WO2021103777A1 - Spraying agent for preventing and treating allergic asthma combined with allergic rhinitis in children and teenagers - Google Patents

Spraying agent for preventing and treating allergic asthma combined with allergic rhinitis in children and teenagers 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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French (fr)
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/en

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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)
    • A61K36/185Magnoliopsida (dicotyledons)
    • 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
    • AHUMAN NECESSITIES
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    • 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)
    • A61K36/75Rutaceae (Rue family)
    • A61K36/752Citrus, e.g. lime, orange or lemon
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • 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)
    • A61K36/83Thymelaeaceae (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
    • A61P11/00Drugs for disorders of the respiratory system
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • 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
    • A61K2236/37Extraction 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.

Abstract

Disclosed is a spraying agent for preventing and treating allergic asthma combined with allergic rhinitis in children and teenagers. The spraying agent comprises pharmaceutical ingredients and auxiliary materials. The pharmaceutical ingredients comprise volatile oils and a traditional Chinese medicine extract, wherein the volatile oils comprise Annona squamosa seed volatile oil, Citri reticulatae pericarpium volatile oil, Aquilariae lignum resinatum volatile oil, Perillae fructus volatile oil, Lonicerae japonicae flos volatile oil and Borneolum syntheticum; and the traditional Chinese medicine extract is prepared from Sinapis alba, Chrysanthemi flos, Viticis fructus, Ampelopsis grossedentata, Puerariae lobatae radix, Scutellariae radix, Ephedrae herba preparata, fried Xanthii fructus, Polygoni cuspidati rhizoma et radix and Salviae miltiorrhizae radix et rhizoma.

Description

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Spray for preventing and treating allergic asthma combined with allergic rhinitis in children and adolescents 技术领域Technical field
本发明具体涉及一种用于儿童、青少年过敏性哮喘合并过敏性鼻炎防治的喷雾剂。The invention specifically relates to a spray used for the prevention and treatment of allergic asthma combined with allergic rhinitis in children and adolescents.
背景技术Background technique
过敏性鼻炎哮喘(Combined Allergic Rhinitis and Asthma Syndrome.CARAS)是指同时发生的临床或亚临床的上呼吸道过敏(过敏性鼻炎)和下呼吸道的过敏性症状(哮喘),两者往往同时并存。过敏性鼻炎哮喘征的上、下呼吸道的免疫学和病理学改变分别是发生在鼻黏膜和支气管黏膜的过敏性炎症。鼻黏膜和支气管黏膜的炎症在发病诱因、遗传学改变、局部的病理学改变、机体免疫功能异常和发病机制等方面均非常相似。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.
儿童、青少年过敏性哮喘合并过敏性鼻炎发病率增高,反复发作可损害肺功能及加重气道损伤等,对患儿的学习、日常活动甚至生长发育造成严重影响,也给家庭和社会带来沉重负担。The incidence of allergic asthma combined with allergic rhinitis in children and adolescents is increased. Repeated attacks can damage lung function and aggravate airway damage. It has a serious impact on children's learning, daily activities and even growth and development, and it also brings heavy burden to family and society. burden.
现有药物主要应用鼻用激素、口服或鼻用抗组胺药等进行治疗,远期效果不是很理想,而且长期应用的副作用较大。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.
发明内容Summary of the invention
本发明的目的在于针对儿童、青少年过敏性哮喘合并过敏性鼻炎的病机特点,提供一种携带、使用方便,能够有效地改善过敏患儿的体质状态,能安全、有效的治疗患儿过敏性鼻炎和哮喘的喷雾剂。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.
为实现以上目的,本发明采用的具体技术方案如下:In order to achieve the above objectives, the specific technical solutions adopted by the present invention are as follows:
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,它包括药物成分和辅料;所述的药物成分包括挥发油和中药提取物:所述的挥发油由下列原料制得: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:
番荔枝种子挥发油、陈皮挥发油、沉香挥发油、紫苏挥发油、金银花挥发油、冰片;Annona seed volatile oil, tangerine peel volatile oil, agarwood volatile oil, perilla volatile oil, honeysuckle volatile oil, borneol;
中药提取物由下列原料制得:The Chinese medicine extract is prepared from the following raw materials:
白芥子、菊花、蔓荆子、茅岩莓茶、葛根、黄芩、密制麻黄、炒苍耳子、虎杖和丹参。White mustard seeds, chrysanthemum, vitex, Maoyan berry tea, kudzu root, scutellaria, dense ephedra, fried cocklebur, knotweed and salvia.
作为优选方案,以上所述的用于儿童、青少年过敏性哮喘合并过敏性鼻炎防治的喷雾剂,它包括药物成分和辅料;As a preferred solution, 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;
所述的药物成分包括挥发油和中药提取物:所述的挥发油由下列原料制得:The pharmaceutical ingredients include volatile oil and Chinese medicine extracts: the volatile oil is prepared from the following raw materials:
番荔枝种子挥发油3~12份、陈皮挥发油3~12份、沉香挥发油1~6份、紫苏挥发油2~8份、金银花挥发油3~12份、冰片1~3份;Annona seed volatile oil 3-12 parts, tangerine peel volatile oil 3-12 parts, agarwood volatile oil 1-6 parts, perilla volatile oil 2-8 parts, honeysuckle volatile oil 3-12 parts, borneol 1-3 parts;
中药提取物由下列原料制得:The Chinese medicine extract is prepared from the following raw materials:
白芥子5~15份、菊花6~18份、蔓荆子5~15份、茅岩莓茶5~15份、葛根5~15份、 黄芩6~18份、密制麻黄5~15份、炒苍耳子3~9份、虎杖3~9份和丹参3~9份。5-15 parts of white mustard seeds, 6-18 parts of chrysanthemum, 5-15 parts of vitex, 5-15 parts of Maoyanberry tea, 5-15 parts of kudzu root, 6-18 parts of scutellaria, 5-15 parts of dense ephedra, Stir-fried Xanthium spp. 3-9 parts, Polygonum cuspidatum 3-9 parts, and Salvia miltiorrhiza 3-9 parts.
