WO2012008007A1 - Film médical stratifié - Google Patents

Film médical stratifié Download PDF

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Publication number
WO2012008007A1
WO2012008007A1 PCT/JP2010/061783 JP2010061783W WO2012008007A1 WO 2012008007 A1 WO2012008007 A1 WO 2012008007A1 JP 2010061783 W JP2010061783 W JP 2010061783W WO 2012008007 A1 WO2012008007 A1 WO 2012008007A1
Authority
WO
WIPO (PCT)
Prior art keywords
layer
laminated film
medical
resin
film according
Prior art date
Application number
PCT/JP2010/061783
Other languages
English (en)
Japanese (ja)
Inventor
金山和史
栗山正秋
Original Assignee
四国化工株式会社
バクスター株式会社
バクスター・インターナショナル・インコーポレイテッド
バクスター・ヘルスケア・ソシエテ・アノニム
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 四国化工株式会社, バクスター株式会社, バクスター・インターナショナル・インコーポレイテッド, バクスター・ヘルスケア・ソシエテ・アノニム filed Critical 四国化工株式会社
Priority to PCT/JP2010/061783 priority Critical patent/WO2012008007A1/fr
Priority to JP2011510205A priority patent/JP5278543B2/ja
Priority to SG2011016789A priority patent/SG177232A1/en
Publication of WO2012008007A1 publication Critical patent/WO2012008007A1/fr

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/06—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • B32B27/08—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/30—Layered products comprising a layer of synthetic resin comprising vinyl (co)polymers; comprising acrylic (co)polymers
    • B32B27/306—Layered products comprising a layer of synthetic resin comprising vinyl (co)polymers; comprising acrylic (co)polymers comprising vinyl acetate or vinyl alcohol (co)polymers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/32—Layered products comprising a layer of synthetic resin comprising polyolefins
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/34—Layered products comprising a layer of synthetic resin comprising polyamides
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/36—Layered products comprising a layer of synthetic resin comprising polyesters
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B7/00—Layered products characterised by the relation between layers; Layered products characterised by the relative orientation of features between layers, or by the relative values of a measurable parameter between layers, i.e. products comprising layers having different physical, chemical or physicochemical properties; Layered products characterised by the interconnection of layers
    • B32B7/04—Interconnection of layers
    • B32B7/12—Interconnection of layers using interposed adhesives or interposed materials with bonding properties
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2250/00—Layers arrangement
    • B32B2250/05—5 or more layers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2250/00—Layers arrangement
    • B32B2250/24—All layers being polymeric
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/50—Properties of the layers or laminate having particular mechanical properties
    • B32B2307/51—Elastic
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/50—Properties of the layers or laminate having particular mechanical properties
    • B32B2307/514—Oriented
    • B32B2307/518—Oriented bi-axially
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/50—Properties of the layers or laminate having particular mechanical properties
    • B32B2307/546—Flexural strength; Flexion stiffness

