High-strength multi-layer composite membrane material for medicinal packaging and preparation process of high-strength multi-layer composite membrane material

Abstract

The invention discloses a high-strength medicinal packaging multilayer composite membrane material and a preparation process thereof, and relates to the technical field of polyester composite materials, the multilayer composite membrane material sequentially comprises a heat sealing layer, a barrier layer, a bonding layer, a reinforcing layer and a printing layer from inside to outside, wherein the heat sealing layer is made of metallocene linear low density polyethylene and ethylene-vinyl acetate copolymer; the barrier layer is divided into three layers, the first layer and the third layer are made of polyethylene glycol terephthalate, and the second layer is made of ethylene-vinyl alcohol copolymer; the bonding layer is made of modified polyurethane; the reinforcing layer is made of carbon fiber reinforced polybutylene terephthalate; and the printing layer bag is made of polyethylene glycol terephthalate. Through the synergistic effect of all the layers, the medicinal packaging multilayer composite membrane material prepared by the invention has excellent heat sealing performance, barrier performance, high strength and puncture resistance, and effectively protects medicines from being influenced by the external environment.

Description

Technical Field

[0001] The present invention relates to the technical field of polyester composite materials, in particular to a high-strength multi-layer composite film material for pharmaceutical packaging and a preparation process thereof. Background Art

[0002] With the continuous development of the pharmaceutical industry, the requirements for pharmaceutical packaging materials are increasing. Pharmaceutical packaging must not only protect the drug from external environmental influences (such as moisture, oxygen, and microorganisms), but also possess a certain mechanical strength to ensure that the packaging will not be easily damaged during storage, transportation, and use, thereby ensuring the quality and safety of the drug.

[0003] Currently, common pharmaceutical packaging films on the market lack strength. For example, traditional single-layer films are prone to cracking and perforation when subjected to significant external forces or friction, rendering them ineffective in providing reliable protection for pharmaceuticals. While some multi-layer composite films offer some improvement in strength, they often suffer from complex manufacturing processes, high costs, or weak bonding between layers, leading to delamination over time and compromising packaging performance.

[0004] Furthermore, for some specialized pharmaceuticals, such as those extremely sensitive to humidity and oxygen, existing packaging films struggle to meet the stringent barrier performance requirements, leading to drug deterioration and shortened shelf life. Therefore, developing a multi-layer composite film for pharmaceutical packaging that combines high strength, excellent heat-sealing properties, excellent barrier properties, and puncture resistance is of great practical significance. Summary of the Invention

[0005] The object of the present invention is to provide a high-strength multi-layer composite film material for pharmaceutical packaging and a preparation process thereof, so as to solve the problems raised in the above background technology.

[0006] In order to solve the above technical problems, the present invention provides the following technical solutions: A high-strength multi-layer composite film material for pharmaceutical packaging, the multi-layer composite film material comprising the following structures from the inside to the outside: a heat-sealing layer, a barrier layer, an adhesive layer, a reinforcement layer and a printing layer; The heat seal layer comprises the following components by weight: 50-60 parts of metallocene linear low-density polyethylene, 10-15 parts of ethylene-vinyl acetate copolymer, 0.3-0.5 parts of antioxidant, 0.2-0.5 parts of ultraviolet absorber, and 0.5-1 parts of lubricant; The barrier layer is divided into three layers: the first layer and the third layer each include the following mass components: 30-40 parts of polyethylene terephthalate and 2-3 parts of a binder resin; the second layer includes the following mass components: 10-20 parts of an ethylene-vinyl alcohol copolymer; The adhesive layer is a modified polyurethane, and the modified polyurethane comprises the following components by mass: 93-96.5 parts of polyurethane, 3-5 parts of tackifier, and 0.5-2 parts of antioxidant; The reinforcing layer is carbon fiber reinforced polybutylene terephthalate, and the carbon fiber reinforced polybutylene terephthalate includes the following components by mass: 62-80 parts of polybutylene terephthalate, 15-30 parts of carbon fiber, 2-3 parts of toughening agent, and 3-5 parts of antioxidant; The printing layer comprises the following components by weight: 15-30 parts of polyethylene terephthalate, 2-3 parts of nano silicon dioxide, and 1-2 parts of a silane coupling agent.

