CN113082170A - 一种用于抑制2019-nCoV的中药制剂及其制备方法 - Google Patents
一种用于抑制2019-nCoV的中药制剂及其制备方法 Download PDFInfo
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Abstract
本发明提供了一种用于抑制2019‑nCoV的中药制剂及其制备方法。该中药制剂的原料组分配比如下：冬桑叶10‑20g、薄荷叶5‑15g、紫苏叶6‑10g、藿香叶5‑15g、淡竹叶2‑10g、金银花15‑25g、菊花15‑25g、蕲艾20‑30g，其制备工艺为：粉碎、煎煮和浓缩。本发明的有益效果：1.选用多种中药材原料复配，起到增效抗炎抗病毒的作用；2.所选药材大部分为药食同源类中药材，组分安全性高，既能够有效避免和减轻副作用及不良反应，又能较好地抑制2019‑nCoV，可用于辅助治疗新冠肺炎；3.本发明所制备的中药成本低廉、服用方便、起效快，制备工艺简单，质控容易，方便批量生产，且其抗炎抗病毒作用并不局限于新型冠状病毒肺炎。
Description
技术领域
本发明属于中药技术领域，具体涉及一种用于抑制2019-nCoV的中药制剂及其制备方法。
背景技术
在新冠肺炎的治疗过程中，中西医结合疗法具有一定的效果。目前已有60个候选疫苗被批准进入临床试验，治疗药物主要有瑞德西韦、氯喹等。预防新冠肺炎的中药以甘草、苍术及藿香使用频次最高，临床中筛选出“三方三药”等有效方剂。截止到目前，中药总有效率达到了91.5％。部分西药的使用可能出现不良反应，如引发胃溃疡、肝肾功能损害等副作用。而部分中药在使用过程中也可能存在不良反应，如：连花清瘟胶囊和藿香正气制剂易出现胃肠不适；藿香正气水因含有乙醇，禁止与具有甲硫四氮唑侧链的头孢菌素等联用，以免引起双硫仑样反应。因而，研发一款安全性高的、温和的中医药产品具有重要的现实意义。
发明内容
为了解决上述技术问题，本发明提供一种用于抑制2019-nCoV的中药制剂及其制备方法。该配方的中药原料均为天然药用植物，且大部分为药食同源类中药材，组方安全性高，具有抗炎、抗病毒、解热等功效，能够减轻副作用及不良反应。
本发明提供的技术方案如下：
一种用于抑制2019-nCoV的中药制剂，由中药原料煎煮制备，所述中药原料为冬桑叶 10-20g、薄荷叶5-15g、紫苏叶6-10g、藿香叶5-15g、淡竹叶2-10g、金银花15-25g、菊花15-25g 和蕲艾20-30g。
优选的，所述中药原料为冬桑叶12-16g、薄荷叶6-12g、紫苏叶6-10g、藿香叶8-12g、淡竹叶4-8g、金银花18-22g、菊花16-20g和蕲艾24-28g。
本发明的另一目的在于提供上述中药制剂的制备方法，包括以下步骤：
(1)粉碎：将冬桑叶、薄荷叶、紫苏叶、藿香叶、淡竹叶、金银花、菊花和蕲艾粉碎备用；
(2)煎煮：将粉碎后的药材粉末投料到水中，煎煮后收煎煮液；然后进行第二次加水，煎煮后收煎煮液；
(3)浓缩：收集两次煎煮液合并，过筛，用旋转减压蒸馏浓缩罐，分次加液减压浓缩，并趁热瓶装封口。
进一步，所述步骤(2)种煎煮次数为两次，第一次煎煮加水量为2-2.4L水，煎煮时间为1-2h；第二次煎煮加水量2-2.4L，煎煮0.5-1.5h。
进一步，所述步骤(3)中筛子目数为80-100目。
进一步，所述步骤(3)中浓缩体积至80-100ml，相对密度约ρ1.10-1.20。
