Hydrogel cold compress patch, cold and hot compress patch set prepared from hydrogel cold compress patch and application of hydrogel cold compress patch

Abstract

The invention relates to the technical field of medical application. The invention provides a hydrogel cold compress patch as well as a cold and hot compress patch set prepared from the hydrogel cold compress patch and application of the hydrogel cold compress patch. The hydrogel cold compress patch is prepared from the following raw materials in parts by weight: 26-65 parts of a matrix component, 1.5-7 parts of a cooling component, 0.54-2.06 parts of a pain relieving component and 25.94-71.96 parts of water. The invention provides a product which is convenient to carry, suitable for emergency treatment in the early stage and the acute stage and capable of treating various diseases. By using the hydrogel cold compress patch, the problems of early cold compress treatment and moisture preservation of burns and scalds and soft tissue injuries can be solved, and meanwhile, high-temperature diseases such as high fever and heatstroke can be coped with; the self-heating patch can solve the related problems of environment temperature loss, frostbite, dysmenorrhea and hot compress treatment of soft tissue injury.

Description

Technical Field

[0001] The present invention relates to the technical field of medical compresses, and in particular to a hydrogel cold compress and a cold and hot compress set prepared therefrom and applications thereof. Background Art

[0002] In recent years, the number of people engaging in sports has gradually increased, and the number of people participating in outdoor training such as marathon, mountain climbing, long-distance hiking, cycling, and regular high-intensity physical training has gradually increased. This makes it easy to suffer from acute soft tissue injuries, such as acute sprains of the waist, knees, ankles, wrists and other joints. During long-distance outdoor training, due to weather reasons, it is easy to suffer from a series of unpredictable injuries such as heat stroke, acute high fever, rapid hypothermia, burns and frostbite.

[0003] At present, due to the relatively complex nature of sports diseases, there is a lack of a disease treatment first aid kit that is easy to carry, suitable for early and acute emergency treatment, and can cope with a variety of diseases. Summary of the invention

[0004] The purpose of the present invention is to provide a hydrogel cold compress patch and a cold and hot compress patch set and application prepared therefrom, to provide a product that is easy to carry, suitable for early and acute emergency treatment, and can cope with the treatment of various diseases.

[0005] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0006] The invention provides a hydrogel cold compress patch, which comprises the following raw materials in parts by weight: 26 to 65 parts of a matrix component, 1.5 to 7 parts of a cooling component, 0.54 to 2.06 parts of a pain-relieving component, and 25.94 to 71.96 parts of water.

[0007] Preferably, the matrix component comprises the following raw materials in parts by weight: 10 to 30 parts of hyaluronic acid, 10 to 20 parts of gelatin, 1 to 5 parts of silk protein, and 5 to 10 parts of glycerol.

[0008] Preferably, the cooling component comprises the following raw materials in parts by weight: 1 to 5 parts of borneol and 0.5 to 2 parts of water-soluble peppermint oil.

[0009] Preferably, the analgesic component comprises the following raw materials in parts by weight: 0.04-0.06 parts of cannabidiol and 0.5-2 parts of diclofenac sodium.

[0010] The present invention also provides a method for preparing the hydrogel cold compress patch, comprising the following steps:

[0011] (1) reacting 3-(4-benzylamino)-1,2,4,5-tetrazine with hyaluronic acid to obtain tetrazine-modified hyaluronic acid;

[0012] (2) subjecting gelatin to an amidation reaction with succinic anhydride to obtain succinic anhydride-modified gelatin;

[0013] (3) reacting 5-norbornene-2-methylamine with succinic anhydride-modified gelatin to obtain norbornene-modified gelatin;

[0014] (4) mixing tetrazine-modified hyaluronic acid and norbornene-modified gelatin in proportion to generate a bioorthogonal reaction, and adding silk protein, glycerol, a cooling component, an analgesic component, and water during the process to obtain a mixture;

[0015] (5) After the mixture is solidified, a hydrogel cold compress is obtained.

[0016] The present invention also provides the use of the hydrogel cold compress patch in preparing a cold and hot compress patch set.

[0017] The present invention also provides a hot and cold compress patch set, which comprises the hydrogel cold compress patch and the self-heating patch.

