食物对奥扎格雷钠口服液人体内吸收的影响

Effects of Food on Absorption of Ozagrel After Oral Administration in Healthy Volunteers

目的考察食物对奥扎格雷钠口服液药动学影响。方法采用双周期实验设计,选用6名健康志愿者空腹和进食后po200 mg奥扎格雷钠,建立HPLC测定奥扎格雷钠的血药浓度并计算药动学参数,进而对主要药动学参数进行统计分析。结果空腹与进食后的主要药动学参数AUC0-t分别为(3.76±1.15)与(4.13±0.42)mg.h.L-1,AUC0-∞分别为(3.97±1.19)与(4.46±0.61)mg.h.L-1,ρmax分别为(3.61±1.16)与(1.11±0.20)mg.L-1,tmax分别为(0.42±0.13)与(2.75±1.08)h。结论空腹与进食后给药的主要药动学参数ρmax,tmax,AUC0-∞,AUC0-t采用Excel进行成对t检验。ρmax,tmax具有极显著差异(P<0.01)。AUC0-∞,AUC0-t无差异(P>0.05)。

OBJECTIVE To evaluate the effect of food on absorption of ozagrel in 6 healthy volunteers. METHODS In a two period study, 6 healthy male volunteers received a single dose of 200 mg ozagrel either after a fast or after a breakfast. The plasma concentrations of ozagrel were determined by HPLC. The pharmacokinetic parameters of ozagrel were calculated and analyzed with statistical method. RESULTS The main pharmacokinetic parameters of ozagrel after an overnight fast and after a breakfast were as follows： AUC0-t （3.76 ± 1.15） and（4. 13 ±0.42）mg . h^-1. L^-1 , AUC0-∞ （3.97 ± 1.19） and（4. 46 ±0. 61 ）mg . h . L^-1 ,pmax（3. 61 ± 1. 16） and （1. 11 ±0.20）mg . L^-1 ,tmax（0.42 ±0. 13）and（2.75 ±1.08）h, respectively. CONCLUSION The results of statistical analysis showed that there was significant difference on pmax tmax （ P 〈 0. 01 ） and there was no significant difference on AUC0-∞ , AUC0-t （ P 〉 0.05） and between after an overnight fast and after a breakfast.