CN105619981B - A kind of medical package easily takes off film and preparation method thereof - Google Patents

A kind of medical package easily takes off film and preparation method thereof Download PDF

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Publication number
CN105619981B
CN105619981B CN201510976659.5A CN201510976659A CN105619981B CN 105619981 B CN105619981 B CN 105619981B CN 201510976659 A CN201510976659 A CN 201510976659A CN 105619981 B CN105619981 B CN 105619981B
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layer
thermal synthesis
10min
polyethylene
film
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CN105619981A (en
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王光华
程立坤
刘子明
徐小明
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HUBEI HENGTAI RUBBER CO Ltd
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HUBEI HENGTAI RUBBER CO Ltd
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    • 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
    • B32B27/36—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
    • B32B2250/00—Layers arrangement
    • B32B2250/03—3 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
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/30—Properties of the layers or laminate having particular thermal properties
    • B32B2307/306—Resistant to heat
    • 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
    • B32B2307/30—Properties of the layers or laminate having particular thermal properties
    • B32B2307/31—Heat sealable
    • 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
    • B32B2307/40—Properties of the layers or laminate having particular optical properties
    • B32B2307/412—Transparent
    • 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
    • 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

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  • Packages (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

The invention discloses a kind of medical packages easily to take off film and preparation method thereof.The medical package easily takes off film, including four-layer structure, is followed successively by from the inside to the outside：Thermal synthesis layer, structure sheaf, adhesive layer, outer layer；Wherein, the hybrid resin that the thermal synthesis layer is made of the polyethylene, ethylene vinyl acetate and ethylene methyl acrylate of medical grade is constituted；The structure sheaf is made of the polyethylene of medical grade；The adhesive layer is made of maleic anhydride modified ethylene octene copolymer；The outer layer is made of polyester elastomer.121~135 DEG C of high-temperature steams or gamma-ray irradiation sterilizing not only may be used in the present invention, can also be stored under the conditions of less than 25 DEG C.In addition, membrane material transparency is good, migration precipitation object is few, and drug compatibility is excellent, and has splendid easy taking off property, disclosure satisfy that the performance requirement of medical package, improves convenience and the safety of patient's medication.

Description

A kind of medical package easily takes off film and preparation method thereof
Technical field
The present invention relates to the technical fields of medical package material, more specifically refer to that a kind of medical package easily takes off film and its system Preparation Method.
Background technology
Medical package film has larger market potential, and drug, medical instrument be to the more demanding of packaging film, not only Flexibility, barrier property, the transparency etc. of guarantee film are needed, it is also contemplated that it is sterilizing and is ensuring that content is steady in storage condition It is fixed, it not will produce poisonous and harmful substance migration Adsorption Effect security performance.Based on this, people are just actively studying various for medicine The new packaging material of product, medical device package, to meet medical package various aspects and multi-level rigors in performance.
In the past, people often had found that commodity bundle pack was difficult opening, or in some cup bodies packaging during routine use Epiphragma and cup body are all " dead envelopes ", it is difficult to which epiphragma is opened from cup body, suchlike situation is brought many to consumer It is inconvenient.And in recent years manufacturer all slowly pay close attention to this problem, product packaging increasingly hommization, therefore easy opening packaging also at For the research direction of Flexible-Packaging Industry.According to opening ways difference, easy opening packaging divides easy-tear type and easy-to-uncover.Easy-tear type master It to be realized by way of beating tearing port, tear line in packaging bag or easily tearing composite membrane, and easily take off packaging and mainly control The heat sealing strength of packaging material so that the effect of sealing can be played after packaging material heat seal and destroyed by power appropriate Thermal synthesis layer is opened.
Currently, domestic and international medical package is easily taken off film production method and is mainly had：Dry type is compound, solvent-free compound, multi-layer co-extruded Squeeze out etc..The characteristics of it is a kind of most complex method of current domestic application that dry type is compound, technique is easy to operate, and interlayer is taken With also versatile and flexible, but its maximum defect is that thermal synthesis layer is easy to be glued agent exudation pollution, causes heat sealing strength stability poor, Organic solvent in another adhesive is difficult to remove, and is susceptible to the exceeded situation of dissolvent residual, and waste of energy, and dry is useless Gas and organic solvent volatilization also pollute the environment.No solvent residue in solvent-free compound production process, exhaust gas discharge of low pollution Environment is small, but because the ratio control of host agent and curing agent is unstable, and manufacturing condition is complicated, of high cost, splitting power Small equal factors are not used widely.Current most promising multi-layer co-extruded extrusion method, it is to use three or more Extruder, by the resin raw material of different function such as nylon (PA), polyethylene (PE), polypropylene (PP) etc. respectively melting extrusion, By respective runner, co-extrusion is converged at die head, is molded using casting and stretching or inflation, and cooling co-extrusion is together.Multilayer is total Crowded packaging film can not only meet the needs of various medical packages very well, have the advantages that dry type composite membrane is incomparable, may be used also The film for being gone out different performance with flexible design is easy to adjust heat seal layer material, meets the needs of Different Package.But at present both at home and abroad Co-extrusion medical package easily takes off membrane structure and material selection is unreasonable, has the disadvantage that：
(1) structure cannot meet less than -25 DEG C of low-temperature storages and gamma-ray irradiation sterilizing based on polypropylene (PP), hold Low temperature brittleness and irradiation to crack are easily caused, the health of human body is unfavorable for.
