WO2022188861A1 - 一种具有缓释功能的高分子水凝胶及其制备方法和应用 - Google Patents
一种具有缓释功能的高分子水凝胶及其制备方法和应用 Download PDFInfo
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- WO2022188861A1 WO2022188861A1 PCT/CN2022/080351 CN2022080351W WO2022188861A1 WO 2022188861 A1 WO2022188861 A1 WO 2022188861A1 CN 2022080351 W CN2022080351 W CN 2022080351W WO 2022188861 A1 WO2022188861 A1 WO 2022188861A1
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- hydrogel
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- 229920001477 hydrophilic polymer Polymers 0.000 description 1
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- 229960004752 ketorolac Drugs 0.000 description 1
- OZWKMVRBQXNZKK-UHFFFAOYSA-N ketorolac Chemical compound OC(=O)C1CCN2C1=CC=C2C(=O)C1=CC=CC=C1 OZWKMVRBQXNZKK-UHFFFAOYSA-N 0.000 description 1
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- BAZQYVYVKYOAGO-UHFFFAOYSA-M loxoprofen sodium hydrate Chemical compound O.O.[Na+].C1=CC(C(C([O-])=O)C)=CC=C1CC1C(=O)CCC1 BAZQYVYVKYOAGO-UHFFFAOYSA-M 0.000 description 1
- 239000011159 matrix material Substances 0.000 description 1
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- LDCYZAJDBXYCGN-UHFFFAOYSA-N oxitriptan Natural products C1=C(O)C=C2C(CC(N)C(O)=O)=CNC2=C1 LDCYZAJDBXYCGN-UHFFFAOYSA-N 0.000 description 1
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- QYSPLQLAKJAUJT-UHFFFAOYSA-N piroxicam Chemical compound OC=1C2=CC=CC=C2S(=O)(=O)N(C)C=1C(=O)NC1=CC=CC=N1 QYSPLQLAKJAUJT-UHFFFAOYSA-N 0.000 description 1
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- IFGCUJZIWBUILZ-UHFFFAOYSA-N sodium 2-[[2-[[hydroxy-(3,4,5-trihydroxy-6-methyloxan-2-yl)oxyphosphoryl]amino]-4-methylpentanoyl]amino]-3-(1H-indol-3-yl)propanoic acid Chemical compound [Na+].C=1NC2=CC=CC=C2C=1CC(C(O)=O)NC(=O)C(CC(C)C)NP(O)(=O)OC1OC(C)C(O)C(O)C1O IFGCUJZIWBUILZ-UHFFFAOYSA-N 0.000 description 1
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Images
Classifications
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- A61L26/0061—Use of materials characterised by their function or physical properties
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- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
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- A61L15/24—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof
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- A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
- A61L2300/216—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials with other specific functional groups, e.g. aldehydes, ketones, phenols, quaternary phosphonium groups
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- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
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- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/80—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special chemical form
- A61L2300/802—Additives, excipients, e.g. cyclodextrins, fatty acids, surfactants
Definitions
- the invention relates to the technical field of medicine and medical equipment, and in particular to a polymer hydrogel with sustained release function and a preparation method and application thereof.
- bandages mainly revolves around the improvement of base fabrics, including the use of self-adhesive tapes, elastic base fabrics and so on.
- base fabrics including the use of self-adhesive tapes, elastic base fabrics and so on.
- the bandage usually has poor breathability and is prone to bacterial infection. It brings great pain to the injured and is not conducive to the healing of the wound.
- the existing bandages using hot melt adhesive coating cannot have the function of substantial transdermal drug delivery, and the colloid layout is salt-resistant, or some hydrogel bandage products are designed due to the drawbacks of hydrogel permeable cloth.
- the structure is very complicated, the feeling of use is cumbersome, the feeling of sticking to the skin is not good, it is not light and thin, and it is easy to fall off when sweating during exercise.
- the purpose of the present invention is to provide a polymer hydrogel with slow release function and its preparation method and application.
- the present invention provides a polymer hydrogel with slow release function, comprising the following components by mass percentage:
- 0.01%-15% active pharmaceutical ingredient 0.01%-15% ion inhibitor, 0.01%-1% cross-linking agent, 0.1%-10% polymer resin, 10%-35% solvent, 0.1%-15% peptide Sensation modifier, 10%-55% deionized water, 0.1%-3% appearance modifier, 0.01-1% cross-linking modifier, 0.01%-1% preservative, 0.01%-5% transdermal absorption enhancer agent.
- the polymer hydrogel comprises the following components by mass percentage:
- 1%-10% active ingredient 3%-10% ion inhibitor, 0.1%-0.5% cross-linking agent, 5%-10% polymer resin, 20%-35% solvent, 1%-5% skin feel Conditioner, 30%-55% deionized water, 0.1%-1% appearance conditioner, 0.1%-1% crosslinking conditioner, 0.1-0.5% preservative, 1%-5% transdermal absorption enhancer .
- the polymer hydrogel includes the following components by mass percentage:
- the active ingredients include any one or more of pharmaceutical ingredients, traditional Chinese medicine powders or extracts, amino acids, and plant extracts.
- the pharmaceutical ingredients can be selected from glucosamine, capsicum extract, camphor, menthol, methyl salicylate, lidocaine, lidocaine hydrochloride and other analgesic ingredients, and can also be selected from aspirin, analgin, Paracetamol, indomethacin, piroxicam, ketorolac, cortisone, hydrocortisone, dexamethasone, glycyrrhetinic acid, felbinac, loxoprofen and other anti-inflammatory and analgesic ingredients;
- the traditional Chinese medicine powder or extract can be selected from borneol, aloe vera, camellia, frankincense resin, arnica montana flower, angelica, cassia, calendula flower, echinacea, juniper fruit and other traditional Chinese medicine powder or extract; the amino
- the ion inhibitor includes at least one of polyvinylpyrrolidone, a non-ionic ion inhibitor of polyvinyl alcohol.
- the cross-linking agent is aluminum carboxylate or aluminum hydroxide.
- the polymer resin is at least one of polyacrylic acid and sodium polyacrylate.
- the solvent includes at least one of glycerol, propylene glycol, mineral oil, and polyoxyethylene sorbitan monooleate.
- the skin feel modifier is at least one of kaolin and sodium carboxymethyl cellulose;
- the appearance modifier is titanium dioxide.
- the skin feel modifier is kaolin clay, which is an oil-absorbing inorganic powder, which can regulate the oil components secreted on the skin during exercise.
- the crosslinking regulator is at least one of tartaric acid, citric acid, EDTA-2Na, EDTA-4Na, malic acid, and lactic acid;
- Described preservative is at least one of benzalkonium chloride, methylparaben, propylparaben, phenoxyethanol;
- the transdermal absorption enhancer is at least one of isopropyl myristate, dimethyl sulfoxide and azone.
- the present invention also provides a preparation method of the polymer hydrogel with slow-release function, comprising the following steps:
- the rotational speed of the emulsification is 4000 r/min, and the emulsification time is 10-15 minutes; the stirring speed is 40-60 r/min, and the stirring time is 10-15 minutes.
- the present invention also provides a hydrogel elastic patch, comprising an elastic material layer, a polymer hydrogel layer with slow release function and a release covering layer arranged in sequence;
- the elastic material layer is compounded with a hydrophobic auxiliary agent, or the elastic material layer is compounded with a waterproof material, or an elastic material layer with an air layer structure;
- the polymer hydrogel layer with sustained-release function includes the above-mentioned polymer hydrogel.
- the release covering layer includes covering layers of various materials with release effect, and is specifically selected from any one of silicone oil paper, pearl film, PP release film, and PET release film.
