Haemostatic anti-burn wound-healing composition

FIELD: medicine.

SUBSTANCE: invention relates to a haemostatic anti-burn and wound-healing composition in the form of a hydrogel, which contains an active gel-forming component, a plasticiser, active and auxiliary components, namely a water-soluble heteropolymer of chitosonium salt in an amount from 1.0 to 10.0 wt %, a dexpanthenol substance and/or a 2-allyloxyethanol substance in an amount from 1.0 to 10.0 wt %, immobilised medicinal substances of aminocaproic or tranexamic acid in an amount from 0.1 to 5.0 wt % and calcium chloride in an amount from 0.05 to 2.0 wt %, immobilised medicinal substances of lidocaine or anylocaine in an amount from 0.1 to 5.0 wt % and chlorhexidine in an amount from 0.005 to 0.1 wt % and water.

EFFECT: extension of exploitation possibilities in stopping external capillary bleedings, local treatment of injured skin, non-healing wounds and local burns.

10 cl

 

The invention relates to medicine, namely to pharmacology, and in particular to means used in the extreme, sports medicine, and surgery and traumatology, to provide the first, primary health and emergency care for injuries and damages, accompanied by bleeding, burns and require local treatment.

The claimed composition and products based on it are designed for use in hospitals, in field conditions and individual use in the home.

Known hemostatic burn-wound healing composition containing the active gel-forming component, an active plasticizer, active and auxiliary ingredients (patent US 20100316739, IPC A61L 15/00, 2010). This solution is the closest to the claimed invention, therefore, it is taken as a prototype.

The disadvantage of the prototype is a low efficiency to stop bleeding in skin injury.

The technical result when using the claimed invention is the enhanced operational capabilities at the stop of the outer capillary bleeding, local treatment of damaged skin, non-healing wounds and burns local.

Below is General and private significant features that characterize the reasons for the about-effect relationship of the essential features of the invention with the specified technical result.

Hemostatic burn-wound healing composition comprises an active gel-forming component, an active plasticizer, active and auxiliary ingredients. As an active gel-forming component contains water-soluble heteropolymer salt hitzone General formula:

[(C8H13NO5)1-m(C6H12N+O4X)m]n,

where (C8H13NO5) - Brutto-formula elementary level chitin;

(C6H12N+O4X-) - Brutto-formula elementary level salt chitosane;

X-- chloride, formate, acetate, oxalate, succinate, citrate, glycolate, or lactation,

m - deacetylation of chitin from 0.7 to 1.0;

n is the number of elementary units in heteropolymer from 10 to 1000, in an amount of from 1.0 to 10.0 (wt.%);

- as an active plasticizer contains a medicinal substance of dexpanthenol and/or 2-allyloxymethyl in the amount of from 1.0 to 10.0 (wt.%);

as active ingredients contains immobilized drug aminocaproic or tranexamic acid in an amount of from 0.1 to 5.0 wt%) and calcium chloride in amounts of from 0.05 to 2.0 (wt.%);

as auxiliary ingredients contains immobilized drug substance lidocaine or amylocaine in the share of the ve from 0.1 to 5.0 wt%) and chlorhexidine in the amount of 0.005 to 0.1 (wt.%).

Active gel-forming component consists of heteropolymer formate chitosane with a degree of deacetylation of at least 85% and a molecular weight of 100-300 kDa at a concentration of (4±2)%.

Active plasticizer consists of dexpanthenol in concentration (4±2)%. Active plasticizer consists of 2-allyloxymethyl in concentration (4±2)%.

The active ingredient consists of immobilized drug aminocaproic acid concentration (1,6±0,6)%.

The active ingredient consists of immobilized drug substance calcium chloride in a concentration of 0.8 ą 0.3)%.

Auxiliary ingredient includes immobilized lidocaine concentration (1,6±0,6)% or immobilized anakain concentration (1,6±0,6)% or immobilized chlorhexidine concentration (0,05±0,02)%.

The rest is water.

Hemostatic burn-wound healing composition further comprises at least one substrate selected from the group of fabric or non-woven fabric, mesh fabric at the weight ratio of substrate: hydrogel from 1:1 to 1:12.

