Antiseptic drug with haemostatic action, and method for preparing it

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to an antiseptic drug with haemostatic action for wound cleaning. The drug contains ingredients in the following ratio, wt %: an antimicrobial substance - 0.01-3, an active complex - 1-25, glycerol - 2-35 and water - up to 100. The antimicrobial substance is specified in a group consisting of cetyl pyridinium or cetyl methyl ammonium halogenide, chlorhexidine, miramistin and other quaternary bases applicable in medical practice to treat burns and to clean open wounds, and the active complex is presented by a haemostatic preparation in the form of a mixed-ligand chelated complex of zinc, ethylene diamine tetraacetic acid and ε - aminocapronic acid. The invention also refers to a method for preparing the antiseptic drug with haemostatic action. The method consists in the fact the active complex is prepared in a water-glycerol mixture while stirring by dissolving ε - aminocapronic acid, then zinc oxide, adding powdered ethylene diamine tetraacetic acid and after dissolved completely, adding a liquid solution of the antimicrobial substance in the water-glycerol mixture.

EFFECT: preparing the antiseptic drug with haemostatic action for wound cleaning.

2 cl, 9 ex

 

The invention relates to the field of medicine and more specifically to means used for antiseptic treatment of surface wounds and having hemostatic action.

Known for a wide range of disinfectants with high efficacy against pathogenic organisms. One of the most well-known disinfectant is hydrogen peroxide and products based on it (see, for example, Russian patent RU 2108810 [1]; EN 2183467 [2]; EN 2286145 [3]), compounds based on active chlorine, and their compositions (see, for example, American and Russian patent RU 2106311 [4]; EN 2192392 [5]; US 4536389 [6]; US 5114647 [7]). However, they may not be used as antiseptics for treatment of the skin, and especially open wounds, because of their toxicity and irritant properties.

Famous recipes with disinfectant that can be used for treatment of the skin. For example, a disinfectant based on chelate complex compound of the metal, ionic surfactants and aliphatic alcohol (see EN 2226109 [8]) has a very effective antiseptic, but no hemostatic properties.

Also known bactericidal composition "Ultracal" (see EN 2220724 [9]), containing collagen, methyluracil, metronidazole, sangviritrin and have the traveler antimicrobial and wound healing properties. However, this tool is difficult in composition and has a hemostatic effect.

Known hemostatic agents on the basis of collagen and gelatin, which introduced antiseptics, antibiotics, biostimulants and other auxiliary substances, but these funds do not have or have a weak antimicrobial properties. This applies to the so-called absorbable hemostatic sponge "Spongostan", based on the dried, purified gelatin foam (see http://www.legmed.ru/catalogue/details.html?item=5687&section=478 [10]).

Has also been described hemostatic agent based on zeolite and includes finely dispersed calcium carbonate, and the boehmite nanoparticles and polysaccharide and/or lignin (see EN 2333002 [11]). The drug does not cause pain and chemical burns of exposed tissues. But he has no antimicrobial properties.

To close the bleeding of wounds and cuts are also used medical hemostatic and wound healing product with anti-inflammatory properties (see EN 2328312 [12]). As a medicinal substance use sterile mechanochemically activated natural zeolite in the mixture with sea or salt lake or bischofite. This structure also does not have antimicrobial properties.

Closest to the claimed invention are drugs with combo receiver is authorized action, combining antiseptic and hemostatic properties. In particular, it is known hemostatic and antiseptic, in which as the primary active ingredient a complex partial iron containing salts of polyacrylic acid with antiseptic drug - 1,4-di-N-oxide, 2,3-bis-(oxymethyl)finokalia (see EN 2132678 [13]). The drug is highly soluble in water, has no smell and does not cause allergies. However, the proposed tool has a complex structure, expensive to manufacture, oxide of nitrogen-containing cycles are unstable, toxic and have weak antimicrobial properties. Another tool with a combined action, part hemostatic, antiseptic and vulnerary sponges are known from the patent RU 2226406 [14]. The proposed composition contains as the basis of gelatin, active component, kanamycin sulfate, furatsilin and additionally methyluracil, and is used as a hemostatic agent for the treatment of wounds of various etiologies. This drug also has a complex structure and is not a high bactericidal effect. In addition, there is an indication to the possible introduction of the preparation of formaldehyde in an amount up to 3% towards gelatino that is unacceptable, because formaldehyde is carcinogenic and banned.

