WO2021073081A1 - Activateur pour appareil de thrombélastographie - Google Patents

Activateur pour appareil de thrombélastographie Download PDF

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Publication number
WO2021073081A1
WO2021073081A1 PCT/CN2020/090324 CN2020090324W WO2021073081A1 WO 2021073081 A1 WO2021073081 A1 WO 2021073081A1 CN 2020090324 W CN2020090324 W CN 2020090324W WO 2021073081 A1 WO2021073081 A1 WO 2021073081A1
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WO
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Prior art keywords
activator
ellagic acid
total weight
thromboelastometer
tris
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PCT/CN2020/090324
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English (en)
Chinese (zh)
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李钢
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常熟常江生物技术有限公司
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Publication of WO2021073081A1 publication Critical patent/WO2021073081A1/fr

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    • G—PHYSICS
    • 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
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/49—Blood
    • G01N33/4905—Determining clotting time of blood
    • G—PHYSICS
    • 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
    • G01N33/86—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood coagulating time or factors, or their receptors

Definitions

  • the invention relates to the technical field of biomedicine, in particular to an activator of a thromboelastometer during use.
  • thrombootic diseases such as myocardial infarction, cerebral infarction, etc.
  • the blood coagulation process plays a key role in thrombosis, and it is also the formation of thrombus.
  • anticoagulant drugs are also used as the main measures for the treatment and prevention of thrombotic diseases. Medical research has confirmed that the risk of thrombotic diseases and bleeding diseases is increased when the blood coagulation function is abnormal. Therefore, in order to maintain the body in a healthy state and avoid the occurrence of thrombosis or bleeding diseases, it is necessary to control the blood coagulation function within a reasonable functional state range.
  • Thrombelastograghy is a detection method of coagulation test. It uses whole blood to detect the interaction between platelets, coagulation factors, fibrinogen, fibrinolytic system and other cellular components, reflecting the dynamic changes of blood coagulation. Including the formation speed of fibrin, the solidity of the dissolved state and the gelatinous state, and the index of elasticity.
  • the indicators are related to the entire coagulation process, and can be continuously monitored to accurately raise the patient's coagulation profile. Such as: low coagulation, high coagulation, or hyperfibrinolysis. If it is hypocoagulation, the cause of hypocoagulation can be further judged (coagulation factor deficiency, low fibrinogen level, low platelet activity or number).
  • TEG to guide blood transfusion
  • TEG can greatly reduce the amount of blood products, and can solve the problems of when, what, and how much in the blood component transfusion treatment. It can provide scientific and scientific guidance for clinicians and blood bank personnel to guide and monitor the use of blood products. Objective and reliable basis.
  • TEG can quickly simplify the diagnosis of coagulation disorders, allowing doctors to effectively deal with coagulation abnormalities, and prevent coagulation abnormalities from causing hemorrhage. Therefore, TEG is the most effective coagulation function monitoring for some complex operations, especially cardiovascular and liver operations. method.
  • the kaolin activator is a suspension of ultra-fine kaolin powder, and its disadvantage is that it is easy to precipitate. Although it has been shaken or stirred before use, the layering phenomenon still exists during use. In this way, during operation, the pipette tip of the liquid feeder will absorb different layers of suspension.
  • the activator in the upper layer of the suspension is relatively thin, and the bottom of the suspension is thicker, which will lead to errors in the detection results.
  • the gradual popularization of automated testing, and more reagents in automated equipment will also cause suspension reagents to continue to decrease and increase in concentration as they are used, causing deviations in detection. In order to solve the above technical problems, the present invention comes from this.
  • the purpose of the present invention is to overcome the shortcomings of the existing activator reagent kaolin during the use of the thromboelastometer, and to provide a kind of activation that is suitable for clinical promotion and is easy to use, without stirring and shaking, and with reliable and stable detection results. Agent.
  • the first aspect of the present invention is to provide an activator for a thromboelastometer, which contains ellagic acid.
  • the ellagic acid content is 0.001-10 wt% of the total weight of the activator.
  • the ellagic acid content may be 0.01-1 wt% of the total weight. More preferably, the ellagic acid content is 0.01-1 wt% of the total weight.
  • the acid content can be 0.1-1 wt% of the total weight.
  • the activator may also include phospholipids, which can make the detection more stable.
  • the phospholipid can be cephalin or lecithin, and the phospholipid content is 0.01-1 wt% of the total weight.
  • the activator may include a Tris-HCl buffer with a pH of 7.2, 0.01-0.5 wt% Proclin-300, and 0.001-10 wt% ellagic acid.
  • the activator includes the following components:
  • Tris-HCl buffer of pH 7.2 which contains Proclin-300 in an amount of 0.01-0.5 wt% of the total weight and ellagic acid in an amount of 0.001-10 wt% of the total weight;
  • the second aspect of the present invention also provides a preparation method of an activator used in a thromboelastometer, which includes the following steps:
  • step (2) after adding ellagic acid, phospholipids are also added.
  • the third aspect of the present invention also provides the use of the above-mentioned activator in a thromboelastometer, and the implementation method of the use may include the following steps:
  • the thromboelastometer automatically starts the detection to obtain the detection value of the sample after the activation of ellagic acid.
  • ellagic acid and kaolin have the same activation principle, activation process, and activation pathways of blood-related coagulation factors, the clinical significance and data analysis of the detection results of ellagic acid are consistent with traditional kaolin reagents.
  • the present invention provides a reagent composed of ellagic acid as an activator for analysis and evaluation of blood coagulation function.
  • the present invention is suitable for thromboelastometer to measure the coagulation method.
  • the coagulation elasticity obtained in the blood sample is tested.
  • the detection value through further calculation, obtains the blood coagulation function detection result.
  • ellagic acid as an activator is characterized by non-precipitation, which is especially suitable for automatic thromboelastography, making the detection results more reliable and suitable for clinical promotion.
  • Figure 1 is a graph of sample detection values in Example 1.
  • Raw materials and reagents Tris, HCl, Proclin-300 (SIGMA); phospholipids (SIGMA); ellagic acid, calcium chloride (China National Pharmaceutical Company);
  • the activator used for thrombus elasticity meter first prepare Tris-HCl buffer solution, pH 7.2, add 0.1wt% Proclin-300 to the Tris-HCl buffer solution, stir well for use; add ellagitans to the aforementioned solution
  • the content of ellagic acid is 0.1% by weight of the total weight, and the mixture is evenly stirred to obtain the activator.
  • a test task is issued.
  • the instrument adds an activator containing ellagic acid to the blood sample to be tested, and then adds a calcium chloride solution to coagulate the blood.
  • the thromboelastometer automatically starts to detect, and the measured value of the sample after the activation of ellagic acid is shown in Table 1, and the diagram is shown in Figure 1.
  • ellagic acid and kaolin have the same activation principle, activation process, and activation pathways of blood-related coagulation factors, the clinical significance and data analysis of the detection results of ellagic acid are consistent with traditional kaolin reagents.
  • the activator used for thrombus elasticity chart instrument first prepare Tris-HCl buffer solution, pH 7.2, add 0.2wt% Proclin-300 to the Tris-HCl buffer solution, stir evenly for later use; add ellagitans to the aforementioned solution
  • the content of ellagic acid is 0.1% by weight of the total weight, and the mixture is evenly stirred to obtain the activator.
  • the activator used for thrombus elasticity chart instrument first prepare Tris-HCl buffer solution, pH 7.2, add 0.2wt% Proclin-300 to the Tris-HCl buffer solution, stir evenly for later use; add ellagitans to the aforementioned solution
  • the content of ellagic acid is 0.15 wt% of the total weight, and the activator is obtained by stirring evenly.
  • the activator used for thrombus elasticity chart instrument first prepare Tris-HCl buffer solution, pH 7.2, add 0.2wt% Proclin-300 to the Tris-HCl buffer solution, stir evenly for later use; add ellagitans to the aforementioned solution
  • the content of ellagic acid is 0.1% by weight of the total weight, and the mixture is evenly stirred, and then phospholipids with a content of 0.01% by weight of the total weight are added, and the activator is obtained by stirring evenly.
  • Example 2 The activator prepared in Example 1 was stored under normal conditions for 7 days, and then tested in the same manner as in Example 1. The measured values of the samples after the activation of ellagic acid are shown in Table 2.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Urology & Nephrology (AREA)
  • Medicinal Chemistry (AREA)
  • Food Science & Technology (AREA)
  • Pathology (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Ecology (AREA)
  • Biophysics (AREA)
  • Biotechnology (AREA)
  • Cell Biology (AREA)
  • Microbiology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)

