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目的考察佐匹克隆片受试制剂和参比制剂的人体相对生物利用度,评价两种制剂生物等效性。方法采用两制剂双周期交叉试验方法,20例男性健康受试者分别口服佐匹克隆片受试制剂或参比制剂15 mg,高效液相色谱荧光检测法检测血浆佐匹克隆浓度,DAS2.1药动学软件分析,并作生物等效性评价。结果受试制剂与参比制剂t1/2分别为(4.93±2.45)和(5.46±2.51)h;Cmax分别为(101.18±23.47)和(105.39±35.21)ng.mL-1;tmax分别为(1.60±1.16)和(1.64±1.35)h;AUC0-24分别为(612.66±157.35)和(617.27±207.11)ng.h.mL-1;AUC0-∞分别为(664.88±160.27)和(679.12±223.75)ng.h.mL-1。根据AUC0-t计算,受试制剂的相对生物利用度F0-t为(105.1±28.9)%。结论两种佐匹克隆片生物等效。
OBJECTIVE To investigate the relative bioavailability of zopiclone tablets and reference preparations in humans and to evaluate the bioequivalence of the two preparations. Methods Two-cycle crossover test was used. Twenty male healthy volunteers were treated with either zopiclone or 15 mg of reference preparation respectively. The concentration of zopiclone in plasma was detected by high performance liquid chromatography (HPLC) Pharmacokinetic software analysis, and bioequivalence assessment. Results The t1 / 2 of test preparation and reference preparation were (4.93 ± 2.45) and (5.46 ± 2.51) h respectively; the Cmax were (101.18 ± 23.47) and (105.39 ± 35.21) ng.mL- 1.60 ± 1.16 and 1.64 ± 1.35 h, AUC0-24 were (612.66 ± 157.35) and (617.27 ± 207.11) ng.h.mL-1, respectively; AUC0-∞ were (664.88 ± 160.27) and 223.75) ng.h.mL-1. The relative bioavailability F0-t of the test formulations was (105.1 ± 28.9)% based on AUC0-t. Conclusions Both zopiclone tablets are bioequivalent.