璃瓶,灭菌,即得成品。
实施例2
一种用于治疗病毒感染湿热袭肺证的中药合剂,由以下重量的原料药制成:荆芥5g、金银花7g、北柴胡3g、虎杖9g、马鞭草12g、黄芩7g、射干10g、前胡8g、佩兰8g、薏苡仁11g、陈皮10g和桔梗8g。
实施例3
一种用于治疗病毒感染湿热袭肺证的中药合剂,由以下重量的原料药制成:荆芥7g、金银花8g、北柴胡6g、虎杖12g、马鞭草15g、黄芩10g、射干12g、前胡10g、佩兰10g、薏苡仁15g、陈皮12g和桔梗10g。
实施例4
一种用于治疗病毒感染湿热袭肺证的中药合剂,由以下重量的原料药制成:荆芥9g、金银花7g、北柴胡5g、虎杖7g、马鞭草10g、黄芩8g、射干11g、前胡9g、佩兰7g、薏苡仁12g、陈皮11g和桔梗9g。
实施例5
一种用于治疗病毒感染湿热袭肺证的中药合剂,由以下重量的原料药制成:荆芥7g、金银花9g、北柴胡6g、虎杖6g、马鞭草11g、黄芩7g、射干7g、前胡8g、佩兰5g、薏苡仁14g、陈皮7g和桔梗6g。
实施例6
一种用于治疗病毒感染湿热袭肺证的中药合剂,由以下重量的原料药制成:荆芥3g、金银花5g、北柴胡5g、虎杖8g、马鞭草9g、黄芩9g、射干11g、前胡10g、佩兰9g、薏苡仁11g、陈皮6g和桔梗7g。
本发明根据实际需要,可按上述组方配比制备任意所需成品药液的量,每日口服50-100mL、分为2-3次给药。
本发明所用中药,其中:
荆芥:辛,微温。归肺、肝经。功能与主治:解表散风,透疹,消疮。用于感冒,头痛,麻疹,风疹,疮疡初起。主要成分:挥发油成分包括胡薄荷酮、薄荷酮、亚麻酸等;萜类化合物包括8,15-异海松二烯-7β,18-二醇、α-生育醌等;黄酮类化合物包括芹菜素、山柰酚等。
金银花:甘,寒。归肺、心、胃经。功能与主治:清热解毒,疏散风热。用于痈肿疔疮,喉痹,丹毒,热毒血痢,风热感冒,温病发热。主要成分:黄酮类化合物包括木犀草素、忍冬苷等;有机酸类化合物包括绿原酸等;挥发油类化合物包括芳樟醇、棕榈酸等;环烯醚萜类化合物包括马钱苷等。
北柴胡:辛、苦,微寒。归肝、胆、肺经。功能与主治:疏散退热,疏肝解郁,升举阳气。用于感冒发热,寒热往来,胸胁胀痛,月经不调,子宫脱垂,脱肛。主要成分:皂苷类化合物包括柴胡皂苷a、柴胡皂苷c等;黄酮类化合物包括山柰酚-3-O-α-L-阿拉伯糖苷、山柰酚-3,7-二-O-α-L-鼠李糖苷等;挥发油累化合物包括L-坏血酸-2,6-二棕榈酸酯、2,4-癸二烯醛等。
虎杖:微苦,微寒。归肝、胆、肺经。功能与主治:利湿退黄,清热解毒,散瘀止痛,止咳化痰。用于湿热黄疸,淋浊,带下,风湿痹痛,痈肿疮毒,水火烫伤,经闭,癥瘕,跌打损伤,肺热咳嗽。主要成分:蒽醌类化合物包括大黄素甲醚-8-O-β-D-葡萄糖苷、大黄素-8-O-β-D-葡萄糖苷等;黄酮类化合物包括芹菜素、槲皮素等;苯丙素类化合物包括咖啡酸、阿魏酸等。
马鞭草:苦,凉。归肝、脾经。功能与主治:活血散瘀,解毒,利水,退黄,截疟。用于癥瘕积聚,痛经经闭,喉痹,痈肿,水肿,黄疸,疟疾。主要成分:黄酮类化合物包括甘草素、栗苷等;环烯醚萜类化合物包括马鞭草苷、9-羟基木犀苷等;萜类化合物包括熊果酸、齐墩果酸等。
黄芩:苦,寒。归肺、胆、脾、大肠、小肠经。功能与主治:清热燥湿,泻火解毒,止血,安胎。用于湿温、暑湿,胸闷呕恶,湿热痞满,泻痢,黄疸,肺热咳嗽,高热烦渴,血热吐衄,痈肿疮毒,胎动不安。主要成分:多糖类成分包括黄芩粗多糖等;黄酮类化合物包括黄芩素、查尔酮等;挥发油成分包括异戊二烯、苯二酸等。
射干:苦,寒。归肺经。功能与主治:清热解毒,消痰,利咽。用于热毒痰火郁结,咽喉肿痛,痰涎壅盛,咳嗽气喘。主要成分:黄酮类化合物包括鸢尾苷、野鸢尾苷等;甾类化合物包括3-豆甾烷醇、β-谷甾醇和胡萝卜苷等;挥发油成分包括桉叶醇、十四酸甲酯等。
