论文部分内容阅读
本文进行了８名健康男性志愿者交叉口服两种舒他西林片剂的生物等效性试验，给药剂量为７５０ｍｇ，建立了ＨＰＬＣ法测定血清中氨苄西林（ＡＭＰ）、舒巴坦（ＳＢＴ）的药物浓度。药物的体内过程经药代动力学程序拟合后，发现符合二室模型，其主要的药代动力学参数如下。Ｃｍａｘ６．５９，８．７５（ＡＭＰ），３．８５，５．７４ｍｇ／ｌ（ＳＢＴ）；Ｔｍａｘ８０．３，５５．１（ＡＭＰ），７５．６，４６．３ｍｉｎ（ＳＢＴ）；Ｔ１／２（β）６３．３，７１．９（ＡＭＰ），５１．６，６２．１ｍｉｎ（ＳＢＴ）；ＡＵＣ１１９２．１，１３４１．９（ＡＭＰ），５６２．３，６０４．２ｍｇ·ｍｉｎ·Ｌ－１（ＳＢＴ）；Ｆ８９．３（ＡＭＰ），９４．２（ＳＢＴ）。统计学检验发现两药在吸收速度方面存在差异（Ｐ＜０．０５）
In this study, eight healthy male volunteers were given oral bioequivalence tests of two sultamiclin tablets at a dose of 750 mg. The method for the determination of ampicillin (AMP), sulbactam (SBT) Drug concentration. The in vivo process of the drug was fitted by a pharmacokinetic program and found to conform to a two-compartment model with the main pharmacokinetic parameters as follows. Cmax 6.59,8.75 (AMP), 3.85,5.74 mg / l (SBT); Tmax 80.3,55.1 (AMP), 75.6,46.3 min (SBT); T1 / 2 β) 63.3, 71.9 (AMP), 51.6, 62.1 min (SBT); AUC1192.1, 1341.9 (AMP), 562.3, 604.2 mg · min · L -1 ); F89.3 (AMP), 94.2 (SBT). Statistical tests found that the two drugs in the absorption rate differences (P <0.05)