EA044553B1 - DRUG FOR APPLICATION OF THE ORAL AND NOSE CAVITY AND METHOD OF ITS APPLICATION AS COMPOSITION OF COMPLEX THERAPY OF INFECTIOUS AND INFLAMMATORY DISEASES OF THE NASAL AND ORAL CAVITY - Google Patents

Description

The present invention relates to antiseptic oral care products. The invention can be used as an adjuvant for the prevention and as part of complex therapy for infectious and inflammatory diseases of the nasal and oral cavity, including colds and acute respiratory viral infections.

The closest analogue of the invention is an oral care product, known from patent RU 2581915, published on April 20, 2016. The composition has the following composition: a first component containing at least one compound that increases the oxidation-reduction potential in the oral cavity (Eh), selected from the group consisting of sodium chlorite, sodium bromite, hydrogen peroxide and combinations thereof, and pharmaceutically acceptable a carrier, and a second component containing at least one zinc compound, cetylpyridinium chloride (CPC) and a pharmaceutically acceptable carrier, wherein the first component contains from 0.01 to 3.0% by weight of at least one Eh-increasing compound, and where the second component contains from 0.02 to 1.0 wt.% zinc ion and from 0.02 to 0.6 wt.% CPC.

One particular embodiment of an oral care product disclosed in the prior art contains at least one additional component selected from the group consisting of a desensitizer, a whitening agent, an antimicrobial agent, an antibiotic, an anti-caries agent, an anti-plaque agent, an antitartar, soothing or reducing dry mouth, deodorant, polish, detergent and sweetener.

The deodorant includes at least one substance selected from chlorhexidine, hydrogen peroxide, vitamin B, vitamin C, sodium bicarbonate, medicinal herb, rue, and combinations thereof.

In another embodiment, the oral care product further comprises an antiviral agent. Suitable antiviral agents for use in an oral care product include, for example, abacavir, acyclovir, adefovir, dipivoxil, amantadine, amprenavir, ampligen, arbidol, atazanavir, atripla, boceprevir, cidofovir, combivir, darunavir, delavirdine, didanosine, docosanol, edoxudine, efavirenz, emtricitabine, enfuvirtide, entecavir, entry inhibitors, famciclovir, fixed-dose combination (antiretroviral), fomivirsen, fosamprenavir, foscarnet, phosphonet, hybridization inhibitor, ganciclovir, ibacitabine, imunovir, idoxuridine, imiquimod, indinavir, inosine, inhibitor integrases, type III interferon, type II interferon, type I interferon, interferon, lamivudine, lopinavir, loviride, maraviroc, morosidine, metisazone, nelfinavir, nevirapine, nexavir, nucleoside analogues (nucleoside analogue reverse transcriptase inhibitors), oseltamivir, peginterferon alfa-2a , pegylated interferon alfa, penciclovir, peramivir, pleconaril, podofilox, podophyllotoxin, protease inhibitor, pyramidin, raltegravir, reverse transcriptase inhibitor, ribavirin, rimantadine, ritonavir, saquinavir, stavudine, synergy enhancer (antiretroviral), tea tree oil, tenofovir, tenofovir disoproxil, tipranavir, trifluridine, trizivir, tromantadine, Truvada, valacyclovir, valganciclovir, vicriviroc, vidarabine, viramidine, zalcitabine, zanamivir and zidovudine.

In another embodiment, the oral care product further contains a sweetener that improves the taste of the oral care composition and freshens breath. Suitable sweeteners for use in an oral care product include, for example, xylitol, sodium saccharin, menthol, eucalyptus oil, sorbitol, mannitol, saccharin, aspartame, acesulfame potassium (acesulfame K), stevia, peppermint oil, spearmint oil, and their combinations.

The technical problem of the prototype is the overload of the composition of the product, characterized by the presence of antibiotics, antiviral and antimicrobial agents. This leads to excessive saturation of the product with a large number of ingredients, which are complex compounds, which together can have both positive and negative effects. In addition, the inclusion of one or another compound from the group of antibiotics or antiviral agents can lead to resistance of bacteria and viruses to them in the human body, who constantly uses this drug prophylactically.

This leads to a decrease in the body’s resistance to the effects of such infections in the future and reduces the effectiveness of their subsequent treatment with known means, and also contributes to the emergence of new mutated forms of bacteria and viruses for which effective treatments have not yet been developed. Overloading the composition can cause allergic reactions in the consumer.

In addition, the manufacture of a product that includes many components becomes complex and expensive.

On the other hand, the exclusion of active components may negatively affect the effectiveness of the product.

The objective of the present invention is to create an antiseptic that is easier to manufacture than the prototype and has high organoleptic properties, which is effective for the complex treatment or prevention of infectious and inflammatory diseases of the nasal or oral cavity when irrigating the mouth and nose, without causing allergic reactions.

The technical result of the invention is the creation of an antiseptic agent that is easier to manufacture than the prototype and has high organoleptic properties, which is effective for the complex treatment or prevention of infectious and inflammatory diseases of the nasal or oral cavity when irrigating the oral cavity and nose, without causing allergic reactions. reactions.

