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首页> 外文期刊>The American Journal of Tropical Medicine and Hygiene >Substandard Antimalarials Available in Afghanistan: A Case for Assessing the Quality of Drugs in Resource Poor Settings
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Substandard Antimalarials Available in Afghanistan: A Case for Assessing the Quality of Drugs in Resource Poor Settings

机译:阿富汗可提供的不合标准的抗疟药:在资源匮乏地区评估药物质量的案例

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摘要

Good-quality antimalarials are crucial for the effective treatment and control of malaria. A total of 7,740 individual and packaged tablets, ampoules, and syrups were obtained from 60 randomly selected public (N = 35) and private outlets (N = 25) in Afghanistan. Of these, 134 samples were screened using the Global Pharma Health Fund (GPHF) MiniLab (R) in Kabul with 33/126 (26%) samples failing the MiniLab (R) disintegration test. The quality of a subsample (N = 37) of cholorquine, quinine, and sulfadoxine/pyrimethamine tablets was assessed by in vitro dissolution testing following U.S. Pharmacopeia (USP) monographs at a bioanalytical laboratory in London, United Kingdom. Overall, 12/32 (32%) samples of sulfadoxine/pyrimethamine and quinine were found not to comply with the USP tolerance limits. Substandard antimalarials were available in Afghanistan demonstrating that continuous monitoring of drug quality is warranted. However, in Afghanistan as in many low-income countries, capacity to determine and monitor drug quality using methods such as dissolution testing needs to be established to empower national authorities to take appropriate action in setting up legislation and regulation.
机译:高质量的抗疟药对于有效治疗和控制疟疾至关重要。从阿富汗的60个随机选择的公共场所(N = 35)和私人场所(N = 25)中获得了总计7,740片个人和包装的片剂,安瓿和糖浆。其中,使用全球药品卫生基金(GPHF)在喀布尔的MiniLab(R)筛选了134个样品,其中有33/126(26%)个样品未通过MiniLab(R)崩解测试。根据美国药典(USP)专论在英国伦敦的生物分析实验室进行体外溶出度测试,评估了氯喹,奎宁和磺胺多辛/乙胺嘧啶片的子样品(N = 37)的质量。总体而言,发现磺胺多辛/乙胺嘧啶和奎宁的12/32(32%)样品不符合USP耐受极限。阿富汗有不合标准的抗疟药,表明有必要对药物质量进行持续监测。但是,像许多低收入国家一样,在阿富汗,需要建立使用溶出度测试等方法确定和监测药物质量的能力,以授权国家主管部门采取适当行动来制定法律和法规。

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