作为优选方案,以上所述的用于儿童、青少年过敏性哮喘合并过敏性鼻炎防治的喷雾剂,它包括药物成分和辅料;As a preferred solution, 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;
所述的药物成分包括挥发油和中药提取物:所述的挥发油由下列原料制得:The pharmaceutical ingredients include volatile oil and Chinese medicine extracts: the volatile oil is prepared from the following raw materials:
番荔枝种子挥发油9份、陈皮挥发油6份、沉香挥发油3份、紫苏挥发油6份、金银花挥发油6份、冰片1份;9 parts of annona seed essential oil, 6 parts of tangerine peel essential oil, 3 parts of agarwood essential oil, 6 parts of perilla essential oil, 6 parts of honeysuckle essential oil, 1 part of borneol;
中药提取物由下列原料制得:The Chinese medicine extract is prepared from the following raw materials:
白芥子10份、菊花18份、蔓荆子10份、茅岩莓茶15份、葛根15份、黄芩12份、密制麻黄15份、炒苍耳子6份、虎杖6份和丹参6份。10 parts of white mustard seeds, 18 parts of chrysanthemum, 10 parts of vitex, 15 parts of Maoyan berry tea, 15 parts of Pueraria lobata, 12 parts of scutellaria, 15 parts of dense ephedra, 6 parts of sauteed cocklebur, 6 parts of Polygonum cuspidatum, and 6 parts of Danshen .
本发明所述的用于儿童、青少年过敏性哮喘合并过敏性鼻炎防治的喷雾剂,其中辅料包括乙醇、1,3-丙二醇、纯化水。其中1,3-丙二醇和纯化水体积比为1~2∶1~2∶10。The spray for the prevention and treatment of allergic asthma combined with allergic rhinitis in children and adolescents of the present invention, wherein the 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.
作为优选方案,以上所述的用于儿童、青少年过敏性哮喘合并过敏性鼻炎防治的喷雾剂,其中药物成分的重量百分含量为5~15%。As a preferred solution, 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%.
本发明所述的用于儿童、青少年过敏性哮喘合并过敏性鼻炎防治的喷雾剂,所述的番荔枝种子挥发油、陈皮挥发油、沉香挥发油、紫苏挥发油和金银花挥发油均采用水蒸气蒸馏法或超临界萃取法提取得到。其中水蒸气蒸馏法提取时,加入8~10倍量的水,采用水蒸气蒸馏装置,提取2小时,收集得到挥发油。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. When 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.
本发明所述的用于儿童、青少年过敏性哮喘合并过敏性鼻炎防治的喷雾剂,中药提取物的制备方法包括的步骤有:In the spray used for the prevention and treatment of allergic asthma combined with allergic rhinitis in children and adolescents of the present invention, the preparation method of the traditional Chinese medicine extract includes the following steps:
按重量配比,取白芥子、菊花、蔓荆子、茅岩莓茶、葛根、黄芩、密制麻黄、炒苍耳子、虎杖和丹参,加入药材总重量6~15倍量的水,煎煮提取1~2次,每次1~1.5小时,合并提取液,浓缩即得。According to the weight ratio, take white mustard seeds, chrysanthemums, vitex seeds, Maoyan berry tea, kudzu root, scutellaria, dense ephedra, fried cocklebur, knotweed and salvia, add 6-15 times the total weight of the medicinal materials with water, and decoct Boil and extract 1 to 2 times, 1 to 1.5 hours each time, combine the extracts and concentrate to obtain.
作为优选,中药提取物的制备方法包括的步骤有:Preferably, the preparation method of traditional Chinese medicine extract includes the following steps:
按重量配比,取白芥子、菊花、蔓荆子、茅岩莓茶、葛根、黄芩、炒苍耳子、密制麻黄、虎杖和丹参,第一次加入药材总重量10倍量的水,煎煮提取1.5小时,第二次加入药材总重量8倍量的水,煎煮提取1小时,合并提取液,浓缩即得。According to the weight ratio, take white mustard seeds, chrysanthemums, vines, Maoyan berry tea, kudzu root, scutellaria, fried cocklebur seeds, dense ephedra, knotweed and salvia, and add water 10 times the total weight of the medicinal materials for the first time. Decoction and extraction for 1.5 hours, add water 8 times the total weight of the medicinal material for the second time, decoction and extraction for 1 hour, combine the extracts, and concentrate to obtain.
本发明经过长期试验利用白芥子,白芥子味辛,温,无毒。归鼻。主除肾邪气,利九窍,明耳目,安中温肺豁痰利气。用于寒痰喘咳,胸胁胀痛,痰滞经络,关节麻木、疼痛,痰湿流注,阴疽肿毒。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.
