JPS6122906B2 - - Google Patents
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- Publication number
- JPS6122906B2 JPS6122906B2 JP9890278A JP9890278A JPS6122906B2 JP S6122906 B2 JPS6122906 B2 JP S6122906B2 JP 9890278 A JP9890278 A JP 9890278A JP 9890278 A JP9890278 A JP 9890278A JP S6122906 B2 JPS6122906 B2 JP S6122906B2
- Authority
- JP
- Japan
- Prior art keywords
- layer
- blood
- color
- reagent
- blood chemistry
- 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.)
- Expired
Links
- 210000004369 blood Anatomy 0.000 claims description 66
- 239000008280 blood Substances 0.000 claims description 66
- 239000000463 material Substances 0.000 claims description 53
- 239000003153 chemical reaction reagent Substances 0.000 claims description 43
- 238000004458 analytical method Methods 0.000 claims description 33
- 239000000843 powder Substances 0.000 claims description 21
- 229910052751 metal Inorganic materials 0.000 claims description 13
- 239000002184 metal Substances 0.000 claims description 13
- 238000003892 spreading Methods 0.000 claims description 6
- 239000010410 layer Substances 0.000 description 124
- 238000011161 development Methods 0.000 description 17
- 238000000034 method Methods 0.000 description 9
- 239000000203 mixture Substances 0.000 description 8
- 108010010803 Gelatin Proteins 0.000 description 7
- 239000000306 component Substances 0.000 description 7
- 230000000694 effects Effects 0.000 description 7
- 229920000159 gelatin Polymers 0.000 description 7
- 239000008273 gelatin Substances 0.000 description 7
- 235000019322 gelatine Nutrition 0.000 description 7
- 235000011852 gelatine desserts Nutrition 0.000 description 7
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 6
- 238000001035 drying Methods 0.000 description 6
- 239000008103 glucose Substances 0.000 description 6
- 229920002799 BoPET Polymers 0.000 description 5
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 5
- 239000011230 binding agent Substances 0.000 description 5
- 238000001704 evaporation Methods 0.000 description 5
- 230000008020 evaporation Effects 0.000 description 5
- 239000011148 porous material Substances 0.000 description 5
- 230000002265 prevention Effects 0.000 description 5
- 239000000126 substance Substances 0.000 description 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 5
- 102000013142 Amylases Human genes 0.000 description 4
- 108010065511 Amylases Proteins 0.000 description 4
- 229910052782 aluminium Inorganic materials 0.000 description 4
- TZCXTZWJZNENPQ-UHFFFAOYSA-L barium sulfate Chemical compound [Ba+2].[O-]S([O-])(=O)=O TZCXTZWJZNENPQ-UHFFFAOYSA-L 0.000 description 4
- 238000011088 calibration curve Methods 0.000 description 4
- 239000006185 dispersion Substances 0.000 description 4
- 239000007788 liquid Substances 0.000 description 4
- 230000035699 permeability Effects 0.000 description 4
- 239000000243 solution Substances 0.000 description 4
- 239000004382 Amylase Substances 0.000 description 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 description 3
- 235000019418 amylase Nutrition 0.000 description 3
- 239000007864 aqueous solution Substances 0.000 description 3
- 238000004159 blood analysis Methods 0.000 description 3
- 230000000052 comparative effect Effects 0.000 description 3
- 238000009472 formulation Methods 0.000 description 3
- 238000005259 measurement Methods 0.000 description 3
- 239000012528 membrane Substances 0.000 description 3
- -1 polyethylene terephthalate Polymers 0.000 description 3
- 229920000139 polyethylene terephthalate Polymers 0.000 description 3
- 239000005020 polyethylene terephthalate Substances 0.000 description 3
- 238000004445 quantitative analysis Methods 0.000 description 3
- 210000002966 serum Anatomy 0.000 description 3
- RLFWWDJHLFCNIJ-UHFFFAOYSA-N 4-aminoantipyrine Chemical compound CN1C(C)=C(N)C(=O)N1C1=CC=CC=C1 RLFWWDJHLFCNIJ-UHFFFAOYSA-N 0.000 description 2
- NLXLAEXVIDQMFP-UHFFFAOYSA-N Ammonia chloride Chemical compound [NH4+].[Cl-] NLXLAEXVIDQMFP-UHFFFAOYSA-N 0.000 description 2
- 229920000945 Amylopectin Polymers 0.000 description 2
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 2
- PXHVJJICTQNCMI-UHFFFAOYSA-N Nickel Chemical compound [Ni] PXHVJJICTQNCMI-UHFFFAOYSA-N 0.000 description 2
- BQCADISMDOOEFD-UHFFFAOYSA-N Silver Chemical compound [Ag] BQCADISMDOOEFD-UHFFFAOYSA-N 0.000 description 2
- PPBRXRYQALVLMV-UHFFFAOYSA-N Styrene Chemical compound C=CC1=CC=CC=C1 PPBRXRYQALVLMV-UHFFFAOYSA-N 0.000 description 2
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 description 2
- IISBACLAFKSPIT-UHFFFAOYSA-N bisphenol A Chemical compound C=1C=C(O)C=CC=1C(C)(C)C1=CC=C(O)C=C1 IISBACLAFKSPIT-UHFFFAOYSA-N 0.000 description 2
- 230000000903 blocking effect Effects 0.000 description 2
- 229920002678 cellulose Polymers 0.000 description 2
- 238000006243 chemical reaction Methods 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 238000004737 colorimetric analysis Methods 0.000 description 2
- 238000004040 coloring Methods 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 238000009792 diffusion process Methods 0.000 description 2
