A laminated film material for a transfusion soft bag and a method for manufacturing the same

Abstract

The present application relates to the technical field of film material, and provides a laminated film material for infusion soft bag, which comprises an outer layer material, a laminated layer material and an inner layer material; the laminated layer material is formed by alternately laminating an A layer and a B layer; the material of the A layer is composition A, and the material of the B layer is composition B; the components of the composition A include homopolymer polypropylene, cyclic olefin copolymer and high-density polyethylene; and the components of the composition B include copolymer polypropylene, styrene block copolymer and linear low-density polyethylene. The laminated film material for infusion soft bag and the preparation method thereof have good gas barrier property and low-temperature toughness.

Description

Technical Field

[0001] This invention relates to the technical field of membrane materials, and more specifically, to a laminated membrane material for infusion soft bags and its preparation method. Background Technology

[0002] Currently, the materials used in domestic large-volume parenteral bags are generally three-layer or five-layer co-extruded infusion films. Three-layer co-extruded infusion films are primarily made of polypropylene and formed using a co-extrusion down-blowing water-cooled blown film process. Three-layer co-extruded infusion films meet the basic requirements of infusion containers: good drug-liquid compatibility, water vapor and oxygen barrier properties, good heat-sealing strength, and certain printability and scratch resistance. Three-layer co-extruded infusion films consist of an inner layer, a middle layer, and an outer layer. These three layers serve different main functions: the inner layer provides good drug-liquid compatibility and heat-sealing performance; the outer layer provides good printability and scratch resistance; and the middle layer requires good gas barrier properties and provides support for the infusion film, possessing good mechanical properties.

[0003] As the main material for three-layer co-extruded infusion membranes, polypropylene possesses advantages such as excellent mechanical properties, good water vapor barrier properties, good chemical stability, non-toxicity, abundant raw material sources, and low price. However, polypropylene is a semi-crystalline polymer with disadvantages such as poor transparency and poor low-temperature toughness. To improve the transparency and low-temperature toughness of infusion membranes, the polypropylene in the membrane needs to be blended and modified. Styrene-based thermoplastic elastomers (such as hydrogenated styrene-butadiene block copolymers) can effectively improve the transparency and low-temperature toughness of polypropylene, so infusion membranes contain a certain proportion of these thermoplastic elastomers. While the addition of thermoplastic elastomers can improve the transparency and low-temperature toughness of polypropylene infusion membranes, it reduces the water vapor barrier properties and increases the cost. Therefore, the barrier properties and low-temperature toughness of infusion membranes are contradictory; how to balance, or even simultaneously improve, both water vapor barrier properties and low-temperature toughness has always been a challenge in the industry.

[0004] Application content

[0005] The purpose of this invention is to provide a laminated membrane material for infusion soft bags and its preparation method. The prepared laminated membrane material has good gas barrier properties and low-temperature toughness.

[0006] The embodiments of the present invention are achieved through the following technical solutions: The laminated film material for infusion soft bags of the present invention includes an outer layer material, a laminated layer material, and an inner layer material; the laminated layer material is formed by alternating layers A and B; the material of layer A is composition A, and the material of layer B is composition B; the components of composition A include homopolymer polypropylene, cyclic olefin copolymer, and high-density polyethylene; the components of composition B include copolymer polypropylene, styrene block copolymer, and linear low-density polyethylene.

[0007] Composition A is a rigid barrier material with excellent gas barrier properties; composition B is a flexible material with excellent low-temperature toughness. The rigid and flexible materials are alternately stacked using micro-nano lamination technology, with each layer as thin as a micrometer. The micrometer-level lamination enhances the barrier properties (compared to a single A / B layer, the gas needs to continuously diffuse between the barrier material and the flexible material, passing through more interface layers, thus enhancing the barrier effect). The flexible material has good low-temperature toughness, and the lamination structure effectively protects the rigid barrier material, preventing the rigid barrier material from being damaged by low-temperature impacts and affecting the overall membrane material's failure.