- the hydrophobic auxiliary agent is selected from at least one of polyfluoroalkyl acrylate copolymers, silicones, fluorocarbon polymers, long-chain alkane esters and copolymers thereof;
- the material of the waterproof material is thermoplastic elastomer or rubber.
- the preparation method of the elastic material layer composited with the hydrophobic auxiliary agent on the elastic material layer is as follows:
- the hydrophobic auxiliary agent and water are mixed in a ratio of 6:94-12:88, and the elastic material is dyed and fixed. After finishing, immersed in the mixed solution for 5 minutes, pre-bake at 120-140 ° C for 2 minutes, and then sequentially After drying at 150°C-155°C for 1 minute, at 160°C-165°C for 2 minutes, and at 180-190°C for 5 minutes, the elastic material layer of the composite hydrophobic auxiliary agent is obtained.
- the invention also provides a preparation method of a hydrogel elastic patch, comprising the following steps: coating a polymer hydrogel layer with slow release function on the elastic material layer, then covering the release covering layer, shearing, Cured, packaged, and ready to go.
- the present invention has the following beneficial effects:
- the hydrogel used in the present invention is that sodium polyacrylate exists in a hydrophilic matrix in a cross-linked state, the formed polymer skeleton embeds the active ingredient, and the colloid is compounded using a non-ionic aqueous ion inhibitor, Improve the salt resistance of the colloid, the hydrophilic polymer hydrogel has good skin affinity and skin permeability, long-lasting drug release time, good bio-adhesion to the skin, and can be peeled off repeatedly without residual colloid , especially when the user uses it during exercise, even if the human body sweats, it still maintains a good adhesiveness.
- the hydrogel elastic patch prepared by the present invention is suitable for use during exercise and is not easy to fall off; and the elastic material adopted has good air permeability and elastic deformation force, and is especially suitable for the elbow joint, and can be well attached.
- the existing elastic cloth is easy to be pulled due to its large elasticity and has a large gap.
- the hydrogel is coated, due to its fluidity, the colloid is easy to flow out from the gap of the elastic cloth; Treating or compounding the elastic material with TPU solves the risk of combining elastic cloth with hydrogel and easily penetrates the cloth, and at the same time retains the advantages of good air permeability of the elastic cloth.
- Fig. 1 is a structural diagram of a hydrogel elastic patch, wherein 1-a release covering layer, 2-a polymer hydrogel layer with slow release function, and 3-elastic material layer.
- This embodiment provides a polymer hydrogel with sustained-release function, comprising the following components by mass percentage: 4% lidocaine (active ingredient), 5% polyvinylpyrrolidone (ion inhibitor), 0.1% aluminum glycerol (crosslinking agent), 5% sodium polyacrylate (polymer resin), 3% polyacrylic acid (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 (crosslinking modifier), 0.1% EDTA-2Na (crosslinking regulator), 0.1% phenoxyethanol (preservative), 0.5% dimethyl sulfoxide (permeation enhancer for transdermal absorption), 51.95% deionized water.
- the preparation method of the polymer hydrogel is as follows:
- phase A (1) Sodium polyacrylate, aluminum glycerol, kaolin, EDTA-2Na, tartaric acid and glycerol are stirred for 10 minutes at normal temperature to be phase A;
- This embodiment provides a polymer hydrogel with sustained-release function, including the following components in mass percentage: 5% menthol (active ingredient), 5% polyvinylpyrrolidone (ion inhibitor), 0.1% % glycerol (crosslinking agent), 5.5% sodium polyacrylate (polymer), 3.5% polyacrylic acid (polymer), 23% glycerol (solvent), 7% propylene glycol (solvent), 1% polyoxyethylene dehydration Sorbitol monooleate (solvent), 0.1% sodium carboxymethyl cellulose (skin feel modifier), 0.1% titanium dioxide (appearance modifier), 0.1% tartaric acid (crosslinking modifier), 0.1% EDTA-2Na , (crosslinking regulator) 0.1% benzalkonium chloride (preservative), 0.5% isopropyl myristate (permeation enhancer for transdermal absorption), 48.9% deionized water.
- the preparation method of the polymer hydrogel is as follows:
- phase A (1) with sodium polyacrylate, aluminum glycerol, sodium carboxymethyl cellulose, EDTA-2Na, tartaric acid and glycerol at room temperature stirring for 10 minutes to be phase A;
- phase C (3) The polyvinylpyrrolidone, titanium dioxide, isopropyl myristate, and phenoxyethanol are stirred in deionized water at room temperature for 15-20 minutes to form a mixed solution as phase C.
- This embodiment provides a polymer hydrogel with sustained release function, including the following components in mass percentage: 5% menthol (active ingredient), 5% polyvinylpyrrolidone (ion inhibitor), 0.2% % aluminum hydroxide (crosslinking agent), 3.5% sodium polyacrylate (polymer), 6% polyacrylic acid (polymer), 25% glycerin (solvent), 7% propylene glycol (solvent), 1% polyoxyethylene dehydration Sorbitol monooleate (solvent), 0.1% sodium carboxymethyl cellulose (skin feel modifier), 0.1% titanium dioxide (appearance modifier), 0.1% tartaric acid (crosslinking modifier), 0.1% EDTA-2Na (crosslinking modifier), 0.1% methylparaben (preservative), 0.1% propylparaben (preservative), 0.5% isopropyl myristate (permeation enhancer), 46.2% Deionized water.
- the preparation method of the polymer hydrogel is as follows:
- phase A (1) with sodium polyacrylate, aluminum hydroxide, sodium carboxymethyl cellulose, EDTA-2Na, tartaric acid and glycerol at room temperature stirring for 10 minutes to be phase A;
- the present invention provides a polymer hydrogel with sustained release function, the composition of each component is basically the same as that of Example 1, the only difference is that polyvinyl alcohol is used instead of polyvinylpyrrolidone in this example.
- the hydrogels prepared in the above examples 1-4 have good skin-friendly and skin permeability, long-lasting drug release time, good bio-adhesion to the skin, can be repeatedly peeled off, and no residual colloid, especially when used. It is used during exercise, even if the human body sweats, it still maintains good adhesion.
- the present invention provides a macromolecule hydrogel with slow-release function, the composition of each component is basically the same as that in Example 1, the only difference is that in this example, polyvinyl alcohol is used instead of polyvinylpyrrolidone, and polyvinyl alcohol is used instead of polyvinylpyrrolidone.
- the alcohol content was 3% and the deionized water content was 53.95%.
- the present invention provides a macromolecule hydrogel with slow-release function, the composition of each component is basically the same as that in Example 1, the only difference is that in this example, polyvinyl alcohol is used instead of polyvinylpyrrolidone, and polyvinyl alcohol is used instead of polyvinylpyrrolidone.
- the alcohol content was 8% and the deionized water content was 48.95%.
- the present invention provides a macromolecule hydrogel with slow-release function
- the composition of each component is basically the same as that in Example 1, the only difference is that in this example, polyvinyl alcohol is used instead of polyvinylpyrrolidone, and polyvinyl alcohol is used instead of polyvinylpyrrolidone.
- the alcohol content was 10% and the deionized water content was 46.95%.
- This comparative example provides a polymer hydrogel with slow-release function
- the composition of each component is basically the same as that of Example 1, the only difference is: no cross-linking agent is added in this comparative example, and the content of deionized water was 52.14%.
- the preparation method of the polymer hydrogel is the same as that in Example 1.
- the cross-linking process occurs too fast or too slow, the degree of colloid cross-linking is uneven, and the coating cannot be carried out.
- This comparative example provides a macromolecule hydrogel with slow-release function
- the composition of each component is basically the same as that of Example 1, the only difference is that no ion inhibitor is added in this comparative example, and the content of deionized water is 56.95%.
