RU2352351C1 - Dental elixir for prevention of teeth caries - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention concerns pharmaceutical industry, in particular, an agent for prevention of teeth caries. The tooth elixir for prevention of teeth caries, containing fluoride of sodium, glycerin, infusion of a labrador tea marsh, creeping myrtle, peppermint, tillet, and also Kislovodskaya Celebnaya mineral water, taken in a certain ratio.

EFFECT: above described tooth elixir is effective for prevention of teeth caries.

1 tbl, 1 ex

Description

The invention relates to dentistry, namely to means for the care of teeth, oral cavity and mouthwash.

A known group of dental elixirs for the treatment and prevention of dental caries. In particular, a dental elixir is known containing plant extracts, glycerin, perfume and water (A.S. No. 646981, CL 61 K 7/26, 1978), a dental elixir containing ethyl alcohol, fragrance and water is also known (A. S. USSR No. 1412788 class. A61K 7/16, 1988). The main disadvantage of these elixirs is their low anticariogenic effect on hard tooth tissues.

The “Special” dental elixir is known from the prior art, containing vitamin B ₁ and sodium fluoride as the main active elements, which has high cleansing, deodorizing, remineralizing and antimicrobial properties. Known dental elixir "Meadow", containing 5% aqueous extract of horsetail and coltsfoot. It has cleansing, deodorizing and anti-inflammatory properties. Also known is the dental elixir “Ideal”, which contains pepsin, citric and boric acids as an active ingredient, which has a pronounced antimicrobial effect and is recommended as a cleansing and deodorizing agent, as well as to enhance saline secretion [1].

Known means for treating the oral cavity, preventing the appearance of soft microbial and food plaque on the teeth (prototype), containing an anti-caries additive - sodium fluoride, glycerin, as well as plant extracts [2].

The disadvantage of these dental elixirs is their high specificity and narrow therapeutic focus, i.e. effective fight against only one of the many factors contributing to the development of dental caries, in addition, their prolonged use suppresses saprophytic bacteria in the oral cavity and leads to dysbiosis.

Thus, recently in dentistry several methods for the prevention of dental caries using dental elixirs have been formed. For one, the composition of the dental elixir must necessarily include substances that contribute to the remineralization of tooth enamel, for example sodium or calcium fluoride, for the other elixir an antimicrobial effect is necessary, for the third - it is enough to increase the excretory function of large salivary glands to increase the washing and cleansing ability of saliva.

The task was to develop a dental elixir for the prevention of dental caries, which has both antimicrobial, remineralizing, deodorizing and cleansing effects, not suppressing saprophytic flora of the oral cavity, which can be used for a long time.

The problem is solved by introducing into the composition of the tooth elixir containing polyhydric alcohol, components of medicinal plants, sodium fluoride and mineral water, polyhydric alcohol - glycerol, infusion of marsh rosemary, periwinkle, peppermint and linden cordate, sodium fluoride, Kislovodskaya healing water mineral water ", In the following ratio of components, wt.%:

Polyhydric alcohol 8-12 Infusion of marsh rosemary 4-6 Infusion of periwinkle small 2-4 Peppermint Infusion 6-8 Heart-shaped linden infusion 4-6 Sodium fluoride 0.001-0.005 Mineral water "Kislovodskaya healing" rest

The parameters of the components introduced into the composition of the tooth elixir were determined empirically. The introduction of components below the lower or higher than the upper limit does not provide optimal exposure, and also worsens the presentation of the elixir.

Characterization of the components of the tooth elixir

Polyhydric alcohol (glycerin) - has a stabilizing effect, softens and fixes the composition.

Infusion of marsh rosemary has a bactericidal and salivary fluid effect, a small periwinkle - increases the resistance of capillaries, has an antimicrobial effect, peppermint - an antiseptic, refreshing effect, linden cordate - a bactericidal, antimicrobial and refreshing effect, increases salivation. A common property of all selected medicinal components of the claimed dental elixir is a pronounced concentration of molybdenum, which is a trace element that impedes the development of dental caries due to the effect on the kinetics of enamel mineralization and delay of fluoride ions [3].

