Method for preparing powder-liquid multi-chamber bag film material by co-extrusion blown film method

Abstract

The application discloses a method for preparing a powder-liquid multi-chamber bag film material by a co-extrusion film blowing method, and belongs to the technical field of medicine bag materials, and solves the problem of inner layer adhesion after sterilization in the prior art. The method comprises the following steps: after film material raw materials are extruded through a high-temperature extrusion die, the obtained film bubble is shaped through a herringbone plate, is pulled through three groups of traction rollers, and is wound up to obtain the powder-liquid multi-chamber infusion bag film material; and clean air is filled into the film body between the end of the second traction roller group and the front end of the third traction roller group. The application creatively fills a small amount of clean air into the film body between the end of the second traction roller group and the front end of the third traction roller group, thereby effectively preventing the problem of inner layer adhesion after sterilization. The powder-liquid multi-chamber infusion bag film material has good interlayer compatibility, excellent welding performance, good film forming property, high transparency, and no inner layer adhesion after sterilization, and has excellent bag opening effect after filling.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical packaging technology, specifically relating to a method for preparing powder-liquid multi-chamber bag film materials by co-extrusion blown film method. Background Technology

[0002] Multilayer co-extrusion composite blown film technology has seen significant development in recent years. Co-extruded composite films, with their unique and superior properties, are increasingly widely used in various fields such as food packaging, pharmaceuticals, chemicals, industry, and agriculture. Multi-compartment powder-liquid infusion bags are currently among the most advanced infusion products internationally. They contain liquid-liquid and powder-liquid formulations and can be manufactured in dual-compartment, triple-compartment, or other configurations. Each compartment contains the medication independently, and the medications are mixed only before use, effectively controlling the stability and efficacy of the drugs. Multi-compartment powder-liquid infusion bags offer significant advantages over traditional powder-based infusion products in terms of safety, practicality, economy, and environmental friendliness.

[0003] In existing technologies, multi-layer co-extrusion blown film technology is generally used to prepare powder-liquid multi-compartment infusion bags. The specific method involves placing the raw materials for each layer of the film material into the extruder hopper of the co-extrusion blown film machine, extruding through a high-temperature die, and then water-cooling or air-cooling. The resulting film bubble is then shaped by a herringbone plate, pulled by traction rollers, and wound up. Unlike general plastic products, powder-liquid multi-compartment infusion bags are typically sterilized under humid heat conditions with high temperature, humidity, and pressure before being filled with medication. This process often results in film adhesion, leading to a low opening rate when filling powder injections. Patent CN100430304C discloses a method for preparing a powder-liquid film, which solves the problem of inner layer adhesion during sterilization by setting striped protrusions on the inner side of the bag film. However, this method requires a special mold, resulting in high manufacturing costs, and the internal raised stripes cannot guarantee the uniformity of film thickness, making the process difficult to control.

[0004] Therefore, providing a method for preparing powder-liquid multi-chamber bag film by co-extrusion blown film method can effectively avoid inner layer adhesion after high temperature and humid heat sterilization, and has low cost and uniform film material, which has become an urgent problem to be solved by those skilled in the art. Summary of the Invention

[0005] The purpose of this invention is to provide a method for preparing powder-liquid multi-chamber bag film by co-extrusion blown film method, which solves the problem of inner layer adhesion after sterilization in the prior art.

[0006] To achieve the above objectives, the technical solution adopted by the present invention is as follows: The method for preparing multi-chamber bag film material for powder and liquid by co-extrusion blown film method provided by the present invention includes the following steps: the film material raw material is passed through a high-temperature extrusion die and then cooled by water. The resulting film bubble is shaped by a herringbone plate, pulled by three sets of traction rollers, and wound up to obtain the film material for multi-chamber infusion bag for powder and liquid; and clean air is filled into the film body between the end of the second traction roller group and the front end of the third traction roller group.

[0007] In some embodiments of the present invention, the amount of clean air injected into the membrane per meter of length is 500-5000 cm³, preferably 1000-4500 cm³. Preferably, the air cleanliness level is within 10,000.

[0008] In some embodiments of the present invention, the length of the film at the end of the second traction roller group and the beginning of the third traction roller group is 1-3m.

[0009] In some embodiments of the present invention, the length of the film at the end of the second traction roller group and the beginning of the third traction roller group is 1.5m.

