CN117919302A - Biological composition capable of effectively relieving rhinitis symptoms and repairing nasal mucosa as well as preparation method and application thereof - Google Patents
Biological composition capable of effectively relieving rhinitis symptoms and repairing nasal mucosa as well as preparation method and application thereof Download PDFInfo
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- CN117919302A CN117919302A CN202311856083.XA CN202311856083A CN117919302A CN 117919302 A CN117919302 A CN 117919302A CN 202311856083 A CN202311856083 A CN 202311856083A CN 117919302 A CN117919302 A CN 117919302A
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- molecular weight
- sodium hyaluronate
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- nasal mucosa
- rhinitis
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- 210000002850 nasal mucosa Anatomy 0.000 title claims abstract description 53
- 239000000203 mixture Substances 0.000 title claims abstract description 52
- 206010039083 rhinitis Diseases 0.000 title claims abstract description 52
- 208000024891 symptom Diseases 0.000 title claims abstract description 39
- 238000002360 preparation method Methods 0.000 title claims abstract description 17
- 229920002385 Sodium hyaluronate Polymers 0.000 claims abstract description 52
- 229940010747 sodium hyaluronate Drugs 0.000 claims abstract description 52
- YWIVKILSMZOHHF-QJZPQSOGSA-N sodium;(2s,3s,4s,5r,6r)-6-[(2s,3r,4r,5s,6r)-3-acetamido-2-[(2s,3s,4r,5r,6r)-6-[(2r,3r,4r,5s,6r)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2- Chemical compound [Na+].CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 YWIVKILSMZOHHF-QJZPQSOGSA-N 0.000 claims abstract description 52
- 229920000057 Mannan Polymers 0.000 claims abstract description 12
- 239000001525 mentha piperita l. herb oil Substances 0.000 claims abstract description 12
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- 229920001661 Chitosan Polymers 0.000 claims abstract description 11
- 240000004808 Saccharomyces cerevisiae Species 0.000 claims abstract description 9
- LUEWUZLMQUOBSB-GFVSVBBRSA-N mannan Chemical class O[C@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@@H](O[C@@H]2[C@H](O[C@@H](O[C@H]3[C@H](O[C@@H](O)[C@@H](O)[C@H]3O)CO)[C@@H](O)[C@H]2O)CO)[C@H](O)[C@H]1O LUEWUZLMQUOBSB-GFVSVBBRSA-N 0.000 claims abstract description 6
- 239000003814 drug Substances 0.000 claims description 11
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 9
- 206010039085 Rhinitis allergic Diseases 0.000 claims description 7
- GSEJCLTVZPLZKY-UHFFFAOYSA-N Triethanolamine Chemical compound OCCN(CCO)CCO GSEJCLTVZPLZKY-UHFFFAOYSA-N 0.000 claims description 7
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- 229940124531 pharmaceutical excipient Drugs 0.000 claims description 6
- 235000010268 sodium methyl p-hydroxybenzoate Nutrition 0.000 claims description 6
- PESXGULMKCKJCC-UHFFFAOYSA-M sodium;4-methoxycarbonylphenolate Chemical compound [Na+].COC(=O)C1=CC=C([O-])C=C1 PESXGULMKCKJCC-UHFFFAOYSA-M 0.000 claims description 6
- 229940079593 drug Drugs 0.000 claims description 5
- WPYMKLBDIGXBTP-UHFFFAOYSA-N benzoic acid Chemical compound OC(=O)C1=CC=CC=C1 WPYMKLBDIGXBTP-UHFFFAOYSA-N 0.000 claims description 4
- 238000004519 manufacturing process Methods 0.000 claims description 4
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- QCDWFXQBSFUVSP-UHFFFAOYSA-N 2-phenoxyethanol Chemical compound OCCOC1=CC=CC=C1 QCDWFXQBSFUVSP-UHFFFAOYSA-N 0.000 claims description 2
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- 239000004283 Sodium sorbate Substances 0.000 claims description 2
- 235000010233 benzoic acid Nutrition 0.000 claims description 2
- 229960004365 benzoic acid Drugs 0.000 claims description 2
- BEFDCLMNVWHSGT-UHFFFAOYSA-N ethenylcyclopentane Chemical compound C=CC1CCCC1 BEFDCLMNVWHSGT-UHFFFAOYSA-N 0.000 claims description 2
