JP2002174633A - How to store serum - Google Patents

Abstract

(57) [Problem] To provide a serum that can be stored for a long time without adding a preservative or freezing. SOLUTION: The gas dissolved in the serum is degassed, and the degassed serum is sealed and stored.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method for preserving serum used for treating diseases and injuries and for calibrating test equipment in clinical tests.

[0002]

2. Description of the Related Art For example, in the case of a liquid serum used for calibrating a test device when performing a clinical test (this is called a control serum), whether or not the test is performed normally, in other words, An important issue is whether the control serum or the standard serum for determining the test is accurate as a standard calibration solution. However, as a practical matter, not only serum for administration but also liquid serum used for treatment of diseases and injuries, unless properly preserved, is liable to deteriorate in quality due to deterioration such as decay, oxidation and the like. Enzymes such as LDH (lactate dehydrogenase), CK (creatine kinase), and ALP (alkaline phosphatase), and serum proteins such as lipoproteins, which are susceptible to oxidation or other denaturation, are difficult to stabilize. There is a problem that it is difficult to store for a long period (1-2 years or more).

[0003] Therefore, conventionally, a preservative such as sodium azide has been added for the purpose of preventing spoilage of serum, or for the purpose of preventing the oxidation of enzymes, lipoproteins and other proteins in serum, which is susceptible to oxidative deterioration, and other denaturation. A freezing treatment or freeze-drying treatment at -80 ° C was performed. However, the addition of preservatives is limited to serum for administration that is not used directly on the human body.Frozen treatment or freeze-drying treatment requires not only large facilities but also freezing treatment when used. Deterioration when thawing the serum was inevitable. In addition, although it is desirable to carry out the calibration work of the testing equipment in the clinical test immediately before the test, it cannot be heated and defrosted, so that it takes a long time to defrost and there is a problem that a work loss occurs in the test. Furthermore, although the control serum is relatively expensive, the one that has been thawed and opened once deteriorates immediately, which necessitates disposal, resulting in an increase in cost. Therefore, it has been desired to provide a serum that can be stored for a long period of time without adding a preservative or freezing treatment, and that can be subjected to a calibration work immediately before an inspection.

[0004]

SUMMARY OF THE INVENTION The present inventors have conducted intensive studies in order to meet such a demand, and found that the storage period of the serum is such that the enzymes and lipoproteins contained therein are denatured by oxidation and the like. Based on the finding that oxidation or other denaturation of enzymes, lipoproteins, etc. can be suppressed by removing gas such as oxygen dissolved in liquid serum, Invented the invention. Lipoproteins are also affected by enzymes such as LDL (low-density lipoprotein), and have been found to suppress the activation of these enzymes.
An object of the present invention is to provide a method for storing serum capable of storing serum for a long period of time without adding a preservative or freezing.

[0005]

The serum preservation method of the present invention that achieves the above object has been developed in order to prevent the serum proteins contained in the serum from deteriorating due to oxidation. Degas to remove gases such as oxygen gas,
The degassed serum is sealed and stored (claim 1). Several degassing methods for removing gas such as oxygen gas dissolved in serum are conceivable.However, the serum is brought into contact with a permeable membrane that allows only gas to pass through and prevents liquid permeation, and passes the serum through the permeable membrane. It is preferable that the dissolved gas is degassed from, and the degassed serum is sealed and stored in a storage container (claim 2). At this time, a permeable membrane for passing only gas and preventing the permeation of the liquid is formed in a hollow tube shape or a flat membrane shape, and the permeable membrane is set in a decompression container, and the permeation is performed by reducing the pressure in the decompression container. Preferably, the dissolved gas is degassed from the serum through the membrane (claim 3). Further, when a permeable membrane that allows only gas to pass therethrough and blocks liquid permeation is installed in the decompression container, the permeable membrane may be used also as the storage container (claim 4).

[0006]

DESCRIPTION OF THE PREFERRED EMBODIMENTS Preferred embodiments of the present invention will be described below in detail with reference to the drawings, but the present invention is not limited to these embodiments.

[0007] Reference numeral 1 in the figure denotes a container for storing serum before being sealed in the storage container 2, and the liquid serum stored in the container 1 is set in the decompression container 3. Contacting a permeable membrane 4 that allows only gas to pass through and blocks liquid permeation;
By reducing the pressure in the decompression container 3, gases such as oxygen gas dissolved in the serum are removed through the permeable membrane 4 and degassed.

The decompression container 3 is for efficiently degassing dissolved gas from the serum in contact with the permeable membrane 4. A permeable membrane 4 that allows only gas to pass therethrough and blocks liquid permeation is installed inside.

The permeable membrane 4 is for separating (degassing) the serum and the dissolved gas by directly contacting the liquid serum and selectively permeating the dissolved gas dissolved in the serum. There is no restriction on the material, whether porous or non-porous, as long as it has the property of passing only gas and preventing liquid permeation. It is preferable to use a synthetic resin or inorganic film material through which only gas molecules selectively permeate so as not to come. Specifically, a fluorine-based resin material or a silicon-based resin material, more specifically, a tetrafluoroethylene-based resin polymer that is a fluorine-based resin material, for example, polytetrafluoroethylene resin (PTFE) or fluorinated ethylene-propylene resin ( FEP), perfluoroalkoxy resin (PFA), ethylene tetrafluoroethylene resin (ETFE), or fluorine rubber material,
Silicone resin materials include methyl silicone rubber.

