HPLC法和FPIA法检测卡马西平血药体积百分比的比较研究

目的高效液相色谱法(HPLC)和荧光偏振免疫法(FPIA)测定血清中卡马西平体积百分比的比较研究。方法收集广州市精神病医院服用CBZ的21例癫痫患者血样。用本实验室已经建立的HPLC法和FPIA法分别检测卡马西平对照品的甲醇溶液、卡马西平对照品标准血清、患者血清中卡马西平体积百分比,采用配对t检验考察两种方法分别测定卡马西平对照品的甲醇溶液、卡马西平对照品标准血清、患者血清中卡马西平体积百分比有无显著性差异。结果HPLC法与FPIA法检测卡马西平对照品甲醇溶液、卡马西平对照品标准血清中卡马西平体积百分比无显著性差异(t值分别为-1.009、0.767,P值分别为0.325、0.452);检测患者血清中卡马西平血药体积百分比有显著性差异(t=4.919,P<0.05),FPIA法检测患者血清中卡马西平血药体积百分比较HPLC法偏高。结论FPIA法检测患者血清中卡马西平血药体积百分比过程中,CBZ的活性代谢产物环氧化卡马西平(carbamazepine-10,11-epoxide,CBZ-E)可能对FPIA法测定CBZ有干扰,导致结果偏高。

Comparison of HPLC and FPIA Method in Determination of Carbamazepine in Human Serum

Objective To compare High Performance Liquid chromatography (HPLC) and Fluorescence Polarization Immunoassay (FPIA) method in determination of carbamazepine (CBZ) in human serum during routine therapeutic drug monitoring. Methods Twenty-one serum samples were collected from 21 epileptic patients who were taken CBZ in Guangzhou Psychiatric Hospital. Both HPLC and FPIA method were employed to determine the concentration of CBZ in methanol solution, in control serum and in patient serum. The result was analyzed by paired t-test method(using SPSS11.0 statistical software). Results There was no significant difference between results of two methods for methanol sample and control serum (value of t is -1.009, 0.767 respectively, value of P is 0.325, 0.452>0.05, respectively). There was significant difference between results of two methods for patient serum (t=4.919,P<0.05). Conclusions In the determination of carbamazepine in human serum,CBZ-E(carbamazepine-10, 11-epoxide, CBZ-E), active metabolite of carbamazepine, has influenced the CBZ determination by FPIA and cause an apparent high level. The difference of CBZ determination by HPLC and FPIA methods should be paid attention to.