CN106273957A - A kind of peritoneal dialysis liquid bag co-extrusion film and preparation method thereof - Google Patents
A kind of peritoneal dialysis liquid bag co-extrusion film and preparation method thereof Download PDFInfo
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- CN106273957A CN106273957A CN201610628246.2A CN201610628246A CN106273957A CN 106273957 A CN106273957 A CN 106273957A CN 201610628246 A CN201610628246 A CN 201610628246A CN 106273957 A CN106273957 A CN 106273957A
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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
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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
- B32B27/30—Layered products comprising a layer of synthetic resin comprising vinyl (co)polymers; comprising acrylic (co)polymers
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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
- B32B27/32—Layered products comprising a layer of synthetic resin comprising polyolefins
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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
- B32B37/00—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding
- B32B37/12—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding characterised by using adhesives
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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
- B32B37/00—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding
- B32B37/14—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding characterised by the properties of the layers
- B32B37/15—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding characterised by the properties of the layers with at least one layer being manufactured and immediately laminated before reaching its stable state, e.g. in which a layer is extruded and laminated while in semi-molten state
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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
- 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
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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
- 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
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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
- B32B2307/00—Properties of the layers or laminate
- B32B2307/50—Properties of the layers or laminate having particular mechanical properties
- B32B2307/558—Impact strength, toughness
-
- 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
- B32B2307/70—Other properties
- B32B2307/724—Permeability to gases, adsorption
- B32B2307/7242—Non-permeable
- B32B2307/7246—Water vapor barrier
-
- 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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Abstract
The invention discloses a kind of peritoneal dialysis liquid bag co-extrusion film and preparation method thereof, this peritoneal dialysis liquid bag co-extrusion film includes the thermal synthesis layer A being arranged in order from the inside to the outside, interior adhesive layer B, structure sheaf C, outer adhesive layer D and outer layer E；The hybrid resin that the material of described thermal synthesis layer A is modified polypropene (PP) and POE (POE) forms, described interior adhesive layer B is ethylene vinyl acetate (EVA), structure sheaf C is polyethylene (PE), the hybrid resin that described outer adhesive layer D is ethylene vinyl acetate copolymer (EVA) and ethylene methyl acrylate copolymer (EMA) forms, described outer layer E is modified polypropene (PP).The present invention provides the peritoneal dialysis liquid bag co-extrusion film of a kind of excellent combination property, low cost of manufacture.
Description
Technical field
The present invention relates to medical packaging field of new, relate more specifically to a kind of peritoneal dialysis liquid bag co-extrusion film and
Preparation method.
Background technology
Peritoneal dialysis solution is initially single pouch package, has engendered " O-set " system and " the double bag of duplex " system, bag later
The updating of dress brings the incidence rate of peritonitis and is decreased obviously, and makes the survival rate of patients undergoing peritoneal dialysis be obviously prolonged, peritoneum
Dialysis patient quantity is also increasing year by year.Over more than ten years, the peritoneal dialysis solution of " the double bag of duplex " formula is easy to medical care people because it has
Member and patient operate, performance safety is reliable, advantageously reduce the advantages such as infection risk, it has also become clinical first-selected peritoneal dialysis solution
Packaging system.
At present at peritoneal dialysis solution production field, bag is divided into polrvinyl chloride (PVC) film and non-PVC co-extrusion infusion film two kinds
Material.The problem that polrvinyl chloride (PVC) film exists is mainly: (1) polrvinyl chloride (PVC) film is in process of production for changing its property
Di (2-ethylhexyl) phthalate (DEHP) plasticizer can be added, phthalic acid diethyl may be had during it uses own
Ester (DEHP) plasticizer dissolution, di (2-ethylhexyl) phthalate (DEHP) is a kind of harmful substance releasable estrogen,
Contact di (2-ethylhexyl) phthalate (DEHP) may cause Development of Reproductive System bad, serious harm health；(2) poly-
Vinyl chloride (PVC) raw material is in process of production for preventing resin from degrading, generally added with the stabilizer of the elements such as calcic, zinc, barium, this
A little metal ions likely migrate during dialysis solution uses, and enter human body, the healthy band to people with medicinal liquid or blood
Affect；(3) polrvinyl chloride (PVC) film heat resistance is poor, and 121 DEG C of high temperature sterilize caudacoria serious light transmittances of material albefaction are low, medical care people
Member people is difficult to argue whether medicinal liquid goes bad out by outward appearance, it is easy to cause malpractice.(4), alcohol-soluble medicine fat-soluble to some
Thing has a stronger adsorptivity, thus causes that prescriptions amount is inaccurate, curative effect reduces；(5) polrvinyl chloride (PVC) film is to oxygen
Very big with the transit dose of steam, the very poor thus packaging expiration date of drug of barrier is only 1 year；(6) polrvinyl chloride (PVC)
And hydrochloric acid can be formed after copolymer burning, and cause the injury of humans and animals respiratory tract and the erosion to building, easy during another burning
Produce dioxin and environment is produced far-reaching influence.
