WO2021227614A1 - 一种用于清肺化纤的药物组合物及其用途 - Google Patents

一种用于清肺化纤的药物组合物及其用途 Download PDF

Info

Publication number
WO2021227614A1
WO2021227614A1 PCT/CN2021/079261 CN2021079261W WO2021227614A1 WO 2021227614 A1 WO2021227614 A1 WO 2021227614A1 CN 2021079261 W CN2021079261 W CN 2021079261W WO 2021227614 A1 WO2021227614 A1 WO 2021227614A1
Authority
WO
WIPO (PCT)
Prior art keywords
parts
pharmaceutical composition
raw
chemical fiber
lung
Prior art date
Application number
PCT/CN2021/079261
Other languages
English (en)
French (fr)
Inventor
张莹雯
Original Assignee
张莹雯
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 张莹雯 filed Critical 张莹雯
Publication of WO2021227614A1 publication Critical patent/WO2021227614A1/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
    • A61K36/17—Gnetophyta, e.g. Ephedraceae (Mormon-tea family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56—Materials from animals other than mammals
    • A61K35/63—Arthropods
    • A61K35/64—Insects, e.g. bees, wasps or fleas
    • 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)
    • A61K36/31—Brassicaceae or Cruciferae (Mustard family), e.g. broccoli, cabbage or kohlrabi
    • 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)
    • A61K36/36—Caryophyllaceae (Pink family), e.g. babysbreath or soapwort
    • 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)
    • 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
    • A61K36/532—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)
    • A61K36/65—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
    • A61K36/708—Rheum (rhubarb)
    • 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)
    • A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A61K36/736—Prunus, e.g. plum, cherry, peach, apricot or almond
    • 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
    • A61K36/8966—Fritillaria, e.g. checker lily or mission bells
    • 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)
    • A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
    • 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

