CN112972516A - A disinfectant product for treating otitis externa - Google Patents

A disinfectant product for treating otitis externa Download PDF

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CN112972516A
CN112972516A CN202110211310.8A CN202110211310A CN112972516A CN 112972516 A CN112972516 A CN 112972516A CN 202110211310 A CN202110211310 A CN 202110211310A CN 112972516 A CN112972516 A CN 112972516A
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parts
product
oil
otitis externa
otitis
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CN112972516B (en
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赵琳
师新伟
张伟
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Heilongjiang Bifujin North Pharmaceutical Co ltd
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Henan Bifu Pharmaceutical Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/282Artemisia, e.g. wormwood or sagebrush
    • 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
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A61K31/3533,4-Dihydrobenzopyrans, e.g. chroman, catechin
    • A61K31/355Tocopherols, e.g. vitamin E
    • 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
    • A61K9/0046Ear
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/16Otologicals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/02Local antiseptics
    • 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
    • A61P31/10Antimycotics

Abstract

The invention discloses a disinfection product for otitis externa, and belongs to the technical field of disinfection products. The external otitis disinfection product provided by the invention comprises the following active components: (1) one of benzalkonium bromide, benzalkonium chloride and polyhexamethylene biguanide, or a pharmaceutically acceptable salt of any of the foregoing; (2) oil of Artemisia Sus Domestica; (3) and (3) vitamin E. The invention also provides a preparation method of the disinfection product for otitis externa. The disinfection product for the otitis externa provided by the invention is natural in raw materials, can effectively kill fungi, prevent infection recurrence, reduce drug resistance, improve the environment of the external auditory canal while treating inflammation and promote the repair of the mucous membrane of the external auditory canal, is safe and non-irritant to the mucous membrane of the external auditory canal, and has good application prospect.

Description

A disinfectant product for treating otitis externa
Technical Field
The invention relates to the technical field of disinfection products, in particular to a disinfection product for otitis externa.
Background
Otitis externa is a common clinical otological disease, and the more common pathogenic bacteria include streptococcus, staphylococcus aureus, pseudomonas aeruginosa, proteus and the like. Due to the fact that autoimmunity is reduced, a large systemic dose of antibiotics is used for a long time, and the like, the beneficial factors are caused to breeding of external auditory canal bacteria, multiple drug-resistant bacteria and/or fungal infection are common, and the incidence rate of the diseases is on the rising trend year by year in recent years. The clinical main symptoms comprise ear itch, swelling, pain or suppuration and the like, and the disease has high incidence rate, slow progress, easy repetition and difficult radical cure.
At present, the external otitis is clinically treated by two modes of oral medicaments and external medicaments, the oral medicaments play a role of the whole body, have no targeting property and are easy to generate adverse reactions; the external medicinal preparation has strong targeting property, high local medicine concentration and slight adverse reaction. However, the existing external preparation for clinically treating otitis externa has low selectivity, and particularly has low selectivity in the aspect of disinfection products for otitis externa. Antibacterial drugs are usually selected for treating the external otitis clinically, but the antibacterial drugs have obvious defects and unsatisfactory curative effects, and the phenomena of repeated attack of patients, high incidence of adverse reactions, long medication treatment period and the like exist. The otitis externa is usually treated by dropping hydrogen peroxide, sodium bicarbonate solution and the like into the auditory canal for cleaning and then dropping antibacterial drugs into the auditory canal, but the method has a complex process and certain physiological irritation and toxicity.
Therefore, the research and development of the disinfection product for the otitis externa, which has good stability, high sterilization rate, high safety and no irritation, can reduce drug resistance at the same time, and has important significance.
Disclosure of Invention
Aiming at the defects in the prior art, the invention provides a disinfection product for otitis externa, which has good stability, high sterilization rate, high safety and no irritation, and can reduce drug resistance.
The purpose of the invention is realized by the following technical scheme:
a disinfecting product for otitis externa comprising the following active ingredients: (1) one of benzalkonium bromide, benzalkonium chloride and polyhexamethylene biguanide, or a pharmaceutically acceptable salt of any of the foregoing; (2) oil of Artemisia Sus Domestica; (3) and (3) vitamin E.
