Formulation for disinfection and cleaning of removable blade dentures

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely dental decontamination agents. A formulation for disinfection of removable dentures represents a solution of cetrimide, silver ions, a stabiliser, a perfume, chitosan succinate, water under certain proportions (wt %).

EFFECT: invention provides more effective disinfection and cleaning of removable blade dentures ensured by a wide spectrum of antimicrobial action on gram-positive, gram-negative microorganisms, fungicidal action on yeast-like fungi, including gen Candida, antiviral action (on enveloped and non-enveloped viruses), micobacteria, as well as provides disadhesion action, the absence of a negative effect on a dental plate surface, reduced time of exposition and non-corrosion activity.

2 tbl, 5 ex

The invention relates to medicine, namely to prosthodontics.

It is known that dentures with bases made of acrylic plastic have an adverse impact on tissue prosthetic bed, changing the balance of the microflora of the oral cavity. When using laminar prostheses in patients usually occurs a deviation from the normal ratio of species of microorganisms in the oral cavity: the number of Escherichia coli increases from 10%to 63%, Candida albicans from 10 to 34%, Staphylococcus aureus from 10 to 22%.

One of the predisposing factors of inflammation of the mucous membrane is open microporosity basic plastic, which serves as a depot for pathogenic organisms. While the depth of the contaminated layer of polymer base reaches 2.0-2.5 mm Presence of microorganisms on the prostheses may cause sensitization and changes in the immunological reactivity of the organism, which typically leads to autoinfection, weakening the mucous membranes of the oral cavity.

In the mouth and throat of a person occurs more than 300 species of microbes. The greatest interest from the point of view of the etiology of inflammatory diseases caused by laminar dentures, are Staphylococcus aureus, Candida albicans, Escherichia coli.

For keeping dentures in proper hygienic condition requires the use of appropriate cleansing the disinfectants. Now for disinfection of dentures are a variety of disinfectants, in which the active substances are: glutaric aldehyde, chloramine, chlorhexidine, alcohol, hydrogen peroxide and others. In many of these tools are strong oxidants, including hydrogen peroxide, which makes the surface of the acrylic bases porous and rough. At the same time, preparations containing as an active start of the compounds from the group of cationic surfactant is a Quaternary ammonium compound (QAC), does not violate the structure of the surface of dentures. These compounds have a limited spectrum of bactericidal action, but when combined with other substances, you can create a disinfectant, has not only bactericidal, and fungicidal, desarguesian and cleansing action.

While disinfectants must have a broad spectrum of antimicrobial activity, which manifests itself in small concentrations, ease of use, to be relatively inexpensive.

Known special tools for cleaning removable dentures mainly imported in the form of a soluble antiseptic tablets, for the preparation of solutions, for example "Protefix" and others, about daysie cleaning ability and short exposure times - 10-15 minutes (Hygiene at the dental prosthesis: a manual / Ulitovsky D.B, - 2nd ed. - M.: Medpress-inform, 2009. - 112 S.).

The composition of the special funds "Protefix includes:

Disadvantages: these tools are relatively expensive and therefore inaccessible to the poor social strata, as well as contain a strong oxidizer, which are detrimental to the surface of the prosthesis basis.

Known analog - disinfecting aqueous solution, for disinfection and sterilization of various objects, disinfection and preservation of drinking water from open freshwater (rivers, lakes, and underground sources (artesian water) and drinking water supply, and is also as a preservative in the food and pharmaceutical industries in the description of the patent No. 2125971, IPC C02F 1/50, A61L 2/16, A23L 3/00, from 1.03.1998, publ. 10.02.1999 containing silver ions and distilled water, and contains silver ions, obtained by electrolysis of solutions using a silver anode, and as a food acid it contains citric or acetic acid in the following ratio, wt.%:

Silver ions Ag+ - 0,1×10-5-1,0

Citric or acetic acid - 0,25-5,0

Food preservative aspartame - 0,05-1,0

Distilled water - the rest

The disadvantage of this composition is not sufficiently high efficiency disinfection of dentures. The acid can corrode the metal parts of a partial removable denture. No cleansing and desarginine properties.

