穿心莲内酯分散片的药动学与生物等效性

Pharmacokinetics and Bioequivalence Evaluation of Andrographolide Dispersible Tablets

采用随机双交叉实验设计,20名健康志愿者分别口服穿心莲内酯(1)分散片(受试制剂)及其片剂(参比制剂)200mg,采用LC-MS/MS法测定血浆中1的浓度。参比制剂和受试制剂的AUC0-∞分别为(290.30±61.34)和(285.53±65.40)ng·h·ml-1;cmax分别为(63.23±18.28)和(58.62±18.41)ng/ml;tmax分别为(1.5±0.4)和(1.6±0.3)h;t1/2β分别为(9.46±2.69)和(10.50±2.07)h。受试制剂的相对生物利用度为(102.2±13.5)%,表明两制剂生物等效。

According to a random crossover design, 20 healthy volunteers single dosage orally administrated andrographolide dispersible tablets （T） and its tablets （R）, respectively. The drug concentration in plasma was determined by LC-MS/MS. The main pharmacokinetic parameters of R and T preparations were AUC0-∞ （290.30±61.34） and （285.53±65.40）ng·h·ml^-1, Cmax （63.23±18.28） and （58.62±18.41）ng/ml, tmax （1.5±0.4） and （1.6±0.3）h, t1/2β （9.46± 2.69） and （10.50±2.07）h, respectively. The relative bioavailability of the test tablets was （102.2±13.5） %. The results demonstrated that the two preparations were bioequivalent.