High-temperature-resistant film material for infusion bag and preparation method of high-temperature-resistant film material

Abstract

The invention discloses a high-temperature-resistant thin film material for an infusion bag and a preparation method of the high-temperature-resistant thin film material, and belongs to the technical field of medical packaging materials. The film comprises a five-layer structure, wherein a heat sealing layer is formed by mixed resin consisting of co-polypropylene and a polyolefin thermoplastic elastomer; the first bonding layer and the second bonding layer are made of bonding resin; the barrier layer is made of ethylene-vinyl alcohol copolymer resin; and the high-temperature-resistant structure protection layer is formed by mixed resin consisting of co-polypropylene, cycloolefin copolymer, styrene-ethylene / butylene segmented copolymer and an anti-reflection agent. The membrane material disclosed by the invention can bear high-temperature sterilization of 135 DEG C, and meets the sterilization requirements in special medical scenes and high-risk environments, so that the adaptability of the membrane for the infusion bag is improved; in addition, the membrane material also has excellent barrier property, can better protect the liquid medicine in the long-term infusion process, reduces the probability of qualitative change of the liquid medicine, and improves the medication safety.

Description

Technical Field

[0001] The invention relates to the technical field of medical packaging materials, and in particular to a high temperature resistant film material for an infusion bag and a preparation method thereof. Background Art

[0002] With the continuous advancement of medical technology and the continuous improvement of the safety performance requirements of medical products, the performance requirements of infusion bags in the medical field are becoming increasingly stringent. As an indispensable component of the medical system, infusion bags must strictly meet the requirements of sterility. In order to ensure the sterility of the product and the safety of the patient, the infusion bag usually needs to be sterilized at high temperature. At present, the conventional sterilization temperature is about 121°C, but in some special medical scenarios and high-risk environments, the infusion bag needs to be sterilized at a higher temperature (such as 135°C). Compared with traditional 121°C sterilization, 135°C high-temperature sterilization has a higher sterilization efficiency, can effectively kill heat-resistant microorganisms, shorten the sterilization time, reduce biological risks, and reduce the use of chemical sterilizers, further ensuring patient safety and improving medical efficiency.

[0003] However, infusion bags are usually made of polyvinyl chloride (PVC), polypropylene (PP), polyethylene (PE) or polyethylene naphthalate (PEN) materials, most of which can only withstand high temperatures below 121°C, and various problems will arise when they are sterilized at higher temperatures. For example, PVC materials are prone to aging at high temperatures, and plasticizers may precipitate, endangering the health of patients; PP and PE materials may soften and deform at high temperatures, affecting the structural integrity and sealing performance of infusion bags; although PEN materials have good heat resistance, they are difficult to process, costly, and have poor flexibility, resulting in uncontrollable production costs and are not suitable for large-scale medical packaging applications. Therefore, it is extremely necessary to develop new, cost-controlled, and high-temperature resistant materials suitable for use as infusion bags, so that they can maintain excellent performance under high-temperature sterilization conditions of 135°C, while also having good processability and economy.

[0004] Chinese patent CN117734268A discloses a high temperature resistant low shrinkage film and its preparation method. The film is prepared by a four-layer co-extrusion casting process, including a composite surface layer, a first core layer, a second core layer and a heat sealing layer. The outer layer is composed of three different types of polyethylene, and the middle layer is composed of polypropylene and ethylene elastomer. Although this film has a certain improvement in high temperature shrinkage, the improvement effect is limited. Secondly, its design does not include a special barrier layer, so the barrier property to oxygen and water vapor is insufficient, and it is difficult to use it for long-term storage of liquid medicine.

