RU2711246C1 - Therapeutic-and-preventive toothpaste - Google Patents

Abstract

FIELD: hygiene.SUBSTANCE: invention refers to dental cleansers, namely to therapeutic toothpaste. Disclosed toothpaste comprises an abrasive component – titanium dioxide; binder – carboxymethyl cellulose (CMC), a humectant – glycerin, a sweetener – sodium saccharinate; calcium glycerophosphate, sodium fluoride, emulsifier – polyethylene glycol PEG-8, sodium salt of methyl ether of para-hydroxybenzoic acid and sodium salt of propyl ether of para-hydroxybenzoic acid as a preserving agent; a mixture of essential oils of chamomile, sage and rose; surfactant – sodium lauroyl sarcosinate; as well as 20–30 % water-and-alcohol extracts of cypress and lavender, sodium bicarbonate (baking soda), "Biol" preparation – porous solution (squeezing) of mud of sulphide sludge of Saky lake; dried and finely disperse substrate in form of mother-of-pearl and Black Sea algae spirulina, laminaria, zoster, obtained by sampling biomaterial of muscular stomachs and endodermal sinus with pallid fluid of Black Sea mussel (Mytilusgalloprovincialis) and Black Sea oyster (Crassostreagigas); additional sweetening agent – xylitol, food pink Ponso, as drinking water – natural therapeutic and table water-carbonate-chloride low-mineralized sodium water of the Saky deposit of mineral underground water, with the following ratio of ingredients, wt%: titanium dioxide 4.70–5.65; carboxymethyl cellulose 1.86–2.80; glycerol 9.20–9.82; sodium saccharinate 0.15–0.25; calcium glycerophosphate 16.18–18.67; sodium fluoride 0.07–0.11; polyethylene glycol PEG-8 4.46–5.04; sodium salt of methyl ether of para-hydroxybenzoic acid 0.23–0.34; sodium salt of propyl ether of para-hydroxybenzoic acid 0.08–0.14; sodium bicarbonate 11.84–12.63; sodium lauroylsarcosinate 0.84–1.20; preparation "Biol" – pore solution (squeezing) of mud of sulphide sludge of Saky lake 8.08–9.05; substrate from Black Sea mollusks 7.62–8.04; xylolol 5.32–5.91; food pink coloring agent Ponso 0.01–0.01; water-alcohol extract of cyper 1.08–1.25; aqueous-alcoholic lavender extract 0.87–1.02; essential oil of sage – 0.58–0.67; camomile essential oil 0.70–0.81; rose essential oil 0.35–0.41; drinking water – low-mineralized hydrocarbonate-chloride low-mineralized medical salt table of Saky deposit of mineral underground water 19.37–22.59. It may be recommended for persons of 7 years old without restrictions, with inflammatory diseases of oral cavity, dental caries, hyperesthesia for daily two-time use.EFFECT: paste composition provides multicomplex action on periodontium tissues, oral mucosa, solid dental tissues, particularly anti-inflammatory, antibacterial, reparative, immunomodulating, mineralizing action.1 cl

Description

The invention relates to means for brushing teeth, namely to preventive toothpastes.

The closest in composition to the claimed therapeutic and prophylactic toothpaste is the prophylactic toothpaste adopted by the closest analogue described in RF patent No. 2455975 (A61K 8/55, A61K 8/41, A61K 8/97, A61K 8/21, A61K 8 / 24, A61K 8/60, A61Q 11/00; 2012). Toothpaste contains:

- abrasive component (chemically precipitated chalk, and / or dicalcium phosphate, dihydrate, or titanium dioxide, and / or silicon dioxide - 2-70 wt.%;

- a binder (sodium carboxymethyl cellulose or methyl cellulose) - 0.5-10 wt. %;

- humidifiers (glycerin, and / or sorbitol, or polyethylene glycol, or propylene glycol) - 0.1-60 wt. %;

- preservatives (sodium benzoate, and / or thymol, and / or ethyl alcohol) - 0.01-0.5 wt. %;

