A multilayer composite polypropylene infusion film material, a preparation method thereof, and a multi-chamber bag for infusion

Abstract

The application discloses a multilayer composite polypropylene transfusion film material, a preparation method thereof, and a multi-chamber bag for transfusion. The transfusion film material comprises an inner layer, an intermediate layer and an outer layer. The inner layer is composed of ethylene-propylene-butylene terpolymer polypropylene and nano zinc oxide with a mass ratio of 1:0.2-0.5. The intermediate layer is composed of propylene-butylene binary random copolymer polypropylene, ethylene-vinyl alcohol copolymer EVOH and styrene block copolymer SEBS with a mass ratio of 2-4:1:0.1-0.5. The outer layer is composed of homopolymer polypropylene PP, polyethylene terephthalate PET and styrene block copolymer SEBS with a mass ratio of 2.5-3.5:2-2.5:1. The multilayer composite polypropylene transfusion film material has the performance of efficiently blocking water vapor, oxygen, carbon dioxide and other gases. No antioxidant or monomer is detected in the material extract, and the contents of magnesium and aluminum are within the safety range, so that the material has higher safety.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical packaging materials, and more particularly to a multilayer composite polypropylene infusion film material, its preparation method, and a multi-chamber bag for infusion. Background Technology

[0002] Currently, the most common infusion packaging containers in my country include glass infusion bottles, plastic infusion bottles, polyvinyl chloride (PVC) flexible bags, and non-PVC flexible bags. Glass infusion bottles, as traditional packaging containers, have advantages such as low price, high transparency, and good chemical stability. However, their large size and weight make them inconvenient to transport, their complex manufacturing process, and their fragility cause them to gradually fail to meet people's needs. Plastic bottles overcome some of the disadvantages of glass bottles, but their poor transparency and high-temperature resistance make them unsuitable for amino acid-based medications. Furthermore, glass and plastic bottles require an air circuit during use, with external air entering the bottle to create internal pressure and force the medication to drip out, increasing the risk of secondary contamination during the infusion process. To address this issue, PVC flexible bags were developed. However, PVC flexible bags contain polyvinyl chloride monomer, which is detrimental to human health. Additionally, PVC flexible bags contain a plasticizer, 2-ethylhexyl phthalate (DEHP), which can easily dissolve and seep into the medication, potentially causing harm to the human body.

[0003] Polypropylene (PP) material has advantages such as low leaching, low drug adsorption, and non-toxicity, making it suitable as an infusion membrane material for pharmaceutical packaging. While upright polypropylene infusion bags do not require an air circuit during use, the medication preparation process still takes place in an open environment, posing a potential for contamination. Multi-layer polypropylene infusion bags, in addition to their advantages of good elasticity, drop resistance, high temperature resistance, good light transmittance, and good barrier properties, rely on their own deformation to drain the fluid during use. Multi-chamber bags can pre-fill various medications, resulting in higher infusion safety.

[0004] Chinese patent CN201220392154.6 discloses a three-layer co-extruded infusion bag film, which is co-extruded from three layers with a thickness of 180-200 μm. The three layers, from the outermost layer to the innermost layer, are polypropylene, ethylene-propylene binary copolymer polypropylene, and ethylene-propylene-butene terpolymer polypropylene. The outer polypropylene layer has a thickness of 25-50 μm, the middle ethylene-propylene binary copolymer polypropylene layer has a thickness of 70-110 μm, and the inner ethylene-propylene-butene terpolymer polypropylene layer has a thickness of 30-50 μm. The melting point of the raw materials decreases from the outside to the inside, making the film heat-sealing simpler and smoother, and ensuring heat-sealing strength. The infusion film produced by this invention has the advantages of being non-toxic, having good sterilization adaptability, and good heat processing performance, making it suitable for intravenous infusion packaging of physiological saline, glucose, etc. However, the middle ethylene-propylene binary copolymer polypropylene layer of this invention has a higher extractable content in xylene, resulting in poor safety when used in infusion bags.

