WO2021103777A1 - Agent de pulvérisation pour la prévention et le traitement de l'asthme allergique combiné à une rhinite allergique chez les enfants et adolescents - Google Patents

Agent de pulvérisation pour la prévention et le traitement de l'asthme allergique combiné à une rhinite allergique chez les enfants et adolescents Download PDF

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WO2021103777A1
WO2021103777A1 PCT/CN2020/116449 CN2020116449W WO2021103777A1 WO 2021103777 A1 WO2021103777 A1 WO 2021103777A1 CN 2020116449 W CN2020116449 W CN 2020116449W WO 2021103777 A1 WO2021103777 A1 WO 2021103777A1
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parts
volatile oil
children
chinese medicine
allergic rhinitis
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PCT/CN2020/116449
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Chinese (zh)
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赵天抒
李华京
王静
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垒途智能教科技术研究院江苏有限公司
南京中垒科技发展有限公司
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Publication of WO2021103777A1 publication Critical patent/WO2021103777A1/fr

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    • AHUMAN NECESSITIES
    • 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
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/045Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • AHUMAN NECESSITIES
    • 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
    • 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
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • AHUMAN NECESSITIES
    • 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
    • A61K36/18Magnoliophyta (angiosperms)
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    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/287Chrysanthemum, e.g. daisy
    • AHUMAN NECESSITIES
    • 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
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/31Brassicaceae or Cruciferae (Mustard family), e.g. broccoli, cabbage or kohlrabi
    • AHUMAN NECESSITIES
    • 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
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/35Caprifoliaceae (Honeysuckle family)
    • A61K36/355Lonicera (honeysuckle)
    • AHUMAN NECESSITIES
    • 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
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/488Pueraria (kudzu)
    • AHUMAN NECESSITIES
    • 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
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/535Perilla (beefsteak plant)
    • AHUMAN NECESSITIES
    • 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
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/537Salvia (sage)
    • AHUMAN NECESSITIES
    • 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
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/539Scutellaria (skullcap)
    • AHUMAN NECESSITIES
    • 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
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/70Polygonaceae (Buckwheat family), e.g. spineflower or dock
    • A61K36/704Polygonum, e.g. knotweed
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    • A61K36/75Rutaceae (Rue family)
    • A61K36/752Citrus, e.g. lime, orange or lemon
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/83Thymelaeaceae (Mezereum family), e.g. leatherwood or false ohelo
    • A61K36/835Aquilaria
    • AHUMAN NECESSITIES
    • 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
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/85Verbenaceae (Verbena family)
    • AHUMAN NECESSITIES
    • 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
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/87Vitaceae or Ampelidaceae (Vine or Grape family), e.g. wine grapes, muscadine or peppervine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0043Nose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/02Nasal agents, e.g. decongestants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P11/06Antiasthmatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/08Antiallergic agents
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K2236/30Extraction of the material
    • A61K2236/37Extraction at elevated pressure or temperature, e.g. pressurized solvent extraction [PSE], supercritical carbon dioxide extraction or subcritical water extraction

Definitions

  • the invention specifically relates to a spray used for the prevention and treatment of allergic asthma combined with allergic rhinitis in children and adolescents.
  • Allergic rhinitis asthma (Combined Allergic Rhinitis and Asthma Syndrome.CARAS) refers to the simultaneous occurrence of clinical or subclinical upper respiratory tract allergy (allergic rhinitis) and lower respiratory tract allergic symptoms (asthma), both of which often coexist at the same time.
  • the immunological and pathological changes of the upper and lower respiratory tracts of allergic rhinitis and asthma are allergic inflammation of the nasal mucosa and bronchial mucosa, respectively. Inflammation of nasal mucosa and bronchial mucosa is very similar in terms of pathogenic factors, genetic changes, local pathological changes, abnormal immune function and pathogenesis.
  • the existing drugs are mainly treated with nasal hormones, oral or nasal antihistamines, etc., but the long-term effect is not very satisfactory, and the side effects of long-term use are relatively large.
  • the purpose of the present invention is to aim at the pathogenesis characteristics of children and adolescents with allergic asthma combined with allergic rhinitis, provide a portable and easy to use, can effectively improve the physical state of children with allergies, and can safely and effectively treat children with allergies Sprays for rhinitis and asthma.
