CN112870427A - Hydrogel elastic patch and preparation method thereof - Google Patents

Hydrogel elastic patch and preparation method thereof Download PDF

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Publication number
CN112870427A
CN112870427A CN202110271604.XA CN202110271604A CN112870427A CN 112870427 A CN112870427 A CN 112870427A CN 202110271604 A CN202110271604 A CN 202110271604A CN 112870427 A CN112870427 A CN 112870427A
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hydrogel
elastic
elastic material
percent
material layer
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陈倩
张成裕
尤勇
吴亚健
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Shanghai Chuangshi Medical Technology Group Co Ltd
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Shanghai Chuangshi Medical Technology Group Co Ltd
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Priority to CN202110271604.XA priority Critical patent/CN112870427A/en
Publication of CN112870427A publication Critical patent/CN112870427A/en
Priority to PCT/CN2022/080351 priority patent/WO2022188861A1/en
Priority to US18/033,371 priority patent/US20230381371A1/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42Use of materials characterised by their function or physical properties
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/02Adhesive bandages or dressings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/18Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing inorganic materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/24Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/28Polysaccharides or their derivatives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42Use of materials characterised by their function or physical properties
    • A61L15/44Medicaments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/602Type of release, e.g. controlled, sustained, slow
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/80Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special chemical form
    • A61L2300/802Additives, excipients, e.g. cyclodextrins, fatty acids, surfactants

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  • Health & Medical Sciences (AREA)
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Abstract

The invention provides a hydrogel elastic patch and a preparation method thereof, wherein the elastic patch comprises an elastic material layer, a high polymer hydrogel layer with a slow release function and a release covering layer which are sequentially arranged; the elastic material layer is an elastic material layer compounded with a hydrophobic auxiliary agent, or a material layer formed by compounding an elastic material and a waterproof material, or an elastic material layer with an air layer structure. According to the invention, through carrying out hydrophobic treatment on the elastic material layer or compounding the elastic material with a waterproof material or the elastic material layer with an air layer structure, the risk that the elastic cloth is combined with hydrogel and is easy to penetrate is solved, and the advantage of good air permeability of the elastic cloth is retained. The hydrophilic polymer hydrogel has good skin-friendly property and skin permeability, long drug release time, good biological adhesiveness with skin, repeated uncovering and pasting, no residual colloid, and good adhesiveness even if a user sweats.

Description

Hydrogel elastic patch and preparation method thereof
Technical Field
The invention relates to the technical field of medicines and medical instruments, in particular to a hydrogel elastic patch and a preparation method thereof.
Background
Because people pay more and more attention to health, frequent sports, muscle strain is inevitable, or muscle needs to be protected before sports, but the traditional products on the market are easy to fall off due to sweating in the process of sports, or are used in combination with protective equipment, so that the use sense is heavy.
Current bandage development is largely around base fabric improvements, including the use of self-adhesive tape, stretch base fabrics, and the like. However, after treatment of a wound, direct contact between the bandage and the skin wound, often with exudates around the wound, and often poor breathability of the bandage, bacterial infection is likely to occur. Brings great pain to the wound and is not beneficial to the healing of the wound. The existing bandage using the hot melt adhesive coating cannot have a substantial transdermal drug delivery function, the colloid layout has salt resistance, or some hydrogel bandage products have a complicated structure due to the defect that hydrogel is easy to penetrate through cloth, the use feeling is heavy, the skin-sticking feeling is poor, the product is not light and thin, and the product is easy to fall off after sweating during sports.
Disclosure of Invention
Aiming at the defects in the prior art, the invention aims to provide a hydrogel elastic patch and a preparation method thereof.
The purpose of the invention is realized by the following technical scheme:
the invention provides a hydrogel elastic patch, which comprises an elastic material layer, a high polymer hydrogel layer with a slow release function and a release covering layer which are sequentially arranged;
the elastic material layer is compounded with hydrophobic auxiliary agent, or the elastic material layer is compounded with waterproof material, or the elastic material layer is provided with an air layer structure.
