CN115006348A - Long-acting spray for oral mucosa and nasal mucosa, preparation method and application - Google Patents

Long-acting spray for oral mucosa and nasal mucosa, preparation method and application Download PDF

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Publication number
CN115006348A
CN115006348A CN202210811591.5A CN202210811591A CN115006348A CN 115006348 A CN115006348 A CN 115006348A CN 202210811591 A CN202210811591 A CN 202210811591A CN 115006348 A CN115006348 A CN 115006348A
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spray
mucosa
long
acting
oral
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费丽坤
鲁建国
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Zhende Medical Co Ltd
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Zhende Medical Co Ltd
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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
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/14Quaternary ammonium compounds, e.g. edrophonium, choline
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/74Synthetic polymeric materials
    • A61K31/785Polymers containing nitrogen
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Dispersion Chemistry (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Virology (AREA)
  • Otolaryngology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The invention discloses a long-acting oral mucosa and nasal mucosa spray and a preparation method thereof, wherein the spray is prepared from the following components in percentage by weight: 1-10% of antiviral active component, 1-5% of oligosaccharide, 0.05-5% of disinfection active component, 0.5-5% of adhesive, 3-15% of surfactant, 1-5% of humectant, 0.01-5% of pH regulator and the balance of solvent. The disinfection component and the antiviral component are compounded by the cationic active components, so that the synergy is strong, the disinfection and antiviral effects and the long-acting antibacterial effect are superior to those of a single-component formula, and the product performance is more stable; the spray contains factors beneficial to the growth of probiotics, and can promote the growth of the probiotics to balance the flora in oral mucosa and nasal mucosa while killing bacteria and viruses.

