Hydrocolloid dressing as well as preparation method and application thereof

Abstract

The invention discloses a hydrocolloid dressing. The hydrocolloid dressing comprises (1) a polyurethane film layer; a hydrocolloid matrix comprises a medical hot melt adhesive, sodium carboxymethyl cellulose and amino acid gel, and the mass ratio of the medical hot melt adhesive to the sodium carboxymethyl cellulose to the amino acid gel is (55-80): (20-45): (0.25-5); and (3) a release paper layer. According to the hydrocolloid dressing and the preparation method and application thereof, a moist healing environment can be provided for a wound surface, wound seepage can be effectively absorbed, wound infection can be prevented, a chiral space microenvironment suitable for cell crawling and migration can be created, granulation formation and capillary and epidermal cell regeneration are facilitated, wound healing is accelerated, and the wound healing effect is improved. Scar hyperplasia is prevented and reduced.

Description

Technical Field

[0001] The present invention relates to the field of medical technology, and in particular to a hydrocolloid dressing and a preparation method and application thereof. Background Art

[0002] Wound dressings can cover and protect wounds and promote wound healing in trauma, burns, diabetic foot and postoperative incisions. An ideal wound dressing can provide a moist environment, prevent secondary infection, remove excess tissue exudate, promote tissue regeneration near the wound, improve wound healing quality and reduce scar formation. Hydrocolloid dressings are generally made of elastic polymerized hydrogels mixed with synthetic rubber and adhesives, and have the ability to absorb wound exudate. After absorbing the exudate, the hydrophilic particles in the dressing can form a semi-solid substance similar to gel, which adheres to the base of the wound, providing and maintaining a moist environment that is conducive to wound healing. As a new type of dressing, hydrocolloid dressings are increasingly used in clinical applications, such as for superficial burns, partial-thickness burns, donor site wounds, postoperative wounds, skin abrasions and ulcers. The good ability of hydrocolloid dressings to absorb exudate has certain advantages in wound healing, but it still has certain limitations in the face of complex wound repair, especially in promoting microvascular proliferation and accelerating wound healing. Summary of the invention

[0003] Based on this, the present invention provides a hydrocolloid dressing, which comprises

[0004] (1) Polyurethane film layer;

[0005] (2) a hydrocolloid matrix layer, wherein the hydrocolloid matrix comprises medical hot melt adhesive, sodium carboxymethyl cellulose and amino acid gel, and the mass ratio of the medical hot melt adhesive, the sodium carboxymethyl cellulose and the amino acid gel is (55-80):(20-45):(0.25-5); and

[0006] (3) Release paper layer.

[0007] Furthermore, the medical hot melt adhesive is selected from one or more of the following: polyisoprene, polyisobutylene, styrene-isoprene-styrene block copolymer and hydrogenated petroleum resin.

[0008] Furthermore, the medical hot melt adhesive is a styrene-isoprene-styrene block copolymer.

[0009] Furthermore, the viscosity of the sodium carboxymethyl cellulose is 800 mpa·s to 1200 mpa·s.

[0010] Furthermore, the amino acid gel is a chiral amino acid gel.

[0011] Furthermore, the chiral amino acid gel is a chiral phenylalanine-based gel.

[0012] Further, the chiral phenylalanine-based gel has the structure of the following formula I:

[0013]

[0014] Furthermore, the mass ratio of the medical hot melt adhesive, the sodium carboxymethyl cellulose and the amino acid gel is (55-75):(20-35):(0.5-5).

[0015] Furthermore, the mass ratio of the medical hot melt adhesive, the sodium carboxymethyl cellulose and the amino acid gel is (65-75):(25-35):(0.5-1.25).

[0016] Furthermore, the mass ratio of the medical hot melt adhesive, the sodium carboxymethyl cellulose and the amino acid gel is about 70: about 30: about 1.

[0017] Furthermore, the hydrocolloid dressing is a thin hydrocolloid dressing or a common hydrocolloid dressing.

[0018] Furthermore, the hydrocolloid dressing is an adhesive-edge type hydrocolloid dressing or a non-adhesive-edge type hydrocolloid dressing.

[0019] According to another aspect of the present invention, there is provided a method for preparing the above-mentioned hydrocolloid dressing, the method comprising the following steps:

[0020] (1) Weigh an appropriate amount of medical hot melt adhesive and melt the adhesive at a certain temperature;

[0021] (2) Weighing an appropriate amount of sodium carboxymethyl cellulose and an appropriate amount of amino acid gel, slowly adding them to the medical hot melt adhesive after the sol, and stirring at a certain temperature;

[0022] (3) mixing the medical hot melt adhesive, the sodium carboxymethyl cellulose and the amino acid gel until the colloid is uniform, vacuuming and degassing, and discharging the mixture to obtain a hydrocolloid matrix material; and

[0023] (4) The hydrocolloid matrix material is transferred to a hopper of a coating machine for coating and cutting to obtain the hydrocolloid dressing.

[0024] Furthermore, in step (1), the temperature of the molten adhesive is 140°C to 160°C.