A comparison of the claimed technical solution to the prior art known from scientific, technical and patent documentation on the priority date in the main and adjacent sections revealed no means having characteristics identical to all the signs containing the MSA as proposed by the applicant claims, including characterization purposes. I.e. the set of essential features of the claimed solution was not previously known and is not identical with any known technical solutions, therefore, it corresponds to a condition of patentability "novelty".

This solution is industrially applicable, as in the description and title of the invention indicated his appointment, it can be carried out industrially and used to treat burns, workable, feasible and reproducible, and features of the device allow to obtain the desired technical result - enhanced operational capabilities at the stop of the outer capillary bleeding, local treatment of damaged skin, non-healing wounds and burns local, i.e. they are significant.

The invention as it is characterized in each of the claims, may be made by using the tools and methods described in the prototype and the examples below.

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

Analysis of the known technical solutions in this field of technology has shown that the proposed technical solution is not necessary for the expert in the obvious way from the prior art, as it is not detected solution have signs consistent with the distinctive features of the invention and is not confirmed by the popularity of the influence of distinctive features provided in the application materials technical result. I.e. the claimed solution has features that are missing in the known technical solutions, and the use of these characteristics in the stated essential features gives you the opportunity to gain new technical result.

Therefore, the proposed solution can be obtained only by creativity and not obvious to a person skilled in this field, i.e. it has an inventive step compared to the current level of technology.

To assess the effectiveness of hemostatic burn wound hydrogel composition of the above composition were performed preclinical studies on medium-laboratory animals - rabbits of the chinchilla breed. For this experiment consisted of 20 rats of both sexes weighing from 3.2 to 5.0 kg Before the start of the experiment the animals were randomized into two groups: experimental and control, 10 animals in each. In the experimental group to stop bleeding used the claimed composition in controlling cotton-gauze bandage. The study design was to create a model of wound capillary to which Owatonna. Previously, animals were injected anaesthesia by intravenous drug Xila 0.15 ml/kg of body weight of the animals. On the hind foot shaved plot of 100 cm2then after processing operating margins of 0.25% solution of aqueous Chlorhexidine was applied in-plane wound by cutting with a knife Tersa epidermal-dermal layer of a thickness of 2-5 mm and an area of approximately 20 cm2. In the formed planar wound with extensive surface area (relative to the surface of an animal body) capillary bleeding. After receiving bleeding through 5, was used hemostatic agents. When using the preparation according to the invention the claimed composition of the following composition:

- heteropolymer salt chitosane with a degree of deacetylation of chitin 0.9 and the number of elementary units in heteropolymer 150- < = 5.%;

active plasticizer - dexpanthenol - 5.%;

- substance aminocaproic acid - 1,Mas.%;

- substance calcium chloride 0,Mas.%;

- substance lidocaine - 1,Mas.%;

- substance chlorhexidine - 0,MS.%;

- the rest is water.

put on the wound, which was secured multiple rounds of bandage without pressure. The effectiveness of hemostasis was assessed after 3 min, after removing the bandages. The experiment found that in the experimental group after exposure savannaheste hemostasis was achieved in 100% of cases.

On examination, the wound was determined by multiple small thrombosed vessels leaking blood is not marked. In the control group, which used ordinary cotton-gauze bandage, through control hemostasis was achieved only in 4 cases (40,0%) out of 10. It should be noted that cotton-gauze bandage sticks to the bottom of the wound and removal of tear formed clots, resulting in a marked relapse capillary bleeding. The data obtained statistically significant (test Fisher, p<0,05).

The basis of the analysis of the effectiveness of wound healing properties of the invented composition on the experience of surgical and conservative treatment of patients with nonhealing the decubitus sacral area in the Department of purulent surgery city hospital. An experimental group, which used the composition, amounted to 24 patients, control 18 patients. The majority of patients (83,2%) was over 50 years old and suffered severe comorbidity, complicating the course of the wound process: hypertension, chronic heart failure, diabetes mellitus type I and II. Significant differences by gender and age in representative groups have been identified. All patients underwent a comprehensive examination, including clinical, instrumental and laboratory methods of research. Criterion including the deposits in the study was the presence of superficial decubitus sacral area up to 30 cm 2in necrotic and deathly-inflammatory stages after stage necrectomy.

In the treatment of patients of the main group were used for local drug application in the control group used a combined dressings "Alginat". The clinical course of the wound process was evaluated on the basis of complete cleansing of the wounds of necrotic tissue, the appearance of the granulation early epithelialization of wounds, subacute phenomena perifocal inflammation. In both groups, were also implemented systemic antibacterial therapy, restoration of water and electrolyte balance, detoxification therapy and treatment of comorbidity.

