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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。
OBJECTIVE: To evaluate the bioequivalence of domestic triamvelrin tablet. Methods: A total of 20 healthy volunteers were randomized to receive a single dose of 80mg domestic and imported triptorelin hydrochloride tablets. The plasma concentrations of triptorelin were determined by HPLC. Results: The results of data processing showed that the average AUC of single-dose oral domestic triptorelin hydrochloride tablets and imported triptorelin hydrochloride tablets were 2249.82 ± 622.43μg · h · L-1 and 2328.61 ± 723.07μg · H · L-1 and Cmax were 469.39 ± 109.92μg · L-1 and 493.63 ± 160.78μg · L-1, respectively. Conclusion: The double unilateral test showed that both domestic and imported triptorelin hydrochloride triptorelin hydrochloride tablets AUC, Cmax are bioequivalent.