TWI516287B - Water colloid dressing and its preparation method - Google Patents

Description

Hydrocolloid dressing and preparation method thereof

The present invention relates to a hydrocolloid dressing, and more particularly to a hydrocolloid dressing having a polymeric film formed by in situ coating. The invention further relates to a method of preparing a hydrocolloid dressing.

Hydrocolloid dressings are a widely used wound dressing. Hydrocolloid dressings typically comprise a hypoallergenic hydrocolloid layer and a polymeric film overlying the hydrocolloid layer. Currently, in the preparation of hydrocolloid dressings, the polymer film is generally pre-extruded on a release paper or other base material, and then composited with the water colloid layer, and then the release paper or other base material is peeled off. Since the polymer film needs to be composited with the hydrocolloid layer after film formation, the hydrocolloid dressing formed by this conventional method has insufficient bonding force between the two layers, so that it is easy to cause a "bubble" problem during use. That is, bubbling occurs due to the two layers of detachment caused by the absorption of the wound exudate.

Therefore, it is desirable to provide a hydrocolloid dressing having a stronger bonding force between the hydrocolloid and the polymer film.

The present invention provides a hydrocolloid dressing comprising a hydrocolloid layer and a polymer film layer disposed on the hydrocolloid layer, wherein the polymer film The layer is formed by coating a polymer solution or a liquid polymer.

According to some embodiments provided by the present invention, when the hydrocolloid layer and the polymer film layer are peeled off, the ratio of the area of the peeled portion to the total area is less than 100%.

According to still other embodiments provided by the present invention, when the hydrocolloid layer and the polymer film layer are peeled off, the ratio of the area of the peeled portion to the total area is equal to 100%, and the peeling force is greater than 60 oz/0.5 in.

The present invention also provides a method of preparing a hydrocolloid dressing comprising: forming a hydrocolloid layer; coating a polymer solution on the hydrocolloid layer; and drying.

The present invention forms a hydrocolloid dressing having a stronger bonding force between the hydrocolloid layer and the polymer film layer by forming a polymer film covering the hydrocolloid layer by using an in-situ coating method, and preliminarily prepares the polymerization. The substrate material used in the material can reduce the process cost.

1‧‧‧ polymer film

2‧‧‧Hydrocolloid

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a schematic illustration of a process for preparing a hydrocolloid dressing in one embodiment of the invention.

Figure 2 is a schematic illustration of the preparation of a sample in the soak test of the present invention.

3(a) and 3(b) are photographs of the results of the immersion test of the examples and comparative examples of the present invention, wherein Fig. 3(a) is a polyurethane film surface, and Fig. 3(b) is a hydrocolloid surface, in which the photograph is from From left to right are Comparative Example 1, Example 1, Example 2, and Example 3.

4(a) and 4(b) are scanning electron microscope (SEM) photographs of a cross section of a hydrocolloid dressing in an embodiment and a comparative example of the present invention, wherein FIG. 4(a) is Example 1, FIG. 4(b) is Comparative Example 1.

The present invention provides a hydrocolloid dressing comprising a hydrocolloid layer and a polymeric film layer disposed on the hydrocolloid layer, the polymer film being formed by in situ coating. The invention also provides a method for preparing a hydrocolloid dressing.

The hydrocolloid dressing formed by the conventional method has insufficient bonding force between the two layers, and it is easy to cause a "bubble" problem during use, which may be caused by two reasons: the hydrocolloid layer swells after absorption, and the polymer film The layer is not; the wound exudate diffuses to a relatively weakly bonded position between the two layers, causing the two layers to separate and appear like a "bubble."

The invention adopts an in-situ coating method to directly coat a polymer solution or a liquid polymer on a hydrocolloid layer, and then the solvent is dried, and the polymer film layer is formed on the hydrocolloid in situ. Since the polymer solution or the liquid polymer is liquid when it is applied to the hydrocolloid, it can flow, so that it can be spread along the undulation of the surface of the hydrocolloid and fully contact with the surface of the hydrocolloid layer, and can be more firmly bonded when the film is formed. On the water gel. This can greatly increase the bonding force between the hydrocolloid and the polymer film. By this method, a hydrocolloid dressing with stronger bonding force between the two layers can be obtained, and the generation of "bubbles" during use can be reduced.

As used herein, the term "hydrocolloid" refers to a type of adhesive that contains a gelling agent and thus has a water absorbing function and is often used for wound care.

As used herein, the term "in-situ coating" refers to direct coating on a substrate rather than off-line coating.

The percentages, parts, ratios, concentrations, and the like herein are based on weight unless otherwise specified.

The present invention provides a hydrocolloid dressing comprising a hydrocolloid layer and a polymeric film layer disposed on the hydrocolloid layer, wherein the polymeric film layer is formed by coating a polymer solution or a liquid polymer.

