A hydrogel patch and its production process

Abstract

The present invention belongs to the technical field of hydrogel patch production, and particularly relates to a hydrogel patch and its production process. The production process of the hydrogel patch of the present invention comprises the following steps: S1 Mix the hydrogel oil phase components evenly to obtain mixture A; S2 Mix a certain amount of deionized water with a prepolymer, heat and stir to dissolve, and add a photoinitiator after the solution cools down to room temperature, and stir to dissolve to obtain mixture B; S3 Mix the hydrogel water phase components evenly to obtain mixture C; S4 At a certain temperature, stir and make glue with mixture A, mixture B and mixture C; S5 Set an ultraviolet lamp beside the hydrogel coating equipment, and synchronously complete the coating process and the curing process; S6 Perform blanking in the workshop. The present invention adopts the ultraviolet light-initiated curing method to increase the crosslinking strength of the matrix, and the coating process and the curing process are carried out synchronously, greatly shortening the production time of the hydrogel, reducing the time interval with the blanking process, and significantly improving the production efficiency of the hydrogel patch.

Description

Technical Field

[0001] The present invention belongs to the technical field of hydrogel patch production, and particularly relates to a hydrogel patch and its production process. Background Art

[0002] The term "hydrogel" first appeared in 1960 and was named after polyhydroxyethyl methacrylate prepared by Wicherle and Lim in the Czech Republic. The unique structure of the hydrogel can provide an extracellular environment similar to human tissues and has good biocompatibility. A hydrogel patch is a topical transdermal drug delivery preparation made of a water-soluble polymer material as the main matrix, added with drugs, and processed through processes such as coating, curing, and blanking. In recent years, hydrogel patches have been widely used in fields such as drug-loaded sustained release, surgical dressings, and fever control, and have good clinical efficacy and market prospects.

[0003] Chinese Patent Application CN108853369A discloses a preparation method and application of a natural plant antibacterial liquid PAMs hydrogel patch. By weight components, the hydrogel patch includes: 15-45 parts of glycerol, 2-6 parts of NP-700, 0.2-0.6 parts of glycoll aluminum, 13.6-40.7 parts of distilled water, 0.1-0.3 parts of tartaric acid, 1.5-4.5 parts of azone, 1.5-4.5 parts of propylene glycol, 0.25-0.75 parts of SDS, and 15.85-47.5 parts of PAMs; the preparation method includes the following steps: S1, dispersing NP-700 and glycoll aluminum in glycerol under stirring conditions to form phase A; S2, dispersing tartaric acid, PAMs, azone, propylene glycol, and SDS in water under stirring conditions to form phase B; S3, then adding phase B to phase A, stirring evenly, placing it in an incubator, adjusting the temperature to 50 °C, incubating for 24 h, and then taking it out and standing at room temperature for 2 d to obtain the hydrogel patch. The preparation method of this hydrogel patch needs to be incubated at a temperature of 50 °C for 24 h and then stand at room temperature for 2 d to obtain. The production process of the hydrogel patch is divided into five major steps: oil-water mixing, stirring, coating, curing, and blanking. Curing is the rate-determining step. In current production, only after normal temperature curing for 10-24 hours can the next blanking process be carried out. The time span is too large and the production efficiency is low. Therefore, how to shorten the curing process duration and improve the production efficiency of hydrogel patches has become a key and common technical problem in this field. Summary of the Invention

[0004] Aiming at the deficiencies of the prior art, the purpose of the present invention is to provide a hydrogel patch and its production process. The present invention adopts ultraviolet light-induced curing to increase the cross-linking strength of the matrix, and the coating and curing processes are carried out synchronously, greatly shortening the production time of the hydrogel, reducing the time interval with the blanking process, and significantly improving the production efficiency of the hydrogel patch.

