Multilayer composite polypropylene infusion film material, preparation method thereof and multi-chamber bag for infusion

Abstract

The invention discloses a multi-layer composite polypropylene infusion film material, a preparation method thereof and a multi-chamber bag for infusion, the infusion film material comprises an inner layer, a middle layer and an outer layer, the inner layer comprises ethylene-propylene-butylene ternary copolymer polypropylene and nano zinc oxide according to the mass ratio of 1: 0.2-0.5, and the middle layer comprises polypropylene oxide and nano zinc oxide according to the mass ratio of 1: 0.2-0.5. The middle layer is prepared from the following components: polypropylene random copolymer, ethylene-vinyl alcohol copolymer EVOH and styrene block copolymer SEBS in a mass ratio of (2-4): 1: (0.1-0.5), and the outer layer is prepared from homo-polypropylene PP, polyethylene glycol terephthalate PET and styrene block copolymer SEBS in a mass ratio of (2.5-3.5): (2-2.5): 1. The multi-layer composite polypropylene infusion film material has the performance of efficiently blocking gas such as water vapor, oxygen and carbon dioxide, the content of antioxidants, monomers and metal elements magnesium is not detected in material extracts, the content of aluminum is within a safe range, and the multi-layer composite polypropylene infusion film material has higher safety.

Description

Technical Field

[0001] The present invention relates to the field of pharmaceutical packaging materials, and in particular to a multi-layer composite polypropylene infusion film material, a preparation method thereof, and a multi-chamber bag for infusion. Background Art

[0002] At present, the more common infusion packaging containers on the market in China include glass infusion bottles, plastic infusion bottles, polyvinyl chloride soft bags (referred to as PVC for short), and non-PVC soft bags. As a traditional packaging container, the glass infusion bottle has advantages such as low price, high transparency, and good chemical stability. However, it has disadvantages such as large quality and volume, inconvenient transportation, complex production process, and being fragile, and gradually cannot meet people's needs. Plastic bottles overcome some of the disadvantages of glass bottles to a certain extent, but their transparency and high-temperature resistance are poor, and they are not suitable for the use of amino acid agents. Moreover, when using glass bottles and plastic bottles, an air circuit needs to be formed, and the liquid medicine drops out by the external air entering the bottle to form an internal pressure, which will increase the secondary pollution during the infusion process. To solve this problem, PVC soft bags came into being. However, PVC soft bags contain polyvinyl chloride monomers, which are not conducive to human health, and PVC soft bags contain a plasticizer, bis(2-ethylhexyl) phthalate (DEHP). This substance is easily dissolved and infiltrated into the medicine and then enters the human body, which will cause harmful effects on the human body.

[0003] Polypropylene (PP) materials have advantages such as few precipitates, small drug adsorption, non-toxic and environmentally friendly, etc., and are suitable for use as infusion film materials in the field of pharmaceutical packaging materials. Although the upright polypropylene infusion bag does not need to form an air circuit during use, the dispensing process is still carried out in an open environment, which has potential pollution. In addition to having advantages such as good elasticity, anti-drop, high temperature resistance, good light transmittance, and good barrier performance, the multi-layer polypropylene infusion bag discharges liquid by its own deformation during use. Among them, the multi-chamber bag can pre-install multiple kinds of liquid medicines, and the infusion safety is higher.

[0004] Chinese Patent CN201220392154.6 discloses a film for a three-layer co-extruded infusion bag, which is formed by co-extrusion of a three-layer structure, and the film thickness is 180-200 μm. The three-layer materials from the outer layer to the inner layer are polypropylene, ethylene-propylene copolymer polypropylene, and ethylene-propylene-butene terpolymer polypropylene in turn. The thickness of the polypropylene in the outer layer is 25-50 μm, the thickness of the ethylene-propylene copolymer polypropylene in the middle layer is 70-110 μm, and the thickness of the ethylene-propylene-butene terpolymer polypropylene in the inner layer is 30-50 μm. From the outside to the inside, the melting points of the raw materials decrease in turn, making the heat sealing of the film more convenient and flat, and ensuring the heat sealing strength. The infusion film made by the present invention has advantages such as non-toxic, good sterilization adaptability and heat processing performance, and is suitable for intravenous infusion packaging of physiological saline, glucose, etc. However, the extract of the ethylene-propylene copolymer polypropylene in the middle layer of the technical solution is higher in xylene, and the safety when applied to the infusion bag is poor.