In some embodiments of the present invention, since the bonding force between the hydrocolloid layer and the polymer film layer is very high, the two layers cannot be completely peeled apart; when the two layers are peeled off, the two layers are broken. The lower strength layer ("peeled layer") is broken, a portion of the stripped layer is peeled off from the other layer, and the other portion is still bonded to the other layer; that is, in these embodiments, when When the two layers are peeled off, the ratio of the area of the peeled portion to the total area is less than 100%. In some embodiments, the ratio of the area of the stripped portion to the total area is less than about 95%. In some embodiments, the ratio of the area of the stripped portion to the total area is less than about 90%. In some embodiments, the ratio of the area of the stripped portion to the total area is less than about 80%. In some embodiments, the ratio of the area of the stripped portion to the total area is less than about 70%. In some embodiments, the ratio of the area of the stripped portion to the total area is less than about 60%. In other embodiments, the ratio of the area of the stripped portion to the total area is less than about 50%. In still other embodiments, the ratio of the area of the stripped portion to the total area is less than about 40%. In some embodiments, the ratio of the area of the stripped portion to the total area is greater than about 5%. In other embodiments, the ratio of the area of the stripped portion to the total area is greater than about 10%. In again In other embodiments, the ratio of the area of the stripped portion to the total area is greater than about 15%. In still other embodiments, the ratio of the area of the stripped portion to the total area is greater than about 20%. The "area of the peeled portion" herein refers to the area of the portion that is no longer bonded to each other after peeling the two layers. The above "total area" and "area of the stripped portion" are calculated based on the area to which the peeling force is applied.

In some embodiments of the present invention, the bonding force between the hydrocolloid layer and the polymer film layer is relatively high, and it is possible to completely peel the two layers apart, and the peeling force is greater than about 60 oz/0.5 in; when this is When the two layers are completely peeled off, any of the two layers may be unbroken; that is, in these embodiments, when the two layers of the hydrocolloid dressing are peeled off, the ratio of the area of the peeled portion to the total area Equal to 100% and the peel force is greater than about 60 oz/0.5 in. In some embodiments, the two layers of the hydrocolloid dressing are completely peeled apart by a peel force greater than about 70 oz/0.5 in. In some embodiments, the peel force of the two layers of the hydrocolloid dressing is completely peeled off by greater than about 90 oz / 0.5 in. In some embodiments, the peel force of the two layers of the hydrocolloid dressing is completely peeled off by greater than about 110 oz / 0.5 in. In some embodiments, the two layers of the hydrocolloid dressing are completely peeled apart by a peel force greater than about 130 oz / 0.5 in. In some embodiments, the peel force of the two layers of the hydrocolloid dressing is completely peeled off to greater than about 150 oz / 0.5 in.

In some embodiments of the present invention, the present invention provides a hydrocolloid dressing comprising a hydrocolloid layer and a polymeric film layer disposed on the hydrocolloid layer, wherein the polymer film layer is coated with a polymer solution or a liquid Formed by a polymer. Hydrocolloid layer and polymer film in hydrocolloid dressing The bonding force between the layers, or the peeling force for peeling the two layers, is greater than or equal to the breaking strength of the hydrocolloid layer or the polymer film layer. In some embodiments, the bonding force between the hydrocolloid layer and the polymeric film layer in the hydrocolloid dressing, or the peeling force of the two layers is greater than or equal to the breaking strength of each of the hydrocolloid layer and the polymeric film layer. .

The material used to form the hydrocolloid layer comprises from 5 to 55% by weight of the gelling agent and from 10 to 90% by weight of the binder substrate, based on 100% by weight of the hydrocolloid layer weight.

The role of the gelling agent is primarily to provide water absorption, generally a hydrophilic polymer which has the ability to absorb liquids and which, due to its crosslinked structure, does not dissolve upon absorption but swells. Hydrophilic polymer compounds which can be used include natural, semi-synthetic or synthetic hydrophilic polymer compounds. Natural hydrophilic polymer compounds include polysaccharide polymers such as gum, gum arabic, guar gum, agar, starch, xanthan gum, dextran, etc.; and protein or polypeptide polymers such as gelatin, albumin, casein Wait. Semi-synthetic hydrophilic polymer compounds include carboxymethyl cellulose, sodium carboxymethyl cellulose, methyl cellulose, ethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, methyl hydroxypropyl fiber , sodium alginate, carboxymethyl starch, etc. The synthetic hydrophilic polymer compound includes an acrylic polymer (e.g., polyacrylic acid and polyacrylamide), polyvinyl alcohol, polyvinylpyrrolidone, polyethylene glycol, polyvinyl methyl ether, and the like. The above hydrophilic polymer compound may be used in a single form or in the form of a mixture of two or more kinds of hydrophilic polymer compounds.

Commercially available products may be used, examples of which include, but are not limited to, selected from One or more of the following: HS100000YP2 hydroxyethyl cellulose obtained from Clariant Chemicals (China) Co., Ltd., FH5000 sodium carboxymethyl cellulose or PE32 obtained from Weiyi Chemical (Suzhou) Co., Ltd. (China) FGX cellulose gum, croscarmellose sodium obtained from FMC BioPolymer (USA), hypromellose and hydroxyethyl cellulose obtained from Shanghai Helicient Chemical Co., Ltd. (China) Carboxymethyl starch from Fuhua Drier Factory (China), Gongyi City, Henan Province, or Luquasorb 1030 superabsorbent polymer from BASF (Germany).

The content of the gelling agent in the hydrocolloid layer is from 5 to 55% by weight, preferably from 10 to 50% by weight, more preferably from 20 to 40% by weight, based on 100% by weight of the hydrocolloid layer.

