JP3315846B2 - Blood component storage container and connected container - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a blood component storage container suitable for storing blood or blood components, in particular, a liquid containing red blood cells, and a container assembly.

[0002]

2. Description of the Related Art In recent years, as a container for collecting, separating, and storing blood, a blood component storage container formed by laminating sheets made of a thermoplastic resin and fusing the peripheral portions thereof to form a bag is often used. Used.

[0003] The characteristics required of the blood component storage container (blood bag) include transparency for visually confirming the state of blood or blood components as contents liquid, and easy operations such as blood collection, blood transfusion, and blood component separation. Flexibility, flexibility, strength to withstand these operations, hygiene, safety, and the like.

[0004] Since soft polyvinyl chloride almost satisfies the above required performance, it is currently the mainstream of blood bag materials.

In the field of preserving red blood cell components,
The development of a dedicated preservation solution has also been progressing,
A preservation solution (MAP solution, etc.) that can be effectively stored for two days has been developed and put into practical use.

[0006] However, while such a preservation solution has made it possible to preserve erythrocyte components for a long period of time, a huge aggregate (hereinafter, referred to as MA) called a macroaggregate newly occurs after erythrocyte preservation. The problem of doing so is emerging. At present, no method for preventing the occurrence of MA has been developed.

[0007] In preserving red blood cells, it is also important to prevent the hemolysis (destruction of blood cells). That is, if the hemolysis level of the red blood cells increases, the quality of the red blood cell preparation is impaired.

Various methods for preventing this hemolysis have been conventionally proposed, but all methods are methods for suppressing hemolysis only, and methods for simultaneously suppressing hemolysis and the occurrence of MA. Has not been developed yet.

[0009]

SUMMARY OF THE INVENTION An object of the present invention is to suppress the hemolysis of blood cell components when they are stored,
An object of the present invention is to provide a blood component storage container which can suppress the generation of macro aggregates (MA) and has excellent blood component storage properties, and a container connected body including the same.

[0010]

This and other objects are achieved by the present invention which is defined below as (1) to (12).

(1) A blood component storage container which is formed of a soft polyvinyl chloride sheet containing a first plasticizer and a second plasticizer and stores a liquid containing at least a blood cell component. When the plasticizer is blended alone in a polyvinyl chloride sheet at 32% by weight, a predetermined amount of blood component is stored at 4 ° C. for 35 days in a blood component storage container made of the polyvinyl chloride sheet. The plasticizer is soluble in blood components having an elution level of 15 ppm or more in blood components, and the second plasticizer is used alone in a polyvinyl chloride sheet at 32 wt%. When done
The sheet made of polyvinyl chloride has an oxygen gas permeability of 4.0.
A blood component storage container characterized by being at least L / m ² · mm · day · atm (30 ° C).

(2) When the second plasticizer is independently blended in a polyvinyl chloride sheet at 32% by weight, a predetermined amount of a blood component is placed in a blood component storage container made of the polyvinyl chloride sheet. The blood component according to the above (1), wherein the level of dissolution of the plasticizer into the blood component exceeds 35 ppm when stored at 35 ° C. for 35 days, and is lower than the level of dissolution of the first plasticizer. Storage container.

(3) The second plasticizer is an aliphatic or aromatic ester having at least two ester bonds including an aliphatic hydrocarbon group having at least four carbon atoms in each hydrocarbon chain. The blood component storage container according to (1) or (2).

(4) The second plasticizer is a phthalic acid diester, a dialkyl phthalate, an adipic acid ester or a dialkyl adipate, each having two or more aliphatic hydrocarbon groups having 4 to 12 carbon atoms. The blood component storage container according to (3).

(5) The blood component storage container according to (4), wherein the phthalic acid diester is dinormal decyl phthalate and the dialkyl adipate is dioctyl adipate.

(6) The first plasticizer has 4 to 4 carbon atoms.
The blood component storage container according to any one of the above (1) to (5), which is an aliphatic or aromatic ester having at least two ester bonds containing an aliphatic hydrocarbon group of 12 hydrocarbon chains.

