JPH07323073A - Platelet bag and bag link body - Google Patents

Abstract

PURPOSE:To improve unbinding property of platelet along with a prolonged preservation of the platelet in high quality by forming a sheet material mainly composed of polyvinyl chloride containing a first plasticizer which is not eluted to blood components housed in substance and a second plasticizer which is eluted thereto in a shape of a bag. CONSTITUTION:In a platelet bag 10, flexible sheet materials made of polyvinyl chloride are laminated to be formed in a shape of a gab by fusion (thermal fusion, high frequency fusion or the like) or welding at a sealing part 11 on the periphery thereof. A platelet housing part 12 is formed at a part inside surrounded by sealing part 11 to house a platelet derived from blood which components are sampled. Two openings 13 each having a peeling tub are formed at an upper part of the bag and one end of a tube 16 flexible is connected therebetween communicating with the platelet housing part 12. The content of the first plasticizer in the sheet material is 30-50wt.% and moreover, preferably 30-41wt.%. The content of the second plasticizer in the sheet material is 1-4.9wt.% and moreover, preferably 2-4.5wt.%.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a platelet bag for storing and storing platelets and a bag assembly having the platelet bag.

[0002]

2. Description of the Related Art Currently, when performing blood transfusion, for the purpose of effective use of blood and reduction of the burden on the blood transfuse, the blood collected from the blood donor is separated into each component by centrifugation etc. Blood sampling is performed in which only the essential components are collected and the other components are converted to the donor.

In such component blood collection, a bag connecting body (multiple bags) in which a plurality of bags including a blood collecting bag are connected by a tube is used. Among the multiple bags, for example, a triple bag includes a blood collection bag (red blood cell storage / preservation bag), a plasma storage / preservation bag (hereinafter referred to as plasma bag), and a platelet storage / preservation bag (hereinafter referred to as platelet bag). Each of them is connected by a tube, and the blood collected in the blood collection bag is centrifuged to separate it into three layers of red blood cells, platelets (buffy coat) and plasma, and then the upper layer plasma and the intermediate layer platelets are respectively separated. Sequential transfer to a plasma bag and a platelet bag via a tube, leaving the underlying red blood cells in the blood collection bag.

A bag (for example, a platelet bag or a blood collection bag) containing necessary blood components (target blood product) is sealed, and other blood components are returned to the blood donor, and the bag is opened. The connected tube is cut and separated, and the bag containing the necessary blood component is collected and stored.

Each bag of such a bag connecting body is usually formed by forming a sheet material made of soft polyvinyl chloride into a bag shape. The reason for using soft polyvinyl chloride as a bag material is that it has flexibility to withstand centrifugal separation operation and heat resistance to withstand autoclave sterilization.

[0006] By the way, it is known that in a platelet bag for storing and storing platelets, the higher the gas permeability, the more the activity of the stored platelets is maintained, and a large number of platelets can be stored in a high quality state for a long period of time. Therefore, as a material for the sheet material constituting the platelet bag, a material using a polyolefin-based material has been developed. However, this polyolefin-made platelet bag has the following drawbacks.

When the platelets are stored in the platelet bag and then stored, the platelet bag is usually shaken to loosen the aggregates (pellets) of the platelets. Then, during this operation, since the platelets are not loosely loosened, it is necessary to further apply a mechanical shock to the platelets, which causes damage to the platelets in the initial stage of platelet storage, and eventually,
The shelf life of platelets is reduced.

If such a loosening operation is not carried out, it is necessary to remove the platelets in pellet form to adjust the platelet preparation, resulting in a loss of the number of platelets, and in addition, the platelets in platelet form (aggregated clumps). ) Takes time and effort, and there is a problem that sterility may be impaired.

[0009]

DISCLOSURE OF THE INVENTION An object of the present invention is to provide a platelet bag suitable for preserving high quality platelets for a long time and having an appropriate plasticizer elution property capable of improving the loosening property of the platelet, and the same. A bag connecting body having the same is provided.

[0010]

The above objects are achieved by the present invention described in (1) to (17) below.

(1) The sheet material is formed into a bag shape,
A platelet bag that stores and stores platelets inside,
The sheet material contains 30 to 50 wt% of a first plasticizer that does not substantially elute in the stored blood component and 1 to 4.9 wt% of a second plasticizer that elutes in the stored blood component. A platelet bag characterized by being made of a material mainly made of polyvinyl chloride.

(2) The platelet bag according to (1) above, wherein the first plasticizer is a diester of phthalic acid and an alcohol or an aliphatic hydrocarbon group having 9 to 12 carbon atoms in one molecule.

(3) The first plasticizer is di- (n-
The platelet bag and the bag connected body according to (1) above, which is decyl) phthalate.

(4) The platelet bag according to any one of (1) to (3) above, wherein the second plasticizer is dioctyl phthalate or dioctyl adipate.

(5) The second plasticizer is di- (2-
The platelet bag and the bag connected body according to any one of (1) to (3) above, which is ethylhexyl) phthalate.

(6) The total amount of the first and second plasticizers has a gas permeability of the sheet material which is equivalent to maintaining the pH of the platelets at 6 or more when the platelets are stored for at least 5 days. The platelet bag and the bag assembly according to any one of the above (1) to (5), which is an amount sufficient to obtain the platelet bag.

(7) The platelet bag according to any one of (1) to (6), wherein the total amount of the first and second plasticizers is 31 to 55 wt%.

(8) The platelet bag according to any one of (1) to (7) above, wherein the oxygen gas permeability coefficient of the sheet material is 2500 ml / m ² · mm · day · atm (30 ° C) or more.

(9) The platelet bag according to any one of (1) to (8) above, wherein the carbon dioxide permeability coefficient of the sheet material is 16000 ml / m ² · mm · day · atm (30 ° C) or more.

(10) A bag connecting body characterized in that the platelet bag according to any one of (1) to (9) above and at least one other bag are connected by a tube.

(11) The platelet bag according to any one of (1) to (9) and a red blood cell bag for storing and storing red blood cells are connected by a flexible tube. Connected bag.

(12) The bag connection body according to the above (11), wherein the red blood cell bag is also used as a blood sampling bag for storing blood collected.

(13) The red blood cell bag has a bag-shaped sheet material made of a material mainly composed of polyvinyl chloride containing a third plasticizer which is eluted into the blood component contained therein. The bag connected body according to the above (12), which is one.

(14) The third plasticizer is dioctyl phthalate or dioctyl adipate.
The platelet bag described in 3).

(15) The third plasticizer is di- (2-
The platelet bag and the bag connected body according to the above (13), which is ethylhexyl) phthalate or di- (2-ethylhexyl) adipate.