前胡:苦、辛,微寒。归肺经。功能与主治:降气化痰,散风清热。用于痰热咳喘,咯痰黄稠,风热咳嗽痰多。主要成分:香豆素类化合物包括白花前胡甲素、白花前胡乙素、欧前胡素等;挥发油类包括β-榄香烯、香木兰烯等。
佩兰:辛,平。归脾、胃、肺经。功能与主治:芳香化湿,醒脾开胃,发表解暑。用于湿浊中阻,脘痞呕恶,口中甜腻,口臭,多涎,暑湿表证,湿温初起,发热倦怠,胸闷不舒。主要成分:挥发油类化合物包括对-聚伞花烃、橙花醇乙酯等。
薏苡仁:甘、淡,凉。归脾、胃、肺经。功能与主治:利水渗湿,健脾止泻,除痹,排脓,解毒散结。用于水肿,脚气,小便不利,脾虚泄泻,湿痹拘挛,肺痈,肠痈,赘疣,癌肿。主要成分:多糖类化合物包括淀粉、薏苡仁多糖A、B、C等;蛋白质和氨基酸;多酚类化合物包括对羟基苯甲酸、香草酸等。
陈皮:苦、辛,温。归肺、脾经。功能与主治:理气健脾,燥湿化痰。用于脘腹胀满,食少吐泻,咳嗽痰多。主要成分:黄酮类化合物包括橙皮苷、新橙皮苷等;挥发油类包括2-甲氨基-苯甲酸甲酯、D-柠檬烯等;生物碱类化合物包括辛弗林、N-甲基酪胺等。
桔梗:苦、辛,平。归肺经。功能与主治:宣肺,利咽,祛痰,排脓。用于咳嗽痰多,胸闷不畅,咽痛音哑,肺痈吐脓。主要成分:萜类化合物包括桔梗皂苷等;黄酮类化合物包括芹菜素、木樨草素等。
疫戾之气自口鼻入,首先犯肺,湿热阻于肺络,则肺失宣降,气机闭塞则邪热愈炽。里证虽盛于表证,本发明组方中,投以荆芥、金银花疏风透热,给肺热以外出之机,为君药;方用北柴胡,既取其清透之力,又取其退热之功,虎杖、马鞭草可清热解毒兼利水渗湿,同时具有清肺止咳的功效,直切病机,射干清热解毒,消痰利咽,《本经》谓之能“主咳逆上气,喉痹咽痛,不得消息,散结气”,黄芩上行可泻肺火,下行可清膀胱热,给湿热以出路,为治痰热要药,火性炎上,前胡降气化痰,可使气降则火降,而痰亦降,配伍桔梗开宣肺气,一升一降,以复肺宣发肃降之职,使化源不绝,同时肺热炽盛,熏灼咽喉,用桔梗、射干以清热利咽,北柴胡、虎杖、马鞭草、黄芩、射干、前胡、桔梗可达清热解毒、消痰利咽之功效,为臣药;疫邪多为湿邪,或为寒湿,或为湿热。佩兰功能辟秽,化湿,佐之以解疫病之寒热头痛,湿邪内蕴,脘痞不饥,口甘苔腻。薏苡仁健脾渗湿,兼扶正之用,具有化湿健脾作用的佩兰、薏苡仁两药为佐药;邪入气分阶段,病位常涉及脾胃,以陈皮为使调中快膈,消痰和胃。兼具疏风清热、化湿解毒功效。
本发明中药组合物按君臣佐使、配伍严谨、相辅相成,并经科学制备,质量稳定,疗效好,并经经临床实验取得了非常好的有益技术效果,有关实验资料如下(以实施例3为例):
一、病例选择:
1.1病例选择方法:试验病例为2022年10月-2022年12月在方舱医院收治的病毒感染湿热袭肺证患者。
1.2临床资料:随机选取方舱医院2022年10-12月收治轻型病毒感染湿热袭肺证患者250例,将患者随机分为试验组与对照组,每组各125例。研究过程中共脱落12例,其中试验组5例(数据不全2例,自行停止服药3例),对照组7例(数据不全2例,自行停止服药4例),最终共纳入分析238例,其中,试验组120例,男77例,女43例,年龄(34.38±10.48)岁,病程时间(1.38±0.97)d;对照组118例,男70例,女48例,年龄(35.58±11.73)岁,病程(1.43±0.94)d。
1.3选择指标:
(1)纳入标准:患者诊断为普通型病毒感染湿热袭肺证患者;患者咽拭子核酸检验阳性、抗体IgM检测阳性;纳入患者均无用药禁忌证;患者对治疗的依从性较良好;患者及其家属均知情同意且均签署相关知情同意书;患者均无青霉素、头孢类或磺胺药物过敏反应;
(2)排除标准:诊断为重型或危重型病毒感染患者;合并高血压、糖尿病以及冠心病等基础疾病患者。重症标准:呼吸窘迫,患者呼吸频率>30次/min;患者在静息状态或无吸氧状态时指脉氧≤93%;患者动脉血压分压(PaO2)/吸氧浓度(FiO2)<300mmHg(1mmHg=0.133kPa)。
