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5-FU在全血中的稳定性及其TDM临床采样转运流程研究
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| 篇名： | 5-FU在全血中的稳定性及其TDM临床采样转运流程研究 |
| TITLE： | Stability of 5-FU in whole blood and a clinical sampling and delivery procedures for TDM |
| 摘要： | 目的 考察5-氟尿嘧啶（5-FU）在人全血中的稳定性，并以此为依据建立标准化的5-FU治疗药物监测（TDM）临床采样转运流程。方法以EDTA抗凝全血样本为基质制备低（200ng/mL）、高（5000ng/mL）浓度的5-FU全血稳定性考察样品（分别设置无稳定剂组与添加1%体积比的稳定剂组）。将全血稳定性考察样品分别置于室温（[25±2）℃]及冷藏（2～8℃）条件下，于0、0.5、1、2、4、7、24h时间点取样处理，样品经涡旋、离心后取上层血浆，采用甲醇沉淀蛋白后，通过高效液相色谱-串联质谱法测定血浆中5-FU的浓度。基于全血稳定性考察结果制定临床采样转运流程。结果未添加稳定剂的空白全血样品中5-FU的浓度显著低于添加了稳定剂的样品（P＜0.05），而不同体积（10、25、50μL）稳定剂对低、高浓度全血稳定性考察样品中5-FU的浓度测定结果均无显著影响（P＞0.05）。未添加稳定剂时，低、高浓度的5-FU全血样品在室温下分别可稳定保存0.5h与1h，冷藏条件下分别可稳定保存2h与7h；添加1%体积比的稳定剂后，全血样品在室温与冷藏条件下均可稳定保存24h。所建5-FUTDM临床采样转运流程为：采样后将全血样本在室温（≤0.5h）或4℃（≤2h）条件下暂存，并于2～8℃冷藏转运；送达实验室后立即添加1%体积比的稳定剂，并于24h内完成离心，所得血浆于－20℃保存。结论全血中的5-FU在室温条件下稳定性较差，2～8℃冷藏时稳定性略有提升但仍会快速降解；添加1%体积比的稳定剂可显著延长其冷藏保存时间。本研究所建5-FUTDM临床采样转运流程，创新性地将稳定剂添加节点设置于样品接收环节（而非采血后立即添加），在保证样品分析质量的前提下，更贴合临床采血的实际操作条件，显著提升了临床实际操作的可行性。 |
| ABSTRACT： | OBJECTIVE To investigate the stability of 5-fluorouracil （5-FU） in human blood and to establish a standardized clinical sampling and delivery procedure for therapeutic drug monitoring （TDM） of 5-FU. METHODS The EDTA-anticoagulated whole blood was used as the matrix to prepare stability assessment samples of 5-FU at both low （200 ng/mL） and high （5 000 ng/mL） concentrations （with groups without stabilizer and with 1% volume ratio of stabilizer）. The stability assessment samples were placed under room temperature （[ 25±2） ℃] and refrigerated （2-8 ℃） conditions， with sampling at 0， 0.5， 1， 2， 4， 7， and 24 h. After vortexing and centrifugation， the upper plasma layer was collected； proteins were precipitated using methanol， and the concentration of 5-FU in plasma was determined by liquid chromatography-tandem mass spectrometry. Based on the whole blood stability results， clinical sampling and delivery procedures were established. RESULTS The concentration of 5-FU in blank whole blood samples without stabilizers was significantly lower than that in samples with stabilizers （P＜0.05）. However， varying volumes （10， 25， 50 μL） of stabilizers had no significant effect on the measured concentrations of 5-FU in stability assessment samples with low and high concentrations （P＞0.05）. Without the addition of a stabilizer， low- and high-concentration 5-FU whole blood samples remained stable at room temperature for 0.5 h and 1 h， respectively， and under refrigeration for 2 h and 7 h， respectively. After the addition of a 1% stabilizer， the whole blood samples remained stable for up to 24 h under both room temperature and refrigerated conditions. Based on these findings， the following procedure was established： after collection， whole blood samples could be temporarily stored at room temperature （≤0.5 h） or at 4 ℃ （≤2 h）， and transported at 2-8 ℃. Upon delivery to the laboratory， a 1% volume ratio of stabilizer must be added immediately， followed by centrifugation within 24 h. The resulting plasma should be stored at －20 ℃ . CONCLUSIONS 5-FU in whole blood exhibits poor stability at room temperature. Refrigeration at 2-8 ℃ slightly improves stability ， but degradation still occurs rapidly. Adding a stabilizer at a 1% volume ratio significantly prolongs the refrigerated storage time. The established sampling and transport procedure for 5-FU TDM innovatively introduces the stabilizer addition step at the laboratory sample reception stage （rather than immediately after blood draw）. This approach ensures analytical quality while offering greater adaptability to real-world clinical sampling conditions， significantly improving practical feasibility. |
| 期刊： | 2025年第36卷第23期 |
| 作者： | 温永青；王文娟；白羽；刘汝峰；马旭 |
| AUTHORS： | WEN Yongqing，WANG Wenjuan，BAI Yu，LIU Rufeng，MA Xu |
| 关键字： | 5-氟尿嘧啶；全血；稳定性；治疗药物监测；临床采样转运流程 |
| KEYWORDS： | 5-fluorouracil； whole blood； stability； therapeutic drug monitoring； clinical sampling and delivery procedures |
| 阅读数： | 3 次 |
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