[0025] Furthermore, in step (1), the temperature of the molten adhesive is about 150°C.

[0026] Furthermore, in step (1), the melting time is 0.5 to 3 hours.

[0027] Furthermore, in step (1), the melting time is about 1 hour.

[0028] Furthermore, in step (2), the stirring temperature is 125°C to 135°C.

[0029] Furthermore, in step (2), the stirring temperature is about 130°C.

[0030] Furthermore, in step (2), the stirring time is 1 to 5 hours.

[0031] Furthermore, in step (2), the stirring time is about 3 hours.

[0032] Furthermore, in step (2), the stirring results in a paste-like semi-fluid state with no powder particles visible to the naked eye.

[0033] Furthermore, in step (3), the vacuum degassing time is 8 min to 12 min.

[0034] Furthermore, in step (3), the vacuum degassing time is about 10 minutes.

[0035] Furthermore, in step (4), before the coating, a polyurethane film layer and a release paper layer are pre-placed in the coating machine.

[0036] Furthermore, in step (4), the hydrocolloid dressing is a sheet-shaped hydrocolloid dressing.

[0037] According to another aspect of the present invention, there is provided a use of the above-mentioned hydrocolloid dressing in preparing a material for covering and / or protecting a wound.

[0038] Furthermore, the wound is a wound caused by trauma, burn, diabetic foot and / or postoperative incision.

[0039] Further, the trauma is a donor site wound, a skin abrasion and / or an ulcer.

[0040] Further, the burn is a superficial skin burn and / or a partial thickness burn.

[0041] Beneficial effects of the present invention:

[0042] The present invention provides a hydrocolloid dressing and a preparation method and use thereof, which can not only provide a moist healing environment for the wound surface, effectively absorb wound exudate and prevent wound infection, but also create a chiral spatial microenvironment suitable for cell crawling and migration, which is beneficial to granulation formation, microvessel and epidermal cell regeneration, accelerate wound healing, and prevent and reduce scar hyperplasia. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings required for use in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without exceeding the scope of protection required by the present invention.

[0044] Figure 1 It is a schematic structural diagram of the hydrocolloid dressing of the present invention.

[0045] Figure 2 The figure is a schematic diagram for comparing the wound healing effects of the hydrocolloid dressing of the present invention. DETAILED DESCRIPTION

[0046] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative work are within the scope of protection of the present invention.

[0047] Unless otherwise indicated, all technical and scientific terms and abbreviations used herein have the meanings commonly understood by those of ordinary skill in the field of the invention or the field in which the terms are used. Although any methods, conditions, substances or materials similar to or equivalent to those disclosed herein may be used in the practice of the present invention, preferred methods, conditions, substances or materials are described herein.

[0048] The present invention is intended to encompass all alternatives, variations and equivalents that may be included in the present invention as defined by the claims. Those skilled in the art will recognize many methods and materials similar or equivalent to those described herein that can be used in the practice of the present invention. The present invention is in no way limited to the methods and materials described.

[0049] To the extent that the terms "comprises," "including," and "having," "has," and "with," or variations thereof, are used in the detailed description and / or claims, these terms are intended to be inclusive in a manner similar to the term "comprising."

[0050] As described in the background technology section, existing hydrocolloid dressings still have great deficiencies in promoting microvascular proliferation and accelerating wound healing. In order to solve the above problems, the present invention provides a hydrocolloid dressing (such as Figure 1 As shown), the hydrocolloid dressing comprises

[0051] (1) Polyurethane film layer;

[0052] (2) a hydrocolloid matrix layer, wherein the hydrocolloid matrix comprises medical hot melt adhesive, sodium carboxymethyl cellulose and amino acid gel, and the mass ratio of the medical hot melt adhesive, the sodium carboxymethyl cellulose and the amino acid gel is (55-80):(20-45):(0.25-5); and

[0053] (3) Release paper layer.

[0054] In the present invention, when the mass ratio, viscosity, temperature, time, number, concentration, ratio, temperature or other value or parameter is expressed as a range, a preferred range, or a range defined by a series of upper preferred values ​​and lower preferred values, it should be understood as specifically disclosing all ranges formed by any pairing of any range upper limit or preferred value with any range lower limit or preferred value, regardless of whether the range is disclosed separately. For example, when the range "55-80" is disclosed, unless otherwise specified, the range is intended to include its end values ​​and all numbers (3 decimal places) within the range, such as 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79 and 80, and the technical effects of the present invention can be achieved within the above numerical ranges.

[0055] Compared with the prior art, the present invention has the following advantages and beneficial effects:

[0056] (1) The hydrocolloid dressing provided by the present invention absorbs exudate and maintains a moist wound healing environment. At the same time, the chiral phenylalanine-based gel swells to form a chiral spatial microenvironment suitable for cell crawling and migration, which is beneficial to granulation formation and epidermal cell regeneration, can accelerate wound healing, and shorten wound healing time.

[0057] (2) The hydrocolloid dressing provided by the present invention is composed of sodium carboxymethyl cellulose and chiral phenylalanine-based gel to form a double network, which can increase the liquid absorption and penetration, can be used for wounds with a large amount of exudate, and provide a closed and moist healing environment for the wound.