Description

Long-acting spray for oral mucosa and nasal mucosa, preparation method and application
Technical Field
The invention belongs to the technical field of disinfection and antiviral products, relates to a spray, and particularly relates to a long-acting spray for oral mucosa and nasal mucosa, a preparation method and application thereof.
Background
The mucous membrane is a layer of tissue structure covering the inner wall of the lumen of organs such as digestion, respiration, urinary, reproduction and the like in human body and consists of epithelial tissue and loose connective tissue. According to different parts, the mucous membrane of the mouth, the mucous membrane of the stomach and the intestine, the mucous membrane of the nasal cavity, the mucous membrane of the trachea, the mucous membrane of the vagina, the mucous membrane of the eyelid and other different names are provided. Their structures are also different depending on the function and the location. The nasal mucosa, called nasal mucosa for short, covers the nasal cavity surface, and cartilage, bone or skeletal muscle is below the mucosa. According to the difference of structure and function, the nasal mucosa is divided into a vestibule part, a breathing part and a sniffing part. The vestibule is the part adjacent to the external nostril, and abundant nose hair can block the inhalation of larger dust particles in the air. Oral mucosa refers to the moist lining within the oral cavity, having some of the characteristics of the skin and gut mucosa in function or structure.
The mucous membrane disinfection refers to the process of killing or removing pathogenic microorganisms of mucous membranes such as oral cavity, nasal cavity, vagina, external genitalia and the like, and meets the disinfection requirement. The GB27954-2020 general requirements for mucous membrane disinfectants clearly stipulates the limit of the disinfection active ingredients in the products and the safety requirements, for example, the eye irritation index is no irritation or light irritation, the mucous membrane irritation is no irritation or light irritation, and the like.
Oral mucosa infectious diseases such as stomatitis, oral ulcer, hand-foot-and-mouth disease and the like are mainly caused by infectious germs and viruses in oral cavities, so that the oral mucosa and the nasal mucosa are of great significance in daily life.
Disclosure of Invention
The invention aims to overcome the defects of the prior art and provide a long-acting spray for oral mucosa and nasal mucosa, and the spray is a colorless and tasteless product, effectively protects the nasal mucosa and the oral mucosa, effectively kills microorganisms and viruses on the mucosa, adheres to the surface of the mucosa, effectively protects the nasal mucosa for 72 hours, and effectively protects the oral mucosa for 24 hours. Meanwhile, the protective film contains substances for growing probiotics, so that the flora balance in the nasal mucosa and the oral mucosa can be effectively protected.
The second purpose of the invention is to provide a preparation method and application of the spray.
In order to achieve the purpose, the invention adopts the following technical scheme:
the invention firstly provides a long-acting spray for oral mucosa and nasal mucosa, which is prepared from the following components in percentage by weight: 1-10% of antiviral active component, 1-5% of oligosaccharide, 0.05-5% of disinfection active component, 0.5-5% of adhesive, 3-15% of surfactant, 1-5% of humectant, 0.01-5% of pH regulator and the balance of solvent.
In a preferred embodiment of the present invention, the antiviral active ingredient comprises at least one of N-alkyl propylamine glycine or quaternary ammonium salt.
As a preferred embodiment of the present invention, the oligosaccharide includes at least one of chitosan oligosaccharide or cellooligosaccharide.
In a preferred embodiment of the present invention, the disinfecting active ingredient comprises at least one of benzalkonium chloride or polyhexamethylene guanidine.
In a preferred embodiment of the present invention, the adhesive comprises at least one of polyvinyl alcohol PVA-1788, polyvinyl alcohol PVA-2088, or hydroxyethyl cellulose.
In a preferred embodiment of the present invention, the surfactant includes at least one of trimethylglycine or cetylpyridinium chloride.
In a preferred embodiment of the present invention, the humectant includes at least one of 1, 2-hexanediol, hyaluronic acid or ethylhexyl glycerin.
In a preferred embodiment of the present invention, the solvent is purified water.
The invention also provides a preparation method of the long-acting oral mucosa and nasal mucosa spray, which comprises the following steps:
1) weighing oligosaccharide and antiviral active ingredients according to the formula ratio, adding the oligosaccharide and the antiviral active ingredients into a solvent, and fully stirring, swelling and dispersing to obtain a solution A;
2) weighing the disinfection active ingredient, the adhesive, the surfactant and the humectant according to the formula ratio, adding the disinfection active ingredient, the adhesive, the surfactant and the humectant into the solution A obtained in the step 1), and fully stirring to obtain a solution B;
3) weighing a pH regulator according to the formula amount, adding the pH regulator into the solution B obtained in the step 2), fully stirring, complementing the solvent to 100%, and uniformly stirring to obtain the long-acting spray for oral mucosa and nasal mucosa.
The invention also provides the long-acting oral mucosa, and the application of the spray of the nasal mucosa in protecting the nasal mucosa and the oral mucosa, so that the nasal mucosa and the oral mucosa are effectively protected from being cleaned and sanitized, microorganisms and viruses on the mucosa are effectively killed, the spray is adhered to the surface of the mucosa, the nasal mucosa is effectively protected for 72 hours, the oral mucosa is effectively protected for 24 hours, and meanwhile, the protection film contains substances for growing probiotics, so that the flora balance in the nasal mucosa and the oral mucosa can be effectively protected.
Compared with the prior art, the invention has the following beneficial effects:
1) the disinfection component and the antiviral component are both compounded by cationic active components, the synergy is strong, the disinfection and antiviral effects and the long-acting antibacterial effect are superior to those of a single-component formula, and the product performance is more stable;
