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目的评价2种国产尼美舒利颗粒在中国健康人体的生物等效性。方法20名健康男性受试者随机交叉单剂量口服试验药物或对照药物,各100 mg。用高效液相色谱法测定血浆中尼美舒利浓度;用DAS 2.1软件计算主要药代动力学参数,并对2种药物进行生物等效性评价。结果试验药物和对照药物的主要药代动力学参数:Cmax分别为(6.67±1.80)和(6.50±1.72)μg.mL-1;Tmax分别为(1.88±0.81)和(2.25±0.66)h;t1/2分别为(2.99±0.72)和(2.70±0.58)h;AUC0-24分别为(33.67±12.16)和(33.93±12.99)μg.h.mL-1。AUC0-24、AUC0-∞、Cmax的90%可信区间分别为86.2%～116.3%,86.6%～116.7%和86.8%～120.7%。试验药物相对于对照药物的生物利用度F为(106.9±40.2)%。结论试验药物和对照药物生物等效。
Objective To evaluate the bioequivalence of two domestic nimesulide granules in healthy Chinese. Methods Twenty healthy male subjects were randomized to receive a single oral dose of test or control drug, 100 mg each. The concentration of nimesulide in plasma was determined by HPLC. The main pharmacokinetic parameters were calculated by DAS 2.1 software and the bioequivalence of the two drugs was evaluated. Results The main pharmacokinetic parameters of the test drug and the control drug were Cmax 6.67 ± 1.80 and 6.50 ± 1.72 μg.mL-1, respectively; the Tmax values were (1.88 ± 0.81) and (2.25 ± 0.66) h respectively; t1 / 2 were (2.99 ± 0.72) and (2.70 ± 0.58) h respectively; AUC0-24 was (33.67 ± 12.16) and (33.93 ± 12.99) μg.h.mL-1 respectively. The 90% confidence intervals of AUC0-24, AUC0-∞ and Cmax were 86.2% -116.3%, 86.6% -116.7% and 86.8% -120.7%, respectively. The bioavailability F of the test drug relative to the control drug was (106.9 ± 40.2)%. Conclusion The test drug and control drug are bioequivalent.