本发明所用原料具有如下特性：
冬桑叶：别名霜桑叶，药食同源植物，性寒，味甘、苦，归肺、肝经，具有疏散风热、清肺润燥等功效。研究发现，其富有黄酮类、生物碱类、苯丙素类、挥发油、甾体、有机酸等化学成分，现代药理研究证明其具有抗氧化、抗炎、抗血小板聚集、免疫调节和心血管保护等生物学功能。
菊花：药食同源植物，性微寒，含挥发油、腺嘌呤、胆碱、水苏碱、菊甙、氨基酸、黄酮类及微量维生素B1等有效澄粉。现代医学表明，菊花具有抗炎、抗衰老、抗氧化、清热、解毒的功效，临床多用于外感风热、发热、恶寒、目赤肿痛等症状。
藿香叶：药食同源植物，富含铁、钙、碳水化合物、维生素A等营养物质，含有挥发性香油，具有独特香味。现代药理研究表明藿香叶具有理气和胃、止泻、发汗解表、祛暑等功效。临床上可用来治疗湿阻中焦，外感风寒，腹痛吐泻等疾病，使用时可以配紫苏等药物一同使用。
紫苏叶：药食同源植物，性温，味辛。归肺经、脾经。其主要化学成分有紫苏醛、紫苏酮，白苏酮、薄荷醇、高山黄芩苷、新西兰牡荆苷Ⅱ、鹭樱苷等。现代药理学研究发现：紫苏叶具有镇静解热、止咳祛痰平喘、止血和抗凝血、调节机体免疫功能的作用。
金银花：药食同源植物，味甘，入肺、心、胃经，自古被誉为清热解毒的良药。现代研究证明，金银花含有绿原酸、木犀草素苷等药理活性成分，对多种致病菌及上呼吸道感染致病病毒等有较强的抑制力，另外还可增强免疫力、消炎、解热等。其临床用途非常广泛，可与其它药物配伍用于治疗呼吸道感染、急性泌尿系统感染等病症。
蕲艾：中医记载其具有温经、去湿、散寒、消炎、平喘、止咳等功效。研究发现，其富含挥发油、黄酮、有机酸类以及生物碱等活性物质，现代药理研究证明其具有抗菌、抗病毒和提高机体免疫力等生物学功能。目前被广泛应用于医药、保健品、烟业、食品及化妆品等领域。
淡竹叶：药食同源植物，其性味甘淡，竹叶中含有大量的黄酮类化合物和生物活性多糖及其它有效成分，如酚酸类化合物、蒽醌类化合物、萜类内酯、特种氨基酸和活性肤、锰、锌、硒等微量元素。现代药理学研究发现：紫苏叶具有解热、利尿、抗菌等作用。
薄荷叶：药食同源植物，主要含薄荷油、薄荷醇以及薄荷酮、异薄荷酮、迷迭香酸等成分，具有抗病毒、抗炎、健胃保肝、增加呼吸道粘液分泌等功效。临床多用于风热感冒、温病初起、头痛目赤、咽喉肿痛等症状。
上述八种中药材配伍一起使用，具有较好的抗病毒作用：冬桑叶主入手太阴肺经，兼入足厥阴肝经，散风力强；菊花主入足厥阴肝经，兼入手太阴肺经，清热力彰。二味协同为用，并走上焦则疏风清热、润肺止咳；同入下焦则清热平肝，益阴明目叫。藿香叶辛散风寒，芳化湿浊，悦脾和中，既能解暑发表，又能化湿和中。紫苏发表散寒、行气宽中，外而开皮毛通腠理而入肺经，内而开胸隔化湿浊入脾胃。四药相辅相承，具有疏解表邪，理气化痰、和胃降逆之效。
金银花、蕲艾、淡竹叶、薄荷叶均包括有机酸类、黄酮类、挥发油类等有效成分。黄酮类化合物具有病毒生长和局部镇痛作用，有机酸类具有抗炎、抗病毒增强机体免疫力等功效。实验表明，金银花、艾叶、淡竹叶及薄荷叶配伍可增强其黄酮类化合物含量生物效能，进而增效其抗炎抗病毒的功能。
综上所述，本发明所选用的八种原材料按照一定的用量搭配，选取适宜的温度和煎煮时间，可使原材料中黄酮类、有机酸类、挥发油类等有效成分发生溶出率的改变、挥发、水解、氧化等变化，使其含量并不等于单味药化学成分的简单相加，从而增强了其抗炎、抗病毒、解热等功效，能较好地抑制2019-nCoV，可用于辅助治疗新冠肺炎。