菊花归肺、肝经。具有效疏散风热,平肝明目,清热解毒等功效。主治:风热感冒,发热头痛,目赤昏花,善疏风清热,清肝泻火,清热解毒等。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.
蔓荆子味辛、苦,性微寒。归肺、膀胱、肝经。轻浮升散本品辛能散风,微寒清热, 轻浮上行,主散头面之邪,有祛风止痛之效,用治外感风热,头痛头晕。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.
本发明创新的添加有茅岩莓茶,它是一种在张家界特定的地理、气候环境中生长、繁衍的藤茶品种,属落叶藤本植物(葡萄科)。经检测鉴定,该植物含有一种天然植物霜,其有效成分主要是黄酮,含黄酮粗蛋白12.8~13.8,总黄酮平均含量为≥6%,最高检测含量为9.37%,是目前所有被发现的植物中黄酮含量最高,故被称为″黄酮之王″(黄酮~~医学界誉为″血管清道夫″,是预防心脑血管疾病的新宠)。富含17种氨基酸和钾、钙、铁、锌、硒等14种微量元素,茅岩莓茶的黄酮主要成分二氢杨霉素具有杀菌抗炎、清热解毒、镇痛消肿润喉止咳、提高人体免疫力、抗过敏等功能。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). After testing and identification, 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). It is rich in 17 kinds of amino acids and 14 kinds of trace elements including potassium, calcium, iron, zinc and selenium. 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.
葛根,甘、辛,凉。有解肌退热,透疹,生津止渴,升阳止泻之功。常用于表证发热,项背强痛,麻疹不透,热病口渴,阴虚消渴,热泻热痢,脾虚泄泻。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.
黄芩清热解毒燥湿,主治温热病,针对小孩体热质,用于湿温发热、胸闷、口渴不欲饮等。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.
苍耳子,味辛、苦,性温,有毒。归肺经。具有散风除湿、通窍止痛的功能,主治:发散风寒,通鼻窍,祛风湿。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.
麻黄主含麻黄碱,其性温,味辛、微苦,有发汗散寒、宣肺平喘、利水消肿的功效,可治疗风寒感冒、胸闷喘咳风水浮肿、支气管哮喘等病症。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.
虎杖味微苦,性微寒,归肝、胆、肺经。具有利湿退黄,清热解毒,散瘀止痛,止咳化痰德国功效,可用于肺热咳嗽,风湿痹痛,痈肿疮毒,水火烫伤,经闭,症瘕,趺打损伤。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.
丹参含丹参酮,为强壮性通经剂,有祛瘀、生新、活血等效用,本发明添加丹参有助于活血作用,对肺部哮喘和过敏等有较好的辅助作用。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.
以上各药味组方与特定挥发油配伍,可达到散风除湿、通窍、解毒、抗过敏、宣肺平喘、利湿健脾等功效,对儿童、青少年过敏性哮喘和过敏性鼻炎具有很好的防治作用。The above formulas of various medicinal flavors are compatible with specific volatile oils, which can achieve the effects of dispelling wind and dehumidification, resuscitating, detoxifying, anti-allergic, promoting lung and asthma, promoting dampness and strengthening spleen, etc. It is very good for children and adolescents with allergic asthma and allergic rhinitis. Control effect.
有益效果:本发明根据儿童、青少年过敏性哮喘合并过敏性鼻炎的病机特点,采用优选组成的挥发油成分和优选的中药提取物组分,具有散风通窍,宣肺平喘,疏风,驱邪,解毒凉血活血等特点,可使外邪得解,肺窍得通,达到宣通鼻窍之功效,具有很好的抗过敏性哮喘合并鼻炎的功效,且通过挥发性成分和中药提取物鼻腔喷雾,更易直到鼻部毛细血管和肺部吸收,见效快。Beneficial effects: According to the pathogenesis characteristics of children and adolescents with allergic asthma combined with allergic rhinitis, 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.
具体实施方式Detailed ways
下面结合具体实施例进一步阐明本发明,应理解这些实施例仅用于说明本发明而不用于限制本发明的范围,在阅读了本发明之后,本领域技术人员对本发明的各种等价形式的修改均落于本申请所附权利要求所限定的范围。The present invention will be further clarified below in conjunction with specific examples. It should be understood that these examples are only used to illustrate the present invention and not to limit the scope of the present invention. After reading the present invention, those skilled in the art will understand various equivalent forms of the present invention. All modifications fall within the scope defined by the appended claims of this application.
以下实施例中,番荔枝种子挥发油、陈皮挥发油、沉香挥发油、紫苏挥发油、金银花挥发油均是通过以下方法制各得到:In the following examples, 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:
分别取干燥的番荔枝种子、陈皮、沉香、紫苏叶或金银花,分别置于挥发油提取器中,分别加入10倍量的水,采用水蒸气蒸馏法,提取2小时,分别收集得到荔枝种子挥发油、陈皮挥发油、沉香挥发油、紫苏挥发油、金银花挥发油。Take the dried annona seeds, tangerine peel, agarwood, perilla leaves or honeysuckle, respectively, and place them in a volatile oil extractor, add 10 times the amount of water, and use steam distillation to extract for 2 hours, and then collect the lychee seed volatile oil. , Tangerine peel volatile oil, agarwood volatile oil, perilla volatile oil, honeysuckle volatile oil.
