CN1121876C - Hydrogel compounded dressing for wound and its radiation synthesis process - Google Patents

Hydrogel compounded dressing for wound and its radiation synthesis process Download PDF

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Publication number
CN1121876C
CN1121876C CN 00107403 CN00107403A CN1121876C CN 1121876 C CN1121876 C CN 1121876C CN 00107403 CN00107403 CN 00107403 CN 00107403 A CN00107403 A CN 00107403A CN 1121876 C CN1121876 C CN 1121876C
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hydrogel
dressing
radiation
wound
film
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CN 00107403
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CN1273128A (en
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王家驹
许零
罗志武
李涛
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China Institute of Atomic of Energy
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China Institute of Atomic of Energy
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Abstract

The present invention relates to a compounded dressing for wounds, which is composed of hydrogel and a polymer film, wherein the hydrogel synthesized by irradiation and connection has high water absorption, and the polymer film ventilates air and moisture. The radiation synthesis method has the steps: mixing materials for the hydrogel with water; pouring the mixture into a mould; radiating the mould by an electron beam or gamma-rays with the radiation dose of 15 to 100kGy after the mixture in the mould is solidified; covering one surface of the hydrogel with a ventilation film, and covering the other surface with a release film if necessary; radiating the final product for sterilization after the processes of cutting and bagging. With the advantages of favorable transparence, high water absorption, ventilation property, moisture permeability and no water permeability, the present invention can prevent wound infection and accelerate recovery. The present invention is suitable for protecting and treating the wound surfaces of burns, scalds, bedsores and other traumatic wounds. After radiating for sterilization, the present invention can be stored for a long time.

Description

Hydrogel compounded dressing for wound and radiation synthesis process thereof
The present invention relates to a kind of compounded dressing for wound that is applicable to burn, scald, decubital ulcer and traumatic wounds protecting wound surface and treatment, its composition and preparation method.
The wound dressing that is used to protect and heals a wound can be divided three classes:
1. universal-as on wound surface, to apply plaster, with parcels such as gauze, binder, protection wound.This method can not intercept antibacterial, non-watertight, has brought great inconvenience for patient's daily life.What is more important, gauze, binder etc. normal with skin, tissue adhesion, when changing dressings, bring great misery also often to cause wound to break once more to the patient.
2. biotype-make by animal skins, sponge, amniotic membrane, the former film of erosion, membrane plasmapheresis etc.This material has air permeability and good and biocompatibility, has alleviated the misery when patient changes dressings.But this material needs cryopreservation, costs an arm and a leg, and has restricted its popularization and use.
3. compound-as to make from synthetic polymer, and make shapes such as foam, paste, film, fabric.Such wound dressing is suitable for commercial production and promotes the use of, and has good water absorption and breathable moisture permeability.
Be used at present to burn, the compounded dressing for wound of protecting wound surface such as scald, decubital ulcer, wound and treatment mainly contains following several types:
1. coating medical pressure sensitive adhesive on back lining materials such as polrvinyl chloride, polyethylene, polypropylene, non-woven fabrics, polyurethane sticks on the film that makes on the wound surface.Can influence the skin eupnea with air-locked materials such as polrvinyl chloride, polyethylene, polypropylene as back lining materials, and they do not have water absorption.The long-term subsides use this material, skin to be subjected to the etch of sweat, Wound exudate and produced untoward reaction such as allergy, also comes off easily after the adhesive on the film soaks and influences treatment.The polyurethane backing has air permeability and good, but also there is the defective that does not absorb water in it.Non-woven fabrics is made backing and can be breathed freely and can absorb transpiring moisture, but its open-celled structure can't intercept antibacterial; And it is opaque, can not in time observe the wound healing situation; The probability that can not get rid of itself and tissue adhesion when changing dressings.
2. three layers of compound wound dressing.Usually use ventilative continuous film as the protection backing layer; Non-woven fabrics, foamed materials or fabric etc. are as the occlusion backing layer; Be composited for three layers with the adhesion layer of skin adhesive.This structure has certain breathability and water absorbing capacity, but its water absorbing capacity is not strong, and opaque, has influenced the wound observation.
3. hydrogel compounded dressing for wound.This class dressing is composited by several parts such as ventilative continuous film, non-woven fabrics or fabric skeleton, hydrogel, adhesive usually.Because hydrogel has good intensity, pliability and breathability; therefore it can provide moistening, a gas-pervious a home from home to wound surface; and can cushion the extraneous impulsive force that gives wound surface, and be a kind of protecting wound surface material truly, be particularly useful for transudate wound more the more.
