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打击假药:分析方法

Fighting falsified medicines: The analytical approach.

作者信息

Rebiere Hervé, Guinot Pauline, Chauvey Denis, Brenier Charlotte

机构信息

French National Agency for Medicines and Health Products Safety, 635 Rue de la Garenne, 34740 Vendargues, France.

French National Agency for Medicines and Health Products Safety, 635 Rue de la Garenne, 34740 Vendargues, France.

出版信息

J Pharm Biomed Anal. 2017 Aug 5;142:286-306. doi: 10.1016/j.jpba.2017.05.010. Epub 2017 May 13.

DOI:10.1016/j.jpba.2017.05.010
PMID:28531832
Abstract

Given the harm to human health, the fight against falsified medicines has become a priority issue that involves numerous actors. Analytical laboratories contribute by performing analyses to chemically characterise falsified samples and assess their hazards for patients. A wide range of techniques can be used to obtain individual information on the organic and inorganic composition, the presence of an active substance or impurities, or the crystalline arrangement of the formulation's compound. After a presentation of these individual techniques, this review puts forward a methodology to combine them. In order to illustrate this approach, examples from the scientific literature (products used for erectile dysfunction treatment, weight loss and malaria) are placed in the centre of the proposed methodology. Combining analytical techniques allows the analyst to conclude on the falsification of a sample, on its compliance in terms of pharmaceutical quality and finally on the safety for patients.

摘要

鉴于假药对人类健康的危害,打击假药已成为一个涉及众多行为主体的优先问题。分析实验室通过对假药样本进行化学特征分析并评估其对患者的危害来做出贡献。可以使用多种技术来获取有关有机和无机成分、活性物质或杂质的存在情况,或制剂化合物的晶体排列的单独信息。在介绍了这些单独的技术之后,本综述提出了一种将它们结合起来的方法。为了说明这种方法,将科学文献中的例子(用于治疗勃起功能障碍、减肥和疟疾的产品)置于所提出方法的核心位置。结合分析技术使分析人员能够就样本是否为假药、其在药品质量方面是否合规以及最终对患者的安全性得出结论。

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