国产与进口齐多夫定胶囊在健康人体的药代动力学和生物等效性  

Pharmacokinetics and bioequivalence of domestic and imported zidovudine capsules in healthy volunteers

作　　者：李小利[1] 王本杰[1] 倪梅媛[1] 郭瑞臣[1] 

机构地区：[1]山东大学齐鲁医院临床药理研究所,济南250012

出　　处：《中国临床药理学杂志》2007年第4期288-291,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的研究国产与进口齐多夫定胶囊(抗艾滋病药)在健康志愿者体内的药代动力学和生物等效性。方法20名健康男性受试者随机交叉单剂量口服国产与进口齐多夫定胶囊300mg,用高效液相色谱法测定给药后不同时间的血浆浓度,计算主要药代动力学参数。结果国产与进口齐多夫定胶囊主要药代动力学参数:t1/2分别为(1.72±0.42),(1.53±0.27)h;tmax分别为(0.86±0.42),(0.88±0.30)h;Cmax分别为(1.60±0.61),(1.60±0.55)μg.mL-1;AUC0～8分别为(2.06±0.37),(2.08±0.34)μg.h.mL-1;AUC0-∞分别为(2.11±0.37),(2.12±0.34)μg.h.mL-1。国产齐多夫定胶囊相对生物利用度F为(99.02±5.02)%。结论2制剂具有生物等效性。Objective To study the pharmacokinetics and bioequivalenee after single oral administration of domestic （test） and imported （reference） zidovudine capsules in 20 healthy volunteers. Methods A single oral dose of zidovudine test and reference were given according to a randomized two way cross - over design. Plasma concentration of zidovudine （300 mg） was determined by HPLC. Results Mean pharmaeokinetie parameters after oral administration of zidovudine test and reference were as follows ： t1/2 were （ 1.72 ±0.45 ）, （ 1.53± 0.27 ） h ; tmax were （0.86±0.42）, （0.88±0.30） h; Cmax were （1.60±0.61）, （1.60±0.56）μg·mL^-1 ; AUC0-8 were （2.06±0.36）, （2.08 ±0.34）μg·h·mL^-1; AUC0-∞ were （2. 11 ±0.36）, （2. 12 ±0.34） μg·h·mL^-1. The bioavailability of zidovudine test to reference was （99.02 ± 5.02 ） %. Conclusion The results demonstrated that the test and reference of zidovudine capsules were bioequivalent.

关 键 词：齐多夫定胶囊 药代动力学 生物等效性 高效液相色谱 

分 类 号：R969.1[医药卫生—药理学] R978.7[医药卫生—药学]