[0008] Composition A's main material is homopolymer polypropylene, which has good gas barrier properties and good compatibility with the outer layer material. The two layers exhibit good adhesion strength, preventing delamination. Cyclic olefin copolymers and high-density polyethylene further enhance the barrier properties. High-density polyethylene promotes the compatibility between the cyclic olefin copolymer and polypropylene, resulting in good overall mechanical properties of composition A. Composition B's main material is styrene copolymer elastomer, giving this component excellent low-temperature toughness and good compatibility with the inner layer material, resulting in high adhesion strength. The addition of partially copolymerized polypropylene improves the compatibility between composition B and composition A, facilitating partial entanglement of molecules in the interface layer and allowing the interface layer to function better. Linear low-density polyethylene further improves the low-temperature mechanical properties of composition B.

[0009] Further, by weight, composition A comprises 60-75 parts homopolymer polypropylene, 20-30 parts cyclic olefin copolymer, and 5-10 parts high-density polyethylene; composition B comprises 10-30 parts copolymer polypropylene, 60-70 parts styrene block copolymer, and 10-20 parts linear low-density polyethylene. The density of composition A is 0.890-0.980 g / cm³. 3 Under test conditions of 230℃ and 2.16 kg, the melt flow rate of the plastic was 1.5-5 g / 10 min. The density of composition B was 0.850-0.910 g / cm³. 3 Under test conditions of 230℃ and 2.16kg, the melt flow rate of the plastic was 2-6g / 10min.

[0010] Furthermore, the number of times the A layer and the B layer alternate is 2. n , where n is 4-10.

[0011] Further, the outer layer material is composition C, which, by weight, comprises 75-90 parts homopolymer polypropylene and 10-25 parts styrene block copolymer. The density of the outer layer material is 0.880-0.950 g / cm³. 3 Under test conditions of 230℃ and 2.16kg, the melt flow rate of the plastic was 2-7g / 10min.

[0012] Further, the inner layer material is composition D, which, by weight, comprises 65-80 parts of copolymer polypropylene, 5-15 parts of polyolefin elastomer, and 15-30 parts of styrene block copolymer. The density of the inner layer material is 0.880-0.930 g / cm³. 3 Under test conditions of 230℃ and 2.16kg, the melt flow rate of the plastic was 4-8g / 10min.

[0013] Further, by weight, the outer layer material comprises 10-30 parts, the laminated layer material comprises 55-75 parts, and the inner layer material comprises 10-20 parts.

[0014] Furthermore, the outer layer material has a thickness of 15-75 μm, the laminated material has a thickness of 80-180 μm, and the inner layer has a thickness of 15-50 μm; the single-layer thickness of both composition A and composition B is 1-5 μm.

[0015] The present invention also provides a method for preparing the above-mentioned laminated film material for infusion soft bags, comprising the following steps:

[0016] (1) Composition A and Composition B were prepared using a mixer and a twin-screw extruder, respectively;

[0017] (2) Composition A and Composition B are fed into different extruders at the same time. The plasticized material after extrusion is fed into the manifold at the same time. Composition A / Composition B is formed in the manifold. After passing through the multiplier, the stacked material is formed into an alternating stacked material, which is the stacked layer material.

[0018] (3) Inner layer material and outer layer material are prepared using a mixer and a twin-screw extruder, respectively;

[0019] (4) The plasticized laminated material, outer layer material and inner layer material are fed into the blown film die head, blown film and cooled to obtain laminated film material.

[0020] Furthermore, in steps (1), (2), and (3), the temperature of the first and second zones of the extruder is 120-170℃, the temperature of the third to fifth zones is 180-200℃, the temperature of the sixth to tenth zones is 200-230℃, and the temperature of the manifold and multiplier is 220-240℃; in step (4), the die temperature is 220-240℃.

