Haemostatic plaster

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to medicine, namely to local haemostatic bandaging materials, and can be used in medical and preventive health care facilities. A haemostatic plaster contains a bottom layer of two design versions oriented to contact skin of various sensitivity: supersensitive skin requires thermomelting hypoallergenic non-continuous glue, while skin of moderate sensitivity, a glue of the following composition is used: lump rubber - 12.85 %, synthetic rubber - 12.85 %, pine rosin - 20.35 %, lanolin - 9.9 %, zinc oxide - 32 %, medical mineral oil - 11.3 %, antioxidant additive Agidol - 0.75 %, and a water-absorbing pad fixed on an adhesive layer, made of a nonwoven fabric and impregnated with a haemostatic compound of the following proportions: sodium carboxymethyl cellulose - 0.25-0.4 mg/cm2; calcium chloride - 1.3-1.4 mg/cm2, Furacilin - 0.003-0.005 mg/cm2. The adhesive layer coats the bottom layer either continuously, or in parallel stripes.

EFFECT: provided higher haemostatic properties of the plaster and reduced injures of the patient's skin with pain hypersensitivity threshold.

2 cl, 4 dwg, 2 ex

 

The invention relates to medicine, namely to hemostatic dressing tools, local action, and can be used as therapeutic and preventive health care facilities and at home.

A bandage is a strip of fabric or non-woven material with an adhesive layer. From the adhesive layer surface of the patch has a protective coating. Before applying the protective coating is removed and is appliqued onto the skin.

Widely known patches are rubber patches, which is a fabric substrate coated with a mixture of rubber and resin, balsam, fillers and antistatism (Ant IA and other drugs Technology, M.: Medicine, 1980, s).

Known hemostatic bandage (patent RF №2200583, IPC A61L 15/44, publ. 20.03.2003) from materials with a given absorption capacity. It is necessary to create volume sorption, ensuring the formation of a dense clot, as carriers are used, for example, non-woven textile materials (cholesterolemia, needle, net), as well as knitted fabric with a movable structure and sorption of water from 9-20 g/g Hemostatic substances deposited in a layer of polyethylene glycol with a molecular weight of 200-1200 to content on the surface of 0.02-0.3 g/cm2. Hemostatic bandage will gain additional atraumatic layer, made of a perforated film or mesh of a hydrophobic polymer, for example polypropylene, located at the side of the wound surface. Increased sorption of the liquid facilitates the application of polyethylene glycol (PEG) with a molecular mass of 200-1200 to content on the surface of the bandage of 0.02-0.3 g/cm2. The hemostatic properties of the bandage provides the carrier impregnated or applied on the surface of solutions of iron gluconate or lactate of iron to the surface concentration of 0.4-3.0 mg/cm2this concentration range is optimal for ensuring the process of blood clotting.

However, drug coverage unevenly distributed due to the mentioned heterogeneity of sorption materials that may cause heterogeneity of the treatment effect.

Known hemostatic tool for local action (patent RF №2142278, IPC AC 33/06, publ. 10.12.1999,) containing one or a mixture of several metal salts or a mixture with calcium chloride, Quaternary ammonium compound, dissolved in water or in physiological solution in the following ratio, wt.%: metal salts of 2,5-50,0, the Quaternary ammonium compound is 0.025 to 5.0; water-soluble Biosafety synthetic polymer in an amount of not more than 5.0; water or saline solution - the rest. The quality is TBE water-soluble biocompatible polymer used carboxymethylcellulose. As the basis for hemostatic composition were selected metal salts, such as AlCl3, 6N2Oh, FeCl3, 6H2O, CaCl2×H2O, AlK(SO4)2×12H2O, anhydrous ZnCl with TPL=293°C, combinations thereof, and other salts and complexes. As Quaternary ammonium compounds it contains 50%aqueous solution of alkyldimethylbenzylammonium chloride with alkyl radicals C10E21-C18H37, ammonium compound of the formula R1, R2, R3, R4N+X-where R is an alkyl, aryl, cycloalkyl, benzyl, heterocyclic residues, and X=Cl, Br, remnants of various organic and inorganic acids, such as Katanin AB.

