基于关联规则的2017—2019年国家药品抽检不合格分析  

Analysis of Unqualified Results of National Drug Sampling in 2017—2019 Based on Association Rules

作　　者：王瑞丽 朱嘉亮[2] 王淑玲[1] 黄志禄 WANG Ruili;ZHU Jialiang;WANG Shuling;HUANG Zhilu(College of Business Administration,Shenyang Pharmaceutical University,Shenyang 110016,China;National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]沈阳药科大学工商管理学院,沈阳110016 [2]中国食品药品检定研究院,北京102629

出　　处：《中国现代应用药学》2021年第14期1781-1787,共7页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的挖掘国家药品抽检不合格数据中的潜在信息,为国家药品抽检的开展提供参考。方法通过对2017—2019年间国家药品抽检数据进行清洗与标准化处理,得到1 816份不合格报告,通过Excel中的数据透视图表功能对不合格药品的类型、标示生产企业、检品来源分布与剂型进行可视化描述;通过SPSSmodeler18.0软件的Apriori算法对药品不合格项目与药品类别、剂型、标示生产企业所在地区、检品来源所在地区进行关联建模,得到10条有效规则。结果国家药品抽检工作为打击假劣药品提供了有效技术支撑,中药饮片、生产企业中安徽、广西、江西,抽样地区中江西、安徽、海南的不合格率高于其他地区。药品不合格项目与药品类别、药品剂型、标示生产企业所在地区、检品来源所在地区之间存在某些强关联关系。结论建议以问题为导向制定国家药品抽检计划,在假劣药处罚中引入信用管理机制,扩大药品抽检结果应用,完善国家药品抽检平台功能。OBJECTIVE To explore the potential information in the unqualified information of the national drug quality sampling and testing, and to provide references for the development of the national drug quality sampling and testing. METHODS By cleaning and standardizing the national drug quality sampling and testing data from 2017 to 2019, 1 816 non-conformance reports were obtained. The type, labeling production enterprise, inspection source distribution and dosage form of non-conforming drugs were analyzed through the data perspective chart function in Excel which performed a visual description. Through the Apriori algorithm of SPSS modeler 18.0 software, the unqualified drug items were associated with the drug type, dosage form, labeling manufacturer, and source of inspection products, and 10 effective rules were obtained. RESULTS The national drug quality sampling and testing provided effective technical support for fighting against counterfeit and inferior drugs. The unqualified rate in Anhui, Guangxi, Jiangxi regions of traditional Chinese medicine slices and manufacturing enterprises, and the sampling areas of Jiangxi, Anhui and Hainan was higher than that of other regions. There were certain strong associations between unqualified drug items and the dosage form, the label production enterprise, the source of the inspection product. CONCLUSION It is suggested to formulate a national drug quality sampling and testing plan based on problems. Introduce credit management mechanism in penalties for counterfeit and inferior drugs, expand the application of drug quality sampling and testing results, and improve the function of the national drug quality sampling and testing platform.

关 键 词：国家药品抽检 数据透视表 关联规则 APRIORI算法 

分 类 号：R951[医药卫生—药学]