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目的:研究国产盐酸托莫西汀胶囊的人体生物等效性。方法:20名健康男性志愿者按2×2交叉试验方案设计,分别口服受试制剂和参比制剂各20mg,并采集24h内动态血标本;用HPLC-MS-MS法测定血浆中托莫西汀浓度,计算药动学参数,并判定2种制剂的生物等效性。结果:受试制剂和参比制剂的主要药动学参数Cmax分别为(257.1±57.8)μg.L-1和(260.6±51.6)μg.L-1,tmax分别为(1.6±0.9)h和(1.5±1.0)h,t1/2分别为(3.5±1.3)h和(3.3±1.2)h,AUC0-24分别为(939.8±179.2)μg.L-1.h和(983.6±177.3)μg.L-1.h,AUC0-∞分别为(965.2±174.8)μg.L-1.h和(993.8±170.5)μg.L-1.h,2种制剂主要药动学参数经对数转换后进行方差分析及双单侧t检验,并计算90%置信区间,表明2种制剂生物等效,受试制剂的人体生物利用度为(95.6±16.9)%。结论:2种制剂生物等效。
Objective: To study the bioequivalence of domestic atomoxetine hydrochloride capsule. Methods: Twenty healthy male volunteers were enrolled in a 2 × 2 crossover trial. Oral administration of 20 mg of test and reference preparations was given orally and 24 hours of dynamic blood samples were collected. The levels of tamoxocin in plasma were determined by HPLC-MS-MS Ting concentration, pharmacokinetic parameters were calculated and the bioequivalence of the two formulations was determined. Results: The main pharmacokinetic parameters Cmax of test preparation and reference preparation were (257.1 ± 57.8) μg.L-1 and (260.6 ± 51.6) μg.L-1, respectively, with tmax of (1.6 ± 0.9) h and (1.5 ± 1.0) h and t1 / 2 were (3.5 ± 1.3) h and (3.3 ± 1.2) h respectively, and AUC0-24 were (939.8 ± 179.2) μg.L-1.h and (983.6 ± 177.3) μg .L-1.h and AUC0-∞ were (965.2 ± 174.8) μg.L-1.h and (993.8 ± 170.5) μg.L-1.h, respectively. The main pharmacokinetic parameters of two formulations were logarithmically converted After analysis of variance and double unilateral t-test, and calculated 90% confidence interval, indicating that two kinds of preparation bioequivalence, bioavailability of the test preparation was (95.6 ± 16.9)%. Conclusions: Two formulations are bioequivalent.