[0005] Chinese Patent CN201810063919.3 discloses a five-layer co-extruded infusion film for liquid-liquid multi-chamber bags and its preparation method. The film material adopts a five-layer structure. Layer A is the inner layer of the product, which is a mixture of a modified ethylene-propylene polymer and SEBS or SEPS. Layer B is the sub-inner layer of the product, which is a polyethylene layer. Layer C is the middle layer of the product, which is a polyethylene layer. Layer D is the sub-outer layer of the product, which is an ethylene methacrylate polymer. Layer E is the outer layer of the product, which is a PET copolymer. In addition to having properties such as good transparency, flexibility, and barrier properties of ordinary infusion films, it also has a weak-weld heat-sealing property with a heat-sealing strength of 5-10 N / 15 mm and a strong-weld heat-sealing property with a heat-sealing strength greater than 20 N / 15 mm. It can not only meet the process requirements of strong welding at the periphery and weak welding in the middle, ensuring complete isolation of each chamber during sterilization and storage and transportation, but also enable the weak welding in the middle to be easily opened by appropriate external force during use, separating the multi-chamber connection and liquid-liquid mixing. The product developed by this technology is composed of materials with five different structures, and the preparation process is relatively complex. The inner layer material in contact with the medicinal liquid is composed of a mixture of a modified ethylene-propylene polymer and SEBS or SEPS, and the possibility of its exudates causing medicinal liquid pollution is relatively large.

[0006] Chinese Patent CN200820153882.5 discloses a polyolefin multi-layer co-extruded infusion film. From the perspective of material composition, it has a three-layer structure. The first layer is the inner layer A, that is, the inner sealing layer, and its composition is a mixed resin composed of a polypropylene material PP and a thermoplastic elastomeric copolymer of styrene-ethylene-butene rubber-styrene copolymer SEBS, and the addition amount of SEBS in the mixed resin is 30-50 wt%. The second layer is the middle layer B, that is, the core layer, and its composition is styrene-ethylene-butene rubber-styrene copolymer SEBS. The third layer is the outer layer C, that is, the weather-resistant layer, and its composition is polypropylene PP. The thickness of the inner layer A accounts for 15-25% of the total thickness of the infusion film, the thickness of the middle layer B accounts for 50-70% of the total thickness of the infusion film, and the thickness of the outer layer C accounts for 15-25% of the total thickness of the infusion film. The utility model has the advantages of low particle number, extremely low exudates, resistance to high temperature of 121°C, low water vapor transmission rate, good transparency, and wide drug compatibility, and is a better packaging material for electrolyte infusion and nutritional infusion. The inner layer of the product developed by this technology is a mixed resin composed of a polypropylene and a thermoplastic elastomeric copolymer of styrene-ethylene-butene rubber-styrene copolymer SEBS. Due to the relatively high melting point of polypropylene, its heat-sealing performance is poor, and its transparency is also poor.

[0007] Chinese Patent CN202111398674.8 discloses a high-barrier infusion film and its preparation method. The high-barrier infusion film includes a moisture-barrier layer, a gas-barrier layer, a reinforcing layer, and an outer layer that are tightly adhered to each other from the inside out. There is an adhesive layer between adjacent layers. The components of the moisture-barrier layer include linear low-density polyethylene, cycloolefin, maleic anhydride-grafted polyethylene, and nano-zinc oxide. The components of the gas-barrier layer include polyethylene terephthalate and ethylene-vinyl alcohol copolymer. The components of the reinforcing layer include adipic acid-terephthalic acid-butylene glycol ester copolymer, polylactic acid, and glycidyl methacrylate. The components of the outer layer include polypropylene, polyester elastomer, and styrene-based block copolymer. The components of the adhesive layer include maleic anhydride copolyester and ethylene methacrylate; through the above multi-layer structure arranged in layers and the design of each layer's components, the infusion film has excellent gas and water vapor barrier properties and antibacterial ability, and at the same time also has good toughness and scratch resistance, meeting the requirements for infusion film materials. The products developed by this technology have more components and complex production processes. The moisture-barrier layer is in direct contact with the drug, and the components low-density polyethylene and maleic anhydride-grafted polyethylene used have poor safety. Summary of the Invention

