JP4492290B2 - Co-extruded film having pinhole resistance and barrier laminated laminate bag using the same - Google Patents

Description

  The present invention relates to a laminated transparent packaging material having a gas barrier property, a coextrusion film having a pinhole resistance used as a heat-sealing film, and a barrier laminate which is used when packaging and transporting an object having a thickness and weight. It relates to exterior bags.

  INDUSTRIAL APPLICABILITY The present invention can be used as a packaging material whose quality is easily deteriorated by the ingress of oxygen in the fields of medicine, pharmaceuticals, foods, and the like. It is useful as a heat-sealing film for an outer bag of an infusion bag formed by filling a container.

  Infusion bags filled with relatively large volumes of liquids have recently been filled into flexible plastic primary containers from the standpoints of ease of handling (handling), weight reduction of infusion bags, volume reduction of garbage, etc. Things are increasing (see Patent Document 1).

  Drugs such as amino acid solution and sugar / electrolyte solution filled in the infusion bag are remarkably easily altered by oxygen, and since the drug is directly injected into the body, the primary container is an additive-free plastic container (see Fig. 2). ) Is often used, and there is almost no oxygen barrier property. Therefore, if the infusion bag is left in the atmosphere, there is a problem that oxygen in the air permeates the infusion bag and changes the drug over time. Therefore, in recent years, secondary packaging of an infusion bag with a packaging material having a high oxygen barrier property has been performed.

  Since the outer packaging bag for secondary packaging of the infusion bag of the primary container is required to have a high oxygen barrier property as described above, a plastic film coated with PVDC (polyvinylidene chloride) or EVOH (ethylene -Vinyl alcohol copolymer) film, PVA (polyvinyl alcohol) film, PET (polyester terephthalate) film deposited with aluminum oxide or silicon oxide, stretched nylon film deposited with aluminum oxide or silicon oxide, EVOH layer, MXD6 Laminated packaging materials using a barrier nylon having a nylon layer as an intermediate layer are widely used.

  Usually, an infusion bag of a primary container filled with a high-calorie infusion consisting of amino acids, sugars, and electrolytes is placed in the outer bag, and further packed and transported in cardboard. Due to vibration during the transportation process, pinholes may be formed in the infusion outer packaging bag, which causes a problem that the oxygen barrier property cannot be maintained.

  Pinholes often occur due to three factors. Pinholes caused by bending fatigue of packaging materials, wear pinholes caused by wear of packaging materials, and piercing pinholes caused by projections of packaging materials being pierced In pinholes in the transportation process, a complex factor of bent pinholes and wear pinholes is a major cause.

  Patent Literature 2 and Patent Literature 3 describe packaging materials for exterior bags that contain an infusion bag and do not easily generate pinholes. We are studying the reduction of pinholes by countermeasures as the configuration of the laminated film, the packaging form, or the heat sealing method, which is different from the one defined by the density of the multilayer heat-sealing film as in the present invention.

The known literature is described below.
JP 10-314272 A Japanese Patent Laid-Open No. 9-262943 Japanese Patent No. 3202541

  The present invention was made in order to solve the problems of the prior art, and has a pinhole resistance that suppresses the generation of pinholes during the transportation process in the heat-sealing film of the gas barrier laminated outer bag. An object of the present invention is to provide a heat-sealing film and a gas barrier laminate outer bag using the same.

The invention according to claim 1 of the present invention is a gas-barrier laminated heat-sealing film used for an outer bag of a gas-barrier laminated package for packaging a primary container filled with an amino acid solution or a high-calorie infusion solution consisting of a sugar and an electrolyte solution. When the heat-sealing film is a three-layer laminated film and A / B / C from the side in contact with the contents, the thickness of each layer is A ≦ C ≦ B, and the density of each layer There a> Ri C ≧ B der, wherein a has a 0.930 g / cm ³ or more density, the B
Has a density of 0.915 g / cm ³ or less, wherein C is a coextruded film having a pinhole resistance, which is a less than 0.915 g / cm ³ or more 0.930 g / cm ^3.