[0058] In a preferred embodiment, the medical hot melt adhesive is selected from one or more of the following: polyisoprene, polyisobutylene, styrene-isoprene-styrene block copolymer and hydrogenated petroleum resin.

[0059] In a preferred embodiment, the medical hot melt adhesive is styrene-isoprene-styrene block copolymer.

[0060] The styrene-isoprene-styrene block copolymer of the invention has thermoplasticity and high elasticity, which ensures the self-adhesiveness of the dressing and makes the dressing elastic and easy to fit.

[0061] In a preferred embodiment, the viscosity of the sodium carboxymethyl cellulose is 800 mpa·s to 1200 mpa·s.

[0062] The chemical formula of sodium carboxymethyl cellulose of the present invention is [C6H7O2(OH)2OCH2COONa] n , white fibrous or granular powder, odorless, tasteless, hygroscopic, easy to disperse in water to form a transparent colloidal solution, with good water absorption and moisturizing properties. Sodium carboxymethyl cellulose comes into contact with wound exudate, forming a layer of moist gel on the wound surface, providing a moist and closed healing environment for the wound surface, absorbing wound exudate and keeping the wound non-adhesive.

[0063] In a preferred embodiment, the amino acid gel is a chiral amino acid gel.

[0064] In a preferred embodiment, the chiral amino acid gel is a chiral phenylalanine-based gel.

[0065] In a preferred embodiment, the chiral phenylalanine-based gel has the structure of the following formula I:

[0066]

[0067] The chemical formula of the phenylalanine-based gel of the present invention is C 34 H 40 N2O 10 , white powder, odorless, tasteless, can form gel in water, and has good moisturizing properties. Phenylalanine-based gel can work with sodium carboxymethylcellulose particles to create a microenvironment that promotes granulation formation and epidermal cell regeneration.

[0068] In a preferred embodiment, the mass ratio of the medical hot melt adhesive, the sodium carboxymethyl cellulose and the amino acid gel is (55-75):(20-35):(0.5-5).

[0069] In a preferred embodiment, the mass ratio of the medical hot melt adhesive, the sodium carboxymethyl cellulose and the amino acid gel is (65-75):(25-35):(0.5-1.25).

[0070] In a preferred embodiment, the mass ratio of the medical hot melt adhesive, the sodium carboxymethyl cellulose and the amino acid gel is about 70: about 30: about 1.

[0071] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 70" includes ±5% of 70, or from 66.5 to 73.5; "about 30" includes ±5% of 30, or from 28.5 to 31.5; "about 1" includes ±5% of 1, or from 0.95 to 1.05.

[0072] In a preferred embodiment, the hydrocolloid dressing is a thin hydrocolloid dressing or a common hydrocolloid dressing.

[0073] In a preferred embodiment, the hydrocolloid dressing is an adhesive-edge type hydrocolloid dressing or a non-adhesive-edge type hydrocolloid dressing.

[0074] According to another aspect of the present invention, there is provided a method for preparing the above-mentioned hydrocolloid dressing, the method comprising the following steps:

[0075] (1) Weigh an appropriate amount of medical hot melt adhesive and melt the adhesive at a certain temperature;

[0076] (2) Weighing an appropriate amount of sodium carboxymethyl cellulose and an appropriate amount of amino acid gel, slowly adding them to the medical hot melt adhesive after the sol, and stirring at a certain temperature;

[0077] (3) mixing the medical hot melt adhesive, the sodium carboxymethyl cellulose and the amino acid gel until the colloid is uniform, vacuuming and degassing, and discharging the mixture to obtain a hydrocolloid matrix material; and

[0078] (4) The hydrocolloid matrix material is transferred to a hopper of a coating machine for coating and cutting to obtain the hydrocolloid dressing.

[0079] In a preferred embodiment, in step (1), the temperature of the molten adhesive is 140°C to 160°C.

[0080] In a preferred embodiment, in step (1), the temperature of the molten adhesive is about 150°C.

[0081] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 150" includes ±5% of 150, or from 142.5 to 157.5.

[0082] In a preferred embodiment, in step (1), the melting time is 0.5 to 3 hours.

[0083] In a preferred embodiment, in step (1), the melting time is about 1 hour.

[0084] In the present invention, "about" refers to a value within the range of ±5% of a specific value. For example, "about 1" includes ±5% of 1, or from 0.95 to 1.05.

[0085] In a preferred embodiment, in step (2), the stirring temperature is 125°C to 135°C.

[0086] In a preferred embodiment, in step (2), the stirring temperature is about 130°C.

[0087] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 130" includes ±5% of 130, or from 123.5 to 136.5.

[0088] In a preferred embodiment, in step (2), the stirring time is 1 to 5 hours.

[0089] In a preferred embodiment, in step (2), the stirring time is about 3 hours.

[0090] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 3" includes ±5% of 3, or from 2.85 to 3.15.

[0091] Furthermore, in step (2), the stirring results in a paste-like semi-fluid state with no powder particles visible to the naked eye.

