CA3168659A1 - Traditional chinese medicine compound with lung-clearing and toxin-expelling functions, and application thereof - Google Patents

Traditional chinese medicine compound with lung-clearing and toxin-expelling functions, and application thereof

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Publication number
CA3168659A1
CA3168659A1 CA3168659A CA3168659A CA3168659A1 CA 3168659 A1 CA3168659 A1 CA 3168659A1 CA 3168659 A CA3168659 A CA 3168659A CA 3168659 A CA3168659 A CA 3168659A CA 3168659 A1 CA3168659 A1 CA 3168659A1
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Prior art keywords
parts
traditional chinese
chinese medicine
lung
clearing
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CA3168659A
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French (fr)
Inventor
Youwen GE
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INSTITUTE OF BASIC RESEARCH IN CLINICAL MEDICINE CHINA ACADEMY OF CHINESE MEDICAL SCIENCES
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INSTITUTE OF BASIC RESEARCH IN CLINICAL MEDICINE CHINA ACADEMY OF CHINESE MEDICAL SCIENCES
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Publication of CA3168659A1 publication Critical patent/CA3168659A1/en
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/17Gnetophyta, e.g. Ephedraceae (Mormon-tea family)
    • AHUMAN NECESSITIES
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
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    • A61K36/07Basidiomycota, e.g. Cryptococcus
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    • A61K36/076Poria
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    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/23Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/233Bupleurum
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    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/26Aristolochiaceae (Birthwort family), e.g. heartleaf
    • A61K36/268Asarum (wild ginger)
    • AHUMAN NECESSITIES
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/284Atractylodes
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    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
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    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/484Glycyrrhiza (licorice)
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    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
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    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/73Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A61K36/736Prunus, e.g. plum, cherry, peach, apricot or almond
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    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/75Rutaceae (Rue family)
    • A61K36/752Citrus, e.g. lime, orange or lemon
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/888Araceae (Arum family), e.g. caladium, calla lily or skunk cabbage
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Abstract

A traditional Chinese medicine compound with the functions of clearing lungs and detoxification, prepared from the following traditional Chinese medicinal materials in parts by weight: 8-10 parts of Ephedra, 5-8 parts of roasted licorice, 8-10 parts of almonds, 15-30 parts of raw gypsum, 8-10 parts of cinnamon sticks, 8-10 parts of Alisma, 8-10 parts of Polyporus, 8-10 parts of Atractylodes, 15 parts of Poria cocos, 15-18 parts of Bupleurum, 5-8 parts of Scutellaria baicalensis, 8-10 parts of ginger processed Pinellia, 8-10 parts of fresh ginger, 8-10 parts of Aster, 8-10 parts of coltsfoot flowers, 8-10 parts of blackberry lily, 5-8 parts of Asarum, 10-14 parts of Chinese yam, 5-8 parts of Citrus aurantium, 5-8 parts of tangerine peel, and 8-10 parts of Agastache. The traditional Chinese medicine compound has a significant therapeutic effect on pneumonia symptoms caused by novel coronavirus infection.

Description

TRADITIONAL CHINESE MEDICINE COMPOUND WITH
LUNG-CLEARING AND TOXIN-EXPELLING FUNCTIONS, AND
APPLICATION THEREOF
TECHNICAL FIELD
[0001] The present invention relates to a traditional Chinese medicine composition, and more particularly, to a traditional Chinese medicine compound with lung-clearing and toxin-expelling functions.
BACKGROUND
[0002] Viral pneumonia is an inflammation of an upper respiratory tract, which spreads down to a lower respiratory tract to a bronchus and a lung after a viral infection, with influenza virus infection being the most common.
[0003] However, 2019 novel coronavirus, officially named 2019-nCoV by the World Health Organization on January 12th, 2020, is a novel coronavirus strain found in human bodies. Symptoms of this virus are generally viral pneumonia symptoms such as fever, malaise, dry cough and progressive dyspnea. The severe cases are acute respiratory distress syndrome, septic shock, and refractory metabolic acidosis and coagulation disorder. It has been confirmed that the virus is characterized by human-to-human transmission, and is infectious during an incubation period, and there is no specific treatment for diseases caused by the virus.
[0004] As of the filing date of the present application, mutant 2019-nCoV has been found in multiple countries, but the effectiveness of the currently developed 2019-nCoV vaccines against the mutant 2019-nCoV has not been confirmed.
Therefore, there is a great need for research and development of medicines that can effectively treat COVID-19.