CN1044405 discloses and a kind ofly can absorb wound fluid, and can be with water transport to airborne binder.This binder be by thin film such as polyester, polyethylene as the protection backing, pasting one deck on the protection backing is that the hydrogel of skeleton is made with fabric or non-woven fabrics.The base material of hydrogel comprises sodium carboxymethyl cellulose, various polypropylene amine, polyacrylonitrile and acrylate copolymer etc.The shortcoming of this hydrogel is opaque.
CN1095916 discloses a kind of wound dressing that can absorb wound fluid.It forms the sealing top layer by polyurethane film and polymer filament net, absorbed layer is composited by mixture, the polypropylene fibre second layer of polypropylene fibre ground floor, hydrocolloid and superabsorbents, is the polymer base coat made of polyvinylpyrrolidone or polyvinyl alcohol and moisturely separates colloidal adhesive phase with skin directly contacts.This invention weighing-appliance has excellent water absorption, but it is to reach multi-layer compound structure that ideal intensity and water absorption design to have sacrificed and be beneficial to the transparency of observing wound.
CN2292547 discloses a kind of water absorption medical dressing of not sticking wound, and water accepting layer that it is made by the micropore non-woven fabrics that scribbles acrylic compounds water-absorbing resins film and the basic unit made from fabric or breathability non-woven fabrics form.This dressing except that have aforesaid opaque, do not intercept the shortcoming such as antibacterial, also lack ideal performances such as pliability that wound dressing should possess and elasticity, in addition, the residual monomer of acrylic resin usually has skin to stimulate or slight toxic and side effects.
US5674523 discloses a kind of aquogel type wound dressing with autohension, and it is formed by polyurethane film, polyolefin silk screen, hydrogel lamination.Its characteristics are to make strip, can be surrounded on positions such as wrist; The polyolefin silk screen has a rectangle can observe the window of wound above wound.
US4871490 discloses a kind of manufacture method of aquogel type wound dressing.With components such as polyacrylamide, polyvinylpyrrolidone, gelatin, Polyethylene Glycol with different mixed, be mixed with the aqueous solution that concentration is 2-20%, aqueous solution poured in the mould with definite shape be shaped, use at last more than the electron beam irradiation 25kGy, become hydrogel with good water absorbing properties.But the residual monomer of its employed polyacrylamide is toxic and stimulation to human body.
EP0450671 discloses a kind of preparation method of wound dressing.This dressing is made of the hydrogel layer of breathability high-polymer membrane, fibrous layer, crosslinking with radiation.This invention claims the breathability high-polymer membrane to choose from materials such as silicone rubber, polyurethane, polyether-polyester copolymer; In order to promote the bonding force of notacoria and hydrogel, between them, place fabrics such as polyester, polyamide, polyurethane as interlayer; Hydrogel is made up of polyvinyl alcohol and antibacterial, with the preparation of crosslinking with radiation method.
Though existing these aquogel type wound dressings have solved problems such as absorption transudate, breathability, obstruct antibacterial, waterproof, wound comfort level, but for the intensity that increases hydrogel, the cohesive that strengthens hydrogel and waterproof and breathable notacoria, majority has all adopted fabric or non-woven fabrics as enhancement Layer, and has taked the complicated technology of MULTILAYER COMPOSITE.Like this, goods are opaque structure, have influenced the observation of wound healing situation.
The object of the present invention is to provide and a kind ofly can absorb transudate, can intercept antibacterial; have transparent, ventilative, waterproof, not with characteristics such as tissue adhesion, pliability be good, be applicable to the hydrogel compounded dressing for wound of protecting wound surfaces such as burn, scald, decubital ulcer, traumatic wounds and treatment.
Another object of the present invention is composition and the radiation synthesis process thereof that proposes this wound dressing.
Hydrogel compounded dressing for wound of the present invention is made up of gas permeable polymers film and hydrogel layer, and wherein the hydrogel water content is by weight 75-95%, and the degree of cross linking of hydrogel is 75-95%, water absorption rate 200-400%.
Wherein hydrogel is to be selected from one or more Jia Jibingxisuanβ-Qiang Yizhis, acrylate, polyvinylpyrrolidone, polyvinyl alcohol, polyethylene glycol oxide, monomers such as Polyethylene Glycol or polymer formulation become the aqueous solution after fixing, are selected from the electron beam of 15-100kGy or gamma-radiation cross-linking radiation and the hydrogel that forms through irradiation dose.
Wherein employed polymer is selected from polyvinylpyrrolidone in the hydrogel, polyvinyl alcohol and/or polyethylene glycol oxide.
