An ostomy base plate adhesive and a method of making the same

Abstract

The present application relates to the technical field of medical adhesive, and particularly relates to a stoma base plate adhesive and a preparation method thereof; the prior art has problems of insufficient adhesion stability in a wet environment and non-repeated adhesion; the present application is designed with a three-zone gradient function structure, including an inner ring zone close to the stoma, a middle ring zone for transition, and an outer ring zone in the periphery; the inner ring zone can resist the invasion of high-concentration exudate and maintain adhesion; the middle ring zone absorbs a small amount of exudate and realizes the repeated adhesion function through the heat response characteristics; the outer ring zone is mainly attached to the relatively dry skin surface to provide stable peripheral anchoring; meanwhile, the skin contact surface of the adhesive is constructed with a micropore array structure to significantly enhance the overall adhesion; the adhesive of the present application can maintain adhesion stability for a long time in a high-humidity exudation environment, is not prone to adhesion failure or spontaneous shedding, and can be repeatedly peeled off and reattached while maintaining good adhesion.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical adhesive, in particular to a stoma base plate adhesive and a preparation method thereof. BACKGROUND

[0002] Stoma patients need to fix the stoma bag on the abdominal skin, usually by medical adhesive on the stoma base plate to adhere to the skin around the stoma to collect exudates. Traditional stoma base plate usually uses hydrocolloid adhesive, which contains hydrophilic particles dispersed in a viscoelastic matrix, which can form a gel after absorbing a certain amount of exudate, thereby adhering to the skin and sealing the leakage.

[0003] However, when the stoma discharges a large amount of liquid, the base plate adhesive will swell rapidly after absorbing liquid, soften and lose adhesion, resulting in adhesion failure and spontaneous detachment of the device. The problem of insufficient adhesion stability in wet environment occurs in clinical practice; the skin barrier adhesion duration can be greatly shortened from the normal about 4 days to only 0.5 days when there is too much exudate, the main reason is that the exudate causes the adhesive to debond. The premature failure of the adhesive not only increases the burden of the patient due to frequent replacement of the base plate, but also may cause leakage to irritate the skin and cause skin inflammation. In addition, the adhesive of most existing stoma base plates is designed for one-time use and lacks repeatable adhesion performance. Once the user tears off the base plate, it is often difficult to reattach it to the original position after replacement or adjustment, because the surface of the traditional adhesive will be contaminated and the adhesion will be greatly reduced after removal, making it difficult to reattach firmly. Even if you try to reattach, the adhesion force usually decreases significantly, which cannot guarantee the sealing and fixation. This causes inconvenience in cases where the stoma needs to be checked repeatedly or adjusted in a short period of time.

[0004] In recent years, in order to reduce skin damage, some wound dressings and medical tapes have begun to use soft silicone gel adhesive, which causes less damage to the skin and can be reattached to a certain extent. However, the silicone gel adhesive itself does not have the ability to absorb liquid, and the pure silicone gel base plate is difficult to manage the absorption of stoma exudate, and direct use in stoma may pose a risk of leakage. In addition, researchers have developed biomimetic adhesives inspired by marine mussels. The catechol group in mussel foot silk protein can form hydrogen bonds, coordination bonds and other interactions with the substrate under wet conditions, thereby producing strong underwater adhesion. However, simply adding "mussel glue" components also brings new problems, such as the high activity of catechol which may affect the stability of the adhesive or cause the gel to be too cross-linked and brittle.

[0005] In summary, there is still a lot of room for improvement in the existing technology in terms of stoma base plate adhesive, and a new stoma base plate adhesive is urgently needed, which combines the use of multi-component compounding and structural innovation to achieve regional division of labor. SUMMARY

[0006] The application provides a stoma base plate adhesive and a preparation method thereof to overcome the defects of the stoma base plate adhesive in the prior art, i.e., easy peeling off in a wet environment and unrepeatable use. The adhesive realizes stable adhesion to the skin with exudate for a long time, can be repeatedly peeled off and reattached while maintaining adhesion, and thus improves the safety and convenience of stoma care.

[0007] The specific technical scheme is as follows:

[0008] The application provides a stoma base plate adhesive and a preparation method thereof, which are as follows:

[0009] S1: outer ring area material preparation.