Definitions

  • the invention relates to a traditional Chinese medicine composition, in particular to a medicine composition for clearing lungs and chemical fiber and its use.
  • Pulmonary fibrosis is a common pathological change of a variety of chronic lung diseases, which can be caused by many factors such as smoking, viral infection, environmental pollution, genetic susceptibility and drugs, and its main feature is the inflammatory exudation of the lung interstitium leading to fibroblasts Excessive proliferation, deposition of collagen in the lungs, destruction of the alveolar structure, and progressive decline in lung function. Mild pulmonary fibrosis is mainly manifested as exertional dyspnea, and in severe cases, it develops into progressive dyspnea. Most advanced patients die due to cardiopulmonary failure, which seriously affects the quality of life of patients. At present, the pathogenesis of pulmonary fibrosis is not clear, and there is a lack of effective therapeutic drugs in clinical practice, and the prognosis is poor.
  • New coronavirus pneumonia (COVID-19) is a pneumonia caused by a new coronavirus (2019-nCOV) infection. Based on previous studies, it is believed that patients with severe SARS-COV and MERS-COV infections have a large number of pulmonary interstitial inflammation in the acute phase. Exudation can cause severe pulmonary fibrosis, and the anatomy of patients who died from COVID-19 found that the main risk factor was the formation of phlegm thrombi in the mucus in the small airways, which hindered airway patency, not pulmonary interstitial fibrosis.
  • lung imaging of a large number of severe and critical COVID-19 patients showed obvious pulmonary interstitial fibrosis, indicating that 2019-nCOV infection may also cause pulmonary fibrosis changes and cause irreversible damage.
  • glucocorticoid therapy, oxygen therapy and blood purification have been shown to inhibit pulmonary inflammation and reduce the mortality rate, there is no effective evidence to improve pulmonary fibrosis.
  • nintedanib and pirfenidone have been approved by the Food and Drug Administration (FDA) for the treatment of mild to moderate idiopathic pulmonary fibrosis, these two drugs are only It can delay the progression of pulmonary fibrosis, but cannot reverse the pathological changes of fibrosis, and cannot completely prevent the decline of the patient's lung function.
  • FDA Food and Drug Administration
  • the purpose of the present invention is to solve the problem of pulmonary fibrosis, and provide a traditional Chinese medicine composition for clearing lungs and chemical fiber, which has the effects of detoxification, relieving asthma, removing blood stasis and dredging collaterals, solving the problem of pulmonary fibrosis, and is especially suitable for new type of coronary pneumonia Treatment of critically ill patients.
  • the present invention provides a pharmaceutical composition for clearing lungs and chemical fiber, which is composed of the following components by weight: 6-10 parts of raw ephedra, 3-10 parts of licorice, almonds 9-12 parts, 15-20 parts of raw gypsum, 6-12 parts of Agastache vulgaris, 6-12 parts of Caoguo, 8-12 parts of Pinellia ternata, 3-6 parts of raw rhubarb, 10-15 parts of Radix Pseudostellariae, Tinglizi 10-15 parts, red peony 10-15 parts, betel nut 10-12 parts, Citrus aurantium 10-15 parts, stiff silkworm 15-20 parts, Zhejiang fritillary 15-20 parts, loofah 15-20 parts, reed root 8 -12 servings.
  • the green gypsum needs to be fried in advance.
  • the amount of the raw gypsum is 1.5-2.5 times that of the raw ephedra, based on the mass ratio.
  • the present invention also provides a use of the above-mentioned pharmaceutical composition for clearing lungs and chemical fiber in preparing a medicine for clearing lungs and chemical fiber.
  • the drug is used for anti-new coronavirus.
  • the medicament is a preparation prepared by using the above-mentioned pharmaceutical composition as an active ingredient, plus pharmaceutically acceptable excipients or auxiliary ingredients.
  • the active component comprises: powder, water extract or organic solvent extract of the pharmaceutical composition.
  • the preparation is powder, tablet, ointment, granule, capsule or oral liquid.
  • the formulation of the pharmaceutical composition of the present invention follows the principle of the monarch and the minister: raw gypsum, raw ephedra, fritillaria, and silkworm are used as the monarch medicine, and almonds, grass fruits, pinellia, ginseng, red peony, and loofah are used as ministers.
  • the medicine is adjuvanted with Agastache, Rhubarb, Tinglizi, Betel Nut, Fructus Aurantii, Reed Root, and Licorice.
  • the compatibility of the pharmaceutical composition of the present invention is as follows:
  • Ephedra is matched with gypsum. Ephedra has a pungent, slightly bitter taste, warm in nature, enters the lungs and bladder meridian, and sweats to relieve
  • Gypsum is pungent and sweet, and has a severe cold, enters the lungs and stomach meridians, and specifically relieves the fire in the lungs and stomach.
  • the two are compatible, one pungent temperature, one pungent cold, pungent cold is greater than pungent temperature, and the amount of gypsum is 1.5-2 times that of ephedra. It is a heavy dose of pungent and cool.
  • Ephedra Xuanfei relieves qi and relieves the surface
  • gypsum clears the lung and stomach stagnant heat, altogether makes the lung qi invigorate, clears heat, and relieves cough and asthma. It mainly treats fever and cough due to heat trapped in the lung and lung failure.
  • Fritillaria zheiensis is cold in nature, bitter in taste, and returns to the lung meridian. It mainly treats phlegm-heat, cough, carbuncle and other symptoms. Zhe Fritillaria, ephedra and gypsum have the effects of clearing heat and dispelling congestion, resolving phlegm and relieving cough. Tinglizi is cold in nature, pungent and bitter in taste, and returns to the lung and large intestine meridian. Its effect is to relieve the lung and relieve asthma. Almonds promote lung qi as a minister, combined with Tinglizi, to help ephedra to relieve cough and relieve asthma.
  • the stiff silkworm is salty, pungent, and flat, and belongs to the liver, lung, and stomach meridians.
  • Loofah is sweet in taste, cold in nature, and returns to the lung meridian.
  • Red peony is slightly cold in nature, bitter in taste, returns to the liver meridian, and is better than dispersing blood stasis and promoting blood circulation.
  • Stiff silkworm is combined with Zhejiang Fritillaria, Loofah, Taizishen, Red Paeoniae Rubra.
  • Reed root is cold in nature and sweet in taste. It enters the lungs and stomach meridians. Raw rhubarb has a bitter taste and returns to the spleen, stomach, large intestine and other meridians. It is longer than diarrhea heat toxin, breaks stagnation, and promotes blood stasis. According to the theory of "the lung and large intestine are external and internal", it is used to ventilate the internal organs and reduce lung qi to relieve cough and asthma. Licorice is sweet, calming, returning to the spleen, stomach, and lung meridian. It is better than clearing away heat and detoxifying, relieving cough, and reconciling middle and emergency.
  • Combination of various drugs has the effects of clearing lungs and detoxification, invigorating the spleen and relieving asthma, resolving phlegm and collaterals, removing blood stasis and collaterals, promoting the absorption of lung infection and exudation, and improving lung function.
  • the drugs that prevent the occurrence of pulmonary fibrosis are gypsum, ephedra, fritillaria, and silkworm.
  • the present invention uses specific compatible Chinese herbal medicines with the functions of clearing lungs and detoxification, invigorating the spleen and relieving asthma, resolving phlegm and removing congestion, and removing blood stasis and collaterals for severe patients with new coronary pneumonia, especially those with the functions of resolving phlegm, removing congestion, and removing blood stasis and collaterals
  • the combination of Zhe Fritillaria, Stiff Silkworm, Red Peony and Loofah has unexpected technical effects to prevent the occurrence of pulmonary fibrosis.
  • the pharmaceutical composition provided by the present invention mainly functions to relieve cough and asthma, promote the absorption and disappearance of pulmonary infection and exudative lesions, reduce the consolidation range, reduce the density, and prevent pulmonary fibrosis, and is especially suitable for severely ill patients with neocoronavirus.
  • the pharmaceutical composition for clearing lung and chemical fiber is composed of the following components in parts by weight: 6-10 parts of raw ephedra, 3-10 parts of licorice, 9-12 parts of almonds, 15-20 parts of raw gypsum, 6-12 parts of Huoxiang, 6-12 parts of Caoguo, 8-12 parts of French Pinellia, 3-6 parts of Raw Rhubarb, 10-15 parts of Radix Ginseng, 10-15 parts of Tinglizi, 10-15 parts of Red Peony , Betel nut 10-12 parts, Citrus aurantium 10-15 parts, Stiff silkworm 15-20 parts, Zhejiang fritillary 15-20 parts, loofah 15-20 parts, reed root 8-12 parts.
  • the pharmaceutical composition is appropriately increased or decreased within the range of the above formula according to the principle of compatibility, depending on the manifestation of different symptoms or the degree of symptoms.
  • the raw gypsum is pre-decocted.
  • the pre-decocting adopts the conventional decocting method of traditional Chinese medicine, such as adding water and decocting for 20 minutes.
  • Efficacy index [(integral before treatment-integral after treatment)/integral before treatment] ⁇ 100%.
  • the time for the new coronavirus nucleic acid to turn negative is 6-13 days, with an average of 8.5 days.
  • CT showed that before treatment, the lung lesions were mainly ground glass opacity (GGO) and GGO combined with consolidation, and most of the lungs were affected by multiple lung lobes at the same time.
  • Re-examination of lung CT within 2 weeks after taking the medicine showed that 79 cases (91.86%) of patients had lung lesions absorbed earlier, of which 7 cases were completely absorbed and 72 cases were partially absorbed. It is mainly manifested in the reduction of the number of lesions, the reduction of consolidation range, and the reduction of density.
  • the lung injury score was lower than before treatment, and the difference was statistically significant.
  • the pharmaceutical composition of the present invention has the clinical effects of reversing the progression of severe disease, reducing the mortality rate and improving the cure rate for the treatment of severe patients.
  • the pharmaceutical composition for clearing lung and chemical fiber provided by the present invention is suitable for lung clearing and chemical fiber treatment, and is particularly suitable for the treatment of severely ill patients infected with a new type of coronavirus.
  • the above-mentioned pharmaceutical composition is used as the active ingredient, plus pharmaceutically acceptable excipients or auxiliary ingredients to prepare a preparation.
  • the preparation can be a powder, tablet, ointment, granule, capsule or oral liquid.
  • the active ingredient includes: powder, water extract, or organic solvent extract of the pharmaceutical composition, and the organic solvent usually refers to ethanol.
  • the pharmaceutical composition for clearing lungs and chemical fiber uses specific compatible Chinese herbal medicines with the effects of clearing lungs and detoxification, invigorating the spleen, relieving asthma, removing phlegm, removing stagnation, and removing blood stasis and collaterals to improve new type of coronary pneumonia.
  • the symptoms of pulmonary fibrosis in severe patients, in particular, Zhe Fritillaria, Stiff silkworm, Red peony, and loofah, which have the effects of resolving phlegm, dispelling blood stasis and dredging collaterals, are used in combination to prevent the occurrence of pulmonary fibrosis. The less technical effect has better application prospects.