- biological additives (saccharin or maltose, or aspartame, or sodium cyclamate, essential oils of plants or aqueous-alcoholic extracts of medicinal plants) - 0.01-4 wt. %;

- functional additives (calcium glycerophosphate, soluble calcium salts, sodium fluoride) - 0.01-4 wt. %;

- flavors (peppermint flavor, or peppermint oil, or menthol) - 0.01-1.5 wt. %;

- betaine surfactants (alkyl betaine selected from the group: decyl betaine or 2- (N-decyl-N, N-dimethylammonium) acetate, cocobetaine or 2- (N-coc-N, N-dimethylammonium) acetate, myristyl betaine, palmityl betaine , lauryl betaine, cetyl betaine, stearyl betaine; or amidobetaine selected from the group: cocoamidoethyl betaine, cocoamidopropyl betaine, laurylamidopropyl betaine) - 0.2-10 wt. %;

- emulsifier lecithin;

- water - the rest.

The technical result of the invention is to increase the therapeutic and prophylactic properties of toothpaste due to the multicomplex effect of paste ingredients that increase anti-inflammatory, antibacterial, pronounced reparative, immunomodulatory effects on periodontal tissues, oral mucosa, hard tissues of teeth by increasing the mineralization and resistance of enamel.

Signs of the closest analogue, which coincides with the essential features of the invention, is the presence in the therapeutic toothpaste of an abrasive component - titanium dioxide; a binder - CMC carboxymethyl cellulose (the so-called cellulose gum), a moisturizer - glycerin, preservatives, a sweetener - saccharin (sodium saccharinate); essential oils of plants, aqueous-alcoholic extracts of plants, calcium glycerophosphate, sodium fluoride, surfactants; emulsifier, drinking water.

The reasons that impede the achievement of the indicated technical result when using the closest analogue are its insufficient therapeutic effect to prevent hyperesthesia of hard tooth tissues, periodontal tissues, and oral mucosa due to the lack of a multicomplex effect of paste ingredients on the oral cavity.

The technical task of the invention is to expand the arsenal of compositions of therapeutic and prophylactic agents that provide multidirectional prophylactic and therapeutic effect.

The problem is solved in that the therapeutic and prophylactic toothpaste, including the abrasive component - titanium dioxide; a binder is carboxymethyl cellulose (CMC), a humectant is glycerin, preservatives, a sweetener is sodium saccharin; calcium glycerophosphate, sodium fluoride, surfactants; an emulsifier, essential oils, drinking water, according to the invention, as an emulsifier contains PEG-8 polyethylene glycol, as a preservative, sodium salt of methyl para-hydroxybenzoic acid and sodium salt of propyl ether of para-hydroxybenzoic acid; as essential oils - a mixture of essential oils of chamomile, sage and rose; as water-alcohol extracts of plants - 20-30% water-alcohol extracts of cypress and lavender; as surface-active substances - sodium lauroyl sarcosinate; additionally contains sodium bicarbonate (baking soda), the Biol preparation - a pore solution (squeezing) of mud from sludge of sulphide of Saki Lake; substrate from the Black Sea mollusks: dried and finely divided substrate in the form of mother of pearl and Black Sea algae, spirulina, kelp, zoster, obtained by taking biomaterial from muscular stomachs and endoderm sinus with pallial fluid of the Black Sea mussel Mytilus granulophyllus crust) food coloring pink Ponceau, as drinking water - natural medicinal-table hydrocarbonate-chloride-sodium low-mineralized water Saks mineral deposits of groundwater,

in the following ratio of ingredients, mass%:

