卵磷脂络合碘片的人体生物等效性考察

Bioequivalence of iodized lecithin tablets in healthy human volunteers

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 study the relative bioavailability and bioequivalence of two kinds of iodized lecithin tablets in healthy human volunteers. Methods A random crossover trial was performed in 18 healthy volunteers. In either of the two study periods, a single oral 4.5 mg dose of two kinds of iodized lecithin tablets was administered to each volunteer. Serum concentrations of iodized lecithin were determined by catalytic spectrophotometry method. The pharmacokinetic parameters as well as the relative bioavailability were measured by Das 2.0 software. Results The phannacokinetic parameters of the test tablets and reference tablets were as following：tmax were（1.3 ±0.4）and（1.2 ±0.3）h;pmax were（34. 5 ±9. 5）and（34.6 ± 12.7）μg·L^-1;q/2 were（5.8 ± 3.2） and （5.7± 3. 8） h; AUC0→48 were（ 176.7 ± 34.9） and（ 171.9 ± 49.4）μg·L^-1; AUC0→∞, were （ 188.2 ± 37.6 ） and （ 194.4 ±60.2）μg·L^-1. There were no significant differences in main pharmacokinetic parameters. The iodized lecithin tablets bioavailability of the test tablets was （107.4 ± 23.3 ）% in comparison with the reference tablets. Conclusions The test tablets and the reference tablets are bioequivalent.