CN117462493A - Nasal cavity antiallergic gel spray and preparation method thereof - Google Patents
Nasal cavity antiallergic gel spray and preparation method thereof Download PDFInfo
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- CN117462493A CN117462493A CN202210869476.3A CN202210869476A CN117462493A CN 117462493 A CN117462493 A CN 117462493A CN 202210869476 A CN202210869476 A CN 202210869476A CN 117462493 A CN117462493 A CN 117462493A
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- 239000007921 spray Substances 0.000 title claims abstract description 81
- 210000003928 nasal cavity Anatomy 0.000 title claims abstract description 48
- 230000003266 anti-allergic effect Effects 0.000 title claims abstract description 41
- 238000002360 preparation method Methods 0.000 title abstract description 16
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims abstract description 39
- 229920002134 Carboxymethyl cellulose Polymers 0.000 claims abstract description 15
- 239000001768 carboxy methyl cellulose Substances 0.000 claims abstract description 15
- 235000010948 carboxy methyl cellulose Nutrition 0.000 claims abstract description 15
- 239000008112 carboxymethyl-cellulose Substances 0.000 claims abstract description 15
- 239000000230 xanthan gum Substances 0.000 claims abstract description 14
- 229920001285 xanthan gum Polymers 0.000 claims abstract description 14
- 229940082509 xanthan gum Drugs 0.000 claims abstract description 14
- 235000010493 xanthan gum Nutrition 0.000 claims abstract description 14
- 239000008213 purified water Substances 0.000 claims abstract description 13
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 13
- IPGANOYOHAODGA-UHFFFAOYSA-N dilithium;dimagnesium;dioxido(oxo)silane Chemical compound [Li+].[Li+].[Mg+2].[Mg+2].[O-][Si]([O-])=O.[O-][Si]([O-])=O.[O-][Si]([O-])=O IPGANOYOHAODGA-UHFFFAOYSA-N 0.000 claims abstract description 12
- 239000000796 flavoring agent Substances 0.000 claims abstract description 9
- 235000013355 food flavoring agent Nutrition 0.000 claims abstract description 9
- LXCFILQKKLGQFO-UHFFFAOYSA-N methylparaben Chemical compound COC(=O)C1=CC=C(O)C=C1 LXCFILQKKLGQFO-UHFFFAOYSA-N 0.000 claims description 34
- QELSKZZBTMNZEB-UHFFFAOYSA-N propylparaben Chemical compound CCCOC(=O)C1=CC=C(O)C=C1 QELSKZZBTMNZEB-UHFFFAOYSA-N 0.000 claims description 26
- 238000003756 stirring Methods 0.000 claims description 19
- 235000010270 methyl p-hydroxybenzoate Nutrition 0.000 claims description 17
- 239000004292 methyl p-hydroxybenzoate Substances 0.000 claims description 16
- 229960002216 methylparaben Drugs 0.000 claims description 16
- 229960003415 propylparaben Drugs 0.000 claims description 14
- 235000010232 propyl p-hydroxybenzoate Nutrition 0.000 claims description 13
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 12
- 239000004405 propyl p-hydroxybenzoate Substances 0.000 claims description 12
- 235000016257 Mentha pulegium Nutrition 0.000 claims description 11
- 235000004357 Mentha x piperita Nutrition 0.000 claims description 11
- 235000001050 hortel pimenta Nutrition 0.000 claims description 11
- 239000000341 volatile oil Substances 0.000 claims description 11
- 239000002245 particle Substances 0.000 claims description 9
- 238000005303 weighing Methods 0.000 claims description 8
- 229910000403 monosodium phosphate Inorganic materials 0.000 claims description 6
- 235000019799 monosodium phosphate Nutrition 0.000 claims description 6
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical group [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 claims description 6
- 244000246386 Mentha pulegium Species 0.000 claims description 5
- 238000000034 method Methods 0.000 claims description 5
- 238000004090 dissolution Methods 0.000 claims description 4
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 claims description 4
- 235000015165 citric acid Nutrition 0.000 claims description 2
- 239000004310 lactic acid Substances 0.000 claims description 2
- 235000014655 lactic acid Nutrition 0.000 claims description 2
- 239000003002 pH adjusting agent Substances 0.000 claims 1
- 210000004400 mucous membrane Anatomy 0.000 abstract description 4
- 230000004888 barrier function Effects 0.000 abstract description 2
- 230000036760 body temperature Effects 0.000 abstract description 2
- 238000005516 engineering process Methods 0.000 abstract description 2
- 108010025899 gelatin film Proteins 0.000 abstract description 2
- 230000005484 gravity Effects 0.000 abstract description 2
- QPJVMBTYPHYUOC-UHFFFAOYSA-N methyl benzoate Chemical compound COC(=O)C1=CC=CC=C1 QPJVMBTYPHYUOC-UHFFFAOYSA-N 0.000 abstract 2
- UDEWPOVQBGFNGE-UHFFFAOYSA-N benzoic acid n-propyl ester Natural products CCCOC(=O)C1=CC=CC=C1 UDEWPOVQBGFNGE-UHFFFAOYSA-N 0.000 abstract 1
- 229940095102 methyl benzoate Drugs 0.000 abstract 1