Landscapes

  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Botany (AREA)
  • Mycology (AREA)
  • Medical Informatics (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Insects & Arthropods (AREA)
  • Virology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Husbandry (AREA)
  • Inorganic Chemistry (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Pulmonology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Plant Substances (AREA)

Abstract

一种清肺化纤的药物组合物，按重量份计由下述组分组成：生麻黄6-10、甘草3-10、杏仁9-12、生石膏15-20、藿香6-12、草果6-12、法半夏8-12、生大黄3-6、太子参10-15、葶苈子10-15、赤芍10-15、槟榔10-12、枳实10-15、僵蚕15-20、浙贝母15-20、丝瓜络15-20、芦根8-12；该组合物用于新型冠状病毒肺炎重型患者，具有止咳喘，促进肺部感染、渗出的病灶吸收及消失，实变范围缩小，密度减低，防止肺纤维化发生的作用。

Description

一种用于清肺化纤的药物组合物及其用途 技术领域
本发明涉及中药组合物，具体涉及一种用于清肺化纤的药物组合物及其用途。
背景技术
肺纤维化是多种慢性肺部疾病的共同病理改变，可由吸烟、病毒感染、环境污染、遗传易感性和药物等多种因素引起，其主要特征为肺间质炎性渗出导致成纤维细胞过度增殖、肺部胶原蛋白沉积，而肺泡结构破坏，肺功能进行性下降。轻度肺纤维化主要表现为劳力性呼吸困难，严重时发展为进行性呼吸困难，晚期患者多因心肺功能衰竭而死亡，严重影响患者生活质量。目前对肺纤维化的发病机制尚不明确，临床上亦缺乏有效治疗药物，预后较差。
新型冠状病毒肺炎(COVID-19)是由新型冠状病毒(2019-nCOV)感染引起的肺炎，基于既往研究认为，SARS-COV和MERS-COV重症感染患者，由于急性期的大量肺间质炎性渗出，会造成严重的肺部纤维化，而对COVID-19死亡患者的解剖发现其主要危险因素为小气道中黏液形成痰栓，阻碍气道通畅，并非肺间质纤维化。但大量重症及危重症COVID-19患者肺部影像学提示了明显的肺间质纤维化表现，说明2019-nCOV感染亦可能引起肺纤维化改变，造成不可逆损伤。尽管糖皮质激素治疗、氧疗及血液净化等被证明可抑制肺部炎症反应，降低病死率，但能否改善肺纤维化尚无有效证据。此外，尼达尼布和吡非尼酮虽已被美国食品药品监督管理局(Food and drug administration，FDA)批准用于轻中度特发性肺纤维化的治疗，但这2种药物也仅能延缓肺纤维化的进展，并不能逆转纤维化的病理改变，且不能完全阻止患者肺功能的下降。
因此，亟需研发一种具有排毒平喘、化瘀通络功效的中药，辅助治疗， 以提高重症治愈率。
发明的公开
本发明的目的解决肺部纤维化的问题，提供一种用于清肺化纤的中药组合物，具有排毒平喘、化瘀通络功效，解决肺部纤维化的问题，尤其适用于新型冠状肺炎重症患者的治疗。
为了达到上述目的，本发明提供了一种用于清肺化纤的药物组合物，该组合物由按重量份计的下述组分组成：生麻黄6-10份、甘草3-10份、杏仁9-12份、生石膏15-20份、藿香6-12份、草果6-12份、法半夏8-12份、生大黄3-6份、太子参10-15份、葶苈子10-15份、赤芍10-15份、槟榔10-12份、枳实10-15份、僵蚕15-20份、浙贝母15-20份、丝瓜络15-20份、芦根8-12份。
较佳地，所述的生石膏需要预先煎制。