(16) The content of the third plasticizer is 1
The bag connection body according to any one of the above (13) to (15), which is ˜50 wt%.

(17) The tube is made of polyvinyl chloride or a material mainly containing polyvinyl chloride.
A bag connection body according to any one of (1) to (16).

[0028]

According to the research conducted by the present inventors, the above-described conventional polyolefin-made platelet bag is similar to the polyvinyl chloride plasticized with di-2-ethylhexyl phthalate, and can be applied to stored platelets. It was found that there was substantially no elution of the plasticizer, and therefore the loosening property of platelets was poor. However, conversely, when the amount of the plasticizer eluted into platelets during storage is too large, the activity (function) of platelets decreases, which is not suitable for long-term storage.

Therefore, according to the present invention, while satisfying the flexibility required for a polyvinyl chloride platelet bag, the elution amount of the plasticizer into platelets can be adjusted to an appropriate amount, that is, a necessary and sufficient amount. The characteristics and types of agents and their contents were found. Hereinafter, the platelet bag and the bag assembly of the present invention will be described in detail with reference to the preferred embodiments shown in the accompanying drawings.

FIG. 1 is a plan view showing a structural example of the platelet bag of the present invention. The platelet bag 10 shown in the figure is a platelet bag used for manufacturing and storing platelets derived from component blood collection. This platelet bag 10 is made by stacking polyvinyl chloride flexible sheet materials, which will be described later, and by fusing (heat fusing, high-frequency fusing, etc.) or bonding at a peripheral seal portion 11 to form a bag shape. It was done.

A platelet storage portion 1 in which platelets derived from component blood collection are stored in an inner portion surrounded by the seal portion 11.
2 is formed. Two openings 13, 13 with peel tabs are formed in the upper part of the platelet bag 10. Further, one end of a flexible tube 16 communicating with the platelet storage portion 12 is connected between the openings 13, 13.

FIG. 2 is a plan view showing a structural example of the platelet bag of the present invention. The platelet bag 10 shown in the figure is a platelet bag used for manufacturing and storing platelets derived from a single donor blood. In this platelet bag 10 as well, similarly to the above, a flexible sheet material made of polyvinyl chloride, which will be described later, is overlaid, and in the peripheral seal portion 11,
Fusing (heat fusion, high frequency fusion, etc.) or bonding to form a bag, and an inner portion surrounded by the seal portion 11
A platelet storage unit 12 for storing platelets derived from single donor blood sampling is formed. Then, the openings 13, 13 similar to those described above are formed, and the platelet storage unit 1 is provided between them.
One end of a flexible tube 16 communicating with 2 is connected.

The platelet bag 10 for platelets derived from single donor blood collection has a smaller volume of the platelet storage portion 12 than the platelet bag for platelets derived from component blood collection.

FIG. 3 is a plan view showing a constitutional example of the platelet bag of the present invention and a bag connecting body including the same. As shown in the figure, the bag connecting body 100 is the blood collection bag 1
Is a triple bag in which the platelet bag 10 and the plasma bag 30 are connected by flexible tubes.

The blood collecting bag 1 located on the right side in FIG.
A flexible sheet material made of resin, which will be described later, is superposed, and is fused (heat fusion, high-frequency fusion, etc.) or adhered to the peripheral seal portion 2 to form a bag.

In the inner part surrounded by the seal part 2,
A blood component storage unit 3 is formed. Blood component storage 3
Collects blood collected from the blood collecting needle 8 and passes through the tube 6, and finally corresponds to the lower layer of a plurality of blood components obtained by centrifuging the collected blood. Red blood cells are stored and stored. Therefore, the blood collection bag 1 is also used as a red blood cell bag.

Two openings 4 and 4 having peel tabs are formed in the upper portion of the blood collection bag 1, and an outlet 5 for connecting to another bag 10 or 30 is formed between them. ing. One end of a tube 14 is connected to the discharge port 5 via a connecting member 15. At the other end of the tube 14, a branch connector 21 that bifurcates.
Are connected. The flow path of the connecting member 15 is closed before breaking, but it is preferable to use a member that opens the flow path when breaking. Further, in the present invention, the connecting member 1
5 may not be provided, and in this case, it is preferable to appropriately close and release the tube 14 with a clamp or the like.

Further, one end of a flexible tube 6 is connected to the upper portion of the blood collection bag 1 so as to communicate with the blood component storage portion 3, and the other end of the tube 6 is connected to a blood collection via a hub 7. The needle 8 is attached. Further, a cap 9 that encloses the blood collection needle 8 is attached to the hub 7. In the blood component storage unit 3, for example, ACD liquid, CPD liquid, CP
A predetermined amount of an anticoagulant such as DA-1 solution or heparin sodium solution may be added in advance.

In the platelet bag 10 of the present invention located in the center of FIG. 1, flexible sheet materials made of polyvinyl chloride, which will be described later, are overlapped in the same manner as described above, and the peripheral seal portion 11 melts them. It is made into a bag shape by bonding (heat fusion, high frequency fusion, etc.) or bonding.

A platelet storage portion 12 for storing platelets (buffy coat, concentrated platelet plasma, etc.) separated from the blood in the blood collection bag 1 is formed in an inner portion surrounded by the seal portion 11. Two openings 13, 13 with peel tabs are formed in the upper part of the platelet bag 10.

Further, one end of a flexible tube 22 communicating with the platelet storage portion 12 is connected to the side portion of the opening portion 13, and the other end of the tube 22 is connected to one branch of the branch connector 21. Connected to the end. As a result, when the flow path of the connecting member 15 is opened, the blood component storage unit 3 of the blood collection bag 1 and the platelet storage unit 12 of the platelet bag 10 communicate with each other via the tubes 14 and 22 and the branch connector 21.

Plasma bag 30 located on the left side in FIG.
Is a flexible resin sheet described below,
The seal portion 31 at the periphery thereof is fused (thermal fusion, high frequency fusion, etc.) or adhered to form a bag.

A plasma storage portion 32 for storing plasma (particularly platelet poor plasma) separated from blood is formed in an inner portion surrounded by the seal portion 31. At the top of the plasma bag 30 are two openings 3 with peel tabs.
3, 33 are formed.

Further, one end of a flexible tube 24 communicating with the blood plasma storage section 32 is connected to a side portion of the opening 33, and the other end of the tube 24 branches to the other branch of the branch connector 21. Connected to the end. This allows
When the flow path of the connecting member 15 is opened, the plasma storage part 32 of the plasma bag 30 and the blood component storage part 3 and the platelet storage part 12 of the other bags 1 and 10 via the tubes 14, 22, 24 and the branch connector 21. Communicate with each other.

