JP2000000228A - Blood specimen collection tube - Google Patents
Blood specimen collection tubeInfo
- Publication number
- JP2000000228A JP2000000228A JP10165745A JP16574598A JP2000000228A JP 2000000228 A JP2000000228 A JP 2000000228A JP 10165745 A JP10165745 A JP 10165745A JP 16574598 A JP16574598 A JP 16574598A JP 2000000228 A JP2000000228 A JP 2000000228A
- Authority
- JP
- Japan
- Prior art keywords
- blood
- collection tube
- blood collection
- blood coagulation
- coagulation
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Abstract
Description
【０００１】[0001]
【発明の属する技術分野】本発明は、血液検査に用いる
血液試料を採取するための採血管に関する。TECHNICAL FIELD The present invention relates to a blood collection tube for collecting a blood sample used for a blood test.
【０００２】[0002]
【従来の技術】合成樹脂製採血管ではガラス製採血管に
比べ血液凝固時間がかかるため、ガラス管と同等の血液
凝固時間とするものとして特公昭５９−６６５５や、特
公昭５８−２７９３３に開示された採血管が知られてい
る。しかし、前者は血液凝固を促進する物質を島状に塗
布しなければならず、その製造方法が複雑である。後者
は血液凝固促進媒体を担持するための担体を採血管内に
収容させる必要がある。また、シリカ粒子と比べ血液凝
固促進能が高い血液凝固促進剤であるトロンビン、蛇毒
抽出物質等は血液凝固促進能が非常に不安定なため単純
に封入する事はできず、封入形態、状態に工夫が必要と
なる。そのため血液凝固促進剤を管体内面に塗布した
り、更には凍結乾燥を行う等の工程が必要となるが、生
産方法が複雑で生産効率が悪く、大量生産することは困
難であった。2. Description of the Related Art A blood collection tube made of synthetic resin requires a longer time to coagulate than a blood collection tube made of glass, and is disclosed in Japanese Patent Publication Nos. 59-6655 and 58-27933 as having a blood coagulation time equivalent to that of a glass tube. Obtained blood collection tubes are known. However, in the former, a substance that promotes blood coagulation must be applied in an island shape, and the production method is complicated. In the latter, a carrier for supporting the blood coagulation accelerating medium needs to be accommodated in the blood collection tube. In addition, thrombin and snake venom extract substances, which are blood coagulation promoters having higher blood coagulation promoting ability than silica particles, cannot be simply encapsulated because the blood coagulation accelerating ability is very unstable. Ingenuity is required. Therefore, a process such as applying a blood coagulation accelerator to the inner surface of the tube and further performing freeze-drying is required, but the production method is complicated, production efficiency is poor, and mass production has been difficult.
【０００３】[0003]
【発明が解決しようとする課題】本発明の目的は、ガラ
ス製採血管より短時間で血液を凝固させる事が可能であ
って、かつ製造方法の容易な合成樹脂製採血管を提供す
ることである。SUMMARY OF THE INVENTION An object of the present invention is to provide a synthetic resin blood collection tube that can coagulate blood in a shorter time than a glass blood collection tube and that can be easily manufactured. is there.
【０００４】[0004]
【課題を解決するための手段】本発明は次の手段によっ
て達成される。The present invention is achieved by the following means.
【０００５】（１）血液凝固促進剤を含む顆粒が封入さ
れたことを特徴とする採血管。(1) A blood collection tube in which granules containing a blood coagulation promoter are enclosed.
【０００６】（２）前記血液凝固促進剤が無機物または
血液凝固活性を有する物質のいずれかまたはその組み合
わせである（１）に記載の採血管。(2) The blood collection tube according to (1), wherein the blood coagulation promoter is any one of an inorganic substance and a substance having a blood coagulation activity or a combination thereof.
【０００７】（３）前記無機物がシリカ粒子、ガラス粉
末、または珪藻土やカオリン等のＳｉＯ2を含む混合物
である（２）に記載の採血管。(3) The blood collection tube according to (2), wherein the inorganic substance is silica particles, glass powder, or a mixture containing SiO 2 such as diatomaceous earth and kaolin.
【０００８】（４）前記血液凝固活性を有する物質が、
トロンビン、トロンビン様酵素、またはそれらを含む蛇
毒抽出物質である（２）に記載の採血管。(4) The substance having blood coagulation activity is
The blood collection tube according to (2), which is thrombin, a thrombin-like enzyme, or a snake venom extract containing the same.
【０００９】（５）前記顆粒が血液凝固促進剤とバイン
ダーとからなる（１）記載の採血管。(5) The blood collection tube according to (1), wherein the granules comprise a blood coagulation promoter and a binder.
