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目的评价卵磷脂络合碘片的药物动力学特征。方法用催化光度法测定血药质量浓度;采用双周期交叉试验设计,18名受试者单剂量口服4.5 mg受试制剂与参比制剂,用Das 2.0软件计算两者的药物动力学参数。结果受试制剂与参比制剂中卵磷脂络合碘的主要药物动力学参数tm ax、mρax、t1/2、AUC0-48、AUC0-∞分别为(1.3±0.4)、(1.2±0.3)h,(34.5±9.5)、(34.6±12.7)μg.L-1,(5.8±3.2)、(5.7±3.8)h,(176.7±34.9)、(171.9±49.4)μg.h.L-1,(188.2±37.6)、(194.4±60.2)μg.h.L-1;主要药物动力学参数无显著性差异;受试制剂的相对生物利用度(F)为(107.4±23.3)%。结论受试制剂与参比制剂具有生物等效性。
Objective To evaluate the pharmacokinetics of lecithin complex iodine tablets. Methods The concentration of plasma drug was determined by catalytic spectrophotometry. The double-cycle crossover design was used. Eighteen subjects were given single oral dose of 4.5 mg of test preparation and reference preparation, and the pharmacokinetic parameters were calculated by Das 2.0 software. Results The main pharmacokinetic parameters tm ax, mρax, t 1/2, AUC0-48 and AUC0-∞ of lecithin-complexed iodine in test and reference preparations were (1.3 ± 0.4), (1.2 ± 0.3) h (34.5 ± 9.5), (34.6 ± 12.7) μg.L-1, (5.8 ± 3.2), (5.7 ± 3.8) h, (176.7 ± 34.9), (171.9 ± 49.4) μg.hL- ± 37.6), (194.4 ± 60.2) μg.hL-1 respectively. There was no significant difference in the main pharmacokinetic parameters between two groups. The relative bioavailability (F) of the test preparation was (107.4 ± 23.3)%. Conclusion The test preparation and the reference preparation are bioequivalent.