Agent for pyoinflammatory processes in soft tissues and mucous membranes

FIELD: medicine.

SUBSTANCE: therapeutic agent contains an alloy of polyethylene oxide of molecular weight 400 and 1500 as a base and comprises a combination of antiseptic, benzalkonium chloride and metronidazole as therapeutic ingredients. The invention provides preparing the therapeutic agent possessing the antimicrobial, sorption and wound-healing 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, 3 ex

 

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

The problem of treatment of purulent wounds is still relevant in modern medical practice. According to some authors from all surgical diseases of purulent complications account for 30-35%, and the mortality reaches 25%.

Without doubt, to achieve a positive result modern drugs should have the opposite effect and combine properties such as broad antimicrobial activity, high dehydrating ability, stimulation of tissue regeneration.

For today, the impact on the diversity of microorganisms that cause chronic inflammatory process in the soft tissues, used drugs for local application of antibiotic. However, it should be noted that the mass, and in some cases uncontrolled, their use leads to predominance in the wound are not sensitive or insensitive to them microflora. In this regard, in surgical practice in the treatment of local inflammatory processes, there has been increasing integration of the EU antiseptics and drugs.

The purpose of purulent exudate absorption and drainage of the wound surface in medicinal preparations (ointments, gels, etc. for outdoor applications currently widely used polyethylene oxides (PEO), carbon sorbents, derivatives of cellulose and other

The prototype of our invention is considered a drug, which includes (in mass fractions) of the antibiotic erythromycin estolate (1,0), antiseptics - chamomile extract (2,0) and a solution of methylene blue (0,004), and as the basis - alloy PEO-400 (79,2) and PEO-1500 (19,8), purified water (2,0) ("Experimental rationale for the use of new multi-ointment erythromycin of astolat and vibro-acoustic effects in the treatment of purulent wounds". Biryukov Century. And. Thesis Cand. the honey. n-K, 14.00.27-surgery, Kursk, 2006)

However, despite the fact that the antibiotic erythromycin is still used in clinical practice, its application is limited, as it quickly develops resistance of microorganisms, it has a relatively narrow spectrum of antimicrobial activity, instability suction, short duration of action. In turn antiseptics chamomile extract and methylene blue have not wide enough spectrum of antimicrobial action.

The technical result of the invention is to provide an effective medication the aqueous means, possessing antimicrobial, sorption and wound healing activity.

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 base alloy oxides with a molecular weight of 400 and 1500, characterized in that as a therapeutic component contains a combination of antiseptic benzalkonium chloride and metronidazole in the following mass proportions:

Benzalkonium chloride (Ph Eur monograf 0372)0,02-0,04
Metronidazole (FS 42-2283-93)1,0-2,0
The polyethylene oxide - M 400 m (FS 42-1242-96)80,0 to 90.0
The polyethylene oxide - M 1500 m (FS 42-1885-96)20,0-30,0

Characteristic of interest:

Benzalkonium chloride (Bensalkonium chlorid). Has microbiostatic and microbicides action on gram-positive, in large doses - on gram-negative bacteria and fungi of the genus Candida. It is also known as the preservative used to prevent microbial contamination during long-term storage of dosage forms, including ointments, gels, etc. in Addition to antiseptic that has a deodorizing action is. In addition, benzalkonium chloride is a cationic surface-active agent, which can influence the degree of grinding pharmaceutical substances, thereby increasing their bioavailability and efficacy.

Metronidazole. Antibacterial chemotherapeutic drug, a derivative of 5-intorimidazole, has a high activity against a broad spectrum of bacteria and protozoa. It is proved that the anaerobes have kept him 100% sensitivity. 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.

The oxides have a dehydrating effect, and in the festering wound it applies not only to its fabric, but it contains microbial cells. PEO-based dehydrates microbial cell, dramatically reduces its biological activity and weakens resistance to different drugs, resulting in significantly increased antimicrobial activity of many antibiotics, sulfonamides and antiseptics. Due to the ability of PEO to absorb exudate, and together with him and Mick is one of the toxins from the decay products of fabrics, biologically active substances of lysosomal enzymes and other mediators of the inflammatory process, "breaking" thereby its progressive course, they cause a potentiating effect on therapeutic effect of the medicinal product in General.

THE METHOD IS AS FOLLOWS.

The manufacturer of the medicinal product consists of three stages:

First stage: the calculated amount of polyethylene oxide M 1500 m (per M 1500 m) is melted in a water bath, after which it add the calculated amount of polyethylene oxide M 400 m (per M 400 m), stirred until a homogeneous mass is obtained alloy is cooled.

Second stage: the calculated number of sample metronidazole milled in the presence of the calculated amount of benzalkonium chloride. Third stage: powdered mixture of metronidazole and benzalkonium chloride in parts add alloy PEO M 1500 m and PEO M 400 m and homogenized to obtain a homogeneous mass.

EXAMPLE 1 (METHOD GET)

20,0 mass fractions of PEO M m 1500 melted on a water bath, then add in parts 80,0 mass fractions of PEO M 400 m and stirred until a homogeneous mass is obtained alloy leave to cool. Then crush the sample to 1.0 mass fraction of metronidazole in the presence of 0.02 mass fraction benzalkonium chloride. After that, the obtained sm is si metronidazole and benzalkonium chloride in parts add alloy oxides (PEO M m 400 and PEO M 1500 m) and homogenized to obtain a homogeneous mass.

