CN113876708A - Xylitol ear washing liquid spray and preparation thereof - Google Patents
Xylitol ear washing liquid spray and preparation thereof Download PDFInfo
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- CN113876708A CN113876708A CN202010629342.5A CN202010629342A CN113876708A CN 113876708 A CN113876708 A CN 113876708A CN 202010629342 A CN202010629342 A CN 202010629342A CN 113876708 A CN113876708 A CN 113876708A
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- Prior art keywords
- ear
- xylitol
- spray
- sodium chloride
- solution
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- 239000007921 spray Substances 0.000 title claims abstract description 32
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 title claims abstract description 29
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 title claims abstract description 29
- 239000000811 xylitol Substances 0.000 title claims abstract description 29
- 235000010447 xylitol Nutrition 0.000 title claims abstract description 29
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 title claims abstract description 29
- 229960002675 xylitol Drugs 0.000 title claims abstract description 29
- 238000002360 preparation method Methods 0.000 title abstract description 6
- 238000005406 washing Methods 0.000 title abstract description 5
- 239000007788 liquid Substances 0.000 title description 3
- 210000002939 cerumen Anatomy 0.000 claims abstract description 11
- 206010061218 Inflammation Diseases 0.000 claims abstract description 4
- 230000004054 inflammatory process Effects 0.000 claims abstract description 4
- 208000035143 Bacterial infection Diseases 0.000 claims abstract description 3
- 208000022362 bacterial infectious disease Diseases 0.000 claims abstract description 3
- 210000000613 ear canal Anatomy 0.000 claims abstract 4
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 56
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 41
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims description 30
- 239000011780 sodium chloride Substances 0.000 claims description 28
- 238000000034 method Methods 0.000 claims description 15
- 235000017557 sodium bicarbonate Nutrition 0.000 claims description 15
- 229910000030 sodium bicarbonate Inorganic materials 0.000 claims description 15
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 14
- CADWTSSKOVRVJC-UHFFFAOYSA-N benzyl(dimethyl)azanium;chloride Chemical compound [Cl-].C[NH+](C)CC1=CC=CC=C1 CADWTSSKOVRVJC-UHFFFAOYSA-N 0.000 claims description 13
- 238000003756 stirring Methods 0.000 claims description 12
- 229960000686 benzalkonium chloride Drugs 0.000 claims description 11
- 239000008213 purified water Substances 0.000 claims description 10
- 239000003906 humectant Substances 0.000 claims description 5
- 239000003755 preservative agent Substances 0.000 claims description 5
- 230000002335 preservative effect Effects 0.000 claims description 5
- 230000003204 osmotic effect Effects 0.000 claims description 3
- 230000001737 promoting effect Effects 0.000 claims description 3
- 210000000959 ear middle Anatomy 0.000 claims description 2
- 230000002421 anti-septic effect Effects 0.000 claims 2
- 238000005303 weighing Methods 0.000 claims 2
- 230000028327 secretion Effects 0.000 claims 1
- 230000000844 anti-bacterial effect Effects 0.000 abstract description 10
- 230000000694 effects Effects 0.000 abstract description 8
- 238000004140 cleaning Methods 0.000 abstract description 7
- 241000894006 Bacteria Species 0.000 abstract description 5
- 206010050337 Cerumen impaction Diseases 0.000 abstract description 3
- 238000009776 industrial production Methods 0.000 abstract description 2
- 206010053459 Secretion discharge Diseases 0.000 abstract 1
- 230000003467 diminishing effect Effects 0.000 abstract 1
- 230000000638 stimulation Effects 0.000 abstract 1
- 239000000243 solution Substances 0.000 description 29
- 235000002639 sodium chloride Nutrition 0.000 description 24
- 235000011187 glycerol Nutrition 0.000 description 15
- 239000000203 mixture Substances 0.000 description 7
- 238000009472 formulation Methods 0.000 description 6
- 238000002474 experimental method Methods 0.000 description 5
- 239000001963 growth medium Substances 0.000 description 5
- 238000013329 compounding Methods 0.000 description 4
- 238000012360 testing method Methods 0.000 description 4
- 241000606768 Haemophilus influenzae Species 0.000 description 3
- 206010033078 Otitis media Diseases 0.000 description 3
- KWYUFKZDYYNOTN-UHFFFAOYSA-M Potassium hydroxide Chemical compound [OH-].[K+] KWYUFKZDYYNOTN-UHFFFAOYSA-M 0.000 description 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