Known aqueous disinfecting composition based on silver ions, Silver water". "Silver water" has a high bactericidal action, and when the concentration of silver ions of 0.05-2.0 mg/DM³for several tens of minutes can destroy the most resistant to the silver ions of the bacterium E. Coli when their concentration 104-107 cells/cm³(Kul L.A. Silver water. Kyiv. Naukova Dumka, 1983).

The disadvantage of this composition is the lack of cleansing and desarguesian properties for prosthesis basis, not enough high efficiency disinfection of dentures, also during long-term storage under environmenta who eat light bactericidal properties of Silver water fall, because of the fall of the concentration of silver ions, is not active against spore-forming bacteria and weakly active against yeast-like fungi, such as fungi of the genus Candida.

Known similar disinfecting aqueous solution intended for disinfection and sterilization of various objects, disinfection and preservation of drinking water from open freshwater (rivers, lakes, and underground sources (artesian water intake and drinking water, and also as a preservative in the food and pharmaceutical industries in the description of the patent No. 2179155, IPC C02F 1/50, A01N 59/16, A61L 2/16, C02F 103:04, 20.03.2001, publ. 10.02.2002 containing silver ions, obtained by electrolysis of solutions using a silver anode, citric or acetic acid, and distilled water in the following ratio, wt.%:

Silver ions (Ag+) - 0,1×10-5-1,0

Acetic or citric food acid - 0,25-5,0

Ethyl medical - 1,0-80

Distilled water - the rest

A concentrated solution of the dried and ground seedlings or tops of potatoes and tomatoes, and juice or aqueous extract of these green plants the initial stage of the growing season (drug "BINGLE) is 0.01-10, or ethyl alcohol medical - 1,0-80, or iodine medical - 0.01 to 10.0, or 5% alcohol RAS is the thief of iodine medical - 1,0-10,0, or hydrogen peroxide is 0.01 to 10.0.

The disadvantage of this composition is the lack of cleansing and desarguesian properties for prosthesis basis, not enough high efficiency disinfection of dentures.

Known analog - gel toothpaste in the description of the patent No. 2113842, IPC A61K 7/16, dated 26.05.1995, publ. 27.06.1998 containing biologically active additives, as well as glycerin, sodium carboxymethylcellulose, sodium lauryl sulfate, flavoring - saccharin, food coloring and water, as a dietary Supplement, it contains chitosan succinate in combination with monophosphate sodium and additionally sorbitol, sodium benzoate or methyl ether, the odorant fruit and silicon dioxide at the following ratios, wt.%:

Glycerin - 5,0-10,0

Saccharin - 0,04-0,1

Sorbitol - 50,0-60,0

Sodium carboxymethylcellulose - 0,7-1,0

The chitosan succinate - 0,2-0,5

Monitoroff sodium - 0,5-0,8

Sodium lauryl sulfate 30% - 4,0-5,0

Sodium benzoate or methyl ether - 0,05-0,5

Silicon dioxide - 5,0-9,0

Flavoring fruit - 0,2-1,0

Food coloring - 0,001-0,003

Water up to 100 g

Disadvantages: this toothpaste is not a high efficiency disinfection of dentures, possess sufficient antimicrobial activity and is not active against fungi of the genus Candida.

Know of antimicrobials " ... the e tool closest to the technical essence and the achieved result is a liquid concentrate "Artool-dent" is designed for cleaning removable dentures from bacterial plaque, food debris or fixing materials, and also for storage of dentures (Dental program" Vladiv, Belgorod, 2010, p.72). The "Artool-dent are: cationic Quaternary ammonium compound centrimonium bromide (cetrimide)indicating microbicide and microbiostatic effect of concentrate; salt of sorbic acid has a fungistatic effect.

