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目的 :评价国产和进口阿那曲唑片的生物等效性。方法 :2 0名受试者随机分成 2组 ,交叉口服试验品与对照品各 1片 (1mg× 1片 ) ,用气相色谱法测定血药浓度。方法线性范围为 0 .5～ 2 0 0 .0μg·L- 1血浆 (r =0 .9997,n =90 ) ,低、中、高浓度(1.0 ,10 .0 ,2 0 .0 μg·L- 1血浆 )方法回收率分别为93.50 % ,10 0 .17% ,98.96 %。天内与天间精密度均小于 13%。结果 :试验片与对照片相比 ,其Tmax分别为 1.2h± 0 .5h和 1.3h± 0 .4h ,Cmax分别为10 μg·L- 1± 3μg·L- 1和 10 .2 μg·L- 1± 2 .5μg·L- 1,AUC0 T 分别为 386 μg·L- 1± 117μg·L- 1和385μg·L- 1± 117μg·h- 1·L- 1,T1/ 2 分别为 36h±14h和 32h± 10h。试验片平均相对生物利用度(10 0± 9) % (n =2 0 ,以AUC0 T计算 )。结论 :试验片与对照片两者生物等效。
Objective: To evaluate the bioequivalence of domestic and imported anastrozole tablets. Methods: Twenty subjects were randomly divided into two groups. One tablet (1mg × 1 tablet) and the reference substance were each administered orally. The blood concentration was determined by gas chromatography. The linear range of the method was 0.5-2.0 μg · L-1 plasma (r = 0.9997, n = 90), low, middle and high concentrations (1.0, 10.0, 2.0 μg · L - 1 plasma) were 93.50%, 100.17% and 98.96%, respectively. The intra-day and inter-day precision are less than 13%. Results: Compared with the control, the Tmax of the test piece was 1.2h ± 0.5h and 1.3h ± 0.4h, respectively, and the Cmax values were 10μg · L- 1 ± 3μg · L- 1 and 10.2μg · L - 1 ± 2.5μg · L-1, AUC0 T were 386 μg · L- 1 ± 117μg · L- 1 and 385μg · L- 1 ± 117μg · h-1 · L- 1 respectively, T1 / 2 was 36h ± 14h and 32h ± 10h. The mean relative bioavailability of the test pieces was (10 0 ± 9)% (n = 20, calculated as AUC0 T). Conclusion: Both the test piece and the photograph are bioequivalent.