titanium dioxide 4.70-5.65; carboxymethyl cellulose (CMC) 1.86-2.80; glycerol 9.20-9.82; sodium saccharinate 0.15-0.25; calcium glycerophosphate 16.18-18.67; sodium fluoride 0.07-0.11; polyethylene glycol PEG-8 4.46-5.04; para-hydroxybenzoic acid methyl ester sodium salt 0.23-0.34; para-hydroxybenzoic acid propyl ester sodium salt 0.08-0.14; sodium bicarbonate 11.84-12.63; sodium lauroyl sarcosinate 0.84-1.20; “Biol” preparation - pore solution (wringing) of mud of sulphide sulphide of Lake Saki 8.08-9.05; substrate from the Black Sea mollusks: dried and finely divided substrate in the form of mother of pearl and Black Sea algae, spirulina, kelp, zoster, obtained by taking biomaterial from muscular stomachs and endoderm sinus with the pallial fluid of the Black Sea mussel Mytilus eryngreagin , 04; xylitol 5.32-5.91; food color pink Ponceau 0.01-0.01; water-alcohol extract of cypress 1.08-1.25; water-alcohol extract of lavender 0.87-1.02; sage essential oil 0.58-0.67; chamomile essential oil 0.70-0.81; rose essential oil 0.35-0.41:

Drinking water. Medical-canteen low-mineralized hydrocarbonate-sodium chloride Saki deposit of mineral underground water 19.37-22.59.

Between the totality of the essential features of the invention and the achieved technical result, there is the following causal relationship. The combination of these essential features of the invention is a necessary and sufficient condition for achieving a technical result. Improving the therapeutic properties of toothpaste is provided by a combination of features of the invention.

Toothpaste is a mixture of powder particles in liquid form, in which the powder particles are abrasive substances, builders and other fillers, insoluble in the dispersion medium. Dispersion medium - a gel containing bioactive additives, surfactants, flavors and other components. Physico-chemical parameters of domestic toothpastes comply with GOST 7983-82 “Toothpastes. General technical requirements. " There is an international standard ISO 11609-95 "Dentistry, toothpastes." The composition of toothpastes includes: water; abrasive substances; binding, gelling agents; detergents (foaming agents); humidifiers; perfumes; preservative antiseptics; dyes; flavoring additives (sweeteners); active agents.

- сладкий). Применяют в составе зубных паст для получения пластичной, однородной массы, которая легко выдавливается из тубы. Глицерин способствует сохранению влаги в пасте при хранении, увеличивает температуру замерзания, усиливает стабильность образующейся при чистке зубов пены, улучшает вкусовые качества пасты.Glycerin is a colorless, viscous, very hygroscopic liquid. Glycerin is mixed with water in any proportions. Sweet in taste, which is why it got its name (dr. Greek.

- sweet). They are used as part of toothpastes to produce a plastic, homogeneous mass that is easily squeezed out of the tube. Glycerin helps to preserve moisture in the paste during storage, increases the freezing temperature, enhances the stability of the foam formed during brushing, and improves the taste of the paste.

Titanium dioxide TiO ₂ (titanium dioxide) in toothpaste is used as an abrasive to clean, polish the surface of the tooth, and also to ensure the viscosity and whiteness of the paste. Official science has established that titanium dioxide is bioinert, that is, this component is neutral in relation to the human body when taken orally and when applied to the oral mucosa.

Saccharin (sodium saccharinate, imidorto-sulfobenzoic acid sodium salt, 2-sulfobenzoic acid imide, ortho-sulfobenzimide) are colorless crystals of a sweet taste, sparingly soluble in water. Sodium saccharinate is a sodium hydrate crystalline salt, which is 300-500 times sweeter than sugar. It is not absorbed by the body (excreted in the urine). Used in toothpaste as a sweetener.

Xylitol is a natural sweetener found in berries and fruits, for example, in plums, strawberries, raspberries, as well as in birch wood. Each time during the meal, bacteria living in the mouth process sugar, which is in the food, producing acids. These acids destroy the enamel, subsequently cause further destruction of the tooth tissue, leading to the development, occurrence and progression of caries. Xylitol blocks bacteria from producing acids that cause tooth decay. The bacteria mentioned above are not able to convert xylitol to acids. In addition, xylitol inhibits the growth of bacteria, not allowing pathogens to linger on the surface of the teeth, thereby preventing the process of their damage. Xylitol helps to stop the progression of the carious process of tooth hard tissues - studies have shown that minerals such as calcium, phosphate and fluoride are better absorbed by enamel in the presence of xylitol.

