RU2314795C2 - Tubes for treating ears - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: device has gelatin ear tubes containing antibiotics, antiseptics, antifungal preparations, homeopathic preparations, substances of vegetable, animal, mineral, synthetic origin and others contributing to prophylaxis and external ear treatment. Gelatin and glycerol are used as auxiliary substances. Gelatin-based drug immobilization provides for prolonged preparation action.

EFFECT: enhanced effectiveness in delivering drugs to lesion focus; avoided pain and mental disorder manifestations; retained hearing function.

Description

The invention relates to medicine, namely pharmacy, to dosage forms for the treatment of diseases of the external ear.

In the prevention and treatment of diseases of the external ear, various dosage forms are used: aqueous and alcohol liquid preparations for instillation in the ear (Otinum ear drops, novimain 0.1% solution, decamethoxin 0.05% alcohol solution, etc.), ointment compositions on turundah et al. (Mashkovsky M.D. Medicines: In 2 vols. - 14th ed., revised., revised and supplemented. - M.: 000 "Novaya Volna Publishing House": Publisher S.B.Divov, 2001. - 540 p., 608 p .; Isakov E.A. Dermatoses of the external ear.// Vestnik of otorhinolaryngology. - 1980 - No. 2 - P.76-77 .; Kunelskaya V.Ya., Chelidze N.D. Modern method for the treatment of patients with otomycosis. // 6th Congress of Otolaryngologists of the Ukrainian SSR: abstracts. - Lviv, 1983. - P.108-109 .; Ovchinnikov Yu.M., Apostolidi KG External otitis. // Russian Medical Journal. - 1997 - No. 3 - p. 47-51 .; Pozdneev V.G., Prytkova M.V. Epidemiology of otomycosis. // Abstracts of the 9th All-Union Congress of Dermatovenerologists. - M. 1991. - S.300-301 .; Tarasov D.I., Kunelskaya V.Ya., Chelidze N.D., Pavlenko S.A. Otomycosis: Method. Recommendations // Moscow Research Institute of Ear, Throat and Nose. - M. 1988. - p.1-2.).

However, liquid preparations for instillation cannot have a long-lasting effect and require frequent administration. Water and alcohol formulations evaporate quickly or are quickly washed off by pus or other discharge. Ointment compositions on turundas require frequent changes, tightly obturate the external auditory canal, impair hearing on the affected side, make it difficult to discharge from the external auditory canal, and prevent its aeration. Medicinal films, due to their size and shape, cannot always be placed in the external auditory canal; they do not always ensure the outflow of discharge from the auditory canal.

The objective of the present invention is to provide an effective dosage form with a wide pharmacological spectrum of effects in diseases of the outer ear.

Ear tubes containing an active substance from the series are proposed:

antibiotics, antiseptic substances, antifungal drugs, homeopathic remedies, drugs of combined action and various origin (synthetic, plant, animal, mineral), as well as gelatin, glycerin as mass-forming components.

Ear tubes are obtained by mixing the active substances with a gelatin-glycerin mass, subsequent formation of the resulting mass in the form of tubes and drying the tubes. The outer diameter of the tubes is from 3 to 6 mm, the inner diameter is from 1.5 to 3 mm, the length is 30 ± 5 mm. Examples illustrating the invention:

Example No. 1.

Lincomycin hydrochloride 1.5 g Gelatin 16.0 g Glycerin 10.0 g Water 30 ml

Example No. 2.

Tea tree oil solution 15%  - 0.6 ml Gelatin 16.0 g Glycerin 10.0 g Water 30 ml

Example No. 3.

Nitrofungin 4.6 ml Gelatin 16.0 g Glycerin 10.0 g Water 30 ml

Example No. 4. Otitis (homeopathic medicine):

Belladonna thirty, Magnesia phosphoricum 6, Kolotsint 6, Hamomilla 6 (125 doses) Gelatin 16.0 g Glycerin 10.0 g Water 30 ml

Example No. 5.

Malavita 2.6 ml Gelatin 16.0 g Glycerin 10.0 g Water 30 ml

In all examples, water is an intermediate agent. It is removed during the drying process.

Ear tube preparation example

A solution of 16.0 g of gelatin in 20 ml of water is prepared. Then 10.0 g of glycerol is added to the solution, the components are mixed. A solution of lincomycin hydrochloride in 10 ml of water is added to the warm (35-40 ° C) gelatin-glycerin mass, the mass is mixed and then formed in the form of tubes of the above sizes. The tubes are dried to a predetermined humidity.

Ear gelatine tubes are used in otorhinolaryngology after a thorough ear closure by introducing them into the external auditory canal.

Medicinal substances that make up the ear gelatin tubes provide the main therapeutic effect. Gelatin has a hemostatic property and the ability to accelerate the healing process. The immobilization of the drug with gelatin ensures the durant effect of the drug. The inner lumen of the tubules provides aeration of the external auditory meatus and the outflow of the discharge from it. The use of the tubes does not cause pain and additional trauma to the external auditory canal.

The simple technology for producing ear gelatin tubes and the cheapness of gelatin provide sufficient cheapness of the drug.

Ear gelatin tubes with nystatin, tea tree oil were used in the treatment of 39 patients with various forms of otitis externa. Treatment of fungal infections of the outer ear by topical application of aural gelatin tubes with nystatin was carried out in 27 patients (16 women, 11 men), the age of the patients was from 18 to 74 years. The duration of the disease is from 2-3 days to 3 years. Unilateral damage to the ear was in 17 patients, bilateral - in 10 patients. Concomitant disease - 5 patients had chronic suppurative otitis media.

After a thorough toilet of the patient, an ear gelatin tube was inserted into the external auditory canal. The procedure was carried out once a day.

The effectiveness of treatment was judged by otoscopic data and the results of smears from the external auditory canal.

As our observations showed, improvement occurred 1–2 days after the start of treatment: patients stopped complaining of pain and itching in the ear, and the amount of discharge from the external auditory canal decreased. In 18 patients, clinical recovery occurred within 4 days from the start of treatment, in 8 from 5 to 6 days, and in 1 from 8 to 10 days. Relapse was observed in 1 patient with a long course of the disease.

Treatment of a bacterial lesion of the outer ear by topical application of gelatin ear tubes with tea tree oil was performed in 12 patients (8 women, 4 men), the age of the patients was from 21 to 50 years. The duration of the disease is from 7 days to 2 years. Unilateral damage to the ear was in 2 patients, bilateral - in 10 patients. As our observations showed, in 5 patients clinical recovery occurred within 5 days after the start of treatment, in 6 patients from 6 to 8 days, and in 1 more than 10 days.

Thus, ear gelatine tubes with medicinal substances are highly effective drugs mainly local action in the treatment of otitis externa.

The proposed tool in this dosage form provides high therapeutic efficacy at low doses of the active substance. In addition, this form gives a prolonged effect, reduces treatment time and preserves drainage and / or aeration of the external auditory canal.

Claims (1)

Ear tubes, characterized in that they contain an active substance selected from the series: antibiotics, antiseptic substances, antifungal drugs, preparations of synthetic, plant, mineral and animal origin and gelatin, glycerin obtained by mixing the active substance with a gelatin-glycerin mass, followed by the formation and drying of the resulting mass in the form of tubes with an outer diameter of 3 to 6 mm, an inner diameter of 1.5 to 3 mm, a length of 30 ± 5 mm.