JPS63184060A - Examination test paper - Google Patents
Examination test paperInfo
- Publication number
- JPS63184060A JPS63184060A JP1643287A JP1643287A JPS63184060A JP S63184060 A JPS63184060 A JP S63184060A JP 1643287 A JP1643287 A JP 1643287A JP 1643287 A JP1643287 A JP 1643287A JP S63184060 A JPS63184060 A JP S63184060A
- Authority
- JP
- Japan
- Prior art keywords
- test
- layer
- reagent layer
- color tone
- test reagent
- 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
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- 239000000049 pigment Substances 0.000 description 1
- 239000002985 plastic film Substances 0.000 description 1
- 229920006255 plastic film Polymers 0.000 description 1
- 229920000647 polyepoxide Polymers 0.000 description 1
- 229920001225 polyester resin Polymers 0.000 description 1
- 239000004645 polyester resin Substances 0.000 description 1
- 229920001223 polyethylene glycol Polymers 0.000 description 1
- 229920005596 polymer binder Polymers 0.000 description 1
- 239000002491 polymer binding agent Substances 0.000 description 1
- 229920001282 polysaccharide Polymers 0.000 description 1
- 239000005017 polysaccharide Substances 0.000 description 1
- 229920005990 polystyrene resin Polymers 0.000 description 1
- 229920005749 polyurethane resin Polymers 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 235000010413 sodium alginate Nutrition 0.000 description 1
- 239000000661 sodium alginate Substances 0.000 description 1
- 229940005550 sodium alginate Drugs 0.000 description 1
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 description 1
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 238000005507 spraying Methods 0.000 description 1
- 239000004094 surface-active agent Substances 0.000 description 1
- SFKTYEXKZXBQRQ-UHFFFAOYSA-J thorium(4+);tetrahydroxide Chemical compound [OH-].[OH-].[OH-].[OH-].[Th+4] SFKTYEXKZXBQRQ-UHFFFAOYSA-J 0.000 description 1
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 1
- 210000004885 white matter Anatomy 0.000 description 1
- 239000002888 zwitterionic surfactant Substances 0.000 description 1
Abstract
Description
に産業上の利用分野１
本発明は、体液中の各種成分を簡単に検出し、検出と同
時に検出された成分量の判定を行うことのできる検査用
試験紙に関し、更に詳しくは、体液中のブドウ糖、Ｗ１
白質９体液のＤＨを検出すると同時に被検査液中の濃度
を正確に判定できる検査用試験紙に関するものである。
！従来の技術】
病気の発見９診断、治療に際して、血液、リンパ液、尿
等の体液中に含有される各種成分の有無並びにその吊を
簡単に且つ迅速に知ることは憬めて車装なことである。
例えば尿或いは血液など体液中のブドウ糖の示を迅速に
且つ簡単に知ることは、糖尿病の早期発見９診断並びに
管理に必要不可欠である。また、体液特に尿中の蛋白質
の吊を迅速に且つ簡単に知ることは、腎疾忠の早期発見
及び診断並びに治療に大きな役割を果す。更に、体液特
に尿のＩ）Ｈを正確に知ることは、体液中に蛋白質が存
在するか否かを正確に知ることの手助けとなるほか、腎
占炎。
膀胱炎等を引き起こす細菌尿の可能性を確認することの
手助けとなる。
このように体液特に尿中のブドウ糖、蛋白質。
ｐＨを簡単迅速に検出することは極めて重要であるが、
このためには従来主として検査試薬が含浸された濾紙を
支持体に貼着してなる検査体が用いられてきた。更に製
造工程を簡素化し、大量生産に適した検査体として検査
試薬に高分子結合剤、および吸水性担体等を混合して印
刷またはコーティング適性を有するインキ組成物を調製
し、このインキ組成物を支持体上に印刷（コーティング
を含む）した後乾燥して試験片を製造する方法が提案さ
れている。このようにして得られた検査体の検査試薬層
は、被検査液中の検査目的物質の含有量に応じて色調変
化をするものであって、被検査液への浸漬によって生じ
た呈色を別個の用紙に印刷された判定基準用に作成され
た色調表と対比して検査目的物質の含有吊を検出するも
のである。
一方、これら検査体を被検査液中に浸漬後、別個に設け
られた判定基準用の色調表と対比する場合は、操作が煩
雑であり、かつ検査液自体が着色しているために検査試
薬の被検査液中の検査目的物質との反応によって生じた
色調の変化が正確に検査体の呈色として表われず、判定
基準用の色調表との対比が困難となり、正確な検査がで
きない場合がある。そこで、このような問題を解決する
ために、検査体の基材上に検査試薬を含む検査試薬層と
、該検査試薬層の近傍に、印刷インキによって印刷され
た判定基準用の色調層とを設けた検査体が提案されてい
る。Field of Industrial Application 1 The present invention relates to a test strip that can easily detect various components in body fluids and simultaneously determine the amount of detected components. Glucose, W1
This invention relates to a test strip that can detect the DH of white matter 9 body fluids and at the same time accurately determine the concentration in the fluid to be tested. ! [Prior Art] Disease Discovery 9 When diagnosing or treating a disease, it is rarely necessary to easily and quickly know the presence or absence of various components contained in body fluids such as blood, lymph, urine, etc., and their abundance. be. Quick and easy knowledge of glucose levels in body fluids, such as urine or blood, is essential for early detection, diagnosis and management of diabetes. In addition, quickly and easily determining the level of protein in body fluids, especially urine, plays a major role in early detection, diagnosis, and treatment of kidney disease. Furthermore, accurately knowing I)H in body fluids, especially urine, not only helps in accurately knowing whether or not protein is present in body fluids, but also helps in nephritis. This will help confirm the possibility of bacteriuria causing cystitis, etc. Thus glucose and protein in body fluids, especially urine. Although it is extremely important to detect pH easily and quickly,
For this purpose, a test body has conventionally been mainly used, which is a filter paper impregnated with a test reagent and adhered to a support. Furthermore, to simplify the manufacturing process, as a test material suitable for mass production, an ink composition suitable for printing or coating is prepared by mixing a test reagent with a polymer binder, a water-absorbing carrier, etc., and this ink composition is used. A method of manufacturing a test piece by printing (including coating) on a support and then drying has been proposed. The test reagent layer of the test specimen obtained in this way changes color depending on the content of the test target substance in the test liquid, and the coloration caused by immersion in the test liquid changes. This method detects the presence of the substance to be tested by comparing it with a color tone table prepared for the judgment criteria printed on a separate sheet of paper. On the other hand, after immersing these test specimens in the test liquid, comparing them with a separately provided color table for judgment standards is a complicated operation, and since the test liquid itself is colored, the test reagent When a change in color tone caused by a reaction with the test target substance in the test liquid is not accurately expressed as the coloration of the test sample, making it difficult to compare with the color table for judgment standards, making accurate testing impossible. There is. Therefore, in order to solve this problem, a test reagent layer containing a test reagent is placed on the base material of the test object, and a color tone layer for judgment standards printed with printing ink is placed near the test reagent layer. A test object provided with a test object has been proposed.
上記のように、検査体の基材上に検査試薬層と判定基準
用の色調層との両者を形成したものを被検査液に浸漬し
、検査試薬層の呈色を判定基準用の色調層と比較すれば
検査液の着色等による判定の誤りは避けることができる
。しかしながら従来のように判定基準用の色調層を基材
上に通常のインキを用いて印刷したものは、色調層の印
刷面と検査試薬層表面との表面張力並びに表面の物理的
形状の相違により、検査試薬層表面では均一な呈色が生
じるが、印刷面上には検査液が滴状で付着するのみであ
るので、色調層の色調が不均一となって検査試薬層の呈
色との比較が困難となる欠点がある。
本発明者等は、このような問題点を解決するため検査用
試験紙の基材表面に、被検査液中の検査目的物質の含有
量に応じて色調変化する検査試薬を含む検査試薬層と、
該検査試薬層の近傍に該検査試薬層に含まれる検査試薬
主要成分以外の検査試薬層構成材料を実質的に含み染料
等によって着色された判定基準用の色調層とを設けるこ
とにより、検査試薬層と判定基準用の色、網層との被検
査液による濡れを同一にして被検査液中の検査目的物質
含有量の正確な判定を可能とした体液検査用試験紙を発
明し、特願昭６１−２３９６９６号として出願を行った
。しかしながら、このように検査試薬層と判定基準用の
色調層の被検査液による濡れを同一とじても、過剰の被
検査液が付着すると、両層表面への付着量にかたよりが
生じ、呈色阻害や呈色斑が生じる。
本発明はこのような問題点を解決し、均一な呈色の生じ
る体液検査用試験紙を提供することを目的とする。
に問題点を解決するための手段】
本発明は、上記のように検査用試験紙の基材表面に、被
検査液中の検査目的物質の含有吊に応じて色調変化をす
る検査試薬を含む検査試薬層と、該検査試薬層の近傍に
該検査試薬層に含まれる検査試薬主要成分以外の検査試
薬層構成材料を実質的に含み、染料等によって着色され
た判定基準用の色調層とを設けて検査試薬層と判定基準
用の色調層との被検査液による濡れを同一とすると共に
、検査試薬層と色調層の近傍において該基材表面に高吸
水性部を設けて検査試薬層１色調層に付着した過剰の被
検査液を速やかに吸収除去し、被検査液が均一に付着す
るようにしたことにより上記問題点を解決した。
本発明における該高吸水性部は、基材上において検査試
薬層１色ｉｌ！１層の何れか又は両者と接するように設
けても、また、一定間隔をおいて設けてもよく、両層を
囲むようにする等、設ける位置形状には特に制限はなく
、検査試薬層０色調層の近傍であって、該層に付着した
過剰の被検査液を吸収できるよう形成される。
高吸水性部は好ましくは高吸水性物質を含むインキ組成
物として後述する検査試薬層１色調層と同様に印刷によ
って形成することができる。このようなインキ組成物と
しては、セルロース、デンプン、高吸水性ゲルの如き吸
水性粉末、親水性又は疎水性樹脂、結合剤、皮膜を多孔
性にするための無機充填剤の如き添加剤と溶媒を含むも
のである。本発明に用いられる高吸水性ゲルとしては、
例えばポリビニルアルコール（ＰＶＡ）、アクリル酸塩
、アクリルニトリル、デンプン等を主成分とする架橋、
グラフト共重合体であり、市販されている高吸水性ゲル
としては、吸水能６００倍を有するスミカゲル５Ｐ５２
０ （住友化学工業■より市販のＰＶＡ−アクリル酸
塩ブロックコポリマー）、吸水能１０００倍を有するサ
ンウェットｌＮ−１０００（工注化成■より市販のアク
