UA119715U - APISAN GEL FOR LOCAL PREVENTION AND TREATMENT OF TRAUMATIC MUSCULAR INJURY - Google Patents

Abstract

Gel for local prevention and treatment of traumatic lesions of the oral mucosa contains: propolis, burdock wax, lysozyme, buffer system consisting of sodium bicarbonate and calcium carbonate, xylitol, sodium carboxymethylcellulose, glycerin, menthol, distol. Additionally contains sea buckthorn and rose hip oils as active components of plant origin, retinol acetate (vitamin A), tocopherol acetate (vitamin E), in the following ratio, wt. %: propolis 2.50-3.00 wax 4.50-5.00 sea buckthorn oil 4.50-5.00 rose hip oil 3.00-3.50 retinol acetate (vitamin A) 3.44% 0.50- 1.00 tocopherol acetate (vitamin E) 5.00% 0.30-0.50 lysozyme 0.25-0.30 xylitol 1.00-1.25 sodium bicarbonate 0.50-1.00 calcium carbonate 0.50 -1.00 sodium carboxymethylcellulose 1.50-1.70 glycerin 20.00-22.00 menthol (flavoring) 0.02-0.03 distilled water remaining.

Description

The useful model belongs to medicine, namely to the field of drugs and biologically active substances based on propolis, and can be used in dentistry for the prevention and treatment of traumatic lesions of the oral mucosa.

The presence of erosive-ulcerative lesions of the mucous membrane of the oral cavity (SOPR) of different localization and intensity of development, the active influence of the microbial factor, the rapid spread of the pathological process to adjacent tissues, the probability of malignization requires rational local therapy. Local therapy involves the effect on the focus of the affected ENT by eliminating irritating factors, analgesia, cleaning with an effect on the microflora, removing inflammatory complications and improving the hygienic condition of the oral cavity.

It is known to use oil solutions consisting of vitamins A, E, carotene, rosehip oil in the form of applications on affected tissues for the normalization of exchange and reparative processes in the treatment of SOPR HP lesions.

However, the wound-healing effect of the substances used is not high enough due to the lack of antibacterial action, which significantly prolongs the treatment period and can lead to relapses of the disease.

A well-known composition for the treatment of traumatic lesions of the SOPR in the form of sea buckthorn oil ointment and 0.5 95 prednisone ointment |2|.

However, this substance acts for a rather limited time (5-7 minutes), as it is quickly washed away by saliva and removed from the lesion.

In recent times, oral cavity care compositions containing propolis (5-7 wt. 90) and one or more typically surface-active compounds, which are cationic antibacterial substances, are used in dentistry for the treatment of traumatic lesions of the oral cavity. These compositions are used in the form of solid therapeutic films (ZI.

But these films do not have a sufficiently high therapeutic effect due to the instability of the use of a cationic substance with an anionic carrier, which reduces their bioavailability, the absence of a field of action on the affected area, in addition, the indicated means cannot be used in xerostomia, due to the fact that oral fluid is a necessary condition for the dissolution of films.

The closest analog to the proposed useful model is "Apior" gel for local

For the prevention and treatment of complications of the affected tissues of the oral cavity caused by radiation therapy, containing: propolis, wax from zabrus, amaranth oil, mint oil, lysozyme, xylitol, sodium bicarbonate, calcium carbonate, sodium carboxymethyl cellulose, glycerin, as a flavoring menthol, distilled water This gel is applied to the affected areas of the mucous membrane of the oral cavity in the form of applications for 10-12 minutes 2-3 times a day, daily until clinical recovery |4|.

The disadvantage of this tool is the absence of the necessary active components in the composition, which would affect the trophic system, enhancing metabolic processes.

The basis of the useful model is the task of developing the "Apisan" gel for the local prevention and treatment of traumatic lesions of the SOPR, which, subject to the inclusion of sea buckthorn and rosehip oils, retinol acetate (vitamin A) and tocopherol acetate, into the composition of the existing "Apior" gel, which is closest in essence (vit. E) with pronounced keratoplastic properties, which will allow for acceleration of healing, pain relief, protection of the wound surface of the mucous membrane and will increase the anti-inflammatory, antioxidant, reparative and immunostimulating effect, which will allow to expand its availability and use.

