Preparation method of iodine-containing operation film and iodine-containing operation film

Abstract

The invention relates to the technical field of medical surgical films, in particular to a preparation method of an iodine-containing surgical film and the iodine-containing surgical film. S2, silicone oil, n-butyl acetate and xylene are mixed and stirred, and a silicone oil mixed solution is obtained; s3, uniformly coating a release base material with the silicone oil mixed liquid, putting the release base material into a drying oven, and drying and curing at the drying temperature of 80-120 DEG C for 5-20 minutes to obtain a release layer; and S4, uniformly coating one side of the base layer with the modified adhesive to form an adhesive layer, covering the other side of the adhesive layer with a release layer, and carrying out drying and curing treatment to obtain the iodine-containing operation film. The modified adhesive provided by the invention has better optical transmissivity so as to facilitate observation in an operation process, and meanwhile, the iodine elementary substance can be more effectively utilized, so that the antibacterial property is improved, and the applicability of the operation film is improved.

Description

Technical Field

[0001] The invention relates to the technical field of medical surgical films, in particular to a preparation method of an iodine-containing surgical film and the iodine-containing surgical film. Background Art

[0002] In the field of medical devices, especially in surgical operations, controlling hospital infection is an issue that cannot be ignored. At present, the infection of surgical incisions is mainly prevented. In addition to strengthening the aseptic operation of surgical operations, the preventive use of antibiotics has been widely recognized. However, there are many adverse reactions to systemic antibiotics, and the local blood drug concentration of surgical incisions is low, making it difficult to effectively kill bacteria attached to the surgical incisions. In order to solve this problem, iodine-containing surgical films have appeared on the market. This film is made into a new type of antibacterial film of various specifications by attaching iodine ions to medical films. This film can protect the skin near the surgical site, form a sterile surgical area, and have a continuous antibacterial effect on the incision site. After use, the types and number of bacteria in the surgical incision are significantly reduced, and the incidence of surgical site infection is reduced.

[0003] Nevertheless, there are still some limitations in the surgical films in the prior art. For example, the barrier properties of the existing surgical films are strong and the optical transmittance is poor, which makes it difficult to see the skin under the surgical film, affecting the accuracy and safety of the operation. In addition, the iodine element is difficult to volatilize during operation, resulting in weak antibacterial properties. When using the surgical film, the iodine element has no specific medium to drive the work and volatilization, resulting in a large amount of iodine element being wasted, and the antibacterial work is not completed, resulting in poor applicability of the surgical film. Therefore, it is necessary to develop a new iodine-containing surgical film and a preparation method thereof to solve these problems in the prior art. Summary of the invention

[0004] In order to overcome the deficiencies of the prior art, the object of the present invention is to provide a method for preparing an iodine-containing surgical film and an iodine-containing surgical film.

[0005] To achieve the above object, the present invention provides the following technical solutions: A method for preparing an iodine-containing surgical film comprises the following steps: S1. Preparation of modified adhesive: S101. The mass ratio of 4-9 parts of an emulsion type acrylic adhesive and 15-20 parts of an acetone solution was mixed and stirred to obtain an adhesive solution; S102. 5-9 parts of modified nano-silica are slowly added to the binder solution according to the mass ratio, while stirring, so that the modified nano-silica is evenly dispersed in the binder solution to obtain a preliminary modified binder; S103. In the preliminary modified adhesive, 0.8-2 parts of iodine solution and 1-2 parts of polyacrylic acid were added by mass ratio and mechanically stirred at a stirring speed of 400-500r / min for 1-3h to obtain a modified adhesive; S2. The silicone oil, n-butyl acetate and xylene were mixed and stirred to obtain a silicone oil mixture; S3. The silicone oil mixture is evenly coated on the release substrate and placed in a drying oven for drying and curing at a drying temperature of 80-120°C for a drying time of 5-20min to obtain a release layer; S4. The modified adhesive is evenly coated on one side of the base layer to form an adhesive layer, and the other side of the adhesive layer is covered with a release layer. After drying and curing, an iodine-containing surgical film is obtained.

[0006] Preferably, in step S102, the modified nano-silica comprises the following preparation steps: S201. In a mixed solvent containing aqueous ammonia and anhydrous ethanol, isoamyl acetate is slowly added dropwise and stirred at 60-70°C for 15-20min to form a nano-silica sol; S202. 3-5 parts of methacryloxysilane are added dropwise to 15-20 parts of nano-silica sol, and magnetically stirred at a speed of 300-400r / min for 2-4h to obtain a preliminary modified nano-silica solution; S203. The modified nano-silica is separated from the initially modified nano-silica solution by high-speed centrifugation, and the modified nano-silica is washed with anhydrous ethanol and water in sequence, and then vacuum dried and ground to obtain modified nano-silica.

