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目的建立测定人血浆中替米沙坦的液质联用方法。方法采用乙腈直接沉淀血浆蛋白后由ODS柱分离,质谱检测器测定。结果该方法的线性范围为2~500μg.L-1(r=0.999 2),方法回收率在95.8%~105.2%之间,日内和日间精密度都<10%。采用自身对照交叉试验,单剂量分别给予20名男性健康志愿者2种国产替米沙坦片40 mg,其主要药动学参数ρmax为(220.70±95.80)和(233.11±105.52)μg.L-1,AUC0→96为(1 908.54±650.43)和(1 986.26±553.24)μg.h.L-1,t1/2为(24.1±4.2)和(24.8±3.8)h;tmax为(1.8±0.6)和(1.7±0.7)h。结论两种制剂间的主要动力学参数无明显差异,为生物等效制剂,其相对生物利用度为(95.6±6.4)%。
Objective To establish a method for the determination of telmisartan in human plasma. Methods Direct separation of plasma proteins by acetonitrile followed by separation by ODS column was performed with mass spectrometry detector. Results The linear range of this method was 2 ~ 500μg.L-1 (r = 0.999 2). The recoveries of the method ranged from 95.8% to 105.2%. The intra- and inter-day precision was less than 10%. The self-controlled crossover test was conducted in a single dose of 20 mg of domestic telmisartan in 20 male healthy volunteers. The main pharmacokinetic parameters ρmax were (220.70 ± 95.80) and (233.11 ± 105.52) μg.L- 1, AUC0 → 96 was (1 908.54 ± 650.43) and (1 986.26 ± 553.24) μg.hL-1, t1 / 2 was (24.1 ± 4.2) and (24.8 ± 3.8) (1.7 ± 0.7) h. Conclusion There is no significant difference in the main kinetic parameters between the two preparations. The relative bioavailability of the two preparations is bioequivalent (95.6 ± 6.4)%.