The role of the binder substrate is primarily to form and provide adhesion and softness. The binder substrate may use a polymeric elastomer such as a polyolefin, examples of which include, but are not limited to, polyisobutylene, polyisoprene, polybutene, and polybutadiene, and copolymers including at least one olefin polymer block. For example poly(styrene/olefin/styrene) block copolymers such as poly(styrene/isobutylene/styrene), poly(styrene/butylene/styrene), poly(styrene/butadiene/benzene) Ethylene), poly(styrene/isoprene/styrene), poly(styrene/ethylene/butylene/styrene), and the like. The above polymers may be used singly or in the form of a mixture of plural kinds. In some embodiments, one or more of polybutadiene, polyisoprene, and polyisobutylene are used. In some embodiments, one or more of butadiene rubber, polyisoprene, and polyisobutylene are used.

A commercially available product may be used as the binder substrate, examples of which include, but are not limited to, one or more selected from the group consisting of Sinopec Qilu Petrochemical Company's BR9000 polybutadiene (butadiene rubber), Natsyn 2210 polyisoprene obtained from Goodyear, USA, and SDG-8650 polyisobutylene obtained from Hangzhou Shunda Plastic Co., Ltd. (China) LM-MH from ExxonMobil (USA), PIB 6H polyisobutylene from RitChem (USA), Polyisobutylene Oppanol B10-B15 from BASF (Germany), Glissopal 1000, Glissopal 1300, and Glissopal 2300 .

Viscosity can be adjusted by using polymers of different molecular weights. The lower the molecular weight of the polymer used, the greater the viscosity provided. The molecular weight of the polymer used as the binder substrate is generally in the range of Mn = 1,000 to 1,000,000, preferably in the range of Mn = 5,000 to 90,000, more preferably in the range of Mn = 10,000 to 80,000. A mixture of two or more polymers having different molecular weights can be used as the binder substrate to obtain the desired viscosity.

In some embodiments, the polymer as the binder base has a glass transition temperature (Tg) of -200 to 300 ° C, preferably -190 to 250 ° C, more preferably -180 to 200 ° C.

In some embodiments, the Mooney viscosity (ML-4' at 100 ° C) of the polymer as the binder substrate is from 10 to 100, preferably from 30 to 70.

In some embodiments, the Staudinger index (intrinsic viscosity) of the polymer as the binder base is from 20 to 60 ml/g, preferably from 30 to 50 ml/g.

The content of the binder substrate in the hydrocolloid layer is from 10 to 90% by weight, preferably from 20 to 85% by weight, more preferably from 30 to 80% by weight, even more preferably based on 100% by weight of the hydrocolloid layer. 40-80% by weight, still more preferably 50-80% by weight, still more preferably 60-80% by weight.

The material used to form the hydrocolloid layer also optionally includes tackifying Resin to further adjust the viscosity of the product.

The content of the tackifying resin in the hydrocolloid layer is from 0 to 50% by weight, preferably from 5 to 40% by weight, more preferably from 5 to 30% by weight, based on the total weight of the hydrocolloid layer.

The tackifying resin may be one or more selected from the group consisting of petroleum resins such as aliphatic, alicyclic and aromatic copolymers; terpene resins; terpene-styrene resins; coumarone-decene Resin-like resin; rosin-based resin; hydrogenated product of the above resin. The tackifying resin preferably used is selected from the group consisting of aliphatic and alicyclic petroleum resins; terpene resins and terpene-styrene resins. The most preferred tackifying resin used is selected from the group consisting of aliphatic and cycloaliphatic petroleum resins.

Examples of commercially available products that can be used as tackifying resins include, but are not limited to, one or more selected from the group consisting of Eastotac H-100R Resin from Eastman Chemical Company (USA), obtained from Cray Willyack 95 of Willie (France), Escorez 5340 from ExxonMobil (USA), and Sylvalite RE80HP Rosin Ester from Arizona Chemicals (USA).

The polymer which can be used to form the polymer film layer in the hydrocolloid dressing can be any material commonly used in the art, particularly a polymer having film forming properties which can be dissolved in a volatile solvent or water, and specific examples thereof include However, it is not limited to one or more of polyurethane, polyolefin such as polyethylene or polypropylene, polyester, polyamide, acrylic polymer, olefin copolymer such as ethylene-vinyl acetate copolymer. Among them, preferred are polyurethane, polyester, polyethylene or ethylene-vinyl acetate copolymer, more preferably polyurethane or ethylene-vinyl acetate copolymer. Better use of biocompatibility and prevention A water-soluble polymer such as polyurethane. The term "acrylic polymer" refers to both acrylic and acrylate polymers, including methacrylic and methacrylate polymers.

The molecular weight, glass transition temperature (Tg), and the like of the polymer are not particularly limited. However, the polymer has a weight average molecular weight of from 2,000 to 1,000,000, preferably from 2,000 to 900,000, more preferably from 2,000 to 800,000, most preferably from 2,000 to 700,000, from the viewpoint of facilitating in-situ coating. In order to obtain a better bond with the hydrocolloid layer, it is avoided to use some polymers with lower surface energy, such as anthrone. More preferably, a polymer having a surface energy similar to that of the hydrocolloid layer is used, and examples thereof include, but are not limited to, polyurethane, polyolefin such as polyethylene or polypropylene, polyester, and the like.