The problem that non-PVC co-extrusion infusion film exists is mainly: (1) material flexibility is bad, and bag filter goes out at high-temperature steam
Embrittlement occurs after bacterium, the phenomenon such as breakage, leakage easily occurs in actual application；(2) temperature adaptation scope is little, is weak to 135 DEG C of high temperature
Steam sterilization, low-temperature impact resistance is poor, and the biggest specification bag filter occurs the machines such as breakage, leakage during low-temperature transport
Rate is greatly improved；(3) heat-sealable way is single can only use high temperature hot pressing in welding.(4) internal layer does not have easily taking off property, is difficult to make "
The double bag of O-set " system and " duplex ".
Summary of the invention
For problems of the prior art, first purpose of the present invention is to provide a kind of excellent combination property
Peritoneal dialysis liquid bag co-extrusion film, it has, and preferable high temperature resistance, low temperature impact properties be strong, after sterilizing light transmittance change little,
Film material adds and need not man-hour add plasticizer and migration precipitation thing is few, low cost of manufacture, can be as liquid drug, medical apparatus and instruments etc.
Film for packaging.Second object of the present invention is to provide the preparation method of a kind of peritoneal dialysis liquid bag co-extrusion film.
The technical scheme is that a kind of peritoneal dialysis liquid bag co-extrusion film, including the heat being arranged in order from the inside to the outside
Close layer A, interior adhesive layer B, structure sheaf C, outer adhesive layer D and outer layer E；The material of described thermal synthesis layer A is modified polypropene (PP)
The hybrid resin formed with POE (POE), described interior adhesive layer B is ethane-acetic acid ethyenyl ester (EVA), described
Structure sheaf C is polyethylene (PE), and described outer adhesive layer D is ethene-vinyl acetate copolymer (EVA) and ethylene-methyl acrylate
The hybrid resin that copolymer (EMA) forms, described outer layer E is modified polypropene (PP).Described thermal synthesis layer A uses modified polypropene
(PP) and the hybrid resin material that forms of POE (POE), price is low, adhesion, can be made into multi-cavity bag, low-temperature resistance
Impact is strong, and radiation hardness cross-links, can be the most compatible with described interior adhesive layer B.Described interior adhesive layer B uses ethane-acetic acid ethyenyl
Ester (EVA) material, has the preferable compatibility with modified polypropene (PP) and polyethylene (PE), can strengthen the bonding force of interlayer,
And low-temperature impact performance is preferable, crosslinking with radiation efficiency is high, is suitable for Large Copacity flexible package punch, reduces broken bag rate.Described structure sheaf C
Using polyethylene (PE) material, if there being secondary carbon in the construction unit of polyolefin backbone, this polyolefin is cross-linking type, as poly-
Ethylene, if containing tertiary carbon atom in the construction unit of main chain, the most this structure is between cross-linking type and degradation-type, such as poly-third
Alkene, therefore selecting polyethylene is that agent structure is more conducive to crosslinking with radiation；Meanwhile, polyethylene brittle temperature about-60 DEG C, elastic modelling quantity and
Yield force is little, therefore the low temperature resistant embrittlement of co-extrusion film and shock resistance can be made good, polypropylene brittle temperature about-10 DEG C, elastic modelling quantity
Big with yield force, modifying agent elastomer brittle temperature about-30 DEG C, therefore the overall low temperature resistant embrittlement of modified polypropene and shock resistance
Poor.Described outer adhesive layer D uses ethene-vinyl acetate copolymer (EVA) and ethylene-methyl acrylate copolymer (EMA) group
The hybrid resin become, EVA and EMA mixture has more preferable processing stability, temperature range width than pure EVA, adds with high temperature outer layer E
Work is more mated.Described outer layer E uses modified polypropene (PP) material, and price is low, and light transmission rate is high, and high temperature resistant and block-water performance is relatively
Good, coefficient of friction is little, and owing to erecting chemical chain bridge after crosslinking with radiation between strand, physical and mechanical property improves, the most wear-resisting
Property, resistance to creep and resistance to dimensional stability improve, be suitable for outer layer protection.
