Composition for wound healing based on hyaluronic acid

 

(57) Abstract:

The invention relates to the field of pharmacology, and relates to a composition for wound healing. The invention lies in the fact that the composition for wound healing contains hyaluronic acid, a preservative is a mixture of 1% aqueous solution of sanguinarine and tincture of calendula 70% aqueous ethyl alcohol, antioxidant - vitamin b6the anesthetic - novocaine, excipient - distilled water or vaseline. The invention obespecivaet expanding Arsenal of tools with wound-healing effect. 2 C.p. f-crystals.

The invention relates to pharmacology, specifically to compositions for wound healing containing hyaluronic acid.

Hyaluronic acid is mucopolysaccharide built from units of D-glucuronic acid and N-acetyl-D-glucosamine and having a molecular weight of 60000 to 12000000 D, depending on the natural source selection: the vitreous body of the eye, synovial fluid, ridges cocks, umbilical cord, dermis, and so on

Pharmaceutical compositions on the basis of hyaluronic acid is widely known that due to its disinfectant, anti-inflammatory and wound healing daignostic etc.

Among all truly vast variety of pharmaceutical compositions containing hyaluronic acid, a great importance is given to compositions which include anesthetics and antiseptics.

Thus, U.S. patent N 5128326 (CL 514-54) known gel (aqueous solution) hyaluronic acid-containing antibiotic antiseptic gentamicin and used, for example, impregnation of cotton gauze in the treatment of wounds. In the PCT application N 98/17285 described solution of hyaluronic acid containing a local anesthetic: benzydamine or bupivacaine-and, as antiseptics, parabens are esters of para-hydroxybenzoic acid. Antiseptics in compositions containing hyaluronic acid or a salt thereof (sodium, zinc, cobalt), often serve as: a methyl or propyl ester of p-hydroxybenzoic acid (methyl - or propylparaben, U.S. patent N 5554598), parabens and benzoate natra (U.S. patent N 5079236), 2-mercaptoethanol, ascorbic acid and glutathione (U.S. patent N 4886786), paraben and benzyl alcohol (U.S. patent N 5529987).

Selected as the closest analogue composition in accordance with U.S. patent N 5234914 (CL 514-54) contains hyaluronic acid, a preservative is methylparaben and anesthetic - lidoca disease.

The invention aims to provide a composition for treatment of wounds containing hyaluronic acid, anesthetic and antiseptic and expanding Arsenal of healing tools.

The goal has been achieved thanks to the composition containing hyaluronic acid, anesthetic and antiseptic, in which the anesthetic presents novocaine, antiseptic mixture (1:1) 1% aqueous solution of sanguinarine and tincture of calendula (1:10) in 70% aqueous ethyl alcohol, and the composition further comprises an antioxidant - vitamin B6- when the following ratio of ingredients, wt. %:

Hyaluronic acid is between 0.8 and 1.2

A mixture (1:1) 1% aqueous solution of sanguinarine with tincture of calendula (1:10 to 70% aqueous ethyl alcohol) - 0,04 - 0,06

Vitamin B6- 0,008-0,012

Novocaine - 0,4 - 0,6

Excipient 100,

at the same time as excipient can be selected from any pharmaceutically acceptable base, but preferably distilled water or vaseline.

The practical application of such compositions involves wetting her gauze bandages (wipes) or applied to the gauze and overlaying the damaged area, it is possible to extemporanea use (PR is quadratic (protects from drying out) package. When using water as excipient not exclude the possibility of irrigation RAS (jet feed composition).

Included in the compositions sangviritrin (see M. D. Mashkovsky, "Drugs", part II, page 487, M.: Medicine, 1993) represents the sum of bisulfate alkaloids sanguinarine and Celerina contained in the plant maclee heart and maclee small-fruited, the poppy family. Sangviritrin exhibits antimicrobial activity against gram-positive and gram-negative bacteria acts on yeast and filamentous fungi. It is used, for example, if epidermin and other skin diseases like ringworm, eczema).