SUMMARY
[0005] In order to solve the problems in the prior art, the object of the present invention is to provide a traditional Chinese medicine compound with the lung-clearing and toxin-expelling functions and an application thereof, so as to treat viral pneumonia, especially to provide an effective treatment solution for viral Date Recue/Date Received 2022-07-20 pneumonia caused by 2019-nCoV and mutant viruses thereof.
[0006] To implement the foregoing object, a technical solution of the present invention is as follows:
[0007] In a first aspect, the present invention provides a traditional Chinese medicine compound with lung-clearing and toxin-expelling functions, wherein raw materials of the traditional Chinese medicine compound comprise the following traditional Chinese medicinal materials in parts by weight:
[0008] 8-10 parts of ephedra, 5-8 parts of radix glycyrrhizae preparata, 8-10 parts of almond, 15-30 parts of gypsum, 8-10 parts of cassia twig, 8-10 parts of rhizoma alismatis, 8-10 parts of polyporus umbellatus, 8-10 parts of atractylodes macrocephala, 15 parts of poria, 15-18 parts of bupleurum chinense, 5-8 parts of scutellaria baicalensis, 8-10 parts of pinellia rhizoma prepared by ginger, 8-10 parts of ginger, 8-10 parts of aster, 8-10 parts of tussilago farfara, 8-10 parts of belamcanda chinensis, 5-8 parts of asarum, 10-14 parts of yam, 5-8 parts of immature bitter orange, 5-8 parts of orange peel, and 8-10 parts of wrinkled gianthyssop.
[0009] A formula of the traditional Chinese medicine compound according to the present invention, with reference to the classic work of Chinese medicine "Treatise on Febrile and Miscellaneous Diseases" by Zhang Zhongjing of the Han Dynasty, consists of a decoction of ephedra, almond, licorice and gypsum (referred to as ephedra-almond-licorice-gypsum decoction, Treatise on Typhoid 63), a minor radix bupleuri decoction (Treatise on Typhoid 96), hoelen five powder (Treatise on Typhoid 71), and a betamcanda and ephedra decoction (Synopsis of Golden Chamber.
Treatment of Lung Atrophy and Lung Carbuncle with Cough and Abnormal Rising of Qi 7) with the addition and subtraction of the medicine materials. The yam, the immature bitter orange, the orange peel and the wrinkled gianthyssop are added and subtracted according to clinical symptoms of the pneumonia caused by the novel coronavirus infection this time.

Date Recue/Date Received 2022-07-20 10010] The ephedra-almond-licorice-gypsum decoction diffuses the lung and removes pathogenic qi; the hoelen five powder dispels moisture and turbidity, clears the triple energizer, and makes moisture gather in urine, so that the moisture is removed from pores and urine; the minor radix bupleuri decoction cards Shaoyang pivot; the betamcanda and ephedra decoction is an exterior-relieving and fluid-dispersing decoction capable of descending qi and relieving a cough; the wrinkled gianthyssop, the immature bitter orange and the orange peel regulate the qi functions of spleen and stomach, and the fragrance thereof can promote qi and eliminate turbidity, so that turbidity qi in chest and abdomen can be eliminated and breathing can be smooth; moreover, the yam invigorates spleen and kidney, and strengthens vital qi. The whole formula has the effects of dispelling moisture and turbidity, clearing lung heat and removing pathogenic qi, and regulating qi functions.
[0011] Preferably, raw materials of the traditional Chinese medicine compound comprise the following traditional Chinese medicinal materials in parts by weight: 9 parts of ephedra, 6 parts of radix glycyrrhizae preparata, 9 parts of almond, parts of gypsum, 9 parts of cassia twig, 9 parts of rhizoma alismatis, 9 parts of polyporus umbellatus, 9 parts of atractylodes macrocephala, 15 parts of poria, 16 parts of bupleurum chinense, 6 parts of scutellaria baicalensis, 9 parts of pinellia rhizoma prepared by ginger, 9 parts of ginger, 9 parts of aster, 9 parts of tussilago farfara, 9 parts of belamcanda chinensis, 6 parts of asarum, 12 parts of yam, 6 parts of immature bitter orange, 6 parts of orange peel, and 9 parts of wrinkled gianthyssop.
[0012] A dosage of the gypsum may be adjusted according to whether a patient has a fever. If the patient does not have a fever, the dosage of the gypsum is small, and if the patient has a fever or strong fever, the dosage of the gypsum is increased.
[0013] Further, the traditional Chinese medicine compound is optionally in a dosage form of water decoction (decoction of herbal medicine), granule, ointment, pill, powder, elixir or tablet, but not limited to these dosage forms.