[0005] Chinese patent CN114889280A discloses a disposable high barrier film for intravenous nutrition infusion bags, including a three-layer structure, wherein the heat-sealing layer A is composed of a mixed resin composed of ultra-low density polyethylene and cycloolefin copolymer, the structural layer B is composed of a mixed resin composed of metallocene polyethylene and ethylene-vinyl acetate, and the outer layer is composed of modified nylon. Although the film has a high barrier property and can better protect the nutrient infusion, since its outer layer is made of modified nylon, it is prone to browning and curling when sterilized at 135°C, affecting the overall stability of the film. Chinese patent CN 105419058 A discloses a disposable film for intravenous nutrition infusion bags, which has a high barrier property and can be sterilized by gamma ray irradiation, but since its outer layer also uses nylon as the main material, it can only withstand high temperatures of 115 to 125°C, and is also prone to curling and browning when sterilized at higher temperatures. The dimensional stability is poor, and it is difficult to ensure the integrity and sealing of the infusion bag after sterilization at higher temperatures.

[0006] In summary, most of the high-temperature resistant membrane materials disclosed in the prior art can only withstand high temperatures below 125°C, and many membrane materials are difficult to combine high-temperature resistance and strong barrier properties. Using such membrane materials as medical infusion bags cannot meet the higher temperature sterilization requirements in special medical scenarios and high-risk environments. Summary of the invention

[0007] The purpose of the present invention is to solve the problems existing in the prior art such as high film preparation cost, poor dimensional stability after high-temperature treatment at 135°C, and processing difficulties. A film material for high-temperature resistant infusion bags is provided and a specific preparation method is disclosed. The outer layer of the film material is prepared by blending PP, COC, a compatibilizer and a nucleating agent. The film material is not prone to phase separation during the processing, thereby ensuring the film quality and mechanical properties. The obtained film material can withstand a high temperature of 135°C and at the same time has excellent barrier properties and drug compatibility, and can be used to make high-performance infusion bags to meet the use requirements of special scenarios.

[0008] In order to achieve the above technical objectives, the present invention is implemented through the following technical solutions: a high temperature resistant film material for infusion bags, comprising a five-layer structure, which are, from inside to outside, a heat sealing layer, a first adhesive layer, a barrier layer, a second adhesive layer and a high temperature resistant structural protective layer; the heat sealing layer is a mixed resin composed of copolymer polypropylene and polyolefin thermoplastic elastomer; the first adhesive layer and the second adhesive layer are made of adhesive resin; the barrier layer is made of ethylene-vinyl alcohol copolymer resin; the high temperature resistant structural protective layer is a mixed resin composed of copolymer polypropylene, cycloolefin copolymer, styrene-ethylene / butylene block copolymer and a permeability enhancer.

[0009] Furthermore, the shrinkage rate of the film material after sterilization at 135° C. is less than 1%.

[0010] Furthermore, the total thickness of the film material is 180-250 μm, of which the thickness ratio of the heat sealing layer is 10%-15%, the thickness ratio of the first and second adhesive layers is 3%-7%, the thickness ratio of the barrier layer is 10%, and the thickness ratio of the high temperature resistant structural protection layer is 61%-74%.

[0011] Furthermore, the heat-sealing layer is prepared by mixing 80-90 parts of copolymerized polypropylene and 10-20 parts of polyolefin thermoplastic elastomer by weight; the copolymerized polypropylene has a melt index of 5.0-8.0 g / 10 min at 230° C. and 2.16 kg, and a density of 0.87-0.92 g / cm 3 The melt index of polyolefin thermoplastic elastomer at 230°C and 2.16kg is 6.0-7.5g / 10min, and the density is 0.87-0.92g / cm 3 .

[0012] Furthermore, the high temperature resistant structural protective layer is prepared by mixing 35-65 parts of copolymerized polypropylene, 20-35 parts of cycloolefin copolymer, 5-30 parts of styrene-ethylene / butylene block copolymer and 0.035-0.065 parts of nucleating agent by weight; the copolymerized polypropylene has a melt index of 1.0-3.0 g / 10 min at 230° C. and 2.16 kg, and a density of 0.87-0.92 g / cm 3 The glass transition temperature of the cycloolefin copolymer is 140-160°C, the melt index at 230°C and 2.16kg is 3.0-8.0g / 10min, and the mass fraction of norbornene is not less than 75%; the melt index of the styrene-ethylene / butylene block copolymer at 230°C and 2.16kg is 0.8-3.0g / 10min, and the density is 0.88-0.91g / cm 3 , the nucleating agent is an α-nucleating agent.

