RU2283645C2 - Means for making oral cavity irrigation - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: preparation comprises glycerol, Eftiderm, hawthorn extract, aroma, citric acid, succinic acid, ascorbic acid, lipoic acid, mint oil, sodium fluoride and water. The ingredients are taken in known quantitative proportions.

EFFECT: improved hygienic oral cavity condition; reduced quantity of dental deposit; reduced dental hemorrhages; soft tonic action; improved working capacity; reduced risk of atherosclerosis and age-specific problems.

1 tbl

Description

The present invention relates to medicine, specifically to liquid agents with the inclusion of biologically active substances (BAS) in the form of a spray - a means for irrigation of the oral cavity (CO), which can be recommended as a general strengthening agent, especially for the elderly, CO has a mild tonic action, increases efficiency, improves lipid metabolism, reduces the risk of atherosclerosis and aging processes.

Known means for rinsing the mouth, which have a multidirectional effect (see, for example, RF patent No. 2088210, 1997). Elixirs for rinsing the mouth are also known, such as “Mint”, “Lesnoy”, etc. For example, the composition of the elixir “Lesnoy” includes chlorophyll, carotene, tocopherol, ascorbic acid, flavorings, etc. Unfortunately, the effectiveness of these elixirs is significantly reduced with prolonged use in connection with the adaptation of the microflora of the oral cavity to their effects.

The closest to the patented CO can be considered a mouthwash "Exotic" according to the patent of the Russian Federation No. 2190387, A 61 K 7/16, 2002 - prototype. The specified tool contains biologically active substances - glycerin, eftederm, ascorbic, citric and succinic acids, sodium fluoride, malavit, peppermint oil, eucalyptus oil, chlorhexidine, flavorings and water. The disadvantages of the prototype include the fact that it does not improve lipid metabolism, is not a means of preventing atherosclerosis, and does not slow down the aging process.

The technical task is to increase the efficiency of CO containing a conductor of biologically active substances, the eftederm, which enhances and prolongs the action of the ingredients without increasing their concentration.

The technical result is achieved by the fact that the means for irrigation of the oral cavity, including glycerin, eftederm, flavorings, citric, ascorbic and succinic acids, sodium fluoride, peppermint oil and water, additionally contains liquid hawthorn extract, sodium benzoate and lipoic acid in the following ratio of components, wt.%:

glycerol 5 eftederm 5 hawthorn extract 0.50 flavorings 0.20 sodium benzoate 0.10 lemon acid 0.10 vitamin C 0.10 succinic acid 0.05 lipoic acid 0,025 sodium fluoride 0,07 peppermint oil 0.001 water up to 100

Thus, CO, which we called Gerontovit-E, is an aqueous solution of biologically active substances of organic and plant origin with the addition of flavorings and preservatives.

With most diseases in the body, the content of a number of components necessary for life is violated: trace elements, vitamins, and other biologically active substances. The use of funds (sprays) for irrigation (CO) of the oral cavity allows you to enter most of them through the mucous membranes of the oral cavity, esophagus, etc., which reduces the number of injections and reduces the intake of tablet preparations inside, reduces the number of painful surgical and therapeutic procedures. CO has a sparing effect on the psyche of the patient, increases the effectiveness of the treatment of a number of diseases at a lower cost.

Glycerin has a decongestant effect, softens the mucous membranes, gives a pleasant sweet taste to the means for irrigation of the oral cavity.

Eftiderm conducts biologically active substances through the mucous membranes and skin, significantly accelerates the intake of biologically active substances in the body. It several times enhances and prolongs their action. In addition, eftederm is an anti-inflammatory and decongestant, increases cell viability and immunity, has antioxidant activity, helps increase energy metabolism, and improves lipid metabolism.

Liquid hawthorn extract is an adaptogen that increases the body's defenses, has a mild sedative (sedative) effect, improves the activity of the cardiovascular system (cardiotonic effect: strengthens the strength of heart contractions; reduces the number of heartbeats, eliminates some types of tachyarrhythmia).

Fragrances - give a pleasant smell and taste of CO.

Sodium benzoate is a preservative.

Citric and succinic acids - improve the functioning of the enzymatic systems of the body, increase the speed of the respiratory processes in the tissues, due to which a greater amount of ATP (energy) is formed, fat deposition is reduced, the person's working capacity, his energy increases.

Ascorbic acid - stabilizes cell membranes, reduces the damaging effect of hypoxia (lack of oxygen) on cell structures, promotes the production of ATP, reduces the process of conversion of pre-carcinogens to carcinogens, which prevents the development of cancer.