[0008] The purpose of the present invention is to provide a multi-layer composite polypropylene infusion film material, which has the performance of efficiently blocking gases such as water vapor, oxygen, and carbon dioxide.

[0009] The purpose of the present invention also lies in providing a multi-layer composite polypropylene infusion film material.

[0010] The purpose of the present invention also lies in providing a multi-chamber bag for infusion.

[0011] To achieve the above purpose, the present invention provides a multi-layer composite polypropylene infusion film material, including an inner layer, an intermediate layer, and an outer layer. The components of the inner layer are ethylene-propylene-butylene terpolymerized polypropylene and nano-zinc oxide with a mass ratio of 1:0.2 - 0.5. The components of the intermediate layer are propylene-butylene random copolymerized polypropylene, ethylene-vinyl alcohol copolymer EVOH, and styrene-based block copolymer SEBS with a mass ratio of 2 - 4:1:0.1 - 0.5. The outer layer is homopolypropylene PP, polyethylene terephthalate PET, and styrene-based block copolymer SEBS with a mass ratio of 2.5 - 3.5:2 - 2.5:1.

[0012] For the composite polypropylene infusion film material of the present invention, the melt index of ethylene-propylene-butylene terpolymerized polypropylene in the inner layer components is 5.0 - 7.0 g / 10min, preferably 5.5 - 6.4 g / 10min, and the density is 0.89 - 0.94 g / cm 3, the ethylene content is 2.5 - 3.0 wt%, and the butene content is 4.0 - 5.0 wt%. This layer mainly provides the heat sealability, antibacterial property, and compatibility with the liquid medicine of the film material.

[0013] For the composite polypropylene infusion film material of the present invention, in the middle layer composition, the melt index of propylene-butene copolymerized polypropylene is 2.0 - 5.0 g / 10 min, the butene content is 4.0 - 8.0 wt%, the melt index of ethylene-vinyl alcohol copolymer EVOH is 1.0 - 4.0 g / 10 min, and the melt index of styrene block copolymer SEBS is 3.0 - 6.0 g / 10 min. The main functions of this layer are to provide the barrier property, rigidity-flexibility balance, transparency of the infusion film bag, and connection between the inner and outer layers.

[0014] For the composite polypropylene infusion film material of the present invention, in the outer layer composition, the melt index of homopolypropylene PP is 2.0 - 5.0 g / 10 min, the melt index of polyethylene terephthalate PET is 3.0 - 5.0 g / 10 min, and the melt index of styrene block copolymer SEBS is 3.0 - 5.0 g / 10 min. The main functions of this layer are to provide the weather resistance, barrier property, scratch resistance, transparency, and heat resistance during heat sealing of the infusion film bag.

[0015] For the composite polypropylene infusion film material of the present invention, the total thickness of the multi-layer composite polypropylene infusion film is 160 - 240 μm, the inner layer thickness is 20 - 40 μm, the middle layer thickness is 120 - 160 μm, and the outer layer thickness is 20 - 40 μm.

[0016] For the composite polypropylene infusion film material of the present invention, the styrene block copolymer is styrene-ethylene-butadiene-styrene block copolymer.

[0017] To achieve the above object, the present invention also provides a preparation method of the composite polypropylene infusion film material. After the inner layer, middle layer, and outer layer pellets are respectively blended, they are put into the corresponding extruder hoppers of a multi-layer co-extrusion blown film machine for co-extrusion blown film. Compressed air is used for blown film, and then the obtained product is cooled, shaped, wound, and slit. The multi-layer co-extrusion blown film machine is a conventional device in the art, and the present invention does not limit it. Those skilled in the art can select according to the actual situation; the operation means such as compressed air blown film technology, cooling, shaping, winding, and slitting are also conventional technologies in the art, and the present invention does not make specific limitations..