[0013] Preferably, the cyclic olefin copolymer may be APL6015 from Mitsui & Co., the styrene-ethylene / butylene block copolymer may be one or more of Kraton's G1657, Asahi Kasei's H1062, and H1221, and the nucleating agent may be one or more of Milliken's NX8000K and Asahi Kasei's NA-21.

[0014] Furthermore, the adhesive resin has a melt index of 0.5-3.5 g / 10 min at 230° C. and 2.16 kg, and a density of 0.86-0.92 g / cm 3 .

[0015] Furthermore, the ethylene-vinyl alcohol copolymer resin has a melt index of 3.0-5.0 g / 10 min at 230° C. and 2.16 kg, and a density of 1.0-1.2 g / cm 3 .

[0016] The preparation method of the above-mentioned high temperature resistant film material for infusion bag is as follows:

[0017] (1) mixing the pretreated copolymerized polypropylene, cycloolefin copolymer and styrene-ethylene / butylene block copolymer with a nucleating agent to obtain a mixture;

[0018] (2) Melting and extruding the mixed material into granules to obtain a special material for a high temperature resistant structural protective layer;

[0019] (3) mixing copolymerized polypropylene with polyolefin thermoplastic elastomer to obtain a special material for heat-sealing layer;

[0020] (4) Using adhesive resin as the special material for the first adhesive layer and the second adhesive layer, and using ethylene-vinyl alcohol copolymer resin as the special material for the barrier layer;

[0021] (5) A high temperature resistant film material is produced by a co-extrusion blown film process. The film comprises a five-layer structure from the inside to the outside: a heat sealing layer, a first adhesive layer, a barrier layer, a second adhesive layer and a high temperature resistant structural protection layer.

[0022] Furthermore, the production equipment of the high temperature resistant film material is a five-layer co-extrusion downward blowing water-cooled film blowing unit. Before processing, the extruder die head is first heated to 180°C for insulation, and then the special materials for each layer are sucked into the corresponding extruder hopper by a vacuum suction machine. The temperature of the corresponding extruder along the direction from the feeding port to the die is set. The temperature of the heat sealing layer is 180-220°C, the temperature of the first and second adhesive layers is 180-220°C, the temperature of the barrier layer is 190-230°C, the temperature of the high temperature resistant structural protection layer is 190-240°C, and the die head temperature is 220-230°C. After reaching the set temperature, melt extrusion is carried out, and film bubbles are blown downward, which are then cold-cut through a water ring, dried by a drying system, and rolled up to obtain a film for a high temperature resistant infusion bag.

[0023] Furthermore, the special material for the heat-sealing layer is composed of 80-90 parts of copolymerized polypropylene and 10-20 parts of polyolefin thermoplastic elastomer; the melt index of the copolymerized polypropylene at 230°C and 2.16kg is 5.0-8.0g / 10min, and the density is 0.87-0.92g / cm 3 The melt index of polyolefin thermoplastic elastomer at 230°C and 2.16kg is 6.0-7.5g / 10min, and the density is 0.87-0.92g / cm 3The special material for high temperature resistant structural protective layer is composed of 35-65 parts of copolymerized polypropylene, 20-35 parts of cycloolefin copolymer, 5-30 parts of styrene-ethylene / butylene block copolymer and 0.035-0.065 parts of nucleating agent; the melt index of copolymerized polypropylene at 230°C and 2.16kg is 1.0-3.0g / 10min, and the density is 0.87-0.92g / cm 3 The glass transition temperature of the cycloolefin copolymer is 140-160°C, the melt index at 230°C and 2.16kg is 3.0-8.0g / 10min, and the mass fraction of norbornene is not less than 75%; the melt index of the styrene-ethylene / butylene block copolymer at 230°C and 2.16kg is 0.8-3.0g / 10min, and the density is 0.88-0.91g / cm 3 The nucleating agent is an α nucleating agent; the melt index of the adhesive resin at 230°C and 2.16kg is 0.5-3.5g / 10min, and the density is 0.86-0.92g / cm 3 The melt index of ethylene-vinyl alcohol copolymer resin at 230°C and 2.16kg is 3.0-5.0g / 10min, and the density is 1.0-1.2g / cm 3 .

