Agent for pyoinflammatory processes in soft tissues and mucous membranes

FIELD: medicine.

SUBSTANCE: therapeutic agent contains carboxymethyl cellulose sodium salt as a base and a combination of antiseptic, 0.01% Myramistinum and metronidazole as therapeutic ingredients. The invention provides preparing the therapeutic agent possessing the antiseptic, wound-healing and sorption action on local pyoinflammatory processes in soft tissues and mucous membranes, used in surgery, dermatology, obstetrics and gynaecology, otorhinolaryngology.

EFFECT: agent possesses the higher efficacy.

2 tbl, 2 ex

 

The invention relates to medicine, namely to funds that have antimicrobial, wound healing and sorption effects on local purulent-inflammatory processes of the soft tissues and mucous membranes, used in surgery, dermatology, obstetrics and gynecology, otorhinolaryngology.

The actual problem of modern surgery is the issue of treatment of purulent wounds, which is associated with the prevalence of wounds of different etiology, septic complications, high mortality, high material costs of the treatment. According to some authors from all surgical diseases of purulent complications account for 30-35%, and the mortality reaches 25%.

Despite the development and introduction of new methods of treatment of purulent wounds, the use of drugs under the bandage is today the main due to its affordability, ease of use and economic benefits.

Among the drugs external application widely used ointments and gels on the basics, which do not injure the damaged surface when applied to the wound, provide drainage of wounds, and medicinal substances in their composition, provide the necessary therapeutic effect. Without a doubt modern drugs should have the opposite effect and combine properties such as wide what I antimicrobial activity, high dehydrating ability, stimulation of tissue regeneration.

Primary role in the treatment of purulent-inflammatory processes play an antibacterial agent, among which are currently much interest antiseptics and drugs, widely known and well established in surgical practice, in particular the group of imidazole.

For the introduction of active substances used basis, with not only a good consistency, atraumatic when smearing, but also fulfilling the role of drainage and absorption of purulent discharge from the wound. As such a framework is widely used alloys oxides, gels, cellulose derivatives and other

The prototype of the invention was the drug, which includes sodium hypochlorite gel polymer sodium salt of carboxymethylcellulose (Na) (patent for invention №2235535 from 2004.09.10 "Tool for local treatment of purulent-inflammatory processes of the skin and mucous membranes, the patentee Narocin I. I.).

Sodium hypochlorite, despite its activity against many gram-positive and gram-negative bacteria, most pathogenic fungi, viruses and protozoa, is the connection is very unstable, the efficiency of which is declining rapidly in the presence of blood or its components. Also what about the, it has a characteristic odor of chlorine and has high corrosion properties, which adversely affects the health service staff and patients.

The technical result of the invention is the creation of medicines, has antiseptic, wound-healing and absorption functions.

The technical result is achieved in that the means for the treatment of purulent-inflammatory processes of the soft tissues and mucous membranes contains as the basis of sodium carboxymethyl cellulose, characterized in that as a therapeutic component contains a combination of antiseptic 0.01% solution Miramistin and metronidazole in the following mass proportions:

Solution Miramistin 0,01%95,0-100,0
(FS 42-3498-98)
Metronidazole1,0-2,0
(FS 42-2283-93)
Sodium salt of carboxymethylcellulose4,0-6,0
(THE 6-55-221-1453-96)

The characteristics of the objects

Miramistin (benzyldimethyl[3-(myristoylation)propyl]ammonium x is ORed) - the original, patented medicine, antiseptic, belongs to the group of cationic surface-active substances, namely Quaternary ammonium compounds. Has a strong bactericidal action against gram-positive and gram-negative aerobic and anaerobic bacteria in the form of monocultures and microbial associations, including hospital with MDR strains to antibiotics.

Metronidazole. Antibacterial and antimicrobial drug, a derivative of 5-intorimidazole. The mechanism of action is the biochemical reduction of 5-nitro group of metronidazole intracellular transport proteins anaerobic microorganisms and protozoa. Restored 5-nitrogroup of metronidazole interacts with the DNA of the cells of microorganisms by inhibiting the synthesis of nucleic acids, which leads to the death of bacteria. Active against Trichomonas vaginalis, Gardnerella vaginalis, Giardia intestinalis, Entamoeba histolytica, Lamblia spp., and obligate anaerobes Bacteroides spp. (including Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp., Veillonella spp., Prevotella (Prevotella bivia, Prevotella buccae, Prevotella disiens) and some gram-positive microorganisms (Eubacter spp., Clostridium spp., Peptococcus spp., Peptostreptococcus spp., Mobiluncus spp.).

