A medical high-barrier packaging film and a preparation method thereof

Abstract

The application discloses a kind of medical high-barrier packaging film and preparation method, it is related to packaging film field.The application is when preparing medical high-barrier packaging film, mica sheet is grafted [3-(trimethoxysilyl) propyl] succinic anhydride after with glycerol phosphocholine, maleic anhydride reaction and obtain modified mica sheet;1.4-pyrazine dimethylaldehyde and 4-amino-3-mercapto benzoic acid are reacted and copolymer is obtained;Then caprolactam, 1,4-diamino-2,5-divinyl benzene and copolymer are reacted and polyamide particle is obtained;Polyamide particle and modified mica sheet are reacted and medical high-barrier packaging film is obtained.The medical high-barrier packaging film prepared by the application has excellent barrier property, antifouling property, antibacterial property and mechanical property.

Description

Technical Field

[0001] This invention relates to the field of packaging films, specifically to a medical high-barrier packaging film and its preparation method. Background Technology

[0002] With the development of modern medical systems, polymer materials have played a crucial role in the field of medical products, and the market for medical packaging materials has expanded unprecedentedly. The healthcare industry's demand for medical packaging products is showing a rapid and continuous growth trend, requiring not only basic indicators such as mechanical strength, thermal stability, and moisture resistance, but also various specific requirements for protective medical packaging. For example, medical product packaging must form a sterile barrier, allow selective permeability of disinfectants, possess a certain degree of pressure resistance, and be designed with specific protective functions according to the product's transportation requirements to prevent contamination.

[0003] Currently, medical plastic packaging accounts for about one-tenth of the medical packaging market and continues to grow annually. Commonly used medical packaging materials in China include medical gauze, meltblown nonwoven fabric, medical paper-plastic bags, and crepe paper. In the development of medical packaging products, high-barrier packaging materials, due to their high strength, good barrier properties, light weight, and high elasticity, can prevent microbial penetration and achieve a sterile packaging environment, becoming a major development trend in medical packaging in recent years. With the gradual advancement of medical plastic film materials and composite film materials, as well as the upgrading of medical blister packs and packaging equipment, such packaging materials have significant advantages in the packaging industry. Therefore, this invention prepares a medical packaging film with excellent barrier properties. Summary of the Invention

[0004] The purpose of this invention is to provide a medical high-barrier packaging film and its preparation method to solve the problems existing in the prior art.

[0005] To solve the above-mentioned technical problems, the present invention provides the following technical solution:

[0006] A medical high-barrier packaging film, wherein the medical high-barrier packaging film is obtained by reacting polyamide particles and modified mica sheets.

[0007] As an optimization, the modified mica sheet is obtained by grafting [3-(trimethoxysilyl)propyl]succinic anhydride onto mica sheet and then reacting it with glycerophosphate choline and maleic anhydride.

[0008] As an optimization, the mica sheet is model WM-100 and comes from Lingshou County Huajing Mica Co., Ltd.

[0009] As an optimization, the polyamide particles are obtained by reacting caprolactam, 1,4-diamino-2,5-divinylbenzene, and a copolymer.

[0010] As an optimization, the copolymer is obtained by reacting 1,4-pyrazinedicarboxaldehyde and 4-amino-3-mercaptobenzoic acid.

[0011] A method for preparing a medical high-barrier packaging film includes the following preparation steps:

[0012] (1) Mix mica sheets, ammonia and anhydrous ethanol at a mass ratio of 1:(0.05~0.15):(8~10) and sonicate for 5~15 min to obtain an activation solution; mix [3-(trimethoxysilyl)propyl]succinic anhydride, dichloromethane and deionized water at a mass ratio of 1:(6~8):(6~8) and hydrolyze at 20~30℃ for 55~65 min to obtain a silane solution; mix the activation solution and the silane solution at a volume ratio of 1:(0.08~0.10) and sonicate at 75~85℃ for 4~6 h, cool and filter, wash with deionized water 3~5 times, and dry at 115~125℃ for 1~3 h to obtain pre-modified mica sheets;

