头孢呋辛酯片健康人体生物等效性评价

目的考察国产头孢呋辛酯片与参比制剂（西力欣片）在健康人体内的生物等效性。方法采用高效液相色谱法测定血浆中头孢呋辛的质量浓度。通过对20名男性健康受试者单次交叉口服500mg头孢呋辛酯的受试制剂和参比制剂,计算其药代动力学参数及相对生物利用度。结果受试制剂和参比制剂的0～t药时曲线下面积（AUC0-t）分别为（20.206±4.571）μg（/mL·h）和（20.098±4.849）μg（/mL·h）,峰浓度（Cmax）分别为（5.764±1.164）μg/mL和（5.757±1.331）μg/mL,达峰时间（Tmax）分别为（2.225±0.573）h和（2.100±0.598）h,血浆半衰期（t1/2）分别为（1.319±0.166）h和（1.376±0.184）h,受试制剂的相对生物利用度为106.2%。结论受试制剂头孢呋辛酯片与参比制剂生物等效。

Bioequivalence of Cefuroxime Axetil Tablets in Healthy Volunteers

Objective To study the in vivo bioequivalence in healthy people betwe en domestic Cefuroxime Axetil Tablets and the reference ones（Zinacef Tablets）.M ethods The HPLC method was established to determine the concentration of cefurox ime following oral administration 500 mg of the two preparations.A single dosage crossover design was applied and 20 male healthy volunteers were included in th is trial.Then the pharmacokinetic parameters and relative bioavailability were a nalyzed.Results The main pharmacokinetic parameters of tested preparation and re ference preparation were as follows：AUC0-t was （20.206±4.571）μg/（mL·h） and（20.098±4.849）μg/（mL·h）;Cmax was （5.764±1.164）μg/mL and （5.757±1.331）μg/mL ;Tmax was（2.225±0.573）h and （2.100±0.598）h;t1/2 was （1.319±0.166）h and （1.37 6±0.184）h respectively.The relative bioavailability of tested preparation was 1 06.2%.Conclusion Tested Cefuroxime Axetil Tablets is bioequivalent to reference preparation.