The challenge aimed Appl is radiated to the invention, is to develop a homogeneous liquid composition used for surface treatment of open wounds, highly antiseptic, antibacterial and hemostatic activity, and method of producing such composition.

The technical result is achieved due to the fact that the composition comprising an antimicrobial substance, to provide hemostatic properties enter the hemostatic substance in the active complex based on ε - aminocaproic acid, and further added glycerin and water in the following ratio, wt.%:

The antimicrobial substance0.01 to 3
Active complex1-25
Glycerin2-35
Water100

As an antimicrobial substance in the composition is proposed to use a substance selected from the group comprising halides of cetylpyridinium or cetyltrimethylammonium, chlorhexidine, Miramistin and other Quaternary bases, which are used in medical practice for burns and the treatment of open wounds.

The presence in the formulation of the halides of cetylpyridinium Il is cetyltrimethylammonium, which simultaneously possess antibacterial properties and properties of surface-active substances, increases the efficiency of funds due to increased wetting properties at the surface of the skin.

As hemostatic agents use active complex based on ε - aminocaproic acid. He is smeshanoligandnye chelate complex of some metals, primarily zinc, ethylenediaminetetraacetic acid and ε - aminocaproic acid.

The use is described of chelate complex individually or in a mixture with ε - aminocaproic acid accelerates the processes stop bleeding open wounds compared using pure ε - aminocaproic acid. The combined effect of the active complex and ε - aminocaproic acid is to strengthen the hemostatic action and exert systemic hemostatic effect for bleeding, due to elevated fibrinolytic activity of plasma. The combined effect of antimicrobial substances, which simultaneously ionogenic surface active substance (SAS), and the active complex strengthens and bactericidal properties and hemostatic effect. Glycerin plays the role of solvent, softener, anti-freeze and reagent to obtain active included the sa using oxides of some metals.

Optionally, the tool may also include substances that provide local anesthesia.

The method of obtaining antiseptic hemostatic agents is consistently active complex and the introduction of the strict order of the other components of the formulation, namely, in a water-glycerol mixture under stirring to dissolve the first ε - aminocaproic acid, and then the metal oxide, preferably zinc, then sprinkled ethylenediaminetetraacetic acid and, after complete dissolution, the solution is poured antimicrobial agent in water-glycerol mixture.

The composition extends the temperature range for processing and enables effective surface treatment of open wounds at low temperatures.

The following examples illustrate methods of preparation and the effectiveness of the proposed composition for antiseptic processing, disinfection and stop bleeding on the surface of open wounds. These are typical examples of specific compounds according to the claimed invention does not in any way limit the scope of its legal protection.

Example 1.

To 120 g of the prepared water-glycerol solution containing 31,2 g of the active complex (26%), add at room temperature and vigorous stirring 4.8 g Ave varicella prepared water-glycerine solution, containing 0,26% pyridinium chloride. Get of 124.8 g of product composition: the antimicrobial substance is 0.01%, the active complex of 25%glycerol 2%, water the rest.

Example 2.

To 160 g of the prepared water-glycerol solution containing 1,72 g of the active complex (1,1%), add at room temperature and intensive stirring, 12 g of the previously prepared water-glycerol solution containing 0.15% of the pyridinium chloride. Get 172 g of product composition: the antimicrobial substance is 0.01%, the active complex of 1%, glycerin 35%, water the rest.

Example 3.

To 88 g of the prepared water-glycerol solution containing 1.26 g of the active complex (1,4%), add at room temperature and vigorous stirring of 37.7 g of the previously prepared water-glycerol solution containing 10% of pyridinium chloride. Get 125,7 g of product composition: antimicrobial substance 3%, active complex of 1%, glycerin 35%, the rest is water.

