JP2002267660A - Blood test container - Google Patents

Abstract

(57) [Problem] To prevent contact between a drug such as a blood coagulation accelerator or a blood anticoagulant and a serum or plasma separating agent,
By preventing a drug such as a blood coagulation accelerator or a blood anticoagulant from being mixed into a separating agent, blood that can sufficiently exhibit the intended drug performance without lowering the performance of such a drug. Provide an inspection container. SOLUTION: This blood test container is a bottomed tubular body having one end opened and the other end closed, in which a serum or plasma separating agent is stored at the bottom of the tube. Also, a drug, either a blood coagulation accelerator or a blood anticoagulant, is held on the inner wall of the tube on the opening side, and contact preventing means is provided on the inner wall of the tube between the separating agent and the drug. Blood test container.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a blood test container used for, for example, a clinical test, and more particularly, to a blood test container suitably used for a test using serum or plasma.

[0002]

2. Description of the Related Art Conventionally, serum or plasma separating agents have been used to separate serum (or plasma) from blood. In order to efficiently collect serum (or plasma), a blood coagulation promoter (or blood anticoagulant) is used.

[0003] Usually, when separating serum from blood,
For example, as described in Japanese Patent Application Laid-Open No. 9-28695, a blood test container is used in which a serum separating agent is stored at the bottom of a tube and a drug such as a blood coagulation promoter is held at the tube wall. When plasma is separated from blood, a blood test container is used in which a plasma separating agent is contained at the bottom of the tube and a drug such as a blood anticoagulant is held at the tube wall.

In such a blood test container, after a serum or plasma separating agent is contained in the bottom of a tube, a blood coagulation accelerator (or blood anticoagulant) dissolved (or dispersed) in an appropriate solvent is placed on the inner wall of the tube. It is prepared by spraying and then drying.

However, according to such a preparation method,
The solution of the blood coagulation accelerator (or blood anticoagulant) spray-coated on the inner wall of the tube flows down (dripping) along the tube wall and comes into contact with the serum or plasma separating agent contained in the tube bottom. As a result, there has been a problem that an interaction occurs between the two and drug activity is reduced. In addition, as a result of the blood coagulation accelerator (or blood anticoagulant) being incorporated into the serum or plasma separating agent, there is also a problem that the desired drug performance cannot be exhibited.

[0006]

An object of the present invention is to provide a blood test container for separating serum or plasma, comprising a drug such as a blood coagulation promoter or a blood anticoagulant, and a serum or plasma separating agent. By preventing contact with the drug and preventing drugs such as blood coagulation accelerators and blood anticoagulants from being mixed into the separating agent, the intended drug performance can be improved without lowering the performance of such drugs. It is an object of the present invention to provide a blood test container that can fully demonstrate its function.

[0007]

The present invention provides a blood test container comprising a bottomed tube having one end opened and the other end closed, wherein a serum or plasma separating agent is contained in the bottom of the tube. A blood coagulation accelerator or a blood anticoagulant drug is held on the inner wall of the tube on the opening side of the storage portion of the separating agent, and the inner surface of the tube is in contact with the separating agent and the agent. A blood test container provided with a prevention means.

More preferably, the contact preventing means is an annular projection provided so as to be continuous in the circumferential direction of the inner wall of the tube and project in the axial center direction. is there.

The present invention also provides a blood test container comprising a bottomed tube having one end opened and the other end closed,
Either a blood coagulation promoter or a blood anticoagulant is held on the inner wall of the tube, and the inner diameter of the tube is smaller than the inner diameter of the drug holding portion on the tube bottom side than the drug holding portion. A separating agent storage section in which a separating agent is stored is provided, and a groove for preventing liquid dripping is provided in a step formed by a diameter difference between an inner diameter of the medicine holding section and an inner diameter of the separating agent storing section. A blood test container characterized by the following.

[0010]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, a specific embodiment of a blood test container according to the present invention will be described with reference to the drawings.

FIG. 1 is a sectional view showing an embodiment of the blood test container according to the present invention. The blood test container 1 includes a bottomed tube 2. The material forming the bottomed tubular body 2 is not particularly limited. For example, glass or an appropriate synthetic resin is used, and a transparent or translucent synthetic resin such as polyethylene terephthalate is preferably used.

A serum or plasma separating agent (hereinafter, also simply referred to as a separating agent) 3 is accommodated in the bottom of the bottomed tube 2. The separating agent 3 is not particularly limited, but a thixotropic gel-like substance is preferably used. Examples of such a gel-like substance include those obtained by adding and mixing additives such as a thixotropic agent, a specific gravity adjuster, and a viscosity adjuster to a synthetic resin having fluidity at ordinary temperature. The synthetic resin having fluidity at ordinary temperature is not particularly limited, and examples thereof include oligomers of dicyclopentadiene and oligomers of cyclopentadiene.

