Whole blood type freeze-dried powder immunosuppressant quality control substance as well as preparation method and application thereof

An immunosuppressant, freeze-dried powder technology, applied in the field of medical testing, can solve the problems of unsuitable long-term storage, lack of ultra-low temperature storage devices, etc., and achieve the effect of good stability

Pending Publication Date: 2020-10-30
NINGBO MEDICAL SYSTEM BIOTECHNOLOGY CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although human whole blood can be directly used as a quality control substance for clinical monitoring of immunosuppressants,

Method used

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  • Whole blood type freeze-dried powder immunosuppressant quality control substance as well as preparation method and application thereof
  • Whole blood type freeze-dried powder immunosuppressant quality control substance as well as preparation method and application thereof
  • Whole blood type freeze-dried powder immunosuppressant quality control substance as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0047] Collect whole blood without jaundice, chyle, and hemolysis, select the whole blood samples with negative infectious disease screening results (HIV, hepatitis B, syphilis, hepatitis C) for blood type testing, and select 100mL of type A blood to mix evenly for quality control Product preparation; add 5g of PVP40, stir until completely dissolved; add 0.5g of tert-butanol, stir until completely dissolved.

[0048] After testing, the whole blood does not contain cyclosporine A, tacrolimus, sirolimus, and everolimus, and the prepared quality control product contains cyclosporine A 35ng / mL, tacrolimus, sirolimus Limus and everolimus 6ng / mL, to which an appropriate amount of standard stock solution needs to be added.

[0049] According to the concentration of tacrolimus, sirolimus, and everolimus standard stock solution, the volume of whole blood, and the concentration requirements of quality control products, calculate the volume of the standard stock solution that needs to be...

example 2

[0051] Collect whole blood without jaundice, chyle, and hemolysis, and select whole blood samples with negative infectious disease screening results (HIV, hepatitis B, syphilis, hepatitis C) to mix, add 20mg EDTA-K 2 Stir until completely dissolved, add 10g of PVP40, stir until completely dissolved; add 2.5g of tert-butanol, stir until completely dissolved.

[0052] After testing, the whole blood does not contain cyclosporine A, tacrolimus, sirolimus, and everolimus, and the prepared quality control product contains cyclosporine A 50ng / mL, tacrolimus, sirolimus Limus and everolimus 10ng / mL, to which an appropriate amount of standard stock solution needs to be added.

[0053] According to the concentration of tacrolimus, sirolimus, and everolimus standard stock solutions, the volume of whole blood, and the concentration requirements of quality control substances, calculate the volume of the standard stock solution that needs to be added, and pipette it to a clean In the beaker...

example 3

[0055] Collect whole blood without jaundice, chyle, and hemolysis, select the whole blood samples with negative infectious disease screening results (HIV, hepatitis B, syphilis, hepatitis C) and mix them, add 113mg of heparin and stir until completely dissolved, add 10g of PVP40, and stir until Dissolve completely; add 2.5g of tert-butanol and stir until completely dissolved.

[0056] After testing, the whole blood does not contain cyclosporine A, tacrolimus, sirolimus, and everolimus, and the quality control product contains cyclosporine A 100ng / mL, tacrolimus, sirolimus Limus and everolimus 20ng / mL, to which an appropriate amount of standard stock solution needs to be added.

[0057]According to the concentration of tacrolimus, sirolimus, and everolimus standard stock solution, the volume of whole blood, and the concentration requirements of quality control products, calculate the volume of the standard stock solution that needs to be added, and pipette it to a clean In the...

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Abstract

The invention discloses a whole blood type freeze-dried powder immunosuppressant quality control substance as well as a preparation method and application thereof. The substance is a freeze-dried product mainly prepared from human whole blood serving as a matrix and an immunosuppressant. The immunosuppressant comprises one or more of tacrolimus, sirolimus, everolimus and cyclosporin A, or furthercomprises glucocorticoid immunosuppressants: one or more of hydrocortisone, cortisone, prednisolone, prednison and mycophenolic acid ester immunosuppressants for blood detection. The substance has theadvantages that the uniformity and the stability are good, low-temperature storage at -70 DEG C is not needed, and the substance can be used as a calibration product of immunosuppressant kits of different methodologies and can also be used as a quality control product for clinically monitoring an immunosuppressant detection system.

Description

technical field [0001] The invention relates to the technical field of medical testing, in particular to a whole blood type freeze-dried powder immunosuppressant quality control substance and its preparation method and application. Background technique [0002] Immunosuppressants have an inhibitory effect on the body's immune response, can inhibit the proliferation and function of T cells, B cells and other macrophages in the body, reduce the antibody immune response, and play an extremely important role in the prevention and treatment of organ transplant rejection. It can also be used to treat autoimmune diseases and allergic diseases, etc. This type of drug has strong nephrotoxicity, narrow therapeutic window, and large individual differences in pharmacokinetics. Clinically, therapeutic drug monitoring (TDM) should be performed on patients to ensure that the use of immunosuppressants is within a safe and effective therapeutic range. , and not easily poisoned. [0003] Im...

Claims

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Application Information

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IPC IPC(8): G01N33/96
CPCG01N33/96G01N33/9493
Inventor 邹继华沈敏古咏梅杨晓东屠敏敏邹炳德
Owner NINGBO MEDICAL SYSTEM BIOTECHNOLOGY CO LTD
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