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Composition, reagent containing the composition and use thereof

A composition and reagent technology, applied in biological testing, testing pharmaceutical preparations, material testing products, etc., can solve the problems of inconvenient operation, easy oxidation, short stability period, etc. in clinical testing, and achieve basic performance with long stable period and repeated detection high sex effect

Active Publication Date: 2022-07-12
BEIJING SICCEEDER TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] According to the different activators, the kits used to detect APTT on the market can be roughly divided into three categories: diatomaceous earth formulation, kaolin formulation and ellagic acid formulation. It is inconvenient for clinical testing operations; the dosage form of ellagic acid is a liquid reagent, which simplifies clinical testing operations, but it is easily oxidized, has a short stable period, and is less sensitive to heparin medication monitoring; diatomaceous earth dosage forms can be made into frozen Dry product, prolongs the storage period of the reagent. After reconstitution, it becomes a clear suspension and is not easily oxidized. It is often used for clinical monitoring of heparin medication. This dosage form can also be used for lupus anticoagulant screening and detection

Method used

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  • Composition, reagent containing the composition and use thereof
  • Composition, reagent containing the composition and use thereof
  • Composition, reagent containing the composition and use thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] Embodiment 1 The different experimental groups of each component concentration of freeze-dried reagent of the present invention:

[0065] The quality control plasma was used to detect the APTT values ​​corresponding to the reagents at different concentrations and ratios. The reagents at each concentration were detected three times and the average was taken to compare the basic APTT values ​​of the reagents at different concentrations and ratios. The relevant experimental data are shown in Table 1 below:

[0066] Table 1 Concentration of each component of the reagent of the present invention

[0067]

[0068] The results in Table 1 show that the concentrations of the components in the reagents provided in this experiment are: 0.5-10% diatomaceous earth, 0.5%-1% phospholipids, 1%-6% sucrose, 1%-5% mannitol, 0.5‰ ~1‰Chaps, 0.2‰~2‰Hepes, 0.5‰~5‰ thimerosal sodium, pH is 7.35~7.45, and the balance is water.

[0069] The above data shows that the optimal working concentr...

Embodiment 2

[0070] Example 2 Preparation of the reagent of the present invention

[0071] Accurately weigh 3% diatomaceous earth, 0.8% phospholipids, 2.5% sucrose, 3.5% mannitol, 0.5‰ Chaps, 0.3‰ Hepes, 0.8‰ thimerosal sodium, the balance is water, and mix. (wherein, % is the mass percentage).

[0072] The above components were mixed with water and dried in vacuum at a vacuum degree of 8Pa and a temperature of -35°C for 12 hours, at a temperature of 0°C for 7 hours, and at a temperature of 25°C for 9 hours.

[0073] Using the prepared reagent to detect the corresponding APTT value of the quality control plasma, the APTT value is 32.5s, which falls within the range of the quality control target value (31.0-33.0), indicating that the reagent using this ratio can achieve the intended use. .

Embodiment 3

[0074] Example 3 Preparation of the reagent of the present invention

[0075] Accurately weigh 0.5% diatomaceous earth, 1% phospholipids, 1% sucrose, 5% mannitol, 1‰ Chaps, 0.25‰ Hepes, 5‰ thimerosal sodium, the balance is water, and mix. (wherein, % is the mass percentage).

[0076] The above components were mixed with water and dried in vacuum for 10 hours at a vacuum degree of 12Pa and a temperature of -35°C, for 5 hours at a temperature of 0°C, and for 10 hours at a temperature of 25°C.

[0077] Use the prepared reagent to detect the corresponding APTT value of the quality control plasma. The APTT value is 34.7s, that is, it cannot fall within the range of the quality control target value (31.0 to 33.0), indicating that the reagent using this ratio cannot achieve the intended use. .

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Abstract

The present invention relates to the field of biotechnology, in particular to a composition, a reagent containing the composition and its application. The reagent of the invention is widely applicable to the automatic coagulation tester of the coagulation method for routine examination in the clinical laboratory of the hospital. The advantage is that the heparin sensitivity coefficient (1.67-2.23) of the reagent is moderate and controllable, which effectively ensures the reliability of clinical monitoring of heparin medication; the reagent has a good response to lupus anticoagulants and can be used for clinical lupus anticoagulant screening. The test value of the reagent for extremely abnormal clinical samples has high accuracy and good repeatability; the reagent has a long storage time and good stability after reconstitution. Therefore, the present invention provides reliable detection data for clinical diagnosis and treatment of thrombosis and hemostasis diseases, and is beneficial to further popularization and use in the market.

Description

technical field [0001] The present invention relates to the field of biotechnology, in particular to a composition, a reagent containing the composition and its application. Background technique [0002] Activated partial thromboplastin time (APTT) is the most sensitive and most commonly used screening test for the endogenous coagulation system. Sensitive screening test for coagulation activity of coagulation system, detection of endogenous coagulation factor deficiency and related inhibitors, screening of activated protein C resistance phenomenon, monitoring of heparin therapy, early diagnosis of disseminated intravascular coagulation (DIC), surgery Pre-inspection and other aspects have a wide range of uses. [0003] Activated partial thromboplastin time (APTT) is a coagulation function test index that reflects the comprehensive activity of coagulation factors in the endogenous coagulation pathway, especially the first stage. , XI, VIII, IX, and can also be used for prima...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N33/86G01N33/15
CPCG01N33/86G01N33/15
Inventor 丁重辉张丽君
Owner BEIJING SICCEEDER TECH CO LTD
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