Departamento de Produtos Farmacêuticos, Universidade Federal de Minas Gerais, Brazil.
Rev Soc Bras Med Trop. 2011 Oct;44(5):582-6. doi: 10.1590/s0037-86822011000500010.
The emergence of drug resistance is one of the main problems concerning malaria treatment. The use of counterfeit and/or substandard antimalarial drugs can contribute to the development of parasite resistance. Thus, the aim of this study was to evaluate the quality of antimalarial drugs distributed in Brazil.
Samples containing chloroquine phosphate, mefloquine hydrochloride, primaquine phosphate, and quinine sulfate tablets were delivered to the Rio de Janeiro central storeroom (CENADI), state storerooms (SS), and Basic Health Units (BHUs) in the north region of Brazil - a total of 10 sample sets. After 5 months of storage, the samples were collected, and in vitro quality control analyses according to official and published methods were performed.
Inadequate drug storage conditions were found in two SS and in all BHUs evaluated. There were no quality deviations found in the chloroquine samples. The quinine samples exhibited weight variation above the allowed limits. The primaquine samples were found to have packaging deficiency. The release of mefloquine in samples from some regions showed a statistically significant difference when compared with the CENADI samples.
It is important to periodically evaluate the quality and storage conditions of essential drugs. The quality deviations found with the primaquine and quinine samples are not related to storage conditions and must be addressed urgently. The decreased mefloquine release from tablets is related to formulation problems or influenced by inadequate storage conditions, prompting further investigation. Even with the mentioned problems, the samples would probably not contribute to resistant parasite selection.
耐药性的出现是疟疾治疗的主要问题之一。假冒和/或劣质抗疟药物的使用可能导致寄生虫耐药性的发展。因此，本研究旨在评估在巴西分发的抗疟药物的质量。
含有磷酸氯喹、盐酸甲氟喹、磷酸伯氨喹和硫酸奎宁片的样品被送到巴西北部地区的里约热内卢中央仓库（CENADI）、州仓库（SS）和基层卫生单位（BHUs）——共 10 个样品组。储存 5 个月后，收集样品，并按照官方和已发表的方法进行体外质量控制分析。
在两个 SS 和所有评估的 BHUs 中都发现了不合适的药物储存条件。氯喹样品没有质量偏差。奎宁样品的重量变化超过了允许的限度。发现伯氨喹样品包装有缺陷。一些地区的样品中释放的甲氟喹与 CENADI 样品相比存在统计学显著差异。
定期评估基本药物的质量和储存条件非常重要。发现的伯氨喹和奎宁样品的质量偏差与储存条件无关，必须紧急解决。从片剂中释放的甲氟喹减少与配方问题有关，或受储存条件的影响，需要进一步调查。即使存在上述问题，这些样品也不太可能导致耐药寄生虫的选择。