The task is solved by the fact that the "Apisan" gel for the local prevention and treatment of traumatic lesions of SOPR, containing: propolis, wax from zabrus, lysozyme, xylitol, sodium bicarbonate and calcium carbonate, sodium carboxymethyl cellulose, glycerin, menthol, distilled water and, according to useful model, additionally contains sea buckthorn oil and rosehip oil, which are biological components of vegetable origin of vitamin A (retinol acetate) and vitamin E (tocopherol acetate), with the following ratio of components, wt. Fo: propolis 2.50-3.00 wax 4.50-5.00 sea buckthorn oil 4.50-5.00 rosehip oil 3.00-3.50 retinol acetate (vitamin A) 3.44 to 0.50- 1.00 tocopherol acetate (vitamin E) 5.00 95 0.30-0.50 lysozyme 0.25-0.30 xylitol 1.00-1.25 sodium bicarbonate 0.50-1.00 calcium carbonate 0.50 -1.00 sodium carboxymethyl cellulose 1.50-1.70 glycerin 20.00-22.00 menthol (flavor) 0.02-0.03 distilled water the rest.

The proposed doses of medicinal components are determined experimentally.

Propolis, the main components of which are vegetable resins, essential oils, wax, as well as numerous mineral elements (copper, iron, zinc, etc.), has a wide therapeutic spectrum.

It affects the normalization of processes in the human body with the simultaneous manifestation of antibiotic, anti-inflammatory, anesthetic, antimicrobial, antitumor, antioxidant, angioprotective effects. Propolis affects the regeneration of tissues, promotes the healing of wound surfaces. When determining the dose of propolis in the composition of the gel, the main goal was to relieve the pain syndrome and achieve anti-inflammatory action. This task is usually achieved with a propolis content of 1.0-3.0 wt. 95. Propolis exhibits antimicrobial and antifungal effects, negatively affecting protozoa in the oral cavity. The propolis content is less than 1.0 wt. 95 does not reduce painful sensations in inflammatory processes of the mucous membrane, does not provide antifungal and anti-inflammatory effects, and more than 3.0 wt. 95 - increases the viscosity of the mixture, which complicates the technological process of making the gel.

Beeswax wax has high immunostimulating and bactericidal properties. Physico-chemical properties of wax, the advantage of its adsorption qualities over desorption qualities, its enveloping effect contribute to the pain-relieving effect, tissue scarring.

Sea buckthorn oil provides a keratoplastic effect due to the content of the necessary macro- and microelements, including vitamins E, C, VI, B2, Vb, E, P, folic acid, flavonoids, carotenoids, etc., due to the presence of fat-soluble bioantioxidants, it reduces the intensity of free radical processes, protects against damaged cell membranes, stimulates reparative processes and accelerates wound healing, has a certain antibacterial, anti-inflammatory, immunostimulating effect.

Rosehip oil is considered a powerful regenerative agent, thanks to the biologically active substances and vitamins included in its composition, it stimulates the recovery and trophic of tissues, reduces the permeability of blood vessels, has anti-inflammatory and immunostimulating effects, which are due to the presence of polyunsaturated fatty acids and flavonoids.

Retinol acetate (vitamin A) plays an important role in the synthesis of proteins, lipids, mucopolysaccharides, necessary metabolic processes, ensures the structural integrity of tissues, modulates processes

From the differentiation of epithelial cells, participates in the processes of keratinization, regeneration of the mucous membrane, activates the synthesis of factors of specific and non-specific protection of the body, increasing resistance to adverse factors.

Tocopherol acetate (vitamin E) is a natural antioxidant, protects the body's endogenous substances from oxidation, participates in protein biosynthesis, tissue proliferation, tissue respiration and other processes of cellular metabolism, providing acceleration of healing, protection of the wound surface.

Lysozyme is an enzyme of the hydrolysis class in the gel, which strengthens the non-specific antibacterial barrier at the points of contact of the affected areas of the mucous membrane with the external environment. Lysozyme destroys the bacterial cell membrane, resulting in its dissolution (lysis).

Xylitol helps to restore the acid-alkaline balance in the oral cavity, exhibits antibacterial and antifungal properties, stimulates salivation, strengthens the protective forces of saliva, which is especially important in case of dryness, decreased functional activity of the salivary glands.

Sodium bicarbonate and calcium carbonate are components of the buffer capacity for adjusting the pH from 7.5 to 9, which helps to restore a neutral pH in the affected environment of the oral cavity.

The low alkaline pH level allows to ensure the stability of substances of natural origin and maintain the pH in the oral cavity at a physiological level.

Sodium carboxymethyl cellulose (NCMC) is included in the gel as a form-forming component. In order to give the proposed gel a jelly-like consistency, the content of NKMC in the gel is 1.5-1.7 wt. 95, while the content is less than 1.5 wt. 95 does not give sufficient stability of the gel, and more than 1.7 wt. 95 leads to thickening of the gel, which is poorly filtered and stirred for a long time in the reactor.

