RU2706010C1 - Dental gel - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to dentistry, and can be used for prevention and treatment of inflammatory periodontium and oral mucosa diseases. Described is a dental gel containing guaiazulene, sage oil, cloves, thyme in gel base in contrast to prototype is a hydrophobic gel "Hydrophobes Basisgeb" (Gelatum basalis hydrophobicum) containing melaleuca oil, cacao butter and pectin, with the following ratio of components, wt%: guaiazulene – 0.03–0.09, pectin – 4.0–4.5, sage oil – 0.2–0.4, thyme oil – 0.1 –0.3, cloves oil – 0.4–0.8, cacao butter – 0.1–0.3, melaleuca oil – 0.1–0.3, hydrophobic gel "Hydrophobes Basisgeb" (Gelatum basalis hydrophobicum) – balance.

EFFECT: prevention and treatment of periodontium and oral mucosa.

1 cl, 1 tbl, 6 ex

Description

The invention relates to medicine, namely to dentistry, and can be used for the prevention and treatment of inflammatory diseases of periodontal and oral mucosa.

Dental gel has anti-inflammatory, anti-allergic, anti-edematous, antiseptic, regenerating effects, has enveloping and cytoprotective properties, and has antioxidant properties.

The prior art compositions for the prevention of periodontal diseases in the form of toothpastes, elixirs, rinses containing fluorides, plant extracts, minerals, perfume, water, such as compositions according to patents RU 22004990 of 05.27.2003, SU 1837867 of 05.09.91, Parodontol toothpaste with green tea extract (patent RU 2241437, dated 10.12.2004), New Pearl, Parodontax toothpastes.

The disadvantages of such pastes include low efficiency, weak anti-inflammatory and decongestant effects, the absence of a pronounced antimicrobial effect on periodontal tissues and the need for their constant long-term use.

The well-known "Composition for the prevention and treatment of periodontal disease and oral mucosa", patent RU No. 2158125, publ. 10.27.2000, A61K 7/16, containing polyvinylpyrrolidone, sodium lauryl sulfate, ethyl alcohol, crystalline menthol, perfume, water, antiseptic preservative-nipagin, Fucus aqueous extract and xylitol-sorbitol syrup in combination with polyvinylpyrrolidone.

The disadvantages of the known funds include the content in it of such synthetic substances as sodium lauryl sulfate, preservatives, which give an unpleasant aftertaste. The tool is multicomponent, which complicates its manufacture. In addition, the known tool is a liquid for rinsing, which requires a large flow rate and makes it not effective enough.

The known composition (RF patent No. 2201206, A61K 7/26, publ. March 27, 2003) for the treatment of periodontal disease, containing aqueous extract of eucalyptus, soybean oil, distilled monoglycerides, higher fatty alcohols, cosmetic stearin, propylene glycol, nipagin, peppermint oil , alpha-tocopherol acetate, provitamin coniferous concentrate, purified water.

The disadvantage of this composition is a weak anti-inflammatory effect, which reduces the effectiveness of treatment and the speed of elimination of the main symptoms of periodontitis, such as bleeding and increased tooth sensitivity, as well as the need to use a specially made mouthguard, which is located in the affected area.

A known composition for the local treatment of periodontal and mucous diseases according to the patent (RF patent No. 2190995, A61K 6/02, publ. 20.10.2002). The composition contains tinctures of chamomile and calendula, rosehip extract, sanguirythrin, a biopolymer base (2% acetic acid solution of collagen and sodium alginate) and water.

The disadvantage of this composition is the very weak direct anti-inflammatory effect and inconvenience of use in the form.

Also known composition for the treatment of inflammatory periodontal diseases (patent RU No. 2228168, 2004), containing thymol, sodium fluoride, phenyl salicylate, eugenol, clove oil, sage oil, peppermint oil.

The disadvantage of this composition is the need for repeated rinses, which also need to be duplicated by rubbing the drug into the lesion with a cotton swab. The duration of the treatment course.

As a prototype, a composition was selected, according to the application for the invention No. 2016113862, “L-gel dental”, containing sage, clove, thyme, hypromellose oils in Basegel Gelatum hy drophobicum gel.

The proposed solution improves the efficiency of the prototype.

The aim of the invention is the creation of an effective natural drug in the form of a gel for the prevention and treatment of inflammatory diseases of periodontal and oral mucosa.

The benefits of gels are:

- prolonged action of active substances;

- simplicity of technology;

- convenience;

- comfort in use;

- the internal structure of the gel allows you to include chemically incompatible substances in its composition;

- the ability to linger on the gums and oral mucosa (like a solid body);

- effectiveness with application effects, due to the adhesive properties of the gel.

This object is achieved in that the dental gel containing guaiazulene, sage oil, clove, thyme in a gel base, in contrast to the prototype, is a hydrophobic gel “Hydrophobes Basisgel” (Gelatum basalis hydrophobicum) containing tea tree oil, cocoa butter and pectin in the following ratio components, wt.%:

Guaiazulen 0.03-0.09 Pectin 4.0-4.5 Sage oil 0.2-0.4 Thyme oil 0.1-0.3 Clove oil 0.4-0.8 Cacao butter 0.1-0.3 Tea tree oil 0.1 - 0.3 Hydrophobic gel "Hydrophobes Basisgel" (Gelatum basalis hydrophobicum) Rest

All components that make up the gel are natural and are approved for medical use:

