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D-dimer quality control product and preparation method thereof

A technology for constitution and inhibitor, which is applied in the field of preparing D-dimer quality control products by using bovine plasma, can solve the problems of unsuitability for commercial production, high price, and difficulty in obtaining, and achieves easy acquisition, low production cost, and storage time. prolonged effect

Active Publication Date: 2013-07-10
SHANGHAI SUNBIO TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the indoor quality control products for D-dimer determination in China are all imported products, which are expensive
There are also reports in the literature that D-dimer quality control products are prepared from the remaining plasma after experimental testing. However, the source of raw materials used in this method is human plasma, which is not easy to obtain and is not suitable for commercial production.

Method used

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  • D-dimer quality control product and preparation method thereof
  • D-dimer quality control product and preparation method thereof
  • D-dimer quality control product and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1D- 2

[0022] The preparation of embodiment 1D-dimer quality control product

[0023] 1. Bovine plasma: Add 3.8% trisodium citrate anticoagulant solution to the blood collected from the jugular vein of cattle, and the volume ratio of blood to anticoagulant is 9:1. The blood added with anticoagulant was centrifuged for 30 minutes with a relative centrifugal force of 2000g, and the upper layer of plasma was carefully separated and drawn.

[0024] 2. Lyoprotectant: TAPSO1.3%, sodium chloride 2%, sodium azide 1.0g / L, mannitol 10g / L, bovine serum albumin 20g / L, aprotinin 80000KIU / L.

[0025] 3. Preparation of D-dimer quality control:

[0026] (1) Divide the bovine plasma into glass test tubes, add 0.025mol / L calcium chloride solution with 40% plasma volume to each tube, and bathe in water at 37°C for 15 minutes until the plasma coagulates.

[0027] (2) Add plasmin solution to the plasma to make the final concentration 240U / mL, place it in a 37°C water bath for 6 hours, and stir it with ...

Embodiment 2D- 2

[0030] Embodiment 2D-dimer quality control product is compared to reagent change sensitivity

[0031] 1. Accurately reconstitute the D-dimer quality control product prepared in Example 1 and the commercially available D-dimer quality control product from Siemens, Germany.

[0032] 2. Use the D-dimer detection kit of Siemens company in Germany to detect D-dimer, and the detection method is latex immunoturbidimetric method. R in the kit 2 The reagent (immune latex reagent) was serially diluted with distilled water to obtain R 2 The concentration is: 100%, 80%, 60%, 40%, 20%, 10% reagent.

[0033] 3. Use serially diluted R 2 Reagents and other reagents in the kit, the D-dimer quality control product prepared in Example 1 and the commercially available D-dimer quality control product from Siemens, Germany were tested, and the test results are shown in Table 1. The result shows: detection reagent R 2 Concentration from 100% to 10%, the D-dimer quality control product of the pr...

Embodiment 3D- 2

[0036] Example 3D - Detection of the stability of the dimer quality control product.

[0037] 1. Open bottle stability test

[0038] The D-dimer quality control product prepared in Example 1 and the German Siemens company quality control product were accurately reconstituted respectively, stored at room temperature (15-25°C), and regularly sampled once a day to detect the D-dimer quality control product concentration. The linear regression method was used to analyze the stability of the quality control substance, and the slope b of the linear equation was tested to see whether there was a significant difference from 0. If P0.05, it indicated that the concentration of the analyte was between It is basically stable during the measurement time. The test results are shown in Table 2 and figure 1 shown.

[0039] Table 2 Open bottle stability test results

[0040]

[0041] The regression equation of the quality control product of the present invention is: y=-0.0182x+31.882, ...

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Abstract

The invention relates to the field of quality control of clinical blood coagulation detection projects, and in particular relates to a method for preparing a D-dimer quality control product. The method comprises the following steps: carrying out recalcification on bovine plasma and solidifying; adding an enzyme capable of degrading fibrous protein, thereby dissolving a fibrous protein clot; stopping the reaction by using a protease inhibitor; diluting a generated D-dimer mother liquor by using a freeze-dried protecting solution; and freeze-drying, thereby obtaining the D-dimer quality control product. The prepared D-dimer quality control product is very sensitive to the change of a detection reagent and good in stability, thereby satisfying the quality control requirement of clinical D-dimer detection.

Description

technical field [0001] The invention relates to the field of quality control of clinical coagulation test items, in particular to a method for preparing a D-dimer quality control product by using bovine plasma. Background technique [0002] Fibrinogen is the protein with the highest content in mammalian plasma, and it has high homology among different mammals. When fibrinogen is activated in animals, fibrin clots form and blood coagulates. The fibrinolytic system is activated at the same time as blood coagulation, which is the most important blood anticoagulant system in the human body: when fibrin coagulates, the plasminogen activator activates the conversion of plasminogen into plasmin, and the process of fibrinolysis begins , Plasmin degrades fibrin clots to form various soluble fragments, forming fibrin degradation products (FDP). FDP is composed of: X, Y, D-dimer, middle fragment E fragment, etc. [0003] D-dimer is the smallest fragment of fibrin degradation products,...

Claims

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Application Information

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IPC IPC(8): G01N33/96
Inventor 谢永华
Owner SHANGHAI SUNBIO TECH
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