[0007] Preferably, in step S201, the mass ratio of aqueous ammonia, anhydrous ethanol and isoamyl acetate is 3-7:3-9:2-5.

[0008] Preferably, in step S203, the centrifugal speed is 7500-8000 rpm and the time is 10-15 min.

[0009] Preferably, in step S2, the mass ratio of the silicone oil, n-butyl acetate and xylene is 1:3-5:5-15.

[0010] Preferably, the coating thickness in step S3 is 0.5-2 μm.

[0011] Preferably, the thickness of the base layer is 20-50 μm, and the thickness of the release layer is 70-110 μm.

[0012] Preferably, in step S3, the release layer substrate is one of polyethylene, polypropylene, polyurethane, and polyethylene terephthalate.

[0013] Preferably, in step S4, the base layer is one of a polyethylene film, a polypropylene film, a polyvinyl chloride film, a polycarbonate film, and a polyester film.

[0014] An iodine-containing surgical film prepared according to the method.

[0015] Compared with the prior art, the present invention has the following beneficial effects: 1. The modified adhesive described in the present invention has better optical transmittance, which is convenient for observation during surgery, and can more effectively utilize iodine and improve the applicability of surgical films.

[0016] 2. The hydrophobicity of silica is improved by modifying it, making the surgical film more adherent to wet tissues and preventing contamination by blood, body fluids and other liquids during surgery. It also fills the tiny pores in the film, making the surface of the film smoother and flatter, reducing the scattering of light, and thus improving the transparency of the film.

[0017] 3. The present invention combines nanotechnology and biomedical materials, embodying innovations in the fields of material science and medical devices, so that the surgical film of the present invention has potential advantages in clinical applications and can provide safer and more effective surgical environment protection. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 This is a diagram of the steps for preparing the iodine-containing surgical film of the present invention. DETAILED DESCRIPTION

[0019] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0020] See also Figure 1 , the present invention provides a technical solution: Example 1

[0021] A method for preparing an iodine-containing surgical film: S1. Preparation of modified adhesive: S101. The mass ratio of 4 parts of an emulsion type acrylic adhesive and 15 parts of an acetone solution was mixed and stirred to obtain an adhesive solution; S102. Slowly adding 5 parts of modified nano-silica to the binder solution according to the mass ratio, stirring at the same time, so that the modified nano-silica is evenly dispersed in the binder solution to obtain a preliminary modified binder; S103. Add 0.8 parts of iodine solution and 1 part of polyacrylic acid in a mass ratio to the preliminarily modified adhesive and stir mechanically at a stirring speed of 400 r / min for 1 hour to obtain a modified adhesive.

[0022] S2. The silicone oil, n-butyl acetate, and xylene were mixed and stirred in a mass ratio of 1:3:5 to obtain a silicone oil mixture; S3. The silicone oil mixture is evenly coated on the release substrate, the coating thickness is 0.5 μm, and placed in a drying oven for drying and curing, the drying temperature is 80 ° C, the drying time is 5 min, and a release layer is obtained; S4. The modified adhesive is evenly coated on one side of the base layer to form an adhesive layer, and the other side of the adhesive layer is covered with a release layer. After drying and curing, an iodine-containing surgical film is obtained.

[0023] The modified nano silicon dioxide comprises the following preparation steps: S201. slowly drop isoamyl acetate into a mixed solvent containing aqueous ammonia and anhydrous ethanol, and stir at 60°C for 15 minutes to form a nano-silica sol, wherein the mass ratio of aqueous ammonia: anhydrous ethanol: isoamyl acetate is 3:3:2; S202. 3 parts of methacryloxysilane were added dropwise to 15 parts of nano-silica sol according to the mass ratio, and magnetic stirring was performed at 300 r / min for 2 h to obtain a preliminary modified nano-silica solution; S203. The initially modified nano-silica solution is centrifuged at a high speed of 7500 rpm for 15 min to separate the modified nano-silica, which is washed with anhydrous ethanol and water in turn, and then vacuum dried and ground to obtain modified nano-silica. Example 2

[0024] A method for preparing an iodine-containing surgical film: S1. Preparation of modified adhesive: S101. The mass ratio of 9 parts of an emulsion type acrylic adhesive and 20 parts of an acetone solution was mixed and stirred to obtain an adhesive solution; S102. Slowly adding 9 parts of modified nano-silica to the binder solution according to the mass ratio, stirring at the same time, so that the modified nano-silica is evenly dispersed in the binder solution to obtain a preliminary modified binder; S103. Add 2 parts of iodine solution and 2 parts of polyacrylic acid to the preliminarily modified adhesive in a mass ratio and stir mechanically at a stirring speed of 500 r / min for 3 hours to obtain a modified adhesive.