Further, the oil of artemisia pigweed contains the following components: 1-phenyl-2, 4-pentadiyne (content ratio is 0.38%), eugenol (content ratio is 10.10%), hexa-2, 4-diynylbenzene (content ratio is 41.24%), rutinosenol (content ratio is 7.10%), caryophyllene oxide (content ratio is 10.51%), 2, 4-hexadiyne phenylketone (content ratio is 5.81%), spiro (9-methylenetricyclo [6.2.1.0(2,7) ] undecene-2, 4, 6-triene) -11,1' -cyclopropane (content ratio is 5.59%).
Further, the disinfection product for otitis externa comprises the following components in parts by mass: 0.01-0.2 part of benzalkonium bromide or medicinal salt thereof, 0.4-0.8 part of artemisia oil and 0.1-0.5 part of vitamin E.
Further, the disinfectant product for external otitis also comprises other auxiliary agents, wherein the other auxiliary agents are one or more of glyceryl stearate, white vaseline, lanolin, liquid paraffin, stearic acid, stearyl alcohol, sodium dodecyl sulfate, polysorbate 80, glycerin and propylene glycol.
Further, the other auxiliary agents also comprise one or two of ethyl hydroxybenzoate and propyl hydroxybenzoate.
Further, the disinfection product for otitis externa comprises the following components in parts by mass: 0.015 part of benzalkonium bromide or medicinal salt thereof, 0.5 part of artemisia pigweed oil, 0.5 part of vitamin E, 15-21 parts of glyceryl stearate, 20-30 parts of liquid paraffin, 6-11 parts of white vaseline, 2 parts of stearic acid, 6-12 parts of propylene glycol, 1-2 parts of sodium dodecyl sulfate, 0.02 part of ethylparaben and the balance of distilled water.
Further, the disinfection product for otitis externa comprises the following components in parts by mass: 0.015 part of benzalkonium bromide or medicinal salt thereof, 0.5 part of artemisia pigweed oil, 0.5 part of vitamin E, 15 parts of glyceryl stearate, 20 parts of liquid paraffin, 10 parts of white vaseline, 2 parts of stearic acid, 10 parts of propylene glycol, 2 parts of sodium dodecyl sulfate, 0.02 part of ethylparaben and the balance of distilled water.
A method for preparing a disinfectant product for otitis externa comprising the steps of:
1) putting the glyceryl stearate, the white vaseline, the liquid paraffin and the stearic acid into a container, and heating and melting at 70-80 ℃ to obtain an oil phase;
2) adding propylene glycol, sodium dodecyl sulfate, ethylparaben, benzalkonium bromide, vitamin E and artemisia pigskin oil into distilled water, and heating to 70-80 ℃ to be used as a water phase;
3) adding the water phase into the oil phase under stirring, continuously stirring until the mixture becomes cool to form emulsion matrix type ointment, and subpackaging the ointment into tubes to obtain the disinfection product for otitis externa of the invention.
The external otitis disinfection product provided by the invention can be prepared into external auditory canal disinfection spray, or external auditory canal cleaning solution, ear drop, ointment or paste, or external auditory canal disinfection gel and earplug, or external auditory canal disinfection solid preparation.
Compared with the prior art, the invention has the following beneficial effects:
(1) the invention starts from effectiveness, and the benzalkonium bromide or the medicinal salt thereof is matched with the artemisia pigweed oil for use, so that the synergistic effect is achieved, and the sterilization effect is enhanced. Benzalkonium bromide is a cationic surfactant type broad-spectrum bacteriostatic agent, can change the permeability of a bacterial cytoplasmic membrane, enables bacterial cytoplasmic substances to seep outwards, and blocks the metabolism of the bacterial cytoplasmic substances to play a role in killing; meanwhile, the plant natural extract of the artemisia pigweed oil can effectively kill bacteria and fungi, the effective concentration is low, and compared with the existing chemical antibacterial drugs, the artemisia pigweed oil has no drug resistance, and the recurrence rate of the otitis externa can be well reduced.
(2) The invention starts from safety, the benzalkonium bromide is stable in property, has no stimulation to skin with the concentration of less than 0.1 percent, and is suitable for mucosa disinfection before operation; the artemisia pigweed oil is extracted from plants, is pure natural, mild, non-irritant, safe and non-toxic; in addition, the vitamin E is compounded, so that the mucous membrane of the external auditory canal is protected, the external auditory canal environment is improved while the inflammation is treated, the mucous membrane of the external auditory canal is repaired, and the vitamin E is safe and non-irritant to the mucous membrane of the external auditory canal.
