国产盐酸曲他维林片的动力学和生物等效性研究

Pharmacokinetics and Bioequivalence of Domestic for Imported Drotaverine Hydrochloric

目的 观察国产盐酸曲他维林片的生物等效性。方法 2 0名健康男性志愿者 ,双周期随机交叉口服单剂量 80mg国产和进口盐酸曲他维林片 ,用高效液相紫外检测法测定血浆中曲他维林的浓度。结果 单剂量口服国产盐酸曲他维林片剂和进口盐酸曲他维林片剂后 ,曲他维林的药时曲线下面积AUC的均值分别为 2 2 4 9.82± 6 2 2 .4 3、2 32 8.6 1± 72 3.0 7h·μg·L-1,峰值浓度Cmax 的均值分别为 4 6 9.39± 10 9.92、4 93.6 3± 16 0 .78μg·L-1。结论 双单侧检验表明 ,国产盐酸曲他维林片和进口盐酸曲他维林片AUC。

Aim To investigate the pharmacokinetics and bioequivalence of domestic for imported drotaverine hydrochloric.Methods Crossover self-controlled study was conducted in 20 health male volunteers. After a single dose of 80mg (40mg×2) drotaverine was given,the plasma drug concentrations were determined by a HPLC method.Restults The pharmacokinetic parameters of domestic for imported drotaverine were AUC 0-24h 2 249.82±622.43 and 2 328.61±723.07h·μg·L -1 ,C max 469.39±109.92 and 493.63±160.78μg·L -1 .Conclusion Both tablets of domestic and imported drotaverine hydrochloric are bioequivalent.