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目的 建立检测血清中氯硝西伴(clomazepam,CZP)的高效液相色谱法,监测CZP血药浓度,为临床应用提供依据.方法0.5ml样品用Tris－HCI缓冲液-乙醚系统萃取净化.色谱条件;以C_(18)反相柱为分析柱,流动相为甲醇-乙睛-0.01%磷酸溶液(35:15:50V/V),流速1ml/min,柱温30℃,检测波长254mm.结果CZP在20-1400ng/ml范围内呈线性,血清中最低检测限5ng/ml,绝对回收率91.8-94.2%.9例使用剂量为0.078-0.36mg/(kg·d)的癫痛患儿稳态谷血药浓度在79.8－274nl/mg之间,症状得到有效控制,除困倦和嗜睡外未见其它副作用.结论 本法简便、快速、准确,适合于体液中CZP的监测及药物动力学研究;本研究也提示儿科所用的CZP抗癫病有效血药浓度范围的可靠性值得进一步探讨.
OBJECTIVE To establish a HPLC method for the determination of clozapine (CZP) in serum and monitor the blood concentration of CZP for clinical application.METHODS 0.5ml samples were purified by extraction with Tris-HCI buffer-ether system. The mobile phase consisted of methanol - acetonitrile - 0.01% phosphoric acid solution (35:15:50 V / V), the flow rate was 1 ml / min, the column temperature was 30 ℃ and the detection wavelength was 254 mm. Results CZP was linear in the range of 20-1400ng / ml with the detection limit of 5ng / ml and the absolute recovery of 91.8-94.2% .9 children with epilepsy were used at the dosage of 0.078-0.36mg / (kg · d) The steady-state trough plasma concentration was between 79.8-274nl / mg, the symptoms were effectively controlled, and no other side effects were found except drowsiness and drowsiness Conclusion This method is simple, rapid and accurate and suitable for the monitoring of body fluid CZP and pharmacokinetics This study also suggests that the reliability of pediatric CZP anti-epilepsy effective plasma concentration range worth further study.