三种头孢克洛胶囊的生物等效性研究

Bioequivalence of Three Kinds of Cefaclor Capsules

以盐野义制药株式会社的头孢克洛缓释胶囊 (B)和 L illy公司的头孢克洛普通胶囊 (C)为参比制剂 ,在 12名男性健康受试者中对国产头孢克洛缓释胶囊 (A)进行了生物等效性及药物动力学研究。采用反相高效液相色谱 -紫外检测法测定血浆中头孢克洛浓度。 A、B、C三种胶囊的 AUC0→ tn分别为 2 3.87± 4 .11、2 2 .5 3± 4 .37、2 4 .14± 2 .87μg· ml- 1 · h,A与 B各参数均无显著性差异 ,与 C相比 ,Cmax明显降低 ,血浆浓度维持 MIC以上时间延长 1.83倍 。

The bioequivalence of three kinds of cefaclor capsules (A:domestic sustained release capsules, B:import sustained release capsules, C:import conventional capsules) was investigated in 12 healthy man volunteers. The single oral dose of 750 mg cefaclor capsules was administered according to a randomized three way crossover design. The plasma concentrations of cefaclor were determined by RP HPLC with UV detection. The areas under the drug concentration time curves ( AUC 0→tn ) of A、B、C were 23.87± 4.11、 22.53±4.37、24.14±2.87 μg·ml -1 ·h, respectively. Compare with C, the C max of A was lower, and the time of above MIC was longer. The results showed that A was bioequivalence with B and C, and has significantly sustained release characteristic.