CN1663775A - Multilayer co-extrusion transfusion film and manufacturing method thereof - Google Patents
Multilayer co-extrusion transfusion film and manufacturing method thereof Download PDFInfo
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- CN1663775A CN1663775A CN 200510049011 CN200510049011A CN1663775A CN 1663775 A CN1663775 A CN 1663775A CN 200510049011 CN200510049011 CN 200510049011 CN 200510049011 A CN200510049011 A CN 200510049011A CN 1663775 A CN1663775 A CN 1663775A
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- Medical Preparation Storing Or Oral Administration Devices (AREA)
Abstract
The invention discloses a multi-layer common squeeze transfusion film and its manufacturing method. It has five layers structure, the first layer is the heat sealing inner layer A, which is the mixing resin composed of PP and SEBS hot plastic elastic polymers; the second layer is the adhering layer B, which is propene-ethylene polymers; the third layer is the core layer, which is the propene-ethylene/a-olefin elastomer; the fourth layer is the adhering layer D, which is the ethylene methyl acrylic resin polymers; the fifth layer is the wearable layer, which is the elastic resin PTMT. The manufacturing method is to implement high-energetic electronic radiation treatment to the multi-layer film so as to improve the heat-fast capability and the transparent degree of the products.
Description
Technical field
The present invention relates to PP TYPE and manufacture method thereof that a kind of macromolecular material is made, more particularly, relate to the Multi-layer Laminated Infusion Membrane And Manufacturing Approach of pharmaceutical pack material such as conduct transfusion or blood in medical field.
Background technology
The packing material of similar medical supplies such as transfusion of more generally using or blood was a flexible PVC in the past, because it needs to add various auxiliary agents to improve its performance in process, and the migration of little molecule auxiliary agent and polyvinyl chloride self with the chlorine element make flexible PVC from being worked into removal process, all can discharge the composition that health is had harm.Be guarantee people drug safety, and according to environmental protection requirement, the medicine of China and countries in the world prison department has worked out exigent quality standard to directly contacting pharmaceutical pack materials such as soup or blood at present, flexible PVC can not satisfy its requirement.
Based on this, people are just adopting the combination of various new materials or material in active research, to satisfy the many-sided multi-level strict demand on performance of this based packaging material.Because the film material of single composition is difficult to satisfy the composite request of its each side, thereby present way with double advantage of getting various monofilms, remedies the deficiency of monofilm normally the in addition optimum organization and make PP TYPE of the monofilm of several each tool characteristic.Consult now disclosed patent, disclosed material in these disclosed materials such as Chinese patent ZL99814444.4 and the Chinese patent application 01111112.7, truly have certain advance at that time, but along with the raising of the people to the medicine packing instructions, and the Application and Development of various high performance plastics resins, these patented technologies obviously can't adapt to and satisfy needs of society.Such as: application number is 0111112.7 Chinese patent application employing polyamide, barrier property and hot strength are fine really, upward machine is on probation but it is in the canning line in pharmaceutical factory, a lot of filaments are arranged in the time of can finding to cut off, adjusting process is not got rid of this phenomenon yet, this is a unconquerable always for many years difficult problem, because transfusion is to want in the intravasation, the invisible particulate of naked eyes will cause life danger, does not come contaminated environment so do not allow this fiber fines silk in the toilet of medicine can.Moreover, the good multi-layer film material of excellent performance should have good comprehensive performances, comprise and have good physical property, good seal performance, particulate oozes out low, transparency is good, flexibility reaches 121 ℃ of high temperature and high pressure steam sterilizations of ability etc. well, and meet required chemical-resistant stability energy of medicinal fluid packaging material and biology, sanitary index, investigate from these indexs, the combination property of existing multi-layer film material is still waiting further raising, especially the overall balance of flexibility, temperature tolerance and the transparency with improve on remain further to be promoted.
In addition, the production technology of multilayer film material also can not be ignored effect of material performance.What prior art mostly adopted is the traditional handicraft of downward-blowing water-cooling, must not say that extruder will be placed on what have bother on the equipment high more than 6 meters, and several tons of material are brought up also gruelling every day during batch process.More crucial is that the sanitary index that a present insurmountable difficult problem is a downward-blowing water-cooling does not reach the national standard requirement.Microorganism is easy at constant temperature as everybody knows, and have a growth reproduction in moisture and the moist environment, so this microbial limit control is bad, sanitary index can't pass through, blow infusion production line under several the water-cooleds of present domestic introduction, so far all can't produce in batches, the unacceptable product theory in pharmaceutical factory is good also useless again.
The present invention through test for many years, progressively improves and has drawn and used the advantage of new exclusive resin in the world just under such background, be optimized combination and obtain have the good physical property and a multi-layer film material of sanitary index.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of good combination property at above-mentioned prior art present situation, especially sealing property, anti-particulate ooze out the good novel multi-layer co-extrusion infusion film of performance, transparency, flexibility and temperature tolerance, and the manufacture method of this multi-layer co-extrusion infusion film.
