摘要
目的 研究2种西洛他唑片在正常人体内的药代动力学与相对生物利用度。方法 用HPLC法测定24名志愿者随机交叉口服2种国产西洛他唑100mg后的血药浓度,用3P97软件计算2药的药代动力学参数与相对生物利度。结果 试验与参比药物的体内药-时曲线呈二室摸型。tmax分别为(3.25±0.99) 和(3.88±1.19) h;Cmax分别为(1.02±0.41)和(0.99±0.37) mg.mL-1;AUC(0-T)分别为(12.65±3.83) 和(12.84±4.10) mg.h.mL-1;t1/2β分别为(19.50±13.72) 和(17.40±11.58) h。经配对t检验,2药药代动力学参数无显著性差异(P>0.05)。西洛他唑片相对生物利用度为 (98.52±13.52)%。结论 2种国产西洛他唑片具有生物等效性。
Objective To study relative bioavailability and pharmacokinetics of thecilostazole tablets in 24 healthy male volunteers. Methods A single dose of 100mgof the test cilostazol or the reference cilostazol was administred by randomizedcross-over way in 24 volunteers and the plasma concentrations of cilostazole weredetermined by HPLC.The pharmacokinetic parameters were calculated with 3P97pharmacokinetic program and the bioequivalency wad evaluated. Results Theconcentration-time curves of two preparation fitted to two-compartment model.Thepeak plasma levels (Cmax) of test or reference were (1.02±.04) and (0.99±0.37) mg.mL-1 respectively, the peak time (tmax) were (3.25±0.99) and (3.88±1.19) h,andAUC0-T were (12.65±3.83) and (12.84±4.10) mg.h.mL-1 respectively. The relativebioavailability of test was (98.52±13.52)%. Conclusion The result of two one-sided tests suggest that the test is bivequivalence with the reference.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2004年第5期363-365,共3页
The Chinese Journal of Clinical Pharmacology