- the preparation method of the polymer hydrogel is the same as that in Example 1.
- hydrogel pastes prepared in Example 1 and Comparative Example 2 were coated on elastic cloth, covered with a release covering layer, cut, and cured to obtain a hydrogel paste.
- the obtained hydrogel plaster is carried out effect test, and concrete test method and result are as follows:
- Example 1 Cut the gel stickers of Example 1 and Comparative Example 2 into 3 pieces of 30cm*2.5cm strip samples respectively, and apply about 2 grams of artificial sweat evenly on the surface of each piece of hydrogel sticker at 25 ⁇ 2°C, 60% Pretreatment under the condition of RH for 2 hours, according to GB/T 2792-2014 peel force test method, the test results are shown in Table 1 below:
- the gel patch of Example 2-7 was cut into 3 pieces of 30cm*2.5cm strip samples, and about 2 grams of artificial sweat were evenly applied to the surface of each hydrogel patch at 25 ⁇ 2°C, 60% RH Under the condition of pretreatment for 2 hours, according to GB/T 2792-2014 peel force test method, the test results (take the average value of 3 samples) are shown in Table 2 below:
- This embodiment provides a hydrogel elastic patch, as shown in FIG. 1 , which includes a release covering layer 1 , a polymer hydrogel layer 2 with slow-release function, and an elastic material layer 3 arranged in sequence.
- the elastic material layer 3 is an elastic cloth compounded with a hydrophobic auxiliary agent, and the release covering layer 1 is a pearlescent film.
- the polymer hydrogel layer with sustained release function includes the following components by mass percentage: 4% lidocaine (active pharmaceutical ingredient), 5% polyvinylpyrrolidone (ion inhibitor), 0.1% glycerol Aluminum (crosslinking agent), 5% sodium polyacrylate (polymer resin), 3% polyacrylic acid (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 (crosslinking modifier), 0.1% EDTA-2Na (crosslinking modifier) ), 0.1% phenoxyethanol (preservative), 0.5% dimethyl sulfoxide (transdermal absorption enhancer), 51.95% deionized water.
- the preparation method of the elastic cloth of the composite hydrophobic auxiliary agent is as follows: the polyfluoroalkyl acrylate copolymer (hydrophobic auxiliary agent) is mixed with water in a ratio of 6:94, and the elastic material is dyed and fixed. After finishing, immerse in the mixture for 5 minutes, then pre-bake at 120-140°C for 2 minutes, then bake at 150-155°C for 1 minute, bake at 160-165°C for 2 minutes, and bake at 180-190°C for 5 minutes. That's it. According to the test method in AATCC-127-1977, the hydrophobicity level of the elastic cloth can reach above 5.
- phase A (1) Sodium polyacrylate, aluminum glycerol, kaolin, EDTA-2Na, tartaric acid and glycerol are stirred for 10 minutes at normal temperature to be phase A;
- the hydrogel elastic patch prepared by the invention does not penetrate the hydrogel on the elastic cloth.
- This embodiment provides a hydrogel elastic patch, as shown in FIG. 1 , which includes a release covering layer 1 , a polymer hydrogel layer 2 with slow-release function, and an elastic material layer 3 arranged in sequence.
- the elastic material layer 3 is an elastic cloth compounded with a hydrophobic auxiliary agent, and the release covering layer 1 is a pearlescent film.
- the polymer hydrogel layer with sustained release function includes the following components by mass percentage: 5% menthol (active ingredient), 5% polyvinylpyrrolidone (ion inhibitor), 0.1% aluminum glycol ( cross-linking agent), 5.5% sodium polyacrylate (polymer), 3.5% polyacrylic acid (polymer), 23% glycerin (solvent), 7% propylene glycol (solvent), 1% polyoxyethylene sorbitan monooleic acid Ester (solvent), 0.1% sodium carboxymethyl cellulose (skin feel modifier), 0.1% titanium dioxide (appearance modifier), 0.1% tartaric acid (crosslinking modifier), 0.1% EDTA-2Na, (crosslinking modifier) agent) 0.1% benzalkonium chloride (preservative), 0.5% isopropyl myristate (transdermal absorption enhancer), 48.9% deionized water.
- the preparation method of the elastic cloth of the composite hydrophobic auxiliary agent is as follows: the polyfluoroalkyl acrylate copolymer (hydrophobic auxiliary agent) is mixed with water in a ratio of 8:92, and the elastic material is dyed and fixed. After finishing, immerse in the mixture for 5 minutes, then pre-bake at 120-140°C for 2 minutes, then bake at 150-155°C for 1 minute, bake at 160-165°C for 2 minutes, and bake at 180-190°C for 5 minutes. That's it. According to the test method in AATCC-127-1977, the hydrophobicity level of the elastic cloth can reach above 5.
- phase A (1) with sodium polyacrylate, aluminum glycerol, sodium carboxymethyl cellulose, EDTA-2Na, tartaric acid and glycerol at room temperature stirring for 10 minutes to be phase A;
- phase C (3) The polyvinylpyrrolidone, titanium dioxide, isopropyl myristate, and phenoxyethanol are stirred in deionized water at room temperature for 15-20 minutes to form a mixed solution as phase C.
- the hydrogel elastic patch prepared by the invention does not penetrate the hydrogel on the elastic cloth.
- This embodiment provides a hydrogel elastic patch, as shown in FIG. 1 , which includes a release covering layer 1 , a polymer hydrogel layer 2 with slow-release function, and an elastic material layer 3 arranged in sequence.
- the elastic material layer 3 is an elastic cloth compounded with a hydrophobic auxiliary agent, and the release covering layer 1 is a pp release film.
- the polymer hydrogel layer with sustained release function includes the following components in mass percentage: 5% menthol (active pharmaceutical ingredient), 5% polyvinylpyrrolidone (ion inhibitor), 0.2% aluminum hydroxide (crosslinking agent), 3.5% sodium polyacrylate (polymer), 6% polyacrylic acid (polymer), 25% glycerin (solvent), 7% propylene glycol (solvent), 1% polyoxyethylene sorbitan mono oil Ester (solvent), 0.1% sodium carboxymethyl cellulose (skin feel modifier), 0.1% titanium dioxide (appearance modifier), 0.1% tartaric acid (crosslinking modifier), 0.1% EDTA-2Na (crosslinking modifier) agent), 0.1% methylparaben (preservative), 0.1% propylparaben (preservative), 0.5% isopropyl myristate (permeation enhancer), 46.2% deionized water.
- the preparation method of the elastic cloth of the composite hydrophobic auxiliary agent is as follows: the polyfluoroalkyl acrylate copolymer (hydrophobic auxiliary agent) is mixed with water in a ratio of 9:91, and the elastic material is dyed and fixed. After finishing, immerse in the mixture for 5 minutes, then pre-bake at 120-140°C for 2 minutes, then bake at 150-155°C for 1 minute, bake at 160-165°C for 2 minutes, and bake at 180-190°C for 5 minutes. That's it. According to the test method in AATCC-127-1977, the hydrophobicity level of the elastic cloth can reach above 5.
- the preparation method of the hydrogel elastic patch is as follows:
- phase A (1) with sodium polyacrylate, aluminum hydroxide, sodium carboxymethyl cellulose, EDTA-2Na, tartaric acid and glycerol at room temperature stirring for 10 minutes to be phase A;
- the hydrogel elastic patch prepared by the invention does not penetrate the hydrogel on the elastic cloth.
- the present invention provides a hydrogel elastic patch, which is basically the same in structure as Example 8, except that among the components of the polymer hydrogel with slow-release function used, this example uses a polymer Vinyl alcohol replaces polyvinylpyrrolidone.