- 239000000463 material Substances 0.000 claims description 2
- 229960005323 phenoxyethanol Drugs 0.000 claims description 2
- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 claims description 2
- 235000010234 sodium benzoate Nutrition 0.000 claims description 2
- 239000004299 sodium benzoate Substances 0.000 claims description 2
- 229960003885 sodium benzoate Drugs 0.000 claims description 2
- LROWVYNUWKVTCU-STWYSWDKSA-M sodium sorbate Chemical compound [Na+].C\C=C\C=C\C([O-])=O LROWVYNUWKVTCU-STWYSWDKSA-M 0.000 claims description 2
- 235000019250 sodium sorbate Nutrition 0.000 claims description 2
- 235000010199 sorbic acid Nutrition 0.000 claims description 2
- 239000004334 sorbic acid Substances 0.000 claims description 2
- 229940075582 sorbic acid Drugs 0.000 claims description 2
- DLRVVLDZNNYCBX-RTPHMHGBSA-N isomaltose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1OC[C@@H]1[C@@H](O)[C@H](O)[C@@H](O)C(O)O1 DLRVVLDZNNYCBX-RTPHMHGBSA-N 0.000 abstract description 8
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- OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 description 1
- 206010002198 Anaphylactic reaction Diseases 0.000 description 1
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- 206010061218 Inflammation Diseases 0.000 description 1
- GUBGYTABKSRVRQ-PICCSMPSSA-N Maltose Natural products O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@@H](CO)OC(O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-PICCSMPSSA-N 0.000 description 1
- 206010028116 Mucosal inflammation Diseases 0.000 description 1
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- ABBQHOQBGMUPJH-UHFFFAOYSA-M Sodium salicylate Chemical compound [Na+].OC1=CC=CC=C1C([O-])=O ABBQHOQBGMUPJH-UHFFFAOYSA-M 0.000 description 1
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- WNROFYMDJYEPJX-UHFFFAOYSA-K aluminium hydroxide Chemical compound [OH-].[OH-].[OH-].[Al+3] WNROFYMDJYEPJX-UHFFFAOYSA-K 0.000 description 1
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/534—Mentha (mint)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/702—Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/716—Glucans
- A61K31/722—Chitin, chitosan
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
- A61K31/728—Hyaluronic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/02—Nasal agents, e.g. decongestants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/08—Antiallergic agents
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Epidemiology (AREA)
- Molecular Biology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Pulmonology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Immunology (AREA)
- Otolaryngology (AREA)
- Rheumatology (AREA)
- Dermatology (AREA)
- Medicinal Preparation (AREA)
- Alternative & Traditional Medicine (AREA)
- Biotechnology (AREA)
- Botany (AREA)
- Medical Informatics (AREA)
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Pain & Pain Management (AREA)
Abstract
The invention discloses a composition capable of effectively relieving rhinitis symptoms and repairing nasal mucosa, and a preparation method and application thereof, wherein the composition comprises the following components: 3 to 5 parts of yeast mannans, 0.5 to 2 parts of sodium hyaluronate, 0.1 to 0.5 part of isomaltooligosaccharides, 0.5 to 2 parts of chitosan and 0.05 to 1 part of peppermint oil. The composition for effectively relieving rhinitis symptoms and repairing nasal mucosa provided by the invention has the advantages that sodium hyaluronate with different molecular weights is reasonably matched with mannan, chitosan, isomaltooligosaccharide and peppermint oil, so that the composition can effectively treat rhinitis and can obviously repair nasal mucosa, the product stability is good, the components are clear, the irritation to nasal mucosa and local tissues is avoided, and the safety is high.