[0018] For the preparation method of the composite polypropylene infusion film material of the present invention, the water ring cooling conditions are: the flow rate is 500 - 700 L / H, and the temperature of purified water is 15 - 30 °C.

[0019] The preparation method of the composite polypropylene infusion film material described in the present invention blows and swells by filling the film bubble with hundred-level purified air during the process of blowing the film bubble downwards.

[0020] To achieve the above object, the present invention also provides a multi-chamber bag for infusion, which is prepared by using the above-mentioned composite polypropylene infusion film material.

[0021] When preparing the multi-chamber bag for infusion, a heat-sealing process can be adopted. The weak-welding temperature range is: the upper template is 130 - 140 °C, and the lower template is 120 - 145 °C; the strong-welding temperature range is: the upper template is 155 - 175 °C, and the lower template is 120 - 145 °C; the heat-sealing time is 1.1 s, and the heat-sealing pressure is 0.4 MPa.

[0022] Advantages of the present invention:

[0023] (1) The inner layer material has a weak-welding heat-sealing property with a heat-sealing strength of 8 - 15 N / 15 mm and a strong-welding heat-sealing property with a heat-sealing strength greater than 20 N / 15 mm, which fully meets the process requirements of strong welding at the periphery and weak welding in the middle. During use, the inner layer weak welding can be easily opened by applying appropriate external force to cut off the communication between multiple chambers and the mixing of liquid and liquid.

[0024] (2) The present invention adopts a three-layer composite structure and the main component of each layer is polypropylene material. Compared with the composition of other multi-layer co-extruded infusion membranes, polypropylene has better mechanical properties and can ensure the safety of medical infusion membranes without contaminating the drugs.

[0025] (3) After being sterilized, the composite infusion film material of the present invention has almost unchanged light transmittance, which is comparable to that of imported infusion film materials.

[0026] (4) Adopting a multi-layer co-extrusion blow and water-cooling process, the whole preparation process is simple to operate. The infusion film prepared by combining the above components with this preparation method is not easy to break or have uneven thickness during production. The prepared infusion film has excellent mechanical properties, can meet the requirements for infusion films, and has the advantages of high temperature resistance, good light transmittance, and good barrier properties, and has a wide application prospect in the field of infusion films. Description of the Drawings

[0027] Figure 1 It is a schematic structural diagram of the composite polypropylene infusion film material of the present invention. Detailed Embodiments

[0028] The present invention will be specifically described below through examples. It is necessary to point out here that the following examples are only used to further illustrate the present invention and cannot be understood as limiting the protection scope of the present invention. Those skilled in the art can make some non-essential improvements and adjustments to the present invention according to the above content of the present invention.

[0029] The raw material manufacturers and models used in the following examples are as follows:

[0030] The ethylene-propylene-diene terpolymer polypropylene is SFC750D (melt index is 6.4 g / 10 min) of Lotte Chemical Korea, TD109CF (melt index is 6.0 g / 10 min) of Borealis, and 3C30FHP (melt index is 5.5 g / 10 min) of LyondellBasell;

[0031] Zinc oxide is a commercially available product;

[0032] The propylene-butene random copolymer polypropylene is PPR-FT03-S (melt index is 3.1 g / 10 min) of Maoming Petrochemical and F5005B (melt index is 5.5 g / 10 min) of Yanshan Petrochemical;

[0033] The ethylene-vinyl alcohol copolymer EVOH is H171B (melt index is 1.7 g / 10 min), SP292B (melt index is 2.0 g / 10 min), and F104B (melt index is 4.5 g / 10 min) of Kuraray Japan respectively;

[0034] The styrene-ethylene-butadiene-styrene block copolymer SEBS is G1645 (melt index is 3.0 g / 10 min), G1652 (melt index is 2.0 g / 10 min), and G1643 (melt index is 8.0 g / 10 min) of Kraton USA respectively;

[0035] The polypropylene PP is SFO130A (melt index is 2.7 g / 10 min) of Lotte Chemical Korea, H02M (melt index is 2.2 g / 10 min) of Lanzhou Petrochemical, and 1024 (melt index is 1.8 g / 10 min) of Ningbo Formosa Plastics;

[0036] The polyethylene terephthalate PET is 9921 (melt index is 15.0 g / 10 min) and F80CC (melt index is 10.0 g / 10 min) of Eastman USA respectively.

