JP6746984B2 - Bag for fresh frozen plasma products - Google Patents

Description

The present invention relates to a blood bag for a fresh frozen plasma preparation having an inner layer having heat-sealing properties, low temperature impact resistance, blocking resistance when sterilized at high temperature without containing contents, hygiene, heat resistance and the like. ..

Blood used for blood transfusion in the medical field is usually used for blood transfusion after the blood obtained by a donor's blood donation is separated into individual components and stored. For example, whole blood is placed in a sampling bag and centrifuged to separate it into a low density (low specific gravity) component and a high density (high specific gravity) red blood cell component, and the blood sampling bag is pressurized to give plasma as a supernatant component. Is transferred to the blood bag for plasma preparation through the tube, and the tube is sealed and cut. As a result, whole blood is fractionated into a plasma component and a red blood cell component, and the fractionated components are used as a plasma preparation and a red blood cell preparation. Here, the blood bag for plasma preparation used for collecting plasma has been subjected to high temperature sterilization treatment in advance.
The plasma preparation fractionated in the blood bag for plasma preparation is frozen and stored as a fresh frozen plasma preparation (FFP). When using the fresh frozen plasma preparation, the fresh frozen plasma preparation together with the blood bag is thawed in hot water of about 30 to 37° C. using a thermostat or FFP melting device, and then used for blood transfusion.

For these reasons, blood bags for fresh frozen plasma preparations are required to have low-temperature impact resistance that withstands freezing processing temperatures, and blocking resistance, heat resistance, and hygiene when subjected to high temperature sterilization without the contents. It In addition, the blood bag for a plasma preparation is usually packaged by heat-sealing the peripheral portions of the single-wafer-shaped films cut into a predetermined shape to form a bag-like shape, and therefore, is The layer to be formed also needs a heat-sealing property for packaging.

Conventionally, a soft vinyl chloride resin composition has been generally used as a material forming a blood bag because of its excellent flexibility, blood preservability, and the like (Non-Patent Document 1). On the other hand, a material using a polyolefin-based resin composition is also disclosed as a material for forming a blood bag. For example, polyethylene or ethylene.α polymerized by a metallocene catalyst having a density of 0.860 to 0.930 g/cm ³ is disclosed. -A olefin copolymer containing a specific amount is disclosed (Patent Document 1).

Liquid storage bags used in the medical field include blood bags and so-called infusion bags. The infusion bag contains liquid pharmaceuticals such as amino acid infusions, electrolyte infusions, sugar infusions, fat emulsions for infusions, etc. To be distinguished.

JP-A-2002-136572

Journal of the Japan Society of Blood Transformation 26(5): 301-360, 1980.

In the case of a blood bag using the soft vinyl chloride resin composition as described in Non-Patent Document 1, since the low temperature impact resistance is poor, the bag filled with blood is transported and stored in a frozen state. May be damaged.

By the way, the blood bag is sterilized at a high temperature without putting the contents in advance. The present inventor has found that, when the inner layer material as described in Patent Document 1 is used, the inner layer surfaces are blocked when the blood bag is sterilized at high temperature without containing the contents. ..

An object of the present invention is to provide a blood for a fresh frozen plasma preparation, the inner layer of which has heat sealability, low temperature impact resistance, blocking resistance when sterilized at high temperature without putting contents, hygiene, heat resistance and the like. To provide a bag.

As a result of extensive studies to solve the above problems, the present inventor has determined that a predetermined elution characteristic at a predetermined temperature can be obtained as a constituent material of a seal layer that constitutes an inner wall layer in a measurement by a temperature rising elution fractionation method (TREF method). It was found that the above problems can be solved by using the polypropylene resin composition shown. The present invention has been accomplished based on these findings.

That is, the gist of the present invention is as follows [1] to [6].

[1] A multilayer film having at least two layers having a seal layer, the seal layer constituting an inner wall surface, the seal layer being made of a polypropylene resin composition, and the polypropylene resin composition A blood bag for a fresh frozen plasma preparation, which has an integrated elution amount of 10 to 30% by weight up to 80° C. in the temperature rising elution fractionation method (TREF method).

[2] The fresh frozen plasma preparation according to [1], wherein the polypropylene resin composition for the seal layer has an integrated elution amount up to 40° C. in the temperature rising elution fractionation method (TREF method) of 5 to 20% by weight. Blood bag.