In one embodiment, a polyurethane (PU) layer is used as the polymeric film layer. Examples of the polyurethane which can be used include, but are not limited to, an aliphatic polyether polyurethane, an aliphatic polyester polyurethane, an aromatic polyether polyurethane, an aromatic polyester polyurethane; preferably an aromatic polyether polyurethane. Examples thereof include, but are not limited to, di(or poly)cyanate polyether polyurethane, di(or poly)cyanate polyester polyurethane, and the like, wherein "di(or poly) cyanate" and "di or polycyanate" "Ester" is used interchangeably and refers to dicyanate or polycyanate, which may be selected from hexamethylene diisocyanate, naphthalene diisocyanate, toluene diisocyanate (TDI), diphenylmethane diisocyanate (MDI). Hydrogenated toluene diisocyanate, hydrogenated diphenylmethane diisocyanate, isophorone diisocyanate, and the like. More preferably, a polyurethane having a swelling property close to that of the hydrocolloid layer material is used.

In order to facilitate in-situ coating and form a suitable thickness of poly The polymer film or the liquid polymer used in the present invention has a viscosity of 100 cps or more, 500 cps or more, 1000 cps or more, 3000 cps or more, 6000 cps or more, or 10000 cps or more, and 150,000 cps or less, 130,000 cps or less, and 110000 cps or less. Below 90000 cps, below 70000 cps, or below 50000 cps. From the viewpoint of more favorable coating and obtaining a hydrocolloid dressing having better bonding strength between the two layers, for example, the viscosity of the polymer solution or the liquid polymer used may be 100 to 150,000 cps, preferably 500 to 130000 cps, more preferably 1000. -110000 cps, more preferably 3000-90000 cps, still more preferably 6000-70000 cps, and most preferably 10000-50000 cps. Depending on the viscosity range, different coating methods can be used. For example, lower viscosity can be applied by curtain coating or anilox coating. For high viscosity, comma roller coating, blade coating, extrusion coating, etc. can be used. In the same way, the same coating effect can be achieved. The solution viscosity can be measured by a Brookfield Type VII viscometer. The above viscosity is a Brookfield viscosity at 25 °C.

The concentration (solid content) of the polymer solution may be 5% or more, 10% or more, 15% or more, 20% or more, or 25% or more, and 90% or less, 80% or less, 70% or less, 60% by weight. % or less, 50% or less, or 40% or less, for example, 5-90%, 10-80%, 15-70%, or 20-50%.

The solvent used to form the polymer solution is not particularly limited and may be one or more selected from the group consisting of water, alcohols, esters, aliphatic hydrocarbons, aromatic hydrocarbons, ketones, and decylamines, and may be, for example, one of the solvents listed below. Or a plurality of: isopropanol, ethyl acetate, heptane, toluene, xylene, water, dimethylformamide (DMF), methyl ethyl ketone, and the like.

A commercially available polymer solution can be used to form the polymer film layer. Examples of commercially available polymer solutions include V-Coat AB5454LV, V-Coat AB5858LV and V-Coat 775, which are obtained from China Jiaxing Puyou Chemical Co., Ltd., which are respectively diphenylmethane diisocyanate (MDI) polyether type. The viscosity of polyurethane in DMF/butanone and DMF/butanone/toluene is slightly different.

The thickness of the hydrocolloid layer and the polymer film layer in the hydrocolloid dressing can be selected according to actual needs. The thickness of the hydrocolloid layer will primarily affect the water absorption and comfort of the dressing, while the thickness of the polymeric film layer will affect the breathability and comfort of the dressing. Wherein, the hydrocolloid layer has a thickness of 10-5000 micrometers, preferably 15-4500 micrometers, more preferably 20-4000 micrometers, and most preferably 25-3500 micrometers. The thickness of the polymeric film layer is from 4 to 200 microns, preferably from 4 to 180 microns, more preferably from 4 to 160 microns, and most preferably from 4 to 140 microns.

In some embodiments, the hydrocolloid dressing further includes a protective layer. For example, release paper. The protective layer is in contact with the outer surface of the hydrocolloid layer, that is, on the surface opposite to the surface in contact with the hydrocolloid layer and the polymer film layer, and functions to protect the hydrocolloid layer. At the time of use, the protective layer is peeled off, and the hydrocolloid layer is attached to the portion where the dressing is to be used. The release paper can be of any type conventionally used in the art. Materials which can be used as release paper include, but are not limited to, cellophane, laminated paper, polyester film, polypropylene film, etc., and they are preferably coated with a resin.

The invention also provides a method for preparing a hydrocolloid dressing comprising: forming a hydrocolloid layer; A polymer solution or a liquid polymer is coated on the hydrocolloid layer; and dried.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a schematic illustration of a method of preparing a hydrocolloid dressing in accordance with one embodiment of the present invention, the specific steps being as follows.

Forming a hydrocolloid layer by extrusion, extrusion or coating. For example, various materials forming a hydrocolloid layer are kneaded by a kneader to form a mass, which is then extruded by a extruder or a tablet press with a certain die or The sheet is extruded, and it can also be directly extruded by an extruder to obtain a hydrocolloid layer. Subsequently, the polymer solution was coated on the hydrocolloid layer, and the solvent was removed by an oven to be dried. The product can be selectively wound up.

In some embodiments, the conditions known in the art can be used by forming a hydrocolloid layer by extrusion. For example, in some embodiments, the extrusion temperature is 80-120 °C.

The method of coating the polymer solution or the liquid polymer is not particularly limited, and may be any of comma roll coating, anilox roll coating, impregnation coating, blade coating, extrusion coating, and the like.