  • a spray for the prevention and treatment of children and adolescents with allergic asthma and allergic rhinitis which includes pharmaceutical ingredients and auxiliary materials;
  • the pharmaceutical ingredients include volatile oil and Chinese medicine extracts:
  • the volatile oil is made from the following raw materials:
  • Annona seed volatile oil tangerine peel volatile oil, agarwood volatile oil, perilla volatile oil, honeysuckle volatile oil, borneol;
  • the Chinese medicine extract is prepared from the following raw materials:
  • the above-mentioned spray for the prevention and treatment of allergic asthma combined with allergic rhinitis in children and adolescents which includes pharmaceutical ingredients and auxiliary materials;
  • the pharmaceutical ingredients include volatile oil and Chinese medicine extracts: the volatile oil is prepared from the following raw materials:
  • the Chinese medicine extract is prepared from the following raw materials:
  • the above-mentioned spray for the prevention and treatment of allergic asthma combined with allergic rhinitis in children and adolescents which includes pharmaceutical ingredients and auxiliary materials;
  • the pharmaceutical ingredients include volatile oil and Chinese medicine extracts: the volatile oil is prepared from the following raw materials:
  • the Chinese medicine extract is prepared from the following raw materials:
  • auxiliary materials include ethanol, 1,3-propanediol, and purified water.
  • the volume ratio of 1,3-propanediol and purified water is 1-2:1-2:10.
  • the above-mentioned spray for the prevention and treatment of allergic asthma combined with allergic rhinitis in children and adolescents wherein the weight percentage of the pharmaceutical ingredients is 5-15%.
  • the spray for the prevention and treatment of allergic asthma in children and adolescents combined with allergic rhinitis according to the present invention, the essential oil of annona seed, the essential oil of tangerine peel, the essential oil of agarwood, the essential oil of perilla and the essential oil of honeysuckle all adopt steam distillation or super Extracted by critical extraction method.
  • extracting by steam distillation add 8 to 10 times the amount of water, use steam distillation device, extract for 2 hours, and collect the volatile oil.
  • the preparation method of the traditional Chinese medicine extract includes the following steps:
  • the preparation method of traditional Chinese medicine extract includes the following steps:
  • the invention uses white mustard seeds after long-term tests, which are pungent, warm and non-toxic. Go nose. Mainly eliminates kidney evil qi, helps nine orifices, improves eyes and ears, warms the lungs, eliminates phlegm and promotes qi. It is used for cold phlegm, asthma and cough, chest pain, phlegm stagnation in the meridian, numbness and pain of joints, phlegm dampness flow, swollen syringe and poison.
  • Chrysanthemum belongs to lung and liver meridian. It has the effects of dispelling wind-heat, calming the liver and improving eyesight, clearing away heat and detoxification. Indications: wind-heat and cold, fever, headache, dim eyesight, clearing wind and heat, clearing liver and fire, clearing heat and detoxification, etc.
  • Vitex quinquefolia has a pungent, bitter taste and slightly cold in nature. Return to lung, bladder, liver meridian. Frivolity Shengsan This product can disperse wind, clear away heat from slight cold, frivolity ascends, mainly disperses the evil of the head and face, has the effect of dispelling wind and relieving pain, and is used to treat exogenous wind-heat, headache and dizziness.
  • the invention is innovatively added with Maoyan berry tea, which is a vine tea variety that grows and multiplies in the specific geographical and climatic environment of Zhangjiajie, and belongs to a deciduous vine (Vitis).
  • the plant contains a natural plant cream
  • the active ingredient is mainly flavonoids, containing flavonoid crude protein 12.8 ⁇ 13.8, the average content of total flavonoids is ⁇ 6%, the highest detected content is 9.37%, which is all found so far Plants have the highest content of flavonoids, so they are called the “king of flavonoids” (flavonoids are known as "vascular scavengers” in medical circles, and they are the new favorite for the prevention of cardiovascular and cerebrovascular diseases).
  • the main flavonoids of Maoyan Berry Tea, dihydroxymycin has anti-bacterial and anti-inflammatory properties, clearing away heat and detoxification, relieving pain, reducing swelling, moistening throat and relieving cough, Improve human immunity, anti-allergic and other functions.
