| 六味安消胶囊含量测定的能力验证研究 |
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| 引用本文： | 何风艳,王明娟,胡晓茹,刘静,赵萌,项新华,戴忠,马双成.六味安消胶囊含量测定的能力验证研究[J].中国药事,2018,32(8):1120-1124. |
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| 作者姓名： | 何风艳 王明娟 胡晓茹 刘静 赵萌 项新华 戴忠 马双成 |
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| 作者单位： | 中国食品药品检定研究院, 北京 100050,中国食品药品检定研究院, 北京 100050,中国食品药品检定研究院, 北京 100050,中国食品药品检定研究院, 北京 100050,中国食品药品检定研究院, 北京 100050,中国食品药品检定研究院, 北京 100050,中国食品药品检定研究院, 北京 100050,中国食品药品检定研究院, 北京 100050 |
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| 摘 要： | 目的：设计组织六味安消胶囊含量测定的能力验证项目,评价药品检验机构对中成药指标成分含量检测的能力。方法：对参加实验室"总大黄素和总大黄酚的总量"游离大黄素和游离大黄酚的总量"测定结果进行稳健统计分析,以Z比分数评价实验室检测能力。结果：242家实验室反馈了实验结果,满意结果数为190家,满意率78.51%。针对不满意和可疑数据,结合原始记录进行技术分析,并给出建议。结论：多数参加实验室对六味安消胶囊指标成分的检测结果满意,不满意实验室应回顾操作过程,结合自身情况查找原因并进行整改。
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| 关 键 词： | 能力验证 六味安消胶囊 含量测定 稳健统计 |
| 收稿时间： | 2018/2/7 0:00:00 |
Proficiency Testing on Determination of the Content of Liuwei Anxiao Capsule |
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| He Fengyan,Wang Mingyuan,Hu Xiaoru,Liu Jing,Zhao Meng,Xiang Xinhu,Dai Zhong and Ma Shuangcheng.Proficiency Testing on Determination of the Content of Liuwei Anxiao Capsule[J].Chinese Pharmaceutical Affairs,2018,32(8):1120-1124. |
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| Authors: | He Fengyan Wang Mingyuan Hu Xiaoru Liu Jing Zhao Meng Xiang Xinhu Dai Zhong and Ma Shuangcheng |
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| Institution: | National Institutes for Food and Drug Control, Beijing 100050, China,National Institutes for Food and Drug Control, Beijing 100050, China,National Institutes for Food and Drug Control, Beijing 100050, China,National Institutes for Food and Drug Control, Beijing 100050, China,National Institutes for Food and Drug Control, Beijing 100050, China,National Institutes for Food and Drug Control, Beijing 100050, China,National Institutes for Food and Drug Control, Beijing 100050, China and National Institutes for Food and Drug Control, Beijing 100050, China |
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| Abstract: | Objective:The proficiency testing program for determination of the content of Liuwei Anxiao capsule was designed and organized to assess the proficiency of the the drug control institutions the content of chemical constituents in Chinese patent medicines. Methods:Results of the amount of total emodin and total chrysophanol and the total amount of free emodin and free chrysophanol were analyzed with robust statistical method. The proficiency of the participant laboratories was evaluated by z-score. Results:242 laboratories reported the results, of which 190 results were acceptable, accounting for 78.51%. As for the laboratories with suspicious and unacceptable results, the original records were analyzed statistically and suggestions were given. Conclusion:Majority of the participant laboratories passed the proficiency testing with acceptable results. The laboratories with unacceptable results should review the operation process so as to find the causes and rectify the relevant parts. |
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| Keywords: | proficiency testing Liuwei Anxiao capsule determination of the content robust statistics |
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