Sodium carboxymethyl cellulose (Na) soluble in water, in aqueous solutions of alkalis, organizedcategories and mineral oils not soluble. This sodium salt of carboxymethyl cellulose forms a viscous transparent solution, characterized by pseudoplasticity, and for some varieties of product and thixotropy (ie, the ability to spontaneously restore the mechanical impact of the original structure). In the form of a gel Na interacts with the tissues and the contents of the wound evenly across the wound surface, provides a quick and full delivery of drugs to the site of lesion, exhibits an osmotic effect when applied to the wound, absorbing wound.

The method is as follows.

The manufacturer of the medicinal product consists of two stages.

First stage: to the corresponding hinge sodium salt of carboxymethylcellulose add the calculated amount of 0.01% solution of Miramistin, mix and leave for days at temperature (4±1)°C for swelling and smooth;

Second stage: to pre-shredded hanging metronidazole in parts add the obtained gel sodium salt of carboxymethyl cellulose with a 0.01% solution of Miramistin and stirred to obtain a homogeneous mass.

Example # 1 way to obtain

To 4,0 mass fractions Na add to 100.0 mass fraction of 0.01% solution of Miramistin, mix to proceneonate mass and leave for days at temperature (4±1)°C, then shredded to 1.0 mass fraction of metronidazole in parts add the obtained gel sodium salt of carboxymethyl cellulose with a 0.01% solution of Miramistin and stirred to obtain a homogeneous mass.

Example No. 2 on the way to obtain

6,0 mass fractions N add 95,0 mass fraction of 0.01% solution of Miramistin, mix until smooth and leave for days at temperature (4±1)°C, then to pre-shredded 2,0 mass fraction of metronidazole in parts add the obtained gel sodium salt of carboxymethyl cellulose with a 0.01% solution of Miramistin and stirred to obtain a homogeneous mass.

Determination of microbiological activity funds for the treatment of purulent-inflammatory processes of the soft tissues and mucous membranes.

Antimicrobial activity funds for the treatment of purulent-inflammatory processes of the soft tissues and mucous membranes (sample No. 1 and sample No. 2) was studied by the method of diffusion in agar (GF XII, 2007) against strains St. aureus ATCC 653 8-P, You. subtilis ATCC 6633, You. cereus ATCC 10702, E. coli ATCC 25922, Proteus vulgaris and Pseudomonas aeruginosa ATCC 9027, Candida albicans ATCC 885-653. The results of determination of antimicrobial activity are shown in table.1.

From the data presented in table 1, it follows that developed the drug with adsto has higher antimicrobial activity, which is due to a combination of antiseptics and chemical, in respect of all the analyzed test strains. Area of stunting in the study of the spectrum of antimicrobial activity designed ointment (example No. 1 and example No. 2) is most pronounced against the test strains St. aure-us ATCC 653 8-P, E. coli ATCC 25922, which is 2.6 and 1.7 times greater than the area of stunting in the study of the prototype (sodium hypochlorite solution on Na), the differences between them are statistically significant.

An example of the experimental use

Study of wound healing activity developed drugs performed in experiments on male rats breed "Wistar", weighing 180-200 g, which was modeled purulent wound by the method of P. I. Tolstykh (1976). Experimental animals were divided into three series, 36 animals in each:

In 1 series (model) treatment was not conducted.

In the 2nd series (control) treated with protopapa (sodium hypochlorite on Na).

In the 3rd series treated tool for the treatment of purulent-inflammatory processes of the soft tissues and mucous membranes (sample No. 1).

In the 4th series treated tool for the treatment of purulent-inflammatory processes of the soft tissues and mucous membranes (example No. 2).

Ligation was carried out on a daily basis. The course of wound healing in experimental animals was evaluated planimeter the ical (method L. I. Popova), microbiological, histological methods, research results are processed statistically (calculated averages, criterion validity). The animals were sacrificed experiment by overdose of ether anesthesia on 1, 3, 5, 8, 10, 15 day.

After modeling on the 1st day all series wound was as follows: it was noted redness, swelling of the surrounding tissues and the edges of the wounds, the bottom was covered with fibrin with areas of necrosis, was observed abundant purulent discharge.

In the course of treatment was stopped swelling occurred cleansing the wound from purulent-necrotic masses, appeared granulation and began marginal epithelization.