Next, the conditions of the sheet material constituting each bag 1, 10 and 30 will be described.

[Regarding Platelet Bag 10] The sheet material constituting the platelet bag 10 is a first plasticizer (non-eluting property) that does not substantially elute into the blood component (especially, concentrated platelet plasma) contained in the platelet container 12. Plasticizer) and polyvinyl chloride containing a second plasticizer (eluting plasticizer) that elutes in the blood component (especially concentrated platelet plasma) stored in the platelet storage unit 12 or a material mainly containing this ( It may be a polymer alloy with a small amount of other polymer materials).

Here, "substantially not eluted" means, for example, that when the concentrated red blood cells are stored for 35 days under the conditions of 4 ° C. and normal pressure, the amount eluted into the concentrated red blood cells is 10 ppm or less. The term "eluted" means that the amount eluted under the same conditions as described above exceeds 10 ppm.

Preferred examples of the first plasticizer include diesters of phthalic acid and alcohols or aliphatic hydrocarbons having 9 to 12 carbon atoms in one molecule. in this case,
Examples of the alcohol or aliphatic hydrocarbon having 9 to 12 carbon atoms include nonyl alcohol, decyl alcohol, undecyl alcohol and dodecyl alcohol. Of these, di- (n-decyl) phthalate (hereinafter referred to as "DnDP") is particularly preferable.

Suitable examples of the second plasticizer include dioctyl phthalate or dioctyl adipate,
Particularly, di- (2-ethylhexyl) phthalate (hereinafter referred to as "DEHP") is preferable.

The content of the first plasticizer as described above in the sheet material is 30 to 50 wt%, and further 30 to 41 wt%.
% Is preferred. If this content is less than 30 wt%, the total amount of the first and second plasticizers will be small, and the flexibility and gas permeability of the sheet material will be poor, and along with the decrease in gas permeability, the platelet preservability will be reduced. When the content exceeds 50 wt%, the total amount of the first and second plasticizers increases, which lowers the mechanical strength of the sheet material and causes breakage easily.

The content of the second plasticizer as described above in the sheet material is 1 to 4.9 wt%, and further 2 to 4.5 wt%.
% Is preferred. If this content is less than 1 wt%, the elution amount will be insufficient, and the looseness of the platelets cannot be sufficiently improved, and if it exceeds 4.9 wt%,
The elution amount becomes excessive, and the activity of stored platelets (aggregation ability, low osmotic shock recovery rate) decreases. The first plasticizer and the second plasticizer may be a mixture of two or more different kinds.

The total amount of the first plasticizer and the second plasticizer is such that when the platelets stored in the platelet storage section 12 are stored for at least 5 days, the pH of the platelets is 6 or more, particularly 6.5 or more. It is preferable that the amount is sufficient to obtain the gas permeability of the sheet material which is equivalent to the maintenance. Specifically, the total amount of the first plasticizer and the second plasticizer in the sheet material is 31%. 〜55wt%, 32〜55
wt% is more preferable, and further 34 to 46 wt%
Is preferred. If the total amount of plasticizer is less than 31 wt%,
The sheet material is inferior in flexibility and gas permeability.
If it exceeds wt%, the mechanical strength of the sheet material is lowered and the sheet is likely to be damaged.

The sheet material of the platelet bag 10 may further contain various additives such as stabilizers. Among these, examples of the stabilizer include various epoxy compounds, zinc, calcium, barium, magnesium or these compounds, and the addition amount in the sheet material is, for example, about 0.1 to 15 wt%. It

The better the gas permeability of the sheet material of the platelet bag 10, the better the preservability of platelets. That is, the oxygen gas permeability coefficient of the sheet material of the platelet bag 10 is preferably 2500 ml / m ² · mm · day · atm (30 ° C) or more, and 4500 ml / m ² · mm · day · atm (30 ° C). The above is more preferable.

The sheet material of the platelet bag 10 has a carbon dioxide permeability coefficient of 16000 ml / m ² · mm · day · atm (30 ° C).
It is preferably more than 28,000 ml / m ² · mm · day · atm
It is more preferable that the temperature is (30 ° C.) or higher.

The thickness of the sheet material of the platelet bag 10 is not particularly limited, but is preferably about 0.2 to 0.6 mm, more preferably about 0.25 to 0.5 mm.

[Blood Collection Bag 1] The sheet material constituting the blood collection bag 1 is preferably made of soft polyvinyl chloride, and is particularly eluted in blood or concentrated red blood cells stored in the blood component storage section 3. It is preferably composed of polyvinyl chloride containing a third plasticizer (eluting plasticizer) or a material mainly containing this (a polymer alloy with a small amount of another polymer material may be used). This is because the eluted plasticizer exerts a protective effect on the cell membrane of erythrocytes and thus improves the preservability of erythrocytes.

Suitable examples of the third plasticizer include dioctyl phthalate and dioctyl adipate,
In particular, di- (2-ethylhexyl) phthalate (DEH
P) or di-2-ethylhexyl adipate (DEH
A) is preferred. The third plasticizer is different from that of the second plasticizer.
You may use it in mixture of 1 or more types.

The content of such a third plasticizer in the sheet material is 1 to 50% by weight, preferably 20 to 40% by weight. If this content is less than 1 wt%,
The amount of elution is small and the effect of improving the preservability of red blood cells becomes insufficient. When it exceeds 50% by weight, the mechanical strength of the sheet material is lowered and the sheet material is easily damaged. Note that various additives may be added to the sheet material of the blood collection bag 1 as described above.

Although the thickness of the sheet material of the blood collection bag 1 is not particularly limited, it is preferably about 0.2 to 0.6 mm, more preferably about 0.27 to 0.5 mm.

[About plasma bag 30] Plasma bag 3
The sheet material forming 0 is not particularly limited, and the same material as that described in the red blood cell bag 1 can be used. When the sheet material is made of soft polyvinyl chloride, the type and addition amount of the plasticizer to be contained are not particularly limited, and for example, at least one of the first, second or third plasticizers may be 1 to About 55 wt% can be added.

The thickness of the sheet material of the plasma bag 30 is not particularly limited, but is preferably about 0.2 to 0.9 mm, more preferably about 0.3 to 0.6 mm.

