WO2021179505A1 - 一种翘芪复方制剂及其制备方法和用途 - Google Patents

一种翘芪复方制剂及其制备方法和用途 Download PDF

Info

Publication number
WO2021179505A1
WO2021179505A1 PCT/CN2020/101945 CN2020101945W WO2021179505A1 WO 2021179505 A1 WO2021179505 A1 WO 2021179505A1 CN 2020101945 W CN2020101945 W CN 2020101945W WO 2021179505 A1 WO2021179505 A1 WO 2021179505A1
Authority
WO
WIPO (PCT)
Prior art keywords
parts
preparation
astragalus
compound preparation
forsythia
Prior art date
Application number
PCT/CN2020/101945
Other languages
English (en)
French (fr)
Inventor
顾晓松
汤淳康
龚蕾蕾
张愉
程琼
杨晓明
王晓敏
Original Assignee
尧舜泽生物医药(南京)有限公司
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by 尧舜泽生物医药(南京)有限公司 filed Critical 尧舜泽生物医药(南京)有限公司
Priority to KR1020227017189A priority Critical patent/KR20220098360A/ko
Priority to JP2022539138A priority patent/JP2023508675A/ja
Priority to EP20924142.1A priority patent/EP4066848A4/en
Priority to US17/788,010 priority patent/US20230040479A1/en
Publication of WO2021179505A1 publication Critical patent/WO2021179505A1/zh

Links

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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/235—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids having an aromatic ring attached to a carboxyl group
    • 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
    • A61K36/238—Saposhnikovia
    • 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)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/282—Artemisia, e.g. wormwood or sagebrush
    • 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)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/284—Atractylodes
    • 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)
    • A61K36/35—Caprifoliaceae (Honeysuckle family)
    • A61K36/355—Lonicera (honeysuckle)
    • 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
    • A61K36/481—Astragalus (milkvetch)
    • 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
    • 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
    • A61K36/532—Agastache, e.g. giant hyssop
    • 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)
    • A61K36/63—Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
    • A61K36/634—Forsythia
    • 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
    • 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
    • A61K36/8968—Ophiopogon (Lilyturf)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • 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
    • A61P31/16—Antivirals for RNA viruses for influenza or rhinoviruses
    • 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
    • A61K2236/10—Preparation or pretreatment of starting material
    • 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
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Definitions

