A hydrocolloid silica gel net

Abstract

The application relates to the technical field of medical materials, in particular to a hydrocolloid silica gel net and a preparation method thereof. The hydrocolloid silica gel net comprises a base material and a hydrophilic colloid, the base material is a silica gel net, and the hydrophilic colloid is stably dispersed in the silica gel net. The silica gel net and the hydrophilic colloid are included, the silica gel net is a net-shaped base material covered with silica gel on the surface, and the hydrophilic colloid is stably dispersed in the silica gel net. The silica gel net prepared by the application can embed the hydrocolloid component into the silica gel net, the hydrocolloid component cannot be sucked away by negative pressure, the prepared hydrocolloid silica gel net can prevent adhesion, has hydrophilicity, and can promote wound healing.

Description

Technical Field

[0001] This invention belongs to the field of medical materials technology, specifically relating to a hydrocolloid silica mesh and its preparation method. Background Technology

[0002] Negative pressure drainage can be used to remove blood accumulation from chronic and acute wounds. Clinically, negative pressure drainage uses polyurethane foam dressings applied to the wound. Polyurethane has large pores, and when negative pressure is applied to the wound using polyurethane as a dressing, granulation tissue can easily grow into the pores. Removing the dressing can damage the skin that is adhered to the pores.

[0003] Currently, in negative pressure wound therapy, hydrocolloid gauze combined with polyurethane foam is commonly used. This prevents wound adhesion without affecting the use of polyurethane, and the hydrocolloid gauze does not clog the mesh, thus ensuring the transmission of negative pressure. However, in a negative pressure environment, the hydrocolloid components coated on the gauze can be carried away by exudate, exposing the fiber mesh. The exposed fiber mesh adheres to the skin, hindering wound healing. Furthermore, the preparation method of hydrocolloid gauze is complex, requiring specialized equipment for coating the fiber mesh. After coating, the hydrocolloid gauze needs to encapsulate the hydrocolloid components, which can clog the mesh pores, resulting in a low yield rate for hydrocolloid gauze production.

[0004] Patent CN206138280U discloses a medical silicone isolation mesh dressing, which has a good anti-adhesion effect. However, the silicone mesh dressing is hydrophobic, which will dry the wound and is not conducive to wound healing. The mesh silicone mold is not easy to adhere to hydrocolloid materials due to its hydrophobicity.

[0005] Therefore, there is an urgent need to develop a product that does not lose its anti-adhesion effect under negative pressure conditions, providing patients with a more effective treatment option. Summary of the Invention

[0006] Therefore, it is necessary to provide a mesh silicone dressing that can prevent the loss of elastomers and other substances under negative pressure, and the product has an adhesive effect.

[0007] This invention provides a hydrocolloid silicone mesh, comprising a silicone mesh and a hydrophilic colloid, wherein the silicone mesh is a mesh substrate with a surface covered with silicone, and the hydrophilic colloid is stably dispersed in the silicone mesh.

[0008] Preferably, the particle size of the hydrophilic colloid is less than 30 μm.

[0009] Preferably, the hydrophilic colloid is a water-soluble polymer material.

[0010] Preferably, the water-soluble polymer material is selected from one or more of cellulose, pectin, seaweed, and starch.

[0011] Preferably, the water-soluble polymer material is cellulose.

[0012] Preferably, the cellulose is carboxymethyl cellulose.

[0013] This invention also provides a method for preparing a hydrocolloid silica mesh, comprising the following steps:

[0014] (1) Preparation of silicone mixture: Mix 180-250 parts by weight of silicone prepolymer with 10 parts by weight of curing agent;

[0015] (2) Add hydrophilic colloidal particles to the silica gel mixture and disperse using microwave;

[0016] (3) Coat 200 parts by weight of the silicone mixture prepared in step (2) onto the surface of 100-200 parts by weight of the substrate, and vulcanize at high temperature to obtain a hydrocolloid silicone mesh.

[0017] Preferably, the mass ratio of tetramethyltetravinylcyclotetrasiloxane to octamethylcyclotetrasiloxane in the prepolymer is 2:1, and the mass ratio of fumed silica, ditert-butyl peroxide, and diphenylsilanediol in the curing agent is 45:1:3.

[0018] Preferably, in step (2), the mass ratio of silica gel mixture to sodium carboxymethyl cellulose is (100-300): (35-57).

[0019] Preferably, step (2) may also include a suspending agent, wherein the suspending agent is α-tung oil acid.

[0020] Preferably, the mass ratio of silica gel mixture, sodium carboxymethyl cellulose, and α-tung oil acid is (100-300):(35-57):(0.5-2).