Tubes 6, 14, 16, 22 and 24
Examples of the constituent material of polyvinyl chloride, polyethylene, polypropylene, PET, polyester such as PBT, ethylene-vinyl acetate copolymer, polyurethane, polyester elastomer, thermoplastic elastomer such as styrene-butadiene-styrene copolymer. Etc., or materials mainly composed of them, and among them, polyvinyl chloride or a material mainly composed of polyvinyl chloride is preferable. If each tube is made of polyvinyl chloride, sufficient flexibility and flexibility can be obtained, so that it is easy to handle, and it is suitable for clogging by a clamp or the like. Furthermore, since the polyvinyl chloride tube has excellent compatibility with the sheet material of the same main bag, when joining these by fusion or adhesion, the joining strength is high and the airtightness is excellent. It is preferable for maintaining durability against centrifugation and sterility. The type of plasticizer used in each tube and the content thereof are not particularly limited, and the above-mentioned additives may be added to the tube material.

The branch connector 21 is formed of a molded product of various resins such as polyvinyl chloride, polyethylene, polypropylene and polycarbonate.

The platelet bag of the present invention may be a single bag as shown in FIGS. 1 and 2, and any one or more other bags or other devices (for example, Chamber, needle tube, syringe, filter)
Etc. may be connected via a tube.

The bag connecting body of the present invention has the above-mentioned platelet bag, or the above-mentioned platelet and erythrocyte bag (blood collection bag),
The present invention is not limited to the configuration shown in the figure, and includes, for example, a double bag including a blood collecting bag and a platelet bag, a quadruple bag including a blood collecting bag, a platelet bag, a plasma bag, and a red blood cell bag, a blood collecting bag that also serves as a red blood cell bag, and a platelet bag. , Plasma bag and buffy coat bag (for relay)
The quadruple bag may be any bag such as a bag in which a bag for any purpose is added.

[0067]

EXAMPLES Hereinafter, the platelet bag and the bag assembly of the present invention will be described in more detail with reference to specific examples.

[1] A platelet bag (single bag) having the structure shown in FIG. 1 used for producing and storing component-derived blood platelets was produced.

Example 1 The sheet material of the platelet bag and other conditions are as follows.

Constituent material: Soft polyvinyl chloride Plasticizer: DnDP / 31.0 wt% DEHP / 3.1 wt% Total amount of plasticizer: 34.1 wt% Oxygen gas permeability coefficient: 4900 ml / m ² · mm · day · atm (30
(℃) (L-100, Dr.Lyssy, Zollikon, Switzerland same below) Carbon dioxide permeability coefficient: 30900 ml / m ² · mm · day · atm (30
℃) (L-100, Dr.Lyssy, Zollikon, Switzerland same below) Sheet material thickness: 0.32mm Bag capacity: 1000ml Bag surface area: 650cm ²

Example 2 The sheet material of the platelet bag and other conditions are as follows.

Constituent material: Soft polyvinyl chloride Plasticizer: DnDP / 30.7wt% DEHP / 3.4wt% Total amount of plasticizer: 34.1wt% Oxygen gas permeability coefficient: 4800ml / m ² · mm · day · atm (30
Carbon dioxide permeability coefficient: 30600 ml / m ² · mm · day · atm (30
℃) Sheet material thickness, bag internal volume and internal surface area: Example 1
same as

(Comparative Example 1) The sheet material of the platelet bag and other conditions are as follows.

Constituent material: Soft polyvinyl chloride Plasticizer: DnDP / 31.7 wt% Oxygen gas permeability coefficient: 5000 ml / m ² · mm · day · atm (30
Carbon dioxide permeability coefficient: 31800 ml / m ² · mm · day · atm (30
℃) Sheet material thickness, bag internal volume and internal surface area: Example 1
same as

(Comparative Example 2) The sheet material of the platelet bag and other conditions are as follows.

Constituent material: Soft polyvinyl chloride Plasticizer: DEHP / 31.7 wt% Oxygen gas permeability coefficient: 3100 ml / m ² · mm · day · atm (30
℃) Carbon dioxide permeability coefficient: 15800 ml / m ² · mm · day · atm (30
℃) Sheet material thickness, bag internal volume and internal surface area: Example 1
same as

(Comparative Example 3) The sheet material of the platelet bag and other conditions are as follows.

Constituent material: Soft polyvinyl chloride Plasticizer: DnDP / 23.0 wt% DEHP / 111.1 wt% Total amount of plasticizer: 34.1 wt% Oxygen gas permeability coefficient: 4000 ml / m ² · mm · day · atm (30
℃) Carbon dioxide permeability coefficient: 22,500 ml / m ² · mm · day · atm (30
℃) Sheet material thickness, bag internal volume and internal surface area: Example 1
same as

(Comparative Example 4) The sheet material of the platelet bag and other conditions are as follows.

Constituent material: Polyolefin film (without plasticizer) Oxygen gas permeability coefficient: 7500 ml / m ² · mm · day · atm (30
Carbon dioxide permeability coefficient: 30,000 ml / m ² · mm · day · atm (30
℃) Sheet material thickness: 0.25mm Bag capacity and internal surface area: same as in Example 1

[Operation Method] Examples 1 and 2 and Comparative Example 1
Platelets derived from component blood collection were collected as platelet-rich plasma (PRP) in each of the ~ 4 platelet bags. At this time, the number of platelets was about 3.0 × 10 ⁸ cells / ml, and the amount of PRP was about 50.
It was 0 ml.

Immediately after the collection of platelet-rich plasma, a centrifuge (CR7B3, manufactured by Hitachi Koki Co., Ltd.) was used to perform 5 at 2055G.
Centrifuged for minutes. A platelet bag and another bag having a capacity of 600 ml are aseptically connected to each other by using tubes for aseptic connection, and about 400 ml of supernatant plasma (PPP) in the platelet bag is transferred to the other bag. did. After the plasma (PPP) transfer was completed, the tube connecting both bags was fused and closed by a tube sealer, and the fused portion was cut and separated.

A platelet pellet (aggregate) was formed at the bottom of each platelet bag subjected to centrifugation.
The pellet was allowed to stand in an incubator at 22 ° C. for about 1 hour together with about 100 ml of plasma. Next, a shaking operation was performed to loosen the platelet pellets (aggregates) in each platelet bag and promote resuspension. Shaking was performed under the following conditions.

Apparatus: to-nd-ro flatbed shaker (HI-20, Thermonics Corporation, Tokyo, Japan) Shaking width: 40 mm Speed: 60 revolutions / minute Time: 5 consecutive days

[Observation and measurement]

A. Resuspension: 1, 3 and 5 days,
Each was visually observed and the number of remaining platelet pellets (aggregates) was counted and recorded.