Description
Technical Field
The invention relates to the technical field of biology, in particular to a biological composition capable of effectively relieving rhinitis symptoms and repairing nasal mucosa, and a preparation method and application thereof.
Background
Rhinitis is acute or chronic inflammation caused by damage of nasal mucosa or submucosal tissue due to virus infection, germ infection, stimulus, etc. Rhinitis causes excessive mucus, which often causes symptoms such as runny nose, nasal obstruction, etc.
At present, a lot of medicines for treating rhinitis are commonly used, mainly oral administration is adopted, but the medicines which can reach the nose are few because of the need of being delivered to nasal mucosa through systemic circulation and the like, so the medicines have the defects of slow effect and small medicine effect. There is a need to develop new products with definite ingredients, which are safer for treating rhinitis and repairing nasal mucosa.
Disclosure of Invention
The present invention aims to solve at least one of the technical problems existing in the prior art. Therefore, the invention provides a composition capable of effectively relieving rhinitis symptoms and repairing nasal mucosa, and the composition has definite components and can effectively treat rhinitis and repair nasal mucosa.
The invention also provides a preparation method of the composition.
The invention also provides application of the composition.
The invention also provides a medicine.
According to one aspect of the present invention, there is provided a composition effective for relieving rhinitis symptoms and repairing nasal mucosa, the composition comprising: 3 to 5 parts of yeast mannans, 0.5 to 2 parts of sodium hyaluronate, 0.1 to 0.5 part of isomaltooligosaccharides, 0.5 to 2 parts of chitosan and 0.05 to 1 part of peppermint oil;
The sodium hyaluronate includes low molecular weight sodium hyaluronate, medium molecular weight sodium hyaluronate and high molecular weight sodium hyaluronate;
the molecular weight of the low molecular weight sodium hyaluronate is 20kDa to 100kDa;
The molecular weight of the medium molecular weight sodium hyaluronate is 200 kDa-800 kDa;
the molecular weight of the high molecular weight sodium hyaluronate is 800kDa to 1800kDa.
In some embodiments of the present invention, the mass addition ratio of the low molecular weight sodium hyaluronate, the medium molecular weight sodium hyaluronate, and the high molecular weight sodium hyaluronate is (2 to 4): (2-5): (3-5).
According to the invention, three kinds of sodium hyaluronate with different molecular weights (low molecular weight sodium hyaluronate, medium molecular weight sodium hyaluronate and high molecular weight sodium hyaluronate) are reasonably matched and jointly entrapped, so that the comprehensive effect is remarkable, wherein the low molecular weight sodium hyaluronate can quickly permeate into cells to promote cell proliferation and repair, and meanwhile, the nasal cavity moisturizing agent has a good moisturizing effect and is beneficial to relieving symptoms such as nasal cavity dryness, itching and the like caused by rhinitis; the sodium hyaluronate with medium molecular weight has good adhesiveness, can form a layer of protective film on the surface of nasal mucosa, reduces the sensitivity to stimulus and prevents anaphylactic reaction; the high molecular weight sodium hyaluronate has large molecular weight and high viscosity, can cover the whole nasal cavity, forms a more stable protective film, and is favorable for continuously relieving rhinitis symptoms. The mannans, the chitosan, the oligomeric maltose and the peppermint oil are used together with the sodium hyaluronate with different molecular weights, so that the nasal mucosa has the effects of anti-inflammatory, antioxidation and immunoregulation, can relieve the inflammatory reaction of nasal mucosa, relieve symptoms such as nasal obstruction and nasal discharge, improve discomfort such as nasal congestion and itching caused by rhinitis, and effectively treat rhinitis and repair nasal mucosa.
In some embodiments of the invention, the composition further comprises 0.3 to 0.4 parts of a preservative and 0.03 to 0.06 parts of a pH adjustor.
In some embodiments of the invention, the preservative comprises at least one of sodium methylparaben, benzoic acid, sodium benzoate, phenoxyethanol, sorbic acid, or sodium sorbate.
In some embodiments of the invention, the pH adjuster comprises triethanolamine.