  • Pueraria lobata sweet, pungent, and cold. It has the functions of relieving muscles and reducing fever, removing rash, producing body fluid to quench thirst, and promoting Yang to stop diarrhea. It is often used for symptoms of fever, strong nape and back pain, impervious measles, thirst due to fever, yin deficiency to reduce thirst, heat diarrhea and heat dysentery, spleen deficiency and diarrhea.
  • Scutellaria baicalensis is used for heat-clearing, detoxifying and dampness, mainly treating febrile diseases, for children's body heat, used for damp heat, chest tightness, thirst and unwilling to drink, etc.
  • Xanthium is pungent, bitter, warm in nature, and poisonous. Return to the lung meridian. It has the functions of dispersing wind, removing dampness, and relieving pain. Indications: dispersing wind-cold, clearing nose and orifices, and dispelling rheumatism.
  • Ephedra mainly contains ephedrine, which is warm in nature, pungent in taste and slightly bitter. It has the effects of sweating and dispelling cold, promoting lung and asthma, diuresis and swelling. It can treat cold, cold, chest tightness, cough, wind swelling, bronchial asthma and other diseases.
  • Polygonum cuspidatum has a slightly bitter taste, slightly cold in nature, and belongs to the liver, gallbladder and lung meridians. It has the German effect of eliminating dampness and relieving yellow, clearing heat and detoxification, dispelling blood stasis and relieving pain, relieving cough and resolving phlegm. It can be used for lung-heat cough, rheumatism arthralgia, carbuncle swelling and sore toxin, water and fire burns, amenorrhea, symptom and rash injuries.
  • Salvia miltiorrhiza contains tanshinone, which is a strong meridian, which has the equivalent functions of removing blood stasis, regenerating new life, and promoting blood circulation.
  • the addition of salvia in the present invention can help promote blood circulation and has a better auxiliary effect on lung asthma and allergies.
  • the present invention adopts the volatile oil components of the preferred composition and the preferred traditional Chinese medicine extract components, and has the functions of dispelling wind and resuscitation, relieving the lungs and relieving asthma, dispelling wind, and expelling evil spirits.
  • Detoxification, cooling blood and promoting blood circulation, etc. can relieve external evils, clear the lung orifices, and achieve the effect of clearing the nose orifices. It has a good anti-allergic asthma and rhinitis effect, and through volatile components and traditional Chinese medicine extracts Nasal spray is easier to absorb until the capillaries of the nose and lungs, and the effect is quicker.
  • the volatile oil of annona seed, the volatile oil of tangerine peel, the volatile oil of agarwood, the volatile oil of perilla, and the volatile oil of honeysuckle are all obtained by the following methods:
  • a spray for the prevention and treatment of children and adolescents with allergic asthma combined with allergic rhinitis which includes pharmaceutical ingredients and auxiliary materials (ethanol:1,3-propanediol:purified water volume ratio 1:2:10); the pharmaceutical ingredients account for The weight percentage of the volatile oil is 8%; the pharmaceutical ingredients are made of volatile oil and traditional Chinese medicine extracts: the volatile oil is obtained by combining the following components:
  • Annona seed volatile oil 9g tangerine peel volatile oil 6g, agarwood volatile oil 3g, perilla volatile oil 6g, honeysuckle volatile oil 6g, and borneol 1g;
  • the Chinese medicine extract is prepared from the following raw materials:
  • the described Chinese medicine extracts are all prepared by the following methods:
  • the weight ratio take 10g of white mustard seed, 18g of chrysanthemum, 10g of vitex, 15g of Maoyanberry tea, 15g of kudzu root, 12g of scutellaria, 15g of dense ephedra, 6g of fried cocklebur, 6g of knotweed and 6g of salvia.
  • a spray for the prevention and treatment of children and adolescents with allergic asthma combined with allergic rhinitis which includes pharmaceutical ingredients and auxiliary materials (ethanol:1,3-propanediol:purified water volume ratio 1:2:10); the pharmaceutical ingredients account for The weight percentage of the volatile oil is 8%; the pharmaceutical ingredients are made of volatile oil and traditional Chinese medicine extracts: the volatile oil is obtained by combining the following components:
  • Annona seed volatile oil 3g tangerine peel volatile oil 6g, agarwood volatile oil 1g, perilla volatile oil 6g, honeysuckle volatile oil 6g, borneol 1g;
  • the Chinese medicine extract is prepared from the following raw materials:
  • the described Chinese medicine extracts are all prepared by the following methods:
  • the weight ratio take 5g of white mustard seed, 18g of chrysanthemum, 10g of vitex, Maoyanberry tea 5g, kudzu root 15g, scutellaria 12g, dense ephedra 15g, fried cocklebur 6g, polygonum cuspidatum 6g and salvia 3g, for the first time Adding 10 times the total weight of the medicinal materials with water, decocting and extracting for 2 hours, adding 8 times the total weight of the medicinal materials for the second time, decocting and extracting for 1 hour, combining the extracts, and concentrating to obtain the extract.