[0010] In some embodiments of the present invention, the width of the film at the end of the second traction roller group and the beginning of the third traction roller group is 200-300 mm.

[0011] In some embodiments of the present invention, the width of the film at the end of the second traction roller group and the beginning of the third traction roller group is 240-250 mm.

[0012] In some embodiments of the present invention, the extrusion temperature is 170-220°C and the die temperature is 190-210°C.

[0013] In some embodiments of the present invention, the winding parameters are: the tension of the third traction roller is 3-8 KGF, the surface tension of the film roll is 1-5 KGF, the center tension of the film roll is 1-5 KGF, and the taper of the film roll is 50-80%. In some embodiments of the present invention, the winding parameters are as follows: the tension of the third traction roller is 3-5 KGF, the surface tension of the film roll is 1.5-3 KGF, the center tension of the film roll is 1.5-3 KGF, and the tension taper of the film roll is 50-70%.

[0014] In some embodiments of the present invention, the membrane material is a multilayer membrane material, preferably 1-5 layers, more preferably 1-3 layers, and most preferably 3 layers.

[0015] In some embodiments of the present invention, when the film material has three layers, the raw materials of each layer of film material are placed into the extruder hopper corresponding to the co-extrusion blown film machine and extruded through a high-temperature extrusion die; wherein the extrusion temperature of the inner layer of the film material is 180-220℃, the extrusion temperature of the middle layer is 170-200℃, and the extrusion temperature of the outer layer is 180-220℃.

[0016] In some embodiments of the present invention, the raw material of the inner membrane material includes the following components in parts by weight: 70-95 parts of polypropylene and 5-30 parts of elastomer A. The raw materials of the middle layer membrane material include the following components in parts by weight: 10-50 parts of copolymer polypropylene and 50-90 parts of elastomer B. The raw materials of the outer membrane material include the following components in parts by weight: 40-80 parts of homopolymer polypropylene, 10-30 parts of copolymer polypropylene, and 10-30 parts of elastomer C. In some embodiments of the present invention, the raw material of the inner membrane material includes the following components in parts by weight: 80-90 parts of polypropylene and 10-20 parts of elastomer A. The raw materials of the middle layer membrane material include the following components in parts by weight: 20-40 parts of copolymer polypropylene and 60-80 parts of elastomer B. The raw materials of the outer membrane material include the following components in parts by weight: 40-80 parts of homopolymer polypropylene, 10-30 parts of copolymer polypropylene, and 10-30 parts of elastomer C. In some embodiments of the present invention, the raw material of the middle layer includes 40 parts by weight of copolymer polypropylene and 60 parts by weight of elastomer B; The outer layer consists of 60 parts by mass of homopolymer polypropylene, 20 parts by mass of copolymer polypropylene, and 20 parts by mass of elastomer C.

[0017] In some embodiments of the present invention, elastomer A is a polyethylene-butene copolymer; Elastomer B and elastomer C are independently selected from one or more of styrene-ethylene-butene-styrene block copolymers, styrene-ethylene-propylene-styrene copolymers, and polyethylene-butene copolymers.

[0018] In some embodiments of the present invention, the raw materials of the middle layer are copolymer polypropylene, ethylene-ethylene-butene-styrene block copolymer and polyethylene-butene copolymer; wherein the copolymer polypropylene is 40 parts by mass, the ethylene-ethylene-butene-styrene block copolymer is 40 parts by mass, and the polyethylene-butene copolymer is 20 parts by mass.

[0019] In some embodiments of the present invention, the components of each layer of film material raw material are blended, extruded and granulated, and then the resulting raw material particles are placed into the extruder hopper corresponding to the co-extrusion blown film machine.

[0020] In some embodiments of the present invention, the thickness of the membrane material is calculated as 100%, and the thickness ratios of the inner layer, middle layer, and outer layer are 10-20%, 60-80%, and 10-20%, respectively.

[0021] The membrane material prepared by the method of this invention is cut, sealed and welded to obtain a powder-liquid multi-chamber infusion bag.

[0022] Compared with the prior art, the present invention has the following beneficial effects: This invention is scientifically designed and ingeniously conceived. It creatively prevents the problem of inner layer adhesion after sterilization by filling a small amount of clean air into the membrane body between the end of the second traction roller group and the front end of the third traction roller group.