Date Recue/Date Received 2022-07-20 [0014] The specific preparation methods of the above dosage forms may be carried out by using the conventional preparation methods in the field, and the water decoction and the granule are preferably used to exert a therapeutic effect of the medicine.
[0015] Therefore, in a second aspect, the present invention further illustrates preparation methods of a decoction of herbal medicine with lung-clearing and a granule with lung-clearing and toxin-expelling functions by taking the water decoction (decoction of herbal medicine) and the granule as examples from the optional dosage forms of the above-mentioned traditional Chinese medicine compound.
[0016] Specifically, a decoction of herbal medicine with lung-clearing and toxin-expelling functions (water decoction), wherein the decoction of herbal medicine with lung-clearing and toxin-expelling functions is prepared by weighing various traditional Chinese medicinal materials based on the traditional Chinese medicine compound according to the present invention, decocting the gypsum in water, and then adding the rest traditional Chinese medicinal materials into the mixture to obtain a decoction solution.
[0017] Specifically, a granule with lung-clearing and toxin-expelling functions, wherein a preparation method of the granule comprises the following steps of:
[0018] (1) decocting: weighing various traditional Chinese medicinal materials based on the traditional Chinese medicine compound above, decocting the gypsum in water, and then adding the rest twenty traditional Chinese medicinal materials into the mixture and decocting the same with water to obtain a decoction solution;
[0019] (2) concentrating: filtering the obtained decoction solution, and concentrating to obtain a concentrated water extract; and [0020] (3) granulating and molding: taking the concentrated water extract as a raw material, adding stevioside and an appropriate amount of dextrin, and granulating in Date Recue/Date Received 2022-07-20 one step to obtain the granule with lung-clearing and toxin-expelling functions.
[0021] Preferably, the traditional Chinese medicinal materials used in the preparation of the above specific medicament are traditional Chinese medicine decoction pieces.
[0022] In a third aspect, the present invention provides an application of the traditional Chinese medicine compound in preparing a medicine with lung-clearing and toxin-expelling functions, and particularly an application in preparing a medicine for treating a pneumonia infected by novel coronavirus.
[0023] The present invention further provides an application of the traditional Chinese medicine compound as a medicine for treating a pneumonia caused by virus infection.
[0024] In other words, the present invention provides an application of the traditional Chinese medicine compound in preparing a medicine for treating a pneumonia caused by virus infection.
[0025] Further, the present invention provides an application of the traditional Chinese medicine compound (and the forgoing decoction of herbal medicine with lung-clearing and toxin-expelling functions or the forgoing granule with lung-clearing and toxin-expelling functions) in treating viral pneumonia, and particularly an application in treating a pneumonia caused by novel coronavirus 2019-nCoV
infection.
[0026] Objective experiment proves that the traditional Chinese medicine compound of the present invention has a good therapeutic effect on the pneumonia caused by novel coronavirus 2019-nCoV infection.
[0027] As a recommendation, an application method of the traditional Chinese medicine compound is: decocting with water, and taking one warm dose by twice in the morning and evening (40 minutes after a meal). If conditions permit, a half bowl of rice soup is taken after taking one dose of medicines, and those with dry tongue Date Recue/Date Received 2022-07-20 and deficiency of fluid may take one bowl of rice soup. Three doses make up one course of treatment. It is suggested that the patient should take a full course of treatment according to the original formula, and take a second course of treatment if the symptom is improved but not cured. If the patient has special conditions or other basic diseases, the formula of the second course of treatment may be modified according to the actual situations, and the medicine is withdrawn when the symptom disappears [0028] In addition, if the patient suffering constipation before taking this formula, the patient needs to take a miraculous pill of ledebouriella and stop taking the pill after defecation.
[0029] The raw materials of the traditional Chinese medicinal materials involved in the present invention are all common commercially available products, and the involved operations are routine operations in the field unless otherwise specified.
[0030] On the basis of meeting the common knowledge in the field, the above preferred conditions may be combined with each other to obtain the specific embodiments.
[0031] The present invention has the beneficial effects that:
[0032] According to the present invention, combined with the epidemic symptoms of the " COVID-19" this time, it is considered that the pneumonia infected by the novel coronavirus (2019-nCoV) belongs to the category of "cold pestilence" of traditional Chinese medicine, and damp evil is the most prevalent pathogen.
The main location of the disease is lung, followed by exterior health, spleen and stomach. The disease is mainly caused by dryness mingled with cold-dampness and pathogenic qi.