(7) The above-mentioned (6), wherein the first plasticizer is dialkyl phthalate or dialkyl adipate.
A blood component storage container according to claim 1.

(8) The blood component storage container according to any one of (1) to (5), wherein the first plasticizer is dioctyl phthalate.

(9) The content of the first plasticizer is 5 to 40.
The blood component storage container according to any one of the above (1) to (8), which is wt%.

(10) The content of the second plasticizer is 5 to 45.
The blood component storage container according to any one of the above (1) to (9), which is wt%.

(11) The blood component storage container according to any one of (1) to (10), wherein the total content of the first plasticizer and the second plasticizer is 20 to 50% by weight.

(12) A linked container comprising a plurality of containers including at least one blood component storage container according to any one of (1) to (11) connected by a tube.

[0023]

BEST MODE FOR CARRYING OUT THE INVENTION Hereinafter, a blood component storage container and a connected container of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.

FIG. 1 is a plan view showing an example of the configuration of a bag assembly according to the present invention. As shown in FIG.
Are a blood collection bag (first bag) 10, a plasma bag (second bag) 20, and a buffy coat bag (third bag).
Bag) 30 and chemical solution storage bag (fourth bag) 4
No. 0 is a quadruple bag in which each is connected by a predetermined tube.

The blood collection bag 10 located on the left side in FIG.
Constitutes a blood component storage container, a flexible sheet material made of polyvinyl chloride, which will be described later, is laminated, and fusion (heat fusion, high frequency fusion, or the like) is performed on the peripheral seal portion 12. Alternatively, it has a bag body 11 that is bonded and formed into a bag shape.

In the inside of the bag body 11 surrounded by the seal portion 12, a blood storage portion 1 for storing the collected blood is provided.
3 are formed. Further, since the blood collection bag 10 is also used as a red blood cell bag for storing red blood cells, the concentrated red blood cells are finally stored and stored in the blood storage unit 13.

In the upper part of the bag body 11, two openings 14 and 14 are formed, which are openably sealed by peel tabs. , 40 are formed. One end of a tube 61 is connected to the outlet 18 via a connecting member 17. Note that the connecting member 17 is preferably a member whose flow passage is closed before the breakage, but which opens the flow passage when the breakage occurs.

The other end of the tube 61 is connected to a branch connector 64 that branches into two branches.
4 are connected to one ends of tubes 62 and 63, respectively. A similar branch connector 19 is connected to the other end of the tube 62, and one ends of tubes 25 and 46 are connected to the branch connector, respectively.

Further, one end of a flexible tube 15 is connected to the upper part of the bag body 11 so as to communicate with the blood component storage unit 13, and the other end of the tube 15 is connected to the other end of the tube 15.
A blood collection needle 152 is mounted via a hub 151. The hub 151 has a cap 1 for enclosing the blood collection needle 152.
53 is mounted.

The plasma bag 20 is formed by laminating a flexible sheet material made of a soft resin such as polyvinyl chloride, which will be described later, and fusing (heat fusing, high frequency fusing, etc.) at the peripheral seal portion 22. Or, it has a bag body 21 which is bonded and formed into a bag shape.

A plasma storage portion 23 for storing plasma separated from blood in the blood collection bag 10 is formed in an inner portion of the bag body 21 surrounded by the seal portion 22.

In the upper part of the bag body 21, two blood transfusion outlets 2 which are opened and sealed by peel tabs are provided.
4 and 24 are formed, and the other end of the tube 25 is connected to the side thereof so as to communicate with the plasma storage unit 23. Thereby, when the flow path of the sealing member 17 is opened, the blood storage part 13 of the blood collection bag 10 and the plasma storage part 23 of the plasma bag 20 are connected by the sealing member 17, the tubes 61, 62,
5 and branch connectors 64 and 19.

The buffy coat bag 30 is formed by laminating a flexible sheet material made of a soft resin such as polyvinyl chloride to be described later.
A bag body 31 is formed by fusing (heat fusing, high-frequency fusing, or the like) or bonding to form a bag.

