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  • 1
    Language: English
    In: Bioscience trends, 12 September 2017, Vol.11(4), pp.475-482
    Description: Cyclosporin A (CyA) is an immunosuppressive agent widely used in clinical therapy. In the therapeutic process, the blood concentration of CyA should be monitored to avoid or prevent rejection and toxicity. The objectives of this study were to compare the correlation of liquid chromatography-tandem mass spectrometry (LC-MS/MS) and enzyme-multiplied immunoassay technique (EMIT) for the determination of the CyA concentration in human blood and to provide evidence for the rational usage of EMIT in clinical practice. Blood samples collected from 132 patients undergoing a liver or kidney transplant or patients with aplastic anemia at Qilu Hospital of Shandong University were tested using the two methods. The calibration curve was linear from 25-500 ng·mL for LC-MS/MS and from 50-450 ng·mL for EMIT. The inter- and intra-day RSDs were less than 15%. The CyA blood concentration according to EMIT was 3.5 ng·mL more than that according to LC-MS/MS. The 95% confidence interval was -10.0~16.9 ng·mL. The CyA blood concentration according to the two methods did not differ significantly (p 〉 0.05). LC-MS/MS and EMIT were suitable methods for determining the CyA blood concentration. The two methods were closely correlated (r = 0.969), but the CyA blood concentration according to EMIT was slightly higher than that according to LC-MS/MS. The clinical significance of this finding needs to be further evaluated.
    Keywords: Cyclosporin A ; LC-MS/MS ; Comparison ; Enzyme-Multiplied Immunoassay Technique ; Therapeutic Drug Monitoring ; Asian Continental Ancestry Group ; Enzyme Multiplied Immunoassay Technique ; Chromatography, Liquid -- Methods ; Cyclosporine -- Blood ; Tandem Mass Spectrometry -- Methods
    ISSN: 18817815
    E-ISSN: 1881-7823
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  • 2
    Language: English
    In: Current Pharmaceutical Analysis, 2018, Vol.14(6), p.541-546
    Description: Background and Objectives: To establish a simple and reproducible High Performance Liquid Chromatography (HPLC) method for the determination of mizoribine in human plasma using glipizide as Internal Standard (IS). Methods: The mizoribine in plasma was precipitated with 10% perchloric acid and separated on a Phenomenex Luna NH2 (250 mm × 4.6 mm, 5 µm) column with a mobile phase consisted of acetonitrile and 0.3% glacial acetic acid aqueous solution (48:52, V/V) at a flow rate of 1.0 mL/min. The detection wavelength was 280 nm and the column temperature was room temperature. Results: The assay exhibited a linear range of 0.05-10.0 µg/mL (r = 0.9992) and the lower limit of quantification was 0.05 µg/mL. The specificity, linearity, accuracy, precision and stability were in accordance to China Food and Drug Administration (CFDA) guidelines. Conclusion: Therefore, the method was successfully applied in the routine therapeutic mizoribine monitoring in Chinese kidney transplant patients after an oral administration of 100 mg (2 Bredinin® 50 mg tablets) or 150 mg (3 Bredinin® 50 mg tablets) mizoribine.
    Keywords: Mizoribine Hplc Therapeutic Drug Monitoring Clinical Application Validation.
    ISSN: 1573-4129
    E-ISSN: 1875-676X
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