Sodium fluoride is a tool that can compensate for the nutritional deficiency of a growing crystal, isomorphically incorporated into the enamel apatite, change the mineralization kinetics, and prevent the adsorption of organic substances and microorganisms on the enamel surface.

The basis of the product is Kislovodskaya healing water (Podkumsky section of the Kislovodsk deposit, SKV.2-PE TU 9185-005-36842140-98), meets GOST 13273-88 and is sulfate-bicarbonate and sodium-magnesium-calcium, with a mineralization level 3.0-4.0, has a basic ion content of 1 dm ³ (mEq%) HCO ₃ 50-80, SO ₄ 20-35, Cl <20, Ca 40-60, Mg 20-30, (Na + K) 20-25, CO ₂ - 1200-2050. pH 7.2-8.4 (slightly alkaline). This water helps to remineralize tooth enamel, strengthen bone tissue, increase and maintain an alkaline environment for a long period of time.

The tooth elixir is a homogeneous clear liquid of light yellow color with a pleasant mint smell and fresh taste with a pH of 6.9-8.4.

The elixir is used as follows: 30-40 drops or 1 tablespoon in 1/3 cup of warm water. Rinse intensively for 5-7 minutes after each meal, brushing your teeth in the morning and evening. Depending on the clinical situation, it is possible to use a double dose of elixir.

The method of preparation of the tooth elixir

Example 1. The number of components is given per 1000 kg of the finished product.

A mixture of 80 kg of glycerol (polyhydric alcohol) and infusion of marsh rosemary (40 kg), periwinkle (20 kg), peppermint (60 kg) and heart-shaped linden (40 kg) are separately prepared, the mixture is thoroughly mixed until completely dissolved. Then, the Kislovodskaya healing water mineral water is successively poured into the reactor, the prepared mixture of glycerin with medicinal components is added, sodium fluoride (0.01 kg) is added, and stirred at room temperature for 60 minutes. The resulting liquid is sedimented for 24 hours, then filtered and served on packaging.

Example 2. Composition, kg:

Polyhydric alcohol 120 Infusion of marsh rosemary 60 Infusion of periwinkle small 40 Peppermint Infusion 80 Heart-shaped linden infusion 60 Sodium fluoride 0.05 Mineral water "Kislovodskaya healing" rest

The method of preparation of the dental elixir of example 2 is similar to example 1.

Comparative organoleptic and physico-chemical parameters of the claimed elixir and prototype are presented in the table.

Table Name of indicator The inventive elixir Prototype 1. Appearance ^{1) of the} dental elixir Homogeneous clear liquid Heterogeneous opaque liquid 2. Color Intrinsic to the color of liquid SGPR of this denomination Intrinsic to the color of liquid SGPR of this denomination 3. The smell of a dental elixir Peculiar to the smell of liquid SGPR of this name Peculiar to the smell of liquid SGPR of this name 4. The taste of the tooth elixir Intrinsic to the taste of liquid SGPR of this appellation Intrinsic to the taste of liquid SGPR of this appellation 5. Hydrogen pH 6.8-8.0 5-7 6. Mass fraction of the amount of heavy metals,%, no more 0.002 0.05 7. Mass fraction of fluorides ²⁾ 0.01-0.05 0.1-0.3 8. Mass of fluorides in a unit of packaging, mg, no more 120 240 9. Mass fraction of ethyl alcohol ³⁾ ,%, no more - 120 10. Mass fraction of microelements,% not less 0.05-1.0 SGPR - oral hygiene product 1) A slight opalescence is allowed in cases if this is due to the recipe 2) The mass fraction of fluorides is determined in fluoride-containing liquid SGPR 3) The mass fraction of ethyl alcohol is determined in alcohol-containing liquid SGPR

From the data presented in the table it can be seen that the claimed dental elixir fully complies with GOST R 51577-2000 "Liquid oral hygiene products. General specifications. "

In the course of microbiological research it was found that the developed dental elixir under the conditions of the tests (dilution 1:10) does not have an inhibitory effect against the saprophytic flora of the oral cavity. In 1 g of the drug is allowed no more than 0.001 ² aerobic bacteria and fungi in total in the absence of bacteria of the Enterobacteriaceae family, Staphylococcus aureus, Pseudomonas aeruginosa. These indicators make it possible to attribute the developed elixir to the 4th hazard class according to GOST 12.1.007 - low-hazard substances and does not cause changes in the quantitative and species composition of the normal microflora of the oral cavity.

The shelf life of the finished product (dental elixir) is set at 2 years. Storage conditions (correspond to GOST 27429): storage temperature - not lower than + 5 ° С and not higher than + 25 ° С in covered storage rooms in the manufacturer’s packaging.

The dental elixir according to example 1 can be used in children and adolescents with a KPU index of 0-2.5 (low prevalence and intensity of dental caries), as in example 2 - in children and adolescents with a KPU> 3.5 and above (average prevalence and intensity tooth decay).

Good compatibility of these components with known medicinal properties ensures a synergy of their action, leading to the emergence of new properties and a wide range of pharmacological effects. The inventive dental elixir increases the washing, cleansing and remineralizing abilities of saliva, restores the acid-base balance in the oral cavity, has a pronounced antimicrobial, remineralizing, deodorizing and cleansing effect while maintaining the natural microflora of the oral cavity.

Such a complex effect is achieved due to the ratio of the introduced components defined in the claimed composition of the elixir.

Case Studies

The developed dental elixir was included in the comprehensive "Dental Disease Prevention Program" implemented in the Stavropol Territory, as one of the hygiene products for the prevention of dental caries in children of preschool (5 years old) and school age (6-12 years old) - index age groups according to WHO (1986).

During the study, patients were asked to use various dental elixirs, depending on the chosen means of hygiene, all patients were divided into 5 groups of 124 people. To compare the clinical and microbiological effectiveness of therapeutic and prophylactic elixirs, we have chosen elixirs that are close in composition and have an effect on periodontal tissues.

The first comparison group included patients who used the Ideal dental elixir (prototype) containing pepsin, citric and boric acids. The second comparison group used the Forest Balsam tooth elixir, the active components of which are extracts: coniferous-carotene, fir, sage, oak bark. The third comparison group used the “Mint” dental elixir containing extracts of sage, chamomile, rosemary, lemon balm, peppermint.

The fourth group included patients who used the Lacalut tooth elixir, the active components of which are chlorhexidine bigluconate, aluminum lactate, allantoin and bisabolol.

The main group consisted of patients who used the inventive dental elixir throughout the study period.

The examination was carried out according to a standard method with filling out a patient examination card. The diagnosis was made on the basis of clinical data and the results of an X-ray examination. To assess the hygienic condition of the oral cavity and the cleaning properties of the studied dental elixirs, the OHI-S Hygiene Index was used. Anti-inflammatory effect was evaluated by determining the PI index; gingival index Silness-Loe; bleeding index according to Muhlemann (1971). The increase or decrease in the intensity of dental caries was evaluated using the index of CPU.

The assessment of the indices was determined during control examinations before the start of the study, throughout the study and at the end, i.e. after 12 weeks. The antimicrobial efficacy of dental elixirs was evaluated based on microbiological data.

During a month's observation, in the fourth comparison group, where the Lacalut therapeutic and prophylactic elixir was used, the local irritating effect of the elixir was observed in 14.3% of cases, which manifested itself in the appearance of dryness and a feeling of tightness of the oral mucosa. In patients of all groups, during the use of dental elixirs, the hygienic condition of the oral cavity significantly improved. This is evidenced by the average rate of reduction of the Green-Wermillion index, but the highest degree of reduction was obtained in the main group using the claimed elixir (73.1%).

The greatest degree of reduction of the periodontal index Russell was observed in groups using the claimed composition of the elixir - 58.1% and the elixir "Lacalut" - 57.9%. Thus, in this case, a correctly selected combination of medicinal herbs, mineral water, and sodium fluoride in the developed tooth elixir made it possible to show high antibacterial activity without the use of an antibacterial agent of non-natural origin (chlorhexidine bigluconate).

Microbiological examination of the material during the initial examination revealed representatives of periodontopathogenic bacterial species, and in 35.7% of cases Candida spp was isolated. in each group. After topical application of all dental elixirs that do not contain an antiseptic of chemical origin, the species composition of bacteria of the gingival sulcus / pocket has practically not changed. But it was noted on average up to 14.3% of cases of a decrease in the sowing rate of Candida spp. In the main (claimed composition), 1st, 2nd and 3rd groups. However, when applying the inventive dental elixir, the most pronounced decrease (2.3 times) in the contents of the smear of all types of bacteria was noted, compared with the control groups.

In the study of the microbiological activity of the elixir “Lacalut”, a decrease in the smear content of all types of bacteria was also noted (by 1.9 times). But at the same time, there was an increase in the incidence of Candida spp. in this group, up to 57.1%, (growth of single colonies), which, along with subjective manifestations (discomfort, dryness of the oral mucosa), is an objective symptom of oral dysbiosis. A clinical and microbiological study of the inventive dental elixir showed a high antimicrobial effect of this hygiene product. It was noted that with the use of a dental elixir, a persistent antimicrobial effect was observed, similar to the results obtained with the application of a solution of chlorhexidine bigluconate (CG) and elixirs containing CG as an active agent (Elixir “Lacalut”). But in contrast to chronic hepatitis C, with prolonged use of the inventive elixir, there was no change in tooth color and the appearance of dysbiosis in the oral cavity.

Assessment of the increase or reduction of the KPU index in children using dental elixirs showed that in the group using the Ideal dental elixir (prototype), there was an increase in the intensity of the K constant (caries) in the KPU index - by 19.4% per 12 months of use. In the group that used the claimed dental elixir, for the same period of time, the value of the constant "K", on the contrary, decreased by 37.6%. When using the developed dental elixir, an improvement in the hygienic state of the oral cavity is noted, which is confirmed by a decrease in the Silnes-Low index by an average of 45.8% compared with the initial state. Unlike existing analogues, the developed dental elixir has a cumulative positive effect, which is confirmed by statistically significant differences in relation to the cleansing and remineralizing effects of the elixir, which manifest themselves most clearly not earlier than 12 weeks after its use.

Thus, as the results of the study showed, the developed dental elixir for the prevention of dental caries has a pronounced antimicrobial, remineralizing, deodorizing and cleaning effect, does not suppress the saprophytic flora of the oral cavity, it can be used for a long time. This quality of the developed dental elixir allows you to use it as a means of hygiene both individually and as a mass means of prevention of dental caries, including as part of the regional "Dental Disease Prevention Programs".

INFORMATION SOURCES

1. Yakovleva V.I., Trofimova E.K., Davidovich T.P., Prosviryak G.P. Diagnosis, treatment and prevention of dental diseases // Minsk, Izd. "Higher School" - 1994., p.471.

2. Patent for the invention of the Russian Federation No. 2312657 C2 (OJSC Concern "KALINA").

3. Goncharova T.A. Encyclopedia of medicinal plants. Herbal treatment. In 2 vols. - M.: Publishing. House of SMEs, 1999. T.1, p. 80.

Claims (1)

Dental elixir for the prevention of dental caries, containing sodium fluoride, glycerin, components of medicinal plants, characterized in that as components of medicinal plants contains infusion of marsh rosemary, periwinkle, peppermint, heart-shaped linden, as well as Kislovodskaya healing water mineral water in the following the ratio of components, wt.%:
Glycerol 8-12 Infusion of marsh rosemary 4-6 Infusion of periwinkle small 2-4 Peppermint Infusion 6-8 Heart-shaped linden infusion 4-6 Sodium fluoride 0.001-0.005 Mineral water "Kislovodsk healing" Rest