【摘要】 目的评价两种别嘌醇片剂的生物利用度。方法20名健康志愿者,进行随机2周期交叉实验,采用HPLC-UV法测定人血浆中别嘌醇的浓度并计算药动学参数及生物利用度。结果受试剂与参比剂的药?时曲线下面积(AUC0-8)为(5·34±0·74)和(5·64±0·87)μg·h-1·ml-1,峰浓度(Cmax)分别为(2·03±0·42)和(1·99±0·39)μg/ml。达峰时间(Tmax)分别为(1·36±0·58)和(1·64±0·67)h。别嘌醇受试剂的相对生物利用度(F)为(97·9±16·9)%。InAUC0-t、InCmax经方差分析后无显著性差异(P>0·05);AUC0-t、Cmax经双单侧t检验有显著性差异(P<0·05),Tmax经非参数法检验无显著性差异(P>0·05)。结论两制剂具有生物等效性。更多还原

【Abstract】 Objective To evaluate the bioequivalence of two preparations of allopurinol tablets.Methods Serum concentrations of allopurinol were measured by HPLC. 300mg single oral allopurinol tablets were given to 20 healthy male volunteers in a randomized crossover way to study the pharmacokinetics and bioequivalence. Results Following a single dose of allopurinol administration of two preparations, the mean AUC_ 0～inf values of the test and reference tablets were (5.34±0.74) and (5.64±0.87)μg·h~ -1 ·ml~ -1 , C_ max (2.03±0.42) and (1.99±0.39)μg/ml,and T_ max (1.36±0.58) and (1.64±0.67)h, respectively. The relative bioavailability (F) of allopurinol was 97.9%±16.9%. Through the analysis variance of InAUC and InC_ max showed no significant difference(P>0.05), the result of two-side “t” test and 90% confidential interval test was significantly different (P<0.05) between the two preparations. Conclusion The two preparations are bioequivalent.更多还原