头孢克罗胶囊人体相对生物利用度研究

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。

Study on Relative Bioavailability of Cefaclor Capsules in Human Body

OBJECTIVE:To evaluate the relative bioavailability of2kinds of preparations of cefaclor capsules.METHˉODS: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 C max and T max were adopted;AUC was calculated by trapezoid planimetry;the bioequiavailability of the2preparations were evaluated by two-sides and one-side t-test.RESULTS:The AUC 0～4 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 AUC 0～∞ were(13.80±3.08)(μg·h)/ml and(14.62±3.33)(μg·h)/ml;their respective C max were(11.65±2.39)μg/ml and(12.37±2.41)μg/ml;their respective t max were(0.57±0.24)h and(0.66±0.19)h.The relative bioavailability of testing preparation was(95.62±13.51)%.CONˉCLUSION:The2preparations are bioequivalent.