[0024] The beneficial effects of the present invention are:

[0025] 1. The present application uses copolymerized polypropylene, cycloolefin copolymer, styrene-ethylene / butylene block copolymer and nucleating agent to prepare a film outer layer composite structure with excellent rigidity-toughness balance and transparency. The addition of nucleating agent improves the heat resistance and transparency of polypropylene resin itself, and cycloolefin copolymer further improves the heat resistance of the material. The use of compatibilizer improves the compatibility of copolymerized polypropylene and cycloolefin copolymer, which can avoid phase separation of the two materials during film processing and affect the film quality and mechanical properties, effectively improve the addition amount and processing performance of heat-resistant polymer, thereby effectively enhancing the heat resistance of the composite film and reducing the heat shrinkage rate. The film material prepared by the method disclosed in the present application can withstand high-temperature sterilization of 135°C, ensuring the sterilization requirements in special medical scenarios and high-risk environments (F0>12), and has excellent mechanical properties, optical properties and drug safety, solving the problems of poor heat resistance and easy shrinkage of existing infusion bag films;

[0026] 2. The high temperature resistant film material disclosed in the present application is not only resistant to high temperatures, but also has excellent barrier properties and drug compatibility, which can better protect the drug solution during long-term infusion, reduce the probability of qualitative changes in the drug solution, and improve the safety of medication;

[0027] 3. The film preparation process disclosed in the present application is simple, the raw material sources are wide and the purchase cost is low, which can reduce the film preparation cost and is conducive to large-scale application in the field of medical packaging. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 Schematic diagram of the structure of the high temperature resistant film material prepared in Examples 1-4, wherein 1-heat sealing layer, 2-first adhesive layer, 3-barrier layer, 4-second adhesive layer, 5-high temperature resistant structural protection layer;

[0029] Figure 2 This is the DMA analysis curve after blending 65 parts of PP, 30 parts of COC and 5 parts of SEBS. DETAILED DESCRIPTION

[0030] The following examples further illustrate the content of the present invention, but should not be construed as limiting the present invention. Without departing from the essence of the present invention, modifications and substitutions made to the methods, steps or conditions of the present invention all fall within the scope of the present invention.

[0031] The manufacturers and models of the raw materials used in the examples are as follows:

[0032] Copolymer polypropylene: Korea Hyosung R530;

[0033] Polyolefin thermoplastic elastomer: Dow 1280G;

[0034] Adhesive resin: NF529 from Mitsui Chemicals, Japan;

[0035] Ethylene-vinyl alcohol copolymer: Japan Kuraray H171B;

[0036] Cyclic olefin copolymer: APL6015 from Mitsui Chemicals, Japan;

[0037] Styrene-ethylene / butylene block copolymer: American Kraton G1657;

[0038] Nucleating agent: American Milliken polypropylene transparency enhancing nucleating agent NX8000K.

[0039] Example 1

[0040] This embodiment discloses a method for preparing a high temperature resistant thin film material, and the specific steps are as follows:

[0041] (1) Copolymer polypropylene (PP, R530) was dried in an oven at 100°C for 3 h, cycloolefin copolymer (COC, APL6015) was dried in an oven at 110°C for 4 h, and styrene-ethylene / butylene block copolymer (SEBS, G1657) was dried in an oven at 60°C for 2 h; 55 parts of dried PP, 25 parts of COC, 20 parts of SEBS and 0.05 parts of nucleating agent (NX8000K) were added to a mixer and mixed for 15 min to obtain a mixture.

