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目的：在健康志愿者中进行国产与进口盐酸丁螺环酮片剂药代动力学及生物利用度的比较研究。方法：受试者随机分成２组，交叉口服国产与进口盐酸丁螺环酮片各１５ｍｇ，采用气－质联用选择离子色谱（ＧＣ－ＭＳ／ＳＩＭ）法测定血浆中药物浓度。结果：口服２种片剂的药－时曲线均符合二室模型，国产与进口片Ｔ１／２β分别为４．２５６±１．７９０与５．９９０±２．１０１ｈ；Ｔｍａｘ分别为０．８７９±０．６１０与０．５５９±０．２６３ｈ；Ｃｍａｘ分别为６．０００±２．８８１与８．８７１±４．５１６μｇ·Ｌ－１；ＡＵＣ分别为２５．７５６±４．７００与２４．５３２±２．８２７μｇ·ｈ·Ｌ－１。国产盐酸丁螺环酮片剂对进口盐酸丁螺环酮片剂的相对生物利用度为１０４．６９％。结论：２种片剂的各项动力学参数经统计学分析无显著性差异（Ｐ＞０．０５），国产盐酸丁螺环酮片剂在人体内的生物利用度与进口片剂相当
OBJECTIVE: To compare the pharmacokinetics and bioavailability of domestic and imported buspirone hydrochloride tablets in healthy volunteers. Methods: The subjects were randomly divided into two groups. The domestic and imported buspirone hydrochloride tablets were taken as 15mg crossover and the plasma drug concentration was determined by gas chromatography-mass spectrometry with selective ion chromatography (GC-MS / SIM). Results: The drug-time curves of the two tablets were in accordance with the two-compartment model. The T1 / 2β of domestic and imported tablets were 4.256 ± 1.790 and 5.990 ± 2.101 h, respectively. The Tmax were 0.879 ± 0.610 and 0.559 ± 0.263h; Cmax were 6.000 ± 2.881 and 8.871 ± 4.516μg · L-1, respectively; AUC were 25.756 ± 4.700 and 24.532 ± 2.827 μg · h · L-1. The relative bioavailability of domestic buspirone tablets to imported buspirone hydrochloride tablets was 104.69%. Conclusion: The kinetic parameters of the two tablets showed no statistical difference (P> 0.05). The domestic bioavailability of domestic buspirone tablets was comparable to imported tablets