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目的:研究卵磷脂络合碘胶囊在家犬体内的药动学和生物利用度。方法:4只犬随机分成2组进行2周期交叉自身对照实验,分别单剂量口服200μg受试制剂卵磷脂络合碘胶囊及参比制剂卵磷脂络合碘片,给药后不同时间采血样,用气相色谱法测定犬血浆中的药物浓度并计算药动学参数。结果:受试及参比制剂的t1/2(ke)分别为(7.7±2.44)、(6.85±2.85)h;tmax分别为(0.83±1.01)、(1.17±0.76)h;Cmax分别为(7.96±3.10)、(8.74±0.37)μg.dL-1;AUC0-∞分别为(89.94±41.98)、(91.03±32.62)μg.h.dL-1(P>0.05),受试制剂的相对生物利用度为117.4%。结论:2种卵磷脂络合碘制剂具有生物等效性。
Objective: To study the pharmacokinetics and bioavailability of lecithin complex iodine capsules in dogs. Methods: Four dogs were randomly divided into 2 groups to carry out 2-cycle self-controlled crossover study. A single dose of 200 μg lecithin iodine capsules and reference preparation lecithin iodine tablets were orally administered at a single dose. Blood samples were taken at different times after administration. Gas chromatographic determination of drug concentration in the plasma of dogs and calculation of pharmacokinetic parameters. Results: The t1 / 2 (ke) of the tested and reference preparations were (7.7 ± 2.44) and (6.85 ± 2.85) h, respectively, and the tmax values were (0.83 ± 1.01) and (1.17 ± 0.76) 7.96 ± 3.10) and (8.74 ± 0.37) μg.dL-1, respectively; AUC0-∞ were (89.94 ± 41.98) and (91.03 ± 32.62) μg.h.dL-1 Bioavailability was 117.4%. Conclusion: Two kinds of lecithin complex iodine formulations are bioequivalent.