[3] The blood for fresh frozen plasma preparation according to [1] or [2], wherein the polypropylene resin composition of the seal layer has a maximum elution temperature of 90° C. or higher in a temperature rising elution fractionation method (TREF method). bag.

[4] In any one of [1] to [3], in the polypropylene resin composition of the seal layer, the cumulative elution amount up to 100° C. in the temperature rising elution fractionation method (TREF method) is 40% by weight or more. A blood bag for the fresh frozen plasma preparation described.

[5] The blood bag for fresh frozen plasma preparation according to any one of [1] to [4], wherein the seal layer has a thickness of 10 to 50 μm.

[6] The multilayer film has a three-layer structure in which the seal layer and the outer layer are laminated via an intermediate layer, the thickness of the seal layer is 10 to 50 μm, and the thickness of the intermediate layer is 100 to 300 μm. The blood bag for fresh frozen plasma preparation according to any one of [1] to [4], wherein the outer layer has a thickness of 10 to 50 μm.

According to the present invention, the inner layer has heat-sealing properties, low-temperature impact resistance, blocking resistance when sterilized at high temperature without putting contents, hygiene, heat resistance, etc. Bags are provided.

BEST MODE FOR CARRYING OUT THE INVENTION Hereinafter, embodiments of the present invention will be described in detail, but the following description is an example of the embodiments of the present invention, and the present invention is limited to the following description unless it exceeds the gist thereof. is not. In addition, when the expression "..." is used in this specification, it is used as an expression including numerical values or physical property values before and after the expression.

The blood bag for fresh frozen plasma preparation of the present invention (hereinafter, may be referred to as “the blood bag of the present invention”) is formed of at least two or more multi-layer films having a sealing layer, and the sealing layer is The seal layer is made of a polypropylene resin composition and constitutes a wall surface, and the polypropylene resin composition has a cumulative elution amount of 10 to 30 weight up to 80° C. in a temperature rising elution fractionation method (TREF method). It is characterized by being %. Hereinafter, the polypropylene-based resin composition forming the seal layer of the blood bag of the present invention may be referred to as the “polypropylene-based resin composition of the present invention”. The polypropylene resin composition of the present invention has an accumulated elution amount up to 40°C of 5 to 20% by weight, an accumulated elution amount up to 100°C of 40% by weight or more, and a maximum elution temperature in the temperature rising elution fractionation method (TREF method). Is preferably 90° C. or higher.
In addition, the multilayer film constituting the blood bag of the present invention may have a three-layer structure in which the seal layer and the outer layer are laminated via an intermediate layer (hereinafter, may be referred to as “multilayer film of the present invention”). .) is preferable.

[Raised temperature elution fractionation method (TREF method)]
The temperature rising elution fractionation method (TREF method) is a method of gradually elevating the temperature of a sample (polypropylene resin composition) from a low temperature region to a high temperature region and separating eluent components at each temperature. It is well known as a measuring method used for evaluating the crystallinity of a composition. For example, detailed measuring methods are shown in the following Documents 1) to 3) and are well known to those skilled in the art.
1) G. Glockner, J.; Appl. Polym. Sci. : Appl. Polym. Symp. 45.1-24 (1990)
2) L. Wild. Adv. Polym. Sci. 98.1-47 (1990)
3) J. B. P. Soares, A.; E. Hamielec. Polymer; 36, 8, 1639-1654 (1995).

The elution amount of the polypropylene resin composition according to the present invention is specifically measured by the following method.

<Measurement of elution amount by temperature rising elution fractionation method (TREF method)>
In the measurement of the elution amount by the temperature rising elution fractionation method (TREF method) in the present invention, 50 mg of the sample was dissolved by heating in 20 mL of orthodichlorobenzene (ODCB) to which 0.1 g/L dibutylhydroxytoluene (BHT) was added. The elution amount is measured under the following conditions by a cross fractionation chromatography (CFC) measurement.
Device: PolymerChAR CFC-2
Detector: IR detector (built-in)
Mobile phase: Reagent grade ODCB
Flow rate: 1.0 mL/min Injection: 2.5 mg/mL x 400 μL
Column: TSKgel GMH6-HT
(7.5 mm ID×30 cmL×4)
Column bath temperature: 135℃
Dissolution conditions: 60 minutes/135°C
Cooling condition: 135 minutes/135℃→0℃
TREF column: Stainless steel bead elution category: 36 category calibration sample: Monodisperse polystyrene calibration method: Polypropylene conversion (general-purpose calibration curve method)
Calibration curve formula: cubic formula