リル酸グラフ（・デンプン）、同じく吸水能１０００倍
を有するＫｌグル（ＰＶＡ−環状酸無水物との反応生成
物）などを挙げることができる。
本発明における検査用試験紙は、゛例えば体液中のブド
ウ糖検出用試験紙、蛋白検出用試験紙、 ｐＨ検出用試
験紙を含むものであって、検査試薬層と色調層の形成は
、濾紙に試薬組成物を含浸させてなるもの、例えば体液
中のブドウ糖検出用試験紙として、ブドウ糖酸化酵素、
ペルオキシダーゼ。
被酸化性指示薬、緩動剤からなる試薬組成物をゼラチン
を含む水または水−アルコール系溶媒中に溶解又は分散
させ、得られた液にｉ１１紙を含浸させた後、乾燥した
ものを検査試薬層とし、一方、濾紙にゼラチンを含む水
または水−アルコール系溶媒に染料等を溶解分散させて
判定基準用の色調層を製造して、それぞれの濾紙を適宜
裁断してプラスチックフィルムのような基材上に貼付し
て形成することができる。同様に蛋白検出用試薬層、ｐ
Ｈ検出用試薬層も濾紙に含浸させて各検査試薬層。
色調層をそれぞれ製造して同様に形成することができる
。
次に印刷によって基材上に検査試薬層と、色調層を設け
るものとしては、特公昭４４−２５９５３号公報に記載
のように水−アルコール混合溶液に酵素類を予め溶解さ
せ、これに指示薬、ｐ１１緩衝剤、高分子結合剤、およ
び吸水性担体等を混合して、印刷またはコーティング適
性を有するインキ組成物を調製し、このインキ組成物を
基材上に印テ！（コーティングを含む）した後乾燥して
検査試薬層を製造し、一方、判定基準用の色ｉｉｌ！１
Ｍは、高分子結合剤および吸水性担体等を水−アルコー
ル混合溶液に加え、更に染料等を溶解９分散してインキ
組成物とし、このインキ組成物を基材上に印刷すること
によって形成することができる。
更に好ましくは、本発明者が先に出願した特願昭６１−
１０７８７１号明細占に記載のようなブドウ糖検出用イ
ンキ組成物、蛋白質検出用インキ組成物。
ｐＨ測定用インキ組成物をそれぞれ用いて検査試薬層を
製造し、判定基準用の色調層を各検査試薬層の形成に用
いられた結合剤、吸水性粉末及び湿潤剤等をそれぞれ含
み、染料等を溶解又は分散させたインキ組成物によって
印刷して設けることができる。検査試薬層を形成するイ
ンキ組成物は（ａ）糖酸化酵素、ペルオキシダーゼ、被
酸化性指示薬、湿潤剤、感度調節剤、安定剤、 ｐＨ緩
衝剤。
結合剤、及び吸水性粉末からなる試薬組成物が非水溶剤
中に溶解或いは分散されてなるブドウ糖検出用インキ組
成物、
（ｂ）蛋白質誤差を示す指示薬、 ｐＨ緩衝剤、湿潤剤
。
蛋白質吸着性イオン交換体、形態保持剤、結合剤、及び
吸水性粉末からなる試薬組成物が溶剤中に溶解或いは分
散されてなる蛋白質検出用インキ組成物、
（Ｃ） ｐｉｆ指示薬、４級アンモニウム塩又はアミン
塩。
塩基性物質、結合剤、及び吸水性粉末からなる試薬組成
物が、溶剤中に溶解或いは分散されてなるＤｌｌｌｌ測
定用インキ初成
物挙げられ、まず、各インキ組成物の検査試薬主要成分
について述べる。
（ａ）ブドウ糖検出用インキ組成物
体液中のブドウ糖は、グルコースオキシダーゼ等のブド
ウ糖酸化酵素の作用により、空気中の酸素と反応して最
終的にグルコン酸と過酸化水素に酸化される。生成した
過酸化水素は、ペルオキシダーゼの作用により発生期の
酸素を産生じ、この酸素は直ちにグアヤク脂、０−トリ
ジン等の被酸化性指示薬と反応して該指示薬を発色させ
る。この発色の程度により、体液中のブドウ糖の有無並
びにその吊が半定量的に決定される。更に感度調節剤と
してアスコルビン酸の脂肪族カルボン酸エステルを使用
することにより、ブドウ糖検出用検査体の定量性、即ち
、検体中に含まれるブドウ糖濃度と検査試薬部の呈色濃
度との直線性を改良することができる。
安定剤は被酸化性指示薬が大気中の過酸化物質等の作用
を受けて変色するのを防止するためのものであって、ア
スコルビン酸の脂肪酸エステルを安定剤として使用する
ことも可能であるが、他に、公知の抗酸化活性を有する
化合物またはグリセロールエステル類に代表される特定
の界面活性剤或いはこれらの混合物を適宜加えることも
できる。
ρ［１緩罰剤は、上記の被酸化性指示薬がブドウ軸検出
用インキ組成物中で好ましい呈色変化を起すｐＨに保た
れるように添加されるものであって、例えば°クエン酸
とクエン酸ナトリウムとの組合せ等が用いられる。
これら各成分は後述する結合剤及び吸水性粉末と共に水
を実質的に含むことのない芳香族炭化水素、脂肪族ケト
ン、エステル類、低級アルコールを除くアルコール類等
の非水溶媒中に溶解或いは分散される。
（ｂ）蛋白質検出用インキ組成物
蛋白質検出用インキ組成物は、形態保持剤として官能基
としてカルボキシル基を有する水膨潤性樹脂を使用する
。
被検査液の蛋白質の検出は、酸価のｐＨに保たれた蛋白
誤差を示す指示薬に、被検査液中の蛋白質が接すると、
該指示薬と蛋白質とが複合物を形成して、酸性色である
黄色から、塩基性色である青色に変色し、この変色の程
度は被検査液中に存在する蛋白質の吊に対応するので、
この原理を利用Ｊて行われる。
蛋白誤差を示す指示薬は上記のような原理に従って挙動
する指示薬であるが、具体的には、テトラブロモフェノ
ールブルー、テトラブロモチモールブルー、テトラブロ
モフェノールフタレインエチルエステル、テトラブロモ
ベンズアラニン、ブロモチモールブルー等を用いること
ができる。これらのうちテトラブロモフェノールブルー
が感度的に優れており好ましい。
ｐＨ緩衝剤は、試薬組成物を所定のｐＨ値に保つもので
あれば何れのものでもよく、クエン酸とクエン酸すトリ
ウムとの組合せが好ましく用いられる。
蛋白質吸着性のイオン交換体としては、強酸性陽イオン
交換体（官能基づ０３Ｍ）、弱酸性陽イオン交換体（−
ＣＯＯＮ） 、強塩基性イオン交換体（−Ｎ゛Ｒ，Ｘ−
、−Ｎ” Ｉ ＣＨ３） 、２ （ＣＨ２ＣＨ２叶））
弱塩基陰陽イオン交換体（−Ｎ（Ｒ）２、−ＮＨｆＲ）
、−ＮＨ２など）が用いられ、これらイオン交換体の母
体としては、スチレン系、アクリル系等の合成樹脂、セ
ルロース、シリカ等が用いられる。
形態保持剤としては、印刷された検査試薬部の親水性を
損わず、しかも水に対し非溶解性であるものが使用され
、官能基としてカルボキシル基を有する医薬品の崩壊剤
として知られるカルボキシメチルセルロースカルシウム
セルロースナトリウム
吸水性ゲルが挙げられる。
上記試薬類と結合剤及び吸水性粉末は芳香族炭化水素，
脂肪族炭化水素，エステル類，アルコール類等の非水溶
媒又は水或いはこれらの混合物に溶解又は分散せしめて
インキ組成物とする。
（ｃ）ｐＨ測定用インキ組成物
体液中のｐＨは、ｐＨによって色調の変わる指示薬によ
って被検査液のｐＨを指示薬の色調を判別することによ
って測定する。
ｐＨ指示薬は、被検査液の水素イオン濃度に応じて色調
の変化する指示薬であればどのような指示薬も使用でき
、また複数種の指示薬を適当に選択または組合わせるこ
とによって、広い範囲のＩ）Ｈ領域を測定することもで
きる。
試薬組成物中に４級アンモニウム塩を′）Ｉ！ｉ示配合
すると、一旦発色された色の経時的な退色現象が大きく
抑制され、かつ、鮮明な色が得られ、また、塩基性物質
を添加するとインキ調製後に酸性物質が溶出してインキ
組成物の色調が経時的に変化をすることを防止できる。
上記試薬類は結合剤及び吸水性粉末と共に芳舌族炭化水
素、脂肪族炭化水素、エステル類、アルコール類などの
非水溶媒または水或いはこれらの混合物中に均一に溶解
或いは分散せしめる。
次に、上記した検査試薬主要成分以外の検査試薬層構成
材料として結合剤及び吸水性粉末について述べるが、こ
れら以外の物質であっても、被検査液中に含まれる成分
によって色調変化を起さない物質であれば、検査試薬層
及び判定基準用の色調層に加えることができ、また、上
記した各成分の中でも被検査液中に含まれる成分によっ
て色調変化を起さないものであれば、色調層中にも加え
ることができる。
結 合 剤
結合剤は、被検査液中の成分及びｐＨ等に影響を及ぼさ
ず、且つ試薬類特に酵素並びに被酸化性指示薬に影響を
及ぼさず、しかも発色反応を妨げないものであることが
要求される。このような要件を満たすことが確かめられ
た結合剤としては、（Ｉ＞ポリエステル樹脂、アルキド
樹脂、ポリウレタン樹脂、ポリスチレン樹脂、アクリル
樹脂。
エポキシ樹脂、塩化ビニル樹脂、塩化ビニル共重合体樹
脂、ポリビニルブチラール樹脂、ポリビニルアルコール
樹脂、ポリビニルピロリドン樹脂。
無水マレイン酸系共重合体等の合成樹脂類、（ｎ）メチ
ルセルロース、エチルセルロース、ヒドロキシエチルセ
ルロース、カルボキシメチルセルロース等のセルロース
誘導体、（Ｉ［［）デンプン、多糖類、ゼラチン、カゼ
イン或いはアルギン酸ナトリウム等の天然高分子等が用
いられる。またこれらの結合剤を二種以上組合せてもよ
い。
吸水性粉末
吸水性粉末の添加は、支持体上に設けられた試薬組成物
の吸水性を高め、被検査液と試：ｇ５絹成物との接触が
促進され、指示薬の呈色反応を促進する働きを有する。
このような吸水性粉末としては、水と接触した場合に、
極端な酸性或いはアルカリ性を示すものは好ましくなく
、しかも白色度の高いものが好ましい。具体的には、カ
オリン、合成シリカ、ガラス、セルロースブロック、微
結晶セルロース、イオン交換セルロース、イオン交換樹
脂、炭酸カルシウム、炭酸マグネシウム、ケイ酸アルミ
ニウム等が用いられうる。
場合によっては、結合剤及び吸水剤のほかに、湿潤剤を
インキ組成物中に配合できる。湿潤剤としては、非イオ
ン界面活性剤、陰イオン界面活性剤、陽イオン界面活性
剤１両性イオン界面活性剤。
ポリエチレングリコール類などが用いられ、この湿潤剤
は、各試薬の分散に役立ち均一な試薬層の形成を促進し
、水ぬれ性を向上させることができる。
本発明における判定基準用の色調層は、上記検査試薬主
要成分以外の検査試薬層構成材料である結合剤、吸水性
粉末、湿潤剤等を検査試薬層を構成するインキ組成物に
用いたと同様の溶媒に溶解或いは分散せしめ、規定濃度
の被検査液に検査試ｉ層を浸漬した際の各濃度における
呈色と一致する色調となるように、染料又は顔料を用い
て着色することによって得られる。
検査試薬層と色調層及び高吸水性部は基材上に各種検査
試薬を含むインキ組成物２芭調層形成インキ組成物及び
高吸水性物質を含むインキ組成物をそれぞれ塗布するこ
とによって形成することができる。
塗布技術としては、印刷法、コーティング法（例えばロ
ールコーティング、スプレーコーティング、ディップコ
ーティング、ベタコーティング）等が用いられうる。イ
ンキ組成物の塗布量が比較的多く且つ塗布量が一定であ
ることが好ましいため、シルクスクリーン印刷法、凹版
印刷法、グラビア印刷法等によって、インキ組成物を基
材上に設けることが好ましい。塗布量は、インキ組成物
の種類に応じて変化するが、一般に２〜１５０ｇ／尻（
乾燥時）であることが好ましい。
基材は、試薬組成物と反応せず、しかも試薬の呈色を阻
害しないものであることが好ましく、具体的には、例え
ば、紙０合成紙、不織布または合成樹脂フィルム或いは
紙と合成樹脂フィルムとの積層体等が用いられる。As described above, a test reagent layer and a color tone layer for judgment standards are formed on the base material of the test object, which is immersed in the liquid to be tested, and the color of the test reagent layer is compared to the color tone layer for judgment standards. If compared with the above, it is possible to avoid errors in judgment due to coloring of the test liquid, etc. However, when the color tone layer for judgment criteria is printed on the base material using ordinary ink as in the past, due to the difference in surface tension and physical shape of the surface between the printed surface of the color tone layer and the surface of the test reagent layer. , a uniform coloration occurs on the surface of the test reagent layer, but since the test liquid only adheres in the form of drops on the printed surface, the color tone of the tone layer becomes uneven and the coloration differs from that of the test reagent layer. There are drawbacks that make comparisons difficult. In order to solve these problems, the present inventors added a test reagent layer containing a test reagent whose color changes depending on the content of the target substance in the test liquid on the surface of the base material of the test strip. ,
By providing in the vicinity of the test reagent layer a color tone layer for judgment standards that substantially contains test reagent layer constituent materials other than the main components of the test reagent contained in the test reagent layer and is colored with a dye or the like, the test reagent Invented a test paper for testing body fluids that made it possible to accurately determine the content of the substance to be tested in the liquid to be tested by making the color of the layer and the judgment standard, and the wetting of the net layer by the liquid to be tested the same, and filed a patent application. The application was filed as No. 1983-239696. However, even if wetting of the test reagent layer and the judgment standard color tone layer by the test liquid is the same, if an excessive amount of test liquid adheres, the amount of adhesion to the surfaces of both layers will be uneven, resulting in Color inhibition and discoloration spots occur. It is an object of the present invention to solve these problems and provide a test strip for testing body fluids that exhibits uniform coloring. Means for Solving the Problems] As described above, the present invention includes, on the surface of the base material of a test strip, a test reagent that changes in color depending on the content of the target substance in the test liquid. A test reagent layer, and a color tone layer for judgment standards that substantially contains test reagent layer constituent materials other than the main components of the test reagent contained in the test reagent layer in the vicinity of the test reagent layer, and is colored with a dye or the like. In addition, a highly water-absorbing portion is provided on the