[0092] In a preferred embodiment, in step (3), the vacuum degassing time is 8 min to 12 min.

[0093] In a preferred embodiment, in step (3), the vacuum degassing time is about 10 minutes.

[0094] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 10" includes ±5% of 10, or from 9.5 to 10.5.

[0095] In a preferred embodiment, in step (4), before the coating, a polyurethane film layer and a release paper layer are pre-placed in the coating machine.

[0096] In a preferred embodiment, in step (4), the hydrocolloid dressing is a sheet-shaped hydrocolloid dressing.

[0097] According to another aspect of the present invention, there is provided a use of the above-mentioned hydrocolloid dressing in preparing a material for covering and / or protecting a wound.

[0098] In a preferred embodiment, the wound is a wound caused by trauma, burn, diabetic foot and / or postoperative incision.

[0099] In a preferred embodiment, the trauma is a donor site wound, a skin abrasion and / or an ulcer.

[0100] In a preferred embodiment, the burn is a superficial skin burn and / or a partial thickness burn.

[0101] The present invention will be further described below in conjunction with specific examples. It should be understood that these examples are only used to illustrate the present invention and are not intended to limit the scope of the present invention. The experimental methods in the following examples without specifying specific conditions are usually carried out according to conventional conditions or conditions recommended by the manufacturer.

[0102] Unless otherwise defined, all professional and scientific terms used herein have the same meanings as those familiar to those skilled in the art. In addition, any methods and materials similar or equivalent to those described herein can be applied to the methods of the present invention. The preferred implementation methods and materials described herein are for demonstration purposes only.

[0103] The above features mentioned in the present invention or the features mentioned in the embodiments can be combined in any way. All the features disclosed in this patent specification can be used in combination with any combination form, and each feature disclosed in the specification can be replaced by any alternative feature that can provide the same, equal or similar purpose. Therefore, unless otherwise specified, the disclosed features are only general examples of equal or similar features.

[0104] Example

[0105] 1. Experimental materials and instruments

[0106] Glue melting box (LB-200, Liben Machinery Co., Ltd., Ruian); stirring tank (SDL-200L, Liben Machinery Co., Ltd., Ruian); coating machine (LB350-10, Liben Machinery Co., Ltd., Ruian); phenylalanine-based gel (homemade); sodium carboxymethyl cellulose (commercially available); medical hot melt adhesive (commercially available); polyurethane film (commercially available); release paper (commercially available); pH meter (PHS-25, Shanghai Hongyi Instrument Co., Ltd.); 1 / 10,000 balance (Mettler); constant temperature viscosity tester (LAT-10H, Jinan Zhongce Electromechanical Equipment Co., Ltd.); intelligent electronic tensile tester (TST-01M, Jinan Zhongce Electromechanical Equipment Co., Ltd.); graphite digestion furnace (DigiPREP LS, SCE SCIENCE); inductively coupled plasma emission spectrometer (ICAP 7600, ThermoFisher); dehydrator (DIAPATH, Donatello); upright optical microscope (Nikon, Japan); EclipseE100); magnetic stirrer (Servicebio, MS-PB); freezing table (Wuhan Junjie Electronics Co., Ltd., JB-L5); tissue slide machine (Jinhua Kedi Instrument Equipment Co., Ltd., Zhejiang Province, KD-P); imaging system (Nikon, Japan, NIKON DS-U3).

[0107] The above-mentioned experimental materials and instruments of the present invention are only examples, and other commercially available experimental materials and instruments may also be used, and all of them can achieve the experimental purpose and experimental effect of the present invention.

[0108] 2. Preparation Example

[0109] Example 1

[0110] 80 kg of medical hot melt adhesive was loaded into a melt box, the temperature was set at 150°C, and the mixture was kept warm for 1 hour before being pumped into a stirring tank. 20 kg of sodium carboxymethyl cellulose was slowly added into the stirring tank, and the temperature of the stirring tank was then raised to 130°C and stirring was continued for 3 hours until the mixture became a paste-like semi-fluid state with no visible powder particles. The mixture was discharged after vacuum degassing for 10 minutes, and the evenly mixed hydrocolloid matrix material was transferred to the coating machine hopper, and a polyurethane film and release paper were placed therein and leveled, and then coated to obtain a hydrocolloid dressing with a thickness of 0.4 mm.

[0111] Example 2

[0112] 75 kg of medical hot melt adhesive was loaded into a melt box, the temperature was set at 150°C, and the mixture was kept warm for 1 hour before being pumped into a stirring tank. 25 kg of sodium carboxymethyl cellulose was slowly added into the stirring tank, and the temperature of the stirring tank was then raised to 130°C and stirring was continued for 3 hours until the mixture became a paste-like semi-fluid state with no visible powder particles. The mixture was discharged after vacuum degassing for 10 minutes, and the evenly mixed hydrocolloid matrix material was transferred to the coating machine hopper, a polyurethane film and release paper were placed therein and leveled, and then coated to obtain a hydrocolloid dressing with a thickness of 0.4 mm.