- the hydrogels prepared in the above examples 8-11 have good skin-friendly and skin permeability, long-lasting drug release time, good bio-adhesion to the skin, can be repeatedly peeled off, no residual colloid, especially when used It is used during exercise, even if the human body sweats, it still maintains good adhesion.
- the present invention provides a hydrogel elastic patch, which is basically the same in structure as Example 8, except that among the components of the polymer hydrogel with slow-release function used, this example uses a polymer Vinyl alcohol replaces polyvinylpyrrolidone, and the polyvinyl alcohol content is 3% and the deionized water content is 53.95%.
- the present invention provides a hydrogel elastic patch, which is basically the same in structure as Example 8, except that among the components of the polymer hydrogel with slow-release function used, this example uses a polymer Vinyl alcohol replaces polyvinylpyrrolidone, and the polyvinyl alcohol content is 8% and the deionized water content is 48.95%.
- the present invention provides a hydrogel elastic patch, which is basically the same in structure as Example 8, except that among the components of the polymer hydrogel with slow-release function used, this example uses a polymer Vinyl alcohol replaces polyvinylpyrrolidone, and the polyvinyl alcohol content is 10% and the deionized water content is 46.95%.
- This comparative example provides a hydrogel elastic patch, the structural composition of which is basically the same as that of Example 8, the only difference is that no cross-linking is added to the polymer hydrogel layer with slow release function of this comparative example agent, the deionized water content was 52.14%.
- the preparation method of the polymer hydrogel is the same as that of Example 8.
- the colloid prepared by the hydrogel elastic patch prepared by the present invention has no cross-linking agent, the cross-linking process occurs too fast or too slow, the degree of colloid cross-linking is uneven, and the coating cannot be carried out.
- This comparative example provides a hydrogel elastic patch, the structural composition of which is basically the same as that of Example 8, the difference is only that: the polymer hydrogel layer with slow release function of this comparative example does not add ion suppression agent, the deionized water content is 56.95%.
- the preparation method of the polymer hydrogel is the same as that of Example 8.
- the hydrogel elastic patch prepared by the invention is applied for a long time, and it is easy to lose stickiness and fall off due to the sweating of the human body.
- This comparative example provides a hydrogel elastic patch, the structural composition of which is basically the same as that of Example 8, except that the elastic material layer used in this comparative example is a conventional elastic cloth (that is, no hydrophobic auxiliary agent is compounded). elastic cloth).
- the hydrogel elastic patch prepared by the present invention has no hydrophobic treatment on the elastic cloth, and the hydrogel penetrates on the elastic cloth.