The specified technical result is achieved by creating a product for application to the mouth and nose, characterized by the fact that it contains chlorhexidine, glycerin, tea tree oil or extract, purified water and colloidal silver or Ag ⁺ silver ions, in the following ratio of components, wt.%:

Colloidal silver or silver ions Ag ⁺ - 0.04-0.06

Chlorhexidine bigluconate solution 20% - 0.04-0.12

Glycerin - 13-17

Tea tree oil or tea tree extract - 0.02-0.04

Purified water up to 100

In some embodiments, the product may include glycerol in an amount of 13-17 wt.% instead of glycerin and additionally include sodium saccharin in an amount of from 0.01 to 0.03 wt.%, acting as a sweetener.

The subject of the invention is also the use of the claimed product as part of complex therapy for infectious and inflammatory diseases of the nasal and oral cavity, characterized by the fact that the oral and nasal mucosa are irrigated for preventive or therapeutic purposes, 3 sprays 3 times a day for 7-10 days.

Carrying out the invention

The claimed product for application to the oral and nasal cavity includes components in the following ratio, wt.%:

Colloidal silver or silver ions Ag ⁺ - 0.04-0.06

Chlorhexidine bigluconate solution 20% - 0.04-0.12

Glycerin - 13-17

Tea tree oil or extract - 0.02-0.04

Purified water up to 100.

The product may also include glycerol in an amount of 13-17 wt.% instead of glycerin and additionally include sodium saccharin, which acts as a sweetener, in an amount from 0.01 to 0.03 wt.%.

The claimed product can be used in the treatment or prevention of diseases of the oral cavity by applying it to the oral cavity.

The application or application of a product means its interaction with the oral or nasal cavity through rinsing, irrigation or other interaction.

Irrigation of the oral and nasal cavities is usually carried out using a spray dispenser.

The agent according to the invention may contain 0.04-0.05 wt.% colloidal silver or silver ions Ag ⁺ .

The agent according to the invention may contain 0.05-0.06 wt.% colloidal silver or silver ions Ag ⁺ .

The product according to the invention may contain chlorhexidine bigluconate solution 20% 0.04-0.05 wt.%.

The product according to the invention may contain chlorhexidine bigluconate solution 20% 0.04-0.06 wt.%.

The product according to the invention may contain chlorhexidine bigluconate solution 20% 0.04-0.07 wt.%.

The product according to the invention may contain chlorhexidine bigluconate solution 20% 0.04-0.08 wt.%.

The product according to the invention may contain chlorhexidine bigluconate solution 20% 0.04-0.09 wt.%.

The product according to the invention may contain chlorhexidine bigluconate solution 20% 0.04-0.10 wt.%.

The product according to the invention may contain chlorhexidine digluconate solution 20% 0.04-0.11 wt.%.

The product according to the invention may contain chlorhexidine bigluconate solution 20% 0.04-0.12 wt.%.

The product according to the invention may contain chlorhexidine bigluconate solution 20% 0.06-0.07 wt.%.

The product according to the invention may contain chlorhexidine digluconate solution 20% 0.06-0.08 wt.%.

The product according to the invention may contain chlorhexidine digluconate solution 20% 0.06-0.09 wt.%.

The product according to the invention may contain chlorhexidine bigluconate solution 20% 0.06-0.10 wt.%.

The product according to the invention may contain chlorhexidine bigluconate solution 20% 0.06-0.11 wt.%.

The product according to the invention may contain chlorhexidine bigluconate solution 20% 0.06-0.12 wt.%.

The product according to the invention may contain chlorhexidine bigluconate solution 20% 0.08-0.10 wt.%.

The product according to the invention may contain chlorhexidine bigluconate solution 20% 0.08-0.11 wt.%.

The product according to the invention may contain chlorhexidine bigluconate solution 20% 0.08-0.12 wt.%.

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The claimed remedy is effective in the treatment or prevention of the following diseases: acute respiratory viral diseases, acute and chronic diseases of the ENT organs of bacterial etiology, chronic diseases of the ENT organs in the acute stage, but is not limited to them.

The claimed product is effective in the treatment or prevention of diseases of the oral mucosa and throat, such as tonsillitis, tonsillitis, laryngitis, pharyngitis, aphthous and ulcerative stomatitis, and bleeding gums.

The claimed remedy is effective in the treatment and prevention of acute respiratory viral infections and influenza.

The product can be used in preparation for operations and postoperative treatment of the oral cavity, treatment of the oropharynx for the prevention of ventilator-associated pneumonia.

The claimed product is effective in the treatment or prevention of periodontal disease, plaque, caries, gingivitis, glossitis.

The claimed product is suitable for the complex treatment of infectious and inflammatory diseases of the nasal and oral cavities.

The claimed product is also used in the care of the oral and nasal cavities.

A specific variant of the agent according to the invention can be obtained, for example, as follows.

