国产与进口罗红霉素片的人体生物等效性研究

目的:研究国产与进口罗红霉素片的人体生物等效性。方法:20名健康男性受试者随机交叉单剂量口服国产或进口罗红霉素片150mg后,采用色谱-质谱联用法测定血浆中的罗红霉素浓度。结果:国产及进口罗红霉素片的AUC0～72分别为(72.81±23.85)、(72.63±20.86)(mg·h)/L,AUC0～∞分别为(74.41±24.45)、(74.42±24.45)(mg·h)/L,Cmax分别为(6.46±1.51)、(6.58±1.55)mg/L,tmax分别为(1.9±0.5)、(1.8±0.5)h,t1/2分别为(13.56±1.35)、(14.18±1.50)h,国产制剂相对于进口制剂的人体生物利用度为(99.8±11.2)%。结论:国产与进口罗红霉素片具有生物等效性。

Study on Bioequiavailability in Human Body between Domestic and Imported Roxithromycin

OBJECTIVE:To study the bioequiavailability of domestic roxithromycin tablets and imported ones.METHˉODS:20male healthy volunteers took single dose of150mg roxithromycin tablet orally in a random crossover design,blood concentrations were determined by LC-MS.RESULTS:The main pharmacokinetic parameters of domestic and imported tablets were determined respectively as follows,AUC 0～72 were(72.81±23.85)(mg·n)/L and(72.63±20.86)(mg·h)/L,AUC 0～∞ were(74.41±24.45)(mg·h)/L and(74.42±24.45)(mg·h)/L,C max were(6.46±1.51)mg/L and(6.58±1.55)mg/L,t max were(1.9±0.5)h and(1.8±0.5)h,t 1/2 were(13.56±1.35)h and(14.18±1.50)h,the relative bioavailability of the homemade tablet to imported one was(99.8±11.2)%.CONCLUSIONS:Domestic and imported roxithromycin are bioequivalent.