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 2
- 229910052737 gold Inorganic materials 0.000 description 2
- 239000010931 gold Substances 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 description 2
- 229920000515 polycarbonate Polymers 0.000 description 2
- 239000004417 polycarbonate Substances 0.000 description 2
- 229910052709 silver Inorganic materials 0.000 description 2
- 239000004332 silver Substances 0.000 description 2
- 239000012086 standard solution Substances 0.000 description 2
- 239000012463 white pigment Substances 0.000 description 2
- 229910052725 zinc Inorganic materials 0.000 description 2
- 239000011701 zinc Substances 0.000 description 2
- PWJNDVAKQLOWRZ-UHFFFAOYSA-N 1-hydroxynaphthalene-2-sulfonic acid Chemical compound C1=CC=C2C(O)=C(S(O)(=O)=O)C=CC2=C1 PWJNDVAKQLOWRZ-UHFFFAOYSA-N 0.000 description 1
- 229920008347 Cellulose acetate propionate Polymers 0.000 description 1
- 229920001747 Cellulose diacetate Polymers 0.000 description 1
- 229920002284 Cellulose triacetate Polymers 0.000 description 1
- VYZAMTAEIAYCRO-UHFFFAOYSA-N Chromium Chemical compound [Cr] VYZAMTAEIAYCRO-UHFFFAOYSA-N 0.000 description 1
- RYGMFSIKBFXOCR-UHFFFAOYSA-N Copper Chemical compound [Cu] RYGMFSIKBFXOCR-UHFFFAOYSA-N 0.000 description 1
- 108010015776 Glucose oxidase Proteins 0.000 description 1
- 239000004366 Glucose oxidase Substances 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- 102000003992 Peroxidases Human genes 0.000 description 1
- ATJFFYVFTNAWJD-UHFFFAOYSA-N Tin Chemical compound [Sn] ATJFFYVFTNAWJD-UHFFFAOYSA-N 0.000 description 1
- 235000010724 Wisteria floribunda Nutrition 0.000 description 1
- NNLVGZFZQQXQNW-ADJNRHBOSA-N [(2r,3r,4s,5r,6s)-4,5-diacetyloxy-3-[(2s,3r,4s,5r,6r)-3,4,5-triacetyloxy-6-(acetyloxymethyl)oxan-2-yl]oxy-6-[(2r,3r,4s,5r,6s)-4,5,6-triacetyloxy-2-(acetyloxymethyl)oxan-3-yl]oxyoxan-2-yl]methyl acetate Chemical compound O([C@@H]1O[C@@H]([C@H]([C@H](OC(C)=O)[C@H]1OC(C)=O)O[C@H]1[C@@H]([C@@H](OC(C)=O)[C@H](OC(C)=O)[C@@H](COC(C)=O)O1)OC(C)=O)COC(=O)C)[C@@H]1[C@@H](COC(C)=O)O[C@@H](OC(C)=O)[C@H](OC(C)=O)[C@H]1OC(C)=O NNLVGZFZQQXQNW-ADJNRHBOSA-N 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 235000019270 ammonium chloride Nutrition 0.000 description 1
- 230000004888 barrier function Effects 0.000 description 1
- 239000010953 base metal Substances 0.000 description 1
- 239000012503 blood component Substances 0.000 description 1
- 230000037237 body shape Effects 0.000 description 1
- 229920006217 cellulose acetate butyrate Polymers 0.000 description 1
- 239000011651 chromium Substances 0.000 description 1
- 229910052804 chromium Inorganic materials 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 239000003086 colorant Substances 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 229920001577 copolymer Polymers 0.000 description 1
- 229910052802 copper Inorganic materials 0.000 description 1
- 239000010949 copper Substances 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 239000011888 foil Substances 0.000 description 1
- 229940116332 glucose oxidase Drugs 0.000 description 1
- 235000019420 glucose oxidase Nutrition 0.000 description 1
- 235000011187 glycerol Nutrition 0.000 description 1
- 230000002209 hydrophobic effect Effects 0.000 description 1
- 239000002346 layers by function Substances 0.000 description 1
- 229910052759 nickel Inorganic materials 0.000 description 1
- 239000002736 nonionic surfactant Substances 0.000 description 1
- 229920005787 opaque polymer Polymers 0.000 description 1
- 238000011017 operating method Methods 0.000 description 1
- 238000001579 optical reflectometry Methods 0.000 description 1
- 239000012466 permeate Substances 0.000 description 1
- 108040007629 peroxidase activity proteins Proteins 0.000 description 1
- 210000002381 plasma Anatomy 0.000 description 1
- 229910052697 platinum Inorganic materials 0.000 description 1
- 229920000728 polyester Polymers 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 238000011002 quantification Methods 0.000 description 1
- 230000005855 radiation Effects 0.000 description 1
- 229920002050 silicone resin Polymers 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 239000000758 substrate Substances 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 229910052718 tin Inorganic materials 0.000 description 1
- 239000011135 tin Substances 0.000 description 1
- 239000004408 titanium dioxide Substances 0.000 description 1
- OGIDPMRJRNCKJF-UHFFFAOYSA-N titanium oxide Inorganic materials [Ti]=O OGIDPMRJRNCKJF-UHFFFAOYSA-N 0.000 description 1
Landscapes
- Investigating Or Analyzing Non-Biological Materials By The Use Of Chemical Means (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
Description
【発明の詳細な説明】
本発明は多層一体型の血液化学分析材料に関す
るもので、特に血液中の化学成分を定量するのに
全血、血漿又は血清を用いうることを特徴とする
ものである。DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a multilayer integrated blood chemistry analysis material, and is particularly characterized in that whole blood, plasma, or serum can be used to quantify chemical components in blood. .
