别嘌醇片的生物等效性研究

Study on bioequivalence of allopurinol tablets

目的：评价两种国产别嘌醇片的生物等效性。方法：采用双周期两制剂交叉试验设计法，通过20名健康男性自愿受试者分别单剂量口服300mg片剂A和片剂B，用RP-HPLC测定血清中别嘌醇浓度，计算并比较两药的药动学参数，判定两制剂是否生物等效。结果：测试药和对照药的AUC0～8分别为(8.02±2.08) g·h/ml 和(8.12±2.07)g·h/ml ，Cmax分别为(2.77±0.83) g/ml和(2.73±0.84) g/ml；Tmax 分别为(1.22±0.40)h和(1.27±0.33)h；t1/2分别为(1.79±0.77)h和(1.83±0.99)h相对生物利用度为 98.77%±13.09%。结论：两种别嘌醇片具有生物等效性。

Objective: To evaluate the bioequivalence of two preparations of allopurinol tablets. Methods: Serum concentrations of allopurinol were measured by RP-HPLC. 300mg single oral allopurinol tablets were given to 20 healthy human subjects in an open randomized crossover way to study the pharmacokinetics and bioequivalence. Results: The AUC0～8,cmax, tmax and t1/2 of brands A and B were (8.02±2.08) g·h/ml and (8.12±2.07)g·h/ml, (2.77±0.83) g/ml and (2.73±0.84) g/ml, (1.22±0.40)h and (1.27±0.33)h, (1.79±0.77)h and (1.83±0.99)h, respectively. The mean relative bioavailability of brand A vs brand B was 98.77%±13.09%. Conclusion: The two formulations were bioequivalent.