2) the spray contains factors beneficial to the growth of probiotics, and can promote the growth of the probiotics to balance the flora in oral mucosa and nasal mucosa while killing bacteria and viruses.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
The raw materials used in the present invention are all commercially available.
Example 1
The long-acting spray for oral mucosa and nasal mucosa provided by the embodiment comprises, by weight, 2% of chitosan oligosaccharide, 0.1% of a disinfection active ingredient PHMB, 3% of a polyvinyl alcohol PVA-17880.5% as an adhesive, 3% of trimethylglycine as a surfactant, 1% of hyaluronic acid as a humectant, 0.03% of a pH regulator, and the balance of purified water.
The preparation method comprises the following steps:
1) weighing 2 percent of chitosan oligosaccharide according to the formula weight, adding the chitosan oligosaccharide into a container with a proper amount of purified water, and fully stirring, swelling and dispersing to obtain a solution A.
2) Weighing 0.1% of disinfection active ingredient PHMB according to the formula ratio, adding the disinfection active ingredient PHMB into the solution A obtained in the step 1), and fully stirring to obtain a solution B.
3) Weighing polyvinyl alcohol PVA-17880.5%, trimethylglycine 3% and hyaluronic acid 1% according to the formula ratio, adding the polyvinyl alcohol PVA-17880.5%, the trimethylglycine 3% and the hyaluronic acid 1% into the solution B obtained in the step 2), and fully stirring to obtain a solution C.
4) Weighing 0.03% of pH regulator according to the formula amount, adding into the solution C obtained in the step 3), stirring thoroughly, adding purified water to complement, and stirring uniformly to obtain the spray.
Example 2:
according to the long-acting spray for the oral mucosa and the nasal mucosa, the antiviral component is 3% of quaternary ammonium salt, the oligosaccharide component is 2% of cellooligosaccharide, the adhesive is polyvinyl alcohol PVA-20880.5%, the surfactant is 3% of cetylpyridinium chloride, the humectant is 1, 2-hexanediol, the pH regulator is 0.03%, and the balance is purified water.
The preparation method comprises the following steps:
1) weighing 3% of quaternary ammonium salt and 2% of cellooligosaccharide according to the formula ratio, adding the quaternary ammonium salt and the cellooligosaccharide into a container with a proper amount of purified water, and fully stirring, swelling and dispersing to obtain a solution A.
2) Weighing polyvinyl alcohol PVA-20880.5%, cetylpyridinium chloride 3% and 1, 2-hexanediol 1% according to the formula ratio, adding the mixture into the solution A obtained in the step 2), and fully stirring to obtain a solution B.
3) Weighing 0.03% of pH regulator according to the formula amount, adding into the solution B obtained in the step 2), stirring thoroughly, adding purified water to complement, and stirring uniformly to obtain the spray.
Example 3:
the long-acting spray for oral mucosa and nasal mucosa provided by the embodiment comprises, by weight, 2% of antiviral component N-alkyl propylamino glycine, 3% of quaternary ammonium salt, 1% of oligosaccharide component chitosan oligosaccharide, 1% of cellooligosaccharide, 0.1% of disinfection active component PHMB, 0.1% of benzalkonium chloride, 0.78% of adhesive agent polyvinyl alcohol PVA-17880.1%, PVA-20880.1%, 0.3% of hydroxyethyl cellulose, 1% of surfactant trimethyl glycine, 1% of cetylpyridinium chloride, 1% of humectant trimethyl glycine, 1, 2-hexanediol, 0.05% of pH regulator, and the balance of purified water.
The preparation method comprises the following steps:
1) weighing 2% of N-alkyl propylamine glycine, 3% of quaternary ammonium salt, 1% of chitosan oligosaccharide and 1% of cellooligosaccharide according to the formula ratio, adding the mixture into a container with a proper amount of purified water, and fully stirring, swelling and dispersing to obtain a solution A.
2) Weighing 0.1% of disinfection active ingredient PHMB and 0.1% of benzalkonium chloride according to the formula ratio, adding the components into the solution A obtained in the step 1), and fully stirring to obtain a solution B.
3) Weighing polyvinyl alcohol PVA-17880.1%, PVA-20880.1%, hydroxyethyl cellulose 0.3%, trimethyl glycine 1%, cetyl pyridine chloride 1%, trimethyl glycine 1% and 1, 2-hexanediol 1% according to the formula ratio, adding into the solution B obtained in the step 2), and fully stirring to obtain a solution C.
4) Weighing 0.05% of pH regulator according to the formula amount, adding into the solution C obtained in the step 3), stirring fully, adding purified water to complement, and stirring uniformly to obtain the long-acting oral mucosa and nasal mucosa disinfection and antiviral spray.
Example 3 is superior to examples 1 and 2 by comparing the disinfecting effect and the indicating effect of examples 1-3, and the specific data are shown in tables 1 and 2:
TABLE 1 results of quantitative bacteria killing test according to Disinfection technical Specification 2002 edition, 2.1.1.7
Figure BDA0003739462090000041
Figure BDA0003739462090000051
Table 2. test results of detention bacteriostasis effect according to WS/T650 evaluation method of antibacterial and bacteriostasis effects 5.1.6
Figure BDA0003739462090000052
In conclusion, example 3 is superior to examples 1 and 2, and can effectively kill bacteria and viruses after 1-5 minutes of action, and can effectively resist bacteria for 24 hours on oral mucosa and can resist bacteria for 72 hours on nasal mucosa.
Meanwhile, the spray of the oral mucosa and the nasal mucosa contains factors beneficial to the growth of probiotics, and can promote the growth of the probiotics to balance the flora in the oral mucosa and the nasal mucosa while killing bacteria and viruses.
While the invention has been described with respect to a preferred embodiment, it will be understood by those skilled in the art that the foregoing and other changes, omissions and deviations in the form and detail thereof may be made without departing from the scope of this invention. Those skilled in the art can make various changes, modifications and equivalent arrangements, which are equivalent to the embodiments of the present invention, without departing from the spirit and scope of the present invention, and which may be made by utilizing the techniques disclosed above; meanwhile, any changes, modifications and variations of the above-described embodiments, which are equivalent to those of the technical spirit of the present invention, are within the scope of the technical solution of the present invention.

