摘要
目的研究健康受试者单次口服氟氯西林钠胶囊的药代动力学特征。方法健康受试者24名,按3×3拉丁方设计,分别单次口服氟氯西林钠胶囊0.25、0.5、1 g后,采用HPLC法测定血浆中氟氯西林的浓度。用DAS软件程序进行数据处理,用SPSS软件对不同性别药代动力学参数进行统计分析,求算药代动力学参数。结果 3个不同剂量组氟氯西林的主要药代动力学参数:Cmax分别为(8.29±0.51)、(15.93±4.21)、(30.62±9.63)μg/ml,tmax分别为(0.96±0.05)、(0.93±0.07)、(1.03±0.06)h,t1/2分别为(1.24±0.06)、(1.53±0.29)、(1.55±0.28)h,AUC0-10分别为(30.52±9.17)、(60.64±13.26)、(118.39±19.38)μg.h/ml,CL/F分别为(9.03±0.61)、(9.61±0.84)、(9.52±0.82)L/h。各剂量组的C max、AUC0-10、AUC0-∞随剂量的增加而呈比例的增大,各组的Ka、Ke、tmax、t1/2、CL/F等无显著性差异。结论口服不同剂量的氟氯西林钠胶囊,健康受试者体内具有线性药代动力学特征,药代动力学过程符合二室开放模型。
Objective To study the pharmacokinetics of a single dose of flucloxacillin capsules in Chinese healthy volunteers.Methods Twenty-four healthy volunteers were divided into three groups by 3×3 design.The drug concentration of the plasma sample from the twenty-four volunteers after taking 0.25,0.5,1 g flucloxacillin was determined by HPLC.The pharmacokinetic parameters were calculated by DAS software and were statistically analyzed by SPSS software.Results The healthy volunteers were given a single dose of flucloxacillin of 0.25,0.5,1 g,respectively.The main pharmacokinetic parameters were as follows：Cmax was（8.29±0.51）,（15.93±4.21）,（30.62±9.63） μg/ml,tmax was（0.96±0.05）,（0.93±0.07）,（1.03±0.06） h,t1/2 was（1.24±0.06）,（1.53±0.29）,（1.55±0.28） h,AUC0-10 was（30.52±9.17）,（60.64±13.26）,（118.39±19.38） μg · h/ml,CL/F was（9.03±0.61）,（9.61±0.84）,（9.52±0.82）L/h.respectively.The main pharmacokinetic parameters Cmax,AUC0-10,AUC0-∞ were in direct proportion to the dose.There was no singnificant difference in Ka,Ke,tmax,t1/2 and CL/F between the three groups by analysis of variance.Conclusion The pharmacokinetics of flucloxacillin at different dosage in healthy volunteers conforms to the linear dynamic feature.The plasma concentration-time curve of flucloxacillin is fitted to a two-compartment open model.
出处
《解放军药学学报》
CAS
2012年第2期130-132,共3页
Pharmaceutical Journal of Chinese People's Liberation Army
