中国药房2016，Vol.27Issue(31)：4321-4324,4.DOI:10.6039/j.issn.1001-0408.2016.31.01
模糊综合评价法评价硫酸阿米卡星注射液生产过程的安全性
Safety Assessment of Amikacin Sulfate Injection Production Process by Fuzzy Comprehensive Evaluation
摘要
Abstract
OBJECTIVE:To provide reference for eliminating the safety accidents occurred in the production process of Amika-cin sulfate injection (called“Amikacin”in short). METHODS:The safety assessment index system of Amikacin production pro-cess with hierarchical structure was established,and the weight of each index was calculated by analytic hierarchy process(AHP). Then,fuzzy comprehensive evaluation(FCE)was used to assess the safety of Amikacin production process in a large-scale pharma-ceutical enterprises from southwest China. The improvement suggestions were put forward according to assessment results(as stan-dard score of related index). RESULTS & CONCLUSIONS:The safety evaluation index system of Amikacin production process is divided into 3 levels of target layer,criterion layer and index layer;criterion layer included 6 first indicators of personnel factor, technological factor,material factor,equipment factor,environmental factor and management factor;index layer included 24 sec-ondary indicators of staff quality,process complexity,inflammability,equipment location,workshop internal environment and safe-ty management,etc. AHP demonstrated that the weight of 6 first indicators were 0.291,0.066,0.109,0.109,0.045,0.308,respec-tively. FCE showed that standard scores of personnel factor,process factor,equipment factor and management factor were higher than others,being 0.804,0.828,0.816,0.818,respectively,which indicated good safety. The standard scores of material factor and environmental factor were lower,being 0.772 and 0.695,which indicated general safety. On the whole,standard score of FCE as-sessment of Amikacin production process was 0.828,indicating good safety. Because the safety assessment of material factor and en-vironmental factor are lower than others,it is suggested to strengthen the valves,flanges and gaskets check and real-time monitor-ing,and improve the lighting and ventilation facility.关键词
硫酸阿米卡星注射液/生产过程/安全评价/模糊综合评价法/层次分析法Key words
Amikacin sulfate injection/Production process/Safety assessment/Fuzzy comprehensive evaluation/Analytic hier-archy process分类
医药卫生引用本文复制引用
范佳,姚波,卓凤萍,傅亚,张洪兰..模糊综合评价法评价硫酸阿米卡星注射液生产过程的安全性[J].中国药房,2016,27(31):4321-4324,4.基金项目
重庆市科委自然科学基金（No.cstc2014jcyiA10029）；重庆科技学院研究生科技创新项目 （）
