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目的 建立测定人血浆中奥氮平浓度的HPLC-UV方法,研究健康受试者口服奥氮平片后的药代动力学。方法 以阿米替林为内标,血浆样品加维生素C抗氧化,经碱化后用乙醚-环已烷进行萃取。以0.01mol/L磷酸铵（pH4.0）-甲醇-乙腈（55:22.5:22.5）为流动相,采用Hypersil silica柱进行分离,紫外270nm处进行测定。结果 方法的专属性较好;低、中、高浓度（1.19,9.50,38.00ng/ml）的平均提取回收率分别为81.97,93.47和96.72。该法在1.19～38.00 ng/ml浓度范围内呈线性关系,最低检测浓度为1.19ng/ml,日内、日间RSD分别小于9％和12％。用此法测定了20名健康受试者单剂量po奥氮平片后的血药浓度经时变化过程。结论 该法灵敏度高,重现性好,操作简便,适用于临床药代动力学研究和血药浓度监测。
OBJECTIVE To establish a HPLC-UV method for the determination of olanzapine in human plasma and study the pharmacokinetics of oral olanzapine tablets in healthy subjects. Methods Amitriptyline was used as internal standard. Plasma samples were supplemented with vitamin C and alkalized and extracted with ether-cyclohexane. The separation was performed on a Hypersil silica column with 0.01 mol / L ammonium phosphate (pH 4.0) - methanol - acetonitrile (55: 22.5: 22.5) as the mobile phase. The results showed that the specificity of the method was better. The average recoveries of low, medium and high concentrations (1.19,9.50,38.00ng / ml) were 81.97, 93.47 and 96.72, respectively. The method was linear in the range of 1.19-38.00 ng / ml with the lowest detection concentration of 1.19 ng / ml. The intra-day and inter-day RSD were less than 9% and 12%, respectively. Using this method, the changes of the plasma concentration of 20 healthy subjects after a single oral dose of olanzapine tablets were determined. Conclusion The method has high sensitivity, good reproducibility, simple operation, suitable for clinical pharmacokinetic studies and plasma concentration monitoring.