JPH05115464A - Blood taking tube under reduced pressure - Google Patents

Abstract

PURPOSE:To provide the subject tube which is less changed in a reduced pressure state with lapse of time before use and has an excellent property to accelerate blood clotting. CONSTITUTION:The blank material of the blind tubular body having a sealing member of the objective tube consists of 99 to 92wt.% polyester essentially consisting of polyethylene terephthalate and 1 to 8wt.% xylene group-contg. polyamide and, further, contains 1 to 100ppm transition metal. A silicon material and a blood clotting accelerator exist in a dispersed state in the inside wall of this tube.

Description

Detailed Description of the Invention

[0001]

FIELD OF THE INVENTION The present invention relates to a reduced pressure blood collection tube. More specifically, the present invention relates to a reduced pressure blood collection tube which has little change in decompressed state before use with time and is excellent in blood coagulation accelerating property.

[0002]

2. Description of the Related Art Vacuum blood collection tubes are used for biochemical and serological tests,
It is used for hematology test, blood glucose measurement, blood coagulation test, blood sedimentation test, bacteriology test, etc., and consists of a bottomed tube having an opening with a rubber stopper. It is necessary that the inside of this bottomed tube is kept in a depressurized state at the time of use, and the degree of depressurization is kept in a depressurized state corresponding to it so that the blood volume (1 to 20 ml) can be collected as much as necessary. ing.

Conventionally, the material for the bottomed tube has been glass, but since glass is easily broken, it is being replaced by synthetic resin recently. The synthetic resin for the vacuum blood collection tube is selected from polyester, polyethylene, polypropylene and the like.

If the synthetic resin tube is used as it is for a vacuum blood collection tube, coagulation of blood is slow, and it takes a long time to separate serum and blood cells by a centrifugation method. If the time from blood collection to blood coagulation is long, it is not convenient for an emergency test, and fibrin is easily produced in serum, so that a good blood sample cannot be collected. For this reason, it is necessary to add a blood coagulation promoter when separating blood serum and blood cells by centrifugation using a synthetic resin vacuum blood collection tube.

On the other hand, since blood tends to adhere to the tube wall as blood clots only with the blood coagulation promoter, it is necessary to use a substance that does not adhere blood clots to the tube wall, such as hydrophilic silicone.

[0006]

The synthetic resin vacuum blood collection tube is inferior to the glass vacuum blood collection tube in gas barrier property. For this reason, studies have been made on packaging materials such as vacuum packaging of vacuum blood collection tubes during storage, or inclusion of a specific gas inside the packaging.

Further, since both the blood coagulation promoter and the substance that does not allow blood clots to adhere to the tube wall are substances having contradictory effects on agglutination, it is difficult to control them so that they exist well.

The present invention has excellent gas barrier properties,
And it is an object to provide a synthetic resin reduced-pressure blood collection tube excellent in blood coagulation accelerating property, and according to the present invention, the reduced pressure state inside the reduced pressure blood collection tube before blood collection is maintained for a long time, and blood coagulation accelerating property Both the blood coagulation promoter and the substance that does not allow blood clots to adhere to the tube wall can be successfully present on the tube wall.

[0009]

The present invention comprises a sealing member and a bottomed tubular body, and the material of the bottomed tubular body is polyethylene terephthalate or a polyester containing polyethylene terephthalate as a main component in an amount of 99 to 92% by weight. A vacuum blood collection tube having a composition of 1 to 8% by weight of a xylylene group-containing polyamide and further containing 1 to 100 ppm of a transition metal, wherein a silicon-based substance and a blood coagulation promoter are dispersed in the inner wall of the tube. The gist is a reduced-pressure blood collection tube characterized by:

In the present invention, the sealing member means a member used for a reduced pressure blood collection tube. For example, the term refers to a detachable elastic rubber plug or a sealing member including a gas barrier member and a sealing member.

In the present invention, polyethylene terephthalate is a general-purpose polyester obtained by reacting ethylene glycol with terephthalic acid or its ester (especially dimethyl terephthalate). But,
It also includes ethylene terephthalate having a repeating unit content of 60% or more. Examples of the copolymerization component include isophthalic acid / naphthalenedicarboxylic acid / p-oxybenzoic acid derivative; butanediol.

