摘要
目的：本文对布洛芬缓释片和胶囊在健康志愿者中的药物动力学进行研究。方法：建立了一个测定人血中布洛芬的高效液相色谱法。结果：口服单剂量６００ｍｇ片剂和胶囊的ＡＵＣ分别为１５０．２±３４．８和１５１．８±３４．５μｇ·ｈ·ｍｌ－１；Ｃｍａｘ分别为２２．７±５．３和２２．２±３．９μｇ·ｍｌ－１；Ｔｍａｘ分别为３．５±０．７和３．８±０．８ｈ。口服多剂量６００ｍｇ达稳态后片剂和胶囊的ＡＵＣ分别为１５６．０±３８．７和１６３．２±４４．７μｇ·ｈ·ｍｌ－１；Ｃｍａｘ分别为２４．６±５．５和２３．８±４．４μｇ·ｍｌ－１；Ｔｍａｘ分别为３．０２±０．２９和３．２±０．５ｈ。达稳态后片剂和胶囊的波动系数分别为１．４±０．３和１．４２±０．２３。经统计学处理，上述各参数间差异均无显著性（Ｐ＞０．０５）。结论：双单侧ｔ检验（ＮＤＳＴ程序）的结果表明，布洛芬两种缓释制剂具有生物等效性。
randomized crossover study in 10 volunteers was conducted to compare pharmacokinetics of the two sustained release preparations of ibuprofen.The results of single dose tablets and capsules showed that AUC were 150.2±34.8 and 151.8±34.5 μg·h·ml-1;Cmax were 22.7±5.3 and 22.2±4.0 μg·ml-1;Tmax were 3.5±0.7 and 3.8±0.8 h respectively.The result of continous administration of the two ibuprofen preparations indicated that AUC were 156.0±38.7 and 163.2±44.7 μg·h·ml-1;Cmax were 24.6±5.5 and 23.8±4.4 μg·ml-1;Tmax were 3.02±0.29 and 3.15±0.50 h respectively.The FI of tablets and capsules were 1.43±0.32 and 1.42±0.23 at steady state.There were no significant differences in all pharmacokinetic parameters between the tablets and capsules of ibuprofen (P>0.05).The teat of bioequivalent in the two preparations is the same.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
1998年第7期291-293,共3页
Chinese Journal of Hospital Pharmacy
