Surgical antiseptic glue "argacol"

FIELD: pharmaceutics.

SUBSTANCE: the present innovation deals with surgical, antiseptic, antiphlogistic and wound-healing glue that contains collagen hydrolyzate, sodium salt of alginic acid, catapol, dioxidin, poviargol; additionally, it contains glycerol, nipagin, nipasol and aqueous solution of sodium hypochlorite. The innovation provides increased antimicrobial activity and regulation of biodegradation rate of covering depending upon the level of inflammatory process in the wound that leads to faster wound healing.

EFFECT: higher efficiency of application.

4 tbl

 

The invention relates to the field of medicine and applies adhesive surgical antiseptic, anti-inflammatory, wound healing.

The essence of the invention is to develop a formulation of colloidal composition, forming on the surface of the wound elastic air - and water-permeable film has antiseptic, anti-inflammatory, wound-healing effect.

Currently, as a means for the treatment of microbial-contaminated wounds used drugs in the form of ointments and solutions based on polyvinylpyrrolidone iodine with a sufficiently broad spectrum of antimicrobial action (Betadine, Vocodin). However, their use is limited due to possible allergic reactions, as well as in hyperthyroidism. There are expensive based ointment silver sulfadiazine (Dermazin, Siladen, Selvetarm, Sulfargin)intended for the treatment of burn wounds. Contraindications for their use are hypersensitivity to sulfa drugs, and severe liver disease and kidney (Mashkovsky PPM Medicines: a Guide to pharmacotherapy for doctors: In 2 hours - Vilnius, Publishing house of GAMTA, 1993. - 4.1). Ointment for the treatment of superficial wounds Bepanthene-plus (on the main page. Drugs in Russia M: OVPEE-Attraversare, 2000. - P.59), is not recommended in the case of large the area deep and heavily contaminated wounds.

Developed a wide range of film dressings containing adhesive layer of antimicrobial agents. Great spread to protect the skin, surgical wounds and punctures around the Central and peripheral venous catheters received film containing iodine and chlorhexidine.

One of the analogs of the present invention is an adhesive antiseptic wound-containing antiseptic Miramistin, ethyl alcohol and glue BF-6. Glue is antibacterial, antifugal effect, enhances the regenerative processes in the wound clean and protects wounds from infection. At the same time, glue antiseptic with Miramistin has a number of disadvantages, as it contains ethyl alcohol and airtight polymer BF-6. The scope is restricted to minor damage to the epidermis (scratches, abrasions), i.e. not the entire thickness of the dermis. Glue with Miramistin is not applied in the treatment of wounds of the soft tissues (patent RU 2185155 C2, And 61 To 31/14).

Another analog of the present invention are combined foam dressings, combine the positive properties of proteins and polysaccharides in the treatment of wounds: creating an environment for healing (alginates and chitosans) and education matrix for the growth of newly formed granulation tissue and (collagen).

For example, Algico - original domestic foam dressing containing from 25 to 75% of cross-linked collagen and from 75 to 25% (calcium alginate, respectively. To make the dressing antimicrobial properties in its composition can be enabled from 0.5 to 5% furagin potassium. It is established that the increase of collagen in the complex leads to an increase in its stability and structural strength. Inclusion in the dressing antiseptics (furagin and shikonin) and anesthetics (trimekainom) allows to obtain a biologically active composite foam dressings. Aligica well established in the treatment of infected and festering wounds, stimulating the formation and maturation of granulation and exerting a mild antiseptic effect (currently not available).

Fibracell - dried sponge containing fibers cross-linked collagen with the addition of 10% of a mixture of calcium-sodium salt of alginic acid. When applied to a wound, the film quickly becomes wet and is easily modeled, while maintaining their structural properties. Requires secondary and a pressure bandage and the retention layer. Fibracell is a foreign counterpart Algicola [Nazarenko GI, Shugurova PU, Glyantsev S. p. Wound. The bandage. Sick. - M.: Medicine, 2002. - S-175].

These coatings have a number of disadvantages: contains cross-linked collagen to slow biodegradation is analogo coverage, which in turn reduces the rate of formation of a matrix for the growth of newly formed granulation tissue. In addition, alogical without antiseptics has no antimicrobial activity, and in the presence of furagin and shikonin has weak antibacterial action.

