摘要
建立了LC-MS/MS法测定人血浆中青霉素V钾的浓度,并研究了20名健康志愿者单剂量随机交叉口服青霉素V钾片0.5g后的药动学和相对生物利用度。青霉素V钾受试制剂与参比制剂的主要药动学参数分别为AUC0-7h(9.61±3.94)和(9.69±4.52)μg·h·ml-1,AUC0-∞(9.72±3.96)和(9.79±4.51)μg·h·ml-1,cmax(8.36±4.14)和(8.47±4.47)μg/ml,tmax(0.53±0.15)和(0.54±0.14)h。受试制剂相对于参比制剂的生物利用度为99.3%,两制剂具有生物等效性。
A LC-MS/MS method was established for the determination of phenoxymethylpenicillin potassium in human plasma. According to a randomized two-period crossover design, the pharmacokinetics and bioequivalence after single dose oral administration of test and reference tablets in 20 healthy volunteers were investigated. The pharmacokinetic parameters of test and reference tablets were as follows： AUC0-7h （9.61±3.94） and （9.69± 4.52） μg·h·ml^-1, AUC0-oc（9.72±3.96） and（9.79±4.51）μg·h·ml^-1, Cmax（8.36±4.14） and （8.47±4.47）μg/ml, tmax （0.53±0.15） and （0.54±0.14） h, respectively. The relative bioavailability of the test preparation was 99.3 %. The two preparations were bioequivalent.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2008年第12期914-917,共4页
Chinese Journal of Pharmaceuticals
