CN105599407A - Polymer films comprising copolyether-ester copolymers - Google Patents
Polymer films comprising copolyether-ester copolymers Download PDFInfo
- Publication number
- CN105599407A CN105599407A CN201510687028.1A CN201510687028A CN105599407A CN 105599407 A CN105599407 A CN 105599407A CN 201510687028 A CN201510687028 A CN 201510687028A CN 105599407 A CN105599407 A CN 105599407A
- Authority
- CN
- China
- Prior art keywords
- film
- solution
- pouch
- copolymer
- layer
- Prior art date
- Legal status (The legal status 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 status listed.)
- Pending
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
- B32B27/28—Layered products comprising a layer of synthetic resin comprising synthetic resins not wholly covered by any one of the sub-groups B32B27/30 - B32B27/42
- B32B27/285—Layered products comprising a layer of synthetic resin comprising synthetic resins not wholly covered by any one of the sub-groups B32B27/30 - B32B27/42 comprising polyethers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/10—Bag-type containers
-
- 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
- B32B27/28—Layered products comprising a layer of synthetic resin comprising synthetic resins not wholly covered by any one of the sub-groups B32B27/30 - B32B27/42
-
- 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
- B32B33/00—Layered products characterised by particular properties or particular surface features, e.g. particular surface coatings; Layered products designed for particular purposes not covered by another single class
-
- 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
- B32B2439/00—Containers; Receptacles
- B32B2439/80—Medical packaging
Landscapes
- Health & Medical Sciences (AREA)
- Hematology (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Wrappers (AREA)
Abstract
The present invention discloses "polymer films comprising copolyether-ester copolymers". The presently disclosed subject matter generally relates to multilayer films suitable for forming pouches, such as (but not limited to) medical solution pouches. When used to form solution pouches, the disclosed films help prevent or reduce the presence of air bubbles in the solution after heat sterilization (e.g., autoclaving). In particular, the presently disclosed subject matter provides a polymer film for forming pouches that can pass the bubble test as described in the chinese national drug packaging container material standard No. YBB 00112005. The disclosed films comprise at least one defoaming layer comprising a copolyether-ester copolymer.
Description
Technical field
Theme disclosed in this invention relates generally to the polymer film that is suitable for use in application widely. More specificallyGround, film disclosed in this invention is suitable for forming medication solution pouch, after heat sterilization, in packaged solution, does not have/hasThe bubble of reduction. By disclosed film formed medication solution pouch can by as at China national medicament packaging container materialBubble test described in No. YBB00112005th, material standard.
Background technology
Common practice is the solution that is provided for medical application with the form of disposable flexible pouch. Described pouch must meetMultiple performance standards, comprise that contractility, optically clear degree, transparency, high heat resistance and enough mechanical strength are to bearWherein use the stringency of their environment. Medication solution pouch also should provide enough that steam and other gas are passed throughIntercept the pollution of the solution being comprised to prevent wherein.
The heat sterilization of the medical pouch that comprises solution carries out approximately 15 to 30 minutes conventionally in autoclave under approximately 250 ℉Time. Conventionally, heat sterilization causes being packaged in the solution in described pouch and forms bubble, and this it is believed that it is due in autoclave processingThe migration of membrane component during this time causes. The existence of bubble may be unacceptable in some cases. For example,, for Chinese medical treatmentThe film of pouch must pass through " bubble test ", wherein after autoclaving and violent rocking, in packaged solution, formsAny bubble must dissipate rapidly.
It is useful that the flexible membrane that is applicable to manufacture medication solution pouch is provided. If by disclosed film formed solutionPouch have reduction for the degree (proficiency) that forms bubble after heat sterilization in packaged solution, soThis is also favourable.
Summary of the invention
In some embodiments, theme disclosed in this invention relates to the polymer film that comprises at least one froth breaking layer, whereinApproximately 25 to 100 % by weight copolymerization ether-ester copolymers that described froth breaking layer comprises the gross weight based on described layer and based on described layerApproximately 0 to 75 % by weight polyamide, polyester, polyolefin or its combination of gross weight.
In some embodiments, disclosed film can be used to form pouch. Particularly, described pouch can comprise withAspectant relation is directed and seal each other to limit betwixt front sheet material and the rear sheet material of inner compartment along adjacent lateral edges.
In some embodiments, theme disclosed in this invention relates to after heat sterilization and to reduce or to prevent from being included in pouchIn interior solution, form the method for bubble. Particularly, described method comprises extrudes disclosed film, and makes described film form toolThe pouch that is useful on the inner space that receives medication solution, wherein, in the time that medication solution is packaged in wherein, described pouch canBy as No. YBB0112005th, China national medicament packaging container material standard described in bubble test.