In technique scheme, in described thermal synthesis layer A, described modified polypropene (PP) accounts for described thermal synthesis layer A gross weight
60～90%, described modified polypropene (PP) 230 DEG C, melt flow index under conditions of 2.16kPa be 3～8g/
10min, fusing point is 120～140 DEG C, and density is 0.87～0.91g/cm3；Described POE (POE) accounts for described heat
Closing the 10～40% of layer A gross weight, described POE (POE) is at 190 DEG C, melt flow under conditions of 2.16kPa
Dynamic index is 0.5～5g/10min, and density is 0.85～0.90g/cm3。
In technique scheme, in described interior adhesive layer B, described ethane-acetic acid ethyenyl ester (EVA) 190 DEG C,
Melt flow index under conditions of 2.16kPa is 0.5～8g/10min, and wherein, described vinyl acetate (VA) accounts for described second
Alkene-vinyl acetate (EVA) weight content is 5～30%.
In technique scheme, in described structure sheaf C, described polyethylene (PE) 190 DEG C, under conditions of 2.16kPa
Melt flow index is 0.5～10g/10min, fusing point 80～120 DEG C, and density is 0.85～0.92g/cm3。
In technique scheme, in described outer adhesive layer D, described ethane-acetic acid ethyenyl ester (EVA) accounts for described outer adhesive layer
The 45～55% of D gross weight, described ethane-acetic acid ethyenyl ester (EVA) 190 DEG C, melt flows under conditions of 2.16kPa refers to
Number is 3～8g/10min, and wherein, it is 5 that described vinyl acetate (VA) accounts for described ethane-acetic acid ethyenyl ester (EVA) weight content
～30%；Described ethylene-methyl acrylate copolymer (EMA) accounts for the 45～55% of described outer adhesive layer D gross weight, 190 DEG C,
Melt flow index under conditions of 2.16kPa is 3～8g/10min, and wherein, described methyl acrylate copolymer (MA) accounts for institute
Stating ethylene-methyl acrylate copolymer (EMA) weight content is 10～35%.
In technique scheme, in described outer layer E, described modified polypropene (PP) 230 DEG C, under conditions of 2.16kPa
Melt flow index be 0.5～10g/10min, fusing point 120～140 DEG C, density is 0.88～0.91g/cm3。
In technique scheme, the gross thickness of described peritoneal dialysis liquid bag co-extrusion film is 200～350um, wherein said
The thickness accounting of thermal synthesis layer A is 10～20%, and the thickness accounting of described interior adhesive layer B is 10～20%, the thickness of described structure sheaf C
Degree accounting be 50～60%, the thickness accounting of described outer adhesive layer D is 10～20%, the thickness accounting of described outer layer E be 10～
20%.
The preparation method of a kind of peritoneal dialysis liquid bag co-extrusion film as described above, comprises the following steps:
Step (1): first polypropylene (PP) and POE (POE) are mixed to form the first mixture；
Step (2): again ethylene-ethyl acetate copolymer (EVA) and ethylene-methyl acrylate copolymer (EMA) are mixed
Form the second mixture；
Step (3): the first mixture and the second mixture are passed sequentially through suction feeder and is drawn to the extruder material of correspondence
In bucket；
Step (4): use coextrusion film blowing or casting technique to carry out producing thus obtain film, described MODIFIED PP/POE blend
Forming thermal synthesis layer A, described ethylene-ethyl acetate copolymer (EVA) goes into interior adhesive layer B, and described polyethylene (PE) forms structure
Layer C, the described hybrid resin formed for ethylene-ethyl acetate copolymer (EVA) and ethylene-methyl acrylate copolymer (EMA)
Forming outer adhesive layer D, described modified polypropene (PP) forms outer layer E, and described thermal synthesis layer A, interior adhesive layer B, structure sheaf C, outer
Adhesive layer D and outer layer E is arranged in order；
Step (5): film in described step (4) is placed in the radiation chamber of Co60 or electron ray room and carries out crosslinking with radiation,
And radiation dose is 5～15Mard, gel content is 35～65%, thus forms a kind of peritoneal dialysis liquid bag co-extrusion film.