Wherein the proportioning of polyvinylpyrrolidone and polyvinyl alcohol is by weight 0: 14 to 14: 0, and the content of polyethylene glycol oxide is the 0-10% of hydrogel gross weight.
Wherein the proportioning of polyvinylpyrrolidone and polyvinyl alcohol is to measure meter according to quantity 4: 10 to 10: 4.
Wherein the thickness of hydrogel is 0.5 to 10 millimeter.
Wherein the employed polymer of gas permeable polymers film is selected from polyethylene, polrvinyl chloride, silicone rubber, polyurethane or polyimides.
Wherein can cover release paper or the stripping film that one deck scribbles silicone on the hydrogel.
The radiation synthesis process of hydrogel compounded dressing for wound of the present invention, be that material and the water that described hydrogel is used mixes, solution casting is in mould, solidify the back is selected from 15-100kGy with irradiation dose electron beam or gamma-radiation irradiation, the one side of hydrogel covers the gas permeable polymers film, cutting, sterilizes with method of radiating in the pack back.
If wherein must or need, scribble the release paper or the stripping film of silicone at another side covering one deck of hydrogel.
The wound dressing that the present invention proposes comprises the polymeric film of breathability, with synthetic hydrogel of crosslinking with radiation method and the release paper or the polymeric film that scribble silicone.
The polymeric film of breathability shields to the absorbed layer, under the prerequisite of keeping the skin eupnea, prevents the moisture excessive vaporization of hydrogel, prevents the antibacterial intrusion, and plays the potentiation of hydrogel.This film must be a kind of continuous film of better softness, and material can be chosen from polymer such as polyethylene, polrvinyl chloride, silicone rubber, polyurethane, polyimides.Preferred material is a polyurethane, and its moisture-vapor transmission is greater than 300g/m 224h.The thickness of film is selected 25-100 micron, preferred thickness 25-50 micron.
Hydrogel as absorbed layer among the present invention is synthetic with the method for crosslinking with radiation, and the degree of cross linking of synthetic water gel is up to 75-95%, and water absorption rate 200-400% has good intensity.Another advantage of crosslinking with radiation synthetic water gel is not need to add initiator, and the normally deleterious chemical substance of chemical initiator, therefore with the synthetic purity that can keep system of method of radiating.
The raw material of synthetic water gel adopts the water-soluble polymer or the monomer of good biocompatibility, no human body toxic and side effects, comprises Jia Jibingxisuanβ-Qiang Yizhi, acrylic polymer, polyvinylpyrrolidone, polyvinyl alcohol, polyethylene glycol oxide, Polyethylene Glycol etc.Preferred material is polyvinylpyrrolidone (PVP), polyvinyl alcohol (PVA), polyethylene glycol oxide (PEO).From above material, choose one or more, be mixed and made into solution, solution-cast in mould, after the cold curing molding, is made it crosslinked with electron beam or gamma-ray irradiation with suitable proportioning.
The proportioning of polyvinylpyrrolidone and polyvinyl alcohol is 0/14-14/0 (w/w) in the hydrogel, and optimum ratio is 4/10-10/4 (w/w), and the content of polyethylene glycol oxide is the 0-10wt% of hydrogel gross weight.The water content of hydrogel is 75-95wt%.The thickness of hydrogel is the 0.5-10 millimeter, and preferred thickness is the 2-4 millimeter.Electron beam or gamma-ray irradiation dose are selected 15-100kGy, preferably between 25-50kGy.
Cover on the hydrogel, peel ply palpus and the hydrogel that abandons that need tear it down before use has certain bonding force, but tears it down easily.The material of this one deck can adopt stripping films such as the release paper that scribbles silicone, polyethylene film, polypropylene screen, polychloroethylene film.
In order to improve the bond properties of ventilated membrane and hydrogel, can carry out surface treatment to ventilated membrane, apply adhesion layer at ventilated membrane surface-coated medical adhesive or in hydrogel surface with viscosity, adopt one of above-mentioned method or several method to be used in combination, can obtain satisfied bonding force.
Ventilated membrane described in the literary composition, hydrogel, stripping film is compound, cut into certain specification, after packing with waterproof, air-locked packaging bag, at last with electron beam or gamma-ray irradiation sterilization.Hydrogel through irradiation sterilization can be stored at normal temperatures, and storage period is more than 2 years.Fix with transparent gas-pervious medical adhesive tape during use, can make it bonding more firm, and keep its waterproof, function such as ventilative.
