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10名健康男性志愿者采用交叉给药方案，分别多剂量口服30mg国产和进口麦角溴烟酯纷释胶囊，用HPLC法测定代谢较快者血浆中麦角淇烟酯代谢产物Ⅱ（MDL）浓度，进行国产制剂生物利用度和生物等效性评价，其生物等效性采用方差分析和单侧t检验判定。结果表明：国产与进口胶囊达稳态后MDL血药浓度－时间曲线均符合一室模型，Cmax分别为47．41±9．77μg／L和47．88±8．46μg／L，AUC分别是754，60±96．77μg·h·L－1778．45±80．16μg·h·L-1，FI（峰谷波动）为1．70±0．05和1．68±0．08。国产麦角溴烟酯的相对生物利用度是96．94％，两种制剂的药代动力学参数经数理学统计，无显著性差异（P＞0．05）。
Ten healthy male volunteers were given oral administration of 30 mg domestic and imported nicergoline capsules in multiple doses. The metabolites of ergotgenol metabolite Ⅱ (MDL) in plasma were determined by HPLC. The domestic bioavailability and bioequivalence of the preparation were evaluated. The bioequivalence was evaluated by analysis of variance and one-sided t-test. The results showed that the plasma concentration-time curves of MDL of domestic and imported capsules were consistent with the one-compartment model with Cmax of 47.41 ± 9.77μg / L and 47.88 ± 8.46μg / L, respectively. The AUC were 754,60 ± 96.77μg · h · L-1778.45 ± 80.16μg · h · L-1, FI (peak-valley fluctuation) was 1.70 ± 0.05 and 1.68 ± 0.08. The relative bioavailability of domestic nicergoline was 96.94%. There was no significant difference (P> 0.05) between the pharmacokinetic parameters of the two formulations by mathematical statistics.