[0025] S2. The silicone oil, n-butyl acetate and xylene were mixed and stirred in a mass ratio of 1:5:15 to obtain a silicone oil mixture; S3. The silicone oil mixture is evenly coated on the release substrate, the coating thickness is 2 μm, and placed in a drying oven for drying and curing, the drying temperature is 120 ° C, the drying time is 20 min, and a release layer is obtained; S4. The modified adhesive is evenly coated on one side of the base layer to form an adhesive layer, and the other side of the adhesive layer is covered with a release layer. After drying and curing, an iodine-containing surgical film is obtained.

[0026] The modified nano silicon dioxide comprises the following preparation steps: S201. slowly drop isoamyl acetate into a mixed solvent containing aqueous ammonia and anhydrous ethanol, and stir at 70°C for 20 minutes to form a nano-silica sol, wherein the mass ratio of aqueous ammonia: anhydrous ethanol: isoamyl acetate is 7:9:5; S202. 5 parts of methacryloxysilane were added dropwise to 20 parts of nano-silica sol according to the mass ratio, and magnetic stirring was performed at 400 r / min for 4 h to obtain a preliminary modified nano-silica solution; S203. The initially modified nano-silica solution is centrifuged at a high speed of 8000 rpm for 20 min to separate the modified nano-silica, which is washed with anhydrous ethanol and water in turn, and then vacuum dried and ground to obtain modified nano-silica. Example 3

[0027] A method for preparing an iodine-containing surgical film: S1. Preparation of modified adhesive: S101. The mass ratio of 6 parts of an emulsion type acrylic adhesive and 17 parts of an acetone solution were mixed and stirred to obtain an adhesive solution; S102. Slowly adding 6 parts of modified nano-silica to the binder solution according to the mass ratio, stirring at the same time, so that the modified nano-silica is evenly dispersed in the binder solution to obtain a preliminary modified binder; S103. Add 1 part of iodine solution and 1.5 parts of polyacrylic acid in a mass ratio to the preliminarily modified adhesive and stir mechanically at a stirring speed of 450 r / min for 2 h to obtain a modified adhesive.

[0028] S2. Mix and stir silicone oil, n-butyl acetate, and xylene in a mass ratio of 1:4:8 to obtain a silicone oil mixture; S3. The silicone oil mixture is evenly coated on the release substrate, the coating thickness is 1 μm, and placed in a drying oven for drying and curing, the drying temperature is 100 ° C, the drying time is 10 min, and a release layer is obtained; S4. The modified adhesive is evenly coated on one side of the base layer to form an adhesive layer, and the other side of the adhesive layer is covered with a release layer. After drying and curing, an iodine-containing surgical film is obtained.

[0029] The modified nano silicon dioxide comprises the following preparation steps: S201. slowly drop isoamyl acetate into a mixed solvent containing aqueous ammonia and anhydrous ethanol, and stir at 62°C for 17 minutes to form a nano-silica sol, wherein the mass ratio of aqueous ammonia: anhydrous ethanol: isoamyl acetate is 4:5:3; S202. 4 parts of methacryloxysilane were added dropwise to 17 parts of nano-silica sol according to the mass ratio, and magnetic stirring was performed at 350 r / min for 3 h to obtain a preliminary modified nano-silica solution; S203. The initially modified nano-silica solution is centrifuged at a high speed of 7550 rpm for 17 min to separate the modified nano-silica, which is washed with anhydrous ethanol and water in turn, and then vacuum dried and ground to obtain modified nano-silica. Example 4

[0030] A method for preparing an iodine-containing surgical film: S1. Preparation of modified adhesive: S101. 8 parts of an emulsion acrylic adhesive and 18 parts of an acetone solution were mixed and stirred in a mass ratio to obtain an adhesive solution; S102. 8 parts of modified nano-silica were slowly added to the binder solution according to the mass ratio, while stirring, so that the modified nano-silica was evenly dispersed in the binder solution to obtain a preliminary modified binder; S103. Add 1.5 parts of iodine solution and 2 parts of polyacrylic acid in a mass ratio to the preliminarily modified adhesive and stir mechanically at a stirring speed of 450 r / min for 2 hours to obtain a modified adhesive.