[0007] Furthermore, the preparation method of carbon fiber reinforced polybutylene terephthalate comprises the following steps: Step 1: Weigh 62-80 parts of polybutylene terephthalate, 15-30 parts of carbon fiber, 2-3 parts of toughening agent, and 3-5 parts of antioxidant by weight; Step 2: Add polybutylene terephthalate, carbon fiber, toughening agent, and antioxidant into a high-pressure mixer in sequence and mix for 3-5 minutes; Step 3: adding the above mixture into the extruder hopper for melt extrusion, cooling and pelletizing to obtain the carbon fiber reinforced polybutylene terephthalate material.

[0008] Furthermore, the antioxidant is antioxidant 1010.

[0009] Furthermore, the ultraviolet absorber is ultraviolet absorber UV-328.

[0010] Furthermore, the lubricant is stearic acid.

[0011] Furthermore, the bonding resin is maleic anhydride grafted polyethylene.

[0012] Furthermore, the tackifier is a polyamide tackifier.

[0013] Furthermore, the toughening agent is toughening agent ELVALOY PTW.

[0014] Furthermore, the silane coupling agent is silane coupling agent KH-570.

[0015] Furthermore, the carbon fiber is carbon fiber T700 with a diameter of 5-6 μm.

[0016] Furthermore, the thickness of the heat sealing layer is 20-30 μm, the thickness of the barrier layer is 15-25 μm, the thickness of the adhesive layer is 3-10 μm, the thickness of the reinforcement layer is 40-60 μm, and the thickness of the printing layer is 10-20 μm.

[0017] A process for preparing a high-strength multi-layer composite film material for pharmaceutical packaging comprises the following steps: S1: respectively put the raw materials of heat seal layer, barrier layer, adhesive layer, reinforcement layer and printing layer into the corresponding extruder hopper and mix them evenly; S2: The raw materials of each layer are melted and extruded through a co-extruder and cast into a film through a die head; S3: Cooling, shaping, pulling, and rolling the film material to obtain the high-strength multi-layer composite film material for pharmaceutical packaging.

[0018] Furthermore, the melting temperature of the heat sealing layer is 105-130°C, the melting temperature of the barrier layer is 250-270°C, the melting temperature of the adhesive layer is 190-210°C, the melting temperature of the reinforcement layer is 210-230°C, and the melting temperature of the printing layer is 260-280°C.

[0019] Furthermore, the extrusion temperature of the heat sealing layer is 200-220°C, the extrusion temperature of the barrier layer is 260-280°C, the extrusion temperature of the adhesive layer is 200-220°C, the extrusion temperature of the reinforcement layer is 230-250°C, and the extrusion temperature of the printing layer is 270-290°C.

[0020] Furthermore, the cooling temperature is 15-25°C.

[0021] Furthermore, the pulling speed is 10-30 m / min.

[0022] In the above technical solution, the raw materials for the heat-sealing layer of the high-strength pharmaceutical packaging multi-layer composite film material of this application are: metallocene linear low-density polyethylene has high heat-sealing strength and good toughness, and ethylene-vinyl acetate copolymer can reduce the heat-sealing temperature. The combination of the two broadens the heat-sealing temperature window and is suitable for high-speed packaging equipment; antioxidants prevent oxidative degradation and improve thermal stability; ultraviolet absorbers protect against ultraviolet damage to drugs and materials; lubricants improve processing performance and prevent adhesion.

[0023] The raw materials for the barrier layer of the high-strength pharmaceutical packaging multi-layer composite film material in this application are: polyethylene terephthalate has good oxygen barrier properties and mechanical strength, and ethylene-vinyl alcohol copolymer is an efficient gas barrier material. The combination of the two can effectively protect the medicine; the adhesive resin is used to enhance the interlayer bonding force and ensure the stability of the composite film structure.

