RU2297840C1 - Copper-silver-containing antibacterial agent for otitis prophylaxis and treatment - Google Patents

Abstract

FIELD: medicine, otorhinolaryngology, pharmaceutical industry.

SUBSTANCE: invention proposes an antibacterial agent containing copper acetate, silver nitrate, polyethylene glycol and water taken in the definite amounts. Agent possesses the enhanced antibacterial effect and effective in prophylaxis and treatment of otitis.

EFFECT: proposed agent is used as an antibacterial agent for prophylaxis and treatment of otitis.

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Description

The invention relates to medicine, namely to the creation of antimicrobial agents with the possibility of their use in otorhinolaryngology for the prevention and treatment of otitis media.

Well-known means and methods of treatment of otitis media of the external auditory canal using ointments containing antibiotics [1, p. 75]. Despite their high effectiveness, complications are frequent, the causes of which may be: allergic reactions to an antibiotic, the appearance of resistant strains of pathogenic microflora, insufficient spectrum of antibiotic action on a particular microorganism. As a result, the treatment process is delayed, the disease can go into an intractable chronic form.

Often, external otitis is associated with professional activities, for example: submariners, divers, pilots, workers in workshops containing a humid and aggressive atmosphere.

The search for funds without contraindications for the treatment and prevention of otitis media is relevant.

Known therapeutic and preventive solution based on water, containing copper and silver ions at their combined concentration of up to 0.6 mg% [2]. Known solution has a wide spectrum of antimicrobial activity and does not cause the appearance of resistant strains.

A disadvantage of the known solution in its low antibacterial effectiveness: the solution inhibits pathogenic microorganisms at a concentration of not more than 100,000 CFU / 1 ml.

Known therapeutic agent with antimicrobial action [3] based on physiological saline (prototype). The product contains copper ions from 6.0 to 24.0 mg / L and silver ions from 0.0001 to 0.0048 mg / L. The tool was tested in the treatment of ENT diseases, had no contraindications and was not inferior to standard antibiotics in its effectiveness.

A disadvantage of the known means is its high fluidity, which does not allow fixing it for a long time in the focus of the disease.

The wide antimicrobial spectrum of action of drugs containing copper and silver, their lack of contraindications prompt specialists to improve copper-silver-containing drugs to solve particular problems of therapy.

The present invention was the creation of a tool containing copper and silver, for the prevention of external otitis without the disadvantages inherent in previously known means.

To solve this problem, polyethylene glycol was chosen as the basis of the antimicrobial agent, which is widely used in pharmacy for the preparation of such drugs.

The introduction of copper and silver ions into polyethylene glycol by means of electrochemical processes is not possible due to the very low conductivity of the base and the possibility of the formation of new compounds due to secondary reactions.

Salts were chosen as ion donors. The most applicable salts of copper and silver in medicine are their sulfates and nitrates (CuSO ₄ and AgNO ₃ ). However, insoluble silver sulfate is formed as a result of their mixing. Therefore, its acetate Cu (СН ₃ СОО) ₂ · Н ₂ O was selected from copper salts. Even in the case of the formation of silver acetate (AgC ₂ H ₃ O ₂ ), its solubility under normal conditions corresponds to 10,200 mg / L, which is sufficient to achieve set goals.

For the introduction of these salts in polyethylene glycol, they must be dissolved in water, and then mixed with the base. At the same time, the consistency of the resulting liniment (which was conditionally called Panteleimon) will vary in its density and depends both on the brand of the base itself and on the amount of solution added. It was experimentally found that the desired density of the liniment with a base of polyethylene glycol 600 is obtained by adding no more than 5 ml of solution. And for the base polyethylene glycol 1500, you can add 10 ml of solution.

Two liniment compositions were made with their compositions in wt.%:

Composition Copper acetate Silver acetate Distilled water Polyethylene glycol one 0.2% 0.02% 5% Rest 2 0.5% 0.05% 10% Rest

Both compositions underwent microbiological tests on their effect on the most common pathogenic microorganisms in otitis media: Aspengilus niger, Candida albicans, Pseudomonas auruginosa, Staph. aureus, Staph. Epidermidis, Proteus vulgaris, E. coli.

Microorganisms were cultured on meat and peptone broth to a concentration of 10 ^-9 cfu / ml.

