WO2024108892A1 - 一种检测***物隐血的组合物及其制备方法和应用 - Google Patents

一种检测***物隐血的组合物及其制备方法和应用 Download PDF

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WO2024108892A1
WO2024108892A1 PCT/CN2023/090486 CN2023090486W WO2024108892A1 WO 2024108892 A1 WO2024108892 A1 WO 2024108892A1 CN 2023090486 W CN2023090486 W CN 2023090486W WO 2024108892 A1 WO2024108892 A1 WO 2024108892A1
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parts
peroxide
composition
starch
combination
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PCT/CN2023/090486
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English (en)
French (fr)
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王曦
郭维学
任平俊
肖菲
吴赛
李敏
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上海佩格医院管理有限公司
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Publication of WO2024108892A1 publication Critical patent/WO2024108892A1/zh

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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N21/78Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour

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  • the present application belongs to the field of disease detection, and specifically relates to a composition for detecting occult blood in feces, a preparation method and an application thereof, and especially relates to a composition for detecting occult blood in feces with high sensitivity, a preparation method and an application thereof.
  • Blood in excrement is a common pathological symptom.
  • Possible causes of blood in stool include but are not limited to: hemorrhoids, ulcerative colitis, upper gastrointestinal bleeding, lower gastrointestinal bleeding, blood system diseases, anal fissures, gastrointestinal tumors, etc.; possible causes of blood in urine include but are not limited to: urinary system mucosal damage, urinary system stones, nephritis, urinary system tumors, etc.
  • CN114354948A discloses a semi-quantitative method for detecting fecal occult blood, and the steps of the semi-quantitative method for detecting fecal occult blood are as follows: the diluted sample is dripped into the spotting hole on the colloidal gold detection card through a spotting device, and after the qualitative negative and positive are initially displayed, a photo is taken and the qualitative result on the display is read by the reading instrument; after reading the qualitative result, a certain amount of 3,3,5,5-tetramethylbenzidine indicator solution is first dripped into the same spotting hole, and then a certain amount of hydrogen peroxide solution is dripped; after a period of reaction time after dripping the 3,3,5,5-tetramethylbenzidine indicator solution and the hydrogen peroxide solution, the colloidal gold detection card will show the semi-quantitative result, and the semi-quantitative result is read again by taking a photo.
  • the invention increases the semi-quantitative result of fecal occult blood detection, reduces manual operation, and reduces manual workload, thereby solving the defects of fecal occult blood detection in clinical examinations, and greatly reducing Reduce manual re-inspection work and ensure the accuracy of test results.
  • CN103175965A discloses a fecal occult blood detection kit, including a fecal occult blood detection test strip or test card, a sample processing tube or stool mixer and a sampling stick, wherein the test strip or test card includes a detection area (T) coated with anti-Hb1 monoclonal antibody and a quality control area (C) coated with goat anti-mouse polyclonal antibody and colloidal gold coated with anti-Hb2 monoclonal antibody.
  • the preparation method of the kit includes the steps of preparing a treatment liquid, preparing a kit, preparing a colloidal gold complex, spraying gold, cutting, assembling, cutting, packaging and the like.
  • the fecal occult blood detection kit has good specificity, high sensitivity, fast and simple detection, and is not restricted by diet and drugs.
  • the present application provides a composition for detecting occult blood in excreta, a preparation method and application thereof, and in particular provides a composition for detecting occult blood in excreta with high sensitivity, a preparation method and application thereof.
  • the composition provided in the present application can quickly and effectively detect occult blood in excreta, has a fast color change speed, a long color retention time and high sensitivity.
  • an embodiment of the present application provides a composition for detecting occult blood in feces, wherein the composition comprises, by weight, 20-80 parts of an organic solvent, 0.01-50 parts of a thickener, 0.01-2 parts of benzidine, 0.01-5 parts of a peroxide, 0.001-0.5 parts of EDTA-2Na and 10-80 parts of water.
  • the amount of organic solvent can be 20 parts, 30 parts, 40 parts, 50 parts, 60 parts, 70 parts or 80 parts
  • the amount of thickener can be 0.01 parts, 0.1 parts, 0.5 parts, 1 parts, 5 parts, 10 parts, 15 parts, 20 parts, 25 parts, 30 parts, 35 parts, 40 parts, 45 parts or 50 parts
  • the amount of benzidine can be
  • the number of parts of water can be 10 parts, 20 parts, 30 parts, 40 parts, 50 parts, 60 parts, 70 parts or 80 parts, but are not limited to the above-listed values. Other unlisted values within the above-listed numerical ranges are equally applicable.