[0024] The raw materials for the adhesive layer of the multi-layer composite film material for high-strength pharmaceutical packaging in this application are: modified polyurethane has good bonding properties and can firmly bond the barrier layer and the reinforcing layer together; after adding a thickener, its adhesion to the surfaces of different materials is further improved, making it difficult for the layers of the composite film material to separate during long-term use; the addition of an antioxidant prevents the polyurethane from aging due to oxidation during use, thereby ensuring the stable performance of the adhesive layer.

[0025] The raw material of the reinforcing layer of the high-strength pharmaceutical packaging multi-layer composite film material in this application: carbon fiber reinforced polybutylene terephthalate has high mechanical strength, high temperature resistance and high wear resistance, meeting the requirements of pharmaceutical packaging for structural strength and high-temperature sterilization.

[0026] The raw material for the printing layer of the high-strength pharmaceutical packaging multi-layer composite film material in this application is polyethylene terephthalate as the printing substrate, which has high surface tension. After being treated with silane coupling agent KH-570, the ink has good adhesion. The addition of nano-silica can improve its transparency, strength, toughness, waterproofness and anti-aging properties.

[0027] Compared with the prior art, the beneficial effects achieved by the present invention are as follows: the various layers of materials of the present invention cooperate with each other through their own advantages, the heat-sealing layer provides sealing and preliminary protection, the barrier layer prevents gas and moisture penetration, the adhesive layer ensures that the layers are firmly connected, the reinforcement layer provides mechanical strength and stability, and the printing layer provides information and aesthetics, together constituting a high-performance, high-strength multi-layer composite film material for pharmaceutical packaging, which meets various requirements of pharmaceutical packaging in terms of protecting drug quality, extending shelf life, and facilitating use and sales. DETAILED DESCRIPTION

[0028] The following is a clear and complete description of the technical solutions in the embodiments of the present invention. Obviously, the embodiments described are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0029] In the following specific embodiments: The raw materials used in the present invention are: Metallocene linear low-density polyethylene: brand HPR3518C, density 0.918g / cm 3 , melt index 3.5g / 10min; Ethylene-vinyl acetate copolymer: brand 420, density 0.937g / cm 3 , melt index 15g / 10min; Polyethylene terephthalate: brand FR530 NC010, density 1.68g / cm 3 , melt index 0.6g / 10min; Ethylene vinyl alcohol copolymer: brand SP441B, density 1.17g / cm 3 , melt index 6.0g / 10min; Adhesive resin: Brand HP44, density 0.98g / cm 3 , melt index 8.0g / 10min; Polyurethane: Brand WG-163, density 1.16g / cm 3 , melt index 15g / 10min; Polyamide: PA6, density 1.14g / cm 3 , melt index 10g / 10min; Antioxidant: Antioxidant 1010; UV absorber: UV absorber UV-328; Lubricant stearic acid: lubricant stearic acid 1842; Polyamide tackifier: polyamide tackifier 50E739; Toughening agent: Toughening agent ELVALOYPTW; Silane coupling agent: Silane coupling agent KH-570; Carbon fiber: brand T700, diameter 5-6μm; Nano-silicon dioxide: brand XD-S07G, particle size 7-40mm.

[0030] Example 1: A process for preparing a high-strength multi-layer composite film for pharmaceutical packaging, comprising the following steps: S1: respectively put the raw materials of heat sealing layer, barrier layer, adhesive layer, reinforcement layer and printing layer into corresponding extruders; S2: The raw materials of each layer are melt-extruded through a co-extruder and cast into a film through a die head; the melting temperature of the heat sealing layer is 120°C, the melting temperature of the barrier layer is 260°C, the melting temperature of the adhesive layer is 200°C, the melting temperature of the reinforcement layer is 210°C, and the melting temperature of the printing layer is 260°C; the extrusion temperature of the heat sealing layer is 220°C, the extrusion temperature of the barrier layer is 260°C, the extrusion temperature of the adhesive layer is 220°C, the extrusion temperature of the reinforcement layer is 240°C, and the extrusion temperature of the printing layer is 270°C.

[0031] S3: Cooling, shaping, pulling, and rolling the film material, with the cooling temperature being 20° C. and the pulling speed being 10 m / min, to obtain the high-strength multi-layer composite film material for pharmaceutical packaging.