Detailed description of the invention
I. overall Consideration
Generally speaking theme disclosed in this invention relates to the polymer film that is applicable to form pouch, for example (but being not limited to) medical treatmentSolution pouch. In the time being used to form solution pouch, disclosed film contributes to prevent or reduces at heat sterilization (as autoclaving)After the bubble that exists in packaged solution. Particularly, disclosed film can be used for form can by as in Chinese stateThe pouch of the bubble test described in No. YBB00112005th, family's medicament packaging container material standard. Disclosed film comprise toA few froth breaking layer, it comprises copolymerization ether-ester copolymer, as hereinafter more elaborated.
II. definition
Follow long-term Patent Law convention, when term " ", " one " and " being somebody's turn to do/described " are for including claimsThe application in time refer to " one or more/one or more ". Therefore, for example, mention that " film " comprises multiple suchFilm, the rest may be inferred.
As used herein term " adjacent " refer between them, there is or do not have intermediate layer (for example tack coat), stickyThe location of two retes that contact with each other in the situation of mixture or other layer.
As used herein, the term " obstruct " and " barrier layer " that are applied to film and/or rete refer to that film or rete serve asThe ability of the barriers to gas and/or smell. Can be used for the polymeric material with low oxygen transmitance in such layerExample can comprise: ethylene/vinyl alcohol copolymer (EVOH), polyvinylidene chloride (PVDC), vinylidene chloride copolymer are (as partiallyDichloroethylene/methyl acrylate copolymer, vinylidene chloride/vinyl chloride copolymer), polyamide, copolyamide, polyester, poly-secondAlkyd, polyacrylonitrile (can be used as BarexTMResin obtains) or its blend. Oxygen barrier material can further comprise producing to be usedFor example, in the high length-diameter ratio filler (, nano composite material) of the zigzag path permeating. Can (remove as organic by introducing oxygen scavengerOxygen agent) further strengthen oxygen barrier property. In some embodiments, metal forming, metalized substrate (for example, metallizationPETG (PET), metallized polyimide acid amides and/or metallized polypropylene) and/or comprise SiOx or AlOxThe coating of compound can be used for providing low oxygen transmitance for packaging. In some embodiments, barrier layer can have basisASTMD-3985 is less than or equal to about 2000cc/m under 73 ℉2/ 24 hours/atm, in some embodiments under 73 ℉Be less than about 1500cc/m2/ 24 hours/atm, under 73 ℉, be less than about 1000cc/m in some embodiments2/ 24 hours/Atm and be less than in some embodiments about 500cc/m under 73 ℉2The gas (for example, oxygen) of/24 hours/atm oozesRate thoroughly. The full content of all ASTM through quoting is incorporated to herein by reference at this.
Term " body layer (bulklayer) " refers to the mechanical bruise resistance (abuse-for increasing film as used hereinResistance), the layer of toughness, modulus etc. In some embodiments, described body layer can comprise polyolefin and (comprises but notBe limited to) at least one be selected from comprise ethylene/alpha-olefin copolymer, ethylene/alpha-olefin copolymer plastic body, low density polyethylene (LDPE),And/or the member of the group of LLDPE and polyethylene-vinyl acetate copolymer.
Term " direct neighbor " refers between them without any tack coat, adhesive or other layer as used hereinSituation under the adjacent film layers that contacts with each other.
Term " ethylene/alpha-olefin copolymer " refers to such dissimilar materials, for example low density polyethylene as used hereinAlkene (LDPE), linear density polyethylene (LMDPE), LLDPE (LLDPE) and very low density polyethylene andUltra-low density polyethylene (VLDPE and ULDPE); And homogeneous polymers, the Ziegler/Natta catalysis for example being provided by DowDowlexSC2107 ethylene/alpha-olefin copolymer. These materials generally include ethene and one or more are selected from C4 to C10The copolymer of the comonomer of alpha-olefin (for example butylene (, 1-butylene), 1-hexene, 1-octene etc.), wherein said copolymerMolecule comprise and there is relatively less side chain branch or the long-chain of cross-linked structure. Other ethylene/alpha-olefin copolymer (for example originallyThe homogeneous ethylene/alpha-olefin copolymer of known long chain branching in field) be also included within.
Term " film " can use with general meaning as used herein, comprises plastic wire, no matter it be film orSheet material.
Term " polymer " as used herein " refer to the product of polymerisation, and can comprise homopolymers, copolymer,Terpolymer etc. In some embodiments, film layer can substantially be formed by single polymer, maybe can have withIt is the other polymer of (with its blend) together.
