基于智能手机的常用处方药有效成分快速图像读取质量评估——赞比亚卢萨卡

J. Nyirenda
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摘要

第三世界国家受到不合格治疗药物供应的困扰,由于缺乏强有力的质量检测设施,许多这些药物都在药房和各种销售点进行非处方购买。为了保证质量,可以使用简单而信息丰富的检测方法,其中之一是高效薄层色谱法。采用minilab方案,分别对赞比亚大学诊所和从赞比亚卢萨卡周边不同药店随机购买的药品进行了高效薄层色谱(HPTLC)、智能手机薄层色谱软件图像采集和免费软件数字增强薄层色谱(DeTLC)分析。通过与标准的延迟因子比较来评估药物质量,并使用DeTLC软件进行图像分析得出的最大K强度来比较大约百分比的有效成分含量。将斑点归一化至100%斑点,平均值和标准差分别为:阿替奈尔(85.6±0.5)、环丙沙星(95.6±1.1)、酮康唑(78.2±1.1)、甲苯达唑(95.5±1.1)、奈韦拉平(96.7±1.1)、青霉素v(100.5±1.1)、奎宁(92.9±1.1)、利福平(99.3±0.7)、异烟肼(72.0±4.1)。所有被检药物的有效成分浓度均在可接受范围内(Rf误差为0 ~ 5.3%)。因此,简单可靠的HPTLC方法与简单易用的数字成像软件相结合,提供了一种快速检查所配药物质量的手段。
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Rapid Smartphone-based Image Reading for Assessing Quality of Active Pharmaceutical Ingredients of Commonly Prescribed Drugs-Lusaka Zambia
Third world countries suffer from supply of substandard therapeutic drugs and due to lack of robust quality testing facilities, many of these drugs find themselves in the dispensaries and various outlets for over the counter purchase. In order to ensure quality, simple yet informative tests are available and one of them is high performance thin layer chromatography. High Performance Thin Layer Chromatography (HPTLC) coupled with image acquisition by TLC software application on a smart phone and analysis by freeware Digitally enhanced Thin Layer Chromatography (DeTLC) respectively was performed using the minilab protocols for assessing quality of drugs dispensed at the University of Zambia clinic as well as drugs randomly bought from different pharmacies around Lusaka, Zambia. The quality of drugs was assessed by comparing retardation factors with standards and approximate percent active ingredient amounts were compared using the maximal K intensities derived by the DeTLC software for image analysis. Normalizing the spots to the 100% spot, mean values with respective standard deviations were : atenelol (85.6±0.5), ciprofloxacin (95.6±1.1), ketoconazole (78.2±1.1), mebendazole (95.5±1.1), nevirapine (96.7±1.1), penicillin v (100.5±1.1), quinine (92.9±1.1), rifampicin (99.3±0.7) and isoniazid (72.0±4.1). All the drugs tested were within the acceptable range of concentrations of the active pharmaceutical ingredient ( 0 to 5.3% Rf error). Thus, the simple robust HPTLC method coupled with simple to use digital imaging software provides a quick means to check on quality of the drugs dispensed.
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