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Preparation method of stable glycated albumin calibrating material and quality control material

A technology of glycosylated albumin and calibrator, which is applied in the field of medical testing, can solve problems such as pollution and glycosylated albumin concentration fluctuations, and achieve the effect of rich raw material sources, good long-term stability, and improved stability

Pending Publication Date: 2015-11-25
NINGBO RUI BIO TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, the traditional glycosylated albumin calibrator and quality control products are made of serum, which may be contaminated by HIV or HPV. The glucose in the serum will also react with albumin continuously to form glycosylated The concentration fluctuates

Method used

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  • Preparation method of stable glycated albumin calibrating material and quality control material
  • Preparation method of stable glycated albumin calibrating material and quality control material
  • Preparation method of stable glycated albumin calibrating material and quality control material

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] First of all, the serum of healthy people was used, and the HIV, HCV and HTLV were all negative. Then centrifuge at 18000rpm*30min to remove the precipitate, and then dialyze with the dialysate to remove some small molecule interferences; wherein, the composition of the dialysate is: tris buffer (pH7.5): 50mM, sodium chloride: 9g / L, solvent: distilled water.

[0032] Secondly, add 5g / L glucose and 0.5g / L sodium azide to the dialyzed serum, place it in a constant temperature water bath at 37°C for 1 day to obtain a quality control product with a low quality control value, and 2 days to obtain a calibration product , 4 days to get quality control products with high quality control values.

[0033] Again, put the prepared calibration products and quality control products into dialysis bags respectively, place them in the dialysate at 4°C, change the dialysate every 12 hours, dialyze to remove excess glucose, and prevent further saccharification until glucose is used The ...

Embodiment 2

[0036] First of all, the serum of healthy people was used, and the HIV, HCV and HTLV were all negative. Then centrifuge at 18000rpm*30min to remove the precipitate, and then use the dialysate to dialyze to remove some small molecule interferers, wherein the composition of the dialysate is: tris buffer (pH7.5): 50mM, sodium chloride: 9g / L, solvent: distilled water.

[0037] Secondly, add 5g / L glucose and 0.5g / L sodium azide to the dialyzed serum, place it in a constant temperature water bath at 37°C for 1 day to obtain a quality control product with a low quality control value, and 2 days to obtain a calibration product , 4 days to get quality control products with high quality control values.

[0038] Again, put the prepared calibration products and quality control products into dialysis bags respectively, place them in the dialysate at 4°C, change the dialysate every 12 hours, dialyze to remove excess glucose, and prevent further saccharification until used The remaining gl...

Embodiment 3

[0041]First of all, the serum of healthy people was used, and the HIV, HCV and HTLV were all negative. Then centrifuge at 18000rpm*30min to remove the precipitate, and then use the dialysate to dialyze to remove some small molecule interferers, wherein the composition of the dialysate is: tris buffer (pH7.5): 50mM, sodium chloride: 9g / L, solvent: distilled water.

[0042] Secondly, add 5g / L glucose and 0.5g / L sodium azide to the dialyzed serum, place it in a constant temperature water bath at 37°C for 1 day to obtain a quality control product with a low quality control value, and 2 days to obtain a calibration product , 4 days to get quality control products with high quality control values.

[0043] Again, put the prepared calibration products and quality control products into dialysis bags respectively, place them in the dialysate at 4°C, change the dialysate every 12 hours, dialyze to remove excess glucose, and prevent further saccharification until glucose is used The re...

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Abstract

The invention relates to a preparation method of a stable glycated albumin calibrating material and a quality control material. The preparation method comprises the following steps of selecting serum, and removing settling and disturbance matters; adding glucose and preservative into the treated serum, arranging in a constant-temperature water bath with temperature of 35-38 DEG C, saccharifying, and respectively obtaining the glycated albumin calibrating material and the quality control material according to the saccharifying time; respectively packaging the prepared glycated albumin calibrating material and the quality control material, arranging in dialysates with temperature of 2-6 DEG C, dialyzing, and removing excessive glucose, until the content of the remained glucose is less than 0.1g / L; finally, adding the preservative and 10-50g / L of freeze-drying protecting agent into the dialyzed glycated albumin calibrating material and quality control material, freezing and drying to obtain a freeze-drying powder, dissolving again, and detecting the fixed value by a glycated albumin detection kit. The preparation method has the advantages that the sources of raw materials are sufficient, easy to obtain, the preparation technology is simple, and the stable glycated albumin calibrating material and the quality control material can be prepared by the serum of a healthy person.

Description

technical field [0001] The invention relates to a preparation method of a stable glycosylated albumin calibrator and a quality control product, belonging to the technical field of medical detection. Background technique [0002] Diabetes is a group of metabolic diseases characterized by hyperglycemia. The long-term high blood sugar in diabetes can lead to chronic damage and dysfunction of various tissues, especially the eyes, kidneys, heart, blood vessels, and nerves. It is the third chronic disease that seriously threatens human health after pathological changes, and seriously threatens human health. [0003] Glycated albumin is an indicator that reflects the average blood sugar level over the past 2-3 weeks. The reaction period of glycated hemoglobin, the "gold standard" of blood sugar testing, is shorter. Therefore, glycosylated albumin has advantages over glycosylated hemoglobin in the confirmation of therapeutic effect and the adjustment of clinical dosage. In addit...

Claims

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Application Information

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IPC IPC(8): G01N1/28A61K38/38A61P3/10
Inventor 张丽张闻周海滨王建飞
Owner NINGBO RUI BIO TECH
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