The live part of this wound dressing is made up of the polymer continuous film of synthetic high-hydroscopicity hydrogel of method of radiating and breathability, and with transparent gas-pervious pressure sensitive adhesive tape it and skin is fixed.The protecting wound surface that this wound dressing is used for above-mentioned several wounds has following characteristics: have high-hydroscopicity, can absorb wound fluid effectively; Have the sealing top layer, can intercept antibacterial effectively, prevent wound infection; Contain a large amount of water, and have ventilative, wet and good intensity and pliability thoroughly, can provide good comfort level to wound surface, and can promote the healing of wound; Have good transparency, be convenient to observe the wound healing situation; Not with skin and tissue adhesion, patient's no pain during replacing can not cause the secondary wound; Prescription all adopts good biocompatibilities, to the material that human body has no side effect, goods are through strict sterilization; Have excellent waterproof, slip-off preventing performance, do not influence that the patient has a bath and daily routines such as normal activity.This wound dressing is applicable to the protecting wound surface and the treatment of burn, scald, decubital ulcer and traumatic wounds.
[embodiment 1]
With 8 gram PVA, 92 gram water mix, and are mixed with the PVA aqueous solution of 8wt%, and aqueous solution is cast in the culture dish, and cold curing was used gamma-ray irradiation 15kGy after 1 hour.Simultaneously cover the polyurethane film that scribbles medical pressure-sensitive adhesive at the hydrogel that makes, another side covers polyethylene film, cuts the plastic bag sealing of packing into after the shaping, sterilizes with gamma-ray irradiation.
The degree of cross linking of hydrogel is 80%, water absorption rate 170%, hot strength 270g/cm 2, elongation at break 230%.[embodiment 2]
With 15 gram PVP, 85 gram normal saline mix, and the PVP normal saline solution of preparation 15wt% casts in aqueous solution in the culture dish, and cold curing at the polyethylene film that its surperficial applying layer of surface is handled, was used gamma-ray irradiation 25kGy after 1 hour.Paste release paper at the another side of hydrogel, cut subsequently, pack, irradiation sterilization.
The degree of cross linking of hydrogel is 94%, water absorption rate 260%, hot strength 445g/cm 2, elongation at break 250%.[embodiment 3]
With 4 gram PVA, 10 gram PVP, 86 gram water mix, and being mixed with the solution solid content is the PVA/PVP mixed solution of 14wt%.Solution-cast is in mould, and cold curing applies one deck pasty state PVA solution after 1 hour in its surface, uses electron beam irradiation 25kGy.Cover polyurethane film in the one side of hydrogel, another side covers polychloroethylene film, cuts, pack, radiation sterilization.
The degree of cross linking of hydrogel is 90%, water absorption rate 320%, hot strength 340g/cm 2, elongation at break 280%.[embodiment 4]
With 3 gram PVA, 7 gram PVP, 90 gram water mix, and being mixed with the solution solid content is the PVA/PVP mixed solution of 10wt%.Solution-cast is in mould, and cold curing applies one deck pasty state PVA solution after 1 hour in its surface, uses electron beam irradiation 40kGy.Cover silicone rubber membrane in the one side of hydrogel, another side covers polychloroethylene film, cuts, pack, radiation sterilization.
The degree of cross linking of hydrogel is 85%, water absorption rate 230%, hot strength 300g/cm 2, elongation at break 250%.[embodiment 5]
With the PVA10 gram, the PVP4 gram, water 86 grams mix, and being mixed with the solution solid content is the PVA/PVP mixed solution of 14wt%.Solution-cast is in mould, and cold curing was used electron beam irradiation 50kGy after 1 hour.Cover polychloroethylene film in the one side of hydrogel, another side covers polypropylene screen, cuts, pack, irradiation sterilization.
The degree of cross linking of hydrogel is 84%, water absorption rate 230%, hot strength 280g/cm 2, elongation at break 260%.[embodiment 6]
With the PVA12 gram, the PEO8 gram, water 80 grams mix, and being mixed with the solution solid content is the PVA/PEO mixed solution of 20wt%.Solution-cast is in mould, and cold curing was used electron beam irradiation 90kGy after 1 hour.Cover Kapton in the one side of hydrogel, another side covers polypropylene screen, cuts, pack, irradiation sterilization.
The degree of cross linking of hydrogel is 82%, water absorption rate 240%, hot strength 380g/cm 2, elongation at break 350%.