In some embodiments of the invention, the composition further comprises water.
In a second aspect of the present invention, a method for preparing the above composition is provided, comprising the steps of: mixing the above components.
In a third aspect of the invention, there is provided the use of the above composition in the manufacture of a product for the treatment of rhinitis.
In some embodiments of the invention, the rhinitis comprises allergic rhinitis.
In some embodiments of the invention, the use is in the manufacture of a product for repairing nasal mucosa.
In some embodiments of the invention, the product is a drug or medical device.
In some embodiments of the invention, the product is a pharmaceutical.
In some embodiments of the invention, the medicament further comprises a pharmaceutical excipient.
In some embodiments of the invention, the pharmaceutical excipients include at least one of diluents, excipients, fillers, binders, disintegrants, absorption enhancers, surfactants, adsorption carriers, lubricants, sweeteners, and flavoring agents.
In some embodiments of the invention, the product is in the form of one of a powder, a paste, a gel, drops, a suppository, a lozenge, a granule, a capsule, a spray, a tablet, a pill, and a solution.
In a fourth aspect of the invention, there is provided an article of manufacture comprising the composition described above for use in the treatment of rhinitis or repair of nasal mucosa.
In some embodiments of the invention, the articles include pharmaceuticals and medical devices.
In some embodiments of the invention, the medicament further comprises a pharmaceutical excipient.
In some embodiments of the invention, the pharmaceutical excipients include at least one of diluents, excipients, fillers, binders, disintegrants, absorption enhancers, surfactants, adsorption carriers, lubricants, sweeteners, and flavoring agents.
In some embodiments of the invention, the article is in the form of one of a powder, a paste, a gel, drops, a suppository, a lozenge, a granule, a capsule, a spray, a tablet, a pill, and a solution.
According to some embodiments of the invention, at least the following benefits are provided: the composition for effectively relieving rhinitis symptoms and repairing nasal mucosa provided by the invention has the advantages that sodium hyaluronate with different molecular weights is reasonably matched with mannan, chitosan, isomaltooligosaccharide and peppermint oil, so that the composition can effectively treat rhinitis and can obviously repair nasal mucosa, the product stability is good, the components are clear, the irritation to nasal mucosa and local tissues is avoided, and the safety is high.
Detailed Description
The conception and the technical effects produced by the present invention will be clearly and completely described in conjunction with the embodiments below to fully understand the objects, features and effects of the present invention. It is apparent that the described embodiments are only some embodiments of the present invention, but not all embodiments, and that other embodiments obtained by those skilled in the art without inventive effort are within the scope of the present invention based on the embodiments of the present invention.
The test methods used in the examples are conventional methods unless otherwise specified; the materials, reagents and the like used, unless otherwise specified, are those commercially available.
In the examples of the present invention, sodium hyaluronate of varying molecular weights was purchased from Guangzhou macro-control trade development Co.
Example 1
A composition capable of effectively relieving rhinitis symptoms and repairing nasal mucosa comprises the following components in percentage by weight: yeast mannan 4%, low molecular weight sodium hyaluronate 0.3% with molecular weight of 20kDa-100kDa, medium molecular weight sodium hyaluronate 0.4% with molecular weight of 200kDa-800kDa, high molecular weight sodium hyaluronate 0.3% with molecular weight of 800kDa-1800kDa, isomaltooligosaccharide 0.3%, chitosan 0.8%, peppermint oil 0.2%, sodium methylparaben 0.4% and triethanolamine 0.05%, and the balance being water.
The preparation method of the composition capable of effectively relieving rhinitis symptoms and repairing nasal mucosa comprises the following steps of:
Adding ultrapure water into yeast mannans, low molecular weight sodium hyaluronate with molecular weight of 20kDa-100kDa, medium molecular weight sodium hyaluronate with molecular weight of 200kDa-800kDa, high molecular weight sodium hyaluronate with molecular weight of 800kDa-1800kDa, isomaltooligosaccharide, chitosan, peppermint oil and sodium hydroxybenzoate, mixing uniformly, adding triethanolamine, adjusting pH to 6.0 (5.0-7.0), sterilizing, and packaging.
