摘要
目的 评价国产和进口雷贝拉唑钠肠溶片在中国人群中的生物等效性。方法 采用高效液相-紫外检测方法测定20名健康受试者po 40mg雷贝拉唑钠肠溶片后血浆中的药物浓度。采用3P97计算药动学参数,并评价其生物等效性。结果 国产雷贝拉唑钠肠溶片和进口肠溶片的tmax分别为(3.23±0.50)和(3.23±0.47)h,cmax为(658±226)和(628±222)μg·L-1,MRT为(3.96±0.52)和(4.28±0.54)h,t1/2为(1.20±0.30)和(1.17±0.26)h,AUC0-10 h为(1 416±457)和(1 414±478)μg·h·L-1。国产雷贝拉唑钠肠溶片的相对生物利用度为(102±17)％。结论 经统计学分析,国产雷贝拉唑钠肠溶片和进口肠溶片具有生物等效性。
OBJECTIVE: To evaluate the bioequivalence of domestic rebeprazole entric tablets and imported tablets. METHODS: A single oral dose of 40 mg domestic or imported sodium rebeprazole entric tablets was given to 20 healthy volunteers in a randomized crossover study. Sodium rebeprazole concentrations in plasma were determined by HPLC method. RESULTS: The main pharmacokinetic parameters of the two products were as follows: tmax were (3.23 ± 0.50) and (3.23 ± 0.47) h, Cmax were (658 ± 226) and (628 ± 222) μg·L-1, MRT were (3.96 ± 0.52) and (4.28 ± 0.-54) h, t12 were (1. 20 ± 0.30) and (1.17 ± 0.26) h, AUC0-10 h were (1 416 ± 457) and (1414 ± 478) μg·h· L-1, respectively. The relative bioavailability of domestic to imported tablets were (102 ± 17)%. CONCLUSION: The results of statistical analysis demonstrated that the two preparations were bioquivalent.
出处
《中国药学杂志》
EI
CAS
CSCD
北大核心
2004年第7期535-537,共3页
Chinese Pharmaceutical Journal
关键词
雷贝拉唑钠
高效液相色谱法
生物利用度
Chemical compounds
Concentration (process)
Pharmacokinetics
Statistical methods