- OLXYLDUSSBULGU-UHFFFAOYSA-N methyl pyridine-4-carboxylate Chemical compound COC(=O)C1=CC=NC=C1 OLXYLDUSSBULGU-UHFFFAOYSA-N 0.000 abstract 1
- 230000000694 effects Effects 0.000 description 29
- 239000000243 solution Substances 0.000 description 25
- 238000005507 spraying Methods 0.000 description 16
- 210000003625 skull Anatomy 0.000 description 9
- 210000001989 nasopharynx Anatomy 0.000 description 7
- 210000001944 turbinate Anatomy 0.000 description 7
- 241001479543 Mentha x piperita Species 0.000 description 6
- 230000001580 bacterial effect Effects 0.000 description 4
- 238000002474 experimental method Methods 0.000 description 4
- 210000002850 nasal mucosa Anatomy 0.000 description 4
- NIXOWILDQLNWCW-UHFFFAOYSA-N Acrylic acid Chemical compound OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 description 3
- 229920002125 Sokalan® Polymers 0.000 description 3
- GSEJCLTVZPLZKY-UHFFFAOYSA-N Triethanolamine Chemical class OCCN(CCO)CCO GSEJCLTVZPLZKY-UHFFFAOYSA-N 0.000 description 3
- 239000013566 allergen Substances 0.000 description 3
- 229960001631 carbomer Drugs 0.000 description 3
- 230000000052 comparative effect Effects 0.000 description 3
- 239000000428 dust Substances 0.000 description 3
- 239000003755 preservative agent Substances 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- 206010039085 Rhinitis allergic Diseases 0.000 description 2
- 201000009961 allergic asthma Diseases 0.000 description 2
- 201000010105 allergic rhinitis Diseases 0.000 description 2
- 208000006673 asthma Diseases 0.000 description 2
- 239000010410 layer Substances 0.000 description 2
- 244000000010 microbial pathogen Species 0.000 description 2
- 230000002906 microbiologic effect Effects 0.000 description 2
- 230000002335 preservative effect Effects 0.000 description 2
- 239000000725 suspension Substances 0.000 description 2
- 238000005406 washing Methods 0.000 description 2
- 241000238876 Acari Species 0.000 description 1
- 241000228245 Aspergillus niger Species 0.000 description 1
- 241000222122 Candida albicans Species 0.000 description 1
- 241000196324 Embryophyta Species 0.000 description 1
- 241000588724 Escherichia coli Species 0.000 description 1
- 241000589517 Pseudomonas aeruginosa Species 0.000 description 1
- 241000191967 Staphylococcus aureus Species 0.000 description 1
- 241000700605 Viruses Species 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 230000002421 anti-septic effect Effects 0.000 description 1
- 230000000903 blocking effect Effects 0.000 description 1
- 229940095731 candida albicans Drugs 0.000 description 1
- 238000005260 corrosion Methods 0.000 description 1
- 230000007797 corrosion Effects 0.000 description 1
- 239000002537 cosmetic Substances 0.000 description 1
- 238000012258 culturing Methods 0.000 description 1
- 238000010790 dilution Methods 0.000 description 1
- 239000012895 dilution Substances 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 230000001717 pathogenic effect Effects 0.000 description 1
- 239000002504 physiological saline solution Substances 0.000 description 1
- 239000011241 protective layer Substances 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 230000029058 respiratory gaseous exchange Effects 0.000 description 1
- 230000008786 sensory perception of smell Effects 0.000 description 1
- 239000012192 staining solution Substances 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/10—Dispersions; Emulsions
- A61K9/12—Aerosols; Foams
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0043—Nose
-
- 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
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/08—Antiallergic agents
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Otolaryngology (AREA)
- Inorganic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pulmonology (AREA)
- Dispersion Chemistry (AREA)
- Organic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Immunology (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses nasal cavity antiallergic gel spray and a preparation method thereof, and belongs to the technical field of medical science and technology. The invention discloses nasal cavity antiallergic gel spray which consists of lithium magnesium silicate, xanthan gum, carboxymethyl cellulose, a pH regulator, propylene glycol, methyl benzoate, propyl benzoate, a flavoring agent and purified water. The gel prepared by the invention can form a stable gel film after being sprayed on a using part, and the phenomenon that gel becomes thin or flows out due to the action of physiological body temperature or gravity can not occur; after being sprayed to the nasal cavity, the nasal cavity is sprayed to form a film which is firmly attached to the nasal cavity mucous membrane to provide continuous barrier protection for the nasal cavity mucous membrane; and carboxymethyl cellulose can increase the residence time of the gel in the nasal cavity.
