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| 治疗药物浓度监测用质控物的制备及其质控方法的应用 | |
| 引用本文： | 崔练,刘鹥雯,何怡青,杨思,杨翠霞,高锋. 治疗药物浓度监测用质控物的制备及其质控方法的应用[J]. 检验医学, 2008, 23(1): 72-75 |
| 作者姓名： | 崔练 刘鹥雯 何怡青 杨思 杨翠霞 高锋 |
| 作者单位： | 上海交通大学附属第六人民医院实验中心,上海,200233;上海交通大学附属第六人民医院实验中心,上海,200233;上海交通大学附属第六人民医院实验中心,上海,200233;上海交通大学附属第六人民医院实验中心,上海,200233;上海交通大学附属第六人民医院实验中心,上海,200233;上海交通大学附属第六人民医院实验中心,上海,200233 |
| 摘 要： | 目的自行制备室内质控物，用于检测治疗药物监测（TDM）系统的内部质量控制。方法将适量的甲氨喋呤标准品加入正常人体检的血清中配制成所需浓度，置-80℃保存。采用反相高效液相色谱法（RP-HPLC）测定其浓度。结果经过长期观察测定，其测定均值在1年内的差异无统计学意义（在靶值的±15％允许误差范围内）。结论自行制备的室内质控物具有良好的稳定性，可满足室内质控的要求。 |
| 关 键 词： | 质控品 治疗药物监测 稳定性 室内质量控制 即刻法 |
| 文章编号： | 1673-8640（2008）01-0072-04 |
| 收稿时间： | 2007-05-21 |
| 修稿时间： | 2007-05-21 |
Preparation of quality control sera for therapeutic drug monitoring and its application in clinical laboratory |
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| CUI Lian,LIU Yiwen,HE Yiqing,YANG Si,YANG Cuixia,GAO Feng. Preparation of quality control sera for therapeutic drug monitoring and its application in clinical laboratory[J]. Laboratory Medicine, 2008, 23(1): 72-75 | |
| Authors: | CUI Lian LIU Yiwen HE Yiqing YANG Si YANG Cuixia GAO Feng |
| Affiliation: | . ( Central Laboratory, the Sixth People＇s Hospital, Shanghai Jiaotong University, Shanghai 200233, China) |
| Abstract: | Objective To prepare self made quality control sera for monitoring therapeutic drug （TDM） assay in internal quality control process. Methods The required amount of methotrexate solution was dissolved in the normal human sera. The final concentration was adjusted to our need, and then stored at - 80 ℃ until use. The level of methotrexate was determined by reverse phase high performance liquid chromatography （ RP-HPLC ）. Results After a long term study, the results indicated that the mean values had no significant deference in one year （ mean value within ± 15% ）. Conclusions The self made quality control sera is quite stable and could be used in internal quality control programme. |
| Keywords: | Quality control serum Therapeutic drug monitoring Stability Internal quality control Instant methods |
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