摘要
Abstract
OBJECTIVE: To compare pharmacokinetic parameters of different batches of Cilostazol tablets. METHODS: A single oral dose of different batches of Cilostazol tablets produced by China Dazhong Pharmaceutical Limited Company was administered in 18~22 healthy volunteers and the blood concentrations of cilostazol were determined by HPLC. The pharmacokinetic parameters were calculated by 3p97 pharmacokinetic program. RESULTS: The blood concentration-time curves of 5 batches of Cilostazol tablets fitted to two-compartment model. Main pharmaceutical parameters were as follows: Cmax(0.99 ± 0.37) ug·mL-1, (0.87±0.38)ug·mL-1,(0.81 ±0.27)ug·mL-1,(0.92±0.30)ug·mL-1 and (1.09±0.46)ug·mL-1; tmax(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; AUC0~48 h( 12.84±4.10)ug·h·mL-1, (11.0713.72) ug·h·mL-1, (10.77±3.39) ug·h·mL-1, (10.65 ± 2.44)ug·h·mL-1 and (11.09 ±4.09) ug·h·mL-1, respectively. There was no significant difference in main pharmacokinetic parameters in f-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.关键词
西洛他唑片/不同批次/药动学/参数Key words
Cilostazol tablet/ Different batches/ Pharmacokinetics/ Parameters分类
医药卫生