Definitions

  • the present invention relates to a medical laminated film, and more particularly to a medical laminated film suitable as a drug solution for peritoneal dialysis, a back film for drainage, a film for infusion bags, and the like.
  • a medical liquid storage bag including at least five layers of a layer and a polyolefin layer is known (Patent Document 1).
  • films that use engineering plastics such as polyester resins and polyamide resins for the intermediate layer in addition to the outermost layer of the laminated film, such as the above-mentioned medical liquid storage bags have problems with physical strength such as tensile strength.
  • the present invention has been made in view of the above circumstances, and its purpose is to compare engineering plastics such as polyester resins and polyamide resins with a film that is also used for an intermediate layer in addition to the outermost layer of a laminated film.
  • An object of the present invention is to provide a medical laminated film that is not inferior in terms of physical strength such as tensile strength but is excellent in flexibility after high-pressure steam sterilization.
  • the gist of the present invention is formed by sequentially laminating at least A layer / B layer / C layer / D layer / E layer,
  • a layer is a polyester resin or polyamide resin
  • B layer is an adhesive resin
  • C layer I is a polyolefin-based resin layer
  • layer D is a polyolefin-based thermoplastic elastomer having a flexural modulus of 300 (MPa) or less
  • layer E is a polyolefin-based thermoplastic elastomer having a flexural modulus of 600-1500 (MPa).
  • the medical layered film is characterized in that the layer is disposed in the outermost layer and the E layer is disposed in the innermost layer.
  • a medical laminated film excellent in both physical strength such as tensile strength and flexibility is provided.
  • the medical laminated film of the present invention is formed by sequentially laminating at least the following A layer / B layer / C layer / D layer / E layer.
  • ⁇ A layer is made of polyester resin or polyamide resin.
  • polyester resin for example, polybutylene terephthalate (PBT) homopolymer and copolymer are preferably used.
  • polyamide resin for example, polyamide 6 or a copolymer of polyamide 6 and polyamide 66 is preferably used.
  • polyester resins or polyamide resins known polymers (resins) commonly used in the field of packaging films can be used.
  • copolymer component of the copolymer include the following components.
  • examples of the dicarboxylic acid include isophthalic acid, phthalic acid, 2,6-naphthalenedicarboxylic acid, adipic acid, sebacic acid, oxycarboxylic acid (for example, P-oxybenzoic acid), and the like.
  • examples thereof include ethylene glycol, diethylene glycol, propylene glycol, 1,4-cyclohexanedimethanol, neopentyl glycol, polyethylene oxide glycol, polypropylene oxide glycol, polytetramethylene oxide glycol and the like. Two or more of these dicarboxylic acid components and glycol components may be used in combination.
  • the proportion of PBT units derived from terephthalic acid and butylene glycol is usually 70 to 99 mol%, preferably 85 to 99 mol%, and the remainder is units derived from the above copolymerization components.
  • B layer is composed of adhesive resin.
  • a modified polyolefin resin is preferably used as the adhesive resin.
  • the modified polyolefin resin is produced by copolymerizing and / or graft-polymerizing an ⁇ , ⁇ -unsaturated carboxylic acid or a derivative thereof to a polyolefin resin mainly composed of an ethylene component and / or a propylene component.
  • polystyrene resin examples include polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-butene-1 copolymer, ethylene-vinyl acetate copolymer, ethylene-acrylic acid copolymer, and ethylene-ethylacrylic acid.
  • examples thereof include a copolymer and an ethylene-sodium acrylate copolymer.
  • Examples of the ⁇ , ⁇ -unsaturated carboxylic acid or derivative thereof to be copolymerized include acrylic acid, methacrylic acid, methyl methacrylic acid, sodium acrylate, zinc acrylate, vinyl acetate, glycidyl methacrylate, and the like. It is contained in the range within 40 mol%.
  • Examples of the copolymer-modified polyolefin resin include ethylene-vinyl acetate copolymer, ethylene-acrylic acid copolymer, ethylene-ethyl acrylic acid copolymer, ethylene-sodium acrylate copolymer, and the like.
  • ⁇ , ⁇ -unsaturated carboxylic acid or derivative thereof to be grafted examples include acrylic acid, methacrylic acid, ethacrylic acid, maleic acid, fumaric acid or acid anhydrides thereof, or esters of these acids. Is mentioned. Of these modifying compounds, maleic anhydride is particularly preferred.
  • the graft amount is selected from the range of 0.01 to 25% by weight, preferably 0.05 to 1.5% by weight, based on the polyolefin resin.
  • the grafting reaction is usually performed by melt-mixing a polyolefin resin and an ⁇ , ⁇ -unsaturated carboxylic acid or derivative thereof at a resin temperature of 150 to 300 ° C. according to a conventional method.
  • a resin temperature 150 to 300 ° C.
  • 0.001 to 0.05% by weight of an organic peroxide such as ⁇ , ⁇ '-bis-t-butylperoxy-p-diisopropylbenzene is blended in order to carry out the reaction efficiently. Is good.
  • C layer is composed of polyolefin resin layer.
  • polyolefin resin for example, propylene random copolymer resin (R-PP), metallocene polypropylene resin (M-PP), and metallocene low density polyethylene resin (M-PE) are preferably used.
  • the above propylene random copolymer resin (R-PP) is a random copolymer of propylene and a small amount of ⁇ -olefin.
  • the ⁇ -olefin is an ⁇ -olefin having 2 to 8 carbon atoms excluding propylene, and specific examples thereof include ethylene, 1-butene, 3-methyl 1-butene, 3-methyl-1- Examples include pentene, 4-methyl-1-pentene, and 1-octene. Of these, ethylene is preferred.
  • the copolymerization amount of the ⁇ -olefin is usually 0.1 to 5% by weight, preferably 1.5 to 4% by weight. Examples of commercially available products of R-PP include “NOVATEC PP” (trade name) manufactured by Nippon Polypro Co., Ltd.
