摘要
目的:研究比较国产苯扎贝特胶囊与片剂在健康人体的生物利用度和生物等效性。方法:20名健康志愿者按体重随机、配对交叉单次口服400mg试验制剂苯扎贝特胶囊和参比制剂苯扎贝特片剂,洗脱间隔为1周。于服药后各时间点采血3mL,用高效液相色谱法检测药物浓度。用DAS软件计算苯扎贝特胶囊的药动学参数,进行等效性检验。结果:经药动学参数计算其参比制剂与试验制剂的主要药动学参数分别为:t1/2(1.9±0.5)、(2.0±0.6)h;Cmax(12±4)、(11±3)μg/mL;tmax(1.7±0.9)、(1.9±0.7)h;AUC(0-12)(36±10)、(33±7)μg.mL-1.h;AUC(0-∞)(37±10)、(34±7)μg.mL-1.h。试验制剂苯扎贝特胶囊的相对生物利用度F为92.3%,F’为92.9%。结论:苯扎贝特胶囊与片剂生物等效。
AIM: To study the bioavailability and bioequvilence of bezafibrate capsule and tablet in health human. METHODS: 20 health volunteers were given bezafibrate capsules and tablets 400 mg once with the interval of one week. Plasma samples were obtained and determined with HPLC method. Pharmacokinetics parameters were calculated and compared with DAS software. RESULTS: The main pharmacokinetics parameters of bezafibrate capsules and tablets were as follow: t1/2(1.9±0.5),(2.0±0.6) h; Cmax(12±4), (11±3) μg/mL; tmax (1.7±0.9), (1.9±0.7) h; AUC(0-12) (36±10), (33± 7 ) μg·mL^-1·h; AUC(0-∞) (37±10),(34±7) μg·mL^-1·h. The biovailability of bezafibrate capsule campared to tablet was 92.3 % and 92.9%. CONCLUSION: The test bezafibrate capsule is bioequivalent to the reference talbet in health human.
出处
《中国临床药理学与治疗学》
CAS
CSCD
2008年第3期315-319,共5页
Chinese Journal of Clinical Pharmacology and Therapeutics