Antibacterial hydrocolloid dressing with temperature-controllable initial adhesion and peel strength, preparation method of antibacterial hydrocolloid dressing and ostomy bag

Abstract

The invention discloses an antibacterial hydrocolloid dressing with temperature-controllable initial adhesion and peel strength, a preparation method of the antibacterial hydrocolloid dressing and an ostomy bag. The preparation method comprises the following steps: sequentially adding polyethylene glycol diacrylate, polytetrahydrofuran diacrylate, polycaprolactone diacrylate, hyperbranched polylysine, a photoinitiator and a cross-linking agent into a solvent, uniformly mixing, pouring into a mold, carrying out ultraviolet curing, and drying to obtain the temperature response antibacterial material. 5-20 parts by mass of the temperature response antibacterial material, 20-50 parts by mass of a thermoplastic elastomer and 20-50 parts by mass of hydrophilic polymer particles are placed in an internal mixer to be uniformly mixed and cooled, and a hydrocolloid layer is obtained; and coating the hydrocolloid layer on a polyurethane film, covering glassine paper, putting the polyurethane film in a plate vulkameter, heating until the polyurethane film is molten, and carrying out punch forming at 10-20MPa to obtain the hydrocolloid dressing. The dressing can be used as an ostomy bag plastic tray, the peel strength of the dressing on the skin of a patient is regulated and controlled by controlling the temperature change, and the dressing has good antibacterial and corrosion-resistant performance.

Description

Technical Field

[0001] The present invention belongs to the field of medical materials, and particularly relates to an antibacterial hydrocolloid dressing with temperature-adjustable initial adhesion and peel strength, a preparation method thereof, and a stoma bag. Background Art

[0002] After stoma surgery, various problems will be encountered, and the most serious one is the sticking problem of the adhesive disc. Especially near the ileostomy, the excrement is thin, large in quantity, irregular, and contains digestive enzymes. Once the chassis is not firmly adhered, leakage will occur, and the excrement will irritate the skin around the stoma, causing dermatitis problems of varying degrees. If the adhesion of the chassis is too strong, it will also cause excessive tearing of the skin during replacement, resulting in pain and skin damage, and the residual glue is not easy to clean. Another problem is the corrosion resistance of the chassis: when the chassis absorbs the moisture in the skin sweat and stoma excrement and is continuously stimulated and corroded by the excrement, the adhesive around the central hole of the chassis gradually spreads, and foaming and dissolution, and sol phenomenon will occur after absorption saturation. At this time, it is easy to have gaps between the chassis and the skin and residual excrement moisture. If the liquid is not cleaned in time and the adhesive disc is not replaced in time, it will corrode the skin, resulting in phenomena such as redness, small rashes, itching or ulceration. Skin problems will directly affect stoma wearing, leading to continuous leakage and worsening of skin problems, which has a significant impact on the daily life of stoma patients. Therefore, it is very important to modify the existing hydrocolloid material of the stoma bag adhesive disc to improve the initial adhesion, peel strength and corrosion resistance of the hydrocolloid, and at the same time, it should be easy to replace, which is very important for the clinical effectiveness and patient comfort of stoma bag use.

[0003] When modifying the antibacterial property of hydrocolloid, inorganic antibacterial agents or water-soluble cationic compounds (such as polyquaternary ammonium salts, polyphosphonium salts, polyacrylamides, polybiguanides, polyethyleneimines, polylysines, etc.) or metal ions and oxides are usually added to the hydrocolloid dressing. Although these methods have good antibacterial effects, they also have limitations. For example, inorganic antibacterial agents such as silver-, copper- or zinc-loaded release antibacterial metal ions (Ag + , Cu 2+ or Zn 2+ ) or their nanoparticles act on bacteria on the dressing surface to achieve antibacterial. However, the continuous release and accumulation of antibacterial metal ions or nanoparticles may interfere with the normal growth of cells, resulting in an increase in the content of reactive oxygen species, producing cytotoxicity, and then causing skin allergies, itching or pigment deposition. In addition, water-soluble cationic compounds usually have high cytotoxicity and may cause irritation and damage to the skin. Moreover, these modification methods mainly focus on antibacterial properties and have limited effects on changing the peel strength of the dressing.