surface of the base material in the vicinity of the test reagent layer and the color tone layer to make the test reagent layer and the judgment reference color tone layer uniformly wetted by the test liquid. The above-mentioned problem was solved by quickly absorbing and removing the excess test liquid adhering to the color tone layer so that the test liquid adhered uniformly. In the present invention, the highly water-absorbent portion has a single color test reagent layer on the base material! There are no particular restrictions on the position and shape of the test reagent layer, and the test reagent layer may be provided in contact with one or both of the layers, or may be provided at regular intervals, or may be provided surrounding both layers. It is formed in the vicinity of the color tone layer so as to be able to absorb excess test liquid adhering to the layer. The highly water-absorbing portion can preferably be formed by printing in the same way as the test reagent layer 1 color tone layer described later as an ink composition containing a highly water-absorbing substance. Such ink compositions include water-absorbing powders such as cellulose, starch, and superabsorbent gels, hydrophilic or hydrophobic resins, binders, additives such as inorganic fillers to make the film porous, and solvents. This includes: The superabsorbent gel used in the present invention includes:
For example, crosslinking based on polyvinyl alcohol (PVA), acrylate, acrylonitrile, starch, etc.
Sumikagel 5P52, which is a graft copolymer and has a water absorption capacity of 600 times, is a commercially available super absorbent gel.
0 (PVA-acrylate block copolymer commercially available from Sumitomo Chemical ■), Sunwet lN-1000 having a water absorption capacity of 1000 times (acrylic acid graph (starch) commercially available from Kochu Kasei ■, also having a water absorption capacity of 1000 times) Examples include Kl-glue (reaction product of PVA-cyclic acid anhydride) having A test paper for detecting pH is formed by impregnating a filter paper with a reagent composition to form a test reagent layer and a color tone layer.For example, as a test paper for detecting glucose in body fluids, glucose oxidase,
Peroxidase. A reagent composition consisting of an oxidizable indicator and a slowing agent is dissolved or dispersed in water or a water-alcoholic solvent containing gelatin, and i11 paper is impregnated with the resulting liquid, and the dried product is used as a test reagent. On the other hand, a color tone layer for judgment standards is manufactured by dissolving and dispersing dyes in water or water-alcoholic solvent containing gelatin on filter paper, and each filter paper is cut as appropriate to form a base layer such as a plastic film. It can be formed by pasting it on a material. Similarly, the protein detection reagent layer, p
The H detection reagent layer is also impregnated into filter paper to form each test reagent layer. Each of the tonal layers can be manufactured and formed similarly. Next, in order to provide a test reagent layer and a color tone layer on the substrate by printing, enzymes are dissolved in advance in a water-alcohol mixed solution as described in Japanese Patent Publication No. 44-25953, and an indicator, An ink composition suitable for printing or coating is prepared by mixing a p11 buffer, a polymeric binder, a water-absorbing carrier, etc., and this ink composition is printed onto a substrate. (including coating) and then drying to produce the test reagent layer, while the color iii! for the criteria! 1
M is formed by adding a polymeric binder, a water-absorbing carrier, etc. to a water-alcohol mixed solution, further dissolving and dispersing a dye, etc. to form an ink composition, and printing this ink composition on a base material. be able to. More preferably, the patent application filed in 1986 by the present inventor is
An ink composition for detecting glucose and an ink composition for detecting protein as described in the specification of No. 107871. A test reagent layer is manufactured using each of the ink compositions for pH measurement, and a color tone layer for determination criteria is prepared, each containing a binder, a water-absorbing powder, a wetting agent, etc. used in the formation of each test reagent layer, and a dye, etc. It can be provided by printing with an ink composition in which is dissolved or dispersed. The ink composition forming the test reagent layer includes (a) sugar oxidase, peroxidase, oxidizable indicator, wetting agent, sensitivity regulator, stabilizer, and pH buffer. An ink composition for glucose detection comprising a binder and a reagent composition comprising a water-absorbing powder dissolved or dispersed in a non-aqueous solvent; (b) an indicator for protein error; a pH buffer; a wetting agent. An ink composition for protein detection, in which a reagent composition comprising a protein-adsorbing ion exchanger, a shape-retaining agent, a binder, and a water-absorbing powder is dissolved or dispersed in a solvent; (C) a pif indicator, a quaternary ammonium salt; or amine salts. Initial compositions of inks for measuring Dllll are prepared by dissolving or dispersing a reagent composition consisting of a basic substance, a binder, and a water-absorbing powder in a solvent. First, the main components of the test reagent of each ink composition will be described. . (a) Glucose detection ink composition Glucose in the liquid reacts with oxygen in the air by the action of glucose oxidase such as glucose oxidase, and is finally oxidized to gluconic acid and hydrogen peroxide. The generated hydrogen peroxide produces nascent oxygen by the action of peroxidase, and this oxygen immediately reacts with an oxidizable indicator such as guaiac butter or O-tolidine to cause the indicator to develop color. Depending on the degree of color development, the presence or absence of glucose in the body fluid and its level are determined semi-quantitatively. Furthermore, by using an aliphatic carboxylic acid ester of ascorbic acid as a sensitivity regulator, it is possible to improve the quantitative properties of the test sample for glucose detection, that is, the linearity between the glucose concentration contained in the sample and the color density of the test reagent part. It can be improved. Stabilizers are used to prevent oxidizable indicators from discoloring due to the action of peroxides in the atmosphere, and fatty acid esters of ascorbic acid can also be used as stabilizers. In addition, compounds having known antioxidant activity, specific surfactants typified by glycerol esters, or mixtures thereof may be added as appropriate. The ρ[1 slowing agent is added so that the above-mentioned oxidizable indicator is maintained at a pH that causes a preferable color change in the ink composition for grape stem detection, and is, for example, citric acid. A combination with sodium citrate, etc. is used. These components are dissolved or dispersed in a non-aqueous solvent such as aromatic hydrocarbons, aliphatic ketones, esters, and alcohols other than lower alcohols that do not substantially contain water, along with the binder and water-absorbing powder described below. be done. (b) Ink composition for protein detection The ink composition for protein detection uses a water-swellable resin having a carboxyl group as a functional group as a shape-retaining agent. Detection of protein in a test solution is carried out when the protein in the test solution comes into contact with an indicator that shows protein error and is maintained at an acid value pH.
The indicator and the protein form a complex and the color changes from acidic yellow to basic blue, and the degree of this color change corresponds to the amount of protein present in the test liquid.