[0005] Chinese patent CN201810063919.3 discloses a five-layer co-extruded infusion membrane for multi-chamber liquid-liquid bags and its preparation method. The membrane material employs a five-layer structure: Layer A is the inner layer, a mixture of modified ethylene-propylene polymer and SEBS or SEPS; Layer B is the second inner layer, a polyethylene layer; Layer C is the middle layer, a polyethylene layer; Layer D is the second outer layer, an ethylene methacrylate polymer; and Layer E is the outer layer, a PET copolymer. In addition to possessing the good transparency, flexibility, and barrier properties of ordinary infusion membranes, it also exhibits both weak heat-sealing performance (5-10 N / 15 mm) and strong heat-sealing performance (greater than 20 N / 15 mm). This satisfies the process requirements of strong periphery and weak central weld, ensuring complete isolation of each chamber during sterilization and storage. Furthermore, the weak central weld can be easily opened with appropriate external force during use, preventing communication between multiple chambers and liquid-liquid mixing. The product developed using this technology consists of five layers of materials with different structures, and the preparation process is relatively complex. The inner layer material that comes into contact with the drug solution is composed of a mixture of modified ethylene-propylene polymer and SEBS or SEPS, and its precipitates have a high possibility of causing drug solution contamination.

[0006] Chinese patent CN200820153882.5 discloses a polyolefin lightweight multilayer co-extruded infusion membrane, which has a three-layer structure in terms of material composition. The first layer is the inner layer A, i.e., the inner sealing layer, which is composed of a mixed resin of polypropylene (PP) and a thermoplastic elastic copolymer of styrene-ethylene-butene rubber-styrene (SEBS), with SEBS added in the mixed resin at an amount of 30-50 wt%. The second layer is the middle layer B, i.e., the core layer, which is also composed of SEBS. The third layer is the outer layer C, i.e., the weather-resistant layer, which is composed of polypropylene (PP). The thickness of the inner layer A accounts for 15-25% of the total thickness of the infusion membrane, the thickness of the middle layer B accounts for 50-70% of the total thickness, and the thickness of the outer layer C accounts for 15-25% of the total thickness. This invention possesses advantages such as low particle count, minimal exudate, resistance to high temperatures up to 121°C, low water vapor permeability, good transparency, and broad drug compatibility, making it a superior packaging material for electrolyte and nutritional infusions. The inner layer of the product developed using this technology is a mixed resin composed of polypropylene and a thermoplastic elastic copolymer of styrene-ethylene-butene rubber-styrene copolymer (SEBS). Due to the high melting point of polypropylene, its heat-sealing performance is poor, and its transparency is also relatively low.

[0007] Chinese patent CN202111398674.8 discloses a high-barrier infusion membrane and its preparation method. The high-barrier infusion membrane comprises, from the inside out, a moisture-barrier layer, a gas-barrier layer, a reinforcing layer, and an outer layer, all tightly bonded together. An adhesive layer is provided between adjacent layers. The moisture-barrier layer comprises linear low-density polyethylene, cyclic olefins, maleic anhydride-grafted polyethylene, and nano-zinc oxide. The gas-barrier layer comprises polyethylene terephthalate and ethylene-vinyl alcohol copolymer. The reinforcing layer comprises adipic acid-butylene terephthalate copolymer, polylactic acid, and glycidyl methacrylate. The outer layer comprises polypropylene, polyester elastomer, and styrene-based block copolymer. The adhesive layer comprises maleic anhydride copolyester and ethylene methacrylate. Through the multilayer structure and the design of each layer's components, the infusion membrane possesses excellent gas and water vapor barrier properties and antibacterial capabilities, while also exhibiting good toughness and scratch resistance, meeting the requirements for infusion membrane materials. The product developed using this technology has many components, a complex production process, and the moisture barrier layer is in direct contact with the drug. The components used are low-density polyethylene and maleic anhydride-grafted polyethylene, which have poor safety. Summary of the Invention

[0008] The purpose of this invention is to provide a multilayer composite polypropylene infusion membrane material, which has the ability to effectively block gases such as water vapor, oxygen, and carbon dioxide.

