A colorimetric field method to assess the authenticity of drugs sold as the antimalarial artesunate
A colorimetric field method to assess the authenticity of drugs sold as the antimalarial artesunate
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DOI：
10.1016/s0731-7085(00)00360-5
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发表时间：
2000-12-01
影响因子：
3.4
通讯作者：
White, NJ
中科院分区：
文献类型：
--
作者：
Green, MD;Mount, DL;White, NJ
青蒿琥酯是应用最广泛的青蒿素衍生物。这些药物在整个热带世界被越来越多地使用，是治疗耐多药疟疾的重要组成部分。最近，假冒青蒿琥酯片剂在东南亚几个国家普遍出现，对该地区的健康构成了严重威胁。我们开发了一种简单、廉价的比色法来确定青蒿琥酯片剂的真实性。这项测试是基于青蒿琥酯的碱分解产物与重氮盐耐晒红(FRTR)之间的反应。黄色的出现表明青蒿琥酯的存在。试验的特异性取决于反应的pH值。在所测试的其他抗疟药中(即青蒿素、蒿甲醚、氯喹、奎宁、伯喹、磺胺多辛和乙胺嘧啶)，只有青蒿琥酯在pH为4时呈阳性显色反应。该方法只需含50毫克青蒿琥酯标准片总重量的1%，可在10分钟内完成。该方法在东南亚获得的6片真青蒿琥酯和6片假冒青蒿琥酯上进行了测试。正品片剂中青蒿琥酯的平均含量为50.8+/-2.9毫克，而假冒片剂中不含青蒿琥酯。(C)爱思唯尔科学公司出版。
Artesunate is the most widely used of the artemisinin derivatives. These drugs are being used increasingly throughout the tropical world, and are an essential component of the treatment of multi-drug resistant malaria. The recent and widespread appearance of counterfeit artesunate tablets in several countries in Southeast Asia poses a serious threat to health in this region. We have developed a simple, inexpensive colorimetric test to determine artesunate authenticity in tablets. The test is based on a reaction between an alkali decomposition product of artesunate and a diazonium salt, fast red TR (FRTR). The appearance of a yellow color indicates the presence of artesunate. The specificity of the test is dependent on the pH of the reaction. Among other antimalarials tested, (i.e. artemisinin, artemether, chloroquine, quinine, primaquine, sulfadoxine, and pyrimethamine) only artesunate produced a positive color reaction at pH 4. The assay requires only 1% of the total weight of a standard tablet containing 50 mg of artesunate and can be completed within 10 min. The method was tested on six genuine artesunate tablets and six counterfeit artesunate tablets obtained in Southeast Asia. The average amount of artesunate in the genuine tablets was determined to be 50.8 +/- 2.9 mg while the counterfeit tablets were found to contain no artesunate. (C) Published by Elsevier Science B.V.