(2) structure cannot meet 121~135 DEG C based on polyethylene (PE), and 30min high-temp steam sterilizing technologies are wanted It asks, polyethylene (PE) fusing point is low, high temperature resistance is poor, and contraction and fold are easy tod produce after high-temp steam sterilizing.
(3) structure based on nylon (PA), polyethylene (PE) or polypropylene (PP), nylon (PA) is as surface layer in high temperature When steam sterilizing, absorbs water after nylon (PA) sterilizing and be susceptible to albinism, light transmittance is low, mist degree is big, and there are drug safety wind Danger；When gamma-ray irradiation sterilizes, amido bond is easily broken off in nylon (PA), and the browning of membrane material surface and membrane material leachable is caused to increase Add, these substances are readily migrate into packing material or packed article absorption.
Invention content
Present invention aim to provide a kind of medical package easily to take off film and preparation method thereof.The medical package easily takes off film 121~135 DEG C of high-temperature steams or gamma-ray irradiation sterilizing not only may be used, can also be stored under the conditions of less than -25 DEG C.This Outside, membrane material transparency is good, and migration precipitation object is few, and drug compatibility is excellent, and has splendid easy taking off property, disclosure satisfy that medical The performance requirement of packaging improves convenience and the safety of patient's medication.
To achieve the above object, a kind of medical package provided by the invention easily takes off film, it includes four-layer structure, from the inside to the outside It is followed successively by：Thermal synthesis layer, structure sheaf, adhesive layer, outer layer；Wherein, polyethylene of the thermal synthesis layer by medical grade, ethylene-acetate second The hybrid resin of enester and ethylene-methyl acrylate composition is constituted；The structure sheaf is made of the polyethylene of medical grade；It is described viscous Layer is closed to be made of maleic anhydride modified ethylene octene copolymer；The outer layer is made of polyester elastomer.
Further, the raw material percentage of the thermal synthesis layer includes：Polyethylene 30~80%, ethylene-acetate Vinyl acetate 10~40%, ethylene-methyl acrylate 10~30%.
Preferably, the raw material percentage of the thermal synthesis layer includes：Polyethylene 50~70%, second Alkene-vinyl acetate 15~25%, ethylene-methyl acrylate 15~25%.
Further, in the thermal synthesis layer polyethylene melt flow index be 0.5~10g/10min, fusing point be 80~ 120 DEG C, density is 0.89~0.94g/cm3；In the thermal synthesis layer melt flow index of ethane-acetic acid ethyenyl ester be 0.5~ 5g/10min, wherein vinyl acetate content is 5~30%；The melt flows of ethylene-methyl acrylate refer in the thermal synthesis layer Number is 0.5~10g/10min, wherein methyl acrylate content is 10~35%.
Preferably, the melt flow index of polyethylene is 1~5g/10min, fusing point 90 in the thermal synthesis layer ~115 DEG C, density is 0.90~0.93gg/cm3；In the thermal synthesis layer melt flow index of ethane-acetic acid ethyenyl ester be 1~ 3g/10min, wherein vinyl acetate content is 8~25%；The melt flows of ethylene-methyl acrylate refer in the thermal synthesis layer Number is 2~8g/10min, wherein methyl acrylate content is 15~30%.