It is carried out using this principle. Indicators that indicate protein errors are indicators that behave according to the principles described above, and specifically include tetrabromophenol blue, tetrabromothymol blue, tetrabromophenolphthalein ethyl ester, tetrabromobenzaalanine, and bromothymol blue. etc. can be used. Among these, tetrabromophenol blue is preferable because it has excellent sensitivity. Any pH buffer may be used as long as it maintains the reagent composition at a predetermined pH value, and a combination of citric acid and thorium citrate is preferably used. Examples of protein-adsorbing ion exchangers include strongly acidic cation exchangers (functional group 03M) and weakly acidic cation exchangers (-
COON), strongly basic ion exchanger (-N゛R,X-
,-N” I CH3) ,2 (CH2CH2 Kano))
Weak base anion cation exchanger (-N(R)2, -NHfR)
, -NH2, etc.), and as the base of these ion exchangers, synthetic resins such as styrene and acrylic resins, cellulose, silica, etc. are used. The shape-preserving agent used is one that does not impair the hydrophilicity of the printed test reagent and is insoluble in water, such as carboxymethylcellulose, which has a carboxyl group as a functional group and is known as a disintegrant for pharmaceuticals. Examples include calcium cellulose sodium water absorbent gel. The above reagents, binder and water-absorbing powder are aromatic hydrocarbons,
An ink composition is prepared by dissolving or dispersing it in a nonaqueous solvent such as an aliphatic hydrocarbon, ester, or alcohol, or water, or a mixture thereof. (c) Ink composition for pH measurement The pH in the liquid is measured by determining the pH of the test liquid using an indicator whose color tone changes depending on the pH. Any pH indicator can be used as long as it changes color depending on the hydrogen ion concentration of the test solution, and by appropriately selecting or combining multiple types of indicators, a wide range of pH indicators can be used. It is also possible to measure the H region. Quaternary ammonium salt in the reagent composition')I! When a basic substance is added, the fading phenomenon over time of a color once developed is greatly suppressed, and a clear color can be obtained.Additionally, when a basic substance is added, an acidic substance is eluted after ink preparation, resulting in a change in the ink composition. It is possible to prevent the color tone from changing over time. The above reagents are uniformly dissolved or dispersed together with a binder and a water-absorbing powder in a non-aqueous solvent such as an aromatic hydrocarbon, an aliphatic hydrocarbon, an ester, an alcohol, water, or a mixture thereof. Next, we will discuss binders and water-absorbing powders as test reagent layer constituent materials other than the main test reagent components mentioned above, but even substances other than these may cause color changes depending on the components contained in the test liquid. If the substance is not present, it can be added to the test reagent layer and the color tone layer for judgment criteria, and among the above-mentioned components, if it does not cause a change in color tone depending on the components contained in the test liquid, It can also be added in the tone layer. Binder The binder is required to be one that does not affect the components and pH etc. in the test solution, does not affect the reagents, especially enzymes and oxidizable indicators, and does not interfere with the color reaction. be done. Binders that have been confirmed to meet these requirements include (I> polyester resin, alkyd resin, polyurethane resin, polystyrene resin, acrylic resin; epoxy resin, vinyl chloride resin, vinyl chloride copolymer resin, polyvinyl butyral) Resin, polyvinyl alcohol resin, polyvinylpyrrolidone resin. Synthetic resins such as maleic anhydride copolymers, (n) cellulose derivatives such as methylcellulose, ethylcellulose, hydroxyethylcellulose, carboxymethylcellulose, (I[[) starch, polysaccharides, Natural polymers such as gelatin, casein, or sodium alginate are used. Two or more of these binders may also be combined. Water-absorbing powder The water-absorbing powder is added to the reagent composition provided on the support. This water-absorbing powder has the function of increasing water absorption, promoting contact between the test liquid and the sample G5 silk composition, and promoting the color reaction of the indicator. ,
Those exhibiting extreme acidity or alkalinity are not preferred, and those with high whiteness are preferred. Specifically, kaolin, synthetic silica, glass, cellulose block, microcrystalline cellulose, ion exchange cellulose, ion exchange resin, calcium carbonate, magnesium carbonate, aluminum silicate, etc. can be used. Optionally, in addition to binders and water-absorbing agents, wetting agents can be included in the ink composition. Wetting agents include nonionic surfactants, anionic surfactants, cationic surfactants, and zwitterionic surfactants. Polyethylene glycols and the like are used, and this wetting agent helps disperse each reagent, promotes the formation of a uniform reagent layer, and can improve water wettability. In the present invention, the color tone layer for judgment criteria is similar to that used in the ink composition constituting the test reagent layer, such as a binder, water-absorbing powder, wetting agent, etc., which are test reagent layer constituent materials other than the above-mentioned main test reagent components. It is obtained by dissolving or dispersing it in a solvent and coloring it with a dye or pigment so that it has a color tone that matches the coloration at each concentration when the test sample i-layer is immersed in a liquid to be tested at a specified concentration. The test reagent layer, the color tone layer, and the super absorbent area are formed by respectively applying an ink composition containing various test reagents, an ink composition for forming a gray tone layer, and an ink composition containing a super absorbent substance onto the base material. be able to. As a coating technique, a printing method, a coating method (for example, roll coating, spray coating, dip coating, solid coating), etc. can be used. Since it is preferable that the amount of the ink composition applied is relatively large and constant, it is preferable to apply the ink composition on the substrate by a silk screen printing method, an intaglio printing method, a gravure printing method, or the like. The amount applied varies depending on the type of ink composition, but is generally 2 to 150 g/button (
