基于趋势分析-灰色关联分析方法对药品口岸检验中检验策略优化的探讨  

Optimization of imported drug testing strategy based on trend analysis-the grey correlation analysis

作　　者：王岩[1,2] 江滨[1] WANG Yan JIANG Bin(School of Pharmaceutical Sciences, Peking University, Beijing 100191, China National Institutes for Food and Drug Control, Beijing 100050, China)

机构地区：[1]北京大学药学院,北京100191 [2]中国食品药品检定研究院,北京100050

出　　处：《中国新药杂志》2016年第20期2305-2312,共8页Chinese Journal of New Drugs

摘　　要：目的:分析进口药品的质量趋势并找出质量标准中各质控项目间的关联性,为检验资源的合理分配及在常规检验中有条件优化检验项目的合理实施提供理论支持。方法:选取连续生产(进口)批次的进口药品作为研究对象,利用趋势分析评价质量变化情况,从中选择质量稳定的产品,采用灰色系统理论,将药品质量标准中各定量质控项目作为一个灰色系统,以含量质控项作为该系统的特征指标,运用灰色关联分析法,计算出其他定量质控项目相对于系统特征指标的灰色关联度。结果:所选连续生产(进口)的药品质量较为稳定,其标准中各定量质控项目间的关联性存在差异。结论:通过趋势分析-灰色关联度分析方法,可为药品口岸检验中检验策略优化和提高检验经济效益提供新思路。Objective： To investigate the quality trend of imported drugs and find out the correlation among individual test items described in drug quality standards,thus provide theoretical support for rational allocation of resources and optimization of routine test strategy. Methods： Products with consistent quality were selected from successive batches of imported drugs by using trend analysis method; assay was used as the characteristic index of the grey system,and the relative grey correlation degree between other quantitative quality control items and assay were calculated using the grey correlation analysis methodology. Results： The qualities of the selected continuous batches of imported drug products were relatively stable,and variability was observed for the correlation among the quantitative quality control items. Conclusion： Through the trend analysis and grey correlation analysis,a potential new approach was established to optimize and improve the economic efficiency of imported drug test.

关 键 词：趋势分析 灰色关联度分析 进口药品 检验项目 优化 

分 类 号：R956[医药卫生—药学]