Preferably, the polymer hydrogel with the slow release function comprises the following components in percentage by mass:
0.01 to 15 percent of active medicine component, 0.01 to 15 percent of ion inhibitor, 0.01 to 1 percent of cross-linking agent, 0.1 to 10 percent of macromolecular resin, 10 to 35 percent of solvent, 0.1 to 15 percent of skin feel conditioning agent, 10 to 50 percent of deionized water, 0.1 to 3 percent of appearance conditioning agent, 0.01 to 1 percent of cross-linking conditioning agent, 0.01 to 1 percent of preservative and 0.01 to 5 percent of transdermal absorption penetration enhancer.
Preferably, the polymer hydrogel comprises the following components in percentage by mass:
1 to 10 percent of active ingredients, 3 to 10 percent of ion inhibitors, 0.1 to 0.5 percent of cross-linking agents, 5 to 10 percent of macromolecular resins, 20 to 35 percent of solvents, 1 to 5 percent of skin feel conditioning agents, 30 to 55 percent of deionized water, 0.1 to 1 percent of appearance conditioning agents, 0.1 to 1 percent of cross-linking conditioning agents, 0.1 to 0.5 percent of preservatives and 1 to 5 percent of transdermal absorption penetration enhancers.
More preferably, the polymer hydrogel comprises the following components in percentage by mass:
4 to 6 percent of active ingredients, 5 percent of ion inhibitors, 0.1 to 0.2 percent of cross-linking agents, 8 to 9.5 percent of macromolecular resins, 30 to 33 percent of solvents, 0.1 percent of skin feel conditioning agents, 40.9 to 52.04 percent of deionized water, 0.05 to 0.1 percent of appearance conditioning agents, 0.2 percent of cross-linking conditioning agents, 0.1 percent of preservatives and 0.5 percent of transdermal absorption penetration enhancers.
Preferably, the active ingredients comprise any one or more of medicinal ingredients, traditional Chinese medicine powder or extract, amino acids and plant extracts; for example, the pharmaceutical composition can be selected from analgesic components such as glucosamine, capsicum extract, camphor, menthol, methyl salicylate, lidocaine hydrochloride, etc., and can also be selected from anti-inflammatory analgesic components such as aspirin, analgin, acetaminophen, indomethacin, piroxicam, ketorolac, cortisone, hydrocortisone, dexamethasone, glycyrrhetinic acid, felbinac, loxoprofen, etc.; the Chinese medicinal powder or extractive solution can be selected from Borneolum Syntheticum, Aloe, flos Camelliae Japonicae, Olibanum resin, flos Caraganae Sinicae, radix Angelicae sinensis, semen Cassiae, herba Sidae Rhombifoliae, purple coneflower, and juniper fruit; the amino acid can be selected from glycine, serine, L-tryptophan, arginine, ornithine, 5-hydroxytryptophan, L-theanine, and theanine; the plant extract can be selected from plant extracts of sleep-aiding components such as valerian extract, passion flower extract, lemon balm leaf, chamomile extract, lavender extract, chamomile extract, balm extract, sour cherry extract, garlic extract, spearmint extract and the like, and can also be selected from plant extracts with the functions of refreshing and restoring consciousness such as wintergreen oil, angelica dahurica oil, angelica oil, cinnamon oil, eucalyptus oil, peppermint oil, borneol, patchouli oil and the like;
the ionic inhibitor comprises at least one of polyvinylpyrrolidone and a nonionic ionic inhibitor of polyvinyl alcohol;
the cross-linking agent is aluminum glycollate or aluminum hydroxide.
Preferably, the polymer resin is at least one of polyacrylic acid and sodium polyacrylate;
the solvent comprises at least one of glycerol, propylene glycol, mineral oil and polyoxyethylene sorbitan monooleate;
the skin feeling regulator is at least one of kaolin and sodium carboxymethyl cellulose;
the appearance regulator is titanium dioxide.
More preferably, the skin feel modifier is kaolin, which is an oil-absorbing inorganic powder that can modify the oil components secreted on the skin during exercise.