Further, in the structure sheaf polyethylene melt flow index be 0.3~8g/10min, fusing point be 90~ 125 DEG C, density is 0.89~0.96g/cm3。
Preferably, the melt flow index of polyethylene is 0.5~5g/10min in the structure sheaf, and fusing point is 95~115 DEG C, density is 0.90~0.94g/cm3。
Further, in the adhesive layer maleic anhydride modified ethylene octene copolymer melt flow index be 0.3~ 10g/10min, fusing point are 45~95 DEG C, wherein maleic anhydride content is 0.1~3%, and density is 0.85~0.90g/cm3。
Preferably, the melt flow index of maleic anhydride modified ethylene octene copolymer is in the adhesive layer 0.5~5g/10min, fusing point are 50~75 DEG C, wherein maleic anhydride content is 0.3~1.5%, and density is 0.86~0.88g/ cm3。
Further, in the outer layer polyester elastomer melt flow index be 2~20g/10min, fusing point be 180~ 240 DEG C, density is 1.0~1.25g/cm3。
Preferably, the melt flow index of polyester elastomer is 3~15g/10min, fusing point in the outer layer It it is 190~220 DEG C, density is 1.1~1.2g/cm3。
Further, the overall thickness that the medical package easily takes off film is 70~200um, wherein thermal synthesis layer accounts for overall thickness 10~15%, structure sheaf accounts for the 60~80% of overall thickness, and adhesive layer accounts for the 5~10% of overall thickness, outer layer account for overall thickness 5~ 15%.
The preparation method of the present invention, includes the following steps：The raw material of thermal synthesis layer is placed in batch mixer first and is uniformly mixed, 3~6min of incorporation time, then the raw material of thermal synthesis layer, structure sheaf, adhesive layer, outer layer is sucked into extrusion respectively using suction feeder In machine hopper, cold up-draught, downward-blowing water-cooling and curtain coating co-extrusion production technology film forming are then used, film is placed on Co60 after winding Radiation chamber or high energy electron ray room in carry out crosslinking with radiation, finally use cutting machine to cut and to get medical package easily take off film.
Further, during the crosslinking with radiation, dose of radiation is 6~15Mrad, and gel content is 35~65%.
Preferably, during the crosslinking with radiation, dose of radiation be 8~12Mrad, gel content be 45~ 55%.
Further, the cutting machine using destaticed with ion wind, the cutting machine of negative pressure dust collector, cutting production ring Cleaning rank in border is A grades under C grades of backgrounds.
Compared with the prior art, the advantages of the present invention are as follows：
First, the present invention improves heat resistance using crosslinking with radiation technical finesse product, sterilising temp is up to 135 DEG C, no It is also easy to produce deformation, it is ensured that sterility requirements (F0＞ 12), polyethylene (PE) or its copolymer sterilising temp are solved not above 110 DEG C Problem greatly improves drug or medical device sterile guarantee value.
Second, material composition of the present invention is all inert medical macromolecular materials and is not susceptible to react with packing material, migrate Precipitate is few, and will not generate absorption to drug and lessen the curative effect, very convenient using rear recycling, if burning disposal When not will produce dioxin, environment is impacted minimum, reaches Packaging Reduce, energy-saving purpose, belong to environment-friendly products.
Third, the present invention uses polyethylene (PE), ethane-acetic acid ethyenyl ester (EVA) and ethylene-methyl acrylate (EMA) Blend as heat seal layer material there is the good transparency, flexibility, heat sealability high temperature hot pressing or high frequency two may be used Kind welding manner quickly seals, and sealing property is reliable and with easy taking off property.
Fourth, production process of the present invention is from raw pellets to film, crosslinking with radiation and cutting carry out in clean environment, Particle and other pollutions are avoided, ensure that the sanitation performance of product to greatest extent.
Fifth, crystallinity is low in each composition material of the present invention and water absorption rate is small, be not in white after high-temp steam sterilizing Change phenomenon, light transmittance is high, and mist degree is small, reduces treatment and drug safety risk.
Sixth, the present invention is used as structure sheaf using polyethylene (PE), low temperature resistant to reachable -35 DEG C, it is fully solved medical bag Dress easily takes off film sterilising temp (>=121 DEG C) and low temperature resistant (≤- 25 DEG C) cannot while mutually take into account problem.
Seventh, the present invention is used as outer layer using polyester elastomer (TPEE), solves nylon (PA) and go out in γ ray sterilization Existing membrane material surface browning, leachable increase and curling problem, and modified poly ester coiling-resistant is functional, and unsymmetric structure will not go out It now crimps, to keep packaging welding very smooth.
Description of the drawings
Fig. 1 is the production technological process of the present invention.