- 241000191967 Staphylococcus aureus Species 0.000 description 3
- 241000193998 Streptococcus pneumoniae Species 0.000 description 3
- 210000004027 cell Anatomy 0.000 description 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 3
- 238000011156 evaluation Methods 0.000 description 3
- 229940047650 haemophilus influenzae Drugs 0.000 description 3
- 238000011160 research Methods 0.000 description 3
- 229940031000 streptococcus pneumoniae Drugs 0.000 description 3
- 208000024891 symptom Diseases 0.000 description 3
- PUPZLCDOIYMWBV-UHFFFAOYSA-N (+/-)-1,3-Butanediol Chemical compound CC(O)CCO PUPZLCDOIYMWBV-UHFFFAOYSA-N 0.000 description 2
- TXFPEBPIARQUIG-UHFFFAOYSA-N 4'-hydroxyacetophenone Chemical compound CC(=O)C1=CC=C(O)C=C1 TXFPEBPIARQUIG-UHFFFAOYSA-N 0.000 description 2
- 206010011878 Deafness Diseases 0.000 description 2
- 239000006144 Dulbecco’s modified Eagle's medium Substances 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 2
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 description 2
- 230000002378 acidificating effect Effects 0.000 description 2
- 239000011248 coating agent Substances 0.000 description 2
- 238000000576 coating method Methods 0.000 description 2
- 238000012258 culturing Methods 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 230000029142 excretion Effects 0.000 description 2
- 210000002950 fibroblast Anatomy 0.000 description 2
- 230000006870 function Effects 0.000 description 2
- 230000010370 hearing loss Effects 0.000 description 2
- 231100000888 hearing loss Toxicity 0.000 description 2
- 208000016354 hearing loss disease Diseases 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- LXCFILQKKLGQFO-UHFFFAOYSA-N methylparaben Chemical compound COC(=O)C1=CC=C(O)C=C1 LXCFILQKKLGQFO-UHFFFAOYSA-N 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 230000035755 proliferation Effects 0.000 description 2
- 239000002994 raw material Substances 0.000 description 2
- 239000013558 reference substance Substances 0.000 description 2
- 239000012488 sample solution Substances 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 230000004083 survival effect Effects 0.000 description 2
- 210000003454 tympanic membrane Anatomy 0.000 description 2
- 238000009736 wetting Methods 0.000 description 2
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 description 1
- CHHHXKFHOYLYRE-UHFFFAOYSA-M 2,4-Hexadienoic acid, potassium salt (1:1), (2E,4E)- Chemical compound [K+].CC=CC=CC([O-])=O CHHHXKFHOYLYRE-UHFFFAOYSA-M 0.000 description 1
- QCDWFXQBSFUVSP-UHFFFAOYSA-N 2-phenoxyethanol Chemical compound OCCOC1=CC=CC=C1 QCDWFXQBSFUVSP-UHFFFAOYSA-N 0.000 description 1
- 229920001817 Agar Polymers 0.000 description 1
- KWIUHFFTVRNATP-UHFFFAOYSA-N Betaine Natural products C[N+](C)(C)CC([O-])=O KWIUHFFTVRNATP-UHFFFAOYSA-N 0.000 description 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 1
- 206010014020 Ear pain Diseases 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- 229930195725 Mannitol Natural products 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- KWIUHFFTVRNATP-UHFFFAOYSA-O N,N,N-trimethylglycinium Chemical compound C[N+](C)(C)CC(O)=O KWIUHFFTVRNATP-UHFFFAOYSA-O 0.000 description 1
- 208000002193 Pain Diseases 0.000 description 1
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 description 1
- 208000009205 Tinnitus Diseases 0.000 description 1
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 description 1
- 230000003213 activating effect Effects 0.000 description 1
- 230000004913 activation Effects 0.000 description 1
- 239000008272 agar Substances 0.000 description 1
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 description 1
- 229910000147 aluminium phosphate Inorganic materials 0.000 description 1
- 229940124350 antibacterial drug Drugs 0.000 description 1
- 239000003443 antiviral agent Substances 0.000 description 1
- 230000001580 bacterial effect Effects 0.000 description 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 1
- 229960003237 betaine Drugs 0.000 description 1
- 230000003115 biocidal effect Effects 0.000 description 1
- 238000012925 biological evaluation Methods 0.000 description 1
- 238000009395 breeding Methods 0.000 description 1
- 230000001488 breeding effect Effects 0.000 description 1
- 235000019437 butane-1,3-diol Nutrition 0.000 description 1
- 239000006143 cell culture medium Substances 0.000 description 1
- 230000003833 cell viability Effects 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 239000000850 decongestant Substances 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 238000007865 diluting Methods 0.000 description 1
- 238000010790 dilution Methods 0.000 description 1
- 239000012895 dilution Substances 0.000 description 1
