灯盏花素缓释片在Beagle犬体内相对生物利用度的研究

The relative bioavailability of Breviscapine sustained-release tablets in Beagle dogs

目的 探讨灯盏花素缓释片在动物体内的药物动力学规律 ,并进行相对生物利用度研究。方法 采用双周期交叉试验设计 ,对Beagle犬单剂量顿服灯盏花素缓释片和参比制剂的动力学参数进行比较。结果 采用尿药法进行数据处理 ,参比制剂与供试制剂的尿药总排泄量 (Xu)分别为 375 92 5± 4 7 2 3μg和 394 5 92± 32 84 μg ;生物半衰期 (t1/2 )分别为 7 197± 0 5 91h和 12 6 2± 1 2 0 7h。结论 以吸收总量为指标 ,灯盏花素缓释片与参比制剂相比是生物等效制剂 ,并具有缓释特征。

OBJECTIVE To investigate the pharmacokinetics and the relative bioavailability of Breviscapine Sustained-release tablets in animals.METHODS The cross-over design(two periods)was employed.The pharmacokinetics parameters were compared after Beagle dogs were administrated a single dose of the oral Breviscapine Sustained-release tablets and the reference preparation.RESULTS The experimental data were caculated by uring-drug methods.Xu of the reference and the test preparations were 375.925±47.23 μg and 394.592±32.84 μg respechvely.The t 1/2 were 7.197±0.591 h and 12.62±1.207 h,respectively.CONCLUSION Compared with the reference preparation,Breviscapine Sustained-release tablets have the characteristic of sustained-release and are bioequivalent when the tolal absorptivity is taken as the index.