[0010] Further, the shape when it is placed in the decompression vessel 3 and brought into contact with serum may be a thin flat membrane shape or a hollow tube shape (tube shape) having a required inner diameter and length. It is installed inside the decompression container 3 so as to be in contact with it. When the serum is brought into contact with the permeable membrane 4, the serum may flow on the permeable membrane 4 or may stay on the permeable membrane 4.

In the illustrated embodiment, a permeable membrane 4 formed in a hollow tube shape (tube shape) having a required length is used.
One or more of them are placed inside the decompression container 3, and a liquid feed pump 6 is connected to the inlet side of the permeable membrane 4 formed in a tubular shape, and the storage container 2 is connected to the liquid outlet side, and The serum contained in the container 1 is circulated through the tubular permeable membrane 4 by the liquid sending pump 6 while the pressure inside the vacuum vessel 3 is controlled by the vacuum pump 5 under reduced pressure. The system is designed to remove the gas that had dissolved therein while exiting from the exit side and perform degassing processing. At this time, the liquid sending pump 6 is not limited to the inlet side of the tubular permeable membrane 4, but may be provided on the outlet side.

The serum degassed by contacting the permeable membrane 4 is basically kept online as it is,
It is sealed and stored in a storage container (storage bag) 2 made of an airtight material such as glass material or polyvinyl chloride, and stored at room temperature or a low temperature of about 4 ° C. In addition, the serum may be stored in a frozen state in a sealed state in a storage container (storage bag) 2. By storing frozen, the shelf life can be further extended.

It is also conceivable that the permeable membrane 4 installed in the depressurized container 3 for passing only the gas and preventing the permeation of the liquid also serves as the storage container 2 as it is. That is, the pressure inside the depressurized container 3 is reduced and the serum is brought into contact with the permeable membrane 4 to degas the gas dissolved in the serum. If the inlet side and the outlet side are sealed, the serum in contact with the permeable membrane 4 can be preserved as it is, and the permeable membrane 4 can also be used as the storage container 2.

[0014]

According to the method for storing serum according to the present invention,
Since the gas dissolved in the serum was degassed and the degassed serum was sealed and stored, the concentration of gas such as oxygen gas dissolved in the serum was extremely reduced. Thus, it is possible to suppress the deterioration with time due to oxidation and other denaturation of enzymes, lipoproteins and other proteins contained in serum. Therefore, the serum can be stored for a long time with a simple refrigerator at room temperature or about 4 ° C. without adding a preservative or freezing.

In addition, since the processing for preserving the serum can be performed with relatively simple equipment (degassing equipment) as compared with the conventional freezing processing method, the serum can be provided at a lower cost than before. Become. In addition, since there is no thawing work at the time of use, there is no fear of deterioration due to thawing, and it is possible to calibrate the testing equipment in the clinical test immediately before the test, eliminating work loss in the test. .

According to the method for preserving serum according to the third aspect of the present invention, the permeable membrane is formed in a hollow tube shape or a flat membrane shape, and the permeable membrane is set in a reduced-pressure container, and the pressure in the reduced-pressure container is reduced. By doing so, the dissolved gas is degassed from the serum through the permeable membrane, so that the degassing of the serum can be easily performed.

According to the method for preserving serum according to the fourth aspect of the present invention, the permeable membrane provided in the decompression container is used also as the storage container. It is possible to provide serum at a low cost with a view to reducing the amount of sera.

[Brief description of the drawings]

FIG. 1 is a schematic diagram showing an example of an apparatus for performing a storage method according to the present invention.

[Explanation of symbols]

 1: container 2: storage container 3: decompression container 4: permeable membrane 5: vacuum pump 6: liquid sending pump

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[Procedure amendment]

[Submission date] December 12, 2000 (200.12.
12)

[Procedure amendment 1]

[Document name to be amended] Statement

[Correction target item name] 0002

[Correction method] Change

[Correction contents]

[0002]

2. Description of the Related Art For example, a liquid serum used for calibrating a testing device when performing a clinical test (this is called a control serum) is used to determine whether or not the test is performed normally. An important issue is whether the control serum or the standard serum for determining the test is accurate as a standard calibration solution. However, as a practical matter, not only serum for administration but also liquid serum used for treatment of diseases and injuries, unless properly preserved, is liable to deteriorate in quality due to deterioration such as decay, oxidation and the like. LDH (lactate dehydrogenase) and CK (creatine kinase) and ALP (alkaline e Sufa te peptidase) contained in lipoprotein
Etc., serum protein with more than 100 in serum oxidation, so easily not easily stabilized Kitaichi degeneration, serum long (1-2
Over a year).

Claims (4)

[Claims] 1. A method for preserving serum, wherein a gas dissolved in serum is degassed, and the degassed serum is sealed and stored. 2. Serum is brought into contact with a permeable membrane that allows only gas to pass therethrough and blocks liquid permeation, degassed the dissolved gas from the serum through the permeable membrane, and sealed the degassed serum in a storage container. A method for preserving serum, characterized in that the serum is preserved. 3. The method according to claim 1, wherein the permeable membrane is formed in a hollow tube shape or a flat membrane shape. 3. The method for storing serum according to claim 2, wherein the serum is degassed. 4. The method for preserving serum according to claim 2, wherein the permeable membrane provided in the decompression container is also used as the storage container.