[Polypropylene resin composition]
The polypropylene resin composition of the present invention has a cumulative elution amount up to 80°C of 10 to 30% by weight in the temperature rising elution fractionation method (TREF method).
A cumulative elution amount of up to 80° C. of 10% by weight or more means that the polypropylene resin composition elutes up to this temperature, whereby heat sealing properties can be imparted to the seal layer. On the other hand, the fact that the cumulative elution amount up to 80° C. is 30% by weight or less means that the elution amount of the polypropylene resin composition up to this temperature is small to some extent, and the sealing layer of the seal layer during sterilization at high temperature is small. Blocking resistance can be obtained. In order to obtain the above effects more reliably, the polypropylene resin composition of the present invention preferably has an integrated elution amount up to 80°C of 12 to 28% by weight in the temperature rising elution fractionation method (TREF method). ..

In addition, the polypropylene resin composition of the present invention preferably has an integrated elution amount up to 40°C of 5 to 20% by weight in the temperature rising elution fractionation method (TREF method). The fact that the cumulative elution amount up to 40° C. is 5% by weight or more means that the polypropylene-based resin composition elutes at this temperature, which can improve the heat-sealing property of the seal layer. On the other hand, the fact that the cumulative elution amount up to 40° C. is 20% by weight or less means that the elution amount of the polypropylene resin composition is somewhat small up to this temperature, and the elution amount of the sealing layer during sterilization at high temperature is small. Blocking resistance can be improved. In order to obtain the above effects more reliably, the polypropylene resin composition of the present invention preferably has an integrated elution amount up to 40°C of 7 to 18% by weight in the temperature rising elution fractionation method (TREF method). ..

Further, the polypropylene resin composition of the present invention preferably has a maximum elution temperature of 90° C. or higher in the temperature rising elution fractionation method (TREF method).
When the maximum elution temperature is 90°C or higher, the blocking resistance of the seal layer at the time of sterilization at high temperature is improved. From the viewpoint of blocking resistance, the higher the maximum elution temperature is, the more preferable, and the more preferable temperature is 100° C. or higher. Although the upper limit of the maximum elution temperature is not limited, the maximum elution temperature of the polypropylene resin composition is usually 120°C or lower.

Further, the polypropylene resin composition of the present invention preferably has an integrated elution amount up to 100° C. in the temperature rising elution fractionation method (TREF method) of 40% by weight or more.
The cumulative elution amount up to 100° C. being 40% by weight or more means that the polypropylene resin composition elutes to some extent up to this temperature, which can improve the heat-sealing property of the seal layer. .. From the viewpoint of heat sealability, the larger the integrated elution amount up to 100° C., the more preferable, and it is preferably 42% by weight or more. On the other hand, from the viewpoint of heat resistance, the upper limit of the elution amount at 100° C. is preferably 70% by weight or less, more preferably 68% by weight or less.

Further, as the elution characteristics of the polypropylene resin composition of the present invention in the temperature rising elution fractionation method (TREF method), the integrated elution amount up to 20° C. is preferably 10% by weight or less, particularly 3 to 8% by weight, The cumulative elution amount up to 60°C is preferably 10 to 20% by weight, and the cumulative elution amount up to 80°C is preferably 18 to 28% by weight.

There is no particular limitation on the method for producing a polypropylene-based resin composition in which the integrated elution amount in the temperature rising elution fractionation method (TREF method) satisfies the above-mentioned suitable integrated elution amount, and any method may be used as long as it satisfies the above-mentioned integrated elution amount. For example, the polypropylene resin composition of the present invention may be produced by any method, for example, it is prepared by melt-kneading a propylene homopolymer and a propylene/α-olefin copolymer. be able to.