- Example 8 The hydrogel elastic patches prepared in Example 8 and Comparative Example 4 were cut into 3 pieces of 30cm*2.5cm strip samples, and about 2 grams of artificial sweat were evenly spread on the surface of each hydrogel elastic patch at 25 ⁇ 2. °C, 60%RH pretreatment for 2 hours, according to GB/T 2792-2014 peel force test method, the test results are shown in Table 3 below:
- the hydrogel elastic patch prepared in Example 9-14 was cut into 3 pieces of 30cm*2.5cm strip samples, and about 2 grams of artificial sweat was evenly spread on the surface of each hydrogel elastic patch at 25 ⁇ 2.
- the test results are shown in Table 4 below:
- the hydrogel can also be coated on the composite waterproof composite material, or on the air layer material with a certain structure, to solve the problem of colloid exudation, and the shape of the product is not limited to the drawings, and the size can be arbitrarily cut , including products with hollowed-out surfaces to increase breathability.
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Abstract
本发明提供了一种具有缓释功能的高分子水凝胶及其制备方法与应用，所述水凝胶包括以下质量百分含量的各组分：0.01％-15％的活性成分，0.01％-15％离子抑制剂，0.01％-1％交联剂，0.1％-10％高分子树脂，10％-35％溶剂，0.1％-15％肤感调节剂，10％-55％去离子水，0.1％-3％外观调节剂，0.01-1％的交联调节剂，0.01％-1％防腐剂，0.01％-5％透皮吸收促渗剂。本发明制得的高分子水凝胶具有良好的亲肤性和皮肤透过性，缓释药物时间长，与皮肤有良好的生物粘贴性，可反复揭帖，无残留胶体，特别是使用者在运动过程中使用，即使人体出汗仍然保持良好的粘贴性，具有较好的应用前景，适合推广使用。
Description
本发明涉及医药、医疗器械技术领域，具体涉及一种具有缓释功能的高分子水凝胶及其制备方法与应用。
由于人们越来越注重健康，经常运动，难免肌肉拉伤，或者运动前需要保护肌肉，但目前市面上的传统产品在运动过程中由于出汗，贴片易脱落，或者结合护具使用，使用感笨重。
目前绷带发展主要围绕基布改良，包括基布使用自粘胶带、弹力基布等等。然而在处理伤口后，绷带与皮肤伤口之间直接接触，伤口附近通常有溢出液存在，加上绷带通常透气性能差，容易发生细菌感染。给伤患带来巨大的痛苦，不利于伤口的愈合。而现有的使用热熔胶涂层的绷带无法具有实质的透皮给药的功能，且胶体布局有抗盐性，或者有些水凝胶绷带产品由于水凝胶易透布的弊端而设计的结构很复杂，使用感笨重，贴肤感不好，不轻薄，运动出汗易脱落。
发明内容
针对现有技术中的不足，本发明的目的是提供一种具有缓释功能的高分子水凝胶及其制备方法与应用。
本发明的目的是通过以下技术方案实现的：
本发明提供了一种具有缓释功能的高分子水凝胶，包括以下质量百分含量的各组分：
0.01％-15％的活性药物成分，0.01％-15％离子抑制剂，0.01％-1％交联剂，0.1％-10％高分子树脂，10％-35％溶剂，0.1％-15％肤感调节剂，10％-55％去离子水，0.1％-3％外观调节剂，0.01-1％的交联调节剂，0.01％-1％防腐剂，0.01％-5％透皮吸收促渗剂。
优选地，所述高分子水凝胶，包括以下质量百分含量的各组分：
1％-10％的活性成分，3％-10％离子抑制剂，0.1％-0.5％交联剂，5％-10％高分子树脂，20％-35％溶剂，1％-5％肤感调节剂，30％-55％去离子水，0.1％-1％外观调节 剂，0.1％-1％的交联调节剂，0.1-0.5％防腐剂，1％-5％透皮吸收促渗剂。
更优选地，所述高分子水凝胶，包括以下质量百分含量的各组分：
4％-6％的活性成分，5％离子抑制剂，0.1％-0.2％交联剂，8％-9.5％高分子树脂，30％-33％溶剂，0.1％肤感调节剂，40.9％-52.04％去离子水，0.05％-0.1％外观调节剂，0.2％的交联调节剂，0.1％防腐剂，0.5％透皮吸收促渗剂。
优选地，所述活性成分包括药物成分、中药粉末或提取液、氨基酸、植物提取物中的任一种或多种。例如所述药物成分可选自葡萄糖胺，辣椒提取物，樟脑，薄荷醇，水杨酸甲酯，利多卡因，盐酸利多卡因等镇痛作用成分，还可选自阿司匹林，安乃近，对乙酰氨基酚，吲哚美辛，吡罗昔康，酮咯酸，可的松、氢化可的松、地塞米松，甘草次酸，联苯乙酸，洛索洛芬等消炎镇痛作用成分；所述中药粉末或提取液可选自冰片，芦荟，山茶花，乳香树脂，山金车蒙大拿花，当归，决明子，金盏草花，紫锥菊，杜松果实等中药粉末或者提取液；所述氨基酸可选自甘氨酸、丝氨酸、L－色氨酸、精氨酸、鸟氨酸、5－羟色氨酸，L－茶氨酸、茶叶茶氨酸等；所述植物提取物可选自缬草提取物、西番莲提取物、柠檬香脂叶、黄春秋菊提取物、薰衣草提取物，洋甘菊提取物、香蜂草提取物、酸樱桃提取物、蒜提取物、留兰香提取物等助眠成分的植物提取物，还可选自冬青油，白芷油，当归油，肉桂油，桉叶油，薄荷油，龙脑油，广藿香油等具有提神醒脑的植物提取物。
优选地，所述离子抑制剂包括聚乙烯吡咯烷酮，聚乙烯醇的非离子型离子抑制剂中的至少一种。
优选地，所述交联剂为甘羟铝或氢氧化铝。
优选地，所述高分子树脂为聚丙烯酸，聚丙烯酸钠中的至少一种。
优选地，所述溶剂包括丙三醇，丙二醇，矿物油，聚氧乙烯脱水山梨醇单油酸酯中的至少一种。
优选地，所述肤感调节剂为高岭土，羧甲基纤维素纳中的至少一种；
所述外观调节剂为钛白粉。
更优选地，所述肤感调节剂为高岭土，其为吸油无机粉末，可以调节在运动过程中皮肤上分泌的油脂成分。
优选地，所述交联调节剂为酒石酸，柠檬酸，EDTA-2Na,EDTA-4Na，苹果酸，乳酸中的至少一种；
所述的防腐剂为苯扎氯铵，尼泊金甲酯，尼泊金丙酯，苯氧乙醇的至少一种；
所述的透皮吸收促渗剂为肉豆蔻酸异丙酯，二甲基亚砜，氮酮中的至少一种。
本发明还提供了一种具有缓释功能的高分子水凝胶的制备方法，包括以下步骤：
S1、将聚丙烯酸钠，交联剂，交联调节剂，外观调节剂，与溶剂常温下搅拌8-15分钟，分散均匀为A相；
S2、将活性药物成分加入溶剂中常温溶解完全为B相；
S3、将离子抑制剂，肤感调节剂，透皮吸收促渗剂，防腐剂常温下搅拌15-20分钟，形成混合液为C相；
S4、将B相与C相在均质乳化机中乳化，然后将乳化后的液体倒入真空搅拌釜中，再将A相混入其中，搅拌，即得具有缓释功能的高分子水凝胶。
优选地，步骤S4中，所述乳化的转速为4000r/min，乳化时间为10-15分钟；所述搅拌的速度为40-60r/min，搅拌时间为10-15分钟。