实施例1Example 1
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,它包括药物成分和辅料(乙醇∶1,3-丙二醇∶纯化水体积比1∶2∶10);其中药物成分所占的重量百分比为8%;所述的药物成分由挥发油和中药提取物制成:所述的挥发油由下列组份组合得到: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:
番荔枝种子挥发油9g、陈皮挥发油6g、沉香挥发油3g、紫苏挥发油6g、金银花挥发油6g、冰片1g;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;
中药提取物由下列原料制得:The Chinese medicine extract is prepared from the following raw materials:
白芥子10g、菊花18g、蔓荆子10g、茅岩莓茶15g、葛根15g、黄芩12g、密制麻黄15g、炒苍耳子6g、虎杖6g和丹参6g。10g of white mustard seeds, 18g of chrysanthemum, 10g of vitex, 15g of Maoyan berry tea, 15g of kudzu root, 12g of scutellaria, 15g of dense ephedra, 6g of fried xanthium, 6g of knotweed and 6g of salvia.
所述的中药提取物均是通过以下方法制备得到:The described Chinese medicine extracts are all prepared by the following methods:
按重量配比,取白芥子10g、菊花18g、蔓荆子10g、茅岩莓茶15g、葛根15g、黄芩12g、密制麻黄15g、炒苍耳子6g、虎杖6g和丹参6g,第一次加入药材总重量10倍量的水,煎煮提取1.5小时,第二次加入药材总重量8倍量的水,煎煮提取1小时,合并提取液,浓缩即得提取物。According to 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. Add water 10 times the total weight of the medicinal materials, decoct and extract for 1.5 hours, add 8 times the total weight of the medicinal materials for the second time, decoct and extract for 1 hour, combine the extracts, and concentrate to obtain the extract.
实施例2Example 2
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,它包括药物成分和辅料(乙醇∶1,3-丙二醇∶纯化水体积比1∶2∶10);其中药物成分所占的重量百分比为8%;所述的药物成分由挥发油和中药提取物制成:所述的挥发油由下列组份组合得到: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:
番荔枝种子挥发油3g、陈皮挥发油6g、沉香挥发油1g、紫苏挥发油6g、金银花挥发油6g、冰片1g;Annona seed volatile oil 3g, tangerine peel volatile oil 6g, agarwood volatile oil 1g, perilla volatile oil 6g, honeysuckle volatile oil 6g, borneol 1g;
中药提取物由下列原料制得:The Chinese medicine extract is prepared from the following raw materials:
白芥子5g、菊花18g、蔓荆子5g、茅岩莓茶5g、葛根15g、黄芩12g、密制麻黄15g、炒苍耳子6g、虎杖6g和丹参6g。White mustard seeds 5g, chrysanthemum 18g, vitex 5g, Maoyan berry tea 5g, kudzu root 15g, scutellaria 12g, dense ephedra 15g, fried cocklebur 6g, polygonum cuspidatum 6g and salvia 6g.
所述的中药提取物均是通过以下方法制备得到:The described Chinese medicine extracts are all prepared by the following methods:
按重量配比,取白芥子5g、菊花18g、蔓荆子10g、茅岩莓茶5g、葛根15g、黄芩12g、密制麻黄15g、炒苍耳子6g、虎杖6g和丹参3g,第一次加入药材总重量10倍量的水,煎煮提取2小时,第二次加入药材总重量8倍量的水,煎煮提取1小时,合并提取液,浓缩即得提取物。According to 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.
对比实施例1Comparative Example 1
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,它包括药物成分和辅料(乙醇∶1,3-丙二醇∶纯化水体积比1∶2∶10);其中药物成分所占的重量百分比为8%;所述的药物成分为挥发油:所述的挥发油由下列组份组合得到: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:
番荔枝种子挥发油9g、陈皮挥发油6g、沉香挥发油2g、紫苏挥发油6g、金银花挥发油6g、冰片1g。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.
对比实施例2Comparative Example 2
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,它包括药物成分和辅料(乙醇∶1,3-丙二醇∶纯化水体积比1∶2∶10);其中药物成分所占的重量百分比为8%;中药提取物由下列原料制得: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:
白芥子10g、菊花18g、蔓荆子10g、茅岩莓茶15g、葛根15g、黄芩12g、密制麻黄15g、炒苍耳子6g、虎杖6g和丹参6g。10g of white mustard seeds, 18g of chrysanthemum, 10g of vitex, 15g of Maoyan berry tea, 15g of kudzu root, 12g of scutellaria, 15g of dense ephedra, 6g of fried xanthium, 6g of knotweed and 6g of salvia.
所述的中药提取物均是通过以下方法制备得到:The described Chinese medicine extracts are all prepared by the following methods:
按重量配比,取白芥子10g、菊花18g、蔓荆子10g、茅岩莓茶15g、葛根15g、黄芩12g、密制麻黄15g、炒苍耳子6g、虎杖6g和丹参6g,第一次加入药材总重量10倍量的水,煎煮提取1.5小时,第二次加入药材总重量8倍量的水,煎煮提取1小时,合并提取液,浓缩即得提取物。According to 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. Add water 10 times the total weight of the medicinal materials, decoct and extract for 1.5 hours, add 8 times the total weight of the medicinal materials for the second time, decoct and extract for 1 hour, combine the extracts, and concentrate to obtain the extract.
