A Nationwide Survey of the Quality of Antimalarials in Retail Outlets in Tanzania
A Nationwide Survey of the Quality of Antimalarials in Retail Outlets in Tanzania
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DOI：
10.1371/journal.pone.0003403
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发表时间：
2008-10-15
期刊：
影响因子：
3.7
通讯作者：
Abdulla, Salim
中科院分区：
文献类型：
--
作者：
Kaur, Harparkash;Goodman, Catherine;Abdulla, Salim
导言：在撒哈拉以南非洲国家，零售药品通常用于治疗发烧和疟疾。小规模的研究表明，质量低劣的抗疟药物在整个区域很普遍，但没有全国性的数据，无法得出关于非洲社区质量低劣药物供应程度的普遍结论。本研究的目的是评估抗疟药的质量，从零售店在大陆Tanzan.Methods和调查结果：我们系统地购买了口服抗疟药片剂的样品从零售店在2005年在坦桑尼亚大陆的21个区。共收集了1080种抗疟制剂，包括679种抗疟药样品（394种磺胺甲氧嘧啶/乙胺嘧啶和285种磺胺甲氧吡嗪/乙胺嘧啶）、260种阿莫地喹样品、63种奎宁样品和51种青蒿素衍生物样品。通过基于实验室的分析评估了304种产品的系统子样品的质量，以根据已出版的美国药典（USP）中待测特定片剂的字母组合确定活性成分的含量和溶出曲线。对于没有已发表的分析会标的产品，仅根据活性成分的含量进行评估。总的来说，38个或12.2%的样品被发现质量差。在测试的抗叶酸抗疟疾药物中，13.4%的药物通过使用高效液相色谱法（HPLC）进行溶出度和含量分析发现质量较差。近四分之一（23.8%）的奎宁片剂不符合溶出度和定量分析的容许限度。阿莫地喹药物的质量相对较好，但仍不可接受，因为7.5%未符合溶出度分析的容许限度。青蒿素衍生物的配方都含有规定的活性成分的量时，单独使用HPLC.Conclusions分析：低于标准的抗疟制剂广泛存在于坦桑尼亚在本研究的时候。没有检测到不含任何量的所述活性成分的产品。奎宁和磺胺嘧啶/乙胺嘧啶产品供应最广泛，也最有可能质量差。全国各地都发现了不合格产品，并贴上了国内和国际制造商生产的标签。随着药品零售部门作为抗疟制剂供应渠道的扩大，在全国范围内定期监测其质量的必要性将变得越来越重要。
Introduction: Retail pharmaceutical products are commonly used to treat fever and malaria in sub-Saharan African countries. Small scale studies have suggested that poor quality antimalarials are widespread throughout the region, but nationwide data are not available that could lead to generalizable conclusions about the extent to which poor quality drugs are available in African communities. This study aimed to assess the quality of antimalarials available from retail outlets across mainland Tanzania.Methods and Findings: We systematically purchased samples of oral antimalarial tablets from retail outlets across 21 districts in mainland Tanzania in 2005. A total of 1080 antimalarial formulations were collected including 679 antifol antimalarial samples (394 sulfadoxine/pyrimethamine and 285 sulfamethoxypyrazine/pyrimethamine), 260 amodiaquine samples, 63 quinine samples, and 51 artemisinin derivative samples. A systematic subsample of 304 products was assessed for quality by laboratory based analysis to determine the amount of the active ingredient and dissolution profile by following the published United States Pharmacopoeia (USP) monogram for the particular tablet being tested. Products for which a published analytical monogram did not exist were assessed on amount of active ingredient alone. Overall 38 or 12.2% of the samples were found to be of poor quality. Of the antifolate antimalarial drugs tested 13.4% were found to be of poor quality by dissolution and content analysis using high-performance liquid chromatography (HPLC). Nearly one quarter (23.8%) of quinine tablets did not comply within the tolerance limits of the dissolution and quantification analysis. Quality of amodiaquine drugs was relatively better but still unacceptable as 7.5% did not comply within the tolerance limits of the dissolution analysis. Formulations of the artemisinin derivatives all contained the stated amount of active ingredient when analysed using HPLC alone.Conclusions: Substandard antimalarial formulations were widely available in Tanzania at the time of this study. No products were detected that did not contain any amount of the stated active ingredient. Quinine and sulfadoxine/pyrimethamine products were the most widely available and also the most likely to be of poor quality. Substandard products were identified in all parts of the country and were labeled as made by both domestic and international manufacturers. With the expansion of the retail pharmaceutical sector as a delivery channel for antimalarial formulations the need for regular nationwide monitoring of their quality will become increasingly important.