However, this tool is used to prevent bleeding in the mouth, and to stop bleeding on the surface of the skin it is inconvenient to use.

Known rubber patch to the substrate, is made of acetate fabric with density 87-100 g/m2and elongation of not more than 25%. The adhesive layer contains a rubber, zinc oxide, lanolin, vaseline oil, pine rosin and antioxidant additive (USSR author's certificate No. 1316680, IPC A61L 5/00, publ. 15.06.87 year).

The disadvantages of this patch are the lack of hemostatic medicinal properties, damage to the skin of patients with increased threshold is alevai sensitivity in the presence of different types of pain irritation (mechanical, moist heat).

The closest technical solution to the stated (prototype) is a hemostatic patch (RF patent No. 2163147, IPC A61L 15/58, publ. 20.02.2001), consisting of hygroscopic atraumatic material, for example a multilayer gauze pads applied on the locking lamblasting tape, based on the impregnation of absorbent material with a solution of antiseptic substances that have a therapeutic effect to the wound of the patient, and dried. Moreover, hygroscopic material, for example a strip of six layers of gauze, impregnated once 1,5-3% solution of paracril (incomplete iron salt of acrylic acid), then press to humidity 45-85% and dried at a temperature of 90-100°C to obtain a residual moisture content of 3-7% and the content of paracril in the dried material in the range of 2.5-7%. Paracril - hemostatic preparation of local action with a non-specific mechanism of hemostasis, combines hemostatic effect with antibacterial and anesthetic effects. Paracril forms a clot with blood plasma proteins (even in the absence of fibrinogen), including the scarcity of factors of the blood coagulation system, and insoluble in water polycomplexes with proteins of different origin. Hemostatic effect is achieved quickly, re-bleeding are absent. Paracril there is xichen, no side effects on the contacting tissue. Not have a negative impact on the function of blood and the condition of internal organs.

However, this hemostatic patch does not have a sufficiently good hemostatic properties: time stop bleeding - 180-220 seconds. Veracel has a hemostatic effect is not due to the iron content, but due to the polyacrylic acid. In addition, the sorption capacity Marley insufficient for the formation of a solid clot in the wound and gauze are separated fibers, and change the bandage the wound, the injured.

The technical result of the present invention is to develop a more atraumatic hemostatic patch, fixing the area with a layer of adhesive provides contact with different types of human skin, and atraumatic hygroscopic gasket provides a faster (1.5-2.0 times) stop bleeding with simultaneous decontamination of the wound due to the formation at the contact of blood with the specified mesh lining polymer with aseptico.

This technical result is achieved by the fact that the hemostatic patch is characterized by the presence of a substrate made of a woven or non-woven material and having intermittent adhesive layer Allergy-free hot-melt glue or adhesive solid SL the second adhesive of the following composition and quantitative content, wt.%:

Natural rubber12,85
The synthetic rubber12,85
Lanolin9,9
Zinc oxide32,0
Vaseline oil health11,3
Pine rosin20,35
Antioxidant additive Agidol0,75

And on the adhesive layer of the substrate is fixed atraumatic absorbent pad made of nonwoven cloth impregnated as a hemostatic composition and the quantitative content of its components:

Sodium carboxymethylcellulose0.25 to 0.4 mg/cm2
Calcium chloride1.3 to 1.4 mg/cm2
Furatsilin0,003-0,005 mg/cm2

As Allergy-free hot-melt glue can be used, for example, medical hot-melt ghee is allergenic glue Novamelt PS 9500, or Novamelt PS 3001 German company Novamelt GmbH.

The substrate hemostatic patch has a rectangular, or rectangular with rounded edges, or square, or round, or oval shape, or form dumbbells.