A buffy coat storage portion 33 for storing a buffy coat separated from the blood in the blood collection bag 10 is formed in an inner portion of the bag body 31 surrounded by the seal portion 32.

The other end of the tube 63 is connected to the upper part of the bag body 31 so as to communicate with the buffy coat storage section 33.

The chemical solution storage bag 40 is formed by laminating a flexible sheet material made of a soft resin such as polyvinyl chloride, which will be described later, and fusing (heat fusing, high-frequency fusing) at a sealing portion 42 on the periphery thereof. Etc.) or a bonded bag body 41 having a bag shape.

A chemical solution accommodating portion 43 for accommodating a chemical solution is formed in an inner portion surrounded by the seal portion 42 of the bag body 41. In the present embodiment, a predetermined amount of the red blood cell storage liquid 47 is stored in the liquid medicine storage section 43. Examples of the red blood cell preservation solution include M.P. A. P. Liquid, S.I. A.
G. FIG. M. Liquid, OPTISOL liquid, ADSOL liquid and the like.

In the upper part of the bag body 41, two outlets 44, 44 sealed so as to be opened by a peel tab are provided.
A sealing member 45 similar to the above is provided on a side portion thereof, which is communicated with the chemical solution storage portion 43. The other end of the tube 46 is connected to the sealing member 45. Thus, when the flow paths of the sealing members 17 and 45 are opened, the blood storage unit 13 of the blood collection bag 10, the chemical storage unit 43 of the chemical storage bag 40, the plasma storage unit 23 of the plasma bag 20, and the buffy coat bag 30 Buffy coat storage part 33 and sealing members 17 and 45, tube 6
1, 62, 63, 25, 46 and branch connector 64,
Each communicates with the other via a communication line 19.

It is preferable that an anticoagulant is put in the blood collection bag 10 in advance. This anticoagulant
Usually a liquid, for example, ACD-A liquid, CPD liquid, C
PDA-1 solution, heparin sodium solution and the like.
The amount of these anticoagulants is an appropriate amount according to the expected blood collection amount.

In the buffy coat bag 30,
A platelet preservation solution may be previously stored. Examples of the platelet preservation solution include physiological saline, GAC solution, PA
S solution, PSM-1 solution, Synthetic Storage Medium solution and the like.

Next, conditions and the like of the sheet material constituting each of the bags 10 to 40 will be described.

[1] Blood Collection Bag 10 The blood collection bag 10, which is the blood component storage container of the present invention, comprises a first plasticizer having a different composition in a soft polyvinyl chloride sheet material constituting the blood collection bag 10. And a second plasticizer, which suppresses hemolysis by a first plasticizer that elutes into a liquid (hereinafter, referred to as a preservation liquid) stored from the sheet material and a second plasticizer that elutes in a small amount. Effect (the effect of reducing the amount of hemoglobin leaking into the preservation solution), and the high gas permeability of the sheet material generated by the second plasticizer causes MA
The effect of suppressing the occurrence of erythrocytes and exerting these effects in a well-balanced manner makes it possible to obtain excellent blood cell storage properties.

The resin constituting the sheet material is polyvinyl chloride or a material mainly containing polyvinyl chloride (for example, a copolymer with a small amount of another polymer material, a polymer blend, a polymer alloy, etc.).

When the first plasticizer is blended alone in a polyvinyl chloride sheet at 32% by weight, a predetermined amount of a blood component is placed in a blood component storage container made of the polyvinyl chloride sheet at 35 ° C. at 35 ° C. It is soluble in blood components such that the level of dissolution of the plasticizer into blood components after storage for 15 days is 15 ppm or more.

This criterion is based on the relationship between the blending ratio of the plasticizer and the amount of elution (see FIG. 2) and the relationship between the amount of elution and the hemolysis rate described later (see FIG. 3), and di-2-ethylhexyl phthalate. (DEHP) as an example.

Such a first plasticizer has 4 to 1 carbon atoms.
At least 2 containing aliphatic hydrocarbon groups of 2 hydrocarbon chains
It is preferably an aliphatic or aromatic ester having two ester bonds, and more preferably dialkyl phthalate or dialkyl adipate.