If the molecular weight of the polyester polymer is an intrinsic viscosity [η] of 0.6 to 0.9, a satisfactory bottomed tubular body for use in the present invention can be obtained without problems in molding.

In the present invention, the xylylene group-containing polyamide contains, for example, poly-m-xylylene adipamide, which is formed by the condensation reaction of m-xylylenediamine and adipic acid, in an amount of 70% or more of the constitutional unit, and as a copolymerization component. , P-xylylene adipamide, hexamethylene diamine; aminocaproic acid, sebacic acid and the like.

In the present invention, the transition metal is used in the form of a salt,
Examples include cobalt acetate, cobalt naphthenate, cobalt stearate, nickel acetyl acetate, nickel chloride, and rhodium chloride.

In the present invention, the material of the bottomed tubular body is a mixture of polyethylene terephthalate, xylylene group-containing polyamide, and a salt of a transition metal. This mixing may be carried out by mixing the raw materials at the time of charging in the molding step or by that time. Good.

When a xylylene group-containing polyamide is mixed and molded, the product may have a yellowish tint. A good balance of composition can eliminate this yellowing. This yellowish tint can be eliminated by preparing a master chip containing about 1% of a blue or purple pigment and adding the master chip by weight to the same extent as the xylylene group-containing polyamide.

The present invention is a reduced pressure blood collection tube comprising a bottomed tube and a sealing member, wherein the material of the bottomed tube contains polyethylene terephthalate or a polyester containing polyethylene terephthalate as a main component and a xylylene group. The first characteristic is that it is made of polyamide and further contains a transition metal, and the second characteristic is that the silicon-based substance and the blood coagulation promoter are present in a dispersed state on the inner wall of the tube.

Hydrophilic silicone is used as a substance to which blood is unlikely to adhere. In the present invention, the hydrophilic silicon and the blood coagulation promoter are present on the inner wall of the tube in a dispersed state.

At this time, a hydrophilic silicon layer can be formed on the inner wall surface of the tube by selecting the hydrophilicity of the hydrophilic silicon.

Generally, a blood coagulation promoter is insoluble in a solvent and therefore exists in a suspended state during coating. However, it is preferable to add a water-soluble polymer to this so that the blood coagulation promoter can exist in a stable state.

Further, for example, silicon may be added in order to stabilize the blood coagulation promoter mixed liquid during coating. Silicone in this case is hydrophilic, but silicone oil which is almost insoluble in water is used.

As the water-soluble polymer to be added to the blood coagulation promoter solution in the present invention, polyvinyl alcohol, polyvinylpyrrolidone, polyethylene glycol, polyacrylamide, polyacrylic acid, methyl cellulose, carboxymethyl cellulose, hydroxyethyl cellulose, starch, casein and the like are used. ..

In the present invention, the hydrophilic silicon dispersed in the tube wall is highly hydrophilic and water-soluble.
In addition to the polyether polydimethylsiloxane copolymer, fluorine-modified silicone oil, alcohol-modified silicone oil, silicone modified with a hydrophilic group such as carboxyl group, amino group and methylol group is used.

In the present invention, as the blood coagulation promoter, silica sand, crystalline silica fine powder, diatomaceous earth, glass fine powder, kaolin, bentonite, celite, calcium carbonate fine powder, titanium oxide fine powder and the like are used.

[0025]

In the present invention, the general-purpose polyester is mixed with the xylylene group-containing polyamide to contain the transition metal salt in order to obtain a bottomed tubular body having an excellent gas barrier property and to absorb oxygen with the xylylene group-containing polyamide. It is considered that the transition metal salt serves as a catalyst for promoting this behavior.

The synthetic resin vacuum blood collection tube of the present invention, which is excellent in gas barrier properties, absorbs oxygen in this manner, and the reduced pressure inside the vacuum blood collection tube before use is maintained for a long period of time from inventory to blood collection. Will be.

In the present invention, the mixture should have a mixing ratio of 99 to 92% by weight of polyethylene terephthalate and 1 to 8% by weight of xylylene group-containing polyamide. When the amount of the xylylene group-containing polyamide is more than this limit value, the transparency becomes poor and the raw material cost of the tubular body becomes expensive. On the other hand, if it is less than this limit value, the oxygen absorbability of the tubular body is deteriorated.

