摘要
目的:在中国健康成年男性志愿者中比较研究国产和进口加替沙星片剂的药代动力学参数,评估两者的生物等效性。方法:24名健康男性志愿者随机自身前后交叉给药,分别单剂口服国产和进口加替沙星片400mg。以HPLC测定血药浓度,应用DAS软件计算两者的药代动力学并考察其生物等效性。结果:受试者分别应用国产片剂(试验制剂)和进口片剂(参比制剂)400mg后,两药药-时曲线均符合二房室模型,主要药代动力学参数:Tmax分别为(0.99±0.41)h和(1.11±0.60)h;Cmax分别为(4.11±0.76)μg/mL和(3.89±0.54)μg/mL;t1/2β分别为(7.75±0.81)h和(7.39±0.92)h;AUC0-36h分别为(29.81±5.70)μg·mL-1·h和(30.77±4.40)μg·mL-1·h;AUC0-∞分别为(30.97±6.01)μg·mL-1·h和(31.85±4.58)μg·mL-1·h;国产片剂对于进口片剂的相对生物利用度F0-36h为(97.63±19.15)%。结论:国产与进口加替沙星片剂为生物等效制剂。
Objective：To study pharmacokinetics and bioequivalence of domestic and imported Gatifloxacin tablets in Chinese healthy volunteers.Methods：A single oral dose 400mg of domestic and imported Gatifloxacin tablets were given to 24 healthy volunteers in a randomized cross-over study.The concentrations of Gatifloxacin in human plasma were determined by HPLC and the pharmacokinetic parameters were calculated by DAS software.Results：The concentration-time curve of Gatifloxacin in plasma fit two compartment model after an oral single dose 400mg. The main pharmacokinetic parameters of domestic and imported tablet were as follows： Tmax were （0.99±0.41）h and （1.11 ±0.60）h, Cmax were （4.11±0.76）μg/mL and （3.89±0.54）μg/mL, t（1/2β） were （2.16±0.62）h and （2.31±0.50）h, AUC（0-36） were （29.81±5.70）μg·mL^-1·h and （30.77±4.40）μg·mL^-1·h, AUC（0-∞） were （30.97±6.01）μg·mL^-1·h and （31.85± 4.58）μg·mL^-1·h respectively.The relative bioavailability of Gatifloxacin was （97.63±19.15）%.Conclusion：The domestic and imported Gatifloxacin tablets were bioequivalent.
出处
《中国药物应用与监测》
CAS
2007年第4期18-21,共4页
Chinese Journal of Drug Application and Monitoring
