摘要
目的 :比较头孢克肟分散片与头孢克肟颗粒剂在健康志愿者体内的药动学及生物等效性。方法 :采用开放、随机、自身交叉对照试验法 ,用RP HPLC法测定血清中头孢克肟的浓度 ,并拟合药动学参数 ,以双单侧t检验法比较两种头孢克肟制剂AUC、Cmax和Tmax间的差异。结果 :头孢克肟分散片与头孢克肟颗粒剂在健康志愿者体内的药时曲线均符合一级吸收的单室开放模型 ,主要药动学参数 :Tmax分别为 ( 3 .5± 0 .5 )和 ( 3 .2± 0 .4)h ,Cmax(实测值 )为 ( 3 .0± 0 .5 )和 ( 3 .1± 0 .4)mg·L- 1 ,AUC( 0～ 2 4h) 分别为 ( 2 6.8± 4.7)和 ( 2 8.5± 3 .1)mg·h·L- 1 。两种头孢克肟制剂各主要药动学参数间均无统计学差异 (P >0 .0 5 ) ,头孢克肟分散片对头孢克肟颗粒剂的相对生物利用度为 94.0 %。结论 :两种头孢克肟制剂具有相同的生物效应。
OBJECTIVE To compare the pharmacokinetic parameters and relative bioavailability of dispersion tablets of cefixime and cefixime granules.METHODS An open,randomizd,two period crosover study with a one week washout interval was conducted in 18 healthy volunteers after single dosage take orally 200 mg cefixim. Concentrations of cefixim in serum were assayed by RP HPLC method.The pharmacokinetics parameters were calculated.The AUC, C max and T max were analyzed by two one sidedt test. RESULTS The concentration time course after medication conformd to a one compartment open model with a first order absorption.The T max , C max and AUC (0～24 h) of dispersion tablets of cefixime and cefixime granules were ( 3.5 ± 0.5 ) and ( 3.2 ± 0.4 )h;( 3.0 ± 0.5 )和( 3.1 ± 0.4 )mg·L -1 ;( 26.8 ± 4.7 )和( 28.5 ± 3.1 )mg·h·L -1 , respectively.Main pharmacokinetics parameters of cefixime suspension and cefixime granules were corresponding ( P > 0.05 ).The relative bioavailability of dispersion tablets of cefixime and cefixime granules was 94.0% .CONCLUSIONS Two preparation was bioequivalnt.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2003年第7期388-390,共3页
Chinese Journal of Hospital Pharmacy
