French National Agency for Medicines and Health Products Safety, Laboratory Controls Division, 635 rue de la Garenne, 34740 Vendargues, France.
French National Agency for Medicines and Health Products Safety, Laboratory Controls Division, 635 rue de la Garenne, 34740 Vendargues, France.
Talanta. 2019 Apr 1;195:490-496. doi: 10.1016/j.talanta.2018.11.051. Epub 2018 Nov 27.
Falsified medical products are increasingly prevalent on markets, threatening the health of patients. This study describes the benefits of Energy Dispersive X-Ray Fluorescence (ED-XRF) spectroscopy and chemometrics thus highlighting the importance of conducting inorganic analyses on falsified products. The XRF spectrum is a fingerprint containing the contribution of all chemical substances included in a suspect sample's formulation. Multivariate analysis of XRF spectra, using a properly validated classification model, allows for the authentication of suspect samples. The method is rapid, relying on multi-elemental measurements and involving minimal sample preparation. This methodology provided valuable information about samples inorganic composition and enabled the detection of falsifications of several sample types, including medicine, food supplement and cosmetic samples. Five suspect samples of Plavix® were investigated, and their XRF spectra were studied using chemometrics (Principal Component Analysis and Soft Independent Modelling of Class Analogies). A classification model was validated with positive and negative samples, and four suspect samples were identified as being falsified, whilst the fifth was concluded as an authentic medicine. ED-XRF spectroscopy was also applied on another medicine, a food supplement and three cosmetic samples, and high level of zinc was detected in the second sample and mercury was identified in the last. Estimation of the zinc content was possible using the fundamental parameters method. ED-XRF spectroscopy allows the analyst to conclude on the falsification of the samples and then to assess the harm to patient health.
假冒伪劣医疗产品在市场上日益泛滥，威胁着患者的健康。本研究描述了能量色散 X 射线荧光（ED-XRF）光谱和化学计量学的优势，突出了对假冒产品进行无机分析的重要性。X 射线荧光光谱是包含嫌疑样品配方中所有化学物质贡献的指纹。使用经过适当验证的分类模型对 X 射线荧光光谱进行多元分析，可以实现嫌疑样品的认证。该方法快速可靠，依赖于多元素测量，且仅需少量样品制备。该方法提供了有关样品无机成分的有价值信息，并能够检测出多种类型的假冒样品，包括药品、食品补充剂和化妆品样品。对五个 Plavix®嫌疑样品进行了调查，并使用化学计量学（主成分分析和类模拟软独立建模）对其 X 射线荧光光谱进行了研究。使用正、负样本对分类模型进行了验证，鉴定出四个嫌疑样品为假冒产品，而第五个则为正品药品。ED-XRF 光谱还应用于另一种药品、一种食品补充剂和三种化妆品样品，在第二个样品中检测到高浓度的锌，在最后一个样品中检测到汞。使用基本参数法可以对锌含量进行估计。ED-XRF 光谱可以让分析人员判断样品是否为假冒产品，然后评估其对患者健康的危害。