较佳地，所述的生石膏量1.5-2.5倍于生麻黄，以质量比计。
本发明还提供了一种根据上述的用于清肺化纤的药物组合物在制备用于清肺化纤的药物中的用途。
较佳地，该药物用于抗新型冠状病毒。
较佳地，所述的药物为以上述的药物组合物为活性成分，加上药学中可接受的辅料或辅助性成分制备而成的制剂。
较佳地，所述的活性组分包含：所述的药物组合物的药粉，水提取物或有机溶剂提取物。
较佳地，所述的制剂为散剂、片剂、膏剂、颗粒剂、胶囊剂或者口服液。
本发明的药物组合物的组方遵循君臣佐使的原则：以生石膏、生麻黄、浙贝母、僵蚕为君药，以杏仁、草果、法半夏、太子参、赤芍、丝瓜络为臣药，以藿香、生大黄、葶苈子、槟榔、枳实、芦根为佐药，以甘草为使。
本发明的药物组合物的配伍如下：
麻黄与石膏相配，麻黄味辛、微苦，性温，入肺、膀胱经，发汗以解
表，宣肺以平喘，利水以消肿；石膏味辛、甘，性大寒，入肺、胃经，专泻肺胃火热。两者相伍，一辛温，一辛寒，辛寒大于辛温，石膏量1.5-2倍于麻黄，不失为辛凉之重剂，对于肺胃热邪郁闭、气血内壅之证，麻黄宣 肺利气解表，石膏清泻肺胃郁热，共使肺气利，热邪清，咳喘自平，主治热壅于肺、肺失宣发之发热、咳喘。
浙贝母性寒，味苦，归肺经，主治痰热咳嗽、肺痈等症。浙贝母与麻黄、石膏共达清热散结、化痰止咳等功效。葶苈子性寒，味辛、苦，归肺、大肠经，功效为泻肺平喘。杏仁宣利肺气为臣，与葶苈子合用，助麻黄以止咳平喘。根据《饮膳正要》，“草果治太阴独胜之寒”；草果性温，味辛，入脾、胃经，有逐寒、除瘴、截疟、化浊、祛痰的功效。法半夏辛、温，归脾、胃、肺经，长于燥湿化痰，用于痰多咳喘。藿香性微温，味辛，归睥、胃、肺经，长于芳香化湿，和中止呕，用于湿阻中焦证，呕吐，暑湿或湿温，用于胸脘痞满，呕恶。槟榔性温，味苦、辛，归胃、大肠经，功效行气消积，截疟，用于食积痰滞。枳实性微寒，味苦、辛，入脾、胃、大肠经，功效为破气化痰，散积消痞，用于食积痰滞，胸腹痞满胀痛，常与槟榔同用，效果类似。草果与法半夏、藿香、槟榔、枳实合用，有健脾、除湿，化浊、祛痰滞功效。僵蚕咸、辛，平，归肝、肺、胃经。丝瓜络味甘，性寒，归肺经，长于祛风化痰，通络除痹。太子参味甘、微苦，性微寒，归脾、肺经，补气养血、健脾。赤芍性微寒，味苦，归肝经，长于散瘀活血。僵蚕与浙贝母、丝瓜络、太子参、赤芍合用，有化痰散结、益气活血、化瘀通络，促进肺部感染、渗出的病灶吸收及消失，实变范围缩小，密度减低，防止肺纤维化的发生的作用。芦根性寒，味甘，入肺、胃经，功效为清热除烦，用于咳嗽咽痛。生大黄味苦，归脾、胃、大肠等经，长于泻热毒，破积滞，行瘀血，根据“肺与大肠相表里理论”用于通腑气而降肺气止咳喘。甘草甘，平，归脾、胃、肺经，长于清热解毒，止咳、和中缓急，调和诸药为使。
诸药合用，具有清肺排毒、健脾平喘、化痰散结、化瘀通络、促进肺部感染、渗出的吸收，改善肺功能的功效。其中，防止肺纤维化的发生的作用的药物是生石膏、生麻黄、浙贝母、僵蚕。
本发明首次将具有清肺排毒、健脾平喘、化痰散结、化瘀通络功效的特定配伍中草药用于新型冠状肺炎重型患者，特别是具有化痰散结、化瘀通络功效的浙贝母、僵蚕、赤芍、丝瓜络配合用于防止肺纤维化的发生具有意料不到的技术效果。本发明提供的药物组合物，主要起到止咳喘，促进肺部感染、渗出的病灶吸收及消失，实变范围缩小，密度减低，防止肺纤维化，特 别适用于新冠病毒重症患者。
实现本发明的最佳方式
本发明提供的用于清肺化纤的药物组合物由按重量份计的下述组分组成：生麻黄6-10份、甘草3-10份、杏仁9-12份、生石膏15-20份、藿香6-12份、草果6-12份、法半夏8-12份、生大黄3-6份、太子参10-15份、葶苈子10-15份、赤芍10-15份、槟榔10-12份、枳实10-15份、僵蚕15-20份、浙贝母15-20份、丝瓜络15-20份、芦根8-12份。
实践中，该药物组合物依据配伍原则，视不同的症状表现或症状程度，在上述配方的范围内适当增减。
以下实施例中，生石膏均预先煎制处理。该预先煎制，是采用中药常规煎制方法，如，加水，煎制20分钟。
实施例1
