硝苯地平缓释片单次给药与多次给药的人体生物等效性研究

Relative Bioavailability of Nifedipine Sustained-release Tablets in Health Volunteers

采用气相色谱 (GC)法测定硝苯地平血浆药物浓度 ,研究硝苯地平缓释片剂的相对生物利用度和生物等效性。 12名健康志愿者随机交叉单次给药口服受试制剂 (T)与参比制剂 (R) 30 m g,18名健康志愿者随机交叉多次给药口服 T与 R30 mg,所测血药浓度及相关药代动力学参数经生物等效性分析 ,在单次给药与多次给药条件下 。

The relative bioavailability of nifedipine sustained release tablets was studied. Twelve healthy volunteers and 18 healthy volunteers were given single or multiple oral dose in a randomized crossover study. The concentration of nifedipine in plasma was determined by gas chromatography (GC). After a single dose (30 mg) and a multiple dose (30 mg), the concentration of plasma nifedipine and the relative pharmacokinetic parameters were obtained. The results of the statistical analysis showed that the two preparations were bioequivalent in absorption extent.