- 239000012897 dilution medium Substances 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 210000005069 ears Anatomy 0.000 description 1
- 229960001617 ethyl hydroxybenzoate Drugs 0.000 description 1
- 235000010228 ethyl p-hydroxybenzoate Nutrition 0.000 description 1
- 239000004403 ethyl p-hydroxybenzoate Substances 0.000 description 1
- NUVBSKCKDOMJSU-UHFFFAOYSA-N ethylparaben Chemical compound CCOC(=O)C1=CC=C(O)C=C1 NUVBSKCKDOMJSU-UHFFFAOYSA-N 0.000 description 1
- 235000003869 genetically modified organism Nutrition 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 235000001727 glucose Nutrition 0.000 description 1
- 229960005150 glycerol Drugs 0.000 description 1
- 210000003128 head Anatomy 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- ACCCMOQWYVYDOT-UHFFFAOYSA-N hexane-1,1-diol Chemical compound CCCCCC(O)O ACCCMOQWYVYDOT-UHFFFAOYSA-N 0.000 description 1
- 239000005556 hormone Substances 0.000 description 1
- 229940088597 hormone Drugs 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 230000002458 infectious effect Effects 0.000 description 1
- 208000027866 inflammatory disease Diseases 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 239000000594 mannitol Substances 0.000 description 1
- 235000010355 mannitol Nutrition 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 235000010270 methyl p-hydroxybenzoate Nutrition 0.000 description 1
- 239000004292 methyl p-hydroxybenzoate Substances 0.000 description 1
- 229960002216 methylparaben Drugs 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 230000000510 mucolytic effect Effects 0.000 description 1
- 239000007923 nasal drop Substances 0.000 description 1
- 229940100662 nasal drops Drugs 0.000 description 1
- 239000007922 nasal spray Substances 0.000 description 1
- 229940097496 nasal spray Drugs 0.000 description 1
- 238000006386 neutralization reaction Methods 0.000 description 1
- 208000005923 otitis media with effusion Diseases 0.000 description 1
- 230000036407 pain Effects 0.000 description 1
- 238000011056 performance test Methods 0.000 description 1
- 229960005323 phenoxyethanol Drugs 0.000 description 1
- 239000002504 physiological saline solution Substances 0.000 description 1
- 239000011736 potassium bicarbonate Substances 0.000 description 1
- 235000015497 potassium bicarbonate Nutrition 0.000 description 1
- 229910000028 potassium bicarbonate Inorganic materials 0.000 description 1
- 239000001103 potassium chloride Substances 0.000 description 1
- 235000011164 potassium chloride Nutrition 0.000 description 1
- TYJJADVDDVDEDZ-UHFFFAOYSA-M potassium hydrogencarbonate Chemical compound [K+].OC([O-])=O TYJJADVDDVDEDZ-UHFFFAOYSA-M 0.000 description 1
- 235000010241 potassium sorbate Nutrition 0.000 description 1
- 239000004302 potassium sorbate Substances 0.000 description 1
- 229940069338 potassium sorbate Drugs 0.000 description 1
- 239000000523 sample Substances 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 208000024036 serous otitis media Diseases 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 231100000886 tinnitus Toxicity 0.000 description 1
- 230000009261 transgenic effect Effects 0.000 description 1
- 239000008215 water for injection Substances 0.000 description 1
- 239000000080 wetting agent Substances 0.000 description 1
Classifications
-
- 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
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
- A61K31/047—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates having two or more hydroxy groups, e.g. sorbitol
-
- 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
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K9/0046—Ear
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/16—Otologicals
-
- 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
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/02—Local antiseptics
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Dispersion Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Pain & Pain Management (AREA)
- Rheumatology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
The project aims to develop an ear washing spray for cleaning earwax caused by serious ear canal, the main component is xylitol, and the ear washing spray has intentional antibacterial performance, so that the ear washing spray has the effects of resisting bacteria and diminishing inflammation while removing dirt, and the preparation method is simple, has stable performance, can reduce stimulation to the ear canal, can promote mucus discharge in the ear canal, and has the effect of preventing bacterial infection. Convenient use and is suitable for industrial production.