The propylene/α-olefin copolymer melt-kneaded with the propylene homopolymer is particularly preferably a propylene/α-olefin random copolymer, and the α-olefin has 2 or 4 to 20 carbon atoms. Are preferred, for example, ethylene, 1-butene, 1-pentene, 1-hexene, 3-methyl-1-butene, α-olefins other than propylene such as 4-methyl1-pentene, styrene, vinylcyclopentene, vinylcyclohexane, One or more vinyl compounds such as vinyl norbornane may be used. Of these, ethylene and/or 1-butene are preferable, and ethylene is particularly preferable.

The α-olefin content of the propylene/α-olefin copolymer is not particularly limited, but in general, the higher the α-olefin content in the propylene/α-olefin random copolymer, the higher temperature elution fractionation method (TREF method). ), the integrated elution amount increases and tends to decrease as the α-olefin content decreases. When a polypropylene-based resin composition is produced by melt-kneading a propylene homopolymer and a propylene/α-olefin copolymer, the temperature rising elution fractionation method (TREF) is used as the amount of the propylene/α-olefin copolymer used increases. Method), the integrated elution amount tends to increase, and the smaller it tends to decrease.
Therefore, by appropriately adjusting the α-olefin content of the propylene/α-olefin copolymer used and the mixing ratio of the propylene homopolymer and the propylene/α-olefin copolymer, the above-mentioned elution characteristics are satisfied. The polypropylene resin composition of the present invention can be manufactured.

That is, for example, when the polypropylene resin composition obtained by melt-kneading a propylene homopolymer and a propylene/α-olefin copolymer has a cumulative elution amount up to 80°C of more than 30% by weight, propylene/ It suffices to reduce the proportion of the α-olefin copolymer. On the contrary, when the amount is less than 10% by weight, the proportion of the propylene/α-olefin copolymer may be increased.

The cumulative elution amount up to 40°C can be adjusted by increasing or decreasing the ratio of the propylene/α-olefin copolymer. Further, the cumulative elution amount up to 100° C. can be adjusted by increasing or decreasing the ratio of the propylene/α-olefin copolymer. Further, the maximum elution temperature can be adjusted by increasing or decreasing the ratio of the propylene/α-olefin copolymer.

As described above, the polypropylene resin composition of the present invention comprises a propylene homopolymer and a propylene/α-olefin copolymer, an α-olefin content of the propylene/α-olefin copolymer and a ratio of use thereof. Can be manufactured by appropriately adjusting and melt-kneading.

In order to satisfy the cumulative elution amount detailed above, the propylene homopolymer and the propylene/α-olefin copolymer should contain 1 to 120% by weight of the propylene homopolymer with respect to the total amount thereof. Is more preferable, 3 to 15% by weight is more preferable, and 5 to 10% by weight is further preferable.

[Outer layer]
The outer layer of the multilayer film of the present invention is usually composed of a thermoplastic resin, and the kind thereof is not particularly limited, but it is preferably composed of a resin composition containing a propylene polymer as a main component. Here, "to be a main component" means to occupy more than 50% by weight in the resin composition, and it is particularly preferable that the propylene-based polymer is contained in an amount of 60% by weight or more. The upper limit of the amount is 100% by weight. When the content of the propylene-based polymer is at least the above lower limit, the handleability of the film during heat sealing tends to be good. The "propylene-based polymer" referred to herein means a polymer containing propylene in an amount of more than 50 mol% with respect to the entire raw material monomer components.

Further, the resin composition forming the outer layer may contain components other than the propylene polymer, and may contain, for example, a styrene elastomer and/or a hydrogenated product thereof. The styrene elastomer has a styrene polymer block and a conjugated gen polymer block, and examples of the conjugated diene polymer block include those derived from butadiene and isoprene. When using a styrene-based elastomer and/or its hydrogenated product, its content is preferably 10 to 40% by weight based on the total of the propylene-based polymer and the styrene-based elastomer and/or its hydrogenated product. It is more preferably 15 to 30% by weight.

Here, the resin composition forming the outer layer preferably has the following physical properties.
Density: 0.88-0.91 g/cm ³
MFR: 1.0 to 10 g/10 minutes Bending elastic modulus: 300 to 1500 MPa

When the density (ISO 1183) of the resin composition constituting the outer layer is at least the above lower limit value, the heat sealability tends to be good, and when it is at most the above upper limit value, the transparency tends to be good. Further, when the MFR (ISO 1133 (measurement temperature 230°C, load 21.2N)) is in the above range, it is preferable from the viewpoint of moldability. Further, when the flexural modulus (ISO 178) is not less than the lower limit value, the heat sealability tends to be good, and when it is not more than the upper limit value, impact resistance and flexibility tend to be good.