Specific examples include dioctyl phthalate, dioctyl adipate, di-2-ethylhexyl phthalate, diisonoyl phthalate, isodecyl phthalate, di-2-ethylhexyl maleate, dibutyl phthalate, dihexyl phthalate and the like. These can be used alone or in combination of two or more. In particular, di-2-ethylhexyl phthalate (DEHP) is used because the elution amount is stable and the effect of suppressing hemolysis is high.
Or what mainly uses this is preferable.

The content of the first plasticizer in the sheet material is preferably about 5 to 40% by weight.
More preferably, it is about 30% by weight, and 10 to 25% by weight.
It is more preferable that the degree is about the same. If it is less than 5 wt%,
Since the amount of the first plasticizer eluted is small, there is a possibility that a sufficient hemolysis suppressing effect cannot be obtained. On the other hand, if it exceeds 40 wt%, the amount of elution will be excessive, which may affect the physiological activity of blood cells, and the mechanical strength of the bag will decrease, and the bag will be easily damaged during centrifugation or the like. is there.

On the other hand, when the second plasticizer is blended alone in the polyvinyl chloride sheet at 32 wt%, the oxygen gas permeability of the polyvinyl chloride sheet is 4.0 L / m ² · mm ·. d
ay · atm (30 ° C.) or more, preferably oxygen gas permeability of 4.2 L / m ² · mm · day · atm (30 ° C.) or more, and carbon dioxide gas permeability of 23.0 L / m ² · mm · day · atm (30
° C) or higher. In particular, when the second plasticizer is blended alone in the polyvinyl chloride sheet at 32 wt%, a predetermined amount of the blood component is placed in a blood component storage container made of the polyvinyl chloride sheet at 4 ° C. for 35 days. When stored, the level of dissolution of the plasticizer into blood components exceeds 2 ppm,
In addition, it is preferable that the first plasticizer has a dissolution level lower than that of the first plasticizer (slight dissolution).

Preferred examples of the second plasticizer having such properties include phthalic diesters, dialkyl phthalates, and adipic esters each having two or more aliphatic hydrocarbon groups having 4 to 12 carbon atoms. And dialkyl adipates. In this case, the diester phthalate is preferably dinormal decyl phthalate, and the dialkyl adipate is preferably dioctyl adipate.

In particular, a diester of phthalic acid and an alcohol or an aliphatic hydrocarbon group having 8 to 12 carbon atoms is preferable, and dinormal decyl phthalate (DnDP) or a main component thereof is more preferable. Further, among dioctyl adipates, di-2-ethylhexyl adipate (DEHA) is more preferable.

The content of the second plasticizer in the sheet material is preferably about 5 to 45% by weight.
More preferably, it is about 30% by weight, and 12 to 30% by weight.
It is more preferable that the degree is about the same. If it is less than 5 wt%,
The gas permeability of the sheet material decreases, and the effect of suppressing the generation of MA decreases. If the content exceeds 45 wt%, the total amount of the first plasticizer and the second plasticizer is limited (in order to maintain the mechanical strength of the sheet material). And the effect of suppressing hemolysis is reduced.

The second plasticizer in the present invention is slightly eluted in plasma, and therefore has the following advantages.

When the second plasticizer is non-elutable, only the first plasticizer is eluted, so that a large amount of the first plasticizer is required to sufficiently suppress hemolysis. However, as described later, in order to maintain the mechanical strength of the sheet material, the total amount of the first plasticizer and the second plasticizer is limited (for example, 50 wt% or less). Therefore, the respective amounts of the first plasticizer and the second plasticizer are subject to some restrictions.

On the other hand, when the second plasticizer is slightly eluted, the second plasticizer is eluted together with the first plasticizer. The same hemolysis suppressing effect can be obtained with the added amount of the agent, and therefore the added amount of the second plasticizer can be increased accordingly, so that more excellent gas permeability can be obtained. That is, while maintaining a certain mechanical strength of the sheet material, both the plasticizer elution amount and the gas permeability are improved, and the occurrence of hemolysis and MA can be effectively and well-balanced.