[0009] Another objective of this invention is to provide a multilayer composite polypropylene infusion membrane material.

[0010] Another objective of this invention is to provide a multi-chamber bag for infusion.

[0011] To achieve the above objectives, the present invention provides a multilayer composite polypropylene infusion membrane material, comprising an inner layer, a middle layer, and an outer layer. The inner layer is composed of ethylene-propylene-butyl terpolymer polypropylene and nano-zinc oxide in a mass ratio of 1:0.2-0.5. The middle layer is composed of propylene-butyl binary random copolymer polypropylene, ethylene-vinyl alcohol copolymer (EVOH), and styrene-based block copolymer (SEBS) in a mass ratio of 2-4:1:0.1-0.5. The outer layer is composed of homopolymer polypropylene (PP), polyethylene terephthalate (PET), and styrene-based block copolymer (SEBS) in a mass ratio of 2.5-3.5:2-2.5:1.

[0012] The composite polypropylene infusion membrane material of this invention has an inner layer composition in which the ethylene-propylene-butadiene terpolymer polypropylene has a melt index of 5.0–7.0 g / 10 min, preferably 5.5–6.4 g / 10 min, and a density of 0.89–0.94 g / cm³. 3The ethylene content is 2.5–3.0 wt%, and the butene content is 4.0–5.0 wt%. This layer mainly provides the membrane material with heat-sealing properties, antibacterial properties, and compatibility with the drug solution.

[0013] The composite polypropylene infusion membrane material of this invention comprises an intermediate layer with a melt index of 2.0–5.0 g / 10 min for the propylene-butadiene binary copolymer polypropylene, a butene content of 4.0–8.0 wt%, a melt index of 1.0–4.0 g / 10 min for the ethylene-vinyl alcohol copolymer EVOH, and a melt index of 3.0–6.0 g / 10 min for the styrene-based block copolymer SEBS. The main functions of this layer are to provide barrier properties, a balance of rigidity and toughness, transparency, and to connect the inner and outer layers of the infusion membrane bag.

[0014] The composite polypropylene infusion membrane material of this invention comprises an outer layer with a melt index of 2.0–5.0 g / 10 min for homopolymer polypropylene (PP), 3.0–5.0 g / 10 min for polyethylene terephthalate (PET), and 3.0–5.0 g / 10 min for styrene-based block copolymer (SEBS). The main function of this layer is to provide the infusion membrane bag with weather resistance, barrier properties, scratch resistance, transparency, and heat resistance during heat sealing.

[0015] The composite polypropylene infusion membrane material of the present invention has a total thickness of 160-240 μm, an inner layer thickness of 20-40 μm, a middle layer thickness of 120-160 μm, and an outer layer thickness of 20-40 μm.

[0016] The composite polypropylene infusion membrane material of the present invention comprises a styrene-ethylene-butadiene-styrene block copolymer.

[0017] To achieve the above objectives, this invention also provides a method for preparing the composite polypropylene infusion membrane material. The method involves separately blending the inner, middle, and outer layer granules and then placing them into the corresponding extruder hoppers of a multilayer co-extrusion blown film machine for co-extrusion blown film production. Compressed air is used for blown film production, followed by cooling, shaping, winding, and slitting of the resulting product. The multilayer co-extrusion blown film machine is a conventional device in the art, and this invention does not limit its use; those skilled in the art can select one according to actual conditions. The compressed air blown film technology, cooling, shaping, winding, and slitting operations are also conventional techniques in the art, and this invention does not specifically limit their use.

[0018] The preparation method of the composite polypropylene infusion membrane material of the present invention includes the following water ring cooling conditions: flow rate of 500-700 L / H and temperature of purified water of 15-30℃.

[0019] The method for preparing the composite polypropylene infusion membrane material of the present invention involves inflating the membrane bubble by filling it with Class 100 purified air during the downblown membrane bubble process.

