Department of Basic Biomedical Science, School of Pharmacy with the Division of Laboratory Medicine in Sosnowiec, Medical University of Silesia in Katowice, Kasztanowa Street 3, Sosnowiec 41-200, Poland.
Department of Biomedical Computer Systems, University of Silesia, Faculty of Computer Science and Materials Science, Institute of Computer Science, Będzińska Street 39, Sosnowiec 41-200, Poland.
Talanta. 2019 Apr 1;195:870-875. doi: 10.1016/j.talanta.2018.12.009. Epub 2018 Dec 11.
The practice of drug counterfeiting is an important challenge due to the extremely rapid growth rate of this disturbing trend and its immense potential harmfulness. According to WHO even 10% of counterfeit medicines can be exact copies of genuine medicines: they have exactly the same quantitative and qualitative composition in terms of both API and excipients. Thus, the identification of such drugs using chemical analysis methods can be very difficult or even impossible. The aim of this study was to verify the effectiveness of using computed microtomography in the identification of counterfeit medicines. The General Electric v|tome|x s microtomography system was used in the study. The recorded microtomographic scans were subjected to analysis and image processing. The following parameters of image analysis and processing were identified: mean brightness, homogeneity, contrast, quadratic tree decomposition. The original and falsified 100-mg Viagra® tablets (Pfizer) were compared. 8 original Viagra® tablets (hereinafter referred to as T) and 8 falsified tablets (hereinafter referred to as F1-F8) were tested. The range of variation for the genuine medicines against fake products was: brightness: 90.9-117.1 vs 33.8, 50.1, homogeneity: 0.84-0.92 vs 0.94-1.01 and quadratic tree decomposition for the 1 × 1 mask: 55768-58792 vs 0-439. The proposed method of microtomographic image analysis and processing enables to identify solid dosage forms, including those that are an accurate chemical copy, with high sensitivity and specificity, 94.5% and 97%, respectively. The advantage of the μCT method is its high efficiency and speed, whereas the disadvantages include the possibility of using only solid dosage forms and high equipment costs.
由于这种令人不安的趋势增长率极高且潜在危害极大，因此假药制造已成为一个重大挑战。根据世界卫生组织（WHO）的数据，甚至有 10%的假药是与真药完全相同的仿制品：在原料药和辅料方面，它们在数量和质量上完全相同。因此，使用化学分析方法来识别此类药物可能非常困难，甚至是不可能的。本研究旨在验证使用计算机微断层扫描技术识别假药的有效性。研究中使用了通用电气 v|tome|x s 微断层扫描系统。对记录的微断层扫描进行了分析和图像处理。确定了以下图像处理分析参数：平均亮度、均匀性、对比度、二次树分解。比较了原始和伪造的 100mg Viagra®片剂（辉瑞）。对 8 片原始 Viagra®片剂（以下简称 T）和 8 片伪造片剂（以下简称 F1-F8）进行了测试。正品药品与假冒产品的变化范围如下：亮度：90.9-117.1 对比 33.8、50.1；均匀度：0.84-0.92 对比 0.94-1.01；1×1 掩模的二次树分解：55768-58792 对比 0-439。所提出的微断层扫描图像分析和处理方法能够以高灵敏度和特异性（分别为 94.5%和 97%）识别固体剂型，包括那些具有准确化学复制的剂型。μCT 方法的优点是效率和速度高，缺点是只能使用固体剂型，设备成本高。