The drying step in the preparation method of the hydrocolloid dressing can be carried out at 30 to 300 ° C, preferably 35 to 270 ° C, more preferably 40 to 250 ° C. In some embodiments, the drying step is carried out at 40-200 °C. Different temperature gradients can be set as needed to achieve better drying results.

In order to further improve the integrity of the hydrocolloid itself, it is also possible to carry out crosslinking after drying so that the unsaturated chains in the polymer in the hydrocolloid formulation are crosslinked to bond with each other. The crosslinking method is not particularly limited, and Crosslinking may also be carried out by adding a crosslinking agent to the formulation by using gamma irradiation, UV irradiation, electron beam irradiation or the like. Examples of crosslinking agents that can be used include, but are not limited to, dicumyl peroxide (DCP), benzammonium peroxide (BPO), di-tert-butyl peroxide (DTBP), and the like.

In one embodiment, the sample is cross-linked using gamma rays and the gamma dose is set to 5-100 kGy.

The hydrocolloid dressing of the present invention is coated with a polymer solution or a liquid polymer in situ on a hydrocolloid layer as compared to a conventional method of pre-extruding a polymer film and then compounding it while extruding the hydrocolloid layer. It is obtained by forming a polymer film layer, and the binding force between the hydrocolloid layer and the polymer film layer thus obtained is stronger. According to some embodiments of the present invention, since the bonding force between the hydrocolloid layer and the polymer film layer is very high, the two layers cannot be completely peeled off, and when the two layers are peeled off, the area and total of the peeled portion are The area ratio is less than 100%. According to some embodiments of the present invention, the bonding force between the hydrocolloid layer and the polymer film layer is relatively high, it is possible to completely peel the two layers apart, and the peeling force of the two layers completely peeled off is greater than 60 oz/0.5. In, when the two layers are completely peeled off, the ratio of the area of the peeled portion to the total area is equal to 100%.

In some embodiments, the hydrocolloid dressing is subjected to a peel test to measure the ratio of the area of the stripped portion to the total area and the peel force between the two layers, which can be measured using a tensile machine. For example, it can be carried out as follows: the polymer layer of the hydrocolloid dressing is fixed on the panel of the tensile machine, for example by double-sided adhesive or adhesive, and the hydrocolloid layer is adhered with test tape to test the width of the tape. At least the same width as the hydrocolloid dressing, and at least The remaining part is left at one end. When testing, the remaining part of the test tape is folded back 180 degrees, fixed on the clamp of the tensile machine, the tensile machine is started to test the peeling force, and the area of the stripped portion is observed. The bonding force between the double-sided tape or adhesive used to fix the polymer layer and the polymer layer should be at a certain level, at least greater than the peeling force between the hydrocolloid layer and the polymer layer, for example, using a bonding force greater than 55 oz/0.5 in. Double-sided adhesive or adhesive, preferably double-sided adhesive or adhesive with a bonding strength greater than 75oz/0.5in, better double-sided adhesive or adhesive with a bonding strength greater than 95oz/0.5in, and better bonding strength greater than 115oz/0.5 In the double-sided adhesive or adhesive, it is better to have a double-sided adhesive or adhesive with a bonding strength greater than 135 oz/0.5 in. It is also better to have a double-sided adhesive or adhesive with a bonding force greater than 155 oz/0.5 in. The bonding force between the test tape and the hydrocolloid layer used should reach a certain level, at least greater than the peeling force between the hydrocolloid layer and the polymer layer. For example, using a test tape having a bonding force greater than 55 oz/0.5 in., the preferred bonding force is greater than 75oz/0.5in test tape, better test adhesion than 95oz/0.5in test tape, better test tape with a bond strength greater than 115oz/0.5in, and better test tape with a bond strength greater than 135oz/0.5in. Better test adhesions greater than 155 oz / 0.5 in. In some embodiments, a tape numbered 2525 from 3M U.S. Company was used as the test tape, and a double-sided tape numbered 4951 from 3M U.S. Company was used as the double-sided tape of the fixed polymer layer.

In some embodiments, the respective fracture strengths of the hydrocolloid layer and the polymeric film layer are measured and compared to the peel force of the two layers. The breaking strength can be tested by methods commonly used in the art, such as with a tensile machine. In some embodiments, the two ends of the strip-shaped test sample are respectively fixed on the clamp of the tensile machine, and the tensile machine is driven to stretch the spline until the fracture is broken, and the fracture is recorded. The moment of force is the breaking strength.

The invention is described in more detail below by way of examples, but should not be construed as limiting the scope of the invention in any way.

Example

The material series used in the examples are shown in Table 1. The instrument series used in the examples are shown in Table 2.

Example 1

Based on the total weight of the raw materials used, 35% was purchased from Qilu Petrochemical BR9000 butadiene rubber, 45% PIB 6H polyisobutylene from RitChem, 20% HS 100000 YP2 hydroxyethyl cellulose purchased from Clariant Chemical, placed in a vacuum kneader for 1-2 hours, then Vacuuming (vacuum degree 0.07 MPa) was kneaded for 1 hour.

The above mixture was placed in a rubber extruder and extruded into a hydrocolloid sheet having an average thickness of 0.5 mm. The extrusion temperature is 80-120 °C.