[0113] Example 3

[0114] 70 kg of medical hot melt adhesive was loaded into a melt box, the temperature was set at 150°C, and the mixture was kept warm for 1 hour before being pumped into a stirring tank. 30 kg of sodium carboxymethyl cellulose was slowly added into the stirring tank, and the temperature of the stirring tank was then raised to 130°C and stirring was continued for 3 hours until the mixture became a paste-like semi-fluid state with no visible powder particles. The mixture was discharged after vacuum degassing for 10 minutes, and the evenly mixed hydrocolloid matrix material was transferred to the coating machine hopper, and a polyurethane film and release paper were placed therein and leveled, and then coated to obtain a hydrocolloid dressing with a thickness of 0.4 mm.

[0115] Example 4

[0116] 65 kg of medical hot melt adhesive was loaded into a melt box, the temperature was set at 150°C, and the mixture was kept warm for 1 hour before being pumped into a stirring tank. 35 kg of sodium carboxymethyl cellulose was slowly added into the stirring tank, and the temperature of the stirring tank was then raised to 130°C and stirring was continued for 3 hours until the mixture became a paste-like semi-fluid state with no visible powder particles. The mixture was discharged after vacuum degassing for 10 minutes, and the evenly mixed hydrocolloid matrix material was transferred to the coating machine hopper, a polyurethane film and release paper were placed therein and leveled, and then coated to obtain a hydrocolloid dressing with a thickness of 0.4 mm.

[0117] Example 5

[0118] 60 kg of medical hot melt adhesive was loaded into a melt box, the temperature was set at 150°C, and the mixture was kept warm for 1 hour before being pumped into a stirring tank. 40 kg of sodium carboxymethyl cellulose was slowly added into the stirring tank, and the temperature of the stirring tank was then raised to 130°C and stirring was continued for 3 hours until the mixture became a paste-like semi-fluid state with no visible powder particles. The mixture was discharged after vacuum degassing for 10 minutes, and the evenly mixed hydrocolloid matrix material was transferred to the coating machine hopper, and a polyurethane film and release paper were placed therein and leveled, and then coated to obtain a hydrocolloid dressing with a thickness of 0.4 mm.

[0119] Example 6

[0120] Put 50 kg of medical hot melt adhesive into the melt box, set the temperature to 150°C, keep warm for 1 hour and then pump it into the stirring tank; slowly add 50 kg of sodium carboxymethyl cellulose into the stirring tank, then raise the temperature of the stirring tank to 130°C and continue stirring for 3 hours until it becomes a paste-like semi-fluid state with no visible powder particles, vacuum degassing for 10 minutes and then discharge the material, transfer the evenly mixed hydrocolloid matrix material to the coating machine hopper, put in polyurethane film and release paper and level it, then coat it to obtain a hydrocolloid dressing with a thickness of 0.4 mm.

[0121] Example 7

[0122] 70 kg of medical hot melt adhesive was loaded into a melt box, the temperature was set at 150°C, and the mixture was kept warm for 1 hour before being pumped into a stirring tank. 30 kg of sodium carboxymethyl cellulose was slowly added into the stirring tank, and the temperature of the stirring tank was raised to 130°C and stirred. Subsequently, 0.25 kg of phenylalanine-based gel was added and stirring was continued for 3 hours until the mixture became a paste-like semi-fluid state with no visible powder particles. The mixture was discharged after vacuum degassing for 10 minutes. The evenly mixed hydrocolloid matrix material was transferred to the coating machine hopper, and a polyurethane film and release paper were placed therein and leveled. Subsequently, coating was performed to obtain a hydrocolloid dressing with a thickness of 0.4 mm.

[0123] Example 8

[0124] 70 kg of medical hot melt adhesive was loaded into a melt box, the temperature was set at 150°C, and the mixture was kept warm for 1 hour before being pumped into a stirring tank. 30 kg of sodium carboxymethyl cellulose was slowly added into the stirring tank, and the temperature of the stirring tank was raised to 130°C and stirred. Subsequently, 0.5 kg of phenylalanine-based gel was added and stirring was continued for 3 hours until the mixture became a paste-like semi-fluid state with no visible powder particles. The mixture was discharged after vacuum degassing for 10 minutes. The evenly mixed hydrocolloid matrix material was transferred to the coating machine hopper, and a polyurethane film and release paper were placed therein and leveled. Subsequently, coating was performed to obtain a hydrocolloid dressing with a thickness of 0.4 mm.

[0125] Example 9

[0126] 70 kg of medical hot melt adhesive was loaded into a melt box, the temperature was set at 150°C, and the mixture was kept warm for 1 hour before being pumped into a stirring tank. 30 kg of sodium carboxymethyl cellulose was slowly added into the stirring tank, and the temperature of the stirring tank was raised to 130°C and stirred. Subsequently, 1 kg of phenylalanine-based gel was added and stirring was continued for 3 hours until the mixture became a paste-like semi-fluid state with no visible powder particles. The mixture was discharged after vacuum degassing for 10 minutes. The evenly mixed hydrocolloid matrix material was transferred to the coating machine hopper, and a polyurethane film and release paper were placed therein and leveled. Subsequently, coating was performed to obtain a hydrocolloid dressing with a thickness of 0.4 mm.