血液中の化学成分を分析するために用いる血液
試料としては全血と、面倒な有色・有形成分除去
操作を行なつた後の液体部分、即ち、血漿または
血清とがある。血液の簡易迅速定量又は緊急検査
には、全血を用いることのできる方法が、好都合
なことは言うまでもない。 Blood samples used to analyze chemical components in blood include whole blood and a liquid portion, ie, plasma or serum, after a troublesome procedure for removing colored and formed components. Needless to say, a method that can use whole blood is advantageous for simple and rapid quantitative determination or emergency testing of blood.
技術的困難のために、全血を試料とし、しかも
乾式の簡易迅速な血液化学定量分析法およびその
ための分析材料は、まだ出現していない。血液を
乾式で簡易迅速に定量するものとして、多孔性展
開層を備えたことを特徴とする多層一体型血液化
学分析材料が特開昭49−53888号、同50−137192
号、同51−40191号、同52−3488号、同52−
131786号、同53−24893号、米国特許第3992158
号、同3526480号、同3663374号などの各明細書お
よび第10回国際臨床化学会（M′exico 市、1978
年２月26日〜３月３日）でのJ.N.Eikenberryら
の発表予稿集などに記載されている。これらの血
液化学分析材料の基本構成は多孔性展開層と試薬
層との組合わせであるが、試薬層は機能を分離し
て、第一試薬層の下に第二試薬層又は発色層又は
検出層又は色素受容層などと呼ばれる複数層に構
成することもある。又、複数試薬層の中間に色遮
蔽層、バリヤ層などと呼ばれる中間層を設けるこ
ともある。又展開層中に試薬を包含させて展開層
と試薬層が合体された構造のものもあるが、いず
れにしても「展開層」と「試薬層」の二つの作用
層が基本である。 Due to technical difficulties, a simple and rapid dry method for quantitative analysis of blood chemistry using whole blood as a sample and materials for analysis have not yet appeared. A multi-layer integrated blood chemistry analysis material characterized by having a porous development layer is disclosed in JP-A-49-53888 and JP-A-50-137192 for simple and quick dry quantitative determination of blood.
No. 51-40191, No. 52-3488, No. 52-
No. 131786, No. 53-24893, U.S. Patent No. 3992158
No. 3526480, No. 3663374, and the 10th International Society of Clinical Chemistry (M'exico City, 1978).
It is described in the proceedings of the presentation by JNEikenberry et al. The basic composition of these blood chemistry analysis materials is a combination of a porous development layer and a reagent layer. It may be composed of multiple layers called a dye-receiving layer or a dye-receiving layer. Further, an intermediate layer called a color shielding layer, a barrier layer, etc. may be provided between the plurality of reagent layers. There are also structures in which the developing layer and reagent layer are combined by containing a reagent in the developing layer, but in any case, there are basically two active layers: a "developing layer" and a "reagent layer."
この血液化学分析材料上に滴下された血液試料
は、多孔性展開層によつて一様に拡げられ試薬層
面に浸入する。試薬層中には、血液中のある成分
と反応して終局的に発色、着色又は変色反応に導
く系が組込まれているので、結局血液中の成分は
比色法によつて定量することができるような仕組
みになつている。 The blood sample dropped onto the blood chemical analysis material is uniformly spread by the porous spreading layer and penetrates into the surface of the reagent layer. The reagent layer contains a system that reacts with certain components in the blood and ultimately leads to color development, coloring, or color change reactions, so the components in the blood cannot be quantified by colorimetry. The system is set up so that it can be done.
かかる既知の多層一体型血液化学定量分析材料
は、試料として血清の他に全血をも適用しうると
前記の文献に記載されているので、記載の方法に
より全血でテストした所、色遮蔽物質が主として
白色顔料からなつているので、色遮蔽性を持たせ
るためには約150μｍ以上の厚さにする必要があ
り、系が濡れている場合はこの厚さでも色遮蔽効
果が充分でないことがわかつた。又系が厚くなる
と製造上の不便の他に血液の浸透性が著るしく阻
害されることがわかつた。そこで種々検討の結
果、既知の多層一体型血液化学定量分析材料を全
血用として用いられるようにするためには、良好
な水浸透性のなるべく層厚の小さい色遮蔽層を設
けることが不可欠であり、色遮蔽層として金属粉
末を含むものがもつとも効果があることが判明し
本発明に到達した。更に本発明に用いられる色遮
蔽層は、試薬層中に用いる試薬として着色試薬を
用いねばならない場合において、有色試薬の色を
隠蔽する目的で、有色試薬層の下に（すなわち、
有色試薬層の多孔性展開層から遠い側の表面に接
して）設けると極めて有効なことがわかつた。 It is stated in the above-mentioned document that such a known multi-layer integrated blood chemistry quantitative analysis material can be applied to whole blood as well as serum as a sample, so when tested with whole blood by the method described, color shielding was observed. Since the material is mainly composed of white pigment, it needs to be approximately 150 μm thick or more in order to have color-shielding properties, and if the system is wet, even this thickness may not provide sufficient color-shielding effect. I understood. It has also been found that when the system becomes thicker, it is not only inconvenient in manufacturing, but also significantly impedes blood permeability. As a result of various studies, we found that in order to use the known multilayer integrated blood chemistry quantitative analysis material for whole blood, it is essential to provide a color shielding layer with good water permeability and as thin a layer as possible. It was found that a color shielding layer containing metal powder was also effective, and the present invention was achieved. Furthermore, in the case where a colored reagent must be used as a reagent in the reagent layer, the color shielding layer used in the present invention is provided under the colored reagent layer (i.e.,
It has been found that it is extremely effective to provide the colored reagent layer (in contact with the surface of the colored reagent layer on the side far from the porous development layer).
