摘要
目的:研究吲达帕胺试验制剂(缓释胶囊)和参比制剂(片剂)的人体药动学和生物等效性。方法:20名健康志愿者按随机双周期交叉试验方案设计,分别口服受试制剂(吲达帕胺缓释胶囊)和参比制剂(吲达帕胺片)1.5mg,采用液相色谱-串联质谱(LC/MS/MS)分析方法测定吲达帕胺的全血浓度。利用DAS程序计算其药动学参数和评价生物等效性。结果:吲达帕胺试验胶囊和参比片剂的主要药动学参数:Cmax分别为(38.2±14.6),(41.1±7.6)μg·L-1;Tmax分别为(11.4±3.3),(8.0±3.0)h;t1/2ke分别为(19.7±2.3),(19.7±2.8)h;AUC0-96分别为(1252.8±404.3),(1267.5±278.8)μg·h·L-1;AUC0-∞分别为(1308.0±424.6),(1319.4±292.4)μg·h·L-1;受试制剂相对生物利用度为(97.5±14.5)%。结论:经方差分析及双单侧t检验结果显示,受试的吲达帕胺胶囊与参比的吲达帕胺片具有生物等效性。
OBJECTIVE To study the pharmacokinetics and bioequivalence of indapamide test capsules and reference tablets in healthy volunteers. METHODS A single oral dose of 1. 5 mg test or reference preparation was given to 20 healthy volunteers in a randomized two-period study. LC/MS/MS method was developed for the determination of indapamide in human whole blood. The pharmacokinetics parameters were obtained by DAS software. RESULTS The main pharmacokinetics parameters of test capsules and reference tablets were as follows： Cmax were （38. 2 ± 14. 6） and （1.1 ± 7. 6） ng·mL^-1＇ ; Tmax were （ 11.4 ± 3.3 ） and （8. 0 ± 3. 0） h; t1/2kc were （ 19. 7 ± 2. 3） and （ 19. 7 ± 2. 8） h; AUC0-96 were （ 1 252.8 ± 404. 3） and （ 1 267. 5 ± 278.8） ng· h· mL^-1 ; AUC0-∞ were （1 308.0 ± 424. 6） and （1 319. 4 ± 292. 4） ng· h· mL^-1. The relative bioavalability of the test capsules was （97. 5 ± 14. 5） %. CONCLUSION The results show that the test capsules of indapaminde and the reference tab tels are bioequivalent.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2008年第24期2106-2110,共5页
Chinese Journal of Hospital Pharmacy
