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目的:分析丙戊酸钠血药浓度测定衍生时的影响因素,保证临床测定的准确性。方法:丙戊酸钠血药浓度用高效液相色谱(HPLC)法测定。血浆样品用2-溴-对硝基苯乙酮为衍生试剂,以丙戊酸钠衍生物产率为指标,用单因素考察法考察衍生试剂浓度、三乙胺体积分数、反应温度、反应时间对丙戊酸钠衍生产率的影响。结果:衍生试剂2-溴-对硝基苯乙酮浓度为1.5~2.0mg·mL~(-1),催化剂三乙胺体积分数为20%,衍生温度和衍生时间分别为60℃,10 min时,丙戊酸衍生完全,血药浓度在10~200μg·mL~(-1)范围内,线性较好(R~2=0.999 5),回收率为95.00%~100.59%,日内与日间RSD≤5%,符合《中国药典》中对生物样本药物浓度检测的规定。结论:影响丙戊酸血药浓度测定的因素较多,如衍生试剂浓度和三乙胺体积分数、衍生时间、衍生温度等。在日常血药浓度监测过程中,我们应注意这些差异,尽量将误差控制在允许范围之内,保证丙戊酸钠治疗药物监测结果的准确性。
Objective: To analyze the influencing factors of determination of plasma concentration of valproate in order to ensure the accuracy of clinical determination. Methods: The plasma concentration of sodium valproate was determined by high performance liquid chromatography (HPLC). Plasma samples were treated with 2-bromo-p-nitroacetophenone as the derivatization reagent and the yield of sodium valproate as an index. The concentration of the derivatizing reagent, the volume fraction of triethylamine, the reaction temperature and the reaction time Effect of sodium valproate on yield. Results: The concentration of 2-bromo-p-nitroacetophenone was 1.5-2.0 mg · mL -1, the volume fraction of triethylamine was 20%, the derivatization temperature and derivatization time were 60 ℃ and 10 min respectively When valproic acid was completely derivatized, the linearity was good (R ~ 2 = 0.999 5) and the recoveries ranged from 95.00% to 100.59% at the range of 10 ~ 200μg · mL -1 RSD ≤ 5%, in line with the “Chinese Pharmacopoeia” in the biological sample drug concentration testing requirements. Conclusion: There are many factors affecting the determination of plasma concentration of valproic acid, such as the concentration of derivatization reagent and volume fraction of triethylamine, derivatization time, derivatization temperature and so on. In the daily blood concentration monitoring process, we should pay attention to these differences, try to control the error within the allowable range, to ensure the accuracy of sodium valproate drug monitoring results.