【００１０】（６）前記バインダーが、ポリビニルピロ
リドン、ポリビニルアルコール等の水溶性物質、カルボ
キシメチルセルロース、ヒドロキシエチルセルロース、
ヒドロキシプロピルセルロース、エチルヒドロキシエチ
ルセルロース、エチルセルロース、メチルセルロース、
カルボキシメチルエチルセルロース、ヒドロキシプロピ
ルメチルセルロース等の水溶性セルロース誘導体、２−
ヒドロキシエチルアクリレート、２−ヒドロキシプロピ
ルアクリレート等の水溶性アクリル酸誘導体、ゼラチ
ン、でんぷん等の水溶性多種タンパク質の混合物質から
なる群のいずれか１種以上の物質を含む（５）に記載の
採血管。(6) The binder is a water-soluble substance such as polyvinylpyrrolidone or polyvinyl alcohol, carboxymethylcellulose, hydroxyethylcellulose,
Hydroxypropyl cellulose, ethyl hydroxyethyl cellulose, ethyl cellulose, methyl cellulose,
Water-soluble cellulose derivatives such as carboxymethylethylcellulose and hydroxypropylmethylcellulose;
(5) The blood collection tube according to (5), which contains at least one substance selected from the group consisting of a mixture of water-soluble acrylic acid derivatives such as hydroxyethyl acrylate and 2-hydroxypropyl acrylate, and water-soluble multi-proteins such as gelatin and starch. .
【００１１】（７）採血管内に血清分離剤が封入され、
前記血液凝固促進剤が血清分離剤に接着しないように、
または捕捉されないように封入された（１）に記載の採
血管。(7) A serum separating agent is enclosed in the blood collection tube,
To prevent the blood coagulation promoter from adhering to the serum separating agent,
Alternatively, the blood collection tube according to (1), which is sealed so as not to be captured.
【００１２】（８）採血管内が空間遮断部材により２つ
の空間に分割され、一方の空間に血清分離剤、他方の空
間に顆粒の血液凝固促進剤が封入された（７）に記載の
採血管。(8) The blood collection tube according to (7), wherein the inside of the blood collection tube is divided into two spaces by a space blocking member, and one of the spaces is filled with a serum separating agent and the other is filled with a granular blood coagulation accelerator. .
【００１３】（９）採血管内で血清分離剤の露出してい
る部分の上にシリコーンの層が存在している（７）に記
載の採血管。(9) The blood collection tube according to (7), wherein a silicone layer is present on the exposed portion of the serum separating agent in the blood collection tube.
【００１４】（１０）顆粒の血液凝固促進剤に水溶性シ
リコーンが表面コートされた（７）に記載の採血管。(10) The blood collection tube according to (7), wherein the water-soluble silicone is surface-coated on the granular blood coagulation accelerator.
【００１５】（１１）顆粒の血液凝固促進剤に水溶性シ
リコーンが混合された（７）に記載の採血管。(11) The blood collection tube according to (7), wherein the water-soluble silicone is mixed with the blood coagulation accelerator in granules.
【００１６】（１２）血液安定剤として抗プラスミン剤
を含む血液凝固促進剤が封入された（７）に記載の採血
管。(12) The blood collection tube according to (7), wherein a blood coagulation promoter containing an antiplasmin agent is enclosed as a blood stabilizer.
【００１７】[0017]
【発明の実施の形態】本発明はシリカ粒子等の無機物
や、トロンビンや蛇毒抽出物質等の生物由来の血液凝固
活性を有する物質等の血液凝固促進剤を顆粒として採血
管に封入するため、ガラス製採血管に比べて血液凝固時
間を短縮することを目的とする。BEST MODE FOR CARRYING OUT THE INVENTION The present invention relates to a method for enclosing inorganic substances such as silica particles and blood coagulation accelerators such as thrombin and substances having biological coagulation activity such as a substance extracted from snake venom into blood collection tubes as granules. It is intended to shorten the blood coagulation time as compared with a blood collection tube.
【００１８】凍結乾燥された血液凝固促進剤のようにバ
インダーが存在しない場合、トロンビンなどの生物由来
の血液凝固活性を有する物質は特に血液凝固促進作用が
非常に急速なため、トロンビンが血液全体に拡散する以
前に部分凝固してしまい、トロンビンの分散ムラを生
じ、ひいては血液全体の凝固ムラを生じやすい。In the absence of a binder, such as a lyophilized blood coagulation promoter, substances having biological blood coagulation activity, such as thrombin, have a very rapid blood coagulation promoting action, so that thrombin is distributed throughout the blood. Partial coagulation occurs before diffusion, resulting in uneven dispersion of thrombin and, thus, uneven coagulation of the whole blood.
【００１９】しかし本発明では、採血後血液は顆粒の血
液凝固促進剤に接触し、バインダーが徐々に溶解するの
に伴ってトロンビンも徐々に溶解するため、トロンビン
が血液中に均一に分散し安定した凝固が可能となる。However, in the present invention, after blood collection, the blood comes into contact with the blood coagulation promoter in granules, and the thrombin gradually dissolves as the binder gradually dissolves. Solidification is possible.