[0020] To achieve the above objectives, the present invention also provides a multi-chamber bag for infusion, which is prepared using the composite polypropylene infusion membrane material described above.

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

[0022] Beneficial effects of this invention:

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

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

[0025] (3) The light transmittance of the composite infusion membrane material of the present invention remains almost unchanged after sterilization, which is comparable to that of imported infusion membrane materials.

[0026] (4) The multi-layer co-extrusion blowing and cooling process is adopted. The entire preparation process is simple to operate. The infusion membrane prepared by the above components and this preparation method is not prone to membrane breakage or uneven thickness during production. The prepared infusion membrane has excellent mechanical properties, which can meet the requirements of infusion membrane. It also has the advantages of high temperature resistance, good light transmittance and good barrier performance, and has a wide application prospect in the field of infusion membrane. Attached Figure Description

[0027] Figure 1 This is a schematic diagram of the structure of the composite polypropylene infusion membrane material of the present invention. Detailed Implementation

[0028] The present invention will now be described in detail through embodiments. It should be noted that the following embodiments are only for further illustration of the present invention and should not be construed as limiting the scope of protection of the present invention. Those skilled in the art can make some non-essential improvements and adjustments to the present invention based on the above description.

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

[0030] The ethylene-propylene-butadiene ternary copolymer polypropylene was Lotte Chemicals' SFC750D (melt index 6.4 g / 10 min), Borealis' TD109CF (melt index 6.0 g / 10 min), and LyondellBasell's 3C30FHP (melt index 5.5 g / 10 min).

[0031] Zinc oxide is a commercially available product;

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

[0033] The ethylene-vinyl alcohol copolymers EVOH were Kuraray H171B (melt index 1.7 g / 10 min), SP292B (melt index 2.0 g / 10 min), and F104B (melt index 4.5 g / 10 min) from Japan.

[0034] The styrene-ethylene-butadiene-styrene block copolymers SEBS are Kraton G1645 (melt index 3.0 g / 10 min), G1652 (melt index 2.0 g / 10 min), and G1643 (melt index 8.0 g / 10 min), respectively.

[0035] The polypropylene (PP) used were Lotte Chemicals' SFO130A (melt index 2.7 g / 10 min), Lanzhou Petrochemical's H02M (melt index 2.2 g / 10 min), and Ningbo Formosa Plastics' 1024 (melt index 1.8 g / 10 min);

[0036] The polyethylene terephthalate (PET) products are Eastman 9921 (melt index 15.0 g / 10 min) and F80CC (melt index 10.0 g / 10 min), respectively.

[0037] The melt flow index determination standard involved in this invention is GB / T 3682.1—2018, and the determination conditions are 230℃ / 2.16kg.

[0038] Example 1

[0039] The multilayer composite polypropylene infusion membrane material provided in this embodiment includes an inner layer, a middle layer, and an outer layer;

[0040] The inner layer is composed of ethylene-propylene-butyl terpolymer polypropylene SFC750D from Lotte Chemicals of South Korea, with a mass ratio of 1:0.2 to nano zinc oxide; the middle layer is composed of propylene-butyl binary random copolymer polypropylene PPR-FT03-S from Maoming Petrochemical, with a mass ratio of 2:1:0.2 to EVOH (H171B) and SEBS (G1645); the outer layer is composed of PP from Lotte Chemicals of South Korea SFO130A, with a mass fraction ratio of 3.5:2.4:1 to PET (9921) and SEBS (G1645); the thickness ratio of the inner, middle, and outer layers is 1:6:1; and the total thickness of the infusion membrane is 160 μm.

[0041] 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 film cooling process, the components of the inner layer, middle layer and outer layer are mixed evenly and added into the corresponding extruder hopper for co-extrusion blown film. Compressed air is used for blown film, and the thickness of different layers is adjusted by controlling the traction frequency of the die head. The film is then cooled by water ring, shaped, and wound into a cylindrical film, and then slit to obtain the infusion film. The process conditions for water ring cooling are: flow rate of 700 L / H, purified water temperature of 15℃, and Class 100 purified air filling the membrane bubble.

