HPLC法同时测定血中拉莫三嗪、奥卡西平活性代谢物药物浓度及其在儿童癫痫中的应用  

An HPLC Method for Simultaneous Determination of Plasma Concentration of Lamotrigine and Oxcarbazepine Active Metabolite and Its Application in Children with Epilepsy

作　　者：林志燕[1] 刘海涛[1] 舒扬[1] 王芳[1] 田怀平[1] 徐阿晶[1] 

机构地区：[1]上海交通大学医学院附属新华医院,上海200092

出　　处：《儿科药学杂志》2013年第2期4-7,共4页Journal of Pediatric Pharmacy

摘　　要：目的:建立同时测定人血清中拉莫三嗪(LTG)和奥卡西平活性代谢物10-羟基卡马西平(MHD)浓度的HPLC方法,并将该方法应用于临床癫痫患儿血药浓度监测。方法:采用甲醇提取血清中LTG和MHD进样测定。色谱柱为Inertsil ODS-3柱(4.6mm×250mm,5μm);流动相为甲醇-水(45∶55);流速1.0mL/min;柱温25℃;检测波长225nm。结果:LTG在0.8～40.0μg/mL浓度范围内线性关系良好(r=0.999 9),MHD在0.56～56.00μg/mL浓度范围内线性关系良好(r=0.999 9);LTG高、中、低浓度的平均回收率分别为(99.68±4.29)%、(98.21±3.14)%、(97.78±2.52)%,MHD高、中、低浓度的平均回收率分别为(103.40±4.13)%、(102.30±2.88)%、(99.77±2.25)%;日内、日间精密度RSD均小于5%。结论:该方法灵敏度高,选择性强,快速、简便、准确,适用于临床标本的检测和药物代谢动力学研究,并可为临床合理用药提供依据。Objective： To establish an high-performance liquid chromatography （HPLC） method to assay the concentration of lanmtrigine and oxcarbazepine active metabolite （ MIlD ） in human serum simultaneously and to apply this method in clinical plasma concentration monitoring in epilepsy children. Methods： Methanol was used to extract the concentration of lamotrigine and MHD from serum. The （HPLC） method was performed on the column of Inertsil ODS-3 column（4.6 mm^250 ram, 5 μm） ; the mobile phase consisted of methanol-H20 （45 ： 55）; the flow rate was set at 1.0 mL/min; the column was kept at 25 ℃; and the UV detection wavelength was 225 nm. Results： The calibration curve had a good linearity when the Lamotrigine was within a concentration range of 0.8 ± 40μg/mL （ r = 0. 9999 ）. The calibration curve had a good linearity when the MHD was within a concentration range of 0.56- 56 μg/mL （r=0. 9999）. The average rates of lamotrigine in high, medium and low concentrations were （99.68±4.29）%, （98.21 ±3. 14）% and （97.78±2.52）%, respectively. The average rates of MHD in high, medium and low concentrations were （ 103.40±4.13 ） %, （102.30±2.88） % and （99.77±2.25） %, respectively. The inter-day and intra-day relative standard deviations were less than 5% （n=5）. Conclusions： The method was shown to be sensitive, selective, accurate, handy and speedy. It may be used in clinical specimen testing and pharmacokinetie studies, and may be helpful for rational drug use.

关 键 词：拉莫三嗪 奥卡西平 10-羟基卡马西平 血药浓度 癫痫 儿童 

分 类 号：R969.3[医药卫生—药理学]