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对9名男性健康志愿者空腹口服单剂量的二种萘呋胺缓释胶囊剂后的生物利用度进行了比较。萘呋胺血药浓度的测定采用专一、灵敏的反相HPLC-荧光检测法。有关药代参数的计算采用3P87药代程序按统计矩模式进行。统计结果表明二种胶囊的AUC、MRT、Cax、Tmax等药代参数无显著性差异,生物等效性检验合格。
The bioavailability of two nafuvastatin sustained-release capsules in a single dose of fasting oral solution to nine male healthy volunteers was compared. Naphthafuril plasma concentration determination using a dedicated, sensitive reverse phase HPLC-fluorescence detection method. The calculation of the pharmacokinetic parameters using 3P87 drug substitution procedures based on statistical moments mode. The statistical results showed that there was no significant difference in the pharmacokinetic parameters such as AUC, MRT, Cax and Tmax between the two capsules, and the bioequivalence test was qualified.