[Middle layer]
The intermediate layer is usually composed of a thermoplastic resin, and the kind thereof is not particularly limited, but it is preferably made of a propylene polymer having the following physical properties.
MFR: 1.0 to 7.0 g/10 minutes Flexural modulus: 10 to 300 MPa and/or Duro hardness A: 70 to 95

The MFR (ISO 1133 (measurement temperature 230° C., load 21.2 N)) of the propylene-based polymer forming the intermediate layer is preferably within the above range from the viewpoint of moldability. Particularly, when it is at least the above lower limit value, it is preferable in T-die molding, and when it is at most the above upper limit value, it is preferable in water cooling inflation molding. Further, when the flexural modulus (ISO 178) and/or the Duro hardness A (ISO 7619) is at least the above lower limit, the heat-sealing property tends to be good, and when it is at most the above upper limit, the flexibility of the entire multilayer film is reduced. The tendency tends to be good.

[Other layers]
The multilayer film of the present invention may further have a seal layer, an intermediate layer, an outer layer and, if necessary, further any layer.
That is, the sealing layer, the intermediate layer and the outer layer may be in direct contact with each other, or an adhesive layer may be present between these layers. Further, on the outer layer (the part which becomes the outer wall side when used as a blood bag), the outermost layer further comprises a polyester layer for improving heat sealability, appearance, glossiness, film toughness, etc., especially an alicyclic type. It may have other layers such as a layer made of polyester or a layer made of polyester vapor-deposited with silica and/or alumina for improving gas barrier properties.

The adhesive layer is a layer of an adhesive or an adhesive resin that is located between the seal layer and the intermediate layer, or between the intermediate layer and the outer layer, and bonds them together. Examples of the adhesive include a polyurethane-based adhesive, and the adhesive resin includes polyolefin, an acid-modified polyolefin obtained by modifying it with an acid such as maleic anhydride, and a copolymer of ethylene and a monomer having a carboxyl group. Can be mentioned.

[Method for producing multilayer film]
The method for producing the multilayer film of the present invention may be any method as long as the above layers can be laminated and integrated, and examples thereof include dry lamination, extrusion lamination, and coextrusion lamination (T die method, water cooling). Examples include an inflation method, an air-cooled inflation method), heat lamination, or a lamination method combining these methods. Among these, the water cooling inflation method is particularly preferable from the viewpoint of obtaining transparency of the entire multilayer film and the sealing property of the seal layer, and the molding temperature thereof is usually about 200 to 230°C.

[Thickness of each layer and multilayer film]
The thickness of the seal layer of the multilayer film of the present invention is preferably 10 to 50 μm, and particularly preferably 15 to 35 μm. When the thickness of the seal layer is at least the above lower limit, it is preferable from the viewpoint of stability of seal strength, and when it is at most the above upper limit, it is preferable in terms of flexibility of the entire multilayer film.

The thickness of the outer layer of the multilayer film of the present invention is preferably 10 to 50 μm, and particularly preferably 5 to 40 μm. The outer layer is mainly responsible for mechanical strength of the multilayer film, improvement of heat sealability, etc., but when the thickness of the outer layer is the above lower limit or more, it is preferable because the film forming property is stable, and the above upper limit. The following is preferable in terms of flexibility of the whole multilayer film.

The thickness of the intermediate layer of the multilayer film of the present invention is preferably 100 to 300 μm, and particularly preferably 200 to 250 μm. The intermediate layer is usually provided to secure the strength of the entire film, and is preferably at least the above lower limit to achieve this object, and is also preferable in terms of flexibility of the entire film. When it is at most the above upper limit, the film has a proper elasticity and the handling property (handling property) as a bag becomes good, which is preferable.

In particular, the multilayer film of the present invention preferably has a thickness ratio of (seal layer):(outer layer)=1:0.1 to 1:10.

When the above-mentioned adhesive layer is further provided, the thickness thereof is appropriately determined according to the overall specifications of the multilayer film, the type of adhesive used, the adhesiveness required for the adhesive layer, and the like.