The total content of the first plasticizer and the second plasticizer is preferably about 20 to 50% by weight.
More preferably, it is about 40% by weight. If the total content is less than 20 wt%, at least one of the hemolysis suppressing effect and the MA generation suppressing effect may be insufficient, and if it exceeds 50 wt%, the mechanical strength (eg, tensile strength) of the sheet material. For example, when subjected to severe conditions such as centrifugation, the bag may be damaged.

In addition to the first and second plasticizers described above, various additives such as stabilizers may be added to the sheet material, if necessary. Examples of the stabilizer include various epoxy compounds and compounds of zinc, calcium, barium, and magnesium. The amount of the stabilizer in the sheet material is, for example, about 0.1 to 15 wt%.

The thickness of the sheet material is appropriately determined depending on the balance between mechanical strength and gas permeability required for the sheet material. It is more preferably about 0.25 to 0.4 mm.

The sheet material as described above can be manufactured, for example, by the following method. Using a kneader, the soft polyvinyl chloride and the first and second plasticizers are sufficiently kneaded, and the kneaded material is extruded through a T-die or a circular die. , Thermoforming, blowing, stretching, cutting, sealing of end portions (fusion), etc. are sequentially performed to process into a desired shape and form.

In order to prevent blocking between sheets, the surface of the sheet (substrate) may be roughened (embossed), or an anti-blocking agent, a slip agent, or the like may be added or provided.

[2] Platelet Bag The drug solution storage bag 40 can be used as a platelet bag for storing platelets after the red blood cell storage solution 47 is transferred to the blood storage unit 13 of the blood collection bag 10.

The composition, characteristics, and the like of the sheet material constituting the bag 40 are not particularly limited. For example, the same material as the sheet material in the blood collection bag 10 can be used. When the same material as the sheet material in the blood collection bag 10 is used, the number of types of sheet materials to be prepared is reduced, which is advantageous in production, and the elution of the plasticizer and the excellent gas permeability allow the platelet to be used. The storage stability is improved (for example, the effective storage period is 3 to 5 days).

[3] About Plasma Bag 20 The composition, characteristics, and the like of the sheet material constituting the plasma bag 20 are as follows.
There is no particular limitation, and for example, the same material as the sheet material in the blood collection bag 10 can be used. When the same material as the sheet material in the blood collection bag 10 is used, the types of sheet materials to be prepared are reduced, which is advantageous in manufacturing.

[4] Tubes 15, 61, 62, 63,
About 25, 46 As a constituent material of tubes 15, 61, 62, 63, 25, 46, for example, polyvinyl chloride, polyethylene,
Polypropylene, PET, polyester such as PBT, ethylene-vinyl acetate copolymer, polyurethane, polyester elastomer, thermoplastic elastomer such as styrene-butadiene-styrene copolymer or the like, or a material mainly containing these, Among them, polyvinyl chloride or a material mainly containing polyvinyl chloride is particularly preferred.

If each tube is made of polyvinyl chloride,
Since sufficient flexibility and flexibility can be obtained, it is easy to handle, and is suitable for blocking by cleansing or the like. Furthermore, since the tube made of polyvinyl chloride has excellent compatibility with the sheet material of the bag made of the same main material, when joining them by fusion or adhesion, the joining strength is high and the airtightness is excellent, It is preferable for maintaining durability against centrifugation and maintaining sterility. The type and content of the plasticizer used for each tube are not particularly limited.

It should be noted that, if the container-coupled body of the present invention has a blood cell storage container for storing a liquid containing a blood cell component, that is, a blood cell storage bag such as the above-described blood collection bag or red blood cell storage bag, it is not shown in the drawings. Not limited to the configuration,
For example, a double bag composed of a blood collection bag and a platelet bag, a triple bag composed of a blood collection bag, a plasma bag, and a platelet bag, a quadruple bag composed of a blood collection bag, a platelet bag, a plasma bag, and a dedicated red blood cell bag, and a red blood cell Blood collection bag, platelet bag,
Any bag may be used, such as a quadruple bag consisting of a plasma bag and a buffy coat bag (small bag for relaying), or a bag to which a bag for any use is added.

