克拉霉素片剂人体生物利用度研究  

Studies on the bioavailibility of clarithromycin tablet in human

作　　者：高科攀[1] 史振祺[1] 蒋新国[1] 

机构地区：[1]复旦大学药学院药剂学教研室,上海200032

出　　处：《中国现代应用药学》2004年第1期38-40,共3页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的　对国产克拉霉素片进行相对生物利用度研究 ,评价其生物等效性 ,为临床用药有效性提供实验依据。方法　4 8名健康志愿者随机交叉单剂量口服 5 0 0mg克拉霉素试验制剂和参比制剂 ,采用微生物检定法测定血药浓度 ,生物等效性采用三因素方差分析和双单侧t检验。结果　试验制剂和参比制剂的药物动力学参数Cmax,Tmax,T1/ 2 ,AUC0 ∞ 分别为(3.16± 0 .71) μg/mL和 (3.0 1± 0 .87) μg /mL ,(1.4 6± 0 .5 9)h和 (1.72± 0 .5 7)h ,(5 .4 5± 0 .98)h和 (5 .4 9± 1.2 8)h ,(2 6 .2 2± 4 .2 6 ) μg·h/mL和 (2 5 .5 0± 5 .2 9) μg·h/mL。试验制剂的相对生物利用度为 (10 6± 2 0 ) %。 结论　两种制剂具有生物等效性。OBJECTIVE To study the relative biovailibility of domestic clarithromycin tablet, evaluate its bioequivalence so as to make better clinical use of it. METHOD Forty-eight healthy volunteers were orally given domestic clarithromycin tablet(test preparation) and imported tablet(reference preparation) with a single dosage of 500mg in a randomized crossover study. The serum concentrations of clarithromycin were determined by microbioassay. The bioequivalence was evaluated by three factors analysis of variance and two one-side t test.RESULTS The pharmacokinetic parameters of test or reference prepartion were as follows: C max: (3.16±0.71)μg/mL or (3.01±0.87)μg /mL, T max: (1.46±0.59)h or (1.72±0.57)h, T 1/2: (5.45±0.98)h or (5.49±1.28)h, AUC 0-∞:(26.22±4.26)μg·h/mL or (25.50±5.29)μg·h/mL. The relative bioavailibility of test preparation was (106±20)%.CONCLUSION The two preparations were bioequivalent.

关 键 词：克拉霉素 生物利用度 生物等效性 微生物管碟检定法 

分 类 号：R978.15[医药卫生—药品] R945.1[医药卫生—药学]