(3) The external disinfectant disclosed by the invention is an external disinfectant, directly acts on the external auditory canal part, is safe and non-irritant, is convenient to use, and can obviously improve the compliance of a patient.
Drawings
FIG. 1 is a chromatogram of oil derived from Artemisia Sus Domestica.
FIG. 2 is a mass spectrum of peak No. 1.
FIG. 3 is a mass spectrum of peak No. 2.
FIG. 4 is a mass spectrum of peak No. 3.
FIG. 5 is a mass spectrum of peak No. 4.
FIG. 6 is a mass spectrum of peak No. 5.
FIG. 7 is a mass spectrum of peak No. 6.
FIG. 8 is a mass spectrum of peak No. 7.
Detailed Description
To further illustrate the technical measures taken by the present invention and the effects thereof, the following detailed description is given with reference to preferred embodiments of the present invention.
Example 1
A disinfection product for otitis externa comprises the following components in parts by weight: 0.015 part of benzalkonium bromide or medicinal salt thereof, 0.4 part of artemisia pigweed oil, 0.5 part of vitamin E, 15 parts of glyceryl stearate, 20 parts of liquid paraffin, 10 parts of white vaseline, 2 parts of stearic acid, 10 parts of propylene glycol, 2 parts of sodium dodecyl sulfate, 0.02 part of ethylparaben and the balance of distilled water.
The preparation method comprises the following steps: 1) putting the glyceryl stearate, the white vaseline, the liquid paraffin and the stearic acid into a container, and heating and melting at 70-80 ℃ to obtain an oil phase; 2) adding propylene glycol, sodium dodecyl sulfate, ethylparaben, benzalkonium bromide or pharmaceutically acceptable salts thereof, vitamin E and oil of Artemisia Sus Domestica into distilled water, and heating to 70-80 deg.C to obtain water phase; 3) adding the water phase into the oil phase under stirring, continuously stirring until the mixture becomes cool to form emulsion matrix type ointment, and subpackaging the ointment into tubes to obtain the disinfection product for otitis externa of the invention.
Example 2
A disinfection product for otitis externa comprises the following components in parts by weight: 0.01 part of benzalkonium bromide or medicinal salt thereof, 0.5 part of artemisia pigweed essential oil, 0.5 part of vitamin E, 15 parts of glyceryl stearate, 15 parts of liquid paraffin, 10 parts of white vaseline, 2 parts of stearic acid, 10 parts of propylene glycol, 2 parts of sodium dodecyl sulfate, 0.02 part of ethylparaben and the balance of distilled water.
The preparation method comprises the following steps: 1) putting the glyceryl stearate, the white vaseline, the liquid paraffin and the stearic acid into a container, and heating and melting at 70-80 ℃ to obtain an oil phase; 2) adding propylene glycol, sodium dodecyl sulfate, ethylparaben, benzalkonium bromide or pharmaceutically acceptable salts thereof, vitamin E and oil of Artemisia Sus Domestica into distilled water, and heating to 70-80 deg.C to obtain water phase; 3) adding the water phase into the oil phase under stirring, continuously stirring until the mixture becomes cool to form emulsion matrix type ointment, and subpackaging the ointment into tubes to obtain the disinfection product for otitis externa of the invention.
Example 3
A disinfection product for otitis externa, namely an external auditory canal cleaning solution, comprises the following components in parts by mass: 0.02 part of benzalkonium bromide or medicinal salt thereof, 0.6 part of artemisia pigweed essential oil, 0.5 part of vitamin E, 19 parts of glyceryl stearate, 10 parts of liquid paraffin, 8 parts of white vaseline, 2 parts of stearic acid, 10 parts of propylene glycol, 802 parts of polysorbate, 0.02 part of ethylparaben and the balance of distilled water.
The preparation method comprises the following steps: 1) putting stearic acid, white vaseline, liquid paraffin and stearic acid into a container, and heating and melting at 70-80 ℃ to obtain an oil phase; 2) adding polysorbate 80, propylene glycol, glycerol, ethylparaben, benzalkonium bromide or pharmaceutically acceptable salts thereof, vitamin E and oil of Artemisia Sus Domestica into distilled water dissolved with methyl cellulose, and heating to 70-80 deg.C to obtain water phase; 3) adding the water phase into the oil phase under stirring, continuously stirring until the mixture becomes cool to form emulsion matrix type ointment, and subpackaging the ointment into tubes to obtain the disinfection product for otitis externa of the invention.
