RU2157206C1 - Bactericidal otogel - Google Patents

Abstract

FIELD: medicine, otorhinolaryngology, pharmacy. SUBSTANCE: bactericidal preparation has ampicillin monosodium salt, oxytocin, agar powder, distilled water in the definite ratio of components. Invention ensures to carry out treatment of patients with chronic suppurative middle otitis and trepanation cavity inflammation. EFFECT: maximal curative effect, absence of adverse effects. 1 dwg, 1 ex

Description

 The invention relates to medicine, namely to medicinal products for external use of bactericidal properties, and can be used in the clinic of ENT diseases in chronic purulent mesotympanitis and inflammation of the trepan cavity after radical operations on the ear.

 The relevance of the local use of antibacterial agents in inflammatory processes of the ear is determined by their targeted exposure and the creation of a sufficient concentration in the pathological focus, providing the most pronounced effect and minimizing systemic side effects. At the same time, the carrier of the antimicrobial drug plays a very important role in stopping inflammation, due to which the pharmacological properties are prolonged and optimal physical conditions of action are created.

 For local treatment with the aim of influencing the pathogenic microflora, various antibacterial and antiseptic preparations are proposed, which are used in the form of solutions, powders, or a combination thereof, as well as in the form of emulsions, ointments; which usually include broad-spectrum antibiotics, taking into account the sensitivity of microflora to them, seeded from the middle ear. Along with this, for local treatment, Kalanchoe juice and ointment, Novoimanin, alcohol and oil solutions of chlorophyllipt, extracts of oak, pine, St. John's wort on glycerin, as well as onion and garlic juice (Brocks DN An onion in your ear // J. Laryngol., Otol. - 1986. - Vol. 100, N 9. - P. 1043-1046).

 At the same time, the use of these drugs in the treatment of patients with chronic mesotympanitis and inflammation of the trepanation cavity after radical operations on the ear is not effective enough: the healing processes of the patients are delayed, and frequent relapses of the disease are noted.

 As a prototype, we took 4% heliomycin ointment. The active substance of the ointment is the antibiotic heliomycin, which is active against gram-positive microbes, some viruses, has low toxicity (MA Klyueva. Reference book “Medicines”, Moscow, 1994).

 However, with the therapeutic use of this ointment, the appearance of antibiotic-resistant strains of microorganisms was noted, while this dosage form in the form of an ointment does not allow heliomycin to penetrate into all parts of the middle ear cavity and trepanation cavity, the purulent discharge is worsened, which reduces the clinical effectiveness of local antimicrobial therapy.

 In this regard, we offer a bactericidal othel for the treatment of patients with chronic purulent otitis media and inflammation of the trepanation cavity.

The novelty of the invention is the integrated use of an antibiotic with oxytocin based on a gel carrier. A significant difference is that the composition of the drug is included (wt.%):
Ampicillin monosodium salt - 2.5
Oxytocin - 20 ME
Agar powder - 5.0-6.0
Distilled Water - Else
A bactericidal gel is prepared as follows:
6.0 wt. % agar powder is placed in 95 ml of distilled water, stirring over low heat until completely dissolved, bring to a boil and boil for 5 minutes. Filter through a double layer of sterile gauze. Allow to cool to a temperature of 35-40 ^o C. Using a measuring tube (test tube with a marked level of 10 ml) pour 10 ml of the prepared gel into vials, add 0.25 wt. % ampicillin monosodium salt dissolved in 2 ml of distilled water and 0.5 ml (2.5 IU) of the ampouled solution of oxytocin, mix gently. Store in a dark place at a temperature of +4 ^o C.

 A distinctive feature of the antimicrobial action of the bactericidal othel (Scheme No. 1) is that agar (gel carrier) adsorbs inflammatory exudate, provides long-term contact with the walls of the ear cavities, and thereby prolongs the bactericidal effect of the antibiotic in its composition. Oxytocin included in the bactericidal othel potentiates the antimicrobial action of the antibiotic by 16-17 times, respectively reducing the total dose of its use, and enhances the processes of immunogenesis.

 Topically, a bactericidal gel was used in the treatment of 45 patients (20 patients with a diagnosis of chronic purulent mesotympanitis, in 25 with inflammation of the trepanation of the ear). The effectiveness of the use of a bactericidal gel was evaluated by the therapeutic effect: reduction and disappearance of pain, suppuration, swelling, hyperemia of the mucous membrane; as well as control bacteriological culture.

A bactericidal gel was introduced through a perforation hole into the cavity of the middle ear or into the trepanation cavity on the ear pad in a volume of 1.5-3 mm ³ .

 As a result of local application of the bactericidal gel twice a day with an interval of 12 hours, otorrhea was stopped on the second or third day, and inflammatory events on the fourth or fifth.

Example 1. Sakvina L.T., 33 years old. Received January 20, 1998 in the ENT department of the 1st city emergency hospital in Orenburg regarding suppuration from the right ear, earache, hearing loss, headache, and fever (t 37.5 ^o C).