Sodium fluoride is able to replace hydroxyl ion in enamel apatite, dentin of teeth and bone tissue, helps to reduce tartar deposits, the prevention of inflammatory diseases of the oral cavity, including - caries.

Lipoic acid normalizes the function of liver cells, promotes the deposition of energy in the liver in the form of glycogen, thereby preventing the formation of adipose tissue and the occurrence of nutritional obesity.

Peppermint oil contains menthol, carotene, flavonoids, triterpenoids, betanin, trace elements, has a restorative, soothing, analgesic, antimicrobial, anti-inflammatory, antispasmodic and hemostatic effect.

Thus, CO in its composition does not contain potentially hazardous components.

With an eftederm content of less than 0.5%, its conductive activity and anti-inflammatory effect are negligible. When the eftederm content is more than 10%, gel-like particles remain in the liquid medium, which complicates the use of CO in connection with the clogging of the mechanical (spray) bottle head.

When the content of citric and ascorbic acid is more than 0.15%, the increase in the expected action is unreliable, in addition, a feeling of discomfort associated with a significant increase in salivation can appear.

When the succinic acid content is more than 0.1%, the sedative effect of CO is reduced.

When the content of sodium fluoride is less than 0.007%, there is practically no decrease in the formation of dental plaque, and at a concentration of more than 0.02%, an increase in the therapeutic effect is not significant. In addition, there is a danger of side effects.

The proposed tool also contains flavorings in an amount of 0.05-0.5 wt.%, Depending on its type, as well as a preservative of sodium benzoate in the amount recommended by the Ministry of Health - 0.1%.

The following ingredients are used to make the Gerontovit-E oral irrigation product:

- drinking water according to GOST 2874-82,

- glycerin according to GOST 6824-76 in the form of a liquid,

- eftederm according to FS 42-3372-97 in the form of a gel,

- liquid hawthorn extract according to GF X st. 260,

- natural flavors according to the current ND or having the permission of the SSES of the Ministry of Health of the Russian Federation in the form of a powder or liquid,

- sodium benzoate according to GOST 30059-93 in the form of a powder,

- citric acid according to GF X s. 888 in the form of a powder,

- ascorbic acid according to GF X Art. 6 in the form of a powder,

- succinic acid according to GOST 6341-75 in the form of a powder,

- sodium fluoride according to ND GPX 1.042.076 / 2 Reg. number P-8-242 No. 010692 in the form of powder,

- lipoic acid according to FS 42-1918-94 in the form of a powder,

- peppermint oil according to GF X st. 488 in the form of liquid.

SB "Gerontovit-E" is obtained as follows. First, the right amount of eftederm is mixed with water in a ratio of 1: 4, thoroughly triturated until the jelly-like inclusions of eftederm disappear (Intermediate 1). After that, each dry ingredient that is part of the proposed CO is weighed on an analytical balance, crushed into fine powder, sieved through a No. 26-29 sieve, then thoroughly triturated with intermediate 1 in a ratio of at least 1: 3 and introduced into a boiler with a stirrer. Water and other liquid ingredients are added in the right amount and mixed until all components are completely dissolved. As a result, an oral irrigation agent is obtained in the form of a yellow-brown liquid with a sweetish taste and smell of the flavoring used. If necessary, colorants and flavorings are added to the CO. Packaging and labeling of bottles for CO is carried out in accordance with the requirements of GOST 28303 or ISO 11609.

According to the requirements of the Pharmacological Committee of the Ministry of Health of the Russian Federation, a study was conducted on experimental animals, which showed that Gerontovit-E does not have a toxic, allergenic and local irritant effect. It belongs to the IV class of substances - “low-hazard substances”.

In order to identify the pharmacological activity, specific action and possible complications of the Gerontovit-E oral irrigation product, it was studied in comparison with placebo (CO without active ingredients).

1) Violation of lipid metabolism in rats was modeled by daily administration of 2.5 g of a mixture of lipids into the stomach through an elastic probe for a month. Rats were divided into 3 groups: intact animals; the group receiving the Gerontovit-E SB and the group receiving the placebo. Before the experiment and 30 days after its completion, peripheral blood was examined, biochemical parameters were determined: total lipids, β-lipoproteins, cholesterol, triglycerides. The animals were weighed once a week, constantly monitoring the general condition, behavior, appetite.

