头孢氨苄胶囊在人体药代动力学及其相对生物利用度的研究

Assessment of relative bioavailability and pharmacokinetics of cefalexin capsule

目的 :研究头孢氨苄胶囊在人体内的药物动力学及其相对生物利用度。方法 :18名健康志愿者单剂量口服不同生产厂家的头孢氨苄胶囊 ,以反相高效液相色谱法测定其血药浓度经时过程。结果 :受试制剂和参比制剂中头孢氨苄主要药物动力学参数分别为 :Tmax为 (1.14± 0 .31)、(0 .83± 0 .2 3) h,cmax为 (18.81± 5 .16 )、(2 1.2 4± 4 .71)μg/ m l,t1 /2β为 (1.95±0 .11)、(1.89± 0 .11) h,AUC为 (47.85± 7.33)、(46 .91± 7.15 )μg· h· m l- 1 。 结论 :被试制剂与参比制剂是生物等效制剂。

Objective: To study the pharmacokinetics and bioavailability of cefalexin capsule. Methods: The randomized, crossed-over study was conducted in 18 healthy volunteers. After a single dose of cefalexin 500 mg, the plasma drug levels were determined by RP-HPLC. Results: The main pharmacokinetic parameters of cefalexin tested and control praperations were as follows: T max was (1.14±0.31) and (0.83±0.23) h; c max was (18.81±5.16) and (21.24±4.71) μg/ml; t 1/2β was (1.95±0.11) and (1.89±0.11) h;AUC 0～∝ was (47.85±7.33) and (46.91±7.15) μg·h·ml -1 respectively. Conclusion: The results show that the two praperations are bioequivalent.