Wilson Benjamin K, Kaur Harparkash, Allan Elizabeth Louise, Lozama Anthony, Bell David
Intellectual Ventures Laboratory, Bellevue, Washington.
London School of Hygiene and Tropical Medicine, London, United Kingdom.
Am J Trop Med Hyg. 2017 May;96(5):1117-1123. doi: 10.4269/ajtmh.16-0904. Epub 2017 May 13.
AbstractPoor-quality medicines are a major problem for health-care systems in resource-poor settings as identifying falsified medicines requires a complex laboratory infrastructure such as a Medicines Quality Control Laboratory. We report here an evaluation of a low-cost, handheld near-infrared spectrometer (NIRS) device by analyzing a library of artemisinin-based combination therapy (ACT) medicines to determine its usefulness as a drug-screening tool. The "SCiO" research prototype device was used to collect NIR spectra of a library of ACT and artesunate monotherapy medicine samples previously collected in Bioko Island and Equatorial Guinea and Kintampo, Ghana. The quality of these samples had been categorized as falsified, substandard, and quality assured based on the amount of stated active pharmaceutical ingredients detected using high-performance liquid chromatography photodiode array. Numerical analyses were performed on the NIR spectra to assess the usefulness of NIR to identify falsified and substandard medicines. The NIRS device was successful at detecting falsified medicines in all cases where the library contained both quality assured and falsified medicines of the same stated brand of medicines. The NIRS device was successful at identifying substandard amounts of artesunate but not amodiaquine in the ACT samples ( = 15) of artesunate-amodiaquine. This work reveals that this low-cost, portable NIRS device is promising for screening ACTs for falsified samples and could enable widespread drug screening at all points of the health system.
摘要
劣质药品是资源匮乏地区医疗系统面临的一个主要问题，因为识别假药需要复杂的实验室基础设施，如药品质量控制实验室。我们在此报告对一种低成本手持式近红外光谱仪（NIRS）设备的评估，通过分析青蒿素联合疗法（ACT）药品库来确定其作为药物筛选工具的效用。“SCiO”研究原型设备用于收集先前在比奥科岛、赤道几内亚以及加纳金坦波收集的ACT和青蒿琥酯单一疗法药品样本库的近红外光谱。这些样本的质量已根据使用高效液相色谱光电二极管阵列检测到的规定活性药物成分的含量被分类为假药、不合格药和质量有保证的药。对近红外光谱进行了数值分析，以评估近红外光谱在识别假药和不合格药品方面的效用。在药品库中同时包含同一指定品牌的质量有保证的药品和假药的所有情况下，NIRS设备都成功检测出了假药。在青蒿琥酯 - 阿莫地喹的ACT样本（ = 15）中，NIRS设备成功识别出了青蒿琥酯含量不合格的情况，但未能识别出阿莫地喹含量不合格的情况。这项工作表明，这种低成本、便携式的NIRS设备在筛选ACT假药样本方面很有前景，并且可以在卫生系统的各个环节实现广泛的药物筛选。
