齐多夫定胶囊在健康人体的药代动力学及生物等效性

Pharmacokinetics and bioequivalence of zidovudine capsule in healthy volunteers

目的评价国产和进口齐多夫定胶囊在健康人体的生物等效性。方法 20名健康受试者口服齐多夫定胶囊300 mg,用高效液相色谱法测定血浆中齐 多夫定的浓度。结果 国产和进口齐多夫定胶囊的达峰时间tmax分别为(0．66 ±0．20)和(0．64±0．24)h;达峰浓度Cmax为(1990．15±737．48)和(2014．14± 691．80)ng·mL-1;AUC0-7分别为(2166．02±569．31)和(2218．53±696．20)ng ·h·mL-1;AUC0-∞分别为(2218．51±575．51)和(2272．68±695．26)ng·h· mL-1;t1/2分别为(1．58+0．46)和(1．57+0．43)h。国产齐多夫定胶囊相对生 物利用度为(99．74±20．82)％。结论国产与进口齐多夫定胶囊具有生物等 效性。

Objective To observe the bioequivalence of domestic and imported zidovudine capsule . Methods A single oral dose of 300 mg domestic or imported zidovudine capsule was given to 20 healthy volunteers in a randomized cross -over study. Zidovudine concentrations in plasma were determined by HPLC methods, Results The main pharmacokinetic parameters of the two products were as follow ： tmax were （ 0. 66 ±0. 20 ） 和（ 0. 64 ± 0. 24） h, Cmax were （ 1990. 15± 737.48 ） 和 （ 2014. 14± 691.80 ） ng·mL^-1, AUC0-7 were（2166. 02 ±569.31）和（2218.53±696. 20）ng·h·mL^- 1, AUC0-∞ were （2218.51± 575.51 ） 和 （ 2272.68 ± 695.26 ） ng· h· mL^-1,t1/2 were （1.58 ±0.46）和（1.57±0.43） h, respectively. The relative bioavailability of domestic to imported capsule was （99.74±20. 82）%. Corlclusion There was no significant difference between the parameters of the two groups （ P 〉 0.05 ）. The results demonstrated that the two preparations were bioequivalent.