Sodium bicarbonate (baking soda), sodium bicarbonate - an acid salt of carbonic acid. It is a white crystalline powder. It is used in the food industry, in cooking, in medicine. Bicarbonate has the ability to reduce the acidity of plaque and prevent tooth problems. Moreover, it can inhibit plaque formation on teeth and increase calcium absorption by tooth enamel.

Cellulose gum is the conventional name for methyl cellulose - cellulose ether and methanol. White amorphous powder, soluble in cold water, in some organic acids, alcohols and ethers. Insoluble in most organic solvents. Obtained by treating cotton or wood pulp with an aqueous solution of NaOH, the cellulose swells, and a small amount of its low molecular weight part (1.5-7.0% of the total mass) passes into the solution. The treatment product, called alkaline cellulose, is methylated with chloromethane in an autoclave at a pressure of 1.2-2.0 MPa. In most cases, methylcellulose is used to thicken the aqueous medium. Methyl cellulose allows water-insoluble substances to be transferred in an aqueous medium to a stable finely divided state, since it forms hydrophilic monomolecular protective layers around individual particles. Carboxymethyl cellulose is a real find for humanity. It is inexpensive to manufacture, completely non-toxic, chemically neutral and has many useful properties, and therefore is widely used in medicine, pharmaceutical, chemical and food industries. Carboxymethyl cellulose is a substance derived from cellulose. In chemical terms, it is an ether of cellulose and glycolic acid, an acid polysaccharide. Externally, it is a light or light beige crystalline powder, odorless and tasteless. It is highly soluble in water, absorbs it and forms a viscous gel-like solution. It is this property, combined with non-toxicity, that is the most valuable in it for a variety of industries, including pharmaceuticals. In practice, the carboxymethyl cellulose sodium salt is more often used. The substance is not natural (in the sense that it does not occur in nature), but is made from natural ingredients.

Sodium fluoride is an inorganic compound with the chemical formula NaF - a white crystalline substance. Sodium fluoride and fluorapatite formed from it are used to strengthen tooth enamel, which itself contains fluorapatite. Sodium fluoride in toothpaste easily and quickly dissociates into ions with the release of active ionized fluoride. It has high remineralizing activity, reduces tissue hyperesthesia, due to which there is a quick strengthening of the teeth. It has a pronounced carioprotective effect, significantly reduces the formation of soft plaque (biofilm), tartar.

An emulsifier is a surfactant that provides emulsions and stabilizes a mixture of substances that are not miscible in vivo. Emulsifiers accumulate at the boundary of two liquids and reduce the tension between them, that is, this is an auxiliary substance that provides the creation of an emulsion. They largely determine the texture and texture of the final product, as well as its ductility and viscosity. In order for the paste to be stable, the ratio of ingredients to water must be observed. Also, the amount of emulsifier is very important, and the formation of an emulsion requires mechanical action (mixing or whipping).

Polyethylene glycols (or PEGs) are a whole group of polymers that differ in molecular weight, but which have common chemical properties. These substances are very different in physical parameters - from a transparent liquid to a dense crystal. Such artificially synthesized polyhydric alcohols are abbreviated as PEG (PEG). Polyethylene glycols are used as food additives. These substances are part of soft drinks, artificial sweeteners and chewing gum. Fruit is also processed with polyethylene glycol in order to increase shelf life. In medicine, PEG is used to make tablets, suppositories, and ointments. Using these polymers, complex genetic analyzes are performed. Polyethylene glycol is part of many lotions, creams, shampoos, shaving gels, deodorants, toothpastes.

Sodium salt of parahydroxybenzoic acid methyl ester is also known as a food supplement under identification number E219. The substance is a derivative of benzoic acid. In the natural environment E219 can be found in various fruits, mushrooms, berries, clove flower seeds. The substance is also found in products of fermented milk origin (yogurt). One of the most valuable properties of a preservative is its ability to slow down the growth and reproduction of bacterial and fungal strains.