[0021] Preferably, the vulcanization temperature in step (3) is 120-140℃.

[0022] Preferably, the base fabric in step (3) is selected from polyester mesh, glass fiber cloth, natural fiber mesh or synthetic fiber mesh.

[0023] Compared with the prior art, the beneficial effects of the hydrocolloid silica mesh provided by the present invention are as follows:

[0024] (1) The hydrocolloid silicone mesh provided by the present invention contains hydrophilic colloids, which are particles of water-soluble polymers. The silicone mesh prepared by the present invention can embed the hydrocolloid components into the silicone mesh. The hydrocolloid components will not be absorbed by negative pressure. The prepared hydrocolloid silicone mesh can prevent adhesion and has hydrophilicity, which can promote wound healing.

[0025] (2) The hydrocolloid silicone mesh provided by the present invention has the ability to absorb liquid, providing a moist healing environment for the wound, without irritating the skin, without sticking to the wound, and without pain when changing dressings. Detailed Implementation

[0026] The present invention will be further described below through specific embodiments, but this is not a limitation of the present invention. Those skilled in the art can make various modifications or improvements based on the basic idea of ​​the present invention, but as long as they do not depart from the basic idea of ​​the present invention, they are all within the protection scope of the present invention.

[0027] The raw materials used in the specific embodiments of this invention are all commercially available.

[0028] This invention utilizes a reaction between a prepolymer and a curing agent to generate silicone on the surface of a polyester fiber substrate, thereby forming a silicone mesh. The prepolymer can be tetramethyltetravinylcyclotetrasiloxane, which is added to the curing solution octamethylcyclotetrasiloxane in a specific ratio for copolymerization. The mass ratio of tetramethyltetravinylcyclotetrasiloxane to octamethylcyclotetrasiloxane is 2:1. The mass ratio of fumed silica, ditert-butyl peroxide, and diphenylsilanediol in the curing agent is 45:1:3.

[0029] Example 1: A hydrocolloid silica mesh

[0030] This invention provides a hydrocolloid silicone mesh, the specific solution of which is as follows:

[0031] (1) Preparation of silicone mixture: Mix 180 parts by weight of silicone prepolymer with 10 parts by weight of curing agent;

[0032] (2) Add sodium carboxymethyl cellulose particles with a particle size of less than 30 μm to the silica gel mixture. The mass ratio of silica gel mixture to sodium carboxymethyl cellulose is 100:35. Disperse the mixture using microwave.

[0033] (3) Coat 200 parts by weight of the silicone mixture prepared in step (2) onto the surface of 100 parts by weight of the polyester fiber substrate, and place the substrate in a vulcanizing oven at 120°C for 30 minutes.

[0034] Example 2: A hydrocolloid silicone mesh

[0035] This invention provides a hydrocolloid silicone mesh, the specific solution of which is as follows:

[0036] (1) Preparation of silicone mixture: 250 parts by weight of silicone prepolymer and 10 parts by weight of curing agent are mixed;

[0037] (2) Add sodium carboxymethyl cellulose particles with a particle size of less than 30 μm to the silica gel mixture. The mass ratio of silica gel mixture to sodium carboxymethyl cellulose is 300:57. Disperse the mixture using microwave.

[0038] (3) Coat 100 parts by weight of the silicone mixture prepared in step (2) onto the surface of 200 parts by weight of the polyester fiber substrate, and place the substrate in a vulcanizing oven at 140°C for 60 min.

[0039] Example 3: A hydrocolloid silicone mesh

[0040] This invention provides a hydrocolloid silicone mesh, the specific solution of which is as follows:

[0041] (1) Preparation of silicone mixture: 210 parts by weight of silicone prepolymer and 10 parts by weight of curing agent are mixed;

[0042] (2) Add sodium carboxymethyl cellulose particles with a particle size of less than 30 μm to the silica gel mixture. The mass ratio of silica gel mixture to sodium carboxymethyl cellulose is 200:41.

[0043] (3) Coat 100 parts by weight of the silicone mixture prepared in step (2) onto the surface of 150 parts by weight of the polyester fiber substrate, and place the substrate in a vulcanizing oven at 130°C for 40 min.

[0044] Example 4: A hydrocolloid silicone mesh

[0045] This invention provides a hydrocolloid silicone mesh, the specific solution of which is as follows:

[0046] (1) Preparation of silicone mixture: 210 parts by weight of silicone prepolymer and 10 parts by weight of curing agent are mixed;

[0047] (2) Add sodium carboxymethyl cellulose particles with a particle size of less than 30 μm and α-tung oil acid to the silica gel mixture. The mass ratio of silica gel mixture, sodium carboxymethyl cellulose and α-tung oil acid is 200:41:0.5. Disperse by microwave.

