论文部分内容阅读
8名健康志愿者交叉口服500mg国产阿奇霉素颗粒剂和进口胶囊剂，对国产与进口制剂的生物等效性进行了研究。血药浓度采用微生物法进行测定。结果表明：口服国产和进口两种制剂的血药浓度一时间曲线均符合二室模型，Cmax分别为0．4±0．036与0．427±0．038mg／L，Tmax为2．07±0．16与2．03±0．13h，t1／2β为47．29±3．25与48．46±1．99h，AUC为7．28±0．48与7．33±0．66mg·h／L。比较两种制剂的药代动力学参数均无显著性差异（P＞0．05）。国产阿奇霉素颗粒剂的相对生物利用度为99．70％，两种制剂生物等效。本项研究将为国产阿奇霉素颗粒剂的临床应用提供指标和依据。
Eight healthy volunteers orally taking 500mg domestic azithromycin granules and imported capsules, the bioavailability of domestic and imported preparations were studied. Blood concentration was determined by the microbial method. The results showed that the two curves of plasma concentrations of both domestic and imported preparations accord with the two-compartment model with Cmax of 0.4 ± 0.036 and 0.427 ± 0.038 mg / L, respectively, and the Tmax of 2.07 ± 0.16 and 2.03 ± 0.13 h, t1 / 2β was 47.29 ± 3.25 and 48.46 ± 1.99 h, AUC was 7.28 ± 0.48 and 7.33 ± 0.66 mg · h / L. There was no significant difference in the pharmacokinetic parameters between the two preparations (P> 0.05). The relative bioavailability of domestic azithromycin granules was 99.70%, and both formulations were bioequivalent. This study will provide indicators and basis for the clinical application of domestic azithromycin granules.