Sodium salt of para-hydroxybenzoic acid propyl ether is known as a dietary supplement under identification number E217. It is widely used in the food industry, mainly as a preservative. In appearance, the additive looks like a crystalline powder of white color, while it is readily soluble in water. Basically, the additive E217 has a pronounced antimicrobial activity, has the properties of stopping the growth of bacteria, mold and various fungi. This additive is widely used as a preservative in the manufacture of various cosmetics such as shampoos, lotions, creams, bath products and many others. In the food industry, the additive E217 is used in the same way as the preservative E216 in confectionery and meat-containing products.

Sodium lauryl sarcosinate is an anionic surfactant, which is an amphiphilic substance used as a foaming agent in the manufacture of detergents, toothpaste, and cosmetics. Sodium lauryl sarcosinate - obtained from sarcosine (methylglycine). It is a surface active substance (surfactant). Non-flammable, in aqueous solutions forms a stable foam. The color of an aqueous solution of sodium lauryl sarcosinate is clear to yellow. It is used as a detergent in industry, pharmacology, cosmetology. Sodium lauryl sarcosinate is the most common surfactant, it is included in various cleaning formulations, for example, in toothpastes, shampoos, detergents.

Food color synthetic water-soluble pink Ponceau 4R, additive under identification number E124 manufactured by Mumbai, India.

The preparation “Biol” is a natural balneocosmetic product manufactured in accordance with TU 9158-004-00809517-2015 “Pore solution (wringing) of mud of sulphide sulphide of Saki Lake”, Declaration of Conformity TP ТС 009/2011 EAEU N RU Д-RU.АД34.B. 01358. The drug "Biol" - a pore solution (wringing) of mud of sulphide sulphide of Lake Saki provides an active organomineral basis of toothpaste. The mineral and bioactive components of peloids have healing properties, since the mud preparation contains a balanced complex of mineral salts, trace elements and natural biostimulants, including: sodium, potassium, magnesium, calcium, iron salts, iodine and bromine ions, boric and silicic acid, aspartic acid, humic and a number of fatty acids, lipids and phospholipids, caroticoids, amino acids, steroids, hormone-like substances, vitamins (A, B ₁ B ₆ , B ₁₂ , C, D, E, F, PP), other vital elements for human health. Mineral and organic substances contained in the preparation, microelements and biostimulants have a beneficial effect on the stimulation of regenerative processes in tissues, have anti-inflammatory and antiseptic effects. By activating peripheral blood circulation, saturating the cells with necessary substances and energy of natural compounds, the drug improves the condition of periodontium, oral mucosa, and tooth resistance to caries when rinsing with a warm diluted preparation, gaining and keeping in the mouth in small portions for 3-5 minutes several times a day. GUNPP RK “CRIMEAN GRES” is produced according to TU 58-004-00809517-2015,296500 RF, Republic of Crimea, Saki, ul. Resort, 4, tel. +7 (36563) 3-13-24, 2-62-41, www.sakilake.com, e-mail: station@sakilake.com.

To obtain a substrate from the Black Sea mollusks, use the Black Sea mussel (Mytilusgalloprovincialis) and the Black Sea oyster (Crassostreagigas) on the 10-20th day of mollusk development. After mechanical cleaning and washing, the mollusks are placed for 2-3 minutes in water with a temperature of about 40 ° C. After opening the shells of the mollusk, biomaterial is collected from bioextractic muscular stomachs and the endodermal sinus with pallial fluid, which are a substrate in the form of nacre and black sea algae, spirulina, kelp, and zoster. Then carry out low-temperature drying - sublimation by dry freezing in containers at a temperature of from -20 to -30 ° C, for a period of 80-120 days. Residual humidity should be no more than 6-8%. At the same time, the enzymatic complex of enzymes, carbonate anhydrase, proteins, complex amino acids (21 acids), mucopolysaccharides, an organic matrix (mother of pearl, which subsequently affects the enamel and dentin resistance) is not destroyed. After thawing, drying and disinfecting from viruses and bacteria, the biomaterial is subjected to fine grinding to the state of dust powder. For ultra-fine grinding, CGS jet mills from the German company NETZSCH (nft.moskau@netzsch.com) are used. The grinding energy is generated by the supply of gas jets through horizontally integrated air nozzles. The classifier eliminates coarser particles, passing only particles according to the configured parameters. With this method of grinding the biological components of the mollusks of the Black Sea oysters, dispersion of 0.8-2.0 μm (0.0008 mm) can be achieved. Such particles in the form of thin needle crystals can actively fill microcracks of tooth enamel.