[0010] S11: poly-caprolactone diol is reacted with excess diisocyanate, then hydroxyethyl methacrylate is added, a catalyst dibutyltin dilaurate is added dropwise, and a polyurethane acrylate prepolymer is prepared at 70 DEG C; the polyurethane acrylate prepolymer is dissolved in N, N-dimethylformamide solvent, dopamine hydrochloride is added under nitrogen protection, and stirring is conducted to prepare polydopamine grafted polyurethane acrylate.

[0011] S12: polyisobutylene, styrene-isoprene-styrene block copolymer, C5 petroleum resin and paraffin oil are masticated in a masticator; then carboxymethyl cellulose sodium, gelatin and antioxidant 1010 are added and continue to be masticated; then polydopamine grafted polyurethane acrylate is added, and mastication is conducted at 75 DEG C for 5 min to obtain a mixed glue; finally, the mixed glue is calendered and aged to obtain a continuous glue sheet.

[0012] S2: middle ring area material preparation, N-isopropyl acrylamide and N, N'-methylene bisacrylamide are dissolved in deionized water under light shielding condition, then furan functionalized gelatin is added, and stirring is conducted at 40-50 DEG C until complete dissolution; then the temperature is lowered to 30 DEG C, silica powder is added, mechanical stirring is conducted, and defoaming is conducted to prepare a middle ring area slurry.

[0013] S3: inner ring area material preparation, sulfobetaine methacrylate, acrylamide, N, N'-methylene bisacrylamide and a photoinitiator are completely dissolved in Tris-HCl buffer under light shielding and nitrogen-filled atmosphere; then dopamine hydrochloride is added, magnetic stirring is conducted until complete dissolution, and standing is conducted to obtain a colorless transparent solution.

[0014] S4: preparation of a reverse microstructure release film, surface corona treatment is conducted on a PET base film, then a release agent is coated and cured, a UV resin is coated and immediately contacted with a nickel template of a reverse micropore array, and finally UV curing, demolding and aging are conducted to obtain a reverse microstructure release film.

[0015] S5: The preparation process of the adhesive of the stoma base plate, the continuous adhesive film prepared in S1 is cut into concentric rings by a mold and placed on the reverse microstructure release film prepared above to obtain an outer ring zone adhesive ring; the middle ring zone slurry prepared in S2 is heated to 75°C and then injected into the middle ring zone of the outer ring zone adhesive ring, and cooled to room temperature; the colorless transparent solution prepared in S3 is injected into the inner ring zone, then a metal mask plate is covered on the product, only the inner ring zone is exposed, and irradiation is performed by using an ultraviolet light source. After preparation, a layer of polyethylene protective film is covered, and aging is performed to obtain the adhesive of the stoma base plate.

[0016] Further, the parameters of the internal mixer in S12 are set as follows: temperature 100°C, time length 15 min, and rotating speed 30 rpm.

[0017] The parameters of the continued internal mixing in S12 are set as follows: temperature 80°C, time length 10 min, and rotating speed 30 rpm.

[0018] The parameters of the calendering in S12 are set as follows: upper roller temperature 80°C, middle roller temperature 70°C, lower roller temperature 60°C, and nip 0.8 mm.

[0019] The parameters of the aging in S12 are set as follows: temperature 40°C, and time length 24 h.

[0020] Further, the parameters of the mechanical stirring in S2 are set as follows: rotating speed 2000 rpm, and time length 2 min.

[0021] The parameters of the defoaming in S2 are set as follows: vacuum degree -0.095 MPa, and time length 5 min.

[0022] Further, the parameters of the standing in S3 are set as follows: temperature 25°C, and time length 15 min.

[0023] Further, the parameters of the solidification in S4 are set as follows: temperature 120°C, and time length 1 min.

[0024] The parameters of the UV curing in S4 are set as follows: wavelength 395 nm, intensity 800 mW / cm 2 , and time length 2 s.

[0025] The parameters of the aging in S4 are set as follows: temperature 25°C, relative humidity 45%, and time length 24 h.

[0026] Further, the parameters of the irradiation in S5 are set as follows: wavelength 365 nm, intensity 5-15 mW / cm 2 , and time length 30-90 s.

[0027] The parameters of the aging in S5 are set as follows: temperature 40°C, and time length 24 h.

[0028] Compared with the prior art, the present application has the following beneficial effects:

[0029] 1. The present application provides targeted solutions for different regional challenges through three-zone gradient design, working synergistically to achieve globally optimal adhesion, sealing, absorption, and repeatable sticking performance.

[0030] 2. The present application ensures long-term adhesion stability in extreme wet environments and effectively prevents shedding through the use of mussel-inspired chemistry and zwitterionic anti-pollution strategies in the inner ring zone, combined with the physical adsorption of biomimetic microstructures.