In technique scheme, described step (1), (2), (3) and (4) is all carried out in the production district that clean rank is C level,
The described blown film type of cooling uses up-draught cold or downward-blowing water-cooling technique, and the air cleaning rank in film bubble is A level.
The beneficial effects of the present invention is:
(1) the peritoneal dialysis liquid bag co-extrusion film of the present invention adds at film material and need not man-hour add plasticizer and migration precipitation
Thing is few, it is to avoid the potential hazard both produced human body；
(2) lower cost for material that inside and outside the peritoneal dialysis liquid bag co-extrusion film of the present invention, each layer uses, low cost of manufacture,
And be respectively provided with stronger low-temperature impact resistance, have stronger crosslinking with radiation, can be prevented effectively from transportation damaged and
The phenomenon of leakage；Being respectively provided with the preferable compatibility between layers, bonding force is strong, and crosslinking with radiation efficiency is high, and broken bag rate is low, is more suitable for
In Large Copacity flexible package punch
(3) peritoneal dialysis liquid bag of present invention co-extrusion film innermost layer uses modified polypropene (PP) and ethylene octene copolymerization
The hybrid resin that thing (POE) forms, this material adhesion, multi-cavity bag can be made.
(4) the peritoneal dialysis liquid bag co-extrusion film of the present invention time internal layer uses the polyethylene that brittle temperature is relatively low, has preferably
Low temperature resistant brittle performance, and this elasticity modulus of materials and yield force little, shock resistance is strong.
(5) peritoneal dialysis liquid bag of present invention co-extrusion film outer layer uses modified polypropene (PP), this material heat-resisting quantity
Can be strong, can be with resistance to 115～135 DEG C of high-temp steam sterilizings, after sterilizing, light transmittance change is little, it is simple to medical worker is recognized by outward appearance
The deterioration of medicine；And block-water performance is preferable, effective blocking oxygen and the transit dose of steam, dialysis solution is had preferably
Protectiveness, reduces medicine and rotten probability occurs, increase the shelf-life of medicine, ensure the drug safety of patient；Coefficient of friction is low,
Wearability is strong, as outer protective layer, can improve the service life of film bag.
Accompanying drawing explanation
Fig. 1 show the structural representation of a kind of peritoneal dialysis liquid bag co-extrusion film of the present invention.
Detailed description of the invention
Describing the present invention below in conjunction with the accompanying drawings, the description of this part is only exemplary and explanatory, should not
Protection scope of the present invention is had any restriction effect.In conjunction with figure below, the invention will be further described.
As it is shown in figure 1, a kind of peritoneal dialysis liquid bag co-extrusion film that the present invention provides, including be arranged in order from the inside to the outside
Thermal synthesis layer A, interior adhesive layer B, structure sheaf C, outer adhesive layer D and outer layer E；The material of thermal synthesis layer A be modified polypropene (PP) and
The hybrid resin that POE (POE) forms, interior adhesive layer B be ethane-acetic acid ethyenyl ester (EVA), structure sheaf C be poly-
Ethylene (PE), outer adhesive layer D is ethene-vinyl acetate copolymer (EVA) and ethylene-methyl acrylate copolymer (EMA) composition
Hybrid resin, outer layer E is modified polypropene (PP).
In thermal synthesis layer A, modified polypropene (PP) accounts for the 60～90% of described thermal synthesis layer A gross weight, modified polypropene (PP)
230 DEG C, melt flow index under conditions of 2.16kPa be 3～8g/10min, fusing point is 120～140 DEG C, and density is
0.87～0.91g/cm3；POE (POE) accounts for the 10～40% of described thermal synthesis layer A gross weight, ethylene octene copolymerization
Thing (POE) 190 DEG C, melt flow index under conditions of 2.16kPa be 0.5～5g/10min, density be 0.85～
0.90g/cm3。
In interior adhesive layer B, ethane-acetic acid ethyenyl ester (EVA) is 190 DEG C, melt flow index under conditions of 2.16kPa
Being 0.5～8g/10min, wherein, it is 5～30% that vinyl acetate (VA) accounts for ethane-acetic acid ethyenyl ester (EVA) weight content.