Option 1. Components: colloidal silver - 0.05 g, chlorhexidine digluconate solution 20% - 0.1 ml, glycerin - 15 g, tea tree oil - 0.03 g, purified water up to 100 ml.

The calculated amount of purified water is loaded into mixer No. 2. Then, with constant stirring, add the calculated amount of chlorhexidine bigluconate and colloidal silver concentrate. Stir for 10-15 minutes until the main components are completely dissolved.

The calculated amount of glycerin and tea tree oil are added to intermediate container No. 1. Then, gradually, with constant stirring, add the contents of intermediate container No. 1 to mixer No. 2. Stir for 5-10 minutes. Next, turn on the rotary pump and, with constant stirring, pass the entire solution according to the mixer-pump-mixer scheme for 25-30 minutes.

Option 2. Components: colloidal silver - 0.05 g, chlorhexidine bigluconate solution 20% - 0.1 ml, glycerin - 15 g, tea tree oil - 0.03 g, purified water up to 100 ml.

The calculated amount of purified water and glycerin is loaded into mixer No. 2. Then, with constant stirring, add the calculated amount of chlorhexidine bigluconate and colloidal silver concentrate. Stir for 10-15 minutes until the main components are completely dissolved.

Add the calculated amount of tea tree oil to intermediate container No. 1. Then, gradually, with constant stirring, add the contents of intermediate container No. 1 to mixer No. 2. Stir for 5-10 minutes. Next, turn on the rotary pump and, with constant stirring, pass the entire solution according to the mixer-pump-mixer scheme for 25-30 minutes.

The colloidal silver used in the invention may be silver in molecular or ionized form.

The source of colloidal silver, in those embodiments where it is used, may be, for example, the colloidal silver concentrate KND-S-K or the colloidal substance concentrate Argovit-BIO, but is not limited to them.

As colloidal silver, in those embodiments where it is used, you can also use a concentrate of colloidal nanosilver AgBion-2 [http://rps61.ru/good/65].

When replacing colloidal silver with silver ions, the resulting solution is ionized with silver ions Ag ⁺ to a level of 50 mg/l of the mixture.

Glycerin is used in the solution to soften the skin and treat the mucous membrane, which, when inflamed, is more dense and has less effective absorption. In addition, glycerin lowers blood pressure in the tissues of the mouth and nose, which ensures better blood circulation and reduces tissue inflammation.

Chlorhexidine is an antiseptic. As part of the drug, it is used to disinfect mucous membranes from viruses and bacteria. The duration of exposure to the affected areas reaches 4 hours.

Bigluconate is a substance that forms the base of chlorhexidine. It is classified as a cationic biguanide. The substance penetrates the cell membrane and is fixed on the bacterial cytoplasm, blocking their access to oxygen. This is what leads to the death of bacteria. Additionally, bigluconate can destroy bacterial DNA and disrupt synthesis processes.

The main properties of tea tree oil and extract are: antiseptic; antifungal; weak pain reliever due to its cooling and distracting effect; antidepressant (helps fight phobias and insecurity); stimulating (improves performance, promotes wound healing); immunostimulating. Its effectiveness has been proven in the treatment of sore throat, influenza, ARVI and colds. It is also effective against herpes.

Due to its low calorie content due to the absence of sodium carbohydrates, saccharin is used in the drug solution instead of sugar in order to give the drug a normal taste in order to eliminate the rejection effect in some people and children, and also successfully replaces natural sugar for those suffering from diabetes (does not provoke insulin surges) or aspiring lose weight.

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Another advantage of saccharin is the fact that it is practically not absorbed by the body and is excreted unchanged, which allows it to be used in a preparation without fear of allergies from its use.

Silver in the claimed product plays an important role - on the one hand, as an antiseptic, and on the other, as a transporter of the components of the drug through the mucous membrane of the oral cavity and nose.

Silver is unique in that it kills about 650 different pathogens of all major types: bacteria; mushrooms and yeast; viruses; protozoa. 95% of herpes virus strains are sensitive to silver. The wide spectrum of antimicrobial action of silver, the lack of resistance to it in most pathogenic microorganisms, low toxicity, lack of allergenicity, and good tolerability contribute to increased interest in its use.

The bactericidal effect of silver is much broader than many antibiotics and sulfonamides. It is known that silver has a more powerful antimicrobial effect than penicillin, biomycin and other antibiotics, and has an effect on antibiotic-resistant strains of bacteria. Silver ions have different effects on Staphylococcus aureus, Proteus, Pseudomonas aeruginosa and Escherichia coli - from bacteriostatic (inhibition of reproduction) to bactericidal (killing microbes). In relation to Staphylococcus aureus and many cocci, it sometimes significantly exceeds the effect of antibiotics. It has been established that silver ions have a pronounced ability to inactivate vaccinia viruses, influenza strains A1, B, some entero- and adenoviruses, as well as block HIV and have a good therapeutic effect in the treatment of Marburg virus disease, viral enteritis and distemper in dogs. Pathogenic microflora is more sensitive to silver ions than non-pathogenic microflora.

