摘要
18名健康志愿者随机交叉单剂量口服氨甲环酸受试制剂和参比制剂。用LC-MS法检测血浆中药物浓度,计算两种制剂的药动学参数并进行等效性评价。结果表明,受试胶囊和参比片剂的主要药动学参数:tmax为(3.1±0.5)和(3.0±0.5)h,cmax为(10.0±2.4)和(9.5±2.1)μg/ml,t1/2为(2.6±0.2)和(2.6±0.2)h,AUC0→16为(38.9±10.9)和(38.6±11.7)μg·h·ml-1,受试制剂的相对生物利用度为(102.7±13.3)%,表明两种制剂生物等效。
A single dosage randomized cross-over design was used to investigate the pharmacokinetics and bioequivalence of two tranexamic acid preparations in 18 healthy volunteers after oral administration. The drug concentration in plasma was determined by LC-MS. The pharmacokinetic parameters of the test capsules and reference tablets were as follows： tmax were （3.1±0.5） and （3.0±0.5）h, Cmax were （10.0±2.4） and （9.5±2.1）μg/ml, t1/2 were （2.6±0.2） and （2.6±0.2）h, A UC0-6 were （38.9±10.9） and （38.6±11.7）μg·h·ml^-1. The relative bioavailability of the test capsules was （102.7±13.3） %. The result demonstrated that the two preparations were bioequivalent.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2008年第4期273-275,共3页
Chinese Journal of Pharmaceuticals