【００２０】また、バインダーを用いて血液凝固促進剤
を顆粒状とし、計量等の操作が容易な形状にすること
で、従来のような血液凝固促進剤の管壁への塗布や凍結
乾燥等の工程が不必要となり、管体への封入等の生産効
率が向上する。The blood coagulation accelerator is formed into granules by using a binder, and is formed into a shape which can be easily measured and operated. This eliminates the need for a process, and improves production efficiency such as encapsulation in a tube.
【００２１】本発明の採血管に封入される顆粒の血液凝
固促進剤としては、シリカ粒子、ガラス粉末、または珪
藻土やカオリン等のＳｉＯ2を含む混合物等の無機物、
あるいはトロンビン、トロンビン様酵素がある。また、
透析患者等のヘパリン加血にはトロンビン様酵素を含む
蛇毒抽出物質等の血液凝固活性を有する物質が望まし
い。さらに、これらの物質を適宜組み合わせたものでも
よい。Examples of the blood coagulation promoter of the granules enclosed in the blood collection tube of the present invention include inorganic substances such as silica particles, glass powder, and a mixture containing SiO 2 such as diatomaceous earth and kaolin.
Alternatively, there are thrombin and thrombin-like enzymes. Also,
A substance having a blood clotting activity such as a snake venom extract containing a thrombin-like enzyme is desirable for heparinized blood of a dialysis patient or the like. Further, these substances may be appropriately combined.
【００２２】本発明の顆粒である血液凝固促進剤を得る
方法としては、一旦、バインダーと血液凝固活性を有す
る物質とを水に溶かし、これを凍結乾燥した後に砕き、
更にふるいを通し粒径を揃えて顆粒の血液凝固促進剤を
得る方法がある。粒径は約３２ｍｅｓｈのふるいを通り
約６０ｍｅｓｈのふるいを通らない範囲のものが、計量
および採血管への分注に適している。また、この範囲で
あれば血液に触れたときの分散速度が適当であり、急速
な溶解による凝固ムラを防ぐことができる。As a method for obtaining the blood coagulation accelerator which is the granule of the present invention, a binder and a substance having a blood coagulation activity are once dissolved in water, lyophilized, and then crushed.
Further, there is a method of obtaining a blood coagulation accelerator in the form of granules by passing the particles through a sieve to make the particle diameter uniform. Particle sizes in the range of about 32 mesh sieve and not about 60 mesh sieve are suitable for metering and dispensing into blood collection tubes. In addition, within this range, the dispersion speed upon contact with blood is appropriate, and coagulation unevenness due to rapid dissolution can be prevented.
【００２３】本発明のバインダーとしては、例えば、ポ
リビニルピロリドン、ポリビニルアルコール等の水溶性
物質、カルボキシメチルセルロース、ヒドロキシエチル
セルロース、ヒドロキシプロピルセルロース、エチルヒ
ドロキシエチルセルロース、エチルセルロース、メチル
セルロース、カルボキシメチルエチルセルロース、ヒド
ロキシプロピルメチルセルロース等の水溶性セルロース
誘導体、２−ヒドロキシエチルアクリレート、２−ヒド
ロキシプロピルアクリレート等の水溶性アクリル酸誘導
体、ゼラチン、でんぷん等の水溶性多種タンパク質の混
合物質などが挙げられる。Examples of the binder of the present invention include water-soluble substances such as polyvinylpyrrolidone and polyvinyl alcohol, carboxymethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, ethylhydroxyethylcellulose, ethylcellulose, methylcellulose, carboxymethylethylcellulose and hydroxypropylmethylcellulose. Examples include water-soluble cellulose derivatives, water-soluble acrylic acid derivatives such as 2-hydroxyethyl acrylate and 2-hydroxypropyl acrylate, and mixed substances of water-soluble multi-proteins such as gelatin and starch.
【００２４】本発明において、血液安定剤を顆粒に含有
させてもよい。血液安定剤である抗プラスミン剤として
は、アプロチニン等がある。In the present invention, a blood stabilizer may be contained in the granules. Examples of antiplasmin agents which are blood stabilizers include aprotinin.
【００２５】本発明において、採血管内に血清分離剤が
収納されていてもよい。血清分離剤としてはオレフィン
系樹脂に無機充填剤を配合したもの、ポリエステル系樹
脂に無機充填剤を配合したもの、ポリブテン系樹脂に無
機充填剤を配合したもの、アクリル系樹脂に無機充填剤
を配合したもの等が挙げられる。In the present invention, a serum separating agent may be contained in the blood collection tube. Serum-separating agent containing olefin resin mixed with inorganic filler, polyester resin mixed with inorganic filler, polybutene resin mixed with inorganic filler, acrylic resin mixed with inorganic filler And the like.
