高效液相色谱/质谱法测定人血清中地氯雷他定及其药代动力学研究
[Study on determination of desloratadine in human serum and its pharmacokinetics by HPLC/MS].
作者信息
Lu Xiao-yang, Sheng-Tu Jian-zhong, Chen Zhi-gen, Huang Ming-zhu, Zhou Hui-li, Zheng Guo-gang
机构信息
Department of Clinical Pharmacology, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou 310003, China.
出版信息
Zhejiang Da Xue Xue Bao Yi Xue Ban. 2005 Jul;34(4):372-4. doi: 10.3785/j.issn.1008-9292.2005.04.019.
OBJECTIVE
To study the determination of desloratadine in human serum and its pharmacokinetics in healthy volunteers.
METHODS
A single oral dose of 10 mg desloratadine was given to 18 healthy volunteers. The serum concentrations of desloratadine were determined by HPLC-MS assay. The pharmacokinetics parameters of desloratadine tablets were calculated with program 3P97.
RESULT
The main pharmacokinetics parameters of desloratadine tablets were as followsút(max)(1.611 +/-0.366)h, C(max) (4.455+/-1.990)microg x L(-1), AUC(0-t) (58.50+/-21.34)microg x L(-1) x h(-1), AUC(0-infinity) (60.59+/-22.32)microg x L(-1) x h(-1), t(1/2(ke)) (20.303+/-5.833)h, Ke (0.0372+/-0.0116)h(-1) and CL(0.1838+/-0.0563)L x h(-1).
CONCLUSION
Desloratadine tablet is absorbed quicker in the 18 healthy volunteers than the reports and its peak blood concentration reached at 1.5 h after oral administration with t(1/2) 20 h.
目的
研究地氯雷他定在人血清中的测定方法及其在健康志愿者体内的药代动力学。
方法
给18名健康志愿者单次口服10mg地氯雷他定。采用高效液相色谱-质谱联用法测定血清中地氯雷他定的浓度。用地氯雷他定片的药代动力学参数用3P97程序计算。
结果
地氯雷他定片的主要药代动力学参数如下：t(max)(1.611±0.366)小时，C(max)(4.455±1.990)μg·L(-1)，AUC(0-t)(58.50±21.34)μg·L(-1)·h(-1)，AUC(0-∞)(60.59±22.32)μg·L(-1)·h(-1)，t(1/2(ke))(20.303±5.833)小时，Ke(0.0372±0.0116)h(-1)，CL(0.1838±0.0563)L·h(-1)。
结论
地氯雷他定片在18名健康志愿者体内吸收较文献报道更快，口服给药后1.5小时达到血药浓度峰值，t(1/2)为20小时。
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