Example 4
A disinfection product for otitis externa, namely an external auditory canal cleaning solution, comprises the following components in parts by mass: 0.015 part of benzalkonium bromide or medicinal salt thereof, 0.5 part of artemisia pigweed oil, 0.5 part of vitamin E, 15 parts of glyceryl stearate, 20 parts of liquid paraffin, 10 parts of white vaseline, 2 parts of stearic acid, 10 parts of propylene glycol, 2 parts of sodium dodecyl sulfate, 0.02 part of ethylparaben and the balance of distilled water.
The preparation method comprises the following steps: 1) putting stearic acid, white vaseline, liquid paraffin and stearic acid into a container, and heating and melting at 70-80 ℃ to obtain an oil phase; 2) adding sodium dodecyl sulfate, propylene glycol, glycerol, ethylparaben, benzalkonium bromide or pharmaceutically acceptable salts thereof, vitamin E and oil of Artemisia Sus Domestica into distilled water dissolved with methyl cellulose, and heating to 70-80 deg.C to obtain water phase; 3) adding the water phase into the oil phase under stirring, continuously stirring until the mixture becomes cool to form emulsion matrix type ointment, and subpackaging the ointment into tubes to obtain the disinfection product for otitis externa of the invention.
Example 5
A disinfection product for otitis externa, namely an external auditory canal cleaning solution, comprises the following components in parts by mass: 0.2 part of benzalkonium bromide or medicinal salt thereof, 0.8 part of artemisia pigweed oil, 0.4 part of vitamin E, 21 parts of glyceryl stearate, 30 parts of liquid paraffin, 11 parts of white vaseline, 2 parts of stearic acid, 12 parts of propylene glycol, 2 parts of sodium dodecyl sulfate, 0.02 part of ethylparaben and the balance of distilled water.
The preparation method comprises the following steps: 1) putting stearic acid, white vaseline, liquid paraffin and stearic acid into a container, and heating and melting at 70-80 ℃ to obtain an oil phase; 2) adding sodium dodecyl sulfate, propylene glycol, glycerol, ethylparaben, benzalkonium bromide or pharmaceutically acceptable salts thereof, vitamin E and oil of Artemisia Sus Domestica into distilled water dissolved with methyl cellulose, and heating to 70-80 deg.C to obtain water phase; 3) adding the water phase into the oil phase under stirring, continuously stirring until the mixture becomes cool to form emulsion matrix type ointment, and subpackaging the ointment into tubes to obtain the disinfection product for otitis externa of the invention.
Example 6
A disinfection product for otitis externa, namely an external auditory canal cleaning solution, comprises the following components in parts by mass: 0.01 part of benzalkonium bromide or medicinal salt thereof, 0.4 part of artemisia pigweed oil, 0.1 part of vitamin E, 14 parts of glyceryl stearate, 16 parts of liquid paraffin, 5 parts of white vaseline, 1.5 parts of stearic acid, 5 parts of propylene glycol, 1 part of sodium dodecyl sulfate, 0.016 part of ethylparaben and the balance of distilled water.
The preparation method comprises the following steps: 1) putting stearic acid, white vaseline, liquid paraffin and stearic acid into a container, and heating and melting at 70-80 ℃ to obtain an oil phase; 2) adding sodium dodecyl sulfate, propylene glycol, glycerol, ethylparaben, benzalkonium bromide or pharmaceutically acceptable salts thereof, vitamin E and oil of Artemisia Sus Domestica into distilled water dissolved with methyl cellulose, and heating to 70-80 deg.C to obtain water phase; 3) adding the water phase into the oil phase under stirring, continuously stirring until the mixture becomes cool to form emulsion matrix type ointment, and subpackaging the ointment into tubes to obtain the disinfection product for otitis externa of the invention.
Comparative example 1
The procedure is as in example 4 except that the oil of Artemisia Sus Domestica is not contained.
Comparative example 2
The procedure is as in example 4 except that vitamin E is not contained.
Product stability testing
Accelerated test method: the sterilized products for otitis externa prepared in 6 embodiments of the present invention were packaged, placed in a 37 ℃ incubator for 3 months, and the content of the bactericidal active ingredient in the sterilized products for otitis externa before and after the placement was measured.
