HPLC测定抗癫痫“中药”中四种西药成分血药浓度

Determination of blood drug levels of four chemical components of anti-epileptic Traditional Chinese Medicines by HPLC

目的：采用高效液相色谱法同时测定抗癫痫＂中药＂中四种西药成分苯巴比妥、卡马西平、苯妥英和安定血药浓度,以指导临床安全、有效、合理用药。方法：应用高效液相色谱法,采用Symmtry C18色谱柱,磷酸盐缓冲液-乙腈（64∶36）为流动相,紫外检测波长214 nm。微量血中乙腈沉淀蛋白,上清液进样分析。结果：苯巴比妥、卡马西平、苯妥英和安定色谱分离理想,分别在5.0~50.0、1.0~12.0、5.0~25.0和0.10~2.00 mg/L范围内线性关系良好,日内和日间精密度〈5%,平均相对回收率为98.65%~102.64%。结论：本方法简便、快速、精密、准确,用血量少,适用于临床治疗药物监测,为临床用药的合理、有效、安全提供保证。

Objective： To simultaneously determine the blood drug levels of four chemical components,phenobarbital,carbamazepine,diphenylhydantoin and diazepam,of anti-epileptic traditional Chinese medicine preparations by high-performance liquid chromatography（HPLC）,so as to realize rational utilization of the medicine.Methods： Symmtry C18 column was employed as stationary phase and the solution of phosphate buffer and acetonitrile（64∶36） as mobile phase.The was detected at the wavelength of 214 nm.The protein in blood was precipitated with acetonitrile.Results： Phenobarbital,carbamazepine,diphenylhydantoin and diazepam were well separated and showed ideal linear correlation in the range of 5.0～50.0,1.0～12.0,5.0～25.0 and 0.10～2.00 mg/L respectively.The differences of precision within a day and between days were lower than 5%.The average relative recovery was between 98.65% and 102.64%.Conclusion： This approach is convenient,rapid,sensitive,precise and accurate,being suitable for therapeutic drug monitoring（TDM） and guiding clinical rational use of the drug.