GC法监测丙戊酸血药浓度的室内质控评估  

Evaluation of Blood Monitoring Method for Valproic Acid by Gas Chromatogaphy

作　　者：黄琪[1] 周伯庭[1] 马虹英[1] 刘琼[2] 

机构地区：[1]中南大学湘雅医院药学部,湖南长沙410008 [2]中南大学湘雅医院肿瘤科,湖南长沙410078

出　　处：《解放军药学学报》2017年第3期233-236,共4页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的评价GC法在丙戊酸血药浓度监测中的稳定性,建立并改善丙戊酸血药浓度监测的质量控制方法。方法通过SPSS18.0软件对2015年9月—10月随行质控样本的高、中、低3个浓度水平的测定值做回顾性研究,并进行统计学分析,绘制Levey-Jennings质控图和Z-分数质控图,分析警告和失控原因,制定合适的质控规则。结果丙戊酸低、中、高浓度(22.16、80.62、160.15μg·ml^(-1))室内质控的日内和日间RSD分别为2.2%~4.3%、3.6%~7.1%,回收率分别为97.92%~99.06%、99.48%~101.08%,符合《中国药典》2010年版(二部)生物样品测定的要求。质控样本的低、中、高浓度的随行质控RSD分别为5.36%、4.94%、2.56%,适合本实验室的质控规则为12、13、22、41s及7x。结论影响GC法监测丙戊酸血药浓度的质量控制的因素较多,利用室内质控评价体系对检测数据进行评估,在日常血药浓度监测过程中确保治疗药物监测数据准确、可靠,为临床调整剂量提供准确信息。Objective To evaluate the stability of gas chromatogaphy （GC） in the therapeutic drug monitoring （TDM） of valproic acid, to establish and improve quality control methods for plasma concen- tration monitoring of valproic acid.Methods The results of plasma concentration monitoring of high, middle and low concentrations of control samples between September and October 2015 were retrospectively stud- ied and statistically analyzed by SPSS18.0 software, a Levey-Jennings control chart and Z-score control chart were drawn, reasons for warnings and cack of control were analyzed, and effective quality control rules were made.Results Intra-day and inter-day RSD of low, middle and high concentrations （22.16, 80.62, 160.15 μg·ml^-1） of valproic acid ranged from 2.2% to 4.3% and from 3.6% to 7.1~/~o,respectively, while the recovery rates ranged from 97.92% to 99.06% and from 99.48% to 101.08% ,respectively.This met the requirements of biological sample determination in Chinese Pharmacopoeia. The RSD of low, middle and high concentrations of control samples was 5.36 %, 4.94% and 2.56%, respectively. The quality control rules were 12s, 13s, 22s, 41s and 7x.Conclusion This GC method is simple,user-friendly and easy to man- age for internal quality control of clinical plasma concentration monitoring of valproic acid.

关 键 词：室内质控 GC 治疗药物浓度监测 Levey-Jennings质控图 Z-分数质控图 

分 类 号：R927.1[医药卫生—药学] R97