本发明的有益效果：
(1)本发明选用的八种原材料均具有抗炎、抗病毒、解热等功效，结合了中医理念，利用多种中药复配，有效成分协同作用，起到增效抗炎抗病毒的作用；
(2)本发明选用的八种原材料均为天然材植物药材，且大部分为药食同源类中药材，组分安全性高，既能够有效避免和减轻副作用及不良反应，增强机体免疫力，又能较好地抑制 2019-nCoV，可用于辅助治疗新冠肺炎。
(3)本发明所制备的中药成本低廉、服用方便、起效快，制备工艺简单，质控容易，方便批量生产，且其抗炎抗病毒作用并不局限于新型冠状病毒肺炎。
具体实施方式
为了更好地理解本发明，下面结合实施例对本发明的实施方案进行详细描述，但下列实施例仅用于说明本发明，而不应视为限制本发明的范围。
实施例1
一种用于防治新冠肺炎的中药的制备方法，包括以下步骤：
粉碎：冬桑叶12g、薄荷叶6g、紫苏叶6g、藿香叶8g、淡竹叶4g、金银花18g、菊花16g、蕲艾24g。
(2)煎煮：将步骤(1)中所得药材粉末投入10L小试提取罐中，加水2L，煎煮1h后收煎煮液；然后进行第二次加水2L，煎煮0.5h后收煎煮液；
(3)浓缩：收集两次煎煮液合并，过80目筛，用旋转减压蒸馏浓缩罐，分次加液减压浓缩至100ml(相对密度约1.10)，并趁热瓶装封口。
实施例2
一种用于防治新冠肺炎的中药的制备方法，包括以下步骤：
粉碎：冬桑叶14g、薄荷叶9g、紫苏叶8g、藿香叶10g、淡竹叶6g、金银花20g、菊花18g、蕲艾26g。
(2)煎煮：将步骤(1)中所得药材粉末投入10L小试提取罐中，加水2.2L，煎煮1.5h后收煎煮液；然后进行第二次加水2.2L，煎煮1h后收煎煮液；
(3)浓缩：收集两次煎煮液合并，过90目筛，用旋转减压蒸馏浓缩罐，分次加液减压浓缩至90ml(相对密度约1.16)，并趁热瓶装封口。
实施例3
一种用于防治新冠肺炎的中药的制备方法，包括以下步骤：
粉碎：冬桑叶16g、薄荷叶12g、紫苏叶10g、藿香叶12g、淡竹叶8g、金银花22g、菊花20g、蕲艾28g。
(2)煎煮：将步骤(1)中所得药材粉末投入10L小试提取罐中，加水2.4L，煎煮2h 后收煎煮液；然后进行第二次加水2.4L，煎煮1.5h后收煎煮液；
(3)浓缩：收集两次煎煮液合并，过100目筛，用旋转减压蒸馏浓缩罐，分次加液减压浓缩至80ml(相对密度约1.20)，并趁热瓶装封口。
实施例4
实施例1、实施例2和实施例3抗2019-nCoV的体外实验
主要实验材料：
供试品：实施例1、实施例2和实施例3制备的中药制剂；
对照药：PBS处理细胞组为阴性对照药；
细胞：Vero-E6细胞
毒株：2019-nCoV病毒株；
试剂：CCK-8试剂、新生牛血清(2％FBS)(美国Hyclone公司)、四甲基偶氮唑蓝(methyl thiazolyl tetrazolium，MTT)和结晶紫(美国Sigma公司)、细胞级二甲基亚砜、RPMI-1640细胞维持液、青霉素G钠、链霉素、PBS磷酸盐缓冲溶液、EDTA－0.25％胰酶(美国GibcoBRL 公司)、0.1％中性红染料。
(2)实验方法：
供试品的稀释：用温水分别将实施例1、实施例2及实施例3按1:10、1:100、1:1000稀释。
