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目的建立人血浆中米氮平的HPLC-ESI-MS测定法,以测定志愿者口服米氮平片剂(30mg/片)后的血药浓度,并对受试制剂和参比制剂的生物等效性进行评价.方法20名健康志愿者交叉口服供试片和参比片,剂量均为30mg.采用HPLC-ESI-MS法测定人血浆中米氮平浓度.计算主要药动学参数及相对生物利用度.结果在0.3-200ng·mL-1范围内米氮平与内标峰面积比值与浓度线性关系良好,最低定量限为0.1ng·mL-1.受试制剂及参比制剂的生物半衰期分别为(24.7±4.1)h和(23.6±4.3)h,达峰时间分别为(1.6±0.8)和(1.5±0.8)h,峰浓度分别为(95.9±29.8)和(91.9±26.7)ng·mL-1.以AUC0-120计算的受试制剂的相对生物利用度为(100.0±10.8)%.结论本实验建立的人血浆中米氮平的HPLC-MS分析方法灵敏、准确、简便.统计学结果表明两种米氮平制剂生物等效.“,”Aim To establish a sensitive and specific liquid chromatography-mass spectrometry method for determination of mirtazapine in human plasma and evaluation of its relative bioavailability. Methods After being alkalized by 25 %ammonia, mirtazapine in the plasma was extracted with n-hexane. Desloratadine was used as internal standard (IS). Solutes were separated on a C18 column with a mobile phase of methanol-ammonium acetate buffer (pH 3.5) (75:25). The flow and operated in selected ion monitoring (SIM) and positive-ionization mode using target ionsatm/z 266.2 for mirtazapine and m/z 311.2 for the IS. The fragmentor voltage was 90 V. A randomized cross-over study was performed in 20 healthy volunteers. In the two study periods, twenty healthy Chinese male subjects received a single oral dose of mirtazapine 30 mg.mL-1 . The parameters for mirtazapine test tablet and reference tablet were as follows: T1/2 (24.7 + 4.1) and (23.6 +clusion The established HPLC-MS method is rapid, sensitive and specific for the determination of mirtazapine in human plasma. The relative bioavailahility was 100.0% ± 10.8%.