两种注射用新鱼腥草素钠Beagle犬药代动力学研究

The investigate of pharmacokinetics of two sodium new houttuyfonate injection in Beagle dogs

目的:建立犬血浆中新鱼腥草素钠浓度测定的方法学,比较羟丙基β-环糊精-新鱼腥草素钠冻干粉针剂对新鱼腥草素钠Beagle犬体内的药代动力学参数影响。方法:高效液相色谱法测定两种注射用新鱼腥草素钠三个不同剂量新鱼腥草素钠给药后不同时间的血浆含量,DAS新药开发统计件计算统计药代动力学参数,结果:羟丙基β-环糊精-新鱼腥草素钠冻干粉针剂与市售注射用新鱼腥草素钠主要药代动力参数均无显著性差异。结论:羟丙基β-环糊精-新鱼腥草素钠冻干粉针剂和给药剂量对新鱼腥草素钠静脉给药的体内分布速率无明显影响。

Objective： To establish the determining method of sodium new houttuyfonate in plasma and study the pharmacokinetics of sodium new houttuyfonate in beagle dogs. Methods： The HPLC was employed. The chromatographic conditions used in this study were of octa - silicane bond silica gel column （ 250mm × 4.6mm,5 μm） as analytical column, methanol - water - ammonium hydroxide with 4 butyls （ 70 ： 30：0.3 ） as mobile phase and at the flow - rate of 1.0ml/min. The UV detection was set at 286nm. The pharmacokinetic parameters were calculated by DAS（ ver1. 0） program and compared by statistic analysis. Results： The calibration curve was linear in blood plasma over the concentration range of 0. 128 - 25. 575 mg/L （ r = 0. 9992） , well precision and high recoveries. The parameters were Tmax = 5.0min, Cmax = 4.982mg/L, T1/2 = 8.67min. Conclusion： the analytical method established in this study is sensitive and exact, and can be used to measure the pharmacokinetics of sodium new houttuyfonate in beagle dog. The sodium new houttuyfonate can metabolize quickly following intravenous injection.