[0005] The technical solution of the present invention is as follows:

[0006] A production process of a hydrogel patch, comprising the following steps:

[0007] S1: According to the hydrogel formula, mix the hydrogel oil-phase components evenly to obtain mixture A;

[0008] S2: Mix a certain amount of deionized water with a prepolymer, heat and stir to dissolve. After the solution cools to room temperature, add a photoinitiator and stir to dissolve to obtain mixture B;

[0009] S3: According to the hydrogel formula, mix the hydrogel water-phase components evenly to obtain mixture C;

[0010] S4: At a certain temperature, stir and prepare the glue from mixture A obtained in step S1, mixture B obtained in step S2 and mixture C obtained in step S3, and it is required to be uniform without lack of glue;

[0011] S5: Set an ultraviolet lamp beside the hydrogel coating equipment, and complete the coating process and the curing process synchronously;

[0012] S6: Punch in the workshop to obtain the hydrogel patch.

[0013] Further, the prepolymer in step S2 is one of PEG200DA, PEG400DA, and PEG1000DA.

[0014] Further, the addition amount of the prepolymer in step S2 is 0.1%-5% of the mass of the hydrogel formula.

[0015] Further, in step S2, heat to 30-60°C.

[0016] Further, the photoinitiator in step S2 is 2-hydroxy-4-(2-hydroxyethoxy)-2-methylpropiophenone.

[0017] Further, the addition amount of the photoinitiator in step S2 is 0.1%-0.5% of the mass of the hydrogel formula.

[0018] Further, the hydrogel water-phase components in step S3 include a water-soluble pressure-sensitive adhesive emulsion.

[0019] Further, the addition amount of the water-soluble pressure-sensitive adhesive emulsion is 0.1-5% of the mass of the hydrogel formula.

[0020] Further, the ultraviolet light wavelength of the ultraviolet lamp in step S5 is 320-400nm, and the irradiation time of the ultraviolet lamp is 1-10min.

[0021] Another object of the present invention is to provide a hydrogel patch prepared by the production process of the hydrogel patch.

[0022] The present invention adopts the ultraviolet light-induced curing method, that is, using ultraviolet light as the energy source to initiate the rapid transformation of a chemically reactive hydrogel liquid solution into a solid state. Ultraviolet light (UV) is an electromagnetic radiation wave between the X-ray and visible light wavelength ranges, including three types: A, B, and C, ranging from 100 to 400 nm; when UV is used in industrial production, long-wave UV-A with a wavelength range of 320 - 400 nm is generally used internationally. The compound system for initiating curing consists of two main parts: prepolymer and photoinitiator. The prepolymer, also known as oligomer, is a general term for a class of high-molecular polymers with unsaturated double bonds. It is one of the main factors affecting the overall performance of photopolymerization products. The photoinitiator is an important component of the photopolymerized hydrogel, playing a key role in the efficiency of photopolymerization and also affecting the performance of photoinitiated hydrogels. The prepolymer of the present invention is one of PEG200DA (polyethylene glycol 200 diacrylate), PEG400DA (polyethylene glycol 400 diacrylate), and PEG1000DA (polyethylene glycol 1000 diacrylate). The photoinitiator of the present invention is 2-hydroxy-4-(2-hydroxyethoxy)-2-methylpropiophenone (Irgacure2959), which has good biocompatibility. Using the specific prepolymer and photoinitiator of the present invention can improve the efficiency of photopolymerization while making the overall performance of the obtained hydrogel more excellent.

[0023] Hydrogel patches used in transdermal drug delivery systems, surgical dressings, or the field of reducing fever need to have a certain adhesion performance to ensure that the hydrogel patch can be firmly applied to the body surface. Through a large number of studies, the present invention has found that if the ultraviolet light curing method is simply introduced into the production process of hydrogel patches, the adhesion performance of the hydrogel patches will be damaged. The present invention has conducted a large number of experimental studies and found that adding a certain proportion of water-soluble pressure-sensitive adhesive emulsion to the hydrogel formula can improve the adhesion performance of the hydrogel patch. However, it has been found that the addition of the water-soluble pressure-sensitive adhesive emulsion will have a certain impact on the mechanical properties and shear resistance of the hydrogel patch, which is not conducive to immediate die-cutting. Through a large number of creative experiments, it has been found that the addition of the specific water-soluble pressure-sensitive adhesive emulsion of the present invention can solve the problem of low production efficiency of hydrogel patches while maintaining the viscosity.