  • a spray for the prevention and treatment of children and adolescents with allergic asthma combined with allergic rhinitis which includes pharmaceutical ingredients and auxiliary materials (ethanol:1,3-propanediol:purified water volume ratio 1:2:10); the pharmaceutical ingredients account for The weight percentage of is 8%; the pharmaceutical ingredient is volatile oil: the volatile oil is obtained by combining the following components:
  • Annona seed volatile oil 9g tangerine peel volatile oil 6g, agarwood volatile oil 2g, perilla volatile oil 6g, honeysuckle volatile oil 6g, and borneol 1g.
  • a spray for the prevention and treatment of children and adolescents with allergic asthma combined with allergic rhinitis which includes pharmaceutical ingredients and auxiliary materials (ethanol:1,3-propanediol:purified water volume ratio 1:2:10); the pharmaceutical ingredients account for The weight percentage is 8%; the Chinese medicine extract is made from the following raw materials:
  • the described Chinese medicine extracts are all prepared by the following methods:
  • the weight ratio take 10g of white mustard seed, 18g of chrysanthemum, 10g of vitex, 15g of Maoyanberry tea, 15g of kudzu root, 12g of scutellaria, 15g of dense ephedra, 6g of fried cocklebur, 6g of knotweed and 6g of salvia.
  • test cases for allergic asthma combined with allergic rhinitis refer to the diagnostic criteria for allergic asthma and allergic rhinitis (diagnostic criteria for allergic asthma: refer to the "Guidelines for the Prevention and Treatment of Bronchial Asthma" formulated by the Asthma Group of the Respiratory Branch of the Chinese Medical Association (2008) "Selected 40 patients with allergic asthma and allergic rhinitis randomly divided into the treatment group of Example 1, Example 2 and the control group 1, the control group 2 control group. 40 patients with allergic asthma and allergic rhinitis, 22 males and females There were 18 cases, aged 3-15 years, with an average of 8 ⁇ 1.2 years old. There was no statistical difference in gender, age, and course of disease between the two groups.
  • Treatment method The treatment group was sprayed with the sprays of Example 1 and Example 2 every day, 3 times a day, 2 ml each time.
  • the control group 1 and the control group 2 were sprayed with the sprays of the control group 1 and the control group 2 respectively every day, 3 times a day, 2 ml each time.
  • the treatment effect was evaluated after 3 months of medication.
  • 1Asthma control score 25 points for complete asthma control, 20-24 points for good asthma control, and less than 20 points for uncontrolled asthma.
  • 2Rhinitis symptom scoring standard A. Refer to the allergic rhinitis scoring standard in "Allergic Rhinitis Handling Pocket Reference 2009" to evaluate the patient's symptoms.
  • RQLQ score scale score before and after treatment.
  • 4Evaluation index of the curative effect of allergic rhinitis the improvement rate is calculated by [(total score before treatment-total score after treatment)/total score before treatment]*100%, among which, markedly effective ⁇ 51%; effective ⁇ 50%, ⁇ 21%; Invalid ⁇ 20%.
  • 5Total effective rate Effective: Asthma score is 20 points or more, meanwhile, allergic rhinitis curative effect evaluation index ⁇ 51%; improvement: Asthma score is 20-24 points, and allergic rhinitis curative effect evaluation index ⁇ 50%, ⁇ 21% ; Invalid: Asthma ⁇ 20 points, meanwhile, the evaluation index of curative effect of allergic rhinitis ⁇ 20%.
  • Results The collected data is statistically analyzed using SPSS 18.0 software. The results of asthma control score and rhinitis symptom score are shown in Table 1, and the results of RQLQ score and serum total IgE index are shown in Table 2. The results show that Example 1 and Example 2 of the present invention have better efficacy in treating asthma and rhinitis compared to Examples 1 and 2 of the control group.
