摘要
目的研究溴吡斯的明片的生物等效性。方法18名健康男性志愿者随机交叉单剂量口服60mg溴吡斯的明受试和参比制剂，考察两种制剂的生物等效性。血浆样本采用Sep-pak C18柱进行固相萃取后，用反相离子对色谱法测定溴吡斯的明的浓度，以计算2种制剂的药动学参数及相对生物利用度，并进行等效性评价。结果2种制剂的各主要药动学参数AUC0～18，Cmax和tmax无显著性差异，受试制剂的相对生物利用度为（102．9±11．6）％。结论双单侧t检验结果表明两制剂具有生物等效性。
Objective To study the relative bioavailability of pyridostigmine bromide tablets. Methods The bioequivalence of pyridostigmine bromid test and reference preparations were investigated with a randomized crossover design at a single oral dose of 60 mg in 18 healthy male volunteers. The drug was extracted from the plasma with Sep-pak Cl8 column by SPE method, and the concentration of pyridostigrnine bromid was determined by reversed phase ion pair chromatography. Results The main parameters AUC0-16, Cmax and tmax of the two preparations had no significant difference. Conclusion The relative bioavailability is （102.9 ±11.6）%. The two one-sided t tests showed that the two preparations are bioequivalent.
出处
《中南药学》
CAS
2009年第4期285-288,共4页
Central South Pharmacy
关键词
反相离子对色谱法
溴吡斯的明
血药浓度
生物利用度
reversed phase ion pair chromatography
pyridostigmine bromid
blood drug level
bioavailability
