| 余坤子,程显隆,常艳,孙娴,项新华,麻思宇,陆以云,魏锋,马双成.2022年度中药显微鉴别能力验证项目的结果分析[J].中国药事,2023,(12):1416-1420 |
| 2022年度中药显微鉴别能力验证项目的结果分析 |
| Analysis of Traditional Chinese Medicine Inspection from the Profi ciency Testof the Microscopic Identifi cation of TCM in 2022 |
| 投稿时间：2023-06-02 |
| DOI：doi:10.16153/j.1002-7777.2023.12.011 |
| 中文关键词: 能力验证 中药材 显微鉴别 药品技术监管 |
| 英文关键词: proficiency test Traditional Chinese Medicine microscopic identification drug technologysupervision |
| 基金项目: |
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| 中文摘要: |
| 目的：通过考察药品检验检测机构使用显微技术进行中药检验的能力，寻找存在的问题，提升药品检验检测机构的检测水平，确保药品检验检测质量。方法：采用随机单盲方式分配4组测试样品至参加的实验室。样品的检定结果与指定值一致的，结果为满意；再对所有结果进行汇总分析。结果与结论：全国报名单位有225家，7家退出，有效参加单位为218家。共得到872个结果，其中满意结果852个，占97.71%。各参加单位的结果及原始记录显示，显微制片水平、显微基础知识储备以及显微判别原则是影响检测结果的重要因素。在此基础上，提出改进对策和整改措施，为各检验机构提高中药显微鉴别能力提供依据。 |
| 英文摘要: |
| Objective: To identify existing problems by evaluating the ability of the drug inspection and testinginstitutions to use microscopic technology for Traditional Chinese Medicine (TCM) inspection, so as to improvethe testing level of the drug inspection and testing institutions and ensure the quality of drug inspection andtesting. Methods: Four groups of test samples were randomly and single blindly distributed to participatinglaboratories. The result was satisfactory when the testing result was according with the nature of the sample(genuine and counterfeit). All the results were subsequently summarized and analyzed. Results and Conclusion:A total of 225 laboratories applied for this profi ciency test, seven laboratories were withdrawn, and there were218 valid participated laboratories obtaining 872 results. Among which, a total of 852 results were satisfied,accounting for 97.71%. The results and records from participating laboratories indicated that the capability ofmicroscopic preparation, reserving basic knowledge of microscopic and clarifying the principle of discriminatingmicroscopic results are key factors to infl uence the inspection. In the view of above aspects, this article proposescountermeasures and suggestions to provide a basis for each inspection institution, and to improve the capabilityof TCM microscopic identifi cation. |
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