  • the invention relates to a Qiqi compound preparation, a preparation method and application thereof, and belongs to the technical field of medicine.
  • Influenza (abbreviated as influenza) is mainly a respiratory infection caused by influenza virus, which is highly contagious and spreads quickly.
  • the typical clinical symptoms are: fever, headache, sore limbs, sneezing, dry throat, sore throat, cough, fatigue.
  • influenza epidemic endangers the public health safety of the society and endangers the health of the people. Therefore, the development of new drugs for viral influenza is a major demand in today's society and a major need for people's health.
  • the present invention provides a Qiqi compound preparation and its preparation method and application.
  • a Qiqi compound preparation including Chinese medicine formula components
  • the Chinese medicine formula components are composed of the following parts by mass of raw materials or raw material extracts: 9-11 parts of honeysuckle, 9-11 parts of Forsythia, 9-11 parts of Scutellaria baicalensis Georgi, 9-11 parts of Artemisia annua, 9-11 parts of Raw Astragalus, 9-11 parts of Fried Atractylodes, 9-11 parts of Huoxiang, 5-7 parts of Parsnip, 9-11 parts of Ophiopogon japonicus, 5-11 parts of Licorice 7 servings.
  • the components of the Chinese medicine formula are composed of the following parts by mass: 10 parts of honeysuckle, 10 parts of forsythia, 10 parts of scutellaria, 10 parts of artemisia annua, 10 parts of raw astragalus , Fried Atractylodes macrocephala 10 parts, Huoxiang 10 parts, Fangfeng 6 parts, Ophiopogon japonicus 10 parts, Licorice 6 parts.
  • the Qiqi compound preparation includes an effective dose of the traditional Chinese medicine formula components and pharmaceutically acceptable excipients.
  • the dosage form of the Qiaoqi compound preparation includes oral liquid, granules, granules, and tablets.
  • a preparation method of Aoqi oral liquid including:
  • a preparation method of Qiaoqi granules including:
  • the application of the Astragalus compound preparation in the preparation of drugs for the prevention and/or treatment of viral influenza diseases is provided.
  • the monarch medicine of this prescription honeysuckle, forsythia, scutellaria, artemisia annua; minister medicine: astragalus, fried atractylodes, huoxiang; adjuvant: parsnip, Ophiopogon japonicus; making medicine, licorice.
  • This prescription is: clearing away heat and detoxification, inhibiting virus vitality, nourishing yin and calming cough, nourishing the lungs and spleen, strengthening the body and clearing the plague. It is suitable for influenza, fever, headache, sore limbs, sore throat, cough, fatigue.
  • a Qiaoqi compound preparation and its preparation method and application provided by the present invention are compared with the existing traditional Chinese medicines such as Zhengchaihuyin granules, Ban GmbH granules, Lianhua Qingwen capsules, Shuanghuanglian oral liquid, etc.: 1.
  • the composition of the medicine of this prescription is different from the existing related Chinese medicines, and the composition of the medicine is unique and novel; 2.
  • the innovative point of the efficacy of this medicine is that through the composition of the medicine formula, it produces a strong combined antiviral effect of the drug and improves the immune function of the human body. , To achieve a better integrated and synergistic antiviral effect.
  • honeysuckle, forsythia, and scutellaria have antiviral effects.
  • This recipe uses three Chinese medicines in combination to enhance the antiviral effect of the drugs.
  • the astragalus and licorice in this recipe can play a better role by regulating the immune function of the human body. Integrating synergistic antiviral effects, by effectively inhibiting the vitality of the virus, alleviating the symptoms of patients, and achieving the effect of strengthening the body and removing the evil; 3.
  • the unique innovation in the theory of dialectical treatment of influenza Yin Ning cough, nourishing the lungs and spleen, strengthening the body and clearing the plague".
  • honeysuckle, forsythia, scutellaria, artemisia annua enter the lung, stomach, liver, gallbladder, and large intestine meridian, and have the effects of clearing heat and detoxification, and clearing lungs and cough; astragalus, fried atractylodes, and huoxiang have the effects of invigorating the spleen and enhancing the body's resistance; Compatibility of Fangfeng with Astragalus and Atractylodes, namely Yupingfeng Powder, has the function of replenishing qi, strengthening the body's immune function, strengthening the body's immune function, and strengthening the body's vitality; Artemisia annua reduces fever, Huoxiang aroma and turbidity, clearing lungs and Ning cough; Ophiopogon japonicus nourishes Yin produces body fluid, nourishes the lungs and relieves cough; licorice nourishes the spleen and nourishes
  • the original ingredients are as follows: 100 parts of honeysuckle, 100 parts of Forsythia, 100 parts of Scutellaria baicalensis, 100 parts of Artemisia annua, 100 parts of Raw Astragalus, 100 parts of Fried Atractylodes, 100 parts of Huoxiang, 60 parts of Parsnip, 100 parts of Ophiopogon japonicus, 60 parts of Licorice .
  • the original ingredients are as follows: 100 parts of honeysuckle, 100 parts of Forsythia, 100 parts of Scutellaria baicalensis, 100 parts of Artemisia annua, 100 parts of Raw Astragalus, 100 parts of Fried Atractylodes, 100 parts of Huoxiang, 60 parts of Parsnip, 100 parts of Ophiopogon japonicus, 60 parts of Licorice .
  • Example 3 Effect of Qiaoqi granules on lung lesions in mice infected with influenza virus
  • mice were randomly divided into 4 groups, each with 6 mice, including normal group, model group, ribavirin group, and Qiaoqi granule group. Gavage was administered twice a day, 0.3 ml each time, and the normal group was given the same dose of double distilled water for 5 consecutive days. Viral allantoic fluid was used to infect the nasal cavity with 15 LD50 challenge per mouse. On the 6th day, the mice were sacrificed by removing the cervical vertebrae, fixed in 10% formaldehyde solution, conventionally obtained materials, dehydrated, embedded in paraffin, HE stained, and read under a light microscope. According to the different degrees of the severity of the lesion, the values were assigned as 0, 1, 2, 3, and 4, and the lesion score was calculated and statistically analyzed. The rank sum test was used, and the statistical software SPSS13.0 was used.
  • Clinical efficacy criteria within 3 days of continuous medication, the body temperature returned to normal, the symptoms of headache, sore limbs, dry throat, sore throat, and cough were significantly relieved, the blood picture was normal, and the chest X-ray image was normal. Combining marked effect and relief into effective, the effective rate reached 87%.

Abstract

一种翘芪复方制剂及其制备方法以及该翘芪复方制剂在制备预防和/或治疗病毒性流行性感冒疾病的药物中的应用，该翘芪复方制剂可制成口服液、颗粒剂、冲剂、片剂，其组方由以下质量份数的原料或原料提取物组成：金银花9-11份、连翘9-11份、黄芩9-11份、青蒿9-11份、生黄芪9-11份、炒白术9-11份、藿香9-11份、防风5-7份、麦冬9-11份、甘草5-7份。

Description

一种翘芪复方制剂及其制备方法和用途 技术领域
本发明涉及一种翘芪复方制剂及其制备方法和用途，属于医药技术领域。
背景技术
流行性感冒(简称流感)主要是由流感病毒引起的呼吸道感染，其传染性强、传播速度快。典型的临床症状是：发热，头痛，四肢酸痛，打喷嚏，咽干燥，咽痛，咳嗽，乏力。
目前临床上针对流感治疗无特效药，流感流行危害着社会公共卫生安全，危害着人民的健康，因此，研发针对病毒性流行性感冒的新药是当今社会的重大需求，也是民生健康的重大需求。
发明内容
目的：为解决现有技术的不足，本发明提供一种翘芪复方制剂及其制备方法和用途。
技术方案：为解决上述技术问题，本发明采用的技术方案为：
第一方面，提供一种翘芪复方制剂，包括中药配方组分，所述中药配方组分由以下质量份数的原料或原料提取物组成：金银花9-11份、连翘9-11份、黄芩9-11份、青蒿9-11份、生黄芪9-11份、炒白术9-11份、藿香9-11份、防风5-7份、麦冬9-11份、甘草5-7份。
作为优选方案，所述的翘芪复方制剂，所述中药配方组分由以下质量份数的组份组成：金银花10份、连翘10份、黄芩10份、青蒿10份、生黄芪10份、炒白术10份、藿香10份、防风6份、麦冬 10份、甘草6份。
在一些实施例中，所述的翘芪复方制剂，包括有效剂量的所述的中药配方组分，和药学上可接受的辅料。
在一些实施例中，翘芪复方制剂的剂型包括口服液、颗粒剂、冲剂、片剂。
第二方面，提供一种翘芪口服液的制备方法，包括：
(1)按照配方比例准备原料：金银花10份、连翘10份、黄芩10份、青蒿10份、生黄芪10份、炒白术10份、藿香10份、防风6份、麦冬10份、甘草6份；水冲洗药材，去杂质；
(2)用去离子水浸泡，25℃，120分钟；
(3)水提，100℃，煎20分钟；
(4)取煎液，4℃，静置12小时，滤过，浓缩，添加苯甲酸或苯甲酸钠；
(5)灌封，灭菌，即得。
第三方面，提供一种翘芪颗粒的制备方法，包括：
(1)按照配方比例准备原料：金银花10份、连翘10份、黄芩10份、青蒿10份、生黄芪10份、炒白术10份、藿香10份、防风6份、麦冬10份、甘草6份；水冲洗药材，去杂质；
(2)用去离子水浸泡，25℃，120分钟；
(3)水提，100℃，煎20分钟；
(4)取煎液，4℃，静置12小时，滤过，浓缩，添加苯甲酸或苯甲酸钠；
(5)干燥，制粒，封装，灭菌即得。
第四方面，提供所述的翘芪复方制剂在制备预防和/或治疗病毒性流行性感冒疾病的药物中的应用。
本方君药：金银花、连翘、黄芩、青蒿；臣药：黄芪、炒白术、藿香；佐药：防风、麦冬；使药，甘草。
本方功能是：清热解毒，抑制病毒活力，养阴宁咳，益肺补脾，扶正清瘟。适用于流行性感冒，发热，头痛，四肢酸痛，咽痛，咳嗽，乏力。