B. Platelet quality: An operation adapter (made by Terumo Corp.) was attached to the outlet (opening 13) of each platelet bag, and shaking was continued. During this period, on days 0, 3 and 5, a syringe with an injection needle was used and the rubber portion of the operation adapter was pierced with the injection needle, and 1 ml of the content liquid was aseptically sampled. The following items were measured for this sampling solution (thick platelets).

Platelet count: automatic blood cell counter (Sysmex N
E-6000 Toa Medical Electronics Co., Ltd. ・ pH (37 ℃): Blood gas / pH measuring device (IL 1304 Instrumentation Lab., Milan, Italy) ・ Low osmotic shock recovery rate (% HSR): The operating procedure is as follows. 1-4

1. The concentrated platelet liquid (PC) was adjusted to a platelet count of 3.0 × 10 ⁵ / μl with fresh frozen plasma. 2. 0.4 ml of physiological saline or distilled water was added to 0.8 ml of the platelet solution. 3. Absorbance at a wavelength of 610 nm was measured for 15 minutes with a spectrophotometer (MPS-2000 manufactured by Shimadzu Corporation). 4. The% HSR was calculated from the formula shown below.

[0090]

[Equation 1]

Tables 1 to 4 below show the results of observation and measurement for each of the above items.

[0092]

[Table 1]

[0093]

[Table 2]

[0094]

[Table 3]

[0095]

[Table 4]

In Example 1, it can be said that there were no aggregates of platelets, that is, the resuspension state of platelets was good. Moreover, there is no particular change in the number of platelets over time. The degree of decrease in pH (37 ° C.) was small, and 7.0 was maintained even on the fifth day. Furthermore, the low osmotic shock recovery rate (% HSR) also shows a high value. From these,
It can be said that the storage condition (quality) of platelets was good.

In Example 2, it can be said that there were no platelet aggregates, that is, the resuspension state of platelets was good. Moreover, there is no particular change in the number of platelets over time. Further, the degree of decrease in pH (37 ° C) was small, and it was maintained at 7.0 or higher even on the 5th day. Furthermore, the low osmotic shock recovery rate (% HSR) also shows a high value. From these, the storage condition (quality) of platelets was the same as in Example 1,
It can be said that it was good.

In Comparative Example 1, there were aggregates of platelets, that is, the resuspension state of platelets was poor. The platelet count does not change with time. However, if resuspension is good, it is speculated that the platelet count has increased. And, the degree of decrease in pH (37 ° C) is small and 5
It was maintained at 7.0 or above on the first day. Furthermore, the low osmotic shock recovery rate (% HSR) also shows a high value.
From these, it can be said that the storage condition (quality) of platelets was good.

In Comparative Example 2, it can be said that there were no aggregates of platelets, that is, the resuspension state of platelets was good. Moreover, there is no particular change in the number of platelets over time. The degree of decrease in pH (37 ° C.) was larger than those in Examples 1 and 2 and less than 6.5. Furthermore, the low osmotic shock recovery rate (% HSR) also shows a low value. this is,
It is speculated that this is caused by the excessive elution of DEHP in the sheet material. From these, it was shown that the storage state (quality) of platelets was poor.

In Comparative Example 3, it can be said that there were no aggregates of platelets, that is, the resuspension state of platelets was good. Moreover, there is no particular change in the number of platelets over time. On the other hand, the degree of decrease in pH (37 ° C.) was the same as in Comparative Example 2,
It became big. Furthermore, the low osmotic shock recovery rate (% HSR) also shows a low value. It is speculated that this is due to the excessive elution of DEHP in the sheet material. From these, it was shown that the storage state (quality) of platelets was poor.

In Comparative Example 4, there was an aggregate of platelets, that is, the resuspension state of platelets was poor. The platelet count does not change with time. However, if resuspension is good, it is speculated that the platelet count has increased. And, the degree of decrease in pH (37 ° C) is small and 5
It was maintained at 7.0 or above on the first day. Furthermore, the low osmotic shock recovery rate (% HSR) also shows a high value.
From these, it can be said that the storage condition (quality) of platelets was good. As described above, it was only in Examples 1 and 2 that both the resuspension state and the platelet quality were good.

[2] A platelet bag having the structure shown in FIG. 2 used for producing and storing platelets derived from single-donor blood collection (bag collection) was manufactured.

Example 3 Sheet material thickness: 0.36 mm, bag capacity: about 400 m
l, surface area in bag: The same as Example 1 except that the surface area was 340 cm ² . In this case, the gas permeability of the sheet material is as follows.

Oxygen gas permeability coefficient: 4900 ml / m ² · mm · d
ay ・ atm (30 ℃) Carbon dioxide permeability coefficient: 30900ml / m ²・ mm ・ day ・ atm (30
℃)

Example 4 Sheet material thickness: 0.36 mm, bag capacity: about 400 m
l, surface area in bag: The same as Example 2 except that the surface area was 340 cm ² . In this case, the gas permeability of the sheet material is as follows.

Oxygen gas permeability coefficient: 4800 ml / m ² · mm · d
ay ・ atm (30 ℃) Carbon dioxide permeability coefficient: 30600ml / m ²・ mm ・ day ・ atm (30
℃)

(Comparative Example 5) Sheet material thickness: 0.36 mm, bag internal capacity: about 400 m
l, surface area in bag: Same as Comparative Example 1 except that the surface area was 340 cm ² . In this case, the gas permeability of the sheet material is as follows.

Oxygen gas permeability coefficient: 5000 ml / m ² · mm · d
ay ・ atm (30 ℃) Carbon dioxide permeability coefficient: 31800 ml / m ²・ mm ・ day ・ atm (30
℃)

(Comparative Example 6) Sheet material thickness: 0.36 mm, bag internal capacity: about 400 m
l, surface area in bag: Same as Comparative Example 2 except that the surface area was 340 cm ² . In this case, the gas permeability of the sheet material is as follows.

Oxygen gas permeability coefficient: 3100 ml / m ² · mm · d
ay ・ atm (30 ℃) Carbon dioxide permeability coefficient: 15800ml / m ²・ mm ・ day ・ atm (30
℃)

(Comparative Example 7) Sheet material thickness: 0.36 mm, bag internal capacity: about 400 m
l, internal surface area of bag: Same as Comparative Example 3 except that the surface area was 340 cm ² . In this case, the gas permeability of the sheet material is as follows.

Oxygen gas permeability coefficient: 4000 ml / m ² · mm · d
ay ・ atm (30 ℃) Carbon dioxide permeability coefficient: 22500ml / m ²・ mm ・ day ・ atm (30
℃)

(Comparative Example 8) Inner bag capacity: about 400 ml, inner bag surface area: 340 cm
^{The same} procedure as in Comparative Example 4 was performed except that the value was ² . In this case, the gas permeability of the sheet material is as follows.