In structure sheaf C, polyethylene (PE) 190 DEG C, melt flow index under conditions of 2.16kPa be 0.5～10g/
10min, fusing point 80～120 DEG C, density is 0.85～0.92g/cm3。
In outer adhesive layer D, ethane-acetic acid ethyenyl ester (EVA) accounts for the 45～55% of described outer adhesive layer D gross weight, and ethylene-
Vinyl acetate (EVA) 190 DEG C, melt flow index under conditions of 2.16kPa be 3～8g/10min, wherein, acetic acid second
It is 5～30% that alkene ester (VA) accounts for described ethane-acetic acid ethyenyl ester (EVA) weight content；Ethylene-methyl acrylate copolymer
(EMA) account for the 45～55% of described outer adhesive layer D gross weight, 190 DEG C, melt flow index under conditions of 2.16kPa be 3
～8g/10min, wherein, methyl acrylate copolymer (MA) accounts for described ethylene-methyl acrylate copolymer (EMA) weight content
It is 10～35%.
In outer layer E, modified polypropene (PP) 230 DEG C, melt flow index under conditions of 2.16kPa be 0.5～
10g/10min, fusing point 120～140 DEG C, density is 0.88～0.91g/cm3。
The gross thickness of peritoneal dialysis liquid bag co-extrusion film is 200～350 μm, wherein the thickness accounting of thermal synthesis layer A be 10～
20%, the thickness accounting of interior adhesive layer B is 10～20%, and the thickness accounting of structure sheaf C is 50～60%, the thickness of outer adhesive layer D
Degree accounting is 10～20%, and the thickness accounting of outer layer E is 10～20%.
The preparation method of a kind of peritoneal dialysis liquid bag co-extrusion film as described above, comprises the following steps:
Step (1): first by polypropylene (PP) and POE (POE) mixing and stirring, forms the first mixing
Thing；
Step (2): again ethylene-ethyl acetate copolymer (EVA) and ethylene-methyl acrylate copolymer (EMA) are mixed
Stir, form the second mixture；
Step (3): the first mixture and the second mixture are passed sequentially through suction feeder and is drawn to the extruder material of correspondence
In bucket；When utilizing suction feeder that each raw material is sucked use automatic Weighing suction system, so, each raw material be inhaled into and
That extrudes measures control, and then can control the thickness that each layer raw material ultimately forms.
Step (4): using coextrusion film blowing or casting technique to carry out producing thus obtain film, MODIFIED PP/POE blend is formed
Thermal synthesis layer A, ethylene-ethyl acetate copolymer (EVA) goes into interior adhesive layer B, and polyethylene (PE) forms structure sheaf C, for ethylene-second
The hybrid resin that acetoacetic ester copolymer (EVA) and ethylene-methyl acrylate copolymer (EMA) form forms outer adhesive layer D, modified
Polypropylene (PP) forms outer layer E, and thermal synthesis layer A, interior adhesive layer B, structure sheaf C, outer adhesive layer D and outer layer E are arranged in order；Blow
In membrane process, the type of cooling uses up-draught cold or downward-blowing water-cooling technique, and the air cleaning rank in film bubble is A level.
Step (5): film in step (4) is placed in the radiation chamber of Co60 or electron ray room and carries out crosslinking with radiation, and spoke
Penetrating dosage is 5～15Mard, and gel content is 35～65%, thus forms a kind of peritoneal dialysis liquid bag co-extrusion film.
In technique scheme, step (1), (2), (3) and (4) is all carried out in the production district that clean rank is C level.
The situation of being embodied as is shown in Tables 1 and 2:
Table 1 is the weight content proportioning of each material
Table 2 is the thickness of embodiment 1～5 film and each layer thickness proportioning and film-forming process condition
Above-mentioned each enforcement is checked with reference to " country's Medical Packing Materials calibrating gas transit dose algoscopy " (YBB00082003-2015)
The oxygen transit dose of example and nitrogen transit dose, carried out polrvinyl chloride (PVC) film and ethane-acetic acid ethyenyl ester (EVA) film simultaneously
Test, assay contrast is shown in Table 3.
The oxygen transit dose of table 3 embodiment 1～5 and the detection of nitrogen transit dose
From above-mentioned table 3 it appeared that the gas permeation amount of each embodiment is relatively small, compared with PVC and EVA film when long
In infusion process, the protectiveness to treatment and nutrition infusion is more preferable, reduces medicine and rotten probability occurs, ensure the medication of patient
Safety.