Description
Technical Field
The invention relates to the technical field of medical science and technology, in particular to a nasal cavity antiallergic gel spray and a preparation method thereof.
Background
As is well known, the nasal cavity is the main channel of respiration and plays the physiological roles of olfaction, removing foreign pathogenic microorganisms and dust, heating and humidifying. And because the natural environment is filled with pathogenic microorganisms such as dust mites, bacterial viruses and the like and pathogenic factors such as haze, plant and chemical dust and the like, patients suffering from allergic rhinitis and asthma are increased, and the daily work and life of people are also seriously influenced. In daily care of patients with allergic rhinitis or asthma, a method for washing nasal cavity by using physiological saline is currently available, and although the nasal cavity washing can remove the allergen in the nasal cavity to a certain extent, the washed nasal mucosa is still exposed in the air containing the allergen; based on this, it is particularly important to prepare a product that can form an insulating protective layer on the nasal mucosa.
Therefore, providing a nasal cavity antiallergic gel spray and a preparation method thereof is a problem to be solved by those skilled in the art.
Disclosure of Invention
In view of the above, the invention provides a nasal cavity antiallergic gel spray and a preparation method thereof, and the obtained nasal cavity antiallergic gel spray can form a layer of gel on nasal mucosa, and can realize the purpose of isolating allergens by providing a layer of invisible mask on the nasal mucosa.
In order to achieve the above purpose, the present invention adopts the following technical scheme:
the nasal cavity antiallergic gel spray comprises 0.3-2% of magnesium lithium silicate, 0.05-0.2% of xanthan gum, 0.01-0.1% of carboxymethyl cellulose, 0.01-0.1% of pH regulator, 1-3% of propylene glycol, 0.05-0.2% of methyl hydroxybenzoate, 0.01-0.03% of propyl hydroxybenzoate, 0.001-0.008% of flavoring agent and the balance of purified water; the pH value of the nasal cavity antiallergic gel spray is 6.0-8.0, so that the pH value of the product is kept in the pH value range which is the optimum of the nasal cavity of a human body. Methyl paraben and propyl paraben are used as preservatives. The percentage of each substance is the mass-to-volume ratio (g/L).
Further, the pH regulator is sodium dihydrogen phosphate, citric acid or lactic acid.
Further, the flavoring agent is peppermint essential oil.
Further, the preparation method of the nasal cavity antiallergic gel spray comprises the following specific steps:
(1) Weighing methylparaben and propylparaben, adding the methylparaben into propylene glycol, and stirring for dissolution to obtain a solution A;
(2) Dispersing lithium magnesium silicate into purified water, and stirring until the solution is transparent to obtain a solution B;
(3) Adding carboxymethyl cellulose into the solution B obtained in the step (2), and stirring until no particles exist, so as to obtain a solution C;
(4) Adding the solution A dissolved in the step (1) into the solution C obtained in the step (3), and uniformly stirring to obtain a solution D;
(5) And (3) weighing xanthan gum, a pH regulator and a flavoring agent, adding the xanthan gum, the pH regulator and the flavoring agent into the solution D obtained in the step (4), and uniformly stirring to obtain the nasal cavity antiallergic gel spray.
