JPH1164332A - Blood coagulation promoter - Google Patents
Blood coagulation promoterInfo
- Publication number
- JPH1164332A JPH1164332A JP9224771A JP22477197A JPH1164332A JP H1164332 A JPH1164332 A JP H1164332A JP 9224771 A JP9224771 A JP 9224771A JP 22477197 A JP22477197 A JP 22477197A JP H1164332 A JPH1164332 A JP H1164332A
- Authority
- JP
- Japan
- Prior art keywords
- blood coagulation
- aqueous solution
- accelerator
- blood
- silica
- 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
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- Investigating Or Analysing Biological Materials (AREA)
Abstract
Description
【０００１】[0001]
【発明の属する技術分野】本発明は、血液凝固促進剤に
関する。[0001] The present invention relates to a blood coagulation promoter.
【０００２】[0002]
【従来の技術】現在、血清生化学検査、血清免疫学検査
などの血液検査が普及し、病気の予防や診断に大きく貢
献している。この検査に用いられる血清は、採血管に採
取した血液を凝固させた後、遠心分離させることにより
得られる。上記の採血管には、ガラス製、プラスチック
製のものが使用されているが、血液が注入された後の凝
固に、ガラスの場合で４０〜６０分、プラスチックの場
合は４時間以上かかるという問題がある。2. Description of the Related Art At present, blood tests such as serum biochemical tests and serum immunological tests have become widespread, and have greatly contributed to the prevention and diagnosis of diseases. The serum used for this test is obtained by coagulating blood collected in a blood collection tube and centrifuging the blood. The blood collection tube is made of glass or plastic, but it takes 40 to 60 minutes for glass and 4 hours or more for plastic for coagulation after blood is injected. There is.
【０００３】この凝固時間を短縮するために、一般に血
液凝固促進剤が用いられている。血液凝固促進剤として
は、種々のものが使用されているが、例えば、特公平１
−２６５０４号公報には、シリカ微粉末、アルコール変
性シリコーンオイル及びポリビニルピロリドン水溶液か
らなる組成物が開示されている。この血液凝固促進剤
は、一般に、採血管の内壁に塗布されて使用されるが、
上記組成物のうち、アルコール変性シリコーンオイル及
びポリビニルピロリドンは、血液の凝固した血餅が採血
管の内壁に固着するのを防止するために配合されてい
る。In order to shorten the coagulation time, a blood coagulation promoter is generally used. Various blood coagulation promoters have been used.
No. 26504 discloses a composition comprising silica fine powder, alcohol-modified silicone oil and an aqueous solution of polyvinylpyrrolidone. This blood coagulation promoter is generally used by being applied to the inner wall of a blood collection tube,
Among the above compositions, alcohol-modified silicone oil and polyvinylpyrrolidone are blended to prevent blood clots from sticking to the inner wall of the blood collection tube.
【０００４】しかしながら、この血液凝固促進剤は水に
溶解されているため、種々の細菌等の微生物が繁殖しや
すいという問題があった。このため、滅菌の方法とし
て、防腐剤の添加、γ線滅菌、電子線照射滅菌などが考
えられるが、防腐剤の添加では得られた血清に防腐剤が
混入し検査値への影響が懸念され、γ線や電子線を用い
る方法では血液凝固促進剤中のシリコーンオイル及びポ
リビニルピロリドンが変性しヘドロ状の析出物が生成す
るという問題があった。[0004] However, since this blood coagulation promoter is dissolved in water, there is a problem that microorganisms such as various bacteria easily propagate. For this reason, sterilization methods such as the addition of preservatives, γ-ray sterilization, and electron beam irradiation sterilization can be considered. In the method using γ-rays or electron beams, there is a problem that silicone oil and polyvinylpyrrolidone in the blood coagulation accelerator are denatured to form sludge-like precipitates.
【０００５】[0005]
【発明が解決しようとする課題】本発明は、上記問題点
を解決するものであり、その目的は血液凝固促進剤の品
質に影響を与えることなく滅菌処理された血液凝固促進
剤を提供することにある。SUMMARY OF THE INVENTION The present invention has been made to solve the above problems, and an object of the present invention is to provide a blood coagulation accelerator which is sterilized without affecting the quality of the blood coagulation accelerator. It is in.
