重组人生长激素在猕猴体内相对生物利用度研究

Study on Relative Bioavailability of rhGH in Macaque Bodies

目的评价重组人生长激素(rhGH)冻干粉针剂受试制剂与参比制剂在猕猴体内的相对生物利用度。方法猕猴随机分成两组,运用交叉设计方法,先后接受皮下注射受试制剂或参比制剂0.5IU·kg-1,测定不同时间点生长激素血药浓度,并进行相关药动学参数分析。结果受试制剂与参比制剂的主要药代动力学参数Tmax分别为(3.0±1.4)、(2.3±1.8)h;Cmax分别为(173.2±79.0)、(159.0±41.3)μg·L-1;AUC(0-12h)分别为(1139±258)、(1108±390)μg·h·L-1;结论受试制剂的相对生物利用度为(107±16)%。

Aim To investigate the relative bioavailability of tested and reference rhGH in Macaque Bodies. Methods A randomized,self-control and crossover design was adopted. 4 male macaques were administered with rhGH by subcutaneous injection at a single dose of 0. 5IU·kg^- 1. The venous blood samples were collected at different points to test the serum concentrations of GH. The main pharmacokinetic parameters and bioequivalence of the two formulations were evaluated. Results The main pharmacokinetic parameters of tested and reference drugs were as follows： Tmax （3.0± 1.4）h vs （2.3 ±1.8）h, C max（173.2 ±79. 0） μg·L^-1vs （159.0 ±41.3） μg·L^-, AUC（0-12h） （1 139 ±258） μg·h·L^-1 vs （1 108 _＋ 390） μg·h·L^-1. Conclusion The relative bioavailability of the tested rhGH was （107 ± 16）%.