Description
The technical field is as follows: the invention belongs to the field of medical appliances, and particularly relates to an ear spray containing xylitol as a main component and a preparation method thereof.
Second, background Art
Secretory otitis media is one of common diseases in the ear, is a middle ear non-suppurative inflammatory disease which is mainly characterized by hearing loss and tympanophagia, is mainly caused by inflammation induced by bacterial infection of streptococcus pneumoniae, staphylococcus aureus, haemophilus influenzae and the like, and has the following symptoms: hearing loss, mild ear pain, tinnitus, ear fullness and occlusion, and an audible water sound with shaking head. The special otology examination shows that the tympanic membrane is in amber color or dark color, and also shows the symptoms of gas-liquid plane or bubbles, reduced activity of the tympanic membrane, and the like.
At present, the drug treatment of otitis media mainly comprises the treatment of antibacterial drugs, antiviral drugs, oral hormones, decongestant nasal drops, mucolytic excretion promoting agents and the like; although effective, it has high cost, poor effect and side effects.
Third, the invention
Aiming at the defects of the ear spray, the project discloses the ear spray which is efficient in bacteriostasis and has a discharge promoting effect, the xylitol is used as a main component, the efficient bacteriostasis performance of the ear spray effectively prevents and prevents bacteria from breeding, a preservative is not required to be added, and the damage to tissues in ears can be reduced. Earwax secreted by inflammation is easily removed.
The technical scheme of the invention is as follows: the ear spray containing xylitol is characterized by comprising the following raw and auxiliary materials in percentage by weight: xylitol, humectant, osmotic pressure regulator, preservative, proper amount of pH regulator, and water for injection to 100%. The method comprises the following specific steps:
1) all reagents were sterilized rigorously before use;
2) dissolving sodium chloride in purified water at normal temperature to prepare 0.9% sodium chloride solution;
3) adding xylitol, glycerol and benzalkonium chloride into sodium chloride solution at normal temperature, and stirring to be clear and transparent;
4) adding sodium bicarbonate into the solution at normal temperature;
5) and (5) continuously stirring to room temperature at normal temperature, and sampling and detecting.
The osmotic pressure regulator is one or more of sodium chloride, glycerol, mannitol, glucose and potassium chloride.
The humectant is one or more of glycerol, 1, 3-butanediol, trehalose, betaine and hexanediol.
The pH value regulator is one or more of citric acid, hydrochloric acid, phosphoric acid, sodium hydroxide, potassium hydroxide, sodium bicarbonate and potassium bicarbonate.
The preservative is one or more of phenoxyethanol, p-hydroxyacetophenone, methylparaben, ethylparaben, potassium sorbate and benzalkonium chloride.
The ear spray prepared by the prescription and the method of the invention has the following functions: the traditional Chinese medicine composition has an obvious treatment effect on otitis media, can obviously improve symptoms of patients, and greatly relieves pains of the patients. The main components of the invention have the functions of antibiosis and antiphlogosis and excretion promotion, no preservative is needed to be added, the damage to the tissues in the ear is reduced, and the environment in the ear of a patient is kept clean. Meanwhile, the product is simple to prepare, convenient to use and universal for industrial production.
Fourth, detailed description of the invention
The invention is not limited to the specific embodiments listed below, but also includes any combination of variables between the embodiments.
Embodiment 1
Formulation 1
The method comprises the following specific operations: according to the mass percentage, sodium chloride is dissolved in purified water at normal temperature to prepare 0.9% sodium chloride solution, 5% xylitol is weighed and added into the sodium chloride solution, the solution is stirred and dissolved, then 0.1% glycerol and 0.02% benzalkonium chloride are added into the solution, the solution is stirred and dissolved, and finally sodium bicarbonate is added to adjust the pH value.
Example 2
Formulation 2
The method comprises the following steps: according to the mass percentage, sodium chloride is dissolved in purified water at normal temperature to prepare 0.9% sodium chloride solution, 10% xylitol is weighed and added into the sodium chloride solution, the solution is stirred and dissolved, then 0.4% glycerin and 0.02% benzalkonium chloride are added into the solution, the solution is stirred and dissolved, and finally sodium bicarbonate is added to adjust the pH value.