Zoster - Black Sea algae located in the stomach of a mollusk. The plant contains a large number of easily digestible trace elements: iodine, iron, cobalt, copper, zinc, etc. Of the vitamins, the plant includes: vitamins of group B, carotene and ascorbic acid. Fucondac polysaccharide, a biologically active substance with antitumor activity, was also found in the zoster. Preparations based on zoster, in the first place, are natural sorbents of complex action (hemosorbents and enterosorbents), which contribute to the binding and elimination of harmful substances from the gastrointestinal tract and blood. In addition, they have antibiotic (similar to penicillins), antitumor, immunomodulating, antiulcer, anti-allergenic and radioprotective effects.

Spirulina, a species of blue-green algae of the genus Arthospira, is also found in the mollusk's stomach. It contains eighteen amino acids, of which eight are essential (valine, leucine, isoleucine, threonine, methionine, tryptophan, lysine and phenylalanine), nucleic acids deoxyribonucleic acid (DNA) and ribonucleic acid (RNA), rich in vitamins (A, B1, B2, B6 , B12, B9, E, Biotin - Vitamin B7), macro- and microelements that regulate the metabolism of fats in the body.

Laminaria (sea kale) - the contents of the mollusk's stomach - is rich in proteins, carbohydrates, vitamins, and trace elements.

Mineral waters are complex solutions in which substances are contained in the form of ions, undissociated molecules, gases, colloidal particles. Mineral natural drinking waters are waters extracted from aquifers or aquifers that are protected from anthropogenic impact, preserving the natural chemical composition and related to food products, and with increased mineralization or with an increased content of certain biologically active components, they have a therapeutic and prophylactic effect. The features of mineral water are determined by the geological and structural features, the geological history of the territory, as well as geomorphological, meteorological and hydrological factors. In the area of young folded mountains, carbon dioxide and nitrogen Minvody are often found. Highly mineralized mineral waters and even brine enriched with hydrogen sulfide are characteristic of deep-seated parts of foothill basins. In the deep horizons of the platform depressions, calcium chloride and sodium chloride waters and hydrocarbonate type waters are common; above lies a zone of sulfate waters. The geological structure and hydrogeological conditions of the Saki mineral groundwater deposit made it possible to determine the possibility of obtaining thermal water directly in the resorts of Saki. In sediments represented by sandstones with sand streaks, thermal self-pouring water is obtained in the depth interval up to 906.2 m. In terms of chemical composition, it is sodium bicarbonate chloride. The conditions of the used mineral water of the Saki deposit: (according to the main physical and chemical indicators, according to medical safety criteria for human health, to maximum permissible levels, etc.):

total mineralization of 1.9-2.5 g / dm ³ ; bicarbonate ions 750-900 mg / dm ³ ; sulfate ions 90-140 mg / dm ³ ; chloride ions 450-600 mg / dm ³ ; calcium ions - not more than 15 mg / dm ³ ; magnesium ions - not more than 10 mg / dm ³ ; sodium and potassium ions - 620-750 mg / dm ³ ; strontium - not more than 25.00 mg / dm ³ , chromium - not more than 0.50 mg / dm ³ ; zinc - not more than 5.00 mg / dm ³ ; lead - not more than 0.10 mg / dm ³ ; mercury - not more than 0.02 mg / dm ³ ; selenium - not more than 0.05 mg / dm ³ ; vanadium - not more than 0.40 mg / dm ³ , copper - not more than 1.00 mg / dm ³ ; cadmium - not more than 0.01 mg / dm ³ ; nitrates - not more than 50.00 mg / dm ³ ; nitrites - not more than 2.00 mg / dm ³ ; fluorine - not more than 10.00 mg / dm ³ ; arsenic - not more than 1.50 mg / dm ³ ; phenols - not more than 0.10 mg / dm ³ ; uranium - not more than 1.80 mg / dm ³ ; radium - not more than 5.2 × 10 ^-7 mg / dm ³ ; organic matter per carbon - 5.0-30.0 mg / dm ³ ; the temperature at the wellhead is 38-46 ° C. The total microbial number is not more than 100 KUU / cm ³ ; the number of bacteria of the group of Escherichia coli (coli index) - not more than 3 KUU / dm ³ ; Pseudomonas aeruginosa (Pstudomoni Saeroginosa) - not allowed in 1 dm ³ . The optimal level of microelements of water helps to combine the input components to create an effective paste composition. Small amounts of natural minerals harmoniously interact with all components of the formulation. At the same time, biologically balanced active elements - sodium, potassium, fluorine, calcium, magnesium, productively solve the problem of healthy oral care, maintaining normobiosis.

