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采用体积吸收微取样法对人全血中磷霉素进行定量生物分析验证。

Quantitative bioanalytical validation of fosfomycin in human whole blood with volumetric absorptive microsampling.

作者信息

Parker Suzanne L, Roberts Jason A, Lipman Jeffrey, Wallis Steven C

机构信息

Burns, Trauma & Critical Care Research Centre, The University of Queensland, Brisbane, Australia.

Department of Pharmacy, Royal Brisbane & Women's Hospital, Brisbane, Australia.

出版信息

Bioanalysis. 2015 Oct;7(19):2585-95. doi: 10.4155/bio.15.173. Epub 2015 Oct 16.

Abstract

BACKGROUND

Fosfomycin is an antibiotic of considerable interest for the treatment of infection by multidrug-resistant bacteria. Translating microsampling techniques into clinical PK studies may provide effective dosing information to improve patient outcomes and minimize the potential development of resistance.

RESULTS

Accuracy and precision results were within ±15%; the method was validated across the range of 5-2000 µg/ml of fosfomycin using volumetric absorptive microsampling (VAMS) devices.

CONCLUSION

The VAMS techniques provide acceptable validation data as assessed for lower limit of quantification, linearity, intra- and interday precision and accuracy, selectivity and matrix effects. Results from the recovery and stability studies suggest challenges remain for the analysis of fosfomycin in whole blood using VAMS.

摘要

背景

磷霉素是一种在治疗多重耐药菌感染方面备受关注的抗生素。将微量采样技术应用于临床药代动力学研究可能会提供有效的给药信息,以改善患者预后并最大限度地减少耐药性的潜在发展。

结果

准确度和精密度结果在±15%以内;该方法使用体积吸收微量采样(VAMS)装置在5 - 2000 µg/ml的磷霉素浓度范围内得到验证。

结论

VAMS技术在定量下限、线性、日内和日间精密度与准确度、选择性和基质效应方面的评估提供了可接受的验证数据。回收率和稳定性研究结果表明,使用VAMS分析全血中的磷霉素仍存在挑战。

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