盐酸黄酮哌酯片在健康人体的药代动力学研究

Pharmacokinetics study of flavoxate hydrochloride tablet in healthy volunteers

目的研究盐酸黄酮哌酯片在健康人体的药代动力学。方法20名健康受试者单次口服盐酸黄酮哌酯200 mg,用高效液相色谱(HPLC)法测定血浆中3-甲基黄酮-8-羧酸(3-methylflanone-8-carboxylic acid,MFCA)浓度,用DAS 2.1.1软件计算药代动力学参数。结果血浆中MFCA的主要药代动力学参数如下:Cmax为(8.40±3.33)μg·mL^-1,AUC0-t为(17.59±4.88)μg·mL^-1·h,AUC0-∞为(17.76±4.91)μg·mL^-1·h,Tmax为(1.26±0.45)h,t1/2为(1.86±0.56)h。结论建立的HPLC法灵敏准确,操作简便,适用于MFCA血药浓度检测及盐酸黄酮哌酯药代动力学研究。

Objective To evaluate the pharmacokinetic of flavoxate hydrochloride tablet in healthy volunteers.Methods A single oral dose of 200 mg flavoxate hydrochloride was given to 20 healthy volunteers.The concentration of 3-methylflanone-8-carboxylic acid(MFCA)in human plasma was determined by the validated HPLC method.Main pharmacokinetic parameters were calculated by DAS 2.1.1 software.Results The main pharmacokinetic parameters of MFCA were as follows:Cmax(8.40±3.33)μg·mL^-1,AUC0-t(17.59±4.88)μg·mL^-1·h,AUC0-∞(17.76±4.91)μg·mL^-1·h,Tmax(1.26±0.45)h,t1/2(1.86±0.56)h.Conclusion The established HPLC method is simple and rapid for the determination of MFCA in plasma,which is applicable for the pharmacokinetics study.