A trial batch of therapeutic and preventive toothpaste with the optimal composition of ingredients, wt. %: titanium dioxide 5.20; carboxymethyl cellulose (CMC) 2.50; glycerol 9.53; sodium saccharinate 0.19; calcium glycerophosphate 17.82; sodium fluoride 0.09; polyethylene glycol PEG-8 4.76; para-hydroxybenzoic acid methyl ester sodium salt 0.27; para-hydroxybenzoic acid propyl ester sodium salt 0.11; sodium bicarbonate 12.22; sodium lauroyl sarcosinate 1.03; “Biol” preparation - pore solution (wringing) of mud of sulphide sulphide of Lake Saki 8.55; extract of the Black Sea mollusks 7.81; xylitol 5.60; food color pink Ponceau 0.01; water-alcohol extract of cypress-1.16; water-alcohol extract of lavender 0.94; sage essential oil 0.62; chamomile essential oil 0.75; rose essential oil 0.38; drinking water medicinal-canteen bicarbonate-sodium chloride low-mineralized Saki deposit of mineral underground water 20.46.

Clinical trials were carried out on groups of probants aged 7-18 years (84 people) with diseases of caries and hyperesthesia of hard tissues of teeth and 100 people aged 20-55 years with diseases of chronic gingivitis, generalized periodontitis, stomatitis. Stratification of patients into groups was carried out on the basis of a comprehensive dental examination conducted according to generally accepted methods, taking into account the recommendations of the World Health Organization (WHO). The study involved 184 volunteers (101 women and 83 men) who, as a hygiene product for oral care, were provided with trial clinical samples of biominerally active therapeutic and preventive toothpaste. The study was carried out in accordance with the Helsinki Declaration “Ethical Principles for Conducting Scientific Medical Research with Human Participation” as amended according to Order No. 518 of July 21, 2015 of the Federal State Autonomous Educational Institution of Higher Education “Crimean Federal University named after V.I. Vernadsky ”(FGAOU VO“ KFU named after V.I. Vernadsky ”) and in accordance with the provisions of the Convention for the Protection of Human Rights and Dignity of the Human Being in Connection with the Application of Biology and Medicine (Convention on Human Rights and Biomedicine). For two weeks, volunteers brushed their teeth according to standard professional methods, followed by examination and clinical studies (hygiene indices, caries prevalence, periodontal indices). In 97 patients, saliva was collected for biochemical studies, and a fence was taken from the periodontal sulcus for microbiological studies. After 14 and 20 days of brushing, the same clinical studies were repeated. According to the results of clinical trials, the following was noted: in patients with caries, plaque on the teeth decreased, enamel bleaching was visually noted; in patients with grade 1-2 hyperesthesia after applying the paste, pain decreased for 3-4 days, and enamel and dentin hyperesthesia went on day 5; in patients with gingivitis and periodontitis of mild, moderate degree after 7 days of professional cleaning, the absence of bleeding gums, halitosis was noted; in patients with stomatitis on the 3-5th day there was an absence of burning of the oral mucosa, epithelization. As a result of clinical studies, it was found that the treatment and prophylactic multi-active complex in the form of toothpaste is safe for health, does not have local irritating and allergic effects, helps to remove plaque, prevents the formation of tartar, strengthens enamel, and provides effective protection against the spread of carious process in the oral cavity, reduces inflammation in periodontal tissues, mucous membranes, stops hyperesthesia and bleeding gums. A multi-mineral-active therapeutic and prophylactic toothpaste containing minerals in the form of an active organo-mineral base of the “Biol” liquid mud preparation, components of medicinal herbs and essential oils, as well as a substrate of Black Sea mollusks containing nacre, three algae (spirulina, kelp, zoster), based on Saki mineral water, due to the content of a multi-active natural complex reduces tooth sensitivity; inhibits cariogenic bacteria, plaque, tartar formation, protects the gums and mucous membranes from inflammation; strengthens the enamel, whitens and can be recommended for people over the age of 7 years without restrictions with inflammatory diseases of the oral cavity, dental caries, hyperesthesia for daily two-time use.