The main pathogenesis is the aggregation of epidemic cold-dampness and dryness, which leads to qi function stagnation and abnormal rising and descending.
[0033] According to this, the present invention provides the forgoing traditional Chinese medicine compound, which utilizes a plurality of traditional Chinese Date Recue/Date Received 2022-07-20 medicines to be optimally integrated to treat together. At present, from the treatment of confirmed patients of different ages in many provinces and places, the curative effect is exact. Related clinical observational studies are ongoing.
[0034] The traditional Chinese medicine compound (decoction of herbal medicine with lung-clearing and toxin-expelling functions) provided by the present invention is a traditional Chinese medicine compound used in "Clinical Screening Study of Effective Traditional Chinese Medicine Compound for Prevention and Treatment of Pneumonia Infected by Novel Coronavirus" of the emergency scientific research project of State Administration of Traditional Chinese Medicine. At present, clinical observation work is being carried out in combination with clinical salvage, and related research is continuing to advance. This formula is applied to light, ordinary and severe patients, may also be reasonably used in the treatment of critical patients in combination with the actual situation of patients, and has good social benefits.
DETAILED DESCRIPTION OF THE EMBODIMENTS
[0035] The preferred embodiments of the present invention will be further described hereinafter in detail with reference to the embodiments. It should be understood that the following embodiments are given only for the purpose of illustration, and are not intended to limit the scope of the present invention. Those skilled in the art can make various modifications and substitutions to the present invention without departing from the purpose and spirit of the present invention.
[0036] The experimental methods used in the following embodiments are conventional unless otherwise specified.
[0037] The materials, reagents, and the like, used in the following embodiments are commercially available unless otherwise specified.
[0038] Embodiment I
[0039] This embodiment was used to illustrate a decoction of herbal medicine with lung-clearing and toxin-expelling functions (water decoction) and a preparation Date Recue/Date Received 2022-07-20 method thereof.
[0040] I. Raw materials (in parts by weight):
[0041] 9 parts of ephedra, 6 parts of radix glycyrrhizae preparata, 9 parts of almond, 15-30 parts of gypsum, 9 parts of cassia twig, 9 parts of rhizoma alismatis, 9 parts of polyporus umbellatus, 9 parts of atractylodes macrocephala, 15 parts of poria, 16 parts of bupleurum chinense, 6 parts of scutellaria baicalensis, 9 parts of pinellia rhizoma prepared by ginger, 9 parts of ginger, 9 parts of aster, 9 parts of tussilago farfara, 9 parts of belamcanda chinensis, 6 parts of asarum, 12 parts of yam, 6 parts of immature bitter orange, 6 parts of orange peel, and 9 parts of wrinkled gianthyssop.
[0042] A dosage of the gypsum was adjusted within the above dosage scope according to that whether a patient had a fever. If the patient did not have a fever, the dosage of the gypsum was small, and if the patient had a fever or strong fever, the dosage of the gypsum was increased.
[0043] II. Preparation method [0044] The traditional Chinese medicinal materials (traditional Chinese Medicine decoction pieces) were weighed based on the weight ratio above, the gypsum was decocted in water first, and then the rest twenty traditional Chinese medicinal materials (traditional Chinese Medicine decoction pieces) were added and combined into the mixture and decocted.
[0045] After the decoction was finished, the decoction of herbal medicine with lung-clearing and toxin-expelling functions was obtained.
[0046] Embodiment 2 [0047] This embodiment was different from Embodiment 1 in that:
[0048] Raw materials (in parts by weight):
[0049] 8 parts of ephedra, 7 parts of radix glycyrrhizae preparata, 10 parts of almond, 15-30 parts of gypsum, 8 parts of cassia twig, 10 parts of rhizoma alismatis,
10 parts of polyporus umbellatus, 8 parts of atractylodes macrocephala, 14 parts of poria, 15 Date Recue/Date Received 2022-07-20 parts of bupleurum chinense, 7 parts of scutellaria baicalensis, 10 parts of pinellia rhizoma prepared by ginger, 8 parts of ginger, 10 parts of aster, 8 parts of tussilago farfara, 10 parts of belamcanda chinensis, 5 parts of asarum, 13 parts of yam, 5 parts of immature bitter orange, 7 parts of orange peel, and 10 parts of wrinkled gianthyssop.