有益效果：本发明提供的一种翘芪复方制剂及其制备方法和用途，与现有的正柴胡饮颗粒、板蓝根颗粒、连花清瘟胶囊、双黄连口服液等中药相比：一、本方药物组成成分与现有的相关中药不同，药物配方组成独特新颖；二、本方药物功效的创新点在于，通过药物配方组成，产生较强的药物联合抗病毒作用，同时提升人体免疫功能，达到较好的整合协同抗病毒作用。例如，金银花、连翘、黄芩单味药均有抗病毒作用，本方是采用三味中药联合使用，增强药物抗病毒作用，同时本方中的黄芪、甘草可通过调节人体免疫功能发挥更好的整合协同抗病毒作用，通过有效抑制病毒活力，缓解患者症状，达到扶正祛邪功效；三、本方辩证施治流感的理论独特创新，其创新点是在传统的清热解毒基础上，提出“养阴宁咳，益肺补脾，扶正清瘟”。例如，金银花、连翘、黄芩、青蒿，入肺胃肝胆大肠经，具有清热解毒，清肺宁咳的功效；黄芪、炒白术、藿香，具有补气益脾功效，增强人体抵抗能力；防风与黄芪、白术配伍，即玉屏风散，具有益气、固表、 增强人体免疫功能，起着扶正固元作用；青蒿退热，藿香芳香化浊，清肺宁咳；麦冬养阴生津，润肺止咳；甘草补脾益气，清热解毒，调和诸药，发挥协同功效。
具体实施方式
下面结合实施例对本发明做具体说明：
实施例1：翘芪口服液制备
原方配料如下：金银花100份、连翘100份、黄芩100份、青蒿100份、生黄芪100份、炒白术100份、藿香100份、防风60份、麦冬100份、甘草60份。
制备方法与步骤：
(1)水冲洗药材，去杂质；
(2)配制成1000体积份，用去离子水浸泡，25℃，120分钟；
(3)水提，100℃，煎20分钟；
(4)取煎液，4℃，静置12小时，滤过，浓缩，添加苯甲酸或苯甲酸钠；
(5)灌封，灭菌，即得。
实施例2：翘芪颗粒制备
原方配料如下：金银花100份、连翘100份、黄芩100份、青蒿100份、生黄芪100份、炒白术100份、藿香100份、防风60份、麦冬100份、甘草60份。
制备方法与步骤：
(1)水冲洗药材，去杂质；
(2)配制成1000体积份，用去离子水浸泡，25℃，120分钟；
(3)水提，100℃，煎20分钟；
(4)取煎液，4℃，静置12小时，滤过，浓缩，添加苯甲酸或苯甲酸钠；
(5)干燥，制粒，封装，灭菌即得。
实施例3：翘芪颗粒对流感病毒感染小鼠肺病变的影响
材料：翘芪颗粒配成原液(15.6g生药/kg)；利巴韦林(阳性对照药，0.075g/kg)；鸡胚，甲型流感病毒FM1株，ICR小鼠。
方法：将小鼠随机分4组，每组6只，设正常组、模型组、利巴韦林组、翘芪颗粒组。每天2次灌胃给药，每次0.3毫升，正常组给同剂量双蒸水，连续5天。以病毒尿囊液滴鼻腔感染，每鼠15个LD50攻击量。第6天，将小鼠脱颈椎处死，10％甲醛液固定，常规取材，脱水，石蜡包埋，HE染色，光镜下阅片。根据病变轻中重不同程度分别赋值为0、1、2、3、4，计算出病变评分并作统计学分析。采用秩和检验，所用的统计软件SPSS13.0。
结果：
表翘芪颗粒对流感病毒感染小鼠肺病变程度的影响(n＝6)
Figure PCTCN2020101945-appb-000001
Figure PCTCN2020101945-appb-000002
注：(1)不同的组织病变中，模型组、利巴韦林组、翘芪颗粒组与正常组相比其差别多有统计学意义(P<0.05)。(2)利巴韦林组与翘芪颗粒组之间的差别无统计学意义(P>0.05)。
结果表明：翘芪颗粒具有减轻流感病毒引起小鼠肺部病变的作用。
实施例4：
一般资料，2019年9月至2020年2月，对临床流行性感冒患者，符合下列症状(发热、头痛、四肢酸痛、咽干、咽痛、咳嗽)入组用翘芪颗粒冲剂口服治疗，30例患者，年龄19-60岁，每天一剂中药，分早晚两次口服，连服3-5天。对照组30例，设开放平行、常规治疗对照。
临床疗效标准：连续服药3天内，体温恢复至正常，头痛、四肢酸痛、咽干、咽痛、咳嗽的症状明显缓解，血象正常，胸片影像正常。将显效和缓解合并为有效，有效率达到87％。
以上已以较佳实施例公开了本发明，然其并非用以限制本发明，凡采用等同替换或者等效变换方式所获得的技术方案，均落在本发明的保护范围之内。

