雷米普利片在健康人体的药代动力学和相对生物利用度

Pharmacokinetics and relative bioavailability of ramipril tablets in healthy people

目的研究样机国产与进口雷米普利片在健康人体的药代动力学和相对生物利用度。方法 30例健康受试者随机分为试验组和对照组,分别服用国产雷米普利片和进口分装雷米普利片,剂量均为10 mg。血样经预处理后采用高效液相色谱(HPLC-MS)法测定。结果在药代动力学各个参数上,国产与进口制剂药物间均无显著性差异(P>0.05)。国产制剂的平均相对生物利用度雷米普利为(104.77±21.63)%,雷米普利拉为(102.57±22.54)%。结论国产和进口雷米普利片在药代动力学上无显著差异。

Objective To study the pharmacokinetics and relative bioavailability of domestic and imported prototype ramipril tablets in healthy people. Methods 30 healthy people were ran- domly divided into experimental group and control group. The domestic and imported ramipril tablets with the dose of 10 mg were given to 2 groups respectively. High performance liquid chro- matography method （HPLC- MS） was applied to detect blood samples. Results There were no significant differences between the domestic and imported preparations in terms of pharmacokinetics parameters （P 〉 0.05 ）. The average relative biological availability of the domestic ramipril and ramiprilat was （104.77 ± 21.63） % and （ 102.57 ± 22.54） % respectively. Conclusion There are no differences between domestic and imported ramipril tablets on pharmacokinetics.