[0004] To address the above problems, the present invention prepares a temperature-responsive hydrogel antibacterial dressing using a temperature-sensitive antibacterial material. On the one hand, it can enhance the antibacterial effect of the adhesive disk, and on the other hand, it can regulate the initial adhesion and peeling strength of the ostomy bag adhesive disk through temperature changes. This hydrogel dressing can better meet the actual clinical requirements for the peeling strength, corrosion resistance, and antibacterial properties of the ostomy bag adhesive disk, improve the comfort of using the ostomy bag, and reduce related complications. Summary of the Invention

[0005] One of the objectives of the present invention is to provide an antibacterial hydrogel dressing with temperature-regulable initial adhesion and peeling strength and its preparation method. This dressing can provide temperature sensitivity and antibacterial properties, regulate the peeling strength of the dressing on the patient's skin by controlling temperature changes, and simultaneously have good antibacterial ability. Another objective of the present invention is to provide an ostomy bag based on this antibacterial hydrogel dressing. This hydrogel dressing can provide beneficial temperature sensitivity, antibacterial, and corrosion-resistant properties for the ostomy bag adhesive disk.

[0006] The technical solution adopted by the present invention is as follows:

[0007] An antibacterial hydrogel dressing with temperature-regulable initial adhesion and peeling strength, wherein the hydrogel dressing is obtained by vacuum kneading a temperature-responsive antibacterial material, a thermoplastic elastomer, and hydrophilic polymer particles to obtain a hydrogel, and then stamping and forming. By mass, the raw material components are: 5-20 parts of the temperature-responsive antibacterial material, 20-50 parts of the thermoplastic elastomer, and 20-50 parts of the hydrophilic polymer particles; it has temperature responsiveness, and the initial adhesion and peeling strength of the dressing can change with temperature.

[0008] In the above technical solution, further, the temperature-responsive antibacterial material is obtained by mixing and curing monomer A, monomer B, hyperbranched polylysine, a photoinitiator, and a crosslinking agent in proportion, and both monomer A and monomer B are temperature-responsive monomers.

[0009] Further, the mass ratio of monomer A, monomer B, hyperbranched polylysine, photoinitiator, and crosslinking agent is: 7-3:2-6:0.1-1:0.02-0.1:0.02-0.1.

[0010] Its preparation method includes the following steps:

[0011] S1: Add monomer A, monomer B, hyperbranched polylysine, photoinitiator, and crosslinking agent to the solvent in sequence and stir until dissolved;

[0012] S2: Pour the above solution into a mold;

[0013] S3: Place the mold containing the solution in step S2 under an ultraviolet lamp and perform photocuring on the solution therein to obtain a transparent polymer;

[0014] S4: Place the polymer obtained in S3 in a vacuum oven for drying, usually for 6 - 24 h;

[0015] S5: Place the polymer obtained in S4 and the thermoplastic elastomer in an internal mixer, heat to melting, then add the hydrophilic polymer particles and mix at 100 - 200 °C, and cool;

[0016] S6: Coat the colloid layer obtained in S5 on a polyurethane film, cover it with glassine paper, place it in a flat vulcanizer and heat to melting, and press and form at 10 - 20 MPa to obtain a hydrocolloid dressing.

[0017] Preferably, the temperature-responsive monomer is one or more of polyethylene glycol diacrylate, polytetrahydrofuran diacrylate, and polycaprolactone diacrylate;

[0018] Preferably, the photoinitiator in step S1 can be any one of 2-hydroxy-4-(2-hydroxyethoxy)-2-methylpropiophenone and 2,3-pentanedione;

[0019] Preferably, the crosslinking agent in step S1 can be any one of methylene bisacrylamide, polyethylene glycol dimethacrylate, and polyethylene glycol (diol) diacrylate;

[0020] Preferably, the weight-average molecular weight of the hyperbranched polylysine used in S1 ranges from 3000 to 7000 Da, and the polydispersity index is between 1.01 and 1.2;

[0021] Preferably, the solvent in S1 is chloroform;

[0022] Preferably, the mixing time in S5 is 1 - 2 h;

[0023] Preferably, the heating temperature of the flat vulcanizer in S5 is 100 - 200 °C, and the pressure is 10 - 20 MPa.