The present invention solves the problems of the technologies described above the technical scheme that is adopted: this kind multi-layer co-extrusion infusion film, be seen as five-layer structure from the material composition, and it is characterized in that:
Ground floor is envelope internal layer A, its composition is the hybrid resin that polypropylene and SEBS thermoplastic elastomer copolymer form, SEBS refers to styrene-ethylene-butene rubber-styrene block copolymer, and the addition of SEBS thermoplastic elastomer copolymer in hybrid resin is 40-60wt%; The melt index of the hybrid resin that used polypropylene and SEBS thermoplastic elastomer copolymer form among the heat-sealing internal layer A is 2.0～15g/10min, and density is 0.89～0.9g/cm
3This layer thickness is 20～45 μ m, accounts for 15～25% of multi-layer co-extrusion infusion film gross thickness.
The SEBS elastomer is styrene-ethylene-butene rubber-styrene block copolymer, because the malleable of butene rubber is good especially, so not only finished product flexibility and toughness are splendid, the low-temperature heat-sealing performance is also fine.SEBS is used in internal layer and also has self-adhesion, in the film bubble, blow with 100 grades of aseptic ultra-purify airs, after the folder rod flattens, can make two tunics under the state of self-adhesion closure, cut packing all the time, stop other air pollution of extraneous low purification level, thereby the internal layer that has guaranteed direct contact soup have good health and Biological indicators.Through the drug compatibility evidence, its chemical-resistant stability can be good especially, has drug compatibility widely, and liquid drug is after the particulate instrument detects proof in 6 months accelerated test, exudate and particle number are few, reach fully and have surpassed America and Europe and national standard.
The second layer is adhesive linkage B, and its composition is a propylene-ethylene copolymers, and melt index is 1.5～5g/10min, and density is 0.89～0.9g/cm
3This layer thickness is 15～26 μ m, accounts for 8～15% of multi-layer co-extrusion infusion film gross thickness.This layer effect is that ground floor A and the 3rd layer of C raw material are had good adhesion strength, make them no matter be cryopreservation, or high-temperature sterilization combines all the time.
The 3rd layer is core layer C, and its composition is propylene-ethylene/a-olefin-copolymerization elastomer, and melt index is 1～5g/10min, and density is 0.89～0.92g/cm
3This layer thickness is 50～80 μ m, accounts for 30～45% of multi-layer co-extrusion infusion film gross thickness.This layer characteristic are that pliability is good especially, can be shock-resistant and crooked, and transparency and endurable thorn are splendid, still can keep good toughness at low temperatures, and drawdown intensity and mechanical property are good, are the main materials that can guarantee by 2.5 meters drop tests.
The 4th layer is bonding layer D, and its composition is the ethylene methacrylate polymer, and melt index is 1.5～5g/10min, and density is 0.9～0.93g/cm
3This layer thickness is 15～25 μ m, accounts for 8～14% of multi-layer co-extrusion infusion film gross thickness.This layer quality softness, cold and hot good stability has good bonding fastness to the 3rd layer of C and layer 5 E raw material.
Layer 5 is weathering layer E, and its composition is the elastic resin PETG, and melt index is 4～10g/10min, and density is 1.1～1.3g/cm
3This layer thickness is 18～36 μ m, accounts for 10～20% of multi-layer co-extrusion infusion film gross thickness.Polyester has good barrier performance and impact strength, and transparency is good, and is tough wear-resisting, and cold and hot stability is good, can not be out of shape when high temperature heat-sealing and high temperature sterilization, and with good physical property, guarantee outer field scratch-resistant performance and printing fastness.
As everyone knows, the melting temperature of polyester is 225-260 ℃, the melting temperature of propylene is 164-172 ℃, the melting temperature of ethene is 125-128 ℃, with polyester as skin, can utilize its resistance to elevated temperatures, solved the difficulty that so-called symmetrical structure in a lot of patents (being that ectonexine is all with propylene or ethene) can be run into when the heat-sealing bag of practical application, as outermost resin melt temperature and the much the same words of internal layer, temperature is low boiling hot at all not firm during heat seal, and when cementing as temperature being heightened the fusion of inner layer resin energy, outermost resin contact earlier scalds mould, be out of shape because of being unable to undergo long high temperature, even break, although temperature, time, pressure is finely tuned very carefully, because the thickness of infusion film is big, always the film of sensation outside is molten soon broken, and the heat-seal temperature that is delivered to internal layer not enough.The flatness of thermal synthesis bag is bad certainly like this, and substandard products ratios such as bottom pour ladle are also very high.
We analyze and research in a large amount of production practices, conclusion is that internal layer A resin is when standing the sterilization in 30 minutes of high temperature 121 degree, should select the melting temperature low resin of should trying one's best for use, we creatively add SEBS, just in time satisfied the requirement of this respect, skin must be selected the high temperature resistant polyester of energy for use simultaneously, could guarantee the effect of thermoprint literal on bag quality and the infusion bag, broadness along with exospheric temperature accommodation, the just sure bag speed that improves, when guaranteeing internal layer heat-sealing effect, also improved production efficiency.
Polyester not only transparency and light transmittance is good, good barrier performance and hot strength are also arranged, the oxygen transit dose of polyester lacks more than 25 times than polypropylene, lack more than 50 times than polyethylene, Here it is used polyester after, hot strength and oxygen flow, physical property such as saturating wet significantly improve, and the thickness of infusion film has reduced, also one of sure reason that is up to state standards.
