头孢丙烯胶囊人体药动学及生物等效性研究

 目的在中国健康成年男性志愿者中比较研究国产胶囊剂和合资头孢丙烯片剂的药动学参数,评估两者的生物等效性。方法采用2制剂双周期交叉试验设计,20名受试者分别单剂量口服受试制剂头孢丙烯胶囊和参比制剂头孢丙烯片500mg,用HPLC-UV测定血浆中头孢丙烯的含量,所得参数经3P97软件计算药动学参数并考察生物等效性。结果头孢丙烯片与头孢丙烯胶囊的t_max分别为(1.7±0.3),(1.6±0.2)h;ρ_max分别为:(4.45±1.25),(4.39±1.12)mg·L^-1,AUC_0-12分别为(12.11±2.62),(11.72±2.73)mg·h·L^-1,t_1/2分别为(1.89±0.45),(1.82±0.33)h。各药动学参数无显著性统计学差异(P>0.05),头孢丙烯胶囊的相对生物利用度为(96.9±10.2)%。结论2种头孢丙烯制剂具有生物等效性。

Pharmacokinetics and Bioequivalence of Ioxoprofen Sodium Capsules in Chinese Healthy Volunteers

OBJECTIVE To evaluate the pharmacokinetics and relative bioequivalence of domestic Ioxoprofen Sodium capsules (test) and imported tablets (reference) in Chinese healthy volunteers. METHODS 20 Healthy male volunteers randomly received with a single crossover dose of 500 mg ioxoprofen sodium test or reference prepreation ioxoprofen sodium concentrations in the serum were determined by HPLC-UV. The pharmacokinetic parameters of ioxoprofen sodium were analyzed using 3P97 program. RESULTS Ioxoprofen sodium parameters of the capsules and references preparations tablets were as follows:t_max(1.7±0.3), (1.6±0.2)h;ρ_max(4.45±1.25),(4.39±1.12)mg·L^-1;AUC_0-12:(12.11±2.62),(11.72±2.73)mg·h·L^-1;t_1/2:(1.89±0.45),(1.82±0.33)h;The result of statistical analysis showed no significant differences between the two formulations (P>0.05). The relative bioavailability of the ioxoprofen sodium capsules was (96.9±10.2)%. CONCLUSION The two preparations are bioequivalent.