Claims (7)

  1. 一种翘芪复方制剂，其特征在于，包括中药配方组分，所述中药配方组分由以下质量份数的原料或原料提取物组成：金银花9-11份、连翘9-11份、黄芩9-11份、青蒿9-11份、生黄芪9-11份、炒白术9-11份、藿香9-11份、防风5-7份、麦冬9-11份、甘草5-7份。
  2. 根据权利要求1所述的翘芪复方制剂，其特征在于，所述中药配方组分由以下质量份数的组份组成：金银花10份、连翘10份、黄芩10份、青蒿10份、生黄芪10份、炒白术10份、藿香10份、防风6份、麦冬10份、甘草6份。
  3. 根据权利要求1或2所述的翘芪复方制剂，其特征在于，包括有效剂量的所述的中药配方组分，和药学上可接受的辅料。
  4. 根据权利要求3所述的翘芪复方制剂，其特征在于，翘芪复方制剂的剂型包括口服液、颗粒剂、冲剂、片剂。
  5. 一种翘芪口服液的制备方法，其特征在于，包括：
    (1)按照配方比例准备原料：金银花10份、连翘10份、黄芩10份、青蒿10份、生黄芪10份、炒白术10份、藿香10份、防风6份、麦冬10份、甘草6份；水冲洗药材，去杂质；
    (2)用去离子水浸泡，25℃，120分钟；
    (3)水提，100℃，煎20分钟；
    (4)取煎液，4℃，静置12小时，滤过，浓缩，添加苯甲酸或苯甲酸钠；
    (5)灌封，灭菌，即得。
  6. 一种翘芪颗粒的制备方法，其特征在于，包括：
    (1)按照配方比例准备原料：金银花10份、连翘10份、黄芩10份、青蒿10份、生黄芪10份、炒白术10份、藿香10份、防风6份、麦冬10份、甘草6份；水冲洗药材，去杂质；
    (2)用去离子水浸泡，25℃，120分钟；
    (3)水提，100℃，煎20分钟；
    (4)取煎液，4℃，静置12小时，滤过，浓缩，添加苯甲酸或苯甲酸钠；
    (5)干燥，制粒，封装，灭菌即得。
  7. 权利要求1-4任一项所述的翘芪复方制剂在制备预防和/或治疗病毒性流行性感冒疾病的药物中的应用。
PCT/CN2020/101945 2020-03-12 2020-07-14 一种翘芪复方制剂及其制备方法和用途 WO2021179505A1 (zh)