Embodiment 3
Formulation 3
The method comprises the following specific operations: according to the mass percentage, sodium chloride is dissolved in purified water at normal temperature to prepare 0.9% sodium chloride solution, 15% xylitol is weighed and added into the sodium chloride solution, stirring and dissolving are carried out, then 0.5% glycerin and 0.02% benzalkonium chloride are added into the solution, stirring and dissolving are carried out, and finally sodium bicarbonate is added to adjust the pH value.
Example 4
Formulation 4
| Raw materials | Ratio (%) |
| Purified water | to 100 |
| Sodium chloride 1 | 0.9 |
| Xylitol, its preparation method and use | 15 |
| Glycerin | 0.6 |
| Benzalkonium chloride (III) | 0.2 |
| Sodium bicarbonate 2 | 0.003 |
The method comprises the following specific operations: according to the mass percentage, sodium chloride is dissolved in purified water at normal temperature to prepare 0.9% sodium chloride solution, 15% xylitol is weighed and added into the sodium chloride solution, stirring and dissolving are carried out, then 0.6% glycerin and 0.02% benzalkonium chloride are added into the solution, stirring and dissolving are carried out, and finally sodium bicarbonate is added to adjust the pH value.
Example 5
Formulation 5
The method comprises the following specific operations: according to the mass percentage, sodium chloride is dissolved in purified water at normal temperature to prepare 0.9% sodium chloride solution, 20% xylitol is weighed and added into the sodium chloride solution, stirring and dissolving are carried out, then 0.7% glycerin and 0.02% benzalkonium chloride are added into the solution, stirring and dissolving are carried out, and finally sodium bicarbonate is added to adjust the pH value.
Example 6
Formulation 6
| Raw materials | Ratio (%) |
| Purified water | to 100 |
| Sodium chloride 1 | 0.9 |
| Xylitol, its preparation method and use | 20 |
| Glycerin | 1 |
| Benzalkonium chloride (III) | 0.2 |
| Sodium bicarbonate 2 | 0.004 |
The method comprises the following specific operations: according to the mass percentage, sodium chloride is dissolved in purified water at normal temperature to prepare 0.9% sodium chloride solution, 20% xylitol is weighed and added into the sodium chloride solution, stirring and dissolving are carried out, then 0.7% glycerin and 0.02% benzalkonium chloride are added into the solution, stirring and dissolving are carried out, and finally sodium bicarbonate is added to adjust the pH value.
pH value test of product
The existence of the sodium bicarbonate solution can play a role in acid-base neutralization on the acidic environment in the system, when the sodium bicarbonate does not exist in the system, the system is in a slightly acidic environment, namely the pH value is about 6.3, the pH value of the product can be obviously changed along with the continuous increase of the mass concentration of the sodium bicarbonate, namely the pH value is increased, and the formula 2 meets the requirement, so that the mass concentration of the sodium bicarbonate is fixed to be 0.01% (small dose) as the compounding proportion.
Product moisture retention Performance test
By analyzing the existing product, in order to achieve the effects of wetting and softening cerumen (ear wax), a wetting agent can be selected for product compounding. Therefore, the formula selects glycerol. As shown in the table, the wetting and softening effects of the product are obviously enhanced along with the increase of the mass concentration of the glycerol, and the formula 4, the formula 5 and the formula 6 can be used, but the formula 4 is selected in consideration of the addition amount, the mass concentration of the glycerol is fixed to be 1 percent, and the glycerol is used as the compounding ratio.
Test of antibacterial Property
The antibacterial performance of the product is evaluated by taking haemophilus influenzae, staphylococcus aureus and streptococcus pneumoniae as evaluation strains and taking a colony counting method as an evaluation index.
According to the literature, xylitol has antibacterial activity, but xylitol with low concentration has no obvious antibacterial activity, and as shown in the table, the antibacterial activity in the system is enhanced along with the increase of the mass concentration of the xylitol, so that the formula 3 is selected, the mass concentration of the xylitol is fixed at 15%, and the formula is used as the compounding ratio.
Evaluation of biological safety of products
To avoid the risks posed by the health and safety of humans and the protection of the environment due to research and commercial production of organisms with infectious capacity or genetically modified organisms. The biological safety performance emphasizes the safety of the transgenic biotechnology and the genetically modified products thereof to human, animals, plants and environment. Biological safety refers to the safety problem of biotechnology in the whole process from research, development, production to practical application. The MTT method is adopted to evaluate the biological safety performance of the product.