In laminated packaging materials filled with oxidizing contents of about 500 ml to 2000 ml, such as outer bags for infusion bags, pinhole complaints in the order of ppm occur in the normal transportation process, the cause of which is due to bending The pinhole is caused by rubbing between the primary container and particularly the plastic port portion that pierces the catheter. In order to reduce the bent pinhole, in the present invention, the stiffness of the film (stiffness) is reduced. ) Must be softened, and the thickness of the B layer having the lowest density is made the thickest. Furthermore, in order to reduce pinholes due to rubbing (due to wear), the density of the innermost A layer is increased to improve slipping and abrasion resistance, and the thickness is decreased to keep the waist soft. Yes. However, when the layer having the lowest density is present on the surface layer, the slipperiness is deteriorated due to the stickiness of the film due to the low density, and wrinkles are generated during film formation, which is an obstacle to stable production. In view of this, a wrinkle-free layer such as a C layer having a density of 0.915 to 0.930 g / cm ³ is provided.

  When the thickness is 70 μm or more, the waist becomes stiffer than less than 70 μm, and therefore stable production is possible even in a two-layer configuration of the A layer and the B layer without using the C layer.

The invention according to claim 2 of the present invention, among the three-layer laminate film (A / B / C), claim 1, characterized in that it has a more than at least one layer, film layer, which is polymerized by a metallocene catalyst It is a coextruded film having pinhole resistance described.

  Rather than polymerizing with a Ziegler-Natta catalyst, a film polymerized with a metallocene catalyst has a narrow molecular weight distribution range and a uniform number of branches, so that a transparent and strong film can be obtained. Therefore, a film polymerized with a metallocene catalyst in at least one layer is used.

The invention according to claim 3 of the present invention is a coextrusion having pinhole resistance according to any one of claims 1 and 2, wherein the outer bag is a barrier laminate using a gas barrier laminate and a heat fusion film. It is an exterior bag of a barrier laminate , which is formed using a film .

The invention according to claim 4 of the present invention uses, as a primary container, an infusion bag made of an additive-free permeable plastic film filled and packaged with an infusion solution composed of an amino acid solution or a high calorie infusion solution consisting of a sugar and an electrolyte solution. 4. The barrier laminated laminate bag according to claim 3, wherein the primary container is secondarily packaged .

  By using the coextrusion film having pinhole resistance of the present invention for the gas barrier laminate outer bag, it is prevented that pinholes are generated in the infusion outer bag due to vibration during the transportation process, etc. Can be maintained.

According to the present invention, in order to reduce bent pinholes, it is necessary to soften the stiffness of the film, where the thickness of the B layer having the smallest density is maximized to reduce wear pinholes. In addition, the density of the innermost layer A is increased to improve slipperiness and abrasion resistance, and the thickness is made the thinnest to keep the waist soft, and the density of the layer C is 0.915 to 0.930 g / A wrinkle-free layer such as cm ³ is provided, wrinkles are not generated during film formation, stable production can be achieved, and the coextruded film having pinhole resistance of the present invention can be provided.

  The co-extruded film having pinhole resistance of the present invention has oxygen gas barrier properties, and if the gas barrier laminate of the outer bag of the infusion bag is used for the heat-sealing film portion, the contents are not oxidized and deteriorated. Can be stored.

  The best mode for carrying out the present invention will be specifically described below. FIG. 1 is a cross-sectional view of a coextruded film 50 having pinhole resistance according to the present invention. Its configuration is A / B / C from the side in contact with the contents. A is a medium-density layer 3, B is an ultra-low-density layer 2, and C is a co-extruded film 50 including the low-density layer 1. For reference, the gas barrier film 20 is displayed on the left side of the figure, and the gas barrier film 20 and the co-extruded film 50 are laminated to form the gas barrier laminated transparent packaging material 10 of the present invention. In the present invention, a co-extruded film 50 is used as the heat fusion film.

The medium density layer of A is not particularly limited as long as the resin has a density of 0.93 g / cm ³ or more, and is used for one layer of the coextruded film, and the thickness is desirably 10 μm to 20 μm. Considering that it is for medical and medical use and is in contact with the contents, it is desirable to use as few antioxidants, slip agents and antiblocking agents as possible. The ultra-low density layer of B has a density of 0.915 g / cm ³ or less, and the thickness is desirably about 30 μm. Furthermore, the ultra-low density layer of B is preferably a layer polymerized by a metallocene catalyst in order to become the layer that occupies the largest proportion of the coextruded film. The low density layer of C may be anything as long as it is a resin composed of 0.915 to 0.930 g / cm ^3, and an easy adhesion treatment such as a corona treatment is necessary in consideration of dry lamination.