Example 2
A composition capable of effectively relieving rhinitis symptoms and repairing nasal mucosa comprises the following components in percentage by weight: yeast mannan 4%, low molecular weight sodium hyaluronate 0.4% with molecular weight of 20kDa-100kDa, medium molecular weight sodium hyaluronate 0.2% with molecular weight of 200kDa-800kDa, high molecular weight sodium hyaluronate 0.4% with molecular weight of 800kDa-1800kDa, isomaltooligosaccharide 0.3%, chitosan 0.8%, peppermint oil 0.2%, sodium methylparaben 0.4% and triethanolamine 0.05%, and the balance being water.
The preparation method of the composition capable of effectively relieving rhinitis symptoms and repairing nasal mucosa is described in example 1.
Example 3
A composition capable of effectively relieving rhinitis symptoms and repairing nasal mucosa comprises the following components in percentage by weight: yeast mannan 4%, low molecular weight sodium hyaluronate 0.3% with molecular weight of 20kDa-100kDa, medium molecular weight sodium hyaluronate 0.5% with molecular weight of 200kDa-800kDa, high molecular weight sodium hyaluronate 0.2% with molecular weight of 800kDa-1800kDa, isomaltooligosaccharide 0.3%, chitosan 0.8%, peppermint oil 0.2%, sodium methylparaben 0.4% and triethanolamine 0.05%, and the balance being water.
The preparation method of the composition capable of effectively relieving rhinitis symptoms and repairing nasal mucosa is described in example 1.
Example 4
A composition capable of effectively relieving rhinitis symptoms and repairing nasal mucosa comprises the following components in percentage by weight: 3% of yeast mannans, 0.3% of low molecular weight sodium hyaluronate with molecular weight of 20kDa-100kDa, 0.4% of medium molecular weight sodium hyaluronate with molecular weight of 200kDa-800kDa, 0.3% of high molecular weight sodium hyaluronate with molecular weight of 800kDa-1800kDa, 0.8% of isomaltooligosaccharide, 1.0% of chitosan, 0.4% of peppermint oil, 0.4% of sodium methylparaben and 0.05% of triethanolamine, and the balance of water.
The preparation method of the composition capable of effectively relieving rhinitis symptoms and repairing nasal mucosa is described in example 1.
Comparative example 1
A composition effective in relieving rhinitis symptoms and repairing nasal mucosa is different from example 1 in that it does not contain low molecular weight sodium hyaluronate.
The preparation method of the composition capable of effectively relieving rhinitis symptoms and repairing nasal mucosa is described in example 1.
Comparative example 2
A composition effective in relieving rhinitis symptoms and repairing nasal mucosa is different from example 1 in that it does not contain sodium hyaluronate of medium molecular weight.
The preparation method of the composition capable of effectively relieving rhinitis symptoms and repairing nasal mucosa is described in example 1.
Comparative example 3
A composition effective in relieving rhinitis symptoms and repairing nasal mucosa is different from example 1 in that it does not contain high molecular weight sodium hyaluronate.
The preparation method of the composition capable of effectively relieving rhinitis symptoms and repairing nasal mucosa is described in example 1.
Comparative example 4
A composition effective for relieving rhinitis symptoms and repairing nasal mucosa is different from example 1 in that yeast mannan is not contained.
The preparation method of the composition capable of effectively relieving rhinitis symptoms and repairing nasal mucosa is described in example 1.
Comparative example 5
A composition effective for relieving rhinitis symptoms and repairing nasal mucosa is different from example 1 in that it does not contain isomaltooligosaccharide.
The preparation method of the composition capable of effectively relieving rhinitis symptoms and repairing nasal mucosa is described in example 1.
Comparative example 6
A composition effective in relieving rhinitis symptoms and repairing nasal mucosa is different from example 1 in that no peppermint oil is contained.
The preparation method of the composition capable of effectively relieving rhinitis symptoms and repairing nasal mucosa is described in example 1.