Tincture of calendula (see : M. D. Mashkovsky, decree. works, part II, page 491) contains flavonoids, carotenoids, saponins, tannins and because of its anti-inflammatory properties used for sore throat, cuts, for the treatment of purulent wounds, burns, etc.

Thus, the use of sanguinarine and tincture of calendula as antiseptics known; what is novel is the use of a mixture of the two called antiseptics in the specified ratio. Part of sanguinarine substances, which, with the production of the Loy hyaluronic acid, that provides extension (elongation) of their actions due to the slow leaching with exudate from a wound.

Vitamin B6as an antioxidant also has a prolonged effect in the presence of hyaluronic acid and a mixture of sanguinarine and tinctures of calendula, which probably can be explained by the interaction between the pyridine fragment molecules of vitamin B6and heterocycles in substances sanguinarine and calendula and structural units of hyaluronic acid.

The mass ratio between the ingredients selected in such a way that they provide the best therapeutic effect.

The invention is illustrated by the following examples of its implementation.

Example 1. In an enameled vessel with a capacity of 20 l load 10 liters (10 kg) of distilled water and then: 5 g of a mixture (1:1) 1% aqueous solution of sanguinarine and solution (1:10) calendula in 70% aqueous ethanol, 1 g of vitamin B6and 50 g of novocaine; the mixture is intensively stirred at room temperature until homogeneity and at low speed stirring to avoid the formation of foam) is injected in small portions (1-2 g) 100 g of hyaluronic acid, produced by LLC "Tula induga") stirring for 3 hours get slightly opalescent solution, which is Packed in bottles of 50 or 100 ml or refer to the step of receiving medical wipes.

Example 2. In an enameled vessel of suitable capacity transfer (perelavlivaet) the solution obtained in example 1, make 1 kg of medical gauze and incubated at a temperature of 20 2oC for 12 hours, stirring occasionally. Wet gauze remove and press on rolls up to a residual moisture content of about 60%, cut on napkins size 10x7, h or h cm, sew three and Packed in plastic bags.

Example 3. In the burn Department of the Tula region hospital in 311 patients aged 4 months to 88 years (202 men, 109 women) studied the effectiveness of napkins soaked with the composition of example 1 and prepared according to example 2. 57 patients had superficial burns II-IIIA degree, 254 - deep burns, takes from 2 to 60% of the body surface. Moistened composition napkins, due to the overall poor condition of patients, was used on the background of the complex treatment including intensive infusion-transfusion therapy, active and passive immunization, the use of immunomodulators, antibiotics, hormones, vitamins, desensibilization and antihistamines, digitalin is rovati "Clinitron" and other It is noted that the use of gauze bandages (napkins), when they are changed every 1-2 days, caused a decrease in the total number of microbial bodies on burn wounds with 1600 cm2up to 400 cm2(i.e. to 1000-10000 per 1 g of tissue mass), and the sensitivity of microflora to the impregnated composition gauze dressings were increased by the end of treatment (2 weeks later). Under the influence soaked compositions gauze bandages decreased edema and friability hypertrophic granulation, they oposals, not so much speaking above the surface of the wound and the amount of purulent discharge from them decreased. The granulation was acquired crisp, juicy, fine-grained view, the bleeding stopped.

1. Therapeutic composition for wound healing, containing hyaluronic acid, anesthetic and antiseptic, characterized in that as an anesthetic contains procaine, as an antiseptic, a mixture (1:1) 1% aqueous solution of sanguinarine and tincture of calendula (1:10) in 70% aqueous ethyl alcohol, and the composition further comprises an antioxidant - vitamin B6and excipient in the following ratio of ingredients, wt.%:

Hyaluronic acid is between 0.8 and 1.2

A mixture (1:1) 1% aqueous solution, e.g. sanguinarin>Novocaine - 0,4 - 0,6

Excipient 100

2. Therapeutic composition under item 1, characterized in that as excipient taken distilled water.

3. Therapeutic composition under item 1, characterized in that as excipient taken vaseline.

 

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