Then, crops were sown on a solid nutrient medium Saburo for cultivation of Asp. niger, and meat and peptone agar for other cultures. Previously, 0.05 ml of a 30% solution of both liniment compositions in physiological saline was applied to solid nutrient media, since at room temperature the liniment changes the gel consistency. Saline was used as a control, which was also applied in an amount of 0.05 ml onto a nutrient medium.

The incubation of the cultures was 24-36 hours for bacteria and fungi of the genus Candida and 5-7 days for micellar fungi.

The antibacterial activity of the liniment emulsions was determined by the absence of a lawn at the place of application of the liniment.

Studies have shown the high activity of both liniment compositions in vitro in relation to all used cultures of bacteria and fungi.

The antimicrobial activity of the liniment was maintained for 6 months when it was stored in the refrigerator chamber at a temperature of + 4 ° C.

To study the preventive properties of liniment, a group of 16 men from 22 to 38 years old, divers, divers was chosen. Representatives of this profession observe the development of otitis externa during the performance of professional duties in more than 30% of individuals.

Swimmers were divided into two subgroups of 8 people. For 20 days, twice a day, morning and evening, using hygienic ear sticks, liniment was applied to the surface of the external auditory canals of the subjects. Moreover, in one subgroup, the 1st composition was used, and in the other, the 2nd composition of liniment. During the 20 days of observation, when the subjects performed their professional duties, there was only one case of otitis in a swimmer-diver who used composition No. 1 (with a lower content of copper and silver).

The study of the therapeutic properties of liniment was carried out on patients suffering from diffuse external otitis media.

The experimental group consisted of 30 people (18 women and 12 men). The control group consisted of 15 people (9 women, 6 men). The age of patients is from 25 to 80 years. Treatment in the control group was carried out by standard methods using antibiotic ointments.

In the experimental group, which was divided into two subgroups of 15 people each, instead of antibiotic ointments, the Panteleimon liniment was used. In one subgroup - composition 1; in another subgroup, composition 2. Method of application: treatment of the skin of the external auditory meatus with cotton swabs 3 times a day.

Observations showed that in the control group, treatment duration averaged 13 days.

In the experimental subgroup where composition No. 1 was used, the duration of treatment averaged 8.5 days. In the subgroup where the 2nd composition was used, the average treatment time was 7 days. The main reason for the extension of time in the control group was the emergence of antibiotic-resistant strains of microorganisms, which required additional measures and treatment time.

In the experimental group, the emergence of resistant strains was not observed. There were no allergic reactions.

The results obtained allow us to draw the following conclusions.

Both liniment compositions have high prophylactic and therapeutic efficacy against external otitis media and are not inferior to standard antibiotic ointments. Liniment does not lead to the development of resistant microflora, which distinguishes it from ointments containing antibiotics.

It is possible to use polyethylene glycol 1500 as the basis of liniments. At the same time, an increase in the concentration of copper and silver ions by a factor of 2.5 will make it possible to predict with greater confidence a favorable result. An increase in concentration within these limits does not lead to the manifestation of allergic reactions.

On the example of the studies proved the applicability of the proposed tool. The compositions of the proposed compositions were not previously proposed and are unknown by experts, which implies compliance with the novelty criterion.

The prior art is proved by the compatibility of the ingredients of the composition and the effectiveness of its action on microorganisms for a long time (at least 6 months).

Based on well-known medical ideas, the results obtained allow us to assume with great confidence that the proposed tool can be used in other areas of medicine, for example: purulent surgery, dermatology, sanitation and hygiene.

Information sources

1. Yu.M. Ovchinnikov, S.V. Morozova. Otorhinolaryngology, Moscow: Mastery, 2002.

2. Russian Patent No. 2190573, Mcl. C 2 F 1/467. Antimicrobial ionizer and method for preparing a therapeutic solution.

3. Application for invention No. 2003115413. Copper-silver ionizer and therapeutic agent with antimicrobial effect. Bull. No 32 on November 20, 2005

Claims (1)

An antimicrobial agent containing copper and silver ions, characterized in that the basis of the agent is polyethylene glycol, and the active active ingredients are copper acetate and silver nitrate, dissolved in distilled water, at their content, wt.%: Copper acetate 0.2-0.5 Silver nitrate 0.02-0.05 Distilled water 5.0-10.0 Polyethylene glycol Rest