[0013] (2) Mix the pre-modified mica sheets, glycerophosphate choline, maleic anhydride, fluorobutyl sulfonyl peptide imine and tetrahydrofuran in a mass ratio of 1:(1.1~1.3):(0.3~0.5):(0.03~0.04):(9~11), stir at 75~85℃ and 100~300rpm for 4~6h, cool and centrifuge, wash with anhydrous hexane 3~5 times, and dry at 65~75℃ for 11~13h to obtain modified mica sheets;

[0014] (3) Mix 1,4-pyrazine dicarboxaldehyde, 4-amino-3-mercaptobenzoic acid, sodium bisulfate and deionized water in a mass ratio of 1:(2.3~2.5):(6~7):(27~29), reflux at 80~100℃ for 1~2h, and extract and concentrate with dichloromethane to obtain copolymer;

[0015] (4) Mix caprolactam, 1,4-diamino-2,5-divinylbenzene, copolymer and deionized water in a mass ratio of 1:(0.6~0.8):(1~3):(0.04~0.06), heat to 220~230℃ in a nitrogen atmosphere at 85~95℃ and 100~200rpm for 2~4h, hold at 1.9~2.1MPa for 3~5h, heat to 245~255℃ at normal pressure and hold for 1~3h, then cool and granulate to obtain polyamide granules;

[0016] (5) Mix polyamide particles, modified mica sheets and azobisisobutyronitrile at a mass ratio of 1:(0.02~0.04):(0.01~0.02), and extrude the mixture using a twin-screw extruder at 220~230℃. Then, extrude the mixture to a thickness of 110~130μm using a casting machine at screw speeds of 32~34rpm, 255~265℃, 265~275℃, 270~280℃, 275~285℃, 275~285℃, and 275~285℃. Finally, allow the mixture to stand at 95~105℃ for 7~9h to obtain a high-barrier medical packaging film.

[0017] As an optimization, the reaction equation for the pre-modified mica sheet in step (1) is:

[0018] .

[0019] As an optimization, the reaction equation for the modified mica sheet in step (2) is:

[0020] .

[0021] As an optimization, the reaction equation of the copolymer in step (3) is:

[0022] .

[0023] As an optimization, the reaction equation for the polyamide particles in step (4) is:

[0024] .

[0025] Compared with the prior art, the beneficial effects achieved by the present invention are:

[0026] In preparing a medical high-barrier packaging film, this invention involves grafting [3-(trimethoxysilyl)propyl]succinic anhydride onto mica sheets and reacting it with glycerophosphate choline and maleic anhydride to obtain modified mica sheets; reacting 1,4-pyrazine dicarboxaldehyde and 4-amino-3-mercaptobenzoic acid to obtain a copolymer; then reacting caprolactam, 1,4-diamino-2,5-divinylbenzene, and the copolymer to obtain polyamide particles; and finally reacting the polyamide particles with the modified mica sheets to obtain the medical high-barrier packaging film.

[0027] First, modified mica sheets are obtained by grafting [3-(trimethoxysilyl)propyl]succinic anhydride onto mica sheets and then reacting them with glycerophosphate choline and maleic anhydride. Using the two-dimensional sheet-like structure of the mica sheets as fillers, a highly oriented arrangement is formed, increasing intermolecular forces and constructing a physical barrier. Grafting [3-(trimethoxysilyl)propyl]succinic anhydride forms a silane long-chain protective layer on the mica sheet surface, strengthening the steric hindrance effect, enhancing the dispersibility of the mica sheets, and improving the barrier properties of the medical packaging film. Then, glycerophosphate choline and carbon-carbon double bonds are introduced onto the mica sheet surface through the condensation of anhydrides and glycols. The strong hydration of phosphate choline eliminates the adhesion of proteins and microorganisms to the material surface, improving the antifouling properties of the medical packaging film. Simultaneously, the carbon-carbon double bonds can participate in polymerization, forming a cross-linked network and improving the mechanical properties of the medical packaging film.