[0023] The method of the present invention does not require special equipment, and each time air is injected into a whole sheet of film material, which is then pressed into individual bags, resulting in high efficiency and uniform and stable product quality.

[0024] The powder-liquid multi-chamber bag infusion membrane material of the present invention has good interlayer compatibility, excellent welding performance, good film-forming properties, high transparency, and the inner layer does not stick together after sterilization, resulting in excellent filling and bag opening effects. Attached Figure Description

[0025] Figure 1 This is a flowchart of the membrane material preparation process of the present invention. Detailed Implementation

[0026] The technical solution of the present invention will be further described in detail below with reference to specific embodiments. It should be understood that the following embodiments are merely illustrative and explanatory of the present invention, and should not be construed as limiting the scope of protection of the present invention. All technologies implemented based on the above content of the present invention are covered within the scope of protection intended by the present invention.

[0027] Unless otherwise stated, the raw materials and reagents used in the following examples are commercially available products or can be prepared by known methods.

[0028] The melt flow index in this embodiment of the invention is the melt flow index under the conditions of 230°C and 2.16Kg load.

[0029] Example 1 This embodiment discloses a method for preparing multi-chamber bag film materials using co-extrusion blown film method. The film material in this embodiment has three layers, and its specific preparation method is as follows, resulting in film material ①: S1. The components of the inner layer membrane material raw material are blended, extruded, and granulated to obtain an inner layer membrane material raw material mixture; the middle layer membrane material raw material mixture and the outer layer membrane material raw material mixture are prepared by the same method.

[0030] S2. The mixture of raw materials for each layer of film is placed into the extruder hopper of the three-layer co-extrusion blown film machine. After passing through the high-temperature extrusion die, the extrusion temperature of the inner layer of the film is 180-220℃, the extrusion temperature of the middle layer is 170-200℃, the extrusion temperature of the outer layer is 180-220℃, and the die temperature is 190-210℃.

[0031] S3. After the extruded membrane bubble is cooled by water and shaped by a herringbone plate, it is then pulled by three sets of traction rollers, and 3000cm³ / m of clean air is injected into the membrane body between the end of the second traction roller set and the front end of the third traction roller set; the membrane body between the end of the second traction roller set and the beginning of the third traction roller set has a length of 1.5m and a width of 240mm.

[0032] S4. The membrane material, filled with clean air, is passed through a web guiding device and then wound up. The tension of the third traction roller is controlled at 5 kGF, the surface tension of the membrane roll is 1.5 kGF, the center tension of the membrane roll is 1.5 kGF, and the tension taper of the membrane roll is 70%. The total thickness of the membrane material obtained in this embodiment is 200 μm, of which the inner layer thickness is 40 μm, the middle layer thickness is 130 μm, and the outer layer thickness is 30 μm.

[0033] In this embodiment, the inner membrane material is made of polypropylene and polyethylene-butene copolymer in a mass ratio of 85:15. The middle layer membrane material is made of copolymer polypropylene, styrene-ethylene-butene-styrene block copolymer, and polyethylene-butene copolymer in a mass ratio of 40:40:20. The outer membrane material is made of homopolymer polypropylene, copolymer polypropylene, and styrene-ethylene-butene-styrene block copolymer in a mass ratio of 60:20:20.

[0034] The melt index of the inner layer membrane material mixture is 6 g / 10 min, the melt index of the middle layer membrane material mixture is 3 g / 10 min, and the melt index of the outer layer membrane material mixture is 5 g / 10 min.

[0035] Example 2 This embodiment discloses a method for preparing multi-chamber bag film materials using co-extrusion blown film method. The film material in this embodiment has three layers, and its specific preparation method is as follows, resulting in film material ②: S1. The components of the inner layer membrane material raw material are blended, extruded, and granulated to obtain an inner layer membrane material raw material mixture; the middle layer membrane material raw material mixture and the outer layer membrane material raw material mixture are prepared by the same method.

[0036] S2. The mixture of raw materials for each layer of film is placed into the extruder hopper of the three-layer co-extrusion blown film machine. After passing through the high-temperature extrusion die, the extrusion temperature of the inner layer of the film is 180-220℃, the extrusion temperature of the middle layer is 170-200℃, the extrusion temperature of the outer layer is 180-220℃, and the die temperature is 190-210℃.