2) To mice (intact; the group receiving Gerontovit-E, and the group receiving placebo) before the experiment and 24 hours after its completion, exercise was performed - swimming. They recorded the time during which they swam freely without diving into water.

Research results. It was found that rats treated with Gerontovit-E were more mobile, less likely to approach the feeder and drinker compared to animals that received placebo and intact. In all animals treated with CO, the peripheral blood practically did not differ from that in animals of other groups, however, there was a tendency to an increase in the number of red blood cells and their resistance, and a decrease in the number of reticulocytes and eosinophils was also noted.

In animals treated with placebo on the background of lipid loading, there was a decrease in the number of red blood cells by 7.3%, an increase in the number of reticulocytes - by 7.4%. The change in biochemical parameters is presented in the table.

Table
Biochemical blood parameters of rats after 30 days of the experiment Group No. Applied effect β-lipoproteins Triglycerides mmol / L Cholesterol Mmol / L one. Intact 5.7 ± 0.21 1.8 ± 0.08 3.4 ± 0.13 2. Gerontovit-E 5.8 ± 0.26 1.9 ± 0.06 3.5 ± 0.11 3. Placebo 6.2 ± 0.19 * 2.1 ± 0.09 * 3.8 ± 0.12 * Note. Comparison was made with intact animals.
Reliable values at p <0.05 are marked *.

Changes in blood biochemical parameters were as follows. The rats of the 2nd group practically did not differ from those in intact rats, while in the animals of the 3rd group the content of β-lipoproteins increased by 8.8%, triglycerides - by 16.7%, cholesterol - by 11.8% .

The difference in body weight gain in rats treated with CO and in intact was not significant. Animals of the 3rd group arrived in weight by 6.7 and 13.8% (in terms of time). Swimming time in mice treated with CO increased by 38.2% compared with animals treated with placebo.

Clinical studies of the Gerontovit-E oral irrigation product (spray) were carried out on 30 male and female volunteers aged 45-70 years, suffering from stomatitis against the background of grade 2 obesity and atherosclerosis. All patients complained of usual for their pathology, including decreased memory, performance, increased appetite.

The oral cavity was irrigated with two single doses of the agent used in the group from a bottle with a dosing mechanical head 3 times a day after meals for 30 days. Studies were carried out before the first and after a 30-day intake of Gerontovit-E or placebo (CO without active components).

The following research methods were used: measurement of heart rate, NPV, blood pressure, body temperature; carried out hand dynamometry, proof-reading, reaction rate to external light and sound stimuli (red, yellow and green, ringing), subjective assessment on the SAN map (well-being, activity, mood).

Before and after the study, a general blood test, blood biochemistry were studied: hepatogram, total protein, cholesterol, β-lipoprotein content. To assess the effect of Gerontovit-E and placebo on the oral hygiene, control examinations of the subjects were carried out taking into account the clinical picture and subjective sensations before use 14 and 30 days after the start of use of the studied drugs with evaluation of plaque index (DI), dental index stone (IZK) and bacterioscopy. The following was established:

1) the average blood parameters before the study indicated

- decreased cellular immunity (reduced number of lymphocytes and monocytes);

- coagulemia (increased platelet count and reduced blood coagulation time);

- violation of lipid metabolism with a significant increase in total blood cholesterol and low-density β-lipoproteins (LDL) and triglycerides (TG) in all studied. The amount of high density lipoproteins (HDL) has been reduced. These changes corresponded to lipid metabolism disorders with atherogenic (atherosclerotic) mood.

After taking “Gerontovit-E”, favorable changes in peripheral blood parameters were noted:

- the number of red blood cells increased by 11.3%, lymphocytes - by 35.4%, monocytes - by 39.5%;

- the number of platelets decreased by 17.1%, eosinophils - by 35.9%;

Blood biochemical parameters have changed as follows:

- the number of β-lipoproteins (LDL) in men decreased by 9.3%, in women - by 8%, cholesterol - by 7.5%. In the placebo group, changes in blood parameters were unreliable.

The remaining recorded indicators of all the studied practically did not change.

When evaluating the proof-reading test, an increase in the analytical ability of the central nervous system was registered by 11.5% in men and 13% in women. The carpal force in men increased by 9.4%, and in women by 10.2%, which indicated a slight increase in physical performance. When analyzing the subjective state according to the SAN test, the subjects noted an improvement in well-being. No significant changes in other indicators were noted.