细胞的复苏与培养：将液氮罐中的细胞冻存管取出，立即投入37℃～40℃温水中迅速搅动，至冻存液完全溶解(尽量在1min内完成)；将冻存管1000r/min离心5min，取出，在超净工作台内打开，弃冻存液；加入10％1640细胞培养液适量，加2％FBS培养，常规加入青霉素100V/mL和链霉素100ug/L。将下层沉淀细胞吹打混匀，转移到培养瓶内，补加10％1640细胞培养液至12mL，在37℃、5％CO2恒温培养箱培养。Vero-E6细胞:待细胞长成单层后，按1:3传代，继续培养，隔天进行传代。
细胞毒性实验：参照CCK-8细胞计数法，对细胞点板后培养约24h，换液，每孔加2％FBS 培养基180μL，依次加入20μL的阴性对照组和各剂量组受试物，每组重复6孔，培养24h后，每孔加入CCK-8试剂20μL，1h后测各孔吸光度根据吸光度计算各组对细胞的抑制率。抑制率计算公式，抑制率(％)＝[1-OD(处理组)/OD(Mock组)]×100。
抗病毒效果实验：参照荧光定量PCR法，对细胞点板后培养24h，换液，依次加入200μL 的稀释好的阴性对照组和各剂量组受试物，每组重复3孔，同时加入0.01moi的病毒，培养 24h后，每孔取细胞培养上清用Q-PCR的方法测定病毒RNA拷贝数。抑制率计算公式，抑制率(％)＝[1-RNA Copy(处理组)/RNA Copy(Mock组)]×100。
(3)实验结果：
细胞毒性实验结果如表1所示：
表1不同浓度的实施例1、2和3中药制剂细胞毒性实验结果
抗病毒效果如表2所示：
表2不同浓度的实施例1、2和3中药制剂抗病毒实验结果
实验结果表明，本研究所制备的所有中药加入Vero-E6细胞中，对其增殖抑制率不超过 20％，认为其对细胞无毒性；且本中药能有效抑制Vero-E6细胞中新型冠状病毒的复制，抑制率均超过96％，最高达99.99％。由此可以说明本发明的中药组方安全性高，且对新冠肺炎的防治具有积极作用。
以上所述，仅为本发明较佳的具体实施方式，但本发明保护的范围并不局限于此，任何熟悉本技术领域的技术人员在本发明揭露的技术范围内所做的任何修改，等同替换和改进等，均应包含在发明的保护范围之内。
Claims (6)
1.一种用于抑制2019-nCoV的中药制剂，其特征在于，由中药原料煎煮制备，所述中药原料为冬桑叶10-20g、薄荷叶5-15g、紫苏叶6-10g、藿香叶5-15g、淡竹叶2-10g、金银花15-25g、菊花15-25g和蕲艾20-30g。
2.根据权利要求1所述的中药制剂，其特征在于，所述中药原料为冬桑叶12-16g、薄荷叶6-12g、紫苏叶6-10g、藿香叶8-12g、淡竹叶4-8g、金银花18-22g、菊花16-20和蕲艾24-28g。
3.权利要求1或2所述的中药制剂的制备方法，其特征在于，包括以下步骤：
(1)粉碎：将冬桑叶、薄荷叶、紫苏叶、藿香叶、淡竹叶、金银花、菊花和蕲艾粉碎备用；
(2)煎煮：将粉碎后的药材粉末投料到水中，煎煮后收煎煮液；然后进行第二次加水，煎煮后收煎煮液；
(3)浓缩：收集两次煎煮液合并，过筛，用旋转减压蒸馏浓缩罐，分次加液减压浓缩，并趁热瓶装封口。
4.根据权利要求3所述的方法，其特征在于：所述步骤(2)种煎煮次数为两次，第一次煎煮加水量为2-2.4L水，煎煮时间为1-2h；第二次煎煮加水量2-2.4L，煎煮0.5-1.5h。
5.根据权利要求3所述的方法，其特则在于：所述步骤(3)中筛子目数为80-100目。
6.根据权利要求3所述的方法，其特则在于：所述步骤(3)中浓缩体积至80-100ml。
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