Characterization of counterfeit artesunate antimalarial tablets from southeast Asia
Characterization of counterfeit artesunate antimalarial tablets from southeast Asia
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DOI：
10.4269/ajtmh.2006.75.804
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发表时间：
2006-11-01
影响因子：
3.3
通讯作者：
Fernandez, Facundo M.
中科院分区：
文献类型：
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作者：
Hall, Krystyn Alter;Newton, Paul N.;Fernandez, Facundo M.
在东南亚，重要的抗疟药物青蒿琥酯的假药普遍存在，这是一个重大的公共卫生问题。为了评估这一问题的严重性，我们用液相色谱联用质谱法定量了青蒿琥酯片中有效成分的含量。该方法结合对包装的分析，将片剂分为正品、不合格或假冒，并验证了比色快速红色TR测试的结果。23份假青蒿琥酯样品中有8份（35%）含有错误的有效成分，经鉴定为不同的红霉素和扑热息痛。拉曼光谱在23个假样品中的9个（39%）中鉴定出碳酸钙为赋形剂。多变量无监督模式识别结果显示，青蒿琥酯类假药主要有两类，一类是贴有伪造箔贴、含有碳酸钙、红霉素和扑热息痛的假药，另一类是贴有伪造全息图、含有淀粉但没有红霉素或扑热息痛的假药。
In southeast Asia, the widespread high prevalence of counterfeits tablets of the vital antimalarial artesunate is of great public health concern. To assess the seriousness of this problem, we quantified the amount of active ingredient present in artesunate tablets by liquid chromatography coupled to mass spectrometry. This method, in conjunction with analysis of the packaging, classified tablets as genuine, substandard, or fake and validated results of the colorimetric Fast Red TR test. Eight (35%) of 23 fake artesunate samples contained the wrong active ingredients, which were identified as different erythromycins and paracetamol. Raman spectroscopy identified calcium carbonate as an excipient in 9 (39%) of 23 fake samples. Multivariate unsupervised pattern recognition results indicated two major clusters of artesunate counterfeits, those with counterfeit foil stickers and containing calcium carbonate, erythromycin, and paracetamol, and those with counterfeit holograms and containing starch but without evidence of erythromycin or paracetamol.