Medi-Quality Security Institute (MQS), Graduate School of Medical Sciences, Kanazawa University, Kanazawa, 920-1192, Japan.
AI Hospital/Macro Signal Dynamics Research and Development Center, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa, Japan.
Sci Rep. 2022 Jan 7;12(1):234. doi: 10.1038/s41598-021-04309-1.
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.
全面的数据对于防止劣药和假药（SF）至关重要，因为它们对人类健康构成重大风险。为了评估选定药品的质量，从孟加拉国达卡市北部和南部市公司的随机私人药店采集了样本。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、物理化学分析以及价格。根据药典，使用便携式拉曼光谱和高效液相色谱法对样品进行化学分析。在对样品的目视观察中注意到了几个差异。在所采集的 189 个埃索美拉唑（ESM）、头孢克肟（CFIX）和阿莫西林克拉维酸（CVA-AMPC）样本中，有 21.2%被确认为真品，91.3%的制造商被确认为合法，所有样本中有 2.1%未注册。样品的化学分析显示，9.5%（95%置信区间 5.7-14.6）的样品为 SF。拉曼光谱分析检测到假冒样品和同一通用品牌样品的质量变化。总体而言，相对于国际参考价格，样品价格令人满意。本研究记录了劣质药品的可获得性，表明国家药品监管机构需要立即关注。