[0018] Preferably, the structure of the self-heating patch includes: a heat-generating inner core and an adhesive layer;

[0019] The structure of the heat-generating inner core comprises in sequence: a skin-friendly non-woven fabric material, a heat-insulating layer containing 0.01 to 0.03% of Panax notoginseng Chinese herbal medicine ingredients, a heat-generating layer containing self-heating materials, and a heat-insulating layer;

[0020] The adhesive layer is a skin-friendly tape.

[0021] Preferably, the hot and cold compress patch set includes 2 pairs of hydrogel cold compress patches and 2 pairs of self-heating patches.

[0022] The present invention provides a hydrogel cold compress patch and a cold and hot compress patch set and application prepared therefrom, wherein the hydrogel cold compress patch comprises the following raw materials in parts by weight: 26 to 65 parts of a matrix component, 1.5 to 7 parts of a cooling component, 0.54 to 2.06 parts of an analgesic component, and 25.94 to 71.96 parts of water. The present invention provides a product that is easy to carry, suitable for early and acute emergency treatment, and can cope with disease treatment of various types of diseases. The use of the hydrogel cold compress patch can solve the problems of early cold compress treatment and moisturizing of burns and scalds, and soft tissue injuries, and can also cope with high temperature diseases such as high fever and heat stroke; the self-heating patch can solve the problems related to environmental hypothermia, frostbite, dysmenorrhea, and hot compress treatment of soft tissue injuries. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 This is a structural diagram of the heat-generating inner core of the self-heating patch of the present invention;

[0024] Figure 2 This is the overall structure diagram of the self-heating patch of the present invention;

[0025] Figure 3 It is a schematic diagram of the pasting of the self-heating patch of the present invention. DETAILED DESCRIPTION

[0026] The invention provides a hydrogel cold compress patch, which comprises the following raw materials in parts by weight: 26 to 65 parts of a matrix component, 1.5 to 7 parts of a cooling component, 0.54 to 2.06 parts of a pain-relieving component, and 25.94 to 71.96 parts of water.

[0027] In the present invention, the amount of the matrix component is preferably 30 to 60 parts, more preferably 40 to 50 parts.

[0028] In the present invention, the amount of the cooling component is preferably 2 to 6 parts, more preferably 4 to 5 parts.

[0029] In the present invention, the amount of the analgesic component is preferably 1 to 2 parts, more preferably 1.5 parts.

[0030] In the present invention, the amount of water is preferably 30 to 60 parts, more preferably 40 to 50 parts.

[0031] In the present invention, the matrix component preferably includes the following raw materials in parts by weight: 10-30 parts of hyaluronic acid, 10-20 parts of gelatin, 1-5 parts of silk protein, and 5-10 parts of glycerol, and more preferably: 20 parts of hyaluronic acid, 15 parts of gelatin, 3 parts of silk protein, and 7-8 parts of glycerol.

[0032] In the present invention, the cooling component preferably includes the following raw materials in parts by weight: 1 to 5 parts of borneol and 0.5 to 2 parts of water-soluble peppermint oil, and more preferably: 3 parts of borneol and 1 to 1.5 parts of water-soluble peppermint oil.

[0033] In the present invention, the analgesic component preferably includes the following raw materials in parts by weight: 0.04-0.06 parts of cannabidiol and 0.5-2 parts of diclofenac sodium, and more preferably: 0.05 parts of cannabidiol and 1-1.5 parts of diclofenac sodium.

[0034] The present invention also provides a method for preparing the hydrogel cold compress patch, comprising the following steps:

[0035] (1) reacting 3-(4-benzylamino)-1,2,4,5-tetrazine with hyaluronic acid to obtain tetrazine-modified hyaluronic acid;

[0036] (2) subjecting gelatin to an amidation reaction with succinic anhydride to obtain succinic anhydride-modified gelatin;

[0037] (3) reacting 5-norbornene-2-methylamine with succinic anhydride-modified gelatin to obtain norbornene-modified gelatin;

[0038] (4) mixing tetrazine-modified hyaluronic acid and norbornene-modified gelatin in proportion to generate a bioorthogonal reaction, and adding silk protein, glycerol, a cooling component, an analgesic component, and water during the process to obtain a mixture;

[0039] (5) After the mixture is solidified, a hydrogel cold compress is obtained.