The container connected to the blood component storage container may be a bag made of the material mentioned as a constituent material of the tube or a container of another form.

[0068]

DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, specific embodiments of the present invention will be described.

(Examples 1, 2 and Comparative Examples 1 to 4)

A. experimental method

<1> Manufacture of a bag-coupled body Using a sheet having the composition and characteristics shown in Table 1 below, the sheets were overlapped and cut, and the peripheral portion was heat-sealed to produce a blood collection bag. Similarly, a platelet bag (drug storage bag), a plasma bag, and a buffy coat bag were manufactured.

Erythrocyte preservation solution (MAP solution / sodium chloride: 5.52 g / l, adenine: 0.16 g / l, glucose: 8.01) through a tube in a platelet bag (drug storage bag)
g / l, mannitol: 16.19 g / l, citric acid: 0.22 g /
l, sodium citrate: 1.67g / l, sodium phosphate:
Dispense 95 ml of an aqueous solution containing 1.04 g / l), connect each bag with a flexible tube, connect a blood collection tube to a blood collection bag, and pass an anticoagulant (ACD-A solution / quenched) through the tube. Aqueous solution containing sodium acid: 22.0 g / l, citric acid: 8.0 g / l, glucose: 22.0 g / l) 6
0 ml was dispensed to produce a four-bag connected body.

Next, the connected bag was subjected to high-pressure steam sterilization (121 ° C., 30 minutes). Table 2 below shows the configuration of each bag in the connected bag.

The tubes connecting each bag and the blood collection tube were made of soft polyvinyl chloride containing 36.7% by weight of di-2-ethylhexyl phthalate.

[0075]

[Table 1]

[0076]

[Table 2]

<2> Test of Heavy Metals and Dissolved Substances Heavy metals and dissolved substances were tested according to the standard (Japanese Pharmacopoeia General Test Method “Testing method for plastic containers for infusion”).

<3> Separation of Blood Components Approximately 400 ml of whole blood is stored in a blood collection bag, and the bag is centrifuged by a centrifugal separator. Separated.

Next, the platelet poor plasma in the blood collection bag was transferred to the plasma bag via the tube, and then the buffy coat was transferred to the buffy coat bag via the tube, leaving the concentrated red blood cells in the blood collection bag.

Next, the erythrocyte preservation solution previously placed in the platelet bag is transferred to the blood collection bag via a tube, and then a predetermined tube is sealed with a heat seal and cut, so that the erythrocyte preservation solution is added. It was separated into a blood collection bag containing concentrated red blood cells (red blood cell bag), a plasma bag containing platelet-poor plasma, and a combined bag of a buffy coat bag and a platelet bag containing buffy coat.

The buffy coat in the buffy coat bag was separated into an upper layer of concentrated platelets and a lower layer of white blood cells by slightly centrifuging the connected two-bag assembly.
The concentrated platelets were transferred to a platelet bag via a tube.

Finally, the tube connecting the platelet bag and the buffy coat bag was sealed and cut to separate them.

<4> Confirmation of MA Generation Status The blood collection bag containing the concentrated erythrocytes added with the erythrocyte preservation solution obtained in <3> above was stored at 4 ° C. for 35 days. Was observed (the results are shown in Table 3).

<5> Confirmation of hemolysis level The blood collection bag containing the concentrated erythrocytes added with the erythrocyte preservation solution obtained in <3> above was stored at 4 ° C. for 35 days. The solution after storage was aseptically sampled in 1 ml portions, and the hemoglobin concentration and hematocrit value in the sampled solution were measured with an automatic blood cell counting device (Sysmex CC-180, manufactured by Toa Medical Electronics Co., Ltd.).