 Notes periodic suppuration from the ear over the past two years after acute otitis media, resuming after acute respiratory infections.

When examining a patient in the clinic, the general state of moderate severity. In the general analysis of blood leukocytosis (8.5 • 10 ³ / ml) without neutrophilic shift, ESR 18 mm / h, other blood parameters unchanged. Urinalysis is normal. No pathological changes in the nose, pharynx, larynx and left ear were detected.

 Right ear: the auricle and the area of the mastoid process are not changed, palpation - soreness of the behind and submandibular lymph nodes. When otoscopy: in the right ear canal, purulent discharge, subtotal perforation of the tympanic membrane in the stretched part with calloused edges, the mucous membrane of the medial wall of the tympanic cavity is hyperemic. Diameter of perforation is 5 mm. Acuity of hearing: whispering 1.5 m, conversational 5 m. Rinne's experience is negative, Weber lateralization of sound in the right ear. With tonal audiometry, conductive hearing loss is detected.

 Schuller X-ray of the temporal bone - there is no pneumatization of the temporal bone cells on the right, the bone substance is compact.

 As a result of bacteriological culture from the right tympanic cavity, Staphylococcus aureus was seeded, sensitive to gentamycin, kanamycin, cephalotin, neomycin, orfloxacin, resistant to tetracycline, ampicillin, erythromycin, the level of antilysocyme activity is 3 μg / ml.

 Diagnosis: Right-sided chronic purulent mesothympanitis, exacerbation.

 A bactericidal othel was injected into the tympanic cavity twice a day with an interval of 12 hours on an ear quilted jacket. On the third day of the use of the otogel, the termination of otorrhea was noted, on the fourth - the relief of inflammatory changes.

 During the control bacteriological sowing, the growth of cultures of microorganisms was not detected. The patient was discharged on the fifth day in a satisfactory condition.

 Example 2. Skvortsova N.M., 48 years old. Received November 15, 1996 in the ENT department of the 1st city emergency hospital in Orenburg with complaints of suppuration from the left ear, mild earache, headache, hearing loss.

 In 1991, a radical operation was performed on the left ear for chronic purulent epithympanitis. Relapses of inflammation of the trephine cavity occurred 2-3 times a year after suffering acute respiratory infections and in the absence of care for the trephine cavity.

 When examining the patient, the general condition is satisfactory, the data of laboratory studies of blood tests (except for an increase in ESR - 21 mm / hour) and urine are within normal limits.

 Other ENT organs unchanged.

 Left ear: the skin of the mastoid process and the auricle is not changed. With otoscopy: the auditory meatus is not changed, in the lumen - scanty purulent discharge; the trepan cavity is incompletely epidermized, its walls are hyperemic, edematous, flat granulations at the base of the spur.

 Hearing acuity: whispering - 2 m, conversational - 6 m. Rinne's experience is negative, lateralization of sound to the left.

 On the radiograph of the temporal bone, cell pneumatization is absent, a postoperative cavity in the bone structure is noted.

 During bacteriological examination, Pseudomonas aeruginosa was seeded from a trepanation cavity, sensitive to gentamicin, kanamycin, neomycin, orfloxacin; resistant to erythromycin, cephalomycin, ampicillin, tetracycline; the level of antilysocyme activity is 4 μg / ml.

 Diagnosis: Disease of the operated ear (relapse of inflammation of the trepanation cavity).

 A bactericidal othel was injected into the trepanation cavity twice a day at 12 o'clock on the ear-pad. On the third day of use, the termination of otorrhea was noted, on the fourth - relief of inflammatory changes. During the control bacteriological sowing, the growth of cultures of microorganisms was not detected. The patient was discharged on the sixth day in a satisfactory condition.

 Thus, the proposed bactericidal otogel is easy to manufacture, its production technology can be implemented in any pharmacy, has a low cost.

 Clinical testing of a bactericidal othel showed a pronounced antimicrobial effect, due to the potentiation of oxytocin 15-16 times the bactericidal action of ampicillin monosodium salt. Its use in the treatment of patients with chronic purulent mesotympanitis and operated ear disease has made it possible to reduce the hospital stay of patients by an average of 7-8 days (p <0.001). The drug is indifferent to the mucous membranes of the cavities of the middle ear, hypoallergenic, does not cause side effects.

Literature
1. G. M. Grigoriev, I. I. Tomilov, B. S. Grishin. Methodical instructions "Modern methods of conservative treatment and prescription for the main diseases of the ear, throat and nose." Sverdlovsk, 1989

 2. Brooks D.N. An onion in your ear // J. Laryngol., Otol. - 1986. - Vol. 100, N 9. - P. 1043-1046.

Claims (1)

A bactericidal othel, characterized in that it contains ampicillin monosodium salt, oxytocin, agar powder, distilled water in the following ratio of ingredients, wt.%:
Ampicillin monosodium salt - 2.5
Oxytocin - 20 IU
Agar powder - 5.0 - 6.0
Distilled Water - Else