【００２６】血清分離剤が封入されている採血管におい
ては、血液凝固促進剤は血清分離剤と接触していないの
が好ましい。血液凝固促進剤が血清分離剤に接触し血清
分離剤に接着、または血清分離剤中に捕捉された場合は
血液凝固促進能の低下を生じる。これを防止するには、
成形物やフィルムを空間遮断物として用い、血清分離剤
表面から離れた位置に配置してもよいし、血清分離剤の
表面を密着して覆うように配置してもよい。いずれの方
法においても、成形物やフィルムは採血管の空間を２つ
に分ける壁の様に存在させ、一方の空間には血清分離
剤、他方の空間には血液凝固促進剤を封入する。血清分
離剤と顆粒の血液凝固促進剤を物理的に離すことによ
り、血清分離剤と顆粒が直接接触せず、血清分離剤の影
響を受けないようにできる。In the blood collection tube containing the serum separating agent, the blood coagulation promoter is preferably not in contact with the serum separating agent. When the blood coagulation accelerator comes into contact with and adheres to the serum separating agent, or is trapped in the serum separating agent, the blood coagulation promoting ability is reduced. To prevent this,
The molded article or film may be used as a space barrier, and may be arranged at a position away from the surface of the serum separating agent, or may be arranged so as to closely cover the surface of the serum separating agent. In either method, the molded product or film is present as a wall dividing the space of the blood collection tube into two, and one of the spaces is filled with a serum separating agent and the other is filled with a blood coagulation promoter. By physically separating the serum separating agent and the blood coagulation promoter of the granules, the serum separating agent and the granules do not come into direct contact with each other, so that the serum separating agent is not affected by the serum separating agent.
【００２７】このような採血管の製造方法としては、例
えば、採血管内に血清分離剤を分注後、射出成形、ブロ
ー成形、プレス成形等の各種成形方法または切削によっ
て得られた成形品、フィルム、不織布またはそれらを重
ねたものを挿入して壁の代わりとし、更にその上に血液
凝固促進剤を分注する方法がある。As a method for producing such a blood collection tube, for example, after dispensing a serum separating agent into the blood collection tube, various molding methods such as injection molding, blow molding, press molding, or molded products or films obtained by cutting are used. There is a method of inserting a non-woven fabric or a laminate thereof as a substitute for a wall, and further dispensing a blood coagulation promoting agent thereon.
【００２８】成形品としては、プラスチック製のもので
あれば何でもよく、ポリプロピレン・ポリエチレン等の
オレフィン樹脂、ポリアミド、ポリスチレン、ポリエチ
レンテレフタレート等のポリエステル樹脂、アクリル樹
脂、塩化ビニル、ポリカーボネート、アクリロニトリル
ブタジエンスチレン樹脂等の各種熱可塑性樹脂、および
フィラー入りポリプロピレン、フィラー入りポリカーボ
ネート等の各種充填剤入り熱可塑性樹脂、各種熱可塑性
エラストマー、熱硬化性樹脂等が用いられ、天然ゴム・
合成ゴム等のゴム材質や、金属、ガラス等でも可能であ
り、血清より比重の大きいものが好ましい。The molded article may be any plastic article, such as olefin resin such as polypropylene and polyethylene, polyester resin such as polyamide, polystyrene and polyethylene terephthalate, acrylic resin, vinyl chloride, polycarbonate, acrylonitrile butadiene styrene resin and the like. Various thermoplastic resins, and various types of filler-containing thermoplastic resins such as polypropylene with fillers and polycarbonate with fillers, various thermoplastic elastomers, thermosetting resins, and the like are used.
A rubber material such as synthetic rubber, metal, glass, or the like is also possible, and a material having a specific gravity higher than that of serum is preferable.
【００２９】フィルムとしては、プラスチック製フィル
ムであれば何でもよく、例えば、延伸ＰＥＴフィルム、
ナイロンフィルム、フィラー充填ＰＰフィルム、フィラ
ー充填ＰＥフィルム、プラスチックラミネートアルミ箔
フィルム等が用いられ、さらに血液凝固促進剤が付着し
やすいように、表面処理、例えばプラズマ処理やエンボ
ス加工を施したものも用いられる。不織布の材料として
は、ポリエステル、ナイロン、レーヨンおよびそれらを
組み合わせたものが用いられる。いずれも血清より比重
の大きいものが好ましい。The film may be any plastic film, for example, a stretched PET film,
Nylon film, filler-filled PP film, filler-filled PE film, plastic-laminated aluminum foil film, etc. are used, and those that have been subjected to surface treatment, for example, plasma treatment or embossing, so that the blood coagulation accelerator easily adheres are also used. Can be As the material of the nonwoven fabric, polyester, nylon, rayon and a combination thereof are used. In any case, those having a specific gravity higher than that of serum are preferable.