[0024] Compared with the prior art, the present invention has the following advantages:

[0025] (1) The present invention adopts the ultraviolet light-induced curing method to increase the cross-linking strength of the matrix, and the coating and curing processes are carried out simultaneously, greatly shortening the production time of the hydrogel, reducing the time interval between the die-cutting process, and significantly improving the production efficiency of the hydrogel patch.

[0026] (2) The present invention maintains the adhesion performance of the hydrogel patch while improving the production efficiency of the hydrogel. Detailed implementation manners

[0027] The present invention will be further described below through the description of specific implementation manners. However, this is not a limitation to the present invention. Those skilled in the art can make various modifications or improvements according to the basic idea of the present invention. As long as they do not depart from the basic idea of the present invention, they are within the scope of the present invention.

[0028] The raw materials used in the present invention are all commercially available unless otherwise specified.

[0029] Example 1: A hydrogel patch and its production process

[0030] The hydrogel formula includes the following components and their mass percentages: dipotassium glycyrrhizinate 0.005%, glycerol 10%, imidazolidinyl urea 0.01%, polyvinylpyrrolidone 0.5%, water-soluble pressure-sensitive adhesive emulsion 0.5% (Toyo Komy, ORIBAIN TM BPWHW-1), essence 0.0001%, pigment 0.0001%, prepolymer 2.5%, photoinitiator 0.147%, sodium polyacrylate with an average molecular weight of 2 million - 3 million 0.5%, sodium polyacrylate with an average molecular weight of 0.8 million - 1 million 0.5%, calcium sulfate 0.01%, deionized water 85.3278%; the prepolymer is PEG1000DA; the photoinitiator is 2-hydroxy-4-(2-hydroxyethoxy)-2-methylpropiophenone.

[0031] The production process of the hydrogel patch includes the following steps:

[0032] S1 According to the hydrogel formula, weigh dipotassium glycyrrhizinate, glycerol, imidazolidinyl urea, polyvinylpyrrolidone, essence, pigment (hydrogel oil-phase components), mix them evenly, stir for 4 minutes at a stirring speed of 30 Hz to obtain mixture A;

[0033] S2 Weigh 10% of deionized water, mix the deionized water with the prepolymer, heat it to 50°C, stir to dissolve, and add the photoinitiator after the solution cools to room temperature, stir to dissolve to obtain mixture B;

[0034] S3 According to the hydrogel formula, mix sodium polyacrylate with an average molecular weight of 2 million - 3 million, sodium polyacrylate with an average molecular weight of 0.8 million - 1 million, water-soluble pressure-sensitive adhesive emulsion, calcium sulfate and the remaining deionized water (hydrogel water-phase components) evenly, stir for 4 minutes at a stirring speed of 30 Hz to obtain mixture C;

[0035] S4 At a temperature of 20°C, stir and prepare the gel at 40 Hz for the mixture A obtained in step S1, the mixture B obtained in step S2, and the mixture C obtained in step S3;

[0036] S5 Set up an ultraviolet lamp beside the hydrogel coating equipment. The ultraviolet light wavelength of the ultraviolet lamp is 320 nm, and the irradiation time of the ultraviolet lamp is 1 min. The coating process and the curing process are completed synchronously;

[0037] S6 Perform die-cutting in the workshop to obtain the hydrogel patch.

[0038] Example 2. A hydrogel patch and its production process

[0039] The hydrogel formula includes the following components and their mass percentages: dipotassium glycyrrhizinate 0.005%, glycerol 10%, imidazolidinyl urea 0.01%, polyvinylpyrrolidone 0.5%, water-soluble pressure-sensitive adhesive emulsion 0.5% (Toyo Komy, ORIBAIN TM BPWHW-1), essence 0.0001%, pigment 0.0001%, prepolymer 2%, photoinitiator 0.14%, sodium polyacrylate with an average molecular weight of 2 million - 3 million 0.5%, sodium polyacrylate with an average molecular weight of 0.8 million - 1 million 0.5%, calcium sulfate 0.01%, deionized water 85.8348%; the prepolymer is PEG200DA; the photoinitiator is 2-hydroxy-4-(2-hydroxyethoxy)-2-methylpropiophenone.