Preferably, the crosslinking regulator is at least one of tartaric acid, citric acid, EDTA-2Na, EDTA-4Na, malic acid and lactic acid;
the preservative is at least one of benzalkonium chloride, methyl paraben, propyl paraben and phenoxyethanol;
the transdermal absorption penetration enhancer is at least one of isopropyl myristate, dimethyl sulfoxide and azone.
Preferably, the preparation method of the polymer hydrogel with the slow release function comprises the following steps:
s1, mixing the sodium polyacrylate, the cross-linking agent, the cross-linking regulator and the appearance regulator with part of the solvent, stirring for 8-15 minutes at normal temperature, and uniformly dispersing to form phase A;
s2, adding the active pharmaceutical ingredients into partial solvent to be dissolved completely into a B phase at normal temperature;
s3, stirring the ionic inhibitor, the skin feel regulator, the transdermal absorption enhancer and the preservative for 15-20 minutes at normal temperature to form a mixed solution which is a phase C;
and S4, emulsifying the phase B and the phase C in a homogenizing emulsifying machine, pouring the emulsified liquid into a vacuum stirring kettle, mixing the phase A into the vacuum stirring kettle, and stirring to obtain the polymer hydrogel with the slow release function.
Preferably, in step S4, the rotation speed of emulsification is 4000r/min, and the emulsification time is 10-15 minutes; the stirring speed is 40-60r/min, and the stirring time is 10-15 minutes.
The hydrophobic auxiliary agent is at least one selected from a polyacrylic fluoroalkyl ester copolymer, organic silicon, a fluorocarbon polymer, a long-chain alkyl ester and a copolymer thereof.
Preferably, the preparation method of the composite hydrophobic auxiliary agent on the elastic material layer is as follows:
mixing the hydrophobic auxiliary agent and water according to the proportion of 6:94-12:88 to obtain a mixed solution, dyeing and fixing the elastic material, immersing the elastic material in the mixed solution for 5 minutes after finishing, pre-drying the elastic material for 2 minutes at the temperature of 120-140 ℃, and then sequentially drying the elastic material for 1 minute at the temperature of 150-155 ℃, 2 minutes at the temperature of 160-165 ℃ and 5 minutes at the temperature of 180-190 ℃ to obtain the elastic material layer of the composite hydrophobic auxiliary agent.
Preferably, the release covering layer comprises covering layers made of various materials and having a release effect, and is specifically selected from any one of silicone oil paper, a pearlized film, a PP release film and a PET release film.
The invention also provides a preparation method of the hydrogel elastic patch, which comprises the following steps: coating a macromolecule hydrogel layer with a slow release function on the elastic material layer, then covering a release covering layer, shearing, curing and packaging to obtain the product.
Compared with the prior art, the invention has the following beneficial effects:
1. the hydrogel elastic patch prepared by the invention is suitable for use during sports and is not easy to fall off; and the adopted elastic material has good air permeability and elastic deformation force effect, is particularly suitable for elbow joints and can be well pasted.
2. The existing elastic cloth is easy to pull due to large elasticity and has larger gaps, and the colloid is easy to flow out from the gaps of the elastic cloth due to fluidity when hydrogel is coated; the invention solves the risk of easy cloth penetration of the combination of the elastic cloth and the hydrogel by performing hydrophobic treatment on the elastic material layer or compounding the elastic material with the TPU, and simultaneously reserves the advantage of good air permeability of the elastic cloth.
3. The hydrogel layer adopted by the invention is formed by the way that sodium polyacrylate exists in a hydrophilic matrix in a cross-linked state, the formed polymer skeleton embeds active ingredients, and the colloid is compounded with a nonionic water-based ion inhibitor to improve the salt resistance of the colloid.
Drawings
Other features, objects and advantages of the invention will become more apparent upon reading of the detailed description of non-limiting embodiments with reference to the following drawings:
fig. 1 is a structural diagram of a hydrogel elastic patch, wherein, 1 is a release covering layer, 2 is a macromolecule hydrogel layer with a slow release function, and 3 is an elastic material layer.