[0031] 3. The present application enables multiple repositioning and sticking through simple cooling, greatly improving user experience and reducing waste, through the thermal reversibility of the middle ring zone. BRIEF DESCRIPTION OF DRAWINGS

[0032] Figure 1 is a preparation process flow chart of an ostomy base plate adhesive.

[0033] Figure 2 is a schematic diagram of the ostomy base plate adhesive finally prepared in Example 1: a is the outer ring zone: providing peripheral anchoring; b is the middle ring zone: absorbing a small amount of exudate and achieving repeatable sticking through thermal reversibility; c is the inner ring zone: resisting high-concentration exudate and preserving adhesion; d is the recessed structure.

[0034] Figure 3 is a comparison chart of initial adhesion, water absorption expansion rate, and peel strength data for the ostomy base plate adhesives finally prepared in Examples 1-4 and Comparative Examples 1-2. DETAILED DESCRIPTION

[0035] The following examples further explain and illustrate the technical solutions of the present application. It is particularly pointed out that each specific embodiment is a specific embodiment and explanation of the technical solution, and should not be regarded as a limitation on the scope of protection of the present application. Those skilled in the art still have the right to modify the technical solutions of these examples, to replace some or all of the technical features with equivalent alternatives, and these modifications or replacements do not change the essence of the corresponding technical solution, and do not make the essence of the corresponding technical solution deviate from the scope of the technical solution described in the present application.

[0036] The application provides an ostomy base adhesive and a preparation method thereof. A composite hydrogel is formed by a high proportion of mussel-inspired adhesive and a zwitterionic polymer in the inner ring area. The mussel-inspired adhesive contains a large number of catechol adhesion groups, which improves the adhesion stability in a wet environment. The zwitterionic polymer has excellent anti-biofouling performance and can form a hydration layer on the surface of the gel to hinder proteins. The middle ring area is prepared by using the properties of a thermoreversible hydrogel and microporous silica gel, so that the base can restore most of the adhesion after being removed under mild conditions, allowing slight adjustment of the position or reuse after cleaning. The outer ring area is prepared by using a moderately improved traditional hydrogel adhesive to provide peripheral support and anchoring of the base. The hydrogel adhesive can form a continuous and reliable adhesion on the skin surface. As shown in the accompanying Figure 1 figure, it is a preparation process of an ostomy base adhesive. The detailed technical scheme is as follows:

[0037] 1. Outer ring area material preparation

[0038] 1.1 Preparation of polydopamine grafted polyurethane acrylate

[0039] Poly-caprolactone diol is reacted with excess diisocyanate, then hydroxyethyl methacrylate is added, and a polyurethane acrylate prepolymer is prepared at 70 DEG C by dropwise adding a catalyst dibutyltin dilaurate. The polyurethane acrylate prepolymer is dissolved in N, N-dimethylformamide solvent, and dopamine hydrochloride is added under nitrogen protection, and stirring is performed to prepare polydopamine grafted polyurethane acrylate.

[0040] 1.2 Raw material quality ratio

[0041] PIB (polyisobutylene) 40 parts, styrene-isoprene-styrene block copolymer 20 parts, C5 petroleum resin 15-25 parts, polydopamine grafted polyurethane acrylate 5-10 parts, sodium carboxymethyl cellulose 10-20 parts, gelatin 5-15 parts, paraffin oil 8-20 parts, and antioxidant 1010 0.5-1.5 parts are used as the benchmark.

[0042] 1.3 Preparation

[0043] PIB, styrene-isoprene-styrene block copolymer, C5 petroleum resin and paraffin oil are low-temperature milled in a banbury mixer to avoid degradation of the styrene-isoprene-styrene block copolymer. Then sodium carboxymethyl cellulose, gelatin and antioxidant 1010 are added and continue to be milled to prevent the hydrogel from pre-gelatinizing. Then polydopamine grafted polyurethane acrylate is added and milled at 75 DEG C for 5 min to protect the catechol active group by low-temperature short-time processing. The mixed rubber is obtained. Finally, the mixed rubber is calendered and aged to obtain a continuous rubber sheet. Calendering avoids the generation of bubbles, and aging improves the stability of adhesion.