  • M-PP metallocene polypropylene resin
  • M-PP is a polypropylene resin obtained using a metallocene catalyst, and its MI is usually 0.1 to 20 g / min (230 ° C.).
  • examples of commercially available products of M-PP include “Wintech” (trade name) manufactured by Nippon Polypro Co., Ltd.
  • the metallocene low-density polyethylene resin is a low-density polyethylene resin obtained using a metallocene catalyst, and in particular, a metallocene linear low-density polyethylene resin (M-LLDPE), that is, ethylene and A copolymer with an ⁇ -olefin having 3 to 13 carbon atoms (ethylene content: 86 to 99.5 mol%) is preferred.
  • M-LLDPE metallocene linear low-density polyethylene resin
  • ⁇ -olefin include propylene, butene-1, hexene-1, 4-methylpentene-1, octene-1, decene-1, dodecene-1, and the like.
  • M-LLDPE The MI of M-LLDPE is usually 0.1 to 20 g / min (230 ° C.).
  • Examples of commercially available products of M-LLDPE include “Kernel” (trade name) and “Harmolex” (trade name) manufactured by Nippon Polyethylene Corporation.
  • Both the D layer and the E layer are composed of a polyolefin-based thermoplastic elastomer (TPO).
  • TPO polyolefin-based thermoplastic elastomer
  • TPO for example, a compound type produced by mechanically dispersing and compounding ethylene / propylene rubber in polypropylene with a kneader, a large amount of ethylene / propylene rubber is introduced into propylene by polymerization. Any of the reactor types may be used.
  • the flexural modulus (MPa) is adjusted by the amount of ethylene / propylene rubber used.
  • polyolefin thermoplastic elastomers having different flexural moduli (MPa) are used in the D layer and the E layer.
  • MPa flexural moduli
  • the D layer uses a polyolefin-based thermoplastic elastomer (TPO) having a flexural modulus of 300 (MPa) or less
  • the E layer uses a polyolefin-based thermoplastic elastomer (TPO) having a flexural modulus of 600-1500 (MPa). use.
  • the flexural modulus is a value measured according to JIS-K-7203. As described above, the flexural modulus of TPO of the D layer, which is the outer layer side, is smaller than that of the E layer, which is the inner layer side, so that flexibility after high-pressure steam sterilization is excellent. And, because of such flexibility, it has excellent impact resistance when falling.
  • the modulus of polyolefin-based thermoplastic elastomer (TPO) used for the D layer is preferably 100 (MPa) or less, and the lower limit is usually 30 (MPa).
  • the elastic modulus of polyolefin-based thermoplastic elastomer (TPO) used in the E layer is preferably 700 to 1300 (MPa).
  • the thicknesses of the A layer / B layer / C layer / D layer / E layer in the present invention are as follows.
  • the A layer is usually 3-30 ⁇ m, preferably 6-12 ⁇ m
  • the B layer is usually 5-40 ⁇ m, preferably 10-20 ⁇ m
  • the C layer is usually 10-100 ⁇ m, preferably 50-80 ⁇ m
  • the D layer is usually 10-60 ⁇ m
  • the thickness is preferably 30 to 50 ⁇ m
  • the E layer is usually 10 to 50 ⁇ m, preferably 15 to 30 ⁇ m.
  • the medical laminated film of the present invention can be produced by, for example, a downward water-cooled inflation molding method using a co-extruded annular die or a laminate method, and preferably a downward water-cooled inflation molding using a co-extruded annular die.
  • a downward water-cooled inflation molding method using a co-extruded annular die or a laminate method and preferably a downward water-cooled inflation molding using a co-extruded annular die.
  • Such a method usually uses a facility in which a water tank having a size ring inside is disposed below the annular die, and an an inner plate and a winding roll are sequentially disposed below the water tank. Then, co-extrusion of multiple types of raw resin from the annular die so as not to cause substantial stretching, and after passing through the sizing ring and cooling, the cylindrical body of the laminated film is wound up through the inner plate.
  • the water cooling method as described above has a higher cooling rate and a lower crystallinity than the air cooling method. As a result, there are advantages such that the adhesive strength between the respective layers can be increased, and a flexible and highly transparent laminated film can be obtained.
  • the cooling rate can be adjusted by the amount of cooling water and the cooling water temperature.
  • the medical laminated film of the present invention is excellent in both physical strength such as tensile strength and flexibility, it can be suitably used as a film for infusion bags, a drug solution for peritoneal dialysis, a back film for drainage, and the like. I can do it.
  • a laminated film formed in a tube shape is cut into a size of 22 cm ⁇ 30 cm and used as a sample.
  • an outer bag a bag made of a single layer of high-density polyethylene of 75 ⁇ m
  • seal it put it in a high-pressure steam sterilizer (“TOMY AUTOCLAVE SS-240” manufactured by Tommy Seiko Co., Ltd.), and hold at 121 ° C. for 60 minutes.
  • TOMY AUTOCLAVE SS-240 manufactured by Tommy Seiko Co., Ltd.
  • the sample is taken out, and after natural cooling, a 0.5 cm ⁇ 18 cm strip-like specimen is taken from each of the samples MD (vertical direction) and TD (horizontal direction), and placed in “Loop Stiffness Tester” manufactured by Toyo Seiki Seisakusho.
  • the specimen is deformed into an annular shape, and the maximum load (flexibility) applied to the load cell when the load cell is pushed about 1 cm at a low speed in the annular portion is measured.
  • Examples, Comparative Examples 1 and 2 Using a raw material resin shown in Table 1, a cylindrical body of a laminated film having a layer structure shown in Table 2 was manufactured by a downward water cooling molding method using a five-layer coextrusion annular die. The mold temperature of the extruder was 250 ° C., the cooling water temperature was 21 ° C., the cooling water amount was 10 L / min, and the winding speed was 15 m / min. The obtained cylindrical body was slit to a predetermined length, cut into a single laminated film, and subjected to the above-described evaluation of flexibility. The results are shown in Table 2.