EXAMPLE 2 (METHOD GET)

30,0 mass fractions of PEO M m 1500 melted on a water bath, then add in parts 90,0 mass fractions of PEO M 400 m and stirred until a homogeneous mass is obtained alloy leave to cool. Then crush the sample to 2.0 mass fraction of metronidazole in the presence of 0.04 mass fraction benzalkonium chloride. Then to the resulting mixture metronidazole and benzalkonium chloride in parts add alloy oxides (PEO M 400 m and PEO M 1500 m) and homogenized 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 was studied by the method of diffusion in agar (GF XII, 2007) against the test strains St. aureus ADS 6538-P, You. cereus was ATSS 10702, E. coli ATCC 25922, Proteus vulgaris and Pseudomonas aeruginosa was ATSS 9027, Candida albicans was ATSS 885-653. The determination results are presented in table.1.

From the data presented in table.1, it follows that the remedy for the treatment of purulent-inflammatory processes of the soft tissues and mucous membranes (example No. 1 and No. 2) has a strong enough b is oldnum action against all three test strains. The zone of inhibition of growth when studying the spectrum of antimicrobial activity is most pronounced against the test strains St. aureus ATCC 653 8-P, You. cereus ATCC 10702, Candida albicans ATCC 885-653, E. coli ATCC 25922, Proteus vulgaris, which is not inferior, and in some ways even surpasses zone of stunting in the study of the prototype (erythromycin estolate, chamomile extract, a solution of methylene blue alloy PEO M 400 m and 1500).

EXAMPLE 3 (EXPERIMENTAL USE)

Study of wound healing activity funds for the treatment of purulent-inflammatory processes of the soft tissues and mucous membranes (example No. 1 and No. 2) were carried out in the experiment on rats male 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 sets of 36 animals in each:

In 1 series (model) treatment was not conducted.

In the 2nd series (control) used for the treatment of ointment erythromycin estolate, chamomile extract, a solution of methylene blue, alloy PEO M 400 m and 1500 (prototype).

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).

The course of the wound process in the experiment, the selected animals were evaluated planimetric method (L. I. Popova), microbiological, histological methods. The 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 in all the series was marked hyperemia edges of the wound, swelling of the surrounding tissues, the bottom of the wounds were covered with fibrin with areas of necrosis, purulent discharge was observed.

In the course of treatment was cleansing the wound from purulent-necrotic masses, were stopped swelling, appeared granulation and 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), with 3 days 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.

Thus, the data obtained planimetric studies confirm the high effectiveness of the drug for treatment of purulent-inflammatory processes of the soft tissues and mucous membranes (examples 1 and 2) in the treatment of purulent wounds. To the 15th day a t the d ' wounds in the 3rd and 4th series decreased by 98,3%, that was higher than the speed of wound healing in an average of 2.8 times in comparison with 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, starting with the 5-day and throughout the observation period. In the 3rd and 4th series 5th day microbial colonization of RAS 2.2 times less than in the control series (64,12,82105, 57,33,17105and 1.40,21107CFU/g, respectively), on the 10th day - 4.1 times less than in the control series (18,91,54103, 16,12,21103and 7.60,93104CFU/g, respectively). It was thus established that the remedy for the treatment of purulent-inflammatory processes of the soft tissues and mucous membranes (examples 1 and 2) 2.2-4.1 times reduces microbial colonization of wounds in comparison with the prototype - ointment containing erythromycin estolate, chamomile extract, a solution of methylene blue, alloy PEO M 400 m and 1500.

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 surface of the wound covered in a thick fibrinous-leukocyte layer. Leukocytes are able RAS is hell. Connective tissue under leukocyte scab swollen, infiltrated isolated macrophages and segmented by leukocytes. Connective tissue loosened fibroblasts have basophilic cytoplasm distended and swollen core. There are foci of hemorrhage diapedetic character. The epithelium of distriict, the edge of his flat.

On the 3rd day in a group of animals in the control series on the surface of the wound - wide fibrinous-leukocyte scab under which there is active growth of granulation tissue. Granulation tissue abundantly infiltrated by leukocytes. Fibroblasts swollen with basophilic cytoplasm are heavyweights. Intercellular substance swollen, distended. On the 10th day of leukocyte-necrotic scab is completely separated from the surface of the wound. In the surface layer of the wound is determined fibroblasts and numerous macrophages. Infiltration is expressed weaker than on the previous day of observation. On the surface of the granulations continued growth of the epithelium. On the 15th day wound on the large surface epithelization. Beneath the epithelium is the connective tissue layered structure containing collagen fibers and infiltrated by leukocytes and macrophages. Swollen intercellular substance.

On the day 3 when using tools for the treatment of inflammatory Pro is escow soft tissues and mucous membranes (examples 1 and 2) there is a slight infiltration of fresh granulation by leukocytes. On the 10th day is the restoration of the skin (creeping epithelial shaft with the edges of the wound). On the 15th day wound epithelization, was observed almost complete recovery of the skin except its derivatives.

Thus, in the 3rd and 4th series notes faster cleaning of the surface of the wound from leukocyte-necrotic masses, active growth of granulations. By the 10th day, a significant portion of the wound or all of its surface epitelizirutmi.

Apply the remedy for the treatment of purulent-inflammatory processes of the soft tissues and mucous membranes (example 1 and 2) in the first and second phases of the wound healing process speeds up healing of wounds 2.8 times, 2.2 -4,1 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 in comparison with treatment with an ointment containing erythromycin estolate, chamomile extract, a solution of methylene blue, alloy PEO M 400 m and 1500 (the prototype of the invention).

For the treatment of purulent-inflammatory processes of the soft tissues and mucous membranes, containing as the base alloy oxides with a molecular weight of 400 and 1500, and includes as a therapeutic component combination antiseptic benzalkonium chloride and metronidazole in the following mass proportions:

Benzalkonium chloride0,02-0,04
Metronidazole1,0-2,0
Polyethyleneoxide M 400 m80,0 to 90.0
Polyethyleneoxide M 1500 m20,0-30,0



 

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