Specific implementation mode
Below in conjunction with specific embodiment, the present invention is described in further detail：
Embodiment 1：A kind of medical package easily takes off the raw material components (the equal percentage of physical measurement unit) of film：
(1) thermal synthesis layer：Polyethylene 30%, ethane-acetic acid ethyenyl ester 40%, ethylene-methyl acrylate 30%, the heat seal (190 DEG C, 2.16kg) of the melt flow index of polyethylene is 0.5g/10min in layer, and fusing point is 80~120 DEG C, and density is 0.89g/cm3；(190 DEG C, 2.16kg) of the melt flow index of ethane-acetic acid ethyenyl ester is 0.5g/ in the thermal synthesis layer 10min, wherein vinyl acetate content 5%；The melt flow index (190 of ethylene-methyl acrylate in the thermal synthesis layer DEG C, 2.16kg) it is 0.5g/10min, wherein methyl acrylate content 10%；
(2) structure sheaf：(190 DEG C, 2.16kg) of the melt flow index of polyethylene, the polyethylene is 0.3g/10min, is melted Point is 90 DEG C, density 0.89g/cm3；
(3) adhesive layer：Maleic anhydride modified ethylene octene copolymer, the maleic anhydride modified ethylene octene copolymer melt (190 DEG C, 2.16kg) of body flow index is 0.3g/10min, and fusing point is 45 DEG C, wherein maleic anhydride content 0.1%, density For 0.85g/cm3；
(4) outer layer：(190 DEG C, 2.16kg) of the melt flow index of polyester elastomer, the polyester elastomer is 2g/ 10min, fusing point are 180 DEG C, density 1.0g/cm3。
The overall thickness that above-mentioned medical package easily takes off film is 70um, wherein the thickness of thermal synthesis layer is 7um, the thickness of structure sheaf Thickness for 55um, adhesive layer is 4um, and the thickness of outer layer is 4um.
The preparation method of the present invention：
The raw material of thermal synthesis layer is placed in batch mixer first and is uniformly mixed, incorporation time 3min, then by thermal synthesis layer, structure Layer, adhesive layer, outer layer raw material sucked in extruder hopper respectively using suction feeder, then use up-draught it is cold, under blow Water cooling and curtain coating co-extrusion production technology film forming, after winding by film be placed on Co60 radiation chamber or high energy electron ray room in carry out Crosslinking with radiation, dose of radiation 15Mrad, gel content 35% finally use cutting machine cutting easily to be taken off to get medical package Film.
Embodiment 2：A kind of medical package easily takes off the raw material components (the equal percentage of physical measurement unit) of film：
(1) thermal synthesis layer：Polyethylene 80%, ethane-acetic acid ethyenyl ester 10%, ethylene-methyl acrylate 10%, the heat seal (190 DEG C, 2.16kg) of the melt flow index of polyethylene is 10g/10min in layer, and fusing point is 120 DEG C, density 0.94g/ cm3；(190 DEG C, 2.16kg) of the melt flow index of ethane-acetic acid ethyenyl ester is 5g/10min in the thermal synthesis layer, wherein second Vinyl acetate content is 30%；The melt flow index (190 DEG C, 2.16kg) of ethylene-methyl acrylate is in the thermal synthesis layer 10g/10min, wherein methyl acrylate content 35%；
(2) structure sheaf：(190 DEG C, 2.16kg) of the melt flow index of polyethylene, the polyethylene is 8g/10min, fusing point It is 125 DEG C, density 0.96g/cm3；
(3) adhesive layer：Maleic anhydride modified ethylene octene copolymer, the maleic anhydride modified ethylene octene copolymer melt (190 DEG C, 2.16kg) of body flow index is 10g/10min, and fusing point is 95 DEG C, wherein maleic anhydride content 3%, density are 0.90g/cm3；
(4) outer layer：(190 DEG C, 2.16kg) of the melt flow index of polyester elastomer, the polyester elastomer is 20g/ 10min, fusing point are 240 DEG C, density 1.25g/cm3。
The overall thickness that above-mentioned medical package easily takes off film is 100um, wherein the thickness of thermal synthesis layer is 15um, the thickness of structure sheaf Degree is 65um, and the thickness of adhesive layer is 10um, and the thickness of outer layer is 10um.
The preparation method of the present invention：
The raw material of thermal synthesis layer is placed in batch mixer first and is uniformly mixed, incorporation time 6min, then by thermal synthesis layer, structure Layer, adhesive layer, outer layer raw material sucked in extruder hopper respectively using suction feeder, then use up-draught it is cold, under blow Water cooling and curtain coating co-extrusion production technology film forming, after winding by film be placed on Co60 radiation chamber or high energy electron ray room in carry out Crosslinking with radiation, dose of radiation 6Mrad, gel content 65% finally use cutting machine cutting easily to be taken off to get medical package Film.