In the experimental group of the drug on the application of the cleansing of pressure ulcers from the remnants of necrotic masses occurred in an average of 15.4±1.7 days. 16 observations with the appearance of granulation in the wound was noted beginning epithelialization. Next the results of all 24 observed patients of this group were satisfactory.

In the control group the average time of cleansing wounds and appearance of granules was 25.4±2.7 days. Marginal epithelization of wounds was observed in 9 cases. 2 In the control group the average time of cleansing wounds and appearance of granules was 25.4±2.7 days. Marginal epithelization of wounds was observed in 9 cases. In 2 patients the regional epitelial who was extremely slow, saw the emergence of areas of necrosis granulation.

In the future, were noted more successful results of skin plasty patients, local treatment which was used in the claimed composition. Apparently, this is due to microbial activity contained in the gel - cast components, the physical properties of the material.

During the studies it was noted pyrogenic, antigenic and toxic complications associated with the use of the above drug. The quantitative content of the components of the hemostatic burn-wound healing composition is optimal and confirmed the above representative sample of the numerous experiments.

The use of the claimed compositions and products on its basis can improve the efficiency and quality of care in hospitals, in the field and for private use in the home.

1. Hemostatic burn-wound healing composition containing the active gel-forming component, an active plasticizer, active and auxiliary ingredients, characterized in that as the active gel-forming component contains water-soluble heteropolymer salt hitzone General formula:
[(C8H13NO5)1-m(C6H12N+O4X-)m]n,
DG is (C 8H13NO5) - Brutto-formula elementary level chitin;
(C6H12N+O4X-) - Brutto-formula elementary level salt chitosane;
X-- chloride, formate, acetate, oxalate, succinate, citrate, glycolate, or lactate anions,
m - deacetylation of chitin from 0.7 to 1.0;
n is the number of elementary units in heteropolymer from 10 to 1000, in an amount of from 1.0 to 10.0 (wt.%);
- as an active plasticizer contains a medicinal substance of dexpanthenol and/or 2-allyloxymethyl in the amount of from 1.0 to 10.0 (wt.%);
as active ingredients contains immobilized drug aminocaproic or tranexamic acid in an amount of from 0.1 to 5.0 wt%) and calcium chloride in amounts of from 0.05 to 2.0 (wt.%);
as auxiliary ingredients contains immobilized drug substance lidocaine or amylocaine in the amount of from 0.1 to 5.0 wt%) and chlorhexidine in the amount of 0.005 to 0.1 (wt.%).
- the rest is water.

2. Hemostatic burn-wound healing composition according to claim 1, characterized in that the active gel-forming component consists of heteropolymer formate chitosane with a degree of deacetylation of at least 85% and a molecular weight of 100-300 kDa at a concentration of (4±2)%.

3. Hemostatic burns ranozazhivlyayuschee the composition according to claim 1, characterized in that the active plasticizer consists of dexpanthenol in concentration (4±2)%.

4. Hemostatic burn-wound healing composition according to claim 1, characterized in that the active plasticizer consists of 2-allyloxymethyl in concentration (4±2)%.

5. Hemostatic burn-wound healing composition according to claim 1, wherein the active ingredient consists of immobilized drug aminocaproic acid concentration (1,6±0,6)%.

6. Hemostatic burn-wound healing composition according to claim 1, wherein the active ingredient consists of immobilized drug substance calcium chloride in a concentration of 0.8 ą 0.3)%.

7. Hemostatic burn-wound healing composition according to claim 1, characterized in that the auxiliary ingredient includes immobilized lidocaine concentration (1,6±0,6)%.

8. Hemostatic burn-wound healing composition according to claim 1, characterized in that the auxiliary ingredient includes immobilized anakain concentration (1,6±0,6)%.

9. Hemostatic burn-wound healing composition according to claim 1, characterized in that the auxiliary ingredient includes immobilized chlorhexidine concentration (0,05±0,02)%.

10. Hemostatic burns R is Nazarovskaya composition according to claim 1 characterized in, that it further comprises at least one substrate selected from the group of fabric or non-woven fabric, mesh fabric at the weight ratio of substrate : hydrogel from 1:1 to 1:12.



 

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