本发明还提供了一种水凝胶弹性贴片，包括依次设置的弹性材料层、具有缓释功能的高分子水凝胶层和离型覆盖层；
所述弹性材料层上复合有疏水性助剂，或弹性材料层与防水材料复合，或具有空气层结构的弹性材料层；
所述具有缓释功能的高分子水凝胶层包括上述的高分子水凝胶。
优选地，所述离型覆盖层包括各种材质具有离型效果的覆盖层，具体选自硅油纸，珠光膜，PP离型膜，PET离型膜中的任一种。
优选地，所述疏水性助剂选自聚丙烯酸氟烷基酯共聚物、有机硅、氟碳聚合物、长链烷烃酯及其共聚物中的至少一种；
优选地，所述防水材料的材质为热塑性弹性体或橡胶。
优选地，所述弹性材料层上复合疏水性助剂的弹性材料层的制备方法如下：
将疏水助剂与水按6:94-12:88的比例成混合液，将弹性材料进行染色固色，整理后，浸入混合液后5分钟，在120-140℃预烘2分钟，再依次在150℃-155℃烘1分钟，160℃-165℃烘2分钟，180-190℃烘5分钟后，即得复合疏水性助剂的弹性材料层。
本发明还提供了一种水凝胶弹性贴片的制备方法，包括以下步骤：在弹性材料层上涂布具有缓释功能的高分子水凝胶层，然后覆盖离型覆盖层，剪切，固化，包装，即得。
与现有技术相比，本发明具有如下的有益效果：
1、本发明采用的水凝胶是将聚丙烯酸钠以交联状态存在于亲水性基质中，所形成的高分子骨架包埋活性成分，胶体复配使用非离子型的水性离子抑制剂，提高胶体的耐 盐性，该亲水性高分子水凝胶具有良好的亲肤性和皮肤透过性，缓释药物时间长，与皮肤有良好的生物粘贴性，可反复揭帖，无残留胶体，特别是使用者在运动过程中使用，即使人体出汗仍然保持良好的粘贴性。
2、本发明制备的水凝胶弹性贴片适合运动时使用，不易脱落；且采用的弹性材料透气性、弹性形变力效果好，特别适用于肘关节处，能很好的贴。
3、现有的弹性布由于弹性大，易于拉扯，空隙较大，水凝胶涂布时由于具有流动性，胶体易于从弹性布的空隙流出来；而本发明通过在弹性材料层上进行疏水处理或将弹性材料与TPU复合，解决了弹性布与水凝胶结合易透布的风险，同时保留了弹性布透气性好的优点。
通过阅读参照以下附图对非限制性实施例所做的详细描述，本发明的其他特征、目的和优点将会变得更明显：
图1为水凝胶弹性贴片的结构图，其中，1－离型覆盖层，2－具有缓释功能的高分子水凝胶层，3－弹性材料层。
下面结合具体实施例对本发明进行详细说明。以下实施例将有助于本领域的技术人员进一步理解本发明，但不以任何形式限制本发明。应当指出的是，对本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以作出若干变形和改进。这些都属于本发明的保护范围。
实施例1
本实施例提供了一种具有缓释功能的高分子水凝胶，包括以下质量百分含量的各组分：4％利多卡因(活性成分)，5％聚乙烯吡咯烷酮(离子抑制剂)，0.1％甘羟铝(交联剂)，5％聚丙烯酸钠(高分子树脂)，聚丙烯酸3％(高分子树脂)，24％的丙三醇(溶剂)，5％丙二醇(溶剂)，1％聚氧乙烯脱水山梨醇单油酸酯(溶剂)，0.1％高岭土(肤感调节剂)，0.05％钛白粉(外观调节剂)，0.1％酒石酸(交联调节剂)，0.1％EDTA-2Na(交联调节剂)，0.1％苯氧乙醇(防腐剂)，0.5％二甲基亚砜(透皮吸收促渗剂)，51.95％去离子水。
所述高分子水凝胶的制备方法如下：
(1)将聚丙烯酸钠，甘羟铝，高岭土，EDTA-2Na,酒石酸与丙三醇常温下搅拌10分钟为A相；
(2)将利多卡因加入丙二醇和聚氧乙烯脱水山梨醇单油酸酯中常温溶解完全为B相；
(3)将聚乙烯吡咯烷酮，钛白粉，二甲基亚砜，苯氧乙醇，在去离子水中常温下搅拌15-20分钟，形成混合液为C相。
(4)将B相与C相在均质乳化机中乳化10-15分钟，转速为4000r/min.，然后将混合后的液体倒入真空搅拌釜中，再将A相混入其中，搅拌10-15分钟，搅拌速度为40-60r/min,形成包埋活性药物成分的水凝胶膏体。
实施例2
本实施例提供了一种具有缓释功能的高分子水凝胶，包括以下质量百分含量的各组分：5％薄荷醇(活性成分)，5％聚乙烯吡咯烷酮(离子抑制剂)，0.1％甘羟铝(交联剂)，5.5％聚丙烯酸钠(高分子)，3.5％聚丙烯酸(高分子)，23％的甘油(溶剂)，7％丙二醇(溶剂)，1％聚氧乙烯脱水山梨醇单油酸酯(溶剂)，0.1％羧甲基纤维素纳(肤感调节剂)，0.1％钛白粉(外观调节剂)，0.1％酒石酸(交联调节剂)，0.1％EDTA-2Na，(交联调节剂)0.1％苯扎氯铵(防腐剂)，0.5％肉豆蔻酸异丙酯(透皮吸收促渗剂)，48.9％去离子水。
所述高分子水凝胶的制备方法如下：
(1)将聚丙烯酸钠，甘羟铝，羧甲基纤维素钠，EDTA-2Na,酒石酸与丙三醇常温下搅拌10分钟为A相；
(2)将薄荷醇加入丙二醇和聚氧乙烯脱水山梨醇单油酸酯中常温溶解完全为B相；
(3)将聚乙烯吡咯烷酮，钛白粉，肉蔻酸异丙酯，苯氧乙醇，在去离子水中常温下搅拌15-20分钟，形成混合液为C相。
(4)将B相与C相在均质乳化机中乳化10-15分钟，转速为4000r/min.，然后将混合后的液体倒入真空搅拌釜中，再将A相混入其中，搅拌10-15分钟，搅拌速度为40-60r/min,形成包埋活性成分的水凝胶膏体。
实施例3
本实施例提供了一种具有缓释功能的高分子水凝胶，包括以下质量百分含量的各组分：5％薄荷醇(活性成分)，5％聚乙烯吡咯烷酮(离子抑制剂)，0.2％氢氧化铝(交 联剂)，3.5％聚丙烯酸钠(高分子)，6％聚丙烯酸(高分子)，25％的甘油(溶剂)，7％丙二醇(溶剂)，1％聚氧乙烯脱水山梨醇单油酸酯(溶剂)，0.1％羧甲基纤维素纳(肤感调节剂)，0.1％钛白粉(外观调节剂)，0.1％酒石酸(交联调节剂)，0.1％EDTA-2Na(交联调节剂)，0.1％尼泊金甲酯(防腐剂)，0.1％尼泊金丙酯(防腐剂)，0.5％肉豆蔻酸异丙酯(透皮吸收促渗剂)，46.2％去离子水。
所述高分子水凝胶的制备方法如下：
(1)将聚丙烯酸钠，氢氧化铝，羧甲基纤维素钠，EDTA-2Na,酒石酸与丙三醇常温下搅拌10分钟为A相；
(2)将薄荷醇加入丙二醇和聚氧乙烯脱水山梨醇单油酸酯中常温溶解完全为B相；
(3)将聚乙烯吡咯烷酮，钛白粉，肉蔻酸异丙酯，尼泊金甲酯，尼泊金丙酯，在去离子水中常温下搅拌15-20分钟，形成混合液为C相。
(4)将B相与C相在均质乳化机中乳化10-15分钟，转速为4000r/min.，然后将混合后的液体倒入真空搅拌釜中，再将A相混入其中，搅拌10-15分钟，搅拌速度为40-60r/min,形成包埋活性成分的水凝胶膏体。
实施例4
本发明提供了一种具有缓释功能的高分子水凝胶，其各组分组成与实施例1基本相同，不同之处仅在于：本实施例采用聚乙烯醇代替聚乙烯吡咯烷酮。
上述实施例1-4所制备的水凝胶具有良好的亲肤性和皮肤透过性，缓释药物时间长，与皮肤有良好的生物粘贴性，可反复揭帖，无残留胶体，特别是使用者在运动过程中使用，即使人体出汗仍然保持良好的粘贴性。
实施例5
本发明提供了一种具有缓释功能的高分子水凝胶，其各组分组成与实施例1基本相同，不同之处仅在于：本实施例采用聚乙烯醇代替聚乙烯吡咯烷酮，且聚乙烯醇含量为3％，去离子水含量为53.95％。
实施例6
本发明提供了一种具有缓释功能的高分子水凝胶，其各组分组成与实施例1基本相同，不同之处仅在于：本实施例采用聚乙烯醇代替聚乙烯吡咯烷酮，且聚乙烯醇含量为8％，去离子水含量为48.95％。
实施例7
本发明提供了一种具有缓释功能的高分子水凝胶，其各组分组成与实施例1基本相 同，不同之处仅在于：本实施例采用聚乙烯醇代替聚乙烯吡咯烷酮，且聚乙烯醇含量为10％，去离子水含量为46.95％。
对比例1
