雷米普利胶囊在健康人体内的药动学研究

Pharmacokinetics of Ramipril Capsules in Healthy Volunteers

采用单剂量交叉实验设计,考察24名健康受试者口服雷米普利胶囊(受试制剂)及其片剂(参比制剂)5mg后的药物动力学。建立了LC-MS法测定血浆中代谢物雷米普利拉的浓度。采用C18柱,贝那普利为内标,以多反应监测(MRM)模式监测。两种制剂的cmax和tmax分别为(6.42±3.18)、(6.48±3.31)ng/ml和(3.31±1.47)、(3.04±1.14)h。受试制剂的相对生物利用度为(101.72±18.34)%。两者在人体的吸收速度和吸收程度无显著差异,表明两者生物等效。

The pharmacokinetics of 5mg ramipril capsules and tablets which were orally administrated by 24 healthy vohmteers was investigated. A LC-MS method was established for the determination of ramiprilat in plasma. A C18 column was used with benazepril as the internal standard. The analytes were detected in the positive ion mode and multiple reaction monitoring （MRM）. The cmax and tmax of capsules and tablets were （6.42±3.18）, （6.48±3.31） ng/ml and （3.31±1.47）, （3.04±1.14）h, respectively. The relative bioavailability of ramipril capsules was （101.72±18.34） %. No significant difference was observed in rate and degree of absorption, which indicated that the two preparations were bioequivalent.