[0050] Embodiment 3 [0051] This embodiment was different from Embodiment 1 in that:
[0052] Raw materials (in parts by weight):
[0053] 10 parts of ephedra, 6 parts of radix glycyrrhizae preparata, 8 parts of almond, 15-30 parts of gypsum, 10 parts of cassia twig, 8 parts of rhizoma alismatis, 8 parts of polyporus umbellatus,10 parts of atractylodes macrocephala, 15 parts of poria, parts of bupleurum chinense, 6 parts of scutellaria baicalensis,9 parts of pinellia rhizoma prepared by ginger, 9 parts of ginger, 8 parts of aster,9 parts of tussilago farfara, 10 parts of belamcanda chinensis,6 parts of asarum, 12 parts of yam, 6 parts of immature bitter orange, 5 parts of orange peel, and 8 parts of wrinkled gianthyssop.
[0054] Embodiment 4 [0055] This embodiment was different from Embodiment 1 in that:
[0056] Raw materials (in parts by weight):
[0057] 9 parts of ephedra, 6 parts of radix glycyrrhizae preparata, 10 parts of almond, 15-30 parts of gypsum, 9 parts of cassia twig, 9 parts of rhizoma alismatis, 10 parts of polyporus umbellatus, 10 parts of atractylodes macrocephala, 15 parts of poria, 16 parts of bupleurum chinense, 6 parts of scutellaria baicalensis, 9 parts of pinellia rhizoma prepared by ginger, 8 parts of ginger, 9 parts of aster, 10 parts of tussilago farfara, 9 parts of belamcanda chinensis, 6 parts of asarum, 12 parts of yam, 5 parts of immature bitter orange, 6 parts of orange peel, and 9 parts of wrinkled gianthyssop.
[0058] Embodiment 5 [0059] This embodiment was used to illustrate a granule with lung-clearing and Date Recue/Date Received 2022-07-20 toxin-expelling functions and a preparation method thereof.
[0060] I. Raw materials (in parts by weight):
[0061] 9 parts of ephedra, 6 parts of radix glycyrrhizae preparata, 9 parts of almond, 15-30 parts of gypsum, 9 parts of cassia twig, 9 parts of rhizoma alismatis, 9 parts of polyporus umbellatus, 9 parts of atractylodes macrocephala, 15 parts of poria, 16 parts of bupleurum chinense, 6 parts of scutellaria baicalensis, 9 parts of pinellia rhizoma prepared by ginger, 9 parts of ginger, 9 parts of aster, 9 parts of tussilago farfara, 9 parts of belamcanda chinensis, 6 parts of asarum, 12 parts of yam, 6 parts of immature bitter orange, 6 parts of orange peel, and 9 parts of wrinkled gianthyssop.
[0062] II. Preparation method [0063] (1) decocting: weighing various traditional Chinese medicinal materials based on the traditional Chinese medicine compound above, decocting the gypsum in water, and then adding the rest twenty traditional Chinese medicinal materials into the mixture and decocting the same with water to obtain a decoction solution;
[0064] (2) concentrating: filtering the obtained decoction solution, and concentrating to obtain a concentrated water extract; and [0065] (3) granulating and molding: taking the concentrated water extract as a raw material, adding stevioside and an appropriate amount of dextrin, and granulating in one step to obtain the granule with lung-clearing and toxin-expelling functions.
[0066] Compared with the above-mentioned decoction, the granule with lung-clearing and toxin-expelling functions prepared in this embodiment has a better industrial production prospect, is beneficial to storage and transportation, and is easy to realize wider popularization and application.
[0067] Experimental Example 1 Therapeutic effect of the traditional Chinese medicine compound of the present invention on COVID-19 [0068] Confirmed cases of pneumonia infected by novel coronavirus were treated with the decoction of herbal medicine with lung-clearing and toxin-expelling Date Recue/Date Received 2022-07-20 functions.
[0069] According to the decoction of herbal medicine with lung-clearing and toxin-expelling functions prepared by the preparation method described in Embodiment 1, in one dose of medicine, each traditional Chinese medicinal material was weighed with 1 g in weight.
[0070] The medicine was decocted with water, and taken one warm dose by twice in the morning and evening (40 minutes after a meal). Three doses made up one course of treatment. If conditions permitted, a half bowl of rice soup was taken after taking one dose of medicine, and those with dry tongue and deficiency of fluid might take one bowl of rice soup.
[0071] As of December 1st, 2020, the decoction of herbal medicine with lung-clearing and toxin-expelling functions prepared by the traditional Chinese medicine compound according to the present invention had been used in 60 hospitals in 54 cities of 12 provinces in China, with a total of 1,137 confirmed cases of pneumonia infected by novel coronavirus. Through comprehensive observation of symptoms such as malaise, fever, cough, pharyngalgia, anorexia and imaging, the data showed that:
[0072] After 137 patients took the medicine, a total effective rate was about 96.66%.
