头孢克肟颗粒剂和分散片在健康志愿者的相对生物利用度  

Relative bioavailability of cefixime granules and dispersible tablets in human subjects

作　　者：鄢琳 [1] 李铜铃 [1] 张荣琴 [1] 许小红 [1] 郑鹏程 [1] 冯亮 [1] 程强 [1] 李晓松 [2] 

机构地区：[1]四川大学,华西药学院,临床药学教研室,四川,成都,610041 [2]四川大学,华西公共卫生学院卫生统计学教研室,四川,成都,610041

出　　处：《中国临床药理学杂志》2004年第2期109-112,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的 比较头孢克肟颗粒剂及分散片与市售头孢克肟胶囊在健康人体内的相对生物利用度。方法 用反相高效液相色谱法测定2 1名健康受试者单剂量口服400 mg头孢克肟颗粒剂和分散片及胶囊后头孢克肟的血药浓度,3P87程序计算药代动力学参数,Auc、Cmax对数转换后进行方差分析并计算90％可信区间。结果 头孢克肟颗粒剂、分散片和胶囊的主要药代动力学参数为:AUC0分别为29.45±10.67,29.12±10.38和29.53±10.71μg·h·mL-1,AUC0-t分别为28.38±9.94,28.00±9.68和28.58±10.07μg·h·mL-1,tmax分别为3.83±0.37,3.71±0.30和3.79±034 h,Cmax分别为4.79±1.07,4.84土1.04和4.77±1.10μg·mL-1,t1/2分别为2.35±0.42,2.40±0.42和2.27±0.43 h,MRT0-t分别为5.54±0.60,5.50±0.62和5.55±0.66 h。以头孢克肟胶囊为参比,头孢克肟颗粒剂及分散片相对生物利用度F0-t为(99.77±8.74)％和(98.56±9.20)％。F0-8为(100.17±9.1 1)％和(99.14±8.95)％。结论 头孢克肟颗粒剂、分散片与胶囊具有生物等效性。Objective To compare the bioavailability of cefixime granules and dispersible tablets with marketed cefixime capsules in human subjects. Methods A reversed-phase high performance liquid chromatography was used for the determination of cefixime in serum after a single oral dose of 400 mg cefixime granules, dispersible tablets and marketed cefixime capsules in a cross-over design. Results the pharmacokinetic parameters of cefixime granules, dispersible tablets and marketed cefixime capsules were as follows: AUC0-1.were 29.45±10.67,29.12±10.38 and 29.53 ±10.71 μg·h·mL-1; AUC0-t were 28.38 ±9.94, 28.00±9.68 and 28.58 ±10.07 μg·h·mL-1; tmax were 3.83±0.37, 3.71±0.30 and 3.79±?0.34 ; Cmax were 4.79 ±?1.07, 4.84±1.04 and 4.77±10 μg·h·mL-1; t1/2were 2.35±0.42, 2.40 ±0.42 and 2.27 ±0.43 h, MRT0-T were 5.54±0.60, 5.50 ±62 and 5.55±0.66 h. F0-t were (99.77±8.74)% and (98.56±9.20)%; F0-8 were (100.17±9.11)% and (99.14 ±95)%, respectively. Conclusion The cefixime granules and dispersible tablets are bioequivalent with the marketed cefixime capsules.

关 键 词：头孢克肟颗粒剂 分散片 健康志愿者 相对生物利用度 反相高效液相色谱 

分 类 号：R978.11[医药卫生—药品] R969.1[医药卫生—药学]