【０００６】[0006]
【課題を解決するための手段】本発明の血液凝固促進剤
は、シリカ及びポリビニルピロリドン水溶液を含有する
血液凝固促進剤であって、５５〜８０℃で１分〜７２時
間加温処理されたことを特徴とする。The blood coagulation promoter of the present invention is a blood coagulation promoter containing silica and an aqueous solution of polyvinylpyrrolidone, which is heated at 55 to 80 ° C. for 1 minute to 72 hours. It is characterized by.
【０００７】本発明で用いられるシリカは、粒径が５０
μｍ以下であって、平均粒径が１０μｍ以下であるもの
が好ましい。The silica used in the present invention has a particle size of 50.
It is preferable that the average particle diameter is 10 μm or less.
【０００８】本発明で用いられるポリビニルピロリドン
は、血餅が採血管の内壁に固着するのを防止するために
使用されるが、その種類としては特に限定されず、従来
から血液凝固促進剤に使用されてきたポリビニルピロリ
ドンが、いずれも使用可能である。[0008] The polyvinylpyrrolidone used in the present invention is used to prevent a blood clot from sticking to the inner wall of a blood collection tube. Any of polyvinylpyrrolidone that has been used can be used.
【０００９】本発明の血液凝固促進剤には、血餅が採血
管の内壁に固着するのを防止するために、親水性シリコ
ーンオイルが配合されてもよい。親水性シリコーンオイ
ルとしては、例えば、アルコール変性シリコーンオイル
が挙げられる。上記親水性シリコーンオイルとしては、
特に限定されず、従来から血液凝固促進剤に使用されて
きたものが、いずれも使用可能である。The blood coagulation accelerator of the present invention may contain a hydrophilic silicone oil in order to prevent the blood clot from sticking to the inner wall of the blood collection tube. Examples of the hydrophilic silicone oil include an alcohol-modified silicone oil. As the hydrophilic silicone oil,
There is no particular limitation, and any of those conventionally used as blood coagulation promoters can be used.
【００１０】本発明の血液凝固促進剤の製造方法の一例
を挙げると、 まず、ポリビニルピロリドンの水溶液を調製する。上
記水溶液のポリビニルピロリドン濃度としては、４×１
０-6〜２０ｗ／ｖ％が好ましい。次いで、この水溶液に
水酸化リチウムを添加してｐＨを６．５〜７．５の範囲
に調整する。 この水溶液にシリカを添加し、攪拌混合する。添加す
るシリカの量は、添加後の水分散液中のシリカの濃度が
４×１０-4〜２０ｗ／ｖ％となるようにすることが好ま
しい。 この水分散液を密閉容器に入れ、容器ごと乾燥器に入
れ、水分散液の温度を５５〜８０℃まで加温し、１分〜
７２時間保持する。この温度が低くなる、又はこの時間
が短くなると、滅菌が不十分となり易く、この温度が高
くなる、又はこの時間が長くなると、血液凝固促進剤が
変性し易くなる。より好ましい条件は、７０〜８０℃、
１〜２時間であり、最も好ましい条件は、７５℃で２時
間程度である。As an example of the method for producing the blood coagulation promoter of the present invention, first, an aqueous solution of polyvinylpyrrolidone is prepared. The concentration of polyvinylpyrrolidone in the aqueous solution was 4 × 1
0 -6 ~20w / v% is preferred. Next, lithium hydroxide is added to the aqueous solution to adjust the pH to a range of 6.5 to 7.5. Silica is added to this aqueous solution and mixed with stirring. It is preferable that the amount of silica to be added is such that the concentration of silica in the aqueous dispersion after the addition is 4 × 10 −4 to 20 w / v%. This aqueous dispersion is placed in a closed container, and the whole container is placed in a dryer, and the temperature of the aqueous dispersion is heated to 55 to 80 ° C., and 1 minute to
Hold for 72 hours. If this temperature is lowered or this time is shortened, sterilization tends to be insufficient, and if this temperature is raised or this time is prolonged, the blood coagulation promoter tends to be denatured. More preferred conditions are 70-80 ° C,
1 to 2 hours, and the most preferable condition is about 2 hours at 75 ° C.
