SK288639B6 - Hydrogel-based biopolymers with extracts of salivary glands and intestines larvae of Lucilia sericata for use in larval therapy and composition for its base - Google Patents

Abstract

Described herein is a biopolymer hydrogel comprising xanthan gum and carubin in a weight ratio of 1: 1.6 to 1.6: 1, the combined content of both components in water being 0.5 to 2.6% by weight, and the drug component based on extracts of the salivary glands and gut of larvae of Lucilia sericata. Of a component forming the extracts of salivary gland and intestines prepared from larvae II. and III. stages of Lucilia sericata larvae of flies high proteolytic and antimicrobial activity of extracts of 10 mg extract / 1 ml of gel. Also described is a preparation for the treatment of chronic wound wounds containing a hydrogel.

Description

The present invention relates to a hydrogel based on biopolymers with salivary gland extracts and larvae of the larvae of Lucilia sericata for use in larval therapy. The hydrogel may advantageously be used for the treatment of chronic non-healing wounds in larval therapy where conventional pharmacological treatment has already failed. Maintains optimum humidity (even in dry wounds), autolytically removes necrosis and coatings, while not disturbing surrounding healthy cells. The hydrogel fills the wound in both the inflammatory and granulation phases. These are dry-wound wounds, necrotic wounds, mild to moderate seeding wounds of varying depth.

BACKGROUND OF THE INVENTION

Commercially available gels and gel coatings based on hydrophilic polymers with high water content and amorphous nature are known in the literature (Moody A. Use of a hydrogel dressing formanagementofapainful Ieg ulcer (Time study). Wound Čare. June 2006; 12-17; Balcieraková L Practical Physicians, 2013; 3 (1): 34-38; Vaseenon T at al.,: Off-loading total contact cast in combination with hydrogel and foam dressing for management of diabetic plantar ulcer of the foot. J Med Assoc Thai 2014; 97 (12): 1319-24; Williams C. Granugel: hydrocolloid gel, Br J Nurs 1996; 5 (3): 188, 190; Dumville JC, Stubbs N, Keogh SJ , Walker RM, Liu Z. Hydrogel dressings for treating pressure ulcers Cochrane Database Syst Rev. 2015 Feb 17; 2: CD011226; Kickhöfen et al., Chemical and Physical Properties of Hydrogen Wound Dressing, Biomaterials, 1986; 7 (l) Kokabia M. et al., ZM, PVA-clay nanocomposite hydrogels for wound dressing.European Polymer Joumal. 2007; 43 (3), 773- 781st

These modern dressings work on the principle of creating a humid environment in the wound, so it is also referred to as moist therapy. For wet therapy we use mainly hydrocolloids, alginates, semipermeable occlusive dressings, non-adhesive foam dressings, polyurethane foams and foils, hydrocellular materials and PUhydrogels manufactured by commercial companies such as Hartmann, BBraun, Johnson & Johnson, Lohmann & Rauscher, Conva Tec.

Patents WO 2007138361 A2, WO 03/075654 A2 and EP 1 222 258 B1 are registered abroad which relate to the treatment and cleaning of wounds by substances / enzymes by proteolytic activity, which are extracted from the larvae of the Lucilia sericata. However, they are separate salivary gland enzymes that are obtained and purified from Lucilia sericata larvae, the product of the present invention being an salivary gland and intestinal extract containing a complex of these enzymes and forming part of a biopolymers hydrogel.

Larval therapy (Maggot Debridement Therapy - MDT) has been developing as a treatment method in human medicine for the last two decades, and the results achieved are more than encouraging, often much better than using antibiotics. They are gradually looking for more effective and easier to accept, more comfortable l'onny larval therapy. Biopolymers-based hydrogel with salivary gland and intestinal larvae extracts of Lucilia sericata seems to be the most suitable. Proteolytic enzymes and a wide range of antimicrobial agents in the salivary glands of larvae, which contribute to disinfection, wound healing and new tissue growth, are the healing effects, while the hydrogel has very good adhesion to human skin, allowing the skin to breathe and thus prevent skin irritation, and its removal from the patient's skin is not painful. There are no known hydrogels prepared on a similar basis from the literature, only commercially available gels and gel coatings based on hydrophilic polymers of high water content and amorphous nature.

Some complications and side effects are also associated with MDT. These include light discomfort, odor when first larvae are changed and larvae leaking. Excessive pressure applied to wound portions can also kill the larvae in this area, leading to uneven wound debridement. The most common side effect associated with larval therapy is pain. As the larvae become larger, usually after 24 to 30 hours of therapy, some patients report either pulsating pressure pain or short-term, as if echo-biased, volatile pain. The patient's fear (so-called fuj factor) is not general and is often declared as a major deficiency of larval therapy. Fear and reluctance to assist in loading, tying, or eliminating the larval therapy cycle between nurses and healthcare professionals is a common experience. All of these complications can be managed by applying a biopolymers hydrogel with salivary gland and intestinal larvae extracts of Lucilia sericata to the wounds, with the same effect on wound treatment as the larvae, and with minimal side effects.

