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健康男性志愿者9名,随机分为两组,间隔一周交叉一次口服头孢克罗片剂和胶囊。高效液相色谱法测定人血清中药物浓度,进行相对生物利用度研究。结果表明:片剂与胶囊的药─时曲线均符合一级吸收的二房室模型,Tpeak分别为37.34±6.01min和39.58±8.26min,Cmax分别为10.38±1.66mg/L和12.41±3.18mg/L,AUC分别为793.44±114.63mg·min(-1)·L(-1)和853.61±133.37mg·min(-1)·L(-1);各参数经配对t-检验处理,均无显著性差异(P>0.05);片剂的相对生物利用度为92.95%。结果提示头孢克罗片剂和头孢克罗胶囊具有生物等效性。
Nine healthy male volunteers were randomized into two groups with oral cefaclor tablets and capsules crossed one week apart. Determination of drug concentration in human serum by high performance liquid chromatography and relative bioavailability. The results showed that the drug-time curves of tablets and capsules were in accordance with the first-order absorption of two-compartment model, Tpeak were 37.34 ± 6.01min and 39.58 ± 8.26min, Cmax were 10.38 ± 1. 66mg / L and 12.41 ± 3.18mg / L, respectively. The AUC were 793.44 ± 114.63mg · min -1 · L -1 and 853.61 ± 133.37mg · min -1, · L (-1). There was no significant difference (P> 0.05) between each parameter by paired t-test. The relative bioavailability of the tablets was 92.95%. The results suggest that cefaclor tablets and cefaclor capsules have bioequivalence.