【００１１】本発明の血液凝固促進剤に必要に応じて親
水性シリコーンオイルが配合される場合、上記血液凝固
促進剤中の濃度としては、４×１０-6〜１０ｗ／ｖ％が
好ましい。When a hydrophilic silicone oil is added to the blood coagulation promoter of the present invention as required, the concentration in the blood coagulation promoter is preferably 4 × 10 −6 to 10 w / v%.
【００１２】本発明の血液凝固促進剤は、採血された血
液の収容された容器に添加されて使用されてもよいし、
予め採血管に収容されていてもよい。予め採血管に収容
される場合には、収容後、水が乾燥により蒸発されても
よい。The blood coagulation accelerator of the present invention may be used by being added to a container containing collected blood,
It may be stored in a blood collection tube in advance. In the case where the blood is previously stored in the blood collection tube, the water may be evaporated by drying after the storage.
【００１３】[0013]
【作用】シリカ及びポリビニルピロリドン水溶液を含有
する血液凝固促進剤は、γ線や電子線を用いたり、高温
で滅菌すると、血液凝固促進剤中のポリビニルピロリド
ンやシリコーンオイルが変性しヘドロ状の析出物が生成
するという問題があったが、５５〜８０℃で１分〜７２
時間の加温処理であれば、血液凝固促進剤が変性される
ことなく滅菌される。従って、本発明の血液凝固促進剤
は良好な血液凝固促進機能を有するとともに、滅菌処理
されている。The blood coagulation accelerator containing silica and polyvinylpyrrolidone aqueous solution, when used with γ-rays or electron beams or when sterilized at high temperature, denatures polyvinylpyrrolidone and silicone oil in the blood coagulation accelerator and forms a sludge-like precipitate. However, at 55 to 80 ° C. for 1 minute to 72
If the heating treatment is performed for a long time, the blood coagulation promoter is sterilized without being denatured. Therefore, the blood coagulation promoter of the present invention has a good blood coagulation promoting function and is sterilized.
【００１４】[0014]
【発明の実施の形態】次に、本発明の実施例を説明す
る。 （実施例１）ポリビニルピロリドン（和光純薬社製、Ｋ
−３０）２０ｇ、及びアルコール変性シリコーンオイル
（東レダウコーニング社製、ＳＦ８４２７）２０ｇを９
３５ｍｌの水に溶解し、これに水酸化リチウムを添加し
てｐＨを６．９に調整した。この溶液に、シリカ（和光
純薬社製、粒径は４００メッシュ通過のもの）２５ｇを
添加し、十分に分散させて血液凝固促進剤を調製した。Next, embodiments of the present invention will be described. (Example 1) Polyvinylpyrrolidone (manufactured by Wako Pure Chemical Industries, K
-30) 20 g and 20 g of alcohol-modified silicone oil (manufactured by Toray Dow Corning Co., Ltd., SF8427).
It was dissolved in 35 ml of water, and the pH was adjusted to 6.9 by adding lithium hydroxide. To this solution, 25 g of silica (manufactured by Wako Pure Chemical Industries, Ltd., having a particle size of 400 mesh) was added and sufficiently dispersed to prepare a blood coagulation promoter.
【００１５】この血液凝固促進剤を、１リットルのポリ
プロピレン製容器に入れ、蓋を開放して室温条件下で２
４時間放置した。なお、この処置は、実験のために意図
的に微生物汚染をさせるための処置である。次いで、こ
の血液凝固促進剤を乾燥器内に入れ、容器内の血液凝固
促進剤の温度が７５℃になったのを確認後、２時間放置
した。このようにして、本発明の血液凝固促進剤を得
た。This blood coagulation promoter is placed in a 1-liter polypropylene container, and the lid is opened.
Left for 4 hours. This treatment is a treatment for intentionally causing microbial contamination for an experiment. Next, the blood coagulation promoter was put into a dryer, and after confirming that the temperature of the blood coagulation promoter in the container had reached 75 ° C., it was left for 2 hours. Thus, the blood coagulation promoter of the present invention was obtained.