[0031] S2. The silicone oil, n-butyl acetate and xylene were mixed and stirred in a mass ratio of 1:4:13 to obtain a silicone oil mixture; S3. The silicone oil mixture is evenly coated on the release substrate, the coating thickness is 1.5 μm, and placed in a drying oven for drying and curing, the drying temperature is 110 ° C, the drying time is 15 min, and a release layer is obtained; S4. The modified adhesive is evenly coated on one side of the base layer to form an adhesive layer, and the other side of the adhesive layer is covered with a release layer. After drying and curing, an iodine-containing surgical film is obtained.

[0032] The modified nano silicon dioxide comprises the following preparation steps: S201. Slowly drop isoamyl acetate into a mixed solvent containing aqueous ammonia and anhydrous ethanol, and stir at 60-70° C. for 18 min to form a nano-silica sol, wherein the mass ratio of aqueous ammonia: anhydrous ethanol: isoamyl acetate is 6:8:3; S202. 4 parts of methacryloxysilane were added dropwise to 18 parts of nano-silica sol according to the mass ratio, and magnetic stirring was performed at 350 r / min for 3 h to obtain a preliminary modified nano-silica solution; S203. The initially modified nano-silica solution is centrifuged at a high speed of 7800 rpm for 18 min to separate the modified nano-silica, which is washed with anhydrous ethanol and water in turn, and then vacuum dried and ground to obtain modified nano-silica.

[0033] Comparative Example 1 A method for preparing an iodine-containing surgical film: S1. Preparation of modified adhesive: S101. The mass ratio of 4 parts of an emulsion type acrylic adhesive and 15 parts of an acetone solution was mixed and stirred to obtain an adhesive solution; S102. Slowly adding 5 parts of nano-silica to the binder solution by mass while stirring to uniformly disperse the nano-silica in the binder solution to obtain a preliminary modified binder; S103. Add 0.8 parts of iodine solution and 1 part of polyacrylic acid in a mass ratio to the preliminarily modified adhesive and stir mechanically at a stirring speed of 400 r / min for 1 hour to obtain a modified adhesive.

[0034] S2. The silicone oil, n-butyl acetate, and xylene were mixed and stirred in a mass ratio of 1:3:5 to obtain a silicone oil mixture; S3. The silicone oil mixture is evenly coated on the release substrate, the coating thickness is 0.5 μm, and placed in a drying oven for drying and curing, the drying temperature is 80 ° C, the drying time is 5 min, and a release layer is obtained; S4. The modified adhesive is evenly coated on one side of the base layer to form an adhesive layer, and the other side of the adhesive layer is covered with a release layer. After drying and curing, an iodine-containing surgical film is obtained.

[0035] Comparative Example 2 A method for preparing an iodine-containing surgical film: S1. Mix and stir silicone oil, n-butyl acetate and xylene in a mass ratio of 1:3:5 to obtain a silicone oil mixture; S2. The silicone oil mixture is evenly coated on the release substrate, the coating thickness is 0.5 μm, and placed in a drying oven for drying and curing at a drying temperature of 80°C and a drying time of 5 min to obtain a release layer; S3. The water-based polyurethane adhesive is evenly coated on one side of the base layer to form an adhesive layer, and the other side of the adhesive layer is covered with a release layer. After drying and curing, a surgical film is obtained.

[0036] Performance Testing: With reference to the YY0852-2011 standard, the examples 1-4 and the comparative examples 1-2 were tested for their stickiness, peeling strength and extensibility. The stickiness test was conducted by placing the obtained surgical film in a 36-38°C oven for a period of time, and the top of the surgical film attached to the stainless steel plate should not slide down by more than 2.5mm; the peeling strength was conducted by evaluating the force required to peel the surgical film from the stainless steel plate, and the average force required for every 1cm of width should be no less than 1.0N; the extensibility should be no more than 2N / cm. With reference to the YY0615.1 standard, the sterility requirements were tested by testing whether there were microorganisms surviving in the surgical film after sterilization; with reference to the national standard GB / T2410-2008, the light transmittance was tested, and the results are shown in Table 1 below: Table 1 Stickiness Peel strength Stretchability Transmittance Sterility requirements Example 1 1.2mm 4.3N 0.5N / cm 97.8% No viable microorganisms Example 2 1.2mm 4.5N 0.6N / cm 97.5% No viable microorganisms Example 3 1.3mm 4.3N 0.5N / cm 97.8% No viable microorganisms Example 4 1.3mm 4.4N 0.7N / cm 97.4% No viable microorganisms Comparative Example 1 2.3mm 1.5N 1.7N / cm 93.0% Microorganisms survive Comparative Example 2 2.4mm 1.3N 1.9N / cm 92.8% Microorganisms survive Comparative Example 1 omitted the modification of nano silicon dioxide compared to Example 1, and Comparative Example 2 changed the modified adhesive to an adhesive commonly used in the preparation of common surgical films compared to Example 1 for experiment. According to the obtained data, the various properties of Examples 1-4 all meet the requirements, ensuring the stability and reliability during the operation, and the various properties are better than Comparative Examples 1-2, showing that the modified adhesive described in the present invention has better optical transmittance, and can more effectively utilize iodine, improve antibacterial properties, and improve the applicability of surgical films. The hydrophobicity of silicon dioxide is improved by the modification of silicon dioxide, so that the adhesion of surgical films on wet tissues is stronger, and liquid contamination such as blood and body fluids during the operation is prevented, and the tiny pores in the film are filled, so that the film surface is smoother and flatter, and the scattering of light is reduced, thereby further improving the transparency of the film.

