【摘要】 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。更多还原

【Abstract】 AIM: To evaluate the bioequivalence of domestic and imported anastrozole tablet. METHODS: According to the crossover design, each volunteer was orally given anastrozole tablets (1 mg). GC determined the drug concertrations in plasma. The linear ranges was from 0.5 to 200.0 μg·L -1 plasma ( r =0.9997, n =9). The recovery rates of lower, mid, higher concentration (1.0,10.0,20.0 μg·L -1 plasma were 93.50 %, 100.17 %,98.96 % respectively. Inter day and intra day precisions of the method were <13 %. RESULTS: The pharmacokinetic parameters of the domestic and imported tablet were 1.2 h±0.5 h and 1.3 h±0.4 h for T max , 10 μg·L -1 ±3 μg·L -1 and 10.2 μg·L -1 ± 2.5 μg·L -1 for C max , 386 μg·L -1 ±117 μg·L -1 and 385 μg·L -1 ±117 μg·h -1 ·L -1 for AUC 0-T ,36 h±14 h and 32 h±10 h for T 1/2 respectively. The relative bioavailability of the domestic tablet was (100±9) %. CONCLUSION: Domestic and imported anastrozole tablet are bioequivalence in healthy volunteers.更多还原