Chlorhexidine is ineffective against acid-fast bacteria or bacterial spores. Therefore, adding colloidal silver to the solution or saturating the solution with silver ions, which are able to bind acid-resistant bacteria and bacterial spores, which increases the therapeutic effect of the drug as a whole.

It is known that leukocytes absorb silver and deliver it to the site of infection. And under the influence of silver, inflammation is relieved: metal and proteins form special compounds that can neutralize the effect of most pathogenic microbes. Moreover, these compounds can have a regenerating effect on tissues. Actually, this explains the beneficial effect of silver on any inflammation.

The active healing element of silver is its ions - Ag ⁺ . Silver ions easily interact with other ions, forming, as a rule, insoluble or poorly soluble compounds, which prevents the penetration of silver into a living organism. For example, silver ions easily combine with chlorine anions, resulting in the formation of slightly soluble silver chloride.

However, in aqueous solution, silver ions retain their activity due to their stable stabilization in the form of hydrated silver. This is due to the property of a bipolar water molecule to form hydrogen bonds, as a result of which water molecules in the form of a shell can shield anions and cations from mutual influence.

In fact, fragments of a water molecule form a fairly stable shell around the silver ion, keeping this ion in a free and active state. Therefore, even when entering the intestines, stabilized hydrated silver is not noticeably affected by chlorine ions and safely penetrates the body.

Silver ions also easily penetrate into the skin tissue under the protection of water molecules. Circulating in the bloodstream and liquid tissue media, hydrated silver ions easily penetrate pathogenic microbes, viruses and fungi through their outer shell, and then combine with the respiratory enzyme and, blocking the respiratory function, lead to their death. At the same time, pathogenic microorganisms cannot develop resistance to the destructive effects of silver ions, as they do in relation to antibiotics.

The drug Colloidal silver is known in the form of an ionized solution in a 60 ml bottle, which consists of an active component: colloidal silver in the form of an ionized solution, intended for internal and external use (Latin name: Silver colloidal, active ingredient: Colloidal silver (Silver colloidal), manufacturer : Nittany Pharmaceuticals/Vitaline, Nature's Sunshine Products (USA), Coral club (Germany).The drug is used in the treatment of rheumatoid arthritis.The proportion of pure silver in the colloidal solution depends on the percentage composition.

A disadvantage that appears when using this drug is the possibility of developing allergic reactions.

According to the World Health Organization, the ability to reliably kill certain bacteria is observed at concentrations of silver ions above 150 μg/l, and at lower concentrations they only inhibit the proliferation of bacteria.

Therefore, the use of colloidal silver also has a clinical effect only when the toxic dose of silver exceeds 50-60 μg/l.

Metallic silver is the least toxic. Poorly soluble silver salts (for example, chloride) are slightly toxic, but also inactive in terms of bactericidal activity.

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All of the above-described oral preparations containing silver have antibacterial activity, but also have technical problems: the difficulty of delivering effective doses of metallic silver to the site of infection.

In addition, silver-based preparations do not have anti-inflammatory activity and do not have the effect of normalizing the metabolic processes of protein substances in the body, which are often disrupted in infectious diseases of the oral and nasal cavity.

In the study Injections of silver nanoparticles are deadly for mammals [http://popnano.ru/news/show/2914], published: 04/23/2010, it was found that an aqueous solution of silver nanoparticles, which has bactericidal and antiviral properties and is widely used in industry, is harmful to mammals if administered by injection. The initial concentration of nanoparticles in the aqueous solution was 0.54 g/L. The effect of the solution was compared with the effect of Ag ⁺ ions in equivalent concentrations, for which a solution of silver nitrate was used (initial concentration 0.85 g/l). Young experimental mice that were injected with silver solutions in different forms and concentrations were divided into several groups. The animals were kept in a vivarium for 30 days, where scientists monitored their condition and kept a daily record of the dead. In the first hours after injection, rodents injected with nanoparticles experienced decreased motor activity, seizures, and paralysis of the hind legs. Death occurred 12-24 hours after drug administration. Experts suggested that the animals were killed by the effect of the nanodrug on the nervous tissue. The rodents that were injected with silver ions remained fully alive, as did the control group that was injected with distilled water. Scientists assessed the toxic effect of nanoparticles on genetic material by the number of pathologically altered sperm in male mice and the degree of DNA damage in lymphocytes and other spleen cells. The damaging effect has been reliably proven.

Thus, the use of molecular colloidal silver is possible in tablets, capsules, ointments, creams and other non-injectable preparations.

Injectable forms typically use colloidal silver in the form of Ag ⁺ ions because it is safer.

A variant of the oral and nasal irrigator intended for use by children can be made in the form of a solution containing colloidal silver in the form of ions.

In the laboratory of virology of Kyiv State University, research was carried out to study the physiological effect of silver

[see: http:// www.nanonewsnet.ru/blog/nikst/fiziologicheskoe-vozdeistvie-nanochastits-serebra-na-organizmcheloveka].