Term " polymer " film as used herein " refer to a kind of thermoplastic, be generally the form of sheet material or net, toolThere are one or more polymeric materials by combining by any routine or suitable method or other material to formLayer, described method comprises following one or more: coextrusion, extrusion coated, stacked, vapour deposition coating etc.
Term " pouch " comprises bag, container and any sealing that can hold product (as medication solution) as used hereinPackaging.
Term " sealing " refers to appointing of the first area of outer membrane face and the second area of outer membrane face as used hereinWhat sealing, comprises the sealing of jointing material, heat or other form of heat seal or any type. In some embodiments, instituteStating sealing can form by described region being heated to at least its sealing initiation temperature separately. Described sealing can be by eachAny or multiple carrying out in kind method, described method includes, but is not limited to use heat seal technology (for example, beadSealing, heat seal, pulse sealing, dielectric sealing, radio frequency sealing, ultrasonic sealing, hot-air, heating wire, infrared wire spokePenetrate).
Phrase " sealant (seallayer) ", " sealant (sealinglayer) ", " heat seal as used hereinLayer " and " sealant layer " refer to participation described film and himself, its another rete or another film and/or another non-film systemThe outside rete (one or more layers) of the sealing of product. It should also be appreciated that in the ordinary course of things the outside 1-10 of as many as of described filmMil can participate in the sealing of film and himself or another layer. Conventionally the sealant layer bag, sealing by heat sealing layerContaining any thermoplastic polymer. In some embodiments, described heat sealing layer can comprise, for example, and TPO, heatPlastic polyamide, thermoplastic polyester and thermoplastic polyvinyl chloride. In some embodiments, described heat sealing layer can comprise thermoplasticProperty polyolefin.
Term " cortex " refers to the skin of multilayer film as used herein. Outside rete is like this depositing through packaging productDuring storage and processing, be subject to mechanical wear (abuse).
Term " tack coat " refers to and has the inside rete that makes two layers main purpose bonded to each other as used herein.In some embodiments, tack coat can comprise any non-polar polymer with grafting polar group thereon, fromAnd make the described polymer can be covalently bonded to polar polymer (as polyamide, PGA and/or ethylene/vinyl alcohol copolymer).In some embodiments, tack coat can comprise at least one and is selected from and includes but not limited to improved polyalkene, ethene improved/secondThe member of the group of vinyl acetate copolymer and/or homogeneous ethylene/alpha-olefin copolymer. In some embodiments, tack coat canTo comprise freely anhydride modified grafted linear low-density polyethylene, acid anhydride-grafted low density polyethylene (LDPE), all of at least one choosingThe member of the group that matter ethylene/alpha-olefin copolymer and/or acid anhydride-grafted ethylene/vinyl acetate form.
All composition percentage used herein all represents based on " by weight ", unless otherwise specified.
Although most above-mentioned definition substantially as understood by those skilled, in above-mentioned definitionOne or more can be hereinbefore definition in the mode that is different from the implication that those skilled in the art understand conventionally, rootAccording to specific descriptions in this article of theme disclosed in this invention and determine.
Than any inconsistent definition and disclosure that may be present in the bibliography being merged in, with this ShenDefinition and disclosure are please as the criterion.
III. film disclosed in this invention
III.A. totally discuss
Theme disclosed in this invention can be presented as many different forms, and should not be construed as limited in this article and explainThe embodiment of stating. Comparatively speaking, disclosed embodiment is to provide in order to meet applicable legal requiremnt.
Theme disclosed in this invention relate to the flexible pouch that can be used for being formed for packaging and use medication solution andThere is the polymer film that forms the degree of bubble after heat sterilization in solution of reduction. Have been found that copolymerization ether-ester copolymerIntroduce the formation that can contribute to prevent or reduce bubble in the one or more layer of disclosed film.
Be not limited to any concrete theory, but it is believed that polymer film comprises that additive and other can lead to during heat sterilizationCross described film and move and enter the component in packaged solution. These components can also comprise and contain unreacted or part is anti-Monomer, dimer and the trimerical residue of answering. Have been found that described copolymerization ether-ester copolymer is at one of described pouch filmExistence in individual or multiple layers can prevent or contribute to other component that prevents residue and described film to move to pouch contentIn thing. Result is can reduce or prevent in packaged solution, to form bubble after heat sterilization. Especially, by disclosedPouch that film forms can be by according to by the desired test method in state food and drug administration (SFDA)" bubble test ". Described bubble test is described in No. YBB0112005th, national drug packing container material standard, in itHold thus by reference entirety be incorporated to.