分别称取生麻黄6g、甘草3g、杏仁9g、生石膏15g、藿香6g、草果6g、法半夏8g、生大黄3g、太子参10g、葶苈子10g、赤芍10g、槟榔10g、枳实10g、僵蚕15g、浙贝母15g、丝瓜络15g、芦根8g，加入2L左右的水煎煮，熬制成200ml，待用。
实施例2
分别称取生麻黄10g、甘草10g、杏仁12g、生石膏20g、藿香12g、草果12g、法半夏12g、生大黄6g、太子参15g、葶苈子15g、赤芍15g、槟榔12g、枳实15g、僵蚕20g、浙贝母20g、丝瓜络20g、芦根12g，加入2L左右的水煎煮，熬制成200ml，待用。
实施例3
分别称取生麻黄12g、甘草6g、杏仁10g、生石膏18g、藿香9g、草果9g、法半夏10g、生大黄4g、太子参12g、葶苈子13g、赤芍12g、槟榔11g、枳实12g、僵蚕18g、浙贝母18g、丝瓜络17g、芦根10g，加入2L左右的水煎煮，熬制成200ml，待用。
所有入组86例患者均给予上述的用于清肺化纤的药物组合物的汤剂(记为中药清肺化纤汤)口服，疗程为7天。
服法：水煎服，每日2次，每次1包(200ml)，口服或鼻饲。
证候疗效评定标准(中医证候评分表如表1所示)：
①临床痊愈：主要症状、体征消失，疗效指数≥95％。
②显效：主要症状、体征明显改善，70％≤疗效指数<95％。
③有效：主要症状、体征明显好转，30％≤疗效指数<70％。
④无效：主要症状、体征无明显改善，甚或加重，疗效指数<30％。
疗效指数＝[(治疗前积分－治疗后积分)/治疗前积分]×100％。
表1：中医证候评分表
Figure PCTCN2021079261-appb-000001
结果如下：
1.疗效评价
截止2020年4月7日，出院患者86例，无一例转为危重症，无死亡。如表2所示，总有效率94.18％，所有患者随访4周内无复发。
表2：清肺化纤汤治疗有效率％
总例数 痊愈 显效 有效 无效 总有效率
86 18(20.93％) 36(41.86％) 27(31.39％) 5(5.81％) 81(94.18％)
2.中医症状改善情况
治疗7天后，患者发热、乏力、咳嗽、纳差、气短及四肢酸痛证候的积分均低于治疗前(P<0.05)，如表3所示。其中乏力、纳差及气短较前改善最为明显。
表3：治疗前后中医证候积分比较
Figure PCTCN2021079261-appb-000002
表3中，符号“*”代表较治疗前比较P＜0.05。
3.新型冠状病毒核酸转阴时间及肺部CT改善情况
新型冠状病毒核酸转阴时间为6-13天，平均8.5天。CT显示治疗前肺部病灶以肺磨玻璃影(ground glass opacity，缩写为GGO)、GGO合并实变为主，多为两肺多个肺叶同时受累。服药后2周内复查肺部CT，结果显示79例(91.86％)患者肺部病灶较前吸收，其中完全吸收7例，部分吸收72例。主要表现在病灶数量减少，实变范围缩小，密度减低。肺损伤评分较治疗前下降，差异有统计学意义。
临床实践证明，本发明所述的药物组合物对重型患者的治疗有着逆转重症病情进展，降低病死率，提高治愈率的临床疗效。
本发明提供的用于清肺化纤的药物组合物适用于清肺化纤治疗，特别适用于感染新型冠状病毒的重症患者的治疗。
一些实施例中，以上述的药物组合物为活性成分，加上药学中可接受的辅料或辅助性成分制备而成制剂，该制剂可为散剂、片剂、膏剂、颗粒剂、胶囊剂或者口服液。
一些实施例中，所述的活性组分包含：所述的药物组合物的药粉，水提取物或有机溶剂提取物，该有机溶剂通常指乙醇。
综上所述，本发明提供的用于清肺化纤的药物组合物，将具有清肺排毒、健脾平喘、化痰散结、化瘀通络功效的特定配伍中草药用于改善新型冠状肺炎重型患者的肺纤维化症状，特别地，具有化痰散结、化瘀通络功效的浙贝母、僵蚕、赤芍、丝瓜络配合使用，用于防止肺纤维化的发生，起到了意料不到的技术效果，具有较佳的应用前景。
尽管本发明的内容已经通过上述优选实施例作了详细介绍，但应当认识到上述的描述不应被认为是对本发明的限制。在本领域技术人员阅读了上述内容后，对于本发明的多种修改和替代都将是显而易见的。因此，本发明的保护范围应由所附的权利要求来限定。