Detailed Description
The present invention will be described in detail with reference to specific examples. The following examples will assist those skilled in the art in further understanding the invention, but are not intended to limit the invention in any way. It should be noted that variations and modifications can be made by persons skilled in the art without departing from the spirit of the invention. All falling within the scope of the present invention.
Example 1
The embodiment provides a hydrogel elastic patch, as shown in fig. 1, which includes a release cover layer 1, a polymer hydrogel layer 2 with a slow release function, and an elastic material layer 3, which are sequentially disposed. The elastic material layer 3 is elastic cloth compounded with hydrophobic additives, and the release covering layer 1 is a pearlized film.
The polymer hydrogel layer with the slow release function comprises the following components in percentage by mass: 4% lidocaine (active pharmaceutical ingredient), 5% polyvinylpyrrolidone (ion inhibitor), 0.1% aluminum glycollate (cross-linking agent), 5% sodium polyacrylate (polymer resin), polyacrylic acid 3% (polymer resin), 24% glycerol (solvent), 5% propylene glycol (solvent), 1% polyoxyethylene sorbitan monooleate (solvent), 0.1% kaolin (skin feel modifier), 0.05% titanium dioxide (appearance modifier), 0.1% tartaric acid (cross-linking modifier), 0.1% EDTA-2Na (cross-linking modifier), 0.1% phenoxyethanol (preservative), 0.5% dimethyl sulfoxide (transdermal absorption enhancer), 51.95% deionized water.
The preparation method of the elastic cloth compounded with the hydrophobic auxiliary agent comprises the following steps: mixing a polyfluoroalkyl acrylate copolymer (a hydrophobic auxiliary agent) with water according to the proportion of 6:94 to form a mixed solution, dyeing and fixing the elastic material, immersing the elastic material into the mixed solution for 5 minutes after finishing, then pre-drying the elastic material for 2 minutes at the temperature of 120-155 ℃, then drying the elastic material for 1 minute at the temperature of 150-155 ℃, drying the elastic material for 2 minutes at the temperature of 160-165 ℃ and drying the elastic material for 5 minutes at the temperature of 180-190 ℃ in sequence to obtain the modified polyfluoroalkyl acrylate. The hydrophobic grade of the elastic cloth can reach more than 5 grade according to the test method in AATCC-127-.
The preparation method of the hydrogel elastic patch in this example is as follows:
(1) stirring sodium polyacrylate, dihydroxyaluminum glycolate, kaolin, EDTA-2Na, tartaric acid and glycerol at normal temperature for 10 minutes to obtain phase A;
(2) adding lidocaine into propylene glycol and polyoxyethylene sorbitan monooleate, and dissolving at normal temperature to obtain phase B;
(3) and stirring polyvinylpyrrolidone, titanium dioxide, dimethyl sulfoxide and phenoxyethanol in deionized water at normal temperature for 15-20 minutes to form a mixed solution which is a phase C.
(4) And emulsifying the phase B and the phase C in a homogenizing emulsifying machine for 10-15 minutes at the rotation speed of 4000r/min, pouring the mixed liquid into a vacuum stirring kettle, mixing the phase A with the mixed liquid, and stirring for 10-15 minutes at the stirring speed of 40-60r/min to form the polymer hydrogel with the slow release function.
(5) Coating the elastic cloth compounded with the hydrophobic auxiliary agent with polymer hydrogel with a slow release function, then covering the elastic cloth with a pearlized film, shearing, curing and packaging to obtain the water-based coating.
The hydrogel elastic patch prepared by the invention does not permeate hydrogel on the elastic cloth due to the hydrophobic treatment of the elastic cloth.
Example 2
The embodiment provides a hydrogel elastic patch, as shown in fig. 1, which includes a release cover layer 1, a polymer hydrogel layer 2 with a slow release function, and an elastic material layer 3, which are sequentially disposed. The elastic material layer 3 is elastic cloth compounded with hydrophobic additives, and the release covering layer 1 is a pearlized film.