[0032] In this embodiment, the following components are included: by weight percentage: Heat seal layer: 50 parts of metallocene linear low-density polyethylene, 10 parts of ethylene-vinyl acetate copolymer, 0.3 parts of antioxidant, 0.3 parts of ultraviolet absorber, 0.6 parts of lubricant; The barrier layer is divided into three layers: the first and third layers: 35 parts polyethylene terephthalate, 2 parts bonding resin; the second layer: 10 parts ethylene vinyl alcohol copolymer; The adhesive layer is a modified polyurethane, which includes the following mass components: 95 parts of polyurethane, 4 parts of tackifier, and 1 part of antioxidant; The reinforcing layer is carbon fiber reinforced polybutylene terephthalate, which is made by the following process: Step 1: Weigh 75 parts of polybutylene terephthalate, 20 parts of carbon fiber, 2 parts of toughening agent, and 3 parts of antioxidant by weight; Step 2: Add polybutylene terephthalate, carbon fiber, toughening agent, and antioxidant into a high-speed mixer in sequence and mix for 5 minutes; Step 3: adding the above mixture into the extruder hopper for melt extrusion, cooling and pelletizing to obtain the carbon fiber reinforced polybutylene terephthalate material.

[0033] Printing layer: 20 parts of polyethylene terephthalate, 2 parts of nano-silicon dioxide, and 1.5 parts of silane coupling agent.

[0034] The thickness of the heat sealing layer is 25 μm, the thickness of the barrier layer is 20 μm, the thickness of the adhesive layer is 5 μm, the thickness of the reinforcement layer is 45 μm, and the thickness of the printing layer is 15 μm.

[0035] Example 2: A process for preparing a high-strength multi-layer composite film material for pharmaceutical packaging, comprising the following steps: S1: respectively put the raw materials of heat sealing layer, barrier layer, adhesive layer, reinforcement layer and printing layer into corresponding extruders; S2: The raw materials of each layer are melt-extruded through a co-extruder and cast into a film through a die head; the melting temperature of the heat sealing layer is 130°C, the melting temperature of the barrier layer is 270°C, the melting temperature of the adhesive layer is 190°C, the melting temperature of the reinforcement layer is 220°C, and the melting temperature of the printing layer is 270°C; the extrusion temperature of the heat sealing layer is 220°C, the extrusion temperature of the barrier layer is 260°C, the extrusion temperature of the adhesive layer is 210°C, the extrusion temperature of the reinforcement layer is 230°C, and the extrusion temperature of the printing layer is 280°C.

[0036] S3: Cooling, shaping, pulling, and rolling the film material, with the cooling temperature being 20° C. and the pulling speed being 20 m / min, to obtain the high-strength multi-layer composite film material for pharmaceutical packaging.

[0037] In this embodiment, the following components are included: by weight percentage: Heat seal layer: 55 parts metallocene linear low-density polyethylene, 13 parts ethylene-vinyl acetate copolymer, 0.3 parts antioxidant, 0.4 parts UV absorber, 0.7 parts lubricant; The barrier layer is divided into three layers: the first and third layers: 35 parts polyethylene terephthalate, 2 parts bonding resin; the second layer: 15 parts ethylene vinyl alcohol copolymer; The adhesive layer is a modified polyurethane, which includes the following mass components: 95 parts of polyurethane, 4 parts of tackifier, and 1 part of antioxidant; The reinforcing layer is carbon fiber reinforced polybutylene terephthalate, which is made by the following process: Step 1: Weigh 75 parts of polybutylene terephthalate, 20 parts of carbon fiber, 2 parts of toughening agent, and 3 parts of antioxidant by weight; Step 2: Add polybutylene terephthalate, carbon fiber, toughening agent, and antioxidant into a high-speed mixer in sequence and mix for 5 minutes; Step 3: adding the above mixture into the extruder hopper for melt extrusion, cooling and pelletizing to obtain the carbon fiber reinforced polybutylene terephthalate material.

[0038] Printing layer: 25 parts of polyethylene terephthalate, 2 parts of nano-silicon dioxide, and 2 parts of silane coupling agent.