Example 4.

To 135 g of the prepared water-glycerol solution containing 1.5 g of the active complex (1,1%), add at room temperature and vigorous stirring 15 g of the previously prepared water-glycerol solution containing 0.1% cetyltrimethylammonium bromide. Receive 150 g of product composition: the antimicrobial substance is 0.01%, the active complex is 1%, glycerol 2%, the rest is water.

The study antiseptic properties tool.

In accordance with a possible area of application of means were conducted the following tests:

1. Antimicrobial activity assessment tools in vitro against E. coli 1257, S.aureus 906.

2. Antimicrobial activity assessment tools in vivo:

I. assessment of the effectiveness of disinfecting tools steps for hygienic treatment of hands;

II. Assessment of the effectiveness of disinfecting tools steps for partial sanitization of the skin.

Example 5.

Evaluation of antimicrobial activity in vitro ("drip method", "method cylinder") of the sample obtained in example 1 was carried out on solid nutrient media against the test microorganisms: 1257 E. coli, S.aureus 906. Used in the work 18-20 hour culture of the test organisms at a concentration of about 108±0,25·103CFU/ml

Evaluation of antimicrobial activity in vitro showed that the tested sample has antimicrobial activity against E.coli 1257, S.aureus 906. Zone of inhibition of growth of a number of cultures of test strains of bacteria when using the "method of the cylinders was (M±m) at exposure of 3 minutes: against E.coli 1257-7,3±0.1 mm, S.aureus 906-6,8±0,2 mm When the sowing of the zones of inhibition of growth in all cases were obtained negative results.

Example 6.

Assessment effectively the ti disinfecting action of the sample, obtained in example 2, for hygienic treatment of hands held against the natural microflora of the skin, including the wrist and forearm.

With the control arms, before it is processed by the claimed means did flush eye with a sterile gauze moistened with sterile solution of neutralizer (twin 80-3%, saponin of 0.3%lecithin, 0.1%, histidine 0,1%).

Then both hands were treated by the claimed means (the sample of example 2), after which the experimental hand made flush eye with a sterile gauze size 5×5 cm, soaked in a sterile solution of neutralizer. Gauze napkins were placed in wide-mouthed individual tubes with glass beads and 10 ml of sterile saline solution and washed for 10 minutes Then wash liquid was brought to 0.5 ml in a Petri dish and poured mesopartner agar, 0.2 ml on agar Endo and yolk-salt agar. Crops were incubated in a thermostat at 37°C for 48 hours, after which calculated the colony.

Studies have shown when conducting decontamination of the skin against the natural microflora, the use of the test tool allows you to reduce the level of microbial contamination of the skin against gram-positive microflora 99.5% and infection by gram-negative microflora - 100% (as in natural and artificial contaminate the skin).

Example 7.

Evaluation of the effectiveness of the disinfecting action of the sample obtained in example 1, with partial sanitization of the skin was performed in experiments regarding artificially contaminated hands culture of test strain.

On the inner surface of the skin of the forearm of the hand was dealt and evenly distributed in 1 ml of suspension daily broth culture of E. coli 1257 grown in an incubator at 37°C and containing 2×105CFU/ml

After drying the culture of the test strain (2-3 minutes) from the contaminated skin area of the forearm took erosion control sterile gauze cloth. Then this part of the forearm was treated with the inventive tool (sample of example 1) and after some time again did wash gauze cloth moistened with universal neutralizer. Next was carried out by seeding a flushing fluid, incubated crops and considered the results.

Studies have shown that carrying out a partial cleansing of the skin reduces the level of microbial contamination of the skin by gram-negative organisms at 100% (with artificial contamination of the skin) (on regulatory requirements - not less than 99.99%).

Research hemostatic properties of the proposed drug.

The hemostatic effect of sample means was conducted in the accordance with the methodology Lookery (see patent RU2286569 [15]), which provides that in laboratory conditions take stable of 3.8%solution of sodium citrate and 1 ml of patient's blood, taken in the ratio 1:9, after conducting necessary for the patient koagulologicheskih analyses. Next injected dropwise 0.1-0.2 ml hemostatic means and with the help of glass rod all mix. Include a stopwatch and note the presence of haemostatic effect when blood clots within less than one minute.