  • the composition can effectively detect the occult blood in excrement by selecting specific components, with fast color change speed, long color retention time and high sensitivity.
  • the composition includes, by weight, 40-60 parts of an organic solvent, 10-40 parts of a thickener, 0.5-1.5 parts of benzidine, 1-4 parts of a peroxide, 0.1-0.3 parts of EDTA-2Na and 30-60 parts of water.
  • the organic solvent includes any one of ethanol, benzene, toluene, pentane, hexane, methanol, ether, ethyl acetate, acetone or carbon tetrachloride, or a combination of at least two thereof, such as a combination of ethanol and acetone, a combination of ethanol and toluene, or a combination of methanol and ethanol, but is not limited to the combinations listed above. Other combinations not listed within the above combination range are also applicable.
  • the organic solvent comprises a combination of ethanol and acetone.
  • the thickener includes any one of xanthan gum, guar gum, pectin, sodium polyacrylate, hydroxypropyl methylcellulose, sodium hydroxymethylcellulose or hydroxymethylcellulose, or a combination of at least two thereof, such as a combination of xanthan gum and guar gum, a combination of guar gum and pectin, or a combination of pectin and sodium polyacrylate, but is not limited to the combinations listed above, and other combinations not listed within the above combination range are also applicable.
  • the benzidine comprises any one of 4,4'-diaminobiphenyl, tetramethylbenzidine or 3,3'-dihydroxybenzidine or a combination of at least two thereof, for example, 4,4'-diaminobiphenyl and tetramethylbenzidine.
  • the benzidine includes a combination of 3,3'-dihydroxybenzidine and tetramethylbenzidine.
  • the combination of the above-mentioned specific benzidines can further improve the technical effect of the composition, accelerate the color change speed, prolong the color retention time, and further improve the detection sensitivity.
  • the peroxide includes an inorganic peroxide and/or an organic peroxide.
  • the peroxide comprises a combination of an inorganic peroxide and an organic peroxide.
  • the inorganic peroxide includes any one of hydrogen peroxide, sodium percarbonate, potassium peroxide, calcium peroxide or barium peroxide, or a combination of at least two thereof, such as a combination of hydrogen peroxide and sodium percarbonate, a combination of sodium percarbonate and potassium peroxide, or a combination of potassium peroxide and calcium peroxide, but is not limited to the combinations listed above, and other combinations not listed within the above combination range are also applicable.
  • the inorganic peroxide comprises hydrogen peroxide.
  • the organic peroxide includes any one of cumene hydroperoxide, diisopropylbenzene hydroperoxide, tert-amyl peroxyethyl ester or tert-butyl peroxyethyl ester, or a combination of at least two thereof, such as a combination of cumene hydroperoxide and diisopropylbenzene hydroperoxide, a combination of diisopropylbenzene hydroperoxide and tert-amyl peroxyethyl ester, or a combination of tert-amyl peroxyethyl ester and tert-butyl peroxyethyl ester, but is not limited to the above-listed combinations, and other combinations not listed within the above-listed combination range are equally applicable.
  • the organic peroxide comprises cumene hydroperoxide.
  • the composition further comprises 0.01-5 parts by weight of a pH adjuster.
  • a pH adjuster 0.01 parts, 0.1 parts, 0.5 parts, 1 parts, 1.5 parts, 2 parts, 2.5 parts, 3 parts, 3.5 parts, 4 parts, 4.5 parts or 5 parts, but not limited to the values listed above, other values not listed within the above numerical range are also applicable.
  • the pH adjuster includes any one of citric acid, acetic acid, sodium hydroxide or hydrochloric acid.
  • the composition further includes 1-80 parts of starch by weight, such as 1 part, 10 parts, 20 parts, 30 parts, 40 parts, 50 parts, 60 parts, 70 parts or 80 parts, but is not limited to the values listed above, and other unlisted values within the above numerical range are also applicable.
  • the starch includes any one of corn starch, pea starch, mung bean starch, gelatinized starch, hydroxymethyl starch, cross-linked starch, maltodextrin, oxidized starch, esterified starch or etherified starch, or a combination of at least two thereof, such as a combination of corn starch and pea starch, a combination of pea starch and mung bean starch, or a combination of mung bean starch and gelatinized starch, but is not limited to the above-listed combinations, and other combinations not listed within the above-listed combination range are also applicable.
  • the starch can be added according to the user's requirements to make the composition from liquid to solid, which is suitable for different scenarios.
  • the present invention provides a method for preparing the composition for detecting occult blood in feces as described above, the preparation method comprising the following steps:
  • the step (2) of mixing the thickener, EDTA-2Na and water to obtain the aqueous phase further comprises mixing with a pH adjuster.