For the treatment of wounds currently use two main types (type, shape) hydrogel dressing devices. One group of products has a fixed (crosslinked) three-dimensional macrostructure and is a transparent elastic plate of different thickness. Dressings of this type usually do not change their shape in the process of absorption of wound exudate, although it may swell and increase in volume. The swelling continues until the gel becomes fully saturated, i.e. no balance will be achieved between the bandage and the surrounding wound environment.

Products of the second type does not have a fixed structure and are amorphous substances that can swell upon contact with liquids. As absorption viscosity of these gels is reduced and they are spread across the wound, taking the form of all its recesses. Such amorphous hydrogel continues to absorb the liquid until then, until they lose their cohesive properties and will not be a solution of the polymer in the wound. The main mechanism of therapeutic action is ia hydrogels is to create under them on the wound moist environment, promotes healing of wounds.

In the first stage of wound process wet environment provides stimulation of autolysis and cleansing wounds: in the II - creates conditions for the growth and maturation of granulation; III - for the formation of a soft and elastic hem.

The ability of amorphous gels of rapidly releasing in the wound environment biologically active substances (BAS) makes them indispensable in the treatment of chronic wounds. Opportunities of hydrogel coatings depo-dressings with active substances, including antiseptics, are not fully disclosed. However, it is clear that before the advent of hydrogels with antimicrobial properties and their use on infected and festering wounds is possible only in limited cases or should be under the guise of systemic antibiotic therapy.

The mechanism of therapeutic action of hydrogels associated with their hydrating the wound and absorbing wound exudate ability. Increasing the concentration under hydrogel dressings hydrolases (collagenases) stimulates the exclusion of necrosis due to the autolysis, and engaging on the surface of the wound soluble growth factors, interleukins and cytokines promotes migration of keratinocytes and epithelization of the wound.

The closest analogue (prototype) of the present invention is Solcoseryl gel (Mashkovsky, 1993, part 2, s). The drug contains 8,3 mg of chemically and biologically standartizireba the frame deproteinizing of hemodialysate from the blood of dairy calves, as well as sodium carboxymethyl cellulose, propylene glycol, calcium lactate and parabens E and E; indicated for the treatment of nonhealing, especially weeping wounds of different origin, thermal, chemical and radiation burns.

At the same time Solcoseryl gel has several disadvantages. It has low microbial activity, very quickly biodegraders on the wound surface, is easily absorbed by covering the gel bandage, which leads to a decrease in antimicrobial and absorbent capacity of the product, may require more frequent imposition of gel, which significantly increases the cost of the healing process.

The technical result of the present invention is the enhancement of antimicrobial activity and regulation of the rate of biodegradation of the coating depending on the level of inflammation in the wound.

The technical problem of the invention is the creation of the adhesive surgical antiseptic (KHA) is achieved by the fact that developed on the basis of protein hydrolysate, polysaccharide of plant origin and antistatico it contains hydrolyzed collagen, sodium salt of alginic acid, katapola, dioxidine, poviargol, glycerin, nipagin, nipazol, an aqueous solution of sodium hypochlorite in the following ratio of components (wt.%):

hydroly is at collagen 50,0-80,0
sodium salt of alginic acid1,0-10,0
the katapola0,5-1,0
dioxidine0,5-2,0
poviargol0.5 to 2.0
glycerin1,0-3,0
nipagin0,002
nipazol0,002
an aqueous solution of sodium hypochloritethe rest is up to 100

KHA is prepared as follows: hydrolyzed collagen is mixed with an aqueous solution of sodium hypochlorite, which sequentially add other ingredients: sodium salt of alginic acid, as well as katapola, dioxidine, poviargol, glycerin, nipagin and nipazol, mixing thoroughly.

The final product is a biodegradable viscous homogeneous structure of the colloidal composition, forming on the surface of the skin elastic air - and water-permeable film can be easily removed with water or saline solution. The time of film formation on the wound is determined by the degree of hydration and dried for RAS at room temperature is 3 to 6 minutes.

The adhesive has good adhesion to the skin and tissues, provides additional fixation surgical dressings on the skin surface around the wound, has no toxic is about, irritating and allergenic effect on the skin, mucous membranes and muscle tissue. The glue has a strong antimicrobial activity against pathogens of infectious complications RAS (staphylococci, streptococci, gram-negative bacteria, spore-forming and etiology of anaerobes, fungi of the genus Candida, and others), anti-inflammatory and wound-healing effect. Glue provides aseptic conditions healing, protects the wound from external mechanical impacts, dirt and infection. Joint use of antiseptics with different mechanisms of action leads to a pronounced antimicrobial effect, and the ratio of concentrations of biopolymers (collagen and sodium alginate) provides adjustability of the rate of biodegradation of the adhesive, which in result helps to speed up the healing of wounds.

