摘要
目的 评价地红霉素片剂的生物等效性。方法 20名健康受试者随机交叉、单剂量口服国产地红霉素(试验片)和进口地红霉素(参比片)0.5g,用微生物方法测定血清中地红霉素浓度。结果 2制剂t1/2β分别为35.56±12.12和30.02±13.28 h,tmax分别为4.3±1.0和4.9±0.15 h,Cmax分别为0.50±0.14和0.50±0.15 mg·L-1,AUC0-48分别为2.59±0.46和2.60±0.39 mg·h·L-1。试验药和参比药相比,相对生物利用度为(100.25±15.65)％,90％可信限为92.95％～105.57％,生物利用度符合要求。结论 国产与进口地红霉素具有生物等效性。
Objective To study the pharmacokinetics and bioequivalence of the tested and referenced dirithromycin tablets in 20 healthy volunteers. Methods According to the crossover design, each volunteer was orally given 500mg dirithromycin. The serum concentrations were determined by microbioassay. Pharmacokinetic parameters were obtained using DAS programe .Results After a single oral dose 0.5g, t1/2β were 35.56 ±12.12 and 30.02 ±13.28h , Cmax were 0.50 ±0.14, 0.50 ±0.15 mg·L-1 at 4.3 ±1.0 and 4.9±0.15 h and AUC0-48 was 2.59 ±0.46 and 2.60 ±0.39 mg·h-L-1 for domestic and imported tablets, respectively. Relative bioavailability of the tested dirithromycin was(100.25 ±15.65)%. Conclution The result show that two tablets are bioequivalent.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2004年第3期193-195,共3页
The Chinese Journal of Clinical Pharmacology
关键词
地红霉素
微生物法
相对生物利用度
生物等效性
dirithromycin tablet
microbioassay
relative bioavailability
bioequivalence