Through determination, the content of benzalkonium bromide serving as an active ingredient in the disinfection products for otitis externa prepared in embodiments 1-6 of the invention is reduced by less than 1%. According to the regulations of the disinfection technical Specification (2002 edition), the results of the accelerated test method are evaluated: "if the sample is stored for 3 months at 37 ℃, the content reduction rate of the sterilization active ingredient is less than or equal to 10 percent, and the storage period can be determined as 2 years.
Product safety evaluation test
The product obtained in experimental example 4 of the present invention was subjected to a safety evaluation test, and the results thereof were as follows:
(1) mouse acute oral toxicity test: the disinfection product for otitis externa provided by the invention has an LD50 value of more than 5000mg/kg (body weight) in an oral test, and the toxicity is classified as actual non-toxic;
(2) mouse marrow pleochromocyte micronucleus test: the disinfection product for the otitis externa provided by the invention has no micronucleus-causing effect on mouse myeloadephagia pleochromocyte;
(3) multiple skin irritation tests: the disinfectant product for external otitis provided by the invention acts on rabbit damaged skin for 4 hours, the average value of the total integral is 0, the skin irritation index is less than 0.5, and the irritation strength belongs to the irritation property.
(4) Mucous membrane stimulation test: the disinfection product for the otitis externa provided by the invention has the mucous membrane stimulation index less than 1, the mucous membrane stimulation reaction intensity of 0 and stimulation intensity without irritation.
Clinical application
Clinical trials were conducted on the sterilized products for otitis externa prepared in example 4 and comparative examples 1 to 2, and patients were followed.
Patient inclusion criteria: 1. itching of the external auditory canal, swelling and stuffiness of the ear; 2. inspecting the external auditory meatus with grey white or smoky black villous or powdery substances in the deep part; 3. spores or hyphae can be seen after the picture culture of the secretion of the external auditory canal.
Clinical observations were made on 90 patients aged 25 to 53 years and having a course of 3.5 to 24 months diagnosed with inflammation of the external auditory meatus, wherein 37 patients were treated with the disinfectant product for external otitis prepared in example 4, 28 patients were treated with the product prepared in comparative example 1, and 25 patients were treated with the product prepared in comparative example 2. The treatment method comprises applying 2g of the composition to external auditory canal of patient 1 time a day for 15 days, and the statistical results of the therapeutic effects before and after administration are shown in Table 1 below:
TABLE 1 therapeutic effect of the disinfectant product for otitis externa of the present invention on otitis externa
Group of Symptoms and signs Selected cases Cure of disease Is effective Invalidation High efficiency
Example 4 Inflammation of external auditory canal 37 examples of 23 example(s) 12 examples of Example 2 94.6%
Comparative example 1 Inflammation of external auditory canal 28 examples of 11 examples of 9 examples of 8 examples of 71.4%
Comparative example 2 Inflammation of external auditory canal 25 examples of 9 examples of 10 examples of 6 examples of 76.0%
As can be seen from table 1, the disinfectant product for otitis externa provided in example 4 of the present invention has an obvious effect of controlling the state of illness and alleviating the symptoms of patients, has low irritation, has a high effective rate for treating otitis externa, and can better improve the medication compliance of patients. Comparative example 1 does not contain the oil of the artemisia pigweed, the treatment effective rate is only 71.4 percent, which shows that the artemisia pigweed oil and the benzalkonium bromide or the medicinal salt thereof have synergistic action, and the combination of the artemisia pigweed oil and the benzalkonium bromide can enhance the disinfection effect. The comparative example 2 does not contain vitamin E, the treatment effective rate is only 76.0%, and the vitamin E plays an important role in protecting the external auditory canal mucosa, treating inflammation, improving the external auditory canal environment and promoting the repair of the external auditory canal mucosa.
After the application of the medicine is finished, the fungus detection of the external auditory canal is carried out on 90 patients, and the detection results are shown in table 2:
TABLE 2 fungal negative conversion rate
Figure BDA0002952422440000061
Figure BDA0002952422440000071
As can be seen from Table 2, the disinfection product for otitis externa provided in example 4 of the present invention has a fungus turning negative rate of 78.4% after being used for treating patients with otitis externa. And the comparative example 1 does not contain the artemisia pigweed oil, the negative conversion rate of the fungus is only 64.3 percent, and the artemisia pigweed oil has the effect of long-term fungus inhibition. Comparative example 2 contains no vitamin E, and the negative conversion rate of the fungus was only 68.0%, indicating that vitamin E plays an important role in inhibiting the growth of the fungus.