- Guaiazulen (1,4-Dimethyl-7- (2-propyl) azulene), Code FS-001290, Safety Data Sheet in accordance with Regulation (EC) 1907/2006 (REACH) (Registration, Evaluation and Authorization of Chemicals) - Synthetic an analogue of the main active ingredient of chamomile pharmacy, anti-inflammatory, anti-allergic, local anesthetic, antioxidant agent that stimulates regenerative processes. Guaiazulene is a derivative of azulene. The powder is bright blue;

- Pectin - food supplement E-440 and an adjuvant in the preparation of many dosage forms;

- Sage oil (oleum Salviae) - a strong anti-inflammatory and antiseptic, which is an excellent flavoring, safety data sheet in accordance with Regulation (EC) 1907/2006;

(REACH);

- Thyme oil (Thymus oleum) stimulant of immunity in infectious diseases, safety data sheet in accordance with Regulation (EC) 1907/2006 (REACH);

- Clove oil (oleum Eugenia Caryophyllata) has active antibacterial, soothing and regenerating properties, safety data sheet in accordance with Regulation (EC) 1907/2006 (REACH);

- Tea tree oil (Melaleuca oleum) - has anti-inflammatory, antiviral, antiseptic, antibacterial and antifungal effects;

- Cocoa butter (Theobroma oleum) - has the properties of an immunomodulator, antioxidant and healing agent;

- Hydrophobic gel - a base with pronounced hydrophobic properties "Hydrophobes Basisgel" (Gelatum basalis hydrophobicum), - manufacturer "Caesar & Loretz GmbH", Herderstr. 31, 40721 Hilden, (Germany), safety data sheet in accordance with Regulation (EC) 1907/2006 (REACH). Hazard statements for humans and the environment: Not a hazardous substance under EUChemikaliengesetzgebung.

The difference from the known prototype is the combination of the introduction of pectin together with a combination of tea tree oils and cocoa butter.

In addition to the manifestation of known properties, each component of the claimed composition in aggregate enhances its effect, which is explained, obviously, by their synergism and provides a synergistic effect with higher results of treatment and prevention of periodontal disease and oral mucosa. The introduction of pectin in combination with tea tree oil enhances the therapeutic effect.

As a result of experimental studies, it was found that the hydrophobic gel dosage form provides reliable fixation and provides a prolonged effect of the drug in the oral cavity. Dental gel provides convenience and hygiene of use, forms a fixed thin non-slip film, is resistant during storage, and also has good organoleptic qualities, is pleasant in taste and smell, has a pleasant appearance.

Received a dental gel as follows.

Example 1. In the hydrophobic gel "Hydrophobes Basisgel" (Gelatum basalis hydrophobicum) was added pectin (in the amount according to example 1 of table 1) and all was mixed until smooth. As a result of this procedure, an adhesive gel base was obtained. Then, in turn, sage oil, thyme oil, clove oil, tea tree oil and cocoa butter were added. All were mixed until uniform and guaiazulene was added last. Received a uniform gel, blue, spicy taste.

The invention is illustrated by examples 1-5, obtained analogously to example 1, example 6 without the content of cocoa butter and tea tree are shown in table 1.

A study of the qualities of various compositions of a dental gel made according to examples 1-6 revealed that the composition described in examples 1, 2, 3 is optimal in terms of consistency, ease of use, and treatment effectiveness.

It is noted that the composition of example 4 has insufficient adhesive, enveloping abilities and organoleptic qualities.

The composition according to example 5 has a too thick consistency, making it difficult to uniformly apply the gel, with the same therapeutic effect as in examples 1, 2, 3.

The composition according to example 6 - the therapeutic effect was much weaker than in examples 1, 2, 3, 5.

Therefore, as the optimal composition of the dental gel, the composition according to examples 1, 2, 3 was adopted.

To assess the therapeutic effect of the proposed dental gel tests were conducted. Dental gel was used to treat and prevent acute and chronic diseases of the periodontium and oral mucosa in patients undergoing outpatient treatment. Patients aged 25 to 40 years of different sexes were divided into the main (10 people) and the control group according to the prototype (10 people). The treatment period was 7-14 days. Clinical effects in the main group appeared 3 days after the start of treatment and resulted in a quick relief of signs of inflammation, early regeneration of periodontal pockets, a decrease in bleeding gums after 4 days, elimination of tooth mobility of the first degree and a decrease in the second after 14 days. In patients of the control group, the clinical effect appeared only after 17 days of treatment.

All patients underwent a medical examination. When assessing the subjective opinion of patients, all noted a positive effect, side effects were not observed. When evaluating the results of clinical observations, the fact of eliminating the symptoms that occur with periodontal diseases is confirmed.

Thus, the proposed dental gel allows not only to expand the range of products for the treatment of inflammatory diseases of the periodontium and oral mucosa, but also to reduce the duration of treatment due to the high therapeutic effect due to the regenerating, anti-inflammatory, immunomodulating, antibacterial effect with long-term fixation on the gums, which contributes to prolonged action of the drug.

The proposed dental gel is simple to manufacture and comfortable to use, which makes it practical and convenient to use it in dental practice.

Claims (2)

A dental gel containing guaiazulene, sage oil, clove, thyme in a gel base, unlike the prototype, is a hydrophobic gel Hydrophobes Basisgel (Gelatum basalis hydrophobicum) containing tea tree oil, cocoa butter and pectin in the following ratio, wt.%: Guaiazulen 0.03-0.09 Pectin 4.0-4.5 Sage oil 0.2-0.4 Thyme oil 0.1-0.3 Clove oil 0.4-0.8 Cacao butter 0.1-0.3 Tea tree oil 0.1-0.3 Hydrophobic gel "Hydrophobes Basisgel" (Gelatum basalis hydrophobicum) Rest