头孢克罗胶囊的人体相对生物利用度研究

STUDY OF RELATIVE BIOAVAILABILITY OF CEFACLOR CAPSULES IN HUMAN BODY

用高效液相色谱法,测定健康男性志愿者8名,血清中2种头孢克罗胶囊(T药、R药)的药物浓度,进行相对生物利用度研究。结果表明:T药与R药的药-时曲线均符合二房室模型,T_(max)分别为40.97±17.31min和40.41±10.76min,C_(max)分别为11.92±2.66μg·ml^(-1)和13.39±3.92μg·ml^(-1),AUC分别为1086.25±189.70μgg·ml^(-1)·min^(-1)和1007.42±150.75μg·ml^(-1)·min^(-1);各参数经配对t检验处理,均无显著性差异(P>0.05);测试品的相对生物利用度为107.8％。结果提示T药与R药具有生物等效性。

Relative bioavailability of two products of cefaclor capsules (referred to as T and R)in sera of eight healthy male volunteers were determined by high performance liquid chromato-graphy. The results showed that the drug-time curve of the product T and R conformed with the two compartment model. T_(max) was 40.97 ± 17.31min and 40.41 ± 10.76min respectively. Cmax was 11.92±2.66μg-ml-1 and 13.39±3.92μg·ml^(-1), and AUC was 1086.25 ± 189.70μg·ml^(-1). min-1 and 1007.42 ± 150.75μg·ml-1· min-1 respectively. Parameters treated by matched t-test showed no significant difference(P>0.05) . Relative bioavailability of the samples was 107.8% . The results indicated that product T and R were bio-equivalent.