A V-Coat AB5454LV type polyurethane solution (solid content: 30%, viscosity: 12,000-18,000 cps/25 ° C) purchased from Jiaxing Puyou was applied to the above hydrocolloid extruded sheet by a solvent coater using a comma roller The gap is set to 83 microns. The solvent was dried in an oven and the oven temperature was set to a temperature gradient of 40-200 °C. After drying, a polyurethane film having an average thickness of 25 μm was formed on the hydrocolloid layer.

The sample was crosslinked with gamma rays and the gamma dose was set at 20-60 kGy.

Example 2

50% of the total weight of the raw materials used, 50% of Natsyn 2210 polyisoprene from Goodyear, 20% of SDG-8650 polyisobutylene from Hangzhou Shunda and 30% of FH5000 carboxymethyl purchased from Suzhou Weiyi The sodium cellulose base was kneaded in a vacuum kneader for 1-2 hours, and then vacuumed (vacuum degree: 0.05 MPa) for 1 hour.

The above mixture was placed in a rubber extruder and extruded into a hydrocolloid sheet having an average thickness of 1 mm. The extrusion temperature is 80-120 °C.

V-Coat AB5858LV type polyurethane solution purchased from Jiaxing Puyou using a solvent-based coater (solid content: 30%, viscosity: 25,000-40,000 cps/25 ° C) was applied to the above hydrocolloid extruded sheet. The solvent was dried in an oven and the oven temperature was set to a temperature gradient of 40-200 °C. After drying, a polyurethane film having an average thickness of 30 μm was formed on the hydrocolloid layer. The sample was crosslinked with gamma rays and the gamma dose was set to 10-50 kGy.

Example 3

A hydrocolloid sheet having an average thickness of 1 mm was prepared in the same formulation and operating conditions as in Example 2.

A V-Coat 775 type polyurethane solution (solid content: 30%, viscosity: 85,000-110,000 cps/25 ° C) purchased from Jiaxing Puyou was applied to the above hydrocolloid extruded sheet by a solvent type coater. The solvent was dried in an oven and the oven temperature was set to a temperature gradient of 40-200 °C. After drying, a polyurethane film having an average thickness of 30 μm was formed on the hydrocolloid layer. The sample was crosslinked with gamma rays and the gamma dose was set to 10-50 kGy.

Comparative example 1

The hydrocolloid dressing is prepared by combining a hydrocolloid with a pre-prepared film.

First, the V-Coat AB5454LV type polyurethane solution purchased from Jiaxing Puyou used in Example 1 was applied to the release material under the operating conditions of Example 1 using a solvent type coater to finally obtain an average thickness of 25 Micron polyurethane film. An appropriate amount of this polyurethane film of 1 inch width was placed in a tensile machine jig having a clamping distance of 100 mm, and the sample was stretched at a speed of 100 mm/min to break. The maximum tensile strength is recorded, which is its breaking strength (F1-1).

Extrusion of a 0.5 mm hydrocolloid tablet by the method of Example 1. A suitable amount of this hydrocolloid sheet having a width of 1 in. was measured for the breaking strength (F1-2) by the above method.

The above hydrocolloid sheet was continuously extruded, and at the same time, the above polyurethane film was laminated on the hydrocolloid sheet. Winding.

The sample was crosslinked with gamma rays and the gamma dose was set to 10-50 kGy.

Comparative example 2

The hydrocolloid dressing is prepared by combining a hydrocolloid with a pre-prepared film.

First, the V-Coat AB5858LV type polyurethane solution purchased from Jiaxing Puyou used in Example 2 was applied to the release material under the operating conditions of Example 2 using a solvent type coater to finally obtain an average thickness of 30. Micron polyurethane film. An appropriate amount of this polyurethane film of 1 inch width was placed in a tensile machine jig having a clamping distance of 100 mm, and the sample was stretched at a speed of 100 mm/min to break. Record the maximum tensile strength, which is its breaking strength (F2-1).

Using the method of Example 2, a 1 mm hydrocolloid sheet was extruded, and an appropriate amount of this hydrocolloid sheet of 1 inch width was taken, and the breaking strength (F2-2) was measured by the above method.

The above hydrocolloid sheet was continuously extruded, and at the same time, the above polyurethane film was laminated on the hydrocolloid sheet. Winding.

The sample was crosslinked with gamma rays and the gamma dose was set at 20-60 kGy.

Bond test A. Peel test

The bonding force between the hydrocolloid layer of the samples of Examples 1-3 and Comparative Examples 1-2 and the polyurethane film was tested by the following method.

1) Fix the polyurethane film side of the sample to be tested on the panel of the IMASS tensile machine with the double-sided tape No. 4951 obtained from 3M American Company, with the hydrocolloid face up; 2) then the number obtained from 3M US company The tape of 2525 is attached to the surface of the water gel, and is rolled back and forth with a 2kg roller. The 2525 tape is the same as the width of the hydrocolloid dressing to be tested, but the remaining portions are left at both ends; 3) the end of the 2525 tape is folded back. 180 degrees, clamped with a clamp; 4) start the IMASS tensile machine to start peeling, record the peeling force and observe the transfer of the rubber surface, calculate the area and total of the stripped part by the transferred water colloid layer as a percentage of the area of the hydrocolloid dressing Area ratio.

Each sample was tested 3 times and the test results are shown in Table 3. F1-1, F1-2, F2-1 and F2-2 are also listed in Table 3. The breaking strength and peeling force results are the average of three measurements.