Glycerin is present in the composition of the gel as a moisture-retaining component. In order to give the gel elasticity and prevent it from drying out, the content of glycerin in the gel is 20 wt. 95, content less than

18.0 wt. 95 does not ensure the dissolution of propolis, and more than 22.0 increases the viscosity of the gel, which worsens its mixing.

Menthol is used as a flavoring in the amount of 0.02-0.03 wt. 9".

When applying the gel, the entire surface of the affected area of the oral cavity is covered, while the release of active substances from the gel composition occurs due to the presence of sodium carboxymethyl cellulose in its composition. Such a prolonged effect of the product strengthens its therapeutic effect on pathological processes, which contributes to their rapid recovery.

The gel of the stated composition is prepared in three stages.

At the first stage, an aqueous solution of blanose (sodium carboxymethyl cellulose) is prepared and left to swell. After 30-40 minutes, the solution, heated to 40-45 "C, is homogenized using a stirring device for 15 minutes until a homogeneous substance is reached.

At the second stage, prepare a glycerin solution of propolis, wax at a temperature of 700-807 for 30 minutes, to which sea buckthorn and rosehip oils are added after cooling the solution to 40-45 "С, filter.

At the third stage, after filtering the NKMC solution, heated to 40-45 "C with constant stirring, successively, with an interval of 10 minutes, the filtered glycerin solution prepared from propolis, wax and oils from the second stage is also added. Then an aqueous solution of lysozyme is added, sodium carbonate and calcium carbonate, xylitol, retinol acetate, tocopherol acetate, flavoring and distilled water according to the proposed ratio of components.

The proposed remedy was applied to 38 patients with various etiopathogenetic factors of traumatic lesions of the ENT. All patients had pronounced keratoplastic, anti-inflammatory, analgesic effects from the use of the proposed gel.

In this way, the patients observed a rapid elimination of inflammation, elimination of the painful syndrome, a reduction in the period of epithelization by two times, and healing of the wound surfaces of the SOPR.

In comparison with the closest analogue, the proposed "Apisan" gel for the local prevention and treatment of traumatic lesions of the mucous membrane of the oral cavity at the expense of the declared set of symptoms allows to strengthen the prolonged anti-inflammatory, analgesic, keratoplastic, antioxidant, immunostimulating effects in a targeted manner.

From sources of information: 1. Pat. 2383337 Russian Federation IPC Ab1K31/04 (2006.01), Ab1R1/02 (2006.01).

Means for local treatment of periodontal and oral mucosa diseases / Kollerova M.S., Larionov L.P., Grigoryev S.S. Publ. 2010.03.10. Bul. 3. 2. Pat. 2508120 С1 Российской Федерации IPC AbЕ1К36/72, Аб1КЗ1/573. Adhesive ointment for the treatment of damaged oral mucosa / Syrak S.V., Chebotarev V.V.

Kophlova I.A. Publ. 2014.02.27. Bul. 6.

Z. Pat. 20220964 USA, IPC(2006) Ab1c1/00. Oral care compositions containing propolis / Fetisova N., Blanvale K., Lomber P.; applicant and patentee

Colgate Palm Oil Company. MO 2008129657/15; statement 2006.12.21: publ. 2010.01.27. Bul. Mo. 1. 4. Pat. 102204 Ukraine, IPC(2006) AbIM5/10, Ab1KZ31/19, Ab1K35/56. "Apior" gel for local prevention and treatment of complications of affected tissues of the oral cavity caused by radiation therapy / Kravchenko L.S., Solodenko H.M.; applicant and patent owner Odesa. national honey. Univ. of Mo. ts201502575; published 2015.10.26. Bul. Mo 20.

Claims (1)

USEFUL MODEL FORMULA Gel for the local prevention and treatment of traumatic lesions of the oral mucosa, containing: propolis, wax from zaburus, lysozyme, a buffer system consisting of sodium bicarbonate and calcium carbonate, xylitol, sodium carboxymethylcellulose, glycerin, menthol, distilled water, which is distinguished by the fact that it additionally contains sea buckthorn and rosehip oils as active components of plant origin, retinol acetate (vitamin A), tocopherol acetate (vitamin E), with the following ratio of components, weight. 9: propolis 2.50-3.00 wax 4.50-5.00 sea buckthorn oil 4.50-5.00 rosehip oil 3.00-3.50 retinol acetate (vitamin A) 3.44 95 0.50- 1.00 tocopherol acetate (vitamin E) 5.00 95 0.30-0.50 lysozyme 0.25-0.30 xylitol 1.00-1.25 sodium bicarbonate 0.50-1.00 calcium carbonate 0.50-1.00 sodium carboxymethyl cellulose 1.50- 1.70 . 20.00 - glycerin cer 22.00 menthol (flavor) 0.02-0.03 distilled water the rest.