[0044] 2. Middle ring area material preparation

[0045] 2.1 Material quality ratio

[0046] Take N-isopropyl acrylamide 20 parts, N,N'-methylene bisacrylamide 0.2 parts as the basis, furan functionalized gelatin 3-8 parts, diphenylmethane bismaleimide crosslinking agent 1-3 parts, silica powder 10-30 parts, deionized water 50-70 parts.

[0047] 2.2 Preparation

[0048] Under the condition of light shielding, N-isopropyl acrylamide and N,N'-methylene bisacrylamide are dissolved in deionized water, then furan functionalized gelatin is added, and stirring is carried out at 40-50℃ until complete dissolution; then the temperature is lowered to 30℃, silica powder is added, and mechanical stirring is carried out at 30℃ to prevent premature polymerization of N-isopropyl acrylamide at high temperature, and defoaming is carried out to prepare the middle ring area slurry, wherein mechanical stirring realizes high-precision, bubble-free mixing to ensure the uniformity of the slurry, and defoaming is carried out because the slurry has high viscosity and the silica powder is a porous material that easily traps bubbles, and defoaming treatment must be carried out, otherwise the compactness and appearance of the final gel will be affected.

[0049] 3. Preparation of inner ring area material

[0050] 3.1 Material quality ratio

[0051] Take sulfobetaine methacrylate (SBMA) 25 parts, dopamine hydrochloride 1 part, and acrylamide 8 parts as the basis, N,N'-methylene bisacrylamide 0.1-0.3 parts, photoinitiator 0.1-0.3 parts, and Tris-HCl buffer 60-70 parts (pH 8.5, 0.1 mol / L).

[0052] 3.2 Preparation

[0053] In a light-shielded, nitrogen-filled atmosphere, sulfobetaine methacrylate, acrylamide, N,N'-methylene bisacrylamide, and photoinitiator are completely dissolved in Tris-HCl buffer. In this alkaline environment, dissolved oxygen can initiate the slow oxidation of dopamine to generate quinone active intermediates and their oligomers. Then dopamine hydrochloride is added and magnetically stirred until complete dissolution, and then left to stand to obtain a colorless transparent solution, ensuring that dopamine is effectively covalently incorporated into the polymer network.

[0054] 4. Preparation of reverse microstructure release film

[0055] 4.1 Preparation

[0056] The PET base film is subjected to surface corona treatment to increase its surface tension; then coated with a release agent, solidified to achieve clean peeling; then coated with a UV resin and immediately contacted with a nickel template of reverse micro-hole array, and finally UV solidified, demolded and aged to obtain a reverse microstructure release film.

[0057] 5. Ostomy wafer adhesive preparation process

[0058] 5.1 Preparation of outer ring area

[0059] The continuous film prepared above is cut into concentric rings with a mold and placed on the reverse microstructure release film prepared above.

[0060] 5.2 Filling the middle ring area

[0061] The middle ring area slurry prepared above is heated to 75℃, then injected into the middle ring area position in the outer ring area rubber ring, and cooled to room temperature.

[0062] 5.3 Preparation of filling inner ring area

[0063] The colorless transparent solution prepared above is injected into the inner ring area, then a metal mask is overlaid on the product, only the inner ring area is exposed, and irradiated with a UV light source to cause copolymerization and crosslinking reaction of the inner ring area material to form a firm gel network. After preparation, a layer of polyethylene protective film is covered, and aged to obtain an ostomy wafer adhesive.

[0064] Example 1

[0065] A preparation method of an ostomy wafer adhesive is as follows:

[0066] Table 1: Main raw materials

[0067]

[0068]

[0069]

[0070] S1: Preparation of outer ring area material.

[0071] S11: Poly (caprolactone) diol is reacted with excess diisocyanate, then hydroxyethyl methacrylate is added, and a catalyst dibutyltin dilaurate is added dropwise to prepare a polyurethane acrylate prepolymer at 70℃; the polyurethane acrylate prepolymer is dissolved in N,N-dimethylformamide solvent, and dopamine hydrochloride is added under nitrogen protection, and stirred to prepare a polydopamine grafted polyurethane acrylate.