实施例3过敏性哮喘合并过敏性鼻炎的临床观察实验Example 3 Clinical observation experiment of allergic asthma combined with allergic rhinitis
(1)过敏性哮喘合并过敏性鼻炎被试病例选择:参照过敏性哮喘和过敏性鼻炎诊断标准(过敏性哮喘诊断标准:参考中华医学会呼吸病学分会哮喘学组制定的《支气管哮喘防治指南(2008)》选取40例过敏哮喘合并过敏性鼻炎患者随机分成实施例1、实施例2治疗组和对照组1,对照组2对照组。40例过敏哮喘合并过敏性鼻炎患者男22例,女18例,年龄3~15岁,平均8±1.2岁。两组被试患者性别、年龄、病程无统计学差异。(1) Selection of 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.
(3)治疗方法:治疗组每天分别喷实施例1和实施例2喷雾剂,每天3次,每次2毫升。对照组1和对照组2每天分别喷对照组1和对照组2的喷雾剂,每天3次,每次2毫升。用药3个月后进行治疗效果评测。(3) 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.
(4)治疗效果评价:治疗1个月后,观察治疗效果。(4) Evaluation of treatment effect: Observe the treatment effect after 1 month of treatment.
①哮喘控制评分标准:哮喘完全控制评分为25分,哮喘控制良好评分为20~24分,哮喘未控制评分为<20分。①Asthma control score: 25 points for complete asthma control, 20-24 points for good asthma control, and less than 20 points for uncontrolled asthma.
②鼻炎症状评分标准:A.参照《过敏性鼻炎处理袖珍参考2009》中的过敏性鼻炎评分标准评价患者的症状。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.
B.RQLQ评分量表:治疗前后进行评分。B. RQLQ score scale: score before and after treatment.
③血清总IgE检测:空腹静脉血,试剂盒检测IgE含量。③Detection of total serum IgE: fasting venous blood, test IgE content with kit.
④过敏性鼻炎疗效评价指标:改善率按[(治疗前总分-治疗后总分)/治疗前总分]*100%计算,其中,显效≥51%;有效≤50%,≥21%;无效≤20%。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%.
⑤总有效率:有效:哮喘评分为20分以上,同时,过敏性鼻炎疗效评价指标≥51%;好转:哮喘评分为20~24分,同时过敏性鼻炎疗效评价指标≤50%,≥21%;无效:哮喘<20分,同时过敏性鼻炎疗效评价指标≤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%.
(5)结果:采集的数据采用SPSS 18.0软件进行统计分析。哮喘控制评分、鼻炎症状评分结果如表1,RQLQ评分和血清总IgE指标结果如表2。结果表明本发明实施例1和实施例2相比对照组实施例1和2具有更好的治疗哮喘和鼻炎的功效。(5) 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.
本发明实施例1有效率为90%,实施例2治疗组的有效率为80%显著高于对照组1(有效率20%)和对照组2(有效率30%),具体结果见表3。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. .
表1治疗前后两组患者哮喘控制评分和鼻炎症状评分指标比较(分,
Figure PCTCN2020116449-appb-000001
)
Table 1 Comparison of asthma control score and rhinitis symptom score index between the two groups of patients before and after treatment (points,
Figure PCTCN2020116449-appb-000001
)
Figure PCTCN2020116449-appb-000002
Figure PCTCN2020116449-appb-000002
**与治疗前相比P<0.001,*与治疗前相比P<0.05**P<0.001 compared with before treatment, *P<0.05 compared with before treatment
表2治疗前后两组患者RQLQ评分和血清总IgE指标比较(分,
Figure PCTCN2020116449-appb-000003
)
Table 2 Comparison of RQLQ scores and serum total IgE indexes between the two groups of patients before and after treatment (points,
Figure PCTCN2020116449-appb-000003
)
Figure PCTCN2020116449-appb-000004
Figure PCTCN2020116449-appb-000004
Figure PCTCN2020116449-appb-000005
Figure PCTCN2020116449-appb-000005
**与治疗前相比P<0.001,*与治疗前相比P<0.05**P<0.001 compared with before treatment, *P<0.05 compared with before treatment
表3两组患者治疗总效果比较(例)Table 3 Comparison of the total treatment effect of the two groups of patients (cases)
组别 例数 有效 好转 无效 总有效率
实施例1 10 8 1 1 90%
实施例2 10 7 3 2 80%
对照实施例1 10 0 2 8 20%
对照实施例2 10 0 3 7 30%
Group Number of cases effective Get better invalid Total effective rate
Example 1 10 8 1 1 90%
Example 2 10 7 3 2 80%
Comparative Example 1 10 0 2 8 20%
Comparative Example 2 10 0 3 7 30%
.
通过以上临床试验结果表明,本发明提供的喷雾剂对过敏性哮喘合并过敏性鼻炎具有很好的治疗作用,并且通过对比实验发现,本发明在降低番荔枝种子挥发油沉、香挥发油和白芥子、蔓荆子和茅岩莓茶的含量时,治疗作用降低。在喷雾剂量相同时,与单个挥发油组份或单个中药提取物组份进行对比时,挥发油和中药提取物合用时,显示出更加显著的治疗过敏性哮喘合并过敏性鼻炎的功效,表明各组份相辅相成,起到了协同促进的作用。The above clinical test results show that the spray provided by the present invention has a good therapeutic effect on allergic asthma combined with allergic rhinitis, and through comparative experiments, it is found that the present invention is effective in reducing the volatile oil of annon-apple seeds, scented volatile oil, and white mustard seeds. When the content of Cranberry and Maoyanberry tea, the therapeutic effect is reduced. When 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.
