摘要
目的研究消糖灵微丸与胶囊中格列本脲的人体生物等效性。方法选择20名健康受试者,采用双周期两制剂自身交叉单剂量口服消糖灵微丸和胶囊,用高效液相色谱法测定血药浓度,用3P97软件计算药代动力学参数并进行等效性分析。结果格列本脲在消糖灵微丸中与胶囊中的峰浓度(Cmax)分别为(50.50±13.47)ng/mL和(52.77±16.13)ng/mL,达峰时间(Tmax)分别为(2.25±0.39)h和(2.31±0.52)h,0~12 h药时曲线下面积(AUC0-12)分别为(183.04±60.83)ng.h/mL和(188.00±60.44)ng.h/mL,AUC0-inf分别为(198.98±69.69)ng.h/mL和(196.24±62.76)ng.h/mL。以AUC0-12计算的试验制剂的相对生物利用度为(102.0±33.9)%。结论试验制剂与对照制剂具有生物等效性。
Objective To study the bioequivalence of glibenclamide in Xiaotangling Pellets and Xiaotangling Capsules.Methods A single oral dose(2.1 mg tested and reference formulation) was given to 20 healthy volunteers in a randomised crossover study.The concentrations of glibenclamide in plasma were determined by HPLC.Results After taking a single dose,the pharmacokinetic parameters for glibenclamide in Xiaotangling Pellets as compared with those of Xiaotangling Capsules were Cmax(50.50 ± 13.47) ng/mL and(52.77 ± 16.13) ng/mL,Tmax(2.25 ± 0.39) h and(2.31 ± 0.52) h,AUC0-12(183.04 ± 60.83) ng.h/mL and(188.00 ± 60.44) ng·h/mL,AUC0-inf(198.98 ± 69.69)ng·h/mL and(196.24 ± 62.76) ng·h/mL.The relative bioavailability is(102.0 ± 33.9)%.Conclusion The results of the statis-tic analysis show that the two formulations are bioequivalent.
出处
《中国药业》
CAS
2010年第19期10-11,共2页
China Pharmaceuticals
关键词
消糖灵
生物等效性
血药浓度
Xiaotangling
bioequivalence
blood drug concentration