  • the mixing of the aqueous phase and the organic phase in step (3) further comprises mixing with starch.
  • the embodiments of the present application also provide the use of the composition for detecting occult blood in feces as described above in the preparation of an occult blood detection device.
  • the occult blood detection device includes any one of a test strip, a test plate, a test kit or a test tube.
  • the present application provides a composition for detecting occult blood in excrement, which can effectively detect occult blood in excrement by selecting specific benzidine and peroxide, has fast color change speed, long color retention time and high sensitivity.
  • This embodiment provides a composition for detecting occult blood in feces, and the raw materials for preparation are as follows (in parts by weight):
  • the preparation method is as follows:
  • This embodiment provides a composition for detecting occult blood in feces, and the raw materials for preparation are as follows (in parts by weight):
  • the preparation method is similar to that of Example 1.
  • This embodiment provides a composition for detecting occult blood in feces, and the raw materials for preparation are as follows (in parts by weight):
  • the preparation method is similar to that of Example 1.
  • This embodiment provides a composition for detecting occult blood in feces, and the raw materials for preparation are as follows (in parts by weight):
  • the preparation method is similar to that of Example 1.
  • This embodiment provides a composition for detecting occult blood in feces, and the raw materials for preparation are as follows (in parts by weight):
  • the preparation method is similar to that of Example 1.
  • This embodiment provides a composition for detecting occult blood in feces.
  • the preparation raw materials are consistent with those of embodiment 1 except that 3,3'-dihydroxybenzidine is not added and a portion allocated to tetramethylbenzidine is reduced.
  • the preparation method is similar to that of Example 1.
  • This embodiment provides a composition for detecting occult blood in feces.
  • the preparation raw materials are consistent with those of embodiment 1 except that tetramethylbenzidine is not added and a portion allocated to 3,3'-dihydroxybenzidine is reduced.
  • the preparation method is similar to that of Example 1.
  • This embodiment provides a composition for detecting occult blood in feces.
  • the preparation raw materials are the same as those in Example 1 except that 3,3'-dihydroxybenzidine is replaced by an equal amount of 4,4'-diaminobiphenyl.
  • the preparation method is similar to that of Example 1.
  • This embodiment provides a composition for detecting occult blood in feces.
  • the preparation raw materials are consistent with those of embodiment 1 except that hydrogen peroxide is not added and the portion allocated to cumene hydrogen peroxide is reduced.
  • the preparation method is similar to that of Example 1.
  • This embodiment provides a composition for detecting occult blood in feces.
  • the preparation raw materials are consistent with those of embodiment 1 except that cumene hydroperoxide is not added and the portion allocated to hydrogen peroxide is reduced.
  • the preparation method is similar to that of Example 1.
  • This embodiment provides a composition for detecting occult blood in excrement.
  • the raw materials for preparing the composition include hydrogen peroxide. Except for replacing with an equal amount of sodium percarbonate, the rest is consistent with Example 1.
  • the preparation method is similar to that of Example 1.
  • This embodiment provides a composition for detecting occult blood in feces.
  • the preparation raw materials are the same as those in Example 1 except that cumene hydroperoxide is replaced by an equal amount of tert-butyl peroxyethyl octanoate.
  • the preparation method is similar to that of Example 1.
  • This embodiment provides a composition for detecting occult blood in feces.
  • the preparation raw materials do not contain ethanol and a reduced portion is allocated to acetone, and the rest is consistent with Example 1.
  • the preparation method is similar to that of Example 1.
  • This embodiment provides a composition for detecting occult blood in feces.
  • the preparation raw materials do not contain acetone and a reduced portion is allocated to ethanol. The rest is consistent with Example 1.
  • the preparation method is similar to that of Example 1.
  • This embodiment provides a composition for detecting occult blood in feces.
  • the preparation raw materials do not contain ethanol and a reduced portion is allocated to toluene, and the rest is consistent with Example 1.
  • the preparation method is similar to that of Example 1.
  • compositions for detecting occult blood in feces provided in Examples 1-15 were soaked in test papers respectively, and then dried to obtain test papers. Then, samples (normal human fresh blood diluted 10,000 times with water) were tested, and the color change time and color retention time were recorded.