As can be seen from the results in Table 3, at the time of peeling, the hydrocolloid layers in Examples 1 and 2 were destroyed and only 25-50% were transferred, and the hydrocolloid layer in Example 3 was destroyed and 75-100% was Transfer, while the hydrocolloid layers in Comparative Examples 1 and 2 remained intact and were 100% transferred. Also, in Examples 1, 2 and 3, the force of peeling off the two layers in the case where the hydrocolloid layer was broken was measured, which was greater than the respective breaking strength of the hydrocolloid layer and/or the polymer film layer, and Comparative Examples 1 and 2 The peeling force of the hydrocolloid layer and the polymer film layer measured in the middle was much smaller than the peeling force measured in Examples 1-3 and less than the breaking strength of the polymer film layer.

It can be seen that the hydrocolloid/film combination prepared by the method of the present invention has a higher binding force.

B. Soak test

The adhesion between the hydrocolloid and the polymer film in the samples of the examples and the comparative examples was further evaluated by the immersion test.

The test was carried out using a wide-mouth glass bottle with a cap diameter of 1.5 inches.

1) The hydrocolloid dressings prepared in Examples 1, 2, and 3 and Comparative Example 1 were cross-linked and cut into a shape conforming to the mouth of the bottle, and placed in the order of a cap, a hydrocolloid dressing, and a rubber gasket to obtain a sample.

2) Configure the analog wound exudate as follows (YY/T 0471.1-2004): 8.298 g of sodium chloride and 0.3689 g of calcium chloride dihydrate were dissolved in deionized water in a volumetric flask and diluted to 1 L. The simulated wound exudate consisted of a solution containing sodium chloride and calcium chloride containing 142 mmol of sodium ions and 2.5 mmol of calcium ions. The ion content of the solution corresponds to human serum or wound exudate.

3) Place the sample prepared in 1) on the bottle containing the simulated wound exudate in 2) and screw the cap.

4) Invert the bottle so that the hydrocolloid dressing was soaked in the simulated wound exudate and allowed to stand in an oven at 37 ° C for 24 hours.

5) Take out the sample after 24 hours (Fig. 3(a) and Fig. 3(b)).

Fig. 3(a) shows the surface of the polyurethane film, and Fig. 3(b) shows the surface of the hydrocolloid. As can be seen from the figure, the sample of Comparative Example 1 (a1, b1) showed a distinct "bubble". The hydrocolloid dressings of Examples 1 (a2, b2), Example 2 (a3, b3) and Example 3 (a4, b4) swelled, but no "bubbles" were produced, indicating the hydrocolloids in the examples. The film combination still had good adhesion after contact with the wound for 24 hours, and no separation occurred.

C. Scanning electron microscopy

The cross sections of the dressings of Example 1 and Comparative Example 1 were observed by scanning electron microscopy.

Figure 4 (a) is a sample of Example 1, wherein 1 is a polymer film and 2 is a hydrocolloid layer, and it can be clearly seen that the hydrocolloid and the polymer film are tightly bonded together, which proves hydrocolloid and polymerization. The reason why the film adhesion is higher.

Figure 4 (b) is a sample of Comparative Example 1, in which 1 is a polymer film and 2 is a hydrocolloid layer, and the boundary between the hydrocolloid and the polymer film is very conspicuous.

Claims (33)

