TW581868B - Visual blood glucose test strip - Google Patents
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- TW581868B TW581868B TW088113842A TW88113842A TW581868B TW 581868 B TW581868 B TW 581868B TW 088113842 A TW088113842 A TW 088113842A TW 88113842 A TW88113842 A TW 88113842A TW 581868 B TW581868 B TW 581868B
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- G—PHYSICS
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- G01N31/00—Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods
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- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
- G01N33/521—Single-layer analytical elements
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- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/66—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood sugars, e.g. galactose
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- Y10T436/144444—Glucose
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Description
五、發明説明(2 ) 血液施加至表面經1分鐘後將其擦掉,比較測試條之 與代表特定葡萄糖濃度之色圖的顏色塊。 ^ 1971年12月28日頒佈給H. Rey et al·之美國專利 3,630,957號揭示-種塗覆試劑組成物之塑賴測試條, 使用方法與先别揭示之專利類似-施加血液,等待1分 鐘,比較所得的顏色與色圖。 71 1990年12月4日頒佈給Albarella et al.之美國專利 4,975,367號揭示-種配對顏色之測試條,其設計是經由 使用兩個獨立的指示料統,在不同的分析物濃度下提 供不同的色彩,其也揭示選用顏色阻滞齡延遲獨立系 統之催化效應,改變特定濃度之分析物產生的最線色 彩。 、 1993年4月6日頒佈給J M· Blatt et al·之美國專利 5,200,325號揭示一種”自動指示,,之測試條,其中不需要 色圖比較,在指示劑反應前經由進行扣除反液使測試條 指示分析物是否存在預先決定之濃度值,因此只有當分 析物存在為預先測定之濃度或更高時,測試條才產生預 先決定之回應。 上述討論之專利牽涉,,擦拭”測試條,經由從測試條 表面擦除過量的血液樣品,使全血顏色與指示劑染料產 生的顏色之間的干擾最小化,替代方式是將血液樣品施 加至測試條的一面,並在另一表面上測量顏色,下列討 論之專利為其實例。 發明説明(5 爛萄糖遭度無關, 其目的是加強兩個膜顏 血液是不需要擦拭,可使用少量的 簡要說明 圖1為本發明測試條之頂面圖。 圖2為圖1的測試條之底面圖。 圖為本發明測試條另一個具體實施例之分解透視 圖4為本發明測試條再一個具體實施例之分解透視 圖 經濟部智慧財產局員工消費合作社印製 圖。 本㈣频實施酬4_雜值對使用 心準儀表測I的值作圖之散佈圖。 登jg之詳細說明 、本,明提供不需要擦拭之血軸試條,其使用少量 血液樣ua且*需要制絲就可快 發明測試條部份剖面之頂面圖,且圖2為底面圖二2 不,測試條10有三個部份:擴散頂層12、含試劑之中間 層14及支撐層16,中間層14包括兩個相連的膜14a及 Hb,其可分別經由支撐層16上的開口丨如及丨你觀察,膜 14a 3 了與動萄糖反應造成目視顏色變化之試劑,膜 也含可與葡萄糖反應造成顏色變化之試劑,但是形成的 顏色與在膜14a形成的顏色不同(如下文之討論)。
581868 A7 B7 五、發明説明( 經濟部智慧財產局員工消費合作社印製 在操作血液樣品時,不需要大於約10微升,將其施 加至,散的頂層I2,當樣品穿透膜12後擴個來,所以 ,品實質上均勻地分布在膜14a及14b,血祕品中的葡 萄糖當朝向支撐層崎過時,與咖的試劑反應而形成 顏色。 如果支撐層16不是透明,顏色是經由選用的開 口 16a 及16b觀察,並與校正色獨比較以決定血糖濃度。 多種材料合適作為擴散層,例如紙、玻璃纖維、聚 合物、燒結的塑膠,織造及非織造纖維及膜,較佳的材 料必須具有最少的樣品量、快速吸收樣品、將其均勻分 佈至膜、且不會干擾膜内試劑之化學性,當然,成本也 疋一個考量點,供擴散層使用的一種較佳材料為可得自 Tetko, Inc·,Deprew,NY之親水性聚酯織造網,最少的樣 品量及快速吸收暗指一種薄層,但是與膜的良好接觸很 重要,如果層如此》專,其將谷易續摺而使接觸困難,商 業化供應的Tetko網7-280/44為商業化供應的網中較厚的 網(255微米),且不容易縐褶,Tetko網提供快速的吸收及 低的最少樣品量,但是其可能不具有吸收大量血液樣品 之谷里,(不欲地)將過剩的樣品留在擴散層之表面上。 另一種較佳的擴散層材料為熱燒結的塑膠,例如經 由使用與血液相容的表面活性劑前處理或後處理使其具 有親水性之聚乙烯或聚丙烯,一種此材料為使用牛續酸 甲基油醯酯鈉處理之多孔聚乙烯,其可得自p〇rexC〇rp Fairburn,Georgia,此材料之優點是具有異常強的吸收 (請先閲讀背面之注意事 .裝· 訂 8 本紙張尺度適用中國國家標準(CNS ) Α4規格(210X297公釐) 581868 五、發明説明(7 ) 性,使流體被從表面吸走,否則將會轉移至與其接觸之 物件或人,此材料之孔洞範圍從約2〇微米至約35〇微米, 較宜為50至約150微米,或平均為約1〇〇微米,合適的網 約0.5至0.6毫米厚,約5至6毫米寬及約3〇毫米長。 圖3敘述容許更大樣品量的測試條之分解圖,顯示的 測試條除了圖1及2所示的元件以外,還包括視需要選用 的覆蓋層18,含有穿孔20供施加樣品至擴散層。 圖4敘述本發明另一種測試條之分解圖,在該具體實 施例中,視需要選用並連接擴散層12之吸收層22供吸收 過量的樣品,當擴散層12為較厚的燒結聚乙烯型(p〇rex) 時,通常不需要使用吸收層22,但是當擴散層為織造網 型(Tetko)時,其有較低的流體容量,較宜存在吸收層 22 〇 視需要使用黏著劑將測試條之元件結合在一起,雙 面膠帶是一種方便使用的黏著劑,圖4之具體實施例包括 黏著劑層24 (含開口 24a及24b)結合支撐層16與中間層 14、黏著劑層26結合中間層14與擴散層12、及黏著劑層 28 (含開口28a)結合覆蓋層18與擴散層12及吸收層22,黏 著劑層26顯示與膜14a及14b相鄰,但是相對位置並不重 要,因此在膜與黏著劑層之間可有間隙或可稍微重疊。 最合適供本發明測試條使用的膜材料及試劑是可提 供快速的反應時間、使用最少量的樣品及產生均勻的顏 色、具有安定的終點,此外,血液顏色必須實質上從觀 察側隱藏,所以不會干擾測定,基於這些標準,較佳的 9 本紙張尺度適用中國國家標準(CNS ) Α4規格(210Χ297公釐). (請先閲讀背面之注意事 丨II裝— 本頁) 訂 經濟部智慧財產局員工消費合作社印製 581868 A7 B7 經濟部智慧財產局員工消費合作社印製 五、發明説明(8 ) 膜材料為不對稱的聚砜膜,其孔洞大小從一面往另一面 逐漸增大(見1986年12月16日頒佈給Wrasidlo之美國專利 4,629,563號),此種膜可得自 jyjemtec Div. of U. S· Filter Co” San Diego, CA,用i〇微升或更少量的樣品,在低於 45秒内,這些膜可提供均勻的顏色發展,膜從觀察側隱 藏血液顏色之能力決定於其孔洞的大小,大孔洞無法良 好地隱藏血液顏色,但是孔洞小於約0·10微米之膜在塗 上試劑後有裂開之傾向,設計供不對稱膜之孔洞大小為 較小的孔洞大小,較宜使用孔洞大小低於約i 〇微米之 膜,更宜約0.15至0.35微米,在血球容積範圍為30-55% 時,可提供可接受的血液隱藏性,此種膜包括Memtec膜 BTS 30、45、55及65,兩種膜14a及14b較宜為相同的材 料,通常需要10微升的血液使兩個測試墊片飽和,但是 也可吸收過量的血液,其體積由擴散層材料之孔隙及尺 寸決定。 摻混在兩種膜内的試劑組成物與血液樣品中的葡萄 糖反應,造成可偵測到的顏色變化,合適的組成物揭示 在上述專利4,935,346及5,563,031號,這些專利併於本文 供參考,通常這些組成物含將葡讀糖轉化成過氧化氫之 成份例如葡萄糖氧化酶,及偵測從存在於樣品中的葡萄 糖產生的過氧化氫之一或多種成份,偵測過氧化氳的成 份可為過氧化酶,較宜為嫜菜過氧化酶,以及在反應過 程中變色之”指示劑”,指示劑可為可氧化的染料或染料 對,過氧化酶在過氧化氫存在下催化指示劑之氧化反 10 本紙張尺度適用中國國家榡準(CNS ) A4規格(210X297公釐) (請先閲讀背面之注意事_ ▼本頁) 裝. 訂 • HI m 581868 經濟部智慧財產局員工消費合作社印製 A7 ____ B7 五、發明説明(9 ) 應,指不劑可為3-甲基-2-苯並噻唑咁_宗鹽酸鹽結舍3,3_ 二甲胺基苯甲酸(MBTH_DMAB)或8-苯胺基萘磺酸銨 (MBTH-ANS),或者是指示劑可為間[3_甲基苯並噻唑 咁酮腙]苯磺酸N-續醯自旨單鈉結合8_苯胺基-萘磺酸銨 (MBTHSB-ANS),以後者之組合較佳。 膜14b也含延遲顏色形成反應之抑制劑及染料,只含 顏色形成劑組成物之膜14a可分辨數種等級之低葡萄糖範 圍,例如25、50及80毫克/分升,對於更高的葡萄糖濃 度,顏色太深而無法在葡萄糖等級之間可信賴性地分 辨,在膜14b之顏色發展被抑制,所以決定於使用的抑制 劑濃度,可在較高的葡萄糖等級下開始顏色發展,合適 使用多種的抑制劑,包括2,3,4-三羥基苯甲酸、掊酸丙酯 及抗壞血酸(見上述美國專利5,3〇6,623號),以抗壞血酸較 佳,且較宜選擇抗壞血酸之濃度,使顏色發展延遲至葡 萄糖等級到達約120毫克/分升後。 包含一種產生不同顏色的含抑制劑之惰性染料,可 提供更佳的葡萄糖等級分辨,合適的惰性染料為黃媒染 劑、櫻草靈黃、普馬克(primaquine)二填酸酯、嗔嗤黃 G、亮黃及〇-無水金胺,經由改變染料種類及濃度,可 產生綠、黃、紫或藍的不同色澤,在0.1%濃度之〇_無水 金胺較佳,因為與MBTHSB-ANS結合時,其可提供鮮綠 色,在葡萄糖等級中有最大的目視解析度及極佳的塗覆 均勻性,在此組合下,在膜14a及14b内的較佳試劑組成 (請先閲讀背面之注意事本頁)
• —·i- I- - · 裝· -訂 11 本紙張尺度適用f關家榡準(CNS ) A4規格(2lQx297公廣) 581868
五 物可讓使用者在從25至_毫克/分升之葡萄糖濃度範圍 内分辨八個等級。 為了更加強賴血液的效應,以及因而容許測量更 寬範圍之樣品血球容積,在試射可添加多種水溶性聚 合物,包括聚乙烯吡咯酮(PVP)、GAFQUAT*、聚丙烯酸 及聚苯乙烯石黃酸,經驗上以PVP較佳。 下列實例說明在不同具體實施例下的本發明,但是 不能以任何方式作為其限制。 實例1 使用孔洞大小為0.2微米之親水性不對稱聚砜膜 (MemtecBTS-55)製備試劑測試條,·使鈍面(較大的孔洞大 小)與溶液1接觸而塗覆膜(吻塗),用玻璃棒塗抹膜面將過 ϊ的溶液去除,在56°C之加壓空氣爐内將膜空氣乾燥10 分鐘。 塗料組成物為: (請先閲讀背面之注意事 巧本頁) •裝· 訂 經濟部智慧財產局員工消費合作社印製 溶液1 水 25 毫升 擰檬酸 0.282 克 捧樣酸三納 0.348 克 甘露醇 0.25 克 EDTA 0.021 克 Gantrez 0.1125 克 Crotein 0.36 克 葡萄糖氧化酶 0.36 克(125單位/毫克) 12
本紙張尺度適用中國國家榡準(⑽)八视2獻297公董 581868
肆菜過氧化物 0.071 Carbopol溶液* ι 25 克(501單位/毫克) 毫升 (0.1375克於1.25宅升1^〇|^中) 檸檬酸鹽緩衝液* 3.75 * (〇·13克檸檬酸二鈉於5 〇毫升水中) 對於低範圍的膜(14a),將塗履溶液ι之膜吻塗染料溶 液2並在相同於上述之爐中乾燥5分鐘。 染料溶液2組成物為: 毫升 (請先閲讀背面之注意‘ 事 溶液2 溶劑* 38.16 毫升 MBTHSB 0.1552 克 ANS 0.2142 克 20% Maphos (溶劑)1.84 克 (* 溶劑:50%水、30%EtOH及20%MeOH) 對於局範圍的膜(14b),將塗覆溶液1之膜吻塗染料溶 液3並在相同於上述之爐中乾燥5分鐘。 染料溶液組成物為: 本頁} -裝-
、1T
經濟部智慧財產局員工消費合作社印製 溶液3 溶劑* 38.16 毫升 MBTHSB 0.1552 克 ANS 0.2142 克 20%Maphos (溶劑)1.84 克 金胺0 0.0316 克 抗壞血酸 0.13 克 13 本紙張尺度適用中國國家標準(CNS ) A4規格(210 X 297公釐) 581868 經濟部智慧財產局員工消費合作社印製 A7 ______ B7 五、發明説明(12 ) (* 溶劑:50%水、30%EtOH及20%MeOH) 所得膜經切成寬0.6公分之長條並用以依圖丨及2所述製成 試條。 經由目視比較Munsell色片所建構且校準至葡萄糖值 範圍0-600毫克/公合之色圖(表1)來測試試條。隨機測 試288個經刺傷取出之靜脈血樣本與使用標準血糖儀(Yellow Springs Instmments (YSI) Model 2300 STAT 葡萄糖 分析儀,校正血漿葡萄糖值)所取得之測定值間有優異 之關連性(圖5) 實例2 根據實例1之步驟,但是將溶液1及2 (或3)塗覆在膜 的小孔側並在染料溶液塗層上加上隱藏血液的聚合物塗 層,測試數種不同的聚合物,各下列聚合物之水溶液可 有效地隱藏血液顏色: 聚乙烯基吡咯酮—分子量16〇,〇〇〇,2% GAFQUAT 734 (四級化的乙烯基吡咯酮與甲基丙稀 酸二甲胺基乙酯之共聚物)-分子量6〇,〇〇〇-1〇〇,〇〇〇,7% 聚苯乙烯磺酸之鈉鹽-分子量7〇,〇〇〇,7% 表 1 Munsell Notation* 色圖·_ 葡萄糖等級 墊片#1 塾片#2 (毫克/分升) 0 10 P 7/2 10 YR 7/6 (請先閱讀背面之注意事 -本頁) -裝 訂 14 巧張尺度適财關家縣(CNS ) A4· ( 210X297公釐) 581868 A7 B7 五、發明説明(13 ) 25 5 PB 6/2 2.5 Y 6/8 50 10 B 6/4 2.5 Y 6/8 80 10 B 5/4 2.5 Y 6/8 120 2.5 PB 5/6 7.5 Y 6/6 180 2.5 PB 4/8 5 GY 5/6 240 5 PB 4/8 10 GY 5/6 400 7.5 PB 3/10 5 G 4/6 500 5 PB 3/8 10 G 3/4 (請先閲讀背面之注意事_
* tThe Munsell Book of Color,Macbeth div. of Kollmorgen Instruments Corp., New Windsor, NY 本I) -裝· 、1Τ 經濟部智慧財產局員工消費合作社印製 本紙張尺度適用中國國家標準(CNS ) A4規格(210X297公釐)
Claims (1)
- A8 B8 C8 D8 經濟部中央標準局員工消費合作社印製 58186S 六、申請專利範圍 專利申請案第88113842號 ROC Patent Appln. No. 88113842 修正之申請專利範圍中文本-附件(一) Amended Claims in Chinese - EncL (I) (民國90年11月23曰送呈) (Submitted on November 23 , 2001) 1. 一種可目視判讀之血糖測試條,包括 a) 在第一側上接收血液樣品並使樣品穿透至反面 的第二側之雙側擴散層, b) 含實質上相鄰的第一個及第二個膜之中間層, 各膜含與擴散層第二個主要表面連接之上主要 表面以接收一部份的血液樣品且各含可與穿透 膜的樣品中的葡萄糖反應而使試劑變色之試 劑,第二個膜還含抑制劑及染料,及 c) 支撐其他層並可經由其目視膜顏色變化之支撐 層。 2. 根據申請專利範圍第1項之測試條,其中擴散層含 親水性的聚酯織造纖維。 3. 根據申請專利範圍第1項之測試條,其中擴散層含 燒結的聚乙烯。 4. 根據申請專利範圍第1項之測試條,其中中間層之 各膜為不對稱的聚砜膜。 5. 根據申請專利範圍第1項之測試條,其中在各膜内 的試劑相同。 6. 根據申請專利範圍第5項之測試條,其中該試劑含 3-曱基-2-苯並噻唑咁酮腙鹽酸鹽結合3,3-二甲胺基 本紙張尺度適用中國國家標準(CNS ) A4規格(210X297公釐) (請先閲讀背面之注意事項再填寫本頁) p 、言 581868 A8 B8 C8 D8 夂、申請專利範圍 笨甲酸(MBTH-DMAB)。 、 7·根據申請專利範圍第5項之測試條,其中該試劑含 3·甲基-2-苯並噻唑咁酮腙鹽酸鹽結合8-苯胺基-1-蒸磺酸銨(MBTH-ANS)。 8·根據申請專利範圍第5項之測試條,其中該試劑含 間[3-曱基-2-苯並噻唑咁酮腙]N-磺醯基苯磺酸單鈉 鹽結合8-苯胺基_1_萘磺酸銨(MBTHSB-ANS)。 9·根據申請專利範圍第5項之測試條,其中該試劑還 含可溶性聚合物。 1〇·根據申請專利範圍第9項之測試條,其中該可溶性 聚合物為聚乙烯基吡咯酮。 U·根據申請專利範圍第1項之測試條,其中該抑制劑 含抗壞血酸。 12·根據申請專利範圍帛i項之測試條,其中該染料含 無水金胺。 13. 根據巾請專利範圍第i項之職條,其中經由支樓 層上的孔洞可以目視看到臈的任何顏色變化。 14. 根據巾請專利範圍第1項之測試條,其在支撐層上 ,包括-個覆蓋層覆蓋層上含有穿孔供施加樣品至 擴散層。 15:申請專利範圍第1項之測試條,其還含鄰接擴 月欠層之吸收層供吸收過量之樣品。 、 --------^ ---— II--- (請先閱讀背面之注意事項再填寫本頁) -17 .
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