酶放大免疫分析法与二维液相色谱法监测癫痫患者血清中卡马西平浓度的比较(1)
[摘要] 目的 比較酶放大免疫分析法(EMIT)与二维液相色谱法(2D-HPLC)测定卡马西平血药浓度的差异。 方法 采集67例癫痫患者卡马西平血清样本，分别采用EMIT法和2D-HPLC法测定，其中二维液相的色谱条件如下：第一维色谱柱为ASTON-FAQ C8柱(4.0 mm×100.0 mm，3 μm，ANAX)，流动相为乙腈-水(55∶45，v/v)，流速为1 mL/min；中间柱为ASTON C18(4.6 mm×10.0 mm，3 μm，ANAX)；第二维色谱柱为Diamonsil-C18柱(4.6 mm×200.0 mm，5 μm，Dikma)，流动相为乙腈-20 mmol/L乙酸铵(20∶80，v/v，pH=7.0)，流速为1.2 mL/min。柱温为40℃，检测波长为285 nm。结果 两种方法差异无统计学意义，且相关性好，回归方程为y(2D-HPLC)=0.9876×x(EMIT)-0.0313，Bland-Altman分析显示两种方法一致性良好。 结论 EMIT法与2D-HPLC法测定的结果具有良好的一致性和相关性，应综合考虑实验室条件和人员配置等方面，采用合适的测定方法。
[关键词] 卡马西平；血药浓度；酶放大免疫分析法；二维液相色谱法
[中图分类号] R927.2 [文献标识码] A [文章编号] 1673-7210(2018)07(c)-0106-04
Comparison of EMIT and 2D-HPLC in the quantification of Carbamazepine in serum of patients with epilepsy
LIU Hang WANG Min JIN Lu ZHANG Jinping
Department of Pharmacy， the Affiliated Drum Tower Hospital of Nanjing University Medical School， Jiangsu Province， Nanjing 210008， China
[Abstract] Objective To compare the results of Carbamazepine in serum of patients with epilepsy determined by enzyme-multiplied immunoassay technique (EMIT) and two-dimensional liquid phase chromatography(2D-HPLC). Methods The serum concentration of Carbamazepine in 67 epilepsy patients was determined by EMIT and 2D-HPLC， respectively. In 2D-HPLC method， two reversed phase liquid chromatography columns [ASTON-FAQ C8 (4.0 mm×100.0 mm， 3 μm， ANAX) and Diamonsil-C18 (4.6 mm×200.0 mm， 5 μm， Dikma) column] were used as the first and second separation dimensions， respectively. ASTON C18 (4.6 mm×10.0 mm， 3 μm， ANAX) column was used as a connector to transfer the eluent from the first dimensional column to the second column for further separation. The mobile phases of the two dimensions consisted of acetonitrile-H2O (55∶45， v/v) and acetonitrile-20 mmol/L ammonium acetate (20∶80， v/v， pH=7.0)， respectively. The first dimensional column flow rate was 1.0 mL/min， the second dimensional column flow rate was 1.2 mL/min. The detection wavelength was 285 nm， and the column temperature was 40℃. Results There were no significant differences in the serum concentrations of Carbamazepine detected by EMIT and 2D-HPLC. A good correlation was obtained between the two methods. The regression equation was y(2D-HPLC)= 0.9876 × x(EMIT)-0.0313. Bland-Altman plots analysis showed the two methods were consistent. Conclusion Both EMIT and 2D-HPLC methods have good consistency and correlation in the quantification of Carbamazepine. The laboratory conditions and staffing should be taken into consideration when a method is chosen for monitoring the concentration of Carbamazepine., http://www.100md.com(柳航 王敏 金路 张晋萍)
[关键词] 卡马西平；血药浓度；酶放大免疫分析法；二维液相色谱法
[中图分类号] R927.2 [文献标识码] A [文章编号] 1673-7210(2018)07(c)-0106-04
Comparison of EMIT and 2D-HPLC in the quantification of Carbamazepine in serum of patients with epilepsy
LIU Hang WANG Min JIN Lu ZHANG Jinping
Department of Pharmacy， the Affiliated Drum Tower Hospital of Nanjing University Medical School， Jiangsu Province， Nanjing 210008， China
[Abstract] Objective To compare the results of Carbamazepine in serum of patients with epilepsy determined by enzyme-multiplied immunoassay technique (EMIT) and two-dimensional liquid phase chromatography(2D-HPLC). Methods The serum concentration of Carbamazepine in 67 epilepsy patients was determined by EMIT and 2D-HPLC， respectively. In 2D-HPLC method， two reversed phase liquid chromatography columns [ASTON-FAQ C8 (4.0 mm×100.0 mm， 3 μm， ANAX) and Diamonsil-C18 (4.6 mm×200.0 mm， 5 μm， Dikma) column] were used as the first and second separation dimensions， respectively. ASTON C18 (4.6 mm×10.0 mm， 3 μm， ANAX) column was used as a connector to transfer the eluent from the first dimensional column to the second column for further separation. The mobile phases of the two dimensions consisted of acetonitrile-H2O (55∶45， v/v) and acetonitrile-20 mmol/L ammonium acetate (20∶80， v/v， pH=7.0)， respectively. The first dimensional column flow rate was 1.0 mL/min， the second dimensional column flow rate was 1.2 mL/min. The detection wavelength was 285 nm， and the column temperature was 40℃. Results There were no significant differences in the serum concentrations of Carbamazepine detected by EMIT and 2D-HPLC. A good correlation was obtained between the two methods. The regression equation was y(2D-HPLC)= 0.9876 × x(EMIT)-0.0313. Bland-Altman plots analysis showed the two methods were consistent. Conclusion Both EMIT and 2D-HPLC methods have good consistency and correlation in the quantification of Carbamazepine. The laboratory conditions and staffing should be taken into consideration when a method is chosen for monitoring the concentration of Carbamazepine., http://www.100md.com(柳航 王敏 金路 张晋萍)