摘要
采用反相高效液相色谱法测定了12例健康志愿者自身交叉随机口服单剂量盐酸氟桂利嗪胶囊30mg和西比灵胶囊30mg后的血浆药物浓度。通过两者的比较,研究盐酸氟桂利嗪胶囊的人体相对生物利用度。结果表明,两胶囊的t_(max),C_(max)经方差分析检验均无显著性差异(P>0.05)。盐酸氟桂利嗪胶囊相对于西比灵胶囊的相对生物利用度为88.5％±15.5％,两胶囊的AUC及C_(max)用双向单侧t检验比较具有生物等效性。
Aim: The plasma concentrations of flunarizine hydrochloride were determined by reversed phase HPLC in 12 healthy subjects after single dose of flunarizine hydrochloride capsule 30 mg or Xibiling capsule 30 mg by oral administration in an open, two-way crossover trial. The relative bioavailability of two flunarizine hydrochloride capsules in human were obtained by making a comparision between the determining results of two preparations. The study results suggested that the difference was not significant between tmax and Cmaxt of two capsules by the analysis of variance. The relative bioavailability of the flunarizine hydrochloride capsule relative to Xililing capsule was 88.5 % ±15.5 %. The relative bioavailability of two capsules were equivalent by the comparision of two one-side t test.
出处
《中国药师》
CAS
2000年第2期67-69,共3页
China Pharmacist
