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Quality control objects of whole blood, and production method

A production process and blood quality technology, applied in the field of whole blood quality control substances and production processes, can solve problems such as unfavorable cell membrane protection, good indoor quality control results, and uncontrolled instrument status, and achieve a reasonable concentration control level and bottle-to-bottle difference. Small, the effect of controlling the difference between bottles

Active Publication Date: 2006-12-06
SICHUAN MACCURA BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the production of whole blood quality control materials is mostly prepared with finished bank blood. The main components of maintenance bank blood are citric acid, sodium citrate, glucose, sodium dihydrogen phosphate, and adenine; the fixative is a single component glutaraldehyde , easy to cause platelet aggregation and changes in cell morphology, the maintenance time is generally 1 to 3 months, and the stability is poor
Chinese patent 1263200 discloses a hematological cell three-differentiation whole blood quality control substance, which uses poultry blood and hoofed animal blood to replace white blood cells and platelets in the quality control substance respectively. Due to the basic effect with clinical samples in actual work, the histogram The picture shows that different from clinical specimens, the indoor quality control results may be good, but the instrument status is not under control
On the other hand, the production process is the production and recombination of single components (red blood cells, white blood cells and platelets), the production steps are cumbersome, the blood is easily polluted, and it is a suspension, which is not easy to be uniform and needs to be stirred, which is not conducive to the protection of the cell membrane and is easy to cause accidents. Blood

Method used

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  • Quality control objects of whole blood, and production method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Whole blood quality control substance formula of the present invention:

[0016] 1) Type O blood 400ml

[0017] 2) Anti-aggregation agent 35ml / 400ml blood

[0018] Wherein, antipolymerization agent formula is by weight of each component in 1 liter of water:

[0019] Citric acid 2.22g / L

[0020] Sodium citrate 26.3g / L

[0021] EDTA-Na 60g / L

[0022] Glucose 25g / L

[0023] Sodium dihydrogen phosphate 2.25g / L

[0024] Adenine 0.275g / L

[0025] 3) Fixative 0.8ml / 400ml blood

[0026] Wherein, fixative formulation is by volume ratio:

[0027] Ethanol: glutaraldehyde = 30ml: 1.8ml

[0028] 4) Protective agent 15ml / 400ml blood

[0029] Wherein, the protective agent formula is by weight of each component contained in 1 liter of water:

[0030] Aspirin 1.7g

[0031] Dipyridamole 0.3g

[0032] Penicillin - 13 million units

[0033] Firstly prepare the anti-aggregation agent, fixative and protective agent according to the above proportions, mix the three components ev...

Embodiment 2

[0035] Whole blood quality control substance formula of the present invention:

[0036] 1) Type A blood 400ml

[0037] 2) Anti-aggregation agent 50ml / 400ml blood

[0038] Wherein, antipolymerization agent formula is by weight of each component in 1 liter of water:

[0039] Citric acid 3.0g / L

[0040] Sodium citrate 35.0g / L

[0041] EDTA-Na 90g / L

[0042] Glucose 35.0g / L

[0043] Sodium dihydrogen phosphate 1.25g / L

[0044] Adenine 0.175g / L

[0045] 3) Fixative 1.5ml / 400ml blood

[0046] Wherein, fixative formulation is by volume ratio:

[0047] Ethanol: glutaraldehyde = 60ml: 2.2ml

[0048] 4) Protective agent 8ml / 400ml blood

[0049] Wherein, the protective agent formula is by weight of each component contained in 1 liter of water:

[0050] Aspirin 1.0g

[0051] Dipyridamole 0.6g

[0052] Penicillin - 26 million units

[0053] Firstly prepare the anti-aggregation agent, fixative and protective agent according to the above proportions, mix the three components ev...

Embodiment 3

[0055] Whole blood quality control substance formula of the present invention:

[0056] 1) Type B blood 400ml

[0057] 2) Anti-aggregation agent 80ml / 400ml blood

[0058] Wherein, antipolymerization agent formula is by weight of each component in 1 liter of water:

[0059] Citric acid 4.0g / L

[0060] Sodium citrate 32.0g / L

[0061] EDTA-Na 110g / L

[0062] Glucose 45.0g / L

[0063] Sodium dihydrogen phosphate 4.00g / L

[0064] Adenine 0.375g / L

[0065] 3) Fixative 10ml / 400ml blood

[0066] Wherein, fixative formulation is by volume ratio:

[0067] Ethanol: glutaraldehyde = 90ml: 3.0ml

[0068] 4) Protective agent 15ml / 400ml blood

[0069] Wherein, the protective agent formula is by weight of each component contained in 1 liter of water:

[0070] Aspirin 2.5g

[0071] Dipyridamole 0.8g

[0072] Penicillin - 20 million units

[0073] First, prepare anti-polymerization agent, fixative and protective agent respectively according to the above proportions, mix the three com...

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Abstract

The invention supplies a whole blood control material and the manufacture technology that includes blood, anti-assemble agent, fixative and protection agent. The match ratio is 30-80ml / 400ml, fixative 0.5-3.0ml / 400ml, and protection agent 3-15ml / 400ml. The producing method includes the following steps: mixing to equal, gathering healthy people blood, taking safety testing, filtering, mixing 15min taking subpackaging, fixing value and taking verifying to the fixing value, determining the bottle error to gain whole blood control material. The invention has long stationary phase, and simple technology. It is mainly used to verify blood.

Description

technical field [0001] The invention relates to a biological product reagent and a production process, in particular to a whole blood quality control substance and a production process. Background technique [0002] Whole blood quality control substance is a substance used for quality control in the process of blood cell analysis in clinical laboratories. It is mainly used for blood tests such as white blood cells, red blood cells, hemoglobin and platelets. At present, the production of whole blood quality control materials is mostly prepared with finished bank blood. The main components of maintenance bank blood are citric acid, sodium citrate, glucose, sodium dihydrogen phosphate, and adenine; the fixative is a single component glutaraldehyde , easy to cause platelet aggregation and changes in cell morphology, the maintenance time is generally 1 to 3 months, and the stability is poor. Chinese patent 1263200 discloses a hematological cell three-differentiation whole blood ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/48C12Q1/02
Inventor 杨慧王大平王保宁谭韬
Owner SICHUAN MACCURA BIOTECH CO LTD
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