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A kind of stable biochemical compound calibrator and preparation method thereof

A calibrator and biochemical technology, applied in the field of biological in vitro diagnostics, can solve the problems of fewer analysis items and inconvenient clinical inspection work, and achieve the effects of reducing production costs, long storage validity period, and solving unstable storage

Active Publication Date: 2021-03-02
BIOSINO BIO TECH & SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For example, the biochemical multiple calibration products developed by Zhongsheng Beikong Biotechnology Co., Ltd. in China contain 21 items, which are valid for 18 months when stored at 2-8°C, and there are few analytical items, so the items not included need to be calibrated separately products, which brings great inconvenience to clinical testing work

Method used

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  • A kind of stable biochemical compound calibrator and preparation method thereof
  • A kind of stable biochemical compound calibrator and preparation method thereof
  • A kind of stable biochemical compound calibrator and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] A stable biochemical compound calibrator whose matrix is ​​serum and whose raw materials contain the following components:

[0053] 1) Protective substances:

[0054] Sucrose content 50g / L, mannitol content 50g / L, ascorbic acid content 1.0mmol / L

[0055] Octylphenoxyethylene ether content 0.50% (w / v) bovine serum albumin content 10.0g / L

[0056] NaN 3 Content 0.10% (w / v)

[0057] 2) Analytical components:

[0058]

[0059]

[0060] The preparation method of this stable biochemical composite calibrator comprises the steps:

[0061] 1) Collect waste blood from clinical examination, requiring hepatitis B virus surface antigen HBsAg, hepatitis C virus HCV antibody, human immunodeficiency virus HIV-1 and HIV-2 antibody, and syphilis to be negative;

[0062] 2) The serum was separated by centrifugation and filtered through a 0.2 μm filter membrane as a spare serum matrix;

[0063] 3) Analyze and measure the content of each calibration component in the serum accordin...

Embodiment 2

[0076] A stable biochemical compound calibrator whose matrix is ​​serum and whose raw materials contain the following components:

[0077] 1) Protective substances:

[0078] Trehalose content 50g / L, sorbitol content 50g / L, butylated hydroxyanisole content 1.0mmol / L

[0079] Triton-100 content 0.50% (w / v) bovine serum albumin content 10.0g / L

[0080] NaN 3 Content 0.10% (w / v)

[0081] 2) Analytical components:

[0082]

[0083] The preparation method of this stable biochemical composite calibrator comprises the steps:

[0084] 1) Collect waste blood from clinical examination, requiring hepatitis B virus surface antigen HBsAg, hepatitis C virus HCV antibody, human immunodeficiency virus HIV-1 and HIV-2 antibody, and syphilis to be negative;

[0085] 2) The serum was separated by centrifugation and filtered through a 0.2 μm filter membrane as a spare serum matrix;

[0086] 3) Analyze and measure the content of each calibration component in the serum according to conventi...

experiment example

[0098] In order to study the influence of the protective agent on the stability of the calibrator and the resolubility of the product, after adding each analytical component (same as Example 1), design the formulas of groups 1-8 in the following table 3, and the ninth group is used as blank control serum. No protective agent is added, the product is prepared after freeze-drying and packaging, and stored in a 2-8°C refrigerator and a 37°C incubator respectively. The corresponding kits and calibrators of Zhongsheng Beikong Biotechnology Co., Ltd. were used to determine the content of each component in the product, and the influence of different protective agents on the stability and resolubility of the product was observed. The experimental results are shown in Table 3, Table 4 and Table 5.

[0099] The experimental results show that: in the accelerated test at 37°C for 14 days, the recovery rate of the calibrator added with the protective agent is greater than 75%, and the reco...

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Abstract

The invention relates to a stable biochemical compound calibrator and a preparation method thereof, belonging to the technical field of biological in vitro diagnosis. The biochemical composite calibrator of the present invention, due to the addition of a composite protective substance composed of excipients, antioxidants, surfactants, stabilizers, and preservatives, makes the analytical components in the calibrator stable, and can be stable at room temperature and protected from light for 1 It can be stable for 2 years at 4°C in the dark, and 3 years in the dark at -20°C; the calibrator of the present invention has inactivated various potential pathogenic microorganisms due to the use of riboflavin photochemical method in the preparation process , so that the calibrator has no potential harmfulness of pathogenic microorganisms; the biochemical compound calibrator of the present invention contains many components, which greatly facilitates clinical use; the preparation method can be traced to international or domestic reference materials, ensuring clinical test results accuracy.

Description

technical field [0001] The invention relates to a stable biochemical compound calibrator and a preparation method thereof, belonging to the technical field of biological in vitro diagnosis. Background technique [0002] The demand for clinical diagnostic reagents in my country is growing rapidly, and there is still a certain gap to achieve a well-off level of medical care. At present, the annual medical inspection cost in my country is only 500 million U.S. dollars, and the per capita is only 0.5 U.S. dollars, which is far below the requirements of the World Health Organization. At least an average medical examination fee of US$ 2 per person per year should be achieved. According to statistical analysis reports, in the past five years and the next five years, the annual growth rate of the international in vitro diagnostic industry is 3-5%. The annual growth rate of the domestic in vitro diagnostic industry is about 15-20%, so the potential market for biochemical reagents in ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N1/28G01N1/38
CPCG01N1/28G01N1/38
Inventor 张勇蒋琳
Owner BIOSINO BIO TECH & SCI
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