实施例4对哮喘模型小鼠实验观察Example 4 Experimental observation on asthma model mice
(1)试剂及实验药物(1) Reagents and experimental drugs
IL-5、IL-13试剂盒购于杭州联科生物技术有限公司。IL-5 and IL-13 kits were purchased from Hangzhou Lianke Biotechnology Co., Ltd.
受试药物:实施例1,实施例2,对照实施例1和对照实施例2,采用喷雾给药;Test drugs: Example 1, Example 2, Control Example 1 and Control Example 2, which were administered by spray;
(2)实验动物(2) Experimental animals
km小鼠,周龄4-6周,雌性,SPF级,由南京市江宁区青龙山动物繁殖场提供。km mice, 4-6 weeks old, female, SPF grade, provided by Qinglongshan Animal Breeding Farm, Jiangning District, Nanjing.
(3)实验方法(3) Experimental method
(3.1)造模(3.1) Modeling
将小鼠随机分为6组,正常组、模型组、实施例1、实施例2、对照组1和对照组2。采购后模型组、实施例1、实施例2、对照组1和对照组2分别于第0天、第7天腹腔注射0.4mlOVA致敏液(由OVA2g,氢氧化铝凝胶20ml,生理盐水20ml配制)致敏,正常组腹腔注射等量生理盐水。并于第14天开始予5%OVA溶液雾化吸入30min激发,连续雾化5d,每日1次,每次30min。正常组小鼠予等量的生理盐水雾化。The mice were randomly divided into 6 groups, normal group, model group, example 1, example 2, control group 1, and control group 2. After purchase, 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). Preparation) for sensitization, the normal group was intraperitoneally injected with the same amount of saline. And on the 14th day, 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.
(3.1)给药(3.1) Administration
实施例1、实施例2、对照组1和对照组2均采用雾化喷雾给药,每次2毫升,每日3次,连续喷雾7天。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.
(3.2)实验标本采集(3.2) Experimental specimen collection
末次雾化24h后(期间小鼠禁食不禁水),麻醉后眼球取血,然后颈椎脱臼法处死。其中4只取肺泡灌洗液,放于-80℃冻存;另外4只剪取右中肺置于4%多聚甲醛中固定,剩余肺组织放于-80℃备用。24 hours after the last nebulization (during the mice fasting without water), blood was taken from the eyeball after anesthesia, and then sacrificed by cervical dislocation. Four of them were taken with alveolar lavage fluid and stored at -80°C; the other four were cut from the right middle lung and fixed in 4% paraformaldehyde, and the remaining lung tissue was stored at -80°C for use.
(4)实验结果(4) Experimental results
(4.1)肺病理炎症情况:与正常组相比,模型组支气管管壁明星增厚、肺泡壁增厚、炎症细胞浸润明显。在给予本发明实施例1和实施例2喷雾剂后,小鼠肺组织炎症浸润、管腔分泌物等情况明显减轻,且实施例1效果优于实施例2,而对比实施例1和2小鼠肺组织炎症浸润、管腔分泌物等情况有所减轻,但不明显。(4.1) Pulmonary pathological inflammation: Compared with the normal group, the bronchial tube wall of the model group is thickened, the alveolar wall is thickened, and the inflammatory cell infiltration is obvious in the model group. After the sprays of Example 1 and Example 2 of the present invention were administered, the lung tissue inflammation infiltration and luminal secretion of mice were significantly reduced, and the effect of Example 1 was better than that of Example 2, while the comparative examples 1 and 2 were less effective. Inflammation infiltration and luminal secretion of rat lung tissue were alleviated, but not obvious.
(4.2)肺泡灌洗液中IL-4、IL-5、IL-13炎症因子表达情况。(4.2) The expression of IL-4, IL-5 and IL-13 inflammatory factors in alveolar lavage fluid.
具体结果如表4所示,和正常组相比,模型组IL-4、IL-13和IL-5水平明显升高,给予实施例1和2喷雾剂之后IL-4、IL-13和IL-5水平明显降低,且差异具有统计学意义(P<0.05)。而对比实施例1和2具有一定的降低IL-13和IL-5水平的作用,但是没有具有统计学意义(P>0.05)。The specific results are shown in Table 4. Compared with the normal group, the levels of IL-4, IL-13 and IL-5 in the model group were significantly increased. After the sprays of Examples 1 and 2 were given, IL-4, IL-13 and IL -5 levels were significantly reduced, and the difference was statistically significant (P<0.05). Comparative Examples 1 and 2 have a certain effect on reducing the levels of IL-13 and IL-5, but they are not statistically significant (P>0.05).
表4各组IL-4、IL-5、IL-13炎症因子表达情况Table 4 The expression of IL-4, IL-5, IL-13 inflammatory factors in each group
组别Group IL-5(pg/mL)IL-5(pg/mL) IL-4(ng/mL)IL-4(ng/mL) IL-13(pg/mL)IL-13(pg/mL)
正常组normal group 5353 23twenty three 4343
模型组Model group 138#138# 43#43# 68#68#
实施例1Example 1 60**60** 26*26* 46*46*
实施例2Example 2 63**63** 27*27* 49*49*
对照实施例1Comparative Example 1 8080 3737 6262
对照实施例2Comparative Example 2 7676 3535 5959
#与正常组相比,*与治疗前相比P<0.05#Compared with normal group, *Compared with before treatment P<0.05
实施例5Example 5
病例一Case one
于××,女,7岁Yu ××, female, 7 years old
主诉:鼻痒、鼻塞间作1年。Main complaint: nasal itching and nasal congestion intercropped for 1 year.