[0021] The technical solution of the present invention has at least the following advantages and beneficial effects: The infusion soft bag laminated membrane material and its preparation method of the present invention utilize micro-nano lamination technology to alternately laminate two materials with different properties. Through the design of the distribution ratio of each group, the layer interface effect is utilized to achieve a good balance between the two contradictory properties of the membrane material, namely, barrier performance and low temperature toughness. It has both good gas barrier performance and low temperature toughness. Detailed Implementation

[0022] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Where specific conditions are not specified in the embodiments, conventional conditions or conditions recommended by the manufacturer shall apply. Reagents or instruments whose manufacturers are not specified are all conventional products that can be purchased commercially.

[0023] Examples 1-3

[0024] Examples 1-3 all provide laminated membrane materials for infusion soft bags and their preparation methods. The operation steps of Examples 1-3 are the same, the only difference being the content of the components. The specific steps are shown below, and the component contents of each example are shown in Table 1. The total thickness of the prepared laminated membrane material is 200 micrometers. In addition, since composition A and composition B are overlapped multiple times, the component contents of composition A and composition B recorded in Table 1 refer to the content of a single layer, not the total content (same as Tables 2-3).

[0025] (1) Compositions A, B, C and D were prepared using a high-speed mixer and a twin-screw extruder, respectively; the temperature of the first and second zones of the extruder was 150°C, the temperature of the third to fifth zones was 180°C, the temperature of the sixth to tenth zones was 200°C, and the temperature of the manifold and multiplier was 220°C.

[0026] (2) Composition A and Composition B are fed into different extruders at the same time. The plasticized material after extrusion is fed into the manifold at the same time. The manifold forms a laminate of Composition A / Composition B. After passing through the multiplier, the laminate forms an alternating laminate, which is the laminated layer material. The temperature of the first and second zones of the extruder is 150°C, the temperature of the third to fifth zones is 180°C, the temperature of the sixth to tenth zones is 200°C, and the temperature of the manifold and multiplier is 220°C.

[0027] (3) At the same time, composition C and composition D are fed into the extruder respectively, and the inner layer material and outer layer material are formed by melting and plasticizing in the extruder; the temperature of the first and second zones of the extruder is 150°C, the temperature of the third to fifth zones is 180°C, the temperature of the sixth to tenth zones is 200°C, and the temperature of the manifold and multiplier is 220°C.

[0028] (4) The plasticized laminated material, outer layer material and inner layer material are fed into the blown film die head together, blown film and cooled to obtain laminated film material. The die head temperature is 220℃.

[0029] Table 1. Components and their contents in Examples 1-3

[0030]

[0031] Comparative Example 1

[0032] Comparative Example 1 discloses a membrane material, the components and their contents are shown in Table 2 below, and the preparation steps of the membrane material are shown below:

[0033] (1) Inner layer material, outer layer material and intermediate layer material were prepared by using a high-speed mixer and a twin-screw extruder, respectively;

[0034] (2) The inner layer material, outer layer material and middle layer material are fed into the extruder respectively. After being melted and plasticized by the extruder, they are fed into the co-extrusion blown film die head, and after blowing and cooling, the film material is obtained.

[0035] Table 2 shows the components and their contents in Comparative Example 1.

[0036]

[0037] Comparative Example 2

[0038] Comparative Example 2 is a laminated membrane material, whose preparation method, components and contents are the same as those of the laminated membrane material in Example 2, except that composition A is completely replaced by composition B.

[0039] Comparative Examples 3-4

[0040] Comparative Examples 3-4 are laminated film materials, and their preparation methods are the same as those in Example 1. The difference lies in the components and their contents. The components and their contents of Comparative Examples 3-4 are shown in Table 3 below.

[0041] Table 3 shows the components and their contents in Comparative Examples 3-4.

[0042]

[0043] Experimental Example

[0044] The materials prepared in Examples 1-3 and Comparative Examples 1-4 were subjected to oxygen permeability and low-temperature tensile impact tests, and the test methods are as follows:

[0045] Water vapor transmission rate: Determined at 38℃ and 90% relative humidity according to the first method of water vapor transmission rate determination (YBB00092003-2015).

[0046] Oxygen permeability: Determined at 23℃ and 50% relative humidity according to the first method of gas permeability determination (YBB00082003-2015).

[0047] Tensile impact strength: Tested at 0℃, according to the test method for tensile impact properties of plastics (GB / T13525-1992).