二、治疗方案:
试验组全部服用实施例3制备的中药合剂,每日口服100mL,分为2次给药,以14天为观察期,主要观察发热、咳嗽、咽痛等症状改善情况。对照组全部服用中药安慰剂作为对照,口服每次100mL,每日2次;中药安慰剂采用辅料、色素相结合的方法制备而成;其中辅料采用上述极低剂量的合剂(5%实验药物)等,色素采用焦糖色等;安慰剂的包装、服用方法、口感与试验组完全一致,以14天为观察期,主要观察发热、咳嗽、咽痛等症状改善情况。所有患者服用该中药合剂或中药安慰剂均符合自愿原则。
三、观察指标:
比较两组患者核酸转阴时间、核酸转阴率、临床症状消退时间,评价中药合剂的疗效及安全性。
表1两组患者核酸转阴时间核酸转阴率(%)对比
注:*Fisher’s精确检验法。
表2两组患者临床症状的消退时间比较
结果显示,试验组在治疗14天后,核酸全部转阴,治疗第7天,试验组核酸转阴率明显高于对照组,两组核酸转阴率显示出显著差异(P<0.05);经统计学处理,采用本发明中药合剂对120例患者治疗,以10天转阴率计算,91人转阴,转阴率为75.8%,以14天转阴率计算,转阴率为100%,患者全部转阴,有关症状得到了有效改善。试验组患者在治疗第10天,仍有一半患者未转阴,治疗14天后,仍有8个患者未转阴,发热、咳嗽、气短症状的消退时间明显短于对照组,差异有统计学意义(P<0.05)。
四、典型病例
本实施例为部分感染患者信息与观察情况记录:(病例信息如下:)
病例1,男,37岁,检查确诊感染,症状表现为38℃以下低烧,有轻微鼻塞,鼻涕,轻微咳嗽,精神尚好。使用本发明实施例3的配方,制成合剂,口服100mL,分早晚两次服用。服用2天后,鼻塞鼻涕咳嗽症状消失,服药第4天不再反复低烧,第7天无复发低烧。停药三天后,无反复,双机构平行核酸检测病毒核酸检测转阴,病毒抗体IgM转阴。
因患者连续三天无发热,无明显呼吸道症状,双机构平行核酸检测阴性,经省市专家组审核同意出院。
病例2:女,45岁,检查确诊感染,病症表现为反复低烧,精神萎靡,无其他症状。使用本发明实施例3的配方,制成合剂,口服100mL,分早晚两次服用;服用2天后,低烧频率较第一天降低,第4天不再低烧,第7天服药停药。以后三天,低烧未复发,双机构平行核酸检测病毒核酸检测转阴,病毒抗体IgM转阴。
因患者连续三天无发热,无明显呼吸道症状,双机构平行核酸检测阴性,经省市专家组审核同意出院。
病例3,男,56岁,肺炎核酸检测阳性,病症表现为轻微咳嗽,流涕,伴有轻微头晕。使用本发明实施例3的配方,制成合剂,口服100mL,分早晚两次服用;服用4天后,头晕有改善,流涕减轻;服药第7天后,不再咳嗽;第10天后,各种症状消失。停药三天后,双机构平行核酸检测病毒核酸检测转阴,病毒抗体IgM转阴。
因患者连续三天无发热,无明显呼吸道症状,双机构平行核酸检测阴性,经省市专家组审核同意出院。
本发明在对实施例3进行上述试验的同时,还对其他实施例进行了试验,均取得了相同和相近似的结果,这里不再一一列举,表明本发明效果好,疗效稳定可靠。
五、结论
综上所述,本发明组分原料丰富,配伍科学合理,配伍科学,成本低,效果好,服用方便,治疗病毒感染湿热袭肺证疗效明显,经14天治疗后,患者全部转阴;君臣佐使配伍,组分间彼此相互支持,相互配合,具有化湿解毒、疏风清热之功效,有效用于病毒感染湿热袭肺证,是治疗病毒感染湿热袭肺证药物上的一大创新,经济和社会效益巨大。
要说明的是,本申请的技术特征和关键是中药组合物配伍,上述给出的中药合剂仅是一个剂型的实施例,凡是采用等同等效替换手段所作出的在本质上与本申请相同的技术方案或采用本申请中药组合物以常规制剂方法所制得适用服用的各种剂型,如粉剂(散剂)、颗粒剂、丸剂、片剂、口服液、胶囊剂、浸膏粉等等,均属于本申请的保护范围。