现病史:患儿2年来反复鼻痒、鼻塞,晨起喷嚏、鼻痒、鼻塞,夜间咳嗽哮喘加剧,偶有。纳寐欠缺,大便1-2天1次,偏干。History of present illness: The child has repeated nasal itching and nasal congestion in the past 2 years, sneezing in the morning, nasal itching, and nasal congestion, and coughing and asthma at night intensify, occasionally. Lack of sleep soundly, stools once every 1-2 days, dry.
查体:扁桃体II°肿大,咽后壁可见淋巴滤泡增生。舌质暗红,苔白。Physical examination: the tonsils were swollen at II°, and lymphoid follicle hyperplasia was seen on the back wall of the pharynx. The tongue is dark red and the fur is white.
诊断:西医:过敏性鼻炎合并哮喘Diagnosis: Western medicine: Allergic rhinitis with asthma
处方:采用实施例1喷雾剂喷雾,每日3次,每次2mL。Prescription: Use the spray of Example 1 to spray, 3 times a day, 2 mL each time.
连续喷雾治疗4周后复诊鼻痒、鼻塞,夜间咳嗽哮喘较前明显好转,纳食好,大便调,舌质暗淡红。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.
病例二Case two
李××,男,6岁半Li ××, male, 6 and a half years old
主诉:鼻痒、打喷嚏伴流涕3月余,伴夜间哮喘咳嗽。Main complaint: itchy nose, sneezing with runny nose for more than 3 months, accompanied by night cough and asthma.
现病史:患儿近3月余出现鼻痒、打喷嚏,并伴夜间间歇性哮喘咳嗽,纳寐欠缺,大便偏干。History of present illness: The child developed nasal itching, sneezing, and nighttime intermittent asthma and coughing, lack of sleep soundness, and dry stools.
查体:肺部听诊呼吸音正常。舌质红,苔薄白。Physical examination: breath sounds normal on auscultation of the lungs. The tongue is red and the fur is thin and white.
诊断:西医:过敏性鼻炎合并哮喘。Diagnosis: Western medicine: Allergic rhinitis combined with asthma.
处方:采用实施例1喷雾剂喷雾,每日3次,每次2mL。Prescription: Use the spray of Example 1 to spray, 3 times a day, 2 mL each time.
连续喷雾治疗4周后:患儿晨起喷嚏、鼻痒、咳嗽缓解,流涕不显,纳寐可,二便调,舌质红,苔薄。After 4 weeks of continuous spray treatment: the child got up in the morning, sneezing, nasal itching, and coughing alleviated, runny nose was not obvious, sleep soundly, two bowel movements, red tongue, thin coating.

Claims (7)

  1. 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,其特征在于,它包括药物成分和辅料;A spray for the prevention and treatment of allergic asthma combined with allergic rhinitis in children and adolescents, which is characterized in that it includes pharmaceutical ingredients and auxiliary materials;
    所述的药物成分包括挥发油和中药提取物:所述的挥发油由下列原料制得:The pharmaceutical ingredients include volatile oil and Chinese medicine extracts: the volatile oil is prepared from the following raw materials:
    番荔枝种子挥发油、陈皮挥发油、沉香挥发油、紫苏挥发油、金银花挥发油、冰片;Annona seed volatile oil, tangerine peel volatile oil, agarwood volatile oil, perilla volatile oil, honeysuckle volatile oil, borneol;
    中药提取物由下列原料制得:The Chinese medicine extract is prepared from the following raw materials:
    白芥子、菊花、蔓荆子、茅岩莓茶、葛根、黄芩、密制麻黄、炒苍耳子、虎杖和丹参。White mustard seeds, chrysanthemum, vitex, Maoyan berry tea, kudzu root, scutellaria, dense ephedra, fried cocklebur, knotweed and salvia.
  2. 根据权利要求1所述的用于儿童、青少年过敏性哮喘合并过敏性鼻炎防治的喷雾剂,其特征在于,它包括药物成分和辅料;The spray for the prevention and treatment of allergic asthma combined with allergic rhinitis in children and adolescents according to claim 1, characterized in that it comprises pharmaceutical ingredients and auxiliary materials;
    所述的药物成分包括挥发油和中药提取物:所述的挥发油由下列原料制得:The pharmaceutical ingredients include volatile oil and Chinese medicine extracts: the volatile oil is prepared from the following raw materials:
    番荔枝种子挥发油3~12份、陈皮挥发油3~12份、沉香挥发油1~6份、紫苏挥发油2~8份、金银花挥发油3~12份、冰片1~3份;Annona seed volatile oil 3-12 parts, tangerine peel volatile oil 3-12 parts, agarwood volatile oil 1-6 parts, perilla volatile oil 2-8 parts, honeysuckle volatile oil 3-12 parts, borneol 1-3 parts;
    中药提取物由下列原料制得:The Chinese medicine extract is prepared from the following raw materials:
    白芥子5~15份、菊花6~18份、蔓荆子5~15份、茅岩莓茶5~15份、葛根5~15份、黄芩6~18份、密制麻黄5~15份、炒苍耳子3~9份、虎杖3~9份、丹参3~9份。5-15 parts of white mustard seeds, 6-18 parts of chrysanthemum, 5-15 parts of vitex, 5-15 parts of Maoyan berry tea, 5-15 parts of kudzu root, 6-18 parts of scutellaria, 5-15 parts of dense ephedra, Stir-fried Xanthium spp. 3-9 parts, Polygonum cuspidatum 3-9 parts, Salvia miltiorrhiza 3-9 parts.
