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目的建立替米沙坦血药浓度的HPLC-FLU测定法,用于人体生物等效性研究。方法采用单剂量双交叉实验设计,用HPLC-FLU法测定20名健康受试者口服两种替米沙坦片剂40mg后的血药浓度。结果受试制剂和参比制剂药-时曲线均符合一房室模型,cmax为(225.70±99.20)和(238.11±102.17)μg/L,tmax为(1.8±0.7)和(1.7±0.8)h,t1/2为(24.5±4.7)和(24.9±3.9)h,AUC为(1938.22±557.12)和(1998.26±593.34)μg/(h·L),受试制剂的相对生物利用度为96.6(5.3%。结论经统计学分析,两种片剂具有生物等效性。
OBJECTIVE To establish a HPLC-FLU assay for determining the concentration of telmisartan for bioequivalence studies in humans. Methods The single-dose, double-crossover design was used to determine the plasma concentrations of 40 mg of two telmisartan tablets in 20 healthy volunteers by HPLC-FLU. Results The drug-time curves of the test preparations and the reference preparations were in accordance with one-compartment model with cmax of (225.70 ± 99.20) and (238.11 ± 102.17) μg / L and tmax of (1.8 ± 0.7) and (1.7 ± 0.8) h (24.5 ± 4.7) and (24.9 ± 3.9) h for t1 / 2, AUC of (1938.22 ± 557.12) and (1998.26 ± 593.34) μg / (h · L), respectively, and the relative bioavailability of the test preparation was 96.6 5.3%. CONCLUSIONS By statistical analysis, the two tablets are bioequivalent.