[0040] In the present invention, the specific process of the reaction in step (1) is as follows: acidifying the hyaluronic acid aqueous solution with a strongly acidic ion exchange resin (such as Dowex 50W×8-200), then adjusting the pH of the filtrate to neutral using tetrabutylammonium hydroxide (TBA-OH), and finally freeze-drying to obtain HA-TBA; dissolving HA-TBA and 3-(4-benzylamino)-1,2,4,5-tetrazine (the molar ratio of carboxyl group to tetrazine is preferably 8 to 12:1, more preferably 10:1) in anhydrous dimethyl sulfoxide, adding condensing agents PYBOP and DIEA for amidation reaction (the molar ratio of condensing agent to HA-TBA is preferably 1:4 to 6, more preferably 1:5), reacting at room temperature for 10 to 12 hours, and obtaining tetrazine-modified hyaluronic acid after purification by dialysis.

[0041] In the present invention, the specific process of the amidation reaction described in step (2) is: dissolving succinic anhydride and gelatin in tetrahydrofuran (the molar ratio is preferably 1:0.8-1.2, more preferably 1:1), adding catalyst pyridine (the molar amount is preferably 1.8-2.2% of succinic anhydride, more preferably 2%), reacting at 45-55°C for 3-5 hours, and lyophilizing to obtain the product after dialysis.

[0042] In the present invention, the molar ratio of 5-norbornene-2-methylamine to succinic anhydride-modified gelatin in step (3) is 1:0.8-1.2, and more preferably 1:1.

[0043] In the present invention, the specific process of the reaction in step (3) is: dissolving 5-norbornene-2-methylamine and succinic anhydride-modified gelatin in dimethylformamide (DMF), reacting at room temperature for 5 to 7 hours under nitrogen protection, and lyophilizing after dialysis. The reaction time is preferably 6 hours.

[0044] In the present invention, the molar ratio of the tetrazine-modified hyaluronic acid to the norbornene-modified gelatin in step (4) is 1:0.8-1.2, and more preferably 1:1.

[0045] In the present invention, the reaction condition is preferably 50° C. for 4 hours.

[0046] The present invention also provides the use of the hydrogel cold compress patch in preparing a cold and hot compress patch set.

[0047] The present invention also provides a hot and cold compress patch set, which comprises the hydrogel cold compress patch and the self-heating patch.

[0048] In the present invention, the structure of the self-heating patch includes: a heat-generating inner core and an adhesive layer;

[0049] The structure of the heat-generating inner core comprises in sequence: a skin-friendly non-woven fabric material, a heat-insulating layer containing 0.01 to 0.03% of Panax notoginseng Chinese herbal medicine ingredients, a heat-generating layer containing self-heating materials, and a heat-insulating layer;

[0050] The adhesive layer is a skin-friendly tape.

[0051] In the present invention, the skin-friendly nonwoven material is used on the side close to the skin, which can reduce allergic reactions caused by adhesion.

[0052] The outer layer of the skin-friendly non-woven fabric material is a heat-insulating layer, which uses a multi-layer structure to stack thin layers of breathable nanofibers and contains 0.02% of Panax notoginseng Chinese herbal medicine ingredients to buffer the high heat generated by the heat production system, prevent and treat skin burns, and provide the function of promoting blood circulation and removing blood stasis.

[0053] The heat-generating bag is wrapped with airtight material on the outside of the insulation layer, and self-heating material is placed inside to facilitate heat generation and prevent leakage of heat-generating substances. The outer layer is a thermal insulation material such as thermal insulation chemical fiber, which retains heat to the skin and reduces damage to clothes. The outermost layer is the adhesive surface for fixing the heat-generating patch. The skin-friendly tape around it is used for sticking to tissues, and the center part fixes the entire heat-generating patch.

[0054] In the present invention, the hot and cold compress patch set preferably includes 2 pairs of hydrogel cold compress patches and 2 pairs of self-heating patches.

[0055] In the present invention, the self-heating patches are placed in a red outer packaging bag in the hot and cold compress set, which are numbered 3 and 4, and the hydrogel cold compress patches are placed in a blue outer packaging bag, which are marked as 1 and 2. Patch No. 1 has a stronger cooling sensation and a higher analgesic component, and is used for the initial treatment of acute injuries. Patch No. 2 has a weaker cooling sensation and a lower analgesic component. It can be used 12 hours after patch No. 1 is used, and can also be used as a spare patch for children's cooling treatment. Patches No. 3 and No. 4 have the same composition and structure, and can maintain a temperature of 40-50°C for 6-8 hours.