[0024] In the present invention, the thermoplastic elastomer can be SIS, and the hydrophilic polymer particles are prepared by compounding sodium carboxymethyl cellulose (CMC) and crosslinked sodium carboxymethyl cellulose (X-CMC).

[0025] A stoma bag, characterized in that the adhesive plate of the stoma bag includes the antibacterial hydrocolloid dressing with temperature-controllable initial adhesion and peel strength as described in any one of the above.

[0026] The hydrocolloid dressing of the present invention has the following beneficial effects: By adjusting the temperature, the purpose of controlling its initial adhesion and peeling strength is achieved. The initial adhesion at 25 - 30°C is ≤15 N / cm, the initial adhesion at 37 - 40°C is ≥20 N / cm, the peeling strength at 25 - 30°C is ≤16 N / cm, and the peeling strength at 37 - 40°C is ≥25 N / cm. This temperature adjustment function can achieve a high-strength fit with the skin at the body surface temperature of the dressing. When replacing, the initial adhesion and peeling strength are reduced by cooling with cold compress, thereby achieving painless removal. The composite hydrophilic polymer used in the present invention has strong liquid absorption performance while having good strength. By adding hyperbranched polylysine, the risk of infection is reduced. An antibacterial hydrocolloid with temperature-controllable initial adhesion and peeling strength disclosed by the present invention can be applied to the preparation of ostomy pouch adhesive discs, dressings for fixing intravenous catheters, or dressings for treating catheter-related dermatitis. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] In order to make the objectives, technical solutions, and beneficial effects of the present invention clearer, the present invention provides the following drawings:

[0028] Figure 1 The figure shows the pattern of the ostomy pouch prepared in Example 1;

[0029] Figure 2 The DSC data of the commercially available ostomy pouch adhesive disc and the hydrocolloid dressing of Example 1. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0030] The technical solutions of the present invention will be described in detail below with reference to the drawings and embodiments, which are only for illustration and not for limiting the scope of the present invention.

[0031] Example 1:

[0032] A preparation method of an antibacterial hydrocolloid dressing with temperature-controllable initial adhesion and peeling strength is as follows:

[0033] Prepare a novel temperature-responsive antibacterial material: Polyethylene glycol diacrylate, polytetrahydrofuran diacrylate, polycaprolactone diacrylate, hyperbranched polylysine, 2-hydroxy-4-(2-hydroxyethoxy)-2-methylpropiophenone, and methylene bisacrylamide with a mass ratio of 3.5:1:4:0.5:0.45:0.55 are successively added to 500 mL of chloroform and mixed. After mixing evenly, it is poured into a polytetrafluoroethylene mold, and then placed in an ultraviolet curing box for curing. After curing, it is immediately placed in a vacuum drying oven and dried for 24 h to obtain a novel temperature-responsive antibacterial material.

[0034] Prepare the antibacterial hydrocolloid dressing:

[0035] Step a, weigh various materials according to the production list and place them in respective containers;

[0036] Step b: Add 40 parts of SIS hot-melt pressure-sensitive adhesive as the rubber substrate into a kneader preheated to 140°C, and stir for 1 - 2 min;

[0037] Step c: Add 20 parts of the novel temperature-responsive antibacterial material, 20 parts of cross-linked sodium carboxymethylcellulose (X-CMC), and 20 parts of sodium carboxymethylcellulose (CMC) into the kneader, close the lid and knead for 10 - 15 min until it forms a mass;

[0038] Step d: After kneading into a mass, start vacuum kneading for 120 min and then cool down to room temperature;

[0039] Step e: Coat the material obtained in the previous step on a polyurethane film, cover it with glassine paper, place it in a flat vulcanizer, heat it to melting, and press it into shape at 15 MPa to obtain a temperature-responsive hydrocolloid antibacterial dressing for ostomy bags ( Figure 2 ).