Disclosed film can be single or multiple lift. Therefore, in some embodiments, disclosed film comprise one orMultiple layers are to introduce multiple performance (as sealing, air-tightness and toughness) in single film. Therefore, in some embodiments,Disclosed film comprises 1 to approximately 20 layer of total; In some embodiments, disclosed film comprises 2 to approximately 12 layers of totals; AndIn some embodiments, disclosed film comprises 4 to approximately 9 layers of totals. Therefore, disclosed film can comprise 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19 or 20 layers. Those of ordinary skill in the art also will recognize, institute's public affairsThe film of opening can comprise and exceed 20 layers, and for example described membrane component comprises microbedding technology (microlayering thereinTechnology) in embodiment.
Disclosed film can have any required gross thickness, as long as described film provides for wherein using described filmThe performance that concrete packaging operation is required, such as optical property, modulus, sealing intensity etc. Final web thickness is passableNot etc., this depends on processing, final use application etc. Typical thickness can be 0.1 to 20 mil; In some embodimentsIn, thickness can be 0.3 to 15 mil; In some embodiments, thickness can be 0.5 to 10 mil; In some enforcement sidesIn case, thickness can be 1 to 8 mil; In some embodiments, thickness can be 1 to 4 mil; And in some embodimentsIn, thickness can be 1 to 2 mil. Therefore, in some embodiments, described film can have 10 mils or less thickness; ?In some embodiments, described film can have 5 mils or less thickness. Those of ordinary skill in the art also will recognize,Theme disclosed in this invention also comprises the wherein embodiment of film outside scope described herein.
III.B. froth breaking layer
As described herein, disclosed film comprises the froth breaking layer that at least one comprises copolymerization ether-ester copolymer. Be applicable to disclosedFilm in copolymerization ether-ester block copolymer comprise the hard chain of terephthalic acid (TPA) alkylene ester replacing with poly-[alkylene oxide] soft chain segmentSection. Aliphatic series soft chain segment can include, but is not limited to hydroxy-end capped polyethers (for example PEO glycol, PPOX twoAlcohol, poly-[oxolane] glycol) and ethylene oxide-capped polyester (for example polycaprolactone glycol and poly adipate succinic acid ester twoAlcohol). In some embodiments, described hard segment comprises polybutylene terephthalate (PBT), C5-C20The poly-terephthaldehyde of alkeneAcid butanediol ester or more senior terephthalate or isophthalic acid ester. The soft chain segment of disclosed block copolymer accounts for instituteState the approximately 10-70 % by weight of copolymer gross weight, there is corresponding 30 to 90 Shore D hardness (according to ASTMD2240/USI868). The DSC fusing point of described copolyesters-ether copolymer can be in the scope of about 140-220 DEG C, has about 100-210 DEG CVicat softening point.
The example of suitable business copolymerization ether-ester copolymer can include, but is not limited to Hytrel 952 (Shore D=55), Hytrel 966 (Shore D=63) and Hytrel 8238 (Shore D=82), its all can be available from DuPontDowElastomers (Wilmington, the Delaware State, the U.S.). Other example comprise Arnitel DM460 (Shore D=40),Arnitel EM630-H (Shore D=63) and Arnitel EL740 (Shore D=70), its all can be available from DSM (HaierHuman relations, Holland). Other example also comprise Polprene P30B (Shore D=29), Polprene P90B (Shore D=52) andPolprene E450B (Shore D=78), its all can be available from ToyoboCo.Ltd. (Osaka, Japan).
Described copolymerization ether-ester copolymer can exist with approximately 25 of the gross weight based on described layer to the amount of approximately 100 % by weightIn at least one froth breaking layer. Therefore, in some embodiments, described copolymerization ether-ester copolymer can be with based on described layerGross weight at least about (or being not more than) 25,30,35,40,45,50,55,60,65,70,75,80,85,90,95,99 orThe amount of 99.9 % by weight is present in described froth breaking layer. In some embodiments, described copolymerization ether-ester copolymer can be with multipleAny material blend in polymeric material as known in the art, described polymeric material include, but is not limited to polyamide,Merlon, polyester and/or its combination.
Described froth breaking layer can be any layer of disclosed film. For example, in some embodiments, froth breaking layer can be determinedPosition becomes outside rete. Or or in addition, in some embodiments, described froth breaking layer can be sealant layer, sandwich layer and/orAny intermediate layer (, the 2nd, 3,4 of for example 7-tunic layers).
III.C. additional rete
Disclosed film can comprise one or more mechanical wear layers, barrier layer, tack coat, sandwich layer and/or cortex, as thisField those of ordinary skill is known.
