论文部分内容阅读
为了建立稳定的吉非罗奇(Gemfibrozil)血药浓度测定方法,了解其胶囊的相对生物利用度。笔者对12名健康男性志愿受试者随机分为2组,每组6人,分别口服单剂量600mg供试品或对照品吉非罗奇胶囊,7d后再交叉服药,采用自建的高效液相色谱法检测血清中药物浓度,实验数据经3P87软件处理,得到药代动力学参数,计算相对生物利用度。结果:口服吉非罗奇胶囊的药代动力学符合一室模型。曲线下面积(0~24h)分别为(104.60±6.20)与(102.90±5.73)μm/ml·h-1;Cmax22.72±1.58与22.33±1.72(μm/ml);消除半衰期分别为(2.28±0.21)与(2.22±0.21)h。供试品胶囊相对生物利用度为101.96±7.76%。结论:供试品与对照品胶囊比较,主要药代动力学参数无明显差异,体内生物作用等效。
In order to establish a stable Gemfibrozil plasma concentration assay, understand the relative bioavailability of its capsules. The author of 12 healthy male volunteers were randomly divided into two groups of 6 people, respectively, a single oral dose of 600mg for the test or reference substance Ge Fei Luo Qi capsule, 7d and then cross medication, with self-built high-performance liquid The concentration of the drug in the serum was detected by the chromatographic method. The experimental data were processed by 3P87 software to get the pharmacokinetic parameters and calculate the relative bioavailability. Results: The pharmacokinetics of gefitinam capsules conformed to the one-compartment model. The area under the curve was (104.60 ± 6.20) and (102.90 ± 5.73) μm / ml · h-1, respectively. Cmax was 22.72 ± 1.58 and 22.33 ± 1 .72 (μm / ml); elimination half-lives were (2.28 ± 0.21) and (2.22 ± 0.21) h, respectively. The relative bioavailability of the test capsule was 101.96 ± 7.76%. Conclusion: There is no significant difference in the main pharmacokinetic parameters between the test and reference capsules, and the biological effect in vivo is equivalent.