Cons: not wide enough spectrum of antimicrobial action, in particular selectively acts on gram-negative bacteria, bezobolochnye and enveloped viruses, and mycobacteria.

Therefore, the required disinfectant, devoid of those disadvantages and affordable sick from poor social backgrounds.

Effect: increased efficiency of disinfection partial and full removable laminar dentures, expanding the range of antimicrobial activity against gram-positive, gram-negative microorganisms, fungicidal activity against yeast-like fungi of the genus Candida and others; desarguesian and cleansing, do not have a negative impact on the surface using the owls prostheses, and does not cause corrosion of metal parts removable laminar dentures; reducing exposure time.

The technical result is achieved due to the fact that the composition for disinfection of dentures containing cetrimide, silver ions, water, characterized in that it further comprises chitosan succinate, stabilizer and flavoring, and silver ions, the obtained electrolytic diffusion with a silver electrode, and cetrimide taken at the following content, wt.%:

New essential features of the invention should be considered qualitative and quantitative composition of disinfectants, as well as the introduction of the chitosan succinate 0,008-1.7 in combination with silver ions 0,0008-0,002, odorant "Cranberry" 0,009-2,2, the stabilizer of 0.9 to 3.2

Improving the efficiency of disinfection partial is fully removable laminar dentures is achieved due to the combined action of the substances introduced - chitosan succinate, silver ions and cetrimide: 0,45-2.2 cetrimide, 0,008-1.7 chitosan succinate in combination with silver ions 0,0008-0,002, odorant "Cranberry" 0,009-2,2, the stabilizer of 0.9 to 3.2.

These substances provide a strong bactericidal action against gram-positive, gram-negative microorganisms, fungicidal activity against yeast-like fungi, including Candida, antiviral effect (on the shell and bezobolochnye viruses, and mycobacteria.

Desarguesian and cleansing action for prosthesis basis is due to the fact that the funds entered chitosan succinate 0,008-1.7 in combination with cetrimide 0,45-2,2, Cetrimide has a high wetting characteristics, chitosan succinate is a surface active substance and has desarguesian properties.

Reducing the exposure time is achieved due to the introduction of the stated means of a new component, chitosan succinate 0,008-1.7 grams in combination with silver ions 0,0008-0,002 grams and cetrimide of 0.45-2.2 g and their cumulative impact on the polluted prosthetic base.

No corrosive action due to the fact that none of the components of the claimed composition does not have severe corrosion activity, and cetrimide with weak corrosivity, taken in minimum sootnoshenie is of 0.45-2.2 wt.%.

Cetrimide - microbial a Quaternary ammonium compound, refers to the cationic surfactants. Has antimicrobial activity against gram-positive bacteria, to a lesser extent against gram-negative bacteria adsorbed on the surface of bacterial cells, destroys their cytoplasmic membrane. Cetrimide not active against spores of bacteria. Has variable antifungal activity, effective against some viruses. It has low corrosiveness and good wetting characteristics ("Cetrimide", veterinary substances data base. Science & Technology Research Institute, UK, 2011; "Cetrimide", Pesticide Properties data base. Science & Technology Research Institute, UK, 2011).

Silver ions is one of the strongest natural antiseptics. Silver ions have a broad spectrum of antimicrobial activity against aerobic and anaerobic microorganisms, including antibiotic-resistant; exhibit antifungal and antiviral activity; anti-inflammatory action.

Succinate chitosan is a natural polysaccharide containing an amino group with high reactivity, high biocidally and adsorption capacity. Chitosan succinate has antibacterial and antifungal action, active against gram, grammology the nutrient bacteria, can absorb toxic substances, soluble in water. Despite numerous studies, the mechanisms of action of this biopolymer on bacterial and fungal flora are not fully disclosed. While chitosan, being a natural product, it is safe to humans and the environment (LD50 16 g/kg of body weight). Odorant "Cranberry"is a clear red liquid, is added to impart a pleasant odor and color to the solution. When such quantities cetrimide 0,45-2,2, chitosan succinate 0,008-1.7 in combination with silver ions, odorants "Cranberry" 0,009-2.2 stabilizer of 0.9 to 3.2 the efficiency of disinfection and purification and partial removable laminar dentures.