Priority Applications (4)

Application Number Priority Date Filing Date Title
KR1020227017189A KR20220098360A (ko) 2020-03-12 2020-07-14 개나리-황기 복방제제 및 그 제조방법과 용도
JP2022539138A JP2023508675A (ja) 2020-03-12 2020-07-14 レンギョウとオウギによる複方製剤及びその製造方法並びに用途
EP20924142.1A EP4066848A4 (en) 2020-03-12 2020-07-14 PREPARATION OF A COMPOUND OF FORSYTHIA SUSPENSA AND ASTRAGALUS MEMBRANACEUS, PROCESS FOR THEIR PREPARATION AND ITS USE
US17/788,010 US20230040479A1 (en) 2020-03-12 2020-07-14 Fructus forsythiae and radix astragali compound preparation, and preparation method therefor and use thereof

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202010168799.0 2020-03-12
CN202010168799.0A CN111249390A (zh) 2020-03-12 2020-03-12 一种翘芪复方制剂及其制备方法和用途

Publications (1)

Publication Number Publication Date
WO2021179505A1 true WO2021179505A1 (zh) 2021-09-16

Family

ID=70945818

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2020/101945 WO2021179505A1 (zh) 2020-03-12 2020-07-14 一种翘芪复方制剂及其制备方法和用途

Country Status (6)

Country Link
US (1) US20230040479A1 (zh)
EP (1) EP4066848A4 (zh)
JP (1) JP2023508675A (zh)
KR (1) KR20220098360A (zh)
CN (1) CN111249390A (zh)
WO (1) WO2021179505A1 (zh)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111249390A (zh) * 2020-03-12 2020-06-09 尧舜泽生物医药(南京)有限公司 一种翘芪复方制剂及其制备方法和用途
CN113577140A (zh) * 2021-07-28 2021-11-02 黑龙江中医药大学附属第一医院（黑龙江中医药大学第一临床医学院） 一种用于治疗新冠肺炎的中药组合物及其制备方法与应用
CN113925835A (zh) * 2021-09-29 2022-01-14 孙鲁英 固表清肺颗粒及其制备方法
CN114606236B (zh) * 2022-04-21 2024-01-05 南通大学 一种翘芪复方中药汤剂来源的微小核糖核酸及其制备方法和应用

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101574407A (zh) * 2009-06-24 2009-11-11 贾高增 一种预防感冒的药物及其制备方法
CN101816752A (zh) * 2009-02-26 2010-09-01 河南天纳图生物科技有限公司 预防治疗禽流感的中药
CN104013678A (zh) * 2014-05-24 2014-09-03 潍坊市富言畜禽病诊疗中心 一种用于防治禽流感、新城疫的中药组合物及使用所述组合物养殖肉鸡的方法
CN104740370A (zh) * 2013-12-26 2015-07-01 孔辉 一种预防和治疗禽流感的药物
CN111249390A (zh) * 2020-03-12 2020-06-09 尧舜泽生物医药(南京)有限公司 一种翘芪复方制剂及其制备方法和用途

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101708275B (zh) * 2009-11-27 2012-11-28 北京市卫生局临床药学研究所 一种治疗由甲型h1n1等流感病毒引起的流感的中药
CN104840786B (zh) * 2015-05-14 2019-02-15 北京康华远景科技股份有限公司 一种预防禽流感的药物组合物及其制备方法
CN109939152A (zh) * 2017-12-20 2019-06-28 广东恒诚制药有限公司 一种感冒止咳颗粒的制备方法及应用