The thickness of the other layers provided as necessary in the multilayer film of the present invention is also appropriately determined according to the purpose of formation thereof, but the thickness of the multilayer film of the present invention (the total thickness of each layer constituting the multilayer film Is preferably 200 to 400 μm, more preferably 250 to 300 μm. It is preferable that the thickness of the multilayer film is equal to or more than the above lower limit, because the thickness of a necessary layer such as a seal layer can be sufficiently secured, and it is preferable from the viewpoint of sealing property, mechanical strength and other required characteristics. When the thickness of the multilayer film is less than or equal to the above upper limit, it is preferable from the viewpoints of thinness and weight reduction, and it is also advantageous from the viewpoints of cost, handleability, and processability.

[Method of manufacturing blood bag]
As a method for producing the blood bag of the present invention using the multilayer film of the present invention, a sheet forming method (thermoforming method) such as vacuum forming or pressure forming, a blow forming method such as multilayer coextrusion blow forming, or a predetermined method is used. Any method may be used, such as a method of producing a bag-like product by heat-sealing (strong welding) or adhering the peripheral portions of the single-wafer-shaped multilayer films cut into the shape of 1 to each other with an adhesive.

The heat-sealing temperature in the case of forming a bag shape by heat-sealing the peripheral portions of the sheet-shaped multilayer films cut into a predetermined shape is the component composition of the seal layer-forming composition, the seal layer and the multilayer film. The temperature is usually about 40 to 180° C., though it varies depending on the total thickness.

Hereinafter, the content of the present invention will be described more specifically with reference to Examples, but the present invention is not limited to the following Examples unless it exceeds the gist. The values of various production conditions and evaluation results in the following examples have meanings as preferable values of the upper limit or the lower limit in the embodiments of the present invention, and the preferable range is the above-mentioned upper limit value or the lower limit value, It may be a range defined by a value of the embodiment or a combination of the values of the embodiments.

〔material〕
(Outer layer)
-Polypropylene resin (1): (Mitsubishi Chemical Corporation Zelas (registered trademark) 7025 (flexural modulus: 600 MPa, density: 0.89 g/cm ³ , MFR (230°C, 21.2 N): 1.8 g/10) Minutes))
(Middle layer)
-Polypropylene resin (2): (Mitsubishi Chemical Corporation Zelas (registered trademark) MC717R4 (Duro hardness A: 88, MFR (230°C, 21.2N): 2.5 g/10 minutes))
(Inner layer (seal layer))
X-1 (for examples): polypropylene resin composition of 94% by weight of propylene/ethylene random copolymer and 6% by weight of propylene homopolymer (cylinder temperature 200° C., screw rotation speed 250 rpm by a twin-screw extruder, Obtained by melt-kneading at a discharge rate of 10 kg/h)
X-1 (for comparative example): polypropylene resin composition of 90% by weight of propylene/ethylene/butylene copolymer, 6% by weight of propylene/ethylene copolymer and 4% by weight of propylene homopolymer (biaxial extruder) Obtained by melt-kneading at a cylinder temperature of 200° C., a screw rotation speed of 250 rpm, and a discharge rate of 10 kg/h.

[Measurement of elution amount by temperature rising elution fractionation method (TREF method)]
50 mg of each of the polypropylene-based resin compositions X-1 and x-1 was used and dissolved by heating with 20 mL of ortho-dichlorobenzene (ODCB) to which 0.1 g/L dibutylhydroxytoluene (BHT) was added and cross-fractionation chromatography (Cross). It was subjected to Fractionation Chromatograph (CFC) measurement. The CFC measurement conditions are as follows.
Device: PolymerChAR CFC-2
Detector: IR detector (built-in)
Mobile phase: Reagent grade ODCB
Flow rate: 1.0 mL/min Injection: 2.5 mg/mL x 400 μL
Column: TSKgel GMH6-HT
(7.5 mm ID×30 cmL×4)
Column bath temperature: 135℃
Dissolution conditions: 60 minutes/135°C
Cooling condition: 135 minutes/135℃→0℃
TREF column: Stainless steel bead elution category: 36 category calibration sample: Monodisperse polystyrene calibration method: Polypropylene conversion (general-purpose calibration curve method)
Calibration curve formula: cubic formula

The results are shown in Table 1.