[0042] (2) adding the mixed material obtained in the previous step into a twin-screw extruder for melt extrusion granulation, wherein the melting temperature range of the extrusion granulation is 210-240° C., to obtain a special material for a high temperature resistant structural protective layer;

[0043] (3) Weigh 80 parts of copolymerized polypropylene (PP, R530) and 20 parts of polyolefin thermoplastic elastomer (TPO, 1280G) as raw materials for the heat-sealing layer, put them into a mixer and blend them for 5 minutes to form a special material for the heat-sealing layer;

[0044] (4) Weighing an adhesive resin (NF529) as a special material for the first adhesive layer and the second adhesive layer; weighing an ethylene-vinyl alcohol copolymer resin (EVOH, H171B) as a special material for the barrier layer;

[0045] (5) A five-layer co-extrusion downward-blowing water-cooled film blowing unit is used for processing. The extruder die head is first heated to 180°C and kept warm. Then, the special materials for each layer are sucked into the corresponding extruder hopper by a vacuum suction machine;

[0046] (6) Set the temperature of each extruder along the direction from the feed port to the die, the temperature of the heat sealing layer extruder is 200°C, the temperature of the first and second adhesive layer extruders is 180°C, the temperature of the barrier layer extruder is 190°C, the temperature of the high temperature resistant structural protection layer extruder is 220°C, and the die head temperature is 230°C. After reaching the set temperature, melt extrusion is performed, blown down to form a film bubble, and then passed through the water ring cold cutting, drying system drying, and winding to obtain the film material for high temperature resistant infusion bag. During production, the film cylinder and the film bubble are filled with Class A purified standard air, the water ring water flow is set to 500-700L / H, and the purified water temperature is 20-50°C.

[0047] The total thickness of the film material prepared by the above method is 200μm, including a five-layer structure, which includes, from the inside to the outside, a 30μm thick heat-sealing layer, a 10μm thick first adhesive layer, a 10μm thick barrier layer, a 10μm thick second adhesive layer and a 140μm thick high temperature resistant structural protection layer.

[0048] Example 2

[0049] The difference between this embodiment and embodiment 1 is that the composition ratio of each raw material in the mixture prepared in step (1) is different. Specifically, in step (1) of this embodiment: the copolymerized polypropylene (PP, R530) is dried in an oven at 100°C for 3 hours, the cycloolefin copolymer (COC, APL6015) is dried in an oven at 110°C for 4 hours, and the styrene-ethylene / butylene block copolymer (SEBS, G1657) is dried in an oven at 60°C for 2 hours; in parts by weight, 65 parts of dried PP, 30 parts of COC, 5 parts of SEBS and 0.05 parts of nucleating agent (NX8000K) are added to a mixer and mixed for 15 minutes to obtain a mixture.

[0050] The DMA analysis curve of the mixed material prepared by blending 65 parts of PP, 30 parts of COC and 5 parts of SEBS in Example 2 is as follows: Figure 2 As shown in the figure, it can be seen that the Tanδ of the blended PP has no obvious fluctuation before 140°C, and the storage modulus is basically stable, which indicates that the mixed material has good performance at 140°C and has good thermal stability compared with conventional PP.

[0051] Example 3

[0052] The difference between this embodiment and embodiment 1 is that the composition ratio of each raw material in the mixture prepared in step (1) is different. Specifically, in step (1) of this embodiment: the copolymerized polypropylene (PP, R530) is dried in an oven at 100°C for 3 hours, the cycloolefin copolymer (COC, APL6015) is dried in an oven at 110°C for 4 hours, and the styrene-ethylene / butylene block copolymer (SEBS, G1657) is dried in an oven at 60°C for 2 hours; in parts by weight, 65 parts of dried PP, 20 parts of COC, 15 parts of SEBS and 0.05 parts of nucleating agent (NX8000K) are added to a mixer and mixed for 15 minutes to obtain a mixture.