本発明は、
(1) 多孔性展開層と試薬層とからなる組合せを含
む多層一体型の血液化学分析材料において、金
属粉末を含む水浸透性の色遮蔽層を有すること
を特徴とする多層一体型の血液化学分析材料、
および、
(2) 該三層を有する多層一体型の血液化学分析材
料を支持しうる支持体を有する(1)に記載の多層
一体型の血液化学分析材料である。 The present invention provides (1) a multilayer integrated blood chemistry analysis material including a combination of a porous spreading layer and a reagent layer, which is characterized by having a water-permeable color-shielding layer containing metal powder; Blood chemistry analysis material for body shape,
and (2) the multilayer integrated blood chemistry analysis material according to (1), which has a support capable of supporting the multilayer integrated blood chemistry analysis material having the three layers.
本発明は色遮蔽層が設けられた多層一体型の血
液分析材料を添付図面に記載した具体例によつて
説明する。 DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention will be explained by way of a specific example of a multi-layer integrated blood analysis material provided with a color-shielding layer, as shown in the accompanying drawings.
第１図は色遮蔽層１が多孔性展開層２と試薬層
３との間に設けられている分析材料の模型図で、
血液は矢印Ａの方向から滴下され、比色定量は矢
印Ｂの方向からなされる。 FIG. 1 is a schematic diagram of an analytical material in which a color shielding layer 1 is provided between a porous development layer 2 and a reagent layer 3.
Blood is dropped from the direction of arrow A, and colorimetric determination is made from the direction of arrow B.
第２図は複数の試薬層を有する分析材料の模型
図で、色遮蔽層は試薬層の中間にも位置しうるこ
とを示したもので、多孔性展開層２、第一試薬層
３、色遮蔽層１、第二試薬層又は別の機能層４の
順に構成される。特に第一試薬層３が有色材料か
らなり着色している時は、色遮蔽層は本位置にあ
ることが必要である。 Figure 2 is a model diagram of an analytical material having multiple reagent layers, showing that the color shielding layer can also be located between the reagent layers. A shielding layer 1 and a second reagent layer or another functional layer 4 are constructed in this order. In particular, when the first reagent layer 3 is made of a colored material and is colored, it is necessary that the color shielding layer be in this position.
色遮蔽層は金属粉末を適当なバインダ物質に分
散した層である。金属としては白金、金、銀、ニ
ツケル、クロム、アルミニウム、亜鉛、錫、銅な
どを用いることができるが白色地金の金属が好ま
しい。金属粉末の形は球状、多面体状、箔状（薄
板状）いずれでも用いることができ、その大きさ
（サイズ）は、色遮蔽層の厚さの約半分より小さ
いものを用いることができ、従つてその大きさは
層厚に依存することになる。また箔状の粉末の場
合は薄板の投映像の最大幅の長さ粉末の大きさ
（サイズ）とみることが適当であり、この意味に
おける粉末の大きさは、色遮蔽層の厚さにほぼ等
しい大きさより小さいものを用いることができ
る。金属粉末の大きさは径が約１μｍから約20μ
ｍまでの範囲である。更に具体的な好例は、面積
が約１μm2から約50μm2の範囲で厚さが約２μｍ
以下の箔状のアルミニウム粉末があげられる。 The color blocking layer is a layer of metal powder dispersed in a suitable binder material. As the metal, platinum, gold, silver, nickel, chromium, aluminum, zinc, tin, copper, etc. can be used, but a white base metal is preferable. The shape of the metal powder can be spherical, polyhedral, or foil (thin plate), and its size can be smaller than about half the thickness of the color shielding layer. Therefore, its size depends on the layer thickness. In addition, in the case of foil-like powder, it is appropriate to consider the length of the maximum width of the projected image of the thin plate as the size of the powder, and the size of the powder in this sense is approximately equal to the thickness of the color shielding layer. A smaller than equal size can be used. The size of the metal powder is approximately 1μm to approximately 20μm in diameter.
The range is up to m. A more specific example is a film with an area in the range of about 1 μm 2 to about 50 μm 2 and a thickness of about 2 μm.
The following foil-shaped aluminum powders are mentioned.