[0127] Example 10

[0128] 70 kg of medical hot melt adhesive was loaded into a melt box, the temperature was set at 150°C, and the mixture was kept warm for 1 hour before being pumped into a stirring tank. 30 kg of sodium carboxymethyl cellulose was slowly added into the stirring tank, and the temperature of the stirring tank was raised to 130°C and stirred. Subsequently, 1.5 kg of phenylalanine-based gel was added and stirring was continued for 3 hours until the mixture became a paste-like semi-fluid state with no visible powder particles. The mixture was discharged after vacuum degassing for 10 minutes. The evenly mixed hydrocolloid matrix material was transferred to the coating machine hopper, and a polyurethane film and release paper were placed therein and leveled. Subsequently, coating was performed to obtain a hydrocolloid dressing with a thickness of 0.4 mm.

[0129] Embodiment 11

[0130] 70 kg of medical hot melt adhesive was loaded into a melt box, the temperature was set at 150°C, and the mixture was kept warm for 1 hour before being pumped into a stirring tank. 30 kg of sodium carboxymethyl cellulose was slowly added into the stirring tank, and the temperature of the stirring tank was raised to 130°C and stirred. Subsequently, 2 kg of phenylalanine-based gel was added and stirring was continued for 3 hours until the mixture became a paste-like semi-fluid state with no visible powder particles. The mixture was discharged after vacuum degassing for 10 minutes. The evenly mixed hydrocolloid matrix material was transferred to the coating machine hopper, and a polyurethane film and release paper were placed therein and leveled. Subsequently, coating was performed to obtain a hydrocolloid dressing with a thickness of 0.4 mm.

[0131] 3. Experimental methods

[0132] 3.1. Adhesion test and peel strength test

[0133] Adhesion test: According to "YY / T1293.4-2016 Contact Wound Dressing Part 4: Hydrocolloid Dressing 7.2.3", remove the protective layer of the hydrocolloid dressing, cut a 25mm wide sample, and the adhesive surface of one end of the sample is in contact with the clean surface of the stainless steel plate, so that the entire width of the end of the sample is aligned with 25mm from the end of the steel plate, and the two sides of the sample are parallel to the long side of the steel plate. The unadhered end of the sample hangs outside the end of the steel plate. Use a metal cylindrical roller with a diameter of 50mm to apply pressure to the adhesive part of the sample, roll it four times along the length direction of the sample at a speed of about 60cm / min, and let it stand for 10min under standard atmospheric pressure. Make a mark line on the end line of the sample, and attach a weight of 0.8N (80g) per centimeter width to the hanging end of the sample. The force should be evenly distributed over the entire bandwidth. Hang the steel plate in a hot air oven at 36℃~38℃ for 30 minutes, tilt the steel plate 2° from the vertical plane, and record the sliding distance of the top of the sample.

[0134] Peel strength test: According to "YY / T1293.4-2016 Contact Wound Dressing Part 4: Hydrocolloid Dressing 7.2.4", the hydrocolloid dressing sample is attached to the center of the clean surface of the stainless steel plate, so that the two sides of the sample are parallel to the two long sides of the steel plate. Use a roller to apply pressure to the attached part of the sample, and roll it four times along the length direction of the sample at a speed of about 60cm / min. Let it stand for 10 minutes under standard atmospheric pressure. Use a force measuring instrument to measure the force required to peel the sample from the steel plate (the force angle is 180°, and the peeling speed is 270mm / min~330mm / min). Observe the force applied at the first 25mm length, observe the force every 30mm, and take the average of the six readings.

[0135] 3.2 Water absorption test and integrity test

[0136] The medical hydrocolloid dressing was pressed into a sheet with a thickness of 1 mm, punched into a sample of 25×25 mm, and a polyurethane film was attached to one side of the sample. The sample was weighed and recorded as m1, and placed in isotonic saline at a temperature of 37°C. After 24 hours, one corner of the sample was clamped with tweezers and hung for 30 seconds. After absorbing the moisture on the side not attached with the polyurethane film, the sample was weighed and recorded as m2.

[0137] Water absorption = (m1-m2) / (2.5×2.5)×10000 Formula 1

[0138] The medical hydrocolloid dressing is pressed into a sample with a diameter of 30mm and a thickness of 1mm, and a polyurethane film is attached to one side of the sample. The sample is weighed and recorded as W1. 150ml of isotonic saline is placed in a conical flask with a volume of 250ml, and the sample is added. The bottle mouth is sealed and then placed in a shaker. The shaker temperature is set to 37℃ and the speed is 10r / min. Keeping the experimental conditions unchanged, take out the sample after 24 hours, put it in a blast drying oven, dry it at 60℃ for 24 hours, and then weigh it and record it as W2.