Compared with the prior art, the invention discloses the nasal cavity antiallergic gel spray and the preparation method thereof, and the prepared gel spray can form a stable gel film after being sprayed on a using part, and the phenomenon that gel becomes thin or flows out due to the action of physiological body temperature or gravity is avoided; after being sprayed to the nasal cavity, the nasal cavity is sprayed to form a film which is firmly attached to the nasal cavity mucous membrane to provide continuous barrier protection for the nasal cavity mucous membrane; and carboxymethyl cellulose can increase the residence time of the gel in the nasal cavity.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are required to be used in the embodiments or the description of the prior art will be briefly described below, and it is obvious that the drawings in the following description are only embodiments of the present invention, and that other drawings can be obtained according to the provided drawings without inventive effort for a person skilled in the art.
FIG. 1 is a graph showing the effect of spraying gel prepared in example 1 of the present invention;
FIG. 2 is a graph showing the effect of spraying gel prepared in example 2 of the present invention;
FIG. 3 is a graph showing the effect of spraying gel prepared in example 3 of the present invention;
FIG. 4 is a graph showing the effect of spraying gel prepared in example 4 of the present invention;
FIG. 5 is a graph showing the effect of spraying gel prepared in example 5 of the present invention;
FIG. 6 is a graph showing the effect of spraying gel prepared in example 6 of the present invention;
FIG. 7 is a graph showing the effect of spraying gel prepared in example 7 of the present invention;
FIG. 8 is a graph showing the effect of spraying gel prepared in comparative examples of the present invention.
Detailed Description
The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
The raw materials such as lithium magnesium silicate, xanthan gum and the like used in the invention are all commercial products unless explicitly stated.
The percentage of each substance is the mass-to-volume ratio (g/L).
The gel spray prepared by the invention is colorless and transparent, and red staining solution is added in order to clearly see the attached state on the skull model.
Example 1
A nasal cavity antiallergic gel spray, which is prepared according to the following table:
lithium magnesium silicate | 0.8% |
Xanthan gum | 0.15% |
Carboxymethyl cellulose | 0.05% |
Sodium dihydrogen phosphate | 0.05% |
Propylene glycol | 3% |
Methyl paraben | 0.2% |
Propyl paraben | 0.03% |
Peppermint essential oil | 0.004% |
Purified water | To 1000mL |
The preparation method of the nasal cavity antiallergic gel spray comprises the following specific steps:
(1) Weighing methylparaben and propylparaben, adding the methylparaben into propylene glycol, and stirring for dissolution to obtain a solution A;
(2) Dispersing lithium magnesium silicate into purified water, and stirring until the solution is transparent to obtain a solution B;
(3) Adding carboxymethyl cellulose into the solution B obtained in the step (2), and stirring until no particles exist, so as to obtain a solution C;
(4) Adding the solution A dissolved in the step (1) into the solution C obtained in the step (3), and uniformly stirring to obtain a solution D;
(5) And (3) weighing xanthan gum, a pH regulator (sodium dihydrogen phosphate) and a flavoring agent (peppermint essential oil), adding into the solution D obtained in the step (4), and uniformly stirring to obtain nasal cavity antiallergic gel spray, wherein the pH is 7.45.
Spray effect experiment:
the gel prepared in example 1 was filled into spray bottles and the spray effect was simulated on a skull model, the results are shown in figure 1.
The spraying effect is as follows:
1) The spray particles are fine and uniform, and gel can be stably attached after being sprayed on a model, and cannot flow out from a nasopharynx tube or nostril;
2) The position can be covered: the nasal vestibule, nasal cavity, nasal turbinates and anterior nasal meatus half.
Example 2
A nasal cavity antiallergic gel spray, which is prepared according to the following table:
lithium magnesium silicate | 1% |
Xanthan gum | 0.2% |
Carboxymethyl cellulose | 0.05% |
Sodium dihydrogen phosphate | 0.05% |
Propylene glycol | 2.5% |
Methyl paraben | 0.2% |
Propyl paraben | 0.03% |
Peppermint essential oil | 0.004% |
Purified water | To 1000mL |
The preparation method of the nasal antiallergic gel spray is the same as that of example 1; the pH of the nasal antiallergic gel spray was 7.36.
Spray effect experiment:
the gel prepared in example 2 was filled into spray bottles and the spray effect was simulated on a skull model, the results are shown in figure 2.