[0040] The adhesion ability of the temperature-responsive antibacterial hydrocolloid dressing for ostomy bags prepared in this example changes with temperature, and its temperature responsiveness is quantified by the differential scanning calorimetry (DSC) data of the material and the initial adhesion and peel strength at different temperatures ( Figure 2 , Table 1). It can be seen from Figure 2 that Example 1 has an endothermic peak at 30°C while the commercial product does not, indicating that the dressing in this example has temperature responsiveness. It can be seen from Table 1 that the initial adhesion of the dressing in this example is ≤15 N / cm at 25 - 30°C, ≥20 N / cm at 37 - 40°C, the peel strength is ≤16 N / cm at 25 - 30°C, and ≥25 N / cm at 37 - 40°C. It can be concluded that: compared with the commercial ostomy bag adhesive disc, the hydrocolloid dressing of Example 1 has excellent temperature responsiveness, which is conducive to enhancing adhesion in response to body temperature after fitting and tearing off after cooling.

[0041] Table 1. Initial adhesion and peel strength of commercial ostomy bag adhesive disc and hydrocolloid dressing of Example 1 at different temperatures

[0042]

[0043] The antibacterial performance of the hydrocolloid dressing of Example 1 is quantified by the 24-hour antibacterial rate against Escherichia coli and Staphylococcus aureus, and the results are shown in Table 2. By comparing the antibacterial data in Table 2, it can be seen that the hydrocolloid dressing of Example 1 has excellent antibacterial performance and the antibacterial rate reaches over 99%.

[0044] Table 2. Antibacterial data of commercial ostomy bag adhesive disc and hydrocolloid dressing of Example 1

[0045] Group Escherichia coli Staphylococcus aureus Example 1 99.93％ 99.91％ Commercially available ostomy bag 13.45％ 22.55％

[0046] The 24-hour liquid absorption amount and integrity in the corrosive liquid of the hydrocolloid dressing of Example 1 are shown in Tables 3 and 4. It can be seen that the liquid absorption performance of the hydrocolloid dressing of Example 1 of the present invention is basically the same as that of the commercially available ostomy pouch adhesive disk, but its corrosion resistance is better than that of the commercially available ostomy pouch adhesive disk.

[0047] Table 3. Liquid absorption amounts of the commercially available ostomy pouch adhesive disk and the hydrocolloid dressing of Example 1

[0048] Mass after liquid absorption (g) Example 1 Commercially available product <![CDATA[m0(0h)]]> 0.402 0.347 <![CDATA[m1(4h)]]> 0.804 0.804 <![CDATA[m2(8h)]]> 1.124 1.136 <![CDATA[m3(12h)]]> 1.232 1.248 <![CDATA[m4(24h)]]> 1.425 1.366 <![CDATA[Liquid absorption in 24h / (g / cm 2 )]]> 5115 4717

[0049] Table 4. Integrity of the commercially available ostomy pouch adhesive disk and the hydrocolloid dressing of Example 1 after 24 hours in the corrosive liquid

[0050]

[0051] It can be understood that the above specific description of the present invention is only for explaining the present invention and is not limited to the technical solutions described in the embodiments of the present invention. Those of ordinary skill in the art should understand that the present invention can still be modified or equivalently replaced to achieve the same technical effects; as long as the use requirements are met, they are all within the protection scope of the present invention.

Claims

1. An antibacterial hydrocolloid dressing with temperature - controllable initial adhesion and peel strength, characterized in that, The hydrocolloid dressing is obtained by vacuum kneading a temperature-responsive antibacterial material, a thermoplastic elastomer, and hydrophilic polymer particles to obtain a hydrocolloid, and then stamping and forming. By mass, the raw material components are: 5-20 parts of the temperature-responsive antibacterial material, 20-50 parts of the thermoplastic elastomer, and 20-50 parts of the hydrophilic polymer particles; It has temperature responsiveness, and the initial adhesion and peel strength of the dressing can change with temperature.