Example 8.

In 1 ml stable of 3.8%solution of sodium citrate patient's blood, taken in the ratio 1:9, after conducting necessary for the patient koagulologicheskih analyses, dropwise introduced a 0.1 ml sample from example 4) and mixed with a glass rod. The formation of blood clots occurred in 42 seconds.

Example 9.

In 1 ml stable of 3.8%solution of sodium citrate patient's blood, taken in the ratio 1:9, after conducting necessary for the patient koagulologicheskih analyses, dropwise introduced a 0.1 ml sample from example 3) and mixed with a glass rod. The formation of blood clots occurred within 35 seconds.

From the conducted research it follows that the claimed product has a pronounced total antimicrobial and hemostatic effects. As described in the reamers method allows you to get a new antiseptic agent with hemostatic effect.

The obtained results allow to recommend the use of processing AIDS for bleeding wounds and cuts, skin treatment surgical field of skin treatment injection fields, sanitary treatment of wound skin.

The proposed tool can be used as a universal disinfectant, sterilizing, antibacterial and hemostatic agents in outpatient, inpatient, and in the field to provide first aid in case of accidents, accidents and calamities by ambulance workers, medical staff, employees of Ministry of emergency situations, the public.

Thus, the presented data support the feasibility of the invention, the claimed advantages of the proposed antiseptic funds with hemostatic effect and method of its production.

1. Antiseptic with hemostatic effect, contain an antimicrobial substance, the active complex, glycerin and water, characterized in that as an antimicrobial substance in the tool used substance selected from the group comprising halides of cetylpyridinium or cetyltrimethylammonium, chlorhexidine, Miramistin and other Quaternary base, used in medical practice for burns and the treatment of open wounds, as well as sports the complex used hemostatic product in the form of mixed-ligand chelate complex of zinc, ethylenediaminetetraacetic acid and ε-aminocaproic acid in the following ratios, wt.%:

The antimicrobial substance0.01 to 3
Active complex1-25
Glycerin2-35
Water100

2. The method of obtaining antiseptic funds with hemostatic effect according to claim 1, consisting in the successive reception of the active complex and the introduction of the strict order of the other components of the formulation, characterized in that for obtaining the active compound in water-glycerol mixture under stirring to dissolve the first ε-aminocaproic acid, then zinc oxide, and then sprinkled ethylenediaminetetraacetic acid and, after complete dissolution, the solution is poured antimicrobial substance in a water-glycerin mixture.



 

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, R1, R2 and R3, optionally simultaneously represent hydrogen. C1-C5alkyl, C3-C5alkenyl or C3-C5-alkynyl; R4 represents hydrogen, a halogen atom, hydroxyl, C1-C3alkyl, C1-C3alkyloxy; R5 represents hydrogen, C1-C3alkyl, the group -C(O)R6;R6 represents hydroxyl, C1-C5alkyloxy, C3-C5alkenyloxy, C3-C5alkynyloxy optionally substituted by an amino group wherein the substitutes optionally identical are specified in hydrogen, C1-C3alkyl optionally substituted by a mono- or dialkylaminogroup, an alkyloxygroup, 5-6-member saturated heterocyclyl containing 1-2 heteroatoms specified in nitrogen and oxygen: pyridyl, phenyl optionally substituted by 1-3 methoxygroups; or optionally substituted 6-member, optionally annulated with 5-member unsaturated heterocyclyl, saturated heterocyclyl containing 2 nitrogen atoms wherein the substitutes are specified in C1-C3alkyl optionally substituted by 5- member heteroaryl containing 1-3 heteroatoms specified in nitrogen and oxygen; or 6- member optionally saturated heterocyclyl containing 1-2 nitrogen atom optionally substituted by C1-C3alkyl, oxo, optionally substituted by phenyl; a dashed line with an accompanying continuous line represents a single, double or triple bond.

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6 tbl, 2 ex

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