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目的：测试国产头孢克洛分散片在８名健康男性志愿者体内的药代动力学和相对生物利用度。方法：采用ＨＰＬＣ法测定血、尿药浓度，比较了单剂量口服５００ｍｇ头孢克洛分散片和普通胶囊的体内过程和生物利用度。结果：头孢克洛分散片的药代动力学符合一室开放模型。试验药品和对照药品的ｃｍａｘ分别为（１５．８７±４．５４）和（１３．７５±４．５４）μｇ／ｍｌ；ｔｍａｘ分别为（０．６３±０．１９）和（０．６６±０．１９）ｈ；ｔ１／２分别为（０．５４±０．１３）和（０．６３±０．２０）ｈ；ＡＵＣ０～∞分别为（１９．１３±２．８２）和（１８．３０±３．６２）ｈ·μｇ／ｍｌ。试验药品的相对生物利用度为（１０６．５９±１９．１３）％。结论：两种制剂的ＡＵＣ及其对数形式经三因素方差分析和双单侧ｔ检验均无显著性差异，提示两者具有生物等效性。
Objective: To test the pharmacokinetics and relative bioavailability of domestic cefaclor dispersible tablets in 8 healthy male volunteers. Methods: The concentrations of blood and urine were determined by HPLC. The in vivo process and bioavailability of single oral dose of 500 mg cefaclor dispersible tablets and ordinary capsules were compared. Results: The pharmacokinetics of cefaclor dispersible tablets conform to the one-compartment open model. The cmax of the test drug and the control drug were (15.87 ± 4.54) and (13.75 ± 4.54) μg / ml respectively; the tmax were (0.63 ± 0.19) and (0.66 ± 0.19) h; t1 / 2 were (0.54 ± 0.13) and (0.63 ± 0.20) h respectively; AUC0 ~ ∞ were (19.13 ± 2.82) and 30 ± 3.62) h · μg / ml. The relative bioavailability of test drugs was (106.59 ± 19.13)%. Conclusion: There is no significant difference of AUC and logarithmic forms between the two preparations by three-factor analysis of variance and double unilateral t-test, suggesting that the two preparations have bioequivalence.