【００１６】（実施例２）７５℃での放置時間を７２時
間とした他は、実施例１と同様にして本発明の血液凝固
促進剤を得た。(Example 2) A blood coagulation promoter of the present invention was obtained in the same manner as in Example 1 except that the standing time at 75 ° C was 72 hours.
【００１７】（比較例１）血液凝固促進剤に加熱滅菌処
理をしなかったことの他は、実施例１と同様にして血液
凝固促進剤を得た。Comparative Example 1 A blood coagulation accelerator was obtained in the same manner as in Example 1, except that the blood coagulation accelerator was not subjected to heat sterilization.
【００１８】（比較例２）血液凝固促進剤に、加熱滅菌
処理をすることの代わりに、γ線滅菌処理をしたことの
他は、実施例１と同様にして血液凝固促進剤を得た。Comparative Example 2 A blood coagulation accelerator was obtained in the same manner as in Example 1 except that the blood coagulation accelerator was subjected to γ-ray sterilization instead of heat sterilization.
【００１９】（比較例３）血液凝固促進剤に、加熱滅菌
処理をすることの代わりに、電子線滅菌処理をしたこと
の他は、実施例１と同様にして血液凝固促進剤を得た。Comparative Example 3 A blood coagulation accelerator was obtained in the same manner as in Example 1 except that the blood coagulation accelerator was subjected to electron beam sterilization instead of heat sterilization.
【００２０】（比較例４）加熱滅菌処理条件を、３０℃
×２時間とした他は、実施例１と同様にして血液凝固促
進剤を得た。(Comparative Example 4) Heat sterilization conditions were 30 ° C.
A blood coagulation promoter was obtained in the same manner as in Example 1 except that the time was × 2 hours.
【００２１】（比較例５）加熱滅菌処理条件を、１００
℃×２時間とした他は、実施例１と同様にして血液凝固
促進剤を得た。(Comparative Example 5) Heat sterilization conditions were set to 100
A blood coagulation promoter was obtained in the same manner as in Example 1 except that the temperature was changed to 2 hours at ° C.
【００２２】性能評価 実施例１、２及び比較例１〜５で得られた血液凝固促進
剤の性能評価を以下のようにして行った。Performance Evaluation The performance evaluation of the blood coagulation accelerators obtained in Examples 1 and 2 and Comparative Examples 1 to 5 was performed as follows.
【００２３】性能評価１ 得られた血液凝固促進剤の１ｍｌを、ポアサイズ０．４
５μｍのフィルターを用いて吸引濾過し、濾過後のフィ
ルターを真菌用の専用培地又は細菌用の専用培地にのせ
（フィルター及び培地はミリポア社製の専用キット「ミ
リフレックス−１００」を使用、なお、真菌用の培地は
ＷＬ ｎｕｔｒｉｅｎｔ培地、細菌用の培地はＴＧＥ培
地である）、３０℃で５日間培養した。培養終了後、生
育したコロニー数を計測した。Performance Evaluation 1 1 ml of the obtained blood coagulation accelerator was used with a pore size of 0.4
Suction filtration is performed using a 5 μm filter, and the filter after filtration is placed on a dedicated medium for fungi or a dedicated medium for bacteria. The culture medium for fungi was a WL nutrient medium, and the culture medium for bacteria was a TGE medium) at 30 ° C. for 5 days. After completion of the culture, the number of grown colonies was counted.
【００２４】性能評価２ 得られた血液凝固促進剤を、１５０メッシュのフィルタ
ーで濾過しフィルター上に残った異物の状態を観察し
た。Performance Evaluation 2 The obtained blood coagulation accelerator was filtered through a 150-mesh filter, and the state of foreign substances remaining on the filter was observed.