The gross thickness of described multi-layer co-extrusion infusion film is 150～190 μ m.
Existing its good one side of any material, also exist simultaneously deficiency and defective, the purpose of exploitation five-layer coextrusion transfusion film is double advantage of getting various resins, remedy the deficiency in the single film, the propylene resistance to elevated temperatures is better than ethene, but pliability is not as ethene, for guaranteeing the flexibility of infusion film, guarantee that packed transfusion can flatten fully, can have ethene in the prescription, but after adding ethene, may there be following problem in it: transparency is fine during blown film, but when co-extrusion gained multilayer film behind 30 minutes high temperature sterilizations of 121 degree, may cause from phenomenon owing to being unable to undergo high temperature, cause transparency decline, for solving this difficult problem, guarantee that blushing does not appear in multilayer film behind high temperature sterilization, we find that through for many years repetition test research the film resistance to elevated temperatures after high-energy electron irradiation is crosslinked significantly improves.With same material and same process blowing multireel multilayer film, wherein a volume adopts the cross-linking radiation new technology to be handled, contrast is found, through that volume multilayer film of irradiation crosslinking technological processing, because under effect of irradiation, make polyolefin produce a series of C-C key, and forming molecule crosslinked structure, the result should roll up the product heat-resisting ability and increase substantially, behind 30 minutes high-temperature sterilizations of 121 degree, transparency and flexibility remain unchanged, and pliability and tearing strength significantly improve; The transmitance of empty G﹠W in film descends; The optical physics performance is more outstanding.Certainly, this degree with cross-linking radiation is relevant, all can influence last result if the irradiation degree is not enough or excessive.Therefore, the method of making this multi-layer co-extrusion infusion film among the present invention is: it adopts up-draught cold type coextrusion process, it is characterized in that in the co-extrusion traction, adopt high-energy electron irradiation or X ray to carry out radiation to co-extrusion gained multilayer film, auxilliary is that 2-8 million draws the spy according to intensity, the auxilliary time of shining can be adjusted according to speed of production and absorption intensity, is generally 10～40 minutes.
In addition, shortcoming at existing downward-blowing water-cooling technology, our five-layer co-squeezing production line adopts the cold coextrusion process of up-draught, cooling air is up blown by following, not have the outer water that drips in the dust proof workshop, and the cooling air of film is that the freezing liquid of usefulness refrigeration machine is through the fan coil circularly cooling, the cold wind that blown film is used is 100 grades of pure airs that filter through multi-stage, efficient, whole infusion film production is at 10000 grades, and local 100 grades clean environment is produced down, and dust and microbiological indicator see following table for details:
Toilet (district) air purity rank table
| Cleanliness class | Dust maximum allowable number/cubic meter | The microorganism maximum allowable number | Rate of ventilation | ||
| ????≥0.5um | ????≥5um | Bacterium/cubic meter swims | Sedimentation bacterium/ware | ||
| ??100 | ??3500 | ??0 | ????5 | ????1 | Vertical laminar flow 〉=0.3 meter per second horizontal laminar flow 〉=0.4 meter per second |
| ??10000 | ??350000 | ??2000 | ????100 | ????3 | 〉=20 times/time |
| ??100000 | ??3500000 | ??20000 | ????500 | ????10 | 〉=15 times/time |
| ??3000000 | ??10500000 | ??60000 | ????- | ????15 | 〉=12 times/time |
Select from State Food and Drug Administration's 13 commands
Compared with prior art, the invention has the advantages that:
1, internal layer has the self-adhesion performance, and in rolling, to cut packing airtight all the time when dispatching from the factory, sanitation performance is good, and particle number is extremely low, and exudate is few.
2, transparency and flexibility are splendid, can flatten fully, the drug contamination of avoiding bottled transfusion air exchange to bring.
3, anti-121 degree high-temperature sterilizations 30 fens no leakages, physical property does not descend, and still can keep good toughness under low temperature environment, has solved the difficult problem that vial can not refrigerate, the multilayer film after high-energy electron irradiation is handled especially, its performance in this regard is good especially.
4, water and OTR oxygen transmission rate are very low, and barrier property is good especially, can make two chamber bags or multi-chamber-bag, and the different soups of can in same bag firmly one are clapped and can be mixed, and reduce time of compounding, make things convenient for hospital to use.
5, drug compatibility widely can not play bad reaction with soup.
6, heat sealing strength height, percolation ratio is low, adapts to various automatic filling machine high-speed and continuous and produces.
7, endurable thorn and impact property are good, anti-2.5 meters drop tests.
8, environment-friendly materials, produce, use and reclaim in do not produce toxin.
Description of drawings
Fig. 1 is the structural representation of embodiment of the invention multi-layer co-extrusion infusion film.
The specific embodiment
Embodiment describes in further detail the present invention below in conjunction with accompanying drawing.
Embodiment
As shown in Figure 1, each layer that has reflected multi-layer co-extrusion infusion film of the present invention situation of arranging.As seen from the figure, it is formed from material and is seen as five-layer structure, and first is followed successively by to each layer of layer 5 and seals internal layer A, adhesive linkage B, core layer C, bonding layer D and weathering layer E.
