CN111467451B - 一种治疗新型冠状病毒肺炎的组合物、制剂及其应用 - Google Patents
一种治疗新型冠状病毒肺炎的组合物、制剂及其应用 Download PDFInfo
- Publication number
- CN111467451B CN111467451B CN202010393600.4A CN202010393600A CN111467451B CN 111467451 B CN111467451 B CN 111467451B CN 202010393600 A CN202010393600 A CN 202010393600A CN 111467451 B CN111467451 B CN 111467451B
- Authority
- CN
- China
- Prior art keywords
- parts
- preparation
- radix
- composition
- granules
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/233—Bupleurum
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/34—Campanulaceae (Bellflower family)
- A61K36/344—Codonopsis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/42—Cucurbitaceae (Cucumber family)
- A61K36/428—Trichosanthes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/484—Glycyrrhiza (licorice)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/539—Scutellaria (skullcap)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/57—Magnoliaceae (Magnolia family)
- A61K36/575—Magnolia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/65—Paeoniaceae (Peony family), e.g. Chinese peony
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/70—Polygonaceae (Buckwheat family), e.g. spineflower or dock
- A61K36/704—Polygonum, e.g. knotweed
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/75—Rutaceae (Rue family)
- A61K36/752—Citrus, e.g. lime, orange or lemon
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/888—Araceae (Arum family), e.g. caladium, calla lily or skunk cabbage
- A61K36/8888—Pinellia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/889—Arecaceae, Palmae or Palmaceae (Palm family), e.g. date or coconut palm or palmetto
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
- A61K36/8964—Anemarrhena
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/906—Zingiberaceae (Ginger family)
- A61K36/9064—Amomum, e.g. round cardamom
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/14—Antivirals for RNA viruses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
Landscapes
- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Botany (AREA)
- Mycology (AREA)
- Epidemiology (AREA)
- Microbiology (AREA)
- Medical Informatics (AREA)
- Biotechnology (AREA)
- Alternative & Traditional Medicine (AREA)
- Virology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Molecular Biology (AREA)
- Neurosurgery (AREA)
- Communicable Diseases (AREA)
- Oncology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pulmonology (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
本发明涉及一种治疗新型冠状病毒肺炎的组合物,由如下重量份中药组成:柴胡18‑25份、黄芩8‑15份、法半夏8‑15份、全瓜蒌8‑15份、党参15‑20份、槟榔8‑15份、草果15‑20份、厚朴15‑20份、知母8‑15份、赤芍8‑15份、甘草8‑15份、陈皮8‑15份、虎杖8‑15份。本发明最大限度地保留了传统医药积累的用药经验,又适应于现代社会服用方便、口感好等优点,并已在临床上得到广泛应用与验证,疗效确切,治疗效果良好。
Description
技术领域
本发明涉及中药制剂领域,具体涉及一种治疗新型冠状病毒肺炎的组合物、制剂及其应用。
背景技术
新型冠状病毒肺炎(COVID-19)是由新型冠状病毒引起的急性感染性肺炎,具有传染性强和流行性高的特点,人群普遍易感。该病毒症状一般为发热、乏力、干咳、逐渐出现呼吸困难,严重者表现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凝血功能障碍。
目前临床上尚无治疗COVID-19的特效药,西医治疗以支持治疗和对症治疗为主,支持疗法则以维持水、电解质平衡和氧疗为主,但临床疗效差,治愈率低,一般仅对重症患者考虑用西医治疗。
中医药历史悠久,在疫病的防治方面积累了丰富的经验,目前急需研发一种适合工业化大规模生产,大规模应用于临床患者治疗和预防COVID-19疾病的中成药。
发明内容
为解决上述技术问题,本发明提供的技术方案如下:
一种治疗新型冠状病毒肺炎的组合物,由如下重量份中药组成:柴胡18-25份、黄芩8-15份、法半夏8-15份、全瓜蒌8-15份、党参15-20份、槟榔8-15份、草果15-20份、厚朴15-20份、知母8-15份、赤芍8-15份、甘草8-15份、陈皮8-15份、虎杖8-15份。
优选地,由如下重量份中药组成:柴胡20份、黄芩10份、法半夏10份、全瓜蒌10份、党参15份、槟榔10份、草果15份、厚朴15份、知母10份、赤芍10份、生甘草10份、陈皮10份、虎杖10份。
本发明提供的配方在经典古方达原饮、小柴胡汤、小陷胸汤基础上,根据COVID-19特性加减化裁而成。方中柴胡味苦微寒,升阳达表,疏利阻滞的邪气,能退疫毒所致之身热;黄芩苦寒,养阴退热,与柴胡配伍能清透三焦热邪,半夏辛温,健脾燥湿,与柴胡配伍升清降浊,疏利三焦,全瓜蒌甘寒,清热涤痰,宽胸散结。槟榔能辛散湿邪、消除伏邪,既能疏利又可除瘴气,厚朴祛湿化浊、破戾气所结,草果辛烈化浊、除温邪所盛,三味药协力直达其巢穴使邪气溃散,因热伤津液,加知母滋阴,赤芍养血,人参、甘草益气扶正,抵御病邪。而方中虎杖、陈皮是针对本次新型冠状病毒感染的肺炎临床症状加减,用于抗病毒、化痰。
进一步地,所述组合物制成药学上可接受的颗粒剂、胶囊剂和片剂。
进一步地,所述颗粒剂的制备方法为,按重量比称取处方药材,加水提取2-4次,每次0.5-3小时,收集挥发油和提取液,挥发油用4-8倍β环糊精包合,提取液过滤,60-80℃浓缩至相对密度为1.05~1.20(60-80℃)的浸膏,干燥,加入挥发油包合物和辅料后制备成颗粒剂。
优选地,所述提取次数为两次,第一次加8倍量水,提取120分钟,并收集挥发油,第二次加6倍量水,提取45分钟,合并两次提取液,120目滤过,该条件提取加水少,浓缩快,能耗低。
优选地,所述干燥工艺为喷雾干燥或真空减压干燥。喷雾干燥设备参数为引风机频率40Hz~50Hz,雾化器频率40Hz~50Hz,进风温度150-170℃;真空减压干燥温度为70℃,该温度既不破坏处方有效成分,也不易使浓缩液产生气泡。
优选地,本发明所述颗粒剂由配方13味药材按单药逐个提取,浓缩,干燥,得各13味配方颗粒干膏粉,将13味配方颗粒干膏粉按制成量当量关系按处方比例调配得颗粒剂。
本发明所采用辅料包括但不限于麦芽糊精、糊精、糖粉、聚维酮、聚乙二醇、木糖醇、β-环糊精等常用药用辅料中的一种或数种组合。
更进一步,本发明提供了上述组合物在制备治疗肺炎疾病的药物中的应用,尤其是所述肺炎为由病毒感染所致的肺炎。所述病毒包括但不限于新型冠状病毒COVID-19、呼吸系统综合症冠状病毒及呼吸道合胞病毒等。大量临床试验证实,本发明所述制剂对新型冠状病毒2019-nCoV感染引发的肺炎具有良好的治疗效果。
本发明的有益效果:
1、本发明通过清热、解毒、养阴、除湿、扶正气综合治疗,最终实现疾病去除的目的。
2、本发明临床效果显著,疫情期间本发明处方已在武汉、黄石等湖北各地临床上广泛应用,从目前收集到的500多例临床患者数据统计,临床有效率达90%以上。
3、本申请相对于传统汤剂,通过制备成中药现代制剂,调配方便,临床服用方便,质量可控,适用于工业化大规模生产。
附图说明
图1是本申请实施例3提供样品中黄芩薄层鉴别图,其中1为阴性对照,2为样品1、3为样品2、4为样品3、5为样品3点用量加倍、6为黄芩苷对照品、9为黄芩对照药材。
图2是本申请实施例3提供样品中厚朴薄层鉴别图,其中1为阴性对照,2为样品1、3为样品2、4为样品3、6为厚朴酚、和厚朴酚混合对照品。
图3是本申请实施例3提供样品中赤芍薄层鉴别图,其中1为阴性对照,2为样品1、3为样品2、4为样品3、5为芍药对照药材、6为芍药苷对照品。
图4是本申请实施例3提供样品中黄芩苷含量测定色谱图,3号峰为黄芩苷。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白,下面结合附图和具体实施例对本发明做进一步说明。应当理解,此处所描述的具体实施例仅用以解释本发明,并不用于限定本发明。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
实施例1
分别称取处方药材柴胡37kg,黄芩18.5kg,法半夏18.5kg,党参27.8kg,瓜蒌18.5kg,槟榔18.5kg,草果仁27.8kg,厚朴27.8kg,知母18.5kg,赤芍18.5kg,甘草18.5kg,陈皮18.5kg,虎杖18.5kg,加水提取两次,第一次加8倍量水,提取120分钟,并收集挥发油,第二次加6倍量水,提取45分钟,合并两次提取液,120目滤过,60-80℃浓缩至相对密度为1.05~1.20(60-80℃)的浸膏,在引风机频率40Hz~50Hz,雾化器频率40Hz~50Hz,进风温度150-170℃条件下喷雾干燥的干膏粉,将挥发油用6倍(ml:g)β环糊精包合,将干膏粉、挥发油包合物和一定量辅料充分混合均匀后干法制粒,制成100kg颗粒,包装成每袋装18g,即得,每日服用3袋。
实施例2
分别将处方13味药材逐个按数字化提取工艺单独提取,浓缩,干燥,得各13味配方颗粒干膏粉,将13味配方颗粒干膏粉按制成量当量关系按处方比例调配,并加入一定量辅料,制成10kg,包装成每袋装18g,每日服用3袋。各物料详细添加比例关系详见下表1。
表1清肺达原复方颗粒调配当量关系表
实施例3
任取实施例1和2成品配方颗粒三批次,编号为样品1、样品2、样品3,对所得制剂进行薄层鉴别、含量测定,鉴别本发明所得的制剂产品成分含量符合要求,以确保有效物质得到充分提取和利用。
本实施例分别对样品种黄芩、厚朴、赤芍进行薄层鉴别和含量测定。
黄芩薄层鉴别方法为:称取本品粉末3g,研细,加甲醇30ml,超声处理30分钟,滤过,滤液浓缩至约5ml,作为供试品。另取黄芩对照药材1g,同法制成对照药材溶液;再取黄芩苷对照品,加甲醇制成每1ml含1mg的溶液,作为对照品溶液。按照薄层色谱法(2015版《中国药典》通则0502)进行试验。吸取上述三种溶液各5μl,分别点于同一硅胶G薄层板上,以乙酸乙酯-丁酮-甲酸-水(5∶3∶1∶1)为展开剂,预饱和30min,展开,取出,晾干,喷以1%三氯化铁乙醇溶液,在日光下检视。供试品色谱中,在与对照药材色谱相应的位置上,显相同颜色的斑点;在与对照品色谱相应的位置上,显相同的暗绿色斑点。
厚朴薄层鉴别方法为:取本品粉末10g,加乙醇50ml,超声处理30min,过滤蒸干,加水20ml使溶解,用乙醚振摇提取2次,每次20ml,合并乙醚液,蒸干,残渣加1ml甲醇溶解即得。另取厚朴酚对照品、和厚朴酚对照品,加甲醇制成每1ml各含1mg的混合溶液,作为对照品溶液。取供试品溶液30μl,混合对照品10μl于同一硅胶G薄层板上,以甲苯-甲醇(17:1)为展开剂,展开,取出,晾干,喷以1%香草醛硫酸溶液,在100℃加热至斑点显色清晰。在供试品色谱图中,在与对照品相应的位置,显现相同颜色的斑点,阴性对照在相应位置上无斑点。
赤芍薄层鉴别方法为:取本品粉末10g,研细;加乙醇40ml,超声处理20min,滤过,滤液蒸干,残渣加水20ml溶解,用水饱和的正丁醇振摇提取两次,每次20ml,合并正丁醇液,蒸干,残渣加乙醇溶液1ml使溶解,作为供试品。另取赤芍对照药材0.5g,加乙醇30ml,超声20min。滤过,滤液蒸至1ml即得对照药材溶液。另取芍药苷对照品,加乙醇制成每1ml含2mg的溶液,作为对照品溶液。按照薄层色谱法(2015版《中国药典》通则0502)进行试验。分别吸取上述供试品、阴性样品、对照对照品溶液5μl,对照药材溶液2μl,点于同一硅胶G薄层板上,以氯仿-醋酸乙酯-甲醇-甲酸(40∶5∶10∶0.2)为展开剂,展开,取出,晾干,喷以5%香草醛硫酸溶液,60℃加热至斑点显色清晰。在供试品色谱中,在与对照品、对照药材色谱相应的位置上显相同颜色的斑点,阴性对照在相应位置上无斑点。
HPLC含量测定方法包括以下步骤:
1)色谱条件:以十八烷基硅烷键合硅胶为填充剂;以乙腈和0.2%磷酸溶液为流动相进行梯度洗脱,流动相中乙腈水溶液的体积比分别为:0-40min,乙腈10-40%;40-45min,乙腈40-70%;45-50min,乙腈70%;50-55min,乙腈70-10%;55-60min,乙腈10%;检测波长为230nm,理论板数按黄芩苷计算应不低于2800。
2)对照品溶液的制备:取黄芩苷对照品适量,精密称定,加甲醇制成每1mL含140μg的对照品溶液。
3)供试品溶液的制备:取本品粉末约0.1g,精密称定,置具塞锥形瓶中,精密加入50%乙醇10ml,密塞,称定重量,超声处理(功率250W,频率40kHz)20分钟,放冷,再称定重量,用50%乙醇补足减失的重量,摇匀,滤过,取续滤液,即得。
4)测定法:分别精密吸取对照品溶液及供试品溶液各5μl,注入液相色谱仪,测定,记录色谱图,即得。
薄层鉴别详见图1-图3,含量测定色谱图见图4,含量测定相关数据详见下表2,各批次样品含量均≥10mg/g。
表2清肺达原颗粒黄芩苷含量测定数据
实施例4
收集黄石市各医院确诊患有新型冠状病毒肺炎患者54例,每位患者均在住院期间根据医生指导服用本发明的颗粒制剂,通过监测患者入院前后体温、血氧饱和度、白细胞计数、新型冠状病毒核酸、胸部CT等情况,评价清肺达原颗粒临床疗效,结果表明,54例患者服药5天内体温正常,核酸均逐步转阴,血样饱和度值不同程度提高,白细胞计数大部分恢复正常值(4-10),胸部CT提示大部分患者具有改善,充分说明清肺达原颗粒治疗新型冠状病毒肺炎临床效果显著,详见下表3。
表3临床疗效观察
以上所述实施例仅表达了本发明的实施方式,其描述较为具体和详细,但并不能因此而理解为对本发明专利范围的限制。应当指出的是,对于本领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干变形和改进,这些都属于本发明的保护范围。因此,本发明专利的保护范围应以所附权利要求为准。
Claims (2)
1.一种治疗新型冠状病毒肺炎的颗粒剂的制备方法,其特征在于,所述颗粒剂由如下重量份中药制成:柴胡20份、黄芩10份、法半夏10份、全瓜蒌10份、党参15份、槟榔10份、草果15份、厚朴15份、知母10份、赤芍10份、生甘草10份、陈皮10份、虎杖10份;
所述制备方法为:按重量比称取处方药材,加水提取2次,第一次加8倍量水,提取120分钟,并收集挥发油,第二次加6倍量水,提取45分钟,合并两次提取液,提取液进行120目滤过, 60-80℃浓缩至相对密度为1.05~1.20的浸膏,干燥,加入4-8倍β环糊精和辅料后制备成颗粒剂;所述干燥为喷雾干燥,喷雾干燥设备参数为引风机频率40Hz~50Hz,雾化器频率40Hz~50Hz,进风温度150-170℃。
2.根据权利要求1所述的制备方法,其特征在于,辅料包括糊精、糖粉、聚维酮、聚乙二醇和木糖醇中的一种或数种组合。
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN202010393600.4A CN111467451B (zh) | 2020-05-11 | 2020-05-11 | 一种治疗新型冠状病毒肺炎的组合物、制剂及其应用 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN202010393600.4A CN111467451B (zh) | 2020-05-11 | 2020-05-11 | 一种治疗新型冠状病毒肺炎的组合物、制剂及其应用 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN111467451A CN111467451A (zh) | 2020-07-31 |
CN111467451B true CN111467451B (zh) | 2021-03-05 |
Family
ID=71763155
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN202010393600.4A Active CN111467451B (zh) | 2020-05-11 | 2020-05-11 | 一种治疗新型冠状病毒肺炎的组合物、制剂及其应用 |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN111467451B (zh) |
Families Citing this family (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN112370515A (zh) * | 2020-09-03 | 2021-02-19 | 云南省中医医院(云南中医药大学第一附属医院) | 一种具有治疗时疫感冒的清瘟解热中药合剂、制备方法及用途 |
WO2021205196A1 (en) * | 2020-12-30 | 2021-10-14 | Muhammad Taliah | Compositions and prevention and intervention methods for covid-19 with divine ayats' fitra30 covid-19 protocol |