Embodiment 3：A kind of medical package easily takes off the raw material components (the equal percentage of physical measurement unit) of film：
(1) thermal synthesis layer：Polyethylene 50%, ethane-acetic acid ethyenyl ester 30%, ethylene-methyl acrylate 20%, the heat seal (190 DEG C, 2.16kg) of the melt flow index of polyethylene is 8g/10min in layer, and fusing point is 80~120 DEG C, density 0.9g/ cm3；(190 DEG C, 2.16kg) of the melt flow index of ethane-acetic acid ethyenyl ester is 3g/10min in the thermal synthesis layer, wherein second Vinyl acetate content is 20%；The melt flow index (190 DEG C, 2.16kg) of ethylene-methyl acrylate is in the thermal synthesis layer 5g/10min, wherein methyl acrylate content 20%；
(2) structure sheaf：(190 DEG C, 2.16kg) of the melt flow index of polyethylene, the polyethylene is 5g/10min, fusing point It is 100 DEG C, density 0.91g/cm3；
(3) adhesive layer：Maleic anhydride modified ethylene octene copolymer, the maleic anhydride modified ethylene octene copolymer melt (190 DEG C, 2.16kg) of body flow index is 5g/10min, and fusing point is 50 DEG C, wherein maleic anhydride content 2%, density are 0.88g/cm3；
(4) outer layer：(190 DEG C, 2.16kg) of the melt flow index of polyester elastomer, the polyester elastomer is 10g/ 10min, fusing point are 200 DEG C, density 1.1g/cm3。
The overall thickness that above-mentioned medical package easily takes off film is 150um, wherein the thickness of thermal synthesis layer is 20um, the thickness of structure sheaf Degree is 100um, and the thickness of adhesive layer is 8um, and the thickness of outer layer is 22um.
The preparation method of the present invention：
The raw material of thermal synthesis layer is placed in batch mixer first and is uniformly mixed, incorporation time 5min, then by thermal synthesis layer, structure Layer, adhesive layer, outer layer raw material sucked in extruder hopper respectively using suction feeder, then use up-draught it is cold, under blow Water cooling and curtain coating co-extrusion production technology film forming, after winding by film be placed on Co60 radiation chamber or high energy electron ray room in carry out Crosslinking with radiation, dose of radiation 12Mrad, gel content 40% finally use cutting machine cutting easily to be taken off to get medical package Film.
Embodiment 4：A kind of medical package easily takes off the raw material components (the equal percentage of physical measurement unit) of film：
(1) thermal synthesis layer：Polyethylene 70%, ethane-acetic acid ethyenyl ester 20%, ethylene-methyl acrylate 10%, the heat seal (190 DEG C, 2.16kg) of the melt flow index of polyethylene is 8g/10min in layer, and fusing point is 90 DEG C, density 0.89g/cm3； (190 DEG C, 2.16kg) of the melt flow index of ethane-acetic acid ethyenyl ester is 2g/10min in the thermal synthesis layer, wherein acetic acid second Enester content is 10%；(190 DEG C, 2.16kg) of the melt flow index of ethylene-methyl acrylate is 2g/ in the thermal synthesis layer 10min, wherein methyl acrylate content 30%；
(2) structure sheaf：(190 DEG C, 2.16kg) of the melt flow index of polyethylene, the polyethylene is 7g/10min, fusing point It is 110 DEG C, density 0.96g/cm3；
(3) adhesive layer：Maleic anhydride modified ethylene octene copolymer, the maleic anhydride modified ethylene octene copolymer melt (190 DEG C, 2.16kg) of body flow index is 9g/10min, and fusing point is 50 DEG C, wherein maleic anhydride content 2.5%, density are 0.90g/cm3；
(4) outer layer：(190 DEG C, 2.16kg) of the melt flow index of polyester elastomer, the polyester elastomer is 18g/ 10min, fusing point are 190 DEG C, density 1.2g/cm3。
The overall thickness that above-mentioned medical package easily takes off film is 180um, wherein the thickness of thermal synthesis layer is 24um, the thickness of structure sheaf Degree is 120um, and the thickness of adhesive layer is 18um, and the thickness of outer layer is 18um.
The preparation method of the present invention：
The raw material of thermal synthesis layer is placed in batch mixer first and is uniformly mixed, incorporation time 5min, then by thermal synthesis layer, structure Layer, adhesive layer, outer layer raw material sucked in extruder hopper respectively using suction feeder, then use up-draught it is cold, under blow Water cooling and curtain coating co-extrusion production technology film forming, after winding by film be placed on Co60 radiation chamber or high energy electron ray room in carry out Crosslinking with radiation, dose of radiation 8Mrad, gel content 45% finally use cutting machine cutting easily to be taken off to get medical package Film.