[0039] The thickness of the heat sealing layer is 25 μm, the thickness of the barrier layer is 20 μm, the thickness of the adhesive layer is 5 μm, the thickness of the reinforcement layer is 45 μm, and the thickness of the printing layer is 15 μm.

[0040] Example 3: A process for preparing a high-strength multi-layer composite film material for pharmaceutical packaging, comprising the following steps: S1: respectively put the raw materials of heat sealing layer, barrier layer, adhesive layer, reinforcement layer and printing layer into corresponding extruders; S2: The raw materials of each layer are melted and extruded through a co-extruder and cast into a film through a die head; the melting temperature of the heat sealing layer is 105°C, the melting temperature of the barrier layer is 250°C, the melting temperature of the adhesive layer is 210°C, the melting temperature of the reinforcement layer is 230°C, and the melting temperature of the printing layer is 280°C; the extrusion temperature of the heat sealing layer is 220°C, the extrusion temperature of the barrier layer is 260°C, the extrusion temperature of the adhesive layer is 200°C, the extrusion temperature of the reinforcement layer is 250°C, and the extrusion temperature of the printing layer is 290°C.

[0041] S3: Cooling, shaping, pulling, and rolling the film material, with the cooling temperature being 25° C. and the pulling speed being 30 m / min, to obtain the high-strength multi-layer composite film material for pharmaceutical packaging.

[0042] In this embodiment, the following components are included: by weight percentage: Heat seal layer: 60 parts of metallocene linear low-density polyethylene, 15 parts of ethylene-vinyl acetate copolymer, 0.5 parts of antioxidant, 0.4 parts of ultraviolet absorber, 0.8 parts of lubricant; The barrier layer is divided into three layers: the first and third layers: 40 parts polyethylene terephthalate, 3 parts bonding resin; the second layer: 20 parts ethylene vinyl alcohol copolymer; The adhesive layer is a modified polyurethane, which includes the following mass components: 95 parts of polyurethane, 4 parts of tackifier, and 1 part of antioxidant; The reinforcing layer is carbon fiber reinforced polybutylene terephthalate, which is made by the following process: Step 1: Weigh 75 parts of polybutylene terephthalate, 20 parts of carbon fiber, 2 parts of toughening agent, and 3 parts of antioxidant by weight; Step 2: Add polybutylene terephthalate, carbon fiber, toughening agent, and antioxidant into a high-pressure mixer in sequence and mix for 5 minutes; Step 3: adding the above mixture into the extruder hopper for melt extrusion, cooling and pelletizing to obtain the carbon fiber reinforced polybutylene terephthalate material.

[0043] Printing layer: 25 parts of polyethylene terephthalate, 2 parts of nano-silicon dioxide, and 1 part of silane coupling agent.

[0044] The thickness of the heat sealing layer is 25 μm, the thickness of the barrier layer is 20 μm, the thickness of the adhesive layer is 5 μm, the thickness of the reinforcement layer is 45 μm, and the thickness of the printing layer is 15 μm.

[0045] Comparative Example 1: Based on Example 1, the barrier layer was adjusted without adding ethylene-vinyl alcohol copolymer, specifically comprising the following steps: S1: respectively put the raw materials of heat sealing layer, barrier layer, adhesive layer, reinforcement layer and printing layer into corresponding extruders; S2: The raw materials of each layer are melt-extruded through a co-extruder and cast into a film through a die head; the melting temperature of the heat sealing layer is 120°C, the melting temperature of the barrier layer is 260°C, the melting temperature of the adhesive layer is 200°C, the melting temperature of the reinforcement layer is 210°C, and the melting temperature of the printing layer is 260°C; the extrusion temperature of the heat sealing layer is 220°C, the extrusion temperature of the barrier layer is 260°C, the extrusion temperature of the adhesive layer is 220°C, the extrusion temperature of the reinforcement layer is 240°C, and the extrusion temperature of the printing layer is 270°C.

[0046] S3: Cooling, shaping, pulling, and rolling the film material, with the cooling temperature being 20° C. and the pulling speed being 10 m / min, to obtain the high-strength multi-layer composite film material for pharmaceutical packaging.