SUMMARY OF THE INVENTION

SUMMARY OF THE INVENTION The present invention provides a biopolymers hydrogel comprising xanthan gum and carobin in a weight ratio of 1: 1.6 to 1.6: 1, wherein the combined water content is 0.5 to 2.6% by weight, and the medicinal component based on salivary gland and intestinal larvae extracts of Lucilia sericata.

S 288639 B6

The active ingredient consists of salivary gland and intestinal extracts prepared from II. and ΙΠ. stage of fly larvae of Lucilia sericata with high proteolytic and antimicrobial activity of extracts, with a concentration of 10 mg extract / 1 ml gel.

The present invention also provides a composition for the treatment of chronic non-healing wounds, which comprises a hydrogel based on biopolymers.

The gel is prepared by dissolving xanthan gum and Locust Bean Gum (also called carobin, food grade E410) in distilled water at 80 ° C, while mixing with a 1.6: 1 to 1: 1.6 component ratio, both components in the water are 0.5 to 2.6% by weight. The complete multicomponent hydrogel is prepared by mixing sterile salivary gland and intestinal extracts prepared from larvae Π. and ΠΙ. Stage larvae of Lucilia sericata, where the proteolytic and antimicrobial activity of the salivary gland and intestinal extracts is highest. The larvae gradually release the contents of the salivary gut extracts into distilled water at 4 ° C for 1 hour, after which the secreted salivary gut extracts are collected into 2 ml tubes in which they are centrifuged for 60 min. at 14,000 rpm and 4 ° C, and subsequently the salivary gut extracts supernatant is filtered through 0.22 µm and 0.1 µm filters into lyophilization tubes in which it is frozen and then lyophilized completely to dryness. Dried salivary gland and intestine extracts are mixed into a 10 mg dry salivary gland extract and per ml of polymer gel, and the biopolymers-based multicomponent hydrogel with salivary gland extracts and larval larvae larvae is used in Lucilia sericata larvae. it has very good adhesion to both human and animal skin, allows the skin to breathe, thus preventing it from becoming steamy or irritated, while stripping it from the patient's skin is not painful.

DETAILED DESCRIPTION OF THE INVENTION

Example 1

The gel was prepared by dissolving 1.0 wt. % xanthan gum and 1.6 wt. Carbine (Locust Bean Gum) in distilled water containing 8% glycerin at 80 ° C with stirring. A highly viscous, elastic hydrogel having a relatively fast drying after application to the skin was obtained, while having a high elasticity even after drying.

Example 2

The gel was prepared by dissolving 0.32 wt. % xanthan gum and 0.18 wt. Carbine (Locust Bean Gum) in distilled water at 80 ° C, with stirring. A low viscous hydrogel was obtained with a relatively slow drying of the deposited skin layer, with very good adhesion.

Example 3

Salivary gland and intestinal extracts were prepared from Π. and ΠΙ. stage of the fly larvae of Lucilia sericata and blended into the prepared polymer gel of 0.32 wt. % xanthan gum and 0.18 wt. Carbine (Locust Bean Gum) in distilled water at 80 ° C. A low-viscosity biopolymers-based hydrogel with salivary gland and intestinal larvae extracts of Lucilia sericata for use in larval therapy was obtained, with relatively slow drying of the applied skin layer, with good adhesion thereto.

Industrial usability

The invention is advantageously useful for the treatment of long-term non-healing wounds for debridement, disinfection and wound healing in larval therapy. It is used alone or as a complementary method to MDT, mostly applied to smaller superficial wounds.

Claims (2)

Biopolymer-based hydrogel, characterized in that it comprises xanthan gum and carobin in a weight ratio of 1: 1.6 to 1.6: 1, wherein the combined content of the two components in the The water component is 0.5 to 2.6% by weight, and the active ingredient is based on the extracts of salivary glands and intestines of the larvae of Lucilia sericata. Hydrogel according to claim 1, characterized in that the medicament component consists of salivary gland and intestinal extracts prepared from II. and ΙΠ. stage of fly larvae of Lucilia sericata with high proteolytic and antimicrobial activity of extracts, with a concentration of 10 mg extract / 1 ml gel. Composition for the treatment of chronic non-healing wounds, characterized in that it comprises a hydrogel according to claims 1 and 2.