A case representation of the film of theme disclosed according to the present invention is A/B/C/D/E/F/G. " A " comprises at leastA kind of outside rete of copolymerization ether-ester copolymer. " B " is adjacent with " A " or direct neighbor and comprise maleic anhydride modified commonThe internal layer of polymers (for example maleic anhydride modified ethylene/methyl acrylate copolymer). " C " is on either side and " B " and " D "Directly or indirectly adjacent and comprise high density polyethylene (HDPE) homopolymers and/or at least one ethylene/alpha-olefin (for example extra-low densityEthylene/octene, linear low density ethylene/butylene copolymer, linear low density ethylene/hexene copolymer) internal layer." D " be positioned in adjacent with " E " with " C " on either side or direct neighbor and comprise low density polyethylene homopolymer and/orAt least one ethylene/alpha-olefin (for example extra-low density ethylene/octene copolymer or linear low density ethylene/hexene copolymer)Internal layer. " E " is positioned in adjacent with " F " with " D " on either side or direct neighbor and comprises at least one ethylene/alpha-olefin(for example extra-low density ethylene/octene copolymer, linear low density ethylene/hexene copolymer, linear low density ethylene/butylene are commonPolymers or high density polyethylene (HDPE) homopolymers) internal layer. " F " is positioned to or direct neighbor and bag adjacent with " G " with layer " E "Containing at least one ethylene/alpha-olefin (for example extra-low density ethylene/octene copolymer, linear low density ethylene/butylene copolymer,Propylene/ethylene copolymer) inside rete. " G " be inner rete and comprise at least one be selected from comprise styrene/ethylene/Butylene copolymer, linear low density ethylene/hexene copolymer, propylene/ethylene copolymer, ethylene copolymer or polypropylene copolymerizationThe member of the group of thing.
IV. manufacture the method for disclosed film
Disclosed film can be constructed by any suitable method known in the art, and described method includes, but is not limited toCoextrusion, stacked, extrusion coated and combination.Referring to, for example, authorizeMumpowerU.S. Patent number 6,769,227; AuthorizeThe people such as Brax3,741,253; AuthorizeThe people such as Brax4,278,738; AuthorizeSchirmer4,284,458; With authorizeSchoenberg4,551,380, it is incorporated in full herein by reference with it separately. Usually, described copolymerization ether-ester froth breakingComponent can, as additive blend in expressing technique process, as known in the art, or be used as pure(100%) component layers.
Disclosed film can form with the form of tubular film or with the form of planar film by curtain coating coextrusion. Be used forThe container of medical applications or other final use can directly be prepared by the tubular film of coextrusion, or will manage incision alternativelyWith after leafing, prepared by the coiled material being in control (rollstock) material. Hot technological process for blowing also can be used for preparing disclosedFilm, those that the optical property of the pouch still obtaining may be not so good as to be made up of curtain coating coetrusion. Other technique, for example, squeezeGo out coating, routine is stacked, channel mould is extruded etc. also can be used for manufacturing disclosed film, but these alternatives may be difficult to/Or efficiency is lower than method for optimizing.
In some embodiments, disclosed film can be cross-linked. As known in the art, the crosslinked film that improves existsStructural strength at the temperature raising and/or the raising power that material can be stretched before tearing under this power. In some enforcementIn scheme, can be by radiation, use particle radiation or non-particle radiation (for example, from high energy electron or cobalt-60 of acceleratorGamma-rays) bombard described film and complete crosslinked. In some embodiments, dose of radiation level is about 2-8 Megarad (MR). CanTo use the crosslinking technological of any routine, for example radiation of curtain bundle and/or chemical crosslinking (for example, using peroxide).
V. use the method for disclosed film
Disclosed film can be for structure any in the known and various pouches that use in this area. For example,, in medical treatmentIn the formation of pouch, skin serves as heat sealing layer. By this way, in the time that film is made to pouch, described in described skin will formThe inner surface of pouch, that is, and the surface contacting with packaged medication solution. When described film self folds or joins with another filmRight so that two regions of described layer while contacting with each other the first skin also form heat seal. After cooling, described outer field heatingPart becomes single, substantially inseparable layer. By this way, described outer field heated part produces impenetrable liquidHeat seal. In some embodiments, the heat seal limiting is generally all fin shape, and is joined together to limitThe peripheral border of fixed described pouch, makes medication solution to be completely enclosed within wherein. Theme disclosed according to the present inventionThe example of the medication solution that can pack and use includes, but is not limited to saline solution, dextrose solution, for the application of dialysingSolution etc.