  • samples normal human fresh blood diluted 10,000 times with water
  • the product provided by the present application has the advantages of short color change time and long color retention time, and can quickly detect samples; by comparing Examples 1-5, it can be found that the present application can effectively improve the effect of the product by controlling the amount of each raw material; by comparing Examples 1, 6-8, it can be found that the present application can effectively shorten the color change time and prolong the color retention time by selecting a specific combination of benzidine; by comparing Examples 1, 9-12, it can be found that the present application can effectively shorten the color change time and prolong the color retention time by selecting a specific peroxide and its combination; by comparing Examples 1, 13-15, it can be found that the present application By selecting a specific combination of organic solvents, the application can effectively shorten the color change time and extend the color retention time.
  • test strips were used to test samples with different hemoglobin concentrations, and the detection limits of the test strips were analyzed.
  • the results are as follows:
  • composition provided by the present application has the characteristics of high sensitivity and can effectively detect extremely low levels of hemoglobin; by comparing Examples 1-5, it can be found that the present application controls the raw materials The dosage can effectively improve the effect of the product; by comparing Examples 1, 6-8, it can be found that the present application can effectively reduce the detection limit and improve the detection sensitivity by selecting a specific combination of benzidine; by comparing Examples 1, 9-12, it can be found that the present application can effectively reduce the detection limit and improve the detection sensitivity by selecting a specific peroxide and a combination thereof; by comparing Examples 1, 13-15, it can be found that the present application can effectively reduce the detection limit and improve the detection sensitivity by selecting a specific combination of organic solvents.
  • the present application uses the above-mentioned embodiments to illustrate the composition for detecting fecal occult blood, its preparation method and application, but the present application is not limited to the above-mentioned embodiments, that is, it does not mean that the present application must rely on the above-mentioned embodiments to be implemented.
  • the technicians in the relevant technical field should understand that any improvement to the present application, the equivalent replacement of the raw materials of the product of the present application, the addition of auxiliary components, the selection of specific methods, etc., all fall within the protection scope and disclosure scope of the present application.

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Abstract

本申请提供了一种检测***物隐血的组合物及其制备方法和应用,所述组合物以重量份数计包括有机溶剂20-80份、增稠剂0.01-50份、联苯胺0.01-2份、过氧化物0.01-5份、EDTA-2Na 0.001-0.5份和水10-80份。本申请提供的组合物能够快速有效地检测***物的隐血情况,变色速度快,颜色保留时间长,灵敏度高。

Description

一种检测***物隐血的组合物及其制备方法和应用 技术领域
本申请属于疾病检测领域,具体涉及一种检测***物隐血的组合物及其制备方法和应用,尤其涉及一种灵敏度高的检测***物隐血的组合物及其制备方法和应用。
背景技术
***物中带血是一种常见的病理症状。可能造成粪便中带血的原因包括但不限于:痔疮、溃疡性结肠炎、上消化道出血、下消化道出血、血液***疾病、肛裂、消化道肿瘤等;可能造成尿液中带血的原因包括但不限于:泌尿***黏膜损伤,泌尿***结石、肾炎、泌尿***肿瘤等。以上病症造成的消化***和泌尿***出血包括两种情况:可见血液与隐血。***物中肉眼可见的血液较容易引起注意,但大部分疾病初期症状为***物隐血。而当***物中有可见血液时,病症可能已经较为严重,所以定期隐血检测可以对泌尿***和消化***疾病起到早期筛查效果。
CN114354948A公开了一种粪便隐血检测半定量方法,所述粪便隐血检测半定量方法步骤为:将稀释好的样本通过点样装置滴加到胶体金检测卡上的点样孔中,在初步显现出定性的阴性和阳性后,拍照并读取仪器读取显示器上的定性结果;读取定性结果后在相同点样孔中先滴加一定量3,3,5,5-四甲基联苯胺指示溶液,再滴加一定量的过氧化氢溶液;滴加3,3,5,5-四甲基联苯胺指示溶液和过氧化氢溶液一段反应时间后,胶体金检测卡将显现半定量结果,并再次进行拍照读取半定量结果。该发明增加了便隐血检测的半定量结果,减少了人工操作,降低了人工工作量,从而解决了临床检验中便隐血检测的缺陷,极大减 少人工复检的工作,保证检测结果的准确性。
CN103175965A公开了一种大便隐血检测试剂盒,包括大便隐血检测试纸条或试纸卡、样品处理管或采便混合器和取样棒,所述试纸条或试纸卡包括包被有抗Hb1单克隆抗体的检测区(T)和包被有羊抗鼠多克隆抗体的质控区(C)及包被有抗Hb2单克隆抗体的胶体金。上述试剂盒的制备方法包括处理液的配置、试剂盒的制备、胶体金复合物的制备、喷金、切割、组装、切割、包装等步骤。该大便隐血检测试剂盒特异性好、灵敏度高、检测快速、简单,不受饮食及药物限制。
由于隐血检测可以对泌尿***和消化***疾病起到早期筛查效果。因此,如何提供一种检测方便、灵敏度高的隐血检测方法或试剂,成为了亟待解决的问题。
发明内容
针对相关技术的不足,本申请提供一种检测***物隐血的组合物及其制备方法和应用,尤其提供一种灵敏度高的检测***物隐血的组合物及其制备方法和应用。本申请提供的组合物能够快速有效地检测***物的隐血情况,变色速度快,颜色保留时间长,灵敏度高。
本申请采用以下技术方案:
第一方面,本申请实施例提供了一种检测***物隐血的组合物,所述组合物以重量份数计包括有机溶剂20-80份、增稠剂0.01-50份、联苯胺0.01-2份、过氧化物0.01-5份、EDTA-2Na 0.001-0.5份和水10-80份。
其中,有机溶剂的份数可以是20份、30份、40份、50份、60份、70份或80份等,增稠剂的份数可以是0.01份、0.1份、0.5份、1份、5份、10份、15份、20份、25份、30份、35份、40份、45份或50份等,联苯胺的份数可 以是0.01份、0.1份、0.5份、1份、1.5份或2份等,过氧化物的份数可以是0.01份、0.1份、0.5份、1份、1.5份、2份、2.5份、3份、3.5份、4份、4.5份或5份等,EDTA-2Na的份数可以是0.001份、0.01份、0.1份、0.2份、0.3份、0.4份或0.5份等,水的份数可以是10份、20份、30份、40份、50份、60份、70份或80份等,但不限于以上所列举的数值,上述数值范围内其他未列举的数值同样适用。
上述组合物通过选择特定成分,能够有效检测***物的隐血情况,变色速度快,颜色保留时间长,灵敏度高。
在一个实施例中,所述组合物以重量份数计包括有机溶剂40-60份、增稠剂10-40份、联苯胺0.5-1.5份、过氧化物1-4份、EDTA-2Na 0.1-0.3份和水30-60份。
在一个实施例中,所述有机溶剂包括乙醇、苯、甲苯、戊烷、己烷、甲醇、***、醋酸乙酯、丙酮或四氯化碳中任意一种或至少两种的组合,例如乙醇和丙酮的组合、乙醇和甲苯的组合或甲醇和乙醇的组合等,但不限于以上所列举的组合,上述组合范围内其他未列举的组合同样适用。
在一个实施例中,所述有机溶剂包括乙醇和丙酮的组合。
在一个实施例中,所述增稠剂包括黄原胶、瓜尔豆胶、果胶、聚丙烯酸钠、羟丙基甲基纤维素、羟甲基纤维素钠或羟甲基纤维素中任意一种或至少两种的组合,例如黄原胶和瓜尔豆胶的组合、瓜尔豆胶和果胶的组合或果胶和聚丙烯酸钠的组合等,但不限于以上所列举的组合,上述组合范围内其他未列举的组合同样适用。
在一个实施例中,所述联苯胺包括4,4’-二氨基联苯、四甲基联苯胺或3,3'-二羟基联苯胺中任意一种或至少两种的组合,例如4,4’-二氨基联苯和四甲基联 苯胺的组合、四甲基联苯胺和3,3'-二羟基联苯胺的组合或4,4’-二氨基联苯和3,3'-二羟基联苯胺的组合等,但不限于以上所列举的组合,上述组合范围内其他未列举的组合同样适用。
在一个实施例中,所述联苯胺包括3,3'-二羟基联苯胺和四甲基联苯胺的组合。
上述特定联苯胺的组合能够进一步提高组合物的技术效果,加快变色速度,延长颜色保留时间,进一步提高检测灵敏度。
在一个实施例中,所述过氧化物包括无机过氧化物和/或有机过氧化物。
在一个实施例中,所述过氧化物包括无机过氧化物和有机过氧化物的组合。
在一个实施例中,所述无机过氧化物包括过氧化氢、过氧碳酸钠、过氧化钾、过氧化钙或过氧化钡中任意一种或至少两种的组合,例如过氧化氢和过氧碳酸钠的组合、过氧碳酸钠和过氧化钾的组合或过氧化钾和过氧化钙的组合等,但不限于以上所列举的组合,上述组合范围内其他未列举的组合同样适用。
在一个实施例中,所述无机过氧化物包括过氧化氢。
在一个实施例中,所述有机过氧化物包括过氧化氢异丙苯、过氧化氢二异丙苯、过氧化异辛酸叔戊酯或过氧化异辛酸叔丁酯中任意一种或至少两种的组合,例如过氧化氢异丙苯和过氧化氢二异丙苯的组合、过氧化氢二异丙苯和过氧化异辛酸叔戊酯的组合或过氧化异辛酸叔戊酯和过氧化异辛酸叔丁酯的组合等,但不限于以上所列举的组合,上述组合范围内其他未列举的组合同样适用。
在一个实施例中,所述有机过氧化物包括过氧化氢异丙苯。
上述特定的过氧化物及其组合能够有效提高组合物的技术效果,加快变色速度,延长颜色保留时间,进一步提高检测灵敏度。
在一个实施例中,所述组合物以重量份数计还包括pH调节剂0.01-5份, 例如0.01份、0.1份、0.5份、1份、1.5份、2份、2.5份、3份、3.5份、4份、4.5份或5份等,但不限于以上所列举的数值,上述数值范围内其他未列举的数值同样适用。
在一个实施例中,所述pH调节剂包括柠檬酸、醋酸、氢氧化钠或盐酸中任意一种。
在一个实施例中,所述组合物以重量份数计还包括淀粉1-80份,例如1份、10份、20份、30份、40份、50份、60份、70份或80份等,但不限于以上所列举的数值,上述数值范围内其他未列举的数值同样适用。
在一个实施例中,所述淀粉包括玉米淀粉、豌豆淀粉、绿豆淀粉、糊化淀粉、羟甲基淀粉、交联淀粉、麦芽糊精、氧化淀粉、酯化淀粉或醚化淀粉中任意一种或至少两种的组合。例如玉米淀粉和豌豆淀粉的组合、豌豆淀粉和绿豆淀粉的组合或绿豆淀粉和糊化淀粉的组合等,但不限于以上所列举的组合,上述组合范围内其他未列举的组合同样适用。
上述淀粉可根据使用者的要求进行添加,将组合物由液体制成固体,适用于不同的场景。
第二方面,本申请实施例提供了如上所述的检测***物隐血的组合物的制备方法,所述制备方法包括以下步骤:
(1)将联苯胺、过氧化物与有机溶剂混合得到有机相;
(2)将增稠剂、EDTA-2Na和水混合得到水相;
(3)将水相和有机相混合,得到所述检测***物隐血的组合物;
步骤(1)、(2)不区分先后顺序。
在一个实施例中,步骤(2)所述将增稠剂、EDTA-2Na和水混合得到水相还包括与pH调节剂混合。
在一个实施例中,步骤(3)所述将水相和有机相混合还包括与淀粉混合。
第三方面,本申请实施例还提供了如上所述的检测***物隐血的组合物在制备隐血检测装置中的应用。
在一个实施例中,所述隐血检测装置包括检测试纸、检测板、试剂盒或检测管中任意一种。
与相关技术相比,本申请具有如下有益效果:
本申请提供了一种检测***物隐血的组合物,通过选择特定联苯胺和过氧化物,能够有效检测***物的隐血情况,变色速度快,颜色保留时间长,灵敏度高。
具体实施方式
为更进一步阐述本申请所采取的技术手段及其效果,以下结合本申请的可选实施例来进一步说明本申请的技术方案,但本申请并非局限在实施例范围内。
实施例1
本实施例提供了一种检测***物隐血的组合物,制备原料如下(以重量份数计):
乙醇30份、丙酮20份、黄原胶25份、3,3'-二羟基联苯胺0.5份、四甲基联苯胺0.5份、过氧化氢1份、过氧化氢异丙苯1份、EDTA-2Na 0.25份、水50份,柠檬酸2.5份。
制备方法如下:
(1)将乙醇、3,3'-二羟基联苯胺、四甲基联苯胺、过氧化氢、过氧化氢异丙苯混合搅拌,得到有机相;
(2)将水、黄原胶、EDTA-2Na、柠檬酸混合得到水相。
(3)将水相和有机相混合搅拌,得到所述检测***物隐血的组合物。
实施例2
本实施例提供了一种检测***物隐血的组合物,制备原料如下(以重量份数计):
乙醇40份、果胶10份、四甲基联苯胺0.5份、过氧化氢异丙苯1份、EDTA-2Na 0.1份、水30份,柠檬酸0.1份。
制备方法参考实施例1。
实施例3
本实施例提供了一种检测***物隐血的组合物,制备原料如下(以重量份数计):
乙醇60份、瓜尔豆胶40份、4,4’-二氨基联苯1.5份、过氧化氢4份、EDTA-2Na 0.3份、水60份,柠檬酸5份。
制备方法参考实施例1。
实施例4
本实施例提供了一种检测***物隐血的组合物,制备原料如下(以重量份数计):
乙醇20份、果胶0.01份、四甲基联苯胺0.01份、过氧化氢异丙苯0.01份、EDTA-2Na 0.001份、水10份,柠檬酸0.1份。
制备方法参考实施例1。
实施例5
本实施例提供了一种检测***物隐血的组合物,制备原料如下(以重量份数计):
乙醇80份、瓜尔豆胶50份、4,4’-二氨基联苯2份、过氧化氢5份、EDTA-2Na0.5份、水80份,柠檬酸5份。
制备方法参考实施例1。
实施例6
本实施例提供了一种检测***物隐血的组合物,制备原料中除不添加3,3'-二羟基联苯胺,减少部分分配给四甲基联苯胺外,其余与实施例1一致。
制备方法参考实施例1。
实施例7
本实施例提供了一种检测***物隐血的组合物,制备原料中除不添加四甲基联苯胺,减少部分分配给3,3'-二羟基联苯胺外,其余与实施例1一致。
制备方法参考实施例1。
实施例8
本实施例提供了一种检测***物隐血的组合物,制备原料中除将3,3'-二羟基联苯胺替换为等量的4,4’-二氨基联苯外,其余与实施例1一致。
制备方法参考实施例1。
实施例9
本实施例提供了一种检测***物隐血的组合物,制备原料中除不添加过氧化氢,减少部分分配给过氧化氢异丙苯外,其余与实施例1一致。
制备方法参考实施例1。
实施例10
本实施例提供了一种检测***物隐血的组合物,制备原料中除不添加过氧化氢异丙苯,减少部分分配给过氧化氢外,其余与实施例1一致。
制备方法参考实施例1。
实施例11
本实施例提供了一种检测***物隐血的组合物,制备原料中除将过氧化氢 替换为等量的过氧碳酸钠外,其余与实施例1一致。
制备方法参考实施例1。
实施例12
本实施例提供了一种检测***物隐血的组合物,制备原料中除将过氧化氢异丙苯替换为等量的过氧化异辛酸叔丁酯外,其余与实施例1一致。
制备方法参考实施例1。
实施例13
本实施例提供了一种检测***物隐血的组合物,制备原料中除不包含乙醇,减少部分分配给丙酮外,其余与实施例1一致。
制备方法参考实施例1。
实施例14
本实施例提供了一种检测***物隐血的组合物,制备原料中除不包含丙酮,减少部分分配给乙醇外,其余与实施例1一致。
制备方法参考实施例1。
实施例15
本实施例提供了一种检测***物隐血的组合物,制备原料中除不包含乙醇,减少部分分配给甲苯外,其余与实施例1一致。
制备方法参考实施例1。
效果测试:
将实施例1-15提供的检测***物隐血的组合物分别用试纸浸润,之后干燥得到检测试纸,之后对样品(正常人体新鲜血液用水稀释10000倍)进行检测,记录变色时间以及颜色保留持时间,结果如下:
以上数据可以发现本申请提供的产品具有变色时间短,颜色保留时间长的优点,能够对样品进行快速检测;比较实施例1-5可以发现,本申请通过控制各原料的用量能够有效提高产品的效果;比较实施例1、6-8可以发现,本申请通过选择特定的联苯胺的组合,能够有效缩短变色时间,延长颜色保留时间;比较实施例1、9-12可以发现,本申请通过选择特定的过氧化物及其组合,能够有效缩短变色时间,延长颜色保留时间;比较实施例1、13-15可以发现,本 申请通过选择特定的有机溶剂组合,能够有效缩短变色时间,延长颜色保留时间。
之后将上述试纸分别检测不同血红蛋白浓度的待测样品,分析试纸的检出限,结果如下:
以上数据可以发现本申请提供的组合物具有灵敏度高的特点,能够有效检测出极低含量的血红蛋白;比较实施例1-5可以发现,本申请通过控制各原料 的用量能够有效提高产品的效果;比较实施例1、6-8可以发现,本申请通过选择特定的联苯胺的组合,能够有效降低检出限,提高检测灵敏度;比较实施例1、9-12可以发现,本申请通过选择特定的过氧化物及其组合,能够有效降低检出限,提高检测灵敏度;比较实施例1、13-15可以发现,本申请通过选择特定的有机溶剂组合,能够有效降低检出限,提高检测灵敏度。
申请人声明,本申请通过上述实施例来说明本申请的检测***物隐血的组合物及其制备方法和应用,但本申请并不局限于上述实施例,即不意味着本申请必须依赖上述实施例才能实施。所属技术领域的技术人员应该明了,对本申请的任何改进,对本申请产品各原料的等效替换及辅助成分的添加、具体方式的选择等,均落在本申请的保护范围和公开范围之内。
以上详细描述了本申请的可选实施方式,但是,本申请并不限于上述实施方式中的具体细节,在本申请的技术构思范围内,可以对本申请的技术方案进行多种简单变型,这些简单变型均属于本申请的保护范围。
另外需要说明的是,在上述具体实施方式中所描述的各个具体技术特征,在不矛盾的情况下,可以通过任何合适的方式进行组合,为了避免不必要的重复,本申请对各种可能的组合方式不再另行说明。

Claims (17)

  1. 一种检测***物隐血的组合物,所述组合物以重量份数计包括有机溶剂20-80份、增稠剂0.01-50份、联苯胺0.01-2份、过氧化物0.01-5份、EDTA-2Na 0.001-0.5份和水10-80份。
  2. 根据权利要求1所述的组合物,其中,所述组合物以重量份数计包括有机溶剂40-60份、增稠剂10-40份、联苯胺0.5-1.5份、过氧化物1-4份、EDTA-2Na 0.1-0.3份和水30-60份;
    所述有机溶剂包括乙醇、苯、甲苯、戊烷、己烷、甲醇、***、醋酸乙酯、丙酮或四氯化碳中任意一种或至少两种的组合。
  3. 根据权利要求1或2所述的组合物,其中,所述有机溶剂包括乙醇和丙酮的组合。
  4. 根据权利要求1-3任一项所述的组合物,其中,所述增稠剂包括黄原胶、瓜尔豆胶、果胶、聚丙烯酸钠、羟丙基甲基纤维素、羟甲基纤维素钠或羟甲基纤维素中任意一种或至少两种的组合。
  5. 根据权利要求1-4任一项所述的组合物,其中,所述联苯胺包括4,4’-二氨基联苯、四甲基联苯胺或3,3'-二羟基联苯胺中任意一种或至少两种的组合。
  6. 根据权利要求1-5任一项所述的组合物,其中,所述联苯胺包括3,3'-二羟基联苯胺和四甲基联苯胺的组合。
  7. 根据权利要求1-6任一项所述的组合物,其中,所述过氧化物包括无机过氧化物和/或有机过氧化物。
  8. 根据权利要求1-7任一项所述的组合物,其中,所述过氧化物包括无机过氧化物和有机过氧化物的组合。
  9. 根据权利要求7或8所述的组合物,其中,所述无机过氧化物包括过氧化氢、过氧碳酸钠、过氧化钾、过氧化钙或过氧化钡中任意一种或至少两种的 组合。
  10. 根据权利要求7-9任一项所述的组合物,其中,所述无机过氧化物包括过氧化氢。
  11. 根据权利要求7-9任一项所述的组合物,其中,所述有机过氧化物包括过氧化氢异丙苯、过氧化氢二异丙苯、过氧化异辛酸叔戊酯或过氧化异辛酸叔丁酯中任意一种或至少两种的组合。
  12. 根据权利要求7-9、11任一项所述的组合物,其中,所述有机过氧化物包括过氧化氢异丙苯。
  13. 根据权利要求1-12中任一项所述的组合物,其中,所述组合物以重量份数计还包括pH调节剂0.01-5份;
    可选地,所述pH调节剂包括柠檬酸、醋酸、氢氧化钠或盐酸中任意一种;
    可选地,所述组合物以重量份数计还包括淀粉1-80份;
    可选地,所述淀粉包括玉米淀粉、豌豆淀粉、绿豆淀粉、糊化淀粉、羟甲基淀粉、交联淀粉、麦芽糊精、氧化淀粉、酯化淀粉或醚化淀粉中任意一种或至少两种的组合。
  14. 一种根据权利要求1-13中任一项所述的检测***物隐血的组合物的制备方法,所述制备方法包括以下步骤:
    (1)将联苯胺、过氧化物与有机溶剂混合得到有机相;
    (2)将增稠剂、EDTA-2Na和水混合得到水相;
    (3)将水相和有机相混合,得到所述检测***物隐血的组合物;
    步骤(1)、(2)不区分先后顺序。
  15. 根据权利要求14所述的制备方法,其中,步骤(2)所述将增稠剂、EDTA-2Na和水混合得到水相还包括与pH调节剂混合;
    可选地,步骤(3)所述将水相和有机相混合还包括与淀粉混合。
  16. 一种根据权利要求1-13中任一项所述的检测***物隐血的组合物在制备隐血检测装置中的应用。
  17. 根据权利要求16所述的应用,其中,所述隐血检测装置包括检测试纸、检测板、试剂盒或检测管中任意一种。
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