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目的 :建立检测血清中氯硝西泮 (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 .5 m l样品用 Tris- HCl缓冲液 -乙醚系统萃取净化。色谱条件 :以 C1 8反相柱为分析柱 ,流动相为甲醇 -乙腈 - 0 .0 1%磷酸溶液 (35∶ 15∶ 5 5 V/ V) ,流速 1m l/ m in,柱温 30℃ ,检测波长 2 5 4nm。结果 :CZP在 2 0～ 140 0 ng/ m l范围内呈线性 ,血清中最低检测限 5ng/ m l,绝对回收率 91.8%～ 94.6 %。 9例使用剂量为 0 .0 78～ 0 .36 m g· kg- 1 · d- 1 的癫患儿稳态谷血药浓度为 79.8～ 2 74ng/ m l,症状得到有效控制 ,除嗜睡外未见其他不良反应。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 ;本研究也表明儿科所用的 CZP抗癫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 clonazepam (CZP) in serum and monitor the blood concentration of CZP for clinical application. Method: 0 .5 m l sample was purified by extraction with Tris-HCl buffer-ether system. Chromatographic conditions: a reversed-phase column C1 8 as the analytical column with a mobile phase of methanol-acetonitrile-0.01% phosphoric acid solution (35:15:55 V / V) at a flow rate of 1 ml / , Detection wavelength of 254nm. Results: CZP was linear in the range of 20 ~ 140 0 ng / ml, with the lowest detection limit of 5 ng / ml in serum and the absolute recovery of 91.8% ~ 94.6%. Nine patients with epilepsy at doses of 0.078-0.36 mg · kg-1 · d-1 had a steady-state trough plasma concentration of 79.8-274 ng / ml, and the symptoms were effectively controlled except for lethargy See other adverse reactions. Conclusion: This method is simple, rapid and accurate, suitable for the monitoring of body fluid CZP and pharmacokinetic studies; this study also shows that pediatric CZP anti-epileptic effective plasma concentration range of reliability is worth further study