RU2226383C1 - Medicinal preparation for treating inflammatory diseases of mouth cavity - Google Patents

Abstract

FIELD: medicine, stomatology. SUBSTANCE: the suggested gel contains metronidasol, oxymethyluracil, copolymer of styrene and maleic anhydride, glycerol, water. The components mentioned should be taken at certain quantitative ratio. Stomatological gel is of prolonged regenerating, antiphlogistic, immunomodeling and antibacterial action. EFFECT: higher efficiency of therapy.

Description

The present invention relates to medicine, namely to pharmacy, and relates to the development of a medicament containing metronidazole and oxymethyluracil, and can be used to treat inflammatory diseases of the oral cavity (gingivitis, periodontitis, stomatitis).

Known drug having the antibacterial action “Metrogil Dent” with the following ratios of ingredients: metronidazole 1%, chlorhexidine 0.25% [1].

The described drug having an antibacterial effect is the closest analogue to the invention according to the technical essence and the achieved result.

However, a known drug containing metronidazole, chlorhexidine and a base has the following disadvantages. The therapeutic effect of metronidazole and chlorhexidine has an antibacterial and anti-inflammatory effect on the gums, but does not have immunomodulating, regenerating and prolonged action.

The objective of the invention is the creation of a new domestic drug in the form of a gel containing metronidazole, oxymethyluracil and a gel base, with regenerating, anti-inflammatory, immunomodulating and antibacterial effects, with good fixation and uniform distribution on the gums due to the gel base, ease of use, expressed in prolonged, expressed in the action of the drug.

The technical result is a reduction in the treatment of patients with inflammatory diseases of the periodontium and oral mucosa due to good fixation on the gums and prolonged action, as well as the convenience and hygiene of use.

This object is achieved in that the claimed gel for the treatment of inflammatory diseases of the oral cavity contains the active substances metronidazole, which has an antimicrobial and anti-inflammatory effect, oxymethyluracil, which has an anti-inflammatory, immunomodulating and accelerates regeneration effect, and a gel base, which includes a styrene-maleic anide copolymer and maleic anhydride purified water with antiviral effect in the following ratio of components, wt.%:

Metronidazole 5

Oxymethyluracil 5

Styrene copolymer

with maleic anhydride 2

Glycerin 5

Purified water Up to 100

All components that make up the gel are approved for medical use. Metronidazole (FS 42-2283-93). Oxymethyluracil (VFS 42-2730-96). A copolymer of styrene with maleic anhydride (CCMA) or modified Plastigel styromal a rare cross-linked water-swelling polymer (Patent for the treatment of herpetic keratitis, patent No. 2135187, 1999, IPC A 61 K 31/765), (TU 6-01-02274010913 -01) - the product of the copolymerization of styrene with maleic anhydride, modified with ammonia, is a white powder. Appearance of a 2% solution of styrene copolymer in water - a clear or slightly turbid liquid - gel. Soluble in water - swells, soluble in glycerin, alcohol.

As a result of experimental studies, it was found that a 2% gel base provides reliable fixation of the drug on the skin and mucous surfaces, promotes a better distribution of metronidazole and oxymethyluracil in the base, a thin, even and continuous smear, the gel base has a prolonged effect and increases the bioavailability of metronidazole and oxymethyluracil due to surface-active properties. Giving the drug a gel form provides convenience and hygiene of use, the drug forms a fixed thin non-slip film, storage stability.

In addition to the manifestation of known properties, each component of the claimed composition in the aggregate enhances its effect, which is explained, obviously, by their synergism.

Example 1. The composition of 100.0 dental gel: metronidazole - 5.0; oxymethyluracil - 5.0; SSMA - 2.0; glycerin - 5.0; purified water to 100.0.

Get the dental gel as follows. A copolymer of styrene with maleic anhydride is dissolved in a beaker at room temperature in purified water (FS 42-2619-97), stirred with a stirrer and allowed to swell for 60 minutes, glycerin is added, metronidazole is dissolved and pre-ground oxymethyluracil powder is introduced. The finished dental gel is a uniform turbid gel of white color, density - 1.5 g / cm ³ , gel pH - 6.0. The resulting gel has a normal consistency, with gingivitis it is easily smeared on the gum area with the formation of a thin even continuous smear, with periodontitis after removing dental deposits, periodontal pockets are easily treated with gel and an application is made on the gum area, which due to the consistency and physicochemical properties of the gel base is reliably held on the gingival surface and the incoming surfactants, has a prolonged effect, and is also convenient and hygienic in use due to the offer the composition of the ingredients.

Example 2. The composition of 100.0 dental gel: metronidazole - 5.0; oxymethyluracil - 5.0; SSMA - 1.0; glycerol-5.0; purified water to 100.0.

A gel is made in a similar manner. The resulting gel has a liquid consistency, when applied, it drains from the gum surface, the smear is uneven, the application is not sufficiently fixed.

Example 3. The composition of 100.0 dental gel: metronidazole - 5.0; oxymethyluracil - 5.0; SSMA - 3.0; glycerol-5.0; purified water to 100.0.

A gel is made in a similar manner. The resulting gel has a thick and viscous consistency, there are inconveniences when applying and applying to the surface of the gums and periodontal pockets, the smear is uneven.

Example 4. The composition of 100.0 dental gel: metronidazole - 5; oxymethyluracil - 5.0; SSMA - 2.0; glycerol 1.0; purified water to 100.0.

A gel is made in a similar manner. The resulting gel has a normal consistency, but there are inconveniences - unevenness when applied to the mucous membrane of the gums and applications, due to the low content of glycerol plasticizer.

Example 5. The composition of 100.0 dental gel: metronidazole - 5; oxymethyluracil - 5.0; SSMA - 2.0; glycerol 10.0; purified water to 100.0.

A gel is made in a similar manner. The resulting gel has a liquid consistency, there are inconveniences - dripping from the applied surfaces, unevenness when applied to the mucous membrane of the gums, applications are poorly fixed and slide on the surface, due to the high content of glycerin plasticizer.

From the above examples it is seen that the composition described in example 1 is optimal from the point of view of consistency, ease of use, treatment effectiveness.

Clinical trials have shown that the amount of applied dental gel preparation at a given ratio of components is the same in the studied patients. This enables the doctor in practical medicine, depending on the form and severity of the disease, to recommend to patients the application of the dental gel on the gums and applications on their own, which makes the inventive gel a promising dosage form in dental practice. After conducting full-scale clinical trials for the treatment of gingivitis and periodontitis of moderate severity, stomatitis and the development of quality control methods, a pharmacopeia article is planned.

Sources of information taken into account:

1. Grudyanov A.I., Dmitrieva N.A., Ovchinnikova V.V. The dependence of the antimicrobial effectiveness of the drug “Metrogil Dent” on the duration of local administration for inflammatory periodontal lesions // Periodontology. -2001. -№1-2 (19-20). -C.32-36.

Claims (1)

Dental gel for the treatment of inflammatory diseases of the oral cavity, containing metronidazole and a base, characterized in that it additionally contains oxymethyluracil, and as a base it contains a copolymer of styrene with maleic anhydride, glycerin and purified water in the following ratio, wt.%: Metronidazole 5.0 Oxymethyluracil 5.0 Maleic anhydride styrene copolymer 2.0 Glycerin 5.0 Purified water Up to 100.0