CN117462493A - Nasal cavity antiallergic gel spray and preparation method thereof - Google Patents

Nasal cavity antiallergic gel spray and preparation method thereof Download PDF

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Publication number
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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nasal cavity
gel
spray
solution
nasal
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梁潇
刘巍巍
李建强
冯宏美
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Bi Nuo Tianjin Medical Equipment Co ltd
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Bi Nuo Tianjin Medical Equipment Co ltd
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Priority to CN202210869476.3A priority Critical patent/CN117462493A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/12Aerosols; Foams
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/06Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • 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
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/08Antiallergic 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

Nasal cavity antiallergic gel spray and preparation method thereof
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.
CN202210869476.3A 2022-07-22 2022-07-22 Nasal cavity antiallergic gel spray and preparation method thereof Pending CN117462493A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202210869476.3A CN117462493A (en) 2022-07-22 2022-07-22 Nasal cavity antiallergic gel spray and preparation method thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202210869476.3A CN117462493A (en) 2022-07-22 2022-07-22 Nasal cavity antiallergic gel spray and preparation method thereof

Publications (1)

Publication Number Publication Date
CN117462493A true CN117462493A (en) 2024-01-30

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Application Number Title Priority Date Filing Date
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