[0056] In the present invention, the ingredients of the hydrogel cold compress patch No. 1 are: 4 parts of borneol, 2 parts of water-soluble peppermint oil; 0.1 parts of cannabidiol, 2 parts of diclofenac sodium;

[0057] The ingredients of the hydrogel cold compress patch No. 2 are: 3 parts of borneol, 1 part of water-soluble peppermint oil; 0.04 parts of cannabidiol, and 1.5 parts of diclofenac sodium.

[0058] The technical solutions provided by the present invention are described in detail below in conjunction with the embodiments, but they should not be construed as limiting the protection scope of the present invention.

[0059] Example 1

[0060] 1. A method for preparing a hydrogel cold compress patch, comprising the following steps:

[0061] (1) Weigh raw materials according to the mass ratio of 20 parts of hyaluronic acid, 15 parts of gelatin, 3 parts of silk protein, 7 parts of glycerol, 3 parts of borneol, 1 part of water-soluble peppermint oil, 0.05 parts of cannabidiol, 1 part of diclofenac sodium, and 49.95 parts of water, and set aside;

[0062] (2) A hyaluronic acid (HA) aqueous solution (5% by mass volume ratio) was acidified with a strongly acidic ion exchange resin (Dowex 50W×8-200), and then the pH of the filtrate was adjusted to neutral using tetrabutylammonium hydroxide (TBA-OH), and finally freeze-dried to obtain HA-TBA; HA-TBA and 3-(4-benzylamino)-1,2,4,5-tetrazine (the molar ratio of carboxyl group to tetrazine was 10:1) were dissolved in anhydrous dimethyl sulfoxide, and condensation agents PYBOP and DIEA (the molar ratio of PYBOP and DIEA was 1:1) were added to carry out an amidation reaction (the molar ratio of condensation agent to HA-TBA was 1:5), and the reaction was carried out at room temperature for 11 hours. After purification by dialysis, tetrazine-modified hyaluronic acid was obtained;

[0063] (3) Succinic anhydride and gelatin were dissolved in tetrahydrofuran (molar ratio 1:1), and a catalyst pyridine (molar amount of 2% of succinic anhydride) was added, and the mixture was reacted at 50° C. for 4 hours. After dialysis, the mixture was freeze-dried to obtain the product;

[0064] (4) dissolving 5-norbornene-2-methylamine and succinic anhydride-modified gelatin in dimethylformamide (DMF) at a volume ratio of 1:1, reacting at room temperature for 6 hours under nitrogen protection, dialyzing and freeze-drying to obtain norbornene-modified gelatin;

[0065] (5) mixing tetrazine-modified hyaluronic acid and norbornene-modified gelatin in a volume ratio of 1:1 to produce a bioorthogonal reaction, and adding silk protein, glycerol, borneol, water-soluble peppermint oil, cannabidiol, diclofenac sodium and water to obtain a mixture;

[0066] (6) After the mixture is solidified, a hydrogel cold compress is obtained.

[0067] 2. A self-heating patch, the structure of which includes: skin-friendly non-woven fabric material, a thin layer of breathable nanofibers with a multi-layer structure stacked with 0.02% of Panax notoginseng Chinese herbal medicine ingredients, a heat-generating layer containing self-heating material, a heat-insulating layer and a skin-friendly tape.

[0068] Example 2

[0069] 1. A method for preparing a hydrogel cold compress patch, comprising the following steps:

[0070] (1) Weigh raw materials according to the mass ratio of 10 parts of hyaluronic acid, 10 parts of gelatin, 1 part of silk protein, 5 parts of glycerol, 1 part of borneol, 0.5 parts of water-soluble peppermint oil, 0.04 parts of cannabidiol, 0.5 parts of diclofenac sodium, and 71.96 parts of water, and set aside;