Oxygen gas permeability coefficient: 7500 ml / m ² · mm · d
ay ・ atm (30 ℃) Carbon dioxide permeability coefficient: 30000ml / m ²・ mm ・ day ・ atm (30
℃)

[Procedure] From a single donor, a conventional method is used.
The platelet-rich plasma (PRP) obtained by
4, collected in each platelet bag of Comparative Examples 5-8 (overseas
According to the blood collection standard in
Serum). At this time, the number of platelets is about 3.2 × 10 ⁸ Pieces / m
The amount of l and PRP was about 250 ml.

Immediately after collecting the platelet-rich plasma, centrifugation was carried out at 2055 G for 5 minutes using the same centrifuge as described above. Platelet bag and other bag of 400ml capacity,
The tubes attached to them were aseptically connected by a tube aseptic connecting device, and about 200 ml of the supernatant plasma (PPP) in the platelet bag was transferred to the other bag.

After the transfer of plasma (PPP) was completed, the tube connecting both bags was fused and closed by a tube sealer, and the fused portion was cut and separated. A platelet pellet (aggregate) was formed at the bottom of each platelet bag subjected to centrifugation. This pellet was allowed to stand in an incubator at 22 ° C. for about 1 hour together with about 50 ml of plasma.

Next, in order to loosen the platelet pellets (aggregates) in each platelet bag and promote resuspension, a shaking operation was performed under the same conditions as above, and observation and measurement were performed in the same manner as above. The results are shown in Tables 1 to 4 above.

In Example 3, it can be said that there were no platelet aggregates, that is, the resuspension state of platelets was good. Moreover, there is no particular change in the number of platelets over time. The degree of decrease in pH (37 ° C.) was small, and 7.0 was maintained even on the fifth day. Furthermore, the low osmotic shock recovery rate (% HSR) also shows a high value. From these,
It can be said that the storage condition (quality) of platelets was good.

In Example 4, it can be said that there were no aggregates of platelets, that is, the resuspension state of platelets was good. Moreover, there is no particular change in the number of platelets over time. Further, the degree of decrease in pH (37 ° C) was small, and it was maintained at 7.0 or higher even on the 5th day. Furthermore, the low osmotic shock recovery rate (% HSR) also shows a high value. From these, the storage state (quality) of platelets was the same as in Example 3,
It can be said that it was good.

In Comparative Example 5, there was an aggregate of platelets, that is, the resuspension state of platelets was poor. The platelet count does not change with time. However, if resuspension is good, it is speculated that the platelet count has increased. And, the degree of decrease in pH (37 ° C) is small and 5
It was maintained at 7.0 or above on the first day. Furthermore, the low osmotic shock recovery rate (% HSR) also shows a high value.
From these, it can be said that the storage condition (quality) of platelets was good.

In Comparative Example 6, it can be said that there were no platelet aggregates, that is, the resuspension state of the platelets was good. Moreover, there is no particular change in the number of platelets over time. On the other hand, the degree of decrease in pH (37 ° C.) was larger than in Examples 3 and 4, and was less than 6.5. Furthermore, the low osmotic shock recovery rate (% HSR) also shows a low value. It is speculated that this is due to the excessive elution of DEHP in the sheet material. From these, it was shown that the storage state (quality) of platelets was poor.

In Comparative Example 7, it can be said that there were no platelet aggregates, that is, the resuspended state of platelets was good. Moreover, there is no particular change in the number of platelets over time. On the other hand, the degree of decrease in pH (37 ° C.) was the same as in Comparative Example 6,
It became big. Furthermore, the low osmotic shock recovery rate (% HSR) also shows a low value. It is speculated that this is due to the excessive elution of DEHP in the sheet material. From these, it was shown that the storage state (quality) of platelets was poor.

In Comparative Example 8, there was an aggregate of platelets, that is, the resuspension state of platelets was poor. The platelet count does not change with time. However, if resuspension is good, it is speculated that the platelet count has increased. And, the degree of decrease in pH (37 ° C) is small and 5
It was maintained at 7.0 or above on the first day. Furthermore, the low osmotic shock recovery rate (% HSR) also shows a high value.
From these, it can be said that the storage condition (quality) of platelets was good. As described above, it was only in Examples 3 and 4 that both the resuspension state and the platelet quality were good.

[3] A bag connected body (triple bag) having the structure shown in FIG. 3 was prepared by connecting a blood collection bag (erythrocyte bag), a platelet bag and a plasma bag with a predetermined tube. The conditions of each bag are as follows.

(Example 5) Platelet bag Same as Example 3.

Red blood cell bag Constituent material: Soft polyvinyl chloride Plasticizer: DEHP / 31.7 wt% Oxygen gas permeability coefficient: 3100 ml / m ² · mm · day · atm (30
℃) Carbon dioxide permeability coefficient: 15800 ml / m ² · mm · day · atm (30
℃) Sheet material thickness: 0.36mm Bag capacity: 500ml Bag surface area: 380cm ²

Plasma bag Constituent material: Soft polyvinyl chloride Plasticizer: DEHP / 31.7wt% Sheet material thickness: 0.36mm Bag capacity: about 400ml Bag surface area: 340cm ²

Connection tube Soft polyvinyl chloride (Plasticizer: DEHP36.7wt%)

(Example 6) Platelet bag Same as Example 4.

Red blood cell bag, plasma bag,
Connection tubes are the same as in Example 5

Comparative Example 9 Platelet Bag Same as Comparative Example 5

Red blood cell bag Constituent material: Soft polyvinyl chloride Plasticizer: DnDP / 31.7 wt% Oxygen gas permeability coefficient: 5000 ml / m ² · mm · day · atm (30
Carbon dioxide permeability coefficient: 31800 ml / m ² · mm · day · atm (30
℃) Sheet material thickness: 0.36mm Bag capacity: 500ml Bag surface area: 380cm ²

Plasma bag Constituent material: Soft polyvinyl chloride Plasticizer: DnDP / 31.7wt% Sheet material thickness: 0.36mm Bag capacity: about 400ml Bag surface area: 340cm ²

Connection tube Same as in Example 5

Comparative Example 10 Platelet Bag Same as Comparative Example 6

Red blood cell bag, plasma bag,
Connection tubes are the same as in Example 5

Comparative Example 11 Platelet Bag Same as Comparative Example 7

Red blood cell bag, plasma bag,
Connection tubes are the same as in Example 5

Comparative Example 12 Platelet Bag Same as Comparative Example 8

Red blood cell bag, plasma bag,
Connection tubes are the same as in Example 5

[Operation Method (in the case of collecting 450 ml of blood)] Using the bag joints of Examples 5 and 6 and Comparative Examples 9 to 12, concentrated platelets and concentrated red blood cells were collected from the blood collected from the donor.