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101816752A (zh) * 2009-02-26 2010-09-01 河南天纳图生物科技有限公司 预防治疗禽流感的中药
CN101574407A (zh) * 2009-06-24 2009-11-11 贾高增 一种预防感冒的药物及其制备方法
CN104740370A (zh) * 2013-12-26 2015-07-01 孔辉 一种预防和治疗禽流感的药物
CN104013678A (zh) * 2014-05-24 2014-09-03 潍坊市富言畜禽病诊疗中心 一种用于防治禽流感、新城疫的中药组合物及使用所述组合物养殖肉鸡的方法
CN111249390A (zh) * 2020-03-12 2020-06-09 尧舜泽生物医药(南京)有限公司 一种翘芪复方制剂及其制备方法和用途

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP4066848A4 *

Also Published As

Publication number Publication date
JP2023508675A (ja) 2023-03-03
KR20220098360A (ko) 2022-07-12
EP4066848A1 (en) 2022-10-05
US20230040479A1 (en) 2023-02-09
CN111249390A (zh) 2020-06-09
EP4066848A4 (en) 2023-01-04

Similar Documents

Publication Publication Date Title
WO2021179505A1 (zh) 一种翘芪复方制剂及其制备方法和用途
CN111388582B (zh) 一种用于新型冠状病毒肺炎的中药组合物及其制剂的应用
CN111317798A (zh) 解毒化湿利咽中药组合物及其应用
WO2021208336A1 (zh) 中药组合物及其应用
CN111388615A (zh) 一种防治肺炎的中药合剂及其制备方法
CN116139237B (zh) 一种防治新型冠状病毒等所致呼吸道感染的中药组合物及其应用
CN111840456A (zh) 用于治疗呼吸系统疾病的中药组合物
CN102861189A (zh) 一种治疗病毒性脑炎的中药组合物
AU2021106785B4 (en) Combined plant compounds for use in the treatment of viral infections including covid-19
CN101926903A (zh) 用于治疗面神经麻痹的中药制剂
CN115486488A (zh) 一种用于普通食品的茶饮组合物及其应用
CN102784307B (zh) 一种用于治疗肺结核的中药及制备方法
CN111544466B (zh) 一种中药组合物及其在制备预防新冠肺炎的药物中的应用
CN101884762B (zh) 一种治疗肺气肿的中药
CN100333777C (zh) 改善放化疗后肠胃功能的药物
CN104274582B (zh) 一种用于护肝的药物组合物及其制备方法
CN117281871A (zh) 一种治疗呼吸道传染病的中药复方和应用
CN113577200A (zh) 一种治疗肺结核的药物组合物
CN114246892A (zh) 一种治疗急性咽喉炎、急性扁桃体炎的中药组合物及其制备方法
CN113797307A (zh) 一种慢性肠胃炎用中药制剂、制备方法及其服用方法
CN111228432A (zh) 一种治疗病毒性感冒的中药组合物及其制备和应用
CN115400077A (zh) 海龙蛤蚧口服液在制备治疗过敏性鼻炎药物中的应用
CN116585382A (zh) 一种利于病毒感染肺炎的康复中药制剂
CN115487285A (zh) 一种用于治疗由心阴不足引起抑郁的中药组合物
CN102940792A (zh) 一种治疗风温的中药组合物

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 20924142

Country of ref document: EP

Kind code of ref document: A1

ENP Entry into the national phase

Ref document number: 20227017189

Country of ref document: KR

Kind code of ref document: A

ENP Entry into the national phase

Ref document number: 2022539138

Country of ref document: JP

Kind code of ref document: A

ENP Entry into the national phase

Ref document number: 2020924142

Country of ref document: EP

Effective date: 20220629

NENP Non-entry into the national phase

Ref country code: DE