The performance of the aquogel type wound dressing that the present invention makes is as follows: 1. the degree of cross linking: 80-95%
Method of testing: hydrogel is contained in the copper mesh of sealing, places the beaker that fills deionized water, beaker was placed in the high steam pot that temperature is set to 125 ℃ heating two hours; Deionized water in the beaker is outwelled, changed new deionized water, reheat two hours; Repeat last step.At last copper mesh is taken out and dry to constant weight.Calculate the weight before and after the hydrogel extraction, the percentage ratio that the part that is insoluble to hot water accounts for the hydrogel solid amount is the degree of cross linking.2. water absorption rate: 200-400%
Method of testing: hydrogel was soaked in deionized water 5 days, wipe surperficial redundant moisture and weigh.The part (being the moisture of absorbed) of hydrogel weightening finish is water absorption rate with the percentage ratio of hydrogel original weight.3. hot strength: 250-500g/cm 2Elongation at break: 100%-400%
Method of testing: hydrogel is cut into the dumb-bell shape batten, tests with the WD-10D type hot strength instrument of the Changchun second testing machine factory.4. water vapour permeability: 800g/m 224h (37 ℃, relative humidity 55%)
Method of testing: press ASTM E96-80 standard.5. transparency: 75-85%
Method of testing: survey transmitance at 700nm with day UV-365 type spectrophotometer in island proper Tianjin.6. antibacterial permeability: antibacterial does not see through
Method of testing: placing cultivation in the one side of hydrogel has colibacillary Nutrient agar, places 37 ℃ incubator, takes out the bacterial growth situation of observing the hydrogel another side after 5 days.7. bacterial content: do not detect
Method of testing: press the GB4789.2-94 standard.

Claims (12)

1. a hydrogel compounded dressing for wound is characterised in that by gas permeable polymers film and hydrogel layer and forms that wherein the hydrogel water content is by weight 75-95%, and the degree of cross linking of hydrogel is 75-95%, water absorption rate 200-400%; Above-mentioned hydrogel is to be selected from one or more Jia Jibingxisuanβ-Qiang Yizhis, acrylate, polyvinylpyrrolidone, polyvinyl alcohol, polyethylene glycol oxide, Polyethylene Glycol.
2. dressing according to claim 1, it is characterized in that, described hydrogel is to be selected from one or more Jia Jibingxisuanβ-Qiang Yizhis, acrylate, polyvinylpyrrolidone, polyvinyl alcohol, polyethylene glycol oxide, the monomer of Polyethylene Glycol or polymer formulation become the aqueous solution after fixing, select the electron beam of 15-100kGy or gamma-radiation cross-linking radiation and the hydrogel that forms through irradiation dose.
3. dressing according to claim 2 is characterized in that employed polymer is selected from polyvinylpyrrolidone in the hydrogel, polyvinyl alcohol and/or polyethylene glycol oxide.
4. dressing according to claim 3 is characterized in that the proportioning of polyvinylpyrrolidone and polyvinyl alcohol is by weight 0: 14 to 14: 0, and the content of polyethylene glycol oxide is the 0-10% of hydrogel gross weight.
5. dressing according to claim 4 is characterized in that the proportioning of polyvinylpyrrolidone and polyvinyl alcohol is by weight 4: 10 to 10: 4.
6. according to the described dressing of arbitrary claim among the claim 1-5, the thickness that it is characterized in that hydrogel is 0.5 to 10 millimeter.
7. according to the described dressing of arbitrary claim among the claim 1-5, it is characterized in that the employed polymer of gas permeable polymers film is selected from polyethylene, polrvinyl chloride, silicone rubber, polyurethane or polyimides.
8. according to the described dressing of arbitrary claim among the claim 1-5, it is characterized in that to cover on the hydrogel release paper or the stripping film that one deck scribbles silicone.
9. dressing according to claim 6, the thickness that it is characterized in that hydrogel are 2 to 4 millimeters.
10. according to the radiation synthesis process of the described dressing of arbitrary claim among the claim 1-5, it is characterized in that material that described hydrogel is used and water mix, solution casting is in mould, solidify 15-100kGy is selected in the back with irradiation dose electron beam or gamma-radiation irradiation, the one side of hydrogel covers the gas permeable polymers film, cut pack, radiation sterilization.
11. radiation synthesis process according to claim 10 is characterized in that covering release paper or the stripping film that one deck scribbles silicone at the another side of hydrogel.
12. radiation synthesis process according to claim 10 is characterized in that irradiation dose selects electron beam or the gamma-radiation irradiation of 25-50kGy.
CN 00107403 1999-08-12 2000-05-11 Hydrogel compounded dressing for wound and its radiation synthesis process Expired - Fee Related CN1121876C (en)

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