It has been established that already doses of silver are 50; 200 and 1250 µg/l have a beneficial effect on experimental animals. Rats that drank water containing silver ions gained weight and developed faster than animals in the control group. Using spectral analysis, 20 μg of silver per 100 g of dry weight was detected in the liver of experimental animals, which corresponded to the normal silver content in the liver of rats. These studies have proven that doses of silver of 50-250 mcg/l are physiological and do not have harmful effects on the body with long-term use.

Academician L.A. made a great contribution to the study of the antimicrobial properties of silver water and its use for the disinfection of drinking water and food products. Kulsky

[see: http://www.nanonewsnet.ru/blog/nikst/fiziologicheskoe-vozdeistvie-nanochastits-serebra-na-organizmcheloveka].

His experiments, and later the work of other researchers, proved that it is metal ions and their dissociated compounds (substances that can disintegrate into ions in water) that cause the death of microorganisms. In all cases, with a bactericidal effect, the higher the concentration of silver ions, the greater the degree of activity of silver.

Today, science has proven that silver in ionic form has bactericidal, antiviral, pronounced antifungal and antiseptic effects and serves as a highly effective disinfectant against pathogenic microorganisms that cause acute infections.

On the surface of the epidermis, silver ions will have time to neutralize a small amount of bacteria, but they will not be able to overcome the transepidermal barrier and completely destroy foci of infection. In order for silver ions to enter the dermis, you need to use such an amount of product that will have a negative effect on the body and can lead to argyrosis [see: http://evolutsilver.m/blog/nanochasticy-i-iony/].

The situation with colloidal silver nanoparticles is different - they do not tend to combine with other substances, since they do not have an imbalance in the number of electrons, which means they do not lose their activity for a long time and can have a beneficial effect longer.

Nanosilver easily penetrates the inner layers of the skin and has a strong antibacterial effect precisely due to its size. Plus, the nanoparticle is coated with substances related to sebum. The skin absorbs certain substances well from the surface, and if the particle is coated with these substances, then it is absorbed into the skin even better [see: http://evolutsilver.ru/blog/nanochasticy-i-iony/].

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Another difference between silver ions and nanoparticles is the mechanism of action on bacteria.

Ions act on the principle of inhibiting the vital function of bacteria. Penetrating inside, they act as toxins, poison it, thereby causing death, they block the channels through which the bacteria feed, with the help of which it carries out its vital functions. In the process of destroying bacteria in this way, a very large number of ions are consumed, so products with ions give a short-term and incomplete effect, since it is impossible to provide the required number of ions in the dermis constantly and in the required quantity [see: http://evolutsilver.ru/blog/ nanochasticy-i-iony/].

In this regard, the use of silver ions is effective to achieve a quick local effect, which is achieved precisely by irrigating the mouth and nose.

The nanoparticle acts differently; it destroys the cell wall of the bacterium, causing its instant death from physical destruction, and not from poisoning with a toxin. The bacterium disintegrates and dies, and the nanoparticle is able to continue functioning. This way of destroying the bacterium does not leave it the opportunity to adapt, develop a defense mechanism and pass it on to next generations.

For this reason, the same concentrations of silver ions and silver nanoparticles give the same effect when applied locally by irrigating the mouth and nose.

In this connection, the use of metallic and colloidal silver for irrigation of the oral cavity and nose turned out to be effective at the same minimum doses in the solution of the claimed product as the use of silver ions in it.

The upper limit of the dosage of silver ions in the solution for injection was taken based on the results of studies (see above [http://popnano.ru/news/show/2914]), according to which injections of silver ion concentrations Ag ⁺ with values of 0 were considered safe .85 g/l.

The advantage of using silver nanoparticles compared to ions in a drug solution is that the surface coating on the nanoparticle is, on the one hand, protective, and on the other hand, can act as a platform for the transfer of various active substances [see: http://evolutsilver. ru/blog/nanochasticy-i-iony/]. Consequently, on the surface of nanoparticles, very important elements can be carried through the oral and nasal mucosa, also included in the composition of the drug solution, which carry out the main therapeutic function of the antiseptic. Nanoparticles specifically saturate the mucous membrane with the necessary substances without affecting other organs and tissues; therefore, they enhance the delivery of the entire complex of other components of the drug to the problematic inflamed area, which in turn ensures more effective regeneration of the mucous membrane of the mouth and nose.

The nanoparticle can remain on the surface of the skin for a long time; the ion is incapable of this, since it is very susceptible to ultraviolet radiation (sunlight). But, since the mucous membranes of the mouth and nose are not subject to this effect, and their influence is localized more densely per unit area of the mucosa, the effectiveness of silver ions in comparison with nanoparticles of colloidal and metallic silver turned out to be no less.

It is known that for humans, a toxic dose of silver when administered orally is a dose of 0.05-0.06 mg/l.

The upper dose limit for metallic or colloidal silver has been studied up to 0.2 mg/kg (0.2 mg/L), which is the upper concentration for drinking by astronauts.

But, since no more than 1-3 ml of the solution used for irrigation remains in the human body when irrigating the mouth and nose, the total percentage of the solution that penetrates the human body does not exceed 3%.