Selecting melt index for use is that 2.0～15g/10min, density are 0.89～0.9g/cm
3Polypropylene and the hybrid resin formed of SEBS thermoplastic elastomer copolymer, melt index is that 1.5～5g/10min, density are 0.89～0.9g/cm
3Propylene-ethylene copolymers, melt index is that 1～5g/10min, density are 0.89～0.92g/cm
3Propylene-ethylene/a-olefin-copolymerization elastomer, melt index is that 1.5～5g/10min, density are 0.9～0.93g/cm
3The ethylene methacrylate polymer, melt index is that 4～10g/10min, density are 1.1～1.3g/cm
3The elastic resin PETG, as the raw material of making multi-layer co-extrusion infusion film, adopt up-draught cold type coextrusion processing method, preparation multireel multi-layer co-extrusion infusion film, and through 30 minutes high-temperature sterilizations of 121 degree, individual other also adopted high-energy electron irradiation to handle before high-temperature sterilization, and the radiation treatment parameter is: auxilliary is 5,000,000 to draw the spy according to intensity, auxilliary according to the time be 20 minutes.Each is rolled up the concrete performance of multi-layer co-extrusion infusion film and sees Table 1.
Table 1 is respectively rolled up concrete performance
| SEBS content in the ground floor | Ground floor thickness (μ m) | Second layer thickness (μ m) | Threeply degree (μ m) | The 4th layer thickness (μ m) | Layer 5 thickness (μ m) | Whether electron irradiation is handled | |
| Embodiment 1 | ?40wt％ | 30 | ?20 | ?65 | ?20 | ?25 | Not |
| Embodiment 2 | ?50wt％ | 30 | ?20 | ?65 | ?20 | ?25 | Not |
| Embodiment 3 | ?60wt％ | 30 | ?20 | ?65 | ?20 | ?25 | Not |
| Embodiment 4 | ?50wt％ | 30 | ?20 | ?65 | ?20 | ?25 | Be |
| Embodiment 5 | ?50wt％ | 20 | ?15 | ?80 | ?15 | ?36 | Not |
| Embodiment 6 | ?50wt％ | 45 | ?26 | ?50 | ?25 | ?36 | Not |
| Embodiment 7 | ?50wt％ | ?30 | ?26 | ?80 | ?25 | ?18 | Not |
According to the every performance of national each embodiment product of the YBB00342002 of Bureau of Drugs Supervision quality standard test, test result sees Table 2～table 8 respectively.According to " two ones of Chinese pharmacopoeia versions in 2000 are tested multi-layer co-extrusion infusion film and Dextrose and Sodium Chloride Inj. compatibility, the results are shown in Table 9.
By data in the table as seen, the multi-layer co-extrusion infusion film that the present invention obtains has excellent comprehensive performances.Wherein, compare with the multi-layer co-extrusion infusion film of handling without electron irradiation, the multi-layer co-extrusion infusion film of handling through electron irradiation has clear improvement aspect transparent.
Multi-layer co-extrusion infusion film physics, sanitation performance detect data among table 2, the embodiment 1:
| Project | Method of testing | The YBB00342002 standard index | The five-layer co-squeezing film detects data | |
| Hot strength, MPa | Vertically 〉= | ??GB/T13022-91 | ????30 | ????35.5 |
| Laterally 〉= | ??GB/T13022-91 | ????24 | ????30.6 | |
| Tension fracture elongation rate % | Vertically 〉= | ??GB/T13022-91 | ????400 | ????486 |
| Laterally 〉= | ??GB/T13022-91 | ????400 | ????465 | |
| Heat sealing strength | Must not be lower than 20N/15mm | ????34N/15mm | ||
| Light transmittance % | ??GB2410-89 | Must not be lower than 75 | ????76 | |
| Glossiness % | ??GB8807-88 | ????80 | ????81％ | |
| Vapor permeation (g/m 2·24h) | ??GB1037-1988 | Must not surpass 5g | ????3.8g | |
| Oxygen transit dose (m 2·24h·0.1Mpa) | ??GB/T1038-2000 | Must not surpass 1200cm 3 | ????951cm3 | |
| Nitrogen transit dose (m 2·24h·0.1Mpa) | ??GB/T1038-2000 | Must not surpass 600cm 3 | ????517cm3 | |
| Residue on ignition | Must not surpass 0.05% | ????0.04％ | ||
| Particulate matter | Particle diameter 〉=5um 〉=10um 〉=25um | Must not cross 100/ml must not cross 20/ml and must not cross 2/ml | 1/ml of 17/ml of 69/ml | |
| 6 metallic elements | Version pharmacopeia in 2000 | Must not cross 3/1000000ths | Less than 3/1000000ths | |
| Drug release test | Version pharmacopeia in 2000 | 15 test items | All qualified | |
| Bacterial endotoxin | Version pharmacopeia in 2000 | Must not cross 0.25EU/ml | Qualified |
| Cytotoxicity | ??GB/T14233.2-93 | Must not cross 2 grades | Qualified |
| Sensitization test (STT) | ??GB/T14233.2-93 | Do not produce sensitization | Qualified |
| The intracutaneous irritant test | ??GB/T14233.2-93 | Have no stimulation | Qualified |