The thixotropic agents include:
For example, a condensate of sorbitol and an aromatic aldehyde,
And polyoxyethylene polyoxyalkylene block copolymers.

Examples of the specific gravity adjuster include silica and titanium oxide. Examples of the viscosity modifier include phthalic acid esters and epoxidized soybean oil.

A drug 4 of a blood coagulation promoter or a blood anticoagulant is held on the inner wall of the tube on the opening side of the storage portion in which the separation agent 3 is stored. When obtaining serum,
A blood coagulation promoter is used as the drug 4, and a blood anticoagulant is used when plasma is obtained. In order to hold the drug 4 on the inner wall of the tube, for example, after spraying a solution or dispersion in which the drug is dissolved or dispersed on the inner wall of the tube,
It may be dried.

The blood coagulation promoter is not particularly limited, and examples thereof include inorganic substances such as glass, silica, kaolin, celite, bentonite, and diatomaceous earth, and enzymes such as thrombin.

The blood anticoagulant is not particularly limited, and citric acid, heparin, EDTA and the like can be used.

In the present invention, when serum is obtained, not only a blood coagulation promoter but also a blood clot adhesion inhibitor may be held together with the blood coagulation promoter. As such a blood clot adhesion preventing agent, a hydrophilic substance that is hardly soluble or insoluble in water can be used, for example, silicone oil,
Partially saponified polyvinyl alcohol, vinylpyrrolidone
And vinyl acetate copolymer. As the silicone oil, a silicone oil modified as necessary can be used, and for example, an aliphatic modified silicone oil, an aromatic modified silicone oil, an alcohol modified silicone oil, a polyethyl modified silicone oil and the like can be used. .

When silicone oil is used, it is preferable to further add a water-soluble substance in order to prevent the blood coagulation accelerator from being covered with the silicone oil and thereby reducing blood coagulation performance. Examples of such a water-soluble substance include polyvinyl alcohol and polyvinyl pyrrolidone.

In the blood test container according to the first aspect of the present invention, a contact preventing means is provided on the inner wall of the tube between the separating agent and the drug. As a preferred example of this contact prevention means,
An annular projection 5 is provided which is continuous in the circumferential direction of the inner wall of the pipe and protrudes in the axial center direction. As shown in FIG. 1, the annular projection 5 has a convex vertical cross section. The provision of the annular projection 5 can prevent the drug 4 from dripping and coming into contact with the separating agent 3 after spraying the drug 4 on the inner wall of the tube. Further, even when the serum or plasma separating agent stored in the bottom of the tube is stored for a long period of time in a high temperature environment in a lying state, there is no fear that the serum or plasma separating agent flows in the opening direction and comes into contact with the agent 4.

The annular projection 5 may be formed integrally with the bottomed tube 2 or, after forming the annular body separately, fix the annular body at a predetermined position of the bottomed tube 2. May be configured. When the annular projection 5 is formed separately from the bottomed tube 2, it may be made of the same material as the bottomed tube 2, or may be made of a material such as rubber or elastomer. You may.

The position where the annular projection 5 is provided is not particularly limited as long as it functions as a contact preventing means, but it is 1 to 10 mm, more preferably 2 to 5 mm apart from the upper surface of the separating agent 3 on the opening side. It is good to be provided only in a position. The height of the annular projection 5 (height protruding from the inner wall surface of the pipe in the axial center direction) is preferably about 0.5 to 2 mm, and the width of the annular projection 5 (length in the container longitudinal direction).
Is preferably about 0.1 to 1 mm.

The blood test container can be sealed by closing the opening of the blood test container with a stopper (not shown). As the stopper, a well-known rubber stopper, film stopper, plastic stopper, or the like can be used. In the case of a sealed structure, it can be used as a so-called vacuum blood collection tube.

Next, a specific embodiment of the blood test container of the present invention 2 will be described.

FIGS. 2 and 3 are sectional views showing a specific example of the blood test container according to the second embodiment of the present invention. Blood test container 11,
Reference numeral 21 comprises bottomed tubes 12 and 22. Bottomed tube 12,
As the material constituting 22, the same material as that of the first embodiment can be used.

The inner walls of the bottomed tubes 12, 22 are provided with either a blood coagulation promoter or a blood anticoagulant drug 14, 2
4 are held. As these medicines 14 and 24, the same medicines as the medicine 4 in the present invention 1 described above can be used.