[0028] Secondly, 1,4-pyrazinedicarboxaldehyde and 4-amino-3-mercaptobenzoic acid are reacted to obtain a copolymer; then caprolactam, 1,4-diamino-2,5-divinylbenzene, and the copolymer are reacted to obtain polyamide particles; the polyamide particles are reacted with modified mica sheets to obtain a high-barrier medical packaging film; the reaction of 1,4-pyrazinedicarboxaldehyde and 4-amino-3-mercaptobenzoic acid forms a bisbenzothiazolyl pyrazine fused ring system. The rigid planar structure and the stacking of conjugated π bonds enhance the labyrinth effect, prolong the gas diffusion path, and improve the quality of the medical packaging film. The barrier properties are enhanced; simultaneously, both pyrazine and benzothiazole structures are bioactive pharmacophores. The rigid planar structure can insert into the bacterial cell membrane, disrupting its integrity. The conjugated molecule can act as a photosensitizer under light, transferring energy to oxygen in the environment to generate reactive oxygen species, which oxidize and damage bacterial cell components, thereby improving the antibacterial properties of the medical packaging film. By utilizing 1,4-diamino-2,5-divinylbenzene to participate in the polymerization of the polyamide backbone, carbon-carbon double bonds are introduced, participating in double bond crosslinking to form a crosslinking network, thus improving the mechanical properties of the medical packaging film. Detailed Implementation

[0029] The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0030] The raw materials used in the following examples and comparative examples are all commercially available:

[0031] The mica sheet is model WM-100 and comes from Lingshou County Huajing Mica Co., Ltd.

[0032] Example 1: A method for preparing a medical high-barrier packaging film, the method comprising the following preparation steps:

[0033] (1) Mix mica sheets, ammonia and anhydrous ethanol at a mass ratio of 1:0.05:8 and sonicate for 5 min to obtain an activation solution; mix [3-(trimethoxysilyl)propyl]succinic anhydride, dichloromethane and deionized water at a mass ratio of 1:6:6 and hydrolyze at 20℃ for 65 min to obtain a silane solution; mix the activation solution and the silane solution at a volume ratio of 1:0.08 and sonicate at 75℃ for 6 h, cool and filter, wash with deionized water 3 times, and dry at 115℃ for 3 h to obtain pre-modified mica sheets;

[0034] (2) The pre-modified mica sheets, glycerophosphate choline, maleic anhydride, fluorobutyl sulfonyl peptide imine and tetrahydrofuran were mixed in a mass ratio of 1:1.1:0.3:0.03:9 and stirred at 75℃ and 100rpm for 6h. After cooling, the mixture was centrifuged, washed three times with anhydrous hexane, and dried at 65℃ for 13h to obtain the modified mica sheets.

[0035] (3) Mix 1,4-pyrazinedicarboxaldehyde, 4-amino-3-mercaptobenzoic acid, sodium bisulfate and deionized water in a mass ratio of 1:2.3:6:27, reflux at 80°C for 2 hours, and extract and concentrate with dichloromethane to obtain the copolymer;

[0036] (4) Mix caprolactam, 1,4-diamino-2,5-divinylbenzene, copolymer and deionized water in a mass ratio of 1:0.6:1:0.04. In a nitrogen atmosphere, at 85°C and 100 rpm, heat to 230°C and hold at 1.9 MPa for 3 hours. Then, heat to 245°C under normal pressure and hold for 3 hours. After cooling, granulate to obtain polyamide granules.

[0037] (5) Polyamide particles, modified mica sheets and azobisisobutyronitrile are mixed at a mass ratio of 1:0.02:0.01, and extruded at 220°C using a twin-screw extruder. The mixture is then cast to a thickness of 110 μm using a casting machine at screw speeds of 32 rpm, 255°C, 265°C, 270°C, 275°C, 275°C, and 275°C. The mixture is then allowed to stand at 95°C for 9 hours to obtain a high-barrier medical packaging film.