[0053] Comparative Example 1

[0054] The difference between Comparative Example 1 and Example 1 is that the raw material composition of the mixture prepared in step (1) is different. Specifically, in step (1) of this comparative example: the copolymerized polypropylene (PP, R530) is dried in an oven at 100° C. for 3 h; 100 parts of the dried PP and 0.05 parts of a nucleating agent (NX8000K) are added to a mixer and mixed for 15 min to obtain a mixture.

[0055] Comparative Example 2

[0056] The difference between Comparative Example 2 and Example 1 is that the raw material composition of the mixture prepared in step (1) is different. Specifically, the copolymerized polypropylene (PP, R530) is dried in an oven at 100°C for 3 h, and the cycloolefin copolymer (COC, APL6015) is dried in an oven at 110°C for 4 h. In parts by weight, 65 parts of dried PP, 35 parts of COC and 0.05 parts of nucleating agent (NX8000K) are added to a mixer and mixed for 15 minutes to obtain a mixture.

[0057] Comparative Example 3

[0058] (1) Copolymer polypropylene (PP, R530) was dried in an oven at 100°C for 3 h, cycloolefin copolymer (COC, APL6015) was dried in an oven at 110°C for 4 h, and styrene-ethylene / butylene block copolymer (SEBS, G1657) was dried in an oven at 60°C for 2 h; 55 parts of dried PP, 25 parts of COC, 20 parts of SEBS and 0.05 parts of nucleating agent (NX8000K) were added to a mixer and mixed for 15 min to obtain a mixture.

[0059] (2) adding the mixed material obtained in the previous step into a twin-screw extruder for melt extrusion granulation, wherein the melting temperature range of the extrusion granulation is 210-240° C., to obtain a special material for a high temperature resistant structural protective layer;

[0060] (3) Weigh 80 parts of copolymerized polypropylene (PP, R530) and 20 parts of polyolefin thermoplastic elastomer (TPO, 1280G) as raw materials for the heat-sealing layer, put them into a mixer and blend them for 5 minutes to form a special material for the heat-sealing layer;

[0061] (4) Weighing an adhesive resin (NF529) as a special material for the adhesive layer;

[0062] (5) A three-layer co-extrusion downward-blowing water-cooled film blowing unit is used for processing. The extruder die head is first heated to 180°C and kept warm. Then, the special materials for each layer are sucked into the corresponding extruder hopper by a vacuum suction machine;

[0063] (6) Set the temperature of each extruder along the direction from the feed port to the die, the temperature of the heat sealing layer extruder is 200°C, the temperature of the adhesive layer extruder is 180°C, the temperature of the high temperature resistant structural protection layer extruder is 220°C, and the die head temperature is 230°C. After reaching the set temperature, melt extrusion is performed, blown down to form a film bubble, and then passed through the water ring cold cutting, drying system drying, and winding to obtain the film material for high temperature resistant infusion bag. During production, the film cylinder and the film bubble are filled with Class A purified standard air, the water ring water flow rate is set to 500-700L / H, and the purified water temperature is 20-50°C.

[0064] The film material prepared by the above method has a total thickness of 180 μm and includes a three-layer structure, which includes, from the inside to the outside, a 30 μm thick heat-sealing layer, a 10 μm thick adhesive layer and a 140 μm thick high-temperature resistant structural protection layer.

[0065] The difference between this comparative example and Example 1 is that the obtained film material has only a three-layer structure, and lacks a barrier layer compared to the film material prepared in Example 1.

[0066] The components of the special materials for high temperature resistant protective layers prepared in Examples 1-3 and Comparative Example 1 are shown in Table 1.

