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Manufacturing method of artificial preservation solution replacing platelet solution

A manufacturing method and technology for platelets, which are applied in chemical instruments and methods, blood filtration, and drug devices, etc., can solve the problems of discovery and hinting without separation methods, and achieve good quality results.

Active Publication Date: 2019-01-08
TORAY IND INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In any case, the object of filtration in the prior art is whole blood, and solutions that are prone to aggregation such as platelet preparations are not targeted
Furthermore, focusing only on membranes, there are no findings or hints about separation methods

Method used

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  • Manufacturing method of artificial preservation solution replacing platelet solution
  • Manufacturing method of artificial preservation solution replacing platelet solution
  • Manufacturing method of artificial preservation solution replacing platelet solution

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0169] As the separation membrane, a hollow fiber membrane formed of polysulfone and PVP was used.

[0170]A hollow fiber membrane module (separation membrane module for platelet solution) was produced from the hollow fiber membrane as follows. First, a bundle of 528 hollow fiber membranes obtained by the above-mentioned membrane production operation was inserted into a cylindrical plastic module of φ18×310 mm, immersed in a 60% by mass glycerin aqueous solution, and dried at 50° C. for a whole day and night. Next, 5 mL of a sealing material, which is a polyurethane resin, was injected into both ends of the plastic unit attached to the centrifuge, and rotated at 60 G / 15 minutes (first sealing). After these 15 minutes, 10 mL of sealing material was further injected into both ends of the plastic module, and rotated again at 60 G / 15 minutes (second sealing) to produce a hollow fiber membrane module.

[0171] The inner diameter of the hollow fiber membrane is 300μm, and the membr...

Embodiment 2

[0176] As the separation membrane, a hollow fiber membrane formed of polysulfone and PVP was used.

[0177] A hollow fiber membrane module (separation membrane module for platelet solution) was produced from the hollow fiber membrane as follows. First, a bundle of 50 hollow fiber membranes obtained by the above-mentioned membrane production operation was inserted into a cylindrical plastic module of φ10×220 mm, immersed in a 60% by mass glycerin aqueous solution, and dried at 50° C. overnight. Next, 0.5 mL of a sealing material, which is a polyurethane resin, was injected into both ends of the plastic unit attached to the centrifuge, and rotated at 60 G / 15 minutes (first sealing). After these 15 minutes, 1.7 mL of sealing material was further injected into both ends of the plastic module, and rotated again at 60 G / 15 minutes (second sealing) to produce a hollow fiber membrane module.

[0178] The inner diameter of the hollow fiber membrane is 300μm, and the membrane area is 0...

Embodiment 3

[0183] As the separation membrane, the same hollow fiber membrane formed of polysulfone and PVP as in Example 1 was used. In addition, a hollow fiber membrane module was fabricated in the same manner as in Example 1.

[0184] Using the produced hollow fiber membrane module, the platelet solution was filtered. Specifically, first, 52.2 mL of Meylon manufactured by Otsuka Pharmaceutical Co., Ltd., 126.8 mL of ACD-A solution manufactured by Terumo Corporation, and 3.2 mL of Mg sulfuric acid correction solution (1 mEq / ml) manufactured by Otsuka Pharmaceutical Co., Ltd. were added to 746.2 mL of SOLACET F manufactured by Terumo Corporation. and 71.6 mL of distilled water manufactured by Otsuka Pharmaceutical Co., Ltd. were mixed to prepare M-sol as an artificial preservation solution. In addition, the number of platelets in the original platelet solution is measured in advance.

[0185] For platelets containing 2.0 x 10 11 200 mL of platelet solution (platelet concentration is 1...

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Abstract

A new method for producing an artificial preservation fluid replacement platelet solution having platelet activation inhibiting properties, high platelet recovery properties and high plasma removal properties is disclosed. The method for producing a platelet solution replaced with an artificial preservation solution of the present invention comprises: under the conditions of the following formula 1, using a separation membrane with an average pore diameter of 0.1 μm or more and less than 2.0 μm on the surface in contact with the platelet solution, and using a separation membrane for 25 to 1500 s The inlet wall shear rate of ‑1 carries out cross-flow filtration on the aforementioned platelet solution to obtain the filtration step of the concentrated platelet solution; and the mixing step of mixing the aforementioned concentrated platelet solution with the artificial preservation solution to obtain the artificial preservation solution to replace the platelet solution, 1.0× 1011<(A×B) / (γ×μP)≦2.5×1013(unit / (hr･m2･Pa))・・・・Formula 1. A: Platelet concentration contained in the platelet solution (pieces / mL, of which, 8.0×107~200×107 pieces / mL); B: Filtration flow rate per unit area (mL / hr / m2); γ: Inlet wall shear rate (s‑1); μP: viscosity of platelet solution (Pa･s).

Description

technical field [0001] The invention relates to a manufacturing method of a platelet solution replaced by an artificial preservation solution. Background technique [0002] Blood donation for blood transfusion and production of blood preparations is broadly classified into whole blood donation and component blood donation. Various blood preparations are produced by separating blood collected through blood donation into components. Platelet preparation refers to a solution in which concentrated platelets are dispersed in plasma (mainly composed of protein and water). Since the concentration of platelets in platelet preparations is more than three times higher than that in whole blood, platelets may easily aggregate. [0003] Platelet preparations are used for blood transfusion for the prevention and treatment of bleeding in thrombocytopenia and thrombocytopenia. Existing platelet preparations are problematic due to allergic reactions such as hives and fever depending on th...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C12N5/078A61K35/19
CPCA61M1/34B01D61/147B01D2315/10B01D2325/36A61M2205/3306A61M2205/3331A61M2205/3334A61M1/3403A61M1/341A61K35/19B01D71/441B01D71/68
Inventor 岸川龙也长部真博上野良之岛垣昌明田中成宪林智也
Owner TORAY IND INC
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