RU2113842C1 - Tooth paste - Google Patents

Abstract

FIELD: medicine, cosmetology. SUBSTANCE: tooth paste contains biologically-active additive - chitosan succinate, glycerine, sodium carboxymethyl cellulose, sodium lauryl sulfate, taste additive - saccharin, food color, sodium monofluorophosphate, sorbitol, sodium benzoate or methyl ether, fruit flavor, water and silicon dioxide. All ingredients are taken in fixed quantitative ratio. EFFECT: antiinflammatory and caries-prophylactic action; improved cleaning and deodorizing properties. 3 tbl

Description

 The invention relates to medicine, in particular to dentistry, and relates to therapeutic and prophylactic drugs used for the care of teeth and oral cavity.

 The effectiveness of toothpastes is determined, as a rule, by a rational combination of therapeutic and prophylactic activity and adequate consumer properties - a cleansing and deodorizing effect.

 The therapeutic and prophylactic effectiveness of toothpastes depends on the presence of biologically active substances in them. So fluorine-containing compounds (pyrophosphates, monofluorophosphates, etc.) determine their carioprophylactic effect, and plant extracts - anti-inflammatory.

 Known toothpaste containing chalk, sodium carbomethyl cellulose, glycerin, sodium lauryl sulfate, alcohol-glycerin extract of Japanese cucumari, saccharin, xidiphone, perfume and water.

 However, this toothpaste, like others made on a chalk basis, has a strong abrasive effect, which can cause injury to the inflamed mucosa. In addition, fluorine is destroyed in the chalk environment, and therefore the carioprophylactic activity of chalk pastes with fluorine is reduced. The chalk base is also technologically inconvenient for the introduction of biologically active components.

 Known gel toothpaste containing aerosil, glycerin, sodium carboxymethyl cellulose, lacris, sodium lauryl sulfate, citric acid, saccharin, alcohol-glycerin horse chestnut extract, sanguirythrin, perfume and water.

 However, this toothpaste has a weak therapeutic activity.

The essence of the invention lies in the fact that for the first time a gel toothpaste is proposed containing, as biologically active components, a combination of chitosan and monofluorophosphate, and glycerol, saccharin, sorbitol, sodium CMC, lauryl sulfate, sodium benzoate, silicon dioxide, flavoring, food coloring as a base and water in the following ratios of components, in wt.%:
Glycerin - 5.0-10.0
Saccharin - 0.04-0.1
Sorbitol - 50.0-60.0
Sodium carboxymethyl cellulose - 0.7-1.0
Monofluorophosphate, sodium - 0.5-0.8
Chitosan Succinate - 0.2-0.5
Sodium Lauryl Sulfate 30% - 4.0-5.0
Sodium benzoate - methyl ether - 0.05-0.5
Silica - 5.0-9.0
Fragrance fruit - 0.2-1.0
Food Coloring - 0.001-0.003
Water - up to 100.0
Significant features of the proposal should be considered the qualitative and quantitative composition of the paste, as well as the introduction of the composition of the composition of the biologically active additives - chitosan in combination with sodium monofluorophosphate.

The following is a brief description of the raw materials that make up the paste:
Glycerin and sorbitol give the product plasticity and frost resistance, create the desired consistency.

 Sodium carboxymethyl cellulose and silicon dioxide are gelling components.

 Sodium Monofluorophosphate - Anticaries Supplement.

 Chitosan succinate is a natural polysaccharide obtained by chemical treatment of crab shells. It contains highly reactive amino groups. In the literature, there are indications of the use of chitosan as an antitumor, wound healing, immunostimulating agent. It is used in cosmetics as a biologically active additive in skin and hair care products. In dentistry, the use of an adhesive composition based on chitosan for fixing removable dentures has been proposed.

 In the composition of toothpastes has not been previously used.

 Sodium lauryl sulfate is a foaming component.

 A preservative is added to preserve, extend the shelf life and prevent microbial infection.

 Fragrance is added to give a pleasant smell to the paste, saccharin - to improve the taste.

 The technological process for producing toothpaste involves several stages.

 1. Preparation of raw materials.

 2. Mixing the components and obtaining a gel.

 3. Perfumes and aging.

 4. Packing.

 Prescription amounts of all components are weighed. Sorbitol, a preservative, glycerin with carboxymethyl cellulose, water, sodium monofluorophosphate, chitosan, saccharin and a dye solution are loaded into the reactor with stirring. All components are thoroughly mixed. Then, silica, sodium lauryl sulfate solution and perfume are charged. All components are thoroughly mixed. A gel-like toothpaste is a homogeneous gel-like mass with an accepted fruity aroma and taste.