Thus, the patch is a 3-layer construction, comprising an air - permeable substrate containing natural and/or synthetic fibers, which for patches-oriented contact with skin sensitivity caused intermittent adhesive layer hypoallergenic hot-melt glue and patches intended to come into contact with the skin of average sensitivity, the adhesive layer is applied in a continuous layer. The substrate with non-overlapping adhesive tracks provides the transmission of moisture vapour released by sweat glands, through the uncovered adhesive part and the substrate with a continuous adhesive provides the sorption of moisture by absorbing it with lanolin. Hemostatic properties of patch provided with absorbent pads saturated aqueous solution of sodium carboxymethyl cellulose, calcium chloride and furatsilina. The seal is made of non-woven cloth with atraumatic outer layer. The open part of the adhesive layer of the patch, advocating for the gasket and providing a fixation bandage on the wound, pukrittayakamee siliconized paper.

Figure 1 shows a diagram of the hemostatic patch with a continuous adhesive layer. Figure 2 - the same, the section a-A. figure 3 shows a diagram of the hemostatic patch by applying an adhesive layer to separate portions of the substrate. Figure 4 is a section along B-B.

The hemostatic patch (figure 1, 2) includes a substrate 1, made of woven or nonwoven material, and deposited on a substrate, the adhesive layer 2 in the amount of 0.03-0.07 g/cm2.

Example 1. In one embodiment of the patch on the substrate 1, the adhesive layer 2 applied as a continuous layer (Fig 1 and 2).

The adhesive layer has the following content, wt.%:

rubber natural Smoked sheets - 12,85

the synthetic rubber SKS-30 ARKN - 12,85

zinc oxide (zinc white) - 32,0

anhydrous lanolin - 9,9

vaseline oil health - 11,3

pine rosin - 20,35

additive antioxidant 4-methyl-2,6-directiony the butylphenol (Agidol-1) - 0.75 in.

In the manufacture of an adhesive mass of the solvent used oil solvent fraction 80/120 - Nefras C2-80/120, in accordance with TU 38.401-67-108-92.

As the substrate material used staple the canvas, medical gauze, acetate fabric and other applicable data for patch materials that meet the above characteristics.

The above composition izvesteni published in the patent of Russian Federation №2160578 C1, JSC "novosibkhimfarm", publ. 20.12.2000,

On the adhesive layer 2 is fixed hygroscopic strip 3 made of non-woven cloth impregnated as a hemostatic composition. The hemostatic composition has the following components:

the sodium carboxymethyl cellulose0.25 mg/cm2
calcium chloride1.3 mg/cm2
furatsilin0.003 mg/cm2

Example 2. In another embodiment, the adhesive of the adhesive layer 2 is applied in the form of separate strips 4, equal to the length of the substrate 1 and arranged in parallel to each other, or in separate bands (or spots) 4, located, for example, in a checkerboard pattern (Fig 3 and 4). Adhesive discontinuous layer contains a hot-melt hypoallergenic adhesive. As Allergy-free hot-melt glue can be used, for example, medical Allergy-free hot-melt adhesive Novamelt PS 9500 or Novamelt PS 3001 German company Novamelt GmbH.

On the adhesive layer 2 is fixed hygroscopic strip 3 made of non-woven cloth impregnated as a hemostatic composition. The hemostatic composition has the following components:

the sodium carboxymethyl cellulose0.4 mg/cm2
calcium chloride1.4 mg/cm2
furatsilin0.005 mg/cm2

The hemostatic patch has a rectangular shape (Fig 1 and 3), or rectangular with rounded edges, or a square shape or a round shape or an oval shape, or form dumbbells (not shown).

The outer surface of the medical hygroscopic strip 3 patches covered with a siliconized paper (not shown)attached to the Pro-laying parts of the patch, providing fixation of the patch on the skin.

Before applying the protective coating is removed and is appliqued on the patient's skin in the wound. Declare atraumatic hemostatic patch is intended for contact with different types of skin patients. For patients with sensitive skin adhesive layer of plaster is applied in the form of individual strips that are parallel to each other. For patients with skin the average sensitivity of the adhesive layer on the substrate is marked by a continuous layer.