In some embodiments, disclosed pouch comprises and is oriented at side and bottom margin face-to-face and solid each otherFixed front sheet material and rear sheet material. Conventionally, each edge is to have according to approximately 40 of ASTMF88 (its entirety is incorporated to herein)The heat seal of N/in or larger sealing intensity. But theme disclosed in this invention also comprises that wherein said edge comprises oneThe embodiment of individual or multiple frangible seal. In some embodiments, described front sheet material and rear sheet material comprise two independentSheet material or at an edge single sheets through the folding film in center. Described sheet material limit together have for receive solution inThe pouch of portion's compartment.
In some embodiments, disclosed pouch comprises and is suitable for the row that is communicated with the inner space fluid of described pouchDischarge port. In some embodiments, the intravenous injection (IV) that described exhaust outlet can be connected to standard is installed and/or is usedDevice, as known to those skilled. In some embodiments, described outlet can comprise one or more useIn the entrance of introducing the component in pouch inside to be closed. Therefore, theme disclosed in this invention comprises wherein said dischargeOutlet is served as for introducing component and discharging the enforcement of the dual role of the component of described pouch inside in the desired timeScheme. Disclosed pouch can also comprise support member, described support member can be for described pouch is connected to pedestal (asSupport) on hole, clip etc.
Can for example, by any suitable shape known in disclosed pouch constructions cost field and that use, (but notBe limited to) ampuliform, plate-like, box-like and tubulose. For this purpose, the shape and size of disclosed pouch can be used according to its expectionWay changes with needing, as one of ordinary skill in the understanding.
Disclosed pouch can be in many ways any prepare. For example, in some embodiments, described capsuleBag can be prepared by the multilayer film roller of two windings, wherein by described sheet separation to form front pouch sheet material or rear pouch sheet material.Independent sheet material subsequently can be substantially parallel mode transmission. In other embodiments, described front sheet material and rear sheet material can be byTubular film forms or is formed by the film sheet providing in independent feed rolls. In some embodiments, any unnecessary sheetMaterial material can around be pruned from pouch periphery heat seal. If needed, described front pouch sheet material and rear pouch sheet material can printBe brushed with any required identification information.
Described pouch through manufacture, sealing and fill after, then can be by its sterilizing. Autoclaving is generally used forMake medical fluid and equipment sterilizing. In some embodiments, before or after sterilizing, described pouch can be put into and served asDust cover also contributes to protect pouch content to avoid the plastics of the impacts such as outside external contaminant, water loss, gas permeationIn external packing or container.
The pouch having contacted for packing medication solution is described disclosed film. But, should be understood thatOther application of described film is also possible and within the scope of theme disclosed in this invention.
VI. the advantage of theme disclosed in this invention
Pouch disclosed in this invention reduces or prevents the formation of bubble, and thus can be by according to by China national food medicineThe desired test method of product Surveillance Authority, be described in national drug packing container material standard No. YBB00112005In " bubble test ".
Can also produce more at an easy rate disclosed film than the film of similar prior art. In some embodiments, systemMake disclosed film and can save 20-40%.
Although at length set forth in this article some advantages of disclosed system, this list is restricted anything but. Especially, those of ordinary skill in the art will recognize, can exist several not to be included in herein disclosedThe advantage of film and method.
Embodiment
Following examples provide illustrative embodiment. According to present disclosure and technical staff's mean level,Those of ordinary skill in the art will understand, and it is only exemplary that the following examples are intended to, and not depart from institute of the present inventionUnder the scope of disclosed theme, can adopt many variations, modifications and changes.
Several membrane structures of theme disclosed according to the present invention and comparative are determined in table 1 below and table 2.
Table 1
Resin identification
A is styrene/ethylene/butene terpolymers.
B is propylene/ethylene copolymer.
C is extra-low density ethylene/octene copolymer, and it has flow velocity (E-028) and the 0.867-of 0.75-1.25g/10minThe density (E-112) of 0.873g/cc.
D is linear low density ethylene/butylene copolymer.
E is extra-low density ethylene/octene copolymer, its have 0.903-0.908g/cc density (E-112, at 23 DEG C),The bulk density (E-062) of 0.53g/cc and the DSC melt temperature of 123 DEG C.
F is linear low density ethylene/hexene copolymer.
G is low density polyethylene homopolymer.
H is 10% amide waxe in LLDPE carrier.
I is high density polyethylene (HDPE) homopolymers.
J is maleic anhydride modified ethylene/methyl acrylate copolymer.
K is copolyesters, and it has the density (E-112) of DSC fusing point and the 1.13g/cc of 195-215 DEG C.
L is the smooth master batch that contains 20%PDMS in polyamide 6.
M is polyester block copolymerization ether-ester.
N is maleic anhydride modified polyethylene, and it has the melt index (MI) of 1.9-2.9.