[0040] The production process of the hydrogel patch includes the following steps:

[0041] S1 Weigh dipotassium glycyrrhizinate, glycerol, imidazolidinyl urea, polyvinylpyrrolidone, essence, pigment (hydrogel oil-phase components) according to the hydrogel formula, mix them evenly, and stir for 4 minutes at a stirring speed of 30 Hz to obtain mixture A;

[0042] S2 Weigh 10% of deionized water, mix the deionized water with the prepolymer, heat it to 30 °C, stir to dissolve, and add the photoinitiator after the solution cools to room temperature, then stir to dissolve to obtain mixture B;

[0043] S3 According to the hydrogel formula, mix sodium polyacrylate with an average molecular weight of 2 million - 3 million, sodium polyacrylate with an average molecular weight of 0.8 million - 1 million, water-soluble pressure-sensitive adhesive emulsion, calcium sulfate and the remaining deionized water (hydrogel water-phase components) evenly, and stir for 4 minutes at a stirring speed of 30 Hz to obtain mixture C;

[0044] S4 At a temperature of 20 °C, stir and mix mixture A obtained in step S1, mixture B obtained in step S2, and mixture C obtained in step S3 at 40 Hz to prepare the gel;

[0045] S5 Set up an ultraviolet lamp beside the hydrogel coating equipment. The ultraviolet light wavelength of the ultraviolet lamp is 320 nm, and the irradiation time of the ultraviolet lamp is 1 min. The coating process and the curing process are completed synchronously;

[0046] Blanking in Workshop S6 gives the hydrogel patch.

[0047] Example 3: A hydrogel patch and its production process

[0048] The hydrogel formula includes the following components and their mass percentages: dipotassium glycyrrhizinate 0.005%, glycerol 10%, imidazolidinyl urea 0.01%, polyvinylpyrrolidone 0.5%, water-soluble pressure-sensitive adhesive emulsion 0.8% (Toyo Komy, ORIBAIN TM BPWHW-1), essence 0.0001%, pigment 0.0001%, prepolymer 3%, photoinitiator 0.176%, sodium polyacrylate with an average molecular weight of 2 million - 3 million 0.5%, sodium polyacrylate with an average molecular weight of 0.8 million - 1 million 0.5%, calcium sulfate 0.01%, deionized water 84.4988%; the prepolymer is PEG400DA; the photoinitiator is 2-hydroxy-4-(2-hydroxyethoxy)-2-methylpropiophenone.

[0049] The production process of the hydrogel patch includes the following steps:

[0050] S1 Weigh dipotassium glycyrrhizinate, glycerol, imidazolidinyl urea, polyvinylpyrrolidone, essence, pigment (hydrogel oil-phase components) according to the hydrogel formula, mix evenly, stir for 4 minutes at a stirring speed of 30 Hz to obtain mixture A;

[0051] S2 Weigh 10% of deionized water, mix the deionized water with the prepolymer, heat to 50°C, stir to dissolve, and add the photoinitiator after the solution cools to room temperature, stir to dissolve to obtain mixture B;

[0052] S3 According to the hydrogel formula, mix sodium polyacrylate with an average molecular weight of 2 million - 3 million, sodium polyacrylate with an average molecular weight of 0.8 million - 1 million, water-soluble pressure-sensitive adhesive emulsion, calcium sulfate and the remaining deionized water (hydrogel water-phase components) evenly, stir for 4 minutes at a stirring speed of 30 Hz to obtain mixture C;

[0053] S4 At a temperature of 20°C, stir and mix mixture A obtained in step S1, mixture B obtained in step S2, and mixture C obtained in step S3 at 40 Hz to prepare the gel;

[0054] S5 Set up an ultraviolet lamp beside the hydrogel coating equipment, the ultraviolet light wavelength of the ultraviolet lamp is 320 nm, the irradiation time of the ultraviolet lamp is 1 min, and the coating process and the curing process are completed synchronously;

[0055] S6 Blanking in Workshop S6 gives the hydrogel patch.

