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高效液相色谱法测定血清中依普黄酮及其在健康志愿者体内的药代动力学研究

[High performance liquid chromatographic method for the determination of ipriflavone in serum and its pharmacokinetic study in healthy volunteers].

作者信息

Ma X H, Xu Y, Liu T P

机构信息

Department of Pharmacology, Nanjing Medical University, Nanjing 210029.

出版信息

Yao Xue Xue Bao. 1997 Jun;32(6):470-2.

Abstract

A sensitive and rapid high performance liquid chromatographic method has been developed for the determination of ipriflavone in human serum. The average recovery of ipriflavone was 85% with relative standard deviation of 3.8%-5.4%. The calibration curve was linear in the range from 8 ng.ml-1 to 400 ng.ml-1 with gamma = 0.9981. The detection limit of the method was 3 ng.ml-1 (S/N > or = 3). The serum drug concentration-time curve exhibited a 2-compartment model and the mean T1/2 beta was 12.00 +/- 1.89 h (for ipriflavone made in Japan) and 9.05 +/- 0.80 h (for ipriflavone made in China). The AUC0-->infinity of the two kinds of ipriflavone were 804.99 ng.h.ml-1 and 807.40 ng.h.ml-1, respectively. The relative bioavailability of ipriflavone made in China vs that made in Japan was 1.003.

摘要

已开发出一种灵敏、快速的高效液相色谱法用于测定人血清中的依普黄酮。依普黄酮的平均回收率为85%,相对标准偏差为3.8%-5.4%。校准曲线在8 ng.ml-1至400 ng.ml-1范围内呈线性,γ = 0.9981。该方法的检测限为3 ng.ml-1(信噪比≥3)。血清药物浓度-时间曲线呈现二室模型,平均T1/2β为12.00±1.89小时(日本产依普黄酮)和9.05±0.80小时(中国产依普黄酮)。两种依普黄酮的AUC0→∞分别为804.99 ng.h.ml-1和807.40 ng.h.ml-1。中国产依普黄酮相对于日本产依普黄酮的相对生物利用度为1.003。

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