Examine with reference to " country's Medical Packing Materials standard " multilayer co-squeeze film for transfusion, bag general rule (YBB00342002-2015)
Testing, check the various embodiments described above product physical property, wherein embodiment 1 assay is shown in Table 4.
Table 4 physical property survey report
Liquid bearingtest: the peritoneal dialysis liquid bag that various dose Dextrose and Sodium Chloride Inj. injects the present invention is used
In the transfusion bag that co-extrusion film is made, and hanging placement 48 hours, wherein embodiment 2 is the result of the test such as table 5 of sample.
Table 5 peritoneal dialysis liquid bag of the present invention co-extrusion film liquid load-carrying properties are checked
Low temperature brittleness and low-temperature impact performance detection: the peritoneal dialysis liquid bag co-extrusion film of the present invention is placed in Different hypothermia
Under environment, after placing 12 hours, softly feel brittle performance with hands,
And up and down cross directional stretch product, the wherein such as table 6 of the result of the test with embodiment 3 as sample.
Table 6 peritoneal dialysis liquid bag of the present invention co-extrusion film low temperature brittleness performance detects
As can be seen from Table 6, the peritoneal dialysis liquid bag of present invention co-extrusion film becomes without obvious about-50 DEG C physical propertys
Change, there is preferable low temperature brittleness and low-temperature impact performance.
The peritoneal dialysis liquid bag co-extrusion film of the present invention is carried out light transmittance detection after high-temp steam sterilizing, such as table 7.
The peritoneal dialysis liquid bag of table 7 present invention co-extrusion film high-temp. sterilizing light transmittance detects
| Sequence number | 1 | 2 | 3 | 4 | 5 |
| Temperature | 100℃ | 115℃ | 120℃ | 130℃ | 135℃ |
| Transparency | Transparent bright and clean | Transparent bright and clean | Transparent visible | Transparent visible | Transparent visible |
As can be seen from Table 7, the peritoneal dialysis liquid bag co-extrusion film of the present invention carries out light transmittance after high-temp steam sterilizing
Change less, it is simple to medical worker is by the deterioration of outward appearance identification medicine.
The product of embodiment 1～5 is shown through exposure experiments to light, accelerated test, long-term test results, uses the present invention's
The peritoneal dialysis liquid bag co-extrusion multiple medicine of film bag-making loading, places under difficult environmental conditions, and every Testing index is without substantially
Change and all meet regulation, it was demonstrated that peritoneal dialysis liquid bag co-extrusion film and medicine do not occur physics, chemistry, biological reaction, matter
Amount is stable does not affect the original characteristic of medicine, meets drug compatibility test requirements document.
It is divided into tetra-grades of A, B, C, D by " Good Manufacturing Practice and Quality Control of Drug " regulation about cleaniliness classs, is shown in Table
8。
Table 8 cleaniliness classs divides tetra-grades of A, B, C, D
The above, be only presently preferred embodiments of the present invention, and not the technical scope to the present invention makes any limit
System, therefore every any trickle amendment, equivalent variations and modification above example made according to the technical spirit of the present invention, all
In the range of still falling within technical scheme.
Claims (9)
1. a peritoneal dialysis liquid bag co-extrusion film, it is characterised in that: the thermal synthesis layer A that includes being arranged in order from the inside to the outside, interior viscous
Close layer B, structure sheaf C, outer adhesive layer D and outer layer E；The material of described thermal synthesis layer A is modified polypropene (PP) and ethylene octene
The hybrid resin that copolymer (POE) forms, described interior adhesive layer B be ethane-acetic acid ethyenyl ester (EVA), structure sheaf C be polyethylene
(PE), described outer adhesive layer D is ethene-vinyl acetate copolymer (EVA) and ethylene-methyl acrylate copolymer (EMA) composition
Hybrid resin, described outer layer E is modified polypropene (PP).
2. peritoneal dialysis liquid bag co-extrusion film as claimed in claim 1, it is characterised in that: in described thermal synthesis layer A, described modification
Polypropylene (PP) accounts for the 60～90% of described thermal synthesis layer A gross weight, and described modified polypropene (PP) is at 230 DEG C, the bar of 2.16kPa
Melt flow index under part is 3～8g/10min, and fusing point is 120～140 DEG C, and density is 0.87～0.91g/cm3；Described second
Alkene octene copolymer (POE) accounts for the 10～40% of described thermal synthesis layer A gross weight, and described POE (POE) is 190
DEG C, melt flow index under conditions of 2.16kPa be 0.5～5g/10min, density is 0.85～0.90g/cm3。
3. peritoneal dialysis liquid bag co-extrusion film as claimed in claim 1, it is characterised in that: in described interior adhesive layer B, described second
Alkene-vinyl acetate (EVA) 190 DEG C, melt flow index under conditions of 2.16kPa be 0.5～8g/10min, wherein,
It is 5～30% that described vinyl acetate (VA) accounts for described ethane-acetic acid ethyenyl ester (EVA) weight content.