| Acute general toxicity test | ??GB/T14233.2-93 | No acute toxicity | Qualified |
| Hemolytic test | ??GB/T14233.2-93 | Hemolysis rate must not cross 5% | Qualified |
Multi-layer co-extrusion infusion film physics, sanitation performance detect data among table 3, the embodiment 2:
| Project | Method of testing | The YBB00342002 standard index | The five-layer co-squeezing film detects data | |
| Hot strength, MPa | Vertically 〉= | ??GB/T13022-91 | ????30 | ????36.8 |
| Laterally 〉= | ??GB/T13022-91 | ????24 | ????31.1 | |
| Tension fracture elongation rate % | Vertically 〉= | ??GB/T13022-91 | ????400 | ????499 |
| Laterally 〉= | ??GB/T13022-91 | ????400 | ????471 | |
| Heat sealing strength | Must not be lower than 20N/15mm | ????35N/15mm | ||
| Light transmittance % | ??GB2410-89 | Must not be lower than 75 | ????77 | |
| Glossiness % | ??GB8807-88 | ????80 | ????82％ | |
| Vapor permeation (g/m 2·24h) | ??GB1037-1988 | Must not surpass 5g | ????3.9g | |
| Oxygen transit dose (m 2·24h·0.1Mpa) | ??GB/T1038-2000 | Must not surpass 1200cm 3 | ????891cm3 | |
| Nitrogen transit dose (m 2·24h·0.1Mpa) | ??GB/T1038-2000 | Must not surpass 600cm 3 | ????551cm3 | |
| Residue on ignition | Must not surpass 0.05% | ????0.04％ | ||
| Particulate matter | Particle diameter 〉=5um 〉=10um 〉=25um | Must not cross 100/ml must not cross 20/ml and must not cross 2/ml | 1/ml of 12/ml of 53/ml | |
| 6 metallic elements | Version pharmacopeia in 2000 | Must not cross 3/1000000ths | Less than 3/1000000ths | |
| Drug release test | Version pharmacopeia in 2000 | 15 test items | All qualified | |
| Bacterial endotoxin | Version pharmacopeia in 2000 | Must not cross 0.25EU/ml | Qualified | |
| Cytotoxicity | ??GB/T14233.2-93 | Must not cross 2 grades | Qualified | |
| Sensitization test (STT) | ??GB/T14233.2-93 | Do not produce sensitization | Qualified |
| The intracutaneous irritant test | ??GB/T14233.2-93 | Have no stimulation | Qualified |
| Acute general toxicity test | ??GB/T14233.2-93 | No acute toxicity | Qualified |
| Hemolytic test | ??GB/T14233.2-93 | Hemolysis rate must not cross 5% | Qualified |
Multi-layer co-extrusion infusion film physics, sanitation performance detect data among table 4, the embodiment 3:
| Project | Method of testing | The YBB00342002 standard index | The five-layer co-squeezing film detects data | |
| Hot strength, MPa | Vertically 〉= | ??GB/T13022-91 | ????30 | ????38.7 |
| Laterally 〉= | ??GB/T13022-91 | ????24 | ????31.6 | |
| Tension fracture elongation rate % | Vertically 〉= | ??GB/T13022-91 | ????400 | ????507 |
| Laterally 〉= | ??GB/T13022-91 | ????400 | ????468 | |
| Heat sealing strength | Must not be lower than 20N/15mm | ????37N/15mm | ||
| Light transmittance % | ??GB2410-89 | Must not be lower than 75 | ????85 | |
| Glossiness % | ??GB8807-88 | ????80 | ????81％ | |
| Vapor permeation (g/m 2·24h) | ??GB1037-1988 | Must not surpass 5g | ????3.9g | |
| Oxygen transit dose (m 2·24h·0.1Mpa) | ??GB/T1038-2000 | Must not surpass 1200cm 3 | ????881cm3 | |
| Nitrogen transit dose (m 2·24h·0.1Mpa) | ??GB/T1038-2000 | Must not surpass 600cm 3 | ????492cm3 | |
| Residue on ignition | Must not surpass 0.05% | ????0.04％ | ||
| Particulate matter | Particle diameter 〉=5um 〉=10um 〉=25um | Must not cross 100/ml must not cross 20/ml and must not cross 2/ml | 0/ml of 6/ml of 27/ml | |
| 6 metallic elements | Version pharmacopeia in 2000 | Must not cross 3/1000000ths | Less than 3/1000000ths | |
| Drug release test | Version pharmacopeia in 2000 | 15 test items | All qualified | |
| Bacterial endotoxin | Version pharmacopeia in 2000 | Must not cross 0.25EU/ml | Qualified | |
| Cytotoxicity | ??GB/T14233.2-93 | Must not cross 2 grades | Qualified | |
| Sensitization test (STT) | ??GB/T14233.2-93 | Do not produce sensitization | Qualified | |
| The intracutaneous irritant test | ??GB/T14233.2-93 | Have no stimulation | Qualified | |
| Acute general toxicity test | ??GB/T14233.2-93 | No acute toxicity | Qualified |
| Hemolytic test | ??GB/T14233.2-93 | Hemolysis rate must not cross 5% | Qualified |
Multi-layer co-extrusion infusion film physics, sanitation performance detect data among table 5, the embodiment 4:
| Project | Method of testing | The YBB00342002 standard index | The five-layer co-squeezing film detects data | |
| Hot strength, MPa | Vertically 〉= | ??GB/T13022-91 | ????30 | ????39.1 |
| Laterally 〉= | ??GB/T13022-91 | ????24 | ????32.5 | |