[0038] Example 2: A method for preparing a medical high-barrier packaging film, the method comprising the following preparation steps:

[0039] (1) Mix mica sheets, ammonia and anhydrous ethanol at a mass ratio of 1:0.1:9 and sonicate for 10 min to obtain an activation solution; mix [3-(trimethoxysilyl)propyl]succinic anhydride, dichloromethane and deionized water at a mass ratio of 1:7:7 and hydrolyze at 27℃ for 60 min to obtain a silane solution; mix the activation solution and the silane solution at a volume ratio of 1:0.09 and sonicate at 80℃ for 5 h, cool and filter, wash with deionized water 4 times, and dry at 120℃ for 2 h to obtain pre-modified mica sheets;

[0040] (2) The pre-modified mica sheets, glycerophosphate choline, maleic anhydride, fluorobutyl sulfonyl peptide imine and tetrahydrofuran were mixed in a mass ratio of 1:1.2:0.4:0.035:10, stirred at 80℃ and 200rpm for 5h, cooled and centrifuged, washed 4 times with anhydrous hexane, and dried at 70℃ for 12h to obtain the modified mica sheets;

[0041] (3) Mix 1,4-pyrazine dicarboxaldehyde, 4-amino-3-mercaptobenzoic acid, sodium bisulfate and deionized water in a mass ratio of 1:2.4:6.5:28, reflux at 90°C for 1.5 h, and extract and concentrate with dichloromethane to obtain copolymer;

[0042] (4) Mix caprolactam, 1,4-diamino-2,5-divinylbenzene, copolymer and deionized water in a mass ratio of 1:0.7:2:0.05. In a nitrogen atmosphere, at 90°C and 150 rpm for 3 hours, raise the temperature to 225°C and hold at 2 MPa for 4 hours. Then, raise the temperature to 250°C at normal pressure and hold for 2 hours. After cooling, cut the mixture into granules to obtain polyamide granules.

[0043] (5) Polyamide particles, modified mica sheets and azobisisobutyronitrile are mixed at a mass ratio of 1:0.03:0.015, and extruded after being blended at 225°C using a twin-screw extruder. The mixture is then cast to a thickness of 120 μm using a casting machine at screw speeds of 33 rpm, 260°C, 270°C, 275°C, 280°C, 280°C and 280°C. The mixture is then allowed to stand at 100°C for 8 hours to obtain a high-barrier medical packaging film.

[0044] Example 3: A method for preparing a medical high-barrier packaging film, the method comprising the following preparation steps:

[0045] (1) Mix mica sheets, ammonia and anhydrous ethanol at a mass ratio of 1:0.15:10 and sonicate for 15 min to obtain an activation solution; mix [3-(trimethoxysilyl)propyl]succinic anhydride, dichloromethane and deionized water at a mass ratio of 1:8:8 and hydrolyze at 30℃ for 55 min to obtain a silane solution; mix the activation solution and the silane solution at a volume ratio of 1:0.10 and sonicate at 85℃ for 4 h, cool and filter, wash with deionized water 5 times, and dry at 125℃ for 1 h to obtain pre-modified mica sheets;

[0046] (2) The pre-modified mica sheets, glycerophosphate choline, maleic anhydride, fluorobutyl sulfonyl peptide imine and tetrahydrofuran were mixed in a mass ratio of 1:1.3:0.5:0.04:11, stirred at 85℃ and 300rpm for 4h, cooled and centrifuged, washed 5 times with anhydrous hexane, and dried at 75℃ for 11h to obtain the modified mica sheets;

[0047] (3) Mix 1,4-pyrazine dicarboxaldehyde, 4-amino-3-mercaptobenzoic acid, sodium bisulfate and deionized water in a mass ratio of 1:2.5:7:29, reflux at 100°C for 1 h, and extract and concentrate with dichloromethane to obtain copolymer;

[0048] (4) Mix caprolactam, 1,4-diamino-2,5-divinylbenzene, copolymer and deionized water in a mass ratio of 1:0.8:3:0.06. In a nitrogen atmosphere, at 95°C and 200 rpm, heat to 220°C and hold at 1.9 MPa for 5 hours. Then, heat to 255°C under normal pressure and hold for 1 hour before cooling and pelletizing to obtain polyamide pellets.