The method of preparing toothpaste includes the following stages: preparation, disinfection and maintenance of equipment; preparation and disinfection of water; raw material preparation; xylitol preparation; preparation of an aqueous solution of ingredients; preparation of toothpaste in accordance with the technological process of cooking toothpaste. After testing, the finished toothpaste is pumped to the storage tank by a pump, from where it is pumped into the hopper of the tube filling machine. Toothpaste is Packed in a laminate tube measuring 35 × 150 mm and placed in a corrugated box.

Claims (3)

Therapeutic and preventive toothpaste, including the abrasive component - titanium dioxide; a binder is carboxymethyl cellulose (CMC), a humectant is glycerin, preservatives, a sweetener is sodium saccharin; calcium glycerophosphate, sodium fluoride, surfactants; emulsifier, essential oils, drinking water, characterized in that it contains PEG-8 polyethylene glycol as an emulsifier, sodium para-hydroxybenzoic acid methyl ester sodium salt and para-hydroxybenzoic acid propyl ether sodium salt; as essential oils - a mixture of essential oils of chamomile, sage and rose; as surface-active substances - sodium lauroyl sarcosinate; additionally contains water-alcohol extracts of plants - 20-30% water-alcohol extracts of cypress and lavender, sodium bicarbonate (baking soda), Biol preparation - pore solution (squeezing) of sludge sulphide mud from Lake Saki; dried and finely divided substrate in the form of mother of pearl and black sea algae, spirulina, kelp, zoster, obtained by taking biomaterial from muscular stomachs and endodermal sinus with pallic fluid of the Black Sea mussel (Mytilusgalloprovincialis) and Black Sea oysters (Cra); additional sweetener - xylitol, food color pink Ponceau, as drinking water - natural medicinal-table hydrocarbonate-chloride-sodium low-saline water of the Saki mineral underground water deposit, in the following ratio of ingredients, mass%: titanium dioxide 4.70-5.65 carboxymethyl cellulose 1.86-2.80 glycerol 9.20-9.82 sodium saccharin 0.15-0.25 calcium glycerophosphate 16.18-18.67 sodium fluoride 0.07-0.11 polyethylene glycol PEG-8 4.46-5.04 para-hydroxybenzoic acid methyl ester sodium salt 0.23-0.34 para-hydroxybenzoic acid propyl ester sodium salt 0.08-0.14 sodium bicarbonate 11.84-12.63 sodium lauroyl sarcosinate 0.84-1.20 Biol preparation - pore solution (squeezing) of sludge silt mud Saki Lake 8.08-9.05 Black Sea mollusk substrate 7.62-8.04 xylitol 5.32-5.91 food color pink ponceau 0.01-0.01 water-alcohol extract of cypress 1.08-1.25 water-alcohol extract of lavender 0.87-1.02 sage essential oil 0.58-0.67 chamomile essential oil 0.70-0.81 rose essential oil 0.35-0.41 drinking water low-mineralized Saksky hydrocarbonate-chloride chloride mineral groundwater deposits 19.37-22.59