Thus, the maximum amount of silver in the claimed product - 0.06 mg per 100 g - is determined in such a way that, taking into account the fact that when using a solution and penetrating it into the human body, it does not exceed 3% per single use, that is, no more than 0.018 mg /kg, was sufficient to exhibit a therapeutic effect, at the same time, was below the limits of the upper permissible concentration.

When using the claimed product for irrigating the mouth and nose, it is recommended to carry out 3 sprays 3 times a day for adults and children over 14 years of age for 7-10 days.

When using the stated mouthwash, it is recommended to measure 10-40 ml of the product into a measuring cup and rinse the mouth vigorously for 1-3 minutes without swallowing. It is recommended to perform the procedure 2-4 times/day. The recommended course is 7-10 days.

The course of use can be extended up to 3 weeks on the recommendation of a doctor.

The resulting product was used for application to the oral and nasal mucosa for preventive and therapeutic purposes.

Using the proposed remedy, it is proposed to implement a method for the treatment or prevention of infectious and inflammatory diseases of the nasal and oral cavity. It is proposed to implement the method of irrigating the oral and nasal mucosa with the product by 3-5 sprays 2-4 times a day for 5-10 days using an inhaler. The inhaler can be any of those widely used in the area. The method can be carried out by irrigating the oral and nasal mucosa with 3 sprays from an inhaler 3 times a day for 7-9 days.

Using the proposed remedy, it is proposed to implement a method of treating or preventing infectious and inflammatory diseases of the nasal and oral cavity. It is proposed to implement the method by rinsing the oral and nasal mucosa for 1-3 minutes, 2-4 times a day for 7-9 days.

The present invention is supported by the following examples. These examples are not limiting, but are illustrative.

Example 1.

We used a product based on colloidal silver with the following composition.

Colloidal silver concentrate “KND-S-K” - 0.025 ml

Chlorhexidine bigluconate solution 20% - 0.05 ml

Glycerin - 7.5 ml

Tea tree oil - 0.015 ml

Purified water up to 50 ml

Prophylaxis was administered to 25 men and 25 women aged 25 to 55 years, suffering from frequent respiratory diseases, up to 4-6 episodes per year.

Prevention was carried out by irrigating the oropharynx with 3 sprays 3 times a day for 10 days.

The comparison group consisted of 25 men and 25 women of the same age with similar problems, who were given oropharyngeal irrigation with the following composition with the same frequency and frequency.

Chlorine hexidine bigluconate solution 20% - 0.06 ml

Glycerin - 7.5 ml

Tea tree oil - 0.015 ml

Purified water up to 50 ml

The control group received nothing.

Treatment results were assessed according to clinical research methods over time: examination of the nasopharynx, collection of anamnesis of life and illness, frequency, form and severity of colds, general blood test.

In 80% of those observed in all groups, at the first examination, signs of hyperemia of the pharynx or arches of the tonsils were revealed, 78% - signs of subatrophy of the mucous membrane of the posterior pharyngeal wall, 30% - hypertrophy of the tonsils from 1 to 3 degrees, 52% - single hypertrophied follicles on the posterior wall of the pharynx, In 5% of patients, thick white contents were found in the lacunae of the tonsils.

The general blood test revealed no significant abnormalities.

Research results.

Irrigation of the oral cavity and nose was carried out with 3 sprays 3 times a day for 10 days, this made it possible to obtain a lasting therapeutic effect in a short period of time (4-5 days in the main group versus 9-14 days in the control group). Clinical improvement was confirmed by positive dynamics of changes in clinical indices.

During the six-month follow-up period, no colds were noted in the main group. Upon examination, a decrease in the severity of hyperemia of the pharynx was noted in 75% of patients who received irrigation with the study drug; a decrease in follicular hyperplasia was detected in 85% of those observed. Residual hyperemia was mainly observed only in the area of the tonsil arches; the nasopharyngeal mucosa was of normal, pink color. No significant abnormalities were found in blood tests.

In the control group, 1-2 months after the start of observation, 34% of the subjects had episodes of acute respiratory diseases, accompanied by increased hyperemia of the nasopharyngeal mucosa, an increase in temperature to subfebrile and a deterioration in general condition. In 25% without visible manifestations of ARVI, negative dynamics were revealed when examining the nasopharynx: severe diffuse hyperemia of the mucous membrane, multiple enlarged follicles on the posterior wall of the pharynx. All of these signs were accompanied by patient complaints of soreness and pain when swallowing.

In the comparison group, 15% had episodes of acute respiratory diseases already 2 months after the end of therapy, 12% of those observed noted a periodic deterioration in health without a rise in temperature and general manifestations of intoxication, accompanied by a sore throat and discomfort when swallowing. During examination, all patients had diffuse hyperemia of the mucous membrane and arches of the tonsils, single or multiple hypertrophied follicles on the posterior wall of the pharynx.

In all groups during the observation period, no significant deviations in blood tests were detected.

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Example 2.

We used a product saturated with silver ions Ag ⁺ of the following composition.

Colloidal silver concentrate “KND-S-K” - 0.06 ml

Chlorhexidine bigluconate solution 20% - 0.12 ml

Glycerin - 17 ml

Tea tree extract - 0.04 ml

Purified water up to 100 ml

Prophylaxis was administered to (30 children aged 7 to 18 years) suffering from frequent respiratory diseases, up to 4-6 episodes of ARVI per year.

Prevention was carried out by irrigation with 3 sprays 3 times a day for 7 days.

The control group was a group of 30 children of the same age with similar problems; those observed in this group did not receive any therapy.

The comparison group received a drug that did not contain silver.

Chlorhexidine bigluconate solution 20% - 0.18 ml

Glycerin - 17 ml

Tea tree extract - 0.04 ml

Purified water up to 100 ml

The results of treatment were assessed according to clinical research methods over time: examination of the nasopharynx, collection of anamnesis of life and disease, general blood test. The organoleptic properties of the product were also assessed, since children took part in the study.

Research results.

Irrigation of the oral and nasal cavity with 3 sprays 3 times a day for 7 days made it possible to obtain a lasting therapeutic effect in a shorter period of time (6-7 days in the main group versus 11-17 days in the comparison group). Clinical improvement was confirmed by positive dynamics of changes in clinical indices.

Thus, during the initial examination of the children of the main group, 85% showed signs of hypertrophy of the tonsils and proliferation of adenoid tissue of grade 1-3, 48% had mild hyperemia of the mucous membrane of the oropharynx, tonsils and their arches, 12% noted recurrent mucous or mucopurulent nasal discharge; in 7%, mucopurulent discharge was detected in the lacunae of the tonsils and the crypts of the adenoid tissue. All the subjects (or their representatives) noted that the subjects suffered up to 4-6 episodes of ARVI per year. Blood tests revealed no significant changes.

During the two-month follow-up period, no colds were noted in the main group. All observed patients noted a decrease in the amount of nasal discharge; in two patients with severe hypertrophy of the adenoid tissue, the discharge remained, but acquired a mucous character, and the amount of discharge decreased significantly. In the control group, 55% of the subjects developed colds within 3-4 weeks after the start of observation. The episodes were accompanied by a deterioration in the general condition, a rise in temperature to subfebrile levels, mucous or mucopurulent discharge from the nose, and diffuse hyperemia of the oro- and nasopharynx.

In the comparison group, after 3-5 weeks, 27% of those observed had episodes of ARVI, accompanied by classic symptoms. In the remaining patients, in most cases, the changes identified during the first examination remained. Positive dynamics in the form of a decrease in hyperemia and a decrease in discharge were demonstrated by about 15% of those observed.

In all groups, no significant changes in blood tests were detected during the observation period.

The overall effectiveness of treatment is also influenced by the organoleptic properties of the drug, aimed at course use, since they determine the patient’s adherence to treatment. Especially, high organoleptic properties are important for patients - children.

When assessing the organoleptic properties of the claimed product, surveys of children were conducted. 26 children rated the taste and smell of the product as pleasant and wanted to continue treatment with it. 4 have a neutral attitude.

Example 3.

Patient I., 18 years old, complained of a sore throat that occurs regularly in the autumn-winter-spring period, often developing into a cold, accompanied by a deterioration in general condition and a rise in temperature, which is periodically complicated by obstructive bronchitis.

Objectively: the oral mucosa is subatrophic, hyperemic, edematous, pinpoint hemorrhages are detected in the tonsils, single hypertrophied follicles on the posterior wall

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Diagnosis: exacerbation of chronic pharyngitis.

The patient is recommended to measure 30 ml into a measuring cup and gargle intensively for 1-3 minutes, without swallowing, 3 times a day for 10 days.

The following composition was used.

Colloidal silver concentrate “KND-S-K” - 0.02 ml

Chlorhexidine bigluconate solution 20% - 0.04 ml

Glycerin - 6.5 ml

Tea tree oil - 0.01 ml

Purified water up to 50 ml

Next visit: already on the fifth day after using the developed product, the patient noted a significant decrease in pain and burning in the throat.

A week later, upon objective examination, swelling and hyperemia of the mucous membrane decreased, hemorrhages in the tonsil area and follicular hypertrophy were absent.

A month later, the patient’s sore throat disappeared, and colds did not occur for more than six months.

The results obtained indicate complete relief of the inflammatory process, the wound-healing effect of the drug, and a decrease in the virulence of oral microorganisms.

Example 4.

Patient K., 37 years old, complained of constant colds, accompanied by nasal congestion, a prolonged runny nose with profuse yellowish discharge, a dry cough and a feeling of dry nasopharynx, partial loss of smell, fatigue and loss of appetite; a puncture of the nasal sinus and examination of the contents revealed streptococcus .