【００３０】さらに、血液凝固促進剤が血清分離剤に接
着しないように、または血清分離剤中に捕捉されないよ
うにするその他の方法としては、採血管内の血清分離剤
が露出している部分の表面にシリコーンを噴霧しコート
する方法。または、採血管内にシリコーン溶液を満たし
た後除去し、風乾、減圧乾燥等の方法により乾燥すると
いう方法（ディッピング方式）。水溶性シリコーンを顆
粒の血液凝固促進剤の表面に噴霧しコートする方法。造
粒時に血液凝固促進剤やポリビニルピロリドン等と一緒
に水溶性シリコーンを混合し造粒する方法などがある。Further, as another method for preventing the blood coagulation accelerator from adhering to the serum separating agent or being trapped in the serum separating agent, the surface of the blood collecting tube where the serum separating agent is exposed may be used. To spray and coat silicone. Alternatively, the blood collection tube is filled with a silicone solution and then removed, followed by drying by a method such as air drying or reduced pressure drying (dipping method). A method of spraying and coating a water-soluble silicone on the surface of a blood coagulation promoter in granules. There is a method in which a water-soluble silicone is mixed with a blood coagulation accelerator, polyvinylpyrrolidone, or the like during granulation to granulate.
【００３１】これらの方法により、長期保存後でも血液
凝固促進剤が血清分離剤の影響を受けて血液への溶解が
血清分離剤により阻害されることがなく、凝固時間に誤
差が生じる等の問題がなくなる。By these methods, even after long-term storage, the blood coagulation accelerator is not affected by the serum separating agent, so that the dissolution in blood is not inhibited by the serum separating agent, resulting in an error in coagulation time. Disappears.
【００３２】本発明の採血管の材質としては、ポリエチ
レンテレフタレート、共重合ポリエチレンテレフタレー
ト等のポリエステル、ポリアクリロニトリル、ポリメチ
ルメタアクリレート、ポリメタアクリル酸等のアクリル
樹脂、ポリプロピレン、ポリエチレン等のポリオレフィ
ン、ポリ塩化ビニル、ナイロン等のポリアミド、ポリス
チレンなどの熱可塑性樹脂のほか、ガラス等の無機材質
が用いられ、ガスバリアー性の高いものがより好まし
い。Examples of the material of the blood collection tube of the present invention include polyesters such as polyethylene terephthalate and copolymerized polyethylene terephthalate, acrylic resins such as polyacrylonitrile, polymethyl methacrylate, and polymethacrylic acid; polyolefins such as polypropylene and polyethylene; In addition to thermoplastic resins such as polyamides such as vinyl and nylon, and polystyrenes, inorganic materials such as glass are used, and those having high gas barrier properties are more preferable.
【００３３】また、採血管の内面には血餅剥離性物質を
塗布することが好ましい。血餅剥離性物質としては、ポ
リエーテル変性シリコーンオイル等の水溶性シリコー
ン、ジメチルポリシロキサン等の変性シリコーンオイ
ル、ポリプロピレングリコール等のグリコール類、パラ
フィン、ワックス類、フタル酸ジオクチル等の可塑剤、
各種セルロース誘導体等が好ましい。It is preferable to apply a blood clot detachable substance to the inner surface of the blood collection tube. Examples of clot-releasable substances include water-soluble silicones such as polyether-modified silicone oils, modified silicone oils such as dimethylpolysiloxane, glycols such as polypropylene glycol, paraffins, waxes, plasticizers such as dioctyl phthalate,
Various cellulose derivatives are preferred.
【００３４】採血管内に血餅剥離性物質を塗布する方法
としては、採血管内に噴霧または採血管内に血餅剥離性
物質を満たした後除去し、風乾、熱乾燥、減圧乾燥等の
方法により乾燥するという方法がある。As a method of applying the clot-releasing substance to the blood collection tube, the blood collection tube is sprayed or the blood collection tube is filled with the clot-removing material and then removed, and then dried by a method such as air drying, heat drying, and vacuum drying. There is a way to do it.
【００３５】[0035]
【実施例】（実施例１）血液凝固促進剤として、シリカ
粒子を４．５ｍｇ、バインダーとしてポリビニルピロリ
ドン（ＰＶＰ）を１００ｍｇ、これらを混合して顆粒の
血液凝固促進剤を造粒した。得られた顆粒の粒径は３２
ｍｅｓｈ〜６０ｍｅｓｈのものであった。 この顆粒を
１本当たり１０ｍｇ封入したポリエステル製減圧採血管
を作製した（図１参照）。EXAMPLES Example 1 4.5 mg of silica particles as a blood coagulation promoter and 100 mg of polyvinylpyrrolidone (PVP) as a binder were mixed to granulate a blood coagulation promoter. The particle size of the obtained granules is 32
Mesh to 60 mesh. A reduced-pressure blood collection tube made of polyester was prepared by enclosing 10 mg of each of these granules (see FIG. 1).
【００３６】（実施例２）血液凝固促進剤として、トロ
ンビン（牛血漿由来：持田製薬株式会社製）を２００Ｉ
Ｕ、バインダーとしてＰＶＰを１００ｍｇ、アプロチニ
ンを２５００単位、これらを混合して顆粒の血液凝固促
進剤を造粒した。得られた顆粒の粒径は３２ｍｅｓｈ〜
６０ｍｅｓｈのものであった。Example 2 As a blood coagulation promoter, thrombin (derived from bovine plasma: manufactured by Mochida Pharmaceutical Co., Ltd.) was used for 200I.
