论文部分内容阅读
目的:研究广州某公司提供的盐酸贝那普利片人体相对生物利用度,并与市售盐酸贝那普利片(洛汀新)比较生物等效性。方法:24名健康男性受试者采用随机交叉给药方案,分别单剂量口服40mg贝那普利片和参比片,采用液相色谱方法测定血浆样本中贝那普利及其代谢产物贝那普利拉的浓度,采用DAS软件计算药动学参数。结果:对于原药贝那普利,受试制剂相对于参比制剂生物利用度F为(103.0±25.9)%。对于代谢物贝那普利拉,受试制剂相对于参比制剂的AUC0→t的比值为(97.6±19.6)%。方差分析显示,无论是原药还是代谢物,受试制剂与参比制剂的Cmax、AUC0-t、AUC0→∞均无显著性差异。结论:受试制剂与参比制剂具有生物等效性。
OBJECTIVE: To study the relative bioavailability of benazepril hydrochloride tablets in a company in Guangzhou and to compare the bioequivalence with benazepril hydrochloride (Lotensin hydrochloride) in the market. Methods: Twenty-four healthy male subjects were randomized to receive oral administration of 40 mg benazepril tablets and reference tablets. Plasma samples were analyzed for benazepril and its metabolite Benazepril Pilar concentration, the use of DAS software to calculate pharmacokinetic parameters. Results: For the original drug benazepril, the bioavailability F of the test formulation relative to the reference formulation was (103.0 ± 25.9)%. For the metabolite benazeprilat, the ratio of AUC 0 to t of the test formulation relative to the reference formulation was (97.6 ± 19.6)%. Analysis of variance showed that there was no significant difference in Cmax, AUC0-t, AUC0 → ∞ of the tested and reference preparations, no matter the original drug or the metabolite. Conclusion: The test preparation and the reference preparation are bioequivalent.