作者：夏延哲1，陈斯乐2，伍晶晶1，陈孝1，张信华2

单位：1. 中山大学附属第一医院 药学部，广东 广州 510080； 2. 中山大学附属第一医院 胃肠外科，广东 广州 510080

Authors:  XIA Yanzhe1, CHEN Sile2, WU Jingjing1, CHEN Xiao1, ZHANG Xinhua2

Unit:  1. Department of Pharmacy, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou 510080, Guangdong, China； 2. Department of Gastrointestinal Surgery, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou 510080, Guangdong, China

摘要：

目的  考察服用伊马替尼胃肠间质瘤患者的全血样本在室温下血浆药物浓度的稳定性。方法  采用LC/MS/MS方法，2 mmol·L-1甲酸铵溶液-乙腈(3:7)为流动相，以d8-伊马替尼为内标。取10名规律服用伊马替尼至少1月患者的无菌全血样本，室温分别放置0、6、12、24、48、72 h后提取血浆，进行检测。结果  10名患者均为胃肠间质瘤患者，男性7名，中位年龄52(35-62)岁，伊马替尼服药剂量300-400 mg/d，10例患者无菌全血样本室温放置0、6、12、24、48、72 h后测得结果的RSD均小于15%。结论  室温下伊马替尼的无菌全血样本放置72 h内血浆药物浓度稳定，全血样本室温放置3 d内检测结果可信。

关键词： 伊马替尼; 稳定性; 血浆药物浓度

Abstract：

Objective  To investigate the stability of imatinib in whole blood of gastrointestinal stromal tumor patients at room temperature. Methods  LC/MS/MS was performed, 2 mmol ▪L-1 ammonium formate solution and acetonitrile (3:7) as the mobile phase, d8-imatinib as the internal standard. The whole blood samples from 10 patients who were administrated imatinib at least one month, were maintained at room temperature in 0, 6, 12, 24, 48, 72 h respectively. Then the plasma contained imatinib from all the samples was extracted and detected. Results  10 patients were all diagnosed as gastrointestinal stromal tumors and administrated 300-400 mg imatinib per day, seven of them were male, the median age was 52 (35-62), intra-batch and inter-batch of different time RSDs were all <15%. Conclusion the plasma concentrations of imatinib were stable which were extracted from whole blood at room temperature in 72 h, suggesting the concentration of imatinib results were acceptable when whole blood samples were placed within 3 days at room temperature.

Key Words:  Imatinib; Stability; Plasma concentration