头孢羟氨苄泡腾片动物体内生物等效性评价

Relative Bioavailability of the Cefadorxil Effervescent Tablets in Dogs after Administration of Single Oral Dose

取健康雄性杂种狗 8只 ,随机交叉单次灌胃头孢羟氨苄泡腾片 (T)和对照品头孢羟氨苄片 (R) ,分别于服药后取静脉血 ,用高效液相色谱法 (HPL C)测定血浆中头孢羟氨苄浓度。结果求得两种制剂的 Cmax为 (38.2 9±13.6 0 ) μg/ m l和 (40 .80± 15 .0 2 ) μg/ ml;Tmax为 (1.0 0± 0 .6 0 ) h和 (1.38± 0 .6 4 ) h;AUC( 0 - 6 ) 为 (114 .2 2± 39.88)和 (12 5 .31± 4 8.4 4 ) μg/ (ml· h) ;由此求得头孢羟氨苄泡腾片在狗体内相对生物利用度为 (92 .9± 18.1) %。对两种制剂的 AUC( 0 - 6 ) 、Tmax和 Cmax进行统计学分析 。

The relative bioavailability of the cefadorxil effervescent tablets, which were respectively produced by Huazhong (T) and Shijiazhuang (R) Pharmaceutical Companies, was studied in 8 health male hybrid dogs after orally taking a single dose (62 5 mg/kg) according to a randomized crossover design. The blood concentrations of T and R were determined by HPLC. The main parameters were as follows: C max (38 29±13 60) μg/ml and (40 80±15 02) μg/ml; T max (1 00±0 60) h and (1 38±0 64) h; AUC (114 22±39 88) μg/(ml·h) and (125 31±48 44) μg/(ml·h), respectively. The relative bioavailability of T in dogs was (92 9±18 1) %. The statistical analysis showed that both preparations were bioequivalent.