[0072] S12: The polyisobutylene, styrene-isoprene-styrene block copolymer, C5 petroleum resin and paraffin oil are mixed in an internal mixer, wherein the mixing parameters are set as follows: temperature 100℃, time 15 min, and rotating speed 30 rpm. Then sodium carboxymethyl cellulose, gelatin and antioxidant 1010 are added and mixed, wherein the mixing parameters are set as follows: temperature 80℃, time 10 min, and rotating speed 30 rpm. Then polydopamine grafted polyurethane acrylate is added and mixed at 75℃ for 5 min to obtain a mixed rubber. Finally, the mixed rubber is calendered and aged to obtain a continuous rubber sheet, wherein the calendering parameters are set as follows: upper roller temperature 80℃, middle roller temperature 70℃, lower roller temperature 60℃, and nip 0.8 mm; the aging parameters are set as follows: temperature 40℃, and time 24 h; based on 40 parts of polyisobutylene, 20 parts of styrene-isoprene-styrene block copolymer, 20 parts of C5 petroleum resin, 8 parts of polydopamine grafted polyurethane acrylate, 15 parts of sodium carboxymethyl cellulose, 10 parts of gelatin, 14 parts of paraffin oil, and 1 part of antioxidant 1010.

[0073] S2: Preparation of the middle annulus material, N-isopropyl acrylamide and N,N'-methylene bisacrylamide are dissolved in deionized water under light shielding condition, then furan functionalized gelatin is added, and stirred at 45℃ until completely dissolved; then cooled to 30℃, silica powder is added, mechanically stirred, and degassed to obtain a middle annulus slurry, wherein the mechanical stirring parameters are set as follows: rotating speed 2000 rpm, and time 2 min; the degassing parameters are set as follows: vacuum degree -0.095 MPa, and time 5 min; based on 20 parts of N-isopropyl acrylamide, 0.2 parts of N,N'-methylene bisacrylamide, 6 parts of furan functionalized gelatin, 2 parts of diphenylmethane bismaleimide crosslinking agent, 20 parts of silica powder, and 60 parts of deionized water.

[0074] S3: Preparation of the inner annulus material, sulfobetaine methacrylate, acrylamide, N,N'-methylene bisacrylamide and photoinitiator are completely dissolved in Tris-HCl buffer under light shielding and nitrogen atmosphere; then dopamine hydrochloride is added, magnetically stirred until completely dissolved, and left to stand, wherein the standing parameters are set as follows: temperature 25℃, and time 15 min, to obtain a colorless transparent solution; based on 25 parts of sulfobetaine methacrylate (SBMA), 1 part of dopamine hydrochloride, 8 parts of acrylamide, 0.2 parts of N,N'-methylene bisacrylamide, 0.2 parts of photoinitiator, and 65 parts of Tris-HCl buffer (pH 8.5, 0.1 mol / L).

[0075] S4: Preparation of reverse microstructure release film, surface corona treatment is performed on the PET base film, then coated with release agent, solidified, coated with UV resin and immediately contacted with the nickel template of reverse micro-pore array, and finally UV cured, demolded, and aged to obtain the reverse microstructure release film, wherein the curing parameters are set as: temperature 120℃, time 1min, UV curing parameters are set as: wavelength 395nm, intensity 800mW / cm 2 , time 2s, and aging parameters are set as: temperature 25℃, relative humidity 45%, time 24h.

[0076] S5: Preparation process of ostomy base adhesive, the continuous film prepared in S1 is cut into concentric rings with a mold and placed on the reverse microstructure release film prepared above to obtain an outer ring zone adhesive ring; the middle ring zone paste prepared in S2 is heated to 75℃, then injected into the middle ring zone position in the outer ring zone adhesive ring, and cooled to room temperature; the colorless transparent solution prepared in S3 is injected into the inner ring zone, then a metal mask is covered on the product, only the inner ring zone is exposed, and irradiated with a UV light source. After preparation, a layer of polyethylene protective film is covered, and aged to obtain the ostomy base adhesive, wherein the irradiation parameters are set as: wavelength 365nm, intensity 10mW / cm 2 , time 60s, and aging parameters are set as: temperature 40℃, time 24h. Figure 2 is a schematic diagram of the ostomy base adhesive: a is the outer ring zone: providing peripheral anchoring; b is the middle ring zone: absorbing a small amount of exudate and realizing repeatable adhesion through thermal reversibility; c is the inner ring zone: resisting high concentration of exudate and preserving adhesion; d is the recessed structure.

[0077] Example 2

[0078] Referring to the composition and preparation process of Example 1, the difference is that:

[0079] In the preparation process of S12, 15 parts of C5 petroleum resin, 5 parts of polydopamine grafted polyurethane acrylate, 10 parts of sodium carboxymethyl cellulose, 5 parts of gelatin, 8 parts of paraffin oil, and 0.5 parts of antioxidant 1010 are used, and the other components are the same.