The polymer hydrogel layer with the slow release function comprises the following components in percentage by mass: 5% menthol (active ingredient), 5% polyvinylpyrrolidone (ion inhibitor), 0.1% aluminum glycollate (cross-linking agent), 5.5% sodium polyacrylate (polymer), 3.5% polyacrylic acid (polymer), 23% glycerol (solvent), 7% propylene glycol (solvent), 1% polyoxyethylene sorbitan monooleate (solvent), 0.1% sodium carboxymethylcellulose (skin feel modifier), 0.1% titanium dioxide (appearance modifier), 0.1% tartaric acid (cross-linking modifier), 0.1% EDTA-2Na (cross-linking modifier), 0.1% benzalkonium chloride (preservative), 0.5% isopropyl myristate (transdermal absorption enhancer), 48.9% deionized water.
The preparation method of the elastic cloth compounded with the hydrophobic auxiliary agent comprises the following steps: mixing a polyfluoroalkyl acrylate copolymer (a hydrophobic auxiliary agent) with water according to the proportion of 8:92 to form a mixed solution, dyeing and fixing the elastic material, immersing the elastic material into the mixed solution for 5 minutes after finishing, then pre-drying the elastic material for 2 minutes at the temperature of 120-155 ℃, then drying the elastic material for 1 minute at the temperature of 150-155 ℃, drying the elastic material for 2 minutes at the temperature of 160-165 ℃ and drying the elastic material for 5 minutes at the temperature of 180-190 ℃ in sequence to obtain the modified polyfluoroalkyl acrylate. The hydrophobic grade of the elastic cloth can reach more than 5 grade according to the test method in AATCC-127-.
The preparation method of the hydrogel elastic patch in this example is as follows:
(1) stirring sodium polyacrylate, aluminium glycollate, sodium carboxymethylcellulose, EDTA-2Na, tartaric acid and glycerol at normal temperature for 10 min to obtain phase A;
(2) adding menthol into propylene glycol and polyoxyethylene sorbitan monooleate, and dissolving at normal temperature to obtain phase B;
(3) stirring polyvinylpyrrolidone, titanium dioxide, isopropyl myristate and phenoxyethanol in deionized water at normal temperature for 15-20 minutes to form a mixed solution as a C phase.
(4) Emulsifying the phase B and the phase C in a homogenizing emulsifying machine for 10-15 minutes at the rotation speed of 4000r/min, pouring the mixed liquid into a vacuum stirring kettle, mixing the phase A with the mixed liquid, and stirring for 10-15 minutes at the stirring speed of 40-60r/min to form the hydrogel paste embedding the active ingredients.
(5) Coating the elastic cloth compounded with the hydrophobic auxiliary agent with polymer hydrogel with a slow release function, then covering the elastic cloth with a pearlized film, shearing, curing and packaging to obtain the water-based coating.
The hydrogel elastic patch prepared by the invention does not permeate hydrogel on the elastic cloth due to the hydrophobic treatment of the elastic cloth.
Example 3
The embodiment provides a hydrogel elastic patch, as shown in fig. 1, which includes a release cover layer 1, a polymer hydrogel layer 2 with a slow release function, and an elastic material layer 3, which are sequentially disposed. The elastic material layer 3 is elastic cloth compounded with hydrophobic auxiliary agents, and the release covering layer 1 is a pp release film.
The polymer hydrogel layer with the slow release function comprises the following components in percentage by mass: 5% menthol (active pharmaceutical ingredient), 5% polyvinylpyrrolidone (ion inhibitor), 0.2% aluminium hydroxide (cross-linking agent), 3.5% sodium polyacrylate (macromolecule), 6% polyacrylic acid (macromolecule), 25% glycerol (solvent), 7% propylene glycol (solvent), 1% polyoxyethylene sorbitan monooleate (solvent), 0.1% sodium carboxymethylcellulose (skin feel modifier), 0.1% titanium dioxide (appearance modifier), 0.1% tartaric acid (cross-linking modifier), 0.1% EDTA-2Na (cross-linking modifier), 0.1% methyl paraben (preservative), 0.1% propyl paraben (preservative), 0.5% isopropyl myristate (transdermal absorption enhancer), 46.2% deionized water.
