摘要
目的 :对萘普生钠的两种制剂进行生物等效性评价。方法 :本实验采用高效液相色谱法测定了 18名健康男性志愿受试者随机交叉单剂量口服萘普生钠颗粒剂 (受试制剂 )和胶囊 (参比制剂 )后的不同时刻血浆中萘普生钠的浓度。依据测定数据 ,计算萘普生钠两种制剂的药动学参数及受试制剂的相对生物利用度。结果 :18名健康受试者口服受试制剂和参比制剂后 ,血浆中萘普生钠的Tmax分别为 (1.1± 0 .6 )和 (1.3± 0 .8)h ;Cmax分别为 (36 .1± 7.6 )和 (40 .6± 8.9)mg·L-1;t1/2 分别为(15 .9± 2 .5 )和 (15 .5± 2 .2 )h ;AUC0～t分别为 (499.6± 118.2 )和 (5 39.9± 12 6 .9)mg·h·L-1;AUC0→∞ 分别为 (5 5 9.5± 132 .4 )和 (6 6 7.2± 15 5 .6 )mg·h·L-1。受试制剂的相对生物利用度 (94 .8± 13.1) %。以上参数统计学分析结果表明两种制剂差异无显著性。结论
OBJECTIVE To evaluate the bioequivalence of two dosageforms of naproxen. METHODS Single oral dose of naproxen particles and capsule were given to 18 volunteers in an open randomized crossover way to study the pharmacokinetics and relative bioavailability, naproxen concentrations in plasma were determined by HPLC. RESULTS The pharmacokinetic parameters of test and control formulations were as follows: T max ( 1.1 ± 0.6 ) and ( 1.3 ± 0.8 )h; C max ( 36.1 ± 7.6 ) and ( 40.6 ± 8.9 ) mg·L -1 ; t 1/2 ( 15.9 ± 2.5 ) and ( 15.5 ± 2.2 )h; AUC 0～t ( 499.6 ± 118.2 ) and ( 539.9 ± 126.9 ) mg·h·L -1 ; AUC 0→∞ ( 559.5 ± 132.4 ) and ( 667.2 ± 155.6 ) mg·h·L -1 . The relative bioavailability of test formulation was ( 94.8 ± 13.1 )%. The result of statistical analysis on above parameters showed that there was no significant difference between two formulations. CONCLUSIONS The two formulations were bioequivalent.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2003年第2期67-69,共3页
Chinese Journal of Hospital Pharmacy