[0080] In the preparation process of S2, the furan functionalized gelatin is stirred at 40℃ until completely dissolved, and the other steps are the same.

[0081] In the preparation process of S2, 3 parts of furan functionalized gelatin, 1 part of diphenylmethane bismaleimide crosslinking agent, and 10 parts of silica powder are used, and the other components are the same.

[0082] In the preparation process of S3, 0.1 parts of N,N'-methylene bisacrylamide and 0.1 parts of photoinitiator are used, and the other components are the same.

[0083] The irradiation intensity in S5 of the preparation process is 5 mW / cm 2 , the irradiation time is 30 s, and the other steps are the same.

[0084] Example 3

[0085] Referring to the composition and preparation process of Example 1, the difference is that:

[0086] In S12 of the preparation process, 25 parts of C5 petroleum resin, 10 parts of polydopamine grafted polyurethane acrylate, 20 parts of sodium carboxymethyl cellulose, 15 parts of gelatin, 20 parts of paraffin oil, 1.5 parts of antioxidant 1010, and the same other components.

[0087] In S2 of the preparation process, furan functionalized gelatin is stirred at 50°C until completely dissolved, and the other steps are the same.

[0088] In S2 of the preparation process, 8 parts of furan functionalized gelatin, 3 parts of diphenylmethane bismaleimide crosslinking agent, 30 parts of silica powder, and 70 parts of deionized water, and the same other components.

[0089] In S3 of the preparation process, 0.3 parts of N,N'-methylene bisacrylamide, 0.3 parts of photoinitiator, and 70 parts of Tris-HCl buffer, and the same other components.

[0090] In S5 of the preparation process, the irradiation intensity is 15 mW / cm 2 , the irradiation time is 90 s, and the other steps are the same.

[0091] Example 4

[0092] Referring to the composition and preparation process of Example 1, the difference is that:

[0093] In S12 of the preparation process, 18 parts of C5 petroleum resin, 9 parts of polydopamine grafted polyurethane acrylate, 12 parts of sodium carboxymethyl cellulose, 13 parts of gelatin, 10 parts of paraffin oil, and 0.9 parts of antioxidant 1010, and the same other components.

[0094] In S2 of the preparation process, furan functionalized gelatin is stirred at 40°C until completely dissolved, and the other steps are the same.

[0095] In S2 of the preparation process, 4 parts of furan functionalized gelatin, 1.5 parts of diphenylmethane bismaleimide crosslinking agent, 25 parts of silica powder, and 65 parts of deionized water, and the same other components.

[0096] In S3 of the preparation process, 0.15 parts of N,N'-methylene bisacrylamide, 0.25 parts of photoinitiator, and 63 parts of Tris-HCl buffer, and the same other components.

[0097] In S5 of the preparation process, the irradiation intensity is 13 mW / cm 2, irradiation time 45 s, and the other steps are the same.

[0098] Comparative Example 1

[0099] Referring to the composition and preparation process of Example 1, the difference is that:

[0100] In S4 of the preparation process, the biomimetic microstructure release film is deleted, and a smooth release film is used instead, and the other steps are the same.

[0101] Comparative Example 2

[0102] Referring to the composition and preparation process of Example 1, the difference is that:

[0103] In S5 of the preparation process, the partition preparation is deleted, and the material is prepared by mixing all together, and the other steps are the same.

[0104] Examples 1-4 and Comparative Examples 1-2, the final prepared ostomy base adhesive was sampled, and the initial adhesion, peel strength and repeatable sticking times test was carried out, referring to the standard GB / T 2792-2014 "Test method for peel strength of adhesive tape".

[0105] Examples 1-4 and Comparative Examples 1-2, the final prepared ostomy base adhesive was sampled, and the wet environment adhesion time test was carried out, referring to the standard GB / T 4851 "Test method for pressure sensitive adhesive tape holding adhesion".

[0106] Examples 1-4 and Comparative Examples 1-2, the final prepared ostomy base adhesive was sampled, and the water absorption swelling rate test was carried out, referring to the standard GB / T 20405.5-2025 "Incontinence urine absorbent polyacrylate superabsorbent powder Part 5: Determination of water absorption rate in salt solution by weighing method".