[0139] Integrity = (W1-W2) / W1×100% Formula 2

[0140] 3.3 Animal Experimental Methods

[0141] After removing the back hair and disinfecting the back, a full-thickness skin defect wound (3 cm in diameter) was established on the back of the rat under sterile conditions. In order to induce a skin ulcer model, the depth was ensured to reach the fascia layer. After modeling, 54 mice were divided into a control group, a KHJ group (corresponding to Example 9), and an NFS group (Nicefull Medical) using a random number table method. TM Naifusheng TM Hydrocolloid dressing, which consists of a polyurethane backing, a hydrocolloid wound protection layer and treated low-density polyethylene protection paper; the raw materials of the hydrocolloid wound protection layer are pectin, sodium hydroxymethyl cellulose, mineral oil, polystyrene-isoprene resin polymer, hydrocarbon, polybutylene, polyisobutane and propylene oxide polyethylene polymer), 18 mice in each group. The three groups of mice were given the corresponding sample dressings (the control group used medical gauze) and fixed with 3M patch.

[0142] The wound surface was photographed on the 7th, 14th and 21st days after modeling (each animal was photographed at a distance of 10 cm above the wound surface and using automatic exposure mode), and the wound area was calculated using area calculation software. The area between the wound edge and the epidermal crawling front was defined as the unhealed area.

[0143] The wound healing rate was calculated as:

[0144]

[0145] In the formula: R——wound healing rate;

[0146] A0——initial wound area;

[0147] A t ——The area of ​​the wound at time t.

[0148] 4. Experimental results

[0149] 4.1 Effect of rubber substrate on the performance of hydrocolloid dressings

[0150] Different mass ratios of rubber substrate (styrene-isoprene-styrene thermoplastic rubber, SIS) and sodium carboxymethyl cellulose (CMC) were selected to investigate their effects on the persistence, peel strength and water absorption of hydrocolloid dressings, and the optimal dosage ratio was determined experimentally. The results of the design of different mass ratios of SIS and CMC and their effects on the performance of hydrocolloid dressings are shown in Table 1.

[0151] Table 1 Content formula design and its effect on the performance of hydrocolloid dressings

[0152]

[0153] As can be seen from Table 1, for hydrocolloid dressings, the adhesion and peel strength decrease as the SIS content of the rubber substrate decreases. When the hot melt adhesive content is high, the adhesion is good and it is not easy to fall off in the adhesion test. When the adhesion is insufficient, displacement will occur. For example, the adhesion of Example 6 has caused the hydrocolloid dressing sample to slide down on the steel plate, indicating that the adhesion is insufficient. However, the adhesion and peel strength are not the greater the better. When the mass ratio of the rubber substrate (SIS) to sodium carboxymethyl cellulose (CMC) is greater than 80:20, on the one hand, the adhesion is too strong. When the peel strength is too high, the hydrocolloid dressing will feel tight when attached to the skin, the comfort is reduced, and it will be painful when peeled from the skin, which is easy to damage the skin; on the other hand, too high SIS content means that the CMC content is reduced, and its water absorption will be significantly reduced, resulting in insufficient absorption capacity for exudate at the wound surface. By comprehensively balancing the two indicators of adhesion and peel strength, the mass ratio of rubber substrate (SIS) to sodium carboxymethyl cellulose (CMC) of 70:30 was selected as the best ratio (the peel strength has an inflection point between 70:30 and 65:35, and the peel strength decreases significantly after 70:30).

[0154] 4.2 Effect of hydrocolloids on the performance of hydrocolloid dressings

[0155] Absorption of exudate is one of the main functions of hydrocolloid dressings. After the hydrocolloid dressing absorbs water, the hydrocolloid dispersed in the rubber will swell, and the swelling will cause the dressing to lose its integrity. Therefore, it is necessary to further investigate the effect of the ratio of CMC and phenylalanine-based gel content on the softness and water absorption of hydrocolloid dressings. The results of the content formula design and the effect of hydrophilic colloid on the performance of hydrocolloid dressings are shown in Table 2.

[0156] Table 2 Effect of formulation design and hydrophilic colloid on the performance of hydrocolloid dressings

[0157]

[0158] As can be seen from Table 2, the water absorption increases with the increase of phenylalanine-based gel content, but the integrity decreases rapidly. When the mass ratio of phenylalanine-based gel is lower than 30:0.25, it is impossible to construct a complete chiral space microenvironment suitable for cell crawling and migration, and when the mass ratio of phenylalanine-based gel is higher than 30:2, it is not conducive to the integrity of the hydrocolloid dressing after absorbing the exudate. After comprehensive consideration, the mass ratio of sodium carboxymethyl cellulose (CMC) to phenylalanine-based gel of 30:1 is determined to be the best ratio (the integrity has an inflection point between 30:1 and 30:1.5, and the integrity decreases significantly after 30:1).

[0159] 4.3 Animal Experiment Results

[0160] No infection occurred in any group of animals, and no death occurred. On the 7th day after surgery, there was no obvious redness, swelling, or exudate in the wounds of any group of animals, and the wound surface was significantly reduced compared to before surgery. Among them, the wound surface recovery in the NFS and KHJ dressing groups was better. On the 14th day after surgery, the wound surface area was further reduced. On the 21st day after surgery, the wound surface in the KHJ group was basically healed, and the wound surface was covered with new epidermis. The wound surface recovery in the NFS and KHJ groups was better than that in the control group. Figure 2 shown.

