高效液相色谱法同时测定人血浆中奥氮平、氯丙嗪的浓度及其在精神病患者中的应用

Simultaneous Determination of Olanzapine and Chlorpromazine in the Plasma of Patients with Schizophrenia by Ultra Performance Liquid Chromatography and its Application in Psychotic

使用奥氮平和氯丙嗪对不同年龄、不同性别的精神分裂患者进行临床研究,并建立同时测定人血浆中奥氮平和氯丙嗪的高效液相色谱法。630病例分为对照组、奥氮平片组、氯丙嗪片组和联合组,分别进行持续6个星期的给药观察;血浆中测定以Chromolith High Resolution C_(18)(100 mm×4.6 mm,5.0μm),柱温35℃,流动相为20 mmol/mL磷酸盐缓冲液(pH 3.14)和乙腈,梯度洗脱,体积流量为0.8 mL/min,检测波长为225 nm。联合组有效率显著大于对照组,P<0.05差异有统计学意义;奥氮平和氯丙嗪的质量浓度分别在0.125~50.0μg/mL和0.200~50.0μg/mL范围内与峰面积线性关系良好,定量限分别为0.069μg/mL和0.093μg/mL,回收率分别在99%~102%和95%~103%之间,RSD均低于2%。该方法简单便捷,可用于精神分裂症患者体内奥氮平和氯丙嗪血药浓度的测定。奥氮平和氯丙嗪联合使用对不同年龄、不同性别的精神分裂患者具有临床效果。

To use olanzapine and chlorpromazine to conduct clinical research on schizophrenia patients of different ages and genders,and establish a HPLC method for determining the concentration of olanzapine and chlorpromazine in human plasma,630 cases were divided into the control group,olanzapine tablets group,chlorpromazine tablets group and the combined group,and they were administered and observed for 6 weeks respectively;the measurement in plasma was chromolith high resolution C_(18)(100 mm×4.6 mm,5.0μm),the column temperature was 35℃,and the mobile phase was 20 mmol/mL phosphate buffer(pH 3.14)and acetonitrile,gradient elution,flow rate of 0.8 mL/min,detection wavelength of 225 nm.The effective rate of the observation group was significantly higher than that of the control group,P<0.05,the difference was statistically significant;the linear relationship of olanzapine and chlorpromazine with the peak area were 0.125~50.0μg/mL and 0.200~50.0μg/mL,respectively.The limit of quantification were 0.069μg/mL and 0.093μg/mL,and the recovery rate were 99%~102% and 95%~103%.In between,the RSDs were less than 2%.This method is simple and fast.It is suitable for the determination of olanzapine and chlorpromazine in patients with schizophrenia.Olanzapine and chlorpromazine has clinical effects on schizophrenia patients of different ages and genders.