[0047] In this embodiment, the following components are included: by weight percentage: Heat seal layer: 50 parts of metallocene linear low-density polyethylene, 10 parts of ethylene-vinyl acetate copolymer, 0.3 parts of antioxidant, 0.3 parts of ultraviolet absorber, 0.6 parts of lubricant; Barrier layer: 35 parts polyethylene terephthalate, 2 parts bonding resin; The adhesive layer is a modified polyurethane, which includes the following mass components: 95 parts of polyurethane, 4 parts of tackifier, and 1 part of antioxidant; The reinforcing layer is carbon fiber reinforced polybutylene terephthalate, which is made by the following process: Step 1: Weigh 75 parts of polybutylene terephthalate, 20 parts of carbon fiber, 2 parts of toughening agent, and 3 parts of antioxidant by weight; Step 2: Add polybutylene terephthalate, carbon fiber, toughening agent, and antioxidant into a high-pressure mixer in sequence and mix for 5 minutes; Step 3: adding the above mixture into the extruder hopper for melt extrusion, cooling and pelletizing to obtain the carbon fiber reinforced polybutylene terephthalate material.

[0048] Printing layer: 20 parts of polyethylene terephthalate, 2 parts of nano-silicon dioxide, and 1.5 parts of silane coupling agent.

[0049] The thickness of the heat sealing layer is 25 μm, the thickness of the barrier layer is 20 μm, the thickness of the adhesive layer is 5 μm, the thickness of the reinforcement layer is 45 μm, and the thickness of the printing layer is 15 μm.

[0050] Comparative Example 2: Based on Example 1, the reinforcement layer is adjusted to change the carbon fiber reinforced polybutylene terephthalate to carbon polybutylene terephthalate, specifically comprising the following steps: S1: respectively put the raw materials of heat sealing layer, barrier layer, adhesive layer, reinforcement layer and printing layer into corresponding extruders; S2: The raw materials of each layer are melt-extruded through a co-extruder and cast into a film through a die head; the melting temperature of the heat sealing layer is 120°C, the melting temperature of the barrier layer is 260°C, the melting temperature of the adhesive layer is 200°C, the melting temperature of the reinforcement layer is 210°C, and the melting temperature of the printing layer is 260°C; the extrusion temperature of the heat sealing layer is 220°C, the extrusion temperature of the barrier layer is 260°C, the extrusion temperature of the adhesive layer is 220°C, the extrusion temperature of the reinforcement layer is 240°C, and the extrusion temperature of the printing layer is 270°C.

[0051] S3: Cooling, shaping, pulling, and rolling the film material, with the cooling temperature being 20° C. and the pulling speed being 10 m / min, to obtain the high-strength multi-layer composite film material for pharmaceutical packaging.

[0052] In this embodiment, the following components are included: by weight percentage: Heat seal layer: 50 parts of metallocene linear low-density polyethylene, 10 parts of ethylene-vinyl acetate copolymer, 0.3 parts of antioxidant, 0.3 parts of ultraviolet absorber, 0.6 parts of lubricant; The barrier layer is divided into three layers: the first and third layers: 35 parts polyethylene terephthalate, 2 parts bonding resin; the second layer: 10 parts ethylene vinyl alcohol copolymer; The adhesive layer is a modified polyurethane, which includes the following mass components: 95 parts of polyurethane, 4 parts of tackifier, and 1 part of antioxidant; Reinforcement layer: 40 parts polybutylene terephthalate; Printing layer: 20 parts of polyethylene terephthalate, 2 parts of nano-silicon dioxide, and 1.5 parts of silane coupling agent.

[0053] The thickness of the heat sealing layer is 25 μm, the thickness of the barrier layer is 20 μm, the thickness of the adhesive layer is 5 μm, the thickness of the reinforcement layer is 45 μm, and the thickness of the printing layer is 15 μm.