[0048] The test results are shown in Table 4 below.

[0049] Table 4 Test results of Examples 1-3 and Comparative Examples 1-4

[0050]

[0051] As can be seen from the experimental data in Table 4, the laminated membrane material of this application has low water vapor permeability and oxygen permeability, and high tensile impact strength under low temperature conditions.

[0052] Comparing Example 1 and Comparative Example 1, it can be seen that when the membrane contains a multilayer, the water vapor permeability and oxygen permeability of the membrane material decrease, while the low-temperature tensile impact strength increases. Comparing Example 2 and Comparative Example 2, it can be seen that when a membrane material is made by multiplying rigid and flexible materials, compared with a membrane material made by multiplying the same composition, the water vapor permeability and oxygen permeability of the membrane material decrease, while the low-temperature tensile impact strength increases. Comparing Examples 1-3 and Comparative Examples 3-4, it can be seen that when the components and contents of the present invention and the number of times the layers are used, the membrane material has better barrier properties and low-temperature toughness.

[0053] The above are merely preferred embodiments of the present invention and are not intended to limit the present invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A laminated film material for infusion soft bags, characterized in that: It includes an outer layer material, a multilayer material, and an inner layer material; the multilayer material is composed of alternating layers A and B; the material of layer A is composition A, and the material of layer B is composition B; The components of composition A include homopolymer polypropylene, cyclic olefin copolymer, and high-density polyethylene; The components of composition B include copolymer polypropylene, styrene block copolymer, and linear low-density polyethylene; By weight, composition A comprises 60-75 parts homopolymer polypropylene, 20-30 parts cyclic olefin copolymer, and 5-10 parts high-density polyethylene; composition B comprises 10-30 parts copolymer polypropylene, 60-70 parts styrene block copolymer, and 10-20 parts linear low-density polyethylene. The number of times layer A and layer B alternate is 2. n , where n is 4-10.

2. The laminated film material for infusion soft bags according to claim 1, characterized in that: The outer layer material is composition C, which, by weight, comprises 75-90 parts of homopolymer polypropylene and 10-25 parts of styrene block copolymer.

3. The laminated film material for infusion soft bags according to claim 1, characterized in that: The inner layer material is composition D, which, by weight, comprises 65-80 parts of copolymer polypropylene, 5-15 parts of polyolefin elastomer, and 15-30 parts of styrene block copolymer.

4. The laminated film material for infusion soft bags according to claim 1, characterized in that: By weight, the outer layer material comprises 10-30 parts, the laminated layer material comprises 55-75 parts, and the inner layer material comprises 10-20 parts.

5. The laminated film material for infusion soft bags according to claim 1, characterized in that: The outer layer material has a thickness of 15-75 μm, the laminated material has a thickness of 80-180 μm, and the inner layer has a thickness of 15-50 μm; the single layer thickness of both composition A and composition B is 1-5 μm.

6. The method for preparing the laminated film material for infusion soft bags according to any one of claims 1-5, characterized in that, The following steps are included: (1) Composition A and composition B were prepared using a high-speed mixer and a twin-screw extruder, respectively; (2) Composition A and Composition B are fed into different extruders at the same time. The plasticized material after extrusion is fed into the manifold at the same time. Composition A / Composition B is formed in the manifold. After passing through the multiplier, the stacked material is formed into an alternating stacked material, which is the stacked layer material. (3) Inner layer material and outer layer material are prepared by using a high-speed mixer and a twin-screw extruder, respectively; (4) The plasticized laminated material, outer layer material and inner layer material are fed into the blown film die head, blown film and cooled to obtain laminated film material.

7. The method for preparing the laminated film material for infusion soft bags according to claim 6, characterized in that: In steps (1), (2) and (3), the temperature of the extruder in zones one and two is 120-170℃, the temperature of zones three to five is 180-200℃, the temperature of zones six to ten is 200-230℃, and the temperature of the manifold and multiplier is 220-240℃; in step (4), the temperature of the die head is 220-240℃.

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