[0107] The specific test results are shown in Table 2, Figure 3

[0108] Table 2 Comparison of core performance of Examples 1-4 and Comparative Examples 1-2

[0109]

[0110] ​From the above comparison results, it can be seen that the comprehensive performance of Example 1 is the best, and the polydopamine grafted polyurethane acrylate provides wet adhesion; sodium carboxymethyl cellulose and gelatin form an efficient water absorption and water locking network, which can manage the liquid permeation without excessive swelling leading to failure, and the partition design ensures strong adhesion of the outer ring, water absorption and buffering of the middle ring, and biocompatibility of the inner ring, maximizing the synergistic effect, which shows that Example 1 successfully solves the problems of poor adhesion stability in wet environment and insufficient repeatable adhesion performance; the amount of some components in Example 2 is reduced, resulting in a slight decrease in wet adhesion and cohesion, a shorter adhesion time, and a decrease in repeatable adhesion times by one time; the amount of some components in Example 3 is increased, resulting in a slight increase in water absorption and swelling rate, which may cause local pressure increase and affect the adhesion time in wet environment; the parameters of Example 4 are randomly selected between the intermediate values, and the performance is still excellent, but it does not reach the best balance point of Example 1; the comprehensive performance of Examples 2 to 4 is slightly lower than that of Example 1, which shows that excellent adsorption effect is still achieved under a large range of parameter changes; Comparative Example 1 uses a smooth release film, and the surface of the colloid is flat, the repeatable adhesion times are sharply reduced to only 2 times, because the flat surface is irreversibly deformed and cohesive failure occurs during the first peeling, and the wet adhesion is also reduced, because the lack of microstructure anchoring effect makes it more prone to overall slip and fall under liquid infiltration; Comparative Example 2 mixes all functional materials, and the initial adhesion is very low, because the strong adhesion system and the hydrophilic gel system are incompatible, forming a defective interface, the water absorption and swelling rate is extremely high and cannot be controlled, leading to rapid disintegration of the material structure. The adhesion time is very short, and the material cannot be effectively adhered.

[0111] In summary, through the above examples and comparative examples, it can be clearly seen that the ostomy disc adhesive provided by the present application is significantly better than the traditional scheme in terms of initial adhesion, wet environment adhesion time, water absorption and swelling rate, and repeatable adhesion times, which is due to the optimized material formula, innovative polydopamine grafting technology, biomimetic microstructure surface, and core partition structure design, thereby solving the problems of poor adhesion stability in wet environment and insufficient repeatable adhesion performance.

Claims

1. An ostomy base adhesive, characterized in that: the ostomy base adhesive is composed of an inner ring zone adjacent to the stoma, a middle ring zone in the middle and an outer ring zone in the periphery, and the adhesive contact surface has a biomimetic microstructure that can generate negative pressure to assist adsorption and enhance overall adhesion when attached to the skin; the inner ring zone can resist high-concentration exudate invasion and maintain adhesion; the middle ring zone can absorb a small amount of exudate while realizing the function of repeated adhesion; the outer ring zone is attached to the relatively dry skin surface to provide stable peripheral anchoring; the inner ring zone is formed by a mussel biomimetic adhesive and a zwitterionic polymer into a composite hydrogel; the middle ring zone is an interpenetrating network layer formed by a thermoreversible hydrogel and a microporous silica gel; and the outer ring zone is a modified hydrocolloid adhesive layer.

2. The ostomy base adhesive according to claim 1, characterized in that: the inner ring zone is prepared with the following specific raw materials: 25 parts of sulfobetaine methacrylate, 1 part of dopamine hydrochloride and 8 parts of acrylamide as the base, 0.1-0.3 parts of N,N'-methylenebisacrylamide, 0.1-0.3 parts of a photoinitiator and 60-70 parts of Tris-HCl buffer.

3. The ostomy base adhesive according to claim 1, characterized in that: the middle ring zone is prepared with the following specific raw materials: 20 parts of N-isopropyl acrylamide and 0.2 parts of N,N'-methylenebisacrylamide as the base, 3-8 parts of furan-functionalized gelatin, 1-3 parts of a diphenylmethane bismaleimide crosslinking agent, 10-30 parts of silica gel powder and 50-70 parts of deionized water.

4. The ostomy base adhesive according to claim 1, characterized in that: the hydrocolloid adhesive layer is prepared with the following specific raw materials: 40 parts of polyisobutylene and 20 parts of a styrene-isoprene-styrene block copolymer as the base, 15-25 parts of a C5 petroleum resin, 5-10 parts of polydopamine grafted polyurethane acrylate, 10-20 parts of sodium carboxymethyl cellulose, 5-15 parts of gelatin, 8-20 parts of paraffin oil and 0.5-1.5 parts of antioxidant 1010.