[0054] Comparative Example 3: Based on Example 1, the barrier layer was adjusted without adding a bonding resin, specifically comprising the following steps: S1: respectively put the raw materials of heat sealing layer, barrier layer, adhesive layer, reinforcement layer and printing layer into corresponding extruders; S2: The raw materials of each layer are melt-extruded through a co-extruder and cast into a film through a die head; the melting temperature of the heat sealing layer is 120°C, the melting temperature of the barrier layer is 260°C, the melting temperature of the adhesive layer is 200°C, the melting temperature of the reinforcement layer is 210°C, and the melting temperature of the printing layer is 260°C; the extrusion temperature of the heat sealing layer is 220°C, the extrusion temperature of the barrier layer is 260°C, the extrusion temperature of the adhesive layer is 220°C, the extrusion temperature of the reinforcement layer is 240°C, and the extrusion temperature of the printing layer is 270°C.

[0055] S3: Cooling, shaping, pulling, and rolling the film material, with the cooling temperature being 20° C. and the pulling speed being 10 m / min, to obtain the high-strength multi-layer composite film material for pharmaceutical packaging.

[0056] In this embodiment, the following components are included: by weight percentage: Heat seal layer: 50 parts of metallocene linear low-density polyethylene, 10 parts of ethylene-vinyl acetate copolymer, 0.3 parts of antioxidant, 0.3 parts of ultraviolet absorber, 0.6 parts of lubricant; The barrier layer is divided into three layers: the first and third layers: 35 parts polyethylene terephthalate; the second layer: 10 parts ethylene vinyl alcohol copolymer; The adhesive layer is a modified polyurethane, which includes the following mass components: 95 parts of polyurethane, 4 parts of tackifier, and 1 part of antioxidant; The reinforcing layer is carbon fiber reinforced polybutylene terephthalate, which is made by the following process: Step 1: Weigh 75 parts of polybutylene terephthalate, 20 parts of carbon fiber, 2 parts of toughening agent, and 3 parts of antioxidant by weight; Step 2: Add polybutylene terephthalate, carbon fiber, toughening agent, and antioxidant into a high-speed mixer in sequence and mix for 5 minutes; Step 3: adding the above mixture into the extruder hopper for melt extrusion, cooling and pelletizing to obtain the carbon fiber reinforced polybutylene terephthalate material.

[0057] Printing layer: 20 parts of polyethylene terephthalate, 2 parts of nano-silicon dioxide, and 1.5 parts of silane coupling agent.

[0058] The thickness of the heat sealing layer is 25 μm, the thickness of the barrier layer is 20 μm, the thickness of the adhesive layer is 5 μm, the thickness of the reinforcement layer is 45 μm, and the thickness of the printing layer is 15 μm.

[0059] Experiment: The high-strength multi-layer composite film for pharmaceutical packaging prepared in Example 1 to Comparative Example 3 was tested for performance. The composite film was prepared into a 50 mm × 50 mm sample and tested using a TST tensile testing machine at 25 ° C and 200 mm min. -1 The mechanical properties and elongation of the composite film were tested at a tensile rate of .

[0060] The composite film material was prepared into a 50mm×50mm sample and the oxygen permeability of the composite film material was tested using an OTR-D3 oxygen transmission rate tester at 25°C and a relative humidity of 50%.

[0061] The composite film material was prepared into a 50 mm × 50 mm sample, and the water vapor transmission rate of the composite film material was tested using a water vapor permeability tester W3 / 060 at 25°C and a relative humidity of 50%.

[0062] The data obtained from the performance test are shown in Table 1: Table 1 Examples and data related to contrast energy detection

[0063] Conclusion: From the comparison of the data in the table, it can be seen that in Comparative Example 1, the barrier layer does not add ethylene-vinyl alcohol copolymer, and the barrier layer is changed from a three-layer structure to a one-layer structure, and the barrier property of the composite film is the worst; in Comparative Example 2, the carbon fiber reinforced polybutylene terephthalate in the reinforcement layer is adjusted to carbon polybutylene terephthalate, and the tensile strength and elongation of the composite film are significantly reduced; in Comparative Example 3, the barrier layer does not add adhesive resin, and the tensile strength and elongation of the composite film are significantly reduced, which also affects the barrier property of the composite film.

