摘要
目的 评价头孢克肟片剂、胶囊剂与参比制剂在健康人体内的药代动力 学及其生物等效性。方法用三交叉全排列组合设计,18名健康男性受试者 交叉单剂量口服试验药头孢克肟片、胶囊和对照药头孢克肟胶囊剂,用高效液 相色谱法测定其的血药浓度。结果受试制剂头孢克肟片、胶囊与对照药头孢 克肟胶囊的Cmax分别为:(1．64±0．45),(1．58±0．37)和(1．67±O．46)μg· mL-1;tmax分别为:(3．78±0．38),(3．75±0．34)和(3．86±0．28)h;AUC0-24分 别为:(13．58±3．78),(13．49±3．63)和(13．36±4．16)mg·h·L-1;AUC0-∞ 分别为:(14．49±3．94),(14．32±3．87)和(14．05±4．31)mg·h·L-1。经统 计学分析,3组间均无显著性差异(P>0．05)。结论3种制剂具有生物等效 性。
Objective To evaluate the bioequivalence of cefixime tablet and capsules in healthy volunteers. Methods Eiteeng healthy volunteers were enrolled following a single oral dose respectively by randomized tri -crossover design. Plasma concentrations of cifixime were determined by HPLC method. Results The main pharmacokinetic parameters of cifixime tested tablets, capsules and reference capsules were as following ： Cmax were （ 1.64±0. 45） ,（1.58 ±0.37） 和（1.67 ±0.46）μg· ml^-1 ;tmax were （3.78 ± 0.38）,（3.75 ±0.34） and （3.86 ±0.28） h;AUC0-24 were （13.58 ± 3.78）,（13.49 ±3.63） and （13.36 ±4.16）;AUC0-∞ were （14.49 ± 3.94） , （ 14.32 ± 3.87 ） and （ 14.05 ±4.31 ） mg·h·L^ -1, respectively. The parameters among them wes not significant difference （ P 〉 0. 05 ）. Conclusion The results of statistical analysis showed that cefixime tablet and capsules were bioequivalant.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2005年第5期375-377,共3页
The Chinese Journal of Clinical Pharmacology