The preparation method of the elastic cloth compounded with the hydrophobic auxiliary agent comprises the following steps: mixing a polyfluoroalkyl acrylate copolymer (a hydrophobic auxiliary agent) with water according to a ratio of 9:91 to form a mixed solution, dyeing and fixing the elastic material, immersing the elastic material into the mixed solution for 5 minutes after finishing, then pre-drying the elastic material at the temperature of 120-155 ℃ for 2 minutes, and then sequentially drying the elastic material at the temperature of 150-155 ℃ for 1 minute, at the temperature of 160-165 ℃ for 2 minutes, and at the temperature of 180-190 ℃ for 5 minutes to obtain the modified polyfluoroalkyl acrylate/hydrophobic auxiliary agent. The hydrophobic grade of the elastic cloth can reach more than 5 grade according to the test method in AATCC-127-.
The preparation method of the hydrogel elastic patch comprises the following steps:
(1) stirring sodium polyacrylate, aluminum hydroxide, sodium carboxymethylcellulose, EDTA-2Na, tartaric acid and glycerol at normal temperature for 10 minutes to obtain phase A;
(2) adding menthol into propylene glycol and polyoxyethylene sorbitan monooleate, and dissolving at normal temperature to obtain phase B;
(3) and stirring polyvinylpyrrolidone, titanium dioxide, isopropyl myristate, methyl hydroxybenzoate and propyl hydroxybenzoate in deionized water at normal temperature for 15-20 min to obtain a mixed solution as phase C.
(4) Emulsifying the phase B and the phase C in a homogenizing emulsifying machine for 10-15 minutes at the rotation speed of 4000r/min, pouring the mixed liquid into a vacuum stirring kettle, mixing the phase A with the mixed liquid, and stirring for 10-15 minutes at the stirring speed of 40-60r/min to form the hydrogel paste embedding the active ingredients.
(5) And (3) coating the macromolecular hydrogel with the slow release function on the elastic cloth of the composite hydrophobic auxiliary agent, then covering a pp release film, shearing, curing and packaging to obtain the composite hydrophobic auxiliary agent.
The hydrogel elastic patch prepared by the invention does not permeate hydrogel on the elastic cloth due to the hydrophobic treatment of the elastic cloth.
Example 4
The invention provides a hydrogel elastic patch which is basically the same as the structure of the embodiment 1, and is different from the embodiment in that: in the composition of each component of the polymer hydrogel with the sustained-release function, polyvinyl alcohol is used to replace polyvinylpyrrolidone in this example.
The hydrogels prepared in examples 1-4 above have good skin-friendly and skin-permeable properties, long drug release time, good bio-adhesion to skin, repeated release, no residual gel, and good adhesion even if a user sweats, especially when used during exercise.
Example 5
The invention provides a hydrogel elastic patch which is basically the same as the structure of the embodiment 1, and is different from the embodiment in that: in the composition of each component of the polymer hydrogel with the slow release function, polyvinyl alcohol is used to replace polyvinylpyrrolidone in this embodiment, and the content of polyvinyl alcohol is 3%, and the content of deionized water is 53.95%.
Example 6
The invention provides a hydrogel elastic patch which is basically the same as the structure of the embodiment 1, and is different from the embodiment in that: in the composition of each component of the polymer hydrogel with the slow release function, polyvinyl alcohol is used to replace polyvinylpyrrolidone in this embodiment, and the content of polyvinyl alcohol is 8%, and the content of deionized water is 48.95%.
Example 7
The invention provides a hydrogel elastic patch which is basically the same as the structure of the embodiment 1, and is different from the embodiment in that: in the components of the polymer hydrogel with the slow release function, polyvinyl alcohol is used to replace polyvinylpyrrolidone in this embodiment, and the content of polyvinyl alcohol is 10%, and the content of deionized water is 46.95%.