| Tension fracture elongation rate % | Vertically 〉= | ??GB/T13022-91 | ????400 | ????516 |
| Laterally 〉= | ??GB/T13022-91 | ????400 | ????478 | |
| Heat sealing strength | Must not be lower than 20N/15mm | ????38N/15mm | ||
| Light transmittance % | ??GB2410-89 | Must not be lower than 75 | ????89.5 | |
| Glossiness % | ??GB8807-88 | ????80 | ????86％ | |
| Vapor permeation (g/m 2·24h) | ??GB1037-1988 | Must not surpass 5g | ????3.6g | |
| Oxygen transit dose (m 2·24h·0.1Mpa) | ??GB/T1038-2000 | Must not surpass 1200cm 3 | ????758cm3 | |
| Nitrogen transit dose (m 2·24h·0.1Mpa) | ??GB/T1038-2000 | Must not surpass 600cm 3 | ????418cm3 | |
| Residue on ignition | Must not surpass 0.05% | ????0.04％ | ||
| Particulate matter | Particle diameter 〉=5um 〉=10um 〉=25um | Must not cross 100/ml must not cross 20/ml and must not cross 2/ml | 0/ml of 5/ml of 28/ml | |
| 6 metallic elements | Version pharmacopeia in 2000 | Must not cross 3/1000000ths | Less than 3/1000000ths | |
| Drug release test | Version pharmacopeia in 2000 | 15 test items | All qualified | |
| Bacterial endotoxin | Version pharmacopeia in 2000 | Must not cross 0.25EU/ml | Qualified | |
| Cytotoxicity | ??GB/T14233.2-93 | Must not cross 2 grades | Qualified | |
| Sensitization test (STT) | ??GB/T14233.2-93 | Do not produce sensitization | Qualified | |
| The intracutaneous irritant test | ??GB/T14233.2-93 | Have no stimulation | Qualified | |
| Acute general toxicity test | ??GB/T14233.2-93 | No acute toxicity | Qualified | |
| Hemolytic test | ??GB/T14233.2-93 | Hemolysis rate must not cross 5% | Qualified | |
Multi-layer co-extrusion infusion film physics, sanitation performance detect data among table 6, the embodiment 5:
| Project | Method of testing | The YBB00342002 standard index | The five-layer co-squeezing film detects data | |
| Hot strength, MPa | Vertically 〉= | ??GB/T13022-91 | ????30 | ????31.2 |
| Laterally 〉= | ??GB/T13022-91 | ????24 | ????34.2 | |
| Tension fracture elongation rate % | Vertically 〉= | ??GB/T13022-91 | ????400 | ????527 |
| Laterally 〉= | ??GB/T13022-91 | ????400 | ????465 | |
| Heat sealing strength | Must not be lower than 20N/15mm | ????19N/15mm | ||
| Light transmittance % | ??GB2410-89 | Must not be lower than 75 | ????77 | |
| Glossiness % | ??GB8807-88 | ????80 | ????80％ | |
| Vapor permeation (g/m 2·24h) | ??GB1037-1988 | Must not surpass 5g | ????4.7g | |
| Oxygen transit dose (m 2·24h·0.1Mpa) | ??GB/T1038-2000 | Must not surpass 1200cm 3 | ????789cm3 | |
| Nitrogen transit dose (m 2·24h·0.1Mpa) | ??GB/T1038-2000 | Must not surpass 600cm 3 | ????491cm3 | |
| Residue on ignition | Must not surpass 0.05% | ????0.05％ | ||
| Particulate matter | Particle diameter 〉=5um 〉=10um 〉=25um | Must not cross 100/ml must not cross 20/ml and must not cross 2/ml | 2/ml of 23/ml of 96/ml | |
| 6 metallic elements | Version pharmacopeia in 2000 | Must not cross 3/1000000ths | Less than 3/1000000ths | |
| Drug release test | Version pharmacopeia in 2000 | 15 test items | All qualified | |
| Bacterial endotoxin | Version pharmacopeia in 2000 | Must not cross 0.25EU/ml | Qualified | |
| Cytotoxicity | ??GB/T14233.2-93 | Must not cross 2 grades | Qualified | |
| Sensitization test (STT) | ??GB/T14233.2-93 | Do not produce sensitization | Qualified | |
| The intracutaneous irritant test | ??GB/T14233.2-93 | Have no stimulation | Qualified | |
| Acute general toxicity test | ??GB/T14233.2-93 | No acute toxicity | Qualified | |
| Hemolytic test | ??GB/T14233.2-93 | Hemolysis rate must not cross 5% | Qualified | |
Multi-layer co-extrusion infusion film physics, sanitation performance detect data among table 7, the embodiment 6:
| Project | Method of testing | The YBB00342002 standard index | The five-layer co-squeezing film detects data | |
| Hot strength, MPa | Vertically 〉= | ??GB/T13022-91 | ????30 | ????37.7 |
| Laterally 〉= | ??GB/T13022-91 | ????24 | ????31.6 | |
| Tension fracture elongation rate % | Vertically 〉= | ??GB/T13022-91 | ????400 | ????511 |
| Laterally 〉= | ??GB/T13022-91 | ????400 | ????470 | |
| Heat sealing strength | Must not be lower than 20N/15mm | ????39N/15mm | ||
| Light transmittance % | ??GB2410-89 | Must not be lower than 75 | ????81.2 | |
| Glossiness % | ??GB8807-88 | ????80 | ????80.7％ | |
| Vapor permeation (g/m 2·24h) | ??GB1037-1988 | Must not surpass 5g | ????3.5g | |
| Oxygen transit dose (m 2·24h·0.1Mpa) | ??GB/T1038-2000 | Must not surpass 1200cm 3 | ????756cm3 | |