4. peritoneal dialysis liquid bag co-extrusion film as claimed in claim 1, it is characterised in that: in described structure sheaf C, described poly-second
Alkene (PE) 190 DEG C, melt flow index under conditions of 2.16kPa be 0.5～10g/10min, fusing point 80～120 DEG C, close
Degree is 0.85～0.92g/cm3。
5. peritoneal dialysis liquid bag co-extrusion film as claimed in claim 1, it is characterised in that: in described outer adhesive layer D, described second
Alkene-vinyl acetate (EVA) accounts for the 45～55% of described outer layer D gross weight, and described ethane-acetic acid ethyenyl ester (EVA) is 190
DEG C, melt flow index under conditions of 2.16kPa be 3～8g/10min, wherein, described vinyl acetate (VA) accounts for described second
Alkene-vinyl acetate (EVA) weight content is 5～30%；Described ethylene-methyl acrylate copolymer (EMA) accounts for outside described time
The 45～55% of layer D gross weight, 190 DEG C, melt flow index under conditions of 2.16kPa be 3～8g/10min, wherein,
It is 10～35% that described methyl acrylate copolymer (MA) accounts for described ethylene-methyl acrylate copolymer (EMA) weight content.
6. peritoneal dialysis liquid bag co-extrusion film as claimed in claim 1, it is characterised in that: in described outer layer E, described modification gathers
Propylene (PP) 230 DEG C, melt flow index under conditions of 2.16kPa be 0.5～10g/10min, fusing point 120～140 DEG C,
Density is 0.88～0.91g/cm3。
7. peritoneal dialysis liquid bag co-extrusion film as claimed in claim 1, it is characterised in that: described peritoneal dialysis liquid bag co-extrusion
The gross thickness of film is 200～350 μm, and the thickness accounting of wherein said thermal synthesis layer A is 10～20%, the thickness of described interior adhesive layer B
Degree accounting is 10～20%, and the thickness accounting of described structure sheaf C is 50～60%, and the thickness accounting of described outer adhesive layer D is 10
～20%, the thickness accounting of described outer layer E is 10～20%.
8. the preparation method of co-extrusion film of the peritoneal dialysis liquid bag as described in claim 1～7, it is characterised in that: include
Following steps:
Step (1): first polypropylene (PP) and POE (POE) are mixed to form the first mixture；
Step (2): again ethylene-ethyl acetate copolymer (EVA) and ethylene-methyl acrylate copolymer (EMA) are mixed to form
Second mixture；
Step (3): the first mixture and the second mixture are passed sequentially through in the extruder hopper that suction feeder is drawn to correspondence；
Step (4): using coextrusion film blowing or casting technique to carry out producing thus obtain film, described MODIFIED PP/POE blend is formed
Thermal synthesis layer A, described ethylene-ethyl acetate copolymer (EVA) goes into interior adhesive layer B, and described polyethylene (PE) forms structure sheaf C,
The described hybrid resin formation formed for ethylene-ethyl acetate copolymer (EVA) and ethylene-methyl acrylate copolymer (EMA)
Outer adhesive layer D, described modified polypropene (PP) forms outer layer E, and described thermal synthesis layer A, interior adhesive layer B, structure sheaf C, outer bonding
Layer D and outer layer E is arranged in order；
Step (5): described film is placed in the radiation chamber of Co60 or electron ray room and carries out crosslinking with radiation, and radiation dose is 5
～15Mard, gel content is 35～65%, thus forms a kind of peritoneal dialysis liquid bag co-extrusion film.
9. the peritoneal dialysis liquid bag preparation method of co-extrusion film as claimed in claim 8, it is characterised in that: described step (1),
(2), (3) and (4) all carry out in the production district that clean rank is C level, the described blown film type of cooling use up-draught cold or under blow
Air cleaning rank in water-cooling process, and film bubble is A level.
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| CN106273957B (en) | 2019-02-01 |
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