[0042] Example 2

[0043] The multilayer composite polypropylene infusion membrane material provided in this embodiment includes an inner layer, a middle layer, and an outer layer;

[0044] The inner layer is composed of ethylene-propylene-butyl terpolymer polypropylene TD109CF from Borealis, with a mass ratio of 1:0.5 to nano zinc oxide; the middle layer is composed of propylene-butyl binary random copolymer polypropylene F5005B from Yanshan Petrochemical, with a mass ratio of 3:1:0.5 to EVOH (SP292B) and SEBS (G1652); the outer layer is composed of PP H02M from Lanzhou Petrochemical, with a mass fraction ratio of 2.5:2.2:1 to PET (9921) and SEBS (G1652), and a melt index of 5.0 g / 10 min; the thickness ratio of the inner, middle, and outer layers is 1:4:1; the total thickness of the infusion membrane is 240 μm.

[0045] 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 film cooling process, the components of the inner layer, middle layer and outer layer are mixed evenly and added into the corresponding extruder hopper for co-extrusion blown film. Compressed air is used for blown film, and the thickness of different layers is adjusted by controlling the traction frequency of the die head. The film is then cooled by water ring, shaped, and wound into a cylindrical film, and then slit to obtain the infusion film. The process conditions for water ring cooling are: flow rate of 500 L / H, purified water temperature of 30℃, and Class 100 purified air filling the membrane bubble.

[0046] Example 3

[0047] The multilayer composite polypropylene infusion membrane material provided in this embodiment includes an inner layer, a middle layer, and an outer layer;

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

[0049] 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 film cooling process, the components of the inner layer, middle layer and outer layer are mixed evenly and added into the corresponding extruder hopper for co-extrusion blown film, using compressed air blown film, adjusting the thickness of different layers by controlling the traction frequency of the die head, and sequentially cooling, shaping and winding into a cylindrical film through a water ring, and then slitting to obtain the infusion film. The process conditions of the water ring cooling are: flow rate of 700L / H, purified water temperature of 25℃, and the membrane bubble is filled with Class 100 purified air.

[0050] Example 4

[0051] The multilayer composite polypropylene infusion membrane material provided in this embodiment includes an inner layer, a middle layer, and an outer layer;

[0052] The inner layer is composed of ethylene-propylene-butyl terpolymer polypropylene TD109CF from Borealis, with a mass ratio of 1:0.4 to nano zinc oxide; the middle layer is composed of propylene-butyl binary random copolymer polypropylene PPR-FT03-S from Maoming Petrochemical, with a mass ratio of 4:1:0.2 to EVOH (H171B) and SEBS (G1652); the outer layer is composed of PP from Lotte Chemicals (Korea), with a mass fraction ratio of 3.0:2.5:1 to PET (F80CC) and SEBS (G1652); the thickness ratio of the inner, middle, and outer layers is 1:6:2; and the total thickness of the infusion membrane is 180 μm.

[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 film cooling process, the components of the inner layer, middle layer and outer layer are mixed evenly and added into the corresponding extruder hopper for co-extrusion blown film. Compressed air is used for blown film, and the thickness of different layers is adjusted by controlling the traction frequency of the die head. The film is then cooled by water ring, shaped, and wound into a cylindrical film, and then slit to obtain the infusion film. The process conditions for water ring cooling are: flow rate of 600 L / H, purified water temperature of 25℃, and Class 100 purified air filled in the membrane bubble.