  • the effective rate of Example 1 of the present invention is 90%, and the effective rate of the treatment group of Example 2 is 80%, which is significantly higher than that of the control group 1 (effective rate of 20%) and control group 2 (effective rate of 30%).
  • the specific results are shown in Table 3. .
  • the spray provided by the present invention has a good therapeutic effect on allergic asthma combined with allergic rhinitis
  • the present invention is effective in reducing the volatile oil of annon-apple seeds, scented volatile oil, and white mustard seeds.
  • the content of Cranberry and Maoyanberry tea the therapeutic effect is reduced.
  • the spray dose is the same, when compared with a single volatile oil component or a single Chinese medicine extract component, when the volatile oil and the Chinese medicine extract are used together, it shows a more significant effect on the treatment of allergic asthma and allergic rhinitis, indicating that each component Supplement each other and play a synergistic role.
  • IL-5 and IL-13 kits were purchased from Hangzhou Lianke Biotechnology Co., Ltd.
  • Test drugs Example 1, Example 2, Control Example 1 and Control Example 2, which were administered by spray;
  • mice 4-6 weeks old, female, SPF grade, provided by Qinglongshan Animal Breeding Farm, Jiangning District, Nanjing.
  • mice were randomly divided into 6 groups, normal group, model group, example 1, example 2, control group 1, and control group 2.
  • model group, example 1, example 2, control group 1 and control group 2 were intraperitoneally injected with 0.4ml OVA sensitizing solution (from OVA 2g, aluminum hydroxide gel 20ml, physiological saline 20ml on day 0 and day 7, respectively).
  • OVA sensitizing solution from OVA 2g, aluminum hydroxide gel 20ml, physiological saline 20ml on day 0 and day 7, respectively.
  • the normal group was intraperitoneally injected with the same amount of saline.
  • the 5% OVA solution was sprayed and inhaled for 30 minutes for excitation, and continuously sprayed for 5 days, once a day, for 30 minutes each time.
  • the mice in the normal group were atomized with the same amount of normal saline.
  • Example 1 Example 2, the control group 1 and the control group 2 were all administered by atomized spray, 2 ml each time, 3 times a day, and sprayed continuously for 7 days.
  • Diagnosis Western medicine: Allergic rhinitis with asthma
  • Example 1 Use the spray of Example 1 to spray, 3 times a day, 2 mL each time.
  • the patient After 4 weeks of continuous spray treatment, the patient will be re-diagnosed for nasal itching, nasal congestion, night cough and asthma, better than before, good appetite, bowel movements, and the tongue is dull and red.
  • Diagnosis Western medicine: Allergic rhinitis combined with asthma.
  • Example 1 Use the spray of Example 1 to spray, 3 times a day, 2 mL each time.

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Abstract

Il est divulgué un agent de pulvérisation pour la prévention et le traitement de l'asthme allergique combiné à la rhinite allergique chez les enfants et les adolescents. L'agent de pulvérisation comprend des ingrédients pharmaceutiques et des matériaux auxiliaires. Les ingrédients pharmaceutiques comprennent des huiles volatiles et un extrait de médecine traditionnelle chinoise, les huiles volatiles comprenant de l'huile volatile de graines d'Annona squamosa, de l'huile volatile de Citri reticulatae pericarpium, de l'huile volatile d'Aquilariae lignum resinatum, de l'huile volatile de Perillae fructus, de l'huile volatile de Lonicerae japonicae flos et du Borneolum syntheticum ; et l'extrait de médecine traditionnelle chinoise est préparé à partir de Sinapis alba, de Chrysanthemi flos, de Viticis fructus, d'Ampelopsis grossedentata, de racine de Puerariae lobatae, de racine de Scutellariae, de préparation d'herbe d'Ephedrae, de Xanthii fructus frit, de rhizome et de racine de Polygoni cuspidati et de rhizome et de racine de Salviae miltiorrhizae.
PCT/CN2020/116449 2019-11-25 2020-09-21 Agent de pulvérisation pour la prévention et le traitement de l'asthme allergique combiné à une rhinite allergique chez les enfants et adolescents WO2021103777A1 (fr)

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