U, 100 mg of PVP as a binder and 2500 units of aprotinin were mixed and granulated to form a granulated blood coagulation promoter. The particle size of the obtained granules is 32 mesh ~
It was of 60 mesh.
【００３７】この顆粒を１本当たり１０ｍｇ封入したポ
リエステル製減圧採血管を作製した（図１参照）。A polyester vacuum blood collection tube in which 10 mg of each of the granules was sealed was prepared (see FIG. 1).
【００３８】（実施例３）血液凝固促進剤として、トロ
ンビン２００ＩＵ、バインダーとしてＰＶＰを１００ｍ
ｇ、蛇毒抽出物（リセラーゼ：ＰＥＮＴＡＰＨＡＲＭ
ＬＴＤ．製）を約３００μｌ、これらを混合して顆粒の
血液凝固促進剤を造粒した。得られた顆粒の粒径は３２
ｍｅｓｈ〜６０ｍｅｓｈのものであった。Example 3 200 IU of thrombin as a blood coagulation promoter and 100 m of PVP as a binder
g, snake venom extract (recerase: PENTAPARM)
LTD. Was mixed with each other to obtain a granulated blood coagulation promoter. The particle size of the obtained granules is 32
Mesh to 60 mesh.
【００３９】この顆粒を１本当たり１０ｍｇ封入したポ
リエステル製減圧採血管を作製した（図１参照）。A reduced-pressure blood collection tube made of polyester was prepared by enclosing 10 mg of the granules (see FIG. 1).
【００４０】（実施例４）血液凝固促進剤として、トロ
ンビン２００ＩＵ、バインダーとしてＰＶＰを１００ｍ
ｇ、これらを混合して顆粒の血液凝固促進剤を造粒し
た。得られた顆粒の粒径は３２ｍｅｓｈ〜６０ｍｅｓｈ
のものであった。Example 4 200 IU of thrombin as a blood coagulation promoter and 100 m of PVP as a binder
g, and these were mixed to form a granulated blood coagulation promoter. The particle size of the obtained granules is from 32 mesh to 60 mesh.
It was.
【００４１】ポリエステル製減圧採血管の底部に、血清
分離剤としてオレフィン系樹脂無機充填剤を配合したも
の１．６ｍｌをノズルの後方から圧力をかけて押出し採
血管内へ充填し、血清分離剤が存在する側と空間を２分
するように、円形に打ち抜いたＰＥＴ製フィルムを挿入
した。At the bottom of a polyester vacuum blood collection tube, 1.6 ml of an olefin resin inorganic filler compounded as a serum separating agent was extruded by applying pressure from the back of the nozzle and filled into the blood collection tube. A PET film punched out in a circular shape was inserted so as to divide the side to be cut and the space into two.
【００４２】前述の顆粒をフィルムの上部に１本当たり
１０ｍｇ封入した減圧採血管を作製した（図２参照）。A vacuum blood collection tube was prepared by enclosing the above-mentioned granules at the upper part of the film in an amount of 10 mg per tube (see FIG. 2).
【００４３】（実施例５）血液凝固促進剤として、トロ
ンビン２００ＩＵ、バインダーとしてＰＶＰを１００ｍ
ｇ、これらを混合して顆粒の血液凝固促進剤を造粒し
た。得られた顆粒の粒径は３２ｍｅｓｈ〜６０ｍｅｓｈ
のものであった。Example 5 200 IU of thrombin as a blood coagulation promoter and 100 m of PVP as a binder
g, and these were mixed to form a granulated blood coagulation promoter. The particle size of the obtained granules is from 32 mesh to 60 mesh.
It was.
【００４４】ポリエステル製減圧採血管の底部に、実施
例４と同様に血清分離剤を充填し、水にとかした水溶性
シリコーン１００ｍｇを血清分離剤表面に噴霧し風乾す
ることにより塗布した。A serum separating agent was filled in the bottom of the vacuum blood collection tube made of polyester in the same manner as in Example 4, and 100 mg of water-soluble silicone dissolved in water was sprayed on the surface of the serum separating agent and applied by air drying.
【００４５】前述の顆粒を１本当たり１０ｍｇ封入した
減圧採血管を作製した。A vacuum blood collection tube containing 10 mg of the above granules was prepared.
【００４６】（実施例６）血液凝固促進剤として、トロ
ンビン２００ＩＵ、バインダーとしてＰＶＰを１００ｍ
ｇ、これらを混合して顆粒の血液凝固促進剤を造粒し
た。得られた顆粒の粒径は３２ｍｅｓｈ〜６０ｍｅｓｈ
のものであった。Example 6 200 IU of thrombin as a blood coagulation promoter and 100 m of PVP as a binder
g, and these were mixed to form a granulated blood coagulation promoter. The particle size of the obtained granules is from 32 mesh to 60 mesh.
It was.