The above description is only for the specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto, and other modifications or equivalent substitutions made by the technical solution of the present invention by the ordinary skilled in the art should be covered within the scope of the claims of the present invention without departing from the spirit and scope of the technical solution of the present invention.

Claims (9)

1. A disinfecting product for otitis externa, comprising the following active ingredients: (1) one of benzalkonium bromide, benzalkonium chloride and polyhexamethylene biguanide, or a pharmaceutically acceptable salt of any of the foregoing; (2) oil of Artemisia Sus Domestica; (3) and (3) vitamin E.
2. The disinfectant product for external otitis according to claim 1, wherein the oil of Artemisia Sus Domestica contains the following components: 1-phenyl-2, 4-pentadiyne, eugenol, hexa-2, 4-diynylbenzene, rutin enol, caryophyllene oxide, 2, 4-hexadiynylbenzophenone, spiro (9-methylenetricyclo [6.2.1.0(2,7) ] undecene-2, 4, 6-triene) -11,1' -cyclopropane.
3. A disinfecting product for otitis externa according to claim 1, comprising the following components in parts by mass: 0.01-0.2 part of benzalkonium bromide or medicinal salt thereof, 0.4-0.8 part of artemisia oil and 0.1-0.5 part of vitamin E.
4. A disinfecting product for external otitis according to claim 1, further comprising other adjuvants, said other adjuvants being one or more of glyceryl stearate, white petrolatum, lanolin, liquid paraffin, stearic acid, stearyl alcohol, sodium lauryl sulfate, polysorbate 80, glycerin, propylene glycol.
5. A disinfecting product for otitis externa according to claim 4, wherein the further adjuvant further comprises one or both of ethylparaben and propylparaben.
6. A disinfecting product for otitis externa according to claim 1, comprising the following components in parts by mass: 0.015 part of benzalkonium bromide or medicinal salt thereof, 0.5 part of artemisia pigweed oil, 0.5 part of vitamin E, 15-21 parts of glyceryl stearate, 20-30 parts of liquid paraffin, 6-11 parts of white vaseline, 2 parts of stearic acid, 6-12 parts of propylene glycol, 1-2 parts of sodium dodecyl sulfate, 0.02 part of ethylparaben and the balance of distilled water.
7. A disinfecting product for otitis externa according to claim 1, comprising the following components in parts by mass: 0.015 part of benzalkonium bromide or medicinal salt thereof, 0.5 part of artemisia pigweed oil, 0.5 part of vitamin E, 15 parts of glyceryl stearate, 20 parts of liquid paraffin, 10 parts of white vaseline, 2 parts of stearic acid, 10 parts of propylene glycol, 2 parts of sodium dodecyl sulfate, 0.02 part of ethylparaben and the balance of distilled water.
8. A method for preparing a disinfectant product for otitis externa comprising the steps of:
1) putting the glyceryl stearate, the white vaseline, the liquid paraffin and the stearic acid into a container, and heating and melting at 70-80 ℃ to obtain an oil phase;
2) adding propylene glycol, sodium dodecyl sulfate, ethylparaben, benzalkonium bromide, vitamin E and artemisia pigskin oil into distilled water, and heating to 70-80 ℃ to be used as a water phase;
3) adding the water phase into the oil phase under stirring, continuously stirring to cool to form emulsion matrix type ointment, and packaging in tubes to obtain the disinfectant product for treating otitis externa.
9. The external otitis disinfection product according to any of claims 1-8, wherein the external otitis disinfection product is prepared into an external otitis disinfection spray, an external auditory canal cleaning solution, an ear drop, an ointment or a paste, an external auditory canal disinfection gel, an earplug, or a solid external auditory canal disinfection preparation.
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CN103432584A (en) * 2013-08-14 2013-12-11 金红叶纸业集团有限公司 Cooling and itching relieving composition and paper towel employing same
WO2017083363A1 (en) * 2015-11-09 2017-05-18 Unigen, Inc. Natural preservatives and antimicrobial agents, including compositions thereof
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