摘要
目的建立测定血浆中司帕沙星的HPLC内标法并研究司帕沙星片的相对生物利用度及生物等效性。方法 20名健康志愿者分两组,随机、交叉口服受试制剂与参比制剂的司帕沙星片0.4 g,HPLC法测定血药浓度,计算药动学参数及生物等效性评价。结果受试制剂与参比制剂血浆中司帕沙星的tmax为(4.68±0.44)和(4.55±0.51)h;Cmax为(1 560.4±243.9)和(1 584.1±273.9)ng/ml;t1/2为(20.92±4.85)和(19.81±3.75)h;用梯形法计算AUC0-t为(43 325±12 174)和(44 139±11 815)ng.h/ml;AUC0-∞为(45 452±12 884)和(45 999±12 629)ng.h/ml。以AUC0-t计算,受试制剂的平均相对生物利用度为(97.9±5.8)%。结论两制剂具有生物等效性。
Objective To determine Sparfloxacin concentrations in human plasma and study the pharmacokinetics and relative bioavailability of Sparfloxacin for Suspension.Methods A single dose reference and test was given to 20 healthy volunteers in a randomized 2-way cross-over study.The plasma Sparfloxacin concentrations were determined by HPLC.The pharmacokinetics as well as relative bioavailability was measured.Results The main pharmacokinetic parameters of two formulations,Sparfloxacin in test and reference drug were as follows： tmax were（4.68±0.44）and（4.55±0.51）h;Cmax were（1 560.4±243.9）and（1 584.1±273.9）ng/ml;t1/2 were（20.92±4.85）and（19.81±3.75）h;AUC0-t were（43 325±12 174）and（44 139±11 815）ng·h/ml;AUC0-∞ were（45 452±12 884）and（45 999±12 629）ng·h/ml respectively.Using DASS program,the results of variance and two one-sided t-test statistical analyses for Ln Cmax.Two formulations were bioequivalent.Conclusion The reference and test Sparfloxacin were bioequivalent.
出处
《药学实践杂志》
CAS
2012年第5期372-375,共4页
Journal of Pharmaceutical Practice