[0071] (2) A hyaluronic acid (HA) aqueous solution is acidified with a strongly acidic ion exchange resin (Dowex 50W×8-200), and then the pH of the filtrate is adjusted to neutral using tetrabutylammonium hydroxide (TBA-OH), and finally freeze-dried to obtain HA-TBA; HA-TBA and 3-(4-benzylamino)-1,2,4,5-tetrazine (the molar ratio of carboxyl group to tetrazine is 12:1) are dissolved in anhydrous dimethyl sulfoxide, and condensation agents PYBOP and DIEA are added to carry out an amidation reaction (the molar ratio of condensation agent to HA-TBA is 1:4), and the reaction is carried out at room temperature for 12 hours. After purification by dialysis, tetrazine-modified hyaluronic acid can be obtained;

[0072] (3) Succinic anhydride and gelatin were dissolved in tetrahydrofuran (molar ratio 1:0.8), and catalyst pyridine (molar amount was 2.2% of succinic anhydride) was added, and the mixture was reacted at 55° C. for 3 hours. After dialysis, the mixture was freeze-dried to obtain the product;

[0073] (4) dissolving 5-norbornene-2-methylamine and succinic anhydride-modified gelatin in dimethylformamide (DMF) at a volume ratio of 1:1.2, reacting at room temperature for 5 hours under nitrogen protection, dialyzing and freeze-drying to obtain norbornene-modified gelatin;

[0074] (5) mixing tetrazine-modified hyaluronic acid and norbornene-modified gelatin at a volume ratio of 1:0.8 to produce a bioorthogonal reaction, and adding silk protein, glycerol, borneol, water-soluble peppermint oil, cannabidiol, diclofenac sodium and water during the process to obtain a mixture;

[0075] (6) After the mixture is solidified, a hydrogel cold compress is obtained.

[0076] 2. A self-heating patch, the structure of which includes: skin-friendly non-woven fabric material, a thin layer of breathable nanofibers with a multi-layer structure stacked with 0.03% of Panax notoginseng Chinese herbal medicine ingredients, a heat-generating layer containing self-heating material, a heat-insulating layer and a skin-friendly tape.

[0077] Example 3

[0078] 1. A method for preparing a hydrogel cold compress patch, comprising the following steps:

[0079] (1) Weigh raw materials according to the mass ratio of 30 parts of hyaluronic acid, 20 parts of gelatin, 5 parts of silk protein, 10 parts of glycerol, 5 parts of borneol, 2 parts of water-soluble peppermint oil, 0.06 parts of cannabidiol, 2 parts of diclofenac sodium, and 25.94 parts of water, and set aside;

[0080] (2) A hyaluronic acid (HA) aqueous solution was acidified with a strongly acidic ion exchange resin (Dowex 50W×8-200), and then the pH of the filtrate was adjusted to neutral using tetrabutylammonium hydroxide (TBA-OH), and finally freeze-dried to obtain HA-TBA; HA-TBA and 3-(4-benzylamino)-1,2,4,5-tetrazine (the molar ratio of carboxyl group to tetrazine was 8:1) were dissolved in anhydrous dimethyl sulfoxide, and condensation agents PYBOP and DIEA were added for amidation reaction (the molar ratio of condensation agent to HA-TBA was 1:6), and the reaction was carried out at room temperature for 10 hours. After purification by dialysis, tetrazine-modified hyaluronic acid was obtained;

[0081] (3) Succinic anhydride and gelatin were dissolved in tetrahydrofuran (molar ratio 1:1.2), and a catalyst pyridine (molar amount of 1.8% of succinic anhydride) was added, and the mixture was reacted at 45°C for 5 hours. After dialysis, the mixture was freeze-dried to obtain the product;

[0082] (4) dissolving 5-norbornene-2-methylamine and succinic anhydride-modified gelatin in dimethylformamide (DMF) at a volume ratio of 1:0.8, reacting at room temperature for 7 hours under nitrogen protection, dialyzing and freeze-drying to obtain norbornene-modified gelatin;

[0083] (5) mixing tetrazine-modified hyaluronic acid and norbornene-modified gelatin in a volume ratio of 1:1.2 to produce a bioorthogonal reaction, and adding silk protein, glycerol, borneol, water-soluble peppermint oil, cannabidiol, diclofenac sodium and water to obtain a mixture;

[0084] (6) After the mixture is solidified, a hydrogel cold compress is obtained.

[0085] 2. A self-heating patch, the structure of which includes: skin-friendly non-woven fabric material, a thin layer of breathable nanofibers with a multi-layer structure stacked with 0.01% of Panax notoginseng Chinese herbal medicine ingredients, a heat-generating layer containing self-heating material, a heat-insulating layer and a skin-friendly tape.

