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Preparation and application of quality control substances of plasma type freeze-dried powder catecholamines and metabolites

A technology of catecholamine and freeze-dried powder, which is applied in the field of medical testing, can solve the problems of instability and difficult to store for a long time, and achieves the effect of good stability

Pending Publication Date: 2020-05-29
NINGBO MEDICAL SYSTEM BIOTECHNOLOGY CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The present invention aims at the problems of the above-mentioned prior art, by using human plasma as a substrate, it overcomes the shortcomings of unstable fresh plasma, frozen plasma catecholamines and metabolite quality control substances, and is not easy to store for a long time, and provides a homogeneity, stability Good plasma-type freeze-dried powder catecholamines and metabolites quality control substances

Method used

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  • Preparation and application of quality control substances of plasma type freeze-dried powder catecholamines and metabolites
  • Preparation and application of quality control substances of plasma type freeze-dried powder catecholamines and metabolites
  • Preparation and application of quality control substances of plasma type freeze-dried powder catecholamines and metabolites

Examples

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Effect test

example 1

[0042] Collect the plasma without jaundice, chyle, and hemolysis, and select samples with negative infectious disease screening results (HIV, hepatitis B, syphilis, and hepatitis C) to mix together, stir evenly, and set aside.

[0043] Take 150mL of the above-mentioned mixed plasma, weigh activated carbon according to the amount of 10g / 100mL, add it to the plasma, stir slowly for 2 hours, and then filter it with 0.45μm and 0.22μm filter membranes respectively to obtain clarified plasma. After testing the catecholamines and their metabolites The content is very low and can be ignored.

[0044] Contain dopamine 0.5nmol / L, epinephrine 2.5nmol / L, norepinephrine 10nmol / L, metanephrine and noradrenaline 1.5nmol / L in the prepared quality control product, according to dopamine, epinephrine, norepinephrine Calculate the volume of the standard stock solution that needs to be added according to the concentration of the standard stock solution of metanephrine, metanephrine, and norepineph...

example 2

[0046] Collect the plasma without jaundice, chyle, and hemolysis, and select samples with negative infectious disease screening results (HIV, hepatitis B, syphilis, and hepatitis C) to mix together, stir evenly, and set aside.

[0047] Take 150mL of the above mixed plasma, weigh 5.0g / 100mL of activated carbon, add it to the plasma, stir slowly for 4 hours, and then filter it with 0.45μm and 0.22μm filter membranes respectively to obtain clarified plasma. After testing the catecholamines and their metabolism content is very low and can be ignored.

[0048] Contain dopamine 1.0nmol / L, epinephrine 4.0nmol / L, norepinephrine 20nmol / L, metanephrine and noradrenaline 2.0nmol / L in the prepared quality control product, according to dopamine, epinephrine, norepinephrine Calculate the volume of the standard stock solution that needs to be added according to the concentration of the standard stock solution, plasma volume (according to 100mL) and quality control substance, add the processe...

example 3

[0050] Collect anicteric, chyle, and hemolyzed plasma, and select samples with negative infectious disease screening results (HIV, hepatitis B, syphilis, and hepatitis C) to mix together, stir evenly, and set aside.

[0051] Take 150mL of the above-mentioned mixed plasma, weigh 7.5g / 100mL of activated carbon, add it to the plasma, stir slowly for 3 hours, and then filter it with 0.45μm and 0.22μm filter membranes respectively to obtain clarified plasma. After testing the catecholamines and their metabolism content is very low and can be ignored.

[0052] Contain dopamine 1.5nmol / L, epinephrine 6.0nmol / L, norepinephrine 40nmol / L, metanephrine and noradrenaline 3.0nmol / L in the prepared quality control product, according to dopamine, epinephrine, norepinephrine Calculate the volume of the standard stock solution that needs to be added according to the concentration of the standard stock solution, plasma volume (according to 100mL) and quality control substance, add the processed...

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Abstract

The invention relates to preparation and application of a quality control substances of plasma type freeze-dried powder catecholamines and metabolites, and the substance is prepared by the following main steps: collecting clinical fresh plasma-free for infectious disease screening, selecting samples with negative screening results, and mixing together for later use; adsorbing catecholamine substances and metabolites in the plasma by adopting activated carbon to obtain blank plasma; adding a standard stock solution of catecholamines and metabolites thereof into the blank plasma, and uniformly stirring; adding a stabilizer, an excipient, an antioxidant and a preservative into the plasma, and stirring until the components are completely dissolved; and sub-packaging the obtained plasma by using ampoule bottles according to specification requirements, and freeze-drying to prepare freeze-dried powder. The method can overcome the defects that catecholamine substances and metabolite quality control substances in fresh plasma and frozen plasma are unstable and are not easy to store for a long time and has the advantages of good uniformity and stability.

Description

technical field [0001] The invention relates to the technical field of medical testing, in particular to the preparation and application of quality control substances of plasma-type freeze-dried powder catecholamines and their metabolites. Background technique [0002] Catecholamines (CAs) are important information transmission substances of the human central nervous system, participate in, maintain and regulate the nervous system, and are endogenous substances with strong physiological activities in organisms. Monoamine neurotransmitter synthesized and secreted by chromium plays an important role in brain and nerve signal transduction. Catecholamines mainly include norepinephrine (Norepinephrine, NE), epinephrine (Epinephrine, E), isoproterenol and dopamine (Dopamine, DA). [0003] The chemical structure of catecholamines contains a dihydroxybenzene ring and a side chain with an amino group, which is highly polar and easily soluble in water. The catechol structure is relat...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/72
CPCG01N30/02G01N30/06G01N30/72
Inventor 邹继华沈敏古咏梅杨晓东李全乐屠敏敏邹炳德
Owner NINGBO MEDICAL SYSTEM BIOTECHNOLOGY CO LTD
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