(when dry) is preferable. The base material is preferably one that does not react with the reagent composition and does not inhibit the coloring of the reagent, and specifically, for example, paper 0 synthetic paper, nonwoven fabric, synthetic resin film, or paper and synthetic resin film. A laminate etc. are used.
以下に図面によって本発明による検査用試験紙の具体例
を説明する。
第１図は、基材４上に例えばブドウ糖検出用検査試薬層
１を設け、検査試１層に接して検体中のブドウ′Ｉ！３
′ｆＡ度が０から所定の濃度に至る各濃度での検査試薬
層の呈色をそれぞれ示す判定基準用の色調層２ａ、２ｂ
、２ｃ、２ｄ、２ｅ、２ｆを貼付又は印刷によって設け
、検査試薬層１に隣接して高吸水性部３を設けてなる検
査用試験ｆ１５を示す。このような試験紙を用いて検査
を行えば、高吸水性部３が検査試薬層上の余分に付着し
た被検査液を吸収するので検査紙を引上げた際に試薬層
の下方に被検査液が流下滞留して呈色が不均一となるよ
うなことがなく、検体中の被検査物質濃度−の半定量を
正確に行うことができる。また、第２図及び第３図に示
すように基材４上に検査試薬層１と、該検査試薬層周囲
を囲むよう設けられた判定基準用の色調層２を設け、更
に、色調層２の周辺に間隔を置いて高吸水性部９又は３
．３′を設ける。本実施例において色調層２の色調を被
検査液中の被検査物質濃度が正常範囲である上限の濃度
であることを示すように設定すれば、検査用試験紙５を
検体中に浸漬することによって検体中の被検査物質の濃
度が正常範囲内にあるかどうかの判定が容易にでき、高
吸水性部を検査試薬層１色調層の周辺に設けたことによ
り、基材上に付着した余分な被検査液が流下進入するの
を防止することができ、被検査液の付着が均一となり、
正確な判定が可能となる。更に、第２，３図以外にも第
５図に示すように判定基準用の色調層を検査試薬１１を
挾むように２つに分割し、色調層２１，２ｊとし、更に
検査試薬層１と色調層２ｉ、２ｊを囲むように高吸水性
部３を設けることもでき、上記と同様の効果が得られる
。
第４図は、検体中の被検査物質の濃度が適正範囲内にあ
るかどうかを判定するためのものであって、例えば血糖
値の判定等に有効である。即ち、基材４上に検査試薬層
１を挾んで一方に適正範囲の下限値である濃度を示す色
調の色調層２ｑとζ適正範囲の上限値である濃度を示す
色調の色調層２ｈとよりなる判定基準用の色調層を設け
、更に検査試薬層１と色調層２０．２ｈを挾んで両側部
に間隔を置いて高吸水性部３．３′を設けたもので、検
査試薬層と色調層に付着した被検査液を、両側部から高
吸水層によって除ムしようとするものであって、血糖値
が適正な範囲内にあるかどうかの判定が正確にできる。
第６図は、基材４上に検査試薬層１と検体中の被検査物
質の濃度がそれぞれ所定の濃度であることを示す判定基
準用の色調層２に、２ Ｉ、２ｍ。
２ｎ、２０よりなる色調層２を検査試薬層と間隙を置い
て設け、色調層と検査試薬層の間に両層と直接接しない
ように高吸水性部３を設は検査試薬層と色調層に余分に
付着した被検査液を迅速に取り除くと共に、検査試薬等
が被検査液に試験紙を浸漬した際に溶出して色調層の呈
色を変化させるような不都合を完全に防止することがで
きる。
次に、本発明による検査用試験紙の詳細を実施例を挙げ
て説明する。
実施例１
検査試薬層製造
下記組成の検査試薬溶液を調製し、該検査試薬溶液を濾
紙（東洋濾紙製：Ｎｏ、５１）に含浸させ、５０℃で２
時間乾燥して検査試薬層を製造した。
検査試薬組成物
ブドウ糖酸化酵素（東洋防禦； Ｇｒａｄｅ ＩＩ ）
０．６重量部
ペルオキシダーゼ（東洋防禦； Ｇｒａｄｅ Ｉ［［）
０．１５Φ吊部
０−トリジンニ塩酸塩 ０．５重塁部
クエン酸／クエン酸ナトリウム緩衝液（ｐＨ５，５）８
０重量部
ゼラチン水溶液（５％）５０重９部
蒸溜水 ２０重量部エチ
ルアルコール ３０重１部色調層製
造
正常尿および正常尿にβ−Ｄ−グルコースを５０■／旧
、 １００１１ｇ／ｄ１． ２５０ｍｙ／旧、 ５
００ｙ／ｄｌ。
および２０００ｍｇ／ ｄ ｌの濃度になるようにそれ
ぞれ溶解したものを被検査液として用い、上記のように
して得られた検査試薬層を被検査液中に浸漬後直ちに取
出して１分間静置し、各検査試薬層の呈色を観察した。
下記組成物に分散染料を溶解／分散させ、濾紙（東洋濾
紙製；Ｎ１１５１）に含浸させ、５０℃で２時間乾燥さ
せることにより、色調層を製造した。各色調層の製造に
用いる分散染料の種類ならびに母は、下記組成物と分散
染料を濾紙に含浸して得られた色調層を被検査液に浸漬
後直ちに取出して１分間静置した場合の色調が上記検査
試薬層の呈色と一致するように設定した。
色調層組成物
ゼラチン水溶液（５％）５０ｍｍ部
蒸溜水 ２０ｍｍ部エチ
ルアルコール ３０重め部高吸水性
部製造
下記高吸水性組成物をホモミキサーで微細分散させた後
、第１図に示す基材４である厚さ３００μの白色ポリス
チレンシートに５ｇ ｘ ３０ｔｔｒｒｎの四角形とな
るようにスクリーン印刷した。用いたスクリーン版は１
５０メツシユ、レジスト及びスクリーン紗の厚さの合計
は８８μであった。
高吸水性組成物
高吸水性樹脂
（住友化学製：スミ力ゲル５Ｐ−５２０） １５０
ｍｍ部接着剤
（帝国インキ製；セリコール１３−００２メジウム）２
８０重量部
溶 剤
（帝国インキ製；セリコール１３−０００溶剤）７０ｍ
ｍ部
得られた印刷物を６０℃で１時間乾燥して高吸水性部を
得た。
検査用試験紙製造
上記の高吸水性部を形成した厚さ３００μの白色ポリス
チレンシートに、高吸水性部に近接して５ｍｍ Ｘ ３
０ｍｍの四角形に断裁した検査試薬層１を貼付し、検査
試薬層１に近接して上記のように調製して骨だ検体中の
β−Ｄ−グルコース濃度が０，５０／ｌＩｙ／ｄｌ、
１００η／ｄｌ、 ２５０７Ｉｇ／ｄ＋、 ５０
０１１ｇ／旧。
２０００ｍ９／旧であることを示す色調層２を一辺が５
ｍｍの四角形に断裁した２ａ、２ｂ、２ｃ、２ｄ、
、２ｅ、２ｆをそれぞれ貼付することにより、図１に
示す検査用試験紙５を製造した。
正常尿および正常尿にβ−Ｄ−グルコースを５０ｍｙ／
ｄｌ、 １ｏｏＩＲｆＩ、／ｌｊｌ、 ２５０ＩＲ
ｇ／ｄｌ、 ５００ｒＲｙ／ｄｌ。
および２０００１１ｇ／旧の濃度になるように溶解した
ものを被検査液として用い、得られた検査用試験紙５を
それぞれの被検査液に浸漬後直ちに取出して１分間静置
し、呈色を観察した。呈色は均一かつ鮮明であり、各被
検査液について、検査試薬層１の呈色と色調層２の該当
する被検査液濃度を示す２ａ、２ｂ、２ｃ、２ｄ、２ｅ
、２ｆの何れかの色調とは完全に一致した。
比較例１
検査用試験紙製造
実施例１に示した高吸水性部を設けない以外は、実施例
１と同様にして第１図に示した検査用試験紙５を製造し
た。
実施例１と同様にしてＦＡ製したβ−Ｄ−グルコースを
含む被検査液を用い、得られた検査用試験紙をそれぞれ
の被検査液に浸漬後直ちに取出して１分間静置し、呈色
を観察した。
検査試薬層及び色調層に付着した過剰の被検査液の影響
で、検査試薬層の一部で呈色阻害が起り、呈色は不均一
かつ不鮮明となり、各被検査液について、検査試薬層の
呈色と該当する被検査液濃度を示す色調層の色調とは一
致しなかった。
実施例２
高吸水性樹脂造
第２図に示す基材４である厚さ３００μの白色ポリスチ
レンシートに、相互の間隔が１８ｍＩｎである２つの２
闇Ｘ ２０ｍ１の長四角形となるように高吸水性部３，
３′をスクリーン印刷する以外は、実施例１と同様にし
て高吸水性部を得た。
検査試薬層製造
下記組成の検査試薬組成物をホモミキサーで微細分散さ
せた後、スクリーン印刷により、上記の高吸水性部を形
成した厚さ３００μの白色ポリスチレンシートの２つの
高吸水性部の中間に、５ｍＩｎ×５Ｍの四角形となるよ
うに印刷して検査試薬層１とした。用いたスクリーン版
は８０メツシユ、レジスト及びスクリーン紗の厚さの合
計は１３０μであった。
検査試薬組成物
ブドウ”糖酸化酵素（東洋防禦： Ｇｒａｄｅ ＩＩ
）３．６ｍｍ部
ペルオキシダーゼ（東洋防禦； Ｇｒａｄｅ ｍ ＞２
．４重量部
グアヤク脂 ４．８ｍｍ部ソル
ビタンモノラウレート
（花王石鹸製；スパン２０ ） ７．２重
吊部Ｌ−アスコルビルステアレート ０．２４重量
部クエンｖｔ２．８重量部
クエン酸ナトリウム １１．０重ω部ポ
リビニルピロリドン
（ＢＡＳＦ製：コリトン９０） １２．
６重量部ポリビニルブチラール
（積水化学製；エスレックＢＸ−１） ２．２５ｍ
ｍ部セルロース微粉末
（旭化成￥Ｊ：アビセルＳＦ） １７１重
量部ｎ−アミルアルコール ２２８重量部
ブチルセロソルブアセテート ３３．５ｍｍ部得
られた印刷物を６０℃で４０分間乾燥して第２図に示す
検査試薬層１を得た。
色調層製造 び検査用試験紙製造
正常尿にβ−Ｄ−グルコースを５０１Ｒｙ／ｄｌの濃度
になるように溶解したものを被検査液として用い、上記
のようにして得られた検査試薬層を被検査液中に浸漬後
直ちに取出して１分間静置し、検査試薬層の呈色を観察
した。
次いで油溶性染料の種類ならびに是を、得られた色調層
を被検査液に浸漬後直ちに取出して １分間静置した場
合の色調が、上記検査試薬層１の呈色と一致するように
設定し、色調層２を得た。即ち、ホモミキサーで微細分
散させた下記色調層組成物に油溶性染料を溶解／分散さ
せた後、検体中のβ−Ｄ−グルコース濃度が５０ｆｎ９
／旧であることを示す色調層２を、中央に一辺が５ｍｍ
の四角形の切欠きを有する一辺が１５ ｍ＃Ｉの四角形
となるように上記の高吸水性部３，３′及び検査試薬層
１を形成した厚さ３００μの白色ポリスチレンシートに
検 。
査試薬層１に近接してスクリーン印刷し、得られた印刷
物を６０℃で４０分間乾燥して形成することにより、図
２に示す検査用試験紙５を製造した。用いたスクリーン
版は８０メツシユ、レジスト及びスクリーン紗の厚さの
合計は１３０μであった。
色調層組成物
ソルビタンモノラウレート
（花王石鹸製；スパン２０）７゜２１吊部ポリビニルピ
ロリドン
（ＢＡＳＦ製；コリトン９０．） １２
．６重量部ポリビニルブチラール
（積水化学製：エスレックＢＸ−１） ２．２５
ｒ＝ａ部セルロース微粉末
（脂化成製：アピセルＳＦ） １７１ｆｆ
ｉｆｆｉ部ｎ−アミルアルコール ２２８
重量部ブチルセロソルブアセテート ３３．５ｍ
ｍ部正常尿及び正常尿にβ−Ｄ−グルコースを５０１１
１Ｊ／旧、 １００１１１ｇ／ｄ＋の濃度になるよう
に溶解したものを被検査液として用い、得られた検査用
試験紙をそれぞれの被検査液に浸漬後直ちに取出して１
分間静置し、呈色を観察した。呈色は均一かつ鮮明であ
り、被検査液のβ−Ｄ−グルコース濃度が５０１１９７
旧の場合には、検査試薬層の呈色と色調層の色調とは完
全に一致した。被検査液が正常尿の場合或いは被検査液
のβ−Ｄ−グルコース濃度が１００ｍｇ／旧の場合には
、検査試薬層の呈色と色調層の色調とは明確に区別出来
た。
比較例２
検査用試験紙製造
実施例２に示した高吸水性部を紐けない以外は、実施例
２と同様にして、図２に示した検査用試験 紙を製造
した。
実施例２と同様にして調製したβ−Ｄ−グルコース５０
Ｑ／旧を含む被検査液を用い、得られた検査試験紙を被
検査液中に浸漬後直ちに取出して１分間静置し、呈色を
観察した。被検査液のβ−Ｄ−グルコース濃度が５０ｒ
ｎｙ／旧の場合、検査試薬層及び色調層に付着した過剰
の被検査液の影響で、検査試薬層の一部で呈色阻害が起
り、呈色は不均一かつ不鮮明となり、検査試薬層の呈色
と色調層の色調とは一致しなかった。
実施例３
高吸水性部製造
第５図に示す基材４である厚さ３００μの白色ポリスチ
レンシートに、中央に１５ｍｙ＋ ｘ １５ｍｔｒの四
角形の切欠きを有する１７ｒｎｔｒ ｘ １７ｍｍの四
角形となるようにスクリーン印刷する以外は、実施例１
と同様にして高吸水性部３を得た。
検査試薬層￥Ｊ造
下記組成の検査試薬組成物をホモミキサーで微細分散さ
せた後、スクリーン印刷法により、上記の高吸水性部３
を形成した厚さ３００μの白色ポリスチレンシートの高
吸水性部の中央に、高吸水性部に近接して５ｍｍＸ１５
ｍｍの四角形となるように検査試薬層１を印刷した。用
いたスクリーン版は８０メツシユ、レジスト及びスクリ
ーン紗の厚さの合計は１９０μであった。
検査試薬組成物
テトラブロムフェノールブルー ０．４０ ｍｍ部ク
エン酸 ２５．７重量部クエ
ン酸ナトリウム １１．０重足部ソルビ
タンモノラウレート
（花王石鹸製；スパン２０） ４．０重量
部カルボキシメチルセルロースナト
リウム
（ワットマン製： ＣＭ−３２ ） ５０．
０中量部カルボキシメチルセルロース
カルシウム塩（ダイセル化学製） １０．０ｍｍ部
メチルビニルエーテル／無水マレイ
ン酸共重合体（Ｇ．八．Ｆ社製；ガントレッツ＾Ｎ−１
６９）のアミルアルコールエステル化物
４．９７ ｆｆｉ吊部上部セルロース微
粉脂化成製：アビセルＳＦ） １０８中吊
部ｎ−アミルアルコール ２８．１ｆｆ！
役部ブチルセロソルブ １０７． ７ｍ
ｍ部ブチルセロソルブアセテート ５０．２ｍｍ
部青られた印刷物を６０℃で３０分間乾燥して第５図に
示す検査試薬層１を得た。
色調層製造及び検査用試験紙製造
正常尿に牛血清アルブミンを１５＃Ｉｇ／ｄ＋の濃度に
なるように溶解したものを被検査液として用い、上記の
ようにして得られた検査試薬層を被検査液中に浸漬後直
ちに取出して１分間静置し、検査試薬層の呈色を観察し
た。
ホモミキサーで微細分散させた下記色調層組成物に油溶
は染料を溶解／分散させた後、５！ＲｎＸ１５闇の２つ
の四角形２ｉ．２ｊとなるように基材３上に上記のよう
にして設けられた高吸水性部３ならびに検査試薬層１に
近接してスクリーン印刷し、得られた印刷物を６０℃で
３０分間乾燥することにより、第５図に示す検査用試験
紙５を製造した。用いたスクリーン版は８０メツシユ、
レジスト及びスクリーン紗の厚さの合計は１９０μであ
った。油溶性染料の種類ならびに吊は、得られた色調層
を被検査液に浸漬後直ちに取出して１分間静置した場合
の色調が、上記検査試薬層の呈色と一致するように設定
した。
色調層組成物
ソルビタンモノラウレート ４．０重量部メ
チルビニルエーテル／Ｂ水マレイ
ン酸共重合体（Ｇ．＾．Ｆ社製：ガントレッツＡＮー１
６９＞のアミルアルコールエステル化物
４、９７ｍｍ部セルロース微粉末
（脂化成製；アビセルＳＦ） １０８中吊
部ｎーアミルアルコール ２８．１市ａ部
ブチルセロソルブ １０７． ７ｍｍ部
ブチルセロソルブアセテート ５０．２ｍｍ部正
常尿および正常尿に牛血清アルブミンを１５ｍｙ／ｄｉ
及び３０１Ｑ／ｄｌの濃度になるように溶解したものを
被検査液として用い、得られた検査用試験紙を浸漬後直
ちに取出して１分間静置し、呈色を観察した。
呈色は均一かつ鮮明であり、被検査液の牛血清アルブミ
ン濃度ｉ５ｙ／旧の場合には、検査試薬層１の呈色と色
調層２ｉ，２ｊの色調とは完全に一致した。被検査液が
正常尿の場合或いは被検査液の牛血清アルブミン濃度が
３０７１ｇ／ｄｌの場合には、検査試薬層１の呈色と色
調層２ｉ、２ｊの色調とは明確に区別出来た。
比較例３
検査用試験紙製造
実施例３に示した高吸水性部を設けない以外は、実施例