The invention

Technology of preparation of the claimed composition

Produced silver water concentration of 10 g/l (water containing silver ions) in a laboratory setup "NEVOTON" with a capacity of 3 l/h of water on a silver electrode (current strength of 10.4 mA, a voltage of 12 V). Diffusion of silver ions occurs with a positive electrode (anode) into the water. The resulting concentrate is diluted with water to the desired concentration.

In water with a concentration of silver ions 0,0008-0,002 dissolves cetrimide at 40°C. Then the resulting solution was added with stirring, chitosan succinate, a hundred is ilitator, the odorant "Cranberry", water to obtain 100 g of the solution at the following content, wt.%:

Example 1

Produced silver water concentration of 10 g/l (water containing silver ions) in a laboratory setup "NEVOTON" with a capacity of 3 l/h of water on a silver electrode (current strength of 10.4 mA, a voltage of 12 V). Diffusion of silver ions occurs with a positive electrode (anode) into the water. The resulting concentrate is diluted with water to the desired concentration.

In water with a concentration of silver ions 0,0008-0,002 dissolves cetrimide at 40°C. Then the resulting solution was added with stirring, chitosan succinate, stabilizer, flavoring "Cranberry", water to obtain 100 g of concentrate at the following content, wt.%:

Example # 2

Carried out analogously to example No. 1, but the solution includes 2.2 g of cetrimide per 100% solution, it is dissolved in water with a concentration of silver ions 0.002 g/l, add 1.7 g of chitosan succinate, 3.2 g of stabilizer, 2.2 g odorants "Cranberry", water to obtain 100 g of concentrate at the following content, wt.%:

Example # 3

Carried out analogously to example No. 1, what about the solution consists of 0.5 g of cetrimide per 100% solution, it is dissolved in water with a concentration of silver ions 0.0015 g/l, add 1.0 g of stabilizer, add 0.5 g of chitosan succinate, 1.0 g of odorants "Cranberry", water to obtain 100 g of concentrate at the following content, wt.%:

Example No. 4

Carried out analogously to example No. 1, but the solution includes 1.2 g of cetrimide per 100% solution, it is dissolved in water with a concentration of silver ions 0.001 g/l, add 1.5 g of stabilizer, add 1.0 g of chitosan succinate, 1.5 g odorants "Cranberry", water to obtain 100 g of concentrate at the following content, wt.%:

Example No. 5

Carried out analogously to example No. 1, but the solution includes 1,9 g cetrimide per 100% solution, it is dissolved in water with a concentration of silver ions 0.002 g/l, add 1.5 g of chitosan succinate, 3.0 stabilizer, 2.0 g odorants "Cranberry", water to obtain 100 g of concentrate at the following content, wt.%:

For disclosure of the invention below are the results of experimental and clinical studies claimed disinfectant.

Antimicrobial activity of drugs known and declared was determined by standard m is codicum, adopted in blaboratory. Used cups with/on blood agar, agar Mueller-Hinton, the concentration of the suspension of microorganisms is 1.5×10^*8CFU/ml, which corresponds to the turbidity standard of 0.5 "Mcfarland". For taking biomaterial used transportation system with the environment of Stewart. The environment contains thioglycolate sodium to create a low redox potential and viability of bacteria is maintained up to 48 hours at room temperature. Fences materials produced from the most contaminated sites prostheses:

1) interdental spaces;

2) the clasps;

3) the inner surface of the prosthesis basis.

