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A liquid calibrator of glycosylated hemoglobin

A glycosylated hemoglobin and calibrator technology, applied in the field of biological preparations, can solve the problems of reducing protein content, inaccurate test results, unstable protein crystals, etc., achieving high protein content, improving storage conditions, and reducing production, transportation and storage costs. Effect

Active Publication Date: 2022-03-25
GUANGZHOU KEFEN BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the protein crystals of the freeze-dried powder are unstable during the reconstitution process, resulting in a decrease in its protein content
Therefore, testing with lyophilized HbA1c calibrator often leads to inaccurate test results

Method used

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  • A liquid calibrator of glycosylated hemoglobin
  • A liquid calibrator of glycosylated hemoglobin
  • A liquid calibrator of glycosylated hemoglobin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] This embodiment provides a liquid HBA1C calibrator and a preparation method thereof, the specific steps are as follows:

[0023] 1. Preparation of HBA1C calibration diluent:

[0024] 1. Diluent formula (1L)

[0025]

[0026] 2. Prepare the calibration dilution: weigh the required reagents according to the above formula and add them to the beaker, dissolve and mix well, adjust the pH value of the solution to 8.0, set the volume to 1L, filter through a 0.22μm filter membrane and store in 2~ 8°C.

[0027] 2. Preparation of glycated hemoglobin: extract red blood cells from blood samples, wash the obtained red blood cells, release the hemoglobin in the red blood cells, separate and purify the obtained hemoglobin, and prepare human glycated hemoglobin with a purity of more than 96% by using affinity ion chromatography .

[0028] At room temperature, take glycosylated hemoglobin and add it to the calibration diluent prepared above to adjust the concentration to 5.5%;

...

Embodiment 2

[0031] The only difference between this embodiment and embodiment 1 is that the diluent (1L) formula of this embodiment is as follows:

[0032]

[0033]

[0034] The Ph value of this embodiment is 7.0; the concentration of glycosylated hemoglobin is 5.5%.

Embodiment 3

[0036] The only difference between this embodiment and embodiment 1 is that the diluent (1L) formula of this embodiment is as follows:

[0037]

[0038] The pH value of this embodiment is 9.0; the concentration of glycosylated hemoglobin is 8.5%.

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PUM

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Abstract

The invention provides a liquid calibrator of glycosylated hemoglobin comprising the following components: phosphate buffer, sodium chloride, potassium chloride, glycine, Triton X‑100, BSA, NaN 3 and HBA1C. The liquid glycosylated hemoglobin calibrator of the invention can keep its protein content stable in a liquid state. It has been determined through experiments that the liquid glycated hemoglobin calibrator of the present invention can keep the protein content constant within 40 days under the condition of 2~8°C, and the protein content within one week under the condition of 37°C remains constant, and the highest protein content is The content can reach 14.5%. Compared with the commercially available dry powder calibrator, the calibrator of the present invention has high protein content and good stability, does not need to be refrigerated within a week, improves the storage conditions of the calibrator, and greatly reduces production, transportation and storage costs.

Description

technical field [0001] The invention belongs to the technical field of biological preparations, in particular to a liquid calibrator of glycosylated hemoglobin. Background technique [0002] Glycosylated hemoglobin (GHb) is the product of the combination of hemoglobin in red blood cells and carbohydrates in serum. It is formed through a slow, continuous and irreversible glycation reaction, and its content depends on the blood sugar concentration and the contact time between blood sugar and hemoglobin, but has nothing to do with blood drawing time, whether the patient is fasting, whether insulin is used or not. Therefore, GHb can effectively reflect the blood sugar control of diabetic patients in the past 1 to 2 months. GHb is composed of HbA1a, HbA1b, and HbA1c, of which HbA1c accounts for about 70% and has a stable structure, so it is used as a monitoring index for diabetes control. [0003] At present, there are two main types of glycated hemoglobin detection methods use...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/04
CPCG01N30/04G01N2030/042
Inventor 何明深
Owner GUANGZHOU KEFEN BIOTECH CO LTD