[0037] S3. After the extruded membrane bubble is cooled by water and shaped by a herringbone plate, it is then pulled by three sets of traction rollers, and 500cm³ / m of clean air is injected into the membrane body between the end of the second traction roller set and the front end of the third traction roller set; the membrane body between the end of the second traction roller set and the beginning of the third traction roller set has a length of 1.5m and a width of 240mm.

[0038] S4. The membrane material, filled with clean air, is passed through a web guiding device and then wound up. The tension of the third traction roller is controlled at 5 kGF, the surface tension of the membrane roll is 1.5 kGF, the center tension of the membrane roll is 1.5 kGF, and the tension taper of the membrane roll is 70%. The total thickness of the membrane material obtained in this embodiment is 200 μm, of which the inner layer thickness is 40 μm, the middle layer thickness is 130 μm, and the outer layer thickness is 30 μm.

[0039] The raw materials for each layer of the membrane in this embodiment are the same as those in Embodiment 1.

[0040] Example 3 This embodiment discloses a method for preparing multi-chamber bag film materials using co-extrusion blown film method. The film material in this embodiment has three layers, and its specific preparation method is as follows, resulting in film material ③: S1. The components of the inner layer membrane material raw material are blended, extruded, and granulated to obtain an inner layer membrane material raw material mixture; the middle layer membrane material raw material mixture and the outer layer membrane material raw material mixture are prepared by the same method.

[0041] S2. The mixture of raw materials for each layer of film is placed into the extruder hopper of the three-layer co-extrusion blown film machine. After passing through the high-temperature extrusion die, the extrusion temperature of the inner layer of the film is 180-220℃, the extrusion temperature of the middle layer is 170-200℃, the extrusion temperature of the outer layer is 180-220℃, and the die temperature is 190-210℃.

[0042] S3. After the extruded membrane bubble is cooled by water and shaped by a herringbone plate, it is then pulled by three sets of traction rollers, and 1000cm³ / m of clean air is injected into the membrane body between the end of the second traction roller set and the front end of the third traction roller set; the membrane body between the end of the second traction roller set and the beginning of the third traction roller set has a length of 1.5m and a width of 250mm.

[0043] S4. The membrane material, filled with clean air, is passed through a web guiding device and then wound up. The tension of the third traction roller is controlled at 5 kg, the surface tension of the membrane roll is 1.5 kgf, the center tension of the membrane roll is 1.5 kgf, and the tension taper of the membrane roll is 70%. The total thickness of the membrane material obtained in this embodiment is 200 μm, of which the inner layer thickness is 40 μm, the middle layer thickness is 130 μm, and the outer layer thickness is 30 μm.

[0044] The raw materials for each layer of the membrane in this embodiment are the same as those in Embodiment 1.

[0045] Example 4 This embodiment discloses a method for preparing multi-chamber bag film materials using co-extrusion blown film method. The film material in this embodiment has three layers, and its specific preparation method is as follows, resulting in film material ④: S1. The components of the inner layer membrane material raw material are blended, extruded, and granulated to obtain an inner layer membrane material raw material mixture; the middle layer membrane material raw material mixture and the outer layer membrane material raw material mixture are prepared by the same method.

[0046] S2. The mixture of raw materials for each layer of film is placed into the extruder hopper of the three-layer co-extrusion blown film machine. After passing through the high-temperature extrusion die, the extrusion temperature of the inner layer of the film is 180-220℃, the extrusion temperature of the middle layer is 170-200℃, the extrusion temperature of the outer layer is 180-220℃, and the die temperature is 190-210℃.

[0047] S3. After the extruded membrane bubble is cooled by water and shaped by a herringbone plate, it is then pulled by three sets of traction rollers, and 3000cm³ / m of clean air is injected into the membrane body between the end of the second traction roller group and the front end of the third traction roller group; the membrane body between the end of the second traction roller group and the beginning of the third traction roller group has a length of 1.5m and a width of 250mm.

[0048] S4. The membrane material, filled with clean air, is passed through a web guiding device and then wound up. The tension of the third traction roller is controlled at 10 kGF, the surface tension of the membrane roll is 3 kGF, the center tension of the membrane roll is 3 kGF, and the tension taper of the membrane roll is 50%. The total thickness of the membrane material obtained in this embodiment is 200 μm, of which the inner layer thickness is 40 μm, the middle layer thickness is 130 μm, and the outer layer thickness is 30 μm.

[0049] The raw materials for each layer of the membrane in this embodiment are the same as those in Embodiment 1.