[0048] (3) Coat 100 parts by weight of silicone mixture onto the surface of 150 parts by weight of polyester fiber substrate, and place the substrate in a vulcanizing oven at 130°C for 40 minutes.

[0049] Example 5: This invention provides a hydrocolloid silicone mesh, the specific solution of which is as follows:

[0050] (1) Preparation of silicone mixture: 210 parts by weight of silicone prepolymer and 10 parts by weight of curing agent are mixed;

[0051] (2) Add sodium carboxymethyl cellulose particles with a particle size of less than 30 μm and α-tung oil acid to the silica gel mixture. The mass ratio of silica gel mixture, sodium carboxymethyl cellulose, and α-tung oil acid is 200:41:1. Disperse using microwave.

[0052] (3) Coat 100 parts by weight of silicone mixture onto the surface of 150 parts by weight of polyester fiber substrate, and place the substrate in a vulcanizing oven at 130°C for 40 minutes.

[0053] Example 6: This invention provides a hydrocolloid silicone mesh, the specific solution of which is as follows:

[0054] (1) Preparation of silicone mixture: 210 parts by weight of silicone prepolymer and 10 parts by weight of curing agent are mixed;

[0055] (2) Add sodium carboxymethyl cellulose particles with a particle size of less than 30 μm and α-tung oil acid to the silica gel mixture. The mass ratio of silica gel mixture, sodium carboxymethyl cellulose and α-tung oil acid is 200:41:1. Disperse by microwave.

[0056] (3) Coat 100 parts by weight of silicone mixture onto the surface of 150 parts by weight of glass fiber cloth substrate, and place the substrate in a vulcanizing oven at 130°C for 40 minutes.

[0057] Comparative Example 1: Commercially available hydrocolloid oil-based gauze, Coloplast Corporation, sulfadiazine silver hydrocolloid oil-based gauze dressing, National Medical Device Registration Certificate No. 20163142947

[0058] Comparative Example 2: This invention provides a hydrocolloid silicone mesh, the specific solution of which is as follows:

[0059] (1) Preparation of silicone mixture: 210 parts by weight of silicone prepolymer and 10 parts by weight of curing agent are mixed;

[0060] (2) Add sodium carboxymethyl cellulose particles with a particle size of less than 30 μm and β-tung oil acid to the silica gel mixture. The mass ratio of silica gel mixture, sodium carboxymethyl cellulose, and β-tung oil acid is 200:41:1.

[0061] (3) Coat 100 parts by weight of silicone mixture onto the surface of 150 parts by weight of polyester fiber substrate, and place the substrate in a vulcanizing oven at 130°C for 40 minutes.

[0062] Comparative Example 3: This invention provides a hydrocolloid silicone mesh, the specific solution of which is as follows:

[0063] (1) Preparation of silicone mixture: 210 parts by weight of silicone prepolymer and 10 parts by weight of curing agent are mixed;

[0064] (2) Add sodium carboxymethyl cellulose particles with a particle size of less than 30 μm and castor oil to the silica gel mixture. The mass ratio of silica gel mixture, sodium carboxymethyl cellulose and castor oil is 200:41:1. Disperse by microwave.

[0065] (3) Coat 100 parts by weight of silicone mixture onto the surface of 150 parts by weight of polyester fiber substrate, and place the substrate in a vulcanizing oven at 130°C for 40 minutes.

[0066] Comparative Example 4: This invention provides a hydrocolloid silicone mesh, the specific solution of which is as follows:

[0067] (1) Preparation of silicone mixture: 210 parts by weight of silicone prepolymer and 10 parts by weight of curing agent are mixed;

[0068] (2) Add sodium carboxymethyl cellulose particles with a particle size of less than 30 μm and α-tung oil acid to the silica gel mixture. The mass ratio of silica gel mixture, sodium carboxymethyl cellulose and α-tung oil acid is 200:41:0.3. Disperse by microwave.

[0069] (3) Coat 100 parts by weight of silicone mixture onto the surface of 150 parts by weight of polyester fiber substrate, and place the substrate in a vulcanizing oven at 130°C for 4 minutes.

[0070] Comparative Example 5: This invention provides a hydrocolloid silicone mesh, the specific solution of which is as follows:

[0071] (1) Preparation of silicone mixture: 210 parts by weight of silicone prepolymer and 10 parts by weight of curing agent are mixed;

[0072] (2) Add sodium carboxymethyl cellulose particles with a particle size of less than 30 μm and α-tung oil acid to the silica gel mixture. The mass ratio of silica gel mixture, sodium carboxymethyl cellulose and α-tung oil acid is 200:41:3. Disperse by microwave.

