注射用羟丙基β-环糊精-新鱼腥草素钠冻干粉针Beagle犬体内的药代动力学

Pharmacokinetics of hydroxyl-β-dextrin 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,测定注射用羟丙基β-环糊精-新鱼腥草素钠冻干粉针剂Bea-gle犬体内的药代动力学参数。方法:高效液相色谱法测定3种剂量新鱼腥草素钠给药后不同时间的血浆含量,DAS新药开发统计软件计算统计药代动力学参数。结果:3个剂量间各种主要药代动力参数均无显著性差异。结论:静脉给药剂量对新鱼腥草素钠的体内分布速率无明显影响。

AIM： To establish the method of determining sodium new houttuyfonate in plasma and study its pharmacokinetics in beagle dogs. METHODS：The HPLC was employed with chromatographic conditions, such as octa,silicane bond silica gel column （250 mm × 4.6 mm, 5 μm） as analyti hydroxide with 4 butyls（70：30：0. 3） as mobile phase and at the flow-rate cal column, methanol-water-ammonium of 1.0 mL/min. The UV detection was set at 286 nm. The pharmacokinetic parameters were calculated by DAS（ ver 1.0） 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. 999 2 ） , good precision and high recoveries. The parameters were Tmax = 5.0 min, Cmax = 4. 982 mg/L, T1/2 = 8.67 min. 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.