[0050] Example 5 This embodiment discloses a method for preparing multi-chamber bag film materials using co-extrusion blown film method. The film material in this embodiment has three layers, and its specific preparation method is as follows, resulting in film material ⑤: S1. The components of the inner layer membrane material raw material are blended, extruded, and granulated to obtain an inner layer membrane material raw material mixture; the middle layer membrane material raw material mixture and the outer layer membrane material raw material mixture are prepared by the same method.

[0051] S2. The mixture of raw materials for each layer of film is placed into the extruder hopper of the three-layer co-extrusion blown film machine. After passing through the high-temperature extrusion die, the extrusion temperature of the inner layer of the film is 180-220℃, the extrusion temperature of the middle layer is 170-200℃, the extrusion temperature of the outer layer is 180-220℃, and the die temperature is 190-210℃.

[0052] S3. After the extruded membrane bubble is cooled by water and shaped by a herringbone plate, it is then pulled by three sets of traction rollers, and 3000cm³ / m of clean air is injected into the membrane body between the end of the second traction roller set and the front end of the third traction roller set; the membrane body between the end of the second traction roller set and the beginning of the third traction roller set has a length of 1.5m and a width of 240mm.

[0053] S4. The membrane material, filled with clean air, is passed through a web guiding device and then wound up. The tension of the third traction roller is controlled at 2 kGF, the surface tension of the membrane roll is 1 kGF, the center tension of the membrane roll is 1 kGF, and the tension taper of the membrane roll is 80%. The total thickness of the membrane material obtained in this embodiment is 200 μm, of which the inner layer thickness is 40 μm, the middle layer thickness is 130 μm, and the outer layer thickness is 30 μm.

[0054] The raw materials for each layer of the membrane in this embodiment are the same as those in Embodiment 1.

[0055] Example 6 This embodiment discloses a method for preparing multi-chamber bag film materials using co-extrusion blown film method. The film material in this embodiment has three layers, and its specific preparation method is as follows, resulting in film material ⑥: S1. The components of the inner layer membrane material raw material are blended, extruded, and granulated to obtain an inner layer membrane material raw material mixture; the middle layer membrane material raw material mixture and the outer layer membrane material raw material mixture are prepared by the same method.

[0056] S2. The mixture of raw materials for each layer of film is placed into the extruder hopper of the three-layer co-extrusion blown film machine. After passing through the high-temperature extrusion die, the extrusion temperature of the inner layer of the film is 180-220℃, the extrusion temperature of the middle layer is 170-200℃, the extrusion temperature of the outer layer is 180-220℃, and the die temperature is 190-210℃.

[0057] S3. After the extruded membrane bubble is cooled by water and shaped by a herringbone plate, it is then pulled by three sets of traction rollers, and 1500cm³ / m of clean air is injected into the membrane body between the end of the second traction roller group and the front end of the third traction roller group; the membrane body between the end of the second traction roller group and the beginning of the third traction roller group has a length of 1.5m and a width of 240mm.

[0058] S4. The membrane material, filled with clean air, is passed through a web guiding device and then wound up. The tension of the third traction roller is controlled at 5 kGF, the surface tension of the membrane roll is 1.5 kGF, the center tension of the membrane roll is 1.5 kGF, and the tension taper of the membrane roll is 70%. The total thickness of the membrane material obtained in this embodiment is 200 μm, of which the inner layer thickness is 40 μm, the middle layer thickness is 130 μm, and the outer layer thickness is 30 μm.

[0059] In this embodiment, the inner membrane material is made of polypropylene and polyethylene-butene copolymer in a mass ratio of 90:10. The middle layer membrane material is made of copolymer polypropylene, styrene-ethylene-butene-styrene block copolymer, and polyethylene-butene copolymer in a mass ratio of 40:40:20. The outer membrane material is made of homopolymer polypropylene, copolymer polypropylene, and styrene-ethylene-butene-styrene block copolymer in a mass ratio of 60:20:20.

[0060] The melt index of the inner layer membrane material mixture is 6.3 g / 10 min, the melt index of the middle layer membrane material mixture is 3 g / 10 min, and the melt index of the outer layer membrane material mixture is 5 g / 10 min.