[0037] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A method for preparing an iodine-containing surgical film, characterized in that: The following steps are involved: S1. Preparation of modified adhesive: S101. The mass ratio of 4-9 parts of an emulsion type acrylic adhesive and 15-20 parts of an acetone solution was mixed and stirred to obtain an adhesive solution; S102. 5-9 parts of modified nano-silica are slowly added to the binder solution according to the mass ratio, while stirring, so that the modified nano-silica is evenly dispersed in the binder solution to obtain a preliminary modified binder; S103. In the preliminary modified adhesive, 0.8-2 parts of iodine solution and 1-2 parts of polyacrylic acid were added by mass ratio and mechanically stirred at a stirring speed of 400-500r / min for 1-3h to obtain a modified adhesive; S2. The silicone oil, n-butyl acetate and xylene were mixed and stirred to obtain a silicone oil mixture; S3. The silicone oil mixture is evenly coated on the release substrate and placed in a drying oven for drying and curing at a drying temperature of 80-120°C for a drying time of 5-20min to obtain a release layer; S4. The modified adhesive is evenly coated on one side of the base layer to form an adhesive layer, and the other side of the adhesive layer is covered with a release layer. After drying and curing, an iodine-containing surgical film is obtained.

2. The method for preparing an iodine-containing surgical film according to claim 1, characterized in that: In step S102, the modified nano-silica comprises the following preparation steps: S201. In a mixed solvent containing aqueous ammonia and anhydrous ethanol, isoamyl acetate is slowly added dropwise and stirred at 60-70°C for 15-20min to form a nano-silica sol; S202. 3-5 parts of methacryloxysilane are added dropwise to 15-20 parts of nano-silica sol, and magnetically stirred at a speed of 300-400r / min for 2-4h to obtain a preliminary modified nano-silica solution; S203. The modified nano-silica is separated from the initially modified nano-silica solution by high-speed centrifugation, and the modified nano-silica is washed with anhydrous ethanol and water in sequence, and then vacuum dried and ground to obtain modified nano-silica.

3. The method for preparing an iodine-containing surgical film according to claim 2, characterized in that: In step S201, the mass ratio of ammonia water, anhydrous ethanol and isoamyl acetate is 3-7:3-9:2-5.

4. The method for preparing an iodine-containing surgical film according to claim 2, characterized in that: In step S203, the centrifugal speed is 7500-8000 rpm and the time is 10-15 min.

5. The method for preparing an iodine-containing surgical film according to claim 1, characterized in that: In step S2, the mass ratio of the silicone oil, n-butyl acetate and xylene is 1:3-5:5-15.

6. The method for preparing an iodine-containing surgical film according to claim 1, characterized in that: The coating thickness in step S3 is 0.5-2 μm.

7. The method for preparing an iodine-containing surgical film according to claim 1, characterized in that: The thickness of the base layer is 20-50 μm, and the thickness of the release layer is 70-110 μm.

8. The method for preparing an iodine-containing surgical film according to claim 1, characterized in that: In step S3, the release layer substrate is one of polyethylene, polypropylene, polyurethane, and polyethylene terephthalate.

9. The method for preparing an iodine-containing surgical film according to claim 1, characterized in that: In step S4, the base layer is one of a polyethylene film, a polypropylene film, a polyvinyl chloride film, a polycarbonate film, and a polyester film.

10. An iodine-containing surgical film, characterized in that: The iodine-containing surgical film is prepared according to the method for preparing the iodine-containing surgical film according to any one of claims 1 to 9.

Images