Abstract

L'invention concerne un activateur pour un appareil de thrombélastographie et son procédé de préparation. L'activateur comprend un acide ellagique, et la teneur en acide ellagique est de 0,001 à 10 % en poids du poids total de l'activateur. Comme l'acide ellagique ne se précipite pas, lors de l'utilisation de l'acide ellagique comme activateur de l'appareil de thrombélastographie, le résultat de la détection est plus fiable, il est donc approprié pour une vulgarisation clinique.
PCT/CN2020/090324 2019-10-15 2020-05-14 Activateur pour appareil de thrombélastographie WO2021073081A1 (fr)

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CN201910977169.5 2019-10-15
CN201910977169.5A CN110824154A (zh) 2019-10-15 2019-10-15 用于血栓弹力图仪的激活剂

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Publication number Priority date Publication date Assignee Title
CN110824154A (zh) * 2019-10-15 2020-02-21 常熟常江生物技术有限公司 用于血栓弹力图仪的激活剂
CN112162103A (zh) * 2020-09-03 2021-01-01 北京汇文源美生物科技有限公司 一种全自动血栓弹力图活化凝血检测试剂及其制备方法和应用
CN113848332B (zh) * 2021-09-17 2024-04-19 广州徕西姆医学诊断技术有限公司 一种血栓弹力图检测试剂及其制备方法和应用

Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101221189A (zh) * 2007-01-12 2008-07-16 上海太阳生物技术有限公司 一种用于测定活化部分凝血活酶时间aptt的体外诊断试剂盒
US20140038205A1 (en) * 2011-02-18 2014-02-06 Precision Biologic Inc. Methods and compositions relating to coagulation assays
CN106290923A (zh) * 2016-08-01 2017-01-04 重庆鼎润医疗器械有限责任公司 一种活化凝血检测试剂及其应用
CN106885895A (zh) * 2017-02-27 2017-06-23 常熟常江生物技术有限公司 血小板功能检测方法
CN107561257A (zh) * 2017-08-16 2018-01-09 北京乐普医疗科技有限责任公司 一种评估肝素类药物疗效及残留情况的检测方法
US20180059124A1 (en) * 2016-08-24 2018-03-01 Mubin I. Syed APPARATUS AND METHOD FOR EARLY IDENTIFICATION OF tPA RESISTANCE FOR CLOT DISSOLUTION IN PATIENTS
CN107942080A (zh) * 2016-10-13 2018-04-20 北京众驰伟业科技发展有限公司 一种活化部分凝血活酶时间检测试剂及其检测方法
CN109884326A (zh) * 2019-03-27 2019-06-14 深圳优迪生物技术有限公司 血小板聚集功能检测试剂盒
CN109884327A (zh) * 2019-03-27 2019-06-14 深圳优迪生物技术有限公司 功能性纤维蛋白原激活剂检测及其应用
CN110208513A (zh) * 2019-07-03 2019-09-06 常熟常江生物技术有限公司 一种血液中肝素或肝素类物质的检测方法和试剂盒
CN110824154A (zh) * 2019-10-15 2020-02-21 常熟常江生物技术有限公司 用于血栓弹力图仪的激活剂

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2822462B1 (fr) * 2001-03-23 2005-07-15 Stago Diagnostica Composes activateurs de la coagulation endogene utilisation pour l'exploration de la coagulation endogene
CN105445478B (zh) * 2015-11-12 2017-08-29 武汉中太生物技术有限公司 活化部分凝血活酶时间测定试剂盒及其制备方法
CN107561295B (zh) * 2017-08-16 2020-04-17 北京乐普医疗科技有限责任公司 一种血栓弹力图普通杯检测试剂盒及其使用方法
CN108226538B (zh) * 2017-12-29 2020-08-18 广州万孚生物技术股份有限公司 活化部分凝血活酶时间测定试剂
CN108226539B (zh) * 2018-01-12 2020-09-18 三诺生物传感股份有限公司 一种活化部分凝血活酶时间检测试剂及检测方法
CN108761104A (zh) * 2018-05-21 2018-11-06 深圳优迪生物技术有限公司 凝血激活剂及其应用
CN110108890A (zh) * 2019-05-05 2019-08-09 深圳优迪生物技术有限公司 活化部分凝血活酶时间测定试剂及其应用

Patent Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101221189A (zh) * 2007-01-12 2008-07-16 上海太阳生物技术有限公司 一种用于测定活化部分凝血活酶时间aptt的体外诊断试剂盒
US20140038205A1 (en) * 2011-02-18 2014-02-06 Precision Biologic Inc. Methods and compositions relating to coagulation assays
CN106290923A (zh) * 2016-08-01 2017-01-04 重庆鼎润医疗器械有限责任公司 一种活化凝血检测试剂及其应用
US20180059124A1 (en) * 2016-08-24 2018-03-01 Mubin I. Syed APPARATUS AND METHOD FOR EARLY IDENTIFICATION OF tPA RESISTANCE FOR CLOT DISSOLUTION IN PATIENTS
CN107942080A (zh) * 2016-10-13 2018-04-20 北京众驰伟业科技发展有限公司 一种活化部分凝血活酶时间检测试剂及其检测方法
CN106885895A (zh) * 2017-02-27 2017-06-23 常熟常江生物技术有限公司 血小板功能检测方法
CN107561257A (zh) * 2017-08-16 2018-01-09 北京乐普医疗科技有限责任公司 一种评估肝素类药物疗效及残留情况的检测方法
CN109884326A (zh) * 2019-03-27 2019-06-14 深圳优迪生物技术有限公司 血小板聚集功能检测试剂盒
CN109884327A (zh) * 2019-03-27 2019-06-14 深圳优迪生物技术有限公司 功能性纤维蛋白原激活剂检测及其应用
CN110208513A (zh) * 2019-07-03 2019-09-06 常熟常江生物技术有限公司 一种血液中肝素或肝素类物质的检测方法和试剂盒
CN110824154A (zh) * 2019-10-15 2020-02-21 常熟常江生物技术有限公司 用于血栓弹力图仪的激活剂

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