The spraying effect is as follows:
1) The spray particles are fine and uniform, and gel can be stably attached after being sprayed on a model, and cannot flow out from a nasopharynx tube or nostril;
2) The position can be covered: the nasal vestibule, nasal cavity, nasal turbinates and anterior nasal meatus half.
Example 3
A nasal cavity antiallergic gel spray, which is prepared according to the following table:
lithium magnesium silicate | 1.125% |
Xanthan gum | 0.05% |
Carboxymethyl cellulose | 0.05% |
Citric acid | 0.05% |
Propylene glycol | 2% |
Methyl paraben | 0.2% |
Propyl paraben | 0.03% |
Peppermint essential oil | 0.004% |
Purified water | To 1000mL |
The preparation method of the nasal antiallergic gel spray is the same as that of example 1; the nasal antiallergic gel spray had a pH of 7.42.
Spray effect experiment:
the gel prepared in example 3 was filled into spray bottles and the spray effect was simulated on a skull model, the results are shown in figure 3.
The spraying effect is as follows:
1) The spray particles are fine and uniform, and gel can be stably attached after being sprayed on a model, and cannot flow out from a nasopharynx tube or nostril;
2) The position can be covered: the nasal vestibule, nasal cavity, nasal turbinates and anterior nasal meatus half.
Example 4
A nasal cavity antiallergic gel spray, which is prepared according to the following table:
the preparation method of the nasal antiallergic gel spray is the same as that of example 1; the pH of the nasal antiallergic gel spray was 7.95.
Spray effect experiment:
the gel prepared in example 4 was filled into spray bottles and the spray effect was simulated on a skull model, the results are shown in fig. 4.
The spraying effect is as follows:
1) The spray particles are fine and uniform, and gel can be stably attached after being sprayed on a model, and cannot flow out from a nasopharynx tube or nostril;
2) The position can be covered: the nasal vestibule, nasal cavity, nasal turbinates and anterior nasal meatus half.
Corrosion challenge test
1) Test strain: escherichia coli (CMCC), pseudomonas aeruginosa, staphylococcus aureus, candida albicans, aspergillus niger;
2) The test sample was the gel spray sample prepared in example 4;
3) Bacterial suspensions are prepared and counted according to the steps in T/SHRH 017-2019 'cosmetic antiseptic challenge test', then samples are infected according to the method of 7.3 challenge test, and after 7d, 14d, 21d and 28d are respectively cultured at 25 ℃, the bacterial suspensions are counted by adopting a dilution plate method. And calculates a log reduction value R x 。
R x =lgN 0 -lgN x The method comprises the steps of carrying out a first treatment on the surface of the Wherein N is 0 : initial bacterial concentration, N x : culturing X (7 d, 14d, 21d, 28 d)) Post-bacterial concentration.
4) The results are shown in the following Table
The results in the above table show that the preservative system (methyl and propyl parabens) used in the gel spray prepared according to the invention meets the microbiological limitations of the product.
Example 5
A nasal cavity antiallergic gel spray, which is prepared according to the following table:
lithium magnesium silicate | 2% |
Xanthan gum | 0.1% |
Carboxymethyl cellulose | 0.01% |
Citric acid | 0.1% |
Propylene glycol | 1% |
Methyl paraben | 0.1% |
Propyl paraben | 0.015% |
Peppermint essential oil | 0.008% |
Purified water | To 1000mL |
The preparation method of the nasal antiallergic gel spray is the same as that of example 1; the nasal antiallergic gel spray had a pH of 7.27.
The gel prepared in example 5 was filled into spray bottles and the spray effect was simulated on a skull model, the results are shown in figure 5.
The spraying effect is as follows:
1) The spray can be formed, but the spray wide angle is slightly worse than that of the embodiment 4, and gel can be stably attached after being sprayed on a model and cannot flow out from a nasopharynx tube or nostril;
2) The position can be covered: the nasal vestibule, nasal cavity, nasal turbinates and anterior nasal meatus half;
example 6
A nasal cavity antiallergic gel spray, which is prepared according to the following table:
the preparation method of the nasal antiallergic gel spray is the same as that of example 1; the nasal antiallergic gel spray had a pH of 7.32.
The gel prepared in example 6 was filled into spray bottles and the spray effect was simulated on a skull model, the results are shown in fig. 6.
The spraying effect is as follows:
1) The spray drops are tiny and uniform, gel can be attached after the spray drops are sprayed to a model, and the spray drops slightly flow;
2) Can cover the position, nasal vestibule, nasal cavity, turbinate and anterior half of nasal meatus.