Claims (8)

  1. 一种用于清肺化纤的药物组合物，其特征在于，该组合物由按重量份计的下述组分组成：生麻黄6-10份、甘草3-10份、杏仁9-12份、生石膏15-20份、藿香6-12份、草果6-12份、法半夏8-12份、生大黄3-6份、太子参10-15份、葶苈子10-15份、赤芍10-15份、槟榔10-12份、枳实10-15份、僵蚕15-20份、浙贝母15-20份、丝瓜络15-20份、芦根8-12份。
  2. 如权利要求1所述的用于清肺化纤的药物组合物，其特征在于，所述的生石膏需要预先煎制。
  3. 如权利要求1所述的用于清肺化纤的药物组合物，其特征在于，所述的生石膏量1.5-2.5倍于生麻黄，以质量比计。
  4. 一种根据权利要求1所述的用于清肺化纤的药物组合物在制备用于清肺化纤的药物中的用途。
  5. 如权利要求4所述的用途，其特征在于，该药物用于抗新型冠状病毒。
  6. 如权利要求4所述的用途，其特征在于，所述的药物为以权利要求1所述的药物组合物为活性成分，配合药学中可接受的辅料或辅助性成分制备而成的制剂。
  7. 如权利要求6所述的用途，其特征在于，所述的活性组分包含：所述的药物组合物的药粉，水提取物或有机溶剂提取物。
  8. 如权利要求6所述的用途，其特征在于，所述的制剂为散剂、片剂、膏剂、颗粒剂、胶囊剂或者口服液。
PCT/CN2021/079261 2020-05-15 2021-03-05 一种用于清肺化纤的药物组合物及其用途 WO2021227614A1 (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202010416593.5 2020-05-15
CN202010416593.5A CN111588816A (zh) 2020-05-15 2020-05-15 一种用于清肺化纤的药物组合物及其用途

Publications (1)

Publication Number Publication Date
WO2021227614A1 true WO2021227614A1 (zh) 2021-11-18

Family

ID=72187347

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2021/079261 WO2021227614A1 (zh) 2020-05-15 2021-03-05 一种用于清肺化纤的药物组合物及其用途

Country Status (2)

Country Link
CN (1) CN111588816A (zh)
WO (1) WO2021227614A1 (zh)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116211982A (zh) * 2023-01-17 2023-06-06 上海市普陀区中心医院 一种治疗中低危肺部结节的复方制剂、制备方法及用途
CN116407597A (zh) * 2023-03-27 2023-07-11 首都医科大学附属北京中医医院 一种抗冠状病毒的宣白生脉汤及其制备方法

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111588816A (zh) * 2020-05-15 2020-08-28 武汉大学中南医院 一种用于清肺化纤的药物组合物及其用途
CN113975374B (zh) * 2021-10-20 2023-09-12 成都普睿法药物研发有限公司 太子参环肽b在制备抗实验性肺纤维化药物中的应用
CN115919963A (zh) * 2022-10-19 2023-04-07 湖南安邦制药股份有限公司 一种中药组合物在制备治疗新型冠状病毒感染药物中的应用