[0061] Example 7 This embodiment discloses a method for preparing multi-chamber bag film materials using co-extrusion blown film method. The film material in this embodiment has three layers, and its specific preparation method is as follows, resulting in film material ⑦: S1. The components of the inner layer membrane material raw material are blended, extruded, and granulated to obtain an inner layer membrane material raw material mixture; the middle layer membrane material raw material mixture and the outer layer membrane material raw material mixture are prepared by the same method.

[0062] S2. The mixture of raw materials for each layer of film is placed into the extruder hopper of the three-layer co-extrusion blown film machine. After passing through the high-temperature extrusion die, the extrusion temperature of the inner layer of the film is 180-220℃, the extrusion temperature of the middle layer is 170-200℃, the extrusion temperature of the outer layer is 180-220℃, and the die temperature is 190-210℃.

[0063] S3. After the extruded membrane bubble is cooled by water and shaped by a herringbone plate, it is then pulled by three sets of traction rollers, and 4500cm³ / m of clean air is injected into the membrane body between the end of the second traction roller group and the front end of the third traction roller group; the membrane body between the end of the second traction roller group and the beginning of the third traction roller group has a length of 1.5m and a width of 250mm.

[0064] S4. The membrane material, filled with clean air, is passed through a web guiding device and then wound up. The tension of the third traction roller is controlled at 5 kGF, the surface tension of the membrane roll is 1.5 kGF, the center tension of the membrane roll is 1.5 kGF, and the tension taper of the membrane roll is 70%. The total thickness of the membrane material obtained in this embodiment is 200 μm, of which the inner layer thickness is 40 μm, the middle layer thickness is 130 μm, and the outer layer thickness is 30 μm.

[0065] In this embodiment, the inner membrane material is made of polypropylene and polyethylene-butene copolymer in a mass ratio of 80:20. The middle layer membrane material is made of copolymer polypropylene, styrene-ethylene-butene-styrene block copolymer, and polyethylene-butene copolymer in a mass ratio of 40:40:20. The outer membrane material is made of homopolymer polypropylene, copolymer polypropylene, and styrene-ethylene-butene-styrene block copolymer in a mass ratio of 60:20:20.

[0066] The melt index of the inner layer membrane material mixture is 5.6 g / 10 min, the melt index of the middle layer membrane material mixture is 3 g / 10 min, and the melt index of the outer layer membrane material mixture is 5 g / 10 min.

[0067] Test Example 1: Effect of Air Injection Location on Membrane Material Quality Comparative Example 1 Compared to Example 1, the location of air injection in this comparative example differs. In this example, clean air was injected into the membrane body between the end of the first traction roller group and the front end of the second traction roller group, while all other conditions remained the same. The results showed that injecting air at this location resulted in incomplete compression between the membrane materials, affecting thickness measurement during membrane quality inspection and leading to inaccurate test data.

[0068] Comparative Example 2 Compared to Example 1, the location of air injection in this comparative example differs. In this example, clean air is injected into the film at the end of the third traction roller group, while all other conditions remain the same. The squeezing action of the traction rollers can lead to excessive air within the entire film sheet, resulting in an uneven final product. This can cause the film roll to loosen during transportation, affecting its end-use.

[0069] As can be seen from the comparative examples, the present invention cleverly involves the point of air injection during the membrane preparation process, effectively controlling the amount of air injected, ensuring the excellent and stable quality of the final product, preventing incomplete extrusion of the membrane material which would affect the quality inspection of the membrane material, and also avoiding excessive air in the membrane material which would make the final product too loose and affect drug filling.

[0070] Experimental Example 2: Effect of Different Process Parameters on Membrane Material Properties The membrane materials prepared in Examples 1-7 were measured, and the results are shown in the table below: Table 1. Test results of membrane material properties in Examples 1-7

[0071] Note: Sterilization in Table 1 shall be performed in accordance with the "Guideline for Validation of Moist Heat Sterilization Process" (2008 edition, China Food and Drug Administration Drug Certification Management Center). Weak welding and solid welding shall be performed in accordance with the "Determination of Heat and Strength" (National Drug Packaging (Materials) Method Standard YBB00122003, China Food and Drug Administration).

[0072] As shown in Table 1, when the amount of air injected into the membrane between the end of the second traction roller group and the front end of the third traction roller group is too small, it will result in insufficient air filling in the membrane, and the opening rate of the membrane material during filling will decrease significantly after sterilization. For example, the air injection amount of membrane material ② is only 500 cm³ / m, and its opening rate is significantly lower than that of other membrane materials.