| Nitrogen transit dose (m 2·24h·0.1Mpa) | ??GB/T1038-2000 | Must not surpass 600cm 3 | ????423cm3 | |
| Residue on ignition | Must not surpass 0.05% | ????0.06％ | ||
| Particulate matter | Particle diameter 〉=5um 〉=10um 〉=25um | Must not cross 100/ml must not cross 20/ml and must not cross 2/ml | 0/ml of 4/ml of 27/ml | |
| 6 metallic elements | Version pharmacopeia in 2000 | Must not cross 3/1000000ths | Less than 3/1000000ths | |
| Drug release test | Version pharmacopeia in 2000 | 15 test items | All qualified | |
| Bacterial endotoxin | Version pharmacopeia in 2000 | Must not cross 0.25EU/ml | Qualified | |
| Cytotoxicity | ??GB/T14233.2-93 | Must not cross 2 grades | Qualified | |
| Sensitization test (STT) | ??GB/T14233.2-93 | Do not produce sensitization | Qualified | |
| The intracutaneous irritant test | ??GB/T14233.2-93 | Have no stimulation | Qualified | |
| Acute general toxicity test | ??GB/T14233.2-93 | No acute toxicity | Qualified | |
| Hemolytic test | ??GB/T14233.2-93 | Hemolysis rate must not cross 5% | Qualified | |
Multi-layer co-extrusion infusion film physics, sanitation performance detect data among table 8, the embodiment 7:
| Project | Method of testing | The YBB00342002 standard index | The five-layer co-squeezing film detects data | |
| Hot strength, MPa | Vertically 〉= | ??GB/T13022-91 | ????30 | ????36.2 |
| Laterally 〉= | ??GB/T13022-91 | ????24 | ????30.8 | |
| Tension fracture elongation rate % | Vertically 〉= | ??GB/T13022-91 | ????400 | ????461 |
| Laterally 〉= | ??GB/T13022-91 | ????400 | ????423 | |
| Heat sealing strength | Must not be lower than 20N/15mm | ????36N/15mm | ||
| Light transmittance % | ??GB2410-89 | Must not be lower than 75 | ????79.3 | |
| Glossiness % | ??GB8807-88 | ????80 | ????79％ | |
| Vapor permeation (g/m 2·24h) | ??GB1037-1988 | Must not surpass 5g | ????5.1g | |
| Oxygen transit dose (m 2·24h·0.1Mpa) | ??GB/T1038-2000 | Must not surpass 1200cm 3 | ????1246cm3 | |
| Nitrogen transit dose (m 2·24h·0.1Mpa) | ??GB/T1038-2000 | Must not surpass 600cm 3 | ????631cm3 | |
| Residue on ignition | Must not surpass 0.05% | ????0.04％ | ||
| Particulate matter | Particle diameter 〉=5um 〉=10um 〉=25um | Must not cross 100/ml must not cross 20/ml and must not cross 2/ml | 1/ml of 8/ml of 40/ml | |
| 6 metallic elements | Version pharmacopeia in 2000 | Must not cross 3/1000000ths | Less than 3/1000000ths | |
| Drug release test | Version pharmacopeia in 2000 | 15 test items | All qualified | |
| Bacterial endotoxin | Version pharmacopeia in 2000 | Must not cross 0.25EU/ml | Qualified | |
| Cytotoxicity | ??GB/T14233.2-93 | Must not cross 2 grades | Qualified | |
| Sensitization test (STT) | ??GB/T14233.2-93 | Do not produce sensitization | Qualified | |
| The intracutaneous irritant test | ??GB/T14233.2-93 | Have no stimulation | Qualified | |
| Acute general toxicity test | ??GB/T14233.2-93 | No acute toxicity | Qualified | |
| Hemolytic test | ??GB/T14233.2-93 | Hemolysis rate must not cross 5% | Qualified | |
Table 9. multi-layer co-extrusion infusion film and the report of Dextrose and Sodium Chloride Inj. compatibility test
| Inspection product title | Glucose sugar sodium chloride injection | Experimental condition | 40 ℃ ± 2 ℃ humidity 20% ± 5% of accelerated test temperature |
| Lot number | 040,705 1 | Specification | 250ml: glucose 12.5g and sodium chloride 2.25g |
| Packing | A multi-layer co-extrusion infusion bag film lot number 040604 | The check purpose | Accelerated test 6 months |
| Inspection product quantity | 28 bags | ||
| For sample unit | High-capacity injection G workshop | Receive the inspection date | On July 6th, 2004 |
| Test basis | " two ones of Chinese pharmacopoeia versions in 2000 | Reporting date | On January 13rd, 2005 |
| Interventions Requested standard code assay [proterties] should be colourless colourless clear liquid [inspection] the pH value of clear liquid and should be 3.5～5.5 3.9 5-hydroxymethylfurfurals at the wavelength place of 284nm, and trap must not must not cross 5/1000000ths greater than 0.25 0.06 heavy metal should clarity up to specification (disqualification rate) must not cross less than 5/1000000ths particulate matters that 5% bacterial endotoxin up to specification is should be up to specification aseptic should [assay] up to specification to contain glucose (C6H 12O 6H 2O) should be 95.0% of labelled amount～105.0% 98.0% sodium chloride-containing (NaCl) and should be 95.0% of labelled amount～105.0% 98.3% | |||