Symptoms of 1,099 patients were improved or disappeared after taking the medicine, with nucleic acid testing turned negative and recovered, accounting for about 96.66%
of the total observed cases. Symptoms of the other 38 patients were not improved, accounting for about 3.34% of the total observed cases.
[0073] Experimental Example 2 Therapeutic effect of the traditional Chinese medicine compound of the present invention on pneumonia caused by non-novel coronavirus [0074] Other viral pneumonia cases that were infected by non-novel coronavirus (novel coronavirus test negative) were treated with the decoction of herbal medicine
11 Date Recue/Date Received 2022-07-20 with lung-clearing and toxin-expelling functions.
[0075] According to the decoction of herbal medicine with lung-clearing and toxin-expelling functions prepared by the preparation method described in Embodiment 1, in one dose of medicine, each traditional Chinese medicinal material was weighed with 1 g in weight.
[0076] The medicine was decocted with water, and taken one warm dose by twice in the morning and evening (40 minutes after a meal). Three doses made up one course of treatment. If conditions permitted, a half bowl of rice soup was taken after taking one dose of medicine, and those with dry tongue and deficiency of fluid might take one bowl of rice soup.
[0077] As of March 11th, 2020, the decoction of herbal medicine with lung-clearing and toxin-expelling functions prepared by the traditional Chinese medicine compound according to the present invention had been used in 62 hospitalized cases of viral pneumonia (non-COVID-19) from two hospitals in two cities of two provinces in China (Shaanxi Infectious Disease Hospital and Harbin Infectious Disease Hospital).
Through comprehensive observation of symptoms such as malaise, fever, cough, pharyngalgia, anorexia and imaging, the data showed that:
[0078] After taking, the decoction of herbal medicine was effective to 59 patients, and a total effective rate was about 95.16%. Symptoms of 59 patients were improved or disappeared after taking the medicine, accounting for about 95.16% of the total observed cases. Symptoms of the other 3 patients still had symptoms such as cough and malaise after taking the medicine, but were all recovered, accounting for about 4.84% of the total observed cases.
[0079] It is indicated that the traditional Chinese medicine compound of the present invention has excellent therapeutic effect on viral pneumonia.
[0080] Experimental Example 3 Medicine safety test [0081] In this experimental example, the granule with lung-clearing and
12 Date Recue/Date Received 2022-07-20 toxin-expelling functions prepared in Embodiment 5 was used to carry out a medicine safety test to prove the safety of the traditional Chinese medicine compound according to the present invention.
[0082] 1. Test purpose:
[0083] To evaluate the acute toxicity of the granule with lung-clearing and toxin-expelling functions given orally to mice. Death situations of animals after administration of the test substance were observed, and maximum tolerance was measured; and toxic symptoms and degrees within 14 days as well as the time when toxicity appeared and the time when the toxicity disappeared were continuously observed, so as to provide reference for other safety evaluation tests and clinical trials.
[0084] 2. Test method:
[0085] 140 ICR mice, weighing 18-21 g, were randomly divided into 7 groups according to fasting weight: a control group and six dosage groups of granules with lung-clearing and toxin-expelling functions (104.5 g, 122.9 g, 144.6 g, 170.1 g, 200.2 g and 235.5 g of crude medicine/kg), with 20 mice in each group, half male and half female. After fasting for about 15 hours, each medicine administration group was given a dosage of 40 mL/kg by stomach, and the control group was given an equal volume of purified water once a day. After administration, the animals were observed continuously for 14 days. After fasting for 15 days, surviving animals were dissected.
[0086] After the administration, it was observed immediately whether the animals had toxic reactions, toxic symptoms and toxic degrees, the time when the toxicity appeared and the time when the toxicity disappeared, adverse reactions were recorded, and the dead animals were subjected to gross autopsy, comprising the observation of animal fur, eyes, ears, mouth, nose, reproductive foramen, anus and its mucosa, and the observation of the main tissues and organs comprising heart, liver, spleen, lung, kidney, thymus, adrenal gland, trachea, esophagus, brain, testis, epididymis, uterus, ovary and the like. The weights and feed amounts of the mice were weighed on the 1st,
13 Date Recue/Date Received 2022-07-20 2nd, 3rd, 5th, /¨th, 10th and 14th day after the administration. At the end of the observation period on the 14th day, the mice were fasted, and the surviving animals were dissected as above.