本对比例提供了一种具有缓释功能的高分子水凝胶，其各组分组成与实施例1基本相同，不同之处仅在于：本对比例中不添加交联剂，去离子水含量为52.14％。
所述高分子水凝胶的制备方法与实施例1相同。
制得的胶体由于没有交联剂，交联过程发生过快或者过慢，胶体交联程度不均匀，无法进行涂布。
对比例2
本对比例提供了一种具有缓释功能的高分子水凝胶，其各组分组成与实施例1基本相同，不同之处仅在于：本对比例中不添加离子抑制剂，去离子水含量为56.95％。
所述高分子水凝胶的制备方法与实施例1相同。
效果验证：
将实施例1和对比例2制备的水凝胶膏体涂布在弹性布上，覆盖离型覆盖层，剪切，固化，得水凝胶膏贴。将制得的水凝胶膏贴进行效果测试，具体测试方法和结果如下：
分别将实施例1和对比例2的凝胶贴裁剪成30cm*2.5cm条状样品3片，分别在每片水凝胶膏贴表面均匀涂抹约2克人工汗液在25±2℃，60％RH的条件下预处理2小时，按照GB/T 2792-2014剥离力测试方法，测试结果如下表1所示：
表1
从上述测试结果来看，对比例2由于未加入离子抑制剂，在浸入人工汗液的条件下，黏附效果明显降低。
根据前述方法将实施例2-7凝胶贴裁剪成30cm*2.5cm条状样品3片，分别在每片水凝胶膏贴表面均匀涂抹约2克人工汗液在25±2℃，60％RH的条件下预处理2小时，按照GB/T 2792-2014剥离力测试方法，测试结果(取3片样品的平均值)如下表2所 示：
表2
实施例8
本实施例提供了一种水凝胶弹性贴片，如图1所示，包括依次设置的离型覆盖层1、具有缓释功能的高分子水凝胶层2和弹性材料层3。所述弹性材料层3为复合疏水性助剂的弹性布，离型覆盖层1为珠光膜。
所述具有缓释功能的高分子水凝胶层包括以下质量百分含量的各组分：4％利多卡因(活性药物成分)，5％聚乙烯吡咯烷酮(离子抑制剂)，0.1％甘羟铝(交联剂)，5％聚丙烯酸钠(高分子树脂)，聚丙烯酸3％(高分子树脂)，24％的丙三醇(溶剂)，5％丙二醇(溶剂)，1％聚氧乙烯脱水山梨醇单油酸酯(溶剂)0.1％高岭土(肤感调节剂)，0.05％钛白粉(外观调节剂)，0.1％酒石酸(交联调节剂)，0.1％EDTA-2Na(交联调节剂)，0.1％苯氧乙醇(防腐剂)，0.5％二甲基亚砜(透皮吸收促渗剂)，51.95％去离子水。
所述复合疏水性助剂的弹性布的制备方法如下：将聚丙烯酸氟烷基酯共聚物(疏水性助剂)与水按6:94的比例成混合液，将弹性材料进行染色固色，整理后，浸入混合液5分钟，然后在120-140℃预烘2分钟，再依次在150℃-155℃烘1分钟，160℃-165℃烘2分钟，180-190℃烘5分钟后，即得。根据AATCC-127-1977中的测试方法进行测试，该弹性布的疏水等级可达5级以上。
本实施例所述水凝胶弹性贴片的制备方法如下：
(1)将聚丙烯酸钠，甘羟铝，高岭土，EDTA-2Na,酒石酸与丙三醇常温下搅拌10分钟为A相；
(2)将利多卡因加入丙二醇和聚氧乙烯脱水山梨醇单油酸酯中常温溶解完全为B相；
(3)将聚乙烯吡咯烷酮，钛白粉，二甲基亚砜，苯氧乙醇，在去离子水中常温下搅拌15-20分钟，形成混合液为C相。
(4)将B相与C相在均质乳化机中乳化10-15分钟，转速为4000r/min.，然后将 混合后的液体倒入真空搅拌釜中，再将A相混入其中，搅拌10-15分钟，搅拌速度为40-60r/min，形成具有缓释功能的高分子水凝胶。
(5)在复合疏水性助剂的弹性布上涂布具有缓释功能的高分子水凝胶，然后覆盖珠光膜，剪切，固化，包装，即得。
本发明制备的水凝胶弹性贴片由于弹性布的疏水处理，水凝胶在弹性布上不发生渗透。
实施例9
本实施例提供了一种水凝胶弹性贴片，如图1所示，包括依次设置的离型覆盖层1、具有缓释功能的高分子水凝胶层2和弹性材料层3。所述弹性材料层3为复合疏水性助剂的弹性布，离型覆盖层1为珠光膜。
所述具有缓释功能的高分子水凝胶层包括以下质量百分含量的各组分：5％薄荷醇(活性成分)，5％聚乙烯吡咯烷酮(离子抑制剂)，0.1％甘羟铝(交联剂)，5.5％聚丙烯酸钠(高分子)，3.5％聚丙烯酸(高分子)，23％的甘油(溶剂)，7％丙二醇(溶剂)，1％聚氧乙烯脱水山梨醇单油酸酯(溶剂)，0.1％羧甲基纤维素纳(肤感调节剂)，0.1％钛白粉(外观调节剂)，0.1％酒石酸(交联调节剂)，0.1％EDTA-2Na，(交联调节剂)0.1％苯扎氯铵(防腐剂)，0.5％肉豆蔻酸异丙酯(透皮吸收促渗剂)，48.9％去离子水。
所述复合疏水性助剂的弹性布的制备方法如下：将聚丙烯酸氟烷基酯共聚物(疏水性助剂)与水按8:92的比例成混合液，将弹性材料进行染色固色，整理后，浸入混合液5分钟，然后在120-140℃预烘2分钟，再依次在150℃-155℃烘1分钟，160℃-165℃烘2分钟，180-190℃烘5分钟后，即得。根据AATCC-127-1977中的测试方法进行测试，该弹性布的疏水等级可达5级以上。
本实施例所述水凝胶弹性贴片的制备方法如下：
(1)将聚丙烯酸钠，甘羟铝，羧甲基纤维素钠，EDTA-2Na,酒石酸与丙三醇常温下搅拌10分钟为A相；
(2)将薄荷醇加入丙二醇和聚氧乙烯脱水山梨醇单油酸酯中常温溶解完全为B相；
(3)将聚乙烯吡咯烷酮，钛白粉，肉蔻酸异丙酯，苯氧乙醇，在去离子水中常温下搅拌15-20分钟，形成混合液为C相。
(4)将B相与C相在均质乳化机中乳化10-15分钟，转速为4000r/min.，然后将混合后的液体倒入真空搅拌釜中，再将A相混入其中，搅拌10-15分钟，搅拌速度为 40-60r/min,形成包埋活性成分的水凝胶膏体。
(5)在复合疏水性助剂的弹性布上涂布具有缓释功能的高分子水凝胶，然后覆盖珠光膜，剪切，固化，包装，即得。
本发明制备的水凝胶弹性贴片由于弹性布的疏水处理，水凝胶在弹性布上不发生渗透。
实施例10
本实施例提供了一种水凝胶弹性贴片，如图1所示，包括依次设置的离型覆盖层1、具有缓释功能的高分子水凝胶层2和弹性材料层3。所述弹性材料层3为复合疏水性助剂的弹性布，离型覆盖层1为pp离型膜。
所述具有缓释功能的高分子水凝胶层包括以下质量百分含量的各组分：5％薄荷醇(活性药物成分)，5％聚乙烯吡咯烷酮(离子抑制剂)，0.2％氢氧化铝(交联剂)，3.5％聚丙烯酸钠(高分子)，6％聚丙烯酸(高分子)，25％的甘油(溶剂)，7％丙二醇(溶剂)，1％聚氧乙烯脱水山梨醇单油酸酯(溶剂)，0.1％羧甲基纤维素纳(肤感调节剂)，0.1％钛白粉(外观调节剂)，0.1％酒石酸(交联调节剂)，0.1％EDTA-2Na(交联调节剂)，0.1％尼泊金甲酯(防腐剂)，0.1％尼泊金丙酯(防腐剂)，0.5％肉豆蔻酸异丙酯(透皮吸收促渗剂)，46.2％去离子水。
所述复合疏水性助剂的弹性布的制备方法如下：将聚丙烯酸氟烷基酯共聚物(疏水性助剂)与水按9:91的比例成混合液，将弹性材料进行染色固色，整理后，浸入混合液5分钟，然后在120-140℃预烘2分钟，再依次在150℃-155℃烘1分钟，160℃-165℃烘2分钟，180-190℃烘5分钟后，即得。根据AATCC-127-1977中的测试方法进行测试，该弹性布的疏水等级可达5级以上。
所述水凝胶弹性贴片的制备方法如下：
(1)将聚丙烯酸钠，氢氧化铝，羧甲基纤维素钠，EDTA-2Na,酒石酸与丙三醇常温下搅拌10分钟为A相；
(2)将薄荷醇加入丙二醇和聚氧乙烯脱水山梨醇单油酸酯中常温溶解完全为B相；
(3)将聚乙烯吡咯烷酮，钛白粉，肉蔻酸异丙酯，尼泊金甲酯，尼泊金丙酯，在去离子水中常温下搅拌15-20分钟，形成混合液为C相。
(4)将B相与C相在均质乳化机中乳化10-15分钟，转速为4000r/min.，然后将混合后的液体倒入真空搅拌釜中，再将A相混入其中，搅拌10-15分钟，搅拌速度为40-60r/min,形成包埋活性成分的水凝胶膏体。