[0037] The melt index measurement standard involved in the present invention is GB / T 3682.1—2018, and the measurement conditions are 230 °C / 2.16 kg.

[0038] Example 1

[0039] The multi-layer composite polypropylene infusion film material provided in this example includes an inner layer, an intermediate layer, and an outer layer;

[0040] Among them, the inner layer's component ethylene-propylene-diene terpolymer polypropylene is SFC750D of Lotte Chemical Korea, and its mass ratio with nano-zinc oxide is 1:0.2; the middle layer's component propylene-diene random copolymer polypropylene is PPR-FT03-S of Maoming Petrochemical, and its mass ratio with EVOH (H171B) and SEBS (G1645) is 2:1:0.2; the outer layer's component PP is SFO130A of Lotte Chemical Korea, and its mass fraction ratio with PET (9921) and SEBS (G1645) is 3.5:2.4:1; the thickness ratio of the inner layer, middle layer, and outer layer is 1:6:1; the total thickness of the infusion film is 160 μm.

[0041] Its preparation method is prepared according to the following steps: Using a multi-die co-extrusion blown film machine, adopting a multi-layer co-extrusion blown water cooling process, mixing the components of the inner layer, middle layer, and outer layer evenly respectively, adding them into the corresponding extruder hoppers for co-extrusion blown film, blowing the film with compressed air, adjusting the thickness of different layers by controlling the traction frequency of the die head, successively passing through water ring cooling, shaping, winding into a tubular film, and then slitting to obtain the infusion film. Among them, the process conditions of water ring cooling are: the flow rate is 700 L / H, the temperature of purified water is 15 °C, and the film bubble is filled with hundred-grade purified air.

[0042] Example 2

[0043] The multi-layer composite polypropylene infusion film material provided in this example includes an inner layer, a middle layer, and an outer layer;

[0044] Among them, the inner layer's component ethylene-propylene-diene terpolymer polypropylene is TD109CF of Borealis, and its mass ratio with nano-zinc oxide is 1:0.5; the middle layer's component propylene-diene random copolymer polypropylene is F5005B of Yanshan Petrochemical, and its mass ratio with EVOH (SP292B) and SEBS (G1652) is 3:1:0.5; the outer layer's component PP is H02M of Lanzhou Petrochemical, and its mass fraction ratio with PET (9921) and SEBS (G1652) is 2.5:2.2:1, and the melt index is 5.0 g / 10 min; the thickness ratio of the inner layer, middle layer, and outer layer is 1:4:1; the total thickness of the infusion film is 240 μm.

[0045] Its preparation method is prepared according to the following steps: Using a multi-die co-extrusion blown film machine, adopting a multi-layer co-extrusion blown water cooling process, mixing the components of the inner layer, middle layer, and outer layer evenly respectively, adding them into the corresponding extruder hoppers for co-extrusion blown film, blowing the film with compressed air, adjusting the thickness of different layers by controlling the traction frequency of the die head, successively passing through water ring cooling, shaping, winding into a tubular film, and then slitting to obtain the infusion film. Among them, the process conditions of water ring cooling are: the flow rate is 500 L / H, the temperature of purified water is 30 °C, and the film bubble is filled with hundred-grade purified air.