[0087] 3. Test results:
[0088] The granule with lung-clearing and toxin-expelling functions was given to the animals by gavage at the dosage of 104.5 g, 122.9 g, 144.6 g, 170.1 g, 200.2 g and 235.5 g of crude medicine/kg once a day. The main toxic reactions observed were diarrhea, and activity abnormalities (comprising decrease or increase of spontaneous activity, repose, or the like), startle reflex, tremor and acute death.
[0089] Animal death occurred in the dosage group of 14.6 g of crude medicine/kg and above after the administration, but not in the dose group of 122.9 g of crude medicine/kg and below, all of which occurred within 24 hours after the administration, and the peak of death occurred within 120-370 minutes after the administration.
Mortality rates of the animals in the above six dosage groups were 0%, 0%, 5%, 15%, 10% and 15% respectively.
[0090] Except for acute death, other visible adverse reactions were diarrhea, activity abnormality and startle reflex. The dosage groups of 44.6 g, 170.1 g, 200.2 g, and 235.5 g of crude medicine/kg all had the above indications changed in varying degrees, with incidence rates of 65%, 75%, 90%, and 70% respectively, which occurred within 10-410 minutes the administration, and all recovered within 24 hours.
The dosage group of 122.9 g crude medicine/kg only showed soft stool/diarrhea, which occurred within 70-370min after the administration and recovered within 40-310min, with an incidence rate of 30%. The dosage group of 104.5 g crude medicine/kg had no visible adverse reactions. Thereafter, until the end of the observation period on the 14th day, the general conditions, activities, gait, breathing, eating, drinking, defecation and fur of the animals were not abnormal.
[0091] Compared with the control group, within 14 days after the administration, the
14 Date Recue/Date Received 2022-07-20 body weights of the male animals (the dosage groups of 170.1 g and 200.2 g of crude medicine/kg) and the female animals (the dosage groups of 144.6 g, 170.1 g, 200.2 g and 235.5 g of crude medicine/kg) administrated with the granule with lung-clearing and toxin-expelling functions decreased significantly on the Pt day after administration. Compared with the control group, the food intake of the male animals (the dosage groups of 170.1 g, 200.2 g and 235.5 g of crude medicine/kg) also decreased significantly on the Pt day after administration. From the 2nd day after the administration to the end of the observation period on the 14th day, there was no significant statistical difference in the body weight and the food intake between each dosage group and the control group at each time point.
[0092] After 14 days, all the surviving animals were dissected, and no obvious gross pathological changes were found.
[0093] 4. Test conclusion:
[0094] Different doses of the granule with lung-clearing and toxin-expelling functions were given to the mice with the dosage of 40 mL/kg, once orally. The visible adverse reactions were diarrhea, activity abnormalities (comprising spontaneous activity decrease or increase, repose, or the like), startle reflex, tremor and acute death. All the adverse reactions of the animals occurred within 24 hours after the administration, and all the surviving animals recovered the next day after the administration. The maximum tolerated dosage was 122.9 g of crude medicine/kg, which was 44 times of the maximum clinical dosage (196 g of crude medicine/person).
The maximum non-toxic reaction dosage was 104.5 g crude medicine/kg, which was 37 times of the maximum clinical dosage.
[0095] Although the present invention has been described above in detail with reference to general description and specific embodiments, some modifications or improvements can be made on the basis of the present invention, which is apparent to those skilled in the art. Therefore, these modifications or improvements made without Date Recue/Date Received 2022-07-20 departing from the spirit of the present invention shall fall within the protection scope of the present invention.
INDUSTRIAL APPLICABILITY
[0096] The traditional Chinese medicine compound with lung-clearing and toxin-expelling functions according to the present invention, with reference to the classic work of Chinese medicine "Treatise on Febrile and Miscellaneous Diseases"
by Zhang Zhongjing of the Han Dynasty, consists of a decoction of ephedra, almond, licorice and gypsum (referred to as ephedra-almond-licorice-gypsum decoction, Treatise on Typhoid 63), a minor radix bupleuri decoction (Treatise on Typhoid 96), hoelen five powder (Treatise on Typhoid 71), and a betamcanda and ephedra decoction (Synopsis of Golden Chamber. Treatment of Lung Atrophy and Lung Carbuncle with Cough and Abnormal Rising of Qi 7) with the addition and subtraction of the medicine materials, which has obvious therapeutic effect on the symptoms of novel coronavirus pneumonia COVID-19 by optimizing and fusing various traditional Chinese medicines to treat together.