[0054] Example 5

[0055] The multilayer composite polypropylene infusion membrane material provided in this embodiment includes an inner layer, a middle layer, and an outer layer;

[0056] The inner layer is composed of ethylene-propylene-butyl terpolymer polypropylene, which is LyondellBasell 3C30FHP, with a mass ratio of 1:0.4 to nano zinc oxide; the middle layer is composed of propylene-butyl binary random copolymer polypropylene, which is Yanshan Petrochemical's F5005B, with a mass ratio of 3:1:0.1 to EVOH (H171B) and SEBS (G1643); the outer layer is composed of PP, which is Lanzhou Petrochemical's H02M, with a mass fraction ratio of 3.0:2.4:1 to PET (9921) and SEBS (G1643); the thickness ratio of the inner, middle, and outer layers is 3:15:4; and the total thickness of the infusion membrane 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 film cooling process, the components of the inner layer, middle layer and outer layer are mixed evenly and added into the corresponding extruder hopper for co-extrusion blown film, using compressed air blown film, adjusting the thickness of different layers by controlling the traction frequency of the die head, and sequentially cooling, shaping and winding into a cylindrical film through a water ring, and then slitting to obtain the infusion film. The process conditions of the water ring cooling are: flow rate of 600L / H, purified water temperature of 30℃, and the membrane bubble is filled with Class 100 purified air.

[0058] Comparative Example 1

[0059] Based on Example 1, the ethylene-propylene-butyl ternary copolymer polypropylene was replaced with ethylene-propylene binary copolymer polypropylene (Tianjin Petrochemical RP129K, melt index 5.0 g / 10 min), while other components and preparation methods remained unchanged.

[0060] Comparative Example 2

[0061] Based on Example 1, EVOH(H171B) was removed, while other components and preparation methods remained unchanged.

[0062] Comparative Example 3

[0063] Based on Example 1, polypropylene (PP) was replaced with ethylene-propylene-butyl terpolymer polypropylene (SFC750D from Lotte Chemicals, South Korea), while other components and preparation methods remained unchanged.

[0064] Comparative Example 4

[0065] Based on Example 1, the mass fraction ratio of the intermediate layer of propylene-butadiene binary random copolymer polypropylene, EVOH (H171B) and SEBS (G1645) was replaced from 2:1:0.2 to 1:1:0.2, while other components and preparation methods remained unchanged.

[0066] Comparative Example 5

[0067] Based on Example 1, the mass fraction ratio of PP, PET (9921) and SEBS (G1645) was changed from 3.5:2.4:1 to 5:1:1, while other components and preparation methods remained unchanged.

[0068] Test case

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

[0070] 1. Evaluation of barrier effect

[0071] Water vapor transmission rate: measured according to the water vapor transmission rate determination method YBB00092003—2015; nitrogen and oxygen transmission rates: measured according to the gas transmission rate determination method 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 moisture and gas barrier properties, which meet the requirements of infusion membrane materials, while the moisture and gas barrier properties of Comparative Examples 1-5 are all weaker than those of Examples 1-5.

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

[0076] Tensile strength was measured according to YBB00112003—2015, and heat-sealing strength was measured according to YBB00122003—2015. The results are shown in Table 2.

[0077] Table 2

[0078]

[0079] As can be seen from the table above, the longitudinal / transverse tensile strength of Examples 1 to 5 of the present invention is all >30MPa, the tensile strength is >20N / 15mm, and the weak weld strength is in the range of 8 to 15N / 15mm, which meets the requirements of infusion membrane materials. However, the longitudinal / transverse tensile strength, tensile strength, and weak weld strength of Comparative Examples 1 to 5 are not as good as those of the Examples.

[0080] 3. Dissolution test:

[0081] The following tests were conducted in accordance with the relevant test standards in YBB00102005-2015, and the results are shown in Table 3.

[0082] Table 3

[0083] Example 1 6.40 0.23 Compliant Example 2 6.45 0.25 Compliant Example 3 6.37 0.20 Compliant Example 4 6.40 0.22 Compliant Example 5 6.35 0.24 Compliant Comparative Example 1 6.60 0.45 Non-compliant Comparative Example 2 6.81 0.65 Non-compliant Comparative Example 3 6.77 0.50 Non-compliant Comparative Example 4 6.82 0.48 Non-compliant Comparative Example 5 6.90 0.52 Non-compliant

[0084] As can be seen from the table above, the pH value, oxidizable value, and absorbance of Examples 1 to 5 of the present invention all meet the requirements of infusion membrane materials, while the oxidizable value of Comparative Examples 1 to 5 is relatively high and the absorbance does not meet the requirements.

