A comprehensive analysis of selected medicines collected from private drug outlets of Dhaka city, Bangladesh in a simple random survey.
A comprehensive analysis of selected medicines collected from private drug outlets of Dhaka city, Bangladesh in a simple random survey.
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DOI：
10.1038/s41598-021-04309-1
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发表时间：
2022-01-07
影响因子：
4.6
通讯作者：
Kimura K
中科院分区：
文献类型：
--
作者：
Rahman MS;Yoshida N;Tsuboi H;Karmoker JR;Kabir N;Schaefermann S;Akimoto Y;Bhuiyan MA;Reza MS;Kimura K
需要全面的数据来防止不合格和伪造 (SF) 药品，因为它们对人类健康构成重大风险。为了评估所选药品的质量，从孟加拉国达卡南北城市公司的私人药店随机采集了样品。样品分析包括包装的目视观察、样品的真实性、制造商的合法性和注册验证、理化分析和价格。根据药典，使用便携式拉曼光谱仪和高效液相色谱法对样品进行化学分析。样品的目视观察发现了一些差异。采集的189份埃索美拉唑（ESM）、头孢克肟（CFIX）、阿莫西林克拉维酸（CVA-AMPC）样品中，21.2%被确认为正品，91.3%被确认为合法生产厂家，2.1%的样品未经注册。样品的化学分析显示，9.5% (95% CI 5.7–14.6) 的样品是 SF。拉曼光谱分析均检测到伪造样品和同一通用品牌样品中的质量差异。总体而言，样品价格相对于国际参考价格令人满意。这项研究记录了劣质药品的可用性，表明国家药品监管机构需要立即关注。
Comprehensive data are needed to prevent substandard and falsified (SF) medicines as they pose a major risk to human health. To assess the quality of selected medicines, samples were collected from random private drug outlets of Dhaka North and South City Corporation, Bangladesh. Sample analysis included visual observation of the packaging, authenticity of the samples, legitimacy and registration verification of the manufacturer, physicochemical analysis, and price. Chemical analysis of the samples was performed using a portable Raman spectroscopy and high-performance liquid chromatography according to the pharmacopoeia. Several discrepancies were noted in the visual observation of samples. Among the 189 collected samples of esomeprazole (ESM), cefixime (CFIX), and amoxicillin-clavulanic acid (CVA-AMPC), 21.2% were confirmed to be authentic, 91.3% manufacturers were confirmed legitimate, and 2.1% of all samples were unregistered. Chemical analysis of the samples revealed that 9.5% (95% CI 5.7–14.6) of samples were SFs. Falsified samples and quality variation in the same generic branded samples were both detected by Raman spectroscopic analysis. Overall, sample prices were satisfactory relative to the international reference price. This study documents the availability of poor-quality medicines, demonstrating the need for immediate attention by the national medicine regulatory authority.
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影响因子：
3.7
作者：
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通讯作者：
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影响因子：
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通讯作者：
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