[0046] Example 3

[0047] The multi-layer composite polypropylene infusion film material provided in this example includes an inner layer, a middle layer, and an outer layer;

[0048] Among them, the component of the inner layer, ethylene-propylene-diene terpolymer polypropylene, is LyondellBasell 3C30FHP, and its mass ratio to nano-zinc oxide is 1:0.4; the component of the middle layer, propylene-diene random copolymer polypropylene, is PPR-FT03-S of Maoming Petrochemical, and its mass ratio to EVOH (F104B) and SEBS (G1643) is 3:1:0.2; the component of the outer layer, PP, is Ningbo Formosa Plastics 1024, and its mass fraction ratio to PET (F80CC) and SEBS (G1643) is 3.0:2:1; the thickness ratio of the inner layer, middle layer, and outer layer is 1:8:2; the total thickness of the infusion film is 220μm.

[0049] Its preparation method is prepared according to the following steps: using a multi-die co-extrusion blown film machine, adopting a multi-layer co-extrusion blown water cooling process, mixing the components of the inner layer, middle layer, and outer layer evenly respectively, adding them into the corresponding extruder hoppers for co-extrusion blown film, blowing the film with compressed air, adjusting the thickness of different layers by controlling the traction frequency of the die head, successively passing through water ring cooling, shaping, and winding into a cylindrical film, and then slitting to obtain the infusion film. Among them, the process conditions of water ring cooling are: the flow rate is 700L / H, the temperature of purified water is 25°C, and the film bubble is filled with class 100 purified air.

[0050] Example 4

[0051] The multi-layer composite polypropylene infusion film material provided in this example includes an inner layer, a middle layer, and an outer layer;

[0052] Among them, the component of the inner layer, ethylene-propylene-diene terpolymer polypropylene, is Borealis TD109CF, and its mass ratio to nano-zinc oxide is 1:0.4; the component of the middle layer, propylene-diene random copolymer polypropylene, is PPR-FT03-S of Maoming Petrochemical, and its mass ratio to EVOH (H171B) and SEBS (G1652) is 4:1:0.2; the component of the outer layer, PP, is SFO130A of South Korea's Lotte Chemical, and its mass fraction ratio to PET (F80CC) and SEBS (G1652) is 3.0:2.5:1; the thickness ratio of the inner layer, middle layer, and outer layer is 1:6:2; the total thickness of the infusion film is 180μm.

[0053] The preparation method is carried out according to the following steps: Using a multi-die co-extrusion blown film machine, adopting a multi-layer co-extrusion blown water-cooling process, uniformly mixing the components of the inner layer, the middle layer and the outer layer respectively, adding them into the corresponding extruder hoppers for co-extrusion blown film, blowing the film with compressed air, adjusting the thickness of different layers by controlling the traction frequency of the die head, successively cooling by a water ring, shaping, winding into a tubular film, and then slitting to obtain an infusion film. Among them, the process conditions of the water ring cooling are: the flow rate is 600 L / H, the temperature of purified water is 25 °C, and the film bubble is filled with hundred-class purified air.

[0054] Example 5

[0055] The multi-layer composite polypropylene infusion film material provided in this example includes an inner layer, a middle layer and an outer layer;

[0056] Among them, the component of the inner layer, ethylene-propylene-butylene terpolymer polypropylene, is LyondellBasell 3C30FHP, and its mass ratio to nano-zinc oxide is 1:0.4; the component of the middle layer, propylene-butylene random copolymer polypropylene, is F5005B of Yanshan Petrochemical, and its mass ratio to EVOH (H171B) and SEBS (G1643) is 3:1:0.1; the component of the outer layer, PP, is H02M of Lanzhou Petrochemical, and its mass fraction ratio to PET (9921) and SEBS (G1643) is 3.0:2.4:1; the thickness ratio of the inner layer, the middle layer and the outer layer is 3:15:4; the total thickness of the infusion film is 220 μm.

[0057] The preparation method is carried out according to the following steps: Using a multi-die co-extrusion blown film machine, adopting a multi-layer co-extrusion blown water-cooling process, uniformly mixing the components of the inner layer, the middle layer and the outer layer respectively, adding them into the corresponding extruder hoppers for co-extrusion blown film, blowing the film with compressed air, adjusting the thickness of different layers by controlling the traction frequency of the die head, successively cooling by a water ring, shaping, winding into a tubular film, and then slitting to obtain an infusion film. Among them, the process conditions of the water ring cooling are: the flow rate is 600 L / H, the temperature of purified water is 30 °C, and the film bubble is filled with hundred-class purified air.