Landscapes

  • Laminated Bodies (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Wrappers (AREA)

Abstract

L'invention porte sur un film médical stratifié doté d'une excellente flexibilité après stérilisation à la vapeur d'eau à haute pression. Le film médical stratifié de l'invention comprend au moins une couche (A), une couche (B), une couche (C), une couche (D) et une couche (E), laminées dans cet ordre, la couche (A) étant configurée à partir d'une résine de polyester ou d'une résine de polyamide, la couche (B) étant configurée à partir d'une résine adhésive, la couche (C) étant configurée à partir d'une couche de résine de polyoléfine, la couche (D) étant configurée à partir d'élastomères thermoplastiques de polyoléfine présentant un module d'élasticité en flexion de 300 MPa ou moins et la couche (E) étant configurée à partir d'un élastomère thermoplastique de polyoléfine présentant un module d'élasticité en flexion de 600-1 500 (MPa), et la couche (A) étant positionnée comme la couche la plus à l'extérieur et la couche (E) étant positionnée comme la couche la plus à l'intérieur.
PCT/JP2010/061783 2010-07-12 2010-07-12 Film médical stratifié WO2012008007A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
PCT/JP2010/061783 WO2012008007A1 (fr) 2010-07-12 2010-07-12 Film médical stratifié
JP2011510205A JP5278543B2 (ja) 2010-07-12 2010-07-12 医療用積層フィルム
SG2011016789A SG177232A1 (en) 2010-07-12 2010-07-12 Medical laminated film

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/JP2010/061783 WO2012008007A1 (fr) 2010-07-12 2010-07-12 Film médical stratifié

Publications (1)

Publication Number Publication Date
WO2012008007A1 true WO2012008007A1 (fr) 2012-01-19

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2010/061783 WO2012008007A1 (fr) 2010-07-12 2010-07-12 Film médical stratifié

Country Status (3)

Country Link
JP (1) JP5278543B2 (fr)
SG (1) SG177232A1 (fr)
WO (1) WO2012008007A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016186072A1 (fr) * 2015-05-18 2016-11-24 グンゼ株式会社 Film étiré en polypropylène, et sac d'emballage
JP2018058356A (ja) * 2016-09-30 2018-04-12 大日本印刷株式会社 積層体及び該積層体で構成される袋
WO2022210899A1 (fr) 2021-04-02 2022-10-06 三井化学株式会社 Film multicouche et récipient d'agent liquide

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001506200A (ja) * 1997-09-22 2001-05-15 バクスター インターナショナル インコーポレイテッド 医療用製品のための多層化ポリマー構造体
JP2002011839A (ja) * 2000-06-28 2002-01-15 Fujimori Kogyo Co Ltd 医療用液体容器用プラスチックフィルム
JP2002219786A (ja) * 2000-11-01 2002-08-06 Mitsubishi Engineering Plastics Corp 多層フィルム製の医療用液体収納袋

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001506200A (ja) * 1997-09-22 2001-05-15 バクスター インターナショナル インコーポレイテッド 医療用製品のための多層化ポリマー構造体
JP2002011839A (ja) * 2000-06-28 2002-01-15 Fujimori Kogyo Co Ltd 医療用液体容器用プラスチックフィルム
JP2002219786A (ja) * 2000-11-01 2002-08-06 Mitsubishi Engineering Plastics Corp 多層フィルム製の医療用液体収納袋

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016186072A1 (fr) * 2015-05-18 2016-11-24 グンゼ株式会社 Film étiré en polypropylène, et sac d'emballage
JP2018058356A (ja) * 2016-09-30 2018-04-12 大日本印刷株式会社 積層体及び該積層体で構成される袋
JP7124285B2 (ja) 2016-09-30 2022-08-24 大日本印刷株式会社 積層体及び該積層体で構成される袋
WO2022210899A1 (fr) 2021-04-02 2022-10-06 三井化学株式会社 Film multicouche et récipient d'agent liquide
KR20240004341A (ko) 2021-04-02 2024-01-11 가부시키가이샤 오츠카 세이야쿠 고죠 다층 필름 및 액제 용기

Also Published As

Publication number Publication date
JPWO2012008007A1 (ja) 2013-09-05
JP5278543B2 (ja) 2013-09-04
SG177232A1 (en) 2012-02-28

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