[0056] Comparative Example 1: A hydrogel patch and its production process

[0057] The hydrogel formulation comprises the following components and their mass percentages: dipotassium glycyrrhizinate 0.005%, glycerol 10%, imidazolidinyl urea 0.01%, polyvinylpyrrolidone 0.5%, essence 0.0001%, pigment 0.0001%, sodium polyacrylate with an average molecular weight of 2 million - 3 million 0.5%, sodium polyacrylate with an average molecular weight of 0.8 million - 1 million 0.5%, calcium sulfate 0.01%, deionized water 88.4748%.

[0058] The production process of the hydrogel patch comprises the following steps:

[0059] S1 Weigh dipotassium glycyrrhizinate, glycerol, imidazolidinyl urea, polyvinylpyrrolidone, essence, pigment (hydrogel oil - phase components) according to the hydrogel formulation, mix them evenly, stir for 4 minutes at a stirring speed of 30 Hz to obtain mixture A;

[0060] S2 According to the hydrogel formulation, mix sodium polyacrylate with an average molecular weight of 2 million - 3 million, sodium polyacrylate with an average molecular weight of 0.8 million - 1 million, calcium sulfate and the remaining deionized water (hydrogel water - phase components) evenly, stir for 4 minutes at a stirring speed of 30 Hz to obtain mixture B;

[0061] S3 At a temperature of 20°C, stir - mix mixture A obtained in step S1 and mixture B obtained in step S2 at 40 Hz to prepare the gel;

[0062] S4 Coat the evenly - stirred hydrogel using a coater, and let it stand for 24 h after coating.

[0063] S5 Punch the semi - finished product in the workshop after standing to obtain the hydrogel patch.

[0064] Comparative Example 2: A hydrogel patch and its production process

[0065] The hydrogel formulation comprises the following components and their mass percentages: dipotassium glycyrrhizinate 0.005%, glycerol 10%, imidazolidinyl urea 0.01%, polyvinylpyrrolidone 0.5%, water - soluble pressure - sensitive adhesive emulsion 0.5% (Toyo Chemical Co., Ltd., ORIBAIN TM BPWHW - 1), essence 0.0001%, pigment 0.0001%, sodium polyacrylate with an average molecular weight of 2 million - 3 million 0.5%, sodium polyacrylate with an average molecular weight of 0.8 million - 1 million 0.5%, calcium sulfate 0.01%, deionized water 87.9748%.

[0066] The production process of the hydrogel patch comprises the following steps:

[0067] S1 Weigh dipotassium glycyrrhizinate, glycerin, imidazolidinyl urea, polyvinylpyrrolidone, essence, pigment (oil phase components of hydrogel), mix them evenly, stir for 4 minutes at a stirring speed of 30 Hz to obtain mixture A;

[0068] S2 According to the hydrogel formula, mix sodium polyacrylate with an average molecular weight of 2 million - 3 million, sodium polyacrylate with an average molecular weight of 0.8 million - 1 million, water - soluble pressure - sensitive adhesive emulsion, calcium sulfate and the balance of deionized water (aqueous phase components of hydrogel) evenly, stir for 4 minutes at a stirring speed of 30 Hz to obtain mixture B;

[0069] S3 At a temperature of 20 °C, stir - mix mixture A obtained in step S1 and mixture B obtained in step S2 at 40 Hz to prepare the gel;

[0070] S4 Coat the evenly - stirred hydrogel using a coater, and let it stand for 24 h after coating;

[0071] S5 Die - cut the semi - finished product in the workshop after standing to obtain the hydrogel patch.