Test case
1. Allergic rhinitis treatment experiment
Test method
(1) Test animals
The total of 120 SD rats (purchased from Beijing vitamin Torilhua laboratory animal technologies Co., ltd.) were selected, and the weight (80.+ -. 10 g) was equal to that of the male and female animals.
(2) Allergic rhinitis animal model
SD rats were sensitized by intraperitoneal injection of 25 μg of Ovalbumin (OVA), 2mg of aluminum hydroxide and 0.5mL of physiological saline on days 0, 7 and 14. SD rats were then given nasal challenge with 100 μg OVA for 7 consecutive days from day 21 to day 27. In contrast, normal SD rats were intraperitoneally injected with 0.5mL of physiological saline and nasal drops of physiological saline (at the same dose as the model) were performed until day 27.
(3) Experimental grouping
120 SD rats were randomly divided into 12 groups, respectively: a normal group, a model group, an example 1 group, an example 2 group, an example 3 group, an example 4 group, a comparative example 1 group, a comparative example 2 group, a comparative example 3 group, a comparative example 4 group, a comparative example 5 group, a comparative example 6 group; each group of 10.
On days 21 to 27 (2 to 5 hours before nasal cavity challenge with OVA), administration treatment was started, and the compositions for effectively relieving rhinitis symptoms and repairing nasal mucosa prepared in the corresponding examples and comparative examples were administered respectively in groups of 1 time per day, 40 μg each time. Normal group SD rats did not undergo any treatment; the SD rats with allergic rhinitis in the model group were administered with physiological saline 1 time a day at the same dose as in the example group or the comparative example group.
(4) Investigation index
Allergic rhinitis is a specific disease and is mainly characterized by nasal obstruction, nasal mucus wiping, sneezing, nasal pruritus and other symptoms. Thus, after the last OVA nasal challenge, the number of sneezes in SD rats was recorded for 30min and 60min, and the number of nasal scratches for 15min.
In addition, 0.7mL of blood was collected from each SD rat after the end of the treatment, and total IgE levels and OVA-specific IgE levels were determined using an ELISA kit according to the manufacturer's instructions.
1) Sneeze times
TABLE 1
| Group of | 30min | 60min |
| Example 1 | 3.2±0.8 | 5.6±0.4 |
| Example 2 | 5.4±1.7 | 8.1±0.9 |
| Example 3 | 3.7±1.2 | 7.1±1.2 |
| Example 4 | 6.4±1.6 | 10.6±2.5 |
| Comparative example 1 | 12.5±2.6 | 19.4±3.2 |
| Comparative example 2 | 15.7±3.1 | 22.5±1.7 |
| Comparative example 3 | 11.6±2.7 | 21.7±4.2 |
| Comparative example 4 | 21.4±3.5 | 32.2±3.3 |
| Comparative example 5 | 14.3±2.4 | 18.4±2.6 |
| Comparative example 6 | 10.2±0.6 | 16.7±2.3 |
| Model group | 65.7±6.4 | 78.6±5.1 |
| Normal group | 12.8±1.9 | 16.5±1.6 |
The results are shown in Table 1, from which it can be seen that the number of sneezes was significantly lower in the SD rats of the examples and comparative examples than in the model group.
2) Number of times of nose scratching
Table 2 number of nasal scratching times in SD rats of each group
The results are shown in Table 2, and the SD rats in the example group and the comparative example group were given a significantly lower number of nasal scratches than the model group; particularly, the nasal conditions of rats in the example group are significantly improved, and the nasal frequency of the rats is equivalent to that of rats in the normal group.