First, a donor needle was punctured into a vein of a donor, and 450 ml of blood (standard for collecting blood overseas) was collected in a blood collecting bag through a tube. Then, the middle of the tube was fused with a tube sealer and further cut.

Using the same centrifuge as described above, the connected bag was centrifuged at 1100 G for 6 minutes, the connecting member (Terumo Co., Click Tip) was opened, and blood was collected by a separation stand. By pressing the bag, the upper platelet-rich plasma (PRP) in the blood collection bag was transferred to the platelet bag, and red blood cells (CRC) were left in the blood collection bag. At this time, the platelet-rich plasma (PR
As for P), the platelet count is about 3.2 × 10 ⁸ cells / ml,
The amount of PRP was about 250 ml.

Further, after closing a predetermined portion of the tube with a clamp, the same centrifuge as described above was used to re-close the tube again.
After centrifugation at 55 G for 5 minutes, about 200 ml of the supernatant plasma (PPP) in the platelet bag was transferred to the plasma bag. Then, the tubes attached to the respective bags were fused by a tube sealer, cut and separated.

A platelet pellet (aggregate) was formed at the bottom of each platelet bag subjected to centrifugation.
This pellet is mixed with about 50 ml of plasma at 22 ° C for about 1
It was left standing in the time incubator. Next, in order to loosen the platelet pellets (aggregates) in each platelet bag and promote resuspension, a shaking operation was performed under the same conditions as above, and observation and measurement were performed.

[Observation and measurement]

A. Resuspended state and B. Each item of platelet quality was the same as above.

C. Erythrocyte quality: An operation adapter (made by Terumo Corp.) was attached to the outlet (opening 33) of each erythrocyte bag and allowed to stand at 4 ° C. After storage for 5 weeks, a syringe with an injection needle was used to pierce the rubber portion of the operation adapter with the injection needle, and 1 ml of the content liquid was aseptically sampled. About this sampling liquid (concentrated red blood cells), using an automatic blood cell counter (Sysmex NE-6000 manufactured by Toa Medical Electronics Co., Ltd.),
The hemoglobin concentration and hematocrit value were measured.
Further, a part of the sampling solution was centrifuged at 1500 G for 10 minutes using the same centrifuge as described above, and the supernatant plasma was collected, and the cyanmethemoglobin method (hemoglobin-
The hemoglobin concentration in plasma was measured by Test Wako, manufactured by Wako Pure Chemical Industries, Ltd.). The hemolysis rate was obtained by substituting each data obtained as described above into the formula shown in the following Expression 2.

[0150]

[Equation 2]

Tables 5 to 9 below show the results of observation and measurement for each of the above items.

[0152]

[Table 5]

[0153]

[Table 6]

[0154]

[Table 7]

[0155]

[Table 8]

[0156]

[Table 9]

In Example 5, it can be said that there were no platelet aggregates, that is, the resuspension state of platelets was good. Moreover, there is no particular change in the number of platelets over time. The degree of decrease in pH (37 ° C.) was small, and 7.0 was maintained even on the fifth day. Furthermore, the low osmotic shock recovery rate (% HSR) also shows a high value. From these,
It can be said that the storage condition (quality) of platelets was good. In addition, it can be said that the hemolysis rate was low and the storage condition (quality) of red blood cells was good. It is speculated that this is because the erythrocyte membrane protective action was exhibited by the elution of the plasticizer DEHP.

In Example 6, it can be said that there were no aggregates of platelets, that is, the resuspension state of platelets was good. Moreover, there is no particular change in the number of platelets over time. Further, the degree of decrease in pH (37 ° C) was small, and it was maintained at 7.0 or higher even on the 5th day. Furthermore, the low osmotic shock recovery rate (% HSR) also shows a high value. From these, the storage state (quality) of platelets was the same as in Example 5,
It can be said that it was good. In addition, it can be said that the hemolysis rate was low and the storage condition (quality) of red blood cells was good. It is speculated that this is because the erythrocyte membrane protective action was exhibited by the elution of the plasticizer DEHP.

In Comparative Example 9, there were aggregates of platelets, that is, the resuspension state of platelets was poor. The platelet count does not change with time. However, if resuspension is good, it is speculated that the platelet count has increased. And, the degree of decrease in pH (37 ° C) is small and 5
It was maintained at 7.0 or above on the first day. Furthermore, the low osmotic shock recovery rate (% HSR) also shows a high value.
From these, it can be said that the storage condition (quality) of platelets was good. In addition, the hemolysis rate was high, and the storage condition (quality) of red blood cells was inferior to the others. This is a plasticizer DnDP
It is presumed that this is due to the non-eluting property, and the above-mentioned protective action of the red blood cell membrane was not obtained.

In Comparative Example 10, it can be said that there were no aggregates of platelets, that is, the resuspension state of platelets was good. Moreover, there is no particular change in the number of platelets over time.
The degree of decrease in pH (37 ° C.) was larger than those in Examples 5 and 6 and was less than 6.5. Furthermore, the low osmotic shock recovery rate (% HSR) also shows a low value. It is speculated that this is due to the excessive elution of DEHP in the sheet material. From these, the storage condition (quality) of platelets is
It was shown to be bad. In addition, it can be said that the hemolysis rate was low and the storage condition (quality) of red blood cells was good. It is speculated that this is because the erythrocyte membrane protective action was exhibited by the elution of the plasticizer DEHP.

In Comparative Example 11, it can be said that there were no platelet aggregates, that is, the resuspension state of platelets was good. Moreover, there is no particular change in the number of platelets over time.
Then, the degree of decrease in pH (37 ° C.) was large, as in Comparative Example 10. Furthermore, the low osmotic shock recovery rate (% HSR) also shows a low value. It is speculated that this is due to the excessive elution of DEHP in the sheet material. From these, it was shown that the storage state (quality) of platelets was poor. On the other hand, the hemolysis rate was low, and it can be said that the storage state (quality) of red blood cells was good. It is speculated that this is because the erythrocyte membrane protective action was exhibited by the elution of the plasticizer DEHP.