The invention is confirmed by the results given in the following tables.

Table 1 presents the results of a comparative study of the bactericidal effect of the adhesive surgical antiseptic and Solcoseryl gel. The latter is significantly inferior to the bactericidal effect of the claimed glue: the sizes of the zones of growth inhibition of the test organisms around samples KHA much more than around Solcoseryl gel.

Table 1

A comparative study of the bactericidal effect of the adhesive surgical antiseptic (KHA) and Solcoseryl gel (method of diffusion in agar)
The test microorganismThe zone of growth inhibition (mm)
KHASolcoseryl gel
S.aureus207
E.coli250
Ps.aeruginosa170
C.albicans150

Table 2 presents the rate of biodegradation of KHA and Solcoseryl gel. The rate of biodegradation Solcoseryl gel depends on the nature of the wounds; wounds with high levels of inflammation gel quickly turns into a liquid (for several hours). The rate of biodegradation KHA also depends on the nature of the wounds, but it is much smaller than similar that allows you to apply KHA once a day or in 2-3 days.

Table 2

The rate of biodegradation (hours) KHA and Solcoseryl gel on a variety of wound surfaces in patients
WoundKHASolcoseryl gel
Donor wound48-726
Burns:
II degree

IIIa degree


24-48

24-48


4

2
Infected traumatic wounds24-482
Festering wounds12-242

Table 3 presents indicators of microbial contamination of infected wounds treated with KHA.

Table 3

Microbial colonization of infected wounds. treated with surgical glue antiseptic
WoundThe number of patientsMicrobial colonization (CFU/cm2)
Before the treatmentAfter treatment (days)
5-710-1421-24
Donor261031010-
Burns:

II degree

IIIa degree


17

17


105< / br>
106


102< / br>
103


101< / br>
102


-

101
Infected and purulent post-traumatic36 106103102-

To ensure this indicator on donor wounds was 103CFU/ cm; in patients with II degree burns to 105CFU/cm2; IIIa degree - 106CFU/cm2; infected and purulent post-traumatic wounds - 106CFU/see

In the course of treatment of microbial infection of donor wounds decreased by 2 orders in 5-7 days of treatment and at 3-order - to 10-14 day. In the treatment of burn wounds II degree application KHA reduced microbial colonization by 3 orders in 5-7 days, and in 4 order to 10-14 day. Similar figures with burns IIIa degree was 3 order in 5-7 days, 4 order to 10-14 day 5 orders of magnitude - to 21-24 day. The treatment of infected and purulent post-traumatic wounds with application KHA has resulted in the reduction of microbial contamination 3 order in 5-7 days, and in 4 order to 10-14 day.

High antimicrobial activity KHA confirmed by the results of clinical criteria for the effectiveness of the treatment of various wounds (table 4).

Table 4

Clinical performance criteria for the treatment of various wounds adhesive surgical antiseptic (day)
WoundsThe number of sickCleansing woundsThe emergence of granules is th Beginning epithelialization
Donor wound264-54-56-7
The II degree burns174-54-56-7
Infected and purulent wounds364-54-56-7

The end of the healing (complete epithelialization) occurred at 10-12 days, which allowed to start preparing for the plastic, which showed 100% engraftment of autodermotransplantat.

Thus, the claimed invention in the form of a new medical adhesive is a highly effective wound adhesive agent with pronounced antimicrobial action with adjustable speed of biodegradation of the coating in the absence of toxicity and allergenic effects.

Adhesive surgical antiseptic-based protein hydrolysate, polysaccharide of plant origin and antiseptics, characterized in that it contains hydrolyzed collagen, sodium salt of alginic acid, katapola, dioxidine, poviargol additionally contains glycerin, nipagin, nipazol and an aqueous solution of sodium hypochlorite in the following ratio, wt.%:

Hydrolyzed collagen 50,0-80,0
Sodium alginate1,0-10,0
Glycerin1,0-3,0
The katapola0,5-1,0
Dioxidine0,5-2,0
Poviargol0,5-2,0
Nipagin0,002
Nipazol0,002
A solution of sodium hypochloriteRest



 

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