[0073] (3) Coat 100 parts by weight of silicone mixture onto the surface of 150 parts by weight of polyester fiber substrate, and place the substrate in a vulcanizing oven at 130°C for 4 minutes.

[0074] Animal experiments:

[0075] Test Example 1: Anti-adhesion Test

[0076] 1. Experimental materials: hydrocolloidal silica mesh prepared in Examples 1-6 and Comparative Examples 2-5, and hydrocolloidal oil yarn in Comparative Example 1;

[0077] 2. Experimental subjects: 240 SD rats, weighing 200±10g, half male and half female;

[0078] 3. Experimental Methods: SD rats were randomly divided into 12 groups of 20 rats each, with half male and half female. The control group used physiological saline. Examples 1-6 and Comparative Examples 2-5 used the prepared hydrocolloid silicone mesh, while Comparative Example 1 used hydrocolloid gauze. Anesthesia was administered via intraperitoneal injection of 2% sodium pentobarbital solution (30 mg / kg). Hair was removed from the back using 8% sodium sulfide, and the area was disinfected with 70% ethanol cotton balls. Two circular, second-degree II wounds, 2.5 cm in diameter, were applied along the spine using an adjustable electrocautery device, with a 2 cm gap between the wounds and a pressure of 1 kg. Examples 1-6 and Comparative Examples 2-5 were covered with hydrocolloid silicone mesh, while Comparative Example 1 was covered with hydrocolloid gauze. On the 7th and 14th day after surgery, 10 animals from each group were euthanized under chloral hydrate anesthesia. Adhesion was observed and graded. No adhesion was grade 0, with a score of 0. One adhesion between the product and the wound was grade I, with a score of 1. Two adhesions between the product and the wound were grade II, with a score of 2. More than two adhesions but the product was not directly adhered to the wound, with a score of 3. The product was directly adhered to the wound, regardless of the number of adhesions, with a score of 4.

[0079] Table 1 Results of the anti-adhesion test

[0080] As shown in Table 1, on the 7th and 14th day post-surgery, the adhesion level of Examples 1-6 was 0-I. Comparative Example 1, using commercially available hydrocolloid gauze, showed an adhesion level of I-II. Comparative Examples 2 and 3, using β-tung oil acid and castor oil instead of α-tung oil acid, also showed adhesion levels of I-II. The α-tung oil acid in Comparative Examples 4 and 5 was outside the range of Examples 1-6, resulting in a lower adhesion level than Examples 1-6. The adhesion level of the blank group was mainly in the III-IV range. Therefore, the hydrocolloid silicone mesh prepared in this invention has a very good anti-adhesion effect.

[0081] Test Example 2: Anti-adhesion test after applying negative pressure

[0082] 1. Experimental materials: hydrocolloidal silica mesh prepared in Examples 1-6 and Comparative Examples 2-5, and hydrocolloidal oil yarn in Comparative Example 1;

[0083] 2. Experimental subjects: 240 SD rats, weighing 200±10g, half male and half female;

[0084] 3. Experimental Methods: SD rats were randomly divided into 12 groups of 20 rats each, with half male and half female. The control group used physiological saline. Examples 1-6 and Comparative Examples 2-5 used the prepared hydrocolloid silicone mesh, while Comparative Example 1 used hydrocolloid gauze. Anesthesia was administered via intraperitoneal injection of 2% sodium pentobarbital solution (30 mg / kg). Hair was removed from the back using 8% sodium sulfide, and the area was disinfected with 70% ethanol cotton balls. Two circular, deep second-degree wounds (2.5 cm in diameter) were applied along the spine using an adjustable electrocautery device, with a 2 cm gap between the wounds and a 2.5 cm diameter, at a pressure of 1 kg. In Example 3, the wound was covered with a hydrocolloid silicone mesh, and a polyurethane foam dressing was placed on top of the mesh. A negative pressure system was continuously used to aspirate exudate. In Comparative Example 1, the wound was covered with hydrocolloid gauze, and a polyurethane foam dressing was placed on top of the gauze. A negative pressure system was continuously used to aspirate exudate. On the 7th and 14th day after surgery, 10 animals from each group were euthanized under chloral hydrate anesthesia. Adhesion was observed and graded. No adhesion was grade 0, with a score of 0. One adhesion between the product and the wound was grade I, with a score of 1. Two adhesions between the product and the wound were grade II, with a score of 2. More than two adhesions but the product was not directly adhered to the wound, with a score of 3. The product was directly adhered to the wound, regardless of the number of adhesions, with a score of 4.