FIG. 2 is a side view of the primary container 40 filled with the contents. The content 30 is an infusion composed of amino acids, sugars, and electrolytes of substances that deteriorate due to oxidation , the primary container is an infusion bag composed of an additive-free permeable plastic film, and the primary container is a gas barrier property of the present invention. This is a case of secondary packaging using a laminated outer bag. The primary container 40 of FIG. 2 is secondarily packaged using the gas barrier laminated transparent packaging material of the present invention (not shown in the figure).

FIG. 3 is a side sectional view of an example infusion outer packaging bag using the gas barrier laminated transparent packaging material 10 of the barrier outer packaging bag of the present invention. It is a barrier outer packaging bag that uses a co-extruded film 25 having pinhole resistance as a part of a content composed of a substance that deteriorates due to oxidation . The gas-permeable laminated transparent packaging material 10 has a layer structure of a printing substrate layer 21 / extruded polyethylene 22 / oxygen barrier layer 23 / adhesive layer 24 / and a co-extruded film layer 25 having pinhole resistance from the outside. It is an infusion outer packaging bag in which the content 30 is filled inside the coextruded film layer 25.

  Examples of the present invention will be described below. In all the configurations of the gas-barrier laminated transparent packaging material 10 in the examples, the gas-barrier laminated transparent packaging material 10 is composed of the gas-barrier laminated film 20 and the coextruded film 50, and the gas-barrier laminated films 20 are all the same configuration. Only the coextruded film 50 having pinhole resistance of the present invention was changed. FIG. 4 shows the configuration of the gas barrier laminated transparent packaging material 10 with the gas barrier laminated film and the coextruded film.

  All the gas-barrier laminated transparent packaging materials 10 in the example of FIG. 4 have a biaxially oriented polypropylene layer 20 μm thick (OPP, Tosero Co., U1) 21a / anchor coat layer 1 μm (Mitsui Takeda Chemical Co., Ltd., A -3210, A-3075, solid content 5%) 21b / extruded low density polyethylene 20μ (EX-LDPE, Nippon Polyethylene Co., Ltd., LC605Y) 22a / alumina-deposited biaxially stretched nylon (GL-AEYBC, Toppan Printing Co., Ltd.) , 15μ) 23a / adhesive layer 3μ (Mitsui Takeda Chemical Co., Ltd., A-525, A-52) 24a / gas barrier laminated gas barrier film 20 and coextruded film layer (C / B / A) A coextruded film 25a made of

The co-extruded film layer 25a used in Example 1 is (C / B / A), A is a density of 0.935 g / cm ³ and a thickness of 15 μm (Dow Chemical Co., Ltd. “Elite” 2036P). , Density 0.900 g / cm ³ , thickness 30 μm (Dow Chemical Co., Ltd. “Affinity” PF1140, PL1880 blend), C is density 0.920 g / cm ³ , thickness 15 μm (Dow Chemical Co., Ltd.) "Elite" 2045G) and laminated with the coextruded film layer of the present invention and the gas barrier laminate described above to produce an infusion outer bag of Example 1.

The coextruded film layer 25a used in Example 2 is (B / A), A is a density of 0.937 g / cm ³ and a thickness of 20 μm (Ube Industries, Ltd. “Umerit” 4040F), and B is a density of 0 904 g / cm ³ , 60 μm thick (Ube Industries, Ltd. “Umerit” 0540F) and laminated with the coextruded film layer of the present invention and the gas barrier laminate described above to produce an infusion outer packaging bag of Example 2 did.

  Examples 3 to 5 will be described below as comparative examples of the present invention.

The coextruded film layer 25a used in Example 3 is (B / A), A is a density of 0.931 g / cm ³ , a thickness of 20 μm (Ube Industries, Ltd. “Umerit” 3540F), and B is a density of 0 904 g / cm ³ and a thickness of 40 μm (Ube Industries, Ltd. “Umerit” 0540F) were laminated with the coextruded film layer and the gas barrier laminate described above to produce an infusion outer packaging bag of Example 3.

The coextruded film layer 25a used in Example 4 is (B / A), A is a density of 0.931 g / cm ³ and a thickness of 10 μm (Ube Industries, Ltd. “Umerit” 3540F), and B is a density of 0 904 g / cm ³ and a thickness of 50 μm (Ube Industries “Umerit” 0540F) were laminated with the coextruded film layer and the gas barrier laminate described above to produce an infusion outer packaging bag of Example 4.