3) Serum total IgE levels and OVA-specific IgE levels in rats before and after treatment
TABLE 3 serum total IgE levels and OVA-specific IgE levels in rats after treatment of each group
| Group of | Total lgE level (ng/mL) | OVA specific lgE level (ng/mL) |
| Example 1 | 478.2±57.6 | 0.9±0.3 |
| Example 2 | 524.4±36.4 | 1.5±0.4 |
| Example 3 | 516.7±39.7 | 1.2±0.1 |
| Example 4 | 545.2±63.4 | 1.6±0.2 |
| Comparative example 1 | 1089.7±87.9 | 9.2±2.1 |
| Comparative example 2 | 1019.6±88.54 | 8.7±3.2 |
| Comparative example 3 | 977.1±64.3 | 8.4±2.5 |
| Comparative example 4 | 1207.4±106.3 | 13.7±2.8 |
| Comparative example 5 | 787.3±76.5 | 6.5±1.7 |
| Comparative example 6 | 723.5±69.4 | 5.1±0.9 |
| Model group | 2247.2±124.3 | 20.7±1.5 |
| Normal group | 586.7±26.2 | 1.8±0.4 |
The results are shown in table 3, with SD rats in the example and comparative groups, the total IgE levels and OVA-specific IgE levels in the serum were significantly lower than in the model group after administration; and the serum of the rats in the example group has obviously reduced total IgE level and OVA specific IgE level compared with the rats in the comparative example group, which is equivalent to the rats in the normal group.
4) Mucous membrane repair experiment
The nasal mucosa histology observation on normal animals almost has no nasal mucosa Eosinophil (EOS) infiltration, and after repeated OVA antigen attack, the model group has nasal mucosa ulcer, turbinate mucosa swelling, eosinophil infiltration, gland hyperplasia and congestion edema, and especially EOS infiltration is obviously increased. After 7d of continuous administration, the above pathological features of the treatment group were significantly improved and EOS infiltration was significantly reduced.
TABLE 4 Table 4
| Group of | Nasal mucosa eosinophil count (number) |
| Example 1 | 2.3±0.5 |
| Example 2 | 2.9±0.4 |
| Example 3 | 2.6±0.2 |
| Example 4 | 3.1±0.8 |
| Comparative example 1 | 5.9±1.1 |
| Comparative example 2 | 5.7±0.9 |
| Comparative example 3 | 5.4±1.3 |
| Comparative example 4 | 6.2±0.4 |
| Comparative example 5 | 4.1±1.3 |
| Comparative example 6 | 3.9±0.8 |
| Model group | 8.3±0.9 |
| Normal group | 1.3±0.4 |
The results are shown in Table 4, and it can be seen from the tables that the EOS counts were reduced after administration of the present invention and the comparative examples, compared to the model group, indicating that administration of the composition of the present invention was effective in improving nasal mucositis infiltration in allergic rhinitis mice.
2. Clinical validation experiment
40 Rhinitis patients with nasal mucosa injury in the age of 30-60 years are randomly selected, and are all informed consent patients, and all the diagnosis contents of all the patients meet the rhinitis diagnosis standard currently issued by the medical society in China.
Random average grouping: the trial experience was performed with the same amount of example 1 and commercially available rhinitis gel, respectively, for 20 patients per group, 2 times per day, and the test results were observed after 7 days.
And (3) curing: the clinical symptoms of the patient disappear, and the nasal mucosa is free from edema and secretion through nasal examination;
The method is effective: the clinical symptoms of the patients are improved, and the mucous membrane edema and secretion in the nasal cavity are improved through nasal examination;
Invalidation: the clinical symptoms and signs of the patients are unchanged.
Total clinical effective rate= (cure+effective)/total number x 100%.
TABLE 5
| Group of | Number of examples | Healing | Effective and effective | Total effective rate |
| Example 1 | 20 | 18 | 19 | 95％ |
| Commercially available rhinitis gel | 20 | 14 | 18 | 90％ |
The results are shown in Table 5, and it can be seen from the table that the composition for effectively relieving rhinitis symptoms and repairing nasal mucosa prepared in the embodiment 1 of the invention can effectively relieve rhinitis symptoms and has a certain repairing effect on nasal mucosa.
The above-described embodiments of the present invention have been described in detail, but the present invention is not limited to the above-described embodiments, and various changes can be made within the knowledge of those skilled in the art without departing from the spirit of the present invention. Furthermore, embodiments of the invention and features of the embodiments may be combined with each other without conflict.
