Mufusama Jean-Pierre, Ndjoko Ioset Karine, Feineis Doris, Hoellein Ludwig, Holzgrabe Ulrike, Bringmann Gerhard
Institute of Organic Chemistry, University of Würzburg, Germany.
Faculté des Sciences Pharmaceutiques, Université de Kinshasa, Democratic Republic of the Congo.
Drug Test Anal. 2018 Oct;10(10):1599-1606. doi: 10.1002/dta.2420. Epub 2018 Jul 18.
In the context of post-marketing surveillance supporting public-health authorities to take evidence-based decisions to fight the spread of poor-quality medicines, the quality of antimalarial artemether-lumefantrine (AL) medicines was assessed in the Democratic Republic of the Congo (DRC). A total of 150 samples of AL-containing products was collected from private pharmaceutical outlets in 8 main cities: Goma, Kikwit, Kinshasa, Kisangani, Lubumbashi, Matadi, Mbandaka, and Mbuji-Mayi. All drug samples were successively analyzed by visual inspection, thin-layer chromatography (TLC), and high-performance liquid chromatography (HPLC) following The International Pharmacopoeia. Of the 150 collected drug samples, 3 (2%) failed the visual inspection as they had shelf lives different from those of other samples with the same brand name. Four samples (2.7%) did not pass the TLC test as they contained only 1 or even none of the 2 declared active pharmaceutical ingredients (APIs). HPLC assays showed that 46 (30.7%) samples had artemether contents below 90% and 17 (11.3%) above 110% of the content claimed on the label. For lumefantrine, 32 (21.7%) samples had contents below 90%, and 8 (5.3%) had contents above 110%. This survey in DRC gives evidence that poor-quality antimalarial medicines are widely present. Based on 3 detection techniques, the study shows the necessity to equip developing countries with modern techniques such as HPLC, which, if combined with affordable techniques like TLC, could provide a pertinent analytical strategy to combat drug counterfeiting and poor manufacturing.
在上市后监测的背景下，为支持公共卫生当局做出基于证据的决策以抗击劣质药品的传播，对刚果民主共和国（DRC）的抗疟药蒿甲醚-本芴醇（AL）的质量进行了评估。从戈马、基奎特、金沙萨、基桑加尼、卢本巴希、马塔迪、姆班达卡和姆布吉-马伊这8个主要城市的私人药店共收集了150份含AL产品的样本。所有药物样本均按照《国际药典》依次通过目视检查、薄层色谱法（TLC）和高效液相色谱法（HPLC）进行分析。在收集的150份药物样本中，有3份（2%）在目视检查中不合格，因为它们的保质期与同一品牌的其他样本不同。有4份样本（2.7%）未通过TLC测试，因为它们仅含有1种甚至不含2种宣称的活性药物成分（API）。HPLC分析表明，46份样本（30.7%）的蒿甲醚含量低于标签上声称含量的90%，17份样本（11.3%）高于110%。对于本芴醇，32份样本（21.7%）的含量低于90%，8份样本（5.3%）高于110%。刚果民主共和国的这项调查表明，劣质抗疟药品广泛存在。基于3种检测技术，该研究表明发展中国家有必要配备HPLC等现代技术，若将其与TLC等经济适用的技术相结合，可为打击假药和生产劣质药品提供相关的分析策略。