[0067] Table 1. Composition of special materials for high temperature resistant protective layer of Examples 1-3 and Comparative Example 1

[0068]

[0069] The film materials prepared in the above embodiments and comparative examples were tested with reference to the methods and indicators specified in the standard YBB00342002-2015 "General Rules for Multilayer Co-extruded Infusion Films and Bags". At the same time, a polypropylene (PP) film with a thickness of 200 μm was tested. The test results are compared in Table 2.

[0070] Table 2

[0071]

[0072]

[0073] As can be seen from Table 2, the gas permeation of the membrane material prepared by the method disclosed in the embodiment is significantly reduced. Compared with the PP film, it has better protection for the drug solution during long-term infusion, can reduce the probability of drug solution deterioration, and improve the safety of medication. In addition, the membrane material prepared in the embodiment has a small shrinkage rate after high-temperature sterilization at 135°C and no obvious deformation. The membrane material is used to prepare medical products, which can meet the sterilization requirements in special medical scenarios and high-risk environments, and help improve patient safety and medical efficiency.

Claims

1. A high temperature resistant film material for an infusion bag, characterized in that: It includes a five-layer structure, which includes a heat-sealing layer, a first adhesive layer, a barrier layer, a second adhesive layer and a high-temperature resistant structural protection layer from the inside to the outside; The heat-sealing layer is a mixed resin composed of copolymerized polypropylene and polyolefin thermoplastic elastomer; The first adhesive layer and the second adhesive layer are made of adhesive resin; The barrier layer material is ethylene-vinyl alcohol copolymer resin; The high temperature resistant structural protective layer is a mixed resin composed of copolymerized polypropylene, cycloolefin copolymer, styrene-ethylene / butylene block copolymer and a permeability enhancer.

2. A high temperature resistant film material for an infusion bag as claimed in claim 1, characterized in that: The shrinkage rate of the film material after sterilization at 135°C is less than 1%.

3. The high temperature resistant film material for an infusion bag according to claim 1, characterized in that: The total thickness of the film material is 180-250 μm, of which the thickness ratio of the heat sealing layer is 10%-15%, the thickness ratio of the first and second adhesive layers are both 3%-7%, the thickness ratio of the barrier layer is 10%, and the thickness ratio of the high temperature resistant structural protection layer is 61%-74%.

4. The high temperature resistant film material for an infusion bag according to claim 1, characterized in that: The heat-sealing layer is prepared by mixing 80-90 parts of copolymerized polypropylene and 10-20 parts of polyolefin thermoplastic elastomer by weight; the melt index of the copolymerized polypropylene at 230°C and 2.16kg is 5.0-8.0g / 10min, and the density is 0.87-0.92g / cm 3 The melt index of polyolefin thermoplastic elastomer at 230°C and 2.16kg is 6.0-7.5g / 10min, and the density is 0.87-0.92g / cm 3 .

5. The high temperature resistant film material for an infusion bag according to claim 1, characterized in that: The high temperature resistant structural protective layer is prepared by mixing 35-65 parts of copolymerized polypropylene, 20-35 parts of cycloolefin copolymer, 5-30 parts of styrene-ethylene / butylene block copolymer and 0.035-0.065 parts of nucleating agent by weight; the melt index of the copolymerized polypropylene at 230°C and 2.16kg is 1.0-3.0g / 10min, and the density is 0.87-0.92g / cm 3 The glass transition temperature of the cycloolefin copolymer is 140-160°C, the melt index at 230°C and 2.16kg is 3.0-8.0g / 10min, and the mass fraction of norbornene is not less than 75%; the melt index of the styrene-ethylene / butylene block copolymer at 230°C and 2.16kg is 0.8-3.0g / 10min, and the density is 0.88-0.91g / cm 3 , the nucleating agent is an α-nucleating agent.

6. The high temperature resistant film material for an infusion bag according to claim 1, characterized in that: The melt index of the adhesive resin at 230°C and 2.16kg is 0.5-3.5g / 10min, and the density is 0.86-0.92g / cm 3 .