[0072] Comparative Example 3: A hydrogel patch and its production process

[0073] The hydrogel formula includes the following components and their mass percentages: dipotassium glycyrrhizinate 0.005%, glycerin 10%, imidazolidinyl urea 0.01%, polyvinylpyrrolidone 0.5%, essence 0.0001%, pigment 0.0001%, prepolymer 2.5%, photo - initiator 0.147%, sodium polyacrylate with an average molecular weight of 2 million - 3 million 0.5%, sodium polyacrylate with an average molecular weight of 0.8 million - 1 million 0.5%, calcium sulfate 0.01%, deionized water 85.8278%; the prepolymer is PEG1000DA; the photo - initiator is 2 - hydroxy - 4-(2 - hydroxyethoxy)-2 - methylpropiophenone.

[0074] The production process of the hydrogel patch includes the following steps:

[0075] S1 Weigh dipotassium glycyrrhizinate, glycerin, imidazolidinyl urea, polyvinylpyrrolidone, essence, pigment (oil phase components of hydrogel), mix them evenly, stir for 4 minutes at a stirring speed of 30 Hz to obtain mixture A;

[0076] S2 Weigh 10% of deionized water, mix the deionized water with the prepolymer, heat it to 50 °C, stir to dissolve, and add the photo - initiator after the solution cools to room temperature, stir to dissolve to obtain mixture B;

[0077] S3 According to the hydrogel formula, mix sodium polyacrylate with an average molecular weight of 2 million - 3 million, sodium polyacrylate with an average molecular weight of 0.8 million - 1 million, calcium sulfate and the balance of deionized water (the hydrogel aqueous phase components) evenly, stir for 4 minutes at a stirring speed of 30 Hz to obtain mixture C;

[0078] S4 At a temperature of 20 °C, stir and make the gel of mixture A obtained in step S1, mixture B obtained in step S2 and mixture C obtained in step S3 at 40 Hz;

[0079] S5 Set up an ultraviolet lamp beside the hydrogel coating equipment. The ultraviolet light wavelength of the ultraviolet lamp is 320 nm, and the irradiation time of the ultraviolet lamp is 1 min. The coating process and the curing process are completed synchronously;

[0080] S6 Perform blanking in the workshop to obtain the hydrogel patch.

[0081] Comparative Example 4: A hydrogel patch and its production process

[0082] The hydrogel formula includes the following components and their mass percentages: dipotassium glycyrrhizinate 0.005%, glycerol 10%, imidazolidinyl urea 0.01%, polyvinylpyrrolidone 0.5%, YBJ-02 type medical acrylate emulsion pressure-sensitive adhesive 0.5% (Tangshan Huachang Medical Sanitary Dressing Industry Co., Ltd.), essence 0.0001%, pigment 0.0001%, prepolymer 2.5%, photoinitiator 0.147%, sodium polyacrylate with an average molecular weight of 2 million - 3 million 0.5%, sodium polyacrylate with an average molecular weight of 0.8 million - 1 million 0.5%, calcium sulfate 0.01%, deionized water 85.3278%; the prepolymer is PEG1000DA; the photoinitiator is 2-hydroxy-4-(2-hydroxyethoxy)-2-methylpropiophenone.

[0083] The production process of the hydrogel patch includes the following steps:

[0084] S1 According to the hydrogel formula, weigh dipotassium glycyrrhizinate, glycerol, imidazolidinyl urea, polyvinylpyrrolidone, essence, pigment (the hydrogel oil phase components), mix evenly, stir for 4 minutes at a stirring speed of 30 Hz to obtain mixture A;

[0085] S2 Weigh 10% of deionized water, mix the deionized water with the prepolymer, heat to 50 °C, stir and dissolve, and add the photoinitiator after the solution cools to room temperature, stir and dissolve to obtain mixture B;

[0086] S3 According to the hydrogel formula, mix sodium polyacrylate with an average molecular weight of 2 million to 3 million, sodium polyacrylate with an average molecular weight of 800,000 to 1 million, YBJ-02 pharmaceutical acrylate emulsion pressure-sensitive adhesive, calcium sulfate and the balance of deionized water (hydrogel aqueous phase components) evenly, stir for 4 minutes at a stirring speed of 30 Hz to obtain mixture C;

[0087] S4 At a temperature of 20 °C, stir and make the glue of mixture A obtained in step S1, mixture B obtained in step S2 and mixture C obtained in step S3 at 40 Hz;

[0088] S5 Set an ultraviolet lamp beside the hydrogel coating equipment. The ultraviolet light wavelength of the ultraviolet lamp is 320 nm, and the irradiation time of the ultraviolet lamp is 1 min. The coating process and the curing process are completed synchronously;

[0089] S6 Perform die-cutting in the workshop to obtain the hydrogel patch.