A part of the sample solution taken out was centrifuged at 1500 centrifuges (KR-702, manufactured by Kubota Seisakusho).
G, and centrifuged for 10 minutes. The supernatant plasma was collected, and the hemoglobin concentration in the plasma was measured by the leuco crystal violet method (LCV method).

The measured values obtained as described above were substituted into the following equation, and the hemolysis rate was calculated (the results are shown in Table 3).

[0087]

(Equation 1)

<6> Confirmation of Preservation of Platelets The platelet bag containing the concentrated platelets obtained in <3> above was shake-preserved at 22 ° C., and on days 0, 3, and 5, 1 ml of each of the contents was aseptically added. The platelet count of the sampled and removed sample solution was measured by the automatic blood cell counting device (the results are shown in Table 4).

Further, the pH value (at3
7 ° C) with a blood gas / pH measurement device (Instrumentation Lab.
(IL 1304) (the results are shown in Table 5).

<7> Centrifugation Experiment A predetermined amount of distilled water was put into a blood collection bag, and centrifuged under the following conditions.

Centrifuge: Himac CR7B3, manufactured by Hitachi, Ltd. Conditions: 1.80 × 10 ⁸ g · sec, 4000 rpm (4.6
70G), 22 ° C

After centrifugation, the blood collection bag was taken out of the auxiliary cup and examined for damage (the results are shown in Table 6).

B. Experimental result

<1> Preparation of Sheets and Bags The preparation (adjustment) of sheets and the like was all performed smoothly, and a sheet with high uniformity was obtained. The production of each bag was also performed smoothly.

<2> Test Results of Heavy Metals and Leachables: In all the examples, it was confirmed that the heavy metals and the leachables also passed the standard (Japanese Pharmacopoeia General Test Method “Testing method for plastic containers for infusions”).

<3> Results of Evaluating Erythrocyte Preservation Table 3 below shows the occurrence of macroaggregates (MA) and hemolysis levels. As shown in Table 3, it was confirmed that in each of the blood collection bags of Examples 1 and 2, no MA was generated and the hemolysis level was low.

[0097]

[Table 3]

<4> Results of Evaluation of Platelet Preservation Table 4 below shows changes over time in platelet count, and Table 5 below shows changes over time in pH value. As shown in Table 4, there was almost no change in the platelet count in each case. Thus, under the condition that the platelet count is almost the same, as shown in Table 5, in Comparative Example 2, a decrease in pH value, which is considered to be caused by a low gas permeability, that is, a decrease in platelet quality However, in other cases, it was confirmed that storage could be performed almost stably for up to 5 days.

[0099]

[Table 4]

[0100]

[Table 5]

<5> Results of evaluation of bag strength by centrifugation experiment Table 6 below shows the number of breaks in the blood collection bags used in the centrifugation experiment. Each of the blood collection bags of Examples 1 and 2,
It was confirmed that there was no breakage and the strength was sufficient to withstand the centrifugation operation.

[0102]

[Table 6]

[0103]

As described above, according to the blood component storage container and the container connected body of the present invention, when the blood cell component is stored due to the appropriate elution of the plasticizer and the high gas permeability, the hemolysis of the blood cell component is achieved. And a function of suppressing the generation of macro aggregates (MA), and both of these functions are excellent.

In particular, when a slightly dissolving thing is used as the second plasticizer, the first plasticizer and the second plasticizer
When a predetermined more preferable composition is used, when the content of the first plasticizer, the content of the second plasticizer, or the total amount thereof is set in the above-described predetermined range, blood The above effects are more remarkably exhibited after securing sufficient mechanical strength in the component storage container, particularly strength that can withstand the centrifugation operation. For this reason, it is possible to store red blood cells and the like with high quality for a long period of time.

Further, the blood component storage container and the connected container of the present invention are easy to handle, easy to manufacture, and excellent in safety.

[Brief description of the drawings]

FIG. 1 is a plan view showing a configuration example of a connected container of the present invention.

FIG. 2 is a graph showing a relationship between a blending ratio of a plasticizer (DEHP) and an elution amount.

