Kit for accurately determining concentration of four kinds of immunosuppressant type medicine in human whole blood and detecting method

An immunosuppressive, accurate measurement technology, applied in the field of medical testing, can solve the problem of difficult traceability of detection methods, and achieve the effects of small sample size, short time and high sensitivity

Inactive Publication Date: 2019-03-01
NINGBO MEDICAL SYSTEM BIOTECHNOLOGY CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, mass spectrometry clinical testing methods are all established by the laboratory (laboratory developed tests, LDT). , repeatability, and time comparability need further clinical verification

Method used

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  • Kit for accurately determining concentration of four kinds of immunosuppressant type medicine in human whole blood and detecting method
  • Kit for accurately determining concentration of four kinds of immunosuppressant type medicine in human whole blood and detecting method
  • Kit for accurately determining concentration of four kinds of immunosuppressant type medicine in human whole blood and detecting method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0077] A kit for determining the concentrations of four immunosuppressant drugs in human whole blood, including

[0078] Contains calibrators with six concentration gradients, and the calibrators of each concentration gradient are lyophilized powders of methanol solutions of tacrolimus, sirolimus, everolimus and cyclosporine A;

[0079] Among them, the six concentration points of tacrolimus, sirolimus, and everolimus are the same, in order: 2ng / mL, 5ng / mL, 10ng / mL, 20ng / mL, 50ng / mL, 100ng / mL; The six concentrations of sporomycin A are 10ng / mL, 50ng / mL, 200ng / mL, 500ng / mL, 1000ng / mL, 2000ng / mL;

[0080] Internal standard: internal standard solution is containing tacrolimus- 13 Cd 2 , sirolimus-d 3 , everolimus-d 4 and cyclosporine A-d 4 methanol solution, in which tacrolimus- 13 Cd 2 , sirolimus-d 3 and everolimus-d 4 The concentration in the internal standard solution is 10ng / mL; cyclosporine A-d 4 The concentration in the internal standard solution is 200ng / mL;

[...

Embodiment 2

[0103] A kit for determining the concentrations of four immunosuppressant drugs in human whole blood, including

[0104] Contains calibrators with six concentration gradients, and the calibrators of each concentration gradient are lyophilized powders of methanol solutions of tacrolimus, sirolimus, everolimus and cyclosporine A;

[0105] Among them, the six concentration points of tacrolimus, sirolimus, and everolimus are the same, in order: 2ng / mL, 5ng / mL, 10ng / mL, 20ng / mL, 50ng / mL, 100ng / mL; The six concentrations of sporomycin A are 10ng / mL, 50ng / mL, 200ng / mL, 500ng / mL, 1000ng / mL, 2000ng / mL;

[0106] Internal standard: internal standard solution is containing tacrolimus- 13 Cd 2 , sirolimus-d 3 , everolimus-d 4 and cyclosporine A-d 4 methanol solution, in which tacrolimus- 13 Cd 2 , sirolimus-d 3 and everolimus-d 4 The concentration in the internal standard solution is 10ng / mL; cyclosporine A-d 4 The concentration in the internal standard solution is 200ng / mL;

[...

Embodiment 3

[0116] A kit for determining the concentrations of four immunosuppressant drugs in human whole blood, including

[0117] Contains calibrators with six concentration gradients, and the calibrators of each concentration gradient are lyophilized powders of methanol solutions of tacrolimus, sirolimus, everolimus and cyclosporine A;

[0118] Among them, the six concentration points of tacrolimus, sirolimus, and everolimus are the same, in order: 2ng / mL, 5ng / mL, 10ng / mL, 20ng / mL, 50ng / mL, 100ng / mL; The six concentrations of sporomycin A are 10ng / mL, 50ng / mL, 200ng / mL, 500ng / mL, 1000ng / mL, 2000ng / mL;

[0119] Internal standard: internal standard solution is containing tacrolimus- 13 Cd 2 , sirolimus-d 3 , everolimus-d 4 and cyclosporine A-d 4 methanol solution, in which tacrolimus- 13 Cd 2 , sirolimus-d 3 and everolimus-d 4 The concentration in the internal standard solution is 10ng / mL; cyclosporine A-d 4 The concentration in the internal standard solution is 200ng / mL;

[...

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Abstract

The invention provides a kit for accurately determining the concentration of four kinds of immunosuppressant type medicine in human whole blood. The kit comprises Tacrolimus (TAC), sirolimus (SIR), everolimus (EVR) and cyclosporine A (CsA) calibrators, Tacrolimus-<13>Cd2, sirolimus-d3, everolimus-d4 and cyclosporine A-d4 interior labels, quality control products of Tacrolimus, sirolimus, everolimus and cyclosporine A, sample treatment liquid, extraction liquid, flowing phases and redissolution solution. The kit is used for treating whole blood samples; by a simple protein precipitation-liquidliquid extraction pretreatment method, clean treatment liquid can be obtained without complicated purification and refinement steps; the required sample quantity is small; the kit can be used by beingmatched with a liquid chromatograph tandom mass spectrometer; meanwhile, the kit can be used for simultaneously detecting four kinds of different immunosuppressant type medicine; the single sample multi-index synchronous detection can be realized; the detection specificity is high; the sensitivity is high; the whole detection flow process time is short; the flux is great; the cost is low.

Description

technical field [0001] The invention relates to the technical field of medical testing, in particular to a mass spectrometry kit and a liquid chromatography tandem mass spectrometry detection method for measuring the concentration of immunosuppressant drugs in human whole blood. Background technique [0002] Immunosuppressants are mainly used clinically in anti-graft rejection, treatment of autoimmune diseases and allergic diseases, etc. These drugs have a narrow therapeutic window and large individual differences in pharmacokinetics, requiring therapeutic drug monitoring (TDM). In recent years, statistics from the World Health Organization (WHO) and the Adverse Drug Reaction Monitoring Center of the Ministry of Health of my country have shown that the number of deaths due to improper medication is much higher than the number of deaths from various infectious diseases in the same period. Among those who died from improper medication, most of them were caused by improper dos...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/045
Inventor 邹继华沈敏杨晓东潘清清王琳李全乐邹炳德
Owner NINGBO MEDICAL SYSTEM BIOTECHNOLOGY CO LTD
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