[0058] Comparative Example 1

[0059] On the basis of Example 1, replace the ethylene-propylene-butylene terpolymer polypropylene with ethylene-propylene copolymer polypropylene (Tianjin Petrochemical RP129K, melt index is 5.0 g / 10 min), and other components and preparation methods remain unchanged.

[0060] Comparative Example 2

[0061] On the basis of Example 1, remove EVOH (H171B), and other components and preparation methods remain unchanged.

[0062] Comparative Example 3

[0063] On the basis of Example 1, replace polypropylene (PP) with ethylene-propylene-diene terpolymer polypropylene (SFC750D from Lotte Chemical Korea), and keep other components and the preparation method unchanged.

[0064] Comparative Example 4

[0065] On the basis of Example 1, replace the mass fraction ratio of propylene-butene random copolymer polypropylene, EVOH (H171B), and SEBS (G1645) in the middle layer from 2:1:0.2 to 1:1:0.2, and keep other components and the preparation method unchanged.

[0066] Comparative Example 5

[0067] On the basis of Example 1, replace the mass fraction ratio of PP, PET (9921), and SEBS (G1645) from 3.5:2.4:1 to 5:1:1, and keep other components and the preparation method unchanged.

[0068] Test Example

[0069] The water vapor transmission rate of the multilayer composite polypropylene infusion film materials prepared in Examples 1-5 and Comparative Examples 1-5 of the present application was tested for the following performance according to relevant national standards to further describe the technical effects of the present application in detail.

[0070] 1. Evaluation of barrier effect

[0071] Water vapor transmission rate: Determined with reference to the method for determining water vapor transmission rate YBB00092003-2015; nitrogen and oxygen transmission rates: Determined with reference to the method for determining gas transmission rate YBB00082003-2015. The results are shown in Table 1.

[0072] Table 1

[0073]

[0074] It can be seen that Examples 1-5 of the present invention have excellent high moisture and gas barrier properties, meeting the requirements of infusion film materials, while the moisture and gas barrier properties of Comparative Examples 1-5 are weaker than those of Examples 1-5.

[0075] 2. Evaluation of tensile strength and heat seal strength:

[0076] Tensile strength was determined with reference to YBB00112003-2015, and heat seal strength was determined with reference to YBB00122003-2015. The results are shown in Table 2.

[0077] Table 2

[0078]

[0079] As can be seen from the above table, the longitudinal / transverse tensile strength of Examples 1-5 of the present invention is >30 MPa, the strong weld strength is >20 N / 15 mm, and the weak weld strength is in the range of 8-15 N / 15 mm, meeting the requirements of the infusion film material. However, the longitudinal / transverse tensile strength, strong weld strength, and weak weld strength of Comparative Examples 1-5 are all inferior to those of the examples.

[0080] 3. Dissolution test:

[0081] The following test items are carried out with reference to the relevant test standards in YBB00102005-2015, and the results are shown in Table 3.

[0082] Table 3

[0083] Test Items pH Value Readily Oxidizable Substances (mL) Absorbance Example 1 6.40 0.23 Complies with Regulations Example 2 6.45 0.25 Complies with Regulations Example 3 6.37 0.20 Complies with Regulations Example 4 6.40 0.22 Complies with Regulations Example 5 6.35 0.24 Complies with Regulations Comparative Example 1 6.60 0.45 Does Not Comply with Regulations Comparative Example 2 6.81 0.65 Does Not Comply with Regulations Comparative Example 3 6.77 0.50 Does Not Comply with Regulations Comparative Example 4 6.82 0.48 Does Not Comply with Regulations Comparative Example 5 6.90 0.52 Does Not Comply with Regulations

[0084] As can be seen from the above table, the pH value, peroxide value, and absorbance of Examples 1-5 of the present invention all meet the requirements of the infusion film material. However, the peroxide value of Comparative Examples 1-5 is relatively high, and the absorbance does not meet the regulations.