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

[0086] The results were determined according to the ultraviolet-visible spectrophotometry method (General Chapter 0401, Part IV, Chinese Pharmacopoeia 2015). The results are shown in Table 4.

[0087] Table 4

[0088]

[0089]

[0090] As can be seen from the table above, the light transmittance of Examples 1 to 5 of the present invention remained almost unchanged before and after sterilization, all remaining above 94%, while the light transmittance of Comparative Examples 1 to 5 was lower than that of the Examples before and after sterilization.

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

Claims

1. A multilayer composite polypropylene infusion membrane material, characterized in that, The product comprises an inner layer, a middle layer, and an outer layer. The inner layer consists of ethylene-propylene-butyl terpolymer polypropylene and nano zinc oxide in a mass ratio of 1:0.2~0.

5. The middle layer consists of propylene-butyl binary random copolymer polypropylene, ethylene-vinyl alcohol copolymer (EVOH), and styrene-based block copolymer in a mass ratio of 2~4:1:0.1~0.

5. The outer layer consists of homopolymer polypropylene (PP), polyethylene terephthalate (PET), and styrene-based block copolymer in a mass ratio of 2.5~3.5:2~2.5:

1.

2. The composite polypropylene infusion membrane material according to claim 1, characterized in that, The melt flow index of the ethylene-propylene-butadiene terpolymer polypropylene in the inner layer is 5.0~7.0 g / 10min, and the density is 0.89~0.94 g / cm³. 3 The ethylene content is 2.5~3.0 wt%, and the butene content is 4.0~5.0 wt%.

3. The composite polypropylene infusion membrane material according to claim 2, characterized in that, The melt index of the ethylene-propylene-butadiene terpolymer polypropylene in the inner layer is 5.5~6.4 g / 10min.

4. The composite polypropylene infusion membrane material according to claim 1, characterized in that, The melt index of the propylene-butadiene binary copolymer polypropylene is 3.0~6.0 g / 10 min, the butene content is 4.0~8.0 wt%, the melt index of the ethylene-vinyl alcohol copolymer EVOH is 1.0~4.5 g / 10 min, and the melt index of the styrene block copolymer is 2.0~20.0 g / 10 min.

5. The composite polypropylene infusion membrane material according to claim 1, characterized in that, The outer layer components have a melt index of 2.0~5.0 g / 10 min for homopolymer polypropylene (PP), a melt index of 10.0~15.0 g / 10 min for polyethylene terephthalate (PET), and a melt index of 2.0~20.0 g / 10 min for styrene-based block copolymers.

6. The composite polypropylene infusion membrane material according to claim 1, characterized in that, The total thickness of the multilayer composite polypropylene infusion membrane is 160~240μm, the inner layer thickness is 20~40μm, the middle layer thickness is 120~160μm, and the outer layer thickness is 20~40μm.

7. The composite polypropylene infusion membrane material according to claim 1, characterized in that, The styrene-based block copolymer is a styrene-ethylene-butadiene-styrene block copolymer.

8. The method for preparing the composite polypropylene infusion membrane material according to any one of claims 1 to 7, characterized in that, The inner, middle, and outer layer granules are blended separately and then fed into the corresponding extruder hoppers of a multi-layer co-extrusion blown film machine for co-extrusion blown film production. Compressed air is used for blown film production. The resulting products are then cooled by a water ring, shaped, wound, and slit.

9. The method for preparing the composite polypropylene infusion membrane material according to claim 8, characterized in that, The water ring cooling conditions are: flow rate of 500~700L / h, and temperature of purified water of 15~30℃.

10. The method for preparing the composite polypropylene infusion membrane material according to claim 8, characterized in that, The film is inflated using Class 100 purified air during the blowing process.

11. A multi-chamber bag for infusion, characterized in that, It is prepared using the composite polypropylene infusion membrane material according to any one of claims 1 to 7.

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