【００４７】水溶性シリコーンを５％濃度になるよう適
切な有機溶媒に溶解させた溶液に造粒した顆粒を浸した
後、取り出して風乾することにより顆粒の表面に水溶性
シリコーンを塗布した。The granulated granules were immersed in a solution prepared by dissolving a water-soluble silicone in a suitable organic solvent to a concentration of 5%, taken out and air-dried to apply the water-soluble silicone to the surface of the granules.
【００４８】ポリエステル製減圧採血管の底部に、実施
例４と同様に血清分離剤を充填し、血清分離剤の上に前
述の顆粒を１本当たり１０ｍｇ封入した減圧採血管を作
製した（図３参照）。The bottom of the vacuum blood collection tube made of polyester was filled with a serum separating agent in the same manner as in Example 4, and a vacuum blood collecting tube in which 10 mg of the above-mentioned granules were sealed on the serum separating material was prepared (FIG. 3). reference).
【００４９】（実施例７）血液凝固促進剤として、トロ
ンビン２００ＩＵ、バインダーとしてＰＶＰを１００ｍ
ｇ、水溶性シリコーン５ｍｇ、これらを混合して顆粒の
血液凝固促進剤を造粒した。得られた顆粒の粒径は３２
ｍｅｓｈ〜６０ｍｅｓｈのものであった。(Example 7) 200 IU of thrombin as a blood coagulation promoter and 100 m of PVP as a binder
g, 5 mg of water-soluble silicone, and these were mixed to granulate a blood coagulation accelerator. The particle size of the obtained granules is 32
Mesh to 60 mesh.
【００５０】ポリエステル製減圧採血管の底部に、実施
例４と同様に血清分離剤を充填し、血清分離剤の上にこ
の顆粒を１本当たり１０ｍｇ封入した減圧採血管を作製
した。The bottom of the polyester vacuum blood collection tube was filled with a serum separating agent in the same manner as in Example 4, and a vacuum blood collecting tube was prepared by enclosing 10 mg of the granules on the serum separating agent.
【００５１】（比較例１）空のガラス製減圧採血管を作
製した。(Comparative Example 1) An empty glass blood collection tube was prepared.
【００５２】（比較例２）空のポリエステル製減圧採血
管を作製した。(Comparative Example 2) An empty polyester vacuum blood collection tube was prepared.
【００５３】（凝固時間の測定）上記の減圧採血管を用
い、人より９ｍｌの採血を行い血液の凝固時間を観察し
た。(Measurement of Coagulation Time) Using the above-mentioned blood collection tube under reduced pressure, 9 ml of blood was collected from a human, and the coagulation time of the blood was observed.
【００５４】血液凝固完了時点の見極めは、採血管を横
に倒し血液の流動性を確認、流動性が無くなった時点を
血液の血液凝固完了時とした。採血後は１２００Ｇの強
さで１０分間の遠心分離を行い血清の分離を行った。The blood coagulation was completed when the blood collection tube was turned over and the fluidity of the blood was confirmed. When the fluidity disappeared, the blood coagulation was completed. After blood collection, the serum was separated by centrifugation at 1200 G for 10 minutes.
【００５５】各実施例及び比較例の結果を（表１）に示
す。Table 1 shows the results of the examples and the comparative examples.
【００５６】[0056]
【表１】 [Table 1]
【００５７】[0057]
【発明の効果】本発明により、バインダーを用いて顆粒
を形成することで、血液への溶解速度をコントロールす
ることができ、血液の凝固速度も同時にコントロールす
ることが可能となる。According to the present invention, by forming granules using a binder, the dissolution rate in blood can be controlled, and the coagulation rate of blood can be controlled at the same time.
【００５８】また、血液凝固促進剤を顆粒状にすること
で容易に管体に封入し効率よく生産でき、血液凝固促進
剤の塗布や凍結乾燥の工程等が不必要となり製造効率の
高い製品が提供できる。In addition, by granulating the blood coagulation accelerator, the product can be easily encapsulated in a tube and efficiently produced, and the process of applying the blood coagulation accelerator or freeze-drying is unnecessary, so that a product with high production efficiency can be obtained. Can be provided.
【００５９】前述の実施例によれば、顆粒に含まれたバ
インダーの作用により血液凝固促進剤が徐々に溶解する
ことでムラなく確実に凝固を完了することができ、血液
凝固速度にばらつきが生じない。According to the above-described embodiment, the blood coagulation accelerator is gradually dissolved by the action of the binder contained in the granules, so that the coagulation can be completed without unevenness and the blood coagulation speed varies. Absent.