Date Recue/Date Received 2022-07-20

Claims (10)

CA 03168659 2022-07-20
1. A traditional Chinese medicine compound with lung-clearing and toxin-expelling functions, wherein the traditional Chinese medicine compound is prepared from the following traditional Chinese medicinal materials in parts by weight:
8-10 parts of ephedra, 5-8 parts of radix glycyrrhizae preparata, 8-10 parts of almond, 15-30 parts of gypsum, 8-10 parts of cassia twig, 8-10 parts of rhizoma alismatis, 8-10 parts of polyporus umbellatus, 8-10 parts of atractylodes macrocephala, 15 parts of poria, 15-18 parts of bupleurum chinense, 5-8 parts of scutellaria baicalensis, 8-10 parts of pinellia rhizoma prepared by ginger, 8-10 parts of ginger, 8-10 parts of aster, 8-10 parts of tussilago farfara, 8-10 parts of belamcanda chinensis, 5-8 parts of asarum, 10-14 parts of yam, 5-8 parts of immature bitter orange, 5-8 parts of orange peel, and 8-10 parts of wrinkled gianthyssop.
2. The traditional Chinese medicine compound according to claim 1, wherein the parts by weight of the traditional Chinese medicinal materials are:
9 parts of ephedra, 6 parts of radix glycyrrhizae preparata, 9 parts of almond, 15-30 parts of gypsum, 9 parts of cassia twig, 9 parts of rhizoma alismatis, 9 parts of polyporus umbellatus, 9 parts of atractylodes macrocephala, 15 parts of poria, 16 parts of bupleurum chinense, 6 parts of scutellaria baicalensis, 9 parts of pinellia rhizoma prepared by ginger, 9 parts of ginger, 9 parts of aster, 9 parts of tussilago farfara, 9 parts of belamcanda chinensis, 6 parts of asarum, 12 parts of yam, 6 parts of immature bitter orange, 6 parts of orange peel, and 9 parts of wrinkled gianthyssop.
3. The traditional Chinese medicine compound according to claim 1 or 2, wherein the traditional Chinese medicine compound is in a dosage form of water decoction, granule, ointment, pill, powder, elixir or tablet.
4. A decoction of herbal medicine with lung-clearing and toxin-expelling functions, wherein the decoction of herbal medicine is prepared by weighing various traditional Chinese medicinal materials based on the traditional Chinese medicine compound according to claim 1 or 2, decocting the gypsum in water, and then adding Date Recue/Date Received 2022-07-20 the rest traditional Chinese medicinal materials into the mixture to obtain a decoction solution.
5. A granule with lung-clearing and toxin-expelling functions, wherein a preparation method of the granule comprises the following steps of:
(1) decocting: weighing various traditional Chinese medicinal materials based on the traditional Chinese medicine compound according to claim 1 or 2, decocting the gypsum in water, and then adding the rest twenty traditional Chinese medicinal materials into the mixture and decocting the same with water to obtain a decoction solution;
(2) concentrating: filtering the obtained decoction solution, and concentrating to obtain a concentrated water extract; and (3) granulating and molding: taking the concentrated water extract as a raw material, adding stevioside and an appropriate amount of dextrin, and granulating in one step to obtain the granule with lung-clearing and toxin-expelling functions.
6. An application of the traditional Chinese medicine compound according to any one of claims 1-3 in preparing a medicine with lung-clearing and toxin-expelling functions.
7. An application of the traditional Chinese medicine compound according to any one of claims 1-3 in preparing a medicine for treating a pneumonia infected by novel coronavirus.
8. An application of the traditional Chinese medicine compound according to any one of claims 1-3 as a medicine for treating a pneumonia caused by virus infection.
9. An application of the traditional Chinese medicine compound according to any one of claims 1-3 in preparing a medicine for treating a pneumonia caused by virus infection.
10. An application of the Chinese medicinal compound according to any one of claims 1-3, or the decoction of herbal medicine with lung-clearing and toxin-expelling functions according to claim 4, or the granule with lung-clearing and toxin-expelling Date Recue/Date Received 2022-07-20 functions according to claim 5 in treating viral pneumonia.

Date Recue/Date Received 2022-07-20
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CN107875278A (en) * 2017-12-08 2018-04-06 江苏师范大学 A kind of Chinese medicine sachet for deficiency of Yin matter crowd's flu-prevention
CN110870402B (en) * 2020-02-06 2020-07-17 葛又文 Traditional Chinese medicine compound for treating pneumonia caused by novel coronavirus infection and application thereof

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