CN113181124A (zh) * | 2021-05-21 | 2021-07-30 | 劲牌持正堂药业有限公司 | 一种中成药颗粒组合物在制备抗呼吸道病毒药物中的应用 |
CN114796430A (zh) * | 2022-04-21 | 2022-07-29 | 丁佳胜 | 一种对2019新型冠状病毒具有防治效果的中药配方 |
CN115097032B (zh) * | 2022-06-17 | 2023-07-25 | 劲牌持正堂药业有限公司 | 一种uhplc特征图谱联合多指标成分含量测定控制清肺达原颗粒质量的方法 |
Family Cites Families (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN110870402B (zh) * | 2020-02-06 | 2020-07-17 | 葛又文 | 一种治疗新型冠状病毒感染的肺炎的中药复方及其应用 |
-
2020
- 2020-05-11 CN CN202010393600.4A patent/CN111467451B/zh active Active
Also Published As
Publication number | Publication date |
---|---|
CN111467451A (zh) | 2020-07-31 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
CN111467451B (zh) | 一种治疗新型冠状病毒肺炎的组合物、制剂及其应用 | |
CN102416139B (zh) | 一种用于治疗乳腺疾病的中药组合物 | |
ZA200302647B (en) | Novel medicinal herbal composition for treating liver diseases. | |
KR20040012447A (ko) | Hiv/aids 환자 치료용 약초성 약제학적 조성물 | |
AU2015345884B2 (en) | Drug or health care product preventing or treating liver and kidney damage-related diseases and use thereof | |
CN101966244A (zh) | 无糖型抗感解毒颗粒的制备方法 | |
CN104688688A (zh) | 一种包含治疗鼻炎的口服用药药效成分的气雾剂前体及将其分散成纳米级雾滴的方法 | |
CN106620610A (zh) | 一种甘草泻心颗粒的制备方法 | |
CN104771702B (zh) | 一种治疗脂肪肝和脂肪性肝炎的中药组合物的制备方法 | |
CN101041010A (zh) | 一种治疗消渴(糖尿病)的药物组合物及制备方法 | |
CN101062347A (zh) | 心脑通中药配方 | |
CN103316074B (zh) | 一种花锚提取物、黄芪提取物与甘草提取物的组合药物及其制剂、应用 | |
CN115184492A (zh) | 清金益气颗粒指纹图谱建立方法及其成分含量测定方法 | |
CN101199669A (zh) | 治疗男性精子质量低下的中药复方制剂 | |
CN103961582B (zh) | 治疗肾炎的中药组合物及其制剂和制备方法 | |
CN102940724A (zh) | 一种用于消炎的中药复方胶囊的制备方法 | |
CN113237990A (zh) | 一种中药组合物中甘草成分的鉴定方法 | |
CN100361650C (zh) | 一种障眼明胶囊及其制备工艺 | |
CN104958662A (zh) | 治疗脂肪性肝炎合并高脂血症的中药组合物及其制备方法 | |
CN111729052A (zh) | 一种中药组合物、制备方法和在制备清热解毒药物方面的用途 | |
CN103100015B (zh) | 一种治疗呼吸系统疾病的药物及其制备方法、应用 | |
CN100571728C (zh) | 一种制备万通筋骨片的方法 | |
CN108030817B (zh) | 一种乙肝舒康胶囊的制备方法 | |
CN115025158A (zh) | 一种异功散提取物和应用 | |
CN106491747B (zh) | 虫草芪参胶囊的制备及质量标准检测方法 |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
PB01 | Publication | ||
PB01 | Publication | ||
SE01 | Entry into force of request for substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
GR01 | Patent grant | ||
GR01 | Patent grant |