7. The high temperature resistant film material for an infusion bag according to claim 1, characterized in that: The ethylene-vinyl alcohol copolymer resin has a melt index of 3.0-5.0 g / 10 min at 230° C. and 2.16 kg, and a density of 1.0-1.2 g / cm 3 .

8. A method for preparing a high temperature resistant film material for an infusion bag according to any one of claims 1 to 7, characterized in that: The steps include: (1) mixing the pretreated copolymerized polypropylene, cycloolefin copolymer and styrene-ethylene / butylene block copolymer with a nucleating agent to obtain a mixture; (2) Melting and extruding the mixed material into granules to obtain a special material for a high temperature resistant structural protective layer; (3) mixing copolymerized polypropylene with polyolefin thermoplastic elastomer to obtain a special material for heat-sealing layer; (4) Using adhesive resin as the special material for the first adhesive layer and the second adhesive layer, and using ethylene-vinyl alcohol copolymer resin as the special material for the barrier layer; (5) A high temperature resistant film material is produced by a co-extrusion blown film process. The film comprises a five-layer structure from the inside to the outside: a heat sealing layer, a first adhesive layer, a barrier layer, a second adhesive layer and a high temperature resistant structural protection layer.

9. The method for preparing a high temperature resistant film material for an infusion bag according to claim 8, characterized in that: The production equipment of the high temperature resistant film material is a five-layer co-extrusion downward blowing water-cooled film blowing unit. Before processing, the extruder die head is first heated to 180°C for insulation, and then the special materials for each layer are sucked into the corresponding extruder hopper by a vacuum suction machine. The temperature of the corresponding extruder along the direction from the feed port to the die is set. The temperature of the heat sealing layer is 180-220°C, the temperature of the first and second adhesive layers is 180-220°C, the temperature of the barrier layer is 190-230°C, the temperature of the high temperature resistant structural protection layer is 190-240°C, and the die head temperature is 220-230°C. After reaching the set temperature, melt extrusion is carried out, and film bubbles are blown downward, which are successively cut through a water ring and dried by a drying system, and then rolled up to obtain a film for a high temperature resistant infusion bag.

10. The method for preparing a high temperature resistant film material for an infusion bag according to claim 8, characterized in that: The special material for the heat-sealing layer is composed of 80-90 parts of copolymerized polypropylene and 10-20 parts of polyolefin thermoplastic elastomer; the melt index of the copolymerized polypropylene at 230°C and 2.16kg is 5.0-8.0g / 10min, and the density is 0.87-0.92g / cm 3 The melt index of polyolefin thermoplastic elastomer at 230°C and 2.16kg is 6.0-7.5g / 10min, and the density is 0.87-0.92g / cm 3 ; The special material for high temperature resistant structural protective layer is composed of 35-65 parts of copolymerized polypropylene, 20-35 parts of cycloolefin copolymer, 5-30 parts of styrene-ethylene / butylene block copolymer and 0.035-0.065 parts of nucleating agent; the melt index of copolymerized polypropylene at 230°C and 2.16kg is 1.0-3.0g / 10min, and the density is 0.87-0.92g / cm 3 The glass transition temperature of the cycloolefin copolymer is 140-160°C, the melt index at 230°C and 2.16kg is 3.0-8.0g / 10min, and the mass fraction of norbornene is not less than 75%; the melt index of the styrene-ethylene / butylene block copolymer at 230°C and 2.16kg is 0.8-3.0g / 10min, and the density is 0.88-0.91g / cm 3 , the nucleating agent is an α-nucleating agent; The melt index of the adhesive resin at 230°C and 2.16kg is 0.5-3.5g / 10min, and the density is 0.86-0.92g / cm 3 The melt index of ethylene-vinyl alcohol copolymer resin at 230°C and 2.16kg is 3.0-5.0g / 10min, and the density is 1.0-1.2g / cm 3 .

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