[0073] When the tension of the third traction roller is too high, for example, when the tension of the traction roller of the film material ④ is as high as 10KGF, it will also significantly affect the opening rate of the film material during drug filling, causing it to decrease significantly.

[0074] When the tension of the third traction roller is too low, for example, when the tension of the traction roller of the film material ⑤ is only 2KGF, it will result in poor winding uniformity, which will cause the film roll to become loose and affect the end use.

[0075] Therefore, the membrane materials ①, ③, ⑥ and ⑦ of the present invention all meet the pharmacopoeia standards in terms of longitudinal and transverse tensile strength, weak weld and solid weld light transmittance, and have a high opening rate, no sticking, high membrane material roll neatness, and tight film roll.

[0076] Finally, it should be noted that the above embodiments are merely preferred embodiments of the present invention used to illustrate the technical solutions of the present invention, and are not intended to limit the invention, nor are they intended to limit the patent scope of the present invention. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. These modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention. That is to say, any changes or refinements made to the main design concept and spirit of the present invention that are not of substantial significance, but whose technical problems are still consistent with the present invention, should be included within the protection scope of the present invention. In addition, the direct or indirect application of the technical solutions of the present invention to other related technical fields are similarly included within the patent protection scope of the present invention.

Claims

1. A method for preparing powder-liquid multi-chamber bag film materials by co-extrusion blown film method, characterized in that, Includes the following steps: The membrane material raw material is extruded through a high-temperature die and then cooled by water. The resulting membrane bubble is shaped by a herringbone plate, pulled by three sets of traction rollers, and wound up to obtain the powder-liquid multi-chamber bag membrane material. Clean air is then filled into the membrane body between the end of the second traction roller set and the front end of the third traction roller set. The winding parameters are as follows: tension of the third traction roller group is 3-8 KGF, surface tension of the film roll is 1-5 KGF, center tension of the film roll is 1-5 KGF, and tension taper of the film roll is 50-80%. When the film material has 3 layers, the raw materials of each layer of film material are placed into the extruder hopper of the co-extrusion blown film machine and extruded through the high temperature extrusion die; wherein the extrusion temperature of the inner layer film material is 180-220℃, the extrusion temperature of the middle layer film material is 170-200℃, and the extrusion temperature of the outer layer film material is 180-220℃. The raw materials of the inner membrane material include the following components in parts by weight: 70-95 parts of polypropylene and 5-30 parts of elastomer A; The raw materials of the middle layer membrane material include the following components in parts by weight: 10-50 parts of copolymer polypropylene and 50-90 parts of elastomer B; The raw materials of the outer membrane material include the following components in parts by weight: 40-80 parts of homopolymer polypropylene, 10-30 parts of copolymer polypropylene, and 10-30 parts of elastomer C. Elastomer A is a polyethylene-butene copolymer; Elastomer B and elastomer C are independently selected from one or more of styrene-ethylene-butene-styrene block copolymers, styrene-ethylene-propylene-styrene copolymers, and polyethylene-butene copolymers; The thickness of the membrane material is calculated as 100%, and the thickness ratios of the inner membrane material, middle membrane material, and outer membrane material are 10-20%, 60-80%, and 10-20%, respectively.

2. The method according to claim 1, characterized in that, The clean air injection volume per meter of membrane length is 500-5000 cm³.

3. The method according to claim 2, characterized in that, The clean air injection volume per meter of membrane length is 1000-4500 cm³.

4. The method according to claim 1, characterized in that, The length of the membrane at the end of the second traction roller group and the beginning of the third traction roller group is 1-3m.

5. The method according to claim 4, characterized in that, The length of the membrane at the end of the second traction roller group and the beginning of the third traction roller group is 1.5m.

6. The method according to claim 1, characterized in that, The width of the film at the end of the second traction roller group and the beginning of the third traction roller group is 200-300mm.

7. The method according to claim 6, characterized in that, The width of the film at the end of the second traction roller group and the beginning of the third traction roller group is 240-250mm.

8. The method according to claim 1, characterized in that, The die head temperature is 190-210℃.

9. The method according to claim 1, characterized in that, The tension of the third traction roller group is 3-5 KGF, the surface tension of the film roll is 1.5-3 KGF, the center tension of the film roll is 1.5-3 KGF, and the tension taper of the film roll is 50-70%.

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