奈韦拉平片的血药浓度测定及相对生物利用度

Determination of nevirapine in human plasma by HPLC and study on its bioequivalence

目的建立奈韦拉平血药浓度的HPLC测定法,用于人体生物等效性研究。方法采用随机双交叉试验设计,20名健康受试者口服受试制剂和参比制剂200mg,用HPLC法测定血浆中的奈韦拉平浓度。结果受试制剂和参比制剂的AUC_(0→t)分别为(155.66±22.41)、(150.66±22.11)mg·h·L^(-1);AUC_(0→∞)分别为(163.30±22.88)、(157.75±22.87)mg·h·L^(-1);c_(max)分别为(2.52±0.31)、(2.60±0.48)mg·L^(-1);t_(max)分别为(3.1±0.7)、(3.0±0.7)h;T1/2分别为(38.12±2.23)、(36.79±5.06)h。受试制剂的相对生物利用度为(103.6±8.6)%。经统计学分析,2种制剂的AUC_(0→∞),c_(max),t_(max),T1/2差异无显著性意义(P>0.05)。结论国产奈韦拉平片与进口奈韦拉平片具有生物等效性。

A/M To establish a method to study the pharmacokinetics and relative bioavailability of nevirapine tablets in Chinese healthy volunteers. METHODS Twenty healthy male volunteers received 200 rng nevirapine tablets orally in a random crossover design. Drug concentrations in plasma were determined by HPLC. RESULTS The main pharmacokinetie parameters of tested tablet and reference tablet were as follows： AUC0→t ： （ 155.66 ± 22.41 ） vs （ 150.66 ± 22.11）mg·h·L^-1,AUC0→∞：（163.30±22.88） vs （157.75 ±22.87） mg·h·L^-1,cmax：（2.52±0.31） vs （2.60± 0.48） mg·L^-1, tmax ： （3.1 ± 0.7） VS （3.0 ± 0.7） h, T1/2（38.12 ± 2.23） vs （36.79 ± 5.06）h, respectively. The relative bioavailability of the tested tablet was （ 103.6 ± 8.6） %. CONCLUSION The results demonstrates that the tested tablet and reference tablet are bioequivalent.