正清风痛宁肠溶片在Beagle犬体内的药动学和生物等效性研究

目的:研究正清风痛宁肠溶片在Beagle犬体内的药动学和生物等效性。方法:选用10只Beagle犬,单剂量随机交叉灌胃正清风痛宁肠溶片受试制剂或参比制剂(10mg·kg-1),用高效液相色谱法测定血药浓度,3p97软件计算药动学参数和生物利用度。结果:受试制剂与参比制剂的药-时曲线呈一室模型,主要药动学参数tmax分别为(86.25±10.61)min和(75.00±16.04)min,Cmax分别为(0.18±0.038)μg·mL-1和(0.18±0.042)μg·mL-1,t1/2Ke分别为(78.34±15.21)min和(88.77±30.90)min,AUC0～T分别为(30.31±7.82)μg·min·mL-1和(32.09±8.61)μg·min·mL-1;受试制剂相对生物利用度为(94.45±5.49)%。结论:受试制剂与参比制剂具有生物等效性。

Pharmacokinetics and Bioequivalence of Zhengqing Fengtongning Enteric Tablets in Beagle Dogs

OBJECTIVE：To investigate the pharmacokinetics and bioequivalence of Zhengqing fengtongning enteric tablets in Beagle dogs.METHODS：In randomized crossover design,10 Beagle dogs were administered with 10 mg·kg -1 of reference tablet or test tablet.Plasma concentration of Zhengqing fengtongning enteric tablets were determined by HPLC.The pharmacokinetic parameters and bioequivalence were calculated using 3p97 software.RESULTS：The concentration-tine curves of reference tablet and test tablet fitted to one-compartment model in Beagle dogs.The main pharmacokinetic parameters of reference tablet vs.test tablet were as follows：T max ：（86.25±10.61）min vs.（75.00±16.04）min;C max ：（0.18±0.038）μg·mL -1 vs.（0.18±0.042）μg·mL -1 ;t 1/2 Ke：（78.34±15.21）min vs.（88.77±30.90）min;AUC 0～T ：（30.31±7.82）μg·min·mL -1 vs.（32.09±8.61）μg·min·mL -1.The relative bioavailability of test tablet was（94.45±5.49）%.CONCLUSION：Results of variance analysis,t-test and non-parameter test shows the two formulations were bioequivalent.