论文部分内容阅读
12名健康受试者随机交叉给药，分别口服单剂量国产马来酸伊索拉啶片剂及进口片剂8mg进行生物等效性的研究。采用高效液相紫外检测法测定血浆中马来酸伊索拉啶的浓度，经3p97中生物等效性程序计算处理，被试制剂和标准参比制剂的：Tpeak分别为8.67±2.15h和9.00±2.23h，Cmax分别为300.09±20.21μg·L-1和302.48±21.91μg·L-1，T1/2ke分别为127.18±16．83h和126．24±19．88h，经配对t检验，两者的AUC0-t，Teak,Cmax,T1/2Ke等主要药代动力学参数均无显著性差异（P＞0.05）。采用梯形法计算的两者的AUC0-t产值分别为37500.59±7605.32μg·h·L－1和38518．18±6934.74μ·h·L－1，经统计学分析，被试制剂和标准参比制剂具有生物等效性。被试制剂的相对生物利用度为97．3±5．9％。
Twelve healthy subjects were randomized to receive oral administration of a single dose of domestic iso-tomazole tablet and 8 mg of the imported tablet for bioequivalence studies. Plasma isozolidine concentration was determined by HPLC method. The bioequivalence was calculated by 3p97 bioequivalence test. The Tpeaks of the test preparations and standard reference preparations were 8.67 ± 2.15h and 9.00 ± 2.23h and Cmax were 300.09 ± 20.21μg · L-1 and 302.48 ± 21.91μg · L-1 respectively, T1 / 2ke were 127.18 ± 16.83h and 126.24 ± 19.88h, respectively. According to the paired t test, The main pharmacokinetic parameters such as AUC0-t, Teak, Cmax, T1 / 2Ke had no significant difference (P> 0.05). The AUC0-t output values calculated by trapezoidal method were 37500.59 ± 7605.32μg · h · L-1 and 38518.18 ± 6934.74μ · h · L-1, respectively. According to the statistical analysis, The formulation is bioequivalent. The relative bioavailability of the test preparation was 97.3 ± 5.9%.