In 80% of those observed using CO, stomatitis-related complaints disappeared. Erosions epithelized, bleeding of gums disappeared, pain “from hot and cold” decreased, bad breath disappeared or sharply decreased. After 30 days of application, COI DI decreased by 48.3%, and IZC by 45.7%; in the placebo group, by 5.1 and 2.9%, respectively.

Bacterioscopic indices significantly decreased in both groups, CO - by 43.9%, placebo - by 4.8%.

Most patients receiving CO noted improvement in well-being, a slight increase in working capacity and memory, and a decrease in appetite after 10-15 days of taking Gerontovit-E (20-30% reduction in the amount of food needed for satiety).

Thus, Gerontovit-E SB has a general strengthening effect, enhances immunological defense, helps normalize metabolism, especially lipid metabolism, and significantly reduces the atherogenic mood of the body, i.e. is a prophylactic for the development of atherosclerosis, which simultaneously leads to a slowdown in the aging of the body.

findings

Means for irrigation of the oral cavity "Gerontovit-E" has:

1) pronounced conduction activity, cytoprotective effect - increases cell viability;

2) a mild anti-inflammatory and tonic effect, increases immunity and performance, accelerates reparative processes, has a beneficial effect on hematopoiesis and metabolic processes, especially lipid metabolism, reduces atherogenic mood and aging of the body;

3) provides improved oral hygiene, reduces the amount of dental deposits, reduces bleeding gums;

4) does not have toxic and allergenic effects, belongs to the IV class of substances - "low-hazard substances";

5) is rapidly excreted from the body, does not accumulate, does not have a local irritant effect.

Means (spray) for irrigation of the oral cavity "Gerontovit-E" can be recommended for use by the population, especially working or living in environmentally unfavorable conditions. It is intended to increase the body's defenses, provides improved oral hygiene, reduces the amount of dental deposits, reduces bleeding gums, is a prophylactic for liver diseases, atherosclerosis, obesity, and improves the central nervous system.

Gerontovit-E oral irrigation agent can be recommended for the prevention of pathology of the mucous membranes and organs of the oral cavity, as a general strengthening, soft tonic and deodorizing agent, especially for the elderly, the spray improves performance, improves lipid metabolism, reduces the risk of development atherosclerosis and aging processes.

The proposed tool for irrigation of the oral cavity meets the criteria of novelty, non-obviousness and industrial applicability, in connection with which it is proposed to legal protection by a patent for an invention.

Literature

1. Actual issues of allergology and immunology. Tashkent. 1978, p. 79-83.

2. Alekseeva O.G., Dueva L.A. Allergy to industrial chemical compounds. M .: Medicine, 1978, 272 p.

3. Alekseeva O.G., Petkevich A.I. To the methodology for determining the allergenic properties of chemicals. // Hygiene and sanitation, 1972, p. 64-67.

4. Gubler E.V., Genkin A.A. The use of non-parametric statistical criteria in biomedical research. M .: Medicine, 1973, 141 p.

5. Zapadnyuk I.P., Zapadnyuk V.I., Zakharia E.A., Zapadnyuk B.V. Laboratory animals. Kiev .: Vishka school, 1983, 384 p.

6. Izmerov N.F., Sanotsky M.V., Sidorov N.K. The toxicity parameters of industrial poisons in a single exposure. M .: Medicine, 1977, 197 p.

7. Guidelines for the experimental (preclinical) study of non-steroidal anti-inflammatory substances. The publication is official. M .: 1983.

8. Guidelines for assessing the allergenic properties of pharmacological agents. M .: Medicine, 1988, 19 p.

9. Guidelines for assessing the immunotoxic properties of pharmacological agents. M .: MSTU, 1992, 39 p.

10. Requirements for the preclinical study of the general toxic effects of new pharmacological substances. M .: 1985, p. 18.

11. Urbakh V.Yu. Statistical analysis in biological and medical research. M .: Medicine, 1975, 290 p.

Claims (1)

An oral irrigation agent including glycerin, eftederm, flavorings, citric, ascorbic and succinic acids, sodium fluoride, peppermint oil and water, characterized in that it contains hawthorn extract, sodium benzoate and lipoic acid in the following ratio, wt.% : Glycerol 5,0 Eftiderm 5,0 Hawthorn extract 0.5 Flavors 0.2 Lemon acid 0.1 Vitamin C 0.1 Sodium benzoate 0.1 succinic acid 0.05 Lipoic acid 0,025 Peppermint oil 0.001 Sodium fluoride 0.007 Water Up to 100