Medical absorbent pad impregnated with an aqueous solution three is carboxymethylcellulose, calcium chloride and furatsilina, provides quick stop bleeding by forming a contact of blood with spacer mesh polymer, the resulting blended carboxymethyl cellulose and proteins, fibrin blood; providing decontamination of wounds is due to the contained in the strip asepsis - furatsilina.

In addition, the substrate with the adhesive layer in the form of separate strips ensures the transmission of moisture vapour released by sweat glands, through the uncovered adhesive part and the substrate with a continuous application of the adhesive layer ensures sorption of moisture by absorbing it with lanolin.

The technology of the hemostatic patch. Manufacturing technology patch includes the following stages.

Preparation of the substrate with the adhesive layer. For patches intended to come into contact with sensitive skin, time is carried out with use of the hot-melt adhesive on a special installation, allowing hot glue non-overlapping "tracks". Ready-to-roll substrates with an adhesive layer covered with a siliconized paper, transferred to the Department of cutting to obtain the tapes required for each type of patch width.

For patches that are intended for contact with the skin of average sensitivity, receiving adhesive is Loya is carried out by sesivany ingredients. The application of the adhesive mass on the fabric is held on sleeppromoting car. The finished tape in roll form are sent to the cutting Department.

The preparation of the impregnating treatment solution. Preparation of the solution is carried out in the reactor by dissolving in distilled water atricapillus, calcium chloride and furatsilina the next time quantitative component impregnating solution:

distilled water - 96,1 g

the sodium carboxymethyl cellulose 0.16 g

calcium chloride - 2.2 g

furatsilin - 0,1 g

Quantitative content furatsilina in the strip of non-woven fabric (Hfwr) in mg/g) is calculated by the formula:

,

where Dfur, the optical density of the solution at a wavelength of 375 nm;

50 - volume of distilled water taken for extraction (ml);

82,5 - specific absorption rate furatsilina at a wavelength of 375 nm;

m - hanging strips of nonwoven fabric.

Quantitative calcium chloride in the gasket (HK HL) in mg/g) is calculated by the formula:

,

where K is a correction factor to polyarnosti 0.05 M solution of the trylon B for calcium chloride (CaCl2×6H2O);

V - volume of 0.05 M trylon B, went to the titration, ml;

50 - volume of distilled water taken for extraction, ml;

10 - volume extrac is a, taken for titration, ml;

m - hanging strips non-woven cloth, g;

1000 is the conversion factor to mg/g

The manufacture of absorbent pads impregnated with active substances. The prepared solution is poured into a tub installation for impregnation. This installation is impregnated preform strip, pressing and drying. Soaked roll of nonwoven fabric is passed to the branch cutting for cutting strips for a particular type of patches.

Packing hemostatic patch. Packing is carried out at specialized under a specific item of patches of packaging machines. On the machine are mounted rolls basis of siliconized paper, strip and coils of the inner and outer packaging.

The machine is cutting, duplication, Assembly, packaging and labelling of patches.

Research hemostatic properties of the proposed patch showed that the time stop bleeding is 70-100 seconds.

1. The hemostatic patch, characterized by the presence of a substrate made of woven or non-woven material and having intermittent adhesive layer Allergy-free hot-melt glue or adhesive continuous layer of adhesive of the following composition and quantitative content, wt.%:

To ucuk natural 12,85
The synthetic rubber12,85
Lanolin9,9
Zinc oxide32,0
Vaseline oil health11,3
Pine rosin20,35
Antioxidant additive Agidol0,75

and on the adhesive layer of the substrate is fixed atraumatic absorbent pad made of nonwoven cloth impregnated as a hemostatic composition with the quantitative content of its components, mg/cm2:
Sodium carboxymethyl cellulose0,25-0,4
Calcium chloride1,3 -1,4
Furatsilin0,003-0,005

2. The hemostatic patch according to claim 1, characterized in that the substrate of the patch has a rectangular, or rectangular with rounded edges, or square, or round, or oval or dumbbell shape.



 

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