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目的 研究头孢羟氨苄分散片与颗粒剂的相对生物利用度。方法 采用高效液相色谱法(HPLC)测定18名男性健康志愿者单剂量交叉口服500mg头孢羟氨苄分散片与颗粒剂后的血药浓度，计算两者的相对生物利用度。结果 头孢羟氨苄分散片与颗粒剂的Tmax分别为(1..61±0..44)h和(1..58±0..35)h；Cmax分别为(16..0±2..06)mg/L和(16..4±1..99)mg/L;t１／２分别为(2..22±0..26)h和(2..22±0..26)h；药时曲线下面积AUC分别为(60..2±9..79)mg·h/L和(60..7±9..76)mg·h/L；头孢羟氨苄分散片相对生物利用度为(99..3±6..51)%。结论 两种制剂具有生物等效性。
Objective To study the relative bioavailability of cefadroxil dispersible tablets and granules. Methods The plasma concentrations of cefadroxil dispersible tablets and granules after administration of a single dose of 500 mg were determined by high performance liquid chromatography (HPLC) in 18 male healthy volunteers. The relative bioavailability of the two drugs was calculated. Results The Tmax values of cefadroxil dispersible tablet and granule were (1..61 ± 0..44) h and (1..58 ± 0..35) h, respectively; Cmax were (16 ± 0 ± 2). .06) mg / L and (16..4 ± 1..99) mg / L, respectively; t1 / 2 was (2..22 ± 0..26) h and (2..22 ± 0..26 ) h; the area under the curve of AUC was (60..2 ± 9..79) mg · h / L and (60..7 ± 9..76) mg · h / L, respectively; the cefadroxil dispersible tablets The relative bioavailability was (99..3 ± 6..51)%. Conclusions Both formulations are bioequivalent.