市售不同批次西洛他唑片人体药动学参数比较

目的:比较市售不同批次西洛他唑片的人体药动学参数。方法:18～22名健康志愿受试者单剂量口服中国大冢制药有限公司生产的不同批次西洛他唑片后,用高效液相色谱法测定血药浓度,以3p97计算机软件计算药动学参数。结果:该厂生产的5个批次西洛他唑片在人体内的药-时曲线均符合二室模型,主要药动学参数分别为:cmax(0.99±0.37)、(0.87±0.38)、(0.81±0.27)、(0.92±0.30)、(1.09±0.46)μg·mL-1,tmax(3.88±1.19)、(3.22±1.26)、(3.33±1.50)、(3.28±0.96)、(3.05±1.05)h,AUC0～48h(12.84±4.10)、(11.07±3.72)、(10.77±3.39)、(10.65±2.44)、(11.09±4.09)μg·h·mL-1。主要药动学参数经t检验,无显著性差异。结论:该厂家生产的不同批次的西洛他唑片在人体内的药动学过程基本一致,质量稳定,可用作西洛他唑片仿制药品的参比制剂。

Comparison of Pharmacokinetic Parameters of Different Batches of Cilostazol Tablets

OBJECTIVE：To compare pharmacokinetic parameters of different batches of Cilostazol tablets.METHODS：A sin-gle oral dose of different batches of Cilostazol tablets produced by China Dazhong Pharmaceutical Limited Company was adminis-tered in 18～22 healthy volunteers and the blood concentrations of cilostazol were determined by HPLC.The pharmacokinetic pa-rameters were calculated by 3p97 pharmacokinetic program.RESULTS：The blood concentration-time curves of 5 batches of Cilo-stazol tablets fitted to two-compartment model.Main pharmaceutical parameters were as follows：c max（0.99±0.37）μg·mL-1,（0.87±0.38）μg·mL-1,（0.81±0.27）μg·mL-1,（0.92±0.30）μg·mL-1 and（1.09±0.46）μg·mL-1 ;t max（3.88±1.19）h,（3.22±1.26）h,（3.33±1.50）h,（3.28±0.96）h and（3.05±1.05）h;AUC 0～48 h（12.84±4.10）μg·h·mL-1,（11.07±3.72）μg·h·mL-1,（10.77±3.39） μg·h·mL-1,（10.65±2.44）μg·h·mL-1 and（11.09±4.09）μg·h·mL-1,respectively.There was no significant difference in main pharmacokinetic parameters in t-test.CONCLUSION：Pharmacokinetics of different bathes of Cilostazol tablets are in substantial agreement and stable in quality,and it can be used for reference preparation of imitative Cilostazol tablets.