RU2438654C1 - Hydrogel composition for treating burns - Google Patents

Abstract

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to medicine, particularly to dermatology, and represents a hydrogel composition for treating burns, containing immobilised active and auxiliary ingredients and a gelling ingredients, differing by the fact that as an active component it contains a drug substance of 2-allyloxyethanol in amount 0.1 to 10.0 (wt %), as auxiliary ingredients it contains a drug substance of lidocaine in amount 0.1 to 5.0 (wt %) or drug substances of lidocaine in amount 0.1 to 5.0 (wt %) or dezoxynate in amount 0.1 to 5.0 (wt %), as a gelling ingredient it contains hydroxypropyl cellulose in amount 0.1 to 5.0 (wt %).

EFFECT: invention provides enhancement of first-aid treatment of local burns of various aetiologies, including radiation ones, at all the stages of the first-aid treatment, also application in emergency medicine as a all-purpose drug in treating granulating wounds of various aetiologies: continuous ones; for inflammation relief in skin diseases, and also for treatment of insect bites.

5 cl, 2 ex

Description

The invention relates to medicine, in particular to pharmacology, namely, to the means used to treat burns in emergency medicine, can be used at all stages of medical evacuation in the treatment of patients with radiation, thermal and sunburns of the I-IIIA degree, as well as granulating wounds of various etiologies for treating insect bite sites.

A known composition for treating burns is the Likozol aerosol, developed on the basis of the well-known domestic drug Lyoxazole, produced in the form of an aerosol, which has many years of use for the prevention and treatment of acute local radiation injuries of the skin of I and II severity (patent RU 2058777 " Aerosol preparation for the treatment of radiation burns ”, IPC A61K 9/12, 1996). This technical solution is the closest to the claimed invention, therefore, it is taken as a prototype.

The disadvantage of the prototype is the limited use for the treatment of deep burns due to the presence in its composition of alcohol, leading to a sharp burning sensation and soreness.

Another disadvantage of the known composition is the use of the drug in the form of a foam aerosol composition of medicinal and biological active compounds, the active principle of which is water-salt 2-allyloxyethanol (2-AOE), lidocaine (trimecaine), collagen and vitamin E.

This form of release of this drug - aerosol packaging with freon as a carrier gas at the moment cannot be used in connection with the signing by the Government of Russia of the Montreal Protocol on the rejection of the use of ozone-depleting refrigerants (freons, chladones). In connection with the foregoing, this form of the drug is not currently available.

The main therapeutic effect of this complex drug is due to the action of 2-AOE, which has the ability to prevent spasms (sharp narrowing) of the arteries of the skin, improve blood circulation to the skin and accelerate reparative (recovery) processes in the epithelium.

Currently, new dosage forms - hydrogels and hydrogel wound dressings are relevant for local and local treatment of wounds and burns.

Known hydrogels of domestic production "APPOLO" [RU No. 29/010050501 / 1564-01, 2001-07-31], hydrogel wound dressings "APPOLO-PAK-AM", "APPOLO-PAK-AI" and others, created on the basis of a copolymer of acrylamide and acrylic acid with the inclusion of antiseptics miramistin or iodovidone and a local anesthetic anilokain and having a sorption capacity of 2-3 g / g Such coatings have antimicrobial, anti-inflammatory and analgesic effects, but do not contain antioxidant agents, which reduces their effectiveness in purulent-destructive processes. The disadvantage of this drug is the lack of influence on the treatment of radiation burns, which significantly narrows the therapeutic spectrum of the use of this drug in emergency medicine.

Domestic hydrogel materials based on sodium alginate with derinate (sodium deoxyribonucleate) “Coletex-gel-DNA”, as well as with Derinat and lidocaine “Coletex-gel-DNA-L” [RU No. ФСР 2007/00894 from 10/15/2007, are also known .], possessing a wide enough spectrum of action and used for the prevention and treatment of radiation reactions and damage to the mucous membranes (oral cavity and oropharynx, bladder, rectum, vagina, etc.) during and / or after radiation therapy, and also for the treatment of long non-healing wounds and trophies iCal ulcers, burns household.

The disadvantage of these funds is a weak wound healing activity, the lack of indications of the antiseptic effect of these hydrogels, their lack of versatility and effectiveness in emergency medicine.

Currently, pharmacological preparations are not known in the form of ready-made dosage forms for local treatment in the form of hydrogel anti-burn agents containing the active substance, 2-allyloxyethanol.

The technical result when using the invention is to expand the operational capabilities for first aid for local burns of various etiologies, including radiation, at all stages of medical care, as well as the use in emergency medicine as a universal tool in the treatment of granulating wounds of various etiologies: sluggish; to relieve inflammation in skin diseases, as well as to treat insect bite sites. The technical result is achieved in that the hydrogel composition for treating burns contains immobilized active and auxiliary ingredients and a gel-forming component. As an active ingredient contains a medicinal substance of 2-allyloxyethanol (FSP 42-0043-3102-06) in an amount of from 0.1 to 10.0 wt.%. As auxiliary ingredients it contains medicinal substances of lidocaine (ND 42-14192-06) in an amount of from 0.1 to 5.0 wt.% And deoxinate (FSP 42-8765-07) in an amount of from 0.1 to 5.0 wt. .%. As a gelling component contains hydroxypropyl cellulose (KLUCEL ^® ) in an amount of from 0.1 to 5.0 wt.%.