A hydrocolloid dressing comprising: a hydrocolloid layer; and a polymer film layer disposed on the hydrocolloid layer; wherein the polymer film layer is formed by coating a polymer solution or a liquid polymer, And when the hydrocolloid layer and the polymer film layer are peeled off from each other, the ratio of the area of the peeled portion to the total area is less than 100%. A hydrocolloid dressing comprising: a hydrocolloid layer; and a polymer film layer disposed on the hydrocolloid layer; wherein the polymer film layer is formed by coating a polymer solution or a liquid polymer, And when the hydrocolloid layer and the polymer film layer are peeled off from each other, the ratio of the area of the peeled portion to the total area is equal to 100%, and the peeling force of the two layers is more than 60 oz / 0.5 in. A hydrocolloid dressing comprising: a hydrocolloid layer; and a polymer film layer disposed on the hydrocolloid layer; wherein the polymer film layer is formed by coating a polymer solution or a liquid polymer, And the peeling force of the water colloid layer and the polymer film layer being separated from each other is greater than the breaking strength of the hydrocolloid layer or the polymer film layer. The hydrocolloid dressing according to any one of claims 1 to 3, wherein the hydrocolloid layer is based on 100% by weight of the hydrocolloid layer It comprises: 5 to 55% by weight of a gelling agent, 10 to 90% by weight of a binder substrate, and 0 to 50% by weight of a tackifying resin. The hydrocolloid dressing according to claim 4, wherein the gelling agent is selected from the group consisting of: a natural hydrophilic polymer compound, a semi-synthetic hydrophilic polymer compound, and a synthetic hydrophilic polymer compound. The group formed. The hydrocolloid dressing according to claim 5, wherein the natural hydrophilic polymer compound is selected from the group consisting of: a polysaccharide polymer, a protein polymer, and a polypeptide polymer. group. The hydrocolloid dressing according to claim 6, wherein the polysaccharide polymer is selected from the group consisting of: a pectin, a gum arabic, a guar gum, an agar, a starch, a xanthan gum and a grape. A group consisting of glycans. The hydrocolloid dressing according to claim 6, wherein the protein polymer or the polypeptide polymer is selected from the group consisting of: a gelatin, an albumin and a casein. The hydrocolloid dressing according to claim 5, wherein the semi-synthetic hydrophilic polymer compound is selected from the group consisting of carboxymethylcellulose, sodium carboxymethylcellulose, methylcellulose, and ethylcellulose. a group consisting of hydroxyethyl cellulose, hydroxypropyl cellulose, methyl hydroxypropyl cellulose, sodium alginate, and carboxymethyl starch. The hydrocolloid dressing according to claim 5, wherein the synthetic hydrophilic polymer compound is selected from the group consisting of acrylic polymers, polyvinyl alcohol, polyvinyl pyrrolidone, polyethylene glycol, and polyethylene. A group consisting of ethers. The hydrocolloid dressing of claim 10, wherein the acrylic polymer is polyacrylic acid or polypropylene decylamine. The hydrocolloid dressing of claim 4, wherein the binder substrate is one or more selected from the group consisting of polymeric elastomers. The hydrocolloid dressing of claim 12, wherein the polymer elastomer is a polyolefin or a copolymer comprising at least one olefin polymer block. The hydrocolloid dressing of claim 13, wherein the polyolefin is selected from the group consisting of polyisobutylene, polyisoprene, polybutene, and polybutadiene. The hydrocolloid dressing according to claim 4, wherein the tackifying resin is selected from the group consisting of aliphatic petroleum resins, alicyclic petroleum resins, and aromatic copolymer petroleum systems. A resin, a terpene resin, a terpene-styrene resin, a coumarone-decene resin, a rosin-based resin, and a hydrogenated product of the above resin. The hydrocolloid dressing according to any one of claims 1 to 3, wherein the polymer film layer is formed of one or more selected from the group consisting of polyurethane, polyolefin , polyester, polyamide, acrylic or acrylate polymers, and olefin copolymers. The hydrocolloid dressing of claim 16, wherein the polymer film layer is formed from one or more selected from the group consisting of polyurethane, polyethylene, polypropylene, polyester. And an ethylene-vinyl acetate copolymer. The hydrocolloid dressing according to claim 16, wherein the polyurethane is selected from the group consisting of aliphatic polyether polyurethane, aliphatic polyester polyurethane, aromatic polyether polyurethane and aromatic polyester polyurethane. Group. The hydrocolloid dressing according to claim 16, wherein the polyurethane is selected from the group consisting of: dicyanate polyether polyurethane, polycyanate polyether polyurethane, dicyanate polyester polyurethane and polycyanic acid. A group consisting of ester polyester polyurethanes. The hydrocolloid dressing according to claim 19, wherein the dicyanate or polycyanate is selected from the group consisting of: hexamethylene diisocyanate, naphthalene diisocyanate, toluene diisocyanate, diphenylmethane diisocyanate, A group consisting of hydrogenated toluene diisocyanate, hydrogenated diphenylmethane diisocyanate, and isophorone diisocyanate. The hydrocolloid dressing of claim 16, wherein the polymer forming the polymer film layer has a weight average molecular weight of 2,000 to 1,000,000. The hydrocolloid dressing according to any one of claims 1 to 3, wherein the hydrocolloid layer has a thickness of 10 to 5000 μm. The hydrocolloid dressing according to any one of claims 1 to 3, wherein the polymer film layer has a thickness of 4 to 200 μm. The hydrocolloid dressing according to any one of claims 1 to 3, further comprising: a protective layer. A method of preparing a hydrocolloid dressing according to any one of claims 1 to 24, comprising: Forming a hydrocolloid layer; coating a polymer solution or a liquid polymer onto the hydrocolloid layer; and drying. The method of claim 25, wherein the hydrocolloid layer is formed by an extrusion, hot pressing or coating process. The method of claim 25, wherein the hydrocolloid layer comprises: 5 to 55% by weight of a gelling agent, and 10 to 90% by weight of a binder based on 100% by weight of the hydrocolloid layer. a base of the agent, and 0-50% by weight of a tackifying resin. The method of claim 25 or 26, wherein the polymer solution is selected from the group consisting of polyurethane, polyolefin, polyester, polyamine, acrylic polymer, acrylate polymer, and olefin copolymer. One or more of the group consisting of a solution in a solvent selected from the group consisting of water, alcohols, esters, aliphatic hydrocarbons, aromatic hydrocarbons, ketones, and decylamines, the liquid polymerization The system is selected from the group consisting of polyurethane, polyolefin, polyester, polyamide, acrylic polymer, acrylate polymer, and olefin copolymer. The method of claim 27, wherein the polymer solution is one or more selected from the group consisting of polyurethane, polyethylene, polypropylene, polyester, and ethylene-vinyl acetate copolymer. a solution in a solvent selected from the group consisting of water, alcohols, esters, aliphatic hydrocarbons, aromatic hydrocarbons, ketones, and decylamines selected from the group consisting of: poly A group consisting of urethane, polyethylene, polypropylene, polyester, and ethylene-vinyl acetate copolymer. The method of claim 25 or 26, wherein the polymer solution or the liquid polymer has a Brookfield viscosity of from 100 to 150,000 cps at 25 °C. The method of claim 25, wherein the drying temperature is 30-300 °C. The method of claim 25 or 26, further comprising: crosslinking after drying. The method of claim 32, wherein the crosslinking is performed using one or more of gamma irradiation, UV irradiation, electron beam irradiation, or addition of a crosslinking agent.