摘要
目的:比较沙丁胺醇缓释胶囊与普通片的血药浓度及生物利用度.方法:采用同体交叉试验方法,HPLC法测定8名志愿者单剂量和多剂量po 沙丁胺醇缓释胶囊和普通片后的.结果:沙丁胺醇单剂量po后,缓释胶囊和普通片的T_(max).分别为( 4.60士0.63)和(2.39士1.07);C_(max)为(9 70土2.94)和(18.52土3.31)ng/ml;AUC为(102.41±16.98)和(109.15±20.86)ng/(h·ml).缓释胶囊相对于普通片的生物利用度为93.82%.达稳态后,FI分别为(0.524±0.205),(0.637±0.159).结论:缓释胶囊波动指数较小、吸收好、给药方便.
AIM:To study the pharmacokinetics and relative bioavailability of a sustained-release formulation of albuterol. METHODS: Albuterol was determined following a single and multiple oral dose given to volunteers in an open randomized crossover study. RESULTS: After a single oral dose the peak levels in plasma averaged(9. 70 ± 2. 94)and (18. 52 ±3. 31)ng/ml at (4. 60±0. 63)and (2. 39±1. 07)h and AUC were (102. 41 ± 16. 98)and (109. 15±20. 86)ng/(h · ml) for sustained-release and conventional formulations respectively. The bioavailability of sustained-release formulation was 93. 82%. The peak-trough fluctuation index (FI) for the two formulations were (0. 524±0. 205)and (0. 637±0. 159) respectively. CONCLUSION: The result showed that two formulations were bioequivalence.
出处
《中国临床药学杂志》
CAS
1998年第1期18-21,共4页
Chinese Journal of Clinical Pharmacy
关键词
沙丁胺醇
生物利用率
HPLL
片剂
缓释胶囊
albuterol
bioequivalence
high performance liquid chromatography
pharmacokinetics
