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10名健康志愿者随机交叉给药,分别口服20mg国产盐酸西替利嗪胶囊和进口片剂进行药代动力学和相对生物利用度研究。采用高效液相色谱法,测定血浆中盐酸西替利嗪的浓度,经3p97生物利用度和生物等效性计算程序处理拟合,符合二室模型,并得国产胶囊和进口片剂的AUC分别为6842.10±962.24μg·h·L -1和7092.62±829.85μg·h·L -1,Tmax 分别为1.72±0.09h和1.54±0.09h,Cmax分别为954.29±76.88μg·L-1 和933.37±84.17μg·L-1,经配对t检验,两者的AUC,Tmax,Cmax 均无显著性差异(P>0.05)。采用梯形法计算的国产胶囊与进口片剂的AUC0 -t 分别为7077.02±1004.14μg·h·L-1 和7133.59±658.15μg·h·L-1,经方差分析和双单侧检验结果表明两者具有生物等效性。国产盐酸西替利嗪胶囊的相对生物利用度为99.0 %±7.2 %。
Ten healthy volunteers were randomized to receive oral administration of 20 mg domestic cetirizine hydrochloride capsules and imported tablets for pharmacokinetics and relative bioavailability. The plasma concentration of cetirizine hydrochloride was determined by high performance liquid chromatography (HPLC). The 3p97 bioavailability and bioequivalence calculation program were used to fit and fit the two-compartment model. The AUC of domestic capsules and imported tablets Were 6842.10 ± 962.24μg · h · L -1 and 7092.62 ± 829.85μg · h · L -1, the Tmax were 1.72 ± 0.09h and 1.54 ± 0.09h, the Cmax were 954.29 ± 76.88μg · L-1 and 933.37 ± 84.17 μg · L-1. There was no significant difference in AUC, Tmax and Cmax between the two groups (P> 0.05) by paired t-test. The AUC0-t of domestic capsules and imported tablets calculated by trapezoidal method were 7077.02 ± 1004.14μg · h · L-1 and 7133.59 ± 658.15μg · h · L-1, respectively. The analysis of variance and double unilateral test showed that the two Have bioequivalence. The relative bioavailability of domestic cetirizine hydrochloride capsules was 99.0% ± 7.2%.