头孢氨苄片人体药动学及生物利用度  

Relative bioavailability of cefalexin in Chinese healthy volunteers

作　　者：王珍[1] 金锐[1] 于景翠[1] 杜智敏[1] 

机构地区：[1]哈尔滨医科大学第二临床医学院临床药学药物研究所黑龙江省高校重点实验室,黑龙江哈尔滨150081

出　　处：《哈尔滨医科大学学报》2008年第2期183-185,共3页Journal of Harbin Medical University

摘　　要：目的研究广州白云山制药总厂生产头孢氨苄片在健康人体内的血药浓度经时过程及人体生物利用度。方法采用HPLC法测定20名健康受试者单剂量口服1g头孢氨苄片受试制剂及参比制剂后的药动学数据。结果受试制剂与参比制剂药动学参数分别为:Tmax(1.09±0.22)和(1.3±0.41)h,Cmax(70.25±13.92)和(69.89±11.91)mg/L,AUC0→6(128.1±23.2)和(130.4±25.17)mg/h.L。试验制剂相对生物利用度为(98.7±8.9)%。结论两种制剂具有生物等效性。Objective To study the bioavailability of cefalexin manufactoried by Guangzhou Baiyunshan Pharmaceutical factory in 20 young healthy volunteers.Methods Pharmacokinetic parameters were evaluated by HPLC method after a single oral dose of the referenced formulation and the tested formulation among 20 volunteers.Results The pharmacokinetic parameters of cefalexin tablets referenced formulation and the tested formulation were shown as follows：Tmax（1.09±0.22） and（1.3±0.41）h;Cmax（70.25±13.92） and（69.89±11.91）mg/L;AUC0→6（128.1±23.2） and（130.4±25.17）mg/h·L.The pharmacokinetic parameters showed no significant difference between 2 formulations（P〉0.05）.The Relative bioavailability of cefalexin manufactoried by Guangzhou Baiyunshan Pharmaceutical factory was（98.7±8.9）%.Conclusion The tested formulation is bioequivalent with the referenced formulation.

关 键 词：头孢氨苄 药代动力学 生物利用度 

分 类 号：R978.11[医药卫生—药品]