(5)在复合疏水性助剂的弹性布上涂布具有缓释功能的高分子水凝胶，然后覆盖pp离型膜，剪切，固化，包装，即得。
本发明制备的水凝胶弹性贴片由于弹性布的疏水处理，水凝胶在弹性布上不发生渗透。
实施例11
本发明提供了一种水凝胶弹性贴片，与实施例8的结构基本相同，不同仅在于：采用的具有缓释功能的高分子水凝胶的各组分组成中，本实施例采用聚乙烯醇代替聚乙烯吡咯烷酮。
上述实施例8-11所制备的水凝胶具有良好的亲肤性和皮肤透过性，缓释药物时间长，与皮肤有良好的生物粘贴性，可反复揭帖，无残留胶体，特别是使用者在运动过程中使用，即使人体出汗仍然保持良好的粘贴性。
实施例12
本发明提供了一种水凝胶弹性贴片，与实施例8的结构基本相同，不同仅在于：采用的具有缓释功能的高分子水凝胶的各组分组成中，本实施例采用聚乙烯醇代替聚乙烯吡咯烷酮，且聚乙烯醇含量为3％，去离子水含量为53.95％。
实施例13
本发明提供了一种水凝胶弹性贴片，与实施例8的结构基本相同，不同仅在于：采用的具有缓释功能的高分子水凝胶的各组分组成中，本实施例采用聚乙烯醇代替聚乙烯吡咯烷酮，且聚乙烯醇含量为8％，去离子水含量为48.95％。
实施例14
本发明提供了一种水凝胶弹性贴片，与实施例8的结构基本相同，不同仅在于：采用的具有缓释功能的高分子水凝胶的各组分组成中，本实施例采用聚乙烯醇代替聚乙烯吡咯烷酮，且聚乙烯醇含量为10％，去离子水含量为46.95％。
对比例3
本对比例提供了一种水凝胶弹性贴片，其结构组成与实施例8基本相同，不同之处仅在于：本对比例的具有缓释功能的高分子水凝胶层中不添加交联剂，去离子水含量为52.14％。
所述高分子水凝胶的制备方法与实施例8相同。
本发明制备的水凝胶弹性贴片制得的胶体由于没有交联剂，交联过程发生过快或者过慢，胶体交联程度不均匀，无法进行涂布。
对比例4
本对比例提供了一种水凝胶弹性贴片，其结构组成与实施例8基本相同，不同之处仅在于：本对比例的具有缓释功能的高分子水凝胶层中不添加离子抑制剂，去离子水含量为56.95％。
所述高分子水凝胶的制备方法与实施例8相同。
本发明制备的水凝胶弹性贴片长时间贴敷，由于人体出汗，易发生失黏脱落。
对比例5
本对比例提供了一种水凝胶弹性贴片，其结构组成与实施例8基本相同，不同之处仅在于：本对比例采用的弹性材料层为常规弹性布(即未复合疏水性助剂的弹性布)。
本发明制备的水凝胶弹性贴片由于弹性布未进行疏水处理，水凝胶在弹性布上发生渗透。
效果验证：
将实施例8和对比例4制备的水凝胶弹性贴片裁剪成30cm*2.5cm条状样品3片，分别在每片水凝胶弹性贴片表面均匀涂抹约2克人工汗液在25±2℃，60％RH的条件下预处理2小时，按照GB/T 2792-2014剥离力测试方法，测试结果如下表3所示：
表3
从上述测试结果来看，对比例4由于未加入离子抑制剂，在浸入人工汗液的条件下，黏附效果明显降低。
根据前述方法将实施例9-14制备的水凝胶弹性贴片裁剪成30cm*2.5cm条状样品3片，分别在每片水凝胶弹性贴片表面均匀涂抹约2克人工汗液在25±2℃，60％RH的条件下预处理2小时，按照GB/T 2792-2014剥离力测试方法，测试结果(取3片样品的平均值)如下表4所示：
表4
本发明也可将水凝胶涂布在复合的防水复合材料上，或者具有一定结构的空气层材料上，解决胶体渗出的问题，且产品形状，不局限于附图，大小可任意裁切，包含产品表面镂空的产品，增大透气性。
上述地对实施例的描述是为便于该技术领域的普通技术人员能理解和使用发明。熟悉本领域技术的人员显然可以容易地对这些实施例做出各种修改，并把在此说明的一般原理应用到其他实施例中而不必经过创造性的劳动。因此，本发明不限于上述实施例，本领域技术人员根据本发明的揭示，不脱离本发明范畴所作出的改进和修改都应该在本发明的保护范围之内。
Claims (14)
- 一种具有缓释功能的高分子水凝胶，其特征在于，包括以下质量百分含量的各组分：0.01％-15％的活性成分，0.01％-15％离子抑制剂，0.01％-1％交联剂，0.1％-10％高分子树脂，10％-35％溶剂，0.1％-15％肤感调节剂，10％-55％去离子水，0.1％-3％外观调节剂，0.01-1％的交联调节剂，0.01％-1％防腐剂，0.01％-5％透皮吸收促渗剂。
- 根据权利要求1所述的具有缓释功能的高分子水凝胶，其特征在于，所述活性成分包括药物成分、中药粉末或提取液、氨基酸、植物提取物中的任一种或多种。
- 根据权利要求1所述的具有缓释功能的高分子水凝胶，其特征在于，所述离子抑制剂包括聚乙烯吡咯烷酮，聚乙烯醇的非离子型离子抑制剂中的至少一种。
- 根据权利要求1所述的具有缓释功能的高分子水凝胶，其特征在于，所述交联剂为甘羟铝或氢氧化铝。
- 根据权利要求1所述的具有缓释功能的高分子水凝胶，其特征在于，所述高分子树脂为聚丙烯酸，聚丙烯酸钠中的至少一种。
- 根据权利要求1所述的具有缓释功能的高分子水凝胶，其特征在于，所述溶剂包括丙三醇，丙二醇，矿物油，聚氧乙烯脱水山梨醇单油酸酯中的至少一种。
- 根据权利要求1所述的具有缓释功能的高分子水凝胶，其特征在于，所述肤感调节剂为高岭土，羧甲基纤维素纳中的至少一种；所述外观调节剂为钛白粉。
- 根据权利要求1所述的具有缓释功能的高分子水凝胶，其特征在于，所述交联调节剂为酒石酸，柠檬酸，EDTA-2Na，EDTA-4Na，苹果酸，乳酸中的至少一种；所述的防腐剂为苯扎氯铵，尼泊金甲酯，尼泊金丙酯，苯氧乙醇的至少一种；所述的透皮吸收促渗剂为肉豆蔻酸异丙酯，二甲基亚砜，氮酮中的至少一种。
- 一种根据权利要求1所述的具有缓释功能的高分子水凝胶的制备方法，其特征在于，包括以下步骤：S1、将聚丙烯酸钠，交联剂，交联调节剂，外观调节剂，与部分溶剂常温下搅拌8-15分钟，分散均匀为A相；S2、将活性药物成分加入部分溶剂中常温溶解完全为B相；S3、将离子抑制剂，肤感调节剂，透皮吸收促渗剂，防腐剂常温下搅拌15-20分钟， 形成混合液为C相；S4、将B相与C相在均质乳化机中乳化，然后将乳化后的液体倒入真空搅拌釜中，再将A相混入其中，搅拌，即得具有缓释功能的高分子水凝胶。
- 根据权利要求9所述的具有缓释功能的高分子水凝胶的制备方法，其特征在于，步骤S4中，所述乳化的转速为4000r/min，乳化时间为10-15分钟；所述搅拌的速度为40-60r/min，搅拌时间为10-15分钟。
- 一种水凝胶弹性贴片，其特征在于，包括依次设置的弹性材料层、具有缓释功能的高分子水凝胶层和离型覆盖层；所述弹性材料层为复合有疏水性助剂的弹性材料层，或为弹性材料与防水材料复合形成的材料层，或为具有空气层结构的弹性材料层。所述高分子水凝胶层包含权利要求1所述的高分子水凝胶。
- 根据权利要求11所述的水凝胶弹性贴片，其特征在于，所述疏水性助剂选自聚丙烯酸氟烷基酯共聚物、有机硅、氟碳聚合物、长链烷烃酯及其共聚物中的至少一种；所述防水材料的材质为热塑性弹性体或橡胶。
- 根据权利要求11或12所述的水凝胶弹性贴片，其特征在于，所述复合疏水性助剂的弹性材料层的制备方法如下：将疏水助剂与水按6:94-12:88的比例成混合液，将弹性材料进行染色固色，整理后，浸入混合液后5分钟，在120-140℃预烘2分钟，再依次在150℃-155℃烘1分钟，160℃-165℃烘2分钟，180-190℃烘5分钟后，即得复合疏水性助剂的弹性材料层。
- 一种根据权利要求11所述的水凝胶弹性贴片的制备方法，其特征在于，包括以下步骤：在弹性材料层上涂布具有缓释功能的高分子水凝胶层，然后覆盖离型覆盖层，剪切，固化，包装，即得。
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