FIG. 3 is a graph showing the relationship between the elution amount of a plasticizer (DEHP) and the hemolysis rate.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Bag connected body 10 Blood collection bag 11 Bag main body 12 Seal part 13 Blood storage part 14 Discharge port 15 Tube 151 Hub 152 Blood collection needle 153 Cap 17 Sealing member 18 Discharge port 19 Branch connector 20 Plasma bag 21 Bag main body 22 Seal part 23 Plasma Storage section 24 Discharge port 25 Tube 30 Buffy coat bag 31 Bag body 32 Seal section 33 Buffy coat storage section 40 Chemical solution storage bag (platelet bag) 41 Bag body 42 Seal section 43 Chemical solution storage section 44 Discharge port 45 Sealing member 46 Tube 47 Erythrocyte preservation solution 61, 62, 63 Tube 64 Branch connector

──────────────────────────────────────────────────続 き Continuation of the front page (56) References JP-A-3-251252 (JP, A) JP-A-3-112561 (JP, A) JP-A-1-151459 (JP, A) JP-A-1- 104266 (JP, A) JP-A-61-257653 (JP, A) JP-A-5-305123 (JP, A) JP-T-59-501612 (JP, A) (58) Fields investigated (Int. ⁷ , DB name) A61J 1/10 A61J 3/00 300

Claims (12)

(57) [Claims] 1. A blood component storage container which is made of a soft polyvinyl chloride sheet containing a first plasticizer and a second plasticizer and stores a liquid containing at least a blood cell component, wherein: When the plasticizer is used alone in a polyvinyl chloride sheet at 32% by weight, a predetermined amount of a blood component is placed in a blood component storage container made of the polyvinyl chloride sheet at 4 ° C.
The second plasticizer is polyvinyl chloride, which is soluble in blood components such that the level of dissolution of the plasticizer into blood components is 15 ppm or more when stored for 35 days under the following conditions. When the polyvinyl chloride sheet is independently blended at 32 wt%, the oxygen gas permeability of the polyvinyl chloride sheet is 4.0 L / m ² · mm · day · atm (30 ° C).
A blood component storage container characterized by the above. 2. The method according to claim 1, wherein when the second plasticizer is independently blended into the polyvinyl chloride sheet at 32 wt%, a predetermined amount of the blood component is placed at 4 ° C. in a blood component storage container made of the polyvinyl chloride sheet. When the plasticizer elutes into the blood component at a level exceeding 2 ppm when stored for 35 days under
The blood component storage container according to claim 1, wherein the blood component storage container has a lower dissolution level than the plasticizer. 3. The second plasticizer is an aliphatic or aromatic ester having at least two ester bonds, including an aliphatic hydrocarbon group having at least 4 carbon atoms in each hydrocarbon chain. 3. The blood component storage container according to 1 or 2. 4. The second plasticizer has 4 carbon atoms each.
The blood component storage container according to claim 3, wherein the blood component storage container is a phthalic acid diester, a dialkyl phthalate, an adipic acid ester, or a dialkyl adipate having two or more aliphatic hydrocarbon groups of 1 to 12. 5. The blood component storage container according to claim 4, wherein the diester phthalate is dinormal decyl phthalate, and the dialkyl adipate is dioctyl adipate. 6. The first plasticizer is an aliphatic or aromatic ester having at least two ester bonds containing an aliphatic hydrocarbon group having a hydrocarbon chain of 4 to 12 carbon atoms. The blood component storage container according to any one of the above. 7. The blood component storage container according to claim 6, wherein the first plasticizer is a dialkyl phthalate or a dialkyl adipate. 8. The blood component storage container according to claim 1, wherein the first plasticizer is dioctyl phthalate. 9. The blood component storage container according to claim 1, wherein the content of the first plasticizer is 5 to 40% by weight. 10. The content of the second plasticizer is 5 to 45% by weight.
The blood component storage container according to any one of claims 1 to 9, wherein 11. The total content of the first plasticizer and the second plasticizer is 20 to 50% by weight.
The blood component storage container according to any one of the above. 12. A linked container comprising a plurality of containers each including at least one blood component storage container according to claim 1 connected by a tube.