Green Michael D, Hostetler Dana M, Nettey Henry, Swamidoss Isabel, Ranieri Nicola, Newton Paul N
Am J Trop Med Hyg. 2015 Jun;92(6 Suppl):8-16. doi: 10.4269/ajtmh.14-0832. Epub 2015 Apr 20.
The availability of falsified antimalarial drugs can be reduced with effective drug regulatory agencies and proper enforcement. Fundamental to these agencies taking action, rapid identification must be made as soon as they appear in the market place. Since falsified antimalarials occur mostly in developing countries, performing drug analysis presents itself with unique challenges. A fundamental factor in choosing a useful technique is affordability and simplicity. Therefore, we suggest a three-tiered drug evaluation strategy for identifying a falsified drug in resource-poor areas. Tier I is a simple comparison of a tablet's weight and dimensions with official specifications. Tier II uses inexpensive photometric devices (laser and fluorescence) to evaluate a tablet. Suspicious samples from Tier I and II assessments are then subjected to a colorimetric assay for active ingredients identification and quantification. In this article, we evaluate a novel colorimetric assay for the simultaneous assessment of both lumefantrine and artemether in co-formulated Coartem™ tablets, and integrate the method with two novel, low-cost, fluorescence and laser photometric devices. Image analysis software is used for the assessments. Although artemether-lumefantrine is used as an example, the strategy may be adapted to other medicines.
通过有效的药品监管机构和适当的执法行动,可以减少假冒抗疟药物的供应。这些机构采取行动的关键是,一旦假冒抗疟药物出现在市场上,必须尽快进行快速识别。由于假冒抗疟药物大多出现在发展中国家,进行药品分析面临着独特的挑战。选择一种有用技术的一个基本因素是可承受性和简易性。因此,我们建议采用一种三层药品评估策略,用于在资源匮乏地区识别假冒药品。第一层是将片剂的重量和尺寸与官方规格进行简单比较。第二层使用廉价的光度测量设备(激光和荧光)来评估片剂。然后,对第一层和第二层评估中可疑的样品进行比色测定,以识别和定量活性成分。在本文中,我们评估了一种新型比色测定法,用于同时评估复方蒿甲醚片(Coartem™)中蒿甲醚和本芴醇的含量,并将该方法与两种新型、低成本的荧光和激光光度测量设备相结合。使用图像分析软件进行评估。尽管以蒿甲醚-本芴醇为例,但该策略可适用于其他药品。