３と同様にして、第５図に示した検査用試験紙を製造し
た。
実施例３と同様にして調製した被検査液を用い、臂られ
た検査用試験紙を浸漬後直ちに取出して１分間静置し、
呈色を観察した。被検査液の牛面清アルブミン濃度が１
５１１１４Ｆ／旧の場合、検査試薬層１及び色調層２に
付着した過剰の被検査液の影きで、検査試薬層の一部で
呈色阻害が起り、呈色は不均一かつ不鮮明となり、検査
試薬層の呈色と色調Ｎの色調とは一致しなかった。
実施例４
高吸水性部製造
第６図に示す基材４である厚さ３００μの白色ポリスチ
レンシートに２ｒＭｎＸ２５ｓの四角形となるようにス
クリーン印刷する以外は、実施例１と同機にして高吸水
性部３を得た。
撒五ｍ艮１
下記試薬組成物をホモミキサーで溶解分散させた後、水
酸化ナトリウム０．０９８重量部を水２重位部に溶解し
たものを添加し、ホモミキサーで充分溶解分散させるこ
とにより検査試薬組成物を調製した。
検査試薬組成物
メチルレッド ０．０７０重量部ブ
ロムチモールブルー １．０重量部ドデ
シルトリメチルアンモニウムクロライド・１．０重量部
ポリビニルピロリドン（ＢＡＳＦ製；コリトン９０）１
３．２重量部
ポリビニルブチラール
（積水化学製；エスレックＢＸ−１）’ １．５４重
０部セルロース微粉末（脂化成製；アビセル５Ｆ）１７
４重吊重
争チルセロソルブ ２５７重是置台ら
れた検査試薬組成物を、スクリーン印刷により、上記の
高吸水性部を形成した厚さ３００μの白色ポリスチレン
シートの高吸水性部から１．５闇の間隔で、高吸水性部
と平行に５１１ｘ２５ＩＩＩ＃Ｉの四角形となるように
印刷した。用いたスクリーン版は８０メツシユ、レジス
ト及びスクリーン紗の厚さの合計は１９０μであった。
得られた印刷物を６０℃で３０分間乾燥して第６図に示
す検査試薬層１を得た。
色調層製造及び検査用試験紙製造
正常尿の１１８を塩酸或いは水酸化ナトリウムを用いて
、ｐＨ５，６，７，８及び９にそれぞれ調節したものを
被検査液として用い、検査試薬層を浸漬後直ちに取出し
て１分間静置し、呈色を観察した。
ホモミキサーで微細分散させた下記色１ｉ１１層組成物
に分散染料を溶解／分散させた後、被検査液のＩｌｌが
５．６．７．８．９であることを示す色調層２を構成す
る一辺が５ｍの四角形２に、２１．２ｍ、 ２ｎ、２０
となるように基材４上に上記のようにして設けられた高
吸水性部から１．５ｍｍの間隔で、高吸水性部と平行に
スクリーン印刷し、得られた印刷物を６０℃で３０分間
乾燥することにより、第６図に示す検査用試験紙５を製
造した。用いたスクリーン版は８０メツシユ、レジスト
およびスクリーン紗の厚さの合計は１９０μであった。
分散染料の種類ならびに吊は、得られた色調層を被検査
液に浸漬後直ちに取出して１分間静置した場合の色調が
、上記呈色と一致するように設定した。
色調層組成物
ポリビニルピロリドン（ＢＡＳｒｌ：コリトン９０）１
３．２１吊部
ポリビニルブチラール
（積水化学製；エスレック８Ｘ−１） １．５４重
凸部セルロース微粉末（脂化成製；アビセル５Ｆ）１７
４重吊重
争チルセロソルブ ２５７重量部正常
尿のＩＩＨをＦＡ酸或いは水酸化すトリウムを用いて、
ｐＨ５，６，７，８及び９にそれぞれ調節したものを被
検査液として用い、得られた検査用試験紙５を浸漬後直
ちに取出して１分間静置し、呈色を観察した。呈色は均
一かつ鮮明であり、各被検査液について、検査試薬層１
の呈色と色調層２の該当する被検査液ｐＨを示す２に、
２１．２ｍ。
２ｎ、２０の何れかの色調とは完全に一致した。
比較例４
検査用試験紙製造
実施例４に示した高吸水性部を設けない以外は、実施例
４と同様にして図６に示した検査用試験紙を製造した。
実施例４と同様にして調製した被検査液を用い、得られ
た検査試薬層を浸漬後直ちに取出して１分間静置し、呈
色を観察した。
検査試薬層に付着した過剰の被検査液の影響で、検査試
薬層の一部で呈色阻害が起り、呈色は不均一かつ不鮮明
となり、各被検査液について、検査試薬層の２色と該当
する被検査液′ｊ３度を示す色調層の色調とは一致しな
かった。
Ｋ発明の効果１
本発明は、検査用試験紙の基材表面に、被検査液中の検
査目的物質の含有量に応じて色調変化をする検査試薬を
含む試薬層と、該検査試薬層に含まれる検査試薬主要成
分以外の検査試薬層構成材料を実質的に含み、染料等に
よって着色された被検査液中の検査目的物質の含有量を
示す判定基準用の色調層とを設け、かつ検査試薬層と色
調層の近傍に高吸水性部を設けて、色調層を構成する材
料を検査試薬層の構成材料と可能な限り同じにし、被検
査液による濡れを均一にすると共に高吸水性部を設けた
ことによって過剰量の被検査液の付着に起因する検査試
薬層の呈色阻害、ならびに呈色斑１着色層に生ずる色調
斑を防止して、均一な呈色が得られるようにしたので被
検査液中の検査目的物質の含有量をきわめて正確に判定
できる。
また、本発明による検査用試験紙は、図面に示すような
構成であるので被検査液中に浸漬するのみで、誰でも容
易に被検査液中の検査物質濃度が正常な範囲にあるかど
うかを判定し、判定に基いて病院や検査機関での精密検
査が必要かどうかを判断できるので、病気の発見、治療
に極めて有用である。Specific examples of the test strip according to the present invention will be explained below with reference to the drawings. In FIG. 1, for example, a test reagent layer 1 for detecting glucose is provided on a base material 4, and the test reagent layer 1 for detecting glucose is placed in contact with the test reagent layer 1, and the grape 'I' in the sample is removed. 3
Judgment standard color tone layers 2a and 2b each showing the coloration of the test reagent layer at each concentration from 0 to a predetermined concentration.
, 2c, 2d, 2e, and 2f are provided by pasting or printing, and a highly water-absorbing portion 3 is provided adjacent to the test reagent layer 1. If a test is performed using such a test paper, the superabsorbent portion 3 absorbs the excess test liquid on the test reagent layer, so when the test paper is pulled up, the test liquid will be deposited below the reagent layer. It is possible to accurately semi-quantitate the concentration of the test substance in the specimen, without causing non-uniform coloration due to flow down and stagnation. Further, as shown in FIGS. 2 and 3, a test reagent layer 1 and a color tone layer 2 for judgment criteria provided surrounding the test reagent layer are provided on the base material 4, and furthermore, a color tone layer 2 is provided on the base material 4. super absorbent parts 9 or 3 at intervals around the periphery of
．． 3' is provided. In this embodiment, if the color tone of the color tone layer 2 is set to indicate that the concentration of the test substance in the test liquid is at the upper limit of the normal range, the test strip 5 can be immersed in the sample. This makes it easy to determine whether the concentration of the test substance in the sample is within the normal range, and by providing a highly water-absorbing area around the color tone layer of the test reagent layer 1, it is possible to easily determine whether the concentration of the test substance in the sample is within the normal range. It is possible to prevent the liquid to be tested from flowing down, and the adhesion of the liquid to be tested is uniform.
Accurate judgment becomes possible. Furthermore, in addition to FIGS. 2 and 3, as shown in FIG. It is also possible to provide the highly absorbent portion 3 so as to surround the layers 2i and 2j, and the same effect as described above can be obtained. FIG. 4 is for determining whether the concentration of a test substance in a specimen is within an appropriate range, and is effective for determining, for example, blood sugar level. That is, the test reagent layer 1 is sandwiched on the base material 4, and on one side there is a tone layer 2q with a color tone showing a density that is the lower limit of the appropriate range, and a tone layer 2h with a color tone showing a density that is the upper limit of the ζ proper range. A color tone layer for judgment criteria is provided, and super absorbent areas 3.3' are provided at intervals on both sides sandwiching the test reagent layer 1 and the color tone layer 20.2h. The superabsorbent layer attempts to remove the liquid to be tested adhering to the layer from both sides, making it possible to accurately determine whether the blood sugar level is within an appropriate range. FIG. 6 shows a test reagent layer 1 on a base material 4 and a color tone layer 2 for judgment criteria indicating that the concentration of the test substance in the specimen is a predetermined concentration, respectively, with 2 I and 2 m. A color tone layer 2 consisting of 2n and 20 is provided with a gap between the test reagent layer and the test reagent layer, and a highly water-absorbing part 3 is provided between the color tone layer and the test reagent layer so as not to be in direct contact with both layers. In addition to quickly removing excess test liquid adhering to the test liquid, it is possible to completely prevent inconveniences such as test reagents, etc. eluting when the test paper is immersed in the test liquid and changing the coloration of the color tone layer. can. Next, details of the test strip for testing according to the present invention will be explained with reference to examples. Example 1 Manufacture of test reagent layer A test reagent solution having the following composition was prepared, and a filter paper (manufactured by Toyo Roshi Co., Ltd.: No. 51) was impregnated with the test reagent solution.
