质量指数评价法分析氟哌噻吨美利曲辛片质量

Quality Index Evaluation Method for Quality Analysis of Flupentixol and Melitracen Tablets

目的:研究一种药品质量综合评价方法,以对药品的生产和质量检测提供建设性意见。方法:以2008年广东省药品检验所实验室信息管理系统(LIMS)自动采集氟哌噻吨美利曲辛片198个批次的各质量项目检测数据,对其进行统计分析,并计算药品质量指数,综合分析药品质量。结果:各质量项目中含量均匀度项对氟哌噻吨美利曲辛片的质量影响最大,含量测定项次之,崩解时间项影响最小。结论:LIMS是采集大批量药品数据的强有力工具,药品质量指数能够有效评价药品的质量。

OBJECTIVE： To explore a comprehensive drug quality evaluation method so as to provide constructive suggestions for the production and quality inspection of drugs. METHODS ： The quality inspection data of 198 batches of flupentixol and melitracen tablets collected automatically by Laboratory Information Management System（LIMS） in Guangdong institute for drug control in 2008 were analyzed statistically, and the drug quality indexes were computed and the drug quality was analyzed comprehensively. RESULTS： Of all the quality items, the content uniformity showed the maximum impact on the quality of the tablets, followed by the content determination item, with disintegration time item showing the least impact on the quality of the tablets. CONCLUSIONS： LIMS is a powerful tool in collecting large quantities of drug data, and the quality index serves as an effective means for the evaluation of drug quality.