| Conclusion: this product is by " two checks of Chinese pharmacopoeia version in 2000, the result is up to specification. | |||
Claims (10)
1, a kind of multi-layer co-extrusion infusion film is seen as five-layer structure from the material composition, it is characterized in that:
Ground floor is heat-sealing internal layer A, and its composition is the hybrid resin that polypropylene and SEBS thermoplastic elastomer copolymer form, and SEBS refers to styrene-ethylene-butene rubber-styrene block copolymer;
The second layer is adhesive linkage B, and its composition is a propylene-ethylene copolymers;
The 3rd layer is core layer C, and its composition is propylene-ethylene/a-olefin-copolymerization elastomer;
The 4th layer is bonding layer D, and its composition is the ethylene methacrylate polymer;
Layer 5 is weathering layer E, and its composition is the elastic resin PETG.
2, multi-layer co-extrusion infusion film according to claim 1 is characterized in that the addition of SEBS thermoplastic elastomer copolymer in described hybrid resin is 40-60wt% described in the described heat-sealing internal layer A.
3, multi-layer co-extrusion infusion film according to claim 1 and 2 is characterized in that the melt index of the hybrid resin that used polypropylene and SEBS thermoplastic elastomer copolymer are formed among the described heat-sealing internal layer A is 2.0～15g/10min, and density is 0.89～0.9g/cm
3
4, multi-layer co-extrusion infusion film according to claim 1 and 2, the melt index that it is characterized in that used propylene-ethylene copolymers among the described adhesive linkage B is 1.5～5g/10min, density is 0.89～0.9g/cm
3
5, multi-layer co-extrusion infusion film according to claim 1 and 2 is characterized in that used propylene-ethylene among the described core layer C/elastomeric melt index of a-olefin-copolymerization is 1～5g/10min, and density is 0.89～0.92g/cm
3
6, multi-layer co-extrusion infusion film according to claim 1 and 2, the melt index that it is characterized in that used ethylene methacrylate polymer in the described bonding layer D is 1.5～5g/10min, density is 0.9～0.93g/cm
3
7, multi-layer co-extrusion infusion film according to claim 1 and 2, the melt index that it is characterized in that used elastic resin PETG among the described weathering layer E is 4～10g/10min, density is 1.1～1.3g/cm
3
8, multi-layer co-extrusion infusion film according to claim 1 and 2, the thickness that it is characterized in that described heat-sealing internal layer A is 20～45 μ m, accounts for 15～25% of multi-layer co-extrusion infusion film gross thickness; The thickness of described adhesive linkage B is 15～26 μ m, accounts for 8～15% of multi-layer co-extrusion infusion film gross thickness; The thickness of described core layer C is 50～80 μ m, accounts for 30～45% of multi-layer co-extrusion infusion film gross thickness; The thickness of described bonding layer D is 15～25 μ m, accounts for 8～14% of multi-layer co-extrusion infusion film gross thickness; The thickness of described weathering layer E is 18～36 μ m, accounts for 10～20% of multi-layer co-extrusion infusion film gross thickness.
9, multi-layer co-extrusion infusion film according to claim 8, the gross thickness that it is characterized in that described multi-layer co-extrusion infusion film are 150～190 μ m.
10, a kind of method of making multi-layer co-extrusion infusion film as claimed in claim 1, it adopts up-draught cold type coextrusion process, it is characterized in that in the co-extrusion traction, adopt high-energy electron irradiation or X ray to carry out radiation to co-extrusion gained multilayer film, auxilliary is that 2-8 million draws the spy according to intensity, and assisting the time of photograph is 10～40 minutes.
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| US20020142115A1 (en) * | 2000-11-01 | 2002-10-03 | Mitsubishi Engineering-Plastics Corp. | Multi-layer film bag for packaging medical liquid |
| DE60231964D1 (en) * | 2001-01-15 | 2009-05-28 | Hosokawa Yoko Kk | LAMINATE AND TANK |
| JP4321042B2 (en) * | 2002-10-30 | 2009-08-26 | 凸版印刷株式会社 | Packaging material with pinhole resistance |
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2005
- 2005-02-01 CN CNB200510049011XA patent/CN100389948C/en not_active Expired - Fee Related
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