2. The antibacterial hydrocolloid dressing with temperature-adjustable initial adhesion and peel strength according to claim 1, wherein: The temperature-responsive antibacterial material is obtained by mixing and curing monomer A, monomer B, hyperbranched polylysine, a photoinitiator, and a crosslinking agent in proportion. Both monomer A and monomer B are temperature-responsive monomers.

3. The antibacterial hydrocolloid dressing with temperature-adjustable initial adhesion and peel strength according to claim 2, wherein: The mass ratio of monomer A, monomer B, hyperbranched polylysine, photoinitiator, and crosslinking agent is: 7-3:2-6:0.1-1:0.02-0.1:0.02-0.

1.

4. The antibacterial hydrocolloid dressing with temperature-adjustable initial adhesion and peel strength according to claim 2, characterized in that: The temperature-responsive monomer is one or more of polyethylene glycol diacrylate, polytetrahydrofuran diacrylate, and polycaprolactone diacrylate; the photoinitiator is any one of 2-hydroxy-4-(2-hydroxyethoxy)-2-methylpropiophenone and 2,3-pentanedione; the crosslinking agent is any one of methylene bisacrylamide, polyethylene glycol dimethacrylate, and polyethylene glycol (diol) diacrylate; the weight-average molecular weight range of the hyperbranched polylysine is 3000-7000 Da, and the polydispersity index is between 1.01 and 1.

2.

5. The antibacterial hydrocolloid dressing with temperature-controllable initial adhesion and peel strength according to claim 1, characterized in that: the hydrophilic polymer particles are composed of 1 part of sodium carboxymethylcellulose (CMC) and 1 part of crosslinked sodium carboxymethylcellulose (X-CMC), and the thermoplastic elastomer is a styrene-isoprene-styrene block copolymer.

6. The antibacterial hydrocolloid dressing with temperature-controllable initial adhesion and peel strength according to claim 1, characterized in that: the initial adhesion and peel strength of the dressing can change with temperature, specifically: the initial adhesion at 25-30 °C ≤ 15 N / cm, the initial adhesion at 37-40 °C ≥ 20 N / cm, the peel strength at 25-30 °C ≤ 16 N / cm, and the peel strength at 37-40 °C ≥ 25 N / cm.

7. The preparation method of the antibacterial hydrocolloid dressing with temperature-controllable initial adhesion and peeling strength according to any one of claims 2-6, characterized in that: It includes the following steps: S1: Add monomer A, monomer B, hyperbranched polylysine, photoinitiator, and crosslinking agent to a solvent in sequence and stir until dissolved; S2: Pour the above solution into a mold; S3: Place the mold containing the solution in step S2 under an ultraviolet lamp and carry out photocuring on the solution therein to obtain a polymer, namely the temperature-responsive antibacterial material; S4: Place the polymer obtained in step S3 in a vacuum oven for drying; S5: Place the polymer obtained in step S4 and the thermoplastic elastomer in a kneader, heat to melt, then add hydrophilic polymer particles and knead at 100-200 °C, and then cool; S6: Coat the colloidal layer obtained in step S5 on a polyurethane film, cover it with glassine paper, place it in a flat vulcanizer and heat to melt, and stamp and form at 10-20 MPa to obtain the antibacterial hydrocolloid dressing with temperature-controllable initial adhesion and peel strength.

8. Use of the antibacterial hydrocolloid dressing with temperature-adjustable initial adhesion and peeling strength according to any one of claims 1-6, characterized in that: For the preparation of ostomy pouch adhesive discs, dressings for fixing intravenous catheters, or dressings for preventing catheter-related dermatitis during treatment.

9. A stoma bag, characterized in that, The adhesive disc of the ostomy pouch includes the antibacterial hydrocolloid dressing with temperature-controllable initial adhesion and peel strength as described in any one of claims 1-6.

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