 To disclose the invention below are the results of experimental clinical studies of the claimed toothpaste.

 Tests of toothpaste were made in accordance with the requirements of the "Methodological guidelines of the Ministry of Health of the USSR for the experimental (pharmacological) and clinical testing of preventive therapeutic toothpastes", 1983 and the "Temporary list of indicators subject to mandatory monitoring during the hygienic certification of oral hygiene products and perfumes - cosmetics ", approved by the State Committee on epidemiological surveillance of the Russian Federation on December 21, 1993

1. Clinical trials of toothpaste
1.1. Assessment of organoleptic properties.

 1.2. The study of the cleansing action.

 1.3. The study of anti-inflammatory effect.

 1.4. The study of possible allergenic and local irritating effects.

 1. Clinical trials of toothpaste material and methodology.

 The study of the paste was carried out among people aged 10.4 years of both sexes in the amount of 80 people.

 Selected individuals had the same level of hygiene skills, provided with the same toothbrushes. Teeth cleanliness with the help of the studied paste was carried out twice a day (morning and evening) for three minutes using the combined technique independently.

 Before the start of the study, all probants underwent professional oral hygiene: soft and hard dental deposits were removed, and fillings were polished. During and at the end of the test, probants gave feedback on the properties of toothpaste based on subjective sensations.

 The studies were carried out by a double blind method. We studied sample No. 1 (without chitosan) and sample No. 2 (with chitosan). However, the composition of the pastes was not known to patients and doctors.

1.1. Assessment of organoleptic properties
When studying the organoleptic properties of the paste, the evaluation of the appearance, color, taste and smell by the probants was taken into account.

 The tested paste, according to the testants, has a satisfactory taste, aroma and satisfactorily foams.

 1.2. Studying the cleansing effect of the paste.

 1.2.1. The study of a single cleansing action.

 A common criterion for evaluating the cleaning properties of toothpastes is the presence of soft plaque after brushing. To quantify it, use plaque indices, the so-called hygiene indices, which are determined before and after using toothpaste.

 To assess the cleaning effect of the studied paste, we used the Green-Vermillion hygiene index change, which was determined before and after toothbrushing.

To detect plaque, the vestibular surfaces of 16, 11, 26, and 31 teeth and lingual surfaces of 36 and 46 teeth were stained with potassium iodide-iodide solution. Quantitative assessment was carried out according to a four-point system;
staining the entire surface of the tooth crown - 3;
staining 2/3 of the surface of the tooth crown - 2;
staining 1/3 of the surface of the tooth crown - 1;
lack of staining of the tooth surface - 0.

Hygiene index was calculated by the formula:
Cor. - to / 6, where Cor. - quantitative hygiene index; k is the sum of the index values for all teeth; 6 - the number of teeth.

 The determination of a single cleaning action of the paste was carried out after a single brushing of the teeth for 3 minutes. The hygiene index was determined before and after cleaning.

 Based on the results obtained, a one-time reduction of plaque was calculated (Table 1), which is equal to arr. N 1 - 33%, for arr. N 2 - 45.5% and for the control. - 21.1%.

 1.2.2. Examination of a cleanser for 2 months.

 A study of the cleansing effect of the paste for 2 months was also carried out using the Green-Vermillion hygiene index. The probants in the morning and evening brushed their teeth with toothpaste on their own. The index was determined 1 time per week. The effectiveness of the cleaning action of toothpaste for a month of use was determined by comparing the indices of the first and last inspection (table. 2). The cleaning effect for the month was: arr. N 1 - 29.1%, arr. N 2 - 58% and control. - 10.2%.

1.3. The study of anti-inflammatory properties of toothpastes
The anti-inflammatory properties of the test paste were evaluated by determining the PMA index. Inspection of the gums was carried out sequentially with the vestibular surface. The studies were carried out with controlled brushing of the teeth for a month.