A test reagent layer was prepared by drying for a period of time. Test reagent composition Glucose oxidase (Toyo Defense; Grade II)
0.6 parts by weight peroxidase (Toyo Defense; Grade I [[)
0.15Φ hanging part 0-toridine dihydrochloride 0.5 double part Citric acid/sodium citrate buffer (pH 5,5) 8
0 parts by weight Gelatin aqueous solution (5%) 50 parts by weight 9 parts Distilled water 20 parts by weight Ethyl alcohol 30 parts by weight Color tone layer production Normal urine and β-D-glucose in normal urine 50 μ/old, 10011 g/d1. 250my/old, 5
00y/dl. and 2000 mg/dl respectively dissolved to a concentration of 2,000 mg/dl were used as the test liquid, and the test reagent layer obtained as above was immersed in the test liquid, immediately taken out and left to stand for 1 minute. The color development of each test reagent layer was observed. A color tone layer was produced by dissolving/dispersing a disperse dye in the following composition, impregnating a filter paper (manufactured by Toyo Roshi Co., Ltd.; N1151), and drying at 50° C. for 2 hours. The type and base of the disperse dye used in the production of each color tone layer are the color tone obtained when the color tone layer obtained by impregnating a filter paper with the following composition and disperse dye is taken out immediately after being immersed in the test liquid and left to stand for 1 minute. was set to match the coloration of the test reagent layer. Color tone layer composition Gelatin aqueous solution (5%) 50 mm parts Distilled water 20 mm parts Ethyl alcohol 30 heavy parts Super absorbent part Manufacture After finely dispersing the following super absorbent composition in a homomixer, the base material shown in Figure 1 was prepared. Screen printing was performed on a white polystyrene sheet having a thickness of 300 μm (No. 4) so as to form a rectangle of 5 g x 30 ttrrn. The screen version used is 1
The total thickness of the resist and screen gauze was 88μ. Super absorbent composition Super absorbent resin (Sumitomo Chemical: Sumiriki Gel 5P-520) 150
mm part adhesive (manufactured by Teikoku Ink; Sericol 13-002 medium) 2
80 parts by weight of solvent (manufactured by Teikoku Ink; Sericol 13-000 solvent) 70 m
m parts of the obtained printed matter were dried at 60° C. for 1 hour to obtain a highly water-absorbent part. Manufacture of test paper for inspection: On the white polystyrene sheet with a thickness of 300μ on which the above-mentioned highly water-absorbent part was formed, a 5 mm
The test reagent layer 1 cut into a 0 mm square is pasted and prepared as described above in the vicinity of the test reagent layer 1, so that the β-D-glucose concentration in the bone specimen is 0.50/lIy/dl,
100η/dl, 2507Ig/d+, 50
011g/old. 2,000 m9/1 side of color tone layer 2 indicating that it is old is 5
2a, 2b, 2c, 2d cut into mm squares,
, 2e, and 2f, the test paper 5 shown in FIG. 1 was manufactured. β-D-glucose in normal urine and normal urine 50my/
dl, 1ooIRfI, /ljl, 250IR
g/dl, 500rRy/dl. and 200,011 g/old dissolved to a concentration of 200,011 g/old were used as test liquids, and the obtained test paper 5 was immersed in each test liquid, immediately taken out, left to stand for 1 minute, and observed for color development. did. The coloration is uniform and clear, and for each test liquid, 2a, 2b, 2c, 2d, and 2e indicate the coloration of the test reagent layer 1 and the concentration of the test liquid in the color tone layer 2.
, 2f completely matched the color tone. Comparative Example 1 Manufacture of Test Paper for Inspection Test test paper 5 for inspection shown in FIG. 1 was produced in the same manner as in Example 1 except that the highly water-absorbent portion shown in Example 1 was not provided. Using test liquids containing β-D-glucose prepared by FA in the same manner as in Example 1, the obtained test strips were immersed in each test liquid, immediately taken out and left to stand for 1 minute to determine color. observed. Due to the influence of excess test liquid adhering to the test reagent layer and color tone layer, color development is inhibited in a part of the test reagent layer, and the color development becomes uneven and unclear. The coloration did not match the color tone of the color tone layer indicating the concentration of the test liquid. Example 2 Made of super absorbent resin A white polystyrene sheet with a thickness of 300 μm, which is the base material 4 shown in FIG.
Highly absorbent part 3, so that it becomes a rectangle of darkness
A highly water-absorbent part was obtained in the same manner as in Example 1 except that 3' was screen printed. Manufacture of test reagent layer After finely dispersing the test reagent composition with the following composition in a homomixer, screen printing was performed to form the above-mentioned super absorbent part. A test reagent layer 1 was prepared by printing a 5 mIn x 5M rectangle. The screen plate used had 80 meshes, and the total thickness of the resist and screen gauze was 130 μm. Test reagent composition “Grape” sugar oxidase (Toyo Boken: Grade II
) 3.6mm part peroxidase (Toyo Defense; Grade m >2
．． 4 parts by weight Guaiac butter 4.8 mm parts Sorbitan monolaurate (manufactured by Kao Soap; Span 20) 7.2 parts by weight L-ascorbyl stearate 0.24 parts by weight Citric acid vt 2.8 parts by weight Sodium citrate 11.0 parts by weight ω-part polyvinylpyrrolidone (manufactured by BASF: Koliton 90) 12.
6 parts by weight polyvinyl butyral (Sekisui Chemical; S-LEC BX-1) 2.25m
m parts Cellulose fine powder (Asahi Kasei J: Avicel SF) 171 parts by weight n-amyl alcohol 228 parts by weight Butyl cellosolve acetate 33.5 mm parts The obtained printed matter was dried at 60°C for 40 minutes to form the test reagent layer shown in FIG. I got 1. Production of color tone layer and production of test paper for testing Using β-D-glucose dissolved in normal urine to a concentration of 501 Ry/dl as the test liquid, the test reagent layer obtained as described above was coated. Immediately after being immersed in the test solution, it was taken out and allowed to stand for 1 minute, and the color development of the test reagent layer was observed. Next, the type and quality of the oil-soluble dye were set so that the color tone obtained when the obtained color tone layer was immersed in the test liquid and immediately taken out and left to stand for 1 minute matched the coloration of the test reagent layer 1. , tone layer 2 was obtained. That is, after dissolving/dispersing an oil-soluble dye in the following color tone layer composition finely dispersed with a homomixer, the β-D-glucose concentration in the specimen was 50fn9.
/ Color tone layer 2 indicating that it is old, 5 mm on each side in the center
The test was carried out on a white polystyrene sheet with a thickness of 300μ, on which the above-mentioned super absorbent parts 3 and 3' and the test reagent layer 1 were formed so as to form a rectangle with a square cutout of 15 m#I on each side. The test paper 5 shown in FIG. 2 was manufactured by screen printing in the vicinity of the test reagent layer 1 and drying the resulting print at 60° C. for 40 minutes. The screen plate used had 80 meshes, and the total thickness of the resist and screen gauze was 130 μm. Color tone layer composition Sorbitan monolaurate (manufactured by Kao Soap; Span 20) 7°21 Hanging part polyvinylpyrrolidone (manufactured by BASF; Koliton 90.) 12
．． 6 parts by weight polyvinyl butyral (Sekisui Chemical: S-LEC BX-1) 2.25
r=a part Cellulose fine powder (Fushikasei: Apicel SF) 171ff
iffi part n-amyl alcohol 228
Weight part Butyl cellosolve acetate 33.5m
5011 β-D-glucose in normal urine and normal urine
1J/Old, use a solution dissolved to a concentration of 100111 g/d+ as the test liquid, and immediately take out the obtained test paper after immersing it in each test liquid.
The mixture was allowed to stand for a minute and the color development was observed. The coloration is uniform and clear, and the β-D-glucose concentration of the test liquid is 501197.
In the old case, the coloration of the test reagent layer and the color tone of the tone layer completely matched. When the test liquid was normal urine or when the β-D-glucose concentration of the test liquid was 100 mg/old, the color of the test reagent layer and the color tone of the color tone layer could be clearly distinguished. Comparative Example 2 Manufacture of Test Paper for Testing The test paper for testing shown in FIG. 2 was produced in the same manner as in Example 2, except that the highly water-absorbent portion shown in Example 2 was not tied. β-D-glucose 50 prepared in the same manner as in Example 2
Using a liquid to be tested containing Q/Old, the resulting test paper was immersed in the liquid to be tested, immediately taken out, allowed to stand for 1 minute, and observed for color development. β-D-glucose concentration of test liquid is 50r
In the case of ny/old, due to the influence of excess test liquid adhering to the test reagent layer and color tone layer, color development is inhibited in a part of the test reagent layer, and the color development becomes uneven and unclear, and the test reagent layer The coloration and the tone of the tone layer did not match. Example 3 Production of super absorbent part A white polystyrene sheet with a thickness of 300μ, which is the base material 4 shown in FIG. Example 1 except that
A super absorbent part 3 was obtained in the same manner as above. Test reagent layer￥J-made After finely dispersing the test reagent composition with the following composition using a homomixer, the above-mentioned super absorbent portion 3 is formed by screen printing.
In the center of the highly water-absorbent part of the white polystyrene sheet with a thickness of 300μ, a 5mm x 15
The test reagent layer 1 was printed to form a square of mm. The screen plate used had 80 meshes, and the total thickness of the resist and screen gauze was 190 μm. Test reagent composition Tetrabromophenol blue 0.40 mm part Citric acid 25.7 parts by weight Sodium citrate 11.0 parts by weight Sorbitan monolaurate (Kao Soap; Span 20) 4.0 parts by weight Sodium carboxymethyl cellulose ( Manufactured by Whatman: CM-32) 50.
0 parts by weight Carboxymethylcellulose calcium salt (manufactured by Daicel Chemical) 10.0 mm parts Methyl vinyl ether/maleic anhydride copolymer (manufactured by G.8.F Company; Gauntlets ^N-1
Amyl alcohol ester of 69)
4.97 ffi hanging part upper part Cellulose Fine Powder Chemicals: Avicel SF) 108 Middle hanging part n-amyl alcohol 28.1ff!