[0090] Experimental Example 1. Mechanical Property Characterization Experiment

[0091] The die-cutting process in the production of hydrogel patches needs to meet the die-cutting standard - the patch can be cut and there is no colloid residue on the tool, which requires a certain degree of curing of the gel. The tensile strength and elongation at break are used to characterize the curing degree of the hydrogel. Tensile strength refers to the stress at which the material produces the maximum uniform plastic deformation, which is determined by the mechanical strength of the molecular chain and reflects the cohesion of the hydrogel. The elongation at break macroscopically shows the "toughness" of the material and reflects the anti-shear performance of the hydrogel.

[0092] 1.1. Test method: Use a GBS electronic tensile machine with a probe in the shape of a clamp to perform vertical tensile testing on the hydrogel. Fix the sample with the probe, input the size of the sample and the distance between the clamps, and the tensile machine stretches the hydrogel sample at a tensile rate of 100 mm / min, and then the tensile strength and elongation at break of the material can be obtained.

[0093] 1.2. Test results: The test results are shown in Table 1.

[0094] Table 1: Test Results of Mechanical Properties

[0095] Sample Tensile strength Elongation at break Remarks Example 1 1.2 MPa 501％ The test sample is the patch in step S6 Comparative example 1 0.05 MPa 20％ The test sample is the patch in step S4 Comparative example 1 0.6 MPa 450％ The test sample is the patch in step S5 Comparative example 2 0.13 MPa 31％ The test sample is the patch in step S4 Comparative example 2 0.76 MPa 473％ The test sample is the patch in step S5 Comparative example 3 1.05 MPa 485％ The test sample is the patch in step S6 Comparative example 4 0.72 MPa 420％ The test sample is the patch in step S6

[0096] Note: When the test sample is the patch in step S4, it refers to the patch that has not been left standing after coating.

[0097] As can be seen from Table 1, the mechanical properties of the hydrogel patch obtained in Example 1 of the present invention are superior to those of the hydrogel patches obtained in Comparative Example 1, Comparative Example 2, Comparative Example 3, and Comparative Example 4. Moreover, the anti-shearing property is better than that of Comparative Example 1, Comparative Example 2, Comparative Example 3, and Comparative Example 4. In Comparative Example 1 and Comparative Example 2, the tensile strength and elongation at break of the patch in Step S4 are extremely low, and it cannot be blanked immediately, resulting in extremely low production efficiency. Under the same production conditions, the tensile strength and elongation at break of the hydrogel patch obtained in Example 1 of the present invention are also significantly higher than those of the hydrogel patch obtained in Comparative Example 4. This shows that the addition of the specific water-soluble pressure-sensitive adhesive emulsion of the present invention can improve the tensile strength and elongation at break of the hydrogel patch, and while maintaining adhesiveness, the mechanical properties and anti-shearing property of the hydrogel patch meet the requirements, solving the problem of low production efficiency of the hydrogel patch. In Example 1 of the present invention, coating and curing are carried out simultaneously, and the patch prepared in Step S6 can be blanked immediately. In addition, during the workshop blanking, it was found that the tool of Comparative Example 4 adhered with the hydrogel patch and residues. During the workshop blanking, there was no adhesion of the hydrogel patch and no residues on the tool of Example 1 of the present invention. Therefore, it meets the workshop blanking standard.

[0098] Experimental Example 2: Adhesion Experiment

[0099] 2.1. Test samples: The hydrogel patches obtained in Example 1, Comparative Example 1, and Comparative Example 3.