  3. 根据权利要求2所述的用于儿童、青少年过敏性哮喘合并过敏性鼻炎防治的喷雾剂,其特征在于,The spray for the prevention and treatment of allergic asthma combined with allergic rhinitis in children and adolescents according to claim 2, characterized in that:
    它包括药物成分和辅料;It includes pharmaceutical ingredients and excipients;
    所述的药物成分包括挥发油和中药提取物:所述的挥发油由下列原料制得:The pharmaceutical ingredients include volatile oil and Chinese medicine extracts: the volatile oil is prepared from the following raw materials:
    番荔枝种子挥发油9份、陈皮挥发油6份、沉香挥发油3份、紫苏挥发油6份、金银花挥发油6份、冰片1份;9 parts of annona seed essential oil, 6 parts of tangerine peel essential oil, 3 parts of agarwood essential oil, 6 parts of perilla essential oil, 6 parts of honeysuckle essential oil, 1 part of borneol;
    中药提取物由下列原料制得:The Chinese medicine extract is prepared from the following raw materials:
    白芥子10份、菊花18份、蔓荆子10份、茅岩莓茶15份、葛根15份、黄芩12份、密制麻黄15份、炒苍耳子6份、虎杖6份、丹参6份。10 parts of white mustard seeds, 18 parts of chrysanthemum, 10 parts of vitex, 15 parts of Maoyan berry tea, 15 parts of Pueraria lobata, 12 parts of scutellaria, 15 parts of dense ephedra, 6 parts of fried cocklebur, 6 parts of Polygonum cuspidatum, 6 parts of Danshen .
  4. 根据权利要求1~3任一项所述的用于儿童、青少年过敏性哮喘合并过敏性鼻炎防治的喷雾剂,其特征在于,辅料包括乙醇、1,3-丙二醇、纯化水。The spray for the prevention and treatment of allergic asthma combined with allergic rhinitis in children and adolescents according to any one of claims 1 to 3, wherein the auxiliary materials include ethanol, 1,3-propanediol, and purified water.
  5. 根据权利要求1~3任一项所述的用于儿童、青少年过敏性哮喘合并过敏性鼻炎防治的喷雾剂,其特征在于,所述的番荔枝种子挥发油、陈皮挥发油、沉香挥发油、紫苏挥发油和金银花挥发油均采用水蒸气蒸馏法或超临界萃取法提取得到。The spray for the prevention and treatment of allergic asthma combined with allergic rhinitis in children and adolescents according to any one of claims 1 to 3, characterized in that the essential oil of annona seed, essential oil of tangerine peel, essential oil of agarwood, essential oil of perilla And honeysuckle volatile oil is obtained by steam distillation or supercritical extraction.
  6. 根据权利要求1~3任一项所述的用于儿童、青少年过敏性哮喘合并过敏性鼻炎防治的喷雾剂,其特征在于,中药提取物的制备方法包括的步骤有:The spray for the prevention and treatment of allergic asthma combined with allergic rhinitis in children and adolescents according to any one of claims 1 to 3, characterized in that the preparation method of the Chinese medicine extract comprises the following steps:
    按重量配比,取白芥子、菊花、蔓荆子、茅岩莓茶、葛根、黄芩密制麻黄、炒苍耳子、虎杖和丹参,加入药材总重量6~15倍量的水,煎煮提取1~2次,每次1~1.5小时,合并提取液,浓缩即得。According to the weight ratio, take white mustard seeds, chrysanthemums, vitex seeds, Maoyan berry tea, kudzu root, scutellaria ephedra, sauteed cocklebur, knotweed and salvia, add 6-15 times the total weight of the medicinal materials in water, and decoct Extract 1 to 2 times, 1 to 1.5 hours each time, combine the extracts and concentrate to obtain.
  7. 根据权利要求6所述的用于儿童、青少年过敏性哮喘合并过敏性鼻炎防治的喷雾剂, 其特征在于,中药提取物的制备方法包括的步骤有:The spray for the prevention and treatment of allergic asthma combined with allergic rhinitis in children and adolescents according to claim 6, characterized in that the preparation method of the Chinese medicine extract comprises the following steps:
    按重量配比,取白芥子、菊花、蔓荆子、茅岩莓茶、葛根、黄芩、密制麻黄、炒苍耳子、虎杖和丹参,第一次加入药材总重量10倍量的水,煎煮提取1.5小时,第二次加入药材总重量8倍量的水,煎煮提取1小时,合并提取液,浓缩即得。According to the weight ratio, take white mustard seeds, chrysanthemums, vitex seeds, Maoyan berry tea, kudzu root, scutellaria, dense ephedra, fried cocklebur, knotweed and salvia, and add water 10 times the total weight of the medicinal materials for the first time. Decoction and extraction for 1.5 hours, add 8 times the total weight of the medicinal material for the second time with water, decoction and extraction for 1 hour, combine the extracts, and concentrate to obtain.
PCT/CN2020/116449 2019-11-25 2020-09-21 Spraying agent for preventing and treating allergic asthma combined with allergic rhinitis in children and teenagers WO2021103777A1 (en)

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