The active ingredient consists of 2-allyloxyethanol in a concentration of (4.0 ± 0.5)%. The auxiliary ingredient consists of lidocaine in a concentration of (2.5 ± 0.5)%. The auxiliary ingredient consists of deoxinate at a concentration of (0.3 ± 0.1)%. The hydrogel composition additionally contains at least one of the substrates: fabric or non-woven material, mesh fabric in their mass ratio to the gel-forming component as 1: 3 ... 1: 8.

A practical embodiment of the invention provides three versions of a hydrogel anti-burn agent:

Version 1. Hydrogel dressing, anti-burn, sterile "LIOXAZIN-SP" based on hydroxypropyl cellulose with immobilized 2-allyloxyethanol and lidocaine on a napkin in an individual package.

Version 2. Hydrogel dressing, anti-burn, sterile "LIOXAZIN-Gel" based on hydroxypropyl cellulose with immobilized 2-allyloxyethanol and lidocaine in an individual package.

Version 3. Hydrogel dressing, anti-burn, sterile "LIOXAZINE D-Gel" based on hydroxypropyl cellulose with immobilized 2-allyloxyethanol, deoxyribonucleate (deoxinate) and lidocaine in individual packaging.

These hydrogel anti-burn agents have a local anesthetic, anti-inflammatory and regenerative stimulating effect on burns of various etiologies, including radiation.

The proposed anti-burn agents are highly effective. They have a pronounced wound healing effect in the 1st, 2nd and 3rd phases of the wound process and affect reparative processes in the epithelium, improving microcirculation of the dermal vessels by preventing early spasm of the arteries of the deep vascular plexus of the skin; participate in the weakening of pathological afferentation from affected areas that occurs when exposed to ionizing radiation on the skin, burns of any etiology; activate the growth of granulations and epithelium. Antimicrobial activity is associated with stunted microflora under St.epid specimens. and Ps.aeroginosa. The therapeutic effect of the drugs is provided by the combined effect of the incoming components, acting on several pathological links, namely: pain, drying or swelling of the wound and infection of the burn surface.

Anti-burn hydrogels, which are a composition of medicinal compounds consisting of 2-AOE and lidocaine (sodium deoxyribonucleate (deoxinate) added by LIOXAZIN D-Gel) provide a complex multifactorial effect on the course of a complicated wound process.

Lidocaine in combination with a cooling effect provides rapid anesthesia of damaged tissues.

2-AOE prevents the disorder of the microvasculature, promotes the activation of proliferation in tissues that have remained viable, improves blood circulation in the affected area and accelerates the reparative processes in the epithelium.

Sodium deoxyribonucleate (deoxynate) - is a narrow fraction of the sodium salt of deoxyribonucleic acid. Sodium deoxyribonucleate has immunomodulating, anti-inflammatory, reparative, regenerating actions. It activates antiviral, antifungal and antimicrobial immunity at the cellular and humoral levels. Regulates hematopoiesis, normalizing the number of leukocytes, granulocytes, phagocytes, lymphocytes and platelets. Corrects the state of tissues and organs with dystrophy of vascular origin, exhibits weak anticoagulant properties. Accelerates the rejection of necrotic masses. Stimulates the reparative processes of damaged areas of the skin and mucous membranes. Facilitates engraftment of autografts during skin grafts.

At the same time, the claimed product has no contraindications, it is harmless, does not cause allergic reactions, has no age restrictions, does not require additional use of other drugs, including antibacterial drugs, etc.

A comparison of the claimed technical solution with the state of the art known from the scientific, technical and patent documentation as of the priority date in the main and related sections did not reveal a tool that has features identical to all the features contained in the claims proposed by the applicant, including the purpose of the application. That is, the set of essential features of the claimed solution was not previously known and is not identical with any known technical solutions, therefore, it meets the patentability condition of “novelty”.

This technical solution is industrially applicable, since its purpose is indicated in the description of the application and the title of the invention, it can be carried out industrially and used to treat burns, efficiently, feasibly and reproducibly, and the distinguishing features of the device allow to obtain the desired technical result, i.e. are significant.

The invention, as described in each of the claims, can be carried out using the tools and methods described in patent RU 2058777, which became public until the priority date of the invention. In addition, the feasibility of the invention is confirmed by the following examples.

Therefore, the claimed technical solution meets the condition of patentability "industrial applicability".

