Preparation and application of glycosylated hemoglobin quality control product

A technology of glycosylated hemoglobin and hemoglobin, which is applied in the field of medical testing and determination, and achieves the effects of long storage time, good stability and wide application.

Pending Publication Date: 2022-07-15
DAAN GENE CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The technical problem to be solved by the present invention is to overcome the defects and deficiencies in the preparation of the existing glycosylated hemoglobin control product, and to provide a preparation and application of the glycosylated hemoglobin control product

Method used

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  • Preparation and application of glycosylated hemoglobin quality control product
  • Preparation and application of glycosylated hemoglobin quality control product
  • Preparation and application of glycosylated hemoglobin quality control product

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Example 1 Preparation of Glycated Hemoglobin Solution 1 Concentrate

[0048] 1. Red blood cell processing

[0049] Collect 200mL of EDTA anticoagulated whole blood samples from healthy people, each sample was tested for HIV (HIV1, HIV2) antibodies, hepatitis B surface antigen (HbsAg) and hepatitis C virus (HCV) antibodies, and the results were all negative. , if one of the items is positive, the samples shall be disposed of in accordance with the relevant medical waste disposal regulations. The collected whole blood samples were centrifuged at about 1900g, the upper plasma was discarded, and normal saline was added, and the red blood cells were washed by pipetting repeatedly with a pipette. .

[0050] 2. Preparation of Glycated Hemoglobin Solution 1 Concentrate

[0051] (1) Preparation of treatment solution

[0052] Take 0.2g of 3-sulfopropyltetradecyldimethylbetaine and 0.028g of sodium nitrite and dissolve them in 100mL of pure water.

[0053] (2) Preparation of ...

Embodiment 2

[0055] Example 2 Preparation of Glycated Hemoglobin Solution 2 Concentrate

[0056] Take the glycated hemoglobin solution 1 (100 mL) prepared in Example 1, add glucose and dissolve it, the final concentration of glucose is 18 mmol / L, and then the mixed solution is placed at 37° C. and incubated for 60 days. After the incubation, glucose oxidase was added to remove unreacted glucose, and the glycosylation reaction was terminated. The final concentration of glucose oxidase was 10KU / L. The solution after glucose removal was placed at 37°C for 7 days to eliminate hydrogen peroxide; Concentrate with an ultrafiltration centrifuge tube with a rate of 30KD, centrifuge at 14000g for 10min to obtain a concentrated solution of glycosylated hemoglobin solution 2 (25mL); store at 2-8°C for later use.

Embodiment 3

[0057] Example 3 Preparation of Glycated Hemoglobin Solution 2 Concentrate

[0058] Take the glycosylated hemoglobin solution 1 (100 mL) prepared in Example 1, add glucose and dissolve it, the final concentration of glucose is 36 mmol / L, and then the mixed solution is placed at 37° C. and incubated for 30 days. After the incubation, glucose oxidase was added to remove unreacted glucose, and the glycosylation reaction was terminated. The final concentration of glucose oxidase was 10KU / L. The solution after glucose removal was placed at 37°C for 7 days to eliminate hydrogen peroxide; Concentrate with an ultrafiltration centrifuge tube with a rate of 30KD, centrifuge at 14000g for 10min to obtain a concentrated solution of glycosylated hemoglobin solution 2 (25mL); store at 2-8°C for later use.

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Abstract

The invention discloses preparation and application of a glycosylated hemoglobin quality control product. The preparation method of the glycosylated hemoglobin quality control product is simple, and the glycosylated hemoglobin quality control product can be rapidly prepared without complex operation and expensive instruments; the prepared glycosylated hemoglobin quality control product is good in stability, the glycosylated hemoglobin value is within the mean value range of +/-10% after the glycosylated hemoglobin quality control product is stored at 2-8 DEG C for 24 months, and the preservation time is

Description

technical field [0001] The invention belongs to the technical field of medical testing and determination, in particular to the preparation and application of a glycosylated hemoglobin control product. Background technique [0002] Glycated hemoglobin (HbA1c) is the product of the combination of hemoglobin in red blood cells and sugars (mainly glucose) in serum through a non-enzymatic reaction. It is generally believed that the glycated hemoglobin concentration can effectively reflect the average blood glucose level over the past 8 to 12 weeks. Glycated hemoglobin is composed of HbA1a, HbA1b, and HbA1c, of which HbA1c accounts for about 70%, and the structure is relatively stable. It is often used as a monitoring index for diabetes control in clinical practice. [0003] At present, there are many methods for clinical determination of glycosylated hemoglobin (HbA1c) content, such as ion exchange chromatography (HPLC), affinity chromatography, electrophoresis, immunoassay, enz...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N1/28G01N33/72G01N33/531
CPCG01N1/28G01N33/723G01N33/531G01N2800/042G01N2333/805
Inventor 蒋析文齐文闯吴润锋段少卿简俊兴刁雪吕淑媚
Owner DAAN GENE CO LTD
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