萘普生钠片的人体生物等效性

Bioequivalence of naproxen sodium tablets in healthy volunteers

目的 :比较国产和进口萘普生钠片在 2 0名男性健康受试者间的药物动力学和生物等效性。方法 :随机交叉单剂量口服萘普生钠片 0 .5 5 g后 ,采用高效液相色谱 -荧光检测法测定血药浓度。结果 :国产和进口萘普生钠片的药物动力学参数如下 :AUC0 - t分别为 (975 .36± 176 .5 1)、(982 .5 5± 141.0 4) ︼g· h/ ml;cmax分别为 (72 .0 5± 13.95 )、(75 .6 2± 15 .0 5 ) ︼g/ m l;tmax分别为 (1.6 0± 1.17)、(1.15± 0 .5 9) h;T1 / 2 分别为 (11.6 9± 1.47)、(11.82± 1.38) h。经统计学处理 ,上述各项参数间差别均无统计学意义 (P>0 .0 5 )。国产萘普生钠片相对生物利用度为 (99.18± 9.93) %。结论

AIM: To compare pharmacokinetics and bioavailability of naproxen sodium tablets with imported in 20 healthy male volunteers. METHODS: A signle oral dose (0 55 g) was given according to a randomized two cross over design, the plasma concentrations of naproxen sodium were measured by high performance liquid chromatography method with fluorescence detection (320/359 nm). RESULTS: The main paramacokinetic parameters of domestic and imported tablets were as follows: AUC 0 t (975 36±176 51) and (982 55±141 04) μg·h/ml; c max (72 05±13 95) and (75 62±15 05) μg/ml; t max (1 60±1 17) and (1 15±0 59) h; T 1/2 (11 69±1 47) and (11 82±1 38) h, respectively. The result of statistical analysis showed that there was no significant difference of the AUC 0 t , c max and t max between domestic and imported tablets. CONCLUSION: The relative bioavailability of the domestic tablets is (99 18±9 93)%. The results of two one side test and (1 2α) confidence intervals test show that the tablets are bioequivalent.