Comparative example 1
This comparative example provides a hydrogel elastic patch having substantially the same structural composition as example 1, except that: the polymer hydrogel layer with the slow release function of the comparative example is not added with a cross-linking agent, and the content of deionized water is 52.14%.
The preparation method of the polymer hydrogel is the same as that of example 1.
The gel prepared by the hydrogel elastic patch prepared by the invention has no cross-linking agent, so that the cross-linking process is too fast or too slow, the cross-linking degree of the gel is not uniform, and the gel cannot be coated.
Comparative example 2
This comparative example provides a hydrogel elastic patch having substantially the same structural composition as example 1, except that: the polymer hydrogel layer with the slow release function of the comparative example is not added with an ion inhibitor, and the content of deionized water is 56.95%.
The preparation method of the polymer hydrogel is the same as that of example 1.
The hydrogel elastic patch prepared by the invention is applied for a long time, and is easy to lose stickiness and fall off due to human body sweating.
Comparative example 3
This comparative example provides a hydrogel elastic patch having substantially the same structural composition as example 1, except that: the elastic material layer used in this comparative example was a conventional elastic cloth (i.e., an elastic cloth not compounded with a hydrophobic auxiliary).
The hydrogel elastic patch prepared by the invention has the advantage that hydrogel permeates on the elastic cloth because the elastic cloth is not subjected to hydrophobic treatment.
The hydrogel elastic patches prepared in example 1 and comparative example 2 were cut into 3 pieces of samples with a length of 30cm × 2.5cm, and about 2 g of artificial sweat was uniformly applied to the surface of each piece of hydrogel elastic patch and pretreated at 25 ± 2 ℃ and 60% RH for 2 hours, according to the test method of GB/T2792-:
TABLE 1
Figure BDA0002974781010000091
From the above test results, comparative example 2 has a significantly reduced adhesion effect under the condition of immersion in artificial sweat, since no ion inhibitor is added.
The hydrogel elastic patches prepared in examples 2-6 were cut into 3 pieces of strip samples of 30cm × 2.5cm according to the aforementioned method, about 2 g of artificial sweat was uniformly coated on the surface of each piece of hydrogel elastic patch and pretreated for 2 hours at 25 ± 2 ℃ and 60% RH according to the test method of GB/T2792-:
TABLE 2
Figure BDA0002974781010000092
The hydrogel can be coated on a composite waterproof composite material or an air layer material with a certain structure, so that the problem of colloid seepage is solved, the shape of the product is not limited in the attached drawing, the size of the product can be cut at will, the product comprises a product with a hollow-out surface, and the air permeability is improved.
The embodiments described above are described to facilitate an understanding and use of the invention by those skilled in the art. It will be readily apparent to those skilled in the art that various modifications to these embodiments may be made, and the generic principles described herein may be applied to other embodiments without the use of the inventive faculty. Therefore, the present invention is not limited to the above embodiments, and those skilled in the art should make improvements and modifications within the scope of the present invention based on the disclosure of the present invention.

Claims (10)

1. The hydrogel elastic patch is characterized by comprising an elastic material layer, a high polymer hydrogel layer with a slow release function and a release covering layer which are sequentially arranged;
the elastic material layer is an elastic material layer compounded with a hydrophobic auxiliary agent, or a material layer formed by compounding an elastic material and a waterproof material, or an elastic material layer with an air layer structure.
2. The hydrogel elastic patch as claimed in claim 1, wherein the polymer hydrogel layer with slow release function comprises the following components by mass percent:
0.01 to 15 percent of active ingredients, 0.01 to 15 percent of ion inhibitors, 0.01 to 1 percent of cross-linking agents, 0.1 to 10 percent of macromolecular resin, 10 to 35 percent of solvents, 0.1 to 15 percent of skin feel conditioning agents, 10 to 50 percent of deionized water, 0.1 to 3 percent of appearance conditioning agents, 0.01 to 1 percent of cross-linking conditioning agents, 0.01 to 1 percent of preservatives and 0.01 to 5 percent of transdermal absorption penetration enhancers.
