摘要
目的：比较盐酸氨溴索口服溶液和片剂的生物利用度与药代动力学。方法：志愿者随机交叉单剂量口服９０ｍｇ盐酸氨溴索口服溶液和片剂，ＨＰＬＣ法测定血浆中的药物浓度，采用三因素方差分析和双向单侧ｔ检验比较两种制剂的ＡＵＣ。结果：口服溶液和片剂的ｃｍａｘ分别为（１６９．０３±２３．４２）和（１６３．１７±２３．４１）ｎｇ／ｍｌ；ｔｍａｘ分别为（１．２０±０．２２）和（１．４４±０．２３）ｈ；ｔ１／２β分别为（７．０７±１．５４）和（７．９７±１．１７）ｈ；ＡＵＣ分别为（１２８７．１３±２５０．８４）和（１３１７．８５±１５１．３１）ｈ·ｎｇ／ｍｌ。结论：盐酸氨溴索口服溶液与片剂具有相同的生物利用度，口服溶液的相对生物利用度为（９７．６１±１５．６５）％。
Objective: Methods: Volunteers were given oral solution or tablet with a single oral dose of 90 mg ambroxol hydrochloride in a randomized crossover study. The plasma concentrations of ambroxol were determined by HPLC method. Three factors analysis of variance and two one side t test were adopted in the evaluation of the area under plasma drug concentrations time curve (AUC ). Results: The maximum plasma concentration( c max ) of ambroxol oral solution and tablet were(169.03±23.42) and (163.17 ± 23.41) ng/ml; the time to reach c max (t max ) were (1.20±0.22) and (1.44±0.23) h; elimination half life(t 1/2β ) were(7.07±1.54) and (7.97 ± 1.17) h, AUC were (1 287.13±250.84) and (1 317.85 ± 151 31) h·ng/ml, respectively. Conclusion: The two preparations of ambroxol are of the same bioavailability. The relative bioavailability of oral solution of ambroxol is (97.61±15.65)%.
出处
《第二军医大学学报》
CAS
CSCD
北大核心
1999年第1期30-32,共3页
Academic Journal of Second Military Medical University
关键词
盐酸氨溴索
生物利用度
药物动力学
ambroxol hydrochloride
bioavailability
pharmacokinetics
HPLC
