头孢克罗胶囊人体相对生物利用度研究  

Study on Relative Bioavailability of Cefaclor Capsules in Human Body

作　　者：胡领[1] 姚金成[2] 张毕奎[1] 赵绪元[1] 李焕德[1] 

机构地区：[1]中南大学湘雅二医院药剂科,长沙市410011 [2]湖南中医学院,长沙市410007

出　　处：《中国药房》2005年第15期1160-1161,共2页China Pharmacy

摘　　要：目的:评价头孢克罗胶囊2种制剂的生物等效性。方法:采用高效液相色谱法测定受试者随机交叉单剂量口服头孢克罗胶囊受试制剂或参比制剂后不同时刻的血药浓度。Cmax、tmax采用实测值,AUC用梯形面积法计算,用双单侧t检验评价2种制剂的生物等效性。结果:受试制剂与参比制剂的AUC0～4分别为(13.44±3.06)、(14.19±3.28)(μg·h)/ml;AUC0～∞分别为(13.80±3.08)、(14.62±3.33)(μg·h)/ml;Cmax分别为(11.65±2.39)、(12.37±2.41)μg/ml;tmax分别为(0.57±0.24)h、(0.66±0.19)h;受试制剂的相对生物利用度为(95.62±13.51)%。结论:2种制剂具有生物等效性。OBJECTIVE： To evaluate the relative bioavailability of 2 kinds of preparations of cefaclor capsules. METHODS： The subjects＇ blood concentrations were determined by HPLC at different time after administered randomly crossover with single oral dose of cefaclor testing preparation or reference preparation. The actual values of Cmax and Tmax were adopted ;AUC was calculated by trapezoid planimetry; the bioequiavailability of the 2 preparations were evaluated by two-sides and one-side t-test. RESULTS： The AUC0-4 of the testing preparation and reference preparation were respectively（13.44±3.06） （μg·h）/ml and （14.19±3.28） （μg·h）/ml;their respective AUC0-∞ were （13.80±3.08）（μg·h）/ml and（14.62±3.33）（μg·h）/ml;their respective Cmax were （11.65±2.39） μg/ml and （12.37±2.41）μg/ml;their respective tmax were （0.57± 0.24）h and （0.66±0.19）h. The relative bioavailability of testing preparation was （95.62±13.51）%. CONCLUSION：The 2 preparations are bioequivalent.

关 键 词：头孢克罗 高效液相色谱法 相对生物利用度 

分 类 号：R978.11[医药卫生—药品]