The coextruded film layer 25a used in Example 5 is (C / B / A), and A is a density of 0.940 g / cm ³ and a thickness of 18 μm (a blend of Mitsui Chemicals, Inc. “Evolue” SP4030, SP4530). , B has a density of 0.915 g / cm ³ and a thickness of 30 μm (Mitsui Chemicals Co., Ltd. “Evolue” SP1540, SP2040 blend), and C has a density of 0.903 g / cm ↑ 3 and a thickness of 12 μm (Mitsui Chemicals ( Co., Ltd. “Evolue” SP0540) and laminated with the coextruded film layer and the gas barrier laminate described above to produce an infusion outer bag of Example 5.

  All the infusion outer packaging bags of Examples 1 to 5 were filled with the same contents, and vibration tests were performed in Examples 1 and 2 and Comparative Examples (Examples 3 to 5).

  Test 1 is a vibration test. The vibration conditions were ± 4 G (16.4 mm amplitude, 11 Hz), total 60 minutes (vertical direction 30 minutes + vertical 15 minutes + horizontal 15 minutes). The evaluation method is to create a bag of 285 mm x 315 mm, fill it with Otsuka Aminotripa No. 2, load and pack it in the same way as the current product, perform a vibration test under the above conditions, and pin with an osmotic solution I counted the number of holes. The results are shown in Table 1.

なお、ピンホール袋数は、ピンホール袋数／検査総袋数により表示した。

The number of pinhole bags was indicated by the number of pinhole bags / total number of inspection bags.

  From the above results, it can be seen that Examples 1 and 2 have reduced pinholes in the vibration test compared to Comparative Examples (Examples 3, 4 and 5). The above vibration test gives a significant difference in the results, so it is an over-evaluation test, the pinhole generation rate in the actual transportation process is on the order of ppm, and if it is a vibration test method according to JIS standards, the number of pinholes is all The configuration is zero.

It is a sectional side view of the co-extrusion film which has pinhole resistance of this invention. It is a sectional side view of the filled infusion primary container which is the contents. It is a sectional side view of an example infusion outer packaging bag using the barrier outer packaging bag of the present invention. It is a sectional side view of the infusion exterior bag of the Example of this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 ... Low density layer 2 ... Super low density layer 3 ... Medium density layer 10 ... Gas barrier property laminated transparent packaging material 11 ... Easy open seal 12 ... Plastic port part 20 ... Gas barrier film 21 ... Printing base material layer 21a ... Biaxial stretching Polypropylene layer 21b ... Anchor coat layer 22 ... Extruded polyethylene layer 22a ... Extruded low density polyethylene 23 ... Oxygen barrier layer 23a ... Alumina-deposited biaxially stretched nylon 24 ... Adhesive layer 24a ... Adhesive layer 25 ... Co-extruded film layer 25a ... Extruded film 30 ... Contents 40 ... (additive-free plastic) primary container 50 ... Co-extruded film (heat fusion film)

Claims (4)

A gas barrier laminated heat-sealing film for use in a gas barrier laminated outer bag for packaging a primary container filled with a high-calorie infusion solution consisting of an amino acid solution or a sugar and an electrolyte solution, wherein three layers of heat-sealing films are laminated made from the film, when the a / B / C from the side in contact with the contents, the thickness of each layer is a ≦ C ≦ B, and Ri density a> C ≧ B der of each layer, the a has a 0.930 g / cm ³ or more density, the B has a density of 0.915 g / cm ³ or less, wherein C is less than 0.915 g / cm ³ or more 0.930 g / cm ³ A co-extruded film having pinhole resistance. The co-extrusion film having pinhole resistance according to claim 1, wherein a film layer polymerized by a metallocene catalyst is provided in at least one layer of the three-layer laminated film (A / B / C). . An outer bag of a barrier laminate using a gas barrier laminate and a heat-sealing film, wherein the bag is made using the coextrusion film having pinhole resistance according to any one of claims 1 and 2. Barrier laminated outer bag. A primary container is an infusion bag made of an additive-free permeable plastic film filled and packaged with an infusion solution composed of an amino acid solution or a high-calorie infusion solution consisting of a sugar and an electrolyte solution. 4. The barrier laminate outer bag according to claim 3 .

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