摘要
１０名男性健康志愿者随机、交叉、单剂量口服 １０ｍｇ国产和进口酒石酸唑吡坦制剂，采用ＨＰＬＣ－荧光检测法测定血浆药物浓度，激发波长为２５４ｎｍ，发射波长为３９０ｎｍ。药时曲线符合一室开放模型，国产药品和进口药品的Ｃ_（ｍａｘ）为１２１．３６± ２７．３８ μ ｇ· Ｌ^（－１）和 １２４．４０ ± ４１２２ １１９· Ｌ^（－１）； Ｔ为 １．５２ ± １．１０ ｈ和 １４０ ±１．０２ｈ；ＡＵＣ_（０－ｔ）；为 ４９５．６２±２１２．９０ ｈ· μ ｇ·Ｌ^（－１）和 ４６７．２９。 １４６．２６ｈ·μｇ·Ｌ^（－１）。 ＡＵＣ_（ｏ－ｔ）和Ｃ_（ｍａｘ）及对数转换后经三因素方差分析和双向单侧ｔ检验，均无显著性差异，试验药品和对照药品具有生物等效性，试验药品的相对生物利用度为１０３．５９％±１８．６０％。
A single 10mg oral dose of domestic and imported zolpidem tartrate tablet were given to 10 healthy volunteers in randomized crossover study .A high performance liquid chromatographic assay with fluorimetric detection was developed for determining the concentration of zolpidem in human plasma,the excitation and emission wavelengths were 254nm and 390nm.One open compartment model was fitted to the concentration time curve.The pharmacokinetic parameters of domestic and imported preparations were as follows: C_(max) 121 .36 ± 27.38 μg· L^(-1), 124.40 ± 41 .22 μg ·L^(-1); Tab 1.52 ± １.10h,1.40 ± 1.02h; AUC_(0-t)495.62 ± 212.90 h·μ gL^(-1), 467.29 ± 146.26h' p g· L^(-1).Variance analysis and two one-sided test were performed to AUCo-,, Cmax, InAUC_(o=t),InC_(max).There were no significance.The two preparations were of bioequivalence,the relative bioavailability was 103.59% 1 18.60%.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2000年第2期122-124,共3页
The Chinese Journal of Clinical Pharmacology
