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8名男性健康受试者交叉口服150mg国产与进口吗氯贝胺片剂,进行国产片的药代动力学和相对生物利用度研究,血药浓度采用高效液相色谱法测定。结果表明:口服国产和进口片剂的血药浓度时间曲线符合血管外给药二室模型,国产片和进口片的主要药代动力学参数Cmax分别为1120±459.19和1127.69±348.57μg·L-1,Tpeak分别为1.646±0.604和1.479±0.525h,T1/2β分别为2.239±0.822和2.223±0.647h,AUC分别为5634.96±2524.20和5253.02±1938.06μg·h·L-1。两种片剂的药代动力学参数经统计学分析无显著性差异(P>0.05)。国产吗氯贝胺片的的相对生物利用度为105.4±23.9%,国产与进口制剂生物等效。
Eight male healthy subjects were taken orally with 150 mg of domestic and imported doxycycline tablets. The pharmacokinetics and relative bioavailability of the domestic tablets were studied. The plasma concentrations were determined by high performance liquid chromatography. The results showed that the time curve of plasma concentrations of oral domestic and imported tablets conformed to the two-compartment model of extravascular administration. The main pharmacokinetic parameters Cmax of domestic tablets and imported tablets were 1120 ± 459.19 and 1127.69 ± 348 .57μg · L-1, Tpeak were 1.646 ± 0.604 and 1.479 ± 0.525h respectively, T1 / 2β were 2.239 ± 0.822 and 2.223 ± 0.647h respectively, AUC were 5634.96 ± 2524.20 and 5253.02 ± 1938.06 μg · h · L-1. Pharmacokinetic parameters of the two tablets showed no significant difference by statistical analysis (P> 0.05). The relative bioavailability of domestic doxycycline tablets was 105.4 ± 23.9%, which was bioequivalent to domestic and imported preparations.