国产与进口盐酸屈他维林片剂的生物等效性评价

Relative Bioavailability of Domestic and Imported Drotaverine Tablets in Health Volunteers

目的：评价国产曲他维林片剂的生物等效性。方法：20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：数据处理的结果表明，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，AUC的均值分别为2249.82±622.43μg·h·L-1和2328.61±723.07μg·h·L-1, Cmax的均值分别为469.39±109.92μg·L-1和493.63±160.78μg·L-1。结论：双单侧检验表明，国产盐酸曲他维林片剂和进口盐酸曲他维林片剂AUC，Cmax均具有生物等效性。

OBJETIVE: To evaluate the bioequivalence of domestic and imported tablets. METHODS: 20 health volunteers were randomized into A and B groups.A single dose(80mg) of domestic and imported Drotaverine Hydrochloride were given respectively according to an open, two-way crossover design. The plasma concentrations were determined by reverse-phase HPLC with UV-detector , The data were calculated by CRFB program. RESULTS: The results indicated that the AUC0-t of the domestic and the imported tablets were 2249.82±622.43?g·h·L-1 and 2328.61±723.07?g·h·L-1,Cmax were 469.39±109.92?g·L-1 and 493.63±160.78?g·L-1. CONCLUSION: The pharmacokinetic parameters AUC and Cmax were calculated by the two-direction one-sided t test and showed that these two formulations were bioequivalent.