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104208473A (zh) * 2014-09-03 2014-12-17 上海市青浦区中医医院 一种治疗风热型咳喘疾病的中药组合物及其用途
CN111588816A (zh) * 2020-05-15 2020-08-28 武汉大学中南医院 一种用于清肺化纤的药物组合物及其用途

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101480437B (zh) * 2008-01-11 2012-05-30 曾雄辉 一种麻杏石甘汤制剂的制备方法
CN110075210A (zh) * 2019-05-20 2019-08-02 重庆三峡职业学院 一种治疗肉牛急性肺炎的药物及其制备方法

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104208473A (zh) * 2014-09-03 2014-12-17 上海市青浦区中医医院 一种治疗风热型咳喘疾病的中药组合物及其用途
CN111588816A (zh) * 2020-05-15 2020-08-28 武汉大学中南医院 一种用于清肺化纤的药物组合物及其用途

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
LIANG SUN, MING JIN CHEN, SONG YAN, XUE XING, XUE BO SHOU: "Thought on COVID 19 in Traditional Chinese Medicine by TCM Master", WORLD JOURNAL OF INTEGRATED TRADITIONAL AND WESTERN MEDICINE, vol. 15, no. 15, 31 March 2020 (2020-03-31), XP055866919 *

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116211982A (zh) * 2023-01-17 2023-06-06 上海市普陀区中心医院 一种治疗中低危肺部结节的复方制剂、制备方法及用途
CN116211982B (zh) * 2023-01-17 2023-12-12 上海市普陀区中心医院 一种治疗中低危肺部结节的复方制剂、制备方法及用途
CN116407597A (zh) * 2023-03-27 2023-07-11 首都医科大学附属北京中医医院 一种抗冠状病毒的宣白生脉汤及其制备方法
CN116407597B (zh) * 2023-03-27 2024-02-06 首都医科大学附属北京中医医院 一种抗冠状病毒的宣白生脉汤及其制备方法

Also Published As

Publication number Publication date
CN111588816A (zh) 2020-08-28

Similar Documents

Publication Publication Date Title
WO2021227614A1 (zh) 一种用于清肺化纤的药物组合物及其用途
WO2011063553A1 (zh) 一种治疗由甲型h1n1等流感病毒引起的流感的中药
WO2021208336A1 (zh) 中药组合物及其应用
CN103099948A (zh) 一种治疗咽炎的药物组合物和制备方法
WO2021179505A1 (zh) 一种翘芪复方制剂及其制备方法和用途
WO2023125798A1 (zh) 一种中药组合物及其制备方法和应用
WO2006094460A1 (fr) Medicament destine au traitement de la toux et de l&#39;asthme et son procede de preparation
CN111643562A (zh) 一种用于新冠肺炎预防的中药组合物及其制备方法和应用
CN102688384A (zh) 一种治疗慢性咽炎的中药汤剂
CN102349981B (zh) 一种治疗肺痈的中药
CN113855762A (zh) 一种中药组合物及其制备方法和应用
CN105031595A (zh) 一种治疗钱币状湿疹的中药片剂及其制备方法
CN111388612A (zh) 一种用于祛风润肺止咳的药物组合物及其制备方法
CN112316034A (zh) 一种用于治疗慢性咽炎的外敷中药组合物及制备方法和应用
CN101732469B (zh) 一种中药组合物在制备治疗失音症药物中的应用
CN110917271A (zh) 一种用于儿童、青少年过敏性哮喘合并过敏性鼻炎防治的喷雾剂
CN104998158A (zh) 一种治疗肝硬化的药物组合物及其应用
CN114917287B (zh) 一种治疗过敏性哮喘的中药组合物，其制备方法和应用
CN115040613B (zh) 改善病毒性感冒发热症状的中药组合物、应用及制剂
Wang et al. Research Progress on Recognition and Treatment of RSV Infection in Traditional Chinese Medicine
CN108926672B (zh) 一种治疗系统性红斑狼疮的中药组合物
CN117180374A (zh) 一种治疗病毒性肺炎的中药组合物
CN104758346A (zh) 一种治疗偏头痛的药物及其制备方法、制剂
CN105213975A (zh) 一种治疗肝硬化的药物组合物及其应用
CN116531457A (zh) 一种治疗慢性咽炎病症的中药组合物及其应用

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: 21803812

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 21803812

Country of ref document: EP

Kind code of ref document: A1