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采用高效液相色谱法进行国产尼美舒利(nimesulide)的药代动力学和相对生物利用度试验研究。4对正常志愿者分别随机口服国产和进口尼美舒利200mg,半月后再交叉给药。结果发现,国产,进口制剂在体内血药浓度-时间曲线均符合-室模型。国产尼美舒利主要药代动力学参数分别为T(ke)5.57±0.88h,Tpeak3.88±0.88h,AUC373.7±69.9mg·L~(-1)·h~(-1),C_(max)33.0±8.9mg/l。其相对生物利用度为:86.5%。本试验结果表明,国产与进口尼美舒利之间的药代动力学参数无明显差异。
The pharmacokinetics and relative bioavailability of nimesulide were studied by high performance liquid chromatography (HPLC). 4 pairs of normal volunteers were randomly oral domestic and imported nimesulide 200mg, after a half months and then cross-administered. The results showed that domestic and imported preparations in vivo blood concentration-time curves are in line with - room model. The main pharmacokinetic parameters of domestic nimesulide were T (ke) 5.57 ± 0.88h, Tpeak 3.8 ± 0.88h, AUC373.7 ± 69.9mg · L -1 · h ~ (-1), C max (max) 33.0 ± 8.9 mg / l. The relative bioavailability was 86.5%. The test results show that there is no significant difference in the pharmacokinetic parameters between domestic and imported nimesulide.