色遮蔽層の設け方は、金、銀、アルミニウム、
亜鉛などの金属粉末を適当なバインダ（結合剤）
物質に分散した液を塗設する方法によることがで
きる。例えば上記の金属粉末をゼラチンの如き親
水性バインダに分散した液、又はセルロースエス
テルのような疎水性バインダを分散し乾燥後多孔
性になるような組成液を乾燥後の層厚が約２μｍ
から約50μｍまでの範囲になるように塗布し、乾
燥する。金属粉末としては塊状粉末、箔状粉末を
用いることができ、特に箔状粉末を利用すると色
遮蔽効果が優れ、その場合には厚さが約２μｍか
ら約20μｍまでの色遮蔽層でよく、従つて水滲透
性も良好であることがわかつた。本発明における
色遮蔽層はその層が水で濡れた状態であつても、
硫酸バリウムや酸化チタンなどを用いた従来公知
の色遮蔽層におけるように色遮蔽効果が減ずる欠
点が全く認められなかつた。又金属粉末はその表
面が良好な光反射性であるので、本発明の色遮蔽
層は発色像の比色定量に際し、良好なバツクグラ
ウンドとなるものである。 The color shielding layer can be provided using gold, silver, aluminum,
Metal powder such as zinc with a suitable binder (binding agent)
This can be done by applying a liquid dispersed in a substance. For example, a liquid in which the above metal powder is dispersed in a hydrophilic binder such as gelatin, or a composition liquid in which a hydrophobic binder such as cellulose ester is dispersed and becomes porous after drying has a layer thickness of about 2 μm after drying.
Apply to a thickness of approximately 50 μm and dry. As the metal powder, a lump powder or a foil-like powder can be used. In particular, when a foil-like powder is used, the color shielding effect is excellent. In that case, a color shielding layer with a thickness of about 2 μm to about 20 μm may be used. It was also found that the water permeability was good. Even when the color shielding layer in the present invention is wet with water,
There were no defects in the color shielding effect that were observed in conventionally known color shielding layers using barium sulfate, titanium oxide, or the like. Furthermore, since the surface of the metal powder has good light reflectivity, the color shielding layer of the present invention provides a good background for colorimetric determination of a colored image.
本発明の多層一体型の血液化学分析材料は、多
孔性展開層、試薬層および色遮蔽層を必須の構成
要素（層）として有する血液化学分析材料である
が、必要に応じて、すなわち用途、用いる分析装
置又は分析方法、操作方法又は各層を構成する素
材などにもとづく要請に従つて、支持体、多孔性
展開層から離脱しうる水分蒸発防止カバー、少な
くとも一つの小孔を有する防水性層又は過層の
うちから適宜に選択していずれかをさらに付加し
た構成の多層一体型の血液化学分析材料とするこ
ともできる。 The multilayer integrated blood chemistry analysis material of the present invention is a blood chemistry analysis material that has a porous development layer, a reagent layer, and a color shielding layer as essential constituent elements (layers). Depending on the analytical equipment or analytical method used, the operating method, or the materials constituting each layer, the support, a moisture evaporation prevention cover that can be separated from the porous spreading layer, a waterproof layer having at least one small hole, or It is also possible to provide a multi-layer integrated blood chemistry analysis material having a structure in which one of the super-layers is further added by appropriately selecting one of the super-layers.
支持体を有する場合、支持体は試薬層の多孔性
展開層と反対側の表面に接して設ける。複数の試
薬層を有する場合には試料を滴下する側から最も
遠い試薬層の多孔性展開層と反対側の表面に接し
て透明支持体を設ける。透明支持体はポリエステ
ル（例、ポリエチレンテレフタレート）、ポリカ
ルボネート（例、ビスフエノールＡのポリカルボ
ネート）、セルロースエステル（例、セルロース
ジアセテート、セルローストリアセテート、セル
ロースアセテートプロピオネート、セルロースア
セテートブチレート）等の近紫外線、可視光線、
近赤外線をよく透過しうる（透明性がよい）もの
で、約10μｍから約0.5mmまでの範囲の厚さのフ
イルムを用いることができる。また支持体として
シリコーン樹脂等の離型剤を塗布した半透明又は
不透明な紙、または透明、半透明又は不透明なポ
リマーフイルムのテープを試薬層に貼りつけて設
けることもできる。離型剤を塗布した支持体を用
いる場合、分析するまでは血液化学分析材料の保
護の役目をし、測定する際にはこれを剥してから
測定することができる。 When a support is provided, the support is provided in contact with the surface of the reagent layer opposite to the porous development layer. In the case of having a plurality of reagent layers, a transparent support is provided in contact with the surface of the reagent layer furthest from the side where the sample is dropped, on the side opposite to the porous development layer. The transparent support is made of polyester (e.g., polyethylene terephthalate), polycarbonate (e.g., polycarbonate of bisphenol A), cellulose ester (e.g., cellulose diacetate, cellulose triacetate, cellulose acetate propionate, cellulose acetate butyrate). Near ultraviolet rays, visible light, etc.
A film that can transmit near-infrared rays well (has good transparency) and has a thickness in the range of about 10 μm to about 0.5 mm can be used. Alternatively, a translucent or opaque paper coated with a release agent such as a silicone resin, or a transparent, semitransparent or opaque polymer film tape may be attached to the reagent layer as a support. When using a support coated with a release agent, it serves to protect the blood chemistry analysis material until it is analyzed, and the support can be peeled off before measurement.
多孔性展開層から離脱しうる水分蒸発防止カバ
ーを有する場合、水分蒸発防止カバーは多孔性展
開層を覆うように設ける。水分蒸発防止カバーの
形、素材、設け方は実願昭53−59886号明細書の
記載に従うことができる。 When a moisture evaporation prevention cover that can be separated from the porous development layer is provided, the moisture evaporation prevention cover is provided to cover the porous development layer. The shape, material, and method of providing the moisture evaporation prevention cover can follow the description in the specification of Utility Model Application No. 53-59886.
