| 贝琦华,李祎,刘逸韬,赵萌,严全鸿,项新华.电位滴定法测定尼美舒利含量能力验证结果分析[J].中国药事,2019,33(3):290-294 |
| 电位滴定法测定尼美舒利含量能力验证结果分析 |
| Analysis of the Proficiency Testing Results of the Determination of Nimesulide by Potentiometric Titration |
| 投稿时间：2018-12-20 |
| DOI：10.16153/j.1002-7777.2019.03.009 |
| 中文关键词: 能力验证 电位滴定 尼美舒利 |
| 英文关键词: proficiency testing potentiometric titration nimesulide |
| 基金项目: |
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| 摘要点击次数: 1628 |
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| 中文摘要: |
| 目的：设计组织尼美舒利含量测定的能力验证项目（编号NIFDC-PT093），评价药品检测机构电位滴定法的测定能力。方法：对参加实验室的测定结果进行稳健统计分析，用Z比分数评价实验室检测能力。结果：共153家实验室反馈了结果，其中33个参加实验室（占21.6%）的结果可疑或不满意。省级以上食品药品检验机构的满意率（占92.6%）高于其他机构。结论：本次能力验证项目检测结果主要受滴定液、电极、电位滴定仪、空白试验和溶剂的影响，建议离群者可采取调整滴定液浓度、选择合适电极和滴定参数等措施以保证结果的准确。 |
| 英文摘要: |
| Objective:To design and organize the proficiency testing (PT) project to determine the content of nimesulide (No. NIFDC-PT093) in order to assess the proficiency of potentiometric titration in the drug control laboratories. Methods:Results of participant laboratories were analyzed by the Robust Statistical method and the proficiency of the participant laboratories was evaluated by Z-Score. Results:A total of 153 laboratories reported their results. 33 participant laboratories (21.6%) presented suspicious or unsatisfactory results. The satisfactory rate of the food and drug control laboratories at the provincial or above level (92.6%) was higher than that of other laboratories. Conclusion:The results of this PT project are mainly affected by titration solution, electrodes, potentiometric titrator, blank test and solvent. It is recommended that outliers adjust the concentration of titration solution, select appropriate electrodes and titration parameters, etc. to get accurate results. |
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