Claims (10)
1. A composition effective for relieving symptoms of rhinitis and repairing nasal mucosa, said composition comprising: 3 to 5 parts of yeast mannans, 0.5 to 2 parts of sodium hyaluronate, 0.1 to 0.5 part of isomaltooligosaccharides, 0.5 to 2 parts of chitosan and 0.05 to 1 part of peppermint oil;
The sodium hyaluronate includes low molecular weight sodium hyaluronate, medium molecular weight sodium hyaluronate and high molecular weight sodium hyaluronate;
the molecular weight of the low molecular weight sodium hyaluronate is 20kDa to 100kDa;
The molecular weight of the medium molecular weight sodium hyaluronate is 200 kDa-800 kDa;
the molecular weight of the high molecular weight sodium hyaluronate is 800kDa to 1800kDa.
2. The composition according to claim 1, wherein the mass addition ratio of the low molecular weight sodium hyaluronate, the medium molecular weight sodium hyaluronate and the high molecular weight sodium hyaluronate is (2 to 4): (2-5): (3-5).
3. The composition of claim 1, wherein the composition further comprises 0.3 to 0.4 parts of a preservative and 0.03 to 0.06 parts of a pH adjuster; preferably, the preservative comprises at least one of sodium methylparaben, benzoic acid, sodium benzoate, phenoxyethanol, sorbic acid, or sodium sorbate; preferably, the pH adjuster comprises triethanolamine.
4. A process for the preparation of a composition as claimed in any one of claims 1 to 3, comprising the steps of: mixing the above materials.
5. Use of a composition according to any one of claims 1 to 3 in the manufacture of a product for the treatment of rhinitis.
6. The use according to claim 5, wherein the rhinitis comprises allergic rhinitis.
7. Use of a composition according to any one of claims 1-3 for the preparation of a product for repairing nasal mucosa.
8. An article comprising the composition of any one of claims 1-3.
9. The article of claim 8, wherein the article is a drug or medical device; preferably, the medicament further comprises a pharmaceutical excipient; more preferably, the pharmaceutical excipients include at least one of diluents, excipients, fillers, binders, disintegrants, absorption enhancers, surfactants, adsorption carriers, lubricants, sweeteners, and flavoring agents.
10. The article of claim 9, wherein the article is in the form of one of a powder, a paste, a gel, a drop, a suppository, a lozenge, a granule, a capsule, a spray, a tablet, a pill, and a solution.
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Citations (4)
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|---|---|---|---|---|
| JP2004224772A (en) * | 2003-01-27 | 2004-08-12 | Asahi Breweries Ltd | Allergic diathesis improver containing mannan of saccharomyces yeast as effective component |
| CN106727277A (en) * | 2015-11-22 | 2017-05-31 | 中国人民解放军第三军医大学 | A kind of mentholated nasal cavity in-situ gel spray and preparation method thereof |
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| CN115998761A (en) * | 2022-12-30 | 2023-04-25 | 湖南天根乐微君科技有限公司 | Antiallergic rhinitis composition and preparation method and application thereof |
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2023
- 2023-12-29 CN CN202311856083.XA patent/CN117919302A/en active Pending
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| JP2004224772A (en) * | 2003-01-27 | 2004-08-12 | Asahi Breweries Ltd | Allergic diathesis improver containing mannan of saccharomyces yeast as effective component |
| CN106727277A (en) * | 2015-11-22 | 2017-05-31 | 中国人民解放军第三军医大学 | A kind of mentholated nasal cavity in-situ gel spray and preparation method thereof |
| CN111135141A (en) * | 2020-01-20 | 2020-05-12 | 蓝佳堂生物医药（福建）有限公司 | Preparation method of composite hydrogel for nasal cavity |
| CN115998761A (en) * | 2022-12-30 | 2023-04-25 | 湖南天根乐微君科技有限公司 | Antiallergic rhinitis composition and preparation method and application thereof |
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