Embodiment 5：A kind of medical package easily takes off the raw material components (the equal percentage of physical measurement unit) of film：
(1) thermal synthesis layer：Polyethylene 60%, ethane-acetic acid ethyenyl ester 25%, ethylene-methyl acrylate 15%, the heat seal (190 DEG C, 2.16kg) of the melt flow index of polyethylene is 1g/10min in layer, and fusing point is 115 DEG C, density 0.93g/cm3； (190 DEG C, 2.16kg) of the melt flow index of ethane-acetic acid ethyenyl ester is 1g/10min in the thermal synthesis layer, wherein acetic acid second Enester content is 25%；(190 DEG C, 2.16kg) of the melt flow index of ethylene-methyl acrylate is 8g/ in the thermal synthesis layer 10min, wherein methyl acrylate content 30%；
(2) structure sheaf：(190 DEG C, 2.16kg) of the melt flow index of polyethylene, the polyethylene is 0.5g/10min, is melted Point is 95 DEG C, density 0.94g/cm3；
(3) adhesive layer：Maleic anhydride modified ethylene octene copolymer, the maleic anhydride modified ethylene octene copolymer melt (190 DEG C, 2.16kg) of body flow index is 0.5g/10min, and fusing point is 75 DEG C, wherein maleic anhydride content 1.5%, density For 0.88g/cm3；
(4) outer layer：(190 DEG C, 2.16kg) of the melt flow index of polyester elastomer, the polyester elastomer is 15g/ 10min, fusing point are 220 DEG C, density 1.2g/cm3。
The overall thickness that above-mentioned medical package easily takes off film is 200um, wherein the thickness of thermal synthesis layer is 30um, the thickness of structure sheaf Degree is 138um, and the thickness of adhesive layer is 12um, and the thickness of outer layer is 20um.
The preparation method of the present invention：
The raw material of thermal synthesis layer is placed in batch mixer first and is uniformly mixed, incorporation time 6min, then by thermal synthesis layer, structure Layer, adhesive layer, outer layer raw material sucked in extruder hopper respectively using suction feeder, then use up-draught it is cold, under blow Water cooling and curtain coating co-extrusion production technology film forming, after winding by film be placed on Co60 radiation chamber or high energy electron ray room in carry out Crosslinking with radiation, dose of radiation 10Mrad, gel content 55% finally use cutting machine cutting easily to be taken off to get medical package Film.
Embodiment 6：Effect example
1, reference《The packaging of final sterilization medical instrument》(GBT19633-2005)、《National Medical Packing Materials standard heat sealing strength Measuring method》(YBB00122003) inspection the various embodiments described above heat sealing strength, Heat seal conditions are：Pressure：0.2MPa, time：1s, Wherein embodiment 1 and the comparison of normal film inspection result is shown in Table 1, and unit is indicated with N/15mm.
1 heat sealing strength survey report of table
From above-mentioned table 1 it can be found that same heat-seal temperature, the heat sealing strength of embodiment are relatively small；Embodiment heat seal is strong Degree maximum is in 10N/15mm or so, even maximum value is also easy to open；Easily taking off 5~10N/15mm, embodiment institute Corresponding heat-seal temperature haves a wide reach, and this reduces the control requirements to heat-seal temperature and pressure when production, can make finished product Heat sealing quality is reliable and stable.
2, with pressure：0.2MPa, time：1s, heat-seal temperature：155 DEG C, polypropylene (PP) cup body material is experimental condition, The various embodiments described above and 135 DEG C of normal film, 12min high-temperature sterilizations are examined to test front and back heat sealing strength and open trace situation, Each inspection result comparison is shown in Table 2, and unit is indicated with N/15mm.
The front and back heat seal survey report of 2 high-temperature sterilization of table experiment
Under above-mentioned Heat seal conditions, heat sealing strength substantially remains in 8 before and after each embodiment high-temperature sterilization as can be found from Table 2 Between~10N/15mm, sterilizing is front and back without big variation, and it is appropriate to open intensity, facilitates unlatching.No matter before and after sterilizing, each reality is removed After applying example, observation easily takes off film and polypropylene (PP) cup body material face, and or not absciss layer without wire drawing, trace is not smooth, it was demonstrated that this is material layer Interior stripping, i.e. peeling layer and polypropylene (PP) cup body material sealing fastness it is good, to efficiently avoid leakage the problem of.