[Example 1]
[Film forming]
A polypropylene resin (1) is used as a material for the outer layer, a polypropylene resin (2) is used as a material for the intermediate layer, and X-1 is used as a material for the seal layer. A multilayer film ([outer layer thickness]/[intermediate layer thickness]/[seal layer thickness]=40/230/30) having a thickness of 300 μm was prepared under the condition of 220° C.

[Film bag making]
The seal layers of the produced film were put together and heat-sealed on four sides at 180° C. to produce a bag having an inner size of 15 cm×20 cm.

[Evaluation]
The following evaluation was performed using the obtained multilayer film or bag.

<Low temperature impact resistance (brittleness test)>
The obtained multilayer film was cut into a strip having a width of 15 mm, and the embrittlement temperature was measured according to ASTM-D1790. It shows that the lower the brittle temperature is, the more excellent the low temperature impact resistance is. The obtained results are shown in Table-2.

<Blocking resistance>
Using the produced bag, after sterilizing treatment at 121° C. for 30 minutes using Nippon Biocon Model 40-II, the blocking state between the inner surfaces of the bag was examined and evaluated according to the following criteria. The obtained results are shown in Table-2.
◯: No blocking.
Δ: No blocking is observed, but a light adhesion that is easily peeled off is observed.
X: The inner surfaces are strongly adhered to each other due to blocking, and whitening marks remain when peeled off.

<Hygiene>
Using the produced bag, a residue test, an eluate test, a transparency test, a water vapor permeation test, and a cytotoxicity test were performed according to the Japanese Pharmacopoeia plastic container test (16th revision). Table 2 shows the obtained judgment results. The test results are shown in Table-3.

[Comparative Example 1]
A multilayer film and a bag were produced in the same manner as in Example 1 except that the material used for the seal layer was changed to x-1, and the blocking resistance and hygiene were evaluated in the same manner. The obtained results are shown in Table-2 and Table-3.

[Comparative Example 2]
Using a commercially available soft polyvinyl chloride resin film having a thickness of 300 μm, a bag was prepared in the same manner as in Example 1, and the low temperature impact resistance of this bag was evaluated in the same manner. The results are shown in Table-2.

From the above results, the blood bag of the present invention using the specific polypropylene resin composition for the seal layer is excellent in heat sealability, low temperature impact resistance, blocking resistance, hygiene, and a blood bag for fresh frozen plasma preparation. It can be seen that the above-mentioned required characteristics are sufficiently satisfied.

Claims (6)

It is formed of at least two or more multi-layer films having a sealing layer, the sealing layer constitutes an inner wall surface, the sealing layer is made of a polypropylene resin composition, and the polypropylene resin composition is heated. elution fractionation method in the (TREF) method, Ri cumulative amount of elution up to 80 ° C. 10 to 30 wt% der,
The polypropylene resin composition contains a propylene homopolymer and a propylene/ethylene copolymer and/or a propylene/1-butene copolymer,
The multilayer film includes three layers of the sealing layer, an intermediate layer and an outer layer,
The thickness of the intermediate layer Ru 200~300μm der fresh frozen plasma product for server Tsu grayed. In the polypropylene resin composition of the sealing layer, the integrated amount of elution up to 40 ° C. during the Atsushi Nobori elution fractionation method (TREF) method is 5 to 20% by weight, Ba for fresh frozen plasma formulation according to claim 1 Tsu Gu. In the polypropylene resin composition of the sealing layer, the maximum elution temperature of 90 ° C. or higher in the temperature rising elution fractionation method (TREF) method, fresh frozen plasma product for server Tsu grayed according to claim 1 or 2. 4. The fresh resin composition according to claim 1, wherein the polypropylene resin composition for the seal layer has an integrated elution amount up to 100° C. in the temperature rising elution fractionation method (TREF method) of 40% by weight or more. Bas Tsu grayed for frozen plasma preparations. The bag for fresh plasma preparation according to any one of claims 1 to 4, wherein the multilayer film has a three-layer structure in which the seal layer and the outer layer are laminated via the intermediate layer. The thickness of the sealing layer becomes 10 to 50 [mu] m, or One thickness of the outer layer is 10 to 50 [mu] m, fresh frozen plasma manufactured agent bag according to any one of claims 1 to 5.