[0049] (5) Polyamide particles, modified mica sheets and azobisisobutyronitrile are mixed at a mass ratio of 1:0.04:0.02, and extruded at 230°C using a twin-screw extruder. The mixture is then cast to a thickness of 130 μm using a casting machine at screw speeds of 34 rpm, 265°C, 275°C, 280°C, 285°C, 285°C, and 285°C. The mixture is then allowed to stand at 105°C for 7 hours to obtain a high-barrier medical packaging film.

[0050] Comparative Example 1: The preparation method of the medical high-barrier packaging film in Comparative Example 1 differs from that in Example 2 only in step (2). Step (2) is modified as follows: pre-modified mica sheets, choline glyphosate, fluorobutyl sulfonyl imide, and tetrahydrofuran are mixed in a mass ratio of 1:1.2:0.035:10, stirred at 80°C and 200 rpm for 5 h, cooled, centrifuged, washed four times with anhydrous hexane, and dried at 70°C for 12 h to obtain modified mica sheets. The remaining steps are the same as in Example 2.

[0051] Comparative Example 2: The preparation method of the medical high-barrier packaging film in Comparative Example 2 differs from that in Example 2 only in step (2). Step (2) is modified as follows: pre-modified mica sheets, ethylene glycol, maleic anhydride, fluorobutyl sulfonyl imide, and tetrahydrofuran are mixed in a mass ratio of 1:1.2:0.4:0.035:10, stirred at 80°C and 200 rpm for 5 h, cooled, centrifuged, washed four times with anhydrous hexane, and dried at 70°C for 12 h to obtain modified mica sheets. The remaining steps are the same as in Example 2.

[0052] Comparative Example 3: The preparation method of the medical high-barrier packaging film in Comparative Example 3 differs from that in Example 2 only in steps (3) and (4). Step (3) is omitted. Step (4) is modified as follows: caprolactam, 1,4-diamino-2,5-divinylbenzene, adipic acid, and deionized water are mixed in a mass ratio of 1:0.7:2:0.05. The mixture is heated to 225°C in a nitrogen atmosphere at 90°C and 150 rpm for 3 hours, and then held at 2 MPa for 4 hours. After heating to 250°C at normal pressure and holding for 2 hours, the mixture is cooled and granulated to obtain polyamide granules. The remaining steps are the same as in Example 2.

[0053] Test Example 1: Stain Resistance

[0054] Test method: The medical high-barrier packaging films obtained in each example and comparative example were immersed in PBS buffer for equilibration for 1 hour, transferred to 24-well cell culture plates, and 1 mL of PBS buffer with a concentration of 0.5 mg / mL bovine fibrinogen was added. The cell culture plates were transferred to a shaker and incubated overnight at 37°C and 200 rpm. After the incubation, the protein solution was removed, and the sample surface was washed with PBS buffer. 1 mL of washing buffer (1% sodium dodecyl sulfate (SDS) in PBS solution) was added, and the plates were placed on a shaker (200 rpm, 37°C) for 3 hours and then ultrasonically washed for 30 minutes. The protein concentration in the washing buffer was calculated using the micro-BCA protein quantification method to obtain the amount of protein adsorbed.

[0055] Table 1

[0056] .

[0057] A comparison of the experimental data of Examples 1-3 and Comparative Examples 1-3 in Table 1 shows that the medical high-barrier packaging film prepared by the present invention has good anti-fouling properties.

[0058] Comparative Example 2 was not grafted with glycerophosphate choline. By comparison, Examples 1, 2, and 3 showed lower protein adsorption compared to Comparative Example 2, indicating that by using acid anhydride and diol condensation, glycerophosphate choline and carbon-carbon double bonds were introduced onto the surface of mica sheets. Through the strong hydration of phosphate choline, the adhesion of proteins and microorganisms on the material surface was eliminated, thereby improving the antifouling properties of the medical packaging film.