3, according to 88 ＞ of United States Pharmacopeia USP35 ＜,《National Medical Packing Materials standard》YBB00012003, YBB00032003 and YBB00052003 tests, and the various embodiments described above product bio-safety performance, wherein 3 inspection result of embodiment is examined to be shown in Table 3。
3 bio-safety performance survey report of table
Serial number Inspection project Standard provides Inspection result
1 General toxicity (0.9% sodium chloride injection) Toxic reaction must not occur Meet regulation
2 General toxicity (polyethylene glycol 400) Toxic reaction must not occur Meet regulation
3 General toxicity (ethyl alcohol：0.9% sodium chloride injection=1：20) Toxic reaction must not occur Meet regulation
4 General toxicity (vegetable oil) Toxic reaction must not occur Meet regulation
5 Intradermal stimulation (0.9% sodium chloride injection) Must not score 1.0 It scores and 0 meets regulation
6 Intradermal stimulation (polyethylene glycol 400) Must not score 1.0 It scores and 0 meets regulation
7 Intradermal stimulation (ethyl alcohol：0.9% sodium chloride injection=1：20) Must not score 1.0 It scores and 0 meets regulation
8 Intradermal stimulation (vegetable oil) Must not score 1.0 It scores and 0 meets regulation
9 Cytotoxicity 2 grades must not be crossed Meet regulation
10 Implantation Regulation should be met Meet regulation
11 Hemolytic test Hemolysis rate must not cross 5% 0.4%
12 Sensitization test (STT) Sensitivity response must not cross I degree Meet regulation
4, registration technology is declared to drug, medical device package material according to State Food and Drug Administration (SFDA) It is required that and 87 ＞ of United States Pharmacopeia USP35 ＜ test, examine the various embodiments described above product chemical property, wherein embodiment 4 examine It the results are shown in Table 4.
4 chemical property survey report of table
Serial number Inspection project Standard provides Inspection result
1 Nonvolatile matter residue ≤15mg 7mg
2 Residue on ignition ≤5mg 3mg
3 Heavy metal ≤1ppm ＜ 1ppm
4 Buffering capacity ≤10ml 2.5ml
5 Styrene-content ≤1ug/g It is not detected
5, present invention commission Bengbu FengYuan TuShan Pharmaceutical Co., Ltd has carried out drug compatibility experiment, is below embodiment 2 conclusion (of pressure testing)s.According to《Pharmacopoeia of People's Republic of China》Two annex of version in 2010, Ⅺ Ⅹ C medicine stability test guidelines With《Drug packing material and drug compatibility test direction principle》(YBB00142002) requirement in by exposure experiments to light, adds Speed experiment, long-term test results show easily to take off film and high density polyethylene (HDPE) (HDPE) bottle using medical package provided by the invention Body material packs a variety of drugs, places under difficult environmental conditions, and every Testing index is without significant change and meets regulation, card Bright medical package, which easily takes off film physics, chemistry, biology do not occur with drug, to react, and it is originally special that stable quality does not influence drug Property, meet drug compatibility test requirements document, specific test result is shown in Table 5 and table 6.
5 medical package of table is easily taken off film and is reported with pyrazinamide tablet compatibility test
6 medical package of table is easily taken off film and is reported with citric acid pentoxyverine piece compatibility test
6, the present invention entrusts Winner Industry (Shenzhen) Co., Ltd. to be sealed experiment respectively as packaging film, epiphragma, separately It takes common film, the high heat sealing strength film easily taken off with method operation, is that cup body material packs gauze (specification with polypropylene (PP)：10*10* 8) 121 DEG C, 30min high-temperature sterilizations, are carried out, puts above-mentioned sample respectively in the corrugated case of same size, is wrapped per case 100, Every layer of 60 case, amount to 480 casees, above-mentioned 6 kinds of samples are respectively placed in automobile and are transported for long-distance by totally 8 layers, and transport mileage is total About 3000Km.
Detection method：After transport, corrugated case is opened to and is taken out from outer packaging bag sample, whether range estimation has leakage Packet records bottom pour ladle number；Such as non-bottom pour ladle, test specimen is placed on omnipotent test-run a machine between two parallel plates, applies the interior of about 10KPa Pressure maintains 10S, has seen whether bottom pour ladle, and record bottom pour ladle number, 3 specific test result of embodiment is shown in Table 7.
7 bottom pour ladle test report of table
Test result shows：The package encapsulation of the present invention is suitable with high heat sealing strength film, and is better than commonly easily taking off film packet Dress.