少なくとも一つの小孔を有する防水性層は多孔
性展開層の試薬層から遠い側の表面に接して設け
る。小孔を有する防水性層における小孔の形、大
きさ、その数、防水性層の形、素材、設け方は実
願昭53−59888号明細書の記載に従うことができ
る。 A waterproof layer having at least one small pore is provided in contact with the surface of the porous spreading layer remote from the reagent layer. The shape, size, and number of the pores in the waterproof layer having pores, the shape, material, and method of providing the waterproof layer can follow the description in the specification of Japanese Utility Model Application No. 53-59888.
血液中の有形成分を除去しうる過層を有する
場合、過層は小孔を有する防水性層の多孔性展
開層に接している表面と反対側の表面に接して設
けられる。血液中の有形成分を除去しうる過層
の形、素材、設け方は実願昭53−77177号明細書
の記載に従うことができる。なお、過層は多孔
性展開層の試薬層から遠い表面に接して設けるこ
ともでき、この場合には過層の上（すなわち
過層の多孔性展開層に接していない表面）を覆う
ようにして水分蒸発防止カバー又は小孔を有する
防水性層を設けることができる。 When having an overlayer capable of removing formed components in blood, the overlayer is provided in contact with the surface of the waterproof layer having small pores opposite to the surface in contact with the porous spreading layer. The shape, material, and method of providing the superlayer capable of removing formed components in the blood can be according to the description in Utility Model Application No. 53-77177. Note that the superlayer can be provided in contact with the surface of the porous development layer that is far from the reagent layer, and in this case, the superlayer should be provided to cover the top of the superlayer (i.e., the surface of the superlayer that is not in contact with the porous development layer). A moisture evaporation prevention cover or a waterproof layer with small holes can be provided.
本発明の多層一体型の血液化学分析材料は、金
属粉末を含む良好な色遮蔽層を有するために次の
如き特色を有する。 The multilayer integrated blood chemistry analysis material of the present invention has the following characteristics in order to have a good color-shielding layer containing metal powder.
(1) 試薬として有色試薬を利用することができ
る。(1) Colored reagents can be used as reagents.
(2) 使用時に試料として全血を用いてもその色を
完全に遮蔽することができる。特にこの色遮蔽
効果は分析材料が水で湿つていても完全である
ので、水系発色反応が終了後乾燥処理操作なし
に直ちに比色等の方法により定量ができ、多層
一体型の血液化学材料の迅速性を一段と有利に
するものである。(2) Even if whole blood is used as a sample during use, its color can be completely blocked. In particular, this color-shielding effect is complete even when the analytical material is wet with water, so it can be quantitatively determined by colorimetry or other methods immediately after the completion of the aqueous coloring reaction without drying, making it possible to use multilayer blood chemistry materials. This makes the speed of processing even more advantageous.
(3) 色遮蔽効果がすぐれているので層の厚さは実
質的に約20μｍ以下の厚さで充分であるので、
製造時の塗布乾燥が従来のものより非常に容易
となり、かつ血液の浸透性を阻害することがな
いので分析を円滑に行うことができる。(3) Since the color shielding effect is excellent, a layer thickness of approximately 20 μm or less is sufficient.
Application and drying during manufacturing is much easier than with conventional methods, and since it does not impede blood permeability, analysis can be carried out smoothly.
実施例 １
血中グルコース測定用多層一体型の血液化学分
析材料の例。厚さ170μｍの写真材料用親水性下
塗り済みのポリエチレンテレフタレート（PET
と略す。フイルムの上に、１m2当り次の処方の試
薬層溶液（ゼラチン水溶液）を塗布乾燥して試薬
層とした。Example 1 An example of a multilayer integrated blood chemistry analysis material for measuring blood glucose. 170 μm thick polyethylene terephthalate (PET) with hydrophilic undercoat for photographic materials.
It is abbreviated as A reagent layer solution (gelatin aqueous solution) having the following formulation was applied per 1 m 2 of the film and dried to form a reagent layer.
試薬層溶液の組成 10重量％ゼラチン水溶液 210ｇ １−ナフトール−２−スルホン酸 ナトリウム １ｇ ４−アミノアンチピリン 0.52ｇ グルコースオキシダーゼ 13000単位 ペルオキシダーゼ 6700単位 ノニオン界面活性剤 ３ｇ グリセリン 30ｇ NaOHによりPHを6.5に調節する。Composition of reagent layer solution 10% gelatin aqueous solution 210g 1-naphthol-2-sulfonic acid Sodium 1g 4-aminoantipyrine 0.52g Glucose oxidase 13000 units Peroxidase 6700 units Nonionic surfactant 3g Glycerin 30g Adjust PH to 6.5 with NaOH.
次にこの層の上に次の処方の光拡散層分散液を
塗布乾燥し、乾燥後の厚さ15μｍの光拡散層を積
層した。 Next, a light-diffusing layer dispersion having the following formulation was applied and dried on this layer, and a dried light-diffusing layer having a thickness of 15 μm was laminated thereon.
光拡散層分散液の組成
10重量％ゼラチン水溶液 30ｇ
硫酸バリウム 10ｇ
次にこの層の上に次の処方の色遮蔽層分散液を
塗布乾燥し、乾燥後の厚さ15μｍの色遮蔽層を設
けた。Composition of light diffusion layer dispersion: 10% by weight gelatin aqueous solution 30g Barium sulfate 10g Next, a color shielding layer dispersion having the following formulation was applied onto this layer and dried to form a color shielding layer with a thickness of 15 μm after drying. .
