近红外光谱一致性检验方法在艾滋病防治药品供应链全程质量监控中的应用  

Application of near-infrared spectroscopic conformity test in the quality monitor of AIDS drugs in complete supply chain

作　　者：谭家群 秦黎明 张锐[3] 

机构地区：[1]驻马店市食品药品监督管理局,驻马店463000 [2]驻马店市食品药品检验所,驻马店463000 [3]中国食品药品检定研究院,北京100050

出　　处：《药物分析杂志》2012年第8期1479-1481,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:监测艾滋病防治药品在供应链中各个流通环节的质量变化,保证艾滋病人用药安全有效。方法:采集供应链起点的药品建立近红外光谱一致性模型,对供应链下游各个环节存药网点的药品进行跟踪监测。结果:共跟踪监测1208批药品,未发现质量不合格的药品。结论:本方法快速可靠,应用在药品检测车上实现了对艾滋病防治药品质量的全程有效监测。Objective：To monitor the quality of AIDS drugs in the entire supply chain to guarantee the safety and efficacy of these drugs.Methods：A near-infrared spectroscopic conformity model was built by collecting the drugs from the beginning of the supply chain to monitor the drugs in every branch downstream the chain.Results：A total of 1208 batches of AIDS drugs were monitored,and none of them was counterfeit.Conclusion：The method is rapid and reliable,and its application in mobile labs can ensure an effective quality monitor of AIDS drugs in the entire supply chain.

关 键 词：近红外光谱 一致性检验 艾滋病防治药品 运输链质量监测 药品检测车 硫酸茚地那韦 拉米夫定 奈韦拉平 齐多夫定 去羟肌苷 依非韦伦 司他夫定 

分 类 号：R917[医药卫生—药物分析学]