O is styrene/ethylene/butylene copolymer, and it has 0.91 proportion, the styrene of 27:71: rubber ratio and 350-600The solution viscosity of centipoise (20 % by weight solution at 25 DEG C in toluene).
P is linear low density ethylene/hexene copolymer, its have 1.7-2.3 degree/min melt index (MI) (E-028) andThe density (E-112) of 0.908-0.912g/cc.
Q is extra-low density ethylene/octene copolymer.
R is the fining agent in polypropylene.
T is high density ethylene/butylene copolymer.
U is antiblocking agent, and it has the density (E-112) of 2.1g/cc.
V is propylene/ethylene copolymer, and it has the flow velocity (E-028) of 6.0-9.0g/10min and 0.895-0.905g/ccDensity (E-112).
W is ethylene copolymer.
X is polypropylene copolymer.
Y is phenol antioxidant.
Table 2
Film identification
Embodiment 1
The preparation of film 1-14
Manufacture film 1-14 by curtain coating coextrusion. This method is well known to those of ordinary skill in the art.
Embodiment 2
The wash-out bubble test of film 1-13
Film 1-14 is carried out to the wash-out bubble test of introducing in SFDA standard YBB0112005, as for packing infusion productsMedical film and bag required passing through/fail criteria.
For film 1-14, by the 600cm of film2??Inside portion cut into the section of 5cm × 0.5cm. By described sectionWash with water and be at room temperature dried. Then described section is put into the 500mL conical flask that contains 200mL water. Described in inciting somebody to actionBottle seals and puts into autoclave sterilizer sterilizing 30 minutes at the temperature of 121 DEG C. Then by described bottle cool to room temperature.From described bottle, take out the aqua sterilisa of 5mL and put into tool plug standard test tube (internal diameter is 15mm and is highly 200mm). WillDescribed test tube thermal agitation 3 minutes, then leaves standstill the time of 3 minutes. For tested each film, this experiment is repeated 16 times.
The test tube that gives " passing through " grade does not have bubble in the time that the standing phase finishes. The test tube that gives " failure " grade is leaving standstillAfter finishing, there are phase residual one or more bubbles. Described wash-out bubble test the results are shown in table 3 below.
Table 3
The wash-out bubble test result of film 1-14
From the conclusion of embodiment 2
Result (particularly, film 3-8 and 10-14) from embodiment 2 shows to use the copolymerization of copolymerization ether-ester in sandwich constructionThing makes described film can pass through bubble test (, No. YBB0112005th, China national medicament packaging container material standard).
Claims (14)
1. polymer film, it comprises at least one froth breaking layer, and wherein said froth breaking layer comprises the approximately 25-based on described layer gross weightPolyamide, polyester, the polyene of the copolymerization ether-ester copolymer of 100 % by weight and the approximately 0-75 % by weight based on described layer gross weightHydrocarbon or its combination.
2. the film of claim 1, wherein said copolymerization ether-ester copolymer comprises the terephthalic acid (TPA) Asia replacing with poly-(alkylene oxide)Arrcostab.
3. the film of claim 1, wherein said film is that multilayer film and described froth breaking layer are outside retes.
4. the film of claim 1, it is adjacent with outside rete or straight that wherein said film is that multilayer film and described froth breaking layer are positioned toConnect adjacent.
5. the film of claim 1, wherein said film can by as in China national medicament packaging container material standard theBubble test described in No. YBB0112005.
6. by the film formed pouch of claim 1, wherein said pouch comprises with aspectant relation orientation and along adjacentLateral edges seals to limit betwixt front sheet material and the rear sheet material of inner compartment each other.
7. the pouch of claim 6, wherein said copolymerization ether-ester copolymer comprises the terephthalic acid (TPA) replacing with poly-(alkylene oxide)Alkylene ester.
8. the pouch of claim 6, wherein said film can by as in China national medicament packaging container material standard theThe bubble test of setting forth in No. YBB0112005.
9. the pouch of claim 6, it is further included in the solution comprising in described inner bladder compartment.
10. the pouch of claim 9, wherein said solution is selected from and comprises: water, saline solution, buffer solution, Ringer's solution, dextrorotationThe group of sugar juice, Hunk solution, glucose solution and combination thereof.
11. reduce or the solution that prevents from comprising in pouch after heat sterilization in form the method for bubble, described method comprises:
A. extrude the film of claim 1;
B. make described film form the pouch with the inner space for receiving medication solution, wherein when medication solution is packedTherein time, described pouch can by as No. YBB0112005th, China national medicament packaging container material standard described inBubble test.