Example 7
A nasal cavity antiallergic gel spray, which is prepared according to the following table:
lithium magnesium silicate | 0.85% |
Xanthan gum | 0.15% |
Carboxymethyl cellulose | 0.05% |
Sodium dihydrogen phosphate | 0.05% |
Propylene glycol | 1.5% |
Methyl paraben | 0.1% |
Propyl paraben | 0.015% |
Peppermint essential oil | 0.004% |
Purified water | To 1000mL |
The preparation method of the nasal antiallergic gel spray is the same as that of example 1; the nasal antiallergic gel spray had a pH of 7.25.
The gel prepared in example 7 was filled into spray bottles and the spray effect was simulated on a skull model, the results are shown in fig. 7.
The spraying effect is as follows:
1) The spray particles are fine and uniform, and gel can be stably attached after being sprayed on a model, and cannot flow out from a nasopharynx tube or nostril;
2) The position can be covered: the nasal vestibule, nasal cavity, nasal turbinates and anterior nasal meatus half.
The preservative systems (methyl paraben and propyl paraben) used in the gel sprays of examples 1-3 and 5-7 of the present invention all meet the microbiological limitations of the product.
Comparative example
A gel spray, which is prepared according to the following table:
carbomer (carbomer) | 0.15% |
Carboxymethyl cellulose | 0.1% |
Propylene glycol | 1.5% |
Methyl paraben | 0.1% |
Propyl paraben | 0.015% |
Triethanolamine salt | 0.16% |
Peppermint essential oil | 0.004% |
Purified water | To 1000mL |
The preparation method of the gel spray comprises the following specific steps:
(1) Weighing methylparaben and propylparaben, adding the methylparaben into propylene glycol, and stirring for dissolution to obtain a solution A;
(2) Adding carbomer and carboxymethyl cellulose into purified water, and stirring until no particles exist, so as to obtain a solution B;
(3) Adding the solution A dissolved in the step (1) into the solution B obtained in the step (2), and uniformly stirring to obtain a solution C;
(4) And (3) weighing triethanolamine and peppermint essential oil, adding the triethanolamine and the peppermint essential oil into the solution C obtained in the step (3), and uniformly stirring.
The gel prepared in the comparative example was filled in a spray bottle, and the spray effect was simulated on a skull model, and the result is shown in fig. 8.
The spraying effect is as follows:
can form spray, but has poor spray effect, small spray wide angle, no adhesive force of gel after being sprayed on a model, and no blocking effect after flowing out from a nasopharynx tube or nostril.
The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.
Claims (4)
1. The nasal cavity antiallergic gel spray is characterized in that each 1L of nasal cavity antiallergic gel spray contains 0.3-2% of magnesium lithium silicate, 0.05-0.2% of xanthan gum, 0.01-0.1% of carboxymethyl cellulose, 0.01-0.1% of pH regulator, 1-3% of propylene glycol, 0.05-0.2% of methyl hydroxybenzoate, 0.01-0.03% of propyl hydroxybenzoate, 0.001-0.008% of flavoring agent and the balance of purified water; the pH of the nasal cavity antiallergic gel spray is 6.0-8.0.
2. A nasal antiallergic gel spray according to claim 1, wherein the pH adjuster is sodium dihydrogen phosphate, citric acid or lactic acid.
3. A nasal antiallergic gel spray according to claim 1, wherein the flavouring is peppermint essential oil.
4. A method for preparing a nasal antiallergic gel spray according to any one of claims 1-3, characterized by the specific steps of:
(1) Weighing methylparaben and propylparaben, adding the methylparaben into propylene glycol, and stirring for dissolution to obtain a solution A;
(2) Dispersing lithium magnesium silicate into purified water, and stirring until the solution is transparent to obtain a solution B;
(3) Adding carboxymethyl cellulose into the solution B obtained in the step (2), and stirring until no particles exist, so as to obtain a solution C;
(4) Adding the solution A dissolved in the step (1) into the solution C obtained in the step (3), and uniformly stirring to obtain a solution D;
(5) And (3) weighing xanthan gum, a pH regulator and a flavoring agent, adding the xanthan gum, the pH regulator and the flavoring agent into the solution D obtained in the step (4), and uniformly stirring to obtain the nasal cavity antiallergic gel spray.
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