[0086] Test example

[0087] 1. Preparation of patch

[0088] Prepare hydrogel cold compress patch No. 1 according to the mass ratio of 4 parts of borneol, 2 parts of water-soluble peppermint oil, 0.1 parts of cannabidiol, and 2 parts of diclofenac sodium;

[0089] Prepare hydrogel cold compress patch No. 2 according to the mass ratio of 3 parts of borneol, 1 part of water-soluble peppermint oil, 0.04 parts of cannabidiol, and 1.5 parts of diclofenac sodium;

[0090] The remaining components, methods and conditions of the self-heating patch are the same as those in Example 1.

[0091] 2. Experimental subjects: 126 patients with training injuries

[0092] The conditions of the subjects are shown in Table 1:

[0093] Table 1

[0094]

[0095] 1. Test group 1: ankle sprain group

[0096] (1) Subject population

[0097] Patching group: 13 patients with mild acute ankle sprain were treated with patches No. 1 to 4 in sequence, with each patch applied for 12 hours, achieving 24-hour cold compress analgesia and 24-hour hot compress; 6 patients with severe swelling and limited mobility were treated with a 4-day sequence of 1-1-2-2-3-3-4-4, achieving 2 days of cold compress and 2 days of hot compress; all patients with mild sprain were advised to immobilize within 2 days, and those with severe sprain were advised to immobilize for 5 days.

[0098] Control group: 13 patients with mild acute ankle sprains were advised to be immobilized within 2 days, and 6 patients with severe sprains were advised to be immobilized for 5 days.

[0099] (2) Evaluation of treatment efficacy

[0100] The therapeutic effect of the patients was evaluated on the 1st, 3rd, 5th, and 7th days after injury, and the improvement of the patients was comprehensively assessed from the aspects of changes in skin bruises, disappearance of soft tissue swelling, relief of local pain and pressure pain, and increase in joint range of motion.

[0101] (3) The results are as follows: The 3-day symptom improvement rate of mild patients was in the plaster group (10 cases were significantly improved, with an improvement rate of 76.9%) and in the control group (4 cases were improved, with an improvement rate of 30.8%); the 5-day symptom improvement rate of severe patients was in the plaster group (5 cases were significantly improved, with an improvement rate of 83.3%) and in the control group (1 case was improved, with an improvement rate of 17.8%), with statistically significant differences (p < 0.05).

[0102] 2. Test group 2: acute lumbar sprain

[0103] (1) Subject population

[0104] Patches group: 6 patients with acute lumbar sprain were treated with patches No. 1 to 4 in sequence, each patch lasting 12 hours, to achieve 24-hour cold compress analgesia and 24-hour hot compress. All patients with sprains were advised to rest in bed within 2 days.

[0105] Control group: 6 patients with acute lumbar sprain were advised to rest in bed within 2 days.

[0106] (2) Evaluation of treatment efficacy

[0107] The therapeutic effect of the patients was evaluated on the 1st to 3rd day after injury, mainly referring to the improvement of VAS scores of low back pain and pressure pain, and the low back range of motion to comprehensively judge the therapeutic effect.

[0108] (3) The results are as follows: The 3-day symptom improvement rate of the patients in the application group (5 cases improved significantly, the improvement rate was 83.3%) and the control group (3 cases improved, the improvement rate was 50.0%), which was statistically significantly different (p < 0.05).

[0109] 3. Test group 3: mild burns

[0110] (1) Subject population

[0111] Patching group: 8 patients with mild burns were treated with cold water flushing for 30 minutes, and then used No. 1 to 2 cold compress patches in sequence, each for 12 hours, to achieve 24-hour cold compress analgesia and maintain wound moisture.

[0112] Control group: 8 patients with mild burns were treated with cold water flushing for 30 minutes and were asked to be observed at any time.

[0113] (2) Evaluation of treatment efficacy

[0114] The therapeutic effect of the patients was evaluated on the 1st, 3rd and 5th day after injury, and the therapeutic effect was evaluated from the changes in skin redness and swelling, whether blisters were formed, and the improvement of spontaneous pain and heat-induced pain.