【００６０】さらに採血管内に血清分離剤が封入される
場合は、プラスチック製フィルムによって空間を２分
し、それぞれの空間に血液凝固促進剤と血清分離剤を存
在させることで両者の接触を防止できる。また、水溶性
シリコーンを血清分離剤や顆粒に塗布したり、顆粒の中
に混合することによっても、血液凝固促進剤が血清分離
剤に接着しないように、または血清分離剤中に捕捉され
ないように工夫でき、長期保存後でも血液凝固促進能の
低下を防ぐことを可能にし、血液凝固時間に誤差を生じ
ることがない。Further, when the serum separating agent is enclosed in the blood collection tube, the space can be divided into two by a plastic film, and the blood coagulation accelerator and the serum separating agent can be present in each space to prevent contact between the two. . Also, by applying the water-soluble silicone to the serum separating agent or the granules, or by mixing the granules in the granules, the blood coagulation promoting agent is prevented from adhering to the serum separating agent or being trapped in the serum separating agent. It is possible to devise and prevent a decrease in blood coagulation promoting ability even after long-term storage, so that no error occurs in blood coagulation time.
【００６１】上述の通り、血液凝固促進剤を顆粒状とす
ることにより、その血液凝固促進能を十分作用させるこ
とができ、ガラス管と同等もしくはそれ以上の血液凝固
促進能が得られ、従来のような複雑な製造工程を要しな
い減圧採血管を得ることができる。As described above, by making the blood coagulation accelerator granular, the blood coagulation accelerating ability can be sufficiently exerted, and a blood coagulation accelerating ability equal to or higher than that of a glass tube can be obtained. A reduced-pressure blood collection tube that does not require such a complicated manufacturing process can be obtained.
【図１】本発明の一実施例の減圧採血管を説明するため
の中央断面図である。FIG. 1 is a central sectional view for explaining a reduced-pressure blood collection tube according to one embodiment of the present invention.
【図２】本発明の一実施例の減圧採血管を説明するため
の中央断面図である。FIG. 2 is a central sectional view for explaining a reduced-pressure blood collection tube according to one embodiment of the present invention.
【図３】本発明の一実施例の減圧採血管を説明するため
の中央断面図である。FIG. 3 is a central sectional view illustrating a reduced-pressure blood collection tube according to an embodiment of the present invention.
Claims (7)
とを特徴とする採血管。1. A blood collection tube in which granules containing a blood coagulation promoter are encapsulated.
固活性を有する物質のいずれかまたはその組み合わせで
ある請求項１に記載の採血管。2. The blood collection tube according to claim 1, wherein the blood coagulation promoter is an inorganic substance or a substance having a blood coagulation activity or a combination thereof.
たは珪藻土やカオリン等のＳｉＯ2を含む混合物である
請求項２に記載の採血管。3. The blood collection tube according to claim 2, wherein the inorganic substance is silica particles, glass powder, or a mixture containing SiO 2 such as diatomaceous earth and kaolin.
ビン、トロンビン様酵素、またはそれらを含む蛇毒抽出
物質である請求項２に記載の採血管。4. The blood collection tube according to claim 2, wherein the substance having a blood coagulation activity is thrombin, a thrombin-like enzyme, or a snake venom extract containing them.
からなる請求項１に記載の採血管。5. The blood collection tube according to claim 1, wherein the granules comprise a blood coagulation promoter and a binder.
ン、ポリビニルアルコール等の水溶性物質、カルボキシ
メチルセルロース、ヒドロキシエチルセルロース、ヒド
ロキシプロピルセルロース、エチルヒドロキシエチルセ
ルロース、エチルセルロース、メチルセルロース、カル
ボキシメチルエチルセルロース、ヒドロキシプロピルメ
チルセルロース等の水溶性セルロース誘導体、２−ヒド
ロキシエチルアクリレート、２−ヒドロキシプロピルア
クリレート等の水溶性アクリル酸誘導体、ゼラチン、で
んぷん等の水溶性多種タンパク質の混合物質からなる群
のいずれか１種以上の物質を含む請求項５に記載の採血
管。6. The binder is a water-soluble substance such as polyvinylpyrrolidone and polyvinyl alcohol, and a water-soluble cellulose such as carboxymethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, ethylhydroxyethylcellulose, ethylcellulose, methylcellulose, carboxymethylethylcellulose and hydroxypropylmethylcellulose. 6. The composition according to claim 5, which comprises at least one substance selected from the group consisting of a derivative, a water-soluble acrylic acid derivative such as 2-hydroxyethyl acrylate and 2-hydroxypropyl acrylate, and a mixed substance of water-soluble multi-proteins such as gelatin and starch. Blood collection tube as described.
液凝固促進剤が血清分離剤に接着しないように、または
捕捉されないように封入された請求項１に記載の採血
管。7. The blood collection tube according to claim 1, wherein a serum separating agent is sealed in the blood collection tube, and the blood coagulation promoter is sealed so as not to adhere to or be trapped by the serum separating agent.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP10165745A JP2000000228A (en) | 1998-06-12 | 1998-06-12 | Blood specimen collection tube |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP10165745A JP2000000228A (en) | 1998-06-12 | 1998-06-12 | Blood specimen collection tube |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| JP2000000228A true JP2000000228A (en) | 2000-01-07 |
Family
ID=15818279
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP10165745A Pending JP2000000228A (en) | 1998-06-12 | 1998-06-12 | Blood specimen collection tube |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP2000000228A (en) |
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