The analysis of known technical solutions in the art showed that the proposed technical solution does not follow explicitly from the prior art for the specialist, since solutions having features matching the distinguishing features of the invention have not been identified and the influence of the distinctive features on the application materials specified is not confirmed. technical result. Those. the claimed solution has features that are absent in the known technical solutions, and the use of these features in the claimed combination of essential features makes it possible to obtain a new technical result, therefore, the proposed technical solution could be obtained only through a creative approach and is not obvious to the average person skilled in the art, t .e. has an inventive step in comparison with the existing level of technology.

The quantitative content of the hydrogel components is optimal and is selected on the basis of numerous experiments.

Tests of the claimed drug were carried out on the basis of the St. Petersburg Clinical Hospital of the Russian Academy of Sciences and on the basis of the St. Petersburg Clinical Hospital No. 122 named after L.G. Sokolov.

Before using the product, the wounds were cleaned of foreign bodies, blood clots to ensure maximum contact of the drug with the surface of the wound.

Dressing, hydrogel, anti-burn sterile dressings were used in 15 patients (RAS hospital): in 10 patients in the treatment of granulating long-wound wounds; in 5 patients in the treatment of thermal burns.

Example 1. Patient N, 53 years old, as a result of a domestic fire received a burn (flame) of both upper extremities of the 1st-2nd degree, the burn surface area was 5%. Upon examination, the condition is satisfactory. For organs without features. Locally: hyperemia, moderate swelling of the skin, in some places the epidermis detachment with the formation of blisters. For the purpose of local conservative treatment of burn wounds, the anti-burn hydrogel "Lyoxazine-SP" was used, a positive effect was noted already with a single use of the drug. Complete healing of wounds was noted by 7 days, without scarring.

Example 2. Patient K., 62 years old, received a burn of boiling water on the right lower leg and outer surface of the foot of the II-IIIA degree. The wound surface area was 3%. Within 10 days of the application of symptomatic therapy, dressings with solutions of antiseptics, drying of burn wounds, positive dynamics were noted, however, the growth of granulations was slowed down. Locally: de-epithelized wound surface, moist, pale pink with a touch of fibrin, without mucopurulent discharge, sensitivity preserved, moderate swelling of the surrounding tissues. Local conservative treatment of burn wounds using napkins with anti-burn hydrogel "Lyoxazine-D-Gel". On the 17th day after the injury, complete epithelization of burn wounds was noted.

In hospital No. 122, hydrogel dressings were used in conservative therapy in 12 patients, 3 of them showed long-term skin wounds, and 9 patients were used to treat burns.

Example 3. Patient P., 39 years old, received a burn with boiling oil of the left forearm and hand II-IIIA degree, with an area of damage of 2%. The patient was admitted 2 days after the injury. The burn wound was characterized by de-epithelial areas, with moderately purulent discharge, swelling of the surrounding skin was noted. Antibacterial, symptomatic therapy was prescribed, the anti-burn hydrogel “Lyoxazine-Gel” was used as a local treatment for the burn wound, epithelialization sites were noted on days 10-11, and on day 19 the burn wound was completely epithelized.

It was noted:

- the use of funds is consistent with the stated evidence;

- the quality of packaging, labeling meets modern standards;

- the positive effect of exposure to wound surfaces is already apparent with a single use of the product;

- the tested dressings are easily applied to wound surfaces of any configuration, without leaving uncoated areas;

- the use of the product helps to reduce exudation from wound surfaces, accelerates the appearance of granulations and zones of epithelization, reduces the healing time;

- work with the product is convenient for staff;

- medical personnel did not have any difficulties with the product;

- there were no complications, allergic reactions in patients and staff;

- instructions for use are informative.

The use of the claimed means allows the use of anti-burn hydrogels in first aid for local burns of various etiologies, including radiation, at all stages of medical care, as well as the treatment of places of insect bites. With the possibility of use in emergency medicine as a universal anti-burn agent.

Claims (5)

1. Hydrogel composition for the treatment of burns, containing immobilized active ingredient and auxiliary ingredients and a gel-forming component, characterized in that:
- as an active ingredient contains a medicinal substance of 2-allyloxyethanol in an amount of from 0.1 to 10.0 wt.%;
- as auxiliary ingredients contains a medicinal substance of lidocaine in an amount of from 0.1 to 5.0 wt.% or medicinal substances of lidocaine in an amount of from 0.1 to 5.0 wt.% and deoxinate in an amount of from 0.1 to 5, 0 wt.%;
- as a gelling component contains hydroxypropyl cellulose in an amount of from 0.1 to 5.0 wt.%. 2. The hydrogel composition according to claim 1, characterized in that the active ingredient includes 2-allyloxyethanol in a concentration of (4.0 ± 0.5)%. 3. The hydrogel composition according to claim 1, characterized in that the auxiliary ingredient includes lidocaine in a concentration of (2.5 ± 0.5)%. 4. The hydrogel composition according to claim 1, characterized in that the auxiliary ingredient includes deoxinate in a concentration of (0.3 ± 0.1)%. 5. Hydrogel composition according to claims 1 to 4, characterized in that it additionally contains at least one of the substrates: fabric or non-woven material, mesh fabric in their mass ratio to the gel-forming component as 1: 3 ... 1: 8.