【００２５】性能評価３ 得られた血液凝固促進剤を、１０ｍｌ用（φ１５．１ｍ
ｍ×１００ｍｍ）のポリエチレンテレフタレート製採血
管に２０μｌ注入後、５５℃のオーブンで１時間乾燥し
て水を蒸発させた。上記乾燥後の採血管に、血液を５ｍ
ｌ入れ凝固時間（採血管を横向きにしても血餅部が流れ
なくなるまでの時間）を測定した。Performance Evaluation 3 The obtained blood coagulation accelerator was used for 10 ml (φ15.1 m
After injection of 20 μl into a polyethylene terephthalate blood collection tube (m × 100 mm), it was dried in an oven at 55 ° C. for 1 hour to evaporate water. 5 m of blood is collected into the blood collection tube after drying.
The ligation coagulation time (the time until the clot no longer flows even when the blood collection tube was turned sideways) was measured.
【００２６】性能評価〜の評価結果を表１に示し
た。Table 1 shows the results of the performance evaluations.
【００２７】[0027]
【表１】 [Table 1]
【００２８】[0028]
【発明の効果】本発明の血液凝固促進剤の構成は上記の
通りであり、血液凝固促進剤の品質に影響を与えること
なく滅菌処理された血液凝固促進剤が提供される。The composition of the blood coagulation promoter of the present invention is as described above, and a blood coagulation promoter sterilized without affecting the quality of the blood coagulation promoter is provided.
フロントページの続き (72)発明者 中野 慎也 山口県新南陽市開成町4560 積水化学工業 株式会社内Continued on the front page (72) Inventor Shinya Nakano 4560 Kaiseicho, Shinnanyo-shi, Yamaguchi Prefecture Sekisui Chemical Co., Ltd.
Claims (1)
を含有する血液凝固促進剤であって、５５〜８０℃で１
分〜７２時間加温処理されたことを特徴とする血液凝固
促進剤。1. A blood coagulation accelerator containing silica and an aqueous solution of polyvinylpyrrolidone, wherein the
A blood coagulation promoter, which has been heated for from minutes to 72 hours.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP9224771A JPH1164332A (en) | 1997-08-21 | 1997-08-21 | Blood coagulation promoter |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP9224771A JPH1164332A (en) | 1997-08-21 | 1997-08-21 | Blood coagulation promoter |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| JPH1164332A true JPH1164332A (en) | 1999-03-05 |
Family
ID=16818967
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP9224771A Pending JPH1164332A (en) | 1997-08-21 | 1997-08-21 | Blood coagulation promoter |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPH1164332A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2001322926A (en) * | 2000-05-12 | 2001-11-20 | Sekisui Chem Co Ltd | Blood coagulation promoter composition sprayer |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH05196560A (en) * | 1991-06-12 | 1993-08-06 | Ppg Ind Inc | Sealed glass container, which can undergo sterilization and manufacture thereof |
| JPH07113805A (en) * | 1993-10-15 | 1995-05-02 | Konica Corp | Producing method of reference standard for immunoreaction measurement and immunologic measuring method using the same |
| JPH08105885A (en) * | 1994-10-05 | 1996-04-23 | Sekisui Chem Co Ltd | Blood coagulation promoter, blood coagulation promotion method and blood test container thereof |
| JPH08266217A (en) * | 1995-03-30 | 1996-10-15 | Hayashida Shokuhin Sangyo Kk | Sterilization of salted roe |
-
1997
- 1997-08-21 JP JP9224771A patent/JPH1164332A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH05196560A (en) * | 1991-06-12 | 1993-08-06 | Ppg Ind Inc | Sealed glass container, which can undergo sterilization and manufacture thereof |
| JPH07113805A (en) * | 1993-10-15 | 1995-05-02 | Konica Corp | Producing method of reference standard for immunoreaction measurement and immunologic measuring method using the same |
| JPH08105885A (en) * | 1994-10-05 | 1996-04-23 | Sekisui Chem Co Ltd | Blood coagulation promoter, blood coagulation promotion method and blood test container thereof |
| JPH08266217A (en) * | 1995-03-30 | 1996-10-15 | Hayashida Shokuhin Sangyo Kk | Sterilization of salted roe |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2001322926A (en) * | 2000-05-12 | 2001-11-20 | Sekisui Chem Co Ltd | Blood coagulation promoter composition sprayer |
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