Claims (4)

1. a kind of medical package easily takes off film, which is characterized in that it includes four-layer structure, is followed successively by from the inside to the outside：Thermal synthesis layer, structure Layer, adhesive layer, outer layer；Wherein, the thermal synthesis layer is by the polyethylene of medical grade, ethane-acetic acid ethyenyl ester and ethylene-acrylic acid first The hybrid resin of ester composition is constituted；The structure sheaf is made of the polyethylene of medical grade；The adhesive layer is by maleic anhydride modified Ethylene octene copolymer is constituted；The outer layer is made of polyester elastomer；
The raw material percentage of the thermal synthesis layer includes：Polyethylene 30~80%, ethane-acetic acid ethyenyl ester 10~ 40%, ethylene-methyl acrylate 10~30%；
The melt flow index of polyethylene is 0.5~10g/10min in the thermal synthesis layer, and fusing point is 80~120 DEG C, and density is 0.89~0.94g/cm3；The melt flow index of ethane-acetic acid ethyenyl ester is 0.5~5g/10min in the thermal synthesis layer, In, vinyl acetate content is 5~30%；In the thermal synthesis layer melt flow index of ethylene-methyl acrylate be 0.5~ 10g/10min, wherein methyl acrylate content is 10~35%；
The melt flow index of polyethylene is 0.3~8g/10min in the structure sheaf, and fusing point is 90~125 DEG C, and density is 0.89~0.96g/cm3；
The melt flow index of maleic anhydride modified ethylene octene copolymer is 0.3~10g/10min, fusing point in the adhesive layer It it is 45~95 DEG C, wherein maleic anhydride content is 0.1~3%, and density is 0.85~0.90g/cm3；
The melt flow index of polyester elastomer is 2~20g/10min in the outer layer, and fusing point is 180~240 DEG C, and density is 1.0~1.25g/cm3。
2. medical package according to claim 1 easily takes off film, which is characterized in that the medical package easily takes off the overall thickness of film For 70~200um, wherein thermal synthesis layer accounts for the 10~15% of overall thickness, and structure sheaf accounts for the 60~80% of overall thickness, and adhesive layer accounts for always The 5~10% of thickness, outer layer account for the 5~15% of overall thickness.
3. a kind of medical package easily takes off the preparation method of film, which is characterized in that include the following steps：First by the raw material of thermal synthesis layer It is placed in batch mixer and is uniformly mixed, 3~6min of incorporation time, then the raw material of thermal synthesis layer, structure sheaf, adhesive layer, outer layer is utilized Suction feeder sucks in extruder hopper respectively, wherein polyethylene, ethane-acetic acid ethyenyl of the thermal synthesis layer by medical grade The hybrid resin of ester and ethylene-methyl acrylate composition is constituted；The structure sheaf is made of the polyethylene of medical grade；The bonding Layer is made of maleic anhydride modified ethylene octene copolymer；The outer layer is made of polyester elastomer；
The raw material percentage of the thermal synthesis layer includes：Polyethylene 30~80%, ethane-acetic acid ethyenyl ester 10~ 40%, ethylene-methyl acrylate 10~30%；
The melt flow index of polyethylene is 0.5~10g/10min in the thermal synthesis layer, and fusing point is 80~120 DEG C, and density is 0.89~0.94g/cm3；The melt flow index of ethane-acetic acid ethyenyl ester is 0.5~5g/10min in the thermal synthesis layer, In, vinyl acetate content is 5~30%；In the thermal synthesis layer melt flow index of ethylene-methyl acrylate be 0.5~ 10g/10min, wherein methyl acrylate content is 10~35%；
The melt flow index of polyethylene is 0.3~8g/10min in the structure sheaf, and fusing point is 90~125 DEG C, and density is 0.89~0.96g/cm3；
The melt flow index of maleic anhydride modified ethylene octene copolymer is 0.3~10g/10min, fusing point in the adhesive layer It it is 45~95 DEG C, wherein maleic anhydride content is 0.1~3%, and density is 0.85~0.90g/cm3；
The melt flow index of polyester elastomer is 2~20g/10min in the outer layer, and fusing point is 180~240 DEG C, and density is 1.0~1.25g/cm3；
Then cold up-draught, downward-blowing water-cooling and curtain coating co-extrusion production technology film forming are used, film is placed on to the spoke of Co60 after winding According to crosslinking with radiation is carried out in room or high energy electron ray room, finally uses cutting machine to cut and easily take off film to get medical package；It is described During crosslinking with radiation, dose of radiation is 6~15Mrad, and gel content is 35~65%.
4. medical package according to claim 3 easily takes off the preparation method of film, which is characterized in that the cutting machine uses band Ion wind destatics, the cutting machine of negative pressure dust collector.
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