In the present invention, the transition metal salt needs to be contained in an amount of 1 to 100 ppm with respect to the material polymer of the bottomed tubular body. If the amount of the transition metal salt is more than this limit value, the tube is colored, the transparency is deteriorated, and the raw material cost is increased.
On the other hand, when the amount is less than the limit value, the function of the catalytic action for promoting the oxygen absorption property is deteriorated.

The polymer for bottomed tubing in the present invention may of course contain an additive that does not adversely affect the blood collection tube. Examples thereof include antioxidants, ultraviolet blocking agents, extrusion aids and other additives for improving physical properties.

In the present invention, the inner wall of the tube is covered with hydrophilic silicon, so that blood is unlikely to adhere to the tube wall. Since the blood coagulation promoter exists in a state of being dispersed in the tube wall, the blood clot does not adhere to the tube wall. Although the blood coagulation promoter is in a dispersed state, most of it is present on the blood side, so that it can be brought into more contact with blood and coagulation can be completed quickly.

[0031]

EXAMPLES The present invention will be specifically described below with reference to examples. Using the materials having the compositions shown in Table 1, a bottomed tubular body having a wall thickness of 1.3 mm, an inner diameter of 12.8 mm, and a volume of 5 ml with one end closed and the other end open was prepared, and the inside of the tube was -450 mm.
A blood collection tube was obtained which was hermetically sealed with a rubber stopper made of butyl rubber under a reduced pressure of Hg.

The vacuum blood collection tubes thus obtained were provided with 10 tubes for each of Examples and Comparative Examples and stored at 50 ° C., after which the degree of vacuum retention was measured every two weeks. The results are shown in Table 1.

Then, on the inner wall of the tube having the composition of Example 2, 0.5 of silicon oil and fine powder of celite (particle size 5 to 5) were used.
20 μm) 1.0, polyvinylpyrrolidone 1.0% by weight, isopropyl alcohol liquid is sprayed on the inner wall of the tube,
It was dried at ° C.

As the silicone oil, polyether-modified silicone (made by Toshiba Silicon) having different hydrophilicity was used, and TSF4440 (freezing point 5 ° C., 1% aqueous solution cloud point 67) was used.
C.) and TSF4445 (freezing point −5 ° C., 1% aqueous solution without cloud point), TSF4452 (freezing point −20 ° C. or lower, 1%
Three types of aqueous solution cloud point 31 ° C.) were used.

[0035]

[Table 1]

This tube was vacuum-stopped at -450 mmHg, and 10 tubes each were collected by vacuum sampling blood from the rabbit heart immediately after blood sampling, mixed by inversion, and then inclined every 30 seconds until coagulation. Was measured. After that, it was left for 45 minutes, centrifuged at 1300 G for 10 minutes, and the state of blood was observed.

The results are shown in Table 2. Coagulation time is 8 ~
At 12 minutes, there was little blood clot adhesion to the tube wall, and no tube caused hemolysis or fibrin formation.

[0038]

[Table 2]

[0039]

EFFECTS OF THE INVENTION According to the present invention, since (1) the material of the bottomed tubular body is polyethylene terephthalate or a polyester containing polyethylene terephthalate as a main component and a xylylene group-containing polyamide, a transition metal is further contained.
It is possible to provide a reduced-pressure blood collection tube with little change in the reduced-pressure state before use over time, and (2) because the silicon-based substance and the blood coagulation promoter are dispersed in the inner wall of the tube, it has excellent blood coagulation accelerating properties. A reduced pressure blood collection tube can be provided.

Claims (1)

[Claims] 1. A sealing member and a bottomed tubular body, wherein the bottomed tubular body is made of polyethylene terephthalate or polyester 9 containing polyethylene terephthalate as a main component.
9 to 92 wt% and xylylene group-containing polyamide 1 to 8
It has a composition of wt% and further contains 1 to 100 ppm of transition metal.
A reduced-pressure blood collection tube containing, wherein a silicon-based substance and a blood coagulation promoter are present in a dispersed state on the inner wall of the tube.