色遮蔽層分散液の組成
10重量％ゼラチン水溶液 160ｇ
箔状アルミニウム粉末（不定形、
サイズ平均６μｍ） ３ｇ
この色遮蔽層の表面を水で湿潤させてから厚さ
150μｍ、孔径1.2μｍのメンブランフイルター
（富士写真フイルム(株)製ミクロフイルター120）を
ラミネートして接着し多孔性展開層を形成して多
層一体型の血液化学分析材料をつくつた。全血10
μを多孔性展開層上に滴下して、血液展開後
PETフイルム側から観察した所、血液の赤色は
完全に遮蔽され、試薬層中にはグルコースの量に
応じた発色が観察された。Composition of color-shielding layer dispersion: 10% by weight aqueous gelatin solution 160g Foil-shaped aluminum powder (amorphous, average size 6μm) 3g Wet the surface of this color-shielding layer with water and then determine the thickness.
A membrane filter (Microfilter 120, manufactured by Fuji Photo Film Co., Ltd.) having a diameter of 150 μm and a pore size of 1.2 μm was laminated and adhered to form a porous spread layer to produce a multilayer integrated blood chemistry analysis material. whole blood 10
After blood development by dropping μ onto the porous development layer,
When observed from the PET film side, the red color of blood was completely blocked, and color development corresponding to the amount of glucose was observed in the reagent layer.
比較例 １
一方、比較例として、公知の多層一体型血液化
学分析材料として特開昭51−40191号明細書実施
例１に記載の材料を明細書の記載に従つて作製し
た。この材料においては色遮蔽層（放射ブロツキ
ング層）は、白色顔料（二酸化チタン微粉末）が
ゼラチン中に分散された構成のものであるので、
色遮蔽層の厚さは約150μｍ、すなわち本発明の
色遮蔽層の厚さの10倍ほどの厚さにしないと色遮
蔽効果が完全でなかつた。また、この大きな厚さ
を血液成分が滲透通過するために、本発明の材料
を用いる場合よりも多量の血液試料と長時間を要
することがわかつた。Comparative Example 1 On the other hand, as a comparative example, a material described in Example 1 of the specification of JP-A-51-40191 as a known multilayer integrated blood chemistry analysis material was prepared according to the description in the specification. In this material, the color shielding layer (radiation blocking layer) is composed of white pigment (titanium dioxide fine powder) dispersed in gelatin.
The color shielding effect was not complete unless the thickness of the color shielding layer was about 150 μm, that is, about 10 times the thickness of the color shielding layer of the present invention. Furthermore, it was found that in order for blood components to permeate through this large thickness, a larger amount of blood sample and a longer time were required than when using the material of the present invention.
実施例１に記載した本発明の多層一体型血液化
学分析材料と比較例１に記載した従来公知の多層
一体型血液化学分析材料とを用い、全血を試料と
し、その中に含まれるグルコースの定量を行なつ
た結果を第３図に示した。図中、直線は本発明
の血液化学分析材料によるもので良好な定量性が
認められたが、従来公知の血液分析材料を用いる
と破線Ｐの如く定量性が著るしく劣ることがわか
つた。〔条件：毎回血液量10μ、30℃、滴下後
10分で発色濃度をマクベス濃度計でグリーンフイ
ルターを用いて測定した。〕
実施例 ２
血中グルコース測定用多層一体型の血液化学分
析材料の例
光拡散層を設けなかつたほかは実施例１と同様
に実施してPETフイルム側から観察したとこ
ろ、実施例１と同様な結果が得られた。 Using the multilayer integrated blood chemistry analysis material of the present invention described in Example 1 and the conventionally known multilayer integrated blood chemistry analysis material described in Comparative Example 1, whole blood was taken as a sample, and the glucose contained therein was determined. The results of the quantitative determination are shown in FIG. In the figure, the straight line indicates good quantitative performance using the blood chemistry analysis material of the present invention, but it was found that when conventional blood analysis materials were used, the quantitative performance was significantly inferior as shown by the broken line P. [Conditions: Blood volume 10μ each time, 30℃, after dripping
After 10 minutes, the color density was measured using a Macbeth densitometer with a green filter. ] Example 2 Example of a multilayer integrated blood chemistry analysis material for blood glucose measurement The same procedure as in Example 1 was performed except that the light diffusion layer was not provided, and observation from the PET film side revealed the same results as in Example 1. The results were obtained.
実施例 ３
有色試薬を用いるアミラーゼ定量用多層一体型
の血液分析材料
実施例１と同様のPETフイルム上に、１m2当
り３ｇのゼラチンと、２ｇの媒染剤（スチレンと
Ｎ，Ｎ−ジメチル−Ｎ−（３−マレイミドプロピ
ル）アンモニウムクロリドとの共重合体）を含む
検出層を塗布によつて設けた。その上に実施例１
と同様の操作により乾燥後の厚さ20μｍのアルミ
ニウム箔状微粉末を含む色遮蔽層を設けた。更に
その上に、アミラーゼ酵素の基質として、色素結
合アミロペクチン溶液（Reacton Red 2B
Amylopectin、General Diagonostics社（米国）
製）の有色試薬を実施例１と同様のメンブランフ
イルターに含浸して乾燥させたものをラミネート
により接着積層して多層一体型の血中アミラーゼ
化学分析材料を作成した。これは試薬層と展開層
が合体された型のものであつた。Example 3 Multi-layer integrated blood analysis material for amylase quantification using colored reagents On the same PET film as in Example 1, 3 g of gelatin and 2 g of mordant (styrene and N,N-dimethyl-N- (3-maleimidopropyl) copolymer with ammonium chloride) was provided by coating. Example 1
A color shielding layer containing aluminum foil-like fine powder having a thickness of 20 μm after drying was provided by the same operation as above. Furthermore, a dye-bound amylopectin solution (Reacton Red 2B) was added as a substrate for the amylase enzyme.
