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

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.

1 ZHANG Xue-bo(张学博),YIN Li-hui(尹利辉).Study of near-infrared spectroscopic conformity test for rapid examination of drug quality(近红外光谱一致性检验方法用于快速判断药品质量的研究).Chin J Pharm Anal(药物分析杂志),2011,31(3):603
2 YAN Yan-lu(严衍禄).The Basic and Application of the NIR Spectrum(近红外光谱分析基础与应用).Beijing(北京):China Light Industry Press(中国轻工业出版社),2005.20
3 LU Wan-zhen (陆婉珍).Modern Near Infrared Spectroscopy Analytical Technology(Second Edition) (现代近红外光谱分析技术第二版).Beijing(北京):China Petrochemical Press(中国石化出版社),2006.87
4 DAI Yong(戴涌),LI Xiao-an(李小安),LIU Xue-feng(刘雪峰), et al.Conformity test on nitrofurantoin enteric tablets by near infrared absorption spectromotry(运用近红外光谱法对呋喃妥因肠溶片进行一致性检验).Chin J Pharm Anal(药物分析杂志),2010,30(11):2153
5 LIU Wei(刘伟),FAN Ke-qing(范可青),BAO Yan-chun(包艳春),et al.Research of conformity test on penicillin V potassium tablets by near infrared absorption spectromotry(运用近红外光谱法对青霉素V钾片一致性检验的研究).Chin J Pharm Anal (药物分析杂志),2009,29(1):125