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目的 :建立血浆中阿替洛尔的固相萃取结合HPLC的检测方法 ;对两厂家生产的阿替洛尔片在人体内的相对生物利用度及生物等效性进行评价。方法 :血样采用固相萃取法处理 ,HPLC 荧光检测法测定 ,外标法定量。生物等效性以AUC0～ 36 、Cmax、Tmax为指标 ,双单侧t检验作判断。结果 :实验制剂与参比制剂的药动学参数AUC0～ 36 、Cmax、Tmax、t1/2 分别为 5 15 0 .3 5± 1172 .5 2、5 4 66.5 0± 12 77.0 8ng·h·ml 1;717.0 4± 189.69、678.63± 193 .3 6ng·ml 1;2 .4 2± 0 .4 5、2 .63± 0 .5 4h ;7.84± 1.2 5、7.73± 1.5 9h。配对t检验结果 ,两厂家产品的AUC0～ 36 、Cmax、Tmax均无显著性差异 (P >0 .0 5 )。结论 :固相萃取结合HPLC法为一种测定血浆阿替洛尔浓度较为理想的方法。两厂家产阿替洛尔片为生物等效制剂 ,试验药物对参比药物相对生物利用度为 94 .2 2 %。
OBJECTIVE: To develop a HPLC method for the determination of atenolol in plasma and to evaluate the relative bioavailability and bioequivalence of atenolol tablets produced by the two manufacturers in human. Methods: Blood samples were processed by solid-phase extraction, HPLC fluorescence detection method, external standard method. Bioequivalence AUC0 ~ 36, Cmax, Tmax as an index, double unilateral t test for judgment. Results: The pharmacokinetic parameters AUC0 ~ 36, Cmax, Tmax, t1 / 2 of the experimental and reference preparations were respectively 5 15 0 .3 5 ± 1172 .5 2,5 4 66.5 0 ± 12 77.0 8ng · h · ml 1; 717.0 4 ± 189.69, 678.63 ± 193.36ng · ml 1; 2.42 ± 0.45, 2.63 ± 0.54h; 7.84 ± 1.2 5,7.73 ± 1.59h. Paired t test results, two manufacturers of products AUC0 ~ 36, Cmax, Tmax no significant difference (P> 0.05). Conclusion: Solid-phase extraction combined with HPLC method is a more ideal method for the determination of plasma atenolol concentration. Two factories producing atenolol tablets for bioequivalent formulations, the relative bioavailability of test drugs to reference drugs was 94.22%.