5. The ostomy base adhesive according to claim 1, characterized in that: the biomimetic microstructure is composed of micron-level semicircular pits, and each pit is separated from each other by a micro channel to discharge air and form negative pressure and enhance air permeability when attached. including the following steps: S1: outer ring zone material preparation; S11: polyurethane acrylate prepolymer is prepared by reacting polycaprolactone diol with excess diisocyanate, then adding hydroxyethyl methacrylate, and dropping catalyst dibutyltin dilaurate at 70°C; the polyurethane acrylate prepolymer is dissolved in N,N-dimethylformamide solvent, and dopamine hydrochloride is added under nitrogen protection, and stirred to prepare polydopamine grafted polyurethane acrylate; ​ ​ 6. The method of claim 1-5, wherein the adhesive is prepared by the steps of: ​ ​ ​ S12: The polyisobutylene, styrene-isoprene-styrene block copolymer, C5 petroleum resin and paraffin oil are mixed in an internal mixer; then sodium carboxymethyl cellulose, gelatin and antioxidant 1010 are added and mixed; then polydopamine grafted polyurethane acrylate is added and mixed at 75℃ for 5 min to obtain a mixed rubber; and finally the mixed rubber is calendered and aged to obtain a continuous rubber sheet; S2: The preparation of the middle ring region material, N-isopropyl acrylamide and N,N'-methylene bisacrylamide are dissolved in deionized water under light protection, then furan functionalized gelatin is added, and stirring is performed at 40-50℃ until complete dissolution; then the temperature is lowered to 30℃, silica powder is added, mechanical stirring is performed, and defoaming is performed to obtain a middle ring region slurry; S3: The preparation of the inner ring region material, sulfobetaine methacrylate, acrylamide, N,N'-methylene bisacrylamide and a photoinitiator are completely dissolved in a Tris-HCl buffer under light protection and in a nitrogen atmosphere; then dopamine hydrochloride is added and magnetically stirred until complete dissolution, and then the solution is left to stand to obtain a colorless transparent solution; S4: The preparation of a reverse microstructure release film, a PET base film is subjected to surface corona treatment, then a release agent is coated and cured, then a UV resin is coated and immediately contacted with a nickel template of a reverse microhole array, and finally UV curing, demolding and aging are performed to obtain a reverse microstructure release film; S5: The preparation process of the ostomy base plate adhesive, the continuous rubber sheet prepared in S1 is cut into concentric circles using a mold and placed on the reverse microstructure release film prepared in S4 to obtain an outer ring region rubber ring; the middle ring region slurry prepared in S2 is heated to 75℃ and then injected into the middle ring region of the outer ring region rubber ring and cooled to room temperature; the colorless transparent solution prepared in S3 is injected into the inner ring region, then a metal mask is overlaid on the product, only the inner ring region is exposed, and then ultraviolet light is used for irradiation; after preparation, a layer of polyethylene protective film is overlaid, and aging is performed to obtain an ostomy base plate adhesive.

7. The preparation method of the ostomy base plate adhesive according to claim 6, wherein: the mixing in S12 is performed at a temperature of 100℃ for 15 min at a speed of 30 rpm; the continued mixing in S12 is performed at a temperature of 80℃ for 10 min at a speed of 30 rpm; the calendering in S12 is performed at an upper roller temperature of 80℃, a middle roller temperature of 70℃, a lower roller temperature of 60℃ and a nip of 0.8 mm; and the aging in S12 is performed at a temperature of 40℃ for 24 h.

8. The preparation method of the ostomy base plate adhesive according to claim 6, wherein: the defoaming in S2 is performed at a vacuum degree of-0.095 MPa for 5 min; and the standing in S3 is performed at a temperature of 25℃ for 15 min.

9. The preparation method of the ostomy base plate adhesive according to claim 6, wherein: the curing in S4 is performed at a temperature of 120℃ for 1 min; and the aging in S4 is performed at a temperature of 25℃, a relative humidity of 45% and for 24 h. ​ ​ ​ ​ ​ ​ ​ UV curing as described in S4, with the following parameters: wavelength 395 nm, intensity 800 mW / cm2, duration 2 s 2 , duration 2 s ​ 10. The method of claim 6, wherein the method further comprises: S5, aging, wherein the aging is performed at a temperature of 40°C for 24 hours. S5, parameters: wavelength 365 nm, intensity 5-15 mW / cm 2 , duration 30-90 s; ​

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