D-dimer and preparation method of FDP composite quality control product

A technique for dimers and quality control products, which is applied in the direction of analytical materials and instruments, can solve the problems of incomplete degradation of fibrin, lower quality of composite quality control products, and inactivation of fibrin, so as to avoid quality degradation and errors Small, high-purity effects

Active Publication Date: 2018-02-09
北京众驰伟业科技发展有限公司
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  • Application Information

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Problems solved by technology

Although the preparation method has obtained D-dimer and FDP composite quality control products, due to the fact that solid particles are easily produced during the preparation process, the reaction of degrading fibrin is not complete, resulting in a large waste; When plasma is used, it is easy to inactivate fibrin, thereby reducing the quality of composite quality control products

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  • D-dimer and preparation method of FDP composite quality control product
  • D-dimer and preparation method of FDP composite quality control product
  • D-dimer and preparation method of FDP composite quality control product

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Experimental program
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Effect test

Embodiment 1

[0056] The preparation method of D-dimer and FDP composite quality control product in the present embodiment is as follows:

[0057] (1) In the SPF experiment, 150 mL of blood was collected from the rabbit heart and poured into a 250 mL Erlenmeyer flask with 30 glass beads with a diameter of 0.5 cm in advance, and shaken horizontally.

[0058] (2) The white fibrinogen floating on the blood obtained in step (1) was redissolved with sterile physiological saline.

[0059] (3) Use neutral protease with a concentration of 2000IU / mL to enzymolyze the fibrinogen obtained in step (2), relative to 1 mL of the fibrinogen solution reconstituted in step (2), the amount of protease in step (3) 50IU, 38°C for 10 hours, and then heated to 100°C for 2 hours to stop the enzymatic hydrolysis reaction, to obtain the D-dimer and FDP composite mother solution;

[0060] (4) The composite mother liquor obtained in step (3) is diluted with a protective solution consisting of HEPES 2% (w / v), trehalos...

Embodiment 2

[0062] The preparation method of D-dimer and FDP composite quality control product in the present embodiment is as follows:

[0063] (1) In the SPF experiment, 200 mL of blood was taken from the bovine heart and poured into a 500 mL Erlenmeyer flask pre-placed with 35 glass beads with a diameter of 0.7 cm, and shaken horizontally.

[0064] (2) The white fibrinogen floating on the blood obtained in step (1) was redissolved with sterile physiological saline.

[0065] (3) Use neutral protease with a concentration of 2000IU / mL to enzymolyze the fibrinogen obtained in step (2), relative to 1 mL of the fibrinogen solution reconstituted in step (2), the amount of protease in step (3) 80IU at 35°C for 15 hours, then raised to 50°C for 8 hours to stop the enzymatic hydrolysis reaction, to obtain D-dimer and FDP composite mother solution.

[0066] (4) The composite mother liquor obtained in step (3) is diluted with a protective solution consisting of HEPES 1% (w / v), trehalose 1g / L, bov...

Embodiment 3

[0068] The preparation method of D-dimer and FDP composite quality control product in the present embodiment is as follows:

[0069] (1) Take 120 mL of blood from the heart of the SPF experimental rat and pour it into a 150 mL Erlenmeyer flask with 25 glass beads with a diameter of 0.3 cm in advance, and shake it horizontally.

[0070] (2) The white fibrinogen floating on the blood obtained in step (1) was redissolved with sterile physiological saline.

[0071] (3) Use neutral protease with a concentration of 2000IU / mL to enzymolyze the fibrinogen obtained in step (2), relative to 1 mL of the fibrinogen solution reconstituted in step (2), the amount of protease in step (3) 100IU, 36°C enzymatic hydrolysis for 13 hours, then raised to 70°C for 5 hours to terminate the enzymatic hydrolysis reaction, to obtain D-dimer and FDP composite mother solution;

[0072] (4) The composite mother liquor obtained in step (3) is diluted with a protective solution consisting of HEPES 3% (w / v)...

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Abstract

The invention discloses a D-dimer and a preparation method of an FDP composite quality control product. The preparation method comprises the following steps that 1, fresh blood is poured into a glasscontainer pre-containing glass beads and then is horizontally shaken; 2, white fibrinogen floating on the blood and obtained in the step 1 is re-dissolved; 3, the fibrinogen obtained in the step 2 issubjected to enzymolysis with protease to obtain the D-dimer and an FDP composite mother solution; 4, the composite mother solution obtained in the step 3 is diluted with protection liquid, so that the D-dimer and FDP in the composite mother solution reach target concentration, and the D-dimer and the FDP composite quality control product are obtained. The preparation method is simple in operationand accurate in concentration, large-scale production is facilitated, and the accurate and reliable quality control product is provided for clinical medical detection of D-dimer and the FDP.

Description

technical field [0001] The invention belongs to the technical field of in vitro diagnostic reagents, and relates to a preparation method of a composite quality control product of D-dimer and FDP. Background technique [0002] In the hemagglutination test, it is often necessary to determine the content of D-dimer, fibrin and fibrinogen degradation products (Fibringen and Fibrin Degradation Products, FDP). With the development of technology, more and more blood coagulation tests are completed by automated blood coagulation analyzers. In order to monitor the operation of the instrument, quality controls of D-dimer and FDP are required. [0003] Direct isolation of D-dimer or FDP from human plasma has limited sources and low yields. Quality control materials for D-dimer or FDP can be prepared from animal plasma to solve the source problem. [0004] A single quality control product containing D-dimer or FDP is inconvenient to use, and the accuracy of the quality control product ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N35/00
CPCG01N35/00623
Inventor 杨军京
Owner 北京众驰伟业科技发展有限公司
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