,
в которой показатели определяли по трехбальной шкале
воспаление десневого сосочка - 1
воспаление края десны - 2
воспаление альвеолярного отростка челюсти - 3
Индекс РМА получали путем сложения оценки состояния пародонта у каждого зуба, при этом учитывали, что среднее число зубов в возрасте старше 15 лет - 30, а младше 15 лет - 28.The PMA index was calculated by the formula

,
in which indicators were determined on a three-point scale
gingival papilla inflammation - 1
inflammation of the gingival margin - 2
inflammation of the alveolar bone of the jaw - 3
The RMA index was obtained by adding up the periodontal status of each tooth, taking into account that the average number of teeth older than 15 years old was 30, and under 15 years old - 28.

 For a clearer identification of the boundaries of the inflammatory reaction of the gingival mucosa, along with a visual examination, a Schiller-Pisarev test was used (gum staining with a solution of iodine in potassium iodide). Evaluation of the anti-inflammatory effect was carried out on the basis of the dynamics of the PMA index, which was determined during follow-up examinations once a week for a month.

 After using the test paste for a month, the periodontal condition improved markedly. The anti-inflammatory effect of the paste (table. 3), defined as a reduction in the PMA index, amounted to arr. N 1 - 38%, for arr. N 2 - 46%, for control - 30%.

1.4. Study of possible allergenic and local irritant effects
When examining the oral cavity examined the lips, tongue, palate, the mucous membrane of the gums, the inner surface of the cheeks, and the mouth. During the test period, no irritating and allergenic effects of the tested paste were revealed.

 Thus, the use of toothpaste samples N 1 and N 2 did not reveal local irritant and allergic effects. The paste complies with the safety requirements for this type of oral hygiene products.

 This study revealed that the toothpaste of sample No. 2 has better cleaning and anti-inflammatory properties compared to the control paste and sample No. 1, as well as the anti-caries effect, which is expressed in the remineralizing ability of the paste due to the content of 0.8% monofluorophosphate and 0.2% chitosan.

 Toothpaste can be recommended for use as a good cleansing, anti-inflammatory and anti-caries agent.

 Example 1. After weighing the recipe amounts of all components, 50.0 sorbitol is loaded into the reactor with stirring; 0.05 methyl ester; 5.0 glycerol; 0.7 sodium carboxymethyl cellulose; water 0.5 sodium monofluorophosphate; 0.2 chitosan; 0.04 saccharin; 0.001 dye solution.

 All components are thoroughly mixed. Then 5.0 silica, 4.0 sodium lauryl sulfate and 0.2 perfumes are charged. All components are thoroughly mixed. The resulting toothpaste is a homogeneous gel-like mass with a pleasant fruity aroma and taste.

 It has anti-inflammatory, anti-carious, cleansing, deodorizing properties.

 Allergic or other complications during use have not been identified.

 Example 2. After weighing the recipe amounts of all components, 60.0 sorbitol are loaded into the reactor with stirring; 0.5 sodium benzoate; 10.0 glycerol; 1.0 sodium carboxymethyl cellulose; water 0.8 sodium monofluorophosphate; 0.5 chitosan; 0.1 saccharin; 0.003 dye solution. All components are thoroughly mixed. Then, 9.0 silicon dioxide, 5.0 sodium lauryl sulfate and 1.0 perfumes are loaded into the resulting mass. All components are thoroughly mixed.

 The resulting toothpaste is a homogeneous gel-like mass with a pleasant fruity aroma and taste.

 It has anti-inflammatory, anti-carious, cleansing, deodorizing properties.

 Allergic or other complications during use have not been identified.

 Thus, the claimed toothpaste has a high carioprophylactic and anti-inflammatory activity. It cleans teeth well, removes plaque. It has a deodorizing effect.

Claims (1)

Toothpaste containing a biologically active additive, as well as glycerin, sodium carboxymethyl cellulose, sodium lauryl sulfate, a flavoring additive - saccharin, food coloring and water, characterized in that it contains chitosan succinate in combination with sodium monofluorophosphate and additionally sorbitol, sodium benzoate or methyl ether, fruit fragrance and silicon dioxide in the following ratios of components, wt.%:
Glycerin - 5.0 - 10.0
Saccharin - 0.04 - 0.1
Sorbitol - 50.0 - 60.0
Sodium carboxymethyl cellulose - 0.7 - 1.0
Chitosan Succinate - 0.2 - 0.5
Sodium Monofluorophosphate - 0.5 - 0.8
Sodium Lauryl Sulfate 30% - 4.0 - 5.0
Sodium benzoate or methyl ether - 0.05 - 0.5
Silica - 5.0 - 9.0
Fragrance fruit - 0.2 - 1.0
Food Coloring - 0.001 - 0.003
Water - Up to 100g

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