Claims (7)
1. 一种用于治疗病毒感染湿热袭肺证的中药合剂,其特征在于,由以下重量的原料药制成:荆芥2-10g、金银花2-10g、北柴胡2-8g、虎杖4-12g、马鞭草5-15g、黄芩2-10g、射干4-12g、前胡2-10g、佩兰2-10g、薏苡仁5-15g、陈皮4-12g和桔梗4-12g,其中,将上述原料药加入6倍重量体积的水,重量体积是指固体以g计,液体以mL计,浸泡30min,大火煎沸,转文火煎煮1h,过滤,得第一次药液;药渣再加原料药物重量体积5倍的水大火煎沸,转文火煎煮1h,过滤,得第二次药液;合并两次药液,用80目滤网过滤,将过滤后的药液置于真空减压浓缩器中,浓缩至70℃相对密度为1.05-1.10的浓缩液,将浓缩液在8000r/min条件下离心10min,取上清液,煮沸30min,放冷至室温,得离心药液,加入苯甲酸钠2-5mg,再在12000r/min条件下高速离心10min,取上清液,加入阿司帕坦2-5mg,静置12 h,滤过,加纯化水至100mL,搅匀,灌装于玻璃瓶,灭菌,即得成品。
2. 根据权利要求1所述的用于治疗病毒感染湿热袭肺证的中药合剂,其特征在于,由以下重量的原料药制成:荆芥3-9g、金银花3-9g、北柴胡3-6g、虎杖5-10g、马鞭草6-12g、黄芩3-9g、射干4-12g、前胡3-9g、佩兰3-9g、薏苡仁6-12g、陈皮5-10g和桔梗5-10g,其中,将上述原料药加入6倍重量体积的水,浸泡30min,大火煎沸,转文火煎煮1 h,过滤,得第一次药液;药渣再加原料药物重量体积5倍的水大火煎沸,转文火煎煮1 h,过滤,得第二次药液;合并两次药液,用80目滤网过滤,将过滤后的药液置于真空减压浓缩器中,浓缩至70℃相对密度为1.05-1.10的浓缩液,将浓缩液在8000r/min下离心10min,取上清液,煮沸30min,放冷至室温,得离心药液,加入苯甲酸钠2.5-4.5mg,再在12000r/min下高速离心10min,取上清液,加入阿司帕坦2.5-4.5mg,静置12h,滤过,加纯化水至100mL,搅匀,灌装于玻璃瓶,灭菌,即得成品。
3.根据权利要求1所述的用于治疗病毒感染湿热袭肺证的中药合剂,其特征在于,由以下重量的原料药制成:荆芥5g、金银花7g、北柴胡3g、虎杖9g、马鞭草12g、黄芩7g、射干10g、前胡8g、佩兰8g、薏苡仁11g、陈皮10g和桔梗8g。
4.根据权利要求1所述的用于治疗病毒感染湿热袭肺证的中药合剂,其特征在于,由以下重量的原料药制成:荆芥7g、金银花8g、北柴胡6g、虎杖12g、马鞭草15g、黄芩10g、射干12g、前胡10g、佩兰10g、薏苡仁15g、陈皮12g和桔梗10g。
5.根据权利要求1所述的用于治疗病毒感染湿热袭肺证的中药合剂,其特征在于,由以下重量的原料药制成:荆芥9g、金银花7g、北柴胡5g、虎杖7g、马鞭草10g、黄芩8g、射干11g、前胡9g、佩兰7g、薏苡仁12g、陈皮11g和桔梗9g。
6.根据权利要求1所述的用于治疗病毒感染湿热袭肺证的中药合剂,其特征在于,由以下重量的原料药制成:荆芥7g、金银花9g、北柴胡6g、虎杖6g、马鞭草11g、黄芩7g、射干7g、前胡8g、佩兰5g、薏苡仁14g、陈皮7g和桔梗6g。
7.根据权利要求1所述的用于治疗病毒感染湿热袭肺证的中药合剂,其特征在于,由以下重量的原料药制成:荆芥3g、金银花5g、北柴胡5g、虎杖8g、马鞭草9g、黄芩9g、射干11g、前胡10g、佩兰9g、薏苡仁11g、陈皮6g和桔梗7g。
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