The separating agent, which has a smaller diameter than the inner diameter of the medicine holding portion and is provided with the separating agents 13 and 23 on the tube bottom side from the portion where the medicines 14 and 24 are held (drug holding portion). An accommodating section is provided. As the separating agents 13 and 23, those similar to the separating agent 3 in the present invention 1 can be used. Since the inner diameter of the separating agent storage portion is configured to be smaller than the inner diameter of the medicine holding portion, a step is formed at the boundary portion due to the difference in diameter. Grooves 15 and 25 are provided in this step so that even when the chemicals 14 and 24 applied to the inner wall of the tube by spraying or the like are dripped, the chemicals are accommodated so that they do not come into contact with the separating agents 13 and 23. Is formed. The shape of the groove is not particularly limited as long as a small amount of dripped drug solution can be accommodated.
As shown in FIG. 3, the groove 15 may be provided by the upper surface of the step being inclined in the outer peripheral direction, or the cross section may communicate from the upper end of the step to the vicinity of the tube bottom as shown in FIG. The groove 25 may be provided continuously in the circumferential direction.

Next, the present invention will be described in more detail by giving specific examples and comparative examples.

[Example] Contents 10 ml, 20 from bottom
A bottomed tubular body made of polyethylene terephthalate provided with an annular projection having a width of 0.5 mm and a height of 1 mm at the position of mm was obtained by injection molding. 1.3 g of a serum separating agent containing an oligomer of dicyclopentadiene as a main component was placed on the bottom of the tube of this container.
Was accommodated. Next, 30 μl of a drug (blood coagulation accelerator) composed of an aqueous solution containing 1% by weight of silica, 3% by weight of modified silicone oil and 3% by weight of polyvinylpyrrolidone is spray-coated on the inner wall of the tube, and dried in an oven at 50 ° C. A blood test container of the example was obtained (the cross section is the same as that shown in FIG. 1).

Comparative Example A blood test container of a comparative example was prepared in the same manner as in the above example, except that a normal bottomed tube made of polyethylene terephthalate having no annular projection was used. Obtained.

[Evaluation] The following (1) to (10) were used for each of the ten blood test containers obtained in the above Examples and Comparative Examples.
The item (3) was evaluated. (1) Appearance observation The state of application of the drug was observed for each blood test container. As a result, in the blood test container of Example, none of the drugs was dripped below the annular protrusion,
In the blood test container of the comparative example, the drug dripped and was in contact with the separating agent.

(2) Blood Coagulation Time 8 mL of healthy human blood was collected in each blood test container, mixed 5 times by inversion, and the time until blood coagulation was measured. As a result, in the blood test container of the example, an average of 15
Minutes, whereas the blood test container of the comparative example averaged 30 minutes.

(3) Flow of Separating Agent Each blood test container was turned over, and the state of the separating agent after being left at 55 ° C. for 3 days was observed. As a result, in the blood test container of the example, there was no flow of the separating agent toward the opening side from the annular projection, whereas in the blood test container of the comparative example, the separating agent having a maximum of about 20 mm was closer to the opening side. A flow was established and contact between the separating agent and the drug was observed.

[0034]

According to the blood test container of the present invention, the blood test container comes into contact with the inner wall of the tube between the storage portion of the serum or plasma separating agent and the holding portion of either the blood coagulation promoter or the blood anticoagulant. Since the prevention means is provided, the contact between the separating agent and the drug can be reliably prevented, and the mixing of the drug into the separating agent can also be reliably prevented. Therefore, it is possible to provide a blood test container capable of sufficiently exhibiting the desired drug performance without reducing the drug performance of the blood coagulation promoter or the blood anticoagulant.

[Brief description of the drawings]

FIG. 1 is a longitudinal sectional view showing a blood test container according to one embodiment of the present invention.

FIG. 2 is a longitudinal sectional view showing a blood test container according to one embodiment of the present invention 2.

FIG. 3 is a longitudinal sectional view showing a modified example of the blood test container of the second invention.

[Explanation of symbols]

1, 11, 21 ... blood test container 2, 12, 22 ... bottomed tube 3, 13, 23 ... separating agent 4, 14, 24 ... drug 5 ... contact prevention means (annular projection), 15, 25 ... Drip prevention groove

Claims (3)

[Claims] 1. A blood test container comprising a bottomed tube having one end opened and the other end closed, wherein a serum or plasma separating agent is stored at the bottom of the tube, and a housing portion for the separating agent is provided. A blood coagulation promoting agent or a blood anticoagulant drug is held on the inner wall of the tube closer to the opening side, and contact preventing means is provided on the inner wall of the tube between the separating agent and the drug. Characteristic blood test container. 2. The blood test according to claim 1, wherein the contact preventing means is an annular projection provided so as to be continuous in the circumferential direction of the inner wall of the tube and project in the axial center direction. container. 3. A blood test container comprising a bottomed tube having one end opened and the other end closed, wherein a blood coagulation accelerator or a blood anticoagulant is held on the inner wall of the tube. A separating agent storage portion configured to have a diameter smaller than the inner diameter of the drug holding portion and containing a serum or plasma separating agent is provided on the tube bottom side of the drug holding portion, and the inner diameter of the drug holding portion is reduced. A blood test container, characterized in that a groove formed for preventing liquid dripping is provided in a step formed by a diameter difference from an inner diameter of a separating agent container.