中国药房2011，Vol.22Issue(2)：141-143,3.
3种头孢克洛制剂在健康人体内的药动学及生物等效性研究
Pharmacokinetics and Bioequivalence of 3 Kinds of Cefaclor Preparations in Healthy Volunteers
余俊先 1史丽敏 1王曼丽 1杨春秀 1王汝龙1
作者信息
- 1. 首都医科大学附属北京友谊医院药剂科,北京市,100050
- 折叠
摘要
Abstract
OBJECTIVE: To compare the pharmacokinetics of 3 kinds of cefaclor preparations in healthy volunteers, and to evaluate the bioequivalence of 3 kinds of preparations. METHODS: 18 healthy volunteers received a single dose of 500 mg cefaclor dry suspension (test preparation 1), 500 mg cefaclor dispersible tablets (test preparations 2) or 500 mg cefaclor tablets (reference prepration) respectively. The plasma concentrations of cefaclor were determined by HPLC. The pharmacokinetic parameters and relative bioequivalence of cefaclor were calculated using DAS software. RESULTS: The pharmacokinetic parameters of test preparation 1, test preparation 2 and reference preparation were as follows: cmax( 13.94 ± 3.76) μg· mL-1, (13.54 ± 2.27) μg· mL-1 and (13.86±3.13) μg·mL-1; tmax(0.56 ± 0.13) h, (0.55±0.14) h and (0.51 ±0.13) h; t1/2(0.67± 0.09) h, (0.68±0.15) h and (0.80±0.26) h; AUC0～4(15.16 ± 2.58) μg·h ·mL-1, (14.56± 1.70) μg·h·mL-1 and (14.74±2.07) μg·h ·mL-1. F0～4 of test preparation 1 and test preparation 2 were (103.80 ± 17.80)％ and (100.50 ± 18.40)％. There was no significant difference of cmax、tmax、AUC0～4、AUC0～∞ between 3 kinds of preparations. CONCLUSION: The dry suspension, dispersible tablets and reference tablets of cefaclor arc bioequivalent.关键词
头孢克洛/高效液相色谱法/药动学/生物等效性分类
医药卫生引用本文复制引用
余俊先,史丽敏,王曼丽,杨春秀,王汝龙..3种头孢克洛制剂在健康人体内的药动学及生物等效性研究[J].中国药房,2011,22(2):141-143,3.