[0085] 4. Evaluation of light transmittance before and after sterilization:

[0086] It is measured according to the ultraviolet-visible spectrophotometry (General Principles 0401, Volume IV, Chinese Pharmacopoeia 2015 Edition), and the results are shown in Table 4.

[0087] Table 4

[0088]

[0089]

[0090] As can be seen from the above table, before and after sterilization, the light transmittance of Examples 1-5 of the present invention hardly changes and remains above 94%. However, the light transmittance of Comparative Examples 1-5 before and after sterilization is lower than that of the examples.

[0091] Of course, the present invention can also have many other embodiments. Without departing from the spirit and essence of the present invention, those skilled in the art can make various corresponding changes and deformations according to the present invention, but these corresponding changes and deformations should all fall within the protection scope of the claims of the present invention.

Claims

1. A multi-layer composite polypropylene infusion film material, Characterized in that, It includes an inner layer, a middle layer and an outer layer. The composition of the inner layer is ethylene-propylene-butene terpolymer polypropylene and nano-zinc oxide with a mass ratio of 1:0.2 - 0.

5. The composition of the middle layer is propylene-butene random copolymer polypropylene, ethylene-vinyl alcohol copolymer EVOH and styrene-based block copolymer SEBS with a mass ratio of 2 - 4:1:0.1 - 0.

5. The outer layer is homopolypropylene PP, polyethylene terephthalate PET and styrene-based block copolymer SEBS with a mass ratio of 2.5 - 3.5:2 - 2.5:

1.

2. The composite polypropylene infusion film material according to claim 1, Characterized in that, The melt index of ethylene-propylene-butene terpolymer polypropylene in the inner layer component is 5.0 to 7.0 g / 10 min, preferably 5.5 to 6.4 g / 10 min, and the density is 0.89 to 0.94 g / cm 3 , the ethylene content is 2.5 to 3.0 wt%, and the butene content is 4.0 to 5.0 wt%.

3. The composite polypropylene infusion film material according to claim 1, Characterized in that, In the composition of the middle layer, the melt index of propylene-butene copolymer polypropylene is 3.0 - 6.0 g / 10min, the butene content is 4.0 - 8.0 wt%, the melt index of ethylene-vinyl alcohol copolymer EVOH is 1.0 - 4.5 g / 10min, and the melt index of styrene-based block copolymer SEBS is 2.0 - 20.0 g / 10min.

4. The composite polypropylene infusion film material according to claim 1, Characterized in that, In the composition of the outer layer, the melt index of homopolypropylene PP is 2.0 - 5.0 g / 10min, the melt index of polyethylene terephthalate PET is 10.0 - 15.0 g / 10min, and the melt index of styrene-based block copolymer SEBS is 2.0 - 20.0 g / 10min.

5. The composite polypropylene infusion film material according to claim 1, Characterized in that, The total thickness of the multi-layer composite polypropylene infusion film is 160 - 240 μm, the thickness of the inner layer is 20 - 40 μm, the thickness of the middle layer is 120 - 160 μm, and the thickness of the outer layer is 20 - 40 μm.

6. The composite polypropylene infusion film material according to claim 1, Characterized in that, The styrene-based block copolymer is styrene-ethylene-butadiene-styrene block copolymer.

7. A method for preparing the composite polypropylene infusion film material according to any one of claims 1 - 6, Characterized in that, After the inner layer, middle layer and outer layer pellets are respectively blended, they are put into the corresponding extruder hoppers of a multi-layer co-extrusion blown film machine for co-extrusion blown film. Compressed air is used for blown film, and then the obtained product is subjected to water ring cooling, shaping, winding and slitting.

8. The method for preparing the composite polypropylene infusion film material according to claim 7, Characterized in that, The water ring cooling conditions are: the flow rate is 500 - 700 L / H, and the temperature of purified water is 15 - 30 °C.

9. The method for preparing the composite polypropylene infusion film material according to claim 7, Characterized in that, During the blown film process, hundred-class purified air is used for inflation.

10. A multi-chamber bag for infusion, Characterized in that, It is prepared by using the composite polypropylene infusion film material according to any one of claims 1 - 6.

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