Data planimetric studies indicate a more rapid decrease in the area of RAS in the 3rd and 4th series compared with model control (the original area of the wounds was 250 mm2), to the 8th day square RAS had statistically significant differences. The healing process proceeded faster in the 3rd and 4th series compared to the control and the model. The planimetric results of the study are presented in table.2.

When comparing series 3 and 4 statistically significant differences were not found.

Thus, the data obtained planimetric studies confirm the high the efficiency of the developed tools for the treatment of purulent-inflammatory processes of the soft tissues and mucous membranes (example No. 1 and No. 2). It contributes to the reduction of the area of RAS 99.2% on the 15th day, increases the rate of healing of 1.5 to 3.2 times compared to the control series.

These microbiological studies have shown that in the 3rd and 4th series of microbial infection of wounds is significantly less than in the control series since 3 days and during the whole observation period. In the 3rd and 4th series 5th day microbial colonization of wounds 5.4 times less than in the control series (15,2±2.2 x 105, 18,4±3,1×105and 8.1±2,1×106CFU/g, respectively), on the 10th day is 18.3 times less than in the control series (33,3±1,1×103, 40,1±2.4 x 103and 6.1±1.5 x 105CFU/g, respectively). Thus, it was found that for the treatment of purulent-inflammatory processes of the soft tissues and mucous membranes (example No. 1 and No. 2) 5.4-18.3 times reduces microbial colonization of wounds compared to the prototype (sodium hypochlorite on Na).

To fully assess the condition of the wound in the dynamics was used histological research method of wound biopsies, giving the opportunity to objectively assess the dynamics of the course of wound process.

On the 1st day after modeling the microscopic picture in all the series is as follows. The entire surface of the wound covered in a massive fibrinous-leukocyte layer. The majority of leukocytes in a state of decay. The connector is th tissue under leukocyte scab dramatically swollen, infiltrated segmented by leukocytes and isolated macrophages. The underlying connective tissue loosened fibroblasts its polymorphic, have basophilic cytoplasm and swollen, distended kernel. Blood vessels dilated. There are foci of hemorrhage diapedetic character. Edematous effects extend to the edges of the skin. The epithelium of distriict, vacuolation, the edge of his flat.

On the 3rd day in a group of animals in the control series, the wound is covered with a scab. The beginnings of granulation tissue infiltrated polymorphonuclear white cells. On the 10th day was the formation of epithelial shaft. Granulation tissue was separated from the intact dermis and infiltrated polymorphonuclear white cells. On the 15th day of wound defect was made bunches of immature collagen fibers. The surface of the wound defect covered by the epidermis, which was absent in the stratum corneum.

On the 3rd day when the treatment tool for the treatment of purulent-inflammatory processes of the soft tissues and mucous membranes (example No. 1 and No. 2) marked a sharp boundary granulation and intact skin, mild infiltration of polymorph nuclear leukocytes newly formed granulation. On the 10th day of the decrease in the volume of young collagen due to remodeling of the scar. Is the restore the skin at the angle of the wound defect. On the 15th day, there was complete recovery of the reticular layer of the skin except for derivatives: hair follicles and sebaceous glands.

In the series, where the treatment was carried out by means of treatment of purulent-inflammatory processes of the soft tissues and mucous membranes (example No. 1 and No. 2), indicated more rapid cleaning of the surface of the wound from leukocyte-necrotic masses (for 3 days) and more active growth of granulation tissue. The beginning of the growth of the epithelium at the edges of the wound begins in 3 days. By the 7th-10th days of a significant portion of the wound or all of its surface epitelizirutmi.

Thus, the application of the developed tools for the treatment of purulent-inflammatory processes of the soft tissues and mucous membranes in the first and second phases of the wound healing process speeds up healing of wounds 1.5-3.2 times, it helps to reduce the main stages of the course of the wound process in 1.3-2.3 times, 5.4-18.3 times reduces microbial colonization of the Russian Academy of Sciences, accelerates the formation and maturation of granulation tissue, promotes early and rapid epithelialization of the wound surface, has a high antimicrobial activity compared to treatment with the prototype of the invention (control series).

For the treatment of purulent-inflammatory processes of the soft tissues and mucous membranes, containing as the basis of sodium carboxymethyl cellulose and the with as a therapeutic component combination antiseptic 0.01% solution Miramistin and metronidazole in the following mass proportions:

Solution Miramistin 0,01%95,0-100,0
Metronidazole1,0-2,0
Sodium salt of carboxymethylcellulose4,0-6,0



 

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