3. The hydrogel elastic patch as claimed in claim 1, wherein the active ingredient comprises any one or more of a pharmaceutical ingredient, a powder or an extract of a traditional Chinese medicine, an amino acid, and a plant extract;
the ionic inhibitor comprises at least one of polyvinylpyrrolidone and a nonionic ionic inhibitor of polyvinyl alcohol;
the cross-linking agent is aluminum glycollate or aluminum hydroxide.
4. The hydrogel elastic patch as claimed in claim 1, wherein the polymeric resin is at least one of polyacrylic acid and sodium polyacrylate;
the solvent comprises at least one of glycerol, propylene glycol, mineral oil and polyoxyethylene sorbitan monooleate;
the skin feeling regulator is at least one of kaolin and sodium carboxymethyl cellulose;
the appearance regulator is titanium dioxide.
5. The hydrogel elastic patch according to claim 1, wherein the crosslinking modifier is tartaric acid, citric acid, EDTA-2Na, EDTA-4Na, malic acid, lactic acid;
the preservative is at least one of benzalkonium chloride, methyl paraben, propyl paraben and phenoxyethanol;
the transdermal absorption penetration enhancer is at least one of isopropyl myristate, dimethyl sulfoxide and azone.
6. The hydrogel elastic patch as claimed in claim 1, wherein the method for preparing the polymer hydrogel with sustained release function comprises the following steps:
s1, mixing the sodium polyacrylate, the cross-linking agent, the cross-linking regulator and the appearance regulator with part of the solvent, stirring for 8-15 minutes at normal temperature, and uniformly dispersing to form phase A;
s2, adding the active pharmaceutical ingredients into partial solvent to be dissolved completely into a B phase at normal temperature;
s3, stirring the ionic inhibitor, the skin feel regulator, the transdermal absorption enhancer and the preservative for 15-20 minutes at normal temperature to form a mixed solution which is a phase C;
and S4, emulsifying the phase B and the phase C in a homogenizing emulsifying machine, pouring the emulsified liquid into a vacuum stirring kettle, mixing the phase A into the vacuum stirring kettle, and stirring to obtain the polymer hydrogel with the slow release function.
7. The method for preparing polymer hydrogel with sustained-release function according to claim 6, wherein in step S4, the rotation speed of emulsification is 4000r/min, and the emulsification time is 10-15 minutes; the stirring speed is 40-60r/min, and the stirring time is 10-15 minutes.
8. The hydrogel elastic patch as claimed in claim 1, wherein the hydrophobic auxiliary agent is at least one selected from the group consisting of a poly (fluoroalkyl acrylate) copolymer, silicone, fluorocarbon polymer, long-chain alkyl ester, and a copolymer thereof;
the waterproof material is made of thermoplastic elastomer or rubber.
9. The hydrogel elastic patch as claimed in claim 1 or 8, wherein the elastic material layer compounded with the hydrophobic auxiliary agent is prepared by the following method:
mixing the hydrophobic auxiliary agent and water according to the proportion of 6:94-12:88 to obtain a mixed solution, dyeing and fixing the elastic material, immersing the elastic material in the mixed solution for 5 minutes after finishing, pre-drying the elastic material for 2 minutes at the temperature of 120-140 ℃, and then sequentially drying the elastic material for 1 minute at the temperature of 150-155 ℃, 2 minutes at the temperature of 160-165 ℃ and 5 minutes at the temperature of 180-190 ℃ to obtain the elastic material layer of the composite hydrophobic auxiliary agent.
10. A method of making a hydrogel elastic patch according to claim 1 comprising the steps of: coating a macromolecule hydrogel layer with a slow release function on the elastic material layer, then covering a release covering layer, shearing, curing and packaging to obtain the product.
CN202110271604.XA 2021-03-12 2021-03-12 Hydrogel elastic patch and preparation method thereof Pending CN112870427A (en)

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CN1857261A (en) * 2006-03-30 2006-11-08 华中科技大学 Aquogel type thiamazole plaster preparation
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