[0100] 2.2. Test method:

[0101] The hydrogels obtained in Example 1, Comparative Example 1, and Comparative Example 3, together with their intact packages, were pre-treated by placing them at 18°C to 25°C and a relative humidity of 40% to 70% for more than 2 h. According to the test method under the first method (determination of initial adhesion) of the adhesion determination method in Part IV of the Chinese Pharmacopoeia (2020 Edition), the adhesion of the hydrogel patch was detected, and the size of its initial adhesiveness was evaluated according to the largest ball number of steel balls that the sticky surface of the test sample could adhere to.

[0102] 2.3. Test results: The test results are shown in Table 2.

[0103] Table 2: Adhesion test results of the hydrogel

[0104] Sample The largest steel ball number that can adhere Example 1 32 Comparative example 1 25 Comparative example 3 18

[0105] As can be seen from Table 2, the largest steel ball number that the hydrogel patch prepared in Comparative Example 1 can adhere to is No. 25, and the largest steel ball number that the hydrogel patch prepared in Comparative Example 3 can adhere to is No. 18, indicating that simply introducing the ultraviolet curing method into the production process of the hydrogel patch will damage the adhesion performance of the hydrogel patch. The largest steel ball number that the hydrogel patch prepared in Example 1 of the present invention can adhere to is No. 32, indicating that adding a certain proportion of water-soluble pressure-sensitive adhesive emulsion to the hydrogel formulation can maintain adhesiveness while solving the problem of low production efficiency of the hydrogel patch.

[0106] Those skilled in the art should understand that the above embodiments are only illustrative of the principles and effects of the present invention, and are not intended to limit the present invention. Any person familiar with this technology can modify or change the above embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or changes completed by those with ordinary knowledge in the technical field without departing from the spirit and technical ideas disclosed by the present invention should still be covered by the claims of the present invention.

Claims

1. A production process of a hydrogel patch, characterized in that, It includes the following steps: S1. Mix the hydrogel oil phase components evenly to obtain mixture A; S2. Mix a certain amount of deionized water with the prepolymer, heat and stir to dissolve. After the solution cools to room temperature, add the photoinitiator and stir to dissolve to obtain mixture B; S3. Mix the hydrogel aqueous phase components and the remaining deionized water evenly to obtain mixture C; S4. At a certain temperature, stir and make the gel with mixture A obtained in step S1, mixture B obtained in step S2 and mixture C obtained in step S3, and it is required to be uniform without lack of gel; S5. Set up an ultraviolet lamp beside the hydrogel coating equipment, and the coating process and the curing process are completed synchronously; S6. Punch in the workshop to obtain the hydrogel patch; The hydrogel formula consists of hydrogel oil phase components, prepolymer, photoinitiator, hydrogel aqueous phase components and deionized water; The addition amount of the prepolymer described in step S2 is 0.1%-5% of the mass of the hydrogel formula; The prepolymer described in step S2 is one of PEG200DA, PEG400DA, PEG1000DA; The photoinitiator described in step S2 is 2-hydroxy-4-(2-hydroxyethoxy)-2-methylpropiophenone; The addition amount of the photoinitiator described in step S2 is 0.1%-0.5% of the mass of the hydrogel formula; The hydrogel oil phase components consist of dipotassium glycyrrhizinate, glycerol, imidazolidinyl urea, polyvinylpyrrolidone, essence and pigment, and the hydrogel aqueous phase components consist of sodium polyacrylate with an average molecular weight of 2-3 million, sodium polyacrylate with an average molecular weight of 0.8-1 million, water-soluble pressure-sensitive adhesive emulsion and calcium sulfate; The addition amount of the water-soluble pressure-sensitive adhesive emulsion is 0.1-5% of the mass of the hydrogel formula; The water-soluble pressure-sensitive adhesive emulsion is ORIBAIN™ BPW HW-1 of Toyo Kako; 2. The production process of the hydrogel patch according to claim 1, characterized in that, In step S2, heat to 30-60°C; 3. The production process of the hydrogel patch according to claim 1, characterized in that, In step S5, the ultraviolet light wavelength of the ultraviolet lamp is 320-400nm, and the irradiation time of the ultraviolet lamp is 1-10min; 4. The hydrogel patch prepared by the production process of the hydrogel patch according to any one of claims 1-3.