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目的:建立高效液相色谱(HPLC)法测定人血浆中紫杉醇、多西紫杉醇浓度为临床个体化给药方案、疗效及不良反应评价提供实验依据。方法:紫杉醇和多西紫杉醇互为内标,血浆样品采用乙腈提取法,以Dik MA Diamonsil C18反相色谱柱分离样品,流动相为乙腈∶水(55∶45),检测波长为227 nm,流速为1.2 ml·min-1,柱温为25℃。结果:紫杉醇和多西紫杉醇血药浓度在0.078~10.0 mg·L-1范围内线性关系良好;最低定量下限为0.039 mg·L-1;平均方法回收率分别为99.85%和100.35%;日内、日间相对标准差均低于5%;短期稳定性、长期稳定性和反复冻融稳定性相对标准差均低于10%。紫杉醇临床样本血浆药物浓度监测结果范围为0.18~6.16 mg·L-1,临床监测结果存在明显个体差异。结论:紫杉醇和多西紫杉醇血浆药物浓度差异明显,进行两药治疗药物监测十分必要。本方法灵敏、准确、便捷、快速,适用于紫杉醇和多西紫杉醇的临床常规治疗药物监测及药动学研究。
OBJECTIVE: To establish an HPLC method for the determination of paclitaxel and docetaxel in human plasma for clinical individualized administration, efficacy and adverse reaction evaluation. METHODS: Paclitaxel and docetaxel were used as internal standards. The plasma samples were extracted by acetonitrile. The samples were separated on a Dik MA Diamonsil C18 reversed-phase column. The mobile phase consisted of acetonitrile: water (55:45), detection wavelength was 227 nm, flow rate 1.2 ml · min-1, the column temperature was 25 ℃. Results: The linearity of the concentration of paclitaxel and docetaxel in the range of 0.078-10.0 mg · L-1 was good. The lowest limit of quantification was 0.039 mg · L-1. The average recoveries were 99.85% and 100.35% Day relative standard deviations were less than 5%; short-term stability, long-term stability and repeated freeze-thaw stability of the relative standard deviation of less than 10%. The plasma concentration of paclitaxel in clinical samples ranged from 0.18 to 6.16 mg · L-1, with significant individual differences in clinical monitoring results. Conclusion: The difference of plasma drug concentration between paclitaxel and docetaxel is obvious. It is very necessary to monitor the two drugs. The method is sensitive, accurate, convenient and rapid, and is suitable for the monitoring and pharmacokinetic study of routine therapeutic drugs of paclitaxel and docetaxel.