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目的研究2种盐酸舍曲林制剂的人体生物等效性。方法采用双周期随机交叉设计试验,22名健康男性志愿者单剂量口服盐酸舍曲林口服液(受试制剂)或盐酸舍曲林片(参比制剂)50mg,以高效液相色谱-质谱联用法测定血药浓度。结果受试制剂与参比制剂的t1/2分别为(27.3±5.2)、(26.3±3.0)h,Cmax分别为(9.56±2.49)、(9.43±2.91)μg·L-1,tmax分别为(5.18±1.47)、(6.00±1.07)h,AUC0～108分别为(329±112)、(297±111)μg.h·L-1,AUC0～∞分别为(354±127)、(316±122)μg.h.L-1。经方差分析和双单侧t检验,主要药动学参数无差异,但tmax存在差异;受试制剂的相对生物利用度为(115.5±26.7)%。结论2种盐酸舍曲林制剂具有生物等效性。
Objective To study the bioequivalence of two sertraline hydrochloride preparations. Methods A double-cycle randomized crossover design test was conducted. Twenty-two healthy male volunteers were given a single oral dose of sertraline hydrochloride (test preparation) or sertraline hydrochloride (reference preparation) 50 mg, and were analyzed by high performance liquid chromatography-mass spectrometry Usage Determination of blood concentration. Results The t1 / 2 of the test preparation and the reference preparation were (27.3 ± 5.2) and (26.3 ± 3.0) h, respectively, and the Cmax values were 9.56 ± 2.49 and 9.43 ± 2.91 μg · L-1, respectively AUC0 ~ 108 were (329 ± 112) and (297 ± 111) μg.h · L-1, respectively, and AUC0 ~ ∞ were (354 ± 127) and ± 122) μg.hL-1. By means of ANOVA and double unilateral t-test, there was no difference in the main pharmacokinetic parameters, but there was a difference in tmax; the relative bioavailability of the test preparation was (115.5 ± 26.7)%. Conclusion The two kinds of sertraline hydrochloride preparations are bioequivalent.