[0115] (3) The results are as follows: The results are as follows: The 1-day symptom improvement rate of patients in the application group (7 cases were significantly improved, with an improvement rate of 87.5%) and the control group (2 cases were improved, with an improvement rate of 25%). The 3-day symptom improvement rate of patients in the application group (8 cases were significantly improved, with an improvement rate of 100%) and the control group (4 cases were improved, with an improvement rate of 50%) were statistically significant (p < 0.05).

[0116] 4. Test group 4: heat stroke (body temperature > 38°C)

[0117] (1) Subject population

[0118] Patching group: 8 patients with heat stroke were placed in a cool place, hydrated and taken orally with Huoxiang Zhenqi water, and No. 1 or No. 2 cold compresses were applied to the patients' head, armpits, perineum, soles of feet and other parts for 6 to 8 hours to achieve local cooling.

[0119] Control group: 8 patients with heat stroke were placed in a cool place, hydrated and taken orally with Huoxiang Zhenqi water, and observed at all times.

[0120] (2) Evaluation of treatment efficacy

[0121] Record the patient's symptom improvement every 2 hours, mainly including changes in body temperature, dizziness, nausea, etc.

[0122] (3) The results are as follows:

[0123] The 2-hour symptom improvement rate of the patients was higher in the application group (6 cases were significantly improved, with an improvement rate of 75%) and higher in the control group (1 case was improved, with an improvement rate of 12.5%). The 8-hour symptom improvement rate of the patients was higher in the application group (8 cases were significantly improved, with an improvement rate of 100%) and higher in the control group (5 cases were improved, with an improvement rate of 62.5%), with statistically significant differences (p < 0.05).

[0124] 5. Test group 5: frostbite on soles of feet (ambient temperature < -25°C)

[0125] (1) Subject population

[0126] Patching group: 9 subjects used No. 3 / 4 hot compress on the soles of their feet before work (>8 hours / day), used it for two consecutive days, and removed it when returning to rest indoors.

[0127] Control group: 9 subjects did not use any treatment before work, worked more than 8 hours a day, and observed foot frostbite after 2 days.

[0128] The two groups of personnel work in the same environment and use the same kind of work shoes produced in the same batch by Factory 3515.

[0129] (2) Evaluation of treatment efficacy

[0130] Record the patient's daily frostbite conditions, including indoor skin warming, foot pain and numbness, local tissue redness and swelling, etc.

[0131] (3) The results are as follows:

[0132] The one-day symptom incidence of the subjects was as follows: the plaster group (0 cases, incidence rate 0%) and the control group (2 cases, incidence rate 22.2%); the two-day symptom incidence of the subjects was as follows: the plaster group (0 cases, incidence rate 0%) and the control group (4 cases, incidence rate 44.4%), which were statistically significant (p < 0.05).

[0133] 6. Test group 6: dysmenorrhea

[0134] (1) Subject population

[0135] Patching group: 7 patients with dysmenorrhea were treated with oral brown sugar ginger water and applied with a 3 / 4 hot compress patch to the abdomen daily for 10 to 12 hours each time for 5 consecutive days.

[0136] Control group: 7 patients with dysmenorrhea were treated with oral brown sugar ginger water and observed at any time.

[0137] (2) Evaluation of treatment efficacy

[0138] The daily treatment effect of the patients was evaluated starting from the first day of the menstrual period, mainly referring to the improvement of VAS scores of pain and pain on pressure, and whether nonsteroidal anti-inflammatory drugs were used for analgesia.

[0139] (3) The results are as follows: The improvement rates of menstrual symptoms in the application group (31 times of significant improvement, an improvement rate of 88.6%) and the control group (19 times of significant improvement, an improvement rate of 54.3%) were statistically significantly different (p < 0.05).

[0140] 7. Test group 7: children with high fever (>38.5℃)

[0141] (1) Subject population

[0142] Patching group: 6 children with high fever were placed in a cool place, hydrated, and applied No. 1 or No. 2 cold compresses to the patients' head, armpits, perineum, soles of feet, etc. for 6 to 8 hours to achieve local cooling.

[0143] Control group: 6 children with high fever were placed in a cool place, given hydration treatment, and observed at all times.

[0144] (2) Evaluation of treatment efficacy

[0145] The improvement of the patient's symptoms was recorded every 2 hours, mainly including changes in body temperature, dizziness, nausea, etc. All children whose symptoms were not controlled after 6 hours of treatment were treated with nonsteroidal anti-inflammatory drugs to reduce fever.

[0146] (3) The results are as follows:

[0147] The 2-hour symptom improvement rate of the patients was higher in the application group (5 cases were significantly improved, with an improvement rate of 83.3%) and higher in the control group (2 cases were improved, with an improvement rate of 33.3%). The 6-hour symptom improvement rate of the patients was higher in the application group (5 cases were significantly improved, with an improvement rate of 83.3%) and higher in the control group (4 cases were improved, with an improvement rate of 66.7%), with statistically significant differences (p < 0.05).

[0148] It can be seen from the above embodiments that the present invention provides a hydrogel cold compress patch and a hot and cold compress patch set and application prepared therefrom, wherein the hydrogel cold compress patch comprises the following raw materials in parts by weight: 26 to 65 parts of matrix component, 1.5 to 7 parts of cooling component, 0.54 to 2.06 parts of analgesic component, and 25.94 to 71.96 parts of water. The present invention provides a product that is easy to carry, suitable for early and acute emergency treatment, and can cope with disease treatment of various types of diseases. The use of the hydrogel cold compress patch can solve the problems of early cold compress treatment and moisturizing of burns and scalds, and soft tissue injuries, and can also cope with high temperature diseases such as high fever and heat stroke; the self-heating patch can solve the related problems of environmental hypothermia, frostbite, dysmenorrhea, and hot compress treatment of soft tissue injuries.

[0149] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A hydrogel cold compress, characterized in that: The hydrogel cold compress comprises the following raw materials in parts by weight: 26 to 65 parts of a matrix component, 1.5 to 7 parts of a cooling component, 0.54 to 2.06 parts of an analgesic component, and 25.94 to 71.96 parts of water.

2. The hydrogel cold compress according to claim 1, characterized in that: The matrix component comprises the following raw materials in parts by weight: 10 to 30 parts of hyaluronic acid, 10 to 20 parts of gelatin, 1 to 5 parts of silk protein, and 5 to 10 parts of glycerol.

3. The hydrogel cold compress according to claim 2, characterized in that: The cooling component comprises the following raw materials in parts by weight: 1 to 5 parts of borneol and 0.5 to 2 parts of water-soluble peppermint oil.

4. The hydrogel cold compress according to claim 3, characterized in that: The analgesic component comprises the following raw materials in parts by weight: 0.04-0.06 parts of cannabidiol and 0.5-2 parts of diclofenac sodium.

5. The method for preparing the hydrogel cold compress according to any one of claims 1 to 4, characterized in that: The steps include: (1) reacting 3-(4-benzylamino)-1,2,4,5-tetrazine with hyaluronic acid to obtain tetrazine-modified hyaluronic acid; (2) subjecting gelatin to an amidation reaction with succinic anhydride to obtain succinic anhydride-modified gelatin; (3) reacting 5-norbornene-2-methylamine with succinic anhydride-modified gelatin to obtain norbornene-modified gelatin; (4) mixing tetrazine-modified hyaluronic acid and norbornene-modified gelatin in proportion to generate a bioorthogonal reaction, and adding silk protein, glycerol, a cooling component, an analgesic component and water during the process to obtain a mixture; (5) After the mixture is solidified, a hydrogel cold compress is obtained.

6. Use of the hydrogel cold compress patch according to any one of claims 1 to 4 in the preparation of a hot and cold compress patch set.

7. A hot and cold compress set, characterized in that: The hot and cold compress set comprises the hydrogel cold compress and the self-heating compress according to any one of claims 1 to 4.

8. The hot and cold compress kit according to claim 7, characterized in that: The structure of the self-heating patch includes: a heat-generating inner core and an adhesive layer; The structure of the heat-generating inner core comprises in sequence: a skin-friendly non-woven fabric material, a heat-insulating layer containing 0.01 to 0.03% of Panax notoginseng Chinese herbal medicine ingredients, a heat-generating layer containing self-heating materials, and a heat-insulating layer; The adhesive layer is a skin-friendly tape.

9. The hot and cold compress kit according to claim 8, characterized in that: The hot and cold compress patch set includes 2 pairs of hydrogel cold compress patches and 2 pairs of self-heating patches.

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