[0059] Test Example 2: Barrier Properties

[0060] Test method: The medical high-barrier packaging films obtained in each example and comparative example were tested according to GB / T1038 using a VAC-V1 gas permeation apparatus at 23℃, 50% relative humidity, a sample diameter of 97mm, and a test area of ​​38.46cm². 2 Under certain conditions, the oxygen barrier properties of the composite film were tested.

[0061] Table 2

[0062] .

[0063] A comparison of the experimental data of Examples 1-3 and Comparative Examples 1-3 in Table 2 shows that the medical high-barrier packaging film prepared by the present invention has good barrier properties.

[0064] Comparative Example 3 yielded a copolymer by reacting ungrafted 1,4-pyrazinedicarboxaldehyde and 4-amino-3-mercaptobenzoic acid. By comparison, Examples 1, 2, and 3 showed lower oxygen permeation rates compared to Comparative Example 3, indicating that the reaction of 1,4-pyrazinedicarboxaldehyde and 4-amino-3-mercaptobenzoic acid forms a bisbenzothiazolyl pyrazine fused ring system. The rigid planar structure and the stacking of conjugated π bonds enhance the labyrinth effect, prolong the gas diffusion path, and improve the barrier properties of the medical packaging film.

[0065] Test Example 3: Antibacterial Properties

[0066] Test method: Take 0.1g of each of the medical high-barrier packaging films obtained in each example and comparative example as the test sample, incubate Escherichia coli at 37°C for 24h, and dilute to 10 g / mL. 6 To obtain colony-forming units (CFU), drop 0.1 mL of bacterial suspension onto an AGAR plate, spread it evenly with a sterilized metal wire, and incubate the plate at 37°C for 12 hours. Record the bacterial colony count N0. Add the sample to be tested to a flask containing 10 mL of diluted bacterial suspension, shake for 4 hours, and then spread 0.1 mL of the bacterial suspension evenly onto an AGAR plate. Incubate at 37°C for 12 hours and record the bacterial colony count N0. Calculate the inhibition rate = (N0 - N1) / N0 * 100%.

[0067] Table 3

[0068] .

[0069] A comparison of the experimental data from Examples 1-3 and Comparative Examples 1-3 in Table 3 reveals that the medical high-barrier packaging film prepared by the present invention has good antibacterial properties.

[0070] Comparative Example 3 yielded a copolymer by reacting ungrafted 1,4-pyrazinedicarboxaldehyde and 4-amino-3-mercaptobenzoic acid. By comparison, Examples 1, 2, and 3 showed higher antibacterial rates than Comparative Example 3, indicating that the reaction of 1,4-pyrazinedicarboxaldehyde and 4-amino-3-mercaptobenzoic acid forms a bisbenzothiazole pyrazine fused ring system. Both pyrazine and benzothiazole structures are bioactive pharmacophores. The rigid planar structure can insert into the bacterial cell membrane, disrupting its integrity. The conjugated molecule can act as a photosensitizer under light, transferring energy to oxygen in the environment to generate reactive oxygen species, oxidizing and damaging bacterial cell components, thus improving the antibacterial properties of the medical packaging film.

[0071] Test Example 4: Mechanical Properties

[0072] Test method: The medical high-barrier packaging films obtained in each embodiment and comparative example were cut into strips (100mm×150mm×15mm), and their tensile properties were tested using an electronic universal testing machine at a tensile speed of 10mm / min in accordance with GB / T1040.

[0073] Table 4

[0074] .

[0075] A comparison of the experimental data of Examples 1-3 and Comparative Examples 1-3 in Table 4 reveals that the medical high-barrier packaging film prepared by the present invention has good mechanical properties.

[0076] Comparative Example 1 was not grafted with maleic anhydride. By comparison, Examples 1, 2, and 3 showed higher tensile strength than Comparative Example 1, indicating that by using anhydride and glycol polycondensation, carbon-carbon double bonds were introduced into the mica sheet surface to participate in polymerization, forming a cross-linked network, which improved the mechanical properties of the medical packaging film.