Amylopectin, General Diagonostics (USA)
A membrane filter similar to that used in Example 1 was impregnated with a colored reagent (manufactured by Kawasaki Co., Ltd.) and dried, and the membrane filters were laminated with adhesive to form a multilayer integrated blood amylase chemical analysis material. This was a type in which a reagent layer and a developing layer were combined.
このものは、PETフイルム側から観察した
所、完全に有色試薬の色が隠蔽されたものである
が、アミラーゼ標準液でテストした所、標準液滴
下部分の検出層のみに色素が受容されてPETフ
イルム側から比色をすることができた。 When observed from the PET film side, the color of the colored reagent was completely hidden, but when tested with an amylase standard solution, the dye was accepted only in the detection layer where the standard solution was dropped, and the PET film showed that the color of the colored reagent was completely hidden. I was able to compare colors from the film side.
かくの如く、本発明の金属粉末を含む水浸透性
の色遮蔽層は、従来公知の色遮蔽層の約10分の１
の厚さで十分に色を隠蔽する効果があり、そのた
めに多層一体型の血液化学分析材料全体の厚さを
減ずることができ、材料の製造上及び化学分析性
能上の効果の改善の度合いが大きいことが明らか
になつた。 As described above, the water-permeable color shielding layer containing the metal powder of the present invention has a water-permeable color shielding layer that is approximately one-tenth that of conventionally known color shielding layers.
It has a sufficient color hiding effect with a thickness of It became clear that something big was going on.
図面は本発明の色遮蔽層が多孔性展開層、試薬
層と共に配置された多層一体型の血液化学分析材
料を模型的に図示したもの、ならびに本発明と従
来公知の血液化学分析材料を用い、全血試料を用
いて血液中のグルコースの定量を行なつた検量線
である。第１図は単数試薬層を有する血液化学分
析材料を、第２図は複数試薬層を有する血液化学
分析材料をそれぞれ示す。第３図は血液中のグル
コース量についての検量線である。
１：色遮蔽層、２：多孔性展開層、３：試薬
層、４：試薬層、５：支持体、矢印Ａ：試料を滴
下する方向、矢印Ｂ：観察・測定（比色定量）す
る方向、直線：本発明の材料を用いた検量線、
破線Ｐ：従来技術の材料を用いた検量線。
The drawings schematically illustrate a multilayer integrated blood chemistry analysis material in which the color-shielding layer of the present invention is arranged together with a porous development layer and a reagent layer, and a blood chemistry analysis material using the present invention and a conventionally known blood chemistry analysis material. This is a calibration curve for quantifying glucose in blood using whole blood samples. FIG. 1 shows a blood chemistry analysis material having a single reagent layer, and FIG. 2 shows a blood chemistry analysis material having multiple reagent layers. FIG. 3 is a calibration curve for the amount of glucose in blood. 1: Color shielding layer, 2: Porous development layer, 3: Reagent layer, 4: Reagent layer, 5: Support, Arrow A: Direction of dropping the sample, Arrow B: Direction of observation/measurement (colorimetric determination) , straight line: calibration curve using the material of the present invention,
Broken line P: Calibration curve using conventional material.
Claims (1)
む多層一体型の血液化学分析材料において、金属
粉末を含む水浸透性の色遮蔽層を有することを特
徴とする多層一体型の血液化学分析材料。 ２ 該三層を有する多層一体型の血液化学分析材
料を支持しうる支持体を有する特許請求の範囲１
に記載の多層一体型の血液化学分析材料。[Scope of Claims] 1. A multi-layer integrated blood chemistry analysis material comprising a combination of a porous spreading layer and a reagent layer, characterized by having a water-permeable color-shielding layer containing metal powder. Body type blood chemistry analysis material. 2 Claim 1 having a support capable of supporting the multilayer integrated blood chemistry analysis material having the three layers
A multilayer integrated blood chemistry analysis material described in .
Priority Applications (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP9890278A JPS5526429A (en) | 1978-08-14 | 1978-08-14 | Multi-layer incorporating type blood chemical analysis material |
| DE19792932973 DE2932973A1 (en) | 1978-08-14 | 1979-08-14 | INTEGRAL MULTILAYERED MATERIAL FOR CHEMICAL ANALYSIS OF BLOOD |
| US06/066,363 US4255384A (en) | 1978-08-14 | 1979-08-14 | Multilayered integral element for the chemical analysis of the blood |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP9890278A JPS5526429A (en) | 1978-08-14 | 1978-08-14 | Multi-layer incorporating type blood chemical analysis material |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPS5526429A JPS5526429A (en) | 1980-02-25 |
| JPS6122906B2 true JPS6122906B2 (en) | 1986-06-03 |
Family
ID=14232052
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP9890278A Granted JPS5526429A (en) | 1978-08-14 | 1978-08-14 | Multi-layer incorporating type blood chemical analysis material |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPS5526429A (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2145683A1 (en) * | 2008-07-14 | 2010-01-20 | F.Hoffmann-La Roche Ag | Analytic test element with hydrophilic modified surface |
-
1978
- 1978-08-14 JP JP9890278A patent/JPS5526429A/en active Granted
Also Published As
| Publication number | Publication date |
|---|---|
| JPS5526429A (en) | 1980-02-25 |
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