As the test culture was used Escherichia coli as a model organism that meets the basic requirements: viral nature, distribution and resistance to external environmental factors. Culture, selected from the crops from the surface of the removable laminar dentures: Staphylococcus aureus - to determine the bactericidal activity of Candida albicans is to determine fungicidal activity.

The results are given in table 1.

Conclusion: the Composition of # 1 and # 3 do not meet the stated requirements antimicrobial activity and have a relatively long exposure times. Formulations # 2 and # 5 do not meet the stated requirements, the AK when the content of chitosan succinate in solution with a concentration of more than 1.5 wt.% observed salustiana solution. Thus, the most good features on the composition No. 4 in the following, wt.%:

This composition is characterized by a relatively small exposure time - 30 minutes

For comparative evaluation of the removal of dental plaque and disinfection of dentures simultaneously studied the activity actions prototype "Artool-dent" (Vladiv, Russia) is a control composition No. 1, which is designed for cleaning and disinfection of dentures and the control composition No. 2 - solution effervescent tablets Protefix (Queisser Pharma, Germany), designed to cleanse and disinfect dentures.

For the clinical study of the effectiveness of disinfection and cleaning removable prosthetic investigated 60 removable orthopedic prostheses, various designs have 34 people. Ages ranged from 45 to 84 years. The index of cleanliness of dentures when you first visit was 3.0 to 5.5 (Ulatowska-Leontiev, 2008), i.e., satisfactory, poor or very poor level of cleanliness of dentures. During the observations was used prosthetic, as fresh, and with the period of use from 6 months to 6 years. All patients were randomly divided into three groups according to the method of cleaning dentures. Patients of the first group recommended to immerse their dentures in the claimed solution, the WTO is Oh - the use of a solution Artool-dent - control composition No. 1, the third - in solution effervescent tablets Protefix control composition No. 2. Exposure in all three cases was 30 minutes. The examination was performed at 15, 30, 45 days. Dynamic monitoring of the hygienic condition of the prosthetic index definition hygiene and microbiological research indicates a higher deadening, disinfection and cleansing efficiency of the claimed solution and a relatively lower cleanability solutions "Artool-dent" (Vladiv) and Protefix (Queisser Pharma, Germany). The results of microbiological tests are shown in table 2.

Control of hygienic condition was performed using hygienic index Ulytauskogo-Leontiev, 2008

The index of cleanliness of dentures Ulytauskogo-Leontiev =,

where Σ is the sum of quantitative evaluations criteria

a₁-the number of points on the first criterion,

a_n- the number of points on the n-th criterion

n is the number of criteria used in the index.

Control dynamics maintain the quality of the cleanliness of dentures was carried out by using the formula for calculating the efficiency of purification of the prosthesis (%):

The purification efficiency of prostheses = [(ECP₁-Company_n)×100]/ECP₁,

where company₁- digital index PE Ulytauskogo-Leontiev, a certain paragraph and the first visit,

Company_n- digital index PE Ulytauskogo-Leontiev, specific for n-th visit.

When using the claimed composition was observed positive dynamics of changes in the quality of purification removable laminar dentures from 20.0% (very low purification efficiency of removable dentures) in early use, to 90.0 100.0% of (high efficiency purification removable dentures) after 45 days of observation.

During clinical observations experimentally determined the effect of disinfectants on the base plastic dentures and metal inclusions within one month of the standard samples. Weight changes of the samples, color, relief on their surface, corrosion was found.

Thus, on the basis of laboratory and clinical observations, we can conclude that our proposed hygienic means for disinfection and cleaning of dentures has absolutely antimicrobial, fungicidal activity, with short-term exposure, well remove soft plaque, does not change the color of the plastic and does not cause corrosion of metallic impurities removable laminar dentures.

Composition for disinfection of dentures containing cetrimide, silver ions, water, characterized in that it further comprises chitosan succ the NAT, stabilizer and flavoring, and silver ions, the obtained electrolytic diffusion with a silver electrode, and cetrimide taken at the following content, wt.%: