UA85811C2 - Curative and prophylactic composition for oral cavity care - Google Patents

Abstract

The invention relates to stomatology and perfumery, more specifically to curative and prophylactic compositions for the oral cavity care. Said invention also relates to means for sanitation of the oral cavity and can be used for producing curative and prophylactic tooth pastes, gels, liquids for the oral cavity care and other compounds such as chewing gum, gel etc. The inventive composition containing active and inert components acceptable for oral use comprises 0.01-1mass % bromelaine and 1.5-20mass % xylitol in the form of active components. In the preferred embodiment, the bromelaine content ranges from 0.1 to 0.8 mass % and the xylitol within a range better than 2.2-18 mass %. In order to obtain a remineralization effect, the composition contains an anti-caries additive in a quantity of 0.05-3.0 mass %. In the preferred embodiment, the content of said additive ranges from 0.2 to 2.5 mass %. A calcium glycerophosphate and magnesium organic and inorganic salts are preferably used in the form of the mineral anti-caries additive. The use of sodium, potassium, calcium, and magnesium monophosphates in a quantity of 0.5-1.5 mass % in the form of the mineral anti-caries additive is also admissible. The optimal concentration ranges from 0.8 to 1.1 mass %.

Description

The invention relates to dentistry and the perfumery industry, namely therapeutic and preventive mixtures for the care of the oral cavity. The invention concerns means for maintaining oral hygiene and can be used for the preparation of therapeutic and preventive toothpastes, gels, liquids for oral care, as well as other mixtures, such as chewing gums, jellies, etc.

A well-known mixture for the prevention of dental and periodontal diseases, which includes sodium fluoride or sodium monofluorophosphate, sodium carboxymethylcellulose, titanium dioxide, sodium saccharinate, sorbitol or glycerin, silicon dioxide, food coloring, petroleum jelly, fragrance and water, chamomile extract, panthenol, calcium glycerophosphate , polyvinylpyrrolidone | VO C1 Me2188626, MPK7 Ab1K7/16, 20021.

A composition is known for remineralizing demineralized portions of teeth by treating them with a non-binding composition containing from about 10 to 20,905 xylitol and at least one fluoride ion supplying compound in a total amount sufficient to provide a fluoride ion concentration of 150-1800m .d., and the majority of such fluoride ions is provided by sodium fluoride (VO C1 Mo2092153, MPK7 Ab1K?7/16, 1997).

In the compositions according to this known solution, one or more organic surface-active agents are used to achieve improved moisturizing, foaming and preventive action, to facilitate the achievement of thorough and complete dispersion of the composition throughout the oral cavity. Organic surface-active material is anionic, nonionic or ampholytic in nature. A detergent is used as a surface-active agent, which gives this composition washing and foaming properties.

A variety of other materials may be incorporated into the oral preparations of the present invention, such as whitening agents, preservatives, silicones, chlorophyll compounds, other anti-calcification agents, and/or ammonia-containing materials such as urea, diammonium phosphate, and mixtures thereof.

The known solution provides a therapeutic and preventive agent in various forms: paste, gel, rinse aid, tablet, chewing composition.

In real life, it is not always possible to provide conditions for preventive effects, and known oral hygiene products often do not allow to have a positive effect on the processes taking place in the oral cavity, since the effectiveness of the additives used depends on the level of their availability to the tissues of the oral cavity. This is explained, in particular, by the fact that the biofilms that form on the surface of the teeth prevent the penetration of minerals to the enamel of the teeth, and the mucous membrane resorbs substances selectively.

In known solutions, the manifestation of the therapeutic and preventive effect, consisting in remineralization, is prevented by soft dental deposits, bacterial plaque on the surfaces of the teeth and on the soft tissues of the oral cavity. The components contained in the known mixtures do not ensure its effective removal for a long period of time, since there are no components whose function is the destruction of plaque and which are preserved during the time between repeated tooth brushing procedures. Accordingly, bacterial plaque contributes to the occurrence of dental and periodontal diseases, hinders the processes of mineral exchange in the oral cavity, both natural and caused by the special use of drugs to strengthen teeth.

Prepared in accordance with the invention, the therapeutic-prophylactic mixture for oral cavity care provides effective cleaning, which, in turn, opens the way for remineralization of tooth tissues. The mixture delays the formation of bacterial plaque on the teeth for at least 10-12 hours, increases enamel resistance and reduces periodontal inflammation, as the delay in the appearance of soft dental plaque on all surfaces of the teeth creates conditions for the saturation of the tooth enamel with the mineral components of saliva, and also helps reduce the microbial load on the periodontal tissue. At the same time, the mixture does not contain synthetic antibacterial drugs and coarse abrasives. The immediate task that was solved during the creation of the invention was the development of a highly effective mixture for the prevention of dental diseases of the teeth and soft tissues of the oral cavity, in which the synergistic drugs would enhance the effect of each other, providing a high therapeutic and preventive effect and achieving the above results.

Achieving results is ensured by the fact that the therapeutic and preventive mixture for oral care, which includes active and inert components acceptable for oral use, includes among the active components bromelain in the amount of 0.01-1 mass.95 and xylitol in the amount of 1.5- 20 mass. 9 c.

In the best version, the content of bromelain is in the range of 0.1-0.8wt.9o, and xylitol is in the range of 2.2-18wt.9b.

Bromelain is a group of high-molecular glycoproteins (N.A. Mashtsgeg, SMI 5 SeiI. Moi. Ge 5si. 58, 2001, pp. 1234-1245I), which is contained in the juice of fruits and plant stems. The group includes 8 proteases that provide hydrolysis proteins in a wide pH range of the environment (3.0-8.0). Bromelain was discovered in 1950 by Dr.

Heinicke.

The bromelain enzyme provides effective removal of bacterial plaque, has an anti-inflammatory and immunocorrective effect, which is associated with both the direct proteolytic action of the enzyme and the regulatory action of its utilization products (peptide fragments). The enzyme is actively resorbed by the mucous membrane throughout the gastrointestinal tract. Due to the presence of protease inhibitors, bromelain is safe for viable tissues.

Bromelain is used to relieve inflammatory processes in injuries, to prevent swelling of soft tissues, and to accelerate their recovery after injuries and other injuries. Oral use of bromelain helps reduce inflammatory processes and swelling, accelerates tissue repair processes. Due to the breakdown of non-viable proteins, bromelain accelerates the healing of wounds and trophic ulcers, contributing to their cleansing from necrotic masses. Bromelain has an immunocorrective effect, is used to relieve inflammatory processes in injuries, to prevent swelling of soft tissues, accelerates tissue repair processes, which are associated with the modification of vascular permeability and its ability to influence the metabolism of arachidonic acid.

In recent years, the role of bromelain in protection against viral infections, including influenza viruses (A and B) has been intensively studied (mapoma UM.T. 81).

Bromelain remains in the oral cavity for a long time, inhibiting the deposition of new plaque and improving the condition of the soft tissues of the oral cavity. This effect is achieved due to the effect of bromelain due to the action of two mechanisms: suppressing the formation of dental plaque, it reduces the microbial load on the gums; on the other hand, bromelain provides an anti-inflammatory effect.

The main function of xylitol is to modulate the permeability of tooth enamel. The mechanism of involvement of this substance in the biochemical exchange of streptococci is characterized as lethal synthesis, in connection with which xylitol reduces the activity of pathogenic microorganisms and improves the condition of the organs of the oral cavity, which contributes to the process of remineralization of teeth. |Gapgeg UM /Huiy! spem/pd dit apa depia! Sagiev.// IpE Oepi 9. 1995 Reb; 45 (1 5irri 1): 65-76). Xylitol increases the remineralizing potential, as it contributes to the inclusion of calcium in tooth enamel, suppresses the formation of dental plaque and reduces the cariogenic potential of microflora. In addition, being a sugar substitute, xylitol improves taste characteristics, and being a polyatomic alcohol, it performs the function of a moisture-retaining component.

The absence of soft dental deposits provides teeth with almost constant availability of mineral components contained in toothpaste and saliva. Providing long-term protection against the formation of dental plaque, the composition prevents the occurrence and development of major dental diseases.

The concept of remineralization is part of the ideology of the developed mixture. The remineralizing system is a combination of ingredients that allow you to saturate the enamel of healthy teeth and the initial foci of carious lesions with minerals.

To obtain a remineralizing effect, the mixture of active components contains an anti-caries mineral additive in the amount of 0.05-3.0 wt.9o. In the best version, the anti-caries mineral additive is contained in the amount of 0.2-2.5 wt.

As an anti-caries mineral additive, calcium glycerophosphate and inorganic or organic magnesium salt are used.

A tooth cleaned of plaque is most susceptible to the influence of calcium, phosphorus and magnesium, which can be introduced into the treatment and prevention mixture. Calcium and phosphorus are the main building blocks of tooth enamel and participate in exchange processes throughout a person's life.

The need for the supplement is due to the need of the teeth for these elements in case of caries and to an even greater extent in case of non-carious lesions of the teeth.

Non-carious lesions of the teeth are also most often associated with disorders of calcium metabolism and occur under adverse effects of an endogenous nature (disruption of the function of the thyroid gland, pancreas, gonads, diseases of the gastrointestinal tract, etc.), as well as under the influence of external adverse effects (ionizing radiation, daily prolonged - more than hours - work with a computer, the influence of production factors: acid vapors, metal dust and their combinations; a number of negative environmental influences) that cause a significant reduction of mineral components in the tissues of the teeth, and then damage in the form of caries , erosion, wedge-shaped defects, tooth wear.

In this regard, the local application of therapeutic and preventive mixtures containing phosphorus-calcium additives allows not only to prevent, but also to a certain extent to compensate for losses in the presence of the disease.

Calcium glycerophosphate is a source of active supply of phosphorus and calcium to the teeth and periodontal tissues, which accelerates mineralization processes and increases the anti-caries effect of the mixture, strengthens anabolic processes in the tissues.

Magnesium (from the composition of inorganic or organic salts) is a structural component of teeth and is included in the complex as a trace element, which is a cofactor for phosphatases, which ensure the inclusion of phosphates in the hard tissues of teeth. Glycerophosphate is hydrolyzed under the influence of phosphatases and, accordingly, its bioavailability increases.

Since the risk of tooth demineralization is significantly reduced in the absence of dense dental plaque, the mixture may not include fluorides. The presence of fluoride in the oral care mixture is relevant in a situation where soft dental plaque produces organic acids during the decomposition of easily fermentable carbohydrates. However, even under these conditions, after the end of the tooth enamel maturation process (in persons older than 20 years), the local effect of fluorides is practically not felt, which is expressed in a decrease in their effectiveness for the prevention of caries.

At the same time, the proposed mixture allows the use of sodium monofluorophosphate, potassium monofluorophosphate, calcium monofluorophosphate or magnesium monofluorophosphate in the amount of 0.5 - 1.5 wt.% as an anti-caries mineral additive. 95. The optimal concentration is 0.8 - 1.1 wt. 905.

To obtain a ready-made form of a therapeutic and preventive mixture for the care of the oral cavity in the form of a paste from among inert components, it contains, wt. 90: abrasive component 5-40 moisture-retaining and/or moisturizing component 5-70 gel-forming component 0.5-2.5 at least one surfactant 0.5-3.0 at least one flavoring agent 0.5-2 at least one preservative 0.01-0.5.

For a form in the form of a gel, from the number of inert components, the mixture contains, wt.9o: moisture-retaining and/or moisturizing component 5-70 gel-forming component 0.5-3.5 at least one surface-active substance 0.5-3.0 at least one taste filler 0.5-2 at least one preservative 0.01-0.5.

For the form of a liquid from among the inert components, the mixture contains, wt.9bo: moisturizing component 5-70 at least one surface-active substance 0.5-3.0 at least one flavor filler 0.5-2 water the rest.

For the form of chewing gum, among the inert components, the mixture contains, wt. 9o: polymer base - 20-30, at least one polyhydric alcohol - 45-60, at least one flavor filler - 0.5-2.

For a form in the form of a jelly, from among the inert components, the mixture contains, wt.9o: fruit sugar 20-50 at least one structure-forming agent 1-3 at least one flavor filler /-0.2-1.

When preparing a therapeutic-prophylactic mixture in the form of a paste, one or more substances selected from the group: calcium carbonate, dicalcium phosphate, silicon oxide, aluminum oxide, calcium pyrophosphate, sodium metaphosphate, polymethacrylate, magnesium carbonate can be used as an abrasive component.

When preparing a therapeutic-prophylactic mixture in the form of a paste or gel, one or more substances of the group: sorbitol, glycerin, polyethylene glycol can be used as a moisture-retaining component.

As a gel-forming component of a paste or gel, the following can be used: carboxymethyl cellulose, hydroxyethyl cellulose, xanthan gum, carrageenan, guar gum.

Among the preservatives, one or more substances from the following group can be used when preparing a paste or gel: methylparaben, propylparaben, butylparaben or their sodium salts, as well as phenoxyethanol, benzoic acid, sodium benzoate.

When preparing a therapeutic and preventive mixture in the form of a paste, gel or rinse, the following surface-active substances can be used: sodium lauryl sulfate, alkylamidobetaine, PEG-40 hydrogenated castor oil (polyoxyethylene (40) hydrogenated castor oil), polysorbate-20 ( polyoxyethylene-sorbitan-monolaurate).

In any of the listed forms, one or more substances from the following group can be used as a flavor filler: oils - peppermint, curly mint, citrus oils, eucalyptus, fir, pear, anise, clove, sage, menthol, carvone, anethole, methyl salicylate, sweeteners - sodium saccharin, lactose, maltose, aspartame, sodium cyclamate.

The possibility of making a therapeutic-prophylactic mixture for oral cavity care in the form of toothpaste is illustrated by the examples of mixtures given in Table 1.

Toothpaste is prepared in this way.

Weigh 2/3 of the required amount of glycerin, to which xanthan gum and calcium glycerophosphate are added.

Stir until a homogeneous mass is formed.

Heat the required amount of water in the measuring cup to 75-78" and load the water into the mixer, where sodium saccharinate, xylitol, parabens, magnesium chloride (or magnesium glycerophosphate in the case of example 3) are added. Mix until a clear solution is formed.

Table 1

Application 1, | Application 2, | Application 3,

Glycerin. 1120 | 8 | 5

And Sorbtol../:/ | - 1 16 | 20

Silicon dioxide 22 | 25 | - (Dicalcium phosphate//| /- 2 | - | 35 moodtorfosdet | o. monofluorophosphate 1.0 (Calcium glycerophosphate | 09 | 05 | 12 (Magnesium chloride. | 012 | - | 06

Magnesium glyceror phosphate - | 016 | -

Bromelain. | 04 | 09 | 05 (Sodium lauryl sulfate | 1.4 | - | 08 o Apkylamidobetaine. | - | 10 | 08

Polyvinylpyrrolidone 08 | 12 | -

Propylaraben./ | 008 | 01 | 0.06

Odushkai | 11 08 | 1

A suspension of components in glycerol is loaded into the resulting solution and mixed until a homogeneous mass is formed.

The mixture is vacuumed and stirred for 10 minutes until the air is completely removed from the mixture.

Then titanium dioxide is added to the mixer and vacuumed again with stirring for 10 minutes until the air is completely removed from the mixture.

After that, add silicon dioxide, vacuum again and stir for 30-40 minutes.

Next, the toothpaste is homogenized using a homogenizer pump for 15-20 minutes.

Next, the toothpaste is cooled while stirring to a temperature of 40-45.

Add bromelain to the remaining amount of glycerin and mix until a homogeneous mass is formed.

At the final stage, a suspension of bromelain in 1/3 of glycerin is loaded into the mixer and mixed until a homogeneous mass is formed within 20 minutes.

Next, perfume and sodium lauryl sulfate (or amidopropyl betaine in the case of example 1) are loaded and mixed for 30 minutes until a homogeneous mass is obtained.

Prepared toothpaste is packaged in tubes made of polymer material.

The possibility of making a therapeutic and preventive mixture for the care of the oral cavity in the form of a dental gel is illustrated by the examples of mixtures given in Table 2.

Table 2

Application 1, | Application 2, | Application 3,

Isorbtol..///////// | 77-15

And Xyllol.//// | 8 | 10 | 80 mokotorfosvvt | 01 ov monofluorophosphate picrophosrate 012 | le | 05 glycerophosphate 12 1.8 0.5 (Magic chloride./// | 018 | - | oleg

Magnesium glycerophosphate. /- | 02 | - (Camedguara | 009 | 008 | 006

Pes ov ov | with

Hydrogenated castor oil 12

Sodium saccharin./// | - | 006 | from /

And Odushka | 04 | 06 | 05

The mixture in the form of a gel is prepared as follows.

The required amount of water is heated in the measuring device - dispenser to 75-827"C, then water is loaded into the mixer, where methylparaben, magnesium chloride (or magnesium glycerophosphate in the case of example 2), xylitol, sodium saccharin, sodium monofluorophosphate (in the case of example 3) are added. , sorbitol (in the case of example 2).

The mixture is stirred until a clear solution is formed within 20 minutes.

A suspension of bromelain, hydroxyethyl cellulose, guar gum, calcium glycerophosphate in glycerol is prepared separately.

The aqueous solution of the components is cooled to 50-557C, a suspension with bromelain is added to it and mixed until a homogeneous mass is formed within 30 minutes.

Separately, PEG-40 hydrogenated castor oil is heated to 50-557C, perfume is added and mixed for a few minutes until a homogeneous mixture is formed.

The resulting mixture is added to the solution of components obtained at the first stage and stirred for 20-30 minutes until a homogeneous gel is formed.

The obtained gel is cooled with stirring to a temperature of 20 - 257C and packaged in tubes made of polymer material.

The possibility of making a therapeutic and preventive agent for the care of the oral cavity in the form of a rinse is illustrated by examples of mixtures given in Table 3.

The mixture in the form of a rinse is prepared as follows.

The required amount of water is heated in the measuring device - dispenser to 75-82"C and poured into the mixer, where sodium benzoate, benzoic acid, calcium glycerophosphate are added. The mixture is stirred until a transparent solution is formed within 30-40 minutes.

Further, magnesium chloride (or magnesium glycerophosphate in the case of example 2), xylitol, polyvinylpyrrolidone, sodium saccharin, sodium monofluorophosphate (in the case of example 3), sorbitol (in the case of examples 1 and 3) are added to the mixture at a temperature of 70-757C and mixed for 30- 40 minutes.

Table C

Application 1, | Application 2, | Application 3, (Glycerin. | 2 | - | z

ISorotol..///////(/О| 4 | - | 3

Propylene glycol.////// | - | 8 | - (Hydroxyethyl cellulose | 0.05 | 0.06 | 0.04

Sodium monofluorophosphate 1-1 oz (Calcium glycerophosphate! od | 05 | 0.06 (Magnesium chloride. | 004 | - | 002 (Magnesium glycerophosphate | - | 008 | - (Sodium lauryl sulfate | - | - | 06 o Apkylamidobetaine.i | 06 | 06 | - ( Styroaslia. | 12 | oyu | ov castor oil 12 (Benzoic acid | od | 012 | 05

Sodium saccharin./ | from | 008 | 006

Separately prepare a suspension of bromelain, hydroxyethyl cellulose in glycerol (or propylene glycol in the case of example 2), which is added to the mixture cooled to 50-557C, obtained in the first stage. The mixture is stirred until a clear solution is formed within 20 minutes.

Separately, PEG-40 hydrogenated castor oil is heated to 50-557C, perfume is added, mixed to form a homogeneous mixture for 10 minutes and added to the mixture obtained at the previous stage at a temperature of 50-557C. The mixture is stirred until a clear solution is obtained for 20 minutes.

Alkylamidobetaine (or sodium lauryl sulfate in the case of example 3) is added, stirred until a clear solution is formed for 20 minutes, which is cooled while stirring to a temperature of 20-257C and poured into bottles.

The possibility of making therapeutic and preventive chewing gum is illustrated by examples of mixtures given in Table 4.

The mixture in the form of chewing gum is prepared as follows.

The base is melted at a temperature of 90 - 957"С, reloaded into a mixer with built-in 2-type stirrers and cooled to a temperature of 80"С.

Load lecithin, calcium carbonate, magnesium chloride, calcium glycerophosphate and mix for 10 minutes, add sorbitol, which does not crystallize, and mix for 10 minutes, add mannitol and xylitol, mix for 10 minutes, add crystalline sorbitol, sodium saccharin, starch hydrolyzate, mix for minutes.

Table 4

Application 1, IApp. 2, App. 3,

Manthol//////7777777 | 15 | - | 10

Odduskai gg | 1 | 06 | 06 32

After that, the mixture is cooled to a temperature of 55"C, perfume, prepared suspension of bromelain in glycerol is added and stirred for 20 minutes.

The mass is unloaded, rolled, cut into plates or cubes of the required size, dried to the required humidity and packed.

The possibility of making therapeutic and preventive jelly (marmalade) is illustrated by an example of the mixture given in Table 5.

The mixture in the form of jelly (marmalade) is prepared as follows.

During the boiling of marmalade masses, excess moisture is removed from the sugar-apple mixture at a temperature of 105-107"C. The sugar-apple mixture has an initial moisture content of more than 4595, sugar-molasses-agar syrup 30-3395. The final moisture content of the marmalade mass ranges from 24-3395 and it depends on the recipe and type of products.Sugar-molasses-agar syrup is boiled in a spiral digester to a moisture content of 27-2895, xylitol is added, mixed and cooled to a temperature of 40-5076.

Table 5

Aromatic substances, calcium glycerophosphate, magnesium chloride, as well as a suspension of bromelain in glycerin are added to the cooled syrup.

The syrup, after it has passed through the cooler, is gelled into molds. The molds stand up, the jelly is extracted from them, cut into pieces and packed.

The effectiveness of therapeutic and preventive toothpastes manufactured according to the invention was tested on a group of volunteers in order to evaluate the hygienic and anti-inflammatory effect.

Mixtures according to examples 1-3 from table 6 were used, provided that the teeth were brushed twice a day for 2-3 minutes.

Clinical studies of the toothpaste included the study of the cleansing effect and anti-inflammatory effect, the assessment of possible allergenic and local irritant effects.

The study was conducted for three months according to the principle of the blind method, that is, when the dentist-epidemiologist conducting the dental examination did not know to which group this patient belonged.

10 people aged 27 to 42 participated in the clinical study.

Table 6

Application 1, | App. 2, IPApp. 3, (Natryusacharin.// | od | 02 | 03

Odushkai | 07 | 08 | 10

Bromelain. | from | 03 | 07 (Sodium lauryl sulfate | - | 13 | 14

Alkylamidobetaine.i | 12 | - | - (Calcium glycerophosphate | 06 | 08 | 1 (Magnesium chloride./// | 008 | 012 | - about Magnesium glycerophosphate | - | - | 016

Before the start of the study, the dental status of all participants was assessed. The conducted clinical study consisted of 4 series of toothpaste testing. Each series included a previous two-week use of the same toothpaste of the type "Colgate - maximum protection against caries" and a 14-week testing of the tested samples of toothpastes, which were given to the subjects in a random sequence.

The examination consisted of: - examination of hard and soft tissues of the oral cavity: lips, tongue, hard and soft palate, teeth and gums; - determination of the hygienic state of the oral cavity according to the PNR index (Roazpadieu A.S., NaiIieu R., 1968); - assessment of periodontal tissue condition using the gingivitis index (1) | oye N., 15 5i/pev5 .,1963)|, which indicates the localization and severity of gingivitis.

The examination was carried out 5-6 hours after brushing the teeth.

Changes in the hygiene index in the study participants are given in Table 7

Table 7

Mixture numbers

The initial state et imvume| 1zvho2v | il, (Met 1.45:-0.16 | 1.36--0.26 | 1.12--0.21

The study of toothpaste with bromelain 0.790 showed that the initial value of the hygienic index of PHP in the study participants was 2.60540.53. This value corresponds to an unsatisfactory level of oral hygiene. The data of subsequent examinations revealed a reliable improvement in the hygienic condition of the oral cavity in the study participants, and by the end of the study, the PNR index decreased to 1.12520.21 (p«0.02). The cleaning efficiency of the toothpaste during the period of use was 56.995.

A similar trend was observed when studying the cleansing properties of toothpaste containing bromelain 0.395. During its use, the hygienic index significantly decreased from 2.62520.42 to 1.36:20.26 (p«0.02). The cleaning efficiency of this sample was 48.1905.

A study of the cleaning properties of a paste containing 0.195 bromelain revealed that the values of the hygiene index also decreased, but to a lesser extent. This indicator was 40.3905.

Changes in the gingivitis index (GI) in the study participants are shown in Table 8.

Table 8

Initial day (Melu | oliyula olikhole surroundings, day (Met 0.7920.14 0.71-50.12 | 0.92520.14

The initial condition of the periodontal tissues in the subjects who participated in the testing corresponded to gingivitis of mild and moderate severity according to the IS index. The value of the gingivitis index during the initial examinations: 1.1320.12 - in the first series, 1.16:20.21 - in the second series and 1.11250.11 in the third series. Reduction of inflammatory phenomena in periodontal tissues amounted to 18.695 during the period of use of toothpaste with the maximum concentration of bromelain; 38,895 during the period of using toothpaste with a bromelain concentration of 0.395; 28.895, respectively, during the period of application of the paste containing 0.195 bromelain.

According to the subjective assessment of the majority of the subjects, during the period of using the toothpaste of the proposed mixture, a noticeable delay in the appearance of visible plaque on the front teeth was observed, as well as a long-term preservation of the smoothness of the teeth on the lingual surfaces (according to some reports, a day or more). In addition, individuals who regularly flossed the lateral surfaces of their teeth noted a sharp decrease in the amount of dental plaque on the lateral areas of the teeth when using toothpastes with a concentration of bromelain of 0.395 and 0.795, compared to a paste containing bromelain at a concentration of 0.195 and "Colgate - maximum protection against caries" paste.

The fact that during the washing period there was a significant deterioration of both the hygienic indices and the indices characterizing the state of the periodontium deserves special attention.

The impact of the toothpaste of the proposed mixture on the state of the enamel of the teeth was evaluated in comparison with Viepa-a-Maid toothpaste, which contains sodium fluoride in a concentration of 0.32190 (0.1595 E") by the acid biopsy method of the enamel. The study was carried out for one month, control the indicator, which was tested according to the following methodology, was carried out every week. Samples were taken from the intact surfaces of the front teeth. Each group of subjects included 30 people from among 17 typical consumers of the product.

The acid biopsy method of enamel according to V.K. Leontiev, V.A. Distel, which includes applying a strictly defined amount of demineralizing liquid to the enamel, taking it after a certain time interval and then determining the amount of calcium in the acid demineralization, makes it possible to determine the rate of acid demineralization enamel solubility.

Quantitative analysis of the content in μg/l of calcium and phosphorus in an acid biopsy is carried out by the spectrophotometry method.

The test results are shown in Table 9.

Table 9

Toothpaste

SHE tey

Са 113.25,|Са 113.25;| Ca 91.2; to St Rbo | vavo p 50.5 p 50.8 p 42.5

11111111 RA | inRavz | Slave

R 44.9 R 45.7 R 392

Reduction of Ca 20.79; | Са 20.53; | Ca 11.95;

The results of an acid biopsy of the enamel indicate a strengthening of the tooth enamel structure. A decrease in the output of calcium and phosphorus in the biopsy indicates an increase in acid resistance and chemoresistance of enamel, which indicates an increase in the strength of the latter. During the four weeks of the study, as a result of using the toothpaste of the proposed composition, the output of calcium under the influence of acid decreased by 20.5395 at a bromelain concentration of 0.390, by 20.7195 at a bromelain concentration of 0.195, while a similar indicator in the subjects who brushed their teeth with Viepa-a-Mei paste was 11.95 95, which indicates the high remineralizing potential of the toothpaste of the proposed composition.

Claims (19)

1. Therapeutic-prophylactic mixture for oral care, which contains active and inert components acceptable for oral use, which is distinguished by the fact that as active components it contains bromelain in the amount of 0.01-1 wt. and xylitol in the amount of 1.5-20 wt. 90, which provide an anti-plaque, anti-inflammatory effect, delay the formation of dental plaque and improve the quality of remineralization, as well as an anti-caries mineral additive in the amount of 0.05-3.0 wt. 90. 2. The mixture according to claim 1, which differs in that the content of bromelain is 0.1-0.8 wt. 90. 3. The mixture according to claim 1, which differs in that the content of xylitol is 2.2-18 wt. 95. 4. The mixture according to claim 1, which differs in that the content of the anti-caries mineral additive is 0.2-2.5 wt. 90. 5. The mixture according to item I, which differs in that it contains calcium glycerophosphate and inorganic or organic magnesium salt as an anti-caries mineral additive. b. The mixture according to item I, which differs in that it contains sodium monofluorophosphate, potassium monofluorophosphate, calcium monofluorophosphate or magnesium monofluorophosphate in the amount of 0.5-1.5 wt. as an anti-caries mineral additive. 90. 7. The mixture according to item I, which differs in that it contains sodium monofluorophosphate, potassium monofluorophosphate, calcium monofluorophosphate or magnesium monofluorophosphate in the amount of 0.8-1.1 wt. as an anti-caries mineral additive. 90. 8. The mixture according to claim 1, which differs in that, if the mixture is a paste, among the inert components it contains, wt. 20: abrasive component 5-40 moisturizing component 5-70 gelling component 0.5-2.5 at least one surfactant 0.5-3.0 at least one flavor filler 0.5-2 at least one preservative 0.01- 0.5. 9. The mixture according to claim 1, which differs in that, if the mixture is a gel, among the inert components it contains, wt. Xo: moisturizing component 5-70 gelling component 0.5-2.5 at least one surfactant /--0.5-3 at least one flavor filler 0.5-2 at least one preservative 0.01-0.5. 10. The mixture according to claim 1, which differs in that, if the mixture is a liquid, among the inert components it contains, wt. 20: humectant 5-70 at least one surfactant /--0.5-3 at least one flavoring agent 0.5-2 water the rest. 11. The mixture according to claim 1, which differs in that if the mixture is a chewing gum, among the inert components it contains, wt. 90: polymer base 20-30 at least one polyhydric alcohol 45-60 at least one flavor filler //-0.5-2. 12. The mixture according to claim 1, which differs in that if the mixture is a jelly, among the inert components it contains, wt. 20: fruit sugar 20-50 at least one structuring agent 1-3 at least one flavor filler /-0.2-1. 13. The mixture according to claim 1, which differs in that if the mixture is a lozenge, among the inert components it contains, wt. 20: at least one polyhydric alcohol 40-60 at least one structuring agent 2-15 at least one flavor filler 0.5-2. 14. The mixture according to claim 8, which is characterized by the fact that as an abrasive component it contains one or more substances selected from the group that includes: calcium carbonate, dicalcium phosphate, silicon oxide, aluminum oxide, calcium pyrophosphate, sodium metaphosphate, polymethacrylate, magnesium carbonate. 15. The mixture according to claim 8 or 9, which is characterized by the fact that as a moisturizing component it contains one or more substances selected from the group including: sorbitol, glycerin, polyethylene glycol. 16. The mixture according to claim 8 or 9, which is characterized by the fact that one or more substances selected from the group including: carboxymethyl cellulose, hydroxyethyl cellulose, xanthan gum, carrageenan, guar gum are selected as a gelling component. 17. The mixture according to claim 8 or 9 or 10, which differs in that as a surface-active substance it contains one or more substances selected from the group that includes: sodium lauryl sulfate, alkylamidobetaine, PEG-40 hydrogenated castor oil, polysorbate 20. 18. A mixture according to any one of claims 8-13, which is characterized in that as a flavor filler it contains one or more substances selected from the group including: peppermint oil, spearmint oil, sage oil, oil pear, citrus, eucalyptus, fir, anise, clove, menthol, carvone, anethole, methyl salicylate, sweetener - sodium saccharinate, lactose, maltose, aspartame, sodium cyclamate. 19. The mixture according to claim 8 or 9, which is characterized by the fact that as preservatives it contains one or more substances selected from the group including: methylparaben, propylparaben, butylparaben or their sodium salts, phenoxyethanol, benzoic acid, sodium benzoate.