论文部分内容阅读
８名青年健康志愿者随机分为两组，间隔两周交叉口服５０ｍｇ国产和进口马普替林片剂，用高效液相色谱荧光检测法测定血浆马普替林浓度，进行相对生物利用度研究。该实验结果表明国产与进口马普替林片剂的体内过程均符合一室动力学模型，Ｔｐｅａｋ分别为９．６±１．４ｈ和１０．４±１．５ｈ，Ｃｍａｘ分别２９．７±１．９μｇ·Ｌ－１和３０．４±２．１μｇ·Ｌ－１，ＡＵＣ分别为２２３２．４±３９７．７μｇ·ｈ·Ｌ－１和２２０５．７±２９６．４μｇ·ｈ·Ｌ－１。统计分析结果表明国产和进口制剂的药代动力学参数均无显著性差异（Ｐ＞０．０５）。以进口制剂为标准，国产马普替林的相对生物利用度为１０１．２％。
Eight young healthy volunteers were randomly divided into two groups. 50mg domestic and imported maprotiline tablets were taken at two-week intervals, and the plasma concentrations of maprotiline were determined by high performance liquid chromatography (HPLC). The relative bioavailability . The experimental results show that domestic and imported maprotiline tablets in vivo process are in line with the one-compartment kinetic model, Tpeak were 9.6 ± 1.4h and 10.4 ± 1.5h, Cmax 29.7 ± 1 .9μg · L-1 and 30.4 ± 2.1μg · L-1 respectively. The AUC were 2232.4 ± 397.7μg · h · L-1 and 2205.7 ± 296.4μg · h · L-1, respectively. Statistical analysis showed no significant difference in pharmacokinetic parameters between domestic and imported preparations (P> 0.05). Based on the imported preparations, the relative bioavailability of domestic maprotiline was 101.2%.