The method of 12. claims 11, wherein said copolymerization ether-ester copolymer comprises the terephthaldehyde who replaces with poly-(alkylene oxide)Acid alkylene ester.
The method of 13. claims 11, it further comprises by the opening in described pouch introduces medication solution wherein alsoBy the step of the described opening sealing of closure.
The method of 14. claims 11, wherein said solution is selected from and comprises: water, saline solution, buffer solution, Ringer's solution, dextrorotationThe group of sugar juice, Hunk solution, glucose solution and combination thereof.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201462066956P | 2014-10-22 | 2014-10-22 | |
| US62/066956 | 2014-10-22 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN105599407A true CN105599407A (en) | 2016-05-25 |
Family
ID=55979993
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510687028.1A Pending CN105599407A (en) | 2014-10-22 | 2015-10-22 | Polymer films comprising copolyether-ester copolymers |
Country Status (2)
| Country | Link |
|---|---|
| CN (1) | CN105599407A (en) |
| BR (1) | BR102015026556A2 (en) |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2005298555A (en) * | 2004-04-07 | 2005-10-27 | Mitsubishi Chemicals Corp | Polyester, method for producing the same and medical device using the polyester |
| JP2010070613A (en) * | 2008-09-17 | 2010-04-02 | Mitsubishi Chemicals Corp | Polyether ester block copolymer composition and molded medical product thereof |
| CN102802940A (en) * | 2009-04-07 | 2012-11-28 | 克里奥瓦克公司 | Multilayer film for medical solution pouch having reduced degree of bubble formation |
-
2015
- 2015-10-20 BR BR102015026556A patent/BR102015026556A2/en not_active Application Discontinuation
- 2015-10-22 CN CN201510687028.1A patent/CN105599407A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2005298555A (en) * | 2004-04-07 | 2005-10-27 | Mitsubishi Chemicals Corp | Polyester, method for producing the same and medical device using the polyester |
| JP2010070613A (en) * | 2008-09-17 | 2010-04-02 | Mitsubishi Chemicals Corp | Polyether ester block copolymer composition and molded medical product thereof |
| CN102802940A (en) * | 2009-04-07 | 2012-11-28 | 克里奥瓦克公司 | Multilayer film for medical solution pouch having reduced degree of bubble formation |
Non-Patent Citations (2)
| Title |
|---|
| 廖双泉等: "聚醚酯热塑性弹性体", 《热塑性弹性体及其应用》 * |
| 郭静: "共混改性", 《高分子材料改性》 * |
Also Published As
| Publication number | Publication date |
|---|---|
| BR102015026556A2 (en) | 2016-09-20 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| JP2744132B2 (en) | Multilayer film structure | |
| US8273447B2 (en) | Multilayer oriented film | |
| US3932692A (en) | Resinious laminates having improved gas permeation and delamination resistance | |
| CN101052676B (en) | Composition comprising ethylene - acrylate copolymer and polyolefin and tackifier | |
| CN101018820B (en) | Composition comprising ethylene copolymers and polyolefins | |
| EP3233486B1 (en) | Multilayer film structures comprising delamination layer | |
| US20110039098A1 (en) | Gas-barrier films and sheets | |
| CN107031151A (en) | Multilayer film for medical solution pouch having reduced degree of bubble formation | |
| US20180264787A1 (en) | Multilayer food casing or food film | |
| JPH04226751A (en) | High melt flow polypropylene film for medical treatment | |
| WO2006043459A1 (en) | Gas barrier film for medical use and medical bags made by using the same | |
| CN110475722B (en) | Film having retort shock recovery | |
| JPH0657444B2 (en) | Laminate | |
| CN112041161B (en) | Spout bag and method for manufacturing the same | |
| EP0707955A1 (en) | Film/substrate composite material | |
| KR20210019988A (en) | Resin composition for liquid-repellent layer formation, and liquid-repellent film, liquid-repellent laminate, packaging material and container using the same | |
| JPH0378255B2 (en) | ||
| JP2015024593A (en) | Multilayer film and package | |
| EP0787781B1 (en) | 4-methyl-1-pentene resin composition and a laminated body using the resin composition | |
| JP5845575B2 (en) | Linear tearable transparent laminated film, and laminate and packaging bag using the same | |
| US20020015811A1 (en) | Film/substrate composite material | |
| CN105599407A (en) | Polymer films comprising copolyether-ester copolymers | |
| US20170114195A1 (en) | Polymeric Film Comprising Copolyether-Ester Copolymer | |
| JP2010120255A (en) | Multilayer film, sheet, and bag | |
| WO2019199743A1 (en) | Autoclavable barrier film |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| WD01 | Invention patent application deemed withdrawn after publication | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20160525 |