[0085] Table 2 Results of Anti-adhesion Test

[0086] As shown in Table 2, on the 7th and 14th days post-surgery, the adhesion levels of Examples 1-6 were 0-I. Comparative Example 1, using commercially available hydrocolloid gauze, showed adhesion levels of II-III. Comparative Example 1, using the method of Experiment 1, showed adhesion levels of I-II. However, due to the negative pressure suction of petrolatum, liquid paraffin, and sodium carboxymethyl cellulose adhering to the hydrocolloid gauze, the anti-adhesion effect was significantly reduced. The adhesion level of the blank group was mainly at III-IV. Therefore, it can be concluded that the hydrocolloid silicone mesh prepared in this invention has a better anti-adhesion effect than hydrocolloid gauze under negative pressure conditions.

[0087] Experiment Example 3: Wound Healing Experiment

[0088] The results of observing the wound healing effect in Experiment Example 1 are shown in the table below:

[0089] Table 3 Performance Test Results

[0090] Group Wound healing time / day wound healing effect Example 1 6-8 No scarring Example 2 5-7 No scarring Example 3 7-9 No scarring Example 4 6-9 No scarring Example 5 6-8 No scarring Example 6 7-9 No scarring Comparative Example 1 12-14 Mild scarring occurred Comparative Example 2 9-12 Mild scarring occurred Comparative Example 3 10-13 Mild scarring occurred Comparative Example 4 11-13 Mild scarring occurred Comparative Example 5 12-14 Mild scarring occurred

[0091] As shown in Table 3, the hydrocolloid silicone mesh prepared in this application can effectively inhibit scar formation and shorten healing time.

[0092] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A hydrocolloid silicone mesh, characterized in that, The device includes a silicone mesh and a hydrophilic colloid, wherein the hydrophilic colloid is sodium carboxymethyl cellulose with a particle size of less than 30 μm, the silicone mesh is a mesh substrate with a surface covered with silicone, the hydrophilic colloid is stably dispersed in the silicone mesh, and the mesh substrate is selected from polyester mesh, glass fiber cloth, natural fiber mesh or synthetic fiber mesh. The silicone mesh is made by coating 200 parts by weight of silicone mixture onto the surface of 100-200 parts by weight of mesh substrate, followed by surface vulcanization. The silicone mixture is composed of 180-250 parts by weight of silicone prepolymer and 10 parts by weight of curing agent; The prepolymer contains tetramethyltetravinylcyclotetrasiloxane in a mass ratio of 2:1 to octamethylcyclotetrasiloxane, and the curing agent contains fumed silica, ditert-butyl peroxide, and diphenylsilanediol in a mass ratio of 45:1:

3.

2. A method for preparing a hydrocolloid silica mesh as described in claim 1, characterized in that, Includes the following steps: (1) Preparation of silicone mixture: Mix 180-250 parts by weight of silicone prepolymer with 10 parts by weight of curing agent; the mass ratio of tetramethyltetravinylcyclotetrasiloxane to octamethylcyclotetrasiloxane in the prepolymer is 2:1, and the mass ratio of fumed silica, ditert-butyl peroxide and diphenylsilanediol in the curing agent is 45:1:

3. (2) Add hydrophilic colloidal particles to the silica gel mixture and disperse them using microwave; (3) Coat 200 parts by weight of the silicone mixture prepared in step (2) onto the surface of 100-200 parts by weight of the mesh substrate, vulcanize the surface, and cover the mesh substrate with silicone to obtain a hydrocolloid silicone mesh.

3. The method for preparing the hydrocolloid silica mesh as described in claim 2, characterized in that, The hydrophilic colloidal particles are sodium carboxymethyl cellulose. In step (2), the mass ratio of silica gel mixture to sodium carboxymethyl cellulose is (100-300): (35-57).

4. The method for preparing the hydrocolloid silica mesh as described in claim 3, characterized in that, Step (2) may also include the addition of a suspending agent, wherein the suspending agent is α-tung oil acid.

5. The method for preparing the hydrocolloid silica mesh as described in claim 4, characterized in that, The mass ratio of silica gel mixture, sodium carboxymethyl cellulose, and α-tung oil acid is (100-300):(35-57):(0.5-2).

6. The method for preparing the hydrocolloid silica mesh as described in claim 2, characterized in that, In step (3), the vulcanization temperature is 120-140℃.