Claims (10)

1. The long-acting spray for the oral mucosa and the nasal mucosa is characterized by being prepared from the following components in percentage by weight: 1-10% of antiviral active component, 1-5% of oligosaccharide, 0.05-5% of disinfection active component, 0.5-5% of adhesive, 3-15% of surfactant, 1-5% of humectant, 0.01-5% of pH regulator and the balance of solvent.
2. The long-acting spray for oral and nasal mucosa according to claim 1, wherein the antiviral active component comprises at least one of N-alkyl propylaminylglycine or quaternary ammonium salt.
3. The long-acting spray for oral and nasal mucosa according to claim 1, wherein the oligosaccharide comprises at least one of chitosan oligosaccharide or cellooligosaccharide.
4. The spray for long-acting oral and nasal mucosa according to claim 1, wherein the disinfecting active comprises at least one of benzalkonium chloride or polyhexamethylene guanidine.
5. The spray for long-acting oral mucosa and nasal mucosa according to claim 1, wherein the adhesive comprises at least one of polyvinyl alcohol PVA-1788, polyvinyl alcohol PVA-2088 or hydroxyethyl cellulose.
6. The long-acting oral mucosa and nasal mucosa spray according to claim 1, wherein the surfactant comprises at least one of trimethylglycine or cetylpyridinium chloride.
7. The spray for treating oral mucosa and nasal mucosa according to claim 1, wherein the humectant comprises at least one of 1, 2-hexanediol, hyaluronic acid or ethylhexylglycerin.
8. The spray for long-acting oral mucosa and nasal mucosa according to any one of claims 1 to 7, wherein the solvent is purified water.
9. A method of preparing a long-acting oral and nasal mucosal spray as claimed in any one of claims 1 to 8, comprising the steps of:
1) weighing oligosaccharide and antiviral active ingredients according to the formula ratio, adding the oligosaccharide and the antiviral active ingredients into a solvent, and fully stirring, swelling and dispersing to obtain a solution A;
2) weighing the disinfection active ingredient, the adhesive, the surfactant and the humectant according to the formula ratio, adding the disinfection active ingredient, the adhesive, the surfactant and the humectant into the solution A obtained in the step 1), and fully stirring to obtain a solution B;
3) weighing a pH regulator according to the formula amount, adding the pH regulator into the solution B obtained in the step 2), fully stirring, complementing the solvent to 100%, and uniformly stirring to obtain the long-acting spray for oral mucosa and nasal mucosa.
10. Use of a long-acting oral mucosa, nasal mucosa spray, for the protection of the nasal mucosa and oral mucosa according to any one of claims 1 to 8.
CN202210811591.5A 2022-07-11 2022-07-11 Long-acting spray for oral mucosa and nasal mucosa, preparation method and application Pending CN115006348A (en)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104606137A (en) * 2015-01-07 2015-05-13 江苏迪沃生物制品有限公司 Antimicrobial repair-type nasal spray
CN105362225A (en) * 2015-11-06 2016-03-02 卫国刚 Propionic acid polyhexamethylene guanidine oral spray
CN111296500A (en) * 2020-03-20 2020-06-19 上海绿瑞生物科技有限公司 Disinfecting and sterilizing composition and preparation method thereof
CN111802409A (en) * 2020-06-23 2020-10-23 武汉理工大学 Broad-spectrum antiviral antibacterial disinfectant and preparation method and application thereof

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104606137A (en) * 2015-01-07 2015-05-13 江苏迪沃生物制品有限公司 Antimicrobial repair-type nasal spray
CN105362225A (en) * 2015-11-06 2016-03-02 卫国刚 Propionic acid polyhexamethylene guanidine oral spray
CN111296500A (en) * 2020-03-20 2020-06-19 上海绿瑞生物科技有限公司 Disinfecting and sterilizing composition and preparation method thereof
CN111802409A (en) * 2020-06-23 2020-10-23 武汉理工大学 Broad-spectrum antiviral antibacterial disinfectant and preparation method and application thereof

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