[0064] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above and that the invention can be embodied in other specific forms without departing from the spirit or essential characteristics of the invention. Therefore, the embodiments should be considered in all respects as illustrative and non-restrictive, and the scope of the invention is defined by the appended claims rather than the foregoing description, and it is intended that all variations that come within the meaning and range of equivalents of the claims be embraced therein.

Claims

1. A high-strength multi-layer composite film material for pharmaceutical packaging, characterized by: The multi-layer composite film material comprises, from the inside to the outside, a heat sealing layer, a barrier layer, an adhesive layer, a reinforcement layer and a printing layer.

2. The high-strength multi-layer composite film material for pharmaceutical packaging according to claim 1, characterized in that: The heat sealing layer comprises the following components by weight: 50-60 parts of metallocene linear low-density polyethylene, 10-15 parts of ethylene-vinyl acetate copolymer, 0.3-0.5 parts of antioxidant, 0.2-0.5 parts of ultraviolet absorber, and 0.5-1 parts of lubricant.

3. The high-strength multi-layer composite film material for pharmaceutical packaging according to claim 1, characterized in that: The barrier layer is divided into three layers: the first layer and the third layer both include the following mass components: 30-40 parts of polyethylene terephthalate and 2-3 parts of adhesive resin; the second layer includes the following mass components: 10-20 parts of ethylene-vinyl alcohol copolymer.

4. The high-strength multi-layer composite film material for pharmaceutical packaging according to claim 1, characterized in that: The adhesive layer is modified polyurethane, and the modified polyurethane comprises the following components by mass: 93-96.5 parts of polyurethane, 3-5 parts of tackifier, and 0.5-2 parts of antioxidant.

5. The high-strength multi-layer composite film material for pharmaceutical packaging according to claim 1, characterized in that: The reinforcing layer is carbon fiber reinforced polybutylene terephthalate, and the carbon fiber reinforced polybutylene terephthalate includes the following components by mass: 62-80 parts of polybutylene terephthalate, 15-30 parts of carbon fiber, 2-3 parts of toughening agent, and 3-5 parts of antioxidant.

6. The high-strength multi-layer composite film material for pharmaceutical packaging according to claim 1, characterized in that: The printing layer comprises the following components by weight: 15-30 parts of polyethylene terephthalate, 2-3 parts of nano silicon dioxide, and 1-2 parts of a silane coupling agent.

7. The high-strength multi-layer composite film material for pharmaceutical packaging according to claim 1, characterized in that: The thickness of the heat sealing layer is 20-30 μm, the thickness of the barrier layer is 15-25 μm, the thickness of the adhesive layer is 3-10 μm, the thickness of the reinforcement layer is 40-60 μm, and the thickness of the printing layer is 10-20 μm.

8. A process for preparing a high-strength multi-layer composite film material for pharmaceutical packaging, characterized by: The following steps are involved: S1: respectively put the raw materials of heat seal layer, barrier layer, adhesive layer, reinforcement layer and printing layer into the corresponding extruder hopper and mix them evenly; S2: The raw materials of each layer are melted and extruded through a co-extrusion casting machine, and then cast into a film through a die head; S3: Cooling, shaping, pulling, and rolling the film material to obtain the high-strength multi-layer composite film material for pharmaceutical packaging.

9. The process for preparing a high-strength multi-layer composite film material for pharmaceutical packaging according to claim 8, characterized in that: The melting temperature of the heat sealing layer is 105-130°C, the melting temperature of the barrier layer is 250-270°C, the melting temperature of the adhesive layer is 190-210°C, the melting temperature of the reinforcement layer is 210-230°C, and the melting temperature of the printing layer is 260-280°C; the extrusion temperature of the heat sealing layer is 200-220°C, the extrusion temperature of the barrier layer is 260-280°C, the extrusion temperature of the adhesive layer is 200-220°C, the extrusion temperature of the reinforcement layer is 230-250°C, and the extrusion temperature of the printing layer is 270-290°C.

10. The process for preparing a high-strength multi-layer composite film material for pharmaceutical packaging according to claim 8, characterized in that: The cooling temperature is 15-25° C., and the pulling speed is 10-30 m / min.

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