头孢氨苄胶囊的人体生物等效性研究

Study on Bioavailability of Cefalexin Capsule

目的研究不同厂家的头孢氨苄胶囊在人体内的生物等效性。方法对18名健康志愿者单剂量口服给予不同生产厂家的头孢氨苄颗粒,以高效液相色谱法测定其血药浓度经时过程。结果受试制剂与参比制剂中头孢氨苄主要药代动力学参数达峰时间(Tmax)分别为(56.67±18.23)min和(61.67±24.62)min,峰浓度(Cmax)分别为(31.08±6.41)μg/mL和(29.95±6.56)μg/mL,0～300min药时曲线下面积(AUC0-300)分别为(3074.56±516.01)μg/(mL·min)和(3069.21±469.81)μg/(mL·min)。结论受试制剂与参比制剂具有生物等效性。

Objective To study the bioavailability in vivo of Cefalexin Capsule. Methods The randomized, crossedover study was conducted in 18 healthy volunteers. After a single dose of cefalexin 500 mg, the plasma drug levels were determined by HPLC. Results The main pharmacokinetic parameters in the test and reference praperations of cefalexin were as follows： Tmax was （56.67± 18.23）min and （61.67 ± 24. 62）min; Cmax was （31.08 ±6.41）μg/mL and （29.95 ±6.56） μg/mL; AUC0-300 was （3 074. 56 ±516.01）μg/（mL.min） and （3 069.21 ± 469.81）μg/（mL.min）. Conclusion The test and reference preparations are bioequivalent.