In Comparative Example 12, there is an aggregate of platelets,
That is, the resuspension state of platelets was poor. Also,
The platelet count does not change over time. However, if resuspension is good, it is speculated that the platelet count has increased. On the other hand, the decrease in pH (37 ° C) is small, and
It was maintained at 7.0 or above on the first day. Furthermore, the low osmotic shock recovery rate (% HSR) also shows a high value.
From these, it can be said that the storage condition (quality) of platelets was good. In addition, it can be said that the hemolysis rate was low and the storage condition (quality) of red blood cells was good. This is a plasticizer DE
It is speculated that this is because the protective action of the red blood cell membrane was exerted by the elution of HP. As described above, the reason why platelet resuspension state, platelet quality and red blood cell quality are all good is
Only in Examples 5 and 6.

Examples 7 to 10 Platelets bags similar to those in Examples 1 to 4 were prepared except that the plasticizer DEHP in the sheet material of the platelet bag was replaced with di- (2-ethylhexyl) adipate. When the same operation, observation and measurement were performed, almost the same result was obtained.

(Examples 11 and 12) The plasticizer DEHP in the sheet material of the erythrocyte bag was treated with di- (2-ethylhexyl).
Example 5 and 6 except that the adipate was used instead.
When a bag connected body similar to the above was prepared and the same operation, observation and measurement were performed, almost the same result was obtained.

[0165]

As described above, according to the platelet bag and the bag connecting body of the present invention, the sheet material of the platelet bag has appropriate flexibility, strength capable of withstanding centrifugal operation, and durability. And, because it has sufficient gas permeability, platelets are in high quality for a long time (for example, about 5 to 7 days).
It becomes possible to save.

Further, since the plasticizer is appropriately eluted from the sheet material and mixed into the stored and stored platelets, the looseness during the preparation of the platelets is improved without lowering the quality (activity) of the platelets. be able to. As a result, the platelet disassembling operation is not troublesome, the mechanical shock applied to the platelets during the disassembling operation is small, and the operation for removing the aggregates is not required, and there is no loss in the number of platelets. It can be manufactured well.

In particular, the insoluble first plasticizer is
When a diester of phthalic acid and an alcohol having 9 to 12 carbon atoms in one molecule or an aliphatic hydrocarbon group, such as (n-decyl) phthalate, or a dilutable second plasticizer is used as a diester. When dioctyl phthalate such as-(2-ethylhexyl) phthalate or dioctyl adipate is used, and when the total amount of both plasticizers is adjusted to a desired value, the above effect becomes remarkable.

Further, in the bag assembly of the present invention, when the sheet material of the red blood cell bag contains the third plasticizer having the elution property, the hemolysis of the stored red blood cells is suppressed, and the red blood cells are kept in high quality and long. It becomes possible to save for a period.

In this case, when the third plasticizer is dioctyl phthalate such as di- (2-ethylhexyl) phthalate or dioctyl adipate such as di- (2-ethylhexyl) adipate, the content thereof is further increased. Is 1 to 50 wt%, the storage stability of red blood cells is further improved.

Further, when the tubes connecting the bags are made of the same material as the sheet material of those bags, the bondability between the bag and the tubes is improved, and the airtightness and sterilization of the joints are improved. High retention.

[Brief description of drawings]

FIG. 1 is a plan view showing a configuration example of a platelet bag of the present invention used for manufacturing and storing platelets derived from component blood collection.

FIG. 2 is a plan view showing a configuration example of a platelet bag of the present invention used for manufacturing and storing platelets derived from a single donor blood collection.

FIG. 3 is a plan view showing a configuration example of a platelet bag and a bag connected body of the present invention.

[Explanation of symbols]

 1 Blood collection bag 2 Seal part 3 Blood component storage part 4 Opening part 5 Discharge port 6 Tube 7 Hub 8 Blood collection needle 9 Cap 10 Platelet bag 11 Seal part 12 Platelet storage part 13 Opening part 14 Tube 15 Coupling member 16 Tube 21 Branch connector 22 , 24 tubes 30 plasma bag 31 seal part 32 plasma storage part 33 opening part 100 bag connected body

Claims (17)

[Claims] 1. A platelet bag in which a sheet material is formed in a bag shape and stores and stores platelets therein, wherein the sheet material is a first plastic material that does not substantially elute into the stored blood component. Platelet bag characterized in that it is composed of a material mainly containing polyvinyl chloride containing 30 to 50 wt% of the agent and 1 to 4.9 wt% of the second plasticizer that is eluted into the stored blood component. . 2. The platelet bag according to claim 1, wherein the first plasticizer is a diester of phthalic acid and an alcohol or an aliphatic hydrocarbon group having 9 to 12 carbon atoms in one molecule. 3. The platelet bag and the bag connected body according to claim 1, wherein the first plasticizer is di- (n-decyl) phthalate. 4. The platelet bag according to claim 1, wherein the second plasticizer is dioctyl phthalate or dioctyl adipate. 5. The platelet bag and the bag connected body according to claim 1, wherein the second plasticizer is di- (2-ethylhexyl) phthalate. 6. The total amount of the first and second plasticizers is
When platelets are stored for at least 5 days,
The platelet bag and the bag assembly according to any one of claims 1 to 5, wherein the amount is sufficient to obtain gas permeability of the sheet material corresponding to maintaining pH of 6 or more. 7. The total amount of the first and second plasticizers is
The platelet bag according to any one of claims 1 to 6, which is 31 to 55 wt%. 8. The oxygen gas permeability coefficient of the sheet material is 2
The platelet bag according to any one of claims 1 to 7, which has a volume of 500 ml / m ² · mm · day · atm (30 ° C) or more. 9. The carbon dioxide permeability coefficient of the sheet material is 1
It is 6000 ml / m ² · mm · day · atm (30 ° C) or more.
The platelet bag according to any one of 1 to 8. 10. A bag connecting body comprising the platelet bag according to claim 1 and at least one other bag connected by a tube. 11. A bag connecting body, wherein the platelet bag according to claim 1 and a red blood cell bag for storing and storing red blood cells are connected by a flexible tube. . 12. The red blood cell bag is also used as a blood collection bag for storing blood collected.
The bag connected body according to 1. 13. The red blood cell bag is a bag-shaped sheet material made of a material mainly containing polyvinyl chloride containing a third plasticizer which is eluted into blood components contained in the red blood cell bag. The bag connecting body according to claim 12, wherein 14. The platelet bag according to claim 13, wherein the third plasticizer is dioctyl phthalate or dioctyl adipate. 15. The platelet bag and the bag connected body according to claim 13, wherein the third plasticizer is di- (2-ethylhexyl) phthalate or di- (2-ethylhexyl) adipate. 16. The content of the third plasticizer is 1 to 5
It is 0 wt%, The bag connection body in any one of Claim 13 thru | or 15. 17. The bag connecting body according to claim 10, wherein the tube is made of polyvinyl chloride or a material mainly containing polyvinyl chloride.