[0077] The specific embodiments described above further illustrate the purpose, technical solution, and beneficial effects of the present invention. It should be understood that the above description is only a specific embodiment of the present invention and is not intended to limit the scope of protection of the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A medical high-barrier packaging film, characterized in that, The medical high-barrier packaging film is obtained by reacting polyamide particles and modified mica sheets; The modified mica sheet is obtained by grafting [3-(trimethoxysilyl)propyl]succinic anhydride onto mica sheet and then reacting it with glycerophosphate choline and maleic anhydride. The polyamide particles are obtained by reacting caprolactam, 1,4-diamino-2,5-divinylbenzene and copolymers. The copolymer was obtained by reacting 1,4-pyrazinedicarboxaldehyde and 4-amino-3-mercaptobenzoic acid.

2. A method for preparing a medical high-barrier packaging film, characterized in that, The preparation steps include the following: (1) Mix the activation solution and silane solution at a volume ratio of 1:(0.08~0.10), sonicate at 75~85℃ for 4~6h, cool and filter, wash with deionized water 3~5 times, and dry at 115~125℃ for 1~3h to obtain pre-modified mica sheets. (2) Mix the pre-modified mica sheets, glycerophosphate choline, maleic anhydride, catalyst and tetrahydrofuran in a mass ratio of 1:(1.1~1.3):(0.3~0.5):(0.03~0.04):(9~11), stir at 75~85℃ and 100~300rpm for 4~6h, cool and centrifuge, wash with anhydrous hexane 3~5 times, and dry at 65~75℃ for 11~13h to obtain modified mica sheets; (3) Mix 1,4-pyrazinedicarboxaldehyde, 4-amino-3-mercaptobenzoic acid, sodium bisulfate and deionized water in a mass ratio of 1:(2.3~2.5):(6~7):(27~29), reflux at 80~100℃ for 1~2h, extract and concentrate with an extractant to obtain copolymer; (4) Mix caprolactam, 1,4-diamino-2,5-divinylbenzene, copolymer and deionized water in a mass ratio of 1:(0.6~0.8):(1~3):(0.04~0.06), heat to 220~230℃ in a nitrogen atmosphere at 85~95℃ and 100~200rpm for 2~4h, hold at 1.9~2.1MPa for 3~5h, heat to 245~255℃ at normal pressure and hold for 1~3h, then cool and granulate to obtain polyamide granules; (5) Mix polyamide particles, modified mica sheets and azobisisobutyronitrile at a mass ratio of 1:(0.02~0.04):(0.01~0.02), extrude the mixture at 220~230℃ using a twin-screw extruder, and then cast it to a thickness of 110~130μm using a casting machine. Let it stand at 95~105℃ for 7~9h to obtain a medical high-barrier packaging film.

3. The method for preparing a medical high-barrier packaging film according to claim 2, characterized in that, The activation solution in step (1) is obtained by mixing mica flakes, ammonia and anhydrous ethanol in a mass ratio of 1:(0.05~0.15):(8~10) and sonicating for 5~15 minutes.

4. The method for preparing a medical high-barrier packaging film according to claim 2, characterized in that, The silane solution in step (1) is obtained by mixing [3-(trimethoxysilyl)propyl]succinic anhydride, dichloromethane and deionized water in a mass ratio of 1:(6~8):(6~8) and hydrolyzing at 20~30℃ for 55~65 min.

5. The method for preparing a medical high-barrier packaging film according to claim 2, characterized in that, The catalyst in step (2) is fluorobutyl sulfonate imine.

6. The method for preparing a medical high-barrier packaging film according to claim 2, characterized in that, The extractant in step (3) is dichloromethane.

7. The method for preparing a medical high-barrier packaging film according to claim 2, characterized in that, The extrusion casting process parameters in step (5) are: screw speed 32~34 rpm, 255~265℃, 265~275℃, 270~280℃, 275~285℃, 275~285℃, 275~285℃.