Yakubu Butyl Cellosolve 107. 7m
m part butyl cellosolve acetate 50.2mm
The dyed printed matter was dried at 60° C. for 30 minutes to obtain the test reagent layer 1 shown in FIG. Manufacture of color tone layer and test paper manufacturing Using normal urine dissolved with bovine serum albumin at a concentration of 15#Ig/d+, the test reagent layer obtained as described above was coated. Immediately after being immersed in the test solution, it was taken out and allowed to stand for 1 minute, and the color development of the test reagent layer was observed. After dissolving/dispersing the oil-soluble dye in the following color tone layer composition finely dispersed with a homomixer, 5! RnX15 Two Squares of Darkness 2i. 2j by screen printing in close proximity to the super absorbent part 3 and the test reagent layer 1 provided on the base material 3 as described above, and drying the obtained printed matter at 60 ° C. for 30 minutes. , an inspection test paper 5 shown in FIG. 5 was manufactured. The screen version used was 80 meshes,
The total thickness of the resist and screen gauze was 190μ. The type and length of the oil-soluble dye were set so that the color tone obtained when the obtained color tone layer was immersed in the test liquid and immediately taken out and left to stand for 1 minute matched the coloration of the test reagent layer. Tone layer composition Sorbitan monolaurate 4.0 parts by weight Methyl vinyl ether/B water maleic acid copolymer (manufactured by G.^.F: Gantrez AN-1
Amyl alcohol ester of 69>
4. 97 mm part Cellulose fine powder (manufactured by Fukkasei; Avicel SF) 108 Middle hanging part n - amyl alcohol 28.1 City a part Butyl cellosolve 107. 7mm part butyl cellosolve acetate 50.2mm part normal urine and normal urine with bovine serum albumin 15my/di
A solution dissolved to a concentration of 301Q/dl was used as the liquid to be tested, and the resulting test paper was taken out immediately after immersion, left to stand for 1 minute, and color development was observed. The color development was uniform and clear, and when the bovine serum albumin concentration of the test liquid was i5y/old, the color development of the test reagent layer 1 and the color tone of the color tone layers 2i and 2j completely matched. When the test liquid was normal urine or when the bovine serum albumin concentration of the test liquid was 3071 g/dl, the color of the test reagent layer 1 and the color tone of the color tone layers 2i and 2j could be clearly distinguished. Comparative Example 3 Manufacture of Test Paper for Testing The test paper for testing shown in FIG. 5 was produced in the same manner as in Example 3, except that the highly water-absorbent portion shown in Example 3 was not provided. Using the test liquid prepared in the same manner as in Example 3, the test strip was immersed and immediately taken out and allowed to stand for 1 minute.
Color development was observed. The concentration of bovine serum albumin in the test liquid is 1.
In the case of 51114F/old, the shadow of excess test liquid adhering to the test reagent layer 1 and color tone layer 2 inhibits color development in a part of the test reagent layer, making the color uneven and unclear, making the test difficult. The coloration of the reagent layer and the color tone N did not match. Example 4 Manufacture of super absorbent part A super absorbent part was produced using the same machine as in Example 1, except that a 300μ thick white polystyrene sheet, which is the base material 4 shown in FIG. I got 3. After dissolving and dispersing the following reagent composition with a homomixer, add 0.098 parts by weight of sodium hydroxide dissolved in two parts of water, and thoroughly dissolve and disperse with a homomixer. A test reagent composition was prepared. Test reagent composition Methyl red 0.070 parts by weight Bromthymol blue 1.0 parts by weight Dodecyltrimethylammonium chloride 1.0 parts by weight Polyvinylpyrrolidone (manufactured by BASF; Koliton 90) 1
3.2 parts by weight Polyvinyl butyral (manufactured by Sekisui Chemical; S-LEC BX-1)' 1.54 parts by weight 0 parts Cellulose fine powder (manufactured by Fukai Kasei; Avicel 5F) 17
The test reagent composition placed on the 257-layer suspension table was screen printed on a 1.5-layer suspension from the highly water-absorbent part of the 300-μ thick white polystyrene sheet on which the above-mentioned highly water-absorbent part had been formed. It was printed parallel to the super absorbent area at intervals to form a 511 x 25 III #I rectangle. The screen plate used had 80 meshes, and the total thickness of the resist and screen gauze was 190 μm. The obtained printed matter was dried at 60° C. for 30 minutes to obtain the test reagent layer 1 shown in FIG. Production of color tone layer and production of test strips Normal urine 118 was adjusted to pH 5, 6, 7, 8, and 9 using hydrochloric acid or sodium hydroxide, respectively, as the test liquid, and the test reagent layer was immersed. It was immediately taken out and allowed to stand for 1 minute, and the color development was observed. After dissolving/dispersing the disperse dye in the following color 1i11 layer composition finely dispersed with a homomixer, form tone layer 2 showing that Ill of the test liquid is 5.6.7.8.9. 21.2m, 2n, 20 to square 2 with side 5m
Screen printing was performed in parallel to the highly absorbent area at intervals of 1.5 mm from the highly absorbent area provided on the base material 4 as described above so that the resulting print was heated at 60°C for 30 minutes By drying, test paper 5 for inspection shown in FIG. 6 was manufactured. The screen plate used had 80 meshes, and the total thickness of the resist and screen gauze was 190 μm. The type and suspension of the disperse dye were set so that the color tone obtained when the obtained color tone layer was immersed in the test liquid and immediately taken out and left to stand for 1 minute matched the color development described above. Tone layer composition polyvinylpyrrolidone (BASrl: Koliton 90) 1
3.21 Hanging part polyvinyl butyral (Sekisui Chemical; S-LEC 8X-1) 1.54 Double convex part Cellulose fine powder (Fushikasei; Avicel 5F) 17
257 parts by weight of 4-fold suspension thircellosolve normal urine IIH using FA acid or thorium hydroxide,
The liquids adjusted to pH 5, 6, 7, 8, and 9 were used as test liquids, and the resulting test paper 5 was taken out immediately after immersion, left to stand for 1 minute, and color development was observed. The coloration is uniform and clear, and for each test liquid, the test reagent layer 1
2 shows the coloration and the pH of the test liquid corresponding to the color tone layer 2,
21.2m. The color tone completely matched with either 2n or 20. Comparative Example 4 Manufacture of Test Paper for Testing The test paper for testing shown in FIG. 6 was produced in the same manner as in Example 4, except that the highly water-absorbent portion shown in Example 4 was not provided. Using a test liquid prepared in the same manner as in Example 4, the test reagent layer obtained was immediately taken out after immersion, left to stand for 1 minute, and color development was observed. Due to the influence of the excess test liquid adhering to the test reagent layer, color development is inhibited in a part of the test reagent layer, and the color development becomes uneven and unclear. The color tone did not match the color tone of the color tone layer showing 3 degrees of the corresponding liquid to be tested. K Effect of the Invention 1 The present invention provides a reagent layer containing a test reagent that changes color tone depending on the content of the substance to be tested in the liquid to be tested, on the surface of the base material of the test strip for testing, and A color tone layer for determining the content of the substance to be tested in the liquid to be tested, which substantially contains the test reagent layer constituent materials other than the main components of the test reagent contained therein, and is colored with dye etc. A highly water-absorbing part is provided near the reagent layer and color tone layer, and the material constituting the color tone layer is made as similar as possible to the material constituting the test reagent layer, so that wetting by the test liquid is uniform and the highly water-absorbing part By providing this, it is possible to prevent coloration inhibition of the test reagent layer due to adhesion of an excessive amount of the test liquid, as well as coloration unevenness that occurs in the colored layer 1, thereby making it possible to obtain uniform coloration. Therefore, the content of the substance to be tested in the liquid to be tested can be determined extremely accurately. In addition, since the test strip according to the present invention has the configuration shown in the drawing, anyone can easily check whether the concentration of the test substance in the test liquid is within the normal range by simply immersing it in the test liquid. It is extremely useful for the detection and treatment of diseases, as it can determine whether a detailed examination at a hospital or laboratory is necessary based on the determination.
第１図乃至第６図は、本発明による検査用試験紙の実施
例を示す概略平面図である。
１・・・検査試薬層、 ２・・・色調層。
３・・・高吸水性部、 ４・・・基材。
５・・・検査用試験紙FIGS. 1 to 6 are schematic plan views showing embodiments of test strips according to the present invention. 1... Test reagent layer, 2... Color tone layer. 3... Highly absorbent part, 4... Base material. 5... Test paper for inspection
Claims (1)
の含有量に応じて色調変化をする検査試薬を含む検査試
薬層と、該検査試薬層の近傍に該検査試薬層に含まれる
検査試薬主要成分以外の検査試薬層構成材料を実質的に
含み、染料等によって着色された判定基準用の色調層と
を設け、かつ該検査試薬層及び色調層の近傍に高吸水性
部を設けたことを特徴とする検査用試験紙。A test reagent layer containing a test reagent that changes color tone depending on the content of the test target substance in the test liquid is provided on the surface of the base material of the test strip, and a test reagent layer containing a test reagent that changes color tone depending on the content of the test target substance in the test liquid is provided near the test reagent layer. A test reagent layer containing substantially all constituent materials other than the main components of the test reagent, and a color tone layer for judgment standards colored with a dye or the like, and a highly water-absorbing portion in the vicinity of the test reagent layer and the color tone layer. An inspection test strip characterized by:
Priority Applications (7)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP1643287A JPS63184060A (en) | 1987-01-27 | 1987-01-27 | Examination test paper |
| EP87906596A EP0290610B1 (en) | 1986-10-08 | 1987-10-07 | Method for inspecting bodily fluids |
| DE19873752267 DE3752267T2 (en) | 1986-10-08 | 1987-10-07 | Device for examining body fluids |
| EP94101488A EP0605394B1 (en) | 1986-10-08 | 1987-10-07 | Device for testing body fluids |
| PCT/JP1987/000753 WO1988002860A1 (en) | 1986-10-08 | 1987-10-07 | Bodily fluid inspection device |
| DE3750397T DE3750397T2 (en) | 1986-10-08 | 1987-10-07 | METHOD FOR TESTING BODY LIQUIDS. |
| US07/746,190 US5178831A (en) | 1986-10-08 | 1991-08-15 | Device for testing body fluids |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP1643287A JPS63184060A (en) | 1987-01-27 | 1987-01-27 | Examination test paper |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| JPS63184060A true JPS63184060A (en) | 1988-07-29 |
Family
ID=11916074
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP1643287A Pending JPS63184060A (en) | 1986-10-08 | 1987-01-27 | Examination test paper |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPS63184060A (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS6425753U (en) * | 1987-08-06 | 1989-02-13 | ||
| JPH0267263U (en) * | 1988-11-11 | 1990-05-22 | ||
| WO2006080438A1 (en) * | 2005-01-28 | 2006-08-03 | Mochida Pharmaceutical Co., Ltd. | Immunochromatographic test instrument and semiquantitative method using the same |
-
1987
- 1987-01-27 JP JP1643287A patent/JPS63184060A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS6425753U (en) * | 1987-08-06 | 1989-02-13 | ||
| JPH0267263U (en) * | 1988-11-11 | 1990-05-22 | ||
| WO2006080438A1 (en) * | 2005-01-28 | 2006-08-03 | Mochida Pharmaceutical Co., Ltd. | Immunochromatographic test instrument and semiquantitative method using the same |
| JP4988546B2 (en) * | 2005-01-28 | 2012-08-01 | 持田製薬株式会社 | Immunochromatographic test device and semi-quantitative method using the same |
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