Pretreatment before experiment
Taking French Quies cerumen cleaning spray as a reference substance, taking prepared xylitol cerumen cleaning spray as an experimental group, preparing a culture solution by adopting a DMEM cell culture medium, and preparing a sample solution by adopting the volume ratio of the DMEM culture medium to the xylitol cerumen cleaning spray/the Quies cerumen cleaning spray of 9: 1. Mouse embryonic fibroblasts (NIH-3T3) were experimental cells and cell viability was measured quantitatively using MTT.
Results of the experiment
In the culture process of 1 day, 2 days and 3 days, the cell survival rates of the ear spray product and the standard product are higher, namely, mouse fibroblasts (L929) keep higher survival capacity (higher than 90 percent) and show normal growth and proliferation capacity, which indicates that the ear spray product prepared by the research personnel has good biocompatibility and can not inhibit the normal proliferation of cells. There were no significant statistical differences between the ear spray product and the control product, and these experimental data indicate that the ear spray product has high biocompatibility.
049 biological evaluation of antibacterial property of product
Pretreatment before experiment
Sample treatment: taking French Quies cerumen cleaning spray as a reference substance, taking xylitol nasal spray as an experimental substance, and mixing the substances according to the ratio of physiological saline: the sample solution was prepared with xylitol ear spray/Quies cerumen cleaning spray volume ratio of 9: 1.
Activation culture of bacteria: taking out test bacteria (Haemophilus influenzae, Staphylococcus aureus, and Streptococcus pneumoniae) from refrigerator at-4 deg.C, inoculating into agar culture medium, and activating and culturing at 37 deg.C for 12 hr
Experimental methods
The test procedure of the dilution medium counting method is as follows:
1) measuring the viable count of each milliliter of original culture solution by a dilution culture medium counting Method (MPN), and diluting the original culture solution to about 100CFU/mL according to the result obtained by the MPN;
2) sucking 20 μ L of the bacterial suspension into a plate of solid culture medium containing extract, uniformly coating with a bacteria coating rod, standing for 15min, and culturing the culture medium plate in a biochemical incubator at 37 deg.C for 24 hr by inverting (preventing dripping of condensed water from the dish cover);
3) the number of colonies was counted, the number of colonies of the control group was counted as C0, the number of colonies of the extract-coated plate was counted as C,
4) and (5) calculating the bacteriostasis rate.
Results of the experiment
The test results are shown in the table, and compared with the standard product, the antibacterial results of the product show no obvious statistical difference, and show better antibacterial capability, and the antibacterial activity reaches about 90%.
Claims (9)
1. A xylitol ear spray comprises xylitol, humectant, osmotic pressure regulator, pH regulator, antiseptic, and injectable water; it is characterized in that the content of xylitol as an effective component is 5-20%.
2. The ear spray of claim 1, wherein the xylitol is present in an amount of 5-20%.
3. The ear spray of claim 1, wherein the humectant is present in an amount of 0-2%.
4. The ear spray of claim 1, wherein the sodium chloride is present in an amount of 0.9%.
5. The ear spray of claim 1, wherein the sodium bicarbonate is present in an amount of 0-0.005%.
6. The ear spray of claim 1, wherein the pH is from 6 to 8.
7. The ear spray of claim 1, wherein the preservative is present in an amount of 0.2%.
8. A method for preparing the middle ear spray of claim 1, which comprises the following steps:
dissolving sodium chloride into purified water at normal temperature to prepare 0.9 percent sodium chloride solution; weighing 5-20% of xylitol, adding into sodium chloride solution, weighing 0-2% of humectant glycerol, adding into the above solution, stirring for dissolving, adding 0.2% of antiseptic benzalkonium chloride, adding into the solution, stirring for dissolving, and adding sodium bicarbonate to adjust pH value of the ear spray.
9. The spray of claim 1 for use in removing cerumen due to inflammation, promoting secretion removal, and preventing bacterial infection in the ear canal.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010629342.5A CN113876708A (en) | 2020-07-02 | 2020-07-02 | Xylitol ear washing liquid spray and preparation thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202010629342.5A CN113876708A (en) | 2020-07-02 | 2020-07-02 | Xylitol ear washing liquid spray and preparation thereof |
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| CN113876708A true CN113876708A (en) | 2022-01-04 |
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| CN202010629342.5A Pending CN113876708A (en) | 2020-07-02 | 2020-07-02 | Xylitol ear washing liquid spray and preparation thereof |
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- 2020-07-02 CN CN202010629342.5A patent/CN113876708A/en active Pending
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Application publication date: 20220104 |