Objectively: the nasopharynx is swollen, there is yellowish purulent discharge in the middle meatus on the right and on the posterior wall of the pharynx, pain in the projection of the anterior wall of the maxillary sinus on the right. An x-ray of the paranasal sinuses reveals thickening of the mucous membrane in the projection of both maxillary sinuses, and the fluid level on the right. Deviation of the nasal septum. Frontal and main sinuses without pathological changes.

Diagnosis: chronic right-sided sinusitis in the acute stage.

The patient underwent 5 punctures of the maxillary sinus (including a diagnostic one); after a course of antibiotic treatment, irrigation of the oral and nasal cavity with 3 sprays 3 times a day for 10 days was recommended.

The following composition was used for irrigation.

Colloidal silver concentrate “KND-S-K” - 0.025 ml

Chlorhexidine bigluconate solution 20% - 0.05 ml

Glycerol - 7.5 ml

Tea tree extract - 0.015 ml

Purified water up to 50 ml

A week later, upon objective examination, the swelling of the nasopharynx decreased, the cough stopped, and appetite and sense of smell were restored.

After 15 days, the patient’s runny nose completely stopped, her nasal passages were clean and there was no discharge, and new episodes of the disease did not occur for more than 3 months.

The results obtained indicate complete relief of the inflammatory process as part of complex therapy, the wound-healing effect of the drug, and a decrease in the virulence of oral microorganisms.

Example 5.

Patient Yu., 25 years old, complained of regularly expressed symptoms of a cold: elevated body temperature, weakness, sore throat, aggravated by swallowing, heaviness in the head, bad breath. After almost every cold there are complications in the form of a sore throat.

Objectively: there is an increase and tenderness of the submandibular lymph nodes, grade 2 hypertrophy of the tonsils, the mucous membrane is uniformly hyperemic, multiple adhesions of the tonsils and arches, purulent contents in the lacunae of the tonsils.

In a clinical blood test, changes are typical for the inflammatory process.

Diagnosis: chronic tonsillitis, exacerbation. Tonsil hypertrophy 2nd degree

The patient is recommended to measure 30 ml into a measuring cup and gargle intensively for 1-3 minutes, without swallowing, 3 times a day for 10 days.

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The following composition was used.

Colloidal silver concentrate “KND-S-K” - 0.02 ml

Chlorhexidine bigluconate solution 20% - 0.04 ml

Glycerol - 6.5 ml

Tea tree extract - 0.01 ml

Purified water up to 50 ml

A week later, upon objective examination, purulent contents in the lacunae of the tonsils are not detected, the submandibular lymph nodes are not enlarged, and there is no pain on palpation of the lymph nodes. Sore throat has decreased.

After 12 days, the patient’s sore throat completely stopped, new episodes of the disease did not occur for more than 4 months.

The experiments conducted indicate complete relief of the inflammatory process, the wound-healing effect of the product, and a decrease in the virulence of oral microorganisms.

The research results showed that the developed product is highly effective when irrigating the oral and nasal cavity as an adjuvant for the prevention and as part of complex therapy for infectious and inflammatory diseases of the nasal and oral cavity, including colds and acute respiratory viral infections.

The product of the claimed composition ensures the delivery of effective doses of metallic silver to the site of infection without causing allergic manifestations. The use of the proposed remedy allows one to safely obtain the required therapeutic effect in various age groups of patients.

The proposed antiseptic agent for irrigation of the oral cavity, characterized by the quantitative and qualitative composition of the components, is simpler to manufacture compared to the prototype, effective as a prophylactic agent and as part of complex therapy for infectious and inflammatory diseases of the nasal and oral cavity, does not cause the body's resistance to the effects infections.

The proposed means for obtaining a ready-to-use drug is placed in standard inhaler devices using standard, for example, industrial technology. The finished product thus obtained is intended for treatment or prevention by spraying into the oral or nasal cavity and is administered through this inhaler.

Claims (8)

1. A product for application to the oral and nasal cavity, characterized in that it contains chlorhexidine, glycerin, tea tree oil or extract, purified water and colloidal silver or Ag ⁺ silver ions, in the following ratio of components, wt.%: colloidal silver or silver ions Ag ⁺ - 0.04-0.06; chlorhexidine bigluconate solution 20% - 0.04-0.12; glycerin - 13-17; tea tree oil or tea tree extract - 0.02-0.04; purified water - up to 100. 2. The product according to claim 1, characterized in that it contains chlorhexidine bigluconate, solution 20% - 0.05-0.08. 3. The product according to claim 1, characterized in that it contains chlorhexidine bigluconate, solution 20% - 0.08-0.12. 4. The product according to claims 1-3, additionally including sodium saccharin in an amount of 0.01 to 0.03 wt.%. 5. A product according to claims 1-4, where the application is an irrigation or rinsing. 6. Use of a product according to claims 1-5 for the treatment or prevention of infectious and inflammatory diseases of the nasal and oral cavity. 7. Application according to claim 6, characterized in that the application is carried out as part of complex therapy. 8. A method for the treatment or prevention of infectious and inflammatory diseases of the nasal and oral cavity, characterized in that the agent according to claims 1-5 is applied to the mucous cavity 2-4 times a day for 5-10 days.