[0161] On the 7th, 14th and 21st days after surgery, the healing rates of the NSF and KHJ groups were significantly higher than those of the control group. The KHJ hydrocolloid dressing group had a significant effect in promoting wound healing. The results are shown in Table 3.

[0162] Table 3 Healing rate of each group after surgery (x±s, %)

[0163]

[0164] in, a Compared with the control group, p<0.05, n=6, b Compared with the NFS group, p<0.05, n=6.

[0165] The embodiments of the present invention are described in detail above. Specific examples are used herein to illustrate the principles and implementation methods of the present invention. The description of the above embodiments is only used to help understand the method of the present invention and its core idea. At the same time, changes or deformations made by those skilled in the art based on the ideas of the present invention, the specific implementation methods and application scope of the present invention, all belong to the scope of protection of the present invention. In summary, the content of this specification should not be understood as limiting the present invention.

Claims

1. A hydrocolloid dressing, characterized in that: The hydrocolloid dressing comprises (1) Polyurethane film layer; (2) a hydrocolloid matrix layer, wherein the hydrocolloid matrix comprises medical hot melt adhesive, sodium carboxymethyl cellulose and amino acid gel, and the mass ratio of the medical hot melt adhesive, the sodium carboxymethyl cellulose and the amino acid gel is (55-80):(20-45):(0.25-5); and (3) Release paper layer.

2. The hydrocolloid dressing according to claim 1, characterized in that: The medical hot melt adhesive is selected from one or more of the following: polyisoprene, polyisobutylene, styrene-isoprene-styrene block copolymer and hydrogenated petroleum resin; Preferably, the medical hot melt adhesive is styrene-isoprene-styrene block copolymer; More preferably, the viscosity of the sodium carboxymethyl cellulose is 800 mpa·s to 1200 mpa·s; Still more preferably, the amino acid gel is a chiral amino acid gel; Particularly preferably, the chiral amino acid gel is a chiral phenylalanine-based gel; Particularly preferably, the chiral phenylalanine-based gel has the structure of the following formula I: Particularly preferably, the mass ratio of the medical hot melt adhesive, the sodium carboxymethyl cellulose and the amino acid gel is (55-75):(20-35):(0.5-5); Particularly preferably, the mass ratio of the medical hot melt adhesive, the sodium carboxymethyl cellulose and the amino acid gel is (65-75):(25-35):(0.5-1.25); Particularly preferably, the mass ratio of the medical hot melt adhesive, the sodium carboxymethyl cellulose and the amino acid gel is about 70: about 30: about 1; Particularly preferably, the hydrocolloid dressing is a thin hydrocolloid dressing or a common hydrocolloid dressing; Still more preferably, the hydrocolloid dressing is an adhesive-edge type hydrocolloid dressing or a non-adhesive-edge type hydrocolloid dressing.

3. A method for preparing the hydrocolloid dressing according to claim 1 or 2, characterized in that: The method comprises the following steps: (1) Weigh an appropriate amount of medical hot melt adhesive and melt the adhesive at a certain temperature; (2) Weighing an appropriate amount of sodium carboxymethyl cellulose and an appropriate amount of amino acid gel, slowly adding them to the medical hot melt adhesive after the sol, and stirring at a certain temperature; (3) mixing the medical hot melt adhesive, the sodium carboxymethyl cellulose and the amino acid gel until the colloid is uniform, vacuuming and degassing, and discharging the material to obtain a hydrocolloid matrix material; and (4) The hydrocolloid matrix material is transferred to a hopper of a coating machine for coating and cutting to obtain the hydrocolloid dressing.

4. The method according to claim 3, characterized in that In step (1), the temperature of the molten adhesive is 140° C. to 160° C.; Preferably, the temperature of the molten adhesive is about 150°C; More preferably, the melting time is 0.5 to 3 hours; More preferably, the melting time is about 1 hour.

5. The method according to claim 3, characterized in that: In step (2), the stirring temperature is 125°C to 135°C; Preferably, the stirring temperature is about 130°C; More preferably, the stirring time is 1 to 5 hours; More preferably, the stirring time is about 3 hours; Particularly preferably, the stirring results in a paste-like semi-fluid state without visible powder particles.

6. The method according to claim 3, characterized in that In step (3), the vacuum degassing time is 8 min to 12 min; Preferably, the vacuum degassing time is about 10 minutes.

7. The method according to claim 3, characterized in that In step (4), before the coating, a polyurethane film layer and a release paper layer are pre-placed in the coating machine; Preferably, the hydrocolloid dressing is a sheet-shaped hydrocolloid dressing.

8. Use of the hydrocolloid dressing according to claim 1 or 2 in the preparation of a material for covering and / or protecting a wound; Preferably, the wound is a wound caused by trauma, burn, diabetic foot and / or postoperative incision; More preferably, the trauma is a donor site wound, a skin abrasion and / or an ulcer; Also preferably, the burns are superficial epidermal burns and / or partial-thickness burns.

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